MBVP NEWS

Once again - Bioterrorism Acts are putting the citizens of this country at large in a dangerous situation. Note what the SAFETY Act Protections include.

News Release

http://www.prnewswire.co.uk/cgi/news/release?id=177829
U.S. Department of Homeland Security Certifies BioThrax(R) (Anthrax Vaccine Adsorbed) As An Approved Product For Homeland Security
GAITHERSBURG, Maryland, August 29 /PRNewswire/ --

- BioThrax(R) is the First Known Vaccine to Obtain SAFETY Act Protections
Emergent BioSolutions Inc., a privately held biopharmaceutical company, today announced that the United States Department of Homeland Security (DHS) has granted the company's application for designation and certification of BioThrax(R) (Anthrax Vaccine Adsorbed) as a "qualified anti-terrorism technology" under the "Support Anti-Terrorism by Fostering Effective Technology Act" (SAFETY Act).


BioThrax(R), the only FDA-approved vaccine for the prevention of anthrax infection, is the first known vaccine to be granted such SAFETY Act coverage. BioThrax(R) is manufactured by BioPort Corporation, a subsidiary of Emergent BioSolutions.

The Company submitted its SAFETY Act application to DHS pursuant to its 2005 contract with the Department of Health and Human Services (HHS) under which HHS purchased 5 million doses of BioThrax(R) for the Strategic National Stockpile (SNS). In May 2006, the Company executed a second contract with HHS for the delivery of an additional 5 million doses of BioThrax for the SNS.

The SAFETY Act, which Congress passed as part of the Homeland Security Act of 2002, is intended to encourage the development and deployment of anti-terrorism technologies by providing certain liability protections for providers of "qualified anti-terrorism technologies" (QATTs) for claims arising out of acts of terrorism.

To obtain SAFETY Act coverage, the applicant must submit to DHS comprehensive data and materials regarding the safety, efficacy, and deployment history of the technology. DHS then evaluates whether the technology meets the criteria for SAFETY Act coverage, including whether it is aimed at preventing, detecting, identifying, or deterring acts of terrorism, or limiting the harm that such acts might otherwise cause, and whether it performs as intended, is safe for use, and conforms to the manufacturer's specifications.

DHS granted BioThrax(R) both types of protections available under the SAFETY Act: "Designation" and "Certification." "Designation" provides the seller of a QATT with several benefits, including exclusive jurisdiction in federal court, limitation of liability to a specified amount of insurance coverage, and a bar on punitive damages. "Certification" confers status as an "Approved Product for Homeland Security" and enables the seller to invoke a rebuttable presumption that the government contractor defense applies, potentially eliminating liability for claims arising from acts of terrorism.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to protecting life through the development, manufacture, and commercialization of immunobiotics, which are pharmaceutical products that induce the immune system to prevent or treat disease. These include products for prophylactic and therapeutic use against infectious diseases with significant unmet or underserved medical needs and against biological agents that are potential weapons of bioterrorism. The Company currently employs more than 450 people with sites in Maryland, Michigan, the United Kingdom, Germany, and the Republic of Singapore. More information about Emergent BioSolutions is available at http://www.emergentbiosolutions.com .
Web site: http://www.emergentbiosolutions.com

Distributed by PR Newswire on behalf of Emergent BioSolutions Inc.

Posted by MBVIC at 8:01 AM | Permalink

Ex-HHS Chief Thompson Now Peddling Spychips
By Martin H. Bosworth
ConsumerAffairs.Com

If microchip maker VeriChip has its way, the armed forces will soon be trading in their dogtags for radio-frequency identifier (RFID) microchips, implanted under the skin and containing all of their medical and personal information.


The company is lobbying the Pentagon for the authority to implant RFID tags in virtually all military personnel, according to a series of articles in The Examiner, a Washington, D.C., newspaper.

VeriChip's plans are meeting opposition from veterans' groups, members of Congress, and privacy advocates, all of whom are concerned about the technology and its potential security risks.

Leading the company's charge is former Health and Human Services Secretary Tommy Thompson, now a lobbyist. Thompson, who sits on VeriChip's board of directors, insists that the chip is safe and that no one will be forced to have the procedure.

Thompson has boasted repeatedly that he plans to have a chip inserted in himself to demonstrate its safety. He hasn't yet done so, however.

Although Thompson and VeriChip have repeatedly claimed that RFID technology is safe and secure against potential hackers and data thieves, a recent investigation by Wired magazine editor Annalee Newitz proved otherwise.

Newitz, who has a chip embedded in her arm, demonstrated that RFID chips can be "read" by other devices at a hackers' conference in New York on July 22nd.

Newitz and colleague Jonathan Westhues showed how a laptop could be used to record the data off her RFID chip, and that a standard RFID reader would read the data off the laptop as if it were one and the same. "{The RFID chip} actually has no security devices whatsoever," Newitz said.

VeriChip contested Newitz's findings, saying it wished to review the data itself.

With Thompson calling in political favors and cashing in on his years on the public payroll, the Department of Defense isn't the only arm of the government interested in VeriChip's RFID push.

The Department of Homeland Security issued a request for information on how to find or create stronger RFID readers that could actively sense chips implanted in passports and other traveler information.

The Homeland Security request was uncovered by privacy advocates Katherine Albrecht and Liz McIntyre, founders of anti-loyalty card organization CASPIAN and largely credited with bringing the issue of RFID chips to the mainstream.

McIntyre and Albrecht also uncovered a covert move by the Levi Strauss company to quietly test jeans implanted with spychips in the United States. The resulting public furor forced the company to back off from its plans.

Albrecht and McIntyre have repeatedly challenged the usage of RFID tagging for consumer products, claiming that it gives corporations the ability to track shoppers' buying patterns and build information profiles of them.

They have also criticized the government for embracing the usage of RFID technology without proper oversight or privacy protections.

Several members of Congress voiced similar concerns over VeriChip's potential deal with the Pentagon. Senator Patrick Leahy (D-VT) told The Examiner that, "There are many questions that need answers" before the initative can be approved.

Rep. Tom Davis (R-VA), chair of the House Government Reform Committee, told his staff to investigate VeriChip's proposal and examine it for any potential concerns about privacy.

VeriChip, with an initial public offering for its stock pending, is aggressively pushing as many new markets for its technology as possible. VeriChip chairman Scott Silverman ruffled feathers when he publicly suggested undocumented laborers could be implanted with RFID chips as part of President Bush's "guest worker" proposals.

Wisconsin governor Jim Doyle recently signed into law a statewide ban on implanting microchips of any sort into humans. The law, introduced by state assemblyman Marlin Schneider and passed unanimously, levies a fine of $10,000 per day on anyone who forces an individual to be implanted without their permission.

Ironically, Verichip peddler Tommy Thompson was governor of Wisconsin before his tenure as a one-term Secretary of Health and Human Services.

Posted by MBVIC at 11:24 AM | Permalink

Byron J. Richards

The FDA is now poised to dramatically change the health and well being of all Americans. Unfortunately, they are headed in the wrong direction--straight over a cliff. The FDA is supposed to make sure drugs are safe and effective; they are mandated to protect the public. However, the top two positions at the FDA are now headed by Big Pharma representatives. The Bush-appointed new FDA leadership is intent on removing any brakes being applied to the drug approval process, quite happy to turn ill Americans into human guinea pigs.


Piloting this sinking ship is Andrew von Eschenbach, M.D., a Bush family friend. Since last October, he has been the temporary head of the FDA. We are now in the midst of his Senate confirmation process to be the permanent head of the FDA (a vote is expected mid September). Von Eschenbach is up to his eyeballs in Big Pharma and elite political connections, making his confirmation likely. Once the Plan B political hurdle is overcome, von Eschenbach plans to transform the FDA into a drug company. To avoid consumer confusion the FDA should change its name to something more fitting, like the Fast Drug Approval organization.

Flanking von Eschenbach is the thirty-three-year-old Scott Gottlieb, M.D. Gottlieb has no experience in drug safety and little clinical experience as a physician. Rather, he is an expert at promoting biotech stocks on Wall Street. He has numerous financial connections with drug companies. Standing in the way of Wall Street profiteering is a small group of scientists hiding in a back room at the FDA. Not surprisingly, prior to joining the FDA Gottlieb spent considerable energy lambasting the agency for not approving drugs fast enough.

Several years ago, as a member of the neo-con think tank known as the American Enterprise Institute, Gottlieb was invited into the FDA to rewrite its policy! Talk about a Trojan horse. Now that Gottlieb is second in command at the FDA, he has made it clear he doesn't want the public to know when there are problems with drugs. While the FDA continues to aggressively harass safe and effective nutritional supplements, warning letters to drug companies have dramatically declined. The FDA agenda is favorable to Big Pharma and the sickness industry. It is harmful to the personal health and health options of Americans. Gottlieb represents energized youth willing to implement the von Eschenbach plan to strengthen the sickness industry monopoly for the next fifty years.

At von Eschenbach's recent Senate confirmation hearing he was quick to point out that Scott Gottlieb would be instrumental in implementing the new FDA plan, referring to him and a few other FDA executives as "my greatest asset in leading the FDA." Frankly, that is an incredibly scary thought.

Not everything is running smooth as glass. Gottlieb was recently and very publicly embarrassed for the FDA's lax approach to safety. Von Eschenbach's going away party from the National Cancer Institute (he was heading both the FDA and NCI) had to be canceled, because the invitations asked for gifts--a violation of federal law. And, when the FDA was given its own health checkup after nine months of von Eschenbach leadership, it was found to be suffering from ED (Ethical Disease), perverting science for political and financial benefactors.

President Bush has learned that the best way to bring rapid change to the FDA is to appoint to its top positions harsh critics and former adversaries of the agency. The FDA purpose to provide consumer safety is being stamped out of existence.

What goes on in Washington represents the ultimate political game; positioning power, money, and issues for the benefit of the elite ruling class. Seldom does the American public understand what is going on. The morning after pill is obviously a hot potato. Politicians do not consider the abortion issue too hot to handle, they simply use it as a smoke screen to cover up the real issues at hand.

For example, Bush knows all too well that stem cell research will move forward with or without his blessings. Thus, with his ratings so low, his veto several weeks ago was nothing more than a political attempt to placate part of his fan base. Now he finds his FDA appointee on the abortion hot seat. Is Bush wielding his influence to scuttle Plan B? Of course not, the White House is silent. It is far more important to Bush that his drug-peddling friend gets into permanent power than it is to do something meaningful for what he pretends to believe in.

Hillary Clinton, as sly a politician who has ever existed, is more than happy to hold Bush's feet to the hot coals. Hillary to George, "Give me Plan B and I'll let you have von Eschenbach." George to his fan base, "There was nothing I could do about it. The FDA is an independent government agency."

Both Hillary and George want von Eschenbach approved, he is an ideal FDA chief for both of their warped healthcare agendas. The ones suffering in this game are Americans and their health. The suffering is not trivial; we are talking about broken lives and dead patients in the hundreds of thousands.

The Plan B decoy is a diversion so that no real questions are asked of von Eschenbach. How many Americans actually know anything about Andrew von Eschenbach? Serious Questions Surround Andrew von Eschenbach

It is quite clear that Andrew von Eschenbach has put in his time as an oncologist, researcher, and administrator involved with the cancer issue. Any person taking the time to look past the glowing résumé quickly finds out that he is well connected to Big Pharma and his emphasis is on using drugs to manage disease, a highly profitable approach to health care for Big Pharma. In fact, this approach has very little to do with positive health outcomes for patients.

Any reasonable person examining the von Eschenbach track record would never allow him in the front door of the FDA. As a major advocate of Big Pharma, he is the exact type of person that the FDA must monitor and regulate so as to protect the American public. Having him as the head of the FDA is a gigantic conflict of interest.

He was born October 30, 1941, apparently in Philadelphia, PA. Obviously of German heritage, this places his birthday at the height of World War II. Who was his father? What was his occupation? What were his connections to Germany? All we seem to know about his father is that he died of prostate cancer. These are fair questions, since the FDA is currently colluding with the German government behind the backs of Congress and the American people, crafting Codex rules to eliminate effective nutritional supplements and health options from the market (read "Fight for Your Health: Exposing the FDA's Betrayal of America"). What are von Eschenbach's current connections to Germany, the German government, and German drug and biotech companies? Why is the FDA operating in secrecy with foreign governments, including Canada and Mexico? What is going on?

Von Eschenbach had a long career at the MD Anderson Cancer Center. During his tenure he rose up the administrative ranks, eventually in charge of the operation. And this is where the serious problems began. He was involved in starting a nonprofit organization called the National Dialogue on Cancer (which has since adopted the name C-Change).

This is not an innocent group of cancer advocates. It is the Bilderbergs of American health. Meeting in secret, this elite organization plans and plots how to use the health resources of our federal government to forward the agenda of Big Pharma, especially relating to cancer care. They operate outside the scrutiny of Congress, yet are interwoven into the fabric of our federal government. Instead of approving von Eschenbach, Congress should be investigating this national health fiasco and diversion of public funds to private interests. There is a reason our government has spent billions of dollars on cancer research and nothing much has happened. Where did all the money go?

The major elite leaders of C-Change are the parents of our current president, George Sr. and Barbara Bush. They are the ones who invite members to participate in their elite clique. Of course, we must not forget that the Bush family wealth was created by the president's grandfather, Prescott Bush, who made his fortune financing the build up of the Nazi war machine before Congress shut him down. George Bush Sr. has sat on the board of Ely Lilly. You get the picture. C-Change is an old boy network of elite Big Pharma and related interests (including big tobacco!).

Diane Feinstein (D CA) serves as vice-chair of C-Change. At the same time she promotes Big Pharma, she actively seeks to eliminate nutritional supplements from the market. She is one of the most anti-health-freedom members of Congress. How is it legal for government officials to collude with private industry outside the view of the American public and Congress? And remember, von Eschenbach is right smack in the middle of this scam.

C-Change is intimately connected with big tobacco. They have hired various PR firms that work for big tobacco. While these firms have been engaged in helping tobacco, they are at the same time helping to write policy that is intended to influence how our federal government spends money treating cancer. The shady history and connections of C-Change and the tobacco industry have been documented by the Cancer Letter.

Von Eschenbach has been a major player in C-Change since its inception. Parlaying his political connections, in January of 2002 our current president appointed him the head of the National Cancer Institute (NCI). All of a sudden, the fox was in charge of the henhouse. Even worse, he actually had a waiver signed by Tommy Thompson, the head of Health and Human Services, allowing him to remain on in capacity at C-Change while he headed the NCI! The waiver specifically spells out and acknowledges that a drastic conflict of interest already exists, "Furthermore, the NIH and NCI interests in the Dialogue [C-Change] are considerable, both from the scientific and financial standpoint. NCI has already engaged with many of the Members [of C-Change] in grant, contract, or collaborative efforts….Finally, the agency already has determined through support of the Dialogue's Members [C-Change], that, to a significant degree, the interests of the Department and the interests of the Dialogue [C-Change] both can be furthered through the performance of Dr. von Eschenbach's official duties."

During his tenure at NCI, while remaining as vice-chairman of C-Change, he undermined basic scientific research on cancer, instead directing funds to his pet projects for new biotech drug research. He created the unrealistic expectation that cancer would be cured by 2015, devoting billions of dollars to pie-in-the-sky genetic research that will have little benefit for many decades. Of course, these research dollars went to his C-Change friends. His conflicts of interest are so obvious and extensive that everyone is becoming numb to them. Interviews with NCI scientists show that the agency has been technically crippled under von Eschenbach leadership. No effort is spent to clean up the poisons in the environment that are the cause of cancer for so many Americans. After all, that would cause a decline in the cancer business and reduce the profits of the sickness industry.

While von Eschenbach was busy corrupting the NCI for the profits of the elite, in October of 2005 President Bush also placed him at the top position in the FDA! Apparently, both were part time jobs. Sure enough, von Eschenbach announced that the top priority of the FDA is speeding new drugs to the market, and eliminating safety studies that prove effectiveness, in favor of new genetic technology. The goals of Andrew von Eschenbach have never changed, only his job titles. He is entirely predictable. Is this what Americans want running a safety agency?

The bottom line is that very soon the FDA will base effectiveness of drugs on protein signals inside cells evaluated in a lab by a supercomputer. Effectiveness will no longer be based on such obvious outcomes as living longer or improved quality of health, based on controlled studies. Be defining safety and effectiveness on gene signal manipulation, the FDA will have a far lower standard for safety and effectiveness, enabling massive numbers of dangerous and toxic drugs to enter the market for human experimentation. Surely, this has C-Change members jumping up and down for joy, the echo being heard up and down Wall Street--and soon to be heard across the morgues in our country.

In order to carry out the von Eschenbach health vision of America your DNA will need to be in an FDA owned database. The FDA would also like radio frequency chips in your arm that contain your medical information (as well as your location). Do you trust them?

It is likely that men and women of our Congress will rubber stamp the von Eschenbach approval. I think we should all pay attention to exactly who votes to confirm Andrew von Eschenbach. And I think they should stand trial when the FDA-condoned death toll, already in the hundreds of thousands per year, sharply increases. It is not too late for Americans to call their Senators and tell them, "Vote no on von Eschenbach, we need an FDA chief who puts safety first."

Americans are being plunged into a high tech Dark Ages of healthcare. The Big Pharma juggernaut is on a rampage. The American population is asleep at the wheel, forfeiting their own health and the health of their children and grandchildren. All the while pretending they are doing something meaningful by having a war over abortion and right to life issues.

Thus, I write this article as a commentary on American history. Looking back in ten, twenty, or fifty years there will be a new congressional inquiry. This one will be centered on the massive numbers of deaths of Americans at the hands of Big Pharma and the FDA. It will make the Vioxx scandal look like a Sunday afternoon picnic. The congressional leaders, under pressure from millions of adversely affected patients and families of the injured, will be forced to examine the sordid monopoly of healthcare in America.

The FDA will be painted as the corrupt agency it has always been. The appointment of Andrew von Eschenbach will stand out as the seminal turning point, the progression to stage four cancer of the American health system. And the leaders of tomorrow will scratch their heads wondering about the leaders of today. Rules and laws will be crafted to placate the angry public, apparently to prevent such dangers from ever happening again. These rules will be twisted and avoided (for a small fee) by those they seek to regulate. And the politicians will look in the mirror, look in their wallets, and realize nothing has changed.

Byron J. Richards, Founder/Director of Wellness Resources, is a board-certified clinical nutritionist and nationally renowned health expert, radio personality, educator and author. His book, "Fight for Your Health: Exposing the FDA's Betrayal of America," is one of Mike Adams' must-read books for 2006. Article reprinted with permission of Truth in Wellness, LLC, copyright 2006.

Posted by MBVIC at 8:37 AM | Permalink

Imperial College London, UK
Anthony Stephenson

New research from scientists at Imperial College London explains why some vaccines can have unexpected side effects, a finding that could aid the development of safer and more effective vaccines in the future.


The study published this month in Nature Medicine, shows how formalin, used in the manufacture of over half of all vaccines, can alter the vaccine's effect on the immune system.

The Wellcome Trust and Medical Research Council funded research shows that formalin causes chemical damage to vaccine proteins and creates reactive chemical groups called carbonyls. The immune system reacts strongly when it spots this damage.

In many cases, deliberately adding carbonyls to a vaccine can improve the body's immune response, such as with hepatitis A vaccines. However, in others, the presence of carbonyls can mean that the immune system overreacts once infection occurs and attacks the body in a damaging way.

In the 1960s, carbonyls in experimental vaccines for a virus known as RSV, which causes wheezy colds in children, triggered a powerful immune response that caused severe side effects leading to hospitalisation and several deaths.

Professor Peter Openshaw , from Imperial College London, who led the research, said: "Although we have known for sometime that certain vaccines can prove ineffective or in extreme cases, cause a bad reaction, we have not really known the exact mechanism behind this until now. This study gives us a new level of understanding about how vaccines boost the immune system."

The studies suggest that avoiding formalin in the manufacture of vaccines may in some cases reduce the frequency of side effects. It also shows that it it is possible to reverse the effects of formalin by additional chemical treatment. The team have taken out a patent which will allow them to further study and develop the use of carbonyls for vaccine development.

A potential molecular mechanism for hypersensitivity caused by formalin-inactivated
vaccines
(http://rs6.net/tn.jsp?t=e6dr4xbab.0.ydrr4xbab.oblmlwbab.4352&ts=S0202&p=http%3A%2F%2Fwww.nature.com%2Fnm%2Fjournal%2Fv12%2Fn8%2Fabs%2Fnm1456.html)

Nature Medicine - 12, 905 - 907 (2006)

Published online: 23 July 2006; | doi:10.1038/nm1456

Authors: Amin Moghaddam, Wieslawa Olszewska,
Belinda Wang, John S. Tregoning, Rebecca Helson,
Quentin J. Sattentau & Peter J. M. Openshaw

Correspondence should be addressed to Peter J.
M. Openshaw: p.openshaw@imperial.ac.uk

Heat, oxidation and exposure to aldehydes create reactive carbonyl groups on
proteins, targeting antigens to scavenger receptors.

Formaldehyde is widely used in making vaccines, but has been associated with atypical enhanced disease during subsequent infection with paramyxoviruses.

We show that carbonyl groups on formaldehyde-treated vaccine antigens boost T helper type 2 (TH2) responses and enhance respiratory syncytial virus (RSV) disease in mice, an effect partially reversible by chemical reduction of carbonyl groups.

Click
here for the URL:
(http://rs6.net/tn.jsp?t=e6dr4xbab.0.xdrr4xbab.oblmlwbab.4352&ts=S0202&p=http%3A%2F%2Fwww.imperial.ac.uk%2FP8063.htm)

Posted by MBVIC at 6:00 PM | Permalink

By Jeremy W. Steele
Lansing State Journal

The parent company of anthrax vaccine maker BioPort Corp. might go public in an effort to raise cash for its $75 million Lansing expansion and clinical trials of new products.


Gaithersburg, Md.-based Emergent BioSolutions Inc. has filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of common stock.

"This is simply the first step for the process," Emergent spokesman Robert Burrows said.

Such an offering, if approved by the SEC, could bring in more than $86 million, Emergent said in its regulatory filings.

That would cover two years of Emergent's operations and capital expenditures, including the new 50,000-square-foot vaccine production facility being built on BioPort's campus, filings said. Emergent plans to have the plant operational by 2008.

The number of shares to be offered and the price range have not been determined, the company said. However, it has applied to list its stock under the ticker symbol "EBSI" on the Nasdaq stock market.

Emergent was formed in 2004 as the parent of BioPort, which was created in 1998 from the purchase of the anthrax vaccine lab from the state of Michigan. It employs more than 300 in Lansing.

Fuad El-Hibri, Emergent's president, chief executive officer and chairman, now owns more than 99 percent of the company's outstanding common stock.

The company largely has grown through the acquisition of other vaccine makers and has been profitable for the past three years.

It made $15.8 million on revenue of $130.7 million in 2005. Emergent made an $11.5 million profit in 2004 and $4.5 million profit in 2003.

However, Emergent cautioned in SEC filings that it remains reliant on its one product line for sales - the anthrax vaccine. And 99 percent of those sales are to U.S. government sources.

Several other companies are nipping at Emergent's heals with new anthrax products.

Vaccine maker VaxGen Inc. was awarded an $877 million U.S. Department of Health and Human Services contract in 2004 for the anthrax vaccine it's working on.

California's VaxGen has yet to ship any product.

In June, HHS bought 20,000 doses of an anthrax treatment from Maryland's Human Genome Sciences Inc. for about $165 million.

Emergent has vaccines for typhoid, Hepatitis B and streptococcus in clinical trials.

Vaccines for botulinum toxin, chlamydia and meningitis B also are in the works.

Whether those vaccines will get U.S. Food and Drug Administration, however, is another unknown for Emergent. Contact Jeremy W. Steele at 377-1015 or jwsteele@lsj.com.

Posted by MBVIC at 1:19 PM | Permalink

http://www.opednews.com/articles/genera_evelyn_p_060821_lawmakers_say_fda_be.htm
by Evelyn Pringle
http://www.opednews.com

For six years, the Bush administration has placed pharmaceutical industry interests ahead of public interest by appointing persons with strong ties to drug companies to high level positions at the FDA, and as a result, Congressional investigations and a recent survey indicate that the health and safety of all Americans is being compromised.


On July 20, 2006, the Union of Concerned Scientists published the results of a survey that showed an insidious political influence of science within the FDA. According to the UCS press release, the survey was co-sponsored by Public Employees for Environmental Responsibility (PEER), and was sent to 5,918 FDA scientists.

The survey found that 61% of the responding scientists knew of cases where the "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

In responding to the survey, one scientist wrote: "Over the last several years I have noticed a significant increase in the number of decisions that have become politicized (e.g., increasing requests to review even simple regulations and changes, both by Congress and the Commissioner's office and to make apparently politically-motivated changes in language and sometimes to alter bottom line results), and I think the integrity of scientific work could be improved by minimising the 'politics' of the process."

Out of the nearly 1000 scientists who responded, close to one-fifth or 18.4%, said they had "been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

In addition, 40% of the scientists said they fear retaliation for voicing safety concerns in public and more than one-third said they did not feel they can express safety concerns even inside the agency.

The survey also found that only 47% think the "FDA routinely provides complete and accurate information to the public," and 81% agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

In a complaint aimed at the FDA's Office of Regulatory Affairs, one scientist said it should "not ostracise scientists or black ball them because their foresight sees a problem with a drug, device, food, biologics, etc. that possess a potential hazard to health now or in the future."

In response to the concerns raised by FDA scientists, the UCS recommends:

– Accountability: FDA leadership must face consequences if they side with commercial or political interests and not with the American people.

– Transparency: Scientific research and reviews should be open so any undue manipulation is immediately apparent.

– Protection: Safeguards must be put in place for all government scientists who speak out.

"These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Dr Francesca Grifo, Senior Scientist and Director of UCS's Scientific Integrity Program, in the press release.

"All federal scientists," he said, "need protections so they can speak out when their science is manipulated, and all federal agencies need fully functioning independent advisory committees."

"FDA leaders," Dr Grifo noted, "should act now to improve transparency and accountability and renew respect for independent science at the agency."

"FDA leadership," he stated, "must understand and support independent science and it is up to Congress to hold them accountable."

But nothing about this survey is news to FDA officials. By use of the FOIA, the UCS and PEER, recently obtained a copy of a previously unpublished survey by the Health and Human Services Office of Inspector General from late 2002, that polled 846 FDA scientists, and with nearly half responding determined that:

Nearly one in five said that they "have been pressured to approve or recommend approval" for a drug "despite reservations about the safety, efficacy or quality of the drug"

Two-thirds lacked confidence that the FDA "adequately monitors the safety of prescription drugs once they are on the market"

Only 12% of the responding scientists were completely confident that FDA "labeling decisions adequately address key safety concerns," and 30% were not at all or only somewhat confident

More than one-third were not at all or only somewhat confident that "final decisions adequately assess the safety of a drug"

Despite the above results, the report published by the OIG in March 2003, included the conclusion that FDA scientific reviewers "have high confidence in decisions FDA makes."

On August 8, 2006, the UCS briefed acting FDA Commissioner, Andrew von Eschenbach, on the latest survey and discussed the political inference at the FDA. To restore integrity, UCS recommended that Dr von Eschenbach adopt and enforce three basic commitments:

(1) to ensure that data or results are never softened for any audience. Rigorous scientific debate must be valued at the FDA;

(2) to pledge to support scientists who speak out by taking adverse employment action against any manager who retaliates against a reviewer; and

(3) to commit to a culture that supports a collaborative process of testing and challenging scientific hypotheses.

Along with the recommendations, the group's August 8, 2006, press release said, "The FDA must allow an open scientific process and recognize the need for scientists to pose and answer questions without consequences related to their status at the FDA."

Critics claim that a major issue that needs to be addressed involves the rampant conflicts of interest among members of the FDA's advisory panels who have financial ties to the pharmaceutical industry. In November 2005, a new law was passed that required members of the committees to disclose all financial ties to drug companies.

The categories for disclosure were broken down into dollar amounts and time frames, such as less than $10,000 a year or between $10,000 and $50,000 a year. After reviewing the financial disclosure forms, the FDA is permitted to grant waivers that allow experts to sit on panels even if they have financial ties to a drug company.

However, on April 21, 2006, the Boston Globe discussed the practical effects of the law since it was enacted and reported that FDA critics "say the new transparency has changed little, and scientists who have conflicts of interest can still guide FDA decision making."

In less than 6 months after the law went into effect, the Globe determined the FDA had granted close to 100 waivers.

One of the current investigations of the FDA involves allegations that the agency approved the antibiotic, Ketek, despite serious questions about the drug's safety and efficacy, and with full knowledge that the clinical study submitted to support Ketek's approval was fraudulent.

Critics say Ketek's side effects of liver damage were known to its maker, Sanofi-Aventis, early in clinical trials but were covered up. The drug has been blamed for the death of four patients and the liver damage or failure in 37 other patients since 2004.

Internal FDA emails that surfaced during the investigation show that at least four FDA safety officials, Dr David Graham, Dr Charles Cooper, Dr David Ross and Dr Rosemary Johann-Liang, had voiced serious concerns about the safety of the drug.

"I tried to argue that given Aventis's track record in which they have proven themselves to be nontrustworthy that we have to consider the possibility that they are intentionally doing a poor job of collecting the postmarketing data to protect their drug sales," Dr Cooper said in an email.

"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Dr David Graham wrote in an email that recommended Ketek's "immediate withdrawal."

"We don't really know if the drug works;" he said, "no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs."

In May 2006, Dr Johann-Liang called for a halt to tests of Ketek in children with ear infections, arguing that cutting the duration of ear pain by one day was hardly worth risking death.

The FDA's actions in regard to Ketek are being investigated by Senator Charles Grassley's (R-Iowa), Senate Finance Committee, and by Representatives, Edward Markey of Massachusetts, and Henry Waxman of California, ranking Democrats on the House Government Reform Committee.

In May 2006, the lawmakers released a statement that said although "the FDA has consistently assured the public of Ketek's safety and efficacy, public documents obtained and examined by Representatives Markey and Waxman's staff indicate that the approval process for this drug was seriously flawed."

As Chairman of the Senate Committee, Senate Grassley has called for a "major overhaul and a culture change at the highest levels" of the FDA. In a May 1, 2006, press release, he noted concerns over the FDA's complicity with the drug maker and its subsequent failure to ensure the integrity of a study on the benefits and risks of Ketek.

The Senator called it "mystifying" on May 16, 2006, that the FDA would continued to provide information that it knew was fraudulent, and warned that he planned to keep the pressure on the FDA to provide more information about Ketek's approval and post-market surveillance.

According to Dr Graham, Ketek is at least as toxic to the liver as three other drugs that have been pulled off the market and the FDA's original approval of the drug was based on a study that FDA officials knew was fraudulent.

"It's no surprise to learn that the FDA didn't listen to Dr. Graham on the dangers of Ketek," Senator Grassley was quick to point out. "The FDA has made it their business to discredit Dr. Graham and others who aren't willing to cater to the drug companies," he noted.

In October 2001, doctors began enrolling subjects for the Ketek clinical trial known as Study 3014, and were paid $100 for each patient that signed up. The participating doctors would also receive another $150 when the study results were submitted, and a final $150 when all questions related to the study were resolved, according to the May 1, 2006, Wall Street Journal.

On July 24, 2002, drug maker Aventis submitted the results of the study to the FDA, but when FDA officials submitted the study to the advisory committee for review, they did not disclose that the Division of Scientific Investigation and Office of Criminal Investigation was investigating the integrity of the study.

The misconduct that took place during the clinical trials is so serious that critics say it calls the validity of the entire study into question. For instance, the doctor who signed up the 3rd highest number of patients, was in a chronic state of cocaine addiction while conducting the clinical trial, and was arrested and found to have cocaine hidden in his underwear, while holding his wife hostage with a gun, the same month the study results were submitted to the FDA.

Another doctor who participated in the study was totally disqualified as an investigator and prohibited from conducting any clinical trials in the future, and another who signed up 150 patients was cited for 20 violations of the study's instructions.

Dr Anne Campbell, the doctor with the highest number of subjects in the study, was sentenced to nearly 5 years in prison in March 2004, after being charged in a 21-count indictment over her misconduct.

Senator Grassley is demanding a face-to-face interview with the FDA investigator who discovered the fraud and misconduct in the trials, who he contends "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty."

This investigator authored a March 25, 2004, memorandum from the Division of Scientific Investigations titled, "DSI Recommendations on Data Integrity," that states in part, that Study 3014 involved "multiple instances of fraud" and that "the integrity of data from all sites involved in [the] study ... cannot be assured with any degree of confidence."

After months of trying unsuccessfully to get an interview, Senator Grassley finally marched right over to the Department of Health and Human Services headquarters and asserted a congressional right to speak to the investigator.

After a brief conversation with senior officials, he left mad as a hornet. "This is extraordinary to me," he said outside HHS headquarters. "I haven't had to go to an agency like this since 1983 to get information I requested.

"I smell a cover-up," he stated.

On June 22, 2006, Senator Grassley publicly announced a not too subtle warning to officials at the agency. "Two years ago I called a congressional hearing to probe the FDA's handling of the withdrawn painkiller Vioxx," he said in a statement.

"It might be time," he warned, "to round up another oversight hearing after the runaround I got recently at the FDA."

"The FDA," he wrote, "refused to allow me to question an internal investigator who is leading an inquiry into alleged fraud involved with clinical trials for the antibiotic Ketek."

"So for only the second time in 23 years," he said, "I resurrected in June my unconventional means to fulfill my Constitutional oversight responsibilities."

He said, "I appeared at the FDA's doorstep," and noted that agency officials refused to let the investigator speak to him.

However, he warned, "Bureaucratic stonewalling won't deter this U.S. Senator."

"I won't rest," Senator Grassley said, "until the light of day exposes what ought to be available for public consumption."

"It all boils down to keeping the government accountable," he wrote, "to the people and strengthening the public trust in government."

In another statement released on June 29, 2006, he stated, "Ketek is another example where the F.D.A. accommodated a drug maker and turned a blind eye to serious safety concerns."

Over the past couple of years, the suppression of the scientific process and the muzzling of scientific dissent at the FDA became evident first when officials forced Dr Andrew Mosholder to suppress a link he found between SSRI antidepressants and suicide in children, and Dr Graham went public with allegations about the FDA's mishandling of the Vioxx matter.

On March 10, 2005, Senator Grassley gave a speech to the Consumer Federation of America and said these two whistleblowers had done more to shake up a complacent FDA than probably anybody in recent history and relayed parts of the story saying:

"Early last year I heard that the FDA was muzzling one of its own scientists. In February 2004 the FDA held a meeting to decide whether there was a link between some antidepressant drugs and suicidal behavior in kids.

"Dr. Andrew Mosholder – the FDA's expert in this area -- concluded there was a link. However, FDA management disagreed. So, when Dr. Mosholder stuck by his findings, his supervisors canceled his presentation to an advisory committee.

"Instead of allowing Dr. Mosholder to present his findings publicly and subject them to committee scrutiny, the scientific process and his peers, the FDA effectively muzzled him."

But despite the FDA's best efforts, Senator Grassley said, Dr Mosholder wouldn't be silenced and months later he was proven right.

Citing information from the Department of Justice, he told the audience that there are currently under seal in the neighborhood of 100 whistleblower cases involving allegations against over 200 drug companies.

"During the past four years," he stated, "the department recovered nearly 2 and a half billion dollars from whistleblower cases against drug companies."

Senator Grassley called Dr Mosholder and Dr Graham great patriots. "Think about the guts it takes to undermine your career, and to go against your supervisors at a huge federal agency," he said, "and in this case, the multi-billion-dollar drug companies."

In an August 30, 2005, interview with Manette Loudon, the lead investigator for Dr Gary Null, Dr Graham discussed how FDA officials attempted to suppress the results of his study on Vioxx a year earlier. According to Dr Graham, prior to his Senate testimony in mid-November of 2004, there was an orchestrated campaign by senior FDA managers to intimidate him so that he would not testify about the adverse affects of Vioxx to Congress.

One attack he says, came when the acting FDA Commissioner, Lester Crawford, contacted the editor of the Lancet, a UK medical journal, and told him that Dr Graham had committed scientific misconduct and that the journal should not publish the paper that he had written showing that Vioxx increased the risks of heart attack.

The second attack came from other high level officials, he said, who contacted Senator Grassley's office in attempt to prevent Senator Grassley from calling him as a witness.

And the third he says came from senior FDA officials who contacted Tom Devine, Dr Graham's attorney at the Government Accountability Project, and attempted to convince him that the GAP should not represent Dr Graham because he was guilty of scientific misconduct.

According to Dr Graham, these officials posed as whistleblowers themselves, and told Mr Devine that Dr Graham was a "bully," a "demigod," and a "terrible person" that could not be trusted.

In one more last ditch effort to thwart Dr Graham's testimony the week before he testified, he says, the acting Commissioner offered him a job in the Commissioner's Office to oversee the revitalization of drug safety if he would just leave the Office of Drug Safety.

"Obviously he had been tipped off," Dr Graham said in the interview, "by people in the Senate Finance Committee who are sympathetic to the FDA's status quo that I was going to be called as a witness."

To preempt his testimony, he told Ms Loudon, he was offered a job "which basically would have been exile to a fancy title with no real ability to have an impact."

According to Dr Graham, by allowing Vioxx to stay on the market, the FDA is responsible for 140,000 heart attacks and 60,000 dead Americans. "That's as many people as were killed in the Vietnam War," he points out.

He says the FDA could have prevented many of the heart attacks and deaths simply by banning the high dose Vioxx back in 2000 when the agency learned about the results of the VIGOR Study. "But the FDA did nothing for almost two years," he states. "They were "negotiating" with the company over a label."

"The FDA made bad decisions," Dr Graham said, "based of its culture and its institutionalized biases that favor industry, and as a result thousands of Americans died."

During a July 18, 2005, speech on the Senate floor, Senator Grassley proclaimed, "this country's confidence in the FDA has been shaken."

It has not been shaken, he said, by one isolated incident or whistleblower. "It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower."

"Dr. Graham's testimony before the Finance Committee," he told members of Congress, "suggests that the problems are systemic."

"Oversight of the FDA," Senator Grassley advised, "exposed the cozy relationship that exists between the FDA and the drug industry."

"It revealed that the FDA negotiated for almost two years with Merck," he said, "about how to change the Vioxx label so people would know about the risk of heart attacks."

According to Dr Graham, the Vioxx disaster would not have been as severe in the absence of direct-to-consumer advertising. "I submit," he told Ms Loudon, "that the numbers would have been far lower than what they were."

Due to heavy marketing of new drugs, Dr Graham says, lots of patients and doctors will use a new drug that is no better than another drug already on the market, even though the FDA does not require that new drugs be at least equivalent to, or better than, the drugs that are already there. All the drug maker has to prove is that a drug works better than a sugar pill, he says.

Silencing scientists to protect the industry has become habitual under the current politically appointed rulers of the FDA. According to Shane Ellison, author of "Health Myths Exposed," pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports.

"Science and choice," he warns, "no longer prevail at the FDA or at pharmaceutical companies."

Mr Ellison is a former pharmaceutical industry chemist who says he felt a responsibility to reveal the truth about the industry's sordid tactics after he witnessed first-hand how they deceive the public, according to a September 3, 2005, interview with Crusador Editor, Greg Ciola.

"To go against the 51% means losing your career," Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."

As an example, Mr Ellison discussed Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg, he says, came forward to reveal that Bextra also caused heart attack and stroke. In the British Medical Journal, Dr Furberg said that his studies showed Bextra to be no different than Vioxx, and warned that Pfizer was trying to suppress that information.

"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that is responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."

"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes – not science," Mr Ellison told Crusador.

In the case of the pain relieving Cox-2 inhibitors, the FDA's advisory committee was stacked with experts with ties to the drug makers. Of the 32 advisers who would vote on the drugs, it has since become known that 10 of panel members had consulted in recent years for Vioxx maker, Merck, or Pfizer who made Celebrex and Bextra.

While the committee voted unanimously that all of the drugs significantly increased the risk of heart attack and stroke, in a 17-15 vote the panel said the FDA should allow Vioxx to remain on the market. A tally of the votes showed that without the 9 votes of the 10 members who consulted for the drug makers, the committee would have voted 14 to 8 to ban Vioxx.

However, the panel's recommendation was met with scorn and outrage by medical experts and researchers alike in the media, and in a rare occurrence, the FDA went against the recommendation of its advisory panel and refused to allow Vioxx to remain on the market.

Critics also accuse the FDA of not properly monitoring the marketing activities of the pharmaceutical industry. An investigation by the House Committee on Government Reform found that since December 2001, there has been a sharp decline in enforcement actions taken against drug companies for illegally promoting their products.

The investigation determined that from 1999 to 2001, the FDA sent out 250 "Notice of Violation" or "Warning" letters to drug companies; but for the time period of 2002 through 2004, the agency sent out only 70 letters, which amounts to a reduction of more than two-thirds.

Since the Vioxx and SSRI debacles, Senator Grassley has jumped on the FDA every time there has been any indication that officials might be putting the industry's interest over public safety. Earlier this year, he wrote a letter to the FDA saying he was concerned that it might be "dropping the regulatory ball" on stimulant drugs, prescribed to treat ADHD.

Specifically, he wrote, "I'm concerned FDA's regulatory responsibilities haven't kept pace with the explosion of prescriptions written to treat 2.5 million children with these drugs."

Despite psychiatric and cardiovascular risk signals associated with the drugs, he noted, it appears the FDA has failed to promptly respond to their possible adverse effects. "Such events," he wrote, "may include sudden unexplained deaths, strokes, cardiovascular irregularities or aggression, anxiety and depression."

Sales of drugs, he said, "have zoomed to the moon, jumping from $759 million to $3.1 billion between 2000 and 2004."

"And yet," he wrote, "the FDA seems to have adopted a wait-and-see approach before charting a course of action to study these risks."

In early February 2006, he noted, that an advisory panel had recommended adding the strongest black box warning to ADHD drugs to alert patients about the possible cardiovascular side effects.

"The recommendation," Senator Grassley wrote, "brings even more urgency to the controversy surrounding the explosion of prescriptions being filled with these medicines."

"As the debate unfolds," he warned agency officials, "I will continue to closely track the FDA and urge its timely, thorough review of these drugs."

"With millions of Americans, mostly children, regularly taking these medications," he added, "it is essential the FDA leaves no stone unturned to investigate and review this class of drugs."

No doubt in response to all the intense scrutiny from members of Congress, in late July 2006, the FDA outlined a series of changes it plans to make in the methods used to evaluate clinical trials. One of the proposed changes would require a drug company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial.

As it is now, drugs companies are trusted to remove unreliable data and are not required to report any fraudulent activity to the FDA until they actually submit the application.

The agency also says it plans to clarify which adverse events in clinical trials must be reported to the review boards that monitor the studies. Other proposed change includes the standardization of forms used to collect information and a revision of the rules on how patients may qualify to participate in clinical trials.

However, people who are tempted to think that the FDA is capable of changing under the agency's current team of politically appointed officials, had better think again.

According to an article by Russell Mokhiber and Robert Weissman, for Common Dreams on August 2, 2006, Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: "Government Science Panels: Fair and Balanced?" which was moderated by National Public Radio's Snigdha Prakash, and sponsored the Center for Science in the Public Interest.

Dr Nissen spoke about the conflict-of-interest problems "evident at the highest levels of the FDA," the article says.

"For years," Dr Nissen said in describing FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."

"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict," he noted.

"In his role as director of the National Cancer Institute," Dr Nissen said, "Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."

But even worse, he said, "the administration appointed Scott Gottlieb as deputy commissioner."

"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter," Dr Nissen stated.

"Between them," he said, "Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."

"So while the American people worry about the safety of drugs," he continued, "the top FDA leadership tells us we need faster drug approval."

On November 12, 2005, the Boston Globe reported that prior to his job at the FDA, Dr Gottlieb worked for the PR firm of Manning Selvage & Lee and that his clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the maker of Ketek, and the parent company to the nation's sole flu vaccine maker.

According to the Globe, the Manning PR firm paid Dr Gottlieb a monthly retainer of $12,500 for nine months, for working on projects that involved eight companies. Other firms regulated by the FDA that he was involved with include Inamed Corp, a company seeking the return of silicone gel implants to the market.

Between May and July 2005, Dr Gottlieb also was paid $9,000 for consultant work performed for VaxGen, a company that won an $878 million government contract to supply the US with 75 million doses of anthrax vaccine.

In any event, no matter who's in charge, the Senator from Iowa is keeping the heat on. In July 2006, he wrote a letter to the Daniel Levinson, the Inspector General at the Department of Health and Human Services, asking for an investigation into whether Dr Brian Harvey of the FDA, conspired against Dr Graham by providing Merck with details about Dr Graham's presentation on Vioxx, prior to the hearing in 2004 to help the company refute his testimony.

"It is no secret that Dr. Graham was and is a critic of the FDA," he wrote to Inspector. "However," he said, "that does not mean the FDA should scheme with drug sponsors to discredit its own employees."

Evelyn Pringle
evelyn.pringle@sbcglobal.net

Information for parties harmed by pharmaceutical products can be found at Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/fda_pharma.html

Posted by MBVIC at 1:17 PM | Permalink

By Gregory Roumeliotis

Buoyed by lucrative biodefense contracts, Emergent BioSolutions has showcased a new large-scale vaccine production facility in Michigan which it will use to make Biothrax, the only vaccine approved in the US for the prevention of anthrax infection.


Construction of the 50,000-square-foot facility in Lansing is expected to finish next year, with manufacturing operations starting in 2008 and supporting the company's other two manufacturing plants in Frederick.

In an age of widespread terrorism fears, anthrax is considered by the US government to be one of the top biothreat agents, resulting in booming business for Emergent BioSolutions, which gets 97 per cent of its revenues from government contracts, primarily the US Department of Health and Human Services and the US Department of Defense.

Last week the company announced it will sell shares of stock in an initial public offering (IPO) that could raise as much as $86m (€65m), making it an attractive proposition for investors not just because of its past performance – few biotech companies have been profitable for three years in a row – but also because of its prospects.

Emergent BioSolutions already has guaranteed income for 2007 after signing a $120m deal to deliver 5m doses of BioThrax vaccine to the US government, all it needs now is capacity, hence the new facility.

“This building represents a major investment in our biodefense business, and significantly expands our core manufacturing capabilities,” said Emergent BioSolutions CEO Fuad El-Hibri.

“When we purchased this facility from the state in 1998, we could only dream of being where we are today and with the support of our employees, our customers, the city of Lansing, and the state of Michigan, that dream is now a reality.”

The company was set up in Michigan in May 1998 under the name BioPort but a reorganisation made it a subsidiary of the larger Emergent BioSolutions.

Its lead and only product on the market, Biothrax, is unlikely to remain the only anthrax vaccine approved by the US Food and Drug Administration (FDA) for long; VaxGen has already been awarded an $877.5m contract by the US Department of Health and Human Services to provide 75m doses of a modern anthrax vaccine, currently in dvelopment, while Human Genome Sciences has won a $165m contract to supply 20,000 of its candidate which has reached Phase I.

Biothrax is a sterile, milky-white suspension made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, the microbe that causes anthrax.

The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts and sugars.

The final product, prepared from the sterile filtrate culture fluid, contains proteins, including the 83kDa protective antigen protein released during the growth period.

It contains no dead or live bacteria and is formulated to contain 1.2mg/mL aluminum, added as aluminum hydroxide in 0.85 per cent sodium chloride.

Emergent BioSolutions is using the revenue Biothrax is generating to move other vaccines through its pipeline for Hepatitis B, chlamydia and meningitis B.

Posted by MBVIC at 1:10 PM | Permalink

The Examiner
by David Francis and Bill Myers

WASHINGTON - A microchip company with powerful political connections is lobbying the Pentagon for the right to implant chips under the skins of the nearly 1.4 million U.S. military personnel.


VeriChip Corp., which is based in Florida and planning to offer its stock to the public soon, has been one of the most aggressive marketers of radio frequency identification chips. Company officials have touted the chips as versatile, able to be used in a variety of situations such as helping track illegal immigrants or giving doctors immediate access to patient’s medical records.

Now the company is “in discussions” with the Pentagon, spokeswoman Nicole Philbin said. She added that VeriChip wants to insert the chips under the skin of the right arms of U.S. servicemen and servicewomen. The idea is to be able to scan an arm and obtain that person’s identity and medical history.

“The potential for this technology doesn’t just stop at the civilian level,” Philbin said.

VeriChip hopes that the chips will replace the metal dog tags that have been worn by U.S. military personnel since 1906.

The company has political muscle in the form of Tommy Thompson. A former secretary of the Department of Health and Human Services, Thompson is a partner at the lobbying law firm of Akin Gump and is a director of VeriChip.

Thompson said he’s sure that the chip is safe and that no one — not even military personnel, who are required by law to follow orders — will be forced to accept an implant against his or her will. He has also promised to have a chip implanted in himself.

But reached for comment Friday, he wouldn’t say when he was going to have the implant.

“I’m extremely busy and I’m waiting until my hospitals and doctors are able to run some screens,” he said.

The technology is not foreign to the Pentagon. The Department of Defense spent $100 million on similar chips that track supplies and has also attached microchips to dog tags.

But the idea of implanting the chips in live bodies has some veterans’ groups and privacy advocates worried.

“It needs further study,” said Joe Davis, a retired Air Force major and a spokesman for the D.C. office of the Veterans of Foreign Wars.

Liz McIntyre, author of a book critical of the chips, said that VeriChip is “a huge threat” to public privacy.

“They’re circling like vultures for any opportunity to get into our flesh,” McIntyre said. “They’ll start with people who can’t say no, like the elderly, sex offenders, immigrants and the military. Then they’ll come knocking on our doors.”

The chip also is drawing attention from Congress.

“If that is what the Defense Department has in mind for our troops in Iraq, there are many questions that need answers,” Sen. Patrick Leahy, D-Vt., said in an e-mail to The Examiner.

“What checks and balances, safeguards and congressional oversight would there be?” Leahy wrote. “What less-invasive alternatives are there? What information would be entered on the chips, and could it endanger our soldiers or be intercepted by the enemy?”

The company is not so sure about the technology, either. According to company documents, radio frequencies in ambulances and helicopters could disrupt the chips’ transmissions.

In a filing with the Securities and Exchange Commission, VeriChip also said it was unsure whether the chip would dislodge and move through a person’s body. It could also cause infections and “adverse tissue reactions,” the SEC filing states.

But Philbin downplayed the danger of the chips.

“It’s the size of a grain of rice,” she said. “It’s like getting a shot of penicillin.”

Posted by MBVIC at 11:29 AM | Permalink

NAA E-Newsletter
By Evelyn Pringle

In the wake of overhauling the FDA, lawmakers are also cracking down on conflicts of interest within the Centers for Disease Control. Last month, Representatives, Dr Dave Weldon (R-FL), and Carolyn Maloney (D-NY), held a press conference to announce the introduction of a bill that would give responsibility for vaccine safety to an independent agency within the Department of Health and Human Services, and remove most vaccine safety research from the CDC.


Specifically, they said on July 26, 2006, the "Vaccine Safety and Public Confidence Assurance Act of 2006," will create an independent office to address, investigate, and head off potential safety problems like the use of mercury in vaccines, in an objective and non-conflicted office whose sole purpose is vaccine safety and evaluation.


According to Dr Weldon in a prepared statement, Federal agencies charged with overseeing vaccine safety research have failed. They have failed to provide sufficient resources for vaccine safety research. They have failed to fund extramural research and they have failed to free themselves from conflicts of interest that serve to undermine public confidence in the safety of vaccines, he said.

"The American public deserves better," Dr Weldon stated, "and increasingly parents and the public at large are demanding better."

"There's an enormous inherent conflict of interest within the CDC," he said, "and if we fail to move vaccine safety to a separate independent office, safety issues will remain a low priority and public confidence in vaccines will continue to erode."

He said that similar conflicts have been remedied in other federal agencies, but in the vaccine program the conflicts persist unchecked. "This bill will provide the independence necessary," Dr Weldon said, "to ensure that vaccine safety research is robust, unbiased, and broadly accepted by the public at large."

"Vaccines do wonders for public health, but when the government requires them, it must also ensure that they're safe," Ms Maloney said in her statement. "We need adequate, unbiased research on vaccines, and this legislation would deliver that."

She applauded Dr Weldon for his tremendous commitment and leadership on the issue. "He is truly dedicated," she said, "to protecting our children and the public at large."

While announcing the new bill, Dr Weldon and Ms Maloney were joined by several groups advocating vaccine safety reform, including the National Autism Association, A-Champs, and safeMINDS.

According to the National Autism Association: "This landmark legislation will provide critical government agency oversight and implementation of vaccine safety research, which has not kept pace with the rise in the number of vaccines routinely prescribed to consumers including pregnant women and young children."

Additionally, the Act calls for $80 million in funding to conduct vaccine analysis and safety research.

Currently the CDC oversees vaccine research, safety and promotion, a situation that has been drawing more and more public criticism in recent years. The CDC compiles the list of vaccines that doctors are to give all children in the US, based on the recommendations of an advisory panel, and in many states kids can not attend day care or public schools unless they have received the CDC-endorsed vaccines.

A recommendation by the CDC guarantees a huge market for a vaccine and enables the drug company to use the government as a marketing device for its product. The annual global market for vaccines is expected to be over $10 billion this year.

On July 21, 2003, United Press International published a report based on a four-month investigation that found a pattern of problems linked to vaccines recommended by the CDC, as well as a web of close ties between the agency's advisory panel and the pharmaceutical industry.

By investigating members of an advisory panel of outside experts that make vaccine recommendations, UPI found that members of the panel received money from vaccine makers through relationships that included: sharing a vaccine patent; owning stock in a vaccine company; payments for research; money to monitor vaccine testing; and funding for academic departments.

In fact, according to UPI, the CDC itself is in the vaccine business. Under a 1980 law, UPI found the CDC had 28 licensing agreements with drug companies and one university for vaccines or vaccine-related products and eight ongoing projects to collaborate on new vaccines.

For instance, the CDC and SmithKline Beecham worked together on the Lyme-disease vaccine. A 1992 CDC activity report, obtained by UPI, says the agency had an agreement "with SmithKline Beecham that currently funds three positions at (the CDC) for the purpose of providing information of use in developing advanced test methods and vaccine candidates."

In June 2001, the General Accounting Office delivered a report on the issue to Senator Chris Dodd, (D-Conn), that noted that CDC employees "are listed on two Lyme-disease related patents" including "a 1993 joint patent between CDC and SmithKline Beecham Corporation." The report also said that six of 12 consultants working for the CDC on Lyme vaccines "reported at least one interest related to a vaccine firm."

According to CDC meeting transcripts where the committee weighed its recommendation, 3 had conflicts of interest with SmithKlineBeecham. The LYMERIX lyme-disease vaccine was approved by the CDC on February 18, 1999, and by October of 2000, more than 1.4 million people had received the vaccine.

But 18 months later, according to UPI, in February 2002, SmithKline Beecham
pulled the vaccine off the market claiming that sales of LYMERIX were insufficient to justify the continued investment. However, according to UPI, the company also faced hundreds of lawsuits by people who said they suffered side effects from the vaccines.

The government's database at the time, listed possible side effects from LYMERIX as 640 emergency room visits, 34 life-threatening reactions, 77 hospitalizations, 198 disabilities and six deaths after people took the shots since the CDC endorsed it, according to UPI.

UPI also found other cases where vaccines endorsed by the panel were pulled off the market after a number of people suffered devastating side effects, and some died.

Congressman Dan Burton, (R-Ind), had already been investigating the advisory panel for several years, and told UPI that the conflicts of interest were a major problem. "This presents a real paradox," he said, "when the CDC routinely allows scientists with blatant conflicts of interest to serve on influential advisory committees that make recommendations on new vaccines, as well as policy matters."

"All the while these same scientists," Representative Burton said, "have financial ties, academic affiliations, and other vested interests in the products and companies for which they are supposed to be providing unbiased oversight."

An August 2001 report on the investigation by Rep Burton's House Government Reform Committee, stated that "four out of eight CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine."

Critic say the conflicts of interest of Dr Paul Offit while sitting on the advisory panel could not be more blatant. He was part of the team that mandated the use of the RotaVirus vaccine, even though he received a $350,000 grant from Merck to develop the vaccine, shared the patent, and was paid to go around the country teaching doctors that vaccines were safe, according to the Wall Street Journal.

UPI discovered that Merck also had bought and distributed copies of a book written by Dr Offit titled, "What Every Parent Should Know About Vaccines," to physicians with a Dear Doctor letter that stated:"Merck Vaccine Division is pleased to present you with a copy of the recent publication, 'What Every Parent Should Know About Vaccines.'"

"The authors designed the book," Merck's letter told doctors, "to answer questions parents have about vaccines and to dispel misinformation about vaccines that sometimes appears in the public media."

The book had a list price of $14.95, and Dr Offit told UPI that he did not know how many copies Merck had purchased.

In 2001, Congressman Burton's investigation also found conflicts of interest with the then chairman of the advisory panel, Dr John Modlin, a Professor at Dartmouth Medical School, who owned $26,000 worth of Merck stock.

In a phone interview in 2003, Dr Modlin told UPI that he had sold the Merck stock, but that he had recently agreed to chair a committee to oversee Merck vaccine clinical trials.

"Meeting transcripts over the past decade," UPI says, "showed that at some meetings, half of the members present had potential conflicts with vaccine manufacturers."

For instance, at a June 2002 meeting, four of the 11 members on the panel acknowledged conflicts with Wyeth, GlaxoSmithKline, Merck, Pfizer, Aventis Pasteur, and Bayer.

The agency is currently facing a major credibility crisis over the issue of whether vaccines containing the mercury-based preservative, thimerosal, are responsible for the epidemic of neurological disorders ranging from ADHD to autism in children all across the country.

The CDC is being accused of research manipulation and cover-ups of vaccine maker culpability by an ever increasing number of activist groups and is also facing tough questions from some of the powerful members of Congress, both Republicans and Democrats alike.

The CDC continues to claim that there is no evidence to support a connection
between the epidemic and thimerosal, which they say is no longer used in most pediatric vaccines.

It is however, included in the flu vaccine currently recommended for all pregnant women and children more than 6 months old.

Earlier this year, a group of lawmakers initiated a new investigation of the matter and basically directed the CDC to butt out. On February 22, 2006, they stated in a letter: "If the federal government is going to have a study whose results will be broadly accepted, such a study cannot be led by the CDC," in a letter to Dr David Schwartz, Director of the National Institute of Environmental Health Sciences.

The letter was signed by Senators, Joe Lieberman (D-Conn) and Debbie Stabenow (D-Mich), and members of the House Representatives including, Dr Dave Weldon, (R-Fla) Chris Smith, (R-NJ), Carolyn Maloney, (D-NY), Dan Burton, (R-Ind), Joseph Crowley, (D-NY), and Maurice Hinchey, (D-NY).

The Institute of Environmental Health Sciences is part of the National Institutes of Health, and was asked to convene a panel to decide how to analyze the CDC database to determine whether autism rates have dropped since thimerosal was removed from most vaccines.

The controversy picked up traction in April, "National Autism Month," when world renowned heavy metal experts, researchers, and physicians traveled to Washington and rallied on Capital Hill moving the debate beyond just the parents of autistic children.

This spring, a full-page ad appeared in USA Today, the most widely-circulated newspaper in the US, and accused the CDC of "causing an epidemic of autism" by recommending that kids receive a series of vaccinations that contained thimerosal at least as late as 2001.

The ad quoted one of the most recent and famous advocates to join the cause, environmental lawyer, Robert F Kennedy Jr, as saying: "It's time for the CDC
to come clean with the American public."

The ad was funded by a coalition of advocacy groups led by Generation Rescue, and directed readers to the web site, www.PutChildrenFirst.org, to view internal CDC documents, many of which were obtained under the FOIA, that includes transcripts of meetings and e-mails that the groups contend support their allegations of a CDC cover-up.

Congressman Weldon has a theory about why the CDC continues the charade of denying the link between vaccines and autism. "If it is eventually determined that an entire generation of kids was essentially poisoned," he says, "a class-action suit against the federal government could be on the order of hundreds of billions of dollars, and so there's very good reason for them to try to cover this up."

And Dr Weldon's prediction is proving true. Vaccine injury lawsuits are being filed and won against the vaccine makers and the government. Implemented in 1988, the National Childhood Vaccine Injury Act of 1986, established a mandatory, federally administered no-fault claims process for individuals who allege that they were harmed by the administration of childhood vaccines.

The vaccine compensation fund was created to supposedly ensure an adequate supply of vaccines, and to stabilize vaccine costs. A small fee charged on each vaccines funds the program. According to statistics on the vaccine compensation web site, in fiscal year 2006, a total of $38.2 million has been paid out in cases involving 47 awards.

In what is reported to be one of the largest settlements ever, in July 2006, a quadriplegic boy was awarded $43.1 million. The case alleged that now 7-year-old, Mario Rodriguez, became a quadriplegic after receiving a measles, mumps and rubella vaccine on January. 25, 2000.

Under the guidelines of the vaccine compensation fund program, the lawsuit was filed against the Department of Health and Human Services. Kansas City attorney, Leland Dempsey, who represented the child, told the Kansas City Star: "One unusual aspect of the case is that Mario is expected to have a normal lifespan, and therefore will require more years of care that will cost more money."

"He will need round-the-clock care, including extensive medical intervention, throughout his life," Mr Dempsey said.

Many other vaccine related lawsuits have been filed against drug makers. For instance, Eli Lilly, the company that invented thimerosal back in the 1930s, informed its shareholders in its 2005 Annual Report filed with the SEC on April 1, 2006: "We have been named as a defendant in approximately 340 actions in the U.S., involving approximately 1,020 claimants, brought in various state courts and federal district courts on behalf of children with autism or other neurological disorders."

Lilly also stated, we believe that "the majority of the cases should not be prosecuted in the courts in which they have been brought because the underlying claims are subject to the National Childhood Vaccine Injury Act of 1986."

Under the Act, claims must first be brought before the US Court of Claims for an award determination under the guidelines established by the Act. However, as Lilly points out in its filing, "Claimants who are unsatisfied with their awards under the Act may reject the award and seek traditional judicial remedies."

Persons injured by drug companies can get information at Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/cdc_big_pharma.html

Evelyn Pringle
evelyn.pringle@sbcglobal.net

Authors Bio: Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

Posted by MBVIC at 8:04 AM | Permalink

Gazette Newswatch

Anthrax vaccine maker Emergent BioSolutions of Gaithersburg has filed for its initial public offering, largely to raise funds for developing several of its other products, according to a company filing this week with the U.S. Securities and Exchange Commission.


The company manufactures and markets BioThrax, the only anthrax vaccine approved by the U.S. Food and Drug Administration, to federal agencies such as the Pentagon and the Department of Health and Human Services, said company spokesman Robert G. Burrows. Burrows said the company is not yet disclosing the number of shares or prices in the IPO.

Revenues from BioThrax sales were $55.5 million in 2003, $81.0 million in 2004 and $127.3 million in 2005. However, the company expressed concerns in its SEC report that its federal contracts are not guaranteed and competition is increasing from other companies.

Posted by MBVIC at 4:54 PM | Permalink

By Steve Johnson
San Jose Mercury News
MCT)

SAN JOSE, Calif. - Almost five years after a deadly series of mailed anthrax attacks prompted warnings that a new anthrax vaccine was "urgently needed," the nation's nearly $1 billion effort to develop the drug is in trouble.


The company, VaxGen, is about a year behind schedule on its latest contract, the first and biggest under the federal anti-terror program Project BioShield. And the delay could grow by at least another year because of a dispute with the government over how the vaccine should be tested.

Although federal officials consider VaxGen's vaccine promising, critics have questioned why the small Brisbane, Calif., company won the contract. It has no commercial products, flopped at making an AIDS vaccine and has been delisted from the Nasdaq Stock Market since 2004 because of its fouled-up financial records. Yet the government had little choice, because major vaccine manufacturers declined to bid.

VaxGen blames much of the criticism it has received on a campaign orchestrated by its business competitor, and it claims it is making progress on the drug. But if it can't deliver the vaccine to federal specifications, the country will have to rely on the existing vaccine - one that some soldiers have refused to take because of its side effects, and that needs improvement, according to health experts.

Some people also fear VaxGen's contract flap could discourage the biotech industry - already wary of doing government business - from participating in future anti-terror efforts.

"An unresolved dispute here will not only leave the nation without a much-needed, next-generation anthrax vaccine," Rep. Tom Lantos, D-Calif., wrote federal health officials in June, "but will also undermine the development of a vibrant bio-defense industry."

Terrorism specialists long have considered anthrax the biological weapon of choice for extremists. It is relatively easy to obtain, can be dispersed over a wide area and secretes proteins that become highly toxic when they come in contact with human cells.

But the concerns were heightened dramatically in the weeks after the Sept. 11, 2001, attacks, when anthrax-contaminated mail sent to U.S. Senate offices and the media killed five people and sickened at least 17 others.

The United States already has an anthrax vaccine, AVA. Developed in the 1950s, it has been used to inoculate 1.3 million military personnel. But AVA has been linked to six deaths and unpleasant side effects, from fever to body aches. Hundreds of soldiers have refused to take it.

AVA also must be given in a series of six shots over an 18-month period, which health officials consider complicated. And because of the way AVA is made, the amount of its protective antigen varies from one production lot to another.

The National Academies' Institute of Medicine concluded in a March 2002 report that even though AVA is generally safe and effective, "a new vaccine, developed by more modern principles of vaccinology, is urgently needed."

So the government sought one that, among other things, could be genetically engineered with a more consistent amount of protection and require only three doses.

Armed with Project BioShield's $5.6 billion to combat terrorism over 10 years, federal officials in March 2004 offered $877.5 million to any company that could provide 75 million doses of a new vaccine. The drug would be set aside for civilians in the Strategic National Stockpile, a government storehouse of medicines for public emergencies.

Federal officials won't disclose the bidders. But VaxGen executives say they know of three other firms that responded: DynPort Vaccine of Maryland, Avecia of England and Panacea Biotec of India. Like VaxGen, all were relatively small.

Why didn't major drug companies, especially those familiar with vaccines, bid?

"We were pretty busy developing our own vaccines," said Janet Skidmore of New Jersey-based Merck.

Experts said firms feared they might be sued if the vaccine proved unsafe, saw little commercial potential for the drug and disliked the red tape involved in government contracts.

"They don't want the government stirring in their stuff," said Phillip Russell, former director of the Office of Research and Development Coordination for the U.S. Department of Health and Human Services, which oversees the anthrax vaccine contract. "It's painful."

Executives at VaxGen - which has about 300 employees and was founded in 1995 as a spinoff of biotech giant Genentech - say they deserved the contract.

Before joining VaxGen as its chief executive in 2001, Lance Gordon invented a federally approved infant-meningitis vaccine and produced a smallpox vaccine for the government. VaxGen also had licensed a military-developed anthrax vaccine. And it already had gotten federal contracts in 2002 and 2003 totaling $101.2 million to refine that anthrax vaccine to replace AVA.

After VaxGen won the BioShield anthrax contract on Nov. 4, 2004, however, concerns were raised in the media and elsewhere about the company's past.

VaxGen was created with the mission of developing an AIDS vaccine. But after spending years trying, the company concluded in 2003 that its vaccine was generally ineffective.

VaxGen executives also disclosed in 2004 that they had been incorrectly understating their government contract revenue, based on the advice of their former accountants. And the executives concluded in July 2005 that they hadn't properly accounted for VaxGen's 2002 investment in a company called Celltrion.

Because it has been conducting an ongoing review of its books to correct the problems, VaxGen executives say, the company hasn't filed financial reports with the U.S. Securities and Exchange Commission for the past two years.

Three months after the BioShield contract was awarded, Sen. Charles Grassley, R-Iowa, wrote the Department of Health and Human Services that "questions have been raised as to whether HHS acted prematurely and relied on insufficient data to support the VaxGen contract."

VaxGen blames such grumbling mostly on its main competitor, Emergent BioSolutions of Maryland, which makes the existing anthrax vaccine, AVA.

Emergent has spent about $1.6 million lobbying Congress and other federal officials since 2003, four times as much as VaxGen, according to U.S. Senate records. Emergent also has been deft at luring influential directors, including former Health and Human Services Secretary Louis Sullivan, who joined Emergent's board in June, and Adm. William Crowe, former chairman of the Joint Chiefs of Staff, who was on the board until last year.

Emergent spokeswoman Kim Brennen Root acknowledged her firm lobbied Grassley and others. She said it was partly to convince them AVA was at least as good as VaxGen's vaccine and that the government should buy AVA for civilians, not just for the military.

The lobbying seems to have paid off. Since last year, Emergent has gotten contracts totaling $242.7 million to provide 10 million doses of AVA for the civilian Strategic National Stockpile.

So VaxGen has fought back. Testifying in Congress in July last year, VaxGen's CEO Gordon blasted Emergent for having "misstated facts" about his company.

Under its BioShield contract, VaxGen gets paid only when it begins delivering the vaccine to the government, which the company initially said would happen early this year. But VaxGen says a glitch in the drug's formulation forced it to put off deliveries until later this year or early 2007.

Problems also have arisen with the Department of Health and Human Services. VaxGen has had mixed results with two studies of the vaccine in people, which were intended to check how safe it is and what sort of immune response it generates. But it claims the agency is demanding a contract modification that would force the company to do more costly tests, not originally required.

One additional test, VaxGen executives say, would be in people. The other test, they say, would evaluate how well its final formulation protects animals from anthrax, since that can't be tested in humans.

The changes will slow the vaccine's development, possibly delaying the start of deliveries and VaxGen's payment until late 2008, the company's executives claim.

Dr. Noreen Hynes, who now directs the agency's Office of Research and Development Coordination, wouldn't discuss the vaccine contract in detail, saying its terms are confidential. But she disputed VaxGen's claim about having to do more work.

"There are no new requirements," she said.

VaxGen estimates it will have spent $150 million of its own money on the vaccine by the end of this year, besides the $101 million it has received so far from the government.

Vaxgen's contract for the vaccine is the largest of eight issued so far by Project BioShield totaling $1.7 billion. But even with BioShield's overall budget for $5.6 billion, much more money will be needed to counter terrorism and make the program attractive to business, said Brad Smith of the University of Pittsburgh's Center for Biosecurity.

He also favors bills pending in Congress that would make it easier for VaxGen and other BioShield contractors to get some payment before they deliver their products.

"BioShield is an important first step," Smith said, but he added, "it clearly needs more work."

Convincing businesses to participate in Project BioShield could get even harder because of VaxGen's contract dispute with the government. If the government's disagreement with VaxGen can't be resolved, said Lance Ignon, VaxGen's vice president of corporate affairs, "we are going to preserve our right to litigate."

That could be a big red flag to other companies.

"This is the first major contract," said Chris Colwell, a regulatory specialist with the Biotechnology Industry Organization. "Many people are watching this."

---

TROUBLED QUEST FOR VACCINE

The challenge: In March 2004, the government offers $877.5 million to any company that could provide 75 million doses of a new anthrax vaccine.

The bidding: With major drug companies passing, VaxGen wins the bid in November 2004. First delivery expected in early 2006.

Sign of trouble: In March 2005, VaxGen reports that two studies of the vaccine in people return only mixed results and says the first delivery would be delayed.

First results: Two studies of the vaccine in people return only mixed results.

Big dispute: VaxGen says the government wants more, costly testing. The government disputes that claim.

What now: Best-case scenario is first vaccine delivery later this year, but fight over testing could delay it until 2008.

---

DELIVERY SCHEDULE

VaxGen hasn't said publicly when it expects to finish delivering all 75 million doses of its anthrax vaccine under its Project BioShield contract. But it has warned it could be delayed by more than three years, because of a problem with the vaccine's formulation and what the company claims are additional study requirements imposed by the government. According to VaxGen, here are the delivery dates under the initial contract and under a government contract modification in May:

Under original 2004 contract:

Early 2006: Begin delivering vaccine to government.

November 2006: Complete delivery of 25 million doses.

May 2007: Complete delivery of 50 million doses.

December 2007: Complete delivery of 75 million doses.

Under contract modification:

Late 2007 or sometime in 2008: Begin deliveries.

Oct. 25, 2009: Complete delivery of 25 million doses.

June 27, 2010: Complete delivery of 50 million doses.

Feb. 7, 2011: Complete delivery of 75 million doses.

Source:VaxGen

Posted by MBVIC at 4:45 PM | Permalink

By Steve Johnson
San Jose Mercury News

SAN JOSE, Calif. - Although VaxGen has received nearly $1 billion in federal contracts since 2002 to make an improved anthrax vaccine, it's not yet clear whether the vaccine will be better than the existing one, known as AVA.


VaxGen's main responsibility is to make a vaccine that is more consistently pure than AVA, according to VaxGen executives and government officials. That may result in a vaccine that is more effective, causes fewer side effects and requires only three doses, instead of the six needed with AVA. But the government isn't insisting on those improvements, they said.

Studies comparing the two vaccines so far provide a mixed picture. Both can prevent fatal anthrax infections in animals. But determining how the drugs would perform in people is more difficult.

Exposing people to a disease to test a vaccine's effectiveness is considered dangerous and unethical. So VaxGen's tests in people check to see if the drug is safe and can bolster the person's immune system, making them more resistant to anthrax.

The first of two studies VaxGen conducted in people compared VaxGen's vaccine with AVA. It found both vaccines seemed to work by triggering an immune response. But those receiving AVA had more instances of arm pain from the injections, while those taking VaxGen's vaccine were more likely to complain of mild headaches and fatigue.

It's hard to draw conclusions from that study, in part because the number of people participating, 100, was so small, said Dr. Harry Keyserling, an Emory University professor who oversaw the study.

The second test, with about 500 people, made no effort to compare VaxGen's vaccine with AVA. It measured how effective VaxGen's vaccine could be when a booster ingredient is added.

That test turned up a problem, the company reported in March 2005. Instead of improving the immune response, the booster lowered it. VaxGen executives say they have since adjusted the vaccine's formula to fix the problem. They plan to begin a third test in people this summer.

The executives said their BioShield contract also required a fourth study in people. They claim the government has also demanded that a fifth study be done, which would delay the vaccine's delivery, and postpone payments to Vaxgen.

Government officials deny adding any new study requirements.

Posted by MBVIC at 4:09 PM | Permalink