The Moral Questions of Influenza

The term influenza comes from the Italian word for "miasma", or "bad air." It would indeed be an ill wind blowing over humanity if Avian Flu, or another variety, mutates to allow itself to spread from person to person. Mankind has experienced 31 influenza pandemics since 1580, or about one every 14 years. The last one occurred in 1968. We're due. The natural reaction is to prepare ourselves. Vaccines, anti-viral medications, hospital and medical facilities, public health infrastructure and the like are at the forefront of any preparation discussion. What often gets only nominal attention, however, are questions of morality and ethics. Decisions made early in the epidemic will affect the lives of millions of people. Scientists, doctors, and public health officials are best equipped to advise us on the mechanics of disease avoidance and therapy, but there are many perplexing questions on how to implement them. The best time to solve them is before the emergency strikes. Influenza is a chameleon among viral pathogens. It is an RNA virus whose genome copying enzymes are actually designed by nature to make mistakes. The wrong amino acid is often inserted into a protein. Most of these copying errors are harmless. Some cause death to the virus. But a few profoundly change the virus' antigenic makeup enabling it to infect at a higher rate and avoid the immune system. In preparing for a viral attack, we have no way of knowing precisely which enemy we are facing, what vaccine will work, and what anti-viral medicines will be effective. Even in the best of circumstances we can expect a shortage of medications for global use. What we have at the time will need to be rationed. The choices on how best to use them will be difficult, controversial, and challenging to our moral conscience. Some that immediately come to mind: If influenza breaks out on a massive scale in a developing country, do we send them some of our limited medications, or do we reserve what we have for our own use? Should travel restrictions be placed on an entire country if a serious type of influenza is found there? If so, who declares the quarantine, and who enforces it? How? If we do send medical supplies to a poor country, how do we ensure that a corrupt government doesn't use the material for its own monetary or political benefit? The best treatment for any infectious disease is to avoid getting it in the first place. The correct vaccine is very effective in preventing influenza. Unfortunately, given the virus's ability to change its identity, we don't now know what the correct vaccine is. Preparing an influenza vaccine by traditional methods takes time. The virus has to be cultivated in hens' eggs, incubated for several months, harvested, killed, and made safe for human injection. If we knew the structure of an infecting virus and started on a vaccine today with traditional methods, it would be 4 or 5 months before a product would be ready for use. That's too much time. Much work is being done on newer formulations of influenza vaccine. Many involve taking a part of an influenza virus, inserting it into another organism, and producing the specific vaccine that way. It's basic genetic engineering. The catch, of course, is that these newer methods of vaccine production, while able to produce a product more rapidly, are not proven in a large number of people. Even the safest vaccines have side effects. They directly affect the immune system, and each person's immune system is unique. Most of us can eat a full bag of peanuts and not have a problem. But a few people can just touch a peanut and go into a hyper-immune state called anaphylaxis and nearly die. Any vaccine given to millions of people can cause several to have very serious immunologic complications. At what point in an influenza threat do we decide to vaccinate millions of people? Should we use one of the newer, perhaps unproven, formulations of vaccine production, or wait for the more traditional one? Many people will refuse to be vaccinated. Should they be subject to any sort of quarantine or travel restrictions? How do we identify them? Influenza can be treated with several anti-viral drugs that directly inactivate the virus. One of them is called oseltamivir, also known by its trade name Tamiflu. This drug inactivates the protein called neurominidase that the virus uses to escape from the human cell. Neurominidase is the N in H5N1. But just like the rest of the virus the N can change by genetic mutation. So while Tamiflu may work today, the virus of tomorrow may be resistant to it. Should we stockpile hundreds of millions or billions of dollars worth of Tamiflu today, realizing that it may be useless when we need it? Like any medication Tamiflu has an expiration date. Expiration dates are conservative estimates of a product's shelf life. If a product outdates on November 2nd, is it all that bad on November 3rd? How about December 2nd? The drug doesn't just go bad overnight. Months or even years after expiration there is still some activity left. What do we do with outdated Tamiflu? Is it OK to give to someone who would otherwise get nothing with the hope that it will still do some good? How do we decide who gets the fresh stuff and who gets the outdated? The Swiss pharmaceutical company Roche holds a patent on Tamiflu. Should they be compelled to allow other companies to make the product? What is fair compensation to Roche? Tamiflu is no panacea. If you take it after you come down with influenza you don't get cured right away. You just don't get as sick. It works very well, though, in preventing you from getting the disease after you have been exposed to the virus. If Tamiflu is still effective against the virus, but in short supply, should we use it more for therapy in those already sick, or reserve it for contacts of infected people to prevent the spread of the virus? Newer anti-virals such as peramivir and A-315675 are in development. They seem to work on strains of virus that are resistant to Tamiflu. Usually new medications have to undergo rigorous testing before being allowed on the market. If we get into a real bind of Tamiflu resistant influenza, should these newer medications be allowed to be used before undergoing the usual scrutiny? If so, should anyone be held liable if something goes wrong? When we become seriously ill, the first place most of us head for is the nearest hospital. Unfortunately, we don't have any hospitals just sitting there waiting for the next flu pandemic. They are busy places even in times of no influenza. During a pandemic hospitals, and the communities they serve, will face a number of hard choices. The numbers of ill will exceed the bed capacity. The disease is highly infectious and staff and existing patients will be at risk of contracting the disease. Many people will show up in the emergency room to be tested, even if they simply have a common cold, overwhelming the staff. Should we designate a few hospitals in the community to become acute respiratory hospitals? If so, how do we decide which one(s)? Where do we put people who need hospitalization when no beds are available? Should hospital visitation rights be severely restricted to prevent the introduction of the virus into the hospital? Many people don't have health insurance. Do they receive the same level of care as those who do? How will the doctors and hospitals be compensated? Most of us get our information through the news media. With the current system news goes through several reporters and editors before reaching us. Should the government or some other agency be allowed to dictate the news about influenza, or should the current system be left alone? How do we correct misinformation? Should the news media be subject to some sort of oversight to prevent unnecessary panic? If conflicting opinions within the medical and public health community arise, what is the news media's role in reporting it? In this country we highly value our individual rights. During a severe epidemic, however, some of those rights must be suspended for the good of the community. Self-quarantine, travel restrictions, closure of schools and certain recreation and entertainment businesses will probably be necessary. What is the best way for law enforcement and public health officials to enforce these restrictions? Who decides which enterprises to close down and for how long? Should those businesses and communities that are the hardest hit by these rulings (think Las Vegas) be compensated for their economic loss? If so, how much? If essential business like grocery stores or pharmacies close out of fear, should they be forced to stay open? Those of us in the medical profession are very much aware of the threat of lawsuits. Defensive medicine is an established practice. How much laxity of current standards will be permitted to cope with an influenza emergency? If someone is given Tamiflu that is outdated and they die, can the hospital and the doctor be sued? Should the doctor who fears a lawsuit be sued for not cutting a corner or two? Most people living in a developed country today have never experienced a full-blown pandemic of influenza or anything else. Our laws, medical practices and public behavior have all developed assuming that infectious diseases are for the most part controllable and manageable. But an influenza epidemic with a death rate of 2.5% in a population with no immunity would profoundly alter the status quo. Preparing for a pandemic is not like retrofitting a bridge to meet earthquake standards. There are too many variables and unresolved questions. Now is the best time to consider not just the science, but also the ethics of the next pandemic.