Expensive pills hard to swallow
I hate the exorbitant prices of prescription medications just as much as the next person, and have done my fair share of grumbling when I witness commonly used drugs ring up at hundreds or thousands of dollars per month for patients at the local pharmacy. When I read about the current health care reform efforts, I feel nothing but the deepest sympathy for those who report having to choose between paying for their medications and putting food on the table. However, I do believe that there is solid justification for the high cost of drugs in our country, and for why Big Pharma should not be seen as the major culprit in the exponential rise in health care costs in recent years. I should also add before I begin that I have no plans to pursue a career in the pharmaceutical industry.
One of the root causes of the high price of medications is the enormous cost of research and development that is absorbed by the pharmaceutical companies in their efforts to come out with the next medical breakthrough. For the purposes of illustration, let's take the example of Targum Pharmaceuticals, a fictitious establishment in the pharmaceutical sector that is focused on producing drugs for diabetes, a disease of high blood sugar caused by a problem with the body's production or utilization of insulin.
The development of a new diabetes drug all begins with the careful selection of an internal target whose alteration will produce a reduction in blood sugar. From there, a large series of original compounds aimed at the target is designed through a long chain of chemical reactions. Before these compounds move on to the next stage of research, they are first submitted for patent approval and granted a patent life of 20 years. One of these compounds — let's call it Targumtrol — demonstrates positive results in the ensuing seven years of petri dish and animal experiments and is subsequently granted approval by the institutional review board to proceed to human trials. Throughout the next six years, Targumtrol repeatedly demonstrates advantageous data compared to placebo and currently available diabetes medications. So after 13 years and more than $1.3 billion spent on the development of this one compound alone, Targum Pharmaceuticals finally submits a New Drug Application to the Food and Drug Administration for the sale and marketing of Targumtrol and gets the nod of approval after a two-year review process.
This simplified timeline and cost description is representative of a typical pharmaceutical drug from its conception in the chemical laboratory to its approval for sale to the general public. And for every $1.3 billion that is spent on the successful development of a drug like Targumtrol, a good amount more is spent on the 5,000 or so compounds that hit a dead end at various stages of this long process. And if you haven't noticed yet, only five years remain from that original 20-year patent, which means that Targum Pharmaceuticals only has five years now to recuperate all of the investment that it made on Targumtrol and the thousands of failed compounds before generic drug companies can compete by introducing their own copies. Also, even though thousands of patients were evaluated for safety and efficacy in clinical trials, there are almost always side effects that are not detected either because they are extremely rare or because it takes many years for them to manifest. Case in point: Motrin can actually cause severe skin rash, ulcers, and double vision, but they occur very infrequently and do not outweigh the relief that this drug provides to the vast majority of individuals who take it. Who do you think ends up paying the tab for this vigilance?
While some point to the fact that many of the recently approved drugs are simply variations of what is already on the market as an indication that drug companies have been skimping out on research and development investments, a look at the numbers shows that an ever-increasing amount has been allocated to this area, with a record $65.2 billion being invested in 2008 alone. Simply put, it is becoming increasingly difficult to come up with the next breakthrough using the established "small molecule" drug approach, and companies are increasingly shifting their focus to "large molecule" biologics as the answer to many of the unmet problems in disease therapy. Imagine an elderly patient with Alzheimer's disease has a hard time remembering to take her osteoporosis pill every day — a variation of the same drug that allows the patient to take the pill once a month instead would provide more ease in allowing her to take the medication regularly.
True, research and development does not account for the entire budget of pharmaceutical companies, and a significant chunk of money is indeed spent on sales and marketing. While I am strongly opposed to many of the unscrupulous practices that were and are still prevalent among sales representatives in their interactions with physicians, such as the infamous "dine and dash" and "pump and go" routines — where physicians get treated to fancy meals and free gasoline, respectively, in exchange for prescribing certain medications — it should be noted that the industry is moving in the right direction with the explicit prohibition of such unethical practices in the Pharmaceutical Research and Manufacturers of America's new Code of Interaction with Healthcare Professionals that went into effect in January 2009. That means no more fancy meals, no more free gas, no more drug pens even. In an era where patients are increasingly encouraged to take an active role in their own health, it makes sense that they be provided balanced information of the new medications on the market that can help treat their disease. It is ultimately the responsibility of the physician and pharmacist to make the professional judgment as to whether the specific drug that the patient inquires about is appropriate for his or her needs.
Finally, Big Pharma has been heavily blamed during the recent health care reform efforts for being the key contributor to the ever-rising health care costs in our country — which reached $2.5 trillion last year and is expected to top $4.3 trillion by 2018. However, a look at the data shows that prescription drugs account for 10 percent of overall health care expenditures, while physician and hospital costs account for more than 50 percent. So even though $150 per month for a cholesterol drug is certainly a lot, compare this to the $15,000 hospital bill for each heart attack that may result from not controlling your cholesterol, not to mention the immeasurable emotional costs and impact on quality of life.
So as much as I hate the high prices of medications in our country, it's hard for me to hop on the big bad Pharma bandwagon. The next big cure may come, but unfortunately it won't come cheap.
Bo Wang is an Ernest Mario School of Pharmacy fifth-year student and president of the Pharmacy Governing Council.