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Let me introduce myself. My name is Mark Sisson. I’m 63 years young. I live and work in Malibu, California. In a past life I was a professional marathoner and triathlete. Now my life goal is to help 100 million people get healthy. I started this blog in 2006 to empower people to take full responsibility for their own health and enjoyment of life by investigating, discussing, and critically rethinking everything we’ve assumed to be true about health and wellness...

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August 16, 2008

Are New Prescription Drugs Safe?

By Worker Bee

Prescription DrugsIn the midst of the Primal Challenge and provocative issues like insect eating, 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. (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 “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. 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 Flickr Photo (CC)

Further Reading:

The Beginning of the End: Statins for Children

Deconstructing Healthcare in America – A Modest Proposal

Control Your Lifestyle, Control Your Genes

TAGS:  Big Pharma

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8 Comments on "Are New Prescription Drugs Safe?"


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Dave in Ohio
Dave in Ohio
8 years 2 months ago

I’d say we are all being fleeced, even those of us who don’t take prescription drugs. A classic case is statics, given to virtually anyone who has their cholesterol checked, and costs about $100 a month. That’s a lot of healthcare cost right there. Not to mention it does nothing to help for over 99% of those taking it, but does comes with a plate full of side effects that lowers the quality of life for the patient.

Dave in Ohio
Dave in Ohio
8 years 2 months ago

I meant “statins”, not “statics”, of course. Sorry for the error.

Methuselah - Pay Now Live Later

What drives me nuts is that since the pharmas have the money, they drive the reseach agenda. The wealth of information that collects on this and other blogs has very little impact on what research is done even though the likely impact on people’s lives could be greater than the impact of the bottom-line-drive research they do. More on that point here, if you are interested.

Pay Now Live Later

8 years 2 months ago
There are big problems with our drug development and approval process, but making harder and longer to approve drugs is going in the wrong direction. I Googled drug developement costs – according to the Congressional Office of Technology assessment it cost $359 Million to get a new drug approved. Newer figures place the cost upwards of $500 Million. And the process takes 8 to 12 years. And, only 1 out 5000 compounds that starts preclinical testing actually make it to market. We need to overhaul the way drugs are developed and brought to market – and not just add more… Read more »

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[…] ready? Let’s take this thing apart! First off, a bit of review. Some weeks ago we brought you perspective on the “harm-benefit” ratio in pharmaceutical testing. With the myriad of, say, cholesterol targeting drugs out there, you’d think that all that […]

6 years 3 months ago

DO away with drugs , and start fixing stuff with your mind! Whatever your mind can concieve will manifest. Meaning think healthy , and you’ll be healthy. It’s so simple its kind of mind boggling. Thanks..


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