Medicine's Not-So-Silent Killer: Studies Under Scrutiny

PORTLAND, Ore. (Ivanhoe Newswire) -- Each year, $84 billion is spent on drug development. The rush to create better pills and more effective medicine could be costing the people who take them more than their money -- it could cost them their health. Is medicine losing out to the almighty dollar? Are clinical trials rigged? The results skewed?

There's a lot on the line. The prescription drug market is a $162 billion dollar a year business. But some say the studies done to get these drugs to market can -- and are -- being manipulated.

"Negative studies? We don’t hear about them," Peter Lurie, M.D., Deputy Director of Public Citizen's Health Research Group, told Ivanhoe.

“Many medical journals are becoming marketing instruments for the drug companies," Sidney Wolfe, M.D., Director of Public Citizen's Health Research Group, said.

A new study finds 2 percent of scientists admit they have fabricated, falsified or altered data to improve the outcome at least once. About 35 percent admit to questionable research practices. A JAMA study reveals that 30 percent of the original research studied was either false or exaggerated. Problems include small study size, design flaws, publication bias and failure to publish negative results.

"A smart drug company -- maybe not an ethical one, but a smart one -- might decide to publish only those studies that put its drug or device in the best light," Dr. Lurie said.

Case in point: $25 billion worth of statins are sold each year to help lower cholesterol. Pharmaceutical companies are racing to create a new improved product.

“Every statin company is trying to make people believe their statin is better than another one," Dr. Wolfe said.
 
After astronaut and flight surgeon Duane Graveline’s cholesterol went up from 230 to 270, NASA doctors put him on Lipitor. An under-reported side effect changed his life

“I didn’t know my wife, and I didn’t know my home," Graveline told Ivanhoe.

Graveline was suffering from transient global amnesia.

“The doctors said, no, no, no, statins don’t do that," Graveline said.

Graveline found studies -- not widely reported -- that show statins impact cholesterol in your brain that affects memory.

“In our attempt to control the blood cholesterol, the statin drugs were adversely affecting the brain," he added.

Graveline found about 1,000 cases of amnesia reported to the FDA.

“Not one of these has ever been reported back to the medical community," he said."

Erick Turner was a doctor who reviewed trials for the better part of his career. When he became a reviewer for the FDA, he got the surprise of his life.

“I, first of all, was shocked at the number of negative trials, because I had never seen a negative trial before," Dr. Turner, Senior Scholar at the Center for Ethics and Health Care at Oregon Health and Science University in Portland, told Ivanhoe. "I had been clueless … These were studies that simply weren’t getting published, or perhaps they were being presented in a way that made them look positive."

A JAMA study found industry-sponsored research was positive 87 percent of the time compared with 65 percent of non-industry-sponsored research. UCLA professor Jerome Hoffman says it’s not just the companies that profit from positive results.

"The financial success of medical journals, particularly the major journals, is intimately tied to meeting the needs of the companies that sponsor these big studies," Dr. Hoffman told Ivanhoe.

The push is on for more disclosure. This year the New England Journal of Medicine now requires authors to disclose any patents or royalties related to their research and it publishes the information with the studies. JAMA and other journals have followed suit. Many believe this is the first step to fixing the problem.

“No study is perfect," Dr. Hoffman said. "The large majority come to conclusions that can be questioned."

Those inaccuracies and misrepresentations can end up costing lives.

Some researchers believe the only way to completely fix the problem is to take private funds out of research. The down side to that? Private companies have more money to spend on research than the federal government. Others are pushing for a drug trial registry that would allow the public to see if any trials ended with negative results.

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