Avandia Part Two?

Avandia Part Two?

It’s been years since Avandia was pulled off the market yet the diabetes drug market is still feeling the impact of the controversy created by our good friend that crusading cardiologist Dr. Steven Nissan. Yes the good doctor must be feeling pretty pumped up as once again another popular category of diabetes drugs is under attack. This time the hugely successful and very popular DPP4’s, the most notable of which is none other than the mega-blockbuster Januvia from Merck (NYSE:MRK).

Januvia spawned many copycats including Onglyza from AstraZeneca (NYSE:AZN), a drug which brought in almost a billion dollars last year. Well it seems that next Tuesday an FDA panel will examine whether Onglyza has a greater than acceptable level of risk. According to a report posted on the Fierce Pharma web site:

“The FDA is convening an advisory committee to consider data from the SAVOR outcomes trial, which suggested that Onglyza patients were more likely to be hospitalized with heart failure. In the 16,000-patient study, 27% more Onglyza patients ended up in the hospital with heart failure, compared with patients in the control arm.”

The folks at Merck are also conducting a similar study but the results won’t be released until June at the annual Scientific Sessions conference. Although Onglyza and Januvia are both DPP4’s they don’t work exactly the same so Merck may have nothing to worry about. However should the Merck study show similar results as the SAVOR trial, all bets are off. Keep in mind that the FDA is ultra-sensitive to cardiovascular issues even though in hindsight many believe Avandia got the shaft.

Right now the roulette wheel is spinning and no one knows where that little white ball will land. Should the FDA require a label change or perhaps Black Box warning for Onglyza sales of Januvia may rise.  On the flip side sales of other drugs such as Invokana from Janssen, a unit of Johnson and Johnson (NYSE:JNJ) may rise as physicians may take a wait and see approach with the Januvia data coming out.

We’ve said it before and well say it again we pay attention to the history of diabetes drugs as history is destine to repeat itself. For those who weren’t in this wacky world when the Avandia controversy broke let’s take a walk down memory lane. Unlike AstraZeneca, GlaxoSmithKline (NYSE:GSK) the makers of Avandia were ambushed when the data from Dr. Nissans notorious meta-analysis was leaked to the media and members of Congress. Congress then decided to conduct public hearings where our elected officials lambasted GSK and the FDA.

Yes we all know how politicians just love seeing themselves on television jabbering away in the hopes their constituents will believe they are actually doing something. And what better way to do this then by blasting away at the big bad pharmaceutical industry and the inept FDA.  Never mind that Dr. Nissans analysis had more holes than Boston has had snow this year or that several well respected researchers presented contrary points of view. Nope once the meta-analysis was leaked Avandia was guilty in the eyes of the public and it was just a matter of time before GSK had no choice but to pull the drug from the market.

Not surprisingly the FDA didn’t like being ripped a new one in front of a television audience and as always happens with a government agency they instituted new rules for how diabetes drugs would be approved in the future. Rules which required additional studies to examine a drugs impact on cardiovascular events. Rules which forever changed the diabetes drug market as these additional studies took time and cost tons of money.

So here we are yet again this time with DPP4’s in the hot seat. The question is will physicians not wait for the FDA to act and begin switching patients off DPP4’s now. Will they, as they did when the Avandia controversy broke, find alternatives even for patients that are doing perfectly fine using a DPP4? Will Merck be forced into the unwinnable positon of disproving a negative? Even if the Merck data shows no increase in risk physicians could easily reason better to be safe than sorry. One thing you can bet the kids college fund on is that no matter what the Merck data shows it will analyzed six ways from Sunday. One of the lasting lessons of the Avandia controversy is data is like statistics and as Mark Twain said, “There are lies, damn lies and then there are statistics.”

The ultimate irony here is that Januvia was a major beneficiary of the Avandia controversy as it was new to the market back then and appeared to be safe.   Even though the drug didn’t seem that great and many dubbed it Junknuvia, physicians embraced it as a replacement for Avandia.

Now Diabetic Investor does not mean to imply the FDA should not look into this situation. However as we learned with the Avandia controversy two respected researchers can look at the exact same set of data and come to two very different conclusions. That analyzing data is like looking at a piece of abstract art, one person sees something worth a million bucks and another sees a worthless piece of junk.

That the biggest loser here isn’t AstraZeneca or Merck, although they will be adversely impacted and not just losing sales but from the inevitable series of class action lawsuits that will come should the FDA come down hard on DPP4’s.  No the biggest losers just as it was during the Avandia controversy are physicians and patients with diabetes. Physicians who will be forced to make changes or risk being sued themselves and patients who just want a simple answer to a simple question; “Is the drug I’m taking safe?”

One of the worst aspects of the Avandia controversy was patients who could not get a simple answer to that simple question stopped taking their meds. Taking matters into their own hands it was patients who decided not to take a chance on any diabetes drug. Diabetic Investor remembers writing about this, predicting it would happen and was horrified when physicians confirmed that this prediction was coming true. Believe us when we say this is one time we did not want to be right.

It took years for many of these patients to be convinced to try something new, that there were new drugs on the market which didn’t carry the risk associated with Avandia. Ironically this new class of drugs is now coming under fire and history appears to be repeating itself.

The simple fact is what everyone wants is something they can’t have, drugs which are not just effective but free from ANY adverse events.  Sorry but this is NEVER going to happen no matter how hard pharmaceutical try or how many additional hoops the FDA makes these companies jump through. Diabetes is chronic condition and while some research looks promising there is no cure on the horizon. Managing diabetes is 24 hour a day 7 day a week 365 days a year job. Or put more simply getting patients to practice solid diabetes management is tough enough the last thing they need is to worry that the drugs they are taking could do more harm than good. Yet as bad as this may be its worse when their physician can’t provide a simple answer to what seems to be a simple question – “Is this drug safe?”

We hate to say it but here we go again.