An obsolete state regulation makes it difficult for community institutions to carry out valuable health studies.
By JUDY SIEGEL-ITZKOVICHDr, Deena Zimmerman(photo credit: Judy Siegel-Itzkovich)
The public at large – and apparently the Health Ministry as well – seem to think that all medical research is conducted in hospitals. But they are wrong. A Jerusalem-based network of private urgent-care clinics – TEREM – has for six years been conducting valuable research based on anonymous data collected from the approximately 250,000 patients using its facilities each year. It has published the results in important medical journals, providing objective information to relevant medical practitioners in Israel and abroad.American-born pediatrician Dr. Deena Zimmerman – TEREM’s research director, who also treats children at its Jerusalem headquarters and runs a private practice out of her home in Nof Ayalon – says it takes three to six months to get approval for each project.In an interview at TEREM’s Romema headquarters with The Jerusalem Post , Zimmerman explained that the delay is due to the ministry’s regulations governing research on human subjects. Only in Israel, she noted, is this process known as “Helsinki” – referring to the Declaration of Helsinki, first adopted by the World Medical Association in Finland in 1964 as a set of ethical principles regarding human medical experimentation.The document, which has undergone numerous changes and clarifications, was inspired by the 1947 Nuremburg Code following the Nazi-era horrors. While not legally binding according to international law, every country sets down rules for approval in advance of “human medical experimentation” – even if only anonymous statistical data is used and no one lays a hand on a patient or administers medication.An obsolete 1980 regulation on human medical experimentation does not take into account the ability of community facilities – public or private – to properly conduct medical research. The small amount of research carried out through the public health funds are arranged by hospitals. But as private clinic researchers have not been considered by the ministry to be a relevant category, Zimmerman has had to go to her friends at Jerusalem’s Shaare Zedek Medical Center for a favor to get approval. That arrangement has continued.Asked to comment, ministry associate director-general Dr. Boaz Lev conceded that the regulations are out of date. “We have been working for three years on primary legislation that would make it possible to conduct medical research not only in hospitals and not only by public institutions,” he said. “But it will take more time. We want eventually to make the approval process simple.”Zimmerman first met TEREM founder Dr. David Applebaum – who was murdered with his daughter Naava in the infamous 2003 terror bombing of a Emek Refaim Street cafe on the eve of her wedding – when she was a child visiting Israel. Knowing of her deep interest in medicine, Applebaum – who at the time of his tragic death was director of the emergency department at Shaare Zedek – promised that “when” she became a physician and made aliya, he would hire her at TEREM. The private chain has urgent-care clinics in Jerusalem (the Romema main office and a newer one in the Arnona quarter); Ma’aleh Adumim, Modi’in, Beit Shemesh and Ramat Gan/Bnei Brak.A graduate of Yeshiva University’s Albert Einstein Medical College in New York, Zimmerman settled in Israel 16 years ago with her husband Rabbi Shalom Zimmerman, a social worker, and began to work for TEREM immediately. They have five children, aged 10 to 24.The pediatrician conducted her first research study with Applebaum, and has also supervised research conducted by his son Dr. Yitzhak Applebaum on patients diagnosed with suspected heart attack at an urgent-care clinic who nevertheless refuse to go to a hospital emergency room.“I think there needs to be a ‘free Helsinki,’” in which people who do not meet the criteria by working for a hospital or a health fund be allowed to get approval for research on human subjects,” she suggested. “The procedure must be easy and accessible, and involve very simple forms. After all, we are working on stored data, not conducting clinical medical experiments. Such a process would be incentive for research in the community.”
Applebaum, she said, “was always interested in quality and research. After my medical residency at Rutgers University in New Jersey, I did my master’s degree in public health, and David was my inspiration. Doing research is something that gets into your blood if you like to do it. In 1992, still in the US, I did research with him, going through 900 medical charts, on the re-visit rate to TEREM clinics compared with urgent-care clinics in the US. But I couldn’t find any such research in the US, so I did it. TEREM came out very well in comparison to the US clinics. Our study was published in the Pediatric Emergency Care journal.”With David Applebaum gone – although his photograph is prominently displayed on the wall in the Romema clinic – deputy TEREM director Dr. Nahum Kovalski chose Zimmerman as research director and encourages her and the staff to do studies using the company’s statistical data. Israeli medical students also participate, as do American students who come to Israel to study Torah but also want experience in the community as interns and know it will add to their resumés when they pursue degrees.So far, dozens of research projects have been carried out and medical “poster sessions” for medical conferences prepared at TEREM, which subsidizes the work itself even though there is no requirement to do so.Zimmerman noted that working for a health fund and conducting research on her own, she was never compensated. “I had to take days off from my health fund clinic work to go and present research at conferences and meetings. This would be unthinkable in the US, where research in the community is highly respected; I would have gotten time off that was not at my expense.”One of the most important findings in TEREM research involves guidelines issued by the Health Ministry in 2006 that stated there was no need to perform chest x-rays to confirm a diagnosis of pneumonia if clinical signs of the lung infection are detected. But this, said Zimmerman, means there is unnecessary use of medication.“My guess from experience was that about 50 percent of people who show clinical symptoms do not have pneumonia,” she said.“We sat down and did a retrospective study whose goal was to quantify how many children with clinical signs of pneumonia would have been given superfluous antibiotics treatment if the x-ray had not been performed – going through a year’s work of clinical signs of pneumonia and chest x-rays conducted at TEREM. Then we compared the results with a study in a US emergency room. We found that 48.7% of those with clinical signs did not have pneumonia.”For the prospective study, Zimmerman and her team used only very experienced, board-certified pediatricians whowrote down the findings in real time. “They didn’t know the purpose of study, but we found that nearly half would unnecessarily have given antibiotics. This study will also be published in Pediatric Emergency Care.”Of the 3,343 children examined for pneumonia over a year, 877 had showed clinical symptoms upon clinical examination. Of these, 433 had normal chest x-rays. Thus the researchers concluded that reliance on a physical examination alone to diagnose pneumonia in children may result in overdiagnosis and that new guidelines should be considered.Last August, she continued, the Infectious Disease Society of America also said in a statement that x-rays to diagnose pneumonia in the community are unnecessary and can be replaced by giving antibiotics. “We want to reduce the performance of x-rays, but we also want to minimize bacterial resistance to antibiotics, which is potentially very dangerous, as it reduces the effectiveness of the drugs when they are really needed,” she said.TEREM researchers’ findings have influenced the way suspected pneumonia is treated here, she said. The US medical establishment reacts to official guidelines much more slowly than the Israel one. Doctors are independent, and the healthcare system does not often react on a national level. In Israel, clinical guidelines are regarded much more seriously, said Zimmerman, noting that most pediatricians and family physicians have adopted the “wait-and-see” guidelines of not prescribing antibiotics immediately when a child is diagnosed with an ear infection. In most cases, the child recovers and does not suffer much without them.She also supervised two studies on the overtreatment of throat infections (pharyngitis) with antibiotics. “When our doctors diagnose a case of Streptococcal infection of the throat at one of our clinics, the computerized file has a pop-up box that requires them to write exactly what they have done. If a doctor hasn’t first done a throat culture before giving antibiotics, he gets a message from Nahum Kovalski asking for an explanation. We are constantly trying to raise our quality of care.”She added that despite myths – even published in medical textbooks – that toddlers under the age of three years do not get “strep throat,” TEREM research has shown that it can occur in this age group.Another subject under the TEREM magnifying glass was fever in the elderly. Fever in young children is treated very seriously by doctors here, while a high temperature (not due to cold or the flu) in old people is generally not. But Zimmerman, who has just presented the new research at an emergency medicine meeting, said the chances of anybody over 60 who has a fever having a serious illness is high.“It could be pneumonia, urinary tract infections, cellulitis [a bacterial infection of the skin that can cause complications in the limbs or internal organs] or other potentially serious conditions,” she warned.“It is unfortunate the medical establishment believes that everything important in research goes on in hospitals. There is a whole healthcare system in the community.Patients prefer to be near home and with their families rather than lying in a hospital bed. Even intravenous antibiotics can be done in a community clinic. I am a general pediatrician; I want to treat the whole child. Generalists have a lot to contribute, as do specialists. Both deserve equal respect.”As for community research, she said, there are still too few medical students working in the community. “It’s better than before, but not enough. It is not only pediatrics but other fields as well. It’s better for patients if they are treated by doctors in the community, and its better if medical students learn there in addition to clinical studies as frontal teaching in hospitals,” Zimmerman insists. “If you want to know what is going on in healthcare, you have to know what is happening in community facilities. It doesn’t require a huge budget for research there, but important information results. The problem is that there are no incentives.”Young American medical students and pediatricians are typically taught in the community about prevention of disease and identifying the new type of children’s disorders – not just infections, congenital disorders, broken bones and the like but also those that combine psychological and developmental problems, Zimmerman said.Immigrant doctors from the US who were trained that way could speed up an increase in the number of much-needed physicians by beginning in community work, she said.“Residents studying pediatrics are mistaken if they look only at hospitalized kids. They are all sick. It looks different from the community, where there are healthy, normal kids who have some problem that can be taken care of locally. Work that adds up to 300 hours a year compares to one shift in a hospital ward. If young doctors get incentives to work in the community by getting time off to do research, all will benefit,” she concluded.
