The first clinical trial in the United States using stem cells to treat congenital heart disease in newborns will soon be under way at the Mayo Clinic in Rochester. Darcie Radel a technologist at the Human Cell Therapy Laboratory at the Mayo Clinic removed a tray of cryovials of umbilical cord blood mononuclear cells which are being used in a heart study.
Richard Sennott, DML - Star Tribune
New report shows impact of clinical trials in Minnesota
- Article by: James Walsh
- Star Tribune
- December 13, 2013 - 9:16 PM
To Dr. Gary Berman, an allergist and immunologist with the Clinical Research Institute and with Allergy and Asthma Specialists in the Twin Cities, the fact that thousands of Minnesotans participate in hundreds of pharmaceutical clinical trials every year is a great thing for patients with chronic illness.
One advantage, he said, is that it gives those patients access to new and novel therapy. Another is that they get medications, and health care included in the trial, for free.
“It’s good for patients,” he said. “From what I have seen and what we do in our clinic, it’s a win-win.”
Since 1999, nearly 3,000 clinical trials have been conducted by pharmaceutical companies in Minnesota, according to a report released Friday by the Minnesota Clinical Research Alliance, which has partnered with the Pharmaceutical Research and Manufacturers of America. More than 400 of those trials — which are testing drugs that treat everything from asthma to cancer to cardiac disease — are currently enrolling participants. The alliance released the report to draw attention to an industry they say benefits Minnesota to the tune of 31,000 jobs and $23 million in state and local taxes.
But at a time when the industry is under fire for what critics say is a lack of transparency and accountability in clinical trials — funded and conducted mainly by the industry itself — some question the motives behind reports such as “Research in Your Backyard.”
“It’s pure PR for the contract research industry. As far as I can tell, they’ve rolled out ‘news events’ like this all over the country for the past two years. But I can’t see any news value to these reports at all,” said Dr. Carl Elliott, a University of Minnesota professor, bioethicist and author.
The pharmaceutical industry, and how it uses data from clinical trials, is under even more scrutiny after this year’s publication of “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients.” The book, by Dr. Ben Goldacre, highlights what the author calls a flawed system that results in the findings of many clinical trials being hidden from doctors and patients, and government regulators not providing tough enough scrutiny.
Elliott was asked what people who are thinking of enrolling in a clinical trial should do to protect themselves.
“It’s a mistake to think that patients can protect themselves,” he wrote. “The problem is that these [oversight] bodies are so incredibly weak and ineffective.”
Jeff Trewhitt, author of “Research in Your Backyard,” disagreed.
In an interview, he said that new drugs take 10 to 15 years to get to market — including about seven years in clinical trials — because of the demands of regulators. The U.S. Food and Drug Administration “is a tough taskmaster,” he said.
Trewhitt said the development and testing of new drugs often involves tens of thousands of pages of data, data that show the benefits and the risks involved. Patients who participate in clinical trials, he said, are warned about those risks when they enroll. And, he said, transparency in clinical trials is improving, including the National Institutes of Health putting information on the Web at www.clinicaltrials.gov.
Asked what patients who are considering enrolling in a clinical trial should do, Trewhitt encouraged them to first meet with their own physician and “put down all questions and concerns you have. Clinics are obligated to answer every question you have.
Berman said his organization, Clinical Research Institute, with locations in Minneapolis and Plymouth, has run clinical trials for more than 20 years. Much of its work tests prospective new drugs for asthma, allergies, COPD and migraines, he said. They are currently enrolling patients in about two dozen clinical trials.
While it is often difficult to get enough people enrolled, he said, recent questions about clinical trials have not depressed business. In fact, his institute gets a lot of repeat volunteers — people who like getting free medications, who like getting free lab tests. They like getting access to new treatments that could potentially be better than what they have used, he said.
“Our goal is to make life better for our patients,” he said. “The treatments that have come out the last 20 years have remarkably changed their lives. And that can’t be done without the research being conducted.”
Berman said that when he started practicing medicine, he saw asthma patients in the hospital every week. Now, thanks to new drugs, “I can’t tell you the last time I was in the hospital to see someone because of asthma.” Clinical trials are a big reason for that success, he said.
James Walsh • 612-673-7428
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