MISUNDERESTIMATED: Anthrax Vaccine's New Label Misses Most Adverse Events

The May 2012 updated anthrax vaccine package insert (a.k.a. label) provides cause for concern.  Would you give this vaccine to your dog, let alone your child?  Next week the Presidential Commission for the Study of Bioethical Issues will have their final meeting to discuss giving anthrax vaccine to children.  Whose children would be sacrificed?

1.  An arithmetic error reduced the rate of serious adverse events (SAEs) by a factor of ten.  

"The percent of serious adverse events was similar between the BioThrax combined groups (193/1303 or 1.5%) and the placebo group (38/260 or 1.5%)."  page 6

These fractions correspond to 14.8% in the study group and 14.6% in the placebo group, not 1.5%.  However, these numbers may not be correct.  The 2008 JAMA paper on the same trial indicated that about 40 subjects had multiple SAEs.  Whether the numerators correspond to the total number of SAEs or the number of people with SAEs is uncertain.  Of more importance is a breakdown of what symptom(s) each SAE represented clinically, its duration and whether it resolved.  This is missing from both the text and tables.  

According to CDC's P.I. for this trial, Jennifer Wright (slides 26-27) and FDA, a Serious Adverse Event is defined as "one that results in death, is life-threatening, leads to or prolongs hospitalization, results in persistent/ significant disability or congenital abnormality."  229 events fell into this category during the trial.  What were they?

Dr. Wright also notes that the trial analyses were completed in mid 2009 and a final report sent to FDA then.  The trial results have not been made public.

2.  Table 2 (pages 7 and 8 of the label) is a breakdown of local and systemic adverse events in trial participants.  However, half the subjects in the CDC trial are not included.  The number of subjects in Table 2 totals only 775, while there were 1563 trial subjects.  The adverse events for 788 anthrax-vaccinated subjects are missing.  The number of "moderate/severe systemic adverse reactions" in Table 2 totals 65. There were 127 "moderate/severe local adverse reactions".  Yet the 2008 JAMA paper reported 229 serious adverse events for which VAERS were filed.

3.  The vaccine is dangerous in pregnancy.  (Pregnancy Category D*)

"BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus."  page 3 of the package insert

Yet during the CDC clinical trial, 

"Of women who received vaccine within 90 days of the estimated date of conception (n = 14), 2 spontaneous abortions and a first trimester intra-utero fetal death were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality. "  page 6

Fifty-one pregnancies occurred during the trial (or 48 according to CDC's PI powerpoint presentation).  Why weren't women evaluated for pregnancy before receiving each vaccine dose, given the vaccine's known teratogenicity, and the trial protocol, which required subjects to use a birth control method and be non-pregnant?  Exclusion criteria for the trial included: 

"Pregnancy or plans to become pregnant for the duration of the study and/or not agreeing to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination."  

The package insert tells practitioners, "Advise women of the potential risk to the fetus."  page 15                       

4.  The abbreviated CDC Gulf War Syndrome definition remains a reported adverse event in the package insert:

"Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system." page 9

5.  The vaccine hurts more than other vaccines.  

"Up to 11% of subjects rated the brief pain or burning they experienced immediately after vaccine injection as 8 out of 10 or greater." page 5

6.  Women have significantly more local and systemic adverse events than men.  No numbers are given.  page 5

7.  The "Information for Patients" states on page 16:

What are the possible or reasonably likely side effects of BioThrax? 

• Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot   

• Muscle aches  

• Headaches  

• Fatigue  

• Fainting

*  Pregnancy Category D

"There is positive evidence of human fetal risk based on adversereaction data from investigational or marketing experience or studiesin humans, but potential benefits may warrant use of the drug inpregnant women despite potential risks"

In terms of giving this vaccine to children and teens, potential harms that can reasonably be anticipated include syncope and risk to the fetus if a young recipient becomes pregnant.  Fifteen percent of subjects might experience a severe adverse event "that results in death, is life-threatening, leads to or prolongs hospitalization, results in persistent/significant disability or congenital abnormality."

Can such anticipated adverse events be justified in a pediatric trial for a condition that does not exist in children at this time, and probably never will?

Web of Anthrax Vaccine Conflicts at the Presidential Commission for the Study of Bioethical Issues

You can't make this stuff up.  Conflicts of interest abound at the Presidential Commission for the Study of Bioethical Issues with respect to anthrax vaccine.  Coincidence or forethought?

Before Emergent Biosolutions made anthrax vaccine, the vaccine was made by the Michigan Department of Public Health.  Before Michigan, it was made by Merck.

Might Merck Vaccine's President Julie Gerberding and former Merck Vaccine President Adel Mahmoud have an interest in demonstrating anthrax vaccine's safety and efficacy... and wouldn't giving it to children help demonstrate how excellent it is?  Maybe Dr. Mahmoud, a member of the Presidential Commission's International Research Panel and current Princeton professor, is not providing the Commission with any information or opinions on anthrax vaccine, but then again, maybe he is.

Julie Gerberding led the CDC until 2009; CDC is responsible for procuring anthrax vaccine for the civilian stockpile, making recommendations for its use, running anthrax vaccine clinical trials, etc.


Dr. Amy Gutmann, Commission Chairperson, has one child. Her accomplished daughter is a Princeton professor and consults for Merck.

Lisa Lee, Executive Director of the Commission, worked at CDC from 1998 until joining the Commission.

James W. Wagner, the Presidential Commission's Vice Chair, is president of Emory University, which is CDC's academic partner.

The mysterious (unpublished) clinical trial of anthrax vaccine sponsored by CDC from 2002 to 2007 according to CDC (or through 2010 according to ClinicalTrials.gov) was conducted at five sites, which included Commission members Dr. Wagner's Emory University and Dr. Nelson Michael's Walter Reed Army Institute of Research.  Dr. Greg Poland ran the trial at Mayo, btw.  (See below for info on Dr. Poland.)

According to CDC's anthrax vaccine clinical trial principal investigator, the trial's final analyses were conducted in 2009, and a final report was sent to FDA at that time.  Three and a half years later it remains unpublished.

Dr. Alexander Garza, another Commission member, is the Assistant Secretary for Homeland Security responsible for a new program to get anthrax vaccinations into non-military personnel.

Next week, the Commission will meet again to decide whether to give little children a vaccine that causes birth defects, Gulf War Syndrome and a host of other problems;  according to GAO,

"Officials from the VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death."

Will Bioethics or Vested Interests rule?  Tune in Jan 14-15, for the Commission's next meeting. 

Dr. Julie Gerberding doesn't want you to miss a dose: she ran CDC, now she is president of Merck Vaccines

Expanding the Influenza Vaccination Season: A New Paradigm for Increasing Immunization Rates / Am J Medicine

Poland served as "faculty" for this little paper, whose goal was to push flu vaccinations beyond the end of flu season, helping to use up the oversupply:

Access to influenza vaccination is no longer constrained by problems in supply and distribution, as more manufacturers are providing more influenza vaccine to the US market than ever before. Vaccination throughout the entire influenza season, not just in the early months, is the only way to fully utilize the available vaccine and to meet the target vaccination levels established by the USPHS. High-risk patients make office visits on a regular basis throughout the influenza season but fail to receive the vaccine. Thus, healthcare providers are missing important opportunities to vaccinate millions of people, from October to May every year. To increase vaccination rates in at-risk patients, healthcare professionals should emphasize the need for vaccination throughout the influenza season.

Gregory A. Poland, MD, provided consulting advice and/or performed clinical research trials for Avianax, CSL Limited, GlaxoSmithKline, Merck & Co., Novavax, PowderMed, Protein Science, and Novartis Vaccines.

Poland's 2011 NEJM disclosure form indicated relationships with the following 24 companies:

Merck (chair of at least two Merck committees), Novavax, Protein Sciences, Wyeth, Novartis, GlxoSmithKline, CSL Biotherapies, CSL Limited, Dynavax, Powdermed, Emergent BioSolutions (anthrax vaccine), Theraclone Sciences, MedImmune LLC, Liquidia Technologies, Inc., PaxVax, Inc., EMD Serono, Inc., Haymarket Medical, Audio Digest Foundation, SciMed LLC, Pri-Med Institute, Discovery Institute of Medicine, American Medical Directors Association, Medscape CME and Pacific EMPRINTS.

SpinDoc Greg Poland's "Requiring influenza vaccination for health care workers: seven truths we must accept" / Vaccine

Poland's 2005 paper is one of those designed to pay the way to mandatory influenza vaccinations.  Back in 2005 Poland did not dare to ask for healthcare worker (HCW) firings, nor to junk philosophical exemptions, as he does now.  The paper uses Polandese to make the benefits of vaccination appear much greater than they are.  I provide some facts after each of Poland's assertions.

Abstract
In this paper we outline the seven primary truths supporting the call for requiring influenza immunization of all health care workers. We view this as a serious patient safety issue, given the clear and compelling data regarding the frequency and severity of influenza infection.  In addition, clear-cut safety, efficacy, economic, legal, and ethical platforms support the use of influenza vaccine.   Unfortunately health care workers have demonstrated, over almost 25 years that they are unwilling to comply with voluntary influenza immunization programs utilizing a variety of education and incentive programs, at rates sufficient to protect the patients in their care. We suggest that an annual influenza immunization should be required for every health care worker with direct patient contact, unless a medical contraindication or religious objection exists, or an informed declination is signed by the health care worker. High rates of health care worker immunization will benefit patients, health care workers, their families and employers, and the communities within which they work and live.

The first truth: influenza infection is a serious
illness causing significant morbidity and mortality
adversely affecting the public health on an annual
basis

Fact:  Most cases are subclinical (no symptoms) and the vast majority of deaths that do occur, occur occur in people who are extremely frail and would not live much longer even if they did not develop the flu.

The second truth: influenza-infected health care
workers can transmit this deadly virus to their
vulnerable patients

Fact:  There is no reliable evidence that they do so, particularly if they do not come to work coughing or sneezing, which is how the disease is transmitted

The third truth: influenza vaccination of health
care workers saves money for employees and
employers and prevents workplace disruption

Fact:  It may help employers

The fourth truth: influenza vaccination of health
care workers is already recommended by the CDC
and is the standard of care

Fact:  CDC's flu vaccine recommendations are not science-based, as shown earlier in this blog. "Standard of care" is a medico-legal term that suggests a particular practice is "standard."  Since less than 50% of HCWs got yearly flu vaccines, it could not be considered a standard.

The fifth truth: immunization requirements are
effective and work in increasing vaccination rates

Fact:  Requirements are effective at increasing vaccination rates, but there is no evidence they are effective at reducing mortality or morbidity in patients, which is the supposed reason they are being mandated.

The sixth truth: health care workers and health
care systems have an ethical and moral duty to
protect vulnerable patients from transmissible
diseases

Fact:  HCWs have an obligation to protect patients, which is why frequent handwashing, and staying home from work when contagious, are important and proven measures to protect patients.  If/when a truly safe and highly effective flu vaccine is developed, it might be reasonable to require HCW vaccinations.  But for now, in the absence of an excellent and fully-tested flu vaccine, that is not the case.

The seventh truth: the health care system will
either lead or be lambasted

As I noted in a previous post, this "truth" is spin.  Are HCWs to be blamed for the many failings of the healthcare system?  Why not focus instead on the 44,000-98,000 Americans who die in hospitals each year from adverse drug reactions?  A well-read 1999 report by the Institute of Medicine (TO ERR IS HUMAN:  BUILDING A SAFER HEALTH SYSTEM) said:

Among the problems that commonly occur during the course of providing health care
are adverse drug events and improper transfusions, surgical injuries and
wrong-site surgery, suicides, restraint-related injuries or death, falls, burns,
pressure ulcers, and mistaken patient identities.  High error rates with serious
consequences are most likely to occur in intensive care units, operating rooms,
and emergency departments.  

Beyond their cost in human lives, preventable medical errors exact
other significant tolls.  They have been estimated to result in total costs (in­
cluding the expense of additional care necessitated by the errors, lost income
and household productivity, and disability) of between $17 billion and $29
billion per year in hospitals nationwide.

Tellingly, influenza deaths are not even mentioned.  IOM pointed out the areas where the healthcare system has to lead.  Remember:  flu deaths in the elderly have not fallen since 1980, when only 15% of seniors were vaccinated, till today, when 65% get yearly flu vaccines.

Flu Vaccine Pusher Greg Poland says "Anything Goes"

One person has been instrumental in creating flu vaccine mandates in the US, and he continues to push them overseas as well:  Mayo's Greg Poland, MD.

Poland is a scoundrel.  He enjoys throwing punches below the belt, and brags about it.  He placed on his Mayo website:  "In Dr. Poland's war, there are no rules of engagement; anything goes." (Actually, he scrubbed it from the original page, which I previously cited, but you can still find the quote here.)

He helps write position papers and then cites them, without mentioning his role in creating them.  Here is one from the Society for Healthcare Epidemiology of America which he coauthored and then cited to support mandatory vaccinations.  He was key in writing the Infectious Diseases Society of America guidelines here.  [These guidelines are brazen in demanding money ("Significant and sustainable funding for long-term planning and action") from Congress, state and local governments for a variety of flu-related activities and procurements.  See page 19.]  Follow the money and understand how Poland benefits personally from the policies he pushes.

From the Mayo Clinic website comes this 2010 accolade to Poland:

Dr. Poland is a special government employee with appointments with the U.S. Department of Defense and the CDC. He has sat on every federal committee that deals with vaccines. Representing the American College of Physicians, he and fellow committee members advise the Department of Health and Human Services on vaccines and who should receive them. In his government work, he is particularly proud of one accomplishment.
“I had introduced a resolution to this committee three times to recommend universal influenza immunization, and this past meeting in February they finally approved it,” he says proudly. “Now every American will be recommended to receive the influenza vaccine this year.”

Poland claims to be an expert in medical ethics and law, as well as public policy, all to aid the forced administration of more and more vaccine.  Here is a recent abstract; the link above will give you the full text:

Am J Public Health. 2011 Feb;101(2):212-6. doi: 10.2105/AJPH.2009.190751.
Vaccinating health care workers against influenza: the ethical and legal rationale for a mandate.
Ottenberg AL, Wu JT, Poland GA, Jacobson RM, Koenig BA, Tilburt JC.

Bioethics Research Program, Mayo Clinic, Rochester, MN 55905, USA. ottenberg.abigale@mayo.edu 

Abstract
Despite improvements in clinician education, symptom awareness, and respiratory precautions, influenza vaccination rates for health care workers have remained unacceptably low for more than three decades, adversely affecting patient safety. When public health is jeopardized, and a safe, low-cost, and effective method to achieve patient safety exists, health care organizations and public health authorities have a responsibility to take action and change the status quo. Mandatory influenza vaccination for health care workers is supported not only by scientific data but also by ethical principles and legal precedent. The recent influenza pandemic provides an opportunity for policymakers to reconsider the benefits of mandating influenza vaccination for health care workers, including building public trust, enhancing patient safety, and strengthening the health care workforce. 

Acknowledgments
Abigale L. Ottenberg, Joel T. Wu, Barbara A. Koenig, and Jon C. Tilburt have no disclosures. Gregory A. Poland has offered consultative advice on novel influenza vaccine development to Merck & Co., Inc., Avianax, Theraclone Sciences (formally Spaltudaq Corporation), MedImmune LLC, Liquidia Technologies, Inc., Novavax, Sanofi Pasteur, and PAXVAX, Inc. Robert M. Jacobson serves as the Principal Investigator on a Pfizer-funded study ex- amining PCV 13 in adults, which involves, in part, adult receipt of the influenza vaccine.

In 2007 he disclosed serving as a consultant to these vaccine companies:  

Dynavax, 

Novavax, 

Merck, 

Protein Sciences, 

GlaxoSmithKline, 

Novartis Vaccines, 

CSL Biotherapies, and 

Avianax. 

Call to Action to vaccinate HCWs (via National Foundation for Infectious Diseases)paid for by Sanofi-Pasteur

National Foundation for Infectious Diseases. Call to action: Influenza immunization among
health care personnel. Bethesda, MD, 2008.  Sponsored by Sanofi.

*  In the context of this document, the term “health care personnel” extends to all persons
working in health care settings, including home health care, who have contact with
patients. This includes not only traditionally identified medical staff (e.g., physicians, nurses, physician assistants, etc.), but also therapists, technicians, laboratory personnel, pharmacists, students and trainees, volunteers and non-medical personnel who may come into contact with vulnerable patients (e.g., housekeeping, plant operations, dietary, secretarial, administrative, etc.)

Do you think this suggestion has more to do with protecting patients from secretaries or selling more vaccine vials?

And APIC (Association of Professionals in Infection Control and Epidemiology--mostly RNs), which I discussed last year, also sells itself to Pharma.  It has a similar over-the-top list of people who should receive forced vaccinations:

“[T]he term HCP includes:  all paid and unpaid persons working in health-care settings who have the potential for exposure to patients with influenza, infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces or contaminated air. HCP might include (but are not limited to) physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff not employed by the health-care facility, and persons (e.g., clerical, dietary, housekeeping, maintenance, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from HCP. The recommendations in this report apply to HCP in acute care hospitals, nursing homes, skilled nursing facilities, physician's offices, urgent care centers, and outpatient clinics, and to persons who provide home health care and emergency medical services."

What, in Fact, Is the Evidence That Vaccinating Healthcare Workers against Seasonal Influenza Protects Their Patients? A Critical Review/ Int J Family Medicine

Yet another just-published literature review, this time from Israel, finds mandatory healthcare worker flu vaccinations unsupported by the literature.

Int J Family Med. 2012;2012:205464. doi: 10.1155/2012/205464. Epub 2012 Nov 11. 

What, in Fact, Is the Evidence That Vaccinating Healthcare Workers against Seasonal Influenza Protects Their Patients? A Critical Review.
Abramson ZH. 

Source
Department of Family Medicine, Hebrew University-Hadassah School of Public Health, Ein Kerem, Jerusalem 91120, Israel ; Beit Hakerem Community Health Center, Clalit Health Services, Haarazim 2, Jerusalem 96182, Israel. 

Abstract
Background and Methods. Vaccination of all healthcare workers is widely recommended by health authorities and medical institutions and support formandatory vaccination is increasing. This paper presents the relevant literature and examines the evidence for patient benefit from healthcare workervaccination. Articles identified by Medline searches and citation lists were inspected for internal and external validity. Emphasis was put on RCTs. The literature on self-protection from vaccination is also presented. Results. Published research shows that personal benefit from vaccinating healthy nonelderly adults is small and there is no evidence that it is any different for HCWs. The studies aiming to prove the widespread belief that healthcare worker vaccination decreases patient morbidity and mortality are heavily flawed and the recommendations for vaccination biased. No reliable published evidence shows that healthcare workers' vaccination has substantial benefit for their patients-not in reducing patient morbidity or mortality and not even in increasing patient vaccination rates. Conclusion. The arguments for uniform healthcare worker influenza vaccination are not supported by existing literature. The decision whether to get vaccinated should, except possibly in extreme situations, be that of the individual healthcare worker, without legal, institutional, or peer coercion.
Free full text PMC Article

Flu Vaccine Mandates and Talking Points funded by Pharma, naturally

I did not have to look far to find the source of that meaningless little factoid used by the Goshen hospital spokesperson and the British Columbia chief medical officer: 

"Influenza is the most frequent cause of death from a vaccine-preventable disease in the United States."  

It was the very first sentence in a flu vaccine "resource" for health professionals on the Immunization Action Coalition website.  Guess all you need is to read a sentence or two and then you have enough ammunition to fire your employees.

Who funds the Immunization Action Coalition (IAC)?  An unholy alliance of CDC, Big Pharma, Pharmacists, Health Plans and others.  

The IAC has created an "Honor Roll" of institutions that force flu vaccine on their employees and make their lives miserable if they don't comply:

Honor Roll for Patient Safety Mandatory Influenza Vaccination for Healthcare Workers IAC is recognizing the stellar examples of influenza vaccination mandates in healthcare settings. The best way to prevent transmission of influenza to our patients is to mandate vaccination of healthcare workers. The Honor Roll represents the champions who have taken the lead in mandating influenza vaccination within their organization or institution. To be included in the honor roll, your organization's mandate must require influenza vaccination for employees and must include serious measures to prevent transmission of influenza from unvaccinated workers to patients. Such measures might include a mask requirement, reassignment to non-patient-care duties, or dismissal of the employee.

The list of who pays for this includes:

National Center for Immunization and Respiratory Diseases, CDC

Foundations

Mark and Muriel Wexler Foundation Anonymous

Pharmaceutical Companies

Baxter Healthcare Corp. CSL Biotherapies GlaxoSmithKline MedImmune, Inc. Merck Sharp & Dohme Corp. Novartis Vaccines Ortho Clinical Diagnostics, Inc. Pfizer Inc. sanofi pasteur

Professional Societies

American Pharmacists Association

Individuals and Others

Combined Federal Campaign donors Health plans Hospitals

No they don't write it themselves: No-Nothing Vaccinator #3

No, the vaccinators don't write their talking points themselves.  They get them from the same playbook.

The spokeswoman for Goshen Hospital, which just fired 8 employees, justified forced vaccinations with the identical (meaningless) argument as British Columbia's Chief Medical Officer:

... hospital spokeswoman Melanie McDonald told the Elkhart Truth: “The flu has the highest death rate of any vaccine preventable disease, and it would be irresponsible from our perspective for health care providers to ignore that.”

However, there is no evidence that giving either the elderly or healthcare workers flu vaccines would save any lives.  And we don't actually know how many people die from flu.  We just make mathematical models of flu deaths, because flu is so rarely written on death certificates as a cause of death, since doctors rarely judge a death to be due to flu... rather, we blame the underlying illness.  The vast majority of flu-associated deaths occur in people who were close to death already. So what does this statement mean, if anything?

Goshen Hospital spokeswoman McDonald is quoted by the Associated Press as saying, 

"the new requirements came as a recommendation from the U.S. Centers for Disease Control and Prevention, the American Medical Association and other major health agencies." 

Yet neither organization made a recommendation to fire employees.  Here is the AMA position.  Here is the CDC recommendation.  So where is the vehemence to fire coming from?   Why are the facts about the poor efficacy of the vaccine being hidden?

Know-Nothing Flu Vaccinators: #2

Professor Ken Flegel, an editor of the Canadian Medical Association Journal, wrote an editorial last fall supporting mandatory flu shots for healthcare workers.  I blogged about his standard for vaccination last November, but did not critique many other problems with the article.  Somehow, like Perry Kendall, Dr. Flegel got his citations (and his ideas) all wrong.

Makes you wonder if they really write this stuff themselves... how can they be so vehement when they apparently don't know the subject or the relevant literature?

Flegel got his comeuppance from many expert authors.  I encourage you to read their comments here, as they are both edifying and amusing.

Flu Shots: Clearing the Air, Correcting the citations/ Vancouver Sun

British Columbia 's chief medical officer pushed mandatory flu shots for healthcare workers, then backed up the policy with specious claims, showing he had not a clue what the science really said.  The Cochrane Collaboration's Tom Jefferson, MD, a flu vaccine expert who had reviewed the world literature and coauthored several Cochrane meta-analyses on the usefulness of the vaccine, brought him to task.  Too good to excerpt, here it is in full:

Dr. Perry Kendall’s responses to my comments (in Monday’s Vancouver Sun) are as disturbing as his original misreporting of my research. He states that the influenza vaccine is “60 per cent effective” and concludes that it reduces the chances somebody will pick up the virus and pass it on to patients. The figure of 60 per cent is a relative estimate which gives an inflated impression of performance. The best evidence of the performance of the influenza vaccine comes from trials in healthy adults. The relevant Cochrane review was first published in 1999 and has been updated several times since. The review shows that you need to vaccinate between 33 and 99 adults to avoid the onset of symptoms in one person. On average the vaccines prevent the loss of half a working day. There is no evidence in any literature that the vaccine avoids person-to-person spread as (chief health officer for B.C.) Kendall seems to imply. Another of his statements shows just how ideologically-driven his policies are. “When asked how many patients die each year because they pick up viruses like the flu, Kendall said he didn’t know because the information is not routinely collected.” If he does not know how many people die because of influenza, how does he know it’s a problem of such proportion to justify coercive policies? Also, how will he evaluate his policy which has caused so much resistance? If he does not know what the “before” looks like, how is he going to compare it with any “after” to assess whether Canadian taxpayers’ cash is well spent?

Perhaps the most bizarre of the statements made is that The Lancet, the British Medical Journal, the Canadian Medical Association Journal, the Society for Healthcare Epidemiology in the United States, they’ve all called for mandatory immunization of health care workers. Could Kendall please give us references to the BMJ and Lancet endorsement of mandatory immunization with influenza vaccines? The Canadian Medical Association Journal recently published an editorial with a misquote of our Cochrane review which was as distorted as Kendall’s.

The points made by Dr. Paul van Buynder and colleagues are equally vague. Van Buynder and colleagues state that the Cochrane Collaboration has a “narrow evidentiary standard.” Had they bothered to read our reviews they would have discovered that all relevant studies comparing vaccination of children, adults, elderly and health care workers with no vaccination have been included.

The problem is not inclusion, it’s the quality of what is included, as I have already explained. The are many studies in literature that conclude that vaccination of health care workers and healthy adults works well, but bias in these studies is so great that the vaccines appear to work against death for all causes, but not against death from respiratory infections.

Following this perverted logic would have inactivated vaccines save lives from accidents, strokes, accidental poisoning, hypothermia and falls, but not from influenza and pneumonia? Either the inactivated vaccines are miracle workers or there is something very wrong with the evidence. Cochrane reviews weigh the evidence by its quality, not by their conclusions, to allow interpretation of the study results with some confidence — this has nothing to do with “good” or “perfect.”

The statement that “the logic is indisputable” reveals a high degree of dogmatism. The inactivated vaccines should work in theory, just like many things work in theory, but real evidence suggests they are not having the desired effect. So far we have distortion of research findings, evidence-free statements and evidence-free policies supporting coercion of human beings. What next?

Dr. Tom Jefferson is with the Cochrane Respiratory Infections Group in Rome, Italy. 

British Columbia, Canada reversed itself on mandatory flu shots this season/ Globe and Mail

Canada's first mandatory flu shot policy, announced in August 2012 for all healthcare workers, was reversed in early December, following an uproar by nurses and other health workers.

The nurses’ union, the HSA and the Hospital Employees’ Union, together representing more than 100,000 health-care workers, objected to their members being forced to have a flu shot, or wear a mask, while at work. “Nurses felt it was a real violation of their right to direct their own health care, that it was questioning their own critical judgment.”

BC Provincial Health Officer Perry Kendall created the policy, yet admitted he did not know how many people died from flu.  According to the Vancouver Sun,

When asked how many patients die each year because they pick up viruses like the flu, Kendall said he didn't know because the information is not routinely collected.

Yet Kendall had earlier claimed, "Influenza causes more deaths annually than all other vaccine-preventable diseases combined..."   Duh...

It is unfortunate that he and so many other policymakers seem to get their information from power points, likely authored by industry, which provide them pithy statements for the media.  But when challenged, they lack basic information on the subject in question.

Finally, Kendall was overruled by his bosses:

The decision to hold off disciplining health-care workers who refuse to get a flu shot or wear a mask was made without consulting the province’s chief public health officer, who announced the landmark policy in the first place.

Provincial Health Officer Perry Kendall said he learned of the softened approach only after it was approved late last week by a group consisting of deputy health minister Graham Whitmarsh and CEOs of the province’s regional health authorities...

But the new policy produced an uproar among unionized health-care workers. Their unions filed grievances against the mandatory nature of the decree, arguing that immunization was an individual decision and evidence on the benefits of flu shots was weak... 

Already, likely because of the earlier threat of discipline, flu shot rates among health-care workers are at record levels this year. At Fraser Health, more than 70 per cent of staff have now been immunized, nearly twice the level of previous years.

Threaten someone with the loss of their job, and they may get the shot.  However, the fact that only 35% of healthcare workers have been vaccinated, when they have a bird's eye view of the effects of the vaccine and the impact of flu on patients, suggests the vaccine benefit does not impress those with the greatest personal experience.  (Per CDC, 37% overall get vaccinated in the US.)

Why force flu vaccinations if the evidence is so poor?

The Lancet investigated flu vaccine effects with the following two interesting studies:

1.  Simonsen et al. showed that as rates of flu vaccination in the elderly rose in the US from 15% to 65%, there was no corresponding decrease in elder deaths from flu!

2.  Carman et al. found that: 

Vaccination of health-care workers was associated with a substantial decrease in mortality among patients. However, virological surveillance showed no associated decrease in non-fatal influenza infection in patients.

In facilities where more healthcare workers got vaccinated (voluntarily), Carman found the overall death rate in patients was lower. However, the patients in those facilities did not have less flu!  So the difference in death rates can't be blamed on flu, and the only explanation is confounding.

Although there are many published papers about the attitudes and beliefs of healthcare workers with respect to flu shots, no reliable data exist to support the usefulness of healthcare worker shots on patient outcomes.  So what is really going on here?

Without being a fly on the wall in the halls of federal medicine, I can only speculate.  Here are some ideas about what might be driving the vehemence of flu vaccine mandates.  Do you have any other ideas?

1.  Deliberately shifting the culture of medical professionalism to a culture of obedience:  get the shot or else wear a mask (even though the data show that it does no good unless you are coughing or sneezing) or be fired.

2.  Mission Creep.  You begin by mandating shots for healthcare workers and then expand the mandate to the entire population.  Fifteen years ago flu shots were only for those over 65, but CDC slowly expanded the recommendations to now include the entire US population over 6 months of age.  The NY Times says CDC wants 80% of Americans vaccinated yearly by 2020.  (Less than 50% are now.)

3.  Creating scapegoats (unvaccinated health workers) for the sorry state of US healthcare and US life expectancy -- we are #38.

4.  Forcibly expanding pharma's flu vaccine market.

5.  Creating a market for specific, well-connected companies just entering the flu vaccine field, such as Emergent Biosolutions, the anthrax manufacturer, which will now be making pandemic flu vaccines.  This is the result of a recent $220 million contract with DHHS’ Biomedical Advanced Research and Development Authority, and is in addition to its anthrax vaccine contracts. 

Flu shots (and especially pandemic flu shots) are tested less than all other vaccines before use, due to the brief interval between deciding on their composition and administering them.  One must therefore rely on the reputation of the manufacturer  to gauge product quality.  Emergent Biosolutions has a track record of shoddy manufacture.  This is another reason to avoid future flu shots.

6.  Paving the way for more vaccine mandates as the hundreds of vaccines in development enter the market.  Mandatory flu vaccines may serve as a trial balloon to see how the US public responds to vaccine mandates for grownups.

7.  Completing the replacement of medical science by medical marketing.

Meta-analyses of flu vaccine effectiveness/ Cochrane Collaboration

The Cochrane Collaboration, the most respected organization of health professionals to evaluate the evidence behind medical therapies, studied flu vaccine of healthcare workers in 2006 and again in 2010.

In 2006 they concluded:

There is evidence that vaccinating the elderly has a modest impact on the complications from influenza. There is also high quality evidence that vaccinating healthy adults under 60 (which includes healthcare workers) reduces cases of influenza. Both the elderly in institutions and the healthcare workers who care for them could be vaccinated for their own protection, but an incremental benefit of vaccinating healthcare workers for the benefit of the elderly cannot be proven without better studies.

NO evidence supports the wholesale vaccination of healthcare workers to protect patients. 

In 2010 Cochrane concluded:

Influenza vaccination for healthcare workers who work with the elderly 

Authors' conclusions

No effect was shown for specific outcomes: laboratory-proven influenza, pneumonia and death from pneumonia. An effect was shown for the non-specific outcomes of ILI, GP consultations for ILI and all-cause mortality in individuals ≥ 60. These non-specific outcomes are difficult to interpret because ILI includes many pathogens, and winter influenza contributes < 10% to all-cause mortality in individuals ≥ 60. The key interest is preventing laboratory-proven influenza in individuals ≥ 60, pneumonia and deaths from pneumonia, and we cannot draw such conclusions. 

There are no accurate data on rates of laboratory-proven influenza in healthcare workers. 

The three studies in the first publication of this review and the two new studies we identified in this update are all at high risk of bias. 

The studies found that vaccinating healthcare workers who look after the elderly in long-term care facilities did not show any effect on the specific outcomes of interest, namely laboratory-proven influenza, pneumonia or deaths from pneumonia. An effect was shown for outcomes with a non-specific relationship to influenza, namely influenza-like illness (which includes many other viruses and bacteria than influenza), GP consultations for influenza-like illness, hospital admissions and the overall mortality of the elderly (winter influenza is responsible for less than 10% of the deaths of individuals over 60 and overall mortality thus reflects many other causes). 

Healthcare workers have lower rates of influenza vaccination than the elderly and surveys show that healthcare workers who do not get vaccinated do not perceive themselves at risk, doubt the efficacy of influenza vaccine, have concerns about side effects, and some do not perceive their patients to be at risk. This review did not find information on other interventions that can be used in conjunction with vaccinating healthcare workers, for example hand washing, face masks, early detection of laboratory-proven influenza in individuals with influenza-like illness by using nasal swabs, quarantine of floors and entire long-term care facilities during outbreaks, avoiding new admissions, prompt use of anti-virals, and asking healthcare workers with an influenza-like illness not to present for work. 

We conclude that there is no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza, pneumonia, and death from pneumonia in elderly residents in long-term care facilities. Other interventions such as hand washing, masks, early detection of influenza with nasal swabs, anti-virals, quarantine, restricting visitors and asking healthcare workers with an influenza-like illness not to attend work might protect individuals over 60 in long-term care facilities and high quality randomised controlled trials testing combinations of these interventions are needed.

Workers fired, but where did the guidance to fire them come from?

What is up with firing workers who don't get vaccinated for flu?  Indiana's Goshen Hospital just fired 8 workers for refusing the shots.  

Hospital spokeswoman Melanie McDonald told The Elkhart Truth the new requirements came as a recommendation from the U.S. Centers for Disease Control and Prevention, the American Medical Association and other major health agencies.

Did they really recommend firing refusers?  Of course not.  Not officially.  The actual ACIP / CDC recommendation is the following:

The most effective combination of approaches for achieving high influenza vaccination coverage among HCP likely varies by institution. Hospitals and health-care organizations in the United States traditionally have employed an immunization strategy that includes one or more of the following components: education about influenza, easy access to vaccine, incentives to encourage immunization, organized campaigns, institution of declination policies, and legislative and regulatory efforts (e.g., vaccination requirements)

 The latest AMA Code of Ethics (2011) states:

As professionals committed to promoting the welfare of individual patients and the health of the public and to safeguarding their own and their colleagues’ well-being, physicians have an ethical responsibility to take appropriate measures to prevent the spread of infectious disease in health care settings.  Conscientious participation in routine infection control practices, such as hand washing and respiratory precautions is a basic expectation of the profession.  In some situations, however, routine infection control is not sufficient to protect the interests of patients, the public, and fellow health care workers. 

In the context of a highly transmissible disease that poses significant medical risk for vulnerable patients or colleagues, or threatens the availability of the health care workforce, particularly a disease that has potential to become epidemic or pandemic, and for which there is an available, safe, and effective vaccine, physicians have an obligation to: 

(a) Accept immunization absent a recognized medical, religious, or philosophic reason to not be immunized. 

(b) Accept a decision of the medical staff leadership or health care institution, or other appropriate authority to adjust practice activities if not immunized (e.g., wear masks or refrain from direct patient care).  It may be appropriate in some circumstances to inform patients about immunization status. (I, II)

Issued June 2011 based on the report "Routine Universal Immunization of Physicians for Vaccine-Preventable Disease," adopted November 2010.

Michael Osterholm on flu shots: "It's all a sales job; it's all public relations" / NY Times

I missed this November article on flu shots from the NY Times blog.  Yes, it repeats material I have covered before.  But as healthcare workers continue to be fired from their jobs for refusing flu shots, I will continue to post on why their firings make no sense.

Here are excerpts:

It’s flu-shot season, and public health officials are urging everyone over 6 months of age to get one. Many businesses provide on-site flu shots, and some hospitals have told staff members that they have to wear masks if they do not get the vaccine. By 2020, United States health leaders want 80 percent of the population to get yearly shots. 

For vaccine manufacturers, it’s a bonanza: Influenza shots — given every year, unlike many other vaccines — are a multibillion-dollar global business.But how good are they?

Last month,, in a step tantamount to heresy in the public health world, scientists at the Center for Infectious Disease Research and Policy at the University of Minnesota released a report saying that influenza vaccinations provide only modest protection for healthy young and middle-age adults, and little if any protection for those 65 and older, who are most likely to succumb to the illness or its complications. Moreover, the report’s authors concluded, federal vaccination recommendations, which have expanded in recent years, are based on inadequate evidence and poorly executed studies.

“We have overpromoted and overhyped this vaccine,” said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy, as well as its Center of Excellence for Influenza Research and Surveillance. “It does not protect as promoted. It’s all a sales job: it’s all public relations.” Dr. Osterholm, who says he is concerned that confidence in current vaccines deters research into identifying more effective agents, comes from the world of public health and the Centers for Disease Control and Prevention. A bioterrorism and public health preparedness adviser to Tommy Thompson, the former health and human services secretary, he served on the interim management team during a transition period at the C.D.C. in 2002.

“I’m an insider,” Dr. Osterholm said. “Until we started this project, I was one of the people out there heavily promoting influenza vaccine use. It was only with this study that I looked and said, ‘What are we doing?’ ” … While researching the report released last month, Dr. Osterholm said, the authors discovered a recurring error in influenza vaccine studies that led to an exaggeration of the vaccine’s effectiveness. They also discovered 30 inaccuracies in the statement on influenza vaccines put forth by the expert panel that develops vaccine recommendations, all of which favor the vaccine. … (When the vaccine matches the circulating viruses, 33 adults need to be vaccinated to avoid one set of influenza symptoms; when there is only a partial match, 100 people must be vaccinated for the same effect.) It was also concluded that the vaccines appear to have no effect on hospital admissions, transmission or rates of complications. A separate Cochrane review on vaccines for the elderly determined the evidence was so scant and of such poor quality that it could not provide guidance. … Another option for those who want to reduce their risk of influenza and flulike infections may be simply this: Wash your hands more often. There is good evidence this works.