BIOTERRORISM: $1billion effort yields no bioterror defenses

Bryan Bender : Globe Staff / January 17, 2011

WASHINGTON — The Pentagon is scaling back one of its largest efforts to develop treatments for troops and civilians infected in a germ warfare attack after a $1 billion, five-year program fell short of its primary goal.
 Even the heavy infusion of research cash and a unified effort by university labs and biotech companies from Boston to California were insufficient to break through limitations of genetic science, according to government officials and specialists in biological terrorism.
Instead, the Pentagon’s next $1 billion for the Transformational Medical Technologies program will focus on better ways to identify mutant versions of Ebola, Marburg, and other deadly viruses. Those are among the genetically modified agents that officials fear could be used by terrorists or rogue states against urban or military targets.
The continued flow of money, even with the shift in strategy, should help Massachusetts and other states retain jobs and research labs focused on this arena.
“There is tremendous potential for further development of a biodefense subcluster in the state,’’ said James D. Rooney, vice president of the Massachusetts High Technology Council.
Among Bay State firms that have received contracts under the germ warfare effort is Worcester-based Microbiotix. Representatives from Microbiotix did not respond to requests for comment.
The new strategy represents a return to the drawing board for an ambitious program conceived after the Sept. 11 terrorist strikes and subsequent mailing of anthrax to members of Congress and media organizations — events that helped US military planners realize that the nation lacked adequate defenses against bioterrorism.
Scientists initially set out to develop new medicines capable of attacking viruses that might be altered by terrorists to make them more deadly. But after more than 50 research projects by more than 100 contractors — including biotech firms, pharmaceutical companies, and universities, including several in the Boston area — only two experimental medicines have shown promise. And even those are far from being ready for limited clinical tests, according to project officials.
“They are trying to come up with new medical technologies that are more difficult to develop,’’ said Crystal Franco, a specialist at the Center for Biosecurity at the University of Pittsburgh Medical Center who specializes in biological defense policy. “They are really trying to push the envelope.
Another hurdle in the government’s effort: such treatments cannot be tested in human clinical trials, which are typically required for Food and Drug Administration approval, because it is unethical to expose people to deadly virus in such a study, requiring animals with similar traits as humans to serve as surrogates.
Alan S. Rudolph, director of science and technology at the Defense Threat Reduction Agency, said in an interview that the agency will now focus more attention on ways of identifying new pathogens. That research could lay the groundwork for further advances in the development of antidotes that could eventually win FDA approval.
The new focus of the program will be making a “cadre of investments that are able to take an unknown sample that may contain different agents, and be able to determine very quickly what is in there,’’ Rudolph said. “It is our intent to continue to grow this capability.’’
He added the ultimate goal will still be to someday develop therapeutic remedies that could treat someone infected with any number of deadly viruses — what the Pentagon called “one size fits all’’ or “one drug, many bugs.’’
In addition to Ebola and Marburg, some of the potential biological threats on the Pentagon’s target list are Lassa, Sabia, Machupo, and Junin, especially modified versions designed to cause more severe symptoms of hemorrhagic fever that are more resistant to traditional drugs.
The difficulty in developing medicines so far, however, demonstrates how much more research is needed, say biological warfare specialists.
It turns out it is easier to modify a germ or virus for an offensive threat than it is to develop an effective defense, they said.
“The offensive capabilities outrun the defensive capabilities as the march of biology continues,’’ said Richard J. Danzig, a former Navy secretary and noted expert on bioterrorism who sits on the Pentagon’s high-level Defense Policy Board.
“The theory behind [the program] was these same advances should empower the defenses,’’ he said. “I think that intuition is worth exploring and investing in, but it is easier to conceive than to execute.’’
Margaret Kosal, an assistant professor at Georgia Tech who worked on the program between 2006 and 2007, said “there is a fundamental need for basic science. The low-hanging fruit has all been picked.’’
One Pentagon contractor involved in the program who was not authorized to speak publicly put it more bluntly: “We’re years away from any reasonable FDA certification, let alone production.’’
Franco said the project’s hurdles also highlight the need for ongoing taxpayer-investment commitments from government, to encourage private-sector focus on such technologies that will generate little in sales, compared to, say, cholesterol and diabetes treatments.
“These are not going to be blockbuster drugs,’’ said Franco. “It is different when the government is your only market. There needs to be incentives for companies to participate, to take it on for the public good.’’
http://www.boston.com/news/nation/articles/2011/01/17/after_1b_spent_pentagon_shifts_strategy_on_bioterror_threats/?page=full

POVERTY: Genetically Engineered Food: Are GMOs Safe?

Paul Tullis December 14, 2010
The most profound innovation to come to many crops in the last generation -- and one of the most widespread -- is genetic engineering. The cultivation of corn and soy today is so scientifically and technologically advanced it would be unrecognizable to a farmer just 40 years ago.
Eighty percent of the 86 million acres of corn planted in the United States today -- as well as 92 percent of the soy, and a good deal of the squash, tomatoes, potatoes, canola and a host of other crops -- comes from genetically engineered, or "GE," seed. Yet despite these crops' ubiquity, 60 percent of Americans don't even know they're eating GE foods.
Even before GE crops were introduced in 1996, debate raged among scientists, farmers, environmentalists and public health officials and academics regarding their safety, with pro and con sides finding little common ground.
"There's now overwhelming evidence that GE foods are unsafe and should never have been introduced," says Jeffrey M. Smith, author of self-published books purporting to show just that.
"Foods derived from biotechnology have been eaten by billions of people without a single documented health problem," counters Sharon Bomer Lauritsen, Executive Vice President for Food and Agriculture of BIO, the lobbying arm of the biotech industry.
It's difficult to find a scientist knowledgeable on the topic who doesn't have financial ties to the biotechnology industry, and it's equally challenging to find an opponent of GE who seems capable of recognizing its potential and doesn't object to the technology per se.

So what's the deal? First, some background:
GE seed contains a gene from a different organism in its DNA, giving the plant it produces desirable traits. Although the biotechnology industry has long promised nutrient-rich and drought- and frost-resistant crops to alleviate hunger and malnutrition among the world's poor (any day now, we're told), the overwhelming majority of GE seed today is modified to tolerate certain pesticides and herbicides -- which in many cases are made by the same companies selling the patented seeds. For instance, St. Louis-based agrochemical giant Monsanto makes Roundup Ready® soy, which is resistant to a pesticide Monsanto sells, enabling farmers to virtually drown their crop in the synthetic chemical. The result is that Roundup® is the most popular agricultural pesticide in the Unites States.
Claims by manufacturers that this makes farming more economical and better for the environment by reducing both the amount of work that goes into the crop, and how much farmers have to spray, are supported by august bodies of science, though some studies place doubt on those findings.
Smith's anti-GMO claim is contradicted by the National Academy of Sciences in the Unites States as well as the UK's leading academy of medical science, the Royal Society of Medicine.
Lauritsen's claim, however, is unsupportable because the absence of evidence is not evidence of absence. Proving safety would require a massive, longitudinal epidemiological study with a control group that has never been exposed to GE foods, which may be well-nigh impossible given that the GE toothpaste is out of the tube: GE seeds migrate into fields of non-GE varieties, so they are virtually impossible to avoid.
Which makes the possible hazards to human health and the environment from GE foods disturbing to some. Alteration of the DNA of GE foods carries the potential to turn them toxic or cause allergic reactions, and their use may actually have led to an increase of spraying of harmful chemicals into the environment.

European nations have even banned GE foods in response to public outcry.
Who is responsible for ensuring that agricultural products are safe for human consumption and the environment?
Should the government commission independent scientific analysis to ensure safety of GE crops to human health and the environment? Should companies be trusted to make their products safe, suffering civil damages if they're later proven otherwise? Or should consumers be left to fend for themselves?

GE crops in the United States are approved for use by either the Agriculture Department, the EPA, or the FDA, each with its own process.
Bill Freese, science policy analyst at the Center for Food Safety, says the government needs "to improve the regulatory system, which is a rubber stamp designed to enhance public confidence without ensuring safety."
BIO's Lauritsen, meanwhile, "supports the current U.S. regulatory framework," saying "biotech crops go through extensive testing and review."
But Gregory Jaffe, a lawyer who is director of biotechnology projects at the Center for Science in the Public Interest, says "that's misleading. The FDA has a voluntary consultation process, which I think is inadequate." (We've seen what self-regulation has done to financial markets and the waters of the Gulf of Mexico.) The USDA, Jaffe says, does "a fairly good job of ensuring it doesn't have an impact on agricultural interests, but the process to [minimize] environmental impact is inadequate." Jaffe rates the EPA tops at ensuring against food safety risk of the crops it oversees, which includes all that corn.

Bottom line (keeping in mind that I am neither doctor nor scientist):
For the small percentage of the population that's extremely food-sensitive or has severe allergies, it's probably best to avoid GE foods when possible. That means buying organic anything containing corn, soy, or canola (check your labels -- you'll be surprised to find how many food products this includes).
If you care about family farms, personal liberties, or the environment, you should also buy organic -- organic certification means no GE -- wherever practical. Monsanto has used some rough tactics on small farmers that don't toe its company line, and the organic farmers threatened by GE varieties blowing into their fields, or being carried there by birds, tend not to be part of Big Ag. They also support crop diversity and petrochemical-free farming by planting varieties farmers have been using for centuries (and not patented by giant corporations), and by keeping chemical formulations and harmful nitrogen-based fertilizers out of the groundwater and agricultural runoff.
No matter who you are, you should support legitimate scientific review of new biotech crops coming to market; all three regulating agencies have periods of public comment before they OK a new GE crop, and Congress has the authority to change the way GMOs are OK'd by the government.

Finally, if you want to keep your head from spinning, make this the last article you read about genetically engineered foods for awhile.
http://www.huffingtonpost.com/paul-tullis/are-gmos-safe_b_794479.html

TUBERCULOSIS: FDA gives grants to fight tuberculosis

Jeffrey Bigongiari on October 5, 2010
The U.S. Food and Drug Administration on October 4 announced that it has awarded nearly $3 million to fund research that will support the diagnosis, treatment and prevention of tuberculosis.
The funding, which amounts to $2.9 million, will go directly towards six different projects that were selected from 30 applicants, and was directed by the FDA’s Critical Path Initiative.
TB remains a major public health threat and continues to rise in prevalence globally. The FDA said that help is needed to shorten therapy and to treat drug resistant forms of the disease.
"FDA recognized an urgent need for the engagement and leadership of public health institutions to promote this critical, but neglected, area of medical therapeutics," FDA Commissioner Margaret A. Hamburg, M.D., said.
The six projects and their research teams that FDA will grant funding to include Aeras Global TB Vaccine Foundation's discovery of biological and immunological biomarkers for TB vaccines and the Global Alliance for TB Drug Development frozen trials for developing a repository of clinical trial specimens.
Also receiving funding will be Global Alliance of TB Drug Development for qualifying new preclinical models for the development of tuberculosis drug combinations, and the University of Georgia Research Foundation, Inc., for the development of a diagnostic for latent TB.
Colorado State University will receive funding for small molecule biomarkers for tuberculosis treatment, relapse and cure, while a grant for the University of Utah will be used for the development and validation of point-of-care tests for tuberculosis.
http://vaccinenewsdaily.com/news/216702-fda-gives-grants-to-fight-tuberculosis

BIOTERRORISM: FDA’s Pivotal Role Fighting Bioterrorism and Emerging Infectious Diseases

With Congress out of session until September 13, the Executive Branch has the opportunity to gain extra column inches and media bandwidth. Thus, last week’s report on medical countermeasures (MCM), released by HHS Secretary Sebelius, drew a lot of interest and a minimum of Congressional comment.
The Secretary released the findings and recommendations from a top-to-bottom review of the Department’s efforts with regard to the development of MCM. In the view of FDA Matters, the report thrusts FDA back into its rightful place as a key agency deserving more resources and respect for its national security responsibilities.
MCM are products that will decrease morbidity and mortality from a bioterror attack or from naturally occurring emerging infectious diseases. Think anthrax or radioactivity from an improvised nuclear device for the first, think H1N1 influenza for the second.
Scientifically and medically, these are difficult products to discover and develop. Financially, they won’t ever be developed without:
federal assistance to promising research; and
a strategic national stockpile and government contracts that will buy proven MCM’s.
As with the larger promise of moving medical therapies from “bench to bedside,” there is no progress without FDA. The agency encourages companies by helping them to define appropriate safety and efficacy endpoints for their particular MCM and works with them to resolve questions of animal models, lab standards, statistical plans, quality manufacturing, etc.
Then, the agency evaluates the testing results and determines whether to approve the product. This work has an additional wrinkle. With most MCM’s (maybe all) it is unethical to do human efficacy trials (e.g. intentionally expose a human being to anthrax to see if the MCM works). Instead, the agency (and the company) must make the difficult evaluation as to whether efficacy in animals is a sufficient surrogate for efficacy in humans.
The Secretary (and the underlying report) found that FDA’s efforts in this area are insufficiently funded. Perhaps for the first time, there was a more global recognition of FDA’s central role in making us safer from bioterrorism and naturally occurring emerging infectious diseases. The Secretary also recognized that FDA needs resources above its current level to do this job well.
The Administration placed a price tag–$170 million in funds to be available until expended–on the size and scope of the monies needed to upgrade FDA’s efforts in this area. The monies will come from dollars previously appropriated to HHS to combat pandemic flu. HHS and OMB have agreed that the monies can be transferred administratively as long as they retain their original purpose of helping to deal with pandemic flu.
However, the Secretary’s recommendation is for the transferred funds to also be used for non-pandemic medical countermeasures. This requires a budget amendment to be sent to Congress to broaden the permitted uses of these funds. How likely is Congress to approve this? We probably won’t know until after September 13.
http://www.fdamatters.com/?p=1095

TUBERCULOSIS: new form of early test

Thursday, May 27, 2010
By Juan Diasgranados - Doctors hope a new test for tuberculosis will be available soon because it can confirm the presence of the disease in 45 minutes rather than the six weeks required by the current test.
Doctors said they are close to being able to use a new test that will allow them to diagnose cases of drug-resistant tuberculosis in 90 minutes, down from six weeks. Cepheid geneXpert, a new TB test jointly developed by Cepheid and the University of Medicine and Dentistry of New Jersey, allows specimens to be tested with high-tech equipment in health settings and to produce results while patients are still in their doctors' offices.The test, which doctors hope will be approved soon, would lead to earlier diagnosis and earlier treatment for patients. A spokeswoman for the Food and Drug Administration said the test is under review but had no information about when a decision will be made.The current test, sputum microscopy, was developed in 1882 and is outdated. It takes six weeks to obtain results, and in that time, doctors lose track of some patients and others die.The Center for Global Health Policy held a briefing last week to discuss its new publication, "Confronting the Global HIV and Tuberculosis Epidemics." The center is a project of the Infectious Diseases Society of America and the HIV Medicine Association through a grant from the Bill and Melinda Gates Foundation.The new publication highlights projects doctors and researchers have been working on that will soon allow them to test tuberculosis patients and shrink the time it takes to diagnose drug-resistant tuberculosis from six weeks to 90 minutes. New tuberculosis drugs will offer a safer and faster cure for standard and drug-resistant tuberculosis.According to the center's website, HIV and tuberculosis are the world's top two most deadly infectious diseases. In 2008, 2 million people died from HIV/AIDS. Tuberculosis claimed the lives of 1.8 million people.Doctors and professionals at the briefing spoke about the deadly epidemics and new discoveries in science that can dramatically change the routes of these diseases."A lot has been accomplished," said Dr. Anthony Fauci, director of National Institute of Allergy and Infectious Diseases. "But tuberculosis is still a threat, and there's still a lot that needs to be done."Fauci said there is only one vaccine for tuberculosis."The current vaccine right now is not very good ... but I'm staying optimistic that one day soon down the line we will have a more effective vaccine for TB," he said.According to the Center for Global Health Policy, the Bacille Calmette Guerin vaccine is the only vaccine for tuberculosis. The vaccine is effective at preventing the disease in children but not for adults.At the briefing, doctors said patients who are infected with both HIV and tuberculosis usually have a high risk of death. The two diseases work synergistically, speeding up the progression of illness. In 2007, one in four deaths from tuberculosis was HIV related.Speakers echoed the need for new policies and the need to push U.S. officials to make "key decisions" in the next few weeks when the debate over global health spending arises. The center is hoping for more funding to provide more research and diagnostic testing along with opportunities to open treatment centers overseas.Dr. Kenneth Mayer, director of the Brown University AIDS program, emphasized the importance of making people around the world award of these issues."We need to push our government and really think strategically how we use our resources to help this crisis," Mayer said.Mayer ended the briefing by saying, "progress has been made, but more can be done. Tuberculosis is still growing."
http://www.infozine.com/news/stories/op/storiesView/sid/41351/