#fda investigator

[ccrpsorg]

An In-Depth Guide to Form FDA 1572

What is the Form FDA 1572?

The Form FDA 1572 is a form issued by the United States Food and Drug Administration (FDA). It is a document that must be completed and submitted by sponsors and investigators conducting clinical trials in the United States. This form provides the FDA with important information about the clinical trial, such as the protocol, investigator qualifications, and other important information.

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

Who is Required to Complete the Form FDA 1572?

The Form FDA 1572 must be completed and submitted by sponsors and investigators involved in clinical trials conducted in the United States. The sponsor is the organization that is responsible for the conduct of the clinical trial, and the investigator is the individual responsible for the conduct of the trial at a specific site.

How to Complete the Form FDA 1572?

Completing the Form FDA 1572 can be a daunting task for investigators and sponsors. However, it is important to understand the information requested on the form, as well as how to accurately and completely fill out the form. A few tips for completing the form include: thoroughly reviewing the instructions before filling out the form, carefully reading each item on the form and providing complete and accurate information, and providing all required information, such as signatures and dates.

Steps to Filling out FDA 1572 Form:

Write the name of the investigator at the top of the form. For example, enter “John Smith” as the Investigator Name.

Enter the address of the investigator in the next line. For example, enter “123 Main Street, Anytown, USA 12345” as the Investigator Address.

Enter a phone number for contact purposes in either a local or international format (e.g., “1-800-555-1234” or “[phone]”).

Enter a valid email address associated with the investigator in the provided field (e.g., [email protected]).

List any previous investigational drug and device studies that have been performed by this investigator under FDA oversight (if applicable). For example, enter “CT-001, DB-002” as Previous Investigational Studies Conducted Under FDA Oversight.

Indicate whether you are requesting approval to conduct clinical trials with drugs or devices by checking one of two boxes: Drugs or Devices/Biologics/Medical Devices/Other Products Regulated by FDA (e.g., select “Drugs” if you are requesting approval for clinical trials with drugs).

Follow up with information about which specific drugs or devices will be used in your studies (e.g., enter “Lipitor, Celebrex” for drugs and/or “Defibrillator XF7500, Pacemaker YZ2300” for medical devices).

Specify how many new indications or dose regimens you will be studying with each drug or device (e.g., enter 2 for Lipitor and 1 for Celebrex).

Provide details about any preclinical studies conducted to evaluate safety and efficacy data related to your proposed clinical trial (if applicable; e.g., provide details about animal models used and results obtained from these tests)

Describe any other research activities related to FDA product regulation that have been conducted by yourself or associates at your organization (if applicable; e.g., enter “Phase II safety study on Lipitor conducted in 2018”)

Sign and date the form after carefully reviewing all information entered into it

FAQs for Form FDA 1572

What is the Statement of Investigator, Form FDA 1572?

The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND). It is used to provide information about the qualifications of investigators conducting studies with investigational drugs.

Why does this form need to be completed by an investigator?

This form needs to be completed by an investigator to ensure that they are qualified and have the necessary experience and expertise to conduct a safe and ethical clinical trial. This form also serves as affirmation from the investigator that he or she has read and understood the protocol of the clinical investigation in question, as well as any other information pertinent to the study provided by the sponsor or sponsor-investigator.

When must this form be completed and signed by an investigator?

The form must be completed and signed by an investigator at or before initiation of a clinical investigation which involves use of an investigational drug. The form must also be updated or a new 1572 must be completed and signed by an investigator if there is new or changed information relevant to the study.

Must the investigator be a physician? What are the minimum qualifications of an investigator?

An investigator does not need to be a physician, but should meet certain criteria set forth by FDA such as having sufficient training, knowledge, and experience pertinent to the type of research being conducted; having access to medical records relevant to studies being conducted; understanding good clinical practice requirements; following protocols; and obtaining informed consent from research participants.

Does the 1572 need to be submitted to FDA?

Yes, this form needs to be submitted to FDA along with supporting documents prior to initiation of a clinical trial involving use of an investigational drug. Even if a foreign clinical study is not conducted under an IND, investigators who conduct such studies still may need to sign a 1572 in certain circumstances.

If a clinical investigation is not conducted under an IND or is for a medical device, must investigators sign a 1572?

A sponsor may conduct a foreign clinical study under an IND only in situations where it does not qualify for exemption from IND regulations due to lack of assurance that subject protection will be maintained without oversight from FDA. If such conditions are met then sponsors must submit an IND application prior initiating the foreign study in order for it to comply with applicable regulations.

Must investigators who conduct studies outside of the United States sign a 1572?

Yes, according to the Food and Drug Administration (FDA), all clinical investigators conducting studies on FDA-regulated products that require an Investigational New Drug (IND) application must sign a Form FDA 1572. This form is used to confirm that the investigator understands their obligations and responsibilities related to conducting IND-related studies.

If a foreign clinical study is being conducted under an IND, what are the investigator's responsibilities with respect to local laws and regulations?

When conducting foreign clinical trials under an IND, investigators must comply with both local laws/regulations as well as those set forth by the FDA in 21 CFR Part 312. This includes ensuring that good clinical practice standards are followed and that any applicable ethical considerations are taken into account when designing and implementing the study protocol. In order to ensure compliance with local laws, investigators may need to obtain permission from national or regional regulatory authorities before beginning the trial. Additionally, depending on the country in which a foreign clinical trial is conducted, additional requirements such as language translations of informed consent forms may be necessary.

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when he/she knows he/she cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107)?

In order for an investigator to sign a Form FDA 1572 for a foreign clinical study under an IND even if they know they cannot commit to all of its requirements (specifically IRB membership), they should discuss this issue with their sponsor prior to signing it in order to find out what alternative arrangements can be made. Furthermore, sponsors should consider both local laws/regulations as well as ICH standards when making these arrangements so that appropriate safety measures can be taken. For instance, sponsors may choose to contract independent consultants or external experts who are familiar with good clinical practice standards in order to review data gathered during trial activities at sites located outside of United States jurisdiction.

If a sponsor chooses to conduct a foreign clinical study (or operate non-US sites in a multinational study) under an IND and the investigators at these non-US sites comply with ICH E6 Good Clinical Practice Consolidated Guidance, would the non-US investigators also be in compliance with FDA's IND requirements under 21 CFR Part 312?

When conducting foreign clinical trials under an IND, compliance with ICH E6 Good Clinical Practice Consolidated Guidance alone may not guarantee full compliance with 21 CFR Part 312 requirements set by the FDA. Although ICH standards provide general guidance on how research should be conducted ethically and safely within different jurisdictions around world, some countries have rules or regulations in place which differs from those established by ICH E6 Good Clinical Practice Consolidated Guidance or which might amend them slightly; therefore potential discrepancies between these two sets of regulations need to be taken into consideration when designing trial protocols for international trials subject to FDA jurisdiction. Furthermore, sponsors should ensure that all parties involved in such trials understand their individual responsibilities related executing Research Ethics Committee approval processes required for each country included in study protocol design prior commencing trial activities at each site outside US jurisdiction

Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

Yes, all foreign clinical study sites that are part of a multinational study must be conducted under an IND. The sponsor must submit an application to the FDA for approval to conduct the study and provide detailed information about the site, such as personnel qualifications, resources and facilities available at the site, and protocol for conducting the research. The IND application includes protocols and other information describing how a proposed clinical investigation will be conducted.

How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

The sponsor must submit an Investigational New Drug (IND) Application to the FDA if they wish to conduct a foreign clinical study which has not been previously approved by the FDA. The sponsor should include detailed information regarding the proposed clinical trial, including the proposed protocol, safety measures put in place to protect subjects participating in the trial, qualifications of personnel involved in conducting or supervising the trial, and any other information which will help demonstrate compliance with applicable regulations.

Should a new form be prepared and signed when the OMB expiration date is reached?

No, there is no need for sponsors to prepare or sign any new forms when submitting an Investigational New Drug (IND) Application or when seeking approval from FDA for any particular clinical trial. However, sponsors must follow all applicable laws and regulations related to their research activities and comply with requirements set forth in relevant documents such as Form 1572 (Declaration for Clinical Investigations Involving Human Subjects), Form 3454 (Statement of Investigator), and Form 3753A (Clinical Investigator's Brochure).

Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable?

The FDA requires sponsors to submit Form 1572 as part of their IND application as both single-sided copies and double-sided copies. The form should be completed according to applicable regulations outlined by 21 CFR 312.23(a)(7). Sponsors may not use double-sided copies of documents obtained from websites hosted by other organizations, including those belonging to different government agencies or non-profit institutions..

How should the 1572 be completed?

Form 1572 should be filled out completely by each investigator listed on it who is responsible for conducting or supervising certain aspects of research activities at any given site. This includes providing all necessary details such as person’s name, address/location(s), contact information (e-mail address/phone number/fax number etc.), signature(s) etc., along with listing any degrees/licenses held by him/her that show he/she is qualified to conduct/oversee said research activities being funded through this particular project. Furthermore important section detailing ‘Financial Disclosure’ needs special attention especially since this form also serves purpose of informing potential participants about potential conflicts of interest pertaining to investigator’s involvement in these studies alongside his/her salary details etc. So it is crucial that this section is filled out completely without leaving out any significant details so that true picture can be presented in front of future volunteers who might decide whether they want participate in said studies or not based on aforementioned disclosure

Review Questions for FDA Form 1572

What is FDA Form 1572?

A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued

B) A form that must be completed by all patients participating in a study

C) A document used to report adverse drug events to the FDA

D) A document used to collect information about the safety and effectiveness of drugs

Answer: A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued. Explanation: The FDA Form 1572 is an agreement between investigational sites and the FDA. It outlines key elements of studies conducted at those sites such as background qualifications of investigators and staff, source documents, records maintenance, reporting requirements and procedures for handling drugs used in clinical trials.

What type of information must be provided when completing FDA Form 1572?

A) Personal information about each individual participant in a trial

B) Information about drugs being tested in a trial

C) Financial information from sponsors involved in the trial

D) Information about laboratory tests performed during the trial

Answer: B) Information about drugs being tested in a trial. Explanation: The FDA Form 1572 requires that the investigator identify all drugs to be administered during the investigation (e.g., active ingredient names and doses), along with any other products that may affect laboratory results such as vitamins or minerals. This will help ensure accurate record keeping throughout the trial.

Who is responsible for ensuring accuracy on FDA Form 1572?

A) The clinical investigator conducting the study

B) The sponsor of the study/trial

C) The patient participating in the study/trial

D) All of the above

Answer: D). All of the Above. Explanation: Accuracy on FDA Form 1572 is essential since it serves as an agreement between investigational sites and the Food & Drug Administration (FDA). Thus, both sponsors and clinical investigators are responsible for ensuring accuracy on this form, as well as patients who participate in studies/trials should they provide any data or information required by this form.

When does an individual need to submit an updated version of FDA Form 1572?

A) When enrolling new patients into a clinical trial

B) When changes are made to protocols related to a given clinical trial

C ) When making changes to personnel associated with a given clinical trial

D ) All of the above

Answer: D). All of the Above Explanation: An updated version of FDA Form 1572 needs to be submitted when enrolling new patients into a given trial; when changes are made to protocols related; or when personnel associated with a given clinical trail have changed since its initiation or last update. This helps ensure accuracy so that all parties involved have access up-to-date information regarding ongoing studies/trials they’re involved with at any given time.

What happens if an individual fails to submit an updated version of FDA Form 1572?

A ) They will not receive funding for their research project

B ) Their research project may not pass inspection from regulatory authorities

C ) They may face legal repercussions from regulatory authorities

D ) All of the Above

Answer: D). All of The Above Explanation: If an individual fails to submit an updated version of FDA Form 1572 then they can face various consequences such as not receiving necessary funding for their research project; having their research project fail inspection upon review by regulatory authorities; or facing legal repercussions from said authorities due its importance in providing complete documentation related to ongoing studies/trials involving human subjects which helps protect participants’ rights while conducting necessary research work safely and ethically within regulatory guidelines set forth by law enforcement bodies responsible for protecting public health around world according these standards set forth through years long process establishing best practices medical community has come accept today across many countries globally depending respective jurisdiction laws apply under question particular case being consider review possible action taken based findings presented within scope parameters policy established maintain highest ethical standard ensure well-being everyone involved

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

#fda full name #fda form 1572 #1572 form fda #match the following statements with the appropriate tissue sample. #1572a #fda form 3455 #clinical forms #fda form #conducting investigator-initiated studies according to fda regulations and gcp #fda form 3674 #1572 fda guidance #fda guidance on 1572 #1572 template #form 1572 fda #1572 #fda forms #conducting investigator initiated studies according to fda regulations and gcp #fda 3455 form #form fda 3454 #fda investigator #nursing task #fda 1572 statement of investigator #fda clinical trial #1572 form #1572 fda #fda 1572 guidance #dd quiz #when must the investigator update the irb #fda form 3454 #fda1572

[ghoulishautism]

The concept of ghost aging and reproduction still confuses the hell out of me, though I think ghost aging is somehow far more confusing

Because if ghosts are the plasma energy of spirits (few which may have never been human/fully human in the first place) then yeah, sure. I guess if they can shapeshift to some degree, they can make themselves appear younger/older (whether intentionally or because of their current 'emotional state'), but that still leaves me with a LOT of questions!

Do ghosts age normally through the passage of time, or is it purely dependent on their mental/emotional age? (like Youngblood staying young while Ember hits middle age during TUE's bad future)

Can ghosts revert back to a younger emotional/mental state and have their appearance reflect that? (Clockwork technically changes age constantly, but hes also a literal Time God)

Does time pass the same way in The ghost Zone as it does on Earth, or does it vary between/doesn't move at all? (The GZ doesn't have any celestial bodies so I don't know how they'd measure time anyway)

How does ghost reproduction......work?

Actually nevermind I dont think I want to know the details regarding Box Lunch's 'delivery'.

#danny phantom #dp lore #i shouldnt think too hard about this but at the same time. Its the one thing about TUE that still gets me #Aside from the death sauce that should have been investigated by the FDA a while ago

[is-the-owl-video-cute]

you really admitted to feeding your pet Rachel Ray brand while discouraging people from using vet approved brands huh

Yes, anon. Because that is the food my veterinarian recommended for my dogs, you ninny.

this is what I feed my dogs, again, something discussed with my vet, who I would imagine knows more about pet nutrition than you do.

#This isn’t even a good roast because Rachael ray isn’t a scandalous dog food #it was one of like 50 brands with dog food the fda investigated the grain free diets for something that could cause DCM #but the fda couldn’t decisively link the DCM cases to food at all let alone any food in particular #and I can’t stress enough that I don’t even feed grain free to my animals so this isn’t even relevant #shocking: dog food company makes more than one line of dog food #and the only recall on this brand was for specific flavors of wet cat food in ~2015 or so? Iirc #which. as stated in the post. my cats don’t eat Rachael ray #my dogs do #supplemented with other canned food #¯\_(ツ)_/¯ #again #my cats eat a prescribed Royal canin and 4health #Stay mad about it though I guess #Purina has had SEVERAL RECALLS AND LAWSUITS FOR THE RECORD #but sure we can pretend they get a gold star #hills had to recall 30+ food lines because they had enough vitamin D to kill pets and this was just in 2021 #can we stop acting like the ~vet approved~ brands are any better than any of the rest

[didanawisgi]

#Sharyl Attkisson #covid-19 vaccine #covid-19 #investigative journalism #FDA #government #censorship #ivermectin

[aci25]

How Americans Are Tricked Into Buying Fake Food

The food in your kitchen cabinets may not be what it seems. Fraudsters motivated by economic gain secretly infiltrate the global food market through a variety of means, including counterfeits, dilutions, substitution and mislabeling, according to the Global Food Safety Initiative. This may not only harm consumers’ wallets, but it can also put public health and safety at risk. Some estimates say food fraud affects at least 1% of the global food industry at a cost as high as $40 billion a year, according to the FDA.

I used to work in a food production factory here in the US, and we were inspected by the FDA annually. There were two things I always found surprising. #1: I feel like the inspection done by the FDA is not thorough enough, meaning that things swept under the rug by management could easily be overlooked. #2: The hourly employees in my plant, especially those with extensive tenure, saw all the bull$hit that management pulled and corners that were cut. Yet when the FDA came in, there were things that got swept under the rug and the FDA inspectors missed things happening right under their noses. In addition, management followed the inspector around the facility everywhere they went, to make sure us hourly employees remained silent. When an FDA inspector did ask an hourly employee questions, management was right there ready to give us a stern look if we were about to say anything that stepped out of line, even if it was the truth. You can bet your @ss  that future employment and promotions within the company were automatically off the table if you spoke up. It makes me wonder if this happens in the place I worked at before, then it must be happening all over the country. We really DON'T know what's going on inside of our food production facilities, and we don't know exactly how our food is handled, or what exactly is put in it. Bottom line, I will never trust the FDA, and if I can't trust the FDA then I don't trust the government either.

#youtube #How Americans Are Tricked Into Buying Fake Food #fda corruption #fda approval #fake food #your health #food investigation #this is usa #the food industry #food fraud #food fraud economy #united states

[lillybean730]

im trying to decide if the risk of falling ill is worth it bc i want cheerio now

#apparently some people have been getting stomach problems from it but like #it's all anecdotal and the fda isn't investigating afaik #fuck it cheerio time

[thejewishlink]

FDA investigated more baby deaths related to Abbott plant than previously known: report

FDA investigated more baby deaths related to Abbott plant than previously known: report

A nationwide formula shortage was linked to the Abbott plant’s closure By Julia Musto   FOXBusiness The Food and Drug Administration (FDA) reportedly investigated seven more child deaths due to the consumption of contaminated baby formula from the Michigan Abbott Nutrition plant than was previously known. The Washington Post, citing newly released documents, said that the agency investigated…

View On WordPress

#Abbott Plant #Baby Deaths #Baby Formula #FDA Investigation

[mindblowingscience]

Could the sweetened drinks we're consuming be making us feel a little more anxious? A 2022 study looking at the effects of the artificial sweetener aspartame on mice suggests that it's a possibility that's worth investigating further. Approved by the US Food and Drug Administration (FDA) in 1981, aspartame is widely used in low-calorie foods and drinks. Today, it's found in nearly 5,000 different products, consumed by adults and children.

Continue Reading.

#Science #Health #Neuroscience #Anxiety #Diet #Sweetener #Aspartame

[mostlysignssomeportents]

Monopolizing turds

Update 31 May 2023: an earlier edition of this article identified the price of Rebyota as $20,000; this was the rumored price prior to Rebyota’s release in December  2022, when Stephen Skolnick wrote the article I referenced. When Rebyota was actually released in 2023, the average wholesale price (AWP) was $10,800. Thanks to Benjamin Jolley for catching this error, and to Stephen Skolnick for getting to the bottom of it.

It’s been ten years — to the day! — since I first started writing about the bizarre, amazing world of turd transplants, in which a sick person receives a microbiotic infusion in the form of some processed poop from a healthy person:

https://web.archive.org/web/20130608030455/http://blogs.plos.org/publichealth/2013/05/29/why-diy-fecal-transplants-are-a-thing-and-the-fda-is-only-part-of-the-reason/

Gut biomes are one of those understudied, poorly understood medical areas that are both very promising and also full of sketchy medical claims from “supplement” companies, influencers, quacks and grifters. But in the decade since I first started tracking turd transplants (formally called “Fecal Microbiota Transplants” or FMTs), a growing body of sound science has emerged on the subject.

One thing that’s increasingly undeniable is that the composition of your microbial nation is related in significant ways to both your physical and mental health. What’s more, as antibiotic resistant “super bugs” proliferate, FMTs are becoming increasingly central to treating dangerous gut infections that otherwise stand a high chance of killing you.

“Eat Shit and Prosper” is Stephen Skolnick’s delightfully named newsletter about poop and health science. Skolnick is a physicist by training, but has a long history of collaboration with Openbiome, a nonprofit that coordinates between doctors, patients and donors to provide safe FMTs:

https://stephenskolnick.substack.com/

In an edition of Eat Shit from last December, Skolnick recounts the amazing history and dismaying future of FMTs. In 2013, the FDA announced it would regulate FMTs as “Investigational New Drugs,” which could only be administered as part of a registered clinical trial:

https://stephenskolnick.substack.com/p/a-monopoly-on-poop

At that point, FMTs were already in widespread use by docs to treat otherwise untreatable cases of Clostridioides difficile (C. diff), an antibiotic resistant bacterial infection that literally makes you shit yourself to death. These doctors were in no position to run registered clinical trials, which meant that they would have to stop using the most effective therapy they had for a potentially lethal infection.

Doctors and patients kicked up a fuss, and the FDA walked back its guidance, announcing that it would exercise “discretion” in enforcing its Investigational New Drug rule, giving a pass to docs who were treating C. diff with FMTs:

https://www.federalregister.gov/documents/2013/07/18/2013-17223/guidance-for-industry-enforcement-policy-regarding-investigational-new-drug-requirements-for-use-of

That’s where things have stood for the past decade or so. The “discretion” rule means that patients could still get FMTs, but their insurance wouldn’t cover it. But even if you had cash to pay for an FMT, your doc probably wouldn’t administer it for anything except a C. diff infection, despite the promising signs that FMT can help treat other conditions, and despite the generally safe nature of FMTs.

If your doc did give you an FMT, chances are good that they sourced their poop from Openbiome. Openbiome recruits very healthy people, gets them to poop in a bag, then processes the poop — removing nonbacterial solids, testing it for pathogens, freezing it, portioning it, and sending it to docs. All this is done at cost, and it’s not cheap: $1–2k/treatment, mostly due to cold-chain logistics (the poop is shipped at -80C).

Despite the cost, and despite the limitations on treatment, the Openbiome method has proved very reliable. Indeed, FMTs as a whole are pretty darned safe, with the most common side-effects being transient gas and bloating. In the past decade, there’ve been a total of six “adverse effects” associated with Openbiome’s 5,000+ procedures, all in severely immunocompromised people, and none conclusively linked to the treatment:

https://www.sciencedirect.com/science/article/pii/S0016508522003511/pdf

A decade into this system, the FDA has taken the next step forward — only it’s actually a step backwards.

During this intervening decade, a pharma company called Ferring has conducted clinical trials on FMTs and received approval for an FMT product called Rebyota. The process for making Rebyota is effectively identical to the process used by Openbiome: collect poop, remove solids, test for pathogens, add glycerol, freeze and ship.

The main difference between Rebyota and Openbiome’s poop is price. While Openbiome charges $1–2k per treatment, Rebyota charges $10,800

That’s some expensive shit!

Fine. Getting Rebyota through clinical trials means that insurers might start covering it, and perhaps some patients will prefer brand-name poop to open-source poop. But as part of the FDA’s approval of Rebyota, the agency also rescinded its “discretionary enforcement” guidance, making it illegal for docs to source their poop from Openbiome:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-regarding-investigational-new-drug-requirements-use-fecal-microbiota

For Ferring, this is a monopoly on shit, one that lets them charge patients $10.8k for poop that costs $1–2k to process. The FDA does not claim that this is being done in the name of safety. Instead, an FDA official told Skonick that the goal was to “incentivize innovation without creating an access crisis.”

That is, the FDA changed its guidance and put nonprofit stool banks out of business because it wants to incentivize pharma companies to perform expensive clinical trials, and it believes that these companies won’t pay for trials if they have to compete with the likes of Openbiome, which would make it impossible to charge 900% markups on poop.

Trials are important! Evidence-based medicine is important! But Ferring’s clinical trials didn’t tell us anything we didn’t already know. FMTs were already the best therapy we had for C. diff. Testing Rebyota against a placebo didn’t tell us anything new — unlike testing Rebyota against the existing therapies, e.g. product from open stool banks.

Such a trial might have given rise to a very different regulatory outcome, because the cure rate reported by Rebyota is much lower than the cure rate from Openbiome’s own interventions:

https://link.springer.com/article/10.1007/s40265-022-01797-x

That is, using the $1k poop from Openbiome seems to be much more effective than using the $10.8k poop from Ferring. But Openbiome, a nonprofit, hasn’t been able to perform the kind of rigorous — and expensive — clinical trial that Ferring funded.

This points to a significant problem with the FDA’s model. The agency wants good clinical data for the medicines it regulates, as it should, It presumes that the only way to get that data is through granting commercial exclusivity to a for-profit, which ends up costing patients vast sums, and locking many patients out altogether.

This creates all kinds of new dangers. 150,000 people/year in the US contract Recurrent Clostridium difficile Infection (RCdI). FMT increases the cure rate by 20% relative to antibiotics alone. That means that if everyone with RCdI gets a poop transplant, 30,000 extra people will get better. That’s a big number!

For well insured people, Rebyota probably represents a cash-savings — if your insurance covers the $10,800 procedure, you might pay $500 out of pocket, which is far less than the $1–2K you’d pay to get an Openbiome poop transplant. But if you’re uninsured or underinsured, the FDA’s new enforcement rules mean that you’re now on the hook for $10,800.

The FDA did carve out a loophole: if your doc or their hospital are willing to prepare the poop transplant themselves, they can administer that. On the one hand, preparing a poop transplant isn’t that hard — some people do them at home, on their own:

https://web.archive.org/web/20211015060558/https://thepowerofpoop.com/epatients/fecal-transplant-instructions/

But on the other hand, there’s been exactly one death conclusively linked to FMT, and it was from one of these hospital-prepared transplants (the patient had just had a marrow transplant for cancer that wiped out their immune system, and the donor had a novel pathogen that the hospital failed to test for).

So the FDA has created a situation where, if you can’t afford a $10,800 proprietary formulation, your only option is to convince your doc or hospital to prepare their own poop transplant, which will cost less than the $10.8k for Rebyota, but more than the $1–2k from Openbiome, which has all kinds of economies of scale. And if you do manage it, you’ll be getting a procedure that has a much worse safety track-record than the Openbiome process that the FDA just killed.

The FDA has an important role to play here, but as with so many policy questions, how the FDA plays that role depends on things that are far upstream from the agency and its decisions. The choice to fund medical trials through the promise of exclusivity — and with it, extremely high margins — puts the FDA in the position of choosing winners in the marketplace: Ferring wins, Openbiome loses.

Ironically, this is the thing that exclusivity is supposed to prevent. By using profit to incentivize medical research, the FDA is supposed to be recruiting the Invisible Hand as its partner in regulation. But exclusivity is incompatible with the idea of medicine as a public good. The tens (hundreds) of millions that Americans will pay for $10.8k poop transplants from Ferring will add up to far more than it would cost to underwrite clinical trials for an open process like Openbiome’s.

The result: both Americans’ wallets and Americans’ guts suffer.

Catch me on tour with Red Team Blues in Hay-on-Wye, Oxford, Manchester, Nottingham, London, and Berlin!

If you’d like an essay-formatted version of this post to read or share, here’s a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2023/05/29/oh-shit/#rebyota

[Image ID: A poop emoji wearing a top hat and a monocle, posed against a backdrop of e coli bacteria seen through a high-resolution microscope.]

#pluralistic #stool bank #eat shit and live #pharma #fda #regulatory capture #fecal transplants #microbiomes #rebyota #openbiome #c diff #fmt #fecal microbiota transplant

[didanawisgi]

A top federal official in charge of evaluating the safety of drugs was hospitalized against his will this month for an unspecified “mental disorder,” prompting concern over his fitness for the role he said includes making “major decisions that impact on public health,” The Daily Wire has learned.

#covid-19 vaccine #covid-19 #FDA #government #mental health #investigative journalism #new dark ages #modern medicine

[manstrans]

be careful if you're eating ice cream, at least in the US. all flavors of soft serve on the go have been recalled for listeria

might also just be a coincidence and unrelated, but I've been experiencing some symptoms after eating winco brand ice cream as well

[zoobus]

Go check your eye drops

The FDA recalled the products after its investigators found unsanitary conditions in the manufacturing facility and bacteria after testing environmental samples of critical drug production areas.

Check the FDA for the full recall list here

#fda recall #recalls #current events

[ralfmaximus]

Here's the complete list of DHS flagged search terms. Don't use any of these on social media to avoid having the 3-letter agencies express interest in your activities!

DHS & Other Agencies

Department of Homeland Security (DHS)

Federal Emergency Management Agency (FEMA)

Coast Guard (USCG)

Customs and Border Protection (CBP)

Border Patrol

Secret Service (USSS)

National Operations Center (NOC)

Homeland Defense

Immigration Customs Enforcement (ICE)

Agent

Task Force

Central Intelligence Agency (CIA)

Fusion Center

Drug Enforcement Agency (DEA)

Secure Border Initiative (SBI)

Federal Bureau of Investigation (FBI)

Alcohol Tobacco and Firearms (ATF)

U.S. Citizenship and Immigration Services (CIS)

Federal Air Marshal Service (FAMS)

Transportation Security Administration (TSA)

Air Marshal

Federal Aviation Administration (FAA)

National Guard

Red Cross

United Nations (UN)

Domestic Security

Assassination

Attack

Domestic security

Drill

Exercise

Cops

Law enforcement

Authorities

Disaster assistance

Disaster management

DNDO (Domestic Nuclear Detection Office)

National preparedness

Mitigation

Prevention

Response

Recovery

Dirty Bomb

Domestic nuclear detection

Emergency management

Emergency response

First responder

Homeland security

Maritime domain awareness (MDA)

National preparedness initiative

Militia

Shooting

Shots fired

Evacuation

Deaths

Hostage

Explosion (explosive)

Police

Disaster medical assistance team (DMAT)

Organized crime

Gangs

National security

State of emergency

Security

Breach

Threat

Standoff

SWAT

Screening

Lockdown

Bomb (squad or threat)

Crash

Looting

Riot

Emergency Landing

Pipe bomb

Incident

Facility

HAZMAT & Nuclear

Hazmat

Nuclear

Chemical Spill

Suspicious package/device

Toxic

National laboratory

Nuclear facility

Nuclear threat

Cloud

Plume

Radiation

Radioactive

Leak

Biological infection (or event)

Chemical

Chemical burn

Biological

Epidemic

Hazardous

Hazardous material incident

Industrial spill

Infection

Powder (white)

Gas

Spillover

Anthrax

Blister agent

Exposure

Burn

Nerve agent

Ricin

Sarin

North Korea

Health Concern + H1N1

Outbreak

Contamination

Exposure

Virus

Evacuation

Bacteria

Recall

Ebola

Food Poisoning

Foot and Mouth (FMD)

H5N1

Avian

Flu

Salmonella

Small Pox

Plague

Human to human

Human to ANIMAL

Influenza

Center for Disease Control (CDC)

Drug Administration (FDA)

Public Health

Toxic

Agro Terror

Tuberculosis (TB)

Agriculture

Listeria

Symptoms

Mutation

Resistant

Antiviral

Wave

Pandemic

Infection

Water/air borne

Sick

Swine

Pork

Strain

Quarantine

H1N1

Vaccine

Tamiflu

Norvo Virus

Epidemic

World Health Organization (WHO and components)

Viral Hemorrhagic Fever

E. Coli

Infrastructure Security

Infrastructure security

Airport

CIKR (Critical Infrastructure & Key Resources)

AMTRAK

Collapse

Computer infrastructure

Communications infrastructure

Telecommunications

Critical infrastructure

National infrastructure

Metro

WMATA

Airplane (and derivatives)

Chemical fire

Subway

BART

MARTA

Port Authority

NBIC (National Biosurveillance Integration Center)

Transportation security

Grid

Power

Smart

Body scanner

Electric

Failure or outage

Black out

Brown out

Port

Dock

Bridge

Canceled

Delays

Service disruption

Power lines

Southwest Border Violence

Drug cartel

Violence

Gang

Drug

Narcotics

Cocaine

Marijuana

Heroin

Border

Mexico

Cartel

Southwest

Juarez

Sinaloa

Tijuana

Torreon

Yuma

Tucson

Decapitated

U.S. Consulate

Consular

El Paso

Fort Hancock

San Diego

Ciudad Juarez

Nogales

Sonora

Colombia

Mara salvatrucha

MS13 or MS-13

Drug war

Mexican army

Methamphetamine

Cartel de Golfo

Gulf Cartel

La Familia

Reynose

Nuevo Leon

Narcos

Narco banners (Spanish equivalents)

Los Zetas

Shootout

Execution

Gunfight

Trafficking

Kidnap

Calderon

Reyosa

Bust

Tamaulipas

Meth Lab

Drug trade

Illegal immigrants

Smuggling (smugglers)

Matamoros

Michoacana

Guzman

Arellano-Felix

Beltran-Leyva

Barrio Azteca

Artistics Assassins

Mexicles

New Federation

Terrorism

Terrorism

Al Queda (all spellings)

Terror

Attack

Iraq

Afghanistan

Iran

Pakistan

Agro

Environmental terrorist

Eco terrorism

Conventional weapon

Target

Weapons grade

Dirty bomb

Enriched

Nuclear

Chemical weapon

Biological weapon

Ammonium nitrate

Improvised explosive device

IED (Improvised Explosive Device)

Abu Sayyaf

Hamas

FARC (Armed Revolutionary Forces Colombia)

IRA (Irish Republican Army)

ETA (Euskadi ta Askatasuna)

Basque Separatists

Hezbollah

Tamil Tiger

PLF (Palestine Liberation Front)

PLO (Palestine Libration Organization)

Car bomb

Jihad

Taliban

Weapons cache

Suicide bomber

Suicide attack

Suspicious substance

AQAP (Al Qaeda Arabian Peninsula)

AQIM (Al Qaeda in the Islamic Maghreb)

TTP (Tehrik-i-Taliban Pakistan)

Yemen

Pirates

Extremism

Somalia

Nigeria

Radicals

Al-Shabaab

Home grown

Plot

Nationalist

Recruitment

Fundamentalism

Islamist

Weather/Disaster/Emergency

Emergency

Hurricane

Tornado

Twister

Tsunami

Earthquake

Tremor

Flood

Storm

Crest

Temblor

Extreme weather

Forest fire

Brush fire

Ice

Stranded/Stuck

Help

Hail

Wildfire

Tsunami Warning Center

Magnitude

Avalanche

Typhoon

Shelter-in-place

Disaster

Snow

Blizzard

Sleet

Mud slide or Mudslide

Erosion

Power outage

Brown out

Warning

Watch

Lightening

Aid

Relief

Closure

Interstate

Burst

Emergency Broadcast System

Cyber Security

Cyber security

Botnet

DDOS (dedicated denial of service)

Denial of service

Malware

Virus

Trojan

Keylogger

Cyber Command

2600

Spammer

Phishing

Rootkit

Phreaking

Cain and abel

Brute forcing

Mysql injection

Cyber attack

Cyber terror

Hacker

China

Conficker

Worm

Scammers

Social media

SOCIAL MEDIA?!

#dhs #privacy #paranoia #security

[reportwire]

The FDA is investigating a Hepatitis A outbreak linked to organic strawberries sold at Walmart, Trader Joe's and other retailers

The FDA is investigating a Hepatitis A outbreak linked to organic strawberries sold at Walmart, Trader Joe’s and other retailers

The FDA is investigating FreshKampo and HEB brand organic strawberries for Hepatitis A Virus. Those brands of organic strawberries are sold at Aldi, Kroger, Walmart, Trader Joe’s, and more. The US has seen a total of 17 Hepatitis A cases connected to the strawberries, the FDA said. The Food and Drug Administration is investigating two brands of strawberries sold at top grocery stores for…

View On WordPress

#fda #hepatitis #investigating #Joes #linked #organic #outbreak #Retailers #sold #Strawberries #Trader #Walmart

[arodata]

Small PSA that you should probably be checking the ingredients in your personal lubricants, and looking up any chemicals you don't recognize, because I recently discovered that the astroglide brand water based lubricant I had been using contains quaternium-15, a preservative that slowly releases formaldehyde. From wikipedia:

"Quaternium-15 has been banned in the EU since 2017 and a bill was introduced in the US in 2017 to require the FDA to investigate its safety.[4][5]"

"Quaternium-15 is an allergen, and can cause dermatitis.[6] Many of those with an allergy to quaternium-15 are also allergic to formaldehyde."

"Although quaternium-15 releases low amounts of formaldehyde.[10] Even so, Johnson & Johnson announced plans to phase out its use of quaternium-15 in cosmetic products by 2015 in response to consumer pressure.[11][12]"

I'm sure you're more likely to have an adverse reaction to this if you have sensitivities to chemicals, but this cannot possibly be good for anyone to be putting in their bodies, especially long-term. I don't know which other brands use this, but astroglide is popular and cheap, so I felt the need to say something about that. This isn't common knowledge! I only checked what that chemical name meant because I was having recurring genital rashes and trying to rule out possible allergens

Sexual products *desperately* need to be better regulated than they are, but until then the best we can do is warn each other about this type of shit

#txt #leather

[reality-detective]

FDA finds new manufacturing lapses at Eli Lilly plant

Is this the beginning of the end or will it all be swept under the rug? You Decide 🤔

#pay attention #educate yourselves #educate yourself #knowledge is power #reeducate yourself #reeducate yourselves #think about it #think for yourselves #think for yourself #do your homework #do some research #do your own research #ask yourself questions #question everything #news #cnbc