Tuesday, May 27, 2008

Pilots and smoking

Federal regulators ruled that Pfizer’s smoking-cessation drug Chantix can't be used by pilots and air-traffic controllers. See more details at the Wall Street Journal Blog

Chantix has been under scrutiny for a while for psychiatric side effects. A report this week also suggested that the drug may be associated with physical problems including seizures. Pfizer has said such potential problems are rare, and are already noted on the drug’s label. More than five million people have taken Chantix in the U.S., Pfizer said.

Smoking and smoking cessation have a high association with depression and suicide - http://ije.oxfordjournals.org/cgi/content/abstract/32/6/1000. So, is it the Chantix or the cigarettes? Smoking is also the leading cause of heart disease, heart attacks and strokes - http://www.clevelandclinic.org/heartcenter/pub/guide/prevention/smoking/smoking_hrtds.htm
So, is it the cigarettes or the Chantix? Smokers also have increased risks of seizures and more dangerous consequences of their seizures - http://www.med.nyu.edu/cec/living/lifestyle/smoking.html. So, is it the cigarettes or the Chantix?

Clearly, for the vast majority of people, Chantix is a far better option and much lower risk than cigarettes. However, no drug is perfect, and no drug is for everyone. Glaxo has offered free Commit nicotine lozenges to pilots. That’s a reasonable alternative option for pilots and good PR for Glaxo, while Pfizer is taking a hit and until we get more data on Chantix.

Lets hope Altria-Philip Morris doesn’t take Glaxo’s lead and offer free Marlboros to pilots.

Robert Cykiert, M.D.

John McCain and Vytoringate

John McCain is now part of the Vytorin controversey, called Vytoringate by the media! He was apparently switched to generic statin (simvastatin) after the Vytorin study was presented at the American College of Cardiology meeting. See more details and discussion at Wall Street Journal Blog.

Looks like McCain’s doctors were as confused as most cardiologists, internists and family practitioners are about Vytorin, the ENHANCE study, and the American College of Cardiology expert panel’s recommendations. Poor communications with physicians and mixed signals from Merck and Schering-Plough resulted in much media hype, and now many physicians, including McCain’s, are confused about how to treat elevated cholesterol and LDL.

For two decades it’s been assumed that lowering cholesterol and LDL reduces the risk of heart attack and stroke. This has been documented with outcome studies for Mevacor, Lipitor, Zocor and other drugs. From the ENHANCE study we know Vytorin reduces lipids better than simvastatin alone. However, the ENHANCE study introduced a new controversey when it was shown that Vytorin does not reduce carotid artery plaque better than Zocor alone. Checking for reduction of carotid artery plaque using ultrasound was something that had not been done in previous studies, but somehow everyone expected to correlate reduction in lipids with reduction in artery plaque. Failure to show the correlation between reduction in artery plaque and cholesterol raised many questions about over 20 years of assumptions on the role of cholesterol and cholesterol lowering drugs (a multi-billion dollar industry).

Luckily, the ENHANCE study did NOT show that Vytorin is in any way harmful or worse than Zocor alone.

The simmering new scientific questions about heart disease and the role of cholesterol combined with suspicious behavior by two large pharmaceuticals has resulted in Vytoringate, a media feeding frenzy, and confusion by doctors who treat heart disease. The two pharmaceutical companies failed to communicate with their most important customers: the doctors who prescribe their medications! Needless to say, those doctors stopped prescribing on a large scale and sales dropped about 50% and billions of dollars of share holder equity for the two companies vanished almost overnight.

WhatDoctorsThink.com performed healthcare market research via an online physician survey of physicians who treat high cholesterol First in Jan 2008 and then in May 2008, and found that approximately 50% of doctors stopped prescribing Vytorin since the ENHANCE study and the media’s Vytoringate coverage. You can view the results of this public survey here. Note there is also an analysis of the two surveys as one of the links on that page.

So, I wonder what possible rationale could there be for MCain’s doctors to replace his Vytorin with simvastatin and allow his LDL cholesterol to rise from 83 on Vytorin to 123 without Vytorin?

Was it confusion? Risk aversion? You be the judge.

Robert Cykiert, M.D.