Foreign Clinical Trials: Cause for Concern?

What are the Concerns for Foreign Clinical Trials?

Are there ethical or data integrity concerns for foreign clinical trials used for FDA drug approvals? Are the research standards as high as in the United States? What are the challenges facing developing countries in conducting clinical trials? Two recent reports discuss the issue. One report is by the Inspector General of the U.S. Department of Health and Human Services on “Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials.” It was reported on in an article by Gardiner Harris of the New York Times. The report noted that FDA isn’t able to conduct foreign inspections at the same level as at domestic clinical trial sites and that trials were dramatically increasing in places such as Latin America that lack strong regulatory oversight. The report recommends “FDA should continue to explore ways to expand its oversight of foreign clinical trials.”

Read the Report on CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT FOREIGN CLINICAL TRIALS and Read the New York Times Article.

MRCT Project

The second report I learned about when I attended a session at the recent meeting of the Drug Information Association (DIA). The session discussed the challenges of international clinical research, particularly in developing countries. In a report of the Multi-Region Clinical Trials (MRCT) project, problems were discussed and practical recommendations suggested for improving the quality of clinical trials in resource-deprived countries.

I was impressed with the panelists who presented to DIA on the MRCT project. The focus was on how clinical trials could be conducted in developing countries with resource challenges. How could the rights, safety, and welfare of research participants be protected? The session was chaired by Mildred Solomon, EdD, Associate Clinical Professor of Medical Ethics at the Harvard Medical School. She discussed the formation of the MRCT project and the report that resulted. Other panelists included Allan Johansen, DVM, Susan D’Amico, and Janet Wittes, PhD. According to the report the MRCT project was:

“Initiated by Pfizer, the Multi-Regional Clinical Trial (“MRCT”) Project began with a Summit Meeting in July 2009 to identify ways to enhance the planning and conduct of multi-regional trials and the integrity of these trials. The Project has involved experts from large and small companies, clinical research organizations (CROs), non-industry sponsors of research (such as participants from the National Institutes of Health), non-industry researchers and bioethicists, and others. The discussions have focused on opportunities to enhance research ethics, ensure respect for study subjects, strengthen fairness and equity in clinical trials, protect subject safety, and identify other opportunities to improve MRCTs involving the developing world.”

The project formed work groups to cover five areas:

1. Efficiency and quality of ethical review
2. Data & safety monitoring
3. Site selection and investigator
professionalism
4. Monitor performance
5. Transparent contract amendments

Five Workgroups Formed the MRCT Project

The report discusses the problems in each area and offers some solutions. For example, work group one proposed to “Include an ethics section accompanying each/certain protocols (to help ethics committee review the proposal, as needed).” Work group 4, which focused on monitor performance, proposed to: “Establish a comprehensive set of recognized and expanded core competencies for monitors.”

The report concluded by noting:

“This Report has focused on outcomes that sponsors and CROs have the ability to impact and, thereby, improve research ethics and data integrity in their own operations or through collaboration. Since there is already broad acceptance of foundational ethical principles, the next important step is to ensure operational alignment with those principles.

Predominantly, the MRCT Work Group proposals focus on achieving that alignment through greater professional competence of the many players who must contribute to the global research enterprise. Professionalism is essential to the ethical conduct of clinical research. Just as scientifically unsound research is unethical, so too is research conducted in a manner that cannot ensure the integrity of the science, the quality of the data, and respect for and safety of research participants. Assuring all individuals engaged in research are properly qualified through education and experience is a theme throughout this Report.”

The report also noted that developed countries and the pharmaceutical industry need to assist with resources to achieve this goal. This is certainly an important point. However, the devil is always with the details. Finding a way to finance improvements may prove difficult.

Read the MRCT Report

My own viewpoint is that we should stop referring to “foreign” clinical trials. Clinical research is globalized and we need a strong international component. Not all of the answers are in the United States and we would do well to listen to those from outside our borders, particularly those from the developing world. To me, referring to clinical trials from outside the U.S. as “foreign” infers that they are inferior to trials conducted in the U.S. I don’t think that is always the case. Why don’t we call them “international” or even “multi-regional” trials instead? If we view international research as something that is a shared responsibility then perhaps there would be less concern over “foreign” clinical trials.

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GxP Training Part 2: Regulatory Compliance for FDA Regulated Industry

What is the Best Method of SOP Training for GxPs?

GLP; GCP; GMP; GxP, just how may good practices do you need to know in the world of regulatory compliance for FDA regulated industry? In part 2 of this Guest Commentary by training specialist Nancie Celini she discusses the pitfalls of “Read and Understood” as a concept for GxP training on standard operating procedures. This was discussed last week at a training workshop at the Drug Infomation Association’s (DIA) Annual Meeting. While I prepare some comments on my favorite sessions I am giving you part 2 of Nancie’s excellent commentary.

Guest Commentary
Part 2:
Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program
June 9, 2010
Nancie E. Celini, GxP Learning Program Lead

In the previous article I discussed the use of the acronym “GxP” as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

Sponsor organizations have traditionally relied upon a “Read and Understood” approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details may leave an organization vulnerable. Employees need to fully understand their job role and responsibilities in context as regards the regulations that keep the organization compliant.

FDA Requirements for Training and Experience

FDA has (and will) cite companies for deficiencies in their training programs. U.S. regulations can be broad and subject to loose and often incorrect interpretation. The regulations stipulate that personnel must have “training and education and/or experience” to enable them to fulfill their role. In today’s dynamic e-clinical environment where many functions are virtual and rely upon third parties, this phrase takes on new meaning.

GxP learning programs must be robust and comprehensive and should include the following components:
• Introductory Level (GCPs, GMPs and/or GLPs) for new employees

• Policy and provision for outsourced / consulting personnel who perform regulated activities for you

• Yearly refresher GxP courses that don’t just recite regulations but focus on changes to existing regulations as well as emerging guidance and trends of health authorities / regulators (as well as the political context / global issues / economics and externalities)

• A blend of leader-led and on-line courses (e.g. a “hybrid” model)

• Qualified learning professionals / instructors who lead, manage, deliver and sustain the program

• Complete training records; current organization charts; descriptions of roles and responsible parties in the chain of authority; current job descriptions and records of training courses completed linked to roles / responsibilities

• Curriculum Vitae (updated as changes occur)

• Organizational Training Policy and SOP that govern the overall GxP program

A GxP learning program should be role-specific regarding organizational job descriptions and collaboration across functions (clinical, regulatory, human resources, training, etc.). This is critical and likely to be where gaps in procedures and training can occur. Personnel need to understand how procedures relate to each other. Often there is no reference from one process to another that creates these gaps that can lead to deficiencies and ultimately, citations.

Are There Advantages to a Learning Management System?

Many organizations have invested in a GxP learning program that includes some of these elements but leadership and strategic planning combined with a learning management platform (a.k.a. LMS) can help to streamline content delivery as well as training records management. Efficient programs can be ramped-up very rapidly and when the paper is removed and an LMS is integrated with an electronic document management repository that manages the lifecycle of procedural documents. An LMS can help an organization save time, money and create an exciting and engaging program when combined with a rich assortment of industry courses. Content that is updated annually and delivered through a low-cost hosted, 21 CFR Part 11 validated system is a goal worth striving for. An LMS is no longer a solution for a large organization. The LMS market has stabilized more than in previous years and there are economical solutions for small organizations as well as robust systems that can support large global organizations.

But don’t forget the classroom. Leader-led sessions enhance the read and understood approach especially for procedures and allow professionals to work collaboratively. And the right LMS can manage your leader-led program as well as your on-line content.

As an educator I want to close by giving you some retrospective history about “training” in our industry. At one time training departments were plentiful in this industry with knowledgeable trainers who were committed to their trade. Due to previous economic downturns, the industry started to downsize and cut many training programs. Sadly, it has been hard to come back from these difficult times and we find ourselves in the midst of climbing out of yet another tough economic trough. Considering patent expirations and tough business and scientific challenges we all face, it is often difficult to justify a program that I have described. But the business of training needs to change in our industry as I’ve seen too many deficient programs that have been relegated to an unimportant level in many organizations. Here is something to reflect on from John Dewey;

“Any genuine teaching will result, if successful, in someone’s knowing how to bring about a better condition of things than existed earlier.”

GxP Training for Regulatory Compliance

Isn’t it time for our industry to learn collectively how to bring about a better condition? As an industry we all need to remember that our work is focused on how to ease human suffering and the search for new remedies to cure disease and improve human health. How will we all learn to do better without the right tools and insights? This is the challenge we all face as we rebuild and renew our organizations during this time of unprecedented change.

If you are interested in this topic or further discussion about transforming from training to learning in this changing industry, please feel free to reach me through Carl’s blog. I want to say a great big thank you to Carl for providing this space for thoughtful discussion and insight. I hope you have enjoyed these thoughts on GxP education.

Good luck and good learning!

Read Part One of Nancie’s training article

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

GxP Perspectives LinkedIn Group

FDA Commissioner Stresses Regulatory Science at DIA

Dr. Margaret Hamburg, Commissioner, U.S. Food & Drug Administration

Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, addressed the 46th Annual Meeting of the Drug Information Association (DIA) stressing the importance of regulatory science for the future of FDA and the biopharmaceutical industry. The DIA meeting, held in Washington, DC, is on the theme of “Facilitating Innovation for Better Outcomes.” Eight thousand participants are attending the meeting from 80 countries with representatives from 20 different regulatory agencies. Dr. Hamburg’s remarks stressed two specific points: regulatory science and the globalization of the commodities that are used in our food, drugs, medical devices and other FDA regulated products.

Dr. Hamburg spoke to a packed auditorium that had first been serenaded by the Adagio from Dvorak’s New World Symphony played by the Bel Canto Strings. She recounted that FDA had been formed as a result of the efforts of President Teddy Roosevelt who was president when the Pure Food and Drug Act was passed in 1906 and FDR who signed the Food, Drug, and Cosmetic Act into law in 1938. She gave ultimate credit to Abraham Lincoln who authorized the Bureau of Chemistry in the Department of Agriculture that eventually became FDA, noting that Lincoln was on the cover of the DIA program.

Dr. Hamburg's First Year at FDA

She noted that she had now been FDA Commissioner for one year and that “the learning curve has been steep.” She said that it was a particularly challenging time with the different and complex requirements that come with the recognition that we live in a globalized world. Dr. Hamburg joked about her Aunt Minnie who asked why she didn’t become a “real doctor” when she took over the New York City Public Health Department. She said that her public health training has helped prepare her for the job of FDA Commissioner and to be a “real doctor to 300 million people.”

Dr. Hamburg stressed that a gap had been formed between bioscience and regulatory science, that the tremendous advances in research could not translate into products for the public health without the resources and skills for the regulatory scientists at FDA. She gave four specific examples where promising research required advances in regulatory science to bring products to market. She spoke about stem cell research for Parkinson’s disease that needed valid processes for development of the stem cells. She listed an Artificial Pancreas for diabetes that would allow a testing path that wouldn’t lead to severe hypoglycemic events. She also cited research from the National Institutes for Health that had lead to progress in tumor markers and in advances in drug-resistant tuberculosis.

The Percentage of Imported Food and Drugs Continues to Rise

Dr. Hamburg emphasized that regulatory science was “much bigger than FDA” and encouraged participation by industry and academia. She then turned to the challenges from a globalized market place noting that there are 20 million shipments of FDA regulated products imported into the United States each year. This includes 40% of produce, 70% of seafood, and 80% of active pharmaceuticals ingredients (APIs) and drug products. She said that FDA would increase the number of international inspections and personnel stationed overseas. However, she said that FDA alone couldn’t guarantee safe food and drugs and that there was a need to harmonize standards and approaches saying that the “new paradigm goes far beyond our borders.”

A Missed Opportunity?

Hamburg’s speech did not have any specifics regarding current issues in drug regulation including the recall situation at McNeil for children’s tylenol. It is unfortunate that she did not take the opportunity to directly address the biopharmaceutical industry with FDA’s current viewpoints or concerns regarding drug safety. It was a speech that did not mention the terms “good manufacturing practice” or “clinical trials.” In fact, it was remarkably similar to her speech to RAPS last summer in Philadelphia. That’s too bad. A very good speech but an opportunity missed.

However, DIA had a number of good sessions the first day. They included an excellent session on “Virtual Realities: Quality Considerations When Using Outsourcing Providers” chaired by Bruce Wagman and the equally excellent session on training chaired by Steven Steinbrueck. I’ll discuss these and the other sessions I found the most interesting in a few days.

GxP Perspectives LinkedIn Group

GxP Defined: Training for FDA Regulated Industry

GxP Training- An Absolute Requirement

Just what is “GxP?” Do people in FDA regulated industry need training? And just why do you call the Blog, “GxP Perspectives?” These are good questions and we have a Guest Commentary from Nancie Celini, a GxP training specialist, to help answer the first two. She has written a 2-part introduction to GxP training for the Blog. I will put up the next part in a week after, hopefully, doing some on the scene blogging at the DIA Annual Meeting in Washington DC. As far as question #3 about why I call the Blog “GxP Perspectives?” I’m not sure, I just didn’t want to just be writing about “stuff.” So now, Here’s Nancie.

GUEST COMMENTARY

Part 1 of 2 Parts:

Defining GxP Training / Learning

By Nancie Celini
June 8, 2010

The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem “elementary” to some of you, many people may not know what this means. So let’s define it because when we refer to “GxP training” you need to have the right context.

G = Good
x (variable replaced with Clinical, Manufacturing or Laboratory)
P = Practice

As you can see, GxP is used as short-hand form for referring to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. Sometimes people refer to the “GCPs” which specifically regards the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). Together, these are known collectively as the “predicate rules” that govern a wide spectrum of regulatory obligations across this diverse industry. This is also where citations emanate from (typically) as regards FDA inspections. Violation of a predicate rule will most likely result in a 483 followed by a warning letter. Get it? There is just a bit more to help you navigate this important terrain before we delve into why a GxP training / learning program is vital.

When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 means:
21 = Title 21
CFR = Code of Federal Regulations
312.2 (312 = part and 2 =section)

There is a helpful website to quickly find and research the regulations. As an educator in our industry and academia I strongly suggest you read the ones that pertain to your role and specific area even if you have read them before. It is important to stay current! Using this site you can search by the actual regulation or key words. Go to:

http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm

Regulations Assign Responsibility

Remember that federal regulations are laws and they establish the obligations that sponsor organizations, investigators and IRBs/IECs (institutional review boards and independent ethics committees) must be compliant with. This includes the requirement to engage personnel who are effectively trained by way of education and / or prior experience and on-going training. An example from the CFR;

21 CFR 312.53 Selecting investigators and monitors.
 (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
Ibid.
 Viii. (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.

SOP Training in GxPs

If you are responsible for a “GxP” task, it is an easy way to say you are performing a regulated process that is most likely linked to a predicate rule or guidance and should be covered by policy and / or specific documented procedures (a.k.a. SOPs) that you are trained in. Some examples include development of a protocol or monitoring a clinical study. These are the types of topics that should be covered when designing a “GxP learning program” as well as procedures and yearly refresher programs. The more diverse your organization, the broader your program(s) should be for enabling personnel to learn what they need to in deference to the professional backgrounds they brought with them when they were hired. Programs today must be more robust than ever to accommodate all the topics we are all challenged to be knowledgeable in. A brief yearly refresher alone is often not enough.

In the next article I will discuss why a comprehensive learning strategy and program must be in place if today’s bio/pharmaceutical organizations are compliant with the regulations and poised for change and transformation. Peter Senge said it best when he described learning organizations as:

“…organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together.”

Seeing the “whole” as regards GxP is imperative and will keep your organization on track with existing rules as well as emerging ones. After all, we find ourselves in industry during interesting times of global trials with virtual reach as well as economic and healthcare reform. Do you know what the implications of the current reform legislation are regarding the bio/pharmaceutical industry? That is something for homework. We all need to be ready to transform and respond nimbly to the changes that are coming.

There is more to come in the next article but if you haven’t read Senge’s book I highly recommend you do especially if GxP training is your responsibility. Senge’s work is timeless as we prepare for the challenges and excitement of a new road ahead.

Good luck and good learning!

Read Part Two of Nancie’s training article

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

GxP Perspectives LinkedIn Group

FDA 1572: Big Changes in FAQ Information Sheet Guidance

Most Study Coordinators Belong on the FDA 1572

FDA has made some big changes in the final version of their Frequently Asked Questions (FAQ), Statement of the Investigator (Form FDA 1572) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010). The FAQ states that research coordinators (study coordinators) should “usually be listed in Section #6 of the 1572.” This is a significant change from the draft FAQ Information Sheet Guidance that came out in July 2008. Many clinical sites do not list study coordinators on the FDA 1572. It means that most study coordinators will need to file financial disclosure information. It will be a significant change in the way FDA inspects clinical sites. Specifically the FAQ document states:

“Generally, a research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the study data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the 1572.”

You can review this in Section 33, page 14 of the Final FAQ on FDA 1572s. This is a big change from the July 2008 draft FAQ:

“If a research coordinator is performing critical study functions and collecting and evaluating study data, the coordinator should be listed on Block #6.”

This is a very significant difference and not just because they changed “Block #6” to “Section #6.” FDA is saying that a study coordinator “generally” performs critical study functions. And FDA says that recruiting subjects is one of those functions. Obtaining informed consent, although not stated in the FAQ, is also regarding as a critical function. FDA made that clear in a Warning Letter issued October 1, 2008. The Warning Letter states:

FDA Makes a Clear Statement on 1572 Requirements

“Study coordinators who administered the informed consent, determined subject eligibility and dispensed study drug were not listed on the Form FDA 1572, Statement of Investigator, for protocols (b)(4) and (b)(4). By performing these significant study activities, the study coordinators should have been listed on the Form FDA 1572s as subinvestigators.”

Although the 1572 FAQ, like all FDA Guidance Documents, states that it “Contains Nonbinding Recommendations,” the Warning Letter makes it crystal clear that “nonbinding” only goes so far. My advice?

Put your study coordinators on the 1572 pronto.

UPDATE: Remember that the FAQ does not need a CV for subinvestigators, just financial disclosure. It’s in the FAQ

UPDATE 6 January 2011: Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

Another update: Read an updated version of this article in
Applied Clinical Trials

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The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

Comment:

For some reason WordPress isn’t showing comments for this post:

Carl,

Just discovered your blog and find it rather helpful. Our site is looking at the new 1572 guidance and will be implementing changes soon. I am not happy with the guidance for Sub-Investigators (VII, Section #6, #31) because it still leaves the interpretation wide open as to who provides “direct and significant contribution to the data.” We do oncology research and the nature of the care and treatment of these patients means that dozens of staff are involved. An auditor could intrepret that each of those staff members has a significant contribution to the “data.” I am not comfortable that Section #6, #32 protects us.

I know the Delegation of Authority log was never an official FDA document but it seemed a much more efficient means of informing Sponsors of who was conducting procedures for their studies. For me the 1572 should be reserved for those who make the decisions that a clinical trial is appropriate for given research subjects and for whom financial (or other) incentive could bias the enrollment and outcome of a trial . In our situation, that would be the physians who order the treatment for their patients. Staff assist in that process, but a study coordinator is never the one who decides that a treatment is appropriate. What brought about the need to expand the definition of who is a “sub-investigator?”

Thanks for your comment:

I basically agree with you about the study delegation log. It was in the guidance “Investigator Responsibilities” (October 2009) and I thought that it was a good vehicle for this type of situation. I do not have a clue why this has been emphasized at this time. Please make sure you look at section 32 of the FAQ where it addresses residents:

“Concerning staff residents on rotation, it may be difficult to prospectively identify those individuals who might perform specified protocol procedures or collect clinical data. Specific names of the rotational staff do not have to be listed in Section #6. Instead, to successfully address this scenario, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical study records.”

This paragraph is at the top of page 14 in the FAQ.

Carl-

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H1N1 Warning Letter for “Dr. Coldwell”

Snake Oil for Swine Flu

This one is a doozy as FDA continues to take on phony H1N1 cures. It hearkens back to the days of snake oil remedies that helped lead to passage of the Pure Food & Drug Act of 1906, along with the crusading novel, “The Jungle” by Upton Sinclair. The remedy is called, I kid you not, “Dr. Coldwell’s Anti-Viral/Flu Protocol,” and is taken over a 30-day period to ward off “Swine Flu.” Hopefully, with summer upon most of us (I live in the Pacific Northwest where summer is evidently illegal), we won’t be seeing many more.

UPDATE- Health fraud on a different topic from the FDA Alumni Association: FDA is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

Read the Warning Letter for “Dr. Coldwell’s Protocol.“