Here’s this week’s (slightly abridged) edition. Enjoy!
Petrie-Flom Interns’ Weekly Round-up: October 6 – October 12
By Kathy Wang and Hyeongsu Park
- Despite protests, Rhode Island instituted a mandate for flu shots for all healthcare workers. This includes doctors, nurses, other employees, and volunteers at hospitals, nursing homes, and health-related organizations.
- Earlier this week, the FDA announced it would be taking action against thousands of illegal Internet pharmacies. This initiative is targeted towards protecting consumers from potentially unapproved, dangerous drugs or medical products.
- British pharmaceutical company GlaxoSmithKline released its findings on data for drug trials while also pledging to devote more resources towards the discovery of new medicines. This move towards transparency and collaboration is thought to be a response to critics suspicious of secretive pharmaceutical practices.
- In the midst of a recent meningitis outbreak spread from the use of medical steroids that have left over 130 sickened, lawmakers have calling for increased regulation of the pharmacy industry. Despite this, pharmacies have resisted and argued that regulation will only worsen the industry.
- After a US government advisory panel in January suggested that research using deliberately modified strands of the bird flu could possibly endanger the public, most research was halted. However, 9 months after this moratorium, the debate continues.
- On Thursday, the Journal of the American Medical Association published on online guide to the major health care and health policy issues that are shaping discourse in the 2012 election. Included are diagrams and tables representing voter demographics, political views, and economic implications of the different policies.
- When two stem-cell scientists were announced to share the 2012 Nobel Prize for Medicine this week, some began to question the ethical implications of this award. A Bioedge article probes some of these concerns and finds the scientists should be also honored with a “Nobel Prize for Ethics” for their upstanding handling of contentious bioethical issues.
**And a few more from the editors:
Attention Disorder or Not, Pills to Help in School
This Election, a Stark Choice in Health Care
Pepsi and Coke to Post Calories of Drinks Sold in Vending Machines
Before a Wave of Meningitis, Shots Were Tied to Risks
Oakland Sues U.S. to Prevent Closing of Marijuana Dispensary
Suit Is Filed Over Move to Regulate Circumcision
Redefining Medicine With Apps and iPads
The Ups and Downs of Electronic Medical Records
JAMA Forum: Reproductive Freedom and the 2012 Presidential Election
Glenn Cohen and his co-author, Eli Adashi, have a new blog post out at the JAMA Forum on reproductive freedom and the presidential election:
It is commonly assumed that the economy will constitute the key, if not sole, battleground of the 2012 presidential election. That may well be the case. In the past several months, however, both parties have paid ever-growing attention to the possibility that the candidates’ positions on issues involving reproductive freedom could affect the leanings of women voters and thereby the final outcome. In conducting intense monitoring—not to mention targeted messaging—in this area, both presidential campaigns have acknowledged that for many women, especially women of reproductive age, reproductive health is as much an economic issue as it is a health care issue.
In a departure from past campaigns, the 2012 presidential election ventures beyond the confines of the abortion issue to incorporate a tapestry of competing ideologies on related questions. Given the interest in these issues, the positions articulated by President Obama and Governor Romney in the domain of reproductive freedom may well be a factor in the 2012 election, because an analysis reveals 2 very different points of view.
Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option
A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.
The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.
Upcoming Event: Human Rights and the Social Determinants of Health, November 1-2, 2012 at Northeastern University
Human Rights and the Social Determinants of Health
Thursday, November 1, 2012, 1-5:30pm
Friday, November 2, 2012, 12-1:30pm
Northeastern University School of Law
Dockster Hall
65 Forsyth Street, Boston
The Program on Human Rights and the Global Economy (PHRGE) and the Program on Health Policy and Law at Northeastern University School of Law are hosting an event entitled “Human Rights and the Social Determinants of Health” on November 1 and November 2, 2012. The keynote speaker will be Dr. Ichiro Kawachi, from the Harvard School of Public Health. The event will also feature a special presentation by Sir Michael Marmot of University College London. Marmot is known internationally as a pioneer in the field of the social determinants of health. For further information, please contact Sasha Varasano
Call for Papers – Petrie-Flom Center Annual Conference: The Food and Drug Administration in the 21st Century
We are pleased to announce plans for our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.” This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. For details on the event and the call for proposals, see the Call for Papers/Presentations. Abstracts are due no later than December 10, 2012.
Petrie-Flom Academic Fellowships – Apps Due Nov. 16
Just a reminder to spread the word about the Petrie-Flom Academic Fellowship Program. We are currently accepting applications for the 2013-2015 fellowship cohort. Applications are due Nov. 16, 2012. The full call with all the details can be found here.
Reminder, TODAY – Patients with Passports: Medical Tourism, Law, and Ethics
TODAY!
4:00pm
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA
Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.
Petrie-Flom Faculty co-Director I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.
FDA Drug Amendments: Still a good fit at fifty?
Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the amendments instituted the four-phase review process and the requirement that manufacturers get informed consent from people receiving experimental drugs. If the past fifty years is any indication, though, its unlikely that FDA’s current regulations are well suited to deal with the changing context of medicine, including clinical trials of stem-cell therapies forecasted with the Nobel Prize Committee’s awarding of their prize in Physiology or Medicine earlier this week.
The amendments’ supporters had good intentions and the regulations have had positive effects overall. Yet the US government is still trying to redress many of their negative consequences. The rules have proven to be outmoded for new circumstances that policymakers did not have in mind when they created the amendments five decades ago.
The four-phase review process requires that manufacturers apply to the FDA and submit drugs for agency review three times—at least. One consequence of the four-phase review system is that it extended the time until consumers could access new therapies. This can seem a small price to pay to assure that drugs are safe and effective, a phrase that has become the slogan for the Amendments. People with new, fast-moving diseases, however, have seen the delay as a death sentence. For example, sociologist Steven Epstein has written extensively and carefully about the response to drug delays in the 1980s and 1990s among the HIV/AIDS activist community. The FDA has responded with changes, such as a fast-track approval system, but these shifts tend to come only in response to dire crises.
Upcoming Event – Frank Miller on Placebo-Controlled Trials Before Informed Consent
What were they thinking? Placebo-controlled trials before informed consent
Franklin G. Miller, Ph.D., Department of Bioethics, National Institutes of Health
October 25, 2012 – 4pm
Shapiro Clinical Center JCRT 5A (East Campus), Beth Israel Deaconess Medical Center, Boston, MA
Sponsored by the Program in Placebo Studies and the Therapeutic Encounter; Martinos Center for Biomedical Imaging; MGH; BIDMC Division of General Medicine and Primary Care; HMS Department of Global Health and Social Medicine
For more information call 617-945-7827
You must be logged in to post a comment.