Quality Of Life

The concept of quality of life is difficult to define. Quality is an elusive term, which means many different things to many different people. In other words, a judgment of quality must be made. This judgment will differ considerably based on the one making the judgment. Some will judge quality based on the "sanctity" of life, which implies that "physical life be sustained under any condition for as long as possible (Jonsen et al., 2006, p. 111)." Quality of life is understood from both personal and observer evaluation. For example, the life of a one legged man may be judged not worth living by the athletic observer, who measures the quality such a life by the ability or inability to run, while the one legged man may have come to fully enjoy such a life now that he has discovered his intellectual prowess (Jonsen et al., 2006).

The medicine of enhancement is ethically suspicious. This area of medicine is full of judgment calls as to what should be considered improved quality of life. Whether it's the ability to enhance sexual or athletic performance or diminish the effects of aging, pharmaceutical companies are there to remind us all what the standard of quality "truly" means. We see the ads on television as constant reminders that we really shouldn't "disappoint our sexual partners" or "begin to show the 'ugly' signs of aging." Who hasn't seen a commercial describing the signs and symptoms of depression and thought, "Hey, that's me." It's no coincidence that the commercials always end with their projected emotional quality of life "standard," in which the now medicated patient is running through a field of daisies. The pharmaceutical industry is a master of thrusting these judgment calls upon us to the point where we can't help but feel completely inept and unsatisfied with our lives.

This "thrusting" of values upon us by the pharmaceutical industry has its origins in the current sad state of pharmaceutical big business. A recent LA Times article by Melody Petersen (2008), regarding "Big Pharma" reports:

Only now is it becoming clear that this business model couldn't work forever. The strategy had a flaw that executives have long ignored: It required extraordinary amounts of promotion at the expense of scientific creativity. To make the strategy work, the drug industry put its marketers in charge; scientists were given a back seat. Is it any wonder that executives at many companies have watched their pipelines of new drugs slow to a trickle? (p. 1)

While "Big Pharma" has run out of brilliant new drugs, slated to replace the old, they have stepped up their efforts to remarket their existing drugs under new indications or new formulations. Indeed, when new drugs are scarce, simply lower the bar and serve them to a larger population or reformulate to make them "better, faster, stronger." Instead of beefing up efforts to push the envelope of scientific discovery, drugs makers have replaced the scientist with the Harvard MBA (Petersen, 2008). As a result, they have been left scrambling to manage the financial fallout of such business practice. Indeed, according to Petersen, "…the strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth is finally starting to betray it." (Petersen, 2008)

Nothing could be more ethically suspect than the promotion of a drug on the basis of sheer profit, but this is exactly what Big Pharma is doing when they seek and find FDA approval for new indications. Such an example is the new indication for Cialis (a sexual performance drug akin to Viagra) to be taken every day rather than as needed for sexual intercourse.

If quality of life was truly important to pharmaceutical companies they would be interested in creating drugs for all socioeconomic groups, but this not the case. They typically target those markets with expendable income. The "blockbuster" sales tactic wins out when choosing which drug to place their bets on. Categories such as cholesterol management, depression, and constipation are the mainstays of choice (Petersen, 2008). For example, malaria is killing a child every 30 seconds in developing countries, yet the poor cannot support the high prices a blockbuster drug demands, hence very little money is earmarked for development of such drugs (Petersen, 2008). Moreover, medicines that treat diseases that afflict only a small number of patients are often left on the back burner because they cannot achieve the numbers necessary to sustain market share and momentum (Petersen, 2008).

This became clear when Bristol-Myers Squibb executives announced at a news conference in 2000 that they were embarking on what they called the "MegaDouble" business plan. To enhance the company's profits, executives ordered its scientists to work only on "mega-blockbusters," such as Lipitor. Scientists with blueprints for drugs promising a mere $100 million in annual sales had little choice but to box up their work and send it to the warehouse. (And executives are now perplexed about why they don't have enough new drugs) (p. 1).

There is no improvement in patient quality of life when drugs become more expensive and more people are dying from understudied medications. As companies struggle to meet the bottom line, they may lay off employees and place more of the financial burden onto the customer in the form of raising medication costs. There is enormous pressure placed on the pharmaceutical industry by stock holders to compete fiercely in the market place. This fierce competition often leads to premature launching of medicines. Indeed, in much the same way new movies are released, new "blockbuster" drugs must garner a large share of the market upon initial release or they could be doomed to a lesser market share (Petersen, 2008). But unlike the movies, some of these drugs are killing people by the thousands. Some drugs have been studied with only a few thousand subjects before they are launched. In many of these studies the data is barely marginal enough for FDA approval. Indeed, FDA "fast tracking" of certain products is not uncommon practice. Vioxx is perhaps the most notable and recent example of this unfortunate recipe for disaster. It was prescribed to over 20 million patients before Merck pulled it from the market in 2004 after reports that it doubled the risk of heart attack (Petersen, 2008). One FDA scientist estimated that Vioxx might have caused heart attacks or strokes in roughly 139,000 Americans and that 30% to 40% of them died (Petersen, 2008).

What's interesting here is that this author prescribed hundreds of tablets of Vioxx during its "glory days." Every one of his patients enjoyed an improved quality of life through significant reduction of musculoskeletal pain and luckily no one was harmed in this small subset of patients. However, 139, 000 patients in the general population suffered an adverse event or died from using the drug. While there was no indication in earlier studies that the drug would cause harm to such a large number of patients, perhaps a larger original study sample would have accounted for this deadly propensity and prevented this pharmaceutical catastrophe from occurring in the first place.