Are Clinical Trial Results Compromised By Money?

[Pharma Newshound]

Source: TheDenverChannel.com

Research Looks Into Medical Misconduct, Disclosure

DENVER -- More than $84 billion is spent to develop drugs each year. But the rush to create better pills could be costing you more than their money. It could cost you your health.

Are clinical trial rigged? The results skewed? That's the question asked by Public Citizen in Washington, D.C.

"Many medical journals are becoming marketing instruments for the drug companies," said Dr. Sidney Wolfe, director of the Health Research Group of Public Citizen.

A new study finds two 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 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," said Dr. Peter Laurie.

After astronaut and flight surgeon Duane Graveline's cholesterol went up from 230 to 270, NASA doctors put him on Lipitor. But an under-reported side effect changed his life.

"I didn't know my wife and I didn't know my home," Graveline said.

Graveline was suffering from transient global amnesia. Graveline found studies not widely reported that show statins impact cholesterol in your brain that affects memory.

"Not one of these has been reported back to the medical community," Graveline 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," Turner said.

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.

"No study is perfect. The large majority come to conclusions that can be questioned," said Dr. Jerome Hoffman, professor of medicine at UCLA.

So how do you fix the problem? Some experts say take private funds out of research. The downside 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.

Additional Information

It's a crucial question that remains unanswered: How common is scientific misconduct? The actual numbers are a matter of great controversy.

In a study conducted by Dr. Daniele Fanelli of the University of Edinburgh, he focused on behaviors that actually distort scientific knowledge (excluding data on plagiarism and other kinds of malpractice) and looked at how often scientists who recalled having a lapse in ethical behavior when it came to reporting results.

On average, about 2 percent of scientists admitted they had made up, falsified or altered data to "improve the outcome" at least once. Up to 34 percent admitted to other questionable practices including "failing to present data that contradict one's own previous research" and "dropping observations or data points from analyses based on a gut feeling that they were inaccurate."

In surveys that asked about the behavior of colleagues, 14 percent of scientists knew someone who had made up or changed data and up to 72 percent knew someone who had committed other questionable research practices.

In both surveys, medical and pharmacological researchers reported misconduct most frequently. Fanelli makes sure to add that in all surveys asking sensitive questions, it is likely that some people did not respond honestly, especially when talking about their own misconduct.

A dispute over misconduct and disclosure prompted one of the country's most prestigious medical journals to change its procedures. The controversy revolved around a 2006 study in the New England Journal of Medicine that said the widespread use of CT scans could prevent 80 percent of lung cancer deaths.

However, critics said the journal and its publisher, the Massachusetts Medical Society, didn't disclose "relevant financial conflicts of interests of the authors."

The study failed to report that the doctor's works had been underwritten in part by a $3.6 million grant from the parent company of a cigarette maker. The journal now asks authors to disclose all patents or royalties related to their research and it publishes the information with the studies.

One of the difficulties to address the issue of scientific misconduct at the international level stems from the wide diversity of definitions and procedures. For example, the US Office of research integrity has adopted "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results," as a definition.

The Committee on Publication Ethics preferred a broader definition: "Behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards."