Jim Giles http://www.newstatesman.com/writers/jim_giles en <![CDATA[Are the kids asleep yet?]]> http://www.newstatesman.com/society/2007/12/drug-companies-rozerem <div class="field field-name-field-subheadline field-type-text-long field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even"><p>Observations on drugs</p> </div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even" property="content:encoded"> <p>It's the prize no company wants. But the victor in the Bad Products Awards 2007, organised by the US-based Consumers International (CI), certainly deserved to win. Tough competition came from Mattel for having sold 21 million toys with design faults that included dangerously high levels of lead. Coca-Cola's mineral water that turned out to be tap water earned a mention. But Takeda Pharmaceuticals was a worthy overall champion for its promotion of sleeping pills to children.</p> <p>The television ads for Takeda's pill, which goes by the name of Rozerem, aired in the US in autumn 2006, just as the school term was beginning. Visuals included shots of textbooks, yellow school buses and children carrying backpacks. A voice-over declared: "Rozerem would like to remind you that it's back to school season," and recommended that viewers "ask your doctor today if Rozerem is right for you". The final shot contained the drug's logo and the tagline "Back to School".</p> <p>As CI said, announcing the award: "It doesn't take a PhD in marketing to see this is an effort to persuade parents to seek out the sleeping drug for their children - to help them get through the stress of term starting."</p> <p>Yet Rozerem is approved only for adults. One reason for this, which the marketing folk would have been aware of from the safety label that comes with every packet, is that the drug can affect levels of reproductive hormones such as testosterone. Since it is unclear what would happen if children's hormone levels were disturbed by the pills, regulators had decided the product should be adults-only. What is shocking is what happened next. The answer being: not much. Complaints were made, but the US Food and Drug Admin istration did nothing until March 2007, by which time the ads were no longer running. Takeda got a mild ticking off, which it managed to brush aside by blaming an external marketing firm for acting without its approval.</p> <p>If this sounds a uniquely American story, think again. At the moment, the US and New Zealand are the only two countries where drug companies can advertise prescription drugs direct to consumers. But the industry has Europe in its sights.</p> <p>Under proposals being considered by the European Commission, companies would be able to fund non-promotional health education material. To hear industry talk, this would be a win-win solution: companies could inform the public about their products, while patients would get access to educational materials at no cost to the taxpayer.</p> <p>It will be advertising by the back door. In the US, more than half of the continuing-education courses physicians take after qualifying are paid for by drug companies. One recent study of 17 educational events paid for by drug firms revealed a clear bias in more than half. Speakers would discuss the benefits of a sponsor's drug, for example, but downplay side effects and ignore rival products.</p> <p>Europe may not not see anything as bad as the Rozerem ads if drug firms are given a hand in generating educational materials. But why take the risk? Public education is best done by public bodies.</p> </div></div></div> Thu, 06 Dec 2007 12:00:00 +0000 Jim Giles 158940 at http://www.newstatesman.com <![CDATA[Physician, heal thyself]]> http://www.newstatesman.com/society/2007/10/industry-doctors-drug-pharma <div class="field field-name-field-subheadline field-type-text-long field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even"><p>Observations on Big Pharma</p> </div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even" property="content:encoded"> <p>A study published in the United States at the end of last month should worry all concerned about health care. It detailed the deep financial ties between the pharmaceutical industry and the academics who educate medical students. The study, by Eric Campbell of Massachusetts General Hospital in Boston, a leading expert on health care, has exposed the extent to which drug companies buy influence in medicine and precisely how extensive are the links between America's medical schools and drug companies.</p> <p>Some sit on boards of directors. Others have stock options. Grant money for research is commonly accepted, as are fees for giving lectures about a company's drugs. Of the 460 departments surveyed, only a third operated independently of industry influence. Five department heads admitted that drug company reps had given them gifts such as tickets to sporting events, prohibited by industry and academic guidelines. And the reaction from doctors? Almost nothing.</p> <p>It is not that the results lack significance, nor that doctors are unconcerned about the influence of the big pharmaceutical firms.</p> <p>Hundreds of studies have shown that industry money corrupts other areas of medicine, from the distortion of clinical trials through to the financial kickbacks that doctors receive for prescribing specific drugs. Drug companies spend more than $1bn a year on continuing education for doctors, for example, and such investments are not made without an expectation of a return.</p> <p>Academics are well aware of the industry's dubious record and that drug companies have faced plenty of negative publicity in recent years. Pharmaceutical sales reps are known to have given doctors misleading information. Patients have died because drug-makers were not honest about side effects. Overall, the scandals have cost the industry billions and wrecked its reputation.</p> <p>Each successive revelation prompts calls for reform from doctors. But the latest drugs bill, passed by Congress last month, contained little to trouble the industry. Big Pharma makes big donations to politics, too.</p> <p>One reason for the muted response to the revelations of new links with academia is fatigue. Hundreds of studies have revealed the corrupting influence of industry, and the law of diminishing returns is at work. There is another reason, too. The doctors who accept industry funds know all about the studies that show the corrupting influence of money.</p> <p>Psychological research suggests they continue to cash the industry's cheques because each believes he is incorruptible while believing that others would be influenced by gifts. The same thing happens among academics. Many medical school heads who took part in the latest survey said they believed large grants from drug companies could indeed cause bias in teaching or research.</p> <p>Yet, in clear contradiction, most medical schools routinely accept the grants. The answer lies in human nature. While hundreds of studies show that pharmaceutical money distorts almost every aspect of medicine, each chair of these medical schools believes that he or she is personally immune to such persuasion.</p> </div></div></div> Thu, 25 Oct 2007 12:00:00 +0000 Jim Giles 158479 at http://www.newstatesman.com <![CDATA[Time for a clever pill]]> http://www.newstatesman.com/society/2007/03/cx717-drug-drowsiness <div class="field field-name-field-subheadline field-type-text-long field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even"><p>Shake off that hangover drowsiness with the help of an experimental drug</p> </div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even" property="content:encoded"> <p>Last weekend was exhausting. I stayed out late on Friday and Saturday nights. I drank too much. On Sunday, I got up early and drove a long way to see a football match. My team lost. By Monday, what I really wanted was some CX717.</p> <p>I can't have it right now, as CX717 is an experimental drug. Its developer - Cortex Pharmaceuticals of California - is keeping a tight hold on it. Clinical trials are being run to test its safety - thousands of them at any one time - yet there is a buzz about CX717 already. It'll be years before it hits the market, but people, including me, want it already.</p> <p>We want CX717 because it appears to wipe out that slow-thinking drowsiness that a lack of sleep brings on. It's early days, but initial experiments show that sleep-deprived monkeys given CX717 perform as well on cognitive tests as those who had slept soundly. The results are exciting enough to have landed Cortex research papers in top-ranked scientific journals. Humans seem to benefit as well, and none of the experiments has revealed any serious side-effects.</p> <p>Results like this are enough to have investors throwing millions at Cortex. But there is another side to the drug that could turn it into an even bigger earner. CX717 doesn't just make you think better when you're tired. It makes you think better when you're not. In other words, it makes you cleverer.</p> <p>Just how much cleverer is something that will become clear as the drug is tested. It may be little more than the sharper thinking and better recall we get from coffee. It may be noticeably more than that. In a sense it doesn't matter, because CX717 is only one of several drugs being developed to do the same thing. It's likely that at least one will clear safety testing and hit the market in the next five years or so.</p> <p>So why aren't we talking about all this? There are big questions to be answered. Will employees be pressured into taking drugs in order to work longer hours? What if students want to take them but only the rich ones can afford to? Should less affluent students be given them, for example? Or should we just relax: if a drug can make us more alert without harming us, isn't that a good thing?</p> <p>One reason why we're not talking about this is that CX717 is not marketed as a clever pill; it's being tested as a treatment for brain disorders, including Alzheimer's. Yet, if it gets approval, something interesting is likely to happen. Doctors, particularly in the US, could prescribe the drug for people who simply want a pick-me-up. Internet pharmacies could make it available to anyone. The same has happened with Viagra; originally licensed as a treatment for erectile dysfunction, it is now used by couples who just want more of a good thing.</p> <p>But drugs such as CX717 shouldn't enter the market under the radar. As the think-tank Demos has pointed out, technologies should be discussed at an early stage of development, not moments before they are deployed. Cortex, and other drugs companies, need to come clean about their products and sponsor such a debate. CX717 sounds a good product. I'd just like to hear all sides of the story before it hits the pharmacy shelves.</p> </div></div></div> Mon, 12 Mar 2007 12:00:00 +0000 Jim Giles 155899 at http://www.newstatesman.com <![CDATA[Fizzy thinking]]> http://www.newstatesman.com/society/2007/01/scientific-research-industry <div class="field field-name-field-subheadline field-type-text-long field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even"><p>Observations on scientific research</p> </div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even" property="content:encoded"> <p>Parents fret about the health of their kids, so it's nice when impartial folk come up with reassuring advice. Should I let the children drink that syrupy gloop they're demanding? Ask a qualified scientist. Some public servant out there will have studied the product in question and can give us an answer to trust. </p> <p>Except that very often we can't, because the public is not paying the scientists. As a consequence, the results may not be impartial. There are scientific papers on the health effects of soft drinks written by researchers who appear to be independent - they work in public universities, for example, rather than for drinks companies. Yet many of those researchers receive grants from drinks firms. And when industry-funded experiments are compared with ones that the public has paid for, the independence of the scientists looks less clear.</p> <p>According to one recent survey, the first of its kind to look at the beverage industry, scientists are up to eight times more likely to reach positive conclusions about a drink when they have been funded by the beverage firm. In fact, in one study examined by the authors, they could not find a single industry experiment that concluded with bad news for the sponsors. </p> <p>Equivalent experiments funded by non-industry sources resulted in more than a third having critical things to say about the drinks being studied.</p> <p>Yet the corrupting influence of big business on scientific results has been documented in detail in the pharmaceuticals industry. We know that regulatory decisions about drugs are routinely undermined by the big companies. There is no conspiracy or fraud here, just a systematic distortion. </p> <p>But as with the drinks studies, commercially funded drugs trials are more likely to reach positive conclusions. Corporate researchers are also more prone to exaggerating beneficial effects. And negative results, which could signal the end for a product that has absorbed millions of pounds of development money, tend to be watered down or not published at all. </p> <p>Some drugs get licensed and are subsequently shown to be dangerous, such as the painkiller Vioxx, which was pulled from the market in 2004 after being shown to increase the risk of heart attack. The Vioxx problem might have been spotted sooner had some negative data been published earlier, but such cases are rare. The drugs companies are not setting out to sell dangerous products. They are merely trying to maintain a competitive edge.</p> <p>That does not make the industry's behaviour acceptable. Patients sign up for clinical trials thinking they are helping medical science, not to become a number in a marketing exercise. And drugs are expensive, so it matters which ones governments buy. </p> <p>To rein in the pharmaceuticals companies, medical research needs to be transparent. Clinical trials should be registered in advance, so the results cannot be hidden and the data should be made freely available, so that a statistical sleight of hand cannot be used to conjure good results from bad. </p> <p>And, as we become more aware of the impact on health of the chemicals used in food processing, similar standards should be applied to the food and drinks industry. </p> <p>So why aren't scientists in both industries already abiding by such standards? The World Health Organisation has a plan in place, but no power to enforce it. That rests with governments, and ours is ambivalent. New science institutions are springing up in China and India. Pharmaceutical companies will not hesitate to head east should it make economic sense. </p> <p>In the meantime, we should be wary of "independent" scientific research findings.</p> </div></div></div> Mon, 22 Jan 2007 12:00:00 +0000 Jim Giles 155373 at http://www.newstatesman.com <![CDATA[It's so hard to be nice]]> http://www.newstatesman.com/node/154935 <div class="field field-name-field-subheadline field-type-text-long field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even"><p>Observations on drugs</p> </div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden view-mode-fulltext"><div class="field-items"><div class="field-item even" property="content:encoded"> <p>It cannot be easy to listen to a plea from a man with a disabling and terminal disease and be told, while the nation listens, that you are the reason he will not be helped. </p> <p>Yet, that was how Andrew Dillon's day started recently, when as chief executive of the National Institute for Health and Clinical Excellence (Nice) he was confronted on the <em>Today</em> programme with the testimony of a man with Alzheimer's disease, shortly after Nice had decided that the National Health Service could not afford the cost of the sufferer's drugs. </p> <p>It was not the first time that Dillon has been thus vilified. He no doubt expects it. Nice weighs up the economic and clinical case for the NHS paying for new drugs. Limited budgets mean some treatments don't make the cut. But pressure on Dillon is coming not only from those whose health may be affected by his decisions. The drugs companies would rather it was them, and not Nice, who influenced doctors' prescription decisions.</p> <p>Dillon's organisation is therefore an obstacle. Three pharmaceutical companies are seeking a judicial review of Nice's Alzheimer's decision and have armed themselves with rhetoric that revolves around dying patients and long-suffering carers. They are, of course, the same firms that stand to make millions if the NHS buys their drugs. </p> <p>It is not the first time that patients have proved useful allies for these firms. Funding patients' groups makes sense, since complaints from sufferers carry enormous emotional weight, especially when a condition as traumatic as Alzheimer's is involved. Yet funding these groups is not necessarily about helping patients. When the Commons Health Select Committee investigated the pharmaceutical industry last year, it concluded that such funding should be considered part of the "relentless and pervasive" promotional efforts of the industry. </p> <p>It is in the interests of pharmaceutical companies that decisions about what drugs are prescribed rest with doctors and patients. They want to be allowed to advertise to both groups. US deputy health secretary Alex Azar, whose Republican party benefits hugely from pharmaceutical industry donations, made his views on this clear when he lobbied Health Secretary Patricia Hewitt earlier this month. </p> <p>But a look across the Atlantic at the system Azar helps run tells us precisely why Hewitt must resist his lobbying. The US healthcare system is both unjust and inefficient.</p> <p>American prescription costs are paid by healthcare insurance. Drug choice then rests with doctors, so pharmaceutical companies woo them with gifts ranging from free pens to conference junkets. Patients can also request specific medicines. Watch evening TV in the States and you face pitches for anything from anti-depressants to treatments for irritable-bowel syndrome. </p> <p>The result of this free-for-all is that access to drugs depends on the amount you pay in insurance. It also means that drugs companies end up spending billions of dollars on advertising. Some estimates put the total marketing budget of Big Pharma above that of their research spend. Such costs necessarily increase the price of drugs.</p> <p>So, when Nice's decisions do not make for nice reading, as they often don't, we should bear in mind that it is better for those with emotional and financial interests in a drug to be kept at arm's length from decisions about paying for it. It is a harsh truth for those who suffer from ailments such as Alzheimer's, or those caring for them.</p> <p>But companies disappointed that they may lose out from Nice's decision must simply be told to stay out of a process about which they cannot be objective. They must, as they already do, be able to make their case to Nice. After that, it has to be up to independent experts to make the tough decisions about how scarce NHS resources can be spent most fairly.</p> </div></div></div> Mon, 27 Nov 2006 12:00:00 +0000 Jim Giles 154935 at http://www.newstatesman.com