Bioethicists Alice Dreger and Ellen Feder have raised a stir with scathing accusations against two doctors — a pediatric urologist and a pediatric endocrinologist — for what they say are serious violations of human research protocols.

Most of the ire has been directed towards Dix Poppas, a surgeon at Weill Cornell Medical School in New York, who treats young girls with ambiguous genitalia, often as a result of a disorder of the adrenal gland known as congenital adrenal hyperplasia (CAH). Poppas’ technique, which he says preserves a higher degree of nerve function, removes tissue from the shaft of the clitoris in order to reduce it in size. The medical necessity of clitoroplasty has come under scrutiny in the past decade, and many decry it as a form of genital mutilation, but it is still an accepted standard of care.

The other aspect of the controversy has centered around Poppas’ follow-up exam procedure, in which the child’s post-surgery sensitivity is measured by using a vibrator on the thigh, labia and clitoris. Even putting aside the question of the psychological effect on the patient, Dreger says that Poppas’ decision to publish a paper on this new surgical technique was experimental research that, she alleges, was not approved by an institutional review board. (Poppas and the Cornell IRB have not responded to Nature Medicine’s requests for comment.)

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Cross posted from Nature’s The Great Beyond blog.

In a much-anticipated decision, the US Supreme Court has struck down a patent that became ensnared in arguments over what should and should not be patentable. But the court’s decision seems to carefully sidestep that broader discussion – and the implications it could have held for gene patents.

All year, the biotechnology industry has been waiting with bated breath for a ruling in the case Bilski v Kappos*. Although the case dealt with the patentability of a method for trading commodities on the energy market, many felt the ruling would have implications for the practice of patenting processes, including gene testing.

Read the rest of the post on The Great Beyond.

* For more on the Bilski v Kappos case, read our news story from last year.

Doctors in Massachusetts may once again be allowed to receive any type of promotional gift from drug companies if a new bill clears the state legislature.

Two years ago, the Bay State passed a controversial law that prohibited pharmaceutical and medical-device companies from giving away meals and trinkets such as pens to healthcare professionals. Although the first-in-the-nation measure has been applauded for limiting undue industry influence over medical practice, many critics say the benefits do not outweigh the economic costs.

“Over the past year and a half, we’ve been hearing from device and biotech companies, the convention center and the restaurant industry, that this is causing additional problems during the worst recession in memory,” Representative Brian Dempsey, chairman of the Committee on Economic Development, told the Boston Business Journal.

The repeal is currently included in the State House’s economic development bill, but not in the recently passed State Senate version of the stimulus bill. Reconciling the two pieces of legislation may prove difficult as many State Senators strongly endorse the ban on gifts to physicians.

Notably, this is not the first time that gift bans have been challenged. Last year, after Johns Hopkins University in Baltimore, Maryland, and Partners HealthCare in Boston outlawed pharma handouts, James Thrall, radiologist-in-chief at Massachusetts General Hospital in Boston, told Nature Medicine: “Without robust interaction between practicing physicians and industry, no new technology will become available.” Read the full story in the July 2009 issue of the journal.