Federica Santoro 0:08

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. This episode is part of the Uppsala Reports Long Reads series, where we select the most topical stories from our magazine, Uppsala Reports, and bring them to you in audio format. Our pick for today is Into the Infodemic: Countering COVID's medicine myths. The article was published online in December 2020 and will soon appear in print in issue 84 of the magazine. In a pandemic, it's not just the virus that goes viral. As COVID-19 spread around the world last year, so did waves of viral misinformation, which prompted some people to self-medicate with dire results. Marco Tuccori works as pharmacovigilance manager at the University Hospital of Pisa in Italy. In his article for Uppsala Reports, he explains how fighting the infodemic is a massive but necessary battle that the pharmacovigilance community cannot shy away from. After the read, I asked Marco a few questions about pandemic-related communications, so stay tuned till the end. But now let's dive into the article. Here's Into the Infodemic, written by Marco Tuccori and read by me, Federica Santoro, and my colleague Matthew Barwick. The word viral entered common language in recent years to indicate a piece of communication that, regardless of its format, quickly spread to a large number of people, generally by social media sharing. The 2020 COVID-19 pandemic has not only made us rediscover the original meaning of viral, but also elevated the concept of viral communication to what we would call an infodemic. The infodemic bears the pandemic's characteristics of speed and a huge number of people reached, but adds an amount of information of unprecedented magnitude. The implications and consequences of this infodemic have been many, probably some still undiscovered. Certainly, they have affected all sectors of human activities, and pharmacovigilance has not been spared. Indeed, a good percentage of the viral information has concerned the drugs and other potential treatments for the new disease, finding fertile ground in a frightened population, possibly influencing their behavior. Uncontrolled information on drugs has also reached opinion leaders, who have often amplified it in the most disparate directions, sometimes for their own political or economic interests. Some of the most serious consequences were observed in the first phase of the disease during the second quarter of 2020 when uncertainty and panic reached their peak. People had begun to look with hope at every treatment highlighted on the web, without necessarily understanding the scientific evidence supporting its use, and without distinguishing between preventive use in healthy subjects and treatment in sick ones. The rush to purchase products that promised a benefit was inevitable, seemingly often outside the control of prescribers, and with sometimes extreme consequences. The most emblematic case was that of chloroquine hydroxychloroquine. A much criticized study with many methodological limitations conducted in France on a small population had reported some benefit of these drugs for COVID-19 patients. In the United States, the products were promoted by social communicators and opinion leaders to such an extent that a healthy man, trying to protect himself from infection, died after ingesting a fish tank cleaning product that included chloroquine phosphate, among ingredients, on the label. Another broader consequence was a depletion of stocks, resulting in a shortage of drugs for patients who relied on it for conventional indications such as lupus and rheumatoid arthritis. In South America, one of the protagonists of the infodemic was ivermectin, a medication used for parasitic infections, easily available in pharmacies and commonly used for veterinary treatments. A potential efficacy for ivermectin had been postulated, but at concentrations that could only be reached in humans at the cost of severe neurological and liver toxicity. On the other side of the coin, the infodemic has also jeopardized the required use of drugs where concerns have been raised about a possible increased COVID-19 related risk. For example, in the case of certain antihypertensive drugs, some regulatory agencies felt the need to specifically inform and reassure patients and urge them not to suspend life-saving treatments without medical supervision. In these scenarios in which the infodemic panic could have negative effects on the appropriate use of drugs, pharmacovigilance organizations have had to work on various fronts to defend and possibly restore safer practices. The first challenge is precisely that of communication, aiming for capillary control and possibly mitigation of circulating information that may promote the inappropriate use of drugs, such as abuse, misuse and overdose without adequate evidence of benefit, or avoidance without adequate evidence of harm. In addition to this, regulatory authorities and pharmacovigilance centers have often had to create corrective communication, acting as an information reference point for the media and the population. To be successful, this type of communication strategy depends heavily on social media. In Italy, for example, the European country that was first surprised and struck hard by the pandemic, many pharmacovigilance centers have focused their communication particularly on Facebook, providing almost weekly updates, information and recommendations on potential drugs to treat COVID-19. The information they used was selected from reliable sources, such as regulatory agencies, or was otherwise based on available scientific evidence. Given the potential risks associated with self-medication, the main communication targets of many pharmacovigilance activities in the pandemic have been patients, with an emphasis on the reporting of adverse events. In this context, poison centers, perhaps underused under normal conditions for pharmacovigilance activities, represent an additional source of data to measure the behavior of the patients themselves. Poison control centers have been used in the past for active pharmacovigilance projects in several countries, proving to be an excellent observatory for the identification of medication errors. This has been even more evident during the pandemic. For example, in the United States, there has been an increase in access to poison centers for problems related to excessive use and misuse of detergents and disinfectants. As a result of this, several institutions have recommended caution in the use of these products to avoid exposure related to inappropriate uses. The most recent wave of the infodemic is focused on new vaccines. Our ability to quickly acquire herd immunity to viral information about vaccination programs will depend on effective communication, especially on issues of safety. The speed with which these vaccines were developed can easily be perceived by many people to be synonymous with superficiality and controls compared to a standard situation. This misunderstanding is fueled by some anti-vaccination and other generic disinformation sources in all media and must be fought not only with correct information, but also with transparent monitoring strategies of immunized subjects. Unfortunately, experience teaches us that it is very difficult to change dangerous behaviors based on deeply rooted beliefs or political affiliations by simply disseminating correct information. But the choice of communication strategy can make a difference. In general, the success of fake news seems to be based on communication that uses simple language, often with strong graphic or photographic elements, which influences people by leveraging frustration and stimulating resentment. This strategy aims to develop negative empathy towards pro-vaccine antagonists, often ascribing sinister or mercenary motives, and positive empathy towards the alleged victims of vaccination, who provide testimonials. But empathy can also be a powerful tool to counter misinformation and help communicate corrective information to the public. Testimonials from those harmed by bad information and dangerous behaviors can be used to help spread responsible information. The story of Olivia Dahl, daughter of writer Roel Dahl, author of Charlie and the Chocolate Factory and other novels, is a powerful example, often used to support measles vaccination. He recounted his daughter's death from measles-related complications in this way.

SPEAKER_00 10:14

As the illness took its usual course, I can remember reading to her often in bed and not feeling particularly alarmed about it. Then one morning, when she was well on the road to recovery, I was sitting on her bed showing her how to fashion little animals out of colored pipe cleaners, and when it came to her turn to make one herself, I noticed that her fingers and her mind were not working together, and she couldn't do anything. Are you feeling all right? I asked her. I feel all sleepy, she said. In an hour she was unconscious. In twelve hours she was dead. I was unable to do that for Olivia in nineteen sixty two, because in those days a reliable measles vaccine had not been discovered.

Federica Santoro 10:59

While countering misinformation, pharmacovigilance must also continue its primary role. In a pandemic situation where extraordinary speed is required, we still must ensure with our usual scientific rigor the safety of drugs used in COVID nineteen treatment and prevention. This includes monitoring patients receiving existing medicines usually used in other indications, as well as those receiving completely novel and sometimes complex treatments, such as antivirals, monoclonal antibodies, convalescent plasma, and last but not least, vaccines. It is possible that the communication strategies we use against this viral infodemic will fail, in whole or in part, and that many people will continue to be exposed to risky behaviors. But this should not make pharmacovigilance organizations and experts relax their efforts to provide responsible, correct information. For example, the simple promotion of adverse reaction reporting systems could be an effective approach to raise awareness of the safe use of drugs in the population. And any clear, correct information we produce can be leveraged by other health professionals in their communications. Whatever the scenario, it is certain that pharmacovigilance will continue to have an essential role in public pandemic-related communications. Hi Marco, and welcome to Drug Safety Matters. It's a pleasure to have you here with us today. Since you're based at a hospital, you work as pharmacovigilance manager at the University Hospital of Pisa in Italy, you must have plenty of first-hand experience of the problems that occur when people self-medicate or they engage in other kinds of harmful behaviors as a consequence of believing misinformation. Can you give me some of those examples that you've witnessed perhaps in your daily work at the hospital?

SPEAKER_02 13:11

Well, I must confess that during the pandemic we received not very much reports of such kind of issues. I remember that we received some reports of people with hypertension from the emergency department where they complain problem of hypertension because they suspended their ACE inhibitor. Because at that time the communication about this drug was that these drugs can have detrimental effects on COVID-19 infection. But what I can remember is that at that time we uh received several calls at the phone of people asking for information about hydroxychloroquine, because of course uh there were a lot of communication presenting this drug as a medical drug in uh in um in COVID-19. And I think that uh we were somehow lucky because uh people instead of acting impulsively preferred to call information center to receive some uh information about the drug they were thinking to take to prevent COVID-19. You know what I remarked in my article is that one of the problems was that people consider prevention in the same way of a treatment, and therefore this of course should have caused several problems in healthy people without any kind of symptoms at the time. But we make a check, of course, for more or less all the problems that you have described in the article, and we found that there was not an increase in the report of the drugs that were in the eye of the storm, and there was not an increase in the severity of such report. So I think that uh somehow people consider uh the problem with caution and did not act impulsively.

Federica Santoro 15:19

Now, in the article you mentioned how to use empathy rather than just contrary information to counteract misinformation. Can you give me some examples of that kind of empathic communication, especially related to the pandemic?

SPEAKER_02 15:36

Well, you know, empathy is uh incredibly powerful strategy to condition people by behavior, but unfortunately, it can be used in any direction. So it depends on the interest of the communicators. In the case of pandemic, uh, the best way to stimulate a positive behavior, for instance, supporting the use of protection tools or handwashing, social distancing, uh, maybe it was that of showing and presenting or describing whatever experiences from real life of people suffering due to the disease. This could be made in forms of graphic or in written form. An example could be picture of people forced in mechanical ventilation in intensive care units, or picture of healthcare professionals working in overcharging hospitals, or even stories told by people who lost relatives due to COVID-19, or stories by recovery people about their experience in intensive care units. But now we are facing a situation that I think it is quite harder to manage, which is that of the death of patients following vaccine administration. I think that people interested in producing detrimental effects on the attitude to vaccination are exploiting empathy with stories of persons with their relatives died a few days after vaccine administration, you know. But if I had to think to uh a strategy, an empathic strategy that can counter such kind of communication, I think that for instance we could show vaccinated elderly people that can embrace their relatives after months of quarantine.

Federica Santoro 17:19

And I'll ask you more about vaccines in a second. But first I was wondering: since you work as pharmacovigilance manager at a hospital, you must have scientific responsibilities but also administrative and communication responsibilities. Now, has the COVID-19 pandemic changed the balance of your work? And I'm thinking, has it especially called on you and your team to engage more in communication or to think more creatively, perhaps, about communication?

SPEAKER_02 17:52

Yes, uh pandemic changes uh a lot the balance of my work. You must consider that my hospital is uh hosting the pharmacovigilance center of the Tuscan region. And therefore, we need to address the communication not only to the hospital and to people working in the hospital or a chest in the hospital but to the entire population of the region, which is about 3,600,000 people. The health authority of the region created different task forces to prepare emergency plans. There was not an emergency plan because the pandemic was totally unexpected, and pharmacovigilance was involved in several of these plans. And these plans include, of course, communication plans, but also plans, for instance, for stimulating spontaneous reporting of adverse events following immunization to make this processes easier for users of healthcare facilities in the regions. And we had to rethink our strategy of communication, and this strategy has had to be extremely dynamic to face new situations every day. We can make again the example of vaccine and the AstraZeneca vaccine because of what happened very recently with the suspension of the vaccine, more or less by all the European regulatory authority. In particular, we have implemented a lot our communication using social media. So Facebook, Instagram, and LinkedIn. But I think that social media are likely the most effective way today to communicate something because of the possibility of achieving a large number of users with uh just one post. So I think that even regulatory authorities must exploit social media to achieve effective communication. I always thought that risk communication in Italy was somehow neglected on superficially considered, but I think also that uh with the current challenge something has changed or something will change in the near future. For instance, we need to implement the teaching of risk communication in uh in the course of medicine or in other related graduation courses to students. And I think that myself, I'm going to update my uh lessons plan for students attending my courses of pharmacovigilance in the next years.

Federica Santoro 20:37

That's really good to hear. Risk communication is probably the greatest challenge for pharmacovigilance professionals, and we've all come to realize that last year. Um, one final question before I let you go. Your article was written before any of the COVID-19 vaccines were rolled out, and so that's why you focused it mostly on COVID-19 therapies. What has changed since then? And you touched upon this a little bit in your previous answers, but could you tell me what keeps you awake at night now? What are the most pressing issues in pharmacovigilance communication nowadays?

SPEAKER_02 21:20

The problem of death following vaccination administration is the most relevant topic of communication at the moment. You know, in recent days almost all the European regulatory agencies, including Italy, Germany, France, Spain, decided to suspend the use of AstraZeneca vaccine for COVID-19 because of possible fatal events of clotting and thrombosis developed in a period that is at least temporally close to the vaccine administration. Well, in my opinion, this risk minimization strategy is a little exaggerated given the available information. However, what I have seen. In many newspapers, titles that can be summarized: as Patients Diet for Clotting Problems After Vaccine Administration, which can be easily read by people as patients died for clotting problems due to vaccine administration. It seems like the title of an horror movie. You know that this title is a high probability of becoming viral in social media and achieving a large number and reach large number of users. So I think that's uh in terms of communication and consequent behavior, there are two orders of outcomes that we can expect. The first is the uh the most obvious, no, many people who booked their vaccine injection decided to withdraw their booking. And this started when the first agency, the Danish one, announced that they have suspended the use of AstraZeneca vaccination. We are seeing here in my hospital that a lot of people have announced their decision of withdraw their booking for receiving the AstraZeneca vaccine. The second is a little trickier because I expected people vaccinated with this vaccine who think that taking an anticlockin drug or even an antiplatter drug, such as eparines or even warfarin or even other oral anticoagulants could prevent any thrombotic risk. So, in this way, if they decided to took spontaneously death drugs, they will expose themselves to an unnecessary risk of bleeding. So, in my opinion, this could be a problem. We should consider particularly in the next week that will require a further implementation of the communication strategy. In Italy, we have already faced a similar emergency in communication in 2014. After the withdrawal of a batch of an influenza vaccine, because of the rapport of three fatal cases, the consequence of such a decision was that many people refused any flu vaccine in that year in 2014, and probably in the years after. And we don't know whether this had consequences on the number of deaths due to influenza in that year. And this, despite at that time, the agency, after making the opportune investigation, declared that there were not a problem with that batch. So we are in a very similar situation. But we must consider that the public opinion is at the moment extremely more sensitive than in 2014. And we must uh also consider that uh apparently we have not learned the lesson from that uh case. We are into a pandemic with a thousand people dying every day for the disease, and we must reconsider our idea of benefit risk balance in the light of this situation, and I think when approaching the vaccine, that being not vaccinated is extremely more dangerous than being vaccinated.

Federica Santoro 25:36

Thank you, Marco. There's a lot of interesting points there that our listeners can think about. I thank you for your time, and I wish you and the other pharmacovigilance professionals around the world the best of luck in these extremely challenging, but also, may I say, intellectually stimulating times.

SPEAKER_02 25:55

Thank you for your interest in my work, and I think we need a lot of luck for the for the near future to handle the current situation. Thank you very much.

Federica Santoro 26:09

That's all for now. But we'll be back soon with more long reads as well as our usual conversations with medicine safety experts. In the meantime, check out the episode show notes or visit upsalareports.org to learn more about the infodemic. If you'd like stories like this one delivered straight to your inbox every month, sign up for our free newsletter at upsalareports.org slash subscribe. If you like our podcast, subscribe to it in your favorite player so you won't miss an episode. And while you're there, we'd love it if you could leave us a review so other listeners can find us. Any comments or suggestions for the show are welcome. Look for Uppsala Monitoring Center on Facebook, LinkedIn, or Twitter, and come talk to us there. For Drug Safety Matters, I'm Federica Santoro. I'd like to thank Marco Tuccori for the interview, Matthew Barwick for post-production support, and of course you for listening. Till next time.