There is a growing
and justified concern in the pharmaceutical field for what might be called innovation crisis in the development of
novel antibiotics. The issue has gone beyond the health field, having been
discussed at a meeting of the World Economic Forum.
The World Health
Organization has warned that we are moving into a "post-antibiotic era".
It is increasingly common that deaths occur as a result of bacterial infections
which are either refractory to all known drugs, or the germs have acquired
plasmids which make them resistant to antibiotics to which they were once sensitive.
Since the late
1980s no new kinds of antibiotics have emerged. Between 2011 and 2013, the
F.D.A. (Food and Drug Administration) has approved only three novel
antibacterial drugs, the lowest number of innovations since the 1940s, when the
antibiotic era began. There are experts who do not hide their pessimism. Such
is the case of Michael S. Kinch, of Yale Center for Molecular Discovery team.
The pharmaceutical
industry has found a goldmine in the field of immunology and genomics for the
development of profitable drugs ranging from monoclonal antibodies to the
latest gene therapies. Today, pharmaceutical progress is focused on finding
personalized treatments for diseases such as cancer and chronic disease, but
also in developing new types of vaccines, and new drugs for widely prevalent
diseases such as hepatitis.
However, this
approach does not contribute significantly to raising the standards of public
health. To this aim, antibiotics are a high priority strategy.
An increasing
number of antibiotics are removed from the pharmaceutical market each year due
to the emergence of resistant micro-organisms, or they are replaced by similar
alternatives (the so-called "me too"). The pharmaceutical antibiotic
arsenal consists currently (October 2014) of 96 molecules, 17 less than there
were around the turn of this century.
An additional
concern is the pharmaceutical corporations’ lack of interest in the discovery
of new antibiotics; and even less in the search for new sorts of antibiotic
molecules. This is due to a lack of sufficient incentives to engage in
intellectual adventures of ten years, or longer, in the future, and with no
guarantee of success.
In addition, antibiotic
research faces a grim future. Its development is difficult and economic
benefits may not justify the intellectual and financial investment required.
Unlike drugs for diseases that require prolonged treatment, antibiotics are
used for short periods, usually a few days or weeks at the most. Moreover, the
new antibiotic molecules are prescribed sparingly in order to avoid the
development of resistance, exceeding their patent protection time, so the
manufacturer does not obtain the profits they expect.
The above problems
in the search for new antibiotics can be extended to drugs used to treat HIV
infection and its associated disease, AIDS.
Psychiatric and
neurological diseases, including Alzheimer's dementia, are a major source of
disability in the developed world.
However, biotech
pharmaceutical companies have focused disproportionately on personalized
therapies, many of which are drugs for "orphan diseases”. With irony, it
can be said that "there are more people studying orphan diseases than
patients affected by them." Of all drugs approved by the U.S. Food and
Drug Administration in the year 2013, 70% were aimed at diseases affecting less
than 1% of the population.
It is necessary to give
incentives to the pharmaceutical industry. The costs of developing new pharmaceuticals
for widely prevalent diseases have increased steadily, lowering profits.
According to experts from Eli Lilly in 2010, the estimated cost of marketing a
new drug is around $1.8 billion, requiring that each new drug be less toxic and
more effective than existing therapies.
However, the
development of orphan drugs is cheaper. The requirements for the approval of
orphan drugs by the regulatory agencies are less rigorous. Clinical trials are
carried out on a smaller number of patients. In addition, the insurance companies
include these treatments in their coverage of their clients. Although these
drugs are not blockbusters (their global annual turnover rarely exceeds $500
million), investment for their development and marketing is also not as
expensive.
“Classic"
drugs lose 80% of the market share within 1 year of patent expiry. Whereas biological
drugs have an "additional protection" derived from the difficulty in
the manufacture of generic versions and standardise these to the original drug.
An important issue
is: can fixed incentives to drug manufacturers be established? The system of
patent protection has been regarded, so far, as a valid procedure. But
experience is showing that it is not enough.
Returning to the subject
of antibiotics should relax the requirements for the approval of new drugs, and
increase exclusive sales rights for new kinds of antibiotics.
The myth that
"market forces" regulate prices does not work, at least in the field
of pharmaceutical research. The market (free market) does not represent an
incentive for innovation, especially in societies where taxation stifles the
desire to take risks.
Zaragoza (Spain), October, 11th, 2014
López-Tricas, JM MD
Hospital
Pharmacist
Zaragoza
(Spain)
