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.]
To Speed Treatments, Non-Traditional Partnerships May Be the Future
Drug development becomes even more complex as time passes. Increased regulation, new scientific methods, coupling of drugs with biomarkers, and an attempt to build drugs for much more specific populations – even individuals – all make clinical development more expensive and time-consuming. But the pressure is also constantly increasing to develop new, innovative medicines faster. So companies invest more dollars, with steadily decreasing yields in terms of such drugs on the market.
"Collaborations are in many cases the only possible solution--a powerful force driving old and new models."
The traditional models for clinical development are thus not producing the best results. Can collaboration between companies, academic institutions, and public (government and non-profit) organizations help solve the problem?
Collaboration has in fact yielded important developments in diagnostic and therapeutic products. However, truly collaborative efforts are in the minority. Particularly for biotech, diagnostic, device and pharmaceutical companies with stock traded on the public markets, or with funding from venture capital, private equity, or other investment-oriented platforms, there are strong drivers for limiting collaboration.
Particularly onerous are intellectual property (IP) concerns. Patent attorneys are normally terrified of collaborations, where the ownership of IP may be explicitly or implicitly impaired. Investment banks and fund managers are very nervous about modeling financial returns on new products where IP is shared. Development companies often have overt or implied policies greatly favoring internal development over collaboration. It could be argued that the greatest motivation behind the huge product in-licensing game is the desire to fully own product rights rather than to continue collaborations where the rights are not exclusive.
Bu the good news is that long-standing models and newer innovations in collaboration do work. Some examples are worth exploring. A huge influence currently on collaboration models across the spectrum is the revolution in immuno-oncology. More cash has gone into the development of drugs which enlist the immune system to attack cancer than any other field of drug development in history, some estimate by a factor of three. The great majority of current human clinical trials in the U.S. are in this field. There are over 200 separate drugs in development that attack a single target, PD-1--completely unprecedented. Due to the vast complexity of the human immune system, and also to the great promise that these drugs have shown in previously intractable cancers, the field has recognized that these drugs can only perform to full potential when used in combination. But the rationale for combinations is very obtuse, there are huge numbers of new drug targets and candidates, and there are many hundreds of institutions and companies involved in development of these combinations. Thus, collaborations are in many cases the only possible solution--a powerful force driving old and new models.
"As drugs have become more expensive, a huge drive has emerged, spurred by the brokers of health care, to limit the populations eligible to be prescribed an expensive new drug."
As marketing and reimbursement become increasingly complex, large commercial companies share the marketing of more products. Almost every large pharmaceutical and biotech company has products which are jointly sold with others.
Some pharmaceutical companies do a creditable job, often driven by ethical rather than economic concerns, of identifying drugs in their commercial or development portfolios which would be best in the hands of others, or which should be combined with products owned by others to achieve maximum patient benefit. Pfizer, for example, has a strong internal culture of not allowing products to become "dormant" in its hands, and actively seeks to collaboratively develop or license out such products.
Particularly in the immuno-oncology field, given the lack of firm knowledge about which combinations will work best in patients, both large and small companies are collaborating on both preclinical and clinical development. Merck, with its drug Keytruda, the leading anti-PD-1, has almost 1000 collaborative trials in progress. In most cases, the IP rights to a successful combination are not specified up-front; the desire is to see what works and deal with the rights and financial issues later.
Other companies have specifically engaged non-profit foundations and/or public bodies in collaborative efforts. This is of course not new--there is a very long history of pharmaceutical, diagnostic, and device companies either collaborating with the NIH or disease-focused foundations for development of products born from institutional research. The reverse is also true--both the NIH and foundations are often engaged to collaborate on development of products owned by industry. Sometimes these collaborations can be relatively complex. For example, Astra-Zeneca, Sloan Kettering, the Cancer Research Institute, and the National Cancer institute have engaged in a partnership to conduct clinical trials on combination cancer therapies involving the portfolio owned by Astra-Zeneca in combination with drugs owned by others, with device therapies and procedures, and with diagnostic products.
As drugs have become more expensive, a huge drive has emerged, spurred by the brokers of health care--the so-called 'insurance' companies and pharmaceutical benefit managers--to limit the populations eligible to be prescribed an expensive new drug. Thus, the field of "companion diagnostics" has crystallized. In a number of fields, including cardiology, urology, neurodegenerative disease, and oncology, developers of diagnostics and drugs seek each other out to jointly develop drug/diagnostic pairs which appropriately select patients for treatment. The number of such collaborations is escalating dramatically, although many large pharmaceutical companies have their own in-house programs.
"The lack of clinical trial data sharing has engendered some notable collaborative efforts."
But most large pharmaceutical companies are not in the business of selling diagnostic products, even if those products are so closely linked to a specific drug that they are included in the FDA-approved 'label' of that drug. As a result, some very collaborative relationships are emerging. Merck, which has a very large and active companion diagnostics development group, almost always seeks development and commercialization partners for internally innovated diagnostics – to the extent that the company actually gives away the rights and the commercial benefits of the diagnostic product. Such was the case with the Merck-developed Tau imaging agents related to Alzheimer's disease, which Merck made available without license to the entire industry. The company continues to drive such non-financial collaborations in other clinical disciplines.
Collaborations certainly take place between academic centers, but in comparison to others, they are few and of far less productive outcome. Many appear to be innovative and have great potential, but the results are often different. The collaboration between medical schools and research institutions in Northeast Ohio seems promising, but it is in large part just a means for gathering hard-to-find clinical trial patients into the giant local institutions, Case Western and the Cleveland Clinic. And the actual output of academic versus commercial development programs is usually poor. One new company recently did an exhaustive search for new clinical drug development candidates in a specific therapeutic area in academia and came up empty-handed, only to find a solid handful of candidate drugs "hiding" in pharmaceutical companies that they were willing to provide collaboratively or to license.
The lack of clinical trial data sharing has engendered some notable collaborative efforts. The Parker Institute for Cancer Immunotherapy initially set out to promulgate standards for clinical trial data collection to make trial results in the thousands of combination trials more comparable. However, after some initial frustration, they are now working collaboratively with biotech companies, academia, and pharmaceutical companies to drive forward specific combination trials that experts believe should be done.
Foundations and public organizations also enable or initiate collaborative research. The Prostate Cancer Foundation has aggressively put academic and hospital-based research institutions together with industry to push the development of new effective therapies and diagnostics for prostate cancer, with remarkable success. The Veterans Administration has recently embarked on an aggressive program of collaborations with industry (with the help of funding from the Prostate Cancer Foundation) to allow use of the VA population and the very complete patient records to start clinical trials and other development efforts that would otherwise be very difficult.
"The near future will bring some surprising collaborative successes in the development of new drugs, devices, and diagnostics, but of course, some serious disappointments as well."
Finally, the financial industry at times facilitates collaborations, although they are usually narrow. Fund managers often get two or more of their portfolio companies to pool assets and/or IP to push forward more rapid development, or to provide structure for developments that otherwise could not go forward due to size or other resource limitations. For example, Orbimed, a health-care-focused investment firm, consistently drives cross-company development efforts within its large portfolio of drug and device companies.
So collaborative efforts are very much alive and well, which is great news for patients. Current realities in science, politics, reimbursement, and finance are driving diversity in collaborative arrangements. The near future will bring some surprising collaborative successes in the development of new drugs, devices, and diagnostics, but of course, some serious disappointments as well. And the very negative influence of the IP profession on collaborations will not be soon defeated.
The rise of remote work is a win-win for people with disabilities and employers
Disability advocates see remote work as a silver lining of the pandemic, a win-win for adults with disabilities and the business world alike.
Any corporate leader would jump at the opportunity to increase their talent pool of potential employees by 15 percent, with all these new hires belonging to an underrepresented minority. That’s especially true given tight labor markets and CEO desires to increase headcount. Yet, too few leaders realize that people with disabilities are the largest minority group in this country, numbering 50 million.
Some executives may dread the extra investments in accommodating people’s disabilities. Yet, providing full-time remote work could suffice, according to a new study by the Economic Innovation Group think tank. The authors found that the employment rate for people with disabilities did not simply reach the pre-pandemic level by mid-2022, but far surpassed it, to the highest rate in over a decade. “Remote work and a strong labor market are helping [individuals with disabilities] find work,” said Adam Ozimek, who led the research and is chief economist at the Economic Innovation Group.
Disability advocates see this development as a silver lining of the pandemic, a win-win for adults with disabilities and the business world alike. For decades before the pandemic, employers had refused requests from workers with disabilities to work remotely, according to Thomas Foley, executive director of the National Disability Institute. During the pandemic, "we all realized that...many of us could work remotely,” Foley says. “[T]hat was disproportionately positive for people with disabilities."
Charles-Edouard Catherine, director of corporate and government relations for the National Organization on Disability, said that remote-work options had been advocated for many years to accommodate disabilities. “It’s a little frustrating that for decades corporate America was saying it’s too complicated, we’ll lose productivity, and now suddenly it’s like, sure, let’s do it.”
The pandemic opened doors for people with disabilities
Early in the pandemic, employment rates dropped for everyone, including people with disabilities, according to Ozimek’s research. However, these rates recovered quickly. In the second quarter of 2022, people with disabilities aged 25 to 54, the prime working age, are 3.5 percent more likely to be employed, compared to before the pandemic.
What about people without disabilites? They are still 1.1 percent less likely to be employed.
These numbers suggest that remote work has enabled a substantial number of people with disabilities to find and retain employment.
“We have a last-in, first-out labor market, and [people with disabilities] are often among the last in and the first out,” Ozimek says. However, this dynamic has changed, with adults with disabilities seeing employment rates recover much faster. Now, the question is whether the new trend will endure, Ozimek adds. “And my conclusion is that not only is it a permanent thing, but it’s going to improve.”
Gene Boes, president and chief executive of the Northwest Center, a Seattle organization that helps people with disabilities become more independent, confirms this finding. “The new world we live in has opened the door a little bit more…because there’s just more demand for labor.”
Long COVID disabilities put a premium on remote work
Remote work can help mitigate the impact of long COVID. The U.S. Centers for Disease Control and Prevention reports that about 19 percent of those who had COVID developed long COVID. Recent Census Bureau data indicates that 16 million working age Americans suffer from it, with economic costs estimated at $3.7 trillion.
Certainly, many of these so-called long-haulers experience relatively mild symptoms - such as loss of smell - which, while troublesome, are not disabling. But other symptoms are serious enough to be disabilities.
According to a recent study from the Federal Reserve Bank of Minneapolis, about a quarter of those with long COVID changed their employment status or working hours. That means long COVID was serious enough to interfere with work for 4 million people. For many, the issue was serious enough to qualify them as disabled.
Indeed, the Federal Reserve Bank of New York found in a just-released study that the number of individuals with disabilities in the U.S. grew by 1.7 million. That growth stemmed mainly from long COVID conditions such as fatigue and brain fog, meaning difficulties with concentration or memory, with 1.3 million people reporting an increase in brain fog since mid-2020.
Many had to drop out of the labor force due to long COVID. Yet, about 900,000 people who are newly disabled have managed to continue working. Without remote work, they might have lost these jobs.
For example, a software engineer at one of my client companies has struggled with brain fog related to long COVID. With remote work, this employee can work during the hours when she feels most mentally alert and focused, even if that means short bursts of productivity throughout the day. With flexible scheduling, she can take rests, meditate, or engage in activities that help her regain focus and energy. Without the need to commute to the office, she can save energy and time and reduce stress, which is crucial when dealing with brain fog.
In fact, the author of the Federal Reserve Bank of New York study notes that long COVID can be considered a disability under the Americans with Disability Act, depending on the specifics of the condition. That means the law can require private employers with fifteen or more staff, as well as government agencies, to make reasonable accommodations for those with long COVID. Richard Deitz, the author of this study, writes in the paper that “telework and flexible scheduling are two accommodations that can be particularly beneficial for workers dealing with fatigue and brain fog.”
The current drive to return to the office, led by many C-suite executives, may need to be reconsidered in light of legal and HR considerations. Arlene S. Kanter, director of the disability law and policy program at the Syracuse University College of Law, said that the question should depend on whether people with disabilities can perform their work well at home, as they did during Covid outbreaks. “[T]hen people with disabilities, as a matter of accommodation, shouldn’t be denied that right,” Kanter said.
Diversity benefits
But companies shouldn’t need to worry about legal regulations. It simply makes dollars and sense to expand their talent pool by 15% of an underrepresented minority. After all, extensive research shows that improving diversity boosts both decision-making and financial performance.
Companies that are offering more flexible work options have already gained significant benefits in terms of diverse hires. In its efforts to adapt to the post-pandemic environment, Meta, the owner of Facebook and Instagram, decided to offer permanent fully remote work options to its entire workforce. And according to Meta chief diversity officer Maxine Williams, the candidates who accepted job offers for remote positions were “substantially more likely” to come from diverse communities: people with disabilities, Black, Hispanic, Alaskan Native, Native American, veterans, and women. The numbers bear out these claims: people with disabilities increased from 4.7 to 6.2 percent of Meta’s employees.
Having consulted for 21 companies to help them transition to hybrid work arrangements, I can confirm that Meta’s numbers aren’t a fluke. The more my clients proved willing to offer remote work, the more staff with disabilities they recruited - and retained. That includes employees with mobility challenges. But it also includes employees with less visible disabilities, such as people with long COVID and immunocompromised people who feel reluctant to put themselves at risk of getting COVID by coming into the office.
Unfortunately, many leaders fail to see the benefits of remote work for underrepresented groups, such as those with disabilities. Some even say the opposite is true, with JP Morgan CEO Jamie Dimon claiming that returning to the office will aid diversity.
What explains this poor executive decision making? Part of the answer comes from a mental blindspot called the in-group bias. Our minds tend to favor and pay attention to the concerns of those in the group of people who seem to look and think like us. Dimon and other executives without disabilities don’t perceive people with disabilities to be part of their in-group. They thus are blind to the concerns of those with disabilities, which leads to misperceptions such as Dimon’s that returning to the office will aid diversity.
In-group bias is one of many dangerous judgment errors known as cognitive biases. They impact decision making in all life areas, ranging from the future of work to relationships.
Another relevant cognitive bias is the empathy gap. This term refers to our difficulty empathizing with those outside of our in-group. The lack of empathy combines with the blindness from the in-group bias, causing executives to ignore the feelings of employees with disabilities and prospective hires.
Omission bias also plays a role. This dangerous judgment error causes us to perceive failure to act as less problematic than acting. Consequently, executives perceive a failure to support the needs of those with disabilities as a minor matter.
Conclusion
The failure to empower people with disabilities through remote work options will prove costly to the bottom lines of companies. Not only are limiting their talent pool by 15 percent, they’re harming their ability to recruit and retain diverse candidates. And as their lawyers and HR departments will tell them, by violating the ADA, they are putting themselves in legal jeopardy.
By contrast, companies like Meta - and my clients - that offer remote work opportunities are seizing a competitive advantage by recruiting these underrepresented candidates. They’re lowering costs of labor while increasing diversity. The future belongs to the savvy companies that offer the flexibility that people with disabilities need.