Conflict Of Interest And How Howard Scher & Maha Hussain & Richard Pazdur Hijacked Provenge's Approval

By Reza Ganjavi

Oncologists Howard Scher and Maha Hussain tried to derail the approval of a life saving prostate cancer drug, Provenge, which to date has been prescribed to over 30,000 men, by their negative propaganda at and after the FDA Advisory Committee which had an overwhelming YES vote, but FDA went with the powerful minority with apparent conflict of interest and delayed the approval of Provenge for a very long time. This really helped the short sellers in Dendreon. Dendreon was led by a medical doctor as CEO who made a killing for himself (over $25 million) when FDA finally approved the drug, after short sellers made a killing. Most medical doctors don't make good CEOs and Mitch Gold was not a good CEO at Dendreon. Dendreon was later acquired after shareholders got wiped out.

Also after this AdComm disaster, and activist pressure on FDA (including our activist team), FDA finally mandated that doctors on the AdComm need to issue a conflict of interest form before attending the meeting! Too little too late. But better late than never, especially given the fact that powerful hedge funds are known to have links to some doctors.

Long painful story whose victim were cancer patients who were denied a life saving drug as a bunch of suckers derailed / delayed FDA approval.

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In 2007, a 17 member FDA advisory panel of experts voted overwhelmingly to approve Provenge, Dendreon's prostate cancer immunotherapy biologic agent. The panel voted that Provenge is safe and effective. Subsequently two of the doctors on the panel who unbelievably had received wavers from FDA of their conflict of interest -- and there is debate whether they disclosed all their conflicts of interests, rallied against Provenge's approval. And Provenge did not get approved. And meanwhile in the US alone some 30,000 advanced stage prostate cancer men die every year, and about 1/2 of them do not consider chemotherapy to be a viable option because of its terrible side effects. Provenge has virtually no side effects. Let's face it. The chemo people and the hedge funds that bet hugely against Provenge won!

A lawsuit has been filed by Caretolive against the FDA et al. (see below).

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13 DEC 2007

Congressmen Mike Michaud, Dan Burton, Tim Ryan called on the House Energy and Commerce Committee to conduct a hearing to examine the conflict of interests governing the Food and Drug Administration (FDA) and its recent decision on failing to approve licensure of Provenge.

“Many ethical questions remain about the two panelists who voted no on approving this drug,” Michaud said. “I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge. Congress needs to get to the bottom of this. I believe a full disclosure is necessary in order to restore confidence in the FDA.”

“We need to ensure that the FDA gets life-saving drugs to the market as quickly and as safely as possible,” Michaud stated. “Our priority is to ensure the prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.”

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October 9, 2007

FDA Industry Insiders Derail Approval of New Cancer Treatments

Reprinted with permission

http://www.opednews.com/articles/genera_evelyn_p_071009_fda_industry_insider.htm

by Evelyn Pringle

FDA Industry Insiders Derail Approval of New Cancer Treatments

George W Bush's FDA, stacked with insiders from the industry that literally carried him to Washington, has stooped to a new low to protect the obscene profits of the multi-billion dollar cancer industry by blocking the approval of a new class of immunotherapies that can extend the lives of dying cancer patients with minimal side effects.

In the May 14, 2007, Wall Street Journal, a former medical officer in the FDA Office of Oncology Products, Dr Mark Thornton, denounced the FDA's decisions, and stated, "May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday."

"Within an eight-hour period that day," he wrote, "the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer."

Experts say, the new immunotherapies hold promise for many forms of cancer. "FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers," according to Dr Thornton.

With the approval of the new therapies, the profits, along with the horrendous side effects of the only treatments now available, could become a thing of the past. "One day current treatment approaches such as surgery, radiation and chemotherapy, which often kill most but not all of a cancer, could be made obsolete by a potent immune response that eradicates the cancer cells and provides subsequent protection against return and relapse," Dr Thornton wrote.

As such, the new therapies pose a grave threat to the cancer industry as a whole, and the lost profits would not be limited to the sale of products. The pharmaceutical giants have spent a small fortune to gain control of every segment of the industry, from researchers to government regulators, and every year, billions of dollars flow through a nationwide network of research institutions and treatment providers under the guise of finding a cure for cancer.

However, the profits up for grabs have become so enormous that critics say the goal of industry-controlled research is no longer focused on finding a cure for cancer to save lives. Instead, the focus is on thwarting the development and approval of new therapies in order to protect the profits of the treatments already on the market.

The FDA's refusal to approve Provenge, a new immunotherapy vaccine manufactured by the Dendreon Corporation, has caused major outrage in the cancer community. Provenge supporters have sent thousands upon thousands of letters and other correspondence to the FDA, members of Congress, the Department of Justice and others.

In addition, the Ohio-based non-profit corporation, CareToLive, has filed a lawsuit on behalf of terminal cancer patients seeking a declaratory judgment that the FDA acted "arbitrarily" and "capriciously" by denying patients access to Provenge, in violation of their constitutional right to live.

Dendreon sought approval to treat late-stage androgen-independent prostate cancer (AIPC) patients who have no other options. A study presented to an FDA Advisory Committee at a March 29, 2007, meeting showed that, after 36 months, 34% of the men who received Provenge in a clinical trial were still alive, compared to only 11% of those who received a placebo.

Provenge is designed to stimulate the patient's own immune system to specifically attack only cancer cells, unlike chemo drugs that attack any fast-growing line of cells.

Patients who qualify for Provenge have already had their prostates removed or have undergone radiation and hormone therapy. Eligible patients receive a one-time round of treatment consisting of 3 visits to a urologist's or oncologist's office to give blood, and 3 visits for the blood enhanced with Provenge to be infused back into the body.

On September 10, 2007, CareToLive filed a motion asking the court to issue an order enjoining the FDA from denying the marketing and distribution of Provenge. The plaintiffs charge that within six months, another 15,000 patients will have died waiting for justice.

The memorandum filed with the motion points out that the only available treatment approved for terminal AIPC in the last 42 years is a chemo drug, Taxotere. "The effectiveness of Taxotere," it states, "is so superficial, and the side effects so severe, that most men decline the treatment, as the risks far outweigh the benefits."

According to the filing, between 300 and 600 patients per year die from the Taxotere treatment itself. "This is truly amazing," the memo states, "considering the cost of the treatment and the cost of hospitalization and that the average benefit is an increase in survival of only 2 ½ months."

In contrast, the Provenge safety profile is so good that nobody has died from it and less than one in four patients experience side effects consisting of mild flu-like symptoms lasting one or two days, the memo notes.

The defendants named in the lawsuit include Mike Leavitt, Secretary of the US Department of Health and Human Services; FDA Commissioner Andrew von Eschenbach; Dr Richard Pazdur, head of the FDA's Office of Oncologic Drug Division, and Dr Howard Scher, chosen by Dr Pazdur to serve on the advisory panel set up to review the approval of Provenge.

CareToLive is represented pro bono by Attorney Kerry Donahue, of the Dublin, Ohio law firm Bellinger & Donahue, while the FDA officials are represented by a legal team of 11 government attorneys, at last count, funded by tax dollars.

The plaintiffs allege that the defendants engaged in a conspiracy to prevent the approval of Provenge and that Dr Pazdur, "purposely located two conflicted oncologists who he was sure for a variety of reasons would be anti-Provenge and he instructed them to try to derail the approval of Provenge."

The plaintiffs charge that, by choosing Dr Scher, and also Dr Maha Hussain, to serve on the advisory panel, Dr Pazdur "likely found two of the most conflicted oncologists in the country to sit in judgment of Provenge, and who would both assuredly continue his plot to lobby others at the FDA to vote for non-approval."

At the behest of Dr Pazdur, and for their own future political and monetary gain, the plaintiffs claim, "these two oncologists did everything they could think of to obstruct and impede the approval of Provenge."

The waiver of conflicts of interest granted by the FDA to Dr Hussain, which allowed her sit on the panel, reveals that she is the lead investigator on a research contract awarded by a company that competes with Dendreon, and her husband owns stock in three competing companies valued at between $15,000 and $300,000.

The lawsuit alleges that, as part of the conspiracy, on May 9, 2007, the FDA denied terminally-ill patients access to Provenge, even though the FDA Advisory Committee recommended approval, found the vaccine safe by a 17-0 vote and found there was "substantial evidence" of efficacy with Provenge by a 13-4 vote.

In an attempt to derail an approval recommendation by the panel, the plaintiffs claim that, prior to the vote on efficacy, Dr Pazdur and "his co-conspirators changed the statutory question regarding efficacy from 'substantial evidence' to 'absolute certainty' of efficacy, in an effort to obtain a 'no' vote on Provenge."

However, during the voting, this manipulation was discovered and promptly corrected by the FDA's Dr Celia Witten and Dr Jesse Goodman, and by an overwhelming majority, the panel voted "yes" to the revised efficacy question.

"It is unprecedented for the FDA to overturn the Advisory Committee on such a positive vote when men are out of options, delaying approval and asking for more trials," according to CareToLive spokesman Mike Kearny in an August 2, 2007, press release.

"Men are dying now," he states. "They do not have years to wait."

In the case of Provenge's approval, the profits at stake could not be higher. Prostate cancer is the most common non-skin cancer in the US and the third most common cancer worldwide. More than one million men in the US have prostate cancer, with an estimated 232,000 new cases diagnosed each year and more than 30,000 men face death from the disease each year.

As an initial treatment, when diagnosed with prostate cancer, most men have their prostate removed, or undergo radiation, which can lead to various degrees of incontinence and impotence. After the initial treatments fails, hormone therapy is given to block the production of androgens such as testosterone, needed for cancer cells to grow, and some men undergo testicle removal in an attempt to stop the androgens from spreading the cancer.

With AIPC patients, prostate cancer has usually gone into remission and then returned, spreading to other parts of the body including the bones, lymph nodes, bladder, rectum, liver and lungs. All men who do not die of other causes progress to the final stage where the cells no longer respond to hormone therapy. Provenge is intended for use by patients who have already failed other types of therapy.

Because Taxotere is the only approved drug, Sanofi would have suffered the greatest immediate loss had Provenge been approved. According to firm's 2006 Annual Report, Taxotere was the company's 4th best-selling product in 2006, and the US is listed as the number one country contributing to sales.

As far as profits per dose, in the February 7, 2007, article, "What Does It Cost to Have Cancer?", a patient who received the chemo drug for breast cancer in 2006 reported that "each infusion of Taxotere cost over $16,000."

She also stated: "That's just for the drug, not administration or anything."

According to the lawsuit, defendant Dr Scher, Chief Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, is a scientific advisor and lead trial investigator for a competitor of Dendreon called Novacea. Under faculty disclosures at the University of Michigan, Dr Hussain is listed as an advisory board member of Novacea, and she receives research funding from Sanofi.

Dr Scher also has an interest in ProQuest Investments, which stood to reap windfall profits if Provenge was not approved. ProQuest is a venture capital fund established in 1998, in large part by Michael Milken, who was given the nickname "Junk Bond King," after being indicted on nearly 100 counts of insider trading and sentenced to 10 years in prison, in addition to being barred from the securities industry for life.

The ProQuest fund was established with a specific focus on prostate cancer, and SEC filings show that ProQuest and its principals are major shareholders of Novacea.

Citing documents from ProQuest, the plaintiffs allege that Dr Scher is a "ProQuest Executive" and "member of the Board of Directors", ProQuest reaps millions of dollars investing in prostate cancer companies based on advice from doctors such as Dr Scher, and ProQuest own stock in direct competitors including Novacea.

Dr Scher receives compensation from ProQuest as a scientific advisor recommending investments and for conducting clinical trials that result from the investments. He also holds an ownership interest in ProQuest.

The lawsuit also alleges that Dr Scher receives research support from the Prostate Cancer Foundation, as well as financial benefits, as one of a consortium of members who reviews new research on cancer drugs to determine which grants should be awarded by the Foundation.

The PCF, also founded by Mr Milken, is one of the largest sources of funding for the National Cancer Institute and government research programs. A following of the tangled web involved in the PCF reveals that Dr Jonathan Simons, President of the Foundation, Dr Stuart Holden, Medical Director, and Dr Howard Soule, an Executive Vice President of the Foundation, are all scientific advisors to ProQuest.

Another research arm found to be infested with several of the same insiders is the Prostrate Cancer Research Program, within the Department of Defense, which since 1997 has been appropriated a total of $730 million by Congress. According to a PCRP report, "Today, the PCRP is the second leading source of extramural prostate cancer research funding in the United States."

The PCRP funds a Clinical Consortium Award to support the creation of a major multi-institutional clinical trial resource, "to speed development of novel therapeutics that will ultimately decrease the impact of the disease."

Here, too, Dr Scher is listed as the leader of the consortium, and the list of participating clinical sites and lead investigators includes none other than Dr Hussain. Dr Simons is listed as developing new clinical therapeutics for late-stage prostate cancer, but a review of upcoming research listed in the report shows immunotherapies are not in the cards.

These consortium members are invaluable to the industry and investors due to their unique access to insider information about clinical trials and influence over the FDA approval process. Evidence of this claim came on May 30, 2007, less than 3 weeks after approval for Provenge was denied, when Novacea announced an agreement with Schering-Plough worth over $450 million, in which Schering agreed to jointly fund and develop Asentar, a competing prostate cancer drug, for which Dr Scher happens to be the lead investigator.

"The partnership leverages Novacea's existing capabilities with Schering-Plough's experienced development, regulatory and commercial teams and will provide Novacea with an opportunity to support the commercialization of Asentar in the United States," John Walker, company chairman and interim CEO, stated in a May 30, 2007 press release.

A May 2000 ProQuest document provides insight about the investment firm's interest in Asentar's success and states: "ProQuest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin."

Mr Moorin owned 1,910,988 shares of Novacea stock at the time of a May 15, 2006, SEC filing, and the ProQuest document mentions an investment from Domain Associates, "whose general partner, Jim Blair, has also worked with the fund to plot its strategy."

As it turns out, Mr Blair and Mr Moorin were both members of Novacea's board of directors when the Schering deal was set up. However, apparently their services are no longer needed, because on August 30, 2007, Novacea announced the resignation of James Blair and Jay Moorin, effective September 4, 2007, and September 19, 2007, respectively.

All that said, it does not take a financial genius to figure out that this whole deal could have gone up in smoke had Provenge been approved, because there would have been a drastic drop in the enrollment of late-stage cancer patients in clinical trials as soon as they learned that there was a new vaccine that could not only increase their survival rate but allow them to live out their final days without the agonizing side effects of chemotherapy.

Provenge's approval also would have caused many patients currently participating in trials to drop out. Novacea's 2006 Annual Report filed on April 2, 2007, less than 2 months before the Shering announcement, warned that the "clinical development and regulatory approval processes inherently contain significant risks and uncertainties."

The report shows Novacea was going broke trying to keep the Asentar trials running, with research and development expenses associated with the drug of $12.9 million for the year ended December 31, 2006, up from $7.3 million for the year ended December 31, 2005.

The $5.6 million increase was due primarily to the Phase 3 Asentar trial, and the filing warns that Novacea could experience many delays in getting its product to market due to problems in trials including, "patient enrollment may be slower than expected at trial sites due to factors including the limited number of, and substantial competition for, suitable patients with the particular types of cancer required for enrollment in our clinical trials".

It also notes that there "is a limited number of, and substantial competition for, suitable sites to conduct our clinical trials; clinical trial sites may terminate our clinical trials"; "patients and medical investigators may be unwilling or unable to follow our clinical trial protocols;" and "patients may fail to complete our clinical trials once enrolled."

In addition, another ongoing trial is evaluating Asentar as part of a combination therapy for AIPC patients with Sanofi's Taxotere. If safety or efficacy issues arise with Taxotere, the annual report warns, Novacea could experience significant regulatory delays, and the clinical trial may need to be terminated or redesigned.

Even if Asentar were to receive FDA approval, Novacea would continue to be subject to the risks that could arise with Taxotere or that Taxotere may be replaced as the standard of care for AIPC. "This could result in Asentar ™ being removed from the market or being less commercially successful," the report states.

Ironically, in one of 3 derogatory letters sent to the FDA urging the non-approval of Provenge leaked to the media following the failed efforts to rig the advisory panel vote, Dr Scher discussed the same fatal effects that the approval could have on the research industry. "An approval recommendation has far reaching implications beyond making the product available that the data simply do not support or justify," he wrote.

Approval would provide the Agency's endorsement of Provenge as a "standard of care" for men with AICP, he said, and by extension, elevate Provenge "to a position of being the new 'control' arm for future randomized phase 3 trials that are being designed for the regulatory approval of any new experimental agent or approach."

In other words, all the billions of dollars invested in the clinical trials now underway, or set to begin, conducted in hopes of gaining FDA approval for a new ACIP treatment, could go right down the drain if Provenge is approved as the first-line treatment for this patient population.

Dr Scher is probably more aware of this fact than anybody. On February 26, 2007, MedPage Today reported that in a satellite symposium titled, "Improving Upon Current Standards: The Integration of Novel Therapies in the Treatment of Androgen-Independent Prostate Cancer," sponsored by Novacea, Dr Scher said Taxotere-based combination therapy is being investigated in a dozen clinical trials for ACIP patients, and he reported receiving grants and research support from both Novacea and Sanofi.

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A great letter to Hon. Senator Charles (Chuck) Grassley regarding Howard Scher's letter:

http://www.investorvillage.com/smbd.asp?mb=971&mn=161222&pt=msg&mid=3300906

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On Michael Milken:

http://www1.investorvillage.com/smbd.asp?mb=971&mn=172822&pt=msg&mid=3765225

Michael Milken and the Prostate Cancer Foundation’s Foul Balls:

Picture of Michael Milken and Andy Von Eschenbach and Picture of Mike Milken & Howard Scher:

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Good article in Nature about the crooked elements working to delay a life extending safe agent from reaching terminal patients: http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-1.html

Quoting from the article: "At least one of the Office of Cellular, Tissue and Gene Therapies Advisory Committee members who voted against Provenge and then wrote to FDA to criticize the approval recommendation—Howard Scher of Memorial Sloan-Kettering Cancer Center—failed to disclose important competing financial interests. Scher is a scientific advisory board member of venture capital firm ProQuest, which owns an 8.3% stake in Novacea, a company that was developing a competing prostate cancer drug, Asentar. Scher also happens to be the lead investigator in Asentar trials."

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Kerry M. Donahue, the trial attorney for defendants, representing some prostate cancer patients, etc. is an angel.

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interesting post on an alleged panic meeting to help shoot down the approval of a safe effective agent for dying men :

http://www.investorvillage.com/smbd.asp?mb=971&mn=170174&pt=msg&mid=3682238

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Jonathan Aschoff of Brean Murray is a class act. He is a security analyst who impersonated doctor in order to get confidential information. I came across this web page which is quite funny (and sad). He was fined by the NASD.

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This is one heck of a post. I do not know if all the allegations are true but IF they are true, they unfold a core of evil at the FDA and shows how power play can mean money, and lost lives.

Pazdurs fun house.....or Pazdurs house of horrors for the patients - Pazdurs playhouse.....or Pazdurs house of horrors for patients

http://www.investorvillage.com/smbd.asp?mb=971&mn=163536&pt=msg&mid=3426907

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Richard Pazdur of FDA was another problematic person whom many believed was compromised.

Here's from a filing in a lawsuit against Scher and Pazdur by patient advocacy group: Care To Live.

Now comes Plaintiffs and hereby offers the following memorandum contra the individual Defendant’s motion to dismiss. Plaintiff has set forth causes of action against Howard Scher and Richard Pazdur in their individual capacities as government employees and as individuals who exceeded the scope if their employment by unlawfully and purposely sabotaging a proven safe and effective treatment for AIPC prostate cancer sufferers, resulting in the denial of that treatment to patients who were and are hoping to receive it and to their doctors that wish to prescribe it.

Richard Pazdur lobbied for all immunotherapies to come through his CDER controlled AC panels, which were controlled by his OOD division. He lost. He then wanted his controlled CDER panels to be the ones to advise the FDA regarding Provenge. He lost. Richard Pazdur then fought for the right to place two of his CDER panelists on the CBER Advisory Committee. He won. Then he found two severely conflicted oncologists who he knew would be willing to follow his instructions because they had everything to gain and nothing to lose by the non approval of Provenge. The two Oncologists he hand picked and placed on the AC were Dr. Maha Hussain and Dr. Howard Scher. These oncologists had both disclosed and undisclosed conflicts of interest and Dr. Pazdur knew they would be receptive to his request to help him to derail Provenge, in that they both would personally benefit by the non-approval of Provenge.

Dr. Pazdur then pressured other AC panel members to vote against the approval of Provenge. Although Pazdur had no business even being at the Provenge AC hearing he attended anyway in hopes that his mere presence would sway Committee votes. Commissioner Dr. von Eschenbach did not attend. Dr. Pazdur then spoon fed ideas to Committee members Maha Hussain and Howard Scher during breaks in the AC meeting, even passing hand written notes to Dr. Hussain, presumably to assist her in making arguments attacking Provenge.

Prior to the AC meeting, Pazdur, Scher and Hussain had discussed the plan and all were aware that Pazdur had altered the key question that was to be voted on by the panel of experts to reflect a standard that was higher than the congressionally approved standard. Pazdur tried to raise the bar in an effort to obtain a “no" vote. The question was changed by Pazdur to “has efficacy been established". The votes started to come in as “no’s" but CTGT head Celia Witten and CBER head Jesse Goodman realized the question had been changed to one that asked for a standard higher than that set forth by regulation as decided by Congress. The question was then restated to the congressionally mandated requirement “is there substantial evidence of efficacy". The AC panel responded “yes" by a vote of 13-4. Two of the 4 “no" votes were Dr. Hussain and Dr. Scher. One of the other two “no" votes was the statistician who determined that the FDA guidelines suggested that there was a one (1) in forty (40) chance that the survival data was obtained by mere chance (the FDA statisticians generally like there to be only a one in 1600 chance that the results are by chance). Dying cancer patients do not care if a safe immunotherapy has a 1 in 40 chance of not helping them. They correctly focus on the 39/40 chance it will help them. That Scher and Hussain had a pre hearing agenda is easily demonstrable by the AC transcript itself, which also makes it obvious that they had been tipped off and ready for the “loaded" question. They were both confused about how to respond when the question was properly fixed and then elected to just answer the first wrongly phrased question. Mrs. Hussain took the route that she was going to consider “establish" and “substantial" to be the same standard (this was the perverted way she had to justify in her mind a “no" answer to the substantial evidence of efficacy question because otherwise she knew this was wrong as she knew that there absolutely was substantial evidence of efficacy demonstrated). Mr. Scher actually said no to the first question and yes to the second indicating that he believed if the question was asked as congressionally mandated to be asked then Scher was in fact admitting that the correct answer to the question whether there was substantial evidence of efficacy was YES. In reality even both Dr. Scher and Dr. Hussain can’t deny that Provenge is both safe and shows substantial evidence it is effective. Note: the fourth “no" vote came from Dr. Richard Chappell who also chose to ignore the fact the question was properly restated and chose to answer the first question instead (he seemed confused about what question he was answering). This is all clearly demonstrated on the AC hearing transcript.

When the pressure exerted on the panel by Richard Pazdur did not work and when the efforts of Scher and Hussain to sway the panel did not work, and when their “change the question trick" did not work, Richard Pazdur, who had no business being at or involved in the Advisory Committee meeting to begin with, decided that in order to implement his vow that no immunotherapy that did not come through OOD would ever be approved, he needed to take more extreme measures. He then encouraged Dr. Hussain, Dr. Scher, and a known cohort of his, Dr. Richard Fleming to write letters to Janet Woodcock, Jesse Goodman and Commissioner Dr. von Eschenbach, in order to lobby them further to delay and/or deny the pending Provenge approval.

Richard Pazdur, along with help from FDA employees and other employees of the NCI division of HHS, including but not limited to Alison Martin, concocted a plan to send three letters to be signed by Scher, Hussain and Fleming, and which were written and purportedly sent to Dr. Woodcock, Dr. Goodman and Dr. von Eschenbach. Richard Pazdur’s post AC plan to derail the expected Provenge approval was discussed at a meeting wherein both NCI employees and OOD were present. Present at that meeting was another NCI employee, who Plaintiff will not name at this time. At this point NCI employees directed by FDA employee and OOD head Richard Pazdur, helped the three doctors write their letters with the designed goal of derailing Provenge approval. Then, Richard Pazdur, conspiring with other HHS employees, and conspiring with Scher, Hussain, and Fleming, purposefully “leaked" a copy of each of the letters, on different dates, to a non peer reviewed journal called The Cancer Letter (perhaps not coincidentally the very same non peer reviewed journal that Pazdur “leaked" the Imclone/Erbitux information to) which journal published all three letters. Investment funds, hedge funds, analysts and others who were short the stock and who had inside information from FDA employees then “piled on", contributing to CBER’s pressure which was now being felt by CBER from both within and outside the FDA. First CBER was bullied by Pazdur prior to the AC, then CBER was pressured by Pazdur, Scher and Hussain during the AC, and then CBER was pressured by letters written by Scher, Hussain and Fleming, with the help of Pazdur and other taxpayer paid government employees after the AC. Then more pressure from Pazdur himself and then CBER was pressured by actions of NCI and finally was pressured by way of the outside pressure that came as a result of the “leaked letters".

The sordid actions did not end here. CBER was still set to go ahead and approve Provenge anyway. However, Richard Pazdur had one final trick up his sleeve. Richard Pazdur then threatened that a public demonstration would be carried out by his CDER division, to again take the issue outside the FDA (having done that already with the “leaked" cancer letters which paved the way by bringing the argument to the outside world). The threat was to take the FDA’s dirty laundry and political infighting outside the FDA. This final unlawful action by Richard Pazdur succeeded in persuading CBER to finally cave in and issue a non-approval letter rather then the approval letter they were preparing to send to the applicant (Dendreon). The CR letter was unusually convoluted and hard for even the applicant to understand (requiring weeks to interpret along with a translation from the FDA, to fully decipher). It appeared to have been written as a conditional approval letter which was hurriedly changed into a non-approval CR letter.

Defendant Howard Scher disclosed several conflicts on his conflict of interest waiver request form which he was required to file with the FDA in order to be eligible to serve on the Advisory Committee. Although it was mandatory to disclose all his conflicts he did not do so. He had many undisclosed conflicts. The total number of conflicts is believed to be 16 or 17. Defendant Scher did not tell the FDA that he was the lead investigator for Asentar the Novacea late stage prostate cancer treatment or that there was a pending deal on the table to sell an interest in Novacea to Schering Plough for 440 million dollars. The deal between Novacea and Schering Plough was announced a few weeks after the non approval of Provenge. He did disclose to the FDA that the 440 million dollar deal between Novacea and Schering Plough would not go through if Provenge was approved. Not only was Scher the lead investigator for Asentar but as a Scientific Advisor, Director and a top Executive for ProQuest Investments, he stood to profit from the Novacea deal. Proquest Investments owned a significant number of shares in Novacea at the time Scher sought to derail the Provenge approval. Scher had at least 16 other conflicts of interest that made him inherently biased, and should have disqualified him from sitting on and voting during the AC. He was in a position to profit financially, politically and historically by the non-approval of Provenge on May 8^th, including securing his place as the lead doctor in other prostate cancer trials competing with Provenge and hoping to be “first to market", a coveted position. There also was concern by the NCI and Scher that the approval of Provenge would make it harder to recruit prostate cancer patients for pc trials including the pending taxotere trial enrollments, as it would set a new standard to compete against without all the toxic side effects.

Mr. Scher was a special government employee (SGE). His role was to serve as an advisor to the FDA, in this instance the CBER division, as a panelist on the Advisory Committee. This was an open hearing wherein there was a record (transcript), and any real (as opposed to imaginary) concerns could be discussed with the other advisors and with FDA staff. At the close of the AC his role as government employee was finished. At that point further conspiring with Richard Pazdur, Alison Martin and others was outside the scope of employment.

The “leaked" letter signed by Scher which was written with the help of HHS employees is full of disingenuous and inaccurate assertions that were not even believed by him. A glimpse of version 3 alone, that is attached hereto (Exhibit A), demonstrates the goal of finding a possible reason to argue for non-approval. This version 3 draft sought opinions and other help in justifying Scher’s position which he had already taken at the AC. In addition, the “leaked" draft and final letter contained contradictions to Scher’s position at the AC where he voted Provenge safe, rendering the safety vote unanimous. Now in his “leaked" letter he contradicts himself from just a few days earlier and questions the safety of Provenge. The inconsistencies of Defendant Scher are pointed out in “Appendix one" and “Appendix two", attached hereto. Appendix one, is an analysis of Scher’s letter by Biotech Research Expert David Miller and Appendix two is a letter with analysis by a group of twelve (12) doctors and four (4) research scientists that were both written soon after Scher’s leaked letter appeared. Since the writers did not have the same access to the authorities as did Howard Scher it is unknown if anyone with any decision making authority at the agency ever considered it, at this stage of the proceedings.

These actions by Scher were taken by him at the urging of others including Pazdur. Not even Scher, himself, believed what was written in the letter he signed, that helped to derail Provenge. Mr. Scher wrote the letter with the help of HHS employees and at the urging of Pazdur with the intention that the letters be sent to Dr. von Eschenbach, Janet Woodcock and Jesse Goodman and also that they be “leaked" to the press with full knowledge that they were going to be used to persuade CBER not to approve Provenge. He even castigated CBER in the process. As set forth by Scher himself CBER is a bit weaker and more likely to be influenced or manipulated by others then CDER. The post AC actions of Defendant Scher were outside the scope of his employment as a special government employee as the scope of his employment was to advise the FDA during the AC meeting. Once the AC meeting was over his role was completed. There is not supposed to be a second hearing in some back room outside the view of the public with selected biased participants to promote their own agenda. It was not his role to use his special government employee status to conduct a post AC lobbying effort via a letter to CBER, CDER, the Commissioner and the press to deny an applicant’s BLA. Question: Why was he fighting so hard for non approval? Answer: Because he personally benefited by it. None of the other 13 doctors who did not have conflicts and voted that there was substantial evidence of efficacy wrote any post AC letters. Only the two severely conflicted “no" voters who were unable through their other chicanery to derail Provenge prior to and at the AC, wrote post AC letters (as did non-panelist Dr. Fleming who is a known cohort of Richard Pazdur).

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