Thursday, June 17, 2010

Maybe If Wyeth Had Paid Me $2000 Like They Did At Least One Doctor, I Would Tell You How Great Rapamune Is. Until I Get That Check Though, I'll Just Tell You How They're Accused Of Illegally Marketing It.

I've been accused, at times, of being a left-wing partisan. Of being a part of a vast media echo chamber whose mission is to parrot the talking points of the day handed down from our socialist overlords in order to meld the clay minds of the under-informed to secure the votes we need to implement the nightmare that would be a society more just and fair.

To which I would say this, would a member of a vast liberal plot to coordinate the thoughts of this country ever tell the Huffington Post they were dead wrong? Because that's exactly what I thought after I read this bit from a post there last month:

In a stunning whistleblower lawsuit, the world's largest pharmaceutical company is being sued over the dangerous practice of illegally promoting a kidney transplant drug for unapproved uses and targeting African-Americans, even though they are at high risk of complications.
...Sandler and Paris claim that Wyeth, which is now owned by Pfizer, promoted the "off-label" use of Rapamune, a kidney transplant drug which generated $376 million in sales in 2008, encouraging its sales force to promote the drug for heart, lung, liver, and pancreas transplants even though Rapamune was never approved for those procedures. The Food and Drug Administration warned against such off-label use of Rapamune in 2004 and 2007.

Um, excuse me Huffington Post, but maybe you can get your facts straight. Let's dig a little into the record, shall we?

A division of Pfizer Inc., the world's largest drugmaker, has agreed to plead guilty to two felonies and pay $430 million in penalties to settle charges that it fraudulently promoted the drug Neurontin for a string of unapproved uses.

And a little more:

As part of the record settlement, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing of its blockbuster atypical antipsychotic Geodon

And the hits just keep on a comin':

Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic Zyvox.

So I think by "stunning" what The Huffington Post may actually mean is "routine" My search for that famous liberal media bias I keep hearing so much about continues....

What is mildly surprising about this latest of the improper marketing lawsuits that seem to have a way of piling up at Pfizer's doorstep is the racial aspect. From the lawsuit:

In 2005, Wyeth’s sales management (headed by National Director of Transplant Sales Joe McCafferty) selected Philadelphia’s Einstein Medical Center as a center on which to focus a Wyeth marketing plan designed to rapidly increase or accelerate Rapamune sales in a 90 day period. Einstein’s transplant patient population was approximately 75% African-American in 2005.

Now from bnet.com

The suit claims that there is limited data on Rapamune use in black patients, who need a different dosing regimen than whites. Nonetheless, Wyeth targeted another hospital that primarily serves the black community for Rapamune “conversion.” Conversion is the practice of switching a patient from their existing transplant drugs to Rapamune. The FDA has only ever approved Rapamune for first-line use in kidney patients, and since 2004 the drug has carried a black box warning against conversion. Even Wyeth’s own internal studies did not show improved outcomes on Rapamune converted patients:

So, in 2004, a black-box warning was included in Rapamune's prescribing information against conversion. And in 2005, which is after 2004, Wyeth targets a hospital that serves primarily African-Americans to see if they can get some conversion happening.

I wish I could say that was stunning, but yeah, I'm sticking with mildly surprising.

"We prefer to think of it as an affirmative-action program" said Pfizer Chairman and CEO Jeffrey B. Kindler in an imaginary interview. "Actually more of a tribute to the many ways African-Americans have added to the mosaic that is America. Just as John Coltrane didn't follow the rules of music when composing his signature style of jazz, just as Martin Luther King did not always follow the rules of society as he led the struggle to defeat Jim Crow, we at Pfizer did not feel bound to follow the "rules" when striving to serve the African-Americans who are such an integral part of our experience as a nation."

Back to the real world now:

The suit describes a speakers list of 18 physicians who could talk about off-label use of drugs. One of those cited was the Cleveland Clinic's Dr. Stuart Flechner, who was available to speak about the use of Rapamune "for an honorarium of $2,000 or "prorated $15,000." Flechner, a fellow of the American College of Surgeons, was named one of the Top Doctors in America, according to the clinic's Website.
When doctors at Mt. Sinai Medical Center expressed concerns about using Rapamune as part of a specific regimen, Wyeth brought in Flechner to talk to them:
"Wyeth paid Dr. Flechner to assist in the marketing of the unapproved combination of Cellcept, an IL-2 receptor antagonist and Rapamune in order to overcome these objections and secure Rapamune sales."

I wonder how you spend blood money? Other than on some Ambien to help you sleep at night, I do wonder what you get when you sell your soul as people are struggling for their lives?

And I wonder when we're going to wake up. The corporations on Wall Street came within a whisker of destroying the world's economy with their little derivative games a couple years ago. The corporation with the warm and fuzzy green logo that says it's "Beyond Petroleum" is in the process of destroying this country's Gulf Coast with petroleum. And now, once again, the corporations that we entrust with our very lives seem to be comfortable with sacrificing a few of us in order to makes this quarter's sales goals.

And yet the more liberal among us still claimed to be stunned. The first step to a solution my friends, is to lose the surprise.

Wake...up.

8 comments:

harpy said...

but you're missing the point, Drugmonkey, the shareholders got a dividend. that is all that truly matters.

pillroller said...

man some people just don't get it. just ask doctor Mengele is you can buy a glass of water in hell for 2 grand

Anonymous said...

Right on my friend. You rock, as usual.

Anonymous said...

DM, I believe we can take away from your post the fact that drug companies cannot be trusted. We can take this one step farther and say that all corporations cannot be trusted. The corporations with power and money are driving America and they are driving it to ruin. The financial institutions on Wall Street with their wild derivatives just about brought down the whole financial system of the world. And, this story is not over. Greece is an example of a country where the derivative mess is still being played out. Our elected representatives in Washington have been bought and paid by the big corporations. The industrial military complex is keeping us at war so they can profit from all the weapons of war. The US has become the aggressor nation killing innocent individuals. A lot of people know that this country is on the wrong track. They are ignored. Pfizer is an example of a corporation without any "conscious". But, you have to think for a minute...no corporations have a "conscious". If they did, then you would not be working 12 and 14 hour days without a lunch break. There needs to be a mechanism for providing feedback to these corporations. Just as you and I cannot tell our chain corporation anything, the same applies to just about every corporation. There were probably a lot of people working for Pfizer that knew what the company was doing and did not like it. But, probably, like you and me, they could not do anything about it within the company. The lack of a mechanism to provide feedback to these corporations by their workers is not only harmful to the workers, but it is also harmful to the corporation. The corporations that don't pay any attention to their workers are the ones that eventually die.

Anonymous said...

Anon 7:40 PM: this accurate point of view, my friend, is the real danger of excessive greed by 'ruling class'. It was seen in several different 'civilized' societies within the past century, allowing an attitude of generalized discontent, unrest, and vulnerability ultimately to opportunistic dictatorship. The concept of forever vigilance against creeping socialism and communism is the red herring. The real culprit for laying the groundwork to incredible criminality in a society in a society is the dissatisfaction with inequities sometimes brought on by depressions or recessions and lack of provision for redress by the common man.

Mr Obama, our president, I believe, is attempting to provide leadership in bringing about a better sense of individual contribution, and general equity among the largest segment of the population, the middle class. His hands are tied at every turn--to protest against allowing corporations unlimited access to political elections, ensuring access by all to the natural resources in the future, etc. If there was any time in our recent history that needed more prayer (or something!) this is the time for reflection, discussion, and action in promoting the general welfare.

Anonymous said...

DM, what about McNeil and all the recalls? I have never seen anything like this in 40 years of pharmacy. Why is this not top news on the networks? Why is it taking so long for the products to be put back on the shelves?

Anonymous said...

I heard that there were numerous quality control issues at J&J, as well as general sloppiness and evasionary tactics such as an 'inside recall' (people paid to buy up all the product on shelves country-wide) to avoid the bad press of a FDA recall. Maybe, with the childrens' OTC cough & cold products recalled last year, FDA is looking to expand good-manufacturing GRASE restrictions and some of the products may not return to the shelves.

Anonymous said...

"I wish I could say that was stunning, but yeah, I'm sticking with mildly surprising."

How about easily anticipated and when oversight is paid for by those being watched, what do you expect? I love it when people say with great respect, "The FDA..." The FDA isn't a watchdog. How hard can you come down on the company that pays your salary?

To anon 7:42, "But, you have to think for a minute...no corporations have a "conscious"." Whaddya mean?
The Supreme Court just agreed that corporations are essentially PEOPLE with the right to free speech and therefore can spend gazillions to buy whatever they want from our elected representatives. I guess Pfizer is a Sociopath...whaddya think?