No Good Deed Goes Unpunished


in
No Good Deed Goes Unpunished
by Stephen Cervieri, Managing Director 
 
A leading AIDS med made by GlaxoSmithKline carries nearly double the risk of heart attack compared with other anti-HIV meds, according to a new study published by the Lancet. Abacavir - which recently was anointed a "preferred choice" for first-time AIDS treatment - stepped up heart attack risk by 90 percent, the 33,000-patient study showed. EU drug regulators asked GSK for more data on the drug so they might better analyze the potential risk.
 
AIDS treatment experts said that, because the study didn't identify a biological cause for the increased risk, they might not choose to switch patients off the med.
Plus, the patients most likely to develop heart problems with abacavir are those with underlying medical problems such as diabetes and high blood pressure - but the alternative drug can cause kidney problems in those patients.
 
GSK sped out a statement in response, saying that analysis of its own data on 9,600 patients show no increased risks (But the EMEA notes that these studies weren't designed to check for cardiac risks). Even if the heart attack risk were doubled, it would still be quite low, the company said: 6 per 1,000 patients versus 3 per 1,000.
 
Don’t Believe Everything You Read – Other than Lifelines Of Course.
 
A recent news item was a $65 million “Series A” funding for TriVascular2.
 
This is anything but a startup.  
 
It was a VC-backed company that Boston Scientific bought at a premium in 2005, but was shut down just one year later. This new funding is to buy the IP and capital equipment back from Boston Scientific, and to repopulate the company. 
 
Didn’t They Get Us Here in the First Place?
 
Just about everybody agrees that the FDA needs a safety overhaul - including Commissioner Andrew von Eschenbach.
 
The agency itself drafted a five-year plan that would channel user fees into more safety evaluators, epidemiologists, regulatory project managers, and risk experts, all to beef up post-marketing drug-safety oversight. In addition to new staff, the plan calls for technology and communications systems, plus two or three years of intense staff training.
 
Meanwhile, Rep. John Dingell has been working on a plan of his own. According to Congressional Quarterly, Dingell would expand the FDA's regulatory authority by funding a team of full-time overseas inspectors. He'd require drugs, devices, and food products to be labeled according to country of origin. He'd levy new user fees to pay for spot checks at overseas plants and U.S. ports. Sweeping change is absolutely necessary, Dingell tells us, and says that the agency doesn't have "the vaguest idea who's producing these things, whether they're safe or not, whether they're using good manufacturing practices or not...or anything else that might relate to seeing to it that the safety of the American people is attended to."
 
Ouch.