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

FDA logo with pills

HARVARD EXPERTS: THE MYTH OF SAFE & EFFECTIVE DRUGS: WHY THE FDA CANNOT BE TRUSTED

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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ANTIDEPRESSANTS ARE FAR FROM ALONE IN DANGERS! & BEWARE OF DRUG ADVERTIZING!

NOTE FROM Ann Blake-Tracy (www.drugawareness.org):
The following article on drug advertising, “Side Effects Include Denial” is an
EXCELLENT article on how the public is brainwashed into using drugs without a
thought. This is how we have ended up on all of these new “Designer Drugs” that
seem to be more the norm in our society now than the abnormal. When I was
growing up someone who was ill was out of the ordinary. Most we well. Now it
seems the exact opposite with even the very young discussing their serious
disorders – things we never saw in children before.

Although our site has focused on antidepressants for many
years, that focus has nothing to do with lack of concern over a myriad
of other deadly medications. The focus on antidepressants has been due to
the extremely widespread use of these drugs along with their potential to lead
the user to extreme out of character violence toward themselves or others
coupled with their potential to lead to many other drugs being prescribed for
the antidepressant side effects they suffer (new symptoms such as a
diagnosis for Psychosis or Bipolar Disorder, Panic or Anxiety attacks,
extreme insomnia, sleep apnea and other sleep disorders, Restless Leg Syndrome,
alcohol or nicotine use/abuse, diabetes, Fibromyalgia, thyroid problems,
headaches, IBS, MS, Chronic Fatigue Syndrome, ADHD, etc., etc., etc.)
Many of the newer medications out there were designed specifically for the
increase in patients with these “symptoms” that are nothing more than
antidepressant side effects which would subside upon the safe withdrawal of the
individual from the offending medication – the antidepressant. And far too many

of these new drugs are just remakes of antidepressantsfar too similar in
action to these drugs. One example would be Chantix’ similarity to Zoloft.
Sarafem, prescribed for PMS, is nothing more than Prozac with a new name and
different color capsule (pink to give it a feminine touch). Duloxetine
is the chemical name for Lilly’s Cymbalta and the name generally given to a
patient prescribed the drug for urinary incontinence so that they
remain unaware that it is really an antidepressant (antidepressants have LONG
been given to children for bed wetting). Yet another antidepressant is
prescribed for tuberculosis. Then there are all of the headache medications and
too many pain killers which all have serotonergic effects and can cause many of

the same serious adverse reactions that antidepressants cause.

WE URGE YOU TO USE EXTEME CAUTION, NO MATTER THE DRUG PRESCRIBED!!!
PRESCRIPTION DRUGS ARE KILLING FAR MORE NATIONWIDE THAN ILLEGAL DRUGS!! READ
ANYTHING AND EVERYTHING BEFORE EVER PUTTING A DRUG IN YOUR MOUTH!!! INSIST ON A
PACKAGE INSERT RATHER THAN THE SHORT HANDOUT ON THE DRUG PROVIDED BY THE
PHARMACACY WHCIH DOES NOT EVEN SCRATCH THE SURFACE IN GIVING YOU THE TRUE
WARNINGS REFLECTED IN THE PACKAGE INSERTS.
__________________________________________
But last July the Food and Drug Administration, which approved Chantix in
2006, said it had received 4,762 reports of “serious psychiatric events” —
including paranoia, homicidal thoughts, hallucinations, 188 attempted suicides
and 98 suicides — and it ordered Pfizer to put a “black box” warning on the
drug.
Pfizer’s not worried for the same reason that Bristol-Myers Squibb isn’t
worried about its Abilify ad, with piano music under, showing a happy family’s
outing to a pier, accompanied by a voiceover about seizures, thoughts of
suicide, risk of death or stroke. It’s why Sanofi-aventis, the manufacturer of
Ambien, doesn’t mind spending half an ad (sleeping lady, rooster, harp) warning
of side-effects like sleep-driving and sleep-eating. And it’s why
GlaxoSmithKline is unconcerned about undercutting the effectiveness of its Requip ad

for Restless Leg Syndrome (relaxing lady, crossword puzzle, strings) with
warnings about (this is my favorite) compulsive gambling.

http://www.huffingtonpost.com/marty-kaplan/side-effects-include-deni_b_463996.html

Marty Kaplan

Director, Norman Lear Center and Professor at the USC
Annenberg School
Posted: February 16, 2010 12:31 PM

Side
Effects Include Denial

Why would Pfizer spend $100 million on two-minute TV ads that use a minute of
that time admitting that their drug Chantix can cause “changes in behavior,
hostility, agitation, depressed mood,” “weird, unusual or strange dreams,” and
“suicidal thoughts or actions”?

Because they have to, and because it doesn’t matter.

With the patent on Pfizer’s cash cow Lipitor expiring next year, Chantix, a
smoking cessation pill, had been one of their big hopes for the future. Chantix
sales in 2007 approached $900 million; by 2009, it accounted for 90 percent of
smoking cessation prescriptions. But last July the Food and Drug Administration,
which approved Chantix in 2006, said it had received 4,762 reports of “serious
psychiatric events” — including paranoia, homicidal thoughts, hallucinations,
188 attempted suicides and 98 suicides — and it ordered Pfizer to put a “black
box” warning on the drug.

What to do? One tack Pfizer took was to launch a “help-seeking ad” that’s now running all over cable TV. You might easily mistake it
for a public service ad. As a voiceover reads sentences appearing on a black
screen, a match-flame turns the words to smoke: “You wanted to quit before you
got married… You wanted to quit before you turned thirty-five. You wanted to
quit when you had your first child.”

At the end, you’re invited to go to MyTimeToQuit.com, which takes you not to
the Surgeon-General or to the American Cancer Society, but to a Pfizer site that
in turn leads you to Chantix. There’s no legal requirement to include the
suicide warning on the faux-PSA, because it never mentions Chantix by name.

Pfizer’s other marketing tactic was to air a testimonial. We spend two
minutes getting to know Robin, a real-life success story. In her kitchen, over a
lovely soundtrack, Robin tells us how Ben, one of her boys, asked her to stop
smoking. Her doctor prescribed Chantix. As she and her family walk around a
neighborhood of gracious lawns and fall foliage, we hear what good support and a
good drug can do. Back at home, her husband makes coffee while she slices apples
and cheese for a snack at the kitchen table. Radiant, laughing, she says that
Ben finally tired of counting the days since she quit. At the end, an
announcer’s voiceover invites us to “talk to your doctor to find out if
prescription Chantix is right for you.”

But wait a minute — literally. During half the ad, that same announcer is
also telling us about the mental health problems that can be worsened by
Chantix. Not once, but twice, he says what should be alarming words: agitation,
hostility, depressed mood, suicidal thoughts or actions. The words appear yet a
third time in the same ad, in a boxed text at the bottom of the screen.

Why isn’t Pfizer nuts to spend so much money scaring us to death about their
product? While Robin is slicing that apple, why isn’t Pfizer worried that the
voice warning about suicidal thoughts or actions will make us fret whether it’s
safe to let Robin be around sharp objects?

Pfizer’s not worried for the same reason that Bristol-Myers Squibb isn’t
worried about its Abilify ad, with piano music under, showing a happy family’s
outing to a pier, accompanied by a voiceover about seizures, thoughts of
suicide, risk of death or stroke. It’s why Sanofi-aventis, the manufacturer of

Ambien, doesn’t mind spending half an ad (sleeping lady, rooster, harp) warning
of side-effects like sleep-driving and sleep-eating. And it’s why
GlaxoSmithKline is unconcerned about undercutting the effectiveness of its Requip ad
for Restless Leg Syndrome (relaxing lady, crossword puzzle, strings) with
warnings about (this is my favorite) compulsive gambling.

Pictures are more powerful than words. Language and logic don’t have the kind
of immediate access to our brains that images and instruments do. Feeling comes
before thinking. We can be as skeptical about marketing as we like, but media
literacy isn’t much of a match for music. No wonder Plato banished the poet in

The Republic: he couldn’t think of a curriculum that could protect people from
being enthralled by fiction, spellbound by illusion. The bards who sang the
Homeric epics were the ancestors of today’s Mad Men.

Robin’s harmless kitchen knife brilliantly neuters the suicide warnings, as
does the rest of her happy-ending story. In 2005, Duke University researcher Ruth Day presented a study to the FDA demonstrating how ads
can use distracting images and music to minimize attention to risk warnings. Her
infamous example: the fast-fluttering wings of the Nasonex bee (voiced by
Antonio Banderas) prevented viewers from remembering the side effects
information. Partly as a result, last May the FDA issued draft regulations declaring that ads will be judged by their
net impression as a whole, not just whether they’re technically accurate.

Pfizer denies that increased regulatory oversight led them to
raise the time devoted to safety warnings in its Chantix ads from 14 seconds to
a minute. I suspect they could run a two-minute crawl about suicide risks, and
it still wouldn’t distract from Robin’s heartwarming testimonial. We’re suckers
for mini-movies. No wonder the corporations just unleashed by the Supreme Court
to spend unlimited funds on campaign ads are salivating at the opportunity to
enthrall us.

This is my column from The Jewish Journal of Greater Los Angeles.
You can read more of my columns here, and e-mail me there if you’d
like.

Follow Marty Kaplan on Twitter: www.twitter.com/martykaplan

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DR. IRVING KIRSCH: EXPLODING THE ANTIDEPRESSANT MYTH

http://reporter.mcgill.ca/2009/10/antidepressants-medical-boon-or-bust/

Home > Reporter

The
Reporter

McGill University | Montreal, Quebec |
Oct 09 2009

Antidepressants: medical boon or
bust?

The Biomedical Ethics Unit of the Faculty of Medicine is
proud to present Dr. Irving Kirsch who will deliver a lecture titled “The

Emperor’s New Drugs: Exploding the Antidepressant Myth,” on Oct. 14.

When asked about the subject matter of his lecture, Dr. Kirsch, a Psychology
professor at the University of Hull, in England, said this. “Antidepressants
work – everyone knows they do. That’s what I thought too, until my colleagues
and I analyzed the clinical trial data. When I obtained the unpublished as well
as published data from the Food and Drug Administration, I found that what
everyone knew about antidepressants was wrong. Instead of treating depression
with drugs, we’ve been treating it with suggestion. A thorough review of the

research demonstrates that the chemical imbalance theory of depression is wrong.
The effect of antidepressant drugs is independent of their chemical composition.
Depression can be treated more effectively and more safely without drugs.”

The Emperor’s New Drugs; Oct. 14; 12:30 – 1:30 p.m. 3647 Peel St., room
101. Lecture is free, all are welcome. For more information contact Audrey M.
Prosser at 514-398-6980 or by email at

audrey.prosser@mcgill.ca.

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4/14/2000 – Safety Study Skimping?

This article appeared yesterday on the ABC News site. We know
that drugs are given only cursory tests before being introduced
into the marketplace. Pharmaceuticals counter that they do
extensive follow-up testing (post-marketing) to assure that the
drugs are in fact safe. Now, it appears that this is something to
which they only give lip service. Mark

http://abcnews.go.com/onair/WorldNewsTonight/wnt_000413_fd
a_feature.html

Report Says Drug Companies Fail to Complete Required Tests
When the Food and Drug Administration approves a drug it may
still have lingering questions about its safety or effectiveness
which it expects will be answered by the drug company.
(ABCNEWS.com)

By John McKenzie

N E W Y O R K, April 13 Evidence gathered by an
independent advocacy group suggests that many drug
companies in the United States are not keeping all of their
promises.

When a drug is approved by the Food and Drug Administration,
pharmaceutical firms are required to fulfill “post-marketing”
commitments to continue studying the safety and effectiveness
of the new product. Such research is necessary because the
FDA often approves drugs that have been tested on only a few
thousand people and lingering questions may remain about
how the drugs interact with other medicines or foods and what
kinds of side effects they may create in various patients.

The new study indicates, however, that many companies
routinely fail to follow through with these studies after the new
drugs reach the market. And the FDA is virtually powerless to do
anything about their lack of compliance.

The group that issued the report, Public Citizen, presented the
evidence to the FDA today, based on information obtained
through the Freedom of Information Act.

“Reliance on post-marketing studies as a way of safely
approving drugs is a dumb idea,” says Dr. Sidney Wolfe of Public
Citizen. “And a very dangerous idea because the studies mainly
are not getting done.”

Non-Compliance, No Consequences

According to Wolfe and the other authors of the report, FDA files
reveal that five drugs that were approved in the past decade and
later withdrawn from the market for safety reasons never had all
of their required follow-up studies completed.

And as of last December, only 11 out of the 88 new drugs that
were approved with post-marketing commitments between 1990
and 1994, had been subjected to the necessary studies or
properly filed the results. That€ ‘²s a compliance rate of just 13
percent.

“Five to ten years is certainly more than enough for the
overwhelming majority of these studies to be completed,” says
Dr. Brian Strom of the University of Pennsylvania. “The longer it
takes to answer these questions the longer patients are
exposed to potentially unnecessary risks.”

FDA Lacks Power

Representatives for the drug industry, however, say such studies
require greater patience.

“Specific studies that have to be designed, executed’. and if
they’re done in a comprehensive way they take a long time
to
do,” says Wayne Pines, a pharmaceutical industry spokesman.

But while the FDA can tell the drug companies to conduct
additional post-marketing studies, the fact is that once a drug is
on the market there’s little it can do to enforce the order.

Consumer advocates say Congress needs to give the FDA the
authority to impose fines on drug companies that break their
promises.

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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.

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