Another Monday

Jun/23/2008 05:36 Filed in: Pharma Headlines
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Monday’s usually mean the start of another work week but for pharma the start of a work week can bring lots of headaches. Let’s see we have the Justice Department looking into the marketing and approval of Paxil, Lilly is waiting on word from the FDA on it’s competitor to Plavix (currently handicapped at 60% approval) and as more information comes out about the untimely death of Tim Russert many are asking the question “so even taking my cholerestol medication may not prevent heart disease?”. Yep just another Monday of challenges that pharma continues to be proactive about.


The death of Mr Russert has a lot of people with high cholesterol asking their doctors questions that they may not be able to answer without a lot more expensive tests. Mr Russert had high cholesterol and was watching his diet, taking medication and exercising but it is believed that some plaque within his arteries may have come lose causing his fatal heart attack. Now concerned, health conscience, patients are asking “how can I ensure that this doesn’t happen to me”? Mr Russert had just had a stress test and was, according to his doctor, doing OK. So the question then becomes is his death going to lead to new treatment and diagnostic guidelines that could cost a lot more money? Has anyone in pharma stepped forward to detail what happened to Mr Russert and inform patients so that they could have an educated conversation with their doctors?

Then there is the whole Paxil mess. Not only does it look like some documents might have been withheld but now the Justice Department is getting involved as the investigation widens. According to an article in the Wall Street Journal:

On June 14, 2007, two lawyers from the Los Angeles law firm Baum Hedlund met in Boston with Assistant U.S. Attorney Patrick Jasperse, a lawyer in the Office of Consumer Litigation, FBI agents and representatives from the Health and Human Services Department, at the Justice Department's request. The lawyers, George "Skip" Murgatroyd and Karen Barth Menzies, said in interviews that they were asked in detail about information they had collected for lawsuits about what Glaxo told the FDA about Paxil's potential risk of suicidal behavior, between 1989 and 1992, while the drug's approval was pending.

They were also asked if they had information about any activities by company representatives involving the promotion of Paxil's safety and efficacy for teens and children, they said.

"They [government officials] wanted to know about the research Glaxo did that said there were no suicidality problems, and what the data really showed," said Mr. Murgatroyd.

Yes let’s give pharmaceutical companies more leeway in making decisions as they always put patient health above profits.

Finally Lilly is waiting on an FDA decision for its competitor to Plavix. Could it be approved and if so what will the label look like and what REMS will be put in place? Right now the odds are 60% that the drug will be approved but the key is going to be what the final label looks like and what REMS will be put in place and how much this will effect the marketing of the drug.

All these new challenges that still point to one thing..the need for transparency and the clear need to put patients above profits. Who will win? It’s hard to say but unless pharma starts changing the way they do business pot holes like this are going to be everywhere for a long while.
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