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?
According to a report this morning in the Wall Street Journal, "last week, the FDA said it had received reports of six new cases of pancreatitis – including two deaths – associated with the diabetes drug Byetta. Today, Amylin and Eli Lilly said that they had reported four additional deaths to the agency as well, which the FDA hasn’t yet made public." Yes this is alarming but there is a lot of information that is not made available so that physicians and patients can put the pieces of the puzzle together such as how many patients are currently taking Byetta? Physicians and patients, when deciding on treatment, can best determine if they want to try Byetta by the percentage of reported side effects. That being said, any side effect that included "death" can be devastating to a drug.
Now let's get the real business drivers here.. Analysts say the bigger picture issue is whether these safety concerns might affect the long-acting version of the medicine the companies are currently developing. The question “is whether the FDA, from a regulatory standpoint, will require longer term study of” the long-acting version, Barbara Ryan of Deutsche Bank said. “Rather than a short half-life, you’re going to have a longer term product. So if you get in trouble, it’s [in the body] for a longer period of time.” And Ms Ryan has what type of degree when it comes to drug development and science?
There are two bigger issues here:
1. Transparency: Will Lilly and Amylin be forthcoming with the data on reported cases of pancreatitis and death to both consumers, patients and physicians.
2. WIll the audience believe the data that Lilly and Amylin present or have the recent media stories about drugs led to a major credibility problem?
I could see a lot of physicians taking a wait and see position as Lilly and Amylin analyze and distribute the data and that surely cannot be a good thing right now given where Byetta is in its life cycle. Lilly could also benefit by monitoring the social media boards to determine what patients and prospects are saying about the drug and how they can best prepare DTC programs to answer consumers and patients concerns.
When Byetta first arrived on the market the New York Times ran a story of patient who has lost significant weight because of using Byetta. It was a great story and created a lot of buss but negative buzz can spread a hell of lot faster than positive buzz and this case unless Lilly and Amylin act fast Byetta could find the challenges created by the media and consumers too difficult to overcome.
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