Here We Go Again – Monkeypox Communications Challenges

Source: CDC

In February 2020 I published a blog posting – Emerging Pathogens, Communications – that encapsulated my observations and learnings from my years work in the early years of the HIV/AIDS pandemic in the early 1980s. As we sit, possibly, on the cusp of another large scale medical challenge with monkeypox, it seemed like a good idea to revisit the topic. When there is a new and scary thing we are facing, medically speaking, there are some truisms regarding the communications environment that can inform strategic thinking about how we talk about it.

  1. Facts are low, speculation is high – And nature hates a vacuum and there will be many who are willing to fill the void with misinformation. People want facts, and the fact is, facts are in short supply.
  2. Numbers don’t mean a lot – First of all, they change quickly – and are changing very quickly with monkeypox. In addition, there is often a lack of accurate reporting for many reasons.
  3. Points of reference will change – What we know, and what we don’t know, will change over time as we get more experience and gain wider understanding. That might seem like a good thing, but in fact, changing stories undermine credibility.
  4. Fraud potential is high – There are people who will take advantage of the situation and exploit it for political and/or financial gain. That, too, impacts credibility and can confuse people.
  5. Policy is likely to be ham-handed – Policies may be developed quickly and without adequate information and be based on emotion and bias more than facts. This is another factor that strains credibility.

Monkeypox is not COVID, and COVID was not AIDS. They each present distinct challenges and evoke particular fears and concerns. There are big differences between the three. But they are all viruses. And when it comes to communications challenges there are many commonalities.

First and foremost, in the absence of facts, fear can drive actions. And when a pathogen is newly emerging, facts are greatly outnumbered by questions. The degree to which companies, educators, businesses and service providers may want to prepare to deal with those challenges may depend on where they are, who their stakeholders are, and how big or small they are. At this stage though, better to consider the challenges that may lay before you know, before they present themselves.

Source: CDC

Analysis

It may be that monkeypox is contained early if we are lucky. There are reported signs that transmission may be slowing in the U.K. and the trend in the graph above appears to show some deceleration. That said, the numbers have increased quickly on an extremely steep curve. That means there is an increasing amount of virus out there. The virus has mainly spread among men who have sex with men and transmission is being attributed to skin contact. But the higher the numbers go the greater potential there is for more lateral spread. A presumptive pediatric case was reported last week in California. It is also a virus that can move between people and animals.

Containment depends on systems that are able to screen, test, treat, and prevent (both by means of avoiding circumstances that can enhance transmission and by vaccination). To that end, many things are not in our favor. An extremely splintered approach at federal, state and local levels impacts the coordination of a public health response. We have COVID fatigue in the extreme. And in terms of tools, we do not have a means for screening, meaning we do not know who is infected before they exhibit symptoms which may take several days; the testing situation is complicated because there is no quick, at-home testing like there is for COVID and may be best applied when there are lesions. But people may have other symptoms such as headache, chills, muscle aches, swollen lymph nodes and exhaustion. The only FDA-approved drug to treat is approved for smallpox, but no Monkeypox and has been difficult to access. In terms of prevention, while a vaccine has been developed, supply is very short and it, too, has been hard to get.

Additional challenges include the fact that the course of illness runs two to four weeks. If a person must self-isolate for that length of time it is not only difficult, but there may be collateral consequences. With men who have sex with men comprising the overwhelming majority of cases, a diagnosis is the equivalent of coming out. For many gay men that is not a problem. For many others, who may have wives and children, it can be a very large one, facing a situation that may have both personal and professional peril.

At the present time, there are some states which are reporting higher numbers than others. If the numbers do continue to climb, then a larger number of geographies will be impacted and most likely a wider circle of people, raising the chances that large employers, those in specific sectors, may face communications challenges sooner rather than later such as:

  • Travel and hospitality
  • Schools and universities
  • Hospitals
  • Institutional settings such as daycare centers, rehab and nursing homes (a case of a daycare workers was reported in Illinois last week)

What to Do

Every business, service or place of public accommodation is different. There is no one-size-fits-all approach to preparation. One must consider the size of the enterprise, the stakeholders and the level of physical contact and interaction with surfaces. That said, there are echos from both AIDS and COVID that shed light into how people may react to the emergence of another communicable condition. A few things to consider:

  • Review policies and assess what may need to be changed or amended; this is not just COVID return-to-work policies, but discrimination policies as well. Re-think many of the things you have had to communicate about a virus transmitted by air, and re-fashion to think about surfaces. Monkeypox will present distinct challenges.
  • Consider the questions and issues you may face. Can we catch monkeypox using the toilet? Trying on clothes? Do I have to sit next to the gay man? My co-worker says it is eczema, I’m afraid it is Monkeypox. Depending on your business, your clientele, there are different sets of questions that may arise for different settings. Think about what they might be and to what degree you are the one to have to provide the answers.
  • Assess the triggers for potential fear and conflict between employees, customers and users of any service.
  • Communicating in an environment where what we know changes, and what was certain yesterday may be uncertain tomorrow is always a strain on credibility. Therefore consider integrating reminders to that effect in your messaging. What we know now is….
  • Gather reliable resources – the obvious ones such as CDC, FDA, and Departments of Health at the state and local levels, but also consider credible grassroots organizations, particularly ones that may resonate with stakeholders, particularly those dealing with gay-related health issues and key medical societies such as the American Society for Microbiology and others.

Many people think that preparation during such a nascent phase of the outbreak is over-reacting. I hope they are right. But having lived through AIDS and COVID, and seen early numbers quickly spell a different story over a very short period of time, one may be well-served to think it through now.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement.

But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year. By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. And since 2014 the Office of Prescription Drug Promotion (OPDP) has broken double digits only 3 times, producing only 6 letters in both 2020 an 2021. So far this year, we are at 4, which is a pretty good clip these days.

While it is difficult to discern trends with such a small number, an examination of recent warning and untitled letters reveals some possible shifts in priorities and emphasis that may be worth noting. That is particularly true since we have a new FDA Commissioner, a new head of the Center for Drug Evaluation and Research (CDER), and a new head of OPDP.

The 4 letters issued this calendar year:

  • Involved 3 Untitled Letters and 1 Warning Letter – a profile not out of proportion given that about 33 percent of letters issued since 2004 have been Warning Letters. One of the letters came to attention of FDA reviewers through the Bad Ad Program.
  • These 4 letters related to 5 different communications vehicles, 4 of which involved digital forms of communications – 2 were videos, 1 was a web page and 1 was an Instagram posting, one of the rare letters involving a social media platform. If you would look back to 2008, when digital and social media were in ascendancy by pharmaceutical companies, and compared enforcement involving traditional means of communications to those on digital platforms, letters from OPDP more commonly involve traditional means of communications (brochures, DTC print ads, etc) over digital (web pages, social media). While these most recent letters represent a small sampling, the fact that digital is over-indexed here potentially signals a heightened scrutiny involving digital platforms.
  • It should also be noted that one of the videos involved an oral statement made by the CEO of a company which was posted to a third-party site. The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. This perhaps emphasizes the role of media/message training prior to public-facing statement (at all stages of development).
  • The single letter involving a traditional communications platform was a printed information sheet directed to physicians.
  • Violations this year so far were 9 and included risk presentation deficits (3 letters) Superiority Claims and Unsubstantiated Claims (2 each) and Promotion of an Unapproved Drug (1).
  • Some of the triggers included
    • The use of studies in relation to a claim where the studies were unrelated and conducted in different patients for different lengths of time and were limited in design and analytic strategy;
    • Risk information that was presented in small bring, out of balance to the claims presentation as well as another risk presentation that offered risk in a fast-scrolling video that was out of sync with the benefits information;
    • A claim related to efficacy that did not more narrowly define the intended population as reflected in the label

When you view enforcement activity through a broader lens to get more examples to analyze, a few things stand out. Most notably, while promotion of an unapproved drug is a relatively rare violation, comprising only 2 percent of all the letters issued since 2004, it is 13 percent of all letters issued since 2016. Correspondingly, the instances of promotion of an unapproved use has diminished and was last named as a violation in 2019.

Finally, one characteristic of the regulatory action letters issued by FDA’s OPDP over the past several years is that they have principally involved smaller, lesser-known companies. It was very rare to see a company in the top 25 companies cited for violations. But this year and last year we saw Lilly receive two letters, Bausch receive one, and Amgen receive one. It may be an anomaly or it may signal a shift. For any trends to become apparent, there will need to be more enforcement actions. And for that, we must wait.

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New Approvals in 2022

We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhance the ability to bring more new treatments from test tube to medicine chest more quickly. Most notably in 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, bring to bear among other things, breakthrough therapy designation. Since that time, there has been a healthy output of new treatments.

But recently in the larger environment, there have been several factors that may have inhibited the flow of the medicine pipeline. The most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials. And then there is the fact that a number of clinical trials were being conducted either in Russian or in Ukraine prior to the outbreak of the war. On top of that, COVID-19, while representing a good deal of medical progress, also represents a tremendous diversion of resources in time, money and effort that might have been otherwise utilized. Finally, COVID also impacted FDA’s ability to manage the regulatory process itself. Advisory committee meetings have been far fewer and observationally speaking, FDA seems to be extending PDUFA dates quite regularly.

So how are we doing? There are a few things to look at.

  1. New Molecular Entity Approvals – The most obvious is to see how we are doing on new molecular approvals – those approvals representing entirely new treatments. Looking at past years and where we were at the mid-year point and where we ended up each year, can give us some insight into this year. The news is not so hot. By the end of June this year, FDA had approved only 16 novel drugs. By this time last year, there were 27. Below is a chart that compares year by year the rate of novel approvals as of the end of April and by the end of year.

This is not to say that the balance of the year might not make up for the slow first half. by mid-year 2019, there were only 13 approvals of new entities but the year netted out with a respectable 48. It all depends on what’s in the pipelineSo let’s look at PDUFA dates.

2. PDUFA Dates– PDUFA dates are proprietary and FDA does not publish a list of upcoming dates. Still, one can compile a list by capturing public announcements of new drug or biologic applications with FDA, many of which mention the specific PDUFA date and many that allow a guess based on counting from the date of a press release. Subtracting out applications for supplemental applications, there do not appear to be an overwhelming number of upcoming dates, which might undermine any recovery in the second half of the year to a more robust number of approvals of new molecular entities.

3. AdComms – Finally, as noted in a prior posting, the number of advisory committee meetings that FDA has been holding has diminished considerably overall. That means that the agency is utilizing outside counsel less frequently, perhaps due in some part to the advent of breakthrough therapy designations which means that the agency is having a higher level of interaction with drug sponsors that may negate the need for an AdComm. But one could also surmise that AdComms are reserved for circumstances where FDA wants outside counsel because an investigative compound is exploring new territory. In any case, the only recent advisory committee was one of the Cellular, Tissue, and Gene Therapy Advisory Committee which by its nature, is likely to be in regard to a new molecular entity.

In short, the outlook for output this year does not appear at this juncture to be promising. But there are many moving parts and when and if they do move, it can change the picture considerably. Certainly there have been years past where at mid-year, there was not a robust output, but which ended up much improved over the final half of the year.

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Enforcement Update: OPDP Issues Untitled Letter

We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, were Untitled Letters.

As noted in past updates, FDA’s OPDP enforcement letters have dropped off considerably over the years. In fact, over the past two years, the office issued only a total of 6 letters which means 2022 is going at a heightened clip. Of course, if OPDP only issues two more actions for this year, it would be on par with the recent track record – and sometimes several weeks can go by before OPDP issues a letter.

I like to take an approach to examine both the historical context and the substance of each individual letter.

The Letter. The recipient of the letter was Bausch Health Companies and it was in regard to two different communications vehicles – one a “DTC video” that appeared on Lifetime TV’s The Balancing Act – and the other the efficacy webpage of the healthcare professional website. The medicine that was the subject of these communications was DUOBRII (halobetasol propionate and tazarotene) a topical lotion indicated for the treatment of plaque psoriasis in adults. The risk profile of this medicine includes contraindication in pregnancy as well as risk of sunburn among other stated risks.

Taking the video first, there were a couple of things. First was the most common violation cited in OPDP letters – the presentation of risk information. The agency stated that material facts about the risks were not properly conveyed with particular regard to advising women about the risks during pregnancy and noted that the package insert advises a pregnancy test within 2 weeks prior to therapy initiation and advises on the use of contraception during treatment. The video portrayed a women of child bearing age – with two children – making the statement that she used the product during a flare up, implying it can be used any time. FDA did acknowledge the presence of information regarding fetal risk is present in the video, but indicated that the lack of specific reference to the need for testing and use of birth control were material. In addition, the patient in the video is depicted out of doors with exposed shoulders and arms, but did not mention the photosensitivity and risk of sunburn in the video. Finally on the issue of balance, FDA noted that the additional risks were addressed in small text at the bottom of the screen while benefits were being conveyed verbally by a narrator.

The other issue for the video was making an unsubstantiated claim regarding efficacy and an implication of superiority. The video stated that the medicine was the “first and only” topical combining two active ingredients, while FDA asserted that there was at least one other such combination. In addition, the patient depicted said that she had tried other creams that did not work for her. FDA said clinical superiority had not been established and that the statement implied that the medicine would be effective in patients who failed to respond to other treatments. While it may be accurate for this patient in particular, the agency said it could not be broadly applied to all patients.

When it came to the webpage, FDA took issue with language that made the claim of “superior efficacy” to mono therapies based on evidence that was characterized by the agency as a post hoc analysis of a single phase 2 trial not designed to support this type of conclusion.

The Context. It is important to look at context to see if there are any emerging patterns related to enforcement with respect to treatment categories, companies or communications vehicles. There are a couple of things of note. First OPDP enforcement over the past few years has not only diminished, but the actions have generally involved smaller, lesser well-known companies. However of the 11 letters (both Warning and Untitled) sent since 2021 began, Some larger, established companies have been included – such as Amgen and Lilly (which received 2 letters). Also of note, the treatment of pain, in particular migraine, was the subject of 3 of these 11 letters. But perhaps most noteworthy is the fact that the most common communications vehicle that was the target of enforcement were DTC videos which were the subject of 5 of the 11 letters.

Finally, it is noteworthy perhaps that OPDP acquired new leadership last year. That may mean an emerging difference in the way the office engages in enforcement.

Until next time.

Image by Goh Rhy Yan at Unsplash

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New Landscape for the Old Pandemic

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in motion as well. It is a fundamental re-shifting of the landscape. And there are consequences.

First, government funding supporting access to vaccination and treatment for COVID has run out and so far, is not replenished. The government established program to fund access for the uninsured has stopped accepting reimbursement claims for treatment and will stop shortly for vaccines (on April 5). For the insured and affluent, not much of a problem. For those without, it can become a major roadblock. And if you need therapeutics, the same problem, but with harsher consequences, especially once the federally purchased stockpiles of therapeutics and vaccines are gone.

Second, next week an FDA Advisory Committee had scheduled a meeting for April 6 (the day after the government program will stop accepting claims for vaccines) to consider whether or not to authorize use of two of the COVID-19 vaccines as a “second booster” or actually a fourth shot, either for people over 50 years or for everyone. Then on March 29, FDA issued an authorization for use prior to the meeting of the advisory committee, quickly followed by a supporting update for providers to permit access from CDC. A fourth shot will likely be authorized by CDC, though access may be different than in the past, especially after the government stockpile recedes.

Third, the BA.2 sub variant 0f Omicron is poised to cause an increase in U.S. caseloads as it has in other parts of the world, thought it is not certain when. According to the Centers for Disease Control (CDC) it is now the dominant strain. After weeks of falling caseloads, some areas like New York City and New York State have seen the rates per 100,000 start to rise again and the 14-day change in cases has risen 92 and 78 percent, respectively as of yesterday, and have been increasing for the past several days. With the fourth booster in hand, those most vulnerable might opt to take it now (while there is stockpile) only to see it wane if the BA.2 wave in the U.S. does not happen until later in the year.

Fourth, the rise in availability of home testing is likely masking (pun intended) the actual numbers. Whole families may be find they are feeling unwell, testing and finding they are sick, but never getting sick enough to get medical attention. So they are completely under the radar when it comes to the numbers that we are counting and upon which we are basing policy decisions, like mask requirements.

Fifth, the masks are dropping. Attending a theatre performance this weekend I was double bagged – a KN95 underneath and a second (more fashionable) cloth mask over it. But I was in the minority by far. The lowering of mask requirements and inclinations may spur the emergence of the sub variant, or future variants.

Sixth, speaking of new variants, in places around the globe where there large numbers of people are being infected there is a potential fro the development of new variants.

In short, we are being dealt a new hand. A more spreadable virus is among us just as our vigilance is waning. More vaccine doses are authorized, but access is narrowed. Cases are increasing while mortality – a lagging indicator – has dropped. And perhaps most important, we are not assuring widespread access to vaccines and treatments to the most vulnerable, we are not accurately counting, and we are not taking precautions. From a policy perspective, perhaps we needed a new hand, but one thing remains – in the face of on-going infection, access to vaccines and therapeutics remains essential. While we are looking at a new landscape, we are also facing certain obstacles.

Photo by Casey Horner on Unsplash

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