I wrote quite long post about my experience in clinical trial with Dina Halegoua-Demarzio. And if you read it you may say maybe it is one off maybe she got her guard down in Covid or something like this. How is doctor with such angelic face can do all these horrible things? She works tirelessly presenting about fatty liver and NASH on local TV, she has 5 star Google reviews, etc. I will present you with one fact first that could leave no doubt about her intentions because her signature is on both documents. I will start with a simple example: So lets say you bought car for $10,000 and financed it with your bank. Bank would not let you drive that car out of dealer lot unless certificate of insurance is presented, bank needs to protect that $10,000 loan. Common practice that happens million times every day. Now look at page 21 of amended informed consent Dina Halegoua-Demarzio approved and signed (bottom of this post and initial consent was prepared long before Covid). It mentions sponsor, Galmed research and development, carrying insurance to pay for damages to participants occurred in clinical trial she was conducting. Now look at letter stating her response to PA attorney general about clinical trial insurance. It is 100% clear she is stating her contract with Galmed requires Galmed to maintain clinical trial insurance but she does not know if such insurance actually exists. IF THIS DOES NOT TELL YOU VALUE SHE PUTS ON LIFE AND HEALTH OF PEOPLE SHE RECRUITING FOR HER TRIALS I DON’T KNOW WHAT WILL. Value of guinea pig’s life is clearly zero. She has staff, she could direct one of number of people working for her to get this information from Galmed, but she did not. If you don’t like the bank protecting their investment analogy how about this? She signed Informed Consent, she is responsible for everything in it including insurance. Now she is just pointing fingers. And further she is simply lying by directing me to get this information from Galmed. She knows I asked and got nowhere and this is the reason I filed complaint with AG. But why is it so hard to obtain insurance information from Galmed? Because it does not exists in my opinion. You will read further why. So why approve informed consent to give prospective trial participant sense of security? I am aware FDA sometimes asks for marketing materials to determine if clinical trial participants were not tricked in to sign up for trial. I am guessing this is common practice and having this insurance was one of the reasons I signed up for her trail with potentially dangerous investigational drug. If this is not proof of lack of care, professionalism on behalf of Dina Halegoua-Demarzio, read no further. You clearly someone she is looking for her trials. She actually told me her trial participants cant even count pills possibly implying they are so dumb
My Investigator Dr. Dina Halegoua-Demarzio works in big not for profit research hospital. While it is unlikely to find for profit research hospital it is important to consider investigator’s employer. I will write about Jefferson in separate post.
Investigator is medical doctor hired by Sponsor (Galmed) to conduct clinical trial.
what investigator is supposed to do
The most important thing to understand from my blog, clinical trial is about research and not about treatment. The biggest mistake you will make if you think investigator is your doctor. In my case I was referred to investigator by my doctor and when Dr. Halegoua had no further use for me she sent me back to my doctor.
Dr. Halegoua has 10-15 years of experience as a medical doctor, it is highly unusual that she is in charge of a hepatology department at a major hospital. Doctors heading such department will have decades of experience.
I blame Dr. Halegoua-Demarzio for this painful experience I incurred at her hands. Anyone who considers her as a doctor should read this.
Dr. Halegoua has only 5 star reviews posted about her in all review sites, according to reviewers she saves their lives, she is best doctor ever. They are not saying what exactly she did for them. Liver transplant? There is no treatment for NASH. Did she tell them to lose weight? Take Vitamin E? She does have a pleasant disposition, does that qualify her as a good doctor? Is this reason for 5 star reviews?
I suggest to ignore all these 5 star reviews. Everything I say has proof. It really takes “special” person to do what she did to me.
But she has no remorse and it is worth noting that she is still recruiting participants for Galmed trial. These are the current trials she is conducting:
Regenerate study NCT02548351, Navigate study NCT04365868, Voyage study NCT04173065, NCT04399538, ARMOR Study NCT04104321. Possibly she will get new study from Galmed for new drug called Amilo-5mer.
Clearly she thinks what Galmed did to me is perfectly acceptable and she wants to continue to do business with Galmed. Clinical trials are business. I don’t know how Jefferson operates but independent clinical research companies have business development departments.
My informed consent starts with wording to ask as many questions as I want. I took it at face value and asked lots of questions.
- I asked Dr. Halegoua when Galmed Phase 2 Aramchol results will be published on clinicaltrials.gov. She assured me it will be published. Unless FDA approves Aramchol as marketable drug it is highly unlikely Galmed will publish results. As of today Galmed is over 2 years late.
- I asked Dr. Halegoua how FDA knows that results submitted are real. She said she does not know. She should know.
- I asked Dr. Halegoua what will happen with trial if another covid lock down order issued. She assured me Galmed will come up with plan. They did in fact come up with such a plan, just not for me
- Dr. Halegoua’s last email to me before my appointment to start on investigational drug was a promise to take care of me and leave worrying to her. She only took care of herself in this trial.
When I showed up for my first trial appointment, person who runs gastroenterology and hepatology research department at Jefferson, Cindi Miller, RN was yelling her lungs out at me for sending so many emails, asking so many questions. She has 35 year career at Jefferson. She must think she owns the place and can abuse patients because she is the one bringing clinical trial money to Jefferson. She was screaming at me that her department people including Investigator lives do not revolve around me. (I never marked any emails as urgent). She then proceeded with crazy accusations that I should not be listening to Galmed earning calls because somehow me registering to listen to a call will unblind me to Galmed. I am assigned patient number in clinical trial, my name is concealed. Several of my questions to investigator were from listening to Galmed calls. I urge anyone who is participating in clinical trials listen to calls and talk to companies. I talked to other NASH sponsors after I was removed from trial, no one saw it as a problem. Why would Cindi Miller wanted to keep me in the dark? Ms. Miller also told me that she will remove me from trial if I don’t stop my behavior. That patient abuse appointment was in front of Dr. Halegoua-Demarzio. She never said single word to Ms. Miller to stop this abuse. There is a record of my very high blood pressure at Jefferson after that incident.
I started with the trial on that day and continued with all my trial appointments while COVID positivity rate was about 3%. As 6-month trial visit approached positivity rate was at 15%. I asked Dr. Halegoua-Demarzio if I can have COVID accommodations as outlined in FDA document. Or what some sponsors did to allow flexibility during covid. She said she will check with Galmed and subsequently wrote me letter on 1/19/2021 stating that Galmed would not allow it. And day before I was supposed to tell her if I was coming in for trial visit, she sent me email informing me she removed me from the trial using “various” wording of Informed Consent. Basically Informed Consent I signed allowed removal from trial without any reason.
While I was negotiating with her in good faith to have my 6 months visit according to FDA guidelines this is what she wrote to me on 1/8/21
“ I am so sorry that this is causing you so much stress. It is upsetting to us as well. I am checking with our IRB on best approach. I wish I could get you the vaccine but do not have that power”.
So she knew about my stress and my hypertension and Jefferson was giving vaccines left and right. While I will never know why she threw me out on 1/20/2021 is it possible she was just coordinating with Jefferson legal department, IRB and Galmed to throw me out?
She refused to discuss dismissal with me. She refused to have end of trial visit with me as outlined in Informed Consent. Basically she had no need for me anymore so she threw me out without any explanation.
I am presuming she signed FDA Form 1572 that clearly states in comments portion that she has the power to make changes in protocol to protect safety of participants. She refused to make changes according to FDA recommendations.
Is Dr. Halegoua-Demarzio what her Google reviews portray her?
- “She is the most kind, caring, thorough, thoughtful, amazingly skilled Doctor. She takes the time to address all of your concerns.”
- “Dr. Halegoua is the best. She saved my life. Very understanding, a professional. And listens to her patient first hand.”
Or is she someone who tricks patients to take potentially life threatening investigational drug and then throws them out when she no longer needs them? I have proof of what happened, so I think latter.
Letter that she sent to me on 1/19/2021 also had unproven allegations that I repeatedly asked research department staff if I was on placebo. This allegation simply shows what she thinks of trial participants intelligence. To accuse me that I don’t understand what randomized double blind trial is simply crazy. The only trial that is acceptable for NDA application to FDA is randomized double blind trial I was on. I certainly did keep track of my tests, but to accuse me that she could possibly know if I was on placebo is simply insane. It defeats entire purpose of trial. Only a handful of people at Galmed knew if I was on real drug. I asked her to remove such baseless accusation from her letter or at least provide basis for such accusation. She refused but she also acknowledged that letter was sent to others. I have no idea to whom she sent this letter. But I find it interesting that other investigators running NASH clinical trials would not respond to my emails. That is highly unusual. Getting email from person willing to take investigational drug and stating I have qualification for trial you are running is a gift to investigator. Why would they refuse such a gift?
There is another important aspect to consider when deciding to participate in one of Dr. Halegoua clinical trials. Galmed prepared informed consent and provided it to Dr. Halegoua , who probably approved it because her signature is there. The only signature is there is hers and mine. Informed consent, page 21 provides wording for clinical trial insurance to cover sponsor legal liability in respect of claims for injuries resulted from study drug or procedures required by study. I relied on this representation when deciding to enroll in clinical trial conducted by Dr. Halegoua. I felt with Galmed being foreign corporation with no record in of any approved drugs having insurance was one of the reasons I signed up with Dr. Halegoua. When I asked Galmed to provide name and contact for such insurance company, Galmed did not respond. I filed complaint with PA Attorney General who contacted Jefferson Hospital on my behalf. Jefferson replied that such trial insurance exists, but they don’t know name and I should contact Galmed for such information. When I told AG rep that I am unable to get such info from Galmed, I was told that Galmed is a foreign corporation and out of AG control. I asked my Congressman office to find out if clinical trial insurance is required in US. FDA response:
“Following up on your constituent’s question, “Can you confirm with FDA that there is no federal law requiring any insurance for trial participants,” please see our response below. Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects. The Food and Drug Administration (FDA) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.
The FDA regulations do not require that a sponsor company carry insurance for clinical trials. However, we are aware that some countries may require a sponsor to carry clinical trial insurance.
FDA’s informed consent regulations (21 CFR 50.25(a)(6)) do require that, for research involving more than minimal risk, the informed consent form provide an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. FDA expects investigators to ensure that subjects have access to reasonable medical care during their participation in the clinical investigation (see FDA’s Guidance for Industry Investigator Responsibilities –Protecting the Rights, Safety, and Welfare of Study Subjects).”
I think it is safe to assume that Galmed did not obtain such clinical trial insurance for patients recruited in US trial. I never saw it mentioned in any of informed consents I read from other sponsors or even in open label trial Galmed was conducting in different location. What would be implication of having non existing insurance for legal liability of sponsor in foreign country in informed consent Dr. Halegoua approved? Did she want to give prospective participants comfort of insurance protection so more people would sign up? Or just plain ignorance on her part? Or maybe both? I have no idea, but what ever reason is for such unacceptable and incompetent behavior, do you want to trust your life to Dr. Halegoua with investigation drug that may kill you or seriously damage you? I would be very afraid of Dr. Halegoua. Indication of how she approved informed consent may be indication how she conducts her clinical trials.
And why she is agreeing to be investigator in trials that sends patient straight to dangerous biopsy without MRI assessments? Fibroscan I had before she decided to send me to biopsy is not reliable. From every trial I read on clinicaltrias.gov standard is Echosense fibroscan, mri, biopsy. Echosense is FDA cleared and not approved device. If you want to read about FDA clearance loophole read my FDA post. It may save your life. Did she want trial so badly that sponsor saving $5000 for MRI was more important than endangering prospective participant lives with invasive procedure? I do not know. Just asking questions.
There is another instance of how well Dr. Halegoua pays attention to study she is getting paid for. She released all study results to me after she reviewed them. She released biopsy results to me that had typo which stated incorrect fibrosis number. I pointed it to her in email and she had radiologist to correct typo. But this resulted in unnecessary stress to me as fibrosis number was dangerously high. If you want to be in her trial be ready to do her job. Make sure you have expertise.
If you read her 1/19/21 letter to me (page 2) she states about future promising drugs to treat NASH. As of 1/19/21 phase 3 trials for NASH failed to meet endpoints, stopped or NDA was rejected by FDA. Does she know that fibrosis is progressing disease leading cirrhosis and cancer? Did she read any studies about how long it takes to progress each stage of fibrosis? Or cirrhosis or cancer? Does she have any inside information that FDA will eventually approve NASH drug? I am guessing answer is no to all of the above. Or she just want to feed me lies knowing well enough I know that she is lying?
You are not going to read this in 5 star reviews about her. Everything I say about her is based on facts. I have no idea why this sloppiness, possible negligence on part of Dr. Halegoua. Is it possible she just overworked? Dr. Halegoua shows pictures of herself with 2 small children. May be her family obligations take priority over her clinical trial obligations to patients? May be writing research papers to have her name known take priority? There are could be many things I have no way of knowing. But all of it should be consideration in enrolling in one of her trials including fact that research department run by Cindi Miller who exhibited herself in very unprofessional matter in my opinion. If after you read all this and ask Dr. Halegoua to tell you her side of the story, she may tell you nobody ever complained, my situation is unique, etc. My answer to this it took COVID 19 to reveal who Dr. Halegoua really is. A cruel person who only cares about getting rich and advancing her career at the expense of people like me.
What would be explanation for such life endangering investigator behavior? While I have no idea of her career goals, here are my thoughts.
In NASH field there are maybe 5 investigators that could be identified as Principal Investigators. Sometimes Principal Investigator can be investigator at a specific site. What I am instead referring to here is a Principal Investigator who has authority to make presentations for Sponsor. Dr. Halegoua is not one of these. These people have decades of experience in hepatology and extremely well compensated for this experience. They consult, lecture at all major pharma. They present at conferences, write articles in professional magazines. They sit on advisory boards of drug companies. They are key opinion leaders (KOL). They get equity ownership in drug company start ups. They have front row seat to see if drug works. While trials are double blind meaning neither investigator nor participant know if investigational drug participant takes is placebo or real drug, Principal Investigator has access to all data while regular investigator like mine will have access to data for the handful of participants that they have enrolled. My trial was supposed to enroll 2000 worldwide. As such a Principal Investigator is in a much better position to anticipate the end result of the trial. In no way am I suggesting that Principal Investigator knows who is on placebo.
A Principal Investigator can use this inside information to their advantage, taking ownership in the most promising stocks. When Allergan took over Tobira, Tobira stock increased 10 fold. It is all legal and some investigators report stock ownership. I think it should be law to require all doctors disclose stock ownership. If your investigator sold stock in company you are in clinical trial, you may want to rethink your participation. While I am not 100% sure I remember reading research hospitals are exempt from requirement for doctors to report stock ownership. If this is correct you want to go with research hospital that overrides that exemption and requires doctors to report such stock ownership. But this may explain why most investigators work in hospitals and not in for profit research companies where clinical trials business can bring 10 million annually. Researchers employed by major hospitals can still get 250K salary and have all free support provided by hospital. They bring lots of business to hospitals. This profession offers potentially great rewards and fame. I am guessing most investigators you encounter will strive to become someone who can participate in KOL events and reap all the benefits of this association.
Some doctors find themselves employed by biotech pharma and then start biotech companies, raise hundreds of millions in IPO (Initial Public Offering). Drug development takes decades while the company milks Wall Street for more money. Executives have pretty nice lifestyle at shareholder expense. Millions in compensation. And if drug actually works and approved, doctors can make billions. Not bad career path for someone who is not even 40. And who is helping her along? You. And what big biotech she already consults or sits on board? Gilead. And which medical doctor led division at Gilead and now CEO of biotech company with 2 billion market cap? It is CEO of NGM pharma
Again I have no idea what her plans are but everything she done so far pointing to one or all I described.
It is never about you. You, the participant, are just a tool to provide data. And as long as you understand this, you should never believe anything related to general trial info investigator tells you. You should always consider the source. I was told by someone on Dr. Halegoua’s staff how lucky I am to receive such good care from investigator and Galmed. What a lie it turned out to be. Read my Galmed post so you will see how well Galmed took care of me. I wish I never met Galmed or Halegoua or left Jefferson at the first sign of how they treat patients like garbage. And how can any Investigator become so well-known and so well compensated? By being loyal to sponsor because sponsors pays them and there are only handful of sponsors. NASH is epidemic and silent disease that can lead to liver failure and death. Any big hospital will have non ending supply of potential trial participants. All investigator staff needs is to look for elevated liver enzymes and few other things hospital already has to start qualifying someone for trial.
Does Dr. Halegoua-Demarzio want to become Principal Investigator? I have no idea. But she presented at liver conferences and publishes extensively in research publications. And where does she get data for her publications? From you. You are nothing more than a provider of data to investigators, sponsors, IRBs and FDA.
Dr. Dina Halegoua-Demarzio linkedin profile https://www.linkedin.com/in/dina-halegoua-b780739b states she is member Biopharma Physicians group network possibly this https://www.bpng.org/ Just another example that she appears to be about advancing her career as top priority and may be if she was spending less time on networking and more time reading informed consents for her Guinea pigs, I would not be writing this blog. Check your doctor linkedin profile, will tell you a lot about him/her
Dr. Halegoua, There is a good chance you are reading this. I noticed when I post a negative review about you on doctor review sites, immediately another 5 star review shows up from a person who never reviews anything. You may want to refresh your memory, you did not take The Hippocratic Oath such long time ago. You show pictures of yourself with 2 young sons. I know college is expensive but there is still way to make money and treat trial participants like human beings. Nothing wrong with making as much money as possible as long as it is not done at expense of old sick person like myself. On 1/26/2021 Galmed CEO Baharaff said publicly that he is unblinding all Phase 3 double blind participants. While you threw me out from Phase 3 a few days prior, if you have any decency please ask Baharaff to tell me if I was on the real drug because whatever I was on made me sick.
Dr. Halegoua-Demarzio Letter 1/19/2021
Dr. Halegoua-Demarzio Response to my complaint to PA Attorney General