Clinical trial  guidelines from PhRMA, the drug industry trade group, go into effect on October 1, 2009. The big news is that there is now a more restrictive definition of who exactly can contribute and be credited in the authoring of scientific papers. From the Wall Street Journal Health Blog: New Pharma Guidelines: No Ghostwriting, More Public Info:

Anyone who makes “substantial contributions” to a study, writes or revises intellectually important parts of a manuscript and has final approval over what is published should be listed as an author, the guidelines say. People who contribute but don’t qualify as authors should be listed in the acknowledgments. If authors get help, they “should disclose the identity of the people that provided the assistance and any entity that supported it.”

Companies should post “summary results” of all clinical trials of drugs that have been approved for sale, and of drugs that have been dropped from the pipeline, the guidelines say. This is relevant because companies have been criticized for publicizing results that reflect well on their drugs, and burying results that make their drugs look bad.

Trials of experimental drugs that are still in development are exempted because posting trial results could “jeopardize important intellectual property,” the guidelines say. Also worth noting: The guidelines aren’t retroactive, so they’ll apply only to new findings.

A doctor who has an ownership stake in a drug can’t be a clinical investigator in a trial of that drug. So if a doc discovers a drug, then licenses it to a pharma company, the doc can’t be one of the researchers who treats patients in a study of the drug. That would “present an inherent conflict of interest,” the guidelines say. Why is this worth flagging? Ask Chuck Grassley.

Read it all.

In a rare excursion into the facial plastic surgery arena, US News & World Report this week published a pretty darn good story on recent research by Michael P. Ondik, MD, and colleagues at Penn State Hershey Medical Center. Best Option for Fractured Nose Varies by Patient (hat tip to Luxie):

The treatment of nasal fractures is a controversial topic. Some surgeons recommend no intervention, some prefer closed reduction (minimally invasive repair), and others favor extensive open surgery, according to background information in a news release about the study.

"Closed reduction is a relatively simple procedure, at times producing acceptable outcomes. However, advocates of open reduction purport better cosmetic results and a high likelihood that closed reductions will eventually need a second operation sing an open reduction technique," the researchers wrote.

"Deciding which technique to use for a given nasal fracture can be challenging. Not all fractures can be treated using closed techniques and, conversely, not all fractures require the time and expense of an open reduction," the study authors noted.

In this study, Ondik and his team looked at data from 86 patients treated for nasal fractures between 1997 and 2007. Of those, 41 had closed reduction and 45 had open surgery.

"There was no statistical difference in revision rate, patient satisfaction or surgeon photographic evaluation scores between the closed and open treatment groups when fractures were treated in the recommended fashion," the researchers found.

The rest of the news story is here. The Ondik et al study appears in the September/October issue of the journal Archives of Facial Plastic Surgery.

In hammering out health care reforms, US Senators on the Finance Committee are now considering proposals to change how medical malpractice lawsuits are handled.

The first possibility is to establish a special courts in which a judge with medical expertise would hear malpractice case, according to Sen. Kent Conrad (D-ND). Under this scenario, it is assumed that a medical judge would not be as easily swayed by emotion as lay juries. Another possibility includes the option of arbitration and some liability protection for doctors following “best practice” clinical standards in treatment of patients. From the Associated Press via Google:

Many economists are skeptical that malpractice insurance premiums paid by doctors — or even the practice of defensive medicine to avoid litigation — are major reasons for soaring health care costs. But the issue looms large politically because many conservatives in both parties are convinced that doctors routinely order up tests their patients don't need because they're afraid of getting sued.

Obama's overture in his Wednesday night speech could give him a way to peel off some Republican votes, as well as shore up support from moderates in his own party. The president said that while he doesn't see malpractice changes as a "silver bullet," he's talked to enough doctors to suspect that fear of litigation contributes to unnecessary costs. He's directing the Health and Human Services Department to provide funding for pilot programs to test some alternatives to litigation.

"I hope this signals a commitment to meaningful malpractice reform," said Sen. Mike Enzi, R-Wyo., one of only three Republicans in the Senate still negotiating with Democratic counterparts seeking an elusive bipartisan compromise.

Doctors' groups, which lost the battle for national limits on jury awards for pain and suffering, now see a possibility for other ways to reduce malpractice lawsuits.

Read about it here and here -- including responses from AMA spokespersons and a poor soul representing trial lawyers (who see the possible changes will be ruinous for them).