Phage Article from Heet Parool
Susanne de Goeij was just featured in a newspaper article in the Netherlands, she's translated the article for us.
A few side notes before we begin the translation: I don't agree with the facts that they imply that HS is a bacterial disease, bacteria with HS is not the cause, but can be a secondary problem.
I asked them to explain in the article why phages work with HS (they destroy biofilms, work as an anti-inflammatory, restore the microbiome and modulate the immune system), but the journalist thought that was to confusing for the readers. I did my best to get it as informational and factual as I could, but I did not have full control over the article.
Bacteriophages: Rules Obstruct Medicine Research
Suffering from bacterial disease is avoidable. Painful ulcers, permanent fatigue and disability. The skin disease hidradenitis suppurativa (HS) spoiled the life of Susanne de Goeij. Since treatment with bacteriophages in Georgia, she has virtually resolved her symptoms.
"I sat in my bath twice a day for three hours," says De Goeij (Apeldoorn, 1986). “That helped against the pain. But I couldn't ride a bike. Neither was it possible to wear jeans, because of the severe flare-ups on my groins and buttocks. Now I can go to the playground again, with my daughter. "
We are sitting in the living room of De Goeij in Amsterdam. She serves coffee. Buddha images around us, a wall with CDs and children's toys. Her boyfriend went on a walk with their 6 year old daughter. De Goeij has displayed the medicines that she has been using since April with a amazing result.
Six months ago De Goeij sent an email to the newspaper to see if we wanted to write about it. Through a crowdfunding campaign she had collected 8,000 euros for a bacteriophage treatment in the famous Eliava clinic in Tbilisi. We decided to follow the case. The result of the treatment would be the deciding factor.
De Goeij (32) has had this skin condition since she was thirteen. She visited five Dutch dermatologists, but it went from bad to worse. The skin problems also caused psychological problems. In 2008 she received a Wajong benefit. She has been declared unfit for work for the rest of her life.
De Goeij underwent minor surgery to cut the lesions and she used an arsenal of medication: Roaccutane (for acne), prednisone (anti-inflammation) and many antibiotics, which brought no improvement, a short-term improvement, or the improvement was accompanied by nasty side effects.
She heard from her father about the Georgian phage clinic. De Goeij immersed herself in all the information she could find, and has since become a big phage fan.
De Goeij went to Tbilisi in April. She was treated there for eleven days. The doctors investigated which bacteria were present and they looked for the matching phages. Her wounds were cleaned and treated with phage cremes. She took phage pills and phage drinks. Within five days she saw the first results, which continue to this day.
De Goeijs life has progressed by leaps and bounds. She has almost no more inflammations. Deep sores have disappeared or have been replaced by a light red stripe on the skin, and most important,she got rid of the pain and she likes life again.
De Goeij does not consider herself cured. In theory you can stop phage medication when the pathogenic bacterium is killed, but De Goeij continues to use the medication. It costs her around 2000 euros on an annual basis, the health insurance company does not reimburse anything, but she does not want to take the risk of her skin disease returning.
It is "Incomprehensible that phage medication is not reimbursed," she says. “It helps, costs 2000 euros a year and has no side effects. I could use Humira. That is reimbursed, but has more serious side effects and costs 14,000 euros per year. "
De Goeij buys the phage medication in Georgia. They have them delivered in Belgium, because Dutch customs intercept the pills, ointments and drinks as illegal medicines. She then drives the medication to Amsterdam by car.
De Goeij finds it incomprehensible that thorough research into phage medication is not possible. After all, what helped her can help others. For her trip to Georgia, she presented herself as a test subject for scientific research. The HS research team of the Erasmus Hospital in Rotterdam showed interest. The doctors are not allowed to touch De Goeij's phage medication, but they are allowed to study her skin. "It is a study of one test subject," says De Goeij. "That is a small study, but its a start." The results of that study are not yet known.
What are bacteriophages? Bacteriophages, or phages, are viruses that attack bacteria. Phages are natural enemies of bacteria. They are wherever bacteria are: on and in the human body, but also in the sewer and in the forest. Because they kill bacteria, you can use phages to combat diseases caused or combined by bacteria.
Phages help against infections of the skin, throat and intestines, the Dutch government establishes this through the National Institute for Public Health and Environmental Hygiene (RIVM). They are also used in foreign clinics against, for example, bladder infections, eye, ear and throat infections and bacterial respiratory diseases. Phages do not help against the borelia bacterium, which causes Lyme disease.
Bacteriophages were discovered about a hundred years ago as a medicine, approximately at the same time as antibiotics. In the Netherlands and other Western countries, however, phages are rarely used. Antibiotics are the main means of killing bacteria. Phages and antibiotics both fight bacteria, but they do so in a different way. The use of antibiotics is faster and easier.
An antibiotic works like a kind of bomb carpet: a group of bacteria is destroyed, including bacteria that benefit humans.
Phages work like a precision bombing: the phage only kills the pathogenic bacterium. Phages are therefore more cumbersome in the healing process. A doctor must first find out which bacterium exactly causes the disease, and then a specific phage must be found. There are phage banks, which store phages and record which bacteria they work against.
Due to the success of antibiotics, phages in the West have fallen into oblivion, however, due to the lack of antibiotics in countries such as Poland, Georgia and Russia, medical professionals have used more bacteriophages there. They are prescribed in pill form, but also as a drink, ointment or catch-up medication. Phage research in those countries does not meet Western standards.
Phages are interesting in combating a growing public health problem: antibiotic resistance. More and more bacteria have adapted to antibiotics, so the medication no longer works. Every year, some 25,000 Europeans die from antibiotic resistance and that number can rise to millions in the future. Phages can be effective in killing resistant bacteria and are therefore an important medicine for the future.
Research into the potential of phage medication is hampered in the Netherlands by regulation. "The government must be bolder," says doctor microbiologist Marc Bonten. Bonten is affiliated with UMC Utrecht, has medicinal phages in his laboratory, but is not allowed to make medication that he gives to patients for systematic research. "Very frustrating," he sighs. Phage medication can offer a solution for patients who are stuck in the regular circuit. Bonten receives letters every week from patients. He may give an individual patient phage medication, he does that occasionally, but he is not allowed to conduct systematic research. "It drives me insane," he says.
The frustration of Bonten and his patients is well understood. Phages cure infections of the skin, throat and intestines, the Dutch government acknowledges through the National Institute for Public Health and Environmental Hygiene. Phages are not hocus-pocus, which you have to believe before it works. There is a scientific basis for seeing bacteriophages as a medicine, only we still do not know enough about the correct composition, quantity and combination of phage medication.
"That phages are seen as medicine is precisely the problem," says Bonten. They, therefore, fall under the rules of the European Medicines Agency EMA. It requires phage medication to be manufactured according to strict guidelines, the so-called Good Manufacturing Practice (GMP). However, the medication that Bonten has in his office do not meet this requirement. Georgia, where a lot of phage medication comes from, is outside the European Union and is separate from EEA guidelines. "Medication that is not produced according to GMP rules is not allowed to be systematically investigated by the Dutch government," says Bonten. “And at the same time, the government says that we still know too little about phage medication to be able to use it. It is a complete Catch 22. "
The Netherlands has put phage medication on the map by TVshows like Radar and Dokters van Morgen (doctors of tomorrow) . The television programs followed patients like Susanne De Goeij to foreign clinics, as hundreds of distraught Dutch patients do every year. "Sometimes with startling results, but you also hear bad stories," says Bonten. “Like a woman who had to be admitted to the hospital because the phages did not help. Or the story of a patient who did not improve after two phage courses. A third therapy of thousands of euros was needed, a waste of money. That is why good patient research is so important. "
The state of scientific research into phage medication abroad does not meet Dutch standards. That is why phage medication legislation in Belgium has been simplified this year. Even without the use of GMP rules in production, phage medication is used and investigated for bone and burn infections. "They can save lives," says trauma surgeon Willem-Jan Metsemakers of the University Hospital in Leuven; forty patients have already benefited.
The Belgian Rob Lavigne has been involved with phages for 20 years. The genetic engineer of the University of Leuven got involved via a Russian scientist and has since been convinced of the potential, but Lavigne does not know whether the large-scale use of phages can be a success.
Lavigne foresees problems with the profit model. The pharmaceutical industry cannot really be bothered, he says. Phages are a natural product, which makes it difficult to patent. The medication also varies from patient to patient, and phages, in contrast to blood pressure inhibitors, for example, are not usually prescribed in the long term. "In this way the basis under the earnings model is useless," says Lavigne.
Bonten also realizes that, but he wants to investigate phage medication on behalf of the patient. Making phage medication yourself according to GMP regulations is not feasible, he says. This requires an investment of more than 10 million and UMC Utrecht does not have that money. Bonten lobbies the government tiredly. "Minister Bruins should be bolder," says Bonten. “Why does the Netherlands simply decide not to deviate from the EMA directive? Patients would be greatly helped with that. "
Mucked by Dutch regulations, Bonten is now about to work with an American company - Armata Pharmaceuticals - that says it has prepared phage medication according to GMP prescriptions. “The contacts have so far gone via the internet. We have never seen those people from Armata in real life, but who knows their pills will give us the chance for good research. Its about time ”
According to Minister Bruins (medical care) patient safety is the reason that phage medication should not be conducted on patients in the Netherlands, but even without GMP guidelines we can make safe phage medication, says Lavinge. Bonte confirmes that.