Category: Doctor-Patient Relationship

Conflicting Interests in Research: Don’t Assume a Few Bad Apples Are Spoiling the Bunch

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by Suzanne M. Rivera, Ph.D.

In August of 2011, the Public Health Service updated its rules to address the kind of financial conflicts of interests that can undermine (or appear to undermine) integrity in research.  The new rules, issued under the ungainly title, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” were issued with a one-year implementation period to give universities and academic medical centers sufficient time to update their local policies and procedures for disclosure, review, and management (to the extent possible) of any conflicts their researchers might have between their significant personal financial interests and their academic and scholarly activities.

The rules were made significantly more strict because a few scoundrels (for examples, click here, and here) have behaved in ways that undermined the public’s trust in scientists and physicians. By accepting hundreds of thousands, even millions, of dollars from private pharmaceutical companies and other for-profit entities while performing studies on drugs and devices manufactured by the same companies, a few bad apples have called into question the integrity of the whole research enterprise.  This is a tremendous shame.

Having more than one interest is not bad or wrong; it’s normal.  Everyone has an attachment to the things they value, and most people value more than one thing.  Professors value their research, but they also want accolades, promotion, academic freedom, good parking spots, and food on their tables.  Having multiple interests only becomes a problem when the potential for personal enrichment or glory causes someone (consciously or unconsciously) to behave without integrity and compromise the design, conduct, or reporting of their research. Read More

Upcoming Event – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

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Monday, November 5, 2012
12-1:30 pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1

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It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week.  Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics?  I think this may be the case.

Perhaps most importantly, frozen oocytes will not implicate personhood laws.  Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses.  However,  IVF clinics and clinicians should also be concerned.  It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos.  There have been no such criminal proceedings brought against an IVF clinic — yet.  Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist.  Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.

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Raffles for IVF Access?

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By Nir Eyal

As the New York Times reports (quoting me on the ethics), some American IVF clinics are now running raffles where the prize is IVF services. The contests give clinics publicity and sometimes serve charitable causes. Are IVF raffles unethical? Should we ban them?

Gambles and contests over the ability to have babies represent a new level of commodification—if you will, a new frontier. But they are not always unethical. Clinics do not owe infertile couples free access to IVF services. In some cases, the state and insurers don’t owe it to them either—legally or morally. IVF is expensive and some medical services are needed even more badly. Uninterested couples can avoid these raffles. What these raffles do is to give infertile couples opportunities that they would lack otherwise for obtaining an important benefit, opportunities that go beyond what clinics owe them. Lotteries, in particular, are not necessarily unfair means of distributing resources. Some philosophers deem them very fair. Even when couples with means can buy several raffle tickets, impoverished couples still get better chance of IVF access than under the current system. Money speaks, but it speaks less vocally than in much of American healthcare. In this respect, these raffles are a good parody of our unjust system.

 These contests are games. Conservatives worry that they take infertility or the beginnings of human life too lightly. But light-heartedness could be a good thing in this area. It might reduce the anxiety and the stigma that too often accompany infertility treatment. Associating the conception of new human life with fun? Traditional procreation can do that, too!

In short, not everything that’s odd is unethical. Notwithstanding initial “yuck” feelings, raffles for IVF access are not always morally wrong. It would have been morally more ideal if clinics offered free IVF services to everyone, or prioritized the neediest and the underserved, or gave rich and poor equal chance. But acting less than ideally is not doing wrong. Read More

Abortion, Circumcision, and the Politics of Documenting Informed Consent

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Last week, as the New York Times reported, a fight over documenting informed consent to a particular Jewish circumcision ritual is brewing. To quote from the article:

The city Board of Health passed a regulation in September that required written parental consent before a ritual circumcision could be done. In the procedure, common among ultra-Orthodox Jews, the person performing the circumcision uses his mouth to remove blood from the incision. The oral contact, known in Hebrew as metzitzah b’peh, is considered dangerous by public health officials, because of the possibility of spreading diseases, specifically herpes. Failure to comply with the regulation could result in warnings and fines.

To be clear the New York City Board of Health has NOT outlawed the procedure, despite its herpes risk. Instead it only requires that written parental consent be given. My first reaction, and I suppose the reaction of many, is “what could possibly be wrong with that?”  On reflection, though, I began wondering what might be learned by juxtaposing this requirement against another one that is trying to influence parental choice…laws on informing women about the risks of abortion and requiring the offering or viewing of an sonogram.

As John Robertson, among others, has recently detailed:

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The Limits of Advance Directives

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By David Orentlicher

While it is important for people to express their wishes about end-of-life care in advance, a court case in Hawaii reminds us that advance directives do not always ensure that patient’s wishes will be followed. Karen Okada wrote a living will, which the hospital ethics committee found to express a desire not to have a feeding tube in her current condition. A family member has objected, on the basis that he is acting in accordance with his authority as an appointed surrogate. Unfortunately, patients’ preferences can be frustrated by their families or their health care providers.

[Cross-posted from HealthLawProf Blog]

Quality Control on the Back-End via the ACA and on the Front-End via Tort Litigation

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By Vickie J. Williams

I am back after a brief hiatus for the Jewish holidays. L’Shanah Tova to all my readers who have just celebrated the Jewish New Year.

The first Monday in October is, of course, a special day for all of us legal eagles–the Supreme Court is back in session. The other significant thing about October 1 for those interested in health law is that hospitals will now be fined if too many of their Medicare patients are readmitted within 30 days of discharge due to complications. As reported by the Associated Press, this is part of the Affordable Care Act’s push to incentivize quality improvement while trying to save taxpayers money. Right now, admissions for only three medical conditions are subject to the penalty: heart attacks, heart failure and pneumonia. Penalties are held to a maximum of 1% of the hospital’s Medicare payments for now, but will rise to a maximum of 3% of Medicare payments over several years. This attempt to control quality of care on the back-end constitutes a marked contrast with the way reimbursement policy has worked over the last several decades to discourage hospitals from keeping patients in beds for “social” reasons, such as having nobody to care for them at home if they are discharged. Many Medicare hospital readmissions are due to non-compliant behavior by fragile patients with few resources to help them once they leave the hospital, something that is not really subject to the hospital’s control, and says nothing about the hospital’s quality of care for the patient. For decades, Medicare payment policy, which generally pays hospitals the same amount for caring for a patient regardless of how long he or she is in the hospital, has encouraged speedy discharges. This is touted as a way to save costs. Apparently, the new policy on payments for readmission is an acknowledgement that there is both a financial and a human cost to treating medically and socially fragile people in the express lanes of health care. It remains to be seen whether the penalties result in better quality care, or significant savings, but surely they will result in increased work for hospital social workers and discharge planners. Read More

Would you rather medical school train your PCP to have good hands or a good bedside manner?

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Last week NPR covered a story highlighting how medical education is morphing in order to adapt to the unmet demand for primary care physicians driven (at least in part) by the increased access to primary care that will be ushered in under the ACA.  It may be surprising to some to learn that many of the most prestigious medical schools like Johns Hopkins and Harvard do not have a primary care program; however, as reported by NPR, medical schools may soon rethink this hole in their curriculum in the face of changing demands upon the health care system and its accompanying incentives for young physicians to enter primary care.   Mount Sinai School of Medicine is leading the way in this regard by launching a new department of family medicine in June.

Intuitively, changing the medical education system to produce more primary care physicians will further goals of the ACA by increasing access to primary care, and therefore improving overall public health and diminishing cost by decreasing emergency room care for conditions that could have been treated less expensively or avoided altogether by increasing access to preventative services.  These are the arguments we’ve heard repeatedly by the champions of the ACA and by the Obama administration, particularly through its vision for the Prevention and Public Health Fund which was intended to bolster the pipeline of primary care physicians before being gutted earlier this year.

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The Use of Electronic Health Records Is Increasing Medicare Billing: Is It Also Increasing the Amount of Care Physicians Provide?

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 By: Katie Booth

The New York Times recently reported that the switch to Electronic Health Records (“EHRs”) may be contributing to rising Medicare costs. The Times described two hospitals where the portion of patients billed at the highest reimbursement rate rose by over 40% when the hospitals adopted EHRs. The Times also reported that in hospitals that switched to EHRs between 2006 and 2010, Medicare payments rose 47%. Medicare payments for hospitals that did not adopt EHRs rose 32%.

There are several potential explanations for this increase in billing. One is that doctors are simply doing a better job electronically recording the same care they’ve always given, leading to higher Medicare billing. Another is that some doctors are abusing the EHR system by upcoding patients or copying and pasting examination histories, fraudulently increasing Medicare billing.

A third explanation is that EHR systems actually change the way doctors practice medicine. In the process of asking doctors for particular data points, EHR systems may remind doctors to look for particular symptoms or to provide particular treatments that doctors may not have considered otherwise. It is thus possible that EHRs have led to higher Medicare bills because they have increased the amount of time doctors spend diagnosing and treating patients.

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The Fallacy of Fearing “Industrialized” Medicine

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By Patrick O’Leary

Looking back over last month’s health-related news, two articles published on The Atlantic’s website stand out to illustrate a tension that has received a great deal of focus in Medicare reform circles, and that seems to be a political sticking point for many otherwise promising cost-reduction strategies. In his September 10th article The Fallacy of Treating Health Care as an Industry, Professor Gunderman of Indiana University criticizes a recent Institute of Medicine (“IOM”) report suggesting that our medical system could be providing better care at lower cost if it could only learn a few lessons from other industries. Professor Gunderman’s critique invokes the specter of mechanical medicine: an “industrial assembly line approach to medicine” where the pursuit of efficient care utterly eclipses the human element, the “communication and relationships” that make the practice of medicine more than just an industry. Similar arguments can be and have been deployed against any resource-sensitive reform of medical practice, as the “death panels” debate from several years ago well illustrates.

While these kinds of human-relationship based critiques of efforts to make medical care more efficient may be relevant in the context of more extreme proposals of medical rationing, they are misguided as applied to recommendations like those made in the IOM report. Read More