Wednesday, April 19, 2006

snatched from the Morning Mail

What are you doing next Saturday? I hope I'll be in Petteruti.

From: "Anne Fausto-Sterling Ph.D"
To: All Students, All Faculty

Subject: Science in the Public Eye: An Exciting Symposium


Save the date!! April 29th 10 to 4, "Science in the Public Eye" Petteruti Lounge.

10 am: "Must the Media Always Inflame Public Controversies about Science?"

11:15 am: "Mining in the West: Who Pays for the Cleanup?"

1:30 pm: "Impertinent Questions and Bloody Fingers"

2:45 pm: "Teach Globally, Learn Locally: Telling Universal Stories about Particular Places"

Moderator: Catherine Imbriglio, Brown University

More info: http://www.brown.edu/Faculty/COSTS/events.html

Friday, April 07, 2006

Numbers of Child Psychiatrists Low

CNN recently reported on what it calls a severe lack of child psychiatrists in America. The article, for which Dr. Gregory Fitz of Brown Medical School was interviewed, explains that every state suffers a shortage of child psychiatrists (based upon need projections by the U.S. Bureau of Health Professions). Wyoming, for example, has only two child psychiatrists.

The low numbers of child psychiatrists has been attributed to the training and work requirements associated with the field. For one, the training for child psychiatry is longer than that for general psychiatry. Furthermore, some practitioners lament the increased time needed to counsel both patients and their parents. Child psychiatrists are not compensated for the additional time associated with the field.

The decrease in the numbers of child psychiatrists raises interesting questions. Student bioethicists at Brown have, for some time, debated the practices of child psychiatrists (including the use of antidepressant medications in children). In a number of situations, students have concluded that psychiatry in general (and child psychiatry specifically) ought to reevaluate its practices. Therefore, it may appear almost positive that the numbers of child psychiatrists have decreased.

This viewpoing is probably both simplistic and dangerous. Indeed, the lack of child psychiatrists ought to be perceived as a problem even for those who question the behavior of some psychiatrists. For one, we should note the recognized importance of child psychiatrists in particular circumstances, including child abuse and trauma.

Furthermore, our recent dearth in child psychiatrists should raise general concerns regarding the number of juvenile and adolescent-specific clinicians in our country. If, for practitioners, juveline practice is more expensive than adult practice, and if training for juveline practice is more extensive than it is for adult practice, then we ought to consider providing incentives for studying juvenile practice. Might there be particular government incentives for entering into pediatric medicine to offset the added training and work associated with counseling both a patient and his or her family members?

What's more, this may be a fruitful time for individuals who protest the practices of child psychiatrists to propose alternatives to drug therapies for children. The lack in child psychiatrists means that many children receive no counseling, diagnosis, or treatment. If alternatives to drug practices are indeed beneficial for children (and if empirical support exists backing these claims), then we ought to see serious proposals for the inclusion of alternatives to drug therapy in insurance programs, government medical programs, etc.

Our current lack in child psychiatrists may be a dangerous thing, even if psychiatry suffers from its own lapses in standards of practice. It may signify a more general problem regarding pediatric care. During this dearth in the numbers of psychiatrists, it would be beneficial for both children and their families to have available at their disposal alternative treatment options. If these treatment options display standards of practice that are more empirically supported and objectively applied than are the standards of practice of pscyhiatry, then we will have transformed a period of deficiency into one of progress.

Wednesday, March 15, 2006

This is why Bioethics needs to stick around...

These three headlines were all taken from CNN Internationl on one single day. These are the reasons that bioethics exists and needs to remain.

http://edition.cnn.com/2006/HEALTH/03/15/uk.clinical/index.html

http://edition.cnn.com/2006/LAW/03/15/court.baby.reut/index.html

http://edition.cnn.com/2006/LAW/03/14/body.parts.ap/index.html

While some of these stories are obviously far out of the ordinary and what seem to be out of a bad horror film, the ethical issues involved are blatant. Everyday we are confronted with new issues that seem "out of the ordinary" within biomedicine and ethics and it is for these issues that bioethics exists.

Monday, March 13, 2006

For an orphan drug, yet more buck for the bang

Not to be outdone by Genentech, the small pharmaceutical company Ovation has upped the price of its orphan drug Mustargen nearly tenfold. The zinger? Mustargen's patent expired decades ago.

Mustargen, known generically as nitrogen mustard, is an old chemotherapy agent now used mainly as a topical therapy for cutaneous lymphoma. The appellation 'generic' is a bit of a misnomer, however: because of Mustargen's relatively small market (it grossed only $546,000 nationally in 2004), no other drug company finds it profitable to produce a generic competitor. Hence, Ovation can charge whatever it likes for the drug.

For those who sense predation in Ovation's change of heart, fear not. The increase in costs, according to a company executive, is necessary to invest in manufacturing facilities for the drug. (Ovation, in a stroke of entrepreneurial genius, recently acquired the rights to the drug from Merck, who, in the meantime, is providing the company with a steady supply.)

Yet again, price gouging is justified on the basis of phantom production costs. The hidden argument, of course, is one that is becoming more explicit day by day: drugs ought to be priced on the basis of their intrinsic value as life-sustaining therapies -- not on their research, development, or even marketing costs.

The argument is troubling. Its language implies universality; any reasonable person ought to realize the "intrinsic value" of drugs. (And there is arguably a price which everyone, or nearly everyone, might be willing to pay for the continued existence of life-sustaining therapies.) Unfortunately, "intrinsic value" here is determined based on price optimization in the marketplace, which is contrary to universal access. If consumers are desperate enough -- and in the special case of cancer patients, arguably they are -- price optimization may occur at a point where most consumers are priced out of the marketplace.

If drug companies were selling lemonade, that might be legitimate. But many of us, soft-hearted folk, treat life-sustaining health care as a special case: a social benefit to which even the poor and elderly are entitled. If not, wherefore Medicare and Medicaid?

This situation is also a reminder of the cozy regulatory situation drug companies find themselves in. Medicare, for example, is forbidden from taking into account a drug's price in determining coverage. While this protects healthcare consumers from the (fictional) possibility of cheap drugs being substituted for good ones, it also prevents Medicare from using its enormous purchasing power as leverage in favor of reduced prices. Until the inferiority myth about generics is debunked (see Marcia Angell's excellent book on the subject), Medicare will continue to operate with one regulatory hand tied behind its back.

As for Ovation, may they continue to, in their own words, "satisfy unmet medical needs." We're rooting for you.

Friday, March 10, 2006

The Academy's Obligation to Embrace Bioethics

We are now in the wake of the recent Brown Bioethics Society's lecture by Sheldon Krimsky, where members of the Brown community confronted the sometimes dark, nonobjective nature of contemporary scientific practice as it exists in our academies. The problems introduced by the lecture welcome a storm of questions, the most significant of which may be, “Where do we go from here?” Members of the bioethics community at Brown have been grappling with this question for some time. Here, I provide my own take on scientific reform by briefly examining science’s sister field – medicine. (My argument here is written in anticipation of a forthcoming article that will appear in the Triple Helix's e-journal).

The 20th century brought with it a rapid modernization of the medical discipline. As physicians became more powerful and medicine became more of a presence in society, institutions of medical education embraced medical ethics curricula. This move came as society expressed its interest in training doctors who were not just smart, but good. Good, here, has a clear normative connotation. Nowadays, we have serious reason to question the legitimacy of any medical education program that omits medical ethics from its curriculum. We ought to question the values of such an institution.

However, it is important to note that the 20th century also brought with it a rapid modernization of scientific inquiry. This modernization has increased the presence of scientists in our society, and has (arguably) granted more power to scientists. As science became more advanced, it became less intuitively clear to the public and therefore had an increased chance of operating in isolation of the wants and needs of society. In this way, it gained power that it would not otherwise have had. (Inadequate science education may also be to blame for this inaccessibility). This modernization also inundated society with scientific advances and innovations, including scientific advances in medicine. In any situation where one institution has the ability to harm or benefit members of the public who themselves are not privy to the knowledge of that institution, we ought to ask ourselves, "How should members of this institution operate? What should they be permitted to do? What should they not be permitted to do?"

Just as the 20th century saw medical ethics' establishment as a discipline concerned with addressing these questions as they relate to medicine, bioethics has emerged to answer the same questions for the scientific community. However, even as society puzzles an increasingly more powerful, isolated scientific community, our research institutions and academies have not fully embraced the need for bioethics in their curricula. Although medical ethics is perceived as being necessary for physicians’ training, we do not actively promote a similar requirement for researchers. These two sister fields are thus held to very different standards of practice.

The idea that a research institution that trains thousands of undergraduate and graduate scientists, preparing them for professional research, lacks a program in bioethics ought to worry the public. If academies lack bioethics programs, then how can we be sure that the next generation of researchers is being taught “good science”? Are we to blindly trust the members of the scientific community? A growing body of evidence, including examples cited by Sheldon Krimsky, suggest that this sort of blind trust in academic science may not be safe.

The move to ensure that physicians have ethical training was an important one. We should now expand it to include all individuals who will conduct scientific research. Those scientific research institutions that have yet to establish undergraduate and graduate programs in bioethics ought to be compelled to do so by established advisory panels, public organizations, and representatives of the public (including governmental officials). The very small list of schools moving to dissolve their bioethics programs ought to be chastised for their disregard for public needs. Scientific research academies that neglect ethical inquiry as a component of scientific training ought to be granted the same prestige as are medical schools that neglect the ethical training of their physicians. Institutions of this type embrace an “old curriculum” befitting the days when medical paternalism was the unquestioned law of the land. Now is the time for out with the old and in with the new.

Thursday, March 09, 2006

Engineers say...

In a letter to the Brown Daily Herald, students from Brown's Biomedical Engineering Society claim that bioethics is "essential to a 21st century liberal education" and "might help us to serve the world better." Among their more outrageous insinuations is that the entire Brown student body -- not just bioethics geeks -- might benefit from the continuation of the program. Finally, given these so-called observations, they term Brown's decision to cut the program "irrational."

I couldn't disagree more.

Sunday, March 05, 2006

big pharma does india

What is the German pharmaceutical company Boehringer Ingelheim doing in the small town of Sevagram, India?

The answer is in this month's Wired magazine, which covered a (now familiar) story on the outsourcing of clinical drug trials. This particular story is about the stroke-prevention drug Aggrenox. Boehringer has set up 28 trial sites in India; they are offering participants 2 physicals per year for 3 years (the length of the trial) and 30,000 rupees (about $665) to participating hospitals. The drug has been described as having "possible side effects and limited efficacy."

But why India? Well, with a population hovering around the 1 billion mark, India offers a resource America is running out of: willing research subjects. What's more, many of the people signing up for the trials are poor, illiterate and "treatment" naive (which limits the possibility of adverse interactions between drugs). Where American doctors have become suspicious of big pharma and their tickets to Hawaii, many Indian doctors see participation in the trials as a great opportunity for them, their patients, and their hospitals. The benefits to both sides seem apparent.

Perhaps one of the most controversial elements of this story, however, is the issue of informed consent. The article focuses on the experiences of Dr. Kalantri, who describes his patients as passive recipients of their health care. Indian consumers are not "educated" about drugs or health issues like Americans. Medications are not household names in India, but foreign bodies with miraculous mechanisms. Similarly, doctors are revered in many parts of India. Kalantri writes,

"Nine out of 10 times, the patients will just ask me to make the decision for him. So what role do I play? Am I a physician, concentrating on what's best for the patient? Or am I a researcher interested in recruiting patients? I try to balance the two sides but...it's a dichotomy."

The doctor is clearly in a bind, asked to make difficult decisions on his patients' behalf, who don't even know the basic science required to make educated decisions.

Another issue is that the drugs being tested are irrelevant to the true health concerns of a country like India. As Kalantri explains, "finding better treatments for osteoporosis and high cholesterol is important...but these are diseases that will cause problems at 40 or 50. Infectious disease like malaria and filariasis kill at 20 and they're much more common here." Health care in India just isn't ready for large-scale preventative measures. Before they are ready to work towards creating a health country, they need to tackle diseases that we just don't see much of here.

Maybe it's my deep love for India or maybe it's my deep (cough) hate (cough) of drug companies, but something about this makes me very uncomfortable...

Wal-Mart bows to Plan B. Sort of

In response to political pressure from state governments, Wal-Mart has announced plans to carry Plan B in its 3,700 pharmacies nationwide.

With a catch: under a conscience clause, pharmacists will retain the right to refer customers seeking Plan B to another pharmacist -- or, if they are the only available provider, to another pharmacy altogether.

Wal-Mart's press release claims the right of conscientious objection to be "consistent" with the tenets of the American Pharmaceutical Association. And it is. In testimony before the House in 2005, association member Linda MacLean clarified APhA's policy:
APhA's policy supports the ability of a pharmacist to opt out of dispensing a prescription or providing a service for personal reasons and also supports the establishment of systems so that the patient's access to appropriate health care is not disrupted [...]  [O]ur policy supports a pharmacist 'stepping away' from participating but not 'stepping in the way' of the patient accessing the therapy.
The distinction between "stepping away" and "stepping in the way" is well and good for those of us who live near pharmacies not named Wal-Mart (or Sam's Club). But what about towns where Wal-Mart is the only pharmacy around (given that they've driven local pharmacies out of business)? Towns where the moral climate brings public hostility to bear on pharmacists? The options for poor, young, or uneducated women -- arguably, those most likely to seek emergency contraception -- start to look exceedingly slim.

Wal-Mart's change of heart is a fan-friendly one. Just not to those who need it most.

Friday, March 03, 2006

supplementary material

We're not dead yet and neither is our press coverage. Check out today's Editorial Cartoon in the Brown Daily Herald.



Tuesday, February 28, 2006

Last words on Brown bioethics

As the undergraduate bioethics program at Brown lurches towards oblivion, it's nice to know that we're at least getting some free press over it.

The Brown Daily Herald has published a news article on the demise of the concentration.   And if you thought that wasn't enough, they've also managed to print an opinion piece (read: partisan propaganda) written by a few of us challenging the university's apathy towards bioethics.

For more reading, check out last year's entry in the AJOB editors' blog bidding farewell to Brown bioethics.

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