Drug companies have paid Utah doctors $25.8 million since 2009 for research, consulting, travel and entertainment — a common practice, the scope of which is only now becoming clear and causing uneasiness in medicine.
That’s the state’s share of over $2 billion in payments nationally, according to the latest update to ProPublica’s "Docs for Dollars" database, the largest repository of these payments.
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Read more about Dollars for Docs
Pro Publica, an independent, non-profit newsroom, compiled two million records totaling $2 billion in payments from 15 pharmaceutical companies to health professionals nationwide. Read an explanation of how it assembled the database and its national overview story.
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What is a clinical trial?
Trials test new drugs and medical devices on humans after they’ve been government approved as safe and effective in lab and animal tests.
Phase I studies focus on safety. These tests can last several months and usually involve a small number of healthy volunteers, 20 to 100, who are generally paid to participate. The studies investigate side effects at different dosage levels. About 70 percent of experimental drugs pass this phase.
Phase II studies test the effectiveness of a drug or device and can last several months to two years. They tend to involve hundreds of patients are generally randomized, which means some patients will receive the experimental drug while another “control” group receives a standard treatment or placebo (no treatment). Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. About one-third of drugs make it past this phase.
Phase III studies are large-scale tests involving hundreds to thousands of patients and lasting several years. These are meant to provide a deeper understanding of a drug’s risks, benefits and range of side effects. Most drugs that make it this far, 70 to 90 percent, pass this phase and are approved for marketing.
Phase IV studies are done with drugs already on the market to compare the drug to others, monitor it’s long-term benefits and gauge their cost-effectiveness. These studies can result in a drug being taken off the market or having restrictions placed on its use.
Learn what questions patients should ask before entering a drug trial at: http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143531.htm
http://www.nih.gov/health/clinicaltrials/basics.htm
Sources: The U.S. Food and Drug Administration (FDA) and CenterWatch, a company in Boston that produces drug-industry publications and operates a clearinghouse to connect patients with clinical trials.
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Payments to Utah have grown six times in four years, and that only spans 15 manufacturers that account for 47 percent of the U.S. drug market.
Such payments have been secret for decades. But in recent years drug makers started disclosing them, some as a result of legal settlements.
Federal law requires all manufacturers to publicly report such data starting in 2013, an effort by the Obama administration to expose potential conflicts of interest. Research has shown such payments can influence doctors’ treatment and contribute to higher medical costs as patients are steered to pricey, brand-name therapies.
"Industry ties don’t necessarily mean that a physician is practicing bad medicine or making biased decisions," said Aaron Kesselheim, a doctor and assistant professor of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School.
"But if a physician is recommending a certain procedure, say, or a certain expensive brand-name drug, then knowing a physician has a lucrative connection to the manufacturer of the device or drug may weigh into a patient’s decision to accept the physician’s recommendation or perhaps seek a second opinion," he said. "Making this information available and user-friendly is extremely important."
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Industry funding research. » In Utah, ProPublica’s data also spotlight a multimillion dollar industry of contract research organizations, or CROs, private companies that drug makers pay to test their drugs.
Among them is CRI LifeTree Research, which has received at least $3.4 million in drug company payments since 2009, according to ProPublica.
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Co-founder Lynn Webster, an anesthesiologist, is listed as having received the single largest payment in the state: $1,687,771 from Cephalon, a big maker of pain medications. Only three other doctors in the country received more from Cephalon.
Nationally, Webster is among the top 50 for single largest payments received, behind marquee hospitals, such as the Mayo Clinic, Cleveland Clinic and Duke and Harvard Universities.
A nationally recognized expert in pain management, Webster is under investigation by the U.S. Drug Enforcement Administration, which is looking into opioid overdose deaths of patients of his former pain clinic. A Senate Committee is probing his financial ties to Big Pharma.
Webster no longer sees patients, but serves as a medical director at LifeTree’s South Salt Lake location. Research payments to him cover overhead and other costs, including his salary as a lead researcher, he said.
"Research inevitably leads to better education, better systems and better therapies — things that are indispensable for medical advancement and quality care," he said.
At Salt Lake City-based Foothill Family Clinic, primary care physician and obstetrician Shane Christensen conducts industry trials on contract through the CRO J. Lewis Research. He was paid just over $756,000 by two drug companies between 2010 and 2012.
The payments cover overhead, seven full-time research coordinators, 13 sub-investigators and stipends for participants, he said. He said he understands the large payments may leave some with a negative view of the drug industry, but adds the costs of conducting trials that meet federal regulatory standards add up fast.
"But we have the safest drugs," he said. "Everybody wants the advancements of medicine. The dichotomy is, that if you don’t do research, (the drugs) might harm you."
Christensen said he likes that the work puts him on the front end of medical advancements that may help his patients. But participation in any study is "a personal choice," he stressed.
"We spell it all out. There’s informed consent," he said. "Some people are totally interested and glad to get on a study. Other people would never, ever do a study and use the ‘guinea pig’ reference.
Rules on payments are stricter today than the days when drug companies wined and dined doctors, said Derek David Muse, a family doctor and part-time researcher for Jean Brown Associates, a CRO in Millcreek with 17 open trials, most of them for vaccines and pain medications.
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