Here’s an article from Drug Industry Daily that examines the often fine line between off-label promotion and the free and open dissemination of scientific information.
There are a number of interesting issues at play here — not the least of which is how immediately defensive and uncomfortable pharma industry antagonists become when they are asked to be as open and transparent as the industry they so brutally attack.
Here’s an inconvenient truth — When the anti-pharma gang have their feet held to the fire they get hot under the collar.
Regulatory Changes to Drug Marketing Necessary, Journal Article Says
The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an Aug. 15 article in the Annals of Internal Medicine says. But former agency officials challenge the constitutionality of the recommendations and whether the government is in the best position to police the system.
Pfizer subsidiary Parke-Davis instituted a wide-ranging strategy to promote off-label drug use in the 1990s, which is indicative of fundamental ethical problems with industry marketing, the authors wrote. The study also illustrates the failings of physicians, professional organizations and the pharmaceutical industry to police such practices, they said.
However, three of the authors of the article, Michael Steinman, Mary-Margaret Chren and C. Seth Landefeld, worked as expert witnesses in a lawsuit against Parke-Davis concerning that off-label use. Also, the data used in the article was obtained by a database set up by the attorney representing the whistleblower plaintiff in that case, the report’s disclosures show.
According to the study, “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,’ the company used advisory boards, consultants’ meetings and accredited medical education events to get doctors to prescribe its drug Neurontin (gabapentin), an anti-seizure medication, for off-label use.
These efforts, along with recruiting doctors to influence other physicians and developing research solely to boost market share of the drug, were done without proper disclosure, they said. For example, the company’s involvement with clinical trials, medical journal research and reviews, educational grants and continuing medical education was not provided, they allege.
These findings signal a need for change, the authors said. “There is widespread agreement that commercial interests should not influence the clinical decisions that physicians make on behalf of their patients.” To address this, a complex system has developed using disclosure and self-regulation by doctors, professional organizations and industry. However, these efforts have been “largely ineffective,” as illustrated by Parke-Davis’ promotion of Gabapentin, the study said.
Incremental changes will fail because “marketing is so deeply embedded” and “the borders between research, education and promotion are more porous than is commonly recognized,” the study added.
Instead, new approaches are needed, including “rigorous regulatory oversight, strict sequestration of commercial and scientific activities and a fundamental internal reevaluation of the interactions between individual physicians, professional organizations and industry.”
Consumer advocates agree that changes are necessary. There is a growth in off-label use, many times based on little or no scientific support according to William Vaughan, senior policy analyst for Consumers Union. “Fixing this problem has to be a major priority,” he told DID. In particular, the FDA must take a stronger oversight role of off-label use.
But Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, disagreed. The FDA does not have the legal authority to restrict the dissemination of scientific information because doing so would be an unconstitutional restriction on First Amendment free speech protections, he said. In 1998, the Washington Legal Foundation successfully challenged the constitutionality of FDA restrictions on speech regarding off-label uses of FDA-approved products. This is a “closed issue,” he said.
Information also should not be discounted based on the motivations of an industry sponsor. “The public health can often coincide with private gain,” Pitts added. “Pure research is often done for a number of reasons.”
Another former FDA official, David Adams, chair of the law firm Venable’s FDA Practice Group and former director of the policy staff in the Office of the Commissioner at the agency, says that doctors should play a central role in preventing improper marketing, not the agency. “The government’s ability to regulate these interests is constrained by finite resources and constitutional protections,” he said.
“The most potent player in this arena is the physician. They have control over where they get their information on medical products, where and why they speak about medical products, who pays for their [continuing education] and what they call on regulators to do,” Adams said. “The signals are sometimes mixed.”
Pitts noted that the connection between the authors and plaintiffs in the lawsuit against Parke-Davis undermines their credibility, calling the link “extremely suspicious.” He also noted that as industry members on advisory boards have their industry connections scrutinized, industry critics should also face the same standards.
A Pfizer spokesman responded in similar fashion. “I think the financial and other connections between two of the authors of the study and a plaintiffs’ lawyer who has brought a lawsuit relating the marketing of Neurontin speaks
for itself,” said Bryant Haskins, director of corporate medial relations for Pfizer.
But Vaughan rejected this view, arguing that the facts themselves, not the background of the researchers are the issue. “It is a distraction to argue who or where the people writing the report came from,” Vaughan said.* “The proof is crystal clear: They got caught red-handed and are now using red herrings to divert people from the obvious documentation. It is an extraordinary treasure trove of documents that shows what lengths marketers will go.”
Pfizer agreed in 2004 to plead guilty to federal criminal charges, enter into a corporate integrity agreement (CIA) with the HHS Office of Inspector General and pay $430 million to settle allegations that one of its units caused doctors to submit Medicaid claims for unapproved uses of Neurontin. In 2003, sale of the drug accounted for almost $2.7 billion in profits.
Here is a link to the article: http://www.fdanews.com/did/5_161/
* The technical term for this is “pot calling kettle black.” (Note: This is my comment and does not appear in the article.)