(excerpted from a lecture given at the Drexel College of Medicine’s Clinical Research and Organization program)

The response to the Covid-19 pandemic has become so highly emotional and political for many people in the U.S. that even our most basic approach to public health is being challenged. In fact, the current environment has compelled me to feel the need to choose my words carefully. But it is not out a concern for political correctness.

Let me be clear. I think we should wear masks, practice physical distancing, avoid large gatherings and wash our hands often. As an aside, I don’t like the phrase social distancing and use physical distancing. Our political disputes are all too frequently creating social distancing among us – and not in healthy ways. 

Anyway, I think we should wear masks, practice physical distancing, avoid large gatherings and wash our hands often To me, it is just common sense. You cannot negotiate with a virus. And Covid-19 is not like the flu because we have no vaccines and almost nothing to treat the disease itself.

Sadly, these last few words ordinarily would not be anything special or extraordinary. But in this climate, these words could be construed as politically provocative.

So when contemplating this lecture, I was irritated/astonished/disconcerted/dismayed – call it what you may — to even realize that maybe I have to choose my words carefully if I wanted to create some teachable moments.

Fortunately, I had a conversation with a very close friend, who wondered why Anthony Fauci, the NIH Director of the Institute of Allergy and Infectious Diseases, has been so measured in the way he presents his thoughts and prescriptions.

Isn’t it obvious that we need to wear masks, wash our hands, avoid large crowds, and practice physical distancing?

After putting aside my own exasperation with the truth of my friend’s words. – I realized that public health officials are trained to deal with public health –and that means all of the public – not just those who agree with us.

And those in public health understand that we will not berate our way into convincing people to put on masks, wash their hands, avoid large crowds or practice physical distancing as satisfying as yelling and insulting may feel.

That strategy has not gotten us far with the anti-vaccine crowd and it is not getting us anywhere now.

But who could have predicted that such a simple measure as wearing a mask would provoke such outrage in some people?  We don’t often see this when other medical treatments often require more complicated, lengthy and painful things of people.

So the times speak to a need to talk in ways that continue discussions, not end them or create winners and losers or the need to score meaningless rhetorical points. We need a mixture of persistence, patience and good will.

The pandemic has shown us that our products and therapies will not always be well-received by everyone. Even if the stakes are life and death or serious illness.

The situation is more than a little frustrating but it calls for more exploration, not resignation….

 

SCIENCE STILL MATTERS

 

But as the federal government talks about a warp speed program for a vaccine, the manufacturers and policymakers will have a harder time in trying to take shortcuts on the science.

Why?

Science still matters in product development.

Because the public needs to have confidence that a vaccine or treatment will work. We’ve already run into confusion and angst over the unfounded assertions that prompted the off-label use of chloroquine and hydroxychloroquine.

And also remember, that the rest of the world is dealing with Covid-19. It will be difficult to indefinitely sustain a problematic product or course of action when the rest of the world is watching and reacting. Not only on a scientific basis, but also on decisions on how to share the vaccine when one is developed. And in yet other ways. For example the EU is limiting  U.S. citizens entry into member countries  because of the Covid rates in the U.S.

Despite all of this, we will get through Covid-19. But the danger – my concern- my fear — is that we will no longer feel the proper urgency to save lives to do it – at least in the short-term….

 

VACCINE SKEPTICS & RACIAL INEQUALITY

The nation as a whole is starting to accept that there has been systemic racism in the U.S. and that there have been health consequences that stem from these inequalities. People of color seem to have higher infection rates possibly because they are ones providing essential services and have not been able to stay at home. And do not have access to the same kinds of services as others.

People of color also have a sad history with organized medicine that goes beyond the horrors inflicted on the Tuskegee Airmen and being routinely denied medical treatment due to the color of their skins.

But there’s more to this that also goes to the prosperity of a community and how retailers feel about serving those communities.

A few years ago, I had to change doctors because the one I was seeing had retired. My new doctor learned that I taught at Drexel and so she asked me what I thought we needed to do about healthcare. I suspect she expected me to say something about the Affordable Care Act or something about changing regulations on research.

What I did tell her was this: If I could do only one thing, I would ensure that every community had access to fresh produce.

Initially, she was startled at my answer, but then understood quite clearly what I meant. Good health starts with good nutrition which means easy access to nutritious foods.  And Covid-19 is particularly dangerous to those who already have health problems. It is not a big leap to go from poor nutrition to to poor health….

 

NEW PRODUCTS EVEN FOR DENIERS

The virus also attacks those with respiratory problems – which could prompt new products to treat those types of conditions in the new world of Covid-19. So public health and population health are not divorced from our world of clinical trials – they help inform our next development moves.

And if a significant portion of the population are in denial about the virus or refuse to listen to medical advice, then the biomedical product companies can be expected to develop or at least examine the market for products that meet the health needs of that population. It is a cold hard truth that if enough people make poor decisions on a health issue or simply have bad luck, medical product makers will try to meet the need.

We do similar things now in dealing with opiate addiction and cigarette smoking.   

Not to be too harsh, but this is what may go for compassion in a free market system…

 

A CHOICE

We don’t see people often argue about getting a treatment for a specific disease or do any number of unpleasant things in getting treatment for cancer or even wear a mask when asked to in a hospital.

But we see people reject treatments as well… as not worth the cost of quality of life for the remaining time they have or out of concern of bankrupting their families or out of religious conviction or for any number of reasons too numerous to list.

The outcry – if there is one – is usually confined to family and friends.  Sometimes, however, such decisions do become incredibly public and political, most notably when the issues involve reproductive rights or the right to die.

But it is the collective nature of a pandemic’s effects that make the difference.

Our actions or inactions directly affect everyone else in the pandemic era. So the public health response and biomedical product develop process have the potential to be turned into political battles.

And so they have this year.

And in this election year, we are confronted with two distinct political choices on how to confront public health issues. The outcome will affect the choices we make in biomedical R&D.

 

A few words on “defunding” police departments…

It seems that I’m worried about something every day…Well, today it is how the discussion about “defunding” police departments will be taken out of context. So here is a short brief on some aspects of the debate over “defunding” police departments.
Many years ago, I had a client who asked me to do some research on creating an industry newsletter for law enforcement on police liability. Some of what I’m relating here is based on that research.
But before I begin, let’s be clear, institutional racism and discrimination in any area of our society are about how we raise and teach our children and how we interact with each other. It is about the expectations we have for each other in a civil society. When leaders lower the bar on respecting the dignity of others and when people are given tacit (or not so tacit) permission to engage in racism and discrimination, reform will be that much more difficult to attain and our lives will be poorer.
There will be those who actually believe the debate is about eliminating police departments (insert heavy sigh here) instead of curtailing the responsibilities heaped on police departments. There will be little that can be said to convince these individuals, who have no real interest in discussions and getting to a meaningful understanding of the concerns about police behavior.
However, for the vast majority of us, I’ve compiled partial lists of issues and organizations that will be part of the “defunding” debate to complement what I have posted earlier.
No discussion about police departments makes sense without a recognition of all the roles that police officers are called upon to play, such as resolving family disputes, moving homeless people into shelters and assisting those with mental and substance abuse issues.
Generally speaking, police officers are seen to have four major responsibilities:
** enforcing laws,
** preventing crimes,
** responding to emergencies, and
** providing support services.
It is no surprise that these broad categories often overlap.
Mistrust of the police already is prompting a renewed discussion of how police enforce laws and prevent crimes. But defunding efforts are not typically aimed at fundamentally altering those two responsibilities. No one has suggested that the nation no longer have a constabulary to enforce the law and make arrests.
Instead, in this context, the debate is typically about tactics (such as choke holds and the use of tear gas etc…). For example, most – if not all – police departments discourage high-speed chases that make for exciting TV shows and movies. The risk to the general population is very high.
Crime prevention is a murkier topic – unless one defines that strictly as foiling an attempt at crime. But that category often includes such activities at nighttime basketball to keep at-risk youths occupied and off the streets.
So, when talking about “defunding,“ I submit that a key question is under what circumstances should the threat of arrest be made? In other words, when should the police be called? When should the police play a secondary and more subtle and discrete role? Or no role at all?
If they are present in a support role or not present at all, will that limit abuse? Where should we reduce the responsibilities on police officers so we no longer have to fund those activities?
There are many many organizations to track in the defunding debate. I’ve listed only a handful of relevant categories to illustrate the breadth of the issues. A simple Internet search for state and local organizations and agencies will generate lists of links to the organizations of specific interest to you locally.
** Educational institutions at all levels,
** State and local public health departments, and
** State and local social service departments and organizations tending to:
* Homelessness
* Hunger
* Mental health issues
* Substance Abuse
We already know that any change will begin with the police themselves. So here are links to two unions, which represent the police. Change will be much easier to attain when the police themselves and their representatives acknowledge the need for change.

American Federation of State, County & Municipal Employees, (AFSCME), which includes police unions

https://www.afscme.org.

The International Union of Police Associations

https://iupa.org/

I grow increasingly concerned that after the protests subside over the horrific death of George Floyd, the energy will be dissipated. I’ve spent much of my career as a journalist looking at the structure of governance and I offer these initial thoughts on where to look and continue to fight for change above and beyond the Black Lives Matter, the ACLU and others.

These groups are important, but they also recognize that much of their energies have to be directed to these organizations as well.

While there may be an effort to push federal legislation, much of the real work will be done on the state and local levels as well as on the individual department level.

That would include training and accreditation as well as insurance to underwrite the risks posed by law enforcement activities.

So I’ve compiled a preliminary list of organizations we should watch or interact with as the nation moves toward a better tomorrow. Please note that this list goes beyond watching Law & Order, Chicago PD and all of the CSIs.

Some of organizations often have model laws and policies and educational tools that are used by police departments and their civilian management.Some of these entities have issued statements on the ongoing protests over police brutality; others have not. But I’m not ready to read anything into that yet.

A particularly good resource is the National Conference of State Legislatures, which tracks legislative action in the states.  

https://www.ncsl.org/

The National Conference of Mayors:

https://www.usmayors.org/

National League of Cities:

https://www.nlc.org/

The National Association of Counties:

https://www.naco.org/

The National Governors Association:

https://www.nga.org/

The International Association of Police Chiefs:

https://www.theiacp.org/

Other places to check for meaningful change will be with the liability insurers that underwrite the risk for police departments, law enforcement officers and local and state governments. Insurers are often the hidden regulators that force organizations to improve operations, training and education. The Atlantic ran an interesting article in June 2017, illustrating the power insurers can wield. (How Insurance Companies Can Force Bad Cops Off the Job)

(https://bit.ly/2BxJ5Bf)

To end this initial list, start examining the accrediting bodies for law enforcement. One of the largest is the Commission on Accreditation for Law Enforcement Agencies, Inc.

https://www.calea.org/

This initial list of “industry” organizations also helps show how complicated this reform process will be.
This essay explains some major issues involved in drug research and development as they relate to the COVID-19 pandemic. I have lectured on drug development at a medical school for almost 15 years and I want to contribute some basic information that may prove helpful for others.
Note that these are my own thoughts and not attributable to any organization or institution. I simply want to draw your attention to some basic facts. Facts matter because we cannot negotiate with a virus.
I will be as concise as possible to foster understanding and gloss over the finer points of the debates in this area. As events unfold, I will add to this discussion.
One of the most urgent challenges is to fight the temptation to recommend or approve pharmaceuticals and medical tests before they have undergone proper evaluations to ensure that they are safe and effective.
For medical tests, which are regulated as medical devices, that means that they are safe for humans to undergo and that they consistently provide accurate results. A test that provides too many false negative or false positives is not an effective test and can cause great patient harm.
A key point here is that the marketplace is not a good environment in which to test such products. People are injured or die from products that have not been properly vetted. So before products are allowed to compete in the marketplace, they must prove their worth first.
FDA & POLITICS
FDA is not inherently a political entity. It was established to ensure that biomedical product manufacturers marketed products that were safe for human use and were effective in treating, testing or assessing patients.
However, the products that FDA regulates are often highly politicized and that is where problems arise. Up until the COVID-19 pandemic, the most obvious examples of highly politicized products involved stem cells and birth control products. These products continue to be caught up in our culture wars.

Unlike the products fought over in the culture wars, the war against COVID-19 has been politicized over the issues of data and patience. There are powerful pressures to find COVID-19 treatments because they would lay a firm basis for reopening the economy. If we can treat the disease then it becomes more like other diseases that we suffer from now.

 

FDA is being drawn into the political arena as the Trump Administration wants to show progress in dealing with COVID-19. The pressure to act quickly builds with each passing day.
FDA’s primary job is to ensure that manufacturers do not make unjustified health claims about their products. At the same time, FDA is also acutely aware that unnecessary delays in allowing products into the market cause harm as well.
Consequently, the process through which FDA approves products for the market is more than a bureaucratic exercise. The way the agency approves a product is by requiring clinical trials for new products or for new health claims for existing products.
If a manufacturer wants to put a health claim on a product label or in its marketing material and sell it, the company first has to prove that claim to FDA’s satisfaction.
THE CLINICAL TRIAL STRUCTURE
The clinical trial structure is the way to prove that products are safe and effective to FDA.
FDA generally describes the clinical trial process in this way:
  • PHASE I TRIALS: Researchers test a drug in a small group of human subjects for the first time. Researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
  • PHASE II TRIALS: The drug is given to a larger group of human subjects to test its effectiveness and to further evaluate its safety.
  • PHASE III TRIALS: The drug is given to large groups of human subjects. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect data that will allow the drug to be used safely.
  • PHASE IV TRIALS: Post-marketing studies are conducted after FDA approves the product to obtain additional information including the risks, benefits, and best use.
Medical tests and diagnostics tools go through a similar regimen as drugs to evaluate safety and efficacy.
At this time in the pandemic, we are most concerned about Phase II and Phase III trials.
Existing products are also of intense interest because they have at least been proven to be relatively safe for human consumption. The important thing to remember, though, is that existing products are not necessarily safe for all patients. These products were designed and approved to treat people with specific conditions or symptoms and not for the general population.
News now has broken that a clinical trial demonstrated that remdesivir may curb the effects of COVID-19. That is indeed good news and a movement in the right direction. However, the results, while “clear cut,” are still tentative.
Nevertheless, FDA is expected to approve the product on an “emergency use” basis. But many experts say that the results are only preliminary.
And even if remdesivir proves to be an effective treatment, it is only one limited tool and will not be enough to start relaxing pandemic precautions, such as physical distancing and mask wearing in the near term.
The great fear is that this bit of good news will weaken the public’s patience with these precautions and prolong the pandemic by forcing policymakers to prematurely relax these safety and health protocols.
OFF-LABEL USE
A significant controversy surrounds actions by President Trump in touting Hydroxychloroquine and Chloroquine as potential treatments for COVID-19. This was dangerous. These two products were designed and proven to treat lupus, rheumatoid arthritis and malaria. They were not proven to treat COVID-19.
Such actions present significant dangers because FDA does not regulate doctors. It only regulates biomedical product manufacturers. This is important, but it requires a little explanation.
Doctors are free to prescribe any drug or medical device based on their experience and knowledge (and their fears of malpractice suits). But often, they prescribe products at the insistence of their patients, which is one reason why drug companies spend so much money on direct-to-consumer advertising. And it is one reason why ill-considered statements from politicians are dangerous to public health.
When doctors prescribe drugs for purposes not included on the FDA-approved label, that use is called “off-label” use. This is not uncommon in the practice of healthcare, but it is still a gray area in the world of pharmaceutical R&D and sales.
In normal times, this kind of practice often raises concerns among consumer groups and some regulators. The worry is that drug companies may try to convince doctors to prescribe their products for conditions or symptoms not on the label. In other words, off-label use can be abused by enabling drug companies to avoid spending the time and money to conduct proper testing for the new use of the drug.
This can turn patients into de facto research subjects.
When the leader of the federal government recommends the off-label use of a product without any evidence of its effectiveness, it drives up the demand for that product. That was the case with Hydroxychloroquine and Chloroquine. Patients fearing COVID-19 demanded prescriptions for these products.
That meant that patients for whom Hydroxychloroquine and Chloroquine were designed were in danger of not having access to those drugs because of that demand for unproven uses for COVID-19.
The anxiety caused by the fear of a shortage was deep and real. Worse, it potentially made sufferers of lupus, rheumatoid arthritis and malaria even more vulnerable to COVID-19.
In other words, President Trump’s ill-advised trumpeting of Hydroxychloroquine and Chloroquine put patients with lupus, rheumatoid arthritis and malaria at risk by threatening their access to those drugs.
To put this into context:
  • 1.5 million Americans have lupus.
  • About 1.3 million Americans have rheumatoid arthritis.
  • More than 225 million people around the world have malaria, but fortunately few Americans suffer from this disease.