Charred shrink wrap in Merck vaccines/ WSJ

Extraneous materials in vaccines is an old story.  Many have been shown to contain unwanted viruses or even bacteria such as mycoplasma.  (I used to have the abstracts posted on my website showing examples.)  Anthrax vaccines had flecks of stopper material and fungi in them, noted on visual inspections by FDA in the late 1990s.  Today Merck's West Point, PA plant has been cited for problems.  From the WSJ blogs and WSJ:

When you make drugs or other medical products, unwanted contaminants can fall into the mix — say, beetle parts (in baby formula) or glass flakes (in anemia drugs).
The latest pharma world example of wow-that-really-shouldn’t-be-in-there comes from Merck. As the WSJ reports, the company says charred bits of plastic shrink wrap have been found in vials of vaccines made at a big plant in West Point, Pa.
Affected products include Gardasil, used against the human papillomavirus, as well as shots against shingles, measles/mumps rubella, pneumococcal disease and chicken pox.
How’d this happen? It seems pieces of the wrap weren’t removed during vial washing and were charred during a sterilization process. Merck says there are no reports of adverse health problems, though theoretically the particles could cause a reaction at the injection site. The problem is very rare, according to the company.
The FDA has been tracking problems at the plant since 2008, according to the WSJ. A series of inspection reports have chronicled the issues — most of which have been resolved, Merck says. Here they are:

An April 2011 report cited the shrink-wrap particles, saying there were a dozen company-submitted reports about the problem since November, 2009 — eight due to customer complaints. The report noted that while plastic boxes replaced shrink-wrapped vials in some cases, some product vials were still being shipped in the wrap, raising the possibility of further problems. (Merck tells the WSJ it will end the use of shrink wrap on incoming vials by the end of the year.)

A report from August, 2010, found that an undisclosed number of adverse event reports involving drugs made at the plant weren’t submitted to the FDA in a timely fashion — that is, within 15 days.

An inspection report from January and February of 2009 identified problems including stainless steel particles in certain vaccines and a treatment for black widow spider bites, and cracked vaccine vials.

Judge: You can't change anthrax filing yet. Government must "show good cause"/ McClatchy

From the Kansas City Star, a McClatchy paper, Frontline and ProPublica authors:

A federal judge has blocked, at least temporarily, a Justice Department attempt to back away from court admissions that appeared to undercut previous FBI assertions that an Army researcher was responsible for the 2001 anthrax attacks.

In an order issued Monday, U.S. District Judge Daniel Hurley of West Palm Beach, Fla., said the government must "show good cause" before he will allow it to change the original filing, which lawyers for the department's Civil Division made in an 8-year-old case brought by the family of one of the five victims.

That filing asserted that Bruce Ivins, who the FBI alleges manufactured the anthrax in his government lab, did not have access in the lab to the special equipment needed to make the deadly powder. The Justice Department wants to revise the filing to say that Ivins did have access to the equipment elsewhere at the U.S. Army bio-weapons facility in Frederick, Md., where he worked.

It's unclear whether the department's attempt to undo its filing in the civil suit will result in further disclosures about the FBI's theory of how Ivins could have prepared the anthrax powder contained in letters mailed to Florida, New York City and Washington. Ivins, who committed suicide in July 2008 after learning that prosecutors were pushing for his indictment on five capital murder counts, had been known to work with anthrax only in a wet solution...

UPDATE:  Judge Allows Feds to Revise Filing in Anthrax Case by same authors at ProPublica, Frontline and McClatchy.

... U.S. District Judge David Hurley of West Palm Beach, Fla., accepted a government attorney’s declaration that the FBI and federal prosecutors didn’t alert the government defense team to 10 errors in a statement of facts until after it had been filed in court on July 15.
The initial filing [1] asserted flatly that the U.S. bioweapons facility that employed researcher Bruce Ivins, whom the FBI accused of manufacturing the anthrax, did not have “specialized equipment” needed to produce the deadly powder in the secure biocontainment lab where Ivins had a workspace...

UPDATE Sept. 2, 2011: from the Kansas City Star:

Senator Grassley asks "the Justice Department to explain why its civil lawyers filed court papers questioning prosecutors' conclusions that an Army researcher mailed the anthrax-laced letters that killed five people in 2001.

In a letter this week to Attorney General Eric Holder and FBI Director Robert Mueller, Sen. Charles Grassley of Iowa said the department's decision to quickly retract the contradictory filings "has produced a new set of questions regarding this unsolved crime..."

In his letter, sent Wednesday, Grassley said the Justice Department's initial filing in the court case "seemingly eliminated" the government's circumstantial case against Ivins, who committed suicide in 2008 after learning that prosecutors planned to seek his indictment on five counts of capital murder.
Grassley said he found the department's contradictory filings "particularly troubling" because a National Academy of Sciences panel in February called into question the FBI's assertion that genetic sequencing had definitively traced the source of the anthrax powder to a flask in Ivins' lab. He noted that two USAMRIID scientists, in sworn depositions in the suit, disputed the FBI's conclusion that Ivins could have made the powder in his laboratory.
Grassley also asked for an update on a prolonged investigation into news leaks that publicly identified another former USAMRIID microbiologist as a subject of the FBI investigation.

Pro-HPV Vaccine Chutzpah/ Pharmalot

Thanks to Ed Silverman at Pharmalot for posting on this issue, and for his links.


I've blogged in the past here and here about how Merck created a complex scheme to market Gardasil vaccine through mandates from state legislatures.  It seemed this was not working, as only one state and the District of Columbia passed such mandates.  After Governor Rick Perry of Texas, whose former chief of staff was a Merck lobbyist, used an executive order to mandate HPV vaccine for children in Texas in 2007, the Texas legislature voted to rescind the mandate.


But now it gets worse.  A bill in the California legislature would take away parental rights to make the decision about HPV vaccine.  Twelve year olds could be offered the vaccine in school and decide for themselves whether to take it.  


The sleight of hand used to accomplish this was to call HPV infection a sexually transmitted disease (yes, it is an STD) and then treat the vaccine as if it were a medicine used to cure an STD.  Although California law already allows children 12 and older to consent to treatment for sexually transmitted diseases without involvement from their parents, the proposed bill would expand that right to immunizations.


This is a situation in which a group of California bishops has the same impression as I about this legislation, and they are speaking out:

“Most parents are involved in the lives of their minor children and need to know if they are seeking medical care, regardless of whether the care is curative or preventative. This bill appears to be an ‘end run’ following the failure in 2007 to mandate HPV vaccination for all girls entering public junior high school - a measure strongly opposed by parents’ rights groups and vetoed by the Governor.” 

Let's watch what happens to this bill.

European Medicines Agency confirms that Pandemrix vaccine caused narcolepsy/ EMA

According to the European Medicines Agency press release:

The Committee for Medicinal Products for Human Use (CHMP) considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results show an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The results indicate a six- to 13-fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). A similar risk has not been confirmed but cannot be ruled out in other countries.
The Committee noted that the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to the results. There are several initiatives being developed across the EU to further investigate this association....

All illnesses occur due to a complex mix of environmental exposures and genetic predisposition.  Had the adverse effect been Guillain-Barre Syndrome, for example, the same could be said.  In other words, the statement that the vaccine "is likely to have interacted with genetic or environmental factors which might raise the risk..." is a truism, which detracts from the seriousness of the vaccine adverse effect. 

Roughly 20% of the population has the HLA type that seems to be needed for narcolepsy,  Some people who have this HLA type get narcolepsy after vaccination, but most don't.  Therefore something else is needed to explain the onset of narcolepsy.

The bottom line is that vaccination increased narcolepsy cases by 6-13 times what would be expected without Pandemrix vaccination.  This is the same ballpark increase in incidence that the 1976 swine flu vaccine caused in Guillain Barre cases.

Since narcolepsy tends to have its onset around age 15 anyway, this was the age group in which most cases were found.  Although an increased risk was not found in the over 20 age group, this might simply be due to insufficient cases to make a statistical inference.

In any event, the vaccine is no longer recommended in the under-20 age group.

Next question:  is this serious adverse effect due to the novel ASO3 adjuvant that the vaccine contained, which had only been used in a small number of people previously?  This is the important question, and the one that has been dodged by EMEA and the press.  It is important because a number of new candidate vaccines not yet licensed include ASO3.  No other vaccines used for a mass audience contain ASO3.  [Cervarix HPV vaccine contains ASO4.]  Can our regulatory agencies please study the ASO3 issue before we use this product in human vaccines again?  Could FDA direct that it be studied in animal models?  Some dogs have a known genetic tendency toward narcolepsy and could serve as a good animal model.  They should be evaluated for their response to a) this adjuvant alone, b) to the H1N1 antigens alone, and c) to the Pandemrix vaccine.

"Oops! We hoped you wouldn't notice"/NYT, CIDRAP, Glenn Greenwald, Marcy Wheeler

After seriously undercutting the FBI claims about Bruce Ivins' guilt 5 days ago, the DOJ revised its filing yesterday in the case brought by Bob Stevens' wife against the government.

Marcy Wheeler provides great details and links to the filing and other useful documents.  Scott Shane gives us the usual FBI response when challenged:  “We are confident that we would have proven his guilt beyond a reasonable doubt at a criminal trial.”  CIDRAP notes:

The investigative reporters and other media outlets have suggested that the DOJ is likely poking holes in the case against Ivins as a strategy to defend the government in the civil suit, which claims negligence. For example, the Frederick (Md.) News Post reported yesterday that in a motion to dismiss the case, the DOJ argues that any doubt about Ivins' guilt would make it more difficult for the victim's family to show government negligence.

The ProPublica group said it's unclear how the DOJ's civil court filings came to be so at odds with the case put forward by its prosecutors, and that the DOJ has not offered an explanation.

Glenn Greenwald has written a polished synopsis of how the FBI case has been disputed, while also discussing the meaning of the DoJ filing.

IMHO, Friday's DOJ statement of facts followed the identical methods used by FBI during the past 3 years.  [Ivins died on July 29, 2008 and the FBI's (media) case was first prosecuted on Aug 1 by David Willman.]

The FBI's M.O. has three parts.  In Part 1, the FBI strings together a complex scenario that sounds plausible as long as one isn't knowledgeable about the details of the case.  This method is designed to confound 99% of reporters and 99.99% of the public, and does so successfully.  FBI avoids discussing those parts of the case that cannot be explained by the synthesized scenario, and there are many.

FBI felt it could kill the 2011 Stevens case by challenging its earlier scenario, assuming nobody would notice.  When they noticed, FBI simply repaired the brief.

Part 2 of the M.O. is an attempt to obtain testimonials from eminent authorities, and silence any authoritative voices that might challenge FBI's case.  The National Academy of Sciences study was purchased to shut up the Judiciary Committees of Congress, and when NAS' report was not going well for the FBI, FBI showed up with a new document dump, designed to scare the NAS committee members about the seriousness of the bioterrorism threat, and thereby coerce them to go easy on the FBI.

When that didn't work, and the report undercut FBI's claims about the genetics studies conclusively linking Ivins to the letters, FBI tried to preempt the NAS report by loudly "closing the case" several months before the report was released (after an FBI review that forced its release to be delayed).

At Fort Detrick, everyone still employed was forbidden to discuss the matter.

Part 3 of FBI's M.O. is to proclaim (at every possible juncture) FBI's total conviction that the case against Ivins would prove his guilt in court.  This is based on the premise that if you say it enough times, loud enough, for long enough, practically everyone will come to think it is true.

This time the FBI M.O. will fail, because people are paying close attention, since the anthrax letters are so important to understanding recent American history.  As Greenwald puts it:

... discovering the perpetrators with confidence is so vital.  As I've argued before, the anthrax attack was at least as important as (if not more important than) the 9/11 attack in creating a climate of fear in the U.S. that spawned the next decade's War on Civil Liberties and Terror and posture of Endless War; multiple government officials used ABC News' Brian Ross to convince the nation that Saddam was likely behind those attacks (as but one example, The Washington Post's Richard Cohen, in 2008, cited the anthrax attacks as his primary reason for supporting the attack on Iraq; in October, 2001, John McCain said on David Letterman's program that there is evidence linking Iraq to the anthrax attack).  Even if one believes the FBI's case, it means that one of the most significant Terrorist attacks in American history was launched from within the U.S. military.  As Alan Pearson -- Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation -- put it: 

If Ivins was indeed responsible for the attacks, did he have any assistance? Did anyone else at the Army lab or elsewhere have any knowledge of his activities prior to, during, or shortly after the anthrax attacks? . . . It appears increasingly likely that the only significant bioterrorism attack in history may have originated from right within the biodefense program of our own country.  The implications for our understanding of the bioterrorism threat and for our entire biodefense strategy and enterprise are potentially profound.

OH, and by the way (Thanks, Marcy!) one other correction made to FBI's brief was to delete the information that Ivins had sent anthrax spores to Bioport.  Bioport, maker of the US anthrax vaccine, has an excellent motive for the crime.  And Bioport has obtained contracts with the US government for 1.5 billion worth of anthrax vaccine since the letters were sent.  Did I mention that the anthrax vaccine program was undergoing a high-level review and was about to be cancelled by the Pentagon in the fall of 2001?

Justice Department Filing Casts Doubt on Guilt of Bruce Ivins, Accused in Anthrax Case/ PBS, McClatchy, ProPublica

From Mike Wiser, Greg Gordon and Stephen Engelberg come the following story:

Justice Department lawyers filed a brief on July 15 that said Bruce Ivins did not have access to equipment in the Fort Detrick hot suites that would have enabled him to make the dried anthrax found in letters to two Senators. 

... the filing in a Florida court did not explain where or how Ivins could have made the powder, saying only that the lab “did not have the specialized equipment’’ in Ivins' secure lab “that would be required to prepare the dried spore preparations that were used in the letters.” 

The filing was in response to a lawsuit against the government filed by the family of Bob Stevens, the first person to die from mailed anthrax in 2001.

Justice department lawyers have also claimed that

“drying anthrax is expressly forbidden by various treaties,” and “overt use of any of these methods, if noticed, would have raised considerable alarm and scrutiny.’’

Yet the government has dried anthrax, and contracted with the corporation Battelle to produce dried anthrax for a government project.  Our government has in the past used the argument that only offensive programs are banned by the Biological Weapons Convention, and that if the intent is to use dried anthrax for a defensive purpose, then it is allowed.

The Illusions of Psychiatry (part 2) by Marcia Angell/ NY Review of Books

Marcia Angell completes her tour de force analysis of the underpinnings of psychiatry and its medications in the second part of her article, "The Illusions of Psychiatry" in the NY Review of Books.

Hugh Grant gets back at Newscorp by bugging the guy who hacked him/ New Statesman

There has been plenty written about the nefarious tactics of Rupert Murdoch's Newscorp (and other publications) to get the dirt on celebs, politicians, and anyone unfortunate enough to be newsworthy.  It is hard to get one's arms around the scope of these revelations.  When Price Charles and the UK's top police are also victims of the bugging, do Rupert Murdoch and his ilk get a level of control over the lives of the bugged unforeseen before the electronic age?

A top cop was bugged, and was publicly flayed for fiddling the books and cheating on his wife.  He resigned... and then he went to work for a Murdoch publication.*  Among many pieces he wrote for Murdoch was one defending the thoroughness of an earlier bugging investigation by Scotland Yard!  The ability to potentially blackmail the pols, royals and police appears infinite, on top of the influence wielded solely by the amount of media penetration in the UK, US, Australia and other countries.

Rebeckah Brooks is a personal friend of David Cameron; both live in Oxford and go horseback riding together.  She also was a friend of Tony Blair.  Both Cameron and Gordon Brown attended her 2009 wedding.  Hello?  It looks like Rupert/ Rebeckah/News International is a kingmaker after all.

Although originally Australian, Murdoch is a naturalized US citizen.  However, he’s often referred to as the UK’s "permanent Cabinet member."  In Australia, Murdoch controls 70% of news readership.

The enormity of the implications of this level of eavesdropping are still hard for me to grasp.  But a true story written by actor Hugh Grant (the guy can write, too) starts to bring it down to a human level for me. Perhaps you too will find his personal tale of meeting and trading stories with a hacker of interest.

*  According to the NY Times  (This is a must-read to see how the police covered up an earlier investigation of phone hacking with 4,000 vixtims:  Andy Hayman, who as chief of the counterterrorism unit was running the investigation, also had several dinners with News International editors, including one in April 2006 while his officers were looking into the allegations. Hayman told Parliament he never discussed the investigation with editors.
Hayman left the Metropolitan Police in December 2007 and was soon hired to write a column for The Times of London, a News International paper. He defended the inquiry that he led, writing in his column in July 2009 that his detectives had "left no stone unturned."
Three months later, Wallis, the former deputy editor of News of the World, was hired by Scotland Yard to provide strategic media advice on phone-hacking matters to the police commissioner, among others.


UPDATE:  A useful article from which some tidbits were borrowed is this one from the July 15 WaPo/AP:  Phone hacking scandal casts light on Murdoch's political role around the globe.

UPDATE:  Head of Scotland Yard resigns over hacking scandal.

UPDATE:  Scotland Yard's #2 man quits as well.  The rotten core of modern political life is cracking open.  Can the fallout be contained?  Are there are any honest police left who are capable of interrogating their former (corrupt) leaders?  Will this investigation be conducted honestly, when the former ones were coverups?

FACT CHECK: Obama tells Muslim world vaccines aren’t CIA front, then runs CIA vaccine front/ AP

From Matt Appuzzo at the AP, published in the Washington Post, comes this amusing piece:

WASHINGTON — In his 2009 speech to the Muslim world, President Barack Obama announced a new effort to eradicate polio, which persists in three Muslim countries. One of the biggest hurdles had been persuading some local leaders that vaccination campaigns were independent health efforts, not nefarious programs being run by the CIA.

With the Obama administration’s assurances, Muslim scholars issued a religious decree that parents should vaccinate their children. The administration and public health officials cheered as the number of new polio cases began to fall in some hard-to-reach areas

Recently, however, as the U.S. closed in on Osama bin Laden’s compound in Pakistan, the CIA used a vaccine program as cover, a way to try to collect DNA from bin Laden’s family and confirm he was hiding inside a walled compound...

“It’s just so unfortunate. It’s the worst kind of labeling you could put on a public health campaign,” Bari said Wednesday. “Any backlash against this will hurt the children of Pakistan...”

DHHS continues to push for testing anthrax vaccine in children

Although the DHHS recently field-tested an informed consent document for parents (whose children were sought for an anthrax vaccine clinical trial in the Washington, DC public schools) it was reported that so far there were no takers.  This information was stated at a public meeting held July 7 by DHHS to discuss the ethics and logistics of testing anthrax vaccine in (unsuspecting and nonconsenting) children.

How were the Washington DC public schools chosen?  Aren't 90% of students black?  Was that a coincidence?

DHHS forgot that when CDC tried to push this vaccine on black Postal Service employees in 2001 there were also no takers.  Fortunately, our black citizens have not forgotten the Tuskegee experiments, and ponder whether clinical trials are conducted in the black community for reasons benign or malign.

Apparently someone at the meeting suggested that perhaps this trial could be performed overseas.  What an  ethically interesting response to DHHS' proposal that is.  But it does speak to the question posed at the meeting by Vera Sharav, president of the Alliance for Human Research Protection (AHRP):  Whose children will be used for this experiment?

I have been a member of the board of AHRP for 10 years.  Click here to read her comments and mine, and to learn more about the meeting.

In Ireland, Pandemrix vaccination associated with narcolepsy, but we're to rejoice it did not cause Guillain Barre/

Today, one Irish website (Irish Medical Times) rejoiced that a study just out in the BMJ showed Pandemrix swine flu vaccine, containing a novel GSK (GlaxoSmithKline) adjuvant, did not cause Guillain-Barre syndrome, a life-threatening form of temporary paralysis from which over 90% survive and make partial to full recoveries.  No mention is made in the article of the risk of narcolepsy.

UPDATE July 14:  It turns out that the BMJ study actually did NOT prove there was no increased incidence of GBS.  It only showed that the increased risk, if any, was at most 2.7 times higher in those vaccinated with Pandemrix, while back in 1976 the increased rate of GBS in the six weeks following swine flu vaccination was about 8.  But it sure got a lot of publicity, practically all of which incorrectly claimed there was no increased risk of GBS.  According to CIDRAP:

In the accompanying editorial, four specialists with the US Centers for Disease Control and Prevention (CDC) describe the findings as being in accord with studies on the GBS risk associated with nonadjuvanted pandemic H1N1 vaccines but as puzzling in some respects.

"Overall, the results suggest that if there was an increased risk associated with the adjuvanted 2009 H1N1 vaccines studied, it was considerably smaller than that seen with the 1976 flu vaccines," they write. "Whether there was an increased risk, however, is not clear."

Another Irish website (JOE) today noted instead that narcolepsy was associated with the same vaccine, and that over 6 times as many cases developed in those who received Pandemrix as in those who did not.  Narcolepsy is another life-threatening condition, and those who develop it do not recover.

[UPDATE July 15:  Finland's Minister of Health and Social Services has promised to help compensate victims of the swine flu vaccine program who developed narcolepsy.  So far, 96 cases have been diagnosed in Finland, resulting in 70 claims for compensation.  (Finland has only 5.3 million people.)]

There has been a suggestion that other neurologic conditions were associated with new narcolepsy cases, such as changes in personality*, but such changes are harder to quantify and little information has been made publicly available about them.  Because falling asleep involuntarily and unexpectedly is hard to mask or ignore, it is relatively easy to get a reliable count of severe narcolepsy cases.  Mild cases may be notoriously difficult to diagnose.

How much more likely are you to get narcolepsy if vaccinated?  Reports of preliminary studies indicated the risk was high in children and teens but not adults.  For an epidemiologist, once you know who is in a high risk goup, you can calculate how much more likely it is for members of the group to develop narcolepsy.  However, if you include in your calculations all those who got the vaccine, when only those between, say, ages 10 and 20 were at increased risk, you will dilute the degree of risk if you compare all age groups en masse.  In other words, the rate of new narcolepsy cases in all vaccinated people divided by the rate in all unvaccinated people will be much lower than the same comparison using only the smaller, at-risk group.  The cited article does not make clear which groups were compared, but earlier data suggested the risk in adolescents was approximately tenfold higher in the vaccinated.  The peak age of onset in all narcolepsy cases is 15.

Another issue to be clarified is the role of a gene that is known to predispose to narcolepsy.  While a genetic predisposition is important, the gene is commonly found, but the disease itself is rare.  So you cannot blame the gene for cases, although it may be a necessary prerequisite.  The vast majority of people with this gene will never develop narcolepsy.  Instead, narcolepsy is an autoimmune disorder, according to researchers at Stanford, where a lot of the genetic work was done.  Autoimmune disorders are believed to be due to attack by one's immune system on a particular tissue type:  by this reasoning, the vaccine likely triggers autoimmune destruction of a small number of cells in the hypothalamus that make a substance which helps regulate sleep, termed hypocretin.

This ABC News story gives a good idea about what it is like to live with narcolepsy, and also explains some of the science.

BTW, the baseline incidence of narcolepsy in Finland, where the association with Pandemrix was first noted, was no greater than in the USA, prior to use of vaccine for swine flu.

It is very hard to predict vaccine side effects in advance of vaccinating large numbers of people, but the most well-known (and probably the most common) serious side effects are both neurologic and autoimmune, from all vaccines.  And so that is where we should cast our net when trying to learn more about the safety of new vaccines in a post-marketing environment.  Surveillance for just Guillain-Barre is a road to disaster, as it is likely to miss the much bigger picture, and alone tells us nothing about the overall safety of a vaccine.

J Neurol Neurosurg Psychiatry. 2009 Jun;80(6):636-41. Epub 2009 Feb 11.
http://www.ncbi.nlm.nih.gov/pubmed/19211597

Psychological health in central hypersomnias: the French Harmony study.

Dauvilliers Y, Paquereau J, Bastuji H, Drouot X, Weil JS, Viot-Blanc V.

Source

Département de Neurologie, Hôpital Gui de Chauliac, 80 av Augustin Fliche, Cedex 5, Montpellier 34295, France. y-dauvilliers@chu-montpellier.fr

Abstract

BACKGROUND:

A large observational French study of central hypersomnia, including narcolepsy with cataplexy (C+), without cataplexy (C-) and idiopathic hypersomnia (IH), was conducted to clarify the relationships between the severity of the condition, psychological health and treatment response.

METHODS:

601 consecutive patients over 15 years of age suffering from central hypersomnia were recruited on excessive daytime sleepiness, polysomnography and Multiple Sleep Latency Test (MSLT) results. 517 (47.6% men, 52.4% women) were finally included: 82.0% C+, 13.2% C- and 4.8% IH. Face to face standardised clinical interviews plus questionnaires (Epworth Sleepiness Scale (ESS), short version Beck Depression Inventory (S-BDI), Pittsburgh Sleep Quality Index (PSQI) and 36-item Short Form Health Survey (SF-36)) were performed. Patients affected with a different diagnosis and with and without depressive symptoms were compared.

RESULTS:

Mean ESS and body mass index were higher in C+ compared with C-/IH patients. Half of the patients (44.9%) had no depressive symptoms while 26.3% had mild, 23.2% moderate and 5.6% severe depressive symptoms. C+ patients had higher S-BDI and PSQI and lower SF-36 scores than C-/IH patients. Depressed patients had higher ESS scores than non-depressed patients, with no difference in age, gender, duration of disease or MSLT parameters. Finally, C+ patients treated with anticataplectic drugs (38.7%) had higher S-BDI and lower SF-36 scores than C+ patients treated with stimulants alone.

CONCLUSION:

Our data confirmed the high frequency of depressive symptoms and the major impact of central hypersomnias on health related quality of life, especially in patients with cataplexy. We recommend a more thorough assessment of mood impairment in central hypersomnias, especially in narcolepsy-cataplexy.

Case Against Strauss-Kahn for Rape Falls Apart/ NY Times

I hate to say "I told you so" but here it is, from the NY Times.  Now one may ask, why was DSK presumed guilty and treated abominably at the onset of the case?  Still think this was not a political frame-up in which the USG was a major participant?  From today's NYT:

The sexual assault case againstDominique Strauss-Kahn is on the verge of collapse as investigators have uncovered major holes in the credibility of the housekeeper who charged that he attacked her in his Manhattan hotel suite in May, according to two well-placed law enforcement officials.

Although forensic tests found unambiguous evidence of a sexual encounter between Mr. Strauss-Kahn, a French politician, and the woman, prosecutors now do not believe much of what the accuser has told them about the circumstances or about herself...

Doctors who were paid $12-16 million pimped for Medtronic's poor quality spinal fusion material / NY Times

Finally, members of my profession are fighting back against corrupt doctors and the companies who pay lavishly for their undeserved testimonials.  Respected university bigwigs are just as susceptible as anyone else to 10 or 20 million dollar payoffs:  and they may feel they have no conflict of interest as a result and their work is pure.  (So claimed Dr. Thomas A. Zdeblick of the University of Wisconsin, who has earned $20 million from Medtronic for his patents, including those used with spinal fusions.)

Nonetheless, "scientific" studies get performed and written up and published that  misrepresent the truth, so that a product appears more effective and safer than it really is.  Medtronic paid big bribes, but earned about 900 million from this one product last year, used in 100,000 spinal fusions in 2010!

What is extraordinary is that finally many members of our profession have come out about the fraud, filling an entire issue of The Spine Journal to tell the other side of the story.  Medtronic is not a small player gone awry.  It is the largest medical device manufacturer in the US.  Below are excerpts from the NY Times:

 In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product. In a series of reports published in a medical journal on Tuesday, the specialists called the research misleading and biased. 

The repudiation, appearing in a full issue of The Spine Journal devoted to the topic, represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices. It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.

Medtronic, the nation’s biggest maker of medical devices, has been facing intensifying scrutiny over its promotion of Infuse, the bone growth product at the center of the controversy. The bioengineered material is used primarily in spinal fusions, a procedure in which spinal vertebrae are joined to reduce back pain.

Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none. 

“It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports. “It harms patients to have unaccountable special interests permeate medical research.”

“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”

“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”

It is too early to predict how the articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year. But the potential consequences seem significant...

The Epidemic of Mental Illness: Why? / NY Review of Books

This June 23, 2011 article by Marcia Angell, a former NEJM editor and a Harvard professor of medicine, is a must-read.  Actually, this article is only Part 1, and the second half will come out in two weeks.  Angell reviews 3 books on psychiatry, and asks all the right questions:

• Why are half of American defined as having a mental illness at some time in their lives?
• Why have the number of children receiving SSI income for a mental disability increased by a factor of 35 over the past 20 years?
• Why do people believe in the "chemical imbalance" theory of mental disorders when there is no evidence to support it?
• Why are new-generation antipsychotics the top-selling class of drugs in the US?
• What is going on here???
• If the drugs work, shouldn't the prevalence of mental illness be falling, not rising?
• Why are illnesses that used to be episodic now chronic, never-ending conditions?
• Are our drugs actually making matters worse?

Memo reveals intelligence chief wrote dossier on Iraqi WMD knowing that "in terms of WMD Iraq is not that exceptional"/ Guardian

From the Guardian, an article provides new information on how Tony Blair's administration lied to make the case for war in Iraq. What do you call this crime?  Is it treasonous to start a war under false pretenses, costing your country hundreds of lives and billions of dollars?  And what was it for, anyway?

The senior intelligence official responsible for Tony Blair's notorious dossier on Iraq's weapons of mass destruction proposed using the document to mislead the public about the significance of Iraq's banned weapons.
Sir John Scarlett, who as head of the Joint Intelligence Committee was placed "in charge" of writing the September 2002 dossier, sent a memo to Blair's foreign affairs adviser referring to "the benefit of obscuring the fact that in terms of WMD Iraq is not that exceptional".
The memo, released under the Freedom of Information Act, has been described as one of the most significant documents on the dossier yet published.
The disclosure supports the evidence of the former intelligence official Michael Laurie, who told the Chilcot inquiry into the Iraq war that it was widely understood that the dossier was intended to make a case for war and misrepresented intelligence to this particular end...

Use of Psychological Profile to Infer Ivins's Guilt Is Problematic/ Clinical Psychiatry News

Dr. Annette Hanson penned the following piece on the ethically impaired "Expert Behavioral Analysis Panel" paid for by FBI:

In March, a panel chaired by Dr. Gregory Saathoff, commonly known as the expert behavioral analysis panel (EBAP), released a report containing a summary and analysis of the investigation of Dr. Bruce Ivins, the suspected anthrax mailer. (1) The panel was convened at the request of the Chief Judge of the U.S. District Court, Royce C. Lamberth. The full report containing Dr. Ivins’s previously confidential and sealed medical information is being sold online by the Research Strategies Network, a non-profit organization that consults to the Department of Defense and whose president is Dr. Saathoff.(2) After reading the redacted executive summary, I felt compelled to review the work of the panel in light of standards set forth in the American Academy of Psychiatry and Law’s Ethical Guidelines for the Practice of Forensic Psychiatry.(3)

Although the panel undertook the investigation with “no predispositions with regard to [Dr. Ivins’s] guilt or innocence and in fact without a focus on that issue,” it nevertheless concluded that Dr. Ivins was the anthrax mailer. Dr. Ivins’s guilt has never been established in a court of law since he committed suicide in August 2008 and was never charged with the deaths of the five anthrax victims. This pronouncement of guilt is not consistent with the ethics and traditional practice of forensic psychiatry. Ethical guidelines state that forensic psychiatrists should: “...communicate the honesty of their work...by distinguishing, to the extent possible, between verified and unverified information as well as among clinical ‘facts,’ ‘inferences, and ‘impressions.’ ” The panel report concluded guilt based upon “considerable circumstantial evidence” found in the medical records without acknowledging that this conclusion was based on psychodynamic inference. Specifically, the report found that Ivins had the “psychological disposition,” motive, means and the “behavioral history” to carry out the attacks. The use of a psychological profile to infer guilt is particularly problematic, since this evidence is not admissible in most jurisdictions. Bioterrorist profiles are likely more unreliable than most given the paucity of subjects upon which to base a profile.

From an ethical standpoint, the sale of the panel report is particularly problematic. Forensic reports are generated at the request of the retaining agency or individual, and the information in the report is usually not distributed beyond the parties immediately involved in the proceedings. The forensic evaluator himself does not typically distribute a report to non-involved individuals, nor does the evaluator sell the report to the public. While Dr. Ivins signed several releases of information during the course of his career, it is unlikely that he could have foreseen or given knowing consent to worldwide sale of his medical information. The panel report details Dr. Ivins’s social awkwardness and eccentricities, romantic rebuffs, and early childhood abuse while making careful note that his early abuse did not “exonerate” him for the criminal acts of which he is presumed guilty.

Although the investigation was requested by the court, the panel’s work product was intended to benefit national security investigators. According to the website of the Research Strategies Network, which organized the panel, the RSN has previously collaborated with the F.B.I. and the Department of Defense. This creates an appearance of conflict of interest and bias, a common problem among mental health professionals who consult with law enforcement agencies. Psychologists who consult with law enforcement have ethical guidelines that caution against these dual agency roles due to the risk of unintended bias and the danger of distortion when forming an opinion.
Although the majority of the expert behavioral analysts on the panel are not board-certified forensic psychiatrists, standard practices and ethical guidelines still apply. Many people who read the report will be struck by Dr. Ivins’s distasteful traits and behaviors, and some may be convinced of his guilt. This should not detract from the larger issue of the proper role and duties of psychiatrists in such investigations.

1. Executive summary of the expert behavioral analysis panel. Accessed at https://www.researchstrategiesnetwork.org/pages/view/Amerithrax/ on June 5, 2011
2. The Amerithrax case: report of the expert behavioral analysis panel. Accessed at
www.lulu.com/product/paperback/the-amerithrax-case-report-of-the-expert-behavioral-analysis-panel-%28redacted-version%29/15208937 on June 14, 2011

3. American Academy of Psychiatry and Law. Ethics guidelines for the practice of forensic psychiatry. Accessed at www.aapl.org/ethics.htm on June 17, 2011

FDA Anger over Australian flu vaccine investigation/SMH

From the Sydney Morning Herald comes this piece that says our FDA found CSL's "investigation" of why so many children had seizures post-vaccination to be entirely inadequate.  If you don't find the problem then you don't have to make any expensive changes to your manufacturing facility.  And you are not liable for willful misconduct, which would be the case were you to find the problem yet continue to sell products whose mode of manufacture had not been upgraded.

THE US drugs watchdog has slammed Melbourne-based drug manufacturer CSL for mounting an ''inadequate'' investigation of convulsions suffered by children who had used its flu vaccine.
CSL withdrew the vaccine, sold as Fluvax in Australia and Afluria in the US, for use on children under five in June last year after it was linked to convulsions and fevers.

But the company has yet to discover why the dangerous side effects were far more common in young children vaccinated with Fluvax than those who used other brands.

 

In a letter sent to CSL, the Food and Drug Administration lists 15 ''significant deviations'' from drug manufacturing standards uncovered during an inspection of CSL's Parkville facility in March.

''You failed to thoroughly investigate any unexplained discrepancy, or the failure of a batch [of vaccine] or any of its components to meet any of its specifications,'' the FDA's head of compliance, Mary Malarkey, said in the letter, dated June 15.
Ms Malarkey told CSL that their response so far had failed to take a ''more global approach'', including closer scrutiny of raw materials used during drug making.
CSL spokeswoman Sharon McHale said that the company had 15 days to submit a detailed response.

''We're working on our response now and will meet that deadline,'' she said.
The company will then meet with the FDA, probably in the first half of next month.
''If they say our response is adequate we'll continue to implement our action plan,'' Ms McHale said.

''If they feel as though we haven't complied, then they can take regulatory action.''
Ms McHale said that if the FDA was not comforted by CSL's response, ''it can impact our ability to provide vaccine into the US market''. Flu vaccine forms a relatively small part of CSL's $4.6 billion a year in revenue, with worldwide sales last financial year totalling $124 million, of which $53 million was sold in the US.
Convulsions hit between five in 1000 and seven in 1000 children under three vaccinated with Fluvax last year, according to a study by Australian drug regulator the Therapeutic Goods Administration. The baseline rate, observed in a five-year US study, is less than one in 1000.

A TGA survey of hospital data also found children under five vaccinated with Fluvax were between three and 6.5 times more likely to have a fever than users of competing products.
The TGA said that as a working hypothesis a higher concentration of the enzyme neuraminidase due to the inclusion of a swine flu vaccine might have caused the additional convulsions.

''However, despite extensive analyses the biological basis for the excess cases of fever and febrile convulsions remains unclear,'' the TGA said in its report, issued in October.
CSL no longer sells Fluvax for use on children under five and its use on children aged between five and 10 is now only recommended if no other vaccine is available.

What DHHS proposes to tell parents about giving anthrax vaccine to their children

In order to meet the requirements of 45 CFR 46.407, a federal advisory panel must review the proposed pediatric research, agree that it will provide important generalizable knowledge, and that children participating in the research will be protected from taking dangerous risks.  DHHS has convened the necessary panel, which will meet to discuss details of the proposed research on July 7, 2011.  The research is only legally approvable if it meets accepted ethical standards and children are protected from potential serious harm.  In order to appear to meet this requirements, the vaccine is being billed as perfectly safe.  The whitewash is being carefully prepared.  The fun begins at the Washington Plaza Hotel, 10 Thomas Circle, Northwest Washington, DC between 9 and 4:30 pm.  Note the colored text below, where parents are not being told the whole truth about what their children may experience.  Such inadequate disclosure might be seen as willful misconduct on the part of those conducting the study, since they have failed to fairly review the prior body of literature on anthrax vaccine side effects.--Meryl Nass, M.D.

Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers

The population has been told by public health authorities that they were in an area deemed to be exposed to anthrax spores. Public health officials have antibiotics and anthrax vaccine available.
Dialogue of parent to provider:
1. Q - Is my child at risk for developing anthrax?

A - Yes. If your child was exposed to anthrax spores, your child is at risk. 2. Q - What treatments are available?

A - Your child will need to take an antibiotic for two months. A vaccine is also available. 3. Q - Should I get my child vaccinated?

A- Based on what we know about the use of the vaccine in adults, public health officials believe it will provide benefit to your child, however, this has not been previously examined. Your child would still need to take the antibiotics. The vaccine should prevent the disease from occurring after the antibiotics have been stopped. 4. Q - What is the anthrax vaccine?
A - The vaccine is a preparation of proteins from the anthrax bacteria. Vaccination
results in an immune response (the body develops antibodies to ready to fight an infection). The immune response kills and clears the anthrax bacteria. 5. Q - Has this product ever been given to children before?

A- No, the product has never been given-to or evaluated-in children before. 6. Q - How do you know this vaccine is safe for my child?

A - Public health and other experts have reviewed all the available safety data collected
as this vaccine is used in adults and from that believe that the vaccine should be safe in children. Like other vaccines, anthrax vaccine is expected to produce local discomfort, pain, and swelling at the injection site that usually goes away. 7. Q - Do you know if the anthrax vaccine will work in children?
A - Based on the data used to support FDA licensure, public health officials and other
experts, believe it will work, however, there are no data on effectiveness in children or in adults for that matter. 8. Q - How do you know how much vaccine to use for children?
A - The pediatric dose is based on the dose given to adults. We expect this dose will
result in the same protective response. We simply will not know unless we study the immune response in children of different ages. 9. Q - Why does my child need both an antibiotic and a vaccine? What are the risks if my

child does NOT receive the anthrax vaccine? A - If your child was exposed to anthrax spores, your child will need to complete a

2-month course of antibiotics. Antibiotics do not kill anthrax spores. The antibiotics work directly against the active anthrax bacteria. The bacteria were delivered as

*

Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers – continued

spores, which are very hardy and when they germinate, or “hatch” the resulting bacteria cause the disease. These spores can last several months in the body before hatching. The anthrax vaccine prepares the immune system to directly attack the anthrax bacteria and gives protection beyond the 60-days of antibiotics. As with other bacteria, anthrax bacteria may develop resistance to antibiotics. Also, we do not know enough yet about long-term exposure risks from living in an area that has been contaminated with spores from an attack. 10. Q - Does the anthrax vaccine cause anthrax disease?

A - No. The vaccine cannot cause anthrax. 11. Q - What are the risks if my child does get vaccinated – will the vaccine harm my child?

A - The vaccine causes a local reaction that can be mild or severe, with local pain,
swelling and difficulty moving the arm. This reaction can last for days or even longer before going away. As with other vaccines, your child may experience muscle aches, fatigue, and headache. These will go away. Rarely, your child may have a serious allergic reaction within minutes after vaccination and require medication to treat. We will watch for this after your child has been given the vaccine. 12. Q - Will my child be protected against anthrax for life?
A - No. The three doses of vaccine your child will receive are for this particular event.
Based on the data we have at this time, it will not protect your child for life.
13. Q - If your child were exposed to anthrax, would you want them to get the vaccine?
14. Q - Since we do not know the exact dose of vaccine to give your child and its protective
ability, except for the adult dose and data, would you want the US government to collect data on pediatric dosing and protective ability ahead of time, that is, before an exposure? A study done prior to an exposure would help us decide whether the dose that we would use after an exposure is the preferred dose for protecting your child while likely minimizing any side effects.
15. Q - Since we do not know the exact dose of vaccine to give your child and its protective
ability, except for the adult dose and data, would you want the US government to collect data on pediatric dosing and protective ability during an event, that is, after an exposure? A study done only after an exposure would need to start with the adult dose that we believe will be effective, as a lower dose may not be effective. We will not know if this is necessary, since a lower dose may be as protective, but with fewer side effects. Enrolling your child in a study will help us figure this out for future children (or future doses for your child).

Fukushima lesson: You can't rely on govt or industry when a real crisis comes along/ NY Times

Most detailed look yet at the flawed decision-making and terrible information sharing between TEPCO, government bureaucrats, political leaders and outsiders during Japan's nuclear crisis by the NY Times:

Reuters

The Fukushima Daiichi nuclear plant, damaged by a tsunami on March 11, became the site of the worst nuclear disaster since Chernobyl, as workers successfully warded off a complete meltdown, but could not prevent the release of considerable amounts of radioactive material.

In nuclear crisis, crippling mistrust

TOKYO — On the evening of March 12, the Fukushima Daiichi nuclear plant’s oldest reactor had suffered a hydrogen explosion and risked a complete meltdown. Prime Minister Naoto Kan asked aides to weigh the risks of injecting seawater into the reactor to cool it down.

MASAO YOSHIDA The manager of the power plant, he ignored orders to stop pumping seawater into a reactor to cool it, an act of defiance that may have prevented many deaths.

At this crucial moment, it became clear that a prime minister who had built his career on suspicion of the collusive ties between Japan’s industry and bureaucracy was acting nearly in the dark. He had received a confusing risk analysis from the chief nuclear regulator, a fervently pro-nuclear academic whom aides said Mr. Kan did not trust. He was also wary of the company that operated the plant, given its history of trying to cover up troubles.
Mr. Kan did not know that the plant manager had already begun using seawater. Based on a guess of the mood at the prime minister’s office, the company ordered the plant manager to stop.
But the manager did something unthinkable in corporate Japan: he disobeyed the order and secretly continued using seawater, a decision that experts say almost certainly prevented a more serious meltdown and has made him an unlikely hero.
The convoluted drama has exposed the underlying rifts behind Japan’s handling of the worst nuclear disaster since Chernobyl, which eventually resulted in explosions at four of the plant’s six reactors. Mutually suspicious relations between the prime minister’s aides, government bureaucrats and company officials obstructed smooth decision-making...

F.B.I. Agents Get Leeway to Push Privacy Bounds/NYT

More on America's widening surveillance state from the NY Times:

The Federal Bureau of Investigation is giving significant new powers to its roughly 14,000 agents, allowing them more leeway to search databases, go through household trash or use surveillance teams to scrutinize the lives of people who have attracted their attention.

Valerie E. Caproni, the F.B.I. general counsel, said the bureau had carefully considered each change to its operations manual.

The F.B.I. soon plans to issue a new edition of its manual, called the Domestic Investigations and Operations Guide, according to an official who has worked on the draft document and several others who have been briefed on its contents. The new rules add to several measures taken over the past decade to give agents more latitude as they search for signs of criminal or terrorist activity.

The F.B.I. recently briefed several privacy advocates about the coming changes. Among them, Michael German, a former F.B.I. agent who is now a lawyer for the American Civil Liberties Union, argued that it was unwise to further ease restrictions on agents’ power to use potentially intrusive techniques, especially if they lacked a firm reason to suspect someone of wrongdoing...

Attorney General Dominic Grieve refuses to order an inquest on death of David Kelly

After David Cameron recently said a full inquest into David Kelly's death was unnecessary, it was no surprise that his Attorney General soon afterward echoed his statement.  Excerpts from the BBC:

On the day Dr Kelly's body was discovered, then Prime Minister Tony Blair asked Lord Hutton to conduct an urgent investigation into the circumstances surrounding the death.

Unusually, the inquest opened into Dr Kelly's death was never completed.

Lord Hutton released his findings in January 2004, reporting that the scientist had committed suicide by slashing his wrist with a blunt gardening knife.

Lord Hutton requested that the details of the post-mortem examination and toxicology tests be classified for 70 years - to protect the privacy of the Kelly family.

Why have there been calls for an inquest?

A group of doctors have mounted a long-running campaign for the inquest into Dr Kelly's death to be re-opened, arguing that Lord Hutton's suicide verdict was unsafe.

"No coroner in the land would have reached a suicide verdict on the evidence which Lord Hutton heard," they say.

They believe Dr Kelly's wrist wounds were not likely to be life-threatening, making the official cause of death - a haemorrhage - "extremely unlikely".

They say unanswered questions surrounding the death remain, including:

    * why no fingerprints were found on the knife apparently used to slit his wrist

    * how Dr Kelly obtained a packet of coproxamol painkillers

    * why his blood and stomach contained only a non-toxic dose of the drug

    * why he was not spotted by a police helicopter with thermal imaging cameras which    

       flew over the wood where his body was later found

    * whether he intended to kill himself

In September last year they petitioned Attorney General Dominic Grieve for the re-opening of inquiries.

It "may represent one of the gravest miscarriages of justice to occur in this country", the doctors said in a letter in March appealing to Prime Minister David Cameron to intervene on their behalf.

But, in June 2011, Mr Grieve rejected the doctors' petition. He said his department had thoroughly investigated their complaints and could not find any legal basis for referring the case to the High Court, which has the legal authority to order an inquest.

Following the government's decision, the doctors who had petitioned Mr Grieve called for his resignation.

Campaign leader Dr Stephen Frost said: "The continuing cover-up of the truth of what happened is a national disgrace and should be of concern to all British citizens."

The group will now seek to take the decision to judicial review.

From the Daily Mail, more on the story, including a piece by Sue Reid titled, "Questions that Still Demand an Answer."

Why we are still in Afghanistan: One trillion $ in minerals/NPR

 Mines, like this one in  Badahkshan, could lift Afghanistan out of poverty (NPR)

From National Public Radio, information on how the Pentagon is working to develop business opportunities in Afghanistan for US corporations:

There's close to a $1 trillion waiting to be unearthed beneath the rocky soil of Afghanistan. The massive deposits of iron, copper, gold and lithium could potentially turn the troubled nation's economy around.
"Afghanistan, with certainty I can say, in 20 years is going to be a mining country," Paul Brinkley, head of a Pentagon group called the Task Force for Business Stability Operations, tells NPR's Rachel Martin. "That is going to happen."...

As part of his efforts, Brinkley brings in corporate executives on trips to Afghanistan to try to get them to invest. An array of executives, including from Citibank, IBM and even Kate Spade, have accompanied Brinkley on these types of trips. When he's making his pitch, he wants to make it clear this is not a charity opportunity. It's strictly business.
"I want them to come in and see that they can make actually make money, that there's a market," Brinkley says, "that there's talent that can be brought to bare for their particular business interests."
High-Risk Investments
But these possible business opportunities are still located in a volatile, dangerous environment. With the task force moving to the civilian-run U.S. State Department, the risk is greater.
State Department personnel are "not trained to be in combat zones," notes Nathan Hodge, author of Armed Humanitarians, "they're not trained to be in combat zones, and very often you're talking about doing this kind of armed development work while being shot at."
Those are the same concerns some lawmakers have on Capitol Hill, saying Brinkley's task force blurs the line between military and civilian missions. They think taking CEOs around Afghanistan is not something the Pentagon should be doing.
Brinkley has had his own close calls. In January 2010, a bomb went off in a Baghdad hotel where he was holding a meeting. Even after that close shave, Brinkley and his team only had one thought.
"Our immediate reaction was we're going right back in," he recalls.
Having A Stake
Once the minerals are extracted from the ground, Brinkley is faced with the reality of possible corruption — his greatest concern. He doesn't want minerals to become the blood diamonds of Afghanistan. To combat this worry, the task force makes sure Afghans have access to mining industry experts.
The overall key, according to Brinkley, is engagement. By staying involved, he says, the U.S. has the ability to better shape the outcome. He also notes, the U.S. does have a strategic interest in seeing Afghanistan develop...

More on the bureaucratic challenges of injecting children " with no clear benefit" with anthrax vaccine/DHHS

See here for a detailed discussion of the expanding anthrax vaccine stockpile, vaccine maker Emergent Biosolutions, and the illegality of shooting up children with an anthrax vaccine potion that is too dangerous for adults.

*

WHO: Radiofrequency radiation from cell phones and other sources a possible carcinogen

From the Washington Post:

“After a weeklong meeting on the type of electromagnetic radiation found in cellphones, microwaves and radar, the expert panel said there was limited evidence cellphone use was linked to two types of brain tumors and inadequate evidence to draw conclusions for other cancers.”

This whole issue is totally gummed up by conflicts of interest.  The telecoms industry has sponsored much of the research. But several weeks a go a paper out of China provided powerful epidemiologic evidence for cell phone use and parotid gland tumors.  (This salivary gland is located just below and in front of the ear.)  Other tumors that have been linked to cell phone use include acoustic neuroma (a common, benign tumor of the cranial nerve to the inner ear), glioblastoma multiforme (a very malignant brain tumor seen most often in older ages) and meningioma (usually benign tumors of the brain and spinal cord lining).  Although benign, these tumors still require very delicate brain surgery, and may still kill the patient.

The Interphone study, a multicountry many year study of the effects of cellphones has suffered from hidden data and other issues.  Louis Slesin's well-regarded Microwave News has detailed the backstory of this very expensive project.

Another important, recently published piece of this puzzle is an NIH paper that showed exposure to radiofrequency radiation similar to that from a phone antenna significantly increased brain glucose metabolism in areas experiencing highest signal strength.

It appears the tide has turned on this contentious issue.

On May 27 the Council of Europe adopted Resolution 1815 (2011):
The potential dangers of electromagnetic fields and their effect on the environment

-- whose text can be read here.

What to do?  Luckily, there are easy fixes.  Keep the phone away from your body, with an earpiece/headset or bluetooth device, since exposure is inversely proportional to the square of the distance from your tissues.  (Even the package inserts tell you to keep the phone away; do you still have the information that came with your cell phone?)  Use landlines (even better if they are not wireless).  Or texting.  Or email.

A peculiarity of US law:  citizens are not allowed to reject the siting of cell phone towers on the basis of health risk for anything other than thermal effects.*  Let me restate that.  The law is a pre-emptive strike against the kinds of scientific research that now point to adverse effects of radiofrequency radiation (including microwaves) in addition to, and different from, the effect of heating up tissue.  The law basically assumes such effects cannot exist, and prevents citizens from using such effects to fight cell tower installations.

With this law in mind, the local school superintendent recently announced that a cell tower would be placed at our high school, currently a dead zone for cell phones.  If it doesn't cook you, the US Government has made it safe, by decree.

Unlimited service may give us new freedoms, but it has its own price.

UPDATE:  The August 18, 2011 NY Times carried an article from San Francisco on the paradoxical warnings required by federal regulation in areas where radiofrequency antennae are installed as cell towers, while federal law prohibits any consideration of health effects in local decisions about siting of the towers. 

*  1. Federal law prohibits state and local agencies, including zoning boards, from basing tower/antenna
siting and construction permits on the harmful environmental effects of radiofrequency (RF) radiation
emissions “to the extent that facilities comply with” the Federal Communication Commission’s (FCC)
regulations.  [47 USC Sec. 332( c)(7)(iv)].  Courts and the FCC have interpreted this law to apply to
“human health.”
     2. FCC RF safety standards are based on protection of humans against thermal effects from high
power levels of RF radiation.  The FCC radiation limits do not protect people from adverse
biological effects of long term RF exposure or take into account the impact on children
or other especially vulnerable citizens.   
     3. Legal advocates argue that FCC RF safety standards do not extend to harmful effects on animals or
wildlife. Test cases to determine this are pending in the courts.