Drug Enquirer


Too Much of a Good Thing?

Black Box Warning is the strongest alert the FDA can require.
To make prescribing easy for doctors, drug-makers often produce simplistic—and therefore unnecessarily high—doses.

Millions of Americans are experiencing unnecessary adverse reactions, “ranging from dizziness and nausea all the way to death,” because drug-manufacturers' recommended doses are too high, states medical expert Jay S. Cohen, M.D., associate professor of family and preventative medicine at the University of California at San Diego, in his book, Over Dose: The Case Against the Drug Companies.

“For one in five drugs, dosages are ultimately lowered years after FDA approval—after millions of people have received the higher doses.”

ABOVE: Gale, K. “Drug Doses Frequently Change after Approval.” Reuters Health, Mar. 9, 2001

Aren't pharmaceutical companies concerned about adverse side-effects?

“Of course—to a point,” reports Dr. Cohen. “A drug company doesn't want a new drug to cause any more side effects than necessary. On the other hand, getting a drug to market quickly, before its competitors, is often worth billions and proves far more important to drug companies than determining the very best and safest doses for patients.”

Dr. Cohen's important book, Over Dose, explains in specific detail how and why drug companies create unnecessarily high doses.

“Drug-company ads typically promote expensive brand-name products although other drugs may be equally effective, more extensively studied, and less costly.”

ABOVE: Cohen, J.S. Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health. New York: Penguin Putnam Inc., 2001.

Higher Doses Produce Maximum Effectiveness

Drug makers use “the highest-possible dose” to convince the FDA that their new drug works (citing Dr. Woosley in Drug Therapy).

“It's the regulatory [FDA] requirement to demonstrate efficacy that drives higher doses” (citing associate vice president for the Pharmaceutical Research & Manufacturers of America).

But the FDA doesn't prevent drug companies from researching and producing lower doses.

Limited Doses are Cheaper, Quicker and Easier for both Drug-Makers and Doctors

Dr. Cohen explains the obvious: “Limited doses are quicker and easier to research, cheaper to produce, and easier to market, requiring fewer guidelines and fewer pill sizes.”

Simplistic dosaging helps busy doctors, too. “Doctors like drugs that come in a one-size-fits-all dose,” so, “if a pharmaceutical company makes it the least bit complicated for them, they'll often choose another drug that's simpler to use.”

Take Charge of Your Health

What is the solution? While improvements can and should be made in our system of approving new drugs and their doses, the most important person in protecting your health is YOU.

“Having blind faith in your doctor and the medical system puts you in a precarious situation. Trust must be earned, not expected.”

ABOVE: Strand, R.D. Death by Prescription: The Shocking Truth Behind an Overmedicated Nation. Nashville: Thomas Nelson Publishers, 2003.

“Don't expect the FDA, your doctor, or anyone else to take full responsibility for your greatest natural resource—your health,” advises medical expert, Dr. Ray Strand, M.D., in his book on this subject, Death By Prescription: The Shocking Truth Behind an Overmedicated Nation. “You must become the chief guardian of your health,” Dr. Strand advises, by becoming actively involved in your own treatment.

Many drug reactions are preventable if you learn to ask the right questions to your doctor and pharmacist, as discussed next, see: “Stop Side Effects Before They Start.”

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