| This may sound like a silly question, everyone knows | | | | which is believed to place someone at increased risk |
| what disease is. But have we ever bothered to | | | | for a disease. These risk factors may either be |
| define disease, or health for that matter. Right now, | | | | something which can't be changed, such as family |
| in the United States, there is an enormous political | | | | history, gender, or presence of a particular gene, or |
| debate about "health care delivery" which is, at least | | | | ones which can be changed such as the habit of |
| ostensibly, about improving the health of the citizens. | | | | smoking or having high blood pressure. |
| Is "health" though a commodity which can be | | | | These second type of risk factors are called |
| delivered by government? Throughout the world, | | | | "modifiable risk factors" and over the past half a |
| governments have enormous bureaucracies and | | | | century a tremendous amount of effort has been |
| departments tasked with addressing health and | | | | placed on attempting to change "modifiable risk |
| disease such as the National Institutes of Health and | | | | factors" so that disease doesn't occur in the first |
| the Centers for Disease Control. The US Food and | | | | place. While this is a noble goal, it is also one that is |
| Drug Administration by some estimates regulates | | | | more "risky" than simply treating a disease for a |
| some one sixth of the US economy, when it | | | | number of reasons. You see, by any definition, |
| approves a drug it does so based from clinical trials | | | | someone who only has a risk factor for a particular |
| which are intended to show a drug is both safe and | | | | disease, does not have the disease, therefore |
| effective against a particular disease. So again, why | | | | whatever "medicine" you are giving is not being given |
| don't we start at the very beginning and ask just | | | | to treat disease it is being given to a healthy person. |
| what is disease? When you think about it for a while | | | | All medicines carry with them a certain degree of risk |
| you begin to realize that, like defining "life", it is not at | | | | and it is a whole different proposition to be giving |
| all easy to define health or disease. | | | | medicine to a healthy person than to a sick person. If |
| For example, what a healthy 20 year old and a | | | | one was diagnosed with an incurable cancer and was |
| healthy 80 year old can do are generally much | | | | told a drug would give them a 50% chance of a cure |
| different. If a twenty year old could not run a mile | | | | but would triple their risk of a heart attack or |
| one would worry about disease, if an eighty year old | | | | increase their chance of having leukemia in later life |
| could run a mile we would be impressed. If one has a | | | | they likely wouldn't give a second thought to taking |
| broken leg, while one is not healthy, I don't know of | | | | the drug. If one the other hand, someone was in |
| any culture that would call them diseased. So, it is not | | | | good health and was told that a drug would give |
| simply diminishment, or even loss of function or ability | | | | them a 50% less chance of ever developing the |
| which defines disease. If the same individual however, | | | | cancer but it would triple their risk of heart attack it |
| had a broken leg not from falling off a ladder but as | | | | is an entirely different situation. If instead of |
| a consequence of cancer or a genetic condition, then | | | | preventing the cancer, the drug instead only prevents |
| we likely would speak of them as having disease. | | | | heartburn or joint pain and has no effect on risk of |
| How about a patient who has recovered from | | | | or progression of disease the risk/benefit scenario is |
| cancer, at what point is the disease no longer "in | | | | even further skewed away from wanting to take |
| remission" but instead the person is free of disease? | | | | the medicine. |
| What about carriers of infectious disease such as | | | | When you give medicine to a sick person it is |
| "typhoid Mary" or someone who doesn't realize they | | | | generally for a very limited period of time, i.e. until |
| have tuberculosis, do they themselves have disease? | | | | they get better. If you rely on a medicine to change |
| Suppose Typhoid Mary was a hermit who never | | | | a risk factor for disease they may be on it their |
| interacted with others, do they have disease at that | | | | whole lives. This again greatly increases the possibility |
| point? What about someone with latent or inactive | | | | of a serious side effect to occur from the medicine. |
| tuberculosis (this is some one third of the world | | | | The number of people with a risk factor for a |
| population), they have no effects from tuberculosis, | | | | disease will also be much larger than the number of |
| they are not contagious to others, yet, they may | | | | people with the actual disease. This means the |
| have a walled off cyst of live tuberculosis bacteria | | | | number of people on the medicine will be very large |
| somewhere in their lungs. | | | | and even rare serious side effects may end up |
| Medical practitioners speak of the "signs" and | | | | affecting a large number of people. Moreover, for |
| "symptoms" of disease. The signs of disease are | | | | any one disease, there may be multiple modifiable risk |
| those changes appreciable to the senses which | | | | factors which might be treated pharmacologically. So |
| indicate disease. So, for instance, a fever is a sign of | | | | as is often the case, someone in perfect health may |
| disease, the crackles and wheezes heard through a | | | | be on multiple medicines to treat various risk factors |
| stethoscope are signs of disease. These signs of | | | | for disease. |
| disease are investigated in the physical exam and | | | | This again increases the possibility of interactions |
| other diagnostic tests which may be ordered. The | | | | between the various medicines leading to an adverse |
| symptoms of disease on the other hand are what | | | | event. Finally, it is much more difficult to study and |
| the patient is experiencing. So a patient may say, I | | | | determine with any confidence whether treating |
| feel chills, when the physical exam finds a fever, or I | | | | someone with a risk factor for disease is actually |
| am coughing a lot when the exam hears wheezes in | | | | improving their long term health. For one, only a small |
| the lungs and the x-ray shows a picture of a fluid | | | | percentage of the people with a risk factor for |
| filled lung, or a child may say that their ear hurts and | | | | disease would be expected to develop the disease |
| looking at the ear with an otoscope the nurse or | | | | so the numbers involved to find any sort of possible |
| doctor sees an inflamed middle ear. Sometimes, the | | | | difference between treated and untreated groups |
| patient will have symptoms of disease, when no | | | | must be very large. Secondly, the studies must be |
| signs of disease can be found, so for instance the | | | | very long term, over years or decades even to begin |
| patient says, I have a headache and after an exam | | | | to get an idea of who might develop disease. |
| turns up nothing unusual the doctor says take two | | | | Because of these logistical problems there won't be a |
| aspirin and call me in the morning. Other times there | | | | large number of confirmatory studies, and as with |
| can be signs of disease but no symptoms, so a | | | | any other scientific study one must be concerned |
| patient may go for an annual physical and though | | | | about the possibility of bias, especially if one is only |
| they feel healthy are told your blood sugar level is | | | | relying on a small number of studies. Even if one does |
| very high, you may have diabetes. | | | | improve the risk for developing a disease has one |
| I wanted to start with this philosophical look at | | | | improved overall health. As has often been the case |
| disease so as to present two arguments. First, | | | | only after a drug has been approved and been given |
| Western Medicine generally does a good job treating | | | | to millions of people does it become apparent that |
| disease and second most of what Western Medicine | | | | the damage outweighs any benefit. |
| does is not treatment of disease. The first point | | | | Tomorrow we will look more into the issue of giving |
| could be argued at length, I would just ask if you had | | | | medicine to healthy people as well as the related |
| a serious acute disease, say an appendicitis, where | | | | issue of treating the symptoms of a disease without |
| would you want it treated? The second point | | | | treating the disease itself and conclude with a |
| requires some more discussion to be taken seriously. | | | | modest proposal for how to change the drug review |
| To do this we need to introduce some more medical | | | | process. |
| terminology. A "risk factor" for a disease is something | | | | |