I don't particularly like Strait's Times' Andy Ho's writing. They often tend to be over-jargonized, pretentious and generally confusing.
But this Saturday under the Daedalus column, he touched on a topic that has been somewhat troubling to me, that of the conduct of clinical trials by mega pharma companies.
Drug companies claim that the cost of developing a new drug ranges anywhere between US$0.5 -2 billion. (Other people have suggested that this is grossly inflated and that perhaps only about a fraction of 10% of this is actually spent on FDA required activities.) Although the patent life of a drug is 20 years, about half of this is taken up by research activities before licensing of the drug, hence most new drugs entering the market have only about 7-12 years of effective patent life during which to recover the cost of drug development.
There is therefore a mad rush by mega pharma companies to get their products to the FDA finish line. Not many make it. Last year (2008) only 24 made it through. To regulate this R&D process and to make sure that there is global acceptance of the data generated by these rushing mega pharma companies, the clinical trials are 'regulated' by a series of harmonized dos and don'ts called the Good Clinical Practice (GCP) guidelines. There is a global set that has been harmonized by the International Conference on Harmonization (ICH). Singapore has a set that had is based heavily on the ICH-GCP document.
These guideline do give some comfort that the human experimentation that occurs as a result of the need to do clinical trials is to a large extent highly regulated. Even in Singapore. In Singapore, the Health Product's Act covers all such activities and the Health Science Authorities is the delegated authoritiy that approves the conduct of all clincal drug trials. Every investigator that is involved in clinical trials need to be trained in GCP. Every institution/hospital involved in clinical trials needs to have an instituional review board (IRB) which will provide the ethical review for all protocols.
All this looks very nice and comforting. As usual in Singapore, when we want to tell the world we are 'world class' we make sure that we have all the bases covered. At least on paper, lah....
Let me tell you what I have been concerned about... (and I hope the Ministry of Health are listening here)
a] Despite the existence of IRBs in all the restructured hospitals, not all the IRBs function at the same level of professionalism and competence. This gets worse outside of the restructured hospitals. There is no mandated 'training' or certification of IRB members so we do not know how competent or committed IRB members are in reviewing the clinical trial protocols. Most are just 'arrowed' to do the work, without any proper recognition of work done. To make matters worse, none of the IRBs are ever audited to make sure the processes are as intact as people assume they are.
b] Investigators(consultants,professors etc) are supposed to undergo training and be competent in GCP. But the only institutional expectation at both SingHealth and NHG clusters are only for them to be certified through a nominal online certification programme run by the Collaborative Institutional Training Initiative (CITI) (this one, anybody can pass...!!).
c] The IRBs never ever audit the clinical trials done in the hospital unless some shit hits the fan.
d] The HSA never ever audits any institution to see if they have the processes in place, and if they are actually compliant with whatever they say they are doing. I think basically HSA would rather not know.
e] The clinical trial units that do human experimentation are never audited, and there is no mandated certification of the facilities, so we can only assume that these units can handle emergencies and and manage the subjects if anything goes awry.
So do I have much faith in the environment that has been set up in Singapore so that we can play in the big league? Sadly, no. That we have not had a major incident here is probably more due to good fortune, than any good organization.
So do the investigators do what they say they are doing? Who knows? Does anyone really know what is happening? I have my doubts.
5 years ago