GSK – Avandia Strategy – Blame the messenger or Lay low

GSK – Avandia Strategy – Blame the messenger or Lay low

This morning a report issued by Deutsche Bank indicated that initial proprietary daily prescription data from Impact Rx suggests that Avandia’s share of the newly prescribed oral anti-diabetic markets has dropped to around 0% from around 10% . Diabetic Investor views this report with a skeptical eye as it is based on just two days of prescription data. What we find more interesting is the strategy GlaxoSmithKline (NYSE:GSK) appears to be taking in regards to Avandia.

Whenever a widely prescribed medication comes under attack the company has basically two choices, fight back with their own data and army of experts or lay low while the situation sorts itself out. It appears Glaxo has decided to fight back and defend their multi-billion dollar Avandia franchise. Diabetic Investor sees this as a risky strategy as the company’s own studies found that Avandia increased the risk of heart attack by 30 percent.

While there is no correct method for dealing with a crisis this is one time when laying low may have been the better option. Should the FDA require a “black-box” warning for Avandia the company may have no choice but to pull the drug off the market, not unlike what happened to Rezulin. Instead of blaming the messenger or questioning the validity of meta-analysis, it would have been refreshing if the company had taken the patient’s side. While the company advised patient’s on Avandia to see their physicians they also stated “GSK strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.” The company has also posted an editorial that appeared in the Lancet called “Rosiglitazone: seeking a balanced perspective” The editorial basically states that there should not be a rush to judgment on Avandia.

Diabetic Investor sees several problems with this approach not the least of which being that it actually creates more confusion for the patient. As we have pointed out previously patients assume that once approved by the FDA their medication is safe and effective. But as we have seen with Rezulin and Vioxx, this perception is far from the reality of the situation. The truth is no one really knows the long term effects of any medication until it has been on the market for extended period of time and used by a wide audience. This is one reason metformin is so widely prescribed. On the market for nearly 50 years metformin has an established track record and physicians fully understand its risk reward profile. The heart attack risk associated with Avandia comes on top of news that using the drug can also increase the risk of bone fractures. Both problems have come to light after the drug had been on the market for nearly 7 years. Just how many adverse events need to appear before patients and their physicians realize a change is needed?

This brings up another problem, Avandia is not the only medication used to treat type 2 diabetes. A await and see approach is more understandable if Avandia was the only medication available or one of the more effective medications available, neither of which is the case. Besides metformin, Byetta and insulin are two drugs that can replace Avandia and actually produce better patient outcomes. Given that there are safe and effective alternatives a switch off Avandia is not a rush to judgment and could actually help the patient achieve better control.

You will notice that we did not include Actos as a replacement option for Avandia as both drugs are from the same class. There are some early reports from the field that physicians are simply switching their patients from Avandia to Actos, a risky move in our eyes. While there is no hard evidence that Actos also carries an increased risk of heart attacks, the jury is still out. In 2002, U.S. Food and Drug Administration staff scientists called for reports of congestive heart failure to be included on the label of Avandia as well as Actos. Some may recall that when the first reports came out that Avandia also was associated with bone fractures, Takeda who makes Actos said this did not appear to be a problem with Actos only to be proven wrong as latter reports indicated a similar problem with Actos.

Also missing from our list of potential replacements is Januvia. According to the most recent prescription data for the second straight week Januvia maintained new and total prescription share, accounting for 9.6% and 7.1% of market share. However there was a slight decrease in new prescription volume. After getting off to one the strongest launches ever for a type 2 drug, Januvia usage appears to be slowing. Billed as “an oral version of Byetta” by Merck (NYSE:MRK) sales reps physicians are finding the drugs performance rather disappointing. The fact that Januvia’s market share hasn’t grown for two straight weeks and new prescription volume decreasing points to further evidence of something Diabetic Investor has been saying since the drug came to market. There really is nothing special about Januvia and based on all available data one could easily conclude the drug is actually inferior to competing medications.

So just what should Glaxo be doing? Isn’t defending their drug and telling patients to seek the advice of their physician the prudent approach? After all when it’s all said and done it could turn out that the FDA does nothing and study data vindicates Avandia. Diabetic Investor considers this a highly unlikely scenario and history is not on Glaxo’s side. Using Rezulin and Vioxx as a guide we would say the odds are better than 70% that the FDA issues a “black-box” warning for both Avandia and Actos. It’s important to keep in mind that the FDA will not make this decision without Congressional pressure. The fact of the matter is the FDA is not immune to political pressure and when the study data is unclear it is safer to issue a “black-box” warning. The FDA can easily justify this move as there is enough evidence and as we have pointed out there are alternative medications available.

Given this scenario perhaps a better move for Glaxo would be to lay low and let the scenario play out. Instead of blaming the messenger and questioning the validity of meta-analysis, the company could have stated they believe in Avandia, they are confident the drug will be vindicated and that they will provide whatever data is requested. By questioning the validity of meta-analysis the company is opening a Pandora’s Box as they use the same type of analysis when it shows positive results for their drugs. It is disingenuous to question meta-analysis only when it produces negative results. We realize that when billions are at stake it is difficult to take a wait and see approach. This is especially difficult in today’s world of instant analysis and the 24 hour news cycle. However, in the long run this approach best serves the company. Should Avandia be vindicated the company can claim victory and get back to business as usual. Should the opposite occur and Avandia gets pulled from the market the company can state they cooperated fully with the investigation and accepts the outcome as it is in the best interest of patients.

To Diabetic Investor the company’s current strategy has produced a result the company surly does not want, it has kept the story in the news. Here we are over a week since the story broke and the story is still news. Even the tragedy at Virginia Tech did not dominate the news for more than a few days. The more the company steps up to Avandia’s defense the more reporters investigate. As the old saying goes; “It’s better to be thought a fool than to open one’s mouth and remove all doubt.”

David Kliff
Diabetic Investor
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