Two years after the federal Right to Try Act was signed into law, the worst fears of the law’s opponents—that patients would be exploited and otherwise harmed—have not come to fruition. But this isn’t because the law turned out better than expected. To the contrary, it’s barely been used at all. Despite President Donald Trump’s claim that right to try could help hundreds of thousands, fewer than 10 patients are publicly reported to have received unapproved drugs through this pathway.
A new for-profit cancer clinic is aiming to change that. However, as explained below, this initiative poses serious concerns for patients and illustrates the flaws of right to try.
Expanded Access Versus Right To Try
Right to try allows seriously ill patients to access certain unapproved drugs outside clinical trials without the Food and Drug Administration’s (FDA’s) blessing, so long as companies are willing to provide them and various statutory criteria are satisfied. The law stands in contrast to the FDA’s longstanding expanded access pathway. Expanded access also allows patients to access unapproved drugs for treatment use but requires the FDA to sign off, which the agency does more than 99 percent of the time.
Several reputable companies have acknowledged the value of FDA’s involvement in overseeing expanded access requests, especially since the agency sometimes has unique access to information to guide physicians’ use of an investigational drug. FDA oversight can also help protect patients against bad actors who would seek to take advantage of them. In addition to stronger oversight than right to try, expanded access includes more stringent requirements to collect and report safety data. These safeguards, missing from right to try, may soon become very important.
The United Cancer Centers Model
Earlier this month, the private equity group Vivaris Capital announced plans to launch a financial investment product to support a new health care system called United Cancer Centers, Inc. (UCC). The UCC was formed by the owners of CHIPSA Hospital, an alternative medicine hospital in Mexico, to offer “integrative cancer care” under right to try in the US. More specifically, the UCC aims to “redefine the concept of informed decision-making for cancer patients by providing access to a wider array of both FDA-approved and investigational treatment options.” Investors are promised the opportunity to “support this meaningful work” while turning a profit.
On its face, the UCC model may seem appealing. For a membership fee, patients are promised access to a clinical care team composed of a geneticist, immunologist, nutritionist, oncologist, and psychologist who will offer a personalized care plan. Genetic tests from both the patient and their tumor will be used to create a menu of options, including standard-of-care oncology services reimbursable by insurance and “[right-to-try] drugs,” which will be provided to patients at cost (as required by law).
The UCC website includes reference to expanded access, suggesting that right to try will not be the exclusive pathway for the clinic’s patients to access drugs before they are approved. But it also emphasizes barriers to expanded access without acknowledging those that are shared with right to try, such as the requirement that patients have a serious or life-threatening condition and are not eligible for trials of the requested drug. Early reports suggest that the UCC plans to limit its use of the right-to-try pathway to drugs that have already been authorized for expanded access, although the clinic’s leadership claims that, by comparison, right to try will offer streamlined, more immediate access. Again, this is only part of the story, since the FDA typically approves expanded access requests in just a few days.
Concerns Raised By The UCC Model
Overall, the UCC claims that it will move beyond informed consent to informed decision making, educating patients on their full assortment of options, including relevant scientific data and trade-offs. But there are several concerns about the proposed approach.
A History Of Suspect Treatments
First, the UCC’s predecessor, CHIPSA, has a history of offering unproven and suspect treatments. Among other “alternative” treatments, the hospital offers a specialized diet-based regimen called Gerson therapy aimed at “detoxifying” the body and treating cancer through vitamins, minerals, and coffee enemas. According to the National Cancer Institute, there have been few clinical research studies published on Gerson therapy, while there have been documented adverse events associated with coffee enemas, including three deaths.
Other interventions offered by CHIPSA have been described as “nonsense” and “quackery.” This gives little reason for confidence that the UCC will take more care with the treatments it offers, investigational, alternative, or otherwise. And although the UCC is touting informed consent, the unsubstantiated claims on the CHIPSA website suggest that the UCC may present patients with exactly the sort of unproven claims regarding experimental treatments for which the FDA (and institutional review board) oversight—present under expanded access but not right to try—would be particularly helpful.
Large Out-Of-Pocket Costs For Patients
Second, although the UCC cites right to try “as a pathway for maximizing the affordability of drug therapies for cancer patients,” it fails to expand on that claim. Simply providing right-to-try drugs at cost in no way guarantees affordability. The costs may be substantial, and these drugs won’t be covered by insurance since they haven’t yet demonstrated safety or efficacy, leaving patients to pay out of pocket. And the drugs won’t be the only costs—presumably, there will be charges for visits and everything else that comes along with them. These costs are largely unregulated, so that’s where companies such as the UCC stand to profit. Inevitably, some patients will end up crowdfunding their unproven care on sites such as GoFundMe or taking on substantial debts.
Expanded access is not immune to these financial concerns. But the concerns are intensified when access to investigational products is pushed by a for-profit entity backed by private equity. How likely is the UCC or any similar company to highlight how few investigational products are ultimately approved, given that their profits will be on the line? Language on the UCC’s website suggests it is far more likely to refer to unapproved drugs as “cutting edge therapeutic interventions” and “validated immunotherapy.” But these drugs shouldn’t be put on par with those that are FDA-approved.
The Potential For Problematic Companies To Dominate Right To Try
Finally, the UCC may be making promises it can’t keep. Many companies have expressed little interest in right to try, preferring to proceed with the expanded access pathway. So, who will the UCC work with? If reputable companies steer clear, there is reason for concern about who will be left. Even if the UCC plans to limit its use of right to try to drugs that the FDA has previously authorized for expanded access, that won’t help much, since the FDA is usually making those judgments in reference to individual patients based on their specific risks and potential to benefit. Just because the FDA says yes to one patient doesn’t mean that an investigational drug is appropriate for all others.
Expanded access is not perfect. There’s room to improve awareness among physicians and patients, as well as a need to address financial and logistical considerations for both companies and patients that sometimes place expanded access out of reach. Nevertheless, as between expanded access and right to try, expanded access is the preferable choice for patients who’ve exhausted their standard treatment options—and if that’s all the UCC is ultimately able to offer, patients will be better off. Right to try has accomplished nothing in the years since the first state enacted a law in 2014, except raising and dashing the hopes of desperate patients and their families. Now, investors are being solicited to sell hope to the dying, with no protections to ensure that the hope is justified. Buyer beware.
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Private Equity And Right To Try: A Dangerous Combination - Health Affairs
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