Is the FDA Negligent?

Over the last twenty years, Americans appetite for prescription drugs has exploded.  One need only to turn on the TV to see ad after ad  suggesting that there is a pill to satisfy any pain, discomfort or ailment that you may encounter.  The message seems to be: “No need to work hard at anything or modify the way you live because we have a pill for it; whatever it is”.  But with the FDA looking out for the public welfare, isn’t that a safe proposition?

Well, let’s look at the facts.  Last year over half a million Americans suffered adverse events due to prescription medications.[1]  Almost 100,000 people die yearly as a result of complications from pharmaceutical drugs.[2]  To be sure, the FDA is under pressure to approve drugs faster, and they undoubtedly are under-staffed to review the $2.5 trillion worth of foods, drugs and medical devices they are currently responsible to oversee.[3]  But ultimately, it is the American consumer that gets hurt; and the pharmaceutical industry that lines its pockets with billions of dollars in the process.

In 1992 Congress passed the Prescription Drug User Fee Act, ostensibly to provide the FDA with desperately needed funds to make it more efficient.  The idea was to shift some of the cost of research involved in drug approvals to the pharmaceutical companies.   It essentially allows the drug makers to pay a fee to the FDA to approve their drugs.  This year, that user fee is estimated to be $920 million; nearly one third of the FDA budget![4]

Does that fee unduly influence FDA decisions?  It is hard to imagine that it wouldn’t.  The agency entrusted to regulate the pharmaceutical industry is now financially dependent on that same industry for funding.  Dr. David Graham, a senior drug safety researcher at the FDA who was pivotal in having Vioxx removed from the market was quoted as saying: “As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that’s the way the FDA is currently structured.”[5]

Is there any evidence to back-up that claim?  Well, in the 40 years preceding the Prescription Drug User Fee Act, the FDA only recalled 8 medications it had previously approved.  Since 1992, that number is more than 22 drugs, and climbing.[6]  The latest drug casualty is Meridia, a weight loss drug pulled from the US market by its maker, Abbott Labs because it increases the risks for heart attacks, strokes and death.[7]  This isn’t the first weight loss drug to cause serious cardiovascular complications; remember Fen Phen and Redux?[8]  At least this time, the FDA eventually got it right by recommending Meridia’s removal from the US market.  It is troubling that European regulators banned it more than nine months ago.   What was the delay?  John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, suggested we need more weight loss drugs, “We’re still very committed to working with (manufacturers) to help them to develop and gain approval of safe and effective drugs to help patients manage weight”[9]

Last month I reported on the cardiovascular issues resulting in tens of thousands of deaths attributed to the diabetes drug Avandia.  It was banned in Europe but remains available in the US, albeit with tighter restrictions.[10]   There was a concern that diabetics would have fewer medication choices.  Really?  Type-2 diabetes can largely be prevented and reversed through lifestyle modifications.  But that approach would hinder profits.

Theses are just a few of the drug problems we know about.  More are likely to be recalled under the current approval system, and many remain on the market with dubious scientific benefit.  They continue to be prescribed in large part due to the weight of the pharmaceutical industry’s marketing initiatives to both physicians and the general public.  That is not to say that all pharmaceutical drugs are harmful.  Quite the contrary, there are tremendous life-saving medications available when needed.  But, many of the chronic conditions for which they are prescribed are preventable.

You may not hear that from big-pharma’s advertising, because it is much more profitable to treat symptoms with expensive drugs than to make you aware of the range of natural alternatives to prevent illness. Eat real food, not processed foods laden with chemicals and preservatives. Avoid sugars, starches and processed grains.  Drink more water.  Take high quality nutritional supplements; unlike pharmaceutical drugs, there are no widespread reports of deaths from vitamins.[11]  Exercise vigorously and regularly; it is the fountain of youth.  Get enough sleep to recharge and revitalize yourself daily; 7-9 hours are needed.  Learn to manage stress, enjoy more of your life, and keep things in proper perspective.

 Help is there but you must seek it out and make a commitment to the lifestyle changes necessary.  How do you want to live your life 10, 20, 30 years or more from now?  You can’t wait until then to decide.  What you do now will determine whether you remain vital, healthy and engaged in your later years, or whether you will be frail, feeble and drooling on yourself in a nursing home waiting for someone to change your diaper.  Which is your future vision?


[1] Quarter Watch 2009,” Inst. For Safe Med Prc. June 17, 2010; Retrieved Sept. 30, 2010 from http://www.ismp.org/quarterwatch/2009Q4.pdf

[2] Moore, Thomas J., AB; Cohen, Michael R., RPh, MS, ScD; Furberg, Curt D., MD, PhD., “Serious Adverse Drug Events Reported to the Food and Drug Admin.,” Arch Intern Med. 2007; 167(16): 1752-1759

[3] Gardiner, Harris, “The Safety Gap,” New York Times Magazine Nov. 2, 2008

[4] Zajac, Andrew, “Freeze? What Freeze? FDA in Line for Another Budget Boost,” Los Angeles Times Feb. 2, 2010

[5] Loudon, Manette, “The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower,” Organic Consumers Association Aug. 30, 2005

[6] Center for Drug Evaluation and Research Report to the Nation 2005: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/UCM078935.pdf

[7] James W, Caterson I, et al.  Effects of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects. N Engl J Med 2010; 363:905-917. Sept 2010. 

[8]Curfman G, Morrissey S, Drazen J.  Sibutramine – Another Flawed Diet Pill. N Engl J Med 2010; 363:972-974 Sept 2010.

[9] Abbott Withdraws Sibutramine from Market. http://www.medscape.com/viewarticle/730155

 [10] 47,000Deaths and Counting. http://alternityhealthcare.com/2010/09/25/47000-deaths-and-counting/

[11] “No Deaths from Vitamins, Minerals, Amino Acids or Herbs,” Orthomolecular Medicine News Service Jan. 19, 2010; http://www.orthomolecular.org

5 Responses to “Is the FDA Negligent?”

Randall Wilkinson October 13, 2010 at 7:43 am #

I noticed the latest edition of Life Extension Foundations magazine has a Headline on its cover proclaims, “Anti-cancer Effects ofMetformin” and its back cover says, “A drug everyone should ask their doctor about” and says that virtually all aging individuals can benefit from it.

Is there seriously legitimate reason why almost, if not all aging folks should actually be asking their doctors about this? I never like to shoot something down out of hand, but it makes me suspicious when I see claims being made that everyone has a reason to be taking a pharmaceutical.

Jim Bankert October 13, 2010 at 9:08 am #

According to obesity expert Dr. Arya Sharma, Sibutramine/Meridia was entirely appropriate and helpful to prioperly screened patients, so it would seem to be a case of context vs. the drug being a death trap for all, at least according to his experienced take on that medication.

His blog also contains many othr posts on that medication and issues surrounding it.

drebanks October 15, 2010 at 1:16 pm #

You apparently did not read my post carefully. It would be overly simplistic and irresponsible to call Merida a “death trap for all”. Most drugs recalled have helped someone. The point is risk vs benefit. The SCOUT trial was the latest of several studies that concluded that the marginal weight loss benefit of Meridia did not offset the risk for serious cardiovascular complications, including heart attack and stroke in a population already at increased risk for cardiovascular disease. Many weight loss drugs have had similar fates. For a disease that is largely preventable by making lifestyle choices, it is hard to justify taking a drug with such serious potential side effects.

drebanks October 15, 2010 at 2:24 pm #

A recommendation for everyone to take any pharmaceutical sounds a little questionable to me. I haven’t read the article, but I suspect it may be an over simplification of some rather compelling scientific data. There is very good evidence that Alzheimere’s disease, Parkinsons’ disease and other neurodegenerative diseases have an underlying inflammatory cause. Stimulating a pathway called PPAR-gamma reduces production of inflammatory mediators. Certain drugs, specifically NSAID’s, Metformin and Actos play a role in activating that pathway. Most of the studies have been on cultured cells and mice, so it is a little premature to recommend it for people. But the anti-inflammatory route for treatment and prevention of neurodegeneraive diseases is very promising.

Lyman Hibberd January 16, 2011 at 7:51 am #

Wonderful information – keep it in that way

Leave a Reply