Thursday, February 26, 2009

Questioning Vaccines in a Nutshell

If I could sum up in a concise list some of the reasons I don't have absolute trust in the vaccine program anymore, this is it. I may add to this list in the future, but for now, this was a quick list I jotted down to highlight my major concerns.

1. There is too much money at stake for pharmaceutical companies, which lobby Congress and are intricately involved in the nation's public health bodies (According to a 2/23/09 article in The Wall Street Journal, vaccines will generate $21.5 billion in annual sales by the year 2012). They also have an unsettling amuont of control over vaccine studies in scientific journals, as recently reported in the British Medical Journal.

2. Thimerasol (mercury) was used in vaccines for years (and is still in the flu shot, as far as I know) and was given to children in their shots sometimes in levels over 100 times the EPA allowable "safe" limit. The government denies that there is any link between neurological disorders and the neurotoxin mercury given to children in shots. (Read the book Evidence of Harm by David Kirby for the story of parents who discovered their kids were poisoned by mercury and have been ostracized by the medical community.)

3. There exists much information about harm from vaccines in medical journals, but we, the public, don't have the privilege of hearing about it like we do for most other pharmaceuticals.

4. The government had no tracking system in place to monitor adverse events from vaccination until parents of vaccine-injured children lobbied for it (The National Childhood Vaccine Injury Act of 1986). See the "History of NVIC" section on this page for a brief summary.

5. The government's tracking system for vaccine injury (VAERS) cannot assess causality and there is under-reporting to VAERS. Thus, there is no real paper trail for determining how many children are adversely affected by vaccines, or even if the vaccine caused their problems or not. To me, this is inexcusable. If the government wants me to use these products, it needs to know. Here again, it seems the medical community is in no hurry to protect children from vaccine injury, dismissing problems as "coincidence" all too often.

6. After recognizing a biological marker (a mitochondrial disorder) that supposedly set Hannah Poling up for regressing into autism after vaccination, the CDC was not concerned enough to start screening children for mitochondrial disorders. They said this would be risky, expensive and would raise "ethical questions." To me, this says that protecting kids from vaccine injury is not as important as protecting the vaccine program. Autism is also risky and expensive, and it raises ethical questions for me regarding why the CDC would rather risk my kid getting autism than risk not vaccinating. (See "CDC Responds to Questions About Vaccines," March 28, 2008)

7. The government has never done a comprehensive study on the overall health of vaccinated kids versus unvaccinated. Yet a parents group, Generation Rescue, conducted a survey of 17,674 children in California that found that vaccinated boys compared to unvaccinated boys were 155% more likely to have a neurological disorder, 224% more likely to have ADHD and 61% more likely to have autism. Though this can't substitute for in-depth scientific studies and cannot point to definite conclusions, I wonder then, why won't the CDC take on the responsibility of doing this? We need answers. I think the CDC is afraid that they will find the same things, or worse, and have to deal with answering for a public health disaster.

Boy, this really takes time. Motherhood calls! Perhaps more on this later.

Wednesday, February 25, 2009

Wall Street Journal on the Vaccine Court

I plan to write a "Top Ten" list of sorts for this blog one day. Sort of a "why I question vaccines" nutshell to pull out of pocket, oh, I don't know, at family gatherings or the church picnic. *Ahem* ... alright, that's kind of a joke, since vaccine conversations are usually controversial and not particularly socially acceptable... But, the idea is that I have several valid reasons for this research, many of which point to the question of "Can I trust the government for vaccine safety?" The vaccine court is one major reason I often find myself answering, "No."

Just as a general piece of information on the vaccine court, I am posting an article that appeared in The Wall Street Journal on Feb. 23rd, titled "Vaccine Makers Enjoy Immunity." (You have to subscribe to the Journal to read the whole thing, but some smart person - thanks, Jim - posted a bit more of the content on Age of Autism, which is where I read about the article in the first place.) The comment trail on the Age of Autism blog also contains some very good nuggets of information and is worth a read.

From The Wall Street Journal, 2/23/09:

One of the little-noticed reasons that Wyeth was attractive enough to command a $68 billion price for rival Pfizer Inc.'s planned takeover sits in a building catty-corner from the White House across Pennsylvania Avenue. That is where a special "vaccines court" hears cases brought by parents who claim their children have been harmed by routine vaccinations.
The court -- and the law that established it more than two decades ago -- buffers Wyeth and other makers of childhood-disease vaccines from much of the litigation risk that dogs traditional pill manufacturers and is an important reason why the vaccine business has been transformed from a risky, low-profit venture in the 1970s to one of the pharmaceutical industry's most attractive product lines today.
The legal shield, known as the National Childhood Vaccine Injury Compensation Program, was put into place in 1986 to encourage the development of vaccines, a mainstay of the nation's public-health policy. A spate of lawsuits against vaccine makers in the 1970s and 1980s had caused dozens of companies to get out of the low-profit business, creating a public-health scare.
The strategy worked and the public-health implications have been sizable. Vaccines have driven huge reductions -- and in the case of smallpox, for instance, complete eradications -- of major childhood diseases. Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia, who developed a vaccine for rotavirus with Merck & Co., says, "If that Act didn't happen, I think American children would have been at risk."
Vaccines have also become big business. They are poised to generate $21.5 billion in annual sales for their makers by 2012, according to France's Sanofi-Aventis SA, a leading producer of inoculations.
At a time when pharmaceutical companies are being battered by generic competition to their best-selling drugs, vaccines offer an appealing alternative because they are biologic products that can't yet be copied. Another big draw is the partial protection from liability risk offered by the vaccines court, officially known as the Office of Special Masters at the U.S. Court of Federal Claims.
Such immunity makes a product like Wyeth's Prevnar enormously attractive. Designed to protect children against seven strains of pneumoccocal disease, Prevnar had sales of $2.7 billion last year that are projected to grow to $5.5 billion in 2015, according to Sanford C. Bernstein & Co.
Pfizer spokesman Ray Kerins acknowledges that Wyeth's strength in vaccines was an important factor behind Pfizer's interest in the company, but he adds that the deal made sense for a number of other reasons.
Vaccines' transformation into a lucrative business has some observers questioning whether the shield law is still appropriate. Critics say the vaccine court's ruling this month that routine childhood immunizations aren't linked to autism underscored the limited recourse families have in claiming injury from vaccines.
"When you've got a monopoly and can dictate price in a way that you couldn't before, I'm not sure you need the liability protection," said Lars Noah, a specialist in medical technology at the University of Florida's law school who has written about vaccines.
Many plaintiffs' lawyers would prefer to take their lawsuits directly to civil court because the vaccine court limits compensation in death cases to $250,000. They also think that juries could give them a more sympathetic hearing.
Kevin Conway, an attorney at Boston law firm Conway, Homer & Chin-Caplan PC, which specializes in vaccine cases and brought one of the recent autism suits, says the lack of liability for the pharmaceutical industry compromises safety.
"The dire straits of the 1980s do not exist anymore and it calls into question the need for the program, since the ability to sue the pharmaceutical companies would provide a different level of oversight," Mr. Conway says.
Even if they had won their cases, the families of autistic children wouldn't have been paid by the companies that make the vaccines, as is common in other pharmaceutical-liability cases. Instead, the government would have footed the bill, using the funds from a tax levied on inoculations.
The pharmaceutical industry, for its part, argues that the vaccine shield is still necessary. "The Act remains an important and relevant protection against baseless litigation that may dissuade parents from having their kids receive important vaccines," says Wyeth's outside counsel for vaccine litigation, Daniel Thomasch, of Orrick, Herrington & Sutcliffe LLC.
Mark Feinberg, vice president for medical affairs and policy at Merck's vaccine division, says companies need the government's protection to shoulder the risk of pricey clinical trials. "Today, there are a number of important infectious diseases that don't have vaccines," he says. "The program does provide clarity for manufacturers as they go forward with new development."
To be sure, the vaccine court has been friendly to some plaintiffs. About $970 million has been awarded in its two decades of existence, and 12,890 cases have been filed. The court has relaxed standards about which witnesses and evidence can be admitted, because its judges -- called special masters -- are better equipped to navigate dubious science than a jury.
And injured parties can still sue vaccine makers in civil court if they reject the vaccine court's decision, if the court dismisses the claim or if the claim is stalled in the court for more than 240 days. Rep. Henry Waxman, who introduced the 1986 bill, hails those limits to the liability shield. "Vaccines are products that are completely different from any others. We need to encourage companies to develop vaccines in order to protect the public health," he says. "The manufacturers have long fought for total immunity from lawsuits, but I have fought back hard to ensure that the law preserves access to courts in cases of true negligence or misconduct."
But vaccine suits, when they do get to civil court, face restrictions there on punitive damages and failure-to-warn arguments.
Barbara Loe Fisher, the co-founder of a nonprofit parents' group called the National Vaccine Information Center, says the inclusion of high-priced new vaccines, like Merck's Gardasil, which aren't vital to preventing pandemics, runs counter to the spirit of the original law, which she worked on in the 1980s.

Thursday, February 12, 2009

Government Rationed (er, Controlled) Health Care

[EDIT 2/25/09: The American Recovery and Reinvestment Act of 2009 is now law, as everyone with a TV, radio or computer has surely heard. I was not able to find anything saying the health care provisions had been removed. In his State of the Union address last night, President Obama made it clear that he wants health care reform to happen this year. Hopefully the majority will allow the people to know what's going on, and we can debate whether or not we want government doing comparative research and making decisions for us.]

Yesterday, the Senate passed the economic stimulus bill, and with it, provisions to move our country toward socialized (government-run) medicine. These provisions are frightening on many levels, and if Americans actually had a chance to vote on this, its failure would be sure. Instead, the majority in the House and Senate are trying to rush it through under the cover of night and get it quickly to President Barack Obama for signature.

The Heritage Foundation's Nina Owcharenko summarizes it this way: "Veiled under this massive economic stimulus proposal are profoundly controversial and far-reaching health care provisions that would set the country on a path toward more fiscal irresponsibility, mounting unfunded entitlement liabilities, and less control of families over their personal health care decisions." She explains that the bill would "establish a framework and funding for comparative effectiveness research and health information technology," which would open a portal to "direct government intervention in the clinical decisions by physicians and other health care providers."

To read more of the Heritage Foundation article, click
here. You can also find more articles at, such as this one by Rep. John Shadegg (R-Arizona). This article is also informative. According to Tom Daschle (whose handiwork is reflected in the provisions), doctors have to give up autonomy and "learn to operate less like solo practitioners," the article reports.

For anyone who cares about freedom of medical decisions and doesn't want the government making personal health choices for them, this "economic stimulus" package is impossible to support in its current form. It is of utter importance that as many Americans hear about these provisions and make phone calls and send emails to the Hill. The Capitol Switchboard number is 202-224-3121 (you'll need to tell the operator where you're from so he/she can connect you) and you can use the
House and Senate Web sites to look up direct numbers or email addresses for your representatives. Please spread the word.

One Congresswoman who is in the minority party has started a blog to keep us folks "outside the beltway" up to date on happenings on the Hill. I look forward to seeing if it actually turns out to be useful! You can check out her blog here:

To put it like one blog commenter said, "I have a hard time thinking of anything that the government runs better than the private sector." Who is a better decision-maker for your health care than you and your doctor? What about for your children? People living in countries where health care is run by the government would gravely warn us about falling into this trap. Please act.

Sample E-mail (thanks to Nina Owcharenko's article for some of the wording!) to your reps:
Dear ______,
I am writing today to urge you to please do your part to remove or revise the health care provisions in the economic stimulus bill. I ask you to please remove the funding for the comparative effectiveness and health information technology. If Congress wants to enact such provisions, it should do so not tagged on a fast-tracked stimulus bill but with a full and public debate so that the American people understand the impact of these health care decisions on their lives. Any other course would be a betrayal of the President's promise of openness with American people.
Please do not allow this great nation of ours, where personal freedom and entrepreneurship are beacons of our heritage, to move toward socialized medicine. This is not the right direction for the American people.

Gardasil Battle Continues; 29 deaths reported so far

From the National Vaccine Information Center:

NVIC Vaccine Risk Report Reveals More Serious Reaction Reports After Gardasil

Vaccine Safety Group Calls for Investigation
BUSINESS WIRE)--Comparing serious adverse event reports to the federal Vaccine Adverse Events Reporting System (VAERS) following Gardasil (HPV) and another vaccine for meningococcal (Menactra), the National Vaccine Information Center ( found that there are three to 30 times more serious health problems and deaths reported to VAERS after Gardasil vaccination. As reported by CBS News, the longtime vaccine safety watchdog group is calling for action, including an investigation by the Department of Health & Human Services (DHHS) and the U.S. Congress into the fast-tracked licensure and government recommendation that all young girls and women get Gardasil vaccine.

“Merck only studied the vaccine in fewer than 1200 girls under age 16 and most of the serious health problems and deaths in the pre-licensure clinical trials were written off as a 'coincidence,'” said NVIC co-founder and president, Barbara Loe Fisher. “If the new Administration and Congress want to make government recommended health care safer, more effective and less expensive, a good place to start is by looking into the human and economic costs of Gardasil vaccine.”

Gardasil and Menactra vaccines are recommended by the Centers for Disease Control (CDC) for gradeschool, high school and college age children, although Gardasil is only given to girls while Menactra is given to both girls and boys. If reports of Gardasil vaccine-related adverse events are only coincidental as maintained by
CDC officials in October 2008, there would be little or no difference in the number and severity of adverse event reports for both vaccines.

Using the
MedAlerts database, compiling data for VAERS through November 30, 2008, NVIC found that compared to Menactra, Gardasil is associated with at least twice as many Emergency Room visit reports (5,021), four times as many Death reports (29); five times as many “Did Not Recover” reports (2,017) and seven times as many “Disabled” reports (261). There have been 34 reports of thrombosis, 27 reports of lupus, 23 reports of blood clots, 16 reports of stroke, and 11 reports of vasculitis following Gardasil vaccine given alone without any other vaccines. There are three to six times more fainting or syncope reports after Gardasil vaccination than after Menactra and there have been 544 reports of seizures following Gardasil and 158 after Menactra (73 Menactra-associated seizures involved co-administration with Gardasil).

Rechallenge reports to VAERS involve cases where there was a worsening of symptoms after repeated vaccination. There were 275 Rechallenge reports after Gardasil compared to eight after Menactra (7 Menactra-associated Rechallenge reports involved co-administration with Gardasil). In the entire VAERS database for all vaccine adverse event reports, there are 467 rechallenge reports, of which nearly 60 percent are for Gardasil.

A 15-year old gymnast, cheerleader and honor roll student in Kansas has been diagnosed with Gardasil vaccine-related brain inflammation after receiving three Gardasil shots. Her first symptoms included muscle and joint weakness and pain, numbness and tingling in her hands and feet, severe headaches excessive fatigue, rash, dizziness, and loss of concentration after the first shot. After the second and third shots she began losing her hair and developed seizures, bouts of paralysis, mini-strokes, partial loss of vision, and severe chest pain, memory and speech loss. Click here to
learn more.

A 21-year old Maryland artist, athlete and honor roll college student died suddenly without explanation in June 2008 after her third Gardasil shot. She is one of the 29 Gardasil death reports in VAERS. Click here to
learn more.

A nonprofit, non-medical organization founded by parents of vaccine injured children in 1982, NVIC
issued three VAERS analyses in 2007 warning that Gardasil appeared to be highly reactive and asking for federal health agencies to inform physicians and parents about serious health problems associated with the new vaccine.