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...