Surviving the recession: medical research considered Lure In

 

Saturday, Mar 14,2009, 3:31:18 PM   Click:

Copyright: The Sacramento Bee, Calif.
Source: Sacramento Bee, The (CA)
Wordcount: 1183


March 13 - One in an occasional series to help you through difficult economic times.

Retirement slammed Carole Jacko. Raising two grandchildren, she is too young for Medicare and too committed to pay $ 600 per month for health insurance.

Thus, when a return to the emergency room ended with a diagnosis of diabetes, Jacko found a creative solution.

She became a medical guinea pig, offering science itself in exchange for free drugs, free doctor visits and even a modest payment.

"It really covers the costs," said Jacko. And the employees of the clinic are very good and professional. Â ... They keep an eye on you. "

With the economy fairing and millions of uninsured, some doctors and researchers believe the lure of volunteering for medical research is increasingly - and thus the potential ethical pitfalls.

"Sometimes, desperation drives people to be poor buyers" to conceal the risks or to gain the benefits imagined, "said Kevin Weinfurt, a professor at Duke University, which focuses on decision-making and the ethics.

No regulations limit the amount a person can be paid to take part in medical research.

The payments are often modest, however, usually intended to cover fuel, time or inconvenience. But the odd $ 25 here or $ 50, it may be overshadowed by the value of free medical care that would otherwise cost hundreds or thousands of dollars.

S. Elena MacLachlan, a nurse at the Oakland study for his doctorate, is ready to undergo what could be a sham surgery is lucky to get a new type of weight loss for the free functioning.

"I'm not in poverty. I have a good career. But my insurance does not cover, "she said, estimating the same transaction cost tens of thousands of dollars otherwise." I thank God for that. "


Researchers disagree about how much money it takes to cross the line and exert "undue influence" or coercion to get someone to enroll in a study. It's something to prohibit federal regulations.

"This is the most complicated in research ethics, and it remains an unresolved issue," said Weinfurt.

It has persisted for over 100 years since a surgeon at the Walter Reed Army appointed a voluntary position of $ 100 in Cuba or at risk of being infected with yellow fever. Men have another $ 100 if they have contracted the disease, to pay themselves - or any designated survivor.

The dangers Carole Jacko tracks are much less dramatic.

She participates in a study to assess how the three hypertension drugs work together. The combination of the study is approved in Europe, but not by the U.S. Food and Drug Administration. Even so, the United States and doctors can sometimes prescribe a combination already - but pharmaceutical companies are not allowed to promote such "off label" uses.

Jacko has signed a thick package of detailed disclosure known side effects of each drug, including nausea, headaches and kidney problems. More ominously, she warned, she should stop taking any medications during a "wash-out" before the start of the study, leaving her temporarily uncontrolled hypertension.

That, he said, a rare opportunity for a stroke or fatal or disabling of a heart attack.

"He does not really scare me," she says, because she knew that the trust and medical assistants, who saw her regularly.

With arthritis, diabetes and hypertension, Jacko, 60, can offer itself again and again for a variety of research.

In one study, blood pressure rose during the period of wash-out. Clinical monitoring of its staff closely, she says, and finally gave him the opportunity to switch to another research project.

Now she is back for more.

Every few weeks, it led to the Citrus Heights home, she left with her son and family at the offices of Dr. John Champlin in Carmichael. It rolls up its sleeve for a blood pressure, receives its blood, and leaves with a new range of drugs and $ 45 check - the payment of his days for the office visit.

"I have no medical insurance," said Jacko. "It'sa way for me to have blood tests and not have to pay the high cost of laboratory. ... This  prepared very well for me."

Champlin did not add the numbers, but he thinks he's more like Jacko patients as people lose their jobs and can not afford insurance.

As a physician specializing in primary care for patients who pay cash, Champlin has seen people who have to choose between medical care and groceries, which have to borrow from relatives to scrape the money test for a potentially lifesaving information.

Then he tries to advise patients about which tests they can safely postpone for a while. It allows you to negotiate for discounts on testing needed immediately. And it leads some patients to medical studies, which represent about 15 percent of his practice.

"There is a drawback to this," said Champlin. Some people who hoped to receive medication until the end obtain a tablet of sugar or other placebo that does them no good.

Others, however, benefit greatly. Sometimes the routine tests of the research up the underlying problems, from diabetes to cancer. Sometimes the studies do not use placebos, because they compare the standard with new drugs.

With Jacko, study participants in the practice of Champlin Don Munoz from Sacramento, who turns to medical research for palliative care because it is not insured, and Cheryl Cass Carmichael whose insurance has a strong franchise.


Then there's Mary McAmis of Fair Oaks, which has insurance and is part of studies in part to gain access to cutting edge treatments - and save money on co - payments.

Once, she was informed that a study, she was interrupted because of a drug has caused tumors in mice.

"I have not worried or anything," McAmis said, because, unlike the mouse, it is being studied for a relatively short time and perhaps received a placebo.

Until now, nobody is monitoring that people are more and more of research to save money on health care, but would be "a result quite possible our economic situation," said Christine Grady, deputy chief of bioethics at the National Institute of Health.

Grady considered compensation for the years of research, and think that paying research subjects for the time and the difficulty is simply to respect - as long as they know what they are getting into.

"What people worry if you're too short, some people ignore the risks or to be blinded kind of risk," said Grady.

The solution to this, she thinks, is to make information clear and detailed that people can the size of their own situation and make the best choices for themselves.

It is also important to remember that these choices are not held in a vacuum, "said bioethicist Weinfurt.

"The broader ethical challenge for society is that many people have no insurance for basic health care of those needs," he said. "Given that this is the situation I can imagine many cases where people understand the nature of the research ... and they are quite rational to join the study, to get what they want. "

Call The Bee's Carrie Peyton Dahlberg, (916) 321-1086.



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