Patents, Patients, Profits and the Purple Pill

By Helen Jane Myrr

Patent-Kill-PatientPatent Kill Patient

Omeprazole: The Wonder Drug

The pharmaceutical industry can be very crafty when profits are at stake. I’m about to show you how, and why. Drug patents expire 20 years from the date of filing, at which point generic companies flood in and produce cheaper versions – cheaper because they haven’t had to go through the costly R&D process. No longer holding market exclusivity, the original drug’s price is forced down. In order to keep generic companies at bay, one of the tricks Big Pharma use is “evergreening”, a cunning tactic used in an attempt to extend a patent, and maximise revenue. Let me explain this concept with the example of omeprazole. This is a drug that is used for the treatment of stomach ulcers, reflux and heartburn – common medical problems. It is listed on WHO’s List of Essential Medicines and relieves the suffering of millions every year. It was cleverly introduced on to the drug market in the US in 1989 at a time when the fast-food industry was booming – and American appetites and waistlines were expanding. AstraZeneca (AZ), the drug’s manufacturer had hit the jackpot. As of 2000, AZ was raking in $6 billion a year for the drug, one third of its total revenue from all its drugs. But there was a storm brewing. In 2002, the drug was due to come out of patent, and lose its exclusive manufacturing rights. Generic manufacturers were lurking around the corner, ready to jump on the bandwagon and produce “me-too” drugs, driving the prices down: great news for the pockets of individuals and national health systems, but disastrous for AZs profits.

Extending the Patent: The Purple Pill

Nexium PillThe Purple Pill

 

But AZ had no intention of letting generic companies swoop in and diminish their profits. In 2001, just before the expiry of omeprazole’s patent, AZ launched a huge marketing campaign, for a drug named esomeprazole. This may sound familiar – that’s because it is. Esomeprazole (Nexium or “The Purple Pill”) is almost exactly the same drug as omeprazole, but with one clever difference. With a bit of chemical wizardry, AZ made a slight modification to omeprazole in a bid to extend its market monopoly: it got rid of one of the enantiomers. If you can remember back to your school chemistry lessons, enantiomers are a pair of chemical compounds that have exactly the same molecular and structural formula, however one cannot be superimposed on the other. Just think of your hands. They are exactly the same, made of the same material, but you cannot place one on top of the other in an exact fit. Omeprazole is what is called a racemic mixture, a mix of the left and right-handed version of the enantiomer. Esomeprazole is exclusively the right, a “single-enantiomer preparation”. By “proving” to regulatory authorities that the single preparation was therapeutically beneficial, AZ succeeded in prolonging the patent’s expiration date.

eantiomersEnantiomers have the same molecular and structural formula, but are non-superimposable on each other.

This may sound all well and good. And perhaps you would be right in thinking so. In some cases, one version of an enantiomer can be harmful, whilst the other is beneficial. This can be demonstrated by ethambutol, where one enantiomer is used to treat TB, and the other causes blindness. But this is not the case with the Purple Pill. AZ will argue until they are blue in the face that the single-enantiomer preparation is therapeutically beneficial, but studies demonstrate there is no dramatic difference between any of the various members of this drug class, and certainly no unique power of esomeprazole. Discouragingly it is not the scientific evidence, but the money that talks. $500 million was spent on Purple Pill advertisements in 2001, and it quickly shot to top of the charts, becoming a top 3-blockbuster drug in the US. Today it still makes $5 billion in global sales every year.

In other words, here is a reincarnated drug that has the same active ingredient as its predecessor, being launched onto the market to treat the same disease, all in the name of prolonging the patent and delaying the ever-impending threat of generics. Worse, it is the drug regulators, the people who are supposed to regulate the drug industry that gave it the go-ahead to happen. This kind of drug evergreening makes a mockery of scientific progress. To add insult to injury, the “new” drug was not just a bit more expensive than omeprazole; it was ten times more expensive! Thomas Scully, the head of Medicare and Medicaid publicly acknowledged that the drug was a waste of money, and went as far as to say: “Any doctor that prescribes Nexium should be ashamed of himself”. The drug continued to flourish.

Profit over Patient

 

In a way you actually have to commend AZ – it’s really rather clever. That is when you don’t look at the bigger picture. Things don’t look so good when you take a moral standpoint. Evergreening reduces incentives to produce new drugs. Extending patents for basically no good reason keeps the cost of drugs high by preventing cheaper generics being made, and this is where the damage is really being done. The real-life repercussions of evergreening can be demonstrated by the actions of Novartis with their cancer drug Gleevec. Disputes over its patent extension left cancer sufferers in developing countries such as India without affordable treatment. Novartis fought against the generic companies, effectively sentencing thousands of cancer patients to death. This is just one example – there are many more. I dread to think how many people have suffered, and died as a result of drug patenting laws. But there is a light at the end of the tunnel; people are catching on to this unacceptable practice of evergreening. Medicins Sans Frontieres (MSF) has launched a campaign against Novartis, ‘Stop the Attack on Generic Medicines,’ and it is gaining momentum.

 

Generic Novartis Campaign LogoThe Stop The Attack campaign by MSF brought attention to the issue of patents and evergreening

 

Whilst it is not my intention to tar all pharmaceutical companies with the same brush, this brings a home the very real reminder that for pharmaceutical companies, profit is number one. Patient interests come second to that, and this continues to leave people especially in vulnerable populations such as developing countries without medicines they need. Loopholes need to be sewn up to stop pharmaceutical companies evergreening their drugs, unless modifications represent some significant benefit. I am not arguing that pharmaceutical companies shouldn’t make a profit – without that new drugs will never be made, but drug companies do have moral obligations, and restrictions ought to be made by regulators on the act of evergreening and other patenting issues.

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