UK government looks to tighten drug trial publication regulations

by Mark Benson on October 24, 2012

UK government looks to tighten drug trial publication regulations

The UK government is today looking at significant changes with regards to drug companies and the many trials which they carry out on a regular basis. This is an area which is very closely associated with diabetes as drug companies around the world look to improve treatments and indeed even introduce cures where possible. So what exactly is going on and what can we expect to change in the future?

Current obligations

The rules and regulations regarding the publication of drug trials in the UK, and indeed around the world, are perhaps not as strict and stringent as you might expect. Those results which are released into the public domain have an obligation to be accurate and give the “correct impression” but many will be surprised to learn that there is no lawful obligation for drug companies to release information regarding each and every trial into the public domain.

The idea that drug companies can literally “pick and choose” which elements of drug trials they release into the public domain and indeed which drug trials they actually discuss in public will surprise many people. While it would be unfair to tar each and every drug company with the same brush there is some scepticism with regards to how data is released and why sometimes not all of the data from any one particular trial is made public.

What strategies are used by drug companies?

There are many different strategies used by drug companies with regards to the publication of data associated with drug trials. We will now take a look at some of those mentioned by the UK authorities and some of those which will come under further consideration with regards to stricter legal obligations regarding publication.

Non-disclosure

If a drug company carries out a particular trial with regards to a specific illness or condition there is currently no obligation for this data to be released into the public domain. The likelihood is that some of the larger companies will attract more attention from the worldwide press but some of the private companies around the world may well be able to “bury this information” without any implications going forward.

The government is now looking at making it law for drug companies to release data about all of the drug trials which they undertake as well as the relevant results. In reality allegations of potential abuse regarding non-disclosure are likely to be few and far between but this does clear the way somewhat and make the industry more transparent.

Releasing partial data

One subject which has been mentioned time and time again by critics of the current drug trial regulations is the fact that by selective use of drug trial data it may be possible to show that a particular drug has a particular impact upon a very small cross-section of sufferers. This may include specific ethnic backgrounds, ages or the different sexes and may to some people give the impression that the trial itself was targeted at those specific individuals.

On the flip side of the coin, the data from these particular drug trials which is not released into the public domain make show instance of a negative impact or indeed no impact upon any underlying medical conditions when using these new drugs. The fact that drug companies are not obliged to issue all of the data does give rise to concerns regarding transparency.

Drug prices

When you bear in mind that the vast majority of drug trials carried out across the world will likely lead to nothing with regards to revenue and profitability for the underlying companies, perhaps we need to be aware of “failed trials”. On the face of it many of the new drugs which eventually reach the market may seem relatively expensive but if the company or companies involved have undertaken many trials, which have not been made public, this may give us a more realistic impression of the cost of arriving at this particular drug.

This particular element of the drug trial process is probably more positive with regards to drug companies because it will allow individuals and corporations around the world to truly understand the underlying cost of bringing a new treatment to the market. It may also help to highlight those companies which are perhaps more successful than others although whether this leads to a polarisation of future investment funding is perhaps another matter to take into consideration.

Drug trials and diabetes

If you look back over the years you will see there have been many drug trials with regards to diabetes as companies look for improved treatments and even a cure for the condition. This is an issue which is set to impact more and more people around the world as we move forward and indeed some experts believe that diabetes could eventually become the number one killer across the globe. Even in countries such as Zimbabwe, which have a chequered history with regards to health and medical issues, diabetes type II is already being discussed as more of a potential threat than even AIDS/HIV.

Ultimately the more transparently the drug industry becomes the better for all parties involved and hopefully we can all learn to move forward together to find resolutions to issue such as diabetes type II and diabetes type I. Whether the government will find significant resistance from the drug companies remains to be seen as ultimately the likes of the NHS are literally at the beck and call of these massive conglomerates.

Conclusion

For many years now there have been allegations and suspicions that some drug companies do issue data on a selective basis with regards to drug trials. Sometimes, inadvertently, this may well give the wrong impression with regards to a specific drug or a specific condition and can in some cases increase the optimism and hopes of individuals suffering from the likes of diabetes. The more transparent the government can make drug trials and the publication of underlying data the better for all involved in the long run but this is likely to be a significant battle because drug companies will fight tooth and nail to retain ownership and control of data gleaned from drug trials over the years.

Will the UK government ultimately be successful or will the power and influence of drug companies dumb down this potential change in regulations?


The opinions expressed in this article do not necessarily reflect the views of the DiabetesForum.com Community and should not be interpreted as medical advice. Please see your doctor before making any changes to your diabetes management plan.

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