Let’s not pop the champagne corks just yet to celebrate the recent announcement of new guidelines for Big Pharma from the trade group Pharmaceutical Research & Manufacturers of America (PhRMA). The wordy guidelines are called Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. They went into effect last week, and are a response to mounting scandals and scrutiny about how clinical research trials are conducted and reported. These new principles also cover issues like authorship contributions and medical ghostwriting; disclosure of financial conflicts of interest; public registration of clinical trials; and publicly accessible summaries of all clinical trial results.
These last two are apparently a stab at addressing the current reality that negative clinical trial results either never see the light of day or are only selectively reported to favour the drugs being tested. The principles have been hailed by some as a step in the right direction, although many point out that they may have more bark than bite in addressing, for example, the chronic problem of medical ghostwriting.
Commenting on these relatively toothless new principles in a Heartwire interview, cardiologist Dr. Steven Nissen of Cleveland Clinic highlighted the niggling issue of compliance and enforcement.
“The new PhRMA guidelines are useful, but will have little impact in solving this chronic problem. The guidelines are voluntary, and history has taught us that such efforts rarely succeed. There is no penalty for violation of these recommendations.”
As previously reported by the news service Heartwire, advocacy groups likePhRMA have been stepping up efforts to distance themselves and the companies they represent from real or apparent conflicts of interest linking researchers, products, and industry sponsorship.
To combat the fraudulent practice of Big Pharma ghostwriting, Dr. Nissen claims that a bigger impact would be gained with strict enforcement by medical journals of their ghostwriting rules, “including severe penalties for violation.”
And perhaps more important, physicians and researchers themselves must refuse to accept authorship offers when they haven’t been intimately involved in the studies. Dr. Nissen also points out that the new principles focus on disclosure – they don’t even explicitly prohibit third-party preparation of a manuscript.
“Accordingly, a drug company could still develop a manuscript through a medical education and communication company” (like DesignWrite of New Jersey, who wrote and successfully submitted 26 medical journal articles in praise of Wyeth Pharmaceutical’s hormone replacement therapy drugs Premarin and Prempro – conveniently leaving out the nasty bits like increased deadly risks of heart disease, breast cancer and dementia for the women who took the Wyeth drugs).
“These industry-funded articles could then still be given to a physician to submit to a medical journal as the actual author. Even if the participation of ghostwriting companies like DesignWrite is revealed, such activity would not violate the PhRMA guidelines; however, it would still be unethical.”
Find out more about the PhRMA document, or about medical ghostwriting.
You are right! THese guidelines sound pitifully inadequate.
Let’s put some muscle into this issue for a change and quit pandering to the powerful Big Pharma lobby machine.
What is the purpose of having guidelines, any guidelines, that are so useless?
I think the translation of these industry guidelines here might be “blah blah blah”, the usual reaction to protocol guidelines that are meaningless and have no consequences if you violate them.