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. 

~~~

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).

~~~

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.”

~~~

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.

~~~

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

~~~

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:

~~~

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."

~~~

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

~~~

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

~~~ 

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.

~~~

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

~~~

PROVENGE

WAS FDA REVIEW OR PROVENGE A CORRUPTED PROCESS BY CONFLICT OF INTEREST?

In 2007, an 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 and details can be found here: http://caretolive.com/LawsuitLinks.html

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

The following story is the best account of this horrible misery that the a bunch of suckers orchestrated against life, against goodness, against ethics, and all that stands for decency, in favor of money. It is a sad account of how money has become the new God in the minds of some people.

__________________________________________________________ .

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.”

____________________________________________________________________________________________________________________

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

____________________________________________________________________________________________________________________

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.

http://aschoff.blogspot.com/2007/04/jonathan-aschoff-from-brean-murray-hes.html

____________________________________________________________________________________________________________________

Very  interesting discussion about Drs. Maha Hussain and Howard Scher, conflict of interest, chemotherapy vs. immunotherapy, etc.:

http://caretolive.com/CTLfinalvsPazScher.pdf

Here is the html version: CTLfinalversion17mocontradismiss.html

____________________________________________________________________________________________________________________

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 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

____________________________________________________________________________________________________________________

This is an extremely interesting reading:

PLAINTIFF’S SUPPLEMENTAL MEMORANDUM IN SUPPORT OF MEMORANDUM IN OPPOSITION DEFENDANT’S MOTION TO DISMISS AND AS SUPPLEMENT TO MOTION FOR INJUNCTIVE RELIEF

9nov_provenge.pdf

____________________________________________________________________________________________________________________

 http://www.investorvillage.com/smbd.asp?mb=971&mn=161294&pt=msg&mid=3305795

CTL Lawsuit Reflections

After reading the better part of Kerry's unbelievable legal work I am left with the following basic questions that I hope the Judge will carefully consider prior to making his decision in the CTL case.

How often is the head of CDER present at a CBER AC meeting?

How often is the Substantial Efficacy question miss-worded at AC Meetings?

How often are such conflicted AC panelists permitted to attend AC's & vote?

How often are letters leaked post AC to influence an FDA decision?

How often has the FDA overruled a positive AC vote for a late stage disease?

How often does the SI in a stock increase markedly after considering the above?

How often has the media been so negative after considering the above?

Obviously, there are many other questions that can be added to the list (i.e. Von E's speeches for one). My point and opinion is that the more oddities/irregularities that are introduced to the list the more clear it becomes how unbelievably jaded and corrupt the Provenge travesty was. Of course none of this information is new to anyone here; I just pray that the Judge lets his eyes be opened as wide as ours have.

One very big thank you to Kerry and all the other incredibly selfless people here that have given so much! IMHO you will all take up a bigger chapter in history than is readily apparent today.

____________________________________________________________________________________________________________________

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

____________________________________________________________________________________________________________________

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:

http://caretolive.com/2007-11-18/michael-milken-and-the-prostate-cancer-foundations-foul-balls/

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

http://www.prostatecancerfoundation.org/site/c.itIWK2OSG/b.734793/k.3E28/Photos_from_the_2005_Home_Run_Challenge_to_support_the_Prostate_Cancer_Foundation.htm

____________________________________________________________________________________________________________________

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."

____________________________________________________________________________________________________________________

Here's an interesting post about Howard Scher, Maha Hussain, etc.

http://www.investorvillage.com/smbd.asp?mb=971&mn=177793&pt=msg&mid=3961558

http://www.investorvillage.com/smbd.asp?mb=971&mn=181520&pt=msg&mid=4103477

5 reasons the E&C should conduct the investigation

____________________________________________________________________________________________________________________

A post by KDDublin (reprinted with permission): http://www.investorvillage.com/smbd.asp?mb=971&mn=199222&pt=msg&mid=4876203 Hey, hey FDA, ain’t no way were ever going to go away.

Trust me when I tell you, that not only does the FDA monitor this site, but so does their counsel.

Here is an open letter:

Listen up FDA. We are never, ever, going to go away!!!

Tomorrow is merely one day. ONE DAY!! It is merely the first day in the rest of your lives!!

While I am confident that Andy’s days are numbered for his complete incompetence in running the FDA, you other career bureaucrats, Pazdur, Woodcock and Goodman, need to know that we will be here for you every step of the rest of your pathetic careers. You get to look forward to our presence for many years to come!

This grass roots movement has just begun. We are just now starting the fight. We grow stronger by the week. The CareToLive web site has thousands of new and unique visitors to its site every week. The word is spreading fast now and you can’t stop it anymore. Once the world knows of your misdeeds you will no longer be able to hide amongst your fellow corrupt brethren.

While you and your big pharma buddies laugh and giggle and plot against little biotech companies like Dendreon, so you can maintain your big bucks status quo, and seek to climb you career ladders and grab what power you think you can, those who are trying hard to make Cancer a treatable condition rather than a deadly disease, will expose those Andy bullshit “bridge not a barrier” speeches that he makes in the name of politics for the benefits of Congress, and the real advocates fighting on the front lines of the war on cancer will continue to fight the number one barrier to winning that war,…...THE CORRUPT FDA!!!!!!!!!

Tomorrow it is Coast to Coast demonstrations and that will be a nice start. But you need to understand it is merely A START! Next we are coming to MLB ballparks throughout the country, and then to back to Rockville, and this time there won’t be two hundred people in Rockville, there will be two thousand!

Men are dying while Woodcock, Pazdur and the FDA are wined and dined by big pharma. Men are dying while Scher lines his pockets at the expense of the patients he is sworn to protect. Men are dying while your friends profit. NO MORE!!!!!

Stand up 2 cancer. You bet we will. Those at CareToLive know where the front lines are and we will keep reinforcing those lines until we defeat cancer and the enemy that stands in the way of the patient’s ability to win that war, which those with knowledge know to be YOU!!!!!

____________________________________________________________________________________________________________________

Words of Howard Scher at the panel meeting. Makes you really wonder if this jackass is in the pocket of Big Pharma and/or hedge funds who had a lot to lose on Provenge's approval? Only ones who lost were dying cancer patients who were denied a life extending safe biologic agent.

---

Does anyone remember Dr. Scher's answer to the 2nd question? Here is is...

I wonder what he meant? About what was he concerned? Hmmmmmmmm...what could possibly be on his mind?  Asentar?  Naw!

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.

Original Content at http://www.opednews.com/articles/genera_evelyn_p_080108_bush_s_fda___perpetu.htm

Reprinted with permission

January 8, 2008

Bush's FDA - Perpetual Leaker of Insider Information

By Evelyn Pringle

Bush's FDA - Perpetual Leaker of Insider Information

The steady leaking of insider information about products under review by the FDA has caused enormous losses for average American investors since the Bush Administration took control of the agency six years ago.

There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.

But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.

When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss.

One high-ranking member of the Bush Administration's FDA, Dr Richard Pazdur, has been one of the leakers in two cases involving cancer drugs that caused investors to lose vast amounts of money.

The first case devastated investors when a company's stock value dropped more than $1.5 billion in less than 3 weeks after Dr Pazdur tipped off the Cancer Leadership Council's legal counsel Samuel Turner that the FDA planned to reject the application for approval of a cancer drug the week before the decision was scheduled to be sent to the main sponsor, ImClone, on December 28, 2001.

At that time, Mr Turner also was a registered lobbyist for a number of pharmaceutical companies, including Bristol-Myers Squibb, which just happens to be the largest manufacturer of chemotherapeutic drugs.

Bristol-Meyer tipped off ImClone owners Harlan and Sam Waxal, and family members immediately started selling their stock. An investigation by the SEC later determined that the Waksals sold more than $10 million worth of stock in the 48 hours before the FDA's rejection of the application for drug was made public.

According to a June 16, 2002 report on Newsbytes News Network, short sellers also made millions by placing bets that ImClone's stock value would fall in the weeks before the FDA publicly rejected the application.

The House Committee on Energy and Commerce investigated the insider trading in this case, and a subcommittee held a hearing on June 13, 2002. At the start, the chairman noted that there were two stories here.

One, he said, "will be more fully told by the SEC and the Justice Department as it examines how the FDA process and what appears to be some rather amoristic players conspired in a way that allowed insider trading to potentially occur and an awful lot of investors to lose a lot of money while insiders were trading on information that was available only to them."

"The other story," he noted, "is about the process at FDA and how the FDA process allowed this to happen."

A transcript of the hearings shows that when members of Congress asked directly who within the FDA leaked the information to Bristol-Myers, Dr Pazdur and the rest of the Bush Administration officials talked in circles and never answered.

But in the end, somebody pulled some strings because Dr Pazdur got off Scott free, which probably accounts for his lack of fear when engaging in similar, behind-the-scenes activities in 2007.

In the more recent case, the continued short selling in Dendreon's stock following the Provenge Advisory Committee meeting of March 29, 2006, despite the fact that the Committee recommended approval of the drug, surely indicates that information leaked to Wall Street from inside the FDA guaranteed that the drug would not be approved.

On May 9, 2007, when Dendreon announced to the public that the FDA had issued the company a Complete Response Letter instead of an approval letter, the market value of Dendreon dropped more than 60% in one day.

The known people behind the "leaks" in this case are Dr Pazdur, along 2 members of the Advisory Committee who were chosen to participate on the panel by Dr Pazdur. When persons serve on these committees, they become "special government employees," and are subject to the same rules and regulations as all government employees.

When the Provenge Committee recommended approval, there were two votes taken. The first was on safety and the vote was 17-0 that the drug was safe. The second was on efficacy and the vote was 13-4 that the drug demonstrated "substantial evidence" of efficacy, the federally mandated standard.

The approval of this new cancer vaccine represented a grave threat to the multi-billion dollar chemotherapy industry. Dendreon is the first company to seek approval of a drug in a promising new class of immunotherapies that direct the body's own immune system to attack only cancer cells, unlike chemotherapy which destroys cancer cells but damages healthy cells and the immune system as well.

Provenge sought approval to treat men in the final stage of prostate cancer whose only option is months of chemotherapy with the drug Taxotere, which causes debilitating side effects and extends life on average 2.5 months.

In applying for approval, Dendreon submitted a study that showed 3 injections of Provenge extended life by nearly double that chemotherapy and the side effects, if any, consisted of flu-like symptoms for one or 2 days.

If the new immunotherapies turn out to be as effective as some experts claim, chemotherapy and radiation treatments could become obsolete in the not to distant future. Dr Pazdur knew this all too well. In fact, his fear was that if Provenge were to be approved, it would establish a new standard of care for late stage prostate cancer patients and from then on testing of new therapies would be up against Provenge.

He was also ticked off about the fact that the FDA had chosen the Center for Biologics Evaluation and Research to control the Provenge Advisory Committee instead of the Center for Drug Evaluation and Research, which he controlled.

So as a back-door means of regaining control, he recruited his two partners in crime, Dr Howard Scher, from the Memorial Sloan-Kettering Cancer Center, and Dr Maha Hussain, from Michigan University, to serve on the Advisory Committee to assist him in thwarting Dendreon's bid for the approval of Provenge.

Both of these doctors have made a fortune from their involvement in the cancer treatment and research racket over the past 2 decades. And they also stood to lose a fortune if the chemo-cartel was dismantled.

Investors had every reason to believe that Provenge would be approved once the Advisory Committee voted for approval. The FDA had never refused to follow a recommendation by its own experts to approve a drug for dying cancer patients who had no other options.

While testifying at the hearing, Dr David Penson, Associate Professor of Urology and Preventative Medicine at the University of Southern California, told the panel: "If you turn this drug down, it will likely set back the innovative field of active cellular immunotherapy in cancer many, many years."

He warned that the Committee's decision "will not only affect prostate cancer patients, but it may have an effect on the larger population of oncology patients in general."

Dr Hussain and Dr Scher were positioned on the panel to do everything in their power to make sure the vaccine was not approved. But their best efforts failed and within two weeks after the panel voted to approve the Provenge, Dendreon stock had nearly tripled in value and analysts were predicting that the vaccine could bring in $1 billion annually.

However, it was soon obvious that something was up, because the short sellers were still betting millions that the stock value would fall. On April 29, 2007, Bloomberg reported that shares were being sold short "at a record pace" as investors "bet the company's experimental prostate-cancer drug will fail to win approval from U.S. regulators."

All totalled, 33.9 million shares were sold short by the end of April. In hindsight, figuring out why people would engage in such risky betting was a no-brainer. The only people who could have known that Dendreon stock was headed for a nose-dive on May 9, 2007, because the FDA was going to overrule it's own panel by denying the approval of a cancer drug for dying patients for the first time in history, were the people who made it happen.

As late as May 7, 2007, Prohost Biotechnology, a firm that evaluates companies and publishes a monthly newsletter for investors, was calling Dendreon a good investment on its web site, stating: We Have A New Pick "DENDERON AGAIN."

The web site went on to explain why the firm was predicting that the short sellers were wrong in betting against the company, by stating in part:

This time, positive investors/analysts are determined to neutralize the shorters' efforts. Why not, if the verdict is expected in 10 days only and the committee, which was appointed by the FDA itself has already voted 17-0 in favor of safety and 13-4 in favor of efficacy?

We are with the approval, Prohost said. "As a matter of fact, we expect it on May 15, based on many facts, the most important is the result of the FDA committee's voting."

The firm noted that the experts on the panel would not have been chosen by the FDA if they were not highly regarded researchers, medical doctors, and academicians, and stated:

"If the results of voting would have been 50-50, we would have understood the need for the FDA to take a stand. But with a landslide voting in favor of approval, we do not see why the FDA should hesitate to follow the committee's recommendation of approval.

"Besides, the vaccine is safe. It acts synergistically with the available treatments and it helped desperate patients survive advanced prostate cancer."

But as it turns out, another plot was put in action immediately after the news came out that the panel recommended approval, in which government officials at the FDA and the National Cancer Institute worked with Dr Scher, and probably Dr Hussain, to compose letters with bogus reasons why the FDA should not follow the recommendation.

Once the rough drafts were edited, the letters were sent to the FDA by email and hardcopy, and leaked for publication on the internet by "The Cancer Letter," which just happens to be the same rag used to leak insider information in the ImClone case.

The overly dramatic Dr Scher, even went so far as to tell Thomas Fleming, another doctor who just happened to send a letter to the FDA, disparaging Provenge, which was also put out on the internet by "The Cancer Letter," that he could not sleep because he was so concerned over the possibility of patients being harmed if Provenge was approved and that's why he wrote the letter. Dr Fleming then noted that he could not sleep either.

This is an utterly ridiculous remark coming from Dr Scher, considering that he and Dr Hussain voted with the majority 17-0 that Provenge was safe at the hearing.

The pharmaceutical companies that stood to benefit the most from the non-approval of Provenge were Novacea, Schering-Plough and Sanofi-Aventis because they have billions of dollars invested in research, drug trials, and cancer treatments involving therapies that would compete directly with Provenge for the same late stage prostate cancer patients.

Dr Scher and Dr Hussain, as well as her husband, are involved in dozens of studies conducted by the same companies. Both Dr Scher and Dr Hussain are consultants and members of the scientific advisory board for Novacea, which produces Asentar together with Schering-Plough.

Asentar would directly compete with Provenge and at the time of the Advisory Committee hearing, Dr Scher was the co-lead investigator on trials of Asentar

According to www.portfolio.com, Dr Scher is also an officer, member of the Board of Directors, and a member of the Scientific Advisory Board of ProQuest Investments, which was had mega-bucks invested in Novacea during 2007. However, for some odd reason, ProQuest's web site no longer lists the names for the Scientific Advisory Board.

Dr Scher and Dr Hussain have also both received research funding from Sanofi-Aventis the maker of Taxotere.

A review of Dr Hussain's most current resume in fact, shows that she's been on one long global junket funded by the cancer treatment and research racket for close to 2 decades. She apparently began her journey in Bagdad, Iraq, in1980, and 2 years later she was in the UK and a year after that she ended up in Detroit, Michigan.

It looks like her home base has been Ann Arbor, Michigan since late 2002, that is in between her 6 trips to Canada, 3 to Hawaii, 3 to Puerto Rico, 2 to St Thomas, 2 to Barcelona, and at least 1 trip to Japan, China, Jordon, Lisbon, Monte Carlo, Bermuda, and Austria, in addition to her 17 trips to California, 9 to Chicago, 4 to New Orleans, 5 to New York, 9 to Florida, and at least 38 trips to other states.

The list of excursions certainly demonstrates that the good doctor enjoyed quite a lot of travel on someone else's dime. In fact, her hotel fees alone would put a bonifide hooker to shame.

Its impossible to determine the amount of "research" funding funneled her way because the amount is redacted for half of the grants listed. But at a bare minimum, she had at least 28 million "current" reasons to sabotage the approval of Provenge.

Under "Current Grant Support," she lists 11 grants, although 5 have no amounts. But the total for the other 6 comes to over $28 million, and she will be receiving income from a few of these grants for several more years.

Dr Hussain also lists another 2 grants as submitted, with all information redacted. She lists 5 under "Active Research," all involving treatments for late stage prostate cancer, but not one includes the amount. No dates are listed for these 5 grants either, which makes it impossible to estimate how long she intends to profit from this research.

The doctor also lists 30 funding sources under "Past", but only 6 have amounts. The total for those 6 comes to more than $20 million, so it would probably be safe to say that if all amounts were to be listed, Dr Hussain had at least 100 million good reasons to derail the approval of Provenge.

All the plotting by persons benefiting from the non-approval of Provenge might have gone undetected if not for the non-profit advocacy group, Care-To-Live. The group filed a lawsuit in Federal court against officials in charge of the FDA, including Dr Pazdur and Dr Scher, seeking an injunction to overturn the FDA's decision and to make Provenge available immediately to extend the lives of dying prostate cancer patients.

By filing the lawsuit, the group was able to gain access to a lot of information and after reading much of it, one thing's for sure, the government officials involved in this sick plot will never be accused of wasting time on the clock worrying about dying cancer victims.

Another case of leaking occurred on March 1, 2006, when the FDA sent a letter to the Canadian investment firm, Infinium Capital, that said the agency would allow testing for a generic version of Vancocin, marketed by ViroPharma, to be conducted in a test tube.

Two weeks later, after allowing plenty of time for persons with the inside information to position themselves to make a killing in the stock market, Infinium issued a report on ViroPharma stating, "Generics . . . sooner than you think".

According to an SEC filing by ViroPharma, Infinium's report was the first public disclosure of the new testing standard and:

"ViroPharma itself had not previously heard that OGD had lowered its BE standard for Vancocin. Nor it would seem, except those to whom OGD had privately communicated, had anyone else."

ViroPharma's filing went on to note that Infinium's report stated:

"Our recent communications with the FDA regarding the approval process for a potential generic competitor to Vancocin lead us to believe a generic could enter the market 1-2 years sooner than current expectations."

What "recent communications with FDA" might mean, the filing states, beyond the March 1, 2006 letter to Infinium, is unclear to ViroPharma. On March 16, 2006, Medindia.com dropped a bombshell when it informed the public of the news by quoting analysts at Infinium as saying it could mean a generic version would be available by early 2008.

"Previously, generic manufacturers may not have been interested in developing this therapeutic due to its low revenue potential; however, with the recent sales growth of 133 percent in 2005, Vancocin is now on the radar screen," an Infinium analyst told Medindia.

Infinium's announcement caused shares of ViroPharma "to dip by about 33 percent," according to Medindia. But in fact, Infinium's report triggered a multi-day stock sell-off that cut the company's market capitalization by 40%, or roughly $500,000,000.

The approval process prior to the FDA's unexpected announcement required trials to be conducted on humans. ViroPharma has filed a Petition to stop the approval of generic versions with allegations that the FDA violated the Freedom of Information Act, the Data Quality Act, the Administrative Procedure Act, and its own Standards of Conduct.

Vancocin is used to treat hospital-acquired bacterial infections in the lower gastrointestinal tract caused by the bacterium Clostridium difficile. In order to be effective, the drug must be released in one specific section of the intestines, making its release mechanism far more difficult to replicate than other drugs.

The release of an ineffective version of Vancocin at this point in time would be especially dangerous because recent studies have shown that cases of Clostridium difficile-associated disease (CDAD) are increasing world-world. The disease causes 400,000 cases of diarrhea and colitis each year in the US, according to the US Department of Veterans Affairs.

In addition, a paper by Michel Warney, et al., entitled, "Toxin Production by an Emerging Strain of Clostridium difficile Associated with Outbreaks of Severe Disease in North America and Europe," in the September 2005 Lancet medical journal, reported a new strain of C difficile that produces up to 23 times more toxins than previous strains; this strain has been implicated as the cause of a more severe form of the disease

A May 11, 2007, report by the Pennsylvania Health Care Cost Containment Council said that in 2005, patients with CDAD were hospitalized 2-and-a-half times longer, charged over twice as much, and were 4 times as likely to die as patients without the disease.

On average, the report notes, patients with CDAD remain in the hospital almost 7 days longer at a cost of $73,576, verses the average charge of $30,833 for patients without the disease. A November 2007 report entitled, "The Emerging Infectious Challenge of Clostridium difficile-Associated Disease in Massachusetts Hospitals: Clinical and Economic Consequences," cites a "conservative estimate" of the annual cost for CDAD management in the US as $3.2 billion.

People treated with antibiotics are at the highest risk because antibiotics disrupt the balance of bacteria in the GI tract, which allows C difficile bacteria to multiply. CDAD is highly infectious and can spread by contact with patients or touching surfaces contaminated with C difficile spores. The severity of the disease ranges from mild cases of diarrhea to painful colitis, bloodstream infections or death.

Years ago, CDAD was almost exclusively limited to patients in hospital or long-term care settings where infectious diseases spread easily. But there are now widespread reports of patients developing CDAD outside hospital settings, referred to as "community-acquired" CDAD, and with no antibiotic exposure.

Recent studies indicate that many cases may be caused by proton pump inhibitor drugs which inhibit the production of gastric acid in the stomach that acts as a defense against bacteria and spores, widely used by persons with ulcers and other GI illnesses.

The December 21, 2005, Journal of American Medical Association published a report by Canadian researchers based on studies that determined that gastric acid-suppressant drugs were associated with the rising cases of community-acquired CDAD.

The researchers used the United Kingdom General Practice Research Database and identified all 1,672 cases of CDAD recorded between 1994 and 2004 and found that 1,233, or 74%, of the patients had not been hospitalized in the year prior to the diagnosis and were considered community-acquired.

The study showed the increase in community-acquired cases rose from less than 1 per 100,000 in 1994 to 22 per 100,000 in 2004 and during this same period, prescriptions for antibiotics had decreased while prescriptions for proton pump inhibitors had increased.

The first course of treatment for CDAD caused by antibiotics is to stop the antibiotics. But if diarrhea continues and becomes severe, Vancocin is a treatment of last resort for very sick patients which means there is no room for error.

The FDA claims that dissolution testing for the generic version can be done by creating a test tube solution that replicates the environment in the lower intestine. But experts say it would be next to impossible to replicate the GI tracts of very ill and elderly patients to determine whether the generic version will work the same in the targeted area.

Experts also point out that drug interactions, such as those in patients on proton pump inhibitors would make it hard to develop a solution that would replicate the GI tract.

The approval of an ineffective generic version of Vancocin, will subject millions of people to potentially fatal risks because the patients who end up being treated with this medication will have no second chances if it fails.

The FDA is currently under attack for doing the exact same thing by not requiring adequate testing for the generic version of the antidepressant Wellbutrin. The FDA approved the generic in 2006 and after a steady stream of patients reported that they were experiencing serious side effects, testing by ConsumerLabs, revealed that the time release rate of the active ingredient was much faster than the release rate in the original drug.

The consumer-product testing group, ConsumerLab began investigating the drug after Joe and Terry Graedon, authors of The People's Pharmacy column, came to the group with complaints received from readers of their column. While the Graedons had received complaints about generic drugs before, "we had never received this volume of response," Joe Graedon, a pharmacologist, told MSNBC on October 12, 2007.

"In almost all cases people were saying their depression returned," he said. Users also complained about severe headaches, digestive problems, insomnia, anxiety, and tremors.

ConsumerLab performed dissolution testing on 6 samples of each medication and found that even though both contained the same amount of the active ingredient, the generic released nearly 50% of the ingredient in the first 4 hours verses 25% by Wellbutrin.

"It's been an eye-opener for everyone," ConsumerLab President, Dr Tod Cooperman, told MSNBC. "It makes you question whether generics are always going to be equivalent to the original product."

"If these things are releasing at such different rates," he advised, "it's hard to believe they'd be acting the same way in your body."

"It would seem very difficult to imagine that the results we saw would be acceptable results," Dr Cooperman told MSNBC.

He pointed out that the release of the active ingredient more quickly could mean there is less medication available to the patient later, and may explain why patients experienced a return of their depression.

He said a time-release problem might also explain why patients experienced more side effects, such as headache, irritability and nausea, if they received a high dose of the medicine upfront. "Too much Wellbutrin can cause side effects, even the potential for seizure," he told MSNBC.

The Canadian firm Biovial filed a petition with the FDA in 2005, asking the agency to require generic makers to conduct more rigorous testing of generic versions of Wellbutrin prior to their approval but apparently the agency ignored the request.

An agency spokesperson told MSNBC that the FDA does not require generic makers to do clinical trials on hundreds or thousands of people as required for name brand drugs. It only requires lab data and "bioequivalence" testing in about 24 to 36 healthy volunteers showing that the drug enters the bloodstream in a similar manner to the original product.

Since the generic version was approved, millions of consumers have switched to the drug to save money which means a high number of patients may be experiencing serious side effects without knowledge of the cause. Experts say this whole problem could have been avoided had testing on humans been conducted to check the release mechanism before millions of scripts were written.

"Sustained release mechanisms are not that easy to develop, and they tend to be proprietary in nature," Michael Katz, clinical associate professor of pharmacy practice and science at the University of Arizona College of Pharmacy told MSNBC.

"It would be difficult for a generic manufacturer to reproduce the same release characteristics as the brand-name product," he stated.

"Such differences clearly could have an impact on patients," he said, "and my view is that sustained-release products are among the relatively short list of products that should not be switched."

Experts say the time release characteristics would be even more difficult to replicate in a generic version of Vancocin, where the concern is not just about how much of the drug is released into the blood stream but rather in one specific section of the GI tract.

The leaking of information in the Vancocin case is reminiscent of a major scandal that erupted during the first Bush Administration in 1989, when FDA officials were charged with taking bribes from generic makers and sharing insider information.

On August 28, 1989, Time magazine reported that an investigation by the Justice Department had uncovered evidence that "some makers of generic pharmaceuticals falsified laboratory test results and paid off FDA chemists to gain quick Government approval for their products."

In that case, Charles Chang the head of the FDA's generic division and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment for certain generic makers in July 1989, according to the Time report.

In the end, the generic scandal during the first Bush Administration landed Mr Chang in federal prison and caused 42 others and 10 companies to be convicted on charges of fraud and corruption and the FDA Commissioner Frank Young resigned in November 1989.

The crooks in the current Bush Administration's FDA deserve the same fate.

Evelyn Pringle

evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative reporter focused on exposing corruption in government and corporate America)

Authors Bio: Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

~~~

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 8th, 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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