The state of Indiana has apologized for its role in the eugenics movement. It's not the first state to do so, but this is particularly significant because Indiana was the first government in the world to endorse eugenic sterilization. A historical marker at the statehouse, unveiled in a ceremony yesterday, reads:

By late 1800s, Indiana authorities believed criminality, mental problems, and pauperism were hereditary. Various laws were enacted based on this belief. In 1907, Governor J. Frank Hanly approved first state eugenics law making sterilization mandatory for certain individuals in state custody. Sterilizations halted 1909 by Governor Thomas R. Marshall. Indiana Supreme Court ruled 1907 law unconstitutional 1921, citing denial of due process under Fourteenth Amendment. 1927 law reinstated sterilization, adding court appeals. Approximately 2,500 total in state custody were sterilized. Governor Otis R. Bowen approved repeal of all sterilization laws 1974; by 1977, related restrictive marriage laws repealed.

"Everyone has a price," goes the adage. Before last week, the FDA apparently thought this wasn't true for physicians, biomedical researchers, and others serving on advisory committees that give expert opinions on pending drug approvals. Last Wednesday, however, the FDA released draft guidelines to curb growing concerns that pharmaceutical companies may be greasing the wheels by giving advisory committee members exorbitant gifts and cash.

This is certainly an important first step to building confidence and integrity in the drug review process. But, what boggles the mind is why the FDA still thinks anything up to $50,000 is an appropriate amount for an advisory committee member to take and still give "impartial" advice. Put it this way: even under the revised rules, an advisory committee member could still take $49, 999.99 from Pfizer, Eli Lily, and other drug companies and then suggest that the FDA approve their drug applications the next day.

The Economist recently ran a special report on the etiquette of bribery, and a person more cynical than I might think that the guidelines laid out here are not unlike meeting a guy in a back alley with a stuffed brown envelope. And, evidence of committee members' substantial conflicts of interest in addition to their remarkably high 'yes' votes does little to dissuade this perception. Given the mounting evidence that, for example, doctors' behaviors can be skewed by gifts as small as a ballpoint pen or a ham sandwich, in what world is it ok to allow government advisors to take what Tony Soprano would call '50 large' before rendering decisions? How does it promote public health to allow public servants (albeit temporary ones) to take this kind of money from the private industries they are charged to regulate?

USPTO Building

The licensing arm of the University of Wisconsin has long been criticized for its patents in embryonic stem cell research. Researchers, companies, and public interest groups have all asserted that, by effectively covering all embryonic stem cell lines, the patents are stifling research and delaying potential treatments. Earlier this week, a federal agency agreed with these charges, and invalidated the patents.

After James Thompson of UW became the first scientist to isolate human embryonic stem cells in 1998, the Wisconsin Alumni Research Foundation obtained three patents that cover essentially all human stem cell research, and even the cells themselves. Last July, the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation, with support from stem cell researcher Jeanne Loring, requested that US Patent and Trademark Office review the patents. On Monday, the PTO sided with the advocacy groups in a preliminary ruling and invalidated the patents. Although WARF will pursue a lengthy appeals process (the patents do bring in millions of dollars, after all), Loring said that the decision will "remove one of the highest barriers to progress."

Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, said, "the PTO decision marks a welcome turning point in the battle against the unnecessary and unproductive privatization of mankind's quest to understand the natural universe." The next logical step would be to reexamine the wisdom of issuing patents on the human genome. Now's the time: A bill introduced this February in the House of Representatives would end future gene patenting.

Congratulations to Loring, FTCR, and the Public Patent Foundation on their victory.

After President Bush’s 2006 State of the Union, I wrote an op-ed for the San Francisco Chronicle that tried to contextualize what many thought to be his out-of-the-blue call for legislation to prohibit human–animal chimeras. When I wrote the piece, the reported proportion of human cells being injected into animal fetuses was relatively small (circa 0.1%), which led some to discount ethical objections to this research. Yet I did note:

Can this really comfort us? Is there any question that scientists may push the envelope as far as they can, from 0.1 percent to 1 percent to 10 percent? Why not 100 percent?

Sadly, it looks like this may have become true sooner than I thought. It was reported this week that Esmail Zanjani at the University of Nevada has created the first human-sheep chimera, with 15% human cells. That’s right: the decimal point is to the right of the five.

The biomedical rationale for this research is to create animals with organs that could be transplanted into humans. Given the significant number of people waiting for organ transplants, this is surely a laudable goal. Yet substantial ethical considerations still remain.

As these procedures advance and transplanting organs from chimeras to humans becomes more feasible, the proportion of human cells may come to rival the number of animal cells. And we currently don’t even have the language to think about these animals’ social and legal standing, let alone any public policies to govern this research or these organs’ use.

So now we face ethical questions about harvesting human body parts from partial as well as from full humans. How to assess this is a difficult question that deserves more thought than this blog post. What is clear, however, is that mutton lovers might want to eat up now. Their favorite dish may soon be regarded as a form of cannibalism.