Archives : 2023

Patient characteristics

Editorial The best treatment option in a given clinical situation is the one that offers the best balance between efficacy and harm, making it the most suitable option for most patients. For most patients, but not all. Because sometimes a patient characteristic shifts this balance to a point where another treatment would be more suitable.
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1 December 2023

Nirsevimab (Beyfortus°) to prevent RSV infection in infants

Marketing Authorisations Palivizumab was the first drug to receive European marketing authorisation for the prevention of RSV infection. Its use is restricted to certain infants at increased risk of developing severe disease. Nirsevimab, another monoclonal antibody directed against the RSV F protein, has been authorised for the prevention of RSV infection in neonates and infants, including those who have no risk factors for developing severe disease. Does nirsevimab reduce the incidence of severe RSV disease or death compared with palivizumab in infants with risk factors, or compared with placebo in healthy full-term infants?
Full article (3 pages) available for download by subscribers

1 December 2023

Negative post-marketing trials: often ignored

Outlook Accelerated or conditional marketing authorisation pathways are designed to speed up patient access to potential therapeutic advances. But when post-marketing trials conducted to evaluate these drugs using clinical endpoints do not confirm the pre-authorisation trial results obtained using surrogate endpoints, drug regulatory agencies and the organisations responsible for cancer guidelines rarely take these negative results into account.
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1 December 2023

Ustekinumab (Stelara°): no live vaccines before 6 months of age for infants who have been exposed in utero

Adverse Effects Infants exposed in utero to an immunosuppressant such as ustekinumab are, as a result, susceptible to serious infections for several months after birth if they are given a vaccine containing live attenuated bacteria or viruses.
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1 December 2023

Zonisamide: as dangerous as topiramate during pregnancy?

Adverse Effects The EMA has concluded that a pregnancy test should be "considered" before initiating treatment with zonisamide. Its close pharmacological similarity to topiramate, which has established teratogenic effects, plus the few available data, indicate the need for caution in women who are, or could become, pregnant.
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1 December 2023

France's health technology assessment body: pushed to lower the bar!

Outlook The HAS's new principles for rating drugs, designed to facilitate access to new treatments, allow lower-quality evaluation. This may not be in patients' best interests.
Full article available for download (free)

1 December 2023

Drugs to avoid: an analysis of Australia’s pharmaceuticals market

Outlook A study by Australian academics, based on Prescrire’s annual review of drugs to avoid.
Full article available for download (free)

1 December 2023

Proposed multi-stakeholder platform to improve clinical trials in the European Union

Advancing Healthcare Policy Prescrire has responded to the consultation on the proposed key priorities for the platform, but chose not to apply for membership, in order to safeguard its independence.
Full article available for download (free)

1 December 2023

Flexibility

Editorial Healthcare professionals often specify how and when medicines should be taken when prescribing, dispensing or administering them, whether or not this information is included in the patient leaflet. These instructions are usually based on information provided in the summary of product characteristics, but is the level of evidence sufficiently strong to serve as a basis for hard and fast rules?
Full article available for download (free)

1 November 2023

Tebentafusp (Kimmtrak°) in metastatic uveal melanoma

Marketing Authorisations Tebentafusp, a fusion protein consisting of a T cell receptor fused to an anti-CD3 antibody fragment, has been authorised in the European Union for the treatment of metastatic or inoperable uveal melanoma, in HLA-A*02:01-positive patients. About half of the population of western Europe are HLA-A*02:01-positive. Does tebentafusp extend survival in this situation? And what are its adverse effects?
Full article (2 pages) available for download by subscribers

1 November 2023

Biotin: misleading thyroid function test results

Adverse Effects Biotin, present in dietary supplements in particular, can lead to false results with serum-based thyroid function tests.
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1 November 2023

Evaluation of new drugs and medical devices in Europe: a highly critical report from the KCE

Outlook In late 2021, the Belgian Health Care Knowledge Centre (KCE) published a detailed and highly critical report assessing the conditions under which new drugs and medical devices enter the European market. The report includes a list of recommendations for ensuring that the different stakeholders involved (patients, healthcare professionals, health technology assessment agencies, reimbursement approval bodies and payers) have access to the necessary comparative evaluations before new health products enter the market.
Full article (2 pages) available for download by subscribers

1 November 2023

When should levodopa be taken: with meals or between meals?

Queries and Comments Different sources (summaries of product characteristics, prescribing information) give very different recommendations on how to take levodopa, the first-choice drug for reducing the motor disorders of Parkinson’s disease. Prescrire's answer to a volunteer from a French patient group points out the absence of robust clinical evaluation data and proposes a pragmatic approach.
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1 November 2023

Diclofenac: also harmful for the environment

Outlook Diclofenac, a drug with widespread presence in the environment, has well-demonstrated environmental toxicity. Another reason not to choose diclofenac.
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1 November 2023

Remdesivir (Veklury°) in covid-19 at increased risk of progression to severe disease, or in children on oxygen

Covid-19 In a double-blind randomised placebo-controlled trial in 562 unvaccinated patients with covid-19 (before the emergence of the Omicron variant of Sars-CoV-2) who did not require supplemental oxygen, a 3-day course of remdesivir reduced the proportion of patients hospitalised for acute care over the 28-day follow-up period. It is unclear whether these results can be transposed to the epidemiological context of 2023 in which a high proportion of the population has been immunised through vaccination or prior infection with Sars-CoV-2, and Omicron is by far the most dominant variant.
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1 November 2023

No regard for patients!

Editorial Risperidone for monthly injection (Okedi°) was granted marketing authorisation on the basis of a randomised placebo-controlled trial in patients experiencing an acute exacerbation of schizophrenia (see “Risperidone as monthly injections” Prescrire Int n° 252 > Subscribers only). This placebo-controlled trial was doubly disgraceful.

1 October 2023

Rimegepant (Vydura°) in migraine

Marketing Authorisations Rimegepant is another CGRP receptor antagonist, with a chemical structure completely different from that of the monoclonal antibodies initially available. It is the first CGRP inhibitor to be authorised in the European Union for oral administration, both for the treatment and prevention of migraine attacks.
Full article (4 pages) available for download by subscribers

1 October 2023

Lenacapavir (Sunlenca°) in multidrug-resistant HIV-1 infection

Marketing Authorisations Lenacapavir is an antiretroviral drug that binds to the HIV-1 capsid. This disrupts various steps in the HIV lifecycle in which the capsid plays a role, such as transport of the viral genome into the nucleus of an infected cell, integration of the viral genome, and assembly of various viral components. It is the first antiretroviral with this mechanism of action to have been authorised in the European Union.
Full article (3 pages) available for download by subscribers

1 October 2023

Cannabidiol: sometimes serious adverse effects, and multiple drug interactions

Adverse Effects Cannabidiol (CBD), a cannabinoid, is naturally present in cannabis. Cannabidiol is used as an antiepileptic. Some CBD-containing products are sold without the regulatory status of medicines, and sometimes also contain other cannabinoids.
Full article (1 page) available for download by subscribers

1 October 2023

Drug shortages: patients lose out, healthcare professionals waste time

Outlook Drug shortages expose patients to a risk of serious, sometimes fatal, adverse effects, medication errors, and worsening of their disease. In daily practice, the workload of healthcare professionals is increased, with harmful consequences for the healthcare system, exacerbating an already fragile situation. In 2020-21, using the French pharmacovigilance database, France’s regional pharmacovigilance centres (CRPV) carried out a study on the consequences of drug shortages.
Full article (2 pages) available for download by subscribers

1 October 2023

Prescrire: a cosignatory of letters to various European institutions

Advancing Healthcare Policy In late 2022, Prescrire was a cosignatory of letters to three institutions in Europe: the Council of the European Union, the European Patent Office, and the European Parliament's Special Committee tasked with evaluating the handling of the covid-19 pandemic.

1 October 2023

Publication of clinical trial protocols

Advancing Healthcare Policy In a joint letter to the European Medicines Agency's Management Board, Prescrire contested an Agency plan that would delay publication of the protocols of drug trials.

1 October 2023

Practicalities

Editorial A drug is more than just an active substance mixed with excipients. There is more to consider than its pharmacological properties or its economic success. A drug is also a physical product that is part of the patient's daily life. And its packaging components, such as its box, the blister packs, bottle, vial or syringe, and the patient leaflet, are an integral part of this.

1 September 2023

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Marketing Authorisations Nivolumab, a monoclonal antibody directed against PD-1, has been authorised for patients with metastatic or inoperable gastric or oesophageal adenocarcinoma or squamous cell carcinoma. In these situations, does nivolumab represent a therapeutic advance compared to the treatments already available, and, in particular, does it extend survival?
Full article (3 pages) available for download by subscribers

1 September 2023

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Adverse Effects In 2022, a French research team published a case-control study which investigated the association between exposure to a GLP-1 receptor agonist and the risk of developing thyroid cancer.
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1 September 2023

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Marketing Authorisations Glucarpidase has been granted marketing authorisation in the European Union for reducing plasma concentrations of methotrexate in patients who have received high-dose methotrexate for cancer treatment when elimination is delayed due to impaired renal function. In this situation, does glucarpidase reduce an excessively high plasma concentration of methotrexate? Does it limit the serious dose-dependent adverse effects of this cytotoxic drug? And what are its adverse effects?
Full article (2 pages) available for download by subscribers

1 September 2023

Prescrire's annual review of drug packaging: progress is too slow

A drug's packaging contains a set of components for use by patients, their caregivers and healthcare professionals. It is important that packaging is well designed with a view to ease of use and the prevention of errors with dangerous consequences.
Full article (4 page) available for download (free)

1 September 2023

R&D costs: secrecy at every level

In France, the pharmaceutical industry has managed to turn a law to ensure transparency about the public funding it receives into a promotional opportunity.
Full article available for download (free)

1 September 2023

Conditional marketing authorisation: easier to grant than to revoke

Progesterone is ineffective at preventing preterm delivery, but proved difficult to withdraw from the market. It is not the only example of this phenomenon.
Full article available for download (free)

1 September 2023

Interdisciplinary collaboration

Editorial Many healthcare professionals routinely provide care for a specific patient by working together or as part of a multidisciplinary team. When well organised, such collaborations are synergistic, and beneficial for patients.

1 July 2023

Spotlight: Archives

Spotlight

2023

Patient characteristics

Nirsevimab (Beyfortus°) to prevent RSV infection in infants

Negative post-marketing trials: often ignored

Ustekinumab (Stelara°): no live vaccines before 6 months of age for infants who have been exposed in utero

Zonisamide: as dangerous as topiramate during pregnancy?

France's health technology assessment body: pushed to lower the bar!

Drugs to avoid: an analysis of Australia’s pharmaceuticals market

Proposed multi-stakeholder platform to improve clinical trials in the European Union

Flexibility

Tebentafusp (Kimmtrak°) in metastatic uveal melanoma

Biotin: misleading thyroid function test results

Evaluation of new drugs and medical devices in Europe: a highly critical report from the KCE

When should levodopa be taken: with meals or between meals?

Diclofenac: also harmful for the environment

Remdesivir (Veklury°) in covid-19 at increased risk of progression to severe disease, or in children on oxygen

No regard for patients!

Rimegepant (Vydura°) in migraine

Lenacapavir (Sunlenca°) in multidrug-resistant HIV-1 infection

Cannabidiol: sometimes serious adverse effects, and multiple drug interactions

Drug shortages: patients lose out, healthcare professionals waste time

Prescrire: a cosignatory of letters to various European institutions

Publication of clinical trial protocols

Practicalities

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Prescrire's annual review of drug packaging: progress is too slow

R&D costs: secrecy at every level

Conditional marketing authorisation: easier to grant than to revoke

Interdisciplinary collaboration