Nigel Hawkes: Analysis
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For drug manufacturers, the hurdles constantly get higher.
Patients demand drugs that work effectively but which are targeted so precisely that they have no side-effects. The pharmaceutical industry would like us to believe that such products are possible, but there is hardly a drug on pharmacists’ shelves that does not have at least one undesirable side-effect.
Some of the cosiest and most familiar drugs are among the worst offenders. Take aspirin. We all do.
This centenarian is a genuine lifesaver, with a near-miraculous list of battle honours. It is effective against pain, but more aspirins are swallowed to protect against heart disease than headaches. Worldwide, more than 60 billion doses are taken every year.
Yet if it were invented today, aspirin could never be marketed. Its most dangerous side-effect is damage to the stomach lining, causing ulcers and bleeding. In under16s, it can trigger a rare but potentially fatal condition, Reye’s syndrome.
No drug with two such damaging side-effects would get far in today’s risk-averse world. Yet it is impossible to deny that, overall, aspirin has done far more good than harm. By expecting drugs to be completely safe we are throwing away potentially valuable products too readily. Whenever new safety rules are introduced, costs rise and it becomes less and less profitable to produce drugs that have a limited market.
So people with rare diseases suffer. “Orphan drug” designations, whereby companies are given incentives to develop less profitable drugs, may help a little but the cost pressures inevitably drive companies to seek big-market drugs, the only way they can get their money back.
The problem then is that a rare side-effect may loom large simply because of the huge number of people taking the medication.
It looks awful if thousands of people suffer side-effects and join in class actions, but if tens of millions are taking the drug the numbers suffering may be only one in a thousand or less. The other 999 are alleviating their symptoms and enjoying life.
Side-effects of drugs for treating depression are especially tricky to assess. There is evidence that they may increase suicidal thoughts, if not actual suicide, among adolescents. This may mean that teenagers plunged into gloom are lifted sufficiently by the medicine so that they see the possibility of controlling their lives once more. Thinking of suicide could be a sign of improvement.
If every drug is to be assessed for suicidal thoughts, it creates another barrier, another set of costs, and another reason for rejecting promising medicines because of a side-effect that may be tiny when compared with potential benefits.
The reductio ad absurdum of the search for complete safety is stasis. No new drug will ever be approved because fear has paralysed innovation. Everybody will lose. There will be no new medications, and we will be forced to fall back on those approved in earlier times when standards were lower. So by seeking perfect safety we will end up with drugs that are actually less safe, but familiar.
It’s enough to give you a headache. I’d recommend an aspirin.
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In the US it has been reported that death from adverse drug reactions is a major cause of death. The main problem is that drug companies are far more interested in the "bottom line" than in reporting the true position regarding the toxicity of their products. A number of drugs have been on the market to be withdrawn. Data was available but not reported to the registration authorities. A classic example is that of statins. To reduce cholesterol the mevalonate metabolic pathway was severely interfered with at its very root. This resulted in a reduction of CoEnzymeQ10 and other essential molecules essential for life. This was known back in 1990 (Merck actually patented a 2 combinations of Q10 with statins). It is recognised by the Canadian authorities with a data insert warning but not by the FDA and MHRA! In the US an epidemic of CHF (NHBLI) coincides nicely with the rise in statin sales ($multi-billions). Need I say more?
M. Cawdery, Portadown, UK
I work in healthcare and am all too familiar with this growing culture of risk-elimination instead of risk-management. Life is a risky business. It would be a great shame if the development of new drugs is affected by this aversion to risk. After all surgery is equally risky, yet there are waiting lists full of people willing to take that risk to improve their quality of life.
As for those "looking to sue", if healthcare professionals were more open about the risks and patients took more responsibility for treatment choices then surely any fear of litigation could be alleviated.
Sue, Newcastle-under-Lyme, UK
It is not the risk averse world that is the problem, it's the "looking to sue" world. If you told the 1,000 patients that the drug will alleviate the condition but 1 patient will experience side effects, they would all agree to taking the drug.
But the manufacturers are unwilling to take the risk that 1 person in 1,000 will sue them for damages and the ridiculous "penury damages" on top. And unfortunately in this day and age it is impossible to have a liability release; it would be thrown out because "the patient was desperate and had no real choice" or "did not understand what was being signed".
Bob Travels, Stevenage,
This article has omitted to note that the media is largely responsible for this unrealistic risk-aversion by the public. Hardly a week goes by without some media beatup - it should be called 'Drug Horror Story of the Week'. The impression is given that the particular drug will probably cause a nasty side effect, when in fact it is mostly a tiny percentage of patients who have had that side effect. The number of lives saved or improved by that drug is never mentioned. Media disingenuity about this issue equates to the fake moralising by Jerry Springer at the end of his shows.
Paul Francis, Brisbane, Australia