Law under the Microscope

Jury Awards Blockbuster Damages in Vioxx Lawsuit

Last year saw the beginning of grumblings that drug companies may be keeping certain trial results out of the public, and that the FDA may also not be getting out cautions when needed.  Merck had been accused of hiding research that showed that its blockbuster arthritis drug, Vioxx, could cause heart problems.  One of the first liability suits filed against Merck just came out with the verdict - an award against Merck for $253 million to the widow of a marathon runner and Wal-Mart worker in Texas who blamed her husband's death on the drug.

There are many more lawsuits to come, but this was a fairly large blow (Merck is sure to appeal both the damages awarded and the liability issues).  I don't envy either the plaintiff or defense counsel. Many people who take Vioxx also had or potentially had other health problems, and it can be very difficult to prove the existence or absence of causation. Sounds like the plaintiff's lawyer here did a great job hitting an emotional vein with the jury (news reports don't really present much of the actual evidence, so no way of knowing how well he was also able to connect the dots to the husband's health status).

More later ...

Nanotech Cure for Cancer?

I'll be posting more later today on some regulatory/legal developments in the bioscience world, but wanted to pass along this article from Wired online. This could be a great development in treatment for various diseases - using nifty little nanoscale molecules that have tiny tendrils on them to administer vaccines and other medicines. Cheery news like this is always necessary to counter so much of the negative results and news we get inundated with these days.

Patent Backlog

One tidbit from the BIO 2005 sessions that really stuck in my mind - the PTO now faces a backlog of 500,000 patent applications. With the rate of growth in patent filings, they foresee having a backlog of a million applications within the next 10 years. The speaker, Dr. Jasemine Chambers, Director of Technology Center 1600 at the PTO, said that despite the increased filing fees, there has been little to no slowdown in the filings.

The PTO is hoping that some of the patent reform initiative and changes to restriction practice will help stem the tide and assist the PTO in digging out of the backlog and providing faster, quicker service for inventors out there.

BIO 2005 Conference

I'm now at the BIO 2005 Conference and will be posting a series of thoughts over the next few days about what has been discussed here. First, on a non-biotech-related note, I need to give a round of applause to the event planner who put on the reception on Sunday night. It was a fantastic party and all attendees seemed to thoroughly enjoy him/herself.

There have been a number of sessions devoted to the latest topics that bioscience companies face, and one of the better ones was last night that presented some of the more recently proposed legislative changes that could affect bioscience companies. One thing that would have added more value to the session would have been to include non-patent laws to the session and also to talk more about the affect that the proposed changes to the laws may have on bioscience companies. But it's easy to be a Tuesday-morning quarterback. I'll be adding more later on this ...

Merck v. Integra - Supreme Court Decision Seen as Victory for Research

It was like the shot heard 'round the world. No, not the Michael Jackson verdict.  The news that the Supereme Court had issued its opinion in the matter of Merck Pharmaceuticals v. Integra LifeSciences whipped through the bio world like wildfire.  The unanimous decision, written by Justice Scalia, is already being hailed as major support for clinical research that could usher in faster development times for the pharmaceutical companies.

The Court held that:

The use of patented compounds in preclinical studies is protected under Sec. 271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA.  The statutory text makes clear that Sec. 271(e)(1) provides a wide berth for the use of patented drugs in activities related to the regulatory process ... .

The Court was looking at what line could be drawn, if any, for when research would be considered experimentation that could go toward an FDA submission, and it surprised some by casting a fairly wide sweep.  The Court of Appeals below had rested its opinion on the finding that the Merck experiments were not explicitly designed for submission to the FDA, but to find the best drug candidate to test further. The Supreme Court acknowledged that basic research on a compound is not "reasonably related to the development and submission of information to the FDA." However, the exemption in 271(e)(1) for patent infringement does cover, the Court held, experimentation even if the drug does not become part of an FDA submission and use in experiments whose results are not submitted to the FDA.  Doing so would confound the purpose of experimentation.

The Court agreed with Merck's attorneys that a bright line could not be drawn at a clinical phase or type of research. Also, the Court took the government's amicus brief into serious consideration and noted that having all possible experiment results was what the FDA most wanted so it could evaluate the particular drug. Thus, there was no real limit on what could eventually be a part of an FDA submission.

The court did not opine as to how the patent infringement exemption affects "research tools,' as Integra did not argue that the compounds at hand were research tools and that the exemption might impinge upon them. That argument is left to another day and another lawsuit.

Crawford Still Under Fire

As a commenter to a past post noted, a dynamic physician with business savvy would be crucified at the FDA.  Alas, that commenter is likely correct. There are always people who will try to bring down someone who could bring necessary changes and enliven an institution.

But it might be that the current administration will not be able to rely on having its current non-dynamic physician appointed as the FDA Commissioner.  Some  Senators on the Health, Education, Labor and Pensions Committee, which will be considering the issue on Thursday, have made it very clear that they will be putting a "hold" on the nomination of Dr. Lester Crawford as the permanent FDA Commissioner (he has been the Acting Commissioner for 18 months or so now).

FDA, WHO Create More Web Sites to Help Decipher Drug and Vaccine Safety Information

More than one political pundit has deemed our current time as the Information Age. We're constantly inundated with data - some mundane, some crucial, much of it not-quite-so-accurate.

In the medical arena, omitting information or disseminating partial or inaccurate info can be annoying at best, fatal at worst.  In an effort to try to keep the public better informed about drug safety issues, the FDA is preparing to launch a new Drug Watch webpage. Likewise, to combat the myriad of websites that contain false or misleading information about vaccine safety, the World Health Organization (WHO) has created a list of 23 websites that it considers "reliable."

San Francisco to be Home for California's Stem Cell Research Institute

California made a big splash last year when it passed Prop. 71, which called for distributing $3,000,000,000 in bond-backed funds for stem cell research over the next 10 years. One of the first tasks the board that was chosen to run the California Institute for Regenerative Medicine had to face was picking a home. On Friday, San Francisco was officially announced as the future home for the Institute.

What I love about the NY Times article about the announcement is that it's incredibly brief, and notes that "[w]ith its international standing and spectacular views, San Francisco had been the early front-runner in an initial field of 10 cities that last week was narrowed to the four finalists."  As if the most urgent consideration in the process was which city was the most picturesque (having lived and traveled all over California, if that really was the criteria, they'd likely have chosen Santa Barbara, Napa or Tahoe instead).

FDA Still in Need of Leadership

The FDA has been without a permanent commissioner for about a year. It was exciting when, just a couple months ago, it looked like Dr. Lester Crawford would move up from being the Acting Commissioner to being the permanent Commissioner. Alas, his confirmation was blocked by two Senators and the FDA is still in limbo.

The reason for the blockage is rather substantial - Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) are concerned about the FDA's dragging its feet in making a decision about approval of OTC Plan B contraceptive. The contraceptive is strongly opposed by conservatives, but all scientific evidence states that it is safe and effective, so its prohibition from being on retail shelves appears to be entirely political.  As the FDA is supposed to be making decisions based on science rather than political winds, this is rather alarming.

NIH Still in Ethical Quandary

I have to imagine that there are some days where the director of NIH, Dr. Elias Zerhouni, just wants to run down the hallway with his fingers in his ears yelling "LA LA LA LA LA!"  In the last year, one of the stickiest issues the NIH has faced and that has gained huge public attention is the dilemma regarding outside compensation to NIH scientists by corporations.

To sum up the issue - until last year, NIH scientists were able to receive a certain amount of compensation  from outside corporations, so long as they disclosed that work. Then it came out that maybe two dozen of the thousands of NIH employees (researchers and non-researchers) had received rather hefty sums of money and it wasn't clear in each case whether those amounts were disclosed.  Following Congressional hearings on the issue, Dr. Zerhouni placed a moratorium on any scientists receiving outside compensation for their work.  In February, a new interim final rule was put in place that allows non-researchers to have up to $15,000 in stock holdings of pharmaceutical companies, and no NIH employee may perform any compensated speaking, editing or writing for a regulated entity or any uncompensated outside employment. In addition, no senior employee may receive any gift or award because of their NIH position that is more than $200 in value.

Oh, who knew how many problems this would bring to NIH ...