April 23, 2013; 12:00-1:30pm
Department of Health Care Policy
Harvard Medical School
180 Longwood Avenue
Boston, MA 02115
For more information, contact Dr. Barbara McNeil
One of my primary areas of research is in conflicts of interest (COI). I generally focus on the financial relationships between physicians/researchers and the pharmaceutical industry. See Here Here and Here.
However, COI researchers and policy makers need to expand our scope to include other health care professionals who have relationships with other key health care industries, other than pharma and device companies. In this blog, I focus upon the relationships between discharge planners and long-term care providers (including home care, skilled nursing facilities and others). Long-term care is a growing part of health care expenditures, and represents an area where patients’ preferences and best-interests should be the primary obligations of discharge planning professionals — who are not biased due to industry marketing.
As I reflect back upon my almost two decades in health care, as a clinician, researcher and bioethicist, I am amazed at how pervasive marketing activities are in hospitals… other than seeing drug reps visiting doctors (in fact, this was banned in the hospital I worked). For example, during my first clinical internship, at a rural hospital near Atlanta, home care agency marketing reps were often bringing food and providing educational/marketing materials to the Case Management/Social Work office. We all hung out together. Same thing happened in NYC; although I was not directly involved in discharge planning, home care and post-acute care providers bestowed small gifts, food and other marketing materials – obviously, with the hope of building goodwill, and hoping that as a clinical social worker, I would indirectly influence referrals to their businesses. In addition to gifts and marketing, representatives from these health care companies were often ever-present in the inpatient units to help the Case Managers and other clinicians with the necessary paperwork, insurance reviews, and overall referral facilitation. From what I understand, this type of post-acute care industry “detailing” still occurs in American Hospitals with frequency.
Glenn Cohen and Eli Adashi have an interesting Sounding Board piece in the latest NEJM[i] on made-to-order embryos for sale. A California clinic offering this option has garnered enormous publicity. It might, however, have stimulated more bioethical thinking than actual demand for its services.
On the bioethical side, Glenn and Eli survey the relevant issues and conclude that what is most “new and unique here is the lack of clear legal guidance as to the parentage of the embryos in question.”[ii] My impression is different– existing laws give sufficient support about parentage, if anyone wants to use them. The clinic creating the embryos from separate gamete donations will have dispositional control of them, but no parenting questions arise until the embryos are gestated and brought to term. True, there are few state laws on embryo donation as such. But in states with no specific embryo donation laws, those who have commissioned gestation will most likely have rearing rights and duties once a child is born until they arrange for an adoption.[iii]
Nor would the gamete donors in such states be able to claim rearing rights or be subject to rearing duties after such a birth. Most states recognize gamete donor relinquishment of rearing rights and duties in resulting children with their consent to donation. After the birth of a child, the gamete donors ordinarily would have no right to change their mind and acquire rearing rights or be subject to rearing duties, whether the donation was of sperm or egg separately or both combined into an embryo.
One aspect of this transaction that is ethically unique is that divvying up embryos created from the same egg and sperm donor would lead to different recipients giving birth to full rather than half siblings, as is the usual situation with gamete donation (it could happen with excess embryos donated after successful IVF by an infertile couple, but that is rarer). Whether it creates a higher risk of full sibling consanguinity would depend on clinic practices in distributing embryos from the same batch to different recipients. As Glenn and Eli note, donor registries might solve this problem, but none yet exist in the United States.
By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight. Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of the problem may have been a result of the difficulties associated with approving multi-site research.
Maybe so, but let me offer a more fundamental challenge: perhaps IRBs are just ineffective – or not as effective as we hope they would be – at protecting human subjects. In retrospect, it looks like all 23 IRBs that reviewed the study, all of which were applying the same regulatory standards, failed to do what OHRP, many news outlets, and as awareness grows, much of the public thinks they ought to have done to protect the babies and families involved in this study. How could they all have gotten it wrong? Are the regulations insufficient? Are the procedures insufficient? Is it all just a matter of interpretation?
These questions lead to another fundamental issue: the lack of empirical evidence on IRB effectiveness. We have data on whether IRBs follow the regulations, data on adverse events, data on OHRP warning letters, data on IRB-imposed research burdens and delays – but these all nibble around the edges of the real questions: what are IRBs supposed to be doing, are they doing it well, and how would we know? The counterfactual – a world without IRB review – is pretty tough to study, but I’m working with a group of colleagues at the Petrie-Flom Center and elsewhere to think through some empirical methods to get at precisely these issues. And we’d love to hear your thoughts!
Finally, as a side note, one point that seems to be getting lost in coverage of this preemie story is that although there seems to have been some major problems with the consent process, the study question itself was a very important one to ask.
Institutional Review Boards are in the top news at outlets such as the New York Times, as a research debacle unfolds. I looked through the documents that are publicly available to figure out what happened and what to expect.
Researchers at 22 universities or hospitals in the US enrolled premature babies in a randomized controlled trial between 2004 and 2009. This was the second part of a broader study, but the first part of the study “raised no concerns” according to the US Office of Human Research Protections on page 2 of its determination letter to the lead institution, University of Alabama-Birmingham. OHRP is the federal agency in charge of enforcing human-subjects regulation.
For the second part of the study, though, OHRP found that all 23 IRBs that approved the study (at 22 research sites) violated federal regulations: IRBs should have made researchers tell the parents that they knew their babies would be at higher risk of death, neurological damage, or blindness if they enrolled in the study (pages 2 and 10 of UAB letter). OHRP has only posted a determination letter for UAB at this point, but it explains that at all of the sites, the agency found violations with consent documents “similar to those described” to UAB. The UAB IRB is in especially hot water because it seems first to have first approved the 2.5-page template consent form, which the other institutions used (page 5). If you read the last page of UAB’s letter, you can make a good guess at who may officially be getting bad news from OHRP soon.
Ed. Note: We continue to experience difficulty with our comment function. While we work to get this fixed as quickly as possible, please send any comments you would like posted to hlynch at law dot harvard dot edu.
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By Adriana Benedict
Last week, Ryan Abbot blogged here about the Novartis case decided last Monday by the Supreme Court of India. Since then, there have been a broad range of reactions to the case, but many of them appear to have left a lurking elephant in the room.
I’d like to attempt to provide some clarity to a question that seems to have created a lot of confusion surrounding the impact of the Novartis decision: If the older alpha crystalline form of imatinib mesylate (generic Glivec) is already available in India, and the newer beta crystalline form is not more therapeutically efficacious, then why does it matter whether or not Novartis can get a patent on the newer version of Glivec? The simple answer is that for the most part, it doesn’t really, in terms of the availability of generic Glivec. At most, it may make a difference for some Indian patients who will do better with the beta crystalline form. And it will make some difference for Novartis, which will now forego a potential market of these Indian patients who would prefer to take (and can afford to pay for) the beta crystalline version. But the alpha crystalline form of imatinib mesylate was already available in generic form in India, and it would have continued to be available in generic form in India regardless of the outcome of this case. So why all the commotion?
First, the Novartis decision means that Indian generic manufacturers can now produce the beta crystalline form of imatinib mesylate with impunity. This means that Novartis is likely to face competition in its production of the beta crystalline form, over which it would otherwise have held a global monopoly. Indian generic manufacturers may now produce and export the beta crystalline form to other countries, which means that many more cancer patients in developing countries will have access to it. Novartis’s markets in these countries may be disrupted through parallel importation of cheaper generics.
The New England Journal of Medicine just published a new article by me (and my frequent co-author Dean Eli Adashi) entitled “Made-to-Order Embryos for Sale — A Brave New World?” As we note in the article:
The proliferation of commercial gamete sources (e.g., sperm and oocyte banks) has opened the door to a made-to-order embryo industry in which embryos are generated with a commercial transaction in mind. This prospect of a for-profit embryo bank is no longer theoretical. Indeed, as recently as November 2012, the Los Angeles Times reported on one such clinic that “sharply cuts costs by creating a single batch of embryos from one oocyte donor and one sperm donor, then divvying it up among several patients.” The report went on to state that “the clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.
The paper then analyses the legal and ethical issues raised by the development of these kinds of banks. In so doing, a key question we ask is how this practice is similar or different from embryo donation (sometimes called “embryo adoption”), the sale of sperm and eggs for reproductive purposes, and the use of sperm and egg to produce stem cell lines that require embryo destruction.
This one is sure to be controversial, and while this short piece in the New England Journal is now published I would love to hear readers’ thoughts as I may write more on the subject.
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