Thursday, December 13, 2007

Common Children's Vaccine Recalled


AP Business Writer

The recall of a routine vaccine for babies due to contamination risks could trigger a shortage and likely will alarm parents, but officials said there is no known health threat.

The recall announced Wednesday covers roughly 1.2 million doses of the vaccine against Hib, which causes meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The Hib vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.

Drugmaker Merck & Co. produces about half of the nation's annual supply of 14 million doses of Hib vaccine.

Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots.

"The potential for contamination of any individual vaccine is low," said Kelley Dougherty, a spokeswoman for the Whitehouse Station-based company.

Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.

"This is not a health threat in the short run, but it is an inconvenience," she said.

Barbara Kuter, Merck's head of pediatric medical affairs, told The Associated Press that the company will not be able to supply any vaccine for at least nine months.

"Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production next fall, she said.

"It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear.

Donna Cary, spokeswoman for Sanofi Pasteur, the only other company making the vaccine for the U.S., said it was too soon to say whether it can boost production. The company, a unit of Paris-based drugmaker Sanofi-Aventis SA, makes an Hib vaccine in France that is distributed both to the U.S. and other countries.

"We're looking at what we can add and we're working closely with the CDC on this," to see whether some vaccine could be shifted to the U.S. from other countries, Cary said.

Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

It was unclear how many of the 1.2 million doses were administered to children.

The recalled doses, distributed beginning in April, are considered potent, so revaccinations won't be needed, Schuchat said.

Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, skin irritation around the shot site. Problems could be worse for children with weakened immune systems.

Any problems would have appeared within a week of vaccination, Schuchat said, and there have been no such reports.

The contamination was on unspecified equipment used in making the vaccine. Kuter said a sterility test during a routine evaluation of Merck's West Point, Pa., vaccine plant determined that the equipment was contaminated with a common bacterium called Bacillus cereus, or B. cereus.

It is a spore-making microorganism commonly associated with food poisoning and causes diarrhea and vomiting in people who eat contaminated foods.

The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection.

This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from some worried parents.

Merck is one of the few drugmakers that make vaccines. Company representatives could not immediately say how much revenue the Hib vaccine produces.

While the company took a black eye with its September 2004 withdrawal of painkiller Vioxx due to increased heart attack risk, it has been performing well recently. It gave an upbeat assessment Tuesday in its annual briefing for analysts.

Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.

Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well, and profits are up. Merck posted a 62 percent increase in its third-quarter profit as revenues jumped 12 percent.

The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines.

Merck shares fell 68 cents Wednesday to close at $59.72 before the recall announcement. The shares fell 12 cents in after-hours trading.

Tuesday, October 30, 2007

KNOW . . . The Autism – Vaccine Connection

KNOW . . . The Autism – Vaccine Connection


http://www.know-vaccines.org/autism.html

Autism is a disease involving the brain, the immune system, and the gastrointestinal tract. Once an uncommon disorder in the United States, the incidence of autism is now occurring at epidemic rates. Whereas during the 1970’s one in 10,000 children developed autism, it now affects as many as one in 500. What could explain this alarming trend?

Given the growing burden this epidemic is putting upon both our health care and school systems, it would be informative to know what causes this frightening disease. One might assume that genetics is the culprit since no other cause is offered. However, one might also ask how it is possible to have such an epidemic based solely on genetics. The fact is we are rarely invited to debate the controversy over the nature of this epidemic because the most plausible cause, which relates to changes in vaccination programs over the past three decades, is not readily accepted by a public that believes vaccination is safe, effective and health promoting.

While it is certain that genetics predisposes individuals to certain diseases, as with all pathology the triggers for disease involve immune system dysfunction brought about by dietary deficiencies and/or environmental stress. In the case of autism, research shows that a high percentage of those affected are victims of massive chemical toxicity. The neurological damage that is characteristic with autism is strikingly similar to the well-established side effects of mercury, aluminum and formaldehyde toxicity. These neurotoxins are common vaccine ingredients.

During the 1940's and 50's when only some of the population was exposed to only a few vaccines, autism was primarily confined to the upper and upper-middle socioeconomic classes, those who could afford good health care and the cost of vaccination.

During the 1970’s and 80’s, the federal government established goals for improving vaccination rates. To achieve high vaccination rates (97%), the government implemented nationwide vaccine initiatives, which included offering federal grants to states and encouraging strict enforcement (state mandates for forced vaccination). During this time period, the number of mandated vaccines gradually increased (from 8 in 1980 to 22 in 2000) as vaccination became a requirement for a much younger population (the majority of all 30 childhood vaccines are administered before the age of 18 months). Only after these developments did autism cross class lines. Today autism is widespread in all socioeconomic groups.

The way in which autism developed in children changed after the mid-1980’s. Parents began reporting that their children developed normally during the first year and half and THEN became autistic. It is a fact that most vaccines contain toxic mercury, many of them grossly in excess of EPA permissible standards for ADULTS!

In 1979, the mercury-containing MMR was added to the vaccine schedule. In 1988, the mercury-containing HIB vaccine was added. Mercury-containing Hepatitis B for newborns was added in the early 1990’s. Children receive all these vaccines, plus mercury-containing DTP, in three to four toxic doses during the first year and a half of their fragile lives, and the vaccines are usually administered simultaneously (multiple mercury-containing vaccines on the same day).

These facts beg the question: At what point does an immature immune system reach a saturation point for toxic chemicals injected into the blood stream? When mercury can't get processed out of body, it travels to the brain where it clings to tissue in the cerebellum (affecting movement and balance), in the amygdala (affecting emotional processing) and in the hippocampus (affecting the formation, sorting and storage of information). The strong correlation between autism and vaccine history becomes even more credible when the disease characteristics for both autism and mercury poisoning are compared:

The Autism – Vaccine Connection:
Comparison of Characteristics

AUTISM MERCURY POISONING
Motor Skills and Movement Disorders Uncoordinated; clumsiness; rocking; circling; flaps arms; walks on toes; difficulty with walking, sitting, crawling; difficulty with swallowing or chewing Uncoordinated; clumsiness; rocking; circling; flaps arms; walks on toes; difficulty with walking or sitting; difficulty with swallowing or chewing
Sensory Disorders Oversensitive to sound; does not like to be touched; abnormal sensations in mouth, arms and legs Oversensitive to sound; does not like to be touched; abnormal sensations in mouth, arms and legs
Speech, Hearing & Language Development Delayed language or failure to develop speech; problems with articulation; mild to severe hearing loss; word use errors Loss of speech or failure to develop speech; problems with articulation; mild to severe hearing loss; word retrieval problems
Cognitive Ability Borderline intelligence; mental retardation (may be reversed); poor concentration and attention; difficulty following complex commands; difficulty with word comprehension; difficulty with understanding abstract ideas and symbols Borderline intelligence; mental retardation (may be reversed); poor concentration & attention; difficulty following complex commands; difficulty with word comprehension; difficulty with understanding abstract ideas and symbols
Physical Characteristics and Functional Disturbances Weakening muscle strength, especially upper body; rash, dermatitis; abnormal sweating; poor circulation and high heart rate; diarrhea, constipation, abdominal discomfort and incontinence; anorexia; seizures; tendency to have allergies and asthma; family history of autoimmune symptoms, especially rheumatoid arthritis Weakening muscle strength, especially upper body; rash, dermatitis; abnormal sweating; poor circulation and high heart rate; diarrhea, constipation, abdominal discomfort and incontinence; anorexia; seizures; tendency to have allergies and asthma; more likely to have autoimmune symptoms, especially rheumatoid arthritis
Behavior Difficulty sleeping; staring and unprovoked crying; injures self (such as head banging); social isolation Difficulty sleeping; staring and unprovoked crying; injures self (such as head banging); social isolation
Visual Problems Poor eye contact; blurred vision Poor eye contact; blurred vision

Tuesday, September 25, 2007

Study Questions Flu Shot's Value for Older People

Tuesday, September 25, 2007; 12:00 AM

TUESDAY, Sept. 25 (HealthDay News) -- The ability of flu shots to reduce the risk of influenza-related death among people 65 and older may be greatly exaggerated, say researchers who reviewed the available scientific evidence.

This exaggeration is the result of "frailty selection bias" -- where not-so-frail older people are vaccinated more often than those who are infirm, the team said. It's also due to the use of non-specific clinical trail endpoints, such as death from any and all causes, wrote a group led by Dr. Lone Simonsen, of George Washington University in Washington, D.C.

They reported their conclusions in the October issue ofThe Lancet Infectious Diseasesjournal.

The researchers noted that few clinical trials of flu vaccines have included seniors, especially those aged 70 and older -- the age group that accounts for 75 percent of all influenza-related deaths. Those studies that have been conducted with seniors suggested a steady decline in clinical benefits and vaccine antibody responses after age 70.

The review authors also found that, even though vaccination rates increased from 15 percent to 65 percent since 1980, studies have not been able to confirm a corresponding decline in flu-related deaths.

"Paradoxically, whereas those studies attribute about five percent of all winter deaths to influenza, many cohort studies report a 50 percent reduction in the total risk of death in winter -- a benefit ten times greater than the estimated influenza mortality burden," the review authors wrote.

Future studies on flu vaccines in older groups should use more specific endpoints and actual virus surveillance data for each flu season, rather than the current arbitrary four-month period, the team added.

Despite the current lack of evidence, the review authors do recommend that seniors continue to get flu shots.

"While awaiting an improved evidence base for influenza vaccine mortality benefits in elderly people, we suggest that this group should continue to be vaccinated against influenza. Influenza causes many deaths each year, and even a partly effective vaccine would be better than no vaccine at all," they said. "But the evidence base concerning influenza vaccine benefits in elderly people does need to be strengthened."

More information

Monday, August 27, 2007

Georgia 14th in ranking of adult obesity

ajc.com > Living


By BOB DART
Cox News Service
Published on: 08/27/07

WASHINGTON — Hold the grits and gravy, y'all! Ten of America's 15 fattest state populations are in Dixie — including Georgia, which ranks 14th in the adult rate of obesity and 12th for youths ages 10 through 17, a health report to be released Tuesday found.

Part of blame falls on the traditional Southern diet — heavy on fried foods and down home carbohydrates in cornbread, biscuits, peach cobbler and such. But the region's obesity can also be linked to lifestyle and economics, said the authors of the annual report by Trust for America's Health.

"Historic cultural preference for certain types of food" certainly plays a part in the regional variations, said Jeff Levi, executive director of the Trust. But "we also looked at poverty and physical inactivity rates this year — which show correlations with the obesity rates."

Seven of the 10 states with the highest rates of physical inactivity — "where people don't exercise" — are in the South, he pointed out. Mississippi — with the fattest adult population — also leads the inactivity list, with 31.6 percent of adults who say they don't exercise.

"And eight of the ten states with the highest rates of poverty are also in the South," said Levi. Mississippi ranks only behind the District of Columbia in its poverty level.

Among the 50 states and District of Columbia, Georgia has the 13th highest inactivity rate, at 25.9 percent, and ranks 17th on the poverty scale, at 13.1 percent.

About 26 percent of Georgia adults are obese, as are 16.4 percent of youths, according to the report.

"Many factors contribute to obesity," said Levi. "And one thing we call for is more research into understanding why rates vary in different regions and states."

Colorado is the leanest state, but even it's obesity rate for adults increased over the past year, from 16.9 to 17.6 percent.

Mississippi topped the list with the highest rate of adult obesity in the country for the third year in a row, and is the first state to reach a rate of over 30 percent — at 30.6 percent.

Behind Mississippi, the states in descending order of adult obesity rates were: West Virginia, Alabama, Louisiana, a tie between South Carolina and Tennessee, Kentucky, Arkansas, a tie between Indiana and Michigan, Oklahoma, Missouri, Texas, Georgia and Ohio.

The 15 states with the highest obesity rates for youths ages 10 through 17 were: D.C., West Virginia, Kentucky, Tennessee, North Carolina, Texas, South Carolina, Mississippi, Louisiana, New Mexico, Alabama, Arkansas, Georgia, Illinois, and Indiana. Georgia and Arkansas tied for 12th.

This fourth annual "F as in Fat: How Obesity Policies Are Failing in America" report found that adult obesity rates rose in 31 states over the past year, and such rates now exceed a quarter of the population in 19 states.

The rate of adult obesity has remained consistent in Georgia since last year.

No state experienced a decrease. Eight-five percent of Americans believe obesity is an epidemic, according to a public opinion survey also featured in the report.

"Overall, we know the rates are continuing to rise in the nation overall, so we really do need to look at regional differences," said Levi. "But also come up with a clear, comprehensive national game plan to address obesity more effectively."

He said the report is being discussed at a "Southern Obesity Summit: Promising Obesity Prevention Strategies in the Southern States" to be held in Little Rock on Aug. 27-28.

The meeting will ask why Southerners are the fattest of Americans, he said. "Representatives from 14 states in the South are coming together to discuss this exact issue - and ways to try to deal with it."

The report found that Americans are aware that they're too fat — but not doing enough to change.

"There has been a breakthrough in terms of drawing attention to the obesity epidemic. Now, we need a breakthrough in terms of policies and results," Levi. "Poor nutrition and physical inactivity are robbing America of our health and productivity."

The state rankings for adult obesity are based on three years of data — 2004 through 2006 — from the U.S. Centers for Disease Control and Prevention's Behavioral Risk Surveillance System. The youth rankings were based on the National Survey of Children's Health, a phone survey of parents of children ages 10 through 17 conducted in 2003 and 2004 by the U.S. Department of Health and Human Services. The report also contains a national public opinion survey conducted from July 12 through 16 with a margin of error of plus or minus 3.1 percent.

Trust for America's Health is a non-profit, non-partisan organization that describes itself as "dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority." Funding for the report was provided by the Robert Wood Johnson Foundation, which focuses on health care issues.

Sunday, July 29, 2007

Under The Influence

Under The Influence
NEW YORK, April 1, 2007
(CBS) This segment was originally broadcast on April 1, 2007. It was updated on July 23, 2007.

If you have ever wondered why the cost of prescription drugs in the United States are the highest in the world or why it's illegal to import cheaper drugs from Canada or Mexico, you need look no further than the pharmaceutical lobby and its influence in Washington, D.C.

According to a report by the Center for Public Integrity, congressmen are outnumbered two to one by lobbyists for an industry that spends roughly $100 million a year in campaign contributions and lobbying expenses to protect its profits.

One reason those profits have exceeded Wall Street expectations is the Medicare prescription drug bill. It was passed more than three-and-a-half years ago, but as 60 Minutes correspondent Steve Kroft reports, its effects are still reverberating through the halls of Congress, providing a window into how the lobby works.



The unorthodox roll call on one of the most expensive bills ever placed before the House of Representatives began in the middle of the night, long after most people in Washington had switched off C-SPAN and gone to sleep.

The only witnesses were congressional staffers, hundreds of lobbyists, and U.S. representatives, like Dan Burton, R-Ind., and Walter Jones, R-N.C.

"The pharmaceutical lobbyists wrote the bill," says Jones. "The bill was over 1,000 pages. And it got to the members of the House that morning, and we voted for it at about 3 a.m. in the morning," remembers Jones.

Why did the vote finally take place at 3 a.m.?

"Well, I think a lot of the shenanigans that were going on that night, they didn't want on national television in primetime," according to Burton.

"I've been in politics for 22 years," says Jones, "and it was the ugliest night I have ever seen in 22 years."

The legislation was the cornerstone of Republican's domestic agenda and would extend limited prescription drugs coverage under Medicare to 41 million Americans, including 13 million who had never been covered before.

At an estimated cost of just under $400 billion over 10 years, it was the largest entitlement program in more than 40 years, and the debate broke down along party lines.

But when it came time to cast ballots, the Republican leadership discovered that a number of key Republican congressmen had defected and joined the Democrats, arguing that the bill was too expensive and a sellout to the drug companies. Burton and Jones were among them.

"They're suppose to have 15 minutes to leave the voting machines open and it was open for almost three hours," Burton explains. "The votes were there to defeat the bill for two hours and 45 minutes and we had leaders going around and gathering around individuals, trying to twist their arms to get them to change their votes."

Jones says the arm-twisting was horrible.

"We had a good friend from Michigan, Nick Smith, and they threatened to work against his son who wanted to run for his seat when he retired," he recalls. "I saw a woman, a member of the House, a lady, crying when they came around her, trying to get her to change her votes. It was ugly."

When the prescription drug bill finally passed shortly before dawn, in the longest roll call in the history of the House of Representatives, much of the credit went to former Congressman Billy Tauzin, R-La., who steered it through the house.

"It's just a messy process," Tauzin says. "I mean, the old adage about if you like sausage or laws, you should not watch either one of them being made is true. It's a messy process."

Tauzin says that the voting machines were open for three hours "because the vote wasn't finished."

As for arms being twisted? "People were being talked to," he says.

And of Walter Jones' comment that it was the "ugliest night" he had "ever seen in politics in 22 years?"

"Well, he's a young member," counters Tauzin with a laugh. "Had he been around for 25 years, he'd have seen some uglier nights."

It certainly wasn't ugly for the drug lobby which invested more than $10 million in campaign contributions during the last election and has been a source of lucrative employment opportunities for congressmen when they leave office.

Former senators Dennis Deconcini, D-Ariz., and Steve Symms, R-Idaho, and former congressmen like Tom Downey, D-N.Y.; Vic Fazio, D-Calif.; Bill Paxon, R-N.Y., and former House Minority Leader Robert Michel, R-Ill., all registered as lobbyists for the drug industry and worked on the prescription drug bill.

"I can tell you that when the bill passed, there were better than 1,000 pharmaceutical lobbyists working on this," says Rep. John Dingell, D-Mich.

Dingell has been in Congress for 52 years and is the chairman of the House Energy and Commerce Committee, which shares jurisdiction over Medicare. He says the bill would not have passed without the efforts of the drug lobby.

"There is probably a lotta truth in it that the bill was stacked in their benefit. And it's probably also true that it was written by their lobbyists," he says.

Says Jones: "You couldn't even walk to the steps of the Capitol without having somebody, maybe one or two, coming up to you to say, 'Can't you change your vote? Can't you vote for this bill?' "

Why was the drug lobby was so interested in this bill and what did it have to gain? Ron Pollack, the executive director of Families USA, a nonpartisan health care watchdog group, says it all boiled down to a key provision in the legislation.

It prohibited Medicare and the federal government from using its vast purchasing power to negotiate lower prices directly from the drug companies.

"The key goal was to make sure there'd be no interference in the drug companies' abilities to charge high prices and to continue to increase those prices," says Pollack.

Pollack says there's no question that this was prompted by the pharmaceutical lobby.

"They were the ones who wanted to make sure Medicare could charge high prices and to continue to increase those prices," he says.

The drug industry says that competition among private insurance plans that service the Medicare program help keep prices low. But Families USA reported in a January study that Medicare patients are being charged nearly 60 percent more for the top 20 drugs than veterans pay under a program run by the U.S. Department of Veterans Affairs.

For example, Lipitor, a popular cholesterol drug, the cheapest Medicare price is $785 for a year's supply — 50 percent more than the VA's price of $520.

For Zocor, another cholesterol drug, the best Medicare price is $1,485 for a year's supply. The same drug only costs $127 a year under the VA's plan.

Read the full Families USA report
Pollack says the VA successfully negotiates with the drug companies on price.

"Medicare could do the same thing," he says, "but Medicare is prohibited from doing that as a result of this new Medicare legislation."

"What was the logic? Or what was the idea, the rationale behind not giving the government the ability to negotiate drug prices?" Kroft asks Rep. Dan Burton.

Burton says it was simply that the drug companies didn't want it. "They wanted to make as much as money as possible. And if there's negotiation, like there is in other countries around the world, then they're gonna have their profit margin reduced," he says.

Before the vote, Congress was told the program would cost a whopping $395 billion over the first 10 years. In fact, Medicare officials already knew it was going to cost a lot more.

Burton said he and others were misled. "Within two weeks after the bill was passed, everybody knew it was gonna cost well over $500 billion," he says. "And many members of the Congress [who] had voted for it said, 'I would never have voted for it had I known that.' "

Medicare Chief Actuary Richard Foster later told Congress that he revised the cost estimate to $534 billion before the vote, but was told to withhold the new numbers if he wanted to keep his job.

During a Congressional hearing, Foster stated: "It struck me there was a political basis for making that decision. I considered that inappropriate and, in fact, unethical."

Foster said the person who told him to withhold Congress from getting the revised estimates was Medicare boss Tom Scully.

Scully was the administration's lead negotiator on the prescription drug bill, and at the time was also negotiating a job for himself with a high-powered Washington law firm, where he became a lobbyist with the pharmaceutical industry.

"He was negotiating for his job at the same time that the Medicare legislation was being considered. He wound up taking this job 10 days after the president signed this legislation," says Pollack.

It is but one example of the incestuous relationship between Congress and the industry, and just one of the reasons the pharmaceutical lobby almost never loses a political battle that affects its bottom line.

Former Congressman Billy Tauzin, who helped push the prescription drug bill through the House, didn't disagree.

Has the bill been good for the drug industry?

"It's been good for the patients whom the drug industry represents …" Tauzin says. "In terms of profits — [for the drug companies] and volumes, yes."

Says Kroft: "Your old friend, John Dingell, says that of the 1,500 bills over the last eight years dealing with pharmaceutical issues, the drug companies almost, without exception, have gotten what they wanted."

"Yeah … I would think he's correct. They've done fairly well," replies Tauzin.

Why has this lobby been so successful? The former congressman says he believes it's because they stood for the right things.

If Tauzin sounds a lot like a lobbyist for the drug industry, that's because now he is.

Just a few months after the prescription drug bill passed, Tauzin began discussions with the pharmaceutical industry to become its chief lobbyist in Washington. He says it was one of several lucrative offers he's received just before he got some very bad news.

"I got a call from a doctor in Bethesda who said, 'You got cancer. And it's extremely rare. And it could kill ya.' And then everything changed," Tauzin says.

Tauzin had a cancerous tumor removed from his intestines and was treated with a new medicine, called Avastin, that had never been used before on that form of cancer.

The treatment was successful, and as a result Tauzin says he felt he owed his life to the drug industry. After serving out his congressional term, he accepted a $2 million-a-year job as president of PhRMA — Pharmaceutical Research and Manufacturers of America.

"There was an extraordinary moment when my wife literally looked me in the eye and said, 'Look, you're gonna do well wherever you go, Billy … You got a lot a great offers … And maybe you oughta think about working for the people that struggle everyday to try to invent the medicines that save lives like yours.'

"And that was a pretty important moment in my life," Tauzin says. "And it was the moment I decided that this was the work I wanted to do — headaches and all."

Jones and Burton agree that the perception of Tauzin's move is not good.

"I mean, when you're pushing so hard for a bill that's controversial and you have to keep the machine open for three hours to get the one vote necessary to pass it, and then, within a matter of months you go to work for the industry that's gonna benefit from it, it does cause you some concern," says Burton.

They are not the only ones cynical about the decision.

"You push this bill through that produces a windfall for the drug companies. And then a short time later, you go to work for the drug lobby at a salary of $2 million. That doesn't look good," Kroft tells Tauzin.

"There was nothing I could've done in my life after leaving Congress that wouldn't have had — I didn't have some impact on in 25 years in Congress … If that looks bad to you, have at it," Tauzin says. "That's the truth."

In fairness to Tauzin and former Medicare chief Tom Scully, they weren't the only public officials involved with the prescription drug bill who later went to work for the pharmaceutical industry.

Just before the vote, Tauzin cited the people who had been most helpful in getting it passed. Among them:

  • John McManus, the staff director of the Ways and Means subcommittee on Health. Within a few months, he left Congress and started his own lobbying firm. Among his new clients was PhRMA, Pfizer, Eli Lilly and Merck.

  • Linda Fishman, from the majority side of the Finance Committee, left to become a lobbyist with the drug manufacturer Amgen.

  • Pat Morrisey, chief of staff of the Energy and Commerce Committee, took a job lobbying for drug companies Novartis and Hoffman-La Roche.

  • Jeremy Allen went to Johnson and Johnson.

  • Kathleen Weldon went to lobby for Biogen, a Bio-tech company.

  • Jim Barnette left to lobby for Hoffman-La Roche.

    In all, at least 15 congressional staffers, congressmen and federal officials left to go to work for the pharmaceutical industry, whose profits were increased by several billion dollars.

    "I mean, they — they have unlimited resources. Unlimited," Burton says. "And when they push real hard to get something accomplished in the Congress of the United States, they can get it done."


  • 60 Minutes Link

    Sunday, July 22, 2007

    Deadly Immunity

    Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal

    ROBERT F. KENNEDY JR.

    Posted Jun 20, 2005 12:00 AM

    In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

    The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.

    Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said. "Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."

    But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives at Simpsonwood spent most of the next two days discussing how to cover up the damaging data. According to transcripts obtained under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal would affect the vaccine industry's bottom line. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible hands." Dr. John Clements, vaccines advisor at the World Health Organization, declared that "perhaps this study should not have been done at all." He added that "the research results have to be handled," warning that the study "will be taken by others and will be used in other ways beyond the control of this group."

    In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication, and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

    Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.

    The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children. On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood transcripts -- and shield Eli Lilly, the developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the "Eli Lilly Protection Act" into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on bioterrorism. The measure was repealed by Congress in 2003 -- but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," says Dean Rosen, health policy adviser to Frist.

    Even many conservatives are shocked by the government's effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin." The FDA and other public-health agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism of the pharmaceutical industry."

    The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical.

    I doubted that autism could be blamed on a single source, and I certainly understood the government's need to reassure parents that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for leaping to conclusions about autism and vaccinations. "Why should we scare people about immunization," Waxman pointed out at one hearing, "until we know the facts?"

    It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the nation's pre-eminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real. Five of my own children are members of the Thimerosal Generation -- those born between 1989 and 2003 -- who received heavy doses of mercury from vaccines. "The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage," Patti White, a school nurse, told the House Government Reform Committee in 1999. "Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children."

    More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The disease was unknown until 1943, when it was identified and diagnosed among eleven children born in the months after thimerosal was first added to baby vaccines in 1931.

    Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is a result of better diagnosis -- a theory that seems questionable at best, given that most of the new cases of autism are clustered within a single generation of children. "If the epidemic is truly an artifact of poor diagnosis," scoffs Dr. Boyd Haley, one of the world's authorities on mercury toxicity, "then where are all the twenty-year-old autistics?" Other researchers point out that Americans are exposed to a greater cumulative "load" of mercury than ever before, from contaminated fish to dental fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It's a concern that certainly deserves far more attention than it has received -- but it overlooks the fact that the mercury concentrations in vaccines dwarf other sources of exposure to our children.

    What is most striking is the lengths to which many of the leading detectives have gone to ignore -- and cover up -- the evidence against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative, which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines -- and that the developing brains of infants are particularly susceptible. In 1977, a Russian study found that adults exposed to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later. Russia banned thimerosal from children's vaccines twenty years ago, and Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have since followed suit.

    "You couldn't even construct a study that shows thimerosal is safe," says Haley, who heads the chemistry department at the University of Kentucky. "It's just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage."

    Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause damage -- and even death -- in both animals and humans. In 1930, the company tested thimerosal by administering it to twenty-two patients with terminal meningitis, all of whom died within weeks of being injected -- a fact Lilly didn't bother to report in its study declaring thimerosal safe. In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about thimerosal's safety "did not check with ours." Half the dogs Pittman injected with thimerosal-based vaccines became sick, leading researchers there to declare the preservative "unsatisfactory as a serum intended for use on dogs."

    In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison." In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the concentration in a typical vaccine. Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords.

    In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.

    The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck's vaccine programs, warned the company that six-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."

    For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper for international agencies to distribute them to impoverished regions at risk of epidemics. Faced with this "cost consideration," Merck ignored Hilleman's warnings, and government officials continued to push more and more thimerosal-based vaccines for children. Before 1989, American preschoolers received eleven vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of twenty-two immunizations by the time they reached first grade.

    As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development. Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury that children would receive from the mandated vaccines. "What took the FDA so long to do the calculations?" Peter Patriarca, director of viral products for the agency, asked in an e-mail to the CDC in 1999. "Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"

    But by that time, the damage was done. At two months, when the infant brain is still at a critical stage of development, infants routinely received three inoculations that contained a total of 62.5 micrograms of ethylmercury -- a level 99 times greater than the EPA's limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies -- including one published in April by the National Institutes of Health -- suggest that ethylmercury is actually more toxic to developing brains and stays in the brain longer than methylmercury.

    Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose vials that don't require a preservative. Dr. Paul Offit, one of CDC's top vaccine advisers, told me, "I think if we really have an influenza pandemic -- and certainly we will in the next twenty years, because we always do -- there's no way on God's earth that we immunize 280 million people with single-dose vials. There has to be multidose vials."

    But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the additional vaccines had close ties to the industry. Dr. Sam Katz, the committee's chair, was a paid consultant for most of the major vaccine makers and was part of a team that developed the measles vaccine and brought it to licensure in 1963. Dr. Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott Labs for his research on the hepatitis B vaccine.

    Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common. Rep. Burton says that the CDC "routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines," even though they have "interests in the products and companies for which they are supposed to be providing unbiased oversight." The House Government Reform Committee discovered that four of the eight CDC advisers who approved guidelines for a rotavirus vaccine "had financial ties to the pharmaceutical companies that were developing different versions of the vaccine."

    Offit, who shares a patent on one of the vaccines, acknowledged to me that he "would make money" if his vote eventually leads to a marketable product. But he dismissed my suggestion that a scientist's direct financial stake in CDC approval might bias his judgment. "It provides no conflict for me," he insists. "I have simply been informed by the process, not corrupted by it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this country. It's offensive to say that physicians and public-health people are in the pocket of industry and thus are making decisions that they know are unsafe for children. It's just not the way it works."

    Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians of children's health, proud of their "partnerships" with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children's health. They are often resentful of questioning. "Science," says Offit, "is best left to scientists."

    Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added baby vaccines. "I'm not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy bodies may have been asleep at the switch re: thimerosal until now," Patriarca wrote. The close ties between regulatory officials and the pharmaceutical industry, he added, "will also raise questions about various advisory bodies regarding aggressive recommendations for use" of thimerosal in child vaccines.

    If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines -- which had been developed largely at taxpayer expense -- over to a private agency, America's Health Insurance Plans, ensuring that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders. The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM's Immunization Safety Review Committee, told her fellow researchers when they first met in January 2001. "We are not ever going to come down that [autism] is a true side effect" of thimerosal exposure. According to transcripts of the meeting, the committee's chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a causal relation" between thimerosal and autism. That, she added, was the result "Walt wants" -- a reference to Dr. Walter Orenstein, director of the National Immunization Program for the CDC.

    For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything they had worked for. "We've got a dragon by the tail here," said Dr. Michael Kaback, another committee member. "The more negative that [our] presentation is, the less likely people are to use vaccination, immunization -- and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge."

    Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about vaccines. "Four current studies are taking place to rule out the proposed link between autism and thimerosal," Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering in May 2001. "In order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety." Douglas formerly served as president of vaccinations for Merck, where he ignored warnings about thimerosal's risks.

    In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the report relied on four disastrously flawed epidemiological studies examining European countries, where children received much smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young to have been diagnosed with autism and overlooked others who showed signs of the disease. The IOM declared the case closed and -- in a startling position for a scientific body -- recommended that no further research be conducted.

    The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies that were "fatally flawed" by "poor design" and failed to represent "all the available scientific and medical research." CDC officials are not interested in an honest search for the truth, Weldon told me, because "an association between vaccines and autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that conclusion about themselves?"

    Under pressure from Congress and parents, the Institute of Medicine convened another panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program. In February, the new panel, composed of different scientists, criticized the way the VSD had been used in the Verstraeten study, and urged the CDC to make its vaccine database available to the public.

    So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines.

    As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children who had not been exposed to mercury in vaccines -- the kind of population that scientists typically use as a "control" in experiments -- Olmsted scoured the Amish of Lancaster County, Pennsylvania, who refuse to immunize their infants. Given the national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had been exposed to high levels of mercury from a power plant. The other three -- including one child adopted from outside the Amish community -- had received their vaccines.

    At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was busy whitewashing the risks, the Iowa legislature was carefully combing through all of the available scientific and biological data. "After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidences in autism," says state Sen. Ken Veenstra, a Republican who oversaw the investigation. "The fact that Iowa's 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children's vaccine schedules, is solid evidence alone." Last year, Iowa became the first state to ban mercury in vaccines, followed by California. Similar bans are now under consideration in thirty-two other states.

    But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved with thimerosal to developing countries -- some of which are now experiencing a sudden explosion in autism rates. In China, where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced vaccines. The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that it is linked to neurological disorders "under review."

    I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine. "The CDC is guilty of incompetence and gross negligence," says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned about the role of mercury in medicines. "The damage caused by vaccine exposure is massive. It's bigger than asbestos, bigger than tobacco, bigger than anything you've ever seen."

    It's hard to calculate the damage to our country -- and to the international efforts to eradicate epidemic diseases -- if Third World nations come to believe that America's most heralded foreign-aid initiative is poisoning their children. It's not difficult to predict how this scenario will be interpreted by America's enemies abroad. The scientists and researchers -- many of them sincere, even idealistic -- who are participating in efforts to hide the science on thimerosal claim that they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world's poorest populations.

    NOTE: This story has been updated to correct several inaccuracies in the original, published version. As originally reported, American preschoolers received only three vaccinations before 1989, but the article failed to note that they were innoculated a total of eleven times with those vaccines, including boosters. The article also misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms - an amount forty percent, not 187 times, greater than the EPA's limit for daily exposure to methylmercury. Finally, because of an editing error, the article misstated the contents of the rotavirus vaccine approved by the CDC. It did not contain thimerosal. Salon and Rolling Stone regret the errors.

    An earlier version of this story stated that the Institute of Medicine convened a second panel to review the work of the Immunization Safety Review Committee that had found no evidence of a link between thimerosal and autism. In fact, the IOM convened the second panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program, including those raised by critics of the IOM's earlier work. But the panel was not charged with reviewing the committee's findings. The story also inadvertently omitted a word and transposed two sentences in a quote by Dr. John Clements, and incorrectly stated that Dr. Sam Katz held a patent with Merck on the measles vaccine. In fact, Dr. Katz was part of a team that developed the vaccine and brought it to licensure, but he never held the patent. Salon and Rolling Stone regret the errors.

    CLARIFICATION: After publication of this story, Salon and Rolling Stone corrected an error that misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms – an amount forty percent, not 187 times, greater than the EPA's limit for daily exposure to methylmercury. At the time of the correction, we were aware that the comparison itself was flawed, but as journalists we considered it more appropriate to state the correct figure rather than replace it with another number entirely.

    Since that earlier correction, however, it has become clear from responses to the article that the forty-percent number, while accurate, is misleading. It measures the total mercury load an infant received from vaccines during the first six months, calculates the daily average received based on average body weight, and then compares that number to the EPA daily limit. But infants did not receive the vaccines as a “daily average” – they received massive doses on a single day, through multiple shots. As the story states, these single-day doses exceeded the EPA limit by as much as 99 times. Based on the misunderstanding, and to avoid further confusion, we have amended the story to eliminate the forty-percent figure.

    Correction: The story misattributed a quote to Andy Olson, former legislative counsel to Senator Bill Frist. The comment was made by Dean Rosen, health policy adviser to the senator. Rolling Stone and Salon.com regret the error.


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    Vaccine critic faces hearing

    Sun Jul 15, 2007 11:11PM BST

    By Michael Kahn

    LONDON (Reuters) - The doctor who sparked a health scare by suggesting a childhood vaccine against measles, mumps and rubella is linked to autism faces a hearing on Monday into charges of professional misconduct during his research.

    The General Medical Council hearing, expected to last 15 weeks, centres on research published in the Lancet medical journal in 1998 in which Andrew Wakefield and colleagues posited a link between the MMR vaccine and autism.

    The claim led to fierce worldwide debate among researchers and caused a decline in MMR vaccinations that health experts in the UK say has not yet recovered to the level seen before Wakefield's study.

    Scientific evidence suggests that vaccines are not linked to autism but a vocal group of people remain unconvinced.

    Vaccine experts say parents often link vaccines with their children's symptoms because getting a shot can be upsetting, and children are vaccinated at an age when autism and related disorders are often first diagnosed.

    The council will not look into the scientific claims but whether Wakefield and two colleagues -- John Walker-Smith and Simon Murch -- violated a number of ethical practices during the study involving young children.

    "The panel will inquire into allegations of serious professional misconduct by Dr. Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-1998," the group said.

    The council regulates doctors in Britain and could bar the three from practice. It said it would also look into charges Wakefield was involved in advising solicitors representing children claiming to have suffered harm due to the MMR vaccine.

    Wakefield also faces a charge that he acted unethically by taking blood from children at a birthday party after offering them money and without proper ethical approval.

    During the time of the study the three were employed at the Royal Free Hospital. Wakefield now works in the United States and said in a recent interview with the Observer newspaper he plans to defend himself vigorously.

    "My concern is that it's biologically plausible that the MMR vaccine causes or contributes to the disease in many children, and that nothing in the science so far dissuades me from the continued need to pursue that question," Wakefield said.

    Before Wakefield's study, more than 90 percent of children in the United Kingdom received the vaccination, according to government figures. After his warning that figure fell to around 80 percent before rising to 85 percent in 2007.

    The World Health Organisation target is 95 percent, a level that protects the wider population from potential outbreaks and epidemics.

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