Woman reading instructions on pill bottle

The question, which we must always ask with medication, is whether the benefit outweighs the risk. This question applies to each drug and each individual person. Despite the wishes of academics and governments there is no protocol to fit all.

Sadly doctors and patients have become conditioned to believe that the benefits are virtually always greater and that harm is minimal. This is particularly the case with new medications. Much noise is made about breakthroughs in medicine and the importance of new drugs. The pharmaceutical industry in the US alone spends over $50 billion each year to discover new drugs.

So what do we get for our money?

A review of 315 studies between 1966 and 2010 shows that the effectiveness of medications is dropping! Yes, I know it seems hard to believe and it surprised me too at first look. The review looked at the effect of drugs compared to placebo across the decades. This included drugs for cancer, heart disease, infections and mental illness.

In the 1970’s the active drug was 4.5 times as effective as placebo. This dropped to under four times in the 1980’s, twice as effective in the 1990s and only 36% more effective in the 2000’s.

In simplest terms not only are newer drugs not any better; you could argue they are worse! There could be a number of reasons why this trend happens including the selection of people for trials and the severity of their condition. The reviewer’s felt that this did not fully explain the findings.

Often newer drugs are promoted on the basis of less side effects rather than better actual effect. This was the case with some of the drugs for high blood pressure in the 1980’s and also with the newer antidepressants.

To a degree this can be true but not always. Last week I wrote about the side effects of medications. In particular the way that effects may not be recognized as such and that some may only appear after many years.

With older drugs we are more familiar with the hazards and hence we may actually use them more judiciously.

The push for new drugs is largely industry driven. When patents run out the profitability of medications ends and hence companies look for new profit centers. This is commercially sensible. Indeed the companies would be acting against their best interests not to do this.

However governments, doctors and patients have been swept along with the notion that newer equals better. In over 25 years in medicine I have seen no major breakthroughs but a lot of ‘me too” drugs. In the late 1980s I was involved in a trial on the use of a new tablet for blood pressure. After enrolling a dozen people on the trial it struck me that the new drug was less effective than the old ones!

Newer medications for treating ulcers suppress more acid in the stomach than the older ones but they do not lead to better symptoms relief in most instances. And they can affect absorption of minerals leaving up to 25% of people low in magnesium.

The other issue is cost. A new anticoagulant, which costs US$8 per tablet, now has 40% of the cardiology market in the USA compared to 35% for the old drug warfarin, which costs a few cents per tablet. Whilst warfarin requires blood test monitoring and can be affected by other drugs, it has been safely and successfully used for many years.

The new drug does not “work” any better. It is not any safer. The advantage is that you do not need regular testing.  The cost differential is huge and in a health system with finite resources is this good use of those dollars? Another new anticoagulant has not been as successful as the risks of bleeding are actually increased.

Part of the problem is our worshiping of “evidence based medicine” and the randomized control trial. These trials were originally designed to establish safety, NOT to establish usefulness. Yet they have been turned into vehicles to promote drugs. (For those who want to go into the history go to Dr David Healy’s site).

And whilst there are thousands of drug versus placebo trials there are few drug versus drug trials to see what works better. This is hardly surprising. What company wants to go there!

And all of the above does not even include suppression of unfavorable trials, ghostwriting and the links between industry, researchers and governing bodies. Conflict of interest is more a way of life than an oddity.

So is it all doom and gloom? No. There is actually useful work being done on drugs to stimulate the immune system as a way of treating cancers. This could be a real breakthrough.

And we are fortunate to have medications to treat serious illnesses. However we overuse medications for lifestyle induced conditions (like high cholesterol) where lifestyle changes should be the treatment.

Our reliance on pills has gone too far when 46% of the American population takes a prescription pill (25% of 18 to 39 year olds take two!) regularly.  These pills have side effects, are expensive and have much less actual effect than we are led to believe. They are not the answer we believe them to be.

Houston, we have a problem. It is up to us to sort it out.