Dr. Cohen Debates the FDA: March 26, 2004
On Friday, March 26, Dr. Cohen debated Dr. Robert
Temple, the FDA's top medication expert and its Assistant Director for
the FDA Center for Drug Evaluation and Research, in Miami at the Annual
Meeting of the American Society for Clinical Pharmacology and Therapeutics
(ASCPT). This was the fourth Cohen-Temple debate, which began when Dr.
Cohen was the Keynote Speaker at the Annual Science Day of the FDA's Clinical
Pharmacology Division in November 2002.
The ASCPT is comprised of many of the world's
top pharmacologists from academia, government, and the drug industry.
Other speakers included Dr. William Lee, a world expert on liver toxicities
and a leader in the effort to increase the public's awareness of the dangers
of acetaminophen (Tylenol and similar products) when taken in excessive
doses or when people are unable to eat because of nausea from the flu
or other stomach-upsetting conditions. Dr. Larry Lesko, the Director of
the FDA's Clinical Pharmacology Division, spoke on the importance of identifying
the proper doses of new medications during early research. Dr. Ted Grasela
discussed new models for defining such doses during new drug research.
Dr. Temple and Dr. Cohen squared off on the issue
of the safety of current medications. Dr. Temple described the FDA's requirements
for the drug industry when it defines doses of new drugs. Dr. Temple showed
how progress has been made in this regard over the decades. He acknowledged
that in the past, some drugs were originally marketed at unnecessarily
high doses and agreed that lower doses of Prozac, such as 5 and 10 mg,
work for some patients. But overall he maintained that the current models
and regulations were more than adequate to ensure patients' safety.
Dr. Cohen disagreed. He displayed evidence that
many patients get excessively strong doses of cholesterol-lowering statins
such as Lipitor, Zocor, and Crestor, of antidepressants such as Prozac,
Zoloft, Paxil, Effexor, Serzone, and others, of anti-inflammatory drugs
such as Bextra, Celebrex, Vioxx, and Motrin, and of Premarin, Neurontin,
high blood pressure medications such as atenolol (Tenormin), pain medications
and dozens of others.
Dr. Cohen demonstrated how scores of medications
are marketed at the same strong doses for young or old, big or small,
healthy or frail. He showed that patients frequently get the very same
strong doses whether they are taking 10 other medications or none. He
displayed evidence that although all experts in geriatrics recommend much
lower medication doses for older patients, more and more drugs are introduced
at one-size-fits-all doses for frail seniors and healthy young adults.
Such methods, Cohen said, not only explain why
medication side effects cause more than 106,000 deaths and 1,000,000 hospitalizations
perennially, but also why so many patients are afraid to take medications
or quit treatment even when it is medically necessary. "All members
of the healthcare system -- patients, doctors, insurers, regulators, and
the drug industry -- are harmed when patients quit vital treatment,"
Dr. Cohen said. Currently, more than 50% of patients with elevated cholesterol
or high blood pressure quit treatment prematurely, leaving them vulnerable
to the devastating effects of cardiovascular disease.
"We must do a better job of individualizing
treatment so that every patient gets the amount of medication he/she needs
and no more. We must drop the current model of simplistic, expedient,
one-size-fits-all dosing that overmedicates millions of people for a precision-prescribing
model that quickly identifies patients at risk and provides lower, safer,
proven effective doses for them." Cohen added, "When I've done
radio shows, veterinarians and farmers call in and say, `We adjust doses
based on our animals' weight or age, so why don't we do the same for people?'
That's a good question that the FDA and drug industry has yet to answer."
Dr. Cohen ended by emphasizing that when drug
companies drop doses that are beneficial for 30% or 50% of the population,
they are denying patients their rights of informed consent. When information
about lower, safer doses is omitted from package inserts and the Physicians'
Desk Reference, doctors are denied vital information that could help patients
and prevent serious drug reactions. It is not the obligation or right
of the drug industry or FDA to preselect a couple of doses to cover an
entire diverse population, Cohen emphasized. Instead, it is their obligation
and responsibility to provide information about all doses shown to be
effective and to let doctors and patients select from these based on each
individual case.
Dr. Cohen offered a specific warning about the escalating
popularity of statin drugs. Readily acknowledging that statins help millions
of people, Dr. Cohen expressed concern that doctors have become so enamored
with statin drugs such as Lipitor, they are prescribing stronger and stronger
doses without warning patients about possible side effects. Moreover, although
aggressive therapy is indeed warranted for patients with heart attacks or
unstable angina, doctors are also treating patients with mild cholesterol
elevations and few risk factors with the same strong doses. If not stopped,
this excessive dosing will inevitably lead to the overmedication of millions,
drive millions of patients from needed treatment, and cause serious side effects
such as muscle degeneration, nerve injuries, and serious or lethal liver toxicities
that will cause another backlash against the drug industry. "It doesn't
take many bad stories to tarnish the reputation of a good drug. We can prevent
this problem by providing doctors with the information they need to treat
each patient with the proper amount of statin medication for his/her condition.
Doing so is in the best interests of everyone involved in healthcare."
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