A woman takes her four month old baby to her local general practitioner for a severe rash he has developed on his chest. The doctor prescribes a cream that is suitable for a young infant, under Australian prescribing guidelines.

Once at home, the mother goes online to both Australian and American government websites to check the product information guide since it was not given with the cream. She finds out that the product is not recommended for use in the United States of America for infants under the age of two. This recommendation is based on the manufacturer’s own admissions that some patients have reported developing skin cancer and lymphoma after using the product. Further long term studies are required to confirm this relationship. The cream is permissible under Australian prescribing guidelines.

The mother discontinues use of the cream immediately because of a family history of skin cancer and prints out the information to take to the doctor at her next visit. The doctor advises that he was not aware of this possible adverse effect of this cream.

Should the doctor prescribe this cream to the next infant under two he sees with this condition?

We’d welcome your views on these and related medical ethics themes in Professor Stephen Leader’s recent Living Ethics Winter 2011 article Professional Power http://www.ethics.org.au/living-ethics/ ... onal-power

Hi.

I believe not, if there is a material concern about the safety I would say he should stop perscribeing the medication untill further infomation is sourt by him.

Should he contact the various Australian pharmacutical orginisations / regulatory body citeing this problem and it is cleared through standard scientific testing to be safe then it is good to go again.

The major issue I have is safety for the patient. Effective theraputic medications is important, but not at the risk of serious side effect.

The second issue is what does our government say, what are the material risks for the child, is the side effect better then the illness being treated? While he should stop untill further advice technical, legal and pharmacotropic should be gained, if clear I would assess it then on a patient by patient basis on the basis of safety and benifit to the patient.

And before I post, my appoligies for the spelling.

"Should the doctor prescribe this cream to the next infant under two he sees with this condition? "

NO. But he probably will if they are paying him in Fringe Benefits for prescribing it.
Ethically he should be reporting it to the proper authorities.

Unfortunately medicines are not the only things that should be banned and even though many additives are banned in some countries they are not banned in others.

The manufacturers are known for continuing the use in Third World Countries of many downright dangerous medicines banned in their own country.

In my view it is time for the manufacturers of to be policed. Same as polluters etc.

>>Should the doctor prescribe this cream to the next infant under two he sees with this condition?

I have to say that I find this hypothetical dilemma to be too preposterous to take seriously. Is it based on any real event?

We have a body in Australia called the Therapeutic Goods Administration. Before authorising any medication for use, the TGA looks at all the available evidence. This would consist of clinical trials and adverse event reports. (The USA has a similar body, the Food and Drug Adminstration.) If there were any plausible evidence that the medication were associated with the serious adverse events you describe, it would not be authorised for use in the country.

In the situation you describe, the correct course of action for the doctor would be to address his concerns to the TGA and await their response.

The TGA exists because it would simply not be feasible for each prescriber to conduct his own research.

For the most part, TGA recommendations are in accordance with those of the FDA and the European bodies. If anything, the TGA tends to be a little more conservative.

It seems there’s a risk to prescribing the cream.

On the other hand, there’s a risk to not prescribing the cream, if a painful rash goes untreated, or is treated with something less effective. The baby will continue to suffer. The condition may exacerbate. The baby’s immune system may be compromised. And so forth.

It’s a question of balancing these two risks, which is not an easy balance to strike. The downside risk of prescribing the treatment - skin cancer, lymphoma - seems severe, but the risk of actually developing these conditions may be vanishingly small. And it may indeed be that it’s not clear that the babies who developed these conditions did so because of the cream. The downside risk of not prescribing the cream seems less severe, but it may be much more likely to eventuate.

I wouldn’t assume that the Australian regulatory approval was given in ignorance of the perceived downside risk. (In fact, that’s probably unlikely.) More probably, the Australian regulator may have simply found a different balance of risks from the Australian regulator. Have we any reason to suppose that the American regulator is better at balancing risks than the Australia regulator?

As muskrat points out, unless every doctor is going to conduct his own clinical trials, the question he faces is not “is this treatment safe?” but “can I rely on the regulator’s assessment that this treatment is safe?”. And, if he has competing assessments from different regulators, the question is “which regulator’s assessment should I prefer?”.

I believe not, if there is a material concern about the safety

This dilemma was based on a real event.

He should discontinue prescription, and seek more information about the drug, as well as contact regulating bodies in his region/in Australia.

He should also critically review the literature/studies done on the carcinogenicity of the drug. Perhaps contact the researchers who conducted the study, and get their advice.

Meanwhile, he should seek alternatives. If there are no alternatives, he should prescribe the drug depending on how severe/serious the rash is and how severe the consequences of leaving it untreated for a short period of time would be.

This all seems like a lot, but when lives on the line, no amount of caution is excessive.