Wednesday, August 22, 2007

Minnesota Medicaid, Big Pharma and Delusions about Conflict of Interest

Roy Poses posted previously at "US States Using Pharmaceutical Company Funded Program to Influence Physicians' Prescribing " on how Minnesota, and other US states, use a program funded by Eli Lilly & Co which is meant to reduce physicians' supposedly inappropriate use of anti-psychotic medications. Eli Lilly is also the manufacturer of one such medication, olanzapine (Zyprexa). The source article noted that states that use the Lilly program seem to have adopted policies that tend to favor Lilly and its products, and that neither Minnesota nor the other states that use the Lilly program uses prior authorization schemes to limit drug use.

More on Minnesota today.

In "Drugmakers' deep pockets linked to decision-makers", Martiga Lohn today describes the effects of a new Minnesota law: shining of a rare light onto 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.

The article is striking in several respects.

Drugmakers' deep pockets linked to decision-makers

By Martiga Lohn, Associated Press

ST. PAUL, Minn. - A groundbreaking Minnesota law is shining a rare light onto 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.

Those panels, most composed of physicians, hold great sway over the $28 billion spent on drugs each year for Medicaid patients nationwide. Yet only three states - Maine, Vermont and Minnesota - require drug companies to report payments to doctors for lectures, consulting, research and other services.

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

The online version of the story does not contain a chart in the print version entitled "Tracking Spending on Advisry Panels" that lists the major pharmas and their payments to two people, Dr. John E. Simon and pharmacist Robert Straka.

From 1998-2006 Dr. Simon, a psychiatrist, received $582,469.97 (over $350,000 from 2004-6 alone as a member of the panel) and Mr. Straka $85,807.95 (served on the panel from 2000 to 2006, and collected $78,000 during that time from various drugmakers), according to the article and chart.

Eli Lilly was the largest single contributor, having given psychiatrist Dr. Simon $488,952. Merck and Schering-Plough were the largest "contributors" to Straka, having given $24,623 and $36,745 respectively.

Back to the article:

Both said the money did not influence their work on the panel, and spokesmen for the drug companies said their payments had nothing to do with the members' roles.

Let's put, say, $489 thousand dollars into perspective. What might that amount buy?

Assuming after taxes that a bit over $300,000 were left:
Dutch automaker Spyker makes several different editions of its C8 supercar. The most expensive one is the $326,000 C8 Double 12 S.

Rolls-Royce Phantom: MSRP: $333,350. The 2007 Phantom is a 4-door, up to 5-passenger luxury sedan, available in one trim only, the Sedan. Upon introduction, the Phantom is equipped with a standard 6.75-liter, V12, 453-horsepower engine that achieves 12-mpg in the city and 19-mpg on the highway. A 6-speed automatic transmission with overdrive is standard.

Aston Martin DB9 MSRP $169,750 - $183,250 (Name's Bond. James Bond. why settle for one when $300K+ can buy two!)

For the numismatists among us:
Large One-Cent Pieces, Flowing Hair, Chain Reverse 1793 Periods $304,000
Half-Cent Pieces, Liberty Cap 1796 With pole $303,000
Half Eagles ($5.00 Gold Pieces), Capped Bust 1797 Large eagle $301,000
Silver Dollars, Flowing Hair 1795 $299,000

And for the boaters among us:
30 Express Rampage Sportfishing Yacht $200,000-$300,000

Those who say that this amount of money from pharma "did not influence their work" on such decision-making committees are either in serious denial, deluded or dishonest, in my opinion. It is risible to say that these amounts could not influence decisions - or not be perceived to influence decisions by the reasonable man or woman.

Those who think that payments like this do not present a most disastrous appearance are certainly in denial or deluded about issues of public trust:

The advisory panel's recommendations to the Minnesota Human Services Department are almost always followed. The panel guided $240 million in spending on drugs for 202,000 patients last year - slightly less than a third of all the state's Medicaid patients.

The top drugs for Minnesota Medicaid patients covered by the panel's advice in recent years have been for schizophrenia - Eli Lilly & Co.'s Zyprexa, from 2000 to 2004, and AstraZeneca PLC's Seroquel, in 2005 and 2006.

About a third of the drugs on the state's preferred list are made by companies that paid Simon, Straka or both.

Here's another major part of the problem:
The lack of recorded votes in meeting minutes makes it difficult to track any link between payments and policy.

That is simply incredible. In Minnesota, not only were these activities conducted with little or no public scrutiny before the new law went into effect, but also minutes were not taken to see who was voting for what.

Finally:

... State officials said they would examine the panel's past actions for any bias tied to the payments, and they would start screening appointees to two dozen advisory councils for similar links. They will also require the Drug Formulary Committee to record how members vote.

Other states need to do likewise. Fast.

A List of drug companies' payments to doctors in Minnesota is also available.

-- SS

4 comments:

Daniel said...

MI,

Though I agree with your general point, as someone who researches, writes, and speaks on COI between industry and clinicians, I think it's really important to move beyond thinking about the egregiousness of the COI in relation to the value of the gift.

The extensive social science literature on the nature of gifts shows quite dramatically that the relationship facilitated by the gift exchange depends little on the value of the gift exchanged. The symbolic act of accepting a gift tends to create a feeling of indebtedness, a desire to reciprocate that is not highly correlated with the value of the gift itself.

Accordingly, ethicists and like-minded scholars have been beating the drum for some time that the ethical problems related to gift-giving are not contingent on the value of the gift. They inhere, rather, in the nature of the gifting relationship.

There's lots of good sources on this, if anyone is interested I can supply some cites.

www.medhumanities.org

MedInformaticsMD said...

I think it's really important to move beyond thinking about the egregiousness of the COI in relation to the value of the gift...the ethical problems related to gift-giving are not contingent on the value of the gift.

While no conflict of interest is a good thing, I will leave it to the readership to decide if, say, a "gift" of $500,000 vs., say, $500, or a $5 coffee mug, could reasonably be expected not to affect relationships differently, and that the nature of the COI overrides these order-of-magnitude differences.

-- SS

Daniel said...

SS,

I did not say that the value of the gift had no effect on the relationships.

My point was that a great body of literature suggests that the assumption that a gift of minimal value has no effect on behavior is contraverted by a plethora of empirical evidence. Accordingly, IMO, in thinking about COIs, it would be advantageous to move beyond simply looking at the value of the gift in deciding whether the conduct at issue is appropriate.

The value of the gift is relevant, but it ought not be taken as the whole of the ethical inquiry, which is what it is often taken to be.

Sheldon Krimsky has some excellent analysis on this in his tour de force, Science in the Private Interest.

MedInformaticsMD said...

My point was that a great body of literature suggests that the assumption that a gift of minimal value has no effect on behavior is contraverted by a plethora of empirical evidence.

Thanks for the clarification.

The best rule is: if you have a conflict of interest, end it before sitting on a decision making body.

And, to paraphrase my former employer Merck's guidance to employees, if you are doing something that would look bad in the print media, it probably is not a 'righteous' activity.