In the first installment of PhRMA, I brought to light the dissatisfaction many med students have with the lack of material and course study in addiction and its treatment in their curriculums. While professors claimed the education is adequate, hundreds of Harvard med students took it upon themselves to organize their own training. In this installment I’ll expose the shortcomings of the academic/pharmaceutical relationship and its devastating impact on our everyday lives and, in my opinion, how this marriage extends America’s second opiate/opioid epidemic.
According to his Tufts University website bio, J oseph A. DiMasi, PhD is an Associate Professor who holds the position of Director of Economic Analysis & Research with an area of expertise in R& D efficiency, approval success rates, development and regulatory approval time metrics, impact of regulatory policies, economics of innovation in the pharmaceutical and biotechnology industries.
Last April, a group of Tufts students called him out on a paper he published pegging the costs of development of a new drug at $ 2.87 billion dollars, or an increase of nearly 2 ½ times what he stated the cost to be in 2007. The students claim the 2.87 billion figure is inflated. They also believe the paper’s sole purpose is for the use of pharmaceutical companies to preserve the status quo, increase drug prices and their bottom line. They’re claiming DiMasi’s relationship with the pharmaceutical companies presents a conflict of interest for his research and are calling for him to reveal his pharmaceutical company sponsors. In response, a Tufts professor who is also the Center for the Study of Drug Development’s director stated it’s their policy to not disclose the names of sponsor pharmaceutical companies.
The Tufts’ students were joined by Harvard students and AIDS Coalition to unleash power. They first assembled at the Tuft’s Medical Center then carried signs and chanted as they moved to Tufts Center for the Study of Drug Development – where DiMasi is located – and staged a die-in. According to one demonstrator the die-in was symbolic of people who are dying around the world because they cannot access medicine.
The Harvard student newspaper, The Crimson, stated that the demonstration was a part of a worldwide protest called ‘ Pharma Fools Day.’ The protests took place in 12 cities around the world, including London, Johannesburg, Sydney, and New Delhi, according to movement’s website.”
Pharma Fools Day’ raises all sorts of interesting facts and questions that need to be explored. It has shined a bright light on the questionable price increase on all drugs and the lack of access in underdeveloped countries. People are dying preventable deaths because they’re poor. But more to my point, these young med students have also exposed the porous boundary between the pharmaceutical industry and our universities that has had a dramatic effect on growth of the epidemic and the care and treatment of addiction.
There was once a time when notable research universities and hospitals were held in the highest regard. It was a time when science was explored because of the lifesaving impact discoveries could have on mankind; and also a time when cures were found for diseases. I can’t think of a better example then Dr. Jonas
Salk and his team of scientists and researchers at the University of Pittsburgh. In the late 4 0s and early 50s the Polio epidemic was growing and ravaging young American children. Parents were panicking and the country was desperate for a cure. In 1952 – 58,000 cases of Polio were reported that year – Salk and his team began clinical trials on what became the first effective polio vaccine. It was a success and by 1961 only 161 cases were reported in the U .S.
During a TV interview in 1952 Dr. Salk was asked “who owned the patent to the vaccine to which he replied, “The people, I would say.
There is no patent. Could you patent the sun? ” Dr. Salk’s vaccine was never intended to turn a profit but rather to end human suffering and carnage. His discovery nearly eradicated Polio from the face of the planet. That is how it was in the good ole days.
It’s also important to note that according to the International Drug Price Indicator Guide, today’s ( 2015) wholesale cost of a single dose of Dr. Salk’s vaccine is twenty-five cents.
But those days are firmly behind us and perhaps never to be seen again in this great country of ours thanks to an obscure law passed in 1980. In this era, the economy was in the tank and congress was looking for a lifeline to prop it up. With around $ 75 billion tax-payer dollars a year being spent by government on R& D with a large portion going to universities, patent rights became an economic target. Congress couldn’t agree on any way forward for patents derived from university discoveries whose R&D was financed by tax dollars. There was a stalemate until Democratic Senator Birch Bayh and Republican Senator Bob Dole introduced The Bayh–Dole Act or Patent and Trademark L aw Amendments Act that gave ownership of the patents to the universities. Although the initiative was never intended to enrich universities, it did give them the right to negotiate lucrative licensing deals with the private sector.
The Bayh– Dole Act changed everything. It established a business relationship between the medical centers and the pharmaceutical industry. Dr. Salk’s days of concern for humanity have been replaced by PhRMA’s insatiable appetite for profits. It opened the door for PhRMA to walk through with Santa Claus sized bags full of money. Their infuences threaten the very core principles of medical research. Independence and impartiality gave way to shady backroom deals hidden from the public view.
Before Bayh– Dole there was an arms-length relationship between pharmaceutical companies and research universities. They’d give grants to universities for testing new drugs and hope for the best. They’d had no infuence on the study design, the data or subsequent papers written about the test. The success or failure of the drug efficacy laid solely in the drug itself.
Today, the pharmaceutical companies refer to research professors as mere ‘ rented white coats’ whose function is to sign off on their new drugs before they go to the FDA for approval. The rented white coats are also expected to sign research papers written by anonymous and unqualified authors toting the efficacy of the new drug – and they often do.
Why do they do it; because it pays well and they can get away with it. Like Tufts’ non-disclosure policy, many of the top research universities refuse to identify sponsor pharmaceutical companies. Today it is common place for a rented white coat to be a consultant to the very same pharmaceutical company they’re supposed to be conducting un-bias independent research for. They also can be found in great numbers on advisory boards and even on the board of directors. No one seems to be concerned about any confict of interest.
Moreover, the focus of medical research has shifted away from our national needs and interests to whatever is most profitable for the pharmaceutical companies. An overwhelming number of our medical centers now view fulfilling pharmaceutical industries needs as a legitimate purpose of an academic institution and at the expense of promising therapies. The research agenda set by PhRMA is zeroed in on drug development and not causes, or mechanisms or prevention of disease. I often wonder what Polio would be like today had The Bayh– Dole Act been enacted in 1950 as opposed to 1980 – and what addiction would look like if congress did its job twenty years ago when the epidemic was just getting started.
If you’re feeling a bit ripped off, you’re not alone. You and I are handing money directly to the pharmaceutical companies by paying for their research and development of these drugs in the form of taxpayer funded research grants awarded to medical centers. To add insult to injury; students at Tufts argue that DiMasi did not take grants into consideration in his formulation of the development costs of a new drug being $ 2.87 billion.
Big PhRMA has infiltrated and taken over our institutions. PhRMA’s lobbyists and their money own congress, they have university medical research professors and deans on their payroll; PhRMA representatives speak in their lecture halls; their lobbyists, drug review panel members and non-profit groups control the FDA and the revolving door between the private sector, PhRMA academic professors and the FDA keeps PhRMA’s people in key, top level decision-making positions.
Under PhRMA’s direction and leadership, you can expect our opiate/opioid epidemic to continue into perpetuity without some type of intervention. PhRMA is in the business of selling pills and they will do whatever it takes to achieve their mission. Their interests are too purely married to money even at the expense of human life and suffering. We’re in the middle of an opiate/opioid epidemic and one would think our academic medical centers would be hard at work looking for solutions. But any attempt to curb the epidemic – whether it be medical or political – would cut deeply into PhRMA’s profits. Considering PhRMA sets the research agenda, I’m fairly confident we will not be seeing our medical centers working to solve the problem any time soon. The CDC’s opioid prescribing guide lines was a good first step but it will take far more to force this money driven juggernaut into abandoning their opioid trade.
However, I have found hope in our young medical students. There appears to be an awakening on college campuses across the county on a magnitude never before seen; the recognition of curriculums polluted by corporate sponsorship and a wholesale rejection of educators who support it. It appears as though these med students are far more dialed into opioids and addiction than their professors. They seem to be able to see right through Big PhRMA’s white washing PR campaigns with a clarity that should be envied by everyone in the field. But more importantly, they’re organizing and taking action. These students are forming groups like ‘White Coats for Recovery’ and taking action – ‘PhRMA Fools Day’ – by drawing attention to the lies promoted by Big PhRMA. I wholly support these groups of college medical students and I hope you do too because it is through their voices the truth will be heard and that can only help end America’s Second Opiate/Opioid Epidemic.
John Giordano DHL, MAC is a counselor, President and Founder of the National Institute for Holistic Addiction Studies and Chaplain of the North Miami Police Department. For the latest development in cutting-edge treatment check out his website: http://www.holisticaddictioninfo.com