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FDA and Drug Research: Watching Our Backs or Asleep at the Wheel?

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FDA inspections hidden
apops/Dollar Photo Club

Our world of medicine is dominated by drugs.  Drugs are the foundation upon just about every treatment that mainstream medicine offers.

The entire Affordable Care Act (aka Obamacare) was passed so that patients could now have access to doctors.  And by “access” I mean have someone else pay for services.  And by “services” I really mean drugs.

While this sounds simplistic and singleminded, think about it for a second.  If you KNEW you had high blood pressure, high cholesterol or were overweight and did not want to use drugs, would you make an appointment with your primary care doctor to find out how to change your lifestyle for the better?  Typically not.

No, the creation of the Medicare Part D program, the expansion of Medicaid across the country and the creation of the Affordable Care Act were all about one thing: getting access to doctors to get prescriptions for drugs.  Prescription drugs are the #3 most expensive line item in health care costs (and its growth is by far outpacing the #1 and #2 slots), with #2 being physician costs (the gatekeeper to get the drugs) and #1 being hospital costs.

At the heart of all the research and safety and protection for these drugs to the public is the Food and Drug Administration.  The FDA, as it became officially known as in 1930, has, for over a century, been a government watchdog for the safety of the general public.  One of the largest roles of the FDA is to oversee the approval and use of pharmaceutical drugs used on you and I.

And lord knows we need it.  Drug companies fulfill the archetypical big corporation in the most evil Hollywood blockbuster stereotype, using bribes and seedy marketing techniques to get patients to request their drugs and doctors to prescribe them.  There is little doubt that illegal activities and the fines that accompanying them (when caught) are just a part of the general business plan and put in as a line item expense.

With this business model, the FDA is the only thing standing between your safety and the pharmacetical industry’s desire to turn a massive profit.  And for many years the FDA has done an arguably wonderful job at this task.  However, in recent years, the industry has been plagued with less-than-adequate funding as well as internal influence from the very drug companies they were designed to oversee.

One of the ways that the FDA provides oversight on the drug companies is to inspect several hundred clinical sites performing biomedical research on human participants.  They will occasionally find evidence of substantial departures from good clinical practice and research misconduct. This is really good information for other researchers, grant agencies and regulators to know about.

But what if this information was essentially kept secret?  What if this important information never had an effect on that trial getting published and the study data used to drive your doctor’s opinion on how he or she should treat you?  That’s exactly what researchers looked at in this particular study.

They spent time digging around the FDA’s inspection documents that could be linked to a specific published clinical trial.  In comparing the inspection documents, the researchers looked for whether there was a mention in the published clinical trial of problems the FDA had identified.  Here’s what they found:

  • 57 trials were identified for which an FDA inspection of a trial site had found significant evidence of at least one problem.
  • Falsification or submission of false information was found in 22 trials (39%).
  • Problems with adverse events reporting was found in 14 trials (25%).
  • Protocol violations were found in a big chunk (42 trials or 74%).
  • Inadequate or inaccurate record keeping was found in 35 trials (61%).
  • Failure to protect the safety of patients and/or issues with oversight or informed consent in 30 trials (53%).
  • Other violations not otherwise categorized in 20 trials (35%).

Ok.  So they made some mistakes.  Haven’t we all faked the data on a lab report or lied about how bad we felt to get out of school?  And to heck with protocols–we all just make stuff up as we go along to the outcome is more likely to be in our favor.  And who REALLY cares about the safety of the patients?  It’s all about what’s good for everyone, right?

But none of this matters so long as you come clean in the end with the people you have deceived or lied to.  Unfortunately, the researchers found that this was a rarity.  Only 3 of the 78 publications (a measly 4%) mentioned the misconduct found during the inspection.

So what is the point of having these FDA inspections if the findings are essentially kept a big secret?  Just remember this little study the next time your doctor tells you about how clinical studies have shown that Drug X was safe and actually helped patients with your condition.

 

Public Citizen Says FDA Fraudulently Approved Food Irradiation – (11-02-00)

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Public Citizen Says FDA Fraudulently Approved Food Irradiation

The FDA is under heavy attack these days with accusations of fraud and abuse. Top among these is the revelation that some 52% of FDA panel members had financial ties to the drug companies they were supposed to regulate. Governmental agencies are fraught with abuse and can no longer be considered as reliable information relating to your health.

(article) The Food and Drug Administration should withdraw its approval of food irradiation to kill bacteria, said the advocacy group Public Citizen on Tuesday, claiming that the agency based its acceptance of the technology on faulty studies. Joined by the Cancer Prevention Coalition and several environmental protection organizations, Public Citizen and the other groups said there were numerous public health threats posed by applying ionizing radiation to food. The groups documented their charges in a lengthy report issued at a press briefing. The report, called “A Broken Record—How the FDA Legalized, and Continues to Legalize, Food Irradiation Without Testing it For Safety,” shows that “FDA has failed in its mandate to protect consumers,” said Wenonah Hauter, director of Public Citizen’s Critical Mass Energy and Environment Program. Samuel Epstein, an expert on carcinogenicity and chairman of the Cancer Prevention Coalition, said there is overwhelming evidence that radiation cuts the nutritional value of food by a third, and that once cooked, the food has no nutritional value left. Epstein also said that there is a large body of evidence that irradiation poses a threat to human fertility and reproductive viability, and that it appears that many of the chemicals created as byproducts are carcinogenic to humans. For instance, benzene, a known carcinogen, is a byproduct that appears in large quantities in irradiated beef, according to the Public Citizen report.

FDA Clears Beckman Coulter’s Osteoporosis Blood Test – (05-20-00)

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FDA Clears Beckman Coulter’s Osteoporosis Blood Test

What amazes me about this is that several labs in the country have been running tests for bone turnover for YEARS now!! And, even better, they use urine to test the rate at which bone is being broken down. The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Beckman Coulter for its Access Ostase blood test for use in managing osteoporosis and Paget’s disease. The new test, known in the industry as a “bone turnover marker,” will be the first automated, serum-based assay sold and updates the firm’s own manual assay, the Hybritech Ostase Test, Beckman Public Affairs Associate Jobe Dubbs told Reuters Health.

Drug Firms Fail to Conduct Post-Marketing Studies – (05-20-00)

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Drug Firms Fail to Conduct Post-Marketing Studies

Sometimes it seems that the government has less and less control over the pharmaceutical companies. This is a perfect example of the drug companies ignoring mandates from the FDA. Apr 17 (Reuters) – Most of the studies that federal health officials require drug companies to perform on new medicines after they hit the market are never done, a US consumer group charged on Thursday. Often when the Food and Drug Administration (FDA) approves a drug, it orders the manufacturer to conduct further studies of side effects or how well it works for certain patients. But only 13% of the 88 follow-up studies required for drugs launched in the early 1990s were completed, according to a report by consumer group Public Citizen. No studies were finished for 107 drugs that went on the market between January 1995 and last December, the group said.

Public Citizen Urges FDA Not to Approve Tegaserod For IBS – (04-30-01)

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Public Citizen Urges FDA Not to Approve Tegaserod For IBS

There have been numerous attempts by the pharmaceuticals to tap into the irritable bowel syndrome market. The first attempt was pulled off the market for safety concerns (Glaxo Wellcome’s Lotronex for diarrhea-dominant IBS). Tegaserod is the latest attempt to help with constipation-dominant IBS. It’s a shame that all this money is spent on R&D when natural physicians have been doing well with IBS for years…

(article) Consumer advocacy group Public Citizen has petitioned the US Food and Drug Administration not to approve Novartis Pharmaceuticals’ drug candidate tegaserod (Zelmac) as a treatment for the constipation-predominant form of irritable bowel syndrome (IBS), citing the drug’s “questionable efficacy” and “serious safety concerns.” In August, the FDA issued the Swiss pharmaceuticals firm an approvable letter for tegaserod, with final approval conditioned on the submission of additional clinical data. FDA reviewers have estimated that tegaserod recipients were three times more likely to develop cysts than placebo recipients, Public Citizen asserts in the letter. It noted that in animal trials the compound “caused a statistically significant, dose-related increase in their incidence.” In addition, the drug has not even been proven effective, Public Citizen maintains. “Only a minority of patients ‘respond’ to the drug and the absolute benefits conferred (compared to placebo) are not clinically significant,” it said.

NVIC Says IOM Report Confirms 1999 FDA/EPA Order for Mercury-Free – (10-08-01)

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NVIC Says IOM Report Confirms 1999 FDA/EPA Order for Mercury-Free

If just seems interesting that chiropractors have been warning about the dangers of vaccines for decades and been called heretics, unscientific and worse for this belief. And yet, as time progresses, we see more and more stuff arising about the dangers of the mass-immunization practice here in the US. How could anyone ever have considered mercury as safe to use at any level? The whole concept to me seems unfathomable. Now we see much backpeddling on the part of the governement agencies–thimerisol is safe, but we still need to spend millions getting rid of it. See any dichotomy here???

The nation’s oldest and largest vaccine safety advocacy organization, the National Vaccine Information Center (NVIC), today called the Institute of Medicine (IOM) report evaluating whether mercury preservatives in vaccines have caused developmental delays in children a “confirmation” that the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) were justified in ordering drug companies to take mercury out of childhood vaccines in 1999. Although the IOM’s Immunization Safety Review Committee concluded there is not enough evidence to prove or disprove the hypothesis that mercury-containing vaccines have caused children to develop learning disabilities, attention deficit hyperactivity disorder, and autism, the IOM Committee found enough evidence that mercury can damage the human brain to recommend that mercury preservatives be removed from all vaccines and over-the-counter consumer products.”This IOM report confirms the obvious: mercury is bad for you and we shouldn’t be injecting our babies with it. Even though there have been too few controlled studies to confirm the relationship between mercury-containing vaccines and various kinds of brain dysfunction, the bottom line is that drug companies should have come up with a non-toxic way to preserve the stability of vaccines a long time ago. Now we need a comprehensive analysis of the potential toxicity of all other vaccine additives, starting with aluminum,” said Barbara Loe Fisher, co-founder and president of NVIC.NVIC has recently joined with SAFEMINDS, founded in 2000 by parents who believe their children were harmed by mercury in vaccines, in calling for the removal of all mercury-containing childhood vaccines from the market in the United States and for doctors to warn pregnant women that the flu vaccine contains mercury.

US Supreme Court Says Law Bars Suits on Medical Devices – (03-08-01)

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US Supreme Court Says Law Bars Suits on Medical Devices

Let me get this straight. The FDA has the final say in whether a medical related device is safe enough to be released to the public. This information is almost always provided by the manufacturer wishing to market the item. Bias in the info provided and financial ties with the FDA are well known and even documented in some cases. Now, the Supreme Court basically says it’s okay for the manufacturer to provide fraudulent info to the FDA to get their item approved???? And yet the safety of supplements is frequently called into question?? People in glass houses…

(article) The US Supreme Court on Wednesday ruled that individuals cannot sue manufacturers of medical devices for allegedly defrauding the US Food and Drug Administration (FDA) in order to win marketing approval. The case involved a lawsuit in which more than 5,000 individuals accused a company of fraudulently winning federal approval for marketing bone screws used in spinal surgery. The lawsuit alleged that the Buckman Co., a consulting firm for medical device manufacturers, used misrepresentations to get FDA approval in 1986 for marketing a device known as the Variable Screw Placement Spinal Plate Fixation System. The ruling also was a victory for the company. Chief Justice William Rehnquist said for the court that a US appeals court had been wrong in reinstating the claims against the company and allowing the lawsuit to go forward. Allowing such lawsuits might expose manufacturers of medical devices to “unpredictable civil liability,” he said. Rehnquist said the federal regulatory scheme amply empowered the FDA to punish and deter fraud against the agency, and that the FDA used its authority to achieve a delicate balance of objectives that can be skewed by allowing such lawsuits. “The FDA…has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the agency,” Rehnquist said in the opinion. He said this flexibility was a critical component of the framework under which the FDA pursues its objective of regulating marketing and distribution of medical devices. Rehnquist said state law fraud claims inevitably conflict with the FDA’s responsibility to police fraud. He said companies complying with the FDA’s detailed regulatory regime, but then facing possible lawsuits under the laws of 50 states, might be deterred from seeking approval of devices with potentially beneficial uses. In the case at issue, the FDA had rejected Buckman’s two previous applications, made on behalf of AcroMed Corp., for marketing the device. But a third application, which separated the device into its component parts and which said the screws were intended to be used in the arm and leg bones, won FDA approval. The plaintiffs claimed they were injured when their doctors implanted the device into their spines and alleged that Buckman had perpetrated a fraud on the FDA. The individual claims seeking monetary damages were consolidated into one lawsuit. The lawsuit said that Buckman won FDA approval under a pretext because the intention all along had been to market the bone screws for use in spinal surgery. The FDA did not approve the marketing of bone screws for spinal surgery until 1995.

Volunteer’s Death Prompts Review – (07-02-01)

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Volunteer’s Death Prompts Review

Think this one will pass FDA approval? You might be surprised… All kidding aside, just remember that many times the general public serves as the true guinea pigs for many new drugs. The list of drugs that were pulled off the market after dangerous side effects were found after the drug was approved is quite long. The ironic thing is that many natural compound have literally thousands of years of safe use and yet their use is looked upon with skepticism by much of the medical community.

Science — Marshall 292 (5525): 2226b

Read entire article here