Results tagged “Senate Committee on Aging” from Pathophilia

On July 6, 2009, for reasons that remain unclear, the Senate Special Committee on Aging sent a letter to Thomas Sullivan, president of Rockpointe Corporation, a private, 18-employee company that produces continuing medical education (CME) programs for physicians. The letter requested "an accounting of funding received by Rockpointe Corporation from pharmaceutical, medical device and biologics companies for three and one-half years from January 1, 2006 to the present."

In his July 20 response to the Committee, Sullivan voluntarily provided the financial information, while requesting that the Committee use "reasonable protection against this information becoming publicly available." Sullivan clarified, "[A]s we have discussed with your Chief of Investigations, Jack Mitchell, the business information provided is proprietary."

Later in his letter, Sullivan expressed confusion about the Senate Committee's specific interest in his private CME company:

It is a concern to us that this letter has been directed to Rockpointe as a result of a group meeting that we initiated with the Aging Committee staff. That initiative was intended to provide information, understanding and insight concerning CME and the proposed Physician Payment[s] Sunshine Act. The meeting, and the required time and preparation, constituted a good faith effort to bring relevant information to the Committee. Our intent was to differentiate accredited CME from promotional marketing. Under the credo of "no good deed goes unpunished," this initiative led directly to your singling us out among the hundreds of similar CME providers to submit confidential business records. We have expended considerable time, expense and professional fees identifying, locating, reviewing and organizing nearly 4 years of business records in order to digest and prepare the accurate summary you requested. An inquiry of his nature will likely discourage other "good Samaritans" from exercising their rights as involved citizens to bring issues of concern to the attention of the committee.

Rockpointe's financial data (and Sullivan's letter) were recently made publicly available through UCSF's Drug Industry Document Archive and reported last week by Alicia Mundy in the WSJ. It is certainly reasonable to conclude that the data were provided to the archive through the Committee (either directly or indirectly), despite Sullivan's request that the confidential information remain confidential.

But I contend that the suspected behavior of the Committee toward Sullivan's company could have been predicted by examining its powerful chief investigator, Jack Mitchell (whom Sullivan mentions in his letter).

John Howard "Jack" Mitchell (who, ironically enough, was a presenter along with Sullivan at the recent National Disclosure Summit in March) is mostly a career government staffer—although he served as an investigative reporter under syndicated columnist Jack Anderson in the late 70s/early 80s and was evidently a CNN correspondent sometime in the mid-90s. But the role that appears to have primarily informed Mitchell's "purpose" (for lack of a better word) is that of Special Assistant for Investigation in the office of FDA commissioner David Kessler. There, during the late 90s, Mitchell worked closely with Kessler on his unsuccessful effort to bring the tobacco industry under FDA control. Mitchell is specifically credited with bringing Jeffrey Wigand, the notorious industry whistleblower and tobacco insider, to the attention of Kessler.* At a symposium of the Association for Medical Ethics in March 2008 at the University of California at Irvine, Mitchell said of his FDA stint, "[T]o some respects, that was one of the best jobs I ever had."

Mitchell's work with Kessler against Big Tobacco can reasonably be expected to inform whatever righteousness he may feel when investigating other industries, including the drug and medical-device industries—which are presently in the sights of the Senate Committee on Aging. (And Mitchell's righteousness as a government reformer could only have been fortified by the recent passage of legislation that now puts tobacco under FDA control.)

However, caution is warranted in dealing with the righteous, particularly crusaders who hold powerful, non-elected government positions. Generally everything's fine if you completely agree with the crusader; however, you're no more likely to convince him that there's more than one side to an issue than you are of persuading Joel Osteen that Jesus was merely a nice Jewish boy. Moreover, if you reveal sufficient differences of opinion to a crusader, and specifically one who happens to be a senior Congressional staffer, you may find yourself the subject of a Senate Committee investigation—as Sullivan discovered.

In language that supports this contention, Mitchell himself displays an authoritarian mindset that merits caution, if not outright distrust. To illustrate, the following are excerpts from Mitchell's speech at the ethics symposium (which can also be viewed here).

When you've done the kind of work I do for so long—as an investigative reporter, a Senate investigator on 2 different occasions, and I've run government investigative offices like Dr. Kessler's—I see that frankly as part of the same thing. Just in different jobs, in different roles. When you do that, you realize that, to some degree, that whether you like it or not, whether you care to admit it to yourself or not, that there's a strong reformist streak within you. And so I tend to seek out people who are like that or see that, and I see that characteristic in them.

And so the most important thing you bring to the table when you try to do effective oversight, you try to change public policy, is you find, you ferret out the people who are capable or who have the courage to do something like that. That's how I found Dr. Jeffrey Wigand and made myself close enough to him that he was willing to come forward to the FDA.

In some cases, Mitchell's language suggests that he thinks he runs the Senate Committee on Aging and is a legislator. For instance, notice his use of "I," "my," and "we," instead of language that would more accurately refer to the Committee or Senator Kohl.

When I did a, when I began our year-long series of hearings last year on conflicts of interest and consultant payments in the medical-device and pharmaceutical industries...

And

So these are all parts of the same things the committee continues to explore as we continue our series of 5 or 6 hearings on these type of conflicts, both in the medical-device and pharmaceutical industries. And we hope to do some more hearings in the fall and into next year in support of a number of pieces of legislation. We're gonna be looking at continuing medical education. We've done a hearing on academic detailing by the pharmaceutical companies. We're going to do some hearings on free drug samples that are given to physicians and medical students and ways to combat that type of influence peddling. And we're going to do some more hearings as necessary on these continuing conflicts in order to deal with them.

And most of that is in support of some legislation you've heard about here...called the Physicians Payment[s] Sunshine Act, which is coauthored by my boss, Senator Herb Kohl of Wisconsin—who is chairman of my committee, the Senate Special Committee on Aging.

And

Now at this point, while we've negotiated this bill very closely with industry and with other parties, it's not clear to me what the fate of the bill will be for this year. We've tried to put it into the Senate Medicare package. We haven't been successful with that to date, and it doesn't appear that's going to happen. We may introduce it as a stand-alone bill with an advisement to industry...

And

One thing you may wonder, for those of you not very familiar with Congressional oversight is, the question of why would we—why would Congress be interested or why would it be any of Congress's business—the type of ethics issues that we're discussing in the medical-device and orthopedic and, as well, pharmaceutical industries. Well the reason is that my committee has jurisdiction over Medicare, and most of the medical-device companies receive a majority of their income from Medicare and Medicaid in many instances—not in all—but many. In fact, many medical-device companies receive the bulk of their income from Medicare reimbursement and Medicaid reimbursement payments. So that provides my committee, at least, with the direct jurisdiction—since we have control of the centers for Medicare and Medicaid in order to make sure and try to be vigilant that our taxpayer dollars, which go into this system—the billions of dollars—are well spent and well protected.

And

We fully intend any legislative efforts that we undertake to include all of those players, not just the large companies. And while it's pretty difficult to establish what I might call a level playing field that is our ultimate goal—we want to establish a regulatory framework that's fair to everybody and includes limits that are not unreasonable for the small companies or for the large companies. And that takes a lot of back and forth and push and shove. And I'm not sure that even the language we have in the legislation now is final or is the final answer to the problems. 

What is also concerning is that Mitchell conveys not-so-veiled threats to companies or organizations that don't cooperate with the Committee.

...[S]hould anyone block the bill's progress...we will come back next year with more oversight hearings and a much more toughly worded bill that we will be much less willing to compromise over or negotiate.

And

I must say that we invited some of the more established surgical professional associations to participate or submit written testimony to our hearing, and they declined. So hopefully, I'm hopeful they will see that the train is leaving the station, and that some of these groups really need to get on board or at least offer some comment and cooperation in terms of the legislative and other proposals which we put forward on the table.

Finally Mitchell discloses that his (or really, the) Senate Committee on Aging is not averse to going after small companies.

The large companies aren't the only players. There are a lot of entrepreneurial small companies who are out there spending a lot of money trying to influence physicians and surgeons and draw them into their sphere of influence. 

* Mitchell is featured prominently in Kessler's book about his anti-tobacco crusade, The Question of Intent.

Thumbnail image of Jack Mitchell from disclosuresummit.com.