Over the past couple years, there has been a battle raging to help get the drug Provenge approved by the FDA. Many people have brought up conflicts of interests among FDA panelists as reasons that Provenge has not been made available to the public as of yet.

Last week, Jim Edwards who writes the Pharma Analysis blog over at bnet.com wrote a piece titled SEC Probe Into Dendreon Cancer Drug “Conspiracy” Could Put Rumors to Rest. In the post, Jim writes:

The conspiracy theorists believe that the FDA was swayed by a “disparaging letter” about Provenge written by Scher to the FDA commissioner, and that coupled with his conflict of interest this maneuvering unfairly kept Provenge off the market — and doomed many men to die unnecessarily from prostate cancer.

On its face, it does look messy: It’s always bad to have people with conflicts of interest in positions of power.

But a closer look reveals that both Scher and Hussain’s conflicts were disclosed prior to their sitting on the panel, and Scher’s letter contains an entirely reasonable and highly persuasive argument for not approving Provenge at the time — the company didn’t have enough data.

In fact, Dendreon had only presented “secondary endpoint” results, not primary endpoints. In other words, they had cherry-picked their data from two studies in which Provenge failed to meet the primary endpoint goals.

Having read this, Frank Burroughs, President of the Abigail Alliance, felt compelled to respond to Jim in a note which I’ve included below.  The Alliance definitely feels like these issues are real and it is important that people understand this fight.

What your article most certainly should have included was the lopsided FDA Oncologic Drugs Advisory Committee (ODAC) panel’s vote infavor of approving Provenge back in 2008.  The ODAC was convinced prostate cancer patients were being helped by Dendreon’s vaccine.

Sadly your article downplayed Drs.Scher and Hussain’s serious conflict of interest.  You should have been critical of the FDA for allowing them to be part of the Provenge review process in the first place.

Let me make one last note.  Even if the FDA wants more data for Provenge and other drugs and vaccines, what is so vitally needed for patients fighting for their lives, who have run out of options, and like so many cannot get into a clinical trial is early access to drugs and vaccines like Provenge, before the final FDA approval.  This is what the Compassionate Access Act will do that is close to being reintroduced in the U.S. Congress.

I think journalism gets measured by the quality of information it presents, not the drama or the pyrotechnics associated with us.         – Bob Woodward

Please respond in comments if you guys have thoughts on this issue.  We’d love to hear it!

Mason Researchers Launch Innovative Clinical Trial for Colorectal Cancer

George Mason University Published January 19, 2010 By Marjorie Musick

Imagine if treatments for disease could be based not on patients’ diagnoses, but instead on the characteristics of their tissue. By identifying and decoding the cryptic messages hidden deep inside the human proteome, scientists and physicians who study personalized medicine are seeking more effective treatments and disease management for patients.

Lance Liotta and Emanuel Petricoin III, professors of life sciences and co-directors of Mason’s Center for Applied Proteomics and Molecular Medicine (CAPMM), are pioneers in the field of patient-tailored research and personalized medicine. The two study biomarkers (indicators of disease in tissue and bodily fluids) related to cancer, heart disease, liver disease and obesity.

They recently launched a unique clinical trial in partnership with oncologists and co-principal investigators Kirstin Edmiston, medical director of cancer services at Inova Health System, and Alexander I. Spira, director of Fairfax Northern Virginia Hematology Oncology Research Program, to treat patients with late-stage colorectal cancer, a fatal cancer that starts in either the colon or the rectum.

Striking more than 150,000 American men and women each year, colorectal cancer is the nation’s third most commonly diagnosed cancer and third leading cause of cancer death, according to the American Cancer Society.

The three-year trial will accommodate up to 50 men and women who have late-stage colorectal cancer that has spread to the liver.

“Traditionally, all colon cancers have been lumped together and given similar treatments. The novelty about this is that we can, in a very minimally invasive way, start to treat the metastatic tumor based on its unique protein makeup,” says Edmiston.

“If we’re going to be successful in treating the metastatic disease, which is what kills people, then we need to focus on using therapies targeted toward the individuality of a patient’s disease state. This clinical trial is the first step toward doing that.”

Trial participants will be treated with standard metastatic colon cancer therapy and will test the addition of Gleevec, a medicine that is typically prescribed for certain forms of leukemia and gastrointestinal tumors. Gleevec targets disease pathways in tumor cells that previous CAPMM research revealed were among those found in typically fatal liver metastasis in colorectal cancer patients.
Because the primary tumors in the colon are removed in most colorectal cancer patients as soon as they are diagnosed, this study will focus on treating the often fatal secondary tumors or metastatic lesions that appear when the disease spreads to the liver, causing death through destruction of that organ.
To sample these lesions, CAPMM’s scientists developed a new drug target mapping technology called “reverse phase protein microarray.” This allows the researchers to create a unique molecular profile or “fingerprint” that shows which protein pathways or drug targets are activated in the lesion. This process will allow the researchers to determine whether specific drugs such as Gleevec might be an effective treatment for a particular patient before it is even administered.

By monitoring the drug target activity in trial participants’ tumors and basing their treatment on those characteristics, the researchers are hopeful that the clinical trial will lead to more effective and individualized treatment for patients suffering from this devastating disease.

“The exciting aspect of this trial is that an established drug is being considered for a new indication, and that’s one of the promises of personalized therapy — that a patient’s molecular portrait would be considered as the rationale for choice of therapy rather than based on the site or the kind of cancer alone,” says Petricoin.

“Until now, the most cutting-edge clinical trials utilize genomic profiling of the tumor to select patients. This is the first trial that uses a direct proteomic approach that maps the drug target activation networks that are in use in each patients’ tumor — just technologically being able to do this in a real clinical trial is a first.”

Patients interested in participating in the clinical trial should contact Stacey Banks, Inova’s clinical research coordinator, at 703-776-3565.
Financial support for the study is being provided by Novartis, which developed and manufactures Gleevec.

Posted by our Abigail Alliance friends at the Lung Cancer Alliance on their website 12-17-09

LUNG CANCER ALLIANCE DISAPPOINTED WITH
FOOD AND DRUG ADMINISTRATION COMMITTEE RECOMMENDATION
Panel Votes Against Approval of Tarceva® as Maintenance Drug

Washington, DC [December 17, 2009]— Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva® (erlotinib) as maintenance treatment for advanced lung cancer patients.
The Drug Evaluation and Research Oncologic Drugs Advisory Committee (ODAC), a panel of independent medical and scientific experts and patient representatives that reviews drug safety and efficacy data, voted 12-1 against the approval. The panel’s vote is not binding on the FDA which must reach a final decision by January 18, 2010.
At issue is whether Tarceva should be approved for first line maintenance monotherapy treatment for patients with locally advanced or metastatic non-small cell lung cancer and for those patients who have not progressed on first line treatments with a platinum based chemotherapy.
“We are very disappointed with this recommendation,” said Laurie Fenton Ambrose, Lung Cancer Alliance (LCA) President & CEO. “While we understand the importance of statistical analysis when evaluating drug approval, the Committee’s recommendation fails to appreciate the practical patient applications, especially with no safety concerns noted. The result is additional limitations on already limited options.”
Lung cancer is the leading cause of cancer death in the United States. It takes more lives than breast, prostate and colon cancers—combined. Over 70% of lung cancers are diagnosed at an advanced stage when curative surgery is not an option. Tarceva® is critically important to many lung cancer patients as it provides an option with limited side effects and portability.
“I was given two months to live when I was diagnosed almost five years ago. Tarceva® changed my life,” said Mike Stevens, four and a half year late stage lung cancer survivor and LCA-California Chair, in a statement read at the meeting. “During the nearly four years I was on Tarceva, I was able to travel with my wife for our 25th wedding anniversary, watch my daughter start college and my son turn 16. I truly owe my life and the quality of my life to Tarceva®.”
“We hope that FDA leadership will not follow the recommendations of ODAC and will approve Tarceva® in the maintenance setting so that lung cancer patients have another option that will help them live longer and enjoy a heightened quality of life,” concluded Fenton Ambrose.
To view LCA’s complete statement read at ODAC, click here.
As the only national non-profit organization dedicated exclusively to patient support and advocacy for those living with or at risk for lung cancer, Lung Cancer Alliance is committed to leading the movement to reverse decades of stigma and neglect by empowering those with or at risk for the disease, elevating awareness and changing health policy.