Epilepsy

DNA patent threatens infant healthcare in Australia

Anne Zieger — Wed, 03 Dec 2008 10:55:51 -0500

In a sad sign of what can happen when companies get greedy, we have what may be the first example of private intellectual rights over human DNA hurting medical care.

Worse still, this case is affecting childrens' medical care, specifically children with epilepsy. A disabling condition called Dravet syndrome needs different treatment than epilepsy early in an infant's life, but the best way to diagnose it is to test for the SCN1A gene.

Unfortunately, Melbourne-based Genetic Technologies holds the patent for the gene, and has already threatened to stop public hospitals from testing for breast cancer gene mutations. As a result, public hospitals in Australia are afraid to test infants themselves and have to send blood samples to Scotland. And that process gets prohibitively expensive quickly, so many infants who don't fit the pattern of Dravet syndrome perfectly don't get tested.

Genetic Technologies claims that it might be willing to not prosecute for violations by public hospitals, but hasn't made any guarantees.

To learn more about this problem:
- read this Sydney Morning Herald piece

FDA panel votes against black box for epilepsy meds

Anne Zieger — Mon, 14 Jul 2008 12:02:19 -0400

For a long time now, it's looked like the FDA was gearing up toward putting a black-box warning on epilepsy drugs, since it was discovered that they can potentially increase the risk of suicidal thoughts and behaviors in patients who take them. However, in a surprise move, an FDA-convened panel has ruled 14-4 against imposing a black-box warning on this class of drugs, which includes Pfizer's Lyrica and Johnson & Johnson's Topamax. The committee concluded that though the risks were real, they weren't high enough to merit a black-box warning. And some panel members noted that imposing a black-box on epilepsy drugs might discourage some patients from taking them, even when the merits of the drug outweigh these risks. Instead of recommending the black-box warning, the panel is suggesting that the FDA send a medication guide to doctors outlining the drugs' risks.

To learn more about the FDA panel's decision:
- read this Wall Street Journal blog item

Related Articles:
Did Glaxo conceal Paxil users' risk of suicide?
Child suicide rise tied to FDA warnings

ALSO NOTED: Hospitals working to avoid needless ED care; FDA may soon require epilepsy drug labeling; and much more...

Thu, 12 Jun 2008 06:59:50 -0400

> Hoping to avoid further bad debt, hospitals are setting systems in place to avoid providing non-emergency ED care. FierceHealthFinance

> The FDA is close to a deal with drugmakers that would require warnings to be added to the the labeling on epilepsy drugs. FiercePharma

> The federal office of the National Coordinator for Health IT has released its five year plan, focused largely on patient-focused healthcare and population health. FierceHealthIT

> The University of California may end up taking over the vast task of reopening Martin Luther King Jr.-Harbor Hospital, which was shut down after years of problems and the loss of its CMS certification. Article

And Finally... This guy was determined to make it to court--no matter what. Article

Studies show problems with four big-name drugs

Tue, 29 Apr 2008 06:59:56 -0400

It looks like yet another set of popular drugs are facing allegations that they pose safety risks. Drugs named this week in unfavorable studies include Fosamax, which may create heart problems for women who take it for osteoporosis and epilepsy med Dilantin, which may put young women at higher risk of developing osteoporosis. Another study concludes that diabetes drugs Avandia and Actos double or triple the odds of non-spinal fractures, particularly among patients who took the drugs for a year or more. Particularly given other drug safety controversies still very much in the public eye, this can't be giving pharma marketers a warm and fuzzy feeling.

To find out more about the studies:
- read this FiercePharma item

Related Articles:
Merck expects $1.8B hit on Fosamax
Avandia problems erode GSK profits
Takeda touts Actos as heart attack-free
Despite safety issues, Vioxx still in demand