Posted on 07/23/2002 3:54:10 PM PDT by anymouse
Doctors are giving infants and babies the anti-impotence drug Viagra to save them from a life-threatening lung condition even though it has not been tested on children, a magazine said Tuesday.
The drug, produced by U.S. pharmaceutical giant Pfizer, has already been used to treat a small number of children with pulmonary hypertension (PHT) in India, the United States, Canada and Britain with promising results.
"Critics have expressed serious concern at the fact that no clinical trials have taken place for this use of the drug and at the wide variation in doses used," New Scientist magazine said in its online version.
Although the drug is approved for the treatment of impotence, doctors have found that it helps babies suffering from PHT, which affects 28,000 children and 250,000 adults in the United States alone.
The magazine said adults with PHT were already being enrolled in clinical trials of the drug. Studies on children could start in the next few months.
A spokesman for Pfizer said the company was considering using the drug to treat PHT, but could not comment on any clinical trails.
"We are seriously looking into the use of Viagra for PHT," he told Reuters.
Viagra was originally developed to treat angina by opening up blood vessels when doctors and patients discovered the impact it had on male sexual arousal.
PHT is a blood vessel disorder of the lung. In babies with the problem a bypass vessel used for fetal circulation fails to close after birth, depriving the child of oxygen.
Babies with PHT are usually put on a ventilator and given nitric oxide, but doctors who have used Viagra for PHT said it works better than nitric oxide and has fewer side-effects.
"At the moment it is given on a compassionate use basis agreed with the hospital's ethics board," said Ian Adatia, of Toronto's Hospital for Sick Children.
Adatia has given the drug to 10 children. Dr. PK Rajiv, of the Amrita Institute of Medical Sciences in Kochi, India, treated an eight-hour-old baby girl with the drug after other treatment failed.
"The child recovered in 48 hours and within a week two other newborns survived the same treatment," he told the magazine.
The use of Viagra in babies highlights the problem of giving drugs approved for adults to children. Very few drugs are tested on babies and children because it is not cost-effective for the pharmaceutical companies and parents are often reluctant to put their children in clinical trials for an untested treatment.
Children may also react to drugs differently from adults. Determining the correct dosage for a baby could also be difficult and infants could be more susceptible to toxic effects because of underdeveloped kidneys and livers.
OTOH, these drug companies are out of control. Just like my attempt not to comment ... =)
I agree. On this I am a libertarian. I would rather that my physician, in consultation with my family, be free to use whatever drugs (excluding those illegal due to abuse) he sees as best.
There also is a scandal in drugs being taken off the market by the FDA because some patients died from them, even though they are needed by certain other patients to live. My wife's father, an intelligent man, has been having trouble with diabetes control since a drug he used to take was removed from the market. Why shouldn't he and his doctor be free to judge the risks and benefits themselves?
It also highlights the fact that lack of FDA approval doesn't prove that a therapy does not work--and that"Desperate ills are by desperate measures cured, or not at all."And that throws the liberal "zero risk" conceit into a cocked hat.
I am glad to see here the idea the "zero risk" is a liberal concept, since I some other threads I had seen FR'ers taking when seemed to me extremely risk-adverse positions. Although medicine should be "evidence based" as much as possible, a doctor could not stay in business if he only did what was exhaustively proven.
How about this one? People are not willing to be, to some extent, experimental subjects, hardly deserve to benefit from the sacrifices of past human experimental subjects.
The same thing occurs in psychiatry, except there I've been told they're a good TWENTY years ahead of their treatments being "officially approved" by any self-appointed medical standards organization or the FDA. (The key, though, is make sure your psychiatrist is a psychopharmacologist. That means they're infinitely more versed in the pros and cons of each medication or mixture of medications, and keep up with every major new development that anybody reports anywhere. Your run-of-the-mill shrink or psychologist will generally just pick one of the big-name drugs at random and see if it works for you, and just keep bouncing you from drug to drug until one of them shows an effect. Or, worse, they may just prescribe for you whatever they have a ton of samples of in their closet.
Generally, such drugs continue to be marketed overseas, and I'm pretty sure it's legal for you to import any non-FDA-approved medication from another country as long as you're only ordering enough for your own use.
that throws the liberal "zero risk" conceit into a cocked hat
I'm glad to see here the idea that "zero risk" is a liberal concept. Although medicine should be evidence-based as much as possible, a doctor could not stay in business if he only said and did what was exhaustively proven to work.
How about this one? People unwilling to be, to some extent, experimental subjects, hardly deserve to benefit from the sacrifices of past human experimental subjects.
Thank you for the idea. However, my father-in-law, like me, would not act behind my physicians' backs. I know that it is common for patients to take drugs without telling their doctor, but it certainly is a bad business.
The thalidomide babies were not American. U.S. drug approval procedures were already then sufficient to protect us from this, and yet have become far more stringent over time.
To make a long story short, the thalidomide situation with morning sickness was unique. We now know that pregnant women with non-serious illnesses should not be very early adopters of new drugs which block formation of blood vessels. Overly broad lessons have been drawn from that tradegy.
American Conservatism conserves the American tradition of freedom to innovate--not the status quo. What is "zero risk" but the conceit of absolute protection in the herd?People unwilling to be, to some extent, experimental subjects, hardly deserve to benefit from the sacrifices of past human experimental subjects.
They are also pretty weird, in that there's no such thing as ultimate physical safety in this life--eventually we'll all reach the "desperate ill" stage.Those who think the status quo is safety, must think that there is a cure for Alzheimer's Disease. There isn't, you know--and it's far too common in octagenarians to merit complacency.
Yes. It is also good for a form of leprosy. And yet it was illegal in the U.S. until recently, on the ridiculous theory that it might be accidentally prescribed to a pregnant woman in face of all the publicity about the tragic side effect. In fact, ever since the thalidomide tragedy was decisively publicized, there have been zero additional thalidomide babies, even though some countries, including Israel, never took it off the market but rather trusted the good sense of their nation's physicians. Here is a good link:
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