PSC Hub

As PSC patients, many of us are told that there is no effective treatment for our condition. We are told that if we can find ways to manage our itching and fatigue, we can live a decent life until the day we will likely require a transplant.

 But there is hope that our lives can be so much better than that! 

Since 1993, Dr. Kenneth Cox and a handful of other doctors have been successfully using the antibiotic oral vancomycin off-label to effectively treat and manage PSC. I’ve been taking oral vancomycin since January 2018, and it has returned my elevated liver numbers to normal and stopped the progression of my disease.

I’ve even heard incredible stories from fellow PSC patients whose liver fibrosis was actually reversed thanks to oral vancomycin!

Vancomycin is hard for PSC patients to access for two main reasons:

1. It is Not FDA-Approved for PSC

Although small studies have proven oral vancomycin’s efficacy, the FDA has not approved the drug for PSC since there have not been any large randomized controlled trials (RTCs) that compare oral vancomycin to a placebo. (There have, however, been two small RTCs).

Since oral vancomycin is not yet FDA-approved for PSC, this creates insurance barriers.

Without RTCs, oral vancomycin must be prescribed by doctors who are willing to give it to their patients off-label. Unfortunately, many doctors aren’t familiar with the existing research, so they oftentimes don’t feel comfortable prescribing oral vancomycin off-label.

2. There are at Least 5 Nuances that Impact Vancomycin’s Efficacy

Dr. Kenneth Cox and his team at Stanford have identified at least five factors that impact oral vancomycin’s efficacy, including the drug’s brand and dose and the patient’s age, phenotype, and stage of disease. You can read more about these nuances here.

Since many gastroenterologists and hepatologists aren’t familiar with these small Stanford studies and oral vancomycin’s nuances, they may prescribe vancomycin without the knowledge of the drug’s efficacy factors or following the proper guidelines. Then, if the patient doesn’t respond, the doctor simply believes that oral vancomycin is ineffective and they become unwilling to prescribe it to any other patients.

 But when doctors account for these factors and prescribe oral vancomycin according to its best practices, it can sometimes stop, slow, or even reverse the progression of PSC. 

Despite the many lives that oral vancomycin has saved and the published papers and case studies proving oral vancomycin’s efficacy, it is incredibly difficult for us PSC patients to access oral vancomycin due to insurance barriers and doctors unwilling to prescribe it—even when our lives depend on it.

I believe this is unjust.

I think it’s wrong that, despite the existing research and countless success stories, it’s extremely difficult for us to access this potentially life-saving drug.

The Hope of Placebo-Based Randomized Control Trials

I am working hard with a group of other PSC advocates to create a randomized controlled trial on oral vancomycin for PSC. We hope that with the data this study will provide, the FDA will finally approve oral vancomycin for PSC and that it’ll become the standard therapy for PSC patients.

Until that day, this PSC Hub is a designated space for all things oral vancomycin for PSC, including supporting research, patient stories, tips to access the medication, vancomycin best practices, and much more.

I hope you find this PSC Hub both helpful and encouraging. If you ever have questions or would like more information, don’t hesitate to send me a message or email me at jenna@thecomicalcolon.com.

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