"Pharmaceutical Freedom"

For all our lives, there have been rules on how to bring a new medicine to the market: clinical trials, patient consent, double blind trials etc. But all this only started well into the 1900’s, “as drugs became more powerful, so did side effects”, wrote Thomas Hager in The Demon Under the Microscope. And for decades, the way trials were done was, well, horrifying:

“(Firms) often went to Africa to do large-scale human tests. In Britain they used soldiers. In the United States, tests were done on prisoners and inmates in mental institutions.”

But has the current system of checks and trials gone overboard, wonders Jessica Flannigan in her book, Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate. In a radio interview with Bob Zadek, she says we should have “freedom over our bodies”, same as the other freedoms we enjoy.

People handed the responsibility to the government to prevent a repetition with the “history of drug disasters”. That responsibility became a power with the government, a side effect of which is “the people who have been killed by the regulations”. Huh? Flannigan explains:

“They could have died waiting for drugs to be approved or because they lacked access to a prescription.”

Plus:

“The regulatory system prevents manufacturers from innovating and developing as many drugs because it raises the cost of drug development.”

Another issue she cites in the current system is the asymmetry of how the concept of “informed consent” works:

“The patient retains the right to refuse treatment… It would be illegal and morally impermissible to force somebody to accept treatment.”

Whereas:

“But a person who is terminally ill and wants to try drugs that they think are better than the standard of care is prohibited from doing so on the grounds that it could be too dangerous.”

It’s a topic where you can see merits in why the system is the way it is, and also the issues with it. Yet, don’t expect any changes, says Flannigan, because of the asymmetry of scenarios:

“(US medical regulatory agency) FDA is very sensitive to avoiding big public drug disasters that could make them look like they are not effectively doing their job. On the other hand, when people are dying because they lack access to drugs and people die of cancer because there is a cancer drug that is not yet available to them, people do not see that as a harm caused by the FDA, but rather a harm caused by cancer.”