News of Interest

This morning's Los Angeles Times has two articles that may be of interest to the diabetes community. I have summarized the key elements here, but included references to the original articles for full details.

Big Pharma Spent Big Dollars Lobbying in 2006

The first article reported that the drug industry spent a whopping $155 million lobbying the federal government from 2005 to mid-2006, setting an all-time record that the industry might just top this year as Congress considers high-stakes legislation for the industry and consumers, a public interest group said in a report Monday. The industry's budget enabled drug makers to field about 1,100 agents to lobby congressional committees and administration offices in each of the last two years, the study said. As for the prediction about this year, as my readers may be aware, there is pending legislation which would enable "generic" (the FDA prefers the term "follow-on protein products") biopharmaceutical medicines such as insulin which the industry is fighting hard to make sure does not pass. The industry is also working to make sure the prohibition against Medicare negotiating drug prices for seniors in its prescription drug program remains intact, something Congress is looking into as the initial Bush Administration estimates proved to be significantly smaller than the actual cost of the Medicare drug benefit. The new Congress has also promised to re-visit the issue of permitting drugs to be imported from other countries like Canada, something else the industry has fought hard to prevent.

"Essentially what they [the pharmaceutical industry] did is blocked any legislation," said M. Asif Ismail, director of the center's project to monitor the drug industry. "There have been several attempts to revisit this issue, and importation is still illegal."

In addition to lobbying, the phamaceutical industry also spent more than $19 million on political contributions to candidates in last year's Congressional election, supporting mainly Republican candidates. However, the electorate grew unhappy with the way the war in Iraq was being managed by Republican leadership, enabling Democrats to seize control of both the Senate and the House of Representatives in the November election.

Finally, the industry also pays for the FDA in the form of user-fees. Legislation authorizing the FDA's user-fee system will expire this year unless Congress acts. Such must-pass legislation often attracts amendments. The pharmaceutical industry has agreed to hefty user-fee increases that would pay for new safety reviewers at FDA and help set up a computerized surveillance system to aid in detecting harmful side effects in new drugs. The hope is that by agreeing to these fees, they can persuade legislators that other legislation that the industry opposes would be an unncessary burden on the drug industry. That, at least, is the theory.

U.S. Patent Office Invalidates 3 Human Stem Cell Patents

A second article is reporting that U.S. Patent and Trademark Office has invalidated three broad patents for human embryonic stem cells that have been blamed for slowing research in the highly visible field of regenerative medicine. The rulings, from the U.S. Patent and Trademark Office, were preliminary — the patents are still enforceable in the interim, pending a final review in court.

The field of regenerative medicine is seen as a potential key to reversing type 1 diabetes once the issue of autoimmunity has been addressed. So far, the consensus seems to be that more will need to be done in order to return patients to insulin-independence because there is insufficient beta cell mass to free patients from the daily burden and risks associated with insulin replacement. Science hopes to be able to culture beta cells in vitro which could theoretically be transplanted back into patients whose bodies have destroyed these vital cells, and even better, the cultured beta cells could be customized to each patient.

The patent office ruled that the discovery of embryonic stem cells from primates — including humans — was not worthy of patent protection because scientists had already used similar methods to isolate embryonic stem cells from mice and other mammals, and described the cells' potential for producing medical therapies. The patent office issued its decisions Friday and released them to the public Monday.

The first of the three controversial patents was issued in 2001, three years after University of Wisconsin researcher James Thomson became the first to isolate stem cells from human embryos donated by fertility clinics. But as the field of stem cell research heated up, the Wisconsin Alumni Research Foundation, or WARF, gained a reputation for driving a hard bargain with universities and companies that wanted to use human embryonic stem cells.

The federal patent examiners cited patents and research papers going back to 1983 showing that stem cells harvested from mammalian embryos could be kept alive indefinitely while maintaining the ability to become heart muscle, nerve fiber or any other kind of cell. They noted that a 1992 patent involving mice stem cells described the potential for using the same techniques to create human embryonic stem cells.

"They [the U.S. Patent Office] rejected every one of the claims," said John Simpson, stem cell project director at the Foundation for Taxpayer and Consumer Rights in Santa Monica, one of the public interest groups that brought the challenge last year.

The patents have been a nagging problem for stem cell scientists, who have been worried about the costs and restrictions imposed by the patent holder, WARF. Some U.S. companies moved their research operations overseas, where the patents are not in force, after failing to strike a licensing deal with the Madison-based foundation, which manages the university's intellectual property.

After numerous complaints, WARF softened its requirements last year and reduced fees and legal requirements for academic researchers. But researchers still bristled at the idea that the cells, a natural product of human development, could be patented. On Monday, the U.S. Patent and Trade Office agreed.