They are taking my drug without being in a clinical trial

[Th1onein]

I don't know if you guys remember or not, but I published a paper on cystic fibrosis and put forward a new model of the disease, which called for a therapy involving the oral ingestion of a drug which comes from plant seeds. Some people have managed to get that compound from a chemical company and are taking it.

One of them wrote to me, with a diary, of the effects of the compound. There were no obvious negative side effects of the compound, in fact, the person was experiencing some positive effects, but there is no lab work to support this, and it might just be the placebo effect.

What would you do?

[HaggardsMethDealer]

1. It's not your drug, is it?

You aren't really liable. Is that what you are concerned about? Just have to let that person know that the drugs safety and efficacy has not been proven.

[Th1onein]

4. I'm concerned that they will get sick from the drug.

n/t

[Sweet Freedom]

5. You must respond

If you are aware of any potential danger, you must let them know. What if the patient experiences an adverse event? And then there is a record that you were informed prior to the event? I would recommend writing a letter warning the person of any potential danger and insisting that they take this treatment only under the care of a physician. Have your lawyer review it and send it on.

[orpupilofnature57]

2. Go Forth! ,Phen Phen ,thalidomide ,and a dozen others all had " Clinical Trials"

You sound like a reasonable person as opposed to a money grubbing Ph armer ,I'm sure you discussed the lack of history of the therapy ,part of a Democracy is exploring, good luck.

[HaggardsMethDealer]

3. Actually thalidomide didn't.

The makers of thalidomide did not do clinical trials and simply lied about it. That entire debacle basically created the FDA and the rules we have today.