Wednesday, April 19, 2006

Daily Mail Big Pharma Feature

Jacky Law investigates how pharmaceutical companies make billions of dollars by persuading people they need their treatments. Is this the real drug abuse?

Wednesday, April 12, 2006

Interview with Radio New Zealand

A half hour breakfast interview with Radio New Zealand's top broadcaster about the dominance of the pharmaceutical industry in healthcare.

http://www.radionz.co.nz/audio/national/sat/jacky_law

Thursday, March 23, 2006

Big Pharma in the New Zealand Listener: Controlling the NZ drug budget


In Unhealthy Profits, a lead story in the March 25 2006 issue of the New Zealand Listener, Sally Blundell takes Big Pharma’s themes and plays them out via New Zealand’s efforts to reduce its national drugs bill.

'Big Pharma: How the world’s biggest drug companies control illness', by UK pharmaceutical journalist Jacky Law, shows how, in the name of health, the line between commercial gain and public interest has become increasingly blurred.

“‘A few companies have become massively influential in how old age and sickness are seen, and in how the scientific community sets its gaze in addressing those sufferings,’ Law says in a telephone interview from her home in Surrey. ‘We allow the pharmaceutical industry enormous leeway in terms of our understanding of life and death and science, and what it is to be healthy’

New Zealand is interesting in the world of pharmaceuticals because it is the only country other than the US that allows companies to advertise their products to the public. Pharmac, the government agency responsible for managing the national drugs budget, is more in the public eye and therefore more accountable to public concerns.

Blundell says Pharmac has succeeded in curbing what was beginning to be an exponential increase in pharmaceutical spending, driven by the rising costs of new drugs. But also that it is relentlessly attacked, despite accounting for less than one percent of the global US$500 billion annual spend on medicines, in case other countries try to copy its model.

Blundell takes up the arguments of Big Pharma. “As governments around the world struggle to meet the price tags on new medicines, Law asks why these new drugs are so costly. ‘I do think we need to unpick some of the industry’s assumptions – that higher prices equal better drugs, for example.”

Extract from the article "Unhealthy Profits" by Sally Blundell in the March 25th 2006 issue of the New Zealand Listener

New Zealand Listener

Monday, March 20, 2006

Book review in the British Medical Journal, 18 March 2006, by Ike Iheanacho


The pharmaceutical industry is a business. This banal and obvious fact needs emphasising because it is often forgotten or overlooked by both supporters and critics of the industry's ethos and activities. And the industry itself is happy to downplay its true motivations where this suits the circumstances. It can, for example, pose instead as educator, charity supporter, health service provider, and even patient advocate.

While such roles hardly mask the underlying commercial imperative, observers may be reluctant to consider them primarily in business terms. This would be a mistake, not least because, when viewed in this way, there is much to admire about the pharmaceutical industry.

Other industries could perhaps learn from its energy, professionalism, flexibility, and ability to ensure that its interests are well represented wherever key healthcare decisions are taken. What is more, a focus on the pharmaceutical industry as a business need not deny the great advances the industry has provided and continues to offer, or the good intentions of many who work in it.

Indeed, the difference between the interests of industry and the public good is not necessarily a problem. Where medicines are affordable and scrupulously regulated, and offer genuine therapeutic benefits, the overlap between public health and the legitimate business interests of industry can be self evident. There is a danger, however, in taking such overlap for granted.

Multinational pharmaceutical companies grew big through producing and promoting innovative medicines for major diseases. But it becomes ever more difficult and expensive to repeat such successes. Increasingly, therefore, the companies stay big by identifying and promoting diseases for their major medicines and refashioning and repackaging old products as "innovations."

Also, they commonly operate under regulatory and other statutory arrangements that appear to assume that what industry produces is inevitably worth having—an approach that is more patent focused than patient focused. In this environment, assuming or pretending that there is a direct relationship between industry's efforts and improvements in public health is, at best, naive.

These issues form the core of Jacky Law's excellent treatise on how major pharmaceutical companies dictate which healthcare problems are researched, publicised, and provided for. This concept is not novel. But what Law adds is a highly readable synthesis of evidence and commentary to argue how and why the pharmaceutical industry fails to address healthcare issues that really bother people.

The author is clearly no great fan of the industry. But, refreshingly, she avoids the sort of lazy polemic that casts major pharmaceutical companies as an evil empire that continually foists its products on unwilling and unsuspecting healthcare professionals and patients. Nor does she shy away from criticising those outside the pharmaceutical industry—government, regulators, doctors and patients—who have encouraged or acquiesced in the industry's way of doing things.

Tracing the development of the modern pharmaceutical industry, Law correctly cites the failure of what she calls "the deal"—a regulatory framework broadly based on the idea that pharmaceutical companies always produce worthwhile products that society will automatically buy. In hindsight, of course, this settlement seems woefully optimistic. But it is important to remember that it came about at a time when companies really were producing innovative medicines relatively easily; when such development was affordable; when patients were passive and trusted doctors; and when doctors trusted the medicines. And even now, as the book makes clear, the guiding principles of the deal remain in place, despite being increasingly unfit for purpose.

A key example in the UK is the Pharmaceutical Price Regulation Scheme, the unique, grotesquely brilliant arrangement that dictates how much overall profit a major pharmaceutical company can make through sales of its brand-name products to the NHS. The scheme helps to control the national drugs bill. However, it also deliberately uncouples the price set, and the profit made on, an individual product from the costs incurred in developing, testing, and promoting that product.

The "deal" was bound to fail through the spiralling costs and increasing difficulty involved in producing genuinely innovative medicines, and society's mounting disinclination to pay, particularly for products of questionable value. These economic realities have been compounded by recent high-profile instances of regulatory failure, in particular, the problems surrounding the use of rofecoxib (Vioxx) and selective serotonin reuptake inhibitors. The book concisely reviews the evidence indicating that in these cases regulators repeatedly favoured the interests of pharmaceutical companies above those of patients.

Such information forms a key part of Law's championing of active and representative involvement in individual and societal decision making about health care. This view is compelling given the lack of trust patients and the general public have for regulators and the wider medical establishment. However, much less convincing is the book's suggestion that the UK government should have addressed parents' scepticism about official advice on the MMR (measles, mumps, and rubella) vaccine by making alternative single vaccines available on the NHS. This highly questionable proposal seems a rare lapse in an otherwise tightly argued text.

The final third of the book highlights how moves to strengthen and ensure more balance in the doctor-patient relationship could help lessen the often distorting influence of the pharmaceutical industry. This suggestion may seem wildly hopeful, particularly given the industry's proved adaptability. But as Law herself concludes, it would be a good start.

Ike Iheanacho, editor Drug and Therapeutics Bulletin

Rating: 3

Items reviewed are rated on a 4 star scale (4=excellent)



  • British Medical Journal
  • Sunday, February 26, 2006

    Sunday Times Cartoon by Kipper Williams


    Big Pharma was the focus of Kipper Williams' deft hand in a cartoon on Page 58 of the Sunday Times Culture section, February 26, 2006.

    Wednesday, February 22, 2006

    Management Today review of Big Pharma

    Dr Richard Horton, editor of the Lancet, describes Big Pharma as a 'must-read' in the Febuary 2006 issue of Management Today.

    This urgent exposure reveals a pharmaceutical industry suffering a catastrophic collapse in its reputation. Can it heal itself?

    "The pharmaceutical industry displays the best and worst traits of modern western democratic societies. There is no other entity today that takes the arcane products of scientific research and translates their remote prospects into the magic of medicine. The astonishing alchemy of this process is the apotheosis of capitalism.

    "The ambition and achievement that market states encourage in the service of human illness are some of the most remarkable attributes of our species ever recorded. And yet the mendacious excesses that drug companies indulge in at moments of weakness and crisis also point to some of the most venal and debauched aspects of human life.

    "The industry manufactures diseases as well as drugs. It loads the dice of research before that research has even begun. It creates incentives to cheat. It manipulates science to serve marketing, not medicine. It conceals bad news. It is willing to tolerate epidemics of harm caused by its products in order to protect profits. It brutalises compassion, turning disease into simply one more commodity to be traded and exploited. ..

    "In Big Pharma, Jacky Law, a specialist journalist, ably traces the origins and recent history of these extreme boundaries. She recognises and pays tribute to the real successes that industry has delivered.

    "This book is a must-read. Law has drawn on a remarkable range of sources to produce an urgent analysis of one of the most powerful but little-understood industries. Her arguments are compelling and her conclusions disturbing.

    http://www.mtmagazine.co.uk/public/news/index.cfm?fuseaction=fulldetails&newsUID=8f34b560-4629-4cbc-adef-2be609248b27

    Good Clinical Practice Journal review of Big Pharma

    Good Clinical Practice Journal issue March 2006. Review by Jenine Willis

    "With the recent scares - namely with the COX-2 inhibitors and SSRIs - patients have even more cause to worry about their health. Are treatments doing more harm than good? This book isn't going to reassure patients, but it does try to arm them with information and an understanding of the limitations of healthcare and medicines.

    "Although not overplayed, the book does point out how patients could help themselves if they have more realistic expectations of what medicines can do. The author explores the placebo effect and points out that it could play a positive role provided patients have faith in their doctors...

    "Big Pharma's strength lies in its broad brush approach. It is a panoramic view of the network of connecting, conflicting and complementing interests of the three main stakeholders in healthcare: industry, medicine and the public. And in this it is an achievement which I haven't seen elsewhere...

    http://www.pjbpubs.com/gcpj/index.htm

    Evening Standard Review of Big Pharma

    Extract of review by William Leith in the London Evening Standard February 13, 2006

    "Throughout this book, Law tells us that the profit motive perverts the course of medicine, and making us feel iller than we are is a key tactic.

    "Of the pharmaceutical companies, or Big Pharma, as she collectively demonises them, Law says, 'Increasingly we allow them to set yardsticks that suggest our collective wellness is less than it might be.'

    "If you read this book, you'll ask yourself serious questions about every pill you take, whether it's a beta-blocker or an aspirin. You'll think: 'Is this good for me? Or is it good for them?'"

    Wednesday, February 15, 2006

    Sunday Times Review - Big Pharma by Jacky Law


    Sunday Times Book Reviews 12 January 2006
    By Philip Knightley

    "We need to seize back control of our medical destinies, and this book’s great strength is that it inspires us to do just that."

    "If you thought that you knew the worst about the pharmaceutical industry, think again.

    Jacky Law, a journalist who has reported on health care for 25 years, sets out in this important book the story of a monster that has grown in our midst so quickly we have yet to grasp the implications. During a single human life span the international pharmas have expanded from an industry struggling to market drugs into a global combine of colossal power and wealth. It now delivers better financial returns than all other industries. The figures are astounding. Ten drugs earned $48.3 billion in 2003.

    Top drugs such as Lipitor (prescribed to lower cholesterol) can earn tens of billions of dollars per annum — one product accounting for more money in one year than most companies earn in a lifetime. The pharmaceutical companies make such enormous profits, Law says, that the whole business has a momentum of its own that seems impossible to check. As a result the very reason for the existence of the industry needs a fresh evaluation. What is its aim?

    In offering an answer, Law, with scrupulous objectivity, does not blame only the pharmas. She writes: “The problem has been that the regulators and the industry that they are paid to regulate have been able to coexist rather too cosily for too long. In the case of the UK, there are historic reasons why commercial issues have become so entangled with public health, but in fact all countries are driven by political agendas that have always put greater weight on the creation of wealth than health.” So it is no good relying on the government either to hold the industry in check or make certain that its drugs provide us with value for money.

    The truth is that the industry is left to its own devices, what it researches is driven by market forces and the result is that only a minority of new drugs offers any clinical advantage over old ones. But what about science? Where are all our objective, independent scientists? Why haven’t they noticed all this and blown the whistle? Reading this book gives you the impression that nowadays it is hard to find a scientist who does not work for a drug company.

    Law writes, “Just finding experts with absolutely no connection with a drug to sit on the regulatory panels that decide whether a drug should get a licence is not easy.” She writes that this is a possible explanation for what happened in the Vioxx scandal in America. Trumpeted as a brilliant new painkiller, Vioxx turned out to cause heart attacks and strokes. An official of the Food and Drug Administration (FDA) told a US Senate hearing in 2004 that his agency’s approval of Vioxx had led to “the single greatest drug-safety catastrophe in the history of this country or the history of the world”.

    Another FDA officer estimated that 28,000 Americans had had heart attacks and strokes as a result of taking Vioxx while he was arguing with his superiors about its risks. Yet the final twist, Law points out, came when a 32-member committee of the FDA voted 17-15 to allow the drug back on the market. Despite the book’s devastating indictments, the final picture is not without hope. Law points out that the human race can survive perfectly well without an endless supply of new drugs but the pharmaceutical industry cannot. So there is the possibility of a transfer of power. It seems to me that we might have subconsciously realised this. Otherwise how to explain the fact that in Britain we do not bother to take at least half the drugs prescribed for us?

    They go gently out of date in the bathroom cabinet. But a radical change would require a decision by us to play a bigger role in our own health care. Thanks to the internet we are already better informed about illnesses and possible treatments than ever before.

    Law says we now need to move away from the medicalisation of society, the belief that every problem requires a medical solution, and break the pharmas’ stranglehold by insisting that our leaders treat public health separately from the commercial interests of the pharmaceutical industry.

    We need to seize back control of our medical destinies, and this book’s great strength is that it inspires us to do just that.

    http://www.timesonline.co.uk/article/0,,2102-2029416,00.html

    Copyright 2006 Times Newspapers Ltd.

    Also by Philip Knightely: Khaleej Times: Bitter pill - The big business of Big Pharma By Philip Knightely 11 February 2006

    BBC Radio 4 Start the Week with Andrew Marr January 16 2006

    Voice of the Listener and Viewer have voted Start the Week Best Radio Programme in their 2005 Awards. Start the Week also won in 1994 and is only the second programme to win the award twice.Andrew Marr has also won the Best Contributor To Radio Award.

    JACKY LAW was one of the guests on 16 January 2006, together with actor, director, producer and writer for radio and television, ARMANDO IANNUCCI, former Secretary of State for Education ESTELLE MORRIS, and authorMICHAEL MOORCOCK.

    Her book, Big Pharma, looks into the big business of the pharmaceutical industry and how this influences what we get prescribed. Medicines contribute hugely to the health of the nation, and most of us would take the pills if our doctor prescribed them, but what is the background behind these medicines? Who says they are safe? Who sets the price? And who decides the development of new drugs, and for what illnesses?


    http://www.bbc.co.uk/radio4/factual/starttheweek_20060116.shtml

    The Fools Gold That Heals - Guardian Book Extract

    Saturday January 14, 2006 Guardian

    The fool's gold that heals

    Drug companies are the most profitable businesses in the world - ever seeking new diseases for which they can provide new 'miracle' medicines. But the fact is, Jacky Law reports, a simple sugar pill can often be just as effective

    "You can get away with a lot in the medicines business, but there is one basic requirement - a drug should do you some good. This has to be proved in at least two controlled studies. These large-scale clinical trials often cost millions of dollars and must consist of at least two arms: one of people who are given the test drug and a second group who act as a means of comparison.

    This second group is given a placebo, a sugar pill with no powers other than those evoked through the power of suggestion. The placebo effect shows what the mind and body are capable of achieving in the absence of real drugs but with the expectation of benefit. Potential participants in a trial are filtered through various entry criteria such as age, severity of disease and so on, and then selected at random. It can be conducted in a single hospital or in a network of clinical centres around the world. It can last weeks, months or years. The most important thing is that neither doctor nor patient knows who is taking the drug and who is not.

    The placebo, despite containing no active ingredient, often proves a surprisingly strong contender. Its performance in clinical trial after clinical trial shows patients inherently possess vast amounts of untapped healing power. They want to be well so much, their bodies respond to the mere expectation that they will be.

    These hopes are easily exploited by pharmaceutical companies when they want to extend the reach of a drug, increasing the number of conditions the single drug is used to treat. In this sense medicines are packaged science. The package, or label, plus what the doctor tells them, is all most people get to know of the drug and what its expected effects will be.

    Where some antidepressant drugs are concerned, the label can say almost whatever you want it to say. It could be for painful periods, for depression, to stop smoking, to become more engaged in the world, for panic attacks, irritable bowels, incontinence, shyness - for virtually anything that has some kind of anxiety at its root.

    The active ingredient can be the same, but its effect will depend on what it is being tested for. If it has been shown in a trial to treat irritable bowels or help smoking cessation, and it has been approved by the regulators for that indication, then that is what it will say on the label. And the drugs work according to what the label says, what the doctor says, and what we believe. Our minds and bodies respond, in other words, to what we are told the drug will do.

    GlaxoSmithKline's Zyban for giving up smoking, for example, is a long-acting form of Wellbutrin for depression by another name. And the antidepressant, Zispin, is also marketed for sleeping disorders, one of the top symptoms in diagnosing depression. Many lifestyle drugs are prescribed under a number of different names. Different studies are done to get different licensing data to get them known as different drugs so they can operate in different therapeutic markets.

    What makes a smoker more likely to kick their habit on Zyban than on the identical drug posing as an antidepressant is the fact that this is what the doctor says, and what the data from clinical studies corroborates. Such drugs are a triumph of branding - a triumph of making maximum use and maximum profit from a single compound. Packages of symptoms that might otherwise be interpreted as fairly normal in the kind of fast, attention-deficit world we live in, become new diseases and new opportunities for medication.

    Few new drugs are being produced, yet the amount spent on drugs steadily soars. And it is not only drug companies who benefit from the widespread belief that we could all be a lot healthier than we are. Most natural forms of healing are thought to work largely because they evoke a placebo response through the trust patients have in the treatment, the practitioner, or both.

    Pharmaceutical companies stand accused of actively trying to get people to internalise morbid messages that suggest they are ill. "The way to sell drugs is to sell psychiatric sickness. If you are Paxil and you are the only manufacturer who has the drug for social anxiety disorder, it's in your interest to broaden the category as far as possible and make the borders as fuzzy as possible," said US bioethicist Carl Elliott.

    Paxil's product director, Barry Brand, told the journal Advertising Age that the company GlaxoSmithKline had been largely successful in this respect. "Every marketer's dream is to find an unidentified or unknown market and develop it. That's what we were able to do with social anxiety disorder."

    As more research dollars are poured into the workings of our mind, a rapidly growing range of conditions is being developed that, ostensibly at least, can be treated pharmacologically.

    Diagnosing mental illness is difficult: what appears to one psychiatrist to be depression might be diagnosed by another as schizophrenia, manic depression, or just ordinary grief. Meanwhile, the number of officially recognised disorders soars. In the American Psychiatric Association's manual of 1980, 106 disorders were listed; the figure had risen to 300 in the 1994 edition. The new categories include attention-deficit disorder (ADD), antisocial personality disorder (impulsivity or failure to plan ahead), dissociative fugue (an overwhelming urge to travel away from home or one's customary place of work) and many other things most of us will have experienced at some time or other.

    Companies have been very clever at peppering the medical literature with ghost-written editorials and review papers that promote off-label use of their drugs. In the words of Dr Jay Pomerantz, of Harvard University: "If what we are seeing is a pattern of widespread antidepressant prescribing for subsyndromal, amorphous patient complaints, it suggests antidepressants have become the modern-day sugar pill, or placebo... [if this is the case] taxpayers are paying the pharmaceutical industry a mighty high price for fool's gold."

    The placebo effect is directly related to trust. Good doctors, who have the complete confidence of their patients, exert a placebo effect in how they listen and their general ability to convince patients they are being taken seriously. If patients believe a medicine will work, so the placebo effect of that drug is enhanced. The US writer Norman Cousins, who famously recovered from an incurable disease himself and wrote the book Anatomy Of An Illness As Perceived By The Patient, cites an experiment into the role of doctors.

    "Patients with bleeding ulcers were divided into two groups," he says. Members of the first group were informed by the doctor that a new drug had just been developed that would undoubtedly produce relief. The second group was told by nurses that a new experimental drug would be administered, but that very little was known about its effects. Of the people in the first group, 70% received sufficient relief from their ulcers. Only 25% of the patients in the second group experienced similar benefit. Both groups had been given the identical "drug" - a placebo.

    Cousins also cites the late Dr Henry K Beecher, an anaesthesiologist at Harvard, who analysed the results of 15 studies involving 1,082 patients. He discovered that across the broad spectrum of these tests, more than a third (35%) of the patients consistently experienced "satisfactory relief" when placebos were used instead of regular medication. The medical problems included severe post-operative wound pain, seasickness, headaches, coughs and anxiety. Other biological processes known to be affected by placebos include rheumatoid and degenerative arthritis, blood-cell count, respiratory rates, vasomotor function, peptic ulcers, hypertension, hay fever and spontaneous remission of warts.

    Ted Kaptchuk, who heads a placebo working group at Harvard Medical School, is leading a trial involving a drug that treats an intractable, common stomach disorder. Half the patients are treated with the drug by a doctor who is positive about the medicine and who listens attentively to their account of how the symptoms manifest. The others are treated by a doctor who gives a fairly matter-of-fact presentation of the medicine before leaving the room. The idea is to demonstrate the worth not of drugs but of doctors.

    How the placebo works is the subject of endless discussion. American medical writer Berton Rouché, in an article in the New Yorker magazine back in 1960, said the placebo derives its power from the "infinite capacity of the human mind for self-deception". Others believe the placebo is powerful not because it tricks the mind of the patient but because, as Cousins says, it translates the will to live into a physical reality. "The fact that a placebo will have no physiological effect if the patient knows it is a placebo only confirms something about the capacity of the human body to transform hope into tangible and essential biochemical change."

    Consider the dilemma facing the pharmaceutical industry. In clinical trials for depression, people taking Prozac improved on average by 8.3 percentage points on a standard scale that quantifies the severity of the disease. Those on the placebo arm, however, also did well, improving by 7.34 points. People on Paxil/Seroxat improved by 9.88 points, and on the placebo arm by 6.67 points. The scores for Zoloft were 9.96 (placebo, 7.93); Effexor, 11.54 (placebo, 8.38); Celexa, 9.69 (placebo, 7.71).

    The relatively poor show of the antidepressants is replicated in study after study. A couple of years ago, for example, a $6m study found the herbal remedy St John's wort was less effective than a placebo, apparently as a vindication of conventional medicine. While the herb had managed to help only 24% of cases of moderate to severe depression, the placebo scored 32%. It later emerged that Zoloft was also part of the trial and had helped 25%.

    It is ironic that the areas of medicine where the placebo effect has been shown to be most powerful - pain and depression - are precisely the areas at the centre of the recent regulatory storms. And the irony shows succinctly how self-defeating healthcare systems can be if trust is allowed to slip away. The placebo effect works on trust. But the revelations about the new wave of antidepressants, SSRIs - that it was more difficult to come off them than anticipated, and that they made some people feel suicidal - together with the withdrawal of the painkiller Vioxx, did nothing to improve that trust.

    The central issue remains whether drugs are always the best solution. Pharmaceutical companies are always pushing for a more direct relationship with the public, where they paint a picture of the consumer as king. They may have the regulators on their back, the science against them, patents expiring, everyone screaming for lower prices, but the zeitgeist is with them: it is not hard to convince people that it is more of a crime to suffer in silence from a condition than to take something that can cure it instantly.

    If patients really were king, they would resist the medicalisation of society and query the terms of reference, for instance, of studies that suggest 80% of people can expect to suffer depression at some time in their lives, or that 43% of women suffer an unhealthy response when having sex. Instead, as with the effect of pharma marketing on doctors, there is a sort of drip effect.

    Even if people genuinely try to ignore such commercially inspired drivel, some of it gets through. Journalist Ray Moynihan located the original study detailed in the Journal of the American Medical Association which showed that 43% of women suffered from female sexual dysfunction (FSD); he found the authors had close links to Pfizer, which was testing Viagra in women at the time. He also found 1,500 women, aged between 18 and 59, had been asked if they had experienced any of seven problems for two months or more over the previous year. One was a lack of desire for sex and another anxiety about sexual performance. No questions were asked about the length of their relationships - a major factor in many people's sex lives - nor about what else the women did, how many children they were looking after, and so on.

    The results of that study were widely quoted in the press. In this way, medicine enters the most intimate areas of our lives, despite evidence that our bodies respond in ways we want them to without the help of drugs. Pfizer, for example, did every-thing it could to show Viagra could work in women. It carried out several large-scale trials in women with apparent FSD only to find the women on Viagra responded but those on placebo responded more.

    The drugs don't work.

    The global spend on pharmaceuticals has risen 25-fold over the past three decades, from $20bn in 1972 to more than $500bn in 2004.

    '[In 2002] the combined profits for the 10 drug companies in the Fortune 500 ($35.9bn) were more than the profits for the other 490 businesses put together ($33.7bn),' Dr Marcia Angell writes in her book The Truth About The Drug Companies. The breakdown of pharma finances for 2003 is: 14% on research and development, 17% on profits, 31% on marketing and admin, the rest on manufacturing and distribution.

    • The pharmaceutical industry is reckoned to spend more than $5.5bn to promote drugs to doctors in the US each year - more than all US medical schools spend on educating medical students.

    • Dr David Graham of the FDA told a US Senate hearing in October 2004 that his agency's approval of Vioxx led to the 'single greatest drug safety catastrophe in the history of this country or the world'. Vioxx is a painkiller introduced with much fanfare because it avoided the side-effects of aspirin and ibuprofen, which occasionally result in intestinal bleeding. Merck spent more than $150m a year on its Vioxx ads in the US, more than was spent advertising Pepsi-Cola or Budweiser. By the time Vioxx was withdrawn in September 2004 - because it had been shown to double the chances of heart attack or stroke - it was earning $2.5bn. Graham said 28,000 Americans suffered ill effects from it while the FDA argued about what action to take. Since then Vioxx has been cleared for use in the US, subject to caveats and warnings.

    • The Pharmaceutical Journal guestimated that half of all medicines prescribed in the UK are not taken. The UK industry's association puts the figure at 80%.

    • For decades, stomach ulcers were attributed to gastric acidity, stress, smoking, alcohol and genetic disposition, and treated with antacids. Yet the bacterium that causes ulcers had been identified in 1982 and can be treated with antibiotics. Similarly, Paul W Ewald argues in his book Plague Time, thousands of women probably suffered and died 'because cervical cancer was treated as bad luck rather than a preventable sexually transmitted disease'.

    • 'Metabolic syndrome' covers a cluster of common metabolic disorders, such as abnormal lipid levels, obesity and high blood pressure. It is now said to be approaching epidemic levels, with 115 million sufferers. Such a syndrome was not even recognised before 1988.

    This is an edited extract from Big Pharma, by Jacky Law, to be published on February 9 by Constable & Robinson at £12.99.

    Guardian Unlimited © Guardian Newspapers Limited 2006

    http://books.guardian.co.uk/extracts/story/0,,1686011,00.html

    Constable & Robinson publish Big Pharma

    Lifting the lid on the world of the largest pharmaceutical companies to reveal the real challenges facing modern health care

    For all the benefits they bring, the pharmaceutical industry's biggest companies, headed by Pfizer, Sanofi-Aventis and Glaxo SmithKline, increasingly face a conflict between the goals of corporate wealth and public health.

    In a broad and independent analysis of the modern healthcare system, Jacky Law shows how a small number of corporations have come to dominate the agenda in Britain and America. She reveals a system in which the relentless pursuit of profit is crowding out the public good. Effective regulators are under intense pressure from corporate lobbies, and companies spend more money on marketing than on research and development. The cost of new drugs rises relentlessly while the number of original new products declines.

    Every year we pay more money for our drugs. But just how much healthier are we? And is there any limit to what we will pay?

    The author reveals a world where market considerations, not medical need, is determining the research agenda. She points to a future where the public and the medical profession could once again have a voice in the kind of healthcare we want -- and the healthcare we pay for.

    Price £12.99 Format Paperback Pub Date Jan 06 Imprint Constable ISBN 1 84529 139 5 Category Current Affairs Foreign Rights Constable & Robinson Markets Available

    http://www.constablerobinson.com/edition.aspx?id=15760