One of our national pimples is coming to a head, and it’s pitting those that understand medicine against those that don’t. The former group understands that there’s never a free lunch; that you don’t get something for nothing; that everything in medicine is a trade-off between risks and benefits. The latter group expects a perfect pill for every disease (or even just a pill for every disease).

An attending that I’ve really come to respect over the past weeks made a similar comment out of the frustration with Mexican immigrant family. The boy in the family wasn’t taking his anti-seizure medication regularly (which is important, both because it prevents seizures, which can be dangerous to the patient, and because it’s dangerous to quit an anti-seizure medication cold turkey). My attending, himself an immigrant, said “there was a cultural problem,” but I now think I see what he means.

Until we develop the perfect pills and vaccines and surgeries without any risks, side effects, or complications, everyone must understand this simple fact: everything in medicine is a trade-off between risks and benefits . We do our best to minimize these risks and maximize these benefits as physicians–by doing research to discover which drugs work better and which operations are safer, but even we cannot prognosticate. Leave that to the groundhogs . We can tell you with X percent certainty that a drug will work, or that Y percent of patients will have an infection after surgery, but right now, we don’t know which people are which, in most cases.

That’s the tough part about medicine: we do all this research and publish all this crap to do our best to predict the future; we’re the ultimate in control freaks. We want a good outcome for our patients, so we study and crunch numbers to try to have more control over the outcome, but nothing’s for certain. Life’s precious and fragile. We’re doctors, not miracle workers.

Now, this is no blame-free mantra. As physicians, we must make sure patients understand the above simple fact. But we must also provide them with as much information as possible, in as easy to understand format as possible. And, as we have learned from the Vioxx disaster, we must not allow any possible risks that are known to be hidden. I’ve spoken with several patients in chronic pain with stomach problems (the only group Vioxx should have been targeting) who say that they’re very upset Vioxx was taken off the market: it was the only drug that helped them. They said they were willing to take the risks of Vioxx; it should be each person’s choice.

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Really disturbing piece on Merck’s promoting of Vioxx , downplaying the heart risks. A shame. I used to think Merck was one of the more ethical of the drug companies.

A drug’s ability to prevent or cure or slow the progress of disease should stand on its own, not on $2,000 sales bonuses. [via DB’s MedRants ]

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Osteoporosis is a common disease of bone wasting, predominantly in older, post-menopausal women. It’s an important disease mostly because it predisposes people to bone fractures (hip, femur) after falls, and breaking a bone late in life is correlated with poor recovery outcomes and morbidity.

So we’ve got Fosamax (alendronate) that many people take to prevent bone loss, but it turns out to be a pretty caustic molecule. So caustic, in fact, that you have to take it standing up , and stay upright for an hour after you took it, without food, and with a big glass of water. “After swallowing the tablet, do not lie down, remain fully upright sitting, standing or walking, for at least 30 minutes and until after you have eaten.”

If we can prescribe behaviors associated with prescriptions, I’ve got an idea for an excellent new blood pressure medication: a sugar pill that must be taken along with an hour of playing with a pet . I’m going to make millions.

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One of the leading Eli Lily researchers on PTH spoke to us yesterday about PTH and its actions. A good lecturer, but raised a couple thoughts in my mind:

• Should companies be able to patent drugs (hormones) we make naturally in our own bodies? Sell it, fine, but patent it?
• After he talked about the wonders of PTH (and glossed over calcitonin), I would’ve appreciated it if he had told me that it’s been found to cause osteosarcoma in rats . While there’s no indication that it causes bone cancer in humans, it seems a little suspect that we had to learn the fact from our pharmacology lecture today.

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In an article about the FDA and its internal conflicts, a Stanford professor is quoted as saying he was threatened by a Merck veep that if he spoke out about Vioxx, his academic career could become much more difficult:

Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx.

Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: “I was warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had extensive contacts within academia and could make life very difficult for me at Stanford and outside.”

Now, here’s my question: who’s the doc at Stanford that Sherwood thought would be willing to damage Singh’s career?

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The Wall Street Journal is reporting that emails from the 1990s show that Merck was already concerned about Vioxx’s cardiac risks back then. What a shame. I usually think of Merck as being a little more ethical than the other drug companies. Guess I was wrong.

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Peter Rost has an excellent Op-Ed in the NYT:

I have a confession to make. I am a drug company executive who believes we should legalize the reimportation of prescription drugs. I know that I have a different opinion from that of my employer on this matter, but to me, importation of drugs is about much more than money; it is about saving American lives.
According to a study by the Kaiser Family Foundation issued in 2000, 15 percent of uninsured children went without prescription medication in the previous year because of cost, 28 percent of uninsured adults went without prescription medication because of cost, and 87 percent of uninsured people with serious health problems reported trouble obtaining needed medication. We have 67 million Americans without insurance for drugs, according to the foundation. They pay cash – full price – and can’t always afford life-saving drugs. American drug prices are about 70 percent higher than in Canada and almost twice as high as in Europe…
Every day Americans die because they can’t afford life-saving drugs. Every day Americans die because Congress wants to protect the profits of giant drug corporations, half of the top 10 of which are French, British and Swiss conglomerates.
I have another confession to make. Americans are dying without the appropriate drugs because my industry and Congress are more concerned about protecting astronomical profits for conglomerates than they are about protecting the health of Americans.

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Sometimes even the AMA gets it right :

Dr. Andrew F. Calman of San Francisco, an ophthalmologist who pushed for the new policy adopted by the medical association, said: “I don’t think it’s a Democratic or a Republican issue. We have the support of doctors from different points on the political spectrum. We’re very concerned about patients’ access to affordable drugs. I have some glaucoma patients who need to take three or four different types of eye drops to avoid going blind, and each medication may cost $50 to $100 a month.”

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An update on the Peter Rost story : Pfizer sent a team of lawyers to grill him on his political activities and who he’s talked with . Not only is it scary to see a company investigate someone for their private political beliefs, it shows everyone just how scared Big Pharma is of reimportation.

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African sleeping sickness is, pretty much, deadly. You get bit by a tsetse fly , you get a protozoa inside you, and if left untreated, you die. Eflornithine was discovered in the 1990’s–it’s nicknamed “the resurrection drug” for its ability to basically cure comatose people infected with African sleeping sickness. When the disease gets really bad, it enters your brain and spinal cord; eflornithine can also enter the brain and spinal cord however, and kill the protozoa making the patient sick. The other major treatment for severe sleeping sickness is called melarsoprol , but it’s much more toxic and much more dangerous; it carries with it a 4-12% risk of killing the patient.

So we’ve got a pretty good drug for treating this serious, fatal disease, and it has few side effects (sore throat). However, it’s surprisingly expensive to make, and since the countries with sleeping sickness are primarily poor, developing nations, drug manufacturers stopped making the drug. No big deal. Sleeping sickness only affects 500,000 people annually. Hi, sarcasm.

In 2001, Aventis, the patent-holder, donated $12.5 million to provide 60,000 doses , and an oral form of the drug is being developed.

Lucky for those dying Africans, eflornithine has a new market: slowing the growth of unwanted facial hair. Personally, I find it disgusting that we went 6 years without a better drug with less side effects (and mortalities) because it wasn’t profitable ($12.5m is pennies for Aventis). But I find it absolutely disgraceful that the unwanted facial hair drug, Vaniqa, advertises using what appears to be a tsetse fly on a woman’s face , as well as other bugs. The quote on the homepage sums it up nicely:

bq. What a burden that has been lifted from my life! I feel so free now to be who I really am. I’m not at all self-conscious with people.

Is this how far we’ve come? The burden of facial hair is more important to us than totally preventable deaths in Africa? We have the means, but not the will to do it.

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