The article in BMJ is highly
recommended to read. A lot of facts in a form of cold numbers and a very sober
conclusion:
Data indicate that the widely touted
“innovation crisis” in pharmaceuticals is a myth. The real innovation crisis stems
from current incentives that reward companies for developing large numbers of
new drugs with few clinical advantages over existing ones.
Some
quotes:
The preponderance of drugs without
significant therapeutic gains dates all the way back to the “golden age” of innovation.
Out of 218 drugs approved by the FDA from 1978 to 1989, only 34 (15.6%) were
judged as important therapeutic gains. Covering a roughly similar time period
(1974-94), the industry’s Barral report on all internationally marketed new
drugs concluded that only 11% were therapeutically and pharmacologically
innovative.13 Since the mid-1990s, independent reviews have also concluded that
about 85-90% of all new drugs provide few or no clinical advantages for patients.
How have we reached a situation where so
much appears to be spent on research and development, yet only about 1 in 10
newly approved medicines substantially benefits patients? The low bars of being
better than placebo, using surrogate endpoints instead of hard clinical
outcomes, or being non-inferior to a comparator, allow approval of medicines
that may even be less effective or less safe than existing ones.
[M]arketing has become “the enemy of [real]
innovation.” This perspective explains why companies think it is worthwhile
paying not only for testing new drugs but also for thousands of trials of
existing drugs in order to gain approval for new indications and expand the
market. This corporate strategy works because marketing departments and large
networks of sponsored clinical leaders succeed in persuading doctors to
prescribe the new products. An analysis of Canada’s pharmaceutical expenditures
found that 80% of the increase in its drug budget is spent on new medicines
that offer few new benefits.
And the
following quote is my favorite one!
This hidden business model for pharmaceutical research, sales, and
profits has long depended less on the breakthrough research that executives
emphasise than on rational actors exploiting ever broader and longer patents
and other government protections against normal free market competition.
Companies are delighted when research breakthroughs occur, but they do not
depend on them, declarations to the contrary notwithstanding. The 1.3% of
revenues devoted to discovering new molecules compares with the 25% that an
independent analysis estimates is spent on promotion, and gives a ratio of basic
research to marketing of 1:19.
There are a
lot of other very interesting and reasonable ideas and facts in this article. I
have written about the very bad situation with the innovations and how Big
Pharma is not interested to promote them, Ok, but here we have a second opinion
in face of two (I am sure) very clever and honest professors. I suspect that
they have to be communists…
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