MammoSite

“Nobody is looking to see whether they help patients."
- Diane C. Robertson

In Baltimore in the 1890s a new kind of treatment was introduced for breast cancer: radical mastectomy. This procedure removes the breast, the chest muscles under it including the pectoralis major and the pectoralis minor, and the lymph nodes of the axilla. For the next 90 years this was the treatment recommended to 90% of the women treated for breast cancer in the USA. About 500,000 women had this treatment before someone bothered to do the science to figure out that it was no more effective than non-radical surgery.

Now comes MammoSite

The Food and Drug Administration cleared MammoSite for use on breast cancer patients in 2002 making it one of the thousands of devices the FDA lets onto the market each year after only cursory review and with no clear evidence that they help patients. By 2008 MammoSite had been performed on about 45,000 breast cancer patients in the USA. But even after treating 45,000 patients with it, there still had been no collection of information on those patients that would enable the health care system to learn whether MammoSite is better or worse than other treatments available for the same condition.

Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pennsylvania that evaluates new devices for insurers and hospitals, said “Nobody is looking to see whether they help patients," and “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”  (New York Times, October 27, 2008)

You can be sure that the people providing the treatment looked to see if they were going to make a profit with it. And you can be sure that they learned what is necessary to limit their liability for treating patients with it. But the well-being of these providers does not depend on whether the treatment actually is the best one for patients. So they don't look into that.

It is the same with the mammography (see the link) that is used to determine whether the patients need treatment in the first place. How long will we have to wait before someone does the science on MammoSite? Another 90 years? Another 500,000 patients?

Trusting the Blind to Lead the Blind

Top insurance executive Ronald A Williams was the insurance industry's emissary to the White House when the new health care bill was being argued. Years ago his mother was diagnosed with breast cancer. He witnessed how hard it was for her, even with good insurance, to find appropriate care. He still is unsure whether she got the best care she could have. How can patients figure it out when no one records the information needed for anyone to figure it out? Even the providers patients trust with their lives don't know.

(By the way, even he knows the new health care bill isn't going to lower costs. I say "even" because that appears to be a lonely position at the top.)

Devices

It is the same throughout medicine. Take, for instance, devices like artificial knees or hips, a 6.7 billion dollar per year business in the USA. There are no independent referees or sources of information about them. No one tracks the long-term performance of them. The Food and Drug Administration clears them for sale without their being tested in patients, and then after they are installed in patients, no one looks to see how they are doing.

One patient, Lise Markham, had to replace a flawed hip two years after it was implanted. The experience awakened her to how little patients know. "My doctor knew everything about me . . . but what did I know about the other side?" she said.

Dr. Richard A Berger received over $8 million over a decade for consulting and training other surgeons in how to implant artificial knees and other medical devices. Finally he began to notice how often patients were having problems with them. He did his own study and found that half of all patients had problems with the artificial knees. As a result he no longer gets to be a consultant or a trainer of surgeons. Someone else is training surgeons in how to install the devices that cause problems half of the time without anyone monitoring that or enabling patients to shop around to see if other devices might be a safer option.  

MSRA Study

In response to years of heavy lobbying and politicking by a victim of MRSA, The Illinois Hospital Association finally conducted research on patient-discharge data ― the same kind of analysis that previously had been done by The Seattle Times in Washington state, which one might think should have been a harbinger to which someone in medicine should have been paying attention ― and was stunned at how many MRSA cases it found. Medicine keeps telling us that our well-being is their foremost concern. If it actually were, wouldn't they check to see how they were doing in achieving it? The health care industry is not interested in knowing their own success rates. And they don't want patients to know it either. So safety is the issue that it is (see Conflict of Interest).

The Centers for Disease Control and Prevention found that MRSA now kills more people than AIDS. A medical panel said that screening all patients for MRSA would be "impractical or extreme ... with little added value." According to the CDC, 99,000 patients die from MRSA each year. To people earning their livings delivering health care, saving the lives of 99,000 patients is of little added value.

A couple of versions of the accident pyramid say that for every fatality 300,000 unsafe acts were committed and 29 other people were injured. In other words, for each of those 99,000 who died there are 29 who got sick and lived. That is 2,871,000 patients, some of whom were disabled, and others of whom are functional but miserable for the rest of their lives. Including the ones who died, it is close to 3 million people who never will be the same because they were made sick unnecessarily by unsafe acts committed by caregivers. But saving them would create little added value to the people earning livings caring for those patients.

What makes it impractical and "with little added value" is that caregivers don't make money by saving lives. Just as they don't make more money by checking to see if half of artificial knees fail. They make more money when artificial knees fail and patients come back to get another knee. They make more money when time isn't wasted on extreme measures like washing hands and taking other safety precautions to avoid infecting patients. They make more money treating the infections they give patients than they would if they protected the patients from getting infected in the first place. They make more money when they make patients sicker.

That could change if patients were able to learn what people, institutions and practices cause the most infections. Then patients could go someplace safer and the more dangerous practitioners would have to stop infecting patients in order to win business back.

Diabetes Study

We know a woman whose dissertation for her Masters of Public Health was a study on a diabetes clinic. She was looking to see how much good the clinic did for the patients. Unfortunately, in the end all that could be said was that the results were inconclusive. It was said that the patient-information collected at the clinic was good, but not was good enough for a research project.

I'm not sure why, at every level, we give them so much credit for being selfless and well-meaning and objective and knowledgeable about their patients. No attention is paid to the how much caregivers need to believe that they are doing good, and how much they are willing to ignore in order to rationalize the belief that they are.

If they had as strong a need to actually do good as they have to believe that they do good, they already would know what the long-term consequences are for their patients. But they don't. They don't collect the data that would enable them or anyone else to make an honest evaluation of the long-term results of their care on patients. Anecdotal evidence remembered by people with strong self-interests describes one reason why healthcare professionals running state medical boards are unworthy police of their own colleagues, let alone of themselves. It is why healthcare professionals imagine they are helping patients when they put risk management in charge of patient safety. It is why patients continue to die unnecessarily at an alarming rate in medicine without anyone in medicine being particularly concerned about it. Or even aware of it.

We need to stop expecting that caregivers will find the answers. They don't even see the problems. The people of good will at the top who are supposed to fix all this cannot. Not ever. The people between them and the patients will never produce good enough information for them to work with. Only self-serving information will be produced - same as always. The solutions will have to come from patients. They are the only ones with accurate information and an interest in the survival of patients that is not overwhelmed by other concerns.