Why ALLHAT is a Turkey

Andrew Pollack tells the story of ALLHAT the supposed gold standard of comparative effectiveness trials in today's NYT.

CMPI's chairman Michael Weber is quoted:

“There was a feeling there was a political and economic agenda as much as a scientific agenda,” said Dr. Michael Weber, a professor of medicine at the Health Science Center at Brooklyn, part of the State University of New York, who had been an investigator in the study but afterward became one of its leading critics. “They pushed beyond what the data allowed them to say.”

Critics said the rules of the trial had favored the diuretics. If the first drug did not adequately lower blood pressure — as happened in more than 60 percent of cases — a second drug could be added. But that second drug was usually a type that worked better with diuretics than with ACE inhibitors.

FDA's Bob Temple says: “This is the largest and best attempt to compare outcomes we are ever going to see,” he said. “And people are extremely doubtful about whether it has shown anything at all.”

So who is in favor of this big trials?

Those who want the government to dictate to doctors what to prescribe based on cost-driven clinical trial designs or think they will spit out precise answers that health plans can use to save money. But in fact such trials themselves have a political edge and often lead by people who themselves have a bias: Which is why Curt Furberg, the man who played fast and loose with the data to claim calcium channel blockers cause cancer, was forced to resign. Actually not the only reason. The other reason: the design of ALLHAT exposed African Americans to an excess risk of stroke and stroke related death. President-Elect Obama and his health advisers should bear that in mind in considering Furberg for any position.

So what's the verdict on comparative effectiveness research? Clinical trials of the size, scope and design of ALLHAT are inconclusive and often outdated, if not politically motivated. So what's the alternative that everyone is seeking to spend billionns on?

"Dr. Clancy (Carolyn Clancy director of the federal Agency for Healthcare Research and Quality) said that her agency was now mainly using insurance records to judge how treatments perform. While clinical trials are the gold standard, she said, they are costly and time-consuming.

And, she added, “You might be answering a question that by the time you are done, no longer feels quite as relevant.”

And that's going to save the US health system billions?

Research on how to achieve the best outcomes for patients is possible. But neither the ALLHAT approach or the review of insurance records is the way to do it.