The swine flu appeared this past spring and seemingly morphed into a worldwide contagion of global pandemic status overnight. Click HERE to see the timeline and recall the chronology of events. USA Today offers a U.S. map of confirmed swine flu cases by state.
H1N1 and Flu Vaccine FactsFACT 1:
Effectiveness of the flu vaccine is questioned. It does not appear to reduce flu-related hospitalizations in asthmatic children. Some question whether we fully understand the long-term effects and the tradeoffs we are making by getting an annual flu shot. There is no evidence flu vaccine works in infants and young children. Hospitalization rates are higher in children who get flu shots. Yet the CDC announced that the highest priority targets for the vaccine include children 6 to 59 months of age. And Secretary Sebelius agreed that schoolchildren should be first in line. For a good summary of the concerns related to swine flu vaccination, read Swine Flu: To Vaccinate Or Not by Marc Girard, MSc, MD, a consultant in drug monitoring and pharmacoepidemiology (European expert, AEXA).FACT 3:
Women who received influenza vaccine had the same risk for influenza-like illness compared with unvaccinated women, adjusting for women's age and week of delivery. When asthma visits were excluded from the outcome measure, we also found no difference in the risk of outpatient visits for vaccinated and unvaccinated women. Hospital admissions for influenza or pneumonia for women in the study population were quite rare and no women died of respiratory illness during pregnancy. Infants born to women who received influenza vaccination had the same risks for influenza or pneumonia admissions compared with infants born to unvaccinated women, adjusting for infant's gender, gestational age, week of birth, and birth facility.
Dr. Kent Holtorf, an infectious disease expert, is interviewed on Fox News saying: I have more concern about the swine flu vaccine than I do about the disease. And yet, in Health Day News, an NYU physician tells pregnant women: Any fear of vaccines is greatly outweighed by the benefit of being inoculated against an emerging virus. Who should pregnant women believe? What if the mom miscarries or the baby is born with birth defects? Should any physician or public health official make this very personal decision for you? Read Who Should Get the Swine Flu Vaccine? in Telegraph UK which describes some of the ethical issues facing governments during the upcoming months.
Flu vaccines have a controversial history. Many adults and health practitioners opt against receiving the shot and claim to feel worse after getting flu vaccines. Eileen Avery, MS, RN and Associate Director of the New York State Nurses Association recently delivered testimony to the State Hospital Review and Planning Council. New York's nurses say no to swine flu vaccines and the state regulation requiring every health-care worker to be vaccinated against H1N1. Flu vaccine package inserts list a worrisome array of adverse events that occur in temporal association with the shot, including paralysis, anaphylaxis, convulsions, thrombocytopenia and others. Studies demonstrate a causal relationship between influenza vaccine and Guillain Barre Syndrome. The 1976 swine flu vaccine campaign was a big failure
. The flu killed one person. The vaccine killed over two dozen people and sickened about 500. In Reflections on the 1976 Swine Flu Vaccine Program, the CDC admitted "expect the unexpected, it will always happen:"
- Children did not respond to the initial vaccine formulation,
- Liability for "untoward" events after vaccination became a major issue,
- "Excess" cases of Guillain-Barre syndrome appeared among recipients of the vaccine,
- The pandemic failed to appear.
And while they concluded that it is always better to overreact than underreact when it comes to public health, among the observations they offered:
- There was public suspicion that the program was politically motivated, rather than a public health response to a possible catastrophe,
- The decision to begin immunization was worthy of serious question and debate,
- All policy decisions entail risks or benefits to the decision maker; risks or benefits to those affected by the decision.
Watch this November 1979 episode of 60 Minutes, available on youtube as part 1 and part 2, on the 1976 swine flu vaccine campaign. Mike Wallace talks with President Gerald Ford, Judy Roberts (a victim injured by the vaccine) and David Sencer, MD, former head of the CDC who was responsible for the failed vaccination program and was compelled to resign in disgrace. Note the discussion about the safety concerns, lack of informed consent, and the provocative, fear-based television ads urging Americans to get vaccinated. Listen to Michael Hatwick, MD, responsible for 1976 swine flu vaccine surveillance, tell about the risk of vaccine-related neurological disorders that was evident from a review of the literature. Listen to Sencer say that no one ever warned him this could be possible.
Most H1N1 vaccine doses will likely contain controversial ingredients including thimerosal, the mercury-based preservative that was removed from most pediatric vaccines after a contentious and bitterly-fought battle pitting public health officials against parents and consumer safety activists. ABC News discusses thimerosal and the swine flu vaccine HERE, offering the CDC perspective and admitting that its inclusion will give some parents pause. There is also significant concern regarding the possible use of squalene-based adjuvants ASO4 and MF59 which were both used in the anthrax vaccine given to U.S. soldiers. Read what investigative journalist Gary Matsumoto thinks about squalene in vaccines. Adjuvants are used when we need more vaccine. It helps to make a smaller amount of antigenic viral material go a longer way by reducing the amount of vaccine needed per dose. Scientists know that adjuvants cause more injury so it's a troubling tradeoff for those who believe that the vaccine will work. More vaccine = more are protected = more vaccine-related injuries? Less vaccine = fewer are protected = fewer vaccine-related injuries? Dr. Joe Mercola tell us more about squalene HERE.
FACT 7: If you get H1N1, you will have either have lifelong immunity or you will be immune for a very long time. In fact, the elderly, who are usually a high priority target for the seasonal flu vaccine, are not for the swine flu vaccine. The elderly appear to have enhanced immunity due to prior exposure to a virus that is related to the one that we see now. A person who gets a specific influenza and recovers generally has immunity to that specific virus for a period of time, usually a decade or two says Dr. Otis Brawley, Chief Medical Officer, American Cancer Society. This fall, how many of the one million Americans who now have or had H1N1 will be told that they should have their antibody levels titered before getting the vaccine? And if the virus reassorts and mutates, then yes, it's possible that you would no longer be immune. But that also means that the vaccine, developed many months earlier based on the seed virus at that point in time, is also unlikely to work anymore.FACT 8:
FACT 9: Every state in the country has ordered swine flu vaccine and the CDC has committed to reporting every Friday on how much H1N1 vaccine is available to the states and how much has been ordered. To access your state's updated information, click on the CDC spreadsheet HERE. The CDC recommends that certain groups receive the vaccine first but they have declined to prioritize rankings within these targets. They include pregnant women, babies, school-aged children, young adults to age 24, and emergency and health care workers.
Recommended Websites and Articles
Helpful websites and articles as you conduct your research include:
Centers for Disease Control and Prevention
World Health Organization
U.S. Department of Health & Human Services
U.S. Department of Agriculture
Red Cross on Pandemic Flu
National Vaccine Information Center
60 Minutes - Part One and Part Two - November 4, 1979
The Washington Post - Officials Are Urged To Heed Lessons of 1976 Flu Outbreak, May 9, 2009
Contrarian voices to consider
Swine Flu: What I Believe by Catherine Austin Fitts
Fitts served as managing director and member of the board of directors of the Wall Street investment bank Dillon, Read & Co. Inc., as Assistant Secretary of Housing and Federal Housing Commissioner at the United States Department of Housing and Urban Development in the first Bush Administration
Bill Maher vs. The Flu Vaccine (New York Times)
Maher uses his comedic training to challenge the boundaries of politics and political correctness on national television. His September 25 Twitter post circled the globe.
Swine Flu, the CIA, and Fidel Castro (Beyond Chron) April 29, 2009
With... the tacit backing of the U.S. Central Intelligence Agency officials, operatives linked to anti-Castro terrorists introduced African swine fever virus into Cuba in 1971. - San Francisco Chronicle, January 10, 1977
Obama's H1N1 National Emergency Declaration Could Invoke FEMA Response To Pandemic - Opinion (Natural News) October 26, 2009
These preparations for large-scale medical triage tents and the emergency activation of FEMA have me worried that the American people haven't being told the whole story. "national emergency declaration" isn't necessary to waive hospital tent rules. Obama could have easily accomplished the same thing with an Executive Order, without having to invoke the National Emergencies Act or put FEMA in charge at all. He chose the emergency declaration for a specific reason. I guess we'll all have to wait and see what that real reason turns out to be.
Flu vaccine mistakes, injuries and casualties?The Centers for Disease Control and Prevention just issued new warnings and side effects from the H1N1 vaccine that you may want to consider (ABC15) 11/17/09. And on 11/23/09, the American Chronicle reported that adverse reactions to the swine flu vaccine soar.
- Arizona - Melissa Ellingson (Phoenix)
- New York - At least two Schoolchildren Vaccinated Without Parental Consent
- New York - Sean James Weisse (Kings Park)
- New York - Queens students ill after swine flu vaccine
- Virginia - Desiree Jennings (Ashburn)
Seasonal and Swine Flu Vaccine Package Inserts
Part of your flu vaccine research should include an advance review of the package inserts for the specific vaccines that you are evaluating. Vaccine package inserts disclose information from the manufacturer related to safety, efficacy and other details relating to licensure of the product. These include adverse events, clinical pharmacology (composition, uses, effects), and medical contraindications.
Swine Flu Vaccine Package Inserts
Seasonal Flu Vaccine Package Inserts
(Package inserts for all FDA-approved vaccines can be found HERE)
- CSL (AFLURIA)
- GlaxoSmithKline (Fluarix)
- GlaxoSmithKline (FluLaval)
- Novartis (Fluvirin)
- Sanofi (Fluzone)
- MedImmune (Flumist)
And HERE is the CDC's Vaccine Information Statement (VIS) on the H1N1 vaccine.
Vaccinating In Schools
Increased Risk of Mistakes. Since school personnel do not typically vaccinate children, there is an increased risk that medical mistakes will be made, particularly when considering expedited vaccination in a large group setting, and the possible need for more than one dose to be given several weeks apart. Potential errors include improper administration of vaccine, duplicate administration of seasonal and H1N1 vaccines, and administration of shots to children whose parents did not provide advance authorization. The New York Times and NBC New York reported at least two children were given swine flu vaccines without parental consent.
Special Medical Care Required. There is specialized medical care that may need to be offered. Some children are allergic to components of vaccines. Severe, even fatal, reactions to vaccine may occur in some. If school vaccinations are carried out, will qualified doctors or nurses be available to provide life-saving medical care on the spot? If a child dies on site, what protocols are in place to notify the parents? Would the vaccine campaign be halted? Would this traumatize children who witness the event or see ambulance and police cars on the school campus?
Specific Reporting Required. The National Childhood Vaccine Injury Act of 1986 outlined specific requirements including reporting to the Vaccine Adverse Events Reporting System. Will schools comply?
Who Pays For Injuries? When children are harmed or killed by government-mandated vaccines, they are eligible to file a claim with the National Vaccine Injury Compensation Program. President Obama has urged all Americans to get their swine flu shots. Secretary Sebelius says school kids to go first, with shots given in schools. No one has mentioned issues of liability and legal recourse. One thing we know, the vaccine industry is off the hook. We granted them liability protection over twenty years ago.
Children May Resist. Certain children may not cooperate with vaccinations being given in a school setting, particularly without a familiar doctor or parent present. This physical resistance can lead to unintentional injury to nurses, doctors, or children, and create unforeseen legal consequences for the schools and/or medical professionals giving the vaccines.
Contamination of Vials and Syringes. The injection-form H1N1 vaccines are mostly in multi-dose vials, and contain thimerosal (49.6% ethyl mercury). Injection syringes and needles will need to be replaced for every single vaccine recipient. If only the needle tips are changed, Hepatitis C, Hepatitis B, HIV, and other diseases can be easily spread amongst vaccine recipients. This recently occurred at a Long Island (NY) pain management practice: Growing Focus on Reused Medical Vials (New York Times). Bacterial contamination can also occur readily in these vials. The multi-dose vials must be shaken before each administration of vaccine to avoid giving the final recipient a bolus dose of thimerosal/mercury that is much greater than 25 mcg.
Dangers of Live Virus Vaccines. The nasal spray-form H1N1 vaccine (MedImmune) contains live attenuated virus. Viral shedding and contamination are always a risk with live virus vaccines. Administration of nasal spray vaccines in schools could lead to unintentional spreading of disease in the most vulnerable population segment, our children. Additionally, attenuated or weakened viruses have the ability to un-attenuate themselves, and cause the very disease they are expected to prevent. Regular seasonal Flu-Mist has caused death in some children, whether due to improper administration into the nasal mucosa, or a fatal neurologic reaction to the vaccine components as covered in this New York Times article. Seasonal Flu-Mist is contraindicated for children and adults with asthma and Multiple Sclerosis. These individuals would have to receive the shot version of the flu vaccine. It is likely this contraindication would apply to the H1N1 nasal spray vaccine as well. MedImmune just announced its live virus nasal spray vaccine is ready to ship end-September.
Real Time Monitoring. There will be a great need to properly evaluate side effects in children who receive the H1N1 vaccines on a county basis, a state basis and a national basis, to ensure the side effects from vaccine are not debilitating and severe, and do not outweigh their benefit. Is anything presently set up, or being set up, to monitor this? Who will have the power of law to make a decision to halt the vaccination campaign if a significant problem with the vaccine, or vaccines used, is identified? How quickly can they act? Note: the Swine Flu vaccination campaign of 1976 was halted after only 10 weeks as the severity of vaccine reactions, including at least 25 deaths from the vaccine,outweighed any vaccination benefits.
What should you do if your school decides to administer seasonal and/or swine flu vaccines?
Find out the details: which shots, when will they be administered, are parents able or required to be there.
Do your research. Investigate the different possible formulations. Request copies of package inserts to read prior to administration. Review whether your child might have family history of chronic disease, autoimmune or neurological disorders that might put her at risk, for the diseases and the vaccines.
Decide which, if any, shots that you will want your child to receive.
Write a letter to your children's school(s) regarding your specific requests, i.e., no vaccines or only one of the two flu shots. Request confirmation of their receipt of your letter.
Keep them home on those designated vaccination days if you do not want your children to be vaccinated in school. Mistakes are inevitable. The New York Times and NBC New York told us about at least two children were given swine flu vaccines without parental consent. Better safe...?
Accompany them if you want your children to be vaccinated in school, so you can be sure they receive what you want, so you can record the lot number and brand name of the vaccines received, and so you can offer some comfort to your children.
Express your concerns
. If you are worried about vaccinating in schools, consider writing a letter
to your school superintendent.
Protecting Your Family
Vaccines seem to be the only major tool in our public health officials' toolbox to combat the swine flu. Even though USA Today reports: Flu Vaccine For Fall Won't Protect Against Swine Flu, Reuters says that the First Defense Against Swine Flu is the Seasonal Flu Vaccine. Why is this? Why so much emphasis on vaccines?
Our prevailing model for understanding infectious disease morbidity, mortality and transmission is quite simple. It says that germs are static and cause disease. To deal with the disease, we must kill the germ. We use vaccines so our bodies will manufacture antibodies, dispatch the disease and develop immunity. There is one problem with the model, however. In every single epidemic, pandemic and plague, scientists have never been able to explain why some people contract the disease and die... and why others do not. The pat response that "some people are different" doesn't illuminate and certainly doesn't satisfy. Could it be that there are other mechanisms at work affecting the human immune system? If we understood them better, could they help arm us with safer, more effective and less costly tools to respond to all manner of infectious disease and of course the occasional global pandemic? No one is permitted to say that any natural substance is a substitute for vaccines. Setting aside the topic of vaccination for a moment, here's what we know about supporting the immune system naturally:
Eat Well. Your diet matters. Don't make your body slog through fast food burgers, fries and soda to hunt down the nutrition it needs. You know the drill. Start with lots of colorful fresh fruits and vegetables. Eat a good variety of them, don't forget the green leafy veggies, and steer towards organic produce to avoid the pesticides. When it comes to protein, go for high quality and non-animal when possible. This means a small amount of grass-fed and organic meat, wild-caught seafood and more nuts, seeds and beans. Drink a lot of pure spring water, about one ounce for each pound of body weight. If you use a reverse osmosis filter, add back minerals. If you drink tap water, try to filter out the chlorine and fluoride.
Get Up and Out. In moderation, exercise and sunshine are proven to be good for you.
Reduce Stress. Whether emotional or oxidative, our bodies experience stress the same way. It takes its toll on your immune system. Find out what works for you. Whether it's mediation and yoga or scrapbooking and photography, take your mind off your troubles and find a therapeutic outlet.
Snooze and Shower. A good night's sleep and consistent hygiene practices are also keys to keeping well. Your home is your castle but remember that staying clean and healthy isn't just about washing your hands and taking out the garbage. Take some time to learn about ways to reduce household toxicity, too. The products you bring into your home, from cleansers to furniture, might outgas or leave toxic chemical residues. Again, don't make your body work harder than it has to. If you are spending precious energy excreting toxins, you will have lowered reserves when the flu comes to town. And if you are wanting a hand sanitizer for you or your children, consider using something effective but a bit more gentle this season. Health food stores stock brands which rely upon effective essential oils. Or Dr.Larry Rosen tells you how you can make your own.
Supplement and Fortify. Beyond the basics of vitamin C and echinacea, we're learning more about the role of vitamins, herbs, nutritionals and homeopathy to support the immune system. Here's a short and incomplete list to consider researching for your family:
Vitamin D. Read about the work of John Jacob Cannell, MD and the Vitamin D Council. Pharmacological doses of vitamin D stimulates the body to make its own antimicrobial and antiviral peptides. It also plays a role in suppressing inflammation. Odds are that you're deficient. Seven out of ten children have low levels of vitamin D.
Probiotics and Transfer Factor. The role of probiotics in supporting gastrointestinal health is not new. Our GI tract represents about 70% of our entire immune system. New research points to a positive role for probiotic supplementation and the prevention of colds in children and can help those who are already ill with various conditions. Brands to consider include 4Life and Chisolm Biological Labs.
Precursors to Glutathione. Glutathione is described as the master antioxidant that assists the body in removing toxins. It is produced in the liver and plays a key role in intermediary metabolism, immune response and health. Supplementing with glutathione has been difficult because it is not well-absorbed through the GI tract. A new patented product called ProImmune contains the precursors to glutathione that help stimulate the body's production of intracellular glutathione.
Antioxidants. Vitamin C is a time-tested favorite but can cause diarrhea in large quantities so many people like to experiment with dosage. Green tea extract appears promising as a source of health-promoting antioxidants. And did you know that elderberries have been used for centuries to cure the symptoms of colds and the flu? They contain anthocyanins, a powerful flavonoid. Located in the pigment of this fruit, these antioxidants have the ability to stimulate your body's immune system to fight unwelcome invaders. In placebo-controlled, double-blind studies, sambucus has been found to effectively treat influenza. Elderberry inhibits neuraminidase, the enzyme used by the virus to spread infection to host cells. If you're curious, read more about it in Prevention, Wikipedia and Wildman Steve Brill.
None of the above advice is recommended as a substitute for medical treatment prescribed by your doctor and individuals should consult qualified medical professionals to determine appropriateness, including potential interactions with current medications.
Seven Health Providers' Views (plus "Dr. Microsoft")
(1) Dr. Donald Miller - cardiac surgeon
Donald Miller, MD explains in this 11/1/09 article why most MDs don't get the flu shot and we should avoid flu shots and get some sun instead. He mentions the financial conflicts of interest on the part of those making recommendations in the CDC's advisory committee. A growing number of immunologists and epidemiologists say the vaccine probably doesn't work very well for people over 70, the group that accounts for three-fourths of all flu deaths; and there is a lack of evidence that young children benefit from the flu shot. And he highlights what our community has been saying all along. Randomized controlled trials are the most reliable way to determine efficacy and safety of any given treatment. No randomized trials show that flu vaccines reduce mortality from flu or flu-related pneumonia. Some studies show it helps decrease the risk of contracting flu, but to put them into context: if 100 people get the vaccine, one person may benefit, but all 100 risk being harmed by the vaccine.
(2) Dr. Larry Rosen - pediatrician
Larry Rosen, MD is a board-certified pediatrician with a holistic, integrative practice. He offers us this article on Influenza: Considerations For Prevention and Treatment that appeared in the September 2009 issue of Greening Your Life, from the Deirdre Imus Environmental Center for Pediatric Oncology. He addresses the following questions:
- What is the swine flu and what makes it different from the regular flu?
- How bad is this new flu, really?
- I keep hearing about a new flu vaccine. Is this flu vaccine safe? Does it work?
- Are there other ways to prevent the flu?
- What's the best way to treat the flu?
(3) Dr. Sanjay Gupta - CNN medical correspondent
Sanjay Gupta, MD is CNN's Chief Medical Correspondent. And he offers the following "clear, concise answers about what a parent should do with a sick child," excerpted from Dr. Gupta Offers Advice to Parents on H1N1:
As things stand now, the vast majority of children who develop flu-like symptoms this fall will have a few miserable days, and nothing more. And those days are best spent at home -- not in the ER or a doctor's office.
If you are worried, you should call your pediatrician's office first. Don't take your child in without calling. Two reasons: Your child may not have H1N1, but could become exposed by being around sick children. And, after several hours of waiting, you are still likely to be told the basics -- plenty of fluids, rest and dose-appropriate acetaminophen for a fever. After all, it is still the flu we are talking about. Video Dr. Gupta talks preparedness with HHS Secretary Kathleen Sebelius.
One doctor told me a way to think about things that was helpful. He said "remove the term H1N1 from the equation." If your child had regular flu, would you take him to the hospital? If the answer is no, then don't take him/her to the hospital now.
Yes, hearing between 30,000 and 90,000 could die from H1N1 is scary, but keep in mind -- around 40,000 people die from the regular or seasonal flu every year. The numbers may not be that much different, yet there is not panic about the regular flu. As things look now, H1N1 is causing only mild to moderate illness, not the widespread deaths people are worried about.
There are some children who should be seen by their doctor.
• A baby younger than 12 weeks has a fever greater than 100.4F
• A child, older than 12 weeks has a fever for three days
• A child's fever returns after a 12-24 hour time period
• A child is not passing urine or making tears for more than six hours
• A child does not smile or show interest in playing for several hours
One point that was reinforced to me over and over again by the pediatricians is the best place for a sick child is at home. And, with regard to school -- after 24 fever-free hours without the aid of medications, he or she can go back.
• A child cannot speak while trying to breathe
• Has a blue or dark purple color to the nail beds, lips or gums
• Is not responding to you because he is too tired or weak
(4) Dr. Frank Rosenbloom, MD
Read Dr. Frank Rosenbloom's October 29, 2009 article: Swine Flu Panic In Perspective. After seeing hundreds of cases of "flu" in the past few months, only three were confirmed, genuine cases. Two of these cases were in physicians and one was in a nurse -- they had mild illness, recovered with symptomatic treatment. All of the other cases turned out be allergies, typical viral or bacterial, or the seasonal flu.
(5) Dr. Frank Lipman - director of Eleven Eleven Wellness Center
Frank Lipman, MD, is an integrative physician and the founder and director of Eleven Eleven Wellness
, a center focused on preventive health care and patient education. Read his Huffington Post article Swine Flu: What To Do
? Dr. Lipman summarizes his top five reasons for advising against the swine flu vaccine and offers fourteen power steps to strengthen your immune system.
(6) Marcella Piper-Terry - Defeat Autism Now! Practitioner
Marcella Piper-Terry, M.S. provides holistic coaching and information for families with autism, ADHD and other developmental disabilities. Read her blog post Treating The Flu Naturally. She lists a variety of homeopathic and other supplements she used to treat her nine-year old daughter when she contracted the swine flu. The closing lines of her post:
Purchasing enough supplements to cover every possible scenario during the flu season: $400....
Treating the flu without worrying about mercury or squalene from vaccinations: Priceless.
(7) Dr. Tedd Koren - chiropractor
Tedd Koren, DC is a doctor of chiropractic who researches, writes and lectures extensively on the subjects of vaccination safety, the history of childhood infectious diseases, and the role of chiropractic in supporting health. He shares with us this piece: What Can We Do To Protect Ourselves From the Flu? He looks to history to answer key questions about disease mortality rates and the effectiveness of various treatment modalities. He asks us if there is a role for illness in promoting long-term self-healing.
(8) Dr. Microsoft - web-based tool
How about turning to your computer for a little advice? Microsoft partnered with Emory University to deliver this interactive website: H1N1 Swine Flu Response Center. As reported by the Associated Press: Web tool helps advise when flu needs a doctor. You type in your age (for those over twelve) and answer questions about your symptoms and health status. The idea behind the tool is to prevent overcrowding in hospital emergency rooms by directing those who may be worried but are not so ill to stay home.
And if another mention of hygiene makes you roll your eyes, maybe you're ready for a little handwashing science. The British Medical Journal recently published the article: Physical Interventions To Interrupt Or Reduce The Spread Of Respiratory Viruses: Systematic Review. They cover various permutations of handwashing, barrier methods (i.e., masks), gargling, disinfection, and distancing.
There's a lot that's not known, about the disease, the shot, the programs to administer the shots, and your freedom to choose. The media headlines are certainly compelling enough to attract your attention, as they raise possibilities: hundreds of thousands killed by swine flu, military intervention, and storing the swine flu dead in freezer trucks. It's up to you to reconcile the information we have to-date, so you can decide how best to prepare and so you can also determine the extent to which we are all being primed or manipulated for what's to follow.
Here are some of the unknowns:
Is the disease worthy of a vaccine? This is the million dollar question, isn't it? Are you worried enough about what swine flu can do that you will accept the risk of the vaccine? As the virus passes through humans, it could adapt and become more mild. We've seen this happen with many other viruses that were once deadly. Or, not. The alternative scenario is that the virus mutates and becomes more virulent. It is this possibility that has attracted the attention and the mobilization our public health resources.
Did they get the shot right? That's on the CDC, for starters. They created the reference virus strain and sent it to the vaccine manufacturers. From what I've read, there is one strain and no antigen drift which is good news. That makes things easier. The novel A(H1N1) virus is a reassortment of four strains of influenza virus A: one from human, one from birds and two from pigs. When it comes to the seasonal flu vaccine, our researchers don't always choose well. It's rare when all three strains are a match. More often than not, they miss one or two and the vaccine is significantly less protective. Development of flu vaccines is tricky, due to these issues of ressortment and antigen drift. The more unstable proteins offer the strongest immune response because these play a greater role in the replication and intensity of the virus. The stable proteins do not afford strong immune protection but this can be enhanced with adjuvants. More on how to make a swine flu vaccine.
What's in the shot? The possibilities are worrisome and some of them have been discussed. But how do you have an intelligent discussion about the safety and efficacy of the unknown and the unconfirmed? There are five swine flu vaccine manufacturers identified: Novartis, GlaxoSmithKline, Sanofi Pasteur, CSL Biotherapies and MedImmune. Each company has its own area of expertise. and therefore, there are different vaccine formulations being manufactured: inactivated versus live virus vaccines, inclusion of mercury-based preservative, adjuvanted versus nonadjuvanted vaccines, and specifically the use of squalene-based adjuvants. Each formulation has its own safety considerations, each worthy of extensive dialogue and debate.
Who will get the shot? The CDC announced that pregnant women and young children under age five are among the primary targets. Secretary Sebelius announced that it is a voluntary program. But we also that that the rules could change. There are laws on the books that provide for extraordinary measures to be taken in the event of a public health emergency (Model States Emergency Health Powers Act). Under what circumstances would these laws be invoked? What would their implementation look like? How much time would there be to weigh in and effect change? Who's in charge anyway - the Department of Homeland Security or the Department of Health & Human Services? We do know that the Obama Administration is mulling new quarantine regulations, taking a look at rules that were first proposed by the Bush Administration about four years ago. At the time, these included a "provisional quarantine" of three business days for those suspected of having illnesses listed in a presidential executive order. Federal quarantines are highly unusual; the last two reported were in 2007 and 1963.
Will there be time for good safety studies to be done? It's important to know that our prevailing understanding about vaccine safety and efficacy is based largely upon clinical evidence. The large-scale, controlled studies have not been done and there is not clearly enough time to do them in time for this fast-tracked vaccine. Secretary Sebelius assured Americans on national TV: Tests will be done. We're going to listen to the science and not release a vaccine until we feel we got the dosage right and that it's safe and effective for people to be vaccinated. We know that it takes time to do studies with integrity. There are quality control issues relating to sterility, specification, storage and stability. There are preclinical trials on animals. All vaccine formulations under consideration need to be evaluated. In human clinical trials, you have to decide who to test. All ages? Healthy people only or sick people too? Do you test pregnant women and evaluate for birth defects? You also must decide for how long we follow the test subjects. Do you watch for five days to ensure it doesn't cause anaphylaxis or do you follow them for years to check for other health outcomes, including cancer, infertility and chronic illness? And human nature being what it is, in the face of a strict timeline and enormous institutional pressure to pull the trigger, what happens if something worrisome is uncovered? Whether it's a space shuttle launch or delivery of a pandemic flu vaccine, do you delay implementation or do you... go?
I can't tell you what to do and and no one else can either. Read Dr. Sears' recent blogpost
. He pretty much sums it up as he concludes: Worry or don't worry. It's up to you.
[The information and products contained herein are not warranted for any particular use and all warranties, expressed or implied, including fitness for any particular use are expressly disclaimed.]
If you're concerned about what you're hearing, if you're worried that there won't be time to weigh in once the facts are known, join others who are banding together to collaborate and take action now. Click HERE for the Swine Flu Letter Writing Campaign to President Obama. There are two versions of the letter; one for physicians and another for the rest of us. Check back regularly for updates and new campaigns.