Science in anthrax letter case comes under attack/ Sacramento Bee

David Willman continues to write stories designed to sell his book on Bruce Ivins, and buttress the FBI 's Ivins theory.  I thought journalists were required to at least make a stab at even-handedness, but this once-great journalist didn't bother.

Here's an example:  Willman mentions, then tries to discredit, the paper of Hugh-Jones, Rosenberg and Jacobsen by saying they paid to have it published in an online journal.  Yet today, this is considered the best way for scientists to get their work out to the public in a timely manner, by publishing in PLOS (Public Library of Science) or a similar group of journals.  You pay a small fee to cover secretarial/peer review costs, and in return you get immediate publication after acceptance, and free online availability of the journal for all readers.  Universities generally cover this cost.  Paying the cost does not mean the authors  have bought their way in:  peer review can be even stricter with the online journals than with for-profit journals.  Willman has covered scientific issues for many years, and must have known this.

If you want to read his piece, it is here.

Useless, Expensive Anthrax Vaccine Has Everyone On Board/ The Vaccine Xchange

From the vaccinexchange website, on October 12, 2011 · Leave a Comment

It seems that Emergent BioSolutions, the only manufacturer of the anthrax vaccine in America, has been working aggressively to promote its vaccine throughout our nation. Its efforts have paid off: according to MarketWatch.com, the company has been awarded a $1.25 billion contract to supply the U.S. government with 44.75 million doses of the anthrax vaccine over a five year period.
The government has invested in this vaccine despite the fact that there are numerous problems with the drug itself. As we posted earlier this year, both the vaccine’s safety and its effectiveness are doubtful. In addition, Emergent BioSolutions charges the government an exceedingly high price for the vaccine, with a mark-up of 300%.
Our post drew greatly upon a chilling expose of Emergent BioSolutions’ marketing practices and the ineffectiveness of the vaccine that was released by the Center for American Progress (CAP). Imagine our surprise, then, to hear that, in a move that seems to contradict everything they wrote in that brilliantly researched report, the think-tank is now hosting an event titled “Anthrax Revisited” which asks “Are we better prepared today” to handle biological attacks than we were ten years ago?
This event seems designed to promote the very vaccine that CAP proved was unsafe and ineffectual. In addition, the blurb about the event notes that, “This October marks another solemn 10-year anniversary, as a decade has passed since a series of letters containing anthrax spores infected 17 Americans and killed 5, and introduced the United States to the dangers of a biological attack.” Nowhere is it mentioned that the anthrax “attacks” ten years ago were concluded by the FBI to be an inside job by a scientist who had himself worked on the anthrax vaccine, or that anthrax has over a hundred strains, which should be treated with different antibiotics due to their differences. The EBS vaccine has never been proven to be effective against inhalation anthrax in humans; in fact, the current vaccine has not even been proven effective against skin anthrax. And that doesn’t even take into account the fact that genetic modification could theoretically create an anthrax strain resistant to the vaccine.
The blurb also does not mention why a terrorist organization would stick to anthrax if plotting a bioterrorist attack. Personally, it seems far likelier to me that they would choose a disease for which we have not ordered 44.75 million doses of vaccines, but I am only a lowly civilian.
CAP’s event features a host of panelists who seem to have associations to anthrax vaccine manufacturers and promoters. Panel I, for instance, features Dr. Tara O’Toole, the current Under Secretary for Science and Technology at Homeland Security. Not mentioned is the fact that before her appointment she served as a key adviser for the Alliance for Biosecurity, a group funded by the pharmaceutical industry that lobbied for greater government funding on anthrax vaccines and biodefense research. According to a Washington Times article in 2009, the Alliance spent over $500,000 lobbying Congress and federal agencies (including the Department of Homeland Security, where O’Toole now works) since 2005. O’Toole has also been accused of giving preferential treatment to another anthrax vaccine manufacturer, PharmAthene, and throughout her career in biosecurity, has been known to err on the side of fear-mongering. With all this in mind, it is difficult to understand why CAP decided to ask her to be one of the few panelists at their event.
The two other people on O’Toole’s panel are Senator Tom Daschle and Governor Tom Ridge. Senator Daschle was one of the people targeted during the 2001 anthrax attacks; Governor Ridge was the Secretary of Homeland Security at that time. It is notable that Senator Daschle received the anthrax letter shortly after challenging the anthrax vaccine immunization program. As a result of the anthrax attacks, the anthrax vaccine wasmade widely available to Capitol Hill workers – a decision that Governor Ridge must surely have been involved in making.
The second panel at CAP’s event features James Davis, Executive Vice President of Human Genome Sciences, manufacturer of an anthrax treatment drug, as well as Thomas Inglesby, from the Center for Biosecurity at the University of Pittsburgh Medical Center, who has written a number of articles promoting the vaccine as safe and effective despite the significant amount of contradictory data. He has also frequently collaborated with Dr. O’Toole, whose dubious credentials are noted above. The last panelist is Jeff Levi of Trust for America’s Health, who seems to be on boardwith fear-mongering in favor of vaccines in the event of an attack.
Looking at all of this, it seems clear that CAP has done a sudden about-turn on the issue of the anthrax vaccine. How could they change so dramatically in such a short time? Well, just keep in mind that Emergent BioSolutions and Pharma in general forms a powerful lobby. It is unfortunate that we have lost their voice, because we need more of the kind of research they did only a year ago.

FBI's case against anthrax suspect rife with questions/ Kansas City Star (McClatchy)

In case you were looking for a synopsis of the important parts of the Frontline anthrax letters program, here it is.  This piece was written by the TV show's investigative team, and details important flaws in the FBI's case.  Definitely worth a read, and maybe a reread, to feed your anthrax letters obsession.

Watch Frontline's "The Anthrax Files"/ PBS

See Part I of The Anthrax Files.  This terribly important 1 hour documentary uncovered new evidence in the case.  Additional videos related to the case are accessible at the site.  Enjoy.

New California law lets 12-year-olds consent to "preventive care for STDs" aka Gardasil/ LA Times

From the LA Times:

California Gov. Jerry Brown stepped into the middle of a debate over parental rights Sunday by signing legislation  giving children 12 or older the power to consent to medical care involving the prevention of sexually transmitted disease.

Asssemblywoman Toni Atkins (D-San Diego) sponsored AB 499 with the aim of providing young people with timely preventative treatment, including the human papillomavirus [HPV] vaccine that proponents say can reduce the risk of certain cancers, precancerous cervical cell changes and genital warts.

The measure was backed by groups including the California STD Controllers Assn., the Health Officers Assn. of California, ACT for Women and Girls and the American Civil Liberties Union.

The bill was opposed by the California Catholic Conference, which opposed previous measures that allow minors to consent to certain treatments without the involvement of parents.

That group wrote to legislators that "this bill is dangerous because it expands a faulty law which assumes that children know better than their parents and because it will allow minors access to HPV vaccines which may cause them permanent harm."

And who will be able to link the Gardasil shot to any adverse side effects, when the shots are "secret":  obtained in the absence of parental consent, so the pre-teens and teens would not have to disclose sexual activity to their parents?  See"Gardasil Side Effects Tough to Monitor" in US News. 

Who pays for treatment of the side effects?  Since sexually transmitted diseases should not be getting transmitted at schools,  why has the state of California chosen to bypass parental consent?  What is its interest in this matter?

A national organization of female state legislators has been blessed by Merck largesse since at least 2004.  The organization, Women in Government, wants to wipe out cervical cancer, using Gardasil as its primary weapon, while becoming a well-funded organization in the process.  Here is how Women in Government wrap themselves in the cloak of science.  Here you can see how they pay lip service to other cancers, but cervical cancer and Gardasil vaccine are the major issues of concern to this group.  Here you can see how Women in Government have mapped out a plan to increase (and government fund) Gardasil vaccinations state by state--except some of the links have been removed.

When candidate/Governor Rick Perry of Texas mandated Gardasil vaccine in 2007 for all girls entering sixth grade, the Associated Press/MSNBC ran an excellent piece pointing out how Merck had funded this initiative through funding Women in Government and using well-placed lobbyists.  Here's an excerpt:

Laws could mean billions in sales

The New Jersey-based drug company [Merck] could generate billions in sales if Gardasil — at $360 for the three-shot regimen — were made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no serious side effects. [This claim is questionable--Nass]
Cathie Adams, president of the conservative watchdog group Texas Eagle Forum, said the relationship between Merck and Women in Government is too cozy.
“What it does is benefit the pharmaceutical companies, and I don’t want pharmaceutical companies taking precedence over the authorities of parents,” she said.
Adams said Merck’s method of lobbying quietly through groups like Women in Government in addition to meeting directly with legislators are common in state government but still should raise eyebrows. “It’s corrupt as far as I’m concerned,” she said...

But Merck has doubled its spending on lobbyists in Texas this year, to between $150,000 and $250,000, as lawmakers consider the vaccine bill for girls entering the sixth grade.

The drugmaker has hired one of the state’s most powerful lobbyists, Mike Toomey, who once served as Republican Gov. Rick Perry’s chief of staff and can influence conservatives who see him as one of their own...

Drug-industry analyst Steve Brozak of W.B.B. Securities has projected Gardasil sales of at least $1 billion per year — and billions more if states start requiring the vaccine. “I could not think of a bigger boost,” he said.

Frontline's 'Anthrax Files' takes hard look at FBI role in suicide of Ft. Detrick scientist: Report asks if FBI overstated case against Frederick resident Bruce Ivins/ PBS Frontline

David Zurawik at The Baltimore Sun writes about tomorrow's important Frontline story on Bruce Ivins and the anthrax letters.  This will be the first episode.

Nobody does investigative journalism on TV like Public Television's "Frontline" -- nobody, and week in, week out that includes "60 Minutes."

And Tuesday night at 9, the venerable series revisits Ft. Detrick in Frederick, Maryland, and the case of anthrax researcher Bruce Ivins who killed himself in 2008 as the FBI zeroed in on him as its prime suspect in the case of deadly envelopes of anthrax sent through the mail.

According to this hard-edged report done in partnership with McClatchy Newspapers and Propublica, the FBI did more than zero in. Under tremendous pressure to solve the case that started in 2001 with anthrax mailed to U.S. senators and network anchors, the agency squeezed Ivins hard -- using every trick in the book to get a confession out of him even as he insisted on his innocence to the end.

Ivins was a troubled guy with some distinctive kinks, the report acknowledges, but even FBI consultants in the case now admit that the agency overstated its evidence and never found a smoking gun to prove the researcher's guilt. In fact, evidence was revealed last summer that shows Ivins did not have  the equipment needed to make the powdery kind of anthrax sent through the mail. That didn't stop the FBI then -- or now -- in acting like it found its man.

"The Anthrax Files" is chilling report on several fronts.

First, it is a reminder of what paranoid and scary times have been living though since 2001 when the envelopes first appeared -- and the horrible events we just commemorated took place on September 11. These are indeed dark times, and with the economy getting worse and worse, there seems to be no light anywhere in sight.

Second, the report shows how a federal agency can shred an individual's life -- with or without the proper evidence to convict. "The Anthrax Files" suggests that anyone with the psychological issues Ivins had might have cracked under the weight of the FBI invading his privacy, exposing his secrets and  ultimately getting him kicked out of the community of researchers that he called home at Ft. Detrick.

And finally, this is a chilling report, because if Ivins was not the person who sent the anthrax, then that killer is still on the loose. And we are left with an FBI that not only failed to solve such a huge case, but overstated and maybe lied about what it did accomplish.

"The Anthrax Files' premieres at 9 p.m. Tuesday on MPT (Channel 22).

Scientists’ Analysis Disputes F.B.I. Closing of Anthrax Case/ NY Times

William Broad and Scott Shane have written a very useful NYT piece on the anthrax letters.  It discusses a new academic paper by Martin Hugh-Jones, Stuart Jacobsen and Barbara hatch Rosenberg, which explores the meaning of the tin and silicon found in the anthrax spore preparation of the anthrax letters.

A decade after wisps of anthrax sent through the mail killed 5 people, sickened 17 others and terrorized the nation, biologists and chemists still disagree on whether federal investigators got the right man and whether the F.B.I.’s long inquiry brushed aside important clues.

Now, three scientists argue that distinctive chemicals found in the dried anthrax spores — including the unexpected presence of tin — point to a high degree of manufacturing skill, contrary to federal reassurances that the attack germs were unsophisticated. The scientists make their case in a coming issue of the Journal of Bioterrorism & Biodefense.

F.B.I. documents reviewed by The New York Times show that bureau scientists focused on tin early in their eight-year investigation, calling it an “element of interest” and a potentially critical clue to the criminal case. They later dropped their lengthy inquiry, never mentioned tin publicly and never offered any detailed account of how they thought the powder had been made...

Both the chairwoman of a National Academy of Science panel that spent a year and a half reviewing the F.B.I.’s scientific work and the director of a new review by the Government Accountability Office said the paper raised important questions that should be addressed.

Alice P. Gast, president of Lehigh University and the head of the academy panel, said that the paper “points out connections that deserve further consideration.”

Dr. Gast, a chemical engineer, said the “chemical signatures” in the mailed anthrax and their potential value to the criminal investigation had not been fully explored. “It just wasn’t pursued as vigorously as the microbiology,” she said, alluding to the analysis of micro-organisms. She also noted that the academy panel suggested a full review of classified government research on anthrax, which her panel never saw.

In interviews, the three authors said their analysis suggested that the F.B.I. might have pursued the wrong suspect and that the case should be reopened. Their position may embolden calls for a national commission to investigate the first major bioterrorist attack in American history...

In a reprise of the DOJ's "hang tough and deny" MO:

Dean Boyd, a Justice Department spokesman, said the paper provided “no evidence whatsoever that the spores used in the mailings were produced” at a location other than Fort Detrick. He said investigators believe Dr. Ivins grew and dried the anthrax spores himself.

“Speculation regarding certain characteristics of the spores is just that — speculation,” Mr. Boyd said. “We stand by our conclusion.”

The tin is surprising because it kills micro-organisms and is used in antibacterial products. The authors of the paper say its presence in the mailed anthrax suggests that the germs, after cultivation and drying, got a specialized silicon coating, with tin as a chemical catalyst. Such coatings, known in industry as microencapsulants, are common in the manufacture of drugs and other products.

“It indicates a very special processing, and expertise,” said Martin E. Hugh-Jones, lead author of the paper and a world authority on anthrax at Louisiana State University. The deadly germs sent through the mail to news organizations and two United States senators, he added, were “far more sophisticated than needed.”

In addition to Dr. Hugh-Jones, the authors of the new paper are Barbara Hatch Rosenberg, a biologist, and Stuart Jacobsen, a chemist; both have speculated publicly about the case and criticized the F.B.I. for years.

In 2008, days after Dr. Ivins’s suicide, the bureau made public a sweeping but circumstantial case against him. Last year, the bureau formally closed the case, acknowledging that some scientific questions were unanswered but asserting that the evidence against Dr. Ivins was overwhelming.

Investigators found that the microbiologist had worked unusual late-night hours in his lab in the days before each of the two known anthrax mailings in September and October 2001; that he often mailed letters and packages under assumed names; that he had a history of homicidal threats and spoke of “Crazy Bruce” as a personality that did things he later could not remember.

Dr. Ivins had hidden from family and friends an obsession with a sorority — Kappa Kappa Gamma — with an office near the Princeton, N.J., mailbox where the letters were mailed. The F.B.I. recorded Dr. Ivins’s speaking ambiguously to a friend that he did “not have any recollection” of mailing the letters, that he was “not a killer at heart” and that “I, in my right mind, wouldn’t do it.”

Yet no evidence directly tied Dr. Ivins to the crime. Some of the scientist’s former colleagues have argued that he could not have made the anthrax and that investigators hounded a troubled man to death. They noted that the F.B.I. pursued several other suspects, most notoriously another former Army scientist, Dr. Steven J. Hatfill, whom the bureau eventually exonerated and paid a $4.6 million legal settlement.

In its report last February, the National Academy of Sciences panel sharply criticized some of the F.B.I.’s scientific work, saying the genetic link between the attack anthrax and a supply in Dr. Ivins’s lab was “not as conclusive” as the bureau asserted.

If the authors of the new paper are correct about the silicon-tin coating, it appears likely that Dr. Ivins could not have made the anthrax powder alone with the equipment he possessed, as the F.B.I. maintains. That would mean either that he got the powder from elsewhere or that he was not the perpetrator.

If Dr. Ivins did not make the powder, one conceivable source might be classified government research on anthrax, carried out for years by the military and the Central Intelligence Agency. Dr. Ivins had ties to several researchers who did such secret work.

The Government Accountability Office, the investigative arm of Congress, is conducting its own review of the anthrax evidence. Nancy Kingsbury, the official overseeing the project, said the agency had spoken with the paper’s authors and judged that “their questions are reasonable.”

Beyond the world of forensics, tin is a humdrum additive used to kill micro-organisms in products like paint, wood preservatives and even toothpaste. But microbiologists say that the nutrients and additives used to grow Bacillus anthracis, the anthrax bacteria, are typically free of tin.

So in late 2002, when the F.B.I. found significant quantities of tin in the mailed powders, it set out to find its source. By 2003, the bureau was calling tin “an element of interest” — echoing its terminology for human suspects — according to disclosures culled from 9,600 pages of F.B.I. documents by The Times.

Over the years, the bureau performed hundreds of tests to explore tin’s use in microbiology and significance in the attack germs. It also hunted for clues to how the spores had become laced with silicon, which the United States had used decades ago as a coating in germ weapons. In 2005, scientists at an internal F.B.I. symposium called tin a possible fingerprint of the attack germs.

After that, the forensic clue disappeared from public discussion, except for a passing mention in a 2009 press release. “Although the chemical fingerprint of the spores is interesting,” the release said, “it was not relevant to the investigation.”

In the end, the F.B.I. — without alluding to its private tin labors — declared publicly that the attack germs had no special coating, saying that conclusion supported its finding that Dr. Ivins had grown and dried the spores alone, using standard equipment in his lab at Fort Detrick.

Several anthrax scientists who reviewed the new paper at the request of The Times said they believed it neglected the possibility that the tin and silicon were meaningless contaminants rather than sophisticated additives.

Johnathan L. Kiel, a retired Air Force scientist who worked on anthrax for many years, said that the spores “pick up everything” and that the silicon might be residue of a commercial product used on laboratory glassware to keep spores from sticking. He said tin might even be picked up from metal lab containers, though he has not tested that idea.

“It doesn’t have to be some super-secret process,” Dr. Kiel said. Other experts suggested that the tin might have come from anti-foam products, disinfectants or water.

The trouble with such conjecture is that the F.B.I. spent years testing for tin in microbiology lab supplies — and reported none, according to bureau documents.

Dr. Gast, the head of the National Academy of Sciences panel, noted that her group strongly recommended that future investigations of the attacks examine the government’s classified work on anthrax.

She called access to secret records “an important aspect of providing more clarity on what we know and what we don’t know.”  

CIA's vaccine ruse in Pakistan carries fallout/ LA Times

From the LA Times:

The phony campaign was aimed at helping find and kill Osama bin Laden, but the doctor involved now faces treason charges, and real immunization workers say Pakistanis don't trust them.

...Aid teams heading polio vaccination drives reported that more parents were refusing to allow their children to be vaccinated after news of the CIA ruse.

The phony campaign's repercussions on polio vaccinations is particularly alarming because Pakistan is one of four countries where the disease is still considered endemic, according to the World Health Organization. This year, 100 new cases of polio have been recorded in Pakistan, according to WHO statistics...

UW Professors: Accused Anthrax Killer Couldn’t Have Done It

 From the University of Wyoming:

...  "The scientific evidence clearly shows that the (anthrax) wasn't produced in our laboratory (USAMRIID)," the two UW professors say. "The FBI based part of its case on unusual activity that took place in our lab for one week. There is no way he could produce that amount of spores in our lab during that time."
Other independent laboratories couldn't produce anthrax under similar lab conditions, and the FBI could not recreate the attack strain, Adamovicz says.
"The FBI's own evidence suggested a more advanced laboratory produced it," he says...

Calculating the risk and benefit of the Pandemrix vaccine program for swine flu

Let's do a back-of-the-envelope risk-benefit calculation on swine flu vaccine:


In 2009-10, 44 Finns of all ages died of swine flu.  [With 5.3 million Finns, this is one death per 120,000 people of all ages.]


About half the population of Finland received Pandemrix.  Had the vaccine been given before the pandemic struck (a near impossibility) and had it been 100% effective (also an impossibility) it would at the very best have saved the lives of 44 people.


Seventy-nine children developed narcolepsy following Pandemrix vaccinations. [This is about one case per 17,000 children.] If the whole population received Pandemrix, probably at least 79 more children would have developed severe cases of narcolepsy (RR 12.7), and likely there would be additional adult cases as well, which were not deemed statistically significant, thus far.  There would also have been a few extra cases of Guillain Barre Syndrome (RR (1.77), and probably additional cases of other autoimmune disorders, which have not been identified because the relative risk has not been sufficiently higher than expected to be noticed.


If the vaccine had been developed and administered before there were any swine flu cases in Finland, and if it had been 100% effective and prevented every death, you would still be trading seven children developing severe narcolepsy for every person whose life was saved by vaccination.

Since Pandemrix was far from 100% effective (its effectiveness depends on the age and health status of the person being inoculated, and whether they were already immune), the health of ten, twenty, thirty or more children was probably exchanged for each life, of any age, that might have been saved by Pandemrix in Finland.  


And some people who developed additional illnesses, such as Guillain Barre Syndrome, also had their health traded for the few lives the vaccine may have saved.  Now add in the costs of purchasing and administering the vaccine, and the lifetime costs of treating and compensating those who became ill.  Do you think this is a valid trade-off?  How should public health systems handle pandemics in future?


The CDC and WHO are carefully watching out for new viruses that might cause future pandemics, so we will be prepared ahead of time, right?  But according to Dr. Steve Salzberg in Forbes, nobody is watching:

...  The 2009 pandemic originated in pig farms in Mexico. We don’t know precisely where it made the first leap into humans, but it appears that two different strains joined together in a pig somewhere to create the new H1N1. The flu has a nasty habit of jumping the species barrier, hopping to humans from both pigs and chickens.
So now that we know all this, next time will be different, right? The world’s influenza scientists are monitoring pigs and chickens closely now, keeping a close eye on any new flu strains. Right? RIGHT???
Er, no. Not exactly. For one thing, surveillance in pigs appears to be nonexistent. I checked to see how many flu sequences from pigs in Mexican have been desposited in the public archive at GenBank since 2009 (using this terrific database). The result? One, in 2009. Nothing from 2010 or 2011. Hello, is anyone awake at the CDC and the WHO?...

Why did Finland and Sweden have many narcolepsy cases, but we are not hearing about them elsewhere?  The most likely reason is that Sweden and Finland vaccinated a much higher percentage of their population than other countries, causing a much greater percentage of adverse reactions.  I have written previously about the difficulty learning how many Americans were vaccinated.  In Israel, 11.6 percent of the population took the shots against swine flu. In Spain, 10 percent were vaccinated, while in Greece, a mere 3 percent got the shots. In Sweden, by comparison, 60 percent of the population were vaccinated, and in Finland, 50 percent.


Meryl Nass, MD

From Finland's National Institute for Health and Welfare:

1 Sep 2011

An association between Pandemrix and narcolepsy among children and adolescents in Finland is confirmed.
In its final report, the National Narcolepsy Task Force confirms the tentative conclusion published in its Interim Report last January that the Pandemrix vaccine used in the winter of 2009–2010 contributed to the increased incidence of narcolepsy observed among 4–19-year-olds in Finland. According to the report, the increased risk associated with vaccination amounted to six cases of narcolepsy per 100 000 persons vaccinated in the 4–19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated. No increased incidence of narcolepsy was observed among children under the age of four or among adults over the age of 19.
In all the cases examined, narcolepsy associated with Pandemrix vaccination has been identified in persons who carry a genetic risk factor for narcolepsy. Because of this very strong association with the genetic risk factor which regulates immune responses, narcolepsy is considered an immune-mediated disease.
In approximately one quarter of those who developed narcolepsy following Pandemrix vaccination, the THL Immunology laboratory found antibodies binding to the AS03 adjuvant component of the vaccine. Adjuvants containing squalene have not previously been reported to induce the production of antibodies. (Depends what literature you read--Nass)  The significance of this preliminary observation will be the subject of further research.
Tests on viral antibodies indicated that less than 10 per cent of the children and adolescents who developed narcolepsy had been infected with swine flu. Swine flu infection thus does not appear to play a significant role or be in joint effect with the Pandemrix vaccine in the onset of narcolepsy...
By 25 August 2011, the National Vaccine Adverse Event Register maintained by THL had received notifications of 98 cases of narcolepsy subsequent to vaccination with Pandemrix; 79 of the subjects were between 4–19 years old at the time of vaccination. Narcolepsy was associated with cataplexy in 78 of the cases. Most of the persons affected developed symptoms within a couple of months after receiving the vaccination...
The Pandemrix vaccine was used in the winter of 2009–2010 to prevent the swine flu epidemic. About half of the Finnish population chose to be vaccinated.  There were 44 deaths from swine flu confirmed by laboratory tests. A significant number of severe cases were prevented during the 2009–2010 season, even if vaccines were given at about the same time as the epidemic reached Finland.  (Perhaps, but vaccine was given late, and no data are given--Nass)
During the influenza season 2010–2011, 13 succumbed. Most of these were unvaccinated. Combining the data on morbidity and mortality with data on vaccinations in the 2009–2010 pandemic season indicate that a swine flu vaccination taken in the pandemic season had provided 75–88 per cent protection against the swine flu virus in winter 2010–2011. Based on these vaccine effectiveness figures, it has been estimated that during the first wave in 2009-2010, the swine flu vaccine prevented approximately 40 000 cases of swine flu, and during the second wave in 2010-2011, another 40 000 cases of swine flu... (But are these numbers ignoring the fact that most people had already  developed immunity during the previous year of the swine flu pandemic? --estimated at over 60% of the US population by NIH researchers.  The stronger, natural immunity of people who were exposed but later vaccinated, is likely being counted as vaccine-induced protection--Nass)

© THL 2011    -     National Institute for Health and Welfare  |  P.O. Box 30, FI-00271 Helsinki, Finland  |  +358 20 610 6000

Finland vows care for narcolepsy kids who had swine flu shot/ AFP

From Agence France Presse:

HELSINKI — The Finnish government and major insurance companies announced Wednesday they will pay for lifetime medical care for children diagnosed with narcolepsy after receiving the swine flu vaccine.

"The compensation will provide much-needed financial assistance for the families, although it cannot take away the emotional distress caused by this condition," Social Services and Health Minister Paula Risikko said in a statement.

Finnish and international researchers recently found a conclusive link between the Pandemrix swine flu vaccine and new cases of narcolepsy, a chronic nervous system disorder which causes people to often uncontrollably fall asleep.

The Finnish Pharmaceutical Insurance Pool (LVP), which represents insurance companies, said Wednesday it would honour all insurance claims in this category.

LVP said it would review each claim individually to calculate the scope of the payout.

The Finnish government meanwhile agreed to cover any medical costs exceeding the insurance claims.

In Finland, 79 children between the ages of four and 19 developed narcolepsy after receiving the Pandemrix vaccine in 2009 and 2010.

Of these cases, an unusually high number, 76, also suffered from bouts of cataplexy, suffering hallucinations or paralysing physical collapses, according to Finnish research.

From Finland's YLE:

The amount of compensation has not yet been set, as each case will be investigated individually. Medical care, medication and travel costs are eligible for reimbursement, along with other costs incurred as a result of narcolepsy caused by the Pandemrix vaccinations.

Where the victim is a child, loss of earnings compensation could be paid to parents. After the 30-million euro fund for compensation is exhausted, the state will take responsibility for funding payouts.

The link between Pandemrix and subsequent onset of narcolepsy has been supported by research from Finland’s Institute for Health and Welfare (THL). 

UPDATE:  Sweden also begins compensating kids for narcolepsy.

The first children in Sweden who fell ill with the sleeping disorder narcolepsy after being given the swine flu vaccination Pandemrix, have been awarded 50,000 kronor ($7,340) in compensation.

“It is difficult for me to say if 50,000 kronor is a lot or too little. We have nothing to compare it to, “ said Herman Afzelius, father of 10-year-old Arvid, who suffers from the disease after getting the swine flu shot, to daily Dagens Nyheter (DN).

In total, 118 children and youngsters have reported being struck by the disease after the vaccination drive in 2009 and 2010.

Twelve families have so far been told they will receive compensation, according to DN.

According to Anders Öhlen, the CEO of insurance company Läkemedelsförsäkringen, the amount is in line with other severe illnesses, such as deafness or paralysis. . .

When the children turn 18, a new medical assessment will decide if they are eligible for any other financial recompense...

Wall Street hits us with a permanent Katrina/ thx to Mark Crispin Miller

Editorial: Anthrax Attacks Still A Mystery After 10 Years/ Hartford Courant

From the Courant:

October 5, 2011

After the World Trade Center was destroyed 10 years ago, death arrived once again — in the mail. Anthrax, a terrifying and deadly bacterium that multiplies rapidly when inhaled, began to appear in letters sent to a variety of places. Among these were the New York Post, the offices of two U.S. senators, the office of NBC News anchor Tom Brokaw, and, bizarrely, the home of 94-year-old Ottilie Lundgren of Oxford.

Mrs. Lundgren and four others died; 17 were injured. Thousands were exposed and had to take powerful antibiotics. The government seemed paralyzed. The FBI investigators careened from one false lead to another. After 10 years, 9,000 interviews and 6,000 subpoenas, the anthrax attacks are still unsolved

For years, the FBI harassed scientist Steven Hatfill as the only suspect in the case until the agency was forced to apologize and award him $5.8 million for slandering him and destroying his career. After Army microbiologist Bruce Ivins committed suicide in 2008, the FBI announced that he was the likely source of the anthrax attacks. But the agency's case is circumstantial and important questions remain unsolved:

• The anthrax spores were "weaponized" with a high percentage of silicon, making the bacteria even more lethal. Yet there's no evidence that Dr. Ivins either had the equipment or was capable of the elaborate process necessary to add the silicon.
• One of the 9/11 hijackers, Ahmed Alhaznawi, reported to a Florida hospital with a dark wound that the attending physician told the FBI was consistent with cutaneous anthrax, which causes skin lesions.
• The cave at Tora Bora where Osama bin Laden hid for a time twice tested positively for the same strain of anthrax found in the letters, according to Pulitzer-prize winning author Laurie Garrett, author of "I Heard the Sirens Scream: How Americans Responded to the 9/11 and Anthrax Attacks."

The Government Accountability Office is currently examining the FBI's botched investigation. U.S. Rep. Rush Holt, from whose New Jersey district the perpetrator mailed the anthrax-laced letters, has for years proposed congressional hearings into the anthrax attacks. So far, nobody's listened.

Such hearings are the least that should occur. A decade without clear answers is infuriating — and unacceptable.

More Anthrax Vaccine Stockpiled for Civilians: Cost $1.25 Billion

Read it an weep; each American is paying $4.00 for their share of this stockpile of poison.

press release

Oct. 3, 2011, 7:00 a.m. EDT

Emergent Biosolutions Receives Award to Supply 44.75 Million Doses of BioThrax to US Government Over Five Years

ROCKVILLE, Md., Oct 03, 2011 (BUSINESS WIRE) -- Emergent BioSolutions Inc. /quotes/zigman/429174/quotes/nls/ebs EBS +11.15% today announced that, in response to solicitation RFP-2011-N-13414, it has received an award to supply the U.S. government with 44.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed) over a period of five years for a total value of up to $1.25 billion. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection...

This year's flu vaccine: Setting things straight

There is so much written that is dead wrong about this year's flu vaccine,  another post is needed.  Here are some facts:


1.  This year's flu vaccine is the same as last year's vaccine.  If you are healthy and got the vaccine last year, you probably still have antibodies against all 3 strains.

2.  The antigen used for the 2009 Swine Flu vaccine was an H1N1 hemagglutinin.  It was used as a single antigen vaccine in 2009, but was included as one of the three hemagglutinin antigens in 2010 and 2011.  In 2009, in some countries, a novel adjuvant was added to the antigen (either MF59 [Novartis] or ASO3 [Glaxo]) to increase the immune response.

In the US, for example, which used no adjuvant, the 2010 and 2011 flu vaccines contain the 2009 swine flu vaccine, plus two more antigens.  Therefore, claims that this year the vaccine is entirely different are misleading.

In countries like Ireland and England, which used the ASO3 adjuvant in 2009, the current flu vaccine differs from 2009 because it has no ASO3.  But it does have the same hemagglutinin antigen.  [I mistakenly wrote adjuvant instead of antigen earlier.]

Narcolepsy cases have occurred after both adjuvanted and unadjuvanted swine flu vaccines were given.

3.  How effective is the vaccine?  Although 70-90% of recipients develop antibodies, the amount of flu that is prevented is questionable.  Remember that studies from Hong Kong and Canada found that if you got flu vaccine in 2008, you were about twice as likely to become ill with a swine flu infection the next year?  So the 2008 vaccine had negative efficacy for the 2009 influenza. (Being vaccinated in 2008 made it more likely that recipients would get sick from flu the next year.  This is not strange, as some vaccines, in the past, have been found to enhance infection. )

UPDATE: Here is a new article, just published, which supports a causal relationship between getting the 2008 flu vaccine and actually getting sick from swine flu the following flu season.

The effectiveness of the flu vaccine varies from year to year, but it is not very high, and never over 70% for the young and healthy.  It is hard to show any efficacy in the aged.

4.  The reason narcolepsy was discovered to be a side effect of swine flu vaccine in Finland was  because there were 13 times as many cases appearing as usual.  That is 1300% more cases than expected, of a very serious condition that can have lethal consequences.

5.  Was narcolepsy the only serious adverse reaction to swine flu vaccine?  It's unlikely.  There is no data on other side effects, except for Guillain Barre Syndrome (GBS).  Because GBS was caused by the 1976 swine flu vaccine (see prior posts on this from 2009), CDC and FDA promised to look closely for cases when the 2009 swine flu vaccine program was launched.  The same level of scrutiny was not paid to other potential side effects.

You may have seen headlines that swine flu vaccine does not cause Guillain Barre Syndrome; I did, on the same day a report was issued about narcolepsy and the vaccine.  However, It seems swine flu vaccine DID cause Guillain Barre Syndrome after all.  The full text is here, or you can read the abstract below.  CDC calculated it caused 1.77 times as many cases of GBS as expected, or 177%.

MMWR Morb Mortal Wkly Rep. 2010 Jun 4;59(21):657-61.

Centers for Disease Control and Prevention (CDC).

Guillain-Barré syndrome (GBS) is an uncommon peripheral neuropathy causing paralysis and in severe cases respiratory failure and death. GBS often follows an antecedent gastrointestinal or upper respiratory illness but, in rare cases, can follow vaccination. In 1976, vaccination against a novel swine-origin influenza A (H1N1) virus was associated with a statistically significant increased risk for GBS in the 42 days after vaccination (approximately 10 excess cases per 1 million vaccinations), a consideration in halting the vaccination program in the context of limited influenza virus transmission. To monitor influenza A (H1N1) 2009 monovalent vaccine safety, several federal surveillance systems, including CDC's Emerging Infections Program (EIP), are being used. In October 2009, EIP began active surveillance to assess the risk for GBS after 2009 H1N1 vaccination. Preliminary results from an analysis in EIP comparing GBS patients hospitalized through March 31, 2010, who did and did not receive 2009 H1N1 vaccination showed an estimated age-adjusted rate ratio of 1.77 (GBS incidence of 1.92 per 100,000 person-years among vaccinated persons and 1.21 per 100,000 person-years among unvaccinated persons). If end-of-surveillance analysis confirms this finding, this would correspond to 0.8 excess cases of GBS per 1 million vaccinations, similar to that found in seasonal influenza vaccines. No other federal system to date has detected a statistically significant association between GBS and 2009 H1N1 vaccination. Surveillance and further analyses are ongoing. The 2009 H1N1 vaccine safety profile is similar to that for seasonal influenza vaccines, which have an excellent safety record. Vaccination remains the most effective method to prevent serious illness and death from 2009 H1N1 influenza infection; illness from the 2009 H1N1 influenza virus has been associated with a hospitalization rate of 222 per 1 million and a death rate of 9.7 per 1 million population.  [This suggests 3,000 people in the US died from swine flu -- a far cry from the 24,000-45,000 said to die each year from influenza.--Nass]

Narcolepsy and Swine Flu Vaccine: Is this the vaccine we use today?/ BBC

From the BBC:  Link between narcolepsy and flu vaccine investigated 

Health officials are investigating a link between narcolepsy and the Pandemrix vaccine in two people who were treated for swine flu.

Northern Ireland's Chief Medical Officer has confirmed to the BBC, that Northern Ireland had become the latest country to report suspected cases of the sleeping disorder.

Dr Michael McBride said the vaccine was used during the flu pandemic of 2009.

"Let's be clear - this is not the vaccine that we use today," he added...

Let's be clearer in this blog.  The trivalent vaccine used today does include the swine flu (H1N1) hemagglutinin antigen --the main immunizing ingredient in swine flu vaccines.  According to the FDA, the 2011-2012 vaccine's "A/California/7/09 (H1N1)-like virus is the pandemic (H1N1) 2009 influenza virus."  In the UK and many countries, but not the US, the swine flu vaccine used in 2009-10 also contained a novel adjuvant; in the UK this was ASO3.  It is of interest that in one important study, most, but not all cases of post-vaccination narcolepsy were associated with the ASO3-adjuvanted vaccine, while other cases were associated with the plain vaccine...which contained the same ingredients as are found in the current flu vaccine.  So far, neither ASO3 adjuvant nor hemagglutinin antigen has been implicated as "the" cause of the narcolepsy outbreak.  Certainly, the European Medicines Agency has no clue, below:

In the past six months, the number of narcolepsy cases in Beijing in China, and Scandinavian countries including Finland has risen significantly...

With concern growing about the potential side effects of Pandemrix, the vaccine used during the pandemic flu in 2009, the European Medicines Agency completed a review of the drug in July 2011. 

It concluded that the benefits of Pandemrix continued to outweigh its risks, but that it may only be used in people under 20 if the recommended annual seasonal vaccine was not available and if immunization against H1N1 was still needed.  [Would the person who calculated this crazy risk - benefit analysis please stand up?---Nass] 

US Food and Drug Administration lashes pharmaceutical giant CSL over lab practices/ The Australian

for video click here

Despite the report below, CSL is one of six flu vaccine manufacturers licensed to sell flu vaccine in the US in 2011.  The CSL vaccine, Afluria, is labelled for use over 5 years old.  However, the CDC's Advisory Committee on Immunization Practises recommends that Afluria not be used in children aged 6 months through 9 years, because of "increased reports of febrile reactions in this age group."  Why use it at all, when Australia had 9 times the expected rate of febrile seizures from Afluria in early 2010?  Or are the other five brands equally problematic?  Here are the brands and lots released for use by FDA so far this season.

Febrile seizures in small children may not be the only problem with the vaccine.  One must also balance the risk of getting flu, and the benefit from vaccination.  In the US, approximately 100 children die from flu yearly, half of whom have underlying chronic illnesses.  There are about 80 million US children, so yearly deaths from flu are slightly more than one in a million.  It appears that about 64 per million vaccinated children developed narcolepsy in Ireland.  About 90% of new child narcolepsy cases in Finland were due to vaccination. 

UPDATE Oct. 19:  CSL accused of not reporting seizures during its flu vaccine's clinical trial.

US FDA accuses CSL of bad practices

SECRET audits by the powerful US Food and Drug Administration have revealed a multitude of manufacturing flaws at Australia's biggest pharmaceutical company, CSL. The FDA's 2010 and 2011 audits, released to The Australian yesterday after a Freedom of Information request, cite a string of "objectionable conditions and practices" used by CSL to make vaccines.

The FDA allegations - which CSL said yesterday had been or were in the process of being resolved - include the failure of laboratory staff to wear masks while dispensing and mixing vaccines, "deficient" tests to check whether viruses were properly split to prevent side-effects and "inadequate" investigations into product failures.
The FDA documents reveal that CSL took six months to start investigating the cause of mysterious dark particles in the national stockpile of swine flu vaccine.
The most recent audit, in March, branded as "inadequate" CSL's investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine.
Eleven months after Fluvax was banned for young children, the FDA audit discovered CSL had not compiled an investigations report or even designated anyone to be in charge of the investigation.

Australia's pharmaceutical regulator, the Therapeutic Goods Administration, refused to release the findings of its own audits into CSL.
And CSL insisted the FDA audits contained "observations only" rather than any final determination of compliance.
CSL, the privatised Commonwealth Serum Laboratories, has also been under fire this week after being forced to ration supplies of penicillin in its role as sole Australian supplier of the medicine.
The FDA audit findings form the basis of a "warning letter" the US regulator sent to CSL in June, threatening to revoke its US licence if it failed to address outstanding issues.
This year's audit described as "inadequate" CSL's investigation into the high rate of fever and convulsions among children given the Fluvax shot last year. "There was limited analysis of the manufacturing process to determine why there was a substantial increase of adverse-event reports of fever and convulsions in the 2010 southern hemisphere influenza season in comparison to previous seasons. "There was no evaluation of testing of raw material and potential impact on manufacturing," it said.
The audit found 15 lots of a key ingredient in CSL's flu vaccines, the detergent sodium taurodeoxycholate, failed an "identity test" but were used regardless.
The detergent is used to split the flu viruses used to make vaccines to minimise side-effects.
The Medical Journal of Australia reported last week that CSL was "one of only a few manufacturers globally" to use the ingredient.
The FDA audit also criticised CSL's "inadequate" investigation into the cause of dark particles that appeared in multi-dose vials of vaccines against swine and seasonal flu, produced for the US market in 2009.
"The investigation is ongoing and a root cause has not been determined," its report said.
It also noted that CSL had manufactured products "outside the validated processes" without determining if they would remain stable until their expiry date.
It cited a "formulation error" discovered in July last year, when not enough swine flu virus was used in the vaccine against seasonal flu.
The FDA inspectors raised the problem of black particles in multi-dose vials during an inspection of the Parkville laboratory in April last year.
The same discolouration had been detected in Australia's stockpile of swine flu vaccine, Panvax, for which the federal government paid CSL $131 million of taxpayer funds. Half the stockpile - 10 million doses - had to be destroyed after passing their use-by date last year, while the paediatric version was withdrawn early because the medication lost potency before the expiry date.
The FDA's 2010 audit found CSL's supplier of rubber stoppers had told the company they could react with the mercury in multi-dose vials and should not be used.
The TGA said it agreed with the FDA findings, but it refused to release its own audits.

UPDATE:  from the Australian Broadcasting Corporation

Health problems linger for survivors of the anthrax attacks/PA's Courier Times

The following article talks about an important finding, which I mentioned back in a 2002 NY Times interview:  the people who developed inhalation anthrax (or cutaneous anthrax that became generalized) were likely to suffer from the identical symptoms as those who became very ill after anthrax vaccinations.  These symptoms have now lingered for ten years in those who got the disease anthrax, and for ten years or more in those I have treated for anthrax vaccine exposures.  The symptoms are fatigue, impaired cognition, psychological problems and muscle/joint pains.  Perhaps not coincidentally, these symptoms also define Gulf War Syndrome.  Many of my patients have developed hormone deficiencies as well (both Gulf War and anthrax vaccine-injured patients) and it appears from the article that research physician Mary Wright at NIH is finding hormonal problems in her anthrax survivors as well.

How can you explain why people who got the vaccine have a similar chronic illness as those who caught the disease?  I don't believe any research has been published on this interesting fact, but it isn't hard to speculate.  This is particularly important for several reasons:  people who are cured of anthrax may never become well, unlike those who recover from most other infectious diseases.  What is fundamentally different about anthrax infection in this regard?  Furthermore, many monkeys who were given anthrax vaccine, then exposed to anthrax, actually got the disease but survived.  (See the July 18, 2000 Washington Post article by Tom Ricks, "Anthrax Shots' Effects Challenged:  Army Disputes Expert Who Reviewed Vaccine Tests.")

If people get the same level of protection afforded by the vaccine as the monkeys did, it may not prevent them developing chronic illness, although it may prevent their death. That doesn't speak well for the vaccine, and suggests a better vaccine is needed: both to be more effective at preventing anthrax, in addition to being more safe.

The licensed human anthrax vaccine, produced by Emergent BioSolutions, contains many anthrax proteins and other anthrax molecules produced during bacterial fermentation, and one or more of these probably cause[s] the symptoms, or cause[s] some type of deregulation that not only causes the symptoms, but allows them to persist, apparently forever.  The persistence of these symptoms--after the disease is long gone--is another issue crying out for study.

In the 10 years since 17 people survived the deadly anthrax attacks that terrorized the nation in the weeks following 9/11, little recent information is known about their health.
But the National Institute of Health has quietly monitored the health of seven of the those survivors, including Falls resident Patrick O’Donnell. The group represents the largest pool of anthrax survivors U.S. researchers have studied.
The ongoing study will provide the first comprehensive data on the long-term health effects of anthrax exposure, the project’s head researcher said recently.
“No one has ever documented followup in anthrax survivors,” said Dr. Mary Wright, the principal investigator with the NIH’s National Institute of Allergy and Infectious Disease.
Before 2001, the last reported U.S. anthrax case occurred in 1976, and it was reported two years later, according to the NIH. The only previous anthrax studies were 50 years old and contained little data about long-term effects or possible complications.
In fall 2001, 22 people in the U.S. were exposed to anthrax through tainted letters sent through the U.S. mail. Five died. Many of those affected were U.S. Postal Service workers, who either inhaled anthrax spores or were exposed to it through skin contact.
NIAD is the only research agency that is following the health of anthrax attack survivors, a project that started in February 2002.
The study participants include two with inhaled exposure, and all but one are regularly tested and evaluated every one to two years, Wright said. The testing includes neuropsychological, blood and hormone level tests. The study will continue as long as the participants are willing. And one survivor, a woman who has not recently participated, can return at any time, Wright said.
The most recently released information about the health of the survivors came in 2004. It was based on a one-year followup study of 15 of the 17 survivors conducted by the Centers for Disease Control and Prevention. That study used medical interviews, standardized self-administered questionnaires, and a review of available medical records.
The study found that eight of the participants hadn’t returned to work more than a year after the attacks, all were under psychiatric care, and most reported symptoms ranging from chronic cough, fatigue and memory problems to depression, anxiety and hostility. Eight survivors also reported moderate to severe joint problems and decreased physical functioning.
But diagnostic tests performed on six of the eight patients showed no signs of immune or inflammatory disorders or other common medical explanations for the symptoms.
Nearly nine years later, Wright says her data shows the survivors who were the sickest in 2001 continue to experience the most persistent symptoms, including memory trouble and chronic fatigue. These survivors either inhaled anthrax or had it enter their bloodstream after they contracted the skin form.
The sickest patients also have had the most difficulty returning to work. Though some have returned, they can’t perform at the same level as before, Wright said. Those with less severe symptoms appear to have returned to their regular lives.
Wright added that researchers know some survivors will develop common age-related medical problems, but there likely will be no way to prove a cause-effect relationship with the anthrax exposure.
“We are hoping what we learn, once we publish, is if there are new cases, including natural cases, that they can learn from this experience and monitor some of these variables, like hormone levels and memory testing and offer some support to folks,” Wright said.
O’Donnell, now 45 and a U.S. postal worker, was the 12th of the 22 anthrax attack victims. Four coworkers also were exposed and survived.
He returned to his job at the Hamilton, N.J., office in 2005, where he continued to work a “modified schedule” through Workers’ Compensation, according to a recent post on the PostalWorker News Blog, which isn’t affiliated with the U.S. Postal Service.
The Courier Times was unsuccessful in attempts to reach O’Donnell for comment.
O’Donnell came in contact with one of the tainted envelopes, a letter addressed to then Senate Majority Leader Thomas Daschle, while working overtime on Columbus Day 2001. Normally, he didn’t sort first-class mail.
Five days later, O’Donnell noticed a welt-like sore on his neck where he had nicked himself shaving the day he worked the overtime. He was treated at an emergency room for a suspected spider bite and released. The next morning, though, O’Donnell woke to find his neck had swelled to 27 inches around. The welt was now a pus-filled boil and a softball-size lump protruded from his chest.
He returned to the emergency room, where doctors confirmed he had an anthrax infection, triggering emergency infectious disease protocols. After five days in isolation with antibiotic treatments, O’Donnell was released.
O’Donnell last spoke to the newspaper in 2008, after he attended a private FBI briefing discussing Bruce Ivins, the late Army scientist the government said was responsible for the anthrax attacks. At the time, O’Donnell complained of symptoms that he believed were the lingering effects of the anthrax — stuffy head, achy joints, throbbing headaches, insomnia and panic attacks.
In an Aug. 6 post on the PostalWorker blog, O’Donnell wrote that he still suffers severe post traumatic stress disorder, which a doctor has diagnosed. He said his condition has been worsened because he continues to work at a postal center 300 yards from the building where he was exposed to anthrax and he’s required to sort and throw away waste mail.
He added that his repeated requests for a job transfer closer to home have gone nowhere.
“Without having been through this experience, it has been impossible for others, including U.S. Post officials, to comprehend the mental and physical toll I face each day driving back and forth to work and seeing the postal facility, a constant reminder of this terrible, near-fatal exposure I suffered,” O’Donnell’s post said. “This has proven to be no help whatsoever in me trying to obtain closure and getting on with my life. I just want to spend my last years of service at a facility with a less stressful, remindful environment.”
The USPS cannot comment on employee claims without the employee’s written permission, spokesman Ray Daiutolo said.
But Daiutolo said that if an injured worker disagrees with the offered position, that employee can provide supporting documentation to the Office of Workers’ Compensation Programs, which makes the final decision.
If an employee is returned to duty in a “suitable position” and subsequently experiences a worsening of his/her condition or has a change in work tolerances, that employee has the right to submit a claim for recurrence, Daiutolo added.

Probe on narcolepsy–H1N1 vaccine link finds genetic risk factor/ CIDRAP

Sep 1, 2011 (CIDRAP News) – A final report from Finnish health officials on the link between the 2009 H1N1 Pandemrix vaccine and narcolepsy confirmed the link, finding a greater risk than their earlier estimate and identifying a genetic risk factor in all patients.

In a statement on the findings today, a task force from Finland's National Institute for Health and Welfare also said an immunologic study found that one quarter of those who experienced narcolepsy after vaccination had antibodies that bound to the AS03 adjuvant component of the Pandemrix vaccine, which they said is a preliminary finding that requires more investigation.

Today's report put the increased risk of narcolepsy with vaccination at 6 cases per 100,000 people, which amounts to a 12.7-fold greater risk than in those who had not been vaccinated. The task force's first estimate in a January preliminary report was a nine times greater risk.

Some countries, mostly Nordic, have reported a link between the vaccine and narcolepsy in young people. Pandemrix, made by GlaxoSmithKline (GSK), is one of the 2009 H1N1 vaccines used in Europe during the pandemic.

In July the European Medicines Agency (EMA), in issuing its final review on the link, recommended a labeling change that limits the vaccine's use to protecting children and teens from the 2009 H1N1 virus when seasonal flu vaccine isn't available.

Finnish officials haven't found an increased risk in children younger than 4 or among adults older than 19.

In reporting the genetic findings in vaccinated patients who had narcolepsy, the task force said the risk factor for the condition is strongly linked to genetic factors that regulate immune responses. "Narcolepsy is considered an immune-mediated disease," they wrote.

Antibody tests found that less than 10% of those who had narcolepsy had been infected with the 2009 H1N1 virus, which led the group to conclude that infection with the strain doesn't appear play a significant role or show a combined effect with Pandemrix vaccination and narcolepsy onset.

The task force said so far Finland and Sweden are the only countries that have confirmed the link between Pandemrix and narcolepsy, though Norway and France have reported higher-than-expected numbers of cases. It added that several studies on the link are under way in countries that used considerable amounts of Pandemrix and Arepanrix, another GSK pandemic vaccine made in Canada that included the same adjuvant.

As of Aug 25, Finnish health officials had received reports of 98 narcolepsy cases in people who had been vaccinated with Pandemrix, and 79 were in patients between ages 4 and 19 years old. The condition was associated with cataplexy, a sudden and transient loss of muscle tone, in 78 cases.

Despite the limited number of unexpected and unfortunate narcolepsy cases, Finnish officials said the overall benefits of the vaccine still outweigh the risks.

They added that research teams in Finland and other countries are exploring the immunogenetics, pathogenesis, and clinical course of narcolepsy.

GSK spokeswoman Jennifer Armstrong told CIDRAP News that the Finnish data are similar to what officials reported earlier this year. She said Glaxo is committed to patient safety and is working closely with the EMA and other regulatory groups.

"Further information from ongoing studies is still needed in order to gain additional insight into the cause of the reported cases of narcolepsy," Armstrong said. "In addition, GSK has committed to conduct further research into any potential association between Pandemrix and narcolepsy and will seek independent expert advice on this research activity, as agreed with the EMA."

Doctors unleash legal challenge over inquest Dr David Kelly never had/ Mail Online

From Miles Goslett at the Daily Mail:

Doctors are preparing to challenge the Government’s decision not to hold an inquest into the death of Dr David Kelly...

This month the doctors were given a 33-page legal opinion by Aidan O’Neill QC, a colleague of Cherie Blair at Matrix chambers in London, indicating that Mr Grieve’s decision could be judicially reviewed, paving the way for an inquest. They are now set to proceed, managed by solicitors Withers LLP...

Speaking on behalf of the other three doctors involved in the case, Dr David Halpin said: ‘We need to raise about £50,000 to cover stage one legal fees to take this to the High Court but we believe this must be done. Britain has great potential for good but many people know it is now mired in mendacity. They must help the doctors get light into the dark corner of the Dr Kelly cover-up. Truth must out.’
The lawyers must be formally instructed by August 30 so that proceedings can begin by September 8, the legal deadline by which the judicial review must be under way...

The doctors’ decision is likely to cause significant unease within Whitehall.  No full explanation has been supplied for closing down the inquest into Dr Kelly’s death, which began as a matter of routine immediately after his body was found. It was replaced with a public inquiry chaired by Lord Hutton, who did not hear witness evidence under oath...

Last year it emerged that in 2004 all medical and scientific reports relating to his death – including photographs of his body – were secretly classified for 70 years.
Much of the material affected by this highly unusual gagging order has still not been released and no legal explanation for it has ever been made.
Mr Halpin added: ‘Coroners,  not politicians, should determine how, where and when someone has died. That is our law in our country. There is an element of David and Goliath here...’

The Imperial Presidency -- Why Is That a Secret?/ NY Times Editorial

From the NY Times Editor:

A former top official in charge of ensuring that real secrets are kept secret has delivered a stunning repudiation of the Obama administration’s decision to use the Espionage Act against a whistle-blower attempting to expose government waste and abuse.

J. William Leonard, who directed the Information Security Oversight Office during the George W. Bush administration, filed a formal complaint about the prosecution with the Justice Department and the National Security Agency, and urged punishment of officials who needlessly classify documents that contain no actual secrets.

In the case in question, Thomas Drake, an N.S.A. employee, faced 35 years in prison for espionage after he leaked information to a reporter about a potential billion-dollar computer boondoggle. The case collapsed last month with Mr. Drake walking away after a token misdemeanor plea to providing information to an unauthorized person. The government was deservedly berated by Judge Richard Bennett of Federal District Court in Maryland for an “unconscionable” pursuit of the accused across “four years of hell.”

Prosecutors dropped the felony charges at the 11th hour after Judge Bennett ordered them to show allegedly classified material to the jury. But Mr. Leonard said he was willing to testify for Mr. Drake that there were no secrets at issue and that he had never seen “a more deliberate and willful example of government officials improperly classifying a document.”

The Obama administration has misguidedly used the Espionage Act in five such cases of news media disclosures; previously there were no more than four in all of White House history. This comes as officials classified nearly 77 million documents last year — a one-year jump of 40 percent. The government claim that this was because of improved reporting is not reassuring.

Two years ago, President Obama ordered all agencies to review secret material by June 2012 with a goal of promoting more declassification. Unfortunately, the administration’s emphasis since then has all been in the opposite direction. Treating potentially embarrassing information as a state secret is the antithesis of healthy government.

Certain Hip Replacement Failures Zoom, but Getting the Data Nearly Impossible/ NY Times

The following excerpts from today's NY Times article point to serious failures of data collection, analysis, and commitment to safety at FDA.  The failures follow lax, politically-driven regulations, which allow products to be licensed without data if they are substantially like other licensed products.  There is no good guideline for how alike the products must be.   The continuing failure of FDA's information technology system only magnifies the problem. 

FDA administrators have overruled FDA scientists and FDA advisory committees to approve questionable medical devices and drugs.   FDA's infrastructure for reviewing the effectiveness and safety of devices and drugs after licensure is bare bones.  Therefore, once approved, it is very hard to take a product off the market.  The excerpts below are telling:

...One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints reviewed by The Times.

A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency’s overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries. 
 
“They are grasping at how they are going to get this information,” said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente...

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants. 

Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

“There is not an existing infrastructure for studying this kind of information,” Dr. Maisel said...

Meanwhile, researchers say it may be a year before standard protocols are formulated that may be central to the future studies, like a uniform procedure to measure metallic ions in a patient’s blood or how to calibrate diagnostic equipment to best detect tissue damage.