In this entire ordeal, FDA surprised me the most. It is understandable Galmed will do what is best for Galmed and Galmed stock price. Investigator employed by Jefferson hospital has contract with Galmed and probably was told by Galmed not to provide any COVID accommodations for me. Investigator needs stream of sponsors such as Galmed to generate profit for her employer. FDA is expected to protect clinical trial participants but it turns out that FDA allows all this abuse. Besides usual reason such as pharma industry lobby, I think answer is quite simple. FDA employs over 15k and has budget of more than 3 billion. For that kind of taxpayer provided money FDA expected to produce results, meaning approve as many drugs as possible to benefit population. Why would FDA protect clinical trial participants if there so few of them and yet millions will benefit from their participation? Considering that clinical trial participants are volunteers that get few pennies thrown at them for expenses and considering that most who participate are poor and uneducated, FDA thinking probably they deserve everything they get for being so stupid.
So below is collection of this madness I discovered.
It was a huge surprise to me to learn that sponsors pretty much run entire show from time IND is approved until application for NDA is made. There is no such thing as permission from FDA to proceed from Phase 1 to Phase2 or Phase2 to Phase3 of clinical trial. There are thousands of patients involved in all phases of clinical trial and FDA is nowhere to be found in this process except negligible amount of audits.
So far everything I read that FDA recommends is non binding. This is why sponsors can get away with just about anything.
- My main concern was always FDA audits. How does FDA know that results submitted for approval are real results? Results are submitted directly by sponsor. While I still waiting answer to this question for over 6 months, this what I was told by FDA patient affair office
- Q: what percent of clinical trials get audited? is this percent higher or lower when sponsor is overseas?
- A: The FDA’s Office of Regulatory Affairs (ORA) conducts inspections of clinical trials through the Bioresearch Monitoring (BIMO Program) and may have information to answer these specific questions. The ORA’s web page is found at Office of Regulatory Affairs | FDA and includes information about how to contact the ORA. The FDA posts BIMO clinical trial inspection metrics by fiscal year on our web site at BIMO Inspection Metrics | FDA. The individual inspection metrics include a breakdown of both domestic and foreign inspections conducted that may be helpful to help address these particular questions.
- It is unlikely I will ever get percentages, but if you enter recurring on clinicaltrials.gov you get over 50,000 trials, numbers in these links above go into few hundreds so I say chances to get audited are very slim.
- As far as providing information for trial participant to make informed decision, this is what I got from patient affairs
- Q: is providing patent expiration that is very near expiration in trial sponsor conducting should be part of informed consent?
- A: The FDA informed consent regulations do not have a requirement to include sponsor patent information.
- Every clinical trial listed on clinicaltrials.gov requires to answer if Data monitoring committee (DMC) is established.
- But YOU AS TRIAL PARTICIPANT NOT ALLOWED TO KNOW IF THERE IS SUCH COMITTEE.From patient affairs:
- Q: should providing DMC name be part of informed consent?
- A: The FDA informed consent regulations do not have a requirement for including the name of a Data Monitoring Committee (DMC) if the sponsor has established a DMC for a study.
So let’s say you decided to enroll in study based on the assertion on clinicaltrials.gov that a Data Monitoring Committee is employed by Sponsor. DMC is authorized to stop the trial if some investigator reports serious adverse effect. But you have no way of knowing if DMC is actually employed by sponsor other than the unverified assertion. IRB, Investigator, Sponsor at best will respond that such information is confidential. Participant is at the mercy of the DMC (if it exists) or Investigator and Sponsor that SAE (Serious Adverse Effect that could be death), will give the participant welfare priority over the financial loss to Sponsor / Investigator.
And lastly another reply from patient affairs regarding liability insurance
- Q: is liability insurance sponsor claiming to hold in informed consent mandatory in US?
- A: The FDA informed consent regulations do not have a requirement for including information on liability insurance, if held by the sponsor.
- Q. I understand that sponsor can conduct clinical trial without IND (Investigational New Drug) approval. But how can participant of clinical trial obtain such IND?
- A. Sponsors of IND applications may obtain advice and guidance from FDA at any stage of IND development. A sponsor may consult with the Agency before formal submission of an IND application and send a pre-IND meeting request (PDF – 145KB) to an appropriate Review Division responsible for overseeing products in the therapeutic area relevant to the IND application.
Please note that due to confidentiality laws, the FDA cannot divulge information related to applications that may or may not have been submitted to the Agency. All information on an unapproved drug product is confidential and belongs to the sponsor. Individual researchers may be able to provide you additional information on their specific study or studies, and information may also be available through clinicaltrials.gov
My interpretation: So good luck getting copy of that IND
So you may wonder FDA does not require anything, how it is possible?
- My most painful discovery came from fact that FDA does not enforce it is own laws. So how does a Sponsor induce Investigators to recommend their trial to a prospective participant? Sponsors publish results in professional magazines, fly investigators to conferences where results presented. But most sponsors will never publish results on clinicaltrials.gov. and when investigator promises you results will be published, it is most likely a lie to entice you in a trial. Here is http://fdaaa.trialstracker.net/ there is existing law passed in 2007 and not single fine imposed by FDA. If you interested in trial put sponsor name in search box and you will see how many years they are late in reporting results. Why this is dangerous for patients considering enrolling in clinical trials with non complying sponsors? I suggest you google everything that site founder Dr. Ben Goldacre wrote including FAQ on his site. Sponsors have no excuse for not reporting results, Dr. Goldacre explains it so well. But if you are a sponsor and you know you never going to pay single dollar in fines, why spend few dollars preparing and reporting these results? It is a lot easier to prepare some marketing materials to distribute to investigators. This is probably the only time you as patient have any leverage. If you decline to participate in a trial unless results are reported on clinicaltrials.gov, investigator will stop returning your emails, but if enough people will say it may be things will change. Or you can do homework and find ethical sponsor such as Pfizer.
Writing to your elected officials and asking for change as Dr. Goldacre recommends is waste of time. How exactly your congressman or senator can force FDA to enforce existing laws? It is all by design and your elected official has plenty of contributions from pharma lobby. In fact I was told by my senator office that they don’t get involve with FDA.
- It is question you need to answer for yourself. Do I want to be in a trial with zero transparency that will possibly endanger my life and nobody is going to be there to treat me if I get sick from investigational drug or provide for my family if I die from it? The way things stand right now my answer is no. You can try to ask for changes in informed consent to make it not totally one sided in favor of Sponsor or Investigator. You can try to negotiate for more money for trial visits. Ask Investigator to show contract provided by Sponsor. How much money Investigator gets for pushing paperwork around and telling you ½ truths while you endangering your life?
- While I don’t have access to Dr. Dina Halegoua-Demarzio contract with Galmed I found contracts Galmed possibly signed 7 years ago with another research institution. Look towards bottom of link below. Stunning amount of money goes to investigators. At least 600k just to one institution for one trial https://www.lawinsider.com/contracts/6blm94lWrmJY2jxAhPBIXy/galmed-pharmaceuticals-ltd/clinical-trial-agreement/2015-03-31
If you ever want to get information out of FDA, you have to do FOIA requests and you have to pay for that. And any requests asking for information for unapproved drugs will get automatically denied.
If you ever file complaint with FDA don’t expect any response as far as resolution. Maybe you can do Freedom Of Information Act (FOIA) requests to see what they decided if anything. Most likely waste of time. FDA will invariably put Sponsor’s interest first and zero consideration for participant.
There are number of contact emails for FDA and someone needs manual to understand who does what.
Below few email addresses if you inclined to verify if it is really that bad.
- patientaffairs@fda.hhs.gov that is the only email to get any response.
- OHRP@hhs.gov office of human protection, but only gets involved with NIH sponsored trials. Most of trials are from drug companies. So don’t expect to be treat as human
- CDER-OSI-GCPReferrals@fda.hhs.gov that is email to submit useless complaint that you will never hear back.
What do I think about FDA role in clinical trials after I learned everything is to learn? It looks like most of things FDA does is honor system. Ask the hundreds of patients who participated in Phase 3 Fibrogen trial how honor system turned out for them. As Phase 3 was completed right before approval of NDA, FDA asked for advisory committee. On 4/6/2021 the company admitted not reporting correct safety results to FDA. Where things can end up when someone know they can get away with it?
Everything is based on very small percent of audits. And what exactly happens is audit fails? Especially in foreign country? Especially in country that does not extradite it citizens to US? Does FDA even reports offenders to foreign authorities?
So when I read story like this I am not even surprised.
There is no better example than 510 (K) loophole for medical devices that was enacted by congress to allow FDA to do what outlined in this video. https://www.youtube.com/watch?v=-tIdzNlExrw or in this article https://www.greenlight.guru/blog/fda-clearance-approval-granted
FDA lists approved devices for each year https://www.fda.gov/medical-devices/recently-approved-devices/2021-device-approvals
Here is list for FDA cleared devices so you may want to know to how dangerous they could be. https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2021
FDA is nothing more than huge bureaucracy that owned by lobbyists. After everything I learn about clinical trials it feels like FDA is fully owned subsidiary of Citizens United, llc. Corporation are people according to former presidential candidate, looks like FDA protects these kind of people before real people. Sometimes FDA does right thing and asks for advisory panel such as panel that was created with covid vaccines. Or rejects Intercept drug that did very little in fibrosis reduction and had serious side effects. But overall it feels totally hopeless as far as FDA protecting trial participants. But no matter who you vote for that will never change. You the volunteer, and drug industry needs you for clinical trials a lot more than you need them.
Don’t even think complaining to IRB. They approve useless informed consent and sponsor pays them and FDA rules what suppose to be in informed consent are simply laughable. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50 and non binding
And how do you know purity of investigational drug? Ask your investigator, sponsor suppose to disclose purity. And if you happened to be on placebo (obviously you would not know what you on), FDA does not regulate contents of placebo. Don’t assume you could be on harmless sugar pill. https://www.motherjones.com/politics/2010/10/placebo-ingredients-drug-trials/ demand to know purity contents, and where it is made. My bottles showed manufacturing company with headquarters in Germany but didn’t say “made in Germany”. Company has facilities worldwide. I don’t want a drug manufactured in China. Their U.S. facility has glassdoor complaints about quality control. I am entitled to know where the drug is made.
I am victim with millions of Americans who took generic blood pressure medication manufactured in China with Chinese government requirement only to inspect factories by advanced appointment. The result of this compliancy on behalf of FDA cancer causing compound https://www.webmd.com/hypertension-high-blood-pressure/valsartan-losatran-bp-med-recalls-2018-19
If you think my experience is unique because Galmed is small company following is list of email addresses I asked trial specific questions:
I got no help from them, whole system designed to send you to investigator who will peddle you stuff according to their interests not what is best trial for you. Patient advocacy? Does not exist. Any Google searches will point to websites created by drug companies with videos of happy trial participants (aka guinea pigs) promoting this multi billion dollar industry. And main partner in this is FDA which on paper looks great with all this documentation what Informed Consent should be but in reality Informed Consent Galmed created for me and approved by Investigator and IRB was designed to keep me in the dark.
I am not saying stay away from clinical trials. All I am advocating is for disclosure what I am risking my life for by taking investigational drug. And for FDA to protect trial participants and protect integrity of data submitted to FDA and to enforce existing laws and to stop this bs of notifying foreign drug company/lab/drug manufacturing plant by email, giving them advance warning we are showing up on such date and time. If some foreign country by law requires FDA to do that, FDA has power to tell said country to keep drugs developed or manufactured in this country for their own citizens.
And if you read in informed consent that you have legal rights, that is fantasy. You are volunteer, you signed informed consent that 100% on side of sponsor, investigator and IRB. Consent is legal, you have no case if you decide to sue any of these 3 entities. Unless they breached the informed consent, you have nothing. Withholding material information is legal. One sided informed consent is legal. But even if you are able to prove breach of contract, good luck finding lawyer to represent you. Lawyers represent investigators, IRBs and sponsors. Representing you will be conflict of interest. I am not giving you legal advice, but time to look for one is before you sign that consent. I contacted numerous lawyers in order to attempt legal action. Most did not respond and those that did said they could not represent me due to conflict of interest.
In conclusion I am wondering what exactly taxpayers getting for this 3 billion annual budget. Not much in my opinion except providing employment to huge bureaucracy. And fact that it is impossible to get straight answer from that bureaucracy must be by design. My senator office told me from outset they don’t get involved with FDA. With tiny amount of audits it looks like drug approval process is simply honor system. FDA does not enforce laws to fine sponsors for not disclosing trial results. Is not this gift to drug companies and grave danger to trial participants? Fact that liability insurance not required for participants is gift to tort lawyers. FDA clearance with 510k loophole is sad joke. Even if company wanted to get approval presumably by paying more for process FDA would not allow it.
Food? Dangerous metals in baby food tells you all you need to know.
Not inspecting Chinese plants that manufacture drugs? Gift to generic companies.
And if you say is not this the way government agency supposed to work? Why this is different from 1.5 trillion wasted on failed f-35 jet? If FDA did not hurt you in any way I guess it is ok, but when human lives involved we US taxpayers deserve better FDA.
NASH Patients Clinical Trial Exchange 
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