Friday, May 23

Reevaluating Anti-Depressant Treatments

Philip Dawdy, blogger of Furious Seasons, wrote the cover story for the Willamette Week today, "Bitter Pill; A Portland doc flips on big pharma and reveals its “dirty little secret”".

It's a great article and Mr. Dawdy also has great coverage on his blog. Here are some excerpts from the article but for full coverage check out the links.

Ten percent of Americans—children, teens and adults—take antidepressants. Whether it’s Prozac, Paxil, Lexapro, Effexor or Cymbalta, 30 million of us take a pill daily in hopes it will keep dark moods at bay. Antidepressants are the most prescribed family of drugs in America, an $11.9 billion market in the U.S. in 2007.

In January, Erick Turner, a professor of psychiatry at Oregon Health & Science University and a clinician at the Portland VA Medical Center, shook up the medical community, provoked the pharmaceutical establishment and, perhaps, disappointed millions of depressed Americans. He published a paper in the New England Journal of Medicine that revealed antidepressants are not as effective as we’ve been led to believe. For years, he implied, pharmaceutical companies such as Pfizer (maker of Zoloft) and Forest Laboratories (Celexa and Lexapro) have vastly exaggerated the performance of their drugs.

Turner calls it the “dirty little secret” of the psychiatric world.

... more important for Turner is how his work has shaken up the industry and raised questions about the integrity of the pharmaceutical industry and the weakness of the federal regulatory agency that’s supposed to protect the public from drugs that are dangerous or ineffective. It has also had the effect of raising an uncomfortable question: If antidepressants don’t work that well, why are so many Americans taking them?

And this excerpt is a bit of history:

Depression didn’t just appear with the advent of Prozac in 1987. The condition has been known since ancient times, and is infamously difficult to treat. In modern times, the advances of psychoanalysis and psychotherapy did little to fend off what Winston Churchill once called the “black dog.” In the 1960s, two classes of antidepressants became available. Neither was particularly effective, and they were not widely used.

By the mid-1980s, however, researchers had hit upon the serotonin hypothesis of depression—too little of the chemical serotonin in the human brain leads to depression. New-generation drugs believed to boost serotonin levels could treat depression. The drugs were known as selective serotonin reuptake inhibitors, or SSRIs.

The first new-generation antidepressant to be sold in the U.S. was Prozac in 1987, manufactured by Eli Lilly. Lilly claimed Prozac not only worked, it was virtually free of side effects. The drug rocketed to blockbuster status. In 1990, a Prozac capsule appeared on the cover of Newsweek and was hailed as a “breakthrough drug.” A few years later, Kramer’s Listening to Prozac became a bestseller. The drug achieved iconic status in American culture in a way few drugs ever had before or have since. The message was clear: Take Prozac and beat the black dog to the ground.

Prozac was followed by Paxil and Zoloft, and a host of other new antidepressants such as Effexor and Wellbutrin, 12 new drugs in all. In 2007, 233 million prescriptions for antidepressants were written in the U.S., according to data-services company IMS Health, accounting for $11.9 billion in sales. So widely used are these drugs that a recent study found traces of Prozac in creekbed mud in Portland and a 2004 British study found traces of the same drug in the British water supply.

FDA requirements for drug approval:

The FDA requires that clinical trials—studies done on human test subjects—be done before the approval of a drug. These trials determine several things: what dose of a drug is safe, what dose creates an effect, what side effects crop up for patients. But the biggest question is efficacy: How well does the drug work compared to a placebo? Pharmaceutical companies often run as many as 10 clinical trials enlisting thousands of patients and costing tens of millions of dollars to find out just how much efficacy their drug possesses.

You’d think doctors and the public would be allowed to see the results of all these trials, but that’s often not the case. Only two clinical trials with positive results—meaning the drug performs better than a placebo—are required for FDA approval. It doesn’t matter if eight other studies show negative results. Typically, the two studies are published in peer-reviewed journals. The fate of any other pre-approval studies is left to the whims of the drug’s maker. There is no requirement that a pharmaceutical company make public all of its clinical trials.

and what is with Daniel Carlat's (assistant clinical professor of psychiatry, Tufts University School of Medicine) statement that physicians continue prescribing antidepressants even though they know them to not be effective, as they can't prescribe a sugar pill!!

"The fact is, we’re not allowed to prescribe placebos in our practices, and we have patients coming to us and banging down our doors because they are miserable,” says Carlat. “We can’t offer them a sugar pill, but we can offer an antidepressant even if its effect is 80 percent sugar pill. A lot of our patients are getting better. That’s why we prescribe antidepressants even in the face of this recurrent data.”

However, there is evidence that taking antidepressants can be harmful to some people’s health. In recent years, the FDA has mandated warnings on all antidepressants due to elevated risks of suicide and suicidal thinking in some people under the age of 25 who take the drugs. In addition, antidepressants can cause very intense withdrawal problems for some patients, most notably with Effexor and Paxil. The drugs can also cause internal agitation—akathisia—in some patients, and, tragically, antidepressant use sometimes has been connected, however peripherally, to school shootings, most famously at Columbine High School in 1999, where one of the shooters, Eric Harris, had been taking Luvox.

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