Drug firms driven by profit not safety

RECENT scandals involving drug safety suggest companies are motivated more by profit than the welfare of patients.

That subtle shift in motivation is undermining the basic notion of right and wrong. Moral ambivalence might well sum up the current situation.

In 2004 the Food and Drug Administration in the US and Harvard issued a severe warning about the dangers to health of Vioxx, Merck’s arthritic drug.

The report, based on non-clinical research warned up to 60,000 people could have suffered heart attacks as a side effect of using Vioxx. It was highly likely people had also died, it said. Merck wasted no time in rubbishing the research. Because the findings were based on medical files, it simply did not stand up.

Two weeks later Vioxx was withdrawn from market. Three years of clinical trials showed they were difficulties and that heart attacks were a side effect for certain groups.

Given it was just two weeks later that the company withdrew Vioxx, Merck had to have known that problems existed with the drug.

Given the circumstances surrounding the events it has to be assumed Merck executives were acting in the interests of its shareholders and not in the interests of patients when it reacted as strongly as it did.

Merck was technically within its rights in dismissing the FDA/Harvard research, but it must have known the claims were right. If it did not, then the communications systems in the group must have been pretty dire.

Since then Tysabri has been withdrawn from the market due to its links to the deaths of four patients in the US.

For thousands of sufferers of arthritis and for those with the awful Multiple Sclerosis disease these set backs are huge, because both drugs were and are hugely beneficial to the bulk of users.

It would be all too easy to dismiss the pharmaceutical companies as having become too focused on the bottom line at the expense of patient interests.

It looks however that we are in danger of crossing a fine line between patient welfare and the financial welfare of the companies who make life saving drugs.

Billions in profits are riding on the success or failure of such drugs as do the hopes of millions of sufferers from various diseases.

News this week that ibuprofen, a painkiller long considered one of the safest on the market, has been linked with heart attacks.

It is used to ease stiffness in joints for arthritis sufferers.

Nurofen is one of the best known brands based on this particular drug.

This is a huge blow to those suffering from arthritis and it raises further doubts about what is and isn’t safe anymore.

To keep this in perspective if the FDA was around at the time Aspirin was developed it would never have made it to the market. That’s hardly a convincing argument for relaxing control on the trialling and testing process required to ensure patient safety.

Given the need to find cures a balance has to be struck balancing the risks with the potential good a drug can do. Absolute safety can perhaps be sacrificed when some drugs offer great relief to the vast majority of patients.

However, far greater efforts are required to communicate the risks involved in the use of certain drugs if, as it seems to be the case, drugs are being brought to market with question marks hanging over their long term safety.

That is a significant change from where we were and is an issue that has to be addressed at the highest level.

It had been the case that it was safe to assume the drugs and the foods we consumed were life enhancing. If we sacrifice that basic principle we are sunk.