Cancer Patients To Hold Sept. Rally At FDA
6 CommentsBy Ed Silverman // August 22nd, 2007 // 4:52 pm
For those who haven’t noticed, there’s a growing frustration with the agency over the issue of approving experimental meds, particularly for cancer. Several companies, such as Pharmacyclics, are openly resisting FDA decisions. The Abigail Alliance patient group plans to appeal a court ruling that experimental meds shouldn’t be given to the terminally ill. And controversy continues over the FDA flip-flop on approving the Provenge prostate-cancer vaccine.
Now, some of the more vocal patient groups are joining together with plans to protest outside FDA offices on Sept. 18 in Rockville, Md. The event is being organized by A Right To Live, which has been active in criticizing the FDA’s handling of Provenge; the Abigail Alliance for Access to Developmental Drugs, and the Cancer Cure Coalition. Here’s the press release with a few details.
The two-hour rally - which is likely to include some investors in Dendreon, the company testing Provenge - will celebrate what’s being called “A Right To Live Day.†And they’ll protest “recent decisions by the FDA to deny cancer patients new, potentially lifesaving therapies, including Provenge for terminal patients with late-stage prostate cancer.” It’s not clear how many people are expected, but given the media coverage of these interlocking controversies, the event is certain to get a lot of publicity.
Dr. Sal Giorgianni
Without sounding too much like a Child of The Sixties (which I am) this is just the type of social activism that gets the attention of legislators who have oversight over the FDA. The agency exists to serve the public good, which, as any student of sociology will tell you, is defined by the public itself – not the agency and not the technical experts that advise the agency.
In the 1980’s when I was working in a PhARMA company’s regulatory policy group one of my assignments was to attend, observe and report back on the proceedings and the impact that AIDS activist rallies had on FDA’s perspective on the IND process and approval procedures for anti-retroviral and related compounds. Let me tell you these rallies had an enormous impact. It is my view that these public displays of outrage and angst did more to advance the nature of the drug approval process in the US – for all categories of products – than any single other commission, initiative or Congressional inquiry.
Some call these tactics coercive – maybe. But some call them legitimate and unfettered public expression of the public-will – absolutely. FDA should listen to these advocates and give high level consideration to the important message they are sending. They must begin to develop lines of communications to help not only provide less dramatic – but equally pointed – forums for dialog and then not just leave it at that but to take the legitimate dialog and shape it into policies and procedures that make sense for the 21st Century
Tony F
Ed, ‘ppreciate your letting us know about the FDA Rally at the FDA in DC on the 18th!
It’s incredible to see several cancer groups getting together to let the FDA know their displeasure at the continued withholding of potentially life savings or life extending treatments for cancer victims just because they have NOT jumped thru all the FDA’s hoops.
Folks may not know that the Abigail Alliance has championed several drugs–including one that may have help Abigail Burrough–and each has eventually received the FDA’s stamp of Approval.
The question is: “Why wasn’t it given to non-clinical trial cancer victims once those treatments were deemed “substantially safe” by the FDA?”
Untold and countless lives have been lost that could have otherwise been extended or saved.
This is shameful in a country of wealth and knowledge such as the USA in the 21st century.
Come support cancer patients in DC on Sept 18th. Info is at http://www.arighttolive.com and http://www.caretolive.com
… and Thanks for your article, Ed!
phil_vardena (Pharm. D.)
Thank you Ed.
Please keep your beam of light on the FDA and Provenge in particular.
We need answers:
A couple of weeks after the FDA delaying letter regarding Provenge, on May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc.(a competitor to Dendreon) up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?
Also, did Novacea and Schering-Plough Corp. arrange the deal in a couple of weeks?
What did Dr. Sher and Dr. Hussain know when they sat at the panel?
Subsequent research shows Dr. Sher is also involved in Proquest, a healthcare venture capital firm with over $875 million under management.
Dr. Howard Scher is a Scientific Advisory Board member for Proquest Investments
Proquest owns shares in Novacea (now, an interesting question would be: Does Dr. Howard Sher own shares in Novacea?).
Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?
Only two oncologists took part in the Advisory Committe panel (the others being immunotherapists, urologists, etc.) and BOTH have substantial relationship with a competing company!
Who did choose to have Dr. Sher and Dr. Hussain in the panel, out of thousands of good oncologists out there? And why?
We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
Regards,
phil
Kyoto27
Ed, there’s not only a growing frustration with the agency over the issue of approving experimental meds, particularly for cancer…but also over the lack of transparency when the FDA overrules an FDA appointed advisory panel.
In the case of Provenge, the FDA’s move to overrule its panel was unprecedented because the agency had never before ruled against a positive panel finding in a terminal illness. And, of course, it begs the question, why now?
It also begs the question which I hope you will ask of our Congress, and the FDA:
When making ruling against a panel in a terminal illess finding, shouldn’t the FDA be mandated to list the names of those who voted against the panel, and a summary of their arguements as to why similiar to what our Supreme Court makes public after its findings? Given the life and death issues involved, it does not appear to be asking much of “our” FDA (and it also would help to shine the light on any potential conflicts of interest).
The checks and balances we have in place for the Executive Branch–particularly with regard to a Veto, are not in place re FDA veto power. Making their findings public is the least we can do and hope you Ed can help all of us gain more transparency.
Given the stakes, it is not asking too much from “our” government, or appointed agencies.
MyPharmalotID
While Vince Vardena is throwing out a few questions, I have some of my own. Perhaps Congress, SEC, the DOJ/FBI, GAO FraudLine, and HHS/OIG or HHS/OIA could provide the answers to these questions:
1. Who asked Dr. Scher (and, possibly, Drs. Hussain and Fleming) to write their letters to the FDA? What was the motive in having these letters written and in mounting what clearly was a major PR campaign to sink Provenge approval?
2. Did Drs. Scher, Hussain, and Fleming receive any assistance in the development of their letters? If so, who assisted them? Were any of the people who assisted them associated with companies that are competitors of Dendreon in the prostate cancer space? Were any of the people who assisted them associated with financial institutions that held positions from which they would benefit if Provenge were not approved?
3. Who leaked the letters written by Drs. Scher, Hussain, and Fleming to The Cancer Letter? If FDA and HHS investigators have been unable to identify the source of the leaks, have they brought in the FBI? If not, why not?
4. This isn’t the first time that information regarding an action pertaining to a cancer drug was leaked to The Cancer Letter. Previously, the Refusal to File (RTF) letter in the case of ImClone’s Erbitux drug was leaked to this tabloid newsletter before it was released to the company? So, who is the mole inside the FDA and why hasn’t he or she been caught and prosecuted?
5. What do these leaks indicate about the level of document security within the FDA? Is the security of other propriety data jeopardized? How can the pharmaceutical and biotech industry place any confidence in the FDA’s ability to safeguard their proprietary data if the agency can’t even protect three sensitive but unclassified letters?!
6. Was the full extent of Dr. Scher’s relationship with Novacea and ProQuest Investments fully disclosed in the waiver request? That is, in addition to his work with Novacea on the Asentar Phase III clinical trial, did Dr. Scher own stock and/or options in Novacea (and/or Schering-Plough, which signed a $440 million deal with Novacea for Asentar at the end of May 2007, some 3 weeks after Dendreon was sent its CR letter)? A paper published in Lancet in 2003 (Lancet Oncol 2003; 4: 407–14) contained a note to the effect that Dr. Scher had stock holdings or option holdings in Cell Therapeutics, Vidamed, ProQuest, Conforma, and Genta. Did Dr. Scher still have stock holdings or option holdings in ProQuest at the time of the Provenge Advisary Committee meeting? If so, what is the extent of these investments?
7. Did Dr. Scher’s waiver request indicate that the Asentar Phase III clinical trial involves both Asentar and Taxotere® (docetaxel), the latter being the only competing treatment currently approved for AIPC?
8. Are there any undisclosed conflicts of interest involving family members of Drs. Scher and Hussain that should have been reported? For example, Dr. Hussain’s husband currently is conducting prostate cancer trials with Taxotere®; how would the enrollment in these trials have been affected if Provenge been approved last May?
9. Given the appearance of such strong conflicts of interest in the matter, how could Vince Tolino, Director, Ethics and Integrity Staff, Division of Management Programs, OM, even consider sending the request for a waiver on for consideration? Put another way, are the plans, policies, processes, and procedures within the agency adequate to address what appears to be an egregious example of conflicted interests on the part of Dr. Scher?
Inquiring minds would like to have the answers to these questions (among many others!)
Tom Smith
MyPhamalotID Hopefully the lawsuit against the FDA will shed light on these questions! IMHO as far as the SEC or DOJ goes they are in bed with the big hedge funds so forget them helping out! As far as the FDA goes they too are in bed with BIG CHEMO PHARMA and that is the real reason why Provenge was not given full or even conditional approval!