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To include or not to include Gliadel


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://www.haaretzdaily.com/hasen/pages/ShArt.jhtml?itemNo=400055&sw=brain+tumor

Posted on: 03/04/2004

To include or not to include Gliadel

By Ran Reznick

An intense debate has been brewing among senior officials of the health establishment over whether to include the treatment for brain cancer in the health services basket.

The Health Ministry's Health Services Basket Committee decided during two sessions in July and November 2003 that Gliadel, a drug used to treat the most serious brain-cancer patients, would not be included in the basket of drugs covered by every Israeli's HMO policy. "It's a medical mistake, an insufferable distortion, an unjustified and frustrating decision," says Professor Zvi Ram, head of the neurosurgery department at Ichilov Hospital in Tel Aviv, and one of the country's top brain surgeons. MK Shaul Yahalom, chairman of the Knesset's Labor, Welfare and Health Committee, joins Ram in calling the decision "arbitrary, one-sided, contrary to medical and professional logic, and causing serious harm to dozens of brain-cancer patients - the committee took a stand between two schools of medical thought in an arbitrary and pseudo-professional manner. Have they put themselves in the place of God?"

These uncharacteristic statements testify to the extraordinary intensity of the dispute that has been going on among senior figures in the health establishment over the committee's decision on Gliadel. The medicine, which is administered in a single dose through a direct implant to the brain (during the operation to remove the tumor), eases the patient's suffering and extends his life by a few months. It is produced by Guilford Pharmaceuticals and marketed here by Medison Pharma. The panel allowed patients with severe brain cancer to continue to receive (subject to a series of restrictions) the chemotherapy drug Temodal, which is administered to patients orally and at home. Temodal is produced by Schering-Plough, and is marketed in Israel by Trading Pharma.

The main contention of the neurosurgeons, and Ram in particular, is that Gliadel, which is more effective than Temodal and causes significantly less suffering to patients, was not accepted by the committee (in their estimate, some 50 brain-cancer patients per year could have received Gliadel). Nor did the panel, chaired by the Health Ministry's director-general, Professor Avi Israeli, accept the explanation offered by the brain surgeons that authorization of the drug would essentially not involve any added financial expense to the health establishment, since it would be given in the majority of cases in place of the competing drug Temodal, which is already included in, and budgeted as part of, the health basket. The committee also declined to accept a Health Ministry opinion that the use of Gliadel in place of Temodal would, in fact, lead to a savings of about NIS 175,000 a year. Under the current status following the panel's decision, patients requiring Gliadel treatment must pay NIS 40,000 out of their own pocket.

Position of the FDA

The argument over Gliadel extends well beyond the professional difference of opinion between the guild of neurosurgeons (who are requesting that Gliadel be added to the basket immediately) and the guild of oncologists (who argue that Temodal is sufficient). It also raises anew some tough questions about the Health Services Basket Committee's decision-making process, including the degree of involvement by drug companies in the process, the intolerable price paid by patients for puzzling decisions made by senior Health Ministry officials, and legitimate professional differences among doctors, which at times spiral into wars over prestige and control.

Last July, the committee decided to add 12 new drugs and technologies to the basket at a cost of NIS 60 million (in 2003 and 2004). The committee decided not to add Gliadel despite encouraging findings submitted to its members, including the positive opinion of Israel's top neurosurgeons and an internal survey prepared by the Health Ministry's division of medical technologies about the drug.

Based on the survey, the administration of Gliadel to patients with a recurrence of severe brain cancer extends their survival rate after six months by 50 percent and their survival time by 33 percent (from two months to 32 weeks), reduces deleterious side effects, and leads to significant budgetary savings - since Gliadel is cheaper than Temodal and the expenditure on attendant examinations are NIS 175,000 less on an annual basis. In this context, Haaretz was informed by the Health Ministry that the survey was only preliminary, and that once it was updated, it in fact demonstrated that the inclusion of Gliadel in the basket would cost about NIS 2 million a year. The ministry did not offer any explanation as to how a NIS 175,000 savings became an added expense of NIS 2 million.

In July, Yahalom called in senior Health Ministry officials and asked them to explain the decision not to add Gliadel to the basket. The ensuing debate revealed the full extent of the sharp disagreement between the neurosurgeons, headed by Ram, and the oncologists, headed by Professor Tali Siegal, who told the committee that she spends 90 percent of her time "treating patients with brain tumors," and that "I find it quite scandalous to try to add this drug to the basket now, when there are very serious questions about whether it is even worth using: As someone who has devoted most of her life to treating these patients, I think that this treatment is extremely problematic, has raised costs, and delays the treatment that gives good quality of life to the patient - Temodal, which is taken at home."

Ram told Siegal that he was pleased to be "in the good company of those who do not understand, along with all the members of the FDA (the U.S. Food and Drug Administration) and the British and Spanish health authorities, which recently introduced Gliadel. "I don't know how things are run at Hadassah, but everywhere else, all of the treatment decisions - about Gliadel, as well - are always made in collaboration with neurosurgeons and neuro-oncologists. Ninety percent of my time is spent on treating neuro-oncological patients, and our involvement with them is not a fraction of the time. We accompany them from the moment the diagnosis is made, until, unfortunately, the death of a large share of them."

Ram added that "the burden of proof is not on Gliadel, because the company carried out, at very high costs, controlled studies on hundreds of patients, which proved the claim and the limited efficacy - I note this in the clearest manner, the limited efficacy - of Gliadel." Conversely, regarding Temodal, he said, "The FDA warned Schering, the manufacturer of the drug, that if they could not produce the data they had promised regarding its effectiveness, it would consider revoking even the limited approval that it gave the drug."

Following the Knesset debate, Yahalom asked the committee to hold an extraordinary repeat session on the matter. In November, Dr. Osnat Luxemburg, head of the Health Ministry's Medical Technologies and Infrastructures Authority, wrote Yahalom to report that the committee had discussed the subject and repeated its previous decision not to add Gliadel to the health basket.

'A lot of political pressure'

A rare glimpse at the operation of Trading Pharma, the company that markets Temodal in Israel and whose sales might have suffered had Gliadel been added to the basket, is provided through examination of a confidential internal company memo. The memo in question was emailed on July 31, 2003 to company employees by Dr. Robert Winkler, the company's medical and scientific affairs director. Winkler wrote that "Professor Avi Israeli spoke with Tali Siegal and told her that a lot of political pressure is placed on him in order to approve Gliadel as an alternative with no added cost to sal briut [health basket - R.R.]. Tali discussed with Doron [Trading Pharma CEO Doron Schwartz - R.R.] and with me, and apparently she may be consulted by Avi ahead of him making the final second recommendation for Gliadel."

Winkler noted, "The risk is that if Gliadel is approved in the sal - this will cut drastically the use of Temodal (in brain cancer) casue [sic] the Gliadel may be used instead for 3 months." This statement significantly reinforces the neurosurgeons' claim that Gliadel is an alternative to Temodal and can be added to the health basket without any additions to the budget, as opposed to what the committee stated in its decision.

Winkler also assigned the employees a list of tasks to carry out prior to the drafting of a position letter, "that will oppose the claims raised in the Knesset committee." Among other assignments, he asked to acquire letters from neuro-oncologists "that Gliadel is not an alternative to Temodal." He also asked that someone look into a claim that the father of one of the senior physicians that favors Gliadel has interests in the firm that manufactures it, as well as the "very vague claim" that there is a connection between a party associated with the Israeli distributor of Gliadel and the National Religious Party, MK Yahalom's party.

In an email dispatched the following day by Trading Pharma CEO Schwartz, the employees are asked "to maintain full discretion in all aspects related to this subject. Due to the sensitivity of the subject, I request that you not share [what you know] with anyone beyond those on the distribution list."

In answer to questions posed by Haaretz regarding the internal memo, Winkler replied that Temodal, "the drug of choice for treatment of the most severe types of cancer," has proved its great effectiveness in extending life, and in certain cases, even saving life. He also said, "We feel that it is our commercial and public duty to bring the relevant information about Temodal to the attention of all of the bodies responsible for health budgets in Israel." Siegal stated that she had submitted to the Health Ministry a document detailing the accepted treatments for brain tumors, including the use of Gliadel and Temodal, and that beyond that, she had nothing else to say.

The Health Ministry stated that the basket committee "performs its work in a professional manner, and is not influenced by commercial opinions or considerations." Regarding Gliadel, the ministry stated that "Drugs and medical technologies for which it has been proven that their addition to the basket would not cause any added cost are added to the basket every year, but this was not the case for Gliadel, the addition of which would involve added cost." Furthermore, "In accordance with the new procedures in the committee, all of the experts that appeared before it were asked to sign a form in which they were asked to declare and detail any connection they might have with a commercial firm related to a drug or its competitors. Among the experts who submitted their professional opinions were Professor Ram and Professor Siegal."

Regarding Temodal, the Health Ministry said "the preparation is registered in Israel and is approved for use, having been found effective for the indication for which it was registered, and was added to the basket in 2001 after having been found appropriate for this use."

Nevertheless, in contradiction to the ministry's response, Israeli told the Knesset's Labor, Welfare and Work Committee at its July 12, 2003 session: "Temodal is not a success story, either." At the same meeting, MK Nissim Dahan, the former health minister, said that the addition of Gliadel to the basket would lead to a financial savings and that he always thought "Gliadel had to be added - but that the doctors had been arguing over it for four years - and the public was suffering."




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