The Alliance For Natural Health

The FDA Often Approves Drugs It Knows Are Dangerous


Even when pharmaceutical companies submit studies showing the danger of drugs, the FDA will likely approve them anyway. This fact has been proven over and over again by a steady stream of scientists fleeing the FDA for reneging on its mission to protect public health. These whistleblowers have revealed the frightening extent to which the FDA does the bidding of the drug industry, including approving drugs as safe when the evidence reveals them to be unsafe.

For example, Merck’s drug Vioxx was known to increase the risk of heart attack, yet the FDA approved it, which caused the death of 60,000 Americans and caused 140,000 heart attacks.

In a 2005 interview, Dr. David Graham, the epidemiologist and senior drug safety researcher at the FDA who was the whistleblower on the whole Vioxx scandal, spoke plainly about the FDA’s priorities in the drug approval process:

If the FDA were to pull a drug due to safety issues, it would hurt the marketing of the drug. It might also call into question why they approved the drug in the first place. Therefore, you get this culture of cover-up, this culture of suppression, this culture of denial, and this culture that demonstrates above all else that industry is the client and not the American people.

Unfortunately, the case of Vioxx is far from an isolated lapse in judgment, but rather reflects a frightening reality about who the FDA actually works for. The agency’s mishandling of Pradaxa, the blood thinner, is the stuff of legend:

  • The FDA knew there was no antidote to stop patients on the drug from hemorrhaging, but approved it anyway. Even more egregiously, the FDA has never required the manufacturer to carry a conspicuous “black box” warning about hemorrhage on Pradaxa.
  • The clinical trials were rife with errors, and doctors helping to oversee the trial were found to have mismanaged their part of it.
  • When adverse event reports about Pradaxa started mounting, the FDA issued statements defending the drug.
  • Members of the FDA advisory committee that unanimously endorsed Pradaxa had extensive ties to the pharmaceutical industry. Two went on to receive substantial compensation from the maker of Pradaxa.
  • The drug is also associated with a markedly higher risk of heart attacks and other acute coronary events.

In fact, many FDA-approved prescription drugs are later withdrawn from the market. According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.”

The problem, of course, is that drugs with devastating adverse effects and huge numbers of deaths routinely slip through the FDA’s supposed safety net in the first place. It is no surprise that FDA-approved drugs have a one-in-five chance of causing severe reactions after they have been approved—and those are just properly prescribed drugs. Dr. Donald Light, whose current research concerns the historical roots of institutional corruption in the development of prescription drugs and its consequences, writes that properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year, and about 128,000 people die from drugs prescribed to them—making pharmaceutical drugs the fourth leading cause of death.

As our FDA Death Meter demonstrates, between 2.5 and 12.7 million American citizens (using the most conservative underreporting) have been hospitalized or have died in the past ten years after receiving an FDA approved drug or vaccine.

For more examples of FDA drug approvals that resulted in disastrous numbers of adverse effects, see our list of Deadliest Drugs.