On drug patent monopoly

When the Wall Street Journal (WSJ) accused the Biden administration’s latest effort to rein in drug costs by “seizing patents” and “stealing intellectual property”, it advanced its pro-business agenda by telling us only a half-truth. 

 True: under the 1980 Bayh-Dole act, research institutions receiving federal funds are allowed to patent inventions and license them to companies to commercialize them. Missing half, also true: the Bayh-Dole law also includes the government’s march-in right that allows the funding agency to effectively ignore the exclusivity of a patent awarded, and grant additional licenses to other reasonable applicants for an invention made using taxpayers’ funds, especially when it comes to achieving the health and safety of consumers.

 Bringing a useful drug to consumers is a complex process and typically involves many channels, from scientific institutions supported by federal grants, to research and development supported by private investors, and this can sometimes lead to contentious patent fights.  Moreover, one of capitalism’s cornerstones is the power of competition across the field. The WSJ can’t have it both ways when it embraces capitalism by citing the Bayle-Dole Act to support drug patent monopoly, while ignoring the other half of the law that would foster competition in drug development.

 At the time when drug cost inflation rate (15%) is the highest of all health sectors, our government has the moral obligation to stand up to Big Pharma, and the legal authority to bring regulations and enforce rules to make healthcare more affordable and available to all Americans.

 (Submitted on Dec 16; published in the GT on Dec 30, 2023)

Reflections on World Children's Day

Like many others, we have been watching the news of the Israel-Hamas war, everyday seeing images of fathers and mothers digging their infants from cement rubbles and craters, and entire communities in shock and despair beyond what we can ever imagine in our own lives. I also worry about how we are failing our children right in our own country, not for the lack of resources, but because we seem to have developed numbness to our own predicaments.  I needed to get my gut emotions out, without getting tangled in geo- or partisan-politics. This is finally what I could come up with.

 “In 1954, The UN designated November 20^th as “World Children’s Day” - to “offer each of us an inspirational entry-point to advocate, promote and celebrate children’s rights, and build a better world for children”. So how are we doing, nearly 70 years later? Or has the UN declaration remained but delusional buzzwords?

 Compared to those of the mid-20^th century, current statistics point to global improvements in many aspects of children’s health - mostly from better sanitation, nutritional and vaccination programs, and educational opportunities. However, more needs to be done in issues like child labor laws, gender equality and protection of girls. And tragically, an estimated 460 million children are living now in arm-conflicted zones, where 70-90 % of the casualties are borne by women and children.

 In the US, we have achieved mixed results. While the rate of reported illicit substance use has held steady, teen mortality is rising from more dangerous drugs; one in 5 teens suffers from clinical depression, and 20% of teens have seriously considered suicide. Gun violence is now the number one cause of death among American youth. Other disturbing reports: a recent increase in maternal and infant mortality rates; 17% of children experience food insecurity, 6% of children under age 6 are homeless. Rates are higher for racial minorities.

 I have confidence that our present world youth will find new technologies to mitigate the mess that we - their parents’ generation - have created: climate change, environmental pollution, or even the danger of unchecked artificial intelligence. But unless we have the political will to prevent or mitigate adverse childhood experiences (ACEs) now, we will continue to find ourselves in a cycle of complex PTSD that breeds despair or anger, and ultimately violence. ACEs are created when children, unable to navigate their own destinies, are caught at the intersection of social maladies that affect their families and communities: lack of decent housing and healthcare, low wages, racial discrimination, illicit drug use, crime, armed conflicts, and now a new scourge, social media disinformation. ACEs effects are life-long. Solutions are complex, yet basic in their principles. Charity is no substitute for social justice. Redressing the ACEs maladies is not a socialist agenda, but an investment in our shared social security and welfare.

 James Baldwin once stated: “Not everything that is faced can be changed, but nothing can be changed until it is faced” - a moral awakening that starts by examining how we all are interconnected to the problem - and to the solution. As Matthew Desmond pointed out in his book, “Poverty, by America”, many of us may be personally benefiting from systemic institutions that ubiquitously sustain financial inequities and poverty. Worldwide, we are by far the largest arm exporter, many of these weapons being used to indiscriminately kill civilians and children.

 If we can take pride in having landed on the moon and are now exploring the universe to find potential resources and places for mankind to expand, how can we ignore the most important investment right here, right now - our children? On this November 20, 2023, the theme for World Children’s Day is “For every child, every right”. The right to grow up safely, is it asking too much? 

 We all feel the consequences of childhood trauma and poverty left unattended. While a neglected child might become a “lone wolf” in our own neighborhood, or a future “terrorist” in a distant land, a child raised in loving care is, and will always be, a blessing for us all. So it is, the karma of our common humanity. Bless the children. All the children.”

(Submitted on Nov 7^th , published on Nov 14, 2023 in the Gazette Times, Corvallis)

On locking up mentally ill people...

Ms. Froma Harrop urged America to bring back locked mental facilities (Gazette Times, October 5) by citing horrific crimes and public nuisance committed by mentally ill people who “shouldn’t be out and about”; and she rightly pointed out that many of these individuals end up in county jails. But to conclude that the problem can be solved in clean, well-staffed psychiatric hospitals and “just make sure that they are locked” seems rather simplistic and insensitive.

President Kennedy’s Community Mental Health Act of 1963 - closing many psychiatric hospitals, failed not because of its good moral intention, but because America failed to build community centers and staff that would deliver the new compassionate out-patient care model. 

As Ms. Harrop admitted, most mentally ill people are not dangerous. Only 5% of crimes committed in the US are linked to a mental condition, and the diagnosis of mental disorder encompasses a diverse range of illnesses, very few of which need locked psychiatric facilities. And let’s not forget that incarceration itself carries significant devastating effects.

We can better use our resources by having more accessible mental health providers and clinics, and improving social determinants of health to mitigate factors that contribute to mental instability - risks such as family dysfunction, childhood trauma, juvenile delinquency, housing insecurity, poor education, and environmental and racial injustice. The list is long and complex,  and we lack the political will rather than resources to do it right. We can do better, but not by just building facilities to lock people in.

(Submitted on Oct 7, published in the GT on Oct 19, 2023)

More on Gun Regulations

I would like to thank Professor Wolf (GT opinion, April 28, 2023) for putting the Second Amendment in its proper historical perspective, and for emphasizing that the right of the people to bear arms was in reference to a well-regulated militia (i.e., our National Guard). However, to repeal it would be an impossible goal in the current political climate.

First, an amendment must be passed by a two-third majority vote in both of the House and Senate, or by a constitutional convention called for by two-thirds of the state legislatures. Then three-quarters of the voting states have to ratify it. I don’t see how we can gather such a super-majority nationally, even when most Americans support some degree of gun control. 

There are however other ways to achieve reasonable gun regulations. We can vote out legislators who refuse to restrict private ownership of assault-style weapon or take donations from the National Rifle Association (NRA). We must demand reforms inside the Supreme Court, whose members, appointed for life, no longer feel accountable for their extremist ideologies. The NRA is just an extension of the gun industry, so we should its end its tax-exempt status as a 501(c)(4) social welfare organization. We can stop the easy availability of firearms by enforcing expanded background checks and by adopting buyback programs that worked well in other countries. Most of all, we must dissociate ourselves from the myth of the American Rambo gun culture, and teach our children how to be strong and safe without having to carry a gun.

(Submitted on May 3, 2023; published in the Gazette Times, Corvallis, June 7, 2023)

Medicare For All

Why do Americans often say we have the best medicine in the world, yet many cannot access and pay for the health care when needed?

We have many effective tools to prevent diseases (e.g., vaccines) and to mitigate complications of many illnesses (e.g., statins for cardiovascular disease, Paxlovid for COVID-19) – medical interventions that should decrease health care costs -- yet these costs are increasing every year.

There are no simple answers to complicated issues, yet some are rather obvious but ignored or hushed. The bottom line is that the medical industrial complex, made of pharmaceutical and insurance companies, hospitals and private medical providers, will charge us “what the market is willing to pay.”

The Moderna and Pfizer COVID vaccines offer an example. The U.S. government provided $337 million in long-term capital to research the mRNA technology, then invested nearly $32 billion to help develop, produce and purchase COVID vaccines through March 2022, while these two companies made more than $100 billion in global revenues from sales in 2020-21 alone.

Yet for a vaccine that eventually costs only $1 to $3 per dose to manufacture, these companies have announced plans to charge $130 a dose in the U.S. when our government stops its vaccination program subsidies. They justified the new price as “consistent with the value” of the vaccine.

So how is the market value of a medical product determined? Basically, the marketer would use the estimated financial burden a particular disease causes to society, then aim the pricing around that target, to make the use of its product “cost-effective” enough to be recommended by official agencies and medical providers.

What the market is willing to pay is the price-fixing power of the companies, accounting for the cost of production, distribution, promotion and substantial payouts to corporate shareholders, the amount of these rewards being two or three times more than what they spent on research and development. Lucrative patents would keep competitors away and allow companies to control the market, while government regulations are minimized through lobbying.

In the end, medical advances seldom decrease care costs, since potential cost savings from appropriate medical interventions are scooped up as corporate profits. It is no surprise that our health care is the most expensive system in the industrialized world, accounting for 18.3% of our gross domestic product, while for Europeans it is around 11%, and with better outcomes in most health measures.

What can we do about this? While it is impossible to outline detailed solutions in a short essay, let’s start with two fundamental changes.

First, we have to stop believing in myths: (1) that our current system offers choices -- it does not: Providers and patients are boxed into medical and financial options set by insurance companies;

And (2), that everything run by the government is bad -- The U.S. Department of Veterans Affairs, Medicare and Medicaid services provide good essential services at lower administrative costs than private companies (3% vs. 18%, respectively); private Medicare Advantage Plans have not been proven to deliver better clinical outcomes than traditional Medicare, but eventually cost more to taxpayers.

Second, health care should not be treated as a market commodity, commercialized and manipulated by financial investors. While some investment profits are necessary to support medical progress, health care should be a shared social responsibility driven by scientific evidence and operating under public governance.

In the end, we all pay for each other’s illnesses. A healthy population is fundamental to societal safety and productivity. We can’t let private for-profit corporations decide who can afford health care. Medicare for All is the only reasonable solution.

(Published in the “As I See It” opinion column of the Gazette Times, Corvallis and Herald Democrat, Albany, April 13, 2023)