понедельник, 23 августа 2010 г.

What to Tell Alzheimer’s Patients After a Trial Goes Awry

So when Eli Lillyannounced last weekthat its promising Alzheimer’s drug was making patients worse and that it was halting two large clinical trials, it seemed likely that Dr. Ross would hear from family members of his patients. Are other experimental Alzheimer’s drugs safe? they might ask. Should they get their family members out of those Alzheimer’s studies?

Not a single family member called. And Dr. Ross is not sure why.

If a study of an experimentalbreast cancerdrug was ended because it made thecancergrow and spread, women in other breast cancer studies of similar drugs would be calling their doctors and asking what to do.

But Alzheimer’s is different.“It may reflect the incredible desperation surrounding Alzheimer’s disease,” said Baruch Brody, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

There is no treatment and no way to prevent Alzheimer’s. It is a leading cause of death, ravaging patients and their families.“Possibly, the overworked caregiver has precious little time to listen to news or read a paper,” Dr. Ross said.

Whatever the reason, the silence of Alzheimer’s family members gives rise to an ethical question. Do families now need extra protection or warnings about the Lilly experience when they sign up Alzheimer’s patients for studies?

There are no easy answers, ethicists and drug companies say, in part because it is not known what went wrong with the Lilly drug.

When patients enter studies or, in the case of patients with Alzheimer’s, when caregivers sign them up for studies, they or their caregivers sign an informed consent document. The forms are reviewed by ethics panels known as institutional review boards.

When the federal government conducts studies, it makes the consent forms public. Drug companies, though, generally insist that their forms be confidential. Investigators conducting studies for companies and institutional review boards must agree not to distribute the forms.

But every form contains a statement that warns patients that a drug might not help, said Angela Bowen of the Western Institutional Review Board, a private group which does ethical reviews of research on human subjects, including studies of Alzheimer drugs. The forms say a clinical trial is aimed at helping future patients. It is not a treatment for a disease.

The forms also say“there may be side effects that are not known at this time” and“your condition may not get better or may get worse during this study.”

It is often difficult to convey those ideas, said Dr. John Ennever, Western’s vice president for medical affairs.“We realize drugs can cause side effects and that sometimes they don’t work but we don’t think they can make conditions worse,” he said.

“We are dealing with humans who have hopes and aspirations,” he added.“The whole idea of research is a difficult concept. We all forget that if we knew the answer we wouldn’t be doing the research.”

The Lilly drug disabled an enzyme needed to make a protein, beta amyloid, that accumulates in plaques in the brains of people with Alzheimer’s disease. Other companies are testing different drugs that disable that enzyme, gamma secretase.

Researchers at other companies like Elan and Bristol-Myers Squibb said the Lilly drug, among the first of the gamma secretase inhibitors, took a sledgehammer to the enzyme. As a result, it probably affected levels of many other proteins besides beta amyloid. They say gamma secretase inhibitors now under development are much more selective and may be much safer.

Elan is one of those companies with a newer-generation gamma secretase inhibitor, and its chief scientific officer, Dr. Dale Schenk, said he did not think it necessary to emphasize the Lilly drug result to people taking his company’s drug.

“To be fair, this is the first anti-amyloid drug that has demonstrated a negative effect,” Dr. Schenk said.“I’m not worried about the class.”

Ted Yanock, Elan’s head of global research, agreed. Telling people taking the Elan drug about the Lilly results“would almost be misleading,” he said.


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