Tuesday, August 21, 2007


I guess as long as you admit that you are taking money from a drug company, that makes the conflict of interest go away?

Mr. B. has previously posted on the formation of a task force at BigU to probe doctors on the dole.

Judging by two recent news items, I hope that this task force is hard at work as I write, because they have a lot to do and it is important. As I mentioned in an earlier post:

It is a little hard to take advice from an institution that seems to be reluctant to discuss its own apparent ethical problems. Let's just hope that the doctors heading the task force are people respected throughout the community for their integrity, fairness, and independence. Otherwise such a task force is not going to be particularly credible.”

From the Pioneer Press:

Minnesota / Lilly link to state program questioned

Critics see a conflict of interest in drugmaker's health plan role

Pioneer Press

Article Last Updated:08/20/2007 12:06:07 AM CDT

One of the nation's largest drug companies is helping Minnesota cut costs and reduce questionable prescriptions of psychiatric drugs to poor and disabled residents.

While Eli Lilly provides this guidance without charge, critics believe it's the "fox watching the henhouse," because the company has a financial interest in encouraging state policies that increase drug sales.

If the state "asks Eli Lilly to help decide how to buy prescription drugs, or even General Motors to help decide how to buy a car, I guess I'm going to be concerned about that," said Ronald Hadsall, assistant dean of the University of Minnesota College of Pharmacy. "That just smacks of conflict to me."

Officials with the Minnesota Department of Human Services defended the program, which is funded by Lilly but run by an independent contractor, Comprehensive NeuroScience. State officials believe CNS has saved money for Minnesota's fee-for-service health plans, but more important, it has corrected some questionable prescriptions of expensive and powerful psychiatric drugs.

"Cost is an issue, certainly, but what is most important is that we get the right health care for patients," said Brian Osberg, assistant commissioner of the human services department.

Twenty states have contracts with CNS, which identifies doctors who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness. A common problem is patients taking two or three antipsychotic drugs at once, despite an increased risk of side effects and no evidence that patients benefit by taking multiple drugs.

The states then send warning letters to doctors, who can decide whether to alter their prescriptions.

Opponents believe states are paying Lilly back for this help by keeping its drugs off prior-authorization lists. Such lists prohibit doctors from prescribing drugs without first gaining permission from the state.

Lilly is the manufacturer of Zyprexa, a top-selling antipsychotic drug. Minnesota's fee-for-service health plans spent more than $28 million on Zyprexa in 2005, and $103 million on antipsychotics in general. That more than doubled the 2000 total of $43 million for the plans, which cover 200,000 poor and disabled Minnesotans.

While other states have used prior authorization to curb these soaring costs, Minnesota has not. In fact, none of the states with Lilly partnerships use prior authorization to manage antipsychotic drugs.

Wisconsin had a contract with Lilly until last year, when the state's Medicaid agency placed antipsychotic drugs, including Zyprexa, on the prior authorization list. State officials were informed shortly thereafter that Lilly was canceling the program.

A Lilly spokeswoman acknowledged that the company is trying to discourage states from using prior authorization. "We just feel the doctor should be in the driver's seat as far as picking the best medication, especially an antipsychotic," said Janice Chavers. "It's not like taking a cold medication."

In opposing prior authorization, Lilly has a long list of allies, including doctors and patients who feel it disrupts their relationship. Mental health advocates also argue that prior authorization cuts off drugs from needy patients, who then end up needing more expensive hospital care.

There is little question prior authorization reduces drug costs, though. Wisconsin saved $4 million after placing restrictions on antipsychotics, despite losing its contract with Lilly.

Some states have reported savings with the Lilly partnership as well. Michigan's spending on mental health drugs dropped 21 percent in six months.

Even if states benefit, there is little question Lilly has a profit motive, said Tom Croghan, a former Lilly executive who conducts health policy research for Mathematica Inc. Drug companies are happy to prevent excessive prescribing of pills to some people, he said, if they can encourage state policies that keep the drugs widely available to others.

"Drug companies are interested in selling their pills and selling as many as they can," he said.

The Lilly program targets what one Minnesota psychiatrist referred to as "lazy" prescribing.

When a patient is hospitalized, the inpatient psychiatrist might prescribe a new antipsychotic but won't take the patient off the old one, said Dr. David Adson of the University of Minnesota. Then the outpatient doctor simply leaves the patient on multiple drugs.

As the clinical lead of the CNS project, Adson signs each letter sent by the state to doctors with questionable prescriptions, including unusually high or low doses, or hasty switches from one drug to another.

The number of patients on three or more antipsychotics dropped from 76 in November 2005 to 27 in August 2006, according to a state review of the program.

A state study of the program suggests doctors change questionable prescriptions more quickly when they receive the warning letters. However, the doctors still change the prescriptions over time without the letters. The study also found only modest cost savings.

A Michigan critic believes Lilly is profiting from its partnership with Minnesota. In February, Minnesota encouraged patients to split cheaper double-strength pills instead of taking multiple smaller-dose pills, which can save money for the state at the expense of drugmakers.

The "dose optimization" strategy was required for Abilify, Geodon and Seroquel - which are competing antipsychotic drugs - but not for Zyprexa.

"Pure coincidence that dose optimization and tablet splitting are utilized exclusively for Eli Lilly's competitors?" asked Ben Hansen, who has sued to expose Michigan's partnership with Lilly. "I don't think so."

Human services officials replied that there was no financial benefit to placing Zyprexa on the pill-splitting list.

The Lilly contract ends in February, but may be renewed. While the program hasn't cut drug costs, state officials are studying whether it saved administrative costs and reduced spending on mental health services.

(In the interest of fairness the tennis game is faithfully reported marred only by Mr. B.’s text bolding.)

Along the above lines further information has surfaced, this time involving some more major money and even a BigU pharmacy prof. Excerpted from the AP:

A groundbreaking Minnesota law is shining a rare light into the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled.

An Associated Press review of records in Minnesota found that a doctor and a pharmacist on the eight-member state panel simultaneously got big checks _ more than $350,000 to one _ from pharmaceutical companies for speaking about their products.

The two members said the money did not influence their work on the panel, and the lack of recorded votes in meeting minutes makes it difficult to track any link between the payments and policy.

But ethical experts said the Minnesota data raise questions about the possibility of similar financial ties between the pharmaceutical industry and advisers in other states.

"In the absence of disclosure laws, there's certainly no way to know," said Jack Hoadley, a research professor specializing in Medicaid at Georgetown University in Washington. "There are a lot of physicians in general who have at least some contract or grant funding out of pharmaceutical companies, and additional (who) do speaking engagements."

John E. Simon, a psychiatrist appointed to the panel in 2004, earned more than $350,000 from drug companies between 2004 and 2006. Pharmacist Robert Straka served from 2000 to 2006 and collected $78,000 from various drug makers during that time.

Both men, and the committee chairman, said the payments did not influence their work with the committee.

But state officials said they would examine the panel's past actions for any bias tied to the payments, and they will start screening appointees to more than two dozen advisory councils for similar links to the drug industry.

They will also require the Drug Formulary Committee to begin recording how each member votes at its meetings.

The top drugs for Minnesota Medicaid patients covered by the panel's advice in recent years have been schizophrenia treatments from Eli Lilly & Co. and AstraZeneca PLC _ Lilly's Zyprexa from 2000 to 2004, followed by AstraZeneca's Seroquel in 2005 and 2006. About a third of the drugs on the state's preferred drug listare made by companies that paid Simon, Straka or both.

A medical ethicist said state drug advisers should not take pharmaceutical companies' money because of the power the panel exercises over the poorest, most vulnerable patients.

"This is a high-stakes committee," said Dr. Arthur Caplan, chairman of medical ethics at the University of Pennsylvania School of Medicine. "If you're going to have your hand on that tiller, you don't want to think that anybody is trying to push it."

Some other states have taken tough measures to guard against that. Nevada bars anyone from serving on its Pharmacy and Therapeutics Committee who is in any way paid by or affiliated with a corporation that makes prescription drugs.

"It's as clean as we can get or we can dream up," said Charles Duarte, the state's Medicaid administrator.

In Idaho, committee members can be fired on the spot for failing to disclose a conflict of interest.


Here's what the Minnesota records show:

Simon, a Minneapolis psychiatrist, earned $354,700 from companies including Eli Lilly and AstraZeneca from 2004 to 2006 in honoraria, speaker's and consulting fees, and other payments ranging from $500 to $93,012. His stint on the formulary committee began in June 2004.

Simon said he should be able to vote on drugs made by the companies that pay him, as long as they don't come from the neuroscience or psychiatric divisions that pay him. But, he said, he would not oppose a stricter standard.

"There's absolutely no record of my biasing in favor of one company or another or any of them," Simon said. "I figure the preferred drug should be the one that cuts the best deal with the state."

Spokesmen for Eli Lilly and AstraZeneca said their companies' relationships with Simon had nothing to do with his role on the panel.

Lilly spokesman Phil Belt said Simon even voted against Lilly products, including a growthhormone and an insulin.

"It just wouldn't be appropriate to assume or imply that our relationship with him is in any way a product of or influenced by his role on the Drug Formulary Committee," Belt said.

Straka, a University of Minnesota pharmacy professor, earned $78,100 in honoraria and other fees from 2000 to 2006, including $36,745 from Schering-Plough Corp. and $24,623 from Merck & Co. He served on the panel from September 2000 to March 2006.

Straka said he was paid for educational talks usually arranged by medical groups who lined up the sponsors. He said he routinely discloses his ties with drug makers and did so as a formulary committeemember, both verbally and in writing.

"I have no problem with the issue of fully disclosing things. I do that all the time," Straka said.

But a public records request by the AP turned up no information about Straka making such disclosures. Nor do such statements appear in the committee's minutes going back to February 2001. Other committee members and staff interviewed by AP could not recall him disclosing compensation from drug makers.

The information about Straka's earnings might not have come out at all, because drug companies are not required to disclose payments to pharmacists under the Minnesota law. Many did so anyway in his case, withsome listing him as an "M.D." in their reports.

Dr. William Korchik, the panel's chairman, said he supports disclosure of committee members' relationships with drug companies, "whether it's stock, research or speaker's fees."

Korchik said he didn't know the extent of the financial relationships until contacted by AP. But Korchik defended the panel's work, saying the ties did not bias a group that works mainly by consensus.

"This whole thing may be an issue of appearance of conflict, but I really feel comfortable that the committee has not been hoodwinked," he said.

Al Heaton, a pharmacist who has served on the committee since the early 1990s, is the only panel member mentioned in the last six years of minutes for disclosing a potential conflict of interest and abstaining from a vote _ on bone drugs he had gotten funding to research years earlier.

"I think that's important to know," said Heaton, the director of pharmacy at Blue Cross and Blue Shield of Minnesota.

"An individual may be perfectly honest and totally objective, but finding it out afterward, then you always wonder were they or were they not?"

Sorting out the good guys from the bad is left as an exercise for the reader. No doubt the great ethical thinkers at BigU's medical school will soon have it all sorted out.

Ciao, Bonzo