Servier and French drug safety agency found guilty on diet drug

Article Type
Changed
Tue, 05/03/2022 - 15:06

 

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

 

 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

 

 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

A version of this article first appeared on Medscape.com.

 

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

 

 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads

Are oncologists ready to confront a second wave of COVID-19?

Article Type
Changed
Thu, 12/15/2022 - 17:33

Canceled appointments, postponed surgeries, and delayed cancer diagnoses – all are a recipe for exhaustion for oncologists around the world, struggling to reach and treat their patients during the pandemic. Physicians and their teams felt the pain as COVID-19 took its initial march around the globe.

“We saw the distress of people with cancer who could no longer get to anyone on the phone. Their medical visit was usually canceled. Their radiotherapy session was postponed or modified, and chemotherapy postponed,” says Axel Kahn, MD, chairman of the board of directors of La Ligue Nationale Contre le Cancer (National League Against Cancer). “In the vast majority of cases, cancer treatment can be postponed or readjusted, without affecting the patient’s chances of survival, but there has been a lot of anxiety because the patients do not know that.”

The stay-at-home factor was one that played out across many months during the first wave.

“I believe that the ‘stay-home’ message that we transmitted was rigorously followed by patients who should have come to the emergency room much earlier and who, therefore, were admitted with a much more deteriorated general condition than in non-COVID-19 times,” says Benjamín Domingo Arrué, MD, from the department of medical oncology at Hospital Universitari i Politècnic La Fe in Valencia, Spain.

And in Brazil, some of the impact from the initial hit of COVID-19 on oncology is only now being felt, according to Laura Testa, MD, head of breast medical oncology, Instituto do Câncer do Estado de São Paulo.

“We are starting to see a lot of cancer cases that didn’t show up at the beginning of the pandemic, but now they are arriving to us already in advanced stages,” she said. “These patients need hospital care. If the situation worsens and goes back to what we saw at the peak of the curve, I fear the public system won’t be able to treat properly the oncology patients that need hospital care and the patients with cancer who also have COVID-19.”

But even as health care worker fatigue and concerns linger, oncologists say that what they have learned in the last 6 months has helped them prepare as COVID-19 cases increase and a second global wave kicks up.
 

Lessons from the first wave

In the United States, COVID-19 hit different regions at different times and to different degrees. One of the areas hit first was Seattle.

“We jumped on top of this, we were evidence based, we put things in place very, very quickly,” said Julie Gralow, MD, professor at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.

“We did a really good job keeping COVID out of our cancer centers,” Dr. Gralow said. “We learned how to be super safe, and to keep symptomatic people out of the building, and to limit the extra people they could bring with them. It’s all about the number of contacts you have.”

The story was different, though, for oncologists in several other countries, and sometimes it varied immensely within each nation.

“We treated fewer patients with cancer during the first wave,” says Dirk Arnold, MD, medical director of the Asklepios Tumor Center Hamburg (Germany), in an interview. “In part, this was because staff were quarantined and because we had a completely different infrastructure in all of the hospitals. But also fewer patients with cancer came to the clinic at all. A lot of resources were directed toward COVID-19.” 

In Spain, telemedicine helped keep up with visits, but other areas felt the effect of COVID-19 patient loads.

“At least in the oncology department of our center, we have practically maintained 100% of visits, mostly by telephone,” says Dr. Arrué, “but the reality is that our country has not yet been prepared for telemedicine.”

Laura Mezquita, MD, of the department of medical oncology at Hospital Clinic de Barcelona, describes a more dramatic situation: “We have seen how some of our patients, especially with metastatic disease, have been dismissed for intensive care and life-support treatments, as well as specific treatments against COVID-19 (tocilizumab, remdesivir, etc.) due to the general health collapse of the former wave,” she said. She adds that specific oncologic populations, such as those with thoracic tumors, have been more affected.
 

 

 

Distress among oncologists 

Many oncologists are still feeling stressed and fatigued after the first wave, just as a second string of outbreaks is on its way. 

survey presented at last month’s ESMO 2020 Congress found that, in July-August, moral distress was reported by one-third of the oncologists who responded, and more than half reported a feeling of exhaustion. 

“The tiredness and team exhaustion is noticeable,” said Dr. Arnold. “We recently had a task force discussion about what will happen when we have a second wave and how the department and our services will adapt. It was clear that those who were at the very front in the first wave had only a limited desire to do that again in the second wave.”

Another concern: COVID-19’s effect on staffing levels. 

“We have a population of young caregivers who are affected by the COVID-19 disease with an absenteeism rate that is quite unprecedented,” said Sophie Beaupère, general delegate of Unicancer since January.

She said that, in general, the absenteeism rate in the cancer centers averages 5%-6%, depending on the year. But that rate is now skyrocketing.
 

Stop-start cycle for surgery

As caregivers quarantined around the world, more than 10% of patients with cancer had treatment canceled or delayed during the first wave of the pandemic, according to another survey from ESMO, involving 109 oncologists from 18 countries.

Difficulties were reported for surgeries by 34% of the centers, but also difficulties with delivering chemotherapy (22% of centers), radiotherapy (13.7%), and therapy with checkpoint inhibitors (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Stopping surgery is a real concern in France, noted Dr. Kahn, the National League Against Cancer chair. He says that in regions that were badly hit by COVID-19, “it was not possible to have access to the operating room for people who absolutely needed surgery; for example, patients with lung cancer that was still operable. Most of the recovery rooms were mobilized for resuscitation.”

There may be some solutions, suggested Thierry Breton, director general of the National Institute of Cancer in France. “We are getting prepared, with the health ministry, for a possible increase in hospital tension, which would lead to a situation where we would have to reschedule operations. Nationally, regionally, and locally, we are seeing how we can resume and prioritize surgeries that have not been done.”
 

Delays in cancer diagnosis

While COVID-19 affected treatment, many oncologists say the major impact of the first wave was a delay in diagnosing cancer. Some of this was a result of the suspension of cancer screening programs, but there was also fear among the general public about visiting clinics and hospitals during a pandemic.

“We didn’t do so well with cancer during the first wave here in the U.K.,” said Karol Sikora, PhD, MBBChir, professor of cancer medicine and founding dean at the University of Buckingham Medical School, London. “Cancer diagnostic pathways virtually stalled partly because patients didn’t seek help, but getting scans and biopsies was also very difficult. Even patients referred urgently under the ‘2-weeks-wait’ rule were turned down.” 

In France, “the delay in diagnosis is indisputable,” said Dr. Kahn. “About 50% of the cancer diagnoses one would expect during this period were missed.” 

“I am worried that there remains a major traffic jam that has not been caught up with, and, in the meantime, the health crisis is worsening,” he added.  

In Seattle, Dr. Gralow said the first COVID-19 wave had little impact on treatment for breast cancer, but it was in screening for breast cancer “where things really got messed up.”

“Even though we’ve been fully ramped up again,” she said, concerns remain. To ensure that screening mammography is maintained, “we have spaced out the visits to keep our waiting rooms less populated, with a longer time between using the machine so we can clean it. To do this, we have extended operating hours and are now opening on Saturday.

“So we’re actually at 100% of our capacity, but I’m really nervous, though, that a lot of people put off their screening mammogram and aren’t going to come in and get it.

“Not only did people get the message to stay home and not do nonessential things, but I think a lot of people lost their health insurance when they lost their jobs,” she said, and without health insurance, they are not covered for cancer screening.
 

 

 

Looking ahead, with a plan

Many oncologists agree that access to care can and must be improved – and there were some positive moves.

“Some regimens changed during the first months of the pandemic, and I don’t see them going back to the way they were anytime soon,” said Dr. Testa. “The changes/adaptations that were made to minimize the chance of SARS-CoV-2 infection are still in place and will go on for a while. In this context, telemedicine helped a lot. The pandemic forced the stakeholders to step up and put it in place in March. And now it’s here to stay.”

The experience gained in the last several months has driven preparation for the next wave.

“We are not going to see the disorganization that we saw during the first wave,” said Florence Joly, MD, PhD, head of medical oncology at the Centre François Baclesse in Caen, France. “The difference between now and earlier this year is that COVID diagnostic tests are available. That was one of the problems in the first wave. We had no way to diagnose.”

On the East Coast of the United States, medical oncologist Charu Aggarwal, MD, MPH, is also optimistic: “I think we’re at a place where we can manage.”

“I believe if there was going to be a new wave of COVID-19 cases we would be: better psychologically prepared and better organized,” said Dr. Aggarwal, assistant professor of medicine in the hematology-oncology division at the University of Pennsylvania, Philadelphia. “We already have experience with all of the tools, we have telemedicine available, we have screening protocols available, we have testing, we are already universally masking, everyone’s hand-washing, so I do think that means we would be okay.” 

Dr. Arnold agreed that “we are much better prepared than for the first wave, but … we have immense tasks in the area of patient management, the digitization of patient care, the clear allocation of resources when there is a second or third wave. In many areas of preparation, I believe, unfortunately, we are not as well positioned as we had actually hoped.” 

The first wave of COVID hit cancer services in the United Kingdom particularly hard: One modeling study suggested that delays in cancer referrals will lead to thousands of additional deaths and tens of thousands of life-years lost.

“Cancer services are working at near normal levels now, but they are still fragile and could be severely compromised again if the NHS [National Health Service] gets flooded by COVID patients,” said Dr. Sikora.

The second wave may be different. “Although the number of infections has increased, the hospitalizations have only risen a little. Let’s see what happens,” he said in an interview. Since then, however, infections have continued to rise, and there has been an increase in hospitalizations. New social distancing measures in the United Kingdom were put into place on Oct. 12, with the aim of protecting the NHS from overload.

Dr. Arrué describes it this way: “The reality is that the ‘second wave’ has left behind the initial grief and shock that both patients and health professionals experienced when faced with something that, until now, we had only seen in the movies.” The second wave has led to new restrictions – including a partial lockdown since the beginning of October.

Dr. Aggarwal says her department recently had a conference with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, about the impact of COVID-19 on oncology.

“I asked him what advice he’d give oncologists, and he said to go back to as much screening as you were doing previously as quickly as possible. That’s what must be relayed to our oncologists in the community – and also to primary care physicians – because they are often the ones who are ordering and championing the screening efforts.”

This article was originated by Aude Lecrubier, Medscape French edition, and developed by Zosia Chustecka, Medscape Oncology. With additional reporting by Kate Johnson, freelance medical journalist, Claudia Gottschling for Medscape Germany, Leoleli Schwartz for Medscape em português, Tim Locke for Medscape United Kingdom, and Carla Nieto Martínez, freelance medical journalist for Medscape Spanish edition. 

This article first appeared on Medscape.com.

Publications
Topics
Sections

Canceled appointments, postponed surgeries, and delayed cancer diagnoses – all are a recipe for exhaustion for oncologists around the world, struggling to reach and treat their patients during the pandemic. Physicians and their teams felt the pain as COVID-19 took its initial march around the globe.

“We saw the distress of people with cancer who could no longer get to anyone on the phone. Their medical visit was usually canceled. Their radiotherapy session was postponed or modified, and chemotherapy postponed,” says Axel Kahn, MD, chairman of the board of directors of La Ligue Nationale Contre le Cancer (National League Against Cancer). “In the vast majority of cases, cancer treatment can be postponed or readjusted, without affecting the patient’s chances of survival, but there has been a lot of anxiety because the patients do not know that.”

The stay-at-home factor was one that played out across many months during the first wave.

“I believe that the ‘stay-home’ message that we transmitted was rigorously followed by patients who should have come to the emergency room much earlier and who, therefore, were admitted with a much more deteriorated general condition than in non-COVID-19 times,” says Benjamín Domingo Arrué, MD, from the department of medical oncology at Hospital Universitari i Politècnic La Fe in Valencia, Spain.

And in Brazil, some of the impact from the initial hit of COVID-19 on oncology is only now being felt, according to Laura Testa, MD, head of breast medical oncology, Instituto do Câncer do Estado de São Paulo.

“We are starting to see a lot of cancer cases that didn’t show up at the beginning of the pandemic, but now they are arriving to us already in advanced stages,” she said. “These patients need hospital care. If the situation worsens and goes back to what we saw at the peak of the curve, I fear the public system won’t be able to treat properly the oncology patients that need hospital care and the patients with cancer who also have COVID-19.”

But even as health care worker fatigue and concerns linger, oncologists say that what they have learned in the last 6 months has helped them prepare as COVID-19 cases increase and a second global wave kicks up.
 

Lessons from the first wave

In the United States, COVID-19 hit different regions at different times and to different degrees. One of the areas hit first was Seattle.

“We jumped on top of this, we were evidence based, we put things in place very, very quickly,” said Julie Gralow, MD, professor at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.

“We did a really good job keeping COVID out of our cancer centers,” Dr. Gralow said. “We learned how to be super safe, and to keep symptomatic people out of the building, and to limit the extra people they could bring with them. It’s all about the number of contacts you have.”

The story was different, though, for oncologists in several other countries, and sometimes it varied immensely within each nation.

“We treated fewer patients with cancer during the first wave,” says Dirk Arnold, MD, medical director of the Asklepios Tumor Center Hamburg (Germany), in an interview. “In part, this was because staff were quarantined and because we had a completely different infrastructure in all of the hospitals. But also fewer patients with cancer came to the clinic at all. A lot of resources were directed toward COVID-19.” 

In Spain, telemedicine helped keep up with visits, but other areas felt the effect of COVID-19 patient loads.

“At least in the oncology department of our center, we have practically maintained 100% of visits, mostly by telephone,” says Dr. Arrué, “but the reality is that our country has not yet been prepared for telemedicine.”

Laura Mezquita, MD, of the department of medical oncology at Hospital Clinic de Barcelona, describes a more dramatic situation: “We have seen how some of our patients, especially with metastatic disease, have been dismissed for intensive care and life-support treatments, as well as specific treatments against COVID-19 (tocilizumab, remdesivir, etc.) due to the general health collapse of the former wave,” she said. She adds that specific oncologic populations, such as those with thoracic tumors, have been more affected.
 

 

 

Distress among oncologists 

Many oncologists are still feeling stressed and fatigued after the first wave, just as a second string of outbreaks is on its way. 

survey presented at last month’s ESMO 2020 Congress found that, in July-August, moral distress was reported by one-third of the oncologists who responded, and more than half reported a feeling of exhaustion. 

“The tiredness and team exhaustion is noticeable,” said Dr. Arnold. “We recently had a task force discussion about what will happen when we have a second wave and how the department and our services will adapt. It was clear that those who were at the very front in the first wave had only a limited desire to do that again in the second wave.”

Another concern: COVID-19’s effect on staffing levels. 

“We have a population of young caregivers who are affected by the COVID-19 disease with an absenteeism rate that is quite unprecedented,” said Sophie Beaupère, general delegate of Unicancer since January.

She said that, in general, the absenteeism rate in the cancer centers averages 5%-6%, depending on the year. But that rate is now skyrocketing.
 

Stop-start cycle for surgery

As caregivers quarantined around the world, more than 10% of patients with cancer had treatment canceled or delayed during the first wave of the pandemic, according to another survey from ESMO, involving 109 oncologists from 18 countries.

Difficulties were reported for surgeries by 34% of the centers, but also difficulties with delivering chemotherapy (22% of centers), radiotherapy (13.7%), and therapy with checkpoint inhibitors (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Stopping surgery is a real concern in France, noted Dr. Kahn, the National League Against Cancer chair. He says that in regions that were badly hit by COVID-19, “it was not possible to have access to the operating room for people who absolutely needed surgery; for example, patients with lung cancer that was still operable. Most of the recovery rooms were mobilized for resuscitation.”

There may be some solutions, suggested Thierry Breton, director general of the National Institute of Cancer in France. “We are getting prepared, with the health ministry, for a possible increase in hospital tension, which would lead to a situation where we would have to reschedule operations. Nationally, regionally, and locally, we are seeing how we can resume and prioritize surgeries that have not been done.”
 

Delays in cancer diagnosis

While COVID-19 affected treatment, many oncologists say the major impact of the first wave was a delay in diagnosing cancer. Some of this was a result of the suspension of cancer screening programs, but there was also fear among the general public about visiting clinics and hospitals during a pandemic.

“We didn’t do so well with cancer during the first wave here in the U.K.,” said Karol Sikora, PhD, MBBChir, professor of cancer medicine and founding dean at the University of Buckingham Medical School, London. “Cancer diagnostic pathways virtually stalled partly because patients didn’t seek help, but getting scans and biopsies was also very difficult. Even patients referred urgently under the ‘2-weeks-wait’ rule were turned down.” 

In France, “the delay in diagnosis is indisputable,” said Dr. Kahn. “About 50% of the cancer diagnoses one would expect during this period were missed.” 

“I am worried that there remains a major traffic jam that has not been caught up with, and, in the meantime, the health crisis is worsening,” he added.  

In Seattle, Dr. Gralow said the first COVID-19 wave had little impact on treatment for breast cancer, but it was in screening for breast cancer “where things really got messed up.”

“Even though we’ve been fully ramped up again,” she said, concerns remain. To ensure that screening mammography is maintained, “we have spaced out the visits to keep our waiting rooms less populated, with a longer time between using the machine so we can clean it. To do this, we have extended operating hours and are now opening on Saturday.

“So we’re actually at 100% of our capacity, but I’m really nervous, though, that a lot of people put off their screening mammogram and aren’t going to come in and get it.

“Not only did people get the message to stay home and not do nonessential things, but I think a lot of people lost their health insurance when they lost their jobs,” she said, and without health insurance, they are not covered for cancer screening.
 

 

 

Looking ahead, with a plan

Many oncologists agree that access to care can and must be improved – and there were some positive moves.

“Some regimens changed during the first months of the pandemic, and I don’t see them going back to the way they were anytime soon,” said Dr. Testa. “The changes/adaptations that were made to minimize the chance of SARS-CoV-2 infection are still in place and will go on for a while. In this context, telemedicine helped a lot. The pandemic forced the stakeholders to step up and put it in place in March. And now it’s here to stay.”

The experience gained in the last several months has driven preparation for the next wave.

“We are not going to see the disorganization that we saw during the first wave,” said Florence Joly, MD, PhD, head of medical oncology at the Centre François Baclesse in Caen, France. “The difference between now and earlier this year is that COVID diagnostic tests are available. That was one of the problems in the first wave. We had no way to diagnose.”

On the East Coast of the United States, medical oncologist Charu Aggarwal, MD, MPH, is also optimistic: “I think we’re at a place where we can manage.”

“I believe if there was going to be a new wave of COVID-19 cases we would be: better psychologically prepared and better organized,” said Dr. Aggarwal, assistant professor of medicine in the hematology-oncology division at the University of Pennsylvania, Philadelphia. “We already have experience with all of the tools, we have telemedicine available, we have screening protocols available, we have testing, we are already universally masking, everyone’s hand-washing, so I do think that means we would be okay.” 

Dr. Arnold agreed that “we are much better prepared than for the first wave, but … we have immense tasks in the area of patient management, the digitization of patient care, the clear allocation of resources when there is a second or third wave. In many areas of preparation, I believe, unfortunately, we are not as well positioned as we had actually hoped.” 

The first wave of COVID hit cancer services in the United Kingdom particularly hard: One modeling study suggested that delays in cancer referrals will lead to thousands of additional deaths and tens of thousands of life-years lost.

“Cancer services are working at near normal levels now, but they are still fragile and could be severely compromised again if the NHS [National Health Service] gets flooded by COVID patients,” said Dr. Sikora.

The second wave may be different. “Although the number of infections has increased, the hospitalizations have only risen a little. Let’s see what happens,” he said in an interview. Since then, however, infections have continued to rise, and there has been an increase in hospitalizations. New social distancing measures in the United Kingdom were put into place on Oct. 12, with the aim of protecting the NHS from overload.

Dr. Arrué describes it this way: “The reality is that the ‘second wave’ has left behind the initial grief and shock that both patients and health professionals experienced when faced with something that, until now, we had only seen in the movies.” The second wave has led to new restrictions – including a partial lockdown since the beginning of October.

Dr. Aggarwal says her department recently had a conference with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, about the impact of COVID-19 on oncology.

“I asked him what advice he’d give oncologists, and he said to go back to as much screening as you were doing previously as quickly as possible. That’s what must be relayed to our oncologists in the community – and also to primary care physicians – because they are often the ones who are ordering and championing the screening efforts.”

This article was originated by Aude Lecrubier, Medscape French edition, and developed by Zosia Chustecka, Medscape Oncology. With additional reporting by Kate Johnson, freelance medical journalist, Claudia Gottschling for Medscape Germany, Leoleli Schwartz for Medscape em português, Tim Locke for Medscape United Kingdom, and Carla Nieto Martínez, freelance medical journalist for Medscape Spanish edition. 

This article first appeared on Medscape.com.

Canceled appointments, postponed surgeries, and delayed cancer diagnoses – all are a recipe for exhaustion for oncologists around the world, struggling to reach and treat their patients during the pandemic. Physicians and their teams felt the pain as COVID-19 took its initial march around the globe.

“We saw the distress of people with cancer who could no longer get to anyone on the phone. Their medical visit was usually canceled. Their radiotherapy session was postponed or modified, and chemotherapy postponed,” says Axel Kahn, MD, chairman of the board of directors of La Ligue Nationale Contre le Cancer (National League Against Cancer). “In the vast majority of cases, cancer treatment can be postponed or readjusted, without affecting the patient’s chances of survival, but there has been a lot of anxiety because the patients do not know that.”

The stay-at-home factor was one that played out across many months during the first wave.

“I believe that the ‘stay-home’ message that we transmitted was rigorously followed by patients who should have come to the emergency room much earlier and who, therefore, were admitted with a much more deteriorated general condition than in non-COVID-19 times,” says Benjamín Domingo Arrué, MD, from the department of medical oncology at Hospital Universitari i Politècnic La Fe in Valencia, Spain.

And in Brazil, some of the impact from the initial hit of COVID-19 on oncology is only now being felt, according to Laura Testa, MD, head of breast medical oncology, Instituto do Câncer do Estado de São Paulo.

“We are starting to see a lot of cancer cases that didn’t show up at the beginning of the pandemic, but now they are arriving to us already in advanced stages,” she said. “These patients need hospital care. If the situation worsens and goes back to what we saw at the peak of the curve, I fear the public system won’t be able to treat properly the oncology patients that need hospital care and the patients with cancer who also have COVID-19.”

But even as health care worker fatigue and concerns linger, oncologists say that what they have learned in the last 6 months has helped them prepare as COVID-19 cases increase and a second global wave kicks up.
 

Lessons from the first wave

In the United States, COVID-19 hit different regions at different times and to different degrees. One of the areas hit first was Seattle.

“We jumped on top of this, we were evidence based, we put things in place very, very quickly,” said Julie Gralow, MD, professor at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.

“We did a really good job keeping COVID out of our cancer centers,” Dr. Gralow said. “We learned how to be super safe, and to keep symptomatic people out of the building, and to limit the extra people they could bring with them. It’s all about the number of contacts you have.”

The story was different, though, for oncologists in several other countries, and sometimes it varied immensely within each nation.

“We treated fewer patients with cancer during the first wave,” says Dirk Arnold, MD, medical director of the Asklepios Tumor Center Hamburg (Germany), in an interview. “In part, this was because staff were quarantined and because we had a completely different infrastructure in all of the hospitals. But also fewer patients with cancer came to the clinic at all. A lot of resources were directed toward COVID-19.” 

In Spain, telemedicine helped keep up with visits, but other areas felt the effect of COVID-19 patient loads.

“At least in the oncology department of our center, we have practically maintained 100% of visits, mostly by telephone,” says Dr. Arrué, “but the reality is that our country has not yet been prepared for telemedicine.”

Laura Mezquita, MD, of the department of medical oncology at Hospital Clinic de Barcelona, describes a more dramatic situation: “We have seen how some of our patients, especially with metastatic disease, have been dismissed for intensive care and life-support treatments, as well as specific treatments against COVID-19 (tocilizumab, remdesivir, etc.) due to the general health collapse of the former wave,” she said. She adds that specific oncologic populations, such as those with thoracic tumors, have been more affected.
 

 

 

Distress among oncologists 

Many oncologists are still feeling stressed and fatigued after the first wave, just as a second string of outbreaks is on its way. 

survey presented at last month’s ESMO 2020 Congress found that, in July-August, moral distress was reported by one-third of the oncologists who responded, and more than half reported a feeling of exhaustion. 

“The tiredness and team exhaustion is noticeable,” said Dr. Arnold. “We recently had a task force discussion about what will happen when we have a second wave and how the department and our services will adapt. It was clear that those who were at the very front in the first wave had only a limited desire to do that again in the second wave.”

Another concern: COVID-19’s effect on staffing levels. 

“We have a population of young caregivers who are affected by the COVID-19 disease with an absenteeism rate that is quite unprecedented,” said Sophie Beaupère, general delegate of Unicancer since January.

She said that, in general, the absenteeism rate in the cancer centers averages 5%-6%, depending on the year. But that rate is now skyrocketing.
 

Stop-start cycle for surgery

As caregivers quarantined around the world, more than 10% of patients with cancer had treatment canceled or delayed during the first wave of the pandemic, according to another survey from ESMO, involving 109 oncologists from 18 countries.

Difficulties were reported for surgeries by 34% of the centers, but also difficulties with delivering chemotherapy (22% of centers), radiotherapy (13.7%), and therapy with checkpoint inhibitors (9.1%), monoclonal antibodies (9%), and oral targeted therapy (3.7%).

Stopping surgery is a real concern in France, noted Dr. Kahn, the National League Against Cancer chair. He says that in regions that were badly hit by COVID-19, “it was not possible to have access to the operating room for people who absolutely needed surgery; for example, patients with lung cancer that was still operable. Most of the recovery rooms were mobilized for resuscitation.”

There may be some solutions, suggested Thierry Breton, director general of the National Institute of Cancer in France. “We are getting prepared, with the health ministry, for a possible increase in hospital tension, which would lead to a situation where we would have to reschedule operations. Nationally, regionally, and locally, we are seeing how we can resume and prioritize surgeries that have not been done.”
 

Delays in cancer diagnosis

While COVID-19 affected treatment, many oncologists say the major impact of the first wave was a delay in diagnosing cancer. Some of this was a result of the suspension of cancer screening programs, but there was also fear among the general public about visiting clinics and hospitals during a pandemic.

“We didn’t do so well with cancer during the first wave here in the U.K.,” said Karol Sikora, PhD, MBBChir, professor of cancer medicine and founding dean at the University of Buckingham Medical School, London. “Cancer diagnostic pathways virtually stalled partly because patients didn’t seek help, but getting scans and biopsies was also very difficult. Even patients referred urgently under the ‘2-weeks-wait’ rule were turned down.” 

In France, “the delay in diagnosis is indisputable,” said Dr. Kahn. “About 50% of the cancer diagnoses one would expect during this period were missed.” 

“I am worried that there remains a major traffic jam that has not been caught up with, and, in the meantime, the health crisis is worsening,” he added.  

In Seattle, Dr. Gralow said the first COVID-19 wave had little impact on treatment for breast cancer, but it was in screening for breast cancer “where things really got messed up.”

“Even though we’ve been fully ramped up again,” she said, concerns remain. To ensure that screening mammography is maintained, “we have spaced out the visits to keep our waiting rooms less populated, with a longer time between using the machine so we can clean it. To do this, we have extended operating hours and are now opening on Saturday.

“So we’re actually at 100% of our capacity, but I’m really nervous, though, that a lot of people put off their screening mammogram and aren’t going to come in and get it.

“Not only did people get the message to stay home and not do nonessential things, but I think a lot of people lost their health insurance when they lost their jobs,” she said, and without health insurance, they are not covered for cancer screening.
 

 

 

Looking ahead, with a plan

Many oncologists agree that access to care can and must be improved – and there were some positive moves.

“Some regimens changed during the first months of the pandemic, and I don’t see them going back to the way they were anytime soon,” said Dr. Testa. “The changes/adaptations that were made to minimize the chance of SARS-CoV-2 infection are still in place and will go on for a while. In this context, telemedicine helped a lot. The pandemic forced the stakeholders to step up and put it in place in March. And now it’s here to stay.”

The experience gained in the last several months has driven preparation for the next wave.

“We are not going to see the disorganization that we saw during the first wave,” said Florence Joly, MD, PhD, head of medical oncology at the Centre François Baclesse in Caen, France. “The difference between now and earlier this year is that COVID diagnostic tests are available. That was one of the problems in the first wave. We had no way to diagnose.”

On the East Coast of the United States, medical oncologist Charu Aggarwal, MD, MPH, is also optimistic: “I think we’re at a place where we can manage.”

“I believe if there was going to be a new wave of COVID-19 cases we would be: better psychologically prepared and better organized,” said Dr. Aggarwal, assistant professor of medicine in the hematology-oncology division at the University of Pennsylvania, Philadelphia. “We already have experience with all of the tools, we have telemedicine available, we have screening protocols available, we have testing, we are already universally masking, everyone’s hand-washing, so I do think that means we would be okay.” 

Dr. Arnold agreed that “we are much better prepared than for the first wave, but … we have immense tasks in the area of patient management, the digitization of patient care, the clear allocation of resources when there is a second or third wave. In many areas of preparation, I believe, unfortunately, we are not as well positioned as we had actually hoped.” 

The first wave of COVID hit cancer services in the United Kingdom particularly hard: One modeling study suggested that delays in cancer referrals will lead to thousands of additional deaths and tens of thousands of life-years lost.

“Cancer services are working at near normal levels now, but they are still fragile and could be severely compromised again if the NHS [National Health Service] gets flooded by COVID patients,” said Dr. Sikora.

The second wave may be different. “Although the number of infections has increased, the hospitalizations have only risen a little. Let’s see what happens,” he said in an interview. Since then, however, infections have continued to rise, and there has been an increase in hospitalizations. New social distancing measures in the United Kingdom were put into place on Oct. 12, with the aim of protecting the NHS from overload.

Dr. Arrué describes it this way: “The reality is that the ‘second wave’ has left behind the initial grief and shock that both patients and health professionals experienced when faced with something that, until now, we had only seen in the movies.” The second wave has led to new restrictions – including a partial lockdown since the beginning of October.

Dr. Aggarwal says her department recently had a conference with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, about the impact of COVID-19 on oncology.

“I asked him what advice he’d give oncologists, and he said to go back to as much screening as you were doing previously as quickly as possible. That’s what must be relayed to our oncologists in the community – and also to primary care physicians – because they are often the ones who are ordering and championing the screening efforts.”

This article was originated by Aude Lecrubier, Medscape French edition, and developed by Zosia Chustecka, Medscape Oncology. With additional reporting by Kate Johnson, freelance medical journalist, Claudia Gottschling for Medscape Germany, Leoleli Schwartz for Medscape em português, Tim Locke for Medscape United Kingdom, and Carla Nieto Martínez, freelance medical journalist for Medscape Spanish edition. 

This article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article