Sunday, January 10, 2016

Vaccines: You can't say No. But they're free

It is interesting... in the days when Americans paid for vaccines ourselves,  in cash, we were allowed to choose them for ourselves.  We did so, judiciously and appropriately.

No, I'm putting the wrong slant on this:  there was no "allowed" about it.  Back then, who ever imagined a future US government inserting itself into our health decisions, phones and every online click?

When I was a young adult, we thought only a Soviet gulag would treat its citizens like this.

We thought we had a Constitution that was the ultimate law of the United States.  We thought the job of the Supreme Court was to guarantee that US laws complied with our Constitution.

That was the world I knew.  My children know a different world entirely.  The Surveillance State, the corporatization of our public institutions, and endemic political corruption is all they have ever seen. 

They also grew up when health insurance and the Vaccines for Children program started covering the cost of American childrens' vaccinations.

Then came Obamacare, which was going to improve our health and save us money (ha!) by paying the costs for disease prevention.  "Prevention" under Obamacare turned into a few measly tests (which my ACA insurer is unable to identify) and a whole lot of vaccines--covered 100%! Several thousand dollars' worth of vaccines. The Affordable Care Act required all new health insurance policies to cover all vaccines recommended by CDC.  

And the 21st Century Cures Act, passed by the House in 2015 and pending in the Senate, will require CDC/ACIP (CDC's Advisory Committee on Immunization Practices) to rapidly consider for addition to the recommended list of vaccines every newly licensed vaccine. Many states automatically require every CDC-ACIP listed vaccine in order to attend school. This is one way the federal government manages to insert itself into our healthcare, an area legally excluded from federal control by the 10th Amendment to the Constitution:

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.
Last spring, in the blink of an eye, a sprinkling of measles grew a bumper crop of legislation in states throughout the US, informing parents the state would no longer educate their children, unless they let the state doctor them, as well.  

According to FOX News analyst (and retired New Jersey Superior Court Judge) Andrew Napolitano, if you don't give your children all state-mandated vaccines, the state can take your children from you, and the state--New Jersey--will educate them, doctor them and raise them for you:
New Jersey law... shows no deference to parents’ rights and permits exceptions to universal vaccinations only for medical reasons (where a physician certifies that the child will get sicker because of a vaccination) or religious objections. Short of those narrow reasons, in New Jersey, if you don’t vaccinate your children, you risk losing parental custody of them.

Requiring flu shots for preschoolers shot down in NYC/ NY Times

The NY Times had a comprehensive article about NYC's preschool flu shot mandate last January 2015. I blogged about the issue here; and now, in December, a judge has thrown out the mandate.

Children aged 6 months to 5 years and who attended any preschool program licensed by NY City were required to receive a flu shot.  The schools had to be the enforcers; if they failed to comply, they could be fined up to $2,000.  This rule was imposed in 2014 under outgoing Mayor Bloomberg, by decree of the unelected Board of Health.

Only two states, New Jersey and Connecticut, have imposed similar preschool flu mandates. Preschool flu shots were not required elsewhere in NY state.

If the shots worked well, choosing to get one might be a good idea.  But they work rather poorly. Estimates of efficacy range from 40% (CDC) to 1-3% (Cochrane Collaboration).

Because it is very difficult to assign side effects to vaccines, and because flu shot composition generally changes every year, it is impossible to know what the vaccine's side effects will be, until at least a year after the flu season is over.  This means that it is very difficult to determine the risk versus benefit of a flu shot before you get one.  Why subject our youngest citizens to vaccines for which both the benefit and risk are invariably unknown when they are used?

The judge ruled against the mandate on the basis that the NY legislature voted on other mandated vaccinations, and only the elected legislature, not NYC's health board, holds the authority to mandate vaccines.

UK govt trying to stop compensation it already granted for Narcolepsy cases linked to GSK's Pandemrix swine flu vaccine/ Guardian

Over 1,300 people who received the Pandemrix swine flu vaccine in 2009-10 developed narcolepsy.  Demographically,  adolescents were hardest hit. The vaccination caused profound neurologic disability and frequent personality changes in those affected.   

All governments that gave out swine flu vaccines were required (by manufacturers, the World Health Organization and pre-existing contracts that had been inked years earlier in the expectation they would be used for a deadly bird flu pandemic) to assume all liability for any injuries the vaccines might cause. Poland was the only country that publicly balked, and did not offer vaccine to its citizens.

After the swine flu pandemic ended, Finland noticed a spike in narcolepsy cases.  Since then, many studies have been done in about a dozen countries, and it has been established that Glaxo's Pandemrix swine flu vaccine caused a 10-16 fold increase in new narcolepsy cases. After years of debate, this part of the science is settled.

Although initially claiming the vaccine was not implicated in narcolepsy,  in 2013 the UK government admitted that the Pandemrix vaccine had in fact caused narcolepsy.  Some injured parties who were refused initially, were compensated with government funds.

However, in 2015 the UK government requested the right to appeal its earlier granting of compensation.  Most of those affected were adolescents, and the UK is now suggesting that they are less disabled than a working adult might have been. From the Guardian:

... Government lawyers are seeking to block compensation payments to people who developed the devastating sleep disorder, narcolepsy, as a result of a faulty swine flu vaccine. The Pandemrix vaccine made by GlaxoSmithKline (GSK) was given to 6 million people in Britain and millions more across Europe during the 2009-10 swine flu pandemic, but was withdrawn when doctors noticed a rise in narcolepsy cases among those who received the jab. 
Government lawyers are seeking to block compensation payments to people who developed the devastating sleep disorder, narcolepsy, as a result of a faulty swine flu vaccine.
In June 2015, a 12-year-old boy was awarded £120,000 by a court that ruled he had been left severely disabled by narcolepsy caused by Pandemrix. The win ended a three-year battle with the government that argued his illness was not serious enough to warrant compensation. 
The government has paid out to the boy’s family, but has nonetheless asked the court of appeal for permission to challenge the decision. A successful appeal would effectively deny compensation to 100 more families awaiting damages and could rule out any prospect of damages for other children who are injured by different vaccines in the future.
The government argues that vaccine damages should be decided on the immediate, rather than the future, impact of the vaccine-related injury. In this case, that would mean comparing the life of a 12-year-old boy with narcolepsy with a healthy boy the same age. Any effect on his future sex life, his ability to drive, his ability to work or go to university would be completely disregarded. 
“That is a radical interpretation of the law. It is very hard to show that you are disabled enough [to qualify for compensation] if the vast majority of your disability had to be ignored,” said the boy's attorney. “If their interpretation was accepted by the court of appeal, it would virtually abolish the prospects of anybody ever getting any vaccine injury compensation in the UK, because vaccines are mainly given to children and usually very young children.”
In the US, a new industry-friendly FDA Commissioner (Robert Califf, MD) is likely to be confirmed by the Senate this month. The 21st Century Cures Act, a bill that makes approval of drugs and devices easier, and promises to expedite the addition of new vaccines onto CDC-ACIPs list of recommended/required school vaccinations, was passed by 83% of the House and will soon be voted on by the Senate.  Other efforts are underway to weaken FDA regulation of drug safety and rush products to market.  Three hundred plus vaccines are in development. The head of FDA's vaccine center, Karen Midthun, MD, has announced her imminent retirement.

One might suspect that a cabal of industry and government insiders are working feverishly to deny any possibility of industry-provided compensation for injuries caused by drugs, medical devices and vaccines, before a slew of new, hurriedly approved products hits the market.  [In fact, since the 2011 Supreme Court Brucewitz decision, US vaccine manufacturers have had no liability for vaccine injuries in both federal and state courts. The goal of the UK government may be to reduce the definition of compensable injuries over there, before the wave of new vaccines appears.]

UPDATE: Feb 4, 2016 TechTimes
"A 10-year-old boy who developed narcolepsy from swine flu vaccine won £120,000 (nearly $175,000) in damages after a six-year legal bout. In 2010, Josh Hadfield received a Pandemrix vaccine and in three weeks developed narcolepsy, a condition that made him fall asleep almost every five minutes regardless of activity..."

Friday, January 8, 2016

FDA, CDC, NIH all have Foundations to Collect Industry Money to "Advance their Missions"

I blogged (here and here) about how the Inspector General System, set up by Congress to provide independent oversight of the 70 plus executive branch federal agencies, has been prevented from doing its job during the Obama administration.  In this post I discuss another way 3 federal health agencies (FDA, CDC, NIH) have been redirected from their public mission: private slush funds (Foundations) exist for each of the agencies.  In other words, there is a private back-channel for money to come in and go out from these agencies. To what purpose?
"... the Foundation provides a unique opportunity to bring all parties to the table (FDA, Patient Groups, Academia, other Government entities, and Industry) to work together in a transparent way to create exciting new regulatory science... " [And yet, the mission statement goes on to claim] "... it [the Foundation] does not participate in, nor offer advice to the FDA on regulatory matters or policy issues."
Fabulous.  "Exciting new regulatory science" in the current FDA context, means less careful drug/device approval. Over the past few years FDA has introduced 3 new pathways by which a drug, vaccine or medical device can be approved faster, and with less evidence than before. A new FDA Commissioner is expected to be confirmed soon by the Senate, despite his industry connections (he was paid by seven pharmaceutical companies in the year before his 2015 temporary FDA appointment).  He has called for more efficient, faster drug approvals.

Using a Foundation to transfer funds is certainly not the only means by which industry has its way with the executive branch agencies, but it is instructive nonetheless to see who donates and how much.

For the FDA Foundation, six pharmaceutical companies paid $350,000 each in 2013, two entities paid $400,000 each and one $500,000.  The following were named (page 17) while others were unnamed in the tax return.

 Eli Lilly $ 400,000.00
 AstraZeneca 350,000.00
 GlaxoSmithKline 350,000.00
 Johnson & Johnson 350,000.00
 Merck 350,000.00
 Novartis 350,000.00
 Pfizer 350,000.00

In its 2014 tax filing, 5 unnamed entities gave the Foundation $500,000 each.
Do these amounts look like voluntary donations?  Why are the amounts so similar?  They look more like some sort of "tax" or "tithe" the companies were told to pay.  Is the Foundation the FDA's "enforcer"?

One liability in the 2014 tax return was for $255,000--a "grant refund payable."  Did FDA fail to carry out the conditions of the grant?  What conditions might those have been?

And check this out:  even though the FDA Foundation (Reagan-Udall Foundation for the FDA) is a 501C3, the FDA pays its operating expenses:
"Core Operations will be run on a day-to-day basis by the Executive Director and will be funded through:
  1. FDA funds specifically prescribed under the statute to be appropriated to the FDA and then transferred to the Foundation ($500k-$1.25m)"
While the FDA Foundation collects over $4 million a year, this turned out to be peanuts.  The CDC Foundation received over $42 million in "donations" in 2013.  The NIH Foundation received almost $73 million in 2014.  What did these funds buy?

NIH (like CDC) has an industry slush fund, with NFL its largest donor, allowing NFL veto power over concussion research/ ESPN

The story about the NIH funding for concussion research is confusing, because neither NIH nor the NFL will say exactly what transpired.  But the NFL gave (or merely promised) $30 million to the NIH Foundation in 2012.  But it seems there were strings attached.  NFL was unhappy with a researcher given the NIH grant, and appears to have rescinded the money--refusing to pay for the study that NIH promised to fund, apparently using NFL money.  Now NIH says it will fund the study itself. Under what set of conditions does the NIH Foundation take industry money, one might ask?  

We've learned that, like CDC, NIH has a Foundation (the Foundation for NIH, or FNIH) which seems to be a conduit through which it can receive industry funds and do industry bidding, while the taxpayer funds NIH to the tune of $30 billion/year.  The 30 million dollar NFL grant to FNIH is said to be the largest the Foundation has received.

According to ESPN
"The NFL, which spent years criticizing researchers who warned about the dangers of football-related head trauma, has backed out of one of the most ambitious studies yet on the relationship between football and brain disease, sources familiar with the project told Outside the Lines...
From 2003 to 2009, the NFL published its own research denying that football players get brain damage; much of that research was later discredited. But since then, the NFL has poured tens of millions of dollars into concussion research, allowing the league to maintain a powerful role on an issue that directly threatens its future...
Dr. Walter Koroshetz, director of the NIH's National Institute for Neurological Disorders and Stroke, told Outside the Lines this week that he had asked the FNIH over a period of several months if the NFL would be providing funding for the study but never received a definitive response. He said he attempted to expand the study over the summer to include other researchers -- a proposal that might have satisfied the league. But the NIH ultimately decided to fund the study on its own... 
The NFL's $30 million grant -- its largest single donation -- is administered by the Foundation for the NIH (FNIH), a nonprofit organization that solicits donations for NIH research... 
From the Foundation for NIH: 
"The Foundation for the National Institutes of Health procures funding and manages alliances with public and private institutions in support of the mission of the National Institutes of Health (NIH), the premier medical research agency...
The FNIH was established by Congress in 1990 as a not-for-profit 501(c)(3) charitable organization. The Foundation began its work in 1996 to facilitate groundbreaking research at the NIH and worldwide. As an independent organization, it raises private funds and creates public private partnerships to support the mission of the NIH—making important discoveries that improve health and save lives."