Sunday, February 28, 2010

The FBI's Anthrax Case/ NYT

From the February 27 NY Times

... More problematic is the investigative work that led the F.B.I. to conclude
that only Dr. Ivins, among perhaps 100 scientists who had access to the same
flask, could have sent the letters.

The case has always been hobbled by a lack of direct evidence tying Dr. Ivins to the letters. No witnesses who saw him prepare the powdered anthrax or mail the letters. No anthrax spores in his house or car. No incriminating fingerprints, fibers or DNA. No confession to a colleague or in a suicide note, just opaque ramblings in e-mail that the F.B.I. interprets as evidence of guilt.

The agency’s 92-page report sets forth a
mass of circumstantial evidence that points to Dr. Ivins. He worked alone in the
laboratory at night and on weekends just before the mailings, outside his usual
pattern. He often made long drives to mail letters from distant post offices
using pseudonyms.

Although he was a vaccine expert, not a weapons expert, he apparently had the skill and equipment to produce the highly purified spores used in the letters. That conclusion in particular ought to be validated by independent analysis.

The cumulative weight of the evidence seems persuasive. But the F.B.I. has a troubling history of building a circumstantial case against suspects who are later exonerated. We are inclined to agree with Representative Rush Holt of New Jersey, who is calling for an independent assessment to validate the findings. Americans need to be sure that the real culprit or possible accomplices are not still at large, waiting to do damage again. And we need to head off conspiracy theories that are apt to be fostered if the only judgment available comes from an agency eager to clear its books.

Friday, February 26, 2010

VA to Reconsider Benefits for Ill Gulf War Vets/ WP

In a hearing today, Feb. 26, VA Secretary Shinseki said he would be reviewing disability claims for Gulf War-related illnesses to be sure they were handled correctly. How this will be done was not specified. New training for personnel re how to evaluate claims is needed. New training and guidelines for doctors treating ill veterans is needed as well. The Washington Post discusses the hearing: VA to reconsider benefits for ill Gulf War vets.

FYI, my own views on Gulf War illnesses were expressed in my written testimony to House and Senate VA Committees in 2007. (My oral testimonies to the Committees were necessarily brief and incomplete, so I won't post them here.)

Bill for more investigation of '01 anthrax case passes House

From the Baltimore Sun:
A measure requiring further federal investigation into the 2001anthrax attack that killed five people was approved Thursday by the House of Representatives. It was proposed by two skeptics of a recently closed FBI probe that blamed the deadly attacks on Bruce Ivins, a microbiologist at the Army biodefense lab at Fort Detrick in Frederick. Maryland Republican Rep. Roscoe Bartlett, who represents Frederick, and Democratic Rep. Rush Holt, from the New Jersey district where the anthrax letters were mailed, want the director of National Intelligence to investigate potential foreign connections to the attacks. Ivins committed suicide in 2008 after coming under FBI scrutiny. "His colleagues say that he would not have done it," said Bartlett, who complained that Fort Detrick officials have refused to let him speak with scientists who work there. Holt said "many questions remain" about the FBI's handling of the case, including whether a foreign connection was "overlooked, ignored or not pursued."

- Paul West

Rep. Rush Holt speaking for his 2/25 anthrax investigation amendment

Thursday, February 25, 2010

US House Seeks Further Review Of Anthrax Attacks/AP

From WJZ and the Associated Press:
WASHINGTON (AP) ― The House of Representatives is seeking further review of the 2001 anthrax mailings that killed five people.
House members approved an amendment to an intelligence authorization bill Thursday that would require the government to look for credible evidence of foreign involvement in the attacks that killed five people and sickened 17 others.

The action comes six days after the FBI closed its investigation by concluding Army scientist Bruce Ivins was the sole perpetrator of the attacks.

The amendment was offered by New Jersey Democrat Rush Holt, from whose state the letters were mailed, and Maryland Republican Roscoe Bartlett. Maryland is home to Fort Detrick, the Army installation where Ivins worked before he killed himself in 2008.

Both congressmen have expressed doubts about the FBI's conclusions.

Wednesday, February 24, 2010

ACIP: Flu vaccine shot for everyone, every year/ LA Times

The LA Times reports that what I expected to occur has now happened. The CDC's ACIP used the swine flu pandemic to gin up flu anxiety and activity. They don't seem to care that Tamiflu was found to be an "Emperor's New Clothes" story, nor that the data to support vaccinating everyone (let alone the data to measure the risks) do not exist. ACIP prefers to forget that most Americans are perfectly healthy and are not at risk for severe flu complications. Nor that the theory about vaccinating school kids to protect their family members, especially granny, from flu is simply an unproven theory.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended Wednesday that all Americans over the age of 6 months -- with the exception of those who are allergic to eggs -- should receive a seasonal flu shot every year, beginning this fall...
The CDC has been slowly broadening the recommendations for flu shots over the last few years to the point where about 85% of the population is now covered. The primary exception now is adults ages 19 to 49 who do not have underlying medical conditions. But the committee noted that many such adults do not realize they are at risk because of diabetes, hypertension or other hidden problems and do not seek the shots...

Kissin Memo: Piecing Together the Anthrax Letters Story

The Frederick News-Post has posted a long memorandum by Attorney Barry Kissin, a resident of Frederick, Maryland on its website. Attorney Kissin has no professional connection to USAMRIID or Dr. Ivins. Yet he has followed the anthrax letters story closely, and has written a cogent and thoroughly documented though controversial paper discussing what various people said (and when they said it) about the anthrax letter spores.

There are so many important points that I will not attempt to select out just a few.

One major impression you are left with is that US government agencies--and no one else--control all the evidence in this case. The evidence has been described in different ways at different times, and by different spokespeople, who were often under cover of anonymity.

The public and media have had no direct access to the evidence: what we believe we know about this case is what has been doled out to us, little bits at a time. Much information has been withheld. Some has turned out to be disinformation: for example, the claim that the "chemical signature" of the water in which the spores were grown identified Frederick, Maryland, or the claim that the envelopes could be traced to the Frederick post office.

The evidence has been managed, such as during a meeting on the science held by FBI for science reporters in August 2008, when a person overseeing the FBI testimony (of Vashid Majidi) claimed to be a Naval employee, turned out to be on Battelle's payroll, and actually answers to God knows who.

The FBI's case is a sticky mess of facts, innuendo, and unsupported claims (some of which have faded away once their fiction was revealed, such as the "natural" occurrence of silicon within the spores). There is no solidity anywhere you press against this case.

Scott Shane has written in the NY Times that by many measures this has been the most complex and expensive case in the FBI's history. Yet the FBI's narrative plays fast and loose with the truth--in those few places the truth can be discerned. Hundreds of FBI agents are not part of a conspiracy. So what really happened to this investigation? How was it managed? Was it obstructed, how and by whom?

The taxpayers have bought a pig in a poke with this most expensive investigation, and it is time to inspect the goods.

FBI and Sandia were unable to produce an identical spore preparation: so how could they prove Ivins made the spores on Fort Detrick equipment??

Audio and Text from the National Academy of Engineering

Anthrax Close-up, Part 2


The FBI says spores from the anthrax attack letters are genetically linked to spores in a flask controlled by Fort Detrick researcher Bruce Ivins. But high-tech microscopic analysis shows what might be a key difference.


Randy Atkins: The chemical element silicon is in spores from the letters, but not in the flask. This means the spores used in the attack weren’t taken directly from the flask, but grown elsewhere…in the presence of silicon. But Serguei Popov, a George Mason biologist and former Soviet bioweapons researcher, says the levels of silicon are too high to be an accident – that it was either purposely added to weaponize the spores or…

Serguei Popov:...could have come from the use of foam suppressant agents, typically employed in the process of large scale fermentation of bacteria.

Randy Atkins: While the FBI thinks Ivins grew the spores at Fort Detrick, they haven’t been able to re-create them. Paul Kotula, an electron microscope expert at Sandia National Labs

Paul Kotula: We looked at over 200 samples in our lab that were various attempts to reverse-engineer the process under which these powders were made and did not find a match.

No reason to assume the anthrax powder was produced in the week before the letters were sent/ GSN

From Global Security Newswire, including material from the Frederick News-Post:

The fact that Ivins kept very late laboratory hours in the days before the letters were mailed is not as unusual as the FBI contends, said former USAMRIID head of bacteriology Gerry Andrews. Ivins was working on multiple projects at the time could have kept him at the laboratory late, he argued.
"The FBI, I think, is trying to give folks the wrong impression of the time line," according to Andrews.
Critics contend that the FBI was wrong to assume that the anthrax spores could only have been produced shortly before they were mailed. They actually could date back to 1997, Adamovicz said.
"There is an assumption by the FBI that the spores could have only been prepared in the week before each mailing. This is a fatal error in logic," he stated. "The only reason that I can derive why the FBI has proposed this is that it is the only period that helps provide circumstantial evidence against Bruce..."

The motive imputed to Ivins--that his research program was about to be shut down--is entirely incorrect. It may be the result of FBI conflating massive problems with the military's anthrax vaccine immunization program, which used Bioport's (Michigan-produced) anthrax vaccine, and was about to be shut down in August 2001, with Ivins' anthrax vaccine research program at Fort Detrick, Maryland.

Andrews also disputed the FBI assertion that Ivins wanted to create a massive public scare in order to secure more public funding for his anthrax vaccine research which was in danger of coming to an end. Rather, Ivins' work was funded until the end of 2005, he said (Eckstein, Frederick News-Post).

Additional details emerge to challenge the FBI's anthrax letter scenario

Today's NY Times carries an article by Richard Bernstein, "Haste Leaves Anthrax Case Unconcluded." Edited only slightly for brevity, the article follows:

... an article in Aerosol Science and Technology published in March 2008 has acquired considerable significance in light of the announcement by the F.B.I. last week that it would close its nine-year investigation of the 2001 anthrax attacks in the United States.

Aerosol Science and Technology reported on an attempt by a group of scientists at the Dugway Proving Ground in Utah to reproduce the dry, powderized substance that was found in one of the anthrax-laden envelopes mailed by the perpetrator of the attacks, in which 5 people were killed, 17 were sickened and the country, reeling from the Sept. 11 attacks of just a few weeks before, was sent into high alert.

The title of the paper, “Development of an Aerosol System for Uniformly Depositing Bacillus Anthrax Spore Particles on Surfaces,” demonstrated that to create anthrax in a dry aerosol form of the sort that can be dispersed through the air is a long and difficult process involving a lot of highly specialized machinery.

The original culture has to be incubated; spore pellets are then collected with a centrifuge; those spores are dried “by a proprietary azeotropic method,” before an “amorphous silica-based flow enhancer” is added to turn the otherwise sticky anthrax spores into an aerosol, after which the material has to be passed through a series of ever finer mesh screens that are activated by a pneumatic vibrator.

The point, as one scientist specializing in fine particle chemistry told me, blows a large hole through the 92-page summary of the investigation released last week by the F.B.I. and the Justice Department, the main conclusion of which is that Bruce E. Ivins, a scientist at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, in Maryland, was the anthrax mailer.

“Note that the proprietary azeotropic drying technique and the pneumatic mill are both superspecialized pieces of equipment, neither of which is at Detrick,” the specialist in fine particles, Stuart Jacobsen, said in an e-mail message.

But the F.B.I.’s entire case against Mr. Ivins is that he was able to manufacture the anthrax used in the attacks at his Fort Detrick lab, working late at night on the days before the actual anthrax mailings so nobody would see what he was doing.

At first, reading the F.B.I. report is to be swept up in the conclusion that the perpetrator of the deadly anthrax attacks was indeed Mr. Ivins.

Several hundred other scientists over the years have had access to the material in that particular flask, but according to the F.B.I., all of them except for Mr. Ivins were exonerated. Mr. Ivins committed suicide two years ago just as prosecutors were moving to indict him — an act that seems, under the circumstances, to be highly incriminating.

And yet, when you look a bit closer at the F.B.I.’s report, doubts persist, and they lend a good deal of credibility to the arguments of those, including some of Mr. Ivins’s former colleagues, that the F.B.I.’s case, as Representative Rush D. Holt of New Jersey put it last week, is “barely circumstantial.”

The report, for example, makes much of the fact that Mr. Ivins worked late at night in his lab in the days prior to the mailing of the anthrax, something he had not usually done, and that he had no alibi for what the F.B.I. report calls the “mailing windows,” the stretches of time when the perpetrator of the attacks deposited the anthrax-laden envelopes into a post office box in Princeton, New Jersey, a three-hour drive from Mr. Ivins’s lab.

That information seems very damning at first glance, but according to Jeffrey Adamovicz, Mr. Ivins’s supervisor at Usamriid, as the Fort Detrick facility is known, the F.B.I.’s claim that Mr. Ivins rarely worked at night — and only did so in the days before the anthrax was mailed — is simply untrue.

“Although I cannot directly dispute the hours the F.B.I. has shown for access to B3/4” — Mr. Ivins’s anthrax lab — “Bruce was well known for working late and early,” Mr. Adamovicz said in an e-mail message this week. “He may not have been in B3/4 but instead in his office or the BSL-2 labs. I think a broader examination of his access to all areas of the lab would confirm this.”

Beyond that, Mr. Adamovicz said, “the F.B.I. seems to be locked into the concept that the spores had to be prepared in the week before each of the mailings.”

“I’m unclear as to why they believe this other than that period matches to hours that Bruce was in suite B3/4 at night,” he said. “These spore preps could have been made anytime between 1997 and 2001, in my estimation.”

But most important is the failure of the F.B.I. to demonstrate that the anthrax used in the attack was actually produced in Mr. Ivins’s lab at Fort Detrick, or even that it could have been produced there. In a recent opinion article in The Wall Street Journal that poked holes in the F.B.I.’s case, an investigative reporter, Edward Jay Epstein, cites a letter written by the F.B.I. director, Robert S. Mueller III, in which Mr. Mueller says that the mailed anthrax contained 1.4 percent silicon — without which the anthrax would be a clumpy, sticky mess, according to Dr. Jacobsen, the fine-particles specialist.

Mr. Adamovicz said in his e-mail message: “This is very strong evidence that a process more sophisticated than Bruce Ivins or Usamriid possessed was used in making the spore preparations. I and others have calculated that it would take several weeks to months to grow the 5-10 grams of spores required for the letters using common lab protocols and laboratory capabilities present in Usamriid for growing spores.” He added, “The F.B.I. to date has provided no information on how this could be done.”

The point is not that Mr. Ivins wasn’t the anthrax mailer. Perhaps he was. But some of the F.B.I.’s arguments seem like conclusions in search of arguments, while other aspects of the report — notably its failure to deal with the silicon question — are conspicuously incomplete.

Saturday, February 20, 2010

Media Called for an Independent Investigation; New FBI report fails to assuage their concerns

Washington Post Editorial, September 19, 2008
"Anthrax Suspicions: Why an independent look at the FBI probe is essential"
THERE'S NO better proof of the need for an independent review of the FBI's anthrax investigation than the words of Sen. Patrick J. Leahy (D-Vt.)... Mr. Leahy rejected the agency's assertion that government scientist Bruce E. Ivins acted alone in creating and dispensing the deadly spores that killed five people and sickened 17 others.

"I believe there are others involved, either as accessories before or accessories after the fact," Mr. Leahy said. "I believe there are others who can be charged with murder." Mr. Leahy's skepticism was echoed by GOP Sens. Arlen Specter (Pa.) and Charles E. Grassley (Iowa)...

Even if the FBI got the science right, it still must explain how and why it eliminated from suspicion some 100 other people who had access to the vial... Serious missteps throughout the investigation -- including the original identification of a different Fort Detrick scientist as the FBI's top suspect -- demand that all of the bureau's work be examined by an independent commission or the Justice Department's inspector general.
As an editorial in the journal Nature observed ("Case not closed," August 21, 2008)
A group of independent experts needs to look hard at the F.B.I.’s technical analysis and detective work that combined to convince investigators that the mailed anthrax must have come from Dr. Bruce Ivins.

... Although this openness about the techniques is commendable, neither the conclusions drawn from the scientific analysis, nor such crucial legal elements as the veracity of the provenance and handling of samples, have been tested in court. So far only one side of the story has been heard: that of the prosecution...

The FBI should explain why it thinks the scientific evidence implicates Ivins himself, and not just the flask. As Kemp aptly puts it: "In this country, we prosecute people, not beakers."

... presumably the bureau would welcome a full congressional or independent enquiry into this case, as has been called for by Senator Chuck Grassley (Republican, Iowa) and several other lawmakers. It is essential that such an enquiry takes place.

A New York Times editorial ("Too little information," August 19, 2008) noted:
A group of independent experts needs to look hard at the F.B.I.’s technical analysis and detective work that combined to convince investigators that the mailed anthrax must have come from Dr. Bruce Ivins...

None of this circumstantial evidence has been subjected to close outside scrutiny. Congress should be sure to examine it closely. And given the overriding importance of the laboratory work in tracing the anthrax to Dr. Ivins’s batches, it is distressing that the F.B.I. has not released more details from its scientific investigation so that independent experts can evaluate it.

Now that Dr. Ivins’s suicide has precluded a court trial, there needs to be an independent evaluation of whether the F.B.I. has found the right man. For that, the ever-secretive agency is going to have to share more information.

Friday, February 19, 2010

Federal Bureau of Invention: CASE CLOSED (and Ivins did it)

But FBI's report, documents and accompanying information (only pertaining to Ivins, not to the rest of the investigation) were released on Friday afternoon... which means the FBI anticipated doubt and ridicule. And the National Academies of Science (NAS) is several months away from issuing its $879,550 report on the microbial forensics, suggesting a) asking NAS to investigate the FBI's science was just a charade to placate Congress, and/or b) NAS' investigation might be uncovering things the FBI would prefer to bury, so FBI decided to preempt the NAS panel's report.

Here are today's reports from the Justice Department, AP, Washington Post and NY Times. The WaPo article ends,

The FBI's handling of the investigation has been criticized by Ivins's colleagues and by independent analysts who have pointed out multiple gaps, including a lack of hair, fiber other physical evidence directly linking Ivins to the anthrax letters. But despite long delays and false leads, Justice officials Friday expressed satisfaction with the outcome.

The evidence "established that Dr. Ivins, alone, mailed the anthrax letters," the Justice summary stated.

Actually, the 96 page FBI report is predicated on the assumption that the anthrax letters attack was carried out by a "lone nut." The FBI report fails to entertain the possibility that the letters attack could have involved more than one actor. The FBI admits that about 400 people may have had access to Ivins' RMR-1029 anthrax preparation, but asserts all were "ruled out" as lone perpetrators. FBI never tried to rule any out as part of a conspiracy, however.

That is only the first of many holes in FBI's case. Here is a sampling of some more.

  1. The report assumes Ivins manufactured, purified and dried the spore prep in the anthrax hot room at US Army Medical Research Institute of Infectious Diseases (USAMRIID). His colleagues say the equipment available was insufficient to do so on the scale required.
  2. But even more important, the letter spores contained a Bacillus subtilis contaminant, and silicon to enhance dispersal. FBI has never found the Bacillus subtilis strain at USAMRIID, and it has never acknowledged finding silicon there, either. If the letters anthrax was made at USAMRIID, at least small amounts of both would be there.
  3. Drs. Perry Mikesell, Ayaad Assaad and Stephen Hatfill were 3 earlier suspects. All had circumstantial evidence linking them to the case. In Hatfill's case, especially, are hints he could have been "set up." Greendale, the return address on the letters, was a suburb of Harare, Zimbabwe where Hatfill attended medical school. Hatfill wrote an unpublished book about a biowarfare attack that bears some resemblance to the anthrax case. So the fact that abundant circumstantial evidence links Ivins to the case might be a reflection that he too was "set up" as a potential suspect, before the letters were sent.
  4. FBI fails to provide any discussion of why no autopsy was performed, nor why, with Ivins under 24/7 surveillance from the house next door, with even his garbage being combed through, the FBI failed to notice that he overdosed and went into a coma. Nor is there any discussion of why the FBI didn't immediately identify tylenol as the overdose substance, and notify the hospital, so that a well-known antidote for tylenol toxicity could be given (N-acetyl cysteine, or alternatively glutathione). These omissions support the suggestion that Ivins' suicide was a convenience for the FBI. It enabled them to conclude the anthrax case, in the absence of evidence that would satisfy the courts.
  5. The FBI's alleged motive is bogus. In 2001, Bioport's anthrax vaccine could not be (legally) relicensed due to potency failures, and its impending demise provided room for Ivins' newer anthrax vaccines to fill the gap. Ivins had nothing to do with developing Bioport's vaccine, although in addition to his duties working on newer vaccines, he was charged with assisting Bioport to get through licensure.
  6. FBI's report claims, "Those who worked for him knew that Nass was one of those topics to avoid discussing around Dr. Ivins" (page 41). The truth is we had friendly meetings at the Annapolis, Maryland international anthrax conference in June 2001, and several phone conversations after that. Bruce occasionally assisted me in my study of the safety and efficacy of Bioport's licensed anthrax vaccine, giving me advice and papers he and others had written. I wonder if I was mentioned negatively to discourage Ivins' other friends and associates from communicating with me, since they have been prohibited from speaking freely? Clever.
  7. The FBI's Summary states that "only a limited number of individuals ever had access to this specific spore preparation" and that the flask was under Ivins' sole and exclusive control. Yet the body of the report acknowledges hundreds of people who had access to the spores, and questions remain about the location of the spore prep during the period in question. FBI wordsmiths around this, claiming that no one at USAMRIID "legitimately" used spores from RMR1029 without the "authorization and knowledge" of Bruce Ivins. Of course, stealing spores to terrorize and kill is not a legitimate activity.
  8. FBI says that only a small number of labs had Ames anthrax, including only 3 foreign labs. Yet a quick Pub Med search of papers published between 1999 and 2004 revealed Ames anthrax was studied in at least Italy, France, the UK, Israel and South Korea as well as the US. By failing to identify all labs with access to Ames, the FBI managed to exclude potential domestic and foreign perpetrators.
  9. FBI claims that "drying anthrax is expressly forbidden by various treaties," therefore it would have to be performed clandestinely. Actually, the US government sponsored several programs that dried anthrax spores. Drying spores is not explicitly prohibited by the Biological Weapons Convention, though many would like it to be.
  10. The FBI report claims the anthrax letters envelopes were sold in Frederick, Md. Later it admits that millions of indistinguishable envelopes were made, with sales in Maryland and Virginia.
  11. FBI emphasizes Ivins' access to a photocopy machine, but fails to mention it was not the machine from which the notes that accompanied the spores were printed.
  12. FBI claims Ivins was able to make a spore prep of equivalent purity as the letter spores. However, Ivins had clumping in his spores, while the spores in the Daschle/Leahy letters had no clumps. Whether Ivins could make a pure dried prep is unknown, but there is no evidence he had ever done so.
  13. FBI asserts that Bioport and USAMRIID were nearly out of anthrax vaccine, to the point researchers might not have enough to vaccinate themselves. FBI further asserts this would end all anthrax research, derailing Ivins' career. In fact, USAMRIID has developed many dozens of vaccines (including those for anthrax) that were never licensed, but have been used by researchers to vaccinate themselves. There would be no vaccine shortage for researchers.
  14. Ivins certainly had mental problems. But that does not explain why the FBI accompanied Ivins' therapist, Ms. Duley (herself under charges for multiple DUIs) and assisted her to apply for a peace order against him. Nor does it explain why Duley then went into hiding, never to be heard from again.
  15. FBI obtained a voluntary collection of anthrax samples. Is that the way to conduct a multiple murder investigation: ask the scientists to supply you with the evidence to convict them? There is no report that spores were seized from anyone but Ivins, about 6 years after the attacks. This is a huge hole in the FBI's "scientific" methodology.
  16. FBI claims it investigated Bioport and others who had a financial motive for the letters attack, and ruled them out. However, FBI provides not a shred of evidence from such an investigation.
FBI gave this report its best shot. The report sounds good. It includes some new evidence. It certainly makes Ivins out to be a crazed, scary and pathetic figure. If you haven't followed this story intently, you may be convinced of his guilt.

On the other hand, there are reasons why a conspiracy makes better sense. If the FBI really had the goods, they would not be overreaching to pin the crime on a lone nut.

JFK, RFK, George Wallace, Martin Luther King, all felled by lone nuts. Even Ronald Reagan's would-be assassin was a lone nut. Now Bruce Ivins. The American public is supposed to believe that all these crimes required no assistance and no funds.

Does the FBI stand for the Federal Bureau of Invention?

Older information on this blog, germane to analysis of the FBI's case, includes the following:

Posts of mine that go into detail about these and other problems with the FBI's claims are here, here, here, here, here, here, here and here. Science magazine had additional questions. Vanity Fair published a fascinating article by Donald Foster that brings up more material the FBI ignored, here. Here I speculated on the emotional strain Bruce might have faced as a result of his knowledge of problems with the safety and effectiveness of currently used anthrax vaccines.

Sunday, February 14, 2010

England drowning in swine flu vaccine; Poland has none and explains why/ BBC

From Fergus Walsh, BBC Medical correspondent:
By my reckoning (and this is an estimate only) around 5.25 million people have been vaccinated in Britain. That means there is an awful lot of vaccine - tens of millions of doses - going spare. I'm told an announcement is likely in around 10 days regarding what will be done with the remaining stocks. As yet we don't have figures for how much the vaccine cost - due to commercial confidentiality...

One option being discussed with GSK, which was described as "innovative" by the Chief Medical Officer Sir Liam Donaldson, would involve keeping a stockpile of adjuvant, the booster chemical which is produced separately from the vaccine and mixed later.
Poland's Health Ministry spokesman, Piotr Olechno, said

"the government had decided not to buy the vaccines because it could not guarantee there were no side effects and it did not want to take responsibility for those.

"We don't think that the vaccine is dangerous but we cannot agree with the pharmaceutical companies not taking responsibility for the potential side effects," said Mr Olechno.

"The companies wanted the government to take responsibility for any potential side effects and that contravenes Polish law."

Saturday, February 13, 2010 advertises for Gardasil on its home page

Julie Gerberding moved to Merck Vaccines last month and CDC simultaneously decided to focus on cervical cancer. What a coincidence! The only cancer mentioned on CDC's home page is cervical cancer, and a chart of cervical cancer incidence by ethnicity is the only statistical information on the home page.

CDC says, "The PAP test and HPV vaccine can help prevent cervical cancer." Yet there is no data to show that adding the HPV vaccine to appropriate PAP screening will prevent any more cancers than PAP screening alone. HPV vaccinations may lead young women to omit screening, if they believe Merck's "one less" advertising slogan for Gardasil, its HPV vaccine. Then the vaccine could increase cervical cancer rates.

CDC is quick to say that uninsured children may still be able to get HPV vaccine through the Vaccines for Children program. Government not only advertises Merck's vaccine; it will even buy it for you!

The page fails to say anything, however, about potential adverse reactions to the vaccine, or about the remaining questions regarding efficacy and duration of effect, thought to be only about 5 years.

An excellent 2009 JAMA editorial on HPV vaccines notes,
"But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened.15 So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.

When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed."

The impact of cervical cancer needs to be put into perspective. More than ten times as many women die in the US yearly from breast cancer as from cervical cancer, and they are around the same young age as cervical cancer victims. More than fifteen times as many women die yearly from lung cancer as from cervical cancer.

CDC's list of the ten top cancers in women doesn't even include cervical cancer! Here it is:

View tabular data for Top 10 Cancer Sites: 2005, Female, United States
UPDATE: From the UK's Daily Mail, we find that Britain has gone a step farther. The government will not only buy your child the vaccine, it will pay her $71 in a shopping voucher when she completes all 3 doses. This National Health Service program is being piloted in Birmingham.
Teenage girls are being rewarded with shopping vouchers for having the cervical cancer jab.

Girls aged 16 to 18 are being given £45 of vouchers if they complete an inoculation course against the HPV virus, the sexually transmitted infection that causes 70 per cent of cervical tumours... No parental consent is needed...

A national campaign to vaccinate girls aged 12 to 18 has been criticised over fears it may encourage promiscuity and raise pregnancy rates, and uptake has been low among girls aged 16 to 18...

Another Attempt to Delay Release of David Kelly's Autopsy Records/ Daily Mail

In January, the Daily Mail revealed that Lord Hutton ordered David Kelly's post-mortem records to be barred from public access for 70 years. Hutton then responded that he would make the records available to physicians conducting a public inquiry on the death.

Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.

After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."

Large Mumps Outbreak Ongoing in Vaccinated Hasidic Jews

Snippets from Business Week. One solution being used in Orange County is to keep vaccinating with a third dose of the same vaccine, though the MMWR editor notes that no data exist to support this approach. Isn't the appropriate answer to develop a better vaccine?

According to the MMWR, "Among patients aged 7–18 years, the age group with the majority of cases and for whom 2 doses of MMR vaccine is recommended, 93% had received at least 1 dose, and 85% had received 2 doses."
A study released Thursday by the U.S. Centers for Disease Control and Prevention tracked an ongoing outbreak of mumps, largely confined to an orthodox Hasidic Jewish group. The outbreak started among boys attending a religious summer camp in New York State and continued when the youngsters returned to their homes in New York and New Jersey. Currently some 1,521 cases have been reported, with more individuals coming down with the disease.

"The outbreak has been ongoing since the end of June," said study co-author and CDC epidemiologist Kathleen Gallagher. "Ninety-seven percent of cases are among this Jewish community."

Most of the people who have become sick had received the mumps, measles and rubella vaccine (MMR), according to the report. In fact, 88 percent had received at least one dose of the vaccine and 75 percent had received two doses.

Outbreaks of mumps are not all that unusual, Gallagher said. "We have had outbreaks of mumps in communities that have had two doses before," she said.

Tuesday, February 9, 2010

CDC paid Harvard School Public Health for Multiple Polls of swine flu vaccine uptake, though it already knew the answer/ CDC

After paying for many polls of how many people got vaccinated, you can see that all were an unnecessary waste of taxpayer dollars by CDC, here--because CDC knew how many vaccines were given on a weekly basis:

The National Pandemic Influenza Plan calls for the Department of Health and Human Services (HHS) agencies, specifically the Centers for Disease Control and Prevention (CDC), to “assess vaccine coverage rates.” To meet this objective, Public Health Emergency Preparedness (PHEP) grantees are requested to track pandemic influenza vaccine doses administered and to report the associated aggregate counts to CDC. PHEP grantees (also referred to as Project Areas) include 50 states, 4 major metropolitan areas, and 8 U.S. territories. The CRA system has been enhanced to accept aggregate counts of pandemic influenza vaccine doses administered and to aid in reporting vaccine coverage rates on a state-by-state basis. Three options for submitting aggregate counts to the CDC using CRA have been developed:

OPTION 1: For Project Areas collecting data via an existing immunization information system (IIS), aggregate counts may be submitted via three standard data exchange formats.

OPTION 2: For Project Areas collecting data manually, data may be entered directly via the CRA aggregate reporting screen using a Web browser.

OPTION 3: For Project Areas using CDC’s CRA application to collect patient-level information, selected data elements will be automatically calculated and aggregated.
And here is an example of how the states require hospitals, clinics and other vaccination sites to report doses administered on a weekly basis.

Monday, February 8, 2010

Most Americans Think Swine Flu Pandemic Is Over, a Harvard Poll Finds / NY Times

Looks like the school-based swine flu vaccinations may have been a pilot program that CDC wants to become "routine." Excerpts from the NYTimes article:
Most Americans do not intend to get the swine flu vaccine, assume the pandemic is over and think the flu threat was overblown, according to a poll released Friday by the Harvard School of Public Health...

Dr. Anne Schuchat, the C.D.C.’s director of immunization and respiratory disease, who in early January urged all Americans to get shots because they had finally become plentiful, put a brave face on the low figures, saying she was “encouraged” because more children got shots than ever previously got regular flu shots and because many got them at school for the first time. If that became routine, it could lead to much wider flu protection because schoolchildren often are the vectors that infect their families... (a current hypothesis--Nass)

The Harvard polling data was of 1,419 adults, including 377 parents, and had a margin of error of three percentage points for the total response. It found that 21 percent of those polled had been vaccinated, and 15 percent intended to by the end of February. Of the parents, 40 percent had had their children vaccinated, and 13 percent intended to.

Lancet vs. Wakefield

I love the Lancet. I have my own subscription, and it isn't cheap. However, the Lancet took a cheap shot last week, when it retracted a paper on autism by Wakefield et al. immediately following a ruling by the UK's General Medical Counsel. The Lancet has been embroiled in controversy (and repeatedly tried to extract itself, but that's another story) since publishing the 1998 Wakefield et al. paper that put the issue of autism and measles vaccine on the map.

But the retraction didn't have to happen. The abstract discussed in the post just below this one shows that DHHS doctors came to a similar conclusion (that measles vaccine and neurologic damage in children should be investigated) the same year as Wakefield. Those authors were never put on trial, have retracted nothing, and Caserta is currently running the vaccine injury compensation program for swine flu vaccine.

Why is the Lancet retracting the paper now? The editors list two reasons: the children were not "consecutively referred" and the studies weren't approved by the local ethics committee. Well, after the many prior investigations of this paper, I am astonished that it took 12 years for Lancet to discover the lack of IRB approval. Sounds fishy.

Lancet is upset the children were not "consecutively referred"? Isn't that reaching a bit, editors?
Have you forgotten that JAMA recently published a paper claiming that 10% of your published papers are written by ghost authors? Maybe those papers should be retracted? Isn't faked authorship more important to root out than lack of consecutive referral, whatever that is supposed to mean?

Here is the Lancet statement:
The Lancet, Volume 375, Issue 9713, Page 445, 6 February 2010
Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.
And here are the major conclusions of the Wakefield paper that are being retracted, although their accuracy has not been disputed:
Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641.

We did not prove an association between measles,
mumps, and rubella vaccine and the syndrome described.
Virological studies are underway that may help to resolve
this issue.

If there is a causal link between measles, mumps, and
rubella vaccine and this syndrome, a rising incidence
might be anticipated after the introduction of this vaccine
in the UK in 1988. Published evidence is inadequate to
show whether there is a change in incidence or a link
with measles, mumps, and rubella vaccine. A genetic
predisposition to autistic-spectrum disorders is suggested
by over-representation in boys and a greater concordance
rate in monozygotic than in dizygotic twins...

We have identified a chronic enterocolitis in children
that may be related to neuropsychiatric dysfunction. In
most cases, onset of symptoms was after measles,
mumps, and rubella immunisation. Further investigations
are needed to examine this syndrome and its possible
relation to this vaccine.

Measles vaccine can cause encephalopathy 8-9 days post injection/ DHHS

I was hoping to avoid joining the Andrew Wakefield/Lancet fray, but so many inaccurate statements have been published in the last few days that I had to jump in. There is clearcut evidence for a syndrome of brain injury (and sometimes death) occurring after measles vaccine (and not after rubella or mumps vaccines). Who discovered it? DHHS physicians charged with responding to vaccine injury claims for the federal government. Here is the abstract, published in the journal Pediatrics in 1998.

I'd also like to point out that many children with autism have chronic diarrhea and other gastrointestinal problems, and there can be no question that these features are part of the autism syndrome. Some children are born with neurological impairment; some develop it later; but a surprising and statistically significant number developed it 8-9 days after getting their first measles vaccine, and no amount of hand-waving can erase this fact.

UPDATE: Here is the full text.

Pediatrics. 1998 Mar;101(3 Pt 1):383-7.

Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program.

Weibel RE, Caserta V, Benor DE, Evans G.

Division of Vaccine Injury Compensation, National Vaccine Injury Compensation Program, Health Resources and Services Administration, Public Health Service, Rockville, Maryland 20857, USA.

OBJECTIVE: To determine if there is evidence for a causal relationship between acute encephalopathy followed by permanent brain injury or death associated with the administration of further attenuated measles vaccines (Attenuvax or Lirugen, Hoechst Marion Roussel, Kansas City, MO), mumps vaccine (Mumpsvax, Merck and Co, Inc, West Point, PA), or rubella vaccines (Meruvax or Meruvax II, Merck and Co, Inc, West Point, PA), combined measles and rubella vaccine (M-R-Vax or M-R-Vax II, Merck and Co, Inc, West Point, PA), or combined measles, mumps, and rubella vaccine (M-M-R or M-M-R II, Merck and Co, Inc, West Point, PA), the lead author reviewed claims submitted to the National Vaccine Injury Compensation Program. METHODS: The medical records of children who met the inclusion criteria of receiving the first dose of these vaccines between 1970 and 1993 and who developed such an encephalopathy with no determined cause within 15 days were identified and analyzed. RESULTS: A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine.

CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.

Saturday, February 6, 2010

Hard sell: If you go to the doctor for anything the doctor will be offering free swine flu vaccine

From the UK's Daily Telegraph, excerpts from a story about Australia's new push to use up its swine flu stockpile. The multidose vaccine vials need to be used within 24 hours of opening.
DOCTORS have been told to issue the swine flu vaccine throughout summer in order to deplete the Government's stockpile before millions of doses expire.

Australia's chief medical officer Professor Jim Bishop will write to doctors this week urging them to "redouble efforts" to vaccinate as many patients as possible.

But critics say there is no legitimate medical reason to mass vaccinate against a flu that has proved to be far less serious than first feared.

The federal Government is committed to buying 21 million doses of the vaccine from [Australian] manufacturer CSL, but the take-up rate has been slower than hoped.

GPs admit they are doing opportunistic vaccinations to avoid wasting the vaccine, which comes in multi-dose vials that need to be thrown out after 24 hours. Patients who present with food poisoning or for a routine blood test are leaving with a swine flu jab...

Friday, February 5, 2010

Make Adult Vaccinations as Widespread as Those for Children, Say Immunization Advocates (Sponsored by Pharma)/ Medscape

A report claiming "dangerously low" adult levels of vaccinations just came out, sponsored by Trust for America's Health (TFAH), the Robert Wood Johnson Foundation and the Infectious Diseases Society of America (IDSA). TFAH focused on "emergency preparedness" and "pandemic preparedness" as the first two subjects covered in its last 2 annual reports (2005 and 2006) available on it website. Robert Wood Johnson Foundation was funded by pharmaceutical manufacturer Johnson and Johnson. IDSA was recently sued by Connecticut's Attorney general over conflicts of interest that may have affected the content of guidelines for Lyme Disease treatment issued by the Society.

The report is correct that immunization rates in seniors for influenza and pneumococcal vaccines are far below 100%. But since the evidence to support strong benefits resulting from these two vaccinations in seniors does not exist, logic would suggest this is neither "dangerous" nor too low.

This is simply another shot across the bow-- intended to push policymakers toward mandating more adult vaccinations. More later on the varied methods being used for this purpose.

Snippets from the Medscape article:
The United States needs a national strategy to immunize adults against infectious diseases that would achieve the same success found in childhood immunization efforts, according to a report released today that characterized adult immunization rates as dangerously low.

Between 40,000 and 50,000 adults die each year from vaccine-preventable illnesses, according to the report, published by the Infectious Diseases Society of America, the Robert Wood Johnson Foundation, and the Trust for America's Health.

The report, titled "Adult Immunization: Shots to Save Lives," states that one third of adults aged 65 years and older have not been vaccinated against pneumonia, and 30.5% have not been vaccinated against the seasonal influenza.

Trust for America's Health Executive Director Jeffrey Levi, PhD, said that the 3 report sponsors wanted to capitalize on the visibility and momentum of recent efforts to immunize people against the H1N1 influenza virus.

In contrast to the adult world, efforts to vaccinate children against various diseases have been far more successful, in large measure because state laws require immunization as a condition of attending school or day care, the report stated. No such institutional mandate exists for adults, apart from those in the military or certain colleges...

And from McClatchy comes another talking point for mandating vaccinations: Failure to use the vaccines adds about $10 billion annually to the cost of heath care, according to the U.S. Centers for Disease Control and Prevention...

Only 36.1 percent of adults have been vaccinated annually for seasonal flu.

"It sort of plateaued at that level," Glen Nowack, a spokesman for the CDC, said of the seasonal flu shots. "The next groups are not as easily persuadable. They have not been in the habit of getting the influenza vaccine. They have concerns about it, or don't believe it's going to be as effective. We've been working real hard to try and persuade them."

WHO challenged at public hearing on the handling of the Swine Flu pandemic/ Council of Europe

From the Council of Europe's website:

"Are decisions on pandemics taken on the best scientific evidence only?" was the question asked today at a public hearing of PACE's Committee on Social, Health and Family Affairs into the handling of the H1N1 pandemic. The World Health Organisation's flu chief defended his organisation, saying its advice was not improperly influenced by the pharmaceutical industry. Paul Flynn (United Kingdom, SOC) will now prepare a report on this topic, for possible debate by the plenary Assembly in July or October 2010.

Extracts of statements by main speakers
Statement by Dr Wolfgang Wodarg (PDF)
Statement by Dr Keiji Fukuda, World Health Organisation (PDF)
Statement by Dr Luc Hessel, European Vaccine Manufacturers (PDF)
Statement by Prof. Dr. Ulrich Keil
Biographies of participants (PDF)
Video of the hearing
Video of the press conference
Motion by Mr Wodarg and others (PDF)
Announcement of hearing

Tuesday, February 2, 2010

Holy moly, it's hard getting swine flu vaccine to people who might need it overseas/ NY Times

WHO's Dr. Fukuda still isn't making sense, only now he is discussing WHO's work getting vaccine to poor nations. Swine flu cases began falling rapidly in the US in October. Countries have been trying to give away much of their vaccine stockpile since December. Yet WHO has only managed to get vaccine to two countries. Guess they don't think it's that critical.

From Donald McNeil at the NY Times:
There is now so much unused swine flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses. But the world’s poorest countries — a few still facing the brunt of the pandemic — are receiving very little of it.

...countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the W.H.O. as a clearinghouse.

That transfer “turns out to be an incredibly difficult logistical action,” said Dr. Keiji Fukuda, the W.H.O.’s chief of pandemic influenza. “It’s a mammoth effort by an awful lot of people and organizations and countries but holy moly, it’s a very complex operation.”

Each country must submit a plan proving it can store refrigerated vaccine, give it to those who need it most, inject it safely and do medical follow-up. It must also sign letters exempting donors from legal liability, and the W.H.O. has to certify the vaccine as safe if the country has no regulatory agency. Even shipping adds delays. By December, Dr. Fukuda said, only five countries had even received syringes...

Monday, February 1, 2010

Vaccination Coercion: We don't have the data to show it's valuable, but some would force vaccinations nonetheless

Here's a big yawn from the Infectious Disease News: Mandatory policy increased influenza vaccine uptake among Health Care Workers.

The article claims that the program's "success" was supported by "consistent communication emphasizing patient safety and quality of care, coordinated campaigns, leadership support and medical director support to talk with any employee with concerns about the vaccine, on request.”

Hello? The "success" was not thought due to potentially losing your job? Even pregnancy was not an accepted contraindication to vaccination, unless a doctor gave you an exemption. And the Human Resources department, not physicians, was used to review exemption requests and act on them positively or negatively (by firing the employee). Fifty-one requests for exemptions were not granted. Since when does Human Resources come between employees and their medical care? I hope this process gets litigated.

Remember the poem by Martin Niemoller?
First they came for the communists, and I did not speak out—because I was not a communist;
Then they came for the trade unionists, and I did not speak out—because I was not a trade unionist;
Then they came for the Jews, and I did not speak out—because I was not a Jew;
Then they came for me—and there was no one left to speak out.
A human body that has not received its yearly flu booster and all other vaccines can be seen as an untapped revenue source. Remember: first they came for the schoolkids, then they came for the healthcare workers...