The anticoagulant standard of care nobody tested

In 1997, the LA Times published my article titled “Good Medicine, Fewer Hospital Beds.” Writing as an attending internist at a large public teaching hospital, I criticized a decision to spend $900 million on a massive 600-bed replacement facility. My experience affirmed what federal, state, and county analysts already knew: Resources were poured disproportionately into expensive acute inpatient specialty services, leaving primary care and out-of-hospital services for millions of medically indigent and Medi-Cal patients systematically underfunded.

This article effectively outed me as a whistleblower. I had previously criticized the administration for shutting down my pain, palliative care, and hospice consultation service in 1995 when the institution faced a financial crisis. I also spoke out against systemic inefficiencies: unacceptable wait times for imaging, delayed social work evaluations for discharge, and backlogs for specialist consultations. At the time, low-income Medi-Cal patients could choose between our facility and a local HMO hospital. The average length of stay at our facility was roughly 50 percent longer. Our public facility was incentivized by a flat per-diem reimbursement rate, whereas the HMO had every incentive to expedite treatment and safely discharge patients.

Within three months after the LA Times article appeared, I was charged with eight malpractice allegations. None were substantiated, and none were used in court, and I had no such allegations in the previous 17 years. I believe the timing was not a coincidence. About three months after the op-ed, I was charged with medical malpractice for stopping the anticoagulants heparin and warfarin in a man with deep venous thrombosis in his legs, alcoholism, liver cirrhosis, an elevated protime test, indicating compromised liver function, and active pulmonary tuberculosis. Because of this high bleeding risk, I stopped the anticoagulants while he was in the hospital. He died of pulmonary emboli about a week later. I felt very sorry for him and his family.

In preparation for the administrative law hearing to keep my medical license, I found a very shocking medical journal article. In a randomized controlled trial of heparin and warfarin versus phenylbutazone (anti-inflammatory pain medication), out of 60 patients taking phenylbutazone, none died, versus 2 deaths out of 66 patients taking heparin and warfarin. I could find no data in the literature supporting heparin and warfarin for the treatment of deep venous thrombosis. Yet it was the standard of care that I and other physicians have routinely used for decades. I pointed this out in the administrative law hearing and the prosecuting attorney objected. The judge sustained the objection. At the end of the trial, the judge asked me if I had it to do over again, would I stop the anticoagulants. I said that, based on the randomized trial I found, I would. The judge took away my medical license for that single case. That began my 26-year campaign to stop unnecessary bleeding deaths in patients with clots in their leg veins (deep vein thrombosis).

The Cochrane compromise

My concerns began in 2001 during the preparation of the review Anticoagulants versus non-steroidal anti-inflammatories or placebo for treatment of venous thromboembolism. The review was mired in editorial conflict and delayed until 2006. In my account, the editorial leadership presented us with a choice: either withdraw the review entirely or allow the editorial board to alter our conclusions. We authors ultimately stated that the results were “inconclusive” because only “two small studies” were identified, with the added justification: “Since the use of anticoagulants is widely accepted in clinical practice, designing and implementing other similar studies would not be ethical.”

I believe this statement was factually incorrect. There were three, not two, eligible RCTs in the literature:

The second and third RCTs are no longer available online. In 2004, Medscape General Medicine published my paper, Anticoagulation Therapy for Venous Thromboembolism, showing data that I believe point to harm (combined all-cause mortality: anticoagulants 6/66 vs. controls 1/60, p = 0.07). The direction of effect (6 deaths vs. 1) was consistent across all three available studies, which in my view contradicts the “inconclusive” label.

The historical loophole and call to action

How did an unproven, potentially dangerous intervention become an unassailable standard of care? In the 1940s and 1950s, physicians empirically used heparin and warfarin for venous thromboembolism before the first RCT was published. Because of thalidomide causing deformed limbs in infants, in 1962, Congress required drug companies to submit RCT evidence of efficacy before approving drugs for clinical indications. However, drugs already in widespread use, including heparin and warfarin, were grandfathered in by the Kefauver-Harris Amendment and the “generally recognized as safe” (GRAS) loophole. Based on current worldwide epidemiological frameworks, I project that between 75,000 and 120,000 people may have bled to death while taking anticoagulants for VTE since 2006. This is a modeled estimate, not a measured count.

Both of my co-authors have since passed away, and it remains a profound regret of mine that I did not press this issue sooner. Compelled by research integrity, I formally requested that Cochrane retract the 2006 systematic review, publicly acknowledge these data discrepancies, and alert the wider medical community to what I view as a lack of demonstrated efficacy and serious safety concerns associated with these drugs for VTE. Cochrane declined to retract the review.

Editor’s note: The following is a personal account and opinion piece reflecting the author’s own views and recollections. Anticoagulation remains the established standard of care for venous thromboembolism. No patient should stop or change a prescribed medication without first consulting their own physician.

David K. Cundiff is a physician, author, and health care reform advocate whose work centers on transforming the U.S. health care system and addressing broader societal challenges, including climate change. He is a volunteer collaborator with the Institute for Health Metrics and Evaluation.

From 1981 to 1998, Dr. Cundiff practiced, taught, and conducted clinical research in internal medicine and pain control at the Los Angeles County + USC Medical Center, where he directed the Cancer and AIDS Pain Service for nine years, and previously held an academic affiliation with Harbor-UCLA Medical Center. After exposing how systemic inefficiencies increased hospital utilization and revenue, he became a whistleblower, an experience documented in Whistleblower Doctor: The Politics and Economics of Pain and Dying.

He is the author of Grand Bargains: Fixing Health Care and the Economy, which proposes structural reforms to dramatically reduce health care costs while improving outcomes. His essay “Much Better Healthcare for Way Less Cost” explores accountable care cooperatives and community-based reform. Additional works include Money Driven Medicine: Tests and Treatments That Don’t Work and Euthanasia Is Not the Answer: A Hospice Physician’s View.

Outside his professional work, Dr. Cundiff values time with friends and family, including six grandchildren, and maintains his health through Hatha yoga, meditation, swimming, Zumba, biking, and a diet emphasizing minimally processed organic food. He shares updates on LinkedIn.