Making Government Transparent and Accountable
The Sunlight Foundation uses cutting-edge technology and ideas to make government transparent and accountable. Underlying all of our efforts is a fundamental belief that increased transparency will improve the public's confidence in government
The Sunlight Foundation Blog
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White House Health Proposal May Blow Up PhRMA Deal
This morning the White House released a new health care proposal that may be used as a blueprint for a compromise between House and Senate versions of reform. This new proposal will likely not find a receptive audience at the Pharmaceutical Research and Manufacturers of America (PhRMA)–the chief lobbying arm of the pharmaceutical industry.Throughout 2009, PhRMA and major pharmaceutical companies crafted a deal with the White House to limit cost cutting by the industry in exchange for the industry’s support, through over $100 million in television advertising, for health care reform. (The entire story behind the crafting of the deal can be read here.) The White House’s new proposal contains deeper cost cuts than previously agreed to and contains regulations on the relationship between brand-name and generic drug companies that the industry opposes.
The deeper cost cuts come from an attempt to further close the “donut hole” in the Medicare Part D prescription drug program. The “donut hole” refers to the gap in coverage that occurs within Medicare Part D. For those purchasing prescription drugs through the program coverage cuts off at $2,700 spent and does not pick back up again until $6,154 is spent by the participant. The current language that was struck in the deal between the White House and the pharmaceutical industry maintains that drug companies would cover 50 percent of the cost for brand-name drugs for participants falling in the “donut hole.” This change would be implemented within the year. The White House’s new proposal would eliminate the “donut hole” by 2020 by making participants pay only 25 percent coinsurance with Medicare covering the other 75 percent. The White House also takes a page from the House health reform bill by providing a $250 rebate to Part D participants who fall into the “donut hole.” (The House bill provides for a $500 reduction in costs for participants who fall into the “donut hole.”) (Continue reading…)
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The Legacy of Billy Tauzin: The White House-PhRMA Deal
More than a million spectators gathered before the Capitol on a frosty January afternoon to witness the inauguration of Barack Obama, who promised in his campaign to change Washington’s mercenary culture of lobbyists, special interest influence and backroom deals. But within a few months of being sworn in, the President and his top aides were sitting down with leaders from the pharmaceutical industry to hash out a deal that they thought would make health care reform possible.
Over the following months, pharmaceutical industry lobbyists and executives met with top White House aides dozens of times to hammer out a deal that would secure industry support for the administration’s health care reform agenda in exchange for the White House abandoning key elements of the president’s promises to reform the pharmaceutical industry. They flooded Congress with campaign contributions, and hired dozens of former Capitol Hill insiders to push their case. How they did it—pieced together from news accounts, disclosure forms including lobbying reports and Federal Election Commission records, White House visitor logs and the schedule Sen. Max Baucus releases voluntarily—is a testament to how ingrained the grip of special interests remains in Washington.
In the 2008 campaign, Obama declared his intention to include all stakeholders as he sought to reform the nation’s health care system, but also supported key Democratic health reform policies. Among these were several that targeted the pharmaceutical industry: Allowing re-importation of drugs from first world countries with lower drug prices and providing Medicare with negotiating authority over prescription drug prices in the recently enacted Part D program. These weren’t just promises, Obama had already voted for both of them as a senator in 2007. (Roll Call Vote 132 and Roll Call Vote 150.)
Set to carry out this agenda were two Capitol Hill veterans, schooled in the monied Washington culture, chief of staff Rahm Emanuel and deputy chief of staff Jim Messina. Emanuel was a former fundraiser, Clinton administration official, investment banker and member of the Democratic leadership in Congress. Messina was the former campaign manager and chief of staff to the powerful Senate Finance Committee chairman Max Baucus. Both were known for their unparalleled legislative abilities.
Because of Obama’s decision to develop a plan operating through the legislative process, members of Congress also played key roles. Early on, the pharmaceutical companies were told to deal directly with Senate Finance Committee chairman Max Baucus. Baucus would be the vehicle for the deal worked out behind the scenes by the White House and PhRMA. (Continue reading…)
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Researchers propose real time analysis of drug safety data
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.]
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FDA Creates Transparency Task Force
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.
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Drug trial data at your fingertips
Unless you or a family member has suffered a serious illness, it’s unlikely that you’ve run across the site ClinicalTrials.gov, run by the U.S. National Institutes of Health. Available since 2000 and enhanced by a 2007 law which requires more extensive reporting, this site contains a database of nearly 71,000 drug trials conducted by privately and publicly funded researchers in 50 states and 164 countries. The website gets 40 million page views per month and 50,000 visitors a day.
Using ClinicalTrials.gov easy-to-use search interface, you can type in a search such as “breast cancer AND Denver,” or “asthma AND Pittsburgh” and get a list of relevant drug trials that are underway or have been completed. Thanks to the 2007 law, over a three-year period this information is being expanded to include information about actual results from these trials as well. This will help patients ferret out drugs that may be showing negative side effects.
This is a great resource, but does it have legs? Yes and no. The website does provide a way to obtain the data via XML feed, which would allow savvy programmers to mash it up with other information. However, you have to wade through several layers of the website to find instructions about how to do this. There’s also a page for webcrawlers. There is no way, as far as I could tell, to get this information in other formats, such as tab delimited file. On the front page, there are no links to RSS feeds or social media sites, such as Facebook and Twitter.
Are there third parties out there that are taking this information, mashing it up, and making it better? Yes. TrialCheck at Cancertrialshelp.org, a nonprofit group, takes data from ClinicalTrials.gov and other sources and takes it a step further, by avoiding dense medical terminolgy and giving users the option of calling a clinical trial specialist at the American Cancer Society for more information about a particular trial. Visits to the website quadrupled in the last year, reports the Los Angeles Times.
Another intriguing idea was submitted to Netsquared.org last year–a graphic designer proposed taking data on breast cancer and mashing it up with other information to produce maps for patients where they could quickly find local support groups, treatment, screening centers and events.
On my own wish list would be to figure out a way to take these data and mash them up with information about lawmakers’ districts, to see what drug trials are going on where. We already know that the pharmaceutical industry gives big bucks to federal candidates and parties and spends copiously on lobbying. Would lawmaker X be more likely to vote against stricter drug safety regulation if he has a big drug company sponsored trial going on in his district? Would it help explain why lawmaker Y is getting a flood of contributions from executives working with a particular out-of-district company? The data offered at ClinicalTrials.gov could help answer these questions.
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Read the Bill: Hurry to Pass Drug and Medical Device Law
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.
