First marketed in 1974, Naprosyn (aka Naproxen) is still regarded by some doctors as a wonder drug. Bizarrely, it was recently listed as one of four drugs which can slightly reduce your chances of dying.

The argument in favour of Naprosyn is that although it can cause a stroke, internal bleeding or a heart attack it lowers inflammation in the body – which might help protect against cancer and heart disease. BUT a similar lowering of inflammation can be achieved with tiny doses of aspirin.

In 49 years we’ve learned nothing.

The following is an essay about Naprosyn taken from Dr. Coleman’s book ‘The Medicine Men’ which was first published in 1975 and is now available again.

By Dr. Vernon Coleman

Naprosyn/Naproxen

It is illuminating to study the ways different drugs currently being prescribed, have been promoted. To provide some idea of precisely how a new drug is promoted and how a promotional campaign can fail to provide the doctor (or the patient) with a fair account of the drug’s possible uses, I followed the launch of Naprosyn in Britain by the company Syntex. The drug is marketed in other countries under variations on the name naproxen, its generic name.

To judge the size and expense of the launch it is interesting to note that when I wrote to Syntex for details, instead of sending me a data card (which I did not get despite the new ruling which demands that all doctors should receive a data card) they sent me three expensively produced books about the product, one of 28 pages, one of 57 pages and one of 181 pages. As far as I could make out from all the information I was sent, no trials had been performed in general practice, but despite that fact Naprosyn was advertised to general practitioners as well as to specialist rheumatologists.

In some of the principal trials, Naprosyn was merely given to a group of patients and was not compared with other drugs at all. In one of these trials, forty-nine patients took the drug to begin with but at the end of the trial, only thirty-eight were still taking it. In a few trials, Naprosyn was compared with other drugs. In one of these trials out of fifty patients, only forty-one stayed in the trial until the end.

In one of the expensively produced brochures about the drug (which was very widely advertised in most of the medical journals) there is a copy of a paper entitled, ‘Comparative effects of aspirin and Naprosyn on gastric mucosa‘ written by three physicians from the University of Gothenburg in Sweden. For the research on which this paper was based, only twelve patients were used. In another trial, only six patients were used. This trial, performed by two doctors at a hospital in Milan, was published in the Scandinavian Journal of Rheumatology in 1973.

So much for the basic information about Naprosyn. Another point of interest is that the drug was effectively advertised to the general public, when in fact no ethical pharmaceuticals should be so advertised. The way this happened was that the drug was launched and described at a public press conference where medical journalists were given information about the drug at about the same time that doctors were learning about it. One result of this publicity campaign was that on a popular daily national radio programme, a science correspondent of the BBC and a disc jockey (neither of whom pretended to have or had any medical training at all) discussed the drug which was spelt out and praised. In the words of one commentator: “Its virtues were extolled; its toxicity minimised; its dosage enunciated; and the name of the company making it was announced.” Listeners were even advised to go to their family doctor and to ask him for the drug (which could only be obtained with a prescription). Later the medical director of the manufacturers was reported as having said that “one man has been in bed for three months and after taking the drug he was able to get up and walk to his workshop.” When reported in a newspaper this only made matters worse.

There was, needless to say, an immediate wide demand for the drug. Many patients rushed to see their doctor; and doctors, being busy and under pressure all the time, frequently agreed to hand out the drug only to find later that they then had the difficult job of explaining to patients why they had not been cured.

When the BBC was severely criticised for the way it promoted Naprosyn the Director General (in 1974) failed to see the point of the critical comments and seemed to think that those who had made the criticisms were worrying unnecessarily. Complaints made about Syntex, however, did stick. Complaints were made by the British Medical Association and by a Scottish professor, and even by another drug company. In defence, Syntex claimed that the problems arose because of the great interest of the press and clinicians, suggesting that the drug was so marvellous that they couldn’t hold back the enthusiastic support for it.

There was one interesting result of the attack. One medical journalist in a paper sponsored by advertisements wrote that the drug industry could claim credit for the incident as they had attacked the company involved. Which seems a rather roundabout way of trying to make friends and influence people.

A few months after the Naprosyn launch, side effects started to show up. According to one newspaper report the Committee on Safety of Medicines had received thirty cases of possible side-effects by March 1974 (the drug was launched just before Christmas). The Committee receives an extremely low percentage of all reports of side effects so the total number seen by that time must have been considerably greater. About half the reports related to intestinal trouble.

The Committee, frightened lest they worry the many patients taking the drug, responded cautiously. According to one correspondent of a national daily newspaper, the Committee did not want “a massive backlash which would frighten people who had taken the drug, upset doctors who had already prescribed it” and, politically perhaps the most important of all, according to the correspondent, sour relations with the drug industry. I find it disturbing that at this stage the Committee should apparently be concerned about its own relations with the drug industry.

In the spring of 1974, letters from unhappy prescribers started to appear in the British Medical Journal. On 23 March there were two letters headed ‘Naproxen (Naprosyn) and gastro-intestinal haemorrhage‘. In these letters, there were reports dealing with six patients. The first correspondent concluded: “We feel therefore that naproxen, cannot be added to the short list of safe drugs … but must be regarded as a potential gastric irritant.” The second correspondent wrote: “These side-effects seem very similar to those known to have occurred with phenylbutazone and other anti-rheumatic drugs and perhaps indicate that new drugs should be used with caution.”

A later writer pointed out that he had seen “gastro-intestinal intolerance in six cases with three having gastro-intestinal haemorrhage, necessitating emergency hospital admission for blood transfusion in two cases.”

Syntex seemed unabashed though they modified their campaign slightly. A revised data sheet had to be produced and when in May I attended a film showing given by a Syntex representative, I watched a short slide show for several minutes while listening to a tape-recorded rheumatologist explain how important it is to make sure that any new drug should have less side effects or be more efficient than drugs in use. The slide show did not mention Naprosyn and the drug was mentioned almost in passing by the representative, who merely pointed out that it satisfied all the criteria laid down in the film. In fact, it did not seem to me to satisfy any of the criteria.

Naprosyn was promoted as a drug suitable for patients with rheumatoid arthritis. There are now many drugs being used for this condition.

In a March 1974 issue of Update, a magazine containing many advertisements and sent to the general practitioners in the United Kingdom as a commercial educational aid, there was an article entitled, ‘Rheumatoid Arthritis and the General Practitioner‘. It was pointed out by the author of the article that two per cent of the adult population show evidence of rheumatoid arthritis and then he went on to say “Aspirin remains, in my view, the least unsatisfactory of all drugs advocated.” He also wrote: “The pharmaceutical industry has exploited the so-called anti-inflammatory property of certain other analgesics but insofar as it is of significance outside the laboratory this characteristic is possessed by aspirin as well.” The author of the article in Update also wrote: “The list of other possible drugs grows longer, but the advantage over aspirin for most patients in general practice has still to be shown.”

Despite all this evidence (perhaps because the evidence is swamped with advertising material saying the opposite) doctors do prescribe the branded products by the tonne. In a paper in the British Medical Journal in March 1974, it was reported that 125 patients with rheumatoid arthritis were asked what drugs their doctors had given them before referral to a hospital clinic and it was found that only 47 patients had received aspirin as the first drug, while 18 had not tried it at all.

About the Author

Vernon Coleman MB ChB DSc practised medicine for ten years. He has been a full-time professional author for over 30 years. He is a novelist and campaigning writer and has written many non-fiction books.  He has written over 100 books which have been translated into 22 languages. On his website, www.vernoncoleman.com,  there are hundreds of articles which are free to read.

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