Friday, May 31, 2013

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.

Wednesday, May 29, 2013

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:

World Health Organization (WHO) Director-General Margaret Chan looks on during a meeting on the SARS-like virus coronavirus (nCoV) situation on May 23, 2013 at the World Health Assembly in Geneva. (credit: FABRICE COFFRINI/AFP/Getty Images)

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? 

Tuesday, May 28, 2013

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? 

Thursday, May 23, 2013

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...

Tuesday, May 14, 2013

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.

Monday, May 6, 2013

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.

Meryl Nass, M.D.