NOTE: Dr. Romano demonstrates the conflict that arises when health care is a for-profit industry. The bottom line is profit and one way to make a profit is to create more demand for your product. This is another reason that we need a national health program that has health as the bottom line so that guidelines are written with the interests of patients in mind. – Dr. Margaret Flowers
By Max J. Romano for The Baltimore Sun
As a family physician in Baltimore, I use guidelines from professional groups to bring impartial scientific information to my clinical practice — or so I thought. When I read the new blood pressure guideline published by the American College of Cardiology (ACC) and the American Heart Association (AHA) in November, just five minutes of Internet searching exposed that six of the guideline’s authors had financial relationships with corporations that were not mentioned in the publication, as is generally required by the ACC, AHA and the medical journals in which the guideline was published.
These financial relationships between physician-scientists and for-profit companies make me doubt the new guideline, which recommends much broader diagnosis and treatment of hypertension (high blood pressure) and will likely benefit those corporations. And they should make patients doubt our whole profession.
The distinguished authors of the new guideline disclosed remarkably few “relationships with industry,” so I looked on cms.gov/openpayments — a public federal website that reports pharmaceutical and device-manufacturer payments to physicians — and I quickly found several concerning and undisclosed associations.
Robert Carey, vice chair of the guideline writing committee, was principal investigator for a study receiving $50,000 in research funding in 2014 from Daiichi Sankyo, which recently concluded a phase 3 trial in Japan for a hypertension drug called esaxerenone. He disclosed no relationship with Daiichi Sankyo despite previously serving on its medical advisory board.
Kenneth Jamerson, a member of the guideline writing committee, received $60,528 of “general payments” from Merck in 2013, including $28,552 for travel and lodging. Merck produces common hypertension drugs Cozaar, Hyzaar, and Prinivil. He disclosed no relationship with Merck.
Since 2013, other members of the writing group, including Samuel Gidding, Bruce Ovbiagele, Jeff Williamson, and Jackson Wright each received undisclosed payments of at least $1,000 (up to $68,529 for research) from corporations that will benefit from the expanded treatment of hypertension advocated by this guideline.
The guideline’s authors wrote in the Journal of the American Medical Association that the “guideline was developed over a 3-year period by a multidisciplinary team, including 2 lay participants, all of whom had no relationships with industry involving diagnosis or treatment of hypertension.”
Although I am unsure when each author began working on the guideline, the ACC and AHA required disclosure of all conflicts within 12 months of joining the writing committee, and the committee existed for at least three years, so presumably most relationships since 2013 should be disclosed. The American Academy of Family Physicians decided not to endorse this new guideline due to concerns about its scientific quality. I submitted letters to the editors of all the journals publishing this guideline, who unsurprisingly politely declined to publish them.
This guideline matters to my patients. When an elderly patient I’ll call Rose entered my office looking for a new primary care provider recently, she asked me which medicines were right for her. Rose had mildly elevated blood pressure, which the new ACC/AHA guideline classifies as “hypertension” and recommends treatment with blood pressure-lowering drugs that can cause dehydration, kidney damage, and fainting.
Rose was very frail, requiring near-complete dependence on her elderly husband for most activities of daily living liking eating, bathing and toileting. She had mild diabetes, so she injected insulin four times every day. She was incontinent of urine, so she took a bladder-relaxing prescription medicine. She had a distant history of arterial stents, so she took a daily blood thinner. The indiscriminate use of “guideline-based care” had already given Rose a litany of prescription drugs with marginal benefits in exchange for uncomfortable and dangerous side effects like low blood sugar, confusion and the possibility of dangerous bleeding.
For Rose, I did not recommend taking blood pressure medicine, and I actually stopped most of her other medicines that day due to concerning side effects. Although I violated several “guidelines,” I trust that I did what was best for her rather than what was best for the pharmaceutical industry.
“One of the first duties of the physician is to educate the masses not to take medicine” wrote the father of modern medical science, Sir William Osler. In our modern-day health care system, I suspect Osler would still argue that the key to better health might be less rather than more.
Dr. Max J. Romano is a resident physician in family and preventive medicine with MedStar Franklin Square Medical Center and Johns Hopkins Bloomberg School of Public Health; his email is firstname.lastname@example.org.
Correction: An earlier version of this article incorrectly stated that one of the authors had a financial relationship with Boston Scientific, which manufactures a device used in the treatment of hypertension.