Federal Times in the Right Area, but Doesn't Hit the Vein

Props to the Federal Times for an article by Rebecca Neal calling attention to the government's preparations for a pandemic flu outbreak, an issue that POGO has examined in some detail.  The story points out that Health and Human Services' (HHS) current plan is to vaccinate "20 million people deemed critical" in the case of an emergency.  What HHS has not done is tell the public, convincingly and in detail, who will receive the vaccinations and why.  In the event of an outbreak, an imperiled public would probably not be willing to listen to justifications as to why it cannot get help.

POGO agrees with the main point of Neal's article--that HHS needs to detail their plans for protecting the public.  That said, the government should disclose much more information relevant to a flu pandemic.  In a recent report, POGO lists documents that we think should be made readily available.  Among these are documents related to manufacturing capacity, dependence on foreign manufacturers, vaccine alternatives, and budget plans.  This issue is too important to be hidden deep within government files.  HHS needs to make the public aware of the safeguards it has in place, as well as its plans to manage crises of national (not to mention global) magnitude.

Click below to watch a video of POGO's Ned Feder discussing our investigation into the government's pandemic flu vaccine program:

-- Eric Orenstein

Conflicting Interests at FDA

On Monday, the Food and Drug Administration (FDA) formally announced new policies intended to increase transparency and public disclosure for its advisory committees.  Although a number of new policies were announced, the one creating the most buzz is the policy barring an advisor from participating in a meeting if the FDA determines that he or she has a financial interest of more than $50,000.  If the financial interest is less than $50,000, a waiver may be granted, but only if FDA officials "determine that there is an essential need for the advisor's particular expertise."

According to the FDA's press release, a financial interest would include "grants, stock holdings and contracts with a company that would be affected by the committee's recommendations."  A more detailed description can be found in the final guidance document.

The new policies are almost surely a result of the increased scrutiny of FDA advisory committees by the public and Congress.  The public outcry has been fueled by recent scandals in which members of FDA advisory committees vote to recommend drugs that they have a financial interest in, even when those drugs are likely to be harmful.

According to the Washington Post, "advisory committees play a central role in regulating drugs, medical devices and diagnostic tests.  Their decisions largely determine what drugs and medical products can be marketed to Americans--because the agency nearly always follows the panels' guidance."  If the advisory committees are as influential as the Post claims they are, the new policies may go a long way towards alleviating some of the influence that industry has on the FDA approval process.  But I'm not overly optimistic.

A 2006 report on FDA advisory committees by the National Research Center for Women & Families analyzed "the voting patterns and committee discussions of a random sample of 6 of 16 drug advisory committees and 5 of 18 medical device advisory panels" between 1998 and 2005.  The findings of the report seem to corroborate the tight link between advisory recommendations and FDA approval decisions.  Within the report's sample, all of the drugs and 94% of the devices recommended by advisory committees were subsequently approved by the FDA.

However, the report's findings also suggest that the influence of advisory committees may be overstated.  Astonishingly, 45% of drugs and 43% of devices that were not recommended by the advisory committees were approved by the FDA anyway.  If the advisory committees are as susceptible to industry influence as most people seem to think they are, and the FDA is approving drugs and devices that even the "corrupt" advisory committees won't recommend, what does that say about the FDA?

To be clear: I'm not arguing that advisory committees don't have a strong influence on the FDA approval process.  The new financial conflict of interest disclosure policies are certainly a step in the right direction.  But while it's easy to use the committee advisors as scapegoats, they are but one piece of an agency that is overly dependent on and sympathetic to the industry it is supposed to regulate.  With all the recent scandals, one almost gets the impression that industry is the FDA's true customer.  And as the old adage goes, "The customer is always right."

-- Jake Wiens

Tough Times at the FDA

It's hard to open a newspaper these days without reading a story about risky drugs with deadly side effects or salmonella-contaminated food.  It's no surprise, then, that the FDA has come under a great deal of scrutiny of late.  But simply blaming the agency for all the recent food and drug scandals doesn't take into account other complicating factors that have weakened government oversight in recent years.

On Friday, the AP ran a story about the food industry lobby killing a plan that would have required them to "maintain electronic tracking records that could be reviewed easily during a crisis to search for an outbreak's source," because it would have been too costly.  Of course, the business losses from the current outbreak are estimated to be about $250 million.  As the AP wrote, the recent outbreak of food borne illness in the U.S. "is teaching the food industry the truth of the adage, 'Be careful what you wish for because you might get it.'"

Also, while the FDA tends to get a lot of negative press when something it was supposed to regulate goes wrong, the blame can only go so far.  After all, the agency is responsible for A LOT.  Here's the FDA's mission statement:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

It's not only the responsibility of the FDA to ensure that everything you have ever put in your body is safe, effective, and innovative; they're supposed to educate you about it too.  That's quite the mission.  And while money doesn't guarantee effectiveness, one would expect that the FDA would be fully funded so that it could fulfill its mission.  But that's just not the case.

In February 2008, a panel of experts recommended that the FDA's budget be at least doubled by 2013.  Until those budget woes are effectively addressed, efforts to clean up the FDA's failures will result in resources being shifted to the scandal of the day, leaving the other FDA responsibilities vulnerable.

As POGO's Staff Scientist, Dr. Ned Feder, wrote in "Food and Drug Safety on the Cheap: It Can't Be Done," which was recently published in The Hill, without adequate FDA funding:

"...we should face the consequences squarely.  Incidents like those caused by salmonella, heparin, and Vioxx will happen again.  The FDA's perennial shortcomings will continue to claim human victims."

(Bonus: here's a video of FDA Commissioner, Andrew C. von Eschenbach, M.D., getting grilled about Heparin, the scandal that preceded the salmonella outbreak.  It's worth your time, trust me):

-- Jake Wiens

Aerosol Explosion Issue Heating Up Again

Over ten years ago, POGO issued one of the greatest investigative reports in modern history--EPA Finally Does The Right Thing: Public Safety Prevails Over Industry's Interests.  (You might laugh at my assertion, but there are "best of" lists for movies, sports teams, and songs, so I thought I would start lobbying for my work.)

POGO's report detailed the growing number of fires and explosions caused by aerosol products (including bug bombs, a.k.a. "foggers"), and the EPA's acquiescence to the aerosol industry when prompted by EPA scientists to change warning labels.  Eventually the EPA did the right thing, improving warning labels by providing more information, better directions, and graphic symbols to ensure bug bomb users were aware of the risks posed by aerosol products.  POGO was content with the EPA's actions, but we had hoped they would apply to all aerosol products.  At the time, POGO was able to document hundreds of reports by the Consumer Product Safety Commission on fires and explosions caused by many different types of aerosol products, not just bug bombs.

Now the issue is heating up again.  Reuters recently reported a case in which a man blew up his apartment while spraying for bugs.  The concern has always been that the propellants (including propane, butane, and isobutane) used to eject the other ingredients are very dangerous.  POGO interviewed a former NYC fire official who had collected numerous reports of fires and explosions caused by aerosol products and had testified in cases in which the aerosol users were on trial for arson.  There were a number of instances when bug bomb users were accused of dumping flammable substances in their homes and lighting them on fire.

Although I have not followed every aerosol fire and explosion case since 1998 or the results of the EPA's actions to regulate bug bombs, aerosol fires and explosions are still a problem deserving of more attention.  Heck, even Discovery's MythBusters confirmed the myth when its crew blew up a house a few years ago.

-- Scott Amey

P.S. Thanks to Peter Stockton, POGO's Senior Investigator, for his assistance and support on this topic through the years.

Pandemic Flu Vaccine Program: More Transparency Needed

In an op-ed piece published in yesterday's Federal Times, POGO's Ned Feder refers to an unreleased government document dated September 30, 2005, made available by the New York Times, in which officials describe a potential outbreak of pandemic flu spreading from a village in Asia to the United States:

Overall, about 2 percent of Americans with influenza illness die...Hospitals are overwhelmed...People riot at some vaccination clinics as they are turned away or supplies run out...Trucks transporting vaccine are hijacked...Public anxiety heightens mistrust of government...Mortuaries and funeral homes are overwhelmed...The majority of people still have not been vaccinated when a second wave of influenza begins.

A worst-case scenario to be sure, but as survivors of the 1918 pandemic flu can attest, the threat of an outbreak should not be taken lightly.  Yet under the government's current plan, a mass-produced flu vaccine is still years away.  Even if a pandemic hit the U.S., it would take an additional six months to make the vaccine available to everyone.

As Dr. Feder points out, one simple way to improve the government's flu vaccine program is to make more information available to the public.  For instance, if the government were to publicize its contracts with flu vaccine manufacturers, or disclose more information about its reliance on foreign sources of materials needed for vaccine production, program leaders could benefit from the input of health experts outside the government.  Yet these and other essential documents are not posted anywhere online.

POGO is calling for greater transparency in the pandemic flu vaccine program, so that government and health officials have the opportunity to learn about problems and possible improvements to the program before it's too late.      

For more information, check out our recent report on the government's pandemic flu vaccine program, or click on the video below.

-- Michael Smallberg

Pandemic Flu Still Poses Major Threat

At a meeting held Tuesday in Geneva, health experts from around the world discussed the serious threat posed by a flu pandemic, urging governments to plan now for a potential outbreak.  "We can't delude ourselves.  The threat of a pandemic influenza has not diminished," said Keiji Fukuda, coordinator for the World Health Organization's Global Influenza Program.

Scientists are particularly concerned about a recent strain of bird flu virus that could spread among humans, potentially leading to a full-blown pandemic.  Also, as Fukuda pointed out, some countries are woefully unprepared for an outbreak, with plans consisting of nothing more than a "piece of paper acknowledging the risk." 

Here in the U.S., Secretary of Health and Human Services Mike Leavitt has taken creative measures to prepare for a pandemic flu.  But POGO still has major concerns with the government's plan.  As we discussed in our recent report, Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program, the Department of Health and Human Services has neglected to recruit a permanent director for BARDA, a new agency tasked with facilitating collaboration between government, industry, and academia to develop a flu vaccine.  In addition, the government has failed to disclose some essential documents related to the flu vaccine program, such as contracts with vaccine manufacturers and the program budget.  Without public disclosure of these and other documents, government and health leaders might not learn about problems and possible improvements to the program until it is too late.

Click below to watch a video of POGO's Ned Feder discussing our investigation into the government's pandemic flu vaccine program.

-- Michael Smallberg

Pandemic Flu Vaccine: Government Program Needs a Booster Shot

The outbreak of pandemic flu in 1918 resulted in an estimated 50 million deaths worldwide; one writer has called it "the greatest medical holocaust in history."  In order to prevent a future outbreak, the U.S. is now racing to prepare for the mass production of an influenza vaccine.  But as POGO revealed in a report released last week, the government's vaccine program has been plagued by a lack of leadership and public disclosure, resulting in an unacceptably long time frame for vaccine production.

In 2006, Congress established the Biomedical Advanced Research and Development Authority (BARDA) in order to facilitate collaboration between leaders in government, industry, and academia on the flu vaccine and other programs dealing with public health emergencies.  However, the Administration has neglected to appoint a permanent director for BARDA, a situation that POGO's Ned Feder calls "inexcusable and dangerously short-sighted."

In addition, the government has failed to make publicly available some essential documents related to the flu vaccine program, such as government contracts for vaccine production and the vaccine program budget.  Without public disclosure of these and other documents, the government might not learn about problems and possible improvements to the program until it is too late.

POGO is calling on Congress to demand greater leadership and transparency for the flu vaccine program before another pandemic begins.  Otherwise, it looks like the government will be relying on a "pound of cure." 

-- Michael Smallberg

UPDATE: Click here to watch a video of Dr. Feder discussing his investigation into the government's pandemic flu vaccine program.

POGO Agrees with Activists: No Testing of Live Pathogens at Livermore

There are numerous problems with the Lawrence Livermore National Laboratory (LLNL) in Livermore,
California beginning work with deadly airborne pathogens such as anthrax, bird flu and West Nile virus in a new Biosafety Level 3 lab to test detection devices.

In terms of cost and safety, the fewer facilities in the world with these pathogens on-site the better. Because each pathogen has a distinct footprint that marks its origins, one problem with setting up another lab to work with these deadly pathogens is that it becomes harder to trace the source if one escaped, or is stolen.

Another reason for concern is that LLNL doesn’t have the best track record; the U.S. Department of Health and Human Services fined LLNL last year for releasing anthrax during a 2005 shipment.

POGO is currently working on a report on LLNL’s difficulty guarding its stash of plutonium and highly-enriched uranium, the most dangerous and expensive Special Nuclear Materials to protect from terrorists and thieves.

Also, it is a far from ideal location for such highly sensitive research projects. When the Livermore lab was established in 1952 it was out in the middle of nowhere. Today, due to sprawl from the Bay Area, 7 million people live within a 50 mile radius of the Lab, and with them senior centers, schools, and parks.

With homes only 300 yards from the fence line, some residents have been organizing against the introduction of hazardous and dangerous materials at the lab. "In the event of an accident, leak, spill or terrorist attack, this facility puts our lives at risk," said Marylia Kelley, executive director of lab watchdog group Tri-Valley Communities Against a Radioactive Environment (CARE), as reported in the Daily Californian.

Despite losing one lawsuit in court, Tri-Valley CAREs will file another injunction to block the Level 3 lab. Tri-Valley CAREs’ position is that the pathogens should stay at the Centers for Disease Control (CDC), and scientists should fly there to study them, as reported in The Oakland Tribune.

This “porkfest” of jobs and federal dollars for lab construction is symptomatic of what’s happening across the country, notes Edward Hammond with the nonprofit Sunshine Project. Yet with government handouts for construction – 36 WalMart-sized labs have been built since 2001 with 15,000 people authorized to handle the bioweapons - there are not similar handouts to protect the facilities. “I have a long-term fear that there will be an inadequate safety and security situation,” warns Hammond.

POGO recognizes that these pathogens need to be researched, BUT there are much better locales for this work to take place... like the already established Dugway Proving Ground in the middle of nowhere, Utah.  Where, drum roll please, the US military already does testing on chem/bio defense.  Why blow more funds in a densely populated area when you've already got a great place to do this work?

– Ingrid Drake & Nick Schwellenbach

Oversight Missing at the NIH

You might have missed it over the three-day weekend, but a report just released by the Inspector General of the Department of Health and Human Services reveals that the NIH (National Institutes of Health) is virtually in the dark when it comes to monitoring or regulating financial conflicts of interest among its research grantees.

As the report points out, 80 percent of the NIH's $29 billion budget is awarded to outside (or "extramural") research projects at universities and medical schools, and each of the grantee institutions must have a written conflict of interest policy. Yet the NIH cannot say how many conflicts of interest were reported by its grantee institutions between FY 2004 and 2006.  In 89 percent of the reported cases, the NIH had no information on the nature of the conflicts.

Even more alarming is that NIH officials are doing next to nothing to address the problem.  In fact, the NIH seems perfectly content letting the fox guard the hen house.  Dr. Norka Ruiz Bravo, the NIH's deputy director for extramural research, told the New York Times that the current system is "working to the extent that people are being honest, and I think most people are honest."  And Dr. David Korn, a senior official at the Association of American Medical Colleges, indicates that universities also favor the current practice of keeping detailed information about conflicts of interest under wraps within the walls of academia.  He told Science magazine that if the NIH follows the advice of the IG's report to amend the regulations, "the universities would fight extremely hard to not let that happen."

Some have argued that adding more oversight at the NIH would create an unnecessary layer of bureaucracy. But given the large number of NIH-funded researchers who also accept (and often fail to report) income from pharmaceutical companies and other private interests, it seems irresponsible to rely on grantees to disclose their own conflicts of interest.  As POGO's Ned Feder told The Scientist, "There are too many examples where this self-policing has been abused."  Feder also noted that the recommendations made in the IG report are "the minimum that is needed to deal with conflicts of interest."

Stay tuned over the next few weeks, as POGO will be issuing its own recommendations for strengthening oversight at the NIH.

-- Michael Smallberg

FDA – Failing the Grade

On July 17th, the House Committee on Energy and Commerce held a hearing regarding the Food and Drug Administration’s (FDA) food safety inspection program. Specifically, the sub-committee on Oversight and Investigations wanted to know if FDA has the capacity to secure the safety of the country’s food supply. When asked to rate the performance of the FDA in this crucial task, none of the FDA agency employees gave more than a 5, with 1 being the lowest and 10 being the best.

But what is more alarming than this assessment is FDA’s response to internal criticism. Two days after the hearing, Margaret Glavin, the assistant Commissioner of FDA’s Office of Regulatory Affairs (ORA), issued this office-wide email (pdf) criticizing the witnesses. In the email, Ms. Glavins seem to suggest that somehow the witnesses’ testimonies have somehow undermined and discredited the work of the entire agency. In addressing the email to her staff, she says: “I know that many of you were disappointed, and perhaps even angry, at this erroneous assessment.”

Never mind the fact that these witnesses were required to give their opinions under oath, but even if their assessment were “inaccurate”, shouldn’t Ms. Glavins make a case for her position instead of trying to pit these witnesses against their colleagues? And if their assessment is indeed accurate, then Ms. Glavins has much more important things to do than go after employees that make the agency look bad.

Rep. Dingell (D-MI) and Rep. Stupak (D-MI) have already sent a letter (pdf) to FDA Commissioner Andrew von Eschenbach to take disciplinary action against Ms. Glavins.

It is sad to see senior officials create agency in-fighting when they should be focusing their attention on the real problem at hand: protecting our food supply.

-- Michael Zhou