A few years ago a lady of my acquaintance, the wife of a colleague, suffered terribly from arthritis. The only thing that was effective at relieving her pain was a product called Vioxx.
Then a study was done wherein it was determined that long-term use of Vioxx doubled one’s risk of suffering a heart attack or stroke. My friend, in her early 80s, heard about this when there appeared on television — yes, faster than news reports could bring it to her — an advertisement seeking clients in a lawsuit against Merck, the makers of Vioxx.
Vioxx was immediately withdrawn from the market. My colleague’s wife, who would gladly have endured the possibility that her heart attack risk might go from not at all likely to twice not at all likely, was not given a choice.
“What is ‘long-term’ when you’re in your 80s?” she asked.
She lived the rest of her days in increasing, debilitating pain. There was no way for her to stipulate that she was aware of the purported risks and wished to have the drug anyway.
There ought to have been such a mechanism, but there wasn’t, and isn’t. Patients are not allowed to make their own choices.
The usual testing of therapeutical products goes something like this: once a product is developed it is initially tested on mice, then rabbits, then monkeys, then lawyers, then human beings. If it cures all the warm-blooded subjects — sorry, lawyers — it’s deemed fit for use. (This was going to be the subject of a meeting of the Bar Association of Hell, but they couldn’t find a space big enough for everyone.)
It takes time. People do not always have time.
We often read of wonderful new therapies which too often then disappear without ever having been heard of again. Just the other week there were reports of a promising new study of a single drug that manages a wide range of human tumors. (Much cancer research now is toward the idea that rather than curing it, it might be “managed” in the way that diabetes, asthma, and AIDS are, allowing for a good and relatively long life for victims of the diseases.) The new drug was effective in mice. Will we ever hear of it again? Who knows.
You might be surprised at the number of perfectly useful pharmaceutical products that never make it to market for one reason or the other. (One reason is the threat of lawsuits; the other is the U.S. Food and Drug Administration.) It would — in fact, did — take a whole chapter of a book to describe the sorry tale of Dr. Michael Zasloff and the broad-spectrum antibiotics he discovered, which he named “magainins.”
Do a web search on his name or on “magainins” if you’d like to dig for the details. It is enough here to say that while head of genetics at the National Institutes of Health, Zasloff discovered a tremendously powerful naturally occurring antibiotic that had no adverse side effects, was cheap to produce, would not be subject to microbes developing resistance to it, and would have cured many previously untreatable illnesses at little or no risk to anyone — and the reason you’ve never heard of it is that the FDA killed it. (We might note that even penicillin languished in the laboratory until a world war produced a desperate need for a powerful antibiotic. How many lives might have been saved had it gone into production sooner?)
The scientific and government regimen for testing new drugs is, alas, a fairly leisurely one, if you’re someone who will die if you do not have access to those drugs. Once they have been proved safe and effective, which takes years, they then have to make it past the FDA, which may or may not be corrupt but which certainly acts as if it is, and then the lawyers.
There ought, though, to be a way for desperate patients to say, “hey, I’m willing to take a chance. This stuff looks promising, and my outlook isn’t promising. Jump over the monkeys and the FDA and give me some. I’ll take the risk.” No, it would not be part of a carefully selected scientific study (which is not to say that the outcome would be of no scientific value). But people ought to have that option. Even vague, faint, unrealistic hope trumps no hope at all, as witness the number of people who buy lottery tickets.
People do not have that option. Nor would any researcher smart enough to produce a drug worth taking dare allow it, under the current scheme.
So sick, desperate people sell their houses and go to some strange, distant place where they are infused with extracts from local holy mud or something, instead of having access to unapproved therapies here that might actually work. Often stuff that is approved here does not reliably cure or even slow anything.
My acquaintance should have been allowed to have her Vioxx; her life, her choice. Others should be allowed to risk their lives in an informed hope of saving them.
The current way is elaborate and systematic. It’s just not designed to bring good medicine to real people.
Dennis E. Powell is crackpot-at-large to Open for Business. Powell was an award-winning reporter in New York and elsewhere before moving to Ohio and becoming a full-time crackpot. You can reach him at dep@drippingwithirony.com.