Pinterest recently stated that “..it would no longer return any search results, including pins and boards, for terms related to vaccinations, whether in favor or against them.” The firm noticed the majority of shared images on their site cautioned people against vaccinations. As I wrote in an article in 2017, “Anti-Science in the 21st century”. we have a safe, effective, affordable prevention of a terrible disease. Use it!
The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.
I am proud to be a member of the University of California, Davis, Library Leadership Board. The Library Leadership Board plays an essential role in sustaining and enhancing the excellence of the UC Davis Library by advancing the library’s philanthropic goals and priorities. It is the primary volunteer leadership group for the library, which is ranked among the top academic research libraries in North America.
This student video on the 10-year plan for UC Davis, To Boldly Go, has a great plea from a student about 32 seconds in. The student is having trouble finding a place to study in the Library for an upcoming mid-term examination. This is one of the issues we are trying to help – for many students, the Library is the only place they can study. We’re working on other issues as well, including scientific methods for dealing with Big Data in our digital scholarship program.
In a conference by a leading U.S. health insurer lobbying group (America’s Health Insurance Plans, AHIP), US FDA Commissioner Scott Gottlieb, M.D. criticized “Kabuki drug-pricing constructs” that profit industry at the expense of consumers. He stated “Patients shouldn’t face exorbitant out-of-pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries,” . “Sick people aren’t supposed to be subsidizing the healthy.” Much of the cash flow in patient payments for prescription pharmaceuticals is not disclosed to either patients or physicians, as described in my 2016 article, “What determines how much your patient pays for their medication in the United States” in the American Journal of Ophthalmology. Note that current U.S. law does not allow the FDA to consider drug pricing in their regulatory actions. However, FDA’s actions may affect pricing – e.g., speed of review and approval of generic marketing applications (Abbreviated New Drug Applications).
There’s a lot of talk and confusion of the issues involved in the role of compounding pharmacies for topical ocular medications (eyedrops). Please see this interview in EyeWorld in which I am interviewed about regulatory issues. I address the special role which compounding pharmacies have played in the therapeutic process as physicians tailor therapies to individual patients. At the same time, I discuss the issues in the use of compounding pharmacies for larger populations crossing state lines.
FDA continues to be open during government shut-down, due in part to user fees paid for by industry