The company, Osiris Therapeutics of Columbia, Md., said Thursday that Canadian regulators had approved its drug Prochymal, to treat children suffering from graft-versus-host disease, a potentially deadly complication of bone marrow transplantation.

“It’s really a good day for the concept and the hope behind stem cell therapies becoming a reality,” C. Randal Mills, the chief executive of Osiris, said in an interview.

Prochymal is a preparation of mesenchymal stem cells, which are obtained from the bone marrow of healthy young adult donors. The stem cells are separated out from the marrow and expanded in culture, so that one donation is enough to make as many as 10,000 doses.

Because these are adult stem cells, they do not raise the ethical concerns of embryonic stem cells, whose creation usually involves the destruction of human embryos.

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A new law in Pennsylvania has doctors nervous.

The law grants physicians access to information about trade-secret chemicals used in natural gas drilling. Doctors say they need to know what’s in those formulas in order to treat patients who may have been exposed to the chemicals.

But the new law also says that doctors can’t tell anyone else — not even other doctors — what’s in those formulas. It’s being called the “doctor gag rule.”

‘I Don’t Know If It’s Due To Exposure’

Plastic surgeon Amy Pare practices in suburban Pittsburgh where she does reconstructive surgeries and deals with a lot of skin issues. She tells me about one case, a family who brought in a boy with strange skin lesions.

“Their son is quite ill — has had lethargy, nosebleeds,” Pare says. “He’s had liver damage. I don’t know if it’s due to exposure.”

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This unease with linking religion to bioethics also leads to advice such as “stick with secular principles and human rights” or “getting into religion will get you nowhere except into trouble.”

Such comments reflect an understanding of bioethics as a rational, philosophical discipline that can provide a common morality, universally understood and globally applicable, and which can transcend other value systems. Nevertheless, this is an existential issue for a bioethics center located in a country with 165 million Muslims. What should be the aims and functions, the raison d’être, of such a center in a country with tremendous cultural, ethnic, linguistic, and educational diversity and yet hierarchical, religious, profoundly family-centered lives in which for many right and wrong, good and bad, in personal, public, and professional interactions are grounded in Muslim values and longstanding cultural norms? Pakistan is a different world from the United States, the cradle of contemporary bioethics in which I received my surgical training and education in bioethics.

Contemporary bioethics was imported to Pakistan in the mid-1980s by members of the medical community, many of whom had trained in America. It was in effect a feat of transplantation rather than an indigenous phenomenon seeded and nurtured through societal discourse. The dominant paradigm that took root was Beauchamp and Childress’ principlism, which appeared, and still does, in lectures and workshops structured around the easy to remember, popular with Pakistani physicians, mantra of autonomy, beneficence, nonmaleficence, and justice.

Over subsequent years however, some of us began to see the irony of giving lectures (in English) in the morning to students and residents on the use of philosophical principles (with autonomy as the trump) for framing ethical issues, and then switching in the afternoon to clinical care of a public who spoke in Urdu, made collective decisions when kin fell ill, preferred to address us with relational terms used for family “elders” – their maa/baap(mother/father) or baji (older sister) – or doctor sahib (a suffix for someone in a higher position), and perceived us as “instruments of God’s mercy” to direct them in what they should do.

See Also: Our Bulletin Post “Islamic Bioethics“

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This evening, my colleagues and I published a paper in the New England Journal of Medicine that established that the FDA is approves drugs faster than its counterparts in Europe and Canada. Based on a careful review of applications for novel therapeutic agents approved from 2001 through 2010, we found that the FDA was almost two months faster than the European Medicines Agency and Health Canada. Moreover, the majority of the agents that we evaluated were approved first in the United States.

That paper, which was led by Nick Downing and Joe Ross, provides objective information about the FDA’s performance, defending against concerns that the evaluation process in the US is encumbered by excessive delays. The fact that we are faster does not mean that we cannot do even better – or that faster is always better. However, in cases where lifesaving drugs are being proposed and there are no good alternatives, our current speed, while faster than others, may not be fast enough, meriting further improvements in accelerated approval.

As these discussions proceed, this report provides some context to discussions about what the FDA is achieving – which may be useful in the midst of discussions on Capitol Hill about the Prescription Drug User Fee Act, which is designed to make the process more efficient.

While the approval speed will give comfort to many who are concerned about delays in getting new drugs to market, this week’s New England Journal of Medicine has another article that raises some concerns in another area.

In a well done study of patients covered by Tennessee Medicaid, scientists are reporting that azithromycin is associated with an increased risk of cardiovascular deaths.

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