Tag: healthcare politics

Categories : Obstetrics & Gynaecology PoliticsTags :

Miscarriage Should be Recognised as a Bereavement, Argues Psychiatrist

On By ModernMedia
Photo by Joice Kelly on Unsplash

A miscarriage during the first 6 months of pregnancy should be recognised as a bereavement, rather than illness in UK law, argues psychiatrist Nathan Hodson in correspondence published online in the journal BMJ Sexual & Reproductive Health.

Some MPs in the UK government have called for following in the steps of New Zealand’s policy of giving bereavement leave at  any stage of pregnancy loss, though this has been met with opposition.

The Parental Bereavement (Leave and Pay) Act 2020 allows for two weeks’ statutory bereavement leave for a stillbirth after 24 weeks and for the loss of a child up to the age of 18 in the UK. In South Africa, the 2002 Basic Conditions of Employment Act allows for six weeks’ maternity leave for pregnancy loss after 28 weeks.

Dr Hodson pointed out that parents in these circumstances are also entitled to take maternity or shared parental leave planned before the stillbirth, giving them weeks or months to recover from their loss.

But those who miscarry before 24 weeks in the UK have no such rights, added to which the miscarriage is regarded as an illness, with entitlement to sick leave. And if this lasts longer than 7 days, a formal sick note from a doctor is required.

“This policy creates an arbitrary cliff edge at 24 weeks,” with few women who miscarry being aware of their employment rights, Dr Hodson insisted.

Presently it is not known how many miscarriages occur in the UK annually nor how much sick leave is taken for them. He acknowledges this could open up private companies to unknown costs for employee miscarriage at any stage.

A single week of statutory bereavement leave when miscarriage occurs after the 12 week scan could reduce these costs. “Miscarriage risk after 12 weeks is less than 1% so this policy would be highly targeted with a less uncertain price tag,” he explained.

And within 2 or 3 years there should be sufficient data from New Zealand to estimate the impact of the policy, which was introduced in March this year. This allows women and partners 3 days of paid leave, irrespective of how long the woman had been pregnant, but excluding abortions.

But in any case, “miscarriage should as far as possible be recognised as bereavement, not sickness, and many parents will need time off work afterwards,” wrote Dr Hodson.

“Leave following first-trimester miscarriage should be prioritised when New Zealand has published data. But whatever approach is taken with regard to early miscarriages, the cliff edge at 24 weeks is a stark injustice demanding remedy.”

Source: EurekAlert!

Categories : PoliticsTags :

NHI Implementation on the Financial Rocks – For Now

On By ModernMedia
Photo by Michael Longmire on Unsplash

South Africa’s National Health Insurance (NHI) implementation continues to flounder, as the National Treasury notes its expenditure will not be a significant cost in the medium term. This scheme, which seeks to address the country’s huge gulf in healthcare inequality, has still made barely any progress since its inception over a decade ago.

In its Medium Term Budget Policy Statement published on Thursday (MTBPS), the Treasury said that the national health insurance policy was estimated to cost R40 billion per year in additional funding in the first five years, and perhaps considerably more over time. Therefore, it dismissed the possibility of any substantial work on it, saying that presently, “there is insufficient capacity in the health sector to work substantively on national health insurance. The national health insurance indirect grant has been underspent, the National Health Insurance Fund has not yet been established, and the National Health Insurance Bill still needs to be passed by Parliament.

“It is therefore unlikely that national health insurance will be a significant cost pressure in the medium term,” it said.

While the Department of Health has time and again reiterated its commitment to the NHI system, several studies highlight the system’s deep unpopularity among healthcare professionals. 

“To fund this, we need taxpayers,” said senior researcher Morné Malan at Solidarity Research Institute, when former Health Minister Dr Zweli Mkhize tabled the NHI Bill in Parliament in August 2019.

“To be a taxpayer you must be employed… only 12% of South Africans pay tax.”

In August 2021, trade union Solidarity published a report drawing on three surveys from 2018 to 2021, with 20.8% of respondents already preparing to leave.

Across the studies, the overarching response from healthcare professionals is one of uncertainty and mistrust around the NHI, with general sentiment towards the system being overwhelmingly negative.

“Almost all the respondents have serious concerns regarding the state’s ability to manage and administer the NHI,” Solidarity said. “The total administration and management of funds and decision-making will be in the hands of the state.

“Most are seriously concerned about the fact that the state can determine and enforce tariffs, place of work, type of diagnostic tests and type of medication and treatment.”

The opinions of those surveyed are likely shaped by the observed mismanagement and maladministration at state institutions such as Eskom, Solidarity noted. The NHI will be considerably larger and more complicated, and will have to manage and execute many contracts, it said.

Source: Businesstech

Categories : Ethics and LawTags :

Healthcare Organisations Urge Review of Culpable Homicide Law

On By ModernMedia
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Nine of South Africa’s leading healthcare organisations have joined together in urging the Government to begin a review of culpable homicide law and its application in a healthcare setting.

In a letter to the Minister of Justice and Correctional Services, Hon Ronald Lamola, the coalition said there is a very low threshold in South African law for blameworthiness when a patient dies while under medical care, which has resulted in errors of judgement in complex healthcare environments being criminalised, and healthcare professionals being convicted regardless of their intent.

The joint letter calls for the review to be carried out by the South Africa Law Reform Commission, due to the complexity of criminal law in a healthcare setting and the importance of achieving a long-term solution for healthcare professionals and patients alike.

The letter says: “It is hard to see who benefits from the current system. As well as families losing a loved one through tragic circumstances, doctors risk losing their career and liberty, and the fear of criminal charges also has a negative knock-on effect on patient care. The current system stands in the way of patients receiving an early apology and a full explanation of events, and thereby denies closure.

In a recent survey of 500 doctors, 88% are worried about investigations after an adverse patient outcome, and 90% think the prospect of criminal investigation affects their mental health. Due to the prospect of criminal investigation means nearly half of all doctors in South Africa have considered leaving the profession. The letter further notes that  4 in 5 doctors surveyed think the criminal justice system in South Africa has an inadequate understanding of medical practice.

Pointing out the need for a “long-term solution”, they write: “Healthcare professionals need to be held accountable, however, criminalising errors of judgement – particularly in this fast moving and complex healthcare environment – seems unreasonably severe. Criminalisation in the absence of any clear intention to cause harm is overly punitive, leaving healthcare professionals vulnerable to criminal charges. Lessons can be learned from other jurisdictions – for example, in Scotland, where charges are only brought against doctors if an act is proved to be intentional, reckless, or grossly careless.

“Our organisations are committed to the highest level of safety for all patients in South Africa. This will however require replacing the current culture of blame and fear with one of learning, where healthcare professionals feel able to apologise and learn from mistakes, which will help to reduce the number of errors and thus enable progress on improving patient safety. When healthcare professionals are allowed and supported to learn from mistakes, lessons are learnt, and patients are better protected in the future.

Highlighting the complexity of these matters, “Patients and clinicians want the same thing, for those in need to receive the best care,” the letter concludes.

The letter was signed by Medical Protection Society, Association of Surgeons of South Africa, Federation of South Africa Surgeons, Radiological Society of South Africa, South African Medical Association, South African Medico-Legal Association, South African Private Practitioners Forum, South African Society of Anaesthesiologists and South African Society of Obstetricians and Gynaecologists.

Source: Medical Protection Society

Categories : Ethics and Law Medical IndustryTags :

‘Extensive Network’ of Opaque Medical Industry Ties

On By ModernMedia
Image: Pixabay CC0

A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!

Categories : COVIDTags :

Stockpiling Could Cause 241 Million Vaccine Doses to be Wasted

On By ModernMedia
Image by Mika Baumeister on Unsplash

Analytics company Airfinity estimates the G7 and EU will have an excess of 1 billion vaccine doses by the end of 2021, of which 10% are expected to expire. 

When factoring the time taken to distribute and administer the doses in Lower Income Countries (LICs) and Lower Middle Income Countries (LMICs), the proportion rises. Many of these countries will refuse vaccines that don’t have at least a two month shelf life. Taking into account this two month shelf, 241 million doses could be wasted by the end of 2021, amounting to a quarter of the G7 and EU surplus stock. 

The available vaccines in the G7 and EU, together with already purchased doses and COVAX deliveries, are sufficient for LICs and LMICs to vaccinate 70% of their populations by May 2022. Airfinity estimates that total global COVID cases are likely to exceed 400 million by mid-2022 and immediately redistributing vaccines could potentially avert nearly 1 million deaths from the virus in that time frame. 

“Currently doses tend to get shared in low volumes, at short notice, and with shorter than ideal expiry dates – making it a huge logistical lift to allocate and deliver these to countries able to absorb them,” says Aurélia Nguyen, managing director of the COVAX facility.

Vaccine manufacturers are now making 1.5bn doses every month.

“They’re producing a huge number of doses. It has scaled up immensely over the last three or four months,” Dr Matt Linley, lead researcher at Airfinity, told BBC News.

“I don’t think it was necessarily rich countries being greedy, it’s more that they didn’t know which vaccines would work,” says Dr Linley. “So they had to purchase several of them.”

Airfinity hopes to show governments that there are enough vaccines to fulfil their needs, and thanks to this secure supply they can donate without stockpiling.

“They don’t want to be caught off guard,” said Agathe Demarais. “It’s also about domestic political pressure because part of the electorate would probably be very unhappy to see vaccines being donated, if there is a feeling that they’re still needed at home.”

Co-founder and CEO of Airfinity, Rasmus Bech Hansen said: “The world has witnessed two extraordinary scientific achievements in the pandemic: The fast development of highly effective vaccines and the unprecedented scale up of production.For the world to get the full benefit of this, our data shows, we need a third equally unprecedented achievement: A large scale, rapid, globally coordinated, science driven vaccination campaign.” 

Source: Airfinity

Categories : COVIDTags :

Govt Switches COVID Focus to Vaccine Access and Hesitancy

On By ModernMedia
Image by Quicknews

As the official COVID death toll in South Africa passes the 80 000 mark, the Department of Health is now shifting focus to addressing flagging vaccine demand.

The department said this will include making access easier, such as vaccinating at shops or places of work.

Another change would be providing transportation to vaccine sites to help those in underprivileged areas. One option being looked into is the introduction of home vaccinations and ‘pop-up’ sites in rural areas where travel is harder to come by and at busy commercial areas such as shopping centres.

The government also hopes for assistance from the religious sector, with the possibility of churches offering vaccines on a Sunday. Mosques, synagogues and other places of worship would also offer a ‘familiar environment’ where people feel comfortable receiving a vaccine.

Public awareness
Social media will be heavily employed for vaccine promotion, and could incude online influencers and ambassadors to encourage vaccination.
This could extend to identifying ‘apolitical’ vaccine champions relevant to the target group who have also great influence, such as celebrities and traditional leaders.

A number of awareness initiatives are being considered, including making use of channels such as social media and teachers to provide information to young people and counteract misinformation, as well as more traditional media efforts such as radio slots and signage.

Vaccine skepticism high in men
Department of Health Deputy director-general Dr Nicholas Crisp, pointed out that South Africa has a particular problem with men not wanting to be vaccinated.

“This is not good,” Dr Crisp said. “It means that men are going to end up very sick and in hospital, and we don’t want that to happen just before Christmas.”

An Africa Centres for Disease Control and Prevention (ACDC) study found that 66% of men in South Africa were sceptical about vaccine safety compared to 74% of women.

Mandatory vaccinations on the cards
Health minister Dr Joe Phaahla warned of a very long road ahead as new cases continue to spike.

The ministerial advisory committee on COVID is now discussing the possibility of mandatory vaccination for certain groups of people, which could include healthcare workers and those professions spending time indoors with other people, according to the Sunday Times.

Scientists and health activists told the paper that the right to refuse a vaccine is outweighed by the health hazard of the pandemic.

The country would then be able to reopen and operate in a way as close as possible to the pre-COVID era, said leading vaccinologist Professor Shabir Madhi.

“In these settings, if people choose not to be vaccinated, they should be compelled to undergo testing every three or four days at their own expense,” he said.

While vaccinations don’t confer complete COVID protection, it is still significant, and more impactful if a greater proportion are vaccinated, Prof Madhi said.

Source: BusinessTech

Categories : COVIDTags :

SA’s Department of Tourism Aims to Join Vaccine Passport System

On By ModernMedia
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The Department of Tourism says that it wants to introduce a vaccine passport for South Africa, but a number of international and legislative obstacles have to be overcome.

A lack of standardisation around vaccine passports worldwide is a key issue, said tourism director-general Nkhumeleni Victor Tharage in a briefing to Parliament on 17 August.

“Even in some jurisdictions that have opted to apply this (passport), there isn’t yet a sense of uniformity. When we don’t have a single, standardised specimen, it is a little bit difficult to say which one is which.

“If South Africa introduces (a passport), and there is access to information from the National Institute for Communicable Diseases (NICD) that confirms that a person has been vaccinated, the question is if that person arrives Lagos (Nigeria), what resources will they use to verify this information that is stored on a database in South Africa?”

South Africa has the same problem when it comes to verification of incoming tourists, Tharage said. The government was also cautious about introducing a vaccine passport system that is discriminatory against certain groups of people, he noted.

“When we reopen, and when everyone is starting to travel, it should not be discriminatory. And that principle has been reiterated time and time again.”

The vaccine passport could be a requirement for events, and Tharage said he was confident that this is something that the government could introduce with ease on short notice.

“At the end of the day, it’s about being able to get the necessary confidence from consumers, tourists and trade. If we don’t do that, then there will be a negative impact on our recovery.”

However, Department of Health spokesperson Foster Mohale affirmed that South Africa has no immediate plans to require proof of vaccination for any purpose.

Open for tourism
Transport minister Fikile Mbalula has said that his department is working with businesses to ensure that South Africa successfully reopens for international travel. Presenting his departmental budget speech at the end of May, Mbalula said that South Africa must ensure that it joins the increasing number of countries which accept the International Air Transport Association’s (IATA) mobile travel pass.

The travel pass is a mobile app that helps travellers store and manage their verified certifications for COVID tests or vaccines, and is more secure and efficient than current paper processes, IATA said. This is important given the potentially enormous scale of testing or vaccine verifications that the group must securely manage. IATA said it is looking to introduce further changes, such as QR code scanning by immigration officials.

Source: BusinessTech

Categories : COVIDTags :

WHO Urges Support for New COVID Origin Investigation

On By ModernMedia
Photo by Asad Photo Maldives from Pexels

The World Health Organization (WHO) has urged all countries “to put differences aside” in order to speed up investigations into the origins of the SARS-CoV-2 virus – including the unproven suggestion that it was accidentally released from laboratory.

This announcement follows a joint report into the origins of the coronavirus issued in March by the WHO and China. The UN agency, noting “insufficient scientific evidence to rule any of the hypotheses out” about the origins of the new coronavirus, insisted that to address the ‘lab hypothesis’, it needed access “to all data” in order to prevent global health threats in future.
“WHO calls for all governments to depoliticise the situation and cooperate to accelerate the origins studies, and importantly to work together to develop a common framework for future emerging pathogens of pandemic potential,” it said.

“We call on all governments to put differences aside and work together to provide all data and access required so that the next series of studies can be commenced as soon as possible.”

In a detailed statement, WHO explained the need for additional studies into “all hypotheses” about how SARS-CoV-2 made the jump from animals to humans.

Transparency call
A new independent advisory group of experts, the International Scientific Advisory Group for Origins of Novel Pathogens (SAGO), will support the project by coordinating the studies recommended in the March report, it said.

Nominations for the panel would be welcomed from all countries, WHO said, whose task would be similar to previous COVID missions to China and those launched to investigate the origins of avian influenza, Lassa virus and Ebola virus.

“This open call aims to ensure that a broad range of scientific skills and expertise are identified to advise WHO on the studies needed to identify the origins of any future emerging or re-emerging pathogen of pandemic potential,” the UN agency said.

Scientific endeavour
Noting how hard it is to identify the origin of any novel pathogen, the agency insisted that the mission “is not and should not be an exercise in attributing blame, finger-pointing or political point-scoring. It is vitally important to know how the COVID pandemic began, to set an example for establishing the origins of all future animal-human spill-over events.”

Access to sensitive information was needed for the success of the operation with “a further examination of the raw data from the earliest cases”, along with blood serum from potentially infected people in 2019, before the pandemic.

Data sharing
Data from “a number of countries” that reported finding the virus in blood samples taken in 2019 has already been shared with WHO, it noted. This included Italy, where WHO coordinated retesting of pre-pandemic blood samples outside the country.

“Sharing raw data and giving permission for the retesting of samples in labs outside of Italy reflects scientific solidarity at its best and is no different from what we encourage all countries, including China, to support so that we can advance the studies of the origins quickly and effectively,” WHO said, and restated that access to data was “critically important for evolving our understanding of science and should not be politicised in any way”.

Source: UN News

Categories : PoliticsTags :

A Look Back at Mkhize’s Tenure as Health Minister

On By ModernMedia
Image by Hush Naidoo from Unsplash
Image by Hush Naidoo from Unsplash

With Dr Joseph Phaahla being promoted from his position as Deputy Health Minister to replace the embattle, Dr Zweli Mkhize, Spotlight reviews Dr Mkhize’s tenure, writing that the very reason he was brought in to that post — to roll out National Health Insurance — would likely suffer a considerable setback as a result of his exit.

His appointment as South Africa’s Minister of Health in May 2019 came as a surprise for some. As one of the ANC’s top officials, the health portfolio seemed a meagre choice in the pre-COVID days.

However, Mkhize’s seniority signalled that health was being given high priority in the new administration. Theoretically, his greater political clout meant he would have a better chance of bringing much-needed reforms to provincial healthcare systems. Spotlight were also “cautiously hopeful that Mkhize’s firmer hand would help better organise and direct the National Health Department and the various national health entities.”

A string of procurement scandals during his time as KwaZulu-Natal’s Premier was cause for concern but was not direct evidence that he was corrupt.

The Digital Vibes scandal had the side effect of making Mkhize anathema to the very project he was originally brought in for, implementing National Health Insurance.

Even with Mkhize gone, the ANC will have a hard time convincing the public that we will not see more such looting once NHI is implemented. There has, after all, been little willingness from ANC members in Parliament to engage seriously with people’s concerns about the proposed NHI structure and governance arrangements set out in the NHI Bill.

Mkhize tackled COVID from a scientific standpoint, which is fortunate for the nation considering the anti-scientific stance of the former Minister of Health Dr Manto Tshabalala-Msimang. However, the decision not to use AstraZeneca vaccines remains contentious. Meanwhile, a purge of scientists, starting with Professor Glenda Gray, let Mkhize surround himself with allies, according to Spotlight.

However, entering the third wave with vaccinations lagging so far behind was a governance disaster possibly even worse than the Digital Vibes scandal.

From an outside perspective, the past two years have not seen great progress in the department, despite some competent individuals, with infighting, under-capacity and most seriously, poor management. The procurement department

Source: Spotlight

Categories : Medical IndustryTags :

Over 100 Fast-tracked Drugs Not Confirmed Effective

On By ModernMedia

Of 253 drugs approved via the FDA’s accelerated approval pathway, clinical effectiveness has been confirmed in 112, according to a new investigation by The BMJ.

Clinical reporter Elisabeth Mahase found that, as of the end of last year, 24 of those 112 drugs have been on the market for more than 5 years, and some have been on the market for more than 2 decades — often with a high price tag, according to.

Though the accelerated approval pathway allows drugs onto the market before efficacy has been established, the manufacturer has to perform confirmatory trials or else the approval will be rescinded.

However, Mahase noted that only 16 drugs authorised through the accelerated approval pathway have been withdrawn since its creation in 1992 . Most of those were shown to lack efficacy, but in some cases, confirmatory trials were simply never done. Celecoxib (Celebrex), for example, was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, a genetic disorder that carries a high risk of bowel cancer if untreated, remained on the market for about 12 years before the FDA asked Pfizer to voluntarily withdraw it for this specific indication because efficacy trials were never completed.

The BMJ asked the manufacturers of 24 drugs that have been on the market for more than 5 years if they had conducted phase IV trials. Six drugs had been withdrawn, approved, or postponed. Of the remaining 18 drugs, relevant trial information was provided for a third. Four manufacturers of those six drugs were recruiting participants, and two reported talking to the FDA about final trial design. Eleven companies representing 12 drugs did not respond.

FDA response

“We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” an FDA spokesperson said in a statement provided to MedPage Today. “The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies.”

The FDA could choose to initiate proceedings to withdraw a drug’s approval should post-marketing trials show no benefit or not be performed in time, added the spokesperson.

“Because the FDA continues to use this pathway to accelerate access to drugs for serious and life-threatening diseases for which there is an unmet medical need, at any point in time there will be drugs that are not converted because the confirmatory trials are ongoing,” the spokesperson said.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited, to the detriment of patients — who may be given a drug that offers little benefit and possible harm — and of taxpayers,” she continued.

Fixing the accelerated approval pathway

Concerns about the accelerated approval pathway include a lack of threats from the FDA to withdraw a drug should confirmatory trials not be done, the agency’s use of indirect (or surrogate) measures of clinical benefit in some cases, and the potential for drug manufacturers to take advantage of the pathway when it comes to actual measures of safety and effectiveness, Mahase wrote.

Nevertheless, experts still agree that the accelerated approval pathway is of benefit, she noted. Suggested changes to the pathway include planning or starting confirmatory trials as part of the approval as well as closer examination of surrogate measures.

A recent example is Biogen’s controversial Alzheimer’s disease treatment aducanumab (Aduhelm) received FDA approval via the process last month, which was based on the surrogate endpoint of reduction of amyloid-beta plaque in the brain.

The drug has attracted criticism since its recent fast-track approval, with critics pointing out that the drug has not been proven effective and its $56 000 annual price is unreasonable.

Source: MedPage Today

Journal information: Mahase E “FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway” BMJ 2021; DOI: 10.1136/bmj.n1898.