Doctors favour the costly drug Nexium for gastric reflux disease. But a drug that is basically the same can also be bought under a different name for a lower price and without a prescription.
A woman in her thirties has suffered a serious case of gastroesophageal reflux disease for over ten years. The disease had been treated with the proton-pump inhibitor Nexium for its duration. It is one of the most commonly used medications for gastric reflux disease.
Recently the patient received surprising news: the agent of Nexium is the same as in Losec, which does not require a prescription. The only difference is the price, as Nexium is much more expensive than Losec.
The woman was astounded. Why have none of the doctors told her that Losec and Nexium are the same drug? Why has she been made to pay for the more expensive alternative?
This patient is not the only case. Last year Nexium was prescribed to nearly 150,000 patients, which resulted in costs of over five million euro in social insurance money.
Origins of pricier options
How have we come to this? The British pharmaceutical company AstraZeneca launched Losec on the markets in 1989. Its agent is omeprazole, which controls the secretion of gastric acids. As gastric reflux disease is very common, Losec became a goldmine for the company.
In 2001 the company faced a major challenge. The patent of omeprazole was about to expire. AstraZeneca prolonged the patent's expiration through its army of lawyers, and it paid off. In 2002 the company launched Nexium.
Yet Nexium is Losec with different packaging. Losec is a so-called racemic substance, i.e. it contains both isomers of its agent, omeprazole. These isomers are similar, except for the fact that they are mirror images of each other, and only one of them controls the secretion of gastric acid.
In Nexium's case all that was done was that the Losec's agent isomer was used, named as esomeprazole and turned into a product. This way the company got a new patented drug, took it through the necessary clinical research and named it Nexium.
There was but one problem. Since Losec and Nexium are the same drug, how could it be proven to the authorities that Nexium is more effective than Losec?
Simple. In the clinical research 20 milligrams of Losec and 40 milligrams of Nexium were compared.
A round of calls with general practitioners and doctors of internal medicine reveals that most of them are familiar with the story of Nexium, and know that omeprazole and esomeprazole are practically the same thing.
If the doctor is aware of this, what makes them prescribe Nexium for the patient? Loyalty towards a familiar pharmaceutical rep? It is hardly in the patients' interest to spend their money.
The biggest loser
The biggest loser is research work on gastric reflux disease. Research groups dedicated to it are hard pressed to find in universities around the world. This is because pharmaceutical companies and doctors are satisfied with the situation. Proton-pump inhibitors result in significant amounts of money for pharmaceutical companies.
Doctors have an effective means to treating the symptom of gastric reflux disease. At the same time the real cause remains unknown.
In gastric reflux disease gastric acid moves continuously to the esophagus. Over time this harms the esophagus mucous membrane, which results in pain and a burning sensation. With some, repeated inflammation leads to the esophagus mucous membrane becoming similar to the intestinal membrane. This kind of change is referred to as Barrett's esophagus, and its transformed mucous membrane is prone to cancer tumors.
The few studies that have attempted to unearth the ultimate causes of gastric reflux disease indicate a much more complicated situation.
American researchers determined in 2009 that the flow of acid into the esophagus causes a strong immunological inflammation long before damage to the mucous membrane. This means that the mucous membrane injury may result from the inflammation instead of the chemical effect of acid.
Another recent discovery shows that gastric acid as such does not expose to Barrett's esophagus, but the main cause could be bile. The esophagi of some people is also filled with bile from the small intestine in addition to gastric acid. Yet it is not always clear based on external symptoms, which patients have simply gastric acid involved with their gastric reflux disease, and which ones also have bile.
It is problematic that most patients are treated with proton-pump inhibitors that are not anti-inflammatory drugs and do not hinder the rise of bile. They also have long-term effects, such as the embrittlement of bones, problems in the absorption of some vitamins, a possible risk of celiac disease and unexpected joint effects with other medication.
Patients deserve better medication or at least more active research, but medicine is troubled by stagnation.
Could some researcher somewhere believe that the true cause of the disease can be discovered and tackled?
Jani Kaaro – HS
Annika Rautakoura – HT
© HELSINGIN SANOMAT
Image: Sari Gustafsson / Lehtikuva