FDA Blocks Life-Saving Cancer Drug Rally

phil · 11-28-2011, 09:40 AM

Feeding off our Petition, " FDA Blocks Life-Saving Drug " ( Google it and please sign ! ), we at " Our Her2 Cancer Struggle " ( FB) are having a Rally. Tuesday, December 6th. 11:30 A.M. At the Flagpoles in front of Boston City Hall. Survivor Speakers are all lined up , and supporters.
Any Her2 + Survivors and Supporters are welcome . We will invite the Press. We will present a printed copy of the Petition to the local Federal HHS officilas immediately after the Rally. They are waare, and cordial. They are not the Target. This FDA and Genentech are. We will ask for a face to face mtg. in DC with Dr. Sebelius.
We encorage Avastin Survivors to Rally , and send thier own message to DR. Sebelius : This FDA is Blocking Life -saving Drugs from thousands of Her2 +, and TNBC Survivors . A pattern of obstructing the Accelerated Approval program , since 2009. Women, and men are DYING !! Speak Up !!

ElaineM · 11-28-2011, 10:50 AM

Good luck at the rally. I signed the petition and sent the link to some other people a long time ago.
I can't be a the rally. I am 5000 miles away.
Take care.

hutchibk · 11-28-2011, 05:57 PM

Dr. Sebellius is an obvious target, but I am curious, why Genentech? They are as unhappy about this as we are. I promise.

phil · 12-02-2011, 07:27 PM

While its true that Gen. wanted the drug approved , it was w/ mixed motives. $$ is always afactor in their top CEOS decision-making. Some in the co. wanted to close Expanded Access right after the FDA declined approval. But were persuaded not to. Also did not extend access to much of the country , after FDA denial. No return on their investment. Now they have closed access. And they are keeping my wife from Boston, w/ low platelets shes an investment risk.
So FDA is the main problem here, but we need an FDA that works for us, and keeps an eye on how Big Business sells medicines. While they make wonderful dugs, and want to save lives, they also will make BILLIONS per year on this drug . Dont be fooled. The top execs at Gen. are as far removed from the chemo rooms as Dr. Pazdur over at the FDA. The Systemis crooked. Witness how this FDA handles so-called compassionate use, they tell pts, " Dont contact us, have your doc call the Co. IF THE CO. SAYS OK , we'll review it. Many co's wont give single pt or so -called comp. use, becuas eits an INVESTMENT RISK ! What if you have an un-related health crisis on thier drug. If youre Gen. , w/ this antagonistic FDA, you are screwed, so Speak up ! This FDA Oncology Review Div. needs an overhaul, and some real compassion for Stage IV pts.

phil · 12-03-2011, 08:40 PM

As far as I know, Genentech has not granted ANY single pt. access for T DM-1. And many pts in dire straits have asked. So much for compassionate business.

hutchibk · 12-03-2011, 09:07 PM

I am a pt in compassionate use of T-DM1. I fly a distance to get it... The FDA has prevented them from granting access just because a patient wants it... the FDA requires ALL data to be collated into their approval processes. The real argument is with the FDA.

Lani · 12-03-2011, 09:30 PM

Edited away to the point of deletion

Soccermom · 12-03-2011, 10:47 PM

Signed and Facebooked!
Thank you!
Marcia

phil · 12-04-2011, 07:46 AM

Expanded Access is NOT comp. use ! Single pt access is . " Comp. Use " is a name given by Congress to that part of the Acc. Approval Program, wher apt's Dr. asks the co for single pt. access. Co's are reluctant to give it, as I stated above, risk of un-related health probs. Gen. does NOT give any compassionate use for this drug. We are very happy that you got into the T DM-1 EAP. Gen. was going to close it last Oct 31, until we had our Sen. Kerry's office and Congr. Stephen Lynchs' office call. Plus an old friend of Ted Kennedy. Thanks to them , Expanded Access was kept open , until Sept. 6th, 2011.
We wouldnt be having to have this discussion except for This FDA. But everything happens for a reason, and it brought to light how Big Business Selling Medicine needs regulation. Past experiences w/ the original herceptin Lottery, denying Stage Iv pts single pt. access, even current med . shortages ( because theres no $ in generics ) , all point to the need for some regulation.
We are not anti-business , or anti- govt, but pro-patient !

ElaineM · 12-04-2011, 10:27 AM

Have you read the book "The Making of Herceptin" or watched the movie "Living Proof" about what it took to get Herceptin approved? It took many years of struggles to get Herceptin approved. It might be a good idea to read the book or see the movie for background information since Herceptin is part of T DM1.

schoonder · 12-04-2011, 11:26 AM

On subject of T-DM1, I find it hard to believe that insufficient interim data has been collected so far from two phase II trials and three phase III trials for FDA to make a provisional approval decision, while subject trials continue to provide input into final approval package.
Of course letters from Breast Cancer Action group that imply Genentech is looking for a quick out, circumvent approval process by use a so called expanded access trial in lieu of proper phase III testing and BCA's insistance that conduct of mandatory phase III trials are all incluse and have last touches put upon before final decision is made, surely don't help this issue.
http://archive.bcaction.org/index.ph...-fast-tracking

KDR · 12-04-2011, 02:53 PM

Go, Phil! And thank you! You know I am behind you and Lorraine all the way! Go, Phil!
The members I know and conversate with here think you are amazing--and I told you that during our own conversation this weekend...we all sincerely thank you for what you've done for this cause.
Karen

annmask · 12-07-2011, 03:29 PM

I agree that the lack of support from advocacy groups for us stage 4 folks is really upsetting. Their explanation refers to the problem of women in the late 90's being given radical stem cell transplant therapy due to early trial results. As we know now, those poor souls suffered horribly with no benefit regarding survival. The quality of life issue is the opposite here with new targeted therapies that take so long to reach patients. I get so depressed when I read about new exciting research that end with "we hope to get this to patients in 5-10 years." We do not have 5-10 years, and we are not throw always! We matter!

Jackie07 · 02-01-2012, 01:49 PM

Received a reply today from the Congressman of our district:

Thank you for contacting me regarding the Food and Drug Administration's (FDA) drug approval and oversight responsibilities. I appreciate having the benefit of your comments.

While I understand your concerns, Congress does not have primary jurisdiction over drug approval or revocation. Consequently, you may wish to contact the FDA directly. The Commissioner may be reached at (888) 463-6332 or at the following address:

United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
http://www.fda.gov

I appreciate having the opportunity to represent the interests of Texans in the United States Senate. Thank you for taking the time to contact me.

Sincerely,

United States Senator

schoonder · 02-01-2012, 06:58 PM

It looks to me Congressman's gracious response wasn't all that helpful, actually it was short on substance. Recommendation to contact FDA directly, the organization responsible for making that inexcusable decision not to review T-DM1 phase II data because not all BC treatments, regardless of her2+ status were accounted for, in hope to see decision overturned, borders on nonsensical.
A much better response would've been if Congressman had asked the FDA Oversight Subcommittee to have a look at this far reaching ruling, which may well have its roots in regulations that haven't been revised to account for state-of-the-art, targeted drugs, high in efficacy, low in toxic side effects.
://en.wikipedia.org/wiki/United_States_House_Oversight_Subcommittee_on_Heal th_Care,_District_of_Columbia,_Census_and_the_Nati onal_Archives

phil · 02-07-2012, 02:37 PM

jackie : sounds like a" bureaucratic brush-off " from your Congressman/woman. Condescending in that obviously we know they dont have " operational " control. Their HELP Committee has over-sight, and has known about this problem for a yr., and done NOTHING !
I would call the no., ( or e-mail her at margaret.hamburg@fda.hhs.gov ). Ask her if shes seen Lorraine on the youtube video. We would be happy to meet with her in person, anytime.
We meet with our Regional HHS Director next week. Hope to get a meeting in DC with Sec. Sebelius, the FDAs' boss.

fullofbeans · 02-09-2012, 09:21 AM

Go Phil!

With the increased speed of scientific discovery:it is time to change regulation for stage 4 patients indeed. There is no sense of emergency.

I also agree there is a complete disregard from the charities and perhaps this is due to the fact that things have been changing fast in the last decade and they have not yet caught on.

Her2 is the most studied target, all scientists agree about the need to combine it for greater effect..yet..years are passing.. the thing is that many oncologists/medical profession are also getting frustrated at this.

A targeted organised campaign is in order worldwide.

fullofbeans · 02-09-2012, 02:29 PM

Phil,

What regulations would like to campaign for exactly?

PS: petition signed.

fullofbeans · 02-09-2012, 04:17 PM

Being the devil's advocat: Another example that may be used although I do think that Tdm1 has much more proof..

..should there be new regulation for people that have exhausted standard therapy..or say third line therapy..

http://en.wikipedia.org/wiki/Gemtuzumab_ozogamicin

Gemtuzumab ozogamicin (marketed by Wyeth as Mylotarg) is a drug-linked monoclonal antibody that was used to treat acute myelogenous leukemia from 2000-2010. It was withdrawn from market in June 2010 when a clinical trial showed the drug increased patient death and added no benefit over conventional cancer therapies.

Gemtuzumab is a monoclonal antibody to CD33 linked to a cytotoxic agent from the class of calicheamicins. CD33 is expressed in most leukemic blast cells but also in normal hematopoietic cells, the intensity diminishing with maturation of stem cells. In the United States, it was approved under an accelerated-approval process by the FDA in 2000 for use in patients over the age of 60 with relapsed acute myelogenous leukemia (AML); or those who are not considered candidates for standard chemotherapy.[1]

phil · 02-12-2012, 06:51 PM

My primary focus roght now is to get t dm-1 approved. It would be " nice " if Genentechs top execs would give compassionate use to Stage IV Her2 pts in the meantime. They know what a powerful drug they have.
Then we can focus on changing The Crooked System. get rid of Dr. Pazdur and his top advisers. They are blind scientitists. So invested in being " scientiific " that they are " un-scientific ", so " rational " that they are " irrational ". T DM-1 will be their stumbling block. Science is known for its blunders as much as its successes.
I havent fully thought out systemic changes, but I would start w/ giving Stage IV pts Flexibility, expanded access at all Phase of testing , especialy Phase III , 14 day wash-outs to get in, flexible tx planning while your in the access program. , give extra time for counts to rebound, lower or raise doses , etc. Do your rigid trial testing with earler Stage pts., . Sign Informed Choice Consents. Take away some of This FDA's power to decide For Us " Benefits vs. Risks '. We Decide !
Then I would focus on this Racket called " Single Pt. Access, or so-called " compassionate use ". Right now its a Con, a Cop-out by This FDA. They wont talk w/ Pts, tell us " Have your doc contact the pharm. co, if the co. says ok, have them contact us ". Putting us at the mercy of Global For-Profit Companies ! And docs who are conservative by training, reluctant to take risks, relutant to challenge Big Pharma, or This FDA . They'll be black-listed from trials. Comp. use is a Fraud !
So, I say change the law, get an FDA that advocates for US, The People ! You will talk to us, and if we are Stage IV , you will approach the Global Mega Corporations for us !
As far as drugs like this G... whatever, I dont know what the pt. death rate was, I do know what the death rate for CML was not so many yrs ago, 100% or close to it ! many drugs have saved lives through accelerated approval, some have not worked. I go with what Lorraine said at the Rally " Give Us a Chance ", an informed chance !