When a pharmaceutical company develops a new drug, they naturally want doctors to know about it. Drug companies spend a lot of money marketing drugs to doctors, with the hope that these doctors will ultimately prescribe them to their patients. Naturally, drug companies like to present their wares in as positive a light as possible. As a result, drug companies marketing departments and their reps may use tactics that can put patients at risk.
Last week, the American Journal of Public Health published on-line a piece which highlighted some of the practices used to persuade doctors to prescribe a drug that may put health and even lives in jeopardy. Specifically, these tactics are:
1. Creating a new disease or reducing the threshold for disease
Osteopenia (loss of bone density not severe enough to be classed as ‘osteoporosis’) used not to be considered a disease entity, but now it is. ‘Pre-diabetes’ and ‘pre-hypertension’ are other examples of ‘conditions’ that are new and lower the bar in terms of treatment. For more on the trend for doctors to increasingly treat ‘pre-conditions’ and the issues surrounding this see here.
2. Encouraging unapproved uses
Drugs are usually testing is a quite-well defined population in terms of things like age and health history. Drug companies may, however, encourage a drug’s use in individuals in whom the drug has not been proven to be beneficial or safe.
3. Exaggerating safety claims
Making out the drug is safer than it is.
4. Exaggerating efficacy claims
Making out the drug is more effective than it is.
5. Basing the ‘benefits’ of a drug on ‘surrogate endpoints’
Drugs are supposed to prevent or treat illness (morbidity) and, perhaps, reduce the risk of death (mortality). Yes, many drugs are touted not for their benefits here, but benefits in terms of what are known as ‘surrogate endpoints’ such as blood sugar or cholesterol levels. However, we do have examples in the scientific literature where more intensive reduction of surrogate endpoints do not translate into true benefits. Intensive lowering of cholesterol with ezetimibe and simvastatin and more aggressive blood sugar control via medication are examples.
The authors of the American Journal of Public Health describe what they term the ‘inverse benefits law’, which states that benefits to harm ratio of a drug varies inversely with how extensively the drug is marketed. In other words, the more aggressively a drug is pushed at doctors, the more suspicious we should be of it.
According to Dr Howard Brody, one of the authors of this piece:
“Marketers are just doing their jobs. However, the reality is that for most new drugs, safety and efficacy are scientifically proven for only a small subset of patients. It’s time for physicians to take a stand and not prescribe them so readily.”
You can read more about this study here.
Applying the inverse benefits law should, I think, cause us to be particularly wary of cholesterol reducing drugs. Let us not be too surprised, then, that the science shows statin drugs to be not-very-effective at saving lives, while at the same time putting those who take them at risk of sometimes severe adverse effects.
1. Howard Brody and Donald W. Light. The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health. American Journal of Public Health 13 January 2010 [epub ahead of print]