The Slow Pace of Success in a "Do Something Congress"

by Paul D. Thacker

Perhaps no American institution is more important yet more hated than Congress. A recent poll found that Congress has a 9% favorability rating, placing it lower than cockroaches, traffic jams, and the widely loathed Canadian rock band Nickelback.

In pointing this out to the congressional staffers I’m interviewing for my project at the Edmond J. Safra Research Lab, I always ask, “Is it fair that people hate Congress?” One staffer quipped in response, “If we polled the American public, even Hitler could get three percent.”

This antipathy is based on the perception that Congress doesn’t do anything. This message gets hammered home in the media with the “Do Nothing Congress” tagline and endless stories – some true, some not – about “bickering” and “failure to come together.”

Staffers feel the same way as the public, and they’re incredibly frustrated with the impossibility of getting anything done. The slow pace of the Hill was made perfectly clear to me a few Fridays back when I got an email from a reporter telling me that the government had published the final rule on the Physician Payment Sunshine Act. While working on the Senate Finance Committee for Sen. Chuck Grassley (R-Iowa), I worked with Senate lawyers to write the first draft of the bill, and then led the investigations of corruption in the medical industry that demonstrated the need to get the bill passed.

As I was reading that email, I wondered when we had really started working on the project. I couldn’t remember. I Googled the bill, then called a reporter.

“I can’t believe it,” I said. “It was more than five years ago that I went to the Senate Legislative Counsel and sat down with them to draft the bill.”

More than five years from Senate staffers having a productive idea to the time it started to affect policy. It was an incredible amount of work.

The beginning of a five-year odyssey

The Physician Payment Sunshine Act requires companies to report to the federal government any gifts or payments worth $10 or more that they provide to physicians. This information will be available on a public website so everyone can see if a particular doctor is getting goodies from drug companies. Instead of passing as a stand alone bill, it was incorporated into the Affordable Care Act (Obamacare) to rein in the rampant corruption in the drug industry, where scandal after scandal has exposed doctors with financial conflicts of interest.

It all began back in 2007, when The New York Times reported on Anya Bailey, a teenager who was suffering horrific side effects from the drugs she was prescribed to treat her bipolar disorder. As the Times reported, the only evidence that the drug Seroquel that Anya was taking actually worked came from a flimsy study sponsored by AstraZeneca. The lead author was an academic physician — Dr. Melissa DelBello.

A few sentences in the story caught my eye and got the ball rolling. I still remember walking into the office of the committee’s Chief of Investigations and reading her this passage:

Dr. DelBello, who earns $183,500 annually from the University of Cincinnati, would not discuss how much she is paid by AstraZeneca.
“Trust me, I don’t make much,” she said.

It seemed clear to us both that Dr. DelBello was being less than honest. To figure out how right or wrong we were, we called the chairman of her department to demand the conflict of interest forms she had filed with the university. We could hear the panic in his voice when he came to the phone. Since the story had come out he had already taken multiple calls on this, he told us.

Why, he wanted to know, did we want this information on a professor in his department? “You realize that if this type of information, if it becomes public, can destroy a person’s career,” he said. He added that it might cause a “misunderstanding” and that people might think that a doctor is corrupt if they are taking money from a drug company.

“We’re worried about the same thing,” I said. “People read this and get misled by reporters and sensational journalism. That’s why we’re calling you — to figure out how much money she’s taking from the companies. That way we know all the facts and there’s no misunderstanding.”

After we got the financial information on Dr. DelBello from the university, I knew we had an issue with legs. The forms showed that Dr. DelBello was taking tens of thousands of dollars from drug companies. Before we went public I outlined what we wanted the bill to do and then met with Senate Legislative Counsel, to draft the actual language.

After I got a draft bill sent to me, I wrote a speech about what we had learned and Senator Grassley read it from the Senate Floor:

Dr. DelBello's study, which helped put Seroquel on the map, was published in 2002. That next year, she got more money than she has ever received from the pharmaceutical companies — at least that is what the documents that I have say.

In 2003, AstraZeneca alone paid her a little over $100,000 for lectures, consulting fees, travel expenses, and service on advisory boards. In 2004, AstraZeneca paid her over $80,000 for the same services.

The New York Times reported on Grassley’s speech, noting that he planned to introduce legislation to require companies to report this money they were giving to doctors. Grassley told the Times that he was simply holding doctors to the same ethical standards as elected officials who are required to report campaign donations.

A few months later, we formally introduced the bill with Sen. Herb Kohl (D-Wisc.) as a co-sponsor.

Nothing gets passed in Congress, and we had no idea if we could get this bill through. Big Pharma is a very powerful industry, and all the major players were fundamentally opposed to what we were doing. How could we get this done?

"You gotta be cynical to work on the Hill. Because it will crush you if you come in here hopeful, and thinking that change can happen. Because if change happens, it's extremely slow." (Senate Republican Staffer)

To lay the groundwork, we started talking with pharmaceutical companies, to see what they thought. In one early encounter, the vice president for a big company told us the bill would create huge expenses if it became law. As he explained it, companies provide all types of money to doctors, and these funds come out of different pots. A doctor may get taken out for dinner by a drug representative. The marketing department may pay the same doctor to give a talk. The research department may give him a grant for research. Each department is different and companies don’t maintain a central database to track how much money they give to each doctor.

“Do you want to go public with the argument that you can’t track all this money because you’re shoveling so much of it out the door to doctors?” I asked. “I’m just not sure if your shareholders would be happy to hear this.”

Still, this gave us a sense of the argument that pharma would use: the bill would create expensive regulations and drive up costs, hurting the public and potentially reducing access to lifesaving drugs.

To counter this line of attack, we launched a wide-ranging investigation into the scope of the problem. After talking to a variety of experts — people like Marcia Angell, the former editor in chief of the New England Journal of Medicine — and reporters who covered pharma, I put together a list of academic physicians seen as close to industry and who we thought were probably receiving industry money.

Sen. Grassley sent letters to these physicians’ universities asking for financial information these doctors had filed. At the same time, he sent letters to the nation’s largest pharmaceutical companies asking for a detailed list of payments they had given these same doctors.

But again, I didn’t know if this would work. So I thought of a different tactic to backstop the investigations and give us some sort of win. I didn’t want to spend months of time and have nothing to show for it. I had noticed that all these doctors were grantees of the National Institutes of Health (NIH), the federal agency that funds biomedical research. Even if we didn’t pass a bill, I reasoned, we could force the NIH to change its regulations and force doctors getting government grants to be more transparent about their ties to industry.

The big push

Things changed dramatically in 2008 with President Obama’s election. He made health care reform a top priority, and the Finance Committee was put in charge of writing the Senate version.

By the summer of 2008, I had gotten the information that we were looking for from universities and pharmaceutical companies. I wrote reports on doctors at Harvard, Emory, and Stanford who had failed to report millions of dollars in pharmaceutical money to their employers. Each report was given to the press to create maximum public pressure on the medical community to support the bill.

We also held meetings with the NIH director to pressure him for better policing of grant management. At first, agency officials tried to ignore the need for reform, arguing that they were a science agency and not an enforcement unit. We reminded them — in letter after letter — that the $30 billion Congress appropriated to the NIH belonged to the taxpayers, and that public money came with strings attached.

Heading into 2009 we detected a change in industry’s position. The media was publishing frequent stories about doctors on the take, and the old excuses weren’t panning out any longer. Pharmaceutical companies were agreeing that change was needed, and that “transparency” was right approach. NIH officials changed their tune and agreed to reform the rules for their grants.

Our sunshine language was attached to the healthcare bill working its way through Congress, and was eventually passed with the rest of the Affordable Care Act in 2010.

It was now up to the agencies to write new regulations and start to enforce the law.

We also continued to apply pressure to Obama’s NIH chief, Francis Collins, to change the NIH conflict of interest policies for their grantees. He later met with our office to discuss how to do this. After months of discussion, his team finalized its drafts and sent them to the White House for final approval. These proposed regulations would require NIH grantees to report monies they received from industry and require employing universities to post these reports online. At the last minute, the White House stripped out the reporting requirements. The watered-down version became the new standard.

The department of Health and Human Services (HHS) began promulgating different regulations for the Sunshine bill. The new law had rule-writing deadlines that the agency was failing to meet. By this time I had left Capitol Hill, but staffers for Sens. Grassley and Kohl kept working and sent several letters to the agency and the White House demanding that the regulations get done. Sen. Kohl’s staff had invested hundreds of hours of time on the bill: giving speeches to medical societies, holding multiple hearings on the Senate Committee on Aging, and taking scores of meetings with stakeholders.

A few months before Obama’s 2012 reelection, the HHS regulations were sent over to the White House for final approval. They were finally released a few weeks ago.

It took more than five years to get it done.

Now that it’s all over, I can tell you it was worth it. This bill will bring some balance back to the relationship between doctors and industry. We need them to work together — industry needs the insight from expert physicians to create the next generation of drugs and devices, and doctors need these products to save lives. But we cannot tolerate companies buying off doctors who put profit before patients.

Years from now, I think people will look back on these reforms — the Grassley/Kohl Sunshine Act — and realize that they made academic medicine better. Few people will know about the staff behind the scenes making it possible. Even fewer will truly appreciate the long hours and great deal of stress we went through.

Even when Congress gets something done, it takes an incredibly long time and years of dedication.