Ferreting out safety problems with prescription drugs sooner--such as those that plagued the popular pain medication Vioxx--could be possible if the government adopted a new system that would pool data from clinical trials for widely prescribed drugs, according to a group of researchers publishing in Archives of Internal Medicine.

Reports the New York Times: "Such a database could be continually updated and aggregated with new information, as the results of new studies were published, to calculate a near real-time balance sheet of a drug’s risks and benefits." While drug makers and researchers already conduct meta-analyses on aggregated clinical trial results, the new system proposes that the pool of information be continuously updated.

But such a new system would require an act of Congress, which would need to grant new powers to the U.S. Federal Drug Administration (FDA) to implement it. As we reported in our multi-media investigation on clinical trials, Heart of the Matter, the pharmaceutical industry is a powerhouse on Capitol Hill, employing hundreds of lobbyists with close ties to key lawmakers and spending millions in campaign contributions. It's not known at this point how the drug industry would respond to such a proposal.

[crossposted from Real Time Investigations.]

Following up on President Obama's January 21 memo requiring agencies to promote transparency and openness, the Food and Drug Administration (FDA) has created a Transparency Task Force to create recommendations to make the FDA more open and transparent. The largely secretive process of review and approval for drugs and medical devices is garnering the most attention as any attempt to open up this process would greatly affect thousands of corporations and the entire American public.

The FDA has had serious problems in disclosing problems with medications, over-the-counter drugs, and devices to the public with troublesome results. The New York Times writes, "the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers."

This transparency effort may be one of the more important ones for the administration, as most Americans rely on the FDA to provide accurate information as to whether a drug or device is not to be used, or what dangers may exist. An FDA that does not have the trust of consumers would assuredly cause increased risks in health decisions and lead to profit loses for companies manufacturing drugs and devices. Transparency is essential to instill trust in this area.

If the recommendations do include more transparency for drug and device reviews Congress would likely have to change laws that govern confidentiality at the agency. As the Times notes, passing a bill through Congress that the pharmaceutical industry has a great interest in derailing would be a difficult task.

The pharmeceutical industry spent a little more than $29 million on campaign contributions during the 2008 election cycle. The industry only spent more on campaign contributions in the 2002 cycle when Congress debated a bill to provide prescription drug coverage through Medicare. The industry spent a combined $234 million on lobbying in 2008 and has already spent $66 million this year. Any effort that is opposed by the pharmaceutical companies would have to overcome this juggernaut of political influence.

Transparency at the FDA is instrumental to a healthy and consumer confident country. The task force should ensure that the American consumer is readily and well information about the products they use.

Next in our series on why it's so important that Congress #ReadtheBill, and provide access to legislation to the public as well, is a little noticed law regulating drug and medical device approval approved in 2007. The final version of 422-page Best Pharmaceuticals for Children Act was available for only one hour to the public before the House and Senate voted to approve it. (Make sure to sign our Read The Bill petition here.)

In September 2007, the House and Senate hurried through consideration of the bill, meant in part to respond to widespread concerns about unsafe drugs and medical devices making their way into the marketplace. The rush had more than a little to do with the fact that the user fee programs that fund safety reviews at the Food and Drug Administration (FDA) were about to expire at the end of the month. Without that funding, the agency would be hamstrung.

On the House floor, Rep. Frank Pallone of New Jersey described the quick action as a rescue mission. An earlier version of the legislation, he said, had been languishing because of a breakdown in negotiations between the House and Senate. Now, however, he said everybody was behind the new version, H.R. 3580, introduced that very day, and the Senate had agreed to approve it by unanimous consent.

“Mr. Speaker, most of us are too young to remember, but in the early days of the movies there was a series of movies based on the “Perils of Pauline,” he said on the House floor. “Pauline was a heroine who always got tied to the railroad track, and just as the train was bearing down on her the hero would come out and rescue her for another adventure in the next movie reel…. [W]e’re going to rescue Pauline and pass the [law]…and lots of good things are going to happen.”

While the new law made some changes to strengthen the drug and medical device safety system, it lacked many of the provisions for which safety advocates had argued. For example, a coalition of groups, including Center for Science in the Public Interest, Consumers Union, National Research Center for Women & Families and the National Women’s Health Network, had called for a two-year moratorium on direct-to-consumer ads for new drugs—those ubiquitous magazine advertisements for the latest drug to cure depression, reflux and other common ailments. In 2004, Merck recalled Vioxx, an arthritis drug made popular by aggressive ad campaigns, because of concerns about increased risk of heart attack and stroke by long-term users. In addition, the law’s new provisions on medical devices had not been publicly reviewed or debated in a Senate hearing.

On September 19, the same day it was introduced, the House voted 405 to 7 to pass the bill. The Senate approved it the following day by unanimous consent, and the president signed it a week later.

Since the passage of the law, news reports show new concerns about the FDA’s safety record. A new report from the U.S. General Accounting Office (GAO) criticizes the agency [pdf] for letting medical devices on to the market without adequately reviewing their safety. And a group of nine agency scientists has come forward and blown the whistle on lax agency practices in reviewing devices. For example, they charged that agency higher ups overruled scientist to improve the sale of an imaging device for breast cancer after receiving a phone call from a then-Connecticut congressman, Rep. Christopher Shays.