Thursday, February 19, 2009

FDA requires Patients to Die for "Pretty Numbers" in Rituxan study

The following article is primarily about the fact that giving Rituxan more than one time for patients with B cell cancers prolongs their lives but hidden in the middle of it is a couple of lines about clinical trials required by the Mengeles at the FDA that required patients to die in order for the FDA to accept the findings of a clinical trial.

Patients were divided into three groups chemotherapy only, Rituxan only, and Rituxan plus chemotherapy. One of those groups was a DEATH CAMP group. Can you tell which one?

It was the chemotherapy alone. Clinical trials with those chemotherapy agents were done YEARS AGO. The results are in and known. There is no reason to redo those trials. The patients live a little longer than no treatment but they die and they die on average in a certain number of months that WAS ALREADY KNOWN. It was determined in clinical trials YEARS AGO.

The FDA required patients with fatal B cell cancer whose average number of months of remaining life was already known to take those less than ideal chemotherapy drugs alone and to die so FDA bureaucrats could have pretty numbers. PLACEBO GROUPS ARE DEATH CAMP GROUPS. The FDA bureaucrats who require these pretty numbers are MURDERERS.

Do you suppose the people who died for the FDA to have pretty numbers had families and friends who were devastated? Well what does it matter, requiring redundant trials to find the same thing again and again is what the FDA bureaucrats are good at. The most awful part is the bureaucrats who require patients to die always get promoted and never get demoted or fired. It is time to change the culture of death at the FDA.

Read the article below:

Rituximab Should Be Used for Maintenance in Follicular Lymphoma

Zosia Chustecka
Medscape Medical News 2009. © 2009 Medscape
February 18, 2009 — Rituximab should be used for maintenance therapy in patients with relapsed or refractory follicular lymphoma after successful induction therapy because it significantly improves survival.

This is the conclusion from a new meta-analysis of 5 trials, involving more than 1000 patients, published in the February 18 issue of the Journal of the National Cancer Institute.
"This meta-analysis demonstrates for the first time, to our knowledge, that rituximab maintenance therapy improves overall survival and disease control," say the researchers, headed by Liat Vidal, MD, from the Rabin Medical Center, in Petah-Tikva, Israel.

"Rituximab should be used for patients with relapsed follicular lymphoma after successful induction treatment," Dr. Vidal told Medscape Oncology. Such use is not currently recommended in guidelines, but many physicians are already doing this, he said.

Already Established in First-Line Treatment

Rituximab is already established in the first-line treatment of follicular lymphoma, for which it is often used in combination with chemotherapy. As reported by Medscape Oncology, a recent editorial in the Journal of Clinical Oncology (2008;26:4537-4538) said it was "time to declare a giant leap forward," because patients with follicular lymphoma are now living longer than ever and rituximab has been a major contributor to the progress that has been made in the treatment of this disease.

However, the question of what to do when a patient relapses or becomes refractory has not had a clear answer. Dr. Vidal and colleagues point out that individual trials exploring rituximab use in this situation have shown a prolongation of remission and of the progression-free interval, but have not yielded any clear evidence of an impact on overall survival. As a result, rituximab maintenance for follicular lymphoma is not recommended in treatment guidelines, such as those issued by the National Comprehensive Cancer Network, they point out.

Now, however, Dr. Vidal and colleagues have shown a clear survival advantage from the meta-analysis of 5 trials that they performed. The trials involved 1143 patients, but survival data were available for only 985 patients.

Patients who received rituximab maintenance had significantly better overall survival that those who did not (hazard ratio [HR] for death, 0.60; 95% confidence interval [CI], 0.45–0.79).
However, patients taking rituximab were twice as likely to have an infection-related adverse effect (HR, 1.99; 95% CI, 1.21–3.27), and some of the infections reported in these patients were life-threatening, Dr. Vidal and colleagues report. "The higher rate of infections should be taken into consideration when making treatment decisions," they say.

Survival Advantage Seen With Both Schedules

The 5 trials in the meta-analysis used various drug combinations and administration schedules, but the type of rituximab maintenance schedule had no effect on overall survival, the researchers note.

At the time when the clinical trials were initiated, rituximab was not yet established as a standard in first-line treatment, so some patients received it in their induction regimen and others did not. Some patients were treated with first-line rituximab alone, some with rituximab and chemotherapy, and some with chemotherapy alone. (these patients died months earlier than the other two arms of the clinical trial)

In addition, the maintenance regimens varied. In 3 trials, rituximab was administered weekly for 4 consecutive weeks (4 doses) every 6 months, whereas in the 2 other trials, a single infusion of rituximab was administered every 2 to 3 months. The duration of treatment varied from 8 to 9 months to 2 years.

"Our results suggest that rituximab maintenance therapy for up to 2 years, either as 4 weekly infusions every 6 months or as a single infusion every 2 to 3 months, should be added to standard therapy of patients with relapsed or refractory follicular lymphoma after successful induction treatment," Dr. Vidal and colleagues conclude.

This study was performed as part of, and with the support of, the Cochrane Hematological Malignancies Group of the Cochrane Collaboration. Dr. Vidal disclosed no relevant financial relationships. Two of his coauthors, Martin Dreyling, MD, from the Univeritat Munchen-Grobhadern, in Germany, and Michele Ghielmini, MD, from the Swiss Group for Clinical Cancer Research, in Bern, Switzerland, report receiving research funding and either consultancy fees or speaker honorarium from Roche, the manufacturer of rituximab.
J Natl Cancer Inst. 2009:101:248-255.

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