Isn’t it always the way – the little fish get caught but somehow the big fish get away.
Key opinion leaders (KOLs) whose reputations are for sale can be relied on to say whatever a drug company tells them to, providing they are paid enough. The big fish I mean are ‘doctors’ such as Nemeroff and Keller in the USA and Montgomery in the UK. And the entire board of GlaxoSmithKline. Why no jail time for these people?
This is the way drug companies go about their business. They are happy to manipulate trial data to suit their own ends (while hiding the negative data) then they buy KOLs to talk up what can only be described as dangerous drugs.
Then they set aside billions of dollars in their accounts for the payment of fines and out of court settlements, and I, for one, am convinced they simply see this as just another part of the marketing cost of a new drug.
As long as the drug companies make more money than they pay out in fines (and they do, by a LONG way) then that’s good business – patients don’t come into the equation.
This story from Lawyers and Settlements:
GlaxoSmithKline is the subject of more bad publicity after a researcher was allegedly found to have falsified data in trials about Paxil. Meanwhile, the drug maker faces lawsuits alleging newborns suffered Paxil Birth defects when they were exposed to Paxil prior to birth.
The psychiatrist who reportedly falsified clinical data, Dr. Maria Carmen Palazzo, was a clinical investigator on studies conducted by SmithKline Beecham (doing business as GlaxoSmithKline). According to CNBC on 8/20/10, Palazzo has now pleaded guilty to 15 counts of failing to prepare and maintain records with the intent to defraud and mislead.
Palazzo reportedly included children in a study that involved diagnoses the children did not have. Prosecutors claimed that Palazzo also reported symptoms that her study subjects did not exhibit. She was sentenced to 13 months in prison, which she is serving at the same time as an 87-month term for healthcare fraud.
According to BNET (08/19/10), Palazzo was charged after the Federal Drug Administration (FDA) accused her of enrolling children in studies of obsessive-compulsive disorder and major depressive disorder even though the children she studied did not have the proper diagnosis for inclusion in the study.
Paxil now carries a black box warning about the risk of suicide in children. It also carries a warning about the risk of birth defects in babies exposed to the antidepressant prior to birth.
Lawsuits filed against GlaxoSmithKline allege the company did not adequately warn patients about the risk of birth defects, resulting in babies being born with serious health problems, including heart defects and persistent pulmonary hypertension of the newborn (PPHN).
GlaxoSmithKline reportedly settled a number of Paxil birth defect lawsuits, although the financial terms of the settlement were not disclosed. In announcing the settlement, the drug company said via e-mail that it “has reached agreement to settle certain cases involving the use of Paxil during pregnancy. The details of those settlements are confidential. Other cases remain pending.”
It is currently not known how many cases were settled, for what amounts or how many cases are pending. Bloomberg reported on 7/20/10 that Paxil agreed to pay more than $1 billion to settle more than 800 lawsuits that alleged Paxil was responsible for birth defects. Bloomberg further noted that the settlement works out to approximately $1.2 million to families and leaves around 100 lawsuits pending.
Remember, Glaxo has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.
Read more about Seroxat here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”
And what happens in the UK when the MHRA undertakes a criminal investigation into Glaxo and the withholding of clinical trial data?… and finds Glaxo guilty…?