Friday, September 18, 2009

Patient Preferences

The central theme of patient preference is the constant tension between the ideas of autonomy and paternalism. Autonomy has been defined as, "the moral right to choose and follow one's own plan of life and action (Jonsen et al., 2006, p. 52)." The idea of paternalism rests in assuming a position of authority over what is thought to be in the patient's best interest and thus ignoring that patient's preferences (Jonsen et al., 2006, p. 54). Unscrupulous clinicians, armed with biased information given to them by drug companies, might assume a paternalistic stance with their patients if those patients aren't convinced the drugs or products their provider is promoting are equal or on par with alternative, less expensive treatments. If the relationship between the drug rep and clinician is severely biased, either through close friendship or substantial financial incentive, the clinician may feel compelled to use his or her position of authority to override patient preference.

For example, a patient may come to the clinician wanting to control her hypothyroidism with a cost effective, generic brand of medication, but the clinician may be incentivized to recommend the "more accurately dosed" brand name. Despite evidence that there is, in this case, no significant difference between generic and brand name medication, the clinician will stand on the authority of his drug rep biased influence and convince the impressionable patient there is a "significant and clinically felt" difference. The patient may not have the money to afford the name brand, but now he or she is convinced that they must have the superior name brand if they are to "feel better." Under this undue influence, the patient is now ready to over-extend his or her budget to secure the medication. Of course, the clinician will attempt to ease the initial cost of the medicine with samples or coupons, but the patient will ultimately be made responsible for its costs when samples and coupon offers run out or expire.

Furthermore, because the clinician is in a position of authority, he or she will substantially contribute toward achieving a placebo effect in patients through the mere suggestion that a particular drug is better than another, thus strengthening the patient's belief in the fallacy. The patient may feel better not because of an actual drug effect, but by the mere suggestion of its superiority. Patients will thus continue to spend their money needlessly because they have been misled by their medical providers.

While it seems obvious to most that this kind of practice constitutes an obvious breach in medical ethics, it occurs all the time in clinical practice. It's this author's humble opinion that this kind of ethic continues to exist because it has been tolerated for so long and has been comfortably categorized as a "grey area" in medical ethics. Even while the patient has the full capacity to decide what he himself prefers, his preferences are ignored and overridden, and he is duped into believing the all too expensive or sometimes deadly (Vioxx) lie. All the while, through continued promotional campaigns, trumped up clinical trials, and paid physician endorsements pharmaceutical companies and clinicians share in the financial fanfare.

This breach of ethics brings to mind the ethical concepts of scope of disclosure, comprehension, and informed consent. It is important for patients to fully comprehend the decisions they are making. They can make these decisions if all the pertinent facts are fully disclosed them. If they are being intentionally or unintentionally misinformed, how then are they to fully comprehend the impact of their decisions? How are they to make informed consents? The sad fact is this-they are making misinformed consents.

Tuesday, August 25, 2009

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.

Thursday, October 30, 2008

How drunk are ya gonna get?

Only a person in North Dakota could think of this. From the county where drunk driving is considered a sport, comes this true story.

Recently a routine police patrol parked outside a bar in Minot , North Dakota after last call the officer noticed a man leaving the bar so apparently intoxicated that he could barely walk.

The man stumbled around the parking lot for a few minutes, with the officer quietly observing. After what seemed an eternity in which he tried his keys on five different vehicles, the man managed to find his car and fall into it. He sat there for a few minutes as a number of other patrons left the bar and d rove off.

Finally he started the car, switched the wipers on and off–it was a fine, dry summer night–, flicked the blinkers on and off a couple of times, honked the horn and then switched on the lights. He moved the vehicle forward a few inches, reversed a little and then remained still for a few more minutes as some more of the other patrons’ vehicles left.

At last, when his was the only car left in the parking lot, he pulled out and drove slowly down the road.

The police officer, having waited patiently all this time, now started up his patrol car, put on the flashing lights, promptly pulled the man over and administered a breathalyzer test.

To his amazement, the breathalyzer indicated no evidence that the man had consumed any alcohol at all!

Dumbfounded, the officer said, I’ll have to ask you to accompany me to the police station.

This breathalyzer equipment must be broken.”

“I doubt it,” said the truly proud Redneck. “Tonight I’m the designated decoy.”

Monday, October 20, 2008

Favourite Flower?

Many aspects of human sexuality are very puzzling, take celibacy.
This can be a choice in life, or a condition imposed by environmental factors.

While attending a Marriage Encounter Weekend, Robert and Mary listened to the instructor declare 'It is essential that husbands and wives know the things that are important to each other.'

He addressed the men. 'Can you each name and describe your wife's favourite flower?'
Robert leaned over, touched Mary's arm gently and whispered,

'Self-raising, isn't it?'

Thus began Robert's life of celibacy.

Friday, October 17, 2008

Turd terrorism is a wonderfull thing.

At the same retail organisation as previously mentioned, one of my good friends left the company to join another. We had a habit of sending odd stuff in the post to each other.. I felt I had to take it to another level.

Taking a latex doctors glove, I retired to the bog and crimped a turd into the glove. I then carefully squeezed the warm pooh into the fingers of the glove and tied off the end. Into an envelope and off she goes.

A few days later I got a call from my friend.. apparently on receipt of the envelope, realizing it was from me..and noticing an unpleasant smell.. he thought it best to open it behind closed doors and not in the shop as he normally would. I think I upset him a bit. He is a changed man.. though still my friend. We stopped exchanging gifts via the post.