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Jalapenos, the Real Culprit?
It’s been nearly three months since the first of more than 900 people fell ill with salmonella poisoning in the outbreak that the Food and Drug Admin. has linked to tomatoes. Now, it seems likely that it wasn’t tomatoes that done it. But, it could be the jalapenos.
“Unfortunately, I’m becoming increasingly confident in saying this outbreak is going to end up being one in which the initial data got the regulatory folks going down the wrong path,” said Dr. Tim Jones, the state epidemiologist of Tennessee, which has had a handful of cases linked to the outbreak. “There’s a decent chance it’s not tomatoes at all.”
Illustration by: Matt Mahurin
At a news conference last week, officials from the Food and Drug Admin. and Centers for Disease Control said they were expanding the probe beyond tomatoes, “to include items that are eaten with tomatoes.” When asked if, in other words, the culprit might not be tomatoes, CDC spokeswoman Lola Russell demurred. “We’re not saying that.” She added, “It would be premature to list any other particular food item.”
FDA officials hinted strongly that some other component of salsa might be the source of the bacteria. If that’s the case, it could well be jalapenos, which are stored and kept long enough to keep infecting people for months. Tomatoes — and for that matter, cilantro — are usually thrown away within a few weeks. The Wall Street Journal had some of the story here and NPR followed up here.
Federal warnings about tomatoes have cost the food industry upward of $250 million thus far, so it isn’t surprising that CDC isn’t eager to point fingers at another vegetable. Restaurant owners, tomato growers and packers are up in arms over this drubbing. “They killed an industry,” said Batista Madonia, president of East Coast Brokers and Packers, a major tomato grower based in northern Florida. “My business is off 75 percent, and who knows if it will recover. Look at the spinach thing. It ended a year ago. But whenever I eat spinach, there’s still something in the back of my mind that says it’s dangerous.”
Many have complained about the FDA’s lack of transparency, and fault officials for failing to consult industry and academic experts. FDA and CDC needed to publicize more of their data during such investigations, and “take advantage of outside expertise that could speed these investigations,” said Roberta Cook, a tomato marketing expert at the University of California-Davis. “These things are important for protection of public health — and to avoid devastating entire commodity industries for no reason.”
“So little information is being released by FDA,” said Tony Dimare of Dimare Fresh, a major Florida-based tomato producer, “that you, me, no one outside of the inner circle of FDA, knows what’s going on. Meanwhile, in Florida, we’ve been tainted, thrown under the bus and guilty by association for being in production at the time of the outbreak. My fear is if the investigation lingers long enough, it’ll affect the start of the next Florida season, in September. This thing is just a total blunder by FDA.”
CDC and FDA haven’t disclosed the data they’re looking at, but state epidemiologists I spoke with say that most of the cases — by no means all — have been traced to Mexican restaurants, where salsa and chips flow freely. In addition, most of the evidence points to Mexican crops.
Tracking a disease involves a laborious, time-consuming culturing and typing of the bacteria, followed by interviews in which sick or recovered patients are asked to remember what they ate two weeks earlier. This may be where federal investigators got off on the wrong foot.
The first investigations were done in New Mexico, where people on Navajo reservations got sick. Most remembered eating tomatoes, but it’s possible that state public health officials narrowed the target too soon. This mistake — if it turns out to have been a mistake — was passed along to the CDC. It then designed questionnaires for those sickened with Salmonella saintpaul based on the premise that it came from tomatoes — not what the tomatoes were eaten with.
Epidemiologists at CDC and state public health agencies frequently express impatience with the length of time it takes the FDA to do trace-backs, and the agency’s close-to-the-vest style when carrying out such investigations. But in this case, epidemiologists may have led FDA down the wrong path.
“Trace-backs are hard enough,” said Jones, of Tennessee, “They are virtually impossible if things aren’t narrowed down accurately at the beginning.”
The longer the investigation goes on, the more likely it is to turn up red herrings. There is probably always a low-level background rate of Salmonella saintpaul poisoning in the U.S. — cases that may be being counted now as part of the outbreak. Another confounder, in a long outbreak, is secondary cases spread by someone already sickened with the disease.
“Let’s say you trace a couple cases to an Italian restaurant,” said Jones. “But maybe the waiter ate salsa at a Mexican place a few days earlier, then stayed on the job because he didn’t feel that sick.”
Last week, the CDC quietly revised the questionnaire that state health officials are using in the salmonella investigation to include other foods — particularly those served in tomato-based salsa and pico de gallo.
Jones suspects — he calls it nothing more than a hunch — that peppers are the most likely culprit. The outbreak has gone on nearly three months — far longer than any one batch of tomatoes would be on the market, especially since most restaurants and stores ditched tomatoes that were for sale when the FDA first announced the outbreak. New Mexico health officials have repeatedly cultured tomatoes eaten by sick citizens there, but they have been unable to culture Salmonella saintpaul.
The outbreak hasn’t been linked to any particular chain — which bolsters the idea that it was a fresh produce item, rather than a finished product, that is responsible. And trace-backs to Mexican and Florida tomato operations appear not to have found any evidence. Adding this up points the finger to jalapenos. Maybe.
“Tomatoes and cilantro go bad pretty quick. But I can keep jalapenos in my fridge a month and a half and they’re still edible, said Jones, “So that floats higher on my list.”
When asked for comment, FDA spokeswoman Kimberly Rawlings referred this reporter to the FDA Website.
In the climate of budget-cutting and politicization that has characterized the federal bureaucracy under President George W. Bush, many are eager to point the finger of blame at the White House. But, so far at least, there’s no evidence that the investigation’s troubles have anything to do with politics.
Investigating food-based disease outbreaks is difficult. Produce isn’t generally labeled or tracked from the field to the store or restaurant. And tomatoes take a particularly circuitous route to market. They often go from farm to packing house to repackagers, who remove tomatoes from the 25-pound boxes the packers put them in, then ship them in containers arranged by shape, size and color, to meet the demands of different retailers. Some are processed further before going to restaurants.
The increase in food-related disease outbreaks in recent years may be nothing more than the result of better detection. Molecular fingerprinting allows scientists to link sicknesses that occur across the country to a single contaminated field. That does make an outbreak seem worse that it would have seemed at a time when not all the cases were picked up by sensitive tests.
“In the past, you’d get a bad case of diarrhea and you’d say, ‘I got the flu, I ate something bad,’” said Mark Munger, an official with Andrews and Williamson Fresh Produce in San Diego. “I’m not criticizing the way things are now. But these outbreaks should be put into perspective. We’re dealing with major obesity crisis in this country. It’s bad for consumers to think they can’t eat fresh fruits and vegetables. Wash them, sure. But, for the most part, keep eating them.”
The produce industry is demanding hearings in Congress and tomato growers are expected to ask for financial relief. Florida’s tomato industry was already hurting because of high fuel and fertilizer costs, tomato diseases and labor conflict.
To think that a little pepper could lay them so low.
Celebs Rally for Vaccine Reform
Jenny McCarthy (Gamescore, Flickr)
I spent a bright and lovely morning doing anthropology among the vaccine skeptics, an angry group who blame the government for their children’s medical and psychiatric conditions. The occasion was Wednesday’s “Green our Vaccines” rally, a march on Washington led by the the actor Jim Carrey and his photogenic girlfriend, Jenny McCarthy, the TV personality and mother of an autistic 6-year-old boy named Evan.
McCarthy, Carrey and an untold number of other people -– there were maybe 1,500 at the rally -– believe that something in vaccines causes autism. Science has laid to rest a theory blaming the measles-mumps-rubella shot, and the evidence also points away from the mercury-containing preservative, thimerosal. But Carrey and McCarthy have moved the goalposts. At Wednesday’s rally, the marchers chanted, “Too many, Too soon!” The new theory of the vaccine haters is that “too many” of these disease preventives somehow overwhelm the child’s immune system — a thesis there is no evidence to support.
Illustration by: Matt Mahurin
The anger has deep roots, though. About 1 in 150 U.S. children is diagnosed with a form of autism, compared to perhaps 1 in 3,000 two decades ago. The higher diagnoses are mainly due to changes in psychiatric codings and increased educational and therapeutic programs for autistic kids, but there may be other explanations for part of the increase. The parents of these children have difficult lives and spend hundreds of thousands of dollars to care for their kids. Feeling ripped off, they blame the government and industry, and say that environmental toxins and vaccines are responsible.
Over the decade I’ve reported on this issue, the believers have grown more and more entrenched in their convictions, to the point that it’s difficult to have a discussion because we’ve obviously been reading different material. Google University has many campuses and I’ve been attending a different one.
Blaming vaccines for autism is a small cottage industry backed by certain lawyers, alternative medicine practitioners and peddlers of dietary supplements that allegedly cure the damage done by vaccines. But whether their kids are getting better with such therapies or not, these parents’ convictions are unshaken.
Erika Stone, of Dallas, came to the rally with the righteous anger of a mother dealing with a severely ill child. She carried a sign that said, “We are your scientific evidence.” It had photographs of her 2 ½ year old son, Maxwell, and his mates from a special therapy program. Maxwell began to lose his language skills at 12 months. He’s sickly and mute and entirely dependent on her. “My child can’t say a word. He can’t hold a crayon, he can’t feed himself. If you play loud music next to him, he doesn’t even turn around.”
When Maxwell was about 20 months old, his mom heard about the vaccine theory. While the evidence of a vaccine link to her son’s condition didn’t convince me–regressive autism, of the type she describes, was known to occur long before the vaccine schedule increased — Stone said, “I believe it in the bottom of my heart – it’s something called mother’s instinct.”
If it wasn’t for the Internet, would you have been led to this conviction? I asked. “Probably not,” she said.
The group walked from its rally point under the Washington Monument, down Independence Ave (stopping to jeer at the Dept. of Health and Human Services) before filing on to the west lawn of Congress. It heard speeches from people like Rep. Dan Burton (R-Ind), Boyd Haley, a University of Kentucky chemist, and Robert F. Kennedy Jr., an environmental lawyer who displayed his ignorance of the issue in a sensationalist, error-filled 2005 article in Rolling Stone magazine.
As someone who has been following this hair-tearing controversy for a decade, I try to keep my cool, but I lost it once.
I was talking with a group of people (including a large fellow with “CDC Sucks” stitched on his shirt where the alligator should have been) when I was introduced to Wendy Fournier, an anti-vaccine activist I’ve debated on the radio. “Oh, it’s you,” I said. “I want to talk to someone less full of shit.”
No sooner had “shit” passed my lips than the people around Fournier called the rally monitor, who got on her radio and shouted, “Get a policeman over here!” The cop told me that since this was the Green People’s rally, they had the power to tell me to go away, even if I was a journalist.
I walked over to the little retaining wall around the monument and greeted Dan Olmstead, a former UPI editor who runs Age of Autism, a Website that champions the vaccines-cause-autism line and belittles those who disagree. Despite our profound differences, Dan’s an old journalist like me, and he thought it was wrong they’d sic’d the cops on me. We chatted for a while and then Terri Arranga, a “journalist” for Autism One, another vaccines=autism media outlet, came over, stuck a mike in my face and tried for a while to get me to comment about something I said on her program three years ago.
Then, McCarthy and Carrey appeared. The green-clad crowd went wild. “Jenny! Jenny!” they chanted, as the couple reviewed their troops on the lawn.
McCarthy agreed to what she called a “sound bite,” and a guy from “Access Hollywood” started to spoonfeed her questions. I was surprised — OK, disappointed: I love the actor Jim Carrey! — to note that Carrey did a lot of the talking. He offered many theories: evil drug companies, conspiratorial government scientists, etc. “How dumb does the CDC think we are?” (An intemperate question from a guy who, as Orac says, presumably doesn’t want us to think that “Dumb and Dumber” is a documentary.) Kids can’t assimilate all the vaccines, he said. We need more research that isn’t paid for by the pharmaceutical industry. “We don’t call that research, we call it propaganda.”
After asking his questions, the Access Hollywood guy suddenly became a promoter. “Jim and Jenny,” he said, “I’m proud to announce that you’ve been named Access Hollywood’s green couple of the week!”
At which point I saw my opportunity and after checking for rally monitors, asked, “How many vaccines, exactly, is too many?”
“In 1983,” McCarthy said, “our kids only got 10 vaccines. Now it’s 36” (actually, it’s 28, max, by age 2). I asked, “So should they only be getting 10? Which ones shouldn’t they get?” I saw McCarthy turning and asking someone, “Who is this guy?” Carrey responded, gamely. “Kids aren’t a bottomless pit you can pour toxins into, there has to be a limit,” he said.
“So what’s a vaccine they shouldn’t get?” I asked. “A lot of parents of autistic children would have opted not to get the tetanus shot,” he said.
Tetanus? Do they realize what it’s like to live in a pre-tetanus shot society, in villages where unvaccinated kids get tetanus –also called lockjaw. It causes your spine to arch as you writhe in agony for days and then die unless you are fortunate enough to get antitoxin. But then, Carrey and McCarthy haven’t been studying microbiology for the past 20 years.
The organizers were telling everyone to get off the grass, so I fell into step with McCarthy’s pediatrician, Dr. Jay Gordon, who’s a celebrated, or notorious, I guess, Santa Monica doctor because of his outspoken vaccine skepticism. Gordon has been an tiny thorn in the side of the pediatrics profession since 1979, and he takes obvious pride in going against the grain. I can see the appeal to going that way, too, but I don’t quite get his logic.
For example: “I think it’s good for you to get measles,” he told me. “It’s good for the immune system.”
He thinks all kids should get the measles?
“Yes, I do. The measles vaccine might be doing more harm than good.” This although, he tells me, “I know all the numbers.” (In the pre-vaccine era, measles killed 500 American children every year, caused 5,000 cases of permanent brain damage and innumerable hospitalizations. It still kills about 500,000 people each year in the Third World.)
The unvaccinated children in his practice are healthier, Gordon said. Not that he’s indiscriminately opposed to vacination. “Nobody wants a whooping cough epidemic.” He gives the DTP — diphtheria-tetanus-pertussis (whooping cough) — vaccine, but he delays the shots until the babies are a year old.
One way to tell that preconceived belief, rather than rationality, is guiding someone’s actions is by determining whether a change in the evidence affects their outlook. Two plausible theories for autism were weighed by science and found wanting. But those who remain convinced of the link have a way of rationalizing their belief, almost extemporaneously.
Like most of the people I met at the rally, Gordon wasn’t impressed by the epidemiological studies showing that mercury in vaccines hadn’t caused an upswing in autism. But like a lot of the vaccine skeptics, he’s moved on to a new culprit, another element present in tiny amounts in vaccines, where it is used as an adjuvant to boost the immune response: Aluminum.
Bush Definition of ‘Transparency’
Environmental Protection Agency Administrator Stephen Johnson (WDCpix)
The Bush administration has a pet word to describe its regulatory policy. The word is “transparent.” Last Tuesday, Environmental Protection Agency chief Stephen Johnson used it to describe an ozone ruling in which the White House at the last minute reversed EPA recommendations for limiting smog. “It’s been a very transparent process,” Johnson told Chairman Henry A. Waxman (D-Ca.) and the House Oversight and Government Reform Committee
At a House Science subcommittee hearing the next day, Susan Dudley, the top White House regulatory officer with the Office of Management and Budget, used it in reference to EPA’s toxic chemical regulations. Critics, including the Government Accountability Office, the investigative arm of Congress, claimed that toxics assessment had been paralyzed by new EPA guidelines that allow the Pentagon, industry and other actors to stop EPA evaluation of toxics without offering any rationale. “OMB,” Dudley said, “supports EPA’s efforts to provide greater transparency.
To most of us, “transparent” means something you can see into. If the ozone regulations were transparent, for example, one might expect that President George W. Bush would explain why he overturned EPA’s scientific evidence-based recommendations. When brought up to describe toxics regulation, “transparent” might mean that the public could see the paper trail providing the scientific justification behind it
But the White House seems to have found another definition of “transparent.” It means a process that the White House can see into.
Take the case of ozone. This particle, a principle component of smog, is supposed to remain less than 84 parts per billion in the air under a 1997 law. The scientific committee that advises EPA on air pollution recommended, based on newer studies, that the allowable level be reduced to 60-70 ppb, a step that the scientists expect would prevent hundreds of deaths from asthma, lung and heart disease
They also recommended that an even lower standard be set for the growing season, in order to protect certain crops that can be harmed by excess ozone. EPA scientists recommended the limit be set at 60 ppb, and Johnson recommended a 75 ppb standard when he sent the rules on to the OMB. Though he compromised on the particle level, Johnson also recommended the secondary standard for summertime.
But a week before the deadline for the rules, Dudley notified EPA that the secondary standards were unacceptable, because they didn’t take into account the economic costs of the regulation — though EPA is not supposed to take cost into account when regulating under the Clean Air Act. Eventually, Bush stepped in and “re-decider-ed,” without providing any rationale. (Read an amusing account of this story here and a more straightforward analysis here.
As in an earlier decision, on California’s request to regulate greenhouse gas tailpipe emissions, the paper trail clearly shows that the White House has reversed Johnson on important EPA regulations after industry groups lodged strong protests. “Your decisions were right on, yet in each case you backed down, you took your directions from the White House,” Waxman said Tuesday, working himself into a gavel-pounding rage at the giddily stonewalling Johnson. “That’s not how our government is supposed to work.”
Johnson smiled and gave his rote response. “I evaluated the OMB and the presidents’ comments and I made a decision,” he said. There were many “uncertainties that I factored in … With input in this case from the president. It’s been a very transparent process. I’m very proud. I think that’s good government.
The White House has been similarly transparent in its handling of the Integrated Risk Information System, or IRIS, the EPA’s database of toxic chemical assessments. When pondering how to manage industrial pollution, Superfund sites, farm runoff and the like, thousands of state, local and foreign governments rely on this critical source of impartial science, which gets 9 million visits a year.
But according to a report presented last month by the General Accountability Office, the IRIS assessment process has been strangled bureaucratically. In the past two years, only four of the EPA’s 32 draft toxics assessments have made it past Dudley’s Office of Information and Regulatory Affairs, which has the power to intervene in important agency rules.
How is this happening? According to the GAO, EPA has a new IRIS assessment process that includes two opportunities for OMB oversight. OMB often invites in the Pentagon, the Dept. of Energy and others to review these assessments, and it considers their comments “internal executive branch documents that may not be made public,” the GAO reported. In the cases of five potentially toxic chemicals, following these interagency reviews, OMB ordered EPA to stop the assessments.
In testimony on his report, the GAO’s John Stephenson said the EPA is setting lengthy deadlines to finish evaluations of the hundreds of toxic chemicals. There are always additional studies one could wait for but “if you take 10 years’’ to complete an assessment “it’s obsolete’’ when it is published, Stephenson said. As he pointed out, “If you wait until the science is perfect, you will never regulate.’’ He said that the EPA staffers he interviewed “felt they couldn’t move forward without OMB blessings several times along the way. A scientific agency is being obstructed by other agencies without science as their mission.
The OMB has long played an obstructive role in regulation. This may not be a bad thing all the time, since regulations can be costly, scientific information isn’t always precise and at some level it probably should be the prerogative of the president to decide that the cost of regulating a given hazard is not worth the cost.
What’s different about the current OMB, says Rick Melberth, a policy analyst at watchdog group OMB Watch, is that it’s gotten deeply involved not just in deciding what to do about potential risks, but in the risk assessment itself. “There has always been a clear separation between the information that goes into a decision, and the decision-making process,” he said. “This administration is not content with making the decisions the way they want to. They have a strategy of interfering with the science before it gets to the decision-making stage.
An example discussed in the GAO report is naphthalene, an apparently carcinogenic chemical that’s used by the military. EPA began assessing naphthalene in 2002, but OMB in 2006 brought the Pentagon in to comment on the risk assessment, delaying it for at least six more years.
EPA’s new review process, said House Science subcommittee chairman Brad Miller (D-N.C.) “effectively kills IRIS without honestly acknowledging that purpose.” Dudley disputed that, saying her office coordinates other agencies’ input into IRIS assessments: “Interagency coordination allows EPA to take advantage of the broad scientific expertise that exists throughout the government.
Listening to the GAO testimony transposed against that of Dudley and EPA officials, Melberth said, gives the impression “that we’re living in parallel universes. Orwellian is the word that comes to mind.”
In Orwellian terms. as in the novel, “1984,” transparency refers to the elimination of privacy. But that’s another story of our times.
Anthrax Vaccine Loses to Lobbying
Update: The Department of Health and Human Services sent a response after this story was originally posted. The department’s comment has been inserted
Six-and-a-half years after someone mailed finely milled anthrax spores to the U.S. Capitol, the industry created to respond to that attack has received billions in cash but produced little protection. A little-noticed news item last week reveals the most dramatic failure of the $5.6 billion Bioshield program, which was supposed to provide drugs and vaccines against terror agents–its cornerstone being the creation of a safe, effective vaccine against anthrax.
As demonstrated by the anthrax mailings—a case the FBI has yet to crack—deadly anthrax bacteria are a real potential threat. The most likely assailant in the October 2001 attack was an American scientist, perhaps someone who wanted not to kill, but to focus Congress’ attention on the bioterror threat.
Illustration by: Matt Mahurin
If that’s the case, the attack was extremely successful. But in the so-far fruitless effort to get a better vaccine, the government has ruined one company that was developing an inventive solution while it has allowed another, politically well-connected firm to reap the benefits.
Last week, Emergent Biosolutions, which has been making a crude anthrax vaccine since the 1960s, under various names, quietly purchased recombinant anthrax vaccine technology for the bargain-basement price of $2 million. It bought the vaccine from Vaxgen, a sophisticated, San Francisco-area company that the government drove out of business through its bungled management of the Bioshield program. Vaxgen, which once had more than 300 employees, now has six, and is basically in the process of selling off its assets.
Emergent, which is based in Rockville, Md., but makes the old vaccine at a plant in Lansing, Mich., used an army of lobbyists to undercut Vaxgen’s relationship with the Dept. of Health and Human Services. In late 2006, HHS canceled a $878 million contract with Vaxgen, leaving the company holding the bag for more than $150 million it had spent to develop the vaccine. HHS said Vaxgen had failed to meet production deadlines; Vaxgen executives said they were delayed by minor technical problems that have since been clarified.
Vaxgen continued to improve its recombinant anthrax vaccine after HHS cut it loose, but it was unable to find a major drug company to buy it. After witnessing what HHS had done to Vaxgen, former company officials say, none of the major vaccine makers wanted to enter a contract with the government.
Emergent, on the other hand, was nothing if not politically connected. Its chief executive and his wife, for example, alone donated more than $220,000 to lobbying and political campaigns. Emergent had lobbied for years to paint Vaxgen as unreliable, and it ended up buying its vaccine for a song.
The story of the recombinant anthrax vaccine stands as the most poignant fiasco of the Bioshield program. President George W. Bush announced the program in 2003, during a visit to the National Institutes of Health. Bush said the program would “put NIH squarely in the midst of our war to defend America and to defeat international terrorism.”
The idea was to provide government stimulus to get drug companies to make products that had no market other than the government. Many scientists and public health officials believed it could have the secondary benefit of stimulating the development and manufacturing of much-needed civilian vaccines, at a time when the nation’s vaccine industry had been reduced, effectively, to five companies.
But five years later, companies that signed deals with HHS to produce anthrax vaccines, as well as drugs to fight radiation sickness, have dropped out of the program after acrimonious disagreements. One company, Acambis, has delivered a successful new vaccine against smallpox–a disease that was eradicated in 1980 and is believed to exist only in two secure laboratories. Except for a related effort to make pandemic flu vaccines, none of the big vaccine manufacturers have bought into the biodefense program.
Perhaps the most egregious fallout from Bioshield, however, was the destruction of Vaxgen, a company that included some of the country’s most talented and experienced vaccine manufacturers. It was led by Lance Gordon, a scientist who helped create more than a dozen vaccines — including a groundbreaking meningitis shot now given to all children in the United States, Europe and Latin America.
“It’s a horrible story,” said Donald Francis, the former president of Vaxgen. “We spent $150 million of our own money and $100 money in NIH to develop a vaccine. We miss a deadline and they jerk the contract and destroy the company. And there aren’t many vaccine companies. They took a high-tech company capable of making vaccines and killed it!
“This is a symptom of a government that doesn’t know what it’s doing when it comes to interacting with the private sector,” said Francis, who now leads a non-government organization that promotes vaccination in poor countries. “The Pentagon knows how to do things like this. Health and Human Services had never contracted out anything this big, and they didn’t know what they were doing.”
Under the terms of its contract with HHS, Vaxgen was obligated to use an aluminum-based adjuvant, or immune-stimulator, in the vaccine. But the adjuvant and the anthrax protein interacted in a way that caused the vaccine to lose potency. As a result, the company wasn’t able to meet its deadline for delivering the vaccine. “With trial and error we could have fixed the problem,” another former Vaxgen executive said. “It wasn’t a fundamental safety or efficacy problem.”
But Emergent, which was already producing an outdated anthrax vaccine, spent large sums of money on a lobbying campaign against Vaxgen, including hiring two former aides to Vice President Dick Cheney. Congressmen like Michael McCaul (R-Texas) and Mike Rodgers (R-Mich.), both recipients of Emergent executives’ campaign donations, attacked the Vaxgen contract in committee hearings, while Emergent’s lawyers wrote newspaper op-eds attacking the company.
What’s more, HHS frequently changed officials in charge of overseeing the contract, and none seemed to understand the complexities of making vaccines, the Vaxgen officials said. This impression was echoed by two other officials — one at another company, the other at the Centers for Disease Control — who asked not to be named.
While HHS has said it followed the letter of the law in canceling the contract, Vaxgen officials say it caved to political pressure. “We were under the illusion that if we did good science, we’d win out,” the official said. “That’s not how this works. Politics played a more important role than science.” A government scientist familiar with the deal said that while Vaxgen was not blameless, its problems were typical of the trial-and-error nature of the vaccine-making process.
HHS spokesman Bill Hall denied that the agency had erred in withdrawing the Vaxgen contract. Vaxgen missed its deadlines and failed to fix its problems, he said, and HHS was still pursuing a recombinant anthrax vaccine.
The Vaxgen vaccine uses a refined anthrax protein and is designed to require three doses for long-term immunity. HHS signed the deal with Vaxgen to place the 1950s-vintage vaccine produced by Emergent, formerly called Bioport. The older vaccine, made from material extracted from living bacteria, requires six doses — and yearly boosters.
In 1998, Bioport took over the Michigan state biologics laboratory, the nation’s sole manufacturer of anthrax vaccine. Starting with the Gulf War, all U.S. service members have received the vaccine. Many have blamed it for a variety of health problems, including autoimmune disorders. While expert panels have refuted claims that the vaccine causes seriously problems except in rare cases, resistance to the vaccine created a morale problem on some military bases. In 1998, for example, pilots at Dover Air Base in Delaware refused the vaccine, forcing their commander to suspend vaccination against anthrax.
After signing the 2004 contract with HHS, Vaxgen had two years to come up with 25 million doses of vaccine. In November 2006, the vaccine was not ready, and the contract was canceled.
But since the Vaxgen fiasco, the government has relaxed the rules, so that Emergent — which, according to its Website, expects to seek an HHS contract for the vaccine soon — will have several years to deliver it. The government will also provide milestone payments and cover development costs — something it didn’t do for Vaxgen.
“If we had had that system two years ago,” said Gordon, “Vaxgen would probably already have provided millions of doses of a vaccine already to the national stockpile.”
But the Emergent company spokeswoman, Tracey Schmitt, said, “We believe that Emergent has both the experience and expertise to pursue development of this important medical countermeasure to meet the United States government’s stated need.” She declined to comment on the rest of this article.
Perhaps the worst fallout of the affair is the loss of Vaxgen. Over the past 30 years, most vaccine manufacturers have gradually gotten out of the business. The United States has to import all of its whooping cough vaccine, as well as more than half the 110 million doses of flu vaccine it uses every year. “If there were a bad flu year—not to speak of a pandemic—we would need hundreds of millions of doses,” says Gordon. “And during bad flu years, most countries prohibit export of their flu vaccine.”
Vaxgen had built a factory in South Korea, originally to make an HIV vaccine (which failed), and has another state-of-the-art factory in South San Francisco sitting idle. “We were becoming a company that could develop and manufacture a number of vaccines,” says Gordon, who recently started a new biotech company. “As a result of the cancellation of contract, that was thrown away.’’
Gordon tries to view the latest twist in a positive light. “I’m glad that someone picked up our recombinant vaccine,” he said. “From my perspective, it’s a good product. I’m hopeful that the huge investment and time and effort that went into it won’t go to waste.”
For $2 million, Emergent bought enough vaccine antigen to make millions of doses, along with the recipes it needs to make the vaccine. Including NIH and other funds, more than $250 million was spent to develop it.
“I hope we never find out whether it’s really effective in humans,” added Gordon. “God willing, another major anthrax attack will never happen.”
