Over the past weeks, we have learned that major companies that make products we trust, like Volkswagen's diesel engines and Takata's air bags, have rigged test results to make their products look cleaner and safer than they really are. Yet, far more widespread manipulation of test results is routinely done by pharmaceutical companies to get drugs approved by the U.S. Food and Drug Administration (FDA).

Virtually every pharmaceutical company has been rigging tests for years to make the drugs we take look safer than they really are. Some of the techniques are described in a recent assessment in the BMJ (formerly the British Medical Journal). They include tests that exclude older people, women, and people with multiple health problems who may be more likely to have adverse reactions.

Other techniques include using high doses in shorter trials to produce positive results before adverse reactions become evident.  FDA regulations also allow companies to run multiple trials and hand pick the most positive results.

Worse, unlike regulators for cars, planes, electronic devices and appliances, who work to detect and stop rigged testing, the FDA has long known about the ways companies bias trials.

This puts patients at serious risk.  Independent experts estimate that approximately 128,000 patients die each year from adverse responses to drugs that were properly prescribed. Another 2.7 million are hospitalized due to drug reactions.

Given the central importance of drugs in modern medicine, you would think the FDA would maintain a comprehensive tracking system to provide information on safety risks by drug. But it doesn't.

Perhaps the most famous safety failure was Vioxx, which Merck finally withdrew from the market - after years of obfuscation - after it was estimated to kill about as many people as soldiers who died in the Vietnam War.

Why does the FDA permit biased trials for safety and efficacy? Perhaps it has something to do with Congress underfunding the agency and then having companies fund the division that evaluates their drugs.

These practices subject patients to a double conflict of interest. First, companies test their own drugs, rather than having them tested independently. Then, companies pay the FDA a huge fee - $2,335,200 in 2015 - to review each drug. Highly trained and skilled staff work hard to do thorough reviews. But the reviews are on the companies' terms - their criteria, their trials, their data, their deadlines, their funded patient groups clamoring for approval, and their money.

While reviewers do turn down some drugs, 90 percent of the drugs that are approved are judged by independent experts to provide few or no clinical advantages over existing drugs.

Inadequate testing leads to predictable results. One in every five new drugs ends up causing enough serious harm to lead the FDA to require the most serious black box warning on the label, or to remove the drug entirely from the market - after the harm has been done.

This risk increases to one in three when reviews are accelerated under a special process, requiring even higher fees from drug makers.

And once a drug reaches the market, there is a third conflict of interest that endangers patients: the same FDA group that approves drugs is responsible for investigating evidence of harm after approval.  We need an independent watchdog to monitor ongoing patient safety.

Most important, as a public agency charged with protecting people from unsafe drugs, the FDA needs to be funded entirely by taxpayers. Drugs are now the fourth leading cause of death, tied with stroke. The FDA needs to stop contributing to this problem and help reduce the number of patients exposed to risks of serious harm.


Donald Light is a widely published expert on drug policy and a professor of comparative health policy at Rowan University School of Osteopathic Medicine.


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