By Dr. Mercola
As stated in their mission statement, the US Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety and efficacy of drugs, biological products, medical devices, food, and more.1
It’s a tall order, no doubt, but the FDA makes many glaring omissions or, some might say, blatant oversights that put the public’s health at risk. Yet, the public is quite understanding and tolerant of the FDA’s mistakes and industry-friendly positions.
For instance, even as they continue to ignore the risks of antibiotics in animal feed, deceive you about mercury amalgams, and allow Americans to consume questionable foods that are banned in other countries…
There is no major public uproar or demand for a (much-needed) overhaul of the agency. But it is hard to defend an agency that continually acts against the best interests of the public they’re entrusted to defend.
Now, due to the efforts of a professor and his students at the Arthur L. Carter Institute of Journalism at New York University, we have yet another example of the FDA failing to warn Americans, in this case about grave concerns due to falsifications in published data.
FDA Uncovers Fraud, Incompetence, and Misconduct in Clinical Trials… Says Nothing
The FDA reviews several hundred clinical trial locations 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.”2
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.
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!
And we’re not talking about small, innocent mistakes. The violations included fraud, incompetence, and misconduct. This means that anyone browsing a medical journal might be making decisions based on fraudulent published studies.
Studies that the FDA knows contain grave errors… but chose not to say anything about. While you might not personally read this misleading data, your doctor might. As the study’s lead researcher, Charles Seife, noted:3
“Your physician makes decisions based upon what he knows from the peer-reviewed literature… If that literature is tainted in some way without the physician knowing, then the physician is making treatment decisions based upon bad data."
Widespread Scientific Fraud, Limb Amputations… Even a Related Homicide Case!
In all, the study found about 2 percent of the close to 650 FDA inspections were classified as OAI. Among the violations was a trial in which patients were treated with stem cells to treat poor blood flow in a leg.
The trial reported that all patients reported improvement in their limbs… but one person had to have a foot amputated two weeks after the treatment.
In another case, the FDA said “systematic and widespread scientific fraud” made a trial of the blood-thinning drug rivaroxaban unreliable. But no mention of this fraud is made in the journals that published its findings.4
In another particularly egregious case, a researcher falsified documents that lead to the death of a chemotherapy patient. The researcher pleaded guilty to fraud and went to prison for criminally negligent homicide … but again, the related published studies make no mention of this.5 Of the 57 OAI trials:6
- 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
FDA Says They’re Moving Toward Transparency, Yet Heavily Redacts Information
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.”7 Yet, most of the documents obtained by students for the featured study were heavily redacted.
In some cases, Seife noted, you couldn’t even tell what drug was being tested… and he believes his team would have uncovered even more violations if not for the redaction.8 In a scathing review in Slate, Seife wrote:9
“Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing.
Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching. That misconduct happens isn’t shocking.
What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary.
For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.
The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market.
Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”
Conflict of Interest Rampant in GRAS Panels
When the 1958 Food Additives Amendment was enacted, the exclusion of GRAS items from the formal FDA approval process for food additives was meant to apply to common food ingredients such as vinegar, i.e. items known through their historical use as being safe. Nowadays, however, countless manufactured ingredients end up slipping through this loophole.
A company can simply hire an industry insider—a completely conflicted "expert"—to evaluate the chemical, and if that individual determines that the chemical meets federal safety standards, it can be deemed GRAS without any involvement from the FDA. A study published in JAMA Internal Medicine revealed that the individuals companies select to make these “expert” determinations often have conflicts of interest.10 In fact, of the 451 GRAS notifications reviewed:
- 22 percent of the safety assessments were made by an employee of the additive manufacturer
- 13 percent were made by an employee of a consulting firm selected by the manufacturer
- 64 percent were made by an expert panel selected by either a consulting firm or the manufacturer
The researchers concluded that conflicts of interest in approvals of GRAS food additives are rampant and deserve attention from the FDA: “Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.”
The FDA has created a voluntary program that asks food companies to submit their safety assessments for FDA review. If the agency cannot find any major problems with the company's argument for GRAS status, a "no questions" letter is sent to the company. However, if questions about safety are raised by FDA scientists, the company can simply withdraw its voluntary submission, and go on using the chemical as if nothing has happened.
This legal loophole in the law allows food manufacturers to market novel chemicals in their products based on nothing but their own safety studies, and their own safety assessments—the results of which can be kept a secret. As Marion Nestle, Ph.D., Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University, said:11 “How is it possible that the F.D.A. permits manufacturers to decide for themselves whether their food additives are safe?”
How Independent Are Vaccine Supporters?
Conflict of interest is pervasive not just in the food industry but also in the medical field. As attacks against those who support vaccine choice rage on at an all-time high, it is important to understand who’s behind some of the most prominent vaccine supporters. In an investigation by CBS News correspondent Sharyl Attkisson, she revealed strong financial ties between the vaccine industry and the American Academy of Pediatrics (AAP), for starters. Among them, the agency received:12
- $324,000 from Wyeth, maker of the pneumococcal vaccine
- $433,000 from Merck, the same year AAP endorsed their HPV vaccine
- Additional contributions from Sanofi Aventis, maker of 17 vaccines
The pro-vaccine group Every Child by Two has also received money from the vaccine industry, as has Dr. Paul Offit, who is one of the most outspoken defenders of vaccine safety. Dr. Offit received a reported $350,000 grant from Merck to develop a rotavirus vaccine, and has served on the scientific advisory board for Merck. He received another estimated $6 million when Children's Hospital of Philadelphia (CHOP) sold the patent for the RotaTeq vaccine he developed. He was also on the CDC advisory board that approved the addition of a rotavirus vaccine to the US National Immunization Program (NIP) in 1998—a decision that paid off handsomely.
The original rotavirus vaccine added to the NIP, which was made by a competitor, was pulled from the market due to adverse effects. The RotaTeq vaccine replaced it, and he continues to receive royalty payments from the sale of RotaTeq to this day. (According to Wired Magazine,13 Merck's revenue from RotaTeq was $665 million in 2008 alone, of which Offit and his RotaTeq co-creators are said to receive a percentage.)
Hit Lists, Pay Offs, and Fake Journals All Par for the Course
Drug giant Merck has fortunately stopped promoting the mandatory use of Gardasil, the useless human papillomavirus (HPV) vaccine. Their campaign to promote it (back in the 2000s) was dubbed by some as the Help pay for Vioxx Litigation campaign (Vioxx is linked to heart attacks and was pulled from the market after it had killed more than 60,000 people). As noted by CorpWatch:14
“…revelations of money trails and the rush to make a new vaccine mandatory created a backlash and forced Merck, on February 20th , to publicly abort its lobbying campaign for mandatory vaccination of school girls.”
Two legislators from Maine, Marilyn Canavan and Andrea Boland, painted a particularly poignant picture of who’s really running the show. At a conference organized by the non-profit organization Women in Government (WIG), they described one-sided “presentations” (not discussion) aimed at getting the female legislators on board with vaccination. According to CorpWatch:15
“Boland, a first-time legislator, joined Canavan, a WIG state director, at a small planning session, where she was taken aback by the extent to which corporations influenced WIG. ‘When discussing what the agenda for next year would be,’ participants were told to 'wait to see who's funding things.'" Similarly before fixing the program for next year, they ‘had to see what the sponsors want,’ said Boland.”
Merck is the same company that created a fake “peer-reviewed” journal called The Australasian Journal of Bone and Joint Medicine to promote pro-Vioxx articles.16 Merck even had a hit list of doctors who had to be "neutralized" or discredited because they had criticized the painkiller Vioxx. Those who made it onto Merck’s “hit list” said they experienced instances of intimidation, including suggestions that Merck would stop funding the institution or interfere with academic appointments.
This clearly gets in the way of academic freedom, researchers’ ability to accurately report their findings, and doctors’ ability to speak out against a drug they believe is harmful. But then that is what Merck was after. Adding to the issue, of course, is that this is probably not an isolated occurrence. Drug companies could be keeping any number of lists of people who are interfering with their ability to sell and make profits, and my guess is that they are at work “neutralizing” those people as we speak. In fact, I would bet on it.
Only Two Countries Allow Direct-to-Consumer (DTC) Drug Advertising
The US is one of them (New Zealand is the other). What is DTC advertising? It’s that barrage of ads you see on TV and in magazines and newspapers, or on the radio and Internet. They're ads telling you to run right out and ask your doctor if this or that pill would be right for you. Some drug companies have even taken to advertising highly specialized medical devices, like heart stents. It's a marketing bonanza that's turned America into a medicated mass of people who've been brain-washed into thinking that taking pills will make everything better―even for ailments you might not have.
But it's a brilliant move for Big Pharma, who has now turned the consumer into their very own sales rep, and a persuasive one at that. Not only is there a correlation between the amount of money drug companies spend on DTC advertising and the brand of drug patients request from their physicians, but the data shows DTC advertising rapidly converts people into patients. As mentioned by Alternet:17
"It's a disgusting, dishonorable way to generate sales--but it works. In 2008, the House Commerce Committee found that every $1,000 spent on drug ads produces 24 new patients,18 and a 2003 research report found that prescription rates for drugs promoted with DTC ads were nearly seven times greater than those without such promos.19 Ethics aside, these consumer hustles have proven to be profit bonanzas."
As you might suspect, the use of DTC ads has grown rapidly since it was first approved in the U.S. in 1997. At that time, the ads could only be run along with lengthy consumer information warning of risks and side effects, so few companies used them. In 1997, the FDA revised the rule so that rather than providing a full disclosure, companies only needed to meet an "adequate standard" when it came to describing risks to consumers. Although viewed as a relatively recent phenomenon, drug advertising has a long and sordid history, as reported in the American Journal of Public Health:20
“Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century.”
In an Era of Bias, Conflict of Interest, and Confusion: Take Control of Your Health
Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the US your chance of achieving optimal health through the conventional medical system is getting progressively worse. As just one example, while the US spends more than twice the amount on health care as other developed nations, we rank 49th in life expectancy worldwide—far lower than most other developed nations ... When it comes to your health, you simply cannot accept claims at their face value… Quite often—definitely too frequently for comfort—treatment recommendations are biased in favor of a specific drug simply because people making the decisions stand to profit from it.
Whatever your health problem might be, I strongly recommend digging below the surface using all the resources available to you; including your own commonsense and reason, true independent experts' advice and others' experiences to determine what medical treatment or advice will be best for you. 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 healthcare 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).
Of course, I always advise taking control of your health, which you can easily do by reviewing my comprehensive nutrition plan that summarizes my 30 years of clinical experience and treating 25,000 patients. I put this together so you can stay well and avoid having to rely on information that gives the perception of science when it is actually too heavily flawed or manipulated to benefit your health. Most of us live in free enough countries where we still have the ability to take back control of our health… we just need to grab the initiative.