Lilla Romeo, Pt Advocate Quoted on Limits to Anemia Drugs
F.D.A. Panel Seeks Limits on Cancer Patient Drugs
By ANDREW POLLACK
SILVER SPRING, Md., May 10 Bowing to safety concerns, government medical advisers urged on Thursday that additional restrictions be put on the use of drugs that treat anemia in cancer patients.
The recommendations by an advisory committee to the Food and Drug Administration followed a flurry of studies suggesting that the drugs, meant to help patients cope with chemotherapy, might actually be making their cancer worse or hastening their deaths.
The drugs Aranesp from Amgen and Procrit from Johnson & Johnson are used by about a half-million American cancer patients a year and have billions of dollars in annual sales.
Some members of the committee expressed shock that even though Procrit was first approved 14 years ago, it was still not clear if the drugs were safe at the doses typically used.
“Yes, we have a burning question,” one panel member, Dr. Silvana Martino, an oncologist in Santa Monica, Calif., said at the meeting here. “Do these things kill people?”
Most of the studies showing a risk involved use of the drugs at doses higher than doctors typically give them. That left the committee with the question of what to do about use of the drugs at the usual doses until more data become available.
The F.D.A. has already clamped down on the drugs. In March it put strict new warnings on the labels, saying the products should be used at the smallest dosage that lets anemic patients avoid blood transfusions.
But the panel’s votes Thursday portend even further restrictions. The committee voted 12 to 5, for instance, that the drugs should be barred from use by patients with certain types of cancer until more is known about their safety. While the committee did not specify which types, several members mentioned breast cancer, non-small cell lung cancer and head and neck cancer.
The committee voted 15 to 2 that there should be more restrictions in general if the drugs remain on the market, and 17 to 0 that more studies were needed. And it voted 16 to 1 that anemia therapy should be stopped when chemotherapy is finished.
But in one victory for the drug makers, the committee voted 11 to 6 against lowering the ceiling on how much the anemia should be corrected. The labels now say that a patient’s hemoglobin, the oxygen-carrying component of red blood cells, should not be raised to more than 12 grams per deciliter of blood.
The F.D.A. usually follows the recommendations of such panels. Dr. Richard Pazdur, director of the agency’s cancer drug division, said Thursday he could not say yet when or how the agency would act.
The two drugs, along with another Amgen drug, Epogen, are also used to treat anemia caused by kidney disease, but yesterday’s meeting concerned only cancer treatment. Another hearing dealing with kidney disease will be held early in the fall.
The panel’s recommendations were a particular blow to Amgen, which last year took in nearly half its $14.3 billion in revenue from the anemia drugs. Johnson & Johnson is far larger and more diversified than Amgen, and so is less dependent on Procrit sales.
“I think it’s worse than what investors expected,” Michael Aberman, an analyst who follows Amgen for Credit Suisse, said after the meeting. Amgen’s stock fell $5.77, or more than 9 percent, to close at $57.33.
Trish Hawkins, an Amgen spokeswoman, said in a statement, “We will be working with the F.D.A. as they consider the committee’s recommendations.”
The drugs, known generically as darbepoetin and epoetin, were approved to reduce the need for blood transfusions in patients with anemia from chemotherapy. Many doctors and patients believe the drugs fight fatigue and improve patients’ daily lives, although the F.D.A. said it did not find studies with persuasive evidence of such benefits.
A panel member from Emory University, Dr. Otis Brawley, said some doctors overprescribed the drugs because they made money from doing so. Doctors can sometimes receive more from insurers than they pay for the drugs, especially if they receive rebates from the manufacturers.
Dr. Brawley said the drug companies had not done proper studies, and at one point asked them, “What data do you have to assure me that this is not Miracle-Gro for cancer?”
The staff of the F.D.A. was also critical of the companies, saying they had not provided data they had promised when a similar advisory panel meeting was held in 2004.
The companies and their advocates argued that ample data showed the drugs were safe when used properly, except for a long-known risk of increased blood clots.
They also argued that the drugs had significant benefits. Forcing cancer patients to go back to transfusions, they said, would expose the patients to risks and inconvenience and further strain the nation’s already taxed blood supply.
That sentiment was also voiced by some committee members. “I think the idea of going back to the dark ages in regards to supportive care is a step backward,” said Dr. S. Gail Eckhardt of the University of Colorado, the panel’s chairman.
Advisory panel meetings often feature eloquent pleas from patients that a drug be approved or kept on the market. But there was not a big outpouring of support for the anemia drugs. In fact, some patients expressed dismay at how the drugs were used.
“How is it possible that what was meant to help me might actually have made things worse?” said Lilla Romeo, who has had breast cancer since 1995.
The New York Times
May 11, 2007
By ANDREW POLLACK
SILVER SPRING, Md., May 10 Bowing to safety concerns, government medical advisers urged on Thursday that additional restrictions be put on the use of drugs that treat anemia in cancer patients.
The recommendations by an advisory committee to the Food and Drug Administration followed a flurry of studies suggesting that the drugs, meant to help patients cope with chemotherapy, might actually be making their cancer worse or hastening their deaths.
The drugs Aranesp from Amgen and Procrit from Johnson & Johnson are used by about a half-million American cancer patients a year and have billions of dollars in annual sales.
Some members of the committee expressed shock that even though Procrit was first approved 14 years ago, it was still not clear if the drugs were safe at the doses typically used.
“Yes, we have a burning question,” one panel member, Dr. Silvana Martino, an oncologist in Santa Monica, Calif., said at the meeting here. “Do these things kill people?”
Most of the studies showing a risk involved use of the drugs at doses higher than doctors typically give them. That left the committee with the question of what to do about use of the drugs at the usual doses until more data become available.
The F.D.A. has already clamped down on the drugs. In March it put strict new warnings on the labels, saying the products should be used at the smallest dosage that lets anemic patients avoid blood transfusions.
But the panel’s votes Thursday portend even further restrictions. The committee voted 12 to 5, for instance, that the drugs should be barred from use by patients with certain types of cancer until more is known about their safety. While the committee did not specify which types, several members mentioned breast cancer, non-small cell lung cancer and head and neck cancer.
The committee voted 15 to 2 that there should be more restrictions in general if the drugs remain on the market, and 17 to 0 that more studies were needed. And it voted 16 to 1 that anemia therapy should be stopped when chemotherapy is finished.
But in one victory for the drug makers, the committee voted 11 to 6 against lowering the ceiling on how much the anemia should be corrected. The labels now say that a patient’s hemoglobin, the oxygen-carrying component of red blood cells, should not be raised to more than 12 grams per deciliter of blood.
The F.D.A. usually follows the recommendations of such panels. Dr. Richard Pazdur, director of the agency’s cancer drug division, said Thursday he could not say yet when or how the agency would act.
The two drugs, along with another Amgen drug, Epogen, are also used to treat anemia caused by kidney disease, but yesterday’s meeting concerned only cancer treatment. Another hearing dealing with kidney disease will be held early in the fall.
The panel’s recommendations were a particular blow to Amgen, which last year took in nearly half its $14.3 billion in revenue from the anemia drugs. Johnson & Johnson is far larger and more diversified than Amgen, and so is less dependent on Procrit sales.
“I think it’s worse than what investors expected,” Michael Aberman, an analyst who follows Amgen for Credit Suisse, said after the meeting. Amgen’s stock fell $5.77, or more than 9 percent, to close at $57.33.
Trish Hawkins, an Amgen spokeswoman, said in a statement, “We will be working with the F.D.A. as they consider the committee’s recommendations.”
The drugs, known generically as darbepoetin and epoetin, were approved to reduce the need for blood transfusions in patients with anemia from chemotherapy. Many doctors and patients believe the drugs fight fatigue and improve patients’ daily lives, although the F.D.A. said it did not find studies with persuasive evidence of such benefits.
A panel member from Emory University, Dr. Otis Brawley, said some doctors overprescribed the drugs because they made money from doing so. Doctors can sometimes receive more from insurers than they pay for the drugs, especially if they receive rebates from the manufacturers.
Dr. Brawley said the drug companies had not done proper studies, and at one point asked them, “What data do you have to assure me that this is not Miracle-Gro for cancer?”
The staff of the F.D.A. was also critical of the companies, saying they had not provided data they had promised when a similar advisory panel meeting was held in 2004.
The companies and their advocates argued that ample data showed the drugs were safe when used properly, except for a long-known risk of increased blood clots.
They also argued that the drugs had significant benefits. Forcing cancer patients to go back to transfusions, they said, would expose the patients to risks and inconvenience and further strain the nation’s already taxed blood supply.
That sentiment was also voiced by some committee members. “I think the idea of going back to the dark ages in regards to supportive care is a step backward,” said Dr. S. Gail Eckhardt of the University of Colorado, the panel’s chairman.
Advisory panel meetings often feature eloquent pleas from patients that a drug be approved or kept on the market. But there was not a big outpouring of support for the anemia drugs. In fact, some patients expressed dismay at how the drugs were used.
“How is it possible that what was meant to help me might actually have made things worse?” said Lilla Romeo, who has had breast cancer since 1995.
The New York Times
May 11, 2007
Lilla Romeo, Breast Cancer Advocate, NYC
It is with deep sadness that we write to tell you about the death of our beloved Lilla.
She passed peacefully, surrounded by her family, this afternoon, Wednesday, June 9th.
As most of you know, Lilla had been fighting metastatic breast cancer for ten years. She underwent almost continuous treatment over that time, but refused to let the disease define or confine her.
She lived actively and positively, giving us all the pleasure of enjoying her company in so many ways over the years. All of you know how energetically she chose to live her life.
Lilla’s experience with breast cancer did stimulate her both to help others with the disease and to work for its eradication. She studied the disease and its treatment and, through her passion, intellect and force of personality, became a highly respected, sought after and influential patient advocate.
But for us, her husband and children, she will be remembered most as a loving wife, mother, and Nana to seven beautiful grandchildren.
Ann’s NOTE: Lilla spoke at the May 22-25, 2010 National Breast Cancer Coalition Fund’s annual advocacy conference. Her death took place on June 9. She worked to help others almost up until that time! She was an amazing woman.
It is with deep sadness that we write to tell you about the death of our beloved Lilla.
She passed peacefully, surrounded by her family, this afternoon, Wednesday, June 9th.
As most of you know, Lilla had been fighting metastatic breast cancer for ten years. She underwent almost continuous treatment over that time, but refused to let the disease define or confine her.
She lived actively and positively, giving us all the pleasure of enjoying her company in so many ways over the years. All of you know how energetically she chose to live her life.
Lilla’s experience with breast cancer did stimulate her both to help others with the disease and to work for its eradication. She studied the disease and its treatment and, through her passion, intellect and force of personality, became a highly respected, sought after and influential patient advocate.
But for us, her husband and children, she will be remembered most as a loving wife, mother, and Nana to seven beautiful grandchildren.
Ann’s NOTE: Lilla spoke at the May 22-25, 2010 National Breast Cancer Coalition Fund’s annual advocacy conference. Her death took place on June 9. She worked to help others almost up until that time! She was an amazing woman.
