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 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. 

Vaccine mandates should only be imposed to protect other children. In this case, certainly for children under fifteen, they do not. 

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.
-----------------------------------------------------------------------------------------------------------------------

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

Lots of babies get measles in Africa and India, and it is a significant cause of death there.  A great deal of work has gone into developing measles vaccines that can be given to children at younger and younger ages, especially in Africa, for this reason. 

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 remained free of endemic 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:

... we carried out a case control study of vaccine failure in a recent measles epidemic. Compared to children vaccinated at ages 15 months or older, we found an increased risk of vaccine failure among those vaccinated at 12 to 14 months (relative risk = 19.2, 95% confidence interval = 4.6 to 80.1). In order to sort out the influence of age at vaccination from elapsed time since vaccination, we subjected the data to discrminant analysis. Age at vaccination subsumed all of the effect of duration of time since vaccination. Thus, we find no evidence of waning immunity over time.
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."