People are growing more and more suspicious of prescription drugs. For one thing, many of those medications cost a fortune. Despite the fact that the United States Veteran’s Administration buys much of its formulary from Canada, the Bushies tried to make it illegal for mom and pop to order them online from that same country. Bunch of crap.
For another thing, people don’t like all the side effects. There’s a drug for everything, and they don’t always mix well. You’ve got the blood pressure pills (most people require more than one to control the pressure), the pee pill (usually because people have to pee too frequently), the pain pills, the sleeping pills, the hard-on pills, etc. The newest drugs are advertised on TV directly to the public, and despite the general mistrust, it seems as though people really hope that the newer drugs are better, and they come in asking for them.
Well remember this: most of the time those new drugs are not better. They’re what we in the biz call “me too” drugs, and they are closely related to another group of drugs which are already available, have been prescribed for millions, and are much less expensive. There are so many drugs out on the market, that your family doctor memorizes categories and families of drugs rather than individual ones. For example, you may be taking lisinopril. All your clinician needs to know is that “lisinopril” is from the family of ACE-inhibitors, and he or she knows the general effects, indications, side effects, and cautions. Honestly, that’s how it works, because we can’t memorize thousands of individual drugs. Even your pharmacist, whose only job is drugs, has to look things up sometimes.
You’ve heard the argument about why drugs are so expensive from Big Pharma: the research costs. Let me tell you about my experience with some of those expenses. I’ve been involved with pharmaceutical research for several years at more than one level, and I’m not convinced that the research process is so ethical. Here’s roughly how it works. The drug company decides it needs to make more money, so it hires some scientists to develop a compound to do a certain thing, for example make a penis erect for longer than 20 minutes. After dicking around (couldn’t resist) with the compound for a few months or years, probably based on one that’s already on the market, it’s ready to be tested in humans. Somehow the Principle Investigator for the research appears. This is usually a male doctor with a specialty in the field, say urology, who is affiliated with a prestigious university medical school.
The study is designed by the PI and a panel of others who must take into account that the research will be carried out by ordinary drones who aren’t really researchers, and it has to be done expeditiously. The study design details are submitted to the FDA, who says OK or not. The FDA may or may not like the design of the study, which is designed to get the drug to market as quickly as possible. Translate: make the drug look good so it’s released sooner. You can imagine the possible implications of a study that is designed to make the drug look effective. And a delay in getting to market can cost the Big Pharma upwards of a million dollars a day. It’s actually cheaper in some cases to get the drug released with known problematic side effects, and then to pull it off the market later after they can pocket some cash.
During the first phase of the study, a few subjects are tested in a hospital-like setting with 24/7 staff, frequent laboratory analysis, etc. After this phase, when the drug passes certain safety requirements, they go on to the next phases. The research design team decide that there must be so many subjects, say 500, and must represent a diverse example of the general population. So, they plan to conduct the study at 50 different sites, each of which must enroll 10 subjects. This is where the innocent drones like myself come in. The Big Pharma company doesn’t want to look biased, and they don’t want to hassle with the actual research at the later phases, so they hire a CRO, or Contract Research Organization, to run the study. This costs a lot of money. The CRO recruits individual sites, which may include your doctor’s office. Your doctor gets paid for this, sometimes quite generously. I’ve coordinated studies at the site level involving the sum of greater than $10,000 per patient, depending on the complexity of the study design. The sponsor and CRO incur all the costs of the study, and often patients are actually paid to participate. Don’t you think the sites are motivated to enroll patients? The site investigator might even be tempted to fudge a little on the enrollment criteria here and there to get patients in.
The FDA requires that the site study coordinators and investigators be properly trained to conduct the study, so the drug companies have “investigator meetings.” These are usually weekend trips in five-star resorts somewhere nice, like West Palm Beach in January. No shit. They fly you in, feed you tons of fantastic food with entertainment and wine, just to do Power Point presentations to show you how to fill in the forms. I jest not. Usually, they picked us up at the airport in a limousine. If you ask nicely and it’s a long trip across the country, they’ll often let you stay an extra day just for the trouble. Once you go back home and start actually enrolling patients, the CRO will spare no expense to make sure sites have all the supplies they need, etc. Supplies are usually sent by overnight FedEx. That has been my experience with pharmaceutical research costs. Have you never heard of all this? Who’s gonna tell? Dirty little well known secret. That’s why hard-on pills cost so much. Bunch of crap.