PsychoTropicalResearch, serotonin and serotonin syndrome research.
New Drug approval
New Drug approval
Date Created: 05/10/2000 Last Modified: 05/10/2000 Last Checked: 02/05/2002
My notes on various new antidepressants sometimes highlight the relatively limited scientific evidence concerning their effectiveness, this applies especially to longer term use and use in groups of patients other than the highly selected group on which the drug was trialed for the purposes of approval by regulatory authorities.
The mechanisms by which drugs are approved in western countries are so fundamental that one tends to forget about them. They are generally hidden from the everyday attention of practicing doctors.
It is therefore salutary for prescribing doctors to remind themselves of the nature and limitations of the processes involved in regulatory approval.
Money is ever-present and overpoweringly influential in the equation. The potential earnings from drugs are beyond the everyday experience and comprehension of many of us. Figures quoted for the maximum annual earnings of Prozac when it was at its most popular (it is probably declining now) were that it peaked at $1000 million US$ in the American continent annually. Some of the benzodiazepines probably have annual sales around the $250-$500 million pa mark. Such figures eclipse the gross national product of some smaller countries.
That such sums of money have a subtle but profound influence on all of the regulatory processes involved in drug approval must be considered as a real possibility. Indeed there are examples that suggest such influences can be negative to an extent which requires consideration and comment.
Documents 'revealed' as a result of a court case involving a drug manufacturer revealed a memo from a senior medical member of the company which used the following phraseology when commenting on the way in which information (unfavorable to their drug) was being handled and presented by the company.
He wrote "I do not think I could explain to the ... [a regulatory authority], to a judge, to a reporter or even to my family why we would do this, especially on the sensitive issue of suicide and suicide ideation."
The very fact that a senior person within a company felt impelled to make such written comments might raise concerns in any worldly and sceptical mind.
The potential impact of such biases is focused by reminding ourselves that almost none of the data about a new drug presented to regulatory authorities in western countries comes from any source other than the interested party, ie the manufacturer. Whilst one hopes that outright dishonesty in the way such data might be presented is extremely rare it is relevant to appreciate that more subtle biases may be more important. It is likely that potentially unfavorable data relating to side effects and dangers of drugs will be given lesser consideration and weight by partisan persons employed by the drug company than it is by independent researchers.
The message is simple: the assumption that because a drug is on the market it is therefor effective and safe may well be unjustified. Post-marketing assessment and monitoring by 'ordinary' doctors is vital, as is independent comment and criticism. That is part of the role of 'Psychopharmacology Update Notes'.
Gillman's maxim No 9
Considering sponsored drug trials to be reliable and objective evidence may be compared to buying a second hand car after getting the salesman to take it for a test drive for you.
All text ©Dr Ken Gillman MRC Psych - PsychoTropical Research®
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