We call on Dr. Inderpal Randhawa and the leaders, advisors, and affiliates of the Tolerance Induction Program (TIP) of the Southern California Food Allergy Institute (SCFAI) and its research arm, the Translational Pulmonary and Immunology Research Center (TPIRC) to increase transparency and improve ethical standards in order to better serve their current and prospective patients.

1. Share data to back up TIP's claims to safety and high treatment success rates.

SCFAI markets TIP based on claims about the program's high levels of safety and extraordinary (99%) success rates, as compared to other treatment protocols (e.g. oral immunotherapy (OIT)).

TIP is one of the largest food allergy treatment programs in the United States, and diligently tracks fine-grained patient safety and outcome data. However, despite repeated requests from patients, SCFAI has refused to publicly disclose data to support its claims.

TIP's high cost and intensive, long-term time commitment means that patients urgently need better information to decide whether to enter treatment. The program typically costs more than $10,000 annually per patient, plus travel and hotel costs for out-of-state and out-of-country families. For many patients, these costs are borne out of pocket because TIP and its laboratories are considered out-of-network and/or its testing is considered experimental by many insurers, and therefore fees are not covered.

In order for patients to make informed risk-benefit and financial judgments about entering TIP treatment, we insist that SCFAI publish independently reviewed safety and outcome data on an annual basis. To ensure data integrity, we request that an independent advisory body be established to oversee data disclosure, with half the seats allocated to patients and patient representatives.

TIP's claims include:

• "Impact of TIP: 10,000+ patients | 99% success rate of TIP" link here (note that SCFAI does not disclose how "success" is defined)
• "In more than 50,000 in-office challenges with more than 3,400 patients, we have never had the need for epinephrine in our clinic. In over 50 million home doses, only 0.004% of patients have administered epinephrine." link here
• TIP "has achieved an unmatched safety record. 40% of patients complete the program without a single symptom (i.e. itchiness, hives, etc.). The remaining 60% of patients will have one to two episodes of Grade 1 symptoms (itching, flushing, small hives, angioedema) that will either resolve on their own or may require an antihistamine. Of the 60%, approximately half (30%) may have 2 episodes of Grade 1 symptoms that may also include eczema or mild gastro-intestinal symptoms." link here
• "There are many ways in which TIP differs from traditional OIT (Oral Immunotherapy)...The goal of TIP is for each patient to achieve true food freedom. Once in remission, TIP patients can tolerate large and infrequent doses of their allergens allowing them to maintain a normal diet without restriction or fear of reaction and can consume unlimited amounts of the foods to which they were once allergic." link here

As a starting point, the following data should be disclosed on an annual basis:

Safety data, including but not limited to:

• Rate of adverse effects during each stage of active treatment (with distinctions between treatment of "sensitized" and "anaphylactic" foods) and the maintenance/remission phase of treatment, with a clearly defined scale for grading the severity of reactions
• Frequency and types of medications used to treat adverse effects
• Hospitalization resulting from food dosing or food challenges
• Frequency of at-home administration of epinephrine following treatment and maintenance doses

Outcome data, including but not limited to:

• Treatment "success" rates, with clearly defined criteria for how TIP evaluates success
• Percentage of patients at different dosing frequencies in the remission/maintenance phase of treatment--dosing frequencies of daily, weekly, monthly, etc.
• Overall percentage of patients who have achieved true tolerance, also called “sustained desensitization,” and do not need to ingest their allergens regularly to maintain desensitization
• Percentage of patients who are long-term compliant during the remission phase of treatment
• Percentage of patients who drop out of the program annually, and cumulatively over time

2. Commit to transparency and adherence to ethical guidelines for scientific research on human beings.

TIP is a "long-term treatment, cohort research model," meaning it is a clinical study, which SCFAI says is overseen by two Institutional Review Boards (IRBs) and a Scientific Review Committee. However, SCFAI is not transparent about the names or locations of these advisory bodies, or who sits on them. Nor does SCFAI disclose TIP's research aims, or what protocols are in place to ensure that patients are adequately informed about the goals, methods, risks, and benefits of the research study.

Per established U.S. standards for the ethical treatment of people in scientific research, we insist that SCFAI disclose:

• the hypotheses that the TIP clinical study is testing;
• the methods used to test those hypotheses;
• how patients are selected for specific treatments (for instance how patients are sorted into TIP's endotype categories);
• how the program ensures patient safety and informed consent around the risks and benefits of treatment; and
• the IRBs it is using and the composition of its Scientific Review Committee, so that patients can engage with these bodies, and hold TIP accountable around patient ethics and informed consent in the future.

3. Disclose financial holdings, and potential conflicts of interest associated with, the for-profit businesses and entities affiliated with TIP.

Dr. Inderpal Randhawa is listed as a founder and/or owner in the following entities: Foundation Labs​, Serologix LLC​, GGG Immunotherapies, and Randhawa Ranch, a 40-acre agricultural "luxury ranch" in Temecula, CA that hosts retreats and events. It appears that many TIP patients are required to use the products and services of Foundation Labs, Serologix, and GGG Immunotherapies as part of TIP treatment. Randhawa Ranch hosts some SCFAI events, and SCFAI recently posted a job for a Ranch Hand to care for the property.

Full transparency about the financial holdings of Dr. Randhawa and his associates is essential to ensure that patients' rights are protected, and they are not being exploited for the financial gain of the owner(s) of these entities.

4. Disclose the facts about how the TIP "philanthropy" program gives wealthy patients preferential access to treatment, and undertake an ethical review of this practice.

It has been reported that SCFAI operates a "philanthropy" program for TIP, whereby patients who "donate" $100,000 to the program can skip the treatment waitlist and enter immediately into a privileged treatment "track," with preferential access to appointment times.

This program is not, in fact, philanthropy, but instead a system of preferential access to healthcare that privileges wealthy individuals. It reinforces income and health inequalities by enabling individuals with substantial financial resources to step in line ahead of people who are less well off financially.

This preferential access program should be publicly disclosed on the SCFAI website. We also call for a review of this practice by a medical ethicist affiliated with the Medical Board of California to evaluate whether it violates state norms or regulations.

5. Appoint a neutral facilitator and independent oversight group for TIP's official online patient information group, the Southern California Food Allergy Institute's Kitchen Table on Facebook. This body should establish and enforce the rules and standards for civil, respectful discourse, and transparency about TIP in the online TIP patient community.

SCFAI hosts and moderates a 4000+ member Facebook group for current and prospective TIP patients. With little peer-reviewed or independently verified data available about TIP, this group is one of the few places where patients can turn to ask questions about the program's methods and outcomes.

However, the culture of this group stifles transparency and fosters a cultlike atmosphere around the program. The group moderators permit some members who are fiercely loyal to TIP and to Dr. Randhawa to attack and harass newcomers for asking questions that are perceived as challenging or skeptical about the program’s claims, methods and outcomes. Vocal TIP adherents say that such questions are unwelcome, and they insist that the purpose of the Facebook group is solely to support people who are "committed" to the program. They advise newcomers to set any doubts aside, and simply trust in the process and the doctor. Some discussion threads on the Facebook group have blown up into hundreds of comments, with loyal patients defending TIP and aggressively condemning those who are asking questions about the program.

As the host and moderator of this Facebook group, SCFAI is responsible for defining the purpose of the group, and enforcing rules and standards for civil, respectful discourse. However, the forum moderator(s) are doing the opposite. The primary forum moderator (a SCFAI employee) contributes to the negative culture of the group with defensive responses and repeated claims that TIP and Dr. Randhawa are better than, smarter than, and superior to other allergy doctors and treatment approaches. He occasionally directs contemptuous and personal attacks on members who persist with questions. Members who ask questions about TIP methodologies or question the moderator’s response are routinely banned from the group, and their comments are erased. This results in an echo chamber, which creates a barrier to a truthful and open exchange of information about TIP for prospective patients. 

This negative culture presents a risk to patients and to TIP's reputation, and must be changed so that both prospective and current patients feel safe to ask questions and report negative experiences without fear of being attacked by other group members or removed from the group.

In summary, addressing these five points would greatly improve TIP's ability to serve its current and prospective patients, and better support patients' rights to information that helps them choose safe, efficacious, cost-effective, and ethical allergy treatment for themselves and their families.

*This petition was created by a group of former and prospective TIP patients.