Category Archives: THINGS THAT DON’T FIT ABOVE

CAM Education, CAM Politics

Wyeth questions the role of pharmacists to compound HRT

 In April, Wyeth Labs renewed its request (submitted last October) for increased FDA regulation of compounding pharmacies that prepare hormone replacement therapy (HRT). Wyeth markets the HRT called Premarin and asserts that the HRT medicines prepared by compounding pharmacies can pose serious health risks.

Here is some historical perspective. Prior to the 1950s, when commercially prepared drugs became widely available, compounding prescriptions to be taken by mouth or inserted rectally was the main function of community pharmacists. In fact, as late as the 1970s (at least in New Jersey), compounding was part of the licensing exam for pharmacists.

In the 1970s, with the advent of total parenteral nutrition, preparation (compounding) of injectables increased by hospital pharmacists. In the 1980s there was a resurgence of compounding in community pharmacies.

In an excellent review, Dr. David Newton states, “Since the early 1990s, most national pharmacy practitioner organizations have asserted compounding is an intrinsic professional practice to be regulated by state boards of pharmacy.” The FDA usually defers to state boards to oversee this practice. Yet, state boards lack inspectors to enforce compounding practice standards, and most boards of pharmacy do not examine the compounding proficiency of their licensure candidates.

The implications of Wyeth’s anticompetitive petition according to the International Association of Compounding Pharmacists, is the “end to the option of prescribing bio-identical hormone replacement therapy for those patients that need it.”

The FDA is reviewing Wyeth’s request.

7/16/06 10:40 JR

CAM Politics, Marijuana (Cannabinoids)

Cannabis club banned at Fisherman’s Warf

This site reported previously about the growing resistance to medical cannabis clubs in San Francisco. Apparently, it is having an effect.

Now, The New York Times reports, “Marijuana cannot be sold alongside the cracked crab and souvenirs of Fisherman?s Wharf, the San Francisco Planning Commission decided late Thursday.” One commissioner stated, “the neighborhood was adamantly opposed to the dispensary?.

The cracked crabs will appeal.

7/14/06 09:30 JR

CAM Education

When is a side effect not a side effect?

Cultures around the world differ in what is considered a side effect (SE) that is important enough to report to a doctor during treatment or by a researcher during a clinical trial. Here are first-hand examples of what I mean. At the end I’ll explain why these differences are important.

SEs in Germany: The diabetes drug Precose (acarbose) was first tested in Germany, then marketed in Japan, and finally tested and marketed in the U.S. My first experience was in writing articles about Precose for Japanese doctors.

The German data indicated that flatulence was a known SE, but not a major problem. Yet, when it was finally studied and marketed in the U.S., flatulence was so severe that it prevented most people from taking Precose for any length of time.

Frustrated, the U.S. product manager eventually asked his German counterparts why their data never identified flatulence as a serious problem. They answered that in German trials, reported SEs came from patients who completed a study. Well, of course these were patients not bothered by flatulence, and thus the reported incidence was low. It ignored all patients in Germany who discontinued treatment because of SEs, such as flatulence.

SEs in the U.S.: U.S. studies report SEs on all patients who participate even for one dose. Therefore, there is likely to be a discrepancy between what is reported in a U.S. vs. German clinical trial. (My experience goes back more than 10 years, and it is possible that German clinical trial design has changed since then.)

SEs in Japan: My experience in obtaining SE data from Japanese studies is based on experience with photodynamic therapy. At the request of the U.S. Food and Drug Administration, a company sent me to Japan to collect safety data on this treatment. To my surprise, Japanese research reports listed almost no SEs. I later learned that Japanese patients were loath to report SEs to their doctors, because it was a sign of disrespect. Well, semasen goziemas, as Steve Martin used to say.

In a previous post I reported the position of the World Health Organization regarding the safety of herbals. I hope this explains why we should be dubious of this position.

7/14/06 14:18 JR

Acupuncture/ pressure, CAM Politics, Chinese Medicine, Meditation

Chinese medicine gaining credibility in the U.S.

The San Francisco Chronicle published an article last week on the integration of Chinese medicine (eg, acupuncture, tai chi chuan, meditation and others) into Western healthcare institutions. The American Hospital Association states that 20% of the nation’s hospitals offered complementary medical services in 2004 ? more than double the number in 1998. Continue reading Chinese medicine gaining credibility in the U.S. →

CAM Politics, Trans Fats

The coming change in trans fats

When Statistics Canada asked 35,000 people what they ate in the past 24 hours, pizza, donuts, subs and burgers were the staples of the great Canadian diet. I’m no better. I love french fries. My biggest complaint is that I can’t get enough ketchup on them.

The health risks associated with fries are worse here in New York, where McDonald’s ranks highest for trans fats. Fortunately, change is coming to the fast food industry; lead by Wendy’s, which recently committed to banning the use of trans fats in their cooking. (Check with you local outlet to see if they are complying.)

Other good news.

  • A Chicago aldermen wants the city become the first in the nation to ban restaurants from using trans fats
  • Panera Bread has reformulated recipes to make its menu nearly trans-fat free

The FDA says, “Scientific evidence shows that consumption of saturated fat, trans fat, and dietary cholesterol raises low-density lipoprotein (LDL), or “bad” cholesterol, levels, which increases the risk of coronary heart disease (CHD).”

This FDA website has a useful table comparing the fat content (including trans fats) of selected foods. There is also a pie chart on the main sources of trans fats in our diets.

Want to lean more? You can register at this Google link to get updates on trans fats.

7/8/06 11:22 JR

CAM Education, Meditation

Transcendental meditation in the classroom

David Lynch (The Elephant Man, Twin Peaks, and others) is funding the inclusion of TM in the classroom. The July/August 2006 issue of AARP The Magazine (Yes, I am a member.) reports his foundation has launched or is planning to launch meditation programs in six cities.

According to Mr. Lynch, “In the classroom where meditation is taught, you’d see students much happier, much brighter, eager to learn.”

It sounds like a good idea to me, but when you add new activities to a fixed time period, what is lost? Not reading, writing, and arithmetic, I hope.

7/1/06 10:00 JR

CAM Education, CAM Politics, Herbals

Treating herbal products as medicines in Spain

The latest issue of Functional Foods & Nutraceuticals e-newsletter is out. In it, we learn that Spanish authorities treat herbal products as medicines. They require such products to be withdrawn from the market and to obtain medicinal marketing authorizations.

In contrast to this, the European Commission considers that the absence of adequate procedures to assess the risk to public health that such products allegedly pose is an unjustified barrier to trade.

As a result of complaints from companies that want to market herbals in Spain, the European Commission is pursuing infringement procedures against Spain for hampering the free movement of goods in the market.

6/29/06 21:22 JR