Ella Does Squamish

MyPostID2 wrote:

This was an easy story to get right and the fact the reporter didn’t calls into question how much other stuff the Post does not get right.

The drug has been demonstrated to be safe in three and three-quarters Phase III trials, three Phase II trials, and one Phase I trial. The expert advisory panel voted 17-0 the drug was safe. The most common complaint is 2-4 days of flu-like symptoms each of the three times the drug is administered. (From the publicly available FDA documents accessible on the web)

Contrast this with the only approved drug for this stage of prostate cancer, Taxotere. Between 1-2% of men die from the side effects of this drug. The deaths, almost all of which occur in the first two months of treatment, significantly shorten the normal 18-20 month life expectancy of these patients (New England Journal of Medicine reports on Taxotere TAX-327 and SWOG-9916 trials).

It is no wonder over 50% of men refuse to take Taxotere. Seven courses of Taxotere (147 days) create about two months extra median survival with about 24% of men alive at the end of three years (ASCO 2007 presentation, available on the web).

Provenge involves three treatments in the lifetime of the patient, or about six days total medical treatment. The median patient lived 4.5 months longer. 33% of men who received Provenge were still alive at the end of three years (FDA documents and Journal of Clinical Oncology, available on the web).

The expert advisory panel convened by the FDA weighed this information carefully and voted 13-4 that the clinical data on Provenge provided "substantial evidence of efficacy." (FDA documents available on the web).

Drs. Hussain and Scher were invited to this FDA advisory panel. Both are experts in treating prostate cancer with chemotherapy, but neither has any particular expertise with immunotherapy. The remainder of the panel, with the exception of two invited advocates, are immunotherapy experts. Several had participated in a joint NCI/FDA conference on cancer immunotherapy that clearly communicated a shift in opinion on how this new class of drugs works and how the old ways — ways that Drs. Hussain and Scher are schooled in — are no longer appropriate. While Drs. Hussain and Scher are often billed as the only two "cancer experts" on the panel, they were the two people least qualified to accurately judge this new form of therapy.

Both voted ‘no’ to the efficacy question, but both voted ‘yes’ that the drug was safe.

Drs. Hussain and Scher are entitled to their opinions, of course. While people were disappointed they could not overcome their entrenched, outdated views on cancer treatment, their votes were what they were and the vast majority of people in the patient advocacy community accepted them at face value.

Where advocates and others got really upset is when first Dr Scher, and then Dr. Hussain, wrote letters to the FDA both knew were to be leaked to the media. The letters contradicted their testimony and vote that PRovenge demonstrated safety. The letters were mean-spirited, petty, and underscored why neither were suitable choices for the advisory panel in the first place.

Both Drs. Hussain and Scher were added to the panel only after receiving a conflict of interest waiver. After the unprecedented extra step of sending in the letters, people started investigating what motivated them to send the letters. It turns out both have conflicts of interest that were not disclosed to the FDA. Dr. Scher is particularly guilty as he, among other undisclosed conflicts, works for a hedge fund who has a Board seat on a biotechnology company with a competitive drug to Provenge. Dr. Scher only disclosed he is the lead investigator for the company’s pivotal trial (itself an ethical conflicts given his financial relationship with the company), and not that he has a direct financial interest via his hedge fund employer in the success of the competitive drug in the marketplace. It is unknown whether this hedge fund profited from the decline in Dendreon’s shares, but it would be interesting to find out.

For the Post to leave out this information denies the reader proper context to why people are so angry with this decision. The fact that Provenge has been tested in seven different clinical trials with a safety record superior to all available therapies was left out. The FDA expert advisory panel votes (17-0 on safety, 13-4 on efficacy) were, astonishingly, left out.

Perhaps the editorial board of the Washington Post will require a second story on Provenge in order to correct these deficiencies. If they take seriously their responsibility as a paper of record in our nation’s capitol, they should jump on the opportunity to do the right thing here. If the Post’s editorial board doesn’t, then they simply are one more rag good Americans shouldn’t bother to read because they cannot even get the easy stories right.

7/6/2007 4:34:18 PM