Regulation Too Often Shackles the Hands of Innovators
[Editor's Note: Our Big Moral Question this month is, "Do government regulations help or hurt the goal of responsible and timely scientific innovation?"]
After biomedical scientists demonstrated that they could make dangerous viruses like influenza even more dangerous, the National Institutes of Health (NIH) implemented a three-year moratorium on funding such research. But a couple of months ago, in December, the moratorium was lifted, and a tight set of rules were put in its place, such as a mandate for oversight panels.
"The sort of person who thinks like a bureaucratic regulator isn't the sort of person who thinks like a scientist."
The prospect of engineering a deadly pandemic virus in a laboratory suggests that only a fool would wish away government regulation entirely.
However, as a whole, regulation has done more harm than good in the arena of scientific innovation. The reason is that the sort of person who thinks like a bureaucratic regulator isn't the sort of person who thinks like a scientist. The sad fact of the matter is that those most interested in the regulatory process tend to be motivated by politics and ideology rather than scientific inquiry and technological progress.
Consider genetically engineered crops and animals, for instance. Beyond any reasonable doubt, data consistently have shown them to be safe, yet they are routinely held in regulatory limbo. For instance, it took 20 years for the AquAdvantage salmon, which grows faster than ordinary salmon, to gain approval from the FDA. What investor in his right mind would fund an entrepreneurial scientist who wishes to create genetically engineered consumer goods when he is assured that any such product could be subjected to two decades of arbitrary and pointless bureaucratic scrutiny?
Other well-intentioned regulations have created enormous problems for society. Medicine costs too much. One reason is that there is no international competition in the U.S. marketplace because it is nearly impossible to import drugs from other countries. The FDA's overcautious attitude toward approving new medications has ushered in a grassroots "right-to-try" movement, in which terminal patients are demanding access to potentially life-saving (but also potentially dangerous) treatments that are not yet federally approved. The FDA's sluggishness in approving generics also allowed the notorious former hedge fund manager Martin Shkreli to jack up the price of a drug for HIV patients because there were no competitors on the market. Thankfully, the FDA and politicians are now aware of these self-inflicted problems and are proposing possible solutions.
"Other well-intentioned regulations have created enormous problems for society."
The regulatory process itself drags on far too long and consists of procedural farces, none more so than public hearings and the solicitation of public comments. Hearings are often dominated by activists who are more concerned with theatrics and making the front page of a newspaper rather than contributing meaningfully to the scientific debate.
It is frankly absurd to believe that scientifically untrained laypeople have anything substantive to say on matters like biomedical regulation. The generals at the Pentagon quite rightly do not seek the public's council before they draw up battlefield plans, so why should scientists be subjected to an unjustifiable level of public scrutiny? Besides, there is a good chance that a substantial proportion of feedback is fake, anyway: A Wall Street Journal investigation uncovered that thousands of posts on federal websites seeking public comment on topics like net neutrality are fraudulent.
In other cases, out-of-date regulations remain on the books, holding back progress. For more than 20 years, the Dickey-Wicker Amendment has tied the hands of the NIH, essentially preventing it from funding any research that must first create human embryos or derive new embryonic stem cell lines. This seriously impedes progress in regenerative medicine and dampens the potential revolutionary potential of CRISPR, a genome editing tool that could someday be used in adult gene therapy or to "fix" unhealthy human embryos.
"Regulators and especially politicians give the false impression that any new scientific innovation should be made perfectly safe before it is allowed on the market."
Biomedicine isn't the only science to suffer at the hands of regulators. For years, the Nuclear Regulatory Commission (NRC) – an organization ostensibly concerned about nuclear safety – instead has played politics with nuclear power, particularly over a proposed waste storage facility at Yucca Mountain. Going all the way back to the Reagan administration, Yucca has been subjected to partisan assaults, culminating in the Obama administration's mothballing the project. Under the Trump administration, the NRC is once again reconsidering its future.
Perhaps the biggest problem that results from overregulation is a change in the culture. Regulators and especially politicians give the false impression that any new scientific innovation should be made perfectly safe before it is allowed on the market. This notion is known as the precautionary principle, and it is the law in the European Union. The precautionary principle is a form of technological timidity that is partially to blame for Europe's lagging behind America in groundbreaking research.
Besides, perfect safety is an impossible goal. Nothing in life is perfectly safe. The same people who drive to Whole Foods to avoid GMOs and synthetic pesticides seem not to care that automobiles kill 30,000 Americans every single year.
Government regulation is necessary because people rightfully expect a safe place to work and live. However, charlatans and lawbreakers will always exist, no matter how many new rules are added. The proliferation of safety regulations, therefore, often results in increasing the burden on innovators without any concomitant increase in safety. Like an invasive weed, government regulation has spread far beyond its proper place in the ecosystem. It's time for a weedkiller.
[Ed. Note: Check out the opposite viewpoint here, and follow LeapsMag on social media to share your perspective.]
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
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Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
- Breathing this way cuts down on anxiety*
- Could your fasting regimen make you sick?
- This type of job makes men more virile
- 3D printed hearts could save your life
- Yet another potential benefit of metformin
* This video with Dr. Andrew Huberman of Stanford shows exactly how to do the breathing practice.
This podcast originally aired on March 3, 2023.
Breakthrough drones deliver breast milk in rural Uruguay
Until three months ago, nurse Leopoldina Castelli used to send bottles of breast milk to nourish babies in the remote areas of Tacuarembó, in northern Uruguay, by way of ambulances or military trucks. That is, if the vehicles were available and the roads were passable, which wasn’t always the case. Now, five days per week, she stands by a runway at the hospital, located in Tacuarembó’s capital, watching a drone take off and disappear from view, carrying the milk to clinics that serve the babies’ families.
The drones can fly as far as 62 miles. Long distances and rough roads are no obstacles. The babies, whose mothers struggle to produce sufficient milk and cannot afford formula, now receive ample supplies for healthy growth. “Today we provided nourishment to a significantly larger number of children, and this is something that deeply moves me,” Castelli says.
About two decades ago, the Tacuarembó hospital established its own milk bank, supported by donations from mothers across Tacuarembó. Over the years, the bank has provided milk to infants immediately after birth. It's helped drive a “significant and sustained” decrease in infant mortality, says the hospital director, Ciro Ferreira.
But these children need breast milk throughout their first six months, if not longer, to prevent malnutrition and other illnesses that are prevalent in rural Tacuarembó. Ground transport isn't quick or reliable enough to meet this goal. It can take several hours, during which the milk may spoil due to a lack of refrigeration.
The battery-powered drones have been the difference-maker. The project to develop them, financed by the UNICEF Innovation Fund, is the first of its kind in Latin America. To Castelli, it's nothing short of a revolution. Tacuarembó Hospital, along with three rural clinics in the most impoverished part of Uruguay, are its leaders.
"This marks the first occasion when the public health system has been directly impacted [by our technology]," says Sebastián Macías, the CEO and co-founder of Cielum, an engineer at the University Republic, which collaborated on the technology with a Uruguayan company called Cielum and a Swiss company, Rigitech.
The drone can achieve a top speed of up to 68 miles per hour, is capable of flying in light rain, and can withstand winds of up to 30 miles per hour at a maximum altitude of 120 meters.
"We have succeeded in embracing the mothers from rural areas who were previously slipping through the cracks of the system," says Ferreira, the hospital director. He envisions an expansion of the service so it can improve health for children in other rural areas.
Nurses load the drone for breast milk delivery.
Sebastián Macías - Cielum
The star aircraft
The drone, which costs approximately $70,000, was specifically designed for the transportation of biological materials. Constructed from carbon fiber, it's three meters wide, two meters long and weighs 42 pounds when fully loaded. Additionally, it is equipped with a ballistic parachute to ensure a safe descent in case the technology fails in midair. Furthermore, it can achieve a top speed of 68 miles per hour, fly in light rain, and withstand winds of 30 miles per hour at a height of 120 meters.
Inside, the drones feature three refrigerated compartments that maintain a stable temperature and adhere to the United Nations’ standards for transporting perishable products. These compartments accommodate four gallons or 6.5 pounds of cargo. According to Macías, that's more than sufficient to carry a week’s worth of milk for one infant on just two flights, or 3.3 pounds of blood samples collected in a rural clinic.
“From an energy perspective, it serves as an efficient mode of transportation and helps reduce the carbon emissions associated with using an ambulance,” said Macías. Plus, the ambulance can remain available in the town.
Macías, who has led software development for the drone, and three other technicians have been trained to operate it. They ensure that the drone stays on course, monitor weather conditions and implement emergency changes when needed. The software displays the in-flight positions of the drones in relation to other aircraft. All agricultural planes in the region receive notification about the drone's flight path, departure and arrival times, and current location.
The future: doubling the drone's reach
Forty-five days after its inaugural flight, the drone is now making five flights per week. It serves two routes: 34 miles to Curtina and 31 miles to Tambores. The drone reaches Curtina in 50 minutes while ambulances take double that time, partly due to the subpar road conditions. Pueblo Ansina, located 40 miles from the state capital, will soon be introduced as the third destination.
Overall, the drone’s schedule is expected to become much busier, with plans to accomplish 20 weekly flights by the end of October and over 30 in 2024. Given the drone’s speed, Macías is contemplating using it to transport cancer medications as well.
“When it comes to using drones to save lives, for us, the sky is not the limit," says Ciro Ferreira, Tacuarembó hospital director.
In future trips to clinics in San Gregorio de Polanco and Caraguatá, the drone will be pushed to the limit. At these locations, a battery change will be necessary, but it's worth it. The route will cover up to 10 rural Tacuarembó clinics plus one hospital outside Tacuarembó, in Rivera, close to the border with Brazil. Currently, because of a shortage of ambulances, the delivery of pasteurized breast milk to Rivera only occurs every 15 days.
“The expansion to Rivera will include 100,000 more inhabitants, doubling the healthcare reach,” said Ferreira, the director of the Tacuarembó Hospital. In itself, Ferreira's hospital serves the medical needs of 500,000 people as one of the largest in Uruguay's interior.
Alejandro Del Estal, an aeronautical engineer at Rigitech, traveled from Europe to Tacuarembó to oversee the construction of the vertiports – the defined areas that can support drones’ take-off and landing – and the first flights. He pointed out that once the flight network between hospitals and rural polyclinics is complete in Uruguay, it will rank among the five most extensive drone routes in the world for any activity, including healthcare and commercial uses.
Cielum is already working on the long-term sustainability of the project. The aim is to have more drones operating in other rural regions in the western and northern parts of the country. The company has received inquiries from Argentina and Colombia, but, as Macías pointed out, they are exercising caution when making commitments. Expansion will depend on the development of each country’s regulations for airspace use.
For Ferreira, the advantages in Uruguay are evident: "This approach enables us to bridge the geographical gap, enhance healthcare accessibility, and reduce the time required for diagnosing and treating rural inhabitants, all without the necessity of them traveling to the hospital,” he says. "When it comes to using drones to save lives, for us, the sky is not the limit."