They looked at records of questionnaires taken and prescribing decisions made by a licensed, regulated online pharmacy called KwikMed — that is trying very hard to establish itself as ethically and legally different from those fly by night guys whose spam comments will rapidly attach to this post! They looked at the various outcomes and end points including safety and level of counseling and found that the online system produced results as good as or better as those found from a big records review in an unnamed (not surprisingly!) large multi-specialty clinic in Salt Lake City, UT.
Now obviously the ability to create an online questionnaire for specific conditions with clear inclusion/exclusion criteria (like ED or hair loss) means that as clear a picture can be gained in most cases from a good history taken online–and probably the history will be given more honestly by the patient. Plus the rigor of the history is probably better than one taken in a rushed office visit. And then it gets reviewed by a doctor who may recommend another approach but most times agrees and sends the Rx on to be filled.
Sean Neill is a South African-born, British-trained anesthesiologist, who
recently relocated to Midwestern USA. He blogs regularly at OnMedica about his cross-cultural experience, frequently pointing out oddities of American health care.
Watching television in America takes some getting used to. Apart from the accent, it is strange to hear companies marketing drugs directly to the consumer. Not only do they sell their own brand, but they actively name and shame their competitors’ products. During a commercial break there may be two different brands of antihistamine telling you how bad the other is.
Direct-to-consumer advertising (DTCA) is the promotion of prescription drugs through newspaper, magazine, television and internet marketing. Although the drug industry is mounting major campaigns to have DTCA allowed in Europe and Canada, the only two developed countries where it is currently legal are the U.S. and New Zealand.
Studies have shown that increases in DTCA have contributed to overall
increases in spending on both the advertised drug itself and on other
drugs that treat the same conditions. For example, one study of 64
drugs found a median increase in sales of $2.20 for every $1 spent on
DTCA. It has been reported that 10 of the leading 12 brand-name drugs
with DTCA campaigns have sales in excess of $1 billion annually.
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.
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.
They also have a very cool video called Paper Free health care (I spot some inspiration from the Health 2.0 video!)
I also got the chance to meet a much smaller company called SafeMed. Rich Nossfinger & Ahmed Ghouri hasve built a very very sophisticated rules and processing engine which can interpret drug data and embed that decision support into patient specific indications. Very intriguing stuff and you can learn more by listening to this interview (although they weren’t allowed to let me tell the world in advance that they are one of the first partners in the Google ecosystem. Here’s the SafeMed interview.
In 1937 marijuana was banned by Congress. The only question asked was, "what’s the position of the American Medical Association?". It actually was in favor of keeping marijuana legal for medical purposes. But the response given to Congress by whoever was pushing the bill (some diligent drug war historian will tell me who) was that the AMA wanted to ban it. And banned it was. And soon the AMA decided that it didn’t approve of medical marijuana–a position it holds to this day
60 years and billions of wasted dollars later, one major physician’s group has decided to change its mind. The American College of Physicians is now urging and easing of the ban on medical marijuana. We can only hope that the ridiculous ban on medical marijuana use, despite its therapeutic properties that exceed many FDA approved medications, are closer to being lifted with this type of support.
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!
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.
Just in case you needed to be reminded that the DEA is a refuge of evil scumbags and needs to be abolished, here’s another exhibit (from the good people at DRCNet):
Federal agents arrested Dr. Stephen Schneider, operator of the Schneider Medical Clinic, and his wife and business manager, Linda, on a 34-count indictment charging them with operating a "pill mill" at their clinic. The indictment charges that Schneider and his assistants "unlawfully" wrote prescriptions for narcotic pain relievers, that at least 56 of Schneiders’ patients died of drug overdoses between 2002 and 2007, and that Schneider and his assistants prescribed pain relievers "outside the course of usual medical practice and not for legitimate medical purpose."