An article that has today appeared in the Plos Medicine Journal has called for medical ghostwriters to be held legally liable for infringing academic standards and contributing to fraud.
The co-authored article, written by, Xavier Bosch, Bijan Esfandiari and Leemon McHenry, cites possible avenues where legal action could be taken against those who lend their names to published studies written by pharmaceutical company spin doctors.
The Plos article rightly clams:
"Guest authors lending their names to ghostwritten articles touting the safety and efficacy of a drug have an independent duty to exercise ordinary care and prevent injury to others as a result of their conduct."
Because of this, the authors write, that guest authors may be legally liable and argue that the only way to halt this is through litigation.
Personal Injury Lawsuits"Sections 310 and 311 of the Restatement allow injured third parties to recover from a person who has made an intentional and negligent misrepresentation inducing action that involves a risk of physical harm."
Federal False Claims Act (FCA or Whistleblower Statute)"FCA inflicts civil liability against persons or entities presenting false payment claims or using false records or statements to get claims paid or approved or causing third parties to do so.
"The potential that participating in a ghost authored article can result in liability for conspiracy under the FCA may be another deterrent to the unethical practice of guest authorship."
Anti-Kickback Statute"Since paying physicians to become honorary or guest authors of a ghostwritten paper may influence their clinical judgment, subsequently increasing product sales (and government health care costs), and putting patients at risk by misrepresenting risk-benefit, both physicians and sponsor companies may be legally liable."
US attorney's Baum Hedlund have issued a press release regarding the Plos article where they write:
Numerous examples of medical ghostwriting have been uncovered in lawsuits involving drugs such as Neurontin, Paxil, Zoloft, fen-phen, Vioxx and Prempro where courts have unsealed formerly confidential internal company documents. In other cases, the extent of medical ghostwriting remains under court seal (e.g., Avandia, Zyprexa, Seroquel, Bextra and Celebrex).
I've always been astounded that pharmaceutical companies who settle with claimaints are allowed to seal documents that are of a massive public interest. On one hand they settle out of court with claimants, on the other they stop documents from reaching the public, in essence, this stops further suits being brought against them.
It's only through items of disclosure that we can get to the bottom of who actually writes what, a classic example would be the, now infamous, Paxil 329 studies that were, for many years, thought to be written by a whole host of key opinion leaders. In fact, the Paxil 329 study was written by GlaxoSmithKline hired ghostwriters who 'bigged up' the use of Paxil in adolescents and claimed, "Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."
Years later, after many millions of Paxil prescriptions were written for adolescents, it came to light that the Paxil 329 study was not authored by KOL's, they merely lended their names to it to add credibility and to persuade healthcare professionals that Paxil was indeed safe to use in kids. What the study failed to mention was the suicide link, a key safety issue they conveniently left out. Those who lent their names to the study should have asked questions, they should have requested the raw data. Instead they were each paid handsomely and endorsed a study that put children and adolescents in jeopardy. That's unforgivable and the authors will have to carry that around with them for the rest of their lives, as will the ghostwriting team hired by GlaxoSmithKline.
I echo the sentiments of the authors of the recent Plos article. A slap on the wrists should not be the punishment for allowing a drug on to the market that is basically a bullet. These co-conspirators are, like GlaxoSmithKline, guilty of wanton neglect on the most vulnerable in our society - Children.
That's a crime in anyone's book!
Fid
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