New Drugs and Indications in 2011. France Is Better Focused on Patients’ Interests After the Mediator° Scandal, but Stagnation Elsewhere

Outlook

Translated from Rev Prescrire February 2012; 32 (340): 134-140 New drugs and indications in 2011. France is better focused on patients’ interests after the Mediator° scandal, but stagnation elsewhere

The pharmaceutical market: do not assume that new products represent progress

In 2011, as in previous years, drug companies focused on a few therapeutic fields with high economic potential, such as cancer, cardiovascular disease and oph- thalmology (macular oedema and degen- eration), but therapeutic advance was rare. Among the 92 ratings for new drugs (with new brand names) and new indications analysed in our French edition in 2011, 53 (58%) represented “nothing new”. Only 3 drugs offered a significant improvement in patient management (“Offers an advantage”; see footnote c in the ratings table page 107). Boceprevir and telaprevir, two drugs representing an advance in the treatment of chronic he- patitis C, were marketed in late 2011 but examined in the January 2012 issue of la revue Prescrire (this issue p. 89-96). They will therefore be included in the review of new products in 2012.

Abstract transparency and to provide better Mostly false innovations. Among the information on drug-related harms. 37 new brand names, there were only G Progress in the pharmaceutical sec- European authorities showed no signs 11 new drugs. There were numerous new tor accounted for only a tiny propor- of similar improvements in early 2012. products masquerading as innovations, tion of the hundred or so new products mostly with harm-benefit balances that are and indications analysed by Prescrire G Drug companies continue to pro- no better, and sometimes worse, than those in 2011. About 1 in 6 new products had mote their products aggressively, of existing treatments. They included: more harms than benefits, while more which is not in patients’ best inter- – 2 recombinant forms of available drugs: than half of all new products provided ests. The medicalisation of life con- corifollitropin alfa, a recombinant FSH for no advantages over existing tinues apace, with more and more ovarian stimulation (Rev Prescrire n° 329), options. One worrisome trend was the direct-to-consumer advertising. and conestat alfa, a C1 esterase inhibitor for expansion of “umbrella” ranges for attacks of hereditary angioedema (Rev self-medication. G The Mediator° disaster was a wake- Prescrire n° 336); up call for French policy makers. In late – 4 old drugs recycled in new indications: G As in previous years, drug regula- 2011, several new regulations ser ving amifampridine (3,4-diaminopyridine) used tory agencies continued to grant mar- patients’ interests were adopted, for over 30 years in Lambert-Eaton myas- keting authorisation prematurely or including greater transparency and thenic syndrome (Rev Prescrire n° 329), the on the basis of inadequate evalua- better management of conflicts of inter- only drug to offer a slight advantage; fam- tion. This was especially true for pae- est, but as yet, with no major break- pridine (4-aminopyridine) used to poison diatric medicines, despite some limit- through in attitudes and procedures. birds in the early 1990s, and now marketed ed progress. Rev Prescrire 2012; 32 (340): 134-140. for multiple sclerosis patients with gait disorders (Rev Prescrire n° 337); quetiapine, G In the wake of the Mediator° disas- n 2011, Prescrire published independent a neuroleptic (Prescrire Int n° 121) approved ter, the French health authorities in Ianalyses of 371 new products and indi- charge of patient protection, including cations in its French edition in 2011. the drug regulatory agency, finally They included 37 new products with new a- reacted by withdrawing many old brand names, 20 line extensions, and In addition: analyses of indications for existing drugs with more follow-up, generic drugs, changes in labelling, drugs with negative harm-benefit bal- 31 generic drugs with fancy new brand miscellaneous modiﬁcations, brand name changes, and ances and made an effort to increase names (“unmasked copies”) (a). market withdrawals.

PAGE 106 • PRESCRIRE INTERNATIONAL APRIL 2012/VOLUME 21 N° 126 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only. since 1997 in the United States and the UK; products or indications (16 out of 92, 17%) tile dysfunction (Rev Prescrire n° 330), few prucalopride, a stimulator of gastrointesti- were rated “Not acceptable” by the Prescrire improvements in the mode of adminis- nal motility known since the late 1990s, team, meaning the drug should simply tration were made in 2011. In particular, was approved for chronic constipation in not be used in the indication in question the intranasal form of fentanyl (Pecfent°)for women (Prescrire Int n° 116); (see note d in the ratings table below). cancer pain is no better than existing – 3 “me-toos”: eslicarbazepine, an oxcar- Healthcare professionals must remem- options (Prescrire Int n° 123). bazepine me-too for partial epilepsy (Rev Pre- ber, and notify patients, that marketing scrire n° 331); histrelin, yet another authorisation does not necessarily mean Expansion of umbrella ranges, gonadorelin agonist for prostate cancer that a drug has a favourable harm-bene- despite the dangers. More umbrella (Rev Prescrire n° 336); and velaglucerase alfa, fit balance. See also the inset on page 108. ranges were marketed for self-medication a virtual copy of imiglucerase, for type 1 in 2011, including “Actifed°” (Rev Prescrire Gaucher’s disease (Rev Prescrire n° 331). Treatment convenience: don’t rely n° 332 and 338), “Doli°” (Rev Prescrire on fixed-dose combinations. Prescrire’s n° 331), and “Vicks°” (Rev Prescrire n° 338), Drug regulatory agency assessment analysis of new products also covers con- along with the prescription-only “Alko°” procedures: uncertainties and inade- venience of use. product line (Rev Prescrire n° 337). Yet quacies. In 2011, Prescrire highlighted Drug companies stress the conven- these brand names hide a range of very dif- weaknesses in the pre-marketing evalua- ience of fixed-dose combinations, yet ferent active ingredients, creating a risk of tion of several drugs approved by regula- such products do not always allow fine confusion for patients. These products tory authorities: dose adjustment and can carry an should neither be prescribed nor dispensed. – too few data to reliably determine the increased risk of adverse effects and inter- harm-benefit balance (“Judgement actions (Rev Prescrire n° 332). Paediatric drugs: some progress, but reserved”, see note e of the ratings table The fixed-dose combination of aciclovir inadequate assessment and poor below); and hydrocortisone for labial herpes has a packaging. The number of medicines – misuse of statistics, including inherent- negative harm-benefit balance (Prescrire Int authorised for paediatric use has risen ly unreliable subgroup analyses in trials of n° 119). The other combinations market- slightly since the Paediatric Regulation docetaxel as adjuvant treatment for breast ed in France in 2011 provided no advan- was adopted in the European cancer (Prescrire Int n° 117); tages over existing options: amlodipine + Union. Unfortunately, the packaging is – dangerous leniency, particularly the telmisartan in hypertension (Rev Prescrire often substandard (see in a coming issue) approval of a monoclonal antibody, deno- n° 335); dutasteride + tamsulosin in benign and premarketing assessment is often sumab, to prevent osteoporotic fractures, prostatic hypertrophy (Rev Prescrire n° 332), inadequate. This is the case for abatacept in despite its numerous adverse effects (Pres- and ibuprofen + codeine for moderate pain juvenile chronic arthritis (Rev Prescrire crire Int n° 117). (Rev Prescrire n° 332). n° 328) and atazanavir for HIV infection Apart from some welcome oral solutions (Prescrire Int n° 118). Approximately one in six new drugs for paediatric use (see below) and an A few paediatric drugs, despite their lim- best avoided. In 2011, about 1 in 6 new orodispersible form of vardenafil for erec- itations, represent significant advances:

Prescrire’s ratings of new products and indications over the last 10 years (a)

Prescrire's rating 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Bravo 0 0 001100 0 0 A real advance 4 4 011200 1 0 Offers an advantage 9 5 6 4 8 14 6 3 3 3 (c) Possibly helpful 18 23 12 20 31 27 25 14 22 13 Nothing new 35 34 41 38 69 79 57 62 49 53 Not acceptable 6 (b)7 (b) 7 19 17 15 23 19 19 16 (d) Judgement reserved 0 6 428396 3 7 (e) Total 72 79 4 84 135 141 120 104 97 92 a- For reason of space this table only shows the results for – bendamustine in second line therapy of indolent non- – moxifloxacin in community acquired pneumonia and the last 10 years. The previous years’ results (1981 to 2001) Hodgkin’s lymphomas and multiple myeloma (Rev Pres- skin infections (Rev Prescrire n° 327 + 328) ; can be found in Prescrire Int n° 58. crire n° 338) ; – omalizumab, a weak dosage in severe persistent asth- b- Including two jointly marketed products. – bleomycin in malignant pleural effusion (Prescrire Int ma (Prescrire Int n° 121) ; c- The drugs were: n° 122) ; – prucalopride in women with chronic constipation (Pres- – denosumab in postmenopausal osteoporosis (Prescrire crire Int n° 116) ; – collagenase clostridium histolyticum in Dupuytren’s Int n° 117) ; – Botulinum toxin type A for migraine (Prescrire Int contracture (Prescrire Int n° 122) ; – denosumab in prostate cancer related bone loss (Rev n° 122). – mesalazine in ulcerative colitis and Crohn’s disease in Prescrire n° 329) ; e- The drugs include: children (Prescrire Int n° 119) ; – docetaxel in adjuvant therapy for breast cancer (Prescrire – abatacept in juvenile idiopathic arthritis (Rev Prescrire – tocofersolan in vitamin E deficiency (Rev Prescrire Int n° 117) ; n° 328) ; n° 333). – erlotinib in maintenance therapy of non-small cell lung – alglucosidase alfa in late Pompe disease (Rev Prescrire This table shows new products (other than generics) cancer (Prescrire Int n° 120) ; n° 336) ; and new indications proposed by drug companies to physi- – exenatide in type 2 diabetes in combination with glita- – bevacizumab off-label in age-related macular oedema cians and pharmacists, for use in hospitals and/or the com- zones (Rev Prescrire n° 328) ; (Rev Prescrire n° 331) ; munity; and, from 2005 onwards, line extensions (new – fampridine in multiple sclerosis and walking disorder – cabazitaxel in advanced prostate cancer (Prescrire Int dose strengths, new form/presentations of existing drugs) and (Rev Prescrire n° 337) ; n° 123) ; products for self-medication, rated in our French edition La – lanthane with more follow up in dialysis patients with – quetiapine (Xeroquel LP°) in prevention of depression revue Prescrire. A given product is counted several times if chronic kidney failure (Rev Prescrire n° 329) ; in bipolar disorder (Prescrire Int n° 121) ; it was rated differently in its different indications. – lanthane in non-dialysis patients with chronic kidney – rituximab in maintenance treatment of follicular lym- d- The drugs were: failure (Rev Prescrire n° 329) ; phoma (Rev Prescrire n° 338) ; – aciclovir + hydrocortisone in herpes labialis (Prescrire – methotrexate 10 mg, a strong dosage in rhumatology – sunitinib in pancreatic neuroendocrine tumours (Rev Int n° 119) ; (Rev Prescrire n° 331) ; Prescrire n° 337).

PRESCRIRE INTERNATIONAL APRIL 2012/VOLUME 21 N° 126 • PAGE 107 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only. Outlook A look back at new drugs and indications in 2011

(EMA). Drug companies that develop and Drugs best avoided yet still on the market in early market such products enjoy certain advantages, including market exclusivity. None 2012 of the 6 orphan drugs examined by Prescrire in 2011 represented a real breakthrough. Many drugs that have more harms than – iron dextran, due to a higher risk of benefits are still marketed in France, and hypersensitivity than with iron sucrose Generic drugs with uneven thera- in some cases, for several decades. The (Rev Prescrire n° 335); peutic value. In 2011, Prescrire examined following drugs were examined in Pres - – meprobamate is still contained in certain the harm-benefit balance of 27 generic crire in 2011, in order of publication: products in France (for gastrointestinal drugs marketed in France. – nimesulide, a nonsteroidal anti-inflam- disorders associated with anxiety, and Ten of these drugs are useful in certain si- matory drug (NSAID), because of the risk premenstrual syndrome), despite a risk of tuations: intradural baclofen for some cases of liver damage (Prescrire Int n° 116); severe cutaneous and haematological of severe chronic spasticity (Rev Prescrire – antihistamine antitussives, because of adverse reactions, and a withdrawal syn- n° 332); clobetasol, a potent topical corticos- their sedative and antimuscarinic effects drome (Prescrire Int n° 123); teroid for some skin conditions (Rev Prescrire (issue 329 p. 179); – bupropion, an amphetamine derivative, n° 328); dacarbazine for some cancers (Rev – dronedarone, an antiarrhythmic drug, and varenicline, an acetylcholine receptor Prescrire n° 330); epoprostenol for pulmonary due to a risk of liver damage and cardio- partial agonist used for smoking cessation, arterial hypertension (Rev Prescrire n° 328); vascular disorders (Prescrire Int n° 122); mainly because of cardiovascular and letrozole in breast cancer (Rev Prescrire n° 333); – terpenes, due to their neuropsychiatric neuropsychiatric disorders (Rev Prescrire levetiracetam for various forms of epilepsy adverse effects (including seizures), espe- n° 329, Prescrire Int n° 124); (Rev Prescrire n° 336); meropenem (Rev Prescrire cially in young children. In 2011, some – quinine for cramps, because of a risk of n° 337) and teicoplanin in severe infections medicines for children, mainly suppositories, haematological disorders, cardiac arrhyth- (Rev Prescrire n° 331), modafinil for nar- still contained terpenes. In late 2011, the mia and hypersensitivity (Prescrire Int colepsy (Rev Prescrire n° 329); and valsartan French drug regulatory agency contraindi- n° 115); (with or without hydrochlorothiazide) for cated their use in suppositories for children – mequitazine, a “sedative” and “atropinic” hypertension, heart failure and recent under 30 months (Rev Prescrire n° 340); antihistamine used in allergies, carries a myocardial infarction (Rev Prescrire n° 336). – trimetazidine, marketed for angina, higher risk of cardiac arrhythmia than Many other generic drugs are best avoid- dizziness, visual disorders and tinnitus, other antihistamines. In 2011, the French ed, including milnacipran in severe depres- carries a risk of extrapyramidal disorders, agency simply placed mequitazine on the sion (Rev Prescrire n° 338), nicorandil in falls and thrombocytopenia (Prescrire Int list of controlled substances (Rev Prescrire angina pectoris (Rev Prescrire n° 33), and n° 115). In 2011, the French regulatory n° 337) rivastigmine in Alzheimer’s disease and in agency triggered a referral to the Euro- – ropinirole, a dopamine agonist used dementia associated with Parkinson’s dis- pean Medicines Agency; for restless legs syndrome (Prescrire Int ease (Rev Prescrire n° 337). – pholcodine, an opioid antitussive, n° 115); Marketing applications for generic drugs because of concerns over a risk of aller- – orlistat for weight loss: its adverse give regulatory agencies an opportunity to gy to muscle relaxants used during anaes- effects and interactions largely outweigh reassess the value of the originator drugs, thesia (Rev Prescrire n° 331). In 2011, the a marginal and transient weight loss (Rev and to withdraw those with a negative French agency simply ruled that this drug Prescrire n° 338); harm-benefit balance. Apparently they are should be available by prescription only, in not taking advantage of this opportunity. order to limit its use (Rev Prescrire n° 333); Since late 2011, some of these products – oral and nasal vasoconstrictive decon- are no longer reimbursed in France, gestants (ephedrine, naphazoline, including those based on dronedarone, Patient protection oxymetazoline, phenylephrine, pseudo - nimesulide and quinine (for cramps). While ephedrine and tuaminoheptane), because the measures limit the consumption of In 2011, the French health authorities of a risk of life-threatening cardiovascular these drugs and, thus, the number of finally started to react, by protecting disorders (myocardial infarction, arrhyth- patients exposed, they send a mixed mes- patients from several drugs that have more mia, hypertension). In 2011, the French sage to patients. Simply withdrawing them harms than benefits (see page 110). agency simply demanded a modification from the market is the most effective solu- in the Summary of Products Characteris- tion. Market withdrawals: the most tics (SPC) (Rev Prescrire n° 335); ©Prescrire effective measure, often taken late. Drug reassessment can result in measures that support patients’ interests, such as market withdrawal of drugs with – mesalazine for children with inflam- tension, but the packaging represents a a negative harm-benefit balance. matory bowel disease, although the pack- potential source of errors, the drug is In 2011, the French drug regulatory aging is not suitable for all children (Pre- expensive, and access is restricted (Rev agency finally started to withdraw some of scrire Int n° 119); Prescrire n° 329); and valsartan ready-to-use these products, many of which had been – oral pegylated vitamin E (tocofersolan) oral solution, reimbursed (the standard on the market for decades: avoids the need for painful injections of angiotensin II receptor blocker for children – buflomedil, a vasodilator marketed for vitamin E (Rev Prescrire n° 333). in 2011) (Rev Prescrire n° 327, n° 338). over 30 years (Rev Prescrire n° 327, n° 329); Some other drugs approved for chil- – the fixed-dose combination of clorazepate dren provide minor advantages: Orphan drugs: in decline. According + acepromazine + aceprometazine, available – oral bosentan solution for pulmonary to European regulations, “orphan drug” for nearly 40 years in insomnia (Rev Pres- arterial hypertension (Rev Prescrire n° 329); status is granted by the European Com- crire n° 335); – latanaprost (after beta-blocker eye drops) mission for medications aimed at treating – oral ketoconazole, an antifungal drug that for ocular hypertension (Rev Prescrire n° 333); patients with rare diseases, based on the can cause severe liver damage (Rev Prescrire – oral suspension of losartan for hyper- opinion of the European Medicines Agency n° 335);

PAGE 108 • PRESCRIRE INTERNATIONAL APRIL 2012/VOLUME 21 N° 126 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only. – some products based on meprobamate, – dronedarone: liver damage and heart used for more than 40 years in alcohol problems (Prescrire Int n° 120); Questioning French withdrawal, and the fixed-dose combina- – somatropin: increased mortality due to tion of meprobamate + aceprometazine, used cerebrovascular disorders and bone drug policy: a few timid for nearly 50 years in insomnia tumours (Prescrire Int n° 117); steps taken in 2011 (Prescrire Int n° 123); – strontium: numerous cardiovascular and – a fixed-dose combination powder cutaneous adverse effects, etc. (Prescrire Int In 2011, the rationale for French drug (Paps°) of salicylic acid + terpenes (camphor, n° 117); policy was challenged by the Mediator° levomenthol, lavender essential oil) + bismuth – dasatinib: pulmonary arterial hyperten- disaster (Prescrire Int n° 121). + zinc + boric acid, marketed for nearly sion (Prescrire Int n° 120). In March 2011, Prescrire published 50 years for pruritus (Rev Prescrire n° 338); However, other important information 57 proposals on its website (english. – products based on pioglitazone, an anti- is buried in the summaries of product prescrire.org), based on evidence accu- diabetic drug (withdrawn in France but characteristics (SPCs), patient leaflets, and mulated over the years, aimed at pre- maintained by the European Commission the EMA’s “steps taken after authorisation” venting similar disasters in future and at on the advice of the EMA) (Rev Prescrire or “assessment reports”: refocusing national drug policy on pub- n° 335). – tianeptine: cutaneous disorders were lic health and patients’ real needs Other welcome withdrawals included: added to the SPC, but they are not all men- (Prescrire Int n° 116, 121 and 123). – combinations based on dextropro - tioned in the 2011 patient leaflet (Rev A new law on human medicines was poxyphene, marketed for more than Prescrire n° 337); passed in France on 19 December 45 years for pain relief: withdrawn from – natalizumab: data on infections (including 2011. the market following a European reassess- progressive multifocal leukoencephalopa- Some of its measures will serve ment (Rev Prescrire n° 327, n° 328); thy) and hypersensitivity were released in patients’ interests: – celecoxib in familial adenomatous poly- a report from the French Pharmacovigilance – better management of conflicts of posis: European marketing authorisation Committee (Prescrire Int n° 122); interest within government agencies; was withdrawn because the company – thalidomide: data on hearing loss were – more transparent reporting of com- failed to provide supporting data (Prescrire provided in “steps taken” (Prescrire Int mittee meetings; Int n° 121); n° 124). – stricter regulation of off-label pre- – becaplermin (Rev Prescrire n° 335), drotreco- scription; gin alfa (Rev Prescrire n° 338) and sitaxentan – stricter regulation of medical devices. (Rev Prescrire n° 328), all withdrawn at the Aggressive drug promotion request of the drug companies, not the reg- However, several important meas- ulatory agencies. Faced with the pervasiveness of drug ures were left out: promotion by pharmaceutical companies – development of clinical research more Some decisions supported patients’ and weak regulations, healthcare profes- independent of drug companies; interests. Some position statements and sionals and patients must remain vigilant. – public access to pharmacovigilance decisions taken by drug regulatory agen- databases, as in countries such as cies’ in 2011 are worthy of note: Do not confuse advertising and Canada, the United States, the Nether- – the French regulatory agency and EMA information. Healthcare professionals lands and the United Kingdom (Rev Pre- refused to authorise over-the-counter use and patients must keep in mind that drug scrire n° 337 - see this issue page 99); of sumatriptan in migraine (Prescrire Int companies’ advertising messages con- – requirement to compare new drugs n° 123); cerning their products should not be con- with a standard treatment before mar- – coherent changes were made to the sidered reliable sources of information. keting authorisation or reimbursement indications and dosages of penicillins M Efficacy is stressed while adverse effects status can be granted; (cloxacillin and oxacillin), useful older drugs, are downplayed or not mentioned at all: – measures to promote more convenient following reassessment by the French for example, varenicline in smoking cessa- treatment and safer packaging (see in a agency (Rev Prescrire n° 336). tion (Rev Prescrire n° 336 inside back cover), coming issue); However, other decisions represented the fixed-dose combination of tramadol + – Better initial and continuing education simple half-measures, such as the decision paracetamol for pain (Rev Prescrire n° 329 of healthcare professionals in drug ther- by the French agency to restrict the use of inside back cover and n° 337 inside back apy. antihistamine antitussives in children less cover), and ketoprofen gel for rheumatic ©Prescrire than 2 years old, even though these prod- pain (Rev Prescrire n° 328 inside back cover). ucts have a negative harm-benefit balance in older children and adults. It would have Pharmaceutical industry obsession been better to simply withdraw these prod- with drug promotion. Drug companies ucts from the market (Rev Prescrire n° 329). exploit every possible opportunity to promote their products, directly or indirectly, Drug regulatory agencies still pro- by various means, including: viding too little information on – patient management software (Rev Pres- adverse effects. Information provided crire n° 336); by regulatory agencies can help healthcare – healthcare professional “training” (Rev professionals manage their drug lists and Prescrire n° 331); choose the most appropriate drug for each – gifts to healthcare professionals. It has patient. In 2011, the French agency made been shown that even small gifts “of neg- an effort to improve the quality of this ligible value” elicit reciprocity on the part information. For example: of the recipient who is often unaware of – oleocalcic liniment: risk of burns when their influence (Prescrire Int n° 122); prepared at home by patients (Rev – drug companies have been known to Prescrire n° 328); send healthcare professionals falsi-

PRESCRIRE INTERNATIONAL APRIL 2012/VOLUME 21 N° 126 • PAGE 109 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only. Outlook A look back at new drugs and indications in 2011

Regulation of advertising: doubt- In the wake of the Mediator° scandal: ful effectiveness. Few unethical ads sanctioned in France. Few advertise- some progress in France, but apathy ments aimed at healthcare professionals at the European level were banned in France in 2011, according to the Official Journal (Journal Officiel). As in previous years, the violations were The aftermath of the Mediator° disaster pholcodine and varenicline (see inset mainly serious, including unethical broa- and the serious regulatory shortcomings page 108); dening of indications, promotion of off- it revealed led the French authorities to – in the public consultation launched by label use (including mequitazine during make some improvements to their proce- the European Medicines Agency (EMA), pregnancy), exaggeration of effectiveness dures and decisions in 2011 (Prescrire Int posted online in late 2010, the Agency (Rev Prescrire n° 333 and 340). Formal n° 121). For example: proposed to make head-to-head compar- notices to modify these ads are not made – The French drug regulatory agency isons with a standard drug the exception public in France. Healthcare professionals finally made a real effort to be more trans- in premarketing clinical trials, meaning were therefore unaware of having been parent: the working sessions of the mar- that placebo-controlled trials would exposed to misleading advertisements. keting authorisation committee are now become the rule (Prescrire Int n° 121); In Switzerland, despite more stringent described in detailed reports, albeit se veral – the European Commission left signal regulations requiring that all drug adver- months later; some (but not all) discus- detection and the interpretation of post- tisements should be evidence-based, the sions are now filmed and posted online; marketing surveillance data in the hands situation is appalling: half of the claims are and the agendas of the marketing autho- of drug companies. These are both key not backed up by the cited references, or risation committee are now made pub- elements of drug safety (isdbweb.org); are based on biased references (Prescrire Int lic. Previously, reports of this committee’s – the European Commission continues to n° 117). activities were scant, and none of its insist on removing barriers to direct-to-con- debates was filmed for public viewing; sumer advertising by drug companies for – the French agency triggered reassess- prescription-only drugs. Following the Support the new focus ment of several drugs at the European public outcry in late 2010, the Commission on patients’ interests level, including pholcodine, pioglitazone was forced to revise its proposals to allow (alone or combined with metformin), and direct-to-public advertising of prescription In France, the year 2011 was charac- trimetazidine; drugs, disguised as “information”. How- terised by the lack of major breakthroughs – the French agency decided to withdraw ever, the amended proposals published in in new drugs or new indications, but there several drugs with negative harm-benefit October 2011 still leave the door open to were some welcome decisions aimed at balances (see inset page 108); this type of advertising, particularly the improving patient safety in the wake of the – the French authorities are taking more proposed legalisation of reminder adver- Mediator° disaster, such as market with- notice of recommendations of the Trans- tising (a) (english.prescrire.org). drawal of drugs that had more harms than parency Committee (which assesses the The public must encourage authorities benefits. There was also a trend towards a medical benefits of new drugs and advis- to focus more on patient safety, through culture of transparency, and other changes es on drug reimbursement) to stop reim- actions such as those conducted by the in drug policy, the practical impact and sus- bursing several drugs rated as providing patient group Amalyste (victims of Lyell tainability of which remain to be seen. At inadequate medical benefit to patients, and Stevens-Johnson syndrome) and Act the European level, apathy prevailed and some of which have been on the market Up (people living with HIV/AIDS), and no new changes of significance were made for several years. member associations of the Medicines to protect patients’ interests. In contrast, the European authorities in Europe Forum (b) (“Prescrire Prize”, Drug companies must focus on produ- have yet to take action on these points: prescrire.org). cing high-quality pharmaceuticals (Pre- – the opacity of pharmacovigilance data ©Prescrire scrire Int n° 124) and ensuring an unin- persists: for example, information was terrupted supply of products with proven withheld on the risks of bladder cancer a- Reminder advertising is a marketing practice which clinical value, such as spiramycin oral sus- associated with pioglitazone (Prescrire aims to familiarise the public with a brand name by pension, which was no longer marketed in Int n° 123); using every opportunity to mention the name of the France in 2011, and sheep antidigitalin product, including using images of the brand and build- – doubts regarding drug safety still con- ing an emotional connection with the brand. antibodies, that are too often out of stock tinue to benefit drug company profitabili- b- Founded in March 2002, with more than 60 mem- and are replaced by various brand names ty rather than patients’ interests: some ber organisations in 12 European Union member states, and dosages (Rev Prescrire n° 333). drugs were kept on the market despite the Medicines in Europe Forum is composed of 4 major A more general overhaul is needed: groups of healthcare stakeholders: patient groups, fam- their established harms, including ily and consumer organisations, health insurers, and healthcare professionals must sever their dronedarone, nimesulide, pioglitazone, healthcare professionals (prescrire.org) links with drug companies (Rev Prescrire n° 330); patients must learn not to rely solely on medications (Prescrire Int n° 122); and all those concerned must choose reli- fied emails and letters from patients among other things, to promote ration- able sources of information. thanking their doctors for having pre- al use of healthcare and medicines, ©Prescrire scribed one of their drugs (Rev Prescrire most patient groups funded by phar- n° 330); maceutical companies support direct – “disease mongering”, particularly in the provision of “information” by drug com- field of psychiatry (Prescrire Int n° 112); panies (Prescrire Int n° 122); – funding of patient groups. According – harassment and vilification of scientists to a survey by Health Action Interna- by the Danish Association of the Phar- tional (HAI), an international network maceutical Industry (Rev Prescrire n° 328); of organisations and citizens striving, – etc.

PAGE 110 • PRESCRIRE INTERNATIONAL APRIL 2012/VOLUME 21 N° 126 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only.