TAMING THE DRUG MONSTER
- by Patrick Holford, Ph.D.
A major shake down is brewing for the pharmaceutical industry following increasing reports of manipulating drug trial data, doctors and the government to increase sales and profits. A recent issue of the New England Journal of Medicine published a correction on a study it published on Rofecoxib (Vioxx) – the now withdrawn pain-killer that is estimated to have damaged or killed up to 140,000 Americans – stating that increased cardiovascular risks were visible as early as four months into treatment, rather than the 18 months that Merck had claimed.
There are now an estimated 10,000 court cases outstanding against Vioxx manufacturer Merck – 400 of which are brought by patients in the UK who claim to have been damaged by the drug and not properly warned about the risks. The cost of legal actions to Merck has been put at between $5 and $50 billion.  As of April 2006, just six cases had been heard. In three, the plaintiffs were awarded damages running into millions of dollars. We don’t hear so much about this in the UK because plaintiffs here have been refused legal aid and insurers will not fund no-win, no-fee cases, so no cases can be brought.
This might sound like old news but this kind of manipulation of data is finally sounding big alarm bells within the medical profession. After all, commercial drug testing centres, funded by the company making the drug, are four times more likely to come up with favourable results than independent ones.  How can doctors know the science they’re being sold is free from spin?
Another shocking example recently emerged on a trial of the anti-depressant Seroxat. The summary at the start of the research paper, which is the only part most doctors read, claimed that Seroxat was ‘well tolerated and effective’. But when a team of independent scientists looked at the whole paper, they found this: ‘Out of 93 children given Seroxat, 11 had serious ADRs [adverse drug reactions] compared with 2 in the placebo group’.  Just how serious? ‘Seven of these children were admitted to hospital during treatment.’
This kind of deceptive reporting in what are supposed to be objective research reports is making the medical profession increasingly nervous. After all, this is what they rely on to practice safe medicine. On 8 July 2006, the British Medical Journal ran an editorial suggesting that drug companies should not be allowed to evaluate their own products. Instead, to get their drugs tested and licensed they would contribute to a central pot for independent, publicly-funded clinical trials.
But, of course, it doesn’t stop there. Clinical practice guidelines advise doctors on the drugs to use for various conditions. However, 80 per cent of the academics who write them have financial links with the companies whose products they are recommending.  
Then, of course, there’s the wining and dining of doctors. Drug companies in America spend around $15 billion a year on marketing, which is about half the amount they spend on research and development.  A big chunk of this is spent selling drugs to doctors who have to clock up a certain number of days of ‘continuing medical education’, paid for, you guessed it, largely by the pharmaceutical industry.
A recent article in the American Medical Association’s journal of ethics wants to put an end to this. ‘Only continuing medical education activities that are entirely free of pharmaceutical industry funding should qualify as education,’ they write. Continuing education should be funded by doctors, not drug companies, say the authors. And just in case you think these companies behave differently elsewhere, in the UK for instance, this is what the 2005 Parliamentary health committee investigation, The Influence of the Pharmaceutical Industry, found: ‘[it] buys influence over doctors, charities, patient groups, journalists and politicians, whose regulation is sometimes weak or ambiguous.’
In the wake of the Vioxx scandal, the US FDA, the agency charged with protecting the public from the dangers of drugs, has been heavily criticised for not responding fast enough to problems with drugs, for being too close to the drug companies and for not devoting enough attention and resources to safety once a drug had been licensed.
In May, a report by the US government’s General Accounting Office made damning criticisms of the FDA, saying that the agency ‘did not to have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings’. Not only was it slow to respond but ‘the agency’s entire system for reviewing the safety of drugs already on the market is too limited and broadly flawed’. 
The pharmaceutical industry begs to differ. A spokesman from the Association of the British Pharmaceutical Industry explicitly referred to the existing state of affairs between all the parties concerned – except for patients – and implied that as far as they were concerned, it was working fine. ‘The challenge is to acknowledge there is a contract between industry, regulators and health service which recognises that there is a trade-off between risks and benefits.’ 
With an estimated death toll of over 10,000 Britons every year from adverse drug reactions, and over 40,000 made seriously ill enough to require hospitalisation, that’s one hell of a trade off. 
‘Full spectrum dominance’ is the stated aim of the American military. It involves being ready ‘to defeat any adversary and control any situation across the range of military operations’. Not a bad description of what the pharmaceutical industry has achieved across the whole field of prescription drugs, from creating to selling. Besides dominating the clinical trials production line, the drug companies have also found ways of exerting control over researchers, medical journals, doctors and even patient groups. The industry’s strategy for maintaining their full spectrum dominance all the way down the drug chain is very simple – they pay for it.
‘Something is very wrong,’ writes Dr John Abramson of Harvard University in his brilliant and disturbing book Overdosed America, ‘with a system that leads patients to demand and doctors to prescribe a drug that provides no better relief and causes significantly more side effects’.
These recent and growing recommendations to sever the financial and information stranglehold big pharma has on medicine may, at last, provide a more level playing field in which it will become increasingly obvious that, for most chronic diseases, nutrition works better than drugs. It’s time we stopped swallowing what the drug industry tells us.
1. A Jack, ‘Master or servant: the US drugs regulator is put under scrutiny’, Financial Times, 7 January 2005.
2. J Lexchin et al, Pharmaceutical industry sponsorship and research outcome and quality, British Medical Journal (2003), vol 326, pp 1167-70.
3. E Marshall, ‘Antidepressants and children: buried data can be hazardous to a company's health’, Science (2004), vol 304 (5677), pp 1576-1577.
4. J N Jureidini et al, ‘Efficacy and safety of antidepressants for children and adolescents’, British Medical Journal (2004), vol 328 pp 879-83.
5. K Niteesh et al, ‘Relationships between authors of clinical practice guidelines and the pharmaceutical industry’, Journal of the American Medical Association (2202), vol 287, pp 612-617.
6. R Taylor and J Giles, ‘Cash interests taint drug advice’, Nature (2005), vol 437, pp 1070.
7. Spin Doctored: How drug companies keep tabs on physicians, online journal Slate, 31 May 2005.
8. M Kaufman, ‘FDA Is criticized over drugs' safety problems; response to approved medications cited', The Washington Post, 24 April 2006.
9. The Independent, 23 August 2005.
10. M Pirmohamed et al, Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients, British Medical Journal (2004), vol 329, pp 15-19.