Tag Archives: cost

Extreme oncology in Romania

Geta Roman is a Bucharest-based freelance journalist writing about history and medicine. For more than 10 years she was a health editor for Romanian newspapers Cotidianul and Evenimentul Zilei

Geta Roman is a Bucharest-based freelance journalist writing about history and medicine. For more than 10 years she was a health editor for Romanian newspapers Cotidianul and Evenimentul Zilei

Being an oncologist in Romania is an extreme job. Being a patient with cancer in Romania is an extreme experience.

We have 250 oncologists to care for at least 500,000 people with cancer (the figures are uncertain because the National Cancer Registry is not up and running). Our hospitals are crowded, we lack medication, many patients waiting for chemotherapy or radiotherapy, and doctors and nurses are overwhelmed. At the same time, oncology is a field rife with corruption, with the patient caught in the middle.

The National Health Insurance and Ministry of Health are trying to find solutions: more money has been offered to doctors who work in emergency departments, and the private sector is now involved in providing radiotherapy and chemotherapy treatments, paid for by National Health Insurance. But it’s nowhere near enough to resolve the crisis in our cancer services.

The young doctors who are preparing to take the place of the older generation when they retire, and the older doctors who are forced to care for more patients than they can handle, propose the same solution for resolving this crisis: more money for doctors’ salaries, to keep them from leaving the country.

An experienced oncologist earns around €1,000 per month working in the public health system, while the younger ones earn only around €300-400 depending on their experience.

Flori Vladutescu is a Resident doctor in her second year in one of the biggest hospital in the country. She chose to become one because of the impact of cancer on her own life: her mother died from breast cancer when Flori was only four years old, and in the past years she has given close support to her sister, who was diagnosed with stage III breast cancer. She would like to know whether they have the breast cancer gene mutation, but the tests are too expensive, and are not covered by the public system.

Right now, Flori has decided to stay in Romania to care for people with cancer. She’s been promised a job in Giurgiu, 60 km from her hometown, Bucharest. “Cancer patient are special, more sensitive, you have to work with them to solve the physical problems, but you need a special attitude. I learnt that from my oncology teachers, who are also different – nicer, more human…” says Flori.

Initially she had intended to leave the country after finishing her residency. But she changed her mind, and is set on taking the job in Gurgui. “I’ve already gone there. I met the doctor who I will work with, and I saw all those patients who need help. I felt for them.” Her biggest challenge, she says, will be how to manage financially. “Half my salary will go on petrol, if I choose to commute from Bucharest every day” She think she may look for somewhere more local to stay.

“Half my salary will go on petrol”

The doctor in charge of the oncology outpatient clinic in Giurgiu, Florin Onisim, says that poor organisation ends up wasting doctors’ time, making an impossible job even more impossible. A new system of electronic registration was implemented over the past year, but no additional staff were recruited to input all the data. “It is extremely bureaucratic,” says Onisim. Before this system, I was able to see 70 people daily, now only around 30–35,” he says.

People living in and around Giurgiu are relatively lucky in one respect – they live not far from Bucharest, which has the biggest concentration of public and private cancer services in the country, so most of them have the option to travel to find an expert.

The situation is worse in other parts of the country. In Vaslui, one of the poorest cities, along the eastern border of Romania, the county hospital – which caters for a population of 375,000 – has no oncologist at all. In Resita, a city with 65,000 people, in the west part of Romania, the only oncologist in the area is responsible for the more than 8,000 patients recorded in the cancer registry.

Every time the local authorities try to hire oncologists, they face the same obstacle: no doctors are interested in going there, because of the low salaries offered by public hospitals. They prefer to join the exodus of more than 10,000 doctors who have gone to work in other European countries since 2007, when Romania became an EU member. Or they stay and work in the private sector in Romania.

The solution to both is better payments for doctors.

Cancer patients receiving chemotherapy at a major Bucharest hospital

Cancer patients receiving chemotherapy at a major Bucharest hospital

“The purse is closed!” – this is no way to run a hospital

Rosa Giuliani, medical oncologist, S. Camillo-Forlanini Hospital, Rome, Italy

Rosa Giuliani, medical oncologist, S. Camillo-Forlanini Hospital, Rome, Italy

 

As a medical oncologist my primary interest is in helping patients to live longer and better. The best part of my job is the integration of clinical and molecular views: see the problem in the clinic, look for answers in the lab, bring back the solution to patients. I wish it could be as simple as that.

Research & development have a price, which is often difficult to understand. Why new drugs and devices cost that much, and not a penny less, is a complicated conundrum for many of us. The EU regulatory and reimbursement systems, the lack of a universal health policy through Europe and the profound economic crisis are regularly debated.

While I was at ECCO participating in debates on the need to promote equity and defeat disparities in access to precision medicine in Europe, hospital managers where I work notified the oncology department that the budget allocated to cancer drugs expenditure was over:no “expensive” drugs could be purchased until the budget for the new year will be discussed in January. The purse was closed. Meetings followed, some very unpleasant; poor use of resources by medical staff was implied, not even too subtly. Of course, this prompted self-examination: am I a good oncologist? Am I following guidelines? Am I spending money for my pleasure to give drugs?

After this last question, I realized that I was losing my mind and luckily, I returned to my senses. I respect rules, I need rules, I love rules. I appreciate fair rules. Budget negotiations at local hospitals are as obscure as the procedure of setting prices at EU or national level. A rule, which lacks of transparency, is not fair. The fact that the rules are set and dealt by people who are not prepared to manage the process, is terribly wrong. The overwhelming gap between cancer politics at EU Headquarters, where precision medicine is being promoted, and cancer politics at local level, where the only interest is that 2+2 should be equal to 3, because 4 is already too expensive, is frightening.

Money is an important part of the equation: resources are not infinite and their rational employment is of utmost importance. The process of drug development is not cost-effective, and many managers are not, because they have not been adequately prepared to deal with a different type of economy. Cancer medicine cannot be dealt as if providing water or electricity.

The global curriculum for being a good medical oncologist has dramatically changed in the past 10 years. Medical oncologists in 2015 cannot neglect molecular biology, health policies, precision medicine and so on. The same change should happen with managers who allocate resources for health politics, especially at hospital level. Being a good accountant does not suffice anymore, just as being exclusively a good clinician is not enough. Another level of knowledge and preparation is needed. And honestly, sometimes, a little bit of emotional intelligence would not do any harm.

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Smoke gets in your eyes

Simon Crompton

Simon Crompton

The title of Europa Donna’s annual London symposium last week was “New directions in breast cancer”. By the end of the evening, possible new directions were clear, but the route to take was not.

One of the two speakers was Daniel Leff, a cancer surgeon from Imperial College London, who addressed the difficulties of defining the correct margins when surgically removing breast cancer. The object had to be, he said, reducing the chances of reoperation.

He tantalised the audience with the question: “Can surgical smoke be informative?”

Potential of spectrometer analysis

Researchers at Imperial have used mass spectrometers to analyse the smoke arising from tissue incision with electrosurgical knives – a technique known as Rapid Evaporative Ionisation Mass Spectrometry (REIMS). Different types of cell produce different chemical concentrations when burned, so the chemical profile can indicate whether the tissue being cut is cancerous or not.

Identification of cancerous tissue using the technique during surgery, said Leff, was 93% accurate.

It’s a truly impressive technological development, that has potential to radically reduce reoperation rates for breast cancer.

The cost question

But how much did the machinery cost, asked a member of the audience? Half a million pounds, answered Leff. And how much did a pathologist cost? The answer was not given, but the point was made…

Pathologists already have advanced (and cheaper) techniques which can accurately indicate to surgeons which areas are cancerous and which are not. The question, said audience members, was why they were not being used. Leff himself acknowledged that pathology analysis using frozen section and touch imprint cytology were highly effective ways of determining the extent of breast disease and reducing the need for re-excision. But they are not widely used in the UK.

Novelty intoxication

On the systemic therapy side, Stephen Johnston, Professor of Breast Cancer Medicine at the Royal Marsden Hospital, spoke of the real promise of the drug Palbociclib as a first-line treatment for ER-positive breast cancer, and (in combination with Fulvestrant) as a second-line treatment as well. The cost of Palbociclib? Around £90,000 for one year’s treatment. The pressing question of how such expensive drugs are to be made widely available was raised, but not addressed.

New directions in breast cancer are exciting, involving, often inspiring. But we know how easy it is to become intoxicated with novelty and infatuated with technology. Sometimes, it isn’t new directions we need to hear about, but what is already here but under-utilised – and how we can best use what is proven, affordable and practicable to benefit the greatest number of women possible, as soon as possible.

Europa Donna, the European Breast Cancer Coalition, has a Facebook page.

 

 

 

 

 

Turning targets into effective treatments. My three questions for the World Oncology Forum

 

Paul Workman

Paul Workman

This week 50 experts from across the globe involved in researching, developing, evaluating and delivering new therapies will meet to develop consensus recommendations on who needs to do what to speed the development of effective treatments. The meeting is one of a series of World Oncology Forum summits organised by ESO in collaboration with The Lancet.  

In this guest blogpost, Paul Workman, interim CEO of The Institute of Cancer Research, London, talks about the three questions he will be posing in his opening keynote speech.

AS SOMEONE WHO has spent a career in cancer drug discovery and development, in academic, biotech and big pharma settings, I find it very frustrating that we still lack the treatments we need to effectively control or cure many cancers.

So I welcome the opportunity to give the opening presentation at WOF 2014, and to ask questions about what has to happen to translate the tremendous insight and knowledge we now have about the genetics and biology of cancer into effective treatments.

I intend to open on an optimistic note.

The success of the human genome project and its application to oncology has led over the past decade to an extraordinary increase in our understanding of the causation of cancer, and has opened up a new, ‘personalised’ approach to treating cancer.

There is a feeling of positivity among cancer researchers which I certainly share. Genetics and biology are being laid open, and ideas about rational therapies are still pouring out of labs.

It’s true that, while some of the new personalised therapies have been very successful, the overall impact so far has been disappointing. But an important point I will be stressing is that we do understand what the limitations are – and based on this we can now devise scientifically rational ways forward to move us to the next level.

We now know that cancers are able to develop resistance to molecularly targeted drug treatments – just as they did to the previous generation of cytotoxic drugs. This is because cancer cells evolve over time through a sort of Darwinian ‘survival of the nastiest’.

Such evolution leads to the high level of genetic and biological variation of cancer cells within a given patient. Even worse, the treatments given can themselves act as a ‘selective pressure’ to drive further variation and resistance.

So the task ahead is ideally to design therapies that will block cancer evolution. One class of drugs that does this that we at the ICR have been heavily involved in developing – HSP90 inhibitors – are now in clinical trial. We need to find more targets of this type, for example those in epigenetic regulatory pathways.

Another important approach to overcome evolution and resistance is to develop drug combinations that can hit, for example, several different cancer targets or other alterations at the same time – a strategy which has worked well in controlling HIV.

But this is where we come up against a problem. Because, out of the 500 genes or so we have discovered that are responsible for causing cancer, we’ve only got drugs that will work against about 5% of them.

We still haven’t got any drugs that work, for instance, on RAS or on MYC or p53 – three of the big genes responsible for causing cancer. So we’re trying to find effective combinations when we have no drugs for 95% of genes that may be involved in resistance. There is a huge amount of work still to do in this key area.

Question 1
So a key question I will be posing at the World Oncology Forum will be: how do we speed up the development of innovative drugs against more of these new cancer targets?

Part of the answer to this problem involves the technical challenges to find drugs for the less ‘druggable’ targets. But in fact there is another more systematic problem which lies in the ‘ecosystem’ that governs the way new therapies are discovered, developed, brought to market and paid for. It clearly isn’t functioning as well as it should for developing personalised cancer therapies.

Most companies are working on a relatively small number of targets, maybe 20 or 30. They all tend to invest in the same group of targets and often they prefer trying to develop a slightly better version of a drug that is already out there rather than going for a new target.

Taking a higher-risk, more innovative approach and working on currently undrugged targets, rather than developing ‘me-too’ drugs, is much more likely to deliver the sort of step changes in survival that we all want to see.

The risk-aversion that predominates in the pharma industry is understandable, from their point of view. They know that historically only 5–10% of drugs that enter phase I show enough activity to be approved, so they want to be very sure about the targets they work on.

But that thinking creates an innovation gap, or what we call rather more dramatically the ‘valley of death’. There is a gap – in fact a chasm –  between early-stage research with real clinical implications, like the identification of a new target gene, or the discovery of a an early prototype drug candidate, and it being taken forward by companies to the point where a treatment can be trialled in patients.

Then there’s the problem that new drugs are being tested in settings where they are least likely to show a benefit, as single treatments given in late-stage disease which has already become drug resistant.

Even though we now have predictive biomarkers to select responsive patients, the benefit in heavily treated drug-resistant patients can be relatively small, which means that it takes more patients and a longer time to demonstrate in a clinical trial. This pushes up costs, which then means that bodies like NICE in the UK and its equivalents elsewhere may refuse to fund the drugs because they aren’t deemed sufficient value for money.

This is not helped by companies continuing to seek the maximum cost the market will bear. And once a drug has been turned down it becomes very difficult to find out what it might be capable of when used either earlier in the disease or in combination with other drugs. So great opportunities will be lost.

Question 2
So the second question I will be asking is, how can we incentivise the ecosystem to be more innovative in research and development?

I think the key to progress is all about decreasing risk aversion. Until now, the pharmaceutical industry has preferred to stick to tried and tested ways of discovering drugs and of steering them through the regulatory process – even though there may be strong scientific grounds for doing things differently when we’re dealing with rationally designed, targeted therapies and especially facing the challenge of cancer evolution and drug resistance.

It’s easy but fruitless to get into the blame game here. Pharmaceutical companies are not charities and they have a responsibility to their shareholders. Bodies like NICE have a responsibility to ensure health spending delivers value for money and regulators need to be convinced of the medical merits and safety of new therapies.

The question is how to find a way forward that works better for everybody.

If we accept that risk aversion is a big part of the problem – an assumption that is backed up by many conversations I have had and by my own experience in the industry – we have to find ways to bridge the innovation gap.

One way is to do more of the early high-risk drug discovery and development in the academic sphere, and in collaborations with Government, charities and industry.

Some organisations, such as Cancer Research UK and the National Institutes for Health in the US, are already pushing for this approach. They are beginning to provide ‘valley of death’-type funding to academic groups, including mine here at the ICR and MD Anderson and others, to help them get involved in early-stage, high-risk, innovative drug discovery and development. That can decrease the risk to industry in progressing a new approach.

I think this approach will really help, as exemplified by the breakthrough drug abiraterone that we discovered at the ICR and which was then subsequently licensed to industry and approved in late-stage prostate cancer.

We should be aware though that risk-aversion is not restricted to industry. There are many pressures at work in the academic sector – including hyper-competition, difficulties in accessing grant funding, and a preference for funding ‘safe’ rather than highly innovative approaches.

We also have to face tough questions about excessive requirements for publication which can actually slow progress and reduce efficiency. And conversely there are worries about the inability to replicate many academic discoveries in basic research which can then misinform choices about the best therapeutic targets to work on.

Question 3
So the final questions I will be pushing very hard at the end of my presentation will be: How do we de-risk innovative drug development for companies? Where will the high-risk work be done? Who will fund it? And what should we expect from companies and academia?

It is going to require concerted efforts from all parts of the ecosystem to overcome the challenges we face to overcome cancer evolution and drug resistance. We need to work together as a community to find win-win solutions.

I’m looking forward to the discussions at the Forum and believe they will help move us in the right direction.

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