Thursday, August 04, 2005

I Wanna New Drug

Is Big Pharma bad? Glenn Reynolds of fame defends them today at Slate. Click the title for link.

The pharmaceutical industry spends around $300 million dollars to get a new medication to market. You would think that every possible side effect and generally bad thing would be known by the end of this arduous process.

You would be wrong.

Human studies for medications must narrow the criteria in order to come to conclusions. For example, it helps if the subjects weigh the same, have the same gender, etc. to limit the variables. Most meds are never tested on children, in fact. It just doesn't sound good to have "experiments" go wrong on children.

"Off label" prescriptions get those meds into those needy little bodies. In essence, the children become walking freed-from-the-lab experiments. What will happen when we half an adult dose? We don't know. We'll find out soon though.

When my sons weighing a pound and 1/2 each were transferred to a well-respected Children's Hospital, the NICU chief physician just happened to be on call. His first order of business was to get my husband (I was at another hospital) to consent to the Hep B immunization. Which my husband refused.

Later, every doctor wanted us to immunize our kids. This finally shut them up: Produce one study, only one, demonstrating the safety of immunizations on a baby who weighs a pound, I said. There are none. The original vaccine studies were done on adults. And no studies have been done on multiple vaccines to show side-effects. Why? Because how would you know which part of the vaccine causes the problem?

Anyway, most drug studies are limited, is my point. If they waited for generations to see the true long-term effects, the pharmaceutical companies never make money and people who truly need the help of the drug would never get it.

So, what to do?

Here's a solution that's bound to irritate everyone: Make the trials less rigorous. If you have some nice rat studies and a case study or two, allow the medication to be prescribed in extreme cases: the end-stage cancer people, the diabetic who is getting his legs lopped off, the Parkinson's person who is immoble and she hates her life and wants it over, the kidney transplant person who is on his last legs, the child with progressive muscular dystrophy, the woman who has tried to kill herself fifteen times she's so depressed. You get the idea.

When these people have positive results, expand the prescriptions further. Maybe the cancer isn't end stage, maybe the diabetes is controlled, maybe the heart disease hasn't damaged the whole system, maybe the depressed person made a feeble first attempt at suicide but is miserable on her current drug cocktail.

Finally, if it works for those people, expand the medication to the moderately afflicted if the drug has miraculous tendancies. If the drug has too many side-effects but helps some of the worst sufferers, keep it around for limited use.

One caveat, if a woman is of child-bearing age (which in this insane world means between 12 and 50)--she is pre-menopausal, she should not be allowed to try these medications unless she will write a contract promising never to have children and if she does, and if there are gruesome side-effects, it is her problem.

People will die with this system. People die now. But how many potentially helpful drugs are out there but not used because the human studies are crazy expensive? Let the desperate try first. And don't withhold from them. Currently a person on death's door can't get an experimental drug if it is in the wrong phase. This is stupid. Most people want to die trying "everything". Let them.

Over 100,000 people die in hospitals, most because of human error with medication. This number doesn't count all the people who die at home (bleed out from coumidin) related to drugs.

Even beloved OTC meds like aspirin cause 10,000 deaths in American adults per year. Over 500 children die per year using aspirin. 70% of those taking aspirin bleed a little bit (less than a teaspoon, most of them) every day. My point? There are NO 100% safe medications. They all have risk, considerable risk when you look at the research closely.

HRT, Cox-2 inhibitors, now controversial research about a medical sacred cow: the pill causing long-term problems. They all have bad side effects. None are without risk.

Maybe we should label medications like this: You have a greater chance of dying from this medication than you have being struck by lightening, but less of a chance of being in a car accident. There are between 40 and 50,000 fatalities from car accidents per year. And it is the number one cause of death of people ages 6-27. People need to be able to put the risk in context.

So, for the cancer patient given 100% chance of death within three months, perhaps a medication that might cause the death in two months isn't so bad a risk. But then, maybe it will save him, too. Maybe it will give him an extra year. Maybe it will save his life and he lives to be 90.

Let the patient decide which risk he wants to take. I think we generally put too much stock into an FDA pronouncement that a medication is safe. We are all too laid-back about drug risks.

Free up the system. Let little drug companies innovate. Make it cheaper to get a drug to market. Remove the inherent bias toward deception, result-manipulation, etc. because the cost of getting so far down the road is astronomical. Remove the secrecy and information hoarding--bring competition to get the drug to the market fast. Help drugs be cheaper so everyone who wants to, can afford them.

Knowledge and freedom give power to the people. Link
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