drug companies and doctors battle over the future of fecal transplants
A new war is taking place in the health care sector, which concerns hundreds of millions of dollars and balances the lives of thousands of people.
The battle to get pharmaceutical companies to fight against doctors and patient advocates is fighting for the most unlikely substance: human feces.
The conflict is about the future of fecal microbial population transplant. M. T.
A revolutionary treatment that has proven to be very effective in the treatment of clostridiides is difficult, a serious bacterial infection that kills 500,000 of Americans every year in 30,000.
This therapy transfers the feces of healthy donors to the intestines of sick patients, restoring beneficial work on the intestinal microbial community killed by antibiotics.
Scientists believe there is potential to use these organisms to treat diseases from diabetes to cancer.
At the heart of the controversy is the classification question: What is the fecal microbial population that treats C?
Distinguish between drugs, or are they more similar to organs, tissues, and blood products that are transferred from healthy people to treat diseases?
The answer will determine how the Food and Drug Administration regulates this process, what it costs, and who can make a profit. [
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| Sign up for the Science Times newsletter. ]In 2013, the F. D. A.
A draft decision was announced to regulate treatment as a new drug, but said it would continue to look into the matter before a final decision was made
This is expected to happen soon.
Critics say the approach is based on outdated science and could lead to increased costs for patients, most of whom are currently dependent on a non-profit stool bank in Cambridge.
Some researchers say that what is at stake is the future of pioneering therapies that leverage the human microbial population --
Trillions of organisms settle in the body and are increasingly seen as key to healthy brain development and immune function.
\"There are good reasons to worry, because for many patients, stool transplant is a matter of life and death,\" said Catherine Duff, founder of the patient group stool transplant Foundation.
\"The concern is that the greed of the company will hinder the access of patients. ”As the F. D. A.
Both sides are stepping up pressure towards a final decision.
More than 40 well-known stomach specialists and infectious disease doctors have recently written to the agency urging it to rethink its approach. Dr.
Alexander Holt, a stomach scientist at the University of Minnesota, said he was worried about F. D. A.
In support of what he calls the \"poo drug cartel,\" a group of companies seeking approval for a new method of delivering active ingredients in transplanted feces.
The three companies, Rebiotix, Seres Therapeutics and Vedanta bioscience, have raised tens of millions of dollars from investors who recently formed an association with F. D. A.
\"Companies that are trying to profit from profits created by nature are investing a lot of money around,\" said Dr. Khoruts.
\"I don\'t think there are obvious villains here, but I am concerned that regulators are not keeping up with the latest science and that the interests of investors may exceed those of patients.
Executives at pharmaceutical companies and some doctors believe that this drug model will help ensure the effectiveness and long-term safety of the drug.
A term safety of therapies that still know little about their mechanisms.
\"The first principle of medicine is that there is no harm, and we don\'t have a long time at the moment.
The semester record of F. M. T.
Adverse effects . \"
Sahil Khanna, associate professor of digestive medicine at Mayo Clinic, conducted an industry study
Funding for clinical trials of stool transplants.
\"We also need to move poop from one person to another.
\"Experts and many doctors in the field of bioethics are putting pressure on the FBI. D. A.
Propose a new regulatory category that reflects the pioneering nature of microbial group therapy.
Like the prescription drug price dispute, as described by a doctor, the \"poop war\" reflects the long term
Tensions between pharmaceutical companies and patients on health care in the United States.
Human feces have proved to be a potential gold mine for medical researchers and drug manufacturers.
According to the analysis company global data, the drug market
Basic treatment of C.
Diff is expected to reach $1.
By 2026, it was $7 billion, up from $0. 63 billion in 2016.
This growth has to do with the surge in C.
This is parallel to the excessive use of antibiotics, making patients more susceptible to infection.
Inspired by the success of C stool transplant
The difference is that scientists are racing to develop similar treatments for a range of diseases and disorders, including obesity, autism, UC, Alzheimer\'s and Parkinson\'s.
Investors have also noticed that they are putting tens of millions of dollars into start.
Ups is chasing the next microbial breakthrough.
\"The whole stadium is screaming faster than anyone thinks,\" said Li . \".
Jones, ceo of Rebiotix, is testing two products that treat C. diff.
\"It is possible for the microbiology group to change the way we view and treat the disease.
\"This boom is far from what researchers experienced when they first tried to sell the therapeutic capacity of human feces.
Mark Smith, a microbiology at the Massachusetts Institute of TechnologyI. T.
When he was with a group of pharmaceutical company executives, one of them interrupted him and asked if the meeting was a prank.
\"I can\'t believe you wasted my time on this crazy idea,\" he said . \"
Smith later recalled. That was 2012.
Later in the same year, he helped discover openbioome, a non-profit stool bank that now provides most of the feces for transplant in the United States.
Three years ago, he started his own pharmaceutical company, Finch Therapeutics, raising $77 million.
In the past decade, thousands of Americans
Through a stool transplant, diff has been cured and usually a single dose allows the patient to recover from the edge of death.
According to several studies, this treatment has a success rate of more than 80%, and many patients feel better within a few hours of receiving surgery, which is usually performed by colonoscopy or capsules containing dry feces. The F. D. A.
The treatment has not been officially approved yet, but it has suspended the implementation of the rules for patients whose antibiotic treatment has failed, while it comes up with the best way to regulate the treatment until recently, sometimes carried out by desperate patients at home with enema, salt water and the feces of relatives. Ms.
C\'s head Duff.
The Diff patient group attributed herself to her husband\'s homemade mixture in the kitchen blender with her own stool. The F. D. A.
Declined to comment on the article.
Many insurance companies will not bear the cost of treatment until the agency finally makes a decision.
Treating stool transplants like a new drug requires pharmaceutical companies to submit the proposed product to an exhaustive investigation procedure to assess its effectiveness and safety, which can cost millions of dollars.
Critics fear that the deal will allow a pharmaceutical company to receive exclusive sales rights for up to 12 years of stool transplant treatment, a move they say will hamper innovation.
Some are also concerned that patients who are unable to pay for the company\'s proprietary treatment may turn to home therapy, putting them at risk of not screening pathogens in their feces.
At present, most of the materials used in the stool transplant are from OpenBiome, the public stool bank in Cambridge, which accepts its mission in a humorous and solemn way.
The huge poo emoji is decorated with its office, the meeting room is named after the section of the intestines, and the staff birthday cake always has a taste: chocolate.
The organization produces 900 to 1,000 treatments per month, most of which are bottled liquids packed with dry ice and delivered overnight to clinics across the country.
Any unpleasant smell is limited to a closed production facility, and employees wearing a white hazmat suit carefully handle clear plastic bags filled with mudcolored slurry.
These materials come from donors who earn $40 and they have to go through intensive screenings and regular medical examinations.
\"It\'s harder to be a stool donor than to enter M. I. T.
\"The head of the group, Carolyn Adelstein, said. In 2012, Ms.
Edelstein and Dr created openbio me together.
Smith is now her fiancé as her cousin is infected with recurrent cancer.
Face a 6-
After a month of surgery, I used my roommate\'s stool at home.
A few months later, they started openbioome with the fund\'s seed funds and sent out six treatments in the first year.
\"It\'s a crazy journey,\" Ms.
Edelstein said she showed a room full of huge freezers with thousands of screened samples of feces.
But OpenBiome and other stool banks face an uncertain future.
Pharmaceutical companies have been working to introduce patients to the clinical research required by F. D. A.
Approved, it is hoped that federal officials will limit the ability of stool banks to distribute feces, and that more patients will be expected to participate in their trials. The F. D. A.
Increased regulation of OpenBiome production has led to stricter testing and higher prices, which will double this month to $1,600.
Patient advocates expect that if F. D. A.
Granted market exclusivity to one of the companies, which is in the final stages of testing a replacement for the original stool transplant.
\"It is very frustrating to see that over-regulation destroys one good thing in health care again,\" said Dr.
Colleen Kelly, a gastrologist at Brown University School of Medicine
Her patients are as worried as she is.
Stephen Shaw, 66, a retired truck driver, was tied to the toilet most of last year. diff. A diabetic, Mr.
Shaw acquired intestinal disease in many ways: during hospital stays, a series of infections treated repeatedly with antibiotics.
He recalled that he had dirty himself many times and said, \"I can\'t go anywhere because I\'m afraid I\'ll explode . \".
\"My life was ruined.
Mr. Kelly had a stool transplant through a colonoscopy, within hours.
Xiao began to feel better.
By Christmas, his stool had returned to normal.
\"I never thought the solution to my nightmare would be so simple,\" he said . \".
\"I just hope that big pharma companies don\'t afford people like me.