Report highlights missed lung cancer diagnosis despite multiple GP visits

The latest report published by the Healthcare Safety Investigation Branch (HSIB) explores the impact of the missed detection of lung cancer on chest X-rays of patients being seen in primary care.

The national investigation was triggered by a reference case focusing on a 50-year-old woman, who visited her GP multiple times over the course of a year with respiratory symptoms. The three chest X-rays she had during this time did not identify her lung cancer and the lady was finally diagnosed with a CT scan. She is still undergoing cancer treatment.

The report highlights that the delayed diagnosis of lung cancer has a wide geographic spread and is well recognised as a national safety risk. Research cited in the report highlights that estimated five-year survival rates in the UK are among the lowest in Europe. This reflects the fact that two-thirds of patients are diagnosed at an advanced stage.

Following analysis of the reference case, the HSIB examined the national context and considered the factors that contribute to this delay when patients repeatedly attend primary care with non-specific symptoms.

The national investigation identified that lung cancer in people who don’t have the usual risk factors, in particular, smoking, is increasing. However, the close link between smoking and lung cancer together with the often non-specific symptoms of the disease creates a significant diagnostic challenge for GPs. In the reference case, for example, the patient was considered low risk because she had never smoked.

Key findings also focused on the use of chest X-rays as they are the recommended first test to assess for lung cancer. However, the report emphasises that X-rays can be difficult to interpret, and notes evidence that shows one in five cancers are missed. Even if the patient has ongoing symptoms, a chest X-ray that does not identify a lung cancer has the potential to falsely reassure GPs.

The report concludes with three recommendations. These focus on commissioning research to evaluate how clinical and cost-effective low-dose CT scans are compared to chest X-rays to assess for lung cancer in symptomatic patients seen in primary care.

It also recommends reviewing and improving safety netting advice for health professionals and creating guidance to support independent benchmarking of artificial intelligence (AI) designed for the identification of lung diseases such as cancer.

Kathryn Whitehill, Principal National Investigator at HSIB says:

“Delayed diagnosis of lung cancer is a well-known safety issue across England and it was prioritised by HSIB as a theme for national investigation. Even though there has been advances in diagnostic technology, we wanted to understand why the risk remained of missing lung cancer on chest X-rays and explore the complexities associated with making improvements to the diagnostic process.

“While smoking is still the key risk factor for lung cancer, our report emphasised that it is increasing in those that have never smoked. The continued focus on the smoking link, across the media and public messaging, can exacerbate the existing diagnostic challenge for GPs and heighten the risk that a lung cancer is missed. The investigation’s findings, safety recommendations and safety observation aim to facilitate the timely diagnosis of lung cancer and so improve care for patients across the NHS.”

You can read the full report here.

Advertising regulator sanctions CBD oil company

The Advertising Standards Agency (ASA) has upheld a number of complaints about a company advertising CBD oil after the adverts were found to have made ‘misleading’ claims about the health benefits of CBD oil.

A 48-minute teleshopping presentation for ProLife CBD Oils, seen on the Gemporia television channel on 22nd May 2021, featured a presenter from Gemporia and one of the co-founders from ProLife CBD. Throughout the advert they made a number of claims about the health benefits of the products and referenced that the products were registered with the Food Standards Agency (FSA).

Two complainants challenged whether the claims that:

1. ProLife CBD Oil was effective for treating or helping with the conditions and illnesses referenced in the advert stated or implied that a food prevented, treated or cured human disease; and

2. CBD oil “helps with: General well-being” and “helps your immune system” were health claims that complied with the Code.

3. The ASA challenged whether the presentation misleadingly implied that ProLife CBD Oils were approved by the Food Standards Agency.

Gemporia Ltd said they were not able to substantiate the first two claims or demonstrate that they were authorised claims in the Great Britain nutrition and health claims (NHC) Register (the NHC Register).

Gemporia Ltd said they had understood that because a Novel Foods application had been submitted to the FSA, the products were allowed to be marketed and any references made in relation to this were based on that assumption, but that they had misunderstood the context.

They acknowledged that they had breached the Code on all issues and said their future advertising would adhere to the Code.

The ASA considered that consumers would understand from the presentation that ProLife CBD oils could treat or help with all the conditions that were mentioned, including those that appeared on the two presentation slides, in the testimonials and those mentioned by the presenters. We concluded the claims implied the product, a food, prevented, treated or cured human disease, which was prohibited under the Code.

On that point, the ad breached BCAP Code rules 13.6 and 13.6.2 (Food, food supplements and associated health or nutrition claims).

A representative of the ASA commented:

“Only health claims authorised on the NHC Register could be made in ads promoting foods or food supplements. Marketers must also ensure that the advertised food or food supplement met the conditions of use associated with the authorised health claim. Health claims were defined as those that stated, suggested or implied a relationship between a food or ingredient, and health.

“We considered viewers would understand the claim “helps your immune system” to mean that the CBD in the product would help with the effective functioning of the immune system. The claim was therefore a specific health claim about the benefits of CBD, for the purposes of the Code, which must be authorised on the NHC Register. However, there were no health claims relating to CBD authorised on the NHC Register and the claim therefore breached the Code.

“We considered the claim “Helps with: General well-being” to be a reference to the general benefits of CBD for health-related wellbeing. It was therefore a general health claim that needed to be accompanied by a specific authorised health claim relating to CBD. However, because there were no authorised health claims for CBD, that claim also breached the Code.

“On that point, the ad breached BCAP Code rules 13.4  13.4.2  13.4.3 (Food, food supplements and associated health or nutrition claims) and 13.7.1 (Vitamins, minerals and other food supplements).

“The BCAP Code required that ads must not claim that the advertised product had been approved, endorsed or authorised by any person or body if it had not or without complying with the terms of the approval, endorsement or authorisation.

“We considered consumers would understand the references made in the ad about the Novel Foods Act and ProLife CBD Oils being FSA “registered” to mean that ProLife CBD Oils had gone through the full FSA approval process required for CBD products and were authorised novel foods. We also considered consumers would understand the claims made in the ad that CBD products must be of a certain standard and quality in order to be FSA “registered” to mean that novel food authorisation was granted based on those criteria only. We further considered that consumers would understand the claims that ProLife CBD Oils were the “best standard” and “had always had the quality” to mean they had been authorised as novel foods based on this criteria alone. We considered that the ad implied that the products were approved, endorsed or authorised by the FSA.We acknowledged that novel food applications had been submitted to the FSA for the advertised ProLife CBD Oils and that the products were therefore allowed to be on the market. However, we understood that their applications were still under review and therefore the products were not yet authorised novel foods. We also understood that a dossier of information needed to be submitted when applying for novel food authorisation, and that the certificate of analysis and stability reporting testing was only one part of that. The primary objective of the novel food authorisation process was to establish that foods that had not previously been commonly used for human consumption were safe for that purpose, rather than to assess the ‘quality’ of the product as consumers would interpret that claim in the ad.

“Because the products were still under review by the FSA and the novel foods application process considered factors other than the quality of the product, we concluded the ad misrepresented the requirements for novel foods authorisation and misleadingly implied the ProLife CBD Oil products were approved, endorsed or authorised by the FSA.

“On that point, the ad breached BCAP Code rules 3.1 (Misleading advertising) and 3.47 (Endorsements and testimonials).

“We told Gemporia Ltd to ensure that any general health claims made in their future presentations were accompanied by a specific authorised health claim, and that specific health claims were authorised on the NHC Register. We told them to ensure that their future presentations did not state or imply that their food supplements could prevent, treat or cure human disease. We also told them not to state or imply that ProLife CBD Oils were endorsed, approved or authorised by the FSA and to not misrepresent the requirements for a novel food authorisation.”

You can read more here.

Clinical trialists to be offered ‘top-up’ vaccine doses

Vaccine clinical trial participants are to be offered the option to get additional vaccine doses from next week, to ensure they can travel abroad to countries that currently only accept vaccination records with approved for deployment COVID-19 vaccinations.

The UK recognises those who are in COVID-19 vaccine clinical trials as fully vaccinated for the purpose of certification, both domestic and international. The majority of other countries currently do not recognise clinical trial volunteers and require visitors to have been fully vaccinated with a vaccine that has been approved for deployment by the relevant medicines regulator.

The government has therefore taken the decision that those who are in COVID-19 vaccine clinical trials who have not had a vaccine that is approved for deployment will be given the opportunity to receive two additional doses of an approved vaccine. This will allow them to have the necessary certification status to travel abroad to countries which do not currently recognise trial vaccinations.

The additional doses will initially be offered to those taking part in the Novavax trial, which includes the vast majority of those in ongoing trials for vaccines not yet approved for deployment. The offer will then be rolled out to participants in other relevant trials within the coming weeks. Novavax participants will be offered two doses of the Pfizer/BioNTech vaccine, with an eight-week interval between first and second doses.

In addition, people who have received both doses of a vaccine as part of a clinical trial will also be offered a booster jab, if eligible in line with the wider boosters advice from the Joint Committee on Vaccination and Immunisation (JCVI). This is to ensure the protection they’ve received from vaccination as part of the trial is prolonged over the winter months.

This new approach, which will apply to England, has been developed with the independent experts on the JCVI and the chief investigators for the clinical trials.

Deputy Chief Medical Officer Professor Jonathan Van-Tam said:

“COVID-19 vaccine trials have been absolutely integral to our response to the virus, and as a result we now have our renowned vaccination programme, which continues to save lives. I urge as many people as possible to continue contributing to these trials.

“The measures we have taken will allow UK COVID-19 vaccine trial participants to travel freely overseas once they have had the additional vaccinations. Those volunteers now have the flexibility to make a decision for themselves so they can, for example, visit loved ones abroad.

“We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary.

“As a separate issue, those in trials who are eligible for boosters should receive the booster dose in order to ensure the highest possible protection over winter.”

Principle Investigator of the Novavax clinical trial Professor Paul Heath said:

“I very much welcome this development on behalf of the more than 15,000 participants in the Novavax trial and my colleagues in the 35 UK trial sites.

“For too long the participants have been disadvantaged in terms of international travel because this vaccine is not yet approved for deployment – but trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish to.”

RPS backs climate action charter

The Royal Pharmaceutical Society (RPS) has announced that they are a signatory of the Professional Bodies Climate Action Charter that is being launched today.

Developed by the Professional Associations Research Network of which the society is a long-standing member, the charter is designed to guide effective and high-quality climate action by professional bodies under the banner of three broad commitments:

  1. Firstly, to chart a path that supports professionals to deliver their practice in line with the Paris Agreement and UN sustainability goals.
  2. Secondly, to commit signatories to speak with a united voice in support for climate action when addressing other professional bodies, national governments and the public.
  3. Thirdly, to empower and inspire individual members to drive sustainability by developing resources that help enable the adoption of environmental best practices.

Commenting, RPS President Clare Anderson said:

“The Professional Bodies Climate Action Charter was discussed at our recent 3 country board meeting. I’m pleased that there was unanimous agreement that it was absolutely right for us to be signatories and to adopt the charter’s principles into our activity on climate change.

“This charter will act as a catalyst to bring people together and for best practice to be shared across professional groups. With climate change being such a seismic challenge, collaboration of this kind is vital.”

RPS Chief Executive Paul Bennett added:

“At RPS, our work on climate change is continuing to move forward. Following our declaration of a climate emergency in September, we are now working on a policy that will outline pharmacy’s role in sustainable healthcare. We’ll also continue to highlight the innovative work of our members and are developing a space for networking and sharing best practice on sustainability for RPS members as part of the new RPS Connect platform.”

What has a funeral director got to do with vaccinations?

David Wightman was one of the youngest ever funeral directors in the UK. He has over 28 years of experience in his sector.

We were very lucky to have some of his time to discuss his insight into death and dealing with families at the end of life. We had a good chat about the topic of death and how pharmacists might make an input when people are going through bereavement.

About David

David’s new business, Prokey, is a new vaccination and management solution that aims to address this unmet need through a partnership with Pharmadoctor, the UK’s leading provider of vaccination service packages to UK pharmacies.

Tapping into Pharmadoctor’s network of over 8,000 partner community pharmacies, Prokey provides funeral directors, private care sector works, lifeboat crews, first aiders and emergency service workers with a one-stop-shop vaccination service, ensuring businesses and organisations can find out which vaccines their teams require and arrange access for them. Pharmacies will be able to opt in to participate in the Pharmadoctor-Prokey Partnership and receive client referrals.

Pharmadoctor will support Prokey clients to register online for a service such as hepatitis B vaccination, then, via the Prokey website, book an appointment at their local Pharmadoctor partner pharmacy to receive their jab(s). 

Prokey founder and CEO David Wightman is a serving funeral director and embalmer with nearly 30 years experience, a seasoned health and safety officer and an active lifeboat volunteer based in the beautiful seaside town of Broughty Ferry on the east coast of Scotland. Commenting on why he created Prokey, David says:

“Having struggled to manage and source the appropriate vaccinations for my team of funeral directors in my role as health and safety officer, I wanted to create a simple solution which can be used by other professional and volunteer organisations across the UK so that they can protect their teams with the minimum hassle and disruption”. He goes on to say “When you’re out there helping others, your own safety can be the last thing on your mind. I genuinely want to see everyone around me carry out their duties as safely as possible, so if you are in the business of helping others, Prokey’s in the business of helping you”.

David told us that Prokey has already teamed up with pharmacy group Davidsons Chemist so that their 44 branches throughout Scotland will provide the Prokey service. Commenting on the partnership with Prokey, Davidsons Chemists Superintendent Pharmacist Karen Gordon said:

“Our collaboration with Prokey will provide the communities our pharmacies serve with cost-effective private vaccination services in addition to the clinical services our branches already provide”. Mrs Gordon goes on to say “we hope our collaboration with Prokey also helps to highlight the wider value community pharmacies play in providing the public with access to convenient local healthcare services”.

You can find out more about Prokey on their website.

Malaria vaccine recommended by WHO

The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019.

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

Based on the advice of two WHO global advisory bodies, one for immunization and the other for malaria, the Organization recommends that:

“WHO recommends that in the context of comprehensive malaria control the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.  RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.”

Next steps for the WHO-recommended malaria vaccine will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.

World Health Organisation (WHO) Director-General Dr Tedros Adhanom Ghebreyesus commented:

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control, using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

Dr Matshidiso Moeti, WHO Regional Director for Africa commented:

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering, we have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”

You can read more on the WHO website.