The Multinational Pharmaceutical Giants Exposed

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The Multinational Pharmaceutical Giants Exposed

The Rebranding of a Disease

Pharmaceutical Super-profits

Unease on Industry's Role in Hypertension Debate

Big Pharma: politically influential pharmaceutical industry; the pharmaceutical industry seen as influential in the political and commercial spheres [definition: MSN Encarta]

The multinational pharmaceutical companies who are behind the criminal exploitation of people’s ill health across the world have been exposed in recent findings as refusing to give the true studies and analysis of their drugs. In particular, they do not present the negative effect they may have on human beings who have been prescribed such drugs.

Reports which appeared on February 26, relating to findings that major anti-depressant drugs do not work, have exposed the lack of regulation and accountability of the multinational pharmaceutical industry which does not reveal the actual findings of clinical trials on its products. However, this is only the latest of the exposures dating back many years. The drug companies such as GlaxoSmithKline are now exposed in the fact that they are withholding important data on pharmaceuticals. This is a crime added to that of withholding vital drugs to the poor throughout the world who cannot afford their staggering prices.

Tim Kendall, deputy director of the Royal College of Psychiatrists’ research unit, who is head of the National Collaborating Centre for Nice (National Institute for Clinical Excellence) guidelines on mental health, said that it has proved impossible to have access to unpublished trials in the past.

He stated: "The companies have the data but will not release it. When we were drawing up the guidelines on prescribing anti-depressants to children (in 2004) we wrote to all the companies asking for it but they said no. The government pledged in its manifesto to compel the drug companies to give access to their data but that commitment has not been met."

The Labour government now it is in power talks of a voluntary approach that would not compel the drug companies to reveal their studies. The government as executive of the monopolies will not hold the multinational pharmaceutical industry to account, as it is not in the narrow interests of the ruling elite and its capital-centred outlook.

The pharmaceutical industry is being condemned by experts in medical research who criticise the stranglehold exerted by the multinational companies over clinical trials. This stranglehold produces biased results, under-reporting of negative findings and selective publication driven by the market, which was worth £10.1 billion in the UK in 2006, amounting to 11% of total NHS costs.

The question posing itself is the necessity for a modern enlightened health service that bases its care and treatment on advanced human principles and so is centred on the human being. What must be demanded of a new health service is to end the monopoly control where the exploitation of people’s ill health is used to pay the rich. This new health service must be preventative and holistic in its essence, and not a free for all for the multinational companies that want to make a huge profit at the expense of the working class and people. Health care must be the responsibility of the society. The future of the NHS must be safeguarded against the exploitation by Big Pharma!

(see the following link for a table of mergers and takeovers within the pharmaceutical industry: http://www.rpsgb.org.uk/pdfs/mergers.pdf)

Jerome Burne, New Statesman, 11 March, 2002

Should we trust the scientific data on the effects of drugs? Not if the case of depression, for which pharmaceutical companies found a new definition, is anything to go by. Jerome Burne reports

If the directors of drug companies are in the habit of taking their own medicines, then consumption of anti-depressants in their boardrooms should have soared last month. Not least to show solidarity in the face of growing concerns that Prozac-type anti-depression drugs, one of the biggest pharmaceutical success stories of the past decade, may be not only dangerous to some, but also addictive.

The magazine Health Which? came out with a warning that patients being offered anti-depressants were often not told "about issues such as withdrawal problems or . . . a possible risk of increased suicidal behaviour", and the Royal College of Psychiatrists issued new guidelines, saying that only 50 per cent of patients would be "much improved" after taking anti-depressants, which is little better than a placebo. Meanwhile, in the United States, the issue of addiction was highlighted when the Food and Drug Administration ordered the company GlaxoSmithKline to warn doctors prescribing the drug Seroxat about the possibility of dependency. The company was also found in breach of the industry code by describing problems with withdrawal as "very rare".

All of this came in the wake of a court case last June, brought by the family of a man who, a few days after being put on the drug for sleeping problems, had shot his daughter, his grandchildren and then himself. The court agreed with the family's claim that Seroxat (one of a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs) had contributed to his behaviour, and awarded them $6.4m. This was the second case linking SSRIs with suicide to come to court, but more than 200 have been settled out of court.

What makes this all the more alarming is that the drugs involved are so widely used – prescriptions for all SSRIs in the UK run at about 10 million. They are increasingly prescribed for a wide variety of conditions, such as skin complaints, pre- menstrual tension, weight loss and attention-deficit disorder. But it also raises the more important and wider question: can we trust the drug companies? Or is there a strong possibility that their business practices could leave both doctors and patients with no way of telling just how safe or effective our medications are?

When it comes to spin, the drug companies make the government look clumsy and amateurish. At the heart of the worries over SSRIs is the growing belief that the drug companies have been less than honest in their account of the risks involved. But it is not just SSRIs that are given a positive gloss when the evidence points the other way. In January, for instance, Swiss prosecutors began a criminal inquiry into the pharmaceutical giant Bayer AG, "on suspicion of fraud and grievous bodily damage", following the recall last year of the cholesterol- lowering drug cerivastatin (otherwise known as Lipobay in Europe and Baycol in the US). The prosecutors are accusing Bayer of suppressing vital information about the drug's potentially fatal interaction with another drug, which has been linked to more than 50 deaths.

Could the drug companies do such a thing? The editors of the world's top 11 medical journals, including the Lancet, the British Medical Journal and the New England Journal of Medicine, certainly think so. Last September, the International Committee of Medical Journal Editors issued a joint statement calling for more openness in the way drug companies report their results and less readiness to hide unfavourable ones. The editors declared that they will now "require authors to attest that they had full access to all of the data in [a] study and . . . [to] take complete responsibility for the integrity of the data and the accuracy of the data analysis".

The point about having "full access to all of the data" is crucial, because it lies at the root of how science works. Only if they can look at the raw data are other scientists able to judge how reasonable is the interpretation. But all too often, the results from drug trials are presented in the form of tables, and the drug companies refuse access to the raw data on the grounds that it is commercially sensitive.

However, the concerns of the journal editors on this point were clearly not enough. In February, the UK's National Institute of Clinical Excellence (Nice) claimed that "drug companies have successfully withheld important data". Gauging the efficacy of a drug is fraught with problems, declared Dr Iain Chalmers of the Cochrane Centre, an organisation set up to evaluate the efficacy of medical treatments, "because negative results are rarely published in medical journals".

The moral vacuum that results from constant spinning is threatening to suck in not just the academics who are paid to do the work for drug companies, but the whole process of scientific medicine. In an article last September entitled "Dancing with the porcupine", the Canadian Medical Association Journal attempted to set out some principles that ought to apply when pharmaceutical companies are funding academics. The authors start by recognising that such alliances are inherently tricky: "The duty of the universities is to seek the truth. The duty of the pharmaceutical companies is to make money." But, and this is the important bit, "if either abandons its fundamental mission, it ultimately fails". A broke drug company or a discredited academic is no use to anyone.

The attempt to hammer out some sort of guidelines was set against the background of at least two highly publicised Canadian cases where drug companies had used "intimidating tactics" that had "profoundly affected" researchers' lives. One involved a lawsuit by Bristol-Myers Squibb against the Canadian Co-ordinating Office for Health Technology Assessment to suppress a report on the cholesterol-lowering drugs statins. The other was the legal threat by AstraZeneca against a researcher at Ontario's McMaster University for her review of medications for stomach disorders.

Even if matters don't get as far as the courts, "industry funding creates an incentive to promote the positive and suppress the negative", says the journal. An example is the "landmark article" showing that industry-sponsored research into certain heart drugs is more likely to be supportive of their use than is independently funded research. The conclusion argues for the drawing up of some sort of industry/university contract containing clauses giving academics the right to "disclose potentially harmful clinical effects immediately", for a surcharge on contracts to fund a regulatory body, for the setting up of an ombudsman, and so on.

All very well and good, but getting regulatory bodies to respond to concerns about some drugs can be hard work. That, at least, has been the experience of the psychiatrist Dr David Healy who, since 1999, has been engaged in extensive correspondence with the UK's Medicines Control Agency (MCA) over the links between SSRIs, suicide and addiction. Their exchange of letters now runs to more than 100 pages, with the majority of that coming from Healy. As of last month, the agency's position is that there is no cause for concern and that all the warnings that are needed are in place.

What makes Healy's campaign of particular interest is, first, that he's no maverick, driven by a belief in herbs or the healing power of madness. He is a mainstream biological psychiatrist and director of the North Wales Department of Psychological Medicine in Bangor, he has written a highly acclaimed history of anti-depressants – The Anti-depressant Era, published by Harvard University Press – and he is the author of more than 100 scientific papers. But he is concerned that patients and the profession are not being told the truth about the risks.

His campaign also gains added weight from his experience as an expert witness in two American court cases involving suicide and SSRIs. As a result, he has seen previously unpublished data on trials carried out by the drug companies on healthy volunteers. His analysis of the secret data, the sort that drug companies usually refuse to release, shows that about 25 per cent of healthy volunteers given the drug had some sort of unpleasant psychological reaction. "That suggests that the likelihood of someone committing suicide during their first month of treatment with Prozac is ten times greater than if they were untreated," he says. "That is a level of risk approaching that of a smoker's likelihood of developing lung cancer."

This suggests an astonishing gap between what the drug companies say publicly and what their own data shows. As a striking illustration of this gap between secret and public knowledge, Healy is fond of quoting a story from an American newspaper, the Boston Globe, which appeared in May 2000. It concerned a new form of Prozac, known as R-fluoxetine, which had been patented in 1993 (US patent no 5,708,035) and which Eli Lilly planned to market when the existing patent ran out in 2002. A patent application requires that you say why your new version is an improvement. So what were the benefits of R-fluoxetine? "It will not produce several existing side effects, including akathsia [agitation], suicidal thoughts and self-mutilation . . . one of its [Prozac's] more significant side effects" – precisely the side effects that the company had been denying for a decade.

But such information has not set any alarm bells ringing at the Medicines Control Agency. In September 2000, months after the revelation about the patent for a new, non-suicidal Prozac, the agency put out a fresh statement saying that there was no evidence of a link between suicide and SSRIs. Then, in the wake of the large damages award last June, Healy sent yet another long letter detailing his concerns, based on an analysis of the secret data. It was December before the agency replied with a letter which basically said that all was well, although the issue was being kept under review.

The commercial spinning of results and the apparent indifference of the regulatory agencies are bad enough, but it is Healy's belief that something even more insidious has been going on – something that demonstrates even more vividly the virtually unfettered power of the drug companies to spin not just results, but the way both patients and physicians think about depression.

We are all in favour of marketing these days – political parties, magazines, charities are all regularly rebranded – but is it acceptable to rebrand a disease? We are not talking about a campaign to bring a disease or a condition out of the closet – "I'm incontinent and proud of it". Healy's claim is that there has been a deliberate campaign by drug companies to change our image of depression for the sake of sales of anti-depressant drugs.

Fifteen years ago, depression was viewed as a severe mental condition that often required hospitalisation, while anxiety, sadness, worries about social situations and feeling tired all the time were considered milder conditions and treated with tranquillisers such as Valium. With the arrival of SSRIs, tranquillisers fell heavily out of favour because they had been shown to be addictive. In their place were SSRIs – safe, non-addictive and effective. The one psychopharmacological fact everyone became familiar with was that serotonin is the brain's feel-good chemical: too little of it and you feel blue, worried, down, depressed. SSRIs increase the amount of serotonin available in the brain.

"The only problem with this story," Healy told an audience at the Institute of Psychiatry in London in February, "is that there are no studies proving that serotonin levels have anything to do with depression." He can speak with some authority on this because, before moving to Bangor, he was researching serotonin receptors at the Department of Psychiatry at Addenbrooke's, Cambridge. "SSRIs can certainly have an effect on mood, and for some people they are very effective. But we don't really understand how they work, and it is not by directly changing serotonin levels."

When SSRIs were launched, they were described as anti- depressants to distinguish them from the addictive tranquillisers. But there was a marketing problem. They weren't actually effective in treating classic depression. What was needed was for them to become the drug of choice for the people previously given tranquillisers. The key to this was the notion that low levels of serotonin were a problem that could be treated as a deficiency disorder, on a par with having low levels of a vitamin or mineral. That old-fashioned benzodiazepines, such as Valium, had dealt with these anxiety disorders by affecting an entirely different brain chemical, known as gamma-aminobutyric acid (GABA), was simply ignored.

Obviously there is an overlap between anxiety and depression, and maybe some redrawing of the boundaries is appropriate, but the point is that what has happened here has nothing to do with research. In fact, there is good evidence that much of what passes for scientific research on SSRIs by the drug companies is nothing of the sort because of the lack of access to raw data. Healy's solution to this problem is more democratic than setting up yet more regulatory committees. He wants to involve a group of people not often considered in these debates – the patients. Or, to be more precise, those patients who volunteer to take part in the drug companies' clinical trials. At the moment, they have no control over the results of the treatments they submit themselves to, often for free. So instead of contracts between drug companies and universities, how about one between the volunteers and the company running the trial? In return for participating for free, subjects should, at the very least, be given the right to see the results and probably also the right to have some say about the purpose of the trial. That way, a number of studies might get done that would actually be in the patients' interests rather than just the drug companies'.

For instance, even though the suicide issue has been discussed since the early 1990s, there has never been a trial specifically to test it. Nor have there been any studies to distinguish which patients benefit from which anti-depressants. Healy's own studies involving giving SSRIs to healthy volunteers have found that certain personality types – as established by questionnaire – seemed to do better than others on them. Teasing out those differences could make prescribing a far less hit-and-miss affair than it is at present. The recently publicised issues of dependency and withdrawal have not been tested properly either, because the companies have always denied that there is a problem.

Making patients partners in the trials, rather than just clinical fodder, could restore a genuine spirit of scientific inquiry. The result could be far more accurate information about the safety and effectiveness of our drugs than the spun results on which both doctors and patients have to rely at the moment.

By Colin Brown, The Independent, Wednesday, 21 February 2007

The drugs industry has been accused of "ripping off" the NHS after a report by the Office of Fair Trading found excessive profits on brand-name drugs costing the health service £8bn.

Some drugs now prescribed in large volumes are up to 10 times more expensive than substitute treatments that deliver very similar benefits to patients, the OFT said.

The watchdog said reforming the existing Pharmaceutical Price Regulation Scheme (PPRS), which fixes the price the NHS pays for its drugs so that the cost of drugs reflects their clinical and therapeutic value to patients, could save the NHS more than £500m.

"We have identified hundreds of millions of pounds per year that could be used more cost-effectively under value-based pricing, allowing patients greater access to drugs and other healthcare benefits they are currently being denied. In short, the same level of expenditure could be used to produce greater benefits for patients," said the OFT.

Savings of £352m and £28m could be made on atorvastatins and rosuvastatins, which are used to lower cholesterol. Countries such as Sweden, Australia and Canada have already introduced successful value-based pricing systems.

Liberal Democrat health spokesman Norman Lamb said: "Wasting hundreds of millions of pounds on branded medicines amounts to a massive hidden subsidy to drug companies. Trusts around the country are in a position where they simply cannot afford to pay for many drugs. People with real needs are being denied the treatments that could improve their lives."

He added: "It seems ridiculous that drug companies get a set deal on pricing, which bears little relation to how effective treatments are for patients. This Government has a poor track record at securing value for money in the NHS. The Department of Health must get far tougher with the major drug companies."

Geoff Martin, the head of campaigns at Health Emergency, a pressure group, said: "The OFT report shows that hundreds of millions of pounds a year are being ripped off from the NHS on expensive, name-brand drugs. That money would be enough to wipe out NHS deficits... and would stop the growing tide of job losses and service cuts."

The total NHS drugs bill has grown by 7 per cent a year. In 2005 it was £11bn, of which £8bn went on brand-name drugs, and £3bn on generic drugs. The Department of Health claims that 5 per cent of the increase is due to more prescriptions being issued.

Ministers said they were studying the report. Kevin Barron, Labour chairman of the Commons Health Select Committee, warned that the changes could hit a successful British industry. "We should make sure we don't throw the baby out with the bath water," he said.

Andrew Lansley, the shadow Health Secretary, said: "I am glad the OFT has supported ideas I have put to ministers about the NHS and drug companies sharing the risks and benefits of new medicines as they are brought into clinical use." But he also warned against damaging the industry by undermining the profits it needs to bring new drugs to market.

By Stephanie Saul, The New York Times, May 20, 2006

Three pharmaceutical companies donated $700,000 to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure.

The same three companies – Merck, Novartis and Sankyo – also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs.

The seven dinners at Ruth's Chris Steak Houses around the country are just one example of why the small medical society, the American Society of Hypertension, has been in the midst of a dispute over the influence of drug industry money.

"This is about the monetarisation of medicine," Dr Michael H Alderman, a past president of the organisation, said in a recent interview.

The dinners promoting a new definition of high blood pressure illustrate connections – among the pharmaceutical industry, academic physicians and societies that formulate opinion – that can ultimately affect patient treatment. And the dispute within the society reflects a growing unease that industry money is influencing scientific discourse in medical societies and elsewhere.

At a recent speech before another society, the American College of Cardiology, its new president, Dr Steven E Nissen of the Cleveland Clinic, suggested that the medical profession had become addicted to industry money just as the nation was addicted to foreign oil.

After months of controversy within the American Society of Hypertension that included accusations of industry influence, the society's president, Dr Thomas D Giles, said yesterday that the group's leadership would be required to disclose more details about the money they receive from industry.

Dr Giles said the organisation had always maintained a firewall between its activities and industry funding. "We don't take money that has strings attached to it," Dr Giles said, emphasising that its industry grants are not earmarked for any specific purpose.

The added disclosure had been sought by a board member, Jean E Sealey, a biochemist and a longtime blood pressure researcher affiliated with Weill Medical College of Cornell University, who was among those also involved in a leadership struggle within the organisation.

Dr Alderman, a professor of medicine and epidemiology at the Albert Einstein College of Medicine in the Bronx, is one of several doctors who withdrew from a group formed by the society to write the new blood pressure definition.

He complained that the definition was derived from a hodgepodge of opinions not supported by hard science, and also questioned whether the society of 1,600 could insulate itself from the drug company donations it used to operate.

Controlling blood pressure has long been a mainstay of the pharmaceutical industry. About 65 million Americans have high blood pressure under the current definition and they help fuel a $17 billion annual market in drugs for hypertension. But another 59 million people are on the borderline, and many doctors believe the new definition of hypertension could make drugs a standard treatment for many of them, drastically expanding the potential drug market.

Dr Giles of Louisiana State University's medical school in New Orleans was the driving force behind the new definition. The work of the group that developed it was financed by $75,000 in unrestricted drug industry grants from Merck, Novartis and Sankyo, according to Susan Rood, a spokeswoman for the Society of Hypertension. Ms. Rood also confirmed that the dinners were financed by $700,000 in grants, also unrestricted, from the same companies. The new definition that resulted was written by some of the leading experts in blood pressure medicine.

Pre-hypertension has been considered a blood pressure reading of 120/80 to 139/89, according to guidelines developed by a National Institutes of Health panel, which first identified the pre-hypertension category in 2003. Currently, pre-hypertension is generally not treated with drugs.

The new definition proposes assigning some of the people with pre-hypertension to a new category called Stage 1 hypertension. Hypertension is currently defined as blood pressure readings of 140/90 and above.

Dr Giles estimated that the proposed definition would move half of those whose blood pressure readings are currently considered pre-hypertension to the Stage 1 hypertension category.

That determination would be based not just on their blood pressure readings, but also on other risk factors.

The proposed definition makes no specific treatment recommendations. But some specialists who have read the proposed definition say it is a short step from labelling someone with high blood pressure to prescribing pills. And they predict that if the new definition is embraced, it will expand the use of medications.

Dr Curt D. Furberg, a professor of public health science at Wake Forest University, who was among those who withdrew from the writing group, citing concerns that its work was not evidence-based, said, "The industry wants to sell drugs and to as many people as possible."

But Dr Giles said it was possible that the use of medication could actually contract under the new definition, with some doctors recommending lifestyle modifications rather than medication. And he said industry money or influence did not play a role in the proposed definition, which he said reflected a concern that too many people with diagnoses of pre-hypertension ended up having strokes.

"I will tell you that if you've ever sat there and watched patients in the prime of life get a stroke or a heart attack, it's heart-wrenching," Dr Giles said last week.

The recommendations by Dr Giles and his group are considered influential in the evolving thinking over what constitutes high blood pressure. In addition, the discussion about whose blood pressure should be treated is also being driven by a new study that concluded that a drug called Atacand by AstraZeneca could reduce the risk that people with pre-hypertension will develop hypertension.

Treating pre-hypertension was among the topics at a meeting this week of the society at the New York Hilton. The meeting ends today.

The debate is in some ways similar to questions about changing thresholds for defining high cholesterol, diabetes and obesity – areas where accusations have been levelled in the past that the pharmaceutical industry has tried to exert influence.

"All of this has got the ring of seeming to be of great benefit to the pharmaceutical industry without clear evidence that it's going to be the same benefit to the public," Dr Alderman said recently

In statements, spokeswomen for Merck and Novartis confirmed that their companies had helped finance the society's work, but said that they had no influence over the outcome of the new definition or the content of the dinner briefings held last fall in seven cities.

Sankyo did not return calls seeking comment.

Of the seven doctors who wrote the proposed new definition, six have said that they served as consultants and speakers for pharmaceutical companies that make blood pressure medications. The seventh is a consultant and stockholder in a company that markets a diagnostic method to measure damage to blood vessels.

Such industry affiliations are not unusual among prominent doctors at academic research centres. And for years, the American Society of Hypertension, known as ASH, has operated with industry support.

But some members of ASH have become vocal critics of the influence wielded by the drug industry, including the person who was next in line to become the society's president, Dr Sealey, who has been embroiled in a longstanding dispute with the organisation's current leadership over that and other issues.

"The truth of the matter is that we have many members who are leaders in our society who are making well into the six figures from their pharmaceutical-company-supported activities," Dr Sealey, a research biochemist and physiologist, said in an interview two weeks ago.

But many members of the society have taken umbrage at suggestions that their work for drug makers affects their scientific independence.

"There are those who accuse us of being nothing more than shills of industry; a lot of us take pretty great offence at that," said Dr Joseph L Izzo, a professor of medicine at the University of Buffalo who was part of the group that developed the new definition. "We've basically devoted our careers to researching this disease and how to treat it."

Dr Sealey's assertions had fuelled dissension within the society and were among the reasons that a vote to block her presidency had been expected at yesterday's business meeting of the society.

Instead, an agreement was forged under which Dr Sealey gave up her term as president and, according to written statements circulated among those attending the meeting, the organisation's leadership agreed that its board would soon submit detailed financial disclosure forms, which Dr Giles said had been in development for more than a year.

Dr Giles said those disclosures would go beyond the affiliations that were currently disclosed and would require leaders of the group to state how much they received, in broad categories.