Monday, June 26, 2006

Future of the Pharmaceutical industry - new attack on ethics - pushing lifestyle issues

A new report in the Public Library of Science Medicine has again accused the pharmaceutical industry of unethical behaviour, this time by “disease-mongering” and “lifestyle” treatments for minor problems.

This comes at a time when AstraZeneca, Shire Pharmaceuticals, GSK and others are reporting strong profit growth.

The problem for the report is that it seems to ignore the pattern of history of medicine.

As society has become more affluent, and as medical progress has continued, each generation has tended to think of illness in a new way.  Issues that were considered just the inconveniences of life in previous decades now become treatable conditions which people are wanting help with.

I often talk of above the line and below the line:  above is medical, below is performance or lifestyle – but the line keeps falling.

IVF – was below the line in the UK, a fact of life if you are infertile.  But now has become a treatable condition under the NHS.

Cosmetic surgery was entirely below the line except when dealing with injuries, but in today’s NHS even a total sex change operation is now above the line, as is just about any kind of cosmetic surgery if a strong enough case can be made about the psychological damage being caused.

Hair loss in women – above the line.

Hair loss in men – below the line.

Impotence – definitely now above the line.

Mental enhancement drugs in older people with memory loss – above the line.

Mental enhancement drugs in older people without memory loss – below the line.


The big issue for the future of the pharmacueutical industry is to get accurate predictions about how that line is likely to move in the next 5-15 years – but that in turn also depends on what new options become available.

Sunday, June 25, 2006

Repair of inner ear - deaf cure - using stem cells

For a while I have been working on the idea that we will one day be able to repair deafness – which is a universal problem for all those over the age of 75.  In fact you can find some kind of hearing loss in anyone over the age of 55 if you look hard enough.


The market for a cure for deafness is huge.


In Nature this month there is a report by Neil Segil and colleagues at the House Ear Institute in Los AngelesUniversity of Southern California – in which they show they have made new hair cells from adult stem cells in the inner ear.


These cells have turned off production of a protein p27.  This offers a possible drug route to cure deafness, by blocking the p27 system and encouraging these cells to develop into new hair cells.


The work was done in culture but is still very exciting.


This is not the first time that scientists have explored ear cell regeneration.


It is becoming clear from many different studies that repair of the retina, inner ear, spinal cord, heart or brain will one day be relatively easy.


The challenge for the future of the pharmaceutical industry will be to be able to develop a drug which can encourage these cell-based transformations without removing cells in any way.  Watch this space – many different teams in biotech companies are actively developing solutions along these lines.

Saturday, June 24, 2006

Transplant patients receive own cells

The first patients have received organs grown from their own tissue in the laboratory.  Bladders have been grown from people’s own muscle and bladder cells – work done by the Advanced Urology Institute in Illinois.  I think the whole are of tissue regeneration is set to take off over the next 3-5 years.


For more on stem cells and other similar issues of tissue regeneration see:



Sunday, June 11, 2006

Cure for Alzheimers disease?

I shared a platform with Baroness Susan Greenfield this week at an event for Munich Re.  Susan is also Professor of Pharmacology at Oxford University and a leading authority on neurophysiology.


We talked about new approaches to treatment of Alzheimers disease.  The key will be to find surrogate markers which indicate early progression before symptoms appear of memory loss.  This will mean far shorter clinical trials.  We will be able to see rapidly if drugs work or not, by observing if further losses of brain cells have occurred and if so at what speed, regardless of whether there are any noticeable effects on mental performance.


Susan is confident that we will find reliable surrogate markers and also some interesting new therapies which will slow down or stop the deaths of brain cells.  While such treatments will not reverse previous damage, surrogate markers will allow very early intervention.


Susan also showed interesting studies on the impact of brain stimulation.  The brain remodels itself every day, with new neuronal connections made as a result of experience.   There is strong evidence from many studies that mental effort of all kinds is linked to formation of new neuronal connections, and the more of these we have, the greater our so-called cognitive reserve, or capacity to withstand loss of brain cells.

Tuesday, June 06, 2006

Pharmacueutical industry faces fresh pressure on intellectual property

Expect new pressures on the pharmaceutical industry when it comes to protecting the patents on their product portfolio.

In some territories such as China the situation is far from clear from the legal point of view. But even if a pharmaceutical company feels it has a strong case, the real question is whether the corporation has the moral strength to pursue a court battle.

As we saw in the collapse of a prominent legal battle in S Africa over the use of generic drugs against HIV, the industry as a whole shows little appetite for big, highly publicised legal cases.

The more urgently needed a drug is to help save lives in the poorest nations, the greater the probability that the patent owner will be under pressure to allow other manufacturers to make and sell more or less at cost, or to cut their own market price.

Future blockbuster drugs are therefore more likely to be those which are targetted at developed markets, for lifestyle or chronic conditions.

In the meantime the cost of developing a new drug is approaching $1bn, and the time needed for the whole process of discovery through to marketing can be as long as 15 years, further eroding the 25 year protection interval for exploitation of a discovery.

Monday, May 01, 2006

Olive oil antiinflammatory effect

Interesting report in New Scientist recently showing that 50mls per day of olive oil in the diet is equivalent to a dose of ibrupfofen.  We are increasingly recognising the impact of diet on disease processes.  Expect to see new ranges of neutraceuticals:  products with nutrition as well as therapeutic effects.  Many of these will be artificial creations such as bananas which contain a vaccine.

Sunday, April 30, 2006

Threat from generics in an online world

A few months ago there were two prices for Cipro online: the price in New York $5 a tablet, and in Delhi 35c a tablet.

One was made officially, the other was an "illegal" generic.

In the old days before the web such a thing would hardly have mattered so long as generics stayed in emerging economies where sales of the high priced alternative would have been almost zero.

But in the net world, with Fedex and other carriers able to carry packets in a day, and customs / regulators overwhelmed, more or less any medicine can turn up in any country from any source.

Expect countries like India and China to tighten up their intellectual property regulations, while other emerging nations quickly fill the gap as safe havens for unauthorised generic manufacturing.

Saturday, April 29, 2006

Why pipelines are so empty

Around 75% of all pharmaceutical research spending is by the very few largest companies, while around 66% of all new innovation is being carried out by many hundreds of smaller independent biotech startups and similar organisations. In many pharma companies most of their work is still driven by extending the functionality and patent protection of existing therapies.

Meanwhile it now costs over $800 million to bring a new drug to market, and can take 15 years. The entire model is becoming unsustainable. Expect significant reforms and changes in pharma structure over the next decade.

Friday, April 28, 2006

Inventing disease or true unmet need - accusations against pharmacuetical industry

The future of the pharmaceutical industry will be dominated by innovation, much of it biotech driven.  But success depends on linking new product innovation to genuine unmet need.  The accusation is that some pharma companies have been inventing new treatment areas and diseases to maximise revenue from drugs that would otherwise have low sales.


However, at the end of the day the only real judge of unmet need is the person who is suffering.  As a physician myself I know how blind doctors can be to the true toll of illness on those who come to them.  An obvious example is the relief of pain in hospice medicine (my own specialty in the days when I was a practising doctor).  The entire hospice movement has been created in part to solve a nightmare for cancer patients – untreated pain and other major symptoms, despite the fact that many highly effective therapies are available.  Doctors are often ignorant, or afraid to ask the questions and patients often hold back from revealing the truth.  The reasons for these things are complex, but this is just one example where surveys of unmet need show huge differences between what doctors think is happening, what patients tell their doctors about and what patients actually experience.

Thursday, April 27, 2006

Future of the Pharmaceutical Industry

Future of the Pharmaceutical Industry - articles and presentations