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

A Biodefense Breakfast

It was biodefense wonkfest hour today at the breakfast briefing on the 2006 biodefense legislative agenda held by the DC Office of the Monterey Institute. Speaking were Robert Kadlec and David Bowen, Majority Staff Director of the US Senate Subcommittee on Bioterrorism and Public Health Preparedness, and Minority Staff Director for Health Policy on the US Senate HELP Committee respectively. Here are some of the more interesting moments for POGO's Nick Schwellenbach who attended the event.

Almost as an aside, Kadlec discussed how the Constitution (Kadlec even pulled out a pocket Constitution as a prop) mentions nothing about public health or preparedness for biological threats, be they natural or intentionally created. Yet that doesn't mean we shouldn't prepare, since, for example, "an accidental release of SARS from a lab" might lead to a breakdown of order across the nation. At least implicitly, this statement acknowledges that the hundreds of labs across the nation and the world that work on deadly and/or highly infectious pathogens are a potential risk in themselves. In fact, there have been outbreaks of SARS that have stemmed from labs working on the disease. And, as noted on this blog, there have been numerous accidents at labs doing biodefense work. Such work has grown exponentially in the last several years, leading many to believe that more accidents will occur.

Later on, Alan Pearson of the Center for Arms Control and Non-Proliferation asked if the biodefense legislative agenda addressed the subject of research oversight given that a number of biodefense projects involve making pathogens or toxins more powerful, resistant to current forms of treatment or some other modification that increases their threat. Bowen said that the Recombinant DNA Advisory Committee was possibly a useful model to emulate.

Related to the issue of oversight is the transparency of the government's biodefense efforts. The proposed Biomedical Advanced Research and Development Agency (BARDA) came up numerous times in the briefing. Kadlec said that the language exempting BARDA from the Freedom of Information Act would be narrowed to exempt only particular kinds of information, not the agency as a whole.

At a meeting with open government advocates in December, Kadlec said essentially the same thing. But, as Edward Hammond of the Sunshine Project has noted, when you take a look at the information that Kadlec is considering exempting, there would still be excessive secrecy at BARDA.

According to the second page of these slides (pdf) provided by Kadlec in December, "language might be added to the bill stating that there shall be no unauthorized disclosure of information produced or obtained in conjunction with activities pursuant to, or in implementation of, subsections _______ of this section." Candidate sections of the BARDA bill that may be covered by the new (b)(3) exemption to FOIA are "(b)(2) (p. 92); (b)(4)(A)-(C) (pp. 93-99); (b)(4)(E)(ii) (p. 100); (c)(2) (p. 108)." These candidate sections cover a vast spectrum of BARDA's activities.

These are the sections of the bill that could end up having their pertinent records exempt from FOIA:

(b)(2) (p. 92): (2) It shall be the purpose of the BARDA to coordinate and oversee activities that support and accelerate qualified countermeasure or qualified pandemic or epidemic product (referred to in this section as `countermeasure or product') advanced research and development by...

(b)(4)(A)-(C) (pp. 93-99): (4) DUTIES OF DIRECTOR-

`(A) COLLABORATION- To carry out the purpose described in paragraph (2)(A), the Secretary, acting through the Director, shall--

`(i) increase appropriate communication between the Federal Government and relevant industries, academia, and other interested persons with respect to countermeasure and product advanced research and development by establishing transparent, expeditious, and direct processes to--

`(I) facilitate regular, ongoing communication regarding the processes established under subparagraph (C)(ii) and new countermeasures or products of interest;

`(II) solicit research and associated data on potential countermeasures and products and related technologies; and

`(III) provide technical assistance with respect to such processes and the Food and Drug Administration approval process;

`(ii) at least annually--

`(I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies, and other interested persons; and

`(II) sponsor relevant biodefense countermeasure technology demonstrations;

`(iii) carry out the activities described in subsection (g) of section 2 of the Clayton Act; and

`(iv) encourage and coordinate countermeasure or product advanced research and development, including by convening working groups as identified in paragraph (5).

`(B) SUPPORT ADVANCED RESEARCH AND DEVELOPMENT- To carry out the purpose described in paragraph (2)(B), the Secretary, acting through the Director, shall--

`(i) conduct continuous searches and support calls for potential countermeasures or products for drugs, biological products, devices, or research tools to diagnose, mitigate, prevent, or treat harm from existing, emerging, or possible chemical, biological, radiological, and nuclear agents or potential pandemic infectious diseases that threaten public health and national security, as identified by the Assistant Secretary for Public Health Emergency Preparedness;

`(ii) direct the countermeasure and product advanced research and development activities of the Department of Health and Human Services, in consultation with the Assistant Secretary for Public Health Emergency Preparedness, the Director of the National Institutes of Health, the Director of the Centers for the Disease Control and Prevention, and the Commissioner of Food and Drugs; and

`(iii) award contracts, grants, cooperative agreements, and enter into other transactions, to include use of simplified acquisition authorities provided under sections 319F-1 and 319F-2(c)(7)(C)(iii), to public and private persons, including for-profit and nonprofit persons, federally funded research and development centers, and universities, to--

`(I) support the cost of countermeasure and product advanced research and development; and

`(II) ensure accelerated development of countermeasures and products.

`(C) STREAMLINE PROCESSES- To carry out the purpose described in paragraph (2)(C), the Secretary, acting through the Director, shall--

`(i) receive from the Assistant Secretary for Public Health Emergency Preparedness, requirements for national civilian biodefense needs, particularly countermeasures or products and other technologies, to diagnose, mitigate, prevent, or treat harm from existing, emerging, or potential chemical, biological, radiological, or nuclear agents (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) or potential pandemic infectious diseases;

`(ii) establish transparent, expeditious, and direct processes for selecting promising countermeasures and products, supporting them through advanced research and development and recommending them for procurement;

`(iii) establish an office within the BARDA, in consultation with the Commissioner of Food and Drugs, to--

`(I) facilitate regular and ongoing communication between the BARDA and the Food and Drug Administration regarding the status of BARDA advanced research and development activities;

`(II) ensure that such activities are coordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and approval of countermeasures and products; and

`(III) connect interested persons with additional technical assistance made available under section 565 of the Federal Food, Drug, and Cosmetic Act;

`(iv) coordinate with the Food and Drug Administration to facilitate regulatory review and approval of promising classes of countermeasures or products through the development of research tools; and

`(v) recommend to the Secretary, through the Assistant Secretary for Public Health Emergency Preparedness, procurement of the most promising eligible security countermeasures or qualified pandemic or epidemic products identified in clause (i).

(b)(4)(E)(ii) (p. 100): (ii) SECRETARY DUTIES- The Secretary, acting through the Director, may--

`(I) enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary to carry out the functions of BARDA, without regard to section 3648 and 3709 of the Revised Statutes of the United States (31 U.S.C. 3324(a) and (b), (41 U.S.C. 5), with any public agency, any firm, association, corporation, or educational institution, or any other person;

`(II) support advanced research and development and innovation of potential countermeasures or products by highly qualified foreign national persons outside the United States that may inure to the benefit of the American people and collaborative research involving American and foreign participants;

`(III) administer grants using milestone-based awards and payments; and

`(IV) establish 1 or more federally funded research and development centers or university affiliated research centers in accordance with section 253(c)(3) of title 41, United States Code.

(c)(2) (p. 108): (2) DUTIES- The Board shall--

`(A) advise the Secretary on major biodefense initiatives and review ongoing and proposed biodefense programs, which may include potential activities of the BARDA; and

`(B) in consultation with the Director of BARDA, and in coordination with the Director of National Institute of Allergy and Infectious Diseases, provide to the Secretary, recommendations and findings for an expanded, intensified, and coordinated biodefense research program encompassing the programs of the BARDA and other Federal agencies and related programs of the other research institutes.

Unseen Vaccine

Is the Department of Defense (DoD) underreporting adverse neurological effects from smallpox vaccine?  Merrill Goozner of the Center for Science in the Public Interest thinks that's the case.  It looks like he might be onto something. 

A recent study using results from the Vaccine Adverse Effects Reporting System found that Department of Health and Human Service (HHS) employees accounted for over half the adverse effects reports, while DoD employees were cited as suffering from slighly less than half--despite the fact that about 9 times as many DoD employees than HHS employess were administered the smallpox vaccine. 

From the Journal of the American Medical Association (JAMA) abstract of "Neurologic Adverse Events Associated With Smallpox Vaccination in the United States, 2002-2004" (Vol. 294 No. 21, December 7, 2005):

Design and Setting  We assessed reports of adverse events obtained through active case reporting and review of data reported to the Vaccine Adverse Event Reporting System among 665 000 persons vaccinated against smallpox by the Departments of Defense (n = 590 400) and Health and Human Services (n = 64 600) during the 2002-2004 US Smallpox Vaccination Program.

[snip]

Results  Between December 16, 2002, and March 11, 2004, 214 neurologic adverse events temporally associated with smallpox vaccination were reported; 111 reports involved Department of Health and Human Services and 103 involved Department of Defense vaccinees.

The smallpox vaccine has been controversial, as has the anthrax vaccine. 

This summer POGO discovered a "missing link" to anthrax vaccine adverse effects information that was removed from a Food and Drug Administration webpage. 

The anthrax vaccine in question has been used by the DoD to inoculate troops.  Recently up to half of troops asked to take the anthrax vaccine have refused it and some sources have told POGO that the military has been underreporting adverse effects from the anthrax vaccine.  According to a series on the anthrax vaccine in the Daily Press, the military has withheld data on "more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine."

BARDA: A Breeding Ground for Another Brownie?

Effects Measure (a public health policy blog anonymously run by public health experts) thinks that the secretive Biomedical Advanced Research and Development Agency (BARDA) proposed by Senate bill 1873 will be a breeding ground for another Mike Brown because there will be little transparency in the agency.

BARDA will coordinate efforts to research and develop medical countermeasures to pandemic or terrorist biological events.  Brown (or "Brownie" as Bush refers to him) was the incompetent crony ex-Arabian horse judge in charge of FEMA during the Katrina disaster.  BARDA, as the legislation creating it currently stands, will be effectively exempt from the Freedom of Information Act (FOIA) and Federal Advisory Committee Act (FACA).

In another post, Effects Measure asks:

...without oversight, how will be know if guidelines are being followed and good faith pursued [in BARDA]? We'll just have to trust everyone concerned: the drug companies, the public officials, the drug company execs who are former public officials, the public officials who are used to be drug company execs.

Judging by the government's track record so far from the response to Katrina to bioterrorism preparedness, the public has good reason not to trust the government.  Keeping BARDA's activities under wraps and saying "trust us" might defer some negative newspaper articles for a while, but it won't make the agency more effective.  Transparency and the pressure that comes from public scrutiny will keep the government working better than it would in secret.

Cloaking BARDA

There's a good AP story out today on the proposal to exempt an entire new government agency from the Freedom of Information Act (FOIA) and the Federal Advisory Committee Act (FACA).  We were among the first to call foul on anti-accountability aspects of the legislation (S. 1873) that creates the Biomedical Advanced Research and Development Agency, or BARDA. 

A blanket FOIA exemption for an entire is unneeded, goes too far and is bad public policy that could backfire and lead to waste, fraud, abuse and slower scientific and medical progress from a lack of accountability and flow of information.  Furthermore, no other government agency has such an exemption, not even the CIA or other intelligence agencies.

Though some supporters of the FOIA exemption say the agency will still respond to FOIAs that don't threaten national security--there is already an exemption for that information.  Likewise, it is a false argument when supporters say the agency exemption is necessary because proprietary information could be released through FOIA since there is already an proprietary information exemption to FOIA.  In sum, FOIA already has exemptions for information that shouldn't be released. 

The two biggest problems with the BARDA legislation, sometimes refer to as Bioshield 2, are that, one, the language creates the impression that there will be a presumption of non-disclosure for things that could even be disclosed and, secondly, that there is no judicial review.  Mark Tapscott of the Heritage Foundation eloquently addresses the lack of judicial review problem in a recent op-ed.

The section of the bill that addresses FOIA and FACA is titled "Inapplicability of Certain Acts." The actual language on FOIA is as follows:

`(1) FACA- The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the duties, activities, working groups, and advisory boards of the BARDA.

`(2) FOIA- Information that relates to the activities, working groups, and advisory boards of the BARDA shall not be subject to disclosure under section 552 of title 5, United States Code, unless the Secretary or Director determines that such disclosure would pose no threat to national security. Such a determination shall not be subject to judicial review.

Words and phrases such as "inapplicability" and "shall not be subject to disclosure" give the impression that transparency will be the exception, rather than the rule.  This could easily be changed by either removing this section entirely (remember FOIA already contains exemptions for information that should be withheld) or by inverting some of the language ("inapplicability" to "applicability" and "shall not be" to "shall be").

Cloaking an entire agency in secrecy sets a dangerous precedent which could lead to ever greater secrecy across the government.

Checking the Pulse of EMP

The Washington Time's Bill Gertz's account of the threat of an electromagnetic pulse (EMP) attack in his piece “U.S. seen vulnerable to space 'pulse' attack” relies on hype and distortion. Though EMP is a real effect of nuclear detonations and can wreak havoc on electrical systems and electronics, it would be difficult for terrorists to pull off. And nation-states that would attempt such an attack would face nuclear retaliation from the United States which, during the Cold War, shielded its nuclear command and control systems from the possibility of EMP effects from an exchange with the Soviet Union.

There is a significant factual error in the Gertz piece. Gertz notes that "North Korea sells its own version of the Scud for around $100,000." As Steven Zaloga, a missile expert at the Teal Group Corporation and author of the book "The Scud," told POGO's Nick Schwellenbach for an article he wrote in The Bulletin of the Atomic Scientists this fall (paid subscription req'd), "A price of $100,000 for a Scud might refer to a non-working training model, but not a functional weapon." Zaloga is unsure what the going rate for a North Korean extended-range Scud would be, but a baseline Russian-made Scud (which are no longer made) would cost between $1 million and $2 million alone. The cost of the launch system would cost significantly more.

If terrorists did manage to build a nuclear weapon it is highly improbable that they could produce an efficient EMP-producing nuclear weapon, according to nuclear physicist Richard Garwin, who also published one of the first theoretical papers on EMP. Philip Coyle, former Pentagon director of operational test and evaluation, emailed Global Security Newswire that even "the U.S. military does not know how to [create thermonuclear-scale EMP from a Hiroshima-sized weapon] today, and has no way of demonstrating the capability in the future without returning to nuclear testing." When the United States does not have this ability, needless to say, it's unlikely that terrorist or "rogue" states could easily accomplish such a technological feat. It is much more likely that terrorists would build a relatively low-yield improvised nuclear device (smaller in magnitude than the bomb dropped on Hiroshima, yet still devastating if detonated in a city).

States could assist terrorist groups in achieving an EMP attack, but this scenario still runs into the technological hurdles of producing a nuclear weapon that could produce significant amounts of EMP. Without such a Super-EMP weapon a terrorist group could not hope to impact a vast swath of the continental US with one weapon detonated at high altitude.

EMP is definitely a factor to consider in conflict scenarios of a war with China over Taiwan since China has thermonuclear weapons and Taiwan covers a much smaller geographic area than the US (this is the scenario noted in “The Military Power of the People's Republic of China 2005” (pdf) that Gertz cites as the “recent Pentagon report”). But more scrutiny should be given to scenarios of an EMP attack on the United States by terrorists before we spend the $20-200 billion dollars the EMP Commission estimates the US spend to harden its critical infrastructure from such an attack.

A Taste of Their Own Medicine

As drugs like Vioxx and Bextra are pulled from the market, the FDA has come under increasing fire for its ties to the industry and for turning a blind eye to unfavorable data.  As it turns out, Propulsid, another lucrative drug with a questionable safety record, was given a VIP-worthy escort through the FDA’s safety review process.

So what’s being done to eliminate this industry-government coziness?  On Wednesday, the House approved a bill sponsored by Maurice Hinchey (D-NY) that would regulate financial conflicts of interest in the FDA.  The bill has gone to the Senate, where it will be reviewed by the Senate Committee on Health, Education, Labor, and Pensions.

Senators Chuck Grassley (R-IA) and Christopher Dodd (D-CT) have also submitted to the committee a pair of bills together (the Fair Act to Clinical Trials Act 2005 and the FDA Safety Act) that would reform the FDA and increase transparency.  In an effort to eliminate conflicts of interest, the FDA Safety Act would restructure the organization so that the safety division would no longer be a part of its drug approval division.

Committee Chairman Mike Enzi (R-WY), however, has been busy crafting his own legislation with Edward Kennedy (D-MA).  The problem is, Enzi has said it’s unlikely his bill will call for an independent drug safety board.

Yet this is a critical problem facing the FDA.  In May, the FDA proudly announced the creation of the Drug Safety Oversight Board (DSB) to “provide oversight and advice to the Director of FDA's Center for Drug Evaluation and Research (CDER) on the management of drug safety issues.”  Unfortunately, the DSB is so mired in conflicts of interest that FDA Safety Officer David Graham said “drug safety in the U.S. is worse off today than it was in November [2004]” (see the Washington Post article). 

When 11 of the 15 seats on the DSB are filled by senior managers of the CDER, the board responsible for reviewing the drugs in the first place, we’re not off to a good start.

According to FDA Week, Enzi is reluctant to create an independent drug safety board because it “would make it difficult for FDA to properly balance a drug's risks and benefits.”  An Enzi aide also confirmed that the senator was concerned a separate board would place too much emphasis on a drug’s risks.  Isn’t that the idea? 

U.Alabama settles with DOJ

The Justice Department announced today that the University of Alabama-Birmingham will pay the US government $3.39 million in response to allegations that the university violated the False Claims Act:

The settlement resolves allegations that the university misled the National Institutes of Health and other sponsors of federally-funded grants, as well as the Medicare program, into paying more money than the school was lawfully entitled to receive. The government alleged that in completing applications for federal health science research grants, the school overstated the percentage of work effort that the researchers were able to devote to the grant. It was also alleged that the university, and the entity through which its medical school faculty provide clinical services, unlawfully billed Medicare for clinical research trials that were also billed to the sponsor of research grants.

Two university whistleblowers brought these concerns to light.

Healthcare is big business and universities play an integral role.  And although we don't usually realize it, universities have a profit motive, according to Jennifer Washburn, author of the new book University Inc: The Corporate Corruption of Higher Education.  Washburn told POGO:

...universities themselves are acting much more like for-profit institutions. The real historical shift can be traced pretty clearly to the Bayh-Dole Act, which the US Congress passed in 1980, which gave universities automatic intellectual property rights to taxpayer-financed research.
...
The problem was that it introduced a profit motive into the heart of the university that was very distinct from anything what we had seen previously. Universities have long had relationships with private industry—professors consulted for industry, graduates took jobs in industry—but never before was the university itself trying to profit off of campus-based research. And so that’s the real change that happened in 1980.

UCS: Restore scientific integrity

This Wednesday the Union of Concerned Scientists chair Kurt Gottfried issued a statement calling for the return of "scientific integrity in policy making."  The brief statement says "decisions about science-related policies [should] be based on facts" and that scientific conclusions should "not be suppressed or misrepresented."

UCS has noted that advisory panels on issues such as Arms Control and Bioethics have been dismissed or meddled with and scientific conclusions--when at odds with the Bush administration party line--are often quashed.  A report last year by the House Government Reform committee's minority office raises similar concerns.

In related science news, GovExec reports that the Park Service Advisory Board has called for better science (i.e. more resources devoted to science research) at the National Park Service.  At least some have linked purportedly weak science at NPS with the Bush administration.  According to Howard McCurdy, NPS volunteer and professor of public administration with expertise in science policy at American University, "The Bush administration has not emphasized science ... to the same extent that has occurred under previous administrations, both Republican and Democratic."