How Contaminated Stool Stored in a Freezer Left a Fecal Transplant Patient Dead

You would think it would be common sense in the field of Medical research and science to go back and test the older frozen stool that had been stored, to simply double check it does not cross contaminate with the new stool. Which was not done which resulted in patients’ health jeopardized. If I was one those patients who had cancer and knowingly was taken medication that resulted in a suppression of the immune system I would sue whoever was involved in that lab where the stool was stored. This is not a minor error this could take a life just like that.

This is a potential issue that could even be existential and we need to address it head on and always be ahead of the game,” said Dr. Khoruts. Always suspicious when someone uses the word "existential"

I hope the families of the victims here sue the pants off of Mass General. This goes beyond .... " This has been professionally challenging " .....

This is not a good mistake and if you are the family that is affected, it's horrible. But, how about the thousands who have been saved by this treatment? Mass General is taking ownership of the mistake and steps to prevent it from occurring again. This is how we learn.

As bad as this was, I am heartened that the doctors owned up to their mistakes and highlighted their errors, so that at least they (and others) might learn from them. Progress never happens unless mistakes are frankly acknowledged and learned from. A lesser doctor might have tried to sweep this under the rug or try to paint the mistakes as unavoidable, but they choose not to. That is commendable. It will save lives. I wish all doctors (and those in other professions) did the same.

Everyone wants health care yet the words should be quality health care, the new angle is admitting that we made a mistake and all should be forgiven, so lets write a paper about it and all will be forgiven. People are dead and mistakes were made, Kurds are dead and its no big deal. Since nothing will be done to ensure this mistake doesnt happen again so lets all move on which is the American way, nothing in regards to health care matters at all to the medical community.

Did the donor freeze to death? "... the lead author of the article and an infectious disease specialist ... expressed remorse over her lab’s failure to test stool from a donor that had been stored in a freezer for several months."

Was there any reason why authors did not place a hyperlink to the original journal article?

Anyone who has dealt with the current medical community in the United States, should realize that YOU ARE ON YOUR OWN! Buyer Beware! I know people who aren’t even Catholic, who say a Hail Mary, before they step foot in a Doctor’s office, Clinic, or Hospital!!!

Cutting edge medicine will always carry a risk simply because the scientists and practitioners are human beings. We need to keep this in perspective: "OpenBiome, a nonprofit stool bank in Cambridge, Mass., that has provided 50,000 doses in recent years without any reported serious adverse events..." Kudos to the doctors at Mass General for being so candid about their errors.

It is laudable to publish a negative outcome. And yes, we are talking about a lost human live. But, as it always happens, there is something to learn from a negative experience. Scientist working on this subject will have to rigorously test the storage conditions of fecal samples, how long, what temperature, etc.

The FDA is generally not in the habit of making random recommendations, so when it added E. coli to the list of things to be screened for, there must have been a good reason. That reason, it seems to me, must have been its prevalence had become a real problem. The reason given for not testing frozen samples (some mash up of (a) the FDA didn’t specifically order it and (b) it never occurred to us to do it on our own) flies in the face of common sense - as commenter Rosalie Lieberman, RN pointed out, but would seem at odds with one of the basic tenets of the Hippocrates oath of do no harm. I think that, sadly, the excuse advanced was made to distract from the more obvious explanation: money. All experimental treatments of this kind are very expensive and donor funds are limited. Choices are made all the time, though few have life threatening consequences. This one did. While the article provides no evidence one way or the other, why do I nevertheless have this gnawing feeling that when presented with the estimate (whether by formal inquiry or a back-of-the-envelope guesstimate) for re-testing all the frozen samples, the price tag drove the decision, a decision made a bit easier knowing that they could could point to the FDA’s failure to specifically demand such re-testing to deflect any blame should their gamble fail? I just hope I am wrong.

It's good they've changed the protocols to ensure they've tested for antibiotic resistance. We should be mindful of what feels weird and terrible vs. what's normal and acceptable. Roughly 80 people died yesterday from C. difficile. If we're horrified or angered by one person dying of a mistake, but not horrified by all the people who die unable to access this treatment, that's perhaps not consistent.

The scientists made mistakes which they acknowledged. It should be also pointed out that the treatments were experimental. Patients are routinely warned that experimental procedures have risks. Here, the researchers did what they were supposed to. They tried a treatment, evaluated the results, and then tried to figure out what went wrong. They then published their experience as a cautionary story for others engaging in similar lines of research.

Good on the researchers for putting this out there. I am a critical care doctor and treat patients like the two mentioned in this article - patients who have a very narrow and challenging path to survival where everything must line up perfectly to achieve a good outcome. To get e.coli, or any intestinal bacteria in the blood (we all have E. coli living in our intestine, usually in a harmonious manner) into the blood stream there has to be a breakdown of the intestinal wall as well as a failure of the immune system. Immunocompromised patients with infectious colitis are a set up for this - so with or without the fecal transplant, both these patients would have developed a bloodstream infection with enteric organisms independent of the fecal transplant - the fecal transplant's role was only in inducing antibiotic resistant strains of normal intestinal flora. People die from gram-negative sepsis at high rates even on the correct antibiotics. It is a bad thing to have. It makes sense to screen stool for ESBL organisms and other resistant organisms like vancomycin-resistant enterococcus - but it's a leap to assume that these patients would have had a good outcome had they received an ESBL-screened fecal transplant. Both would have still had life-threatening bloodstream infections with a 30-40% mortality rate at the end of the day.

"was that the F.D.A. did not instruct doctors to test or destroy older..." Really? This is the same agency that had no problem with the flood of opioids hitting the market, and therefore, patients. If I were in this business I'd follow what the FDA recommends as log as it makes sense to me. Leaving old stuff lying around that might be used doesn't make sense.

Many commenters are lambasting the researchers. This was clearly not malicious and nor was it incompetence. Science is done by humans. You want perfection, go into Theology.

They didn't think of testing the older stool? Would anyone give blood transfusions if the rules suddenly changed, and you still had frozen blood stores that logically needed to be retested, too? Hate to say this, based on stupid errors I saw when I worked as an RN, but many mistakes in hospitals are from a lack of common sense, simple logic that isn't used, or totally missing. You can teach volumes of information to bright people, but you cannot teach them common sense if they are missing it.

[The problem, Dr. Hohmann said, was that the F.D.A. did not instruct doctors to test or destroy older material kept in storage. “It wasn’t obvious to a lot of smart people here,” she said. “We didn’t think to go back in time.”] The article is not completely clear and in fact possibly misleading, but I am guessing that the FDA recomened rules for testing were changed, and while those new tests were applied to new donor material, they weren't applied to older donor material in the freezer. In that case couldn't the tests have been applied to the older material in the freezer? (And only throw out the material that tested positive?) The way it's phrased could lead some people to believe that it had spoiled from age. Furthermore, with regards to patients who had received that material but did not get sick, wouldn't they still have the resistant ecoli in their gut, meaning that if they did get sick for some toher reason, and were given the wrong antibiotics, those ecoli could bloom, and they would suffer?

The problem, Dr. Hohmann said, was that the F.D.A. did not instruct doctors to test or destroy older material kept in storage. “It wasn’t obvious to a lot of smart people here,” she said. “We didn’t think to go back in time.” The doctors needed to be told to destroy the old samples kept in a hospital freezer? I would not need to be told to throw away the remaining frozen pizzas in my fridge after feeding pizza to my family, with the result that we all got sick and one of us died. I guess the hospital's PR unit didn't have a chance to get to Dr. Hohmann before she made this public statement. Yes, the medical establishment is fallible. But this was gross negligence, i.e., stupidity.

I am so glad that these doctors published their error, so that we can all learn from it, and perhaps prevent this and eve other errors in the future. And even old established safe procedures can be dangerous: My daughter became gravely ill as an infant, and required 2 blood transfusions. Three years later, we received a letter, informing us that blood supplies then were screened for hepatitis A and B, but not C, until a test for hep C had become recently available. We were invited to test her for hep C, which at that time, had no effective treatment. Her test results were negative (which was the most likely outcome), and a huge relief. But it’s a sobering reminder that medical practice, while very, very good, is not risk-free. And I am glad that we were notified of this potential problem.

Why can't they institute a process where the bacteria being introduced is first tested to make sure there is at least one anti-biotic that can kill the bacteria ?

It should have been common sense to test for any drug resistant strain of E.coli. In performing with experimental treatments you the patient usually sign your life away giving consent in case anything goes wrong you can't sue. That is unless there is gross negligence on their part. This I guess was an oversight not sure if it rises to the level of gross negligence.

The doctors' honesty is appreciated. But, this was not only a fatal mistake, it was an epic failure of common sense. Promising new treatments do fail. Patients do die. But the old "we were just following orders" or we weren't told to test or destroy old samples" routine - really? These are infectious disease specialists - what were they thinking? Or clearly, they were not.

Not to be insensitive to the people who lost their lives, but since when do we expect medicine/doctors to be perfect? Sadly, mistakes are learning opportunities, or should be. It is tragic that people died in this circumstance, but thousands of lives will be saved because of information gained. Progress is not always linear, unfortunately, But, not everything could be learned in a lab. My condolences to the family of the gentleman who lost his life.

This is why there are medical malpractice lawsuits. Doctors make horrific mistakes that cost their patients their lives.

The last paragraph, as it appears, could be a textbook example of how to leave readers hanging. No explanation of what in the world Dr. Khoruts has in mind as to how, potentially, to get ahead in this "game" by addressing the "potential issue . . . head oern". Otherwise an excellent and interesting article.

It’s not just immuno-suppressed patients receiving fecal microbiota transplants who are at risk. I had a prostate biopsy that had the same problem. The urologist did not perform a stool culture prior to the biopsy and, because I have had an adverse reaction to fluoroquinolone antibiotics, which were the preferred prophylactic, unknowingly used an antibiotic to which my fecal e coli was resistant. Two days later I developed a high fever, uncontrollable tremors, extreme chills, near maximum pulse and called 911. Once admitted, a diagnosis of sepsis was confirmed, I was placed on broad spectrum antibiotics and cultures were started. Ultimately they confirmed infection with a strain of e coli that was resistant to the antibiotic used, I was treated with a targeted antibiotic, and I was discharged without complications. While I was in the hospital I asked the staff microbiologist why my urologist didn’t perform a fecal culture in advance of the procedure. He smiled nervously and muttered that some urologists do perform cultures before prostate biopsies.

From the article-' The problem, Dr. Hohmann said, was that the F.D.A. did not instruct doctors to test or destroy older material kept in storage. “It wasn’t obvious to a lot of smart people here,” she said. “We didn’t think to go back in time.” ' Napolean said "Any fool can learn from their own mistakes." So much of medicine points to this. By definition, they were not "smart" people doing this- certainly not wise. There is a huge chasm between gifted thoughtful visionaries vs. trial by error humans. During the 20th century, physicians were considered god-like, now more like auto mechanics. The truth lies between, but within the range are impatient doctors not considering the relevant risks. It seems obvious to check for pathogens, esp when dealing in immuno-suppressed or compromised people. Watch one, do one, teach one does not work in new and boundary pushing ideas. Be a thinker and not simply a doer.

Great discoveries save lives. However, working out the safety and efficacy can falter, as this situation illustrates. The rush factor can cut out possibilities on the extensive “what if” scenario list, some of which can increase risk significantly. My so had a lung transplant procedure where during the surgery, bacteria from his diseased lungs leaked out into his chest cavity before the new lungs were attached. That introduced bacteria that colonized quickly due to the effects of anti-rejection drugs - ultimately, taking my son’s life in six short weeks. The new lungs were ok, never affected. He could breathe well to the end. They changed the procedure after this. Academic procedural change. Hard yards. Hope was heightened then crashed and burned. Human side of all this. Over a quarter of a million dollars later. My son’s pulmonologist attended his memorial service. Not the surgeon. It was a failure for him. We think we have progressed but the reminder of how little we actually control slaps us around and we realize that we didn’t think of all the possibilities, good and bad.

"...underscored the challenges presented by organisms that are constantly evolving in their effort to survive the onslaught of antibiotics used in medicine and agriculture." How many reasons do we need to stop eating big ag meat?