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. 




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 A colleague of mine, who had access to vast amounts of unpublished data on this vaccine as an expert for the French government, wrote about the difficulty of acknowledging and understanding the vaccine's adverse reactions,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 4 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.  But there may be many fewer cases even than this number.  A
ccording to medical reference UpToDate by 2007, the incidence of acute hepatitis B in children  less than 15 years old had fallen to 1 in 5 million per year. Furthermore, UpToDate tells us, “The majority of [US] children with chronic HBV infections are immigrants, have immigrant parents, or became exposed through other household contacts.”  And the majority of new cases in childhood are in children not born in the US.

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. 

A Cochrane meta-analysis found that "the prevalence of anti-HBs seroconversion by rapid vaccination (0, 1, and 2 months) was significantly lower than that by standard vaccination (0, 1, and 6 months).  If giving the third Hep B vaccine dose later results in better immunity, it is perhaps likely that giving the first 2 shots later would improve immunity. Two studies (here and here) showed non-detectable Hep B antibody levels 6-10 years later in nearly 50% of children who were vaccinated starting at birth, though most did show evidence of immune memory when given a booster dose.  But it would be preferable to have persisting high antibody levels, in addition to immune lymphocytes, if vaccinated children were later exposed to the hepatitis B virus.  Likely this would be better achieved by starting vaccinations in low-risk children at an older age, or not at all, as many other countries do.

Vaccinating at birth is illogical for low-risk babies, if what you seek is to retain immunity into adolescence and adulthood. For that, they should be vaccinated later.

UPDATE:  Is giving  dose of hepatitis B vaccine on the day a child is born, to children whose mothers are negative and have no risk factors,  a standard procedure in other countries?  Of course not.  The European Center for Disease Prevention and Control lists the vaccine schedule for each of the countries in Europe. Only 5 of the 31 European countries (Estonia, Lithuania, Poland, Portugal and Romania) recommend a hepatitis B vaccination for even low-risk babies at birth.

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 of those at extremely low risk of the disease to protect other children.

UPDATE:  The only possible legal and ethical justification for a vaccine mandate is to protect the public:  in this case, other children.  Why else would laws be enacted to prevent uninfected but unvaccinated children from attending school? (Remember: infected children are not prevented from attending school!)  Since the hepatitis B vaccine fails this standard, it seems the primary protection the Hepatitis B vaccine mandate provides is to the vaccine manufacturers' profits.

Saturday, April 18, 2015




Tetanus - United States, 1947-2008

* Per 1 million population.

Diphtheria - United States, 1980-2011



 2002 May 7;136(9):660-6.

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










89 randomly selected locations throughout the United States.









Pertussis - United States, 1950-2010 




Drugs and vaccines always look more effective in pre-




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 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 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.















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:
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:

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  
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 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." 
Vera Hassner Sharav

Merck Vaccines for Children: :

 (Influenza Virus Vaccine)
PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 
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 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:


From pages 23 to 25:





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.

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."

Sunday, April 5, 2015

CDC's too-early measles vaccination rule has left millions of vaccinated Americans without protection/ Pediatrics


But in the United States, endemic measles has been eliminated. It does not circulate here, except when a case arrives from overseas. Yet here too, the recommended age for a first measles vaccine has been changed over time. It used to be 15 months; now it is 12 months.

Actually, measles is not endemic anywhere in the Americas (yes, the entire Western Hemisphere) because public health agencies, especially the Pan American Health Organization, have vaccinated children in the farthest reaches of Latin America. The public health systems have done a great job of controlling the spread of measles cases, when they appear from overseas. Even in the poorest countries of our hemisphere, measles (as well as mumps and rubella) has not reestablished endemicity. [And, since Third World countries have handily controlled the spread of measles measles, one expects the CDC to have no difficulty doing the same here.]

The only way to absolutely prevent all measles cases is to close your borders, and no one suggests doing that. Fewer than one person per million in the Western Hemisphere gets measles each year. 

In Europe, Africa and Asia the measles situation is different. But we are here.

It has long been known that the younger you are when you receive a measles vaccine, the less likely you are to achieve immunity. For example, in a 1978 CDC article published in the journal Pediatrics, Walter Orenstein (later director of the US National Immunization Program) et al. wrote:

It's remarkable: children vaccinated at 12-14 months were at 19 times the risk of measles vaccine failure (i.e., catching measles) as those vaccinated at 15 months.
This lesson was not forgotten.  

Here is CDC 's 1989 acknowledgement that it increased the age for MMR to 15 months to improve effectiveness:
In 1963, the recommended age for vaccination was 9 months, but in 1965 it was changed to 12 months, and in 1976 it was changed to 15 months because of evidence demonstrating greater efficacy when children were vaccinated at these ages. Persons vaccinated before the first birthday needed to be revaccinated.
As recently as 2013 CDC noted:
This range of [measles vaccine] effectiveness also can be attributed to age at vaccination (i.e., the 85% vaccine effectiveness represented children vaccinated at age 12 months, whereas the ≥94% vaccine effectiveness represented children vaccinated at age ≥15 months.
What may be less well known is that if you receive your first measles vaccination at a young age, you are probably less likely to gain strong immunity from subsequent doses of measles vaccine, compared to those who received their initial measles vaccine at a later age.

Canada had a large measles outbreak in 2011.  There were over 750 cases in the province of Quebec alone, five times as many cases as the Disneyland epidemic.  

In a study of one school which had 110 measles cases, about half the children who developed measles had received two or more MMR doses, and about half were unvaccinated.

In efforts to understand the high rate of vaccine failure, it was found that children in the school who received their first MMR dose between 12-14 months had a vaccine failure rate of 7%, while children who received their first dose at 15 months or older had a vaccine failure rate of only 2.5%.

"An unexpected finding from this outbreak investigation was that in 2-dose recipients, VE [vaccine efficacy] was greater with older age at first dose, from 93% at 12 months to 97.5% at 15 months. The risk of measles was 2 to 4 times greater when children were first vaccinated between 12 and 14 months versus 15 months. Older age at the second dose or longer interval between doses did not influence this observation."
This Canadian government study concluded:
"Although unvaccinated people should remain the prime target for measles vaccination, the unexpected vulnerability we have identified in twice vaccinated people could ultimately lead to failed measles elimination efforts. If the effect of early vaccination permanently alters the ability to respond to subsequent doses, even adding a third or fourth dose may not provide long-lasting protection. Therefore, it is critical to understand the mechanisms of primary vaccine failure or loss of vaccine protection that our findings may signal."
The US is not like Africa when it comes to measles. No babies have died from measles in the US for more than 15 years. We can afford to wait a few months to give the first MMR dose, and optimize vaccine-induced protection for our children. If we are going to take the risks inherent in using any vaccine or drug, we owe it to ourselves to maximize the benefits we can gain from them.

Delaying the MMR for 3 months appears to be a much more effective way to optimize herd immunity than increasing the number of doses, or reducing exemptions. CDC surely knows its directive to give the MMR at 12 months has increased the number of vaccinated Americans susceptible to measles, probably several-fold. Why hasn't CDC acted on this knowledge, and revised the age for giving the first MMR?

In fact, were it to do so, there might not even be a need for the second MMR, according to Orenstein's 1978 article.

Instead of admitting this problem and moving forward,
"... here's what director of CDC's National Center for Immunization and Respiratory Diseases Anne Schuchat had to say last month: "This is not a problem of the measles vaccine not working. It's a problem of the measles vaccine not being used." She also said, "There's no harm in getting another MMR (measles, mumps and rubella) vaccine."'
Might Dr. Anne Schuchat not know what Dr. Walter Orenstein and others at CDC know about the best age to start MMR?  It's not likely, because they worked together at CDC for many years; because each has been the director of the National Immunization Program; and furthermore, because they have co-written several articles on vaccines.* 

But note the incestuous relationship between CDC and Merck:
CDC has ignored its own measles vaccine science, with increased vaccine sales but reduced population immunity the result.  Which begs the question: who do CDC and Dr. Schuchat really work for?  

After a number of separate lab mishaps at CDC that exposed scientists (with no knowledge or warning) to live bird flu, anthrax and Ebola, CDC's director had an advisory committee look into the matter.  In January, the committee concluded that CDC lacked a "culture of safety."  Given all the above, should we be blindly taking CDC's advice? **  

Instead, a CDC housecleaning is in order, with the goal of promoting the development of more effective and safer ways to vaccinate.

*  In addition to serving on the National Vaccine Advisory Committee together, Drs. Schuchat and Orenstein have co-authored the following papers:

  1. Vaccine-preventable diseases, immunizations, and the Epidemic Intelligence Service. Hinman AR, Orenstein WA, Schuchat A. Am J Epidemiol. 2011 Dec 1;174(11 Suppl):S16-22.
  2. Vaccine-preventable diseases, immunizations, and MMWR--1961-2011. Hinman AR, Orenstein WA, Schuchat A; Centers for Disease Control and Prevention (CDC). MMWR Surveill Summ. 2011 Oct 7;60 Suppl 4:49-57.
  3. Incidence of macrolide resistance in Streptococcus pneumoniae after introduction of the pneumococcal conjugate vaccine: population-based assessment. Stephens DS, Zughaier SM, Whitney CG, Baughman WS, Barker L, Gay K, Jackson D, Orenstein WA, Arnold K, Schuchat A, Farley MM; Georgia Emerging Infections Program. Lancet. 2005 Mar 5-11;365(9462):855-63.
**  CDC lacks a culture of safety.  Just 3 months ago, an advisory committee to the CDC Director issued its recommendations to improve safety at CDC.  The report began with the following words: "Observation: Leadership commitment toward safety has been inconsistent and insufficient at multiple levels. Safety, including lab safety, is viewed by many as something separate from and outside the primary missions of public health and research.

The committee's final observation began: "We are very concerned that the CDC is on the way to losing credibility. The CDC must not see itself as "special." The internal controls and rules that the rest of the world works under also apply to CDC."