Victims Look for Answers as Opioid Epidemic Sweeps America

A drug overdose epidemic is sweeping America, led by a dramatic surge in deaths from opioids—a powerful, highly-addictive class of drugs that includes natural and synthetic analgesics such as morphine, oxycodone, hydrocodone, methadone, and fentanyl, as well as heroin.

Those responsible for America’s opioid epidemic have largely escaped legal consequences, but people from the hardest-hit states are starting to fight back.

Heroin is the product of an underground drug trade pushed in back alley deals. Prescription opioids are shipped from warehouses, prescribed in doctor’s offices, and picked up at pharmacies.

One drug cartel operates on the black market, the other in white lab coats. But their products are nearly identical, both in their chemical composition and their ability to destroy lives.

Indeed, a patient who begins a painkiller regimen at a clinic very often ends up buying drugs on the street. And all too often, that same patient ends up dead.

Protected by powerful interests, those responsible for America’s opioid epidemic have largely escaped legal consequences. People from the hardest-hit states, however, are beginning to fight back.

Fight Back

Prescribing Trends Drive Overdoses

Last year the U.S. death rate increased for the first time in a decade, and overall life expectancy dropped for the first time since 1993.

Since 1999, the number of prescription opioids sold has almost quadrupled.

These sobering statistics coincide with 33,091 deaths from illegal and legal opioids in 2015—an increase of more than 200% since 2000—including more than 15,000 from overdoses involving prescription opioids.

More than six out of ten overdose deaths involve an opioid. Every day, 91 Americans die from an opioid overdose. Nearly half of all opioid deaths involve a prescription opioid.

Heroin overdose deaths, which have more than tripled in the past four years, are closely correlated with prescription opioids. The CDC reports that past prescription opioids misuse is the strongest risk factor for heroin use. Four out of five heroin addicts were initially addicted to prescription opioids.

Image source: CDC
Image source: CDC

Since 1999, the amount of prescription opioids sold has almost quadrupled. Over the same period, prescription opioid deaths have more than quadrupled.

But the amount of pain Americans report has not changed. There is also a lack of evidence to support opioids’ long-term effectiveness for managing chronic pain.

In fact, a 2016 University of Colorado study found that opioids actually increase chronic pain.

This could help explain why prescription opioid users frequently require higher medication doses to achieve the same pain relief. Higher opioid doses make it more likely that a patient will become addicted.

As the dose increases, so does the overdose risk. Overdosing on opioids can stop a person’s breathing, causing permanent brain damage or death.

Drug Companies Capitalize on Expanded Indications

Before the 1980s, prescription opioids were primarily prescribed for short-term pain and chronic pain associated with cancer and the end of life.

The medical community’s fundamental rethinking of pain in the mid-80s—from a symptom that should be tolerated to a vital sign that doctors could measure and treat—paved the way for prescription narcotics’ emergence.

Drug companies, seizing on expanded pain pill uses, began introducing new drugs and aggressively marketing them.

One company in particular, Purdue Pharma, maker of OxyContin, exemplified the industry’s focus on chronic non-cancer pain.

OxyContin was approved in 1995. From 1996 to 2002, OxyContin sales increased from 300,000 prescriptions ($44 million) to 7.2 million prescriptions ($1.5 billion). Over this period the number of Purdue sales representatives more than doubled.

In 2001 alone, Purdue spent $200 million on OxyContin marketing. Sales representatives received six-figure bonuses.

In 2001 alone, Purdue spent $200 million on OxyContin marketing.

High-prescribing doctors were compiled in a company database and targeted. Branded promotional materials—including hats, plush toys, coffee mugs, and coupons for free OxyContin prescriptions—were distributed to practitioners.

Purdue also conducted “pain conferences” where physicians gave paid speeches and targeted doctors with medical journal advertisements.

But the marketing frenzy was based on a fundamental lie. Purdue claimed that OxyContin’s patented time-release formula posed an addiction risk of less than 1 percent. Sales reps told some doctors that the drug didn’t even cause a buzz. Meanwhile, Purdue rolled out stronger pills with even higher addiction and abuse risks.

In this way, a supposedly non-addictive, heroin-like drug was prescribed to millions of patients who in years past would have been given an over-the-counter drug.

Distributors, Doctors, and Pharmacies Get in on the Game

Drug companies like Purdue Pharma bear outsize blame for America’s opioid epidemic, but they’re not the only ones responsible for flooding communities with narcotic pain pills.

West Virginia—one of the states hit hardest by the epidemic—shows a multi-pronged conspiracy.

Over six years, according to the Charleston Gazette-Mail, 1,728 West Virginians suffered fatal opioid overdoses as drug wholesalers poured 780 million hydrocodone and oxycodone pills into the state—an amount equal to 433 pain pills per resident.

Image source: CDC
Image source: CDC

Just three wholesalers supplied more than half of the pills. The companies have total revenues exceeding $400 billion. Their top executives pulled in more than $450 in compensation over the past four years as the West Virginia opioid death toll climbed.

The middlemen, however, had help from pharmacies and doctors.

For example, the Gazette-Mail reports that some small, independent drugstores and pharmacies ordered 1.1 million to 4.7 million opioid pills per year.

A report in The Guardian describes one “pill mill” pharmacy in Williamson, West Virginia that filled up to 200 opioid prescriptions per day.

Some doctors and clinics are willing pill mill accomplices.

Opioid-addicted patients, many of whom get hooked after an initial prescription for pain, “doctor shop” among numerous providers. Some doctors and clinics, however, are willing pill mill accomplices.

One Williamson clinic with a reputation for no-questions-asked prescriptions made $4.5 million per year. The doctors—including a Pennsylvania physician who sent blank, pre-signed prescriptions to the clinic—often did not even see the patients for whom they were prescribing pills.

Lawsuits Seek Accountability

In 2006, as the opioid epidemic gained attention, the Drug Enforcement Agency (DEA) began cracking down on the drug distribution chain.

A groundbreaking West Virginia lawsuit seeks damages from doctors, pharmacies, and distributors that formed a “veritable rogue’s gallery of pill-pushing.”

Civil cases against manufacturers, distributors, pharmacies, and doctors reached 131 in 2011 but dropped to 40 in 2014, reports The Washington Post.

The reason for the decline was industry pushback. Drug companies hired former DEA and Justice Department officials to lobby against industry prosecution. Soon after, DEA officials began delaying and blocking enforcement actions.

At the state level as well, drug-makers have blocked measures aimed at curbing prescription opioid distribution. Using lobbyists and campaign contributions, drug companies have outspent anti-opioid activists by more than 200 times, according to the Associated Press.

The state of New Hampshire, which had the third highest rate of drug overdose deaths in 2014, has filed subpoenas against drug companies seeking information about how prescription painkiller are marketed in the state. The state has three attorneys on the case. The pharmaceutical companies have 19. So far, the investigation hasn’t produced a single document.

But not all legal efforts against the prescription opioid racket have fallen flat.

In 2007, Purdue Pharma pleaded guilty to misleading doctors and patients about the addictive potential of OxyContin and misbranding the drug as “abuse resistant.” And in 2015, after a nine-year legal battle, Purdue agreed to a $24 million settlement with the state of Kentucky for alleged Medicaid fraud involving OxyContin.

A groundbreaking West Virginia lawsuit filed by 29 plaintiffs who survived opioid addiction or lost a loved one to painkiller addiction seeks damages from doctors, pharmacies, and distributors that formed a “veritable rogue’s gallery of pill-pushing.”

West Virginia’s highest court rejected claims by the defense that admitted drug abusers should not be able to sue, citing the legal principle of comparative fault.

“What is it going to take before we as a nation accept that we are the victims for the most part and the doctor, the pharmacist and pharmacies are the perpetrators feeding off the lives of others?” said plaintiff and former opioid addict Wilbert Hatcher.

America’s opioid epidemic is an unprecedented public health crisis. Holding the responsible parties accountable may just require unprecedented litigation.

Invokana Lawsuits Consolidated into New Jersey MDL

A federal judicial panel has centralized more than 50 Invokana lawsuits in New Jersey federal court.

The lawsuits claim that Invokana can cause ketoacidosis and other injuries.

The lawsuits claim that diabetes medications Invokana and Invokamet cause ketoacidosis, kidney damage, and other injuries.

More cases are expected in the multidistrict litigation (MDL) over Johnson & Johnson’s blockbuster drug, which was recently revealed as a top-spending brand on doctor payments.

Hold J&J Accountable

Judges Grant Centralization, Citing Commonality

Plaintiffs alleging harm from Invokana and Invokamet in September requested that the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidate 55 individual lawsuits in Jew Jersey federal court, citing enhanced efficiency.

On December 7 the JMPL agreed and issued an order transferring lawsuits from California, Georgia, Illinois, Kentucky, Louisiana, and Minnesota to the District of New Jersey under Judge Brian R. Martinotti.

“We find that the Invokana/Invokamet actions involve common questions of fact, and that centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the Panel wrote. “The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage.”

Plaintiffs claimed in their consolidation request that J&J knew about kidney damage and ketoacidosis caused by Invokana/Invokamet, but did not warn patients while continuing to promote the drug. Plaintiffs also allege that Invokana and Invokamet are defectively designed and were not adequately tested.

Multidistrict litigation centralizes similar cases for pretrial proceedings, making it easier for lawyers to coordinate their activities. Individual cases are tried in the jurisdictions where they were originally filed.

Several MDL cases, known as bellwether cases, are typically singled out and tried first.

The Panel says it is aware of 44 additional related federal lawsuits.

New—but Not Necessarily Improved—Diabetes Drug

Invokana (canagliflozin) was approved in 2013 to treat Type 2 diabetes. It belongs to a new class of diabetic drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana works differently than older diabetes drugs, and poses new risks.

Invokana works differently than older diabetes drugs, and poses new risks.

Diabetic patients do not produce enough insulin, causing dangerous blood sugar spikes that damage the body over time.

Older diabetes drugs increase insulin levels, but SGLT2 inhibitors are different. They reduce the amount of blood sugar the kidneys reabsorb into the body by expelling some sugar through urination.

This mechanism of action is associated with an increased risk of acute kidney damage. The FDA strengthened existing kidney damage warnings for Invokana and other SGLT2 inhibitors in June 2016, but some say this was too little, too late.

Invokana is also linked to potentially-fatal excessive blood acids (ketoacidosis), increased bone fracture risk, cardiovascular side effects, and amputations.

J&J Spent Millions on Invokana Doctor Payments

In 2015, Invokana’s second full year on the market, sales surged 123% to $1.3 billion.

That same year, public records show, J&J spent $20.9 million promoting Invokana to physicians. Only two brands—Xarelto and Humira—were associated with higher doctor spending. Other top-spending brands for 2015 were Viekira, Eliquis, and Androgel.

These figures come from ProPublica’s Dollars for Docs, which is based on disclosures required under the Physicians Payments Sunshine Act, part of the 2010 Affordable Care Act.

Included in the payments data is money for speaking, consulting, meals, travel, gifts, and royalties. Although doctors who receive drug company money are not formally obligated to prescribe certain products, research shows that doctors receiving payments tend to prescribe more brand-name drugs than those not receiving payments.

Invokana spending reflects increased SGLT2 competition in a growing diabetes treatment market.

Contact us to report an Invokana complication and learn your legal rights.

FDA Chief’s Conflicts of Interest and the “Revolving Door” Problem

When a government official holds or has held a professional position in the same industry that he or she is charged with regulating, it raises questions about whether public or private interests are being served.

The “revolving door” between the public and private sectors is a major impediment to responsible democratic governance.

The current U.S. Food and Drug Administration (FDA) commissioner, Dr. Robert M. Califf, has extensive pharmaceutical industry ties and has been accused of undermining public health and safety.

With President-elect Donald Trump set to choose a new FDA chief, ClassAction.com looks at how an official’s non-government experience can muddy the regulatory waters.

What Is the Revolving Door?

The revolving door refers to the practice of switching back and forth between public and private employment.

This phenomenon is commonly observed among members of Congress who leave the federal government and become lobbyists, although it can occur whenever someone with government experience gains employment in a private sector job where they can influence public policy decisions, or vice versa.

Lobbying’s return on investment bears out its effectiveness.

Although generally seen as negative, the revolving door has a practical upside. Namely, corporate experience gives regulators and policymakers a deeper understanding of complex issues that, in a capitalist system, cannot be divorced entirely from private interests.

However, the opposite also holds true: once a public official leaves office, he or she can leverage knowledge about the workings of government into lucrative private sector compensation.

Lobbying’s return on investment bears out its effectiveness. Research conducted by the Sunlight Foundation found that from 2007-2012, 200 corporations spent $5.8 billion on federal lobbying and campaign contributions and got back $4.4 trillion in federal business and support.

In other words, for every dollar these corporations spent on influencing politics, they received $760 from the government.

Lobbying-ROI-1024x461
Credit: UnitedRepublic.org/Represent.us

Robert Califf, Big Pharma, and the FDA

Current FDA commissioner Robert Califf, a cardiologist and clinical researcher tapped by President Obama to run the nation’s drug regulatory agency, was criticized at the time of his nomination for his drug company connections.

The New York Times reported that Dr. Califf “has deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.”

Dr. Califf’s disclosed industry ties include financial support from Johnson & Johnson, Lilly, Merck, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Medtronic, and Bayer. He also has financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche, Genetech, Medscape LLC, Portola Pharmaceuticals, and other companies.

Dr. Califf first joined the FDA as deputy commissioner for medical products and tobacco. Before his government tenure, he ran a multimillion-dollar clinical research center at Duke University that was a major contractor to the pharmaceutical industry. The center was more than 60% industry-funded.

Califf Ran Troubled Xarelto Trial

While at Duke, Johnson & Johnson paid Dr. Califf to conduct an important clinical study of the blood-thinner Xarelto. That study was criticized for being biased in the drug’s favor.

Although the FDA approved the anticoagulant Xarelto, FDA scientists expressed misgivings about its safety and effectiveness, warning that it could pose greater stroke and/or bleeding risks than its predecessor, warfarin.

Xarelto is a blockbuster drug for Johnson & Johnson but it has also been the target of thousands of lawsuits alleging the drug caused serious bleeding events and deaths. Unlike warfarin, Xarelto does not have an antidote to stop internal bleeding.

Some Question Califf’s Involvement in 21st Century Cures Act

Congress recently passed the 21st Century Cures Act, a sweeping health bill some say is too friendly to drug and device companies.

“It should be unimaginable that the most senior [FDA] officials would collude with the lead medical device trade association.”

Leading the legislation’s criticism was Ralph Nader’s Public Citizen. In 2015, when an earlier version of the bill was being considered and Dr. Califf was awaiting confirmation as FDA chief, Public Citizen criticized him for participating in at least one high-level strategy meeting with the industry about the bill.

“It should be unimaginable that the most senior Food and Drug Administration officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened,” said Public Citizen’s Dr. Michael Carmone in a statement.

New Nomination, New Questions

The incoming Trump administration hasn’t officially nominated an FDA commissioner, but rumored picks are drawing scrutiny.

Leading candidates to run Trump’s FDA include Jim O’Neill and Dr. Scott Gottlieb.

Potential nominee Jim O’Neill, a self-described libertarian, served as principal associate secretary of health and human services under George W. Bush and is a managing director at Peter Thiel’s Mithril Capital Management.

While Mr. O’Neill doesn’t have a medical background, perhaps more worrying is his endorsement of what he calls “progressive approval,” which would allow drugs proven safe—but not necessarily effective—by the FDA to be marketed.

Another potential Trump FDA pick, Dr. Scott Gottlieb, has medical credentials as well as government experience, having served as a senior adviser to the FDA commissioner in 2003-2004, senior adviser to the Centers for Medicare and Medicaid Services in 2004, and FDA deputy commissioner for medical and scientific affairs from 2005-2007. But Dr. Gottlieb also has deep pharmaceutical industry ties, reports Reuters.

Trump’s eventual nominee requires Senate approval. But despite a divided government, the revolving door between government and industry has bipartisan support: after all, Robert Califf was confirmed in an 89-4 vote.

House Approves Controversial 21st Century Cures Act

The 21st Century Cures Act—a nearly 1,000-page omnibus healthcare spending bill—has been approved by the House and is now under Senate review.

Supporters say the bipartisan bill will accelerate medicinal and medical device innovation. Detractors claim it makes industry concessions that weaken regulatory oversight and undermine public health.

If Senators approve the legislation as expected, President Obama could sign it into law before the end of the year.

Act Will Streamline FDA Approval Process

A lot is covered in the sprawling, 996-page bill, from foster care to mental health to stem-cell therapies and Medicare.

Changes primarily revolve around the National Institutes of Health (NIH), which provides federal funding for healthcare research, and the Food and Drug Administration, the agency responsible for pharmaceutical and medical device safety and efficacy.

Major provisions include:

  • Increased NIH funding: NIH will receive $4.8 billion in new funding over ten years, including money for brain, cancer, and precision medicine research, as well as $1 billion for the nation’s opioid crisis. A top priority is Vice President Biden’s “Cancer Moonshot,” a plan that aims to accomplish 10 years of cancer research in half the time. Additional support for young emerging scientists would be created through a loan repayment program.
  • Faster action on new drugs and devices: The FDA has been criticized for a slow approval process that prevents faster adoption of healthcare breakthroughs. Proposals in the 21st Century Act aim to streamline the drug and device approval process. Specific initiatives include an accelerated approval pathway for regenerative medicines, using “real world evidence” (such as observational studies and registries) to support new indications for approved drugs, and broader categorization of “breakthrough” devices.

The bill also places new requirements on the Centers for Disease Control and Prevention (to expand neurological disease surveillance) and the Department of Health and Human Services (to revise health information privacy rules).

“A Grab Bag of Goodies for Big Pharma”?

Critics have voiced concerns about what’s in the legislation, as well as what’s not in it.

“The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific breakthroughs for America.”

Public Citizen says the Senate should reject 21st Century Cures, calling it a corporate giveaway disguised as reform.

“The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific breakthroughs for America. But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical devices companies that would undermine requirements for ensuring safe and effective drugs and medical devices,” said Public Citizen’s Dr. Michael Carmone in a statement.

Public Citizen further notes the new NIH money must be reauthorized each year, making its programs non-guaranteed.

A letter to Congressional leaders from Public Citizen and a dozen other organizations singles out the legislation’s failure to relieve high prescription drug costs.

“There is no justification for moving forward with legislation that provides substantial benefits to the drug industry without asking for something in return,” the letter states.

Critics blame what they consider already-lax FDA oversight for failed medical devices such as the Essure permanent birth control. Essure received fast-track FDA approval in 2002 and has since been linked to thousands of injuries, several deaths, and an unacceptably high pregnancy rate. As a result, the FDA recently slapped Essure with a black box warning.

1,500 Lobbyists Fought for the Act

The 21st Century Cures Act passed the House last year but died in the Senate. Republican lawmakers unveiled a revised version during the Thanksgiving holiday weekend and it passed 392-26 during the lame-duck session.

Now under Senate consideration, the Act enjoys bipartisan support but has drawn disparate comments along partisan lines.

“It really is a David and Goliath issue of where the money is.”

Senate Majority Leader Mitch McConnell (R-KY) called the bill “the most important legislation Congress will consider this year.”

Elizabeth Warren (D-MA) said, “I cannot vote for this bill,” and described the Act as “a tiny fig leaf” covering “huge giveaways to giant drug companies.”

So who actually benefits from the 21st Century Act? The money trail provides answers.

According to Kaiser Health News, nearly 1,500 lobbyists representing 400 organizations petitioned Congress regarding the Act. That’s the fourth-most lobbying activity for any bill this congressional cycle.

Major lobbying efforts were made by:

  • Pharmaceutical, device, and biotech companies: $192 million
  • Medical schools, hospitals, and doctors: $120 million
  • Chamber of Commerce: $87.1 million
  • Health information technology and software companies: $35 million
  • Patient groups (funded by drug and device companies): $6.4 million
  • Mental health, psychology, and psychiatry groups: $1.8 million

In contrast, opposition generally comes from nonprofit patient advocacy and research groups.

“It really is a David and Goliath issue of where the money is,” said Diana Zuckerman of the nonprofit National Center for Health Research, which is running a campaign against the bill.

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