April 2004 vol

March 2005 Vol. 2 No. 3
are so many drugs being taken off the market
Death by Prescription
after being approved?” While researching and
writing my book Death by Prescription, I found a
lot of answers, and raised many concerns of my
I am a person of Faith, but not blind faith. When it own about the way drugs are being approved in comes to anything except God, I ask a lot of questions before I entrust myself to someone orsomething. Particularly when it comes toprescription drugs, I find myself asking more and The Great Clinical Trial—You
more questions. The answers I find continue toshake my confidence in the drug industry and the When the FDA first approves a medication for
Most people assume that the
use by the public, they know less than half of
prescription drugs they take are very safe,
the serious adverse drug reactions of that
thinking they having gone through rigorous
drug. That is a fact. They know less than half of
and thorough testing by the Food and Drug
the adverse drug reactions of a particular Administration. But is that the case? Is the
medication at the time that the drug is approved.
FDA doing its job in protecting the public from potentially harmful drugs? Understanding how the pharmaceutical industry prior to approval are FDA works might shake your faith a bit, as have relatively small and short-term. Once a drug is the recent events surrounding the drug Vioxx.
released onto the market, millions of scripts maybe written and less frequent; however, maybe On September 30, 2004, Merck withdrew their even more serious side effects may occur. There very popular Cox-2 inhibitor and arthritis is no way these pre-clinical trials can elicit all the medication Vioxx from the market. After years of potential problems that a drug may have. How do building controversy and concerns over safety, they find out the other half of these adverse drug Vioxx was pulled from the market because of solid reactions? The answer is very simple—YOU! evidence that the risk of heart attack and stroke
You are the “Great Clinical Trial.” You are the
doubled in patients who were taking Vioxx
“human guinea pigs” they use to discover
long-term. This set off an immediate flurry of
adverse reactions of the new drugs that are
concern within the media and medical community put on the market.
about the safety of other similar drugs likeCelebrex, Bextra, and Mobic. Hearings were Once a new drug is released to the public, there is started by the US Senate chaired by Senator a voluntary reporting system back to the FDA. As a doctor, if I observe an adverse drug reaction inone of my patients, I am not required to report this Immediately, the concerns spread to other drugs to the FDA. It is strictly voluntary. It’s not like the use of the anti-depressant drug Prozac in surprising that less than 1% of the adverse drug
children, which increases the risk of suicide, and reactions are ever reported back to the FDA.
the use of the cholesterol-lowering drug Crestor,which increases the risk of muscle and liver Even when adverse drug reactions are reported damage. The question everyone is asking is this: back to the FDA, they are given to a department “If the FDA is supposedly doing its job, why
that has absolutely no authority except to gather the data. Once enough red flags are raised about approved at an unprecedented rate, far more
the potential new risk of a drug that is already on quickly than at any time in the history of the
the market, they refer their concern back to the committee that originally approved the drug.
Normally, the only thing that happens is a new What is even more concerning is the fact that warning added to the package insert or drug label.
today over 50% of the FDA’s budget now
But it gets worse: In order to put new warnings
comes from the pharmaceutical companies via
on a drug, the FDA must get permission from
these “user fees.” The industry that the FDA is the company that makes the drug! In the case
supposed to be governing is now its primary of Vioxx, the FDA had wanted stronger warnings source of funds. The FDA has had a definite added to the drug label two years before this drug change in attitude. Instead of determining if a
was pulled from the market. However, this change drug should be approved, the FDA is now
concerned with how to get a drug approved
because Merck did not approve of this action.
and quickly.
This is a serious and obvious problem.
Furthermore, the “user fee” money can only be
Voluntary reporting and inefficient bureaucracy used for the approval process of new drugs.
keep dangerous drugs on the market too long, This raises major concerns about the safety of and many drugs that do stay on the market do so with warnings that don’t reflect the risks that have surveillance division of the FDA (the department been discovered as the drugs have been tested responsible for evaluating the seriousness of the adverse drug reactions after a drug has been
released to the public) has not had any significant
increase in funding. Therefore, more and more
The Deadly Partnership
drugs are being approved faster and faster,
which is placing a greater burden on an under-
But how do these questionable drugs make it on funded, under-staffed safety department.
the market in the first place? In 1992, under
pressure from the public and the pharmaceutical
industry, Congress passed the “drug user fee
The Vioxx Story
act” which required the pharmaceutical
companies to pay a fee to the FDA, which
Vioxx along with the other Cox-2 inhibitors would be used to help the FDA approve drugs
(Celebrex, Bextra, and Mobic) were heralded as a much faster. A pharmaceutical company actually
major breakthrough in the treatment of arthritis.
pays the FDA a “user fee” of $250,000 each timethey submit a New Drug Application to the FDA.
Prior to these drugs, most people turned to
This fee was to be used strictly to move this NSAIDS (non-steroidal anti-inflammatory
approval process along. Additional pressure in drugs) like Motrin and Aleve. These drugs block
this legislation forces the FDA to cooperate with both the Cox-2 and the Cox-1 enzymes in an the pharmaceutical industry to get their drugs attempt to decrease inflammation and improve the symptoms of arthritis. But Cox-1 enzymes arecritical in protecting the lining of the stomach.
The legislation has been effective. The time to inflammation in the joint; however, you also may average of 24 months down to 12 months. Fast- create a problem of decreasing the protective track drug approvals have dropped from 12 lining of the stomach, which can lead to bleeding months down to 6 months. Drugs are now being
from the stomach. In fact, the NSAIDS had been
shown to be responsible for over 100,000
thromboxane A2. These cause increased clotting admissions to the hospital each year in the US
due to abnormal platelet aggregation which can alone because of stomach bleeding. Over
cause a heart attack or stroke. Other side effects 16,000 of these patients actually died each
cause increased hardening of the arteries which, year as a result of this bleeding.
in turn, contributes to coronary artery disease.
Even the decrease in stomach bleeding has been That didn’t appear to be the case with Vioxx. The called into question with the Cox-2 inhibitors… Cox-2 inhibitors primarily blocked only the Cox-2 But we didn’t know any of that until they tested it enzymes and left the Cox-1 enzymes alone. As a result, they were initially shown to significantlydecrease the risk of bleeding from the stomach.
These newer Cox-2 inhibitors took the
Congressional hearings that the FDA’s failure to marketplace by storm and quickly became the
protect the public health in the case of Vioxx was most prescribed arthritis drugs in the world.
“a profound regulatory failure.” In the October
An estimated 80 million people had taken
21, 2004 New England Journal of Medicine, Dr.
Vioxx by the time it was withdrawn. Annual
Topol wrote a very strong editorial criticizing the sales of the drug exceeded $2.5 billion.
FDA’s role in never mandating a post-market trial
of Vioxx and similar Cox-2 inhibitors. Vioxx was
But shortly after Vioxx was released, a major never tested, after its release, to see if it really
study was reported in the Journal of the American was a serious risk for heart attacks and
Medical Association (2001). Serious evidence
strokes in spite of the mounting medical
was mounting that the patients who were
evidence that this was happening. Rather than
taking Vioxx had a significantly greater risk of
fund a study, Merck had spent millions of
having a heart attack or a stroke.1 The
dollars trying to convince physicians and the
evidence continued to grow, but the slowness of public that these concerns had absolutely no
the post-marketing surveillance division of the validity.
FDA kept the truth from getting out quickly, and ofcourse Vioxx was unwilling to place strongerwarnings on its product. As the system faltered, What to Do
millions continued to take the drug in good faith,too often learning the dangers the hard way. In Every drug has an inherent risk of producing the end, Dr. Graham, a senior official of the FDA’s Office of Drug Safety, estimated that since the
pharmacological effect by blocking certain normal introduction of Vioxx into the market in 1999,
enzymatic reaction or reactions to create a it has been responsible for an estimated
desired result. In the case of NSAIDS and Cox-2 88,000 to 140,000 excess cases of heart
inhibitors the result is decreased inflammation in attacks and strokes, many of which were fatal.
the joints. However, these same enzymaticreactions are necessary for other beneficial We know the problem now. If only the Cox-2 functions in the body. When they are blocked, it enzyme is blocked, there quickly becomes an can lead to very undesirable effects. In the case imbalance in the body between the Cox-2 and of NSAIDS, it can lead to stomach bleeding. In the Cox-1 enzymes. This leads to an increase in the case of Vioxx, it can lead to an increased risk of level of other inflammatory products called 1 Mukherjee D, Nissen SE, Topol EJ. “Risk of Finally, it was determined that risks involved in cardiovascular events associated with selective taking Vioxx were greater than the benefits.
Therefore Merck removed Vioxx from the market worldwide on September 30, 2004. Celebrex,
Bextra, and Mobic are now under increased
scrutiny because they potentially could have the
same problems as Vioxx. Again, thousands may
die taking these drugs for an illness that is never
life threatening.
At this point, I’m encouraging everyone to
switch to other arthritis medications which are
in the NSAID class. At least, we know that the
main problem they have is upper GI bleeding. If
you have to take Celebrex, Bextra or Mobic, I
would strongly recommend that you ask your
doctor if you could take a low dose aspirin (81
mg daily) along with it. This can at least
possibly reduce the increased risk of a heart
attack and stroke as further studies are finally
being done to determine the safety of these other
Cox-2 inhibitors.
In next month’s newsletter, I will discuss the
natural remedies that are available today
which can improve your arthritis. These
remedies have no side effects and require
only a little bit of faith to try.
If you are interested in finding out more about the
dangerous world of prescription drugs, go to my
web site ( and order your
personal copy of my book, Death by Prescription
(Thomas Nelson 2003). It is now in paperback
and is available for a cost of $12.95 plus shipping.
If you order 2 or more books, the price is $9.95
each plus shipping. Take advantage of this
special offer and learn how you can protect
yourself and your loved ones from being
injured or dying from the 3rd leading cause of
death in this country—adverse drug reactions.

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