POLICY: On von Eschenbach’s appointment, by Gregory Pawelski

Greg Pawelski with a view on the new head of the FDA

More and more physicians and patients are turning to individualized therapies to treat cancers. Under this approach, scientists study how an individual’s cancerous cells respond to several drugs. Doctors have learned that even when the disease is the same type, different patients’ tumors respond differently to chemotherapeutic drugs. Treatments need to be individualized based on the unique set of molecular targets produced by the patient’s tumor, and these important treatment advances will require individualized assay-testing which can improve patient survival in chemotherapy for cancer. Assay-directed chemotherapy is an individualized approach to killing cancer. It’s time to set aside empiric one-size-fits-all treatment in favor of recognizing that breast, lung, ovarian and other forms of cancer represent heterogenous diseases, where the tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient’s cancer.

From yesterday’s Associated Press article:

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.   

Now,"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.   

Read the rest at USA Today

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. 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.   

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4 replies »

  1. I’m about the most straight laced old shoocl guy you’d ever want to meet, but this was just stunning. What a joyous celebration of life! Isn’t marriage something to celebrate? Of course, and these people did just that. How much nicer life would be if we could all celebrate the great things in life like these young people did. May they have many years of happiness!

  2. The cell profiling approach, holds the key to solving some of the problems confronting a healthcare system that is seeking ways to best allocate available resources while accomplishing the critical task of matching individual cancer patients with the treatments most likely to benefit them.
    Genomic testing is not the answer, without cell culture analysis. In developing a program to discover gene expression microarrays, which predict for responsiveness to drug therapy, the way to identify informative gene expression patterns is to have a gold standard and that cell culture assays are by far the most powerful, efficient, useful gold standard to have.

  3. Reuters reports that NCI Director Andrew von Eschenbach will give up his daily duties there to focus on his new job as acting FDA commissioner.
    I am enamoured by the thought of von Eschenbach’s belief that much of what has been done has been based on a model of empiricism, and doctors should be able to intervene with medical treatments more effectively matched to a specific patient’s illness (individualized treatment).
    We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform well-designed, prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination.
    The era of empiric, aggressive multi-agent cytotoxic chemotherapy for adult solid tumors should come to an end. We should put much more emphasis on matching the treatment to patient, though the use individualized testing, have more respect for minimal partial response or stable disease, when it can be achieved through the use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or agressive combination chemotherapy to those fortunate patients with tumor biologies most amenable to attack and total or near-total destruction by these aggressive treatments.
    He’s let the cat out of the bag, with his stated beliefs. I’m going to hold his feet to the fire from this moment on.

  4. It might help if physicians also kept this diversity of manifestations in diagnosis. A person I know went to ER for terrible stomach pain. The *symptom* was treated, and she was sent home. A few weeks later she came back with shoulder pain. She may have even resisted going back to the ER because the first time she had been treated like she was blowing her pain out of proportion. But she went, and this time they bothered to do some tests. It was colon cancer, and it was then too late. She died a few weeks later. She was in her early 30s.
    I’m hoping her family sues the hospital. I hope that by the time they recover from their grief enough to realize the hospital should be sued, their legal options won’t be exhausted and they won’t have to tell their story over and over again to a series of lawyers before one helps them out. I’m hoping that in the mean time some law that’s meant to stop “frivolous litigation” won’t put a cap on punitive damages. If the doctors had been in the frame of mind to diagnose instead of assuming vague symptoms in a 30 year old are “not likely” to be any real problem, then this person might have had a shot at being alive today.