Montana Bill Raises Alarm Over Human Experimentation Standards

Montana Senate Bill 535, aimed at expanding access to experimental medical treatments, is drawing sharp criticism from healthcare advocates who warn that it could enable for-profit biotech firms to conduct human trials in the state with minimal oversight.

The Montana Medical Freedom Alliance (MTMFA) raised concern about the bill’s “lack of due process and appropriate professional licensure,” especially regarding its exemption for out-of-state physicians conducting human experimentation in Montana without a Montana medical license​. The Montana Medical Association has similarly warned that removing licensing requirements is discriminatory and bypasses vital vetting of healthcare providers​.

Critics describe the legislation as ushering in a “wild west” environment for human experimentation, with Montana becoming the least regulated state in the nation for biotech trials​. The bill authorizes experimental treatment centers to operate for a $10,000 fee and allows treatments that have only passed Phase I clinical trials—early-stage safety tests involving as few as 20 to 100 participants. According to MTMFA, this phase is designed to detect basic toxicity, not to prove therapeutic benefit​.

The bill’s definition of “experimental treatment” includes a catch-all category for “other treatment,” allowing for virtually anything to qualify. Concerned Montana health groups cited Elon Musk’s Neuralink as an example of the kind of high-risk experimental platform that could move human trials to Montana under the bill. Neuralink’s pre-human trials involved monkey experimentation that resulted in 15 documented deaths, according to public records referenced in submitted testimony​.

At the same time, SB 535 offers broad legal immunity to physicians, manufacturers, and facilities involved in trials—shielding them from lawsuits unless gross negligence is proven. Concerned health professionals note that this departs from industry norms, where informed consent does not eliminate liability and ethical oversight is typically guaranteed by Institutional Review Boards (IRBs)​.

Critics also warn the bill exposes vulnerable populations—including the elderly, non-English speakers, and those in chronic pain—to persuasive corporate marketing. One professional copywriter testified that medical journals are often ghostwritten by marketing firms hired by pharmaceutical companies, not doctors, with the goal of persuading—not informing​.

While proponents of the bill argue it offers “regulatory clarity,” opponents point out that no actual standards exist yet. SB 535 delegates oversight to Montana’s Department of Public Health and Human Services (DPHHS), which must develop rules after the bill is enacted. Detractors fear this could result in founders of experimental treatment centers writing their own rules and receiving DPHHS “rubber stamp” approval​.

SB 535 passed the Senate and is now under review in the House Human Services Committee. The committee is expected to vote either Tuesday or Wednesday.

Concerned citizens can track the bill’s status and are encouraged to contact the committee or the House if the bill passes out of committee at (406) 444-4800 or participate online at participate.legmt.gov.