September 12th, 2011 by David Kroll, Ph.D. in News, Research
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As early as 2006, I used to be able to write monthly about US FDA warnings on erectile dysfunction supplements being found adulterated with prescription drugs such as sildenafil, the phosphodiesterase-5 inhibitor found in Viagra. These adulteration episodes raised the question of how many anecdotal reports of herbal products “working” had to do with them containing approved medicines.
So common was this practice that FDA created a site in 2008 that was dedicated to this problem: Hidden Risks of Erectile Dysfunction “Treatments” Sold Online. Indeed, these products were more commonly encountered from online retailers and not in health food stores. Other similar practices include bodybuilding supplement being spiked with anabolic steroids and weight loss supplements being adulterated with sibutramine (formerly Meridia), an anorectant removed from the market last year after showing increased incidence of heart attacks and stroke in patients with preexisting cardiovascular disease.
The herbal industry, led by the American Herbal Products Association (AHPA), aimed to clean up this problem and launched an initiative called, KeepSupplementsClean.org. Spurred by an FDA letter to the industry on 15 December 2010 of increased scrutiny on the adulteration problem, AHPA actually encouraged FDA to Read more »
*This blog post was originally published at Science-Based Medicine*
August 13th, 2011 by David Kroll, Ph.D. in Health Policy, Opinion
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A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
July 17th, 2011 by David Kroll, Ph.D. in Opinion, Research
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So, you’re curious about herbal medicine. Is there any truth to this stuff?
Uncle Howie tells you that he read in the National Enquirer about an herb that has better antibacterial effects on cuts and scrapes than Neosporin ointment — never mind that Neosporin is composed of three different antibiotics that come originally from bacteria themselves.
So you set out on a quest to purchase some of this herb, known colloquially as goldenseal. When you go to your local Whole Hippie Dump-a-Load-of-Cash Emporium you find goldenseal alright, in about twenty different forms. On one side of the aisle are containers with loose, crushed up leaves and roots that look like medical marijuana. On a shelf, you find see-through capsules that seem to contain a powdered version of the herb. Down the aisle a bit you find boxes of blister-packs containing a proprietary extract of free-range goldenseal from the Appalachians harvested under moonlight by bare-breasted virgins. The same company also makes an ointment, allegedly procured the same way.
A scraggly young man with a rainbow-colored Whole Hippie tam comes by and says, “Dude, can I help you?” As you wave away the cloud of patchouli oil and three days of body odor, you ask him, “So, this goldenseal — which one should I buy?”
Hippie Boy looks both ways down the aisle and motions with his finger to come close.
“Dude, all this expensive stuff is just a ploy by The Man trying to make a buck with their fancy scientific words and processes. What you want is the whole herb, man — the stuff given to us by the sprites and spirits. Those capsules miss the point. Part of the magic is missing. You pay extra to get less.”
“But, dude,” you say. “I want to try the ointment, you know, for cuts and scrapes. How do I use this herb?”
The fine young man then explains how to make a poultice, an old-fashioned decoction of plant material that one wraps on a cut — sort of like collard greens.
This really seems like more trouble than it’s worth. You’re about a millisecond away from just heading down to the Done-Rite Drugs, Liquor, and Tobacco to buy a simple tube of Neosporin. But hey, it’s an experiment and you’re curious.
While you’re checking out from the health food store, a local scientist friend is in line at the next register, checking out your stash of goldenseal.
“You know, you should really go read Science-Based Medicine to get the straight dope on that stuff.”
And so, here you are. And I’m here for you.
[Note to readers: Apologies to my hippie friends. I love you all. No hippies were harmed in the drafting of this blogpost.]
Is there any scientific evidence to support a common herbalist claim that whole plant materials are “better” than semi-purified extracts or pure, individual chemicals made by the plant? Read more »
*This blog post was originally published at Science-Based Medicine*
May 20th, 2011 by David Kroll, Ph.D. in Health Tips, Research
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A very well-written review of an orally-active drug for multiple sclerosis has just appeared in the April 25th issue of the Journal of Natural Products, a joint publication of the American Chemical Society and the American Society of Pharmacognosy.
The review, Fingolimod (FTY720): A Recently Approved Multiple Sclerosis Drug Based on a Fungal Secondary Metabolite, is co-authored by Cherilyn R. Strader, Cedric J. Pearce, and Nicholas H. Oberlies. In the interest of full disclosure, the latter two gentlemen are research collaborators of mine from Mycosynthetix, Inc. (Hillsborough, NC) and the University of North Carolina at Greensboro. My esteemed colleague and senior author, Dr. Oberlies, modestly deflected my request to blog about the publication of this review.
So, I am instead writing this post to promote the excellent work of his student and first author, Cherilyn Strader. As of [Wednesday] morning, this review article is first on the list of most-read articles in the Journal. This status is noteworthy because the review has moved ahead of even the famed David Newman and Gordon Cragg review of natural product-sourced drugs of the last 25 years, the JNP equivalent of Pink Floyd’s The Dark Side of the Moon (the album known for its record 14-year stay on the Billboard music charts.). Read more »
*This blog post was originally published at Science-Based Medicine*
April 25th, 2011 by David Kroll, Ph.D. in News
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After spending the first 21 years of life in New Jersey and Philadelphia, I ventured to the University of Florida for graduate school. For those who don’t know, UF is in the north-central Florida city of Gainesville – culturally much more like idyllic south Georgia than flashy south Florida.
It was in Gainesville – “Hogtown” to some – that I first encountered the analgesic powder. I believe it was BC Powder, first manufactured just over 100 years ago within a stone’s throw of the Durham, NC, baseball park made famous by the movie, Bull Durham. I remember sitting with my grad school buddy from Kansas City watching this TV commercial with hardy men possessing strong Southern accents enthusiastically espousing the benefits of BC. I looked at Roger – a registered pharmacist – and asked, “what in the hell is an analgesic powder?”
What I learned is that powders of analgesic compounds were one of the individual trademark products of Southern pharmacies during the early 1900s. Many of these powders became quite popular with mill and textile workers needing to calm headaches induced by long hot days with loud machinery. The original powders contained a precursor to acetaminophen called phenacetin. However, phenacetin was found to cause renal papillary necrosis, such as in this 1964 case report in Annals of Internal Medicine.
Today, most of these powders are comprised of aspirin, acetaminophen, and caffeine. Read more »
*This blog post was originally published at Science-Based Medicine*
