conflicts of interest Archives - Lown Institute https://lowninstitute.org/tag/conflicts-of-interest/ Sun, 20 Feb 2022 20:12:52 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://lowninstitute.org/wp-content/uploads/2019/07/lown-icon-140x140.jpg conflicts of interest Archives - Lown Institute https://lowninstitute.org/tag/conflicts-of-interest/ 32 32 How some drug companies manipulate patient advocates https://lowninstitute.org/how-some-drug-companies-manipulate-patient-advocates/?utm_source=rss&utm_medium=rss&utm_campaign=how-some-drug-companies-manipulate-patient-advocates Sun, 20 Feb 2022 20:12:48 +0000 https://lowninstitute.org/?p=9902 Patient advocates and researchers uncover concerning patterns in financial relationships between industry funding and patient advocacy organizations.

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Over the past few years, more information has come to light on the financial relationships between the pharmaceutical industry and doctors — the connection between industry payments and opioid prescriptions, for example.

However, a more subtle but just as concerning pattern is the infiltration of pharma money into patient advocacy groups. A Kaiser Health News analysis found that drug companies gave 12,000 donations to patient advocacy groups in 2015, worth $116 million in total — nearly double what drug companies spent on lobbying that year.

What does pharma “grooming” look like?

How does this influx of industry funding impact the positions that patient advocacy groups take on issues of drug efficacy and affordability? This was the topic of discussion at a recent event by PharmedOut, a Georgetown University Medical Center project that educates health care professionals and students about pharmaceutical and medical device marketing practices (see the video recording of the event below).

Erin Little, a patient advocate from Ontario, CA who raises money for research on the rare disease cystinosis, shared her family’s story of being wooed by a drug company that was promoting a newer (and much more expensive) version of the drug her daughter was taking. She referred to the actions of the company as “grooming,” because parents of children with rare diseases are in a vulnerable position, desperate to keep their children alive. Pharma representatives used compliments, charm, and even tears to build an emotional connection with Little and other families of children with cystinosis.

“You can imagine the hope that filled my heart when a pharmaceutical rep stood up to talk about a magical drug,” recounted Little. “He cried and told us he loved our kids like his own. I was sobbing uncontrollably over the fact that someone out there cared about our children.”

The impact of advocacy-pharma relationships

Little and her organization remains free of pharma funding, but she is the exception, not the rule. This funding has a profound impact on the drug approval process, as testimony from patient advocates has become more common. The strong response from the Alzheimer’s Association after CMS’s decision not to cover Aduhelm is one recent example

Cindy Pearson, former executive director of the National Women’s Health Network, shared her experience watching patient advocate groups testify at FDA Advisory Committee meetings over the years. Even though many advocacy groups had been funded –and some likely coached– by drug or device companies, their testimony still had a strong impact of the advisory committee members. “What I remember very vividly is committee members saying, ‘I just don’t want to be mean…I want to be responsive,'” said Pearson.

What can we do about this? While disclosure of industry funding is imperative, it’s not enough, the experts said. Agencies that review evidence should be sure to invite more independent advocates, instead of just those funded by pharma. Patient advocacy groups should “just say no” to pharma funding, even so-called “unrestricted” grants.

“Once you’re getting money, you pretty well know that if you start criticizing the company, you’re not getting another grant,” said Sharon Batt, professor of bioethics at Dalhouse University in Nova Scotia, CA.

The limits of disclosure

A recent article in the journal Big Data and Society uncovers another important limitation of financial conflict disclosure. Researchers Shai Mulinari of Lund University in Sweden and Piotr Ozieranski at the University of Bath in the UK point out that the accessibility of information on industry payments to doctors through the Open Payments database may actually make it easier for industry to track how their funding to physicians is working and find new physicians to target for “key opinion leaders.”

For example, one marketing article suggested that marketers could use the Open Payments database to see whether target physicians are financially involved with other pharma companies, or to identify the most “sought-after” physicians with “star power.”

“While the Sunshine Act has clearly helped expose important commercial influences on both prescribing and the scale of industry involvement with physicians, it has also, paradoxically, fuelled further commercial surveillance and marketing,” Mulinari and Ozieranski write.

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Medical device industry spends more on physician payments than pharma https://lowninstitute.org/medical-device-industry-spends-more-on-physician-payments-than-pharma/?utm_source=rss&utm_medium=rss&utm_campaign=medical-device-industry-spends-more-on-physician-payments-than-pharma Sun, 25 Apr 2021 22:56:10 +0000 https://lowninstitute.org/?p=7992 A recent study finds that medical device companies spend more than pharma on payments to physicians, but spend it in different ways.

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Pharmaceutical company payments to physicians have received significant attention, as policymakers and patients are concerned with the impact of these payments on overprescribing of opioids and other potentially harmful medications.

But what about payments to doctors from companies that make medical devices? These conflicts of interest are less publicized, but are just impactful–if not more–than payments made by drug companies.

In a recent study in Health Affairs, Alon Bergman, postdoctoral fellow at the Leonard Davis Institute of Health Economics and the Wharton School at the University of Pennsylvania, and colleagues conducted a comprehensive examination of medical device industry payments across payment types and specialties. They found that the medical device industry is spending far more than pharma on payments to physicians, and these payments are targeted more specifically to physicians who use their products.

Between 2014-2017, device companies paid $904 million each year to physicians, compared to $821 million that pharma spent. That doesn’t seem like much more, but the device industry has a lot less revenue than pharma, so these payments represent a greater investment relative to the size of the industry. Device companies spent 1.7% of industry revenue on payments to physicians while pharma companies spent 0.24%.

Medical device companies spent more money overall but gave to fewer physicians than pharmaceutical companies did. Each year, about 30% of physicians received a payment from a device company, while about half of physicians received a payment from pharma. Device companies targeted neurosurgeons and orthopedic surgeons specifically; about 75% of physicians in these specialties received a payment. Physicians in surgical specialties typically received more than $400 annually from device companies, while physicians in other specialties received less than $50.

Within the surgical specialties, medical device companies appear to target physicians that do the greatest number of surgeries. The more a surgeon’s Medicare billing amount, the more they received from medical device companies. Surgeons in the 10% for Medicare billing received more than $10,000 from device companies, on average. Pharma also rewards high-billing physicians with greater payments, but even those in the top decile received $4,000 on average–less than half of what medical device companies pay their top physicians.

“The relatively steep relationship between device payments and billing suggests that device firms have greater potential scope than drug firms to influence spending on relevant patient populations,” the authors write. Previous research on the relationship between medical device company payments and physician decisions indicates that physicians are much more likely to use a device made by the manufacturer that gives them the largest payment.

“It becomes a lot harder to [decide which product is best] when that salesperson is also taking you out to $500 dinners and pays you tens of thousands of dollars in consulting fees over the last few years,” said Aaron Mitchell, oncologist and health services researcher at Memorial Sloan Kettering Cancer Research Center, in STAT.

Medical device industry payments differ from pharmaceutical industry payments in another key way: Medical device companies are paying physicians more for product development (categories of payments such as royalties, licensing, and investment) and education, while pharma companies are paying more for speaking fees and food and beverage costs. The authors propose that medical device vendors “may solicit input from practitioners on development, and physicians may approach vendors with ideas for devices,” especially because many medical devices do not have to go through clinical trials to be approved by the US Food and Drug Administration. The fact that new medical devices can go on the market with barely any testing leaves the field wide open for manufacturers and doctors to collaborate on new devices, although patient safety could suffer because of lack of regulation.

This groundbreaking study shows that payments to physicians from medical device company deserve just as much scrutiny as payments from drug companies, if not more. The specific nature of medical device usage means that targeting high-performing surgeons with big payouts could have a large impact on which devices get used the most. And these payments represent a high barrier to entry for new medical device companies that can’t afford to match them. These are areas in great need of more regulation, to prevent potential harm to patients from conflicts of interest.

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Covid-19 conflicts of interest go beyond pharma https://lowninstitute.org/covid-19-conflicts-of-interest-go-beyond-pharma/?utm_source=rss&utm_medium=rss&utm_campaign=covid-19-conflicts-of-interest-go-beyond-pharma Sun, 07 Mar 2021 20:31:53 +0000 https://lowninstitute.org/?p=7539 Dr. Vivek Murthy, Biden's pick for surgeon general, was recently found to have accepted significant consulting payments from private companies. Should this disqualify him from the position?

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At first glance, Dr. Vivek Murthy, President Biden’s pick for surgeon general, seems very qualified for the job. As surgeon general under President Obama, Murthy helped lead the national response to health crises like Ebola, Zika, and opioid addiction. He was part of Biden’s public health advisory committee in Spring 2020 and was co-chair of the Biden’s Covid-19 advisory board during his transition to president. He is also a strong advocate for expanding health care access; before joining the Obama administration, he founded the nonprofit organization Doctors for America.

However, new information uncovered from ethics documents have revealed conflicts of interest that some experts say should disqualify Murthy from being the leading spokesperson on public health.

Covid consulting conflicts

The Washington Post reported that Murthy was paid $2.6 million by various private companies for speaking and consulting since January 2020, which is “the most financial entanglements of any surgeon general pick in recent history,” according to the Post. Most notably, Murthy was paid $400,000 by Carnival Cruises, $600,000 by Netflix, and $800,000 (including stock shares) from Airbnb, for assisting these companies on Covid-19 safety practices.

Why are these conflicts of interest? Because the size of some of these payments suggest that private companies were not just paying Murthy for advice. Most of this consulting work came after Biden had basically secured the Democratic nomination, when Murthy was being identified as a Biden advisor in speeches, the Post reports.

“These companies aren’t paying exorbitant fees for advice or services provided…They are payments for influence,” writes Dr. Vinay Prasad, hematologist-oncologist and associate professor of medicine at the University of California San Francisco, in an op-ed in MedPage Today. Carnival, Netflix, and Airbnb all have a stake in the policies that the Biden administration enacts, such as ventilation standards on cruise ships, requirements for reopening film and tv sets, travel restrictions, etc. If Murthy is going to be a part of deciding when and how the country reopens, it is problematic for him to have these financial relationships.

“Payments of this magnitude inherently compromise Murthy’s ability to think only about what is best for the public. These conflicts should disqualify him from the post of Surgeon General,” writes Prasad.

The problem of the “revolving door”

Relationships between public employees and private companies have been a long-standing problem in government ethics. The phenomenon of government agency workers leaving to work in the industry they once regulated is so common, it has its own nickname: The “revolving door.”

A particularly flagrant example was in April 2019 when Demetra Ashley, the former acting assistant administrator of the U.S. Drug Enforcement Administration, became a paid consultant for Purdue Pharma, one of the largest opioid-makers in the U.S.

The problem with the revolving door is that officials may regulate less strictly or “play nice” with industry, either because they plan to go back to the private sector, or to increase their chance of getting an industry job in the future. Similarly, public sector officials who have worked for industry in the past may find it more difficult to be impartial when making decisions that their former partners have a stake in.

Conflicts of interest go both ways

When Scott Gottlieb was nominated for commissioner of the Food and Drug Administration in 2017, we noted that he had more financial conflicts than any previous FDA commissioner, and some Democratic senators spoke out on this topic as well. However, Democrats have been conspicuously silent about Murthy’s conflicts. At Murthy’s Senate committee confirmation hearing in late February, he was not questioned about his conflicts by the committee members.

Back in 2017, Murthy was lauded by doctors for standing his ground on public health issues that went against then-President Trump’s views, even when it resulted in his removal. Murthy was praised for avoiding the conflict of interest that can happen when public health figures who are supposed to be independent come under intense political pressure (which we saw happen with leaders of the FDA in 2020).

“We are often at the intersection of politics, ethics, and health and, when confronted by a conflict of interest, should act like Murthy,” wrote assistant professor of medicine at University of Alberta Dr. Hakique Virani in an op-ed in STAT in 2017.

While Murthy’s decision to stand his ground in 2017 despite losing his job was brave, we still have to hold him to the same standard. Avoiding one conflict of interest does not excuse others, regardless of what political side you are on.

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Is the Sunshine Act reducing conflicts of interest? https://lowninstitute.org/is-the-sunshine-act-reducing-conflicts-of-interest/?utm_source=rss&utm_medium=rss&utm_campaign=is-the-sunshine-act-reducing-conflicts-of-interest Thu, 11 Feb 2021 14:57:09 +0000 https://lowninstitute.org/?p=7216 A little over ten years after the Physician Payments Sunshine Act was passed, how have industry payments to physicians changed? A recent article in Medscape explores the impact of the legislation, obstacles to change, and potential solutions beyond just disclosure.

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A little over ten years after the Physician Payments Sunshine Act was passed, how have industry payments to physicians changed? A recent article in Medscape explores the impact of the legislation, obstacles to change, and potential solutions beyond just disclosure.

The Sunshine Act, which mandates that drug and device companies publicly report all the gifts and other payments they give to physicians, has certainly improved transparency. But that doesn’t necessarily mean that it’s changing behavior. A big reason why is that the onus is largely on patients to research their doctor’s conflicts, and many patients don’t have the time or interest to do that. “There is no doctor who’s going to say, ‘I was given this money from a company and that’s why I prescribed those drugs,'” said Lown Institute health policy and communications fellow Judith Garber, in Medscape.

While the disclosure of payments is helpful for those doing research on conflicts of interest, “It doesn’t seem like it’s causing change in the behavior of payments to physicians,” said Garber. An exception to the pattern is family practice, in which more residencies have become pharma-free over time, according to a recent study in the Journal of the American Board of Family Medicine.

Other experts quoted in the piece concurred that disclosure alone is not doing enough to curb conflicts of interest. We need more visibility of these payments (maybe signs at doctor’s offices that disclose how much they were paid by pharma) and more limits on payments from the government or other actors. “Disclosure is not the answer to this,” said Dr. Adam Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Massachusetts, and member of the Lown List of Independent Experts, in Medscape. “We’re not solving the problem. It’s a relationship that’s broken.”

For more, read the full piece in Medscape!

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Advocacy from independent experts reflected in new ob-gyn guideline https://lowninstitute.org/advocacy-from-independent-experts-reflected-in-new-ob-gyn-guideline/?utm_source=rss&utm_medium=rss&utm_campaign=advocacy-from-independent-experts-reflected-in-new-ob-gyn-guideline Fri, 05 Feb 2021 18:02:37 +0000 https://lowninstitute.org/?p=7049 A group of independent doctors spoke out in 2019 against what they saw as a potentially harmful recommendation that was influenced by financial conflicts of interest. Now it appears that the independent doctors' advocacy has helped to change that recommendation.

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A group of independent doctors spoke out in 2019 against what they saw as a potentially harmful recommendation that was influenced by financial conflicts of interest. The guideline advocated expanding the use of blood thinners for most women who had a cesarean birth, despite a lack of evidence to support this rule, leading to more women being given these medications unnecessarily.

Now it appears that the independent doctors’ advocacy has helped to change that practice. In August 2020, the Society for Maternal-Fetal Medicine and American College of Gynecology released their recommendations for blood thinners in women undergoing c-section. The new guideline acknowledges the lack of evidence behind broad use of blood thinners for all c-section patients, and instead recommends treating just higher-risk c-section patients with these medications.

“The fact that 46 of us stood against this pharma-funded approach may have helped bring evidence to this guideline,” said Dr. Adam Urato, Chief of Maternal-Fetal Medicine at the MetroWest Medical Center in Framingham, Massachusetts, who led the effort by independent doctors to speak out.

Jeanne Lenzer, investigative journalist and one of the creators of the List of Independent Experts, sees this new guideline as an example of what independent doctors can do when they advocate for patients. “This could be the beginning of a movement in which doctors from the international List of Industry-Independent Health Experts can come together to challenge clinical practice guidelines – most of which are compromised by financial conflicts of interest,” said Lenzer.

Blood thinners for all?

In 2016, the National Partnership for Maternal Safety (NPMS) released a list of recommendations for reducing deaths from blood clots in pregnant and postpartum women in the journal Obstetrics & Gynecology, popularly known as the “Green Journal.” One of these recommendations was expanding the use of blood thinners to most women after a cesarean birth. Since nearly one third of births in the US are by c-section, that’s about 1.3 million women a year who would be put on blood thinners after giving birth. This broad expansion of blood thinners was concerning to doctors who noted that this practice “is not justified by the available data and has the very real potential of doing more harm than good.”

Urato was also very concerned that the NPMS guidelines may have been influenced by industry connections. NPMS has significant has financial ties to industry companies, including three that manufacture or sell blood thinners. However, the 2016 recommendations did not include any of these conflict of interest disclosures from the NPMS. Urato reached out to doctors from the List of Independent Experts, and soon had a coalition of nearly fifty professionals. They wrote a letter to Obstetrics and Gynecology, which was published in November 2019, describing their concern both about the conflicts of interest and lack of disclosure of these conflicts in the journal. The letter also got the attention of major media outlets like the Wall Street Journal.

A new evidence-based guideline

In August 2020, the Society for Maternal-Fetal Medicine and American College of Gynecology released new recommendations on preventive thrombolytic treatment for women undergoing c-section. The guideline authors write that all women having a c-section should be given compression cuffs to stimulate blood flow, and those with a history of blood clots or family history of blood clots should receive blood thinners. But for women at low risk of blood clots, there is not enough evidence to support that they receive blood thinners, they write, reversing the recommendation from the NPMS.

The SMFM/ACOG document outlines the potential benefits and harms of giving all women blood thinners. The authors note that even among women at high risk of blood clots after surgery, 640 would need to take blood thinners to prevent one episode of venous thromboembolism (a dangerous blood clot that starts in the leg). At the same time, blood thinners can lead to the c-section wound separating and bleeding after the operation; one in 200 women to take blood thinners after c-section may be harmed.

While using compression cuffs to get the blood flowing is an inexpensive and safe intervention, the decision to use drugs to get the blood flowing is not as straightforward, and depends on the patient’s level of risk from blood clots. The SMFM/ACOG recommends that patients with a personal history of deep venous thrombosis or pulmonary embolism or family history of blood clots receive blood thinners, although they acknowledge that there is still not a high quality of evidence to support this recommendation.

Challenging industry influence in guidelines

Obstetrics is far from the only medical field in which industry conflicts may influence clinical practice guidelines. Evaluations of guidelines for gastroenterology, dermatology, oncology, and more find that the majority of guideline authors receive industry payments, and many receive payments in excess of $10,000.

“This dynamic is harmful to patients and the public because it often results in recommendations that put the profits of the drug companies above the health of patients and the public. There is a desperate need for clinical guidelines that are not influenced by corporate cash,” said Urato.

When it comes to clinical guidelines for cholesterol and heart health, financial conflicts of interest not only affect panelists’ interpretation of data, they “can also blind panel members to the fact that neither they nor the peer reviewers have been granted access to the underlying clinical trial data,” said John Abramson MD, MSc, Lecturer in the Department of Health Care Policy at Harvard Medical School. “Without seeing the underlying trial data, guideline panel members are not able to ensure that the analyses they are integrating into their guidelines are accurate and complete.”

“The IOM/NAM recommends that no members of guideline panels have conflicts of interest (and certainly not a majority), and no chairs or vice chairs have conflicts of interest. But both of these recommendations are routinely violated, and this is highly likely to bias the guidelines in favor of the manufacturers,” said Abramson. “Independent physicians could bring attention to these violations.”

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The cardiac implant you get may depend on the company paying your doctor https://lowninstitute.org/the-cardiac-implant-you-get-may-depend-on-the-company-paying-your-doctor/?utm_source=rss&utm_medium=rss&utm_campaign=the-cardiac-implant-you-get-may-depend-on-the-company-paying-your-doctor Fri, 13 Nov 2020 17:15:49 +0000 https://lowninstitute.org/?p=6446 Does receiving money from medical device companies impact the devices doctors implant in patients? A recent study in JAMA suggests that it does.

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We’ve written about drug company payments to doctors and the effect this has on prescribing habits. But what about payments from medical device companies? Does receiving money from medical device companies impact the devices doctors implant in patients? A recent study in JAMA suggests that it does.

In this study, researchers looked at a sample of 145,900 patients who received either an implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator device. These are devices for patients with heart failure, which are designed to prevent life-threatening arrhythmias (abnormal heart rhythms) by giving a small “shock” to the heart when necessary.

Of the 4,435 physicians who implanted these devices from 2016-2018, 94% of them received some payment from device manufacturers. The majority of doctors (75%) received payments from 3 or 4 manufacturers; only 8% received payments from just one manufacturer. The vast majority of payments (88%) amounted to $10,000 or less, but some payments were as high as $320,000.

Physicians were much more likely to use the device made by the manufacturer that gave them the largest payment than any of the other manufacturers. Overall, 47% of patients received a device from the manufacturer that gave their physician the most money. For physicians that received more than $25,000 annually, 51.1% to 59.5% of patients received a cardiac device from the manufacturers that provided the largest payment.

Physicians were also more likely to use the device from the manufacturer that paid the second-most, compared to manufacturers that paid less. One of the device makers (known in the study only as “Manufacturer B”) appeared to be the most generous spender. Among the doctors that got the most from Manufacturer B, 74% of the total payment was from this device maker. And among the doctors that got the most from the three other device makers, Manufacturer B’s payments made up the next-largest proportion of their total payments. This may have had an effect on which devices doctors used; in total, 40% of all the devices implanted were from Manufacturer B.

Another interesting finding from the study was a comparison between physicians who had not received any payments and physicians who did. Doctors who did not receive payments were less likely to be giving patients a device for primary prevention (to stop a first cardiac event) as opposed to secondary prevention (prevent another cardiac event). Among doctors who did not receive payments, 75.9% of patients were given a device for primary prevention, compared to 78.3% of the patients in the total sample. These doctors were also more likely to give patients a single-chamber ICD as opposed to a dual chamber ICD or CRT-D. While these differences were slight, they may indicate that doctors receiving payments have a bias toward implanting more expensive devices for patients who may not need them.

In the study, there was no difference in rate of complications or death depending on whether or how much a physician was paid. So why do these payments matter? In an accompanying editorial, Harvard Law professor Carmel Shachar and JAMA Deputy Editor Dr. Gregory Curfman point out that payments to doctors from drug companies raise the price of devices. “The payments to physicians…were funded by ICD sales, and these devices would be less expensive without these payments,” they write.

Shachar and Curfman also note that “these payments may undermine the reputation and trust of the medical profession, potentially damaging the complex relationship between patients and physicians.” If patients knew how much their doctor’s (conscious or unconscious) decision was potentially affected on the amount they were paid by medical device companies, this could certainly reduce trust in the medical profession– trust that we need now more than ever.

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Conflicts running rampant in the Covid era https://lowninstitute.org/conflicts-running-rampant-in-the-covid-era/?utm_source=rss&utm_medium=rss&utm_campaign=conflicts-running-rampant-in-the-covid-era Mon, 10 Aug 2020 20:02:49 +0000 https://lowninstitute.org/?p=5738 As our country faces difficult decisions about how to mitigate the pandemic, pharmaceutical companies are wielding their influence through contributions to policymakers, health care administrators, and journalists.

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As our country faces difficult decisions about how to mitigate the Covid-19 pandemic, pharmaceutical companies are wielding their influence through considerable contributions to policymakers, health care administrators, and journalists. These conflicts contribute to media hype of new treatments and propagation of the idea that lower prices threaten innovation.

Campaign contributions abound

Let’s start with the big picture. According to a recent analysis in StatNews, more than two-thirds of sitting members of Congress have received contributions from pharmaceutical companies in advance of the November 2020 election. This includes payments from Covid-19 vaccine developers AstraZeneca ($314,500 paid to politicians), Johnson & Johnson ($542,000), and GlaxoSmithKline ($195,000), as well as remdesivir drug developer Gilead ($174,000).

These contributions are partly for “greasing the skids on a particular issue for which a company has great concern or sees great opportunity,” like Covid-19, said Sheila Krumholz, the executive director of the Center for Responsive Politics.

Altogether, the 25 largest drug companies and trade groups spent $11 million on 2020 campaign contributions. Although the contributions favored Republican incumbents, Democrat politicians still received about 47% of these contributions from drug companies.

“The breadth of these contributions shows drug corporations have no intention of doing anything to lower their prices.”

Ben Wakana

“The breadth of these contributions shows drug corporations have no intention of doing anything to lower their prices — they are lavishing millions in campaign contributions to protect their power to dictate high prices for prescription drugs,” said Ben Wakana, the executive director of the advocacy group Patients for Affordable Drugs Now.

Hospital CEO’s conflicts go undisclosed

In early February, Betsy Nabel wrote in a syndicated op-ed that lowering drug prices would harm the “innovation ecosystem” and curtail drug development. We’ve seen this argument used many times before, but this was one of the few times a hospital CEO had made this point, giving the “innovation” claim more weight.

Nabel’s byline identified her as a “cardiologist, a professor or medicine at Harvard Medical School and the president of Brigham Health and its Brigham and Women’s Hospital.” But she did not disclose that she was a member of the board at the biotech company Moderna until very recently, the Boston Globe reported. As a member of the board, Nabel received $487,500 in stock options last year, and owned millions of dollars in company stock.

As a member of the board, Nabel received $487,500 in stock options last year, and owned millions of dollars in company stock.

In the op-ed, Nabel wrote that policies such as drug price controls “could eliminate the financial incentives that allow research scientists to explore new treatments.” Coming from an independent doctor and researcher with decades of experience, this claim holds some weight; from a Moderna board member with a fiduciary duty to the drug company, the argument is much less convincing. Writers at the Globe noted that Moderna plans to price their vaccine at a much higher level compared to other companies, casting further suspicion on Nabel’s insistence on higher prices for the sake of “innovation.”

Who is funding journalism training?

Gary Schwitzer, journalist and creator of Health News Review, found several recent examples of drug companies funding training for journalists. One of these cases is a Vaccine “Boot Camp” event series, funded by GlaxoSmithKline, a drug company with a Covid-19 vaccine currently in development, and run by the National Press Foundation, which has previously taken money from drug companies to run journalism trainings.

Schwitzer notes the irony of GSK funding a journalism training on vaccines, while former GSK executive Moncef Slaoui is leading the President’s vaccine initiative called Operation Warp Speed. Slaoui’s numerous financial conflicts of interest have been previously criticized by the press. So if you can’t beat them…fund them? The whole thing just “doesn’t smell right,” writes Schwitzer.

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Pharma sales reps still visiting doctors in the pandemic https://lowninstitute.org/pharma-sales-reps-still-visiting-doctors-in-the-pandemic/?utm_source=rss&utm_medium=rss&utm_campaign=pharma-sales-reps-still-visiting-doctors-in-the-pandemic Sun, 14 Jun 2020 21:47:52 +0000 https://lowninstitute.org/?p=4851 Visits from pharmaceutical sales reps haven't stopped during the pandemic--they've just moved online...

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One might expect that visits from pharmaceutical sales reps would cease during the Covid-19 pandemic, given that hospitals and clinics have largely shut down in-person non-emergency services. But as it turns out, sales rep visits haven’t stopped–they’ve just moved online.

According to a poll conducted last month by health care consultancy company ZoomRx, about 80% of physicians said they would like some degree of contact with pharmaceutical sales reps during the pandemic. Fourteen percent of doctors said they wanted more outreach from pharma compared to before the pandemic began. Why this need for sales rep visits in this health emergency?

Doctors may want to know more about whether certain drugs are safe to take for patients that have Covid-19. Or they might be trying to secure their supply of free samples for low-income patients. But there could be another, more worrisome reason behind this trend: camaraderie. A large part of the job of sales reps is to become friendly with doctors, to learn as much as possible about them and gain their trust, so eventually their “friendship” is repaid with more prescriptions.

Aaron Kesselheim, professor of medicine at Harvard Medical School, speculated that pharma reps’ “ability to influence physicians will diminish because of the much more impersonal nature of virtual interactions,” in The Wall Street Journal. However, in this time of uncertainty and loneliness, some doctors’ relationships with pharma reps could actually become stronger. One doctor responded in the Zoom Rx poll, “During the Covid-19 pandemic, it’s actually been nice to have appointments to talk to the representatives over my lunch hour.”

Another reason why doctors may still want to see pharma reps is because it can lead to more business opportunities. Doctors may be invited to give travel, give talks, and be a “thought leader” for the company, which is quite lucrative. However, these relationships are often problematic, especially for doctors that hold leadership positions in professional medical organizations.

According to a recent study in The BMJ, 235 out of 328 leaders of 10 professional medical organizations (72%) had financial ties to industry in the years 2017-2019. These were not just small payments either; the median payment amount was $31,805. Payments to leaders of the American Society of Clinical Oncology were the largest, with a median leader payment of $518,000, while leaders of the American Psychiatric Association got a median payment of $212.

A large body of research shows that receiving money from pharma reps impacts doctors’ prescribing habits. As pharmaceutical companies look at the pandemic as a potential opportunity to increase their contact with doctors, policymakers should work toward reducing the prevalence of these relationships.

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How bad science sows doubt https://lowninstitute.org/how-bad-science-sows-doubt/?utm_source=rss&utm_medium=rss&utm_campaign=how-bad-science-sows-doubt Tue, 03 Mar 2020 14:29:54 +0000 https://lowninstitute.org/?p=3532 In a new book, former OSHA director David Michaels reveals how some industries use bad science to "manufacture uncertainty" about the harms of their products.

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What do tobacco, diesel engines, football, and talc all have in common? The industries that make and sell these products have all conducted elaborate campaigns to “manufacture uncertainty” about the harms they cause. And they do it with the help of scientists for hire.

In his recently published book, The Triumph of Doubt: Dark Money and the Science of Deception, Dr. David Michaels, epidemiologist and former head of the Occupational Safety and Health Administration (OSHA), outlines how numerous industries employ “product defense firms” to ward off regulation and lawsuits. These firms produce “evidence” that these products are not as dangerous as previous studies show, using a combination of bad science, sneaky statistics tricks, and plain old lies.

Here are a few ways that industries and product defense firms bend the data and secretly influence environmental and public health policy:

  1. To increase doubt about the evidence surrounding a product, conduct a literature review that includes both independent and conflicted research. Even if there are more studies that make a product look bad, the biased studies will provide a counterweight, adding to the “uncertainty” in the evidence base.
  2. If a study shows that a product is dangerous, do a “re-analysis” using a different research design that finds a new result. With epidemiological studies, changing certain variables until you get the result you want (often known as “p-hacking”) is easy to do. Scientists know that these re-analyzed studies are unreliable, but the public may not, especially if the “new” study is aggressively publicized.
  3. To hide the funding sources behind new research on industry products, create a front group with an academic-sounding name, like the Alcohol Beverage Medical Research Foundation (created by beer and malt beverage producers) or the Mining Awareness Research Group (created by the diesel industry)
  4. If evidence shows that a product is dangerous, change the narrative. Create studies to prove that it is only dangerous is large quantities and that “moderate” use or exposure is fine. This is what the alcohol industry tried to do by funding a National Institutes of Health study to show that moderate alcohol use has cardiovascular health benefits.
  5. Claim that scientists conducting research about a product are “independent” because they are not directly paid by industry, even when they are hired by product defense firms that are paid by industry.
  6. When faced with evidence that a product is dangerous, shift the burden of proof from industry to regulators. Demand “proof beyond a shadow of a doubt” that the product is dangerous, as if the regulatory process is a criminal trial. This is what Johnson & Johnson did to avoid regulation of talc as a carcinogen, despite mounting evidence that talc is linked to ovarian cancer.

To help make our food, environment, and homes safer, we need to address conflicted parties that use the mantle of “science” to defend industry. Michaels suggests adopting the World Health Organization’s policy of not allowing conflicted scientists to write reports about exposures or issue regulations or vote in the panels’ conclusions. All conflicts of interest, especially those hiding behind many layers of funding, must be uncovered or disclosed. This would be the least we could do.

Michaels urges other broader changes in regulation, such as requiring proof of safety for chemicals before allowing them, rather than our current policy of assuming that chemicals are “innocent until proven guilty.” Even more importantly, while science is necessary for understanding the effects of certain products, change will not happen with science alone– organizing for change is key.

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Upcoming conflict of interest conference funded by…pharma?! https://lowninstitute.org/upcoming-conflict-of-interest-conference-funded-by-pharma/?utm_source=rss&utm_medium=rss&utm_campaign=upcoming-conflict-of-interest-conference-funded-by-pharma Thu, 27 Feb 2020 18:47:04 +0000 https://lowninstitute.org/?p=3537 A conference on conflicts of interest would be a great event...if it weren't funded by industry.

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Financial conflicts of interest in health care are rampant. In 2015, almost half (48%) of all doctors in the US received some kind of payment from the drug or medical device industry. Over the past five years, more than 700 doctors received a million dollars or more from industry. Financial conflicts affect doctor prescribing habits, the creation of clinical practice guidelines, the policy positions of patient advocacy groups, how health news is reported, and more. It is not an overstatement to say that drug and device industry funding influences every aspect of the health care system.

In the midst of this epidemic of financial conflicts, a meeting to discuss this issue frankly would be welcome. So when the NYU Grossman School of Medicine announced their upcoming conference on conflicts of interest in health care, featuring several well-known outspoken clinician speakers, it seemed like the perfect opportunity to translate research on conflicts into action.

But there’s one big problem: The conference is sponsored by Johnson & Johnson, a huge manufacturer of both medical devices and pharmaceuticals. Additionally, Sandra Morris, J&J’s vice president of strategy realization, is on the organizing committee for the event.

The irony of a conflict of interest conference being funded and co-organized by industry has not gone unnoticed. “This is a conflict of interest conference with a conflict of interest,” said Dr. Adriane Fugh-Berman, professor at Georgetown University and director of the PharmedOut project, in an interview with STAT News. “It should be antithetical to their purpose to accept industry funding in order to discuss a topic of such major financial importance to that industry.”

Why have industry at the meeting? Dr. Arthur Caplan, one of the meeting organizers and head of the Division of Medical Ethics at the New York University Langone Medical Center, said that having a variety of views on conflicts makes for a more exciting and fruitful discussion. “My view is to invite a lot of parties and let them go at it,” he said, in STAT.

However, there is big difference between inviting an industry representative to be on a panel at a conference and having industry underwrite and organize the conference. You don’t need to put industry at the wheel of the whole event to “include” them.

By putting J&J in charge, NYU is giving them a wide open opportunity to push the idea that it’s not only financial conflicts of interest that are bad, but also ideological conflicts of interest. Industry would like people to believe that having an “intellectual bias” is just as harmful as receiving money from industry. The conference organizers seem to support this reframing. According to STAT, the conference invitation to potential panelists read that “all participants are susceptible to financial or ideological conflict of interest.”

This narrative that having preconceived ideas about a topic is on par with a financial relationship with industry is dangerous for many reasons. First, it paints conflicts of interest as too complex to solve (how can you root out all “intellectual bias?”). Second, it provides a base for industry to try to change laws around conflicts of interest to equate “intellectual” conflicts with financial ones, which would make financial conflicts nearly impossible to regulate.

As Upton Sinclair famously said, “It is difficult to get a man to understand something when his salary depends upon his not understanding it.” Until these types of events are free from industry funding, the organizers will fail to understand the depth of harm that financial conflicts of interest cause in health care.

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