Is this the end?
After more than two years of debate we finally have a decision on the fate of Avandia. According to a press release issued by GlaxoSmithKline (NYSE:GSK), “In the European Union*, the EMA has suspended the marketing authorization for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA have stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labeling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) program with additional measures to ensure the safe use of the medicine.”
With these decisions Diabetic Investor still sees little, if any, good coming from this situation. Just as hurricane Katrina forever changed the lives of the people in New Orleans, the Avandia controversy has created unimagined collateral damage in its wake. While New Orleans has slowly recovered from Katrina, reminders of this devastating natural disaster remain. The same is true with the Avandia controversy.
With these decisions now in place the FDA can move on and begin the laborious task of rebuilding their damaged reputation. There is no question the actions taken by the agency prolonged the controversy and heightened concerns that the agency is badly broken. It is also true that the drug approval process for diabetes medications has forever changed, yet no one knows if these changes will produce any true benefits. About all we know for certain is that the process will take longer and cost more money.
For their part GlaxoSmithKline is both a criminal and victim. In their zest for profits the company pressured respected researchers who raised legitimate concerns. Rather than allow a public airing of these concerns where they could be debated openly, the company unsuccessfully attempted to silence their critics. On the flip side, the company is also a victim of the Washington meat grinder, more commonly known as Congress. In their never ending quest to be seen as doing something, politicians do what they always do – hold public hearings so they can get their face time on television.
Never mind that these hearings actually did more harm than good, when it comes to being seen as doing something politicians care little about the damage they leave behind. It does not matter to them that they added gas to a blazing fire and made life a living hell for millions of patients and the physicians that treat them. And leave it to these public airbags to be the only people in Washington who could create sympathy for the members of the FDA. No matter how badly the FDA performed here, they did not deserve the public lynching they endured when they were dragged in front of the Senate committee.
What about Dr. Nissen and Dr. Graham, two of Avandia’s staunchest critics. While they have yet to publicly comment on these decisions, unusual given how much these doctors crave the media spotlight, will they look back and be proud of what they accomplished? While it’s possible they began their quest with the noblest of intentions, their actions left many, including Diabetic Investor, with the impression there one and only concern was being in the limelight. Given their previous actions Diabetic Investor suspects both will find fault with these decisions and demand more be done, exactly what is anyone’s guess but whatever it is we’re pretty sure they will find their way onto the television screen.
And what about the physicians who treat patients with type 2 diabetes, will they ever feel comfortable with the therapy recommendations they make. Will they ever be able to answer the question they hear from patients when prescribing medications – “Is this medication safe?” Can they trust what they are being told from the drug companies or will they forever be skeptical that the companies are withholding critical information? Treating patients with diabetes is not supposed to be like rolling the dice in Vegas where anything can happen and usually does. While they don’t need 100% certainty it sure would be more reassuring to know that the drugs they prescribe will at least do no harm.
For their part, drug companies must also be wondering what their lives will be like in the future. They already know from experience that dealing with the FDA is like watching the little white ball spin around a roulette wheel, wondering just where that ball will settle. They understand the drug approval process, already expensive and lengthy, has become even more expensive and will take even longer. They further understand that an approval is just the beginning of the process and that the FDA has list all perspective on adverse events. As Diabetic Investor has stated on several occasions there is no such thing as an adverse event free drug and that there is no realistic way to know what events may occur years after a drug is on the market.
Most importantly what are patients supposed to think? Here we are more than two years since this whole mess began and what facts do we really know? Studies have shown that therapy compliance, already a major problem, is worse not better. Drugs used to replace Avandia, i.e. Actos, once thought to be safe replacements are now under attack. It seems everywhere the patient’s turns there are more questions and no clear answers. Who can blame a patient for not taking their drugs, one thing they know for certain is that if they don’t take the drug it can’t harm them, even though their diabetes might get worse.
This is truly the sad part, as the many complications associated with poorly controlled diabetes can take years to develop. Even worse, the patient who decides to go their medications fearing the medication could harm them, does not feel any worse and falsely believes they should have never been on the drug in the first place. Diabetes is a slow and silent killer where therapy compliance is critical. Diabetic Investor has said it a thousand times if patients with diabetes experienced physical discomfort related directly to poorly controlled diabetes we would not see such dismal statistics on therapy compliance.
Perhaps the worst part of the decisions made today is this really isn’t an end. Rather this is the end of one chapter and the beginning of a new chapter in the diabetes drug novel. The troubles may be over for Avandia, but what will happen with Actos, as we noted earlier this drug once thought to be a safe replacement for Avandia is now under attack. Will the FDA now turn their attention to Actos? Will Dr. Nissen and Dr. Graham continue their crusade and seek the removal of all TZD’s from the market?
As Winston Churchill stated after the British victory at El Alamein in World War II, “Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”