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!”

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!!!!!!

09/15/1999 – ABC News Report Thursday Evening

News Alert!

Catch it if you can. Part II of a series on SSRI drugs and their side
effects will be shown on Thursday evening (9/16) on ABC News with Peter

While we’re at it, here are two links to a couple other ABC News
Stories you may have missed.

Bad Reactions to Prescriptions a Leading Cause of Death
Double-Edged Sword of Drugs

Only 15 to 20 percent of doctors mention potential risks to patients
when writing prescriptions.

Dangerous Prescriptions
The Risks of Meddling With Doctors’ Drug Orders


7/02/1999 – Welcome to the Drug Awareness E-Mail Group

The International Coalition For Drug Awareness is a private, non-profit group of
physicians, researchers, journalists and concerned citizens. Our primary focus
is to address the world’s most pervasive and subtle drug problem – prescription
drugs. We are dedicated to educating the people of the world regarding the
potential harmful and life threatening short and long term effects of these
drugs. As the cause of an estimated 200,000 deaths per year in America, drug
reactions are now the third leading cause of death! The most dangerous period of
time for a drug is upon market introduction. At that point physicians and their
patients have information on adverse reactions present in the controlled
environment of a clinical trial, but are unaware of the potential adverse
reactions of these new drugs when dispensed to the general public. We feel there
is a need to track and report patient reactions more carefully and more rapidly
than what is presently being done, which should result in lower medical costs
for the patients and doctors as well. And also might begin to breech the gap
that is beginning to form between well-meaning doctors and maltreated patients.
By keeping prescribing physicians and their patients abreast of recent adverse
reaction reports we hope to cut the number of unnecessary deaths due to drug
reactions and interactions and lessen the number of malpractice suits filed
against physicians as a result of those reactions. Beyond this public education
process our intention is to serve as an watch dog group in relationship with the
FDA and equivalent organizations around the world, encouraging them to remove
drugs which demonstrate high numbers of dangerous adverse reactions and threaten
the public safety.