The most important part of my Galmed story is what transpired after they removed me from the ARMOR double blind Phase 3 Aramchol trial. Shortly thereafter the Phase 3 trial was suspended and Galmed CEO Baharaff stated that participants would be unblinded (notified whether they were receiving Aramchol or placebo). But having been already removed they would not unblind me in spite of my repeated pleas. This alone captures the essence of Galmed. Galmed is rotten to the core. If you are considering participation in such a trial understand that you are nothing more than a guinea pig and collateral damage. That said here is my Galmed story.
Trial starts with participant signing Informed Consent. FDA guidelines establish important but non-binding guidelines. Section 1.28 states “informing of all aspects relevant to the participant decision to participate in trial”. Informed Consent created by Sponsor (Galmed) approved by Institutional Review Board (IRB) omits several key points of information while misrepresenting others
- Aramchol drug that was approved for Phase 3 study had patent expiring in 2023 and so would never be marketed. Instead Galmed’s intent was always to petition FDA to substitute with another similar drug called Meglumine with patent protection to 2035 without reverting back to Phase 2.
- Informed Consent states “Clinical trial policy insurance to cover the Sponsor’s legal liability … for injuries that directly result from the study drug or procedures required by the study protocol will be maintained by the Sponsor”. In fact such insurance is not required in U.S. as it is in other countries. I asked for the name of the insurance provider and no name was provided. Informed Consent further states “If you have a research related injury reasonable and necessary medical care will be available to you. The cost of care … will be paid by the Sponsor of the study”. Since Sponsor is apparently not maintaining liability insurance in U.S. and Sponsor is located in Israel the chances of recovering such cost of care probably slim.
Had I been made aware of these things I would not have signed up for the trial.
In July 2020 I started on the trial and made all required trial protocol appointments. March 2020 FDA published document describing how to conduct clinical trials during COVID. Sponsors and investigators were given option to conduct video visits, to collect blood using local labs, and mailing study drugs. November 2020 earnings call Galmed gave investigators discretion in conducting the trial. January 25, 2021 scheduled visit I asked investigator to allow me such discretion. I expected that I would be receiving COVID vaccine shortly due to my age and co-morbidities. Investigator contacted Galmed who refused such. Interesting to note that investigator who is sitting on Galmed advisory board wrote this article. On January 20, 2021, one day before deadline to inform investigator whether or not I would show up, I was informed that my participation was being terminated. I was the only participant at this particular location (Jefferson Hospital in Philadelphia PA). Other locations throughout the U.S. were unable to recruit any participants due to strict Phase 3 requirements. Or possibly prospective participants were not so naive and wanted to have nothing to do with foreign corporation with no track record of having marketable drug or knew FDA had nothing to do with approving Phase 3 of double blind trial. Galmed expected 2000 participants worldwide and was only able to recruit about 50 (i was told about such small enrollment by investigator in another location). In fact the most difficult part of NASH trials is participant recruitment.
Having had to endure 6 months of pre-trial qualifications, painful and dangerous biopsy and other tests, another 6 months in trial taking investigational drug, multiple blood draws, only getting paid to cover parking and gas expenses. While I have no way of knowing if I was receiving the drug or just placebo, my results showed no improvement. While Galmed shared my test results with Halegoua who in turn shared them with me, I was told Sponsors test for significantly more things than they share with investigators. Such tests may include biomarkers such as proc-3, elf, and other sophisticated tests only research community knows about. Is it possible Galmed had tests that showed significant deterioration in my condition?
In December 2020 Galmed announced an open-label trial (NCT04104321) to run concurrently with the double-blind trial that I was participating in. All participants in the open-label trial would receive the actual drug. Galmed stated that all participants in the double-blind trial would be given the option of transferring to the open-label trial. I informed Investigator that I would like to exercise that option. Investigator informed Galmed and then I was removed from the trial. While I will never know reasons Galmed wanted me out of Phase 3 trial (expected to last 5 years), my suspicion is that they knew I am on the real drug and not placebo, and that the drug is ineffective in treating neither my NASH or fibrosis conditions. I pleaded with Galmed CEO Baharaff not to throw me out from trial I gave year of my life and did not even get a response. On 1/26/2021 Galmed presentation to investors, CEO Baharaff stated all Phase 3 participants will be unblinded. While I was kicked out of the trial on 1/20/2021 it seems like a decent thing to do for Galmed to inform me if I was taking the real drug. But they did not.
While I can only speculate that I was on real drug and Galmed wanted me out, at the same time I was kicked out from Phase 3 trial, Galmed prepared informed consent for open label trial participants. All accommodations I asked for now offered to new participants
“In case of circumstances directly related to the COVID-19 pandemic preventing holding the visits at the site, the study staff will make every effort for you to remain in the study. They may communicate with you to coordinate an alternative location for holding the visit. Dr. xxxxxx may also choose, for safety reasons related to the pandemic, to replace the face-to-face conversation during the visit, with a phone or video call. In such case you will be notified in advance and the call will be coordinated with you. Do not hesitate to contact the site for any related questions you may have”
This is part of email from Dr. xxxxxx (I am not releasing name because this doctor did not do anything bad to me unlike Dr.Halegoua-Demarzio who in my opinion is a monster for what she did to me). Answer to my question why conduct open label study “Regarding Galmed, I understand that the decision to lend open label access to drug is the incentive that if folks opt to enroll into clinical research during this time of COVID, then we need to minimize risk for receiving a placebo. However, the study will open back up to randomization to placebo in the future, but render access to open label drug to those who elect to participate now. This was strictly an effort to optimize recruitment during a very difficult and challenging time” I am not buying this answer because I don’t think it is possible to get NDA (new drug application) approved with trial that is not randomized and double blind. I am using this quote to show that Galmed was accommodating patients in Covid just not me.
I also noticed in open label informed consent something quite interesting. When I signed mine side effects were itching, now Galmed stating they had one person with lung blood clots and one with gallbladder inflammation. And this is all from handful of people they signed up for double blind Phase 3 last year?
As far as my results? My blood sugar went a lot higher, my liver enzymes did not change, my bilirubin became dangerously high. And I developed shortness of breath and chest pains. Plus I am worried now about liver damage cause by investigational drug toxicity. And I am still unable to see doctors in person or have any tests. And when I finally get that COVID vaccine which Jefferson had ability to provide to me but did not, I expect my medical expenses from tests will cost me thousands. And who is supposed to pay for all this? Obviously me. So much for Galmed responsibility outlined in Informed Consent. Pretty good way to deal with such “responsibility” to throw participant out of the trial and pretend we never heard about you. Here is safe investigational drug such as Aramchol that Dr.Halegoua-Demarzio repeatedly told me as main reason she “selected” Galmed for her trials. And I told her about what happened to me, her response was “I am not your doctor”, go where you came from to get treated. Not even decency to ask Galmed what exactly they fed me. This is Dr.Halegoua-Demarzio with her angelic looking face and 5 star reviews (that cant be possibly be real if you read content) in action. And when I complained to WIRB about my symptoms I was called a liar. Here is organization that is supposed to protect trial participants and who pays for this “protection”? Galmed. And where do some WIRB executives work before they joined IRB? FDA. And this is full circle how sponsors, investigators, IRB and FDA all in it together to allow abuse of trial participants. (Circle actually completes with FDA executives move to become drug companies executives. Probably unlikely considering Galmed is foreign company. But there is a very good example how statins were approved in US https://www.fda.gov/media/110452/download. It is interesting that FDA sees this as success to approve such widely used medication that can do may horrible things to person with liver disease)
And as far as advising open label participants that the drug they will sign up taking may be substituted if FDA gives Galmed approval, not in new informed consent. I am guessing if Galmed wanted to keep them on original drug they would have said so. But why do anything beyond FDA requirements? Interesting wording in new consent: “Clinically relevant information pirating to NASH or of this research will be communicated with you when we Dr. xxxxxxx get it” Is it a joke? Insult to trial participants? Any wording of mysterious liability insurance is gone from new Open Label Informed Consent.
If you are considering getting on one of their trials think about what they can do to you. I urge every prospective participant to consider my experience. I hope others will write about their experience in clinical trials.