Salesman of the year
Would you allow a salesman for a medical device company to cut you open and insert an artificial hip?
No?
Then you should think twice before you let a doctor do the same thing. Because your doctor just might be the device company’s best salesman.
Questioning commitment
Katherine Korgaokar’s harrowing personal story is so compelling that she recently shared it with the U.S. Senate Special Committee on Aging. The committee is investigating the FDA’s absurdly lax approval process of high-risk medical devices.
Katherine told the committee, “I am concerned that the doctors who are actually installing these medical devices may not be fully committed to the wellbeing of their patients.”
Turns out, that’s putting it mildly.
Last year, Johnson & Johnson’s DePuy subsidiary recalled 96,000 prosthetic hips. Before the recall, these metal-on-metal hips were considered “state-of-the-art” – specifically designed for young active people like Katherine Korgaokar.
Katherine explained to the Senate committee that she was born with a condition that caused premature deterioration of bones in her hip joint. She was in enough pain by the time she reached her 30s that she was ready for a full hip replacement.
Her doctor told her the DePuy hip was a new, superior design that would function well for at least 20 years, maybe more.
Katherine was sold. She went ahead with the surgery, which she describes as a “huge success.”
Katherine: “Within three months of the surgery I was essentially pain free and was able to engage in activities that had previously been off limits. The surgery truly changed my life.”
And that would be a perfect spot for this story to end. If only!
Dishwashers and cars
Just four years after her hip replacement, Katherine received a letter from her surgeon informing her that her prosthetic hip had been recalled.
Katherine: “I really didn’t understand the implications of what I was being told. In my mind, recalls were for dishwashers and cars; not body parts.”
A blood test revealed that Katherine had excessive levels of cobalt and chromium – about 1,000 percent higher than normal. Excessive wear and tear of the components of the hip had released this metal debris into her body.
Suddenly, huge health concerns loomed. High levels of cobalt and chromium have been linked to increased risk of cancer, heart muscle deterioration, and harm to a fetus. As it happened, Katherine and her husband were planning to start a family at that time.
But a family would have to wait. Katherine had a second hip replacement, which was substantially more difficult and painful than the first.
Katherine: “I am told that undergoing a hip revision surgery so soon after my first surgery, will likely result in me experiencing more pain, dislocations, and other problems down the road. This is because each operation affects the muscles, tendons, and bones in the hip and makes the hip less stable.”
After expressing her dismay about FDA fast-tracking of devices with “little or no testing,” Katherine arrived at the most outrageous part of her testimony…
“I recently learned that the surgeon who recommended that I have the DePuy ASR installed in my body had actually received more than $600,000 from DePuy in ‘consulting income.’ This was never disclosed to me before my surgery. Although I would like to think these payments had no influence on my doctor’s decision to use the ASR, I will always have doubts.”
I have no idea if Congress is really going to put the screws to the FDA and overhaul the absurdly dysfunctional and industry-friendly medical device approval system. You could say I have my doubts…about $600,000 worth – and then some. (Why the doubts? Read about them here.)
Meanwhile, for patients like you and me, there’s an important insight to be learned from Katherine’s story.
Consider those 96,000 prosthetic hips recalled by DePuy. The chance that Katherine’s surgeon was the only one who received generous consulting fees is very unlikely. It’s a sad thing, but you can never assume that your doctor is fully committed to your wellbeing over the financial wellbeing of a drug company or a device-maker.
What can we do? It’s all we can do: just ask. When your doctor recommends a drug or a device or a procedure, ask if he has any professional connection or if he benefits financially in any way. I realize it’s awkward, and that you may get an honest answer and you may not. But if your doctor is offended by the question, that just might be your answer.
Sources:
“FDA Slammed for Device Review Procedures” Ed Silverman, Pharmalot, 4/13/11, pharmalot.com
“Testimony of Katherine Korgaokar” U.S. Senate Special Committee on Aging, 4/13/11, aging.senate.gov
