Big Pharma


AntibioticsWe hear a lot about drugs: from kids peddling heroin in London’s inner cities to students huffing nitrous oxide in their bedrooms. Legal drug use, however, sometimes escapes our attention, and this is regrettable as its effects can be more significant. I have written before on the overuse of antibiotics, both when they are prescribed to men, women and children and when they are pumped into animals, and there have been intriguing developments on this front.

The US Centers for Disease Control has claimed that the development of antibiotic resistant bacteria sends 23,000 Americans to their deaths each year. Richard Schiffman observes that most of the antibiotics consumed in the US are administered to livestock, because, in part, it fattens the poor creatures up before their deaths. This is dangerous, and disgusting, but it is far from being the single factor. Men, women and children, who can spread bacteria amongst themselves in a more direct manner, are prescribed antibiotics in millions of cases where they are quite unnecessary. Modern populations have become addicted to drugs, as a means of defending themselves from the slightest illness, and in one of the grim ironies of existence it appears to be threatening them with grave sickness.

This is not a national problem, though. It has been globalised. Developing countries have embraced antibiotics as a cheap, convenient way of satisfying patients, and a cheap, convenient way to further the growth of meat production. The Indian government have admitted that between a fifth and a half of antibiotic prescription in the country is unnecessary, while in China the average person consumes many more times the amount of antibiotics than  the hardly abstemious Americans. These rates have, it’s claimed, been falling as officials grow wary of the pharmaceutical feasting they have overseen, but the expansion of hog, poultry and cow farming seems to be shifting the consumption elsewhere.

The effects of these trends can already be observed. A Chinese study founddiverse, abundant, and potentially mobile [antibiotic resistant genes] in farm samples”, while patients in hospitals have also teemed with them. Scientists are claiming that illnesses such as tuberculosis and Shigella infections are becoming harder to cure. A Swedish tourist who was treated in New Delhi, meanwhile, was found to have picked up a strain of bacteria that was extraordinarily powerful in resisting drugs. This proves to us that this is a concern for everyone. Professor Matthew Cooper of the Australian Infectious Diseases Research Centre has observed that, “Animals get transported between countries, as do people. Infectious disease is no longer a national issue, it’s a global issue.”

The scientific and technological knowledge of civilisations need not advance in lockstep with their sagacity and moral conviction. So, the modern world has been so enamoured of the convenience and profitability of this most wondrous example of medical progress that it has exploited it regardless of potential hazards. As for ethics, well, the gross distending of animals in the vast new meat production industries of developing nations shows, as was already proved on Western factory farms, that modernisation can only expand the scale on which cruelty is practiced. China, for example, where horses and dogs are dined upon and bears are slaughtered for their bile, is home to even less concern for animals than Europe or America, and countless pigs, chickens and cows on its ever enlarging farms are doomed to lives of pain. It is when we are sensitive to the effects of our behaviour on all creatures that we might succeed in making it less destructive.

AntibioticsDame Sally Davies, Chief Medical Officer for England, has been beating the drum over the threat of antibiotic resistance. It is, she claims, a “ticking time-bomb not only for the UK but also for the world”. Indeed, doctors in Canada, academics in Australia and politicians in America have been wringing their hands over this phenomenon. One problem, it seems, is that the development of new antibiotics has been slow. Correspondents of the British Medical Journal, however, offer what they call “an important and alarming caveat”…

…new antibiotics alone are not enough to eliminate the threat of drug-resistant bacteria. Indeed, given their rapid turnover and high mutation rate, it is inevitable that bacteria will develop resistance to any newly developed drug regardless of the pharmacological mechanism of action. Thus interventions to tackle antibiotic resistance must focus on targeting misuse and over-prescription.

Antibiotics are often prescribed for such complaints as sore throats, middle ear infections and coughs that they do little to ease and that do not justify their use. Doctors, though, presented with distressed patients or the demanding parents of ailing children, are liable to offer them.

In Britain, doctors have said that there is “clear scope for reductions in antibiotic prescribing”. In America, millions of cases of antibiotic prescription have been found to be unnecessary and over a hundred thousand people, most of them young children, have been admitted to hospital after suffering adverse effects from their treatment. The most frightening case, though, is China, where powerful monetary incentives for prescribing has led to the extraordinary rates that Qiang Sun and his colleagues described in Health Affairs

 In Henan, China’s most populous province with nearly 100 million residents, antibiotics constituted fully 70 percent of prescriptions in village clinics and township health centers. Another study found that 98 percent of outpatients with a common cold were prescribed antibiotics. One study has estimated that approximately half of antibiotic prescriptions in China were medically unnecessary and implicated in more than one million children’s becoming deaf or suffering neurological disorders.

The Chinese government began to fight back against overprescription last year, after it was estimated that its citizens use an average of 138 grams of antibiotics per year – ten times that of Americans. If you consuming far more of a product than the average American, and it isn’t green and vegetably, that is more often that not a cause for concern.

The other problem, as I have discussed before, is the use of antibiotics in the raising of animals for their flesh, milk and eggs. In the EU, drugs are at least banned as a means of growth promotion but they are still used in vast quantities, largely in factory farms, where crowding, stress and aggressive, unsuitable diets seem likely to provoke illness.

In America, where almost four times as many antibiotics are sold for meat and poultry production as to treat ailing people, they are still used like steroids to bulk up miserable creatures. So it seems to have been in China, where a recent study into contaminants in swine farms found…

Diverse, abundant, and potentially mobile [antibiotic resistant genes] in farm samples [that] suggest that unmonitored use of antibiotics and metals is causing the emergence and release of ARGs to the environment.

Education programs that discourage seeking antibiotics to treat minor and unsuitable illnesses have proved successful in the past, and education programs, formal or otherwise, on the distressing conditions of factory farms may help to curb appetites for their products. I am sure drug regulations could be tightened for such places but a more effective solution would be to end the demand for the goods that inspire these practices. (This is, of course, one of many reasons for not encouraging the abuse of animals.)

As Professor Matthew Cooper of the Australian Infectious Diseases Research Centre says, though: “Animals get transported between countries, as do people. Infectious disease is no longer a national issue, it’s a global issue.” The idle distribution of antibiotics across China and also India and South-East Asia has contributed to the formation of such dangerous conditions that experts are warning that tourists are shuttling infections back with them. There should be a concerted international effort to address this problem, as it would be a tragedy of vomitous proportions if our aversion to discomfort and appetite for cheap sausages was a cause of devastation.

DrugsA few weeks ago I reported on the fact that tens of thousands of elderly Britons are being prescribed antipsychotics despite the fact that a governmental report has concluded that most patient derive no benefit from this and one in a hundred will die as a result of taking them. Others are liable to endure weight gain, diabetes, hyperlipidemia and cardiac dysfunction, as well as life amid the torpor of a chemical cosh.

Things seem to be even worse in the United States. According to Becky A. Briesacher and her colleagues from the University of Massachusetts, more than one in five of its nursing home residents have been prescribed them. It is known that many of them do not profit from and, indeed, are harmed by their drugs. One study on patients admitted to nursing homes after hip fractures found that their use of antipsychotics was associated only with adverse outcomes. One wonders if the doctors had been told “first, do no harm” and somehow failed to internalise the penultimate word.

Antipsychotic use is also extremely high among American children and adolescents. More young people than ever are taking such drugs, and most of them are being prescribed in response to conditions they have not been approved to treat, such as ADHD or post-traumatic stress. An investigative report into their use in juvenile prisons and residential programs found that they were being doled out to treat everything from anxiety to sleeplessness.

There has been some evidence that some antipsychotics reduce aggression and conduct problems in children diagnosed with disruptive behaviour disorders but recent studies have described it as “limited” and “incomplete”, and judged that off-label prescriptions are a “cause for concern”. This is because, as well as having questionable virtues, they are known to carry serious risks for children and adolescents, and have been linked to metabolic dysfunction, cardiovascular adverse events and abnormal involuntary movements. It is also eerily true that their long-term effects remain mysterious, and studies have suggested that prolonged use may worsen brain tissue loss.

There are significant interests behind the growth of the market in antipsychotics, of course. It nets fourteen billion dollars per year for Big Pharma, and full 58% of which comes from Americans. As in the cases of other drugs, manufacturers have been sly in promoting their goods. In Florida prisons the investigative report exposed, for example, doctors who had been prescribing drugs were also accepting “huge speaker fees and other gifts from makers of antipsychotic pills”. This does not mean they need have been less objective than other doctors but it was a conflict of interest that it was significant enough that they could have been. Shahram Ahari, a one-time Big Pharma sales-rep who went rogue, revealed that drug companies rank physicians according to the rate at which they prescribe their products, and then offer gifts accordingly.

The behaviour of drug companies has been exposed in numerous lawsuits. Omnicore, which supplies drugs to nursing homes, paid out ninety-eight billion dollars after it was alleged that they had accepted kickbacks from the drug company Johnson & Johnson in exchange for recommending that elderly patients be prescribed one of their brands of antipsychotic. Johnson & Johnson later agreed to pay billions after being charged with marketing the same drug for unapproved uses. Pfizer, meanwhile, was fined after “maintain[ing] on its payroll an army of more than 250 child psychiatrists” to help promote an antipsychotic drug that had not been approved for children. This corruption is enough to give one a headache, though I would not recommend buying painkillers to deal with it.

I will not market myself as an expert on psychiatry or pharmaceuticals. It seems to generally accepted that antipsychotics are efficacious in treating certain conditions, and I can empathise with at least some of the people who recommend them to disorderly youths. This is not to say that it is the right thing to do but that I have been around kids with a great deal of energy and a great absence of respect and understand why people feel pacification is required.

Yet it seems bizarre that drugs with benefits that remain so unclear; long-term effects that are so mysterious and adverse consequences that are so evident and so obnoxious are used in such quantities. The forces behind them make the phenomenon seem more comprehensible yet also more sinister. It is tragic that old people are drugged into states of lethargy until their unassuming deaths but it is also frightening to think of the futures of the kids whose youths will bear the marks of psychological restraints, and whose growing brains may have been choked by their confinement. It seems so much more civilised than straitjackets, yet at least the old camisoles left inmates with their own minds, and at least we could be sure that their wounds would fade.

The irony is that there is another sedative that gives comfort to some of its users but has been linked to deleterious long-term results – though not, it must be said, adverse short-term effects or death among the aged. This drug has inspired Americans to spend billions of dollars, lock up thousands of their prisoners and keep their neighbouring nation mired in brutal violence. These drugs, though, it seems, are no big deal.

I’ve got a toothache. Actually, that’s incorrect: there’s a great deal of stinging too, and the pain isn’t restricted to a molar or a canine but throbs within many teeth and tears through both my gums. The problem has even left me with an earache, though that might have passed had I not loitered in front of the speakers as a bunch of a local bands thrashed out breakdown after bloody breakdown.

One thing that I haven’t done is taken painkillers. Not because I’m a descendant of Zamora the Torture King and feel cheerfully resistant to pain. No, I’ve spent more than a few unhappy hours groaning, growling and grinding my teeth. Yet I would like to become less sensitive to suffering.

As a people we got through six billion oral analgesics in the last year. We consume so many painkillers, it appears, that many are overdosing on the bloody things and giving themselves headaches. (Which, of course, they treat with further painkillers.) I’m not going to be some kind of grim faced, gimlet-eyed ascetic: people with serious and persistent conditions doubtless benefit from the relief these makeshift medicines can offer. Yet the haste with which people resort to the things is quite depressing. Someone on the train a couple of days ago was loudly informing no one in particular that they were going to take a couple for a slight headache. They might have cured it if they’d just kept their voice down.

We despise inconvenience but our efforts to avoid it can make us more susceptible to discomfort. Think, say, of the people who are so used to driving or taking public transport wherever they go that when the car is on the blink or the bus fails to arrive they’re appalled by the idea of being forced to walk a mile. Those who fumble for painkillers at the first sign of affliction never learn to bear and struggle through annoyances. When they experience physical malaise – be it fatigue, wounds or passing ailments – that pills fail to ease they’re devastated.

Analgesics can also distract one from acknowledging the causes of discomfort. Pain is not simply an enemy: it’s a symptom of harmful conditions that can motivate us to diagnose, treat and struggle to avoid them. Lepers, whose nerve endings die, causing them to feel less pain, can break limbs because they never realised they were twisted awkward positions. Someone who quiets the warning signals of their body could fail to recognise disorders they’re symptomatic of and take preventive treatments or make lifestyle changes that may cure them.

Painkillers, then, as with so many of the products of our age, can be obscurantists under the guise of elegance; quick fixes make for long-term problems. And, besides, their adverts give me sodding migraines.

Ben Goldacre’s new book is titled Bad Pharma. Describing its contents would, I think, be as needless as explaining the pun. He’s published an extract in the Guardian that details the lengths that GlaxoSmithKline went to in trying to market the anti-depressant paroxetine to children; avoiding the exposure of the fact that it would be unhelpful and potentially dangerous…

People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

He reflects…

How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

The risks of paroxetine were exposed in late 2003. In the spring of that year a conference was hosted by The Atlantic Bridge, the one-man bandwagon of the then Shadow Health Secretary Liam Fox. It would grow to be a focal point of Anglo-American hawkishness but in that year its concerns were more parochial. The conference was titled “Scientific Research and Medical Provision: The Anglo-American Dynamic” and it seems to have been a love-in for free marketeers and industry representatives. Fox, along with Atlantic Bridge officials Bill Clare and Gabrielle Bertin – both of whom, to show how partisan the group was from that start, were spin-doctors for the Tories – played host to high-ups of Pfizer, Novartis and Cyclacel, as well as employees of the freemarket think tanks the ASI and the Galen Institute. No surprises here, perhaps, but the details of one of the talks are grimly amusing…

“The Threats to Development: Regulation, Finance and the Militant Activists”

What are the structural, cultural and political obstacles to Research and Development in Europe? How best can we tackle the destructive force of activists? The future of intellectual property protection.

Dr. Timothy Morris, Head of Comparative Medicine, GlaxoSmithKline

Much as they dislike the fact, the record of GlaxoSmithKline stands as proof of the necessity of stringent regulation. I don’t think that the Conservatives can be trusted to provide it, though.

Liam Fox, our ridiculous Defence Secretary, has been in the news after it was revealed that he’s been giving a friend of his access to MoD files. This pal, the Guardian reports, had run a think tank Fox has established. This, coincidentally, was dissolved last week after the Charity Commission said that, well – its activities weren’t very charitable…

A charity set up by Liam Fox, the defence secretary, has been dissolved by its trustees after criticism by the Charity Commission.

The Atlantic Bridge, which had already been suspended for promoting Conservative party policies in defiance of regulations, was founded by Fox and run by his close friend Adam Werritty.

Fox’s relationship with Werrity was drawn into question when the Guardian revealed Werritty had visited Fox at Ministry of Defence offices 14 times in the past 16 months.

Oh, that think tank.

I don’t know why I spent so much time raking through the details of a minor league think tank. (I even made a Wikipedia page for the blasted thing.) Still, while it’s in the news it’s worth revisiting. The Atlantic Bridge was set up to give British and American conservatives a chance to meet and share ideas and, in Fox’s words, create an “intellectual framework that will strengthen the special relationship”. It was, then, the sort of “social club” that sociologist William Domhoff claims provides elites with opportunities to “reach consensus” and “affirm cohesion”.

(more…)

The field of psychiatry appears to be enduring a renewed and, it seems to me, well-deserved assault. Richard Bentall’s fascinating Doctoring the Mind, published in 2009, essentially argued that there are three defects with in practices: no one’s sure of how to explain mental phenomena; no one’s sure of how to diagnose their conditions and no one’s sure of how to treat them. Actually, there are four, and the fourth could be the most important: far too many people are ignoring these uncertainties. Reductionist social and, increasingly, biological hypotheses are adduced as scientific truths; characteristics are wedged inside questionable diagnoses and, of course, Big Pharma-formulated treatments are doled out by the million. It seems to be a lethal mix of complacent ideology and corporate influence.

In the New York Review of Books Marcia Angell introduces recent tomes that offer similar conclusions

The books by Irving Kirsch, Robert Whitaker, and Daniel Carlat are powerful indictments of the way psychiatry is now practiced. They document the “frenzy” of diagnosis, the overuse of drugs with sometimes devastating side effects, and widespread conflicts of interest. Critics of these books might argue, as Nancy Andreasen implied in her paper on the loss of brain tissue with long-term antipsychotic treatment, that the side effects are the price that must be paid to relieve the suffering caused by mental illness. If we knew that the benefits of psychoactive drugs outweighed their harms, that would be a strong argument, since there is no doubt that many people suffer grievously from mental illness. But as Kirsch, Whitaker, and Carlat argue convincingly, that expectation may be wrong.

At the very least, we need to stop thinking of psychoactive drugs as the best, and often the only, treatment for mental illness or emotional distress. Both psychotherapy and exercise have been shown to be as effective as drugs for depression, and their effects are longer-lasting, but unfortunately, there is no industry to push these alternatives and Americans have come to believe that pills must be more potent. More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education.

A report(pdf) by the watchdog Public Citizen studies the endemic fraud of the pharmaceutical trade. In the last two decades they’ve forked out for nearly twenty billion bucks in penalties with half coming from Pfizer, Eli Lilly, GlaxoSmithKline and Schering-Plough alone. Violations have only increased in recent times. The report notes that these fines may not be a worthwhile deterrent – after all, Pfizer and GlaxoSmithKline have paid out a total of nearly 8 billion and swept up profits of over twice that in a single year – and speculates that executives could be jailed.

Oh, my dears, the best of luck with that. Obama showed us where his administration stood by crafting his healthcare reforms around Big Pharma’s every wont. Harry Reid has been so faithful to it that Pfizer and others have become his gracious patrons. Once upon a time Obama used Wilbert Tauzin, President of PhRMA, the trade group that represents Big Pharma, as a sad example of the “game playing in Washington“. Once he’d been elected, Tauzin soon became his guest and comrade, making sure the healthcare deal would benefit his chums before tossing a few coins the way of the Senate majority leader. I could be wrong but I think they’re as likely to get tough with Pharma as a cop is with the loan shark who backhands him a few hundred.

The report suggests that the drug industry may be even more corrupt than the arms trade. As the past decades have shown us, its members have no more qualms about the pain of foreigners. In this month’s Vanity Fair James Steele and Donald Bartlett write on the alarming rise of globalised clinical research, whereby drugs are tested on confused, indigent volunteers at barely regulated sites. The Food and Drug Administration scarcely monitors these trials and several have marked by “what the U.S. clinical-trials community refers to as “an adverse event”“: the deaths of its subjects. This was true of Pfizer who, if we’re to believe this Wikileaked cable, then hired investigators to smear the man who took them to Court. Anything to smooth the path of – ahem – progress.

Ah, progress. Big Pharma’s swindling is on the rise; its exploitation is growing and, of course, prescription drug use is soaring like ne’er before. With the U.S. state and perhaps our own Tories on its side it’s hard to see who’ll rein in its piratical tendencies. And as we’re dependent on the little pills that it supplies that’s a discomfiting thought.

Two quick pieces of Fox Hunting. (Fox, it seems, has now become my Conservative bête noire. His Labour equivalent, Denis MacShane, is now subject to a police investigation. Maybe I’m a curse!)

I

Here’s a grimy little nugget on the Atlantic Bridge. I dredged up a conference that Liam Fox, then Shadow Secretary for Health, had organised for journalists and powermongers, “Scientific Research and Medical Provision”. Big Pharma representatives spoke out on “threats to development” – “regulation” and “militant activists“, apparently – while a critic of government-controlled medicine gave an address on “[whether] the…UK health care model [was] sustainable”. I noted the irony of congenital liars GlaxoSmithKline whining about regulation; what I hadn’t noticed is that Pfizer, who attended, funding the Atlantic Bridge. At a time when they were being charged for testing risky drugs on helpless Nigerian kids, funding anti-regulatory promotion takes some balls. As for Mr Fox, who chaired this smooth propagandistic meet-up, well – what else can one expect from the man who said he “do[es]n’t think we support our defence industry enough” at an event sponsored by the guys at BAE.

II

One of the intriguing things about lobbyists is that – unlike journalists or politicians – they wield influence without being public figures. Thus, despite the fine efforts of bodies like Sourcewatch, they’re tricky to hold to account. (As are the other two, of course, but at least you can see who’s stiffing you.)

Another patron of the Bridge was a businessman named Michael Lewis. Lewis is about as influential as one can be while remaining utterly unknown. He’s a one-time board member of the Conservative Friends of Israel and is now the Deputy Chairman of BICOM, the Britain Israel Communications & Research Centre. The latter has the cheery aim of “creating a more supportive environment for Israel in the UK“.  There’s nothing inherently sinister about this – people are free to donate money, and ring-fence their private lives – but I find it interesting that as well as shoving thousands at the Atlantic Bridge, Lewis donated to Fox’s leadership campaign. How much inter-Cabinet strife ever exists is doubtful; either way, while Liam’s around the hawks will be crowing.

You may now remove your anoraks.

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