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.

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

Contagious Crossings

The multiple crossings into this country by a Mexican citizen with a highly-contagious form of tuberculosis continue to raise concerns.  Senate Homeland Security and Government Affairs Chairman Joe Lieberman (I-Conn.) and Ranking Member Susan Collins (R-Maine) are not about to let up on the Homeland Security Department.  Last week during a hearing on terrorist watch lists Collins in particular made clear she was not satisfied with the responses to her questions about the case from department official Paul Rosenzweig.  Now they have fired off a letter to Secretary Michael Chertoff demanding he respond by November 6th to a rather daunting list of 31 questions surrounding the case of Amado Isidro Armendariz Amaya, who has been diagnosed with multi-drug resistant tuberculosis (MDR-TB). 

In their cover letter they point out that Amaya “was allowed to repeatedly enter the U.S. between April 16 and May 31, 2007, despite a lookout being placed in the CBP computer-based screening system for him."  Furthermore they write that: 

We are troubled by the slow release of information to our Committee from the Department about the Amaya case, some of which has proven to be contradicted by other government sources.  In particular, we are concerned that the Department claimed to have originally received only an alias for Mr. Amaya, but later reported that it received a complete last name and middle name for him.  Furthermore, DHS officials reported that they could not provide the Committee with information about the flights that Mr. Amaya took within the U.S. after DHS was alerted to his health status.  The CDC, however, stated that it had received Mr. Amaya’s flight information from the Office of Health Affairs at DHS.   We expect to receive complete and accurate information on this case in a timely manner.

The letter also points out that during the same time period, Department officials were:

...briefing Congress on the case of Andrew Speaker, an American who was also infected with MDR-TB and who was also admitted to the U.S. despite CBP having placed a lookout for him in their computer-based screening system.  During the week of June 4, 2007, personnel from the Department, including the Chief Medical Officer and CBP who were involved in both the Amaya and Speaker cases, briefed the Committee on the vulnerabilities in our border systems that allowed Andrew Speaker to re-enter the U.S undetected.  However, no one from DHS alerted the Committee of the Mexican national who had entered the U.S. undetected 21 times in the seven prior weeks.   We find it troubling that no one from your Department thought it prudent to advise the Senate of the Amaya case at the time that the Committee was investigating the vulnerabilities that allowed another person with MDR-TB and on a watch list to enter the U.S. undetected.

“Troubling” …. is that a polite way of saying “we’re mad as hell”?

-- Beverley Lumpkin

A Fishy Revolving Door?

Linda Fishman, recently the director of the Office of Legislation for the Centers for Medicare and Medicaid Services, begins work at the American Hospital Association on Monday as their new vice president of legislative affairs.  Fishman has also worked for the Senate Finance and House Ways and Means committees and the Association of American Medical colleges.  Ethics rules prohibit Fishman from dealing with her former colleagues at the Centers for Medicare and Medicaid Services for one year.

-- Mandy Smithberger

Just Flu It

I attended a House Government Reform Committee hearing today on avian flu pandemic preparedness.  Among many points of discussion, the issue of Tamiflu stockpiling and production stood out.  No one knows how effective Switzerland-based pharmaceutical giant Roche's Tamiflu antiviral drug will be if and when bird flu mutates and becomes a human-to-human transmissible virus, but it's widely agreed that it's the one of the most effective antiviral drugs in production that can help deal with a pandemic.  The problem is that there isn't enough Tamiflu and, given Roche's production capacity, there won't be enough to cover 25-40% of the population for up to ten years if a pandemic hits.  Currently the US only has enough Tamiflu to cover 1-2% of its population.

A main point of contention over Tamiflu was over whether the Secretary of Health and Human Services should compel Roche to license its drug to other companies to ramp up production.  Rep. Dennis Kucinich (D-OH) railed against Roche and asked HHS Secretary Michael Leavitt if he would use his authority to force compulsory licensing.  Leavitt said he did not think it was needed and believed if he compelled Roche to license its drug, that there would be "no new drugs" (implying that companies wouldn't engage in the risk of research and development if their intellectual property rights and thus profits were seen to be in danger; I'll address this in a bit).

Rep. Dan Burton (R-IN) continued this line of questioning, asking if Leavitt would use his authority in an emergency situation.  Leavitt finally said, "We'll do whatever it takes."  Burton asked if that meant a "yes," and again Leavitt ambiguously said "whatever it takes."

Regarding the intellectual property argument Leavitt invoked, it's pretty weak on several counts.  First, compulsory licensing only should be used in the case of a public health or national security emergency.  So such authority would rarely be used.  Second, the company whose intellectual property rights are violated in the case of significant public interest would be compensated.  As long as the compensation is fair (which is subject to interpretation depending on who's side you're on, the taxpayer or the company), the company won't "lose" out too much. 

Yet the best reason for Leavitt to say that he would force licensing in an emergency situation, besides actually leaving open the option to increase production if need be, is that publicly stating that the United States government would consider that option will help push Roche to license its drug to other companies voluntarily without having to be forced to do so.

--Nick Schwellenbach

MORE: GoozNews has James Love of the Consumer Project on Technology's response to the government's position.