Update, June 2022: The purported researcher responsible for the experiment described in this film, Serhat Gumrukcu, was indicted for murder-for-hire at the end of May 2022. The case is ongoing. In parallel, two independent investigations by financial media outlets (Hindenburg Research and Sharesleuth) have presented extremely disturbing findings about Gumrukcu’s past and were unable to confirm that he ever gained qualification to be a medical doctor. Pending that confirmation, the previous references in this article to “Dr. Serhat Gumrukcu” have been amended.
Examples of media coverage:
- “A Wild Journey”: Long-Term HIV Survivor Jeffrey Drew Risks His Life To Undergo Experimental AIDS Cure In ‘Right To Try’ – Matthew Carey, Deadline, December 7, 2021
- Peacock Buys Octavia Spencer’s HIV Cure Doc Short ‘Right To Try’ – Tom O’Brien, Central Recorder, December 1, 2021
- Peacock Picks Up Octavia Spencer-Produced HIV Cure Doc Short ‘Right To Try’ – Peter White, November 30, 2021
- 2021’s Amazing People Living with HIV: Right to Try’s Jeffrey Drew – Neal Broverman, HIVPlus Magazine, November 12, 2021
- RIGHT TO TRY: On-Going Dilemma of Big Pharma & HIV – Valerie Milano, The Hollywood Times, August 20, 2021
- How Octavia Spencer Came to Produce a Doc on a Potential HIV Cure – Daniel Reynolds, Out Magazine, August 20, 2021
- Octavia Spencer’s Production Company Boards HIV Cure Documentary ‘Right to Try’ – Marc Malkin, Variety, July 21, 2021
- Right to Try short film – Outfest Los Angeles, August 2021
On the surface, this short documentary film is likely to seem benign and hopeful to many viewers. Jeffrey Drew, the Los Angeles-based long-term survivor living with HIV at the center of the story, comes across as warm and generous. The film appears to highlight his selflessness in participating in an experiment that required stopping approved antiretroviral therapy (ART) and receiving an experimental intervention that is suggested to be a potential cure for HIV.
Drew’s commitment is contrasted with information on abusive pricing and patent-preserving tactics on the part of the pharmaceutical company Gilead Sciences, largely conveyed by extensive use of footage from a Congressional hearing in 2019.
The involvement of actress Octavia Spencer as producer and the purchase for streaming by the NBC service Peacock will likely add both to the reach of the film and the impression that it’s credible. Octavia Spencer has promoted the film in appearances on both the Late Late Show with James Corden (where the film’s director, Zeberiah Newman, is a producer) and the Ellen DeGeneres Show.
But the unfortunate reality is that there are multiple aspects of the film that are deeply problematic (and in at least one case, dishonest). It’s regrettable that seemingly no one involved in producing, selling, or buying the film for distribution was able to recognize its flaws.
There’s a lot to try to unpack and explain for such a short film. Much of the background information is complex and cannot be summarized simply. Some key points include:
- Essentially no clear information is provided on the experimental intervention that Jeffrey Drew received, who made it, or how he came to receive it – even though much of that information is publicly available. The film closes with a text slide that states: “the doctors and scientists conducting the experiment declined to speak on camera” but that doesn’t preclude the filmmakers from naming them. The lead scientist and his medical and research organizations appear at least somewhat dubious (see below for more details).
- The film interviews Los Angeles doctor and HIV researcher W. David Hardy on camera, who states: “there’s a law allowing physicians and patients to try something experimental if the currently available medications aren’t working, it’s called the Right to Try law and this is part of that. It’s not really a clinical trial it’s really kind of an alternative experimental investigational treatment for individuals whose virus has not responded well. And if the results are promising then you can present it to the FDA and do a real clinical trial.” This appears to be a misrepresentation of the Right to Try law, which requires that “a Phase 1 clinical trial has been completed” for an intervention to be eligible for administration under the law. California’s State Right to Try law has the same requirement. Representatives of Enochian Biosciences, the biotech company commercially developing the intervention, have also stated it was not given under right to try law. The film’s title is therefore also likely a misrepresentation. W. David Hardy is listed as a “Scientific and Medical Advisor” to the Seraph Research Institute, which led the experiment, seemingly contradicting the film’s statement that “the doctors and scientists conducting the experiment declined to speak on camera.”
- The word “trial” is used repeatedly (including in the trailer), but Drew is not participating a clinical trial. A clinical trial typically involves multiple participants with the aim of generating high quality information about how an intervention behaves in people. An experiment involving one person cannot generate that type of reliable information.
- Drew states on camera that he did not tell his primary care doctor about his participation in the experiment, and there’s no explanation of the potential dangers posed by such a decision (in any emergency requiring administration of a medication or therapy, it’s vital that a doctor know what else an individual is receiving).
- As can be seen from the promotional text on the website for Outfest, where it was first shown, the film has a conspiracy angle: “Medical trials are being done in secret, out of reach of pharmaceutical companies that may try to shut them down.” This is false in multiple ways:
- This was not a clinical trial.
- Medical trials cannot legally be conducted in secret (for good reasons primarily related to participant safety).
- Pharmaceutical companies cannot shut down other people’s clinical trials.
- The film is essentially serving to promote one for-profit company’s experimental HIV therapy candidate, without offering any evidence that the profit-making intentions of that company are materially or morally different to the other for-profit pharmaceutical companies whose ethics the film questions.
- The film is dishonest about the position taken on Right to Try law by what are referred to as “HIV advocacy groups.” A text slide is shown stating: “Because HIV is now considered a chronic manageable condition, HIV advocacy groups oppose the use of Right to Try law for HIV patients. These groups all declined to speak on camera.” This is another claim that is false in multiple ways:
- The Right to Try law doesn’t apply to the vast majority of people with HIV by intent. The law is for “patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options.” The film’s claim is nonsensical because the fact that HIV is now a chronic manageable condition for most people is the reason why the law doesn’t apply, it’s not the reason anyone opposed the law. The filmmakers appear to be implying that HIV shouldn’t be considered a chronic manageable condition and that Right to Try should allow people with HIV to stop treatments that are proven to be effective and participate in experiments involving unproven therapies instead. But Right to Try law doesn’t allow this.
- HIV advocacy groups – along with many other patient groups and respected research organizations – did oppose the passage of the Right to Try law due to concerns that were very clearly explained, including redundancy with existing mechanisms of access to experimental therapies and the allowance for people to be charged for access. See the letter in opposition that TAG co-signed.
- Since Right to Try law passed, no HIV advocacy group that we know of has opposed the use of the law by people with HIV.
- Exactly who was contacted and asked to speak on camera from “all” the unnamed HIV advocacy groups is not specified. TAG was contacted repeatedly by the director Zeberiah Newman, but he never specifically asked anyone to go on camera to explain our position on Right to Try law (documents explaining the opposition to the law were shared with him). The concerns we expressed about the film went unheeded.
- Ironically, some of the same HIV advocacy groups that the filmmakers take a swipe at with their false statement about Right to Try law were responsible for the initiation of the Congressional hearing on the pricing of the Gilead Sciences HIV drug Truvada that is the source of much of the film’s footage – primarily PrEP4All, but TAG also worked with Congressional aides and submitted testimony.
The Adoptive Immunotherapy Intervention
The intervention administered to Jeffrey Drew was developed by Serhat Gumrukcu who is affiliated with (and apparently a founder of) both Seraph Medical and the Seraph Research Institute in Los Angeles. Gumrukcu is also “inventor and co-founder” of Enochian Biosciences, the company commercially developing the approach (according to a disclosure slide, Gumrukcu receives a salary from the company and owns stock).
Online searches reveal evidence that Gumrukcu has both prior criminal (see here and associated sentencing transcript) and civil court judgments against him.
Seraph Medical has apparently been offering their “distinct approach to treating HIV and AIDS” for at least a year (the first snapshot of their website is in the internet archive on December 2, 2020).
The website has also claimed: “long before groundbreaking pharmaceuticals for HIV existed, we were helping patients with HIV keep their viral loads down through various therapies and lifestyle recommendations that enabled their immune system to stay strong.”
This statement was subsequently removed after “Right to Try” premiered at Outfest, as can be seen by comparing the current version to the preceding snapshot in the internet archive (the last four paragraphs were deleted, and this edited version is first captured in the internet archive on August 30, 2021, a week after Right to Try was first screened to the public).
The exact nature of Seraph Medical’s approach is not specified but is said to involve “various therapies and lifestyle recommendations” to somehow bolster the immune system. The cost of the therapies is not specified, although the website notes “Seraph Medical’s initial evaluation and initial consultation fee schedule is $1500 USD for patients with non-cancer related conditions.”
The website also makes the false claim that:
“The goal of [HIV] medications is to achieve what is known as an ‘undetectable viral load.’ When the viral load stays below 50,000 – 60,000 copies of the virus per milliliter of blood, antiretroviral drugs are no longer needed. When the load reaches 100,000 copies per milliliter of blood, the patient must begin treatment again with pharmaceuticals.”
This is a serious misrepresentation of the well-established goals of HIV treatment. An undetectable viral load means below the limit of detection of the test (typically 50 copies or less) not “below 50,000 – 60,000 copies.” Persistently detectable viral load is associated with increased risk of illness and death, as well as risk of HIV transmission.
(After this article was posted, the webpage was edited again to amend the undetectable threshold to the accepted standard of less than 50 copies, but the previous version is available in the internet archive. As of June 16, 2022, the entire Seraph Medical website is inaccessible due to password protection.)
Whether Serhat Gumrukcu is involved in these treatment protocols is unclear; he has previously been criticized based on evidence that he was practicing medicine at Seraph Medical in California without a license (in that instance, it involved Seraph Medical’s promotion of leech therapies for food poisoning).
The specifics of the intervention administered to Jeffrey Drew are described in an online presentation by Serhat Gumrukcu from the annual meeting of the American Society for Cell and Gene Therapy. At the time the experiment was planned, Drew was on ART but viral load was not fully suppressed (the level was around 2,000 copies/ml). Drew was diagnosed HIV-positive in 1986 and had an extensive previous history of single and dual ART regimens. ART was completely stopped when the experiment began.
The intervention comprised immune system cells sampled from an HIV-negative donor, which were then infused into Drew’s bloodstream. Prior to the infusion, chemotherapy was administered to deplete existing immune system cells and “make space” for the donor cells. The cytokines alpha interferon and IL-2 were also given (twice and four times, respectively).
Infusion of donor immune cells is called adoptive immunotherapy, and a novel aspect was that the researchers focused on the transfer of rare subsets of immune cells called natural killer cells and gamma-delta T cells. The film at one point accurately notes that the approach involved infusions of donor immune cells, but also makes several inaccurate references to it as a “vaccine.”
Whether there is any connection to the immune-based therapies Seraph Medical appears to sell to people with HIV is unknown. Exactly how the experiment was authorized by the US Food and Drug Administration (FDA) is unclear, but the presentation notes approval was received from an Institutional Review Board (IRB). IRB approval is not required for the use of interventions under Right to Try law.
After an initial increase to around 3 million copies/ml, Drew’s viral load is reported to have slowly declined, eventually becoming undetectable (by accepted standards, not Seraph Medical’s) after around six months of follow up. Viral load is shown to have remained undetectable ever since, which is now a little over a year (as is noted at the end of the film).
The results appear potentially encouraging and are said to be under investigation by additional researchers at the National Institutes of Health. There’s no information available regarding what the mechanism of HIV suppression might be (for example, no data has been reported on immune responses against HIV). Prior research has indicated that some individuals who maintain low but detectable viral loads on ART—as was the case with Jeffrey Drew prior to the experiment—display higher levels of HIV-specific CD4 and CD8 T cell responses compared to people with undetectable viral loads or uncontrolled HIV replication.
The film alludes to additional individuals with HIV who also received the adoptive immunotherapy with differing results but provides no specifics.
The approach is being commercially developed by Enochian Biosciences, who have reported receiving positive signals from the FDA regarding their plans to conduct a clinical trial (the news increased their stock price by 114%). A further update in October 2021 stated that the company has received comments from the FDA, and is now working to prepare and submit the investigational new drug application (IND) required to initiate a trial “in the near term.”
The reasons why a proper clinical trial couldn’t be conducted in the first place aren’t explained in the film. Representatives from Enochian Biosciences have suggested that the FDA was (or would have been) reluctant to allow administration of an experimental intervention to people off ART with detectable viral loads, but the agency has previously greenlighted studies of experimental gene therapies and broadly neutralizing antibodies in this population. It does seem plausible that the FDA would have reservations about allowing a viral load rebound to over 3 million copies/ml given the risks associated with detectable viral load and the potentially dangerous burst of inflammation that accompanies such spikes in HIV levels in the body.
There’s no obvious explanation for why Drew was asked to stop ART prior to the administration of the adoptive immunotherapy (and the associated chemotherapy and cytokine regimen). Clinical trial designs typically involve interrupting ART after an intervention has been received to assess whether viral load rebound is prevented or controlled, to avert the risks associated with the high levels of HIV replication that Drew experienced.
In Octavia Spencer’s appearance on the Late Late Show with James Corden, she described the experiment as “very dangerous” as if that makes it more admirable. A key goal of ethical research is to be as safe as possible.
Big Pharma and Cures
The overall narrative of the film strongly implies that the interest of big pharma in selling pills to be administered daily means that they are somehow impeding cure research. There is also an implication that Drew’s “HIV doctor” is in on this conspiracy, and hence cannot be told about the decision to stop ART and participate in the experiment because otherwise Drew risks being “cut off from the system.” This is not too distant from the widespread conspiracy theory that a cure for HIV exists but is being withheld so drug companies can profit.
There is a superficial appeal to this narrative, but it does not jibe with reality. Hepatitis C is a viral infection that was well suited to being treated by daily administration of pills. But it turned out to be curable, and you don’t need to have any affection for big pharma to recognize that their priority became developing simpler, shorter, safer hepatitis C cures—not out of charity, but to have a competitive advantage in the market.
In HIV, the market is crowded with daily regimens, which have become simpler and safer since effective ART was first developed in the mid-1990s. The incentive for companies now is to develop regimens that require less frequent dosing (see the recent approval of Cabenuva injections), and a cure would be the ultimate intervention for avoiding frequent dosing. Hence several big pharma companies do have HIV cure research programs.
Importantly, however, big pharma does not set the agenda for HIV cure research. As can be seen from the most recent estimate of global funding support in 2020, public mechanisms—primarily the U.S. National Institutes of Health (NIH)—account for the majority of the financing. This is exemplified by the recent announcement of ten five-year Martin Delaney HIV cure research collaboratory grants funded by NIH. Pharmaceutical and biotech companies can be partners in these collaboratories, but they are led by academic investigators.
The concerns the film articulates about the high cost of medicines and unethical pharmaceutical company practices to extend patent life are very real, as is evidenced by the high cost of brand-name hepatitis C cures. There is every reason to worry that an HIV cure would be priced prohibitively, at least initially, but there is no obvious reason to think this is more likely to be the case for a cure developed by big pharma versus a biotech like Enochian Biosciences.
The film also neglects to address the fact that adoptive immunotherapy involving cells sampled from donors is complex and expensive. One of the articles covering the release of the documentary states that Drew is “participating in an experiment that could lead to an historic medical breakthrough for the millions of people living with HIV around the world.” In fact, it’s far from clear that the intervention could be made accessible to people with HIV globally even if it was proven to work.
Most frustratingly, studies have found that belief in this type of conspiracy narrative about big pharma blocking (or hiding) cures is most prevalent among populations with valid historical reasons to distrust medical research, and is associated with lower adherence to HIV treatment. And lower adherence is linked to higher levels of inflammation and a greater risk of illness and death compared to people who maintain adherence. So while the film articulates concerns about how the high cost of HIV treatments can exacerbate healthcare disparities, it is at the same time promoting conspiracy beliefs that lead to healthcare disparities.
HIV Cure Research
The film provides no information on the very significant amount of ongoing clinical research related to developing a cure for HIV infection.
A good source on this topic is the updated International AIDS Society Towards an HIV Cure Global Scientific Strategy, which was published on December 1, 2021 in the journal Nature Medicine. A plain language explainer is also available from HIV i-Base. Treatment Action Group maintains an online listing of HIV cure-related clinical research, which currently includes more than 90 interventional trials.
An issue that advocates care greatly about is ensuring the informed participation of people with HIV in cure research.
As depicted in the film, Jeffrey Drew’s involvement in Serhat Gumrukcu’s experiment is very clearly nobly motivated. But the amount of information and insight he has into the research appears far from optimal. At the opening of the film, he states: “my commitment to this trial, it is worth dying for.” But in the last scene, he laments the lack of information and support he is receiving from the researchers and says: “being involved with this trial has made me even more baffled by the whole process.”
The film had an opportunity to investigate and shed light on the experiment Drew is participating in (and potentially also the process of HIV cure research generally), but sadly it completely fails to do so.
In the worst-case scenario, the film’s simplistic message that stopping HIV treatment is a laudable act of rebellion against big pharma will cause harm.