‘Unresolvable conflict’: are links to big tobacco changing inhaler prescribing?

When Marlboro cigarette maker Philip Morris International (PMI) took over UK-based asthma inhaler company Vectura in September 2021, there was immediate backlash.

The £1.1bn takeover was part of the tobacco giant’s long-term plan to develop smoke-free products and make the move to being a “broader healthcare and wellness company”.

But respiratory experts and health organisations were quick to register strong objections to the move, including asking the government to intervene before the deal was signed off.

The British Thoracic Society (BTS) was among those calling for the takeover to be stopped, given the “inappropriateness” and “unresolvable ethical conflict” that would be generated by the deal​[1]​.

The Royal Pharmaceutical Society (RPS) also wrote a letter to the government, asking it to oppose the deal, noting that tobacco companies should not profit from the illnesses their products cause.

After the buyout was approved, Vectura was removed from a UK pharmaceutical conference in response to a protest from academics and there were reports that doctors and patients would shift to rival products, with sales of Vectura-associated inhalers slowing down as a result​[2,3]​.

Despite the ongoing negative publicity, an exclusive analysis by The Pharmaceutical Journal shows that, since PMI took over, there has been little difference in overall prescribing of inhalers either manufactured by Vectura or with licensing links to the company (see Figure 1).

The analysis of data published by Open Prescribing shows that overall monthly prescribing for inhalers with ties to Vectura has increased by 3% from 378,573 items in September 2021, when the UK-based device company was taken over by the tobacco giant, to 388,194 in March 2024.

And while Vectura accounts for 2022 show a 32% drop in revenue, a company report attributed this mainly to a patent expiring and associated royalties coming to an end​[4]​.

Little change

In October 2023, the charity Asthma + Lung UK, supported by the BTS, RPS, Primary Care Respiratory Society and others, published an information leaflet for patients that explained the link between PMI and some asthma inhalers​[5]​.

In a statement, Sarah MacFadyen, head of policy and external affairs at Asthma + Lung UK, told The Pharmaceutical Journal: “PMI is one of the world’s largest tobacco companies. Addictive tobacco products cause and exacerbate lung disease, so their takeover of Vectura has been widely condemned.  

“If people feel uncomfortable using an inhaler brand linked to the tobacco industry, they should speak to their healthcare professional about trying an alternative device. For most people there are a range of alternatives, which are just as effective and safe.”  

However, she noted that the priority will always be to ensure people have the best treatment they need to manage their lung condition well, and for healthcare professionals to make sure their patients have the medicines that are safe and work for them.   

These competing factors facing prescribers have meant the dramatic drop-off in prescribing that some were hoping for has not materialised.

Data collated through Open Prescribing show that, since September 2021 (when the takeover was agreed), the NHS in England has spent £433.9m on Vectura-associated inhalers.

Monthly spend on the inhalers has risen from £13.4m in September 2021 to £14.5m in March 2024 — the latest available data — and there has been no change since Asthma + Lung UK publicised the link between Vectura and PMI to patients in October 2023.

The data also show that, since the takeover, just under 12 million Vectura-related inhaler items have been prescribed in England.

And while there are downward trends in the prescribing of some individual inhalers (see Figure 2), this is more likely owing to clinical or even climate-related choices, prescribing experts tell The Pharmaceutical Journal.

The figures raise questions over whether the NHS should be doing more to flag the link to those making prescribing decisions.

Not straightforward

Nicholas Hopkinson, professor of respiratory medicine at the National Heart and Lung Institute, Imperial College London, has been one of the most outspoken critics of the takeover. He believes the NHS needs to make it easy for people to do the right thing.

“The attempt by the tobacco industry to launder its reputation by moving into inhaled medication is disgraceful,” he tells The Pharmaceutical Journal.

“Philip Morris kills at least a million people every year, and people with lung disease are horrified if they learn that the tobacco industry are now profiting from inhaled medications too​[6]​.”

He adds that, with many inhalers available, there is “no reason to start anyone on a tobacco industry-linked one” and that most people are able to switch to an alternative if they want to.

But it is also the case that switching an inhaler is not a straightforward issue, he points out. Having the knowledge and motivation is one thing, but it also requires time and attention to detail.

Given shortages among respiratory clinicians, GPs and nurses, as well as time pressures across the health service, it is also true that most people with lung disease are missing out on many aspects of basic care, he says.

“This includes reviews of their medication, self-management and inhaler technique,” says Hopkinson. “Without an adequate respiratory workforce resourced to deliver basic care, it’s to be expected that prescriptions don’t change much.”

Informed decision

Toby Capstick, consultant pharmacist in respiratory medicine at Leeds Teaching Hospitals NHS Trust, is another outspoken critic of the takeover, writing several articles to raise awareness of the link​[6]​.

However, he believes a blanket decision to stop using a certain inhaler or start switching everyone would be “a recipe for disaster”.

“We want to make sure we’re not working with the tobacco industry, but it is difficult because the patient is my biggest concern.”

He gives the example that he would not start someone on a Forspiro (Sandoz) or Flutiform (Mundipharma) device, but for those who come to his clinic having already been prescribed an inhaler linked to Vectura, he would not switch simply because of the link. “If I’m switching it, it’s for clinical reasons, and what’s in the patient’s interest and with their agreement as well.”

He adds that patients should be enabled to make an informed decision. “It’s about giving people that information in the same way that we should be giving people information about metered-dose inhalers having a higher carbon footprint than a dry-powder device.”

Capstick notes that there are lots of alternatives if patients want to switch. “There are 145 currently available inhalers in the UK and, for all of these, there are other generics or others in the same class.”

Some patients who Capstick has told about the link have been “almost lost for words”, whereas others simply want an inhaler that works for them.

Clarifying links

Just as switching is not always straightforward, neither is the link between inhalers and Vectura. For example, on the list of 12 Vectura-associated inhalers (see Table), there are four GSK inhalers that had a patent licence with SkyePharma, which was later bought by Vectura.

GSK was quick to “clarify” its position when Vectura was bought out by the tobacco company, pointing out that it develops, manufactures and owns all intellectual property rights for its Ellipta inhalers, adding “we are not in a partnership with Vectura”​[7]​.

It does, however, pay periodic royalties to SkyePharma for patent licences on technology relating to the use of magnesium stearate as an excipient in its Ellipta inhalers. GSK confirmed to The Pharmaceutical Journal that the licence is due to expire “within the next year” and “will not be renewed or extended”.

The GSK inhalers account for around 8% of the Vectura-associated inhalers prescribed in March 2024, but 86% of the overall spend; experts note that removing them would leave a smaller list of inhalers, which prescribers may choose to avoid.

Capstick points out that some companies appear to have much closer ties with Vectura than others. While GSK will be cutting its links, Mundipharma announced joint plans with Vectura in April 2024 to work on a more carbon-friendly version of its Flutiform inhaler​[8]​.

In a statement, the two companies said they had entered a “collaboration agreement” to work on incorporating an environmentally-friendly propellant into the Flutiform pressurised metered-dose inhaler, adding that their aim is to create a near-zero-emissions product.

NHS prescriptions for Flutiform fell from almost 43,000 per month in September 2021 to 29,500 in March 2024. However, Capstick says there may be pharmacological reasons for this decrease, with better steroids for treating asthma on the market.

“I think GSK has been the most open in my opinion and I think that’s possibly because its contract was always time limited. But some of the other companies, when I’ve asked them for information, have not been as forthcoming, which suggests to me they’re more locked in.”

In a statement, Mundipharma told The Pharmaceutical Journal it has been working in partnership with Vectura since September 2006 to develop, register, market, distribute and sell Flutiform.

“We understand from the PMI ‘Integrated Report 2023’, while Vectura is owned by PMI, it is operationally separate from other PMI businesses. Furthermore, revenues generated by Vectura are reinvested into its wellness and healthcare business​[9]​.”

A spokesperson for Novartis, which makes use of Vectura-patented technology in its Seebri, Ultibro, and Enerzair Breezhaler devices, says: “We recognise the negative role tobacco plays in respiratory health and the concern about a tobacco entity becoming involved in providing technology that helps treat patients with serious respiratory conditions.

“Our priority is to ensure patients can continue to access effective medicines with no disruption to treatment, therefore we will need to continue to use Vectura’s technology whilst continuing to assess our future options.”

Prescribing behaviour

Capstick says that some of the reduction in prescribing of individual inhalers within those linked to Vectura will relate to changes to guidelines, such as from the National Institute for Health and Care Excellence and the Global Initiative for Chronic Obstructive Lung Disease, including the recommendation to use a combination long-acting beta agonist and long-acting muscarinic antagonist inhaler over a single long-acting bronchodilator. He adds that some inhalers are marketed more heavily than others, which could also impact prescribing.

In West Yorkshire, a note has been added to prescribing guidelines for asthma and chronic obstructive pulmonary disease about inhalers and the tobacco industry, which advises patients should be made aware about the links​[10]​. However, Capstick is not aware of any moves by formularies to restrict devices for this reason. “I suspect there are some concerns about reducing patient choice and resulting script switches, which could worsen control.”

Katherine Hickman, GP and respiratory lead for West Yorkshire Integrated Care Board, as well as chair of the Primary Care Respiratory Society, says that, although there was outrage about PMI buying an inhaler company among those interested in respiratory disease, most GPs would have no idea.

“I got very passionate about it, very angry about it, and I told all my colleagues, but within the broader context of asthma care they don’t have the headspace to remember which inhaler is which.” Hickman adds that she rarely brings the link up with patients because there is always a risk that they are then concerned they are getting an inferior product or somehow decisions are being made that are not about their care.

“The only way to sort this out is at government level, the onus cannot be on the individual prescriber. I still look … up [inhalers] every time and, if I’m doing that, there is no way others would remember or know.” Her main frustration is that the takeover was allowed to happen in the first place.

Capstick says he does have some sympathy for Vectura, but adds that the buyout raises questions for other pharmaceutical companies that could find themselves in a similar position. “You have to ask how you protect yourself against that.”

Darush Attar-Zadeh, clinical fellow respiratory pharmacist at the North West London Integrated Care Board, agrees it is a complicated picture, with prescribers already trying to balance the right device for the patient with regards to inhaler technique, but also to meet NHS carbon goals.

The focus on reducing the carbon footprint of NHS-prescribed inhalers has dominated the conversation and Attar-Zadeh predicts that would have had a far greater impact on prescribing decisions than links with the tobacco industry.

“What we’re hoping is that, each area across the country, when they are developing prescribing advice, is factoring in [information on] Vectura inhalers, we certainly are in north-west London.

“You can tackle both, but you need to be an inhaler guru and have real know how,” he adds.

He gives the example of newly licensed inhaled corticosteroid/formeterol combination treatments in people aged over 12 years. WockAIR (Wockhardt) is a dry powder inhaler and cheaper than the two available alternatives — AstraZeneca’s Symbicort and Teva’s DuoResp Spiromax. In theory, he notes, WockAIR could save a lot of money across an integrated care board, if you were not taking its Vectura link into account.

“I wouldn’t expect everyone to be aware of this detail. There almost needs to be a text box that pops up when you’re prescribing.”

Attar-Zadeh thinks it is possible for the NHS to take a stronger stance like it has for setting net-zero carbon ambitions for the health service. “Almost like we do for the carbon footprint symbol, in prescribing guidance, we could have a picture of cigarettes beside the inhaler devices.”

A spokesperson for PMI told The Pharmaceutical Journal in a statement: “Vectura Fertin Pharma [which brings together Vectura, Fertin Pharma and OtiTopic] is developing a pipeline of products to support PMI’s ambition to explore adjacent avenues of growth beyond smoke-free products.

“It is operationally separate from other businesses owned by PMI and has its own executive leadership team overseeing day-to-day operations and dedicated governance for projects.

“The revenues generated by Vectura Fertin Pharma are reinvested into the wellness and healthcare business.”

The Department of Health and Social Care failed to respond to a request for comment in time for publication.