Monday, November 9, 2009

H1N1 Vaccine

I've begun my series of blogs on vaccinations, H1N1 included, but it's still a work in progress. I know many people are very eager to hear about my perspective on the H1N1 vaccine now, as they are contemplating whether or not to vaccinate presently. For that reason, I'll make this post on my views of the H1N1 vaccine first, and then go into the details of the science of the H1N1 vaccine and vaccines in general on future posts.

First, please let me be clear: I do not believe people are bad if they decide to vaccinate or if they decide not to vaccinate. There is so much publicity on both sides of the issue, it makes it very difficult for intelligent well meaning parents to make decisions whether or not to vaccinate themselves and their children. The most important thing is to not get caught up in the hype, but to instead make well thought out decisions which you could be comfortable with the outcome.

Medicine is not a perfect science. People's bodies behave uniquely, and we don't understand everything about the human body- nor do we understand all the science in relation with the human body. We have, however, made significant progress in our understanding of things despite not knowing everything. We can reasonably be sure of patterns and how the body will behave. When we carry this onto a larger scale, we have the study of epidemiology and public health. In this field, we must decide what are generally good principles to take on how to keep a person healthy within the population. We can start with the easy ones.

Wash your hands! The H1N1 is a virus which gets carried on droplets and secretions. It is most often picked up by our hands, and then we touch our mouth, eyes, or some other part of our face to get infected. Washing our hands properly (soap, warm water, getting under nails and between fingers, and singing yankee doodle while doing it) will prevent so many people from getting sick. Coughing and sneezing into your elbow is also a good idea because you keep from getting your hands contaminated, and you also don't cough into the open for a droplet to hit someone else. Staying healthy, exercising, eating a well balanced diet, and taking vitamins if you need them will also go a long way. Be careful with which vitamins you take, because many aren't tested, there are no regulations to make sure you get the same amount of vitamin in each pill, and vitamins can still be dangerous. Vitamins are another blog post altogether, but they can be beneficial if used properly.

The H1N1 virus is a strain of influenza A. The H stands for hemagglutinin which helps the virus bind to the cell. The N stands for neuraminidase which is an enzyme that helps the virus trudge through the mucous in the respiratory tract. The numbers just help us classify the virus. In short, this is like any other flu virus except it seems to illicit a very strong immune reaction in healthy individuals. That is where most of the concern comes from: this H1N1 flu virus has been shown to cause significant illness and sometimes death in healthy individuals. Previously, we had seen significant illness and death mainly in children, the elderly, and other people without intact immune systems. The H1N1 virus, therefore, is a concern for even healthy individuals. Children are usually vaccinated for mainly two reasons: they are susceptible to infection because they don't have the reserve an adult has, and they are incredible vectors to pass illness onto others. The same illness which would be bothersome to a parent, could land a child in the hospital. Children don't have the same ability in the short term to take a substantial hit. We also know what kind of grubby little germ bags they can be. They seem to get into everything, get their hands on everything, and go everywhere. This can put the entire community at risk because the more exposure a person has to a virus, the more opportunity to get infected. The seasonal flu vaccine was given to children so they could be protected themselves, to keep from spreading flu to other kids, and to keep from getting grandma and grandpa infected. The seasonal flu was far more risky for grandma and grandpa, but now we're seeing H1N1 being just as risky for us as the seasonal flu is for our older individuals.

So what about this vaccine? The H1N1 vaccine is designed to expose your immune system to the protein sequences of the virus without actually getting the full viral infection. There are two forms: the injection and the intranasal. The injection is a killed virus and doesn't have any ability to cause infection whatsoever. The intranasal is a live attenuated virus, and has been so weakened that it cannot cause the full infection and its sequalae. It cannot mutate back to its original virulence, and does not infect other people. Studies have shown antibodies produced from people who have come in contact with a vaccinated individual, but not to the degree where immunity can form. That means someone around you who has gotten the vaccine can't make you immune, and can't get you sick.

Often, a person thinks they got the flu after the vaccine. They may have muscle aches, runny nose, even feel feverish with chills. They did not in fact get sick, but their immune system may be mounting a response to the vaccine because they had already been exposed to similar viral proteins prior to the vaccination. The body thinks it got infected, and charges up the immune system to fight the "infection." Keep in mind, care for the flu is supportive: tylenlol, liquids, rest, etc. The symptoms are far shorter than if a person actually caught the flu, because the person really didn't catch the flu. There is also the possibility a person got sick with something else around the time they got their flu shot. During flu season, many other bugs are going around at the same time. Any viral illness causes similar symptoms, and a person may get sick with the cold and feel as though their flu shot got them sick. That is the reason people aren't given the flu shot when they are sick. Not because it makes them sick or is dangerous, but because we don't want our patients to correlate being sick with getting the flu vaccine. Since the nasal spray is a live attenuated vaccine, it is more likely to get some of these symptoms: runny nose, headache, etc. The body will kill the virus within a couple days, and develop immunity to H1N1 thereafter.

Many of the conerns of the H1N1 vaccine are because it is a "new" "experimental" vaccine. This is in fact not true. A similar H1N1 vaccine was used in the 70's. A lot has changed since the 70's. Technology is better, the vaccines are more pure, and the virus has mutated so that the same vaccine wouldn't be effective for the current strain. It is true the H1N1 outbreak is relatively recent, so a different vaccine than the seasonal flu vaccine needed to be made. Flu vaccines are made at least a year in advance, where researchers study the strains of flu affecting Asia. From there, they choose the 3 most likely strains of flu to cause a problem to the general public the following year. There are tons of different flu strains in existance, and the flu vaccine does not protect a person from all of them. If the H1N1 outbreak were discovered sooner, the H1N1 vaccine would probably have been combined with the seasonal influenza vaccine.

Another concern is regarding additives. By far, the most commonly cited additive is thimerosal. Thimerosal is a mercury containing compound which is used as a preservative in vaccine bottles to prevent other contaminants (bacteria, fungus, etc.) from growing in multi-use vaccination containers. To make it cost effective, many vaccines have multiple doses in a bigger bottle rather than packaging each one separately. Prior to this additive, many people would get sick when vaccines from a contaminated bottle were continually being used to vaccinate people. Now, the concern has been raised from possible effects of the thimerosal.

It is unethical to inject doses of thimerosal into the human body to find a toxic dose. Animal studies have given us a better understanding of the effects of thimerosal. When thimerosal is injected into the body, it breaks down into ethylmercury. This is a mercury which contains a 2-carbon atom chain. Anything that contains carbon is called organic. This therefore, is an organic mercury. Contrast this to elemental mercury (inorganic mercury) which is purified mercury we see in thermometers (which we have all been taught is toxic). The reality is, you could drink all the mercury in a thermometer and probably be ok- though I don't recommend trying it. It has been proposed organic mercury is far more toxic than inorganic mercury. One important thing to realize is organic mercury may be ethyl mercury or methyl mercury.

Both ethyl mercury and methyl mercury freely distribute throughout all parts of the body. It is primarily excreted through feces. Toxic affects can be cumulative, and guidelines have been made to reduce exposure to mercury throughout life. Ethyl mercury takes about 2-3 weeks to clear, methyl mercury takes about 3 months to clear. Studies demonstrate mercury gas to be far more toxic than mercury solid or liquid. Most of our exposure is not mercury gas. Studies have not been performed extensively on ethyl mercury because it is not the primary form of exposure. Most exposure takes place by methyl mercury, although both appear to have similar effects, but different elimination profiles.

As I stated earlier, it is not ethical to intentionally dose someone with something you think may be toxic, so we can't test for toxicity that way. We can, however, study levels in people's bodies when they are exposed to mercury on their own. The most common form of mercury expsoure is ingestion by eating fish. 1 parts per billion (PPB) is equal to 1 microgram per kilogram. Tuna, for example, has 118 ppb. Salmon has 14 ppb. A H1N1 vaccine may contain up to 25 micrograms of mercury. The current standard by the FDA for maximum exposure is 187.5 micrograms of mercury via vaccination in the first 6 months of life. Quaker oatmeal has 0.350 ppb. Hershey's chocolate syrup has 0.257 ppb. Kellog's Nutragrain bars 0.180 ppb, Coca Cola 0.062 ppb.

As you can see, humans are exposed to mercury every day. We often ingest more mercury than what is included in vaccines. 90-95% of ingested methyl mercury is absorbed by the gastrointestinal tract. The mercury absorbed is freely distributed throughout the body, so arguments about the body's "natural" filtering process as opposed to injection by vaccine are ill-informed. Furthermore, the argument about mercury is often not comparing "apples to apples" and when actually studied properly, mercury included in vaccinations is far safer than ingested mercury because; ethyl mercury is eliminated by the body more quickly than methyl mercury, the damaging effects of mercury are primarily gaseous and not liquid, and deleterious effects "blamed" on thimerosal have not changed in incidence following elimination from many vaccinations (which will be discussed in the next paragraph).

Despite overwhelming evidence to the contrary, the non existent link between autism and vaccinations is often brought up. Multiple studies have been performed which do not demonstrate any link between autism and vaccinations. The most notable studies are from Denmark in which nearly half a million children over nearly a decade were divided into vaccinated and unvaccinated groups. There was no evidence of autism being linked to vaccinations in any way. The results were also posted in the New England Journal of Medicine November 7, 2002 edition. Of course, this was not the H1N1 vaccine, but multiple studies have continually failed to show a link between autism and vaccinations. Rather than citing all the studies, I will give my opinion on why people believe there is a link.

Autism is admittedly a very difficult and devastating disorder. It affects multiple areas of life, and may lead to profound social and educational deficits. No parent wants their child to have autism, and if their child does obtain the diagnosis of autism, they want a reason why. We do not have any definitive idea of what causes autism, and non knowing is very difficult for many people. Instead, we have a tendency to grasp at possible correlations. Vaccinations were stated to be a commonality between almost all autistic children. The problem is, having a birth mother and father is also a commonality in autistic children. The point is: correlation does not imply causation. Just because something is common, doesn't mean one thing caused the other. Thimerosal was stated to be the source of autistic risk in vaccinations, but following its removal from most vaccines in the 1970's, the incidence of autism has not decreased... it has increased!

Some vaccination opponents have cited extremely low autistic rates in the Amish. The Amish do not vaccinate, and therefore, vaccination opponents propose this as evidence of a link between autism and vaccinations. The problem is, just because something is not diagnosed, does not mean it does not exist. I currently practice in Amish country. The Amish have a type of insurance where they pool their money as a community. Before going to the hospital, they group of elders meet and decide if the condition warrants going to the hospital and spending the community money. The Amish do not rely upon government programs, so they do not have any incentive to go to the doctor and obtain the diagnosis of autism. It would be really difficult to disguise a severely autistic child amongst a group of regular children, so lack of diagnosis can't be entirely the story. What we have found, is the Amish community has significantly greater rates of mental retardation than the general population. This is the proposed discrepancy. Rather than diagnose the children with autism trait, autism spectrum, or any type of autism, they are grouped into the larger category of mental retardation.

Are there cases of children who are not immunized who still develop autism? The answer is yes, but far more people are vaccinated in the westernized world than unvaccinated. Furthermore, in countries where vaccines are not common, there are not sufficient medical resources to diagnose autism. The motivation for sending in medical teams to diagnose autism in third world countries would be purely academic, and would appear to be very distasteful when so many children are dying. A notable case would be the son of John Travolta. He was reported to have autism and not to have been vaccinated. Of course medical information is confidential, and the information released by the Travolta family may or may not be influenced by the church of Scientology. If you take all reported cases of autism at face value, the answer would be clearly that autism does occur in non vaccinated individuals.

We don't know what causes autism, and we don't know why the incidence is increasing. Possible factors for the increase are: increased understanding and propensity of diagnosing autism, greater population size, and increased funding and resources for those diagnosed with autism. Autism is a relatively new diagnosis and we are currently learning more about it. Developmental pediatrics has made substantial progress in understanding this disorder, and we are now better able to identify it than previously. It is possible the disorder was always there, but we now have labeled it and the incidence therefore is increasing. With greater population numbers, there is also greater chance of having individuals with autism. Just by having more people in general, we also have more people with autism. You can also see how resources in America have significantly increased for children with autism. Although this is beneficial for individuals with the disorder, the increased resources create an incentive to have the diagnosis made. Children with autism have the potential for special tutors, more time for exams, and financial assistance. As you can see, there is greater benefit to having the diagnosis of autism made, greater ability to make the diagnosis, and larger population to make the diagnosis from as potential alternative reasons for the increased incidence of autism.

Some complications which have been associated with the H1N1 vaccine are also a major concern for patients. One of the most distressing complications is Guillian Barre (GB). GB is a neurological syndrome with many variants. It is thought to be immune mediated where the body's own immune system attacks the nervous system. It has an incidence of less than 1 in 100,000 in the general pediatric population. The incidence following vaccination is about 1 in a million. Since it occurs without vaccinations, vaccinations are NOT the cause of GB. GB can occur with any viral illness, with a bacterial gastrointenstinal infection being the most common. A person can get GB from a flu or a cold. The most devastating effects are respiratory arrest (in which a person stops breathing), or paralysis. 13% require intubation and ventilation (being put on a breathing machine), and 60% are unable to walk. 79% experience neuropathic (stinging electric shock) pain. Symptoms are often transient in which they resolve within 6-12 months in 85% of cases. Death occurs in roughly 3% of cases. Understandably, this syndrome is distressing. I do want to point out it is exceedingly rare, but may occur. If you compare this to the H1N1 virus, the latest CDC report in November revealed 3,900 deaths, an incidence of 22 million, and 98,000 hospitalizations in America this year alone.

On a personal note, I have seen somewhere between 10-20 deaths from H1N1, and have a friend's brother who developed GB 24 hours following the H1N1 vaccination. He is currently not doing very well and may need to be intubated. It's one thing to look at the numbers as a scientist and give a recommendation. It's a different thing altogther as a human being and a doctor to put the numbers and real life together to make a recommendation.

Concerns have also been raised regarding vaccine dosing. In reality, there are pediatric and adult dosing concentrations, but concerns have been raised as to why vaccines are not weight based. First, vaccinations are not medications in the strict sense of the word. Medications are substances used to heal and return a person to their prior state of health. Vaccines are substances adminstered to prevent disease. The science is very different. In antibiotics, for example, we have terms of distribution, absorption, half-life, metabolism, elimination, dose-dependent, bacteriocidal, bacteriostatic, etc. These relate to pharmacokinetics/pharmacodynamics or the study of a drug on the body and vice versa. A vaccine is different because it is not a drug that kills anything or gets changed to kill anything. A vaccine presents a protein to the body's immune system just like us coming across things every day of our lives. We eat things, smell things, touch things, see things and our bodies respond to them. The body gets exposed to protein sequences in a vaccine and remembers them so it can protect itself when the real virus comes along. In real life, we don't choose to be exposed to 1 virus or 1000 viruses. It just happens. How much of the ocean do you have to drink to know it's salty? Once again, the argument is comparing "apples and oranges." We don't weight base vaccinations because they are not medications.

Why the fears? If scientific studies, expert opinion, and the test of time demonstrate vaccinations to be safe and effective, why is there still so much contraversy? I believe the problem, of course, is the media, hollywood, and the government. For those of you who know me well or have read my other posts, this is where the politics come in =). The media has always pushed an agenda. Disguised as entertainment and rationalized as art, the media has introduced many dark sides to the general public. Death, torture, gratuitous sex, drugs, violence, etc. have all become images we see daily- even hourly. To make things worse, these entities have even become glorified. After turning what is right, pure, and good into perversion, people become mystified to the point where hollywood and the media are able to then push the irrational as fact. They combine the surrealism already portrayed in movies with plays on our hopes and fears to encourage us to make irrational decisions. The media similarly uses sensationalist stories to make the most rare obscurities a seemingly every day occurence. More driven towards ratings than responsible journalism, they persuade the public through graphic images to make irrational decisions.

We would hope the government would take a responsible stance to encourage the public to make rational decisions for their safety. The problem, however, is the government has allied with the media in different instances (the most recent presidential elections, for example), to lose all credibility with the general public. When combined with apparent attempts for government control, we now see how a healthy skepticism of the government has disuaded the public from vaccinations. Previously, the "hippy" "liberals" were the strongest opponents of vaccinations. With the recent intense distrust of the government, we now see the right wing conservatives as large opponents of vaccinations. When the government starts mandating individuals (as it did in New York) to become vaccinated, the immediate response is "hell no." None of us like being told what to do. Anti-big government conservatives absolutely don't want to be told by the government to be vaccinated. With both conservatives and liberals against vaccinations, it does not take long before the moderates follow suit.

To round out the opposition to vaccinations, the public has a profound (and somewhat warranted) distrust of pharmaceutical companies. As seen in the proposed health care reform bill, and current health care ledgers, pharmaceutical companies make a substantial profit off the American public. I have often met with my representatives and senators to express concern of this conflict of interest and the detrimental effects of allowing pharmaceutical companies to continue this trend. Rather than listening to myself and others who have the same concern, the government decided to position themselves in a way to also make a profit. After not trusting the government and pharmaceutical companies independently, there's almost no reason to trust them together. Despite my firm discontentment with the government and pharmaceutical industry, I tend to agree with the decision to vaccinate. Pharmaceutical companies stand to profit when medications are brand name. When they are generic and off patent, the profit margin significantly decreases. The cost to the public is between $10-20 per dose for the H1N1 vaccine. Many places will administer the vaccine for free. Contrast this with the brand name HPV vaccine which is more than $100 per dose and requires 3 doses. The government has accepted a contract with pharmaceutical agencies where the government incurs 40% of the cost. The reason the government subsidizes the manufacturing is because it would not be profitable for the pharmaceutical agencies to sell the vaccines without this joint venture. We all know the government doesn't do anything out of goodwill, so the government benefits through the millions of productivity hours gained by people not being sick with the flu. Additionally, the government doesn't have to pay for the hospital bills for the sick. If there ever were a win, win, win situation, this would be it. The business benefits with profit, the government benefits by saving money and productivity, the public benefits by staying healthy.

The latest fad is to go "green." Many individuals argue the biomolecular engineering of a vaccination is "messing with nature" and we should just use vitamins and have a healthy lifestyle. Although I agree with trying to maintain a healthy lifestyle, the problem with this argument is: natural does not mean safe, manufactured does not mean deadly/dangerous, and vitamins and a healthy lifestyle alone do not guarantee a disease-free existance. We know so many things which are "natural" and still harmful. Cocaine, marijuana, heroin are natural... and are illicit drugs! Millions of patients are hospitalized each year because of complications from vitamins! You can even drink yourself to death with water! Clearly, a balanced lifestyle is important, but to say green is safe is misleading and dangerous.

As an aside, the "green" agenda has benefited Al Gore millions. Additionally, albuterol inhalers were off patent and are a life-saver for asthmatics and patients with COPD. With the new regulations on CFC's, they have gone from being around $5 to around $50! That's a 1000% profit change for the pharmaceutical companies! Environmentalist cite the CFC's are harmful to the ozone. The problem is, the medication goes into the lungs and not the atmosphere! If you want to see how the government is getting their share of the profit, look at the cap and trade bill. By using "global warming" and "environmental protection" they are now taxing every manufacturer an additional amount. I believe it is important to protect the planet, but the weather cycles. The planet has been warmer and colder than this in the past. There is NO scientific evidence of global warming because it cannot by definition be scientifically tested. We cannot reproduce it, we cannot manipulate it, but as you can see, the government can take advantage of it!

On the flip side, manufacturing does not necessarily mean dangerous or deadly. Advances in engineering, production, and biochemical research have saved millions of lives. From stronger larger crops, to safer running water, to safety features on cars, technology has been shown to save lives. We have eliminated smallpox through vaccinations, and many other diseases are being eliminated also. Clearly, there are benefits to using the minds we have been given.

What if we eat naturally, take vitamins, and exercise? Does that keep us from getting sick? This should be a rhetorical question, but many believe it does. If you look at individuals who do their best to be vegan, do yoga, and stay clear of vaccines... they still get sick and die. Everybody dies at some point in their lives. There is a very large population of Amish near my hospital. Believe it or not, they still come to the hospital because they get sick. Before technological advances, settlers and native americans got sick. If you look at life expectancy from the past until now, it's pretty clear technological advances have increased length of life... and possibly quality of life independtly of vitamins and "green" living.

After careful consideration, I agree with vaccinating according to the CDC guidelines. (http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm) I don't believe individuals are "bad" if they don't vaccinate themselves or their families, but I do believe the benefits outweigh the risks. I am extremely skeptical about the H1N1 vaccine, but I do not find medical grounds for recommending against vaccination. I received both the seasonal and H1N1 influenza vaccines. I encounter sick patients every day, and it is extremely likely I will encounter a patient with H1N1 or the seasonal flu. As a duty to my patients, it is responsible for me to get the vaccines so I don't inadvertantly infect my patients who are unvaccinated and not infected. People have very valid concerns about the risks of the vaccine. Often, I believe the risks of vaccination are overstated or incorrect.There are risks in everything in life. We get in our cars every day and weigh the risk. Ultimately, the decision must be made by the individual. As I stated before, we as adults must make an adult decision weighing the risks and benefits. We must also take responsibility for the consequences. I believe the best and most responsible decision is an informed decision, and I hope my blog is helpful in achieving that decision.