[nursebedlam]

GlaxoSmithKline sued over antidepressants
Reporter: Jayne-Maree Sedgman
TONY EASTLEY: The world's second largest drug company, GlaxoSmithKline, is being sued in the United States over claims it concealed negative information about one of its best-selling drugs.

The New York Attorney-General, Eliot Spitzer, who's brought the action, alleges the company hid studies that suggested the anti-depressant, Paxil, increased suicidal thoughts in some children prescribed the medication. The drug giant denies the claim.

Joe Baker is the Chief of the Health Care Bureau in the New York Attorney-General's office. He spoke to our reporter Jayne-Maree Sedgman.

JOE BAKER: Under New York state law, it is a fraud to conceal material information and our contention in this law suit is that when GlaxoSmithKline released positive studies about the use of Paxil in children for depression it also had negative studies, when it released positive studies.

And in order to provide doctors with all of the information that they need to make correct prescribing decisions, they needed to release all of the research and all of the information that they had in order for doctors to make the correct choice.

JAYNE-MAREE SEDGMAN: Is the allegation that they only released one of five studies carried out?

JOE BAKER: Yes, that's true. I mean, they released the one study that had mixed efficacy results and suppressed the other studies that had actually showed that Paxil was not better than placebo. And one even showed the placebo was better than Paxil.

And by not releasing those studies, doctors had none of that information in order to make a risk benefit analysis for each particular patient about whether the risk of suicide – because that is one of the side effects, it looks like, of the drug – was such that it was too much for the benefit that might be achieved by prescribing the drug.

JAYNE-MAREE SEDGMAN: Joe, how did you find out that these four other studies exist?

JOE BAKER: Well, we were… the studies were given by Glaxo to the FDA here in the US for another reason, for approval for the drug for obsessive-compulsive disorder in children and then they were also supplied to regulatory authorities in England, Canada and Ireland. So we knew that they existed and we asked for the studies, to take a look at them ourselves back in October, received them in March.

Once we had a chance to look at them and see what the results were, we knew that by releasing the one study they were basically misrepresenting Paxil's efficacy and safety, and so, you know, we developed our case.

JAYNE-MAREE SEDGMAN: Now, I understand that Paxil is not actually recommended for children, but it's sort of given, prescribed by doctors, "off the label" I think is the expression?

JOE BAKER: That's right and basically here in the US we have the Food and Drug Administration and they approve drugs for use for certain ailments in certain populations. Paxil is approved for the treatment of depression in adults, but not for the treatment of depression in children or adolescents. The only drug that's approved for that illness is Prozac in the US.

But Paxil… but doctors do have the ability to practice medicine by prescribing drugs for off label usage and indoing that, they use research and scholarly articles that are disseminated at times by pharmaceutical manufacturers and that's what happened here.

TONY EASTLEY: Joe Baker from the New York Attorney-General's Office, speaking to Jayne-Maree Sedgman.


http://www.abc.net.au/am/content/2004/s1122024.htm