Docs Bemoan The EPO Controversy

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On the eve of an FDA advisory panel meeting next week, confusion and consternation seem to characterize the way some docs view the row over the benefits and risks surrounding this class of drugs, which includes Amgen’s Aranesp and Epogen, and J&J’s Procrit.

Many still use the drugs, The Wall Street Journal reports this morning, but more sparingly. Others alternate with blood transfusions, which have become safer by screening tests that reduce risk of infections like HIV and hepatitis. Some patients are refusing the meds. And a number of docs fret that the drugs are overprescribed, citing ease of reimbursement and time-saving practices such as the use of “standing orders” - instructions to give regular shots without monitoring hemoglobin.

John Glaspy, an oncologist and professor of medicine at UCLA, says that for patients with falling hemoglobin - a critical protein carried by red blood cells — doctors must face a quandary. “When we see a patient whose hemoglobin is falling, there is a theoretical risk if we do something - blood clots and possible effect on survival - and a risk if we don’t do something: transfusions and symptoms like fatigue, shortness of breath and chest pain,”

“Doctors feel concerned and unguided, because the black-box warning makes them feel vulnerable and at risk to be criticized after the fact,” he says. He adds that he doesn’t feel the drugs are commonly over-prescribed. For the record, Glaspy receives research support from Amgen and J&J’s Ortho unit.

Oncologist Stephen Hufford says that advertising of certain meds has drawn some patients to ask for drugs by name, and the drugs have been “over-marketed.” But he says the recent studies highlighting the risks are now chilling a degree of consumer demand.

The FDA advisory panel is sifting through the emerging data to address some of the confusion. Depending on the panel’s conclusions, the FDA could further refine its dosing guidelines, clarify permissible advertising promotions, and possibly even order further studies of how the drugs interacts with cancer.

The whole issue is clouded by ties some docs have to the manufacturers. For instance, the National Kidney Foundation panel that recently issued guidelines boasts nine of 16 members with financial links to Amgen. And two months ago, the Renal Physicians Association, which is funded, in part, by Amgen and J&J, urged members to be cautious about the FDA warnings.

Here’s an idealistic thought: maybe the controversy would be more easily sorted out if doctors and their professional groups weren’t so conflicted. That’s unlikely to happen. After all, money is involved. But patients ought to know if their doctors have vested interests and the source of the info their doctors are reyling on to make life-saving decisions.

A little transparency is another way to avoid kidney damage.

Full story in The Wall Street Journal (subscription required)[tags]Amgen, Aranesp, Epogen, Johnson & Johnson, Procrit[/tags]

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  1. Like many on this board I have worked for years with physicians who have ties to industry. I have been on the client side as well as on the agency/consultancy end of things and have found consistently that physicians have been consistently fair in the way they operate while under sponsorship. They have too much at stake to put at risk by leaning too heavily one way or another in favor of a sponsor. I believe that receiving sponsorhip doesn’t necessarily result in conflict and that their professional care decisions are unlikely to be unduly influenced as a result. From the outside politicians and advocacy groups may too easily assume this to be so, but from the inside it’s easier to see that such a view is a little simplistic. Just my opinion.

  2. Hi Chris,

    Thanks for writing.

    And I knew I would be told my view is simplistic. That’s why I prefaced the remark by using the word ‘idealistic.’

    I understand perfectly well the gray areas and recognize that, yes, some people may not be swayed by some sort of connection. Situations can vary dramatically and individuals will act differently.

    But in this instance, there is real controversy over guidelines and two prominent groups appear to have less than an independeat seat at the table. It’s an impression they can’t escape, even if it may seem unfair or simplistic.

    I come at this from the larger context - the increasing interest in promoting medical decisions free of influence by others whose priorities are different. At the risk of appearing simplistic, I will always argue for such an endpoint.

    And if this wasn’t such a concern these days, such reminders wouldn’t be necessary. Simplistic? Idealistic? Whatever. I stand accused. But that doesn’t mean the point shouldn’t be repeated. And no one - whether it’s a journalist or a doctor - is above being reminded.

    Hope you take this with the spirit in which it’s intended.

    Cheers

    ed

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