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The anticoagulant evidence controversy: a whistleblower’s perspective

David K. Cundiff, MD
Meds
December 29, 2025
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My partner broke her femur in a Zumba class just before Christmas 2025 and had successful surgery. Following successful surgery, physicians prescribed Lovenox (an anticoagulant) and Plavix (an antiplatelet drug), the standard regimen for preventing or treating venous thromboembolism (VTE). However, the intervention proved very risky: She lost three pints of blood into her leg and required a two-pint blood transfusion, direct complications of the Lovenox and Plavix.

Physicians adopted anticoagulants such as heparin and warfarin in the 1940s to prevent deaths from leg vein clots (deep vein thrombosis, DVT) traveling to the lungs. This was before randomized controlled trials (RCTs) became the benchmark for efficacy. Because DVT patients usually survived, and autopsies of those who didn’t often show fatal clots, clinicians reasoned that thinning the blood was a life-saving necessity. By the 1950s, this reasoning became an unshakeable medical orthodoxy.

A whistleblower doctor’s story

In 1995, during a financial crisis at the LAC-USC Medical Center, administrators closed my palliative care service. I had previously estimated that our hospice-at-home model saved $9 million annually in hospital revenue (a “loss” the administration likely disfavored). Soon following an LA Times op-ed I wrote on LAC-USC Medical Center hospital inefficiencies, I faced retaliation: a malpractice accusation after a patient of mine with DVTs died of clots going to his lungs. I had withheld anticoagulants in that case due to the patient’s high bleeding risk (alcoholism and liver disease).

Facing the loss of my medical license, I searched for RCT evidence supporting anticoagulant therapy for DVT or pulmonary embolism (PE). The Food and Drug Administration designated heparin and warfarin (anticoagulant blood thinners to treat or prevent clots). My expert witness and I surveyed about 100 physicians. An anonymous physician respondent cited one RCT showing higher mortality in the anticoagulated group (2 of 48) than in those given only an anti-inflammatory drug (0 of 42).

I concluded that anticoagulants for DVT were not evidence-based and might do more harm than good. I told the administrative court judge that if faced with the same case again, I would again stop the anticoagulants. Nevertheless, the judge, with no jury, convicted me of malpractice and revoked my medical license in 1999.

The evidence crisis

In 2001, I proposed to the Cochrane Collaboration to do a systematic review of all RCTs on DVT treatment. Two additional small trials were identified. When publication stalled, I summarized the results in Medscape General Medicine (2004):

Across three trials, all-cause mortality was 6 of 66 among anticoagulated patients versus 1 of 60 among controls receiving no anticoagulants (p = 0.07). This finding (no mortality benefit and likely harm due to bleeding) received no challenge from anticoagulation experts, yet no media coverage followed.

When Cochrane finally published a related review in 2006, the original “not evidence-based” conclusion was softened by editors to “inconclusive,” adding that further placebo-controlled trials would be “unethical” because the practice was already “widely accepted.”

Follow the money

After at least a decade of research and randomized trials comparing direct oral anticoagulants (DOACs) like Lovenox, Xarelto, and Eliquis to treat DVTs, in 2010, the industry introduced DOACs to treat DVTs. These were approved using “non-inferiority” trials, meaning they only had to prove they weren’t significantly worse than heparin, which failed to decrease deaths in DVT patients in each of the three RCTs.

If the 2004 evidence had been acknowledged, the $50 billion DOAC market in 2025 might never have existed or grown to reach a projected $100 billion by 2034.

The FDA’s structural conflicts

The FDA’s reliance on industry funding has long raised concerns. Since 1992’s Prescription Drug User Fee Act, pharmaceutical “user fees” now total $3.5 billion in 2025, creating financial dependency on the industry it oversees.

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While there is no evidence of illegal kickbacks, the “revolving door” between the FDA and drug companies is well documented: Many FDA reviewers later accept positions with firms whose products they evaluated. This legal but troubling practice erodes public trust and raises legitimate concerns about bias in regulatory decisions.

Conclusion

The case of anticoagulants for venous clots illustrates how medical orthodoxy can persist without adequate evidence when reinforced by regulatory inertia and commercial incentives. My experience as a clinician and whistleblower suggests that systemic reform (not merely new drugs) is needed to restore scientific integrity. It is not at all healthy for pharmaceutical companies to be funding the RCTs that get their drugs approved by the FDA.

Before approving or recommending any treatment, medicine must return to its foundation: rigorous randomized trial evidence showing that benefits outweigh harms.

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 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 Whistleblower Doctor: The Politics and Economics of Pain and Dying.

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.

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.

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