Should we be weary of generic drugs?

This is the story of a lady who was blown away by generics. Or, more precisely, an umbrella, dislocated on the shoulder blades of his attending physician, who had refused to add "non-substitutable" (NS) by hand in front of the name of each of the drugs he had just prescribed. "I told him it wasn't possible. She went mad, called me a bastard, threatened to kill me, then kicked me with an umbrella," says this general practitioner who has been living in Grenoble for twenty-two years, who admits to fearing that "next time, it is not an umbrella but a knife."

The cause of such fury, all the more surprising as the shrew was followed by this 58-year-old practitioner for several years? "It is this untenable policy of generics that creates tensions with our patients," he laments. More and more of them are losing their temper." The incident happened on October 1. Still, the media were not aware of it. It is only reported on sites reserved for doctors, which are full of comments on this new "generic policy," also called "TPCG" (third party payment against generics), which has been in effect for four months now. to sum up: they find this policy stupid. "Three kinds of arguments come up all the time," explains Dr. Claude Bronner, vice-president of the federation of Doctors of France.

This is silly because it would be much easier to align the price of drugs whose patents have expired with that of generics: people could choose freely, without it costing Social Security one euro more. This is silly because patients can easily cheat: the prescriptions being all printed on a computer, nothing prevents them from adding themselves to the famous "NS" manuscript, which allows them to obtain the original drug, since the pharmacist can not compare with doctor's handwriting. And finally, it's silly because a lot of pharmacists refuse our scribbled "NS," patients come back to see us, and it costs two consultations instead of one at Social Security."

A lot of hassle, therefore, but for a noble cause: health insurance claims to have saved 1.4 billion euros in 2011 thanks to generics, the price of which "ex-works" is on average half the price. Original drugs (originator). And suppose it has decided to transform the simple "right of substitution" granted since 1999 to pharmacists in the authoritative abolition of third-party payment in the face of the refusal of a generic. In that case, it is also for a good reason: in constant progression since the appearance of the first generic drugs in France, at the start of the 2000s, their substitution rate slowed down and then fell from the end of 2010.

More and more patients refused cheaper generic drugs, and pharmacists had no way to force them to accept them. Forcing them to advance the price of the original drug - then reimbursed, but slowly, by their Primary Fund - seems to have been enough to bring them back to the right path: in barely six months, the rate rose from 71.4% to more than 80%, which begins to give credibility to the objective of 85% set for the end of 2012.

On the contrary, the sages of the Academy encourage their promotion by simply recalling that they are not an "absolutely true" copy of the princeps (evidence that no one denies) and by recommending that they not be prescribed "without taking into account the patient and his pathology, especially when it comes to drugs with a low therapeutic margin, such as anti-epileptics or those which treat hypothyroidism," which is also common sense.

However, these two remarks were enough for the collective pharmacists and the health insurance to howl at sabotage. "It's often like that with generics," observes Dr. Dominique Duping, general practitioner and blogger, who was very interested in the subject, without any reluctance towards generics, but never received any answers to the questions either. he was posing. "There is a kind of ideology: the simple fact of expressing a reservation or calling for a study is already considered an attack. Anything that could harm generics is systematically demonized". So let's live dangerously. Because our investigation nonetheless revealed some sufficiently obscure points to consider itself entitled to address them.

Of the Mediator, by a National Medicines Safety Agency (ANSM). In particular, concerning these famous "bioequivalence studies" that Dr. Duping has never succeeded in obtaining from the ex-Assays (French agency for the safety of health products), replaced last May, following the scandal. Capital studies: "They make it possible to ensure that the fate of the active principle in the body (absorption, distribution, metabolism, and elimination) is superimposable on the originator drug," recall the documents of the Assays which also give some details on their terms: "Only clinical trials necessary for the authorization of generic drugs (only one trial per MA application (marketing authorization); carried out for the most part in North America, South Africa, or India.", bioequivalence tests are carried out on groups of 12 to 36 healthy volunteers.

They compare the speed and intensity of absorption of the active principle for the generic drug and the reference specialty. These tests do not aim to verify the efficacy and tolerance of the generic directly, but to ensure that the blood concentrations are comparable after administration of the two products." This seems very good. Except also that checking the blood concentration a certain number of hours after the absorption of a generic, to check if it diffuses and is metabolized in the body in the same way as the originator (with a tolerance of 20% of the difference in both directions, all the same) in no way guarantees the chemical identity of their active ingredients. And except finally that "the effectiveness and the tolerance of the generic" (which these tests "do not verify directly," according to the own writings of Assays) are not negligible questions. This type of study, often carried out by organizations remunerated by laboratories, has only been published sparingly and never fully.

Many ordinary drugstore customers with no particular aversion to generics have noticed that some copies do not work as well as the original, including for benign reasons related to their conditioning. Yannick, mother of two boys with asthma, no longer knows how to refuse the generic of Ventolin: "Instead of being tapered in the shape of a mouth, the tip is an enormous cylinder. And the taste of the product is infamous, while the Ventolin has none. My boys don't want it".

Much more severe, the case of the elderly and all those who suffer from mental confusion, even slight: they could end up getting used to the packaging of a generic, often very different (packaging, but also size, shape, number, and tablet color) from that of the original drug. But the problem is that a single originator often has several generics, all different in their presentation but all with the same name, that of their molecule. The pharmacist, therefore, does not always give the same, and his most vulnerable customers find it increasingly difficult to navigate.

Some doctors do not hesitate to predict a health disaster. When we know the number of hospitalizations caused by a medication error (between 50,000 and 80,000 per year), we cannot prove them wrong—obviously supposed to take this kind of risk into account by not putting any chance on their customers. But the problem, again, is that they are not only financially incentivized to sell generics: since July 1, they are also exposed to sanctions if they do not reach the set sales target. By their local social security fund.

And some of them are incredibly (even illegally) finicky about exceptions to the TPCG rule granted by pharmacies. So many administrative hassles for them, which are added to the time lost in explaining the rule to their clients or arguing over the phone with the doctors who multiply the mentions "not substitutable." In short, nobody seems to find what they are looking for; and nothing proves that Social Security gains as much as it claims. It would undoubtedly have been simpler and more profitable to consider other solutions, for example, by allowing customers to pay the (sometimes minimal) price difference between originator and generic out of their own pockets. Or by saving money on other posts.

They were starting with the price of drugs which are, in both cases (originator and generics), much higher in France than in most other European countries. that the average cost per unit of a generic was 5 euro cents in the Netherlands, 7 in the United Kingdom, 12 in Germany, and 15 in France. Just by aligning itself with the United Kingdom, this study, therefore, concluded that "the savings would reach 1 billion euros, at the rate of 130 million savings for 1 cent reduction on the average price of the generic". Better than a track. Significantly since calming the climate of tension created around generics could also help reduce the consumption of sedatives.