Proven Ways to Avoid Influenza Safely and Inexpensively

How well does flu vaccine work?

Two major reviews have come out in the past two months.  Michiels et al from the University of Antwerp found that the vaccine does prevent influenza among those aged 6-65, "however, there is strikingly limited good-quality evidence of the effectiveness of influenza vaccine on complications such as pneumonia, hospitalization and influenza-specific and overall mortality..."  as well as efficacy over 65.  It is less the flu than the complications and deaths from flu that we want to avoid... but these complications are precisely what no one has been able to show are improved by vaccination.  Vaccine 2011. Nov 15; (29) 49: 9159-70.

Michael Osterholm's group (U Minnesota) found effectiveness of standard (killed) flu vaccine for adults aged 18-59.  His authors used as gold standard the presence of influenza virus by PCR or culture.  No trials in adults over 65 or children below 18 met the strict criteria.  For live flu vaccine, efficacy was shown for 9 of 12 seasons in 10 trials, but only for children aged 6 months to 7 years.  

The group concluded, "Influenza vaccines can provide moderate protection against virologically confirmed influenza, but such protection is greatly reduced or absent in some seasons. Evidence for protection in adults aged 65 years or older is lacking.  New vaccines with improved clinical efficacy and effectiveness are needed to further reduce influenza-related morbidity and mortality."

What to do? 

Excerpted from:  A Home Toolkit for Primary Prevention of Influenza by Individuals and Families. Finkelstein et al. DISASTER MEDICINE AND PUBLIC HEALTH PREPAREDNESS 2011; 5: 266-271.  The authors of this review article are members of MIT’s Engineering Systems Division.  They suggest the following proven methods:

• Wash your hands thoroughly after leaving a sick person’s room. Scrub with soap and water or an alcohol-based hand sanitizer for 20 to 30 seconds.

• Wear a mask. At minimum, the mask prevents a healthy person from transferring a virus to his/her own nose and mouth—the highway to infection.

• Install air filters. High-efficiency particulate air (HEPA) filters can remove nearly 98 percent of virus particles; portable air purifiers and pointing a window fan out the window of the sickroom can also help.

• Control temperature and humidity. Higher temperatures and humidity levels can kill or disable viruses.

• Install an ultraviolet light. UV light is antimicrobial, and portable air purifiers with both UV lamps and HEPA filters can be purchased for $180 to $370.

Judge says no to inquest on weapons inspector Dr Kelly/ Mail

And the judge adds insult to injury by asking retired surgeon Halpin to pay Attorney General Grieve's legal costs.  The Mail provides the details:

A retired surgeon lost a major court battle yesterday in his campaign to secure a proper coroner's inquest into the death of weapons inspector Dr David Kelly.
Dr David Halpin was refused permission to challenge Attorney-General Dominic Grieve's refusal to hold an inquest into the Government scientist's mysterious death.
As the decision was announced at the High Court in London yesterday, there were cries from the public gallery of 'Shame' and 'This is not justice'.

A High Court judge refused a plea to open an inquest into the death of government weapons advisor Dr David Kelly

One woman shouted at the judge, Mr Justice Nicol, 'What about the fingerprint evidence?', a reference to the fact that no fingerprints were found on the knife Dr Kelly allegedly used to kill himself.
Dr Kelly was found dead in an Oxfordshire wood in July 2003 after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war.
His death was the subject of a public inquiry in 2003 chaired by Lord Hutton which found he committed suicide by slashing his wrist and swallowing painkillers.

He is believed to be the only person in modern times to have died in suspicious circumstances in this country whose final hours have never been fully examined by a coroner.
Reviewing the controversial case in June this year Attorney General Dominic Grieve said the evidence of suicide was 'overwhelming'.
But yesterday Dr Halpin, 71, a retired trauma surgeon, claimed Mr Grieve had acted 'unlawfully' and 'irrationally'.

An aerial view of Harrowdown Hill, Oxfordshire where Dr David Kelly's body was found

Dr Kelly allegedly slashed his wrist and swallowed painkillers after being named as the source of a BBC report accusing Tony Blair's government of lying to take Britain into the Iraq war

Hundreds of Daily Mail readers were among 830 members of the public who contributed around £40,000 to cover Mr Halpin's legal fees.
Rejecting Mr Halpin's application to seek judicial review, the judge told a packed courtroom yesterday it was the Attorney General's role to act as a 'filter' before matters got to court.
Mr Justice Nicol said: 'Parliament considered it necessary for such a filter. In my judgment he [the attorney general] has exercised that discretion and power lawfully.'
After the hearing Mr Halpin, from Newton Abbot, Devon, said: 'Nothing has changed as a result of today's decision.
'Dr Kelly has still not had an inquest, which makes him unique. I still think it is impossible to bleed to death by cutting an ulnar artery. I still don't understand why there must be so much secrecy around this case.
'This case was shackled by the law and the facts were obscured by that. The Hutton Inquiry had more holes in it than a Swiss cheese.'
Mr Justice Nicol ordered Mr Halpin to pay £5,568 towards the Attorney General's legal costs.

UPDATE:  Interview with Dr. Halpin.

Dr Halpin said he was going to 'take stock and reflect on what to do next' as a result of the decision.

Judge to hear campaigner's plea for inquest into Dr Kelly's controversial death/ Mail

From the Daily Mail:

A retired surgeon campaigning for a full coroner’s inquest into the death of Dr David Kelly will have his case heard by a High Court judge  on Monday (December 20).


David Halpin, 71, is seeking permission to challenge the Government’s decision in June not to order a coroner’s inquest into the controversial death...

Mr Halpin, a former trauma surgeon from Newton Abbot in Devon, said: ‘More than 800 members of the public worldwide, hundreds of them Daily Mail readers, have given about £40,000 to cover legal fees associated with this case. I am enormously grateful...

SIGA's sweetheart deal for smallpox drug questioned by Anderson Cooper/ CNN

This story, detailed by David Willman in the LA Times (and blogged by me 4 weeks ago) has now been re-reported (in great detail for television) by CNN.  It certainly deserves plenty of scrutiny, especially after SIGA's stock rose 32% yesterday, supposedly due to board member Fran Townsend's denying company interference with the contract.  DHHS (what a surprise!) even had the temerity to tell CNN that replacing the government's chief negotiator saved the taxpayer lots of money!

In case you forgot, the issues are these:

SIGA is selling the govt (for $433 million to 2.8 billion) a drug developed with government money to treat smallpox. No one knows if it works.  SIGA's controlling shareholder is Ron Perelman, a billionaire Democratic donor.  Contracting requirements were changed several times to ensure SIGA got the contract, and at a very high price.

Former administrations made sweetheart deals for 2 smallpox vaccines, for a total cost over a billion dollars, during the Clinton and Bush administrations.  There is enough vaccine for every American in a stockpile.  The vaccine works up to 4 days after an exposure.  There is no real need for a drug too.

The Obama administration, it appears, did not want to miss out on the opportunity (which generating fear of bioterrorism has provided) to spend huge amounts of taxpayer funds on useless products.  At least now a light is shining into the fetid swamp of bioterrorism procurements.  SIGA's is only one of many questionable deals.

UPDATE:  SIGA stock down 85% in 2011.

FDA disqualifies advisory committee member due to "intellectual conflict of interest"/ NJ.com

Sidney Wolfe, MD, is a well-known drug safety advocate and founder/ director of the organization Public Citizen's Health Research Group.  FDA finally blessed the quality of his work and reputation by inviting him to join its Drug Safety and Risk Management Advisory Committee in 2008.

But suddenly FDA has disqualified him from full voting membership at the committee meeting on the drug YAZ due to a claimed intellectual conflict of interest.  Let's look first at the basis of FDA's claim, and then look into what is generally considered a conflict of interest.

According to the Newark Star-Ledger, Public Citizen gave a "Worst Pills" rating to Yasmin, the predecessor to YAZ oral contraceptive, now the leading contraceptive pill by sales in the US:

The FDA said it disqualified Wolfe, the director of Public Citizen’s Health Research Group, from the meeting on the contraceptives for his "intellectual conflict of interest.’’
The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of "Do Not Use Pills’’ in 2002.
"He did not volunteer this information,’’ said agency spokeswoman Erica Jefferson. "It was brought to our attention.’’
The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.
Wolfe declined both options.
Advisory committee members, she said, are asked by the agency to disclose such information. "We do value Dr. Wolfe’s contributions,’’ Jefferson said, "but we are committed to preserving the integrity of the committee process.’’

 The Public Citizen website appears to give YAZ a balanced report.

What precisely is the meaning of "conflict of interest"?  According to the Columbia University course "Responsible Conduct of Research" syllabus:

There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a "wide range of behaviors and circumstances," they all involve the use of a person's authority for personal and/or financial gain.²

2.  Bradley SG. Managing Conflicting Interests, p. 136. In: Magrina FL, editor. Scientific Integrity: An Introductory Text with Cases. Washington, DC: American Society for Microbiology; 2000, pp. 131-157.


According to this definition, because Sid Wolfe did not stand to gain from either the presence of YAZ and Yasmine on a Public Citizen website, nor from his presence on the committee as a voting member,
he had no conflict of interest and therefore had no obligation to disclose to FDA what was on the Public Citizen website (or anything else).

FDA is plagued by many members of its advisory committees having financial conflicts of interest, which are not always disclosed.  Sometimes 50% of members have such conflicts, for which waivers are routinely granted.

Yet here comes physician Sid Wolfe, whose clear, career-long interest is in making the US pharmacopiea safer, and who may have preexisting knowledge about the drug in question.  Shouldn't FDA encourage members with more knowledge of a specific drug to participate in discussions about that drug?

Yet FDA finds this an intellectual conflict of interest.  I recall the CDC advisory committee that voted to expand the indications for anthrax vaccine.  None of them were experts on the vaccine... and this meant they were easily led by factual omissions and spin in the way information was presented to the committee by CDC staffers.  No one had the knowledge to detect the spin.

I just discovered that Ed Silverman at Pharmalot is blogging about this subject, so please go to his site for more information, including a pending inquiry to FDA.  Note also that Janet Woodcock of CDER is the person who pulled the plug on Wolfe in this case... and she is someone not known for her integrity in the relicensure of Lotronex.  Public Citizen also discusses Lotronex and Woodcock on its website.

Eliot Spitzer: A Secret Scandal/ Slate

Half the US GDP was loaned to banks with no collateral.  Recall that (former NY Attorney General and Governor) Eliot Spitzer was investigating the Wall Street banks at the time his indiscretions with call girls led to his resignation, ending any hopes of seeking the presidency.  Not only American, but many foreign banks were bailed out in the program Spitzer discusses.  An excerpt follows:

... During the deepest, darkest period of the financial cataclysm, the CEOs of major banks maintained in statements to the public, to the market at large, and to their own shareholders that the banks were in good financial shape, didn’t want to take TARP funds, and that the regulatory framework governing our banking system should not be altered. Trust us, they said. Yet, unknown to the public and the Congress, these same banks had been borrowing massive amounts from the government to remain afloat. The total numbers are staggering: $7.7 trillion of credit—one-half of the GDP of the entire nation. $460 billion was lent to J.P. Morgan, Bank of America, Citibank, Wells Fargo, Goldman Sachs, and Morgan Stanley alone—without anybody other than a few select officials at the Fed and the Treasury knowing. This was perhaps the single most massive allocation of capital from public to private hands in our history, and nobody was told. This was not TARP: This was secret Fed lending. And although it has since been repaid, it is clear why the banks didn’t want us to know about it: They didn’t want to admit the magnitude of their financial distress.

The banks’ claims of financial stability and solvency appear at a minimum to have been misleading—and may have been worse. Misleading statements and deception of this sort would ordinarily put a small-market player or borrower on the wrong end of a criminal investigation.
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So where are the inquiries into the false statements made by the bank CEOs? And where are the inquiries about the Fed and Treasury officials who stood by silently as bank representatives made claims that were false, misleading, or worse?

Only now, because of superb analysis done by Bloomberg reporters—who litigated against the Fed and the banks for years to get the information—are we getting a full picture of the Fed and Treasury lending. The reporters also calculated that recipient banks and other borrowers benefited by approximately $13 billion simply by taking advantage of the “spread” between their cost of capital in these almost interest-free loans and their ability to lend the capital.

In addition to the secrecy, what is appalling is that these loans were made with no strings attached, no conditions, and no negotiation to achieve any broader public purpose....

Fukushima nuclear catastrophe closer than thought/ The Australian

The Japanese government and TEPCO have released new information (based on simulations, however) on the extent of damage to the Fukushima nuclear reactors.  The Australian reports on the catastrophe:

MOLTEN nuclear fuel in one reactor at Japan's stricken Fukushima Daiichi plant burned through the steel pressure vessel and three-quarters of the surrounding concrete containment vessel that formed the reactor's last substantial internal barrier...

... In the case of the No 1 reactor, any fuel that escaped the secondary concrete vessel would have landed on a protective steel plate. Had it burned through that, it would then have confronted a 10m thick steel foundation beyond which lays ordinary soil.

The TEPCO and government analyses - which may not be the final word on the extent of the meltdown - showed that the fuel burned through a total of about 2m of the 2.6m thick secondary containment vessel.

The operator and the government agencies in charge of regulating the nuclear industry have consistently underestimated the severity of events at the plant...

More than 80,000 people have been forced out their homes as a result of the disaster, which ranks second only to the 1986 Chernobyl incident in terms of severity. Japan has also been forced to endure a run of food scares thanks to radioactive cesium deposited across wide areas around the plant.

The Japanese government has conceded that it may take 30 years to fully decommission the plant and that some areas around it may be uninhabitable for decades...

New Swine Flu Strain Keeps Health Officials on Alert/ ABC News

ABC News reports that a new strain of influenza has appeared in several states.  CDC officials are worrying that it might become the predominant strain this flu season.  Based on modelling, CDC thinks Tamiflu might help.  (However, Tamiflu only shortens bouts of flu by one day, according to the package insert.  It is probably a CDC favorite because it is better than nothing, which is the alternative.)

Does the new flu strain mean the seasonal flu vaccine won't work?  That seems to be the major concern, since no one has said it is killing its victims.

CDC scientists said they expected this years’ seasonal flu vaccine to provide adults with limited protection from the new flu virus, but that it wouldn’t help children.

What?  How can it work for adults but not for kids?  The "killed" child vaccine uses the identical antigens as the adult flu vaccine.  And the live child vaccine should also have those antigens, plus others.

Read between the lines:  adults (vaccinated or not) have had more exposures to influenza viruses than children, and it's an old exposure that will provide the immunity.  Adults who don't get vaccinated may even have better immunity than those who do, as the natural protection gained through exposure is more robust and long-lasting.  The elderly did not get sick from swine flu because an antigenically similar virus had come through many decades ago.  Immunity persisted.

But kids have had fewer seasons of influenza exposures, and therefore are less likely to be protected.

CDC wants you to get your shot, regardless.  So its spin docs are claiming "limited protection" for this year's shot. 

And after you get vaccinated, I have a flying pig to sell you.

Australian Medical Association urges watch on vaccines/ The Australian

This article is by Natasha Bita, who just won a Walkley journalism prize for her series on flu vaccine dangers in The Australian.

UPDATE:  The public's responses to her story "Virus in the System."  It is astounding that after the widely publicized problems with last year's childhood flu vaccine, the Health Minister (a lawyer) has the temerity to force 3 more vaccines on Australia's children--or have their parents forfeit $2100. 

Health Minister Nicola Roxon's 'Big Brother' approach has even the AMA squirming ... and pointing out that Australia's drug regulatory agency is entirely funded by pharmaceutical user fees, which equates with lax regulation:

DOCTORS demanded more monitoring of vaccine side-effects yesterday after the federal government announced penalties for families who fail to immunise their children.
Australian Medical Association president Steve Hambleton said the government must introduce "active surveillance" to monitor side effects instead of relying on doctors and patients to report problems through "passive surveillance".

Last year, health authorities took weeks to suspend a flu vaccine that caused febrile fits in children.

"For a vaccine, you are taking healthy people and trying to keep them healthy so surveillance of the side effects is doubly important," Dr Hambleton said.

"We need to maintain confidence in the program. We can't just say to people, 'Don't worry, it's safe'. "

Health Minister Nicola Roxon has added three vaccines -- meningococcal C, pneumococcal and chicken pox -- to the national immunisation program from July 2013. From July next year, families will miss out on $2100 in family tax benefit Part A payments unless they immunise their children with every vaccine on the government's list.

Dr Hambleton said doctors strongly supported immunisation to protect children against life-threatening illness.

But he called for taxpayer funding of Australia's medicines regulator, the Therapeutic Goods Administration, which is entirely funded by user-pays charges on the pharmaceutical industry.

He said the TGA needed to work "better and quicker" to ensure prescribing advice to doctors always included the most up-to-date data on clinical trials and side effects.

"We have to make sure regulators do their job," Dr Hambleton said.

"We do rely on the TGA for good quality, independent advice.

"Everything the TGA does is in the public interest so it should be publicly funded to do the extra work and notify the public of any changes that do come up. If it can't do what it needs to do, we need to ask why."

The Australian revealed yesterday that drug giant CSL had changed its prescribing information for next year's flu vaccine, to warn doctors that two toddlers had to be hospitalised during clinical trials of Fluvax in 2006.

The previous prescribing information for doctors had stated there were "no reports of adverse serious events". The TGA admitted that CSL had told it about the side effects in 2006.

Dr Hambleton said yesterday doctors might have blown the whistle on last year's Fluvax fits earlier had they been aware of the data that was left out of last year's prescribing information.

Unused German swine flu vaccine goes up in smoke (about 250 million Euros worth)/ The Local

... But the [2009 swine] flu was much milder than expected, and this, combined with safety fears over the new vaccine, led to only around seven percent of Germans opting to get the vaccine.

Germany actually purchased two different types of swine flu vaccine:  one with a novel adjuvant (that used less antigen and instead included a novel booster) and one without.  The one without the vaccine booster (a.k.a. novel adjuvant) was purchased for government officials and the military.  Not many ordinary Germans wanted the boosted, second class version that had been designated for them.  Other European countries generally purchased only one vaccine:  the one with the new adjuvant.  However, Poland bought neither, noting that the waiver of liability for vaccine injuries or vaccine failure demanded by the vaccine manufacturers was unacceptable.

The US government bought lots of novel adjuvant, but in the end chose not to use it in the swine flu vaccine.  Don't worry:  it remains in the stockpile, ready for the next dire (or not) threat.

US to pay $2.5M in photo editor's anthrax death/ AP

From the Associated Press, Maureen Stevens settles with the US government for her husband's death by anthrax, due to lax control of the material at government's Fort Detrick lab.

UPDATE:  From Scott Shane at the NY Times:

... A Justice Department spokesman, Charles S. Miller, said he could not comment on why the government was trying to preserve the secrecy of documents beyond what was already in the public court file. Court orders prohibit the disclosure of security measures at the Army lab and records of missing pathogens and other lapses.

For the Justice Department, simultaneously pursuing a criminal investigation and defending the Stevens civil suit has made for a tricky balancing act. By hunting for the anthrax mailer at Fort Detrick, F.B.I agents and prosecutors highlighted the very security problems the lawsuit was seeking to expose.

In a July filing in the civil case, Justice Department lawyers said Dr. Ivins “did not have the specialized equipment” in his lab to make the dry anthrax powder in the letters — appearing to contradict the department’s claims in the criminal case. Days later, the lawyers retracted the statement.

An Army spokesman, George B. Wright, said “significant progress” has been made in improving security at the biodefense lab, including continual evaluation of lab workers, tighter control of access to areas where pathogens are stored and continuous monitoring by closed-circuit television. [Interesting name of the spokesman, as George G. Wright, another army employee, was the original developer of the US anthrax vaccine.] 

What Really Happened to Strauss-Kahn?/ NY Review

More details emerge from this piece by Edward Jay Epstein about the Dominique Strauss-Kahn affair at the New York Sofitel hotel.  This does not wrap up the case, but provides additional information about the sequence of events and about the missing Blackberry, which DSK had arranged with his wife to be examined for a security breach upon his return to France... arranged two hours before the alleged sexual encounter took place.

Important Advantage from Actually Getting Flu?

Infectious Disease News has posted a report of a paper, "H1N1 pandemic less severe among adults with history of flu."  The paper suggests that people with preexisting antibodies to different H1N1 strains had more immunity to swine flu H1N1 than those without.  Getting a flu infection (whether or not you actually get sick... since the majority of people with influenza infections show few if any symptoms) leaves you with long-lived antibodies, and many more of them, than someone has who got vaccine.  And they protect against similar strains, which flu vaccine usually fails to do.

This might explain the data from Canada and Hong Kong (that I have blogged about several times) which showed that receiving flu vaccine in 2008 led to almost double the likelihood of getting sick from swine flu in 2009.  In other words, the unvaccinated from the previous flu season fended off swine flu much better than the previous season's vaccinated people did.

This means that catching the garden variety flu could protect you in future from the much-anticipated, threatening Pandemic Flu.  And the protection could be expected to last for many decades.  Vaccine protection only lasts months, or a year or two.  Maybe your body makes lemonade out of flu lemons.

UPDATE:  Apparently this article, in French, suggests the same thing: 

Geriatr Psychol Neuropsychiatr Vieil. 2011 Mar;9(1):11-9.

 

Adverse effects of the herd immunity or When childhood vaccination becomes deleterious for the epidemiology of infectious diseases in adults. 

Lang PO.

Département de réhabilitation et gériatrie, Hôpital des Trois-Chêne, Thônex-Genève, Suisse. pierre.o.lang@hcuge.ch

Abstract

The irremediable ageing of the world population, the aged-related increasing in the prevalence of infectious diseases the fear of any influenza pandemic rife have recently led the European Union Geriatric Medicine Society (EUGMS) et the International Association of Geriatric and Gerontology European Regions (IAGG-ER) of establishing vaccine recommendations dedicated to individuals aged of 60 years or above and promoting a life-course vaccination programme. This approach is mainly motivated by the herd immunity-associated effect on the epidemiology of infectious diseases observed within the adult and old adult population. This review (1) after a presentation of the concept and its demonstrated beneficial effects; (2) will detail that herd immunity acts with adverse effects on the epidemiology of the infectious diseases in the adult and aged individual population; (3) in order to demonstrate that maintaining a vaccine pressure in every age groups is imperative.

Future cancers from Fukushima plant may be hidden/ AP

As long as the research is methodologically sound and designed to capture a broad range of possible adverse outcomes from radiation released at Fukushima (where people have been exposed to many different isotopes through skin contact, inhalation and ingestion at widely varying doses), you will probably learn a lot about how the radiation affected health.  However, if you limit what you are looking for to only a few outcomes, such as childhood thyroid cancer, you will never identify the full range or number of adverse effects.  From today's article by the AP's Malcolm Ritter:

Even if the worst nuclear accident in 25 years leads to many people developing cancer, we may never find out.Looking back on those early days of radiation horror, that may sound implausible....

The idea that Fukushima-related cancers may go undetected gives no comfort to Edwin Lyman, a physicist and senior scientist with the Union of Concerned Scientists, a group that advocates for nuclear safety. He said that even if cancers don't turn up in population studies, that "doesn't mean the cancers aren't there, and it doesn't mean it doesn't matter."

"I think that a prediction of thousands of cancer deaths as a result of the radiation from Fukushima is not out of line," Lyman said. But he stressed that authorities can do a lot to limit the toll by reducing future exposure to the radiation. That could mean expensive decontamination projects, large areas of condemned land and people never returning home, he said. "There's some difficult choices ahead."

Japan's Cabinet this month endorsed a plan to cut contamination levels in half within the next two years. The government recently announced it plans to study the risk from long-term exposure to the low-dose radiation level used as a trigger for evacuations...

Eisuke Matsui, a lung cancer specialist and a former associate professor at Gifu University School of Medicine, criticized the project.  He said it appears to largely ignore potential radiation-induced health risks like diabetes, cataracts and heart problems that have been hinted at by some studies of Chernobyl.
"If thyroid cancer is virtually the only abnormality on which they are focusing, I must say there is a big question mark over the reliability of this survey," he said.
He also suggested sampling hair, clipped nails and fallen baby teeth to test for radioactive isotopes such as strontium that are undetectable by the survey's current approach.
"We should check as many potential problems as possible," Matsui said.
Yasumura acknowledges the main purpose of his study is "to relieve radiation fears." But Matsui says he has a problem with that.
"A health survey should be a start," Matsui says, "not a goal."  [In other words, if you already have the outcome in mind, your study is biased before it starts.--Nass]
Tatsuhiko Kodama, head of the Radioisotope Center at the University of Tokyo, urged quick action to determine the cancer risks.
He said big population surveys and analysis will take so long that it would make more sense to run a careful simulation of radiation exposures and do anything possible to reduce the risks.
"Our responsibility is to tell the people now what possible risks may be to their health," he said.

Dr. Joe Mercola's wide-ranging interview with me

Last month I went to Chicago to do a video interview with Dr. Joe Mercola on bioterrorism issues, anthrax, government responses and some of their ramifications (especially vaccines).  I thought he performed masterfully, asking the right questions and providing perspective.  The material he elicited builds a surprising story, which encapsulates most of my work over 23 years.  It is a long interview (77 minutes), but there are also bullet points, a synopsis and transcript, so readers can get as deep as they wish into the story.

Cost, need questioned in $433-million smallpox drug deal // aka Biodefense: Giving from the 99% to the 1% / LA Times

UPDATE:  Senator Claire McCaskill calls for DHHS IG to investigate the government's sole-source contract with Siga.

If you are unconvinced that government seeks ways to buy products from "insider" companies that tithe to those at the center of government, read David Willman's article in today's LA Times.  A few grams of anthrax, grown from stock at the USA's premier biodefense lab, kicked off quite the $69 billion dollar federal biodefense spending spree.  And it ain't over.

Actually, the spending spree started earlier, with Clinton, who bought millions of doses of smallpox vaccine for about $365 million.  The anthrax letters just ramped it up a few notches for Bush2.  Then-DHHS SecretaryTommy Thompson said it was going to cost a lot more than the $509 million he'd expected, to buy enough smallpox vaccine for every American.

The US had a 25 year old stockpile of old smallpox vaccine that not only had been tested and still worked, but was good at a 1:5 dilution. There were at least 15 million doses of old vaccine available, and perhaps a lot more.  The new vaccine was made using a virus from the old vaccine, so did not involve any major new technology.  It had the same serious side effect profile as the old vaccine.  One in 200 people getting smallpox vaccine for the first time developed heart inflammation.  Once the new vaccine was delivered, all stocks of the old vaccine were destroyed.

Soldiers are still receiving smallpox vaccine when they deploy overseas, despite the considerable risk and questionable benefit.

Obama has continued in the same vein with the purchase of an untested drug for smallpox (see below).  When the drugs and vaccines expire in a few years, the feds get to do it all over again. What a business model!

Why did government work so hard to make us afraid?  Cause we had few toys in the biodefense toy box, which meant government would be able to Buy, Buy, Buy (aka SPEND).  New products and new companies could be invented.  There were no rules for what we might need, nor how much.  This was an opportunity to create limitless sweetheart deals from the absolute bottom up. Mr. Willman gives us the dirt.  Dr. Nicole Lurie at DHHS is the Dems' enforcer for this contract, as well as for the pediatric anthrax trial. Excerpts below, but read the entire article here:

Over the last year, the Obama administration has aggressively pushed a $433-million plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work.

Senior officials have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world's richest men and a longtime Democratic Party donor...

Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the Food and Drug Administration on the virus. He called the plan to stockpile Siga's drug "a waste of time and a waste of money."

The Obama administration official who has overseen the buying of Siga's drug says she is trying to strengthen the nation's preparedness. Dr. Nicole Lurie, a presidential appointee who heads biodefense planning at Health and Human Services, cited a 2004 finding by the Bush administration that there was a "material threat" smallpox could be used as a biological weapon... [See the 2005 IOM report on the Smallpox Vaccine Program to confirm that the Bush administration never provided any evidence to support this claim, nor has the Obama administration.  Why is she hearkening back to Bush?  She needs some new talking points--Nass]

Negotiations over the price of the drug and Siga's profit margin were contentious. In an internal memo in March, Dr. Richard J. Hatchett, chief medical officer for HHS' biodefense preparedness unit, said Siga's projected profit at that point was 180%, which he called "outrageous."

In an email earlier the same day, a department colleague told Hatchett that no government contracting officer "would sign a 3 digit profit percentage." [But the DHHS official(s) who bought stocks of anthrax vaccine 3 times since 2008 did so as well, with a 300% markup--Nass]

In April, after Siga's chief executive, Dr. Eric A. Rose, complained in writing about the department's "approach to profit," Lurie assured him that the "most senior procurement official" would be taking over the negotiations.

"I trust this will be satisfactory to you," Lurie wrote Rose in a letter...

Lurie denied that she had spoken with or written to Rose regarding the contract, saying such contact would have been inappropriate. [Or is the accurate term illegal?--Nass]

But in a subsequent statement, an HHS spokeswoman acknowledged Lurie's letter to Rose, saying it "reflects the critical importance of the potential procurement to national security." 

... Two months after Project Bioshield was established, Siga purchased the rights to what became known as ST-246 and other assets from a Pennsylvania company, ViroPharma Inc., for $1 million in cash and 1 million shares of Siga's common stock. Over the next three years, the National Institute of Allergy and Infectious Diseases awarded Siga two research grants and a related contract, worth a total of $23.5 million, to develop the new drug.

From the outset, there was only one potential customer: the U.S. government.

For Siga, the stakes were high. ST-246 was its most promising experimental compound.

From 2005 through September, the company has paid three lobbying firms $800,000 to represent its interests in Washington, public records show. Disclosures filed by the lobbyists said they focused on Project BioShield and "issues related to homeland security and HHS," along with "government procurement of vaccines."

Siga representatives told The Times that the company had lobbied only "generally" for biodefense spending, adding: "Neither Siga nor anyone else on Siga's behalf ever lobbied anyone to get this contract."

Perelman and others at Siga's affiliate, MacAndrews & Forbes, have long been major political donors. They gave a total of $607,550 to federal campaigns for the 2008 and 2010 elections, according to records compiled by the Center for Responsive Politics. About 65% of that money went to Democrats. Perelman donated an additional $50,000 to President Obama's inauguration.

From December 2007 to January of this year, Rose, Siga's chief executive, served on the U.S. National Biodefense Science Board, which has advised Lurie on how to respond to biological terrorism and other potential health emergencies. (Rose was appointed during the Bush administration.)

... On Oct. 13, 2010, Siga announced that the government intended to award it a contract for ST-246 worth as much as $2.8 billion. Within days, Siga's stock price soared...

But the federal contract required that the winning bidder be a small business, with no more than 500 employees. Chimerix Inc., a North Carolina company that had competed for the contract, protested, saying Siga was too big.

Officials at the Small Business Administration investigated and quickly agreed, finding that Siga's affiliation with MacAndrews & Forbes disqualified it.

The Obama administration could have awarded the contract to Chimerix as the only eligible small-business applicant. Or it could have reopened the competition to companies of any size.

Instead, the administration moved to block all companies — except Siga — from bidding on a second offering of the contract.

In early December, officials completed a required "justification for other than full and open competition," which said an antiviral against smallpox was needed within five years and Siga was the only company able to meet that timetable.

The rationale was questioned by some in HHS, including contracting officer Brian K. Goodger, who in an internal email called it "a stretch..."

Siga and government officials soon began tangling over the price the company would be paid. Because the contract was no longer to be awarded based on competition and because the only customer was the government, officials sought to assess whether the company's proposed price was "fair and reasonable," as required by federal law.

In so doing, officials looked at how much government money had already gone into developing ST-246. Public records show $115 million in federal support, not including the stockpile contract.

After reviewing Siga's costs and the prices of other drugs produced in low volumes compared with commercial products, the HHS negotiators wanted to pay about $170 for each treatment. The company argued for more based on ST-246's potential value to the nation.

"Siga did not derive its price based on any cost information, and, from Siga's viewpoint, such information is not relevant to determination of an appropriate price," the company's chief financial officer, Daniel J. Luckshire, wrote to Lurie's office and others on March 4.

"Siga has created extremely valuable intellectual property, embodied in ST-246, and Siga has priced ST-246 based on the value of that intellectual property," Luckshire added...

Rose said "any further negotiation should occur with a more senior official [with] the authority to take into account the important policy issues that surround this procurement."

Two days later, Lurie wrote her conciliatory letter to Rose, pledging to install a new lead negotiator. Her top subordinate, Balady, followed through by naming Goodger to replace Early, who continued to work on the contract but not as lead negotiator.

A financial analyst for RBC Capital Markets reported to investors in May that the agreed-upon price per dose appeared to be $255. He arrived at that estimate by dividing the $433-million contract by the 1.7 million doses to be delivered. Siga told The Times that this would give a rough approximation of the per-treatment price.

On May 13, HHS announced what amounted to the second awarding of the contract, worth between $433 million and $2.8 billion, depending on whether the government exercised options to buy more of the drug in future years. Siga hailed it as a "historic event for the biodefense industry."

Throughout the negotiations over price and profit, a separate issue loomed: uncertainty over whether the Food and Drug Administration would approve ST-246 for use in humans.

For more than a year, the enthusiasm of HHS officials for stockpiling the drug has stood in contrast to the skepticism of the FDA. The agency's stance is important because the contract requires Siga to develop its drug "for ultimate approval by the FDA."

In a June 2010 email, Gary Disbrow, a virologist in HHS' biomedical unit, shared with colleagues his assessment of where the FDA stood on the smallpox drugs being developed by Siga and Chimerix, the North Carolina company: "My interpretation of their current position is that there is NO foreseeable path to licensure."

The problem was the inherent limits of animal testing in determining whether the drugs would be safe and effective in fighting smallpox in humans. Researchers are prohibited from infecting humans with the virus...

Lurie said she hoped the FDA would ultimately approve ST-246. "We would not have gone ahead with a procurement unless we thought there was a pathway," she said... [You couldn't make this stuff up--Nass]

The administration had intended to award Siga the exclusive option to replenish or expand the stockpile, but officials relented after Chimerix formally protested. In June, the government settled the dispute by dropping the exclusivity provision. That limited the value of Siga's contract to $433 million and meant that other companies could compete to fill future orders for the drug...  HHS officials were concerned about how Siga might react. Goodger reassured his higher-ups that despite its disappointment, the company would not seek "any negative publicity."

And if you still think the top pols in Washington play by the same rules as the rest of us, then read today's 60 Minutes story about how insider trading is legal--if you are a member of Congress.

Secret reports: With security spotty, many had access to anthrax /McClatchy

A McClatchy piece I thought was duplicative, but there is more meat than I realized at first glance:

... The existing security procedures _ described in two long-secret reports _ were so lax they would have allowed any researcher, aide or temporary worker to walk out of the Army bio-weapons lab at Fort Detrick, Md, with a few drops of anthrax _ starter germs that could grow the trillions of spores used to fill anthrax-laced letters sent to Congress and the media.
The two reports, which have not been made public for more than nine years, describe a haphazard system in which personnel lists included dozens of former employees, where new hires were allowed to work with deadly germs before background checks were done and where stocks of anthrax and other pathogens weren’t adequately controlled.

... Marked “for official use only,” the two reports were completed in 2002. One was conducted by a seven-member team from Sandia National Laboratories in Albuquerque, N.M. The other was by auditors for the Army’s inspector general’s office.

... The Sandia report emphasized that terrorists had obtained germs from research labs before. It cited a February 2001 National Defense University study that found 11 cases in which terrorists or other “non-state operatives” had acquired biological agents from “legitimate culture collections,” including three research or medical laboratories.

... The report said no rules governed movement of germ specimens from one building to another, for example, and that a test tube containing some of Ivins’ spores was left for weeks in a refrigerator in a second building.

 

... the examiners said, there was little way to detect diversions from flasks of germs, because a “malevolent” worker could grow more of the pathogen or find other ways to conceal the removal of a small amount....

Infamous Endorsement of Anthrax Vaccine for Children/ AHRP

The Alliance for Human Research Protection has written about the NBSB recommendations for testing anthrax vaccine in children:

... The NBSB recommendation was made despite its own report acknowledging that:

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”

Their justification is without substance, relying on a hypothetical, highly exaggerated risk from an unlikely event:

"Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.” 

What evidence exists of any "national and potentially global threat from anthrax"? 

... Knowledgeable critics believe this vote demonstrates the insidious influence federal biodefense funding exerts on academics and physicians who can be counted on to sanction even the most egregious, ill-conceived government initiative and lend credence to hypothetical, unsubstantiated risks.

FDA's latest label warnings (2008) states:

"Since the risk of anthrax infection in the general population is low, routine immunization is not recommended."
"Safety and effectiveness of BioThrax have not been established in pregnant women or nursing mothers, or in pediatric or geriatric populations"...

 

High Court judge will hear call for inquest on Dr David Kelly's death/ Daily Mail

From the Daily Mail's Miles Goslett:

The death of Dr David Kelly is to be examined at the High Court next month after a senior judge ordered a special hearing as part of  his review of the case.

Mr Justice Kenneth Parker is considering an application from retired West Country surgeon David Halpin to challenge the Government’s decision this summer not to hold a coroner’s inquest...

Public Citizen Goes on Record Opposing Unethical Anthrax Vaccine Trial in Children

From the Public Citizen advocacy organization, discussed by periodical The Hill:

November 1, 2011


The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

RE: Proposed Clinical Trials Testing the Anthrax Vaccine on Children

Dear Secretary Sebelius:

Public Citizen, representing more than 225,000 members and supporters nationwide, urges you to reject the National Biodefense Science Board’s (NBSB) recommendation to conduct pre-event clinical trials of the anthrax vaccine in children. Such trials would be unethical and are prohibited under the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations for the protection of human subjects.

The proposed research would be unethical, because the research does not present any prospect of direct benefit to the children who would be the subjects of the research, and the vaccine poses significant known risks of potentially serious harm. The most serious known risk of anthrax vaccine is anaphylactic shock. Other potential risks identified in either clinical tests or postmarketing surveillance include:1

 Serious allergic reactions, including angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction and Stevens-Johnson syndrome;

 Nervous system disorders, including headache, paresthesia, syncope, tremor, ulnar nerve neuropathy;

 Musculoskeletal, connective tissue, and bone disorders, including arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia;

 General disorders and administration site conditions, including injection site reactions (including pain, nodule, edema, induration, erythema, warmth, pruritus, cellulitis), fatigue, pyrexia, flu-like symptoms; and

 Multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system.

Furthermore, such research could only be supported by HHS if both you, in accordance with the requirements of HHS human subject protection regulations at 45 C.F.R. 46.407, and the commissioner of the FDA, in accordance with the requirements of FDA regulations at 21 C.F.R. 50.54, consult with a panel of experts in pertinent disciplines (for example, science, medicine, education, ethics, law) and, following an opportunity for public review and comment, determine that:

(a) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious health problem affecting the health or welfare of children;

(b) the research would be conducted in accordance with sound ethical principles; and

(c) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

Regarding determination (a), anthrax currently is not “a serious health problem affecting the health or welfare of children” in the U.S., and the extremely remote chance of children being exposed to anthrax is not sufficient justification for testing the anthrax vaccine in children, particularly since there are antibiotics approved by the FDA for use in children to treat post-exposure cutaneous or inhalation anthrax, including penicillin and doxycycline.

Regarding determination (b), as we have noted above, the proposed research would not be consistent with sound ethical principles, because exposing vulnerable children, who lack autonomy to make an independent decision about participation in research, to a high-risk experimental intervention is not justified given the lack of any direct benefit to the subjects and the fact that anthrax is not a serious health problem affecting the health and welfare of children.

Finally, regarding determination (c), it is highly unlikely that parents who are truly informed about the nature of the anthrax vaccine, the absence of benefits to the subjects, the availability of FDA-approved antibiotics for post-anthrax exposure treatment, and the highly unlikely possibility of anthrax exposure to children would give permission for their children to be in such research.

Millions of taxpayer dollars currently are being spent to maintain a national stockpile of anthrax vaccine. Exaggerating the risk of an anthrax bioterrorism event for both adults and children may help justify such expenditures, but should not be used to justify unethical research in children.

In closing, we urge you to immediately reject the NBSB’s recommendation to conduct unethical pre-event clinical trials of the anthrax vaccine in children.
Thank you for your prompt attention to this matter.

Sincerely,

Michael A. Carome, M.D.
Deputy Director
Public Citizen’s Health Research Group

Sidney M. Wolfe, M.D.
Director
Public Citizen’s Health Research Group

cc: Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response

1 Emergent BioDefense Operations Lansing Inc. Biothrax Label. Revised December 2008. Available at http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/UCM074923.pdf. Accessed October 31, 2011.