Flu Shots May Not Protect the Elderly or the Very Young / Scientific American

From yesterday's Scientific American:

Despite government recommendations, there is little evidence that flu vaccines help individuals older than 65 or younger than two.

Every year around this time, 120 million Americans roll up their sleeves to get their annual flu shots. Since 2010, the U.S. Centers for Disease Control and Prevention has recommended yearly jabs for every healthy American over the age of six months. The goal is to curb the spread of infection and minimize the risk for potentially dangerous complications such as pneumonia, particularly among the elderly and the very young. But science on the vaccine’s efficacy is scant among those two vulnerable groups. And although healthy adults do get some protection, it may not be as robust as they expect.

One oft-cited claim, based on several large meta-analyses published more than a decade ago, is that seasonal flu shots cut the risk of winter death among older people by half. But the research behind that claim has been largely debunked. A 2005 study published in the Archives of Internal Medicine noted that influenza only causes about 5 percent of all excess winter deaths among the elderly—which works out to one death from flu per 1,000 older people each season—so it’s impossible for the shot to prevent half of all their winter deaths. The following year, a study reported that as vaccine coverage increased among the elderly in Italy in the late 1980s, there was no corresponding drop in excess deaths. In another 2006 paper, Lisa Jackson, an infectious disease epidemiologist at the Group Health Research Institute in Seattle, and her colleagues showed that although vaccinated seniors were 44 percent less likely to die during flu season than unvaccinated seniors were, the vaccinated ones were also 61 percent less likely to die before flu season even started. “Naturally, you would not expect the vaccine to work before the thing it protects against is going around,” says Lone Simonsen, a research professor in global health at George Washington University and a co-author of the 2005 study in the Archives of Internal Medicine.

Researchers now attribute these odd findings to a “healthy user” effect. People who don’t get vaccinated often “are the most frail or [those] whose health has gone down dramatically in the last few months,” explains CDC epidemiologist David Shay. People who choose to get flu shots, in other words, are already healthier and therefore the least likely to die.

So how much does the vaccine truly help older people? In January 2012, Michael Osterholm, an epidemiologist at the University of Minnesota’s Center for Infectious Disease Research and Policy, and his colleagues published a meta-analysis in The Lancet Infectious Diseases that analyzed the results of all randomized controlled clinical trials conducted between 1967 and 2011 on the effects of flu shots. It found that there have been no clinical trials evaluating the effects of the traditional flu vaccine in the elderly. The only vaccine shown to protect against infection or death in older adults, it said, is the live-attenuated vaccine—an inhalable vaccine that contains a live, modified version of the virus—which is not approved in the U.S. for adults over age 50.

The traditional vaccine may not work so well in older people because of an idea known as immune senescence, which posits that as people age, their immune systems weaken, resulting in poor vaccine response, especially to inactivated strains. Although the U.S. Food and Drug Administration licensed a high-dose vaccine for seniors in 2009 that could theoretically overcome this problem, no studies have yet been published on how effective it is. “The higher dose produces a higher level of antibodies, but we don’t really know what that correlates to,” says Jackson. A 2010 systematic review published by the Cochrane Collaboration, an independent, nonprofit organization that promotes evidence-based medicine, concluded that “until such time as the role of vaccines for preventing influenza in the elderly is clarified, more comprehensive and effective strategies for the control of acute respiratory infections should be implemented.”

The dearth of controlled research on seniors stems in part from the fact that the U.S government considers such clinical trials unethical. Based on an idea known as clinical equipoise, scientists can’t test, in a randomized controlled trial, a treatment that the larger medical community already considers to be effective, because doing so would involve denying treatment to half of the participants, potentially putting them at risk. “We’re in a difficult spot,” Shay says—since the CDC already recommends flu shots to seniors, the agency can’t suddenly turn around and ask them to participate in a clinical trial that might deny them the standard of care.   

(But there are plenty of countries whose governments do not recommend yearly flu shots, and their populations could be tested, if CDC truly wanted to learn the answer--Nass)

What about kids? In 2010, the U.S. Advisory Committee on Immunization Practices began recommending flu vaccination for all healthy children older than six months, an expansion that they claimed was “supported by evidence that annual influenza vaccination is a safe and effective preventive health action with potential benefit in all age groups.” Yet a July 2012 Cochrane Collaborationsystematic review concluded that for kids under the age of two, the currently licensed vaccines “are not significantly more efficacious than placebo.” The review highlighted a single small study conducted on children under two—the only controlled study that has evaluated the efficacy of the shot currently licensed for young kids—which found, overall, that vaccines provided no statistically significant protection over the course of two flu seasons. “One season, the vaccine did something to prevent some symptoms, but in the second, nothing,” says co-author Tom Jefferson, an epidemiologist with the Cochrane group. In kids older than 2, however, flu vaccines do seem to work; according to the Cochrane analysis, the shot reduces the absolute risk that a child will catch the flu by about 3.6 percent, whereas the live (inhaled) vaccine reduces the absolute risk by about 17 percent.

In healthy adults under the age of 65, flu vaccines work, too. A 2010 Cochrane review, also co-authored by Jefferson, estimated that during “good” vaccine years—when the vaccines match the circulating viral strain well, which Jefferson says happens about half the time—the vaccine reduces the relative risk that an adult under 65 will catch the flu by about 75 percent. In absolute terms, however, this means adults have about a four percent chance of catching the flu if they don’t get the vaccine and about a one percent chance if they do. Shay notes that while this estimate is reasonable, some flu seasons are worse than others, so the risk may be higher than 4 percent in some years (and some people) and lower than 4 percent in others. (And of course, the vaccine won’t protect against the nearly 200 viruses that cause flu-like symptoms but aren’t actually the flu.) Although scientists generally believe that the flu vaccine slows the spread of the virus through communities, there are no data showing that this is true, because “those studies are very difficult to do,” Shay explains.   

(Again, one can do viral cultures and test this assertion, but it seems CDC does not wish to put it to the test, as this is one justification for vaccination that is not disputed by the data, since there are no data.--Nass) 

So should people still dutifully line up for their flu shots? Older kids and healthy adults do get some protection from them; just perhaps not as much as they want or expect. But for seniors and toddlers, there may never be a clear answer to this question, particularly because the U.S. government is unlikely to conduct additional clinical trials. On Monday, Osterholm and a group of five other scientists at the University of Minnesota’s Center for Infectious Disease Research and Policy published a report highlighting the need for better alternatives. Although the current options may—for most people—be better than nothing, “we can no longer accept the status quo,” they wrote. “The perception that current vaccines are already highly effective in preventing influenza is a major barrier to pursuing game-changing alternatives.”

New report questions science behind flu vaccine efficacy and use policy / Calgary Post

The entire article from the Calgary Post is below, as it is important.  The article cites well known flu experts Danuta Skowronsky and Michael Osterholm (who is first author of a report that forms the basis of the piece) acknowledging the vaccine just doesn't work all that well as has been claimed.  The report "... suggests that the belief that universal vaccination for flu would be useful and desirable, rather than solid scientific evidence, was what drove decisions to recommend flu shots for all in the U.S."

 

 

A nurse injects a patient with a H1N1 vaccine during a flu shot program in Calgary on Oct. 26, 2009. A new report says flu vaccine is not as effective as public health messaging suggests and new and better vaccines are needed.

Photograph by: Jeff McIntosh , THE CANADIAN PRESS

Flu vaccine is not as effective as public health messaging traditionally has claimed, says a new report that suggests overselling of flu shots is getting in the way of developing more effective and longer lasting vaccines.

Existing flu shots offer moderate protection some years and less in others and in general are "sub-optimal," according to the report, from public health experts at the Center for Infectious Diseases Research and Policy at the University of Minnesota.

"Our current influenza vaccines work for some of the people some of the time. And we clearly need vaccines that work for most of the people most of the time," Dr. Michael Osterholm, director of the center, said in an interview Monday.

While the report strongly urges the development of "game-changing" vaccines, it says in the meantime people should use the tool that exists.

"We recommend you continue to get your flu shot. It's the best protection we have. But it's not enough," Osterholm said.

He is first author of the report, which is the product of a three-year investigation into the science supporting flu vaccine efficacy and safety and the decision-making processes that led to the U.S. policy to recommend all Americans get a flu shot every year.

The project that led to the report was called the CIDRAP Comprehensive Influenza Vaccine Initiative, and it involved mining more than 12,000 documents, articles and meeting transcripts as well as more than 5,700 peer-reviewed vaccine studies published from 1936 through April 2012.

The work was funded in part by a grant from the Alfred P. Sloan Foundation.

Interestingly, where five years ago claims like these likely would have been denounced as public health heresy, this report, in the main, is receiving a much warmer welcome.

In recent years studies by a variety of research groups — including in Canada — have shown that the long-quoted claims that flu shots offered 70 to 90 per cent protection against influenza have been off the mark.

Somewhere in the order of 50 to 60 per cent, in healthy adults, is more accurate, the newer studies suggest. Efficacy rates are lower in the elderly or people in poor health.

The report suggests that the higher numbers came from old studies done on vaccines that were not formulated the way current shots are. It also suggests that the belief that universal vaccination for flu would be useful and desirable, rather than solid scientific evidence, was what drove decisions to recommend flu shots for all in the U.S. (The study did not look at decisions made in Canada or elsewhere.)

Even the vaccine used in the U.S. during the 2009 pandemic — where there was a perfect match between the virus in the vaccine and the strain infecting people — didn't offer better protection. Studies cited in the report pegged the U.S. vaccine's effectiveness at 56 per cent.

Dr. Danuta Skowronski, an influenza expert at the B.C. Centre for Disease Control, is involved in flu vaccine efficacy studies that have been conducted annually in Canada since 2004. She said the findings of those studies support the arguments made in the CIDRAP report.

"Over that period, seldom has the seasonal vaccine effectiveness exceeded 60 per cent," Skowronski said.

The world spends enormous sums trying to vaccinate people against influenza every year. In Canada alone, Skowronski said, spending on flu vaccine programs likely exceed $100 million per year.

"We need a better vaccine," she said. "And investing in improved vaccine options may be more rewarding than expanding the use of the current vaccine to greater segments of the population."

A key argument of the report is the fact that the current vaccine that offers moderate protection is actually getting in the way of developing long-lasting flu vaccines that offer more effective protection — vaccines, for example, that might require a shot every five or 10 years. Currently flu shots are reformulated every year to try to keep up with the evolution of flu viruses.

"I don't want to oversimplify this dilemma of what do you do now?" said Dr. John Treanor, an expert in flu vaccines and chief of the infectious diseases division at the University of Rochester (N.Y.) Medical Center.

"How do you at the one time promote the vaccine that you have and at the same time create space to make new vaccines? I think that's a very difficult thing to do."

In recent years pharmaceutical companies — spurred in large part by massive funding from the U.S. government — have been working on ways to improve existing vaccines. But tweaking the current vaccines won't solve the problem, the report says, insisting that what is needed are vaccines that target different parts of the flu virus than the current ones do.

The enormous cost of developing such vaccines means the only way they will come into existence is if governments support the work, the report says, noting that producing a single new flu vaccine could take 15 years of work and cost a company upwards of US$1 billion.

It called on the U.S. government to play the lead role in pushing this agenda, saying the World Health Organization is not in a position to do so.

And there is little incentive for industry to take the risk to develop wholly new flu vaccine approaches, the report says.

Even though a flu shot is a relatively inexpensive vaccine, manufacturers sell hundreds of millions of doses of them a year. In fact, the report notes that the global market for flu vaccine is estimated at US$2.8 billion — a decent chunk of the estimated US$20 billion annual market for all vaccines combined.

Treanor said in his estimation, a major advance in flu vaccines is not around the corner.

"I think we're very far away from the game-changing vaccine right now."

Readmore:http://www.calgaryherald.com/health/report+questions+science+behind+vaccine+efficacy+policy/7391714/story.html#ixzz29mXLGqwx

Why is the new swine flu newsworthy?/ CDC

It seems we have been hearing about the "new" swine flu over and over again.  Why should we care?

Only 290 cases throughout the US have been identified this season.  There have been either no or next-to-no cases of human to human transmission.  CDC thinks there may have been 3 people (1%) who caught the illness from a household contact.  The other people affected (99%) caught it from pigs. 

Hardly any of the cases (a total of 15) were bad enough to require hospitalization.  There has only been one death, in a woman with multiple other medical conditions, which occurred last week.

I went to the local fair Monday and there were plenty of pigs, as well as other farm animals.  There were also posters advising handwashing and many (new) alcohol rub handwashing stations.  That was the appropriate response to this swine flu.
This strain of swine flu (H3N2) was first identified last year.  Well, new strains are the rule, not the exception.  It is not especially virulent.  It doesn't transmit well to humans.  Most people affected have been children, suggesting that older people are likely to have some immunity from prior flu seasons. 

More to the point, this year's flu shot will not provide immunity for the new strain.

Sure, the strain might mutate and spread better in future.  It might become more virulent.  It might start affecting more adults.  And pigs might fly.

Last winter, the US had the mildest flu season ever recorded. 

Is CDC flummoxed by last year's flu season that never was?  Is CDC desperate to keep flu, and flu vaccine, in the news?  Why is its response disproportionate to the disease's impact?

Is CDC using a mild new flu, that is not even prevented by vaccination, to drum up a flu frenzy so people get vaccinated?

I'd love another explanation for the frequent CDC press releases, full of sound and fury, signifying nothing. Can you think of any?

2,000 medical staff refuse H1N1 vaccine in Pune / Times of India

Not a single doctor or paramedic of the 2,000 working at public hospitals in Pune, India have accepted free flu shots offered to them by state government, according to the Times of India.

Yet hospitals in the US increasingly force their employees to receive these inoculations, although they have not been shown to reduce infections or death in staff members or patients.  And new data increasingly show that you are actually more likely to become clinically ill with flu if you have received a flu vaccine in a prior, recent year.  I have blogged abstracts on this subject before.

PUNE: The H1N1 virus is still active, but not all paramedics and doctors treating infected patients at PMC-run hospitals have got themselves vaccinated.
Barring doctors involved in swine flu patient care at designated private hospitals, the front-line medical staff at corporation hospitals and dispensaries have turned their backs to the injectible vaccine given free of cost by the Union government.
The city has reported over 70 positive cases and four deaths in the month of August so far. On Thursday, five more tested positive. The condition of a 29-year-old man is critical.
"It is true that the vaccine has been made available for our medical staff, but there is reluctance to get vaccinated. None of them took the shot, but we are sensitising them to get vaccinated to shield themselves from the infection," said S T Pardeshi, PMC medical officer of health (MoH).
The PMC received 3,050 vaccine doses for its 2,000 front-line medical staff including doctors, paramedics etc and 1,000 medical staff involved in swine flu patient-care at private hospitals designated as swine flu treatment centres in Pune. "Barring 1,182 doctors in private designated hospitals, none of the medical staff at Naidu and other PMC-run hospitals and dispensaries have taken the vaccine," said another civic official. Over 1,800 doses are lying unused.The resurgence of swine flu infection in Pune, Mumbai and nearby areas in the state during summer this year had prompted the Union Health Ministry to procure vaccines for medical staff involved in management of H1N1 infection cases in Maharashtra. The ministry's Emergency Medical Relief (EMR) department had asked state officials to furnish exact requirement of the doses for the staff a few days ago. Accordingly, the doses were made available by end of April.
"The objective was to vaccinate the front-line health staff before monsoon since rains provide conducive setting for proliferation of influenza viruses," said state epidemiologist Pradip Awate, who is also the state surveillance officer.
During the previous outbreak, the Union health ministry had to call back unused doses of imported vaccines following poor response from doctors and paramedical staff. In July 2010, when the infection was at its peak across the state, only 2,055 of the 34,300 medical staff in the state involved in treatment of H1N1 cases had taken the vaccine. "We can only advise the medical staff to take the vaccine, not force them," said officials.

Researchers Hack Brainwaves to Reveal PIN Numbers, Other Personal Data / Wired

 Oops! Copyright Cops Return Seized RojaDirecta Domain Names – 19 Months Later

From Wired:  So you thought your passwords were memorized and totally secure?  Think again.  Do you really want to bank online?  These discoveries and devices are gamechangers, and the game is life as we know it.

•  | Edit

The “developer edition” of the Emotiv Epoc headset — if you think you can handle it.  

Don’t you dare even think about your banking account password when you slap on those fancy new brainwave headsets.

Or at least that seems to be the lesson of a new study which found that sensitive personal information, such as PIN numbers and credit card data, can be gleaned from the brainwave data of users wearing popular consumer-grade EEG headsets.

A team of security researchers from Oxford, UC Berkeley, and the University of Geneva say that they were able to deduce digits of PIN numbers, birth months, areas of residence and other personal information by presenting 30 headset-wearing subjects with images of ATM machines, debit cards, maps, people, and random numbers in a series of experiments. The paper, titled “On the Feasibility of Side-Channel Attacks with Brain Computer Interfaces,” represents the first major attempt to uncover potential security risks in the use of the headsets.

“The correct answer was found by the first guess in 20% of the cases for the experiment with the PIN, the debit cards, people, and the ATM machine,” write the researchers. “The location was exactly guessed for 30% of users, month of birth for almost 60% and the bank based on the ATM machines for almost 30%.”

To detect the first digit of the PIN, researchers presented the subjects with numbers from 0 to 9, flashing on the screen in random order, one by one. Each number was repeated 16 times, over a total duration of 90 seconds. The subjects’ brainwaves were monitored for telltale peaks that would rat them out

The EEG headsets, made by companies such as Emotiv Systems and NeuroSky, have become increasingly popular for gaming and other applications. For the study, the researchers used the Emotiv Epoc Neuroheadset, which retails for $299...

Will big box medicine actually lower costs? There are valid grounds for doubt.

From the article "Reform Driving Physicians Out of Private Practice to Reduce Costs" a few issues are raised about rapid and dramatic changes occurring in health care, about which consumers have little knowledge.  Health care conglomerates are being forcibly created due to the new payment structure, which can only increase costs considerably in the short term.  And increase doctor dissatisfaction.  I haven't seen patients any happier.  And fewer and fewer can pay for their insurance.  Author Thomas Frank suggested in Harper's that Obamacare is derived in part from a Heritage Foundation proposal for health care.  Hello?

... When Congress passed the Affordable Care Act (ACA) in an attempt to redirect the unsustainable trajectory of our $2.9 trillion, extraordinarily complex healthcare system, it did so with about 2,600 pages of potential progenitors of the Butterfly Effect.

The casualties of the first flutters wrote large are being seen already. They are doctors being driven out of private practice and into the safe refuge of employment by hospitals, large clinics, and integrated health systems. These consolidated systems, with near monopolies in many geographic regions, will be powerful enough to demand higher rates and new fees from payers. As a countermeasure, government reformers are pushing accountable care organizations, with bundled bills, budgetary caps, and capitated rates, shifting risk to closed systems of physicians and hospitals.

Will big box medicine actually lower costs? There are valid grounds for doubt. If and how long the federal government can afford to keep the new system afloat with cash as it conversely heaps on mountains of new regulations and unfunded mandates lengthens the odds of success considerably.

Exacerbating the entire situation is the present public health concern of physician shortages building to crisis proportions as so starkly outlined by Annie Lowrey and Robert Pear in their July 28, 2012 New York Times article, “Doctor Shortage Likely to Worsen With Health Law.”

Putting physicians who have invested a decade or more in intensive training with six figure school loans out of business and into a big box lab coat is far removed from putting a general store owner out of business and into a big box retail vest. The level of dissatisfaction among physicians is already profound, and worsening. Of greater concern — they have choices other than clinical medicine and resources to pursue them.

So, the question is:  Is driving a systemically distressed, contracting, dissatisfied and undercompensated physician sector to be forcibly absorbed by a traditional antagonist, but symbiotic hospital sector on the edge of distress itself and binding them together with miles of red tape and questionably reachable incentives going to reduce costs? ...

Same Doctor Visit, Double the Cost / WSJ

Just another example of the crazy billing environment for medicine in the US.  From the WSJ:

"After David Hubbard underwent a routine echocardiogram at his cardiologist's office last year, he was surprised to learn that the heart scan cost his insurer $1,605. That was more than four times the $373 it paid when the 61-year-old optometrist from Reno, Nev., had the same procedure at the same office just six months earlier.

"Nothing had changed, it was the same equipment, the same room," said Dr. Hubbard, who has a high-deductible health plan and had to pay about $1,000 of the larger bill out of his own pocket. "I was very upset." 

But something had changed: his cardiologist's practice had been bought by Renown Health, a local hospital system. Dr. Hubbard was caught up in a structural shift that is sweeping through health care in the U.S.—hospitals are increasingly acquiring private physician practices.

 Hospitals say the acquisitions will make health care more efficient. But the phenomenon, in some cases, also is having another effect: higher prices.

As physicians are subsumed into hospital systems, they can get paid for services at the systems' rates, which are typically more generous than what insurers pay independent doctors. What's more, some services that physicians previously performed at independent facilities, such as imaging scans, may start to be billed as hospital outpatient procedures, sometimes more than doubling the cost...

Medicare pays substantially more for certain services if they are performed at hospital facilities. A 15-minute doctor visit, for instance, cost the program about $70 last year at a free-standing practice, but the same visit ran about $124 if it was billed as hospital-outpatient, according to the Medicare Payment Advisory Commission... 

Every time a physician practice ties up with a hospital system, "there is a tangible, or sometimes really, really high increase in what we pay doctors," said Juan Davila, Blue Shield's senior vice president for network management... 

Who's Watching the NSA Watchers? / NY Times

I was glad to see this piece, which explains that public horror at "Total Information Awareness" caused it to be cancelled in 2003--only to have a much grander, insidious and dangerous NSA program grow up in its place.

The current program lacks two critical pieces, including a way to track and record who accesses data and what they see.  Meanwhile, a million square foot repository is being built to contain all the communications being captured and analyzed.

This Op/Ed's alternate title is "Giving in to the Surveillance State:"

In March 2002, John M. Poindexter, a former national security adviser to President Ronald Reagan, sat down with Gen. Michael V. Hayden, the director of the National Security Agency. Mr. Poindexter sketched out a new Pentagon program called Total Information Awareness, that proposed to scan the world’s electronic information — including phone calls, e-mails and financial and travel records — looking for transactions associated with terrorist plots. The N.S.A., the government’s chief eavesdropper, routinely collected and analyzed such signals, so Mr. Poindexter thought the agency was an obvious place to test his ideas.

He never had much of a chance. When T.I.A.’s existence became public, it was denounced as the height of post-9/11 excess and ridiculed for its creepy name. Mr. Poindexter’s notorious role in the Iran-contra affair became a central focus of the debate. He resigned from government, and T.I.A. was dismantled in 2003.

But what Mr. Poindexter didn’t know was that the N.S.A. was already pursuing its own version of the program, and on a scale that he had only imagined. A decade later, the legacy of T.I.A. is quietly thriving at the N.S.A. It is more pervasive than most people think, and it operates with little accountability or restraint...

What’s missing, however, is a reliable way of keeping track of who sees what, and who watches whom. After T.I.A. was officially shut down in 2003, the N.S.A. adopted many of Mr. Poindexter’s ideas except for two: an application that would “anonymize” data, so that information could be linked to a person only through a court order; and a set of audit logs, which would keep track of whether innocent Americans’ communications were getting caught in a digital net...

The Widespread Problem of Doctor Burnout

Pauline Chen, MD blogs at the NY Times about what it feels like to be a doctor today.  Here she discusses a new survey of 7,000 practicing doctors, 48% of whom experienced at least one symptom of "burnout."   Excerpts from her article follow:

...Research over the last 10 years has shown that burnout - the particular constellation of emotional exhaustion, detachment and a low sense of accomplishment - is widespread among medical students and doctors-in-training. Nearly half of these aspiring doctors end up becoming burned out over the course of their schooling, quickly losing their sense of empathy for others and succumbing to unprofessional behavior like lying and cheating.Now, in what is the first study of burnout among fully trained doctors from a wide range of specialties, it appears that the young are not the only ones who are vulnerable. Doctors who have been practicing anywhere from a year to several decades are just as susceptible to becoming burned out as students and trainees. And the implications of their burnout -- unlike that of their younger counterparts, who are often under supervision -- may be more devastating and immediate.
Analyzing questionnaires sent to more than 7,000 doctors, researchers found that almost half complained of being emotionally exhausted, feeling detached from their patients and work or suffering from a low sense of accomplishment. The researchers then compared the doctors' responses with those of nearly 3,500 people working in other fields and found that even after adjusting for variables like gender, age, number of hours worked and amount of education, the doctors were still more likely to suffer from burnout.
"We're not talking about a few individuals who are disorganized or not functioning well under pressure; we're talking about one out of every two doctors who have already survived rigorous training," said Dr. Tait D. Shanafelt, the lead author of the study and a professor of medicine at the Mayo Clinic in Rochester, Minn. "These numbers speak to bigger problems in the larger health care environment."
The doctors' burnout appeared to have little to do with hours worked or even the ability to balance personal life with work. Instead, the only factor predictive of a higher risk was practicing a specialty that offered front-line access to care. More than half of the doctors in family medicine, emergency medicine and general internal medicine experienced some form of burnout.
The study casts a grim light on what it is like to practice medicine in the current health care system. A significant proportion of doctors feel trapped, thwarted by the limited time they are allowed to spend with patients, stymied by the ever-changing rules set by insurers and other payers on what they can prescribe or offer as treatment and frustrated by the fact that any gains in efficiency offered by electronic medical records are so soon offset by numerous, newly devised administrative tasks that must also be completed on the computer....

Commission members and experts discussion a pedi anthrax trial

Interesting comments were made at the last meeting of the Presidential Commission for the Study of Bioethical Issues, reported on the Commission blog.  They include the following:

Anita Allen, J.D., Ph.D., Commission member and Henry R. Silverman Professor of Law at the University of Pennsylvania: “Military families are subject to extraordinary pressures on the need to conform and obey; military children are disproportionately separated from their families… Maybe military families are not the best place to go for experimentation.”

Alexander G. Garza, M.D., M.P.H., Commission member and Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security: “After having received the anthrax and smallpox vaccine I can still walk and chew gum at the same time. That being said, we’re talking about two different worlds when we talk about vaccines for influenza and for anthrax. We know a lot about the influenza virus. We don’t know a lot about the anthrax vaccine.”

John Arras, Commission member and Porterfield Professor of Biomedical Ethics at the University of Virginia: “I’m reminded in this context of Hans Jonas’s famous article where he argues that research subjects are best recruited if they are most knowledgeable about the subject and most enthusiastic. We may want to look for volunteers at CDC, NIH, and Ft Detrick.”

David Wendler leads the Vulnerable Populations Unit in the National Institutes of Health Clinical Center’s Bioethics Department.  He led a discussion about minimal risk, and noted, "Essentially, you shouldn’t be doing this on people who don’t understand what you are doing unless you have to.” 

For transcripts relevant to a pediatric anthrax vaccine trial, you can read transcripts from the meeting (Sessions 8-11) here.

Regarding Testing Anthrax Vaccine in Children

Below is my recent letter to the Chair of the Presidential Commission for the Study of Bioethical Issues, preceding the Commission's meeting last week.  The Commission's blog mentions some of what was discussed.  The Commission will report its views to the DHHS Secretary by year's end.

Meryl Nass, MD

Board Certified in Internal Medicine

Mount Desert Island Hospital

10 Wayman Lane

Bar Harbor, Maine 04609

(207) 288-5119

July 28, 2012

Dr. Amy Gutmann

President, University of Pennsylvania

1 College Hall, Room 100

Philadelphia, PA 19104-6380

Dear Dr. Gutmann,

I sent a letter regarding anthrax vaccine to the Presidential Commission for the Study of Bioethical Issues in late January 2012 (copy enclosed).  Because Commission staff did not confirm whether my letter was shared with the Commission members, I am writing you directly. 

With respect to anthrax vaccine and its use as a countermeasure in children, I believe my original letter provided considerable detail.  I would just like to emphasize that the vaccine’s efficacy in humans for inhalation anthrax is unknown.  The efficacy of several anthrax vaccines in clinical trials has depended on the species and strain of animal infected, the strain of anthrax used, and the magnitude of the exposure.  In many animal studies, high antibody levels have failed to protect the animals and prevent deaths.

I am enclosing the consent form for testing anthrax vaccine in children developed by CDC and FDA in 2001, after the anthrax letters. It said, "Anthrax vaccine has not been shown to prevent infection when given to people after exposure to anthrax spores," and “You should not consider the vaccine as treatment for anthrax. The vaccine as given in this program has not been shown to give long term protection against anthrax.”

After holding 5 hearings on the subject of anthrax vaccine in 1999, the House Committee on Government Reform issued a report titled Unproven Force Protection.[i]  Two of its findings were:

• Safety of the vaccine is not being monitored adequately. The program is predisposed to ignore or understate potential safety problems due to reliance on a passive adverse event surveillance system and DOD institutional resistance to associating health effects with the vaccine.

• Efficacy of the vaccine against biological warfare is uncertain. The vaccine was approved for protection against cutaneous (under the skin) infection in an occupational setting, not for use as mass protection against weaponized, aerosolized anthrax. 

Today’s vaccine is the same as that used in 1999 and 2001.  But why use the vaccine anyway?  The immediate medical response to an exposure includes antibiotics and passive immunization with one of several available antibody products, when needed.

There has been concern about late germination of spores, which may remain resident in the lungs for several months.  This concern has led to the recommendation to vaccinate, in addition to providing immediate therapy.  Yet early germination and infection by spores should induce a protective immune response to later spore germination.[ii]  Late germination associated with immune failure can happen, but seems to be a rare event.  Of the 30,000 people offered antibiotics after the anthrax letters, fewer than half completed the prescribed 60 day course, and none developed a late case of anthrax.

I was struck by errors in the presentation of Major General John Parker, M.D. (retired) in May, and by the fact there were no anthrax experts in the room who could answer technical questions germane to the discussion.  It looks like that omission will continue at the August meeting (based on the list of panelists), despite concerns expressed by you at the last meeting regarding the need for clarification of facts regarding anthrax vaccine science. 

General Parker deflected your question of whether those who were familiar with the vaccine, and urged its use, would vaccinate their own children.  He answered that some military members wanted their children to receive the same vaccine protection they had.  Yet if those soldiers were informed the vaccine had not proven protective in humans, would they still want their children vaccinated?  And what of the researchers and government administrators who spoke in favor of a trial in children?  Will they offer their children or grandchildren for testing?

It is difficult to convey the degree of effort expended over many years to promote anthrax immunization, which has created a smokescreen around anthrax vaccine science.  For those unfamiliar with the details, it appears unbelievable.  I can best convey it by using a metaphor:  the BioWatch program.

Pulitzer prize-winning journalist David Willman wrote a recent article on the failures of BioWatch, a federal program employing sensors to identify the offensive use of microorganisms, in Philadelphia and other large cities: 

http://articles.latimes.com/2012/jul/07/nation/la-na-biowatch-20120708

No matter how much evidence Willman unearthed about the program, official spokespersons kept repeating their mantra about BioWatch’s effectiveness.  Willman’s article shows how the system works to protect favored programs in Washington, regardless of their value. The amount of money involved is phenomenal.  The anthrax vaccine manufacturer has received over 2 billion dollars for anthrax vaccine, after buying the factory for 18 million dollars from the state of Michigan in 1998.

It appears that the focus of the August meeting of the Commission will be on countermeasures in general, rather than anthrax vaccine in particular. Public comments on the ethical implications of pediatric countermeasures research have been solicited.

I’d like to say several things about this.  First, unlike most therapeutic agents, anthrax vaccine has pressing safety and efficacy questions.  Anthrax vaccine should therefore be considered individually by the Commission, with its unique issues in mind, rather than as one of many possible countermeasures.

Next, many countermeasures designed to respond to biological, chemical and radiological agents have been given a manufacturer waiver of liability through the Public Readiness and Emergency Preparedness (PREP) Act. 

http://www.phe.gov/preparedness/legal/prepact/Pages/default.aspx

The result is that they may not have been developed or tested with the same rigor as other medical products. Yet reliable testing in adults for efficacy and safety should precede testing of such products in children, if at all possible.  Thus the decision to test countermeasures that have liability waivers, including anthrax vaccine, in children, should require a higher level of evidence derived from adults, compared with testing products not given a liability waiver. 

Finally, the press release for this meeting stated, "The Commission is examining whether the U.S. government should do research that could cause harm to protect children from high consequence events with a low or unknown likelihood of happening."  The low/unknown likelihood of such an event would suggest such research cannot meet the requirement of 45 CFR 46.407 for approvable pediatric

research:  which is to present “a reasonable opportunity to further the … alleviation of a serious problem affecting the health and welfare of children.”

Some panelists at the May Commission meeting alluded to the need to balance risk and benefit as a justification to perform pediatric countermeasures research.  45 CFR 46.407 does not call for balancing benefits and risks.  Instead, it provides a nonporous barrier against potential child subject endangerment, designed with child protection as the sole consideration, regardless of any potential benefits for children or society that may be invoked.

Thank you very much for taking the time to serve as Chair of the Commission, and for taking these concerns into consideration.

Sincerely yours,

Meryl Nass, M.D.

Cc:  Presidential Commission for the Study of Bioethical Issues

---

[i] http://www.fas.org/spp/starwars/program/news00/anthrax1.pdf   (page 4)

[ii] Weiss S, Kobiler D, Levy Haim et al. Antibiotics Cure Anthrax in Animal Models. Antimicrobial Agents and Chemotherapy 2011; 55(4): 1533-42.

Health is More than Influenza / WHO Bulletin 2011

I have to give the WHO editors kudos for being brave enough to commission commentaries on WHO's pandemic planning.


Peter Doshi wrote about WHO's waffling over the definition of pandemic, which morphed into a meaningless definition that allowed even the common cold to be called a pandemic, since severity was missing from the definition.


Bonneux and Van Damme minced no words in their commentary:

The repeated pandemic health scares caused by an avian H5N1 and a new A(H1N1) human influenza virus are part of the culture of fear.^1–3 Worst-case thinking replaced balanced risk assessment. Worst-case thinking is motivated by the belief that the danger we face is so overwhelmingly catastrophic that we must act immediately. Rather than wait for information, we need a pre-emptive strike. But if resources buy lives, wasting resources wastes lives. The precautionary stocking of largely useless antivirals and the irrational vaccination policies against an unusually benign H1N1 virus wasted many billions of euros and eroded the trust of the public in health officials.^4–6 The pandemic policy was never informed by evidence, but by fear of worst-case scenarios.

In both pandemics of fear, the exaggerated claims of a severe public health threat stemmed primarily from disease advocacy by influenza experts. In the highly competitive market of health governance, the struggle for attention, budgets and grants is fierce. The pharmaceutical industry and the media only reacted to this welcome boon. We therefore need fewer, not more “pandemic preparedness” plans or definitions. Vertical influenza planning in the face of speculative catastrophes is a recipe for repeated waste of resources and health scares, induced by influenza experts with vested interests in exaggeration. There is no reason for expecting any upcoming pandemic to be worse than the mild ones of 1957 or 1968,⁷ no reason for striking pre-emptively, no reason for believing that a proportional and balanced response would risk lives...

The key to responsible policy-making is not bureaucracy but accountability and independence from interest groups. Decisions must be based on adaptive responses to emerging problems, not on definitions...

Rewriting the history of pandemic swine flu (to justify vaccine policies?)

Remember the 2009 Swine Flu Pandemic?  There were going to be a huge number of illnesses and deaths, but then it turned out the flu virus caused less severe disease than usual.  

• Since then, the H1N1 swine flu virus has remained in circulation, and we have continued to have fewer reported flu deaths in the US and abroad than in prior, recent years.

• Children, lacking prior immunity, were said to be at terrible risk--but then it turned out  that although there were 2-3 times as many pediatric flu deaths in 2009-10 as during an average season, the flu season lasted much longer than usual.  CDC reported 133 child flu deaths in 2008-9, 282 in 2009-10, 122 in 2010-11 and 33 in 2011-12.

• We were in dire need of vaccines, so it was said.  Therefore a bizarre vaccine approval process was instituted.  

This process was crafted to mislead the public.  Vaccines were approved on the basis of prior testing of so-called "mock-up vaccines".  The mock up vaccines were actually old bird flu vaccines tested years earlier for a potential bird flu epidemic.  They contained the same adjuvants as swine flu vaccines, but the antigens were completely different.  According to WHO:

... some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.

Approval of the new vaccines rested on sleight of hand:  regulatory agencies made the claim that the two vaccines were substantially identical.  Therefore, data from tests of old bird flu vaccines provided the proof needed to demonstrate safety and effectiveness of new swine flu vaccines.  According to the Guardian:

The clinical trials on which approval was based involved more than 6,000 people for each vaccine, each of whom received a version which was basically the same as the one to be rolled out, but originally contained an avian flu (H5N1) strain – which had been expected to cause a pandemic – instead of H1N1.

And POOF! -- hundreds of millions of people received the new, untested vaccines.

Later came the bad news.  

The epidemic was actually mild, and most of those affected had few if any symptoms.

The vaccines had been given late, when most of the epidemic had passed, and many vaccinated people were already immune.  The vaccine probably had little impact on the pandemic.

The shot itself was dangerous.  Glaxo's version caused 13 times the expected number of cases of narcolepsy in children, and different versions increased the risk of Guillain-Barre syndrome.

WHO was awash with conflicts of interests:  the names of its advisory groupmembers were kept secret; many, it turned out, had ties to vaccine manufacturers.  A watering down of the way a pandemic was defined by WHO led to calling swine flu a pandemic early on.  This activated preexisting contracts between nations and pharmaceutical manufacturers, requiring vaccines to be made and countries to purchase them: creating a captive vaccine market.

The Council of Europe got into the act, investigating WHO and the provenance of the contracts to understand how billions of healthcare dollars were spent to buy and administer unnecessary vaccines.

WHO (the World Health Organization) didn't take the assault lying down.  It arranged for its own investigation, which unsurprisingly found no big mistakes.

In 2010, CDC thought the US vaccine caused nearly a doubling of GBS cases.  In July, new Canadian evidence revealed a doubling or tripling of the Guillain Barre rate after swine flu vaccination to 2 cases per million doses.  An even greater increase to 5 cases of GBS per million swine flu vaccine doses was identified in a Harvard Med School study in June.  

Instead of acknowledging these findings and planning for better vaccine testing, the swine flu pandemic's history was rewritten. 

Although Bloomberg/Businessweek mentioned the study showing a doubling of the GBS rate, it concluded flu vaccine was safe in pregnancy:

Today’s research and a Canadian study looking at the vaccine’s effect on Guillain-Barre syndrome, a disorder in which the body attacks its nervous system, shows the shot is safe and should be used as a precaution to prevent infection, he said. 

More whitewashing of the data followed:  there were no problems with fertility in women vaccinated during any trimester of their pregnancy.  Here's a link to the Danish study published in JAMA.

Then came more bluster:  actually, it was a really, really bad flu with huge numbers of deaths.  We missed them because we didn't look carefully enough:  they tended to occur in the underdeveloped countries, which is why it took 3 years for CDC to find them.  

Except CDC didn't find them; instead, it estimated them.  What was the authors' conclusion?  

Although no estimates of symptomatic case fatality ratios were available from Africa and southeast Asia, a disproportionate number of estimated pandemic deaths might have occurred in these regions. 

A different review published by CDC scientists in May 2012, honestly noted:

Human infection with H1N1 has generally resulted in low mortality, although certain subgroups... have significantly higher risk of severe disease.

Let's examine the claim of vaccine safety during pregnancy.    

In the US, the major birth defect rate is about 3%.  In the Danish study cited, the major birth defect rate in offspring of women vaccinated during their first trimester was 5.45%.  But in the Danish control group, the major birth defect rate was 4.54%.  

The authors were able to dismiss the high birth defect rate by selecting a control group with a higher than expected rate, and by using groups small enough that the 0.91% increased rate in the vaccinated cohort was not statistically significant.  

Anders Hviid, the last author on the study, was involved in an earlier study that was not sufficiently powered to detect a 2.7-fold increase in GBS following swine flu vaccinations.  He was then able to conclude that "The risk of occurrence of Guillain-Barré syndrome is not increased after pandemic influenza vaccine."

I imagine these are only the first volleys in CDC's attempt to rewrite the history of swine flu and its vaccine, and justify its vaccine policies despite evidence to the contrary.  Keep an eye out for what's next.

UK Going to Vaccinate 1 Million Kids a Year for Flu to Save 1 / Medical News Today

From MedicalNewsToday comes the following misleading information on the dramatic benefits of flu vaccine for kids: 

The UK is set to become the first country in the world to provide all children free of charge with a comprehensive flu vaccination program... 

Once the program is up and running, it will cost the government over £100 million annually, and it will provide cover against flu to up to nine million children. Children will be vaccinated during a six to eight week period due to the nature of the flu season.
A moderate uptake in vaccinations would result in a reduction of around 40% in those affected, which would translate to at least 11,000 fewer hospitalizations in addition to saving around 2,000 lives... 

The program will use a nasal spray vaccine with an excellent safety profile that has been available in the U.S. for approximately 10 years. Even though last year flu levels were low and healthy children are least likely to suffer complications if they acquire the flu, the fact that children have close contact with each other means that they represent a high risk in transmitting the virus on to other, more vulnerable people, such as babies and the elderly.

But where is the UK going to find the 2,000 people being saved?  According to the UK National Health Service in 2004, only 22 deaths in UK children per year are due to flu.

If the vaccine saves 40% of them, as claimed, it would save 9 children's lives per year.  

At 9 children saved per year, it would take 200 years of vaccinating every kid to save 2,000.  

But perhaps vaccinating the children is supposed to be saving the elderly, instead.  More child vaccinations may translate to fewer deaths in elders, so it has been postulated.

According to a 2010 NY Times article, only two studies (one from 1968) provide evidence that vaccinating children prevents flu in adults.  I previously blogged about a study that showed no adult protection from vaccinating children.  

The question of whether and how much child vaccinations help adults remains unanswered.  The question of whether it is ethical to vaccinate children to protect an entirely different demographic group has not even been discussed.  Have parents been told this is the driver for vaccinations?

SO:

Is the UK going to vaccinate 9 million children per year for over 100 million pounds annually to save 9 children, not 2,000? 

And how many side effects and deaths might result from the flu vaccines, which are not fully tested in advance of use, to balance against the one-in-a-million children saved? 

Or is the UK is going to vaccinate 9 million children per year for flu based on two small studies performed 40 years apart, claiming an adult benefit?

Or is the UK going to vaccinate 9 million children for 100 million pounds per year in order to transfer money from the public coffers to the pharmaceutical friends of politicians?

You make the call.