The Patient Advocacy Groups that Accept the Most Big Pharma Money

Eight out of ten patient advocacy groups accept money from drug and medical device companies. Are these good natured corporate donations, or just another way that Big Pharma exerts their influence beyond corporate walls?

Pharmaceutical donations make up more than half of the yearly income of some patient advocacy groups.

That question isn’t an easy one to answer. But the first step in understanding how large of a role pharmaceutical companies play in organizations like the American Diabetes Association or the American Heart Association is to follow the money.

Pharmaceutical donations make up more than half of the yearly income of some patient advocacy groups, according to a 2017 study published in the New England Journal of Medicine. But because there are few reporting policies, it is hard for the public to determine whether or not corporate donations may be affecting the credibility of the patient groups they rely on and donate to.

Kaiser Health News wants to change that. Their Pre$cription for Power database compiles all of the donations patient groups receive from pharmaceutical and medical device companies. We took a closer look at the patient groups that received the most corporate donations.

Patient Access Programs That Accept Most Pharma $ 

1) Patient Access Network Foundation (PAN): $31,407,500 

Mission: PAN offers patients grants to help them afford medication for 55 different diseases.

Largest donations:

  • Pfizer—$16,870,000
  • AbbVie—$14,537,500

2) Patient Advocate Foundation (PAF): $13,953,440

Mission: PAF helps patients resolve health insurance, medical debt, and employment issues related to their illnesses.

Largest donations:

  • Eli Lilly and Co.—$9,500,000
  • Pfizer Inc.—$3,290,000

3) Healthwell Foundation: $7,475,000

Mission: Healthwell Foundation provides financial assistance to help cover co-pays, premiums, deductibles, and out-of-pocket medical expenses.

Largest donations:

  • Bristol-Myers Squibb—$6,425,000
  • Merck & Co.—$1,000,000

4) The Assistance Fund Inc.: $2,150,000

Mission: The Assistance Fund offers advanced therapies, education, and financial aid for critically and chronically ill patients.

Largest donations:

  • Merck & Co.—$2,150,000

Donating Money Instead of Lowering Drug Prices?

Patient access programs, or drug access programs, help underinsured patients pay for the medications they need. Typically, patients must meet stringent income requirements in order to qualify for funding through a drug access program, so the pool of patients that these programs actually help is fairly small.

The majority of drug access programs are funded directly by drug manufacturers, but these donations are far from being altruistic. Instead of lowering drug prices and solving the need for drug access programs entirely, drug companies often donate money to these nonprofits. The donations provide good PR for drug companies while helping ensure that drug prices (and profits) stay high.

Patient Advocacy Groups That Accept Most Pharma $  

1) Conquer Cancer Foundation of ASCO: $4,895,725

Mission: The Conquer Cancer Foundation funds breakthrough cancer research, and provides cancer patients and the medical community with knowledge and resources.

Largest donations:

  • Pfizer—$2,060,000: Pfizer’s cancer drugs include Ibrance, Sutent, Xalkori, and Inlyta.
  • Eli Lilly and Co.—$978,000: Cancer drugs include Alimta, Cyramza, Erbitux, Gemzar, Lartruvo, Portrazza, and Verzenio.

Top donors Pfizer and Eli Lilly are among the top 10 largest oncology drug manufacturers, making it no surprise why they would want to support a cancer foundation. Fellow donors Merck, Bristol-Myers Squibb, Johnson & Johnson are also among the top 10 cancer drug companies.

2) American Diabetes Association: $3,856,993

Mission: The ADA seeks to help prevent and cure diabetes and improve the lives of people affected by the disease.

Largest donations:

  • Eli Lilly and Co.—$2,924,403: Eli Lilly’s diabetes drugs include insulin and non-insulin drugs like Humalog, Humulin, Jardiance, and Byetta—now sold by Amylin.
  • Johnson & Johnson—$386,595: Sells glucose meters.
  • Merck & Co.—$317,000: Diabetes drugs include Januvia, Janumet, Kombiglyze XR, and Onglyza.

The American Diabetes Association (ADA) has a history of accepting money from questionable donors. They came under fire for accepting money from sugary food companies like Coca-Cola and Cadbury Schweppes, the manufacturer of Dr Pepper and cadbury eggs. In exchange for Cadbury’s $1.5 million donation, the company received permission to use ADA’s label on their diet drinks.

Taking money from corporations with poor reputations is one thing, but some critics argue that these donations may create a conflict of interest for the ADA.

The ADA recommended the drug Jardiance for people with type 2 diabetes and cardiovascular disease in their type 2 diabetes guidelines for 2017. These recommendations, critics point out, certainly benefit ADA’s largest donor and manufacturer of Jardiance: Eli Lilly.

This isn’t the first time the association’s recommendations and guidelines have ultimately benefited drug companies. In 2003 and in 2010, they lowered the guidelines for prediabetes (a precursor to type 2 diabetes), meaning that more people were considered to be prediabetic and likely to take a medication to help regulate their glucose levels.

The U.S. has one of the lowest prediabetes benchmarks of any other country. Based on their guidelines, one in three Americans (86 million people) have prediabetes. The ADA and the CDC have called it a public health crisis, and certainly the climbing obesity rates in the U.S. are a concern. But, some groups, like the American College of Physicians, have argued that the guidelines are too aggressive, and that they may cause some patients to unnecessarily take medication when lifestyle changes are more appropriate.

3) Arthritis Foundation: $3,271,214

Mission: The Arthritis Foundation helps patients conquer everyday battles by providing information and resources, access to optimal care, advancements in science, and community connections.

Largest donations:

  • AbbVie—$1,567,000: AbbVie sells autoimmune disorder drug Humira—the highest-grossing drug in the U.S.
  • Bristol-Myers Squibb$855,650: Sells autoimmune disorder drug Orencia.

4) American Heart Association: $3,259,054

Mission: Helps provide appropriate cardiac care in an effort to reduce disability and deaths caused by cardiovascular disease and stroke.

Largest donations:

  • Bristol-Myers Squibb—$1,964,300: Bristol-Myers Squibb sells popular blood thinner Coumadin (warfarin), and co-markets blood thinners Eliquis and Plavix.
  • Abbott Laboratories—$432,525: Sells cardiovascular medical devices, like coronary stents.

Similar to the ADA, the American Heart Association (AHA) has been questioned for publishing health guidelines that seem to favor drug companies. In 2017, they lowered what they previously considered to be “healthy” blood pressure levels, resulting in the number of patients considered to have mild hypertension to increase by 26.8%.

A 2014 study published in the journal BMJ showed that treating prehypertension with medication is often ineffective and unnecessary. Given these results, the AHA’s guidelines do not appear to benefit Americans, but rather, the AHA’s pharmaceutical donors who will likely see a boost in sales.

5) Crohn’s & Colitis Foundation Inc.: $3,125,271

Mission: The Crohn’s & Colitis Foundation provides research, education, and support for patients with IBD (Crohn’s disease and ulcerative colitis).

Largest donations:

  • AbbVie—$2,735,395: AbbVie sells autoimmune disorder drug Humira.
  • Johnson & Johnson—$342,662: Sells autoimmune disorder drug Stelara.

6) AIDS United: $2,339,500

Mission: AIDS United seeks to “end the AIDS epidemic in the United States.”

Largest donations:

  • Bristol-Myers Squibb—$1,200,000: In 2015, Bristol-Myers Squibb’s HIV antiviral drug Reyataz made $1.14 billion in sales, and HIV antiviral drug Sustiva earned $1.25 billion. The company has since sold them both.
  • Johnson & Johnson—$881,500: Janssen, a Johnson & Johnson subsidiary, has an HIV preventative vaccine in clinical trials. They came under fire when they refused to participate in a United Nations patent pool whose mission is to reduce prices and increase access to HIV drugs worldwide.
  • Gilead—$250,000: Gilead is the leading manufacturer of HIV drugs worldwide, selling tenofovir disoproxil fumarate (TDF) antiretroviral drugs—Truvada, Viread, Atripla, Complera, and Stribild—and tenofovir alafenamide fumarate (TAF) drugs—Odefsey and Genvoya.

Gilead was the top corporate donor in the country in 2015, donating nearly $500 million just to patient access groups. These donations came right before a wave of bad press over the price hikes of their HIV TDF drugs. Critics claimed the price hikes were an attempt to get patients to switch to their new TAF drugs.

Our attorneys are now investigating allegations that the company withheld TAF, a drug that may not have the same risk of kidney and bone injuries as TDF, in order to maximize their profits.

Donations In Lieu of Lobbying?

These relationships are sometimes more than simply financial: 40% of patient advocacy groups have pharmaceutical executives on their boards who likely help shape group guidelines and policies.

If their relationships with the patient advocacy groups are strong enough, drug companies can leverage a large network of patients and families to help support clinical trials and development of new drugs. It’s no wonder why in 2015, pharmaceutical companies gave more in donations to patient advocacy groups than they spent on lobbying.

In 2015, pharmaceutical companies gave more in donations to patient advocacy groups than they spent on lobbying.

While these groups rely on donations to help and advocate for patients, relying on pharmaceutical companies for a significant part of their income can come at a price. Patient advocacy groups have been criticized in the past for not doing enough to speak out against drug pricing issues, like the skyrocketing price of epipens.

When patient advocacy groups do feel the need to speak out and testify to Congress or petition the FDA, these conflicts of interest are rarely disclosed. In fact, only 12% of these groups have policies for managing conflicts of interest. Some advocates believe that donations made to patient advocacy groups should meet disclosure requirements, similar to the Sunshine Act for physicians.

Until then, the public can consult websites like Pre$cription for Power and Pharmed Out, a website that lists patient advocacy groups that don’t accept donations from drug companies.

If you or a loved one were injured by a drug or medical device, learn about ongoing lawsuits against some of the largest pharmaceutical companies and drugs.

Dozens File Lawsuits Over Onglyza Heart Failure Risk

Patients who take Onglyza are 27% more likely to be hospitalized for heart failure.

Patients suffering from type 2 diabetes may have an increased risk of heart failure if they take the anti-diabetic medication Onglyza.

Onglyza (saxagliptin) is part of a class of drugs known as DPP-4 inhibitors which help the body retain incretin, a gut hormone that stimulates the pancreas to produce more insulin. But despite helping patients with type 2 diabetes maintain normal blood glucose levels, the drug’s risks may outweigh its benefits.

Studies show that patients who take Onglyza are 27% more likely to be hospitalized for heart failure compared to patients who take a placebo. Injured patients and their loved ones are now filing lawsuits against AstraZeneca, Onglyza’s manufacturer, and the company’s former partner Bristol-Myers Squibb.

Diabetics Already Have Greater Risk of Heart Disease

Adults with diabetes are two to four times more likely to die from heart disease than non-diabetics.

One of the most common diabetes complications is heart disease. According to the American Heart Association, 68% of people ages 65 and older with diabetes will die from heart disease. Overall, adults with diabetes are two to four times more likely to die from heart disease than non-diabetics.

Given these statistics, the FDA revised their anti-diabetic drug approval guidelines in 2008. Drug manufacturers are now required to prove the cardiovascular safety of their anti-diabetic drugs, and show that their medications will not result in an “unacceptable increase in cardiovascular risk.”

Onglyza was approved in 2009 after the change in FDA requirements. Yet, despite its FDA approval, a 2013 study would show that Onglyza presented a higher risk of hospitalization for heart failure—what some now claim is just the kind of unacceptable risk that the FDA was trying to prevent.

Onglyza Increases Risk of Hospitalization for Heart Failure

The “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus,” more commonly known as the SAVOR Trial, examined the long-term safety of Onglyza.

The trial followed more than 16,000 patients for roughly two years, all of whom had type 2 diabetes and a history or high risk for a cardiovascular event. Half of the group received Onglyza, and the other half a placebo.

SAVOR Trial researchers found that patients who received Onglyza were more likely to be hospitalized for heart failure: 3.5 percent of Onglyza patients were hospitalized for heart failure, compared to 2.8% of patients who were given a placebo. Overall, this presented a 27 percent increased risk of hospitalization for heart failure.

The results prompted an FDA investigation into Onglyza’s cardiovascular safety. In April 2016, 14 of the 15 members on the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted to approve a new saxagliptin safety warning. Labels on Onglyza and Kombiglyze XR (a saxagliptin and metformin combination drug also made by AstraZeneca) now warn that the drug may increase the risk of heart failure.

Nearly 100 Onglyza and Kombiglyze XR Lawsuits Filed 

In February 2018, 84 Onglyza and Kombiglyze cases were consolidated in a multidistrict litigation (MDL) in the U.S. District Court for Eastern District of Kentucky (IN RE: Onglyza and Kombiglyze XR Products Liability). As of March 14, 2018, the MDL swelled to include 94 cases.

Lawsuits allege that AstraZeneca and Bristol-Myers failed to perform adequate safety testing to determine if saxagliptin increased risks of cardiovascular injuries. They also claim that the companies failed to warn the FDA, medical community, and patients of saxagliptin’s increased risk of heart failure and death.

Did You Suffer from Heart Failure After Taking Onglyza?

If you or a loved one suffered from a severe cardiovascular injury like congestive heart failure or a heart attack after taking Onglyza or Kombiglyze XR, you may be eligible to file a lawsuit. A lawsuit may help recover compensation for medical bills, pain and suffering, loss of wages, and more.

Contact our attorneys for a free, no-obligation legal review. It never costs a thing unless we win a jury award or settlement for you.

Medical Journals Are Haunted by Pharma’s Ghostwriters

Readers are more likely to trust a paper written by a physician than one by a pharmaceutical company. Drug companies know this, which is why they engage in ghostwriting.

Universities kick students out for putting their names on papers they didn’t write. But, doctors are often financially rewarded for it.

Ghostwriting is when a writer writes a significant portion of a paper, or all of it, but isn’t credited. Instead, an academic or other notable figure’s name is recognized as the author. Sometimes the named author will edit the article before it’s published, but their contributions are often small.

Readers are more likely to trust a paper written by a well-respected physician than one by a pharmaceutical company. Drug companies know this, which is why they pay doctors for the right to list their names as authors on papers the company actually wrote.

Besides violating readers’ trust, swapping author names can have dangerous consequences in the medical field. Physicians rely on medical journals to help them make informed treatment decisions. Papers written by pharmaceutical companies are more likely to emphasize the benefits of their products, which may mislead doctors into thinking a drug or device is safer than it actually is.

Agencies Work ‘Hand-in-Glove’ With Drug Companies

Medical education and communication companies (MECCs) help drug companies write and publish content that shines a favorable light on their products. There are hundreds of these companies, which are mostly located near pharmaceutical companies in Pennsylvania, New Jersey, and the U.K.

“‘Key messages’ laid out by the drug companies are accommodated to the extent that they can be supported by available data.”

Pharmaceutical companies often hire MECCs to publish and place papers in peer-reviewed medical journals. Elliot Ross investigated the industry in an article for The Guardian.

“Having talked to over a dozen publication planners I found that the standard approach to article preparation is for planners to work hand-in-glove with drug companies to create a first draft,” he said. “‘Key messages’ laid out by the drug companies are accommodated to the extent that they can be supported by available data.”

Adelphi, a company that has promoted drugs like Neurontin, offers services like scientific narrative development, expert engagement, and scientific medical writing—services that sound an awful lot like ghostwriting.

Even Well-Respected Journals Have Ghostwriters

Publications like The Journal of the American Medical Association (JAMA), the Public Library of Science (PLoS), and The New England Journal of Medicine (NEJM) are respected for the quality of the research they print. Yet, even these publications are guilty of unknowingly publishing content written by ghostwriters.

In a survey of 622 medical research authors, nearly 8 percent said ghostwriters contributed to their articles. A separate study found that 8 percent of JAMA‘s articles had undisclosed ghostwriters, and 7.6 percent of PLoS content. More than one in 10 articles published in the NEJM were written with help from a ghostwriter.

When confronted with the high rates of ghostwriting in the NEJM, the highest among all of the journals, a spokesperson for the journal said she was “completely shocked.”

Half of Medical Literature Hides Dangerous Side Effects 

Nearly 75 percent of doctors change their treatment plans monthly or quarterly based on the medical literature they read. If this information isn’t accurate, it can have dangerous consequences. 

The reality though is that most published medical research has gaping holes. Even though adverse drug effects appear in 95% of medical research, only 46% of the literature discloses them. Physicians aren’t seeing the complete picture.  

In 2006, researcher Michael Steinman identified seven peer-reviewed articles for an anticonvulsant drug, Neurontin, that were written by MECCs: four of the articles had favorable conclusions, and the other three presented neutral conclusions. Parke Davis, a Pfizer-acquired company, reportedly paid academics $1,000 per paper for the right to use their names as the primary authors.

Internal documents released during litigation against drug companies shows similar practices across the industry. Ghostwritten articles about Prempro, a drug that treats menopause, downplayed its breast cancer risk, and articles about Paxil, an antidepressant, downplayed the increased risk of suicidal thoughts among children.

Merck Publishing Machine Spins Vioxx Safety Data

One of the most dangerous pharmaceutical ghostwriting strategies came from Merck, who tried to use content to boost sales of their arthritis drug Vioxx (rofecoxib).

Internal documents produced between 1996 and 2004 included contracts with medical publishing companies for ghostwritten articles, and exchanges with the academics who were listed as the authors of those articles.

Only 72 of the Vioxx articles ghostwritten by Merck disclosed Merck’s sponsorship or financial ties to the author.

One of the released internal documents was a flow-chart created by Eric Crown, Merck’s publications manager, that outlined each step of the editorial process. After Merck’s employees finished writing the articles, including discussing clinical study findings, and selecting where the article would be published, only then did they determine whose name would be used as the author. Academics received between $750 and $2500 to have their names listed as authors.

A JAMA study found that among 72 Vioxx articles ghostwritten by Merck, only half of them disclosed Merck’s sponsorship or financial ties to the author.

After just five years on the market, Merck voluntarily withdrew Vioxx in 2004. Research showed that Vioxx doubled the risk of heart attack and stroke in patients who took the medication for more than 18 months.

Not surprisingly, the peer-reviewed articles Merck wrote downplayed Vioxx’s risks. They only reported 17 of the 20 heart attacks experienced by their VIGOR trial participants in an article for the NEJM

(Click below for more.)

STAT News Officially Has a Credibility Problem

STAT News is the latest independent publication to be haunted by pharmaceutical ghostwriting and authors with undisclosed industry ties.  

Big Pharma’s influence can be found everywhere. There are the in-your-face drug advertisements, like the ones you see on television. Then there are the crafty PR pieces that are so subtle, only the most trained eyes can spot them for what they are: ploys to get doctors to prescribe the next big drug, and marketing pitches to get patients to ask for them.

Ghostwriters and Pharma-backed writers fall into this latter category. These authors try to come off as just another concerned doctor, patient, or advocate, but in reality their opinions are heavily influenced by their relationships with pharmaceutical companies.

In the last year alone, Forbes, USA Today, Newsweek, and the Los Angeles Times have published opinion pieces by authors with known conflicts of interest. Some of these articles have since been retracted once the editors realized their editorial policies were violated, but many still stand in their original forms.

STAT News, an independent medical publication associated with The Boston Globe, is the latest publication to be haunted by pharmaceutical ghostwriting and undisclosed industry ties.  

Patient Praises Drug Ads with Help from Gilead Sciences

The company’s PR firm asked Ms. Dushane to write an op-ed for STAT, then helped her edit the piece.

STAT launched in 2015 with the noble mission to use writing to “hold individuals and institutions accountable.” But despite its good intentions, authors backed by for-profit companies have slipped their way into the publication’s opinion section multiple times.

In 2016, STAT ran an op-ed titled “You can complain about TV drug ads. They may have saved my life,” written by Deborah Clark Dushane. The retired educator praised drug commercials for leading her to a medicine that cured her chronic hepatitis C.

Ms. Dushane writes, “I strongly believe that if I hadn’t seen TV ads about chronic hepatitis C and new drugs to treat it, I wouldn’t have done anything to protect myself against it.”

Ms. Dushane doesn’t name the “new drug” she discovered. But the op-ed was published just a few weeks after a STAT article criticizing an advertisement campaign for a new hepatitis C drug called Harvoni, made by Gilead Sciences. Harvoni had one of the most expensive drug ad campaigns that year coming in at $100 million.

HealthNewsReview, a media watchdog group, discovered that the op-ed originated from a letter Ms. Dushane wrote to Gilead Sciences: the same company that manufactures Harvoni.

The company’s PR firm asked her to write an op-ed for STAT, then helped her edit the piece. It’s unclear if Gilead Sciences paid her, but they did fly her out to California to learn more about their company and products.

In September 2017, STAT updated the article to disclose Ms. Dushane’s relationship with Gilead Sciences.

Physician Fails to Disclose Millions in Vaccine Profits

As the rotavirus vaccine inventor, Dr. Offit was entitled to 30% of the profits, or roughly $45 million.

Like patients, sometimes doctors have ties to corporations that may affect their position on the use of pharmaceutical drugs or vaccines. This is the case for Dr. Paul Offit, an outspoken vaccine defender who rarely addresses his financial relationship with Merck.

Dr. Offit currently holds a research chair at the Children’s Hospital of Philadelphia that is funded by Merck. He also helped to develop a rotavirus vaccine that reportedly earned the Children’s Hospital of Philadelphia more than $150 million when Merck bought the vaccine patent. As the vaccine inventor, Dr. Offit was entitled to 30 percent of the profits, or roughly $45 million.

Needless to say, Dr. Offit isn’t the most objective scientist to comment on vaccine safety. Yet, STAT published his response to an interview with Robert F. Kennedy, Jr. on the White House vaccine safety commission without disclosing his vaccine profits.

At Kennedy’s request, his conversation with STAT was published in a Q&A format to avoid being misquoted and misrepresented.

The two briefly discussed vaccine safety before Branswell tried to switch back to the White House commission that Kennedy was asked to chair, though he already made it clear that his knowledge was limited. STAT Senior Writer Helen Branswell stated, “So I had some questions I wanted to ask you, and in a Q&A that’s the way it works. I ask some questions, you answer the questions or don’t answer if you like.”

The interview was more combative and one-sided than what you would expect from an independent medical publication. But Dr. Offit still felt that a “cigarette-style caution” should be printed above the interview. It’s a bold statement from someone who didn’t disclose their financial ties with one of the largest vaccine manufacturers. 

STAT Publishes Op-ed By Corporate-Funded Group

Publishing articles by individuals with ties to corporations is one thing; publishing articles by known industry front groups is another.

In 2017, STAT News published an article written by two members of the American Council on Science & Health (ACSH), an industry front group with ties to Big Tobacco, Big Agriculture, and Big Pharma. ACSH was created to oppose the “junk science” they believed environmental groups like the National Resources Defense Council promoted, and the chemophobia (or aversion to chemicals) found in mainstream media. (Interestingly, Dr. Offit served on the ACSH Board.)

The ACSH op-ed, written by Josh Bloom and Alex Berezow, argues for more lenient opioid prescription policies. They recommend scrapping the policies written by the Centers for Disease Control and Prevention (CDC) intended to curb the opioid crisis, and replacing them with “rules that do not punish patients with legitimate needs for opioids or the doctors who are trying to help them.”

Berezow, ACSH’s Senior Fellow of Biomedical Science, also writes for USA Today.

In his USA Today articles, Berezow has argued that Scott Gottlieb’s industry ties will only make him a better FDA leader, and that there is no evidence to support the link between talc and ovarian cancer. An analysis of 16 studies shows that talcum powder is associated with a 33 percent increased risk for ovarian cancer.

These articles echo the pro-industry content found on the ACSH website. Blog posts range from “BPA is Just as Dangerous as it Never Was” to “Should Medical Textbook Authors Have to Disclose Industry Payments?” That last article, by the way, argued that industry payments don’t automatically delegitimize work, and suggests that if readers dismiss authors they feel are biased, then they may be just as biased themselves.

According to ACSH’s internal documents, they have received donations from corporations like Chevron, Bristol Myers Squibb Foundation, Bayer Cropscience, and 3M, to name just a few. From July through December 2012, 58 percent of ACSH donations came from corporations and large private foundations.

Neither STAT nor USA Today acknowledged these conflicts of interest, and the articles remain in their original forms.

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Purdue Stops Pushing OxyContin to Doctors Amid Lawsuits

As of February 11, Purdue Pharma has stopped selling OxyContin, the world’s top-selling opioid, directly to doctors.

In 2016, there were 215 million opioid prescriptions in the U.S. alone, a scary statistic considering that more than 100 people die every day in the U.S. from opioid overdoses.

Overprescription is a major contributor to the opioid epidemic. Pharmaceutical companies helped create the problem by overpromising the benefits and downplaying the risks of opioids for years, misleading healthcare professionals about their safety.

U.S. states and local communities are now filing lawsuits against opioid manufacturers and distributors for their roles in the crisis. Facing litigation pressure, some pharmaceutical companies are sponsoring dependency prevention programs and reforming how the highly addictive pain killers are distributed and marketed.

In a major move, Purdue Pharma announced that starting February 11 they would stop selling OxyContin, the world’s top-selling opioid, directly to doctors. The company announced in a statement that they will cut their sales team in half, leaving them with about 200 sales representatives. The Purdue sales team will instead focus their efforts on Symproic, a drug that treats opioid-induced constipation.

Purdue Spent Millions Selling OxyContin to Prescribers

From 2013 to 2015, healthcare professionals received $46 million from opioid manufacturers.

Since OxyContin’s 1996 approval, Purdue has aggressively marketed the drug to prescribers. For years, they falsely claimed OxyContin was less addictive than fast-acting opioids like Vicodin because it was designed to work in 12-hour increments.

In 2007, the Department of Justice charged Purdue with false branding. The company and three executives, including the president, pled guilty and agreed to a $634.5 million settlement.

Purdue spent millions of dollars misleading healthcare professionals to ensure OxyContin became one of the most prescribed painkillers. From August 2013 to December 2015, Purdue spent $2.9 million marketing OxyContin directly to doctors.

From 2013 to 2015, healthcare professionals received $46 million from opioid manufacturers. Companies spent more time and money marketing opioids than they did on less addictive painkillers. 

Purdue’s Marketing Tactics “Changed Paradigm for Opioid Use”

One in 12 doctors received money from a drug company marketing opioids.

A study published in the American Journal of Public Health found that one in 12 doctors received money from a drug company marketing opioids. Speaking fees were responsible for two-thirds of that amount. Prescriber payments also go towards consulting fees, travel expenses, free meals, and other perks.

The same study found that doctors who received industry payments were two to three times more likely to prescribe brand name drugs at high levels than doctors who did not receive payments.

To stem the influence of pharmaceutical sales representatives, Chicago announced in 2016 that they would be required to obtain a license. Licensed sales representatives are required to undergo training on ethics, marketing regulations, and related laws. Licensure also requires sales professionals to disclose which doctors they speak to and how many times they visit them, as well as any gifts or other materials given to healthcare professionals.

In an interview with PBS Newshour, Lev Facher said that Purdue’s decision to stop marketing OxyContin to doctors is a major change for the industry.

“This is the company that really changed the paradigm for opioid use in the 1990’s by aggressively marketing it to prescribers,” said Flecher. “The fact that Purdue has decided it’s no longer going to go into doctors’ offices and push this drug is really symbolic of where the country currently is in terms of considering the opioid epidemic a public health crisis and in terms of recognizing the potential harmful characteristics of drugs like OxyContin.”

Hundreds of Lawsuits Pressure Opioid Industry to Reform

Opioid manufacturers and distributors face hundreds of lawsuits from cities and states alleging that their marketing practices helped create the crisis.

The opioid crisis has disproportionally affected rural America. Morgan & Morgan’s Government Action Group is representing the state of Kentucky and local governments in West Virginia in lawsuits against opioid manufacturers, distributors, and other players who may have helped to create or exacerbate the drug crisis. Defendants include opioid distributors McKesson and Cardinal Health.

Purdue alone faces lawsuits from more than 400 cities and 14 states alleging that they falsely marketed OxyContin and misrepresented its risks. 

In addition to litigation, yearly sales for OxyContin have also been declining. Since 2012, prescriptions have fallen 17%, and starting this year, insurer Cigna no longer covers OxyContin as part of their attempt to cut patient opioid use 25% by 2019.

These lawsuits and financial hits likely contributed to Purdue’s decision to abandon prescriber marketing.

Pharma is Now Trying to Solve the Problem it Helped Create

Purdue isn’t the only company who is backpedaling to trying to alleviate the opioid crisis. 

McKesson’s Allied Against Opioid Abuse program delivered 300,000 drug deactivation pouches to pharmacies in Pennsylvania, which are used to safely dispose of unused opioids.

Through their Opioid Action Program, Cardinal Health provides Narcan, an opiate antidote, free of charge to the Kentucky State Police and community programs in West Virginia, like Great Rivers Harm Reduction Coalition. This is a major cost savings as a Narcan kit with just one to two doses can cost somewhere between $130 and $140. The program also sponsors anonymous opioid drop-off events.

“These are the most progressive efforts our group has seen by any of the defendants to curb this crisis.”

Cardinal also supports opioid dependency prevention education through a partnership with Ohio State University College of Pharmacy. Their GenerationRx offers free education materials on the risks of pharmaceutical drug abuse for multiple groups, including students and patients.

“These are the most progressive efforts our group has seen by any of the defendants to curb this crisis,” said Attorney Sarah Foster, who is part of Morgan and Morgan’s Government Action Group representing Kentucky and local governments in West Virginia against opioid manufacturers and distributors.

“Perhaps most importantly, there are admissions in the materials provided by GenerationRx of the down sides of prescription medications in less technical language than that included in black box warnings used by the manufacturers. We hope for our clients that this consumer-focused approach will be effective,” Attorney Foster said.

The opioid crisis cannot turn a corner without the help from pharmaceutical companies. While these education programs and marketing and distribution reforms may have only happened because of weak sales and litigation pressure, they are happening nonetheless. 

This Is How Opioid Lawsuits Differ from Big Tobacco’s

If 2017 was the year the opioid crisis was recognized as a public health emergency, then 2018 may be the year we begin producing solutions to the crisis.

To that end, opioid litigation—which combines more than 200 government lawsuits against dozens of companies and individuals—is one of the most promising developments.

The judge overseeing the federal opioid lawsuit said on January 9 that he hopes a sweeping resolution with a “meaningful impact” can be worked out by the end of the year.

Opioid litigation and tobacco litigation share many similarities, but there are also significant differences.

“We have to dramatically reduce the total number of pills out there, and make sure the pills that are out there are being used properly,” said U.S. District Judge Dan Polster of Ohio in his Cleveland courtroom. The judge likened the opioid crisis to the 1918 flu epidemic that killed hundreds of thousands of Americans while making the important distinction that this epidemic is “100 percent man-made.”

Litigation to combat a public health problem is not without precedent. Hopes are high that opioid litigation will produce a settlement on par with the Big Tobacco settlement of 1998, which saw tobacco companies pay billions of dollars to states to cover the costs of smoking.

ClassAction.com attorneys like Keith Mitnik helped lead the fight against tobacco companies, and they are playing a prominent role in opioid lawsuits. Opioid litigation and tobacco litigation share many similarities, but there are also significant differences.

Now we will explain the current wave of litigation, compare it to tobacco cases, and explain how governments might use settlement money to fight the opioid crisis.

Governments Sue to Recover Costs of Opioid Harms

Kentucky’s Attorney General, Andy Beshear, filed a lawsuit against Endo Pharmaceuticals (maker of opioid drug Opana ER) on November 6, 2017 to “hold Endo responsible for unlawfully building a market for the chronic use of opioids in the name of increasing corporate profits, knowing all along the dangers of Opana ER that led to devastating effects on the Commonwealth.”

Hundreds of local governments are suing the opioid industry to recover costs related to the crisis.

Beshear, with help from ClassAction.com attorneys like James Young, seeks compensation on behalf of the Commonwealth for increased costs to the state. These include costs from emergency room visits, emergency responses to overdoses, the administration of anti-overdose drug Naloxene, Hepatitis C from intravenous opioid use, drug-related crimes, and other harms. Kentucky claims these damages are the result of Endo’s allegedly deceptive, aggressive, and illegal opioid marketing.

“This action seeks repayment of the Commonwealth’s spending on opioids, disgorgement of Endo’s unjust profits, civil penalties for its egregious violations of law, compensatory and punitive damages, injunctive relief, and abatement of the public nuisance Endo has helped create,” states the lawsuit.

The Commonwealth of Kentucky is joined in its legal battle by many Kentucky cities and counties that similarly seek to recoup the costs of the health crisis that has devastated their communities.

Nationwide, hundreds of states, cities, counties, and even Native American tribes are suing the opioid industry for addiction costs for which they say the opioid industry is responsible. Some, like the Kentucky AG’s suit, name a single defendant. Others name a dozen, from manufacturers and distributors to doctors and clinics.

These lawsuits have been consolidated in Ohio federal court as part of multidistrict litigation (MDL) before Judge Polster. According to an order establishing the MDL, the opioid lawsuits consolidated in the Northern District of Ohio contain “common questions of fact,” including:

  • Prescription opioid manufacturers overstated the benefits and downplayed the risks of using opioids and aggressively marketed the drugs.
  • Distributors failed to monitor, detect, investigate, and report suspicious orders of prescription opioid painkillers.

Since opioid manufacturers and distributors are the primary defendants named in lawsuits, their alleged roles in the opioid crisis deserve a closer look.

Claims Against Opioid Manufacturers

Purdue Pharma, Teva Pharmaceuticals, Johnson & Johnson, Janssen Pharmaceuticals, Endo Health Solutions, Allergan PLC, and Actavis, Inc. are among the drug companies named as defendants in opioid litigation.

The allegations made against drug companies are virtually identical. A State of Ohio lawsuit, for example, makes the typical assertions that manufacturers

  • Engaged in a deceptive marketing scheme designed to change opioid prescribing patterns (from end-of-life care only to “chronic pain”). This greatly broadened the pool of patients to whom opioids could be prescribed and led to a huge increase in profits for opioid manufacturers.
  • Downplayed the addiction risks and overstated the benefits of opioid painkillers.
  • Worked through third parties—including front groups and key opinion leaders—to disseminate their misleading messages about opioids.
  • Placed their desire for profits above the health and well-being of their customers and the communities where they live, and in so doing unleashed a public healthcare crisis with extensive financial and social consequences.
  • Caused substantial economic injury to state, city, and county agencies.

The Ohio lawsuit seeks damages from drug manufacturer defendants to pay for opioid-related costs such as increased spending by the state’s Medicaid department, workers’ compensation bureau, drug treatment and counseling services, child protection agencies (due to parental drug addiction), emergency medical services, and law enforcement responding to a surge in drug abuse and crime.

Claims Against Drug Distributors

Drug manufacturers are not permitted to sell their products directly to pharmacies. They must use a distributor (wholesale) company that serves as an intermediary between manufacturer and pharmacy.

Lawsuits claim that distributors helped fuel the opioid crisis because they failed to properly monitor drug shipments.

The major distributors of opioid painkillers are AmerisourceBergen, Cardinal Health, and McKesson Corporation. Because drugs like oxycodone and hydrocodone are controlled substances, licensing regulations impose duties on distributors to provide effective controls and procedures to prevent theft and diversion of opioids.

Lawsuits, including a case filed by New Mexico, claim that these distributors played a crucial role in perpetuating the opioid crisis because they violated these duties and allowed opioid diversion to flourish.

New Mexico accuses drug distributors of the following:

  • Selling huge quantities of prescription opioids that were diverted from lawful medical purposes
  • Breaching their legal duties to prevent diversion
  • Failing to report suspicious opioid orders (orders of unusual size, orders of unusual frequency, and orders deviating substantially from a normal pattern)
  • Failing to monitor, detect, halt, investigate, and refuse suspicious orders
  • Misleading the public about complying with their obligations to meet licensing regulations
  • Causing substantial economic damages to state and local governments due to their breaches of legal duties

The New Mexico lawsuit seeks economic damages from drug distributor defendants as reimbursement for the costs associated with past—and ongoing—efforts to eliminate the hazards of opioid proliferation to public health and safety, including from prescription opioid and heroin abuse, addiction, morbidity, and mortality.

It names manufacturers and distributors as defendants and calls for a “multifaceted, collaborative public health and law enforcement approach” focused on preventing new cases of addiction and ensuring access to addiction treatment. The complaint notes “budgetary constraints at the state and Federal levels” that limit solutions.

“Having profited enormously through the aggressive sale, misleading promotion, and irresponsible distribution of opiates,” says New Mexico, “Defendants should be required to take responsibility for the financial burdens their conduct has inflicted.”

Comparing Opioid Litigation and Tobacco Litigation

In November 1998, the Attorneys General of 46 states, five U.S. territories, and the District of Columbia reached a $246 billion settlement with the five largest American tobacco companies. Tobacco companies agreed to divert revenues to states over the ensuing 25 years and to impose restrictions on the sale and marketing of cigarettes.

The landmark settlement was borne of an ingenious legal strategy. Dying smokers and their families filed hundreds of lawsuits against tobacco companies, but juries always found that smokers were responsible for smoking.

Tobacco companies reached a $246 billion settlement with 46 states, five territories, and the District of Columbia.

To deny the tobacco industry its traditional defense, state attorneys decided to sue companies to recoup the costs to Medicaid programs of treating smoking-related ailments (such as heart disease), since treatments left many smokers penniless and these programs had to bear the remaining costs. The state attorneys hired outside counsel on a contingency-fee basis to bring cases on behalf of governments.

With opioid lawsuits gaining momentum, some observers have suggested that litigation against the opioid industry is the second coming of tobacco litigation. On its face, this comparison is accurate: governments are hiring firms on a contingency-fee basis to sue private companies and recoup the costs of a public health problem caused by an addictive drug whose dangers companies allegedly concealed.

A more careful analysis, however, reveals many key differences between tobacco and opioid litigation.

Cities and counties are involved in opioid litigation

Tobacco lawsuits were brought on behalf of states to recoup Medicaid payments tied to smoking. States have filed opioid lawsuits, but cities and counties—which have dealt with the costs of opioid addiction on a non-Medicaid basis—are also a part of the litigation.

“An important distinction between this litigation and tobacco is that the local municipalities are serious players in seeking to recoup their expenses and to get help paying for the solutions in their community,” said ClassAction.com attorney James Young.

The different types of plaintiffs and alleged harms makes opioid litigation much more complicated than tobacco’s. It could make it more difficult for plaintiffs to cooperate and agree on a mutually satisfactory settlement.

“This could prove interesting when it comes time to settle, since each community will have unique needs and plans,” said James Young. “In tobacco, the plaintiffs were the state attorneys general, which were more cohesive in what they sought.”

Opioid litigation names numerous defendants

Tobacco litigation focused on just a handful of companies that manufactured their own products and sold them directly to consumers. In the case of opioids, there are opioid manufacturers, the companies that distribute opioids, the clinics that sell them, and the doctors that prescribe them. This adds another layer of complexity to the litigation that wasn’t found in tobacco cases.

Tobacco and opioid painkillers are very different products

A major difference between tobacco and opioids is that the former has no legitimate medical uses. Opioids, however, are an important pain medication for many patients. Some patients who say they need opioids and have used them for years without problems complain that they are now unable to get the drugs due to crackdowns. Reforms resulting from a settlement might only exacerbate this problem.

Another major issue is that, unlike tobacco, opioid painkillers were approved by the U.S. Food and Drug Administration (FDA) and included certain regulations and warnings. This could allow defendants to “shift some of the blame to the federal government,” as NPR’s Ailsa Chang suggested.

The tobacco industry is wealthier

Even if a settlement is reached in opioid litigation, the plaintiffs probably shouldn’t expect a payout rivaling the one from Big Tobacco, an industry that, despite the hits it has taken over the last couple of decades, is still enormously profitable.

The U.S. opioid market generates around $10 billion in annual gross sales. Big Tobacco had nearly $20 billion in net profits in 2016. For comparison, OxyContin maker Purdue Pharma has about $3 billion in annual revenue. That’s certainly no pittance, but it raises the question of whether enough money can be collected from the opioid industry to help solve the problems it allegedly fostered.

There were tobacco industry whistleblowers

Plaintiffs had a secret weapon in tobacco litigation: whistleblowers who produced internal documents from tobacco companies showing that they hid evidence of the risks and addictiveness of smoking.

It’s possible that whistleblowers from drug companies will play a similar role in opioid litigation, but so far, none have come forward with damning evidence (although an ex-DEA whistleblower has some pointed things to say about the drug industry and Congress).

It All Depends on How the Money is Spent

One of the biggest lessons learned from tobacco litigation is that it isn’t how much money plaintiffs receive—it’s how they spend that money.

Data on state spending of money from the Tobacco Master Settlement Agreement shows wide variability in how states spent money that was supposed to be used fund Medicaid services and anti-smoking education programs. The money often went elsewhere.

“If you’re going to get the money… don’t let it be used by whatever the legislature wants.”

For example, as of 2010 California had received $401,637,000 from tobacco companies—and spent every cent on debt servicing/budget shortfalls.

Jim Tierney, former Attorney General of Maine, told NPR that “if you’re going to get the money, don’t make the mistake in tobacco and let it be used by whatever the legislature wants. They’ll use it to pave roads… or lower taxes or something preposterous when we have a huge health crisis.”

What Happens Next

In the event that plaintiffs and defendants cannot reach a settlement in the opioid MDL, individual lawsuits would be returned to their local jurisdictions and tried by those courts. But the unknowns of a jury trial could convince both sides that a settlement is the more prudent option.

Opioid defendants may want to avoid facing juries from opioid-ravaged communities, as those who decide their legal fate could very well have lost loved ones to the crisis. At the moment, though, they appear to hold a crucial edge in public opinion.

A 2017 poll found that respondents primarily blamed patients and doctors for the nation’s opioid crisis. Fifteen percent said that drug companies were most responsible, while seven percent primarily blamed drug distributors.

Companies are keenly aware of public opinion and how it impacts their bottom line. Deep public mistrust of tobacco companies was a crucial factor in the decision of company officials to settle. They knew that facing juries could be more costly than settling, that it might even lead to bankruptcy.

As lawsuits proceed, however, evidence may emerge that reveals harmful, unethical, and illegal business practices that turn public opinion against opioid companies.

At the same time, plaintiffs have no guarantees that a trial will produce favorable results—that is, if they even get that far. While there is a precedent of opioid manufacturers and distributors settling state lawsuits involving similar allegations for hundreds of millions of dollars, the companies admitted no fault. Still, they produced funds that governments desperately needed to deal with the opioid crisis and resulted in changes to industry practices.

Opioid plaintiffs and defendants in the current MDL have already begun settlement discussions. How they end is anyone’s guess, but win or lose, lawsuits against the opioid industry show that communities are serious about solving the worst drug crisis in America’s history.

James Young Joins Opioid Plaintiffs’ Executive Committee

Earlier this week, U.S. District Judge Dan Polster appointed Morgan & Morgan attorney James Young to the Plaintiffs’ Executive Committee (PEC) in the massive multi-district litigation spawned by the opioid crisis.

Cities, counties and states across the country have filed lawsuits against opioid manufacturers and distributors for their role in the crisis. These lawsuits claim that doctors, drug companies, and “pill mills” exploited patients, downplayed the addictive nature of opioids, and cost local governments millions of dollars.

Read the Order

They also allege that wholesale drug distributors such as McKesson, Cardinal Health, and AmerisourceBergen failed to monitor and report suspiciously large opioid orders.

“I am beyond proud to be counted among the extraordinary attorneys chosen to oversee the most important litigation in my lifetime.”

Young has filed opioid lawsuits on behalf of 17 such governments in West Virginia, one of the most affected areas in the country.

“I am beyond proud to be counted among the extraordinary attorneys chosen to oversee what I believe to be the most important litigation in my lifetime,” Young said.

Committee Will Oversee Hundreds of Lawsuits

The consolidated opioid cases—which involve multiple lawsuits and law firms—require a unique leadership structure to ensure effective management of the multi-district litigation. This leadership often takes the form of a plaintiffs’ executive committee and/or a plaintiffs’ steering committee. (The steering committee in the opioids MDL has yet to be determined.)

Committee members perform numerous crucial functions like working with lead counsel on case strategy, developing a litigation plan, managing discovery, preparing legal briefs, and presenting arguments to the court. In the opioids MDL, the plaintiffs’ executive committee is comprised of 16 members who (along with six co-lead counsels) will oversee more than 180 lawsuits.

That number of lawsuits is expected to grow significantly in coming months, as more and more municipalities seek justice for their ravaged communities.

Young Calls Appointment “A Dream Come True”

National Law Journal writer Amanda Bronstad described the committee, including Young, as a “’Who’s Who’ in mass torts.”

Young is nationally known in the areas of consumer protection, health fraud, and pharmaceutical litigation. He is the former Special Counsel to the Florida Attorney General, where he focused on litigating pharmaceutical fraud claims. He has also served in leadership positions in several multi-state Attorney General investigations, including starting and co-leading the largest consumer protection drug settlement to date, In Re Risperdal.

The committee has been called a “‘Who’s Who’ in mass torts.”

Even with all those milestones, Young called his appointment to the opioid litigation’s PEC “a career achievement and a dream come true.”

Morgan & Morgan has filed opioid lawsuits on behalf of the Commonwealth of Kentucky and the following local governments in West Virginia (the latter cases are part of the MDL, the former is not):

  • Town of Addison (formerly the city of Webster Springs)
  • Barbour County
  • Town of Chapmanville
  • Clay County
  • Town of Gilbert
  • Town of Hamlin
  • Town of Kermit
  • Lincoln County
  • Mason County
  • McDowell County
  • Mercer County
  • Mingo County
  • Taylor County
  • Webster County
  • City of Welch
  • Town of West Hamlin
  • City of Williamson

Now James Young will use his expertise to help shape hundreds of similar opioid cases across America.

One-Third of Medical Errors Caused by Poor Labeling

Labeling and packaging issues are the leading cause of medication errors.

If you’ve ever thought that the instructions and warnings that come with your medications and medical devices required a medical degree to understand, you aren’t alone.

In fact, an Institute of Medicine study found that labeling and packaging issues (particularly confusing instructions) were the leading cause of medication errors (33%) and deaths from medication errors (30%). Medical devices trend the same way. The FDA’s Center for Devices and Radiological Health reports that one-third of the roughly 100,000 medical device event reports they receive each year are attributed to use error.

Part of the problem is that there is a lack of consistency across labeling. While manufacturers are required to include important warnings and dosage information in their packaging, the format and symbols can vary between products. And, if a physician can’t find information on a label quickly, or if a patient can’t understand how to use their medical device or drug at home, it can result in serious complications.

Only 15% of Pharmaceutical Drugs Follow FDA Standards

The FDA realizes the medical industry is suffering from weak labeling regulations, but fixing the problem has proven to be a decade-long process.

Currently, there is no standard for medical device labeling or instructions. While manufacturers are required to include certain information in those materials, there is no format for them to follow, nor is there a set of common terminology to use.

In 2006, the FDA addressed this problem with pharmaceutical drugs. The Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, or the Physician Labeling Rule, established standards for everything from what information should be highlighted, to what size font should be used and what should be bolded.

Though the standards have existed for more than 10 years, only 15% of pharmaceutical drugs follow the labeling rule.

Confusing Labeling Can Result in Drug Overdosing

Every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error.

In 2006, drug officials stated that the U.S. spent $4 to $4.8 billion on medical errors that could be prevented if drug manufacturers improved the information they provided to doctors.

But this isn’t just a financial problem; it’s a public health issue.

A 2017 study reported that every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error. Medication misuse, they found, has increased 100% since 2000.

Henry Spiller, one of the study’s authors and the director of the Central Ohio Poison Center, emphasized the role that drug manufacturers and pharmacists play in reducing medication errors.

“There is room for improvement in product packaging and labeling,” he said in a statement. “Dosing instructions could be made clearer, especially for patients and caregivers with limited literacy or numeracy.”

Labeling confusion recently resulted in a number of patients overdosing on the antibiotic Zerbaxa. The FDA warned that Zerbaxa’s vial and carton listed the strength of each ingredient, rather than the strength of the dose. This caused some patients to receive 50% stronger doses than they should have.

Hernia Mesh Manufacturers Accused of “Extreme Underreporting”  

Medical device manufacturers are just as guilty of providing weak labeling and instructions.

In a recent study published in the Journal of the American College of Surgeons, researchers found that the majority of hernia mesh labels were missing important information:

  • 67% of hernia mesh labels did not provide information on the device composition.
  • 69% of hernia mesh instructions did not provide information on the device mechanics.
  • 89% of hernia mesh instructions did not provide information on the device thickness.

There is an extreme underreporting and lack of consistency of clinically important mesh properties,” concluded researchers. More standardized information and terminology, they claimed, would improve physician decision making during hernia repair.

The complete lack of information available to physicians is astounding given how common hernia mesh injuries are. Thousands of lawsuits that have been filed against manufacturers alleging that the mesh migrated and stretched in their bodies, causing internal injuries and ultimately requiring revision surgery.

In 2011, C.R. Bard offered to pay $184 million to settle 2,600 lawsuits for its Composix Kugel Mesh. And Ethicon—whose Physiomesh was recalled in July of 2016 for its high complications risk—faces its first trial in January 2018.

Medical Device Manufacturers Fight Labeling Database for Patients

As part of their effort to reduce confusion and medical device use error, the FDA is piloting an electronic database for medical device labeling. Because medical devices are typically used for years, patients often discard or misplace the original packaging and instructions, and may not know if the manufacturer has issued new warnings. 

Since 2007, the FDA has required medical device manufacturers to submit their device registration information electronically, but not the labeling. Currently, there is no easy way for patients to find the original labeling and instructions for their medical devices.

Astoundingly, manufacturers claimed that a database for medical device instructions would actually negatively affect patient safety.

But not everyone is eager to improve communication with patients. AdvaMed, the trade association for medical device manufacturers, went so far as to claim that a database for medical device instructions would actually negatively affect patient safety.

“An online medical device repository would pose numerous problems, including risk to patient safety due to the number of medical devices and the frequency of which patient labeling may be updated,” AdvaMed claimed.

Their reasons? Because if people go online, they may not pick up the phone to call customer service.

“An online repository for all medical devices may divert users from human interaction with Customer Service personnel trained in the operation and maintenance of their devices,” they stated.

It’s an extremely weak attempt to fight regulations which will enable patients to easily find vital safety information.

This isn’t the first time that manufacturers have resisted recommendations to improve patient safety, nor will it be the last. If you or a loved one were injured by a medical device or medication, contact us for a free, no-obligation legal review.

Invokana Lawsuits Mount after Black Box Warning

As more studies solidify the link between Invokana (or canagliflozin) and diabetic ketoacidosis (DKA), more patients are filing lawsuits alleging that drugmaker Janssen failed to warn adequately about these side effects. Hundreds such lawsuits comprise the Invokana multi-district litigation (MDL) in New Jersey.

These cases received a boost earlier this year when the U.S. Food and Drug Administration (FDA) added a black box warning highlighting Invokana’s heightened risks of foot and leg amputations.

Amputation Risk May Be Twice as High

“Some patients had more than one amputation, some involving both limbs.”

The FDA required that warning after two different clinical trials, CANVAS and CANVAS-R, “showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo.”

Each trial took place over the course of a year. The CANVAS study found:

  • Out of every 1,000 patients taking placebos, 2.8 required amputations
  • Out of every 1,000 patients taking canagliflozin, 5.9 (more than twice as many) required amputations

While the CANVAS-R study was not quite as grim, it also found an elevated amputation risk for patients taking Invokana:

  • Out of every 1,000 patients taking placebos, 4.2 required amputations
  • Out of every 1,000 patients taking canagliflozin, 7.5 required amputations (a 79 percent increase)

The most common amputations were of the foot or toe. Alarmingly, the FDA also notes, “Some patients had more than one amputation, some involving both limbs.”

Sales Dip in Light of Frightening Studies

Another study, which appeared in The Lancet Diabetes & Endocrinology, also proved worrisome for Invokana users.

That study, which appeared in August 2017, found that of the 66 SGLT2 inhibitor-related amputations, “Most of the available reports (57 [86%] of 66) listed canagliflozin as a suspect or concomitant drug.”

In the first quarter of 2017, Invokana sales dropped by 10 percent.

The FAERS assessment finds that the rate of amputation among patients on canagliflozin is “significantly higher” than others, and concludes, “…use of canagliflozin, but not dapagliflozin or empagliflozin, might be associated with an increased risk of amputations.”

Not surprisingly, the CANVAS and FAERS analyses compelled some doctors to take their patients off Invokana. Dr. Steve Nissan told MedPage Today that he is “uncomfortable prescribing [canagliflozin] in view of the amputation risk.”

From 2014 to 2015 Invokana sales more than doubled, from $586 million to $1.31 billion. But from 2015 to 2016 sales barely increased, and in the first quarter of 2017 they dropped by 10 percent.

With a new black box warning, scientists sounding the alarm, and alternative drugs emerging, Invokana is likely past its prime in terms of prescriptions and sales. But what about all the patients who have already taken it and suffered life-altering side effects?

Invokana Bellwether Trials Set for Fall 2018

Hundreds of Invokana patients have filed lawsuits against Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson). They allege that Janssen misrepresented the drug’s risks and failed to warn patients about side effects like lower extremity amputations.

The recent $28 million Xarelto verdict could compel J&J to settle.

Bellwether trials are not scheduled to begin until September 2018, but major losses like the recent $28 million Xarelto verdict could compel J&J to settle these cases before they make it to court.

How Big Pharma Wrings More Profits from Opioid Addicts

Every crisis provides an opportunity, as the saying goes.

Big Pharma, always angling for the next blockbuster drug, is making the most of the opioid crisis. The industry is introducing new drugs—and raising the price on older generics—that treat the effects of opioid addiction. In this way it can reap additional profits from the opioid epidemic that it helped to create.

While America wrestles with the worst drug crisis in its history, Big Pharma eyes even bigger profits.

The U.S. opioid painkiller market is worth an estimated $10 billion per year. The emerging market for drugs that treat opioid side effects, addiction, and overdose is already worth half that much. And it is poised for major growth in the years ahead.

It should come as no surprise that drug companies put profits before the public welfare. But Big Pharma’s attempts to capitalize on the worst drug crisis in U.S. history shows how nothing is off limits for the industry in its quest to create top-selling medications.

Drugs That Treat Opioid Side Effects

One of the most controversial moments of Super Bowl 50 did not occur on the field, but during an advertising spot.

The black and white ad—sponsored by AstraZeneca, Daiichi Sankyo, the U.S. Pain Foundation, and others—showed a forlorn man reacting to visual reminders of his constipation while a narrator intoned, “If you need an opioid to manage your chronic pain, you may be so constipated it feels like everyone can go… except you.”

Opioid induced constipation (OIC), the narrator explained, is “different, and may need a different approach.”

That approach, according to the commercial, was the use of medication—such as AstraZeneca’s and Daiichi Sankyo’s Movantik—specifically designed to treat OIC.

The Super Bowl ad spurred a backlash (and humorous takes) on social media, with many saying that it normalized opioid use. Vermont Governor Peter Shumlin tweeted that Big Pharma had “no shame” and was trying to “exploit a crisis for profit.”

But the ad was a success: AstraZeneca reported that Movantik prescriptions increased by one-third in the months following the Super Bowl. A single Movantik pill retails for about $10.

Opioid induced constipation reportedly afflicts 40-90 percent of opioid users. Researcher Jonathan Moss came up with an OIC treatment in the late 1990s to help cancer patients taking opioid painkillers. Drug companies, however, were not interested in a product that targeted such a limited patient pool.

As the opioid epidemic spread, drugmakers changed their tune. Now they are scrambling to enter a market that has blockbuster potential.

There’s a Pill for That

In 2014, AstraZeneca’s Movantik was the only OIC drug available. Today there are six name brand OIC drugs. By 2019, there could be as many as eight.

The market for OIC drugs in Western Europe and the United States is expected to grow from $67 million in 2016 to more than $650 million by 2019, including $563 million in the U.S. alone. Incredibly, the U.S. has less than 5 percent of the world’s population but consumes 80 percent of all opioids.

The U.S. has less than 5 percent of the world’s population but consumes 80 percent of the world’s opioids.

Until recently, doctors advised opioid patients to moderate their painkiller intake or use non-drug interventions such as changes in diet or exercise to treat constipation. Critics say that offering a drug for a condition caused by a drug not only encourages patients to continue using opioids unabated, but also incentivizes further drug use.

“The pharmaceutical industry literally created the [OIC] problem,” Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing told the Washington Post. “They named it, and they started advertising what a serious issue it is. And now they’ve got the solution for it.”

Dr. Kolodny explains the vicious cycle of drug use that can trap opioid users as they try to balance out from the side effects of the potent painkillers.

“Many patients wind up very sedated from opioids, and it’s not uncommon to give them amphetamines to make them more alert. But now they can’t sleep, so they get Ambien or Lunesta. The amphetamines also make them anxious, paranoid and sweaty, and that means even more drugs,” he said.

Other common opioid side effects that may require medication include nausea, central nervous system effects (such as cognitive dysfunction and agitation), and pruritus (itch).

Drugs That Treat Opioid Addiction

In 2014 (the most recent year for which data is available), nearly 2 million Americans abused or were dependent on prescription opioids. Even a single opioid prescription can lead to long-term opioid use. As many as 1 in 4 patients who are prescribed opioids struggle with addiction.

Treatment for opioid addiction is critically important due to the risk of overdose deaths. In 2015, more than 15,000 people died from prescription opioid overdoses.

Methadone

Drugs to treat opioid addiction have been around for nearly a century. Methadone—itself an opioid—was first manufactured in the 1930s in Germany as a less-addictive alternative to morphine. Methadone made its way to the States after World War II and was produced by Eli Lilly under the brand name Dolophine.

In the 1950s doctors began using methadone to treat opioid dependence. This trend strengthened in the 1960s as heroin-addicted American soldiers returned from Vietnam. Today, about 500,000 people are participating in methadone treatment programs for opioid addiction.

Since the onset of methadone is mild, it doesn’t produce the euphoria that other opioids do. But it reduces drug cravings and prevents the harsh withdrawal that often triggers an addict’s relapse.

Methadone treatment programs are controversial. Some believe “Just Say No” doesn’t work and that the programs are a pragmatic way to fight addiction. Others claim that replacing one opioid addiction with another doesn’t solve the underlying problem.

Then there is the financial angle. Methadone clinics can cost up to $76 per day per patient. Government-subsidized methadone treatment costs taxpayers more than $1 billion per year. In 2016, the federal government pledged more than a billion dollars to states for medication-assisted opioid dependence treatment (i.e., methadone treatment).

Those who oppose using public funds for medication-assisted treatment say it is unfair and unethical that taxpayers subsidize drug companies and for-profit treatment programs that provide legal opioids to addicts.

Jeff Sessions called the $1.3 billion false billing scam “the largest health care fraud takedown in American history.”

This summer the federal government announced a crackdown on healthcare fraud involving opioid treatment programs. That announcement followed a Justice Department takedown of a $1.3 billion false billing scam that Attorney General Jeff Sessions called “the largest health care fraud takedown in American history.” Of the 412 defendants, 120 were charged with opioid-related crimes.

As investors pour big money into addiction treatment and fraudsters try to cash in on false opioid billing, it would appear that the opioid crisis is providing financial opportunities for more than just drug companies.

(Click below for more.)

New Blood Pressure Guidelines a Boon for Big Pharma

Studies show that treating prehypertension with medication is often ineffective and unnecessary, raising questions about the AHA and ACC’s motives.

The American Heart Association (AHA) and the American College of Cardiology (ACC) released new guidelines earlier this month which lower what they consider to be “healthy” blood pressure levels.

Previously, blood pressure above 140/90 was considered high. Now, anything above 120/80 is considered elevated; above 130/80 is considered stage 1 hypertension; and above 140/90 is considered stage 2 hypertension.

The AHA and ACC modified the guidelines in hopes that with more advanced warning, more Americans may be able to take preventative measures to lower their blood pressure before it causes a life-threatening incident like a stroke.

“High blood pressure should be treated earlier with lifestyle changes and in some patients with medication,” said the ACC in a statement.

But studies show that treating prehypertension (now Stage 1) with medication is often ineffective and unnecessary, raising questions about the AHA and ACC’s motives to change blood pressure guidelines.  

Mild Hypertension is Already Overtreated, Physicians Warn 

The number of patients recommended for treatment will increase by 7.5 million people.

Under the new guidelines, the number of Americans with mild hypertension will increase by 26.8%, meaning that half of all Americans will now be considered to have elevated blood pressure.

Were the old blood pressure guidelines too high, leaving some Americans vulnerable to developing heart disease or having a stroke? Not necessarily.

Even back when 140 was considered “mild” hypertension (now it’s stage 2), a 2014 report in the journal BMJ argued that mild hypertension was overtreated.

“Evidence suggests no net benefit from drug treatment of mild hypertension in people without the higher risks of diabetes or chronic kidney disease,” authors Dr. Stephen Martin and Dr. James Wright wrote. “Nevertheless, most people with mild hypertension are treated with drugs.”

And it’s costing us. The U.S. spends $32 billion each year on mild hypertension alone. That number is now set to spike: The number of patients recommended for treatment, including prescription drugs, will increase by 7.5 million people, and 13.9 million more people will be recommended for more intensive treatment.

The AHA did recommend that medication should only be prescribed to those with Stage 1 hypertension if they have had a heart attack or stroke in the past, or if they are at high risk of having a cardiovascular event because of their age, existing chronic kidney disease or diabetes, or their risk of developing atherosclerotic disease.

This recommendation still leaves enough grey area for medications to be prescribed though, and the AHA did nothing to steer physicians away from over prescribing medication to patients with blood pressure over 140. In fact, by labeling it as Stage 2 hypertension rather than Stage 1, they made medication seem even more necessary, not less.

AHA’s Financial Ties to Big Pharma

“When individuals have commercial ties they are vulnerable to developing subtle, but sometimes powerful, pro-industry ways of thinking.”

If these new blood pressure numbers may cause more harm than good, then why did the AHA and ACC change them? Financial incentives may be to blame.

Of the 15-member panel responsible for writing the new guidelines, six had financial ties to the pharmaceutical industry, including the panel’s co-chair. The panelists had ties to pharmaceutical companies like Merck, Pfizer, and AstraZenecaall of which manufacture drugs that treat hypertension. These ties may include anything from paid consulting positions to all-inclusive conference packages at luxurious resorts. 

It isn’t just the panelists who have ties to Big Pharma; the association leadership does, too.

Overall, the AHA received $30 million from pharmaceutical and medical device manufacturers in the 2015-16 fiscal year.

Former AHA Research Committee Chair Joseph Broderick received over $20,000 in industry payments from 2013 through 2014, while AHA’s 2015-16 president, Dr. Mark Creager, received more than $30,000 from Novartis and AstraZeneca between 2013 and 2014.

Lisa Cosgrove, Fellow at the Edmond J. Safra Center for Ethics at Harvard University, explained the dangers of pharmaceutical ties on committee guidelines in a Forbes article: “When individuals have commercial ties they are vulnerable to developing subtle, but sometimes powerful, pro-industry ways of thinking.”

It certainly seems plausible when you look at former AHA President Dr. Robert Eckel’s actions, who received nearly $33,000 in industry payments in 2014. He testified in front of the FDA in favor of Praluent, a cholesterol-lowering drug, and also co-authored AHA’s guidelines on the “Treatment of Blood Cholesterol,” in which he explained how more Americans could benefit from statins.

Statins, Dr. Eckels wrote, “Could be prescribed to an estimated 33 million Americans without cardiovascular disease who have a 7.5 percent or higher risk for a heart attack or stroke within the next 10 years.”

Institute of Medicine Fights Conflicts of Interest

From 2003 to 2008, more than half of the American Heart Association and American College of Cardiology’s health guideline authors had conflicts of interest (56% of the 498 authors). Of those who led AHA’s panels, 81% reported financial conflicts of interest.

It’s a problem that the Institute of Medicine (a division of the National Academies of Science, Engineering, and Medicine) is trying to fight. In 2011, they issued new committee guidelines which proposed that leadership and the majority of committee members be free from conflicts of interest. 

Having guidelines is one thing—the next step is getting researchers to follow them.

Researchers at the University of Maryland School of Medicine reviewed 130 clinical practice guidelines to see how many were already following IoM’s recommendations. According to the study results, as of June 2011, more than two-thirds of committee chairs and 91 percent of co-chairs reported a conflict of interest. Less than half of committees at the time even reported their ties to the industry.

Suffering from Severe Side Effects?

Regardless of why the blood pressure guidelines were lowered, we do know that millions more Americans will be prescribed medication which may do more harm than good. Benicar and its sister drugs Azor and Tribenzor have been connected to intestinal issues like sprue-like enteropathy, and Lisinopril (or Zestril and Prinivil) has been associated with an increased risk of liver damage and liver failure.

If you or a loved one suffered severe side effects from a medication, you may be eligible for a lawsuit against the manufacturers. Contact us today for a free, no-obligation legal review.

How to Make a Billion Dollars in the Pharmaceutical Industry

This article was written by James Young, a ClassAction.com attorney who is nationally known in the areas of pharmaceutical litigation, health fraud, and consumer protection. Along with John Yanchunis, Mr. Young is now in the process of filing lawsuits against opioid distributors, doctors, and state Boards of Pharmacy on behalf of several counties in West Virginia, as well as the state of Kentucky.

James Young presented a version of the following in a live video for ClassAction.com’s Facebook page.

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Pharmaceutical companies approach new drugs with one question in mind: How do we make $1 billion?

Big Pharma’s push to create the next blockbuster drug is a highly sophisticated campaign that relies on numerous tried-and true tactics—some aboveboard and some fraudulent.

Big Pharma’s focus on profits often comes at the expense of patient safety.

Given the attention to detail that goes into developing and selling pharmaceuticals, when a drug produces serious, unwarned against side effects, it’s hard to believe manufacturers when they claim ignorance. And as drug lawsuits are often able to show, burying unfavorable safety data is in many cases part of Big Pharma’s marketing calculus.

A compound’s path from initial approval to blockbuster drug typically follows the eleven steps outlined below.

1. Take an existing drug or patent-protected medication and expand its use. Or, create a disease.

Pharmaceutical companies have intellectual property in the form of drug formulations. But they can’t make any money off a formulation until it is approved by the FDA to treat certain symptoms of a disease. So the first step is to approach the FDA and seek permission to use a drug for a particular treatment. The general timeline to complete research and approvals for a new drug is four-to-six years.

If there is no disease criteria consistent with the symptoms that a company’s drug treats, then the company creates a disease.

If there is no disease criteria consistent with the symptoms that a company’s drug treats, then the company simply creates a disease. They pay for physicians and research institutions and universities to come up with different disease criteria that are consistent with the symptoms that the drug treats. At the same time, they’re building grassroots support with patient support organizations they either created or funded that demand more medication options.

2. Hide data and obtain broader approvals.

In addition to clinical trials, drug companies also conduct their own tests called “surveillance” of the existing use of these drugs in the population. Drug surveillance produces very robust data sets that reveal to manufacturers the harmful side effects of drugs. Manufacturers are supposed to warn the public about the harmful side effects of drugs in the drug’s label.

But they don’t always do that. When they don’t, it leads to product liability litigation against the pharmaceutical company.

By hiding data—including safety data—companies are able to obtain broader approvals or indications for the use of their drugs. A company can’t make a billion dollars on a drug if they can’t sell it to a broad market.

Purdue Pharma’s OxyContin, for example, was initially approved to treat end stage cancer pain, or “breakthrough” pain. But because the market for breakthrough pain was too small to create a billion-dollar drug, Purdue got the FDA to sign off on using OxyContin for chronic pain, which is very different than breakthrough pain and has a much larger patient pool.

3. Broaden the market by creating false front or support groups.

Let’s say you’re an American pharmaceutical company and you want a patient advocacy group to promote the approval and use of your product. If an advocacy group won’t do that or doesn’t exist for the disease or symptoms your drug targets, you just create it. You fund the group through various non-transparent sources and create grassroots support, such as people demanding more pain medications for veterans coming back from Iraq.

The reality is, many of the support groups and patient advocacy groups are funded by Big Pharma itself. Many are not legitimate.

4. When in doubt, just pay kickbacks.

Since it’s a crime in this country to pay a physician a kickback for writing a prescription, drug companies use various workarounds.

Physicians make a lot of money doing these events.

For example, a drug company approaches a doctor and says, “We would really like you and your team of physicians at your clinic or hospital to use our product. In exchange, we’re going to allow you to conduct a clinical trial at your facility. And we’re going to pay you on a per-patient basis to do that. And we’re going to give you free products to use in the offices, so your patients won’t pay out of pocket at all.”

That’s a form of kickbacks. It is sometimes allowable when done openly and transparently, but quite often it’s not.

Another form of kickbacks is recruiting physicians to be speakers for your pharmaceutical company at conferences and events. Physicians are paid to travel to and speak in luxurious resorts in places like Maui, South Beach, and Las Vegas. They also have “lunch and learns” and CME (continuing medical education) events in their own locations.

Physicians make a lot of money doing these events.

5. Conduct stealth or guerrilla marketing using key opinion leaders.

When a drug company pays kickbacks to a physician, they’re only trying to get that physician’s patients to use a product. Using something called “key opinion leaders” allows a drug company to buy much broader influence.

By using stealth and guerilla marketing to target key opinion leaders—to figure out who they are, track their movements through social media and sales representatives that call on them in the office, by paying them kickbacks and paying them to speak—you develop a key opinion leader that everyone else will follow.

For example, “Dr. Smith” is the number one physician in New York City for a particular disease. If a drug company can get Dr. Smith to start using and recommending their product, all the other doctors that listen to Dr. Smith will follow suit.

Big Pharma finds a key opinion leader not just in one city, but in every city across the United States.

6. Enter into collusive agreements with pharmacy benefit management companies (PBMs) or the competition.

Pharmaceutical companies enter into antitrust or collusive agreements with insurers or PBMs (Pharmacy Benefit Management Companies, the insurance component of your pharmacy benefit) and pay rebates or kickbacks to them in order to lower their price and become number one on the formulary.

Drug companies rig the system by paying the competition to keep their products off shelves.

They’ll also do collusive agreements with the competition. These are sometimes called “co-marketing” or “co-branding” agreements. Maybe Company A is first to market with a particular product, but the competition is right behind them. If they come into market they might make $100 million in the first year. Company A can pay the competition not to market their drug and to instead co-market with Company A. They still get the $100 million but their product doesn’t hit the market.

There’s another variation of this involving generic drugs. When generic drugs come on the market, there’s no need (assuming that they’re the equivalent) for the branded version of that drug to continue to be on a PBM’s formulary. But quite often it remains. You can be sure that, behind the scenes, some type of co-marketing or co-branding has taken place.

(Click below for page 2.)

Senators Introduce Bill to Eliminate Billions in Medical Waste

A bipartisan pair of senators may have just charted a path to $765 billion.

On October 31, Amy Klobuchar (D—Min.) and Chuck Grassley (R—Iowa) introduced the Reducing Drug Waste Act of 2017. The cosponsors of the bill are Dick Durbin (D—Ill.) and Jeanne Shaheen (D—NH).

In a press release, Sen. Klobuchar said, “With the skyrocketing costs of prescription drugs, American taxpayers shouldn’t be footing the bill for medicine going to waste. Our bipartisan legislation would begin to address the problem of millions being spent on discarded drugs.”

“American taxpayers shouldn’t be footing the bill for medicine going to waste.”

Sen. Grassley cited a report which “indicated that Medicare and private insurers waste nearly $3 billion a year on cancer drugs that are distributed in vials that hold too much medicine for most patients.”

The act proposes that the U.S. Food and Drug Administration (FDA) team with the Centers for Medicare and Medicaid Services (CMS) to curb waste and “better manage costs with respect to vial sizes and other drug delivery systems like eye-drops.”

The impetus for the bill was a series of reports by nonprofit newsroom ProPublica, which found that medical waste costs taxpayers billions of dollars a year.

Droppers Dispense Twice as Much Liquid as Needed

In one striking example, ProPublica found that oversized eyedrops cause consumers’ prescriptions to run out much sooner than they should, forcing them to buy another vial. Most eyedroppers release far more liquid than the eye can hold; the excess liquid runs down the person’s cheek or is absorbed by the tear ducts.

Physicians have long known about this waste.

The drops can be twice as large as they need to be—which means the bottle runs out twice as fast and costs the patient twice as much.

Physicians have long known about this waste. A 1992 study in the American Journal of Ophthalmology found that microdrops were as effective as large drops, reduced side effects, and were the preferred treatment of patients.

Bill York, who helmed the study while working for eye care company Alcon, lobbied his employers for “microdroppers,” to no avail. Dr. Alan Robin, an ophthalmologist in Baltimore who consulted on the microdrop study, says he cried tears of joy when he learned of the Reducing Drug Waste Act.

“I’m literally crying with joy,” Dr. Robin told NPR. “I’m very concerned about both the cost issues associated with the waste, the side effects on patients, and also the environmental impact of waste.”

Last year several glaucoma patients filed a class action lawsuit against Alcon, Allergan, Bausch & Lomb, Merck, Pfizer, and Prasco alleging financial harm as a result of this industry-wide system of producing oversize droppers. That lawsuit was certified as a class action last year, then tossed before being revived two weeks ago.

The plaintiffs say these oversize droppers cost them thousands of dollars and amount to “an unfair and unscrupulous scheme.”

Healthcare System Wastes $765 Billion a Year

Eyedroppers aren’t the only case of squandered resources, unfortunately. The ProPublica series has brought to light a jaw-dropping amount of medical waste:

  • Hospitals throw away countless perfectly good, usable instruments (surgical staplers, surgical masks, catheters, ventilators, etc.). The article notes a 2012 study which estimated that our healthcare system wastes $765 billion a year.
  • Nursing homes toss, flush, or burn leftover prescription drugs at an alarming rate. One employee estimated that dozens of nursing homes destroy about 20 percent of the drugs they receive.
  • Drug makers often combine two cheap, generic drugs; slap a brand name on it; and sell it at an exponentially higher cost. One example, Vimovo, cost $3,252 for a month’s supply—versus $40 for the two drugs it combines, Aleve and Nexium.
  • Perhaps least surprising (but no less frustrating), several studies show that many drugs remain safe and effective long after their “expiration dates.” Reevaluating how we set these dates could save hospitals, pharmacies, and consumers billions of dollars.

The question, of course, is whether Congress can weather the flood of cash from Big Pharma and hold its ground. Last year drug makers spent $246 million on lobbying—the most of any industry.

That strategy has worked up until now (it usually does), but with soaring drug and healthcare costs rattling more and more consumers, the tide may turn.

PharmaTech Faces Lawsuits for Burkholderia Cepacia Outbreak

An outbreak of Burkholderia cepacia, a bacteria resistant to common antibiotics, affected 60 people across eight states last year. The culprit? Diocto Liquid, an over-the-counter laxative commonly used to treat constipation.

After the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Department of Health and Human Services investigated the outbreak, they determined that it was caused by contaminated water at PharmaTech’s manufacturing facility in Davie, Florida.

ClassAction.com is now filing lawsuits against PharmaTech and its distributors on behalf of individuals who fell gravely ill from B. cepacia-contaminated Diocto Liquid.

Read the Complaint

Why Is Burkholderia Cepacia So Dangerous?

Burkholderia cepacia is a group of bacteria found in soil, water, and other moist environments.

While the bacteria is generally harmless to healthy individuals, it can cause life-threatening infections in those with weakened immune systems. It is most commonly found in medicine and medical devices, making it doubly dangerous for hospital patients. People with chronic lung infections, like cystic fibrosis, are also vulnerable to B. cepacia.

“Recent outbreaks involving contaminated medicines and medical devices are particularly dangerous and have caused serious permanent injuries and, in some cases, death.”

B. cepacia is resistant to common antibiotics, complicating patient treatment.

“B. cepacia is a scary bacteria,” said Michael Goetz, an attorney who leads ClassAction.com’s mass tort section.

“Recent outbreaks involving contaminated medicines and medical devices are particularly dangerous and have caused serious permanent injuries and, in some cases, death. Other products, such as baby wipes and mouthwash have previously been the subject of B. cepacia outbreaks.”

The FDA most recently warned of B. cepacia found in Doctor Manzanilla cough, cold, and allergy medicines, made by Mid Valley Pharmaceutical.

Investigations Confirm PharmaTech Behind Multistate Outbreak

PharmaTech was the subject of multiple investigations last year when their Docusate sodium solution was linked to B. cepacia infections in eight different states.

The FDA, CDC, and Department of Health and Services investigations found multiple gaps in quality control processes at PharmaTech’s Davie, Florida manufacturing facility. These included a failure to monitor water quality or conduct final product testing for potential contamination.

The FDA found B. cepacia in 10 Diocto Liquid lots manufactured between 2015 and 2016. The source, they believe, was PharmaTech’s water supply which also tested positive for the bacteria. They later confirmed that the contaminated water was the source of the multistate outbreak.

On July 16, 2016, the FDA announced a recall of all non-expired Diocto Liquid distributed by Rugby Laboratories for B. cepacia contamination. By August, they expanded the recall to include all liquid products made by PharmaTech.

PharmaTech Sued After Infant Contracts Life-Altering Illness

Anderson Moreno, an infant living in Michigan, took Diocto Liquid as recommended and directed by his physician while awaiting a heart transplant. The solution was contaminated with B. cepacia and Anderson subsequently fell gravely ill with a bacterial infection.

The infection weakened Anderson’s heart, which necessitated a left ventricular assist device. It also resulted in a delay of his heart transplant and permanent kidney damage, requiring lifelong dialysis. 

ClassAction.com filed a lawsuit against PharmaTech, Harvard Drug Group, Rugby Laboratories, and Cardinal Health on behalf of Anderson and his parents, Alicia and Andrew Moreno.

“Because the source of infection may not be readily apparent, anyone who has been infected by the B. cepacia bacteria should seek legal advice.”

In the complaint, they allege that the defendants negligently designed, manufactured, tested, advertised, promoted, marketed, sold, and/or distributed Diocto Liquid. These actions, they allege, allowed the solution to become contaminated with B. cepacia, and later sold and distributed in its defective condition.

The Moreno family requests past and future compensatory damages for pain and suffering, loss of enjoyment of life, emotional distress, medical expenses, and lost earnings.

Though the source of PharmaTech’s B. cepacia outbreak is now confirmed, in many cases it can be difficult to track.

“Because the source of infection may not be readily apparent, anyone who has been infected by the B. cepacia bacteria should seek legal advice,” said Attorney Goetz.

Infected with Burkholderia Cepacia? We Can Help

If you or a loved one were infected with B. cepacia, you may be eligible for a lawsuit against the manufacturer, distributor, and other responsible parties.

ClassAction.com’s attorneys have recovered more than $5 billion for its clients against negligent corporations, including big pharmaceutical companies like PharmaTech. With more than 350 attorneys across 40 offices, our firm has the resources and experience to tackle Big Pharma. Contact us today for a free, no-obligation legal review.

Blood Thinners Like Xarelto Lead to More E.R. Visits than Opioids

Drug injuries have increased twofold in the last decade, according to the Food and Drug Administration’s adverse event database. Out of the more than one million adverse events reported to the FDA just last year, patients complained of their blood thinners the most.

The Institute for Safe Medication Practices (ISMP), a nonprofit organization, provided a breakdown of the pharmaceutical drugs that received the most injury and adverse event reports in their recently released 2016 annual report. Blood thinners, or anticoagulants, were connected to 21,996 adverse events and 3,018 deaths.

This group of pharmaceutical drugs includes Xarelto, Pradaxa, Eliquis, Warfarin, Coumadin, and Savaysa. Xarelto, a drug which is linked to thousands of lawsuits, was responsible for the bulk of adverse event reports.

Blood Thinner Risks Are “Unacceptably High”

Patients who are at risk of developing blood clots—which can potentially stop blood flow to vital organs—are often prescribed anticoagulants. Each blood thinner targets a particular blood clotting factor to prevent or reduce the formation of blood clots.

Blood clotting isn’t always bad though; in fact, in most cases, it’s vital in preventing small bumps and cuts from turning into severe bleeding events. By preventing this natural healing process from occurring, especially when the drug’s concentration is too strong, some patients may suffer from uncontrollable bleeding.

In 2016, internal hemorrhages made up the bulk of blood thinner injuries reported to the FDA:

  • 17,218 reported anticoagulant-related hemorrhages
  • 8,495 reported gastrointestinal hemorrhages
  • 1,019 reported cerebral hemorrhages

Some of these events were serious enough to require an emergency room visit. Overall, the ISMP authors warn, 6.3% of patients on blood thinners will require an E.R. visit, and half of those visits will require hospitalizations.

These numbers surpass any other type of drug. Altogether, anticoagulants were responsible for 17.6% of all FDA-reported hospitalizations.

“The manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”

It’s a statistic that should raise alarms in the medical community. Patients on blood thinners were 2.4 times more likely to require an E.R. visit than patients who were prescribed opioids—a drug type currently responsible for the nation’s worst drug epidemic.

ClassAction.com attorney Michael Goetz is part of the Plaintiffs’ Steering Committee for the Xarelto multidistrict litigation (MDL), filed in the federal Eastern District of Louisiana. The MDL includes thousands of claims alleging injuries caused by Xarelto.

“These new results are not surprising and confirm what we’ve said from the beginning: that certain members of the patient population are at heightened risk for major bleeding events while on Xarelto,” he told us. “In the absence of stronger warnings or a way to monitor a patient’s Xarelto concentration level or an antidote, the manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”

Xarelto’s Once-Daily Dosage Problem

Monitoring blood thinner concentration level is important in that the medication can create “peaks and troughs” in the drug’s severity for some patients.

It’s a particular problem for Xarelto’s once-daily dosing, which has been marketed as a more convenient alternative to the generic warfarin, which requires twice-daily dosing.

But while a once-daily dosing may seem easier for the patient, it may leave them more vulnerable to strokes or bleeding events. Taking anticoagulants only once a day can create inconsistencies in the drug’s concentration—too weak at times (presenting a stroke risk) and too strong at others (making patients vulnerable to bleeding).

Xarelto also poses potentially greater health risks than Warfarin in that it does not require regular patient monitoring. Regular medical visits could help ensure patients receive an accurate dosage, one that prevents dangerous fluctuations in the blood thinner’s concentration. According to a 2017 Mayo Clinic study, one in six patients on newer blood thinners may be prescribed the wrong dosage.

Xarelto Still Lacks an Antidote

Of the 17,000-plus patients who suffered a blood thinner-related hemorrhage last year, those who were on Xarelto (rivaroxaban) did not have access to an antidote to help stop the bleeding. Without a reversal agent to stop blood flow, these events could quickly become life-threatening.

Pradaxa allegedly caused 1,000 deaths.

An antidote for Pradaxa (dabigatran) was only recently approved in 2015. Unfortunately, this was not soon enough to prevent the more than 1,000 casualties allegedly caused by the blood thinner.

An antidote, ISMP researchers stated, could reduce the amount of fatalities and serious injuries in patients significantly. Warfarin has had a simple vitamin K antidote available for years, but despite this major difference, Xarelto and Pradaxa were marketed as superior alternatives.

Thousands File Lawsuits Against Xarelto, Pradaxa

This dangerous risk of bleeding, combined with misleading advertising and an absence of warnings and antidotes, has resulted in thousands of lawsuits against Xarelto and Pradaxa manufacturers.

There are currently 14,000 Xarelto lawsuits consolidated in New Orleans. Thousands more have been filed in state courts against manufacturer Bayer and Janssen, the Johnson & Johnson subsidiary who markets the drug in the U.S.

In 2014, Boehringer Ingelheim (Pradaxa’s manufacturer) settled 4,000 of its lawsuits for $650 million. This was before an antidote was available, though, so some patients were still suffering from Pradaxa-related injuries. Because of this, litigation is likely far from over for Boehringer Ingelheim.

Blood Thinner Injury? We Can Help

ClassAction.com attorneys are filing lawsuits against Xarelto and Pradaxa manufacturers. If you or a loved one suffered uncontrollable bleeding while taking either blood thinner, contact us today for a no-obligation case evaluation. It costs nothing unless we win a jury award or settlement for you.

Trump Declares Opioid Crisis a National Emergency

(Above photo by Gage Skidmore)

(NOTE: On October 27, 2017, Donald Trump formally declared the opioid crisis a national public health emergency. He announced his intention to do so on August 10, 2017.)

In a seeming reversal from his previous stance, Donald Trump said yesterday that he was declaring the nation’s opioid crisis an emergency.

“I’m saying officially right now—it is an emergency. It’s a national emergency,” Trump said from his golf club in Bedminster, New Jersey. “We’re going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis.”

“I’m saying officially right now—it is an emergency.”

Prior to that announcement, Health and Human Services Secretary Tom Price had said that an emergency declaration was unnecessary. This surprised many after Chris Christie’s Commission on Combating Drug Addiction and the Opioid Crisis recommended the declaration to unlock government funding to combat the crisis.

Vox examined what the emergency announcement could mean in terms of actual policy, emphasizing that this is a nebulous issue. The declaration could free up funding and other support to help tackle the crisis, but experts agree that for it to be effective, it must be part of a large, comprehensive effort.

Tom Frieden, former head of the Centers for Disease Control and Prevention (CDC), tells Vox, “[I]t could help in the right context, as part of a comprehensive response, and if it encourages both funding and better collaboration between public health and law enforcement.”

But Frieden added, “If it’s just a political statement not backed by money or commitment to more action, and if it’s a way to propagate the criminalization of addiction, then it would be counterproductive.”

Six Thousand More Opioid Deaths Discovered

Trump’s declaration of a state of emergency came just days after a new study published in the American Journal of Preventative Medicine found that opioid deaths in 2014 were underestimated by 24 percent. If true, the total would rise from 29,000 to 35,000.

Opioid deaths in 2014 were underestimated by 24 percent.

The study, helmed by University of Virginia researcher Christopher Ruhm, also found that certain states were particularly guilty of underreporting opioid fatalities. In Alabama, Indiana, Louisiana, Mississippi, and Pennsylvania, the final tally was more than double the original number. (In New England, on the other hand, the original reports were largely accurate.)

Images: American Journal of Preventative Medicine

For the study, Ruhm examined more than 47,000 death certificates from 2014 for which the cause of death was marked as a drug overdose. In thousands of these cases, he found that an opioid overdose was the cause of death but that the local medical examiner had not marked the certificate as such.

There is no official standard for or definition of an opioid overdose, which helps account for the underreporting in several pockets of the country. In many cases, no drug was specified.

Ruhm’s study concludes that his corrections “supply important information to policymakers attempting to reduce or slow the increase in fatal drug overdoses.”

Research such as this could prove vital as the Trump administration tries to quell the opioid epidemic.

ClassAction.com Files Lawsuits Against Drug Distributors

To effect real change and hold the powerful accountable, ClassAction.com attorneys John Yanchunis, James Young, and Patrick Barthle have filed several lawsuits on behalf of towns and counties in West Virginia.

McDowell County’s fatal drug overdose rate is three times higher than West Virginia’s.

These complaints were filed against major drug distributors, pharmacies, pill mills, and physicians. They accuse the defendants of public nuisance, negligence, code violations, and unjust enrichment.

A lawsuit filed on behalf of McDowell County claims that claims that, in addition to spreading “addiction and destruction,” drug companies drained McDowell County’s finances:

Defendants have caused and will continue to cause McDowell County to expand substantial sums of public funds to deal with the significant consequences of the opioid epidemic that was fueled by defendants’ illegal, reckless and malicious actions…

ClassAction.com attorney John Yanchunis said: “McDowell County was once a thriving community, now laid to waste by drug addictions which have destroyed lives, broken up families and caused a dramatic increase in crime, addiction-related social and health issues, overdose and even death.”

McDowell County’s fatality rate from drug overdoses is nearly three times higher than West Virginia’s.

ClassAction.com attorneys are also exploring lawsuits on behalf of other states and counties, and on behalf of opioid victims. If you or a loved one became addicted to prescription painkillers, please contact us today to learn your rights. You may be owed money for damages caused by your addiction.

What’s Next After Largest-Ever Opioid Crime Sweep?

More than 400 arrests were announced last week in the Department of Justice’s largest-ever healthcare fraud takedown. The federal sweep involved crimes totaling more than $1.3 billion in fraudulent healthcare charges.

Defendants were charged with crimes ranging from fraudulent insurance charges (billing Medicare and Medicaid for services and treatments that were never provided), illegal drug prescriptions (particularly for opioids), and kickbacks for patient referrals and prescriptions.

“Too many trusted medical professionals, like doctors, nurses, and pharmacists, have chosen to violate their oaths and put greed ahead of their patients,” Attorney General Jeff Sessions said. “Their actions not only enrich themselves often at the expense of taxpayers but also feed addictions and cause addictions to start.”

120 Defendants Charged with Opioid-Related Crimes

The Justice Department’s recent crackdown is the largest federal effort to date in fighting the opioid crisis: 120 of the defendants were charged with opioid-related crimes

Among the opioid-related crimes that the DOJ reported were fake rehabilitation centers. One center in Florida was accused of defrauding the government of $58 million for rehabilitation services that they failed to provide. The center allegedly lured patients who were struggling with opioid addictions by offering gift cards and strip club visits. 

The roundup also targeted health care workers who illegally prescribed opioids for money and other kickbacks.

One doctor in Connecticut was accused of selling opioid prescriptions to drug dealers, which allegedly earned him $50,000 in one year. A Houston doctor allegedly prescribed 12,000 prescriptions for 2 million opioid doses in return for cash payments.

These crimes represent more than just stolen government money. For patients who are prescribed opioids like oxycodone, hydrocodone, methadone, or fentanyl for pain relief, they may be susceptible to developing a drug dependency. Tom Frieden, the director of the Centers for Disease Control, once told the Washington Post that “prescription opiates are as addictive as heroin.”

While the DOJ takedown is historic and a positive step in fighting the opioid crisis, the fight is far from over. Experts now worry that we may see a spike in drug overdoses if there isn’t a similar investment in rehabilitation.

An Investment in Rehabilitation Must Come Next

For many long-term opioid users, simply stopping their prescription isn’t an option. Withdrawal symptoms can be severe and can include anxiety, vomiting, abdominal pain, difficulty sleeping, and drug cravings.

Because of this, doctors must exercise caution when prescribing these powerful painkillers.

“I think doctors can play a central role in fighting the opioid crisis in several ways,” Dr. Michael Barnett, an assistant professor at the Harvard T. H. Chan School of Public Health, told us. “They are the front line of prescribing, and bear the responsibility of safely prescribing opioids when the benefit (pain relief) outweighs the risks (dependence and other side effects).”

Dr. Barnett recently researched the long-term effects of opioid prescriptions in a study published by the New England Journal of Medicine.

In that study, one out of 48 Medicare patients prescribed opioids in the emergency room became long-term users (someone who uses opioids for 180 days or more within the first 12 months of an emergency room visit). If patients saw a doctor who was a “high-intensity prescriber”—someone who prescribes opioids in 25% of their patients—they were 30 percent more likely than patients who were treated by “low-intensity” prescribers to use opioids in the long term.

“We should have a culture of transparency and accountability around opioid prescribing—we are all in this together.”

But, as more and more healthcare providers are cracking down on the number of opioid prescriptions, some long-term opioid users may seek other sources of relief if they aren’t properly treated for withdrawal symptoms. Some have turned to illegal opioid suppliers like drug dealers or pill mills, while others have turned to stronger drugs entirely. Heroin, for example, produces a similar effect to opioids and has seen a spike in usage.

Fighting the opioid crisis then requires a two-pronged approach: We must address the effects of addiction in addition to restricting opioid access. This is another area where Dr. Barnett feels doctors can make a difference.

“Doctors can play a key role in safely transitioning long-term opioid users off of the medications to alternative therapies as they are able, and to promote and prescribe medication assisted therapy for those with dependence,” said Dr. Barnett. “Above all, we should have a culture of transparency and accountability around opioid prescribing—we are all in this together.”

Attacking the Root of the Crisis: Pharmaceutical Companies

We can’t educate doctors and patients on the effects of opioids without addressing the source of the problem: the pharmaceutical companies.

“Drug companies such as KVK-Tech that manufacture opioids have an obligation to ensure their product is not diverted illegally and are safe to use,” John Mack, owner of Pharma Marketing News, told us.

“Drug companies that manufacture opioids have an obligation to ensure their product is not diverted illegally and are safe to use.” 

He explained that companies like KVK-Tech are not only failing to do all that they can to prevent abuse, but they may have even known that their opioids were going straight to illegal pill mills or pain clinics.

He points to a 2014 Drug Enforcement Administration case involving Masters Pharmaceutical. KVK’s representatives stated that the “majority of the oxycodone they manufactured was sold in Florida due to the demographics of the population, the prescribing patterns of Florida physicians, the prevalence of pain clinics, and laws which [then] allowed physicians to dispense controlled substances.” 

“This verges on knowing that much of its opioids may have been diverted by pain clinics operating illegally since federal authorities have long focused on Florida pain clinics as bad players in this crisis,” Mack explained.

“Aside from ensuring the safe and legal use of these products, opioid-producing drug companies should, in my opinion, fund local and national efforts to combat addiction to these drugs. In my community, for example, I urge KVK-Tech to fund a 24/7 drug drop-off box so residents can safely dispose of their unused drugs, including opioids.”

If we have any hope of fighting America’s opioid crisis, the federal government, medical community, and pharmaceutical companies must continue to hold themselves accountable for their roles in the epidemic.

This Arthritis Drug Has Been Linked to 1,100 Deaths

Roche’s rheumatoid arthritis medication Actemra has been linked to more than 1,100 deaths, prompting questions about why the drug does not have warning labels about potentially fatal side effects.

Evidence links Actemra to cardiovascular, lung, gastrointestinal, and pancreatic side effects.

Actemra (tocilizumab) competes with arthritis medications that include Humira, Remicade, and Enbrel. But unlike its competitors, Actemra does not warn about potential injuries and deaths from heart attacks, heart failure, strokes, lung disease, pancreatitis, and gastrointestinal perforation—even though there is evidence that the risks of these side effects are as high or higher for patients treated with Actemra than for patients who take competing drugs.

ClassAction.com is closely monitoring the emerging reports about deaths and injuries associated with Actemra. If you have experienced dangerous Actemra side effects that the labels do not warn about, please contact us and share your story.

13,500 Adverse Event Reports Involve Actemra 

Actemra was introduced to the U.S. market in 2010 to treat the disabling disease rheumatoid arthritis. Its introduction was met with enthusiasm since Actemra ostensibly was not associated with the potentially deadly cardiovascular and lung complications that its competitors are.

But according to a new report from STAT, Actemra is not as safe as the U.S. Food and Drug Administration (FDA) and Roche would lead consumers to believe. In fact, the STAT report suggests that Actemra is at least as dangerous as its competitors—if not more dangerous.

STAT analyzed more than 500,000 adverse event reports about several rheumatoid arthritis drugs, including over 13,500 reports involving Actemra, and uncovered 1,128 reports of Actemra patients who died while taking the medication. Many of these patients died from unwarned against cardiovascular and pulmonary side effects.

Highlights from the report reveal worrying trends for Actemra users:

  • More than 1,000 people died while on Actemra.
  • Actemra had similar rates of serious side effects compared to competitor drugs such as Humira and Remicade—despite the fact that Humira and Remicade have significantly more users.
  • Actemra users and Humira users have reported a similar number of cases of interstitial lung disease, while many more cases of lung disease were reported with Actemra than with Remicade. Actemra, unlike Humira and Remicade, does not warn about lung disease.
  • Similar results were found for heart attacks, strokes, and heart failure—conditions that Humira and Remicade warn about but Actemra does not.
  • Pancreatitis was reported in 132 Actemra patients. Twenty-six of these patients died. Pancreatitis can kill up to 50 percent of patients in its acute form.
  • STAT recruited experts to examine the data, and the experts said the FDA should immediately consider Actemra warnings for heart failure and pancreatitis. They also said that the possible link between Actemra and increased risk of heart attacks, strokes, and interstitial lung disease should be further investigated.

STAT points out that adverse event reports are not proof of causation between Actemra and the reported deaths. But it also notes that patient deaths could be higher because these voluntary reports only capture an estimated ten percent of adverse patient experiences.

“There Were Some Red Flags”

The STAT report on Actemra is not the first to raise concerns about the drug’s side effects.

Across five Actemra clinical trials, 72 percent of patients had an adverse side effect. One or more serious side effects occurred in 6 percent of patients. Four patients died of heart attacks, one from heart failure, and four from infections during clinical testing.

Nine patients died during Actemra clinical testing.

Infections, gastrointestinal perforations, cardiovascular complications, and other serious side effects prompted serious discussion during a meeting of the FDA’s advisory panel in 2008.

The panel voted ten-to-one to recommend approval of Actemra. The sole dissenter was consumer representative Diane Aronson.

Ms. Aronson said, “As a ‘no’ voter, I felt there wasn’t enough data; it was too short-term. There were some red flags.”

She added that ‘yes’ voters felt that “long-term studies will be acted upon” and warning labels adjusted if necessary. “That’s why they voted ‘yes,’” Ms. Aronson said.

FDA’s Ties to Roche Raise Questions

Roche received approval for Actemra on the condition that it would perform Phase IV clinical trials, or post-marketing trials. The FDA may recommend these additional safety studies when there is inconclusive evidence about a drug’s long-term safety.

Results from a phase IV trial of Actemra were presented at the 2016 American College of Rheumatology. Actemra patients were compared to patients taking competitor drug Enbrel. Actemra patients were found to have a 1.5 times higher rate of stroke and heart failure.

While the increase is not a statistically significant amount, this does not explain why Enbrel labels warn against prescribing the drug to patients with cardiovascular disease, but equivalent labels have not been added to Actemra.

All 11 authors of the Actemra Phase IV study disclosed financial ties to Roche or Genetech.

Since its 2010 approval, the FDA has scrutinized Actemra several times. A 2012 FDA investigation of Actemra data from several sources found 258 cases of pancreatitis and 185 cases of interstitial lung disease among users. Under pressure from Roche, the FDA declined to push forward with warning labels for these side effects.

The STAT article describes the possible conflicts-of-interest between FDA and Roche, including a former FDA manager who helped oversee Actemra’s approval and shortly after left for Roche, where he now works with the FDA to gain approval for new uses of the drug. And all eleven authors of the phase IV study published in 2016—which found an insignificant cardiovascular risk difference between Actemra and Enbrel—disclosed financial ties to Roche or its subsidiary Genentech.

In a 2013 safety review of Actemra, the FDA found 118 deaths associated with the drug, including 42 deaths from heart attack or heart failure. But once again, the agency failed to update the medication’s labeling, citing an inconclusive show of causality.

In May 2017, the FDA approved Actemra for use in patients suffering from giant cell arteritis, a move that expands the user base for one of Roche’s best-selling drugs. The agency, however, has yet to expand Actemra’s safety labeling.

Which raises the question: How many deaths and injuries will it take before the FDA and Roche do take action?

Opioid Regulation and the Art of Passing the Buck

This editorial was written by James Young, a ClassAction.com attorney who is nationally known in the areas of pharmaceutical litigation, health fraud, and consumer protection. Mr. Young has served in leadership positions in numerous multi-state Attorney General investigations, including starting and co-leading the largest consumer protection drug settlement to date, In Re Risperdal. He was appointed co-lead of the government plaintiffs group in the Vioxx Multi-District Litigation and served as lead of several litigation subcommittees. Along with John Yanchunis, he is now in the process of filing several lawsuits against opioid distributors, doctors, and state Boards of Pharmacy.

***

Last week the U.S. Food and Drug Administration (FDA) politely asked a drug company to take its blockbuster opioid medication off the market.

The drug, Opana ER, is an extended release form of the painkiller oxymorphone hydrochloride made by Endo. Patients have heavily abused the drug by crushing it up and snorting it, bypassing the extended release mechanism. (Note: This is a drug that the FDA has already approved as safe and effective; the FDA’s request pertains to the abuse and misuse of the drug.)

The FDA action is limited to a request, to which Endo has said it would evaluate misuse of the drug—not pull it from the market (not yet, anyway). In light of this refusal, the FDA could withdraw its approval of the drug, but such a move might be fraught with significant legal challenges.

The FDA’s request is a refreshing shift from an otherwise toothless watchdog.

Still, this latest move by the FDA is a refreshing shift from an otherwise toothless watchdog. Perhaps the most notable takeaway from the request is that, according to Commissioner Scott Gottlieb, the FDA is considering similar action against similar products. After decades of watching the FDA sit on its hands while opioids ravage the country, it’s a start.

In my opinion, though, this is a case of trying to chase one of the many horses back into the barn while the others roam free.

The full range of actors behind the opioid epidemic are researchers, manufacturers, state and federal regulators, drug distributors, pharmacies, providers, patients, and even street criminals. These drugs make billions of dollars for manufacturers and distributors, yet they wash their hands once they get the FDA’s blessing.

A cursory examination of their respective liability reveals no single entity serves as the gatekeeper or watchdog once a drug is approved. That raises the question: Aside from the FDA, which group among these players is or should be responsible for ensuring that these dangerous drugs don’t end up in the hands of the wrong people?

These drugs make billions of dollars for manufacturers, yet they wash their hands once they get the FDA’s blessing.

The drug industry has deftly created a host of “get out of jail” defenses by selectively and strategically picking their battles. For example: agency preemption, rejection of fraud on the FDA, commercial speech, and the “learned intermediary” theory.

Then Big Pharma’s lobbyists cook up bills like the 21st Century Cures Act, CAFA, FICALA, etc. Meanwhile, plaintiffs swing and miss in a disorganized confederation focused more on monetary recovery than changing practices. They also have to play defense in trying to fight the onslaught of conservative legislation.

When considering liability for the harm caused by prescription drugs, a defense theory exists called the learned intermediary theory. The basic premise is that manufacturers and distributors cannot be held accountable for damages caused by drugs since the drugs require a “learned intermediary” (the physician) to render an objective professional opinion that the patient needs the drug, thereby breaking the chain of causation. The logical conclusion, then, is to look to these learned intermediaries to stave off the epidemic.

Physicians will quickly point out that the patients who come to them—many of whom are solely seeking the pills, not actual relief of symptoms—must also be held accountable for misrepresenting their symptoms or lying about existing prescriptions. This is akin to a bartender defending a charge of over-serving by arguing that the customer said they were thirsty.

Pharmacies are keenly aware of how to navigate the regulatory morass to avoid being held accountable.

The liability of pharmacies is fairly limited once an actual prescription is presented, thus the buck is passed again. We could next look to the state and federal regulators like the Drug Enforcement Agency (DEA) and state Boards of Pharmacy and Medicine. To their credit, there seems to have been an increase in Board actions, but their regulatory framework limits what they can do. Physicians and pharmacies are keenly aware of how best to navigate through the regulatory morass to avoid being caught or held accountable.

If we go back to the beginning of a drug’s approval, particularly when considering opioids like Oxycontin, we find a collection of flimsy clinical support largely organized by the manufacturers themselves. In this modern era, it is hard to fathom that an agency like the FDA could be duped by false front organizations created by manufacturers, yet it happens.

There are numerous lawsuits pending or about to be filed against all of the above players, but these lawsuits largely seek money damages. In my experience, the seemingly large amounts recovered in such litigation pale in comparison to the actual profits for each of the players.

Who, then, is best suited to serve as a watchdog of the vulnerable population of current or future opioid addicts? The practical fix is to break down the barriers of regulatory accountability for every player in the chain, beginning with researchers and ending with pharmacists and providers.

If a physician chooses to open a pill mill, he or she should face quick but fair oversight by regulators.

If a physician chooses to open a pill mill, or a pharmacy wishes to dispense to known addicts, they should face quick but fair oversight by regulators. When appropriate, these players should permanently lose their ability to operate such practices. If a manufacturer creates phony support for its drug approvals, or withholds material information from the FDA, the drug should be pulled from the market.

Of course, the current climate in Washington, D.C. will never expand legal liabilities for these players or reinforce regulatory oversight. When we reduce legal liability and reduce regulations and appoint industry shills to lead government agencies, as this Congress has, it is a recipe for disaster.

The buck has been passed, and we the people are left to pick up the pieces in the aftermath.

There Are Now Roughly 20,000 Risperdal Lawsuits

Given that Risperdal labels initially described gynecomastia as a “rare” side effect, there sure are a lot of lawsuits stemming from the condition.

In its annual report at the end of February, Johnson & Johnson (the parent company of drug maker Janssen) announced that it faced 18,500 Risperdal lawsuits in the United States and Canada.

Plaintiffs filed more than 3,000 Risperdal lawsuits in Philadelphia in the first quarter of 2017.

Since that report, at least 500 Risperdal lawsuits have been filed in Philadelphia alone, bringing the total to at least 19,000 and perhaps as many as 20,000 across America and Canada.

Plaintiffs filed more than 3,000 such lawsuits in Philadelphia in the first quarter of 2017. An additional 310 lawsuits have been filed there in the past two months, for a total of 5,815 as of this writing.

Those numbers are staggering, but so are the side effects—and the jury awards.

Gynecomastia Risk Was 23x What Label Said

Risperdal is an antipsychotic medication used to treat attention deficit disorder (ADD), bipolar disorder, and other mental health issues. Studies show that the drug can cause young boys to develop female breast tissue—a condition known as gynecomastia.

Risperdal plaintiffs allege that Janssen understood the full extent of the gynecomastia risk but failed to adequately warn patients. Originally Risperdal labels claimed that gynecomastia occurred in fewer than one in 1,000 patients.

But after 13 years on the market (1993-2006), Janssen updated the labels to state that 2.3 percent of patients—more than 20 times the original rate—would suffer this severe side effect.

Originally Risperdal labels claimed that gynecomastia occurred in fewer than one in 1,000 patients.

As a result of Janssen’s failure to warn, lawsuits allege, these boys’ bodies transformed in a way that rendered them confused and ashamed.

Many of these boys are now men who have had to undergo surgery to remove their breasts. Adding insult to injury, many also gained a substantial amount of weight (allegedly from Risperdal) and had to shed those extra pounds before going under the knife.

But after years of being bullied for their bodies, they are fighting back.

“Risperdal Boys” Photo Series Brings Trauma to Light

Besides filling lawsuits to hold Janssen accountable, another way Risperdal victims can take action is by raising awareness of the gynecomastia side effect. This could ramp the pressure up on Janssen to make the situation right. But more importantly, it lets other victims know that they’re not the only ones suffering from this condition.

“They wanted the world to know what happened to them.”

With this in mind, a photographer named Richard Johnson recently published a series of photos called “Risperdal Boys.” This project presents three photos each of six boys (now men) who allegedly grew breasts after taking Risperdal. (There were going to be ten Risperdal Boys, but four of them ultimately decided that they did not want their photos to go public.)

Of the six who did participate, Mr. Johnson tells PetaPixel, “…it was because they wanted the world to know what happened to them. Most of the young men in the project suffered alone; they’ve never met someone else with their condition.”

Thanks to the Risperdal Boys’ bravery, dozens if not hundreds more boys will know that they’re not alone.

Juries Side with Plaintiffs, Awarding Them Millions

Juries have not taken lightly the suffering of Risperdal plaintiffs. Last year J&J lost four individual Risperdal lawsuits that went to trial. The awards in the first three cases totaled nearly $5 million, with Austin Pledger alone receiving $2.5 million.

But even those numbers pale in comparison to Andrew Yount, who was awarded $70 million by a Philadelphia jury in July 2016. They ruled that J&J had not only failed to warn Mr. Yount about taking Risperdal, but had destroyed evidence related to the case.

By that point, Johnson & Johnson had already racked up $30 billion in Risperdal sales.

The U.S. government has aimed to punish Janssen for its handling of Risperdal. In 2013, the Department of Justice fined the company $2.2 billion for its off-label marketing of the drug.

By that point, Johnson & Johnson had already racked up $30 billion in Risperdal sales. Last year alone, the drug generated $800 million.

Keep that in mind if—or, more likely, when—J&J settles these thousands of lawsuits.

J&J Wins Xarelto Bellwether, but Pays for Talc & Mesh

The company still faces thousands of talc and Xarelto lawsuits, and hundreds for transvaginal mesh.

Johnson & Johnson has been on a litigation rollercoaster after receiving major verdicts for talcum powder, transvaginal mesh, and Xarelto.

While the latest talc and transvaginal mesh verdicts were favorable for plaintiffs, Johnson & Johnson’s subsidiary Janssen Pharmaceuticals was cleared of allegations in the first Xarelto bellwether.

Despite the outcomes of these verdicts, Johnson & Johnson still has a long road ahead of them before they are free from litigation. The company still faces thousands of pending talc and Xarelto lawsuits, and hundreds for transvaginal mesh.

$110M Talcum Powder Verdict is the Highest Yet

On May 4, Johnson & Johnson was hit with its highest verdict yet for talcum powder: $110 million, including $5.4 million in compensatory damages and $105 million in punitive damages. A St. Louis jury sided with Lois Slemp, who alleged her ovarian cancer was caused by using Johnson & Johnson’s baby powder and shower-to-shower powder products for four decades.

Ms. Slemp’s attorneys presented studies linking ovarian cancer to talcum powder use, and alleged that Johnson & Johnson’s executives were aware of the risks. 

“They chose to put profits over people, spending millions in efforts to manipulate scientific and regulatory scrutiny,” said Ted Meadows, co-lead counsel for Ms. Slemp. “I hope this verdict prompts J&J to acknowledge the facts and help educate the medical community and the public about the proper use of their products.”

The verdict comes after a string of major talc losses for Johnson & Johnson, including three substantial verdicts last year: $72 million in February, $55 million in May, and $70 million last October. These lawsuits similarly alleged that executives knew of talc’s cancer risk but failed to warn the public and medical community.

The company still has 2,500 cases to battle in the Missouri multidistrict litigation (MDL), and have already said they will appeal the $110 million verdict.

J&J Subsidiary Hit with $20M Mesh Verdict

Just days before the record-breaking talc verdict, Johnson & Johnson’s subsidiary Ethicon was hit with its third multi-million dollar verdict for its TVT-Secur device, a type of transvaginal mesh.  

A jury in the Philadelphia mass tort awarded Peggy Engleman $20 million ($2.5 million in compensatory damages and $17.5 million in punitive damages) for the ongoing complications she still suffers from the device, including chronic vaginal pain, permanent urinary dysfunction, and pelvic floor spasms.

“While verdicts are important to the litigation, there is still work to be done.”

Ms. Engleman received the device in 2007 for stress urinary incontinence. But within a month, she alleged the device failed and began to erode in her body. She underwent three surgeries to remove the device, but physicians were unable to remove it in its entirety. 

It’s a story that is sadly too common among plaintiffs, and it’s not the first time Johnson & Johnson has shelled out millions for the mesh. They were hit with a $12.5 million verdict in 2015 and a $13.5 million verdict in 2016. 

“While verdicts are important to the litigation, there is still work to be done,” said Yaeger. “I expect J&J to appeal the transvaginal mesh verdict and continue their hard press to litigate the cases.”

Plaintiffs Attorneys Still Hopeful After First Xarelto Trial

Amid the headlining verdicts came a somewhat rare victory for Johnson & Johnson when they won the first Xarelto bellwether on May 3.

Xarelto is manufactured by Bayer but marketed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. The blood thinner has been linked to reports of uncontrollable bleeding in patients, for which there is no antidote. 

14,000 of the nearly 18,000 Xarelto lawsuits are consolidated in a federal court in New Orleans under the jurisdiction of Judge Eldon Fallon. The other cases are consolidated in Pennsylvania and Delaware state courts.

The first bellwether in the New Orleans MDL was filed by Joseph Boudreaux who suffered gastrointestinal bleeding after taking Xarelto for irregular heartbeats and a high risk of stroke. The internal bleeding was so serious that it resulted in a week-long stay in the ICU and required blood transfusions and multiple heart procedures.

Boudreaux’s suit rested on one allegation: That his cardiologist didn’t receive proper safety information for prescribing Xarelto. Specifically, the lawsuit alleged, Bayer and Janssen should have instructed physicians to perform tests to assess the bleeding risk of patients. However, the jury did not find Bayer and Janssen liable for these failure to warn claims.

The narrow scope of Boudreaux’s claims make it hard to predict the outcomes of the remaining three bellwethers, some attorneys point out.

“As plaintiff’s lawyers, we wonder what it looks like if the full set of claims were there—here, it ended up being very limited to just this additional testing issue,” plaintiff’s attorney Max Kennerly told Law360.

The next bellwether is scheduled for the end of May. The lawsuit was filed by Joseph Orr who alleges his wife died from a brain hemorrhage caused by taking Xarelto. In addition to accusing the company of failure to warn, the suit also claims the medication lacked a reversal agent for fatal bleeding incidents.

Johnson & Johnson may have pledged to keep fighting, but so have our attorneys. If you or a loved one suffered injuries from a medication or medical device, contact us for a free, no-obligation legal review.

How to Solve the Opioid Epidemic

The worst drug overdose crisis in American history shows no sign of slowing, despite growing public awareness.

More than 50,000 Americans died from drug overdoses in 2015—the most ever. Nearly two-thirds of the deaths were linked to opioids such as OxyContin, Percocet, heroin, and fentanyl.

Drug overdoses are now killing more people than during past heroin, cocaine, and methamphetamine epidemics. The 33,091 opioid related deaths in 2015 represents a fourfold increase since 1999. Nearly half of those deaths involved a prescription opioid.

Efforts are underway that could finally produce a breakthrough in the crisis.

Every day, news headlines speak to the deepening opioid crisis. In Eerie County, New York, there were ten opioid deaths during a single week in April. Fifty people recently died in a single day from a batch of heroin in Philadelphia, where 900 people are projected to die from opioids this year. Hennepin County, Minnesota experienced a nearly 60 percent jump in opioid deaths from 2015 to 2016. In Palm Beach County, Florida, opioid overdose deaths nearly doubled in 2016. Colorado saw 56 homicides in 2016, compared to 442 opioid-related deaths.

Our country desperately needs new solutions for this unprecedented public health crisis. Initiatives such as more drug treatment and increasing access to overdose antidotes—while helpful—ignore the role of Big Pharma, which every year floods the market with enough painkillers to provide every U.S. adult with a bottleful. They also ignore the role of prescribing patterns on chronic opioid use.

Many experts believe that a three-pronged approach involving opioid addiction prevention and treatment—as well as pain pill supply control—is needed.

Efforts on the local, state, and national levels are currently underway that could finally produce a breakthrough in the crisis. They include lawsuits against prescription opioid manufacturers and distributors, a special opioid commission created by President Donald Trump, a congressional investigation, and new state laws.

The Challenges of Opioid Litigation

Lawsuits against opioid manufacturers such as Purdue Pharma (maker of OxyContin) have been an uphill battle.

The U.S. opioids market is expected to reach $17.7 billion by 2021.

Big Pharma’s deep pockets and cozy relationship with government make it a powerful adversary. The U.S. market for opioids is worth more than $11 billion and is expected to reach $17.7 billion by 2021. Opioid makers’ huge profits have allowed them to stack the regulatory deck in their favor and hire high-powered legal teams that include former government insiders.

And even though the actions of opioid makers seem indefensible, pharmaceutical companies have successfully invoked sound legal defenses in many of cases they’ve faced. The stigma surrounding opioid addiction is yet another factor working in drugmakers’ favor.

Individual Lawsuits

Arguing before the Philadelphia Court of Common Pleas in February, Judge Frederica Massiah-Jackson told an attorney (who was trying to convince her that the opioid industry was responsible for his client’s overdose death), “I’m not as sympathetic to this whole opiate thing. When it was cocaine and heroin there wasn’t all of this.”

Judge Massiah-Jackson added, “Find some legal arguments for me.”

Unfortunately, the legal arguments often favor opioid manufacturers. A review of cases against Purdue Pharma published in the West Virginia Law Review found that Purdue won most individual plaintiff lawsuits at the summary judgment level by claiming lack of causation, misuse, wrongful conduct, or expiration of the statute of limitations.

Product liability law is the typical recourse for pharmaceutical-related harm. But arguments that OxyContin and other opioid medications are defectively manufactured, defectively designed, or defectively marketed are a tough sell.

Manufacturing defect means that the product is not made to specification. While such opioid cases have succeeded, they’re usually limited to a particular opioid product or batch that doesn’t work the way it’s supposed to.

Design defect claims—in particular, arguments related to higher strength opioid pills having an excessive drug dose, lack of antagonistic (euphoria-suppressing) formulations, and the ability of users to bypass time-release mechanisms (by, for example, crushing the drugs and snorting or injecting them)—are more feasible. However, when opioid patients misuse or alter the drugs, which commonly occurs among patients who’ve become opioid addicts, manufacturers can use patients’ behavior as a defense.

Failure to warn claims have been mostly unsuccessful because many opioid pill inserts warn about the drugs’ potential toxicity, addictiveness, and potential for abuse. In addition, the “learned intermediary” doctrine followed in many states—whereby the physician serves as the gatekeeper between drugmaker and patient—breaks the chain of causation and provides legal cover for manufacturers.

Drugmakers’ aggressive marketing allowed them to alter prescribing patterns and turn drugs like OxyContin into blockbusters.

Also instrumental to opioid makers’ legal successes is that they’ve done relatively little direct-to-consumer advertising, instead targeting physicians in an attempt to alter their prescribing habits. Purdue, in fact, engaged in no direct-to-consumer advertising. This strengthens the physician’s role as a learned intermediary and shields drugmakers from failure to warn and other marketing claims.

But while manufacturers’ aggressive (and, many argue, false and misleading) marketing allowed them to fundamentally alter opioid prescribing patterns and turn drugs like OxyContin into blockbusters, their tactics have produced legal consequences.

Opioid Class Actions

Class action lawsuits brought by opioid users against drug companies remain a possibility, but they too have failed to gain traction.

Class action lawsuits must receive certification before they can proceed. Certification is based on several requirements; failure to meet any of the requirements results in the case not being certified.

Perhaps most troublesome has been the “commonality” requirement that says there must be a legal or factual question common to all class members. Courts have supported drugmakers’ assertion that questions regarding class members’ medical histories, the factual circumstances of their addiction, and whether drug companies misrepresented opioids or inappropriately promoted them could only be determined on an individual—not a class-wide—basis.

State Lawsuits

Government legal action against opioid manufacturers has been much more successful than individual and class action lawsuits, although some of the settlements reached are seen as disappointments.

Parens patriae lawsuits—cases in which the state asserts its standing to sue to protect its “quasi-sovereign” interests, such as its interests in the wellbeing of its residents—have effectively allowed state officials to bypass the individual claims requirements that have hampered other lawsuits by naming the state itself as the injured party and seeking damages that can replenish welfare, healthcare, justice, and other social systems stressed by rampant opioid addiction.

Kentucky settled with Purdue Pharma in 2015 for $24 million.

Liability theories also differ in parens patriae cases. For example, they often include public nuisance claims. Public nuisance laws were originally designed to allow the demolition of run-down buildings that threatened the community’s safety.

The state of West Virginia and Pike County, Kentucky settled parens patriae cases with Purdue Pharma for $10 million (2004) and $4 million (2013), respectively. Pike County used the settlement money to expand a drug rehabilitation facility.

Non-parens patriae state lawsuits have made inroads against opioid makers as well.

In 2007, Purdue Pharma settled with 26 states and the District of Columbia for $20 million for unlawfully marketing OxyContin. The multi-state class action lawsuit was inspired by the West Virginia settlement and alleged that Purdue misbranded OxyContin as “less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”

While a $20 million settlement might seem like a big win, an assistant attorney general in the case expressed “tremendous buyer’s remorse” that the case did not settle for more money or lead to substantive changes in opioid prescribing patterns. Indeed, the opioid epidemic has only deepened over the last decade.

Kentucky refused a $500,000 offer in the case, fought for more money, and in 2015 settled with Purdue for $24 million. Former Kentucky Attorney General Greg Stumbo, who filed the 2007 lawsuit, believes the case could be worth $1 billion if it ever reached a jury. But accepting the settlement suggests that the Attorney General’s lawyers had doubts about a win at trial.

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How Americans Pay the Price for Drug Advertising

The U.S. is only one of two countries in the world that allows direct-to-consumer drug advertising, and we may be paying a heavy price for it.

It’s difficult to watch television without hearing “ask your doctor” blaring from the latest pharmaceutical commercial.

In 2016, direct-to-consumer drug advertising was the sixth largest advertising category in the U.S.

Yet, these commercials that are so commonplace in the U.S.—80 air every hour, according to Nielsen—are a unique phenomenon. In fact, the only other country where direct-to-consumer drug advertising is legal is New Zealand.

In 2016, direct-to-consumer drug advertising was the sixth largest advertising category in the U.S., and it continues to grow.

Now, leading groups like the American Medical Association are calling for a ban on consumer drug advertising, voicing what many Americans are already thinking. In a poll conducted by STAT and Harvard School of Public Health last year, 57% of respondents said they supported a ban on drug commercials.

These commercials do more than just take up advertising air space. Big Pharma’s billion-dollar advertising budget can cause a host of problems, including high drug costs and adverse drug events.

The Evolution of Big Pharma Advertising

The following events were pivotal in shaping Big Pharma into the advertising giant that it is today.

1969: FDA Allows Direct-to-Consumer Advertising

The FDA permits consumer advertising to encourage price competition. Advertisements must include a brief summary of every known health risk of the medication. This requirement makes print the only feasible option for advertising since the health risks can be spread across multiple pages.

1983: FDA Pulls First Pharmaceutical Drug Commercial 

Boots Pharmaceuticals runs the first commercial for their ibuprofen, rufen. The company only advertises the price of the medication, believing that if it doesn’t make any medical claims, it doesn’t have to share the risks. But within 48 hours, the FDA orders them to pull the commercial.

1996: Claritin Finds a Loophole

A Claritin commercial exploits a regulations loophole by not specifying what the medication is for, instead telling viewers to ask their doctors for details. By doing so, they don’t have to list the drug’s risks.

1997: FDA Trims Advertising Regulations

Pressured by lobbyists and politicians, the FDA loosens advertising regulations by only requiring companies to share a medication’s major health risks in advertisements. Companies can now direct consumers to another source (a phone number, website, etc.) for more information.

Drug Advertising Encourages Pricey Prescriptions

Nine out of ten pharmaceutical companies spend more money on advertising than they do on research and development.

From 2012 to 2016, spending on pharmaceutical drug advertisements increased by 62%—more than any other ad category over that time. In 2016, drug companies spent more than $6 billion on advertising

This huge sum ultimately costs patients and impedes medical advances. Nine out of ten pharmaceutical companies spend more money on advertising than they do on research and development.

Though companies have to disclose the major risks in their ads, they don’t have to share data on the effectiveness of the medication or whether or not it is superior to a generic version. Drug companies heavily advertise their premium medications, often leading Americans to ask their doctors for expensive medications over generic versions.

“Looking at all the evidence about direct-to-consumer advertising, any reasonable person would support a ban on this dangerous form of marketing.”

According to the FDA, generic medications cost 80 to 85% less than premium versions, and they meet the same safety and effectiveness standards set by the FDA.

The American Medical Association (AMA) noted this discrepancy when they asked for a complete ban on direct-to-consumer drug advertising in 2015. The AMA said that direct-to-consumer advertising “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

We asked Dr. Ray Moynihan, Senior Research Fellow at Bond University and author of Selling Sickness, for his thoughts on banning drug advertisements altogether.

“Looking at all the evidence about direct-to-consumer advertising, any reasonable person—acting independently of the pharmaceutical industry influence—would support a ban on this dangerous form of marketing. [This] would inevitably bring improvements in health and health system sustainability,” Dr. Moynihan said.

Drug Advertisements Understate Side Effects

In an FDA study, participants were less likely to remember the drug risks listed in a commercial if they were played alongside distracting visuals or music.

Drug companies are required to list the side effects of their medications in commercials, but whether or not viewers can remember that information is another story. There are no restrictions against using visuals, music, and other design elements to understate harmful risks.

In 2016, the FDA conducted a study on viewer distraction during drug commercials. The agency discovered that viewers were less likely to remember the drug risks if they were played alongside distracting visuals or music. Instead, what viewers often remember are the images of happy and healthy people and the drug’s benefits.

In 2008, the FDA accused popular birth control YAZ of downplaying the risks of the contraceptive in their commercials. YAZ patients, the FDA reported, had a 74% increased risk of blood clots compared with patients on other oral contraceptives. The company was also accused of overstating the contraceptive’s benefits by claiming it could help other conditions like acne.

The FDA sent YAZ manufacturer Bayer a warning letter in 2008 that said:

The[se] complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed… The overall effect … is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.

As part of a $20 million settlement with the FDA, Bayer aired a follow-up commercial that clarified the contraceptive was not approved for moderate acne or premenstrual syndrome.


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How Does the FDA Approve New Drugs?

During his first address to a joint session of Congress, President Donald Trump vowed to “slash the restraints” on the “slow and burdensome approval process” at the U.S. Food and Drug Administration (FDA) that “keeps too many advances… from reaching those in need.”

Mr. Trump did not provide concrete reform proposals, but his comments echoed those he made about the agency on the campaign trail and are consistent with conservatives’ desire to slash what they see as excessive FDA red tape.

Mr. Trump’s posture suggests a significant shakeup of the FDA.

While many were quick to point out that the FDA not only approves new drugs about as fast as any regulatory agency in the world, but has also in recent years streamlined how it approves many new drugs. But focusing only on the “approval process,” while leaving out a discussion of clinical drug development—which can take 12 years or more—paints an incomplete pictur

FDA critics claim that the agency as it currently operates is not flexible enough to efficiently oversee a world of accelerating medical advancements and personalized medicine. Some have proposed, among other measures, a market-based solution that they argue would break the FDA’s monopoly on drug access and make new drugs available up to seven years earlier than they are at present.

The FDA’s future under President Trump should gain clarity when he finally announces his pick to lead the agency. However, Mr. Trump’s leading FDA chief candidates and his early comments to the pharmaceutical industry suggest significant FDA reforms.

How a New Drug Gets Approved

Before addressing FDA modernization, it’s important to understand the journey new drugs take from the laboratory to pharmacy shelves.

FDA approval is the final phase of a larger process known as the “new drug development process.” Although the FDA does not conduct its own new drug testing (this would be prohibitively expensive), it is actively engaged in all phases of the new drug development process.

For example, the FDA determines what evidence is needed to prove that a new drug is safe and effective, approves and monitors clinical trials, and at the end of the process, evaluates a company’s New Drug Application (NDA). A drug cannot be marketed to the public until the FDA approves its NDA.

This entire process takes an average of 12 years. Here’s how it breaks down:

  • Preclinical research: New drug research starts in the lab. Researchers identify a compound they believe has a clinical effect on a specific disease and then test it on cell cultures and eventually, on living animals. If lab results justify further testing on human subjects—a determination the FDA makes based on a lengthy application—the drug proceeds to clinical trials. The preclinical research phase can take up to 3.5 years.
  • Phase I trials: The first stage of clinical trials, Phase I studies involve 20-100 people with the disease/condition the drug intends to treat. Meant to establish the drug’s basic properties and human safety, Phase 1 studies last 1-2 years. About 70% of drugs clear this stage.
  • Phase II trials: Phase II clinical trials ascertain a drug’s efficacy and side effects. They use several hundred people with the disease being studied and take several months to 2 years. Approximately two-thirds of drugs move on to phase III trials.
  • Phase III trials: Phase III clinical trials are typically the most extensive and expensive phase of drug development. This phase involves testing the drug on 300-3,000 patients to confirm safety, effectiveness, and dosing. These trials take 2-4 years. About 10% of medicines fail in phase III trials.
  • New Drug Application: A drug that successfully completes all three clinical trial phases is eligible for a New Drug Application (NDA) with the FDA. It usually takes 1-2 years between the completion of a phase III trial and drug approval, including 6-10 months for the NDA review.

If the FDA approves the drug, physicians may then prescribe it to patients. In some cases, including Xarelto, the FDA orders phase IV (“post-marketing”) studies to evaluate long-term safety and efficacy.

Only one out of every 5,000-10,000 compounds that begin in preclinical testing is approved for marketing.

Expedited Drug Approval Programs

The multi-stage drug development and review process is intended to keep unsafe and/or ineffective drugs from reaching the public. However, because it takes so long, the process can be problematic for patients who have conditions that currently lack good treatment options.

This issue came to the fore during the AIDS crisis of the 1980s and 1990s, spawning FDA programs that expedite the approval of new therapies intended to treat unmet medical needs.

  • Orphan drug: The 1983 Organ Drug Act incentivizes new drugs that treat diseases affecting fewer than 200,000 patients per year by creating tax breaks and market exclusivity periods. Orphan drugs are often approved on the basis of less-rigorous clinical trials.
  • Fast track: The FDA’s “fast track” approval designation of 1988 allows drugs that treat life-threatening or debilitating diseases to be approved after a single phase II clinical study.
  • Accelerated approval: Implemented in 1992, the FDA’s “accelerated approval” pathway alters evidentiary standards for drugs that treat serious or life-threatening diseases.
  • Priority review: In 1992 the FDA formalized a 1975 program guaranteeing FDA review within six months of drugs offering a therapeutic advance over available treatment.
  • Breakthrough therapy: Since 2012, the FDA may designate a new drug a “breakthrough therapy” if it treats a serious or life-threatening disease and demonstrates substantial improvement over existing therapies. Designated breakthroughs receive expedited development and review.

Source: BMJ

How effective have these programs been at bringing new drugs to needy patients? A 2015 BMJ study suggests the programs aren’t exactly being used as they’re intended.

BMJ looked at nearly 800 drugs approved by the FDA through expedited development and review pathways between 1997 and 2014. It found that, “over time… a greater proportion of programs were being applied to drugs that were not the first in their class. Such drugs are more likely to be only incrementally innovative and many not represent a clinical advance.”

While such drugs may still have value, using the expedited programs for less innovative products can divert limited FDA resources, says BMJ.

How Trump Could Shake Up the FDA

Megan Crowley, a guest of first lady Melania Trump at the president’s congressional address, was held up as a “miracle” of drug innovation.

Megan is a 20-year-old college student who suffers from Pompe disease, a potentially fatal neuromuscular disease. She was not expected to live past age five, but her father founded a medical company that developed the enzyme replacement drug which helped save Megan’s life.

The drug, Myozyme, was approved in 2006 based on trials featuring only a few dozen patients and an expedited review.

“If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan,” said Mr. Trump.

His comments to Congress on the FDA were very similar to those he made on the campaign trail, where he said he wanted to “speed the approval of life-saving medications” and mentioned “cutting the red tape at the FDA.”

When he spoke with pharmaceutical CEOs in January, the president mentioned eliminating 75-80 percent of all FDA regulations.

“We’re going to get the approval process much faster,” Mr. Trump told the pharma heads.

“Right to Try” Law

Mr. Trump has also signaled support for a national “right to try” law giving terminally ill patients the right to take drugs that are still in development. Thirty-three states have right-to-try laws on the books, and the FDA has a similar “compassionate use” program.

The FDA has denied only 39 of the 7,291 compassionate use requests made by physicians since 2009, making a national right-to-try law somewhat redundant, but it cannot make companies comply with physician requests for experimental drug access for their terminal patients. A national right-to-try law in theory could compel pharmaceutical and insurance companies to provide and pay for experimental drugs.

Reciprocal Approval

Another FDA reform President Trump could champion is “reciprocal approval” legislation, or a law that would allow new drugs approved in other countries with drug safety standards similar to the U.S. to be sold stateside.

On the campaign trail Mr. Trump said he would “remove barriers to entry” of “imported and safe dependable drugs from overseas.”

While reciprocal legislation might help fill drug gaps and lower drug prices by introducing greater competition, a BMJ study concluded that the legislation “would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms.”

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