1. Calls for Greater Data Sharing
The current issue of NEJM includes a series of perspectives articles advocating for greater data sharing among pharma companies, academic institutions and the government. One of the pieces is by Sen Elizabeth Warren, who supports, among other measures, a recent proposal by the International Committee of Medical Journal Editors requiring authors share de-identified data (so study participants aren’t identified) as a condition for manuscript publication. Other perspective articles are those from academic institutions and research consortiums. Increased data sharing has important implications for how pharma companies handle data in their research (e.g., a number already have publicly available data dossiers) – and present an opportunity for them to take a leadership position (and for us to help them with it!).
Somewhat related, the Wall Street Journal (7/18) ran a story on how pharma companies are looking for new ways to recruit patients for clinical trials. Among the approaches: evaluating test results to help identify qualifying patients, analyzing patient posts about their disease on online forums, and partnering with ride-sharing services to transport patients to clinical trial centers. Another way to help our clients!
2. New FDA User Fee Agreement Could Change Approval Process.
Congressional Quarterly (7/20) reported that “drug industry lobbyists and patient advocates are praising a preliminary” user-fee agreement between the FDA and companies that submit products for review. Under the agreement, the FDA would “consider how to incorporate patients’ perspectives into reviews,” issue guidance on “real-world evidence”, and “consider ways to promote new designs for clinical trials.” CQ noted that, “the deal could lead to shorter drug development timelines,” but “some consumer advocates worry that the approach could result in products that are less safe or effective.”
In a related article, Regulatory Focus (7/15) noted that the FDA published a 46-page document detailing the performance and goals for 2018 to 2022 as part of the sixth iteration of the Prescription Drug User Fee Act (PDUFA). The document presents the agency’s plan on user fees, lists deadlines for pilot projects and guidance documents, and notes important themes such as biomarker qualification, increased pharmacovigilance, patient input on the regulatory process, and the use of real-world evidence.
3. Immunotherapy: Bringing “New Optimism” To Oncologists. However…
In a nearly 5000-word front-page special report, the New York Times (7/30) described how immunotherapy, the process of “harnessing the immune system to fight cancer, [which had] long [been] a medical dream, is becoming a reality”. The NY Times stated that the “explosion of interest and billions of dollars of investments in the rapidly growing field” has “brought new optimism to cancer” physicians – “a sense that they have begun tapping into a force of nature, the medical equivalent of splitting the atom.” The Times cautioned, however, that “a troubling fact remains: Patients do not have equal access to the new treatments, which can be prohibitively expensive”.
However, on a related topic, an opinion piece in JAMA argues that, for years, medical research and funding has been dominated by the promise of genetics and information technology, with very little to show for it. The authors propose a wholesale reevaluation of the current approach, to define a better way forward in biomedical research.
4. Diabetes Drugs: About the Same in Reducing Risks For Heart Disease, Stroke, Or Premature Death.
A meta-analysis published in the July 19 issue of JAMA found “…no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. (The) findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with Type 2 diabetes and selection of additional therapies based on patient-specific considerations”Coverage in HealthDay, MedPage Today, and Medscape.
5. ACA, FYI
The current issue of JAMA has a number of editorials about the Affordable Care Act, how it could be improved, health care cost containment, and the future of health care in America. The issue also includes a “Special Communication” article by Barack Obama that reviews the evidence of the impact of the ACA on reducing the rate of uninsured, improving health care access and affordability, and improving health in various population segments.
In a similar vein, the July 21 issue of NEJM had a perspective piece on how many of the dire warnings of skyrocketing premiums under ADA are overblown.
6. Not For Geeks Only: Cool Stuff
The July 23rd issue of Science News has a great series of articles on aging. While scientists still don’t fully understand the process, it appears to be malleable, with a number of ways to slow it down and mitigate its effects. SN’s editor in chief notes that the issue is urgent, as the global population has never been older. By 2020, the number of people 65+ worldwide will outnumber children 5 and under for the first time in history. Take THAT, whipper-snappers!
The online edition of The Lancet has a very interesting and promising report on a Phase 1 trial showing human neural stem cell therapy improves neurologic function in patients who have suffered a stroke.