GSK Reports – Now all we can do is wait for Monday

GSK Reports – Now all we can do is wait for Monday

This morning GlaxoSmithKline (NYSE:GSK) reported second quarter results and not unexpectedly Avandia was a major topic. While the company is publicly standing behind Avandia it’s difficult to imagine any scenario where the drug is cleared and sales return. The final nail in Avandia’s coffin could come Monday when an FDA panel meets to discuss Avandia.

Although the complete list of panel members and people who will testify won’t be available until Friday, battle lines are already being drawn. In the end all this attention could well end up as much to do about nothing. The fact is there are more questions than answers here. During Monday’s meeting each side will present their respective cases for and against Avandia. In the end the FDA will ask for a strong Black Box warning and it will all be over expect for the post-meeting analysis.

Avandia prescriptions have already fallen into the abyss and the addition of a strong Black Box warning will give those physicians who have been waiting for guidance all the evidence they need to convert those patients still on Avandia to another drug. The reality of the situation is there are alternatives which are as effective as Avandia that do not carry a Black Box warning.

Back at the ADA meeting this past June most physicians agreed that it would foolish to use Avandia with newly diagnosed patients. They further agreed that it’s a pretty easy to switch poorly controlled patients taking Avandia to another therapy. The most difficult decision facing physicians is what to do with patients taking Avandia who are well controlled. Do they continue to prescribe Avandia even with the warning or do they switch to another therapy option? This is not an easy decision as physicians are hesitant to change any therapy that is getting the job done. However, physicians also understand the legal risk they could face should a patient taking Avandia experience a heat attack or other adverse cardiovascular event.

Where the FDA panel may have an impact on this sub-set of well controlled patients taking Avandia is what if anything they do with Actos, another TZD. This is the most intriguing aspect of Monday’s meeting. While the meeting is focusing on Avandia its likely Actos will also be discussed. As GSK accurately pointed out today congestive heart failure is well known risk associated with TZD’s. Can the FDA issue a warning on Avandia and not Actos? Looking over all the available data Actos appears to be safer than Avandia but there have no long term studies that Diabetic Investor is aware of that have specifically targeted cardiovascular events as the primary endpoint. This places the FDA in a very uncomfortable position. As Diabetic Investor has previously reported Takeda who makes Actos has not raised their sales forecast for the drug, which could be a signal that the company is concerned that the FDA will require a Black Box warning for all TZD’s.

Should the FDA take the most conservative route and require a Black Box warning on both Avandia and Actos, this could change the competitive landscape for the huge type 2 market. Such a decision would create a conundrum for those physicians who after the news on Avandia came out immediately switched their patients to Actos. It’s interesting to note that shortly after the news on Avandia became public Actos sales spiked but have since leveled off. The worst possible scenario for physicians would be for the FDA to punt on Actos and not issue any guidance. Another nightmare scenario would be if the FDA issued a Black Box for Avandia and indicated more study was required to make a decision on Actos.

The one possible positive that could come out of this whole mess is a more frank discussion between physicians and their patients. Instead of just prescribing a particular medication out of habit, physicians could be forced to provide a more detailed explanation of all available treatment options. The reality of the situation is most patients’ do not understand or are not made aware of both the risks and benefits of the medications they are taking. All medications have side effects this fact is not in question. It’s also true that patients are not averse to taking medications that have side effects as long as they know in advance what those side effects are. Given the time constraints faced by physicians this type of discussion may well be unrealistic.

Given the realities of the situation it’s fairly easy to handicap the winners and the losers here. Diabetic Investor sees four major winners

1. Merck (NYSE:MRK) – Although Januvia may not be the most impressive drug we have yet to hear of any serious adverse events associated with the drug.

2. Amylin (NASDAQ:AMLN) – With its combination of solid control and progressive weight loss look for physicians to move more patients to Byetta.

3. Novo Nordisk (NYSE:NVO), Lilly (NYSE:LLY) and Sanofi-Aventis (NYSE:SNY) – The pro’s and con’s of insulin therapy are well known and more patient friendly delivery devices could help physicians overcome their resistance to prescribing an injectable therapy.

4. Becton Dickenson (NYSE:BDX) – The leader in syringes and needles will also benefit from the move towards injectable therapies such as Byetta and insulin.

While it’s obvious that GSK is a big loser here other unfortunate losers are the millions of patients with type 2 diabetes and the physicians who treat them. Patients and physicians need clear guidance when deciding on which treatment regimens to pursue. The FDA should provide this guidance but has failed to do so. Telling a patient to consult with their physician before doing anything is fine provided the physician has all the facts. In this case the evidence is unclear and confusing.

Diabetic Investor also sees the New England Journal of Medicine as a loser. This once respected publication has lost credibility with the way they handled the publication of the original meta-analysis. While Diabetic Investor agrees the drug approval process needs to be reformed there are other methods to get this point across. Leaking the meta-analysis to press, publishing a highly critical editorial along with the analysis leads one to believe the NEJM was pursuing an alternative agenda.

Finally and most unnoticed is what this situation has done to people like Dr. Nissen. Diabetic Investor sees nothing wrong with someone who based on their analysis sees a problem and brings this issue to the public’s attention. People can debate the merits of meta-analysis and Dr. Nissen’s motives however without people like Dr. Nissen what would happen to the flow of information. The Avandia situation is not the first time a researcher has come under attack from a drug company. Researchers and physicians have a moral obligation to bring concerns to the attention of the proper parties. Threats of legal action and personal attacks have no place here. We are dangerously close to the point where researchers and physicians are afraid to say anything negative about a drug for fear of attack or legal action. This is a slippery slop which could have disastrous consequences.

Prior to the controversy the Avandia franchise racked up over $3 billion in sales, an unqualified blockbuster. While Diabetic Investor does not believe GSK has intentionally misled the public or has done anything criminal, it is pure fantasy to believe that drug companies always put the interest of patients ahead of profits. Using their vast resources it would be a travesty if drug companies controlled the flow of information.

The free exchange of information is essential and should be protected at all cost. While Diabetic Investor sees little good coming from Monday’s FDA meeting at least the merits of Avandia will be debated in a public forum. Hopefully all the facts will be on the table so patients and physicians can make an informed decision on how to proceed. Diabetic Investor is not sure whether Avandia is a dangerous drug, what we do know is without the free flow of information this issue would never come to a resolution.

As the old saying goes “Don’t blame the messenger.” It’s the process that’s broken and in desperate need of change.

David Kliff
Diabetic Investor
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