Medical Professionals Not Sufficiently Vaccinated for Flu in Canberra, Australia / Canberra Times

Canberra, Australia's capital, has about 365,000 people and has a medical school.  Its health staff totals 5,122 people.  Only 48% were vaccinated against the flu this year, down from 60% during the swine flu pandemic of 2009.

But is this a problem?

ACT Health said there have been fewer than five deaths a year for each of the last five years in the capital, including no deaths in 2008 and 2010.

So in the worst case scenario, there were as many as 12 flu deaths in Canberra in the last 5 years, or 2.4 deaths per year, or 6.6 deaths per million per year.  Yet the US CDC estimate for flu deaths is 100 per million population per year.

According to the Australian government,

In most years, minor or major epidemics of type A or type B influenza occur, usually during the winter months. In Australia, 85 deaths and 4250 hospitalisations are notified, on average, per year, although this is almost certainly an underestimate due to failure to recognise the excess mortality and hospitalisation associated with the disease. Extrapolation from US estimates, based on more detailed surveillance, suggests 2000 deaths and 10 000 hospitalisations are likely to occur annually in Australia.

Eighty-five deaths divided by 26 million Australians yields 3.3 deaths per million population per year from flu.  Contrast this with 2-5 excess cases of Guillain Barre syndrome per million people vaccinated for swine flu, unknown other risks from the shot, and the net benefit (benefit minus risk) of flu vaccinations pales.

So, based on US estimates, Australian deaths would be expected to be 24 times greater than the identified death rate from influenza.  But Australia can't find the excess 1,915 deaths yearly.  Despite a national health plan and excellent surveillance.  CDC and WHO have had the same problem.

After vaccination, pigs experience much more severe disease when exposed to swine flu virus / Veterinary Pathology

As has been noted previously, vaccination is a black art, basically a trial and error process of discovery, which has the potential to either prevent or enhance disease, and therefore must be studied carefully before vaccines are administered to large populations, despite issues of expediency.  

Vet Pathol. 2012 Mar 28.

Kinetics of Lung Lesion Development and Pro-Inflammatory Cytokine Response in Pigs WithVaccine-Associated Enhanced Respiratory Disease Induced by Challenge With Pandemic (2009) A/H1N1 Influenza Virus.

Gauger PC, Vincent AL, Loving CL, Henningson JN, Lager KM, Janke BH, Kehrli ME Jr, Roth JA.

Abstract

The objective of this report was to characterize the enhanced clinical disease and lung lesions observed in pigs vaccinated with inactivated H1N2swine δ-cluster influenza A virus and challenged with pandemic 2009 A/H1N1 human influenza virus. Eighty-four, 6-week-old, cross-bred pigs were randomly allocated into 3 groups of 28 pigs to represent vaccinated/challenged (V/C), non-vaccinated/challenged (NV/C), and non-vaccinated/non-challenged (NV/NC) control groups. Pigs were intratracheally inoculated with pH1N1 and euthanized at 1, 2, 5, and 21 days post inoculation (dpi). Macroscopically, V/C pigs demonstrated greater percentages of pneumonia compared to NV/C pigs. Histologically, V/C pigs demonstrated severe bronchointerstitial pneumonia with necrotizing bronchiolitis accompanied by interlobular and alveolar edema and hemorrhage at 1 and 2 dpi. The magnitude of peribronchiolar lymphocytic cuffing was greater in V/C pigs by 5 dpi. Microscopic lung lesion scores were significantly higher in the V/C pigs at 2 and 5 dpi compared to NV/C and NV/NC pigs. Elevated TNF-α, IL-1β, IL-6, and IL-8 were detected in bronchoalveolar lavage fluid at all time points in V/C pigs compared to NV/C pigs. These data suggest H1 inactivated vaccines followed by heterologous challenge resulted in potentiated clinical signs and enhanced pulmonary lesions and correlated with an elevated proinflammatory cytokine response in the lung. The lung pathology and host immune response is consistent with the vaccine-associated enhanced respiratory disease (VAERD) clinical outcome observed reproducibly in our swine model.

FDA lawyers authorized spying on agency’s employees, senator says / WP

 Ellen Nakashima at the Post reports that Charles Grassley has evidence the Office of General Counsel at FDA authorized extensive spy probe of disgruntled employeess, Congressional offices and media.  This suggests authorization came from the highest levels at FDA:

"Congressional investigators said Monday that the chief counsel’s office at the Food and Drug Administration authorized wide-ranging surveillance of a group of the agency’s scientists, the first indication that the effort was sanctioned at the highest levels. 

In a letter to the FDA, Sen. Charles E. Grassley (R-Iowa) said that his staff had learned that the spying was “explicitly authorized, in writing” by the agency’s top legal office.
“The FDA’s actions represent serious impediments to the right of agency employees to make protected disclosures about waste, fraud, abuse, mismanagement, or public safety,” wrote Grassley, who demanded that the agency release a copy of the memo authorizing the surveillance and the name of the FDA official who requested it..."

$214 M CDC Lab Can't Contain its Germs / CNN and USAToday

One CDC high-containment lab (BSL-3, the level of containment required to study anthrax) fails to contain air efflux.  And it was discovered because visitors touring the facility saw a puff of air exit through a slot in a door window.  How long had this been going on?  

USAToday points out that the BSL-3 lab doors aren't always locked, either.

... Ebright, of Rutgers University, expressed concern about the repeated issues revealed in news reports about Building 18 since the $214 million building opened in 2005, including articles in 2007 about backup generators that failed to keep airflow systems working during a power outage, and in 2008 about a high-containment lab door that the CDC sealed with duct tape after an incident where an airflow system malfunctioned and sent potentially contaminated air into a "clean" corridor... 

CNN has the first story:

It's a highly secured, sophisticated research lab studying deadly diseases such as bird flu, monkeypox, tuberculosis and rabies.

It's in a facility called Building 18, which cost taxpayers $214 million.

And now, the Biosafety Level 3 lab at the Centers for Disease Control and Prevention in Atlanta is also the subject of a congressional investigation after a potentially dangerous airflow leak at that lab, CNN has learned.

The leak occurred on February 16, when air flowed the wrong way out of a germ lab into a clean-air corridor, rather than through the powerful HEPA filter that cleans the air, congressional sources and CDC officials said. Visitors touring the facility were in the clean corridor when they observed a puff of air being pushed out from the lab through a slot in a door window.

The leak occurred on February 16, when air flowed the wrong way out of a germ lab into a clean-air corridor, rather than through the powerful HEPA filter that cleans the air, congressional sources and CDC officials said. Visitors touring the facility were in the clean corridor when they observed a puff of air being pushed out from the lab through a slot in a door window... 

In 2008, it was discovered that a high-containment lab door was sealed with duct tape. That incident was first reported by the Atlanta Journal-Constitution and confirmed to CNN by Skinner.

In Vast Effort, F.D.A. Spied on E-Mails of Its Own Scientists / NY Times

The FDA, reprising the Justice Department, had its own criminal enterprise going.  Using commercial $99.95 spy software, it was able to illegally read emails of its employees, members of Congress and their staffs, and journalists, and much more.


Eric Lichtblau and Scott Shane of the NY Times report, although who authorized the illegal surveillance and who at FDA received the information are not disclosed in this article.

A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.

What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.

F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.

While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”

The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications.

With the documents from the surveillance cataloged in 66 huge directories, many Congressional staff members regarded as sympathetic to the scientists each got their own files containing all their e-mails to or from the whistle-blowers. Drafts and final copies of letters the scientists sent to Mr. Obama about their safety concerns were also included...

While federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government.

Other administration officials were so concerned to learn of the F.D.A. operation that the White House Office of Management and Budget sent a governmentwide memo last month emphasizing that while the internal monitoring of employee communications was allowed, it could not be used under the law to intimidate whistle-blowers. Any monitoring must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing,” the memo said.

Although some senior F.D.A. officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation.

But Stephen Kohn, a lawyer who represents six scientists who are suing the agency, said he planned to go to federal court this month seeking an injunction to stop any surveillance that may be continuing against the two medical researchers among the group who are still employed there...

While national security agencies have become more aggressive in monitoring employee communications, such tactics are unusual at domestic agencies that do not handle classified information...

FBI to review thousands of old cases for contaminated evidence / MSNBC

The FBI crime lab seems to have been run as an illegal enterprise to support desired convictions--evidence be damned--for decades.  Maybe justice will now be served for some of those convicted as a result of FBI criminality.

This story didn't  just come out.  There was a Justice Department review years ago... which let the original prosecutors review their own evidence, to decide whether to share it with the defense!  Would you have shared new evidence, when overturning your successful prosecutions could destroy your career?

Thanks to the Post, MSNBC, Attorney David Colapinto and FBI whistleblower Frederic Whitehurst:

Months after the Washington Post revealed that lab technicians at the FBI mishandled evidence, resulting in at least three wrongful convictions, the Department of Justice has announced it will review of thousands of old cases.

The review, the largest in U.S. history, will focus on work by FBI Laboratory hair and fiber examiners since at least 1985, the Post reported.

In April, the Post wrote about two men who were convicted largely because of contaminated FBI hair analysis. A review of the evidence has since resulted in the release of both men... 

A reporter at the Post had been working on a story about Donald Gates, a D.C. man released after DNA evidence proved his innocence, when he learned about Frederic Whitehurst, an FBI lab chemist who blew the whistle on the FBI Laboratory in the mid-1990s. Whitehurst said he watched colleagues contaminate evidence and, in court, overstate the significance of their matches...

After the first World Trade Center bombing, Whitehurst testified that supervisors pressured him to concoct misleading scientific reports. When he refused to testify that a urea nitrate bomb had been the source of the explosion, the FBI found another lab technician to testify...

“You get patted on the head if you’re the guy who saves the case,” Whitehurst said, explaining why agents would provide misleading information. “They get promoted; they’re the guys everyone crowds around. It’s a very tight family. A scientist who asks a question and doesn’t go along, he gets isolated.”

Corrupt lab technicians remained employed even after Whitehurst started speaking out about the lab, said David Colapinto, general counsel for the National Whistleblowers Center...

As an agent, Whitehurst wrote 237 letters to the Inspector General, complaining about the lab. The longest was 640 pages.

“The pressure was so crazy that every so often, I’d just break down and cry,” he said.  

The Justice Department ultimately did review thousands of cases in response to Whitehurst's reports, Colapinto said, but he said the task force assigned to investigate operated in secret and the findings were not published. Rather, Colapinto said, prosecutors who had originally tried those old cases decided whether the new evidence should be disclosed to the defense.

Dissatisfied with the Justice Department’s review, Whitehurst requested the task force's findings through the Freedom of Information Act. Over several years, he received tens of thousands of pages.Some changes were made, however. The FBI moved its lab from the FBI’s J. Edgar Hoover building in Washington, D.C. to a separate building in Quantico, Va. 

The National Academy of Sciences recently pushed for further independence, however. The organization, made up of elite scientists from around the U.S., recommended the creation of an independent federal agency to review evidence. That agency, ideally, should not be connected to the academic community, the scientists said. 

Whitehurst, now a forensic consultant and a criminal defense lawyer in North Carolina, and the National Whistleblowers Center worked with the Post for a year on the expose that came out in April. That story apparently pushed the Justice Department to conduct another, more transparent review of old evidence.

The Justice Department says that this time, the review will include outsiders such as the Innocence Project, according to The Associated Press. The Innocence Project, which focuses on exonerating the wrongfully convicted, would watch over the government’s review.

The FBI did not respond to request for comment.  

 

Live Avian Vaccines Recombine to Cause Disease They Were Intended to Prevent / Wired and ScienceNOW

From Wired and ScienceNOW comes this very worrisome piece about how two different, attenuated live virus vaccines for infectious laryngotracheitis in chickens recombined to form a virus twice as deadly as the disease the vaccines were intended to prevent.  (The death rate in chickens increased from 8% to 17%.)  Chickens in multiple parts of Australia were affected, beginning in 2008.

The new strains (termed class 8 and 9) have since become dominant, edging out the wild-type viruses.  There is no comment as to whether the strains have spread beyond the island nation of Australia.

Articles discussing problems with vaccine safety or efficacy always end with a statement that the information provided in no way challenges the great benefits of vaccinations, in general--and this article is no exception.  However, an article from the Australian Broadcasting Company makes clear the implications for humans as well as livestock are real:

Live vaccines, where a weaker version of the virus is introduced to allow the immune system to build up its own defences, are quite commonly used for animals and humans, and include polio, measles, mumps, rubella, chicken pox and rabies.

The Australian Pesticides and Veterinary Medicines Authority is now consulting with industry to control the use of these vaccines.

'Wider implications'

Co-researcher Professor Glenn Browning says other creatures could also be under threat of vaccines combining.

"We suspect that this sort of event could potentially happen in other animal species as well and with other viruses in addition to infectious laryngotracheitis virus," he says.

"So we believe that what we've seen here has potentially wider implications than just this particular disease in poultry..."

Farmed chickens are dying from a recombined vaccine. Image: NRCS/USDA

By Kai Kupferschmidt, ScienceNOW

Vaccines aren’t supposed to cause disease. But that appears to be what’s happening on Australian farms. Scientists have found that two virus strains used to vaccinate chickens there may have recombined to form a virus that is sickening and killing the animals. “This shows that recombination of such strains can happen and people need to think about it,” says Glenn Browning, a veterinary microbiologist at the University of Melbourne, Parkville, in Australia and one of the co-authors on the paper.

Chickens worldwide are susceptible to a group of herpesviruses called ILTV, which target their upper respiratory tract. The resulting disease, known as infectious laryngotracheitis (ILTV), reduces egg production and can kill up to one-fifth of those infected. “The birds effectively choke to death on blood and mucus,” says Browning. The disease is not known to infect any other animals other than chicken and chicken-like birds.

To combat ILTV, farmers vaccinate their chickens with attenuated herpesviruses that can still infect and replicate but do not lead to disease. Australia has used two vaccines, which are produced by Pfizer and called SA2 and A20. In 2006, however, the country purchased a new vaccine from European company Intervet called Serva. Two years later, new strains of ILTV, called class 8 and 9, appeared. They are just as deadly as other strains. “But they seem to be dominating over the strains that were reported prior to 2007,” says Browning.

Because the new strains appeared shortly after the European vaccine was introduced, scientists thought that the new vaccine strain might have reverted back to a disease-causing form. But when the researchers sequenced the genomes of the two new strains and the three vaccine strains, they found that the new viruses were actually stitched together from the European and Australian vaccines. Although it is not clear what mutations keep the vaccine strains from causing disease in the first place, they were probably lost when the viruses recombined, says Browning, whose team reports its findings online today in Science.

“This is quite possible but a bit surprising since it would imply that both vaccines have gone into the same animal, which would be required for recombination to occur,” Paul Farrell, a virologist at Imperial College London, wrote in a statement released by the Science Media Centre. Farmers do not deliberately vaccinate with both vaccines, Browning agrees. But the SA2 strain might have spread into an unvaccinated population that was later vaccinated with the Serva strain, he suggests.

The data for the recombination is “convincing,” says Walter Fuchs, who heads the National Reference Laboratory for Infectious Laryngotracheitis of Poultry on the island of Riems in Germany. The combination of vaccine strains to form a new virus is “a problem that needs to be taken seriously,” adds Thomas Mettenleiter, head of the Federal Research Institute for Animal Health also on Riems. Only well-characterized live vaccines, rendered harmless by mutations in the same or overlapping regions, should be used in order to minimize the risk of recombination to a new virulent strain, he argues.

Live-attenuated vaccines are also used in humans, but a lot less than in poultry, and their sequence is usually known. “This is not a panic-button on vaccines,” says Browning. And Farrell stresses vaccines have been one of the great success stories of medicine. “The type of important technicality raised in this article should not be allowed to detract from the enormous health benefit generally provided by vaccines,” he wrote.

U.S. healthcare by the numbers / Reuters

According to Reuters, the US ranks close to the bottom on a number of healthcare indices, compared to   the 33 other countries in the OECD (Organization for Economic Cooperation and Development).  Of course, the US ranks at the top in terms of cost:  17.9% of GDP is spent on healthcare in the US.

There is one other category in which the US ranks first:  90 percent of U.S. adults aged 15 and older describe themselves as being in good health versus an OECD average of 69.1 percent of citizens in the other OECD countries who said they were in good health.  Got that?

For infant mortality, we rank 31st.  For life expectancy, we rank 27th.  For both doctors per capita, and doctor visits per capita, we rank 29th.  For hospital beds per capita, we rank 30th.  For percentage of people with health coverage, we rank 31st.  Only Mexico has a higher rate of diabetes than the US, and no country has more obesity than we do.

But Americans think they have the best health, and think they have the best healthcare in the world.

This paradox is why the system keeps getting worse (by the indices cited) as it gets more expensive.  Go figure.

Fined $3 Billion for Illegal Sales and Marketing of Drugs...but it's just the cost of doing business / NY Times

From the NY Times:

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs...

No individuals have been charged in any of the cases. Even so, the Justice Department contends the prosecutions are well worth the effort — reaping more than $15 in recoveries for every $1 it spends, by one estimate.

But critics argue that even large fines are not enough to deter drug companies from unlawful behavior. Only when prosecutors single out individual executives for punishment, they say, will practices begin to change.

“What we’re learning is that money doesn’t deter corporate malfeasance,” said Eliot Spitzer, who, as New York’s attorney general, sued GlaxoSmithKline in 2004 over similar accusations involving Paxil. “The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.”...

Despite the large amount, $3 billion represents only a portion of what Glaxo made on the drugs. Avandia, for example, racked up $10.4 billion in sales, Paxil brought in $11.6 billion, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a data group that consults for drugmakers.

“So a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business,” Mr. Burns said.

Mr. Burns and others have said that to institute real change, executives must be prosecuted criminally or barred from participating in the Medicare and Medicaid programs, an action known as “exclusion.”

This has occurred in only a handful of cases, and rarely in a case involving a major pharmaceutical company. In 2011, four executives of the medical device company Synthes were sentenced to less than a year in prison for conducting clinical trials that were not authorized by the Food and Drug Administration.

That same year, the former chief executive of K.V. Pharmaceutical was sentenced to 30 days in jail and fined $1 million for selling misbranded morphine tablets. The previous year, the Department of Health and Human Services excluded him from doing business with the federal government...

Cellphone carriers responded to 1.3 MILLION requests from law enforcement agencies in the US last year / NY Times

From Eric Lichtblau at the NY Times:

WASHINGTON — In the first public accounting of its kind, cellphone carriers reported that they responded to a startling 1.3 million demands for subscriber information last year from law enforcement agencies seeking text messages, caller locations and other information in the course of investigations.

The cellphone carriers’ reports, which come in response to a Congressional inquiry, document an explosion in cellphone surveillance in the last five years, with the companies turning over records thousands of times a day in response to police emergencies, court orders, law enforcement subpoenas and other requests.

The reports also reveal a sometimes uneasy partnership with law enforcement agencies, with the carriers frequently rejecting demands that they considered legally questionable or unjustified. At least one carrier even referred some inappropriate requests to the F.B.I.

The information represents the first time data have been collected nationally on the frequency of cell surveillance by law enforcement. The volume of the requests reported by the carriers — which most likely involve several million subscribers — surprised even some officials who have closely followed the growth of cell surveillance.

“I never expected it to be this massive,” said Representative Edward J. Markey, a Massachusetts Democrat who requested the reports from nine carriers, including AT&T, Sprint, T-Mobile and Verizon, in response to an article in April in The New York Times on law enforcement’s expanded use of cell tracking. Mr. Markey, who is the co-chairman of the Bipartisan Congressional Privacy Caucus, made the carriers’ responses available to The Times...

With the rapid expansion of cell surveillance have come rising concerns — including among carriers — about what legal safeguards are in place to balance law enforcement agencies’ needs for quick data against the privacy rights of consumers.

Legal conflicts between those competing needs have flared before, but usually on national security matters. In 2006, phone companies that cooperated in the Bush administration’s secret program of eavesdropping on suspicious international communications without court warrants were sued, and ultimately were given immunity by Congress with the backing of the courts. The next year, the F.B.I. was widely criticized for improperly using emergency letters to the phone companies to gather records on thousands of phone numbers in counterterrorism investigations that did not involve emergencies.

Under federal law, the carriers said they generally required a search warrant, a court order or a formal subpoena to release information about a subscriber. But in cases that law enforcement officials deem an emergency, a less formal request is often enough. Moreover, rapid technological changes in cellphones have blurred the lines on what is legally required to get data — particularly the use of GPS systems to identify the location of phones...

The biodefender that cries wolf / LA Times

David Willman does another deft job with the story of BioWatch, hopefully in time to influence the upcoming purchase of BioWatch's next generation of detectors.  None have yet worked as billed. 

The "detectors" are simply air samplers:  filters attached to vacuum tubes.  The filters have to be collected, then tested elsewhere using PCR devices specific to each microbial pathogen of concern.  The PCR (polymerase chain reaction) devices theoretically ought to be specific enough to  distinguish deadly germs from related, but benign relatives. 

The fact that they don't, suggests that the idea behind the system is flawed.  Why waste billions on the next gen device, when the theoretical underpinning of BioWatch is a failure?

Colorado has experienced multiple false alarms. Willman interviewed Colorado's former chief medical officer of the Department of Public Health:

"I can't find anyone in my peer group who believes in BioWatch," said Dr. Ned Calonge, chief medical officer for the Colorado Department of Public Health and Environment from 2002 to 2010.  "The only times it goes off, it's wrong. I just think it's a colossal waste of money.  It's a stupid program."

Previous reports on the BioWatch program by the Institute of Medicine, the DHS Inspector General and GAO couched their criticisms in understatement, but said the same things as Willman.

However, the BioWatch boondoggle does allow our leaders to claim they are protecting us:  and that may be enough to continue the program.