New FDA Acting Commissioner
Acting FDA Chief Asserts a Need
To Review Drug-Approval Process
By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
September 26, 2005
Andrew von Eschenbach, the new acting head of the Food and Drug Administration, said he would like to examine whether the drug-review process needs changes to "streamline and accelerate" the approval of promising new therapies.
Dr. von Eschenbach, who will continue in his current position as director of the National Cancer Institute, said it is too soon to consider whether he will be nominated to serve as the FDA's permanent commissioner. He said that he believes he can bring a "full commitment" to the leadership of both agencies, and he remains "totally, completely and absolutely dedicated" to his role at the cancer institute, which is part of the National Institutes of Health.
Dr. von Eschenbach was named as the acting commissioner Friday, after the resignation of Lester Crawford, who had been confirmed to the FDA leadership position just two months ago. Dr. Crawford, age 67, gave no reason for the unexpected decision, but people with knowledge of the matter have said it was connected to concerns about a financial interest that may not have been disclosed. The FDA has declined to comment on the cause. (See related article1).
Dr. von Eschenbach, a cancer survivor and oncologist with close relationships with patient groups, is identified with a high-profile goal of eliminating suffering and death due to cancer by 2015. He said the FDA's drug-review process is the "gold standard," but "no matter how good it is, the question always has to be asked, can we make it better?" He "sees the need to consider" changes designed to streamline the process for important new treatments, "within the context of continuing to assure their efficacy and safety." But "speed does not mean recklessness," he said.
Overall, Dr. von Eschenbach said, he has no plans to sharply change the direction of the FDA and hopes to bring stability by relying on experienced staff and continuing initiatives begun under Dr. Crawford and his predecessor, Mark McClellan. Those include efforts to bridge gaps between drug regulation and cutting-edge science -- including deepened ties to the cancer institute -- and to make emerging safety information available to patients. "I absolutely believe in openness and being transparent, and being clear," he said.
He said he isn't yet in a position to comment about Plan B, the emergency contraceptive that its manufacturer wants to sell without a prescription. Dr. Crawford's delay of a final decision on the switch drew criticism and the resignation of an FDA official who argued that the agency's scientists had been overruled. "Decisions have to be guided by science," he said, but when the "science is incomplete, we have to err on the side of safety" and, in the words of the physicians' oath, "do no harm."
In speaking about easing barriers to the approval of drugs, Dr. von Eschenbach would be moving in a direction that hasn't been a major public emphasis for the FDA recently. After the withdrawal last year of the painkiller Vioxx, the agency has come under pressure to increase the weight it places on safety in reviewing drugs. Some industry officials have said they believe there is a cautious attitude at the agency in the wake of questioning from Congress. The FDA has said that drug-approval times haven't changed.
New FDA Chief Wants to Transform Treatment
Sunday September 25
By John J. Lumpkin, Associated Press Writer
New FDA Chief Wants to Foster Transformation in Doctor's Ability to Treat Patients
WASHINGTON (AP) -- The new acting chief of the Food and Drug Administration says he will be presiding over a transformation in medicine as scientists come to understand diseases in a more detailed way that could improve doctors' ability to treat patients.
Dr. Andrew C. von Eschenbach, tapped by President Bush as the temporary chief of the regulatory agency, said Sunday that discoveries about diseases at "a molecular level" will lead to a new kind of health care.
Now, doctors treat illnesses based on how well other people have responded to a given treatment. Soon, they will develop a tailored response built around specific understandings of the patient, the treatment and the disease, he said.
"We are discovering so much about diseases like cancer at the molecular level," said von Eschenbach, a urologic surgeon by training. "Much of what we have done ... has been based on a model of empiricism." Soon, doctors will be able to intervene with medical treatments more effectively matched to a specific patient's illness.
Preparing the FDA for this transformation is among his goals, von Eschenbach said.
Von Eschenbach said he will remain chief of the National Cancer Institute, the government's lead agency in researching cancer treatments, while running the FDA. He gave no indication of whether he expected to be nominated as permanent chief of the FDA.
He replaces Commissioner Lester Crawford, out only two months after the Senate confirmed him for the post. Crawford had functioned as acting head for more than year.
Crawford's surprise resignation, submitted Friday and effective immediately, gave no specific reason for his departure. His tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics or benefiting drug companies than in its mission to protect consumers.
Von Eschenbach declined to discuss in detail specific cases that have led to criticism of the FDA, including those of Vioxx, one class of painkiller only lately tied to heart problems, and Plan B, an emergency, morning-after contraceptive that the FDA has yet to approve for over-the-counter sales despite assurances that it is safe.
Despite the criticism, von Eschenbach had only praise for his colleagues at the FDA, calling the agency the "gold standard" for food and health care regulation.
"I have an enormous amount of respect, admiration and appreciation for them," he said, adding he will continue many of the initiatives of his predecessors while looking for ways to improve agency operations.
The new FDA chief has a reputation for optimism. His stated goal of eliminating suffering and death due to cancer, turning it into a manageable disease, by 2015 is regarded as ambitious by some and unlikely by others.
He has seen cancer from both sides, having survived three diagnoses: melanoma, prostate cancer and basal cell carcinoma.
Von Eschenbach also discussed the perpetual challenge for the agency: speeding new treatments to the market while ensuring they are safe. Sometimes those values are in conflict, as pressure from drug companies and patients to make new treatments available run up against incomplete or ambiguous safety data.
"I believe very strongly that science has to drive and is the driver of our knowledge and our understanding, and therefore of our decisions," he said. "Where science is incomplete, we continue to believe that under any circumstances, do no harm."
But with new treatments, von Eschenbach said: "I believe it's still important to ask the question, "How can we accelerate the timeline? How can we make certain we are getting these interventions to the patients as quickly as possible?"
The Philadelphia native served as chief academic officer of the University of Texas M.D. Anderson Cancer Center in Houston prior to taking over the National Cancer Institute in 2002.
More on New FDA Head
The Crawford Resignation Mystery
GoozNews by Merrill Goozner
September 24, 2005
True to form, the administration picked late Friday afternoon to announce that Food and Drug Administration commissioner Lester Crawford resigned. The veterinarian in charge of the world's premier food and drug safety agency, who was confirmed for the job just two-and-a-half months ago, cited his age. He is 67.
The Saturday morning papers (the least read of the week; that's why troubling announcements get released late Friday) gave no clues as to what drove the decision, although both the New York Times and the Washington Post hinted broadly that he was forced out. But why? It couldn't have been the postponement -- again -- of approving Plan B, the morning after contraceptive pill. Crawford was doing the administration's bidding on that issue.
One possible clue to the administration's thinking comes from the appointment of Andrew von Eschenbach, head of the National Cancer Institute, as acting commissioner. Von Eschenbach, who previously ran the M.D. Anderson Cancer Center at the University of Texas, has been touting the new generation of targeted cancer drugs and in recent speeches has been confidently predicting that cancer would become a manageable disease -- like AIDS -- by 2015.
The Post story mentions that many oncologists have criticized von Eschenbach for overpromising, but ignores the back story. His prediction and embrace of the latest drugs has been prominently featured by the conservative Manhattan Institute, whose work on FDA and medical issues is conducted at its Center for Medical Progress. The Center is funded by the drug industry.
In the world of journalism, the Wall Street Journal's editorial page has been touting the new cancer therapies even when the clinical trial evidence shows they don't work or help as few as 10 percent of patients (and even then only for a few months). The Journal has been on the warpath against Richard Pazdur, who runs the FDA's oncology bureau, claiming he has slowed the pace of drug approvals.
Paul Goldberg's influential "Cancer Letter" pointed out in its August issue how a right wing "insurgency" is pushing for early approvals of cancer drugs. The insurgency includes Michael Milken (who has been treated for prostate cancer) and an all-star cast of conservative think tanks like the Manhattan Institute, the American Enterprise Institute, the Cato Institute, the Competitive Enterprise Institute, the Washington Legal Foundation and a cancer patient advocacy group known as the Abigail Alliance.
Grabbing a page from the AIDS activists of the early 1990s, their slogan is early access to experimental cancer drugs for the dying. If they can get the FDA to approve early access based on experimental data that suggests a new, experimental drug may affect the disease (usually based on some surrogate marker like tumor shrinkage, which can have no relationship to survival), they can then force insurance companies, Medicare and Medicaid to pay for the treatments.
That would be a godsend to the drug industry, which has invested billions in searching out cancer cures with marginal success. The new targeted therapies can cost anywhere from $4,000 to $10,000 a month. No wonder it has financially supported many of the conservative groups in the coalition.
Pazdur, who also came to the FDA from the M.D. Anderson Cancer Center, has fought to hold the line for the agency's traditional standard that a drug be shown to be effective before getting approved. His staff has also done a good job assessing whether a new drug's usually marginal benefits outweigh the substantial side effects and risks that are often associated with cancer therapies, including the newer targeted therapies. Just yesterday Genentech announced it had to stop a trial of its new drug Avastin for ovarian cancer after 11 percent of patients began developing holes in their stomachs and intestines.
There is a serious discussion that needs to take place at the FDA about how companies with new therapies can be encouraged to collaborate to see if in combination these drugs can have a major impact on cancer. But sophisticated scientific discussions and breaking the entrenched habits of competitive drug firms is not what the ideologues behind the anti-Pazdur campaign have in mind.
If von Eschenbach forces his former colleague out and appoint someone more malleable to run the agency's oncology division, we'll know the real reason why Crawford resigned.