Federal health study says consent forms for early-stage cancer research don't mislead

<br>While cancer patients participating in studies of experimental drugs may mistakenly expect benefits without risks, it's probably not because of the consent forms, federal researchers say. <br><br>Their

Thursday, December 26th 2002, 12:00 am

By: News On 6

While cancer patients participating in studies of experimental drugs may mistakenly expect benefits without risks, it's probably not because of the consent forms, federal researchers say.

Their study found that the forms nearly always say the goal is to test the medicine's safety, not to help patients.

``If there is a misunderstanding ... there's probably another reason,'' such as patients' desperate hopes, said lead researcher Christine Grady of the clinical bioethics department at the National Institutes of Health's Warren G. Magnuson Clinical Center.

Her review of 272 consent forms was reported in Thursday's New England Journal of Medicine.

It showed that less than 5 percent of forms said a cure was possible, while about 80 percent stated that severe or permanent harm was possible; about two-thirds mentioned death as a risk.

Grady said the main problem is that forms repeatedly used the word ``treatment'' without saying it is ``experimental.'' ``It's possible that people reading the documents with the term ``treat,'' ``treat,'' ``treat'' over and over get the idea this is a more established treatment,'' she said.

Ethicists and government officials have been concerned whether potential risks have been played down or benefits overstated to get patients with advanced cancer to participate in the first human tests of new cancer drugs.

The so-called Phase 1 trials mainly determine a safe dose for a new compound or drug combination. The patients recruited generally have advanced cancer and little hope, and few benefit from the brief treatment.

Researchers at the Magnuson center reviewed consent forms for Phase 1 cancer experiments conducted in 1999. Most came from top cancer research centers supported by the National Cancer Institute; 10 percent were from six pharmaceutical companies.

Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania, said the unexpected deaths of several patients in cancer and gene therapy experiments over the past decade have led to better consent forms.

But he said the terms ``therapy'' and ``treatment'' should ``just be off limits'' in consent forms, as well as news releases and media reports about such experiments.

Caplan thinks patients don't always read the forms carefully, and some don't understand them because of language or cultural barriers, undiagnosed mental problems or fear of their disease.

``Studies show people are much more influenced by what the doctor says,'' he added.

Penn's Center for Bioethics, which Caplan directs, is trying to design a study to observe that doctor-patient conversation _ without influencing what's said.