An inviting beach in Nassau, Bahamas.
Dr. Conville Brown, a cardiologist-researcher in The Bahamas, is at the helm of a fascinating worldwide project: He's leading a movement to help accelerate innovation by providing scientists and patients from around the globe with a legal, cost-effective, and ethically rigorous place to conduct medical research, as well as to offer commercial therapies that are already approved in some jurisdictions, but not others. He recently spoke with Editor-In-Chief Kira Peikoff about The Bahamas' emerging ascendance in the scientific world. This interview has been edited and condensed for brevity.
"You don't want to take shortcuts from the perspective of not giving proper due diligence to the process, but you also don't want it to be overwhelmed with red tape."
Tell me about the work you do in the Bahamas – what is the research focus?
We have a couple research opportunities here. Several years ago, we established the Partners Clinical Research Centre, the idea being that we can partner with different people in different territories in the world, including the United States, and be able to perform ethical research as would be defined and adjudicated by an institutional review board and a properly constituted ethics committee. We do all of this with FDA rigor, but in a non-FDA jurisdiction.
By doing this, we want to look for the science behind the research, and want to know that there is a sound clinical hypothesis that's going to be tested. We also want to know that the safety of the human subjects is assured as much as possible, and of course, assess the efficacy of that which you're testing. We want to do this in the same manner as the FDA, except in a more accelerated and probably less bureaucratic manner. You don't want to take shortcuts from the perspective of not giving proper due diligence to the process, but you also don't want it to be overwhelmed with red tape, so that what could be 3 months takes 3 years. A jet ski turns around a lot faster than the Queen Mary.
Why do you think the clinical research process in other countries like the U.S. has become burdened with red tape?
The litigious nature of society is a contributing factor. If people are negligent, they deserve to be sued. Unfortunately, all too often, some things get taken too far, and sometimes, the pendulum swings too far in the wrong direction and then it's counterproductive, so the whole process then becomes so very heavily regulated and financially burdensome. A lot of American companies have gone outside the country to get their clinical trials and/or device testing done because it's too phenomenally expensive and time-consuming. We seek to make sure the same degree of diligence is exercised but in a lesser time frame, and of course, at a much lower cost.
The other aspect, of course, is that there are certain opportunities where we have major jurisdictions, as in Europe, that have determined that a therapy or device is safe. Those services and devices we can utilize in the Bahamas--not as a clinical research tool, but as a therapy, which of course, the United States is not able to do without FDA approval. That could easily take another five years. So there is an opportunity for us in that window to make available such therapies and devices to the North American community. I like to call this "Advanced Medical Tourism" or "Advanced TransNational Medical Care." Instead of somebody flying nine hours to Europe, they can also now fly to the Bahamas, as little as half an hour away, and as long as we are satisfied that the science is sound and the approvals are in place from a senior jurisdiction, then we can legally serve any patient that is eligible for that particular therapy.
Dr. Conville Brown
(Courtesy)
Are you seeing an influx of patients for that kind of medical tourism?
The numbers are increasing. The stem cell legislation has now been in place for two to three years, so we have a number of entities including some large international companies coming to the shores of the Bahamas to provide some therapies here, and others for research. The vast majority of our clientele are from abroad, particularly the U.S. We fully plan to increase the traffic flow to the Bahamas for medical tourism, or preferably, TransNational Medical Care, Advanced and Conventional.
How do patients find out about available therapies and trials happening there?
Advertising in the international arena for something that is perfectly legal within the confines of Bahamas is par for the course. But the marketing efforts have not been that heavy while all the processes and procedures are being fine-tuned and the various entities are set up to handle more than 100 people at a time.
"We were able to accelerate those programs, and do it a lot less expensively than can be done in continental countries, but just as well."
What kind of research is being done by companies who have come to the Bahamas?
We've been involved in first-in-man procedures for neuromodulation of the cardiovascular system, where we inserted a device into the blood vessels and stimulated the autonomic nervous system with a view to controlling patients' blood pressure and heart rate in conditions such as congestive heart failure. We have also looked at injectable glucose sensors, to continually monitor the blood glucose, and via a chip, can send the blood glucose measurement back to the patient's cell phone. So the patient looks at his phone for his blood sugar. That was phenomenally exciting, the clinical trial was very positive, and the company is now developing a final prototype to commercialize the product. We were able to accelerate those programs, and do it a lot less expensively than can be done in continental countries, but just as well. The Bahamas has also crafted legislation specifically for regenerative medicine and stem cell research, so that becomes an additional major attraction.
Do you ever find that there is skepticism around going to the Caribbean to do science?
When it comes to clinical research and new medical devices, one might be skeptical about the level of medical/scientific expertise that is resident here. We're here to show that we do in fact have that expertise resident within The Partners Clinical Research Centre, within The Partners Stem Cell Centre, and we have formed our partnerships accordingly so that when prudent and necessary, we bring in additional expertise from the very territories that are seeking to accelerate.
Have you seen a trend toward increasing interest from researchers around the world?
Absolutely. One company, for example, is interested not only in the clinical side, but also the preclinical side--where you can have animal lab experiments done in the Bahamas, and being able to bridge that more readily with the clinical side. That presents a major opportunity for parties involved because again, the financial savings are exponential without compromising standards.
"A person who is 75 and frail, he doesn't want to wait to see if he will make it to 80 to benefit from the agent if it's approved in five years. Instead he can come to our center."
Where are some of these researchers from?
The United States, the Czech Republic, Russia, Canada, and South America. I expect significantly more interest once we promote the idea of European products having a welcome niche in the Bahamas, because we accept federal approvals from the U.S., Canada, and the European Union.
What do you think will be the first medical breakthrough to come out of research there?
One of the biggest killers in the world is heart disease, and we have the opportunity to implement a number of cardiac protocols utilizing stem cell therapy, particularly for those with no options. We just completed a state-of-the art medical center that we fashioned after the University of Miami that is getting ready for prime time. The sky will be the limit for the cardiac patient with respect to stem cell medicine.
Second, we are extremely pleased to be involved with a company called Longeveron, which is looking at how one might age better, and age more slowly, particularly with the administration of young blood and mesenchymal stem cells to frail, elderly candidates. Healthy young men have their mesenchymal stem cells harvested, expanded, and then administered to frail, elderly individuals with a view to improving their Frailty Index and functionality (feeling younger). There is a lot of interest in this arena, as one could imagine.
And herein lies the classical scenario for the Bahamas: Longeveron is now recruiting patients for its phase IIB double blind, placebo-controlled clinical trial at multiple sites across the U.S., which will add some two to three years to its data collection. Originally this work was done with NIH support at the University of Miami's Interdisciplinary Stem Cell Institute by Dr. Joshua Hare, and published in the Journal of Gerontology. So now, during the ongoing and expanded clinical trial, with those positive signals, we are able to have a commercially available clinical registry in the Bahamas. This has been approved by the ethics committee here, which is comprised of international luminaries in regenerative medicine. Longeveron will also be conducting an additional randomized clinical trial arm of same at our Centre in The Bahamas, The Partners Stem Cell Centre.
Can you clarify what you mean by "registry"?
In other words, you still have to fit the eligibility criteria to receive the active agent, but the difference is that in a placebo-controlled double-blind clinical trial, the physician/researcher and the patient don't know if they are getting the active agent or placebo. In the registry, there is no placebo, and you know you're getting the active agent, what we call "open label." You're participating because of the previous information on efficacy and safety.
A person who is 75 and frail, he doesn't want to wait to see if he will make it to 80 to benefit from the agent if it's approved in five years. Instead he can come to our center, one of the designated centers, and as long as he meets the inclusion criteria, may participate in said registry. The additional data from our patients can bolster the numbers in the clinical trial, which can contribute to the FDA approval process. One can see how this could accelerate the process of discovery and acceptance, as well as prove if the agent was not as good as it was made out to be. It goes both ways.
"We would love to be known as a place that facilitates the acceleration of ethical science and ethical therapies, and therefore brings global relief to those in need."
Do you think one day the Bahamas will be more well-known for its science than its beaches?
I doubt that. What I would like to say is that the Bahamas would love to always be known for its beautiful beaches, but we would also like to be known for diversity and innovation. Apart from all that beauty, we can still play a welcoming role to the rest of the scientific world. We would love to be known as a place that facilitates the acceleration of ethical science and ethical therapies, and therefore brings global relief to those in need.
In the U.S., hospitals generate an estimated 6,000 tons of waste per day. A few clinics are leading the way in transitioning to clean energy sources.
She decided to research alternatives for plastic in the medical sector and learned that cups could be reused and easily disinfected. All dentists routinely disinfect their tools anyway and, Stroetzel reasoned, it wouldn’t be too hard to extend that practice to cups.
It's a good example for how often plastic is used unnecessarily in medical practice, she says. The health care sector is the fifth biggest source of pollution and trash in industrialized countries. In the U.S., hospitals generate an estimated 6,000 tons of waste per day, including an average of 400 grams of plastic per patient per day, and this sector produces 8.5 percent of greenhouse gas emissions nationwide.
“Sustainable alternatives exist,” Stroetzel says, “but you have to painstakingly look for them; they are often not offered by the big manufacturers, and all of this takes way too much time [that] medical staff simply does not have during their hectic days.”
When Stroetzel spoke with medical staff in Germany, she found they were often frustrated by all of this waste, especially as they took care to avoid single-use plastic at home. Doctors in other countries share this frustration. In a recent poll, nine out of ten doctors in Germany said they’re aware of the urgency to find sustainable solutions in the health industry but don’t know how to achieve this goal.
After a year of researching more sustainable alternatives, Stroetzel founded a social enterprise startup called POP, short for Practice Without Plastic, together with IT expert Nicolai Niethe, to offer well-researched solutions. “Sustainable alternatives exist,” she says, “but you have to painstakingly look for them; they are often not offered by the big manufacturers, and all of this takes way too much time [that] medical staff simply does not have during their hectic days.”
In addition to reusable dentist cups, other good options for the heath care sector include washable N95 face masks and gloves made from nitrile, which waste less water and energy in their production. But Stroetzel admits that truly making a medical facility more sustainable is a complex task. “This includes negotiating with manufacturers who often package medical materials in double and triple layers of extra plastic.”
While initiatives such as Stroetzel’s provide much needed information, other experts reason that a wholesale rethinking of healthcare is needed. Voluntary action won’t be enough, and government should set the right example. Kari Nadeau, a Stanford physician who has spent 30 years researching the effects of environmental pollution on the immune system, and Kenneth Kizer, the former undersecretary for health in the U.S. Department of Veterans Affairs, wrote in JAMA last year that the medical industry and federal agencies that provide health care should be required to measure and make public their carbon footprints. “Government health systems do not disclose these data (and very rarely do private health care organizations), unlike more than 90% of the Standard & Poor’s top 500 companies and many nongovernment entities," they explained. "This could constitute a substantial step toward better equipping health professionals to confront climate change and other planetary health problems.”
Compared to the U.K., the U.S. healthcare industry lags behind in terms of measuring and managing its carbon footprint, and hospitals are the second highest energy user of any sector in the U.S.
Kizer and Nadeau look to the U.K. National Health Service (NHS), which created a Sustainable Development Unit in 2008 and began that year to conduct assessments of the NHS’s carbon footprint. The NHS also identified its biggest culprits: Of the 2019 footprint, with emissions totaling 25 megatons of carbon dioxide equivalent, 62 percent came from the supply chain, 24 percent from the direct delivery of care, 10 percent from staff commute and patient and visitor travel, and 4 percent from private health and care services commissioned by the NHS. From 1990 to 2019, the NHS has reduced its emission of carbon dioxide equivalents by 26 percent, mostly due to the switch to renewable energy for heat and power. Meanwhile, the NHS has encouraged health clinics in the U.K. to install wind generators or photovoltaics that convert light to electricity -- relatively quick ways to decarbonize buildings in the health sector.
Compared to the U.K., the U.S. healthcare industry lags behind in terms of measuring and managing its carbon footprint, and hospitals are the second highest energy user of any sector in the U.S. “We are already seeing patients with symptoms from climate change, such as worsened respiratory symptoms from increased wildfires and poor air quality in California,” write Thomas B. Newman, a pediatrist at the University of California, San Francisco, and UCSF clinical research coordinator Daisy Valdivieso. “Because of the enormous health threat posed by climate change, health professionals should mobilize support for climate mitigation and adaptation efforts.” They believe “the most direct place to start is to approach the low-lying fruit: reducing healthcare waste and overuse.”
In addition to resulting in waste, the plastic in hospitals ultimately harms patients, who may be even more vulnerable to the effects due to their health conditions. Microplastics have been detected in most humans, and on average, a human ingests five grams of microplastic per week. Newman and Valdivieso refer to the American Board of Internal Medicine's Choosing Wisely program as one of many initiatives that identify and publicize options for “safely doing less” as a strategy to reduce unnecessary healthcare practices, and in turn, reduce cost, resource use, and ultimately reduce medical harm.
A few U.S. clinics are pioneers in transitioning to clean energy sources. In Wisconsin, the nonprofit Gundersen Health network became the first hospital to cut its reliance on petroleum by switching to locally produced green energy in 2015, and it saved $1.2 million per year in the process. Kaiser Permanente eliminated its 800,000 ton carbon footprint through energy efficiency and purchasing carbon offsets, reaching a balance between carbon emissions and removing carbon from the atmosphere in 2020, the first U.S. health system to do so.
Cleveland Clinic has pledged to join Kaiser in becoming carbon neutral by 2027. Realizing that 80 percent of its 2008 carbon emissions came from electricity consumption, the Clinic started switching to renewable energy and installing solar panels, and it has invested in researching recyclable products and packaging. The Clinic’s sustainability report outlines several strategies for producing less waste, such as reusing cases for sterilizing instruments, cutting back on materials that can’t be recycled, and putting pressure on vendors to reduce product packaging.
The Charité Berlin, Europe’s biggest university hospital, has also announced its goal to become carbon neutral. Its sustainability managers have begun to identify the biggest carbon culprits in its operations. “We’ve already reduced CO2 emissions by 21 percent since 2016,” says Simon Batt-Nauerz, the director of infrastructure and sustainability.
The hospital still emits 100,000 tons of CO2 every year, as much as a city with 10,000 residents, but it’s making progress through ride share and bicycle programs for its staff of 20,000 employees, who can get their bikes repaired for free in one of the Charité-operated bike workshops. Another program targets doctors’ and nurses’ scrubs, which cause more than 200 tons of CO2 during manufacturing and cleaning. The staff is currently testing lighter, more sustainable scrubs made from recycled cellulose that is grown regionally and requires 80 percent less land use and 30 percent less water.
The Charité hospital in Berlin still emits 100,000 tons of CO2 every year, but it’s making progress through ride share and bicycle programs for its staff of 20,000 employees.
Wiebke Peitz | Specific to Charité
Anesthesiologist Susanne Koch spearheads sustainability efforts in anesthesiology at the Charité. She says that up to a third of hospital waste comes from surgery rooms. To reduce medical waste, she recommends what she calls the 5 Rs: Reduce, Reuse, Recycle, Rethink, Research. “In medicine, people don’t question the use of plastic because of safety concerns,” she says. “Nobody wants to be sued because something is reused. However, it is possible to reduce plastic and other materials safely.”
For instance, she says, typical surgery kits are single-use and contain more supplies than are actually needed, and the entire kit is routinely thrown out after the surgery. “Up to 20 percent of materials in a surgery room aren’t used but will be discarded,” Koch says. One solution could be smaller kits, she explains, and another would be to recycle the plastic. Another example is breathing tubes. “When they became scarce during the pandemic, studies showed that they can be used seven days instead of 24 hours without increased bacteria load when we change the filters regularly,” Koch says, and wonders, “What else can we reuse?”
In the Netherlands, TU Delft researchers Tim Horeman and Bart van Straten designed a method to melt down the blue polypropylene wrapping paper that keeps medical instruments sterile, so that the material can be turned it into new medical devices. Currently, more than a million kilos of the blue paper are used in Dutch hospitals every year. A growing number of Dutch hospitals are adopting this approach.
Another common practice that’s ripe for improvement is the use of a certain plastic, called PVC, in hospital equipment such as blood bags, tubes and masks. Because of its toxic components, PVC is almost never recycled in the U.S., but University of Michigan researchers Danielle Fagnani and Anne McNeil have discovered a chemical process that can break it down into material that could be incorporated back into production. This could be a step toward a circular economy “that accounts for resource inputs and emissions throughout a product’s life cycle, including extraction of raw materials, manufacturing, transport, use and reuse, and disposal,” as medical experts have proposed. “It’s a failure of humanity to have created these amazing materials which have improved our lives in many ways, but at the same time to be so shortsighted that we didn’t think about what to do with the waste,” McNeil said in a press release.
Susanne Koch puts it more succinctly: “What’s the point if we save patients while killing the planet?”
