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.