The Alliance For Natural Health

The FDA and Industry Conspire to Suppress Drug Trial Safety Concerns

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Drug research, even from clinical trials sponsored by the federal government, is routinely suppressed. Industry can keep secret studies that show adverse effects of drugs—and the FDA has previously hidden safety information when it uncovers scientific misconduct in clinical trials of pharmaceutical drugs. One company, Cetero, was caught faking data from more than 1,400 drug trials that were used to prove the safety of about 100 drugs. Incredibly, after the FDA caught Cetero, the fraudulent data was still on the drug labels. We discuss other examples of fraud below.

The agency also has refused to prosecute wrongdoers since a successful lawsuit would mean the government could no longer do business with the offending company. This means that when a company becomes too deeply enmeshed in the government’s business, it simply becomes too big to prosecute for intentionally suppressing evidence that demonstrates the dangers of a drug, or any other criminal misconduct that result in deaths or sickness.

A study in the British Medical Journal (BMJ) found that less than half of all NIH-funded clinical drug trials were published in a medical journal within two and a half years of the trial’s completion—with fully one-third of trial results remaining unpublished even four years after the trial. Why? Because the data didn’t tell the story that the drug manufacturers wanted. This of course distorts the view regarding the safety and effectiveness of drugs by only publicizing positive findings and burying negative findings. So if a drug is harmful or doesn’t work, you’ll probably never hear about it. Conversely, if results are negative or can be made negative for supplements—which Big Pharma considers its greatest competition—you will certainly hear about it.

Drug safety data is being kept from the public

One example cited in the study was the FDA-approved diabetes drug Avandia, which in 2007 was found to increase heart attacks and cardiovascular deaths—even though the drug’s maker, GlaxoSmithKline, had known about the risk before the drug was approved. The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.

For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing that the drug did not reduce buildup of fatty plaque in arteries as claimed. During that time, the drug was heavily marketed to consumers in TV ads for lowering LDL cholesterol. In 2008, after a congressional investigation was launched, Schering-Plough “voluntarily and temporarily” halted the ads, and no disciplinary action was taken by the FDA. Vytorin remains on the market as a cholesterol drug.

In 2003, a clinical trial of Multaq, a drug that treated cardiac arrhythmias, was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for atrial fibrillation in certain patients—despite the risk of death.

Scientific misconduct—even fraud—is being ignored

A recent investigation found that the FDA routinely hides important safety information when it uncovers scientific misconduct in clinical trials of pharmaceutical drugs. The agency conceals the names of the drugs and the company responsible for the misconduct, journal citations are left uncorrected, and claims made on drugs’ labels are left unchanged even after it’s known that they were based on bad science.

According to the author, “The FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware.” These aren’t isolated incidents, but part of routine behavior by the FDA to shield Big Pharma from unwelcome scrutiny.

Here are some highlights from the investigation:

  • Out of seventy-eight publications that sprang from a tainted study, only three cases mentioned the problems FDA found in the study.
  • Given 600 clinical trials in which a researcher failed an FDA inspection, in only 100 cases could investigators determine which drug and which pharmaceutical company were involved.
  • In the RECORD 4 drug trialsthat were used to establish the safety of the anti-blood-clotting drug rivaroxaban, FDA found rampant misconduct, including falsified data and fraud. “Yet,” writes the author, “if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.”

Unfortunately, we’ve seen this kind of thing before. Clearly, there’s a wide gap between what the FDA knows and what doctors and patients are allowed to know about the safety of prescription drugs. This is exaggerated further by publication bias—the tendency of positive results to be published over negative results—which can give doctors incomplete or misleading information about a drug’s safety.

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