CER ethics controversy spills over to health debate
[Editor's note: Clinical trial sites and research institutions soon might benefit from an increase in funding for studies involving comparative effectiveness research (CER). President Barack Obama and the U.S. Congress have agreed to spend $1.1 billion on CER, which is expected to include some clinical trials, as well as observational studies, and synthesis research. Clinical Trials Administrator asked experts in CER to discuss how this new funding might change clinical trials research. In this issue, there are stories about CER controversies and CER overseas. In the September issue, there were articles about what CER is and how it might change the research enterprise, how to best use CER, and what types of research grants might be funded.]
CER ethics controversy spills over to health debate
Most extreme views aren't the norm
It was a foreshadowing of a health care reform debate that has one side arguing that living wills are suicide pacts between patients and clinicians.
One speaker at a listening session of the Federal Coordinating Council for Comparative Effectiveness on June 10, 2009, accused the council of using Nazi tactics to deny medical care to frail people through the promotion of comparative effectiveness research (CER), according to a transcript of the session.
"The apparatus here is to deny medical care to elderly, chronically ill, and poor people, and thus save, as the President says, $2 to $3 trillion by taking lives considered not worthy to be lived, as the Nazi doctors said," claimed Anton Chaitkin, a speaker at the council's listening session.
"Disband this council and reverse the whole course of this Nazi revival now," Chaitkin implored the council.
Council members moved on from Chaitkin's remarks, which according to some attendees seemed incredibly off the wall. But during Congress' summer break, these bizarre charges were often repeated and snowballed, and not just about CER.
"There is a lot of publicity that happened recently against comparative effectiveness research," notes Mark S. Roberts, MD, MPP, president of the Society for Medical Decision-Making and a professor of medicine, health policy, and management and industrial engineering at the University of Pittsburgh School of Medicine in Pittsburgh, PA. Roberts also is chief of the section of decision sciences and clinical systems modeling in the department of medicine at the University of Pittsburgh.
This especially is true among some of the more conservative aspects of American society, says Roberts, who spoke at the council's June 10 listening session.
"They feel it's just one more way of trying to ration care and do cost-containment, and I think that's just fear," Roberts says. "The goal of CER is not necessarily to save money, it's simply to understand what the best treatment is in a particular setting."
The fact that the government will expand its involvement in health care, including its funding of CER, raises ethical issues for some.
"We're trying to improve the system, but the question is, 'Will it be controlled by the government with decisions made by governmental officials, or will people make these decisions themselves?'" says Grace-Marie Turner, president and founder of the Galen Institute, a health policy research organization in Alexandria, VA. Turner also spoke at the council's June 10 listening session.
When the stimulus bill was written with funding for CER there was no public debate about whether this was something the federal government should be doing, Turner says.
"There's a lot of evidence from other countries that have implemented similar systems like in the UK, where we have a lot of information about the complexities of trying to do it," she adds.
The government's role
While comparing one treatment to another is a good idea, it shouldn't be the government's role to make that decision, Turner says.
"One of the things you hear all the time is how glad patients are that there are different medications available for the same conditions," she explains. "I'm afraid the federal government will say, 'This drug is better than that one, and this one will be paid for, and another is not.'"
Not all groups reporting to represent consumers agree, however.
"I know that several patient groups, including those that receive money from pharmaceutical companies, are being encouraged to worry about the government taking decision-making away from doctors," says Diane Zuckerman, PhD, president of the National Research Center for Women & Families in Washington, DC.
"Unfortunately, a lot of doctors need to have decision-making taken away," she says.
Zuckerman offers this example from her personal experience: "I needed an antibiotic, and the doctor was going to prescribe a very expensive antibiotic, and I said, 'Is there anything else I can get because I have no prescription coverage for drugs and this will cost me over $100?'" she recalls.
"His next idea was a different prescription that was much cheaper, but it made me so nauseous that I had to stop taking it after three days," she says. "So I finally said, 'Can't you just prescribe amoxicillin?'"
The physician didn't think it would be strong enough, but he prescribed the $10 prescription of amoxicillin; Zuckerman took it, and she recovered just fine.
"So why did the doctor start out with a $100 drug, and then lower it to a $35 drug, before finally prescribing a $10 drug?" she asks. "I almost never take antibiotics, so there was no exposure to antibiotic resistance."
This is what some physicians do, she adds.
"He likes this expensive drug, and so it's his first choice, and most patients just do what he says," Zuckerman says. "Amoxicillin is so cheap that nobody advertises it and promotes it, and fewer and fewer doctors are prescribing it."
A lot of what physicians do doesn't benefit patients as much as is possible, Roberts says.
"There are stakeholders who don't like the world to know that," he says.
CER could help improve patient care because it would give physicians additional and necessary information about the drugs they prescribe, he adds.
"With a new drug, if you really want to understand whether or not it works, it makes absolute sense to study it in a population where it's highly likely to show effectiveness," Roberts says. "But that doesn't mean that's the final say or the only important piece of information you can get out of [clinical trials on the drug]."
Clinicians also need information that compares one drug to another one or the same treatment because randomized, control data doesn't answer that specific question, he says.
"The whole idea is to answer questions clinicians face every day about treatments A, B, and C," Roberts adds.
Wrong drug, wrong reason
Another reason why CER is needed is because too many medications are being marketed to the wrong populations for the wrong reasons, some experts say.
For example, one of the most popular U.S. drugs is quetiapine fumarate (Seroquel©), which originally was approved for treating schizophrenia. However, it's been widely prescribed, far beyond schizophrenic patients, and now people are being given the drug to treat anxiety and depression, Zuckerman says.
"If you look at the data, Seroquel is not particularly effective at treating anxiety or depression," she adds. "It can lower scores on the depression scale, but probably because it is effective at treating insomnia, which is one of the many symptoms of depression."
The way it treats insomnia is by making people extremely sleeping and lethargic, she explains.
"They're yawning all day long and barely functioning, and so they sleep well," Zuckerman says. "But is that a proper treatment of depression?"
Plus, according to the medication's label, the drug has serious side effects, including the potential to cause sudden cardiac death. It also can cause diabetes and obesity.
"So here you have a 16-year-old, depressed girl, and let's give her a drug to make her fat — that's really helpful," Zuckerman says.
CER would provide data about how this drug compares with others used to treat anxiety and depression and give clinicians clear information about what works best and is safest for various populations.
"When the FDA approves a new drug, it's approved on the basis of it working better than a placebo, and almost never does it have to work better than any existing drug," Zuckerman notes.
"I mentioned to the FDA commissioner that it's really important that the FDA maximizes the information available to patients about drugs being approved," Zuckerman says.
"And also they should compare them because comparative effectiveness research is really important," she adds. "And the FDA should work with other agencies because it was contributing hugely to the cost of health care, and people were getting less effective drugs for five to 10 times the cost."It was a foreshadowing of a health care reform debate that has one side arguing that living wills are suicide pacts between patients and clinicians.
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