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 The Environmental Protection Agency (EPA), stymied by the outdated Toxic Substances Control Act (TSCA), must seek partners in academia to help evaluate the risks of industrial chemicals on the market today, write Sarah Vogel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.

Rise in sleep illness cases linked to swine-flu jab/ Ireland Independent

Still no news about narcolepsy or any other specific adverse effects from the US and Canada, who used the most  swine flu vaccines in 2009 and 2010.  So much for claims that the US put into effect special monitoring programs for this vaccine!

Ireland is finding increased narcolepsy cases in the vaccinated 4-19 age group as well as Finland and Sweden.

... Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed that it had reviewed further information from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix.
"The committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy.
"Further analyses and study results are awaited to clarify the observations in Finland."
In addition to the information coming from Finland, research is continuing in Sweden, where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix.
In last month's statement, the CHMP said that other non-Nordic countries had not seen similar increased rates of reporting of narcolepsy.
That assessment may change in the light of the eight suspected cases that have been reported in Ireland of people who have received the Pandemrix vaccine and who have subsequently developed narcolepsy...

Anthrax Redux: Did the Feds Nab the Wrong Guy?/ Wired

Noah Schactman has an extremely detailed, useful piece on the anthrax mailings in Wired.  Noah did his homework.  The 72 comments are also interesting.

UPDATE:  Podcast with Noah here.  Extracts of the magazine story follow:

In February 2003, anthrax became part of the rationale for invading Iraq. Colin Powell went to the United Nations Security Council, in part to discuss the potential bioweapon. “Less than a teaspoonful of dry anthrax in an envelope shut down the United States Senate,” he said. “Saddam Hussein could have … enough to fill tens upon tens upon tens of thousands of teaspoons.” Two weeks later, Tom Ridge told Americans to buy duct tape and plastic sheeting to protect themselves from a bioterror attack. Four weeks after that, the invasion of Iraq began.

The National Research Council report also casts doubt on whether the killer spores really were descendants of Ivins’ RMR-1029 flask. The FBI resampled RMR-1029 a total of 30 different times, the report found. They could get all four telltale morphs on only 16 occasions.

Further, the FBI says that only eight samples in its Ames repository were genetic matches to all four morphs of the killer spores—and that the scientists with access to those isolates were thoroughly scrutinized. But the National Research Council found that the FBI’s collection can’t be fully trusted: Too many of the samples were intermingled or descended from other labs’ anthracis to provide a truly representative cross-section of Ames anthrax. This may also be a reason why nearly one in 10 samples in the repository tested positive for at least one mutant.

Paul Keim, who helped assemble the FBI’s Ames collection, still wonders how much to trust an anthrax repository that relied on scientists (and potential murder suspects) submitting their own samples. “We don’t know if people did it correctly, and there’s no real way to control for that,” Keim says...

There are still other problems with the case against Ivins. The killing spores were so volatile that they cross-contaminated piles and piles of mail. Yet spores were never found in Ivins’ house or his car, and only a handful were discovered in his lab. There’s no evidence of any trip to Princeton to mail the letters. And just because the killer spores were descendants of a USAMRIID flask, there’s no guarantee a USAMRIID scientist was actually the mailer. In fact, the FBI was never able to prove where the attack anthrax was cultured. “It would’ve been very easy to take the anthrax out, to steal some,” a former USAMRIID officer says. “Anybody could do that.”

Finally, there’s the matter of motive. The Justice Department asserts in its investigative summary that Ivins mailed the letters to gin up support for an anthrax vaccine, offering a few ambiguous emails and comments to friends and investigators as proof. If there’s any further, credible evidence to support this notion, Wired couldn’t find it in the thousands of pages of case documents released by the government or in the hours of interviews conducted with the investigators. Montooth [who led the FBI's case in the beginning] concedes it’s a placeholder rationale at best...

There’s an irony in the fact that the culprit was likely a top government anthrax expert: Since 2001, the US has built dozens of labs, spent just under $62 billion, and hired an army of researchers to prevent a second bioterror attack. In effect, Washington has devoted the past decade to training and equipping hundreds of people like Ivins.

It’s an unnerving scenario. But there’s something much scarier to contemplate. There’s still the possibility that the government was as wrong about Ivins as it was about Hatfill. If that’s the case, the anthrax mailer is still at large. And that means someone launched the deadliest biological attack in the history of the United States—and got away with it.

David Kelly inquest plea made to David Cameron/ BBC

From the BBC:

A group of doctors campaigning for a full inquest for Dr David Kelly have appealed to Prime Minister David Cameron to intervene on their behalf...

And, addressing the prime minister directly, they caution: "If an inquest is denied, despite all the evidence carefully provided to the attorney general, there is a real and grave risk that your government will be seen as continuing, and being complicit in, an enormous conspiracy to pervert the course of justice.  "Further, any 'no' decision will be vigorously contested in the courts via judicial review by the doctors' lawyers..."

Pushing the envelope: Psychobabble "solves" FBI's case/ NYT

A group of psychiatrists [UPDATE:  See Dr. Jeffrey Kaye's analysis of the panel composition] offered their forensic expertise in solving the anthrax criminal investigation, by using their insight into the criminal mind.  Somehow DC Judge Royce E. Lamberth blessed them, and FBI paid the $38,000  bill.  The group only had one suspect, whose confidential medical records were supplied by the FBI.  The Executive Summary makes clear that the panels' conclusions were built into its charge:

...the Panel was asked to offer, based on the available materials, a better understanding of Dr. Ivins’ mental state before and after the anthrax mailings, his possible motives — and the connections, if any, between his mental state and the commission of the crimes.

If the group's trove of documents resembled that of the National Academy of Sciences panel, then it was carefully cherry-picked, designed to elicit a single conclusion.  The NY Times' Scott Shane notes their conclusion:

“Dr. Ivins was psychologically disposed to undertake the mailings; his behavioral history demonstrated his potential for carrying them out; and he had the motivation and the means,” the panel wrote in its 285-page report, released at a news conference on Wednesday...  It also found that Dr. Ivins, who was 62 when he died, was “homicidal” in the last weeks of his life. Only his involuntary commitment for psychiatric treatment, the panel wrote, “prevented a mass shooting and fulfillment of his promise to go out in a ‘blaze of glory,’ “ the report said.

How much of their evidence is derived from Ivins' alcohol abuse counselor, who was under house arrest at the time and working with the FBI in the final months of Ivins' life?  Was her profound conflict of interest clear to these experts?

How could these experts possibly know Ivins had the motivation and means, when the FBI failed to produce a logical motive or provide evidence of means?

From the report's executive summary:

The key themes were revenge, a desperate need for personal validation, career reservation and professional redemption, and loss. These themes guided him not only in making the attacks, but in choosing his targets and shaping his methods...

The [mail]box thus appears to have represented to him the two key reservoirs of his obsession and rage. Dr. Ivins’ statements to therapists and the FBI suggest that KKG represented authority and all the successful, talented, attractive people who had rejected him and inspired his rage. Princeton represented his father and perhaps his unmet college aspirations and the humiliation and rage wrapped up in these concepts for him. For him, dropping anthrax in this [mail]box appears to have represented both a conquest and a desecration — in short, payback.

Is psychobabble too strong a word to describe this outpouring of gibberish?

UPDATE:  Scientia Press has an analysis of Ivins' criminal propensity/ lack of any history of aggression here.

This report was completed last August, but was pulled out of the deep freeze yesterday in a last-ditch attempt to trump the NAS report. The website that offers this report for sale, provides the Executive Summary and  bios of the authors ends with the following, in a clear attempt to link this psychiatric report to the NAS report, and presumably give it equal weight in future discussions of the case. 

National Academy of Sciences (NAS) Panel

Investigators in this case relied on new microbial forensic techniques developed by government, academic, and private-sector scientists to address these specific attacks. Because these techniques were new, the FBI requested the formation of a separate commission through the National Academy of Sciences to evaluate “the reliability of the principles and methods used by the FBI, and whether the principles and methods were applied appropriately to the facts.” At the time of this report’s submission to Chief Judge Lamberth in August 2010, that report had not yet been released.  The report was released on February 15, 2011.

2/3 of Whooping Cough Patients in California Fully Vaccinated/ KPBS and CDC

From San Diego's station KPBS:

SAN DIEGO — A KPBS investigation has found that nearly two out of three people diagnosed with whooping cough in San Diego County this year were fully immunized. California is in the midst of the worst whooping cough epidemic in 50 years.
The numbers raise questions about how well the vaccine works.
Whooping cough, or pertussis is a contagious upper respiratory illness that in adults can mimic a bad cold. But in babies it can be deadly. Eight babies have died in California from whooping cough since January...

 

UTD = up-to-date with age appropriate pertussis vaccinations by immunization record review or parent report

NUTD = not up-to-date with age appropriate pertussis vaccinations

PBE = personal belief exemption reported by parent and/or physician

UNK = unknown

TDAP DUE = any child 11-18 years old who had only 5 pertussis containing immunizations with no Tdap noted
(source: San Diego County Health & Human Services Agency)

----------------------------------------------------------------------------------------------------------------------------

“I think we have to be honest and try to find out what’s happening.” Dr. Fritz Mooi says, of the Netherlands Center for Infectious Diseases Control.
Mooi believes researchers need to develop new vaccines. But he says the idea that the disease may be mutating and out-smarting current vaccines has been ignored by many public health officials
“That’s not good science and that’s not good public health.”
When KPBS asked the CDC why it believed so many vaccinated people in San Diego county contracted whooping cough - nearly two out of three people - the agency provided a written statement. The CDC says statistically, higher vaccination rates increases the probability a sick person will have been immunized.

CDC Statement On Why Vaccinated People In Calif. Are Contracting Pertussis

Vaccines for pertussis are very effective, but no vaccine protects forever in 100 percent of those vaccinated. Protection wanes over time, which is the reason for intermittent “booster doses.” High vaccination coverage in communities and in families also protects others, including those who are too young to be vaccinated or whose immunity from vaccination has waned.
CA is experiencing a significant increase in pertussis circulating in the community. That disease pressure is causing more fully vaccinated and recently vaccinated people to become infected than in a typical year. It does not mean the vaccine is not working. Rather, the higher the vaccine coverage, the higher the proportion of cases who have been vaccinated. This is commonly misinterpreted to mean that a vaccine is not working, when in fact it means that coverage is high.

Draft Report: Independent investigation of WHO's handling of swine flu pandemic

The "Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009"  was charged with assessing the usefulness of existing International Health Regulations in light of the H1N1 swine flu pandemic, improving preparedness, and evaluating WHO's response to the swine flu pandemic.  Thus much of its draft report speaks to increasing the capacity to manufacture vaccines, expediting the process of sharing vaccines, and obtaining money to fund vaccines in future.  Liability issues were one impediment to sharing (countries needed to indemnify manufacturers from liability before they could receive vaccines).  And the report stated that no evidence of WHO malfeasance (acting on behalf of manufacturers rather than governments and populations) had been seen.

But the report's criticisms of WHO's process got to the heart of what was wrong.  Here are excerpts:

• Even if the definition of a pandemic depends exclusively on spread, its degree of severity affects policy choices, personal decisions and the public interest... The degree of severity of
  the pandemic was very uncertain throughout the summer of 2009, well past the time, for example, when countries would have needed to place orders for vaccine.
• Inadequately dispelling confusion about the definition of a pandemic. One online WHO document described pandemics as causing “enormous numbers of deaths and illness”, while the official definition of a pandemic was based only on the degree of spread. 
• A pandemic phase structure that was needlessly complex.
• Continued counting of cases yielded less useful information than would have been provided by rates of hospitalization, complications and death in countries affected early on in the pandemic.
• The decision to keep confidential the identities of Emergency Committee members.
• Lack of a sufficiently robust, systematic and open set of procedures for disclosing, recognizing and managing conflicts of interest among expert advisers.
• At a critical point of decision-making about the pandemic (moving from Phase 4 to 5), conferring with only a subset of the Emergency Committee rather than inviting input from the full Emergency Committee. 
• Discontinuing routine press conferences focused on the evolving pandemic was ill-advised.
• Lack of a cohesive, overarching set of procedures and priorities for publishing consistent and timely technical guidance...

The final report is due out in May.

Adverse events following flu vaccination in Australia/ BMJ

Data suggest that children may have been hospitalized for post-swine flu vaccination seizures at a rate 2-6 times greater than their rate of hospitalization for swine flu disease.  Data are lacking on other post-vaccination side effects that might also occur. 

I suggest you read this short BMJ piece by authors Peter Collignan, Peter Doshi and Tom Jefferson in its entirety online.  Excerpts follow:

In Australia last year, one febrile convulsion occurred for every 100 to 200 young children vaccinated with CSL's influenza vaccine (2,3,4). Now in the US there have been similar concerns. A recent analysis of the American experience reported a rate of 60 seizures per 100,000 influenza vaccinations when given together with conjugated pneumococcal vaccine (5). However this is likely to under-estimate the true rate. One post-marketing vaccine safety study showed reports of febrile seizures admitted to hospital, was 5 times lower with passive surveillance (6)... in Australia's recent experience, 38% of children with febrile convulsions following vaccination (19 of 56) were admitted to hospital (4)...

In Australia in 2009, during winter when young children (0-4 years) were first hit with the new H1N1 strain, the admission rate for influenza was 57 per 100,000 (8). In the US, CDC says that influenza results in hospitalization for approximately 20 per 100,000 children aged 2 to 5 years (9), but vaccine-induced febrile convulsions resulting in hospitalization in US young children, likely occurred at a rate of 114 per 100,000 children vaccinated . According to the FDA, a "serious adverse event" is defined as hospitalization that results from a vaccine adverse event (10). Thus vaccinating young children without risk factors likely caused more serious adverse events than disease from the new "pandemic" itself.

There is poor safety data available for other serious adverse events that might occur in young children in addition to febrile seizures (11)...  In 2005, when a new study demonstrated that influenza vaccines were not saving elderly lives (16), many argued that this underscored the importance of vaccinating more children (17). Yet we have no evidence demonstrating that children are benefiting from this strategy but do have evidence that these vaccines are hospitalizing children...

UK Department of Health Suggests End to Pneumococcal Vaccine Program in Elderly/ UK Dept. Health

Professor David Salisbury, the Director of Immunisation for the UK Department of Health, wrote to colleagues/stakeholders on March 16 suggesting that routine pneumococcal immunisation in the over-65 age group be ended, and asking for their views before making a final decision on the program.  Ending routine vaccinations in the elderly is the recommendation of the Joint Committee on Vaccination and Immunisation, an independent advisory committee of vaccine experts to UK government ministers.

The committee made several important points:

• There had been no decrease in invasive pneumococcal disease since routine vaccinations were begun in 2003 [this refers to pneumonia, meningitis and sepsis--Nass]
• Vaccine effectiveness is poor in the over-65 age group
• Revaccination did not help, and may have led to a poorer response due to "immune hyporesponsiveness"

At the same time, vaccination may be useful for persons at increased risk of pneumococcal disease, and vaccination recommendations for those under 65 are not affected by this guidance.

Being an observer of the rush to add vaccines to the list of approved medications before there is adequate safety and efficacy data, and then institute their widespread use, this recommendation adds a breath of fresh air to the conversation on vaccines' net benefits.

To my knowledge, this is the first time a standard vaccine program will be ended in the UK.  The Hepatitis B vaccine program ended in France in the mid 1990s after half the population was vaccinated.  The Rotavirus vaccine program ended in the US in 1999, but restarted recently with another version of the vaccine.  The 1976 swine flu program ended precipitously.  Each vaccine program ended due to unacceptably high rates of serious adverse reactions.  I am not sure there are data on how effective these programs were at preventing disease, though swine flu never became an epidemic in 1976, never spread beyond Fort Dix, and the vaccine program was entirely unnecessary.

Acknowledgment that revaccination may actually increase the risk of pneumococcal disease is welcome.  Several animal vaccines in widespread use were found to increase the disease they were meant to prevent, and I have wondered whether any human vaccines may have done the same thing.

Evidence from Hong Kong and Canada that being vaccinated for seasonal influenza in 2008 was associated with twice the risk of becoming ill with H1N1 swine influnza in 2009-10 suggests that the same problem may be associated with human vaccines.

Using antibody levels (serology) to predict vaccine efficacy against disease, as is often done today, instead of looking for cases of disease prevented, both overstakes vaccine efficacy and masks any possible effect on disease promotion by a vaccine.  University of Michigan researchers Monto, Petrie et al. have just published a nice piece on how influenza efficacy is overstated by serologic tests.

Let's vaccinate against a nonexistent flu virus: the "preemptive strike" rears its head again/ BBC

UPDATE:  I just learned that in 2008 GSK obtained European regulatory approval to market a so-called "Prepandemic" Vaccine for H5N1 avian flu.  This virus is not circulating in humans.  The theory behind the vaccine is that if a bird flu virus emerged to cause a pandemic, the GSK vaccine is likely to be somewhat similar to it, and might provide partial immunity.  Such immunity could then be theoretically boosted by a more specific vaccine, made to order for the specific disease-causing virus. 

However, it remains more likely than not that a vaccine for a new pandemic would not be available until 4-6 months or more after the pandemic was identified, likely too late to have much effect.  This happened for the 2009 swine flu pandemic.  The swine flu vaccine was probably only needed for small numbers of people who were at particularly high risk of  severe sequelae from the virus.  The European Parliament now suggests that the death rate in Europe from swine flu was only 1/10th as high as from an average seasonal flu.  This is because those over 50 were, in large part, already immune.

From the BBC:

Governments should launch a vaccination programme now to guard against a possible H2N2 flu pandemic, according to an article in the journal Nature.

The US authors say immunity to the H2N2 flu strain is very low in people under the age of 50. But a safe vaccine already exists after an H2N2 outbreak in the 1950s and '60s.  They say that vaccinating now could save billions of dollars if a pandemic does develop.

Dr Gary Nabel and colleagues from the Vaccine Research Centre in the US say H2N2 has the ability to cause a pandemic in the same way that H1N1 did in 2009.

Between 1957 and 1968, the strain is thought to have caused up to 4 million deaths in a global outbreak, during which time a vaccine was developed.

When the pandemic was over the H2N2 vaccination programme was stopped in the late 1960s, although the virus is still present today among birds and swine...

"Another major influenza pandemic is likely to cost far more and create a much greater health burden than a well-planned pre-emptive programme.

"The US Centres for Disease Control and Prevention estimates that a pandemic outbreak costs the United States between $71 billion and $167 billion."  Dr Wendy Barclay, Chair in Influenza Virology at Imperial College, says the H2 flu virus does pose a credible pandemic threat, as do other strains of bird flu.  But she believes there are some big questions about whether a pre-emptive vaccination programme would be welcomed by the public.

"Now we are in the calm after the storm of that swine flu pandemic, it is timely to open up the debate about pre-pandemic vaccines. As Dr Nabel himself points out in his article, we have to ask whether the public will want or accept a vaccine against a disease that does not at the moment exist.

"Work towards making such vaccines available is ongoing in many laboratories around the world.  "Scientifically we are in a position to be able to offer a good solution, the issues to be decided are of cost and of public attitude."

WHO's response to swine flu pandemic flawed/ AP-WaPo

An excellent piece was published by Agence France Presse.  The article below is by MARIA CHENG, The Associated Press-Washington Post, March 10, 2011:

LONDON -- An expert panel commissioned by the World Health Organization to investigate its handling of the swine flu pandemic has slammed mistakes made by the U.N. body and warned tens of millions could die if there is a severe flu outbreak in the future.

The U.N. health agency established the review committee to evaluate its performance after the 2009 global outbreak of swine flu, or H1N1. In a draft report released on Thursday, the committee said WHO performed well in many ways, but made crucial errors.

The group described WHO's definition of a pandemic and its phases as "needlessly complex," criticized the agency's decision to keep the members of its advisory committee secret, and said potential conflicts of interest among those experts, some of whom had ties to drug companies, were not well managed.

It warned that under WHO's health oversight, the world is not ready to handle a major health disaster in the future . . .

The European Parliament adopted a resolution regarding the Swine Flu pandemic on 3/8/2011.  Its press release reads:

Swine flu: learning from past mistakes
The EU's response to the outbreak of the H1N1 ("swine flu") virus in 2009-2010 is scrutinised and found wanting in a resolution adopted by Parliament on Tuesday which weighs up the cost of vaccination programmes and the relative risks. Suggestions for the future include group purchases of vaccines and tighter safeguards against conflicts of interest.

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

Vaccination programmes

EU Member States' responses ranged from wholesale vaccination programmes to none at all (in the case of Poland). Billions of euros were spent in total. Pointing to the need to reassess vaccination strategies and prevention plans, Parliament urges better cooperation between Member States, such as group purchases of vaccines.

Assessments of and communication about flu outbreaks must be more independent, says the resolution. Safeguards are needed to prevent conflicts of interest. For example, declarations of interest by experts who advise European health authorities should be published. And under EU legislation, full liability for vaccines must lie with the manufacturer, not with Member States.

WHO and EU

The World Health Organisation is asked to review its definition of a "pandemic", to take into account the severity of the illness, not only the spread of a virus. To buttress the EU's own risk assessment capacity, the European Centre for Disease Prevention and Control should be equipped to assess risks independently as well as perform its other tasks, say MEPs.

Information to citizens

Consistent communication by the Member States to their citizens is also crucial, believes Parliament. Governments and the Commission are asked to devise better vaccination and communication strategies to build confidence in public health measures designed to prevent pandemics.

The resolution was adopted by show of hands.

New Suspected Narcolepsy Cases in Finland/ YLE

UPDATE:  Australia has banned 4 flu vaccines and approved 2 for children under age ten, on March 11, 2011.  The 2011 flu vaccine in Australia has identical antigens as last year.  According to The Australian, up to 1 in 100 children under five vaccinated with the CSL vaccine last year suffered a seizure, more than the ninefold increase previously reported (see below).

Now one in 10,000 Pandemrix (GSK)-vaccinated children in Finland have developed narcolepsy.  How does this relate to the ninefold increase in seizures in vaccinated Australian children (using the CSL vaccine)?  We have heard very little about adverse reactions other countries are finding.  Recall that in both Australia, Finland and Sweden, the rate of both seizures (Australia) and narcolepsy (Finland and Sweden) post-vaccination is at least 9 times greater than expected.  From YLE:

About ten new suspected cases of swine flu vaccine-related narcolepsy have been reported in Finland. The National Institute for Health and Welfare (THL) says that altogether 69 suspected cases of narcolepsy or cataplexy have been reported.

The diagnoses for seven of these patients are still in process.

Cataplexy is a severe muscle weakness that can lead to a complete collapse up to 20-30 times a day.

The THL has received 900 complaints regarding the Pandemrix vaccine by Wednesday. Of these, 182 have been classified as serious. Serious cases are those that demand hospital treatment, are life-threatening or could lead to death. The classification for those cases may yet change, since some patient data is missing.