September 29, 2006

Fort Detrick Poses a Threat to Frederick, Md.--and to Humanity


A huge expansion of bioweapons research at Fort Detrick in Frederick, Maryland, is being planned as part of President Bush's $8 billion annual budget for bioweapons research ( This expansion is ill advised for the following reasons:

1. NO LOCAL SECURITY: “You could walk out with anything,’ researcher says,” “Scientist faults lab’s security;” (Frederick Post, 1/21/02): “Interviews with more than a dozen current and former Fort Detrick scientists provided a rare account of what they described as a lax security system, that could have done little to prevent an employee from smuggling the ingredients for biological terrorism out.” Also, see “Detrick lost pathogens: Army audit,” (front page, Frederick Post, 1/21/02): “Lab specimens of anthrax spores, Ebola virus and other pathogens disappeared during a turbulent period of labor complaints and recriminations among rival scientists...” Also, see “Beyond the breach,” (front page, Frederick Post, 5/13/06): “During a two-week period in April four years ago, officials at the Army’s lead biodefense laboratory at Fort Detrick discovered anthrax spores had escaped carefully guarded suites into the building’s unprotected areas.” Also, see “Risky Business,” (Frederick Post, front page, 5/14/06): “Employees at USAMRIID, the Army’s leading biodefense laboratory, filed 161 biological defense mishap reports between April 1, 2002 and Dec. 1, 2005.” Dangerous pathogens, some with no cure, could escape in the event of accident, terror attack or an inside job like the October 9, 2001 anthrax attack on Democratic Senators. The latter intimidation helped stampede the Patriot Act passage and terrorized Congress into authorizing war (

2. NO MEDICAL PRIORITY: In March, 2005, 750 US biologists signed a letter protesting what they see as the excessive study of bioterror threats. "The diversion of research funds represents a crisis for NIH-supported microbiological research," the letter states. Signers include two Nobel laureates and seven past presidents of the American Society for Microbiology. Real medical threats are going unfunded, such as staphylococcus, which is now largely unaffected by penicillin and other antibiotics (“Superbugs,” USA Today, 5/11/06). The NIH budget for medical research priorities has been slashed to help pay for bioweapons research--yet any bioterror threat pales in significance compared with diseases which already kill tens of thousands: (“Rising Diabetes Threat Meets a Falling Budget," NYT,5/16/06). Dr. Muin Khoury, Director of Disease Prevention at the CDC, stated in February 2003, ”Public health is in disarray, and this emphasis on terrorism is eroding the public health infrastructure even more.”

3. NO CREDIBLE BIOTERROR THREAT: Milton Leitenberg, a veteran arms control advocate and senior scholar at the University of Maryland’s Center for International and Security Studies, shows in his recently published Assessing the Biological Weapons and Bioterrorism Threat that billions of federal expenditures have been appropriated in the absence of virtually any threat analysis, and that the risk and imminence of the use of biological agents by nonstate actors/terrorist organizations “has been systematically and deliberately exaggerated.” It is critical to recognize that the only bioattack in American history, namely the anthrax letters of October 2001, almost certainly was generated by our own bioweapons establishment. Dr. David Franz, former director of the Army's bioweapons facility at Detrick (USAMRIID): “People don’t understand how difficult it is to pull off a biological attack.” Dr. C.J. Peters, formerly a senior virologist at USAMRIID: For a chemical or biological attack with mass casualties, “You have to have a state or the equivalent.”

4. NO MONEY: Federal deficit spending is pushing the national debt to beyond bankrupting levels. Military bases and weapons systems are being cut as branches vie for funding. So, cut Ft. Detrick!

5. NO WATER: Frederick has just contracted to help pay for an expensive pipeline 30 miles to the Potomac River (containing dioxin, PCBs, mercury and fecal bacteria). During droughts, D.C. can bar others from drawing from the Potomac, leaving Frederick to compete with Fort Detrick for Monocacy River water, also inadequate during droughts. Larger water bills are on their way, not to speak of higher taxes for more schools, roads and waste treatment. Already, many residents can no longer afford to live here.

6. NO LEGALITY: The former chief American negotiator of the Biological Weapons Convention, James Leonard, has warned that the administration’s initiative could be interpreted as “development” of biological weapons in violation of the Biological Weapons Convention (BWC). This explains the Bush administration’s rejection of the International Protocol on Inspection and Verification of biological weapons activity, supported by practically all of the other 130 nations that are party to the BWC.

7. NO INTERNATIONAL SECURITY: Testing clouds of genetically modified pathogens on animals is worrisome because if we found these things elsewhere in countries we were suspicious of, we would not say they had a necessary biodefense program. One might conclude that the US bioweapons program could ignite similar efforts in other countries, fueling a biological arms race and the proliferation of genetically modified pathogens. If diseases with no vaccines or cures escape anywhere in the world, national boundaries would not mean much, as the HIV/AIDS epidemic shows. The US bioweapons program therefore threatens our global and national security.

8. NO LIMIT: Germ warfare agents can be genetically modified and each modification may require a different vaccine or countermeasure. Since Fort Detrick's stated mission is to anticipate biological threats, Fort Detrick plans to genetically modify diseases on which to test vaccines. This is a slippery slope to a bottomless pit of unlimited new diseases with no known cures, which could plague the earth till the end of time, if they escaped containment by accident, smuggling or terror attack. These technologies may very well end up under the control of the “enemy,” technologies that the “enemy” would never be able to develop on its own.

9. NO INTEGRITY: The situation is ripe for biotech corporate profiteering, and political bribery, to further warp the democratic process with pork and even germ scares for profit. The rampant corruption associated with the failures of reconstruction in Iraq and post-Katrina portends the development of a disease protection racket.

10. NO CREDIBILITY: The difference between defensive and offensive R&D is defined by intention. There is little reason to believe that the Bush administration's intentions with respect to expansion of bioweapons facilities are purely defensive. The Army has had to admit that it has been using chemical weapons in the current war in Iraq. Such use of white phosphorus and napalm is in clear violation of the Chemical Weapons Convention, to which the U.S. is a party. Some history: In the 1980s, the U.S. Department of Commerce licensed 70 biological exports to Iraq. Saddam was our ally then, warring against our enemy Iran. Licensed exports included approved shipments to Iraq of weapons grade botulin poison and at least 21 batches of lethal strains of anthrax. (

11. NO TRUST: The Administration lied this nation into the war on Iraq, mismanaged the Katrina disaster, rejects World Court decisions, ignores the Convention Against Torture, opposes the Koyoto treaty on greenhouse gases, boycotted the South African Conference on Racism, defends and finances Israel's UN violations, rejects the Land Mines Treaty, violates the Nuclear Non-Proliferation Treaty, the Anti-Ballistic Missile Treaty and the Treaty Against Militarization of Space. This Administration has violated the UN Charter by aggression and occupation of a country which posed no threat to the US. The United Nations Chairman Kofi Annan has called this US war "illegal." After all this, why should anyone trust their germ warfare intentions in Frederick?

Barry Kissin is an attorney practicing in Frederick, Md. Richard Ochs, a retired printer, is a longtime Baltimore peace and environmental activist.

September 28, 2006

FBI Denies Overestimating Anthrax Power

FBI Denies It Overestimated Potency of Anthrax Spores Used in Mailings That Killed 5 in 2001, By MICHAEL J. SNIFFEN, Associated Press

WASHINGTON Sep 28, 2006 (AP)— The FBI denied Thursday that it ever overestimated the potency of the anthrax spores used in mailings that killed five people in 2001.

The bureau also rejected a request for a classified briefing on the case from Rep. Rush Holt, D-N.J. Citing media reports, Holt said Wednesday that the FBI should have determined in days, not years, that the anthrax was less sophisticated than initially believed.

Shortly after the attacks, media reports said the spores contained additives and had been subjected to sophisticated milling both techniques used in anthrax-based weapons to make them more lethal. Earlier this month, there were media reports that the FBI belatedly learned that those techniques were not used and the anthrax was not enhanced.

Bureau officials say the early reports of weaponized anthrax were misconceptions, and the more recent reports misunderstood how early the FBI was able to accurately analyze the spores.

"The FBI and its partners in this investigation have never been under any misconceptions about the character of the anthrax used in the attacks," Assistant FBI Director Eleni P. Kalisch wrote Holt on Thursday. "On the contrary, since the earliest months of this investigation, we have consulted with the world's foremost scientific experts on anthrax and relevant bio-forensic sciences, both inside and outside the FBI. While there may have been erroneous media reports about the character of the 2001 anthrax, the FBI's investigation has never been guided by such reports."

In a letter Wednesday to FBI Director Robert Mueller, Holt had requested a classified briefing on the investigation.

Kalisch rejected that request on two grounds:

Although Holt and other members of Congress got updates and briefings in 2002 and 2003, Kalisch said the FBI and Justice Department decided to stop briefing members of Congress after sensitive investigative information was reported in the media citing congressional sources.

Because this is a criminal investigation rather than an intelligence activity, a briefing of the House Intelligence Committee, of which Holt is a member, would be inappropriate, Kalisch wrote.

In an interview, Holt responded, "The inference that any member of the intelligence committee was the source of previous leaks is outrageous, irresponsible and without foundation."

The case "clearly falls within the purview of the intelligence committee," Holt added. "Our job is to see that the government functions well and in the anthrax investigation our government has not functioned well."

In 2001, anthrax contamination was found in mail facilities in and near Holt's central New Jersey district and in his office on Capitol Hill.

Holt had written Mueller that the FBI's delay in determining what kind of anthrax was used meant that "resources were diverted and countless agents wasted their time investigating a small pool of suspects, instead of the broader search we now know was needed."

The FBI has conducted 9,100 interviews and issued 6,000 subpoenas in the case.

Holt asked Mueller to have Douglas Beecher, a scientist in the FBI's Hazardous Materials Response Unit, testify before the House Intelligence Committee.

In April, Beecher wrote an article published in a scientific journal in August saying there was "a widely circulated misconception" that the anthrax spores were made using additives and sophisticated engineering akin to military weapons production.

The anthrax attacks, in the days after Sept. 11, 2001, killed five people across the country and sickened 17. There were five confirmed anthrax infections and two suspected cases in New Jersey but no fatalities.

FBI Denies Overestimating Anthrax Power

FBI Denies It Overestimated Potency of Anthrax Spores Used in Mailings That Killed 5 in 2001, By MICHAEL J. SNIFFEN, Associated Press

WASHINGTON Sep 28, 2006 (AP)— The FBI denied Thursday that it ever overestimated the potency of the anthrax spores used in mailings that killed five people in 2001.

The bureau also rejected a request for a classified briefing on the case from Rep. Rush Holt, D-N.J. Citing media reports, Holt said Wednesday that the FBI should have determined in days, not years, that the anthrax was less sophisticated than initially believed.

Shortly after the attacks, media reports said the spores contained additives and had been subjected to sophisticated milling both techniques used in anthrax-based weapons to make them more lethal. Earlier this month, there were media reports that the FBI belatedly learned that those techniques were not used and the anthrax was not enhanced.

Bureau officials say the early reports of weaponized anthrax were misconceptions, and the more recent reports misunderstood how early the FBI was able to accurately analyze the spores.

"The FBI and its partners in this investigation have never been under any misconceptions about the character of the anthrax used in the attacks," Assistant FBI Director Eleni P. Kalisch wrote Holt on Thursday. "On the contrary, since the earliest months of this investigation, we have consulted with the world's foremost scientific experts on anthrax and relevant bio-forensic sciences, both inside and outside the FBI. While there may have been erroneous media reports about the character of the 2001 anthrax, the FBI's investigation has never been guided by such reports."

In a letter Wednesday to FBI Director Robert Mueller, Holt had requested a classified briefing on the investigation.

Kalisch rejected that request on two grounds:

Although Holt and other members of Congress got updates and briefings in 2002 and 2003, Kalisch said the FBI and Justice Department decided to stop briefing members of Congress after sensitive investigative information was reported in the media citing congressional sources.

Because this is a criminal investigation rather than an intelligence activity, a briefing of the House Intelligence Committee, of which Holt is a member, would be inappropriate, Kalisch wrote.

In an interview, Holt responded, "The inference that any member of the intelligence committee was the source of previous leaks is outrageous, irresponsible and without foundation."

The case "clearly falls within the purview of the intelligence committee," Holt added. "Our job is to see that the government functions well and in the anthrax investigation our government has not functioned well."

In 2001, anthrax contamination was found in mail facilities in and near Holt's central New Jersey district and in his office on Capitol Hill.

Holt had written Mueller that the FBI's delay in determining what kind of anthrax was used meant that "resources were diverted and countless agents wasted their time investigating a small pool of suspects, instead of the broader search we now know was needed."

The FBI has conducted 9,100 interviews and issued 6,000 subpoenas in the case.

Holt asked Mueller to have Douglas Beecher, a scientist in the FBI's Hazardous Materials Response Unit, testify before the House Intelligence Committee.

In April, Beecher wrote an article published in a scientific journal in August saying there was "a widely circulated misconception" that the anthrax spores were made using additives and sophisticated engineering akin to military weapons production.

The anthrax attacks, in the days after Sept. 11, 2001, killed five people across the country and sickened 17. There were five confirmed anthrax infections and two suspected cases in New Jersey but no fatalities.

New Anthrax Vaccine Shows Promise

The Associated Press
Wednesday, September 27, 2006; 8:49 PM

SAN FRANCISCO -- Five years after anthrax attacks left five dead and terrified America, scientists are reporting progress on developing a new vaccine they hope will work faster and with fewer side effects than the current one.

The experimental vaccine cleared two big hurdles in its first round of human tests, involving two doses given in a single month: No safety problems emerged, and it produced responses that suggest people were developing immunity to anthrax, its British manufacturer reported Wednesday.

The federally funded study involved 111 healthy adults and tested a vaccine developed by Avecia, a suburban London company, and the Defense Science and Technology Lab, part of the British Ministry of Defense.

More study is needed, but the early results are a good sign because problems continue to plague the California company with the main contract to develop a new vaccine, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

"We want to make sure we cover ourselves. You want to make sure you don't have everything invested in one particular product," especially one for a potential bioterrorism threat, he said.

Inventing a better vaccine has been a top goal since anthrax spores were sent through the mail five years ago, killing five, sickening 17, and causing a near panic nationwide. Many troops have refused to get the current vaccine, which is based on 1950s technology and requires six shots over 18 months to provide protection. Some soldiers sued to keep it from being required in the military.

To jump-start work on a new vaccine, scientists at the Army's research lab at Fort Detrick, Md., engineered a key ingredient they believed would make a vaccine less likely to cause skin irritations and other problems.

The government gave a California company, VaxGen Inc., an $877 million federal contract to produce vaccine based on the new approach, using three doses in six months. But the company has missed many deadlines and has pushed back delivery until at least 2008.

The government then gave Avecia a $71 million contract to develop an alternative vaccine using the same approach.

Results of Avecia's early human tests were reported Wednesday at a meeting of the American Society for Microbiology.

Volunteers were given two shots _ one at the start of the study and another three or four weeks later. Each shot contained one of various levels of the new vaccine or one of two levels of the current one.

At all doses, the new vaccine produced signs that people were developing immunity to the germ, though the early results suggest they may be a little weaker than the current vaccine's protection, said Dr. Andrew Simpson, a scientist at the British defense lab.

"The implication ... is that the immune response was not as good," said Dr. Arthur Friedlander, a senior scientist at the Army lab who did early work that led to the vaccine.

However, no one knows whether it is good enough, because even the current vaccine was never really tested against anthrax. It would be unethical to deliberately expose people to such a deadly germ, so scientists have relied on animal research to suggest what levels of immunity might protect people.

larger study of the Avecia vaccine, testing two or three doses and over longer time periods, is under way on 600 people in London and the United States, Simpson said.

"It is safe. We'd be quite happy to give it to more people in a larger trial," he said. "It's encouraging."

"They're making progress," Friedlander said. "It's certainly good having an alternative manufacturer."

Rogers' bioterrorism bill clears House

Lansing State Journal
By Katherine Hutt Scott

The U.S. House has approved a bill co-authored by Rep. Mike Rogers that would advance research and development of drugs, vaccines and other responses to bioterrorism and disease outbreaks such as avian flu.

The House approved the noncontroversial bill by voice vote late Tuesday. The measure still must clear the Senate and be signed by President Bush.

Sylvia Warner, a spokeswoman for Rogers, R-Brighton, said the bill would provide a boost to vaccine manufacturers, including Lansing-based BioPort Corp.

The company has a contract with the federal government to make anthrax vaccine for a stockpile of medicines that would protect Americans during a terrorist attack.

Bird Flu Vaccine Additive May Stretch Supply

Science Daily

Researchers have achieved an effective immune response to an avian influenza vaccine with doses as low as one-quarter of the norm when they added a chemical mixture known as MF59. The research is published in the November 1 issue of Clinical Infectious Diseases, now available online.

MF 59 is an adjuvant--a substance that increases the immune system's ability to respond to a stimulus. For this research, the investigators used inactivated H9N2 influenza vaccines--not the H5N1 virus currently feared as a potential pandemic strain. However, the study does suggest that if the feared pandemic comes to be, adjuvants might be used to extend the vaccine supply. Furthermore, the authors note, H9N2 is itself a pandemic threat.

The researchers vaccinated 96 young adults who were divided into eight groups receiving different dosage levels, half of the groups with and half without the MF59 adjuvant. The volunteers were tested for antibodies at 28 days and 56 days.

"Antibody in the blood to the influenza virus that you're trying to protect against is what protects people from getting the flu," said Robert Atmar, MD, lead author of the study. "What vaccines do is cause the vaccinated person to produce antibodies in their bloodstream. The higher the antibody levels, in general, the more likely people are to be protected from getting ill or from getting infected at all.

"What we found was that when the adjuvant material was included in the vaccine--at all dosage levels--the antibody response was significantly better, and as low as one-quarter the dose worked very well. And a single dose of the adjuvanted vaccine was as good as two doses of the vaccine without the adjuvant." This suggests that adjuvants might be used to stretch a limited vaccine supply and allow vaccination of greater numbers of people.

Neither group experienced serious reactions to the vaccines. However, mild pain or swelling was more common in the adjuvant group.

Note: After reading the above article, follow the below link:

September 26, 2006

HUGIN NEWS/Crucell and NIH VRC Announce Start of Ebola Vaccine Clinical Trial

Leiden, The Netherlands, September 26, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced that the Ebola vaccine it is developing in partnership with the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced its Phase I clinical study. The randomized, double-blind, placebo-controlled study in 48 healthy volunteers will test the single-shot vaccination in a dose-escalation trial.

The start of the trial follows the successful completion of the Investigational New Drug (IND) application process required by the Food and Drug Administration (FDA) in the US. In preclinical studies, a single shot of the PER.C6®-based vaccine protected monkeys completely against a lethal Ebola challenge. The Phase I study will be carried out by the VRC at the NIH Clinical Center in Bethesda, Maryland. The main factors under examination are the vaccine's safety, tolerability and immunogenicity.

"We are proud that another of our vaccines is progressing to the clinic, and the Ebola vaccine is the first employing our adenovirus vaccine technology to do so," said Jaap Goudsmit, Chief Scientific Officer at Crucell. "Crucell and the VRC have so far made significant progress together, and we now aim to take our partnership to the next level in developing a vaccine against this extremely dangerous disease."

About Ebola

The Ebola virus is one of the few viruses capable of causing hemorrhagic fever, a severe, often-fatal disease in humans characterised by high fever and massive internal bleeding. Among other hemorrhagic fevers including Marburg and Lassa, Ebola causes death in 50% to 80% of all cases. Ebola outbreaks occur regularly in tropical Africa, affecting both human and great ape populations. Since the Ebola virus was first recognized, approximately 2,000 cases with over 1,200 deaths have been reported. Ebola usually appears in sporadic outbreaks, and spreads within a health-care setting. Because of the high disease-related mortality rates and lack of any vaccine or therapy, the Ebola virus is on the US Centers for Disease Control and Prevention (CDC) category "A" list of bioterror agents, together with smallpox and anthrax.

About Crucell-VRC Partnership

Crucell has entered into a Cooperative Research and Development Agreement (CRADA) with the VRC ( to jointly develop, test, and manufacture an adenovirus-based Ebola vaccine. Under the terms of the agreement, Crucell has an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration. In August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections. In March 2005, Crucell secured an exclusive license to certain patents of the NIH for the development and commercialization of recombinant vaccines against Ebola, and a US$ 21.4 million manufacturing contract was signed with the NIH in April 2005, under which Crucell will manufacture its recombinant adenovirus vector Ebola vaccine for clinical trials in humans.

About Crucell

Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine and the only aluminium-free hepatitis A vaccine on the market. The Company has a broad development pipeline, including both early-stage products and products almost ready to go to market.

Several Crucell products are based on its unique PER.C6® production technology. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy and Korea. The Company employs about 900 people. For more information, please visit

Forward-looking statements This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on July 6, 2006, and the section entitled "Risk Factors". The Company prepares its financial statements under generally accepted accounting principles in the United States (US GAAP) and Europe (IFRS).

For further information please contact:

Crucell N.V. For Crucell in the US: Paul Vermeij Redington, Inc. Director Investor Relations and Corporate Thomas Redington Communications Tel. +1 212-926-1733 Tel. +31-(0)71-524 8718

(END) Dow Jones Newswires

September 26, 2006 02:18 ET (06:18 GMT)

September 25, 2006

FBI Is Casting A Wider Net in Anthrax Attacks

Washington Post
By Allan Lengel and Joby Warrick

Five years after the anthrax attacks that killed five people, the FBI is now convinced that the lethal powder sent to the Senate was far less sophisticated than originally believed, widening the pool of possible suspects in a frustratingly slow investigation.

The finding, which resulted from countless scientific tests at numerous laboratories, appears to undermine the widely held belief that the attack was carried out by a government scientist or someone with access to a U.S. biodefense lab.

What was initially described as a near-military-grade biological weapon was ultimately found to have had a more ordinary pedigree, containing no additives and no signs of special processing to make the anthrax bacteria more deadly, law enforcement officials confirmed. In addition, the strain of anthrax used in the attacks has turned out to be more common than was initially believed, the officials said.

As a result, after a very public focus on government scientists as the likely source of the attacks, the FBI is today casting a far wider net, as investigators face the daunting prospect of an almost endless list of possible suspects in scores of countries around the globe.

"There is no significant signature in the powder that points to a domestic source," said one scientist who has extensively studied the tan, talc-like material that paralyzed much of Washington in the deadliest bioterrorism attack in U.S. history.

The FBI says it remains optimistic that it will find whoever killed five people -- two of them from the Washington area -- in a series of bioterrorism-by-mail attacks that rocked a nation still in shock from the Sept. 11 terrorist strikes. The bureau has assigned fresh leadership to the case -- Special Agent Ed Montooth -- and retains a full-time investigative force of 17 agents and 10 postal inspectors. "There is confidence the case will be solved," said Joseph Persichini Jr., acting assistant director in charge of the FBI's Washington field office.

The prevailing views about the anthrax powder, meanwhile, have been coalescing among a small group of scientists and FBI officials over several years but rarely have been discussed publicly. In interviews and a recently published scientific article, law enforcement authorities have acknowledged that much of the conventional wisdom about the attacks turned out to be wrong.

Specifically, law enforcement authorities have refuted the widely reported claim that the anthrax spores had been "weaponized" -- specially treated or processed to allow them to disperse more easily. They also have rejected reports that the powder was milled, or ground, to create finer particles that can penetrate deeply into the lungs. Such processing or additives might have suggested that the maker had access to the recipes of biological weapons made by the United States in the 1950s and 1960s.

In fact, the anthrax powder used in the 2001 attacks had no additives, writes Douglas J. Beecher, a scientist in the FBI laboratory's Hazardous Materials Response Unit, in an article in the science journal Applied and Environmental Microbiology.

"A widely circulated misconception is that the spores were produced using additives and sophisticated engineering supposedly akin to military weapons production," Beecher writes in the journal's August edition, in what is believed to be the most expansive public comment on the nature of the powder by any FBI official. "The idea is usually the basis for implying that the powders were inordinately dangerous compared to spores alone."

The FBI would not allow Beecher to be interviewed about his article. But other scientists familiar with the forensic investigation echoed his description. Whoever made the powder produced a deadly project of exceptional purity and quality -- up to a trillion spores per gram -- but used none of the tricks known to military bioweapons scientists to increase the lethality of the product. Officials stressed that the terrorist would have had to have considerable skills in microbiology and access to equipment.

"It wasn't weaponized. It was just nicely cleaned up," said one knowledgeable scientist who spoke on the condition he not be identified by name because the investigation is continuing. "Whoever did it was proud of their biology. They grew the spores, spun them down, cleaned up the debris. But there were no additives."

Moreover, scientists say, the particular strain of anthrax used in the attacks has turned to out to be a less significant clue than first believed. The highly virulent Ames strain was first isolated in the United States and was the basis for the anthrax weapons formerly created by the United States. The use of the Ames strain in the 2001 attack was initially seen as a strong clue linking the terrorist to the U.S. biodefense network.

But the more the FBI investigated, the more ubiquitous the Ames strain seemed, appearing in labs around the world including nations of the former Soviet Union.

"Ames was available in the Soviet Union," said former Soviet bioweapons scientist Sergei Popov, now a biodefense expert at George Mason University. "It could have come from anywhere in the world."

Many law enforcement officials believe that ever-improving technology eventually could lead to a break in the case. Ongoing tests could lead authorities to the lab where the anthrax originated -- something authorities have said for years could help close the case.

More traditional tactics are still being used: The FBI has conducted 9,100 interviews and issued 6,000 subpoenas in one of the most exhaustive and expensive investigations in the bureau's history. Authorities say investigators continue to have a number of specific individuals in their sights, describing the suspect list as "fluid."

One prevailing theory among investigators is that the attacks came from within the United States rather than from an overseas terrorist organization.

However, a law enforcement official said, "we have not closed the door on any possibilities. There's a discrete number of individuals who continue to be investigated, both internationally and domestically."

Over the years, officials have publicly identified only one "person of interest," and that was more than four years ago. Steven J. Hatfill, a former Army scientist, has denied wrongdoing and has never been charged. He is suing the Justice Department, alleging that officials leaked false information about him that caused great harm.

Law enforcement officials won't talk about Hatfill.

Homeland Security Secretary Michael Chertoff, in a meeting this month with Washington Post reporters and editors, would not say whether any single individual continues to draw special attention as a "person of interest."

"I'm not telling you that right now the bureau is focused on someone or not focused on someone," Chertoff said. "There are in my experience a lot of instances where we might know or have a good reason to believe who committed a criminal act, but we may not be able to prove it. So when you say something is not solved, you should not assume from the fact that there is no criminal prosecution we don't have a good idea of what we think happened."

Persichini, of the FBI's Washington office, acknowledged frustrations but said that "no one in the FBI has for a moment stopped thinking about the innocent victims of these attacks, nor has the effort to solve this case in any way been slowed.

"While not well known to the public, the scientific advances gained from this investigation are unprecedented and have greatly strengthened the government's ability to prepare for -- and prevent -- biological attacks in the future," Persichini said.

Nonetheless, failure to solve the mystery has bred public skepticism.

"If the FBI's investigation has become a cold case, then it's time for [FBI Director Robert S. Mueller III] to acknowledge that and take steps to deal with it," said Sen. Charles E. Grassley (R-Iowa), a frequent critic of the FBI. "I'm concerned that the FBI may have spent too much time focusing [on] one theory of what happened and too little effort on the other possibilities."

Staff writer Spencer S. Hsu and staff researcher Meg Smith contributed to this report.

Samples Provide Fewer Clues Than Earlier Thought to Help Solve 2001 Anthrax Attacks

Global Security Newswire

Nearly five years after the anthrax mail attacks in the United States, FBI investigators have disclosed that many previously reported details about the deadly bacteria were incorrect, the Washington Post reported today (see GSN, Sept. 16, 2005).

Most notably, the spores used were not produced from an unusual strain of anthrax, nor were they “weaponized” with any special additives or processing, according to law enforcement officials.

While no arrests have been made following the deaths of five people who were exposed to anthrax through the mail, the FBI remains upbeat that it will uncover the perpetrators.

“There is confidence the case will be solved,” said Joseph Persichini, acting assistant director in charge of the FBI’s Washington field office.

The bureau has recently assigned a new leader to its investigative team of 17 full-time agents and 10 postal inspectors, the Post reported.

The quality of the spores used in the attacks was high, but not military-grade, according to authorities. The anthrax was not milled to make smaller particles or treated to make it more lethal, they said.

“It wasn’t weaponized. It was just nicely cleaned up,” said one scientist. “Whoever did this was proud of their biology. They grew the spores, spun them down, cleaned up the debris. But there were not additives.”

In addition, the source strain of the anthrax used in the attacks was widely available and therefore offers few clues of its origin, according to the Post.

“It could have come from anywhere in the world,” said Sergei Popov, a former Soviet biological weapons scientist who now works at George Mason University.

The massive investigation has produced one “person of interest” who has denied any involvement. Steven Hatfill, a former Army scientist has never been charged (see GSN, April 12).

The lack of other publicly identified suspects, however, does not mean the investigation is dead, Homeland Security Secretary Michael Chertoff told reporters earlier this month.

“There are in my experience a lot of instances where we might know or have a good reason to believe who committed a criminal act, but we may not be able to prove it. So when you say something is not solved, you should not assume from the fact that there is no criminal prosecution we don’t have a good idea of what we think happened,” he said (Lengel/Warrick, Washington Post, Sept. 25).

One former FBI official disagreed, however.

“No matter what anybody says, if it is five years out, and we are not even seeing any smoke from the investigation, then I would say definitely that this case is cold right now,” said Christopher Hamilton, a former FBI counterterrorism official now with the Washington Institute for Near East Policy. “This thing is just sitting out there with nothing happening” (Eric Rosenberg, Hearst News, St. Paul Pioneer Press, Sept. 24).

September 23, 2006

FDA Told U.S. Drug System Is Broken - Expert Panel Calls For Major Changes

Washington Post
By Shankar Vedantam

The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.

The analysis by the Institute of Medicine shined an unsparing spotlight on the erosion of public confidence in the Food and Drug Administration, an agency that holds sway over a quarter of the U.S. economy. The report, requested by the FDA itself, found that Congress, agency officials and the pharmaceutical industry share responsibility for the problems -- and bear the burden for implementing solutions.

The report represents a watershed moment after two years of controversy over the safety of such widely used drugs as pain relievers and antidepressants. The Institute of Medicine is part of the National Academies, chartered by Congress to advise the government on scientific and health policy issues. Its recommendations traditionally carry great weight.

The 15 experts drawn from academic and professional organizations were unanimous in endorsing the recommendations, which called for several major policy changes. Several of these have long been urged by drug safety advocates but have been resisted by the industry, Congress and the FDA itself. A number of them would require congressional approval.

The panel called for a moratorium on consumer advertising of newly approved classes of drugs until they have been on the market long enough for unrecognized side effects and risks to emerge. Packaging for new types of medications should also carry a special symbol, such as the black triangle required in Britain, to alert patients that the drug's safety profile would not be fully known until it had been more widely studied, the report said.

The FDA should reevaluate safety and effectiveness data of such new drugs within five years after initial approval, the panel added, and the agency needs new powers to impose fines and requirements on drugmakers. In addition, the report called for the agency to have authority to place a wider range of restrictions on drugs it deems risky.

Manufacturers should also be required to register all clinical trials they sponsor in a government-run database to allow patients and physicians to see the outcome of all studies, not just those published in medical journals, the report said. Studies that show positive results for a drug are more likely to be published by journals than negative ones.

The committee also took aim at FDA management, citing a history of intra-agency squabbling and conflicts of interest on the expert advisory panels appointed by the agency to review the scientific data on proposed new drugs and devices. A substantial majority of advisory panel members should have no ties to industry, it said.

"FDA's credibility is its most crucial asset, and recent concerns about the independence of advisory committee members . . . have cast a shadow on the trustworthiness of the scientific advice received by the agency," the report said.

To reduce turnover and political interference, the institute said, the FDA commissioner should be appointed to a fixed six-year term. Currently, the commissioner serves at the pleasure of the president.

Agency officials said they will take the report seriously but added that changes implemented over the past year meant that the report is somewhat out of date. Acting FDA Commissioner Andrew C. von Eschenbach said the agency is especially focused on improving its scientific, technological and communication methods.

The pharmaceutical industry echoed the agency's response.

"Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed," the Pharmaceutical Research and Manufacturers of America said in a statement. "After all, fewer than three percent of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years."

But Sen. Charles E. Grassley (R-Iowa), who has led a number of investigations into the workings of the FDA in recent years, said the agency's reaction to a report it had commissioned speaks volumes.

"The FDA appears to be focused on damage control rather than addressing its core problems," Grassley said in a statement. "As a science-based agency, the FDA is remarkable for its lack of introspection, second-guessing, and failure to assess its own performance and capabilities in a systematic way."

Much of the institute's report focused on a central gap in drug regulation: While the FDA demands strict data on efficacy and safety from clinical trials before approving a new drug, less attention is paid after the drug reaches the market.

A safety problem that occurs once in every thousand patients, for example, would be unlikely to show up in clinical studies of a few hundred people, but it could result in thousands of serious side effects once the drug is approved and being taken by millions. The current system for monitoring adverse effects is nowhere near as systematic as the evidence collected before approval, the report said.

Besides, said R. Alta Charo, a panel member and bioethicist at the University of Wisconsin at Madison, patients who participate in drug trials are carefully selected, and hardly typical of patients in the real world who usually suffer from more complex problems.

"A drug tested in a few hundred or thousand people is very different when used by millions, especially over long periods of time and in conjunction with other supplements," she said.

While the agency can negotiate with companies to conduct long-term, post-approval studies, there are glaring gaps in such information, the report said. This is partly why the report also recommended limits on advertising new drugs. The report's authors acknowledged, however, that limits on advertising could run afoul of constitutional free-speech guarantees.

Charo also cited "a lack of collaboration among divisions, tensions [and] inappropriate management" at the FDA, saying officials who focus on safety issues are chronically underfunded compared with those who handle new-drug approvals.

Part of the problem, the report said, is that the money paid by industry to help fund FDA's regulators, under a 1992 law designed to speed up new drug reviews, cannot under the law be diverted to FDA's safety division, which suffers from chronic underfunding.

"What the report does not do very well is explain that the vast majority of interactions at the center are successful," countered Steven Galson, who directs the FDA division that evaluates new drugs. Still, he added, "I accept the recommendation and see it as an opportunity to improve."

Scott Lassman, senior assistant general counsel for the drug industry group, said it would study the report carefully. He said that the industry is open to suggestions for greater transparency but that the FDA already has enough authority to act after drugs are approved.

The trade group also opposes mandatory registration of clinical trials because that would force companies to reveal trade secrets to competitors, Lassman said. Manufacturers also oppose restrictions on advertising, he said, adding that advertisements help educate patients about problems and treatments.

Study Condemns F.D.A.’s Handling of Drug Safety

New York Times

WASHINGTON, Sept. 22 — The nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety.

The report by the Institute of Medicine, part of the National Academy of Sciences, is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight. The debate heated up in September 2004 when Merck withdrew its popular arthritis drug Vioxx after studies showed that it doubled the risks of heart attacks.

Several senators have already proposed significant changes, some of which the report seems to endorse.

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

In a telephone conference with reporters on Friday, top F.D.A. officials struck an awkward balance between thanking the institute for its work and defending their own leadership. They said they needed to study the report before deciding which of its recommendations to endorse.

“While considerable work has been done over the past two years to improve our approach to drug safety, work still needs to be done,” said Dr. Andrew C. von Eschenbach, the acting commissioner of the agency and the nominee for commissioner.

An internal e-mail message sent Friday to agency staff members by Dr. Sandra L. Kweder, deputy director of the Office of New Drugs, was blunter, bemoaning the report’s criticism of what it described as the agency’s dysfunctional culture.

“It is a long, inflammatory section of the report that will certainly generate the most public attention and hit our people hard,” Dr. Kweder wrote, according to a copy provided to The New York Times.

Agency critics were elated.

“The new report validates what the watchdog community has been saying for the last two years,” said Senator Charles E. Grassley, Republican of Iowa, who as chairman of the Senate Finance Committee has overseen investigations into drug safety problems. “Problems are systemic, and solutions must reflect a new mind-set by the agency leadership.”

The drug industry, through its trade organization, reacted warily. “Though there is always room for improvements, it would be a mistake to accept the notion that the F.D.A. drug safety system is seriously flawed,” said Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America.

The Institute of Medicine is a nonprofit organization created by Congress to advise the federal government on health issues. The report was issued by the Committee on the Assessment of the United States Drug Safety System, led by Sheila P. Burke, deputy secretary and chief operating officer of the Smithsonian Institution.

The report described fierce disagreements between those who approve drugs and those who study their effects after approval, disputes that repeated F.D.A. efforts have not resolved. Indeed, managers’ failure to address such disagreements competently “has played an important role in damaging the credibility” of the agency, it said.

Critics of the food and drug agency have long been divided into two warring camps. Some say the agency fails to approve life-saving medicines quickly enough, while others say that it is so intent on rapid approvals that it fails to ensure the safety of the drugs.

The institute’s report champions the latter view by calling for greater caution. It suggests that one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

“Some also have serious concerns that the regulator has been ‘captured’ by industry it regulates, that the agency is less willing to use the regulatory authority at its disposal,” the report said, criticizing the agency’s regulatory tools as “all-or-nothing.”

“The agency needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs, or to compel additional studies in the actual patient populations who take the drug after its approval,” it said.

The pharmaceutical industry is likely to fight at least some of the proposals, said Charlie Cook, a Washington political analyst.

“One should never underestimate the influence of the drug industry,” Mr. Cook said. “But I would think that at least the outlines of many of these recommendations would have a decent chance of getting through Congress.”

Senators Michael B. Enzi, Republican of Wyoming and chairman of the Health, Education, Labor and Pensions Committee, and Edward M. Kennedy of Massachusetts, the ranking Democrat on the committee, have jointly proposed a bill that would undertake at least some of the changes advocated by the report.

Another bill, sponsored by Senator Grassley and Senator Christopher J. Dodd, Democrat of Connecticut, offers similar proposals.

There is little chance that Congress will act on any of these proposals before next year, when it must reauthorize the 1992 financing deal with the drug industry. Negotiations between the drug industry and agency about the parameters of that deal are already under way.

Despite its fierce criticisms, the report may bolster the confirmation prospects of Dr. von Eschenbach. A Senate committee approved his nomination on Wednesday, but two Republican senators have vowed to block it.

Over the past 10 years, no commissioner has served more than two years, though the term is open-ended. The report deplored this “lack of stable leadership.”

“Without stable leadership strongly and visibly committed to drug safety, all other efforts to improve the effectiveness of the agency or position it effectively for the future will be seriously, if not fatally, compromised,” the report states.

It recommends that the commissioner be nominated for a six-year term, but such a change may not solve the problem of early exits. President Bush has nominated two past commissioners. The first left for another job within the administration; the second left amid accusations of financial improprieties.

The report recommends that Michael O. Leavitt, the secretary of health and human services, appoint an independent board to advise the commissioner “to implement and sustain the changes necessary to transform” the agency’s culture.

It rejects suggestions by Mr. Grassley and others that the F.D.A. create a center for drug safety to monitor drugs after approval.

“Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate organizations were working in isolation from one another,” the report concludes.

The F.D.A. asked the Institute of Medicine to review its drug safety system shortly after the Vioxx withdrawal in 2004, and the agency has agreed to pay $3 million for the study.

September 22, 2006

House Committee Passes Biological Defense Measure

By Kristen A. Lee, CongressDaily

WASHINGTON — The House Energy and Commerce Committee on Wednesday passed legislation to promote countermeasures to bioterrorism and other public health threats (see GSN, Sept. 12).

The Biodefense and Pandemic Vaccine and Drug Development Act of 2006, expands on Project BioShield, which was signed into law two years ago.

Global Security Newswire

The bill establishes a point of authority in the federal government — the Biomedical Advanced Research and Development Authority — to coordinate and facilitate efforts to develop countermeasures for bioterrorism or pandemic infectious diseases.

The legislation, which passed on voice vote, also authorizes $160 million in fiscal 2007 and fiscal 2008 for advanced research and development.

Representative Anna Eshoo (D-Calif.), who cosponsored the legislation with Representative Mike Rogers (R-Mich.), cited the threat of avian influenza or another anthrax attack as reasons for the bill's passage.

House Energy and Commerce Health Subcommittee Chairman Nathan Deal (R-Ga.) offered a substitute amendment that made technical changes to the bill. The manager's amendment also passed by voice vote.

Bioshield dispute underscores problems with defense program

The Associated Press

SAN FRANCISCO Five years after anthrax attacks left five Americans dead, sickened 17 and terrified the country, millions of vaccine shots developed through cutting-edge genetic engineering were supposed to be filling a new U.S. stockpile of biodefense drugs.

Instead, the nearly $1 billion (€780 million) contract awarded by the U.S. Department of Health and Human Services to a tiny and struggling San Francisco Bay area biotechnology company is plagued with misfortune and delays.

Delivery has been put off until at least 2008 — and maybe later — while the government and VaxGen Inc. trade barbs over who is at fault for the delays. The dispute has further tarnished Project BioShield, a government program that has alienated many potential biodefense contractors.

"We have all come to understand that there is more complexity than it originally appeared," said Thomas Ingelsby, deputy director of the University of Pittsburgh's Center for Biosecurity.

In 2001, someone sent anthrax through the mail, killing four people across the country who were exposed to the spores and sickening 17. Lawmakers then passed Project Bioshield, which promised to build national drug stockpiles to combat bioterrorism.

The project was supposed to jump-start a national security renaissance among drug makers by guaranteeing contracts to develop drugs for combatting potential bioweapons. But it has been greeted with skepticism by many in the industry.

The anthrax project, the first and largest BioShield contract, was to be the crown jewel.

In November 2004, the $877.5 million (€684.6 million) contract was awarded to VaxGen to genetically engineer a replacement for the current anthrax vaccine, which requires six shots to be administered over 18 months. VaxGen's is expected to require no more than three shots.

Since winning the contract, however, VaxGen has repeatedly stumbled, starting with its disclosure it would miss the original deadline of November 2005 by a year.

Even before winning the contract, the Brisbane, California-based company had a checkered past highlighted by the 2003 flop of its experimental AIDS vaccine, which failed to protect volunteers from infection.

Since then, it was dropped from the Nasdaq Stock Market for failing to file financial reports, its chief scientific officer left the company in July, and its shares hover near their 52-week low as VaxGen and the government try to work out their differences.

Then, in March, the government said it would not pay VaxGen until the company completed a costly and time consuming human test to ensure the vaccine was safe. The new requirement forced the company to sell its stake in another biotechnology company for $79 million (€61.6 million) to stay afloat and finance the new test.

"We don't get paid until we deliver product and we have to shoulder the carrying cost," said VaxGen spokesman Lance Ignon. "The burden it puts on our company is abundantly clear to Wall Street as shown by our stock price."

For its part, VaxGen blames the government for the latest delays.

"The heart of the problem right now is the government's willingness to change the goal line," Ignon said. "The government unilaterally, and without compensation to VaxGen, changed the contract."

The government counters that the safety data was always required and that it made minor changes that allowed VaxGen to deliver the vaccine later than it had initially promised.

VaxGen's difficulties underscore the industry's disappointment with BioShield, which has done little but generate indifference among the big pharmaceutical companies the government hoped to woo. Instead, drug makers are snubbing the program because of liability and intellectual property issues and confusion over what the government wants.

New legislation that would address many of the critics' concerns — such as protecting drug makers from liability lawsuits — has been bottled up in Congress for months and the prospect of a bill passing this year are dimming.

Big pharmaceutical companies, which can spend upward of $1 billion (€780 million) developing a single drug that can earn billions annually, are also turned off by the relatively paltry $5.6 billion (€4.4 billion) available under BioShield, analysts said.

Pharmaceutical Research and Manufacturers of America, the Washington-based trade group that represents drug makers, would not comment on why its members have shunned Project Bioshield but said it supports the program.

"PhRMA continues to work closely with the Congress and the Administration to help ensure that America has the necessary tools to help prepare for and respond to a possible bioterror attack," senior vice president Ken Johnson said in a statement.

Producing defensive measures has been largely left to small, financially struggling companies such as the oft-troubled VaxGen.

Despite its laundry list of failures, HHS has defended VaxGen's qualifications.

"The incentive is not there for the large pharmaceutical companies," said Noreen Hynes, director of research and development coordination in the HHS office responsible for biodefense. "Biotech companies, for the most part, are more inexperienced."

Since awarding the contract to VaxGen, HHS has doled out another $1 billion (€780 million) in contracts, including two this year worth a combined $505 million (€394 million) by the Canadian company Cangene Corp. for another anthrax treatment, as well as a drug to treat botulism.

None of the other drug developers have stumbled as spectacularly as VaxGen.

"The fact that a company doesn't deliver is always disappointing," Hynes said. But in vaccine and biological development, "delays are more the rule than the exception."

September 21, 2006

Bioterrorism Drugs Join Congress's Agenda

Firms Urge $1 Billion Fund For Vaccines, Treatments For Anthrax, Smallpox, Pandemic Flu

WASHINGTON -- As military tribunals and wiretapping dominate Congress's pre-election agenda, biotech companies are pushing lawmakers to enact a less divisive -- and more lucrative -- homeland-security measure: a $1 billion fund for vaccines and treatments for anthrax, smallpox and pandemic flu.

Since the anthrax attacks in October 2001, the biotech and venture-capital industries have seen new potential in developing products against bioterrorism.

Kleiner Perkins Caufield & Byers, a Menlo Park, Calif., venture-capital firm that has been lobbying for the measure, earlier this year formed a $200 million fund focused on development of vaccines and drugs for flu and bioterrorism threats. Small biotech firms, often with grants from the National Institutes of Health, or NIH, are scrambling to advance their research on products that the government might be interested in buying. Big drug makers are expressing interest in pairing with smaller players. But without greater support from the government, industry leaders say it is difficult, if not impossible, to bring their products to market.

The industry's campaign has drawn bipartisan backing. Senate legislation, sponsored by Sen. Richard Burr (R., N.C.) and several other Republicans, has the backing of Democrats such as Sen. Edward Kennedy of Massachusetts, home to a burgeoning biotechnology industry. In the House, similar legislation is sponsored by a handful each of Republicans and Democrats. The House Energy and Commerce Committee passed the legislation yesterday and the full House is expected to take up the bill soon.

But for all the momentum, the bill could stall amid a tight schedule on Capitol Hill and a climate in which Republicans and Democrats already are squabbling over counterterrorism measures. Yesterday, Republican leaders made bumpy progress on their national security agenda. President Bush's push for broader authority to conduct warrantless wiretapping was approved by the House committee that oversees intelligence. Meanwhile, the House Judiciary Committee initially rejected Mr. Bush's plan for interrogating and prosecuting suspected terrorists, as all Democrats and two Republicans opposed it. Then the committee voted again, after summoning absent Republicans, and passed the measure, 20 to 19.

Republican leaders in the Senate had planned to bring the bioterrorism measure to the floor this week, provided it could be done quickly without Democratic objections or amendments. But, while Democrats say they want to pass the measure, they also want the chance to improve it, said Jim Manley, spokesman for Democratic Leader Harry Reid of Nevada. He said Democrats aren't stalling to deprive Republicans of an antiterror legislative victory before the elections. "People on both sides of the aisle want to try to pass it as quickly as possible," Mr. Manley said.

Among the issues Democrats want to bring up: revisiting liability protections for vaccine makers that were provided in a spending bill late last year and beefing up the focus in the bill on emergency planning for at-risk populations, such as the elderly.

Mr. Burr, for his part, thought the bill had been vetted sufficiently. "This has two years of work put into it. Most objections of any significance have been addressed," he said.

The $1 billion fund is supposed to alleviate some of the problems with Project BioShield, a $5.6 billion program enacted in 2004 that is criticized by both industry and lawmakers for being slow to disburse development funds for new vaccines and other drugs to combat dangerous pathogens. Under the Senate proposal, a new agency would dole out the $1 billion in much the way venture capitalists do: in a series of increments as the recipients show progress, rather than in lump sums as practiced by BioShield's administrators at the Department of Health and Human Services. In addition, BioShield's mission would be expanded to include infectious diseases that could cause a public-health emergency, such as pandemic flu.

In recent years, as the biotechnology industry has grown, it has increased its visibility on Capitol Hill, both in terms of lobbying presence and campaign contributions. The Biotechnology Industry Organization, the industry's trade group, has as its president former Pennsylvania Republican Rep. James Greenwood. While individual companies such as Amgen Inc. are substantial political donors, it is mostly smaller, lesser known companies that have shown interest in entering the uncertain bioterrorism sector.

The $1 billion in grants that would be made available in the bioterrorism legislation is meant to address the "Valley of Death" that such smaller players say they face when trying to develop bioterrorism products. While the government has programs to fund early-stage research and late-stage procurement, companies say they need more support in the middle phase, when they conduct clinical trials and gear up manufacturing capabilities.

Current NIH funding, while crucial, "only takes us up to a certain point," says Peter Young, president and chief executive of AlphaVax Inc., a Research Triangle Park, N.C., company working on technology to deliver into the body vaccines for flu and illnesses caused by bioterrorism. Project BioShield is "insufficient" and "fragmented," Mr. Young adds.

Passage of the bill also would show that the government is committed to funding bioterrorism research and development -- a move companies said would give the private sector greater confidence. "It sends a signal and maybe allows us to raise more money" from the private sector, says Francesca Cook, vice president for policy and government affairs at PharmAthene Inc., an Annapolis, Md., company developing treatments for anthrax and smallpox.

The Senate bill also would address some concerns raised about the government's response to the health emergencies experienced after Hurricane Katrina. It designates the HHS secretary as the lead federal official in charge of responding to health emergencies.

Write to Sarah Lueck at

Judge neither vacates nor reiterates prior opinion - Anthrax Vaccine

Inside the Pentagon
By: Elaine M. Grossman
Page 1

Judge neither vacates nor reiterates prior opinion

Litigation over the Pentagon's anthrax immunization program fizzled toward an unexpected conclusion early this month when U.S. District Court Judge Emmet Sullivan opted to ignore an invitation from a three- judge appeals panel to consider vacating a decision he'd issued nearly two years ago. Instead, Sullivan said at a Sept. 7 hearing in Washington the only issue he sees remaining before his court is how much the U.S. government owes the plaintiffs in attorney's fees.

The case revolves around a Pentagon effort, begun in 1998, to inoculate more than a million defense personnel with the anthrax vaccine. Defense officials said the mandatory shots were necessary to ensure troops and civilians in high-risk regions or jobs do not fall victim to potentially lethal biological attacks. The Defense Department sought to use the vaccine to protect against "weaponized" anthrax spores an adversary might spread through the air.

Six anonymous defense personnel challenged the program with a lawsuit, filed in March 2003, saying the Pentagon could not legally administer the six-shot inoculation series involuntarily because the anthrax vaccine had never been properly licensed for wide-scale protection against inhaled transmission of the disease. Under the law, a U.S. president could invoke national security concerns and override a service member's right to decline inoculations, but neither President Clinton nor President Bush did so.

Rather, the government has defended the mandatory shots, insisting the vaccine was properly licensed.

In an October 2004 summary judgment on the case, Sullivan supported the plaintiffs, declaring the Pentagon's involuntary vaccination effort to be "illegal" (Inside the Pentagon, Oct. 28, 2004, p1). Sullivan issued a permanent injunction against giving mandatory shots until such time as the Food and Drug Administration carried out a proper process to certify the anthrax vaccine, or a presidential waiver is issued.

In response, the Defense Department temporarily suspended the shots. But in May 2005, the Pentagon resumed the effort on a voluntary basis, citing the authority of a relatively new law, the 2004 Project BioShield Act (ITP, May 5, 2005, p5).

Later that month, the government challenged Sullivan's decision at the U.S. Court of Appeals (ITP, May 19, 2005, p1). As the Justice Department's appeal was pending, FDA completed the formal process the lower court judge had said was necessary before the injunction against mandatory shots could be lifted. The agency issued a "final rule and order" last December confirming its view the anthrax vaccine is safe, effective and appropriate for the prevention of inhaled spores (ITP, Jan. 5, p1).

Based on FDA's long-awaited certification, the federal appeals panel decided in February that the government appeal before it had become moot. But in an interesting twist, the higher court remanded part of the case back to Sullivan. The appeals panel suggested Sullivan might rule on the government's pending request to vacate his 2004 finding that the Pentagon's anthrax inoculation program was illegal between its May 1998 inception and the FDA certification, issued in December 2005 (ITP, Feb. 16, p1).

"By its own terms . . . the injunction has dissolved, and this case no longer presents a live controversy on which we may pass judgment," the appeals court said in its five-paragraph decision.

"The government urges us to vacate the district court's opinion" that the Pentagon vaccination program was illegal until FDA issued its final rule and order in December 2005, the three judges stated. "We decline to do so, and instead remand with instructions to the district court to consider that request."

In court early this month, Sullivan said a joint proposal co-authored in July by the complainants and defendants essentially wraps up the case. In fact, the document summarizes different views the two sides have about how Sullivan should act on the case.

"Plaintiffs request that the court refuse the defendant's request for vacatur, and adopt the findings and holding expressed in its October 2004 order that the vaccine was not a drug approved for its applied use until the FDA properly completed its review of the vaccine and issued a final rule and order on Dec. 19, 2005," the joint proposal states. The government's repeated statements that the vaccine status was safe, effective and not misbranded all along "fly in the face of this court's specific factual determinations and rulings," the plaintiffs note.

However, in the same document, the government appears to concede that it could not reasonably expect Sullivan to vacate his own earlier judgment that the Pentagon's use of the vaccine was illegal prior to last year's FDA certification.

"In light of the Court of Appeals' finding of mootness, the government does not believe that any substantive issues remain in this case and that the case should be dismissed," the document reads.

The two parties agree that, because the government did not prevail at the Court of Appeals, it now owes the plaintiffs payment for attorney's fees.

This remains the only pending issue before Sullivan, the federal judge said with little explanation at the Sept. 7 hearing.

"Can the parties resolve the issue of attorney's fees?" he asked the litigants, offering to assign the case to a magistrate.

Ronald Wiltsie, representing the Justice Department, told Sullivan he anticipates the two parties could probably sort out the issue themselves, once the plaintiffs update a petition for fees initially submitted to the court in November 2004. The attorneys said they could probably agree on payment for plaintiff attorney fees by early next year.

After the hearing, Mark Zaid, who serves as plaintiff co-counsel, told ITP he would estimate their total fee request will top $312,000. In 2004, the plaintiffs also tallied expert fees of nearly $22,000.

Despite the seemingly ambiguous disposition of the case as remanded back to Sullivan's court, those opposed to the Pentagon's involuntary program are confident the judge's 2004 declaration that it was illegal will form a strong basis for further litigation.

"The appeal was mooted," says one attorney involved in the case, speaking on condition of not being named. "It doesn't affect Judge Sullivan's [2004] order at all."

Those following the issue anticipate hundreds of service members who received dishonorable discharges for refusing orders to take the anthrax vaccine will appeal to the Pentagon to correct their records. Members of the military are not required to obey illegal orders. In addition, these individuals may request back pay through the end of their enlistment period and possibly seek damages if the blemish on their records made it hard to find work in the civilian world. A small number of personnel may ask to be reinstated into the military, according to sources.

"Were the government to have to cover all associated expenses involving service members and civilians who were unlawfully disciplined due to the illegal vaccine program, the amount would likely be in the tens of millions [of dollars]," Zaid told ITP on Sept. 7.

Appeals to a service board for the correction of military or naval records are made on a case-by-case basis and cannot be done as a class, sources say.

Meanwhile, the Pentagon continues to give anthrax inoculations to defense personnel on a voluntary basis.

September 18, 2006

$5.6 Billion Anti-bioterror Drug Project Stalled


A U.S. effort to stockpile anti-bioterror drugs that was launched after the anthrax attacks in 2001 has now bogged down as two rival biotech companies battle for government dollars.

After five Americans were killed by anthrax, the U.S. launched Project BioShield, a $5.6 billion program to devise new drugs and vaccines for a variety of bioterror threats. The highest priority – and a $900 million outlay – was for an anthrax vaccine.

The government already had an anthrax vaccine to inoculate military personnel, but it required six shots over 18 months and could have nasty side effects, according to a front-page story in the New York Times.

There have been reports of serious complications, and the military halted mandatory vaccinations in 2004 after some soldiers filed lawsuits seeking to avoid getting the shots.

So Project BioShield sought to develop a new vaccine, and turned to a small biotech company, VaxGen, which had never taken a drug to market and had had financial troubles in the past.

The U.S. awarded an $887 million contract to Brisbane, Calif.-based VaxGen to produce 75 million doses of the vaccine, enough to inoculate 75 million Americans.
But that drew complaints from Emergent BioSolutions in Gaithersburg. Md., the maker of the old vaccine.

The company hired lobbyists to plead its case to the government, pointing to problems VaxGen was having developing a new vaccine and urging the U.S. to buy more doses of the old vaccine, Emergent’s only major product.

VaxGen countered by hiring lobbyists of its own, including Robert Houseman, who had worked for Emergent and then switched sides.

In May, the Department of Health and Human Services agreed to double its order of Emergent’s vaccine to 10 million doses, worth $243 million, the Times reports.

The agency also demanded additional safety and efficacy tests for VaxGen’s new vaccine that will further delay its delivery by a year or more.

Now VaxGen wants upfront payments from the health department and is threatening to sue. If the two sides can’t come to an agreement, company officials say, VaxGen could end the deal.

"This ought to be driven by the science, by efficacy and threat, not lobbyists,” said Houseman. "It has been shanghaied. And the implication is our national security is compromised.”

Bid to Stockpile Bioterror Drugs Stymied by Setbacks

New York Times
By Eric Lipton

WASHINGTON, Sept. 17 — The last of the anthrax-laced letters was still making its way through the mail in late 2001 when top Bush administration officials reached an obvious conclusion: the nation desperately needed to expand its medical stockpile to prepare for another biological attack.

The result was Project BioShield, a $5.6 billion effort to exploit the country’s top medical and scientific brains and fill an emergency medical cabinet with new drugs and vaccines for a host of threats. “We will rally the great promise of American science and innovation to confront the greatest danger of our time,” President Bush said in starting the program.

But the project, critics say, has largely failed to deliver.

So far, only a small fraction of the anticipated remedies are available. Drug companies have waited months, if not years, for government agencies to decide which treatments they want and in what quantities. Unable to attract large pharmaceutical corporations to join the endeavor, the government is instead relying on small start-up companies that often have no proven track record.

The troubles have been most acute with the highest priority of all: a $900 million push to add a new anthrax vaccine to the stockpile. What had begun as an effort to test and manufacture a safer, faster-acting vaccine has turned into an ugly battle between two biotech businesses.

Each has hired Washington lobbyists to attack its rival’s product and try to win over lawmakers and administration officials. Delivery of the new vaccine is far behind schedule, and a dispute between the Department of Health and Human Services and VaxGen, the company chosen to make the vaccine, could even end the deal. The only doses that have been added to the stockpile are of a decades-old vaccine that has generated complaints of serious side effects.

Health department officials acknowledge some problems but say they have made progress. “Medical discovery is an unpredictable process,” said Bill Hall, a spokesman. “It is the nature of science.”

But some companies on the sidelines say the experience with the anthrax vaccine is exactly why they do not want to do business with Washington. Once optimistic about the president’s promise, many biotech companies and public health experts are now discouraged.

“The inept implementation of the program has led the best brains and the best scientists to give up, to look elsewhere or devote their resources to medical initiatives that are not focused on biodefense,” said Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland.

Even some former department officials who helped create BioShield are dismayed.

“I find this all rather repugnant,” said D. A. Henderson, a former top bioterrorism official. “You have people here who, in the face of a problem of serious import, are using every tactic they can to line their own pockets.”

Risk and Disappointment

From the start, officials in Washington knew that Project BioShield would be a risky venture — for the government, the companies involved and even ordinary Americans, who might be asked to take relatively untested treatments in an emergency.

Officials hoped $5.6 billion in federal money would entice companies to develop new drugs and vaccines for anthrax, smallpox, botulism, Ebola and other deadly diseases.

Because of the perceived urgency of the threat, the project suspends some traditional standards. It allows new vaccines or drugs to be used in emergencies before completing the lengthy Food and Drug Administration approval process. Full testing on humans is also not required because it is too dangerous, even though that means no one will know with certainty whether the vaccines will work until used in a crisis.

For their part, the companies have to take all the risks of developing and manufacturing new products; they get paid only upon delivery.

At the top of the government’s threat list was anthrax, which killed five people, created panic and disrupted the mail system after letters filled with the powder were sent through the mail. No one has been charged in the attacks, which affected places including a tabloid publication in Florida, a New York television network and several lawmakers’ offices on Capitol Hill.

“The top three threats, in fact, are anthrax, anthrax, anthrax,” Dr. Gerald Parker, a senior health agency official, said in an interview. If properly dispersed through the air, just a few hundred pounds of anthrax powder could endanger tens of thousands of people.

After the letter attacks, the health agency bought enough antibiotics for 41 million Americans, but the recommended treatment augments those drugs with a vaccine. The government already had an anthrax vaccine to inoculate military personnel, but it involved six shots over 18 months, an unusually long course of treatment. While the F.D.A. says it is safe and effective, it can have nasty side effects. There have been reports among military personnel of six deaths and serious complications, including lymphoma and multiple sclerosis. The military stopped mandatory vaccinations in 2004 after some soldiers balked and filed lawsuits.

“It is 1950’s technology,” said Dr. Philip K. Russell, the former acting director of the office that started Project BioShield. “We don’t drive Model T Fords anymore.”

The first disappointment with the new anthrax vaccine occurred in early 2004 when bids to test and manufacture it came in. None were from big pharmaceutical companies; they considered the effort unappealing because the potential market was relatively small and profits limited. They were also concerned about liability if someone became ill or died after being inoculated. Project BioShield did not offer immunity from lawsuits.

That left a handful of companies in the running, relatively small outfits with limited experience. VaxGen, for example, had never taken a drug to market. Its first major product, an AIDS vaccine, flopped in 2003. The company also had financial troubles; it was barred from Nasdaq in 2004 after managers uncovered accounting errors.

The situation was hardly ideal, federal health officials acknowledged.

“We are going to be working consistently with these smaller firms, and it’s going to require an enormous amount of government effort to get this product licensed,” said Stewart Simonson, then an assistant health secretary overseeing the anthrax vaccine effort.

VaxGen argues that a company does not have to be large to successfully produce a vaccine. “We’ve repeatedly demonstrated that we have the capacity, expertise and infrastructure to meet the government’s needs,” said Lance Ignon, a vice president of the company, which is based in Brisbane, Calif.

Instead of hedging its bets by dividing the work among several vendors, Health and Human Services awarded the entire $887 million order to VaxGen. It was to produce 75 million doses, enough to inoculate 25 million Americans.

That decision fed doubts about Project BioShield in Congress and drew loud complaints that would grow into sharp opposition from Emergent BioSolutions, the maker of the old vaccine, which is based in Gaithersburg, Md.

Then known as BioPort and based in Lansing, Mich., the company did not submit a bid for the new vaccine. Instead, it had been trying for months to persuade the federal government to buy hundreds of millions of dollars of the existing vaccine, its only major product. When executives learned that one competitor was getting all the work, they knew the company’s future was in peril.

Soon, though, they found an important weapon for a campaign to recapture business.

Competition Heats Up

VaxGen’s vaccine was based on a modified version of the old one; Army scientists had genetically re-engineered it in hopes of making it safer and faster, with three shots instead of six. But VaxGen tests in early 2005 showed that an ingredient added to the vaccine caused it to decompose. It would not survive long in the emergency stockpile.

VaxGen officials played down the setback, which delayed delivery to 2007 from 2006. “We are being called on to develop a vaccine in roughly half the time it normally takes,” Mr. Ignon said. “When you do that, you have to accept the fact that there are going to be some unexpected turns.”

But Emergent officials capitalized on VaxGen’s stumble. They had already gotten health agency officials to agree to buy five million doses of their vaccine to add to the stockpile. Now they began pushing for a much larger deal, possibly replacing VaxGen’s vaccine altogether, company documents show.

To lead its lobbying effort, which has cost more than $1 million since 2005, Emergent turned to Jerome M. Hauer, a top official at the health department until late 2003. While at the agency, he supported the push for a new vaccine. Now he was trying to persuade Congress and his former employer to buy the old vaccine.

Explaining his shift, Mr. Hauer said VaxGen’s problems convinced him that Emergent’s vaccine was the best choice. In retrospect, he said, “The advice we were given was wrong.”

Emergent hired nearly a dozen other lobbyists, some of whom had similarly useful connections. They included John M. Clerici, a lawyer who had helped shape the BioShield legislation; John Hishta, former chief of staff to Representative Thomas M. Davis III, Republican of Virginia; and Allen Shofe, a former tobacco industry lobbyist.

The lobbyists argued that quality control problems at Emergent’s plant in Michigan had been corrected and that reports of serious side effects from the vaccine were unfounded. But mostly, they tried to undermine confidence in VaxGen.

In a series of meetings with lawmakers and administration officials, they attacked their rival. “VaxGen has a history of failure and irregularities,” their briefing books said. “VaxGen has never produced an F.D.A.-approved product,” and its “vaccine is based on unproven technology,” leaving “the health and protection of the American public on a company with a history of scientific failure and financial scandal.”

The lobbyists also criticized the officials involved in administering BioShield. In speeches and news interviews, Mr. Hauer questioned the credentials of Mr. Simonson, the health department official in charge of the program, and once called him the “Mike Brown of H.H.S.,” a reference to the disgraced former director of the Federal Emergency Management Agency. (Mr. Simonson, who resigned this year, had worked as an Amtrak lawyer and as legal counsel to Gov. Tommy G. Thompson of Wisconsin, who was later head of the federal health department.)

The lobbyists also charged that Dr. Russell, who helped start Project BioShield, had a conflict of interest. They said he had helped develop the vaccine as former director of the Walter Reed Army Institute of Research and then been instrumental in awarding the manufacturing contract after moving to the health department. (Dr. Russell says he retired from the Army before it began research on the VaxGen vaccine.)

Fearful of losing the public relations battle, VaxGen increased its own lobbying effort. It hired Robert Housman, who had worked with Mr. Hauer to help Emergent open its anti-VaxGen campaign and then switched sides. But VaxGen, which spent $200,000 on lobbying last year, was outmanned by Emergent and put on the defensive.

Senator Charles E. Grassley, an Iowa Republican and focus of Emergent’s lobbying, sent a letter to Health and Human Services Secretary Michael O. Leavitt that closely echoed criticisms of VaxGen that had first been raised in Emergent documents.

Representative Davis scheduled a hearing last summer at which Emergent’s chief executive was invited to testify, but no one was invited from VaxGen. Mr. Davis said Mr. Hishta, his former aide, apparently did contact his office about Emergent. But he said he was not sure why only Emergent was asked to testify.

Under pressure from Congress, the health agency agreed in May to double its order of Emergent’s vaccine to 10 million doses, worth $243 million. The next day, health officials demanded what VaxGen says are additional safety and efficacy tests that will further delay delivery by a year or two. Threatening to sue, VaxGen is seeking upfront payments from the health department or other concessions. If no agreement is reached, company officials say, the entire deal could collapse.

“We understand this program is new and changes will have to be made,” said Piers Whitehead, a vice president of VaxGen. “But in our case, the goalposts were moved much farther than they needed to be.”

Words of Determination

Health officials said they were determined to see the anthrax contract — and other BioShield endeavors — through to the end.

“There are people out there who feel like they are not getting a piece of the pie or that this is not running the right way,” said Mr. Hall, the department spokesman. “That may be. But to come in and criticize BioShield as a failing program because we have not spent all the money and don’t have all the products in the warehouse is completely and sorely misguided.”

The maneuvering has been so intense, with lobbyists and media consultants helping the companies undermine the competition, even some of the people who have profited now express disgust.

“This ought be driven by the science, by efficacy and threat, not lobbyists,” Mr. Housman said. “It has been shanghaied. And the implication is our national security is compromised.”

Next week, agency officials will meet with industry representatives to discuss a new strategy for Project BioShield. Mr. Greenberger, the University of Maryland expert, and others argue that government agencies must determine more quickly what is needed for the stockpile and provide more financial incentives to lure the big companies and better support the start-up companies.

Some in Congress say the improvements are much needed because Project BioShield has proven so disappointing.

“A torturous labyrinth of federal fiefdoms into which billions disappear,” Representative Christopher Shays, Republican of Connecticut, said of the program. “Yet few antidotes have yet to emerge.”

September 14, 2006

Jesse Lusian, age 24, died Sep 2nd, complications from anthrax vaccine
Wednesday, September 13, 2006

Jesse Lusian Age 24, died Saturday, September 2, 2006 from complications resulting from an anthrax vaccine he received while serving our country as a Merchant Marine on a cargo ship in Diego Garcia, a Navy Support Facility in the Middle East .

Jesse is survived by his father Robert Lusian of Hemet; mother, Colleen Lusian-Halbohm and stepfather, Bruce Halbohm of Cloverdale; grandmothers, Dorothy Lusian of Hemet and Shirley Evelyn Smyth of Hillsborough; brother, Ralph Lusian of Tuscaloosa, AL; aunts, Kerry Taylor of Santa Rosa and Eileen Gordon and her husband Bob of Daly City; uncle, Gerald Lusian; "Uncle Fred" Spencer and his wife Sharon; Aunt Nancy and Uncle Geno Franconi; Shelly Pedersen; cousins, Kelly Gordon, Billy Spencer, Debbie Gallegos, Karla and Frank Bobadilla, Jason Russel, Marcus Ryan, Mikey Taylor; step-brothers, Ron and Ryan Flanders, Justin Halbohm; and step-sister, Heather Stasulat; and many, many more cousins, uncles and aunts. He is also survived by the entire Irish clan of Smyth's from Galway , Ireland and the Peter's family, originally from the Azores in Portugal . The number of people who loved Jesse is very long, because Jesse was such a lovable guy. Jesse will also be missed by his many friends and classmates from Barrington , RI , and Piney Point , MD , at the Paul Hall Academy for Merchant Marines. Jesse, my dear son, you will suffer no more. Our lives were forever changed by your love and we will never be the same without you. Friends are invited to attend a Memorial Service on Tuesday, September 19, 2006 at 6:00 p.m. at SNEIDER & SULLIVAN & O'CONNELL'S FUNERAL HOME, 977 So. El Camino Real in San Mateo . In lieu of flowers, please send a donation to Jesse Lusian Anthrax Vaccine Victims Fund for Merchant Marines, c/o The Law Offices of Jeanne Levin, 2455 Bennett Valley Road, Suite C107 , Santa Rosa , CA 95404 .
Page Z - 99

September 12, 2006

Report: Ethics violators getting light punishment from NIH

Associated Press

The majority of federal scientists investigated for improperly accepting personal money from drug companies or biotechnology firms escaped serious punishment, and investigators declined to proceed with several cases involving possible crimes, according to the National Institutes of Health.

Only two of the ethics cases brought to light in the past two years inside the NIH remain open. In both cases, the scientists remain on the federal payroll.

Most of the rest got off with just written reprimands or verbal warnings for failing to get proper permission for their outside work or were allowed to retire, NIH spokesman John Burklow told The Associated Press.

The NIH's handling of the ethics cases has renewed questions inside Congress about whether the government's premiere medical research agency is serious about policing conflicts of interests among its scientists who take private sector money.

Of particular concern is the case of Dr. Trey Sunderland, a prominent Alzheimer's disease researcher who took hundreds of thousands of dollars in money from a drug company with which he also collaborated in his government capacity.

Sunderland continues to collect a federal check nearly a year after he was recommended for termination. He already had offered to resign two years ago to take a private sector job but the government wouldn't let him, according to correspondence obtained by AP.

"In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited," said Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee. "It's really, really disappointing."

One of Barton's subcommittees planned to hold a hearing Wednesday to press for more answers.

Burklow said Sunderland remains at NIH "because there is an open investigation."

Officials have told Congress that the Department of Health and Human Services' internal watchdog and the Justice Department both are investigating the scientist.

NIH investigated 103 employees after congressional hearings in 2004 and disclosures in the Los Angeles Times revealed many scientists weren't reporting their lucrative consulting deals with private companies as required. Forty-four employees were found to have violated ethics rules.

AP asked NIH to give an accounting of how those cases were resolved.

Burklow said two scientists got no punishment at all for infractions described as minor. Six left the agency before punishment could be meted out, and 10 were referred to the Health and Human Services inspector general for possible criminal investigation, he said.

The IG, the agency's internal watchdog, declined to pursue eight of those referrals, leaving them instead to face NIH administrative penalties such as suspensions ranging from a week to 45 days, Burklow said.

The rest, well over half, simply got written reprimands or verbal warnings.

Sunderland remains under investigation by the inspector general, who also is reviewing one other case. A government official, speaking only on condition of anonymity because the investigation is ongoing, identified the other researcher as Dr. Thomas Walsh, a prominent cancer scientist.

Sunderland and Walsh both committed "serious misconduct," so grave that they would be fired if they were civilians, according to reports written by NIH ethics officers.

Both are members of the Public Health Service Commissioned Corps, which provides medical help during disasters. So NIH sent its findings to that agency, which has yet to act on the NIH recommendations.

Both Sunderland and Walsh did private work for drug companies on government time, didn't seek approval or report their ties, and conducted research that overlapped their official duties in violation of federal law and regulation, the NIH ethics reports alleged.

Since the public revelations, NIH has banned outside consulting by agency scientists, a once widespread practice that allowed some researchers to eclipse their government salaries with corporate income.

Walsh, according to the NIH report, failed to report more than $100,000 in income from Merck & Co. and other drug companies between 1999 and 2004, and did not take leave time to do the consulting.

Reached at his NIH office on Monday, Walsh declined comment.

Sunderland ran afoul of the rules in earning more than $600,000 from the Pfizer Inc. drug company between 1996 and 2004 for consulting and lectures. NIH and congressional investigators also cited irregularities in his transfer of human tissue samples to Pfizer.

Lawyers for both scientists said they put in exceptionally long hours at their government jobs and that clerical problems were at least partly to blame for the lack of reporting.

Sunderland's lawyer said his client never intended to hide his dealings with Pfizer and that the government's failure to let him retire has cost him private sector opportunities and control of his Alzheimer's research.

"The bureaucratic inaction ... with respect to Dr. Sunderland's retirement request has unreasonably interfered not only with Dr. Sunderland's career but also with his important Alzheimer's research," Attorney Robert Muse wrote Congress on Monday.

Sunderland tried to retire two years ago and initially won approval in November 2004 from Dr. Thomas Insel, director of the National Institute for Mental Health, according to documents obtained by AP.

But less than six weeks later, NIH's deputy director Raynard Kington recommended that the Public Health Service Commissioned Corps deny Sunderland's departure, citing the ongoing investigation and potential "adverse effects" on the Corps' operations.

NIH recommended to the Corps in November 2005 that Sunderland be terminated, but he continues today on the government payroll.

Corps spokeswoman Christina Pearson said the agency has taken no action yet because there are "other reviews" it must coordinate with.

The Corps is concerned about the allegations surrounding Sunderland and Walsh, "and will take appropriate action should wrongdoing be found," she said.

Sunderland's problems could also impact the prestigious Journal of the American Medical Association, which requires authors to reveal any relevant financial affiliations at the end of their articles.

The scientist and an assistant did not disclose their Pfizer consulting agreements, in an April 23, 2003, article based on their Alzheimer's work with Pfizer.

Executive Deputy Editor Phil Fontanarosa said a correction explaining the Pfizer ties "most likely will be in order," once the government investigation concludes and JAMA editors review the outcome.