Dr. Rath Research Institute

Thursday, 12 February 2009

Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.

The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors — even when they involve uses that have not been federally approved.

The FDA document, posted online Monday, comes just days before the Bush administration turns over power to President-elect Barack Obama's government.

"In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, D-Calif. "This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective."

For their part, companies like Pfizer Inc. and Eli Lilly said the guidelines merely reauthorize a long-standing policy that benefits doctors and patients.

"Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care," said Alan Bennett, an attorney representing the pharmaceutical industry.

Companies are not allowed to advertise products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, the FDA has allowed company salespeople to distribute articles about such uses if they are published in a peer-reviewed medical journal.

The law permitting that practice expired in September 2006, and drugmakers have been lobbying the agency to renew it ever since.

The reliability of medical journal articles came into question earlier this year when drugmaker Merck & Co. Inc. was accused of ghostwriting several articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons.

Reports published in the Journal of the American Medical Association alleged that Merck paid academics to take credit for articles which were actually written by the company. Merck denied the allegations, calling them false and misleading.

The FDA said the new guidelines are designed to discourage ghostwriting. Specifically, they recommend companies disclose any financial relationships with article authors and specify authors' affiliations.

Overall, though, the FDA remains supportive of distributing articles about experimental uses of drugs and medical devices.

"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency.

Democratic lawmakers including Waxman, the incoming chairman of the House Energy and Commerce Committee, have criticized the FDA's guidance, saying it represents a step backward in enforcement standards for the pharmaceutical industry.

Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the article's accuracy could be verified. Under the new proposal, drug companies don't have to submit articles to the FDA.

Waxman and other Democrats have said the change makes it easier for drugmakers to promote potentially risky medical practices.

Source

Google News / Associated Press
Author: Matthew Perrone
Source: http://www.google.com/

Comments

Pharmaceutical companies have already been doing such off label promotion of drugs for unapproved indications, however with this step such promotion is once again legal. Merck & Co. came into the spotlight for such unethical promotional practices of Vioxx, which was later recalled in 2004. According to these guidelines, companies can present journal articles to physicians and suggest extended applications of drugs that are not clinically tested for safety or efficacy. All they need is some data from peer-reviewed journal articles. It is a very common practice that such articles are written by ghost writers in the industry who are experts in presenting the data to appear positive. Also most of the journals depend on advertising revenues from the pharmaceutical companies. Although the FDA said these guidelines are designed to discourage ghostwriting and recommended that companies disclose any financial relationships with article authors, it is highly unlikely as there is no way for the FDA to monitor their actions.

Indeed, the FDA has detailed many conditions under which such article distribution would be "allowed." For example, reprints must "not be marked, highlighted, summarized, or characterized by the manufacturer in any way," "be accompanied by the approved labeling for the drug," "be distributed separately from information that is promotional in nature," among many others. However it is well known that the interaction between a physician and the pharmaceutical sales representative is far less transparent and it is impossible to keep an eye on such interactions occurring in physicians' offices. The FDA will have to depend solely upon the integrity and ethical guidelines of each company. With millions of dollars of profit at stake pharmaceutical companies get to monitor themselves! According to the key findings of a 2001 study researchers studied 722 million total drug promotions and found that 150 million drug promotions were off label. Of this group though only 28% had strong scientific support while the remaining 72% (which constituted 108 million incidents), were with little or no scientific support, and anticonvulsants, cardiac drugs, anti-histaminic and psychotropic drugs were at the top of the list.

While safe and effective nutritional supplements come under repeated scrutiny and a lot of negative publicity, the FDA has given a free hand to pharmaceutical companies to use their drugs and devices to as they please without any concern for the health of the public. For over a decade, Dr. Rath has been unveiling such practices and educating people about the same. Please read more about his work at: http://www4.dr-rath-foundation.org as well as in the book "Road Map to Health".