Yesterday I left Philadelphia for FierceBiotech's annual trip to BIO. The 2010 conference is being held in Chicago where, over the next four days, FierceBiotech and FiercePharma will bring you live coverage of this year's event.
I always look forward to covering sessions and speaking with industry experts about the lastest trends in the drug development world. But as it turned out, my first interview would be conducted not at the show, but in the shuttle to the airport.
Ashley Oehler, Laura Vickers and Diane Jones were all leaving Philadelphia after attending Living Beyond Breast Cancer, the fourth annual meeting exclusively for women with metastatic breast cancer. With acceptance and even humor, they spoke frankly about their experiences with cancer, from dealing with remission and recurrence, to facing mastectomies and hair loss. When the conversation turned to clinical trials and experimental treatments, I had one simple question for these women: If you could speak directly to the pharmaceutical and biotech companies that develop breast cancer therapies, what would you say?
A whole lot, as it turns out.
All three women were frustrated by the lack of available clinical trials for Stage IV patients. "We know they can't let us into trials for earlier-stage cancer because we might interfere with their results," explained Vickers. But perhaps, she suggested, companies could run parallel studies for patients with late-stage cancer. As Oehler observed, patients with metastatic disease don't have years to wait for the next new drug, and many women have already been on every currently approved therapy. "We're willing to try anything," explained Oehler. The women expressed a desire for better resources for finding clinical trials, so patients can more easily figure out who is eligible for which trials, especially since the criteria for inclusion in clinical trials is often complicated.
Oehler, Vickers and Jones also felt that the exchange of information between drug developers, physicians and patients can be frusturating. When pharma does come to patients, it's to talk about their drug, not to listen to what patients say, noted Oehler. And oftentimes when physicians come to talk about a drug, they're paid spokespersons for a drug company. Patients, it seems, want a better back-and-forth communication with drug companies so that they feel their voices are being heard. "They should pay us to come talk to them," quipped Oehler. Other concerns included, not surprisingly, the ever-rising cost of drugs; the patient's out-of-pocket costs for participating in clinical trials; and an increased use of alternative medicine used in conjunction with traditional therapies.
For me, speaking with these cancer survivors highlighted the ongoing dilemma of drug development. Improvement in communication and resources could solve some of their complaints. However, gaining access to potentially life-saving drugs presents a different predicament given the current economic environment and the constant pressure to keep costs down. Providing unapproved drugs to patients outside of a clinical trial can be extremely expensive, entails a certain amount of risk, and requires the FDA's support. Added to that is the financial burden of meeting the FDA's ever-increasing demands for stringent clinical data. Companies have so much riding on each clinical trial that they must do everything possible to maintain the integrity of their results--and that often means excluding patiens who have tried everything else.
Collaboration between patients, the drug industry, governmental agencies, researchers and even the private sector is needed to re-examine the clinical trials process so that the scientific integrity of clinical trials can be maintained while meeting the immediate needs of late-stage cancer patients. In this time of great technological advances and scientific achievements, patients, the industry and regulators are still searching for ways in which the current model of drug development can be improved to get new therapies to patients faster and at less cost. If you have a vision of how to tackle the challenges presented by this life-threatening disease, please share your insights with us.
FierceBiotech and FiercePharma will be reporting live from Chicago this week. Check out this page to keep up-to-date with all our BIO2010 coverage, or follow @FierceBiotech and @FiercePharma on Twitter for breaking news from the show. We look forward to seeing you in Chicago! - Maureen Martino (twitter | email)