MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Now Comes Plaintiff, CareToLive, on behalf of its members and all suffering late stage prostate cancer patients and their families who have now been denied a proven safe and effective treatment for over two years and request leave from this Court to conduct a limited amount of discovery so as to more fully respond to the Motion for Summary Judgment filed by Defendant, as further set forth in the attached memorandum.

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

Popularity: 46%

Harry Markopolos, at the Bernie Madoff Ponzi Scheme Congressional Investigation.

Congressman Alan Grayson: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman Alan Grayson: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

Popularity: 68%

The Citizen Petition filed with the FDA by CareToLive has now been pending for decision with the FDA for 556 days. The Petition which asked the FDA to reconsider its decision to deny a license to Provenge, was followed up by 200 positive comments in the months following that filing, by patients, families of patients, physicians, scientists, researchers and other fine citizens.

The petition process is the only formal way for patients and their advocates to ask the FDA to consider and address their wishes.

It has been 384 days since CBER head Jesse Goodman wrote to CareToLive and said that they needed some additional time to decide the petition.

It has been approximately 372 days since a CBER employee told CareToLive counsel that a committee had been formed and they were actively reviewing the petition.

It has been approximately 365 days since counsel for the CBER division of the FDA told counsel for CareToLive that they took the petition very seriously and that while she could not say who was on the committee considering the petition, she could make the assurance that they were in fact actively reviewing it.

God bless all the patients that watch and wait. Stay strong!

Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016

Popularity: 62%

Hello Dr. Frank Torti,

Congratulations on being selected interim FDA Commissioner. After reviewing your biography and affiliations, I do indeed hope you get the permanent position. I hope that is what you are also hoping will happen.

You have your work cut out for you, good Doctor, as I firmly believe the FDA has lost its way. Politics, investments, and business relationships have really jaded their judgment as to what is best for the American people, who it is called and paid to serve. I also see too close an attachment to the National Cancer Institute (NCI), which has its own agenda, sometimes to the detriment of the American people that it is paid to serve.

I don’t play games and mince words, Dr. Torti, so I am just going to come out and say it. I do not apologize for the length of this treatise for the story must be told. The FDA is letting innocent people die. NCI is letting innocent people die. Whether it is for political favors, like I said above, investments, or business relationships, while in collusion with NCI and lobbyists, this is sincerely wrong and unethical. Just the fact that the visitors and employees who enter the main FDA headquarters in Rockville, Maryland, are greeted with Wall Street Journals instead of food and medical journals, is a very strong image of what is wrong here.

And now, I will give you an overview of the poster child for what is wrong with the FDA. You can let Richard Pazdur know, we will not stop until we get him bounced out of the agency you lead as the interim Commissioner. This self-serving, inconsistent, pompous director should no longer get paid with our hard earned tax dollars. We will take President Obama up on his promise to enforce full Freedom of Information Act compliance during his administration. The courts have ruled Pazdur has to turn over his documents in four months, by May 18, 2009. We will demand all of his documents and will be in contact with the President along the way.

Much has been said that the FDA employees are needing a bonus to help with their morale. We were sorry to hear this. Their morale did take a hit due to complaints filed against the FDA. Let it be thoroughly understood, we are not trying to hurt the morale of FDA staff. Our criticism starts with Richard Pazdur and his cohorts, Howard Scher, Maha Hussain and Thomas Fleming. Then it includes people at the top like Janet Woodcock. Get rid of these self-serving individuals, and watch the criticism stop, and the rest of the good people at FDA can do their jobs with a lot less stress.

Okay, now I will present the poster child for what is wrong at FDA and NCI. Thanks for your time and best of luck in your new position.

Respectfully,

CareToLive, a not for profit corporation

THE PROBLEM

Every year in America, close to 220,000 men are diagnosed with prostate cancer. That is one out of every six men. 96,000 of them will advance to late stage and close to 30,000 of them will die. The last treatment approved by the FDA for this patient population was Taxotere. That was almost 4 years ago. If you go to http://www.taxotere.com/ and look at the black box warning on the bottom of the page, you will see why these patients do not want to take it.

POSSIBLE SOLUTIONS ON THE WAY

1) Dendreon Provenge
2) Novacea Asentar
3) Cell Genesys GVAX
4) Cougar Biotechnology Abiraterone

WHAT WENT RIGHT

The Dendreon Corporation created Provenge and it is the closest to being ready as a possible solution. When it first started testing in the clinical trials well over ten years ago, it wasn’t looking at survival as a primary endpoint. As time went on, it did become rather obvious that it was indeed showing a survival advantage and survival is the gold standard for cancer treatments. In addition, it was showing very little side effects, just flu like symptoms for a couple of days. Since 30,000 men die every year here in America from this lethal disease and they have no other options, people took notice. The FDA even made a few strong statements when it granted it Fast Track Status, called for an Advisory Committee and granted Priority Review.

November 7, 2005 - Dendreon Announces FDA Grants Fast Track Status for Provenge

The FDA determined that PROVENGE meets the criteria for Fast Track designation in that PROVENGE shows the potential to improve survival in the intended patient population of men with asymptomatic, metastatic, androgen-independent prostate cancer. The potential of PROVENGE to provide a survival benefit was based on results from the primary Phase 3 efficacy study, D9901, and supporting data from D9902A, which were recently discussed with the FDA in a pre-BLA meeting.

Under the FDA Modernization Act of 1997, designation as a Fast Track drug product provides for expedited regulatory review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions.

January 16, 2007 - Dendreon’s PROVENGE Granted FDA Priority Review for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer

Priority Review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. The goal for reviewing a product with Priority Review status is six months from the filing date.

March 1, 2007 - Dendreon Announces FDA’s Cellular, Tissue & Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer

The U.S. Food and Drug Administration’s Office of Cellular, Tissue & Gene Therapies Advisory Committee will review the Biologics License Application (BLA) for PROVENGE (sipuleucel-T), the Company’s investigational active cellular immunotherapy (ACI) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer on March 29, 2007. The Center for Biologics Evaluation and Research (CBER) has oversight of the Cellular, Tissue and Gene Therapy Advisory Committee.

WHAT WENT WRONG

March 29, 2007 - The Provenge Advisory Committee Hearing

It became rather obvious that two doctors, Dr. Howard Scher and Dr. Maha Hussain, were going to contest Provenge during the entire hearing. Their arguments? Poor trial design and the fact that Provenge did not reach its primary endpoint. The FDA knew about both of these arguments going into the Advisory Committee hearing and it did not stop the FDA from going forward. The Spokesperson for FDA this day, Dr. Celia Witten, told the panel they were there because of the survival.

The Advisory Committee transcript can be found here: http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4291T1.pdf

These two doctors, Scher and Hussain, had to sign waivers to be on the panel because both had Conflicts of Interests. Both mirrored each other’s testimony. Here is an example of Dr. Hussain arguing about the trial design on page 85:

DR. HUSSAIN: So my question is
21 if you really believe survival is the gold
22 standard, why did you choose to design two
trials that have a problematic endpoint?

We perceived this acerbic remark as a refusal by this doctor to accept what many people already knew, these trials were designed years ago according to where the science was at the time. Elizabeth Smith of Dendreon responded to her:

MS. SMITH: Eight years ago when
3 Studies 1 and 2 were designed, progression
4 was an endpoint that was appropriate for
5 this patient population and was felt that
6 would provide important information for
7 these men, particularly who are
8 asymptomatic.

That apparently was not enough for Dr. Hussain because on page 184 she was at it again:

DR. HUSSAIN: Yes, I can’t help
12 but feel that there is an inconsistency in
13 the FDA position on what would be or would
14 not be accepted for a registration purpose.
15 So here we heard that survival is an
16 endpoint that is accepted. That’s not an
17 issue. That’s not a problem. In my two
18 years on ODAC, I am left with the impression
19 that, in a disease where there’s never been
20 surrogacy demonstrated, a progression-free
21 survival will not be accepted, or time-to
22 progression is not accepted.

Notice she says ODAC because the director of ODAC, Dr. Richard Pazdur, attended this meeting. His division of the FDA, CDER (the Center for Drug Evaluation & Research) was not assigned this Advisory Committee because Provenge is not a drug you pop in your mouth, it is a biologic. So CBER (the Center for Biologic Evaluation & Research) was correctly assigned this hearing. It became noticeable later that there is much fighting going on inside the FDA between these two divisions. We don’t think our tax dollars should have to pay for such fighting in this government agency. It is not right.

We are most certain Dr. Hussain is referring to Dr. Pazdur on page 183 when she says:

And there are some members
10 sitting in the back; they can confirm if I’m
11 misquoting.

We also have been told Dr. Pazdur passed a note to Dr. Hussain during the lunch break.

Dr. Witten, who is from the CBER division, was first introduced on page 4.

Dr. Celia Witten will be
10 the sole spokesperson for the FDA.

On pages 185-186 she answered Hussain’s continued complaining about trial design and the failed primary endpoint:

DR. WITTEN: Well, maybe I didn’t
6 explain it clearly, but we do collaborate
7 with the Center for Drugs in these
8 discussions about endpoints. But when there
9 are studies, they may be developed prior to
10 discussions, and so you have to look at the
11 study development based on where the science
12 is, where the field is, and, you know, the
13 FDA also, when they design trials, they have
14 to do it based on what the information is at
15 that time. So there may be subsequent
16 discussions that would affect studies, you
17 know, future studies in that area, but you
18 don’t go back, you know, I don’t think
19 anywhere in FDA that you then go back in
20 general and look at all the studies you have
21 ongoing and ask sponsors to redesign those
22 trials. So I think that’s, you know, that’s
true here. That’s true in other
2 indications. That’s true elsewhere. And,
3 you know, I think in this case, you know,
4 what we really are focusing on now is, is
5 survival, which I think is not disputable as
6 something that, you know, should be looked
7 at in one of these trials, or would be
8 desirable to look at in one of these trials.

Dr. Hussain continued her battle on pages 188-189, this time with a hypothetical question:

DR. HUSSAIN: If - so the sponsor
12 presented how changes in a couple of
13 patients brought the p-value down to 0.052,
14 and I understand the FDA position about not
15 accepting that. And supposing there was a
16 third patient, and that p-value came down
17 smack into 0.045. Does that mean if a
18 survival - in that setting, if the survival
19 was not a primary or secondary endpoint, and
20 their primary endpoint hit the p-value that
21 was unequivocally positive, would we still
22 be here? Do you understand what I’m trying
to say here?

Dr. Witten replied on page 189:

DR. WITTEN: Because I’m not sure
5 it’s a statistical question versus, you
6 know, just a general FDA question. And I’ll
7 just say it’s a little bit hard to answer
8 hypothetical questions like that. You know,
9 we’re given the application based on
10 survival. We think there’s no question that
11 this application shows that the study failed
12 in terms of time-to-progression. And so
13 what we would do if the study had shown
14 something else, I don’t think we really can
15 answer that. I think we, you know, we
16 really want to focus on what did the study
17 results as demonstrated in this study mean.

Notice Witten wasn’t ducking the questionable trial design Hussain and Scher were harping on. Nor was she avoiding the primary endpoint. They were there because of the survival, the gold standard.

So we have a good foundation of why this committee of FDA handpicked experts was called. Provenge was showing survival. Dendreon presented Provenge and then three FDA employees presented what they found when they studied the information Dendreon had sent them. All three FDA employees said at the end of their presentation, and I will give one here as an example, that they were looking for advice from the 17 panelists. Here is how FDA biostatistician Dr. Zhen said it on page 181 and note, he mentions FDA doctor, Dr. Liu:

DR. ZHEN: However, survival is not one of the
8 many, many endpoints that can be randomly
9 selected for testing. Survival is a
10 preferred endpoint for cancer trial. As
11 Dendreon and Dr. Liu just mentioned, this
12 endpoint is reliable, clinically meaningful.
13 This is why we are here seeking advice from
14 the advisory committee meeting.

Next, there was an Open Public Hearing where patients and advocates and even a doctor who administered Provenge were allowed to speak. The doctor, Dr. David Penson, went to the hearing on his own dime and his own time.

The hearing moved along with many questions being asked and many concerns being raised. Provenge was put on the table with all of its warts and blemishes. All the questions and concerns that were raised, mostly by Scher and Hussain, were addressed. Then the panel was asked to vote. Is Provenge safe? All 17 panelists said yes, even Scher and Hussain. Safety was not an issue.

The second question was a problem. The question was asked, Does Provenge establish efficacy? We would like to know where this question came from. For one, it is asking for the treatment to declare 100% that it works. No treatment has ever had to meet that standard. Second, it is not the Federal Regulatory question. It became obvious someone was interfering here. It was bad enough we had to tolerate two conflicted doctors from a division of the FDA that did not have oversight on this application and now there was a rigged question. The Federal Regulatory question is, Does Provenge show substantial evidence of efficacy?

Dr. Witten gave the regulatory question to the Advisory Committee Chairman, Dr. James Mule on page 378:

DR. WITTEN: Yes. The regulatory
9 definition is “provide substantial
10 evidence.” So that’s our standard. Is
11 there substantial evidence that it works.
12 Is there substantial evidence of efficacy,
13 if that helps. So is there substantial
14 evidence.

15 DR. MULÉ: Okay. So just to
16 clarify what you’re asking, is there
17 substantial evidence that the product is
18 efficacious.

19 DR. WITTEN: Yes.

The panelists voted. They voted 13-4 that Provenge did show substantial evidence of efficacy. Now one of the no votes was Dr. Chappell. He did not vote on the regulatory question, he voted on the tampered question as seen on page 382:

DR. CHAPPELL: No. Regretfully
16 and very sympathetically, I don’t believe
17 that the data establish efficacy.

Needless to say, Scher and Hussain voted no. Scher tried to jumble up the questions and Chairman Dr. Mule was on to him on page 386:

DR. MULÉ: Dr. Scher?

2 DR. SCHER: I think we are really
3 poised at the beginning of what will be
4 hopefully an outstanding era of
5 immunotherapy. I think there is sufficient
6 evidence demonstrated which justifies the
7 definitive study, and obviously there are
8 investors in that who concurred, but I think
9 it does not meet the — as the question was
10 phrased, to establish the efficacy. I think
11 this is still an open question.

12 DR. MULÉ: So I take it you’re
13 saying yes with these provisos?

14 DR. SCHER: We have two
15 questions. I would say yes to one, no to
16 the second. The first question as posed, as
17 established, I say no.

18 DR. MULÉ: No, it’s substantial
19 evidence.

20 DR. SCHER: I will say no.

Earlier on pages 382-382, Dr. Hussain did jumble up the questions when she said “establish” and “substantial” mean the same thing:

DR. MULÉ: Dr. Hussain?

22 DR. HUSSAIN: So to me
1 “substantial” and “establish” are the same,
2 and no to either. So no to both.

Therefore, 3 of the 4 no votes were not answered correctly. These three panelists refused to answer the Federal Regulatory question.

But the panel vote was in. The Advisory Committee advised the FDA in an overwhelmingly fashion. Thousands of prostate cancer patients and their families and their doctors were excited. But not so fast.

April 13, 2007 A Letter Is Leaked

Since Dendreon is a publicly traded company, it is important to note, there were 24 million shares short of the stock at the time of the Advisory Committee. That meant a lot of people were betting against Provenge and Dendreon. With such an overwhelming vote of support of Provenge, common sense would say that number should go down. However, on April 13th, just two weeks later, Nasdaq announced the short shares went up another 8 million to 32 million. On that exact day a letter written to the FDA was leaked by the FDA to the public via the internet. The letter was reported to have been written by Dr. Scher.

This reminded us of the leaked information during the ImClone case in 2002 that resulted in Martha Stewart going to jail. We then noticed some similarities. It has been reported Richard Pazdur leaked the ImClone info and it ended up in the hands of Paul Goldberg and was published in his non-peer medical publication called The Cancer Letter. Since we knew Pazdur was at the Provenge hearing and passing notes during lunch, we thought of him first. When we saw the letter ended up in the same place as the ImClone info, in the hands of Paul Goldberg and The Cancer Letter, we thought of him some more.

The tone of Dr. Scher’s letter was, if Provenge was approved, what happens to other treatments under development. This matched his testimony at the hearing as seen on page 322:

So if I start thinking, am
16 I denying a potentially useful agent to men
17 who clearly need it, the answer is
18 unfortunately I don’t know. So I say well,
19 what if we think that this really should be
20 available, start thinking about the number
21 of agents that are currently under
22 development.

He was worried about other treatments under development. We also noticed in his leaked letter he mentions he is leading a Phase III trial for a competitor, Novacea, and their treatment, Asentar, which is for the same patient population as Provenge. Red flags go up as we now wonder how he was even allowed on the panel and we now understood why he was fighting Provenge all along. But if he made his point at the hearing, why was a letter necessary? Plus, since he starts his letter by introducing himself to the FDA, like they didn’t know who he was, it became even more suspicious.

We started investigating Dr. Scher, all the while thinking about the timing of the stock market with the short share increase the same day his letter came out. Who knew what and how did they know?

Our investigation uncovered a company called ProQuest Investments. ProQuest was started in 1998 with the financial help of Michael Milken, the founder of the Prostate Cancer Foundation (PCF). Milken served time in jail for stock fraud and was banned from having any dealings with the stock market. He was banned for life. When he left prison, he still had a large amount of money from his stock market days. Milken raised money begging at Safeway stores and baseball games and football games for prostate cancer research. He also gave a huge sum of money to ProQuest, to help it get started. This seems to be challenging his ban from the stock market for life. ProQuest said its primary focus would be on prostate cancer.

We found out one of ProQuest’s founding partners, Jay Moorin, was sitting on the Board of Directors (BOD) of Novacea and that ProQuest was heavily invested in Novacea. We also noticed Dr. Scher was on the Scientific Advisory Board of ProQuest Investments and that he is the leader of the PCF Therapeutic Clinical Investigation Consortium. Several board members of PCF are also board members of ProQuest Investments.

  Dr. David Solit, Tommy Lasorda, Dr. Howard Soule, Dr. Howard Scher & Mike Milken

So we started to connect the dots: Scher advises ProQuest, ProQuest invests in Novacea and has a founding partner on Novacea’s BOD, Scher leads the Novacea Phase III trial which Provenge would deem unnecessary if approved so Scher tried to stop it at the Advisory Committee hearing. He was unable to influence other panelists so he writes a letter, obviously to be leaked, to make the public think there is something wrong with Provenge. In addition, in his letter Scher says there are statistical problems which were all addressed at the committee hearing and the panel still voted overwhelmingly in favor of Provenge. He also changed his mind about his panel vote saying Provenge is safe. This was all disingenuous of Scher especially considering that earlier that year he spoke at a Novacea symposium and said it was time to focus less on statistics and more on the patients. How quickly he forgot. Medpage reported this in February 2007, one month before Provenge Advisory Committee. It is interesting to note, Scher told Medpage that he receives grants and research support from Novartis, Novacea, Bristol-Myers Squibb and Sanofi-Aventis.

Two More Leaked Letters

Dr. Maha Hussain wrote a letter to the FDA. Like her counterpart Scher, she felt like she had to introduce herself to the FDA for whom she worked. This letter was leaked to the public on April 26th courtesy of The Cancer Letter. As far as we can tell, Forbes Magazine writer, Matthew Herper, was the first to break it on the internet and via e-mail, the day before the official publication date.

Then on May 4th, a third letter is leaked. This one by Dr. Thomas Fleming, a biostatistician from the University of Washington. He reiterated the tone of Scher’s letter by saying he too was worried about other treatments under development. He said, like Scher, he could not sleep since the day of the positive Advisory Committee vote. How did he know Scher couldn’t sleep? He mentioned Novacea twice in his letter and once again it was leaked to the public courtesy of Paul Goldberg and The Cancer Letter.

Four days later, the FDA made their decision. They wanted more data from Dendreon. The short share count had risen another 9 million shares so it was now up to 41 million when the FDA announced its decision. How did all the naysayers know to take that position?

Twenty-one days later, pharmaceutical giant Schering-Plough gave Novacea close to $500 million with most of it earmarked for Dr. Scher’s Phase III trial. These kind of deals don’t happen overnight and if Provenge was approved, this deal would not have been necessary.

The Reaction

All across the nation, patients, their families, patient advocates, doctors, nurses, lawyers and investors were stunned. All considered the decision by the FDA to be tainted and downright callous. It reeked with the idea that it is money before patients. The men had no other options, they were dying a severely painful death and, of all things, everyone said Provenge was safe, so what was the problem?

Add to the fact that the FDA sided with two doctors who required Conflict of Interest (COI) waivers and both kept arguing about trial design and primary endpoints which the FDA already knew about when it granted Provenge Fast Track Status, called for the Advisory Committee, and granted Priority Review. The FDA even had their own three reviewers state in the public record they wanted advice from the Advisory Committee. That committee did advise them, 17-0 Provenge was safe, 13-4 Provenge showed substantial evidence of efficacy.

Dr. Scher was obviously feeling the heat from his involvement here. He interviewed with Marilyn Chase of the Wall Street Journal and just made everything worse. Here is that quote:

“I try to keep to the high ground,” Scher said, adding that he doesn’t work with any companies in direct competition with Dendreon. He serves as advisor to Innovive, a small biotech not involved in prostate cancer, and works with Bristol-Myers Squibb in an unpaid capacity on early stage drugs that may hold promise in prostate cancer. He and his wife hold small amounts of stock in Biogen Idec and Pfizer, he said.

Notice how, in just three months, his investments and employment change. Or else, and probably more correct, he never tells it correctly. He does not tell the Wall Street Journal that he receives grants and research support from Novartis, Novacea, Bristol-Myers Squibb and Sanofi-Aventis. And which is it? He receives grants and research support from Bristol-Myers Squibb or he works in an unpaid capacity? And notice, Proquest Investments never comes up. Plus, as far as we are concerned, the Prostate Cancer Foundation should be listed as an employer because it pays him $3.2 million to be the chairman of its therapeutic consortium.

How did he expect people to believe him now? He said he didn’t work with any companies in direct competition with Dendreon. What does he call Novacea and the same patient population? We also found out he did work for the third treatment on the list above, GVAX by Cell Genesys. Note he admits working for Bristol-Myers Squibb, that firm made a compound that was used in the manufacturing of GVAX. GVAX was used in a promotional flyer sent out by PCF soliciting funds for prostate cancer research. PCF has little or nothing to say about Provenge but PCF gives Scher $3.2 for being on the consortium and gives Scher’s hospital an average of $15 million a year.

Further, Dr. Scher is a scientific advisor since June 2006 for the fourth treatment on the list, Abiraterone by Cougar Biotechnology. PCF endorses Abiraterone and so does the National Cancer Institute (NCI). NCI wrote to Senator Inouye of Hawaii and said it does not support Provenge but has a robust prostate cancer portfolio. NCI sent M.D. Anderson $13 million to help the Abiraterone clinical trials.

So the puzzle pieces are coming together. Dr. Scher let it be known he was worried about other treatments under development so he couldn’t say yes to Provenge. He was worried about Asentar, GVAX, and Abiraterone. So he was basically saying , “Forget Provenge and the fact that it is safe and showing survival. I am not working on Provenge, I got my hands involved with these other three drugs.” PCF, NCI and FDA backed him up on this as we found out through our investigation. But how did Scher ever get to be on the Provenge Advisory Committee? According to U.S. Title Code 18 Section 208 you have to disclose all of your investments and employers. If he did that, there is no way he is on this committee and almost single-handedly stopping a promising treatment. If one compares his waiver and his Special Government Employee form, one would be hard pressed to see he listed all of his investments and employees correctly. We seriously doubt that all these forms match up and do indeed reflect his actual jobs and investments. If they do not, that is a violation of Federal Law.

A bunch of folks gathered on the internet to discuss what happened here. A small group decided it would protest in Chicago on June 2nd at the ASCO convention. Dendreon had hoped it would be announcing the good news of approval at that convention, however, that hope faded.

Another protest was planned for June 4th, in Washington, D.C. This protest was going to be larger and it would involve several prostate cancer advocate groups.

Here Comes CareToLive

My wife and I live on the east coast. We could not attend the Chicago rally due to our jobs. We wanted to help so we put up a website and called it CareToLive.com. The sole purpose was to give people a place to go to read all the information about the Chicago protest. People in charge of that protest sent us the information as it evolved and we posted it on the website. Then we added the Provenge story. And then we added information about the Washington, D.C. protest as that info became available.

Once pictures came in from the Chicago rally, we posted them on the CareToLive site. Only 13 people could show up but it was enough to get the message out: The FDA didn’t do the right thing. The 13 people were mostly professionals, doctors, nurses, lawyers and business owners. All good upstanding citizens of our great country.

My wife and I were able to make the Washington, D.C. rally. We drove down for that. The FDA Commissioner Andrew Von Eschenbach agreed to meet with various prostate cancer advocate groups. CareToLive was not one of them as it was still just an information website. Dr. Von Eschenbach refused to look into the decision and refused to reverse the decision. The shock continued. How do you call for an Advisory Committee, which had immunotherapy experts on the panel, to look at a treatment that is safe and showing survival, and that panel votes 17-0 and 13-4, and still you delay getting this treatment to sick dying men who have no other options?

Mike Milken, Richard Pazdur, & Andrew Von Eschenbach

 On top of that, your FDA Consumer Affairs Department makes no bones about the fact that the FDA sided with the minority doctors who had no experience with immunotherapy, who had severe conflicts of interest, who leaked letters the FDA was supposed to keep close to the vest, and who admitted to seeing the survival. What is wrong with this picture?

Here is testimony by both Scher and Hussain admitting their inexperience and both admitting they saw the survival:

Dr. Scher no experience page 87:

DR. SCHER: Personally I have no
2 experience with this agent, so I’d just like
3 to ask the clinicians who have used it, we
4 all understand the difficulties assessing
5 time-to-progression and how it does not
6 associate with survival as we are currently
7 measuring it.

Dr. Scher observes the survival page 320:

DR. SCHER: Unfortunately it didn’t
2 meet the primary endpoint and then three
3 years later a survival analysis is reported,
4 it is observed and there’s no question that
5 this is the gold standard by which we live.

Dr. Hussain not an expert page 314:

DR. HUSSIAN: One area we have not touched on
6 here and I’m not an expert in immunology,
7 but it’s my understanding that the hormonal
8 environment impacts the immunologic
9 response. I don’t know if anybody cares to
10 comment on that later.

Dr. Hussain clearly sees survival page 307:

HUSSAIN: And as I read this, it is clear that
18 there is a survival difference, so we’re not
19 disagreeing on that.The question is does
20 one believe that the survival difference is
21 related to a therapy effect.

All their questions and concerns were addressed at the hearing by folks who were experienced with immunotherapy and who were experienced with Provenge.

Dr. David Penson testified as follows on page 209:

That means my institution
6 receives research support, but it also means
7 I have firsthand experience with this agent.

And on page 210:

With that stated, I want to start
12 by saying that I firmly believe that
13 Provenge is effective and will extend life
14 in androgen-independent prostate cancer,
15 based on the clinical trial data showed
16 today.

Dr. Paul Shellhammer also testified at the hearing and he answered all of Scher’s question because Dr. Shellhammer had experience. He led all the Phase III trials. He saw what Provenge was doing.

Now why the FDA would side with inexperienced doctors can only be because of its business relationships with certain doctors, NCI and PCF.

The Investigation Continues

By July, it was obvious the FDA wasn’t going to budge. Even a half page ad in the Washington Post did not help. CareToLive decided to set itself up as a not for profit corporation and it filed a Citizens Petition. That Petition asked the FDA to reverse the Provenge decision on the grounds that conflicted doctors interfered with the process, the regulatory question was tampered with, letters were leaked and men were left dying in pain with no other options. This was an emergency. This petition still sits unanswered at the FDA. It can be seen at http://www.caretolive.com/caretolivepetition.pdf

 So then CareToLive filed a lawsuit. After pleading, begging, advertising, writing countless letters to the media and our elected officials, it was the only option left. We were looking forward to a court case so we could show what really went on here. Immediately, all doors, windows and shutters were slammed in our face. The discovery was blocked and the courts decided the case was not ripe for review yet, as a final decision on Provenge has yet to be made.

In September 2007 several cancer patient advocate groups held a large protest outside the FDA Headquarters in Rockville, MD. In addition, CareToLive and other patient advocate groups placed ads to further advocate for the immediate approval of Provenge.

We were hoping to get some help from the Supreme Court but it appears to be busy with other pressing issues. This is amazing since a man dies every 20 minutes in America from late stage prostate cancer.

Meanwhile, we were able to get some information thanks to the Freedom of Information Act (FOIA). We didn’t get all the information but what we got was some interesting information. As I have been hinting along the way, NCI and PCF seem to be instrumental here. We found out via the FOIA that Dr. Scher had help writing his letter. Alison Martin at NCI helped him as she worked on her computer at NCI. We were able to get the letters with editing and e-mails showing this collusion. However, they redacted an important e-mail from Scher to Martin where Scher was offering his personal opinion. NCI blocked it out and as we demanded it, they said they couldn’t give it because Alison Martin doesn’t work there anymore. Ms. Martin now works for Michael Milken, the chairman of the PCF.

Dr. Von E first said he had no documents and then later he turned them over. Richard Pazdur has been fighting us tooth and nail regarding his. We went back and forth in court about it and the judge ruled he has to turn them over by May 18, 2009. We can’t help think, if he did nothing wrong, why does he have to hide these documents and fight us so strongly about them.

In addition, we noticed there are Federal Regulations for Advisory Committee. One such regulation says the Advisory Committee Chairman, in this case Dr. James Mule, should be at all the meeting regarding the committee. We don’t think he was invited to the Scher/NCI meetings.

Some Congressman did ask for investigation. Here is their letter: http://caretolive.com/wp-content/uploads/2008/01/congressional-hearing-letter1.pdf

Senator John Dingell and Subcomittee Chairman Frank Pallone denied the investigation. They said the FDA didn’t make a final decision, we ask Dingell and Pallone to ask the John Fish, Richard Ripp and Stephen Study families if it was final. These three CareToLive members died while waiting on the FDA. Then Dingell and Pallone gave weak excuses. First, they said a preliminary glance showed no conflict of interests. All that we have shown here shows that is not true. And if it was a preliminary glance, when does the real glance take place? Second, they said the COI rules have been changed. That change we feel came about because of our challenge and we don’t believe it changed enough. But the fact of the matter is, this rule change came after the damage was already done so it is a weak argument. And just the fact that NCI helped write the leaked letters and the FDA, the FDA, leaked them should have been enough to investigate!

Richard Ripp & Stephen Study
CareToLive members who died while waiting for the FDA

Here is the denial for an investigation: http://caretolive.com/wp-content/uploads/2008/02/micha001.pdf

An Update On The Four Treatments

Novacea announced they stopped the Asentar trials due to a higher death rate in the treatment arm on Nov 6, 2007. The FDA gambled and went along with Scher and, sadly, men were poisoned as a result.

Cell Genesys announced they stopped the GVAX trials because of excess deaths in the active arm on Aug 28, 2008. More men died needlessly.

Cougar Biotechnology’s lead researcher announced on July 22, 2008 that he hopes to have Abiraterone ready for general use by 2011. At least 60,000 men will die before it is ready.

Dendreon announced good interim data from Provenge on Oct 6, 2008. The data provided from an Independent Data Monitoring Committee stated Provenge shows a safe profile and that is shows a 20% survival advantage over placebo. On April 28, 2009, Dendreon will announce the final data. Dendreon announced on April 14th, that the trial met its pre-specified end points.

Dr. Torti, there is more but this is plenty for now. Suffice it to say the FDA, NCI, PCF and Wall Street are all against Provenge. The recent IDMC data showed a 20% survival. FDA, NCI and PCF will all tell you close to 30,000 men die each year. 20% of 30,000 is 6,000 lives could be saved. What is the FDA doing here? Did they forget the Fast Track Status and the Priority Review and the reason for both?

And please keep in mind, this 20% survival advantage is just a tip of the iceberg. Immunotherapy always requires ramp up time.

In addition, Dendreon’s stock has a history of Wall Street manipulation. Dendreon recently joined 14 companies to write a letter to the SEC and asked the SEC to stop the shorting of their shares.

What sealed it all for me was not only listening to Dr. Penson and Dr. Shellhammer at the Advisory Committee hearing. I had the opportunity to speak to a doctor not too far from my home who had administered Provenge. He said he gave Provenge to men in the trials. He said, and he did not flinch, stutter or blink his eyes, that Provenge works. He saw it. Pazdur, Scher, Hussain, Fleming and Milken never saw that. They never experienced it.

Let me know if you have any questions and I can fill in any and all blanks. We are asking for FDA accountability, transparency and reform. And now I will leave you with some quotes from American citizens who spoke out after the FDA delayed Provenge. Please approve Provenge now!

Best Regards,
CareToLive

REACTION TO THE FDA’S DECISION TO DELAY PROVENGE

“This is the first-ever cancer vaccine that targets established tumors. If this drug is approved, it will just open up more investigation in this area. This drug is very, very non-toxic.” - Dr. Johannes Vieweg

“It is a vaccine in the sense that it juices up the immune system.” - ABC News Medical Editor Dr. Timothy Johnson

“He told me it looked pretty bad. I believe in Provenge because of the way I used to feel before the treatment and the way I felt afterwards. It was that dramatic.” - Eduardo Garcia who took Provenge seven years ago

“Realistically, we have people who are dying of prostate cancer who can really utilize these pharmaceuticals and can utilize them now.” - Urologist Dr. David Allen

“This is not like classic chemo; there is no loss of hair, no sickness associated with it. We are disappointed because I think that many of the people who are involved in the study, many of the site investigators who are experienced with the drug , feel that it’s a safe drug and that it works… that it extends life in a very desperate group of patients.” - Dr. David Penson

“We think a mistake has been made.” - Dr. Mark Moyad

“We are disappointed that it’s not going through and that it has to go back on the table to be approved. And, certainly, we’ve heard from our patients who are not happy about it.” - Urologist Dr. David Samadi

“Tens of thousands of men like me will die before they get it.” - Prostate cancer patient and advocate, Joel Nowak

“There are so many men around this country that are livid. They’re angry that this drug has not been approved.” -Prostate cancer patient and advocate Steve Fleishman

“No. Oh, please, no.” - Prostate cancer patient Jim Lanpher

“When I went back to my support group, and I’m a support group leader, and I told these men that the FDA has delayed the approval of this, I watched tears coming down their cheeks because they had all their hope in trying a treatment that was going to have few side-effects and was going to prolong their life.” - Prostate cancer patient and advocate Jim Keifert

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The Sixth Circuit Court in Cincinnati, Ohio has granted the request of CareToLive to present oral argument in Appeal No. 07-4465 which is the appeal of the Southern District of Ohio Court decision (case # 07-729).

Oral arguments will be heard on July 29th at 1:30 pm at the Potter Stewart United States Court House, 100 East Fifth St., Cincinnati, Ohio.

Argument will be before a three judge panel. The identity of the three judge panel will not be identified until two weeks before the oral argument date.

Also, Thanks to all the participants that helped make the first ever Coast to Coast prostate cancer demonstrations a huge success!

Continue Reading CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal! »

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I will try to keep this brief to give a short overview of the situation. The facts are out there for anybody who wants to examine this further. You may also email us for further info.

http://youtube.com/watch?v=6Q0uQAL_YDA Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW! (More videos and photos coming soon)

Who We Are

Care To Live is a non profit group, who formed for the sole purpose of challenging the current status quo of the prostate cancer standard of care for end stage prostate cancer. We are trying to prod our fda, our government, our medical community, our advocacy groups, and our investment firms, into embracing the better science of immunotherapy, and to consider the people first, over their profits.

Neither the Board of Directors, nor any Care To Live member or friend, including our Attorney, Kerry Donahue, receive any salary. We are volunteers from around the world, who care about the health and well being of people everywhere and are concerned that there are better treatment options which are being overlooked. We saw the immunotherapy Provenge, and what it can do, and we feel it is our duty to stand up and fight for it. It is not easy to challenge and change the current entrenched cancer treatment options. Many of us are dedicated to stay at this until Provenge is approved. We want better, safer, more humane treatments, NOW!

We are funded by small contributions from people who want to promote Provenge and Immunotherapy as a standard of care in fighting cancer. We are joined by a few great advocacy groups who support us, such as Abigail-Alliance, A Right To Live, and the Cancer Cure Coalition. We did get some additional support from Us Too, but by and large we are mostly ignored by the advocacy groups. We can only surmise that they must perceive immunotherapy as a threat to their personal agendas.

The beauty of Care To Live is that they cannot buy our silence, and they know we will never sell out for any price. We are determined to see immunotherapy brought into the 21st century.

Dendreon, the company that discovered the immunotherapy Provenge’s targeted antigen cassette delivery system, also has similar treatments in their sight for breast, colon, ovarian, lung, kidney, and cervical cancers, etc.

Are there any treatments for end stage prostate cancer?

One new treatment has been approved by our FDA in 43 years. It is a chemotherapy, which is so toxic, that most men who understand the consequences of taking it, refuse to do so. Some men will die directly as a result of the treatment. If it is successful they can expect a life extension of an extra 2 1/2 months filled with extra pain and suffering due to the severe side effects of the chemotherapy, as the cancer and the chemotherapy ravish their bodies.

What is Provenge?

Provenge is a non invasive, non toxic, targeted immunotherapy which utilizes one’s healthy cells to fight end stage prostate cancer. It is administered in 3 infusions as an outpatient using one’s own white blood cells, to mount an attack against the cancer. Some men are living as long as 7 years after the three treatments they received 7 years prior. The side effects are usually limited to a day or two of fever and chills as your body builds up an immune response.

Can I get Provenge?

No.

Provenge went before the FDA over a year ago to apply for a license. They spent years consulting with the FDA who granted Continue Reading Denial is a River of Blood at the FDA »

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Read/Download Richard Ripp Rockville Gazette Ad richardrippgazettecolor.pdf

(click to enlarge) (available to print as a full page poster on the protest page)

Richard was featured in our Rockville/ Bethesda / Chevy Chase Gazette Ad campaign in Week #6. We so appreciate his standing up to help shed light on the Provenge fiasco and do his small part to help raise awareness of the terrible decisions that are being made at the FDA. We will miss Richard very much. Our hearts go out to his family and friends for sharing Richard with us for a little while. He was truly a great American, who stood up for the things he believed in, right up until the end.

Richard Ripp’s funeral is being held Friday May 30, 2008. How fitting that we will get to remember him during our nationwide protests. Richard Ripps name needs to resonate from one Coast to the other as we express our extreme sorrow for him and the 30,000 men who are slated to die this year from prostate cancer while Provenge, an immunotherapy shown to be safe and effective, with 10 years of trials under it belt, along with an overwhelmingly favorable FDA Advisory Panel vote, lays and rots on the shelves, with no explanation or scientific reasoning from the FDA.

PLEASE HELP US GET PROVENGE TO OUR MEN NOW!

Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

We have to continue doing everything we can to get Provenge to our men who are running out of hope and time. Please join with us in raising awareness for this very important issue and if you can, come out on May 30 to raise your voice to get Provenge Approved NOW!

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Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

The FDA’s Cancer Chief Speaks Out by Catherine Arnst
In a discussion with BusinessWeek, Dr. Richard Pazdur talks about clinical trials, small biotechs, and anxious patients
http://www.businessweek.com/bwdaily/dnflash/content/
may2008/db20080521_549448.htm

Steve Walker of Abigail Alliance writes a rebuttal:

May 23rd, 2008 at 10:32 am

With respect to the following:

We cannot approve drugs on the basis of emotion, says Pazdur. We cannot make drugs available at the expense of lowering standards of approval. difficult to argue with that logic. But it’s not likely to make cancer patients, or oncology-focused drug companies, feel any better.

To those of us who have been listening to and, much more importantly, following the actions of Dr. Pazdur over the last 7 years, his response regarding “lowering approval standards” is the kind of classic, disingenuous and condescending misdirection he is renowned for among those who have to deal with him on material matters, like approval decisions for safe and effective drugs.

Continue Reading FDA Health Czar Richard Pazdur Needs to be Replaced - He Turned His Back on the Public’s Health »

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There was ample of evidence of survival benefit conferred by Provenge as a treatment in contrast to Dr. Pazdur’s statement: “Believe me, if there were a clear survival effect, the drug would be approved,”. In fact, Dr. Pazdur’s focus on the statistical flaws showed that the main problem in the FDA drug approval process as practiced by Dr. Pazdur is a slavish following of rigid statistical rules without properly factoring in clinical knowledge required to give meaning to such numerical data.

The irony is that FDA has a process to incorporate clinical knowledge into drug evaluation. Advisory Committees made up of world-class experts are often convened to discuss clinical data and provide advices to the FDA during the evaluation of drugs up for approval. The AC convened to consider Provenge voted 17-0 that the drug was safe and 13-4 that there was substantial evidence that it was effective. When Dr. Pazdur helped rejecting Provenge, he effectively ignored that body of knowledge. He showed himself to be not only a slave to simple statistical calculations but also one who cared little for the scientific process and the needs of desperate patients.

For Provenge, the clinical data were:

1. D9901, a phase 3 trial enrolling 127 patients, whose primary endpoint, Time To Progression, barely missed statistical significance with p-value .052 and Overall Survival was highly significant with p-value .01. The survival rates at three years were 1 in 3 for patients treated with Provenge compared to 1 in 9 for patients treated with placebo. Per several sensitivity analysis performed by the FDA statisticians themselves, this trial was well run, the data self-consistent and the survival benefit unlikely to be spurious.
2. D9902a, a smaller phase 3 trial enrolling 98 patients, missed statistical significance Continue Reading FDA’s Richard Pazdur Cares Little for the Scientific Process and the Needs of Desperate Patients »

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Week #7 Rockville/Bethesda/Chevy Chase Gazette Ad Campaign

Please visit the FDA Protest 5/30/08 page and help us spread the word. There is much that everyone can do to help raise awareness. Thanks. CareToLive

Read/Download Richard Wick Bethesda/Chevy Chase/Kensington Gazette Ad richardwickgazettead.pdf

Popularity: 45%