In the wake of the recent Medtronics scandal, back surgery and medical ethics have come under public scrutiny.
For those unfamiliar with the controversy, spine research experts, paid by Medtronics, are accused of allegedly overstating the benefits of Medtronics’ Infuse, a bone morphogenetic protein (BMP-2) used in spinal fusions, and failing to report certain risk factors.
Tracy Weber and Charles Ornstein, writing for the Los Angeles Times, put forth some thought provoking questions related to medical ethics.
Your doctor gives you an expensive new drug to control your cholesterol, or recommends a certain brand of artificial hip, or says you need a stent to open a clogged artery.
He’s the expert. But how do you know his expertise is untainted? The makers of the drug, the replacement hip or the stent may have paid your doctor to deliver promotional talks extolling the virtues of the product. Or they could be paying him, or her, to consult on marketing plans. It doesn’t necessarily follow, of course, that this kind of moonlighting influences the treatment you receive. And many doctors don’t accept these kinds of payments. But if yours does, wouldn’t you like to know that?
As it stands, doctors don’t have to tell you if they’re working with the makers of the products they’re prescribing you. They don’t have to tell you whether they own stock in those companies or do research on their behalf.
There’s no place for you — the patient — to find out whether your doctor is prescribing more drugs or medical devices made by companies with whom he has a relationship.
Understanding such ties can be important. Many brand-name drugs are wildly expensive, and some carry an array of dangerous side effects. Sometimes similar drugs, either those made by competitors or generics, are cheaper or have fewer risks.
Patients largely trust their doctors to do what’s right for them. But a recent string of scandals has raised questions about whether patients need to know more. Pharmaceutical and medical device makers have paid billions of dollars to settle accusations of kickbacks to doctors and improper marketing of their products.
Many physicians say the close ties between drug and device firms and doctors lead to new and more effective medications, life-saving innovations and a better-educated profession. Although this is certainly true, the relationships also can cause physicians to — consciously or not — downplay side effects and poor research outcomes, studies show.
Earlier this summer, for example, the Spine Journal devoted an entire issue to repudiating the research of several spine experts that supported the widespread use of a Medtronic bone growth product used in spinal fusions. The articles charged that the researchers, who had substantial financial ties to Medtronic, overstated the benefits of the product, Infuse, and ignored its risks.
Only recently have some tools become available to help patients learn about their doctors’ financial ties before they are in the exam room.
Several companies, pressured by Congress or required by legal settlements, have started to reveal the names of the doctors they’ve paid to deliver promotional talks or serve as consultants.
By 2013, every drug and device company operating in the United States will have to do the same, under the healthcare reform law passed last year. They’ll also have to say if they’ve paid doctors for consulting, research, even a dinner.
We’ve looked at the data from 12 companies, which make up 40% of U.S. drug sales, and found some surprises among pharma’s favored speakers and consultants.
Many of the doctors who received the most money hadn’t published much in the way of research, and many didn’t have associations with academic medical centers. Some had no credentials beyond a medical license. And some had been sanctioned for misconduct by their home state medical boards.
Among the top-paid speakers from that sampling was Santa Monica pain physician Gerald Sacks. Since 2009, he has earned at least $522,113 giving promotional talks and consulting for four companies, according to the data.
Sacks, an anesthesiologist, isn’t a leader in prominent pain medicine societies, and several top pain physicians told us they hadn’t heard of him. He doesn’t work in an academic medical center such as UCLA or USC. He hasn’t published much research. We tried to talk to him about what he was paid for, but he didn’t return numerous messages.
Sacks’ slides from a 2008 educational talk and 2009 presentation before the U.S. Food and Drug Administration describe him as the director of pain management at St. John’s Health Center in Santa Monica. A hospital spokesman said Sacks has never held that title and that his pain clinic is not part of the hospital. He does have the ability to admit and treat patients at St. John’s.
Drug firms have a pretty fair idea of whether their investment in doctors like Sacks pays off. They pay millions to researchers who buy data from pharmacies and track the prescribing habits of doctors. Pfizer, which gave Sacks at least $318,250 for speaking in 2009 and 2010, according to its data, could find out if and how often he gave patients Lyrica and Celebrex, two of the company’s pain medications. Firms can also track whether and how often the people who attended such talks prescribed the drugs that were discussed.
But not everyone who would like to examine the data is allowed to. The middlemen who collect this information refused to sell the data to us.
We’d love to hear your thoughts about back surgery and medical ethics? Leave a comment below and let us know if you have a problem with medical experts ordering procedures or medications where they have a financial interest.
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