The next Vioxx scandal has now landed on the FDA’s plate. A
secret tip to the FDA forced Bayer to admit they had failed to
disclose serious safety data. Bayer scientists recently
testified before an FDA advisory panel investigating the
company’s heart-surgery drug, Trasylol. They failed to mention
a new study Bayer commissioned for the drug, one that contained
highly unfavorable results. On Friday September 29, 2006, the
FDA, stung by the blatant deception,
announced to the world that Bayer hid safety data during the
FDA investigation. The FDA reported that the new data showed an
“increased risk for death, kidney
failure, congestive heart failure and stroke,” yet the FDA
failed to pull the drug from the market.
As the crisis unfolds the FDA is doing virtually
nothing to protect Americans from the drug (most
don’t even know when they get it). The FDA
strategy is to attempt to protect itself from
the soon to be unleashed attack on their
ineptitude, as well as to protect Bayer as best
they can from a flood of lawsuits. A recent
Institute
of Medicine report describes the FDA as
having a dysfunctional organizational culture
wherein the FDA and Big Pharma hide relevant
safety data from the public. The FDA cannot be
trusted and drug companies can be trusted even
less.
Andrew von Eschenbach, temporary head of the FDA, is
demonstrating a lack of leadership in crisis. If he pulls the
drug off the market it will imply guilt that will be used in
courts across the U.S. Von Eschenbach is known as
a
leader who wants even fewer safeguards on drugs. He is a
man with a long and profitable Big Pharma friendship. He would
rather help Bayer deflect lawsuits than take effective action to
protect the safety of Americans. He is attempting to use the
time-honored method called partial admission to escape
taking responsibility. The FDA admits there might be a serious
problem, but says the problem could be caused by something
else. The idea is to stall for time, slow down the flood of
inevitable lawsuits, and hope the crisis goes away. Von
Eschenbach is up for Senate confirmation. So far he has had a
free ride, as no Senators have asked tough questions on the real
issues.
Yes, von Eschenbach is on a volcanic hot seat. Keep in mind
that
under von Eschenbach’s leadership the FDA has asserted that
no American citizen should be able to sue a drug company once
the FDA approves a drug. If von Eschenbach had his way, Bayer
would be immune from all lawsuits related to Trasylol. Explain
that to the families of the Americans who have been killed and
the thousands of Americans that need dialysis every year due to
Trasylol-induced kidney failure. The FDA wants you to trust
their competence to determine which drugs are safe, do you?
Trasylol
On September 30, 2006, the
New York Times reported that the FDA learned of a secret
Trasylol study due to a tip coming from a researcher involved,
not from Bayer. Trasylol has been
under scrutiny all year based on several reports of serious
side effects, one published in the New England Journal of
Medicine.
On September 21, 2006, an FDA
advisory panel disagreed with the conclusions of the studies
and stated that Trasylol was safe and effective. Bayer withheld
from the FDA and the advisory panel that they had commissioned
an independent study, that they possessed the results of the
study, and that the results were highly unfavorable to the
drug. Certainly, if the results had even been remotely
positive, Bayer would have been waving the study in front of the
advisory panel.
Trasylol is used to prevent excessive bleeding during coronary
bypass surgery. There are less expensive drug options that do
not contain the risks of Trasylol.
Most patients do not
know they are getting the drug as it is administered
intravenously with other medications.
The new Bayer-sponsored study examined the
hospital records of 67,000 patients.
37,000 had received less expensive drugs, while 30,000 received
Trasylol. Trasylol users were clearly at greater risk for death
and kidney failure, prompting the FDA alert. This supports the
earlier New England Journal of Medicine report that
warned of double the risk of kidney failure from the drug. That
study concluded that we could save 250 million in drug costs and
1 billion in dialysis costs by preventing 10,000 – 11,000 cases
of unnecessary kidney failure.
The FDA has moved at a snail’s
pace while sales of this dangerous medication were expected to
triple in 2006. In 2005 one hundred and fifty thousand
Americans were exposed to this drug. It is likely that
significantly more Americans were exposed to it already this
year, while the FDA failed to act in an expeditious or effective
manner to protect the consumer public from serious drug harm.
Bayer obviously stood to lose the profits of an emerging
blockbuster drug if they disclosed the adverse safety
information. When confronted on the deception Bayer issued a
statement saying that the failure to disclose the information
was “a
mistake on the company’s part.”
A Brief History of Bayer
During WWII the chief executive of Bayer, Fritz ter Meer, ran
the Auschwitz concentration camps. He oversaw the use of slave
labor to churn out war resources for the Nazis and was the
ranking administrative official that oversaw the slaughter of
millions of Jews. Following the war he and other executives
were given “white collar crime” punishment, and were soon freed
from jail by Rockefeller-backed interests that had actually made
the war possible by supplying the Nazis with a special fuel
additive needed to fly their planes. Within a decade of
completion of WWII Fritz ter Meer was back at the helm of
Bayer. I fully explain this sordid history in my book, Fight
for Your Health: Exposing the FDA’s Betrayal of America.
While many examples of Big Pharma disregard for life in the name
of profit exist, two are worth mentioning. Bayer sold an
HIV-tainted blood product to hemophiliacs in the United States. When
the FDA finally made them quit doing so, Bayer continued to sell
the HIV-tainted blood product around the world, even producing more of
it. All the while the FDA helped hide the problem from Congress
and the American public. This scandal was detailed in a 2003
New York Times article. Bayer paid out over 600 million
dollars in damages, while admitting no wrongdoing.
In another example, Bayer pushed to increase the dose of its
cholesterol lowering drug, Baycol, so it could more effectively
compete with other statin drugs. It did this even though it
knew the higher dose was harmful to human health, information it
withheld from the FDA. As Americans began dying from higher
doses of Baycol, the Bayer agreed to voluntarily pull the drug off the market.
Bayer has paid out over 1 billion dollars in damages for
Baycol-related lawsuits.
Who Is Responsible?
Bayer would like us to believe that the Trasylol cover-up is a
mistake. Bayer has a history of disregard for human health in
the name of profit. I believe it warrants a full Congressional
inquiry. What did Bayer know exactly and when? Why did Bayer
deceive the advisory panel and the FDA? Why has the FDA moved
so slowly while hundreds of thousands of Americans were placed
at risk? In the face of a crisis, why is the FDA playing a
stalling game? Does the FDA have the right to let Americans die
while it ponders, in a lackadaisical and inefficient manner, the
safety of a dangerous drug? Is this how von Eschenbach plans to
lead the FDA? Is the FDA hoping that Bayer will pull Trasylol
like Merck pulled Vioxx? Why doesn’t the FDA have the guts to
take a hot-selling drug off the market?
It is high time drug companies who withhold safety data are held
responsible for injuries and deaths that are associated with
their drugs and products. It is unlikely drug company
executives would hide safety data if they knew they would be
criminally accountable.
The Trasylol example is a symptom of the disease that permeates the
FDA, a disease that is bought and paid for by Big Pharma. Will
Congressional leaders act or are their hands also too deep in
the Big Pharma cookie jar? Yes, Congress is now on leave
preparing for the coming elections. Big Pharma continues to be
the leading source of Congressional lobbying money. After the
elections there will be favors to repay. Americans on drugs
should be running for cover.
© 2006
Truth in Wellness, LLC - All Rights Reserved
Byron J.
Richards, Founder/Director of
Wellness Resources, is a Board-Certified
Clinical Nutritionist and nationally-renowned
health expert, radio personality, educator, and
author.
Richards
encourages individuals to take charge of their
health, stand up for their health rights, and
not blindly succumb to propaganda from the
vested-interests who profit from keeping
Americans sick. Author of
Mastering Leptin and
Fight for Your Health, Richards is now
joining forces with
health freedom leaders in the U.S. and
throughout the world. Visit his
health blog for up to date happenings.
www.truthinwellness.com
As founder of
Wellness Resources, Inc. of Minneapolis, MN
(since 1985), he has personally developed 75
unique nutraceutical-grade nutritional formulas.
www.wellnessresources.com
Charter Member of
the
International and American Associations of
Clinical Nutritionists (IAACN) (since 1991)
Richards has presented hundreds of educational
classes to health professionals and individuals
who want to take charge of their health!
E-mail: byron@truthinwellness.com
