Emptying the Notebook: Revisiting Dr. Oz, More Qnexa Comments

My interview last month with FDA's Dr. Daniel Fabricant, Ph.D., regarding spiked supplements came a few weeks after that whole Dr. Oz controversy,  when the talk show host focused on spiked supplements.

I should have tied the two pieces together. For some reason I didn't, even though I talked to Judy Blatman, senior vice president, communications, for the Council for Responsible Nutrition, in late January to get her reaction about any potential Dr. Oz fallout.

What's funny is some of Blatman's key points about the episode could double as a response to Fabricant's comments, which came about two weeks later. 

1.) "The problem itself of spiking products with illegal drugs is one of the most serious problems that our industry faces from a reputation standpoint and from a safety standpoint," Blatman told me. "And the fact that Dr. Oz, who is such a strong supporter of dietary supplements, felt that he had [to devote a show] reinforces its importance.

Even though majority of companies, she added, are following GMPs, the subject of spiked supplements was "fair game" for the good doctor to cover. 

2.) Blatman said that it's to the industry's benefit to find out how to stop the spiking of supplements. Specifically, companies need to help consumers differentiate between those with legitimate intentions and those looking to make a quick buck. CRN does have tips for consumers available on its Website.

3.) If FDA has an issue with spiked supplements, it needs to take "stronger action," a move that would be welcome, Blatman said. (CRN is one of many members of Alliance for a Stronger FDA.) Fabricant, if you recall, said the industry had to show more effort. 

It's going to be really interesting to see how FDA and the industry proceed, especially if news outlets keep going down the same road as Dr. Oz.

*In the midst of ranting and raving about Qnexa, I neglected to include some comments from SSC contributors. Consider it additional food for thought.

Here's Dr. Holly Lucille, N.D., on the matter: 

"There has never been a drug for 'obesity' that has ever proven to be successful without detrimental side effects. This one will prove to be the same. Obesity in the majority of cases is a product of lifestyle choices and if we are to 'treat' it appropriately we need to understand the multitude of influences on an individual's case and drill down and unravel the consequences from those choices. This way people actually have the chance to heal and grow. Identify and treat the cause and treating the whole person is the lynchpin of true healing."

James Gormley, as his wont, didn't mince words:

“The FDA has no legitimate choice but to disapprove the outrageously misguided combination of a stimulant whose deadly history in the Fen-Phen disaster is now a dark cautionary of legendary dimensions and a brain-numbing anti-convulsant, for the love of God!

Apparently, there’s no end in sight for the widespread run-arounds that circumvent the whole purpose of FDA drug approvals---if physicians and potentially the FDA are making a mockery of the FDA approval process, why bother having labels!?

What’s next!? Since we already have anti-contraceptive combinations (such as drospirenone plus ethinyl estradiol) being used off-label for cosmetic skin complaints like acne, maybe we can use powerful cancer drugs for heat rash?

While gray-market operators on the fringe of the dietary supplement industry have not been blameless in trying to feed consumers’ desire for a magic pill approach to weight loss (remember ECA stack combos?), Big Pharma has been hungrily gnawing at the gates of the obesity market for decades.

Unfortunately what gave a stamp of pseudo-validation to pill-popping weight loss was the ill-begotten December 5^th, 1994 release of a report from the Institute of Medicine, which declared that obesity should be treated as physicians treat other genetic and biological diseases -- with extended drug therapy or surgery.

With the FDA’s abysmal track record and history of collusion with Big Pharma and corruption, the FDA has an extremely important choice here: (1) approve this outrageous combination, thereby cementing the argument that the FDA should be dissolved and replaced with something that actually is worthy of our respect: or (2) disapprove this combination in order to deliver two messages: (a) the FDA does sometimes protect consumers and is trying to do so here and (b) drug manufacturers should stop trying to circumvent and render irrelevant the drug approval and labeling process by trying to legitimize crazy off-label combinations and uses that should be banned.”