The miracle cure myth: today's pharmaceutical cures are often no better than the ones pioneered 50 years ago. Yet there are plenty of experts telling us the opposite - Health
The public image of the pharmaceutical companies has rarely seemed rosier. They may be immensely rich and powerful following a spate of mergers that created a dozen corporations, each with a turnover of billions of pounds, but they are also committed to making the world a better place, deploying science to alleviate the misery of illness, and perhaps even saving some of us from an untimely death. The pharmaceutical giants have worked hard to project this perception of their task through their generous sponsorship of meetings and annual awards for aspiring scientists and Journalists.
However, there is another, admittedly minority, view from within medicine that the industry is set to bankrupt, both morally and financially, the health services of the western world. We start with David Horrobin, a former physician who now runs his own small but successful drugs company. "The main issue," he wrote in the Journal of the Royal Society of Medicine, "is that in order to sustain average growth, the industry needs between 70 and 100 new products a year worth around [pounds sterling]300m each, or a larger number of smaller products or a smaller number of larger ones."
This rate of successful innovation is necessary to maintain profitability, but particularly to offset phenomenal research and development costs, which can now run to [pounds sterling]500m to bring a single new drug to market. The cumulative effect of this revenue requirement over the next 15 years -- which is the average patent life of a new drug -- can be calculated by multiplying the 70 new drugs a year by the [pounds sterling]300m average sales by 15, which works out at around [pounds sterling]15bn per annum. This may seem, and indeed is, a lot of money, but historically pharmaceuticals have accounted for only a fraction of total health service costs, which must also include hospital building programmes, equipment, salaries and wages.
These future projections, where drug costs will impose an increasingly disproportionate financial burden on western health services, are in line with the trajectory of the recent past, where the drugs bill has quadrupled in the United States over the past two decades. As Charles Medawar of the pharmaceutical watchdog Social Audit has observed, "expenditure of this order would cripple the national healthcare provision enjoyed in EU countries and elsewhere".
Horrobin's second and apparently paradoxical point is that, while drug companies must produce a constant stream of new and profitable drugs, the rate of genuine therapeutic innovation -- drugs that are significantly better than those already available -- has declined precipitously. So whereas, back in the 1960s, pharmaceutical research was capable of generating 100 new chemical entities a year, the current figure is a third of this, only a few of which will ever make it to the market place.
The reasons for this fall-off in research productivity lie in the phenomenal success of the golden age of drug innovation in the immediate postwar years, which saw the introduction of 27 anti-infective and 16 anti-cancer drugs, 12 drugs for the treatment of psychiatric disorders and 16 for rheumatological conditions, 24 for circulatory disorders such as heart attacks and raised blood pressure, not to mention five antihistamines, ten synthetic steroids, 13 anti-epileptic drugs, 18 analgesics, 15 nutrients and seven preparations for the relief of poisoning.
It was the windfall profits from this extraordinary period, when research costs were considerably less than nowadays, that created the basis for today's pharmaceutical giants. But these drugs no longer provide significant revenues, because their patents have long since expired.
This leaves the pharmaceutical industry with two options. The first is to invest heavily in basic research to define more precisely the cellular, genetic and biochemical processes involved in diseases such as cancer or Alzheimer's, in the hope that this will lead to novel therapeutic approaches. This is certainly the manner in which medical progress is widely believed to occur, and the industry has indeed allocated billions of pounds in the expectations that the goose of the new genetics techniques will produce its extravagantly promised golden eggs -- but so far to little avail.
Meanwhile, argues Horrobin, the huge research effort required by this type of big science has proved inimical to the intuitive individual genius that accounted for so many of the discoveries of the golden age. There have been exceptions, such as the new generation of Aids drugs, hepatitis B and other vaccines, and a handful of genetically engineered hormones such as insulin, but their therapeutic possibilities have proved to be much more limited than the simple synthetic chemistry that built the industry's fortunes in the 1950s and 1960s.
The second, easier and preferred. option is to go for the "better mousetrap" -- a new and improved but much more expensive version of drugs that are already available; or the "useless mousetrap" -- drugs that don't work, or at least not very well, for the treatment of, say, Alzheimer's or cancer, but are promoted on the grounds that they are better than nothing at all. Indeed, most of the current top ten "blockbuster" drugs -- the ones that generate the billion-pound revenues which sustain the industry's profits -- are more expensive variants of drugs that were originally developed 20 or more years ago.
To be specific, there are a lot of people with depression for which the current vigorously promoted treatment, Venlafaxine, costs [pounds sterling]24 for a month's course of treatment, compared to [pounds sterling]14 for the previous antidepressant "wonder drug" Prozac -- which is soon to come off patent, and which it is hoped Venlafaxine will replace -- and a mere [pounds sterling]8 for Prozac's predecessor Anafranil, though a generic variant of this would probably cost half that amount. Flow to justify this cost differential? There is currently considerable controversy over whether antidepressants work as intended or through the placebo effect, but there is no doubt that they can prove dramatically effective.
In Britain, in the decade following the introduction of Prozac, the cost of antidepressants to the health service rose from [pounds sterling]54m to [pounds sterling]147m. Now that the star of Venlafaxine is rising, this antidepressant bill can be guaranteed to increase yet further.
And is Venlafaxine so much better than Prozac or Anafranil? Yes, said Dr Michael Thase, professor of psychiatry at the University of Pittsburgh School of Medicine, in a paper published in the British Journal of Psychiatry last year, which argued that it was "significantly" better at curing depression. Professor Thase is a paid consultant to Wyeth, the manufacturers of Venlafaxine, which is duly acknowledged. But the editor of the journal, Dr Greg Wilkinson, who decides which papers will be published, turns out also to have an interest, being a board member of an educational organisation that is sponsored by Wyeth, and whose publications give prominence to the new drug. Tut, tut, the Lancet observed disapprovingly in an editorial titled "Just how tainted has medicine become?". An earlier Lancet editorial had argued: "The matter of malign commercial influence in research is complicated by investigators' own conflicts of interest. As research becomes driven by ever more costly procedures, so industry will intrud e even further into the scientific process."
Whether Venlafaxine is or is not significantly better at curing depression, this episode reveals the degree to which the medical profession is now in thrall to the pharmaceutical industry. This is not to suggest that the doctors who conduct the trials or write up the papers are being deliberately misleading, but the pervasive influence of the drug companies is inescapable, and doctors become, willingly or not, the respectable front by which these companies promote their mousetraps.
And this is just to scratch the surface. Big pharmaceutical concerns, through their support for patient self-help groups and by advertising directly to the public, have managed to fuel the demand for their products. This phenomenon is the inevitable reverse side of a dynamic and progressive ideology that gave us the therapeutic revolution of the golden years.
The drug companies, as capitalist enterprises, cannot escape the imperative to innovate; they cannot impose restraints upon themselves, but rather must pursue every avenue to ensure a market for their costly wares.
It is not unreasonable, as Horrobin suggests, to contemplate a time -- perhaps not too far ahead -- when the complex priorities of the health services of the western world have become so distorted that a system of free and equitable healthcare can no longer be sustained. |