Drug Safety "A Crapshoot"! - A recent article published in the Grand Rapids Press summarized the growing concern over the FDA's "speedy" drug-approval process due to the recent withdrawals of 5 products from the market, Duract, a non-narcotic pain killer, was withdrawn in June of 1998 because 4 patients died and 8 others required liver transplants after taking the drug. Redux and Fenfleuramine, both diet drugs, were withdrawn in September of 1997 because they were damaging hearts. Posicor, a blood pressure drug approved in August of 1997, was withdrawn in June 1998 after it was discovered that it causes deadly interactions with over 25 other medications. Seldane, an allergy medication, is no longer available for use after it was also found to interact lethally with a long list of other medications. Some proponents of this sped-up process argue that of course these things will happen - clinical trials are conducted on a mere few thousand people. Once approved, rare problems may not emerge until tens of thousands or more people actually take the drug. Medicines are tested to show the effect on average sufferers of a disease, not every individual. "It's a crapshoot," says George Poste, a chief science officer of drug company SmithKline Beecham. One long time FDA pharmacologist, Elizabeth Barbehenn, just left the agency after 13 of employment in frustration over increased pressure to skim over safety concerns. She said they gave the message that, "one should be approving things, not questioning problems that arise, and ... give the drug company the benefit of the doubt. Five drugs have been pulled off the market since September of 1997, and one pulled from review (due to potential lethal drug interactions) - in the previous 10 years, the FDA had banned just 6 other drugs. Source, Grand Rapids Press I July 12, 1998

Lack of Patient Information - A June 9 Reuters press release discussed the lack of up-to-date information provided in Patient Information Leaflets (PIL) handed out by pharmacists when a prescription is filled. Public Citizen, a consumer advocacy group filed a petition with the FDA to "recall immediately those PILs whose inaccurate information is likely to cause substantial harm if not corrected." The case cited as an example was a 7 year-old boy who died after he was prescribed more than 3 times the recommended dose of impramine - a drug used to treat ADHD. His parents did not know that he was suffering from side effects because the tremors and hallucinations that he was experiencing were not included in the leaflet. "False, incomplete, or out-of-date safety information is leading to needles drug-induced deaths," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, "Commercial information vendors, pharmacists, and drug companies are all responsible for the information in these leaflets, and the FDA has the legal authority to ensure that PILs do not mislead the public, but has failed to meet its responsibility."

Chiropractic First - Every year, two million Americans are hospitalized for drug reactions and 1 00, 000 die. Doctors are not required to report side effects to the FDA so it can warn the public, however, and many don't. The FDA has 80 employees to monitor more than 3,000 prescription medications, and has to upgrade safety warnings on more than 20 drugs every month. There are apparently many opportunities to have a drug slide through the system too quickly, with less-than-adequate information for the physicians and the consumers. This is compounded by a lack of effort being put into reporting possible side effects or interactions to provide the needed precautionary information. The FDA consistently denies that outside pressure influences drug-safety decisions, yet critics point out that it is the drug companies themselves who are paying the extra fees that have sped up the very process which eventually lands their products on pharmacist's shelves. When the very people who provide the therapies that keep conventional medicine going call what they do "a crapshoot", it is time to look for a better way. Chiropractic doctors do not "cure" - they hold the utmost respect for the body's ability to heal itself - all they do is provide the proper environment by removing subluxations. Remember, "Chiropractic first, drugs second, and surgery last."