If David could speak from his grave: Regulations on drug companies' gifts to doctors

David Olson's story appeared here more than a year ago.

Officials in the Massachusetts Department of Public Health are now writing regulations about the disclosure of gifts that doctors get, e.g., from drug companies, according to an article by Liz Kowalczyk in the Boston Globe of Dec. 6.

If David could speak from his grave, he might want his voice heard loud and clear on this. A drug company was paying David's psychiatrist thousands of dollars for participating in a drug study. After David's death, the state medical board criticized the doctor, concluding that he had "failed to appreciate the risks of taking Patient 46 off Clozaril, failed to respond appropriately to the patient's rapid deterioration and virtually ignored the patient's suicidality." It's hard to avoid concluding that the payment of thousands of dollars for recruiting each of a number of patients into the drug trial had affected the doctor's judgment.

Worse, this was no "bad apple." The doctor was the president of the Minnesota's psychiatric society.

Officials in Massachusetts are now considering whether doctors must disclose payments for research and research-related activities. Note that, whatever they decide, doctors will be free to receive these payments. The issue at stake is only whether patients will be able to find out about it.

Advice: Work to ensure that doctors disclose the sources of their money.

Read a story about a different conflict of interest by a doctor.

The journey started from a phone call in the back of a taxi: Learning of clinical trials of new drugs.

Courtney Hudson's story
Late one Sunday evening In January 1999, my husband called me on his cell phone from a taxi. He was seriously ill and on his way to the hospital. The doctors were able to stabilize him temporarily, but they recommended additional surgery. My husband refused to undergo what would be a long, difficult operation that would require months of recovery. I was obviously upset - not only about my husband's condition, but also about his apparent unwillingness to accept treatment.

I was torn between the competing desires to respect his choices and for him to get treatment immediately. I began to search for treatment options, mainly through the Internet, but found the information presented too simplistic, too scientific, or too voluminous. By chance, a friend in California sent my husband an article about an alternative surgery that had only recently been developed. This surgery was being performed only a mile from our home in New York, yet we had never heard about it. My husband underwent the surgery, and today is doing fine.

We were lucky, but access to new treatment options, including clinical trials, should not be serendipitous. This is a time when pharmaceutical companies, biotech companies and the government have enlisted the support of nearly 50,000 doctors to conduct more than 10,000 clinical trials each year -- almost one-third are designed to test new drugs and therapies for cancer patients. Patients and families should have a way to find these new drugs and therapies without having to depend on luck.

After months of interviews with patients, advocates, caregivers, and researchers, Sarah Hutter, Glenn Rice and I founded EmergingMed.com in January 2000 to offer patients and their families a fast and easy way to find and understand available treatment options.

We have created the EmergingMed online matching and referral system to reliably connect patients directly to the doctors conducting clinical trials in a matter of minutes.

This personal journey, which started with a phone call from the back of a taxi, will hopefully benefit many others by providing more options for their own treatment and by accelerating the clinical research process that develops new drugs and therapies for all of us.

Advice to patients thinking of surgery: Figure out all your options first.

Read another clinical trial story.

Thanks to Courtney Hudson for the source at the EmergingMed.com website.

Together with his oncologist: Matchmakers for new drug trials for multiple myeloma

Diagnosed last fall with smoldering multiple myeloma, 45-year-old Glenn Codderre relies on his oncologist for the standard drug regimen now used to treat the disease. Glenn, a Boston-area consulting manager for Hewlett-Packard, began his search for trials through the nonprofit Multiple Myeloma Research Foundation, which contracts with EmergingMed.

Together with his oncologist, he decided not to participate in one trial EmergingMed found because of concern about side effects and the trial drug's interaction with his current medications. He says the consultant he works with at EmergingMed "helps me save time and stay informed on clinical trial options while I continue to balance family and professional responsibilities." He hopes they will find a drug trial and that the drug being tested will slow the progression of his disease to cancer.

For-profit matchmaker firms like EmergingMed help patients identify experimental drugs that might help them and connect patients with the appropriate clinical trials. In Glenn's case, an effective drug might slow the progression of his disease to cancer. EmergingMed narrows its searches by taking into account the stage of the disease and the patient's prior treatments.

EmergingMed gets paid through fees that it charges medical centers, advocacy groups and research sponsors. The company's web tool is free to patients. The company doesn't disclose personal information gathered on its web site.

Advice to the families of cancer patients: Consider using a matchmaking service to find a clinical trial of a drug that could help your loved one.

Read another clinical trial story.

Thanks to Laura Landro for the source article in the Wall Street Journal of May 14.

Rats and mice get better protection: FDA and informed consent for human subjects

The case of Audine Graybill demonstrates the flaws in the system. According to the U.S. Food and Drug Administration, in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 said she could change her mind at any point in the study.

She checked into High Pointe healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, she changed her mind and asked to leave.

Dr. Linden refused to let her go.

On June 6, she was given the experimental medicine. Her lawyer, Anthony Sykes, presented a writ of habeas corpus to High Pointe to obtain her release. But the hospital staff neither obeyed it nor gave it as requested to Dr. Linden.

More than nine months later the FDA discovered many other problems there, but only this summer finally wrote a warning letter. Meanwhile, the Oklahoma Board of Medical Licensure and Supervision suspended the doctor's license.

Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his website.

According to today's front-pagestory in the New York Times, Audine's experience is quite common because of lax management by the FDA.

"Rats and mice get greater protection as research subjects in the United States than do humans," said Dr. Arthur Caplan, Chairman of the Department of Medical Ethics at the University of Pennsylvania.


Advice to human subjects in clinical trials: Talk through your rights with a patient advocate or lawyer.

Read another of our informed consent stories, or read Gardiner Harris’ source story in today’s New York Times.