Cut the ties of off-label use NOW

Sep/04/2008 02:58

When an industries are under scrutiny, such as pharma and medical devices, it's means that all interventions, whether patient or physician, have to go above and beyond guidelines. I was therefore extremely puzzled this morning to read an article on the front page of the Wall Street Journal about the off-label use of Medtronic's Infuse Bone Graft. According to the article "Medtronic says it abides by federal regulations that prohibit it from promoting Infuse for off-label purposes. But doctors paid by Medtronic are under no such restriction. They are free to discuss unapproved uses of the product. Surgeons can use the product as they see fit". The real question here is who benefits more from off-label use; patients, physicians or the company? Read More...

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The evidence gap

Sep/02/2008 07:20

There is nothing like a front page article in the Times to give the pharma business more headaches. The article in todays Times examines cholesterol drugs, namely Vytorin and Zetia. "Now some prominent cardiologists say that the evidence has swung so decisively against the drugs that they should not be sold. “The only place people should be taking it is in a clinical trial,” Dr. Allen J. Taylor of the Walter Reed Army Medical Center said of Zetia. (Vytorin is a single pill that combines Zetia with a statin, an older form of cholesterol-lowering medicine whose effectiveness and safety are not in question.)" Ouch... Read More...

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Science or lack of credibility hurting Byetta?

Aug/27/2008 05:50

Sensational headlines sell newspapers and a good story to run are the deaths associated with Byetta.

However if one reads beyond the headlines and digs into the story we find the following quote "In the four cases brought forward by the companies today, it’s not clear whether the patients were taking Byetta at the time of deaths. And the deaths are “not directly attributable to pancreatitis in any way”, Orville Kolterman, Amylin’s senior vice president of R&D said. For instance, one patient appeared to die from a relapse of leukemia two months after having pancreatitis. Also, patients with Type II diabetes have a greater risk of pancreatitis than healthy people to begin with, said Kolterman. So are consumers and physicians to believe the worst because of recent problems involving transparency or are they taking a "wait and see" precautionary attitude?

Read More...

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More troubles for Byetta?

Aug/18/2008 12:10

The news could not have come at a worse time for Lilly; “ New Byetta-Related Deaths Reported” is the headline in todays Wall Street Journal. However from one drugs woes comes opportunities and this could spell a major opportunity for Januvia. Not only is it an oral medication but now some patients may prefer Januvia or Byetta because of potential stronger warnings that may have to be included in the products label. Read More...

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Can Byetta extend life of Type 2 diabetics?

Aug/05/2008 08:16

Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer? Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference. In the trial, called Accord, patients with Type 2 diabetes were prescribed Byetta or any of several other diabetes medicines. Patients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug. This article from today’s New York Times is sure to get people talking again about Byetta but will it be enough to increase sales? Read More...

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Prescription drug abuse next on media radar screen?

Jun/29/2008 07:31

Prescription meds are the new drug of choice for rock and movie stars, some of whom have fallen prey to lethal doses. Hawthorne Heights guitarist Casey Calvert was felled late last year after mixing opiates with Vicodin, and Dark Knight star Heath Ledger overdosed in January from a deadly cocktail of oxycodone, hydrocodone, diazepam, temazepam, alprazolam and doxylamine. Eva Mendes reportedly entered rehab earlier this year for prescription drug abuse, and the new film Charlie Bartlett is about a kid who sells drugs at school to become popular. And he doesn't sell weed, coke or smack; he sells prescription pills. So will it be only a matter of time before the media and Congress start to blame drug companies and DTC for prescription drug abuse? Read More...

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Another Monday

Jun/23/2008 05:36

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. Read More...

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