NY Times Article on Spine Surgery

Back pain and its cure have resisted an easy answer since humans first stood up off all fours. Spine surgery is often less than successful, and the search for artificial discs, to replace discectomy (removal) and fusion has been recently a very hot topic.

The New York Times recently reveled that the so called science that got one such artificial disc FDA approved was severely compromised by conflict of interest issues, not to mention lousy science.

It turns out, per the report, that many of the physicians who inserted the discs and then reported on their benefit had, through a clever financial pass through, potential large gains if the discs were to be approved. Do you think their opinion of whether your pain had been relieved, whether the operation was a ‘success’, an improvement over other ways of doing the same thing, might be affected by the money they stood to gain if the FDA found the device effective, based on their own reports?

Furthermore, the statistical reporting of the effectiveness of the device somehow omitted 10 percent of the patients who got it. Would you guess those were the ones who really benefited? Or the opposite. Where did they go? Do you guess that omitting 10% of the initial sample had a numerical effect on how well the device worked?

Read the Article

What Money Doesn't Buy in Healthcare

www.nytimes.com

In a packed hearing room at the Food and Drug Administration last week, a panel of cardiac experts met to consider what was obviously an important question: Has one of the most popular treatments for heart disease in fact been killing some of the patients it is meant to help?

Three years ago, doctors began using a new device called a drug-coated stent — a tiny metal tube — to keep blocked heart arteries open. It cost a lot more than an uncoated stent, but because it seemed to be far more effective, it quickly began to dominate the stent market. Last year, Johnson & Johnson and Boston Scientific together sold more than one million drug-coated stents. They have become a primary treatment for this country’s No. 1 cause of death.

In recent months, though, researchers found a disturbing pattern. People with a drug-coated stent seemed unusually vulnerable to blood clots in later years. The new stents solved one problem, but they may have created another. So the F.D.A. summoned its cardiology advisers to review the evidence.

After listening to testimony, they concluded that for healthier patients with simple forms of heart disease, the benefits of drug-coated stents appeared to outweigh the risks. The picture was less clear for people with diabetes, multiple blocked arteries or other complications. In the end, the panel concluded that doctors and patients needed to be aware of the risks and that researchers should continue collecting data. The entire affair — from the invention of the new stent to the willingness to reconsider it — was in many ways an impressive display of American medicine.

Yet it was also a nearly perfect example of what’s wrong with our health care system.

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