Private Parts
Here’s how you know when a drug’s side effects are completely out of control: When the federal government requires you to place your name and personal details about your sex life in a national registry in order to purchase the drug.
Sound extreme? It is. But this is the plan that an FDA advisory panel has come up with in an effort to reduce birth defects caused by Accutane, the prescription medicine designed to treat severe acne. As for other Accutane side effects (mostly associated with emotional instability), well, with those you’re on your own.
But for anyone, young or old, who copes with the discomfort and embarrassment of serious acne, the need for a drug and all its side effects might be made completely unnecessary with a simple change in diet.
Someone to watch over you
In the e-Alert “Dying of Embarrassment” (1/15/02), I first told you about the problems associated with Accutane use. Here are some of the highlights or rather lowlights:
- According to the FDA, between 1998 and 2000 Accutane was linked with at least 160 cases of suicide, attempted suicide, suicidal thoughts, and hospitalization – more than 50 cases a year.
- Other side effects (listed on the web site of Roche, Accutane’s manufacturer) include depression, psychosis, acute pancreatitis, inflammatory bowel disease and vision and hearing impairment.
- In 1990, the FDA estimated that since the drug’s introduction in 1982, there had been 11,000 to 13,000 Accutane-related abortions, and 900 to 1,100 Accutane- related birth defects.
All of these side effects are troubling, and the suicides are particularly alarming. But last week’s recommendations from the FDA advisory panel specifically address the tragic tendency of Accutane to cause severe birth defects when used by pregnant women.
In 2001, Roche began a program to help prevent birth defects associated with the drug. Under this program, all females who take Accutane are encouraged to use two forms of birth control and take regular pregnancy tests. Even though these guidelines make it very clear that Accutane users who become pregnant are putting their unborn children in grave danger, the rate of birth defects stayed about the same. In response, the FDA panel recommended that the guidelines become mandatory, and that a registry be established to list every Accutane user (male or female), along with a record of pregnancy tests and birth control use.
If the FDA decides to accept the panel’s recommendations, Big Brother will be looking over the shoulders – and in the bedrooms – of all Accutane users.
Three strikes
To say the least, the FDA is a very aggressive regulatory agency. But this plan for a registry that will record details about a patient’s sexual life is an extreme invasion of privacy, even by FDA standards. Furthermore, it’s not even necessary because it simply won’t work. Here are three | reasons why:
1) The program to prevent pregnancy among Accutane users is already in place. If users don’t follow the current program, they’re not likely to follow it when it’s mandatory, unless each female user is escorted everywhere she goes by an FDA Accutane policeman.
2) The regulations can’t possibly be monitored and enforced. During a time of budget cutbacks throughout government agencies, is the FDA really going to mount an Accutane Task Force to make sure all the pregnancy tests have been submitted and everyone is taking their birth control? And if not, what’s the alternative? Will they start arresting Accutane users when they become pregnant?
3) If you go to the Internet and search “Accutane” and “without a prescription,” you’ll get scores of responses – site after site after site – offering Accutane with no questions asked. Needless to say, these sites don’t require pregnancy tests or any assurances about birth control.
Potato pushaway
According to a dermatologist who’s also a member of the FDA advisory panel, one of the problems with Accutane is that it’s over-prescribed. The drug is intended to address only very severe cases of acne that create large cysts. Inevitably, however, many doctors prescribe the drug for relatively normal acne cases.
This is a shame, because for people who don’t have extremely aggressive acne, a change in diet will often help clear things up.
In a 2002 article published in the Archives of Dermatology, researchers at Colorado State University wrote that acne is a problem for as much as 95% of adolescents, and half of the men and women over age 25 in westernized societies, while the rates are much lower in non-westernized countries. In fact, they call the difference in the rates “astonishing.”
For many years, alternate medicine practitioners and nutritionists like Jonathan V. Wright, M.D., and Adelle Davis have known that wheat intake can prompt acne outbreaks. And recent studies confirm that acne thrives when the diet is rich in high glycemic foods. Here’s the suspected chain of events: Bread, cereal or potatoes are consumed, digestion increases glucose levels, insulin production rises and triggers hormones to secrete sebum in pores of the skin, and the sebum attracts acne-promoting bacteria.
According to many dermatologists, a wide body of anecdotal evidence supports the theory that a low-carbohydrate diet may be the best first defense against acne for patients of all ages. If you know a young friend or family member who suffers from this painful and often embarrassing problem, | let them know that there may be a safe dietary alternative to powerful drugs with dreadful side effects.
Same old same old
Once again I can’t help but note that if an herbal supplement were associated with the level of problems that Accutane is, we would hear nothing but long howls of indignation that such a product is available to minors, let alone frequently prescribed to them. And it would be followed by a mob of congressmen demanding its immediate removal from the market, which would probably still be preferable to them monitoring the activity in your bedroom.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
“Panel Urges Stricter Limits on Acne Drug” Lisa Richwine, Reuters Health, reutershealth.com, 3/1/04
“Panel Backs National Accutane Registry” Lauran Neergaard, Associated Press, 2/27/04, aberdeennews.com
“FDA Announces Changes to the Risk Management Program to Prevent Birth Defects Caused by Accutane” FDA Talk Paper, 10/31/01, fda.gov
“Bread May Be the Culprit Behind Acne” Dr. Joseph Mercola, 12/25/02, mercola.com
“Acne Vulgaris: A Disease of Western Civilization” Archives of Dermatology, Vol. 138, No. 12, December 2002, archderm.ama-assn.org
