By John Goodman
While the nation is mourning one tragedy in Arizona, you may also be aware of another. The state has decided to deny organ transplants to some Medicaid enrollees. I will use this as a segue to focus on three issues I want to revisit anyway:
- Selective Outrage. On the part of the president, the Congress and almost the entire health policy community: If a private insurer does it, it’s immoral; if a public insurer does it, it’s an unfortunate budget issue.
- Comparative Effectiveness Research. You didn’t know? That was the excuse Arizona used.
- Death Panels. Okay, maybe Sarah Palin didn’t know what she was talking about. But what else would you call it when lawmakers effectively deny several dozen people extra months and years of life in order to save some taxpayer dollars?
I’ll zero in on the second one, because that, my friends, is what is very much in your future. Since there has been a lot of intellectual dishonesty on both sides of this issue, let me give you a brief overview.
Comparative effectiveness research (CER) first came to the attention of ordinary Americans through Tom Daschle’s book, Critical: What We Can Do About the Health Care Crisis. Daschle had nothing but praise for the British National Institute for Cost Effectiveness (NICE) and recommended that we do something similar in America. Doctors often use procedures that research shows are ineffective, wrote Daschle, and even when they work there are often equally effective procedures that are much less expensive. The answer: a commission to survey the research and the evidence, and publish the results for all doctors, health authorities and even patients to see.
So far so good. Who can be against research to determine whether we are wasting money? Also, although Daschle was somewhat imprecise about how all this worked, in truth NICE has no power to deny patients anything. Similarly, the CER bureaucracy called for in the new health reform bill would also have no power to deny any patient any therapy.
So is CER harmless? Far from it. What few people want to clearly say is that CER from beginning to end is designed to give cover to public and private insurers who want to reduce spending on medical care.
In Britain, for example, 25,000 cancer patients die prematurely each year, according to the World Health Organization (WHO), because they do not get drugs that are routinely available in the United States and continental Europe. Roughly, NICE considers a drug not cost-effective if it involves spending more than about $30,000 to save a year of life.
Also, what is never clearly said is that the burden of proof is being shifted to anyone who wants to use an expensive procedure and in meeting the burden of proof, the bar is going to be quite high because (a) clinical trials are expensive, (b) they are time consuming, (c) if they do not have a lot of patients, procedures that are actually effective will still show up as “statistically insignificant,” and (d) they almost by design ignore the fact that different patients can have different responses to the same procedure.
Consider what Arizona has done:
- In denying liver transplants for hepatitis C patients, the state argued that the disease recurs 100% of the time. Granted, but the patients still gain extra years of life — 80% are still alive after one year and 60% after five years. According to one study, the cost per quality adjusted life year (QALY) ranges from $17,000 to $200,000.
- In denying lung transplants, the state argued that the procedure was “palliative, rather than curative,” that patients can only expect to live a half-year longer and even that result is statistically insignificant. Critics respond that the study the state relied on was 15 years old and involved only 49 patients — too few to really show statistically significant results.
- In denying bone marrow transplants to leukemia patients, the state argued that 13 of 14 transplant patients were dead within 6 months. But national statistics show the survival rate is more than 40%.
- In denying heart transplants for patients with non-ischemic cardiomythopathy the state argued that medication and less radical surgeries were just as effective. Again the critics disagree.
Overall, the American Society of Transplantation, the American Society of Transplant Surgeons and the United Network for Organ Sharing sent a letter to Arizona Governor Jan Brewer criticizing the cuts. Arizona “used data that were outdated or data that made no sense, or they misinterpreted or misrepresented what experts said,” says Michael Abecassis, director of Northeastern University’s comprehensive transplant center and president of the surgeons group.
As an addendum to all of this, let me repeat that a therapy may work for some patients even if it doesn’t pass a clinical trial for a random sample of patients. Witness the FDA decision to recommend that the drug Avastin no longer be used to treat breast cancer. More than 9,500 cancer patients and friends and family have signed a petition urging the FDA to keep Avastin approved.
As Aaron Carroll has pointed out (and other, less careful writers have not), the FDA cannot tell doctors what to do. Since Avastin has been approved for other purposes, any doctor can prescribe Avastin “off-label” for breast cancer patients. The problem is that Medicare and private insurance now have a good excuse not to pay for the treatment.
Finally, in my comments on “selective outrage” I must exempt Aaron Carroll who has been almost alone among health policy wonks in condemning the Arizona decisions. Even so, Aaron is a supporter of the new health reform bill.
Let us have your thoughts in the comment section. Do you agree that as Arizona goes, so goes the nation?