Saturday, November 27, 2021

The profit motives of Big Pharma


Is Big Pharma More Interested in Profiteering Than Protecting Us From Coronavirus?


Gainesville, Florida

April 12, 1955 stands out as the brightest day in the history of vaccine development and public health when news of the discovery by Jonas Salk of a vaccine for the poliovirus was made public. The most venerated medical scientist of the 20th century, Jonas Salk, M.D., was hailed as a miracle worker. He further endeared himself to the public by underscoring every humans right to health care by refusing to patent the vaccine. He had no desire to profit personally from the discovery, but wanted the vaccine disseminated as widely as possible. Dr. Salk strongly rejected patenting and profiteering when he declared, “Could you patent the sun?”. He clearly recognized that vaccines and other medications should be accessible and affordable to all citizens as a necessary non-profit social service and health right of everyone.

Today, in sharp contrast, profiteering by Big Pharma too often reigns to the detriment of public health. Forty years of private corporatist Big Pharma and oligarch control of our economy has left the public totally exposed and ill-prepared to face the public health crisis of COVID-19. Because Big Pharma rarely invests in prevention, it has little motivation to invest in preparedness for a public health crisis. Drugs for prevention do not contribute to share-holder value and profit. Instead, cures are designed once a public health crisis strikes. The sicker we are the more profit they earn.

The government’s front line of defense in public health and safety emergencies has been starved of funding by a policy of austerity designed to fund tax cuts and subsidies to unregulated and unaccountable corporations and the rich. By eliminating the surplus coping capacities needed in an emergency such as COVID-19, the private for profit business model remains secure by defining Big Pharma corporations and big insurance as commercial entities. Like all businesses, their goal is to make money. Under this business model , the greed of casual inhumanity is built in and the common good of the citizens and nation is ignored. Using escalated price gouging and other overpricing methods, excluding many in the middle class, the poor, the aged, the disabled and the mentally ill is sound business practice policy since it maximizes profit. By also cutting research, the GOP and Trump administration has further promoted anti-science ideology by reducing the budget of the Center for Disease control (CDC) and disbanding the working group on pandemics of the National Security Council (NSC).

Big business and Big Pharma dominate our government and public health takes a back seat to the need for private profit. Many government leaders from both political parties share the same ‘profits over public health’ ideology, even though the Covid-19 pandemic clearly shows how our economic system has failed to serve our citizens by allowing these groups to privatize, sabotage, fragment and cripple our health, public health and other social services. No greater disconnect exists between the public good and private interests than in the U.S. system of for-profit Big Pharma. Just like large health insurance corporations, Big Pharma has the inherent tendency to invent new needs, disregard all boundaries and turn everything into an object for sale and big profit.

To fix this problem, we must nationalize the pharmaceutical industry and mandate that drug companies be converted to non-profit public service corporations that serve the public interest rather than being used by the 1% and oligarchs for unlimited profit. Additionally, we need comprehensive reform in the way we produce new drugs including a public manufacturing capacity/program for producing needed drugs and clinical trials that would produce new non-patent medications that stay in the public domain. Drugs would function as real social service items, not profit producing goods for a tiny group of oligarchs. With this fundamental reorientation of drug manufacture, drugs become more affordable for patients and society, promote innovation, strengthen efforts to assure safety and effectiveness, and upgrade the evidence available to prescribers and the public. Because drugs developed and manufactured through new public pathways remain in the public domain, they could be economically produced generically throughout the world, benefiting many nations.

Addiction to huge profits by the Big Pharma industry means that converting most drug production to the public domain won’t be easy or fast. Gerald Posner, author of “Pharma: Greed, Lies, and the Poisoning of America”, said, “Pharmaceutical companies view Covid-19 as a once-in-a-lifetime business opportunity”. The world needs pharmaceutical products, of course. For the new coronavirus outbreak, in particular, we need treatments and vaccines and, in the U.S., tests. Dozens of companies are now vying to make them.

“They’re all in that race,” said Posner, who described the potential payoffs for winning the race as huge. The global crisis “will potentially be a blockbuster for the industry in terms of sales and profits,” he said, adding that “the worse the pandemic gets, the higher their eventual profit.” The ability to make money off of pharmaceuticals is already uniquely large in the U.S., which lacks the basic price controls other countries have, giving drug companies more freedom over setting prices for their products than anywhere else in the world. During the current crisis, pharmaceutical makers may have even more leeway than usual because of language industry lobbyists inserted into an $8.3 billion coronavirus spending package, passed last week, to maximize their profits from the pandemic.”

Posner calculates that since the 1930s, the National Institutes of Health has put some $900 billion into research that drug companies then used to patent brand-name medications. The advocacy group “Patients for Affordable Drugs” notes that every single drug approved by the Food and Drug Administration between 2010 and 2016 involved science funded with tax dollars through the NIH, with hapless US taxpayers spending more than $100 billion on that research.

Among the drugs that were developed with some public funding and went on to be huge earners for private companies are the HIV drug AZT and the cancer treatment Kymriah, which Novartis now sells for $475,000.

Posner gives examples of Big Pharma industry making exorbitant profits from drugs produced with public funding. The antiviral drug sofosbuvir, which is used to treat hepatitis C, stemmed from key research funded by the National Institutes of Health. That drug is now owned by Gilead Sciences, which charges $1,000 per pill — more than many people with hepatitis C can afford; Gilead earned $44 billion from the drug during its first three years on the market.

Other examples include Mylan Pharmaceuticals, who have been price gouging the life-saving injectable epinephrine, EpiPen, by charging $300 for a product that costs less than $10 to make. The lack of ethics and price gouging from Mylan and other drug industry entities is an oft-repeated scenario by Big Pharma. They created nothing but paid billions that must be recovered through sales for a company that made their targeted product. They then generated skyrocketing returns through escalating price gouging, and even avoided taxes through inversion.

This is not the first time that Mylan has attempted to monopolize a drug to raise prices on a relatively cheap product to produce profits. In 2000, Mylan entered into agreements with the providers of the active pharmaceutical ingredient for widely prescribed anti-anxiety drugs lorazepam and clorazepate. The effect was to deny competitors access to ingredients necessary to produce these drugs generically. Having done so, Mylan inflated the drugs prices by 2,000 percent and 3,000 percent respectively. Mylan was dragged into court by 32 state attorneys general and the U.S. Federal Trade Commission. The settlement basically required Mylan to disgorge all of the ill-gained profits in what was then the largest settlement with a drug manufacturer, amounting to well over $100 million.

But Mylan is not the only offender. Valeant Pharmaceuticals between 2015 and 2016 raised the prices of Isuprel and Nitropress by 528 percent and 212 percent respectively; from 2013 to 2016, Cuprimine by 5,787 percent and Benzaclin and Retina-A Micro by 1,800 percent each; and from 2011 to 2016 Carac and Targretin 1,700 percent each. The drug Syprine went up by 3,200 percent since 2011.

Until we nationalize the pharmaceutical industry and mandate that drug companies be converted to non-profit public service corporations that serve the public interest rather than being used by the 1% and oligarchs for unlimited profit, here are seven steps/ suggested policies that could be taken today that would help millions of our fellow Americans who are unable to access prescription drugs because of high out-of-pocket costs.

1). Establish a national formulary of medically necessary drugs to include the safest, most effective, and least expensive options. Provide all residents with full coverage of formulary drugs without copays or deductibles.

2). The U.S. spends more on prescription drugs than any other nation. Each year, prices rise far beyond the cost of development and production, straining family and government budgets. Negotiate with manufacturers to lower prices of branded drugs. If negotiations fail, issue a “compulsory license” to allow generic manufacturing. Increase public funding for development of non- patented drugs.

3). Today’s patent process keeps drug prices high and discourages innovation by rewarding minor tweaks to existing medications. Research funded by tax dollars can be patented and sold to private manufacturers. Prohibit new patents for trivial changes to existing drugs or “me too” drugs. Publicly fund development of treatments through non-commercial researchers, prioritizing drugs with high clinical value and for conditions neglected by the industry. Repeal the Bayh-Dole Act that allows publicly funded researchers to patent and sell discoveries.

4). Most clinical trials are now conducted by private drug firms, often using unsound methods and selective reporting. Regulators approve drugs based on small increases in “surrogate” endpoints, which are less safe and reliable than clinical results. Corporate ownership of trial data can hide safety problems and obstruct further research. Require regulators to fund and supervise the majority of clinical trials to maintain safety standards and facilitate innovation for high-need treatments. Increase standards for clinical trials, which should compare new drugs to existing drugs instead of placebos, and assess hard clinical outcomes instead of surrogate endpoints. Increase transparency by making all patient-level trial data publicly available.

5). Regulators often allow unsafe drugs to reach the market. Agencies are funded primarily by drug company fees, creating conflicts of interest. A majority of drugs receive “expedited review,” with weaker standards of evidence. Fund regulators with public money to ensure independence and objectivity. Strictly limit expedited review and surrogate endpoints to drugs offering genuine clinical advances. Limit market exclusivity to drugs demonstrating superiority over existing treatments.

6). After approval, regulators neglect to monitor drug safety and efficacy in the field, or enforce mandated postmarketing studies by drug firms. Agencies fail to issue safety warnings or remove unsafe drugs from the market. Increase funding for regulators’ postmarketing surveillance and increase their power to issue safety warnings and remove drugs from the market. Require drug firms to promptly perform and submit safety studies after drugs are in use.

7). Drug firms spend billions on advertising and marketing, including gifts and education programs for health providers. Drug ads often make misleading or inaccurate claims, but are poorly monitored by regulators who delegate most oversight to third parties. Eliminate conflicts of interest by ending the corporate funding of approval agencies. Strengthen funding for direct monitoring of drug marketing and increase sanctions for misleading or off-label promotions. Prohibit drug firms from funding continuing education programs for medical professionals.

F. Douglas Stephenson , LCSW, is a retired psychotherapist and former instructor of social work in the University of Florida Department of Psychiatry. He is a member of Physicians for a National Health Program.

Mental health professionals practicing across state lines.

Since the pandemic telehealth has mushroomed as psychotherapists have closed their offices and moved their practices to telehealth only. This move has saved them a lot of money in office rent, utilities, commute expenses, parking, etc.

The move to telehealth which makes it easy to practice across state lines as most state professional licensing regulations  limit a professional practice to the state the professional is licensed in and the place the professional  and client is situated when the professional provides the service.

Requests, and provision of service to clients in states other the state in which the professional is licensed and is located is out of compliance with licensing regulations. This has generated some anxiety on the part of the professionals who are faced with the possibility of providing services to clients our of their state.

Practicing across state lines seems be an anachronistic regulatory interference from days gone by. We are living in an age of telehealth and a global economy. Does anyone think that psychotherapists in New Jersey are better qualified than ones in New York or Maryland or Florida or West Virginia? Maybe state laws licensing professionals 100 years ago made some sense but I don't see how they make any sense currently.

The chance that a psychotherapist would be prosecuted for practicing across state lines seems ludicrous to me. It seems that the therapist would have a better chance of being struck by lightning or winning a multi million dollar lottery jackpot.

I appreciate that people want to practice within the regulatory guidelines within their state but when those regulatory guidelines interfere with carrying out ethical responsibilities for patient care, it seems to me that the ethical responsibilities take precedence, at least in my book. There are far greater egregious breaches in ethical conduct that could be and should be professionally addressed. 

The biggest one in this day and age is allowing insurance companies to dictate the guidelines for practice. Therapists who allow this to happen are far more culpable for malpractice. It happens all the time. The first question I get asked usually in a request for service is "Do you take my insurance?" How have we allowed insurance reimbursement to be the primary consideration for access to mental health care? This barrier and obstacle is a primary violation of a community mental health model where the barriers to care should be lowered as much as possible to provide accessibility to service. The provision of mental health services is more than a mercenary activity governed by a profit motive. Professions, if they are truly professional, have an obligation to serve their communities regardless of the ability to pay. Willingness to pay is another story.

Friday, November 26, 2021

U.S. tops all first world countries in Covid deaths per million.

 Click on graph to enlarge.

What are the factors which contribute to the U.S. being the most deadly country from Covid-19 deaths in the world?

How is this outcome to be explained?

Trust in a benevolent universe is a key to spiritual health.

 Even if your spirituality does not include a Supreme Being, children need to feel that the universe smiles on them. Einstein said that the most important decision each person makes is deciding whether or not this is a friendly universe.

Dr. Laura Markham, Great Spiritual Lessons Every Child Should Learn

Laura Markham is no relation to me and I don’t know her. However, I admire her work.

As I read and think about this quote, it seemed to me that this is an important decision for adults as well as children. To what extent is one of the foundational purposes of psychotherapy to help people shift their perception from a world of malevolence to one of friendliness?. How do we help our clients shift their perception from a malevolent universe in which they feel victimized to a benevolent universe in which they are loved unconditionally?

Friday, November 19, 2021

Lethal drug overdoses in the year ending in April 2021 killed 100,000 people.

 Anybody notice this?

Lethal drug overdoses in the year ending in April 2021 killed 100,000 people.

In my practice I know far more people who have died from drug overdoses than from Covid-19.

The interesting observation is that people have much more control over lethal drug overdoses than they do of Covid-19 in the sense that the exposure to the agent of death is under the individual's control.

What are the factors that contribute to the high level of substance misuse in the United States?
What can we do as psychotherapists do to ameliorate the suffering that contributes to this phenomenon?

Thursday, October 28, 2021

Normal people scare me.


What is normal?

By David G. Markham, L.C.S.W. R.

I have a bumper sticker that says "Normal People Scare Me?"

What is normal?

That is a question that as a Psychiatric Social Worker for over 50 years, I have struggled with for five decades.

That is a question which many of my clients ask me who come to see me because they are mystified, and in great distress. Often these clients grew up in dysfunctional families, have been through a failed marriage, and now find themselves in their 40s with problems in their love lives, at work, with their neighbors, or in the social circle of friends and they wonder who is crazy, them or me? And because they grew up in crazy families they really don't know what normal is. And so they have come to ask me if they are nuts? What they want from me is a point of reference. They want a navigational north star. What they want most of all is validation, affirmation, and reassurance. They want to hear, if appropriate, that their intuition, their instincts, might be right after all, when the whole world seems crazy to them and they are being told that they are the one that is crazy. They want to check it out.

And what am I to say? Am I the arbitrator of what is normal? How do I set myself up as the navigational north star? What does psychology, or social work, or counseling have to offer? What does philosophy or religion or the humanities have to offer? What can I possibly say to this person that will help them find their way?

M. Scott Peck, is a Christian Psychiatrist, who wrote a book in the 80s that was immensely popular entitled, The Road Less Traveled. He is the only person I have ever heard talk about the idea of a therapeutic depression. He says that sometimes people struggle to extricate themselves from dysfunctional relationships and when they have succeeded and they are healthy, and they look back and realize how screwed up everyone else is, they get depressed. 

When the Buddha became enlightened he was off the wheel of samsara and free to go on to nirvana but he chose to stay and help his fellow humans and so his nickname is the Compassionate Buddha. Karl Jaspers, a great American Psychiatrist-Philosopher, defined tragedy as awareness in the excess of power by which I think he meant, to be aware of how things could be, should be, ought to be, and not having the power to make it happen is a tragedy because that awareness fills us with sadness, helplessness, and loneliness sometimes. That's why they say that ignorance is bliss, because if we didn't know any better it wouldn't bother us, but we know and can't do anything about it.

And so, what is the answer to the question, what is normal? There are a few ideas I would like to share with you that might help us figure out a way to begin to answer that question.

Lawrence Kohlberg, a Psychology Professor at Harvard, divided moral development into three stages: pre-conventional, conventional, and post-conventional. At the first stage of moral development people do the right thing to avoid punishment and to gain approval of others. At the second stage people do the right thing because they want to be a "good boy" or a "good girl" and they are following a moral code like the Ten Commandments or the Law of The Land. In the third stage people do the right thing because of their appreciation of the interdependence of life and the welfare of other living things, and some universal principles of life: Cosmic Consciousness. At this third stage people begin to realize that there can be such a thing as an immoral law like segregation. People recognize that legality and morality can be two different things.

If by normal we mean conventional then Martin Luther King, Jr. wasn't normal, nor was Jesus of Nazareth, nor Buddha, nor Mahatma Gandhi, nor Nelson Mandela. Nor was Frederick Douglas, Henry David Thoreau, Joan of Arc, or Susan B. Anthony.

I have worked for over 50 years in the Mental Health Field and one thing that I and my colleagues recognize is that you have to be a little crazy to keep from going insane. Being crazy has a long and revered tradition even if not often acknowledged. The court jester made fun of the pomposity and arrogance of the king with his satire and was seen as a necessary part of the court culture to help keep the King's feet on the ground. In First Corinthians, 4th chapter, 10th verse, St. Paul talks about being a fool on Christ's account. And everyone loves a clown who mocks and pratfalls and spoofs every aspect of our humanity.

How do we become Holy Fools? How do we step outside the bounds of "normal" in a way that contributes to our growth and development? Playing the fool, refusing to be "normal", listening to one's own drummer and marching to one's own beat, has a long and illustrious history which has captured the curiosity of the timid, and the delight of the child like sensibility such that Jesus said we can't enter the Kingdom unless we become like little children. I wonder sometimes if "normal" people go to heaven. As I get older, I doubt it more and more.

There was a psychiatrist from Georgetown University, who is now dead, named Murry Bowen, who developed a whole theory called family systems theory. Dr. Bowen has revolutionized the way we think about symptomatic, dysfunctional, and not normal behavior.

Back in the old days we used to study the individual's personality to see what made him or her tick. We could do the MMPI, the Minnesota Multiphasic Personality Inventory, or the Rorschach, the ink blot test, to understand better the individual's personality traits. We believed that if we understood the individual's personality traits well enough we could predict how they might behave in future situations. But then about 50 years ago along came systems theory which says that how people behave may have more to do with the context of the situation they find themselves in than their individual personality traits. For example, we all have hundreds of different sides to our personality. You can be one way with your mother and one way with your father. You may be one way with your significant other, and a different way with your friend. Each person that we have a relationship with, and each situation we find ourselves in, brings out a different side to our personality.

Dr. Bowen said that the goal of our individual growth and development is what he called "differentiation". What he meant by that was the degree to which we have become differentiated from our family of origin. In other words, to what extent do you have a mind of your own, can you stand on your own two feet, are you captain of your own ship, and master of your own fate?

We are all born into a family. And from our family we receive our "psychological legacy". The psychological legacy is made up of the beliefs, opinions, values and ways of doing things, or practices, of the family. There is the Markham way of doing things, the Hood way of doing things, the Reidell way of doing things, and the DelaCosta way of doing things.

If you ask people why they believe certain things, or why they do certain things they will tell you "Well, I don't know. That's the way I was raised" or "That's the way I was brought up." So if you ask people why they are Jewish and not Catholic, or Baptist and not Methodist, chances are they will tell you that they were raised Jewish etc. Why do we speak English and not Chinese? Is there something genetic about it? Does it run in families?

Most of us do not question our psychological legacy until we have children of our own because now we must decide, if we are thoughtful about it, the extent to which we want to raise our children the same way we were raised, and the extent to which we want to do it differently.

"Differentiation" does not mean you have to do things differently. It only means that you have made a conscious decision about it, and not just go along with it unthinkingly. So there are some good beliefs, values, and practices which you believe were good for you and you want to pass them on to your children, and there may have been some bad beliefs, values, and practices which you consciously decide you would like to do differently and pass them differently on to your children.

And so you have started to have a mind of your own. You are standing on your own two feet, and not just going along with the herd, with your conditioning.

Now, if you want to change some of the beliefs, opinions, values, and practices from the family of origin, or any group of participation, the group will experience this as "rocking the boat", "going against the grain", "disturbing the status quo", and "upsetting the apple cart". The tension and the anxiety in the group will go up.

The members of the group will feel threatened and they will do one of three things or if they are skilled,  they may do any combination of these things. They will say that you are being bad, mad, or disloyal. That is, they will say that you are being bad, naughty, and that you need to be punished. So they will try to scold you, send you to your room, deny you the privileges of the group, or they will say that you are mad, meaning crazy, and will dismiss you with statements like "Ah, you're nuts" you should see a shrink and get on some medication, or they will ridicule and mock you, or three, they will say that you are disloyal, a traitor, the Benedict Arnold of the group who is no longer worthy of membership and they will shun you, excommunicate you, send you into exile, or otherwise let everybody know that you are a persona non grata.

How do you handle it when the group you love and care about thinks you are not normal? Bowen's theory suggests three steps in managing the group. First, you need to take a clear stand and a clear position. Waffling around usually doesn't help. Second, when the group says that you are bad, mad, or disloyal, you need to stick to your guns. They would love nothing more than for you to relieve their tension and anxiety by "knuckling" under. And third, and here is the critical step, you need to maintain a connection. You can't let them cut you off. If there is a cut off then the emotional system is paralyzed and stagnates and the conflict and dysfunctional behavior can be transmitted to future generations. So we all know the story about Romeo and Juliet or the Hatfields and  the McCoys where conflicts in preceding generations had a way of transmitting themselves to subsequent generations. So maintaining a connection is critical to the growth and development of all concerned. The goal here is not eventual agreement although that can sometimes happen, but rather respect. We can agree to disagree and still stay in relationship.

So the point here is that sometimes it is bad to be normal if by normal we mean submitting ourselves to the status quo, to the conventional wisdom. 

I am for continuous quality improvement, for continuing growth and development until we become the fully realized human being that we are meant to be. Bowen said that descriptively, we could put differentiation on a scale of 1 - 10 and most adults are lucky if they make it to 5. Jesus made it to 10. Buddha made it to 10, and other enlightened masters made it to 10. They became fully realized, aware, conscious human beings, and we each can do that too, but not if we are content to be normal. 

We all can be post conventional when we become aware of the uniqueness and the interdependence of all life. As a differentiated, mature person we become aware of the inherent worth and dignity of every person, the importance of justice and compassion in our human relations, the acceptance of one another and the encouragement of each other's growth, the free and responsible search for meaning, respect for the right of conscience, the goals of peace, liberty, and justice for all, and the respect for the interdependent web of existence.

As I said at the beginning, "Normal People Scare Me." 

Remember "You Are Unique Just Like Everybody Else."

Because of your uniqueness you are destined for greatness, and being great means that you have to take the road less traveled, you have to take the high road and not the low road, and taking the high road means that you are traveling way above normal. You are becoming a Holy Fool. People thought Jesus was nuts and they killed him. People thought Martin Luther King was nuts and they killed him. People thought Gandhi was nuts and they killed him. People thought Malcom X was nuts and they killed him. People thought Joan of Arc was a heretic and they burned her at the stake. People thought Susan B. Anthony was nuts and they imprisoned her. It is dangerous to be post conventional because the normal people will kill you. However, like Frank Sinatra you can sing I did it "My Way" and maybe even make a significant contribution to the world. Gandhi said "Whatever you do will be insignificant, but it is very important that you do it."

Being normal is nothing to strive for. 

Actualizing our potential challenges us to be extraordinary. 

Actualizing our potential challenges us to pursue truth and meaning wherever it may take us, to love each other no matter how "different" we perceive the other to be, to celebrate life even when the Eyores of the world are full of doom and gloom.

Don't be afraid to speak your truth and let your little light shine.