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.]
When doctors couldn’t stop her daughter’s seizures, this mom earned a PhD and found a treatment herself.
Twenty-eight years ago, Tracy Dixon-Salazaar woke to the sound of her daughter, two-year-old Savannah, in the midst of a medical emergency.
“I entered [Savannah’s room] to see her tiny little body jerking about violently in her bed,” Tracy said in an interview. “I thought she was choking.” When she and her husband frantically called 911, the paramedic told them it was likely that Savannah had had a seizure—a term neither Tracy nor her husband had ever heard before.
Over the next several years, Savannah’s seizures continued and worsened. By age five Savannah was having seizures dozens of times each day, and her parents noticed significant developmental delays. Savannah was unable to use the restroom and functioned more like a toddler than a five-year-old.
Doctors were mystified: Tracy and her husband had no family history of seizures, and there was no event—such as an injury or infection—that could have caused them. Doctors were also confused as to why Savannah’s seizures were happening so frequently despite trying different seizure medications.
Doctors eventually diagnosed Savannah with Lennox-Gaustaut Syndrome, or LGS, an epilepsy disorder with no cure and a poor prognosis. People with LGS are often resistant to several kinds of anti-seizure medications, and often suffer from developmental delays and behavioral problems. People with LGS also have a higher chance of injury as well as a higher chance of sudden unexpected death (SUDEP) due to the frequent seizures. In about 70 percent of cases, LGS has an identifiable cause such as a brain injury or genetic syndrome. In about 30 percent of cases, however, the cause is unknown.
Watching her daughter struggle through repeated seizures was devastating to Tracy and the rest of the family.
“This disease, it comes into your life. It’s uninvited. It’s unannounced and it takes over every aspect of your daily life,” said Tracy in an interview with Today.com. “Plus it’s attacking the thing that is most precious to you—your kid.”
Desperate to find some answers, Tracy began combing the medical literature for information about epilepsy and LGS. She enrolled in college courses to better understand the papers she was reading.
“Ironically, I thought I needed to go to college to take English classes to understand these papers—but soon learned it wasn’t English classes I needed, It was science,” Tracy said. When she took her first college science course, Tracy says, she “fell in love with the subject.”
Tracy was now a caregiver to Savannah, who continued to have hundreds of seizures a month, as well as a full-time student, studying late into the night and while her kids were at school, using classwork as “an outlet for the pain.”
“I couldn’t help my daughter,” Tracy said. “Studying was something I could do.”
Twelve years later, Tracy had earned a PhD in neurobiology.
After her post-doctoral training, Tracy started working at a lab that explored the genetics of epilepsy. Savannah’s doctors hadn’t found a genetic cause for her seizures, so Tracy decided to sequence her genome again to check for other abnormalities—and what she found was life-changing.
Tracy discovered that Savannah had a calcium channel mutation, meaning that too much calcium was passing through Savannah’s neural pathways, leading to seizures. The information made sense to Tracy: Anti-seizure medications often leech calcium from a person’s bones. When doctors had prescribed Savannah calcium supplements in the past to counteract these effects, her seizures had gotten worse every time she took the medication. Tracy took her discovery to Savannah’s doctor, who agreed to prescribe her a calcium blocker.
The change in Savannah was almost immediate.
Within two weeks, Savannah’s seizures had decreased by 95 percent. Once on a daily seven-drug regimen, she was soon weaned to just four, and then three. Amazingly, Tracy started to notice changes in Savannah’s personality and development, too.
“She just exploded in her personality and her talking and her walking and her potty training and oh my gosh she is just so sassy,” Tracy said in an interview.
Since starting the calcium blocker eleven years ago, Savannah has continued to make enormous strides. Though still unable to read or write, Savannah enjoys puzzles and social media. She’s “obsessed” with boys, says Tracy. And while Tracy suspects she’ll never be able to live independently, she and her daughter can now share more “normal” moments—something she never anticipated at the start of Savannah’s journey with LGS. While preparing for an event, Savannah helped Tracy get ready.
“We picked out a dress and it was the first time in our lives that we did something normal as a mother and a daughter,” she said. “It was pretty cool.”
A sleek, four-foot tall white robot glides across a cafe storefront in Tokyo’s Nihonbashi district, holding a two-tiered serving tray full of tea sandwiches and pastries. The cafe’s patrons smile and say thanks as they take the tray—but it’s not the robot they’re thanking. Instead, the patrons are talking to the person controlling the robot—a restaurant employee who operates the avatar from the comfort of their home.
It’s a typical scene at DAWN, short for Diverse Avatar Working Network—a cafe that launched in Tokyo six years ago as an experimental pop-up and quickly became an overnight success. Today, the cafe is a permanent fixture in Nihonbashi, staffing roughly 60 remote workers who control the robots remotely and communicate to customers via a built-in microphone.
More than just a creative idea, however, DAWN is being hailed as a life-changing opportunity. The workers who control the robots remotely (known as “pilots”) all have disabilities that limit their ability to move around freely and travel outside their homes. Worldwide, an estimated 16 percent of the global population lives with a significant disability—and according to the World Health Organization, these disabilities give rise to other problems, such as exclusion from education, unemployment, and poverty.
These are all problems that Kentaro Yoshifuji, founder and CEO of Ory Laboratory, which supplies the robot servers at DAWN, is looking to correct. Yoshifuji, who was bedridden for several years in high school due to an undisclosed health problem, launched the company to help enable people who are house-bound or bedridden to more fully participate in society, as well as end the loneliness, isolation, and feelings of worthlessness that can sometimes go hand-in-hand with being disabled.
“It’s heartbreaking to think that [people with disabilities] feel they are a burden to society, or that they fear their families suffer by caring for them,” said Yoshifuji in an interview in 2020. “We are dedicating ourselves to providing workable, technology-based solutions. That is our purpose.”
Shota Kuwahara, a DAWN employee with muscular dystrophy. Ory Labs, Inc.
Wanting to connect with others and feel useful is a common sentiment that’s shared by the workers at DAWN. Marianne, a mother of two who lives near Mt. Fuji, Japan, is functionally disabled due to chronic pain and fatigue. Working at DAWN has allowed Marianne to provide for her family as well as help alleviate her loneliness and grief.Shota, Kuwahara, a DAWN employee with muscular dystrophy, agrees. "There are many difficulties in my daily life, but I believe my life has a purpose and is not being wasted," he says. "Being useful, able to help other people, even feeling needed by others, is so motivational."