Disclosures about how some research has been conducted, by whom, and for what, continue to mount. In the last week, a trial, a research psychiatrist, and a journal fought for attention:
•Item 1: Documents from a lawsuit about AstraZeneca's antipsychotic drug, Seroquel, provided more evidence about the withholdng of unfavorable research - the kind that would affect how doctors and the public viewed the benefits of a particular medicine. If what the London-based drug company called "Study 15," sounds inconspicuous, something that wouldn't sound the alarms, it was meant to be.
Kaiser Daily Health Policy summarizes how the company cherry picked findings to make the new drug seem superior to older drugs while not disclosing information or AstraZeneca's own doctor's evaluation of the dangerous weight gain. Also hidden were the numbers of subjects who withdrew from the evaluation before it was completed.
Study 15 compared Seroquel to an older drug called Haldol and found that patients taking Seroquel gained an average of 11 pounds per year, that the drug was not more effective than Haldol in preventing psychotic relapses, and that 82% of the patients on Seroquel dropped out of the study before its completion.
Will Study 15 become slang and enter conversation as shorthand, like Deep Throat or Ponzi Scheme? Will we now say "it was a Study 15" to refer to deliberately hiding information unless a law suit or whistle blower shed light?
•Item 2: A New Jersey court will consider Harvard psychiatrist Dr. Joseph Biederman's request a request to seal information in a law-suit about off-label use of antipsychotic drugs to children. Biederman'a name has become linked to medicating children for bipolar disorder, and for receiving more than $1.5 million from drug companies. His lawyers say the information, including lectures he delivered, "could be immensely damaging to him, both personally and professionally." He is not a defendant in this case but the facts could well make him look bad. That could well be the case when a researcher violates the ethics underlying research, which is not skewing the outcome (even if there is a hunch). The <.em>New York Times reports how Biederman pitched studies. Other reasons it would not be useful to have the documents made public were addressed by the Wall Street Journal health blog:
Biederman had at least six violations of research protocol, according to an April 2004 letter from Massachusetts General Hospital's Human Research Committee, which is responsible for monitoring patient studies at the facility.
•Item 3: JAMA, the Journal of the American Medical Association, became embroiled in a controversy about disclosures of one of its authors. It started with a letter about conflict-of-interest by Dr. Jonathan Leo writing in the British Medical Journal and led to ugly words, allegations and the announcement of a new editorial policy by JAMA. But is this the end or just the beginning all over?
