Victory for Veterans/ NY Times Editorial

From the NY Times' editorial page:

The United States Court of Appeals for the Ninth Circuit ordered an overhaul of mental health care for veterans, who are killing themselves by the thousands each year because of what the court called the “unchecked incompetence” of the Department of Veterans Affairs.

... delays in treating post-traumatic stress disorder and other combat-related mental injuries violated veterans’ constitutional rights. The delays are getting worse as more troops return from Afghanistan and Iraq, the judges said. About 18 veterans commit suicide on an average day.

... The judges said the system for screening suicidal patients was ineffective, and cited a 2007 inspector general’s conclusion that suicide-prevention measures were mostly absent. The same report found that the veterans department’s regional medical centers have suicide-prevention experts, but its 800 community-based outpatient clinics — which veterans most often use — do not. This crisis plagues active-duty soldiers, too, and the Pentagon has lagged in responding effectively. The government has long known what it was up against with P.T.S.D. and brain injuries — the signature afflictions of current wars...

Dominique Strauss-Kahn was pushing for increased bank regulations and more even income distribution worldwide/ Washington Post

UPDATE:  Dominique Strauss-Kahn is "not in a position to run" the International Monetary Fund after his arrest over an alleged sexual assault, US Treasury Secretary Timothy Geithner has said.  May we remind Mr. Geithner that he was guilty of tax evasion, yet he runs the US Treasury, responsible for collecting taxes.  What was good for the goose is not good for the gander.  But some have no shame.

Meanwhile, IMF deputy director John Lipsky will run the IMF.  Lipsky is formerly of the US Treasury and of JP Morgan.  No doubt more predictable, especially after viewing the lesson provided to DSK.

Let me make clear, I do not condone rape.  This case interests me simply because it was handled so differently from the usual case of diplomats gone wrong, such as in a vehicular homicide, or the aforementioned incident in Pakistan.  Who denied Strauss-Kahn the niceties that normally accompany his position, and why?  That is the interesting question here, and media have failed to ask it.

The April 11, 2011 Washington Post had an interesting piece about new directions at the IMF, led by DSK.  One has to wonder if this helped lead to the crisis in which DSK now finds himself, entirely stripped of dignity, being tortured (a la Bradley Manning, who was put on suicide watch as a way to enhance his psychological torture--with clothes and personal items removed, lights on 24/7) and pilloried around the world.  Read the following and see the threat he posed to the banks that now own and run our little planet.

Since the Wall Street bank Lehman Brothers failed more than two years ago, bringing the global economy to the brink of collapse, countries have spent hundreds of billions of dollars to prop up their markets, intensified regulation of financial companies and deepened government involvement in the economy.

For International Monetary Fund managing director Dominique Strauss-Kahn, the job is only half done, as he has been leading the fund through a fundamental rethinking of its economic theory. In recent remarks, he has provided a broad summary of the conclusions: State regulation of markets needs to be more extensive; global policies need to create a more even distribution of income; central banks need to do more to prevent lending and asset prices from expanding too fast.

“The pendulum will swing from the market to the state,” Strauss-Kahn said in an address at George Washington University last week. “Globalization has delivered a lot . . . but it also has a dark side, a large and growing chasm between the rich and the poor. Clearly we need a new form of globalization” to prevent the “invisible hand” of loosely regulated markets from becoming “an invisible fist.”
The effort to recast global economics will be a focus of IMF meetings this week...

The growing income gap between the rich and poor is no longer seen by many inside the IMF as a by-product of economic boom times but a cause of crisis, as poor and middle-income families turn to borrowed money to make up for stagnant incomes.

Strauss-Kahn continues to push for major new financial sector taxes, although that issue has never gained broad support. He has been frustrated as well in advocating an international program to ensure that the most globally connected financial firms can be put out of business if needed without costing taxpayers. That would require a deeper level of cooperation among nations than exists...

The IMF has also revised its long-standing opposition to “capital controls“ and researching ways that nations could control risky behavior by financial firms.
Strauss-Kahn — who is in the fourth year of a five-year term at the IMF and is being mentioned as a possible Socialist Party candidate in upcoming French presidential elections — said any suggestion that the fund is pushing for too much government is off the mark. The financial crisis is evidence, he said.
“There is a long way to go before all that has been badly done by the lack of supervision of the market will be overcome,” he said. “The whole public sphere has to do more.”

Cores Damaged at 3 Reactors/ WSJ

Partial meltdowns of three reactors and breaches of the containment vehicles are finally acknowledged by TEPCO on May 15.  From the WSJ:

Substantial damage to the fuel cores at two additional reactors of Japan's Fukushima Daiichi nuclear complex has taken place, operator Tokyo Electric Power Co. said Sunday, further complicating the already daunting task of bringing them to a safe shutdown while avoiding the release of high levels of radioactivity. The revelation followed an acknowledgment on Thursday that a similar meltdown of the core took place at unit No. 1...

Ban mobile phones and wireless networks in schools, say European leaders/ The Telegraph

I attended the European Bioelectromagnetics meeting in Helsinki in September 2001, and discovered then that there were dueling bodies of evidence regarding whether electromagnetic fields from cell phones or other sources caused adverse health effects.  Things have not changed a lot since then, although the body of research has considerably expanded.  Because the research paid for by industry found EMFs to be safe, and independent research frequently found them harmful, attempts to regulate EMFs have gone nowhere in the US.  In fact, no one at EPA is charged with investigating or regulating EMFs.

Things appear to be different in the EU.  There, a report dated May 6, 2011, titled The potential dangers of electromagnetic fields and their effect on the environment has made recommendations to reduce exposure to certain fields, such as those from cell phones, especially in children.  It is a breath of fresh air to have an official body acknowledge the utility of the precautionary principle.

From the Telegraph:

A Council of Europe committee examined evidence that the technologies have "potentially harmful" effects on humans, and concluded that immediate action was required to protect children.

In a report, the committee said it was crucial to avoid repeating the mistakes made when public health officials were slow to recognise the dangers of asbestos, tobacco smoking and lead in petrol...

The committee concluded that member states should:

• Set thresholds for levels of long-term exposure to microwaves of the type emitted by mobile phones;
• Introduce clear labelling on products indicating the presence of electromagnetic fields and any health risks associated with use;
• Ban all mobile phones and wireless networks in classrooms and schools;
• Run information campaigns aimed at children and young adults about the risks to human health;
• Step up research on less-dangerous types of antennae and mobile phones.

The conclusions contradict advice from the World Health Organisation and the Department of Health, which says exposure to electromagnetic fields poses little or no risk to human health.
The Council of Europe, which has 47 member states and is based in Strasbourg, cannot impose its will on governments, but is highly influential in policy-making and has often seen its decisions enacted through conventions and treaties.
A draft resolution – calling on governments to "take all reasonable measures to reduce exposure to electromagnetic fields" from mobile phones and similar devices, including the ban in schools – was adopted unanimously by the organisation's Committee on the Environment, Agriculture and Local and Regional Affairs.
The committee is composed of 84 MPs and politicians from member states, and its vice-chairman is Lord Prescott, the former Deputy Prime Minister. Its members reviewed the latest research on the effects of electromagnetic fields and took fresh evidence from experts before reaching its conclusions...

I.M.F. Chief’s Arrest Throws French Politics Into Disarray/ NYT

UPDATE:  I was reminded that a fellow named Raymond Davis, a CIA contractor (formerly of Blackwater/Xe) shot two Pakistanis on motorcyces to death in February.  President Obama claimed he was "our diplomat"and insisted Pakistan grant him immunity under the Vienna Convention on diplomatic immunity of 1961.  Davis had a car full of weapons, disguises and other questionable material when arrested in Pakistan.

But the French head of the IMF, a UN agency, has been granted no immunity while over here.  Wasn't even given bail.  Is sitting in a cell at Riker's Island's notorious jail.  Hello?

From the NY Times and every other major world outlet:

For months, France has been buzzing with speculation that Dominique Strauss-Kahn, the popular chief of the International Monetary Fund, would quit his job in Washington to take on President Nicolas Sarkozy in next year’s presidential elections. But on Sunday, French politicians and media met news of his arrest in New York for alleged sexual aggression with stunned disbelief and expressions of national humiliation.  The incident threw Mr. Strauss-Kahn’s political party, the Socialists...

The head of France’s Christian Democratic party, Christine Boutin, went further, suggesting that amid the atmosphere of France’s presidential campaign, Mr. Strauss-Kahn may have been set up.   “I really believe that somebody set a trap for Dominique Strauss-Kahn to fall into,” she told French television. “That he could be taken in like that seems astounding, so he must have been trapped.” 

Of great interest, IMF staff have diplomatic immunity.  There is discussion of how much immunity they receive:  for only official acts or for everything?  From the OpinioJuris site:

... the Secretary General and Assistant Secretaries General of the UN, senior OAS officials get the same privileges and immunities as diplomats, meaning that they are absolutely immune in almost all cases from criminal arrest or civil suit.  And, at least some members of the IMF get this treatment as well.  The IMF is a specialized agency of the United Nations and the United Nations and the United States have a long-standing “Headquarters Agreement” that governs U.S. treatment of UN representatives and personnel. Article 15 of that agreement provides that:

“principal resident representatives of members of a specialized agency and such resident members of the staffs of representatives of a specialized agency as may be agreed upon between the principal executive officer of the specialized agency, the Government of the United States and the Government of the Member concerned, shall whether residing inside or outside the headquarters district, be entitled in the territory of the United States to the same privileges and immunities, subject to corresponding conditions and obligations, as it accords to diplomatic envoys accredited to it.”

Thus, if DSK were a “principal resident representative” (PRR) of the IMF, he might actually be immune from arrest entirely...

The fact that Strauss-Kahn was arrested so quickly, despite tricky legal matters of diplomatic immunity and a potential international incident, in NYC, home to the United Nations, where police are used to handling such delicate matters delicately, suggests that police may have received their marching orders from a higher authority, possibly even before the incident occurred.  The fact that the story made the headlines within hours also suggests the incident was handled outside usual diplomatic protocols.  

UPDATE:  From a later NY Times piece:

Well before Mr. Strauss-Kahn’s arrest there had been reports that Mr. Sarkozy was gathering information to discredit Mr. Strauss-Kahn should he run for president. In a famous incident, reported by the news magazine Le Point, Mr. Strauss-Kahn confronted Mr. Sarkozy in the men’s room at the Group of 20 summit meeting in Pittsburgh in September 2009, saying: “I’ve had more than enough of this continued gossip about my private life and about supposed dossiers and photos that could come out against me. I know that this is coming from the Élysée. Tell your guys to stop or I’ll go to the courts.”

UPDATE:  DSK placed on suicide watch, under 24/7 surveillance. 

Helicopter at death scene: Can the David Kelly suicide get any more bizarre?/ Daily Mail

While the world waits for UK Attorney General Dominic Grieve to decide whether to hold an inquest into Dr. Kelly's death, accruing information makes the suicide theory less and less tenable.  A helicopter, hired by Thames Valley police, landed at the scene 90 minutes after Kelly's body was discovered, stayed 5 minutes, then left.  Another scoop from the Daily Mail:

Details from its flight log, released under the Freedom of Information Act, show that the helicopter – hired by Thames Valley police – landed at Harrowdown Hill in Oxfordshire at 10.55am on July 18, 2003, 90 minutes after the body was discovered by volunteer search teams.

Significantly, the flight log has been heavily redacted, making it impossible to know who was on board or what its exact purpose was.

The flight was not mentioned in oral evidence at the Hutton Inquiry, set up by Tony Blair to investigate Dr Kelly’s death...

The riddle joins the growing list of unanswered questions about the circumstances of the government weapons inspector’s final moments.  

It emerges in the same week that Tony Blair and Alastair Campbell were accused of lying to the Chilcot Inquiry into the lead-up to the Iraq war.

The Mail reported yesterday how declassified documents from the inquiry revealed a spy chief disputed Campbell’s claim that the dossier was ‘not the case for war’.  

According to Major-General Michael Lurie, ‘We knew at the time that the purpose of the Dossier was precisely to make a case for war, rather than setting out the available intelligence. I and those involved in its production saw it exactly as that, and that was the direction we were given... ‘During the drafting of the final Dossier, every fact was managed to make it as strong as possible, the final statements reaching beyond the conclusions intelligence assessments would normally draw from such facts.

Called to give evidence behind closed doors, General Laurie was asked if the dossier gave the public ‘a false picture’ of the intelligence. He replied: ‘Yes, yes, yes.’

See the Daily Mail piece for "Ten Unanswered Questions."

Evidence not previously mentioned in this blog includes the fact Dr. Kelly booked a return flight to Iraq (for work) the morning he died, and had an appointment to meet one of his daughters later that day.

$15,000 first prize for flu vaccine app/ CDC

Take the Flu App Challenge!

"Applications and technology make it easier to communicate critical information about the flu and its impact. We’re looking for an innovative use of technology to raise awareness of influenza and/or educate consumers on ways to prevent and treat the flu."

Software innovators, you have until May 27 to submit your app.  Good luck!

Flu: What are the Stats?/ CDC data

The 2010-11 flu season is now over.  Where do we stand in terms of vaccination and deaths from flu?

The influenza vaccine is said to have been a good match to the majority of strains that circulated during this flu season.

One hundred two (102) pediatric deaths were reported to CDC from the entire US for the flu season just finished.  This compares to 88 deaths for 2007-8, 133 deaths for 2008-9, 282 deaths for 2009-10 (when swine flu caused a prolonged season of influenza infection from May 2009 through spring 2010), and the aforementioned 102 deaths for the 2010-11 season just ended.  CDC reports that 51% of children hospitalized for influenza had no underlying chronic illnesses, while 49% had a preexisting chronic disease.

How many people died from influenza?  CDC reported deaths from flu in the US totalled 311.  [I am not sure if this includes pediatric deaths.]  Yet CDC claims that between 3,000 and 49,000 people die from flu in the US yearly.  Where does this number come from?  Good question.  The crystal ball is in an undisclosed location.  CDC has developed mathematical models that yield projected deaths.  But the models are never compared with real numbers (deaths associated with positive flu lab tests, for example) to see how accurate they are.

"Who Should Get Vaccinated?" asked CDC:

On February 24, 2010 vaccine experts voted that everyone 6 months and older should get a flu vaccine each year starting with the 2010-2011 influenza season. While everyone should get a flu vaccine each flu season, it’s especially important that certain people get vaccinated either because they are at high risk of having serious flu-related complications or because they live with or care for people at high risk for developing flu-related complications.

How many people actually received flu vaccine in the US last season?  I have had a hard time finding out the number.  More than one hundred nineteen million (119,000,000) doses of flu vaccine were distributed by CDC last year, and up to 165 million doses were made.

During the swine flu pandemic in 2009-10, I estimated (due to lack of reliable data) that between 60 and 80 million Americans received vaccine, or between 20 and 25% of the population.  It seems fewer Americans have been vaccinated since, based on media reports.  

I can't tell you how many Americans were vaccinated last season.  I cannot calculate a number needed to treat to prevent one death, but it could be one million or more.  Four hundred thirteen (413) flu deaths (pedi plus total, which may be an over count) have been documented.  We don't know the completeness of the reporting.  We don't know how many of those who died were vaccinated.  We don't know what the number of people is who have had adverse reactions to the shots, nor do we have information on the types and rates of adverse reactions.  We don't know the cost of the vaccination program, but it probably costs at least a billion dollars to cover vaccine manufacture, shipping, syringes, administration, and disposal of both syringes and mercury-containing excess vaccine, which must be treated as hazardous waste.

By the way, telephone surveys are the method used by CDC and RAND to determine how many people got vaccinated.  But flu survey responses are not accurate.  For example, 39% of adults reported getting vaccinated to RAND, but less than 25% nationally actually did.  In a survey of 400 doctors, conducted by the National Foundation for Infectious Disease, 90% reported getting vaccinated.  But other data reveal that under 50% actually do.


This year, CDC says an estimated 42.3% of Americans over 6 months were vaccinated, or about 130 million Americans.  Do you think about twice as many Americans were vaccinated for flu last year, during a mild flu season, as were vaccinated in 2009-10 for swine flu, when vaccine was hyped daily?  I think not.


It would be nice for our taxpayer-funded public health system to give American citizens (not to mention health care providers) accurate numbers so we could make an educated decision about the risks, benefits and costs of the recommended yearly flu vaccination.  But then we could perform an independent cost-benefit assessment of flu vaccine policy.  And (considering Cochrane found no clear benefit) it may turn out that this expensive program has little in the way of data to recommend it.  After all, if the benefits were demonstrable, why wouldn't the CDC tell us?

Strengthen Restrictions On Health-Threatening Chemicals, Says Study

From the journal Health Affairs, the entire May issue focuses on the health effects of exposures to toxic chemicals in the environment.  From the Health Affairs blog:

With growing evidence of the link between exposure to toxic chemicals and chronic diseases, especially in children, the United States needs to step up its efforts to protect the public from hazardous chemicals, say researchers writing in the May issue of Health Affairs. The Environmental Protection Agency (EPA), stymied by the outdated Toxic Substances Control Act (TSCA), must seek partners in academia to help evaluate the risks of industrial chemicals on the market today, write Sarah Vogel of the Johnson Family Foundation and Jody Roberts of the Center for Contemporary History and Policy at the Chemical Heritage Foundation.

The May issue of Health Affairs is the journal’s first-ever thematic volume on environmental health. You can listen to a Washington D.C. briefing featuring many of the authors from the issue (video available soon). An earlier blog post discussed four of the other articles that focus on the impact of environmental factors on children’s health. The issue and briefing were supported by a grant from the Kresge Foundation.

Some 83,000 chemicals are on the market, and under TSCA, enacted in 1976, companies do not have to prove their chemicals are safe. Instead, the federal government must prove whether a chemical is dangerous. This provision keeps potentially harmful chemicals on the market, increasing the risk to human health. Furthermore, the process required by the law to identify and control hazardous chemicals requires an extensive process of collecting, analyzing and evaluating data. This process consumes considerable government time and resources and acts as a roadblock to efforts to manage chemical risks and protect the public’s health, according to the Vogel and Roberts.

Since the Toxic Substances Control Act was enacted, we’ve learned a great deal about everyday chemical exposure and its contribution to a growing number of chronic diseases such as reproductive disorders, learning and behavioral disabilities, and diabetes, the authors observe. Yet the EPA has had a nearly impossible time regulating the use of hazardous chemicals, such as asbestos, because it is hindered by the very high burden of proof that falls on the agency.

With reforms to the Toxic Substances Control Act uncertain, given the current political and budgetary climate, the EPA must look beyond Washington to strengthen its oversight of chemicals and accelerate efforts to reduce exposures to those chemicals that might contribute to poor health, Vogel and Roberts write. They propose that the EPA partner with academic institutions and professional societies to test and evaluate the risks of high-priority chemicals — including those that are produced in the greatest quantities, are commonly found in the human body, and that pose a potential risk to children’s health and development.

These partners could generate independent analyses by using clearly defined and transparent evaluative standards and controlling for conflicts of interest, the authors say. Building such partnerships would also strengthen the EPA’s existing programs and better position it for any transitions that may come with changes to the Toxic Substances Control Act. In April, a bill was introduced in the US Senate that would reform the country’s chemical policy and align the United States more closely with changes in Europe. The bill would require chemical producers to submit safety data for all chemicals, new and existing, and prioritize substances of concern for review and risk management. Many states have already taken steps to limit the market for hazardous chemicals, such as restricting lead in toys and bisphenol A (BPA) in baby bottles.

Did Vaccines Cause Autism? The US Government has paid for 83 children who became autistic after vaccination

Today a press conference was held to announce publication of a study of Vaccine Injury Compensation Program decisions-- 83 were made in favor of children who developed autism after vaccination.  The peer-reviewed study by Mary Holland, Research Scholar and Director of the Graduate Legal Skills Program, NYU School of Law; Louis Conte, Robert Krakow, and Lisa Colin, was published in the Pace Environmental Law Review . 

However, the DHHS has claimed, "HHS has never concluded in any case that autism was caused by vaccination.” Really?

In an article by Vera Sharav of the Alliance for Human Research Protection, Sharav notes: 

The catalyst for this Pace law review of VICP published compensated cases, was the case of Hannah Poling.  In a 2008 report submitted to the VICP (which was leaked to the press) the Health and Human Services administration "conceded"  that vaccines had triggered Hannah Poling’s encephalopathy and subsequent developmental regression. HHS’s description of the child’s condition implied a distinction between “autism-­like symptoms” and “autism,” although there was no ambiguity that Hannah Poling in fact had autism.

In 2010, the VICP court award Poling $1.5 million, while denying other similarly injured children compensation. Nevertheless, in March 3, 2011, HHS baldly disclaimed its own 2008 "concession" document, stating in its Statistics Report: “HHS has never concluded in any case that autism was caused by vaccination.”

WHAT WILL IT TAKE FOR GOVERNMENT TO ACKNOWLEDGE A LINK BETWEEN VACCINES AND AUTISM?

Of note, a key similarity among the 83 successful claims, including the Poling case, claims which produced more than $96.7 million in settlements and awards, is semantics not evidence of injuries: the families who were successful in their claims did not assert that autism was their child’s primary injury.

White powder letters spook Washington as anthrax attack recalled/ Int'l Business Times

Curious timing of anthrax letters arriving at DC schools.  Might they have been sent in support of the child vaccine trial?  From IBT:

Nearly 30 schools in Washington DC have received envelopes containing a mysterious white powder and with ‘AL AQEDA-FBI’ written on them, the Federal Bureau of Investigation said on Thursday. Preliminary testing has proved that the powder was not harmful, the FBI has said.

Let's Test Anthrax Vaccine in Children/ Bio Prep Watch

Yesterday it was announced that the government would be purchasing 3.42 million doses of anthrax vaccine to add to the civilian anthrax vaccine stockpile.  This is on top of the military stockpile, and comes out of DHHS funds.  The purchase adds up to $101 million to the total contract for DHHS' anthrax stockpile, now worth about $500 million.  Stockpile cost could climb to over $2 billion if the government purchases the 75 million doses it said it needed. 

Emergent Biosolutions, the vaccine's manufacturer, also secured a $186.6 million contract for a recombinant protein antigen to combat anthrax and a $28.7 million contract for a third-generation vaccine.  Not too shabby for a 12 year old company purchased for about $20 million from the state of Michigan, selling one product, a vaccine developed by the US Army. According to the Wall Street Journal, between 2000 and 2010 Emergent received government contracts valued at about $1.4 billion.  Emergent's Board (2007 and 2011) is made up of national political operatives with little anthrax experience but impressive connections.

Vaccine vials expire after 3-4 years, requiring continuous replenishment.  What a marvelous business model!  And what a way to throw taxpayer money into a black hole, according to the Center for American Progress.

But the gaping yaw of Emergent Biosolutions wasn't satisfied.   Emergent's courtiers in Washington decided only one thing would appease it:  the sacrifice of virgins on the anthrax vaccine altar.

Children would have to become test subjects to "prove" the vaccine's "safety".  Later, children everywhere would be able to receive anthrax vaccine, were the government to declare an anthrax emergency. At present, the vaccine has never been tested in children, and it is not FDA-approved for their use.

Yet this vaccine is neither safe nor effective.   After the anthrax attacks, CNN reported that Bill Frist, M.D., bioterrorism expert and Senate Majority Leader pointed out:

"The vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that.  I do not recommend widespread inoculation for people with the vaccine in the Hart Building.  There are too many side effects and if there is limited chance of exposure the side effects would far outweigh any potential advantage."

According to a 2007 report by the Congressional watchdog agency, the Government Accountability Office (GAO):

"Officials from the VHC [DoD's Vaccine Healthcare Centers] Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death."

Yet these facts are being ignored, according to BioPrepWatch:

"Nicole Lurie, the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, last week asked the National Biodefense Science Board to investigate the safety concerns of collecting data on the effects of anthrax vaccine in children.

 Dr. Nicole Lurie

There is currently no safety, immunogenicity or efficacy data in pediatric and special populations that would allow the U.S. Food and Drug Administration to evaluate the drug for its utilization under an Emergency Use Authorization.  In the case of an emergency, adults could receive the countermeasures under the less stringent EUA status, while an investigational protocol would still need to be developed for its use in children and special populations. This would present an array of logistical, clinical and communication challenges during a public health crisis." (emphasis added)

There are several ways to read this.  The first is, YES: giving anthrax vaccine to children would present an array of challenges, since an anthrax vaccine trial fails to meet the normal legal standard with respect to clinical trials in children.  These must entail no more than minimal risk if a child does not have a condition that would benefit from the intervention being studied (45 CFR 46, subpart D).  There is one rarely used exception for "not otherwise approvable" research in children, and it requires assent of an advisory panel, "sound ethical principles" and consent of both children and parents.  DHHS will probably try to squeeze the proposed research through under this exception, 45 CFR 46.407.

Another way to interpret these challenges is that the federal government cannot justify using the vaccine in children, let alone adults, in an emergency, given the following facts.   But then how would it explain the large vaccine stockpile?  On the other hand, if DHHS could generate scientific evidence to support vaccine use, it might circumvent those challenges:

a)   LOGISTICAL:  The vaccine takes 5+ weeks and 2 doses before it provides significant immunity.

b)   CLINICAL:  Antibiotics (and monoclonal antibodies) are effective immediately, so there is probably no meaningful role for a vaccine whose benefit only starts 5-6 weeks after exposure.

• Remember, antibiotics were 100% effective at preventing anthrax after the letters attack, while at best, this vaccine is no more than 90% effective, and may be much less effective.  
• Remember, we are talking about preventing and treating a fatal disease.  No matter what the government says, doctors cannot in good conscience switch from a highly effective drug treatment to a less effective vaccine, sacrificing some patients to a theory of vaccine benefit.  
• Be aware there exist no human efficacy data to support the use of the current anthrax vaccine after exposure to inhaled anthrax.

c)   COMMUNICATION:  Government spokespersons would look like morons trying to justify use of the vaccine in children, when the media present both sides of the story... as they already have.  In 2001, 32,000 people who were possibly exposed to anthrax took antibiotics and were offered additional vaccine; only 198 (less than 1%) accepted anthrax vaccinations, the rest having watched the news.

• The vaccine has caused thousands of serious illnesses in soldiers.
• Vaccine effectiveness in animals varies widely, depending on the strain of anthrax used and the amount of spores inhaled.
• In humans, antibody levels vary widely depending on HLA type.  So depending on your genes, you may not develop immunity even after multiple vaccinations.
• According to the Washington Post, Army tests in vaccinated monkeys revealed many got sick from anthrax despite vaccination, though most survived.

Current law does allow FDA to issue an Emergency Use Authorization (EUA) for drugs that have not been tested for safety in humans, during emergencies. (So the proposed child research is not, strictly speaking, necessary.)

FDA issued an EUA in 2005 for use of anthrax vaccine in military servicemembers.  The EUA  allowed the military to continue to use the vaccine, after a federal judge revoked its license due to lack of proof of efficacy.  FDA knows about the vaccine's dangers; it has collected thousands of reports of illnesses related to anthrax vaccine.  Perhaps FDA did not want to sign off on an Emergency Use Authorization (EUA) for children, given the known facts about the vaccine.

Or perhaps DHHS decided the Department would be in a stronger legal position if  evidence of anthrax vaccine "safety" in children were generated before widespread use.  This is because DHHS, not the manufacturer, is on the hook for damages if the vaccine causes injuries, as a result of the 2005 Public Readiness and Emergency Preparedness Act.

Did Nicole Lurie, M.D. want an honest, independent review of anthrax vaccine research in children?  If so, she took her concerns to the wrong place.  Who are the members of the National Biodefense Science Board, an entity created by Dr. Lurie, in part, to provide support for controversial decisions?

One member is retired Colonel John Grabenstein, Ph.D., who led the military anthrax vaccine program from 1999 through 2006, supervised multiple poorly conducted studies of anthrax vaccine safety, then moved to Merck Vaccine as a VP.  (I have critiqued the research projects here, here, here and elsewhere.  FDA noted serious methodological issues with the studies in its 2002 package insert.)

A second member is retired Major General John Parker, M.D., a former Commander at Fort Detrick, where anthrax vaccine was developed and has been researched for over 60 years.  He has been a strong anthrax vaccine proponent, and is currently a vice president of SAIC, which happens to be in the military vaccines business.  No one else in Lurie's advisory group is an anthrax vaccine expert.  Since only the military has used the vaccine, the other members will likely defer to the two experts on the panel, whose reputations rely on the vaccine being safe and effective.

The panel will issue its recommendation in the fall.  Whose children will then be used in the name of Biodefense Preparedness?  Will they belong to Emergent's officers or Board?  To DHHS officials?  To retired military officers?  Or will they be recruited from an inner city medical center with a high minority population?  What exactly will the consent form disclose about the vaccine's risks?

UPDATE:   Eight years ago, a similar trial of smallpox vaccine in children was proposed.  Professors Paul Offit and Robert M. Nelson of the University of Pennsylvania wrote a detailed analysis of why the proposed trial would not be conducted ethically (or legally) under federal regulations that still guide the conduct of human subject research. 

It was pointed out by Professor William Bicknell of Boston University that "THE CONSENT FORM (of the smallpox trial) NEVER STATES THE CHILD IS AT RISK OF DEATH OR SERIOUS DISABILITY FOR WHICH THERE IS NO KNOWN TREATMENT."  Presumably the same would be true of the consent form for anthrax vaccine, as there is no known way to reverse anthrax vaccine-related illnesses, and were the 1-2% risk of potential disability or death to be disclosed, there would be no willing subjects.

UPDATE:  Here is the letter Dr. Lurie sent to her National Defense Science Board asking for their help in getting the pediatric anthrax vaccine trial going (despite the fact it violates federal regulations, which she failed to mention).

UPDATE:  According to the May 26, 2011 Wall Street Journal:

"Emergent BioSolutions Inc.'s (EBS, $25.33, +$3.89, +18.14%) shares hit their highest point since 2009, as the company is expected to receive a five-year contract potentially worth more than $1 billion from the U.S. government for its anthrax vaccine BioThrax. The U.S. government surprised observers by sending a request for proposal seeking more anthrax vaccine. Because Emergent is the only registered Anthrax vaccine maker, it's essentially guaranteed the contract, Wedbush said. The firm, which values the pact at more than $1 billion based on the vaccine's price, said "five-year visibility into sales is exceptional in any business." Emergent said any contract will likely be finalized during the third quarter."

Apparently the contract is a done deal, as Bioport's rep in Congress, Mike Rogers (who authored the legislation creating BARDA in 2006) praised the decision to award Emergent the contract.http://bioprepwatch.com/news/248321-rep-mike-rogers-praises-biothrax-contract

Vaccine Ingredients: a list

There was a lot of interest in my discussion of the benefit of knowing the ingredients in vaccines.  There was further interest in what these ingredients are.  I have therefore annotated a CDC-derived ingredient list for vaccines by highlighting those ingredients derived from animals or humans, and circling in red those ingredients obtained from a human fetal cell line, MRC-5, derived from lung fibroblasts.  Click HERE for the annotated list.

UPDATE:  And here is a second list of vaccines containing human cell ingredients, provided by the National Vaccine Information Center, that appears more complete than the list I posted earlier and the information comes directly from the package inserts:

Which vaccines contain human protein and DNA?

The information in this table is drawn from vaccine package inserts downloaded from the FDA website.  The Vaccine Ingredients Calculator, following the lead of the package inserts, treats each source of human protein and DNA as a distinct ingredient.

A recent CBS News Investigates article quotes a former senior scientist at a pharmaceutical firm who claims that human tissue is currently used in 23 vaccines; however, we adhere strictly to the vaccine package inserts from the FDA as our ingredient data source and cannot confirm nor deny this claim.

How the US Detoured to Massive Debt/ WaPo

Appreciate the Washington Post giving us real numbers to improve our grasp of the deficit as we grapple with how to lower it (and in the near term, simply lower its growth rate).

The nation’s unnerving descent into debt began a decade ago with a choice, not a crisis.
In January 2001, with the budget balanced and clear sailing ahead, the Congressional Budget Office forecast ever-larger annual surpluses indefinitely. The outlook was so rosy, the CBO said, that Washington would have enough money by the end of the decade to pay off everything it owed.

Voices of caution were swept aside in the rush to take advantage of the apparent bounty. Political leaders chose to cut taxes, jack up spending and, for the first time in U.S. history, wage two wars solely with borrowed funds. “In the end, the floodgates opened,” said former senator Pete Domenici (R-N.M.), who chaired the Senate Budget Committee when the first tax-cut bill hit Capitol Hill in early 2001.
Now, instead of tending a nest egg of more than $2 trillion, the federal government expects to owe more than $10 trillion to outside investors by the end of this year. The national debt is larger, as a percentage of the economy, than at any time in U.S. history except for the period shortly after World War II...

The biggest culprit, by far, has been an erosion of tax revenue triggered largely by two recessions and multiple rounds of tax cuts. Together, the economy and the tax bills enacted under former president George W. Bush, and to a lesser extent by President Obama, wiped out $6.3 trillion in anticipated revenue. That’s nearly half of the $12.7 trillion swing from projected surpluses to real debt. Federal tax collections now stand at their lowest level as a percentage of the economy in 60 years.
Big-ticket spending initiated by the Bush administration accounts for 12 percent of the shift. The IraqAfghanistan wars have added $1.3 trillion in new borrowing. A new prescription drug benefit for Medicare recipients contributed another $272 billion...

SOURCES: Pew Fiscal Analysis Initiative analysis of CBO data. By Alicia Parlapiano/The Washington Post. Published on April 30, 2011, 7:00 p.m.

Doubt of anthrax suspect's role resurfaces in lawsuit/ Palm Beach Post

Bob Stevens' family's attorney has filed papers disputing the role of Bruce Ivins (in a much delayed lawsuit against the federal government), regarding the wrongful death of Bob Stevens, a photo editor at the National Enquirer who died after exposure to an anthrax letter in 2001.  From the Palm Beach Post:

Maureen Stevens' attorneys originally agreed to accept the findings of the estimated $100 million FBI investigation. But when Ivins' bosses at the military lab in Maryland insisted under oath that he lacked the time, equipment and know-how to produce the anthrax, the attorneys said they could no longer accept the findings.

They asked for permission to dispute Ivins' role in Stevens' death when the $50 million lawsuit against the federal government goes to trial in December or January. U.S. District Judge Daniel Hurley, who will decide the case, approved their request. That doesn't mean Ivins won't loom large during the trial...

[Two former supervisors of Ivins, also] bacteriologists testified that a variety of people used the lab. "We had people from Egypt, Poland, India, Iran, Latvia and China," Byrne [one supervisor] said...

Still, Schuler said, Maureen Stevens' case against the government doesn't turn on Ivins' guilt or innocence. At its core, the case is relatively simple, he said: The government was negligent in Bob Stevens' death because it didn't provide sufficient security at the labs where anthrax was kept. In court papers, the government concedes that before the attacks, Fort Detrick didn't have cameras to monitor the labs and didn't search workers for pathogens when they were leaving the base.

"We just have to show that there was bad security," Schuler said. "We don't have to solve the crime..."

Drug watchdog halts injections after adverse reaction in patients/ Australian

From the Australian:

THE drug regulator has told GPs to stop giving patients a second dose of a vaccine that protects against pneumococcal disease, after more than 80 Australians suffered severe reactions, including severe swelling and abcesses.
The Therapeutic Goods Administration said it was investigating what could have caused 178 reports of reactions to the Pneumovax 23 vaccine, which is meant to protect against a potentially life-threatening bacterial infection that can cause meningitis and death and is mainly given to adults.
Of the 178 reaction reports made from January 1 to April 14, 169 related to reactions at the injection site, of which 82 were deemed severe, and included the skin inflammation cellulitis, swelling from the shoulder to the elbow and abcesses.
In a statement, the TGA said that although such reactions were specifically mentioned as possible side-effects in the information provided with the vaccine, the sheer number had triggered the agency's concern...

The latest scare follows an earlier incident with the same vaccine in March, when the TGA ordered a recall of one specific batch after a cluster of seven patients reported similar reactions.

‘Veterans court’ faces a backlog that continues to grow/WaPo

Half of combat veterans from Afghanistan and Iraq have filed for benefits since 2001.  From the Washington Post:

The caseload at the U.S. Court of Appeals for Veterans Claims has doubled in recent years, with the court deciding more than 600 cases per judge each year — far more than other federal appellate courts.... By the time Bruce E. Kasold became chief judge in August, hundreds of cases were awaiting decisions. Retired judges had been helping with motions and simpler cases, but Kasold decided to turn more complex cases over to the retirees, who work with the help of staff attorneys.

... Congress created the court in 1988, after lobbying by Vietnam veterans. Before that, veterans who were denied benefits had no judicial recourse.

... New claims at the VA have nearly doubled since 2005, and of the 1.3 million living combat veterans discharged since 2001, nearly half have filed for benefits.

Flu Warning: Beware the Drug Companies!/ NY Review of Books

This long piece meanders from the H1N1 pandemic and the billions spent to save us from a flu much less malign than usual, to the marketing of Tamiflu (a dangerous drug for influenza whose efficacy may be zero) to the problems with industry control of research on all drugs in our pharmacopeiea.  The points may be familiar to readers of this blog.  But the issues are crucial to resolve if we are to regain trust in our medications and our medical litreature.  By Helen Epstein:

... On June 11, 2009, Margaret Chan, the director-general of the WHO, announced that a “pandemic emergency”—or worldwide epidemic—of H1N1 influenza was officially underway. Governments around the world placed immediate orders for anti-flu drugs and vaccines worth hundreds of millions of dollars, as a new stock index, *RXFLU, tracked company profits. According to J.P. Morgan, up to $10 billion was spent globally on “influenza preparedness” in 2009, including over $4 billion by the US alone.⁶

The predicted dire emergency did not occur. In the 2009–2010 “influenza season” about 18,000 people died from the disease worldwide, fewer than in previous years, and the vast majority of victims had serious underlying conditions such as cancer, lung disease, AIDS, or severe obesity, which can impair breathing.⁷ Since one influenza strain usually dominates all others during a typical flu season, H1N1 may actually have saved lives by displacing more aggressive viruses. The WHO maintains that its decisions were based on the best available evidence, but last year European governments, stuck with hundreds of millions of euros’ worth of unused medicines and vaccines, began asking questions.
In March 2010, a Council of Europe report⁸ concluded that the H1N1 virus was known to be mild well before the WHO issued the pandemic “declaration” and expressed concern about the influence of powerful pharmaceutical companies over decision-making at the agency. A draft of the WHO’s response was released in March 2011.⁹ It calls for more “transparency” but concludes that “no critic of WHO has produced any direct evidence of commercial influence on decision-making.” Unfortunately, the response does not account for the billions of dollars lost in the panic or for the lives that may have been put at risk by the agency’s hasty medical recommendations...

GlaxoSmithKline’s diabetes drug Avandia was linked to thousands of heart attacks, and earlier in the decade, the company’s antidepressant Paxil was discovered to exacerbate the risk of suicide in young people. Merck’s painkiller Vioxx was also linked to thousands of heart disease deaths. In each case, the scientific literature gave little hint of these dangers. The companies have agreed to pay settlements in class action lawsuits amounting to far less than the profits the drugs earned on the market.⁵⁴ These precedents could be creating incentives for reduced vigilance concerning the side effects of prescription drugs in general....
Forcing drug companies to make all their original data available to all independent researchers would achieve much the same thing, and cost absolutely nothing. Legislators and the public should demand both of these reforms without delay.

Was FBI too quick to judge anthrax suspect killer?/ McClatchy

Greg Gordon may not be as well-known as some investigative journalists, but he is one of the best in the business.  Greg has penned an incredible series on Goldman Sachs, detailing how the company bet against investment vehicles they had designed (to fail), for which he was a finalist for a Pulitzer last year.  [See the sidebar for links to his many 2009 stories on the financial crash.]  He has continued to cover this area, as well as many others, turning out a major story a week.

Today Greg Gordon focused on the evidence against Bruce Ivins, pointing up a major failure in the FBI's case.  This failure is the FBI's inability to link a contaminant found in the first set of letters to Ivins.  It is not clear how hard the FBI tried to find the contaminant in anyone else's laboratory.

The contaminant is Bacillus subtilis, a usually benign bacterial strain that is closely related to the bacteria that cause anthrax.  Whoever made the anthrax for the first set of letters included some Bacillus subtilis in the mix, and therefore had it in their possession (and lab).  The FBI's failure to find this contaminant in hundreds of samples from Ivins' home, car, office and laboratory virtually assures us that Ivins did not grow the anthrax for the first set of letters... at least not in the only lab equipment to which he had access.

UPDATE:  Video of Greg Gordon discussing this subject is here.

...  But the FBI's decision not to fully test for the distinct bacterial contaminant, pieced together by McClatchy Newspapers in interviews with scientists, federal law enforcement officials and in a review of recently declassified bureau records, could reignite the debate over whether its agents found the real killer.

The Justice Department closed the eight-year investigation, said to cost as much as $100 million. However, none of the circumstantial evidence it found showed that Ivins prepared the deadly powder, scrawled "Death to America" in a seeming mimic of al-Qaida, or twice sneaked away on 61/2-hour roundtrip drives to drop them in a Princeton, N.J., mailbox.

If the FBI got the right man, then there is no consequence to its decision to stop hunting for bacillus subtilis, a harmless bacterial contaminant that resembles anthrax. But if Ivins was innocent, then the killer is at large, and the bureau may have missed a big opportunity...

One person close to the investigation, who requested anonymity to avoid harming relationships, suggested that FBI officials felt "trapped" by Ivins' suicide.  "If they ever had any doubts, once he committed suicide, they had to unite," this person said. "Otherwise, you've driven an innocent man to suicide. And that's a terrible thing..."

Read more: http://www.miamiherald.com/2011/04/20/2177735/was-fbi-too-quick-to-judge-anthrax.html#ixzz1K7VyFsLk

EU agency flags narcolepsy risk on GSK flu shot/ Reuters

From Reuters today:

European regulators have recommended changes to the product label for GlaxoSmithKline's (GSK.L) pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.  The decision is based on preliminary results of studies from Finland, Sweden and France suggesting a possible link between the vaccine and the rare sleeping disorder. The move does not apply to adults...

UPDATE:  Press Release from the European Medicines Agency.

Why vaccines for emergencies should not be mandated/ Nass testimony

UPDATE:  Both LD 941 and LD 694 made it out of committee and will be voted on by the entire legislature.--Meryl

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609

April 9, 2011

Dear HHS Committee Member (Maine Legislature):

I am writing with regard to LD 941 and the subject of mandatory vaccinations. I am an internist

who has practiced in Maine since 1997.  I am knowledgeable about medical emergencies

designated by the governor, or by the Secretary of DHHS, and about vaccine safety.  I have

testified to the US Congress on bioterrorism and emergency vaccinations 7 times (3 oral, 4

written). I treat vaccine-injured patients. I have also submitted testimony for LD 694.

Governor Baldacci declared an emergency during the 2009 swine flu pandemic. We now

know that swine flu caused fewer deaths than ordinary seasonal flu epidemics.[1] The swine flu

pandemic caused little disruption in Maine, but an emergency declaration was made nonetheless.

It could have, but did not, lead to mandatory vaccinations in Maine. We now know swine flu

vaccinations were unnecessary for all but high-risk patients.

Vaccines are an important component of public health. But they should not be seen as a panacea

in times of emergencies and disasters.

Vaccines are drugs, and like drugs, their benefits and risks cannot be wholly understood until

they have been given to large numbers of people. The numbers required, and the duration of

time that must elapse, preclude adequate data coming from clinical trials.[2] In other words, until

millions of people have received a vaccine, we do not know what its risks are.

The recent swine flu pandemic is instructive. New vaccines were hurriedly developed [3] and

given to hundreds of millions of people worldwide. Over a year later, we have learned that

the CSL vaccine used in Australia caused one seizure for every 100-200 children vaccinated,

approximately ten times the expected rate of this adverse reaction. In Finland, the GSK Pandemrix

swine flu vaccine led to 20 times the expected rate of narcolepsy in children. Twelve other

countries are investigating narcolepsy increases.

In the US and worldwide, pandemic vaccine manufacturers (and those involved in planning and

administering vaccinations) were given a waiver of liability for adverse reactions caused by these

vaccines. [4] Injured recipients have no ability to sue for damages, and await (possible) payments from the federal government. [5]

Swine flu vaccinations in 2009 were voluntary. However, since the pandemic appeared, swine

flu and/or seasonal flu vaccinations became required (outside Maine) for many hospital and

clinic employees, by their employers and by NY State. Vaccinations were ordered by NY’s

appointed public health chief. An injunction was then issued against mandatory vaccinations [6]

and NY’s Governor Patterson reversed the vaccine mandate.

Surprisingly, no published data exist to show that vaccinating staff at health care facilities protects patients, either by reducing hospitalizations or by reducing deaths due to flu.

Smallpox vaccine caused so many serious side effects that the 2003 plan to vaccinate millions

of Americans stopped after only 40,000 civilian vaccinations. A National Academy of Science

panel found little evidence to support the program’s benefit. [7] Anthrax vaccinations have caused

serious chronic illnesses in 1-2% of military personnel vaccinated, according to the Government

Accountability Office (GAO). [8] A little-known fact is that FDA can issue (and has issued)

Emergency Use Authorizations, [9] allowing unlicensed drugs and vaccines (that may not have

undergone human testing) to be used.

To sum up:

1. When an emergency strikes, the need to “Do Something” is very strong, and emergency

vaccinations may be a solution chosen by government officials.

2. Emergencies can be declared in Maine with very little basis, yet may result in forced

vaccinations.

3. Vaccines developed for emergencies are more likely than standard vaccines to have

safety problems, due to rapid development, insufficient testing and the liability waiver

given to their manufacturers.

4. Because vaccines for emergencies are given to large numbers of people in a short period

of time, their serious side effects probably won’t be known until after millions have been

vaccinated.

5. Vaccines likely to be mandated will be those with unknown safety problems and

uncertain effectiveness, or those that are already known to be dangerous.

6. Vaccine mandates are increasing. They are controversial and lead to legal actions.

7. Maine citizens should be protected from vaccine mandates issued by those who may

be unaware of their potential ramifications. Maine citizens deserve to choose what is

injected into their bodies. Please support this bill.

Sincerely yours,

Meryl Nass, M.D.

 1.  http://www.europarl.europa.eu/en/pressroom/content/20110308IPR15032/html/Swine-flu-learning-from-past-mistakes

 “H1N1 had caused 2,900 deaths in Europe by April 2010, which compares with 40,000 for seasonal flu in a moderate year.” [European Parliament]

 2.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html

 “Special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.” [WHO]

 3.  http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html

 “Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.” [WHO]

 4.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]

 5.  http://www.pandemicflu.gov/professional/federal/vaccineliability.html [US Government]

 “The U.S. Department of Health and Human Services is establishing a Countermeasures Injury Compensation Program for H1N1 vaccines. Under this program, compensation may be available to eligible individuals who suffer serious physical injuries or death from administration of the vaccine under the declarations. Eligibility, and the types of injuries for which compensation may be available, will be defined by regulations. Compensation can include medical benefits, lost wages and death benefits.”

 6.  http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/?partner=rss&emc=rss [NY Times]

 7.  http://www.nap.edu/catalog.php?record_id=11240#toc [National Academy of Sciences]

 8.  http://www.gao.gov/new.items/d07787r.pdf [GAO]

 9.  http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm#categories [FDA]

Why vaccines should be given with a list of their ingredients/ Nass testimony

UPDATE:  Here is a list of vaccine ingredients posted by CDC.  I have annotated the list with yellow highlights for animal-derived materials, and annotated in red MRC-5 DNA and protein.  MRC-5 is a human fetal cell line derived from lung tissue. -- Meryl


Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609

April 9, 2011

Dear HHS Committee Member:

Re:  LD 694, bill requiring that a list of vaccine ingredients be provided with all pediatric vaccinations

1.  Listing vaccine ingredients may not be absolutely necessary.  But consider that FDA requires food manufacturers to list all ingredients.  This allows consumers to avoid ingredients to which they may be allergic, and avoid those to which there may be a religious prohibition.

Some vaccines contain eggs, which occasionally cause serious allergic reactions.  Some vaccines contain gelatin (prohibited for kosher Jews); others are made in [aborted] fetal cells or their derivatives, and are avoided for that reason.

2.  Hundreds of new vaccines are in development, and they contain a wide array of new ingredients to stimulate increased immunity.  These ingredients do not have to be tested for their individual toxicity:  their only required testing occurs during a clinical trial of the complete vaccine.  Most human vaccine studies last one month.  If no serious side effect is identified within that period, the tested vaccine may be licensed.

This kind of testing is insufficient to identify whether the vaccine or its components may cause or promote cancers.  It will miss most birth defects and autoimmune illnesses that might be related to vaccination.  Vaccine trials usually avoid pregnant women.  Cancers and autoimmune illnesses may take months or years to appear.

3.  In 2009-10, swine flu vaccines were made with and without novel adjuvants (new additives used to enhance the immune response), using abbreviated testing.  Novel adjuvants had not been used in previously licensed US vaccines.

Recently it was learned that the Pandemrix swine flu vaccine caused or contributed to narcolepsy in children, and that some other swine flu vaccines caused seizures.  Their use in children has been stopped in some countries (Finland [1], Ireland [2] and Australia [3],  for example).

Pandemrix, made by GlaxoSmithKline, used a novel adjuvant that had not been used in children before, nor used in the US.  Subsequently, Glaxo’s Cervarix HPV vaccine was licensed in the US, containing this novel adjuvant.

This offers an example of how an ingredient list would be beneficial:

The Pandemrix adjuvant is not present in Merck’s Gardasil HPV vaccine, but is present in Glaxo's Cervarix HPV vaccine.  Knowing the ingredients, one could make an educated choice about which vaccine to use.

4.  Consider the difference between ingesting food and injecting vaccines.  Food has to pass through the gastrointestinal tract, which acts as a barrier against noxious substances entering the body, protecting us from harm.

Injections bypass all skin and mucosal barriers, overriding important protective mechanisms.  Substances injected into us therefore need even more careful vetting than is given to foods. Vaccines should be at least as safe as foods, and their components should be equally transparent.

5. Providing a list of ingredients at the time of inoculation will not add a significant burden to medical providers or manufacturers.

Federal regulations already require that a CDC-designed “Vaccine Information Statement” be given to parents with each child’s inoculation.  This form could be easily amended to include a list of vaccine ingredients. 

An ingredient list is part of the vaccine label/package insert that is included with every bottle of vaccine sent to vaccine providers. This package insert or its list of vaccine ingredients could be given to patients with the Vaccine Information Statement.

Thank you for the opportunity to comment on this piece of legislation.

Sincerely,

Meryl Nass, M.D.

1.   http://www.yle.fi/uutiset/news/2011/01/health_official_swine_flu_vaccinations_for_children_possibly_a_mistake_2326931.html
2.   http://www.independent.ie/health/swine-flu/gps-must-return-flu-vaccine-over-narcolepsy-fears-2607513.html
3.  http://www.theaustralian.com.au/news/health-science/risk-of-fits-prompts-bans-of-four-flu-jabs/story-e6frg8y6-1226020122589

GPs must return flu vaccine over narcolepsy fears/ Independent

In early January, Ireland's Health Service Executive advised doctors to use the Pandemrix (GSK) brand of swine flu vaccine only in the event they ran out of seasonal flu vaccine.  This is the brand linked to narcolepsy cases.

Apparently that warning was not sufficient.  On April 3 Ireland's Health Service informed doctors that they would be coming to the offices of all GPs to remove any remaining Pandemrix vaccine stock:

The Heath Service Executive (HSE) will remove all stocks of the swine flu vaccine Pandemrix from GPs' surgeries, the Sunday Independent has learned.
The vaccine has been linked to the disabling sleep disorder, narcolepsy...

Sweden's Medical Products Agency concluded that those under 20 vaccinated with Pandemrix may be four times as likely to develop narcolepsy than those who did not get the shot. 
The Swedish findings by the Lakemedelsverket agency broadly reflect a recent study in Finland, though that investigation found that the risk of children suffering from narcolepsy was nine times higher among those vaccinated with Pandemrix.
Since August 2010, at least 12 countries have reported cases of narcolepsy, particularly among young people...

GPs are told in the HSE directive that while there has been an increase in narcolepsy in Finland and Sweden, it has not been noted in all countries using Pandemrix.
"No increase has been seen in the United Kingdom, which also used Pandemrix," the briefing document noted.
The European Centre for Disease Control is undertaking a study in nine European countries, with the results expected by July this year.
"The European Medicines Agency has stated that no definitive conclusions can be drawn until further studies are completed and has therefore not recommended any changes to the marketing authorisation for Pandemrix," it said.
Here, the Health Protection Surveillance Centre will now work with the IMB to examine data available on narcolepsy in Ireland.
"In summary, there has been conflicting data emerging in relation to narcolepsy and the situation is as yet unclear," the HSE told Irish doctors.