Tel Aviv dental school accused of conducting experiments on humans, animals
Most of the research conducted in the last 10 years has tested the effectiveness of a treatment to regenerate bones following teeth implants.
Scientists are allegedly carrying out cruel and unnecessary experiments on cats at the Tel Aviv University medical school. This came to light after photographs of two frightened, abandoned kittens in Tel Aviv University's animal laboratory reached Behind Closed Doors, a non-profit organization that advocates the rights of animals used in experiments in Israel.
The ensuing examination led to committees of inquiry probing complaints filed about experiments conducted on human subjects, including an apparently forged complaint letter and a recent complaint to the police about the goings on in the university's medical school.
The photographs of the kittens were reportedly taken via hidden camera in March 2009.
"The kittens were in a filthy room ... one lay in a tub of its own excretions and could not move, the other clung close to the tub with horrified eyes," said Anat Refua, chairwoman of Behind Closed Doors.
"The treatment chart in the room indicated they had been kept there for at least eight months," she said.
The group found that most of the university's experiments on cats in the past decades have been held by TAU's dental school. Another examination, conducted jointly with the National Council for Animal Experiments, found that Prof. Zvi Artzi, a senior researcher at the dental school, had been conducting the research through these experiments.
While the purpose of the research is not yet clear, the overwhelming majority of animal experiments the dental school has reportedly conducted over the past decade was to test one product - Ossix.
After the inquiry, TAU abruptly stopped raising cats for experiments.
"Experiments on animals at Tel Aviv University are meticulously conducted and all the research was approved," Artzi claimed. He also said there is no connection between his research and the university's decision to stop breeding cats.
The goings on in the dental school, however, are more complicated than the controversial experiments on two kittens.
This school is the second of its kind in Israel, established after the more prestigious dental school in Hadassah in Jerusalem. It has only recently resumed activity after four years of standstill, during which it was closed to new students due to financial problems and cutbacks.
But Haaretz's examination indicates that since the school reopened, it has been subject to power struggles, intrigue, suspicions among researchers, various inquiry committees and a recent police inquiry as well.
The product Ossix is a synthetic biodegradable collagen membrane, enabling bone regeneration after tooth implants.
It was developed in the 1990s by Prof. Sandu Pitaru of the dental school and orthopedist Matityahu Nof; it was approved by the U.S. Food and Drug Administration in August 2000 and later by the Israeli Health Ministry. At that stage it began to be marketed commercially.
Ossix was manufactured by ColBar LifeScience Ltd, a Rehovot-based company founded by Pitaru and Nof with the support of leading venture capital funds.
The company also modified the collagen for cosmetic use, developing a substance used to instantly fill deep facial contours and wrinkles. At the end of 2006, ColBar was bought by the international pharmaceutical company Johnson & Johnson for $159 million. But in November 2009, Johnson & Johnson closed ColBar for various reasons and stopped producing Ossix. Johnson & Johnson holds the patent for Ossix and its uses.
In December 2009, a month after ColBar was shut down, the dean of the Sackler Faculty of Medicine at TAU, Prof. Yossi Mekori, received a letter of complaint about an experiment on human held in 2005, before ColBar had been sold.
The complaint accused four senior TAU scientists - professors Ofer Moses, Zvi Artzi, Carlos Nemcovsky and Pitaru himself - of conducting a study comparing Ossix with competing products Bio-Gide, produced by the Swiss Geistlich Group and Gore Tex, without the approval of the university's Helsinki Committee for experiments on human subjects.
In June, after receiving a second complaint signed by the same person, Mekori set up a special ethics committee to look into the matter. But Dr. Andre Menache, a veterinarian and consultant for Behind Closed Doors, in whose name the complaints were sent, denies ever having written them.
The demand to approve experiments on human subjects appears in the health regulations of 1980, but until 2006 this demand was applied mainly to prospective experiments. In retrospective research (analysis of findings already gathered ), certain researchers did not ask for the Helsinki Committee's approval.
In 2006 the Health Ministry tightened the regulations and from then on the committee's approval has been required for carrying out retrospective research as well.
The four researchers conducted their study in 2005, and told the ethics committee that the demand for approval did not apply to them.
But according to the complaint, the study was not retrospective but planned in advance, and therefore did require the Helsinki Committee's approval. It also claimed that the researchers falsified the study's findings.
Meanwhile, the university continues to probe the complaints.
"The story looks bad, but in any case this is not an isolated incident," Mekori said. "We receive occasional complaints about studies conducted in the past and we look into them. There's nothing dramatic about it and we will continue to examine the complaint thoroughly."
But Pitaru is demanding that the university suspend the ethics committee's probe and request a police inquiry into the apparently forged complaint letter. He has also asked the university's comptroller to probe the matter.
"Apparently this is a fake complaint letter, but the university is ignoring the severity of the matter and not taking any measures to investigate the falsification or go to the police," he said in his letter to the conptroller.
First humans, then cats
The study the complaint was aimed at is not the only one of its kind. Prof. Haim Tal, head of the dental school, is said to have conducted comparative research with Ossix, one on human subjects, another on cats, in that order.
Tal sued ColBar co-founders Pitaru and Nof in 2003, accusing them of concealing from him information about setting up the company and dispossessing him of his rights and share in inventing Ossix. The suit ended with a financial compromise, but Tal and Pitaru remained on bad terms.
Four years ago, when Tal was selected as head of the dental school again, he included Artzi, Nemcovsky, Moses and Prof. Avital Kozlovsky in his research on Ossix, but not Pitaru. The studies were published in the periodical Clinical Oral Implants Research and reached Behind Closed Doors.
The first study, performed on human subjects and published in March 2008, compares Ossix to Bio-Gide in 52 subjects - 30 women and 22 men. This study was also conducted without the Helsinki Committee's approval.
Dr. Andre Menache, representing Behind Closed Doors, asked the Health Ministry to look into the matter. Following his complaint, attorney Talia Agmon, of the ministry's legal department, examined the issue and found the Helsinki Committee had indeed not approved the study. But she said Tal had told her the study had been retrospective, and therefore did not require approval.
Though the study describes itself as prospective, Tal said it was based on tissue collected from patients about a decade ago, when he was working as a researcher in New York University's medical school.
"The clinical part was based on tissue gathered in routine treatments in New York in 1999 and 2000, after the Israeli membrane was approved for dental use in 1999," said Tal. "This is why the university was not asked to approve the study."
The Health Ministry then decided to stop the examination. "Legally the universities are not unequivocally subjected to the ministry's supervision in experiments, a situation we intend to amend," Agmon wrote.
The study on human subjects found the Israeli product Ossix had a certain advantage over Bio-Gide in terms of durability. But shortly afterward, Tal conducted a study on eight cats with the same researchers.
According to Refua of Behind Closed Doors, there was no need to experiment on cats as well. "For 20 years, the dental school has been conducting brutal experiments on hundreds of dogs, cats, pigs, rabbits and rats," she said. "Most of them are performed on healthy animals and include drilling holes into their jaw bone and implanting membranes. These tests last from three months to three years. As these procedures are performed on humans as a matter of routine, and provide abundant, reliable information, the experiments on animals are redundant."
The experiments, said Tal, were done in the name of science, and had been approved by the committee for animal experiments.
"The experiment on cats was performed after the one on humans, but was intended to answer a new, still controversial scientific question - the behavior of the membranes at a test site where no treatment had been given," he said. "In addition, the membranes were inserted into the cats in a way that did not cause them any suffering."
Whether the cats suffered or not, the test results proved different than those of the tests performed on humans. In the latter experiment, the Israeli product's advantage had disappeared.