Thursday, May 14, 2015

HR 2322: A One-Size-Fits-All Bill to Vaccinate Every American Child With Every Vaccine CDC/ ACIP Recommend

Wow!  Who saw that coming?  The Constitution did not specify that medical care was a federal responsibility, so for over 200 years it has been left to the states.  Yes, fifty years ago we got Medicare and Medicaid, and now the Affordable (for whom?) Care Act, but the specifics of what drugs and vaccines people receive has been left to the states... and to doctors and patients working collaboratively.

Now we have HR 2232 that says every child, all the time, must receive whatever vaccines a group of industry insiders (CDC's Advisory Committee on Immunization Practices) add to the vaccine schedule.  Is this bill going to be attached as a rider in the dead of night to some other bill and passed before we know it?  The bill is an extraordinary overreach, and it is sad that a black Congresswoman, Frederica Wilson, introduced it.  However, one does not need to look very far to find the long arm of Pharma behind it:  Representative Wilson's senior advisor Kenneth Austin previously worked for Abbott, a pharmaceutical company, and GlaxoSmithKline, a major vaccine manufacturer.


At least the W.H.O. still knows that vaccination decisions should be made through risk-benefit assessment, not one-size-fits-all, shotgun approaches that benefit industry primarily.  We already have the 1995 Vaccines for Children Act that provides vaccines to every child in the country (55%) who might not afford them.  From W.H.O.:

Key point
Risk/benefit assessments should be applied to most situations relating to the efficacy or safety of vaccines to ensure public safety and public health.

Wednesday, May 13, 2015

Immunocompromised children: what are their infectious risks from the unvaccinated?

In the last few days there have been multiple news articles and testimonies in the Maine and Vermont legislatures about the need to impose vaccine mandates to protect immunocompromised children.[1] [2]  I attended the vaccine bills' hearing in Augusta, Maine on May 11, which lasted into the night. I also attended the Vermont Senate hearing 3 weeks earlier.  The Vermont Senate committee said it would only hear testimony from physicians, which is why I was invited. Not very many doctors are familiar with the vaccine literature. Vaccines are, surprisingly, an arcane area of medicine. 

Unfortunately, I heard not a single expert (at either hearing) provide any data about the magnitude of the problem that vaccine mandates are supposed to fix.  In fact, I was quite surprised to learn that helping the immunocompromised seemed to be the major justification to remove vaccine exemptions.

I heard no one mention the fact that vaccine efficacies of 40%, 60%, 80% (approximately correct for influenza, diphtheria, mumps vaccines) might also pose some risk to the immunodeficient.  (These are just examples; most other vaccines have efficacy in the 60-90% range.) Actually, any statistician could tell you that low efficacy poses considerably more risk than exemption rates of 1-5% in Maine (depending on which required vaccine we are discussing). Vaccines with low efficacy make the claim of herd immunity a joke--but did even one "expert" at the hearings know or care?

How much risk is actually posed by “vaccine-preventable” diseases to the immunocompromised? I reviewed the most common infections seen in those at highest risk: stem cell transplant recipients[3] and leukemia patients.[4]

Here is what I found.
"The limited data show that community acquired respiratory viruses (CARVs) and herpesviruses are the most common pathogens. Among the causes of CARV respiratory tract infections, a preponderance of respiratory syncytial virus (RSV) and parainfluenza virus (PIV) are reported, followed by influenza virus and human metapneumovirus (HMPV).  In the herpesvirus family, the incidence of herpes simplex virus (HSV) and varicella zoster virus (VZV) infections as well as cytomegalovirus (CMV) diseases have significantly decreased because of effective prophylaxis. The reports on human herpes virus (HHV)-6 diseases are increasing...
Other viruses, such as herpesviruses and adenovirus, may also result in respiratory infections... Herpesvirus pneumonia is usually caused by reactivation of latent viruses which occurs in severe immunosuppression.
... viral encephalitis was mainly caused by human herpes virus (HHV)-6, followed by EBV, HSV, JC virus, CMV, VZV in the recipients of allo-HSCT. Our data showed that herpesvirus-associated encephalitis was mainly caused by EBV followed by HSV, CMV and VZV...
The most frequent pathogens of viral hepatitis are hepatitis B virus (HBV) and hepatitis C virus (HCV). Besides these, other viruses such as CMV and HSV may also result in hepatitis. Hepatitis B and C can be caused by either virus reactivation or blood transmission..." 
There are also many bacterial and fungal infections they may develop: too many to list.  Of the many infections these patients tend to develop, the only 3 infections commonly seen, for which there exists a vaccine and which spread between children, are chickenpox (varicella zoster virus or VZV), influenza, and rotavirus.

Rotavirus is a relatively mild gastrointestinal virus and mortality, even in those with impaired immunity, is rare.[5] 

Influenza is a real concern, but influenza vaccines are notoriously ineffective.  This year, CDC said the vaccine had 19% efficacy.[6]  (A Canadian study found no efficacy for this year's flu vaccine.) Over the past ten years, CDC’s efficacy estimates for influenza vaccines averaged 40%.[7]  So even if everyone in America was vaccinated, you could not generate herd immunity for influenza.  You could not achieve the desired "cocoon" for those most vulnerable.

Chickenpox is caused by a virus that, once you have been infected, will live forever in your nerve cells. The vaccine virus also does this.  Immunocompromised patients developing chickenpox/VZV infections are usually reactivating latent virus long present in their own bodies.  Only very rarely are they “catching” chickenpox virus from someone else. Fortunately, we have antiviral drugs and immune globulin to prevent and treat these common reactivations.

Let me repeat:  vulnerable, immunodeficient children are susceptible to many viral, bacterial and fungal infections, but these are very rarely caused by child to child spread of microorganisms for which we have vaccines. They are listed in footnotes 3 and 4.  

It is troubling that vulnerable families have been encouraged to fear and stigmatize unvaccinated children, when the rates of primary and secondary vaccine failures (i.e., number of vaccinated kids who lack immunity despite their vaccinations) are far greater than the rates of children lacking vaccinations.  [CDC's 2012-13 kindergarten vaccine exemption rates by state ranged from a low of 0.1% to a high of 6.5%.]  In fact, the vaccine failures pose a much larger risk. But are the immunocompromised suffering and dying due to other childrens' vaccine failures? We are not hearing about it. If the vulnerable are not being harmed by vaccinated children who lack immunity, then it follows they are not suffering from exposure to the unvaccinated, either.

Don’t vulnerable families have enough real problems, without adding unfounded and unjustified fears? Isn't it time to drop this canard?

As I said in an earlier post, the last measles deaths in the United States (there were 2) occurred in 2003.  One was elderly; the other was aged 13 and had had a bone marrow transplant. I was unable to learn if his infection was from a vaccine strain or wild-type measles virus.  Not a single American has died from measles since.

We need to know if vulnerable, immunocompromised children are catching and dying from vaccine-preventable diseases, and from whom they are catching these diseases:  from the vaccinated, from the unvaccinated, or from their own latent viruses?  From vaccine strains or wild-type infections?

How many children are affected?  Where are they?  Which diseases are killing them? I am not finding evidence of a problem in the medical literature.

Before we "fix" it, can someone describe the dimensions of this problem? Does this problem even exist?  



[1] Portland Press Herald http://www.pressherald.com/2015/05/10/a-maine-teen-has-to-ask-is-everyone-in-this-room-vaccinated/
[2] Vermont Public Radio http://digital.vpr.net/post/passions-flare-hearing-proposal-eliminate-philosophical-exemption
[3] http://www.jhoonline.org/content/pdf/1756-8722-6-94.pdf
[4] http://cdn.intechopen.com/pdfs-wm/39664.pdf
[5] http://www.jhoonline.org/content/pdf/1756-8722-6-94.pdf
[6] http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
[7] http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm

Sunday, April 26, 2015

Why Would You Vaccinate a Newborn for Hepatitis B?

My maternal grandfather died in 1968 of what was almost certainly a fulminant Hepatitis B infection (causing rapid liver failure, occurring in just 1% of acute cases). He probably acquired it working part-time in a deli, slicing meat. In med school a few years later, I learned that butchers had increased risk. You get Hepatitis B from blood (needle sharing, needlesticks) and sex. And very rarely from activities where blood from an infected person can contaminate a fresh cut. A newborn can catch it from its mother, too.

When I was an intern I treated a young prisoner who had been an intravenous drug abuser and had both bacterial endocarditis with an acutely flailing mitral valve and active Hepatitis B. We learned this when a nurse got a needlestick.  His terrible heart failure led to bloody pulmonary discharge sprayed on us all. We were lucky to keep him alive, struggling over him all night, until he had surgery for a valve replacement the next day. 


His treatment team was offered the new Hepatitis B vaccine, made from pooled blood (no longer used) and Hepatitis B immune globulin (also made from pooled blood, still used occasionally). I accepted both. After all, I might have a genetic predisposition to fulminant Hepatitis B. I even paid cash for the vaccine. I weighed the benefit and risk, and the vaccine won.


Now it is 2015 and I am expecting twin grandchildren, a boy and a girl, in July. If a bill passes the Vermont House (it already passed the Senate), they will both receive a dose of Hepatitis B vaccine on the day of birth... if they hope to attend day care, or any public or private school in Vermont. 


Since we do not expect them to use a meat slicer, have sex or play with dirty needles, what could the reason for vaccination at this age possibly be? All moms are screened (99% screening rate in New Hampshire for expectant moms) so an infected Mom is unlikely to slip through the cracks.  An infected mom and her newborn need not only the vaccine, but also immune globulin, and possibly an antiviral drug. So vaccinating all babies does not provide adequate treatment for those who really need it.


When newer Hepatitis B vaccines became available, they were recommended only for those at high risk.  But many high risk individuals did not choose to be vaccinated.  


So the decision was made to instead vaccinate infants.  Infants may be at infinitesimal risk, but they will eventually grow to an age where their risk increases. They are a captive audience. Infants can't say "no" to a vaccine, like their parents can, and do. It makes sense, I guess, if your goal is to reduce numbers of cases using the most easily-imposed route.  It makes some sense at the population level. It makes sense if there are almost no side effects from the vaccine.


But what if there are side effects? Babies cannot tell you if they are experiencing a side effect. What if the birth dose contributes to later childhood neurologic problems in those who are susceptible?


When your new baby is vaccinated on the day of birth, you don't know what that child might have been like, without being vaccinated. You cannot compare "before" and "after." You cannot easily determine what is a side effect from that very first dose of vaccine. A colleague of mine, who had access to vast amounts of unpublished data on this vaccine as an expert for the French government, wrote about the difficulty of acknowledging and understanding the vaccine's adverse reactions, when so much important information has never been published.


Below, CDC maps out the chronology of its Hepatitis B vaccine program's 20 year mission creep, from recommendations for those who really needed it, to those who clearly do not:

Table 1

Even before CDC recommended that all babies be vaccinated, in 1990, there were less than 2 new Hepatitis B cases per 100,000 per year, in US children under age 15. From CDC:

Figure 1
We are vaccinating 5 million newborns yearly to prevent a disease that occurs in less than 25 children aged 0-12 months each year.  In fact, the vast majority of vaccinated children are at zero risk of the disease. According to CDC, among all US children aged 0-19 years, in 2002 there were only 3 new cases per million children annually.


The public health goal, presumably, is to have children immune by the time they becomes sexually active or at risk from needles. Yet one CDC study showed that half the children vaccinated starting at birth, with 3 doses, lost immunity after 15 years. So early vaccination is illogical, if what you seek is for babies to retain immunity into adolescence and adulthood. For that, they should be vaccinated later.


Absent an infected mother (less than 0.5% of new moms), it makes no scientific sense to vaccinate every baby on the first day of life. And because babies cannot spread this virus to each other (there is no oral-fecal spread for this type of hepatitis virus) you cannot justify vaccinations to improve herd immunity. 


The only possible justification for a vaccine mandate is to protect other children.  In this case, certainly for children under fifteen, other children gain no protection and the mandate is unreasonable and unwarranted. 

Saturday, April 18, 2015

DPT vaccine: Is your child at risk from unvaccinated children?/ CDC

Let's start with tetanus, the disease we think of when scratched with something rusty or dirty. This is a terrible illness, because tetanus bacteria produce a nerve toxin that takes months to recover from.  

First, how much tetanus is there is the US?  Second, does it spread from person-to-person? There are about 30 cases and 4 deaths per year in the US. Most cases occur in those over 35 years old.  Tetanus comes from a wound.  it does not spread from one person to another.


Tetanus - United States, 1980-2009

graph showing tetanus cases by year (1980-2009) as discussed in the Secular trends in the united states section

Diphtheria - United States, 1980-2009

Diphtheria - United States, 1980-2009, chart of secular trends, explained under the secular trends in the United States section.

What about diphtheria? Since 1980, there have been 5 or less US cases yearly per CDC's chart, above. You child will virtually never be exposed.  But here is a surprise from the medical textbook "UpToDate". The vaccine is not that effective, since it immunizes against a toxin but not against growth of the bacteria that produce the toxin:

"Asymptomatic carriers are important for transmission of diphtheria. Immunity (either via natural infection or vaccine-induced) does not prevent carriage. In areas of endemicity, up to 5 percent of healthy individuals may have positive pharyngeal cultures... As the general population becomes immune, there are fewer cases of clinical diphtheria (from toxigenic strains) and less asymptomatic colonization with toxigenic strains and therefore decreased transmission to nonimmune people. However, there does not appear to be any reduction in the prevalence of carriers of non-toxigenic C. diphtheriae. Immunized individuals can develop clinical diphtheria, although disease is less severe and occurs less frequently."
So we are currently protected by the low level of toxin-producing diphtheria strains in the environment, and only to a degree by the vaccine itself. By serology, 91% of children aged 6-11 had protective diphtheria antibodies, but only 30% of adults over 70 had protective antibodies.  If we were worried about plugging immune "holes" we would start vaccinating adults, not children. But we don't need to, because the environment protects us from diphtheria, with help from the vaccine, in today's era. See this abstract from the US Center for Health Statistics, 2002:


 2002 May 7;136(9):660-6.

Serologic Immunity to Tetanus and Diphtheria in the US
McQuillan GM1Kruszon-Moran DDeforest AChu SYWharton M

  • 1Division of Health Examination Statistics, National Center for Health Statistics, Hyattsville, MD 20782, USA. gmm2@cdc.gov

Abstract

BACKGROUND:

Serologic data on diseases that are preventable by vaccine are useful to evaluate the success of immunization programs and to identify susceptible subgroups.

OBJECTIVE:

To provide national estimates of immunity to diphtheria and tetanus by measurement of serum antibody levels.

DESIGN:

Examination of data from the Third National Health and Nutrition Examination Survey, a representative cross-sectional sample of the U.S. population.

SETTING:

89 randomly selected locations throughout the United States.

PARTICIPANTS:

18 045 persons 6 years of age or older who were examined from 1988 to 1994.

MEASUREMENTS:

Serum samples obtained at a single time point were tested for diphtheria and tetanus antitoxin.

RESULTS:

Overall, 60.5% of Americans 6 years of age or older had fully protective levels of diphtheria antibody (> or =0.10 IU/mL) and 72.3% had protective levels of tetanus antibody (> 0.15 IU/mL). Ninety-one percent of Americans 6 to 11 years of age had protective levels of both diphtheria and tetanus antibody; this proportion decreased to approximately 30% among persons 70 years of age (29.5% for diphtheria and 31.0% for tetanus). Adult Mexican-Americans were slightly less likely to have protective levels of antibody to both toxins. Only 47% of persons 20 years of age or older had levels that were protective against both diseases, and only 63% of adults who were protected against tetanus were also protected against diphtheria.

CONCLUSIONS:

A substantial proportion of adults in the United States do not have antibody levels that are protective against diphtheria and tetanus. In addition, although the recommended vaccine is a combination of tetanus and diphtheria, only 63% of adults with protective antibody to tetanus also had protective antibody to diphtheria.
----------------------------------------------------------------
Pertussis has re-emerged in the US due to several vaccine failures, particularly because the vaccinated can spread it, while experiencing only minor illness.  


The first failure was the low efficacy of the former DPT ("whole cell pertussis") vaccine. Even though CDC admits the DTP vaccine was only 70-90% effective after 4 doses for pertussis, diagnosed pertussis cases dropped dramatically in the US during its period of use. But then they resurged, beginning in the 1970s. [Most cases were not diagnosed and reported, since diagnosis required special culture media, and if there had been antibiotic treatment, cultures were generally negative. I and other clinicians have treated a lot of presumed pertussis cases over the last 30 years. There are no reliable case counts. But the trends are accurate, in my view.]
Pertussis - United States, 1940-2009
graph showing Pertussis cases by year (1940-2009) as discussed in the Secular trends in the united states section

Pertussis - United States, 1980-2009

graph showing Pertussis cases by year (1980-2009) as discussed in the Secular trends in the united states section

The second failure was the pertussis vaccine's toxicity: it caused a high rate of seizures and other neurological reactions in children. Once this was acknowledged, a less toxic acellular pertussis component was used in US vaccines, beginning in 1992. 

CDC expected the new vaccine to be both safer and more effective than the older vaccine.  CDC notes:

"When studied, the [new] acellular pertussis vaccine was significantlymore effective than whole-cell DTP in preventing serious pertussis disease. Protection decreased with time, resulting in little or no protection 5 to 10 years following the last dose."

Drugs and vaccines always look more effective in pre-

licensure trials (sponsored by their manufacturers) than they appear later. Although less toxic, the newer vaccine turned out to be less, not more, effective. Not only did protection wane fairly rapidly; the newer vaccine (compared to the former vaccine) enhanced spread of Bordetella pertussis, according to FDA. From UpToDate:

"...several reports suggest that the immunity following administration of the fifth DTaP dose wanes more rapidly than expected, leaving a gap in immunity between the last childhood dose of DTaP and the Tdap (6th dose) booster vaccine (suggested age of administration at 11 to 12 years of age). Adolescents who received the childhood DTaP vaccine appear to have a substantially higher risk of contracting pertussis than those who received the DTwP [older] vaccine." 
Despite recommending 2 extra DPT doses (for adolescents and adults) for the vaccine schedule in 2005, CDC recommended that all close contacts of a case of pertussis take prophylactic antibiotics. Close contact includes being in the same room as someone with pertussis for a prolonged period, such as in your child's schoolroom. It seems even with six doses by age twelve the pertussis vaccine is unreliable.

Here's the bottom line: the tetanus component of current DTP vaccines seems to work reasonably well, while both diphtheria and pertussis components offer less protection than desired. They reduce severity but do not prevent infections well; they allow the vaccinated to spread disease, and the protection (certainly for pertussis, and serologically for diphtheria) wears off over several years. A safer and more effective vaccine for pertussis, and a more effective diphtheria vaccine, are needed.

Thursday, April 16, 2015

WHO takes a stand for transparency in clinical trials research / Science

Pharmaceutical companies conduct pre-clinical (without people) and clinical research (utilizing human subjects) to understand the effects of drugs they are developing. Until now, even though the research often involves human voluntary subjects who may not be compensated for their participation, the findings of the research have been considered proprietary, or owned by the research sponsor.  As proprietary data, the owner could do with it what it wanted.  It the results were unwelcome, the whole trial could be buried.

Alternatively, the results could be spun, massaged or misleadingly presented--as there is no law that requires companies to reveal their raw data for independent analysis.

Then we all lose, as the information available about how to use drugs may be untrue. I will mis-prescribe, and you will fail to get the intended benefit, or be subject to greater risk of adverse reactions than we knew.

Many find this intolerable, especially since human volunteers take health risks to generate these data.  Why should the risk be theirs, and all benefit accrue to the Pharma sponsor?

From Science
The movement to ensure that clinical trial results don't end up in drawers has found an important global ally. Today, the World Health Organization (WHO) issued a call to make results from every clinical study publicly available within a year. Not doing so can harm patients and research subjects, waste time and money, and hold back medical science, WHO says.
“Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions,” said Marie-Paule Kieny, an assistant-director at WHO, in a press statement today. “It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.”
Clinical trials go unpublished for a variety of reasons. Sometimes a study's sponsor prefers not to call attention to unwelcome results; sometimes researchers have trouble getting a journal to print their findings—for instance if they show a treatment had no effect; and sometimes scientists never get around to writing a manuscript. But withholding results leads to "publication bias," which causes treatments to seem more or less effective than they really are, and it can put volunteers in future trials at risk unnecessarily.
In its statement, WHO says that from now on the main findings of every clinical study should be submitted to a peer-reviewed journal within 12 months after data collection ends and be published—in an open-access journal unless there is a specific reason why that's impossible—within 24 months. "Main findings" may sound rather limited, but actually includes everything from trial design and eligibility criteria to the outcomes, limitations, and interpretation of a study. WHO refers researchers who want a checklist of what needs to be in a paper to the so-called CONSORT statement.
In addition, WHO wants the "key outcomes"—a more limited data set including number of participants, key results, and adverse events—made available in a clinical trial registry such asClinicalTrials.gov within 12 months after a study is completed. WHO also calls on the publication of the results from older studies that have never seen the light of day.
"It's unethical to conduct clinical research without reporting the results," says Vasee Moorthy, an author of a paper about the new statement published in PLOS Medicine today. Europe and the United States have already made important regulatory strides to registering trials and making their outcomes public, Moorthy says; he hopes WHO's statement will stimulate countries elsewhere to do the same.
Ben Goldacre, a co-founder of the advocacy group AllTrials, praises WHO's "landmark position statement" in another paper in PLOS Medicine, but says it's not enough. To make sure that researchers follow WHO's advice and fulfill their reporting obligations, Goldacre recommends independently conducted audits. For every trial entered in a trial registry more than 12 months ago, auditors can simply check whether the results have been published and post their findings. That "would allow us to name and shame poor performers, and also to reward best practice," Goldacre writes.
The requirement to publish in an academic journal may prove a red herring, Goldacre says, as journal articles are sometimes incomplete, wrong, or full of spin, and publication can take a long time. Reporting results in a structured database like ClinicalTrials.gov is speedier and often better, he argues.

Friday, April 10, 2015

When FDA inspections of clinical trials discover actionable research misconduct, how is the public notified? It isn't / JAMA IM

 2015 Apr 1;175(4):567-77. doi: 10.1001/jamainternmed.2014.7774.

Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.

Abstract

IMPORTANCE:

Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.

OBJECTIVES:

To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.

DESIGN AND SETTING:

Cross-sectional analysis of publicly available documents, dated from January 1, 1998, to September 30, 2013, describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found.

MAIN OUTCOMES AND MEASURES:

For each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified.

RESULTS:

Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate record-keeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.

CONCLUSIONS AND RELEVANCE:

When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

Thursday, April 9, 2015

Vaccines are very profitable today/ Atlantic

In that same panel on vaccines, another panelist alleged that vaccines are a low-margin product and a low profit industry.  It was said that many companies left the market.

That was true once.  This is now.  There are few companies due to tremendous market consolidation in pharmaceutical companies overall. Prices of vaccines have gone crazy. Almost all new vaccines in the US cost over $100 per dose.  The rise of third-party payers (mostly the federal government) made this possible.

From the Atlantic, regarding changes to the industry:
... But then a couple things happened to turn the vaccine market around in recent years. Global demand, particularly in developing countries, shot up. Since 2000,the Gavi Alliance has provided vaccination for 500 million children in poor countries, preventing an estimated 7 million deaths. GlaxoSmithKline reportedthat 80 percent of the vaccine doses they manufactured in 2013 went to developing countries. Additionally, vaccines that could turn a profit in high-income countries—constituting 82 percent of global vaccine sales in terms of value, according to the World Health Organization—hit the market.
"I think the market opened up once Hepatitis B vaccine showed that you can really sustain very high prices for single dose. That was unheard of back in the 1980s," says David Bishai, director of the Interdepartmental Health Economics Program at Johns Hopkins Bloomberg School of Public Health.
Two "blockbuster" vaccines also hit the market: pneumococcal conjugate for meningitis and other bacteria infections, and a vaccine for human papillomavirus (HPV). The industry grew. One estimate puts the vaccine market now at $24 billion—huge, but a mere 2 to 3 percent of a trillion-dollar worldwide pharmaceutical industry.
While vaccine prices have always been higher in the U.S. and Europe due to tiered pricing, prices have been rising dramatically in recent years. The government's Vaccine for Children Program purchases vaccines for about 50 percent of children in the U.S. The current CDC pediatric-contract price for MMR is $19.91, while the private-sector pediatric price for MMR has risen to $59.91. [Merck scientists have alleged Merck faked data on the mumps component of MMR to make it appear more effective than it is--Nass.]
In the U.S., Merck is the only company licensed to offer the measles vaccine. In their recent 2014 earnings report, they reported that sales of ProdQuad (a vaccine for measles, mumps, rubella, and varicella), MMR II (for measles, mumps, rubella), and Varivax (a chicken pox vaccine) together came in at $1.4 billion, a fraction of the company's $42.2 billion in global sales. Their top selling vaccine is Gardasil, an HPV vaccine, which brings in $1.7 billion in sales... 

Has Merck formed an unholy alliance with influential medical journals, as well as with CDC?

Yesterday I was in a televised panel discussion about vaccines, and I suggested that Merck might influence CDC by donating to CDC's foundation and by having hired CDC's former Director, Julie Gerberding, as President of Merck Vaccines.  After NJ's Health Director Eddie Bresnitz mandated Merck's HPV vaccine in NJ, he too was given a job at Merck. Merck donated to Texas governor Rick Perry, both directly and when he was head of the Republican Governors' Association, so the largest share did not technically count as going to him.  Perry mandated HPV for Texas' girls. [Texas' legislature later voted down his mandate.]

Merck has also made donations to national organizations of state legislators to support "educational programs" that supported vaccine mandates at the state level for Merck vaccines.  From the WaPo:
"One of [Gov. Rick] Perry’s closest confidantes, his former chief of staff Mike Toomey, was then working as an Austin-based lobbyist for Merck, which was in the midst of a multimillion-dollar campaign to persuade states to make the vaccine mandatory."
Then there is the issue of Merck faking its data on its Mumps vaccine, making it seem more effective than it really is. Merck has been charged by its own scientists over this. While public health officials blamed vaccine refusers for recent mumps outbreaks, it seems the greater culprit was poor vaccine protection.

Another panel member challenged my statements about Merck and public officials as "grand conspiracy theory."  Who needs conspiracies, when the facts tell the story? Let's look instead at some additional Merck murkiness, uncovered by my colleague Vera Sharav and others: 

http://www.ahrp.org/cms/content/view/766/9/


BMJ and Lancet Wedded to Merck CME Partnership


Monday, 14 February 2011

Why did the BMJ fail to disclose its partnership agreement with Merck,, a major vaccine manufacturer--13 vaccines, including the controversial MMR vaccine ? 

Is it just conceivably possible, that the BMJ's decision to commission and publish Brian Deer's series of articles attacking Dr. Andrew Wakefield's personal and scientific integrity--and lend its unwavering editorial endorsement--without giving him an opportunity to defend himself--might be influenced by a SIGNIFICANT financial conflict of interest?
The discovery that a psychiatry textbook penned by two influential academics who gained notoriety, was actually ghostwritten shocked Dr. David Kessler, former commissioner of the FDA, who called it "a new level of chutzpah [that] takes your breath away."
How about the discovery that in 2008, the pharmaceutical giant, Merck--using its tradename, MSD signed a partnership agreement  with the BMJ Group that effectively gave the company control of 350 interactive continuing medical education courses in over 20 medical therapy areas?
"This unique partnership will change the face of medical education in Europe and beyond, allowing users access to most of BMJ Learning's library of 'Continuing Medical Education' (CME) and 'Continuing Professional Development' (CPD) content. The agreement between MSD and BMJ Group comprises about 350 interactive learning courses in over 20 medical therapy areas."
Why did the BMJ fail to disclose its partnership agreement with Merck?
Why did the BMJ conceal from readers-- of the Brian Deer series of articles and the BMJ editorial excoriating Dr. Andrew Wakefield, charging him with deliberate fraud and financial conflict of interest-- the fact that the BMJ had a partnership with Merck, a major manufacturer of vaccines--including the MMR vaccine, which is at the center of the Wakefield controversy? 
In 2009, Univadis, a Merck trademark, entered into a partnership with The Lancet providing "medical education and an information website."
 "Through a unique global medical literature service called Just Published, clinical specialists registered on Univadis ®will receive free access to the full text of recently published articles from The Lancet.  This new service will be available on www.univadis.com  
I don't think it a stretch to suggest--as Martin Walker does (below) that: 
"Linking Univadis ® /Merck with the BMJ and The Lancet inevitably links them both to Merck's VIS (Vaccine Information Service) online — 'a comprehensive source of information, especially designed to provide healthcare professionals with the answers to their questions on vaccines.'"
The fact that BMJ and The Lancet-- two of the most prestigious international medical journals would enter into a medical education partnership with the drug manufacturer whose staff drew up a "doctor hit list" to intimidate doctors who dared to discuss the lethal cardiac risks linked to Vioxx--is in itself a betrayal of trust of the worst sort.
The stated purpose of the Merck / BMJ/ Lancet partnerships that remained hidden from readers' view, is to "change the face of medical education in Europe and beyond." 
The BMJ editorial accompanying Deer's articles, did its best to lend authority to the vaccine industry (Merck's) perspective. In an introductory sound bite the editors declare: 
"Clear evidence of falsification of data should now close the door on this damaging vaccine scare."
Finally, the  Statement about Competing Interests at the end of the BMJ Editorial claims compliance with conflict of interest disclosure requirements of the International Committee of Medical Journal Editors. But the BMJ editor in chief and two deputy editors conceal rather than disclose the most relevant financial conflict of interest:
"Competing interests: All authors have completed the Unified Competing Interest form atwww.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years
  
Vera Hassner Sharav

Merck Vaccines for Children: :

AFLURIA®
 (Influenza Virus Vaccine)
COMVAX® 
[Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] 
GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 
M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live) 
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] 
PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 
ProQuad® (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live)
RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) 
Tetanus and Diphtheria Toxoids Adsorbed 
VAQTA® (Hepatitis A Vaccine, Inactivated) 
VARIVAX® (Varicella Virus Vaccine Live) 
ZOSTAVAX® (Zoster Vaccine Live)

Tuesday, April 7, 2015

FBI's AMERITHRAX Case just unravelled. Ex-FBI agent who directed investigation suing FBI, turns whistleblower!!!

Here is the Complaint, filed on April 2, 2015 alleging gross mishandling of the case on many levels, and concealment of evidence exonerating Bruce Ivins:

http://www.documentcloud.org/documents/1714250-former-fbi-special-agent-in-charge-richard.html  

Here is the story in the NY Times of April 8. Here is the story in Courthouse News.

And here are some extraordinary excerpts from the complaint that validate things I have previously pointed out:

5. This complaint further details how Defendants’ derelict failure to perform their mandated legal duties to Plaintiff was driven by Defendants’ blinding animus toward Plaintiff for Plaintiff’s prior whistleblower reports of FBI and DOJ mismanagement of the FBI’s investigation into the anthrax attacks of 2001 (code named “AMERITHRAX”).

From pages 23 to 25:

50. In the fall of 2001, following the 9/11 attacks, a series of anthrax mailings occurred which killed five Americans and sickened 17 others. Four anthrax-laden envelopes were recovered which were addressed to two news media outlets in New York City (the New York Post and Tom Brokaw at NBC) and two senators in Washington D.C. (Patrick Leahy and Tom Daschle). The anthrax letters addressed to New York were mailed on September 18, 2001, just seven days after the 9/11 attacks. The letters addressed to the senators were mailed 21 days later on October 9, 2001. A fifth mailing of anthrax is believed to have been directed to American Media, Inc. (AMI) in Boca Raton, Florida based upon the death of one AMI employee from anthrax poisoning and heavy spore contamination in the building.

51. Executive management at FBI Headquarters assigned responsibility for the anthrax investigation (code named “AMERITHRAX”) to the Washington Field Office (WFO), dubbing it the single most important case in the FBI at that time.

52. In October 2002, in the wake of surging media criticism, White House impatience with a seeming lack of investigative progress by WFO, and a concerned Congress that was considering revoking the FBI’s charter to investigate terrorism cases, Defendant FBI Director Mueller reassigned Plaintiff from the FBI’s San Diego Field Office to the Inspection Division at FBI Headquarters and placed Plaintiff in charge of the AMERITHRAX case as an “Inspector.”While leading the investigation for the next four years, Plaintiff’s efforts to advance the case met with intransigence from WFO’s executive management, apathy and error from the FBI Laboratory, politically motivated communication embargos from FBI Headquarters, and yet another preceding and equally erroneous legal opinion from Defendant Kelley – all of which greatly obstructed and impeded the investigation.

53. On July 6, 2006, Plaintiff provided a whistleblower report of mismanagement to the FBI’s Deputy Director pursuant to Title 5, United States Code, Section 2303. Reports of mismanagement conveyed in writing and orally included: (a) WFO’s persistent understaffing of the AMERITHRAX investigation; (b) the threat of WFO’s Agent in charge to retaliate if Plaintiff disclosed the understaffing to FBI Headquarters; (c) WFO’s insistence on staffing the AMERITHRAX investigation principally with new Agents recently graduated from the FBI Academy resulting in an average investigative tenure of 18 months with 12 of 20 Agents assigned to the case having no prior investigative experience at all; (d) WFO’s eviction of the AMERITHRAX Task Force from the WFO building in downtown Washington and its relegation to Tysons Corner, Virginia to free up space for Attorney General Ashcroft’s new pornography squads; (e) FBI Director’s Mueller’s mandate to Plaintiff to “compartmentalize” the AMERITHRAX investigation by stove piping the flow of case information and walling off task force members from those aspects of the case not specifically assigned to them – a move intended to stem the tide of anonymous media leaks by government officials regarding details of the investigation. This sequestration edict decimated morale and proved unnecessary in light of subsequent civil litigation which established that the media leaks were attributable to the United States Attorney for the District of the District of Columbia and to a Supervisory Special Agent in the FBI’s National Press Office, not to investigators on the AMERITHRAX Task Force; (f) WFO’s diversion and transfer of two Ph.D. Microbiologist Special Agents from their key roles in the investigation to fill billets for an 18 month Arabic language training program in Israel; (g) the FBI Laboratory’s deliberate concealment from the Task Force of its discovery of human DNA on the anthrax-laden envelope addressed to Senator Leahy and the Lab’s initial refusal to perform comparison testing; (h) the FBI Laboratory’s refusal to provide timely and adequate scientific analyses and forensic examinations in support of the investigation; (i) Defendant Kelley’s erroneous and subsequently quashed legal opinion that regulations of the Occupational Safety and Health Administration (OSHA) precluded the Task Force’s collection of evidence in overseas venues; (j) the FBI’s fingering of Bruce Ivins as the anthrax mailer; and, (k) the FBI’s subsequent efforts to railroad the prosecution of Ivins in the face of daunting exculpatory evidence. Following the announcement of its circumstantial case against Ivins, Defendants DOJ and FBI crafted an elaborate perception management campaign to bolster their assertion of Ivins’ guilt. These efforts included press conferences and highly selective evidentiary presentations which were replete with material omissions. Plaintiff further objected to the FBI’s ordering of Plaintiff not to speak with the staff of the CBS television news magazine 60 Minutes or investigative journalist David Willman, after both requested authorization to interview Plaintiff.

54. In April 2008, some of Plaintiff’s foregoing whistleblower reports were profiled on the CBS television show 60 Minutes. This 60 Minutes segment was critical of FBI executive management’s handling of the AMERITHRAX investigation, resulting in the agency’s embarrassment and the introduction of legislative bills calling for the establishment of
congressional inquiries and special commissions to examine these issues – a level of scrutiny the FBI’s Ivins attribution could not withstand.

55. After leaving the AMERITHRAX investigation in 2006, Plaintiff continued to publicly opine that the quantum of circumstantial evidence against Bruce Ivins was not adequate to satisfy the proof-beyond-a-reasonable doubt threshold required to secure a criminal conviction in federal court. Plaintiff continued to advocate that while Bruce Ivins may have been the anthrax mailer, there is a wealth of exculpatory evidence to the contrary which the FBI continues to conceal from Congress and the American people. The FBI vehemently opposes Plaintiff’s position.
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Here is the FBI's report (from 2011) about the enormous resources it expended on this case:
"Over the course of the investigation, the FBI and the Postal Inspection Service devoted 600,000 investigator work hours to the case and assigned 17 special agents to a task force, along with 10 U.S. Postal Inspectors. The investigation spanned six continents; involved over 10,000 witness interviews, 80 searches, 26,000 e-mail reviews, and analyses of 4 million megabytes of computer memory; and resulted in the issuance of 5,750 grand jury subpoenas. Additionally, 29 government, university, and commercial laboratories assisted in conducting the scientific analyses that were an important aspect of the investigation."