The Utah Attorney General has filed a lawsuit charging GlaxoSmithKline illegally marketed its controversial Avandia diabetes pill as a new “wonder drug” that would reduce cardiovascular risks for diabetes, but instead increased the possibility of heart attacks. Consequently, the AG alleges Glaxo hoodwinked the state Medicaid program out of $7.8 million, which is the amount Utah spent to purchase Avandia between Jan. 1, 2001 and June 30, 2010 - a lost decade, of sorts.
“The state of Utah will continue to seek the most effective and safest treatment for its residents and expects pharmaceutical companies to fairly and accurately represent the safety and efficacy of their products," Utah AG Mark Shurtleff says in a statement. "If the pharmaceutical companies breach that trust, then we will come after them" (here is the lawsuit).
This development is hardly surprising. Numerous states have filed lawsuits against numerous drugmakers over the past few years - notably those selling antipsychotics - after safety issues were revealed about their meds. And recently, the US Department of Justice issued a subpoena to Glaxo and several state attorneys general issued Civil Investigative Demands over concerns the drugmaker failed to properly disclose clinical trial data and related marketing efforts (back story).
3 Comments
I imagine that GSK is having a pity party about now. With all the suits that include the payout to Cheryl Eckard, their Attorney Lauren Stevens being indicted for obstructing the FDA, and the Avandia payouts. GSK you brought this on yourselves and I hope the State of Utah wins. The people you should feel sorry for are the patients and study subjects who were harmed by using your products that are poorly researched and poorly manufactured so that you can save a penny to make a dollar.
The problems with Avandia could have been prevented and identified with ethically conducted, quality designed, and proper oversight of clinical research trials sites and data. What did GSK do - they designed trials that did not look at the cardiovascular issues. This was no mistake on their part because they must have suspected cardiovascular problems. As a former GSK Study Monitor with a short-term tenure in the Oncology division, I am sure their oversight of the investigational research centers to ensure the safety of subjects and the integrity of data was weak. I am sure any uncollected data in source records showing trends in cardiovascular issues were overlooked by the Study Monitors and the Clinical Research Division. GSK is like the 3 Monkeys, see no evil, here no evil, speak no evil. This means that everything is ok. Well it wasn't and the benefit of Avandia compared with the rate of harmful risks was downplayed.
State of Utah here is some advice. Request all Monitoring Reports from all of the Avandia clinical trials. Hire an expert like me who knows what information should be in those reports to review them. I bet you find a significant lack of information in those reports. I know that GSK makes Study Monitors re-word issues or remove issues from their reports. Their "unstated" policy is to have as little information in Monitoring Reports. This is quite different form their written SOPs. GSK report reviewers ensure that Monitoring Reports have no information in them that could possible delay the trial or be used in future suits. However, the absence of information in those Monitoring Reports for Avandia trials should be very telling and questioned by the State of Utah attorneys. One of your key items should be lack of adequate oversight of the Avandia clinical research trials as evidenced by the lack of information in the Monitoring Reports. So take them head-locked down to the mat as to why they did not follow their own SOPs when it came to "adequate" Monitoring for the Avandia trials because their reports will not be able to show adequate oversight.
GSK have your pity party - but you deserve to get sued for a lot more. I am waiting for the person that is stronger than me to sue you for Study Monitor abuse and non-compliance with the "intent" Federal Regulations regarding clinical research oversight. I know the FDA will not listen and neither would the Senator from my own state when I reported regulatory non-compliance from another company. After all, I am just a low level Study Monitor.
Here is the other sad fact. No matter how many times GSK is sued or fined they will not change. They will just continue to feel sorry for themselves that people are picking on Big Pharma without reason. They will enlist the help of PR specialists, highly paid attorneys, expensive lobbyists, their manufacturers association PhRMA, and the FDA to help them. Utah, I wish I could help you.
What else should be looked at are the diabetes drugs put out by Sanofi-Aventis. I know from first-hand experience they deliberately ignored the safety issues in their clinical research trials from 2000 to 2004. This included the non-diabetes drugs of Lovenox and Actonel. I am really surprised that nobody has yet to look at them. In fact it would not surprise me if Sanofi-Aventis was the original push behind getting the problems with Avandia out into the open. Removing Avandia from the market (as it should be until the true risks are known) leaves a void nicely filled by Sanofi-Aventis products or their new product being developed with CureDM for their human proislet peptide.
Go, Utah, Go Utah, Go Utah.
Go get 'em Utes GSK is extremely vulnerable right now. They have been demonstrating recntly that they hardly ever did the right thing.
GSK who makes THE deadly drug Avandia has conspired and is complicit in giving this drug to Disabled veterans once they get ill GSK hopes they will die before they resolve the claims.