Researcher rejects study results

A Sun Health scientist Wednesday ripped the findings of a large government study, which concluded that two common painkillers cannot prevent Alzheimer's disease or slow mental decline in older people.

The arthritis drug Celebrex and the over-the-counter painkiller Aleve showed no benefit on thinking skills, the new findings show. Earlier results from the same research showed the two drugs didn't prevent Alzheimer's, at least in the short term.

But Sun Health Research President Dr. Joseph Rogers, who was directly involved in the recruitment for the study, said any conclusions drawn from the incomplete study are unjustified.

"It's a failed study. It's all that could have been said or should have been said. I don't think drawing any conclusions from this study was justified," he said.

Rogers said neither he nor colleagues at Sun Health Research Institute, one of the leading Alzheimer's research centers in the world and the leading recruitment center for the study, knew anything about the findings of the study until they were published. He said because the study ended early, a conclusion should not be surmised from any data collected.

"I think a study that was never completed is somewhat suspect," he said. "When you don't finish an experiment and you begin to tout the results ... when you publish a paper on incomplete data, that's a bit alarming."

The study was designed to last five years but was ended early in 2004 when heart risks turned up in a separate study on Celebrex, Rogers said. Researchers also had noticed more heart attacks and strokes in the people taking Aleve in the Alzheimer's prevention study.

"The majority of patients didn't even get a year in the study because adverse reactions to Celebrex," he said. "The trial was halted and disbanded. It is very much an incomplete, misguided attempt."

In addition to his disagreement with the conclusion, Rogers said neither he nor his investigators were given the chance to review or comment on data from the study.

"It's a paper that our investigators should have been consulted about," he said.

Despite the study's early end, researchers felt there was still enough data to hint at how the drugs act on thinking and memory. The findings were posted online Monday and will appear in July's Archives of Neurology.

"These were not the results we were hoping for," said co-author Barbara Martin of the Johns Hopkins Bloomberg School of Public Health. "We designed this study hoping we would see a protective effect of these drugs."

Researchers hope to continue monitoring the participants to see if they find any delayed benefit.

Scientists have speculated that nonsteroidal anti-inflammatories, such as Aleve and Celebrex, might prevent Alzheimer's by reducing inflammation in the brain or by other means.

"The drugs have several effects in the brain and the different effects could be important at different stages in the illness," said study co-author Dr. John Breitner of the University of Washington in Seattle.

Previous studies had found that people who took the drugs ran a lower risk of developing Alzheimer's. But those were observational studies, meaning they observed people's behavior and health. The people who took the pills may have had other healthy habits that lowered their risk.

The halted study included more than 2,000 people ages 70 and older with a family history of Alzheimer's but no thinking problems themselves. People were randomly assigned to take standard daily doses of either Celebrex, Aleve, also known as naproxen, or a dummy pill.

At the start and annually for up to three years, they took a battery of tests. In one, they named as many grocery items as they could in one minute.

All three groups scored about the same at the start. But over time, the Aleve takers scored on average slightly lower than the people who took placebos. The Celebrex takers scored slightly lower than the placebo takers on most, but not all, of the tests.

"There's no evidence that people should be on these drugs to prevent Alzheimer's disease," said Dr. David Bennett of Chicago's Rush University Medical Center, who was not involved in the study but does similar research. "With the side effects of these drugs, people shouldn't be taking them for this reason."

Both products now carry warnings about heart risks. Anti-inflammatory drugs also can cause serious gastrointestinal bleeding. Experts advise patients to ask their doctors about how long to take the drugs for pain.

The study was funded by the National Institute on Aging.