Homeopathy May Receive Heightened Scrutiny From Regulatory Agencies

While it appears (at least to me) to get more attention (and ridicule).  Homeopathy – the attempt to treat conditions with items that produce the same symptoms in healthy patients – is a business of note in the U.S.  While the Food and Drug Administration (FDA) regulates homeopathic treatments, it does not make claims as to their efficacy.

(Let’s put aside the discussion of what reason there might be to regulate a substance without judging whether it does what it is claimed to do.)

That might change soon.  According to Dan Vergano at Buzzfeed, both the FDA and the Federal Trade Commission (FTC) may act soon on homeopathic treatments.  The FTC has raised concerns that FDA practice in this area runs counter to the FTC requirement that health claims in advertising need to be backed up by “competent and reliable scientific evidence.”

This has, apparently, been a longstanding conflict, as the FDA first promised to put homeopathic products up to a standard comparable to the FTC’s in 1972.  Maybe, just maybe, this long standoff is approaching an end.

Precision Medicine Initiative Working On Its Privacy

On Monday the Obama Administration released Privacy and Trust Principles for the Precision Medicine Initiative.  This follows a public comment period responding to the draft principles released this summer.

My comparison of the draft and final principles suggest that most of the changes are in terms of streamlining and reorganizing the document.  The concerns I had at the time I posted about the draft principles remain.  An enforcement regime for these principles is not within the document, and I think it is critical to success in obtaining the data from the million individuals the Initiative wants.  The same is true of the Security Policy Framework (what was probably the Security Framework in the draft principles).

The broad Privacy and Trust Principles described by the document are:

  • Creating a dynamic and inclusive governance structure
  • Building trust and accountability through transparency
  • Respecting participant preferences
  • Empower Participants through Access to Information
  • Responsible data sharing, access and use
  • Maintaining data quality and integrity

Ebola Outbreak Continues, With Some Good News

Since the little panic has subsided in the U.S., little attention has been paid here to the Ebola outbreak in West Africa.  While it has not yet ended, there is some good news.

While the epidemic re-emerged in Liberia earlier this year, as of November 7 it has retreated from Sierra Leone.  This means that it has been seven weeks since the person with the last reported case of the disease has had a second negative blood test for the virus.  For the next 90 days World Health Organization and other personnel will engage in a period of enhanced surveillance to ensure no new cases of Ebola emerge in the country.

As of November 1 there have been 28,571 reported confirmed, probable and suspected cases of Ebola since this outbreak officially began in Mary 2014.  There have been 11,299 reported deaths linked to these cases (though it is not always clear that Ebola was the proximate cause of death).

While the outbreak is subsiding, the lasting damage to the physical and social systems of the affected countries will linger for a long time.  (For instance, since this outbreak affected those over 14 much, much more than those under 14, there are a lot more orphans in the affected countries.)  Recovery efforts will continue for months, and the damage caused will linger for longer.

PCAST Wants People To Hear Better For Less

On Monday the President’s Council of Advisors on Science and Technology (PCAST) released a letter report on innovation in hearing technologies.  The focus of the report is on the technologies used for mild and/or moderate hearing impairment.  The aging population will have need of such technologies, but a relatively small percentage of people who could benefit from them actually use them.  To help support the report recommendations, PCAST makes the argument that the current market and regulations covering hearing aids lead to a relatively static market that provides little innovation and extracts rather large costs for devices, preventing many from purchasing them.

The recommendations are exclusively about regulations.  PCAST recommends that non-surgical air conductive hearing aids be allowed for over-the-counter sales without needing to visit a credentialed dispenser.  Similarly, the report recommends that diagnostic tests for fitting and adjusting these devices should be available over the counter.  PCAST wants the Food and Drug Administration to withdraw its 2013 draft guidance on personal sound amplification devices (PSAP), which, in the opinion of PCAST, heightens an artificial distinction between the two kinds of devices that prevents those with hearing loss to benefit from advances in technology.

(While the report does not address this head on, the distinction between hearing aids and PSAP devices touches on the different values placed on technology that restores ‘normal’ function and technology that ‘augments’ that function.  Possibly a topic more appropriate for the Bioethics Commission.)

The other two recommendations call for consumers to have the ability to take the results of relevant hearing and audio tests acquired from hearing aid dispensers and audiologists at no additional cost.  This would be comparable to what consumers can already do with vision tests for eyeglasses and/or contact lenses.

The date of the next PCAST meeting is November 20, though it is not currently on the PCAST website.  This letter report will be on the agenda, along with presentations on nanotechnology and new regulatory frameworks for research.   The PCAST study on private sector activities in climate change adaptation and resilience.  More details will be available once the draft agenda is online.

Department Of Veterans Affairs Seeks Input On Open Access Plan

Last week the Department of Veterans Affairs (VA) released a Federal Register notice seeking comments on its open access data policy.  (As of this writing the most recent version is dated July 23, 2015.)  Comments are due by November 6.

The policy is in response to the Administration’s initiative to establish open access policies for research results and research data generated through federal funding.  Research funded by the VA involves a lot of confidential patient information, and the access policy devotes many pages to detailing how best to ensure access to research results that also preserves – as much as possible – the privacy of patients in clinical trials and related research.  This means that the agency (much like many others required to comply with this policy) will be doing a lot of work over the next few years to implement new data storage and access systems.

To that end, while the agency will allow for public access to research results starting no later than December 31, 2015, such access will not be unrestricted until at least December 31, 2016.  Even

As might be expected from a (comparatively) smaller research agency, the VA will take advantage of existing repositories for their research results.  They are working with the National Institutes of Health to have VA funded research results deposited in PubMed Central.  Articles will have to be deposited in that repository within 12 months of publication.  Clinical trial results will have to be deposited in the database at clinicaltrials.gov.

Each researcher applying for VA funds will have to submit a data management plan that includes how the research data will be preserved and made available for public access.

There are no questions attached with the request for comment, but interested parties with their own questions and/or suggestions for how to refine the plan, increase the ease of implementation, and other ideas, should go ahead and submit them by November 6.

We The People – A Meaningful Tool For Disease Advocacy?

A fair number of petitions on the We The People site focus on individual matters.  This could be a petition about a bestowing an honor on a particular person, seeking some kind of criminal proceeding (or the ending of same), or resolving some injustice.  Individual matters can also include specific species or diseases.

A petition on sickle cell disease (one type of which is sickle cell anemia) was started last September and gathered enough signatures to receive a response from the Administration.  While the petition mentions support for a particular piece of legislation (which did not advance in the last Congress) the Administration’s response focused, as is its custom, on executive branch actions.

The response describes how the Department of Health and Human Services and the Centers for Disease Control are doing to improve understanding and awareness of Sickle Cell Disease.

Now, from an uninformed outsider, this seems to be a case where the Administration response implies a message of ‘don’t worry about it, we’re giving it the level of attention that (the petitioners) want.’  Presumably the disease organizations that spearheaded the petition drive have been doing other things to make sure Sickle Cell Disease gets the attention they think a national health priority warrants.  But I wouldn’t blame anyone who considers the response little more than lip service.

Petition Site Dabbles In Science And Technology Topics

In late July the White House announced a revision of its We The People petition site, and released several petition responses at the same time.  Some of those petitions addressed science and technology topics.  I’m very late in getting back to this, but it’s worth exploring each of those responses, if only briefly.

In February of this year, a petition was filed to ban the mandatory vaccination of anyone for any reason.  Not that the Administration seriously considered agreeing with the petitioner, the response was very thorough and accompanied by a video message from the Surgeon General of the United States, Dr. Vivek Murthy.  In the response both Murthy and President Obama are quoted on the necessity of vaccination and the benefits of the same.  The response notes that state and local laws typically determine vaccination policies for school admission, and that typically employers are the parties responsible for any vaccination policies for their employees.