June 28, 2007

Emergent (Bioport), DoD Amend Contract


ROCKVILLE, Md. — Biopharmaceutical company Emergent BioSolutions Inc. on Wednesday said it will accelerate delivery of its BioThrax anthrax vaccine to the Department of Defense.

The company said it expects $20 million in revenue in the second quarter due to the amended agreement with the Defense Department to accelerates delivery of its Biothrax vaccine.

Emergent will deliver 900,000 doses of the vaccine during the quarter ending June 30 or shortly after that.

Emergent said it is also preparing a response to a proposal request from the Department of Defense for a follow-on contract to supply up to 14 million doses of BioThrax to the military. The one-year contract has three option years.

Shares rose 41 cents, or 4.4 percent, to $9.80 during afternoon trading. The stock has traded between $8.33 and $17.75 during the past 52 weeks.

June 25, 2007

Health Care Protection for Military Signed Into Law


Neither the family nor the legislators could have predicted that a new law to protect the military would be signed three days after the first anniversary date of the death of Maine National Guardsman Capt. Patrick Damon, 41, of Falmouth.

The son of Barbara Damon Day of Newcastle and Ellsworth Damon of Whitefield, Damon died on June 15, 2006, after collapsing in his barracks while serving in Afghanistan.

On Monday there was a Memorial Resolution in the House for Damon, who was well known and respected in Augusta as a former aide to speakers of the House. Then Gov. John Baldacci signed into law his emergency bill LD1889, An Act to Protect the Lives and Health of Members of the Maine National Guard, crediting Damon’s family for the incentive to do so.

Day was the driving force behind the legislation, knowing her son did not die of an apparent heart attack as first recorded, and believing he died because his health was compromised by vaccines and medications given as part of military health care and prevention protocols.

“It’s exactly what I asked for,” Day said Monday. The law links the Maine Center for Disease Control and the Maine National Guard in order to create higher and safer standards for preventative medical practices and health screenings. Day said the action will go a long way in preventing the tragedy of future non-combatant deaths and injuries.

“I take this very seriously as Commander in Chief,” said Baldacci, who saw for himself the state of the U.S. health care system for the military after visiting Walter Reed Medical Center. “We need to make sure Maine soldiers get adequate medical and mental health care with higher and safe standards.”

In a written statement, Day said, “Today is another milestone in the healing of the most painful event that can befall a family, the loss of a loved one.”

The law establishes a commission to oversee progress made by the two agencies as they work together. Day said the law also provides a place for families and service members to come to share their stories and concerns “so that the cracks their loved ones fell through may also be closed.”

Day and Baldacci believe this Maine law is groundbreaking because it sets an example for legislation nationwide.

“This law not only casts the State of Maine in the proud role of leader, but shows the desire of human kind to do the right thing,” said Day. “It is one thing to say ‘I’ll never forget your service.’ It is quite another to back that statement up with action.”

June 22, 2007

U.S. Corporations Keeping Biowarfare Work Secret

by Sherwood Ross

A number of major pharmaceutical corporations and biotech firms are concealing the nature of the biological warfare research work they are doing for the U.S. government.

Since their funding comes from the National Institutes of Health, the recipients are obligated under NIH guidelines to make their activities public. Not disclosing their ops raises the suspicion they may be engaged in forbidden kinds of germ warfare research. According to the Sunshine Project, a nonprofit arms control watchdog operating out of Austin, Texas, among corporations holding back information about their activities are:

Abbott Laboratories, BASF Plant Science, Bristol-Myers Squibb, DuPont Central Research and Development, Eli Lilly Corp., Embrex, GlaxoSmithKline, Hoffman-LaRoche, Merck & Co., Monsanto, Pfizer Inc., Schering-Plough Research Institute, and Syngenta Corp. of Switzerland.

In case you didn’t know it, the White House since 9/11 has called for spending $44-billion on biological warfare research, a sum unprecedented in world history, and an obliging Congress has authorized it. Thus, some of the deadliest pathogens known to humankind are being rekindled in hundreds of labs in pharmaceutical houses, university biology departments, and on military bases. An international convention the U.S. signed forbids it to stockpile, manufacture or use biological weapons. But if the U.S. won’t say what’s going down in those laboratories other countries are going to assume the worst and a biowarfare arms race will be on, if it isn’t already.

Sunshine says failure to disclose operations also puts corporate employees involved in this work at risk. Only 8,500, or 16%, of the 52,000 workers employed at the top 20 U.S. biotech firms work at an NIH guidelines-compliant company, Sunshine says.

Francis Boyle, an international law authority at the University of Illinois, Champaign, says pursuant to national strategy directives adopted by Bush in 2002, the Pentagon “is now gearing up to fight and ‘win’ biological warfare without prior public knowledge and review.” Boyle said the Pentagon’s Chemical and Biological Defense Program was revised in 2003 to endorse “first-use” strike in war. Boyle said the program includes Red Teaming, which he described as “plotting, planning, and scheming how to use biowarfare.”

Besides the big pharmaceutical houses, the biowarfare buildup is getting an enthusiastic response from academia, which sees new funds flowing from Washington’s horn of plenty. “American universities have a long history of willingly permitting their research agenda, researchers, institutes and laboratories to be co-opted, corrupted, and perverted by the Pentagon and the CIA,” Boyle says. What’s more, the Bush administration is pouring billions in biowarfare research while some very real killers, such as influenza, are not being cured.In 2006, the NIH got $120 million to combat influenza, which kills about 36,000 Americans annually but it got $1.76 billion for biodefense, much of it spent to research anthrax. How many people has anthrax killed lately? Well, let’s see, there were those five people killed in the mysterious attacks on Congress of October, 2001 --- attacks that suspiciously emanated from a government laboratory at Fort Detrick, Md.

One would think the FBI might apprehend the perpetrator whose attack shut down the Congress of the United States but nearly six years have gone by and it hasn’t caught anybody. Seem a bit odd to you? Some folks suspect the anthrax attack was an inside job to panic the country into a huge biowarfare buildup to “protect” America from “terrorists.” That is, of course, just what happened.

Milton Leitenberg, of the University of Maryland’s School of Public Policy, though, says the risk of terrorists and nonstate actors using biological agents against the U.S. “has been systematically and deliberately exaggerated” by administration scare-mongering.

And molecular biologist Jonathan King of Massachusetts Institute of Technology says, “the Bush administration launched a major program which threatens to put the health of our people at far greater risk than the hazard to which they claimed to have been responding.” King added President Bush’s policies “do not increase the security of the American people” but “bring new risk to our population of the most appalling kind.”In the absence of any credible foreign threat, Sunshine’s Hammond said, “Our biowarfare research is defending ourselves from ourselves. It’s a dog chasing its tail.” Sadly, it looks more and more every day like a mad dog.

(For more on this subject, see the author’s article in the July/August issue of The Humanist magazine. Sherwood Ross has worked as a reporter for major dailies and wire services. Reach him at sherwoodr1@yahoo.com)
Sherwood Ross has worked in the civil rights movement and as a reporter for major dailies and wire services.

Biological Weapons Research and Development Pose Risks Worldwide

from the Sunshine Project: (Note that such work may transgress the biological Weapons Convention, an international treaty initiated by the Nixon admnistration, to which the US is a party.

Army to Triple Germ War Tests in UT

Biological Weapons Research and Development Pose Risks Worldwide
by Steve Erickson

At a remote, secretive desert base 75 miles west of Salt Lake City, the Army plans to renovate an historic cold war laboratory to expand dramatically its biological warfare testing.

The US Army proposes to completely rehab the drab Baker Laboratory, a centerpiece of the Dugway Proving Ground (DPG) since 1952. The lab is listed on the National Historic Register not for its architecture but for its role in testing germ war agents both in sealed chambers and in the field. DPG itself has been the nation's premier biological and chemical warfare testing facility since the end of World War II.

Gearing up Dugway's bio-warfare testing activities is part and parcel of the Bush Administration' s massive post 9-11 build up of the military and bio-defense business, including the proliferation of new BSL-4 and BSL-3 labs across the country. Billions of dollars have been spent in the past five years in bio-defense research, much of it at the nation's premier research universities. This build up of bio- defense capacity has gone largely unnoticed by the public and mainstream press, except on the east and west coasts, where proposed new labs in Boston and at the Lawrence Livermore nuclear weapons lab have generated controversy and strong opposition.

The renovated Baker lab will contain "as many as eleven Bio Safety Level-3 laboratories and fourteen Biological Safety Level-2 laboratories, " according to the recently released Environmental Assessment. This will approximately triple Dugway's current BSL-3 lab capacity and double its BSL-2 capabilities to meet increased demand from the Defense Department and its contractors for testing detection and protective equipment against some of the world's deadliest pathogens.

Safety levels of labs are defined by their engineered precautions. A BSL-2 lab can handle viruses and bacteria common in the environment. BSL-3 labs are equipped and permitted to work with the deadly and traditional bio-weapons pathogens for which there are either vaccines or cures, such as anthrax. BSL-4 labs are the Cadillac-they can test the most deadly pathogens for which there is no prevention, no cure. Think Ebola, Marburg.

The crown jewel of the refurbished lab at Dugway would be the Whole System Live Agent Test chamber (WSLAT). It would be capable of testing large equipment like nuclear, biological and chemical agent detection vehicles against relatively huge quantities of aerosolized live agent, presenting possibly increased risks to lab personnel and the environment beyond those previously assessed by DPG for small chamber live agent testing.

Concerns about this facility are heightened by its large capacity, industrial strength chamber, coupled with the recent solicitations by DPG for two 1,500-liter fermenters and for 1,500 liters of Anthrax sterne var. Since the Army denied Freedom of Information Act (FOIA) requests by the Citizens Education Project, a local grassroots organization leading the opposition to Dugway's expansion, it is not known whether new fermenters and large quantities of this non- pathenogenic form of anthrax were ever delivered to Dugway. Dugway did admit in 2002 that it has been secretly producing quantities of germ agents like the deadlier strains of anthrax after two decades of denying live agent production.

History and Context of Bioweapons

As Edward Hammond of the Sunshine Project points out, biological weapons are nearly as old as war. In Roman times, wells were poisoned. Two hundred years ago in North America, the British Army attacked Native Americans by using smallpox-infected blankets. In World War II, the Japanese Army used bioweapons on a large scale in China. This list continues, and current technological advances increase the risk drastically.

Former Senate Majority Leader Bill Frist said in 2005 that bioterrorism is "the greatest existential threat we have in the world today" and called for a biodefense research and development effort that "even dwarfs the Manhattan Project." Others see the risk posed by governments and militaries engaged in biological weapons "defense" as at least as dangerous. The boundary between offensive biological warfare or terrorist programs and biological defense can be quite murky.

To address the threat of offensive bioweapons, in 1972 countries agreed to the the Biological and Toxin Weapons Convention (BTWC), which bans the development or production of biological agents for non- peaceful purposes. Recently, US military officials have called for a renegotiation of the BTWC to enable the development of gas-guzzling bacteria to curtail an enemy's mobility (by eating up their gasoline or attacking drug-producing plants).

Moreover, verification of the BTWC is especially difficult because bioweapons research is beset with the problem of dual-use technology. Nearly all the know-how and equipment necessary for an offensive biological warfare program has applicability to civilian medical or biological research. A very thin line separates offense and defense bioweapons research. Also biodefense research can be problematic as in many cases defensive work generates an offensive capability.

History of Dugway

The Dugway Proving Ground has played a central part in the research and development of bioweapons, in part because of its geographic location. Framed by the 11,000-foot Stansbury Mountains on the east, the 12,000-foot Deep Creeks on the west and the alkali salt flats of the Great Salt Lake desert to the north, Dugway is a restricted military reservation covering some 800,000 acres, roughly the size of Rhode Island, in the Utah portion of the Great Basin. It's a harsh environment with very little rainfall, sparsely populated. Though starkly beautiful with vast vistas and clear skies, some might consider the area desolate and useless. For these reasons, the area has long attracted a wide variety of hazardous industries and military activities, including the testing of weapons of mass destruction.

Dugway is surrounded by two chemical weapons incinerators one mountain range to the east, a radioactive waste dump, an Air Force bombing range, a hazardous waste landfill, and a hazardous waste incinerator to the north. The airspace above is home to supersonic and electronic warfare training.

Established in 1942 to host World War II training and weapons development, Dugway's history is not a pretty one. A German village at Dugway was used to determine how best to use incendiary bombs to fire bomb Dresden and other German cities. Japan village was used to perfect flame throwers to combat Japanese soldiers hunkered in Pacific island caves.

After the War, the mission gradually evolved into the testing of chemical, biological and radiological weapons, as Dugway emerged as the center for open air testing for the Army's Test and Evaluation Command (TECOM). Throughout the 1950s and 60s, Dugway conducted over 1,000 open air chemical weapons tests with GB, VX and mustard agents, over 200 open air biological weapons tests involving a potpourri of pathogens. Not to be ignored, nearly two dozen open air radiological tests, most involving radioactive tantalum but also using radioactive Cobalt 60 on at least one occasion, were also conducted.

Many of these tests involved human participants - civilian workers and military personnel - and some used military volunteers in what can only be described as human experimentation. Seventh Day Adventists volunteered for Operation Whitecoat. In one Whitecoat test performed at Dugway, Adventist volunteers sat on a hillside with their shirts off waiting to be bit by infected mosquitos released by Dugway to determine the effectiveness of using insects as vectors to deliver biological weapons.

The cavalier, cowboy-style of WMD testing came under intense scrutiny when, in 1968, over 6,000 sheep in the Skull Valley bordering Dugway died grisly deaths from VX nerve gas released from Dugway. Although initially denying any involvement, the Army finally acknowledged their guilt at the end of the Clinton Administration.

The sheep incident, followed three years later by the ratification of the Biological Weapons Convention, signaled an end to much of the outdoor testing of actual agent. Tests with actual agent were moved inside secure laboratories. In the late 1980s, Dugway proposed construction of a Bio-Safety Level 4 lab-the Biological Aerosol Test Facility-to replace the aging Baker Lab. Concerns about Dugway playing with the deadliest of pathogens and possibly genetically engineering them in the secrecy of the desert created a huge outcry, and the Army was forced to abandon the plan after an eight-month campaign by the opposition. To our knowledge, this was the first or only time that a grass roots citizen movement stopped a biological weapons development. Nonetheless, Dugway succeeded three years later, under the cover of the first Gulf War with Iraq, to re-open the Baker Lab, and later won approval for a BSL 3-plus lab, the Lothar Solomon Life Sciences Test Facility adjacent to the Baker facility, which is now the key bio-defense research facility at Dugway.

Current Dugway Development ProposalsThe proposed make-over of the Baker Lab is part of plans approved three years ago to more than double Dugway's biological defense activities, double its chemical defense program, and create a new counter-terrorism training mission. This massive expansion of Dugway's role involves at least seven new facilities and renovations of three others. It's a troubling, dangerous and destabilizing development which will take place with the extraordinary secrecy that is the hallmark of Dugway's modus operandi. Given their track record, this expansion is not to be trusted.

The trust level isn't improving. FOIA requests for a list of all the pathogens that Dugway maintains in its inventory-stored in what we refer to as Pandora's Icebox-have gone unanswered for years. The Army refuses to provide us, the press, and the public any information whatsoever regarding the Dugway's assistance in the botched FBI investigation into the anthrax letter attacks of the fall of 2001. Dugway itself was under suspicion as the source for the highly milled Ames strain of anthrax, but cooperated with the FBI by "reverse engineering" the strain of anthrax that they may have been the source of in the first place. More recently, Dugway has been in the forefront of experiments releasing Sodium hexafluoride gas (SF 6) in major metropolitan areas like New York City and Salt Lake City to assess flow patterns that might occur in a major biological weapons attack against a US city.

Opposition to DPG Expansion Mounts

Dugway's expansion has been well under the radar. That's deliberate, says Bev White, a former Utah State Representative and organizer for the Dugway League, seeking justice for the victims and survivors of Dugway's past testing. "They do what they want out there, then claim they never did it, and now they just wait until all the witnesses are dead," she said. "They're all sick and dying. Just like the Atomic Vets and Nevada Test Site workers - no justice, no compensation for their service and sacrifice. Their stories must not be forgotten."

Groups like the Citizens Education Project (CEP) in Salt Lake City have worked to shine a light on the proposed expansion. CEP has repeatedly used the Freedom of Information Act to acquire information about the Army's plans, publicizes the information it does receive, and works with coalitions nationally and internationally.

Greater transparency and oversight of biological agent research at Dugway and throughout the country, and a renewed US commitment to strengthening the Biological Weapons Convention are critical to preventing potentially disastrous releases of pathogens and to stemming proliferation of bio-weapons.

Steve Erickson is the director of the Citizens Education Project. For more information, contact CEP, 444 Northmont Way, Salt Lake City, UT 84103

CDC's anthrax vaccine trial exclusions tell us CDC knows more about anthrax vaccine reactions than it's telling

CDC began a 1564 person clinical trial of AVA/Biothrax in 2002. The purpose was to identify adverse reactions and get a license change to allow intramuscular injections and fewer doses:

Somehow, surveillance for adverse reactions turned into a search for primarily local, acute reactions. Nonetheless, there have been over 100 serious adverse events in study subjects, though CDC claims they are unrelated to vaccination.

CDC identified a number of medical illnesses that would lead patients to be excluded as participants. By a strange coincidence, these illnesses are also those that have been reported frequently after anthrax vaccine, as potential adverse reactions. The fact that CDC used them as exclusionary criteria suggests CDC was well aware of what deleterious things anthrax vaccine can do. Perhaps CDC's claim that the serious reactions are unrelated to anthrax vaccine is disingenuous?

Here are some of the exclusions:
1. Moderate to severe asthma
2. Active coronary artery disease
3. Pregnancy or failing to use birth control during the study
4. Active cancer, leukemia or lymphoma
5. Cardiomyopathy or congestive heart failure
6. COPD or other significant pulmonary disease
7. Liver or kidney disease
8. Autoimmune disease
9. Neuropathy or other evolving neurologic condition
10. Mental illness
11. Seizures

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
207-288-5081 ext. 220

June 19, 2007

Trial to Test New Smallpox Vaccine


DURHAM, N.C. – Researchers at Duke University Medical Center and six other medical centers in the United States will be running tests to compare an established smallpox vaccine against a newer one that may offer fewer side effects. The question is which will provide the best and quickest protection against a possible terrorist attack using the smallpox virus.

Although the World Health Assembly declared that smallpox was officially eradicated as a disease in 1980, stockpiles of the virus may exist and worries remain that they may fall into the hands of terrorists.

Smallpox is a highly contagious disease that causes fever, malaise and severe rash and kills about 30 percent of people infected. There is no effective treatment, said Chip Walter, M.D., who is directing Duke’s effort in the trial, which is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

"It is important that we be as prepared as possible for a bioterrorist attack," Walter said. "There are still concerns that there could be groups who have access to the virus with the intent to harm others. Although the probability of release of smallpox through a terrorist attack is low, the effect could be devastating, since much of the population has not been protected through vaccination."

If a terrorist were to unleash the virus, the goal would be to vaccinate people in the areas closest to the attack, as well as first responders such as ambulance crews and emergency room staff. For this reason, the time it takes a vaccine to provide immunity is crucial, Walter said.

The trial, which begins this month, will compare various doses, combinations and dosing schedules of the two vaccines to determine which can stimulate an effective immune response to the virus in the least amount of the time.

The established vaccine, called Dryvax®, has been used for decades, but it has rare and serious complications in some individuals, such as severe skin rashes and inflammation of the heart and brain. It is the vaccine given to U.S. soldiers in the Middle East.

The newer vaccine, called Imvamune®, appears to lead to a good immune response with fewer side effects. But being new, little is known about the dosing schedule that will lead to the most rapid immune response.

In the trial, researchers will periodically test blood samples from participants to determine what types of immune responses the vaccines and their combinations are stimulating and to monitor for side effects. Duke plans to enroll 30 healthy volunteers who were born after 1971 and who have not been previously vaccinated against smallpox.

"The results of the trial will help us determine the best and safest approach to achieving protection in the event of a bioterrorism attack using smallpox," Walter said.

Other centers in the trial include University of Iowa, University of Maryland, Saint Louis University, University of Rochester, University Hospitals of Cleveland and University of Texas Medical Branch at Galveston.

Drug, Food Risks Stay Secret as Inquiries to U.S. FDA Pile Up


Drug, Food Risks Stay Secret as Inquiries to U.S. FDA Pile Up
By Justin Blum

June 19 (Bloomberg) -- Claudia Krcmarik can't get documents about her father-in-law's death during a medical study. Meryl Nass keeps asking for records she thinks will show an anthrax vaccine is dangerous. The American Bakers Association's request for a paper on the safety of imported honey has languished.

All filed public information requests with the U.S. Food and Drug Administration at least four years ago and have yet to receive what they asked for -- even though American law says agencies must release records ``promptly.''

The FDA's 20,365 unfilled requests for information exceed the totals for the departments of Defense and Justice. One company, FOI Services Inc., accounts for 44 percent of the backlog, according to the agency. Researchers, consumer groups and individuals say the delays limit their ability to alert the public to food and drug dangers and to hold the FDA accountable.

``It is important information that we need to tell this story,'' said Krcmarik, of Ann Arbor, Michigan, who wants to know how her father-in-law was given an overdose in an FDA- regulated clinical trial before he died in 2002. ``That information should be available, and it should be timely. What we wanted to avoid is this happening to anyone else.''

The FDA's oversight of food and drug safety has come under criticism by advocacy groups and lawmakers. They say the agency failed to act effectively before Vioxx, a Merck & Co. painkiller, was withdrawn in 2004 because of a link to heart attacks and strokes and didn't alert the public more recently to heart risks associated with GlaxoSmithKline Plc's diabetes drug Avandia. They also fault the FDA for failing to prevent contamination of peanut butter, spinach and pet food.

Freedom of Information Act

U.S. agencies are required to provide access to documents under the Freedom of Information Act, a law passed in 1966 to increase accountability. When President Lyndon B. Johnson signed the measure, he said in a statement: ``A democracy works best when the people have all the information that the security of the Nation permits.''

Requests to the FDA, which regulates food, drugs and medical devices, can involve life-and-death matters, including reports of deadly effects from medications and studies used to justify the safety or effectiveness of products cleared for sale.

Backlogs of requests at U.S. agencies have grown in recent years, and lawmakers have criticized the government for failing to provide documents promptly. The number of requests at the FDA exceeds the backlog of 18,216 at the Defense Department and 8,004 at the Justice Department at the end of fiscal 2006, the most recent data available.

Backlog Increases

The FDA's total of 20,365 on a day last month when the agency provided data was up from 19,948 at the end of the 2006 fiscal year and 13,626 at the end of fiscal 2000, according to the FDA's Web site. The most recent figure included 1,924 that are more than three years old.

To determine the effect of the FDA's backlog, Bloomberg News filed a Freedom of Information Act request with the agency last November for copies of the longest-pending inquiries. The FDA responded in April.

The requests for documents came from drugmakers, such as Pfizer Inc. and Merck & Co., consumer advocacy groups, individuals and, most of all, from FOI Services.

The closely held company built a business out of obtaining agency documents and reselling them. In the process, it ``inundates the agency with workload,'' said Fred Sadler, head of the FDA office that handles the public inquiries.

FOI Services, of Gaithersburg, Maryland, says on its Web site that it has collected more than 150,000 FDA documents, amassing what it bills as the ``World's Largest Private Library of FDA-Related Documents & Reports.''

`Aggregating Requests'

The company seeks material for customers, mostly drug and medical-device companies that don't want their identities revealed because they may be seeking information about a competitor's product, said Marlene Bobka, vice president of FOI.

FOI Services, founded by lawyers whose clients sought information from the FDA, also requests documents to post on its Web site on speculation that the information will attract buyers.

``What we're doing really is aggregating requests from industry,'' Bobka said. Without her company, the FDA ``would still get these requests. They would just come from different firms,'' she said.

It's impossible to assess independently whether FOI Services has made the FDA's backlog worse than it would be otherwise, and Sadler said he isn't sure.

$50.95 for a $5.40 Document

The company won't reveal its profit on documents. A two- page report on an FDA inspection from 2002 sells for $50.95 on the FOI Services Web site. The FDA billed the company $5.40 to process and provide the document, according to Sadler.

As the FDA's backlog has increased, the agency has cut back the number of workers handling requests. The equivalent of 88 full-time staffers worked on filings last year, down from 123 in fiscal year 1995, according to Sadler. During that time, the number of new requests has decreased as the FDA has posted more free information on its Web site.
The backlog ``suggests that maybe we need to put some more resources into'' handling the requests for documents, Sadler said in an interview. An FDA spokeswoman, Julie Zawisza, said in an e-mail that the agency has limited money and must ``divvy it out as conscientiously as we can.''

Pfizer, Merck, Public Citizen

Among requests that FDA records showed as pending for more than four years, New York-based Pfizer sought all inspection reports for a plant in Puerto Rico. Merck, of Whitehouse Station, New Jersey, requested documents on thimerosal, a preservative containing mercury that is used in vaccines.

Public Citizen, a Washington-based public-interest organization, sought information on the dangers of various drugs.

The Freedom of Information Act generally requires federal agencies to determine within 20 days whether to provide requested information or to decline on the basis of exceptions such as national security or to avoid revealing trade secrets. No deadline is set for producing documents, although the law says agencies must make the records ``promptly available.''

The FDA's backlog includes requests that were filed as long ago as 2000. The agency says it generally processes requests in the order received. Some divisions in the agency have bigger backlogs than others, resulting in longer waits. Some cases also take longer because they're more complicated and may require extensive searching and removal of confidential information, Sadler said.

The average number of unfulfilled requests has increased across 26 federal agencies tracked by the Coalition of Journalists for Open Government, a group in Arlington, Virginia, that advocates access to government records. Reporters from news organizations, including Bloomberg News, are among those whose requests the FDA hasn't fulfilled.

Year-End Backlog

The coalition compared the year-end backlog of requests with the number processed during the year. For fiscal 2005, the most recent data available, the backlog at 26 agencies equaled 31 percent of the requests. Applying the same calculation to the FDA, which wasn't included in the tally, the ratio was 94 percent, according to data on the FDA's Web site.
Krcmarik, the Michigan woman seeking information on her father-in-law's death, has been waiting since February 2003 for documents. Cyril Krcmarik, the father-in-law, died in 2002 at a veterans hospital in Detroit while being treated for prostate cancer as part of a research study. Over less than a month, he was given a nine-month supply of a steroid for side effects of chemotherapy.

Family Lawsuit

Claudia Krcmarik, who works for a drugmaker, sought the documents from the FDA for a lawsuit against the U.S. Veterans Affairs Department that the family later settled. She still wants the paperwork made public.

``If there's any information that could help other people know as consumers what they're getting into, then that information should be available,'' she said.

Nass, a doctor in Bar Harbor, Maine, said she has treated patients who suffered harmful side effects from the anthrax vaccine. She requested documents from the FDA that she said will show the product's dangers and that the agency never should have cleared it for use.
She first asked for records in 2001 and sent a follow-up request in 2003. Most of the documents she needs haven't been turned over, Nass said.

`Protecting the Agency'

``Clearly, protecting the agency and previous agency decisions is much more important to the FDA than providing the public information that would allow it to make an independent decision about the safety and efficacy of licensed drugs,'' said Nass, who served as a consultant on litigation brought by members of the military against the Defense Department for requiring anthrax vaccinations.

The FDA doesn't withhold information to protect its decisions from criticism, agency spokeswoman Zawisza said.

The maker of the vaccine, Emergent BioSolutions Inc. of Rockville, Maryland, stands by the product's safety. ``Not a single death has been documented to have resulted from receipt of anthrax vaccine,'' company spokesman Robert Burrows wrote in an e-mail.

Lee Sanders, a senior vice president with the American Bakers Association, requested FDA documents on imported honey in 2002. The Washington-based association wanted to know about a pesticide in honey imported from China, she said in an interview.

``You would hope that those types of requests would be handled in a more expeditious way,'' she said.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .

June 15, 2007

Former Federal Official Joins Emergent Board

Former federal official joins Emergent board
by Neil Adler, Staff Reporter

The directors of Emergent BioSolutions Inc. appointed Sue Bailey, a physician with experience in health affairs at the Defense Department, to the company's board.

She was elected for a two-year term that will expire at Emergent's 2009 annual stockholders meeting, the Rockville-based biopharmaceutical company said in a statement Friday.

Bailey, whose career has included a faculty position at Georgetown University Medical School, was assistant secretary of defense for health affairs from 1998 to 2000, where she headed the department's $17 billion military medical system. She had served as deputy assistant secretary of defense for clinical services from 1994 to 1995.

After leaving the Defense Department, Bailey was administrator of the National Highway Traffic Safety Administration and then a news analyst for NBC from 2001 to 2006, focusing on national security, bioterrorism, environmental safety and public health.

Emergent (NYSE: EBS) has a vaccine for anthrax infection on the market. Its pipeline includes other drugs and vaccines to fight bioterror agents and infectious diseases.

Bailey received her medical degree from the Philadelphia College of Osteopathic Medicine.

June 11, 2007

Congress Tried to Solve the Problems with Anthrax Vaccine, But Failed

Congress Tried to Solve the Problems with Anthrax Vaccine, But Failed

Congress tried to fix the worst aspects of the anthrax vaccine program, and obtain more reliable information on anthrax vaccine between 1999 and 2002.

Congress appears to have failed for two reasons: it does not like to step on DOD's toes, and it was outsmarted.

Congress demanded Vaccine Healthcare Centers

Congress likes win-win situations and has tried to solve the anthrax vaccine problem by creating win-win solutions. When it faced the wrath of the upper levels of the Department of Defense, on the one hand, and injured and scared troops, on the other, instead of ending the vaccine program, Congress mandated the creation of Vaccine Healthcare Centers, where those who believed they had received a vaccine injury would be treated, and their illnesses could be researched.

However, six years later, soldiers do receive treatment at the four Vaccine Healthcare Centers --but overall, no one has been cured, and only a few have been significantly improved. The Centers themselves have had to fight for funding each year, and face threats of closure. They have done research, according to a 2007 talk by the Clinics' founder/director, Renata Engler M.D., recently retired head of Allergy-Immunology at Walter Reed Army Medical Center. But none of it has been published in medical journals or made available to the public. Only one 2002 abstract, describing the first 82 patients treated, can be found. Yet over 2,000 more patients have had complete evaluations at the Vaccine Healthcare Centers since.

Dr. Engler has given a number of talks about anthrax vaccine issues, many of which are available on the internet. On the one hand, while on active duty, Dr. Engler claimed that vaccine safety concerns have been based on rare cases -- but on the other hand, she also said in April 2007 that serious adverse events in 1-2% of vaccine recipients may need exemption management, and admitted that the adverse effects from mixtures of drugs and vaccines are unknown. One million six hundred thousand soldiers have received anthrax vaccinations since 1998. If 2% had a serious adverse reaction, that would be 32,000 already-injured people.

Thus the Vaccine Healthcare Centers, at Walter Reed, Fort Bragg NC, Norfolk VA and Wilford Hall TX, have neither clarified questions regarding adverse reactions from anthrax or other vaccines used in the military, nor have they developed curative treatment protocols. Most military medical providers are not aware the Centers exist, and injured soldiers frequently fail to be referred to them for assistance.

Congress demanded Medical Research on Anthrax Vaccine

Congress also required that the Centers for Disease Control and Prevention (CDC) research adverse reactions to anthrax vaccine. To ensure that adequate and effective research projects were undertaken, Congress demanded in 2000 that an Institute of Medicine Committee be formed to guide CDC in this endeavor.

The Institute of Medicine Committee did a good job of evaluating CDC's proposed research projects and recommending which were most valuable. This Committee also emphasized the need to perform longitudinal research to assess the possibility of reactions developing months or years after vaccination. Its report was published in 2003.

However, CDC (which has been paid many millions of dollars by DOD to do this research) has failed to follow the Institute of Medicine recommendations regarding use of military medical databases to assess long-term adverse events. Its one published study, of optic neuritis following vaccinations, used an arbitrary cutoff of 18 weeks following vaccination for a diagnosis of optic neuritis to be made. (Incidentally, this required that soldiers had to receive the diagnosis while in a war zone, given the fact they are vaccinated immediately before deploying to Iraq or Afghanistan for six to twelve months. This virtually guaranteed that only the most severe cases would meet the inclusion criteria established by CDC.) It was therefore no wonder that, although military optic neuritis hospitalizations are much commoner after anthrax vaccination, CDC failed to find more cases in the vaccinated. Other studies are pending, but are being carried out by the same group that 'cooked' this first study. I expect they will reach whatever conclusion the funder desires.

Congress supported research on 2nd and 3d generation "replacement" anthrax vaccines

However, the 2nd generation VaxGen anthrax vaccine, made by using a higher concentration of the same active ingredient as the current anthrax vaccine, Biothrax, failed during advanced development, and will not be able to supercede Biothrax. HHS cancelled the contract in December 2006.

The National Institutes of Health rescinded their proposal to fund research on a 3d generation anthrax vaccine in March, when they were dissatisfied with all the proposals submitted. Currently no anthrax vaccines appear to be in development, and no replacement for Biothrax is in the works.

Emergent Biosolutions, a.k.a. Bioport, spent millions to acquire a lobbying "dream team" -- then sold 10 million more vaccine doses to the government for civilian use!

Bioport has had on its payroll a former US Surgeon General, an Army Surgeon General, a former head of the Joint Chiefs of Staff, and many others who had responsibility for biodefense procurement in their former roles in government. One of the PR firms employed by Emergent Biosolutions is DC Navigators, which boasts of its ability to do its own grassroots organizing. DC Navigators has had as clients 8 state Governors and 8 US Senators, among others. Emergent spent over 2 million dollars in 2006 alone on nine lobbying firms.

Perhaps as a result, NIH is now considering purchase of 22.75 million more doses for the civilian stockpile. The current cost is $24.78 per dose, or $563 million for this addition to the National Strategic Stockpile. The original 10 million doses of anthrax vaccine in the civilian stockpile cost approximately $220 million. Military vaccine has cost at least an additional $100 million. All told, Emergent Biosolutions has done extraordinarily well since purchasing the vaccine manufacturer for $25 million in 1998, when the vaccine cost about $3.00 per dose.

Fear-mongers scared Americans with images of anthrax weapons and mushroom clouds.

Now we know it was all hype--but we didn't know it then. Failing to prepare for an anthrax attack by Saddam Hussein's troops would have made Congress appear careless. Just in case Congress didn't get it, real anthrax spores were sent to the Capitol, leading to enormous fear throughout the United States, a prolonged and expensive clean-up, and billions of dollars appropriated for responses to bioterrorism, including plenty of anthrax vaccine.

Congress did its job -- but nothing changed

Congress held 13 hearings that dealt with anthrax vaccine between 1999 and 2001. Congress commissioned studies on anthrax vaccine from the GAO, the Congressional Research Service, and the Institute of Medicine. Congress made sure specialized medical care for vaccine-injured soldiers was made available within the military.

Congress learned the vaccine was only questionably effective. Congress learned some people were being severely injured by the vaccine. What was unclear then, and remains unclear today, is how many are injured, how badly, by what mechanisms, and whether they ever recover.

By late 2000, vaccinations had ceased due to multiple manufacturing failures at the anthrax vaccine plant. No new vaccine could be shipped out. FDA withheld a license for the manufacturing facility, even after it was completely renovated at taxpayer expense. Then the anthrax letters were sent, and HHS Secretary Tommy Thompson insisted the anthrax plant would be given its license. Thompson also gave DOD an "Emergency Use Authorization" to use anthrax vaccine after its license was lost in 2004.

In 2004, a lawsuit challenging the vaccine's licensing process led to the license being suspended, and mandatory vaccinations ceasing for two years. Subsequently, the FDA issued the comment period that had previously been missed, ignored the many scientific challenges the comment period generated, and reapproved the vaccine license. Resumption of mandatory vaccinations was announced in October 2006, and several hundred thousand soldiers have since been vaccinated.

It's deja vu all over again: No documented threat. A suspect manufacturer. A vaccine unlikely to be effective against weaponized anthrax made by a skilled adversary. And lots more people being harmed.

Unfortunately, the vaccine produced now is no better than the vaccine made in the old facility. The FDA continues to receive adverse event reports at the same rate as before: one in every 250-300 recipients reports problems to the FDA Vaccine Adverse Event Reporting System. And the director of the Vaccine Healthcare Centers, Dr. Renata Engler, who has data on thousands of reactions, said there are "No apparent differences between pre-renovation and post-renovation lots."

Congress used various means at its disposal to ameliorate the worst problems associated with anthrax vaccine, and attempted to assure the vaccine was thoroughly investigated. Yet these measures have been thwarted, the research corrupted and the military medical data withheld. False threats were manufactured to spur biodefense spending, including the purchase of inadequate but already existing "solutions" like anthrax vaccine.

It is now time, after nine years of the on-again, off-again anthrax vaccine program, for Congress to stop mandatory vaccinations unless and until a proven safe, effective vaccine becomes available.

June 6, 2007

Bavarian's Smallpox Vaccine Pact Worth Up To $1.6 Billion

Bavarian's Smallpox Vaccine Pact Worth Up To $1.6 Billion
By Cormac Sheridan
BioWorld International Correspondent

Bavarian Nordic A/S could earn a total of $1.6 billion from its contract with the U.S. Department of Health and Human Services to supply a stockpile of next-generation safe smallpox vaccines.

The base contract, which calls for the delivery of a stockpile of 20 million doses of Bavarian's Imvamune vaccine, is worth $500 million. It was administered under the so-called Request for Proposals 3 (RFP-3) process, which has been under way for five years. It also will support the company's efforts to fulfill requirements for the use of Imvamune in an emergency and to obtain registration for its use in healthy people.

The Bavarian vaccine is based on a modified Vaccinia ankara (MVA) vector and, unlike existing smallpox vaccines, is intended to be administered to people with skin disorders and immune deficiencies. The standard vaccine can result in life-threatening complications in those categories of recipients, and potential recipients therefore have to be screened in order to ensure that they can be vaccinated safely.

The optional elements of the contract include a provision for the delivery of a further 60 million doses, as well as support for clinical studies to extend product approval to children, elderly and immunocompromised people.

"We have spent far more resources negotiating that part," Rolf Sass Sorensen, vice president of communications and investor relations at Bavarian Nordic, told BioWorld International. Some of those studies already are under way.

Moreover, the HHS was anxious that the Kvistgaard, Denmark-based firm communicated the optional elements of the contract when disclosing the award. It is realistic to expect the company will secure some or all of the optional elements of the contract, he said. However, he added: "We have no guarantee - that is important to state."

Nevertheless, there is considerable scope for supply of additional doses of Imvamune. As the vaccine requires two doses, the initial supply only will cover 10 million people. Although U.S. authorities already have secured a large stockpile of standard smallpox vaccine from Cambridge, UK-based Acambis plc - an unsuccessful bidder for the RFP-3 contract - the Imvamune vaccine would be cheaper to administer, Sorenson said, because of the screening requirement attached to the older vaccine.

Bavarian will receive $150 million of the contract in the form of milestone payments, $125 million of which will be paid during 2007 and 2008. It is the first time that a Bioshield program contract has been structured in that fashion, Sorenson said. He attributes it to the establishment last year of the Biomedical Advanced Research and Development Authority (BARDA), which has led to a recognition on the part of the authorities that many of the companies involved in biodefense work are small entities with limited resources.

The failure of Brisbane, Calif.-based VaxGen Inc. to deliver on a $877.5 million anthrax vaccine supply contract has been another significant factor in determining the structure of the deal. "They have really looked into how to make this contract a success," Sorenson said. "VaxGen didn't meet the milestones. With that in mind, we were asked to suggest milestones that could be met."

Because of the earlier than expected flow of cash, Bavarian Nordic altered its financial guidance for 2007. It now expects to post a loss before tax of DKK50 million (US$9.1 million) this year, having previously guided a loss of DKK350 million. It raised its revenue forecast from DKK130 million to DKK380 million.

The company also will be able to devote more attention to the rest of its development pipeline. It is starting new Phase I clinical trials of vaccines for breast cancer, prostate cancer and HIV, and it is commencing new vaccine development programs in respiratory syncitial virus and measles. The latter will enter the clinic shortly.

U.S. Department of Health and Human Services addresses bioterrorism with five-year plan

"There is zero evidence that any known terrorist group has anywhere near the capability to launch a high-casualty biological attack," said UC Davis professor of microbiology Mark Wheelis. "There has been a certain amount of interest in the past, but the actual capability is zero."


U.S. Department of Health and Human Services addresses bioterrorism with five-year plan
Anthrax, smallpox most likely viral weapons, experts say

In its effort to improve response measures to incidents of bioterrorism and natural disease outbreaks, the U.S. Department of Health and Human Services recently announced a five-year plan to develop, improve and stockpile antibiotics and vaccines for a number of deadly viruses and toxins.

Since the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, also known as Bioshield Two, HHS has been charged with developing countermeasures against chemical, biological, radiological and nuclear threats.

The Public Health Emergency Medical Countermeasures Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats identifies key areas of research, acquisition and development programs for public health emergency preparedness. "Since the terrorist attacks of Sept. 11, our mission has been to protect Americans by securing medical countermeasures for a range of threats," HHS Secretary Mike Leavitt said. "We have made significant progress to increase our preparedness in this area, but there is much more we must do."

The Biomedical Advanced Research and Development Agency, which operates under the umbrella of HHS, prioritized response measures to a host of deadly health threats, with anthrax and smallpox at the top. While a successful anthrax or smallpox attack would be devastating, experts generally agree that the chances of such an attack in the near future are slim. "There is zero evidence that any known terrorist group has anywhere near the capability to launch a high-casualty biological attack," said UC Davis professor of microbiology Mark Wheelis. "There has been a certain amount of interest in the past, but the actual capability is zero."

However, Wheelis noted that it is still prudent to stockpile antibiotics and vaccines in case of a natural disease outbreak or the technology to weaponize biological agents becomes possible in the future. Anthrax would be the most likely candidate for such an attack, according to Wheelis.

"The genie is out of the bottle," Wheelis said. "There has been a bioterrorism attack [the anthrax letters of 2001]. The threat will increase in the future, but it is not clear how rapidly it will increase."

While anthrax can be released into the air and could potentially infect tens of thousands of people if released in a densely populated area, it is unlikely that any organization has the capability to mount such an attack, according to experts. Anthrax is not very contagious, which means that tracking down and treating people exposed to such an attack would be feasible. If smallpox were used in an act of bioterrorism, it would likely turn into a global pandemic which could kill millions of people, most in developing countries, where vaccinations are not prevalent and access to medical care is limited. However, smallpox is reportedly only known to exist in two highly secure laboratories, one in the United States and the other in Russia.

According to UC Davis history professor Louis Warren, the use of smallpox as a weapon by any terrorist group would be just as devastating, if not more so, to their own people. "It is probably the deadliest pathogen in the history of the human species," Warren said. "It's probably caused more deaths over the course of human history than any other malady. On the other hand, you have to start thinking why you are being told to be so afraid of it."

Much of the media's and government's portrayal of bioterrorism is driven by fear, Warren added. A better way to approach the issue, he said, is from a public health perspective.

MICHAEL BOTT can be reached at city@californiaaggie.com.

June 5, 2007

What 's the evidence that anthrax vaccine will protect people after a bioterrorist attack?

by Meryl Nass, M.D.

Back to Basics:
What 's the evidence that anthrax vaccine will protect people after a bioterrorist attack?

Actually, there is no evidence from any study that the licensed anthrax vaccine (aka Biothrax) has protected anybody against any form of anthrax. What, you say? How did it get a license? Well, the vaccine licensed in 1970 was quite different from the current vaccine, which is approximately 100 times stronger, according to the Government Accountability Office's report to Congress. But even the 1970 vaccine lacked evidence of human efficacy. Philip Coleman of CDC admitted there was "no real method of determining the protection afforded."

The ad hoc committee that reviewed the licensing data for anthrax vaccine for NIH, pointed out that the lack of cases of anthrax in an Alabama mill whose workers were vaccinated was hardly evidence of efficacy, since there was no evidence anyone at the mill had been exposed to anthrax. Dr. Margaret Pittman of NIH signed a letter to the manufacturer, the Michigan Department of Public Health, granting the license anyway, but asking Michigan to perform a clinical trial demonstrating efficacy. Yet there is no evidence the trial was ever conducted.

Everyone knew the vaccine might or might not work, but looked the other way. In 1985, the army decided to try and obtain a live spore anthrax vaccine instead, issuing a request for proposals, and admitting that "there is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent." The army proposal request also acknowledged that the current "vaccine is, however, highly reactogenic, requires multiples boosters to maintain immunity and may not be protective against all strains of anthrax bacillus." No live spore vaccine was ever licensed, however, in the United States, although similar vaccines are used in Russia and China.

Also in 1985, the FDA's advisory committee that reviewed the anthrax vaccine license to determine if the license was warranted by the evidence, pointed out that the efficacy of the vaccine against inhalation anthrax could not be determined. Their report was published in the December 13, 1985 Federal Register--but FDA decided to continue the license nonetheless.

In 1995 the military's Joint Program Office for Biological Defense published an information paper on anthrax vaccine that, again, admitted "there was insufficient data to show protection against inhalation anthrax" and that the vaccine's inability to protect against some anthrax strains "limits the breadth of efficacy claims that can be made. To date, no animal or other potency test has been demonstrated to be well correlated with protection in humans." This is an important concept: scientific studies over the past twenty years have uniformly failed to find a way to correlate animal data with human efficacy, so animals studies cannot be used to support the vaccine license. Yet animal studies are all the Defense Department and FDA have to go on--which fails to meet current and past regulatory standards for licensure. Therefore, the current legal challenge to the vaccine's license has an excellent chance to prevail.

Still interested in the animal data? I reviewed all the mouse and guinea pig data in a 1999 publication, showing that the US anthrax vaccine led to more animal deaths than the Russian and British human vaccines, and the US animal vaccine, when vaccinated rodents were later exposed to anthrax spores.

The Defense Department likes to tout their scientists' monkey studies, claiming a 95% survival rate in exposed, vaccinated rhesus monkeys. But what DOD fails to acknowledge is that many of the vaccinated monkeys actually did get anthrax, and were ill for up to two weeks. (Did the Army scientists keep them on life support?) Not only that, the monkeys were given human doses of vaccine, even though they only weighed about ten pounds. This would be equivalent to humans getting almost twenty doses of vaccine at a time. Would you call this a fair trial? Yet it is this type of data that the Army uses to "prove" the vaccine's effectiveness.

In a nutshell, anthrax vaccination successfully immunizes only the Defense Department's medical officers, and no one else--immunizing them against possible future charges of negligence, if troops ever did face anthrax. It gives the leaders cover, so they can say, "We did our best to protect the troops," even though they know perfectly well this vaccine is unfit for human consumption, and its only value has been to Bioport/Emergent Biosolution's bottom line.

But that isn't the end of this sorry tale. Bioport/Emergent Biosolutions, the vaccine's manufacturer, has spent over 2 million dollars in 2006 alone, to lobby the government to purchase this vaccine for civilians, too. Guess what? A former US Surgeon General, an Army Surgeon General, a former head of the Joint Chiefs and other former Generals have been on Bioport's payroll. Their lobbying has succeeded: 10 million doses have already been delivered to the National Strategic Stockpile, and now the Department of Health and Human Services has proposed buying another 20 million more, at a current cost of approximately $500 million. Civilians could face mandatory anthrax vaccinations in future, if the HHS Secretary (or governors of states that have passed enabling legislation) declared an emergency or a potential anthrax emergency, as a result of legislation passed hurriedly in the wake of 9/11.

When will the responsible federal agencies within DOD and HHS finally come to grips with this vaccine's dreadful performance and checkered history and junk the license and the stockpile?