Cleveland Clinic watchdog doctor sees ways to improve FDA

Dr. Steven Nissen rose to national prominence as a drug-industry watchdog by exposing the diabetes drug Avandia for increasing the risk of heart attack and for sounding early warnings about the painkiller Vioxx.

The 60-year-old Nissen, chairman of the Cleveland Clinic’s department of cardiovascular medicine, is now on President-elect Barack Obama’s shortlist for U.S. Food and Drug Administration commissioner.

This Monday at the Palace Theatre in PlayhouseSquare, Nissen will appear as part of the Town Hall Series, giving a talk called “The FDA and Drug Safety: Buyer Beware.” The Plain Dealer spoke with him late last week.

This conversation has been edited and condensed.

The Plain Dealer: The FDA has repeatedly said that its $2.4 billion budget is not enough to keep pace with the $1.5 trillion in goods it regulates. And in 2007, an outside panel of experts concluded that consumers’ lives are at risk because the agency is underfunded.

Are lives at risk?

Steven Nissen: I’ve said that publicly, and I continue to feel that it would be very difficult for the FDA to do an exemplary job with its current budget. It’s fundamental to have an effective FDA because everybody’s lives depend on the kind of food they eat and what kind of drugs they take.

I think the FDA budget over the next four years would need to approximately double.

The Plain Dealer: A few of the food-chain crises the FDA has been blamed for in recent years include the E. coli-contaminated spinach grown in California, salmonella-tainted U.S.-made peanut butter and tainted pet-food ingredients from China.

Are these the fault of the agency?

Nissen: The U.S. Department of Agriculture handles about a quarter of food regulation, and the FDA handles about three-quarters. Whenever you have more than one federal agency responsible for overlapping responsibilities, there are problems.

You probably want to move the USDA responsibilities over to the FDA so that you have a single entity that’s responsible for food safety.

To improve food safety, we’ve got to have more inspections and random sampling. I have grave concerns about importation. We have to be in a position where we can protect the American public and make sure those foods are safe.

The laws need to be modernized, but also the agency [FDA needs to be modernized. It needs a transformation and it has to happen quickly.

I probably shouldn’t say this but I’m going to say it anyway: I think it’s a national security issue. We’re terribly vulnerable.

The Plain Dealer: Earlier this year, Harvard researchers found that drugs the FDA approved on deadline were more likely to cause safety problems than those cleared with more time to spare. And the FDA is now facing questions about exactly how much it knew about increased heart-attack risk of GlaxoSmithKline’s diabetes treatment before you raised concerns in 2007. Is the agency too cozy with drug companies?

Nissen: There is a problem here. The FDA has fundamentally two opposing missions. One is to promote drug development and the other one is to regulate. Somehow the FDA in the last decade or two has become much more interested in the promotion. The metric they tend to be most proud of is how many new molecular entities they have in a given year. We don’t necessarily need more drugs, we need better drugs.

I think the FDA has lost its way in terms of its mission. It is truly a failed agency. We have to change the culture.

The Plain Dealer: A report released earlier this month by the U.S. Department of Health and Human Services noted that in 42 percent of trials, the FDA failed to receive disclosure forms from the physicians conducting the trials. Are those disclosure forms important?

Nissen: Absolutely. First of all, it’s all about transparency. If one has a personal financial interest in a product, it’s very hard to be objective about that product, its safety and its efficacy.

The Plain Dealer: While you don’t accept consulting fees from drug companies, the Clinic does accept money from pharmaceutical companies for trials that you oversee. How do you ensure that doesn’t cause bias?

It’s very different level of involvement. The Clinic is a nonprofit institution. When we do a clinical trial, there is nobody profiting from that. Very few institutions and people decline consulting fees. I don’t fault people for doing that, but I chose not to. If a drug company decides to give me money, I make them pay it to charity.

If you believe that developing new therapies is good and beneficial, then you want academics [like me] to be working with this industry.

But you have to do it where you don’t personally profit from it—there are no patents involved, there’s no income involved, there’s no personal gain.

The Plain Dealer: Have you ever felt pressured by a drug company to publish results more positive than what you came across?

Nissen: All the time. When you do research with a company, they have their interest and we have our interest. The pharmaceutical industry is a for-profit enterprise. When they do research, they want that research to support their product. We have to be tough and independent.

My group will only engage in pharmaceutical trials if we name an academic steering committee that governs the trial. And the entire trial database has to be transferred to the Cleveland Clinic—not tables and figures and derived data, but the whole raw data.

We also have the independent rights to publish the results if they’re favorable or unfavorable.

The Plain Dealer: The position of FDA commissioner is one of the few top agency or Cabinet positions President-elect Barack Obama has not filled. Are your sources at the FDA and on Capitol Hill telling you why there is a delay and when can we expect an announcement?

Nissen: I think it’s a very challenging appointment. We have a failed agency that desperately needs a new direction and a very powerful industry sitting on the sidelines with lots at stake.

I am confident that the Obama administration, with a very thoughtful transition team, will do what’s right for the country. And by having a campaign which was free of lobbyists’ contributions, I’m confident that they will make an independent decision based upon what they believe is right for the country.

The Plain Dealer: What’s the one message you want the audience that comes to PlayhouseSquare to leave with?

Nissen: They need to be vigilant. They need to look out for their own interest and be informed. To not assume that because something has cleared the FDA that it’s safe and effective. To ask questions of their doctor and to demand answers.

The best advocate for anyone’s health is the patient themselves.