Long-term testing requirement for psychiatric drugs abandoned due to Big Pharma pressure on the FDA

Sunday, December 04, 2005 by: Dani Veracity
Tags: psychiatric drugs, medical ethics, side effects

The bipolar medication lithium is so toxic that it often causes major kidney damage, yet most patients must use it for lifetime maintenance of manic-depressive disorder. Similarly, schizophrenics often spend lifetimes on neuroleptics with long-term side effects such as tardive dyskinesias, or uncontrollable movement of the face, tongue, lips and extremities.

The point here? Side effects almost always go hand-in-hand with taking a medication for a long duration in order to treat a chronic condition. With that in mind, it seems outrageous that on Oct. 25, 2005, a panel voted to defeat the FDA's proposal to extend pre-approval testing of psychiatric drugs from two short-term studies to six-month trials. In layman's terms, psychiatric drugs will not be tested for a long enough time to determine their safety for long-term use before they are approved. Now, they can be tested for as little as two weeks, then given the stamp of safety approval by the FDA after which they will be used for years, if not decades, on unsuspecting patients.

In a Sept. 26 memo, Dr. Thomas P. Laughren, acting director of the FDA's Division of Psychiatry Products, gave solid reasons for the FDA's desire to extend its required testing time. In fact, he begins the memo with a simple fact that makes the need for long-term testing clear: "Most psychiatric illnesses are chronic." He later goes on to explain that current short-term testing methods advocate stopping treatment of subjects who are responding to the drug after only a few weeks, something that would be considered "ethically questionable" in actual clinical treatment. In other words, real-world patients with mental disorders may have to stay on these drugs for months, years, decades and possibly even a lifetime, so why should clinical testing be limited to the short term?

The current short-term tests also present a problem for psychiatrists who are prescribing a newly-approved drug. As Dr. Laughren explains, "Since most treatment guidelines for chronic psychiatric illnesses recommend continuing patients for four to six months or longer after response during short-term treatment, clinicians have generally not had a sufficient evidence base (from pre-approval studies) to support what is the standard practice of drug treatment of psychiatric illnesses."

When a psychiatric drug first hits the market, prescribing physicians are largely left in the dark about treatment issues after a patient stays on the medication longer than the six to 12 weeks tested during approval trials. Yes, the FDA generally asks for longer-term studies to be completed after approval, but it can be years before this is done. During this time patients are put at risk for side effects that did not emerge in the short pre-approval studies.

How Big Pharma overrules the FDA

Though Dr. Laughren rightly petitioned for testing standards to change, Big Pharma once again flexed its muscles and defeated the FDA's acting director and other supporters of longer safety testing requirements. Pharmaceutical industry executives from Merck, Wyeth and Eli Lilly gathered with academic researchers and presented the 11-member Psychopharmacological Drugs Advisory Committee with 15 presentations, all against extending the duration of pre-approval trials to six months.

Their argument? According to Eli Lilly's David Michelson, executive director for neuroscience medical research, half of all patients switch psychiatric medications after three months of treatment, with the figure reaching as high as 70 percent after six months. According to this logic, conducting six-month pre-approval tests will not benefit enough psychiatric patients to warrant the policy change. In other words, Big Pharma is saying we should ignore the potential health risks posed to psychiatric patients who take these drugs on a long-term basis because they don't make up a large consumer group. This perspective is alarming in itself, but given the scandals surrounding Vioxx and other prescription drugs, it comes as no surprise.

The facts are clear: Mental illness is presently an epidemic in modern society, a result of our chronic malnutrition and ingestion of metabolic disruptors (ingredients that disrupt normal brain function, such as refined sugars, trans fatty acids, chemical sweeteners, artificial colors, etc.). According to statistics from the National Institute of Mental Health, about one in five American adults suffer from a diagnosable mental illness.

To make matters worse, our population's desire for "magic pill" solutions has made us look to chemical cures for nutritionally- and environmentally-based problems. Because of this trend, drugs that we don't fully understand are being prescribed to an ever-increasing percentage of our population. The long-term effects of this could be disastrous.

In this case, the FDA tried to take a positive step in protecting the public, but failed under the pressure from Big Pharma. It's now up to concerned consumers like you to make your voice heard. Tell the FDA that you want psychiatric medication adequately tested, no matter what Big Pharma says.

Works cited:

FDA Advisory Committee. "Committee Information: Psychopharmacologic Drugs Advisory Committee." 2005. http://fdaadvisorycommittee.com

Laughren, Thomas P., M.D. "Memorandum to Members, PDAC." 26 Sept. 2005. http://www.fda.gov

National Institute of Mental Health. "Statistics." 15 Sept. 2005. http://www.nimh.nih.gov

Vedantam, Shankar. "U.S. Alters Test Policy on Psychiatric Drugs." Washington Post. 26 Oct. 2005. http://www.washingtonpost.com