Placebos break taboo in cancer drug tests

[wdlove]

Study seeks hope for desperately ill


By Raja Mishra, Globe Staff *|* July 4, 2004


For 10 years, drugs and surgeries kept Betty Rosenbluth alive, but the cancer in her gut persisted and soon the 73-year-old woman could scarcely make her beloved Sunday stroll up the road to Mt. Zion Lutheran Church.

As a last resort, she journeyed from her home in York, Pa., to the Dana-Farber Cancer Institute here to participate in a medical experiment on a cutting-edge cancer drug that has pushed the envelope of research ethics.

As part of the experiment, her doctors explained that she could get an inactive pill called a placebo. They said giving a placebo at random to some of the patients, who all were dying, was the only foolproof method for showing that the drug worked and thereby convincing the federal government to approve its use for many thousands of desperate patients.

The ongoing experiment and a few other clinical trials of cancer drugs are breaking what had been a taboo in cancer medicine: Denying dying patients promising though unproven drugs that may prolong their lives.

http://www.boston.com/news/nation/articles/2004/07/04/placebos_break_taboo_in_cancer_drug_tests/

 

[jsw]

While I understand and agree with the need for placebo-based studies in most cases to verify the efficacy of a treatment, it would seem to me that denying dying patients an opportunity for a drug that might help them is unethical. They will die without the drug. They might die with the drug. If they die faster, it might only be by a matter of days. If they live longer, it might be by a matter of years.

For the terminally ill, I see no ethical reason to deny treatment. Surely, if enough get it, knowing in advance the previous statistical survival rate of the disease, one could show compelling argument for the usefulness of the drug by showing improved survival rates.

 

[wdlove]

I agree jsw, it's a very tough situation in running clinical trials. A real catch 22. The only real way to test drugs properly for efficacy is with double blind studies. In the case of cancer patients it is even more acute. They are usually willing to try anything. For FDA approval this kind of testing is a requirement. As has happened in the past if efficacy of a drug is determined early then the clinical trial is ended and all would receive the treatment. At any point the patient can withdraw from the study. Patients that are not the a study can only receive approved cancer treatments. Like anything else it has to be looked at as being beneficence and doing for others.

 

[Makosuke]

I was under the impression that in these studies the "placebo" is usually the best traditional treatment, not absolutely nothing. That is, you either get standard treatment or the experimental treatment, though they don't tell you which. Then, if the experimental one is more effective than the traditional one, it's worth while. If it's worse, then it's not as effective a treatment.

The placebo effect doesn't enter into it either way, since the person doesn't know whether they're getting a new treatment or not, so any belief in the effectiveness of the medicine that makes it look better than it is works equally well on the traditional treatment. And, nobody goes untreated.


...of course, since a sugar pill can cure incurable cancer thanks to the placebo effect in a few cases, even nothing can be effective treatment if the patient both believes it and is lucky.

 

[caveman_uk]

A placebo is a tablet (or other delivery method) that to all intents and purposes looks identical to the 'real' drug under test. Nearly always the doctor giving the patient the tablet doesn't know if it's real or not either. The test is therefore a 'double-blind placebo' - so that the doctor can't influence the test. The tablets/patients are identified by number and the contents of the tablets with each number are only known to people doing the stats.

Quite often in these trails it can be so obvious that the treatment is working that the trials are ended early and everyone goes onto the real treatment.

If you imagine it's difficult doing trials on the terminally ill imagine the ethical problems of doing drug trails on children or neo-nates. Sadly these problems mean that the majority of drugs that are used on children have only been tested on adults and are used by doctors off-label.

 

[wdlove]

It is a difficult situation for both the doctor and patient. This is where the art of medicine is useful. Usually the patients that enter into these clinical trials have already used all the standard treatments without success. They are really looking for a last resort.