"The FDA Could be Hazardous to your Health" When I came across that headline in the online version of the National Review, I wondered what new health transgression the FDA had dreamed up. But after reading only a few dozen words of the article I realized that it was the article itself that could be harmful to those who might read it and buy into its misguided logic. The author of the article is Dr. Elizabeth Whelan - president of the American Council on Science and Health (ACSH) - and her premise, in a nutshell, is that the FDA recklessly allows food and supplement manufacturers to make health claims about their products, while pharmaceutical companies are "forbidden to publicly breathe a word" about some of the supposed "life saving benefits" of their best selling drugs. So if you actually believe that the well-meaning but powerless drug companies are being tragically restricted from saving lives, then get out your handkerchiefs. This one's a tear-jerker.
In her article, Dr. Whelan makes the dietary supplement industry sound like thieving pirates whose goal it is to take money from consumers and offer little in return. She argues that supplement manufacturers can make just about any claim they want, while "hiding behind the mantra 'These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.'"
Dr. Whelan's reaction to that familiar disclaimer is that it, "makes one wonder why anyone would take them." But what really upsets Dr. Whelan is the fact that drug companies are "forbidden" from telling the world that certain drugs that can save lives. She complains about FDA restrictions that make it illegal for drug company salespeople to inform doctors about medical articles supporting "off-label" drug use. But as she points out, a federal judge struck down those restrictions three years ago. So what's the problem? According to Dr. Whelan, there are still unanswered legal questions on this issue, and as a result, "most pharmaceutical companies are too intimidated to share published literature with physicians." Oh PLEASE! Even J.K. Rowling couldn't conceive of a fantasy world in which "most" pharmaceutical companies are intimidated by gray legal areas. The average reader probably accepts such a comment at face value. But doctors and drug salespeople must have doubled over with laughter when they read that one.
Dr. Whelan offers a short list of drugs that work cancer-curing miracles their makers are "forbidden to publicly breathe a word" about. To demonstrate just how unfair the situation is, she singles out an Eli Lilly & Co. drug called Evista.
Last January, in the e-Alert "Designing Women," I told you about Evista, which has become the standout brand among a class of drugs known as "designer estrogens" - also called SERMs (selective estrogen receptor modulators) - compounds based on synthetic variations of the estrogen molecule. Dr. Whelan says "the evidence is mounting that Evista reduces breast-cancer risk by as much as 84 percent." Based on this mounting evidence (not conclusive or overwhelming evidence) and one expert who states that Evista "clearly reduces the risk of breast cancer," Dr. Whelan complains about a "blackout" on this "exciting, potentially life-saving" information. In January's e-Alert, I told you about Elizabeth Barrett-Connor, M.D., who lead one of the early SERMs trials. Although Dr. Barrett-Connor is enthusiastic about Evista's prospects, she says that doctors should be careful to not yet recommend Evista for unproven indications. Her caution is reasonable and responsible, especially given that the drug's side effects include mood swings, hot flashes, and an increased risk of blood clots. Evista has also been shown to cause some postmenopausal women to begin menstruating again. Meanwhile, a major Evista study involving more than 10,000 women will be completed in 2006. This trial will reveal much more information about Evista's association with breast cancer risk, as well as the troubling side effects of the drug. But Dr. Whelan argues that we shouldn't wait for these trial results. Why? Because by all indications, she's convinced that Evista prevents breast cancer. Therefore, she reasons, Eli Lilly should go ahead and make that claim today.
One of the dietary supplements that Dr. Whelan dismissively mentions is saw palmetto. She says, "Saw Palmetto herbs boast they can 'support prostate health.'" I've never heard an herb boast, but I have read a number of studies demonstrating that saw palmetto is both safe and effective.
In 1998, for instance, the Journal of the American Medical Association reported on a review of 18 clinical trials in which saw palmetto was tested in the treatment of prostate enlargement - also called benign prostatic hyperplasia (BPH). The researchers concluded that saw palmetto significantly decreased BPH symptoms, resulting in increased urinary flow. Adverse effects were found to be "mild and infrequent." This is far from the final word on saw palmetto. Scientists still don't know exactly how saw palmetto manages to calm an enlarged prostate, so further research is necessary. And as with all dietary supplements, men with urinary problems or an enlarged prostate should carefully research the available studies and commentary, and then consult their doctors before trying any brand of saw palmetto.
If drug company executives and salespeople are too timid to stand up for themselves, Dr. Whelan is willing to rush in, guns blazing. But when the dust settles, she hasn't provided balanced or well-documented advice for those women who may read her article and be persuaded that the time for caution has passed, and safe breast cancer prevention can be found in a "designer estrogen."
And, at a time when we've seen the major Prempro study halted and Lotronex pulled off the market for contributing to several deaths, I'm not willing to jump the gun and rubber stamp off-label usage as the good doctor would suggest. Isn't the on-label usage of most drugs a big enough concern?
To Your Good Health, Jenny Thompson
Health Sciences Institute Sources:
"The FDA Could be Hazardous to Your Health" Dr. Elizabeth Whelan, National Review Online, 8/21/03, nationalreview.com
"Designer Estrogen May Be Better Than HRT" Salynn Boyles, WebMD Medical News, 12/18/02, webmd.com
"Designer Estrogens" Science News, v. 156, no. 16, 10/16/99, sciencenews.org
"Saw Palmetto Extracts for Treatment of Benign Prostatic Hyperplasia" Journal of the American Medical Association, Vol. 280, No. 18, 11/11/98, jama.ama-assn.org
"Effects of a Saw Palmetto Herbal Blend in Men with Symptomatic Benign Prostatic Hyperplasia" The Journal of Urology, 2000; 163: 1451-1456, jurology.com
| 
