Talk about pharmaceutical direct-to-consumer advertising!
Pfizer has just launched a commercial in British movie theaters warning about the dangers of counterfeit medicines illegally purchased online .
The commercial, slotted to be shown in 600 theaters across the UK, shows a middle-aged man spitting up a rat after swallowing a pill that arrived in the mail. (This alludes to the fact that some of the counterfeit drugs seized in the UK contained not API – but rat poison.)
According to an article in the Financial Times,
“The campaign reflects growing safety concerns – and commercial losses for the drug industry – caused by a rise in unregulated internet sales of medicines. It also marks an intriguing extension of the limits on advertising by drug companies to raise their public profile, in spite of tight restrictions on the marketing of prescription medicines to consumers. The film contains no reference to Pfizer’s medicines but shows the corporate logo alongside that of the Medicines and Healthcare Products Regulatory Agency, the UK watchdog that co-ordinates an increasing number of investigations and prosecutions of counterfeiters. It agreed to a pioneering partnership with the company.”
Well jolly good all around. Now let’s see if Pfizer will reach out to the FDA to pursue a similar program here at home. – and whether the FDA will have the courage to step up to the plate and accept the offer. That’s precisely the kind of pubic interest partnership the world’s biggest life sciences company needs in order to demonstrate that it’s heart – and pocketbook -- are in the right place. That it's in the public health business first and the selling drugs business second. And it’s just the kind of unambiguous, bold and innovative messaging the FDA needs to remind the American people – including some of our elected officials -- that drug importation is unsafe healthcare practice and unsound public policy.
To view the commercial, click here.
How big is the problem of counterfeit drugs? According to CNN:
“Many of the world's bogus drugs originate in Asia, particularly China, according to the U.S. Center for Medicine in the Public Interest. The fakes oftentimes are exported and change hands many times before reaching their unwitting consumers."These are criminal organizations that are manufacturing, distributing and selling counterfeit medicines," says Thomas Kubic, a former FBI agent and president of the Pharmaceutical Security Institute, a group funded by drugmakers. The growing trade has been fueled by the growth of Internet drug sales and the lure of lucrative profits. The Center for Medicine in the Public Interest expects global sales of fake drugs to reach $75 billion by 2010.”
The complete CNN story can be found here.
Perhaps the weakest link in the European chain of custody is parallel trade. In Europe, parallel trade (what we call “importation”) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and an independent wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.
In the EU there is no requirement to record the batch numbers of parallel imported medicines. So if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those who say we'll be getting "the same drugs as Canadians" are just plain wrong.)
In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record numbers of counterfeit recalls. In other words, drugs purchased from a British pharmacy by a Canadian internet pharmacy to fulfill an order from an American cutomer could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia.
Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
Pfizer has just launched a commercial in British movie theaters warning about the dangers of counterfeit medicines illegally purchased online .
The commercial, slotted to be shown in 600 theaters across the UK, shows a middle-aged man spitting up a rat after swallowing a pill that arrived in the mail. (This alludes to the fact that some of the counterfeit drugs seized in the UK contained not API – but rat poison.)
According to an article in the Financial Times,
“The campaign reflects growing safety concerns – and commercial losses for the drug industry – caused by a rise in unregulated internet sales of medicines. It also marks an intriguing extension of the limits on advertising by drug companies to raise their public profile, in spite of tight restrictions on the marketing of prescription medicines to consumers. The film contains no reference to Pfizer’s medicines but shows the corporate logo alongside that of the Medicines and Healthcare Products Regulatory Agency, the UK watchdog that co-ordinates an increasing number of investigations and prosecutions of counterfeiters. It agreed to a pioneering partnership with the company.”
Well jolly good all around. Now let’s see if Pfizer will reach out to the FDA to pursue a similar program here at home. – and whether the FDA will have the courage to step up to the plate and accept the offer. That’s precisely the kind of pubic interest partnership the world’s biggest life sciences company needs in order to demonstrate that it’s heart – and pocketbook -- are in the right place. That it's in the public health business first and the selling drugs business second. And it’s just the kind of unambiguous, bold and innovative messaging the FDA needs to remind the American people – including some of our elected officials -- that drug importation is unsafe healthcare practice and unsound public policy.
To view the commercial, click here.
How big is the problem of counterfeit drugs? According to CNN:
“Many of the world's bogus drugs originate in Asia, particularly China, according to the U.S. Center for Medicine in the Public Interest. The fakes oftentimes are exported and change hands many times before reaching their unwitting consumers."These are criminal organizations that are manufacturing, distributing and selling counterfeit medicines," says Thomas Kubic, a former FBI agent and president of the Pharmaceutical Security Institute, a group funded by drugmakers. The growing trade has been fueled by the growth of Internet drug sales and the lure of lucrative profits. The Center for Medicine in the Public Interest expects global sales of fake drugs to reach $75 billion by 2010.”
The complete CNN story can be found here.
Perhaps the weakest link in the European chain of custody is parallel trade. In Europe, parallel trade (what we call “importation”) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and an independent wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.
In the EU there is no requirement to record the batch numbers of parallel imported medicines. So if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those who say we'll be getting "the same drugs as Canadians" are just plain wrong.)
In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record numbers of counterfeit recalls. In other words, drugs purchased from a British pharmacy by a Canadian internet pharmacy to fulfill an order from an American cutomer could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia.
Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
