8/6/08
THE EXPENSE OF FREE SPEECH
By
Richard Davis
GUILFORD-. Last week a case played out in Federal Court in Brattleboro that revolved around the free speech rights of the pharmaceutical industry. The big boys are crying foul and saying that a new Vermont law, Act 80, will drive up drug prices and stifle innovation. It’s hard to have a lot of sympathy for an industry that is perhaps the most profitable on the planet (neck and neck with the oil companies), an industry that profits from the sickest and most vulnerable people in our society.
The Vermont legislature passed Act 80 this year and it has a provision that allows the state to prevent drug companies and data companies from using what is called “prescriber identifiable data”. The drug and data companies contend that this information is speech and, as such, they have a constitutional right to that information. Their premise is that by not having free access to that information their free speech rights are being violated.
Similar laws in New Hampshire and Maine were struck down on those grounds. But the Vermont law has an opt-out provision for prescribers and that means they can simply indicate they do not want their information shared. Prescribers who do not opt out will have their information bought and sold at obscenely high prices. None of the prescribers will profit from transactions that push already ridiculously inflated drug prices to new heights .
Issues in this case revolve, in large measure, around the activities of drug detailers. They are the sales people employed by the drug manufacturers who go to doctors’ offices, hospitals and other health care locations to try to persuade prescribers to use their products. Their bosses will tell you they provide a valuable educational service to doctors who don’t have the time to learn about new drugs.
Their bosses also contend that the best way for these detailers to do their job is to have access to all of the prescribing information of doctors. Here’s how it works. Data mining companies such as IMS, one of the plaintiffs in this case, develop contracts with pharmacies and buy information that tells them what prescriptions doctors are writing. That information is then sold to the drug manufacturers who use it to target their sales pitches to doctors.
There was testimony from Scott Tierney, Director of Managed Care Operations for CVS/Caremark, the largest provider of prescriptions in the U.S. CVS provides data to IMS and Verispan and that is a source of revenue for CVS. CVS does not tell MDs that CVS is selling the prescriber identifiable data, but Tierney said they do tell customers of CVS. You can bet your last dose of Prilosec that all of these activities drive up the cost of the drugs we all struggle to pay for.
Testimony from Mr. Robertson, the Assistant VP for Sales, Planning and Inserts for Wyeth, one of the world’s largest pharmaceutical manufacturers, provided insight into how drug detailers are trained and how they operate.
Here’s a breakdown of Wyeth’s U.S. field sales force:
1500 for family practice and internal medicine
300 for psychiatrists
400 for institutions (hospitals and teaching hospitals)
80 for rheumatology
85 for oncology
17 for Hemophilia
Sales reps receive 9-12 months of training which is a combination of home study, online work and classroom training. Most training is geared to having them know what is on the medication package inserts.
According to Robertson, Wyeth uses prescriber identifiable data purchased from IMS to “know which physicians it is effective for sales reps to call on, to see which products in our portfolio physicians may have the most interest in.”
It was revealed that the average length of face-to-face interaction between MDs and sales reps is 2 to 2.5 minutes. When asked what purpose giving samples to MDs serves Robertson said that it is to see if MDs can get the desired therapeutic effect and to titrate dosage. If you willingly swallow that bitter pill then you probably believe we are fighting a war in Iraq because weapons of mass destruction are a threat to the United States.
The Vermont defense attorney asked Robertson if he considered the drug industry to be competitive. He danced around the question and wouldn’t explicitly state that it was competitive. Good coaching by the plaintiffs no doubt, or just a lot of experience bending the truth.
Sales reps receive a salary and they “make more money if they achieve or exceed their goals”, according to Robertson. Goals are the number of prescriptions in their territory. Supervisors make more money if the sales reps make more money.
Perhaps one of the most revealing questions that I heard was asked by the Vermont attorney. “Couldn’t sales reps get the prescriber information they are looking for during a visit to a doctor?” Robertson answered “Yes” but said it would be more “efficient” to buy the prescriber identifiable data.
Draw your own conclusions. I will be writing more about this trial in the coming weeks. Judge Murtha will be deliberating over this case so public discussion is important.
Thursday, August 7, 2008
IMS. v. Sorrell, August 1, 2008
August 1, 2008
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
August 1 was the final day of the trial. I did not stay for closing arguments but here are some bits and pieces.
There was testimony from Dr. Kesselheim, a lawyer and MD who practices in Boston and also does work on drug policy research and prescription drug practices and development. He provided a statement of support to the Vermont legislature for Act 80 because he said it would, “positively impact patient health and safety.” He went on to say that, “It is a good law that will improve patient safety and lower costs. This law will prevent overuse and inappropriate use of prescription drugs.
Kesselheim got into the alternative practice of academic detailing whereby academic medical centers train people to educate doctors about drugs rather than drug company sales reps. His institution has a pilot academic detailing project ongoing in Pennsylvania.
Kesselheim gave an example of the cost of overprescribing using the example of hydrochlorothiazide(HCTZ) in the 1990’s. HCTZ is an effective, generic first line treatment for high blood pressure but drug companies pushed the use of more expensive calcium channel blockers. He noted that this, “led to billions of dollars in excess cost to government programs and increased the cost of co-pays to people in government supported programs.”
Attorney Weiner for PhRMA began his closing argument with a predictable defense saying, “The State of Vermont has directly infringed on the free speech of PhRMA members and that there is no compelling state interest.” In a statement that could cut both ways he said, “Center stage is the doctor/patient relationship.”
Judge Murtha will deliberate and it could take 4-6 weeks before a decision is rendered.
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
August 1 was the final day of the trial. I did not stay for closing arguments but here are some bits and pieces.
There was testimony from Dr. Kesselheim, a lawyer and MD who practices in Boston and also does work on drug policy research and prescription drug practices and development. He provided a statement of support to the Vermont legislature for Act 80 because he said it would, “positively impact patient health and safety.” He went on to say that, “It is a good law that will improve patient safety and lower costs. This law will prevent overuse and inappropriate use of prescription drugs.
Kesselheim got into the alternative practice of academic detailing whereby academic medical centers train people to educate doctors about drugs rather than drug company sales reps. His institution has a pilot academic detailing project ongoing in Pennsylvania.
Kesselheim gave an example of the cost of overprescribing using the example of hydrochlorothiazide(HCTZ) in the 1990’s. HCTZ is an effective, generic first line treatment for high blood pressure but drug companies pushed the use of more expensive calcium channel blockers. He noted that this, “led to billions of dollars in excess cost to government programs and increased the cost of co-pays to people in government supported programs.”
Attorney Weiner for PhRMA began his closing argument with a predictable defense saying, “The State of Vermont has directly infringed on the free speech of PhRMA members and that there is no compelling state interest.” In a statement that could cut both ways he said, “Center stage is the doctor/patient relationship.”
Judge Murtha will deliberate and it could take 4-6 weeks before a decision is rendered.
IMS v. Sorrell , July 30, 2008
July 30, 2008
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
The State of Vermont seemed to do a better job of rebutting some of the “expert witness” testimony that was carefully crafted by the plaintiff team of lawyers. Mr. Robertson, the Assistant VP for Sales, Planning and Insights for Wyeth provided a lot of insight into how drug detailers are trained and how they operate.
Here’s the number of Wyeth’s sales force in the field- the cover the entire U.S.:
1500 for family practice and internal medicine
300 for psychiatrists
400 for institutions (hospitals and teaching hospitals)
80 for rheumatology
85 for oncology
17 for Hemophilia
Sales reps receive 9-12 months of training which is a combination of home study, online work and classroom training. Most training is geared to having them know what is on the medication package inserts.
According to Robertson Wyeth uses prescriber identifiable data purchased from IMS to “know which physicians it is effective for sales reps to call on, to see which products in our portfolio physicians may have the most interest in.”
It was revealed that the average length of face-to-face interaction between MDs and sales reps is 2 to 2.5 minutes. When asked what purpose giving samples to MDs serves Robertson
said that it is to see if MDs can get the desired therapeutic effect and to titrate dosage.
The Vermont attorney asked Robertson if he considered the drug industry to be competitive. He danced around the question and wouldn’t explicitly state that it was competitive.
Sales reps receive a salary and they “make more money if they achieve or exceed their goals”. Goals are the number of prescriptions in their territory. Supervisors make more money if the sales reps make more money.
Perhaps the most important question asked by the Vermont attorney in relation to the issue of the case “Couldn’t sales reps get the prescriber information they are looking for during a visit to a doctor?” Robertson answered “Yes” but said it would be more “efficient” to buy the prescriber identifiable data.
There was testimony from Scott Tierney, Director of Managed Care Operations for CVS/Caremark, the largest provider of prescriptions in the U.S. CVS provides data to IMS and Verispan and that is a source of revenue for CVS. CVS does not tell MDs that CVS is selling their data but Tierney said they do tell customers of CVS.
There was testimony from Michael Turner, President of the Political and Economic Research Council. He said that the State of Vermont should have followed his recommended procedures to validate reasons for not allowing the use of identifiable data, basically the premise of the section in contention in Act 80. He said the state made unsubstantiated assertions. In order to do what Turner said the state should do would require 9-12 months of work at a cost of $700,000-$900,000. I did not stay for the state’s cross examination of Turner.
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
The State of Vermont seemed to do a better job of rebutting some of the “expert witness” testimony that was carefully crafted by the plaintiff team of lawyers. Mr. Robertson, the Assistant VP for Sales, Planning and Insights for Wyeth provided a lot of insight into how drug detailers are trained and how they operate.
Here’s the number of Wyeth’s sales force in the field- the cover the entire U.S.:
1500 for family practice and internal medicine
300 for psychiatrists
400 for institutions (hospitals and teaching hospitals)
80 for rheumatology
85 for oncology
17 for Hemophilia
Sales reps receive 9-12 months of training which is a combination of home study, online work and classroom training. Most training is geared to having them know what is on the medication package inserts.
According to Robertson Wyeth uses prescriber identifiable data purchased from IMS to “know which physicians it is effective for sales reps to call on, to see which products in our portfolio physicians may have the most interest in.”
It was revealed that the average length of face-to-face interaction between MDs and sales reps is 2 to 2.5 minutes. When asked what purpose giving samples to MDs serves Robertson
said that it is to see if MDs can get the desired therapeutic effect and to titrate dosage.
The Vermont attorney asked Robertson if he considered the drug industry to be competitive. He danced around the question and wouldn’t explicitly state that it was competitive.
Sales reps receive a salary and they “make more money if they achieve or exceed their goals”. Goals are the number of prescriptions in their territory. Supervisors make more money if the sales reps make more money.
Perhaps the most important question asked by the Vermont attorney in relation to the issue of the case “Couldn’t sales reps get the prescriber information they are looking for during a visit to a doctor?” Robertson answered “Yes” but said it would be more “efficient” to buy the prescriber identifiable data.
There was testimony from Scott Tierney, Director of Managed Care Operations for CVS/Caremark, the largest provider of prescriptions in the U.S. CVS provides data to IMS and Verispan and that is a source of revenue for CVS. CVS does not tell MDs that CVS is selling their data but Tierney said they do tell customers of CVS.
There was testimony from Michael Turner, President of the Political and Economic Research Council. He said that the State of Vermont should have followed his recommended procedures to validate reasons for not allowing the use of identifiable data, basically the premise of the section in contention in Act 80. He said the state made unsubstantiated assertions. In order to do what Turner said the state should do would require 9-12 months of work at a cost of $700,000-$900,000. I did not stay for the state’s cross examination of Turner.
IMS v. Sorrell, July 29, 2008
July 29, 2008
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
It is clear that the State of Vermont is outgunned and outclassed at every turn. I listened to the testimony of Peter Hutt who is a strong defender of drug companies. Clearly a smart legal scholar and Washington insider. His personal story makes it clear why the drug industry continues to call the shots.
Hutt worked for the FDA for 5 years as Chief Counsel then joined a DC law firm representing PHRMA and he lobbied for drug companies. He boasted how he has served on the board of 20 biotech companies. Quotes from Hutt tell it all.
“Profits are essential to fuel the discovery of new drugs to help all of us.”
“The pharmaceutical industry can only exist if it makes a profit. A shift to generics will cause the price of drugs to go up or development will decrease.”
“Act 80 will harm patient health because patients who need new drugs will be denied those drugs when they could be tremendously helpful.”
“You get what you pay for. We must have high enough drug prices to fuel drug development. If we start hindering the marketing and sales of drug companies it will decrease development of new drugs.”
Cross examination of Hutt by the state was weak at best. He opened the door to show how the profits are excessive and how they result in the deaths of people. They could have made a more compelling case for the use of generic drugs as something in the best interest of Vermonters thereby negating the contention that brand drugs are best for everyone.
One can only hope that Judge Murtha will see through the drug industry smokescreen and render a decision that is truly in the best interest of Vermonters.
Hutt had the chutzpa to say that the studies contending that thiazide-type diuretics provide just as good treatment of hypertension as newer more expensive drugs as flawed. He then said thiazides are no safer than new drugs. That was a simple lie. Following his statement he then made more statements in defense of profits and trashing widespread use of generics as something harmful to drug company profits.
IMS V. SORRELL
FEDERAL COURT, BRATTLEBORO
It is clear that the State of Vermont is outgunned and outclassed at every turn. I listened to the testimony of Peter Hutt who is a strong defender of drug companies. Clearly a smart legal scholar and Washington insider. His personal story makes it clear why the drug industry continues to call the shots.
Hutt worked for the FDA for 5 years as Chief Counsel then joined a DC law firm representing PHRMA and he lobbied for drug companies. He boasted how he has served on the board of 20 biotech companies. Quotes from Hutt tell it all.
“Profits are essential to fuel the discovery of new drugs to help all of us.”
“The pharmaceutical industry can only exist if it makes a profit. A shift to generics will cause the price of drugs to go up or development will decrease.”
“Act 80 will harm patient health because patients who need new drugs will be denied those drugs when they could be tremendously helpful.”
“You get what you pay for. We must have high enough drug prices to fuel drug development. If we start hindering the marketing and sales of drug companies it will decrease development of new drugs.”
Cross examination of Hutt by the state was weak at best. He opened the door to show how the profits are excessive and how they result in the deaths of people. They could have made a more compelling case for the use of generic drugs as something in the best interest of Vermonters thereby negating the contention that brand drugs are best for everyone.
One can only hope that Judge Murtha will see through the drug industry smokescreen and render a decision that is truly in the best interest of Vermonters.
Hutt had the chutzpa to say that the studies contending that thiazide-type diuretics provide just as good treatment of hypertension as newer more expensive drugs as flawed. He then said thiazides are no safer than new drugs. That was a simple lie. Following his statement he then made more statements in defense of profits and trashing widespread use of generics as something harmful to drug company profits.
IMS v. Sorrell July 28, 2008
IMS v. Sorrell
Federal Court Brattleboro
July 28, 2008
Today in Federal court in Brattleboro a trial dealing with the Vermont prescription drug law, Act 80, began. Plaintiffs are IMS* and our dear friends PHARMA. The State of Vermont is the defendant. The big issue is whether or not drug companies and information sellers have a right to the information about the prescribing practices of doctors. A similar law was struck down in NH and Maine. The Vermont law differs a little in that MDs can opt out of information sharing.
I am not a lawyer. I will be attending some of the proceedings and will provide my personal biased summaries.
There were 7 lawyers from the dark side and two techies with 4 laptops. The state had, I think, 4 lawyers. The state is clearly outclassed and it is truly a David versus Goliath trial. I did not see any media in the courtroom.
The IMS and Pharma argument is based on constitutional free speech issues. They claim that not allowing to have the information is the same as restricting free speech. They claim IMS is the same as the New York Times (major stretch but perhaps legally defensible) and that they are just another publisher.
The state used a lot of quotes from Marcia Angell and others about obscene pharmaceutical profits and the state tried to lay out an argument that they are acting in the interest of all Vermonters when they do things to try to control the price of drugs.
But, the case will be decided on the merits of specific legal points. If more members identifiable as the public were in the courtroom it might provide an interesting perspective for Judge Murtha.
I did not stay for the afternoon. I left during testimony by an IMS operative.
*IMS is a company that gathers data and then sells it to mostly drug companies.
Federal Court Brattleboro
July 28, 2008
Today in Federal court in Brattleboro a trial dealing with the Vermont prescription drug law, Act 80, began. Plaintiffs are IMS* and our dear friends PHARMA. The State of Vermont is the defendant. The big issue is whether or not drug companies and information sellers have a right to the information about the prescribing practices of doctors. A similar law was struck down in NH and Maine. The Vermont law differs a little in that MDs can opt out of information sharing.
I am not a lawyer. I will be attending some of the proceedings and will provide my personal biased summaries.
There were 7 lawyers from the dark side and two techies with 4 laptops. The state had, I think, 4 lawyers. The state is clearly outclassed and it is truly a David versus Goliath trial. I did not see any media in the courtroom.
The IMS and Pharma argument is based on constitutional free speech issues. They claim that not allowing to have the information is the same as restricting free speech. They claim IMS is the same as the New York Times (major stretch but perhaps legally defensible) and that they are just another publisher.
The state used a lot of quotes from Marcia Angell and others about obscene pharmaceutical profits and the state tried to lay out an argument that they are acting in the interest of all Vermonters when they do things to try to control the price of drugs.
But, the case will be decided on the merits of specific legal points. If more members identifiable as the public were in the courtroom it might provide an interesting perspective for Judge Murtha.
I did not stay for the afternoon. I left during testimony by an IMS operative.
*IMS is a company that gathers data and then sells it to mostly drug companies.
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