Cancer Patients To Rally At FDA Tomorrow
5 CommentsBy Ed Silverman // September 17th, 2007 // 8:25 am
The growing frustration with the agency over the issue of approving experimental meds, particularly for cancer, is prompting the kind of activism last seen two decades ago among AIDS patients. Even a few 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.
So several of the more vocal patient groups are joining together tomorrow at 10 a.m. EST to protest outside FDA offices 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 Better 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.
Scott
Ed has it right. We believe it’s clear the FDA is broken. They are clearly failing to follow the mandate Congress set forth in the FDA Modernization Act of 1997, which, while creating an accelerated approval pathway for cancer therapies, also explicitly changed the FDA mandate from simply ‘protect’ the public health to protect AND PROMOTE the public health by promptly and efficiently reviewing and bringing new therapies to dying patients.
The legislation’s clear intent (stated in the deliberations) was to bring the FDA into the 21st century science and 21st century economy. The FDA has chosen to ignore this mandate and fails to use the science and tools of the 21st century that are available right now to help it approve and monitor these new therapies. Instead, stuck in its mode of deadly overcaution and riddled with conflicts of interest, the FDA ‘protects’ dying patients from lifesaving options. It’s unconscionable and unacceptable.
Please join us tomorrow at 10:00AM to raise your voices with ours and tell the FDA that this just will not be accepted any longer. Congress needs to step in and demand immediate hearings and explanations from the FDA. Pass the ACCESS Act, pass the Durbin Amendment, and pass a rider to PDUFA explicitly laying out what shall and shall not be considered in approving therapies for late-stage patients with few or no options available. Patients don’t have to die, unless we let the FDA continue its ways. We believe patients have A Right To Live. If you believe that too, join us tomorrow.
Visit the website at http://www.arighttolive.com for more information.
Thanks again to Ed for reporting on this news story. Hundreds of thousands of cancer patients have already died waiting for the FDA to act and approve safe and effective therapies for their cancers. More die every day. Let’s end the dysfunction at the FDA and help them join the 21st century.
Protect And PROMOTE the public health.
Provenge Now
Genasense Now
Junovan Now
Satraplatin Now
G-Vax Now
CHANGE AT THE FDA NOW!
Sincerely,
Scott Riccio
Founding Member and Advocate
A Right To Live
http://www.arighttolive.com
MyPharmalotID
Speaking of the Durbin Amendment, below are Secs. 701 and 712 of H.R.2900, the PDUFA legislation reported out of the House of Representatives and sent to the Senate. You may recall that the Senate defeated similar legislation, the Durbin Amendment, leaving the Senate PDUFA legislation without COI provisions. Now, the House and Senate PDUVA legislation must be reconciled in joint committee.
Personally, I think justice would be well served if the joint committee were unable to reach agreement in time to avoid a shutdown of the FDA,. One interpretation would lay the blame for the shutdown right at Pazdur’s, Scher’s, and Hussain’s feet for their having demonstrated beyond a shadow of a doubt why strong COI provisions must be part of any PDUFA legislation going forward.
It will be very interesting to see how this plays out.
H.R.2900
Food and Drug Administration Amendments Act of 2007 (Placed on Calendar in Senate)
——————————————————————————–
SEC. 701. CONFLICTS OF INTEREST.
(a) In General- Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting at the end the following:
`SEC. 712. CONFLICTS OF INTEREST.
`(a) Definitions- For purposes of this section:
`(1) ADVISORY COMMITTEE- The term `advisory committee’ means an advisory committee under the Federal Advisory Committee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.
`(2) FINANCIAL INTEREST- The term `financial interest’ means a financial interest under section 208(a) of title 18, United States Code.
`(b) Appointments to Advisory Committees-
`(1) RECRUITMENT-
`(A) IN GENERAL- Given the importance of advisory committees to the review process at the Food and Drug Administration, the Secretary, through the Office of Women’s Health, the Office of Orphan Product Development, the Office of Pediatric Therapeutics, and other offices within the Food and Drug Administration with relevant expertise, shall develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups. The Secretary shall seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities. The Secretary shall also take into account the advisory committees with the greatest number of vacancies.
`(B) RECRUITMENT ACTIVITIES- The recruitment activities under subparagraph (A) may include–
`(i) advertising the process for becoming an advisory committee member at medical and scientific society conferences;
`(ii) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and
`(iii) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person who the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.
`(2) EVALUATION AND CRITERIA- When considering a term appointment to an advisory committee, the Secretary shall review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in subsection (c)(3) of this section for service on the committee at a meeting of the committee.
`(3) PARTICIPATION OF GUEST EXPERT WITH FINANCIAL INTEREST- Notwithstanding any other provision of this section, an individual with a financial interest with respect to any matter considered by an advisory committee may be allowed to participate in a meeting of an advisory committee as a guest expert if the Secretary determines that the individual has particular expertise required for the meeting. An individual participating as a guest expert may provide information and expert opinion, but shall not participate in the discussion or voting by the members of the advisory committee.
`(c) Granting and Disclosure of Waivers-
`(1) IN GENERAL- Prior to a meeting of an advisory committee regarding a `particular matter’ (as that term is used in section 208 of title 18, United States Code), each member of the committee who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of such section 208.
`(2) FINANCIAL INTEREST OF ADVISORY COMMITTEE MEMBER OR FAMILY MEMBER- No member of an advisory committee may vote with respect to any matter considered by the advisory committee if such member (or an immediate family member of such member) has a financial interest that could be affected by the advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity of the services of the Government officers or employees to which such regulations apply.
`(3) WAIVER- The Secretary may grant a waiver of the prohibition in paragraph (2) if such waiver is necessary to afford the advisory committee essential expertise.
`(4) LIMITATIONS-
`(A) ONE WAIVER PER COMMITTEE MEETING- Notwithstanding any other provision of this section, with respect to each advisory committee, the Secretary shall not grant more than 1 waiver under paragraph (3) per committee meeting.
`(B) SCIENTIFIC WORK- The Secretary may not grant a waiver under paragraph (3) for a member of an advisory committee when the member’s own scientific work is involved.
`(5) DISCLOSURE OF WAIVER- Notwithstanding section 107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the following shall apply:
`(A) 15 OR MORE DAYS IN ADVANCE- As soon as practicable, but in no case later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet website of the Food and Drug Administration–
`(i) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination, certification, or waiver applies; and
`(ii) the reasons of the Secretary for such determination, certification, or waiver.
`(B) LESS THAN 30 DAYS IN ADVANCE- In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet website of the Food and Drug Administration, the information described in clauses (i) and (ii) of subparagraph (A) as soon as practicable after the Secretary makes such determination, certification, or waiver, but in no case later than the date of such meeting.
`(d) Public Record- The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c)(5) (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code).
`(e) Annual Report- Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report that describes–
`(1) with respect to the fiscal year that ended on September 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received for each committee, and the number of such nominees willing to serve;
`(2) with respect to such year, the aggregate number of disclosures required under subsection (c)(5) for each meeting of each advisory committee and the percentage of individuals to whom such disclosures did not apply who served on such committee for each such meeting;
`(3) with respect to such year, the number of times the disclosures required under subsection (c)(5) occurred under subparagraph (B) of such subsection; and
`(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the fiscal year following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, including those who are classified by the Food and Drug Administration as academicians or practitioners.
`(f) Periodic Review of Guidance- Not less than once every 5 years, the Secretary shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary.’.
(b) Conforming Amendment- Section 505(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended–
(1) by striking paragraph (4); and
(2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively.
(c) Effective Date- The amendments made by this section shall take effect on October 1, 2007.
Tony F
Ed,
A great reminder to the public whom advocates are asking for support for cancer patients by getting the FDA to just follow existing regulations which can permit the use of experimental and un-approved SAFE treatments for their TERMINAL conditions prior to approval of the treatment. Remember, we’re not asking for prompt access for a treatment for corns or hang-nails!
As noted, the gathering begins at 10 am EDT at the FDA in surburban Washington. It’s to be a peaceful demonstration supporting early access for victims of this terrible disease.
PLEASE JOIN US AT FDA TOMMORROW and support cancer victims! Advocates are traveling from all over the United States on their own time and funds from such diverse locales as Florida, New Jersey, Texas, Illinois, Wisconsin, Ohio…
3, 774 service personnel have died in the Iraq war, according to the DoD as of today in the several years of the war.
10, 770 men, at the rate of 83 per day, have died in the 120 days since “Black Wednesday” in May when the FDA turned down 2 treatments…..
… both tragic statistics.
Perhaps this RALLY wouldn’t have been necessary had several individuals such as Richard “Dick” Pazdur of the FDA cancer divison and the two infamous “temporary government employees” Howard Isador Scher of Sloan-Kettering and Maha Hussain of Michigian who apparently put their personal agenda’s ahead of science, regulations and TERMINAL patients.
For the record, Scher reported 3 Conflict of Interests to the FDA in order to be awarded a waiver to sit in judgment of Provenge at the FDA Advisory Comittee meeting in March.
Internet research shows the following for Scher thus far and please particularly note #1 and #17:
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
… and this list does NOT include that Scher is reported an “Executive” of and is on the “Board of Directors” at Sloan-Kettering in NYC.
Hussain appears to have not reported all of her COI’s including that her husband apparently treats his prostate cancer patients with chemo and owns shares in possibly competing companies.
Pazdur, in addition to being reportedly spazzed about not having Provenge’s AC under his division at the FDA, also may have a spouse who works at the NIH in cancer treatment trials which appears to me to be uncomfortably cozy and inappropriate.
Thanks for helping get the story out with accurate reporting and let’s get cancer victims early access to:
Provenge NOW - Genasense NOW - Junovan NOW - Satraplatin NOW - G-Vax NOW, in particular, and those other upcoming treatments which can help extend lives.
See you tomorrow at the FDA!
Ray
Thanks Ed for keep the rally news “in the news” on Pharamalot!
Hopefully the rally tomorrow will bring home to the FDA the “life & death” struggle that their delay of Provenge has wrought on all prostate cancer victims!
Thanks again…
Ray in Alabama
cpk
Thanks for the info on the rally tomorrow and thank you, Ed, for keeping this story at the forefront.
It’s really a remarkable response from patients, advocates and shareholders that they can put together such an effective movement against an FDA gone astray.
Even as a passive bystander, I am fully behind the people who make such an overwhelming effort. I hope that the people at the FDA show some dignity and walk downstairs to meet with some of the people asking what is holding up their one last best chance at life.