Every phone call is noted and emails maintained by the US government. What don't they know? Why is there a concerted effort to shoot the messenger?

"The right of the people to be secure in their persons, houses, papers, and effects, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized."

That is the Fourth Amendment to the Constitution, part of the Bill of Rights:  a list of rights guaranteed to all Americans by the founders of our great nation, through our Constitution.  It could not be clearer:  leave our papers and effects alone unless you can show probable cause to go after them-- and then provide a sworn oath and a description of what is to be seized.  I can give you the description of what the government is seizing:  all communications that travel electronically.  Everyone's.  No probable cause, no oath, no affirmation, no description of specific items.  Snowden (and others) claim the government can wiretap--listen in on--the contents of all phone calls, not just look at the numbers you called.  Electronic storage is cheap.  Did you get a look at the data center being built in Utah to handle the mountains of info being collected by NSA on us all?

According to Utah TV station KSL:

... The secrecy surrounding the project has led to speculation it will become a vast storehouse of personal communications of average Americans.

The facility is 1 million square feet of space, with a price tag well above $1 billion; and it will have an appetite for electricity that would embarrass Godzilla. Computers and cooling systems at the NSA's Utah Data Center will reportedly consume $40 million worth of power each year. The power company won't say if that widely reported estimate is valid...

Our Constitution and our guaranteed freedoms have been shredded by our federal elected leaders, although the President and every member of Congress has sworn to uphold them.  What a terrible joke it is.

Adding insult to injury, the same elected leaders are now stirring up a witches brew to destroy Edward Snowden, who had the temerity to inform us of the crime our government is committing against us.  How dare he, they seem to be saying.



He calls our attention to a serious transgression, committed against us and against our Constitution, and the Boehners and Feinsteins of the world call him a traitor.  Can someone give them a mirror?

In a victory for sanity, a Reuters poll this week shows that more Americans see Snowden as a patriot than a traitor.

The Daily Beast provides the flip side of the Boehner/Feinstein/WaPo coin.  Though many in the mainstream media have echoed Feinstein and Boehner's claims that Snowden is a criminal, the Philadelphia Inquirer editorialized nicely with a very clear discussion of the issues, the responsibilities of Congress, privacy and secrecy.

Danny Schecter at Common Dreams puts the story in perspective vis a vis alleged Chinese cyber hacking and Obama-Xi Jinping's summit at which such matters were being discussed.  Now it turns out we were doing the same cyber hacking that we accused China of doing.

With Snowden now seemingly on the run - in Hong Kong or elsewhere - the US press has piled on for a rabbit hunt, featuring article after article quoting officials on why he is a traitor. There is a snotty elitism to the putdowns citing his unimpressive educational background.

Snowden quickly became the media focus - if only because, once again, an individual's transgression is sexier to cover than an analysis of the institutional leviathan behind the chase...

We also learned most of the big internet brands played along, without disclosing anything, silenced by secrecy or being complicit due to a simple desire to stay on Washington's good side. Only Google seems to be fighting back, but after the fact. So much for all the sanctimonious privacy codes they all promote.

Clearly that old military-industrial complex, first condemned by President Eisenhower in 1960, now has expanded into a far larger behemoth, incorporating digital media, co-opting the internet, integrating the intelligence community, winning over Congress and the press, and giving the president even more power to launch cyber-wars and to target whomever he wants.

Colleen Rowley, the former FBI agent who made the cover of TIME Magazine for her 9/11 whistle-blowing revealed that this was another Obama-sanctioned initiative with deep roots in Cheney-Bush paranoia.

"The recent disclosures… should make us realise that John Poindexter's plan for 'Total Information Awareness' never died: It merely went underground and changed its name...

Alongside the escalation of surveillance and spying, the administration built its own paramilitary capacity and action army - reportedly run from the White House. Writer Fred Branfman who exposed Vietnam-era secret bombing, links all of this to: 

• A fleet of 700 drones, operating from a growing number of secret bases. worldwide

• The top-secret Joint Special Operations Command (JSOC) consisting of thousands of troops operating in dozens of nations

• The first unit of American assassins in US history, who have illegally murdered many… and, according to Afghan President Karzai, helped strengthen the Taliban and destabilise his government

More whistle-blowers and journalists have reportedly been prosecuted under Obama than during the Bush-Cheney years, and, Branfman says, US executive branch agencies have "increased paramilitary training and equipment, and created secret police spying operations in thousands of states and cities around the nation".

He also cites earlier reporting in the Washington Post by Priest and Arkin, who revealed that the executive branch had created "a jaw-dropping 1,074 federal government organisations, and nearly two thousand private companies involved with programs related to counterterrorism, homeland security, and intelligence, in at least 17,000 locations across the United States - all top secret".

In short, this incident is an outgrowth of an industry with high-paying jobs while the nation's economic growth remains static. The only stimulus is for the spooks.

This scandal should be a perfect "news peg" to help us connect the dots between what is being exposed today and how it relates to what we should have known, if we had been paying attention to earlier piecemeal disclosures...

Japan Health Ministry Withdraws its Recommendation for HPV Vaccines for Women/ Japan Times

Mika Matsufuji, second from right, and other members of the “Zenkoku Shikyukeigan Vaccine Higaisha Renrakukai” hold a news conference to explain possible side effects of a vaccination against cervical cancer in Tokyo on March 25. (Asahi Shimbun file photo)

The Japan Times refers to halting both Gardasil and Cervarix vaccines. In the US, attention has focused on neurological abnormalities.  In Japan, these have occurred, but the expert panel focused on 38 recipients who developed chronic pain syndromes. I have seen a large number of chronic pain disorders (usually associated with fatigue, cognitive and sometimes personality changes) occur following anthrax vaccinations, so it seems logical that other vaccines may cause similar disorders.  Note that Gardasil was approved by FDA under a "fast-track" designation, without definitive evidence of either safety or efficacy at the time of licensure, and many studies are still in process that were required by FDA to issue the license.

Note also that two years after giving its approval, FDA required Merck to add warnings to the Gardasil label for muscle pains, joint pains and fatigue.   

FDA's MO is to warn in the label and continue to allow product sales without restriction, and continue to allow this and other vaccines to be promoted, and in some cases mandated, by federal and state authorities..           

The health ministry has issued a nationwide notice that cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16 because several adverse reactions to the medicines have been reported.

“It is necessary to gather information immediately to accurately grasp how often (the side effects) are occurring,” said Mariko Momoi, who chairs the panel at the Health, Labor and Welfare Ministry that decided to suspend the recommendation. Momoi is vice president of the International University of Health and Welfare.

Cervical cancer vaccines are a recent addition to the regular vaccination list and were added after a revision to the Preventive Vaccination Law took effect in April...

Mika Matsufuji, 46, who represents an association of cervical cancer vaccination victims’ parents, said the health panel’s decision was a “big step forward.” Her daughter, who was vaccinated with Cervarix in 2011, lost the ability to walk and is now in a wheelchair, she said.

The group is calling for the vaccinations to be halted.

The panel said there was a strong possibility that severe prolonged pain was caused by some of the vaccinations. It concluded that active recommendation of cervical cancer vaccinations should thus be halted until a more complete picture of their side effects can be attained.

The ministry said this is the second time it has suspended a recommendation related to the regular vaccine program since problems cropped up with the Japanese encephalitis vaccine in 2005...

According to the Japanese newspaper Asahi Shimbun,

The health ministry decided June 14 to withdraw its recommendation for a vaccination to protect girls against cervical cancer after hundreds complained about possible side effects, including long-term pain and numbness.

The Ministry of Health, Labor and Welfare is not suspending the use of the vaccination, but it has instructed local governments not to promote the use of the medicine while studies are conducted on the matter...

The government’s subsidy program for vaccination against cervical cancer started in 2010. The vaccination became regularly used in April this year under revisions to the Preventive Vaccination Law.

 Those subject to the vaccination range from six-graders of elementary schools to first-year students of senior high schools.

So far, an estimated 3.28 million people have received the vaccination. However, 1,968 cases of possible side effects, including body pain, have been reported.

GMO Heat Rises Against Monsanto / Wall St. Cheat Sheet

Monsanto (NYSE:MON), the Missouri-based seed company, has stopped lobbying for GMO crops in Europe. The company is backing off because it has accepted that there is low demand for genetically modified plants in Europe. A Monsanto Germany spokeswoman, Ursula Lüttmer-Ouazane said ”We’ve come to the conclusion that this has no broad acceptance at the moment.” She also noted that it was “counterproductive to fight against windmills.”

Monsanto has faced a lot of backlash in Europe.  Eight governments in the EU have already banned the company’s MON810 maize as well as other generically modified crops. This environmental protection provision is known as the “Safeguard Clause.”

For instance, the company has faced fierce protests in Germany. These protests prompted the government to enact provisions in 2009 because of concerns that allowing GMO crops would lead to environmental degradation. Other EU members including Greece, France, Bulgaria, Hungary, Austria, Luxembourg, and Poland have also enforced a ban on these crops.

A spokesman for Monsanto told the press that they are only going to sell their genetically modified seeds where they have broad support. This means only a few countries in Europe, such as Spain and Portugal. The company is looking in increasing its market share in various parts of the world, such as the traditional corn market in Ukraine. It is looking at Eastern Europe and South America as growth areas, especially after the reception it received in Western Europe.

South America has welcomed GMO crops unlike Europe, but there are still hurdles that Monsanto has to face there as well. Brazil is waiting for approval from China to use Monsanto’s seeds because China is a huge buyer of Brazil’s soybeans.

Vaccinating Maine Children: Doing it Better, Doing it Honestly / Meryl Nass

LD 754, a bill to require that a list of vaccine ingredients be provided to parents when their children are vaccinated, has stirred up a hornet's nest in Augusta.  The gist of what was written in a Bangor Daily News opinion piece and in a paper circulated by Representatives Pringle and Volk is:

•           If parents were given a list of vaccine ingredients, a large number might choose not to vaccinate their children. 

•           Parents might feel the medical provider did not support vaccinations.  

•           Parents might take this as a veiled warning, rather than neutral information.

•           The end result could be loss of herd immunity, leading diseases to circulate throughout the population in increasing numbers.

The assumption is that if people knew more about how vaccines are made and what they contained, more parents would not want to vaccinate their children.  

The implication is that the public must be protected and protection requires that parents remain ignorant of some possibly unpleasant facts, unless they make an independent effort to find those facts for themselves.

There are two elephants in the room that underlie the strong feelings engendered by the vaccine issue. 

*  Elephant #1:  People who vaccinate their children do not want to be put at risk by those who choose not to vaccinate, or who delay vaccinations.  According to CDC, only one percent of American children are unvaccinated, and ten percent receive delayed vaccinations or are partially unvaccinated.

Do these children put others at risk?  Ninety percent of US children are fully up to date with their vaccines. This should be more than sufficient to maintain herd immunity, if the vaccines they receive convey strong, persisting immunity.  But other factors should be considered:

1. Some vaccine antigens only induce weak, short-term immunity
2. A growing number of Americans do not develop immunity from the vaccines they receive or cannot safely receive them, due to being too young, receiving immune suppressing drugs, including corticosteroids, for cancer or autoimmune diseases or because they have an immunodeficiency disorder.

Partially or wholly unvaccinated children are wrongly being blamed for disease outbreaks. The US has had increasing numbers of cases of mumps, measles and whooping cough in recent years, but not for the reasons you might think.

According to CDC, over 75% of recent US cases of mumps and whooping cough have occurred in fully vaccinated individuals. Because these vaccines are relatively weak, vaccine-induced immunity, unlike the immunity derived from an infection, wanes rapidly. One recent study showed that only 3 years after receiving the recommended 2 lifetime doses of MMR vaccine, only 93.8% of children had measurable mumps antibody.

Even after receiving 5 doses of the childhood vaccine for whooping cough, immunity is often gone by the next recommended dose 6 years later.  Adding more doses does not fix this problem.

According to CDC, 90% of the 222 measles cases in the US in 2011 were linked to measles imported from overseas, and the source was undetermined in 10% of cases.

Even if the US were to achieve 100% vaccination rates, this would not prevent vaccine-induced immunity from wearing off, nor would it prevent disease importations from overseas.

Although the material you were given implies that the vaccinated are at risk from the unvaccinated, this is not the main cause of “vaccine-preventable” disease outbreaks in the US.

*  Elephant #2 is very threatening and confusing to parents, as well as to experts:  Do vaccines cause autism?  It is simpler to believe that a British doctor, Andrew Wakefield, who posited this connection in 1998 in the Lancet and then had his medical license revoked, was dead wrong.  But according to recent figures from CDC, a growing number of American children--2%--now carry an autism diagnosis.  Some of them (30%) developed normally, then regressed into autism at about 18-24 months, sometimes days after a vaccination.  There is still no explanation for this epidemic.  Its cost to society dwarfs those of childhood infectious diseases.

Many parents are understandably scared to vaccinate and scared not to vaccinate. No one has enough information to know what is best to do.  But the fact remains that some vaccines cause permanent neurologic disorders in some children.  The DHHS Vaccine Injury Table lists many disorders that the federal government accepts are the result of vaccine injuries.

It is established that vaccines may cause neurologic disorders and death.  What is not clear is how big the risk is for each child.  Without this information it is impossible to calculate the risks and benefits for vaccines.

Some families pay a terrible price for devastating vaccine injuries.  If serious vaccine injuries are a one-in-a-million-child occurrence, there is probably large benefit from vaccination.  But if they are a common occurrence, it might be safer to omit certain vaccinations. Yet no definitive research has clarified the frequency of vaccine injuries.  

Vaccine Safety and the Duty to Warn

Congress, the FDA and Supreme Court acknowledge that as a class, vaccines are “unavoidably unsafe.”  As noted in the DHHS Vaccine Injury Table, vaccines in some cases cause paralysis, encephalopathy, encephalitis, brain damage, anaphylaxis, chronic arthritis, polio, measles, and other serious medical problems, including death.

The dissenting Supreme Court opinion in the 2011 Brusewitz v Wyeth case, which removed all potential liability from vaccine manufacturers, points out the importance of proper directions and warnings for vaccines. The absence of adequate warning to consumers is considered a labeling defect.  “Congress created a presumption that, for purposes of §22(b)(1), “a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with” federal labeling requirements. 42 U. S. C. §300aa–22(b)(2).”  

Finding vaccines unavoidably unsafe, Congress specified that manufacturers had a duty to warn consumers. Now that many people are being vaccinated in supermarkets and drug stores, precluding any discussion with a medical provider, the duty to warn is even greater than when first required by Congress. Parents receive vaccine information sheets when their children are vaccinated, but often not until after the vaccine is administered.

The Future of US Vaccines

Clearly, what are needed are better vaccines:  those that will offer reliable, long-lasting immunity and reduce serious side effects to the lowest possible level. However, neither goal will be achieved under the current system, as there is no incentive for vaccine manufacturers to improve their products while the vaccines are mandated and their manufacturers protected from any liability by law.

Achieving this will require research into the causes and rates of vaccine injury, untainted by vested interests.

Furthermore, there is no incentive to create the very best vaccines for diseases of the future. To the contrary, some future vaccines are likely to be more dangerous than currently licensed vaccines. 

Although a swine flu vaccine used in Europe (Pandemrix) caused over 800 cases of severe narcolepsy in children, the vaccine adjuvant that most experts suspect was the culprit, ASO3, may soon be included in a US vaccine.  According to Reuters:

"The adjuvant in the Pandemrix vaccine is very potent and we think it may have played a role," says Markku Partinen, a neurologist at the Helsinki Sleep Clinic in Finland who has spent the past few years investigating what might be behind the link between the vaccine and narcolepsy.

If it is the reason for the spike in the disease, Partinen and other researchers think it may be because the adjuvant's strength boosted not just a good immune response but possibly an adverse one too.

Partinen was one of the first scientists to pick up a signal that something might be going awry in children in Finland vaccinated with Pandemrix in a nationwide immunization campaign against the H1N1 flu.

Since then studies in Sweden, Finland, Ireland and now Britain have found the risk of developing narcolepsy is between seven and 13 times higher in children who were immunized with Pandemrix than in those who were not.

Among the 800 cases of Pandemrix-related narcolepsy reported so far across Europe, many are children who say the life-long and incurable disease has all but wrecked normal life.”

FDA is now considering an ASO3-adjuvanted avian flu vaccine for licensure in the US:

Scientists believe AS03 may be the culprit in the narcolepsy cases though they have yet to decipher the precise nature of the association.

That uncertainty poses a challenge for the U.S. Food and Drug Administration, which is considering an AS03-containing vaccine for use in the event of an H5N1 bird flu epidemic. Like Pandemrix, which has not been approved in the United States, it is made by GSK and is almost identical in structure.

A 14-member panel of advisors to the FDA voted unanimously in November to recommend the vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk…’’

Opportunities

What should the Maine Legislature do?  Consider the following:

Ø    Manufacturers face zero risk of liability for vaccine injuries.  Many vaccinations are now given in the absence of medical providers, eliminating possible discussion of risks and benefits.  How can Maine best support the duty to warn consumers of potential vaccine risks and benefits? This duty falls on the manufacturer, but should also fall on the state when it mandates childhood vaccinations.  

Ø    Should the vaccine information statement be given to parents before their children are vaccinated?  Should parents sign a form that says they have read the statement before their children are vaccinated?  Should parents be given a list of ingredients in the vaccine?  Should parents be informed when ASO3 or a similar novel adjuvant is included in a vaccine?

Ø    Can Maine establish a data collection for regressive autism cases, to assess the temporal relationship between vaccinations and neurologic changes?

Ø    Maine is one of a small number of states that initiated school-based flu vaccine clinics in 2009.  Their value is questionable and cost significant.  The federal CDC grant for these clinics covered the last two flu seasons and has expired. Should the state continue to support them?  Perhaps the money saved could be spent on a study of vaccinations and their relationship to neurologic disorders in Maine.

Ø    Should the Maine legislature suggest to Congress that it revisit the issue of vaccine liability, in order to create incentives for better and safer future vaccines?

Genetically Modified Organisms: Want More Information?

Dr. Joe Mercola published an excellent short piece on GMOs this week here.

EarthOpenSource published a 123 page report on the science of GMOs, here.

GMO's unacceptable elsewhere, good enough for Americans: Japan Suspends Some Imports of U.S. Wheat

Most US corn, sugar, canola oil and soy produced and sold in the US is genetically modified. That includes most food for human as well as animal consumption.  Monsanto has had patents on GMO wheat since the 1990s.  

However, wheat is the US' largest export crop. Rather than being fed to livestock or unwary Americans, half is shipped overseas. Because importing countries (including Europe, China and Japan) don't want GMO wheat (it still isn't approved for consumption in a single country), it is illegal in the US to grow it, outside "highly controlled" test plots.  

From the NY Times came this clumsy statement, which implies that processed foods made from GMOs are not consumed by people.  Of course they are:  an estimated 70% of processed food in the US contains GMOs.  Widespread consumer resistance to GMOs in the US has failed to impact Monsanto's influence on lawmakers.  But consumer resistance outside the US means that US farmers can't sell Monsanto's GMOs overseas, and wheat exports are critical to the US economy.  This has spared US consumers from GMO wheat, so far.

While most American soybeans and corn are genetically modified, those crops are largely consumed by animals or made into processed foods. Wheat is consumed directly by people and there has been more consumer resistance. No genetically engineered wheat has been approved in any country. Indeed, one reason Monsanto dropped its development of genetically modified wheat in 2004 was concern from American farmers that it would endanger wheat exports.  

Monsanto has now resumed research into genetically modified wheat but says it will be at least a decade before any such crop reaches the market...

In 2006, after traces of an unapproved genetically engineered rice were found in the American harvest, rice prices dropped, at least temporarily, and exports slowed.Bayer CropScience, the company that developed and field-tested the rice, agreed to pay $750 million to settle claims with about 11,000 American farmers.

However, some (how much? enough to cause the price to plummet) Monsanto-bred, US-grown wheat found its way into farmers' fields.  And experts suggest it has probably been there for awhile.

US consumer product regulation is arguably the weakest among developed countries at this point.  Fortunately for the Japanese and most Europeans, their regulators are still on the job.  And in record time, Japan and the European Union told us we could put this American wheat where the sun don't shine.

American legislators and regulators have passed legislation banning the labeling of GMO products, because they know that Americans, if warned, will shun them too. From the WP:

... The United States already relies heavily on genetically modified crops. Genetically engineered corn, cotton and soybeans have gone from 5 to 17 percent of the U.S. market in 1997 to between two-thirds and more than 90 percent in 2012. By some estimates, more than 70 percent of processed foods sold in the United States contain ingredients and oils from genetically engineered crops. 

... Monsanto and other companies in the industry have been pressing members of Congress to vote against measures that would require disclosure for food made with genetically modified or engineered crops. Friends of the Earth, an environmental group, says that 64 countries have similar rules and that, this year, 37 bills have been introduced in 21 states proposing that genetically engineered foods be labeled in stores. 

Monsanto is also urging lawmakers to vote for a rider in the Senate continuing resolution that would strip federal courts of the power to provide injunctive relief to environmental and food activists seeking to stop the spread of such crops. 

Genetically modified crops have a history of provoking bans by trading partners. In 2006, the Agriculture Department announced that trace amounts of a regulated variety of genetically engineered rice had been commingled with supplies of conventional rice. That led several U.S. trading partners to refuse U.S. rice exports, causing losses for U.S. farmers and exporters.

And from Reuters:

... The discovery instantly roiled export markets, with Japan canceling a major shipment of wheat, a quick reminder of what is at stake - an $8 billion U.S. wheat export business. Many fear the wheat most likely has been mixed in with conventional wheat for some time, but there are no valid commercial tests to verify whether wheat contains the biotech Roundup Ready gene.  

"A lot of people are on high alert now," said Mike Flowers, a cereal specialist at Oregon State University. "We can't really say if it is or isn't in other fields. We don't know..." 

From RT:

Other major Asian importers like Korea, China and the Philippines said they were closely monitoring the situation, while the European Union is set to test any incoming shipments, saying it will block any containing GM wheat.  

Following the announcement, wheat for July delivery fell 8.25 cents to $6.945 a bushel on the Chicago Board of Trade.   

The wheat, created by Monsanto Co., appeared on an 80-acre farm in Oregon in April. On Wednesday, the US Department of Agriculture (USDA) said it had conducted a genetic test on the wheat and found that it was an experimental type created by the US agribusiness giant which had never been approved for sale.  

...The USDA has never approved any GMO strain of wheat to be grown in the US, but Monsanto field tested a genetically engineered variety from 1998 through 2005. It was never put into use however, due to global opposition to genetically engineered cereal grains. Wheat remains an exception however, as more than 60 genetically modified crops have been approved for US food and feed supplies.  

The top three GMO crops grown in the US are soy, corn and cotton, according to the USDA. Some Eighty-eight perc ent of corn and 93 pe rcent of soybeans grown in the US are genetically modified.   

Although the United States produces only 10 percent of world wheat it is consistently the world's biggest wheat exporter. With world trade in wheat greater than for all other crops combined, Wednesday’s findings could dent US export prospects at a time when the USDA is expecting record global production, boosted by a 48 percent hike in Russian output and a 40 percent gain from Ukraine.   

However, the USDA says US exports will likely fall 9.8 percent to 25.2 million tons in the year that starts on June 1, Bloomberg reports.     

“This is not something we need to see when exports are suffering anyway,” Darrell Holaday, the president of Advanced Market Concepts in Wamego, Kansas, told the New York based agency in a telephone interview.

She's at it again! (Margaret Chen blowing smoke about the next pandemic) / CBS

Beginning in April, 2009 we heard from the talking health heads, especially WHO Director General Margaret Chen's, about the world-threatening pandemic swine flu.  Her pronouncements sold a lot of Tamiflu and vaccines.  (Probably at least 5-10 Billion dollars' worth worldwide; anyway, the price tag was so high we never got a straight answer from the USG about how much it spent.)  Most of it (both the money and the majority of the vaccine produced) went down the toilet.

No, sorry, I'm wrong:  the Pandemrix vaccines and all US swine flu vaccines shipped in multidose vials contained mercury and therefore had to be treated as hazardous waste.  This required spending significant additional money to get rid of them.  It would have been so much simpler to just put all those vaccine doses into arms.

Recall that it was WHO/ Chen's declaration of a pandemic that triggered a "BUY" for the vaccines, based on preexisting contracts between vaccine manufacturers and national governments.

Well, now it may be time to get ready for the next pandemic pie-in-the-sky roller-coaster:  We scare you, we charge you, we inject you.  Do you feel safer now?

From CBS:

GENEVA (CBS Atlanta/AP) — The World Health Organization warns that the deadly SARS-like virus first seen in the Middle East is a global threat.

Dr. Margaret Chan, WHO’s director-general, said in a speech in Geneva Monday that the new respiratory coronavirus MERS “is a threat to the entire world.”

“Looking at the overall global situation, my greatest concern right now is the novel coronavirus. We understand too little about this virus when viewed against the magnitude of its potential threat. Any new disease that is emerging faster than our understanding is never under control,” Chan said during the 66th World Health Assembly.

Yet 8 months since it was discovered, only 44 people are known to have been affected, and only 24 have died.  Does that sound like Armageddon--no, wrong again--Pharmageddon to you? 

Hysterical Takedown of Bioethics and Bioethicists/ Richard John Neuhaus

Neuhaus got in so many great jabs in this piece I was nearly rolling on the floor.  Though published in 2002, it is as timely today, and the players are the same, too!  Enjoy.

The Best BioethicistsThat Money Can Buy

          Richard John Neuhaus

"A bioethicist is to ethics what a whore is to sex.” That judgment by a friend who was once viewed as a pioneer of bioethics may seem somewhat harsh, but it is not entirely off the mark. This really happened: Some years ago I was on a panel at the big annual economic conference in Davos, Switzerland. Also on the panel was Nobel Laureate James Watson, then head of the Human Genome Project. I and a few others—well, I think it was one other—were pressing moral questions about the technological manipulation of human nature. Impatient with that line of inquiry, Dr. Watson—who seems not only to subscribe to but to devoutly celebrate what Jacques Ellul called the Technological Imperative—explained that nobody should worry about the morality of what they were doing since the project had allocated millions of additional dollars “to get the best ethicists that money can buy.”

A number of publications have in recent months raised sharp questions about the biotech industry and its connections with the sub–industry of bioethics. For the most part, bioethicists are in the business of issuing permission slips for whatever the technicians want to do. After all, they are in their pay. Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics and perhaps the most quoted bioethicist in the business, thinks that criticism is unfair. He says that possible conflicts of interest can be “managed.” He funnels money from companies such as Pfizer, DuPont, and Celera into his center, and says he is amazed by colleagues who suggest that bioethicists should do pro bono work for wealthy corporations. Why do it free when they’ll pay good money for it? U.S. News & World Report says that the biomedical industry is pouring millions into bioethics centers, and rewarding academic bioethicists with stock options worth many thousands of dollars. The same ethicists are quoted daily in the media, testify in Congress, and generally assure the public that there’s nothing to worry about so long as scientific innovations are accompanied by appropriate expressions of concern by professional handwringers. “It’s an odd development,” says U.S. News, “for a profession that has no formal education or licensing requirements.”

Wesley J. Smith is author of Culture of Death: The Assault on Medical Ethics in America. He writes, “The bioethicists have set themselves up, almost like Napoleon crowning himself emperor, as the arbiters of what is moral and ethical in health care.” Daniel Callahan is cofounder of the Hastings Center, an institution that laid the groundwork for bioethics back in the sixties. “This is a semi–scandalous situation for my field,” he says. “These companies are smart enough to know that there are a variety of views on these subjects, and with a little bit of asking or shopping around you can find a group that will be congenial to what you are doing.” Carl Elliott, who succeeded Arthur Caplan at the University of Minnesota’s Center for Bioethics, says, “Personally, it seems too much like bribery. If it’s not bribery, it becomes the perception of bribery.” Caplan, on the other hand, says that apparent conflicts of interest are comparable to the problems of magazines that accept paid advertising. The main problem with corporate money in bioethics, he says, is that there’s not enough of it. Eli Lilly stopped funding the Hastings Center when its publication criticized Prozac, a Lilly product.

“There’s a risk that this kind of funding could reduce the critical edge of the field,” says Dartmouth’s Ronald Green, who chairs the ethics board at Advanced Cell Technology (ACT). ACT knows all about the cutting edge, having been at the center of recent “breakthroughs” in human cloning. As does Professor Green, who, in his extensive writing, has “redefined” death, birth, life, and the meaning of the universe, among other things. Like Prof. Caplan, he recognizes that there is a risk, but is sure it can be managed. He has, by his lights, managed very successfully. Minnesota’s Carl Elliott says the big danger is not that bioethicists get rich from companies but that they are, whether they know it or not, used. “Bioethics boards look like watchdogs,” he says, “but they are used like show dogs.”

Nigel Cameron, a bioethicist working with Charles Colson’s Wilberforce Forum, notes that bioethics is not what one would ordinarily call a discipline or profession. “Most bioethicists don’t train in bioethics. They move sideways from other disciplines—law, theology, medicine, philosophy.” The field is “perfectly designed to be the midwife for the birth of a whole posthuman future.” He notes that ethics as ordinarily understood—classical ethics, if you will—works from rules or principles to guide moral judgment. “Bioethics doesn’t like being locked into any kind of framework that would involve predictability. From a Christian or traditional perspective, it isn’t ethics at all, but uses items from the ethics toolbox so it can do what it wants in any situation.” William Saletan, a writer for the online magazine Slate, sums it up: “The slickest way to make yourself look ethical is to narrow the definition of ethics so that it won’t interfere with what you want to do. But that won’t make you ethical. It’ll just make you an ethicist.”

So what is to be done? Certainly biomedicine and biotechnology call for the most careful moral scrutiny. But whose scrutiny is to be trusted? Nobody comes to these questions, or any questions of importance, with a value–free or value–neutral perspective. But some are free of clear conflicts of interest, unlike the ethical pipers who sing the tunes of the companies that pay them. Their promiscuously issued permission slips would license almost anything, and the slips are typically accompanied by promissory notes that this innovation or that will lead to a cure for everything from Alzheimer’s and cancer to the heartbreak of psoriasis. Such promises are powerfully appealing, including, as proposed at a recent University of Pennsylvania conference, the promise of immortality.

Never mind that extravagant promissory notes have been issued for decades and are almost never redeemed. Those at the cutting edge assure us that the decisive breakthrough is just on the other side of the line that it was previously forbidden to cross. The biotech industry is driven by scientific curiosity, no doubt, but most importantly by the prospect of wealth beyond the dreams of avarice. How many people of great means would be willing to pay how much for an extra ten, twenty, maybe fifty years of life? How much for the promise of immortality? And what moral lines would they, and those who make such promises, not be prepared to cross?

In real ethics, there are some things that must never be done. Bioethics is “procedural.” Where it can, it leaps ahead, and where it cannot, it inches ahead, enticed onward by the question, Why not? If it can be done it should be done, or in any event it will be done, and, if it will be done, why not by us rather than by the competition? This is ethical reasoning of a very low order. There is no sure way of protecting society against it. But we might begin by asking the experts who advocate the crossing of the next moral line, What’s in it for you? 

More data link increase in narcolepsy cases to Pandemrix vaccine in ADULTS aged 20-64/ AFP

From AFP:

HELSINKI — Finnish researchers unveiled new data Thursday to link the Pandemrix flu vaccine to a higher risk of the sleeping disorder narcolepsy in adults. 

Other studies had already shown a link between the drug used in the 2009-10 "swine flu" outbreak and a higher incidence of narcolepsy in vaccinated children, teens and people under 30. 

The new research, conducted by Finland's National Institute for Health and Welfare, found that Pandemrix-vaccinated adults between the ages of 20 and 64 had a three-to-five times higher risk of contracting the disease than non-vaccinated people...

The SUPPORT Trial: Good intentions in medical research are not enough--especially when lives are at stake--you also need to avoid hurting patients and to use a design that will yield useful info

Medical research is necessary:  there are innumerable unanswered questions about how to best treat patients.  When lives are at stake, answering the questions is very important.  Modern medicine was built on the back of medical research, built on clinical research that must rely on the goodwill of human volunteers.

Volunteers participate as research subjects under the expectation that they will not be placed at greater risk of harm by volunteering than they would be otherwise.  Their willingness to volunteer comes from the expectation that the research is being conducted intelligently, and ethically, in order to move medical care forward, and not for other reasons.

Furthermore, federal regulations regarding human research require that volunteers be fully informed about the risks and benefits of the research in which they will participate.

When the research involves children, the regulations are even stricter, since children cannot give informed consent and are considered a vulnerable group.

Now to the SUPPORT trial.  Tiny, premature newborn babies were the subjects of experiments the were meant to answer questions about the ideal amount of oxygen to be given, the use of surfactant in premature lungs, and how oxygen should be administered.  Good questions.

But the trial design and the way the trial was conducted failed to meet current legal and ethical standards.  And therefore it has been investigated by the Office for Human Research Protection in the office of the HHS Secretary.  (OHRP moved out of NIH in 2000; I thought it was still under NIH when I first wrote this.) In response, the medical research and bioethics communities are beginning to link arms to defend the sanctity of this medical research, and scream loudly about those who dare to question the research and researchers.

This makes sense when you realize that Bioethics as an academic 'discipline' has become (mostly) a group of apologists for whoever is paying the bills:  the pharmaceutical industry, research universities, the federal government, etc.  And medical researchers understandably feel the need to prevent too much questioning and investigation of what they do.

In the case of the SUPPORT trial, the apologists have tried to shift the terms of the debate.  Normally, this is a very effective strategy.  But this is what you need to know, which the apologists are doing quite a dance to obscure, and will never discuss:

1.  Some or most mothers of preemies were asked to provide "informed consent" -- while they were in labor!  How can you possibly give thoughtful consideration to subjecting your about-to-be-born, very premature baby to medical research while you are in the midst of trying to deliver that baby?  Clearly there was no true informed consent under these circumstances.  Have the bioethicists, and researchers who came up with this plan, ever experienced labor?

Another major issue wrt informed consent was that the trial objectives and strategies were not accurately explained in the consent document.  Here is the consent form.

2.  The design of the trial was bizarre.  The "pulse oximeter" that is used to continuously record blood oxygen levels was redesigned to provide inaccurate values for blood oxygen levels in the babies.  The result was that treating physicians were given false values of oxygen saturation in the babies.  Clearly, this might and probably did interfere with babies receiving optimal, individualized adjustments of oxygen delivery.  Would you want doctors in an intensive care unit treating you to get altered, inaccurate test results?

3.  Since the treating doctors were given incorrect information, the trial results are based on abnormal circumstances and altered physician responses, which throws into question whether the results are of any value at improving clinical practice.

Why didn't the participating physicians, institutional review boards and medical centers notice these failings?  Because that is how things are, with no one really responsible for getting it right, despite the fact that it is humans who offer themselves and their children up to the research enterprise.

Thank Public Citizen and AHRP for calling attention to these serious lapses in medical research on critically ill, newborn humans.

Time to learn what is in the vaccines you receive

Two years ago a bill was brought to the Maine legislature asking for a list of ingredients to be provided to parents with each childhood vaccination.  I wrote in support of it then.

A similar bill was again presented in the legislature, and I have written again in its support.  I also enclosed a copy of the very popular CDC list of vaccine ingredients, annotated by me to identify the presence of animal or fetal-derived cells in vaccine production.  Here is the letter:

Meryl Nass, MD

Board Certified in Internal Medicine

5 Alexandra Rd.

Southwest Harbor, Maine 04679

207 522-5229 C   207 244-9165 W

May 4, 2013

Dear Maine HHS Committee Member:

I wanted to comment on LD 754, a bill that would require that a list of vaccine ingredients be provided to parents when their children are vaccinated.  I practice medicine in Maine and am an expert on anthrax vaccine. An abbreviated CV is attached.

It is important that both recipients and medical providers be well-educated regarding vaccines, in order to make wise vaccine recommendations.  I was a licensed physician for 17 years before I learned anything about the composition, testing and licensing of vaccines.  I had, at most, a one hour lecture on vaccines in medical school.  I wonder how many other doctors are equally ill-informed?

1.  Medical providers are required by federal law to give parents or recipients a Vaccine Information Statement (VIS), a 2 page informational sheet prepared by CDC, with each of the following vaccines administered:

Ø     DTaP (includes DT)

Ø     Td/Tdap

Ø     Hib

Ø     hepatitis A

Ø     hepatitis B

Ø     HPV

Ø     influenza (inactivated and live vaccines)

Ø     MMR and MMRV

Ø     meningococcal

Ø     pneumococcal conjugate

Ø     polio

Ø     rotavirus

Ø     varicella 

The VIS mentions some, but not all, risks related to vaccines.  For example, the VIS for Hepatitis B vaccine mentions a potential allergy problem due to the presence of yeast in the vaccine, but does not mention that soy is also present, and it too is a common allergen.

Some vaccines contain eggs, which occasionally cause serious allergic reactions.  Some vaccines contain gelatin (prohibited for kosher Jews); others are made in [aborted] fetal cells or their derivatives, and some people may choose to avoid a vaccine for that reason.

Listing vaccine ingredients may not be necessary all the time.  But remember that FDA considers it important enough to require food manufacturers to list all ingredients on their packaging.  This enables consumers to choose which ingredients to avoid, whether due to allergy, a religious dictate or for any other reason.

2.  Hundreds of vaccines are in development, and they contain an array of new ingredients to stimulate increased immunity.  These ingredients do not have to be tested for their "stand-alone" toxicity:  their only required testing occurs during a clinical trial of the complete vaccine.  Most human vaccine studies

last only one month.  If no serious side effects are identified within that period, the candidate vaccine may be licensed.

However, this testing is insufficient to identify whether the vaccine or its components may cause or promote cancers.  (Many vaccines have never been tested for carcinogenicity, for example, although many contain formaldehyde, a known carcinogen.)  

Vaccine testing can miss birth defects that might be related to vaccination.  This is because pregnant women are not included in vaccine trials.  The HPV vaccine Gardasil was approved after a six-month, "fast-track" review by FDA.  Merck, the manufacturer, was asked by FDA to collect information on possible birth defects after approval.  The VIS for Gardasil vaccine says,

"Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer’s HPV-in-pregnancy registry at 800-986-8999. This will help us learn more about how pregnant women respond to the vaccine."

3.  In 2009-10, swine flu vaccines were made with and without novel adjuvants (new additives used to enhance the immune response), using abbreviated testing.  Novel adjuvants had not been used in previously licensed US vaccines.

Here is an important example of how an ingredient list would be beneficial to vaccine recipients:

The 2009 Pandemrix swine flu vaccine caused narcolepsy (at a rate 12 times greater than expected) in hundreds of children and young adults, and some other swine flu vaccines caused seizures.  Their use in children was stopped in some countries (Finland, Ireland and Australia).

Pandemrix used a novel adjuvant (named ASO3) to increase the vaccine's effectiveness.  ASO3 had not been used in children before, nor had it ever been used in the US.  It probably contributed to narcolepsy. A vaccine containing ASO3 is under consideration now by FDA for avian flu. I think it is very important that parents be informed when a vaccine that will be given to their child contains ASO3.

 

4.  Consider the difference between ingesting food and injecting vaccines.  Food has to pass through the gastrointestinal tract, which acts as a barrier against noxious substances entering the body, protecting us from harm.

Injections bypass all skin and mucosal barriers, overriding important protective mechanisms.  Substances injected into us therefore need even more careful vetting than is given to foods. Vaccines should be at least as safe as foods, and their components should be equally transparent.

5. Providing a list of ingredients at the time of inoculation will not add a large burden to medical providers or manufacturers.  The Vaccine Information Statement is already given out with most inoculations. An ingredient list is part of the vaccine package insert, which is included with each bottle of vaccine sold. This package insert or the list of vaccine ingredients it contains could easily be included along with the Vaccine Information Statement, when vaccinations are administered. 

Thank you for the opportunity to comment on this piece of legislation.

Sincerely,

Meryl Nass, M.D.