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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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.”

The post Advocacy from independent experts reflected in new ob-gyn guideline appeared first on Lown Institute.

However, the NPMS did not include disclosure of their financial ties to pharmaceutical companies that manufacture blood thinners. It took three years for Obstetrics and Gynecology to publish a correction, which noted that NPMS receives industry funding from three companies that manufacture or sell blood thinners, but did not include the names of these companies.

As doctors noted in an accompanying editorial, the broad expansion of blood thinners to all women who have a c-section “is not justified by the available data and has the very real potential of doing more harm than good.”

A few months ago, we called attention to these conflicts of interest and the doctors who are pushing back, such as Dr. Adam Urato, Chief of Maternal-Fetal Medicine at the MetroWest Medical Center in Framingham, Massachusetts. “We really need public attention on this issue and we need to make sure that this type of industry influence is not allowed to be hidden and go unchecked,” said Urato. 

Why industry-independent experts are essential

When Urato uncovered this conflict in the NPMS recommendations, he reached out to investigative journalist and author Jeanne Lenzer and Lown Vice President Shannon Brownlee to help him spread the word. About ten years ago, Lenzer and Brownlee created a List of Industry-Independent Experts, to help health journalists find sources, like Urato, that aren’t biased by financial ties to industry.

Soon, Gary Schwitzer, journalist and founder of Health News Review, and Adriane Fugh-Berman, Georgetown professor and director of PharmedOut, joined the effort to help grow and disseminate the List. Currently, the List has over 100 sources and is still growing.

Brownlee and Lenzer helped Urato quickly recruit dozens of clinicians from the List to serve as signatories for the letter to Obstetrics & Gynecology. Being able to reach non-conflicted experts is extremely valuable, not only for journalists looking for sources, but for clinicians and patient advocates trying to take action against financial conflicts of interest in medicine.

The letter of protest

Urato and about fifty other doctors made sure these conflicts of interest did not go undetected. They wrote a letter to Obstetrics and Gynecology, which was just published in the journal. In their letter, they write of their concern that the conflicts of interest were not disclosed when the recommendations were originally published, and the companies were not explicitly named in the journal’s correction published three years later.

Urato and colleagues write that NPMS receives funding from “Abbvie, Allergan, AMAG Pharmaceuticals, Bayer Health Care, Ferring Pharmaceuticals, Hologic, Illumina, Johnson & Johnson, Masimo, Myriad, Pfizer, Premier, and Salus Global.” Among these companies, three manufacture anticoagulants. The doctors express concern “radical approach” recommended by the NPMS to prescribe anticoagulants to all large numbers of women has risks that are “unknown but could be considerable.” They also note that there are other non-pharmacological methods of reducing blood pressure that could have been recommended first.

Fortunately, this important issue is starting to pick up steam. The Wall Street Journal recently covered the issue and spoke with the companies that fund the NPMS. Johnson & Johnson, Bayer AG, and Pfizer, Inc all confirmed their financial support for NPMS, but insisted they had no input on the recommendations. However, these financial ties may still influence the organizations recommendations, because NPMS knows that industry money will continue to flow if they recommend broader use of medications.

Research on conflicts of interest has shown that financial support from industry organizations influences clinical practice guidelines, regardless of whether the company has direct input on guideline content. For example, one study compared industry payments for the authors of two different stroke guidelines, and found 35% of doctors who recommended an unproven drug treatment for stroke were being paid by industry, compared to 0% of doctors who did not recommend this treatment.

It is encouraging to see doctors taking a stand against industry influence in medical guidelines and recommendations. The NPMS recommendation has already affected millions of women, and will create unknown risks for millions more in coming years. With the work of industry-independent clinicians, and the help of a network to connect them, we can continue to put pressure on clinician groups to disclose—and hopefully eliminate—their financial conflicts.

The post Doctors speak out on conflicts of interest in obstetrics appeared first on Lown Institute.

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. 

“It’s an uncontrolled experiment on women who just have a baby” — Shannon Brownlee

Researchers responded to this recommendation with alarm. In an accompanying editorial in Obstetrics and Gynecology, two obstetricians warned that the broad expansion of blood thinners to all women who have a c-section “is not justified by the available data and has the very real potential of doing more harm than good.” Given the rate of blood clots in new mothers, approximately 1 million women would require blood thinners to prevent even one maternal death from cesarean delivery–associated pulmonary embolism, the authors wrote. Abiding by this recommendation would cost as much as $130,000,000 and expose thousands of women to the risk of severe bleeding and other side effects. 

“It’s an uncontrolled experiment on women who just have a baby,” said Shannon Brownlee, Lown Institute Senior Vice President, about the NPMS recommendation.

Since 2016, some obstetricians have noticed a difference in the number of pregnant and postpartum women who are being placed on blood thinners. One of these physicians is Dr. Adam Urato, Chief of Maternal-Fetal Medicine at the MetroWest Medical Center in Framingham, Massachusetts. “Over the last few years, we have seen this real ‘push’ to get pregnant women on blood thinners,” said Urato.

“Over the last few years, we have seen this real ‘push’ to get pregnant women on blood thinners.”

Urato was concerned by increasing pressure at his institution to adopt the NPMS recommendations on blood thinners, and decided to look deeper into the organization. What he found was that NPMS has significant has financial ties to industry companies including Abbvie, Allergan, AMAG Pharmaceuticals, Bayer Health Care, Ferring Pharmaceuticals, Hologic, Illumina, Johnson and Johnson, Masimo, Myriad, Pfizer, Premier, and Salus Global, through their “Industry Forum.” However, the 2016 recommendations did not include any of these conflict of interest disclosures from the NPMS.   

“It astounds me that the National Partnership for Maternal Safety submitted this article to the Green Journal without disclosing these industry ties,” said Urato. Urato notes that Obstetrics and Gynecology elicits potential conflicts of interest several times in their submission process, making the omission of these conflicts even more outrageous.

It took three years for Obstetrics and Gynecology to publish a correction, which noted that NPMS receives industry funding from three companies that manufacture or sell blood thinners. This correction appeared in the print version of the journal only, not the online version, making it even more difficult to find. Additionally, none of the names of the corporations that are linked to NPMS are mentioned in the disclosure. “This isn’t a transparent disclosure statement,” said Urato. “I give the journal credit for running the correction, but the way it was handled was a little bizarre.”

Urato and a group of obstetricians wrote a letter to Obstetrics and Gynecology, demanding a thorough investigation into why the conflicts were not disclosed, and, more importantly, a plan of action for how to prevent this from happening again. The letter has now been signed by more than forty physicians, researchers, nurses, lawyers, journalists, and others from around the world, and is currently under review at the journal.

“We really need public attention on this issue and we need to make sure that this type of industry influence is not allowed to be hidden and go unchecked,” said Urato. 

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