HALF A MILLION DOWNLOADS REACHED - Helping Safeguard children from psychiatric drug harm due to possible severe toxic side effects. We need alternatives like psychological interventions, physical activity, or mindfulness training as a first course of action. Let's 'Enable not Label' kids to give them better futures - - - - - - - - -"There can be no keener examination of a society's soul than the way it chooses to treat its children." - - - - -
- Nelson Mandela
The claim that there is an "innovation
crisis" in pharmaceuticals because of the difficulty and expense of
discovering new drugs is a myth fostered by an industry whose chief focus is on
marketing, they add.
Counter to drug industry claims that the pipeline
of new drugs is running dry, the number of new drugs being licensed each year
has remained at between 15 and 25. But most involve minor tweaks to existing
drugs, designed to grab a slice of an existing market rather than offering
genuine therapeutic innovation.
Independent reviews suggest that 85 to 90 per cent
provide little benefit over existing treatments with some, such as Vioxx the
painkiller and Avandia, the diabetes drug, causing serious side effects which
led to their withdrawal, the latter's in Europe.
Writing in the British Medical Journal, Professor
Donald Light from the University of Medicine of New Jersey and Joel Lexchin
from York University in Toronto say the situation has remained the same for 50
years. The incentives for drug development are wrong and have skewed the
behaviour of the industry.
"This is the real innovation crisis:
pharmaceutical research and development turns out mostly minor variations on
existing drugs and most new drugs are not superior on clinical measures. [They]
have also produced an epidemic of serious adverse reactions that have added to
national healthcare costs," they say.
More is spent on marketing (25 per cent of
revenues) than on discovering new molecules (1.3 per cent). Drug industry
claims that the cost of bringing a new drug to market is £1bn and is
unsustainable are exaggerated, they claim. Research and development costs did
rise substantially between 1995 and 2010 by $34.2bn (£21.9bn), they concluded,
but revenues increased six times faster – by $200.4bn.
Companies avoid mentioning this "extraordinary
revenue return", they said, adding that up to 80 per cent of drug spending
is used by the industry on promotion. The authors call for licensing authorities
around the world to stop approving new drugs of little therapeutic value. They
suggest large cash prizes should be awarded for genuinely new therapeutic
agents in lieu of patent protection.
The European Medicines Agency, which licenses drugs
in the UK and Europe, keeps certain data about their safety and efficacy
secret. Yet 29 per cent of new biological agents approved by the EMA received
safety warnings within the first 10 years.
In a second paper, researchers from the London
School of Economics in the UK argue that drug manufacturers should be made to
demonstrate that their products are superior to existing treatments before
being granted a licence, rather than, as now, superior only to a placebo.
"Changing the nature of regulation could
encourage manufacturers to concentrate on the development of new drugs in
therapeutic areas with few alternatives," they say. "Supplementing
regulation with scientific advice and guidance can steer manufacturer's
interest and efforts into key research priorities."
Stephen Whitehead, chief executive of the
Association of the British Pharmaceutical Industry, said: "We strongly
disagree with the claims made in these papers. Medical research has always
rested on iterative and gradual innovation rather than breakthrough advances
which are very rare. If it were not for the incremental improvements made in
the treatment of HIV, the disease would still be terminal rather than a