Law under the Microscope

Cure for the Common Cold

I wish this post was announcing a brilliant new cure for the common cold. After making it almost through an entire winter season in which each of my friends was hit at some point with some nasty virus or another, and after spending 9 days in a car on a roadtrip with my companion who contracted some whopper of a cold or related virus, I am now also needing Sudafed. Drat.

But this post is not about me. Per se. It's more to just throw an idea out there and see if anyone takes me up on it ...

Brazil Signs Biotech Safety Law

After months (ok, years) of struggling over whether and how to allow genetically modified crops to be planted in its land, Brazil has just signed a biotech safety law that will allow for such crops, with certain protections. Monsanto is a winner from this law, as it wants to plant more of its Roundup Ready soybeans there.  On Tuesday, Monsanto signed a royalty accord with soybean growers in the southern state of Rio Grande do Sul, one of the larger agriculture centers in Brazil.

With Brazil's national technical commission for biosafety (CTNBio) already having approved the introduction of Monsanto's anti-boll weevil cotton, Bollgard, a week before, it looks like Monsanto is taking no time to start research and production.  It might not be surprising that Monsanto's stock price has also increased by a couple percentage points over the last couple days (MON). 

Cancer Vaccine Companies May See Boost Soon

For the last few decades, scientists have been searching for cures to cancer. There are 5 companies now that, while not offering a cure, are offering what might be a safer therapy for different kinds of cancers - a cancer vaccine. These 5 companies are now in a race to see which one's Phase III clinical trial returns positive results first.

It's rather exciting news, and highlights just how tense a Phase III trial can be, especially when most of your predecessors in the theory have not been successful.

NIH Researchers Can Receive Consulting Fees, Cannot Hold Stock in Biomedical Companies

You may recall that the NIH had come under fire when it was revealed, after inquiry by former Rep. Greenwood, that some NIH researchers had received rather substantial consulting fees from biomedical companies that they had not disclosed. The NIH had reacted then by issuing a moratorium on all employees from receiving any funds at all from external sources for research until it issued it's final rule on financial arrangements between NIH researchers and biotechnology companies.

The NIH has finally issued its rule in an internal memo, and it's not quite as harsh as first proposed, but still has tighter restrictions than had been in place a year ago.  The new rule is that temporary researchers can retain their stock holdings in such companies, and permanent researchers must divest such holdings by October, 2005. There was no prohibition placed on receiving money or other compensation  from biotechnology companies.

India Contemplates New Drug Patent Laws

India has introduced the long-awaited legislation that will bring it more in line with the World Trade Organization rules about manufacturing generic versions of drugs. Right now, India only grants patents based on the manufacturing process and not on the resulting product itself. The proposed legislation would make the Indian government issue patents on all new products after developed after 1995.

The legislation worries a couple different groups of people...

E-Prescribing May Help Save Health Costs

In the last year or so, there has been a rabid flurry of attention being paid to health informatics and many proposals abounding on how using better technology and databases can reduce the rising costs of health care. Whether it's the National Health Information Infrastructure (NHII), e-clinical trials, or e-prescribing, they've all been touted as bringing about substantial savings for insurers, health care providers and employers. And done correctly, each of these programs (and the numerous others) each have the potential for changing the economics of health care.

But don't believe the hype ... just yet.

Grassley Issues Proposal for Independent Drug Safety Office

As expected, Sen. Charles Grassley (R-Iowa) is making rumblings about his soon-to-come bill to create an independent drug safety review office that will have increased capabilities for issuing warnings to drug manufacturers.  Several critics, including Sen. Grassley, have been going after the FDA for its internal structure that supposedly intimidates certain FDA scientists from waving red flags about approved drugs to their superiors, because those superiors have already approved the drug and the scientists fear retaliation.

I am really looking forward to seeing what his proposal is, for several reasons ...

Bloggies Handed Out

The 2005 Bloggies, the annual awards for blogs, were handed out at the SXSW Interactive Festival in Austin, TX.  Congratulations to all of the winners, including Wonkette (blogging with delicious gossip on politics and Washington), Boing Boing (blogging about all sorts of wonderful things) and Dooce (written by Heather Armstrong, one of the first people fired because of what she put on her blog about her employer).

Sigh ... sadly, there is no Blawg category. Some day, we shall have our little piece of the pie.

Monitoring Your Trademarks

Raise your hand if you have recently received an email touting "really cheap Via*gra" or similar variation lately. Is your company tired of having its trademarks and trade names misused and abused on the Internet, through spam or other unauthorized marketing? It's can be a big problem for pharmaceutical companies. While it should be pretty obvious that spam touting less expensive, misspelled drugs isn't from a particular drug maker, the public is clearly gullible and there are likely to be many people who somehow think they are getting the real drug either directly from the manufacturer or some distributor.

Luckily for Pfizer, Wyeth and other pharma companies concerned about whether their trademarks are being misused or infringed (also consider domain names that mimic or use their trademarks, "marketing" materials being used on suspect websites, etc.), there are a couple outfits that will help to track and alert companies about nefarious trademark hijackers. One such outfit is MarkMonitor. It has a couple terrific products that basically comb the web in a matter of seconds, and repeat the cycle every few minutes, to monitor the use (or, if you prefer, misuse) of its customers' trademarks. In the interest of disclosure, MarkMonitor is not a client of mine nor do I hold any financial interest in the company. I had the pleasure of meeting its CEO the other day, and was struck by the comprehensive products and services they offer in this area and by its client roster (the list here is a very abbreviated list - they work with several pharma companies, too). If you want a good weapon in your arsenal for the retention of the value of your trademarks, this is something your company may want to consider.

UN Backs Nonbinding Resolution to Ban Cloning

After a couple of years of debate on the issue and killing two competing proposals last fall regarding a stance on genetic cloning, the U.N. voted to adopt a nonbinding resolution that urges its members to enact legislation that would prohibit all human cloning. As may be guessed, each side is declaring victory. The US officially had been pushing for a binding resolution for all members states to ban human cloning, and the administration praised the final result saying,

"The United States and the international community have now spoken clearly that human cloning is an affront to human dignity."

Meanwhile, Britain had supported allowing each member state to decide for itself and also declared victory.

UK health secretary John Reid yesterday said that the UN declaration is "non-binding and will make no difference whatsoever to the position of stem cell research in the UK: therapeutic cloning will continue to be allowed. The UK remains 'open for business' in stem cell research."

One part of the declaration that kinda made me raise an eyebrow is, among its general language about protecting human life and prohibiting genetic research that is counter to human dignity, language calling on nations to "prevent the exploitation of women in the application of life sciences."  Now, I'm female. I'm against the exploitation of women. But sticking that among other language talking about the science research makes me wonder exactly what they're referring to (please pardon my ending this sentence in a preposition). If they mean they want to make sure women don't turn into baby machines a la The Handmaid's Tale, I'm in agreement. It just sounds weird to have it stuck in there (I mean, don't they also want to make sure there is no exploitation of men in the application of life sciences?). I'm waiting for the resolution to be published on the UN site to see what other discussion there is surrounding this part of the document.