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Junk Medicine

MagazineDecember 2012 (Vol. 23 Issue 9)Junk Medicine

Medicine prides itself on being a science, yet just 12 per cent of the drugs and treatments work


Medicine prides itself on being a science, yet just 12 per cent of the drugs and treatments work. The rest survives with blind faith.

Most of conventional med-icine doesn't work. You will probably be helped by just 12 per cent of the drugs and treatments prescribed by your doctor, while 57 per cent of what he commonly dispenses will either do you harm or have no effect whatsoever, although you will still run the risk of suffering a side-effect.

This damning picture has been created by a research team working with the British Medical Journal (BMJ) that has looked at the evidence for around 2,500 drugs and treatments used every day in surgeries and hospitals. And the true picture could be even bleaker than the one they present, and regularly update, in the Clinical Evidence Handbook (2012 BMJ Publishing Group). For a drug or treatment to be included in the 12 per cent that produce a benefit, the researchers have to find just one study involving one group of people that demonstrated a benefit, such as relief of symptoms, that was greater than any harm recorded by the participants.

"It does not mean that the drug will be effective in all people given that treatment or that other outcomes will be improved, or even that the same outcome will be improved at a different time after the treatment," says the editorial team.

The researchers also ignore the one thing that will distort the picture even further: medical fraud and spin. Up to 75 per cent of 'good' research published in even the most prestigious medical journals is, in fact, PR spin written by marketing departments and not by academics, estimates the Scientific-Ethical Committees for Copenhagen and Frederiks-berg Municipalities in Denmark. The research is paid for by the drug company that recruits the marketing company which, in turn, manipulates the data before massaging the conclusion-invariably demon-strating a beneficial effect-before recruiting an eminent academic prepared to put his or her name to a paper they haven't read, let alone written (PLoS Med, 2007; 4: e19).

If the level of fraud and spin is as bad as the researchers believe, the number of beneficial drugs and treatments-as measured by genuine and reliable research-falls to just 100 out of the 2,500 used every day, or 4 per cent of the total.

Ben Goldacre, for a long time the 'quack-busting' researcher of The Guardian newspaper column 'Bad Science', has recently shifted his focus to the state of medicine in his new book Bad Pharma (Fourth Estate, 2012). In it, he summarizes the problem like this: "Medicine is broken . . . we like to imagine that medicine is based on evidence, and the results of fair tests. In reality, those tests are often profoundly flawed. We like to imagine that doctors are familiar with the research literature, when in reality much of it is hidden from them by drug companies. We like to imagine that doctors are well-educated, when in reality much of their education is funded by industry. We like to imagine that regulators only let effective drugs on the market, when in reality they approve hopeless drugs, with data on side effects casually withheld from doctors and patients."

It ain't working

Even assuming medical fraud doesn't happen, there is evidence to suggest that just 12 per cent of drugs and treatments used by doctors do more good than harm. Their effectiveness has been demonstrated by at least one piece of evidence from systematic reviews, randomized controlled trials (RCTs) or "the best alternative source of informa-tion" that their benefits dramatically outweigh any possible harm or adverse side-effects.

Next are those that are "likely to be beneficial"-there is some evidence that they may do more good than harm, although the evidence is much weaker-and these represent 23 per cent of treatments and drugs. From this, a generous view of medicine would be that one-third of all drugs and treatments are likely to do more good than harm.

The rest are a "trade-off between benefits and harms" and represent 8 per cent of drugs and treatments, and those "unlikely to be beneficial"-for which there is hardly any evidence to suggest they are worth using-which represent a further 5 per cent.

The vast majority of medicine has an "unknown effectiveness". In all, 49 per cent of drugs and treatments have no evidence whatsoever to suggest they do any good. Finally and possibly most shocking of all, 3 per cent of therapies regularly employed by your doctor will do you harm. From this, it's not surprising that medicine has inadequate solutions to a wide range of conditions. Here are just a few.

  • Angina. Medicine's best remedy is the beta-blocker, although these drugs are only likely to help in stable chronic cases, according to the
BMJ researchers. However, new evidence suggests that the drug may be demoted to the next rung down to a 'trade-off' therapy, where the benefits and risks cancel each other out. Although they have been the front-line treatment for more than 40 years, these drugs don't prevent a heart attack, and research a few years ago demonstrated that they don't help reduce high blood pressure (hypertension) either (JAMA, 2012; 308: 1340-9).
  • Atrial fibrillation. Medicine has no answers when this heart problem is in its early and acute phase. The standard treatment for preventing an embolism is an antithrombotic drug, but there is no evidence to suggest it works.
  • Dyslipidaemia. People who have this condition, charac-terized by high levels of 'bad' LDL cholesterol, won't get any solutions from their doctor. Nothing available has any evidence it might work.
  • Febrile seizures. These seiz-ures usually happen with a high temperature in children between the ages of three months and five years-but there's no effective therapy the doctor can offer.
  • Pancreatic cancer. It's the fourth most common cause of cancer deaths, but surgery won't help you survive it. There's no evidence that the intervention can help.
  • Otitis media. There's good and bad news when it comes to treating this ear condition, especially when there's also a discharge. The good news is that antibiotics are likely to work; the bad news is that, according to other studies, there's no evidence that antibiotics help at all.
  • Ear wax. The doctor (or nurse) is likely to reach for the syringe if you complain of a bad case of ear wax. Although it's the standard response, there's no real evidence it works. At best, it's a trade-off between doing more good than harm.
  • Meni`ere's disease. This dis-order causes recurrent vertigo, hearing loss and tinnitus-but sadly, it also makes the doctor dizzy. All the usual drug therapies at his disposal don't work for either acute attacks or slowing the progress of the disease.
  • Tinnitus. This hearing pro-blem, often accompanied by a constant 'whistling' noise in the ear, affects up to 18 per cent of people. Although it's a relatively common problem, doctors have almost nothing to counter it. At best, they may suggest antidepressants-but these are only for sufferers who are also depressed-and they are also a trade-off between benefit and harm, while the tinnitus drugs have no evidence of effectiveness.
  • Kidney stones. Removing kidney stones is a common surgical procedure, which is surprising because there is no evidence that it either helps or stops stones recurring.
  • Prostate cancer. 'Catch it early' is the mantra when it comes to prostate cancer. Men who are in the early stages of the disease are often offered a radical prostatectomy, where the entire diseased gland is removed, but-at best-it's a trade-off mainly because of the harm it can do, such as causing impotence and incon-tinence, which happens in a large minority of patients.
  • Schizophrenia. Drugs are the doctor's remedy for this serious mental problem, but there's no evidence that they work.
  • Low back pain. Both acute and chronic lower-back pain seems to afflict most of us at some time or another, but there's very little the doctor can offer. The drugs for both types are again at best a trade-off, and can cause as much harm as good. The only approach that might work is body manipulation and exercise.

And it gets worse

This already gloomy picture assumes that the medical trials analyzed by the BMJ researchers were honest and aboveboard. But when you factor in the enormous amount of fraudulent research going on in medicine, the true effectiveness of conventional medicine looks very slight indeed.
If medical fraud is as prevalent as some researchers fear, it's possible that only 4 per cent of drugs and treatments-amount-ing to around a hundred different therapies and procedures-actually do more good than harm.

The extent of the problem and the tactics employed came to light when the drug company Wyeth was forced to release secret documents to lawyers who were representing around 14,000 women who had developed breast cancer after taking the com-pany's HRT (hormone replace-ment therapy) drug Prempro. Wyeth started using a PR firm, known as a 'medical education and communication company' (MECC), to prepare positive studies about its drug in 2002, after the Women's Health Initiative (WHI) discovered that HRT increased the risks of breast cancer and stroke.

Wyeth's damage-limitation exercise involved hiring MECC DesignWrite to prepare 'clinical trials' that demonstrated the safety of Prempro. Most of the trials were meta-analyses-a reinterpretation of previously published studies-that were given a positive spin, and a leading academic was hired to use his or her name as the lead author, although the academic hadn't written it and often hadn't even read it. In all, 18 'studies' prepared by DesignWrite were published across a range of influential professional journals such as the American Journal of Obstetrics & Gynecology and International Journal of Cardiology.

The exercise is but the tip of an iceberg. It's possible that around 90,000 'meta-analyses' published in medical journals over a 12-year period could be PR masquerading as proper scien-tific trials that doctors rely on before writing a prescription.

This estimate is based on a simple calculation. DesignWrite revealed that it has prepared 500 'clinical papers' for drug firms over a 12-year period and, as there are 180 MECCs of similar size and activity as DesignWrite, it follows that around 90,000 have been written and published over that period.

Adriane Fugh-Berman at Georgetown University Medical Center in Washington, DC, who has researched the world of the MECCs, says that every medical journal has been "infested" by industry-funded marketing messages these MECCs have published as scientific trials.

What's going wrong?

Essentially, the pharmaceutical industry's model of the mass production of a one-size-fits-all remedy may be delivering large profits, but it's not coming up with effective solutions for patients.

Drug companies are beginning to realize that people will start drifting away from a drugs-based solution if the products don't work, and we're already seeing that among the better-off who are prepared to pay more for alternative and nutrition-based remedies.

The response is likely to be more customized drugs to fit the individual, as GlaxoSmithKline's vice-president of genetics, Dr Allen Roses, suggested in a private meeting. During his presentation, he admitted that 90 per cent of his company's-or any other drug company's-products don't work on the maj-ority of patients (www.naturalnews. com/031287_pharmacogenomics_medicine.html).
This is also borne out in the laboratory. Scientists at Bayer recently revealed that they were unable to replicate the results of two-thirds of the studies of drugs designed for cancer, women's health issues and heart diseases (Nat Rev Drug Discov, 2011; 712: 328-9). Researchers from Amgen, ano-ther pharmaceutical company, fared even worse and were unable to replicate 47 of 53 "highly promising" drug trials for cancer and blood-related diseases (Nature, 2012; 483: 531-3)-but that's possibly because they weren't as promising as the original researchers suggested. As scientist Elizabeth Iorns, the CEO and co-founder of Science Exchange, explains: "The natural world is complex, and experimental methods do not always capture all possible variables."
In other words, the human body is a dynamic and complica-ted organism that is always changing, and life is complex too, and there are too many factors always at play to say for certain that drug x had y effect.

Is it a science?

Modern medicine prides itself on being a science-but is it? Poor results, widespread fraud and results that nobody can repeat all point to medicine being a pseudoscience, an activity that masquerades as science in an attempt to claim legitimacy. Science, on the other hand, is the testing of explanations and predictions about the universe
or, in the case of medicine, of treatments.

If it were a science, medicine would abandon nearly 90 per cent of the drugs and treatments it uses because there is little evidence to suggest they work. This isn't a dry academic point. Because it is seen as a science, medicine enjoys a privileged position in society. It is granted special protection under law, its represen-tatives sit on editorial boards that control what is printed and broadcast, and even advertising guidelines prohibit advertisements or marketing material that may interfere with the relationship of doctor and patient. Increasingly, the so-called science of medicine is being rebranded as 'evidence-based medicine' (EBM), which distinguishes it from every alternative therapy that apparently has no evidence whatsoever-or at least accord-ing to EBM proponents. This has powered a raft of European legislation that seeks to curb alternative therapies, even including vitamin supplements, while EBM champions have been reporting any health claims made on alternative practi-tioners' websites to the advertising authorities. Dr Brian Kaplan, who holds the unusual position of being a qualified doctor and a homeo-path, points out the paradox at the heart of medicine: while championing itself as evidence-based, the evidence doesn't actually support the work it does."I just want to see a level playing field. If alternative therapies are found wanting because the evidence doesn't support their efficacy, I want to see the same applied to those conventional treatments which also happen to fail the same litmus test."

If it was, conventional medi-cine would suffer a "hurricane of destruction", he says. "All doctors would be required to check the level of evidence for any treatment prescribed. In the spirit of the age, they would be coerced into informing many patients that certain drugs which they thought were helping them could no longer be prescribed because they didn't pass the EBM test," he said.

The conclusion of all this, says the popular-science magazine New Scientist, is that medical science is "built on shaky foundations" (New Scientist, 17 September, 2012; www.newscientist.com/ article/mg21528826.000-is-medical-science-built-on-shaky-foundations.html). Those foundations rest on the assumption that it's possible to mass-produce solutions to health problems. You can't. As drug companies are beginning to realize-as alternative therapists have known all along-that the patient, the disease and the remedy form a unique combi-nation that often doesn't fit standard-issue medicine.

Bryan Hubbard

Medicine's bully boys

Inspired by the belief that they are championing a science against the dark forces of superstition, medicine's many bully boys wage war against alternative medicine, its practitioners-and, latterly, even WDDTY.

They use all the powers the digital age offers, including blogs, tweets and social media, and they unleash their 'trolls' who vilify the selected target with personal and hateful invective. More recently, they have used the new powers of the Advertising Standards Authority (ASA) to 'persuade' alternative practitioners to remove any health claims they may be making on their websites.

The mantle has passed from one champion of medicine to another over the years, starting with UCL professor David Colquhoun's 'Improbable Science' blog to Ben Goldacre, for several years the author of The Guardian newspaper's column 'Bad Science'. But since he joined the Dark Side with his attack on conventional medicine, the mantle has passed to Simon Singh.

Singh co-authored the book Trick or Treatment with 'professor of complementary medicine' Edzard Ernst before writing an article in The Guardian about chiropractic, in which he claimed that the therapy was useless and that its practitioners promoted fake treatments. The British Chiropractic Association sued, but lost the case; since then, Singh has been campaigning for free speech and debate over scientific issues without the fear of libel.

Free speech doesn't extend to WDDTY, however. Singh tried to stop the circulation of the newsstand magazine version of this journal in October. He told the distributors that they were circulating a dangerous magazine, and his trolls complained to every retail outlet that they were stocking a "vile magazine", as one described us. Thus far, they have failed in their endeavours.

Singh is a trustee of Sense About Science, a lobby group that is part-funded by the Royal Pharmaceutical Society, the Wellcome Trust and others, including 'help' from The Guardian newspaper.

Singh is also the inspiration for the Nightingale Collaboration, which uses the new powers of the ASA to force alternative practitioners to remove any health claims they make on their websites.

Trials on trial

The most cherished instrument of medical science is the randomized controlled trial (RCT), where a group of people with a specific illness are randomly chosen to be given a drug, for example, and their progress is measured against another group, who may instead be given a sugar pill, or placebo, for comparison. Better yet, if neither the participants nor the researchers know which group's taking the drug or the placebo, the RCT then becomes a 'double-blind' controlled trial, the absolute gold standard for scientific medicine.

But the whole thing is a con, says James Penston, a leading statistician who spent 10 years in clinical research with a pharmaceutical company. The primary purpose of the RCT is to establish a direct cause-and-effect-that the drug being researched can ease the symptoms of a condition-but you almost never can achieve that, he argues, in his book Stats.con (The London Press, 2010).

In the first place, the difference in the final outcome between the 'active' group and the control group given the placebo is often very small, with the drug often outperforming the placebo by only a few per cent.

This difference is insignificant when all the true variables are factored in. For one, although two groups may be randomly selected, it doesn't mean they share all the same characteristics. While obvious ones like smoking can be factored in, one group may have more people who are depressed or do manual work, for example, which may have a bearing on the results.

But as Elizabeth Iorns pointed out (see main story), the real problem is that you're trying to measure a dynamic situation, including people, environment and lifestyle issues, which also vary over periods of time while the trial is being run.
Ultimately, the endpoint of every drug trial-that this drug definitely had a positive effect-is impossible to prove. But despite this, the sponsoring drug company immediately publishes these 'proven' beneficial effects, no matter how small, while suppressing the studies that show a negative outcome.

The results of RCTs form the foundations of 'best practice' for scientific medicine. They are adopted by NICE (National Institute for Health and Clinical Excellence) in the UK, and doctors' treatments are determined by NICE guidelines and aided by drug company 'reps', who are quick to point to the positive results of any study their company has sponsored.

The doctor who kills the patient while following NICE guidelines will rarely face censure, but another who gets the patient well by stepping out of the RCT straitjacket-as happened recently with Dr Sarah Myhill, who publicly decried mammograms as useless for cancer screening-will face the disapproval of the General Medical Council (GMC).

WDDTY November 2012 vol 23 no 8


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