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The missing leak

With counterfeit copies of Lipitor discovered in the UK's drug distribution chain, are regulatory agencies doing enough to make Europe's supply chain watertight?

missing leakCounterfeit copies of Lipitor, the world's most popular cholesterol-lowering drug, have been discovered in the UK's legitimate drug distribution chain.

It is the third time that fake prescription medicines have been dangerously close to reaching the British public via the lawful supply chain. After the most recent security breach, two announcements were made: one from the UK regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - and the other from Pfizer, the brand owner.

The first, from the MHRA, told us that it was 'thanks to the vigilance of the MHRA' that the counterfeits in the UK were found, and reassured the British public that the counterfeit Lipitor posed no immediate risk to patients.

The first part of the MHRA's statementis disingenuous, the second part is dangerous, and both parts are misleading. Yet the press and the public seem to have accepted the MHRA's press release as if it was written on tablets of stone.

Conversely, getting the right message to the wider world is a problem if you represent 'big pharma'. The press and public in Europe have grown sceptical and tend to read any warning from big pharmaceutical manufacturers with a jaundiced eye.

Pfizer's press release was, of course, a damage limitation exercise, but clearly the firm has reason to be truly concerned about the welfare of its consumers - it would be foolish not to. Manufacturers are right to be protective regarding issues of R&D, corporate strategy, marketing and other competitive issues, and the pharma industry is known for being tight-lipped.

Yet, when it comes to reputation, it is clear that the more transparent and open an organisation is, the more likely it will achieve a reputation for trustworthiness.

Pfizer, like several other manufacturers, has adopted a relatively open position on counterfeiting. It was prepared to quickly admit to identified problems and, furthermore, spend resources in both examining the extent of the product counterfeiting, as well as investing to combat it.

The MHRA, meanwhile, seems to be stuck in putting presentation before substance. The public might assume that the statutory regulatory agency of the Department of Health would be as transparent, well-inspected and accountable as any other vital law enforcement agency; but the public would be wrong.

The fact that the agency claims to be one of the best resourced and organised of its type in Europe should only give the public further cause for concern.

The recent history of counterfeiting and fraud in the UK (examples include Lipitor, Reductil and Cialis) reveals a lack of tight regulatory control there, as well as elsewhere in Europe. The British and other Europeans are not properly safe-guarded and the growth in EU membership has served to exacerbate this problem.

The US Senate is currently considering whether it should allow the importation of drugs and is being reassured by some Europeans that there is nothing to fear from European imports. The UK's MHRA takes this view. Can other regulatory authorities in Europe say otherwise?

Indirect dangers
With regard to the MHRA's claim that there is no danger to patients from the fake Lipitor, it is clear that drugs with wrong or missing active ingredients (in this case the patented Pfizer statin was completely absent from the counterfeits) will result in a failure to ameliorate a dangerous condition.

If small pharmacies buy fake, useless tablets in quantities sufficient to keep them stocked for six months, therefore providing regular patients with ineffective medication for that period, it is obvious that patients' conditions will not only fail to improve but will deteriorate.

In the case of a dangerously high level of cholesterol, the risks can be predicted clearly. How much of the counterfeit Lipitor in this case reached UK patients? No one, it seems, has attempted to find out.

Stakeholders
With regard to pharmaceutical safety, there are three main stakeholders. The first is the manufacturer, which always suffers when there is a perceived problem.

Cautionary tales that link parallel traders' imports with the infiltration of counterfeit medicines into Europe's distribution chain are often seen as the industry's attempts to protect its profit margins.

However, no one trusts big pharma, so no one listens to its concerns.

The second stakeholder is the person who provides the counterfeit medicine at the point of final sale, or who administers the medicine to a member of the public, or patient. These stakeholders have the least control over the distribution network and, as far as the national health system is concerned, are pushed to buy from the cheapest possible source - perhaps not the most prudent policy.

Yet, as health professionals, and with the media digging around the problem of counterfeit medicines, they would surely need to defend themselves if they had provided counterfeit medicines that caused harm. The question would quickly arise: did the pharmacist or doctor take reasonable steps to ensure that counterfeit medicines were not administered?

Assuming that every product is genuine might not be regarded as 'reasonable' for much longer.

Finally, the third, and most important, stakeholder is the general public, which remains largely unaware of the true picture. So the question is: how certain can these three stakeholder groups be that everything that could reasonably be done is being done?

The MHRA continues to congratulate itself and insist publicly that nothing is wrong with its actions. Yet, privately within the organisation, changes are underway. The MHRA's performance in recent years has been lacklustre; it is without a means of continuous `fresh air', it needs greater openness and transparency, it is scarcely accountable and lacks experience of running a major crime investigation.

Can we expect such a regulatory agency to tackle international organised crime? Certainly not without major fundamental change, and probably not without greatly enhanced resources.

The Lipitor matter only caught the MHRA's attention because it was warned by customs authorities in other parts of Europe that counterfeit Lipitor had been found elsewhere. As part of its routine requirement, the MHRA circulated batch details to wholesalers within the UK in case any had slipped through. However, by no means were all wholesalers in the UK advised - not much scope for self-congratulation there, you could argue.

The MHRA has come in for considerable criticism over recent years from government Select Committees, from various parts of the media and from members of the pharmaceutical industry.

Self-congratulation is no substitute for operational effectiveness, openness and integrity. The discovery of the fake Lipitor, as with previous detections, had nothing to do with proactivity on the part of the MHRA.

Strong criticism
The MHRA is a vital public body that is Responsible, among other things, for protecting the British public from exposu

2nd September 2008

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