Prof. Roni Gamzu, the health ministry's director general, publicly discussed the Eltroxin affair yesterday for the first time. Speaking during a discussion by the Knesset's Labor, Welfare and Health Committee, Gamzu said "the company did not want to add warning labels on the [drug's] packages, but we forced it to do so."
Gamzu clarified that the investigation committee established by the ministry, whose formation was disclosed in Friday's Haaretz, will examine failures both in the ministry's actions and in the company's performance. "I don't want to give details, but we are very dissatisfied with the company's actions," said Gamzu.
Members of the Knesset committee called on Gamzu to take steps to eliminate impediments that stop health maintenance organizations from enabling patients in upcoming weeks to obtain alternatives to Eltroxin. The HMOs have recently indicated that patients who seek alternative medicines are being required to obtain various clearances and undergo tests; among other reasons, this is because the drugs are very expensive.
Up to now, only the Kupat Holim Clalit HMO has stocked up on the alternative medicine Euthyrox; other HMOs currently face shortages of these alternative medications. Health Committee chairman MK Haim Katz stated: "At this point, the Health Ministry must authorize alternative medicines so that patients will not need to obtain approvals from the head physicians in districts; it should suffice for a patient to receive authorization from his own attending physician."
Up to now, the Health Ministry has received 450 complaints about side effects suffered by patients after they took the new version of the Eltroxin medication. The composition of this drug was altered in February 2011; but the company waited until August this year to put warning labels on the drug's packages - and it acted only under Health Ministry orders.
Eltroxin addresses thyroid gland ailments; some 200,000 Israelis, most of them women, use the medication.
During the Knesset hearing, Gamzu provided details about the investigation committee established by the ministry. He declared that "we want to broaden the investigation, and clarify whether these actions could have been implemented in a different way, whether disclosure to the public could have come earlier, and whether reports to doctors should come directly from us, the ministry, rather than from the company."
Gamzu added that the committee can reach an array of decisions, including one banning the provision of prescriptions for Eltroxin in Israel; however, he indicated, such a decision is unlikely, since this drug has never been taken off the shelves in any country where it was marketed, and is currently widely sold in more than 20 countries. Gamzu promised that this investigation committee will hold its hearings quickly; he was invited by the Knesset to appear in January, to report on the committee's recommendations. The committee will including members who are not Health Ministry officials; these will including three physicians.
A senior Health Ministry official said yesterday that in the aftermath of the Eltroxin controversy, the ministry is likely to toughen up monitoring of drugs' side effects, in keeping with strict standards upheld in Western countries. He said that "this is a very problematic product because it has side effects, and up to now there have been no alternatives for it in Israel."
Eti Noy, who lives in Israel's south, stated at the hearing that she has launched a Facebook page related to Eltroxin, and it has received 3,000 complaints from users about the product's side effects.
MK Ilan Ghilon (Meretz ), who uses the drug, testified that "we patients feel helpless. I am worried about those who are not aware of the side effects, and who were affected by [the drug] yet have not reported problems. I use the medicine, and nobody warned me about it."
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