Deadly Medicines and Organised Crime

by Peter Gotzsche

  In 2006, five FDA physicians reported that 185 thromboembolic events were linked to NovoSeven.89 In April 2011, two large studies concluded that there was no evidence that the drug prolonged life in any of its off-label uses, and in some studies of strokes and heart surgery, NovoSeven actually increased the risk of stroke and heart attacks.

  What galled Sidney Wolfe from Public Citizen the most was how Novo spent years pushing doctors to endorse off-label uses for NovoSeven and then issued a warning stating the drug could cause potentially fatal blood clots if used in patients who don’t have haemophilia. Novo promoted NovoSeven for soldiers from 2005 through 2007 with conferences and seminars that bore titles such as ‘Stop the bleeding! Bleeding management in military trauma care’, ‘Damage control resuscitation in Iraq’ and ‘Blood product effect on survival for patients with combat related injuries’.93 The company got off easy in terms of the amount of money they paid and no one went to jail.

  Novo denied wrongdoing,89 and in an interview on Danish radio in 2008, Mads Krogsgaard Thomsen stated that the experts knew that the drug worked, even though it could not be documented scientifically, and that this was the explanation for its extensive use.94 An interesting comment from a research director and a company that created a blockbuster out of hot air. This is how proponents of alternative medicine argue.

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  10

  Impotent drug regulation

  If the American people knew some of the things that went on at the FDA, they’d never take anything but Bayer aspirin.

  Len Lutwalk, FDA scientist1

  We don’t have safe drugs. The drug industry more or less controls itself; our politicians have weakened the regulatory demands over the years, as they think more about money than patient safety; there are conflicts of interest at drug agencies; the system builds on trust although we know the industry lies to us; and when problems arise, the agencies use fake fixes although they know they won’t work.

  I have great respect for the work conscientious scientists do at drug agencies. They have prevented many useless and harmful drugs from being approved and have withdrawn many drugs from the market. However, they work in a system that is fundamentally flaw
ed and where the benefit of doubt protects companies and not patients.

  This becomes clear if we compare drugs with cars. My 15-year-old car must be inspected biennially. If I turned up next time without the car but with 10 m of paper and told the inspectors they shouldn’t examine my car but the enormous pile of paper where all the results of my careful testing of my car were reported, they would think I was crazy.

  Isn’t it then crazy that we have accepted a system where this is exactly what the drug industry does? The clinical documentation for just three drugs can take up 70 m of binders (see Chapter 11). In my 10 m of paper, I could have hidden somewhere that the brakes were failing without the inspectors ever finding out. Similarly, court cases have revealed that drug companies may hide serious harms in their mountains of documentation that drug agencies will never find. The difference is that if my brakes fail, I might kill myself and perhaps a few others, whereas if a company hides lethal harms of its drug, it might kill tens of thousands of people. We should therefore be much more cautious about drugs than about cars, but we aren’t.

  Why did we create a system where the industry is its own judge when it so clearly doesn’t make sense? Testing drugs should be a public enterprise, but it isn’t, and industry money is everywhere; even our drug agencies are paid by industry and therefore compete about being most forthcoming.

  Another fundamental problem is that it’s a value judgement – not a scientific question – whether a drug is too dangerous compared to its benefits. What should we do about a drug that kills relatively few people while it improves the condition for many? There is no gold standard for such judgements, and regulators are no better than ordinary citizens at deciding where the line should be drawn. Unfortunately, regulators don’t consult with the public; they consult with people with vested interests: people from the company that owns the drug and specialists, many of whom have financial conflicts of interest in relation to the drugs they are evaluating. The regulators themselves may also have financial conflicts of interest, and even if they don’t, the benefits from a positive decision could be just around the corner in the form of a lucrative position in the company.