The Week in Review

1. Sex bias in control of cancer pain. Women get less meds, more pain. Sounds like a Raw Deal.

2. AAAS comments on human subject protection training.

3. Gardasil requirement for immigrants stirs backlash.

4. Paxil suit settled by Glaxo for $40M.

5. Inspire Pharmaceuticals reaches deal with SEC in investigation related to clinical trial of experimental dry-eye treatment.

6. Chinese parents file tainted milk lawsuit.

7. Personalized medicine: new predictive tool can help determine treatment for breast cancer patients (identifies those most at risk of relapse, potentially avoiding chemo).

8. Doctors urge the FDA to ban OTC cough and cold medicines for children until they are found safe and effective. Not safe and effective? Perhaps we should resort to that cherry-flavored placebo elixir reported on in these very pages a few weeks back, eh?

9. Impact of expanded newborn screening in the US.

10. "Friendly" bacteria protect against Type 1 diabetes. Ah, friendly, protective bacteria. Such a nice change from those drug-resistant ne'er-do-wells.

11. Secrets revealed! Penicillin bug genome unraveled.

12. Scientists find gene pathway that triggers the spread of melanoma.

13. Researchers find yet another new source of multipotent stem cells—in the walls of blood vessels.

14. How best to schedule downtime for ERMs (Electronic Medical Record Systems) . *Is* there any good time for the records to be unavailable?

15. No more excuses! Health clubs gear programs for those with ailments.

16. Faster genetic test for flu virus approved in the US.

17. Genentech warns about PML (progressive multifocal leukoencephalopathy—a rare brain infection) death in a patient taking Raptiva for psoriasis.

18. European drug makers urge regulators to impose price controls. I know, this sounds counterintuitive, but you'll see, it's not (seriously).

19. NIH announces funding for new epigenomics initiative.

20. FDA grants 510(k) clearance to I-Flow for topical wound dressing that controls oxygen and moisture. I'd like to see this thing. How does it manage all that? I'm thinking of robo-bandage here.

AND in the category of "Weird News":

21. Tainted candy from China found in US: White Rabbit Creamy Candy. Yes, that's the actual name of the candy. Is it me, or does it sound oddly sinister? Or perhaps I read "Alice in Wonderland" one too many times as a kid. Darn, now I have Jefferson Airplane's song "Go Ask Alice" stuck in my head.

22. If bioterrorists strike, letter carriers might deliver antibiotics. Neither rain, nor snow, nor anthrax spore . . . Wait a minute, weren't these the guys who were targeted with the anthrax in the first place?

23. Experts call for warning labels on energy drinks. Apparently, these things are so chock full o' caffeine that they deliver quite a blast, and people aren't really aware of just how much caffeine they're loading up with. Gives me the shakes just thinking about it.

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

Angry Blogger vs Glaxo

An angry blogger in the UK, angry at drugmaker GSK over controversial cases of life & death side-effects (suicide) for depression sufferers resulting from the use of its drug Seroxat--the trade name in Britain for Paxil--posted this protest video in February.
From Pharmalot.com.

Closing the Loopholes for Big Pharma

Today's New York Times reports that about a third of the studies done on Paxil and Prozac went unpublished and (not surprisingly) if those studies were included these drugs were much less effective than when only the positive studies were published. http://www.nytimes.com/2008/01/17/health/17depress.html?
This is only the latest in a series of revelations about the way that pharmaceutical companies (“Big Pharma”) control the data about new drugs which they make available to the FDA in seeking approval and then to the public. No one disputes that these failures to disclose are harmful to the public’s health. Doctors prescribing drugs and using medical devices must have complete information in order to make the best treatment decisions. However, what is lost amidst the hand-wringing is that there is a very simple way to end this pattern and to make this information available to those who need it: require that all information, positive and negative, about drugs submitted for approval to the FDA be made available to a public data base. Current regulatory changes to require greater disclosure are inadequate because if there are any places left to hide negative data, Big Pharma will find a way to get there. Moreover, the arguments that it is somehow unfair to require companies to benefit from information about what doesn't work makes no sense because companies would only have to disclose AFTER they decide it is worth submitting the drug for approval.

Pharmaceutical companies are businesses like any other and are entitled to make a profit and to keep business information private—but only to the extent that it does not harm the public’s health. Having a drug approved for sale in the United States by the FDA is a privilege and it should come with the responsibility of making available all the available information—not just the information which the company chooses to disclose.

While it has always been the case that pharmaceutical companies were able to hide negative results in studies they conducted themselves, the need is much greater following a recent Supreme Court decision, Garcetti v. Cebalos, which held that government employees do not have First Amendment protection for divulging information—even information vital to the public’s safety-which they learn at work. Most people do not know that a growing number of research companies conducted by pharmaceutical companies are channeled through academic medical centers. While Garcetti v. Cebalos, did not involve research scientists it clearly suggests that a medical researcher at a state university which conducts drug trials for pharmaceutical companies could put his or her job at risk by divulging negative results. This silencing of whistleblowers means that without specific legislation that requires the disclosure of all data, wherever acquired, companies can continue to shield negative results from public view.

Of course is o.k. for pharmaceutical companies to make a profit, just as it is for auto companies, but when the product is one that can endanger the public’s health there must be a requirement of full disclosure.


Jennifer S. Bard, J.D., M.P.H.
Alvin R. Allison Professor of Law and Director, Health Law Program Texas Tech University School of Law Associate Professor (Adjunct) Texas Tech University School of Medicine
1802 Hartford Avenue
Lubbock, Texas 79409-0004
Jennifer.Bard@ttu.edu
806.742.3990, ext. 349


http://www.nytimes.com/2008/01/17/health/17depress.html?ex=1201237200&en=bff3cb16e49ff5f0&ei=5070&emc=eta1