Grassley: Disclosure or Public Humiliation

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That is the question we are considering about this Sunday’s New York Times.  In an article Researchers Fail to Reveal Full Drug Pay reports that several well known psychiatrists are under scrutiny from Senator Grassley and possibly the government and their institutions for failing to disclose the extent of their relationships with industry. 

Senator Grassley’s statement in the congressional record describes a system of extrapolation for collecting the data. It included requests for information on payments to specific physicians from the supporters, institutions and the physicians themselves. 

Senator Grassley has a two-fold purpose for the release at this time:

A)   To send a message to NIH that they need to revamp their system of managing conflict of interest.

B)   To promote the Physician Payment Sunshine Act which is expected to be voted on in the coming weeks.

In a letter to NIH Senator Grassley starts out very critical of the institute:

Over the past number of years, I have become increasingly concerned about the lack of oversight regarding conflicts of interest relating to the almost $24 billion in annual extramural funds that are distributed by the NIH.

He is asking NIH to send over records for specific doctors outlined in his statement along with the names and records of any doctors who have been disciplined for failure to disclose.

Some examples of Senator Grassley’s seams very concerned with the quality of the disclosure he requested from Harvard physicians who are receiving remuneration for NIH grants.

The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money
they were making. But by looking at them, anyone would be led to believe that these doctors were not taking much money. Over the last 7 years, it looked like they had taken a couple hundred thousand dollars.
 

But last March, Harvard and Mass General asked these doctors to take a second look at the money they had received from the drug companies. And this is when things got interesting.

Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.
 

The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.

Based on reports from just a handful of drug companies, we know that even these millions do not account for all of the money. In a few cases, the doctors disclosed more money than the drug companies
reported. But in most cases, the doctors reported less money.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.”  

There are other more fuzzy numbers — rather than specific how much was received for what services, which would look a lot less nefarious, the article states that Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007; making the amount over $1million over 8 years to look impressive. Buried also is that in 2000, Dr. Biederman reported to Harvard that he received $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, not exactly enough to condemn a great scientist.  Having worked on campaigns, I am sure if checked the records from donors to the senators campaign in 2,000 you would find similar discrepancies.  .” (Peter Pitts in his column Gardiner and Grassley McCarthyite Mugging of Joe Biederman thinks this may be just bad bookkeeping)

It is interesting that the Times acknowledges Dr. Biederman’s accomplishments:

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. “

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

It is also interesting to note that they go out of their way to bring in critics including one from a fringe group the Alliance for Human Protection.

Using the Congressional Record and New York Times to embarrass researchers may serve a purpose, but is the court of public opinion the place to air these matters.  There is no evidence to lead us to believe that the Senator or the times ever met or interviewed these physicians to gain an understanding of their position.

This exercise shows how important it is for physicians to keep track of the remuneration they receive from industry for research, consulting and speaking.  It is no longer good enough to give ball park estimates especially if they are working on NIH supported grants.

Senator Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings and requesting even more additional information.  He placed the letters along with his comments in The Congressional Record.

Copies of documents are available by pressing the following links below:

Grassley Floor Statement June 4 2008

Grassley Letter to NIH June 4 2008 

Grassley Letter to Harvard June 4 2008 

Selective Disclosures for Harvard Doctors

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