KEI
research associate Paul Miano has written the following paper: Cancer:
Approval, ownership, market structure, and placement on WHO Model Essential
Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of
cancer drugs and vaccines. KEI Research Note 2011:1,
A full
copy of the paper is available in PDF format here.
The
following is from the introduction (sans footnotes, which are in the PDF
version):
Introduction and Summary
This
research note presents data on the approval, ownership, market structure and
placement on the WHO Model Lists of Essential Medicines new molecular entities
(NMEs) approved by the U.S. Food and Drug Administration (FDA) for the
treatment of cancer. The examined products, which include both drugs and
vaccines, are those included in the U.S. National Cancer Institute (NCI) “alpha
list” of cancer drugs. The July 2011 version of the alpha list includes 100
unique molecular entities, as well as a number of new formulations or combinations
and chemotherapeutic regimens. Our analysis focuses on the 100 unique molecular
entities.
Each of
the products was approved by the FDA through one of two mechanisms. For
pharmaceutical drugs, products are registered under a New Drug Application (NDA).
For biologic products, registration is through a Biologic License Application
(BLA).
Among
our findings are the following:
1.
The role of biologic products has increased
1.1 Of the
100 drugs and vaccines, 79 were registered under New Drug Applications
(NDA) and 21 were registered under Biologic License Applications (BLA).
1.2 From
January 1, 2000 to July 2011, 15 of 52 products were biologics, or 29
percent of the total.
1.3 For the
48 products registered before 2000, 6 of 48 were biologic, or 12.5 percent
of the total.
2.
Registrations have increased, and most cancer drugs are relatively new
2.1 Despite
an overall decline in the registration of NME products in recent years,
there has been a sharp rate of increase in the registration of NME products
for the treatment of cancer.
2.2 In the
38 years from 1952 to 1989, there were only 21 NME on the NCI list, an
average of .55 per year.
2.3 In the
ten year period of 1990 to 1999, the list contains 27 NME cancer products
- an average of 2.7 per year.
2.4 In the
ten year period of 2000 to 2009, 45 NME cancer products were registered -
an average of 4.5 per year.
2.5 For
2010 through the July of 2011, 7 NME products were registered, an average
of 4.4 per year.
2.6 More
than half (52 of 100) of all cancer NME products were first registered
after January 1, 2000.
3.
Most drugs are only available from a single supplier
3.1 66 of
the 100 products are only available to one FDA approved supplier or a
joint venture managing the same brand name, suggesting strong barriers to
entry due to intellectual property rights and other factors.
3.2 45 of
79 pharmaceutical drugs (57 percent) do not have competitive suppliers.
3.3 21 of
21 biologic products (100 percent) do not have competitive suppliers.
3.4 For
products registered between January 1 2000, and July 2011, 51 of 52
products (98 percent) do not have competitive suppliers.
4.
Ownership is concentrated in six countries, and among thirteen companies
4.1 28
companies own or control the sale of the 66 drugs that do not have
competitive suppliers.
4.2 13
companies control more than one cancer monopoly, including:
GlaxoSmithKline
(9), Amgen (5), Novartis (5)
4 each for
Sanofi, Bristol Myers Squibb, Celgene and Roche
3 each for
Eisai, Merck, Astrazeneca and Eli Lilly, and
2 each for
Pfizer and Cephalon
4.3 In
terms of nationality, just six countries host the companies that own and
control cancer products sold as a monopoly.
4.4 One
half (33 of the 66) monopoly products are controlled by firms located in
the United States.
4.5 Of the
remaining 33 monopoly products 12 are controlled by UK firms, 11 by firms
in Switzerland, 5 by firms in Japan, 4 by firms in France and 1 by a firm
in Germany.
5.
The WHO Model Essential Medicines List excludes all new cancer drugs
5.1 The
March 2011, 17th Edition of the WHO Model Essential Medicines List (EML)
includes zero products from the NCI alpha list of cancer drugs on its
“core” list of the minimum medicine needs for a basic health care-system.
5.2 The
17th Edition of the WHO Model EML includes 20 products from the NCI alpha
list on its “complementary” list of “essential medicines for priority
diseases.”
5.3 For the
2011 WHO Model EML complementary list, the newest product that is also on
the NCI alpha list was registered 15 years ago, in 1996.
5.4 The
newest cancer product on the 2002 version of the complementary WHO Model
EML was first registered 19 years earlier, in 1983.
Note:
These are the 100 "alpha list" drugs and vaccines included the paper:
No
INN (generic name) of products on NCI`s Alpha List
of cancer drugs
