November 28, 2005

Germ Boys and Yes Men


Cheney, Libby, Judith Miller, Iraq, mass vaccination....money. Finally, someone starts to connect the dots....

The Nation
by JEREMY SCAHILL

In early November George W. Bush, struggling to claw his way upward in polls that had acquired the consistency of quicksand after two months of blunders and disasters, launched a new PR blitz. The Administration declared it was taking charge of the nation's health and security with an all-out war on the flu (to be conducted with vaccines provided by well-connected pharmaceutical companies). "Our country has been given fair warning of this danger to our homeland," Bush declared. "It's my responsibility as President to take measures now to protect the American people."

But if Bush hoped to wipe away the stain of Katrina--and the memory of a hapless Michael Brown steering FEMA in circles while New Orleans drowned--he should have thought twice about bringing up the specter of a public health emergency, because the man responsible for coordinating the federal response to a flu pandemic or bioterror attack could well be the next Michael Brown.

Meet Stewart Simonson. He's the official charged by Bush with "the protection of the civilian population from acts of bioterrorism and other public health emergencies"--a well-connected, ideological, ambitious Republican with zero public health management or medical expertise, whose previous job was as a corporate lawyer for Amtrak. When Col. Lawrence Wilkerson, former chief of staff for Secretary of State Colin Powell, recently speculated, "If something comes along that is truly serious...like a major pandemic, you are going to see the ineptitude of this government in a way that will take you back to the Declaration of Independence," many of those professionally concerned with such scenarios couldn't help thinking of Simonson. They recalled his own unsettling words at a recent Homeland Security subcommittee hearing on government response to a chemical or biological attack: "We're learning as we go."

"Great. What we need in the middle of a crisis is somebody learning on the job at that high level of government," says Jerry Hauer, Simonson's immediate predecessor at the Office of Public Health Emergency Preparedness (OPHEP) and a veteran public health expert who served as Rudy Giuliani's director of emergency management from 1996 to 2000.

"If I was in charge, he wouldn't be in that position," says Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University. "We don't have the best and brightest in the key positions, and this leaves us in a very, very precarious situation."

So how is it that Simonson ended up in a position that could impact the lives and health of millions? Simonson's qualifications can be summed up in two words: Tommy Thompson. Simonson was a protégé of the former Health and Human Services secretary and longtime Republican governor of Wisconsin. Thompson hired him out of the University of Wisconsin Law School in 1995 and put him on the political fast track, eventually naming him as his legal counsel. Thompson then used his influence as chair of Amtrak's board to place Simonson as the rail service's corporate counsel. When Bush named Thompson as HHS secretary, Simonson again went with him, and he has been rising through the ranks of the Administration and the Republican Party ever since. "He's a political hack, a sycophant," says Ed Garvey, a prominent Wisconsin attorney and the state's former deputy attorney general. "People just laughed when he was appointed to Amtrak, but when the word came out that he was in charge of bioterrorism, it turned to alarm. When you realize that people's lives are at stake, it's frightening. It's just one of those moments when you say, Oh, my God."

What is particularly disturbing to public health professionals and others is that Simonson is in charge of insuring that the country has adequate vaccines and antivirals to combat an avian flu outbreak. "Mr. Simonson is a lawyer, not a medical expert," declared Representative Henry Waxman, who highlighted Simonson in a list of five "inexperienced individuals with political connections." The California Democrat warned that the appointment of people like Simonson has "led to legitimate public concern that those in government, particularly those who are relied upon to keep us safe from harm, are not competent or independent in their judgments." As evidence of this, Waxman cited Simonson's July appearance before the House Government Reform Committee, where Simonson "claimed he had sufficient funds to purchase influenza vaccine and antiviral medication for the nation. The next day his office submitted a funding request to Congress seeking an additional $150 million for flu vaccine and antiviral medication."

But it is Simonson's acquiescence in the Bush Administration's reordering of priorities in the name of the "war on terror" that has most distinguished him throughout his career at HHS. Shortly after 9/11 Thompson and Simonson began plans to create an office within HHS dedicated to combating terrorism, which became OPHEP. "When Stewart came into this, he was deputy counsel to the secretary and a very close friend of the secretary's," says Donald "DA" Henderson, named by Thompson as the founding director of OPHEP, who was given the Presidential Medal of Freedom by Bush. "Within a short period of time, this became all [Simonson] was doing--without a title."

In mid-2002, as the White House aggressively sought to convince the world that Iraq possessed weapons of mass destruction, it was engaged on another front of the propaganda war at home: convincing Americans that Saddam was poised to deploy biological weapons in an attack on American soil. It was a battle that would pit Vice President Cheney and his now-indicted chief of staff Lewis "Scooter" Libby against a team of public health experts at HHS, led by then-OPHEP chief Jerry Hauer. Inside HHS it was Simonson who emerged as the White House's key strategic ally.

From his days as Defense Secretary during the Gulf War, Cheney was intensely interested in biological warfare. Libby, who worked for Cheney as an under secretary from 1990 to '92, shares his boss's obsession with biowar. Known in the Administration as "germ boy," Libby was obsessed with pre-emptively vaccinating the entire population against smallpox. (The fixation even extended to Libby's 1996 novel, The Apprentice, about a smallpox epidemic.) Shortly after 9/11 Cheney and Libby were briefed on a war game called Dark Winter, which simulated a smallpox attack on the United States. Interestingly, New York Times reporter Judith Miller, who penned a book called Germs, had taken part in the exercise, playing a reporter covering the attack. "It's a dramatic briefing," Libby told the Washington Post, "but we were well on this road already." Libby said that Cheney advocated "a forward-leaning position on protecting Americans from this threat."

Many in the public health community regarded Cheney and Libby's calls for mass smallpox vaccinations as fearmongering. Hauer, who also took part in Dark Winter, was among those asking uncomfortably probing questions. Hauer butted heads directly with Libby and his deputy on homeland security, Carole Kuntz. Another veteran of the first Bush Administration, Kuntz was Libby's special assistant at the Pentagon when Cheney was Defense Secretary. "The risks of vaccinating the whole country were greater than what we saw as the threat," says Hauer. "You're so focused on smallpox you lose perspective on all the other planning you're trying to do and nobody could make a good medical or public health case." Hauer, who ultimately would have been in charge of implementing Libby's program, says he had no choice but to oppose the plan. "There were times I felt you had to not be a yes man. You do an enormous disservice when you do that." Hauer says that when he raised objections to mass smallpox vaccinations, Kuntz became "downright offensive." Hauer adds, "It was very clear that I was not giving her the answers she wanted or telling her what she wanted to hear."

Like so many other instances when expert knowledge was discarded in the run-up to war, the bioterror obsession could well have long-term consequences. "It has been four years of throwing money at a perceived threat with very little to show for it," says Columbia's Dr. Redlener. Many public health experts say that the billions spent preparing for these imagined threats have left the country dangerously unprepared for actual ones, including the very real possibility of an avian flu outbreak, which is only now being addressed.

Cheney's office was eventually forced to back off its call for universal vaccinations, but the Administration persisted in hyping the threat of a bioterror attack. In early 2003 Bush announced a major biodefense initiative during his now infamous State of the Union address, laced with references to Iraq's alleged WMDs, including the fraudulent evidence about Iraq attempting to import uranium from Niger. Bush spoke of the prospect of terror attacks with anthrax, botulinum toxin, Ebola and plague. "We must assume that our enemies would use these diseases as weapons," he told the nation. The $6 billion plan was called Project Bioshield. Bush named Cheney as his point man on the project; at HHS it was Stewart Simonson.

Bioshield quickly became the main focus of OPHEP's work. For eighteen months, according to current and former HHS officials, Simonson worked diligently with Cheney's office to win Congressional approval for the program. Cheney scared up support for the plan, personally telling lawmakers Bioshield was "life on the planet stuff." Henderson says that Simonson's close contacts at the White House were "very helpful working with the Bioshield legislation."

At the time, Hauer was still heading OPHEP, while Simonson was Thompson's deputy legal counsel. According to former and current HHS officials, a power struggle developed between Hauer--who had already angered the Vice President's office with his opposition to the smallpox plan--and the well-connected Simonson. Hauer was critical of the way Bioshield was being thrown together and disagreed with Simonson on the priorities emerging within HHS, which increasingly privileged "war on terror"-related programs over preparing city and state governments and agencies for disasters, as well as over plans vital to public health, like preparing for a flu epidemic.

"Bioshield was a disaster," says Hauer. "It was done half-assed.... Instead of doing it right, they rushed to get it done so that they could announce it in the State of the Union." Hauer alleges that while Bioshield was being developed, the White House political office, led by Karl Rove, was seeking to undermine his authority. A couple of years before, Hauer, a Democrat, had aroused the ire of his former boss, Rudy Giuliani, after he publicly endorsed Mark Green over Michael Bloomberg in the 2001 New York City mayoral race. When he subsequently went to Washington to work for HHS, his title remained "acting" assistant secretary because the White House refused to officially approve his appointment. "The White House was not going to confirm me, particularly after the folks in New York were calling saying I supported a Democrat. I'm a Democrat. It was as simple as that." Still, he says, Thompson backed him and retained him at HHS despite the political pressure.

By March 2003, however, Hauer had been stripped of much of his authority, and he knew his days were numbered. Simonson intervened to prevent Hauer from attending a briefing in Thompson's office on Bioshield. In a March 24 e-mail to Thompson's briefing coordinator Simonson wrote, "Bioshield does not involve Jerry so I am unclear as to why he invited [sic]."

With the 2004 election a year away, and the environment at the agency becoming more hostile, Hauer says he could not in good faith continue to work for the Administration. "The political side of this White House is very vindictive," says Hauer. He says it was made clear to him that if he was not willing to endorse the President and "attend events," it was time to move on. "I don't want to be disrespectful of the office of the presidency," Hauer says. "I just felt that things needed a change, so I could not be part of the Administration and not support the White House. Plus, the fact is there was enormous frustration at HHS in large part because of Stewart."

In April 2004, with Hauer out of the way, Bush named Simonson director of OPHEP. Hauer says that with Simonson the Administration has "somebody they know will go along with pretty much anything they want." On July 21, a day before the 9/11 commission issued its findings, Bush signed Bioshield into law. The White House released a statement saying, "Today's action is just the latest step the President has taken to win the War on Terror and protect our homeland."

Even within the "war on terror" community, Bioshield has proved controversial. That's because more than 80 percent of the nearly $1 billion allocated under the program has gone to a scandal-plagued company that has never successfully produced an FDA-licensed vaccine. In November 2004 California-based VaxGen was handed one of the largest government vaccine contracts in history. The company is largely known for its failed AIDS vaccine, and just a few months before VaxGen won the Bioshield contract, the Nasdaq took the unusual step of delisting it from trading because of financial irregularities. So why did it get the contract? "I have no idea why VaxGen was selected," admits Henderson, who remains chair of the influential Secretary's Advisory Council at HHS. "It's not for me to decide whether it's a good idea or not." But it was for Simonson and his staff. And as with many Bush Administration contracts, several signs point to cronyism as the deciding factor--among them: VaxGen CEO Lance Gordon is a longtime associate of one of Simonson's top deputies on Bioshield, Dr. Phil Russell, former chief of Army medical research.

Now a powerful group of Republican lawmakers is pushing "Bioshield 2" through Congress. The legislation would strip people injured by vaccines of their right to sue manufacturers and would virtually eliminate pharmaceutical corporate accountability. The legislation would also make the newly created Biomedical Advanced Research and Development Agency the only federal agency exempt from the Freedom of Information Act.

Simonson did not return numerous messages left for him at his office. But Thompson stands by him, as does Henderson. "This is not necessarily somebody who has got a lot of depth of background here, but you can get people who have a variety of expertise. I would liken it to having a CEO in a company," says Henderson, adding that Simonson "may not have been qualified but he is a real learner.... We are where we are today because Stewart pressed this very hard. He read a lot, he talked a lot, he learned a lot."

Perhaps not quite enough, because where we are today, according to many public health experts, is unprepared.

Posted by MBVIC at 7:25 AM |

November 25, 2005

Doubts fail to halt U.S. anthrax plan


By Thomas Maier
Newsday

The nation is spending more than $1 billion for vaccines some officials say aren't effective. America's homeland-defense program is spending more than $1 billion on anthrax vaccines earmarked for wide civilian use despite uncertainty about their effectiveness and an ongoing debate about potential health problems, Newsday has found.

The vaccine stockpiling is a key element of the federal Project BioShield program, awarded $5.6 billion in funding in 2004 to develop drugs and vaccines to protect Americans against biological and chemical attacks. It constitutes the largest federal effort to protect civilians from an anthrax attack.

In May, BioPort Corp., the only manufacturer licensed in the United States to produce an anthrax vaccine, won a $123 million contract to make 5 million new doses for the public. Earlier this month, federal officials doubled their request.

In November 2004, another company, California-based VaxGen, received an $877 million contract, plus up to $69 million in other potential fees, to manufacture 75 million doses of an updated vaccine.

The product, which still lacks approval by the U.S. Food and Drug Administration, will not be available until 2007, company officials say.

Federal officials say an airborne anthrax attack could kill thousands of people in an urban setting and tout the vaccines as key parts of the civilian-defense program.

Though a body of scientific research shows that the current vaccine is effective if administered before skin exposure to anthrax -- and the rate of serious side effects is comparable to other common vaccines -- several public-health experts have raised questions about the vaccine's safety and whether it would work after an airborne attack.

Professor: Antibiotics best

David Ozonoff, a professor at Boston University's School of Public Health, said there was "scant" evidence the vaccine will work to treat people who inhale the airborne spores.

He said studies show antibiotics as the most effective treatment, and that the vaccine could cause potentially serious health problems among civilians.

Hillel W. Cohen, an epidemiologist at the Albert Einstein College of Medicine in the Bronx, agreed.

"The only possible benefit of a vaccine is if there's a danger of exposure, and that danger is small because of the technological hurdles of weaponizing anthrax," Cohen said. ". . . It's not something you can do in your basement."

If an anthrax attack were to occur today, the nation would rely on stocks of the BioPort vaccine, which, like the VaxGen product, would be provided in combination with antibiotics.

The only major study of the use of the BioPort vaccine after inhalation exposure found it ineffective on laboratory animals unless used in conjunction with antibiotics.

Animal trials under way

VaxGen also is conducting animal studies of its vaccine, but company officials say they are not certain it will work safely and effectively on humans exposed to airborne anthrax attacks.

"We'd hopefully achieve a high level of protection, and the alternative is severe disease," said Harry Keyserling, a pediatrics professor at Emory University School of Medicine in Atlanta and a key researcher in early VaxGen trials.

The issue of whether the vaccines themselves may cause health problems, and even death, also remains in dispute.

In documents of the FDA, Newsday found reports of more deaths and serious health problems among anthrax-vaccine takers than previously reported.

Until late last year, the FDA had listed reports of six deaths and 1,850 "adverse" reactions since 1990, ranging from minor redness at the inoculation site to severe cardiovascular and respiratory-system problems, that "possibly" were caused by the BioPort vaccine.

However, in a little-noticed report issued in December, the FDA said 16 deaths were possibly linked to the BioPort vaccine.

After Newsday asked about other fatalities cited in FDA filings, the agency upped the total number of fatalities possibly linked to the vaccine to 21.

The same report tallied more than 4,100 illnesses, including 347 it characterized as "serious," as possibly associated with the vaccine.

Posted by MBVIC at 6:43 AM |

November 23, 2005

Ky. Air Guardsmen Say Anthrax Vaccine Caused Ongoing Health Problems


Wave 3
Online Reporter: Eric Flack
Online Producer: Michael Dever

There are serious accusations against the military, and they're coming from
within ranks. Two Kentucky Air National Guardsmen claim a required vaccine has caused them major health problems. As WAVE 3 Investigator Eric Flack reports, this is not the first time the anthrax vaccine has been the center of controversy.

Kentucky Air National Guardsman Lucas Coffey used to dream of becoming a
pilot. Now he just dreams of being healthy again.

On April 24, 2003, Coffey was sitting in his room at Ramstein Air Force Base, Germany, when according to medical records obtained by WAVE 3, he suffered what is known as a "Grand Mal" seizure.

"I remember about three seconds of it," Coffey said, "and my roommate saying, 'We need help, call 911! Call 911!"

The kind of seizure Coffey was having is considered the most serious kind.
His bunkmates watched as Coffey shook violently, fearing he was gagging on his own tongue.

"Your head pulls to the right," Coffey recalled. "Your eyes roll behind you're head. You're biting, you're gripping so hard you pop your thumbs."

The seizure came just 12 days after Coffey received the anthrax vaccine in preparation for a possible deployment to Iraq. The military says the vaccine is safe -- and mandatory.

Col. Mark Kruas with the 123rd Airlift Wing said he has suffered no ill effects from the vaccine. "I know I take vaccinations like everybody else -- have for about 30 years. And I haven't had any difficulties myself."

But Coffey's seizure was just beginning. Less than two weeks after the first
one, Coffey says he had another. That time, he felt twitching in his leg, and blacked out.

In medical notes, a military doctor called the seizures "an allergic reaction" and wondered if they were "related to the immunizations."

Coffey was put on anti-seizure medication and sent back to Louisville.

Now more than two years later, he says the seizures continue. "It's horrible. It's tremendously hard."

Coffey is now convinced the anthrax vaccinations caused his seizure disorder. He is not the only one to make that claim.

Aaron Haycraft, who was also a member of the Kentucky Air National Guard, suffered vision loss and paralysis after he got the vaccine in 2002.

In response to questions about the safety of the anthrax vaccine, a military
spokesman sent us two Army studies which show no increased health risks for service members who were vaccinated.

In fact, the Air Force initially refused to give Aaron Haycraft medical discharge, saying there was no evidence linking his problems to the anthrax vaccine. But after a prolonged, public fight, the Air Force did an about face.

Haycraft received a medical discharge and a disability pension.

But Coffey has been denied disability by the Air Force, which ruled that he "had not produced any medical evidence" of a "chronic seizure disorder."

The evaluation board recommend Coffey be discharged, with only severance pay, which comes to just 10 percent of his base salary -- "$700 after taxes," Coffey said. "That's almost laughable."

Coffey has appealed, and recently sent the medical evaluation board a letter from a private neurologist in Louisville, who confirmed Coffey's ongoing seizures, and believes there is only a slim chance they will ever end.

And that leaves Coffey at a dead end, not knowing what to do, now that he can't do what he loves most.

"I think about it every day," Coffey said. "Every time I pass an airport, I think about it. It's so devastating, no doubt about it."

While a military spokesman said he could not specifically comment Coffey's case, he says the anthrax vaccine has been safely given to military personnel since the 1950s, and is still being administered routinely.

As for Coffey's appeal to be granted a medical discharge with full benefits, he's been awaiting a decision for months. We'll let you know how it turns out.

Posted by MBVIC at 8:27 PM |

Pharma To Republicans - Time To Pay Up Again


Op-Ed News
by Evelyn Pringle

The generation of children injured by vaccines containing the mercury-based preservative thimerosal is now reaching puberty. Many of these children will require life-long care and support. The cost to their parents by today's standards, will reportedly exceed $2 million dollars for each child.

An ever-growing number of health care professionals point to thimerosal as the culprit behind the explosion in cases of autism and other neurological disorders. The only common thread connecting these damaged children to one another is their exposure to mercury through childhood immunizations.

Accountability from vaccine makers is something that parents of injured children have been seeking for years; but accountability appears more illusive with each year's passage. On October 27 2005, the Hartford Courant reported that "Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people."

The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S 1873), is being pushed through Congress without giving voters the chance to make their objections known to their elected officials.

Nicknamed "Bioshield Two," the bill's primary sponsor, Senator Richard Burr (R-NC), claims the Act will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."

Co-sponsored by Senators Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), the Act will in truth, eliminate current regulatory and legal safeguards applied to vaccines.

What kind of profits need protecting? A good example is GlaxoSmithKline, which predicts that some of its new vaccines will become blockbusters with projected sales of more than $1 billion a year, according to Reuters on June 30, 2005. Glaxo aims to launch five major vaccines by 2010, it said.

Another example, for people who believe there’s no profit in vaccine making, “tell it to Wyeth, a big drug maker whose vaccine Prevnar ... costs more than $250 for the four-dose treatment given to infants,” says Kristine Severyn, PhD, author of the report, Profits, Not Science, Motivate Vaccine Mandates Vaccine Policy Institute.

Despite the price, "the government has recommended that all infants get the vaccine, and insurers generally pay for it - as does the federal Vaccines for Children program for low-income families. Prevnar, with sales expected to top $1 billion this year," says Severyn.

Severyn's predictions were right on. According to Wyeth's 2005 first quarter earnings report, Prevnar achieved net revenue of $391 million, more than double the first quarter earnings in 2004.

Bush’s FY2006 budget proposes to improve access to vaccines by allowing underinsured children to receive Vaccines for Children at state and local health clinics. The Department of Health and Human Services estimates that cost of the proposal will be $140 million in 2006, and $700 million over the 2006-2010 period.

How much does this sort of government protection cost? For starters, according to the Center for Public Integrity, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is the industry's trade organization and it has topped the list of pharmaceutical lobbying spending since 1998, shelling out $74 million. Its members include 16 of the industry's 20 largest companies and their subsidiaries and its current president is Billy Tauzin, is a former Republican congressman from Louisiana.

In the 2002 election cycle, PhRMA gave $3,505,052 with 95% going to Republicans. The top recipient in the Senate was none other than Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics. So far in the 2006 cycle, Gregg has received over $106,000 and Enzi has taken in $21,000 in pharma money.

Frist is a real piece of work. He has been trying to get a law passed to protect the drug companies for years. In 2002, he was behind the dead of night insertion of a provision into the Homeland Security bill that would have immunized vaccine makers from lawsuits related to thimerosal.

Frist has made millions upon millions profiting off human misery. The basis of the family fortune is the Hospital Corporation of America, the largest for-profit hospital conglomerate in the nation. However, the corporation also paid the largest health care settlement in history of more than $1.7 billion in civil and criminal penalties to settle charges of massive Medicare and Medicaid billing fraud.

Until recently, Frist and his wife owned $26 million worth of HCA stock. They are currently being investigated on charges of insider trading in the sale of HCA stock in the weeks immediately before the stock's value plummeted, and conflict of interest charges involving his ownership of HCA stock which he had previously claimed he knew nothing about because in accordance with ethics rules, it was in a "blind trust."

According to the Center for Justice and Democracy, Frist has received more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, raising more cash from health-care interests than 98% of his colleagues. In return, his legislative work in the Senate consists of almost nothing but trying to push through laws to increase profits for his number one backer.

Its worth noting that while Frist was its chairman, the pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee, doling out about $4 million, with Eli Lilly, the company that invented thimerosal, being the single biggest contributor, giving $1.6 million.

The National Vaccine Information Center (NVIC), a watchdog advocacy group, is highly critical of the pending protection legislation. According to the group's President, Barbara Loe Fisher, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades.” The NVIC calls the Act "a drug company stockholder's dream and a consumer's worst nightmare."

According to NVIC, currently there are at least ten different bills pending in Congress that will contain provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.

"This proposed legislation," Fisher told UPI, "is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur."

The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single authority for the advanced research and development of drugs and vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws. In addition, the Act specifically bars citizens from challenging the Secretary's rulings in court.

BARDA will be exempt from the Freedom of Information Act and the Federal Advisory Committee Act, to ensure that no evidence related to injuries caused by vaccines classified as "countermeasures" will become public.

"It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take," Fisher told UPI, "that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."

In a November 15, 2005, letter to Senator Burr's staff director, Fisher describes S 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.

“It is exactly this type of legislation that leads to civil disobedience and many times in the extreme form,” Dr Boyd Haley, a well-known expert on heavy metal toxicity, told this author, “I am very fearful of how certain segments of our society will respond to any mass vaccination program---especially if it does cause a problem like the thimerosal/autism situation,” he said.

As it stands today, if the Bush administration and its puppets in Congress achieve their common goal of protecting pharma profits by shielding vaccine makers from lawsuits, tax payers will have to foot the bill for the life-long costs of caring for millions of injured children.

Tax payers are already funding their special education needs. In a January 14, 2005, letter to a Congressional Subcommittee on Human Rights, the Government Accountability Office (GAO), informed committee members that the number of children diagnosed with autism served under the IDEA has increased by more than 500% in the last decade and that "about 1.5 million Americans are currently living with some form of autism."

In a recent interview with Teri Small published in the journal, Medical Veritas 2 (2005), Dr Geier said that he believes that this may be the greatest iatrogenic epidemic in history. "The damage already done to our society is already in the trillions of dollars," he warns. "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.

"All of us alive," Dr Geier says, "will have to bear its effects both in the lifetime care of the damaged children and the loss of what they otherwise might have contributed to our society."

Posted by MBVIC at 8:25 PM |

Public health concerns can trump individual rights


Public health concerns can trump individual rights, including certain expectations of privacy, freedom of movement and Fourth Amendment protections against unreasonable search and seizure.

By Rick Weiss
Washington Post Staff Writer

The federal Centers for Disease Control and Prevention released a phone-book-thick proposed rule yesterday that would give the federal government new powers to track the comings and goings of individual travelers and expand the circumstances under which passengers exposed to a serious communicable disease could be isolated or
quarantined.

The proposed changes are the latest in a series of preparatory moves aimed at solidifying federal health officials' legal authority to take actions aimed at slowing the spread of emerging contagious diseases, such as pandemic flu.

The new provisions -- the costs of which would fall mostly on the travel industry -- call for greater scrutiny of passengers for signs of illness and greater efforts by airlines and others to obtain personal contact information from travelers. They also broaden the list of symptoms that would make people subject to quarantine.

Although the rules strengthen federal authority to isolate passengers suspected of being infected, they also spell out in unprecedented detail key legal rights, including appeals processes, for citizens. The agency will accept public comment for 60 days before issuing a final regulation.

Officials said they are confident that the vast majority of Americans will support the changes so the government could better protect them from a major outbreak -- whether naturally occurring or from a bioterrorism attack.

"We're not talking about quarantining anybody for a sniffle or a cough," said Martin Cetron, director of the CDC's division of global migration and quarantine, in a conference call with reporters.

He added that although travelers would be asked to provide more personal information -- including phone numbers and e-mail addresses -- the goal is simply to be able to contact people if it becomes apparent they sat near an infected person while traveling.

"There are some very rigorous standards of privacy with which this information will be treated," Cetron said.

Many of the proposed changes are the result of lessons learned from the 2003 outbreak of SARS, or severe acute respiratory syndrome, when federal and international health officials realized how hard it was to track down passengers who had shared flights or other transportation with an individual who had the contagious disease.

Flight manifests are sometimes destroyed within days, they found, and customs documents -- being on paper -- were not easily transmitted to health authorities and were often illegible.

The proposed regulation requires airlines operating out of major airports and international cruise operators to request detailed contact information from passengers; maintain that information -- along with the passenger's seat location -- electronically for at least 60 days; and transmit it to the CDC within 12 hours of a
request.

As proposed, passengers could refuse to give personal contact information and still travel. The agency would destroy the information after a year, by which time it would no longer be useful for tracing disease.

The rule also demands that ship and airline captains report to the CDC any deaths or signs of significant illness on board, preferably before arriving at their destination. Existing requirements are less explicit and call for reporting to local health departments instead of federal officials.

The rule spells out a somewhat broadened array of circumstances or symptoms that can result in a passenger being held in quarantine or isolation upon arrival. (The term "quarantine" refers to the time a person is restricted because of suspicion of exposure to a disease but with no sign of illness; "isolation" refers to the time a person is restricted while ill and presumed able to spread the disease.) Practically speaking, the responsibility for detaining passengers falls largely on federal quarantine officers, who are eyeballing and questioning arriving passengers at a growing number of U.S. airports and other transport hubs.

Agency documents supporting the rule emphasize that the courts have long found that public health concerns can trump individual rights, including certain expectations of privacy, freedom of movement and Fourth Amendment protections against unreasonable search and seizure.

A yellow fever epidemic in 1796 prompted Congress to pass the first federal quarantine legislation, and provisions have expanded since then. The government can now quarantine people "reasonably expected to be infected with or exposed to" any of nine diseases: cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers (including Ebola), SARS and pandemic flu.

Under the new proposal, the criteria used to presume infection are broadened to include a fever of 100.4 degrees Fahrenheit or higher in conjunction with other symptoms, to make sure anyone with pandemic flu is included.

Although quarantine is generally seen as a last resort, the CDC documents state, it can be especially important in bioterrorism incidents in which the disease agent has been bioengineered to be especially contagious, drug-resistant or vaccine-resistant.

Federal courts have varied in their rulings on how long the government may hold someone before that person must be afforded an administrative hearing. The proposed rule would allow detention for three business days without a hearing, with an option to extend if medical tests confirm the need.

No one could be forcibly isolated for longer than the amount of time it takes for the suspected disease to be no longer communicable -- less than a month for most diseases.

The CDC estimated that the costs of implementing the new rule nationwide could be $185 million to $865 million per year. That would be a bargain, the agency calculated, given the potential direct and indirect costs of a major outbreak.

The proposed rule is to be published in the Federal Register today and can be viewed at http://www.cdc.gov/ncidod/dq.

Posted by MBVIC at 6:45 AM |

November 22, 2005

Ex - VA Researcher Sentenced in Drug Scandal


By THE ASSOCIATED PRESS

ALBANY, N.Y. (AP) -- A former cancer researcher at a Veterans Affairs hospital was sentenced Monday to nearly six years in prison for criminally negligent homicide in the death of an Air Force veteran enrolled in a drug experiment.

Paul Kornak admitted forging medical records at the Stratton Veterans Affairs Medical Center in 1999-2002 to make dozens of patients eligible to participate in drug studies. He also pleaded guilty to fraud and making a false statement.

In handing down the sentence, U.S. District Judge Frederick J. Scullin Jr. called Kornak ''callous and insensitive.''

Kornak, 54, said he was ''a broken man'' and apologized, but added that everything he did was ordered by the VA hospital's cancer program director.

The judge ordered him to pay almost $639,000 in restitution to two drug companies and the VA.

The homicide charge stemmed from the death of 71-year-old James DiGeorgio in 2001. He died a few weeks after participating in a drug-research program for stomach cancer.

The judge said that while it was not clear whether the experimental chemotherapy treatments caused or hastened the deaths of any patients, it was clear that they did not qualify for the experimental program and that Kornak doctored their records.

Kornak was indicted in 2003 on charges that included manslaughter and criminally negligent homicide. His arrest led to a nationwide investigation by the General Accounting Office that found inadequate policies and training to protect volunteers at VA research centers.

A month before DiGeorgio died, Kornak forged the test results of a blood sample provided by DiGeorgio so that he could qualify for the study even though he suffered from liver and kidney problems, federal prosecutor Grant Jaquith said.

Stratton earned thousands of dollars for each patient enrolled in drug trials.

Kornak was hired by Stratton in 1999 to coordinate clinical trials, even though he had served three years' probation for fraud in Pennsylvania for falsifying a medical license application. He acknowledged posing as a doctor though he never completed his training at a school on the Caribbean island of Grenada.

Kornak was fired in 2003 along with his boss, Dr. James Holland, a cancer specialist. Holland has not been charged. Jaquith would not comment on whether any charges would be filed.

Posted by MBVIC at 6:51 AM |

November 21, 2005

Anthrax Vaccine Possibly Linked to 21 Deaths


Global Security Newswire

The existing anthrax vaccine could be linked to 21 deaths and more than 4,100 illnesses, Newsday reported yesterday (see GSN, Nov. 2).

Experts also questioned whether the vaccine now being stockpiled or those being developed could protect people who inhale the pathogen during a terrorist attack.

BioPort Corp. has received orders worth nearly $250 million from the federal government for 10 million doses of its existing anthrax vaccine, while VaxGen Inc. of California is being paid at least $877 to produce 75 million doses of a new vaccine.

The Food and Drug Administration in December 2004 said that BioPort’s vaccine could be linked to 16 deaths. When questioned by Newsday, that number rose to 21.

The agency also noted 347 “serious” illnesses among the 4,100 adverse reactions possibly linked to the treatment since 1990.

The rate of serious illness linked to the anthrax vaccine is lower than those connected to treatments for smallpox, influenza and other diseases, according to the Food and Drug Administration.

“The vaccine is as safe as any,” said BioPort spokeswoman Kim Brennen Root.

The BioPort vaccine is known to protect against anthrax contracted through the skin, but its effectiveness against inhalational anthrax — the form most likely to be used in a large-scale terrorist incident — remains in question.

“The number of doses they are amassing is wildly out of proportion to any possible threat from anthrax,” said David Ozonoff, a professor at the Boston University School of Public Health. “What the benefits are is very unclear and there are always (health) risks … when you vaccinate a whole lot of people.”

The single significant study of the BioPort vaccine found that it had to be used along with antibiotics following inhalation to be effective in test animals, Newsday reported. VaxGen officials are so far unsure that their vaccine — now being tested on animals — could provide adequate, safe protection against aerosolized anthrax.

“We’d hopefully achieve a high level of protection, and the alternative is severe disease,” said Harry Keyserling, an Emory University School of Medicine pediatrics professor who was involved in early trials of the VaxGen vaccine.

A study led by the U.S. Army Medical Research Institute of Infectious Diseases in Maryland found the best results for treating monkeys exposed to anthrax came from using both the BioPort vaccine and antibiotics. All monkeys that received both treatments following exposure survived. Roughly 90 percent of monkeys survived if they received only the antibiotics, while only 20 percent of the monkeys that received only the vaccine lived.

The vaccine was “not meant to be given after exposure,” said lead study author Arthur Friedlander. “The vaccine alone doesn’t protect and we wouldn’t expect it to protect” those already infected with anthrax (Thomas Maier, Newsday, Nov. 20).

Posted by MBVIC at 3:21 PM |

Drugs firm stayed silent over its faulty vaccines


Note: This firm is making vaccines for the US to Stockpile.

Liverpool, UK
By Alan Weston Daily Post Staff

A DRUGS firm which employs around 600 people on Merseyside is embroiled in
fresh controversy after revelations that it stayed silent over thousands of
faulty vaccines.

PowderJect, run by multi-millionaire Labour donor and Government defence
minister Lord Drayson, knew for nearly two years that nine batches of
anti-TB jabs produced at its Liverpool factory had failed quality control
checks.

But the Speke-based company - now known by the name of new owners Chiron -
did not inform health regulators or the National Health Service, its main
customer.

Senior Labour backbencher Ian Gibson said: "We need a public inquiry into
this business. It doesn't smell as sweetly as it might."

But the Department of Health said a National Audit Office investigation had
already concluded the Government had acted correctly.

An investigation for the BBC's Money Programme found that internal tests at
the Liverpool vaccines plant revealed a problem with the vaccine's shelf
life from 1989 onwards, 11 years before Lord Drayson bought the factory.

But when PowderJect took over in October 2000, the company remained silent
about the failures and continued producing the BCG jab - at least one batch
of which also failed internal tests.

The firm finally had its licence to produce the vaccine suspended after an
inspection in July 2002 by the Medicines Control Agency, the Department of
Health body that monitors the effectiveness of medicines.

The problems are detailed in a report from the Medicines Control Agency (now
the Medicines and Healthcare Products Regulatory Authority) obtained under
the Freedom of Information Act.

"Since 1989, batches of BCG vaccine have been on a stability monitoring
programme of which nine have had sub-potent results at one or more time
points and had therefore failed to meet their end of shelf-life potency
criteria," it said.

"There is no evidence that failing stability (potency) reports have been
reported to the MCA."

The Department of Health has refused to say how many doses of the vaccine
might have been affected. The MHPRA said that the average batch size was
100,000, meaning 900,000 individual doses may have been involved.

In Ireland 15,000 children inoculated with the under-strength PowderJect
jabs were retested and 287, or 2%, revaccinated.

The Department of Health said that was not deemed necessary here.

"Revaccinating those who had already received the BCG vaccine could have
increased the likelihood of adverse reactions in some patients."

The Speke plant has only recently returned to flu jab production after a
contamination scare last year. It had its licence to manufacture the
Fluvirin vaccine suspended by the MHRA for three months, after it was
discovered 4m doses were contaminated with bacteria.

It is also ramping up the manufacture of treatment for a strain of bird flu
for America to stockpile.

The Department of Health has refused to say how many doses of the vaccine
might have been affected. The MHPRA said that the average batch size was
100,000, meaning 900,000 individual doses may have been involved.

In Ireland 15,000 children inoculated with the under-strength PowderJect
jabs were retested and 287, or 2%, revaccinated.

The Department of Health said that was not deemed necessary here.

"Revaccinating those who had already received the BCG vaccine could have
increased the likelihood of adverse reactions in some patients."

The Speke plant has only recently returned to flu jab production after a
contamination scare last year. It had its licence to manufacture the
Fluvirin vaccine suspended by the MHRA for three months, after it was
discovered 4m doses were contaminated with bacteria.

It is also ramping up the manufacture of treatment for a strain of bird flu
for America to stockpile.

It was announced earlier this month that the plant is set to change hands
again in a £3bn merger with Swiss drugs giant Novartis.

Novartis already owns 42% of California-based Chiron. A deal for the
outstanding 58% should be rubberstamped next year.

Posted by MBVIC at 6:28 AM |

November 20, 2005

A shot in the dark? - U.S. presses ahead with $1B plan to fight anthrax despite concerns about the Drugs' Cost and Safety


NEWSDAY
BY THOMAS MAIER, Researched by J. Stephen Smith

America's homeland defense program is spending more than $1 billion on
anthrax vaccines earmarked for wide civilian use despite uncertainty about
their effectiveness and an ongoing debate about potential health problems,
Newsday has found.

The vaccine stockpiling is a key element of the federal Project BioShield
program, which was awarded $5.6 billion in funding in 2004 to develop drugs
and vaccines to protect Americans against biological and chemical attacks.
It constitutes the largest federal effort ever to protect civilians from an
anthrax attack.

In May, BioPort Corp., the only manufacturer currently licensed in the
United States to produce an anthrax vaccine, won a $123-million contract to
make 5 million new doses for the public. And earlier this month, federal
officials doubled their request, saying they wanted to buy another 5 million
doses for approximately the same amount.

Last November, another firm, California-based VaxGen, received an
$877-million contract, plus up to $69 million in other potential fees, to
manufacture 75 million doses of an updated vaccine. The product, which still
lacks approval by the U.S. Food and Drug Administration, will not be
available until 2007, company officials say.

Federal officials say an airborne anthrax attack could kill thousands of
people in an urban setting like New York and tout the vaccines as key parts
of the civilian defense program.

But while a body of scientific research shows that the current vaccine is
effective if administered before skin exposure to anthrax - and the rate of
serious side effects is comparable to other common vaccines - several public
health experts have raised questions about the vaccine's safety and whether
it would work following an airborne attack.

David Ozonoff, a professor at Boston University's School of Public Health,
said there was "scant" evidence the vaccine will work to treat people who
inhale the airborne spores. He said studies show antibiotics as the most
effective treatment, and that the vaccine could cause potentially serious
health problems among civilians.

"The number of doses they are amassing is wildly out of proportion to any
possible threat from anthrax," Ozonoff said. "What the benefits are is very
unclear and there are always [health] risks ... when you vaccinate a whole
lot of people."

Hillel W. Cohen, an epidemiologist at the Albert Einstein College of
Medicine in the Bronx, agreed.

"The only possible benefit of a vaccine is if there's a danger of exposure
and that danger is small because of the technological hurdles of weaponizing
anthrax," Cohen said. " ... It's not something you can do in your basement."

If an anthrax attack were to occur today, the nation would rely on stocks of
the BioPort vaccine, which, like the VaxGen product, would be provided in
combination with antibiotics.

The only major study of the use of the BioPort vaccine following inhalation
exposure found it ineffective on laboratory animals unless used in
conjunction with antibiotics.

VaxGen also is conducting animal studies of its vaccine, but company
officials say they are not yet certain it will work safely and effectively
on humans exposed to airborne anthrax attacks.

"We'd hopefully achieve a high level of protection, and the alternative is
severe disease," said Harry Keyserling, a pediatrics professor at Emory
University School of Medicine in Atlanta and a key researcher in early
VaxGen trials.

Still, several prominent members of Congress are skeptical of the amount of
federal money going to VaxGen.

"I do question the BioShield acquisition strategy being pursued that bets
800 million dollars on an untested vaccine ... ," said Rep. Christopher
Shays (R-Conn.), chairman of the House Subcommittee on National Security,
Emerging Threats and International Relations.

"In the event of an attack, we need to know the vaccines and medicines in
the national stockpile are the best modern science can produce," Shays said.

The issue of whether the vaccines themselves may cause health problems, and
even death, also remains in dispute.

In documents of the FDA, Newsday found reports of more deaths and serious
health problems among anthrax vaccine takers than previously reported.

Until late last year, the FDA had listed reports of six deaths and 1,850
"adverse" reactions since 1990, ranging from minor redness at the
inoculation site to severe cardiovascular and respiratory system problems,
that "possibly" were caused by the BioPort vaccine. The government's
monitoring system collects voluntary reports of illness, but does not
determine exact causes.

But in a little-noticed report issued in December, the FDA said 16 deaths
were possibly linked to the BioPort vaccine. After Newsday asked about other
fatalities cited in FDA filings, the agency upped the total number of
fatalities possibly linked to the vaccine to 21 - including one the agency
said had been "incorrectly coded" in its database.

The same report tallied more than 4,100 illnesses, including 347 it
characterized as "serious," as possibly associated with the vaccine.

Government officials say the rate of serious illness associated with anthrax
injections is lower than that for other common vaccines such as influenza,
smallpox, tetanus, diphtheria and hepatitis.

About 9 percent of all health problems tied to the BioPort vaccine are
considered "serious," compared to 14 percent for the other vaccines
combined, said the FDA.

"This vaccine is as safe as any," said Kim Brennen Root, a spokeswoman for
BioPort, of Lansing, Mich.

Although humans can contract anthrax poisoning through breaks in the skin or
the gastrointestinal system, the civilian vaccine program is focused on
post-exposure treatment of the deadliest form, inhaled anthrax. Initial
symptoms of inhalation anthrax include mild fever and muscle aches, but
shock, severe breathing problems and often meningitis then develop,
according to the federal Centers for Disease Control and Prevention.

The BioPort vaccine contains proteins from the anthrax bacteria called
"protective antigen," and once in the bloodstream the vaccine makes the body
produce antibodies to the antigen, so the bacteria can't produce the anthrax
disease. The VaxGen product would work in a similar manner but with
technology utilizing new combinations of genetic material.

Under current plans, contaminated civilians, along with others who suspect
they were exposed, would be offered a regimen of antibiotics followed by
several injections of vaccine.

But while BioPort's FDA license authorizes the vaccine as a preventative
against anthrax contracted through skin exposure, federal officials have
begun efforts to expand that authorization to cover inhalation anthrax
suffered by civilians.

Under the expanded powers in Project BioShield, the BioPort vaccine could be
used following an airborne anthrax attack, even without a federal license
for that use. The VaxGen product also could be administered to civilians,
even if it were still unlicensed.

Federal officials say the catastrophic potential of an anthrax attack would
justify any available medical weapon.

"We know that the consequences of such use could be very grave," the
Department of Homeland Security said of the possibility of an anthrax
attack. But data about whether either of the vaccines would be effective in
treating inhalation anthrax victims are scarce.

As the primary evidence that its vaccine would work for post-exposure,
BioPort cited a 1993 study in the Journal of Infectious Diseases that was
sparked by concerns about anthrax attacks during the Persian Gulf War.

Tested on monkeys

The researchers, led by Arthur Friedlander of the Army Medical Research
Institute of Infectious Diseases at Fort Detrick in Frederick, Md., exposed
six groups of 10 Rhesus monkeys each to anthrax contained in a spray.
Subsequent treatment included the BioPort vaccine by itself, the vaccine in
combination with antibiotics or antibiotics alone. Members of a control
group received only saline.

The untreated monkeys had a death rate of 90 percent, while 80 percent of
the monkeys given only the anthrax vaccine died. The groups treated with the
antibiotics Ciprofloxacin or Doxycycline showed death rates of 11 percent
and 10 percent, respectively. Another group of animals took a combination of
Doxycycline and the vaccine. All survived.

"This suggests that antibiotic treatment, begun early after exposure,
prevented the infection from fully developing," the study said, adding that
the vaccine "may provide an additional degree of protection against relapse"
by killing spores remaining in the body after antibiotic treatment.

"We know that antibiotics treat the symptoms of anthrax, but antibiotics
don't kill the spores," said Root, the BioPort spokeswoman.

Beyond that, Friedlander said, the vaccine's effectiveness in treating
humans already exposed to anthrax spores remains uncertain.

The vaccine was "not meant to be given after exposure," Friedlander said in
an interview. "The vaccine alone doesn't protect and we wouldn't expect it
to protect" those contaminated with anthrax.

In touting their vaccine, VaxGen officials also note the limits of
antibiotics.

Lance Ignon, VaxGen's vice president of corporate affairs, noted CDC
recommendations that anthrax patients take antibiotics for only up to 60
days. He said patients often don't follow the prescribed schedule, while
others develop resistance to antibiotics over time or cannot tolerate them
long-term.

Beyond the unanswered questions about efficacy, there is debate about
whether the vaccines themselves are dangerous. Some activists and military
personnel argue that the government is moving too quickly with plans for a
civilian vaccination program, without assurances that the BioPort and VaxGen
vaccines won't cause serious health problems.

"There's been a tremendous amount of spin by the government," said Meryl
Nass, a physician in Maine and director of the Alliance for Human Research
Protection, an advocacy group that has been a long-time critic of the
anthrax vaccine program.

Several deaths reported

The BioPort vaccine was first licensed in 1970, primarily for use by
agricultural workers in danger of skin exposure to anthrax from animals. The
vaccine's health effects have been studied extensively in recent years,
beginning with the 1991 Gulf War when thousands of U.S. troops rolled up
their sleeves for injections.

Most studies have found low levels of serious illness, although allegations
of severe health problems, including several deaths, are detailed in at
least one federal report and in several lawsuits.

A 2002 study by the National Academies' Institute of Medicine examined the
cases of people who took a total of nearly 2 million doses of the vaccine,
primarily in the late 1990s.

Researchers pored over illness reports in examining possible patterns of
long-term health problems and gender differences in reactions to the
vaccine. They said "limited scientific data" suggested that the vaccine with
antibiotics "could provide post-exposure protection" from inhaled anthrax
spores. The vaccine, they said, was "sufficiently safe and effective."

In 2003, a study by academics from universities including George Washington
in Washington, D.C., and Johns Hopkins in Baltimore reviewed health problems
reported by some of the 500,000 military personnel who took the vaccine
between 1998 and 2001.

The lead researcher, John Sever of George Washington, said in an interview
that the inquiry could find no "unexpectedly high rate" of serious adverse
reaction to the vaccine. The study found six known deaths at that time were
either "unrelated" to the vaccine or "unclassifiable."

In 2002, however, a U.S. General Accounting Office study of Air National
Guard and Air Force Reserve members who took the vaccine revealed that 84 pe
rcent reported some adverse reaction - more than double the approximately 30
percent rate reported to the FDA and included in BioPort's packaging at the
time. The preponderance were minor, but almost 20 percent were considered
serious - chills, fever, nausea and dizziness, with some symptoms lasting
more than seven days, the GAO said.

"The implications were that the vaccine was part of the problem of getting
sick, and we recommended that they should be following up," said Nancy
Kingsbury, who oversaw the GAO study.

The Army rejected the GAO's call for more active surveillance, saying it
already kept track of and studied health problems linked to anthrax
vaccinations.

Defense Department records show that Army Reservist Spc. Rachel Lacy took
vaccinations for anthrax and smallpox at Fort McCoy in Wisconsin, while
preparing in March 2003 for overseas deployment. Subsequently, Lacy
developed pulmonary and neurological problems that led to inflammation of
her lungs. She died the following month.

Lacy's father, Moses, said he believes the combination of vaccinations
overwhelmed his daughter. "I do think the anthrax vaccine contributed to my
daughter's death," he said.

After reviewing Lacy's case, two federal panels said the evidence "favored a
causal relationship" between her death and the vaccines, although they could
not establish a conclusive link.

Root, the BioPort spokeswoman, denied any link between Lacy's death and the
vaccine.

Other U.S. service members have cited the vaccine's alleged ill effects in
lawsuits challenging the military's compulsory use of the BioPort vaccine.
Hundreds of troops have refused to undergo the vaccine regimen, and some
have faced court-martial.

Three advocacy groups have filed court papers contending that the FDA
improperly granted "emergency authorization" for the military to use the
vaccine against possible airborne anthrax attacks, and ignored evidence it
was unsafe.

Last year, U.S. District Judge Emmet Sullivan, of Washington, D.C.,
temporarily halted the military program, questioning the FDA's approval of
the vaccine for inhalation anthrax cases. Sullivan later allowed the revival
of the inoculation program, after the military made it voluntary.

Some health problems, including headaches and fatigue, also have cropped up
in early trials of the VaxGen vaccine, company officials said. However,
VaxGen chief executive Lance Gordon called the reported health problems "not
significant" because of the small initial testing sample.

But BioPort's vice president of medical affairs, Tom Waytes, emphasized
VaxGen's early difficulties and said it was time for them "to go back to the
drawing board."

Despite the safety debate, BioPort and VaxGen continue to vie for the $5.6
billion in Project BioShield money.

This year, BioPort said it has used Jerome Hauer, former acting assistant
secretary of the HHS Office of Public Health and Emergency Preparedness, as
a lobbyist in Washington.

Last year, BioPort hired Louis Sullivan, the former HHS secretary under
President George H.W. Bush, as a consultant to help land a new federal
contract for its anthrax vaccine.

Sullivan said he set up a meeting for the company with government scientists
in October 2004. The following month, BioPort announced it would be
manufacturing 5 million anthrax vaccine doses for the civilian stockpile.

How the vaccine works: In general, the anthrax vaccine works the same way as
tetanus, rabies and other inoculations.

(A) A vaccine is made from an antigen isolated or produced from the
disease-causing organism. In the case of anthrax, the existing vaccine is
culled from proteins in the bacteria and (B) injected into the bloodstream.
(C) Once it recognizes the antigen, T cells in the immune system trigger B
cells to neutralize it and another type of T cells to kill it.

The process produces memory cells that remain ready to mount a quick
response against subsequent infection from the same agent. That's why, for
example, a childhood vaccination generally protects against a disease for a
lifetime.

How it's taken

As a preventative, it is taken in six does of 0.5 milliliters each over an
18-month period. For those already exposed, treatment is antibiotics with
three doses of vaccine.

Side effects

Mild: Soreness, muscle and joint aches, headaches, chills, fever, fatigue
and nausea.

Severe: May range from serious allergic reaction to rarely, death.

Anthrax, in brief

Anthrax spores exist all over the world and become dangerous only when they
make contact with human blood, organs and tissues. There are three types of
anthrax exposure:

1: CUTANEOUS

· Bacteria enter through a break in the skin.

· Handling contaminated animal products, such as meat, wool or hides.

Death is rare if antibiotic therapy is given.

2: GASTROINTESTINAL

· Eating raw, undercooked, contaminated meat.*

Death in 25% to 60% of cases.

3: INHALATIONAL

· Inhaling at least a deep breath of anthrax spores.

If left untreated, death rate is almost 100%; even when treated, 45% to 80%
of patient's die.

1.3 million Number of military personnel who have taken vaccines for anthrax
since 1990

5 million+ Number of individual doses supplied since 1990

$123 million Amount BioPort Corp. of Lansing, Mich., is being paid to make 5
million new doses of its vaccine.

$877 million+ Amount VaxGen, Inc., of Brisbane, Calif., is being paid to
develop 75 million doses of an updated vaccine.

SOURCES: National Health Museum, Department of Defense, Centers for Disease
Control and Prevention, Food and Drug Administration, Anthrax Vaccine
Immunization Program

Posted by MBVIC at 6:26 AM |

November 19, 2005

U.S. Senate Committee Approves Vaccine Promotion Legislation


By David Ruppe
Global Security Newswire

WASHINGTON - A key Senate committee yesterday approved legislation that would create a new agency to direct government biological defense research and provide several new types of incentives that proponents say would encourage more private sector investment into countermeasure production (see GSN, Oct. 17).

The Health, Education, Labor and Pensions Committee approved by voice vote the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 despite Democratic objections. A Senate floor vote could come next week. There is no such legislation in the House.

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," the legislation's author, Senator Richard Burr (R-N.C.), said in a statement after the vote.

Enacting the bill would mean "that we as a nation are prepared for a variety of threats that include natural, deliberate and accidental threats," said committee Chairman Mike Enzi (R-Wyo.).

The bill is intended to add incentives beyond those approved in the "Project Bioshield" law passed last year, which was designed to encourage the private sector to invest in drug and vaccine production where the U.S. government would probably be the only buyer. Burr and others have said the law did not go far enough to encourage private sector investment.

Burr, who chairs the committee's Bioterrorism and Public Health Preparedness Subcommittee, said potential liability exposure and other factors have left companies reluctant to invest in new biodefense and flu countermeasures.

Critics say the new bill would do nothing to address the potential near-term threat of a deadly avian flu outbreak and that its provisions could drive up the cost of certain drugs and vaccines and greatly reduce the public's legal recourse for defective products.

"I hope . that people don't think that this is going to solve the problem of the possible avian flu pandemic that is on our doorstep," Senator Tom Harkin (D-Iowa) said.

New Agency, Industry Incentives

The bill specifically would create a "Biomedical Advanced Research and Development Agency" within the Health and Human Services Department.

The new agency would act "as the single point of authority" within the federal government for research and development of medical countermeasures against bioterrorism and natural disease outbreaks.

Burr's legislation would also provide incentives that proponents said are needed to encourage the biotech and pharmaceutical industries to invest more for drugs and vaccines for biological defense and naturally occurring disease protections.

For instance, the bill would allow Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product. It would forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures.

The bill would also provide companies with liability protections for new countermeasures not yet licensed by the Food and Drug Administration, so that a company producing products for epidemics or biodefense could only be sued if the Health and Human Services secretary finds clear and convincing evidence it willfully engaged in misconduct that caused the injury.

The bill would provide rebates or grants to encourage companies to manufacture vaccines, medical countermeasures, and pandemic or epidemic products within the United States and would allow the government to help pay the costs of establishing domestic manufacturing facilities.

Burr's proposal would provide a "limited antitrust exemption" for the Health and Human Services secretary and the BARDA director that would allow them to collaborate and consult with industry on developing new countermeasures.

It also would exempt the new agency from standard Freedom of Information Act and Federal Advisory Committee Act requirements for public transparency and would exempt certain federal cost oversight requirements.

Less controversially, the bill also would compensate first responders for countermeasures they purchase and would provide money to encourage development of animal models on which countermeasures could be tested against diseases too dangerous to test on humans.

Doesn't Address Flu Threat, Democrats Say

Committee Democrats said they support the general aims of the bill and many of its provisions, including creating the new agency.

Democrats said, though, that the bill - targeted at longer-term research and development - does little to improve the country's near-term preparedness for responding to an avian flu outbreak. That would include funding the stockpile of antibiotic drugs and improving the public health infrastructure and surge capacity.

"Congress may wait for regular ordeals to deal with the pandemic flu, but the flu virus will not wait while we delay," said Senator Edward Kennedy (D-Mass.).

"We need the capacity to develop the vaccines now. We need to appropriate money now," Harkin said. "We need emergency funding right now, probably to the tune of several billion dollars to begin to get grants out there right now . to build the vaccine manufacturing facilities for flu vaccines. . We need to get these facilities built in the next six or seven months."

Burr said including such provisions in the bill would have greatly delayed the measure. He said there is "ample time" to prepare such legislation and that the committee would soon begin work on it for passage next year.

Other Objections

Democrats said they also objected to how the liability provisions were written. Company liability protections should only apply when a product is used in an emergency, and not for other situations, Harkin said.

Kennedy said the liability protections should be accompanied by a "strong [federal] compensation program" in the bill, because "the rules should not be stacked against patients."

Senator Hillary Clinton (D-N.Y.) criticized the market exclusivity provision for preventing public sale of generic versions of new drugs and vaccines for use as countermeasures against dangerous diseases.

Clinton praised the proposed agency creation as "a good idea," but asked how it, as a coordinating agency, would "have more direct control than all the other coordinating positions have had."

Chairman Enzi said the committee would try to address Democrats' concerns by possibly amending the bill, but said mutually agreed upon changes would be made by Thursday at the latest.

There remain "fundamental differences" between Republicans and Democrats "that we have to work out," Burr said.

Democrats said they might seek to amend the bill on the Senate floor.

Some nongovernmental organizations have taken a harsher view of the bill's implications than the committee Democrats.

It "basically eradicates regulatory safeguards against the production of unsafe vaccines, drugs and devices that the government determines to be for pandemic, epidemic or bioterrorism/security countermeasure use, and then wipes out liability for any drug company or health care provider that makes or dispenses them," the Center for Justice and Democracy in New York said in a recent press release.

As a result of the liability provision, the advocacy group said, families or victims of defective countermeasures could "have no recourse, no ability to file a claim or lawsuit, no way to collect any compensation even if the drug company or health care provider was negligent, reckless or in some cases intentionally harmful."

Posted by MBVIC at 7:16 AM |

November 18, 2005

Key Official Lacks Authority to Lead U.S. Response to Biological Attack or Other Crises, Experts Warn


Global Security Newswire

Homeland security experts have warned that the U.S. Homeland Security Department’s chief medical officer lacks the necessary authority to prepare the United States for a bioterror incident or other health crisis, the Federal Times reported today (see GSN, Oct. 28).

Jeffrey Runge took the new position in July. Experts warned Congress last month that Runge’s role poorly defined and that he does not have enough power.

The chief medical officer must lead the federal medical response to a bioterrorism attack, disease outbreak or natural disaster, Jeffrey Lowell, who advised former Homeland Security Secretary Tom Ridge on medical issues, said during an Oct. 27 congressional hearing. However, the position now lacks the authority to direct such a response, Lowell said.

Lowell told the House Homeland Security Management, Integration and Oversight Subcommittee that it is unclear who would direct the medical response if a catastrophic event occurs.

Subcommittee Chairman Mike Rogers (R-Ala.) said that one individual must be designated to lead the medical response. If it is not the chief medical officer, another officer should be appointed.

“I don’t want there to be any shucking and jiving down the road, and have people say, ‘It was his responsibility,’” Rogers said. He noted that he was not criticizing Runge or Homeland Security Secretary Michael Chertoff, but that the position needs to be improved.

The medical officer should develop and implement a national plan against bioterrorism, said David Heyman, a senior fellow at the Center for Strategic and International Studies. The officer must also work to increase hospitals’ ability to take in more patients during a crisis, he said.

Lowell added that the Homeland Security Department should set standards for mobile medical facilities that could handle overflow patients during an emergency (Stephen Losey, Federal Times, Nov. 18).

Posted by MBVIC at 6:52 AM |

November 17, 2005

Vaccine Funding Tied to Liability - Trial Lawyers Say Move Would Hurt Consumers


By Jeffrey H. Birnbaum
Washington Post Staff Writer

Legislation that would pour billions of dollars into the production of vaccines against avian flu and other pandemic diseases is threatened by the trial lawyers' lobby, which objects to proposed limits onlawsuits against drug manufacturers.

Republican congressional leaders, acting at the urging of President Bush, hope to approve a measure soon that would appropriate about $7 billion to pay for vaccines that would combat a flu epidemic and biological attacks by terrorists. The bill could begin moving on Capitol Hill this week.

But the Association of Trial Lawyers of America and some of its Democratic allies in Congress are working to scuttle or drastically transform the effort, asserting that anti-lawsuit language in the bill would so broadly indemnify pharmaceutical companies against suits that consumers' rights would be denied.

Sen. Judd Gregg (R-N.H.), the Senate's chief advocate for strict liability protections, asserted that the companies need to be thoroughly indemnified against suits to provide enough of an incentive for them to make vaccines, which tend to be low-profit products.

The conflict will almost certainly lead to fireworks during debate on the floor of the House and the Senate and could delay the legislation itself, which is a Bush priority, lobbyists and congressional aides said.

"A slowdown is possible," said Amy Call, a spokeswoman for Senate Majority Leader Bill Frist (R-Tenn.), who supports strict lawsuit limitations. "That's the way the place works."

Neither side appears willing to bend, and negotiations about the provision lately have been among Republicans only. Democrats are complaining bitterly about being cut out of the process and are working hard to stop the measure.

"The Republican leadership in Congress is trying to do another special favor for drug companies by slipping a provision into a massive spending bill to absolve the pharmaceutical industry of any responsibility to patients injured by dangerous drugs or vaccines," Sen. Edward M. Kennedy (D-Mass.) said. "It's cynical to claim that this is what's needed to deal with avian flu."

Sen. Christopher J. Dodd (D-Conn.) said: "We all share the goal of protecting the American people. But I'm alarmed that such a critical question . . . is being handled with a backroom deal."

He and Kennedy also said people might refuse to take a vaccine without an effective compensation program for people who get injured. They asserted that the Republican provision does not contain an adequate plan to compensate such people.

ATLA and its Democratic supporters believe that the pending provision, drafts of which have been circulating informally on Capitol Hill, would stop a wide variety of lawsuits against drugmakers, including those that target drugs other than vaccines. The lobby has long fought such broad restrictions.

Republicans deny that the provision is that far-reaching. But they are also determined to press on with a tough liability provision that the trial lawyers would almost certainly reject. Republican lawmakers and pharmaceutical representatives contend that without strong limits on lawsuits, drug companies will not produce the vaccines.

"You're not going to get vaccine production in the U.S. unless you have liability protection," Gregg said in a telephone interview. "The risk of a major liability suit far outweighs the potential rate of return that you'd get on the investment."

The drug companies, some of which have been working closely with Gregg on the legislation, agreed. "Full liability protection is a requirement for our participation in the development and production of a pandemic vaccine," said Len Lavenda, spokesman for Sanofi Pasteur, the vaccine-making unit of Sanofi-Aventis Group.

Republicans, who are still devising the legislation's liability section, also accuse Democrats of playing politics with public health. "Democrats in the past have always stood up with the trial lawyers," said Call, Frist's spokeswoman. "We'll see if they stand up for them or for the American people."

Contrary to ATLA's assertions, Call said the wording under discussion would affect only companies that manufacture vaccines that counter pandemics officially declared national emergencies.

If the secretary of health and human services certifies such a disaster, she said, patient lawsuits would be restricted to those that claim the companies willfully engaged in misconduct. Lesser allegations would be disallowed as a reason to sue, she said.

ATLA and Republican lawmakers have been sparring for months over how best to deal with lawsuits against vaccine producers. ATLA and its Democratic backers have wanted the language to be narrowly drawn; Republican leaders and pharmaceutical firms have been pushing for wider restrictions.

Republican leaders are considering attaching the latest pandemic provision to any of a several appropriations bills that constitute "must pass" legislation this year. Their options include bills that fund the Department of Health and Human Services and the Department of Defense, staffers said.

Posted by MBVIC at 6:41 AM |

Senators Say GOP Seeks To Shield Drug Makers - Dodd, Kennedy See Legal Relief Threat


By THOMAS D. WILLIAMS
Courant Staff Writer

Two Democratic U.S. senators on Wednesday accused GOP senators of trying to slip through a measure that would shield the makers of experimental drugs authorized for use in national health emergencies from being sued even if such drugs prove harmful.

The senators, Christopher Dodd, D-Conn., and Edward M. Kennedy, D-Mass., said powerful legal immunities being pushed by the GOP would deny people legal recourse for injuries or deaths arising from the use of such drugs.

Amy Call, a spokesperson for Senate Majority Leader Bill Frist, R-Tenn, said much of the language in the measure has been discussed in the Senate Committee on Health, Education, Labor & Pensions, of which Kennedy is a ranking member and Dodd is a member.

"If Sens. Dodd and Kennedy would like to come to the table in a good faith way, Sen. Frist would be happy to talk to them," Call said. "This is important legislation to ensure that if a pandemic-like avian flu hits, the vaccine makers will be available to manufacture the protections the American people will need."

Call said the provision would probably be attached to another bill in the next two weeks or more.

But, Dodd said this provision "is being discussed in a backdoor deal without including a [consumer] compensation program and discussing [drug] liability issues."

He said both he and Kennedy strongly supported encouraging manufacturers creating drugs to protect the public in a national emergency, but not without protections.

During a conference telephone call with the press and Dodd, Kennedy said similar issues arose during the smallpox vaccine debate.

In that case, many medical emergency responders were unwilling to take the vaccine, fearing they would be unable to seek compensation in the event of an adverse reaction.

"They are going out and taking the risk in a national emergency," said Kennedy. "If we are asking them to act in the national interest, they need compensation [protection]."

However, Doug Heye, a spokesman for U.S. Sen. Richard Burr, R-N.C., said the bill includes a compensation program.

"The legislation specifically requires the secretary of [Health and Human Services] to put in place a compensation program," Heye said. "There are [freedom of information] exemptions for proprietary and national security information."

Call said the provision would not shield manufactures for "willful misconduct."

Posted by MBVIC at 6:40 AM |

November 16, 2005

At FDA, Graham is still the whistle-blower


USA TODAY
By Rita Rubin,

OLNEY, Md. - As David Graham sipped a large decaf skim mocha - hold the foam and whipped cream - at a suburban Washington, D.C., coffee shop last week, a fellow customer, a stranger, walked over and wished him well. David Graham isn't satisfied with the agency's progress on drug safety.

It was a year ago Friday that Graham made headlines by blowing the whistle on the Food and Drug Administration at a Senate committee hearing. But he's still sometimes recognized by fans. (Related story:Graham's least-favored drugs)

They'll be happy to know that he's still associate director for science and medicine in the FDA's Office of Drug Safety, which - much to his dismay - is still part of the FDA center that reviews and approves new drugs.

But they may not be thrilled to hear what he has to say about what has changed - or, more accurately, what has not changed - since he told the Senate Finance Committee the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure" like Vioxx. Merck pulled the blockbuster arthritis drug off the market in September 2004 because it raises heart attack and stroke risk.

"Today, the United States of America is worse off when it comes to drug safety than it was a year ago when I testified," Graham says. That's because the FDA's recent drug safety initiatives serve only as window dressing, diverting attention away from real solutions, such as an independent Office of Drug Safety, Graham says.

Take the Drug Safety Oversight Board established by the FDA in February to oversee management of drug safety issues. "A kangaroo court," Graham says, noting that several of the 15 members are FDA employees who work for the center that reviews and approves new drugs.

Or take the ongoing Institute of Medicine study of drug safety requested by the FDA. Graham says he doubts the study will make much of a difference, because it's based largely on information supplied by the FDA.

Senate Finance Committee chair Chuck Grassley, R-Iowa, who convened the November 2004 hearing, says Graham should not be discouraged. "Dr. Graham and people like him make a big difference," Grassley says.

Because of Graham's coming forward, Grassley says, his staff talks to several FDA whistle-blowers - some new, some not - every week.

Neither Acting FDA Commissioner Andrew von Eschenbach nor Steven Galson, director of the FDA's Center for Drug Evaluation and Research, agreed to be interviewed for this story.

Instead, Susan Bro, senior communications adviser in the FDA commissioner's office, responded via e-mail:

"Who's the 'we' behind the FDA? Thousands of cutting-edge scientists, physicians, pharmacists and public health experts who consult with their colleagues and outside experts to make sound medical decisions and recommendations each and every day. To characterize the work being done here as anything less than substantial, forward-looking and ambitious is simply not accurate."

An article in this week's Journal of the American Medical Association supports Graham's assessment of the FDA. Especially in the past five years, writes Howard Markel, a University of Michigan pediatrician and history of medicine professor, the FDA has been heading downward "from a sterling - albeit very human - regulatory agency into one much more tarnished, politicized, and increasingly disputed by the very people it was designed to protect."

Drugs non-grata
By Rita Rubin, USA TODAY

At a Senate hearing a year ago, FDA whistle-blower David Graham named five drugs he felt posed serious safety concerns:

Accutane

Graham called this acne drug a "regulatory failure" because the FDA had not done enough to ensure that pregnant women, in whom it can cause serious fetal abnormalities, not take it. Less than a week later, the FDA announced plans to strengthen such efforts.

Bextra

Pfizer stopped selling Bextra, a cousin of Vioxx and Celebrex, on April 7. The FDA said it wanted Bextra withdrawn because it was no better than Celebrex and was more likely to cause a deadly skin reaction. Graham says the FDA knew this before approval.

Crestor

Graham said Crestor is the only cholesterol-lowering drug that causes acute kidney failure. "I think Crestor should be a second-line drug," Graham says. Maker AstraZeneca reported Tuesday at a scientific meeting that Crestor, alone or with cholesterol drug Zetia, is "an important and effective treatment option" for severe high cholesterol.

Meridia

Graham said this weight-loss drug can cause high blood pressure. But in August, the FDA denied a petition from consumer advocacy group Public Citizen to withdraw it. The agency said Meridia's benefits outweigh its risks.

Serevent

An FDA advisory committee in July recommended that Serevent and two other asthma drugs stay on the market. But the panel urged more research to see whether the drugs might worsen asthma in some.

In an interview last week, Graham talked about a new set of drugs he's concerned about:

Atypical anti-psychotics

Risperidone, or Risperdal, is the oldest and likely best known of the drugs approved to treat schizophrenia. But they're widely used off-label for behavioral problems in elderly dementia patients.

In April, the FDA warned that off-label use has been linked to a higher death risk, and it asked makers to add to their labels a black-box warning noting the risk and that treating behavioral problems in dementia patients is an unapproved use.

"FDA has known about this for two or three years," Graham says, figuring that off-label use may cause up to 62,000 excess deaths a year. "What does FDA do? It tinkers with the label."

Natrecor

In 2001, the FDA followed its advisory panel's advice and approved Natrecor to treat hospitalized heart failure patients.

Graham cites a July New England Journal of Medicine article by Eric Topol of the Cleveland Clinic that questions whether the drug should stay on the market, given that no trial has yet proved that it reduces the risk of death or repeated hospitalization from heart failure. Last month, maker Scios posted a letter on its site saying Natrecor is safe and effective when used in hospitalized heart failure patients.

Pargluva

Unlike other drugs that concern Graham, this type 2 diabetes pill isn't yet on the market, but he cites its recent history as another example of FDA laxity on safety. An advisory panel Sept. 9 voted 8-1 in favor of approval. Collaborators Bristol-Myers Squibb and Merck said Oct. 18 they'd received an "approvable letter" from the FDA that it would OK Pargluva once questions about ongoing and finished studies were answered.

But on Oct. 20, The Journal of the American Medical Association website posted a critical analysis of the same data reviewed by FDA staff and the advisory panel. Compared with a placebo or the diabetes drug Actos, Pargluva raised the risk of death, heart attack, stroke and congestive heart failure, the authors wrote.

On Oct. 27, Bristol-Myers said it might do more studies, or it might just stop developing Pargluva.

Posted by MBVIC at 7:01 AM |

Frist Inoculates Drug Makers for Any Vaccine Liability After Industry Won Him Senate & He Himself Said Anthrax Was Problematic


To: National Desk
Contact: Jamie Court, 310-874-9989; Carmen Balber, 310-392-0522 ext 324

SANTA MONICA, Calif., Nov. 16 /U.S. Newswire/ -- Senate Majority Leader Bill Frist is seeking a last-minute amendment to an appropriations bill that would remove legal liability from a drug company if the Bush Administration declares its vaccines are needed to respond to a public health threat. The Associated Press reports Frist is behind the eleventh-hour change.

The pharmaceutical industry that makes the vaccines was the largest industry donor to Frist's National Republican Senatorial Committee, the political arm of Senate Republicans that was key to winning a GOP majority in the Senate. The Foundation for Taxpayer and Consumer Rights (FTCR) called on Frist to withdraw the amendment based on his own conflict of interest - the industry he is helping is his biggest donor and he has himself condemned the safety of the anthrax vaccine.

"How can we trust an administration that does not know what a weapon of mass destruction is to take away our legal rights when it sees a so-called public health threat?" said Jamie Court of the Foundation for Taxpayer and Consumer Rights. "This is a total giveaway to the GOP's biggest donor using national security as cover. It's a terror dividend for Big Pharma, which handed Senator Frist and the GOP the third branch of government."

Under the legislation the Frist amendment is based on, the Bush Administration could declare a real or potential public health emergency, classify any vaccine or product as necessary to respond to a public health threat and provide its manufacturer almost virtual immunity from prosecution. The immunity provisions are so broad that any product that can be considered a "countermeasure," not just vaccines, would be included under its protection.

Frist himself has acknowledged problems with the anthrax vaccine: "The (anthrax) vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that."

"I do not recommend widespread inoculation for people with the vaccine in the Hart Building," Frist said. "There are too many side effects and if there is limited chance of exposure the side effects would far outweigh any potential advantage." (CNN.com, 12/20/01, http://archives.cnn.com/2001/US/12/18/anthrax/ )

After a secret attempt to provide liability protection for the makers of Thimerosal in 2002 under the cover of an amendment to Homeland Security legislation, Congressional leaders are again promoting sweeping protections for the drug industry while no one is looking. Frist denied involvement in the Thimerosol amendment in 2002 but the backlash forced the Senate to remove the immunity provision. The 2002 amendment was based on parallel legislation Frist carried.

Frist's blind trust listed personal investments with Abbot Labs and Johnson & Johnson, each in the $15,000 to $50,000 range, through 2004. Frist himself had a close relationship with Eli Lilly, maker of Thimerosal, which not only topped the list of drug maker contributors to the Senator's PAC but also bought 5,000 copies of Frist's book on bio-terrorrism.

FTCR filed an ethics complaint with the Senate Select Ethics Committee last April charging Senate Majority Leader Frist (R-TN) with a conflict of interest for promoting medical malpractice liability limits while retaining stock worth millions in HCA. The Frist family-founded hospital chain owns HCI, the nation's fourth largest malpractice insurer. The committee dismissed the complaint, ruling that Frist's millions did not constitute a conflict. The Senator sold the stock this summer just before the stock price plummeted and is under investigation by the SEC for possible insider trading.

For more on FTCR's complaints about Senator Frist's ethics, visit http://www.consumerwatchdog.org/corporate/Frist/

Posted by MBVIC at 6:59 AM |

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