My experiences with Chantix and my belief that it came to market too soon and significantly understudied inspired strong reactions last week in everyone who took the time to read and then write to me.
It's no news that information travels near the speed of light these days. Still, it was unsettling to wake up last Thursday morning, just two hours after this column was posted on the Internet, to find my inbox full of e-mails alternately praising or chastising me.
It was equally strange to realize that only a fraction of the mail was regional; the rest was from far-flung outposts around the country. I read through each and was at times puzzled, humored, disbelieving or grateful. One letter made me cry.
I almost wish I were an investigative reporter again in working this story. I would get to break out the trench coat, make lots of phone calls on someone else's dime and have resources in legal to call when I get nervous.
Not only will the story not go away, I suspect that what we know and what is available publicly is just the tip of the proverbial iceberg. The tobacco industry needed a whistleblower at some point, and perhaps the pharmaceutical companies do too. Granted, the basic ethics of tobacco companies and pharmaceutical companies differ greatly, but the bottom line is still big business.
Pfizer, for example, in 2006, had no fewer than nine medications with product sales of more than $1 billion each, and that amounted to just 64 percent of their pharmaceutical revenues that year. If you don't think there is a machine out there protecting that, and if that doesn't inform the analysis of all the information available in reporting this story, then it is probably good you are not the reporter in this particular dyad.
Chantix became available to consumers in August 2006, after receiving priority review from the FDA. These are granted in cases where there is evidence of a big public health benefit. It doesn't mean corners are cut, it means that more scientists and resources are put on moving a particular medication through established channels.
Pfizer showed the FDA the results in six clinical trials, which demonstrated an overwhelming benefit in a total of 3,569 chronic cigarette smokers. Only problem was, Pfizer excluded from those trials the very demography that makes up a relative majority of smokers in this country.
It is a well-established fact that about half the chronic smokers of tobacco in the United States have some form of mental illness. You can find scientific articles all the way back to 1990 with titles like "Blue mood, blackened lungs."
But it was an epidemiological study published in the Journal of the American Medical Association in 2000 that is cited again and again for its accuracy in design and analysis. Its conclusion? That "persons with mental illness are about twice as likely to smoke as other persons." Encouragingly, it goes on to say these persons also demonstrate substantial quit rates.
The chronic smokers who made it into the Pfizer studies for Chantix made the screening cut for mental illness. The 3,569 chronic smokers studied did not meet criteria for mental illness. If they did, they were eliminated. At least half the population for which this drug was being developed was not included in the studies that were important for bringing it to market.
Was this an oversight, do you think? The result is that real-world effects remained a big unknown when it came to Chantix, until it reached population at large.
A read of the transcript of the press conference by the FDA on Feb. 1 of this year begs an underlying story. The FDA representatives used words like "increasingly concerned" and "a number of compelling cases." They were diligent to point out that evidence is pointing more to exposure to the drug rather than other causes (read: baseline craziness).
For those who would be quick to argue that the Chantix nut bags are only made up of people with either diagnosed or undiagnosed mental illness, I say not so quick. There are also cases occurring in people without history of depressive illness.
Dr. Bob Rappaport, a director at the FDA, said at the press conference that "the concern is that there are many patients out there who are taking this drug who — for whom these kinds of serious outcomes could be prevented simply by being aware of the problem."
The woman in Florida who wrote the letter that made me cry would probably agree. Her husband was taking Chantix.
"Had suicide been listed (as a warning)," she wrote, "I have might have been listening more clear to what he was mentioning the three days prior to his death." He died by hanging himself from a tree in their front yard on Jan. 7, 2008. She put what she called his personality change down to the rigors of quitting.
"As much as I wanted him to quit smoking, it certainly wasn't worth his life."
Suzanne Danforth can be reached at suzanne.danforth@gmail.com.
