By Jane Sarasohn-Kahn

It’s the drug that raised the profile of medicine in popular culture. It’s been hawked by a prominent politician and has been the butt of jokes on late-night TV. It’s Viagara, and it’s turning 10 today.

The FDA approved the drug on March 27, 1998. Here is the FDA’s approval page for it.

Pfizer’s Viagra reshaped pharmaceutical marketing in several ways. The company used direct-to-consumer advertising to great effect, and changed the game of DTC by advertising the drug not only in late at night broadcast outlets.

More broadly, the marketing of Viagra bolstered the trend of medicalization of everyday life. Viagra’s origin as sildenafil citrate was targeted to cardiovascular medicine. Originally conceived as a heart drug for hypertension and angina, the molecule was, serendipitously, found to be useful in erectile dysfunction.

In 1998, three scientists who studied the dynamics of nitric oxide, the secret sauce in Viagra, won the Nobel Prize.

Jane’s Hot Points: One of the most informative primers on Viagra is this book from Meika Loe of Colgate University. In it, she observes that we are Viagra nation where, "our sexual status quo has shifted dramatically." Ten years after Viagra’s entry on the health scene, the search remains for a "pink viagra," a version for women. No one can deny the game-changing role that Viagra has played in American health care and in popular culture.

Yesterday the THCB hit meter went off the charts. not sadly because of some new genius posting on THCB, but because the WSJ has this article about Lipitor causing memory loss and Google searches are bring up an article from 5 years ago on THCB that I wrote—after reading a piece in Smart Money about the same topic. Here was the key paragraph form that article

Unfortunately the Smart Money article doesn’t give any denominators, so there’s no real evidence other than these anecdotal stories about whether significant numbers of people have had these reactions to Lipitor.  So despite the heart-rending stories, you can’t draw any conclusions. Also don’t forget that in the grander scheme of things (if you believe the conventional wisdom that lower cholesterol reduces heart disease), Lipitor is saving thousands of lives for each one it hurts–if it does hurt.

The problem is that increasingly it’s become evident that the statin story is similar to other heart intervention stories—the endpoint which it helps (lower cholesterol in the case of statins, less heart blockage in the case of CABG and stents) doesn’t necessarily reduce overall mortality all that much on an absolute risk basis—and may have other damaging side-effects. Of course the most under-reported side effect from CABGs is also neurological deficiency. In fact there are serious clinicians who believe that use of statins or revascularization prior to a heart attack is clinically wrong.

So it appears that we know far too little about what’s going on before we really should be putting statins “in the water” as the cardiologists use to joke.

Then of course there’s the business interests involved. Pfizer has been roundly criticized for its Lipitor off-label marketing (even if going after Robert Jarvik for his lack of rowing skills is a little silly). But the pressures around a $12 billion franchise are likely to create this kind of behavior.

And worse. Peter Rost (not exactly Pfizer’s best buddy) has been pillorying Schering Plough for the stock trading behavior of its senior execs before recent belated release of data on the failed Zetia trial. And now Congress is joining in there too.

All of which gives me  pause to think about whether the whole statin era may be on its way out. It’s looked so obvious for so many years that more people should be on them, but maybe the pendulum of the perception of the evidence is starting to swing the other way.

And when you read a message board like this one at DailyStrength, it certainly gives this 44 year old with borderline high cholesterol pause before wanting to go down the statin path. Still I guess Feb 14 is an appropriate day to be confused about affairs of the heart!

Yup, they really are cashing in on the Placebo Effect.

In a story titled somewhat cryptically Medicare chief stands by anemia move (do they mean he’s trying to become anemic?) Reuters reports that CMS is not backing down from its decision to radically cut payments for anti-anemia drugs for chemotherapy patients. In English this means that Amgen’s Arenesp (& Epogen, though that’s not officially for cancer patients) and J&J’s Procit (which is Epogen re-marketed by J&J) are not going to recover their lost sales from last year.  Those sales began to be lost when studies revealed that the fairly rampant use of those drugs was overuse, and also that they were causing some severe side-effects.

Of course for reasons that we all know (e.g. they have little to do with clinical endpoints and more to do with financial ones), community oncologists have flipped out. I do like the response from Dr. Barry Straube, the chief medical officer at CMS. He said:

Our staff looked at over 800 evidenced-based articles published in the literature," he said. "I doubt seriously whether most clinicians read all 800."

Of course the real impact of this was not on patients per se, but on Amgen’s stock price, which has not had the best of years. The little rally late last year was on hopes that CMS would change its mind. I’m afraid that that gravy train looks like it’s over.

I’m sure (well I’m not sure but I’ll cheerfully and casually postulate) to keep you all amused on a Friday) that there are many possible overlooked problems with Lipitor and the statins. I’ve heard of severe muscle pain, even amnesia. But then again most cardiologists and the medical establishment recommend statins very widely and the general medical opinion is that they’re under-used.

I’m reading an interesting book The Last Well Person by Nortin Hadler whom I had the pleasure of meeting at the FIDMD meeting a few weeks back. Nortin is not exactly modest(!) but he’s very amusing and has firm firm opinions. In the book he systematically goes through the randomized clinical trial evidence of the value of much heart treatment including angioplasty, heart bypass, and statins. And his analysis from the West of Scotland trial (which admittedly was using Pravachol not Lipitor) is that statin use made only marginal absolute improvements in heart attacks and essentially no difference in overall mortality.

But is Congress investigating whether the medical establishment has been lead astray or is leading us astray? No.

Apparently the most important question is whether Robert Jarvik actually rowed his own boat in a Lipitor commercial….