On The Porousness Of Borders

(Apologies for the delay)

In the April 10 edition of Science, National Institutes of Health Director Dr. Francis Collins and Director of the National Institute of Allergies and Infectious Diseases Dr. Anthony Fauci wrote an editorial on where the research their Institutes support (and conduct) takes place.  The point of the editorial comes early:

“Now, in the face of serious fiscal constraints, the idea has reemerged from some congressional leaders and disease constituency groups to more closely align NIH funding for disease research with disease burden in the United States.”

Consider this the biomedical equivalent of Congressional efforts to ensure that National Science Foundation research is targeted to areas that advance the national interest.

Fauci and Collins write about why focusing research strictly on the United States is problematic.  It reminds us that one of the tools the United States uses in its foreign policy is public health.  And while they don’t mention it in the piece, disease does not respect national borders.  So while you could capture what diseases are affecting Americans at one point in time for the purposes of determining funding, that snapshot would soon be out of date.  And our public health infrastructure would suffer as a result.

NIH Seeks Public Input On Sustainable Biomedical Research

The National Institutes of Health (NIH) is seeking information from the public on topics intended to help boost the impact and sustainability of biomedical research (H/T FASEB).  Comments are due no later than May 17.

The NIH is seeking information on the following broad topics:

  • Input on key issues that currently limit the impact of NIH’s funding for biomedical research and challenge the sustainability of the scientific enterprise.
  • Ideas about adjusting current funding policies to ensure both continued impact and sustainability of the NIH research enterprise.
  • Ideas for new policies, strategies and other approaches that would increase the impact and sustainability of NIH-funded biomedical research.
  • Comments on any other issues that you feel are relevant.

This request will help inform the efforts of an NIH-wide working group headed by the director of the National Institute for General Medical Sciences, Dr. Jon Lorsch, on more efficient and/or sustainable funding strategies.  Past work in this area (from another working group) includes a possible ’emeritus award’ that would help senior researchers transition away from an NIH-dependent research position and assist the transfer of those research lines to younger researchers.  I mention that because I think the NIH would welcome creative approaches to these topics.

Again, comments are due May 17, and submission instructions are in the Request for Information.


Second Lawsuit Filed Over Guatemalan STD Experiments

Following the disclosure in 2010 that several Guatemalans were exposed to sexually transmitted diseases without their consent, several parties initiated a class action lawsuit against the government.  That lawsuit was eventually dismissed over the inability to sue the U.S. over actions conducted in another country.  For details on the experiments, consult the report from The Presidential Commission for the Study of Bioethical Issues.

The plaintiffs have not given up, yesterday they filed suit against Johns Hopkins University for its role in the exposures.  Several Johns Hopkins researchers held positions in panels that reviewed federal funding for the studies at issue in the suit.  Other defendants include the Rockefeller Foundation and Bristol-Meyers Squibb.

The suit is filed against these defendants apparently due to the affiliation several officials involved in the exposures had with the named institutions (or in the case of Bristol-Meyers Squibb, its predecessor companies).  Both Johns Hopkins and The Rockefeller Foundation have denied that their institutions were involved in the experiments.  Bristol-Meyers Squibb officials have declined to comment as of this writing.  The suit alleges that the experiments were used as clinical trials for the predecessor companies’ products.

With the dismissal of the previous lawsuit, it is not clear that the current matter will be any more successful.  Arguably the plaintiff’s case here will be harder, as holding an institutional affiliation will not likely be sufficient to demonstrate the institution was responsible for the conduct of particular individuals working for other organizations.

NIH Names Working Group For Precision Medical Initiative

To support the work of the Precision Medicine Initiative, the National Institutes of Health (NIH) announced the formation of a Working Group.  Part of the Advisory Committee to the Director, this Working Group will help develop the million-person cohort that is an important part of the Initiative.

The membership is two-fold.  There will be non-voting representatives from a variety of federal agencies and voting members with expertise in large clinical trials and/or precision medicine.

The working group will help determine how to design studies based on a cohort of such size, and the unique challenges such a group presents.  It will also coordinate efforts to gather public input from patient and stakeholder groups through workshops on various topics related to large-scale medical studies.  Opportunities for the public to comment should be publicized on the Precision Medicine Initiative website.

Raising Awareness Without Raising Unnecessary Procedures

Recently actress and director Angeline Jolie Pitt went public with he decision to have her ovaries and Fallopian tubes removed as a precaution against ovarian cancer.  This follows her double mastectomy in 2013 to address her risk of breast cancer.

Her willingness to discuss these decisions is admirable, and hopefully her example can prompt thinking and discussions around cancer and cancer risk with all of us.  But, as we keep learning over 43 years in to the ‘war’ on cancer, the disease, and the decision on how to address it, remain complex and challenging.  Jolie Pitt has been clear in noting all of the factors that led to her decisions and the careful thought and discussions she had prior to making those decisions.  However, press coverage has focused on the choices more than what informed them.  (In other words, if you are considering following Jolie Pitt’s lead, please read her pieces in full, and talk to your family and doctors, before proceeding.)

Before I discuss the risks and consequences of significant preventive procedures, two items worth noting.  Jolie Pitt is in a position to spend the time and money to obtain high-quality medical care many people might not have.  The genetic testing that informed her mastectomy decision is likely cheaper today (since Myriad Genetics patent-based competitive advantage has been weakened), it is still expensive, as are the numerous procedures involved in a double mastectomy and the removal of ovaries and Fallopian tubes.

For what it’s worth, I’m in the midst of a similar, but much less serious, medical situation.  I may not get to the point where something needs to be removed, but the possibility is no longer abstract for me.  I mention this now as it has come up since I last posted on the risks and consequences of preventive screenings.

It cannot be repeated enough – Jolie Pitt has a family history of both breast and ovarian cancer, and the latter was the cause of her mother’s death.  Right away cancer screenings would be recommended earlier and perhaps more frequently than for a woman of her age with no family history of cancer.  Her’s is a special case, and not representative of an ‘average’ breast or ovarian cancer patient. Continue reading

National Action Plan For Antibiotic-Resistant Bacteria Calls For More Judicious Use

Last fall the Obama Administration took several steps to combat the rise of antibiotic-resistant bacteria.  The steps included a report from the President’s Council of Advisers on Science and Technology, a National Strategy for combating antibiotic resistance, and the establishment of a government-wide Task Force to determine how to implement that strategy.

Earlier today the chairs of that task force, the Secretaries of Defense, Agriculture, and Health and Human Services, announced the release of the National Action Plan for Combating Antibiotic Resistant Bacteria. It is worth noting that the President has doubled the amount of money for fighting antibiotic resistance in his latest budget request.

The National Action Plan is focused on activities the country should take over the next five years to achieve the goals of the National Strategy.  The Task Force must provide the President with status updates on an annual basis, and the President’s Advisory Council on Antibiotic-Resistant Bacteria will advise the Health and Human Services (HHS) Department on the programs recommended by the National Action Plan.

Speaking of that Advisory Council, the HHS Department is seeking nominations. The Council will be a mix of public and governmental members (only the public members will vote) representing a variety of perspectives in the fields of public health, agriculture, and biomedicine.  Nominations will be accepted until April 29th, so submit them soon.

For me, the most interesting challenge in the National Action Plan is to reduce antibiotics use in the agriculture industry.  While consumer demand has driven some companies to reduce antibiotics in their food, antibiotics-free food is still a small portion of the total market.  The hardest challenge may well be establishing the kind of surveillance and reporting mechanisms to capture the best possible picture of current antibiotics uses.

If You’re Too Lazy To Drink Your Alcohol

Last year I posted about Palcohol, a powdered alcohol that was approved by the Alcohol and Tobacco Tax and Trade Board, but that approval was short-lived due to problems with the product labels.

Proper approval came through yesterday, making it legal to sell Palcohol in the United States.  The manufacturer has taken pains on the website to assure people that the product cannot be abused (not that people won’t try).  That the size and volume of the product necessary for spiking beverages, getting drunk and or smuggling it is too much to make it a practical method of abuse.

I am intrigued by the purported beneficial uses of the product that aren’t just making it lighter and easier to pack alcohol.  An ‘industrial formulation’ of the product could allow for easier forms of antiseptic, fuel, and other non-consumable applications for alcohol.

However, the industrial formula was not the one approved for sale.  The flavored versions of powdered alcohol have attracted the attention of several state legislatures, which are working on banning the sale of powdered alcohol.  Two states, Alaska and Delaware, already have laws on the books that cover powdered alcohol (for human consumption).

So, unless your state works to ban the product by the summer, you should be able to get your powdered drink on later this year.