Law under the Microscope

Burrill Sees Upbeat 2005 in Biotech Business

Burrill and Co., one of the top investment companies in the biotech industry, has recently published its list  of what it sees to coming down the pipeline for life sciences in 2005.  In general, it predicts that more money will be invested in biotech research, and that more companies will start to make drugs that are targeted to narrow, specific conditions (as opposed to drugs that are blockbusters, hitting several symptoms/illnesses at once).  It also sees more challenges in the regulatory arena, with the FDA under fire and major pharma companies facing intense inquiry about the testing of their products.

I'm looking forward to seeing if its prediction that the BRIC countries (Brazil, Russia, India, China) really do make a big play for biotech this year, or if it may still take another 2 years or so before they cut off a big piece of the biotech pie.

Biotech's Future in 2005

We're closing in on the end of another year, so it's that time again - time for all prognosticators to rub their hands together with glee and try to predict what the coming year has in store for us. What's coming up in 2005 for the biotech industry? 

FDA Looks into Crestor Ads

The FDA is now looking into ads published for Crestor, a drug for patients with high cholesterol, and whether they claimed more than the drug can deliver. The story starts a couple weeks ago when FDA safety officer David Graham presented, in his testimony before Congress, a list of the top 5 worst drugs around (in his opinion), and Crestor was awarded the dubious honor. AstraZeneca responded by taking out a full page ad in the Washington Post that, in the opinion of the FDA, may have downplayed the side effects of the drug (potential liver damage or failure). The ad said that the concerns raised by the researcher had no scientific or medical basis. Egad. Unfortunately, while AstraZeneca can quibble about whether Dr. Graham overstated the concerns, the fact is that the FDA did issues concerns about the drug (approving it doesn't mean there are no concerns, after all). Just to sate your curiosity, the other four drugs cited by Dr. Graham were Serevent, Meridia and Bextra (for asthma,acne, obesity, and arthritis pain, respectively).

Be Aware for Pitfalls in Choosing Your Drug's Brand Name

Not only do pharmaceutical companies need to worry about whether their drug is safe and effective, they need to very carefully choose its brand name.  The article from the Boston Globe clearly sets out how drug companies can invest millions and millions of dollars in their research, only to have a drug's introduction to market stalled by the FDA's rejection of the planned brand name.

SUNY-Albany Awards Its First Nanotechnology Ph.D. Degrees

It looks like nanotechnology is moving further along in progress from a novel scientific idea to a more developed and accepted discipline. In addition to the U.S. Patent and Trademark Office  recently creating a new Class called "Nanotechnology" to help in searching for disclosures of technology, SUNY-Albany's College of Nanoscale Sciences has just awarded  its first Ph.D. degrees.

Chairman Named for Head of Stem Cell Research Board, part 2

The ICOC’s choice of Dr. Edward Penhoet, currently a Senior Director of the Gordon and Betty Moore Foundation, drew protests from concerned groups who worry about potential conflicts of interest from his years as the CEO of Chiron. Dr. Penhoet is also a former Dean of the School of Public Health at UC-Berkeley.

More generally, watchdog groups protested the meeting to elect the Chair and Vice-Chair because, they allege, the meeting violated open meeting laws by not allowing sufficient time for the public to have notice and consider the issues presented at the meeting for comment. The meeting was then postponed to a later date, except for the two votes. Further, the watchdog groups claim that too many of the ICOC members have industry ties that could create even more conflicts of interest when figuring out which companies and groups should get funding.

(many apologies - had a small glitch with the blog software, and had to divide the post into 2 pieces)

Chairman Named for Head of Stem Cell Research Board

In an earlier post, I wondered who would be named to the independent citizen’s oversight committee (ICOC) board that oversees the distribution of funds for California’s recently passed initiative to provide $300M each year for the next 10 years to companies to conduct stem cell research. Working under the gun, the ICOC of the California Institute of Regenerative Medicine elected Robert Klein, a real estate developer, as chairman of the board.

Controversy has already broken out because Mr. Klein was the only candidate on the ballot and he has no scientific background.

Leavitt Nominated to Head HHS

It’s been well-publicized that President Bush has nominated Michael Levitt, current EPA director, former Governor of Utah and former director of an insurance brokerage, as the head of Health and Human Services. Bush said about Mr. Levitt, "he has managed the EPA with skill and with a focus on results." Recently, a friend asked me what I thought about Mr. Levitt. What was his background? What could we expect from him?

Pfizer to Release Zoloft Research

In the past several months, we've seen a huge uptick in the amount of public concern about anti-depressant drugs, and an outcry from Congress and other watchdog groups to have pharma companies release their clinical trial results.  Pfizer Corp. has agreed to have some of that information released by the end of next year, on its website (or otherwise publicly accessible - details are presumably being worked out on that).

In an interesting twist, it also recently agreed to release information about one of its blockbuster drugs, Zoloft, in criminal matter. In the case, the defendant, 12 years old at the time of the crime, is accused of murdering his grandparents. His defense claims that the Zoloft, prescribed off-label, caused the boy to become psychotic and hear voices, which told him to kill his grandparents.

Cuba's Growing Bioscience Industry

Wired has an interesting piece on the burgeoning pharmaceutical industry in Cuba.  Who knew that so much money was being poured into drug development there? As the article points out, it's not clear where Cuba got the money from and how much it's put into the industry.