Wednesday, January 28, 2009

Infectious Mononucleosis: The Annie of Diseases?
By: Lisa Menard

In an article published on January 21, 2009, Carolyn Sayre introduced us to a teenager named Chelsea Day and her struggles with infectious mononucleosis. We soon find that Chelsea is just one of many who are affected by the disease. For the 35 to 40 percent of adolescents and young adults who develop symptoms, this disease has a major impact on their quality of life; however, according to Dr. Robert Frenck, mono is a disease that "doesn't get the respect it deserves."

Mononucleosis, or mono, is also known as "the kissing disease" because it is spread by close contact. About 95 percent of adults in the U.S. have been infected with Epstein-Barr, the herpes virus that causes mono, by age 35 to 40; however, most people who become infected with Epstein-Barr virus never develop symptoms.

Since mono is so common, some experts fear the disease has become trivialized among physicians and the research community; however, mono is anything but trivial for the young people who get it.

There is still no vaccine or antiviral drug that can ward off Epstein-Barr virus or treat the resulting infection; there simply isn’t enough demand for a vaccine to warrant expensive research. Dr. Gary Simon agreed with this mentality when he stated, “There are more serious things. In general, this is a self-limited illness; 99.9 percent of people will get better.”

On the other hand, Dr. Hank Balfour, who agrees that further research is warranted, blames big pharma for the orphan situation. According to Dr. Balfour, “If they (big pharma) don’t see it as a blockbuster, then they don’t want anything to do with it.”

I agree with Dr. Balfour's views, but only to a certain degree. Is this a disease that deserves further research? Yes. Is the study of mono an orphan situation? Yes. However, this is also the point where I tend to disagree with Dr. Balfour.

The study of the disease is not an orphan situation because of big pharma's desire for blockbuster drugs; rather it is an orphan situation because of Dr. Simon's main point; there are more serious things and 99.9 percent of the people will get better. Can we say the same for cancer, heart disease, or HIV/AIDS?

Orphan diseases are rarely studied for a reason. Teenagers such as Chelsea Day may feel that it is unjust that her suffering is trivialized; however, the decision is clear when we compare which action produces the most advantages and fewest disadvantages for the most people; this is where pharmacoeconomics comes into play.

If we are going to mention the topic of monetary value, then one must consider the cost versus benefit relationship. Money is being submersed into studies such as cancer and HIV/AIDS because these diseases have a more profound impact on the healthcare system as a whole. Think of it this way, which is greater: the cost of treating non-life threatening mono for a couple of months, or the years of treatments for cancer of HIV/AIDS?

Extending the monetary situation a little further, should orphan situations still be a topic of controversy? Incentives, such as tax credits and seven years of marketing exclusivity, make clinical research of rare diseases more feasible. In the case of mono, it may affect more than 200,000 persons in the U.S, but there is no expectation that the cost of developing a drug or vaccine will be recovered from sales; these incentives may make up the difference.

In the meantime, scientists such as Dr. Balfour are working on treatments to help patients recover faster; and last year, Belgian researchers reported the results of a mid-stage trial that limited the number of mono infections from 10 percent (control group) to 2 percent (study vaccine group). So, while the controversy still simmers, Chelsea Day and all of the future mono-sufferers can be assured that, "the sun will come out…tomorrow."

2 comments:

Donna Proszynski said...
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Donna Proszynski said...

I agree with this viewpoint and would take it further to point out that there are other orphan illnesses that are more permanent, insidious, and debilitating. While it is unfortunate that some are affected by mono more seriously than others, and their plight should certainly not be trivialized, there are more serious illnesses that desperately need research funds. It would be ideal if all pharmaceutical companies donated a portion of their profits to researching cures for little known but serious diseases, but I think it is probably more than a matter of money. The study group for such a clinical trial would be very limited and it would be difficult to determine statistical significance. The results would be very much dependent on clinical significance, but how would you determine that the treatment was really the reason for improvement? Research is extremely expensive and it takes years from the identification of the chemical entity to bringing it to market. Most drugs from mainstream studies don't even get IND or NDA approval. That is a very big gamble for something so costly that may never even be marketable. So, while it may be easy to pass judgement on the pharmaceutical industry (with some justification) this issue is far more complex than meets the eye.