NEW DIRECTION FOR ENERGY INDEPENDENCE, NATIONAL SECURITY, AND CONSUMER PROTECTION ACT AND THE RENEWABLE ENERGY AND ENERGY CONSERVATION TAX ACT OF 2007--MOTION TO PROCEED -- (Senate - April 02, 2008)
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Mr. GRASSLEY. Mr. President, I have had the opportunity in the last several years that I have been in the Senate to look into how drug companies may be improperly influencing medical care. It is no secret that drug and device companies have substantial financial relationships with the health industry and specifically with physicians.
In addition to multimillion dollar royalty payments and lucrative consulting contracts, I found that drug and device companies often provide perks to doctors. These would include things such as expensive trips, lavish speaking fees, and other benefits that are too numerous to mention at this point.
These relationships, as you might expect, can motivate doctors to modify their treatment practices. It can motivate doctors to do practices that may not be in the best interests of the patient.
Because these financial relationships are so common, I have had the help of Senator Kohl of Wisconsin in the introduction of a bipartisan bill called the Physicians Payment Sunshine Act. We introduced that in the latter half of last year.
Now, this bill is not aimed at stopping money flowing to the doctors, the results of which I have spoken about. But it ought to throw a little sunshine on this issue. And that sunshine on this issue will go a long way toward curbing bad behavior.
I am proud to report the bill is gaining support from industry and from many physicians. In fact, medical device maker Zimmer recently announced their support. I expect even more companies to come onboard very soon.
You might say that these companies coming on board must like this, that it is not going to do any good. Well, it will do a lot of good. I think companies coming on board at this point are recognizing that if they are in a public debate on this issue where there is evidence that their payments to doctors may influence practice, that is not going to stand up in the theater of public debate, and so they ought to help their public relations and get behind this legislation. They know it is the right thing to do. I hope my colleagues in the Senate will look at this bill and see it as the right thing to do as well.
Since last summer, I have been investigating dozens of physicians to see if they are reporting their outside income to universities they are affiliated with. These physicians are at public as well as private universities and are working at institutions of higher learning across the United States today.
I am going to report on the action of one physician. I do this to explain how industry payments to medical experts can affect medical practice. Last summer, the New York Times ran an article about several drugs called atypical antipsychotics. These drugs are very powerful. The New York Times reported they are widely prescribed for children.
In the case of Seroquel, this drug became widely prescribed to treat children for bipolar disorder in the year 2005. It is important to examine this drug because we have paid billions of taxpayers dollars for Seroquel in the last years under various programs that the Federal Government has that provide help for people who cannot otherwise afford it.
Now, this happened after a group of experts decided that drugs such as Seroquel worked in kids and then published new guidelines in the Journal of the American Academy of Child and Adolescent Psychiatry.
But this panel based its guidelines on a single inconclusive study that was done in the year 2002, paid for by AstraZeneca. The study concluded kids did well on Seroquel, even though half of them dropped out of the study because of bad side effects.
The lead author of this study was Dr. Melissa DelBello, a professor at the University of Cincinnati. After reading about this story, I sent a letter to the University of Cincinnati and asked to see Dr. DelBello's reports on outside income.
I found out Dr. DelBello received over $100,000 from AstraZeneca in 2003, the year after she did this study. The following year, the company paid her over $80,000. These payments were for things such as lectures, consulting fees, services on advisory boards, and reimbursement for travel-related costs.
After the university sent me these records, I then asked AstraZeneca to account for money the company had sent to Dr. DelBello. The numbers after they all came in simply did not add up.
Between 2005 and 2007, Dr. DelBello reported about $100,000 in outside income to her university. But I found out AstraZeneca had paid her over $238,000, and obviously $138,000 of reported income is a big difference. Of course, I am finding out the money keeps trickling in. Last week, AstraZeneca reported to me they had discovered an additional $1,800 in payment to Dr. DelBello, and who knows if we will ever know the full accounting of this money paid between AstraZeneca and the professor.
So her own university, her very own university which is supposed to be monitoring her conflicts of interest, did not even know about these additional payments. It seems to me they did what many universities around the country do: They trusted their faculty to provide accurate information.
Even worse, I found out Dr. DelBello received grant money from the National Institutes of Health. According to Federal regulations, universities are supposed to monitor conflicts of interest when their researchers receive National Institutes of Health grants. Obviously, the university has engaged in the practice of trust but did not verify, where the rule is: Trust but verify.
Another interesting thing happened while I was looking into Dr. DelBello. According to the letter I received from the University of Cincinnati, Dr. DelBello failed to report other money she also received from big drug companies.
So it turns out Dr. DelBello has a company which she established for ``personal financial purposes.'' AstraZeneca was involved here. Let me remind you that AstraZeneca is the maker of Seroquel. They paid MSZ Associates, Inc., an Ohio corporation, over $60,000.
Where do you think the address of MSZ Associates is? Well, you probably have figured it out, the Department of Psychiatry, University of Cincinnati.
This situation is unfortunate on so many levels. It is unfortunate for the University of Cincinnati relying on the representations of its faculty, it is unfortunate for patients who once believed their doctors were not for sale, and it is unfortunate we are in a day and an age where a bill promoting transparency for millions and millions of dollars going from big drug companies to American doctors is necessary.
In other words, I am saying to my colleagues in the Senate: The bill Senator Kohl and I put in last year that is picking up steam, even from companies in the medical business, should not have had to be introduced. The checks and balances that are out there between universities, between the NIH and universities that get their grants ought to be enough to make sure the ethics are properly followed.
This information is available, and, most importantly, the information is public, because this is the public's business. The public has a right to know whether people who doctor them might have a financial interest in the treatment that is prescribed for them.
Now, I have given you one example of a doctor who has been receiving large amounts of money from drug companies. In this area, as in many others, I hope a little bit of sunshine will go a long way. That is what the Kohl-Grassley legislation is all about. The fact that a physician can promote a drug to other doctors and receive NIH funding, while hiding a very clear conflict of interest, ought to be very disturbing to all of us.
That is why this bill is very needed. Because nobody is watching this money, and it is having a bad effect on medical practice as evidenced by this drug made by AstraZeneca.
Before closing, I wish to give this compliment to the University of Cincinnati. This university has and continues to be very cooperative in this investigation. I very much appreciate this. Thank you to the University of Cincinnati.
I yield the floor.
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