Recently, many popular drugs have been taken off the market for killing or injuring Americans. However, the Food and Drug Administration (FDA) claims that many of these deaths and injuries are occurring because doctors are ignoring safety warnings and prescribing them to the wrong patients.
Are Any New Drugs Safe?
A report on ABCNews.com bring up an interesting point. They state "the problems raise a bigger question: Should a savvy patient ever swallow a new medicine until it's been sold for a year? After all, that first year of sales often is when bad side effects are spotted."
"I sure wouldn't," says Dr. Raymond Woosley, a leading drug-safety expert and cardiologist at Georgetown University, according to the report. "I don't personally, and I don't usually prescribe it unless I have to."
Even the FDA commissioner Dr. Jane Henney urges consumers to be cautious and to question when your doctor wants to switch you to a brand-new drug. If the only reason for switching is "to give it a try", then that is not a good enough reason according to Dr. Henney.
Is the FDA approving new drugs too quickly? Recently, under pressure from various sources, the FDA has sped up the review process: Average review time for new drugs was 14.6 months in fiscal 2000, down from 34.3 months in 1993. Drugs deemed breakthroughs, and drugs whose makers pay special fees to FDA, can get a speedier six-month review.
Ignored Warnings
However, few of the recently banned drugs got this "fast-track" approval. Instead, some FDA scientists say the main problem was that doctors ignored or never read warning labels that could have prevented deaths.
If that doesn't change, "additional effective drugs are likely to be withdrawn, and some drugs may never become available in the first place," warned FDA drug chief Dr. Janet Woodcock in an unusual letter to doctors in the Journal of the American Medical Association (JAMA).
One of the additional problems is that new drugs are tested on only a few hundred to a few thousand patients, so no one knows just how many side effects will turn up when they're given to millions.
However, the FDA has just 82 workers tracking side effects once drugs are on the market. The US Congress has repeatedly refused additional funds to upgrade the program, which depends on doctors voluntarily reporting their patients' side effects, which is something that few of them are doing.
Once it spots a potential problem, the FDA often tries issuing warnings. However, they maintain the warnings only work if doctors pay attention to them and heed the warnings. Some examples:
Propulsid - For two years, FDA warned that prescribing it to people with kidney or heart disease, or those who take certain antibiotics or other pills, could cause lethal irregular heartbeats. Yet 80 deaths occurred. Rezulin - FDA's own scientists complained for months that patients didn't get tested for liver damage as warning labels required.
Dr. Sidney Wolfe of the consumer advocacy group Public Citizen says the cases show FDA should ban drugs faster because warnings don't work.
Why Aren't Doctors Paying Attention
There are several reasons proposed as to why doctors are not getting the message:
Doctors claim they lack time to read the pages of fine print They claim they can't remember all the warnings Most doctors learn about new drugs from pharmaceutical reps, unlikely to stress the risks of the products they are selling Although some computer systems can flag risky drugs or combination, even these systems can sometimes make errors, according to Dr. Woosley. Shortly before Propulsid's ban, he tested a highly touted pharmacists' system and found it allowed prescription of a deadly Propulsid-antibiotic mix.
Nor do those flyers many pharmacies hand out with prescriptions list all the side effects.
The FDA is currently discussing tougher measures, such as limiting early sales of new drugs or even restricting which drugs can be prescribed by which doctors.
ABCNews.com December 12, 2000
I really believe that when one factors in the physician's lack of appreciation of the true causes of disease, such as a proper diet, that they are the number ONE cause of disease. Lack of attention to diet and lifestyle changes are what contribute to the vast majority of the leading causes of death - heart disease, cancer, and diabetes.
Last week the author of the JAMA article on my home page, Dr. Barbara Starfield, MD, MPH (Distinguished Professor at The Johns Hopkins Medical Institutions) contacted me regarding a detail of her article that is posted on the site and she was in nearly full agreement with my contention that physicians are in fact the number one cause of death in this country. However, until we have a peer-reviewed article documenting this I will not change the home page headline.
What can you do to protect yourself? If you have to take a medicine for any reason, do NOT rely on your doctor being aware of the side effects or reasons why you should not take the drug. There is a HUGE chance he or she may not know an important fact that could lead to a serious, if not fatal complication for you.
You should read the drug insert, which is usually available from the pharmacist, or go to the library and look up the drug in the PDR (the ten pound Physician Desk Reference which is more like a phone book of 6 point print that has the documented drug side effects and contraindications).
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