1.02.2005

The Changing Motives of Medicine

Celebrex, Vioxx, Paxil, Zoloft - we've all had contact with them in some form, whether it be through television, a doctor's office, or personal use. Every day we are reminded of the power of today's wonder drugs used to treat a plethora of problems from inflammation to depression, cure-alls which have become a mainstay for doctors everywhere. Thousands and thousands of case studies exist showing the miracles that these drugs can perform. However, while this group of miracle-working medicines has created a new, improved way of treating patients for doctors, it has also unleashed a much nastier beast into a once calm field - the ugly, underlying motive of money in the form of millions and even billions of dollars.

I am reminded of a dinner I attended during an internship with a medical doctor hosted by one of the major drug companies. The subject? Prior Authorization Forms for Cox-2 (anti-inflammatory drugs such as Celebrex, Bextra, and Vioxx) drugs. The restaurant? Probably the most expensive found in the rural town where I was staying. Each attending member - nurses, receptionists, doctors, and even lowly students like myself from about six different medical offices - was allowed to order from a menu with several meal selections - meals that I would later find out priced between $30 - $50. I opted for the garden salad, crab cakes, fresh steamed vegetables, and a rich chocolate brownie for dessert. The tables were filled with appetizers and bottles of the finest wine. After about 15 minutes of talking about the prior authorization forms, the dinner was finished and the doctors and office staff were allowed to talk amongst themselves. As we left, we were each handed a "goody bag" that included a coffee cup, some stretching device that I have yet to use, a name tag holder, note pads, pens, and a holder for the note pads. Each of these "goodies" was cleverly emblazoned with logos for the company's drugs. The point of this example? This drug company was willing to spend well over the thousand-dollar mark to speak for fifteen minutes and ensure that insurance companies would pay for their drugs in even a small, rural town. These drugs are huge, money-making machines for the companies involved. In the nine-month period before recent news this year, sales of Celebrex netted 3.2 billion dollars. Zoloft, used to treat different forms of depression, sold a value of almost 810 million dollars in one quarter. The sale of all of these drugs creates pharmaceutical companies with multi-billion dollar profits each year. As is always the case, this money creates power for these companies.

I also distinctly remember a question posed at that dinner. One of the doctors proudly raised up and asked, "what if I want to prescribe a higher dosage?"

"Well, sir," the representative said, "That's not an approved dosage."

"What the heck were you thinking?" a few of the other doctors chimed in with sarcastic laughs. They seemed as if the approved dosages were just a small amount of what was safe and worked for their patients.

Not anymore. None of the three major Cox-2 drugs can still boast a record without blemishes in the area of cardiovascular damage. Worries and concerns about problems such as heart attack along with large increases in blood pressure continue. Vioxx has been pulled off shelves and strong advice against prescribing the other two has been given by the FDA. Too little, too late. Many doctors, through medical reviews and other studies, have known about the problems involved with these drugs. In fact, even before the summer, studies were being published about the possible link between heart attack and the use of Vioxx. Even in 1999, three months after the debut of Celebrex, the Wall Street Journal published a story about ten deaths related to Celebrex, two of which were caused by heart attack. The withdrawl of Vioxx didn't happen until October, 2004. The warnings about Celebrex and Bextra came in December. Did the FDA know about these problems and do nothing about them?

A look at another scandal involving the FDA and major drug companies may hold the answer. Meet SSRIs, the class of drugs that is most widely prescribed. These drugs have been used to treat minor to severe depression with great efficiency - at least in adults. But when it comes to teenagers and children, these drugs apparently don't have the magical formula that they need. Doctors, for some time, have been prescribing these medicines, but studies produced over the last summer aroused suspicions of problems. It turns out that, in some children, these drugs can more than double suicide attempts and suicidal thoughts. The other catch? These medicines appear to help no more than a placebo. In other words, they are much more harmful than beneficial in children. When officials in the United Kingdom found out about the problems, they placed a ban on the use of these medicines in children. The FDA? Well, one of their officials advised the same sort of action. What happened to him? The FDA said that the results had no true and conclusive evidence, asked for another round of studies, and wouldn't even let this official testify in later hearings about the problem. The drug companies joined in the cover-up scandal, asking employees not to talk about the problems associated with the medicines. Now the FDA has placed warnings on the drugs about the problems with suicide. Too little, too late.

Other problems exist, too. When taking a drug to the FDA approval, drug companies get the easy way out. All trials produced on each drug are not necessarily published by the companies. In fact, this action isn't even mandatory. Therefore, the companies can pick and choose between the trials that are presented to the FDA. The problem? This means that if a trial shows negative results for the companies' new and hopeful "wonder drugs," it can be thrown out and another started. Trial after trial can be performed, until the desired results are generated. Then, if these "best" and "great" results are enough to impress the FDA, the drug can be approved. Drugs can then make it to the market, without the FDA or consumer ever knowing what the downsides to the medicines may be. Who knows if the medicine really works? After classes in statistics and science, this doesn't seem like a very fair way to conduct so-called "scientific trials,"
especially when it involves the patient's well-being.

Drug companies often hold share in major medical insurance companies, as well. The problem? Besdies being a huge conflict of interest, these companies push the use of their own drugs for any illness or problem the medicines will supposedly treat, no matter what the situation. Doctors are almost forced to prescribe these medicines when a patient has insur
ance through a largely drug company-owned insurance company. Alternative medicines may be used only as a last resort. Our medicine isn't working? Try increasing the dosage. Having adverse side effects? A smaller dosage might work. Wait, is this medicine or is this money?

Speaking of conflicts of interest, the cheif counsel of the FDA was formerly a drug industry lawyer.

Brown-nosing to doctors also seems to be a major problem. Things like the dinner mentioned above, pens, notepads, and all kinds of gear are just a few of the incentives given to doctors by drug representatives. These things are given in hopes that the doctor will think about the drug the next time he is prescribing, remember the incentives, and write the prescription for that drug based on the rewards. I gave you a pen, dinner, and notepads, don't you want to write a prescription for me?


Would you like cheaper drugs imported from Canada? Forget about it. At least that's what the federal government said. There are apparently too many safety risks involved. While I agree there may be safety issues, it doesn't seem like the government is willing to research these problems. Whose interests might they be protecting? I'm not so worried about the costs, though, because drug companies must pay for the research that they conduct. Largely, profit generated from American consumers funds this much-needed research which leads to many breakthroughs.

Medicine once centered around the needs and health of the patient. It was, one might say, a pure form of altruism. I am reminded of a story my father tells me often, pushing me to become a doctor. "The doctor in my town was the only person around with a car, so he took my mother to the nearest hospital to give birth to me. That's what being truly devoted to your patients is about. That's altruism. That's a man that deserves respect, son." Where has this type of care and concern for the patient gone? While many doctors maintain a "patient-first" attitude, I fear that we have largely forgotten the patient in this world of monopolies. The patient has become a second priority to the new motive for medicine: money. Sad, but true. Can something be done to stop this? Sure. Should something be done to stop this? Most definitely.






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