July 5th, 2011 by David H. Gorski, M.D., Ph.D. in Health Policy, Opinion, Quackery Exposed
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The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.
Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, 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*
May 14th, 2011 by StevenWilkinsMPH in Health Tips, Opinion
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Lots of smart people over the years have been trying to figure out why people stop taking their medications within the first 12 months. Within the first 12-months of starting a new prescription, patient compliance rates drop to less than 50%. This rate is even lower for people with multiple chronic conditions taking one or more prescription medications.
If these medications are so important to patients, why do they just stop taking them? It defies common sense. Sure issues like medication cost, forgetfulness, lack of symptoms, and psychosocial issues like depression play a role in patient non-compliance. But there also something else going on…or in this case not going on.
The problem is that doctors and patients simply don’t talk much about new medications once prescribed. Here’s what I mean. Let’s say that at a routine check-up a physician tells a patient that he/she wants to put them on a medication to help them control their cholesterol. The doctor spends about 50 seconds telling the patient about the medication. The patient nods their head takes the prescription and boom…the visit is over. Read more »
*This blog post was originally published at Mind The Gap*
May 9th, 2011 by Toni Brayer, M.D. in News
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The top 10 prescribed drugs in the U.S. for 2010 in order of prescriptions written are:
- Hydrocodone (combined with acetaminophen) — 131.2 million prescriptions
- Generic Zocor (simvastatin), a cholesterol-lowering statin drug — 94.1 million prescriptions
- Lisinopril (brand names include Prinivil and Zestril), a blood pressure drug — 87.4 million prescriptions
- Generic Synthroid (levothyroxine sodium), synthetic thyroid hormone — 70.5 million prescriptions
- Generic Norvasc (amlodipine besylate), an angina/blood pressure drug — 57.2 million prescriptions
- Generic Prilosec (omeprazole), an antacid drug — 53.4 million prescriptions (does not include over-the-counter sales)
- Azithromycin (brand names include Z-Pak and Zithromax), an antibiotic — 52.6 million prescriptions
- Amoxicillin (various brand names), an antibiotic — 52.3 million prescriptions
- Generic Glucophage (metformin), a diabetes drug — 48.3 million prescriptions
- Hydrochlorothiazide (various brand names), a water pill used to lower blood pressure — 47.8 million prescriptions.
Notice that most of these are generic so they aren’t the ones that make the most money for Big Pharma. Those drugs are not offered in generic and they brought in n $307 billion in 2010. What was number one? Drumroll……..
Lipitor, a cholesterol lowering statin.
In case you wondered who is paying for these drugs…Commercial insurance helped pay for 63% of all prescriptions. Medicare Part D (Federal government) paid for 22% of prescriptions. The average co-payment for a prescription was $10.73. The average co-payment for a branded drug was $22.73.
If you are paying for prescriptions, make sure you ask your physician if it is available in generic. It can save you a lot of $$.
*This blog post was originally published at EverythingHealth*
April 28th, 2011 by AndrewSchorr in Health Policy, Opinion
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Imagine you’re a pharmaceutical company product manager and your specific product helps people with a chronic illness, or a cancer that can be managed by taking a pill or an injectable medicine over many years. You want to be part of the dialogue patients have with each other. You want to be part of the community. Facebook users, and other social media participants, are increasingly forming groups around health conditions, big and small. You want to be there, because, after all, your company has invested hundreds of millions of dollars developing the approved drug and hopes this medicine, and perhaps a successor, will be on the market for a long time.
This is an exciting time on the Internet and pharmaceutical product managers want to be part of health discussions. But it is fraught with legal pitfalls and penalties that can range into the millions of dollars if the product manager, or associated marketing agencies, make even an innocent mistake. Read more »
*This blog post was originally published at Andrew's Blog*
