This week the drug company AstraZeneca paid out £125m to settle a class action. More than 17,500 patients claim the company withheld information showing that schizophrenia drug quetiapine (tradename Seroquel) can cause diabetes. So why do companies pay out money before cases get to court?
An interesting feature of litigation is that various documents enter the public domain. This is how we know about the tobacco industry's evil plans to target children, the fake academic journal that Elsevier created for Merck's marketing department, and so on.
One of the most revealing documents ever to come out of a drug company emerged from an earlier quetiapine case: an email from John Tumas, publications manager at AstraZeneca. In it, he helpfully admits that they do everything I say drug companies do.
"Please allow me to join the fray," Tumas begins, in response to a colleague. "There has been a precedent set regarding 'cherry picking' of data." Cherry picking is where you report only flattering data, and ignore or bury data you don't like. The ears of lawyers prick up at any use of the word "bury" in relation to drug company data, as it implies something deliberate, and luckily John uses this word himself. The precedent, he explains, is "the recent … presentations of cognitive function data from trial 15 (one of the buried trials)"...more
In the United States, pharmaceutical corporations are allowed to conduct clinical trials on foster children because all studies, paid for through Medicaid, are protected from public disclosure under privacy laws of child welfare and FOIA exemptions and exclusions.
One cannot mislead the public if the public never knows...
A new study from researchers at Children's Hospital Boston suggests that clinical trials that are funded through sources within the pharmaceutical industry are more likely to give positive results than those funded through other means...more
Ghostwriting is a typical practice in the academic world and is not limited to the medical profession.
You have a broad range of special interest groups that can influence social policy from outside the elected officials office from a more indirect manner, and that is through benefactor activities.
You will find this in scholarships, fellowships, and most other funding initiatives. Take foster care for example. You have universities who set up their own child welfare institute who will only publish research that is beneficial to its federally funded revenue-maximization scheme due to the fact that most social work training in child welfare is funded through Title IV-B and E initiatives.
Should more light be shed on the relationships between drug makers and certain prominent doctors who publish scientific articles about their medicines?
A new Congressional report calls on medical journals, medical schools and even the National Institutes of Health to take additional measures to ensure the integrity of the scientific articles many doctors rely on to make treatment decisions for their patients.
The report, issued Thursday by Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, focuses on medical ghostwriting.
Ghostwriting is the practice in which prominent researchers sign on as authors to articles for scientific journals that have been developed by third-party medical education companies at the behest of drug or medical device makers. Influential doctors listed as authors, the report said, have had varied input on articles drafted by industry-financed writers that have been published in medical journals.
“Manipulation of medical literature could lead physicians to prescribe drugs that are more costly or may even harm patients,” the report said.
Over the last few years, industry documents made public in government investigations and product liability lawsuits against drug makers have shown medical ghostwriting to be widespread.
In response, many medical journals have tightened their policies requiring authors to disclose industry funding and editorial assistance. Last year, the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, revised its clinical research principles, adopting standards that ask authors to disclose industry contributions to research publications.
A number of drug makers have also changed their publication policies to acknowledge their supporting roles. Some leading medical schools, meanwhile, have added policies explicitly prohibiting faculty from signing on to ghostwritten articles.
But the senator’s report said a variety of scientific institutions, including the National Institutes of Health, should be more vigilant to ensure the integrity of the medical literature.
Even when articles in medical journals acknowledge industry-sponsored medical writers for “editorial assistance,” for example, the role of drug makers in such publications may remain unclear to readers, the report said. A drug maker may have initiated an article, chosen the medical writer, influenced the outline or draft before it is sent to an academic author for review, or vetted the final manuscript, before it is submitted to a medical journal, according to the report.
Senator Grassley recommended in a separate letter to Dr. Francis S. Collins, the director of the N.I.H., that applicants who apply for agency research grants should be required to disclose any industry support, whether financial or editorial, that they have received for articles.
A spokesman for the N.I.H. said the agency had received Mr. Grassley’s letter and would respond at a later date. It already is considering a new rule to increase disclosure of the financial sponsorship of researchers seeking grants.
