Lessons from Corporate Influence in the Opioid Epidemic: Toward a Norm of Separation

There is overwhelming evidence, writes Jonathan Marks in Bioethical Inquiry,  that the opioid crisis—which has cost hundreds of thousands of lives and trillions of dollars (and counting)—has been created or exacerbated by webs of influence woven by several pharmaceutical companies. Opioid companies built these webs of health professionals, patient advocacy groups, medical professional societies, research universities, and others as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups of patients with acute or chronic pain. Governments, the academy, and civil society need to develop counterstrategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift—from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation.

Addressing Commercial Determinants of Health Begins with Clearer Definition and Measurement

In an editorial in Global Health Promotion, Kelley Lee and Nicholas Freudenberg call for a clearer and more precise definition of “commercial determinants of health” and new approaches to assessing its influence on the global distribution of health and diseases. Such an approach, they argue, will lead to better understanding of the complex pathways between commercial determinants of health and non-communicable diseases (NCDs), now the leading cause of the global burden of disease and a key driver of health inequities. It will also provide evidence that can expand public health interventions from their current focus on individual and behavioral risk factors to the systemic and structural influences on NCD prevalence and distribution.

Commercial Influence and COVID-19

In an editorial in BMJ, Ray Moynihan and colleagues describe some of the ways that commercial actors have influenced assessment of the antiviral remdesivir and the heavy involvement of  Gilead, the maker of the drug, in designing the trials and  promoting the findings of its studies before peer review. Remdesivir is used to treat COVID-19 and Gilead will reportedly charge more than $3,100 to treat a typical COVID-19 patient with private health insurance.

The authors also cite a Call to Action circulated by BMJ calling for more independence from commercial influences in medical research, practice and education.  Almost 500 health professionals from around the world have already signed. 

Beyond the Sacklers: Free-trade policies contributed to the opioid epidemic

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In a commentary in STAT and a scientific report in SSM-Population Health, Adam Dean and Simeon Kimmel explore the connections between the opioid epidemic and free trade agreements.  They argue that the trade crisis and the opioid crisis feed on each other. Economists have explained how free trade lowers wages and employment levels for less-educated manufacturing workers in the U.S. Relatively good jobs with high wages and benefits are disappearing, while factory closings damage the social fabric of their surrounding communities.

Continue reading Beyond the Sacklers: Free-trade policies contributed to the opioid epidemic

Cities vs. Big Pharma: Municipal Affirmative Litigation and the Opioid Crisis

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The opioid crisis has been called the worst drug epidemic in American history, writes Nino Monea in the Urban Law Journal. It has already killed thousands and scarred millions more. Over the last few years, there has been a rise in affirmative litigation by municipalities, proactive suits that seek to vindicate some public interest, not merely the municipality’s corporate interests. This article examines the recent wave of lawsuits by cities and counties against the opioid industry. 

Continue reading Cities vs. Big Pharma: Municipal Affirmative Litigation and the Opioid Crisis

In Runup to 2020 election, Renewed Action to Regulate the Pharmaceutical Industry

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Overt the last several years, the pharmaceutical industry has been accused of inappropriately and misleadingly advertising prescription drugs to consumers, charging exorbitant prices, paying competitors not to release less expensive generic drugs, and negotiating trade agreements that benefit the industry at the expense of the public.   As public concern about these practices grows and as the 2020 election gets closer, Big Pharma is getting closer scrutiny.

A few recent actions illustrate this new climate. Earlier this month, reports The New York Times, the Trump administration announced that  for the first time will, it will require pharmaceutical companies to include the price of prescription drugs in television advertisements if the cost exceeds $35 per month.  The move is the most visible action the administration has taken so far to address the rising cost of prescription drugs. It has been a key issue for American voters and one that both Republicans and Democrats have vowed to address.

In Congress, Reps. Judy Chu (CA-27) and Devin Nunes (CA-22) last month  introduced the Sunshine for Samples Act of 2019. This bill would amend the Sunshine Act, which requires pharma companies to report payments to doctors,  to require companies that manufacture drugs, devices, biologics, or medical supplies to publicly make available the number and value of free drug samples given to health care providers and charities each year. The bill closes a loophole in the Sunshine Act and does not prevent drug and device manufacturers from continuing to provide free samples, nor does it add any new burdens to providers under the Open Payment Programs.

Both the Federal Trade Commission and Congress have also acted to oppose “pay for delay” a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines. These drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market.  Last month , Congressman Jerrold Nadler introduced H. R. 2375 , the Preserve Access to Affordable Generics and Biosimilars Act. The bill proposes to prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

These recent actions suggest that the 2020 election will provide public health professionals and advocates with opportunities to educate the American people and elected officials about the practices of the pharmaceutical industry and to counteract pharma’s extensive spending to influence Congress.

 

 

As more museums say no to Sackler donations, family trust halts its giving

In another story, The Washington Post writes that facing rejection from three major art museums, the philanthropic trust of the Sackler family, which built its wealth from Purdue’s  sale of opioids, announced that it would stop making donations. “I remain fully committed to all the causes the Sackler Trust supports, but at this moment it is the better course for the trust to halt all new giving until we can be confident that it will not be a distraction for institutions that are applying for grants,” Theresa Sackler, chairwoman of the trust, said in a statement on its website. The decision by many nonprofits to stop accepting Sackler donations may contribute to a de-normalization of the marketing practices of big pharmaceutical companies, a change that could set the stage for stronger public health regulation of these practices.

Causes, Consequences, and Control of High Cancer Drug Prices

We have seen a sharp increase in cancer drug prices in recent years, far exceeding the rates of inflation, writes Bishal Gyawaliin a chapter in a new book Cancer and Society. This increasing cost of cancer drugs has many adverse consequences not only for the economy of the country but also in clinical outcomes of cancer patients, a phenomenon referred to as “financial toxicity,” Indeed, the increasing cost of cancer drugs is no longer just a policy issue; it is also a clinical issue with clinical consequences such as increased risk of mortality, poor quality of life, and lack of adherence to medications among others. The author explores the causes and consequences of high cancer drug prices in detail and explores different strategies that have been proposed to control these costs.

Gyawali B. Causes, Consequences, and Control of High Cancer Drug Prices. In Cancer and Society 2019 (pp. 39-57). Springer, Cham.

Obstetrician-Gynecologists and Industry Let the Sunshine In!

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“What is an ethically responsible relationships between obstetrician-gynecologists(ob-gyns) and the pharmaceutical and medical device industries”, asks Lewis Wall in an editorial in Obstetrics & Gynecology?  He notes the inherent conflicts between the worldview of the pharmaceutical-medical device industry, where pursuit of profit overrides all other considerations, and the overriding obligation of physicians to put the health interests of their patients first.  When the trust that obligation engenders is lost, he writes “medical practice breaks down.”

Industry Payments to Obstetricians and Gynecologists Under the Sunshine Act

Another article in Obstetrics & Gynecology examines industry payments to ob-gyns. To evaluate financial relationships between obstetrician–gynecologists (ob-gyns) and industry, including the prevalence, magnitude, and the nature of payments, the authors of this report conducted a cross-sectional study using a list of industry contributions to U.S. obstetricians and gynecologists obtained through the Centers for Medicare and Medicaid Services Open Payments Database from August 1, 2013, to December 31, 2015. They concluded that obstetricians and gynecologists receive a substantial amount of payments from industry. Most of these payments were for honoraria, faculty compensation, or consulting and totaled less than $400 per health care provider. Although this total amount is less than typically received by surgical providers, the median payment value for obstetrics and gynecology subspecialists surpasses the median payment to orthopedic surgeons, the highest compensated specialty group in total. These financial relationships warrant further exploration with future research.

Addressing Generic-Drug Market Failures — The Case for Establishing a Nonprofit Manufacturer

Robust competition usually keeps the price of generic drugs well below that of brand-name drugs. When there is little or no competition, however, generic-drug manufacturers can substantially increase prices, and drug shortages may occur. Such market failures can compromise care and negatively affect patients, health care providers, government insurance programs, and private health plans. We believe that market-based solutions are an important alternative approach to stimulating competition in generic-drug markets. One such solution is to establish a nonprofit generic-drug manufacturer with the explicit mission of producing affordable versions of essential drugs and ensuring a stable supply of such products. A consortium of hospitals and health plans, including Intermountain Healthcare, Trinity Health, SSM Health, and Ascension, in collaboration with the Department of Veterans Affairs and philanthropists, is following this approach and developing a nonprofit generic-drug manufacturer code-named Project Rx. Citation: Liljenquist D, Bai G, Anderson GF. Addressing Generic-Drug Market Failures -The Case for Establishing a Nonprofit Manufacturer. N Engl J Med. 2018;378 (20):1857-1859.