The name Janet Woodcock, M.D. is one that anyone who has followed the Heparin Catastrophe is familiar with. It was Dr. Woodcock who stood in front of Congress in 2008, trying to explain how the FDA could possibly have allowed the import of drugs into the United States from facilities that the FDA would not get around to inspecting for nearly 30 years.
It was clear in those hearings that the Congressmen and Dr. Woodcock were well acquainted, with many references to her previous testimony. It now appears that Dr. Woodcock was the pure Washington insider, well acquainted not only with those who were in charge of oversight of her job, but also with those who she was supposed to be regulating.
The Wall Street Journal reported last month that Dr. Woodcock has been accused of conflict of interest, not just on any old drug, but with a heparin based blood thinner, Lovenox. http://online.wsj.com/article/SB125003545637224263.html
According to the Wall Street Journal:
“The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.
“In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.”
It is an old cliché, but it may be time to throw out those bums. Change we can believe in must come to Washington. The debate over healthcare reform has shown just how deep the health industries ties are to our government. If we can’t return our government to the people, not corporate lobbyists, government for the people, by the people, may perish.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
FDA Use of Private Inspectors Raises Doubts
As if they had been reading this blog, the New York Times and the Rachel Maddow Show today blasted the FDA’s “chicken guarding the hen house” choice of inspectors. The FDA has allowed industries being inspected to be the ones who hired the FDA inspectors. For the Rachel Maddow video, see http://www.msnbc.msn.com/id/26315908/#29561173
The New York Times, at http://www.nytimes.com/2009/03/06/business/06food.html?_r=1 said:
“With government inspectors overwhelmed by the task of guarding the nation’s food supply, the job of monitoring food plants has in large part fallen to an army of private auditors like Mr. Hatfield. And the problems go well beyond peanuts.”
The total abrogation of its responsibility to regulate has left both of the FDA’s mandates – food and drugs – vulnerable. The NY Times article highlights peanuts and salmonella. The Heparin Catastrophe is the poster child for what is wrong with the FDA’s drug inspections. But the spirit of deregulation has harmed Americans in virtually all aspects of their lives.
One must ask, what was the SEC doing all those years, giving Bernie Madoff and Citibank, clean bills of health? What was the Justice Department doing worrying about Martha Steward and not Wall Street?
Ronald Reagan’s infamous quote: “government is not the solution to our problem; government is the problem” has left a legacy of a broken economic system, grossly disproportionate income distribution, corruption, and now, disease. We must allow government to go back to monitoring business. We must stop the absurd out cry outcry against a mild return to a progressive tax system. And we must use the Justice Department to prosecute crimes, not curry politic favor. For those who have been killed or made sick by Baxter’s greed, there must be justice.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
The New York Times, at http://www.nytimes.com/2009/03/06/business/06food.html?_r=1 said:
“With government inspectors overwhelmed by the task of guarding the nation’s food supply, the job of monitoring food plants has in large part fallen to an army of private auditors like Mr. Hatfield. And the problems go well beyond peanuts.”
The total abrogation of its responsibility to regulate has left both of the FDA’s mandates – food and drugs – vulnerable. The NY Times article highlights peanuts and salmonella. The Heparin Catastrophe is the poster child for what is wrong with the FDA’s drug inspections. But the spirit of deregulation has harmed Americans in virtually all aspects of their lives.
One must ask, what was the SEC doing all those years, giving Bernie Madoff and Citibank, clean bills of health? What was the Justice Department doing worrying about Martha Steward and not Wall Street?
Ronald Reagan’s infamous quote: “government is not the solution to our problem; government is the problem” has left a legacy of a broken economic system, grossly disproportionate income distribution, corruption, and now, disease. We must allow government to go back to monitoring business. We must stop the absurd out cry outcry against a mild return to a progressive tax system. And we must use the Justice Department to prosecute crimes, not curry politic favor. For those who have been killed or made sick by Baxter’s greed, there must be justice.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Heparin – Chinese Hogs versus American?
Greed. When a corporation gets caught with its pants down, it is always about Greed. Didn’t we just see this played out in great drama in the fictional movie, Michael Clayton? No one who saw the movie will ever forget its climatic ending with George Clooney entrapping Tilda Swinton on the back-fired greed of corruption and cover-up. Tilda Swinton won an Oscar for her portrayal of the last bastion of the unraveling conspiracy.
The unraveling of the Heparin conspiracy got a little clearer yesterday when the FDA announced that it is suspecting business fraud as the primary culprit behind the contamination of Baxter’s Heparin. Click here to see the story. The FDA’s theory is that somewhere in the China supply chain for the Heparin, some person or entity thought they could make a higher profit margin if they substituted counterfeit Heparin raw material, for the real thing. Woops if the substitute just happens to be toxic.
Assume the FDA is right. Should American drug companies be able to shift blame by finger-pointing at Chinese suppliers? Not in our book. A drug such as Heparin and its raw materials are ultra-hazardous substances, especially because they are to ultimately put right into the bloodstream of humans. And not just any humans, in the case of Heparin, very ill and vulnerable individuals. Who needs a toxin or hypotension (with resulting hypoxia) less than a kidney patient? See yesterday’s bog for a discussion of hypoxia.
Questions that must be answered:
We don’t yet know the specifics of the either the bean-counting that made the choice to go Chinese versus American on the pork. We may never know how that calculated profit was enhanced by a sophisticated counterfeiting process. What we can clearly presume, however, is that if Baxter had wanted to make sure that Heparin was pure, it could have used American pigs to produce it. The United States is the largest single exporter of pork in the world, trailing only the combined European Union for pork exports. While the Chinese produce more pork total than the U.S. its billion plus population consumes a much higher percentage than in other countries and they are actually fifth in exports.
So we know that since we are exporting pork from the U.S., Baxter could have bought it here. If they went overseas to get it, it must have been because pork bi-products had a lower value to them than to all than all those other American companies who make things from pork, such as pizza, bacon and countless bi-products.
Well, the safety and purity of things I put in my mouth is important to me. But a lot less so than the safety of what I put in my bloodstream. My mouth and stomach are made to filter out the contaminants, before the contaminants get into my blood stream. How could Baxter have valued the purity of their products less than those who make frozen pizza’s?
At some point we will learn that Baxter, by using Chinese pork, by some sort of bizarre bean-counter logic, saved up to 1 cent or maybe 5 cents a dose. But Baxter sold a lot of Heparin so the ultimate calculus was perhaps millions. Greed. For that incremental saving, we lost what will likely add up to hundreds of lives. We haven’t even remotely assessed the extent of permanently damaged human organs.
There exists a remedy in American jurisprudence for bean-counting gone haywire: it is called punitive damages. Usually it is reserved for the calculation to not fix a known defect. That application of punitive damages will likely apply here. But in this case we have more: we have homicide. Counterfeiting Heparin is murder by poison. Clear and simple. Only punishment, and severe punishment, can once again tell the corporate world that crime doesn’t pay.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
The unraveling of the Heparin conspiracy got a little clearer yesterday when the FDA announced that it is suspecting business fraud as the primary culprit behind the contamination of Baxter’s Heparin. Click here to see the story. The FDA’s theory is that somewhere in the China supply chain for the Heparin, some person or entity thought they could make a higher profit margin if they substituted counterfeit Heparin raw material, for the real thing. Woops if the substitute just happens to be toxic.
Assume the FDA is right. Should American drug companies be able to shift blame by finger-pointing at Chinese suppliers? Not in our book. A drug such as Heparin and its raw materials are ultra-hazardous substances, especially because they are to ultimately put right into the bloodstream of humans. And not just any humans, in the case of Heparin, very ill and vulnerable individuals. Who needs a toxin or hypotension (with resulting hypoxia) less than a kidney patient? See yesterday’s bog for a discussion of hypoxia.
Questions that must be answered:
- Why Chinese Pork?
- Is it just because they are more vulnerable that the kidney patients had the first reactions to contaminated Heparin that couldn’t be dismissed as something else?
We don’t yet know the specifics of the either the bean-counting that made the choice to go Chinese versus American on the pork. We may never know how that calculated profit was enhanced by a sophisticated counterfeiting process. What we can clearly presume, however, is that if Baxter had wanted to make sure that Heparin was pure, it could have used American pigs to produce it. The United States is the largest single exporter of pork in the world, trailing only the combined European Union for pork exports. While the Chinese produce more pork total than the U.S. its billion plus population consumes a much higher percentage than in other countries and they are actually fifth in exports.
So we know that since we are exporting pork from the U.S., Baxter could have bought it here. If they went overseas to get it, it must have been because pork bi-products had a lower value to them than to all than all those other American companies who make things from pork, such as pizza, bacon and countless bi-products.
Well, the safety and purity of things I put in my mouth is important to me. But a lot less so than the safety of what I put in my bloodstream. My mouth and stomach are made to filter out the contaminants, before the contaminants get into my blood stream. How could Baxter have valued the purity of their products less than those who make frozen pizza’s?
At some point we will learn that Baxter, by using Chinese pork, by some sort of bizarre bean-counter logic, saved up to 1 cent or maybe 5 cents a dose. But Baxter sold a lot of Heparin so the ultimate calculus was perhaps millions. Greed. For that incremental saving, we lost what will likely add up to hundreds of lives. We haven’t even remotely assessed the extent of permanently damaged human organs.
There exists a remedy in American jurisprudence for bean-counting gone haywire: it is called punitive damages. Usually it is reserved for the calculation to not fix a known defect. That application of punitive damages will likely apply here. But in this case we have more: we have homicide. Counterfeiting Heparin is murder by poison. Clear and simple. Only punishment, and severe punishment, can once again tell the corporate world that crime doesn’t pay.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney