By Len Monheit
It’s now 2006, with a whole new world of opportunities open and beckoning before us.
The ongoing healthcare crisis continues to fuel interest in the industry, and nutritional awareness continues to be a dominant behavior. Obesity is a defined ‘public enemy’; Adverse events for drugs continue to gain media attention.
This all bodes well for sector growth and prospects, but a crowded marketplace, lack of substantiation, bogus claims, product quality issues, and some of the perceptions others have of us continue to impede realization of potential. It’s all really quite frustrating – we’ve got some great products, some good science, an excellent value proposition, leading companies, strong and charismatic individuals and visionaries – yet we continue to fight many of the battles, both internally and externally as was the case several years ago.
The relatively quiet holiday period saw the New York Daily News, in an article called, “Beating the Heat” (http://www.nydailynews.com/front/story/377636p-320846c.html) attack dietary supplements, the industry in general, as well as legislation, citing such ‘experts’ as:
UCLA professor Don Catlin, who runs the Olympic drug testing lab in Los Angeles: "It was very clear to me that DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids and all kinds of things, which I thought was wrong,"
U.S. Rep. Henry Waxman (D-Calif.) "DSHEA made the marketplace of dietary supplements essentially ungovernable… There are certainly illegal steroids masquerading as supplement products out there, but because of DSHEA, the FDA has no tools to keep these products from being marketed in the first place, and limited tools to police them once they are on the market,"
Bill Gurley, a professor of pharmacological sciences at the University of Arkansas for Medical Sciences: “Most people were using ephedrine to make methamphetamine…"I would guess that (ephedra) had a greater impact on meth than we realized. I've had several law enforcement people here in Arkansas say they found large amounts of ephedra in labs they busted.”
So ephedra is still great news, and industry bad-actors still get a lot of attention. And science keeps on delivering mixed results, with negative results overshadowing coverage of positive reports.
The very same day that research in the Journal of the American Medical Association (http://jama.ama-assn.org/cgi/content/short/294/24/3101) indicated that in the elderly, vitamin C, vitamin E beta-carotene and zinc in the diet correlated to lower risk of macular degeneration, the American Journal of Gastroenterology (http://www.amjgastro.com/showContent.asp?DID=4&SessionGUID=566748AD-C0FF-413C-B98A-4F4B166A64B6&id=ajg_262112005&type=abstract) noted that after examining clinical trials involving the use of milk thistle for liver disease, no change in risk of adverse events was observed. That was last week.
This week, JAMA (http://jama.ama-assn.org/cgi/content/short/295/1/58) reported on the use of L-arginine therapy in incidences of acute myocardial infarction, noting that the researchers observed that six patients taking the arginine supplementation died during the initial six months of the study versus none in the group not receiving arginine, with quite predictable and sensational headlines emerging. Bill Sardi has written a commentary and perspective on this study. (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=14528&zoneid=28) And finally, the Journal of Clinical Investigation published a mouse study which indicated that transgenic mice with a mutation for heart disease (hypertrophic cardiomyopathy), when fed a soy diet were severely affected and showed enlarged heart muscles and heart failure (presumably part of the signs of the disease one would expect although in increasing severity). Conversely, mice fed a casein-based diet no longer exhibited the deterioration to severe cardiomyopathy. Female mice were unaffected either way. A commentary on the article attempts to put the study in perspective by claiming that it shows that in this case, diet has a significant modifier effect on disease progression, but that’s certainly not the perspective or context which appeared in the media pick up of the study.
As we review these developments, it’s obvious that this is not the most auspicious of start to the year. Industry will soon however have the opportunity to be extremely proactive on the subject of both AERs and GMPs, and we can expect both supporters and adversaries to be equally vocal.
To close for today, each ‘pot shot’ (some noted above) hurts us collectively. Each ‘pot shot’ left unchallenged takes on the perception of truth.
Kudos to those that are actively challenging or at least trying to put in perspective the ‘shots’ we face.