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.

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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.

Help hold drug and device companies accountable. Report problems to ClassAction.com.

FDA Approves New Power Morcellator Despite Cancer Risks

The U.S. Food and Drug Administration (FDA) has approved a new surgical tool used in minimally invasive gynecological procedures months after it discouraged use of the device over cancer concerns.

Power morcellation has been shown to spread undetected cancer in patients.

Olympus America Inc.’s Contained Tissue Extraction System, a type of laparoscopic power morcellator, was cleared through FDA’s controversial 510(k) program, which requires no testing on human subjects.

Olympus received clearance from the FDA on November 16 for the company’s next-generation laparoscopic PK Morcellator, even though power morcellation has been shown to spread undetected cancer in patients.

Power Morcellation Can Spread Cancerous Tissue

Laparoscopic power morcellation is a surgical procedure for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy). During the procedure, a power morcellator–a device resembling a handheld drill–is inserted through a small incision. It then grinds up tissue into small pieces for removal.

Hysterectomies and myomectomies via power morcellation are associated with fewer complications than the same procedures performed via surgical incision into the abdominal cavity.

But there’s a catch: power morcellation has been shown to spread undetected cancer (uterine sarcoma) in patients. This has led to hundreds of lawsuits filed by affected patients.

Most women will develop uterine fibroids at some point in their lives. While many fibroids are benign, approximately 1 in 350 women have unsuspected uterine sarcoma hidden within fibroids. Power morcellation has the potential to disperse cancerous tissue beyond the uterus, substantially worsening the patient’s long-term survival outlook.

FDA Discourages Power Morcellation for Hysterectomies

In April 2014, the FDA issued a safety communication discouraging use of laparoscopic power morcellation for removal of the uterus or uterine fibroids.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said Chief Scientist William Maisel. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Since the safety communication was issued, rates of power morcellation use for hysterectomy and myomectomy have decreased significantly.

According to a study in the Journal of the American Medical Association (JAMA), the percentage of women undergoing hysterectomy via power morcellation decreased from 13.7% in the fourth quarter of 2013 to 2.8% in the first quarter of 2015. A study reported at the American Society for Reproductive Medicine 2016 Scientific Congress found a 63.9% drop in all myomectomies (both laparoscopic and abdominal) following FDA’s warning.

“Many of the existing studies evaluating the impact of the FDA warning against power morcellation have shown a decrease in use of power morcellation,” Dr. Deirdre Lum told Medscape Medical News.

Dr. Lum suggested that the FDA’s warning may have raised fears about tissue disruption in general, steering patients and their doctors towards other fibroid treatment options.

Olympus Morcellator Cleared Based on “Substantial Equivalence”

The Olympus PK Morcellator is designed for the very same surgeries that the FDA warned against. But whether the PK Morcellator poses equivalent cancer-spreading risk is difficult to determine, because the device did not undergo human testing.

The FDA approved Olympus’ morcellator under its 510(k) program, which allows device makers to forego human testing if the new product is “substantially equivalent” to already-approved devices (so-called “predicate devices”).

FDA documents show few design differences between the PK Morcellator and its predecessor. For example, the PK and its predecessor have the same dimensions, mode of tissue dissection, and sterilization.

New for the PK is a “peeling” method of tissue morcellation, compared to a “coring” morcellation technique used in the predicate. The PK also is designed to be used with the “first of its kind” PneumoLiner containment bag—a device designed to contain morcellated tissue

The FDA, however, acknowledges that “the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.”

PneumoLiner was cleared through FDA’s de novo classification process. Although different than the 510(k) process, de novo classification similarly allows devices to escape the much more rigorous premarket approval process.

Neither the PK Morcellator nor its containment bag underwent human testing.

Research published in The Journal of Minimally Invasive Gynecology found that approximately 1 in 10 morcellation containment bags leaked and spread tissue.

There have been calls for power morcellators to be pulled from the market, or at the very least, classified as high-risk devices, which would necessitate premarket approval testing.

Johnson & Johnson’s Ethicon unit withdrew its morcellators from the market following the FDA’s warning. In March 2016, J&J settled the majority of the morcellator lawsuits it is facing for $100,000 to $1 million per case.

Lawsuits against other morcellator manufacturers are ongoing. Please contact us if you or a loved one had cancer spread throughout your body by a power morcellator.

Hospital Failures Undermine FDA Device Safety Efforts

Hospitals and manufacturers routinely fail to report medical device-related deaths, injuries, and other safety data to the Food and Drug Administration, in violation of federal rules and to the detriment of medical device safety monitoring. FDA fecklessness often compounds these issues, leading to avoidable patient harm.

ClassAction.com wants to remind consumers that you can report medical device problems directly to the FDA through its website.

You can also report problems to ClassAction.com and find out if you have a legal cause of action against a device manufacturer.

Hospitals and Manufacturers Play Key Roles in Data Collection

The FDA is tasked with balancing the need to quickly bring new, life-enhancing technology to market with the need to ensure device safety and effectiveness prior to marketing. Accordingly, FDA relies on both premarket evaluation (including clinical studies) and post-market surveillance (monitoring devices once they are cleared for sale).

FDA relies on premarket and post-market data to evaluate medical device safety.

Medical device reporting is among the post-market surveillance tools available to the FDA. Federal law requires that hospitals notify the manufacturer within 10 days of a serious injury possibly related to a medical device and notify both the manufacturer and the FDA of a possible device-related death. Hospitals must also submit annual reports to the FDA at the start of each calendar year.

Device manufacturers have reporting duties as well. A manufacturer must file FDA reports within 30 days of learning about an injury or death linked to one of its products.

FDA Inspections Reveal Reporting Lapses

In response to a number of high-profile device safety issues associated with power morcellators and duodenoscopes that hospitals failed to report, the FDA performed inspections at 17 hospitals where issues with those devices allegedly occurred.

The inspections revealed reporting issues at prominent medical centers, the FDA disclosed in October 2016, including at Massachusetts General Hospital in Boston, New York Presbyterian Hospital, and the Ronald Reagan UCLA Medical Center.

Issues uncovered in the inspections include failure to submit required reports, inadequate reporting procedures, and a lack of reporting requirements awareness and training on the part of hospital staff.

Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, addressed these reporting lapses in a blog post and said that while certain hospitals were singled out, the issues are widespread.

“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals. We want to work with all hospitals to address these issues,” said Mr. Shuren.

The FDA will hold a workshop in December to discuss ways to improve hospital-based surveillance efforts.

Patients interested in taking a proactive role in medical device adverse event reporting can submit reports online through MedWatch.

FDA Medical Device Oversight Criticized

The FDA’s hospital inspections were driven by criticism that the agency is not doing a good enough job tracking medical devices.

A Senate investigation into superbug outbreaks at hospitals linked to duodenoscopes—tube-like medical devices inserted through the mouth into the stomach and intestine for minimally invasive procedures—found that poor FDA oversight was to blame.

Device manufacturers’ main goal is to quickly get new products to market—not to protect patient health.

“This investigation clearly demonstrates the inability of FDA’s current device surveillance system to accurately identify the extent of device problems when they occur, which poses an unacceptable risk to patients,” concluded the Senate in its January 2016 report.

The report recommends that FDA make changes to its 510(k) approval process, a fast-track process that allows devices to be cleared for sale without rigorous premarket testing if they are “substantially equivalent” to devices already sold. FDA clears dozens of high-risk medical devices each year through the 510(k) process. Many of the most high-profile product defect lawsuits in recent memory have involved 510(k)-approved devices, including metal hips, transvaginal mesh, and power morcellators.

A 510(k) submission is also required when a manufacturer modifies a medical device in a way that might impact safety or effectiveness.

According to the Senate report, manufacturers of duodenoscopes blamed for spreading antibiotic-resistant infections between 2012 and 2015 made substantial design changes to the devices that affected their decontamination specifications, but failed to submit relevant 510(k) applications. By the time the FDA determined applications should have been submitted, the devices had been in use—and spreading infections—for years. At least one manufacturer was aware of contamination problems but failed to disclose them.

The Senate report notes it is up to manufacturers to determine if and when a 510(k) application is warranted. Yet this creates a strong conflict of interest, since manufacturers’ main goal is to quickly get new products to market.

In fact, an over-reliance on manufacturers and hospitals to self-report device safety information places consumers at the mercy of organizations that have incentives not to make rapid and robust disclosures for fear of costly litigation.

While a stronger FDA can help to protect patient safety, patients should take steps to help themselves, such as reporting directly to the FDA and holding companies accountable.