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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