PharmAware Blog

http://www.bbc.co.uk/iplayer/episode/b00jcjc5/The_Medicalisation_of_Normality/

As part of its drive to cut health-care costs, the Obama administration wants to stop the payments pharmaceutical companies make to generic-drug makers to delay the launch of cheap copies.

Wall Street Journal, 31/3/9

http://online.wsj.com/article/SB123843757514670479.html

PharmedOut (www.pharmedout.org) has released The Pharmalyzer: Are you prescribing under the influence?, an interactive continuing education module, at www.pharmedout.org/pharmafree.htm or www.fsmb.org/re/open/modules2.html. This unique module helps prescribers assess their susceptibility to pharma influence. U.S. physicians can receive 3 free continuing medical education credits. Anyone may view it, but you have to answer the questions to proceed through it.

A few years ago, The Journal of the American Medical Association started publicly admonishing some authors who failed to disclose potential conflicts of interest with drug companies and other medical industries. That was a warning shot to those who ignored JAMA’s demands that such conflicts be voluntarily disclosed lest they taint the published research.

You would think, given this hyper-aware atmosphere, that the editors of JAMA or any other major medical journal would welcome any help they could get in patrolling its authors’ conflicts.

You would think that until you heard about Jonathan Leo, a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn.

Leo recently posted a letter on the Web site of the British Medical Journal that criticized a study about the anti-depressant drug Lexapro that had appeared in JAMA. Leo identified an important omission in the study—and pointed out that the lead author had a financial relationship with the maker of the drug that wasn’t disclosed.

Did Leo get a grateful call from JAMA, thanking him for his sleuthing? Not quite. According to The Wall Street Journal, Leo said he fielded an angry and threatening call from JAMA executive deputy editor Phil Fontanarosa shortly after Leo’s letter was published.

When a Journal reporter called JAMA editor-in-chief Catherine DeAngelis about Leo, she reportedly said: “This guy is a nobody and a nothing. He is trying to make a name for himself. Please call me about something important.”

In an online editorial published last week, JAMA editors disputed Leo’s version of his conversation with Fontanarosa. They said that the Journal had “erroneously reported” DeAngelis’ comments about Leo.

“As a faculty member [assistant dean of students] of a school preparing physicians who will care for patients, Leo certainly is ’somebody doing something’ very important,” the editorial said. You could almost feel the solicitous pat on the head.

Leo had first notified JAMA of problems with the study, but had heard nothing from the editors for several months. So he decided to go public. The editors said that on the day Leo posted on the Web site, JAMA was six days away from publishing a letter and detailed correction about the study. In other words, they say Leo was right, but he should have been more patient.

JAMA, you’re not looking good here.

Leo says he uncovered the conflict in a simple Google search, the kind that anyone, say, at JAMA could do in a few minutes. He wonders why JAMA took so long to confirm the information.

Good question.

JAMA now says it is clarifying its policy for how it handles allegations of unreported conflicts of interest. The tipster will be told not to reveal information to “third parties” or the media while the investigation is under way. But that alone won’t get to the heart of the problem. JAMA took much too long to investigate the allegations, creating the impression that it didn’t take them seriously. And if editors did direct their anger at the whistle-blower, JAMA has another serious problem.

JAMA, your credibility is at stake.

ChicagoTribune, 28/3/9.

A nonprofit group that monitors industry links to medical research called for the suspension of the top two editors of the Journal of the American Medical Association, and an investigation into allegations that they threatened a researcher who criticized a study published in the journal.

The Alliance for Human Research Protection, which is often critical of industry-academic ties, made the requests in a letter it sent Wednesday to the American Medical Association.

The Wall Street Journal, 27/3/9.

The American Medical Association is seeking an investigation of claims that editors of its leading medical journal threatened a whistleblower who pointed out a researcher’s conflict of interest.
Editors of the Journal of the American Medical Association deny threatening a professor who raised concerns about a study author’s undisclosed financial link to a drug company when JAMA published the study last year. JAMA, like most leading medical journals, has a policy of noting scientists’ industry connections.

According to the Wall Street Journal, JAMA editors threatened to ban the professor from their journal and ruin his medical school’s reputation if he didn’t stop talking to reporters.

The editors deny that. But the flap prompted them to spell out what amounts to a gag order on anyone who alerts the medical journal about suspicions that a researcher has undisclosed industry ties. The journal editors argue that any suspicions should be kept secret until JAMA can complete its own probe. That is an existing policy, JAMA’s editor-in-chief, Dr. Catherine DeAngelis, told The Associated Press on Monday.

AP Medical Writer, 30/3/9

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

The American Psychiatric Association said on Wednesday it will end medical education seminars and meals sponsored by drug companies at its annual meetings to reduce chances for financial conflicts of interest.

The group, which represents 38,000 doctors, is among the first to say no to the drug-company sponsored seminars at its meetings, which many critics say blur the line between education and advertising.

Reuters 25/3/9
http://www.reuters.com/article/domesticNews/idUSTRE52O5YA20090325