Showing posts with label corruption. Show all posts
Showing posts with label corruption. Show all posts
Tuesday, October 13, 2009
WARNING LABEL!!! Tort Reform Attached to Reform Bill
While Americans wait for a bill that will bring about health care reform, some in Congress are working to erode the rights of Americans.
Ted Kennedy’s good friend, Sen.Orrin Hatch, supports tort reform and wants to make it part of a health care bill.
"I think that this is an important step in the right direction and these numbers show that this problem deserves more than lip service from policy-makers." - CNN.com - Transcripts
A step in the right direction towards Hell, maybe. Perhaps the senator was referring to the number he got from the Insurance Industry. Here’s a letter sent to Hatch from Congress.Org.
Subject: Your $600,000 from the insurance industry.
To: Sen. Orrin Hatch
October 3, 2009
"I pledge allegiance to the insurance companies of America …"Following is a list of the money taken from the insurance lobby by United States senators (opensecrets.org). I stopped the list at $500,000. No-one gives this kind of money without expecting something in return, or takes it without the reasonable expectation of being asked to deliver.
(From the list):
Hatch, Orrin G (R-UT) $672,557
For the full list of payees see: - Congress.org - : Letter to Senator Orrin Hatch (R-Utah): Your $600,000 from the insurance industry.
Bend over America . You are about to get pricked by health care reform. Might we someday see warning labels on our medicine bottles:
“WARNING: The Attorney General has determined that if this medication is harmful to your health, you are S.O.L.”
Ted Kennedy’s good friend, Sen.Orrin Hatch, supports tort reform and wants to make it part of a health care bill.
"I think that this is an important step in the right direction and these numbers show that this problem deserves more than lip service from policy-makers." - CNN.com - Transcripts
A step in the right direction towards Hell, maybe. Perhaps the senator was referring to the number he got from the Insurance Industry. Here’s a letter sent to Hatch from Congress.Org.
Subject: Your $600,000 from the insurance industry.
To: Sen. Orrin Hatch
October 3, 2009
"I pledge allegiance to the insurance companies of America …"Following is a list of the money taken from the insurance lobby by United States senators (opensecrets.org). I stopped the list at $500,000. No-one gives this kind of money without expecting something in return, or takes it without the reasonable expectation of being asked to deliver.
(From the list):
Hatch, Orrin G (R-UT) $672,557
For the full list of payees see: - Congress.org - : Letter to Senator Orrin Hatch (R-Utah): Your $600,000 from the insurance industry.
Bend over America . You are about to get pricked by health care reform. Might we someday see warning labels on our medicine bottles:
“WARNING: The Attorney General has determined that if this medication is harmful to your health, you are S.O.L.”
Labels:
Congress,
corruption,
Health Care Reform,
Orrin Hatch
Monday, September 28, 2009
Enlighten the people…
On September 22, 2009, the Huffington Post featured a timely article by Anthony Tarricone, President of the American Association for Justice. In his piece, Mr. Tarricone warns about the “bargain” for tort reform being played out in Congress:
“As part of a ‘grand bargain’ to create a bipartisan health care bill, some have said tort reform should be included.”
Although some in Congress are attempting to include tort reform into the health bill, that inclusion would not be an enhancement for the American people; rather, it would be a disaster for civil rights, health and safety.
As Mr. Tarricone points out and, most certainly, Congress is aware:
- "98,000 people dead every year from preventable medical errors, at a cost of $29 billion. (Institute of Medicine).
- To put this into perspective, 98,000 deaths is like two 737s crashing every day for a whole year.
- Countless more are seriously injured with astronomical costs.
- The Congressional Budget Office and Government Accountability Office have looked at tort reform multiple times, and said it will save practically no money.
- They also found no evidence of so-called 'defensive medicine,' finding that doctors run more tests because of the fee-for-service structure, or because of the benefits extra tests have on patient care.
- Additionally, a 2006 study from Harvard found that 97% of cases were meritorious, totally debunking the idea that frivolous lawsuits plague our courts.
- And while 46 states have enacted some kind of tort reform, health care costs have continued to skyrocket, while injured patients or their families often can't seek justice."
So, why would a Congressional leader support tort reform, and why would they want it attached to the health bill? And, if it becomes so, will health reform end up sanctioning 98,000 deaths a year?
For the welfare of us all, we need to know where our elected officials stand on this issue.
Related: PharmaLittle: HOW HEALTH CARE REFORM SAVED FDA PREEMPTION,
http://pharmalittle.blogspot.com/2009/09/how-health-care-reform-saved-fda.html
Labels:
Congress,
corruption,
health reform,
Lobbyists,
Tort Reform
Wednesday, September 23, 2009
Eat, Drink & Be Merry…
Consumer Watchdog reports that Congressional members who sit on the five key committees charged with healthcare reform have, this year, been invited to 130 health industry fundraisers:
“The fundraisers included donations ranging from a low $500 to attend a ‘Healthcare Industry Reception’ for Rep. Mike Ross (D-AR) in July, a $1,500 Mexican dinner at La Loma with Sen. Mike Crapo (R-ID), to a $5,000 “PAC Gold Host” contribution for a breakfast event benefiting Sen. Tom Coburn (R-OK).”
Belgium waffles have really become expensive! Although, probably free for senators.
Over the same period of time health industry Political Action Committees (PACs) and individuals donated $30.7 million to committee members.
“$30M in Industry Money Clouding Debate, Says Consumer Watchdog.”
While the uninvited American taxpayer waits to learn the details of healthcare reform, members of Congress are being wined and dined by lobbyists.
“Who can tell which hard decisions on health reform are being made over $1,000 high-balls shared by lobbyists and politicians while the public’s locked out of the room?” - Carmen Balber, Washington Director for Consumer Watchdog
Per Consumer Watchdog, Sen. Max Baucus’ plan was under consideration yesterday by his committee. In it, all Americans would be required to have health insurance; however, there would be no cap on what insurance companies could charge. Furthermore, no public option is offered. Under such a plan, middle-class families might be paying almost 20% of their yearly income on health care.
“A mandate for individuals to purchase private health insurance with no affordable coverage alternative is exactly what the health care lobby hoped for from health reform.” – Consumer Watchdog
Here is something to think about:
“Lobbying disclosure filings for the first quarter of 2009 reveal that five of Baucus’ former staffers currently work for a total of twenty-seven different organizations that are either in the health care or insurance sector or have a noted interest in the outcome. The organizations represented include some of the top lobbying organizations in the health sector: Pharmaceutical Manufacturers and Researchers of America (PhRMA), America’s Health Insurance Plans (AHIP), Amgen, and GE Health Care.” See: - http://blog.sunlightfoundation.com/2009/06/22/the-max-baucus-health-care-lobbyist-complex/
The Baucus’ plan doesn’t sound like a plan for America. However, it would probably work for Max.
Full story: http://www.consumerwatchdog.org/patients/articles/?storyId=29608
Data analysis of fundraisers, campaign contributions and health care lobbyists:
http://www.consumerwatchdog.org/resources/healthcarefundraisers.xls
“The fundraisers included donations ranging from a low $500 to attend a ‘Healthcare Industry Reception’ for Rep. Mike Ross (D-AR) in July, a $1,500 Mexican dinner at La Loma with Sen. Mike Crapo (R-ID), to a $5,000 “PAC Gold Host” contribution for a breakfast event benefiting Sen. Tom Coburn (R-OK).”
Belgium waffles have really become expensive! Although, probably free for senators.
Over the same period of time health industry Political Action Committees (PACs) and individuals donated $30.7 million to committee members.
“$30M in Industry Money Clouding Debate, Says Consumer Watchdog.”
While the uninvited American taxpayer waits to learn the details of healthcare reform, members of Congress are being wined and dined by lobbyists.
“Who can tell which hard decisions on health reform are being made over $1,000 high-balls shared by lobbyists and politicians while the public’s locked out of the room?” - Carmen Balber, Washington Director for Consumer Watchdog
Per Consumer Watchdog, Sen. Max Baucus’ plan was under consideration yesterday by his committee. In it, all Americans would be required to have health insurance; however, there would be no cap on what insurance companies could charge. Furthermore, no public option is offered. Under such a plan, middle-class families might be paying almost 20% of their yearly income on health care.
“A mandate for individuals to purchase private health insurance with no affordable coverage alternative is exactly what the health care lobby hoped for from health reform.” – Consumer Watchdog
Here is something to think about:
“Lobbying disclosure filings for the first quarter of 2009 reveal that five of Baucus’ former staffers currently work for a total of twenty-seven different organizations that are either in the health care or insurance sector or have a noted interest in the outcome. The organizations represented include some of the top lobbying organizations in the health sector: Pharmaceutical Manufacturers and Researchers of America (PhRMA), America’s Health Insurance Plans (AHIP), Amgen, and GE Health Care.” See: - http://blog.sunlightfoundation.com/2009/06/22/the-max-baucus-health-care-lobbyist-complex/
The Baucus’ plan doesn’t sound like a plan for America. However, it would probably work for Max.
Full story: http://www.consumerwatchdog.org/patients/articles/?storyId=29608
Data analysis of fundraisers, campaign contributions and health care lobbyists:
http://www.consumerwatchdog.org/resources/healthcarefundraisers.xls
Labels:
corruption,
fundraisers,
Gang of Six,
health reform,
Max Baucus
Friday, September 4, 2009
The Eyes of Texas
A Reuters’ story tells about John Kopchinski, a Gulf War veteran from Texas who later became a disgruntled sales representative for Pfizer. John found Pfizer’s sales tactics hard to swallow. As he explains it:
"In the Army I was expected to protect people at all costs....At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”
Unable to live down to Pfizer’s ethics, he blew the whistle on ‘em.
Click link for full story.
"In the Army I was expected to protect people at all costs....At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”
Unable to live down to Pfizer’s ethics, he blew the whistle on ‘em.
Click link for full story.
Labels:
corruption,
Pfizer,
whistleblowers
Sunday, August 9, 2009
DIABETES CHARITABLE GROUP DUMPS MEDTRONIC
IPump.Org, Inc. Will Refuse Diabetic Supplies Made by Medtronic
In what could become an unprecedented kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.
IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.
IPump's statement on the matter can be accessed at:
http://www.ipump.org/blog/2009/08/08/why-we-are-no-longer-accepting-medtronic-insulin-pumps-and-pump-supplies/
There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.
The statement begins:
"Legal and Ethical Concerns Over Medtronic’s Business Practices
Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."
IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." It is also a tax write-off for individual donors of used devices and, until now, good PR for the company.
Quite extraordinary development, I think.
In what could become an unprecedented kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.
IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.
IPump's statement on the matter can be accessed at:
http://www.ipump.org/blog/2009/08/08/why-we-are-no-longer-accepting-medtronic-insulin-pumps-and-pump-supplies/
There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.
The statement begins:
"Legal and Ethical Concerns Over Medtronic’s Business Practices
Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."
IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." It is also a tax write-off for individual donors of used devices and, until now, good PR for the company.
Quite extraordinary development, I think.
Labels:
children,
corruption,
Diabetes,
FDA Preemption,
Medical Devices,
Medtronic,
Riegel
Thursday, August 6, 2009
FDA GOING ACTIVIST
Hamburg Outlines New Approach--Law Enforcement
The below, from todays WashPost, will be welcome news to most people here.
******************************************************************************
FDA Poised for More Aggressive Approach
By Lyndsey LaytonWashington Post Staff WriterThursday, August 6, 2009 4:05 PM
Margaret A. Hamburg, commissioner of the Food and Drug Administration, said Thursday that her agency will take a faster, more aggressive approach to enforcing regulations and laws.
"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible," Hamburg told the Food and Drug Law Institute in a noontime address.
Hamburg said she was making changes to FDA's internal processes to streamline and speed up the way it enforces regulations governing the safety of food, drugs and medical devices.
"In some cases, serious violations have gone unaddressed for far too long," Hamburg said. "These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising."
Hamburg, who has been on the job for eight weeks, said the FDA has often been hampered by lengthy internal debates and prolonged negotiations with violators, she said.
"Frankly, I can see in some past responses, there's a lot of back and forth, a lot of stall and delay, [the attitude of] 'let's wait and see what the company does,' " Hamburg said. "We need to be as clear as we possibly can about our expectations and standards, and when there are ongoing problems or when a problem emerges that has as serious impact on health, then we have to aggressively act."
For example, the FDA will no longer issue multiple warning letters to violators before taking enforcement action, Hamburg said. And if there is a "significant" threat to public health, the FDA might act before it even sends a formal warning letter, she said.
Hamburg said she thinks tough enforcement will act as a deterrent to companies who might otherwise violate the law. "Ultimately, the FDA's success should be measured not by the number of warning letters or injunctions or seizures but by our impact on the health and welfare of the public. Enforcement of the law is not simply an end in itself -- enforcement is critical to the agency's public health mission."
The below, from todays WashPost, will be welcome news to most people here.
******************************************************************************
FDA Poised for More Aggressive Approach
By Lyndsey LaytonWashington Post Staff WriterThursday, August 6, 2009 4:05 PM
Margaret A. Hamburg, commissioner of the Food and Drug Administration, said Thursday that her agency will take a faster, more aggressive approach to enforcing regulations and laws.
"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible," Hamburg told the Food and Drug Law Institute in a noontime address.
Hamburg said she was making changes to FDA's internal processes to streamline and speed up the way it enforces regulations governing the safety of food, drugs and medical devices.
"In some cases, serious violations have gone unaddressed for far too long," Hamburg said. "These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising."
Hamburg, who has been on the job for eight weeks, said the FDA has often been hampered by lengthy internal debates and prolonged negotiations with violators, she said.
"Frankly, I can see in some past responses, there's a lot of back and forth, a lot of stall and delay, [the attitude of] 'let's wait and see what the company does,' " Hamburg said. "We need to be as clear as we possibly can about our expectations and standards, and when there are ongoing problems or when a problem emerges that has as serious impact on health, then we have to aggressively act."
For example, the FDA will no longer issue multiple warning letters to violators before taking enforcement action, Hamburg said. And if there is a "significant" threat to public health, the FDA might act before it even sends a formal warning letter, she said.
Hamburg said she thinks tough enforcement will act as a deterrent to companies who might otherwise violate the law. "Ultimately, the FDA's success should be measured not by the number of warning letters or injunctions or seizures but by our impact on the health and welfare of the public. Enforcement of the law is not simply an end in itself -- enforcement is critical to the agency's public health mission."
Labels:
corruption,
FDA,
Hamburg,
Law
Monday, April 6, 2009
FDA Scientists Petition President Obama - Protect the Public, Protect the Whistleblowers
DEAR MR. PRESIDENT - PLEASE CLEAN UP THE FDA NOW.
The attached letter from FDA Whistle blowers to President Obama petitions the president to act now to clean up the corruption in the FDA.
I applaud these anonymous heroes as they put their professions on the line in the face of blatant threats from their management for no reason other than our safety and protection.
May you succeed in your valiant endeavor.
Dear Mr. President
The attached letter from FDA Whistle blowers to President Obama petitions the president to act now to clean up the corruption in the FDA.
I applaud these anonymous heroes as they put their professions on the line in the face of blatant threats from their management for no reason other than our safety and protection.
May you succeed in your valiant endeavor.
Dear Mr. President
Labels:
corruption,
FDA,
letter,
Obama,
Whistle Blower
Saturday, March 14, 2009
It Ain’t Necessarily So…
The Boston Globe has reported that an anesthesiologist at Baystate Medical Center in Springfield, Mass. allegedly fabricated studies on post-surgery pain management.
“The investigation uncovered 21 published papers over 13 years…”
Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia, stated that, if the allegations are proven to be true, the case will be “the largest research fraud in anesthesia.”
Some of the drugs involved, Celebrex, Lyrica, and Neurontin, are made by Pfizer and it was learned that the company had given the doctor five research grants, and he was also one of their registered speakers. However, a Pfizer spokesperson stated that the company is, “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”
The doctor is currently on leave.
To read the full story, copy and paste the link below.
www.boston.com/news/health/articles/2009/03/11/doctor_accused_of_faking_studies/ - Liz Kowalczyk, Globe Staff / March 11, 2009
“The investigation uncovered 21 published papers over 13 years…”
Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia, stated that, if the allegations are proven to be true, the case will be “the largest research fraud in anesthesia.”
Some of the drugs involved, Celebrex, Lyrica, and Neurontin, are made by Pfizer and it was learned that the company had given the doctor five research grants, and he was also one of their registered speakers. However, a Pfizer spokesperson stated that the company is, “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”
The doctor is currently on leave.
To read the full story, copy and paste the link below.
www.boston.com/news/health/articles/2009/03/11/doctor_accused_of_faking_studies/ - Liz Kowalczyk, Globe Staff / March 11, 2009
Labels:
corruption,
doctor gifts,
Pfizer
Friday, February 27, 2009
AstraZeneca, Seroquel, and Trading Ethical "Distinction"
Seroquel and the Process of Corruption
As many here will know, there have been a number of stories today about Astra Zeneca's alleged cover-up of studies indicating the diabetes risks of Seroquel. The Wall Street Journal Stories have been particularly informative. Here is a brief snippet (which will remind some of you of our peanut thread--truth is sometimes a lot like fiction):
"In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a "weight and diabetes sell sheet" they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug.
"Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile," Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to "refocus the call" away from diabetes to the drug's tolerability, the transcript shows."
What is compelling about the internal documents that have been released through the WSJ is the process in which obviously well-intentioned people begin the slide toward corrupt practices. In most respects, these documents are like many others that have come to light. The Ney directive, for example, reads more or less like "dodgeball" revisited. What distinguishes these documents, I think, is that some of them reflect the very moment of ethical choosing--where decisions are made either to suppress known data or not. It is relatively rare for the general public to get a glimpse at the process at that particular juncture.
Perhaps most compelling is an email from John Tumas, one of the AZ publication managers involved in decisions about whether or not to suppress negative studies. In a confidential 1999 email ("Exhibit 13"), Tumas writesto his colleagues:
"Please allow me to join in the fray
There has been a precedent set regarding 'cherry picking' of data. This would be the recent Velligan presentations of cognitive function data from Trial 15 (one of the buried trials). Thus far, I am not aware of any repercussions regarding interest in the unreported data.
That does not mean that we should continue to advocate this practice. There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried Trials 15, 31, 56, and are now considering COSTAR [a trial comparing Seroquel to Risperdal].
The larger issue is how do we face the outside world when they begin to criticize us for suppressing data. One could say that our competitors indulge in this practice. However, until now, I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue to enjoy this distinction.
The reporting of the COSTAR results will not be easy. We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.
Best regards,
John"
There are many ways to read this note. Tumas searches for a middle way--not to "bury" this trial, as others have been buried, but to "diminish the negative findings." The importance of AZ's relatively good ethical reputation (particularly in comparison with Janssen, as other communications make clear) is not trivial. But it is a "distinction" which may or may not be worth trading away.
I will save wider reflections for another post. Here, I will simply say that I do not believe any system of exteral _sanctions_--criminal, civil, or regulatory--will be the key that impacts decisions like the one with which John Tumas struggles. It is rather about reputation (facing the "outside world"), about competition, and--perhaps on some level--about living with oneself. The last, sad to say, is speculative. Either way, Tumas is not directly worried about trial lawyers or the FDA/DOJ. He is worried about Janssen. And, further out on the horizon, about "pressure" to provide access to all data. And, even further out, about some vague sense that someday it could all unravel. As, of course, it now has. [Tumas could "not be reached for comment" the Journal reports.]
On one level, these are issues of the moral choices that individuals make. On another, these are issues about a business model and incentive structure that make moments like Tumas's not only possible, but ubiquitous. That is to say, entirely typical.
I do not think it is an overstatement to suggest that Tumas's decision can stand as a microcosm for the industry as a whole. And the core question is whether the business model and incentive structure can be changed in ways that save people like Tumas from, almost inadvertently, doing moral violence both to themselves and, not long after, to a great many others.
*********************************************************************************
Addendum: The NYT version of the story can be found at:
http://www.nytimes.com/2009/02/28/business/28drug.html?_r=1&emc=tnt&tntemail1=y
As many here will know, there have been a number of stories today about Astra Zeneca's alleged cover-up of studies indicating the diabetes risks of Seroquel. The Wall Street Journal Stories have been particularly informative. Here is a brief snippet (which will remind some of you of our peanut thread--truth is sometimes a lot like fiction):
"In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a "weight and diabetes sell sheet" they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug.
"Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile," Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to "refocus the call" away from diabetes to the drug's tolerability, the transcript shows."
What is compelling about the internal documents that have been released through the WSJ is the process in which obviously well-intentioned people begin the slide toward corrupt practices. In most respects, these documents are like many others that have come to light. The Ney directive, for example, reads more or less like "dodgeball" revisited. What distinguishes these documents, I think, is that some of them reflect the very moment of ethical choosing--where decisions are made either to suppress known data or not. It is relatively rare for the general public to get a glimpse at the process at that particular juncture.
Perhaps most compelling is an email from John Tumas, one of the AZ publication managers involved in decisions about whether or not to suppress negative studies. In a confidential 1999 email ("Exhibit 13"), Tumas writesto his colleagues:
"Please allow me to join in the fray
There has been a precedent set regarding 'cherry picking' of data. This would be the recent Velligan presentations of cognitive function data from Trial 15 (one of the buried trials). Thus far, I am not aware of any repercussions regarding interest in the unreported data.
That does not mean that we should continue to advocate this practice. There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried Trials 15, 31, 56, and are now considering COSTAR [a trial comparing Seroquel to Risperdal].
The larger issue is how do we face the outside world when they begin to criticize us for suppressing data. One could say that our competitors indulge in this practice. However, until now, I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue to enjoy this distinction.
The reporting of the COSTAR results will not be easy. We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.
Best regards,
John"
There are many ways to read this note. Tumas searches for a middle way--not to "bury" this trial, as others have been buried, but to "diminish the negative findings." The importance of AZ's relatively good ethical reputation (particularly in comparison with Janssen, as other communications make clear) is not trivial. But it is a "distinction" which may or may not be worth trading away.
I will save wider reflections for another post. Here, I will simply say that I do not believe any system of exteral _sanctions_--criminal, civil, or regulatory--will be the key that impacts decisions like the one with which John Tumas struggles. It is rather about reputation (facing the "outside world"), about competition, and--perhaps on some level--about living with oneself. The last, sad to say, is speculative. Either way, Tumas is not directly worried about trial lawyers or the FDA/DOJ. He is worried about Janssen. And, further out on the horizon, about "pressure" to provide access to all data. And, even further out, about some vague sense that someday it could all unravel. As, of course, it now has. [Tumas could "not be reached for comment" the Journal reports.]
On one level, these are issues of the moral choices that individuals make. On another, these are issues about a business model and incentive structure that make moments like Tumas's not only possible, but ubiquitous. That is to say, entirely typical.
I do not think it is an overstatement to suggest that Tumas's decision can stand as a microcosm for the industry as a whole. And the core question is whether the business model and incentive structure can be changed in ways that save people like Tumas from, almost inadvertently, doing moral violence both to themselves and, not long after, to a great many others.
*********************************************************************************
Addendum: The NYT version of the story can be found at:
http://www.nytimes.com/2009/02/28/business/28drug.html?_r=1&emc=tnt&tntemail1=y
Labels:
Astra Zeneca,
corruption,
Seroquel,
supressing,
Tumas
Subscribe to:
Posts (Atom)