[Authored by Len Saputo, MD and Stacia Lansman, MD, with Byron Belitsos—October 22, 2009.] Our nearly sixty combined years of practicing medicine has taught us this, if anything: Be wary whenever “big pharma” is part of any health campaign from which it stands to profit. And this is all the more true when it comes to emergency immunizations like the swine flu vaccine, the most ambitious program of its kind since the anti-polio campaign of the 1950s. Like most everything else in modern medicine that concerns pharmaceuticals, the swine flu phenomenon is surrounded by worrying signs of questionable science, corporate-dominated politics, and medical dogmatism—in this case on a global scale.
The peril we face from this vaccination effort is, in one sense, even more concerning to us than the dangers posed by the typical pharmaceutical drug. Commercial drugs face the requirement of double-blind, placebo-controlled trials; yet, for reasons explained below, few vaccines ever go through such rigorous study. Only minimal safety testing has been done with the new nasal spray, featuring live H1N1 virus, which is produced for the government by MedImmune. Nothing close to a placebo-controlled trial has been done for the "dead" H1N1 vaccines now in use (primarily manufactured by Novartis, Glaxo Smith, and Sanofi-Pastuer). Indeed, the FDA even waived its already lax requirements for vaccine safety testing this summer, so as to make the H1N1 vaccines available in the shortest time under supposed emergency conditions.
Let’s step back for a moment and consider a few basic facts: The current strain of swine flu—a unique Type A influenza virus—is indeed highly contagious, but it is not more dangerous than the average flu; in fact, if corrected for seasonal variation, far more people die from regular influenza virus every day in the U.S. Those regular flu deaths average out to about 100 people per day (i,e, 36,000 per year), according to Centers for Disease Control and Prevention (CDC) statistics, while deaths from the new swine flu now average about 5 per day (again, with correction for seasonal variation).
The H1N1 strain was first observed in mid-April 2009 and was at first believed to be relatively weak. But beginning in May 2009, public officials in this country and at the WHO (World Health Organization) reversed themselves, and have since then consistently overstated the problem. Consider, for example the dire warning that emanated from the White House Office of Science and Technology Policy this summer: the virus would infect 30 to 50 percent of the population, put nearly 2 million in the hospital, and kill anywhere between 30,000 and 90,000. Yet, total deaths in the U.S. through mid-October are just a bit over 1000. And according to WHO data collected through October, year-to-date the death cases worldwide has amounted to no more than 6,000. (See flucount.org) Statistics from down-under countries like Australia and Argentina, which just experienced their winter season, strongly suggest that the infection is very contagious, yet relatively mild and somewhat less lethal than normal seasonal flu.
Further, although it is true that influenza viruses mutate quickly, there is no firm evidence that a more virulent strain of H1N1 will evolve. This phenomenon—known as antigenic shift—can occur in theory, but is highly unlikely. Much more possible is what is commonly seen with seasonal flu viruses: antigenic drift toward a less virulent strain.
But even if a more lethal strain does emerge, the current vaccine now being distributed worldwide will most likely be useless against it. That scenario would require the creation of a new vaccine to fight this new strain. Manufacturing and distributing such an updated vaccine, even under emergency conditions, would take at the very best four months. Leave aside the safety issues with a vaccine that has been hurried into use under emergency conditions.
For these and other reasons we detail below, we counsel readers—as we do our patients—to avoid participating in the vaccination program now under way, even when it is directed at your children. True, a genuine outbreak that is now being reported, even though it is based on unreliable data about the incidence of infections (2). Whatever the case, we urge everyone to bear in mind that the best Rx for preventing or dealing with any sort of infection is to follow well-known guidelines to boost one’s own immunity, as indicated later in this article.
As you begin to confront the decision to get immunized against the H1N1 virus, get yourself and your family to peak health, do your own research, and ask probing questions of public health officials and the media before getting inoculated with these largely untested and likely ineffective vaccines.
BUT WILL IT WORK?
A recent survey from the Harvard School of Public Health found that just 40 percent of adults say they are “absolutely certain” they will get the H1N1 vaccine. An additional 41 percent said they “will not get it.” Dr. Mehmet Oz, America’s own "celebrity TV physician,” confounded the debate even more, when in a recent interview on CNN he said he will get the vaccine, but that his wife and kids will not. Surveys also show that more than 50 percent of all health care workers nationwide, including nurses and physicians, do not plan to take the vaccine as well. Obviously, there are significant doubts across the country about both safety and efficacy.
So what does the science say, first of all, about efficacy? The evidence is very mixed, at best. Generally, we know that death rates from flu in the U.S. have not decreased for any age group since the early 1980s, when the flu vaccine use was stepped up dramatically.
A courageous article published in this month’s Atlantic, “Does the Vaccine Matter?” throws even more serious doubt on the efficacy of flu vaccine.
For example, it cites papers published in the International Journal of Epidemiology in 2006 that show that if one corrects for the “healthy user effect” (the concept that people who get vaccines are on the average healthier in the first place), flu vaccines do not reduce mortality at all.
Perhaps more damning to the flu-vaccine establishment is the following evidence, also cited in The Atlantic: In 2004, the manufacturers of that year’s flu vaccine happened to fall behind their production schedules for technical reasons, causing a 40 percent drop in immunization rates; nevertheless, mortality did not rise. In addition, complete vaccine “mismatches” have occurred twice. (This can happen because, each spring—from among the many strains that are emergent worldwide—experts choose three flu strains that they believe will become most prevalent by the coming winter; only these three are covered in that year’s vaccine.) In two years, 1968 and 1997, there was a complete miss. Yet, “death rates from all causes, including flu and the various illnesses it can exacerbate, did not budge,” reported The Atlantic. The article also cites Sumit Majumdar, a physician and researcher at the University of Alberta, in Canada, who explains that rising rates of vaccination of the elderly over the past two decades have not coincided with a lower overall mortality rate. “In 1989, only 15 percent of people over age 65 in the U.S. and Canada were vaccinated against flu. Today, more than 65 percent are immunized. Yet,” said Majumdar, “death rates among the elderly during flu season have increased rather than decreased.”
Perhaps most damaging to the case for swine flu vaccination is the research of Dr. Tom Jefferson, head of the flu-vaccine section of the Cochrane Collaboration, a prestigious international not-for-profit, independent research organization. Jefferson is widely recognized as the world’s leading authority on flu-vaccine literature, and is the convener of an international team of researchers who have combed through hundreds of flu-vaccine studies. “The vast majority of the studies were deeply flawed,” says Jefferson. He even goes on to call them “rubbish.”
The general problem with flu vaccinations, according to Jefferson, is as follows: Young, healthy people don’t need the flu vaccine for the same reason that they respond well to any vaccine—they can quickly produce antibodies; meanwhile, older people and people with immune disorders, who are most likely to die from flu, don’t respond well to flu vaccine because they don’t efficiently develop protective antibodies in the first place—vaccine or no vaccine. This has led to a crucial question, “Is it necessary for those whom it helps, and will it help those for whom it’s necessary?” The upshot of Jefferson’s findings is this: There is enough doubt in the statistics about the efficacy of mass flu immunization that something never yet done, placebo-controlled studies, are clearly needed. Yes, despite his extensive research, respected role, and strong logic, Jefferson’s conclusion is rejected out of hand by the world’s vaccine establishment. They declare that doing placebo-controlled trials is unethical, given that they “know” flu vaccines save lives. Countering this, Jefferson states that “the most unethical thing to do is to carry on business as usual.” (3)
And what about children? In this case, some placebo control has been carried out, oddly enough: A review of 51 studies covering 260,000 kids cited in the Cochrane Database showed no better response than from placebo to flu shots. In addition, a 2008 study published in the Archives of Pediatric & Adolescent Medicine showed no impact on hospitalizations or MD visits for children, during two flu seasons, from flu shots.
DOUBTS ABOUT THE SAFETY OF SWINE FLU IMMUNIZATION
Among the additional questions we all need to ask is: Is it possible that the new H1N1 vaccine now in production may be more dangerous than the swine flu itself? One thing is for sure: We have not have had sufficient time for adequate clinical trials, even of the kind normally done for vaccines. This has raised doubts throughout the population, and has even led to a successful legal effort on behalf of the health care workers of New York state—all of whom had been ordered to take the vaccine or lose their jobs. Arguments presented in this suit led a state judge to block this state requirement with a temporary restraining order. The lawsuit charges: “To date, the FDA has produced absolutely no scientific evidence documenting safety tests for any of these swine flu vaccines. There are no published studies, no records of any clinical trials, and no publicly available paper trail demonstrating that any safety testing was done whatsoever. There is no researcher who has publicly put their name on the record declaring the vaccines to be safe, and no FDA official has ever stated that scientifically-valid safety testing has ever been conducted on the vaccine / adjuvant combinations now being distributed across America.” (4)
These aren't just rhetorical charges by a plaintiff: In statements made to health professionals in late August, the CDC openly admitted a significant safety problem: It told them to assume that one in every 100,000 vaccine recipients will suffer serious side effects, resulting in as many as 30,000 serious or potentially lethal adverse reactions to the H1N1 vaccine.(5)
Warnings like this bring to mind a chilling precedent: During the great swine flu scare of 1976, 46 million Americans took the vaccine offered at the time, and over 4,000 ended up seeking damages which amounted to $3.5 billion. The situation that led to this shocking scenario in 1976 is eerily similar to the current scare. In those days, the CDC pushed for nationwide inoculation while yet admitting there were no confirmed cases of the flu. The program was suspended after it became clear that the vaccine was far more dangerous than the threat of the flu itself; only one person died from the flu, while 25 people perished because of the vaccine, and hundreds suffered from a debilitating type of paralysis known as the Guillain-Barre Syndrome. (6)
The current mass campaign is even more ambitious than the ill-fated 1976 effort. Even now, health officials are deploying the setting of local schools as a key locus of swine flu vaccination for Americans, beginning with children. As mentioned, the last time such a drastic nationwide immunization program occurred was in the mid-1950s, when the Salk vaccine was introduced. This is a truly historic moment in Ammerican public health.
An additional problem, always lurking in the background, is compelling evidence that leads us to mistrust the public health establishment in an environment of the corporate domination of politics. Dr. Len Saputo’s new book, A Return to Healing: Radical Health Care Reform and the Future of Medicine (Origin Press, September 2009), documents how pharmaceutical companies routinely profit off of unsafe and ineffective products—usually with complicity from government officials and especially the FDA, who are easily manipulated. And now Congress is doing it again: It gave $1.5 billion to swine flu vaccine makers in May for 250 million doses, while granting them an exemption from the normal FDA licensing process for vaccines, as indicated above.
One more trick: Pharma has learned lessons from numerous class action suits, so it also made sure that the swine flu legislation grants it immunity against liability for side effects from the new vaccine. The result is that these vaccine makers stand to make between $10 and $20 billion in the global market for swine flu vaccines, with no responsibility for tens of thousands of likely casualties! Increased sales of Tamiflu and Relenza (treatment for patients sick with flu that are widely thought to have potentially severe side effects and minimal effectiveness) will also no doubt result from the scare tactics used by World Health Organization (WHO) and the CDC.
DISTURBING QUESTIONS REMAIN
The WHO has labeled the H1N1 virus “unstoppable” and designated the threat a Level 6 pandemic, its highest possible classification; it is in fact the first influenza pandemic since 1968. But remember that the term pandemic only refers to prevalence, that is, the spread of the virus to multiple countries and regions. There is a huge difference between the threat posed by the appearance of a disease in multiple locations, and its severity. It would be terrifying if this pandemic was causing widespread morbidity and mortality; but the H1N1 virus is simply not proving to be virulent. Says Dr. Saputo: “it appears that WHO and the CDC are tracking and issuing dire warnings against an illness that is no more severe than an ordinary cold!”
Clinical experience also raises questions: Dr. Stacia Lansman, MD, a pediatric integrative specialist, describes this swine flu as one of the mildest she has seen in years. She states, “the children I have seen with swine flu this summer and fall are just not that sick. I consider a mass vaccination program aimed at children to be dangerous and misguided. The safety of this vaccine is not proven, and children, with their developing brains and organ systems, are among the most vulnerable when it comes to vaccinations. I wouldn’t give it my children or recommend it to my patients.”
Many have charged that this mandatory vaccine is a thinly veiled attempt to exaggerate and capitalize on a relatively innocuous pandemic in order to enrich the coffers of US pharmaceutical and security corporations. While not necessarily supporting such allegations, we once again invite Americans to stand back and question the prevailing government line and look closely at the industry response, including the resulting profit margins. A recent article in ABC News website, “Drugmakers, Doctors Rake in Billions Battling H1N1 Flu,” makes clear that fighting the flu is good for business. (7)
Nor would we entirely dismiss internet rumors that point to the possibility that the swine flu is a genetically engineered virus. This virus continues to be an unprecedented enigma for virologists. In the April 30, 2009 issue of Nature, a virologist was quoted as saying, ‘Where the hell it got all these genes from we don’t know.’” Extensive analysis of the virus has revealed that it contains the original 1918 H1N1 Spanish flu virus; the avian flu virus (bird flu); and two new H3N2 virus genes from Eurasia—a rather unlikely blend of elements, especially the 1918 virus. (8)
Last but not least is the issue of the safety of Thimerosal, a mercury-containing compound used to keep multiple-dose vials of swine flu vaccines sterile. While it is important to keep the spread of infection down, using a known neurotoxin as a disinfectant that is also an immunosuppressant seems especially unwise. Readers should be advised that there is an ongoing battle between the CDC and the EPA (Environmental Protection Agency) about the safety of mercury-containing disinfectants, especially in young children, where the relationship between autism and Thimerosal remains unresolved. (Fortunately, those getting the H1N1 vaccine have the option of avoiding Thimerosal by simply asking for a rendition of the vaccine that does not contain it.)
Through the coming months, debate will continue over how it is possible for this unlikely combination of viruses to have evolved naturally, and especially over the trustworthiness of our own government and the pharmaceutical companies who will be calling upon each of us to make an important decision about our own health, and that of our families and loved ones. ###
Boxed insert:
SWINE FLU PREVENTIVE MEASURES FOR CHILDREN AND ADULTS
Dr. Lansman has had excellent results in preventing and managing flu symptoms with a range of vitamins, supplements, herbs, and homeopathic preparations. Her basic recommendations include 400 IUs of vitamin D each day for infants and toddlers, and 800 IU daily for older children. She also recommends Elderberry once daily and one dose of homeopathic Oscillococinnum each month. Dr. Saputo’s recommendations for adults include the following:
• Adopt a healthy lifestyle: adequate sleep, good diet, regular exercise, avoid stress
• Get plenty of sunshine, or supplement to keep vitamin D levels adequate
• Wash your hands frequently with water
• Consider boosting immunity with vitamin C, beta glucans, echinacea, vitamin A, maitake and shitake mushroom extracts, minerals such as selenium and zinc, certain herbs such as olive leaf extract and garlic, and homeopathic remedies.
FOOTNOTES
(1) See current statistics and official background information on H1N1 at the Centers for Disease Control and Prevention website at this link: http://www.cdc.gov/H1n1flu/update.htm
(2) Member nations of the WHO are not required to report incidence of the swine flu, nor even validate numbers they do report with lab testing. Numerous reports indicate that the incidence of swine flu cases are no longer being monitored. See for example: “US, other nations stop counting pandemic flu cases” Associated Press, October 11, 2009. In addition, according to a review by Dr. Tom Jefferson, head of the flu vaccine section of the respected Cochrane Collaboration, when doctors determine that a patient’s symptoms are consistent with flu, they are wrong on average over 90% of the time. http://www.theatlantic.com/doc/200910u/h1h1-qa) See also this story: “Swine Flu Cases Overestimated? CBS News Exclusive: Study Of State Results Finds H1N1 Not As Prevalent As Feared” By Sharyl Attkisson
(3) Shannon Brownlee and Jeanne Lenzer, The Atlantic, “Does the Vaccine Matter?” (November, 2009). Shannon Brownlee is a senior research fellow at the New America Foundation and the author of Overtreated (2007). Jeanne Lenzer is an investigative journalist and a frequent contributor to the British medical journal BMJ.
See also:“Dr Oz's Children Will NOT be Receiving H1N1 Vaccine”—http://www.youtube.com/watch?v=M_rKKawZx0I
(4) See: “Law Suit against Swine Flu Vaccine-FDA-Launched” at http://politicolnews.com/law-suit-on-swine-flu-vaccine and “New York judge blocks mandated swine flu” at http://www.reuters.com/article/idUSTRE59F51420091016
(5) Herb Newborg, “CDC States H1N1 Vaccine May Maim and Kill 30,000 Americans, FDA Requires Minimal Efficacy,” Global Research, August 28, 2009. http://www.globalresearch.ca/index.php?context=va&aid=14950
(6) For the whole story, watch this video of a 1979 episode of 60 Minutes:
http://articles.mercola.com/sites/articles/archive/2009/07/16/Major-Expo...
(7) Published October 14 at: http://abcnews.go.com/Business/big-business-swine-flu/story?id=8820642
(8) Declan Butler, “Swine flu goes global: New influenza virus tests pandemic emergency preparedness,” Nature 458, 1082-1083 (April 29, 2009). http://www.nature.com/news/2009/090429/full/4581082a.html
ABOUT THE AUTHORS
By Len Saputo, MD, a graduate of Duke University Medical School, is founder and director of the Health Medicine Center, Walnut Creek, CA, and author of A Return to Healing: Radical Health Care Reform and the Future of Medicine (Origin Press, 2009). See www.AReturnToHealing.com.
Stacia Lansman, MD, a graduate of Tufts University Medical School, is founder and co director of Pediatric Alternatives in Mill Valley, CA. See www.pediatricalternatives.com.
Byron Belitsos is a journalist, and the cowriter of A Return to Healing.
