Review of Drug Truths: Dispelling the Myths about Pharma R&D by John L LaMattina
Drug Truths, written by a research chemist who spent his career with Pfizer, presents a view of the industry from inside these laboratories, far from the suit filled boardrooms where the business is conducted. Although he exchanged his white coat for a pinstripe suit as he moved during his career from the bench to become Pfizer’s president of global research and development, John LaMattina has not lost his awe and sense of wonder at the drug discovery business and breathlessly presents this side of the industry as he attempts to bust the so called myths that surround it.
BMJ 2009;338:b1138
The United States Department of Justice filed a civil complaint last month against Forest
Laboratories in a district court in Massachusetts, alleging that the company violated the federal False Claims Act. The department’s complaint says that the company marketed its antidepressants citalopram (marketed in the US as Celexa) and escitalopram oxalate (Lexapro) for use in children when the drugs were not approved for such use, that the company paid inducements to doctors to promote use of the drugs in children, that the company failed to disclose a study showing that Celexa was not effective in children, and that the government was defrauded of millions of dollars because federal health insurance programmes such as Medicaid paid for prescriptions for the drugs that were not covered by off-label paediatric use.
Under the statute, the justice department says, “the government can recover treble damages and $5500 [£3800; €4000] to $11 000 for each false or fraudulent claim filed.” Forest Laboratories issued a statement saying that it was currently reviewing the government’s complaint and would respond at the appropriate time. It also said it was continuing its discussions with the government about the investigation.
In a related issue, Forest was at the centre of a controversy last week when it emerged that the Journal of the American Medical Association had taken five months to act on criticism that the lead author of a paper published in the journal had not declared a conflict of interests.
A letter from the lead author, Robert Robinson, of the University of Iowa, admitting that he had not disclosed previous funding from Forest, was published in JAMA after Jonathan Leo, from Lincoln Memorial Hospital in Harrogate, Tennessee, publicised the details of the conflict of interest in an electronic letter to the BMJ (www.bmj.com/cgi/eletters/338/feb05_1/b463#208503).
BMJ 2009;338:b1222
The BMJ is now asking authors for data sharing statements at the end of each original research article. The statement will explain which additional data—if any—are available, to whom, and how. Those data could range from additional explanatory material to the complete dataset. People allowed access to the data might range from fellow researchers to everyone. And data might be available only on request, accessible online with a password, or openly accessible to all on the web with a link on bmj.com.
Data sharing means more than the open access publication of articles and the posting in online registries of study protocols and main results. Sharing allows other researchers—and perhaps scientists, clinicians, and patients—access to raw numbers, analyses, facts, ideas, and images that do not make it into published articles and registries. At its fullest extent, data sharing means free access for everyone. Many people would call this a moral obligation because most research is publicly funded and involves the public as participants. Other potential benefits include quicker scientific discovery and learning, better understanding of research methods and results, more transparency about the quality of research, and greater ability to confirm or refute research through replication.
For full article, go to BMJ 2009;338:b1252