Pocketburgers.com: Apr 7, 2008

Here's another figure that might give a small idea of the pharmaceutical industry's global clout --the amount spent on marketing (and "administrative costs") by the 11 biggest drug companies in 2004:

$100 billion

And here's what they reported spending on research and development that year: $50 billion.

When Dr. Marcia Angell stepped down from her post as the edtior-in-chief of the New England Journal of Medicine last year, she published therein a scathing parting-shot takedown of the pharmaceutical industry's impact on contemporary medical practice.

My favorite paragraph is the following, in which she says of the pharmaceutical companies' marketing budgets:

The industry depicts these huge expenditures as serving an educational function. It contends that doctors and the public learn about new and useful drugs in this way. Unfortunately, many doctors do indeed rely on drug-company representatives and promotional materials to learn about new drugs, and much of the public learns from direct-to-consumer advertising. But to rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism.

It's not just doctors and consumers who may be lead astray by these expenditures, however, but the very state and federal regulatory agencies we rely upon to safeguard the public health.

Quoting from government transcripts obtained via the Freedom of Information Act, Robert F. Kennedy Jr. wrote in a 2005 article published in Rolling Stone that:

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.

Verstraeten wasn't alone in expressing concern. The transcripts record Dr. Bill Weil, a consultant for the American Academy of Pediatrics, as saying, "You can play with this all you want,... [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, said "My gut feeling? 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 the conversation didn't then turn to ways to ensure public safety. Dr. Robert Brent, a pediatrician at Delaware's Alfred I. duPont Hospital for Children was more worried about the possibility that, "We are in a bad position from the standpoint of defending any lawsuits. This will be a resource to our very busy plaintiff attorneys in this country."

Dr. Bob Chen, head of vaccine safety for the CDC, chimed in with the assertion 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," adding, "the research results have to be handled," that the results of the study, "will be taken by others and will be used in other ways beyond the control of this group."

Adds Kennedy, at this point:

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 [2004]. 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.

Former Senate Majority Leader Bill Frist, who received $873,000 in contributions from pharmaceutical companies, slipped a "rider" into a Homeland Security bill in 2002, protecting vaccine manufacturers from lawsuits brought by those who suffer vaccine injury--this despite the fact that any vaccine-injury cases ALREADY have to be brought to trial in a special federal Vaccine Court.

Eli Lilly, the company that manufactures Thimerosal, contributed $10,000 to Frist's campaign fund the next day, then bought 5,000 copies of his book on bioterrorism.

Kennedy adds:

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.

But wait, there's more... On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood meeting transcripts.

But what do we read about all of this in the mainstream press? Let's see, there was the study claiming that "autism is caused by drinking during pregnancy" this week, that got global play. Last year it was "autism is caused by watching television."

And there are countless articles in the New York Times and Wall Street Journal assuring readers that "all reputable studies prove there's no link between vaccines and autism," that "autism rates have not gone down since ALL thimerosal was removed from ALL vaccines in 2001" and a great many characterizing concerned parents of autistic children as desperate for someone or something to blame for their children's condition or as lawsuit-hungry money grubbers.

Have autism rates gone down since thimerosal was phased out of vaccines, starting in 2001? Nobody knows. Can you believe that? Seriously, there's been no effort on the part of the CDC or any other federal agency to gather national data on that front.

California is the only state that keeps records of those receiving developmental disabilities services which are categorized by specific disability. It was California's numbers, in fact, which first confirmed what parents had long suspected---and "experts" long denied--that the rate of autism among young children in this country started skyrocketing in the 1990s.

If California's rates went down, that might be an indicator that removal of thimerosal was making some kind of a difference, right?

Let's just ignore the Associated Press article published in 2005 that announced "The number of new cases of autism in California has fallen for the first time in more than 10 years in what may be a bellwether for autism rates nationwide, according to new data compiled by the state Department of Developmental Services."

Everyone else ignored it, after all. And any parent who tries to bring it up is branded a crazed Luddite, or worse.

Michelle Malkin, with whom I don't always see eye-to-eye politically except on this topic, blogged "In defense of parents with informed vaccine skepticism" on March 24th:

The New York Times published a piece today about parents choosing not to expose their children to certain vaccines. This prompted blogger condemnations of those parents as “Bobo sociopaths” and a recommendation from Glenn Reynolds that “we should make clear that parents who, with no genuine medical reason, forego vaccinating their kids are bad parents, and bad citizens.”

Look, I could run you through the flaws in the studies routinely cited in that type of article (the Danish one, the Israeli one, etc.), or the differences in the way ethyl and methyl mercury break down in the body (not many), or the still-toxic and untested preservatives that have replaced thimerosal in multi-dose vials of vaccines, or the study performed at Columbia on the aberrant behaviors of infant mice injected with thimerosal, or the similarities in symptoms between autism and mercury poisoning,

or the fact that among thousands of Amish people in Pennsylvania (virtually non-vaccinated, as a population) only a handful of kids were found with any form of autism--one who'd been adopted in China and three who'd received vaccinations--when the expected number per that population would be around 130 affected individuals, or the hypothesis that autistic kids may lack the proper metabolic apparatus to excrete heavy metals as quickly as "typically developing" kids, or statistics on how much mercury is still in a number of shots administered routinely to infants and children and pregnant women (flu, tetanus, Rhogam, etc.)--because that's my version of the genius investor's "cabbages and sailing," these days....
(please run your mouse over the text of the previous two paragraphs to click through to studies cited--for some reason the hyperlinks aren't highlighted)

But I don't want to bore you any more than necessary, and besides, as a "bad parent and bad citizen," I'll let Kennedy speak to the history of the issue instead:

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."...

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."

And now I'd like to quote some numbers recently put forth by a toxicologist named Michael F. Wagnitz, in a rebuttal letter to the editors of Pediatrics, the journal of the American Academy of Pediatrics.

Wagnitz introduced his list by writing, "Parents get angry when they see the following numbers listed on the internet. These numbers have been out there for everyone to read for years."

Here are the numbers he cited:

0.5 parts per billion (ppb) mercury = Kills human neuroblastoma cells (Parran et al., Toxicol Sci 2005; 86: 132-140).

2 ppb mercury = U.S. EPA limit for drinking water http://www.epa.gov/safewater/contaminants/index.html#mcls

20 ppb mercury = Neurite membrane structure destroyed (Leong et al., Neuroreport 2001; 12: 733-37).
200 ppb mercury = level in liquid the EPA classifies as hazardous waste. http://www.epa.gov/epaoswer/hazwaste/mercury/regs.htm#hazwaste

25,000 ppb mercury = Concentration of mercury in the Hepatitis B vaccine, administered at birth in the U.S., from 1990-2001.

50,000 ppb mercury = Concentration of mercury in multi-dose DTaP and Haemophilus B vaccine vials, administered 4 times each in the 1990's to children at 2, 4, 6, 12 and 18 months of age. Current "preservative" level mercury in multi-dose flu (94% of supply), meningococcal and tetanus (7 and older) vaccines. This can be confirmed by simply analyzing the multi- dose vials.

Oh yeah, I forgot to mention that Wagnitz has a conflict of interest: he's the father of an autistic child.

Way back near the beginning of this post, remember how I said that something happened this month which made me feel it was necessary to at long last write a blog post on, as it turns out, thimerosal?

Here's the event I spoke of: the government decided in favor of the plaintiffs in one of the first Vaccine Injury Court autism test cases to go to trial.

That's right, folks, a judge representing the United States government decided that the family of an autistic girl was entitled to a monetary award, because it indeed seens evident that her condition was caused by "routine childhood vaccinations."

The anti-vaccine-hypothesis gang got started on spinning the verdict immediately--most by claiming that the girl, Hannah Poling, wasn't "typical" of autistic children, in that she had a metabolic disorder exacerbated by vaccines, and that therefore the metabolic disorder is itself responsible for her "autistic symptoms."

There are still nearly 5,000 such cases pending in the special court. I would be cynical if I thought that might have something to do with the intensity of the spin.

And yet... the online version of Time magazine had the courage to look at the facts of the case without the disimissive attitude so many of us have come to expect from the "mainstream" media, in an article titled “Case Study: Autism and Vaccines.”

The piece opened as follows:

What happened to little, red-haired Hannah Poling is hardly unique in the world of autism. She had an uneventful birth; she seemed to be developing normally-smiling, babbling, engaging in imaginative play, speaking about 20 words by 19 months. And then, right after receiving a bunch of vaccines, she fell ill and it all stopped.

Hannah, now 9, recovered from her acute illness but she lost her words, her eye contact and, in a manner of months, began exhibiting the repetitive behaviors and social withdrawal that typify autism. “Something happened after the vaccines," says her mom, Terry Poling, who is a registered nurse and an attorney. “She just deteriorated and never came back."

Hannah Poling's father, by the way, is a neurologist.

Here's one official's response to the court's ruling in the Poling case:

"Our message to parents is that immunization is life-saving," Dr. Julie L. Gerberding, the CDC's director, said at a hastily convened conference call with reporters.

"There's nothing changed. . . . This is proven to save lives and is an essential component of protection for children across America and around the world."

Gerberding further commented:

“Let me be very clear that (the) government has made absolutely no statement indicating that vaccines are a cause of autism. That is a complete mischaracterisation of the findings of the case, and a complete mischaracterisation of any of the science that we have at our disposal today.”

The Time article, however, went on to say:

...there’s no denying that the court’s decision to award damages to the Poling family puts a chink--a question mark--in what had been an unqualified defense of vaccine safety with regard to autism. If Hannah Poling had an underlying condition that made her vulnerable to being harmed by vaccines, it stands to reason that other children might also have such vulnerabilities.

As blogger Kent Heckenlively wrote in response to the article "I found myself nodding along as I read, saying, 'Yes! Yes! They’re getting it!'”

"One of the final paragraphs [in the article] is a statement which shouldn’t be controversial," he continues, "but when our community has said similar things we’ve been treated like we were primitives who wanted to take public health back to the nineteenth century." (And/or "bad parents," "bad citizens," "Bobo Sociopaths.")
Here's the paragraph he's referring to:

It’s difficult to draw any clear lessons from the case of Hannah Poling, other than the dire need for more research. One plausible conclusion is that pediatricians should avoid giving small children a large number of vaccines at once, even if they are thimerosal-free. Young children have an immature immune system that’s ill-equipped to handle an overload, says Dr. Judy Van de Water, an immunologist who works with Pessah at U. C. Davis. “Some vaccines, such as those aimed at viral infections, are designed to ramp up the immune system at warp speed,” she says. “They are designed to mimic the infection. So you can imagine getting nine at one time, how sick you could be.” In addition, she says, there’s some evidence, "that children who develop autism may have immune systems that are particularly slow to mature.”

"It’s stunning to read a paragraph like the one above in a major publication like TIME magazine," says Heckenlively, "when it’s been part of the catechism of our movement for years. It’s as if we’ve been secret believers in God in some totalitarian state and the ruler just announced he’s considering a conversion."

He also cites a report titled, "Vaccine Case - An Exception or a Precedent," from the CBS Evening News broadcast that aired on March 6, 2008, in response to the CDC having stated that Hannah Poling's case is "a singular event":

While the Poling case is the first of its kind to become public, a CBS News investigation uncovered at least nine other cases as far back as 1990, where records show the court ordered the government to compensate families whose children developed autism or autistic-like symptoms... including toddlers who had been called "very smart" and "impressed" doctors with their "intelligence and curiousity" . . . until their vaccinations.

But even if all those remaining cases pending in the Vaccine Court are ruled in favor of the plaintiff families, it doesn't mean that the families of the other estimated 500,000 kids with autism in this country will be able to sue for damages, under existing legislation. The federal government has set a three-year statute of limitations, dating from the first incidence of autistic symptoms in a child.

In light of that, I'd like to close this post with one more quotation from Dr. Marcia Angell's "farewell" editorial in the New England Journal of Medicine:

The pharmaceutical industry is extraordinarily privileged. It benefits enormously from publicly funded research, government-granted patents, and large tax breaks, and it reaps lavish profits. For these reasons, and because it makes products of vital importance to the public health, it should be accountable not only to its shareholders, but also to society at large.

May that sentiment go from Angell's lips to God's ears. And possibly Julie Gerberding's.

And look, maybe it's not the vaccines or the thimerosal that made the rate of autism go from one kid in 15,000 to one kid in 116. It could be some new additive in peanut butter, or exposure to wheat bran and Sea Monkeys.

I mean, until the mid-Seventies the "experts" claimed it was caused by overly intellectual, emotionally distant "refrigerator mothers."

We know, at least, that that last hypothesis is a load of crap. But we don't know anything else.

Isn't it time we expended a little more effort trying to really figure this thing out, and a little less of same calling the parents who are doing their best to make sense of and cope with the horrors of this disorder idiots?

I can't speak for anyone else, but I'm pretty fucking sick of being told how stupid I am.

I won't hold my breath waiting for that to change any time soon.

Meanwhile: smoke 'em if you got 'em.