For a drug to come onto the market it must go through three phases of human trials before it comes onto the market. The drug then is continuously monitored once it comes onto the market with what is called phase IV trials or Post Marketing Surveillance Trial. If the drug is found to have adverse affects once it reaches phase IV it is then taken off the market. It seems logical right? If something is proven to have adverse affects on the population, those in charge (in this case the physicians) should not be allowed to continue its use. Why is this same approach not used in law making? Why are those in charge (in this case the politicians) allowed to continue to have a policy in place that is having adverse effects on the welfare of the public?
I am not going to talk about deciding what laws should and shouldn’t be passed initially, although I would hope they use the best interest of the public and available data to determine whether a law should be passed. I want to talk about how a phase IV trial should be applied to public policy. If a policy is proven to have a significant adverse effect on the welfare of the public then it should not have to pass through the same path as other policies to be removed from law. Let’s call this potential policy the “Phase IV loophole”. Now it would have to be up to the courts what constitutes adverse effects on the public welfare, but when it comes to health the same epidemiological approach as phase IV trails could be used to prove a policy should be reversed that has adverse effects on the health of the public.
A perfect usage for the phase IV loophole:
The current agriculture policy in the United States would definitely fall under the phase IV loophole. The number one preventable killer in the United States is obesity. Obesity is a significant risk factor for four out of the top ten causes of death (http://www.cdc.gov/nchs/fastats/lcod.htm) and with such a high prevalence (CDC prevalence data by state: http://www.cdc.gov/obesity/data/trends.html) it seems logical that the government should remove any laws that have been proven to be a significant contributor to this. The current agriculture policy is a significant contributor to this. The current policies that subsidise agriculture are not in line with the diet we should be eating to promote the best health:
There is a lot of history, economic and political reasons as to why this is the case, but there should be away to get around these things since this policy is literally killing us. We would not allow a drug to be on the market because Pfizer wanted it there if there were extreme dangers associated with it, this is essentially the same thing.
The phase IV loophole should be used for honest mistakes or outdated laws; things that are missed or overlooked when the law was initially drafted, however, more thought should be taken into the health and welfare of the public when passing new policies. Remember that there are three human trial phases before a drug is allowed onto the market. We should be just as diligent with passing laws. And on the flip side if there is ample scientific data support a policy that would improve the health and welfare of the public we should not keep it from them; you would not want the cure for cancer kept off the market because the lobbyists didn’t want it out there.
Dr. Elizabeth Pisani talks about rational policy making for HIV prevention in her TED talk here: http://www.ted.com/talks/lang/eng/elizabeth_pisani_sex_drugs_and_hiv_let_s_get_rational_1.html
Let’s make our laws reflect the data, our values and protect the welfare of all people.
I like this idea! I can think of many policies which would not pass the Phase IV test. Elizabeth Pisani (one of my former students in London, by the way!) makes a good case for needle exchange in the TED talk referred to above. It’s one of the most obvious changes we could have made to slow the HIV epidemic here in the US. But politics got in the way….
This is a such an interesting post! I have never really thought about it like this, but it is a great point. The fact that our government supports such a high agricultural output of milk and dairy makes absolutely no sense. It is disappointing to see that fruits and vegetables take up such a small part of our agricultural output. I hadn’t realized that the agriculture policy of our country neglects such vital food groups. You bring up a great point!