Are pharmaceuticals becoming more dangerous? In the wake of Merck’s Vioxx withdrawal, the case of the ill-fated drug test subjects in London and the growing threat of new diseases around the world, the drug industry is pinning its hopes on testing new drugs to help polish its tarnished image. But are drug tests, or the drugs themselves, ever safe? Dave Wong speaks to Synovate Healthcare Group Research Director Dr Stephen Godwin about the profitable but precarious world of drugs and drug testing.

 

Is there increased pressure on pharmaceutical companies these days?
Dr Stephen Godwin: There has always been high pressure on pharmaceutical companies. The difficulty the industry has is explaining how it makes big profits out of people who are ill. Morally, it’s a very delicate position to defend. However, the products they launch cost them an enormous amount of money. It’s difficult to set an exact figure, but it’s probably in the region of US$850 million just to get a product to launch. The problem is, they probably only have a one in five chance of making that money back. Seven out of ten will fail [to recoup their costs], one in ten breaks even, and two out of ten have to pay for the other eight. The pressure is all about the risk, and the risk is very high.

 

 

Is drug testing nowadays more dangerous than before?
It isn’t more dangerous. Recently there was the tragic incident involving the six men in England (in which all of them rapidly became seriously ill while testing a drug at Northwick Hospital, London), but the case is incredibly rare, and desperately bad luck. The outcome was in no one’s interest – the drug company that held it went out of business and Parexel, the company testing the drug, suffered a significant loss of confidence as well as revenue.

But it really is very, very rare. These men were only in the first phase of testing to determine whether the drug is safe – and this phase is usually very routine. This is the first case I’ve ever come across to have such an outcome, and the last time something like it happened was over 30 years ago. I think in this sense the pharmaceutical industry does a pretty good job.

 

 

Can drug trials ever guarantee that a 
drug is safe?
Of course not. In fact, they aren’t safe, in the sense that whenever you take a drug – with very few exceptions – it usually does things elsewhere in your body that the doctor did not intend. So a systemic drug (any drug that enters your system) inevitably does things that you don’t want it to do. Sometimes, these are beneficial – people didn’t know that aspirin thinned the blood and therefore reduced heart attacks – but most of them aren’t. Most importantly, we certainly don’t know what a lot of them do over the long term. You may have to take a drug for 20, 30, 40 years, say for diabetics drugs. Most formal clinical trials last 12 months or less.

 

Does extensive pharmaceutical testing actually prevent some drugs from getting to patients in time to benefit them?
In a lot of ways the drug companies are damned if they do and damned if they don’t. If they’re slow to bring a product out, they may be accused of not working to benefit suffering patients. And the same applies if they’re quick to bring a product out and someone dies. It’s never quite right in any given situation. With hindsight you can look back and say that the drug proved safe so why did it take so long to get to market – but then you get a case like Vioxx, and the big question becomes, how safe are these drugs?

There are very, very rare cases, such as the drug Gleevec, which cures a type of cancer called CML, which is a killing disease. This product was approved extraordinarily quickly, within four to five years, but this was a very unusual circumstance in which people were dying and there wasn’t anything else for them. And it has revolutionised the lives of those afflicted, saving them from what seemed an inevitable death.

 

Are drugs becoming more potent in order to combat more complex diseases?
Essentially, drugs are probably getting more dangerous. Nowadays there is a lot of talk about targeting drugs to particular enzymes or pathways in the body. That’s exactly what you want to do – a drug should ideally only recognise and affect one particular pathway where it should have its activity. The disadvantage here is, the more you target the system, the more you are assuming that by targeting it so closely you will change the illness for the good, and that the body will return to functioning normally.

The problem is that the body isn’t like that – it’s a lot more complex. We all have a lot of genes that aren’t used in our bodies. We only “express” about 3-4% of our genes – another 96% is out there and latent. If you affect something inadvertently, you can trigger something you really don’t expect. A worst case would be that you switch something on that you can’t turn off, effectively risking a cancer, which is uncontrolled cell growth.

 

 

Is there anything drug companies can do to get around this?
I’m not trying to paint a picture of doom and gloom, because there really are very few of these cases [where patients suffer unexpected catastrophic results] around. But the fact remains that the drug industry is trying to be extremely precise, hitting the exact enzyme, protein or molecule that is causing the problem in the body. Yet we don’t have any way to scan or screen people as well as we would like.

Take a disease like multiple sclerosis. We know what happens when you suffer from it, but we don’t know it’s cause; and so the treatments for the disease are relatively crude. However, there are some new drugs coming out that are much more precise, but it takes six to nine months or more before you can detect any progress in the patient. This puts you in a situation where a patient is receiving very potent drugs for a long period of time, and you still don’t know what the results will be.

 

 

What are the priorities of pharmaceutical companies today?
At the end of the day, drug companies are trying to discover drugs that cure disease and benefit humanity. They’re not doing it altruistically, but they are trying to do it ethically. They are, however, being forced to search for cures and treatments in areas (such as cancer or obesity) that are more and more complex – the “easy” diseases already have lots of drug treatments and terrible diseases like rheumatoid arthritis are far easier to manage, thanks to effective new drugs. Now, drug companies have to function and provide new drugs in areas that are much more difficult to resolve. sFor more 
information, contact 
Dr Stephen Godwin at 
stephen.godwin@synovate.com.