Pharmacology

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Thursday, September 18, 1997

Health Ministry, FDA Recall Two Diet Drugs

JERUSALEM (September 18) - Popular diet drugs taken by several million Americans and 1,500 to 2,500 Israelis have been taken off pharmacy shelves here and abroad. The drugs, generically known as fenfluramine and dexfenfluramine, are suspected by the US Food and Drug Administration of causing defects in the heart valves of some obese patients who took them.

The unusual FDA recall two days ago - the first drug is on the market since 1973 and the other since last year - led the Health Ministry to make a similar move.

Dr. Yair Gibor of Abic, the local importer, said yesterday that anyone with packages of fenfluramine tablets (commercially known as Ponderax) or slow-release capsules (Ponderax Pacaps) should bring them,sealed or opened, back to their pharmacy for a refund.

The ministry has also barred pharmacists from preparing the drugs from raw materials.

Dexfenfluramine, which is sold in the US as Redux, was never approved for sale here. At least three deaths linked to the medications, marketed by Wyeth-Ayerst Laboratories, have been reported in the US. The drugs have been prescribed to obese Americans in combination with phentermine, which may still be sold here but is much less effective on its own. The combination is known as Fen-Phen. According to Health Ministry pharmacist Rahel Gutman, Fen-Phen is not banned in Israel although it is not a widely accepted treatment.

The FDA examined a report in July from the Mayo Clinic that said 24 cases of a rare disease of the heart valves had been detected in patients taking the diet drugs. Since then, 66 more cases of heart valve abnormalities were reported in the US, but the patients did not suffer characteristic symptoms, such as shortness of breath, palpitations, extreme fatigue, swelling of legs and heart murmurs. The FDA also declared there was no evidence that phentermine was unsafe.

The diet drugs affect the neurotransmitter serotonin in the brain, which is believed to influence how satisfied people feel after eating.

Dr. Earl Harow, a US-born general practitioner who has treated 70 to 80 obese patients in his Jerusalem clinic since January with fenfluramine, said he would immediately stop prescribing it.

He said that "the decision to recall was correct, given the fact that a significant number of patients who took them [the drugs] had signs of heart valve problems, even if most were without symptoms."

Harow hoped that other diet drugs in the pipeline would be available soon. "Doctors who treat obesity - not five or 10 extra kilos but a body-mass index of 30 or more - are saddened to see patients struggle with their weight. In the US alone, 300,000 people die of obesity each year.

"The fenfluramine gave patients a feeling of satiety for the first time in their lives; they were then able to change their lifestyles, exercise and observe a healthier diet," he said.

Both Harrow and Gibor said they knew of no heart-valve complications among Israeli patients who took the drugs.

By JUDY SIEGEL, Jerusalem Post.

Tuesday, March 25, 1997

Teva Medical, Israel International Fund, 
Taoz in joint venture.

TEL AVIV (March 24) - Teva Medical, Israel International Fund, and Taoz announced plans yesterday to invest $4.5 million in a joint venture to establish community medical centers internationally.

Using Teva Medical's developments, the centers will provide dialysis treatments for people suffering from kidney ailments.

According to international figures, 500 out of every one million people worldwide suffer from kidney problems and require dialysis treatments two or three times a week.

"We believe community dialysis centers answer a basic need that unfortunately will grow rather than disappear in the coming years," said Isaac Davash, director-general of the Israel International Fund. "Teva Medical has interesting know-how not yet found in the marketplace."

The six-month-old, $30m. fund, a joint venture between Bank Discount and the UK's Hambros Bank, invests in Israeli firms whose products mostly go for export.

Teva Medical, a subsidiary of Teva Pharmaceutical Industries based in Ashdod, manufactures and markets medical devices. In addition to dialysis treatments, it makes products used in blood transfusions, blood banks and home treatments.

Taoz is a local private company that provides medical services.

The joint venture's first center is scheduled to open in an undisclosed European country within the next two weeks.
By JENNIFER FRIEDLIN, Jerusalem Post.

Thursday, January 9, 1997

IDF Using Soldiers As Guinea Pigs In Nerve Gas Antidote Ttests.

TEL AVIV (January 9) - The IDF admitted yesterday that it has been testing a nerve gas antidote and other drugs on soldiers for decades, but dismissed charges that soldiers are forced to participate in the experiments.

OC Medical Corps Brig.-Gen. Yehoshua Shemer said recruits today are being used in medical experiments, but only on a voluntary basis and soldiers must sign a waiver to participate.

"There are no secrets here," Shemer said, adding that the drug being tested was Pirsiglobin. "It protects against the very grave effects of nerve gas. If you take it before being exposed it neutralizes most of the serious effects of nerve gas."

Shemer's statements came following a report on Israel Radio that soldiers were forced to take drugs in the 1970s and 1980s, some of which were reportedly banned. Recently, Givati soldiers have been involved in the latest experiments and their parents have urged them to quit, Israel Radio said.

The army declined to comment on the matter and referred all queries to the radio interview given by Shemer. Shemer said any and all medical research in the IDF is first approved by the Helsinki Commission on Human Rights. He also admitted that there were other experiments being conducted as well.

He said the nature of the drug demanded that soldiers be tested in pressure situations and that recruits presented the best suitable group. He said medical checks were done two months after the experiments to determine if there were any side effects, but none were found.

"We are six years after the Gulf War. At that time, when we did not have solutions to the threat [of chemical attack] we were very severely criticized. It is important for the public to know that we continue to increase our capability to present a package of protection that not only protects, but also neutralizes" the threat, Shemer told Army Radio.

He said that soldiers had the right to refuse to participate and that 30 percent had chosen not to be part of the latest experiment.

But some participants said those who volunteered for the experiments were absolved from guard duties and were not bothered by the base sergeant major, which was a form of payment.

Following the initial report, dozens of people telephoned the radio station saying they too had been subjected to the experiments and that any trace of the research had disappeared since it was not noted in their medical file.

"They forced us to take these pills three times a day," said Alex Shamir, who was in the armored corps in the early 1970s. "The commanders stood and watched to make sure we swallowed them." Shamir said he suffered from diarrhea and nausea.

"We didn't sign any consent form. They just took us as guinea pigs and forced us to take it," Shamir said.

Shemer said records today are meticulously kept, but he couldn't speak for what happened 25 years ago.

MK Alex Lubotsky (Third Way) said he had sought clarifications from Defense Minister Yitzhak Mordechai and was seeking to raise the issue in the Knesset Foreign Affairs and Defense Committee. He maintained that even though participation was voluntary, 18-year-old recruits were not always confident enough to make the right decision.

"A recruit in basic training doesn't have real freedom. He wants to be OK with his commander and he is also under strong peer pressure," Lubotsky said. "There's a lot of competition to get into Givati. They are very gung-ho. They are so highly motivated that they always want to make the best possible impression," Lubotsky said.

Liat Collins adds: 
Lubotsky stressed yesterday that despite his criticism of the IDF, the situation in the 1990s is entirely different than in the past. He also reminded the public that the experiments are carried out with the authorization of the Helsinki Committee.

He also condemned the lack of medical records pertaining to the experiments in the soldiers' personal files. He called for new regulations to be set by the Knesset Foreign Affairs and Defense Committee, which would be relevant specifically to military personnel and would operate alongside the Helsinki Committee recommendations.