HARVARD EXPERTS: The Myth of Safe & Effective Drugs: Why The FDA Cannot Be Trusted

FDA logo with pills


In an article soon to be published in a special issue of the Journal of Law, Medicine and Ethics (JLME) and coming from Harvard experts is an eye opener for those who blindly follow FDA guidelines thinking that will protect them and their loved ones from the harm that can come from prescription medications.

The article first alerting us to this new research comes from the Harvard Ethics blog of one of the three authors of the paper and is titled “Risky Drugs: Why The FDA Cannot Be Trusted” by Donald W. Light. He begins this article with some important points about this 35 page paper:

“A forthcoming article … presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.

“The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm,1 while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.”

Original article:http://www.ethics.harvard.edu/lab/blog/312-risky-drugs

Let me point out here that I believe that figure for deaths to be skewed because on our site at www.drugawareness.org we quote a 1995 study done by pharmacists alarmed by the high number of deaths due to prescription medications. They found that prescription drugs are the third, not forth, leading cause of death in America and that there are 200,000 deaths per year as a result as opposed to the later figure of only half that amount which figure they are using here.

Either way you count you can see how closely the death toll comes to the death toll at 9/11. Let me remind you that for only one week’s worth of deaths we are continuing to suffer every week since then as a result of prescription medications we went to war for a decade after 9/11! We need to demand our government take this information and do something about this tragic loss in our country! As you read more from this new article you will see how much they are playing a part in this problem though.

You can learn much from the title of the article about to be published “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.” The authors of the paper are:

Donald W. Light
Rowan University, School of Osteopathic Medicine; Harvard University – Edmond J. Safra Center for Ethics

Joel Lexchin
York University

Jonathan J. Darrow
Harvard Law School

Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013, Forthcoming

And the abstract will give you insight into what you will find:

“Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D [Research and Development] on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.”

The paper in its entirety can be found here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014

I believe it is quite clear that the reason 90% of new drugs out there are no more effective than those older drugs already on the market is that the pharmaceutical companies are continuously redesigning these drugs so that they can obtain new patents on them. Of course that is done in order to bring in more income because you can charge far more for patented drugs than you can unpatented drugs.

When you combine this information about 90% of drugs on the market being no more effective than older meds with the information we have posted on our site from Dr. John Ioannidis, who is the world’s leading expert on medical research, stating that 90% of medical research is basically bogus, it makes you question why anyone would want to risk using prescription medications at all!!

After reading the interview from the Atlantic Monthly article titled “Lies, Damn Lies, and Medical Science” with Dr. Ioannidis you have to ask yourself if you would not take your car to be fixed by a mechanic who is relying on information about the car that is 90% incorrect, why would you take your body or the body of your loved ones to a doctor who is relying on information that is 90% incorrect? At this point it would appear to me that the risk is far too great! But I leave you all this information to study and then to answer that question for yourself.

Here is the link to the interview with Dr. Ioannidis: http://www.drugawareness.org/lies-damned-lies-and-medical-science/

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

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FDA Appoved Drug

VERY FITTING WARNING!!! And it makes perfect sense because FDA approved drugs – given as the FDA has determined is a safe & effective manner to take the drugs – is the #3 leading cause of death in America! As the THIRD LEADING CAUSE OF DEATH properly prescribed prescription drugs have earned such a dire warning!!!!!!

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Lilly admits paying docs to peddle drugs – at what cost??

As part of a large government fine of $1.4 BILLION Eli Lilly, makers of Prozac, Cymbalta, Stratera, Cialis, etc. has begun to disclose payouts to doctors to peddle their wares/drugs. When you consider the long reaching damaging effects of that, you realize that the fine is nothing compared to the loss of lives that are the end result.
Let’s look at just a few facts:
1. The third leading cause of death in America is “properly prescribed (following FDA and AMA guidelines) prescription drugs. That does not count those taking these drugs “off label” or in higher amounts than recommended, etc., but only taking them as recommended by those who are suppose to know safest prescribing guidelines.

Eli Lilly and Co. paid Jacksonville-area doctors thousands of dollars as consultants to market drugs

Maker of Prozac and Cialis was forced to publish doctor names and compensation.

  • Story updated at 11:29 PM on Friday, Sep. 4, 2009

Drug companies routinely pay physicians as experts in the course of marketing their products. While legal, the practice is widely criticized as a conflict of interest that drives up drug costs.

One pharmaceutical company paid more than $76,000 to Jacksonville-area doctors and other medical providers in the first three months of this year.

That’s according to the first publicly released information to document the long-hidden financial ties between drug companies and doctors.

Eli Lilly and Co., the maker of Prozac, Cymbalta and Cialis, was forced to begin publishing the names and compensation of its paid consultants as part of a $1.4 billion settlement with the federal government last January.

Among the names that became public were those of several physicians practicing in the Jacksonville area. For the full story, including names of the physicians, see Sunday’s Business section of the Times-Union.


Wendell's picture

Dr.’s are as bad as politicians!

Submitted by Wendell on Fri. 9/4/2009 at 5:09 pmDr.’s are as bad as politicians!

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  • Dr’s Got To Make A Living Too

    Submitted by fearlessfan on Fri. 9/4/2009 at 9:05 pmYou shouldn’t blame the doctors, it’s the high dollar Pharmaceutical companies who are pushing the dough.   Anybody in their right mind would take it especially if its legal; too heck with ethics.

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  • It is all about ethics

    Submitted by rs471911 on Sat. 9/5/2009 at 10:50 am Recently I was in my doctor’s waiting room, 45 minutes past my scheduled appointment. During my wait I watched as 4 pharmaceutical reps, one after another, walked right in to see the doctor and peddle their drugs. The nurse said the doctor sees each rep personally. When I finally saw the doctor I asked if he saw more pharmaceutical reps or patients a day. He gets perks for prescribing their drugs. The scariest part was I heard him asking one of the reps for medical advice. He is no longer my doctor.

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  • I had the same thing happen to me six years ago///

    Submitted by Xenon on Sat. 9/5/2009 at 1:53 pmI also was waiting for a appointment for over 45 minutes and was shocked at the people walking in and out without signing in. Finally when i was checking out, three representatives were in the hallway laughing and talking with the Doctor and talking about a upcoming quail hunt, Montana hunting trip and a deep sea fishing trip at their expense, one female representative turned to me and handled me a pen, with pharmaceutical advertisement on it as i was trying to sign my check and said to me, “Just keep it, a sovernier.” Smiled perkily and turned back to the group and the Doctor.

    I have not been back since. I just wish integrity, honor, honesty and accountability would come back along with true patriotism for our country and it’s citizens. My age is showing…

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