"…what they’ve been doing for years is buying off doctors to sell their products and a doctor’s primary obligation should be to the patient not the pharmaceutical company…"

"There’s been a blurring between science and marketing – science is supposed to be about an objective view of facts and marketing is about putting a spin."

Paul Thacker, a key staff investigator on the Senate Finance Committee, told Ed Silverman (Pharmalot) in a most interesting interview.

The Committee’s oversight investigations led to a series of hearings and reports that lifted the lid on conflicts of interest and corrupt practices by prominent academic physicians at the nation’s most prestigious academic institutions–including Harvard, Stanford, and the National Institutes of Health.

See, for example: Sen Grassley’s letters to Stanford University re unreported millions of dollars garnered by Dr. Alan Schatzberg –published in the Congressional Record:  and Stanford’s response …

and Wyeth Documents Unsealed: 
Sen. Grassley Moves to Block Ghostwriting : 
Ghostwritten reports corrupt science, undermine public health:  and

The Committee also investigated conflicts of interest at the American Psychiatric Association :
as well, the Committee uncovered the truth about the National Alliance for Mental Illness which receives millions of dollars from drug manufacturers whose extremely toxic drugs NAMI promotes. NAMI has been deceiving families and consumers about the multiple lethal risks of antipsychotics.
See: Grassley Probe: Pharma Provides 81% of NAMI Income

Unfortunately, for the public interest, Sen. Grassley will be leaving the Finance Committee and moving to the Judiciary. And Paul Thacker recently moved to Projects on Government Oversight, a non-profit. Let’s hope that others on the Finance Committee will carry on the battle to restore the integrity of medicine.

Vera Hassner Sharav

A Senate Investigator Looks Back: Thacker Speaks
Pharmalot
Posted: 20 Sep 2010 06:37 AM PDT

For the past three years, Paul Thacker was an investigator on US Senate Finance Committee, working for Iowa Republican Chuck Grassley, who is the ranking minority member. During his tenure, Thacker was central to probes into the pharmaceutical industry, specifically, the investigations into the disclosure of clinical trial data for GlaxoSmithKline’s Avandia diabetes pill and undisclosed financial conflicts of interest among academic researchers. Earlier this month, the former US Army specialist left to join a non-profit watchdog, the Project on Government Oversight <http://www.pogo.org/> . We caught him as we walked out the door to ask about his efforts and whether he thought the probes created any chance.

Pharmalot: Why leave now?
Thacker: I’ve been on the committee for three years and two years is considered a long time on the Hill and Grassley is leaving Finance at the end of this term. So he’s going to another committee looks like it’ll be judiciary….And one think that I think I understand really well is health care. I have a good understanding of science and how health care works. And being on the committee long enough you just want to do other things.

Pharmalot: But what prompted the interest specifically in the pharmaceutical industry?
Thacker: First, it was something I understood. I was a biology major in college. And I’d come out of doing environmental reporting and focusing on a lot of the same issues – conflicts of interest, and made-up research and regulation action…When I came to the Finance Committee it was little different, but not that different. In the end, the physics are the same. We have jurisdiction over four things – tax , trade , Medicare and Medicaid, and social security. Well, Medicare and Medicaid are now a bigger portion of the federal budget than defense and if you think about it, a portion of the Pentagon budget goes to healthcare. And it’s only going to increase over time…and about one-third of that is on pharmaceuticals.

So it’s a significant portion of what the federal government spends every year. It was something I could see as an important issue and a sizeable amount of money is spent on drugs. And whenever you’re working on oversight for Grassley, you try to think if can you sell this back to someone in Iowa. People understand if something corrupt is going on. They might take a drug themselves or someone in their family. It’s not something complicated – a drug that’s bad or something that’s going on with selling a drug. You’re opening paragraph is relay short.

Pharmalot: From there, though, how did you come to specific issues, such as conflicts of interest and Avandia, which you focused on quite a bit?
Thacker: With Avandia, the initial study (about cardiovascular risks) come out in The New England Journal of Medicine in 2007 and there were a lot of things in there that I understood – how scientific research works and the culture of science. I got that. I didn’t know all the details but I knew the questions to ask and what to look for. From the get go, the meta-analyss has some drawbacks, but the other thing is that it can also catch things you might be trying to hide in other trials, and suddenly it becomes clear.

So I understood both sides of that issue. So I helped design some initial questions sent out by the committee…And I ended up spending hundreds of hours going through documents and wound up writing the report and pushing that along. But you can’t go after everything. But it was a potential triggering event for the FDA, a single incident that pushed things over the edge…And pharmaceutical companies saw it the same way. I think it was a turning point for regulation, because we were able to take one issue and push it through to use as an example…On Avandia, in the last go around when we sent letter to the FDA in July, they did everyting possible to stall because they knew there was stuff in there that was bad…they pulled out all the stops.

Pharmalot: And how the focus on conflicts of interest get started and why did you seize on that?
Thacker: That was triggered by a New York Times article in the summer of 2007 that involved a woman at the University of Cincinnati and in the story there was this moment – how much money had she taken from AstraZeneca, which supported the study she had done. And she said ‘I don’t know but it’s not a lot.’ It was one of those moments. Essentially, the story was saying this woman was full of it. I walked into my boss’s office and said let’s look at this. Let’s get her forms. We called the chairman of the her department and he freaked out and he got really nervous. And we sent an email to the general counsel of the university. And Grassley went to the Senate floor and made a speech.

Meanwhile, I learned the NIH had rules on COI and we sent a letter to AstraZeneca about a bunch of doctors in Florida who were high prescribers, and nothing was really there. I couldn’t find a pattern but found a ton of money going to this one professor, Delbello, and it was different from what the company was saying. So we made a chart…and it caused a panic in the university. You know, once you start to talk about peoples’ money and federal funding, they start to freak out and for good reason, because they know it could be shut off. The pharmaceutical industry knows what they’re doing. They’re cultivating these docors. We saw the emails. Some of these doctors are so big the pharmaceutical companies actually fear them because they can move market share. It’s a relationship and we told these companies that if they know some doctors trying to strong arm them, let us know. It goes both ways. Look at it this way – we weren’t going after the Soviet Union, we were going after Afghanistan. We were going after proxy states and the doctors were proxy warriors. And when it comes down to it, they’ll throw the doctors under the bus.

Pharmalot: In the process, you made your boss one of pharma’s least favorite people.
Thacker: Look, what they’ve been doing for years is buying off doctors to sell their products and a doctor’s primary obligation should be to the patient not the pharmaceutical company…and it’s making them uncomfortable. But I don’t think we ever did anything that was unfair. When we first started, we had debates about the Physician Sunshine Payment Act and one executive from a large company was in the office and this guy was saying how can we do that? It’s expensive trying to track down the money. So we asked if you’re going to go back to your investors and say you have no clue where you’re spending your money. Now, they’re all behind transparency and so there’s an evolution in thinking. Now they’re all lining up and saying it’s the fair and honest thing.

What’s gone on with the pharmaceutical industry is a physician arms race to buy off doctors, but if you cause some sort of detente, you remove that weapon from the arsenal of all the companies and they’ll all save money…There’s been a blurring between science and marketing – science is supposed to be about an objective view of facts and marketing is about putting a spin. That’s been what I’ve been going after- to point out that is what they’re saying about the best set of fact was not always science. And if one company does it, another is forced to do it. And it’s a behavior that’s become normalized, so when you question it people think you’re being unfair.

Pharmalot: What was your favorite moment?
Thacker: The tightest case we ever had was on Charles Nemeroff (see here <http://www.pharmalot.com/2010/06/and-the-status-of-the-nemeroff-probe-is/> ). There was so much documentation where not only did we show that he had not reported income but that he had made statements to the university that were false to his superiors. There was one point when he wrote a letter when he wrote that I hadn’t done this or won’t do that, but he did. It was such an airtight case.

Pharmalot: So should your targets expect less pressure going forward?
Thacker: One of the things that may happen is some of the pressure will come off, but there’s been a sea change in thinking about some of these issues. The old chestnuts about there not being a problem – I don’t think people don’t believe that anymore. Those arguments don’t work anymore. The NIH, universities…these are institutions being run by grown people and there comes a time when training wheels have to come off and they have to understand there’s corruption in medicine and science. Part of the problem is we had a generation of people who didn’t understood there was a problem. But a lot of people in the younger generation know that what’s going on is wrong. We’ve got a guy at FDA who is now deputy commissioner and he knows it’s wrong and he reported the use of textbooks provided by pharmaceutical companies when he was in med school The problem is there’s no clear delineation to say when it’s wrong. We’ve passed so far over the line and need to shift things back in the other direction.

Pharmalot: Other than the J&J hearings (see this <http://www.pharmalot.com/2010/09/congress-to-hold-another-jj-recall-hearing/> ), there seems to be a shift away from focusing on pharma. What do you foresee?
Thacker: Well, remember that (Henry) Waxman (who now chairs the House Committee on Energy and Commerce) went from doing oversight to a committee that can actually draft legislation. But he’s been preoccupied with heatlh care reform and climate change and energy legislation. The next thing they’re going to do is climate change. Maybe after that they’ll shift their gaze back to the (pharmaceutical) companies. We’re now in the second half of Obama’s term and maybe if there’s a Republican take over in Congress and Waxman Is unable to draft legislation, they may do more oversight.

The problem with oversight is that everyone who comes to Washington come here to be liked. They’re all about increasing the size of their Rolodex and getting to know more people, but when you do oversight, because people start to dislike you. And so very few have the stomach to do oversight. As soon as you start asking questions and start pointing things out, you start alienating people. With oversight, you can be one individual and create change. In the Senate, to pass legislation, you need at least 51 people behind you to do something. And now with the gridlock, you need 60. But with oversight, you can force change in an agency or companies as one person. And people forget its written in the Constitution to do the job of oversight, but no one wants to do it because it pisses people off. The culture is to have people like you, rather than respect you for doing a good job.

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