Health Alert 225
Dear Subscriber:
Recently, you’ve heard about toxic side effects not listed on drug labels. Now I have found reason to worry about honesty in reporting what the drug can actually do for you as well.
Because of current FDA rules, your doctor could give you a drug you shouldn’t be taking because of omitted data the drug maker intentionally stripped from the prescribing information. Today we’ll discuss how you can avoid this danger.
There is a huge loophole in FDA drug reporting rules. Let me explain. When a drug maker wants to expand the use of an existing drug, they submit their evidence and try to get FDA approval for the new use. Now say the FDA rejects the approval of the drug for this new use or new patient group. End of story, right? I’m afraid not.
The drug company can still publish their own studies on the drug for the new use without disclosing that the FDA rejected this new use. They do not have to disclose the failure on the label or in the package insert your doctor has come to rely on.1 These omissions can cause doctors to prescribe drugs for uses that are known by the FDA to be ineffective or risky.
Such was the case with the anti-fungal drug, Diflucan, for the treatment of ringworm in children. The FDA rejected the drug for ringworm use. They decided it was not effective and could cause liver damage.2 But a doctor reading the information on the package insert could not have known about these negative results. Because neither the FDA nor the drug company reported them.
Another serious case: You may have heard that we have recently learned that antidepressants drugs increase suicides among youth
. Yet Dr. Andrew Mosholder found that kids who took antidepressants had increased suicidal thoughts and actions last year! But we did not hear of the evidence until mid September of this year.3Why did we go a year before learning of this danger? Because youth were considered a new patient group.4 Neither the FDA nor the drug maker was required to disclose the results. So they covered up and tried to silence Dr. Mosholder. We now know that they stopped him from discussing the results at a public meeting last February.
A congressional investigation eventually exposed the truth. But how many unsuspecting doctors continued giving these dangerous drugs to their young patients?
The FDA vehemently denies it, but as more FDA employees rely on drug companies for their paychecks, I interpret this and many other incidences as evidence that the FDA’s principal clients are drug makers, not John and Jane Q. Public.
It’s up to you to learn everything you can about any drug before you use it. Don’t trust drug labels or package inserts to give you the full story. Especially if you receive a prescription for what you suspect is a new use. Here are some suggestions to help you get the information you need:
1. Always look for a natural remedy first. Use prescriptions only as a last resort.
2. Ask your doctor to explain why he thinks this drug is a good choice.
3. Think about getting a second opinion.
4. Ask if the drug company paid for the research.
5. Don’t rely on “one-study proof.”
6. Remember, it is your body and it is your right to refuse any prescription.
To Your Good Health,
Al Sears MD
Sources:
1. Barry Meier; Results of Drug Tests Can Mystify Doctors Through Omission; New York Times, July 21, 2004
2. Barry Meier; Results of Drug Tests Can Mystify Doctors Through Omission; New York Times, July 21, 2004
3. Lisa Richwine; US reviewer says pressured in antidepressant probe; Reuters Health, Sept. 23, 2004
4. Youth antidepressant use down due to risks: Medco; Reuters Health; Sept. 21, 2004