Drug companies exaggerate their successes, hide their failures and generally fail to abide by the rules of evidence based medicine. This ongoing fraud is the subject of the latest book from Guardian columnist Ben Goldacre, better known as merciless scourge of “woo” merchants cynically flogging worthless complementary and alternative medicine (CAM) treatments.
An extract from the book appears in the current Guardian weekend magazine and I’m happy to give Ben’s “Bad Pharma” a plug because that is what I and a few others in the UK have been saying for years. Welcome to the club, Ben.
Several of the cheating cases featured in the extract, for instance, are also to be found in “Food is Better Medicine than Drugs”, the book written by myself and one of Ben’s favourite targets Patrick Holford and published way back in 2006. There are more in the latest one “10 Secrets of Healthy Ageing”
We also pointed out around the time that if he was really worried about woo-type treatments with a poor evidence base, then drug marketing offered a rich seam. Instead Ben continued using his Guardian column to pillory anybody advocating treatments that had a tiny fraction of the potential for harm that drugs do, such as vitamins, nutritional supplements and dietary changes. But hey, better late than never.
What’s Ben for?
But the welcome change of heart does leave Ben with a number of problems. It certainly makes it hard to see why anyone would consult Dr Ben. Having already dismissed nutrition and the like as worthless – this in a population that doesn’t even average five fruit and vegetables a day- he now won’t be able to offer most drugs with confidence either.
But the problem goes deeper. For quite a time Ben and his even more radical followers have implied in their blog postings that we all inhabit a Manichean medical world – on the one side there is proper proven evidence based medicine (one of their favourite jokes was: What do you call an CAM treatment that has been proved to be effective? Medicine) and on the other is the fantasy stuff. A common line was – It’s OK if you want rely on “woo” but there is absolutely no reason why it should be available on the NHS.
So it will now be interesting to see how soon they will all be picketing the headquarters of GSK (recently fined huge sums for illegal marketing) along with other pharma market leaders, calling for some or all of their products to with pulled from NHS pharmacy shelves and representatives banned from contact with universities.
One obvious line of defence is to say just because many pharmaceutical products can be both worthless and dangerous that doesn’t automatically mean that the likes of nutrition is safe and effective. Logically that’s true, but this line of reasoning offers Ben and his followers little comfort.
If you assume both he and I are correct about big pharma, two things follow. First with drugs shown to be far less effective than claimed, there comes a dramatic shift in balance between risk from their inevitable, and often serious, side-effects and their benefits.
Arsenic could get a license if you paid the right people
So ordinary patients are being perfectly rational in opting for CAM because we can can say with certainty that taking new chemicals is going to be far more dangerous than taking vitamins, making dietary changes or using other controversial treatments like acupuncture.
Secondly pharma’s fudging has a less obvious but more damaging impact on the campaign by Ben and others to discredit CAM. If pharma can make drugs that are actually ineffective and dangerous pass the evidence based medicine tests, then those tests are pretty meaningless.
Given the vast marketing budget of of a pharmaceutical company it’s now clear that almost any substance – say arsenic or alcohol – could be given a copper bottomed evidence base. You just need to to test it on the right group of subjects, hide any failed results, pay senior academics to promote it and so on. Maybe CAM hasn’t a big enough evidence base because it hasn’t been paying the right people.
So what is to be done? Ben calls for the companies’ deadly fraud and deceit to be halted by ending to the current light touch regulation and replacing it with one that is independent, transparent and with meaningful powers to punish offenders. Welcome but also dreadfully familiar.
The irony is that it is the virulent evidence based medicine campaign against CAM waged by Ben and his allies which has reinforced the damaging notion that current medical treatment has pretty well got it right.
Treatments that aim to benefit industry rather than patients
Even if improved regulation weeds out the worst drugs, that doesn’t change the fact that we have outsourced responsibility for gathering the evidence base to industry. The result is that we get products that benefit industry. The question of how best to treat the elderly highlights what this means.
Right now elderly patients, don’t get evidence based medicine and under the current evidence based system they can’t do. Not just because of pharma fraud but because commercial considerations mean few drugs are tested on older people. Currently the only evidence that counts is what comes from a randomised controlled trial (RCT) involving one drug vs. a placebo for one disorder.
But older people are generally on a number of drugs because they have several disorder. So the results from younger healthier people treated with one drug at a time are applied to them. Understandable but not RCT evidence.
Interestingly this is the reverse of what happens when you try to test CAM using the RCT model. Drugs for the elderly are tested on people taking just one drug for one disease and then applied to people with lots of diseases taking lots of drugs.
With CAM the RCT system demands that treatments which normally involve several elements in the real world are tested using just one of them. So a CAM treatment for depression might involve cutting back on sugar and taking two grams of omega 3 plus a B vitamin supplement and exercising.
But to be evidence based in a way accepted by Ben an his allies you would have to test each of them alone. That fits the drug model but not the way CAM is done in the real world.
Evidence base system fatally flawed
But the current evidence based system isn’t just fatally flawed as far as the elderly on drugs or anyone else on CAM. Possibly even more damaging to the health of all of us are the trials that the system fails to run.
This is the inevitable result of relying on a commercial enterprise to do most of your evidence gathering. The trials that never take place are the ones involving promising vitamins or supplements or multiple approaches that aren’t patentable. We have a epidemic of life style disorders but no effective way of assessing which lifestyle changes work best and implementing them. Will Ben come on board to change that?