Bioethics Commission Finds National Ebola Response Lacking

Earlier today the Presidential Commission for the Study of Bioethical Issues released a brief (90 pages, so your mileage may vary), Ethics and Ebola.  The report is intended to provide an assessment of the current Ebola outbreak (particularly of the response to cases diagnosed in the U.S.) and recommendations for becoming better prepared for future outbreaks.

The report’s recommendations cover how to prepare for outbreaks, ethical reasons for intervention in outbreaks, guiding principles for deciding to use restrictive public health measures (such as quarantines), and how to conduct research (if warranted) in outrbeak situations.  The recommendations are summarized below: Continue reading

Cancer Biopic Has Companion Radio Series

The film adaptation of The Emperor of All Maladies will premiere on PBS stations on March 30.  Running three nights, the film is produced by Ken Burns, directed by Barak Goodman, and is underwritten by more than a few companies and organizations that have major investments in cancer and/or cancer treatment.

While a three-night, six-hour miniseries is no small endeavor, a companion radio series, Cancer Stories, started on NPR stations Monday.  This is a ten-part program, airing on All Things Considered and Morning Edition all this week and the week of March 23 (the week prior to the premiere of Cancer: The Emperor of All Maladies.  Here’s a preview of the radio show (yes, it’s a video preview of a radio program).

And since you’ve probably missed at least one of the stories, they are available online following their initial broadcast.

Which Is The Bigger Problem – Vaccination Rates Or Disease Response?

Not long after the United States reacted…strongly…to a few cases of Ebola diagnosed within its borders, a measles outbreak has prompted another reaction.  Not the panic and problematic quarantines of last summer, but a debate over the ethics of mandatory vaccination.  That politicians weren’t necessarily backing the same kind of reaction depending on the outbreak added to the weirdness.

I wouldn’t fault you for a little cognitive dissonance.  If you’re not sure what I mean, take a look at this Tweet (H/T News.Mic)

(As far as I know, no countries have started screening arrivals from the United States for measles.)

Two diseases, both lethal, have prompted very different responses.  While there is a very reliable vaccine for only one of those diseases, there are likely other causes involved in determining why the two outbreaks (both ongoing, though the Ebola outbreak is no longer an issue in the U.S.) prompted different responses.  They include:

The source.  While measles has been effectively eliminated in the U.S. since 2000, it’s a much more familiar disease to Americans than Ebola. And while many of the post-2000 measles outbreaks in the U.S. have been sparked by people arriving from overseas, The more familiar something is, the less scary it will seem.  Scariness does not necessarily correlate with relative risk.

Continue reading

Appointment Heading For The Exits

While the confirmation challenges continue, at least one high-level science and technology appointee is stepping down.  Margaret Hamburg, Commissioner of the Food and Drug Administration, will step down at the end of next month (H/T ScienceInsider).  Even with slightly less than two years remaining in the Obama Administration, there is a chance Dr. Hamburg’s successor may not be confirmed before a new President is sworn in.  (I am encouraged by indications that a nominee has already been identified.)

Hamburg’s tenure is one of the longest in the agency’s history.  When she took over, the agency was struggling, with ethical challenges over drug approvals.  The agency is currently in the middle of regulatory changes for food safety oversight and medical device approvals, and it has not been perfect.  There were complaints over the agency’s inaction over compounding pharmacies (which are not presently regulated by the FDA), and Hamburg was overruled by Health and Human Services Secretary Sebelius over Plan B emergency contraception (though the courts eventually sided with the FDA).

Getting More Precise About The Precision Medicine Initiative

On Friday the White House formally launched the Precision Medicine Initiative.   I mused about it shortly after it was mentioned in the President’s State of the Union address.  While that post covered the why, the announcement on Friday also covered the how this Initiative might move forward.

While the National Institutes of Health (NIH) would receive the bulk of the $215 million (with much of its share going to the National Cancer Institute), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) would also contribute to the Precision Medicine Initiative.  The NIH and National Cancer Institute projects are focused on clinical research on individualized treatments and the FDA and ONC are focused on updating technical and regulatory infrastructure to better handle the kinds of data sets and data sharing expected to come from a project that burrows done to individual treatments.

A lot of this data will come from a voluntary research cohort, a group who agree to contribute their medical data (including genetics, lifestyle, metabolites, personal sensors and environmental information) to the effort and would help design the initiative.  This cohort would be one million strong.  Thankfully the Administration recognizes the privacy impact of making detailed medical information about that many people available for research access.  How effective they will be in assuring the privacy of this information remains to be seen.

While I recognize the impact of cancer, and how genetic markers for cancer can help in treatment, I’m a bit skeptical of how broadly focused a Precision Medicine Initiative can be when roughly one third of its budget targets cancer.  Yes, cancer takes many forms, and targeting individual treatments could benefit a lot of people suffering from rare forms of the disease – forms that don’t respond well to currently available treatments.  I’d rather this not become the Precision Cancer Initiative, at least not when it was first called something else.


So There Will Be A Lethal Injection Case After All

On Wednesday the Supreme Court agreed to delay the executions of three Oklahoma inmates (H/T SCOTUSBlog) who have a case before the Court concerning the method of those executions.  The order specified executions by midazolam, which is the drug at issue in Oklahoma.  While the case is scheduled for consideration by the Court in April, the three remaining condemned men were scheduled to die well before then.  Had the Court not acted when it did, there would now be two petitioners.

It is possible that Oklahoma could work around the order by setting up a new lethal execution protocol that does not use midazolam and have that protocol approved by the Court.  There has been even greater secrecy around lethal injection exections since drugs have become more scarce, and Oklahoma could be keeping things quiet if they were working on a new protocol.  Per SCOTUSBlog the state was seeking an order that explicitly permitted the delay to be conditional on using a different protocol.

It is worth noting that on Thursday the Supreme Court denied a request of a stay of execution from Texas.  Midazolam is not used in Texas, which currently opts for a massive does of pentobarbital to conduct its executions.  Should the Supreme Court decide against Oklahoma’s current execution drug protocol, I could easily see it simply eliminating midazolam or adjusting the dosage rather than barring the practice of lethal injection.

One Thread Of Post Myriad Activity Seems To Be Ending

Since the 2013 decision in the Myriad case, which invalidated some patent claims on isolated sequences of two genes relevant in some cases of breast cancer, there have been two major actions taking place.  Following the decision the Patent and Trademark Office (USPTO) has been working on guidance for potential patent applicants working with products of nature.  The latest guidance memo was released in December (H/T ScienceInsider), and the USPTO is taking comments until March 15.  There has been a back and forth with the biomedical research community, which has argued that the initial guidance (from March 2014) went further than the Supreme Court intended.  The USPTO has made changes in response.

The other post-Supreme Court thrust has involved lawsuits by Myriad Genetics against companies developing their own genetic tests for the breast cancer genes where Myriad held patent claims.  The company was protecting its market share and investment through the lawsuits and the settlement terms it has been able to reach..  ScienceInsider is reporting that many of the remaining cases have settled and The New York Times has noted that Myriad is working to address the remaining cases.