Law under the Microscope

Nobel Prize Award in Physics and Medicine - Some Surprises

The winners of the 2004 Nobel Prizes in Physics and Physiology or Medicine were announced, with three researchers - David J. Gross, H. David Politzer, and Frank Wilczeck - taking the award for their work in physics and Richard Buck and Linda Axel winning the award for their work in physiology.

The physicists' work on their "unified theory of everything," studying the interaction of quark particles, garnered the honor. Their work is absolutely astounding, and really just makes the mind buzz with the notion of how the quarks' actions explain how everything acts and reacts.

The award to Drs. Buck and Axel was for their work in the science of how we smell things. Their work was truly revolutionary, shedding light on how humans smell. While, as the article notes, their research has not contributed to any drug development, it's only a matter of time before scientists and researchers find ways to incorporate the olfactory receptor mechanisms into drug research.

One of the more amusing aspects of this, IMHO, is how the Nobel Bourse missed the medicine award winners altogether (not to mention that there even is a Nobel Bourse). We humans will never stop gambling or pontificating on our own opinions, I suppose (including your humble blogger).

H-1B Visas Already Filled

This issue effects companies across all industries, but software and life sciences companies always seem particularly stung by the limit on H-1B visas that can be granted in the U.S. If anyone out there is just getting through their "to do" pile on their desk and came across the H-1B visa application for a needed employee, apparently you are too late. The fiscal year for visas began on Friday, and the nationwide limit on the visas is 65,000, "[b]y the end of the work day Friday, Citizenship and Immigration Services already had received enough applications to meet the limit."

There are some Senators working on a program that would provide an exemption to the number of visas granted to students who graduate from master and doctorate degree programs in the U.S. This proposal is not without controversy, though, as opponents claim that with the recent layoffs of so many in the technology industries, there is no shortage of needed workers. That likely depends, though, on who is being laid off - perhaps those particular skills are not as needed, but people with other skills are.

Of course, we could also try harder to improve the math and science programs in our schools and encourage more students to follow those paths, thus really making it more difficult for companies to argue that there are not enough skilled workers. But that's a rant for another day.

Agreement Protects Native Samoan Intellectual Property

For centuries we've seen the developed world usurp certain plants and knowledge from indigenous developing populations (corn, chocolate, aspirin). The affected populations typically have not seen any economic benefit themselves from whatever person or company starting using the plant in the first world countries, often are not later given real access to the drugs that are made with their plants or know-how, and sometimes have suffered harm from over-harvesting of the plant in their region (some populations, though, have seen some small economic payback through tourism to their land).

Recently, more and more companies have been hiring ethnobotanists to assist them in identifying plants that might have medical applications, but there had not been a rise in the benefits trickling back to the indigenous populations.

An agreement between University California at Berkeley and the island of Samoa may note a change in those winds, however. The agreement between Berkeley and Samoa relate to an AIDS drug, Prostratin, that derives from the genes of the mamala tree. In addition to receiving royalties from the sale of profits from the plant-derived form of the drug,

[a]ny proposed licensing agreement between the university and a pharmaceutical company using the Berkeley researchers' results to make the drug will require the company to make the drug available in the developing world either free, at cost, or at "very nominal profit," says Carol Mimura, director of Berkeley's technology licensing office.

With this as precedent, more groups and countries are likely to fight harder to see some remuneration from the plants they've tended and know-how they've gathered for generations.

Clinical Trial Subjects - Trading Insiders?

On Sept. 29th (yesterday), the Wall St. Journal had an interesting article on concerns being raised by subjects in clinical trials investing in the companies sponsoring the trials. The article can be found here, or on page D1 of yesterday's paper (unfortunately, the online version requires a subscription).

The article focuses on cancer patients, though that may be because it seems there are far more chat rooms, websites and other forums where cancer patients are sharing information about treatment (among other topics). At first blush, it doesn't seem like it would be that big a deal for subjects to invest in the company. They're also citizens, and who knows - maybe they believe in other products the company is producing (at least when talking about BigPharma and Biotech).

But going a bit deeper, it looks like in some cases, there may be cause for concern....

Continue reading "Clinical Trial Subjects - Trading Insiders?"

NIH May Ban Its Scientists from Consulting

In any clinical trial receiving NIH funds, principal investigators must certify that they do not have a financial conflict with the study (basically, that they do not have a financial stake in the outcome of the trial). It's always been viewed to be important to make sure that the research is not biased by the greed or need of the scientists (who, presumably, have the best opportunity to manipulate study data).

Now, NIH is proposing go another step further in making sure that conflicts do not enter into any research, and wants to ban its scientists from doing any outside consulting for one year (just to clarify, this is for scientists working directly for the NIH ... not scientists employed by private industry or academia, as that wouldn't make much sense). It seems that the NIH is being rather tight-lipped with details behind the call for the ban, but it feels that the review and approval process in place to allow its scientists to consult isn't as strict as it should be and the spokesperson for the NIH seems to imply that there may be some arrangements that could pose a problem.

Continue reading "NIH May Ban Its Scientists from Consulting"

Cloning Research May be Constitutionally Protected

While the exact issue of whether scientific research, including stem cell and cloning-related research, is absolutely protected by the U.S. Constitution has not been conclusively decided by the Supreme Court (or other judicial entity), there are certain scientists, ethicists and legal experts who believe that scientific research is subject to such protection. In the NY Times yesterday, there was a short article on how, while the current President's Council on Bioethics would prefer to keep the Constitutionality of certain policies out of the picture, they may face a stern challenge if one arose.

It seems that only a very few may claim that scientific research doesn't merit some Constitutional protection. What the protection of the 1st Amendment runs at odds with, though, are the funding restrictions often placed by the government (for instance, the current ban on federal funding of research with new stem cell lines). What is the line that will be drawn for when the restriction on funding becomes a de facto ban on that type of research in general? When does the Executive Branch's power to dictate funding options for scientific research become trumped by the 1st Amendment?

SEC Examining Biotech Companies

Recently, we've seen Eliot Spitzer, and then Congress breathing down the necks of biotech and pharma companies regarding the disclosure (or lack of disclosure) of their clinical trial results, and now the SEC is getting into the act. While this is not the first the time SEC has looked into potentially nefarious wrongdoings at biotech/pharma companies (for example, ImClone), it sounds like the SEC is taking a particular interest now with whether public companies are disclosing any negative clinical trial results on a timely basis.

It looks like at least the SEC's Boston office is scrutinizing the disclosure forms for regional companies:

Continue reading "SEC Examining Biotech Companies"

No Rate Hike for UK Stem Cell License

Earlier this year, scientists in the UK looking to get a license from the Human Fertilisation and Embryology Authority (HFEA) were concerned about a proposed rate hike of 3000% from 200 to 6000 pounds. Scientists throughout the country cried foul and noted that such a rate hike could stifle innovation and hamper their resources and budgets in research.

It looks like the rate hike won't be nearly so large, only 325% to 750 pounds for certain research.

Little Things Mean a Lot

As in little tax stimulus packages, little upgrades to the corporate laws of the state. Some Massachusetts life science companies say the new laws were just what they needed to be able to stay in the state.

Continue reading "Little Things Mean a Lot"

Proposition 71 in California for Stem Cell Research

There are a number of Propositions on the ballot for California (including mandatory employer-given health insurance), but Proposition 71 for the funding of stem cell research in California looks like it will be one of the most controversial. The Proposition would approve $3 BN (yes, three billion) in bonds for stem cell research and create a California Institute for Regenerative Medicine (human reproductive cloning would be prohibited). The total cost for this would be $6 BN, paid off over 30 years.

Supporters of the Proposition laud it as a huge boost to the California economy in the research and likely businesses it will create. Opponents claim that the $6 BN price tag is way too high for a state in financial crisis and also oppose stem cell research on ethical or religious grounds.