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U.S. White House Announces Initiatives to Speed FDA Cancer Drug Approvals |
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 Top U.S. White House Announces... National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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In the most significant of the four initiatives announced at the White House March 29, Administration officials said FDA would accept data on partial responses as evidence of the efficacy of new cancer drugs. In recent years, FDA demanded that sponsors demonstrate a drug extends survival, produces complete responses or enhances the quality of life. However, according to several observers, the agency has been inconsistent in judging the significance of partial responses.
In other initiatives, FDA said it would expand patient access to drugs approved in other countries, include cancer patients on FDA advisory committees, and inform investigators that they do not need to file Investigational New Drug applications to conduct certain types of studies of approved drugs.
The changes do not address two issues viewed as central by oncologists and many patient groups: accelerating the approval process for Supplemental New Drug Applications (SNDA) and allowing drug companies to distribute peer-reviewed materials on off-label uses of cancer drugs.
"These steps will speed cancer drugs to patients who need them, when they need them," President Bill Clinton said as he announced the initiatives. "They will help save lives. They will do this by cutting red tape."
Vice President Al Gore said the policy changes were part of the Administration’s "reinventing government" effort begun three years ago. "One by one, agencies are restoring common sense to regulation," Gore said. "It is because President Clinton instructed people working for him to make government work better and cost less and be more efficient, get rid of the nonsense and replace it with common sense."
Oncology professional societies and cancer patient advocates welcomed the initiatives, but urged the Administration to support legislative reform of FDA.
"While we applaud the Administration for proposing new anticancer initiatives, these initial steps must be accompanied by reasonable and sound legislative reform of the FDA," said John Glick, President of the American Society of Clinical Oncology.
Just the day before the White House announcement, the Senate Labor and Human Resources Committee passed the FDA reform legislation introduced by Senator Nancy Kassebaum (R-KS). The Administration opposes the legislation.
The committee approved the bill on a 12 to 4 vote. The bill sets rigid deadlines for FDA action on applications and requires FDA to establish a process for approval of SNDAs. However, the bill no longer contains a provision on distribution of information on off-label indications for cancer drugs.
The sponsors of the provisions, Senators Connie Mack (R-FL) and Bill Frist (R-TN), are expected to reintroduce the measure on the Senate floor, sources said. 
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National Cancer Institute, Under New Director, Conducts Major Restructure of Programs, Budget |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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Under a new director, microbiologist Richard Klausner, installed by President Clinton last August, NCI is conducting detailed reviews of every program and budget in the $2 billion a year agency of the U.S. Dept. of Health and Human Services.
One of the first items on Klausner’s agenda was a massive restructure of the Institute’s divisions which contained both intramural research groups as well as programs that administered extramural research. Critics said this organization tended to enhance intramural research at the expense of funding for research grants at universities and cancer centers.
With the retirement of two division directors prior to his appointment, Klausner encountered almost no internal opposition to the reorganization. The reorganization separated the intramural research from extramural research administration.
The next step in the reorganization is a detailed review of the Institute’s fiscal expenditures and a new policy designed to give intramural scientists more autonomy over their budgets, Klausner said.
Sources said Klausner is likely to increase funds for investigator-initiated research at the expense of funding for contracts and intramural research.
The reorganization is expected to include the following:
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Intramural PIs to Control Own Budgets, Have Greater Autonomy |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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Under a plan presented to the National Cancer Advisory Board by NCI Director Richard Klausner, all principal investigators would be able to control the budgets of their research projects.
Currently, in most NCI laboratories, the budgets of all research projects—and therefore the direction of research—are controlled by lab chiefs.
"In some cases, lab chiefs simply did not inform PIs about the sizes of their budgets," Klausner said. The confusion was compounded by the lack of uniform accounting methods at the Institute.
"In exchange for greater autonomy, principal investigators will be subject to a more rigorous review process. The proposed system will resemble more closely university laboratories," NCI officials said.
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Tamoxifen Use Limit 5 Years, NCI Recommends in Letter |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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The recommendation, contained in a letter mailed to 22,000 oncologists in the U.S., follows a decision by the National Surgical Adjuvant Breast and Bowel Project to stop a trial of tamoxifen as an adjuvant therapy for breast cancer.
The trial, protocol B-14, which compared five years to 10 years of tamoxifen (Nolvadex®) after surgery in women with node-negative, estrogen receptor-positive breast cancer, found no additional benefit for women taking the antiestrogen for more than five years.
The incidence of second primary tumors in the two groups was slightly higher in the 10-year group, but the difference was not statistically significant, NCI and NSABP officials said.
"There was a time when many people believed that tamoxifen should be given for the life of the patient, because it was thought to be a cytostatic agent, and, obviously, the information from the NSABP protocol B-14 refutes that belief," said Norman Wolmark, chairman of NSABP.
"Whatever effect is going to be achieved is achieved with five years of treatment, and that positive effect could last a lifetime," Wolmark said to The Cancer Letter.
The B-14 trial was halted after the study’s Data and Safety Monitoring Committee found that the results indicated the lack of additional benefit for tamoxifen beyond five years.
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NEJM Papers Reaffirm Results of NSABP Lumpectomy Trial |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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One of the papers, submitted by the National Surgical Adjuvant Breast and Bowel Project, found that the results of the lumpectomy study, protocol B-06, were not affected by fraudulent data submitted by St. Luc Hospital in Montreal.
Another paper, an overview of an NCI audit of NSABP data, said the NSABP data were accurate and apparently not marred by any additional incidents of fraud. Altogether, NCI auditors were able to verify 97.5% of the 7770 data points that were audited.
Bernard Fisher, who was toppled from his post as chairman of the cooperative group in the midst of controversy over the reliability of the data and the adequacy of NSABP auditing procedures, said the NEJM publications demonstrate that last year’s events amounted to a "tempest in a teapot."
"These publications should remove any questions or doubts from the minds of the patients and physicians about the validity of the B-06 study," Fisher, the lead author on the NSABP paper who serves as the cooperative group’s scientific director, said.
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Michael Milken Calls for Renewed War on Cancer, $20 Billion Effort |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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At a Washington conference last November, called the National Cancer Summit, Milken presented the synthesis of his findings and revealed what may be the most ambitious cancer research agenda ever.
While in recent years NCI officials have shied away from bold military allusions, all but dropping the rhetoric of "The War On Cancer," Milken returned to the war path, calling for a new $20 billion-a-year worldwide assault on the disease.
"The money could come from the U.S. government, industry, charitable foundations and other nations," Milken said. "In a nutshell," Milken argued, "the War on Cancer has not been given the same commitment, energy and investment as defense and information technology, and, for that reason it has not yielded comparable returns of wealth and glory. Make cancer a priority, adapt research to the age of information, streamline the unwieldy regulatory mechanisms, and dazzling returns will surely follow."
The astronomical figure proposed by Milken did not seem to raise any eyebrows among the over 200 prominent cancer researchers, clinicians and patient advocates who attended the summit.
"It’s not very difficult to spend $20 billion," Vincent DeVita, former NCI Director who heads the Yale Cancer Center, said. "Right now you have a starving enterprise at about $2.2 billion. We are funding 15% of approved applications, if we are lucky. You could go up to $4 billion by blinking an eye, without breaking into a sweat."
Numbers notwithstanding, DeVita and other supporters said Milken’s emergence as a cancer advocate may give the cancer program something it hasn’t had in over a decade: a bold vision and strong advocacy.
If anything, the summit served as something of an unveiling for Milken, an opportunity to acquaint the powers in cancer research with the results of his three-year quest.
"Clearly, we have not mobilized all possible resources to win the war on cancer," Milken said at the summit. "Cancer is not just an American problem; it is a worldwide problem. Financial and human capital from around the world needs to be mobilized."
The U.S. can no longer support cancer research without the involvement of other countries, Milken said.
"Cancer patients from around the world travel to the U.S. for its superior research and treatment," Milken said. "Nevertheless, our medical research infrastructure is now in danger of weakening from the weight of neglect and lack of sufficient funding. Recent reductions by both the public and private sectors make it all but impossible to sustain even current research efforts."
The 1991 Persian Gulf War provides a model of a successful international mobilization, Milken said. "What is required are seven critical elements: leadership, communications, collaboration, technology, financial resources, human capital, and most of all, the will to win," he said. "The most recent example of such a convergence came during the Gulf War."
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Pharmacia & Upjohn Merger Complete, Sales Nearly $7 Billion |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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The new company, Pharmacia & Upjohn Inc., is chartered in Delaware and would have had combined sales of nearly $7 billion in 1994. With the merger, the company will have 34,200 employees and a research and development budget of $1.1 billion.
To proceed with the merger, the two companies agreed to license out a cancer drug under development by Pharmacia. The licensing was demanded by the Bureau of Competition of the Federal Trade Commission, which noted that Upjohn and Pharmacia were developing analogous topoisomerase I inhibitors.
Pharmacia & Upjohn agreed to spin off 9-AC 9-Amino-20(S)-camptothecin, a Pharmacia drug. The new company will retain the rights to CPT-11, originally an Upjohn product.
The new firm’s corporate management center will be located in London and will open in temporary quarters in December. The company’s stock is traded on the New York Stock Exchange under the symbol PNU.
Jan Ekberg, former president and CEO of Pharmacia AB, is the new chairman of Pharmacia & Upjohn Inc. John Zabriskie, former chairman and CEO of the Upjohn Co., is the new company’s first president and CEO.
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Americans Get Access to Vital New Drugs Faster, FDA Report Says, |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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The study found that Americans had access to almost every vital drug sold in those countries.
Americans got five AIDS drugs before any other country, the ovarian cancer drug Taxol® a year earlier than Europeans, the first multiple sclerosis drug 28 months before Europe and the first cystic fibrosis treatment several months before Europe, the report said.
"If there is a drug lag, it is not in America," said Commissioner David Kessler.
The FDA also issued its annual report to Congress showing that in fiscal 1994 the agency approved 93 percent of all drugs within a year of the companies’ applications. Federal law mandates that the FDA approve 55 percent of drugs in that time.
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FOOTNOTES |
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TopU.S. White House Announces...National Cancer Institute, Under...Intramural PIs to Control...Tamoxifen Use Limit 5...NEJM Papers Reaffirm Results...Michael Milken Calls for...Pharmacia & Upjohn Merger...Americans Get Access to... |
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