At AMA’s meeting now underway, members will vote on a resolution to persuade FDA, FCC and FTC that retail prices of drugs must be included in all direct-to-consumer (DTC) ads. The proposal can be found here. Among the reasons for the recommendation, the proposal cites:
AMA has a history of opposing DTC ads for drugs, noting the only other country that allows it is New Zealand. Coincidentally, on June 14, the Senate Health, Education, Labor and Pensions (HELP) committee will hold a hearing on drug pricing that will include discussions with experts and will dissect how prices are determined.
Better payments for better outcomes?
In an interesting development related to pricing, UnitedHealth’s Optum unit signed a multiyear agreement with Merck to develop models for reimbursement based on patient outcomes. The initiative will use real-world data to co-develop and test predictive models and co-design agreements to reduce clinical and financial uncertainty about payments for prescription drugs.
Perceptions of pharma improved
The Reputation Institute found that people’s perceptions of the pharma industry improved by 3.5 points compared to last year, and is the best rating in 5 years. The rankings were based on opinions of 17,000 people in eight countries, including US residents, who gave the best reviews. The top 10: AbbVie (74.5), Novo Nordisk (74.0), Takeda Pharmaceutical (73.8), Roche (73.4), Janssen Pharmaceuticals (72.5), Gilead Sciences (72.4), Bayer (72.3), MSD (Merck, Sharp & Dohme) (72.2), Sanofi (72.0), and Eli Lilly (71.9).
Gotta have these meds!
WHO recently updated its “Essential Medicines List” (EML), adding 30 new ones for adults and 25 for children, bringing the total to 433. The EML includes major new advice on which antibiotics to use for common infections – the biggest change in the EML’s 40-year history. It also includes new medicines for HIV, hepatitis C, tuberculosis and leukemia. Many countries use the EML “to increase access to medicines and guide decisions about which products they ensure are available for their populations.” WHO updates the EML every 2 years.
Coffee may reduce liver cancer risk
Coffee, especially caffeinated, has been shown to have multiple benefits. Now, more good news for coffee drinkers: A systematic review and meta-analysis reported in BMJ Open showed both caffeinated and decaffeinated coffee are associated with a reduced risk of liver cancer, the sixth most common cancer worldwide and the second leading cause of cancer death. One cup a day was associated with a 20% reduced the risk for hepatocellular carcinoma (HCC) – which accounts for 85%-90% of liver cancer cases – and 5 cups/day was associated with a whopping 50% reduced risk. A particularly interesting finding: Evidence that the association was not significantly altered by stage of liver disease, high alcohol consumption, high body mass index, type 2 diabetes mellitus, smoking, or hepatitis B and C viruses.
Exercise in a pill?
A recent study reported in Cell Metabolism showed that a drug, GW501516, significantly increased exercise endurance in “couch potato” mice. In the study, sedentary mice not given the drug ran for about 160 minutes on an exercise wheel, but those given the drug for 8 weeks ran for 270 minutes. How does the drug work? Muscles use glucose as a primary fuel during exercise, but the sugar is also needed by the brain; when the body’s store of the sugar drops to a low level during prolonged exercise, the brain sends a signal to stop – “hitting the wall,” as many endurance athletes call it. Athletic training can make the body more effective at using fat for energy, sparing precious glucose. GW501516 appears to do the same thing. The next step with GW501516, which has been studied for more than a decade, will be clinical trials. Unfortunately, some unscrupulous marketers aren’t waiting for human evidence of efficacy and safety, and sell the drug (or what they claim is the drug) on the black market.
Share the data!
This could affect how clinical trials are run and published. The International Committee of Medical Journal Editors (ICMJE) is moving forward on its advocacy for broader clinical trial data sharing with study participants, because they have put themselves at risk. While recognizing the challenges to data sharing, ICMJE posted a commentary in many of its member medical journals (e.g., JAMA, NEJM and The Lancet) specifying requirements:
ICMJE said data sharing statements must indicate whether individual de-identified participant data will be shared; what data will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; and by what access criteria data will be shared, including with whom, for what types of analyses, and by what mechanism.