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Are New Prescription Drugs Safe?

In the midst of the Primal Challenge [1] and provocative issues like insect eating [2], we?ve gotten away lately from our more ?salty? side, shall we say. Truth be told, we realized this week that we haven?t quite felt like ourselves. We couldn?t put our proverbial finger on it until the realization set in. It was time, we decided, for a good, healthy rant.

And rant-worthy material was readily available, we might add. Little surprise here: it targets Big Pharma [3]. (Ah, we?ve missed you, Big P.) This time we?re raising Cain about new research into the seemingly shoddy review and approval process for pharmaceutical drugs. The research report, which was presented at the American Sociological Association?s 103rd annual meeting this week, cited [4] ?fatal flaws in the way new drugs are tested and marketed.?

According to Donald Light, report author and Professor of Comparative Health Policy at the University of Medicine and Dentistry of New Jersey, the pharmaceutical process has undergone significant and troubling changes. In the shadow of a booming pharmaceutical industry, the FDA is absurdly underfunded. The agency, as Light points out, even depends on pharmaceutical industry funds for basic operation expenses such as staffing. As a result, Light says, the industry has applied pressure for quicker reviews. The expediting of the process has led to the marked increase in reported serious reactions as well as the application of so-called ?black box? warnings or even withdrawals. Many of these come after the drug has been on the market and used by thousands or even millions of people, sometimes for a few years.

Light also faults the design of drug trials themselves. Allowing companies to measure the efficacy of new pharmaceuticals against placebos instead of ?current approved drugs? has led to an onslaught of new drugs that are no better than those already on the market and a dangerous number of new formulations that actually are more harmful than beneficial. According to Light, ?[O]ne in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the [FDA].? Additionally, drug makers, Light argues, frequently stack the deck in their favor as they design studies by often assembling their ?sample from a healthier population atypical of patients who will actually take the drug, excluding people who are older, poorer or who have multiple health problems.? Light also says that the length of trials are often too short to recognize or assess long-term side effects of many drugs.

Light summarizes the increasingly risky state of pharmaceutical testing and review in the U.S. by reframing the industry?s rhetoric in what he believes are more accurate terms: ?Based on our current system, the designation of ‘safe and effective’ on today’s new drugs could be replaced with, ‘apparently safe based on incomplete information, and more effective than a placebo.??

In the spirit of the weekend, we?ll keep our comments short and sweet (O.K. ? maybe not so sweet.) We?ve tried to set the record straight in the past by saying we are unequivocally for drugs that can truly help people [5]. What gets our goat is the shoddy, unreliable testing processes and the growing plethora of ?blockbuster? (most of them lifestyle) drugs that do the same thing no better than pharmaceutical treatments already out there. Oh, and did we mention the smiling, family running on the beach ads that have helped encourage a pill-popping culture that doesn?t ask nearly enough questions of these companies that are making billions off of drugs that too often offer no more benefit but much more risk than simple and relatively inexpensive lifestyle changes. It?s one thing to know many people are being financially ?fleeced? by the industry, but quite another to know these same people are also put at life-threatening risk for the sake of a few extra months? profit.

Ah, deep breath?. Hits the spot every time! The floor is officially open: rants, raves, cheers, dissent, and thoughtful/humorous comments of all kinds welcome.

mtsofan [6] Flickr Photo (CC)

Further Reading:

The Beginning of the End: Statins for Children [7]

Deconstructing Healthcare in America – A Modest Proposal [8]

Control Your Lifestyle, Control Your Genes [9]