Avandia Scare Continues to Raise Concerns

Recent news that Avandia may increase the risk of heart problems continues to cause widespread concern. The drug is commonly used to treat diabetes by helping to lower blood sugar. Dr. Carol Horowitz and author Harriet Washington, a bioethicist, discuss the disturbing findings and how it impacts the more than 20 million Americans with diabetes.

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MICHEL MARTIN, host:

I'm Michel Martin, and this is TELL ME MORE from NPR News.

Later in the broadcast, in the wake of anti-war activist Cindy Sheehan's decision to step aside, other mothers of soldiers killed in the Iraq war talk about why they are still fighting to stop the war.

But first, more than 20 million people have diabetes in the U.S. That's a key reason the news that Avandia - a drug to help lower the blood sugar - may increase the risk of heart problems has caused such widespread concern. GlaxoSmithKline, the company that makes Avandia, continues to defend the safety of the drug. Still, critics are concerned about the implications for everyone with the disease, but especially for some high-risk populations.

I'm joined by Doctor Carol Horowitz. She is the assistant professor of health policy in medicine at the Mt. Sinai School of Medicine. She is also the head of the East Harlem Diabetes Center of Excellence. She joins us from our New York bureau. We're also joined by Harriet Washington. She is a bioethicist and the author of "Medical Apartheid". She joins us from her home office in New York. Welcome to you both.

Dr. CAROL HOROWITZ (Assistant Professor of Health Policy in Medicine, Mt. Sinai School of Medicine): It's good to be here. Thank you.

Dr. HARRIET WASHINGTON (Bioethicist; Author, "Medical Apartheid"): Thank you. It's my pleasure.

MARTIN: Let's begin with you, Doctor Horowitz. What does Avandia do for you if you have diabetes, and is it popular?

Dr. HOROWITZ: Avandia is very popular. With diabetes, there can be one of two problems: either people can make too little insulin, or their bodies might not be sensitive to insulin - sensitive enough. Avandia is part of a class of medicines that help make the body more sensitive to insulin, and that's how it works to lower blood sugar.

MARTIN: Now, as we've discussed, diabetes disproportionately affects racial minorities, but these are also groups that are less likely to have access to routine health care. So do you have any particular concerns? I know you practice in East Harlem, which is a heavily minority area. Do you have particular concerns about how your patients are reacting to this news?

Dr. HOROWITZ: I do have particular concerns. Not only are people of color more likely to have diabetes, more likely to die from diabetes and more is likely to have poor access to health care, in addition, people of color are less likely to trust their doctors or the health care system. So when something like this happens and a drug that's really commonly used to lower sugars is found to be possibly not as helpful as other medicines and possibly unhelpful or harmful, people may stop the drug without speaking with their provider, first of all.

And second of all, people of color who may have rightly retained a very healthy skepticism of health care might look at this as here's a drug that's harmful to me, so what am I going to do? My doctor convinced me to take this medicine, and it looks like that it doesn't even help me. It might even be bad for me. So what am I going to do? Go back to that same doctor and get a different prescription? Maybe this isn't the right game for me to be in. And I have great concern about that.

MARTIN: And are you getting pushback from patients saying what do you got me on, doc?

Dr. HOROWITZ: We are getting pushback in a couple of ways. One is we're finding that when we reach out to people who we know are on Avandia, they say, oh, I already stopped it and I wasn't going to call you. I figured I'd come in to see you later, or I really have to think about what I'm going to do about my diabetes if the drugs you're giving me aren't safe.

MARTIN: What are you telling them to do?

Dr. HOROWITZ: Fortunately, there are other medications that are safe to use for people with diabetes. So we can recommend other drugs that people have been using for much longer and have much better safety records, including cousins of Avandia's that looks like it doesn't have the promise that Avandia does. And hopefully, if we have good relationships with our patients and trusting relationships, we can work this out.

MARTIN: Harriet Washington, let's turn to you. And I think it's important to reemphasize right now that Avandia has not been taken from the market. But this is one of a number of recent announcements about a drug already on the market, and then subsequent findings indicate that there's a problem. Why do you think this is? I mean, do you think that drugs have been rushed to the market or this just the price we pay for wanting an array of new treatments as soon as possible?

Dr. WASHINGTON: Side effects are a component or a factor of almost every drug -including new drugs. However, it is quite troubling that we have been seeing a long string of medications that are brought to market, have warnings issued about them by prominent scientists, warnings that are ignored by the FDA and are later pulled from the market when the subject of those warnings manifest themselves. This is exactly what's happened with this drug. And it's exactly what happened with the drug that Avandia was put on the market to replace. Avandia was touted as replacement for Rezulin, which was manufactured by another company and withdrawn from the market when it caused liver problems.

There were warnings issued by it - by many prominent scientists, I think most notably by Dr. John Buse, who's the new head of the American Diabetes Association. He warned, and several other scientists warned years ago in 2001 that there was a higher level of heart problems than GlaxoSmithKline was indicating. And this points to two fundamental problems: the question of whether drugs are indeed being rushed to the market, and also why it is pharmaceutical companies are able to control the amount of information released about a drug's side effects. Pharmaceutical companies have repeatedly hidden adverse effects of drugs. This is a serious ethical and medical problem.

MARTIN: Harriet Washington, you've written about the history of race as a factor in using questionable treatments for patients or using questionable ethical practices in evaluating treatments and scientific research. And you've heard Dr. Horowitz discussed her concern about how that legacy of mistrust between minority communities and the medical community can have an impact. Do you think that that legacy of mistrust has been abating over the years?

Dr. WASHINGTON: It's difficult to tell, because there have not been good enough studies performed. Unfortunately, up until about three or four years ago, most of the studies focused upon one single instance of researcher abuse - Tuskegee syphilis study. That was a very important study historically and ethically, but it pales compared to the many, many studies I detail in my book. So until we have more open-ended studies, we're not going to know the real effects. We do know that African-Americans are much more likely to fear the medical system and are especially loath to engage in clinical trials, including therapeutic trials, which African-Americans should be participating in larger numbers.

MARTIN: That raises an interesting question, Doctor Horowitz, is that if there is this legacy of mistrust and you've got communities that are disproportionately affected by a disease like diabetes, you would assume that members of that population ought to be the very people who ought to be in clinical trials when a new drug is being tested, right? So then the question is then does it become harder to get members of minority groups to participate in these trials?

Dr. HOROWITZ: In my opinion, it's harder because we're probably not doing it right. Most of research that's done is done from the point of view of academics and researchers controlling the ideas, the information, having all the funding and making the decisions. People go out to communities of color and say, please come and join the research study. I think newer research is going to work on ways that we actively, equally and respectfully partner with people who are disproportionately affected by diseases, so they are part of developing a solution and implementing them. And hopefully in that way, we will change the dynamics of research and people will be more interested in participating.

MARTIN: What do you think should happen now, Doctor Horowitz? What are you advising your patients to do, and what other steps would you like to see taken either by the FDA or by - introduced by the drug company now going forward?

Dr. HOROWITZ: I think the most important thing for people who are on Avandia is to contact their health providers and work with their health provider to make a decision about what is the best thing for them. In terms of health providers -when we look at diabetes, we certainly want treatments that lower blood sugar. But the number one killer of people with diabetes is heart disease, and it's not enough to have people with better lab tests, lower sugars. We need treatments that help people live longer and healthier lives.

And I think what's going on with Avandia is a real challenge to doctors, that we need to think carefully about why we give medicines to patients. So are we just doing it to lower blood sugar? No. Well, we should look back on these studies and if that's all we do, find a medicine that does more. So this is a challenge to doctors. It's also a challenge for policymakers, because more than 50 percent of the FDA's budget comes from drug companies. And we need to find a way to start better FDA reform so that doctors like me can look at drugs that are approved and have some comfort that they're really going to help our patients.

MARTIN: And just finally, on this question of access, one of the things you've emphasized in our conversation is that people need to be talking to their health care provider and not make decisions on their own. What about people who don't have a strong relationship with an individual provider? You know, they're going to - you know, no disrespect to anybody - you know, they're going to a clinic. They don't have a, sort of, a bond with an individual provider. What should they do?

Dr. HOROWITZ: Well, I'm hoping that people like the patients I see in the clinic do have a bond with their providers, and that people can have just as good care. But I still think people need to reach out to their health providers, because that's ultimately who gives out prescriptions to help control blood sugars. People can try reading about it and people can listen to media about it, but the most important thing is for someone to sit with them and say this is your blood sugar. These are the medicines you are taking. This is your risks for having poor health and good health, and this is what you need to do. And I'm not sure where people can go other than health providers for the information at this point.

MARTIN: Harriet Washington, what would you like to see happen now in the wake of this latest concern about this drug?

Dr. WASHINGTON: We need to have greater transparency so that pharmaceutical companies have less control over some aspects of the conduct of clinical trials, and certainly so that they are no longer able to hide this sort of data. I think we have to remember that although this is a new warning from a physician who looked at data, the string of warnings stretching back to 2000 from other physicians who've been repeatedly pointing out that the heart risks were higher than GlaxoSmithKline was claiming, and that the FDA was relying too heavily on the GlaxoSmithKline's claim.

So we need to have that kind of transparency and accountability from pharmaceutical companies. We also, I think, need to look at this tendency of allowing me - two drugs, very similar drugs, to be quickly brought to the market.

MARTIN: And given this legacy of mistrust - particularly between the medical and scientific community and particular, sort of, minority community - do you feel that that enhanced transparency and openness would do something to correct that legacy of mistrust?

Dr. WASHINGTON: It is essential for correcting that legacy. It is absolutely essential. It's the reason why I wrote my book "Medical Apartheid", because a lot of this history has been shrouded. People know of it, and the myths unfortunately are even more dramatic than things that have actually happened. So when we begin this openness and revealing to African-Americans and to other Americans precisely what is happening, that's going to enable better communication. And that's - and you know, it's essential. It's very, very important.

I also want to note, African-Americans are more likely to use an emergency department for their primary health care provider. That behavior has to stop. It's very dangerous.

MARTIN: Harriet Washington is the author of "Medical Apartheid". She joined us from her home office in New York. And Dr. Carol Horowitz is an assistant professor of medicine at the Mount Sinai School of Medicine. She heads the East Harlem Diabetes Center of Excellence. Dr. Horowitz joined us from NPR's New York bureau. Thank you both so much for joining us.

Dr. WASHINGTON: Thank you.

Dr. HOROWITZ: Thank you.

MARTIN: On Wednesday, the company that makes Avandia, GlaxoSmithKline, published a letter in the British medical journal The Lancet that reaffirmed that companies' confidence in the safety of the drug, saying the drug use and approval system is working. You can read the entire letter on our Web site, npr.org/tellmemore.

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MARTIN: Just ahead, a South African anti-apartheid activist has a new cause - fighting street crime.

Dr. XOLELA MANGCU (Former Anti-Apartheid Activist; Columnist, Business Day): You know, I do not want to speak about it because I did not want to seem like I'm feeding into the stereotype, the racist stereotype of a country that is run by black people and is therefore falling apart.

MARTIN: That's coming up next on TELL ME MORE.

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MARTIN: I'm Michel Martin. The conversation continues at TELL ME MORE from NPR News.

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