One of the primary roles of the U.S. Food and Drug Administration (FDA) is to review the safety and efficacy of new drugs before approving them for the U.S. market.
Clearly an objective, unbiased review is needed for this system to work, but a new study published in The British Medical Journal (BMJ) suggests conflicts of interest are rampant.
October 11, 2016
Story at-a-glance
- In an analysis of 55 former FDA medical reviewers, 15 subsequently took jobs with the biopharmaceutical industry
- FDA reviewers considering future work in the drug industry may be more lenient when assessing new drug applications
- The FDA granted 45 new drug approvals in 2015, which is the most new drug approvals granted in one year since 1996
By Dr. Mercola
One of the primary roles of the U.S. Food and Drug Administration (FDA) is to review the safety and efficacy of new drugs before approving them for the U.S. market.
Clearly an objective, unbiased review is needed for this system to work, but a new study published in The British Medical Journal (BMJ) suggests conflicts of interest are rampant.
A much-used revolving door exists between the FDA and the pharmaceutical industry, which is putting Americans' health at jeopardy for the sake of the drug industry's (and individuals') monetary pursuits.
Such cozy ties have been revealed before, but for the new study the researchers, from Oregon Health and Science University, wanted to find out just how prevalent they actually are.
Concerning Numbers of FDA Employees Leave Agency to Work for Drug Industry
The researchers analyzed data on FDA hematology-oncology drug approvals from 2006 to 2010 along with medical reviews conducted from 2001 to 2010. They then found out the subsequent jobs of the former FDA medical reviewers that worked on those drug approvals.1
Out of 55 people, 15 left their job at the FDA to work or consult for the biopharmaceutical industry (another 29 continued working at the FDA in some capacity while the rest of the jobs could not be determined).2
Study author Dr. Vinay Prasad, a hematologist-oncologist and assistant professor of medicine at the Oregon Health and Science University, cited a need to understand why so many people are leaving the FDA.
He pointed out that while working at the FDA "they're certainly earning less than what they can make in the [pharmaceutical] industry." He continued in Time:3
"I don't think there is overt collusion going on, but if you know in the back of your mind that a major career opportunity after the FDA is going to work on the other side of the table, I worry it can make you less likely to put your foot down
… Regulators may be less willing to be very tough, and I worry that is happening."
The FDA Is Supposed to Stop Harmful Drugs From Reaching the US Public
The revolving-door trend is particularly troublesome in the hematology-oncology field, an area of medicine where the drugs may be highly toxic with only minimal benefits. The researchers noted much room for "interpretation" when reviewing such drugs.
For instance, many cancer drug studies use surrogate endpoints, which means the study may not reveal whether the drug improves survival or quality of life, but instead may evaluate a different outcome, such as tumor shrinkage.
The problem is that it's often unknown whether the surrogate endpoint, such as tumor shrinkage, leads to better health outcomes.
The end result, as Kaiser Health News reported, is that FDA-approved drugs may appear to be more beneficial than they really are. And, once FDA-approved, these drugs must be covered by Medicare and Medicaid programs, and the agencies are unable to negotiate prices.4
Further, when a reviewer is poised to work for the drug company manufacturing a borderline drug, he's likely to be more lenient. If a reviewer plans to someday work for the drug company in question, for instance, Prasad told Kaiser Health News:5
"Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"
… Sometimes, the public needs [the FDA reviewers] to be firm. If they're not, no one else in the health care sector is going to be … The FDA is often the only real wall between ineffective, harmful drugs and patients."
Former FDA Commissioner Says She Won't Consider Big Pharma Work for a 'Couple of Years'
In what she described as a "cooling-off period," former FDA commissioner Dr. Margaret Hamburg said she would not consider working for companies regulated by the FDA for "a couple years."6
The FDA requires a waiting period of this type from former senior employees, although the featured study pointed out numerous anecdotal reports of employees going directly to work for the pharmaceutical industry.
Even a couple-year lag time added in to the revolving door does little to assuage concerns of cozy ties between regulators and industry.
In Hamburg's case, the revolving door worked both ways, as she was previously employed by industry before joining the FDA. She stepped down as commissioner at the end of March 2015.
Hamburg entered the FDA through the revolving government/private industry door after allegedly making millions as the director of Henry Schein Inc., the largest seller of dental amalgam (mercury fillings). Schein is a flu vaccine seller as well.7
Dr. Michael Carome, director of the health research group at Public Citizen, has been more critical, calling her tenure a period of "weak and ineffective leadership." He said in a statement in 2015:8
"Too often, the FDA has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical-device companies, and away from protecting public health …
Throughout Hamburg's tenure, the FDA has grown even more cozy with the industries that it regulates."
2015 Was a Banner Year for New Drug Approvals
There is perhaps no better evidence of where the FDA's loyalty lies than in the sheer number of new drug approvals granted in 2015 — 45 in all, which is the most new drug approvals granted in one year since 1996.9
Chemistry & Engineering News reported that "few products approved in 2015 stood out as major breakthroughs," and continued:10
"Rather, many of the new drugs were notable more for their breathtaking price tags and how swiftly they moved to the market than for their ability to transform lives."
About 60 percent of the new drug approvals were also granted some type of expedited review process, allowing them to come to market faster. Many believe the speedy drug approvals come at the expense of safety.
An increasing number of New Drug Applications are also getting approved on their first attempt, meaning the FDA did not ask for any additional testing or information. Eighty-seven percent of new drug applications were approved on the first go-around in 2015 compared to just 56 percent in 2010.11
Also of note, 12 of the drugs approved in 2015 come with a more than $100,000 price tag per year, while others must be taken in combination with other exorbitantly priced drugs, "easily bringing the combined annual cost of treatment into the six figures," according to Chemistry & Engineering News.
How Financial Interests Affect FDA Member Voting Behaviors
It goes without saying that researchers and policy makers with financial ties to industry should not be permitted to participate in public health recommendations relating to said industry. Unfortunately, this blatant conflict of interest happens all the time.
In 2014, for instance, a study published in the Milbank Quarterly journal revealed how financial interests affected the voting behavior of nearly 1,400 FDA advisory committee members who took part in drug approval decisions between 1997 and 2011.12
On average, 13 percent of the members in any given committee had financial interest in the company whose drug was up for a review by that committee. About one-third of financial interests involved consulting for a drug maker, 25 percent involved ownership interest and 14 percent involved serving on an industry advisory board or steering committee.
Committee members with financial ties to the company sponsoring the drug under review voted in favor of approval 63 percent of the time while members who did not have financial ties had a 52 percent chance of favoring approval. Committee members who served on a sponsoring firm's advisory board, meanwhile, voted in favor of the drug's approval 84 percent of the time.
FDA Lets Fraud and Misconduct in Clinical Trials Slide
The FDA reviews several hundred sites that conduct research on human participants each year in order to be sure they're engaging in good clinical practice. But what happens when they find evidence of questionable procedures or practices?
In the most serious of cases, the FDA can classify it as "official action indicated," or OAI. This is reserved for "severe" forms of clinical trial violations, including "objectionable conditions or practices" that warrant compulsory regulatory action, as opposed to "voluntary action indicated" for lesser violations."13
Now, if a trial had been deemed OAI by the FDA, you might assume that you'd see evidence of that when reading the results of studies based on said data. But that would be a liberal assumption. Researchers conducted a review of FDA inspection reports between 1998 and 2013.14
They found 60 clinical trials that had been classified as OAI, and these trials had been used for data in 78 published articles. Out of those 78 studies, only three included mentions of the violations found by the FDA.
The violations included fraud, incompetence and misconduct. This means that anyone browsing a medical journal (such as your physician) might be making decisions based on fraudulent or heavily flawedpublished studies — and have no way of knowing that this is the case. Of the 57 OAI trials:15
- 22 had falsified information
- 14 trials had researchers who failed to report adverse events
- 42 trials had violations of the trial's protocols
- 35 trials had record-keeping errors
- 30 trials had researchers who failed to protect patient safety or acquire informed consent
Increased Transparency Might Help
The FDA devotes an entire section of its website to transparency and says they're engaged in an "agency-wide effort to open the doors of the agency."16 Whether this is occurring in practice is questionable. In the above-referenced OAI study, for instance, most of the documents obtained by students were heavily redacted.
In some cases, they couldn't even tell what drug was being tested, and they believed they would have uncovered even more violations if not for the redaction.17
Ultimately, you are responsible for your and your family's health, so be sure you feel completely comfortable with any related decisions you make. If you're facing a health challenge, choose health care practitioners who really understand health at a foundational level and have extensive experience helping others (and don't be afraid to ask for references and seek corroboration).
Unfortunately, you simply cannot place your blind faith in agencies like the FDA, as they are currently too embroiled with industry to at the same time be an effective watchdog for public health.
http://articles.mercola.com/sites/articles/archive/2016/10/11/fda-big-pharma.aspx?
