Saturday, July 31, 2010

How to Deal With Drug Companies

There are a lot of drugs out there and corrupt people who want to sell them for a profit, even if it harms the customer. Here are a couple of modest ideas on how we should deal with that problem.

Plan #1

Attitude:

Corporations are the enemy. They exist to make money, and have an insidious tendency to direct groupthink towards maximizing profits, even among otherwise normal people. Unfortunately, there are a lot of sick people out there who need effective treatments, and corporate greed can be a very effective motivation to put all the resources needed for mass production of those treatments together. On the whole, corporations are a necessary evil until someone can devise a better means of safely producing and testing drugs.

Culture:

Encourage scientific and critical thought. Require that evidence be easily available for review and critique. Encourage openness and international cooperation between parties of different backgrounds and motivation.

Don't trust anyone at their word alone. Don't trust in "common knowledge" or that gutter known as mainstream media, which has a habit of laying off or ignoring their science reporting division. Don't trust chain emails.

Corporations must be held in check by watchdogs, not just in the government, but by scientists, doctors, and other concerned individuals from multiple backgrounds.

Regulation:

In the past, caveat emptor capitalism led to shoddy production. Because people's lives are at stake, there is little room to allow for error. We must assume that corporations will cut corners wherever they can, and that will include safety testing. Given the placebo effect, corporations will be heavily tempted to cut corners on efficacy testing as well. As such, we must form an institution that will watchdog the corporations and force them to undergo a rigorous program to prove their products are both safe and effective. It would probably go something like this:

Step 1: Cell culture: This phase is mostly so the company can find promising treatments without involving a risk to a living being.

Step 2: Animal testing: Just because something works in a petri dish doesn't mean that it'll work within the context of a whole living animal. Living things are complex entities, full of conflicting forces. All too many medical claims that float around by word of mouth are based solely on preliminary studies that never involved an entire organism.

Step 3: Human trials: Because this is the most important and risky part of drug testing, it is divided into its own phases. It's especially important to be rigorous in controlling and blinding these experiments because human bias, coincidence, and the placebo effect can easily alter the results of a shoddy experiment.

Phase I: Safety trials: Experiments done specifically for the purpose of finding out if the human body can tolerate the drug in question. Animal trials aren't perfect, which means there could be unforeseen consequences in the human body.

Phase II & III: Efficacy testing: Trials done with a smaller and then a larger group. Without these trials, the patent medicine era of alcohol-induced placebo effects could easily return. The drug in question must prove more effective than a placebo.

Step 4: Approval: Only after a drug has passed all of these trials can a corporation be allowed to sell the drug.

Step 5: Post-market research: Reality has a way of throwing unexpected turns at humanity. It's quite possible there may be dangerous interactions with other drugs that were missed in earlier tests, unexpected dangers for people with certain conditions, a side effect that simply didn't show strongly in the test groups, or any other tragic surprises. If these are detected in the wider population, the drug may be subjected to recalls mandated by the regulatory body. Without this regulation, corporate bean counters could easily just market the drug willy-nilly and accept the loss of a few customers.

Plan #2: The Alternative Solution

Attitude:

Draw an imaginary line. Call one side "alternative" and the other side "conventional." The corporations on the "alternative" side are perfect angels, incapable of making a mistake or having a dishonest or greedy intention. The corporations on the "conventional" side are pure evil and just want to do stuff like poison babies for no reason whatsoever. Because, you know, that's how it is in the movies.

Culture:

Allow the "alternative" corporations to manufacture a culture predisposed to blindly trusting them. The imaginary line must be enforced as an absolute tenet of faith, because the "alternative" corporations rely on being granted special privileges to help them compete. Encourage people to be dismissive of safety and efficacy trials as a waste of time because treating people with blind shots in the dark is much more important work than being informed or understanding the problem.

Encourage doublethink. For example, nearly every member of the de facto "alternative" cartel says they have the one true solution to every health problem, but if it doesn't work for the customer, tell them that everyone reacts differently to absolutely everything and that they should shop around among other members of the "alternative" group and subjecting themselves to shoddy experimentation.

Encourage customers to think that they are infallible gods, incapable of mistaking placebo effects for genuine benefit. Encourage parents to think that simply producing a child makes them immune to human weaknesses of perception and memory.

Regulation:

Bog down the "conventional" corporations by making them go through all those regulatory hurdles in plan 1 and still doubt their results by pretending they're secretly in control of the regulatory body of this nation, as well as all the universities involved in the research. Pretend that there are no other nations out there to test the drugs, or that their analogous regulatory bodies are also in on the conspiracy, despite the untenability of massive conspiracies. Because we all know that, as Hollywood keeps telling us in its action thrillers, worldwide conspiracies of thousands of people are really easy to pull off.

Get a bunch of lobbyists to make an exception for some of the "alternative" drugs by calling them "supplements" instead of drugs and make them nearly immune to regulation. Because we all know perfect angels don't need to do rigorous safety and efficacy tests and can just be taken at their word. They need all the profits help they can get against the evil "conventional" corporations. Because they never make mistakes, this means that they can market their products directly without any study and let their guinea pigs customers experiment on themselves and their children.

Encourage parents to think of their children as their property, so that they can justify trying anything on their sick child under any circumstances, especially if there's no reporting or control group.


I don't know about you, but I'm leaning towards plan #1.

Saturday, July 17, 2010

Doggerel #219: "I Did My Own Research!"

Welcome back to "Doggerel," where I ramble on about words and phrases that are misused, abused, or just plain meaningless.

The information age allows people incredible access to scientific data and exchange of information. Unfortunately, it also allows incredible access to urban legends and crazed rants that would normally be relegated to badly copied manifestos handed out on the street.

What separates real research from from what the typical woo does is discrimination: You have to know what forms of evidence are more reliable than others. A double-blind control study is superior to a case study, which is superior to an anecdote. A video recording is superior to human memory. Quality also matters more than quantity, most of the time. A thousand eyewitnesses are less objective than a handful of cameras.

Woo "research" typically involves collecting anecdotes, a form of cherry-picking. In alternative medicine, for example, positive outcomes for an alleged remedy are popularized, but, because of the culture, negative outcomes are generally ignored, usually leading to the patient to quietly change remedies. The result is a large collection of isolated positive anecdotes divorced from the larger context of the world.

Real research has to look at large numbers. With small groups, and worse, individual test subjects, there is little ability to rule out coincidences. Scientific studies require large numbers of subjects or trials because large numbers make coincidence less likely of an explanation. Most people simply have trouble thinking about the large numbers involved in the world, and how millions of people experiencing the world over many years can produce all sorts of "unlikely" events. We use the scientific method because of such shortcomings in our thinking.

Another form of false research comes in the form of blindly trusting people with fancy degrees or even Nobel Prizes. Being a scientist, earning a degree, or being awarded a prestigious prize is not a certification of papal infallibility. Scientists are people. People can make mistakes. Working in a manner that minimizes the chance of mistakes is what makes your conclusions more likely to be accurate. It doesn't matter who you are. High quality work is high quality work. Knowing how to distinguish real science from anecdote and hearsay is what separates a researcher from just another student of Google University.