'Useless drugs' prof doubts pace of French reform

The French academic behind the best-selling "Guide to the 4,000 useful, useless or dangerous medicines" has conceded that the regulatory process in France is improving but warned that progress may be slower than most people would want.

In an interview with Scrip, Professor Philippe Even of the Institut Necker said that the since the regulatory reform began, "things are going in a much better direction". However, he cautioned: "I know the French bureaucracy too well. Even with new people at the ANSM [the French regulatory agency], and a new director of high quality and integrity, can they really change things quickly?"

Under the reform, the discredited agency AFSSAPS has been superseded by the ANSM, with a new director (Dominique Maraninchi), and as reported widely in Scrip, new rules on transparency and conflicts of interest have been applied to ANSM procedures, experts and staff.

Professor Even was also sanguine about any direct effect his new book might have on behaviour in the pharmaceutical arena. "I hope it has a real impact on patients and on politicians. But really I expect nothing will happen."

Possibly the most interesting aspect of the new book about the "cynical" French pharmaceutical industry and its wide range of mostly "useless" drugs is the fact that the same authors made these claims early last year with none of the furore that has greeted this latest tome.

In fact the authors themselves – Professor Even and Professor Bernard Debré, a surgeon who is also a member of parliament – have been saying this sort of thing for years. Professor Even himself pointed out that "this has all been known for some time".

Nonetheless, the "Guide to the 4,000 useful, useless or dangerous medicines", published on 13 December, has hit the headlines in a big way and again thrown the spotlight on an industry and regulatory system still reeling from the Mediator affair. The book has come under fire from all quarters, including industry and regulatory officials for being "excessive", alarmist and a mixture of fact and fiction.

The publicity surrounding the book's release, despite the familiarity of its claims, is attributable mainly to the fact that it is readily available on the news stands, and is being heavily promoted as a guide for patients on the quality of the medicines they are prescribed. Moreover, it analyses each drug individually, picking out some 58 "dangerous" products including cardiovasculars and drugs for osteoporosis.

By contrast, when the authors first made their views known, it was in a March 2011 report requested by the French government as part of the investigation into the Mediator affair, and containing few of the individual product analyses that appear in the book.

Report and book both paint a gloomy picture of a French market rife with thousands of useless drugs whose reimbursement wastes millions of euros in healthcare spending, marketed by a "cynical" domestic pharmaceutical industry that conducts next to no research of its own. The vast majority of originator drugs, they say, come from US, UK and Swiss firms, while French companies, with a few rare exceptions, produce only "me-toos" and other drugs of no real public health interest. Multiple drugs are approved and marketed for the same indications. The statins have shown no effect in primary cardiovascular prevention. 20% of French drugs are poorly tolerated, and 5% are "dangerous".

"Recycled and exploitative"

Reactions from the pharmaceutical industry and the regulator have been firm but muted, with neither apparently keen to enter into a media battle over the fine detail of the book's claims.

The industry association Leem said that the authors had been "recycling the same ideas for years", and now, with "massive media coverage", were exploiting the "wave of distrust" that had struck the healthcare sector in the wake of Mediator. It told Scrip the book would cause unnecessary alarm among patients and could lead them to stop taking their prescribed medicines.

ANSM, itself a creation of the reform that followed the Mediator investigation, defended the existence of several drugs for the same indication, saying that patients needed therapeutic alternatives. Professor Jean-François Bergmann, head of internal medicine at the Lariboisière hospital and vice-president of ANSM's approvals committee, told the doctors' daily Le Quotidien du Médecin that the book was a "pamphlet" containing "a mixture of truths and falsehoods".

Professor Even, of course, sees it differently. He told Scrip that the book was "a sort of sequel" to the report he wrote with Professor Debré. He suggested it would empower patients, giving them "scientific and objective" information so that they could discuss their medicines with their doctor, independently of any influence from the pharmaceutical industry.

As a measure of the book's popularity, he said it had already sold some 40,000 copies, which he attributed mainly to the "explosive" nature of the Mediator affair and the fact that it is now deeply engrained in the French psyche. "All of France knows about this", he said.

The book is not all negative. Professor Even said the industry has brought "a lot of good things as well as bad", and that it was not necessarily the drugs themselves that were the problem, but the way that they were used and reimbursed.

Reform goes in the right direction

So, is it all a storm in a teacup? Not really. Like the report, the book does identify some crucial failings, and hopefully will serve to focus public attention more closely on the major restructuring of the French drug regulatory system that is now underway.

In a move that tackles one of the Even/Debré book's most trenchant criticisms, the health technology assessment body, HAS, has revealed a new methodology for assessing the medical progress represented by new medicines (scripintelligence.com, 20 September). Under this mechanism, drugs will be recommended for (or refused) reimbursement using a "relative therapeutic index" comparing their value with that of products already on the market.