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Drugs placed on a watchlist by the French medicines agency:
Prescrire's analysis

At a press conference in Paris on 1 February 2011, Editorial Director Bruno Toussaint outlined Prescrire's position regarding the list of 77 drugs placed on a watchlist by France's medicines agency (Afssaps).

The depth of the disaster caused in France by Mediator° (benfluorex) is due in large part to withholding information, to silence, to non-communication and to the spread of misleading information; all leading to a massive – and in some cases excessive – loss of trust.

In reaction to this, and in order to prevent other disasters, it is important that from now on medicines, their advantages, their drawbacks, become the subject of a debate in our society. Because certain drugs are very useful for quality healthcare, and proper healthcare requires enlightened trust on the part of patients. For quality care, patients need healthcare professionals who advise them not to take Mediator° and healthcare professionals need patients who do not ask them for Mediator°.

The sudden calling into question of numerous medicines has left patients worried, has disrupted and complicated the work of doctors, pharmacists, nurses, etc. On the other hand, we have seen with Mediator° that silence and unquestioned routine can have consequences for patients that can add up to thousands of victims, and can be fatal. This calling into question must therefore be faced, even if it demands effort.

The publication of the watchlist of 77 drugs by the French medicines agency (Afssaps) on 31 January 2011 is a clumsy beginning, by an agency that is more accustomed to confidential dealings with pharmaceutical companies than to public communication with patients, an agency focused on regulatory issues and not on patient care.

The list is jumbled and, despite the time it took to publish it, it has been delivered without any real instructions attached, without any suggestions for action by patients and healthcare practitioners, without including, for each drug listed, analysis of the alternatives, or of the therapeutic advance (or lack thereof) represented by the drug, and without even citing the corresponding opinion or opinions issued by France's Transparency Committee (Commission de la transparence, which assesses the medical benefits of new drugs and advises on drug reimbursement).

Yet a drug's adverse effects must always be measured against its benefits, situation by situation, and according to the seriousness of the disease and the existence of alternative treatments.

The Afssaps' watchlist is a mixture. It includes:

1. Drugs that it is urgent to stop using because their risk-benefit balance is clearly negative, even if they still possess a marketing authorisation for France or for Europe:

  • quinine for cramps, with a risk of fatal adverse effects but no efficacy beyond that of placebo – no longer approved in the US for this indication since 1995!
  • pioglitazone, which can cause bladder cancer but has no advantage over other diabetes drugs;
  • nimesulide, which can cause serious liver damage but offers no advantage over other non-steroidal anti-inflammatory drugs (NSAIDs) which have fewer adverse effects;
  • bupropion, a member of the amphetamine family, which has no advantage over nicotine but is far more dangerous;
  • agomelatine, which has no proven efficacy against depression but the long-term risks of which are not well established;
  • and so on.

There is no cause to keep any kind of watch whatsoever over these drugs, there is cause simply to withdraw them from the market.

It is a waste of public resources to monitor drugs which ought in any case to be withdrawn from the market immediately.

2. Drugs that are of interest in a number of situations and for some patients, and which it would be useful to know better, such as:

  • imatinib;
  • deferasirox;
  • etc.

However the explanations, and more particularly the links for the reporting of adverse effects, are missing.

3. Standard drugs for some conditions, the interest of which is established, and the monitoring of which is linked to risks that are real but which must be weighed against a real benefit, and in the absence of a better alternative: methadone,  buprenorphine, levothyroxine.

If Afssaps truly wishes to place its priority on its role of protecting patients, it must:

  • warn patients, in a vigorous and well-reasoned manner, about drugs that are more dangerous than beneficial, without waiting for administrative procedures to be completed;
  • strongly facilitate reporting to France's regional pharmacovigilance centres of the possible adverse effects of drugs that require more study; while making sure that these centres have the means to properly process these reports;  and
  • make progress toward clear and effective communication with patients and healthcare professionals, without wasting time trying to protect  pharmaceutical companies and their products.

Whatever the case, patients who are affected by a drug on the watchlist should discuss with their doctor and pharmacist the real interest that drug has in their own case, and the alternatives to that drug.

Prescrire does not publish a list of drugs that should be withdrawn from the market. In the January issue of our French edition, we published a 34-page review of the year 2010, with a recap of which drugs are worth using, or not, from among the drugs studied and reviewed in 2010. One journalist from a nonmedical publication came up with the calculation that, in these 34 pages, Prescrire recommended that its subscribers not use some 32 drugs ("drugs to avoid"). There is however no exhaustive list of such drugs.

Sometimes we are asked why we do not keep an up-to-date list of the drugs that Prescrire recommends against using. It is because such a list is meaningless without explanations adapted to each situation, so that each healthcare professional and each patient can discuss them together.

We feel that our priority is to deliver information on an ongoing basis to healthcare professionals, leaving it up to them to choose the best moment to bring the matter up for discussion with the patient.

©Prescrire 11 February 2011

Médicaments sous surveillance : l’analyse de Prescrire, www.prescrire.org