Interview: Counterfeit Lipitor

ìIf you had a blank sheet of paper, would you design it this way?î asked Pfizer's European senior director, Julian Mount, speaking to Pharmaceutical Marketing about the safety foibles in the European pharmaceutical supply chain.

Following yet another find of a batch of counterfeit anti-cholesterol Lipitor pills in the UK, the company has brought under heavy question the security of the country's supply chain - an area that comes under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA) - and has also marked out parallel trade as a ìweaknessî in the system.

The MHRA plans to take its investigation to new depths in a bid to discover how, first of all, a batch of Lipitor 20mg wormed its way onto the UK market and into patients' hands - leading Pfizer to issue a significant product recall at the start of August - only to be succeeded by a second find of a batch of fake 40mg Lipitor pills this week.

The latest batch, which was found when the MHRA was reportedly tipped off by a source in Holland, carried identification numbers that meant it was not for sale in the European Union. ìBut it was also a counterfeit batch,î a spokeswoman at the MHRA confirmed, ìand now we're in the process of investigating thatî.

The agency would not disclose the nature of the find that led it to believe the drugs were fake, and not simply an illegal import, for fear of compromising the ongoing investigation. However, it confirmed that the initial inquiry that was with Pfizer would continue and would ìtake into accountî the new information.

Fake Lipitor (40mg) was discovered at a small pharmaceutical wholesaler which, while it had a legal permit to conduct parallel trade, adds fuel to Pfizer's case against the practice of moving drugs around Europe for a profit.

The firm has expressed its disdain towards the practice of parallel trade and the security risk it believes is introduced to the supply chain in Europe by the `tampering' and repackaging of medicine packs.

ìWe are concerned about the breakdown of the supply chain within Europe,î said Julian Mount. ìIt tends to be a very partisan area because of the history of parallel trade and the previous financial `ping-pong' regarding the claimed benefits of parallel trade (PT). But this has moved on and it's no longer about money. What we're talking about here is patient safety.î

The fundamental question was, he said: ìWith 140 million packs of PT medicine in circulation in Europe annually, can we be sure - given the dramatic increase in the number of PT licences - that the system is as safe as it was? I think that's a very reasonable question to ask the MHRA.î

Pfizer is adamant that there is a clear link between disruption to intended distribution routes caused by parallel traders relocating and repackaging drugs, and opportunities for counterfeit products to reach UK wholesalers, and even patients.

ìWe believe that counterfeit Lipitor entered the UK supply chain through that medicines trading route [parallel trade], so we believe it went from a middle man to a primary wholesaler, and out to pharmacists. It is a typical example of the system breakdown.î

He added: ìWe have a lot of confirming evidence from various investigative agencies, such as the FDA and the FBI, that says if you're going to attack a system, you look for the weakest point and to Pfizer parallel trade seems like a very weak point to attack the European system.î

Some 18 months ago the MHRA went on record saying that the UK has the safest record for counterfeit medicines and the safest supply chain record in Europe ìand now we've seen four new incidences of counterfeit medicinesî, Mount pointed out.

Brand damage

It could be argued that Pfizer has been unlucky to be hit twice in almost as many weeks by fraudsters selling fake copies of Lipitor. Counterfeiters are likely to be attracted to this market segment and to this drug in particular - Lipitor is the world's best-selling pharmaceutical product and earns £6.6bn a year for Pfizer.

Aside from concern over patient safety - a recent presentation by Pfizer at the House of Commons reportedly saw fake pills being produced in a cement mixer and substances dried using naked light bulbs - there must be a considerable cost in repairing the damage caused by counterfeiters?

ìYes, it's our brand, our reputation, our image and our intellectual property. Essentially, you want to make sure that the Pfizer pack that ends up in the patient's hand portrays the right image for the company and that your intellectual property is reaching the patient as it should - as it left the factory, with safety seals so you know that's a good box of Pfizer medicines.

ìBut after it's been repacked, put in the boot of a car and driven between countries, is that really how you want your medicines pack to be delivered to patients? I'd say not.î

The company does not wish to become a scaremonger in terms of medicine safety, he added, as ultimately that would be contrary to its best interests.

ìBut what we are saying is that Pfizer doesn't want to be held to ransom for some middle man trading in its medicines and buying counterfeits, because when it comes to a product recall, we are the people who have to exercise it, we are the people who have to sit with the MHRA, we are the people in terms of brand damage and identity. If somebody is in the middle, corrupting the supply chain and selling counterfeit medicines, it's in our interest to try and help route that out.î

Opposing views

Pfizer's position was bolstered by the Association of the British Pharmaceutical Industry (ABPI) which highlighted parallel trade and internet pharmacies as ìtwo possible weak areas in the systemî.

However, MHRA spokesman Stephen Hallworth has said that the Lipitor recall - related to the discovery of the first batch, of 20mg pills - had no direct connection to the practice of parallel trade.

ìThis is all about organised crime and, as part of our investigation, we're trying to find out how these criminals penetrated the legitimate medicines supply chain,î he said.

Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies (EAEPC) representing parallel traders said there was no evidence of any safety issue on the parallel distribution chain.

ìIn the middle of June, one of our British members came across a box of original Pfizer Lipitor which had neither a batch number nor an expiration date on its outer package - it was fished out from a Portuguese importer.î Therefore, he noted: ìWe believe that by opening packs, parallel importers add a layer of safety to the supply chain.î

While the MHRA said it had taken note of Pfizer's proposals, it reiterated that it already had effective and comprehensive measures in place to tackle counterfeit medicines.

ìClearly no system is perfect and we can't say that this will never happen again but the MHRA remains at the forefront of international regulatory agencies and, due to the safeguards we have in place, the UK legitimate supply is difficult to penetrate with counterfeit medicines,î Hallworth noted.

Pfizer's Mount surmised: ìIt's not a disaster, but it is concerning enough for us to raise it and to want it looked at, and to ask is it really acceptable to have people in the middle [parallel traders] corrupting the supply chain? - and for what benefit?î

Talks between the MHRA and Pfizer are continuing.