Who in the government helped sabotage Dendreon? Despite the lobbying by the captured doctors, despite the Wall Street whispering, despite the singing Sendek and the media mimics — despite all of this, it still seemed likely that the FDA would heed the advice of its advisory panel.
Instead, the FDA told Dendreon that it would not yet approve its treatment — that the company had to get more data, which would take years, by which time the company could easily run out of money. The FDA handed Dendreon (and prostate cancer patients) what seemed like a death sentence. This was a strange occurrence. It must have followed some serious work by government officials in high places.
One official who might have advocated against Dendreon was then FDA Commissioner Andrew von Eschenbach, who was a close ally of Michael Milken. Dr. von Eschenbach was a founding director of Milken’s Prostate Cancer Foundation, and later he was at the forefront of an ultimately unsuccessful effort to convince George Bush to grant a presidential pardon forgiving Milken for his crimes. But it is clear that von Eschenbach was not the only official courted by Milken and his associates.
Long before I came along, an assortment of Dendreon shareholders, prostate cancer patients, honest folks on Wall Street (there are some), and concerned citizens spotted the connections among Milken, ProQuest and the captured doctors who led the lobbying effort against Dendreon. When the FDA failed to approve Provenge, these folks saw that an injustice had been done, and they hollered loudly. Soon after, a grass roots organization called Care-to-Live was founded to advocate on Dendreon’s behalf.
Care-to-Live (to whom I owe a debt of gratitude for uncovering some of the information that appears in this story) has not only chronicled Dendreon’s travails, but has also labored tirelessly to right the wrongs. It has organized street protests and letter-writing campaigns. It has lodged Freedom of Information Act requests and it has filed a lawsuit against the FDA. In the course of these efforts, it managed to get a hold of various documents and email communications between Dr. Scher (the physician with financial ties to Milken’s companies and “philanthropy”) and officials in the government bureaucracy.
What these documents and emails show is that Dr. Scher and his allies depended largely on support from a mid-level FDA employee and the National Cancer Institute, which oversees government funding of cancer initiatives, and has considerable, though unofficial, influence over FDA decisions. Over the years, Milken and his Prostate Cancer Foundation have made great efforts to ingratiate themselves with the NCI, which may be one reason why Dendreon was never able to receive government funding, despite the revolutionary potential of its treatment.
On March 31, 2007, Alison Martin, who was in charge of the prostate cancer division of the National Cancer Institute, emailed Dr. Scher, who was busy crafting the missive that would be published with mysterious immediacy by The Cancer Letter. “Glad to hear letter is being drafted,” Martin wrote. “If that [FDA] division’s vote suggests [that Dendreon’s treatment] be considered for approval, I was wondering if it then could go to ODAC, which is more clinically savvy, i.e. this is just a step in a process.”
The “division” whose possible approval of Dendreon’s treatment so discomfited Dr. Martin was the FDA’s Center for Biologic Evaluation & Research (CBER), which was assigned the task of evaluating Dendreon’s application. Martin was suggesting that if CBER was going to approve Provenge, perhaps the matter could be taken to ODAC – the FDA’s Oncologic Drugs Advisory Committee, which was led by an FDA official named Dr. Richard Pazdur.
Pazdur has a close relationship with a Washington lobbyist named Samuel D. Turner. Some years ago, Turner, who helps run an organization called the Cancer Leadership Council, led a campaign to have Pazdur appointed as the commissioner of the FDA. Michael Milken supported that campaign. And Milken’s advisors, such as Dr. Donald Coffey of the Prostate Cancer Foundation, have collaborated closely with Turner in another cancer lobbying group called C-Change, of which the Cancer Leadership Council is an affiliate.
As a result of this support, Milken and Pazdur have become very close friends.
Some years ago, a U.S. Congressional investigation determined that Pazdur, through his lobbyist friend Turner, had leaked inside information that the FDA was going to reject Erbitux, a cancer drug that was developed by ImClone. As you will recall, that inside information made its way to Martha Stewart, setting in motion the chain of events that landed her in jail. The ImClone inside information also was first published in The Cancer Letter, the same rag that published Dr. Scher’s “confidential” letter to the FDA. And, remember, the records of phone calls made to ImClone at that time raise the distinct possibility that funds managed by Milken cronies Carl Icahn, Steve Cohen, and Dirk Ziff also were privy to that information before it was made public.
As an aside, after ImClone’s stock crashed on the news, the company was seized by Milken crony Carl Icahn. And soon after Martha Stewart received the inside information, but before she was caught, hedge funds in the Milken network began short selling Martha Stewart’s company, Martha Stewart Living Omnivision. One hypothesis that explains the exquisite timing of those hedge funds is that the funds knew Martha was going to be arrested and therefore shorted her company on the assumption that news of her arrest would crash the stock. They may even have been the ones who turned her in. But that is a story for another time.
For now, it merely needs to be emphasized that Pazdur, the FDA official, has unusually close relationships with Milken and some of his cronies. He was a key player in the ImClone scandal, which displays remarkable similarities (such as insider information mysteriously appearing in The Cancer Letter and the involvement of hedge funds in the Milken network) to the Dendreon scandal. And Pazdur appears to have been the FDA official most responsible for derailing Dendreon’s prostate cancer treatment.
Pazdur was not supposed to be the one who decided whether Dendreon’s drug was approved. Instead, because the drug is a biologic, the decision rested with the FDA’s Center for Biologics Evaluation and Research (CBER). Nonetheless, Pazdur inserted himself into the decision process. It was at Pazdur’s behest that Dr. Scher and Dr. Hussain were, despite their ties to competing companies controlled by Milken’s funds and friends, appointed to the advisory panel that voted on Dendreon’s application.
As you will recall, Dr. Scher and Dr. Hussain were among the four panelists who quickly voted “No” to the incorrectly phrased question about Dendreon’s effectiveness. When the phrasing was changed to the correct, legally mandated question ( Is there “substantial evidence” that the drug reduces mortality?) the remaining 13 experts on the panel voted “Yes.”
According to eyewitnesses, just as panelists began voting “Yes,” Pazdur began passing notes to Dr. Maha Hussain, who then attempted to instill further confusion, apparently hoping to have the remaining panelists continue to vote on the incorrect question. Pazdur, who had come to the meeting uninvited and unannounced, also spent a good deal of time conversing with Dr. Hussain, giving the impression that they were working together to devise arguments that might turn the panel against Dendreon.
Curious to know whether it was Pazdur who ultimately derailed Dendreon’s application, perhaps even delivering the captured doctors’ “confidential” letters to The Cancer Letter – and wondering whether this had anything to do with Pazdur’s relationship with Michael Milken — Care-to-Live, as part of its lawsuit against the FDA, subpoenaed Pazdur’s relevant emails and documents.
Pazdur responded under oath as follows: “I searched both my paper and computer files and was unable to locate any documents that were responsive to Plaintiff’s requests. I recall receiving…these letters…However, as these letters related to a specific regulatory application conducted by a different FDA Center (CBER), did not fall under my direct regulatory supervision…I shredded my hard copies of these letters and deleted any electronic copies. The documents were shredded and deleted within a month of receipt.”
This response was strange. For one, Pazdur seemed to be stating that he had no involvement in the Dendreon decision. If that were the case, what was he doing at the advisory panel meeting? Pazdur’s statement also contradicted an earlier statement from the FDA. In response to complaints that Pazdur had participated in a decision that was supposed to be left to the CBER division, the FDA said that he had done so “at CBER’s request.” Clearly, Pazdur had been involved in the decision, so it was disingenuous for him to state otherwise in his efforts to explain why he had (frantically?) shredded and deleted all the relevant documents.
Moreover, if Pazdur is telling the truth (and not, that is, simply obstructing justice), then Pazdur violated the spirit of various initiatives, including a bill passed in the U.S. House of Representatives and directives from the Archivist of the United States, aimed at ensuring that government employees maintain records of their official business. The reason that government officials are asked to keep good records is that they are sometimes involved in controversies – controversies such as the one that was swirling around Dendreon’s FDA application when Pazdur began shredding and deleting documents so promptly and thoroughly.
In any case, most of the documents that Care-to-Live requested had been transmitted electronically, meaning that a simple computer excavation could have retrieved them, even if they were deleted. Clearly, Dr. Pazdur had reason not to hand over those documents. Perhaps he was advised not to by his lawyer, who happens also to be the same lawyer who represents The Cancer Letter, the rag that published the “confidential” letters that Dr. Scher and Dr. Hussain wrote to Dr. Pazdur and FDA commissioners.
Fortunately, Alison Martin of the National Cancer Institute did not shred everything – she handed over at least some of her documents. And the email quoted above strongly suggests that her plan was to get Dendreon’s application out of the hands of the designated authority, CBER, and into the hands of Richard Pazdur. In response to that email, Dr. Scher wrote to Martin that he, too, would try to have Dendreon’s application “reviewed by ODAC” (which was controlled by Pazdur). In a follow-up email, Dr. Scher wrote: “Got a minute for quick question related to FDA processes?”
A minute later, Martin responded: “Consider this confidential, please…but I wanted you to know.” As to what confidential information she delivered to Scher, that is unclear from the documents received by Care-to-Live. Apparently, the telling documents were also promptly shredded.
But other documents and emails show that by early April, Martin was fully engaged in helping Scher draft his letter trashing Dendreon — the “confidential” letter to the FDA that would be quickly published by The Cancer Letter. Indeed, a copy of a half-edited draft of Dr. Scher’s letter was found on Martin’s computer. And in one email, Martin appears to complain about all the work she has done on this letter. “Maybe you should write a letter, too,” she jokes.
So an employee of the federal government was helping a conflicted doctor lobby the federal government. That is, Martin, the head of the prostate cancer unit at the National Cancer Institute, was helping a doctor – a doctor with financial ties to Michael Milken and to a competing, Milken-invested company — sabotage Dendreon’s treatment for prostate cancer.
As news of this started to reach Dendreon’s supporters, Martin left her job at the National Cancer Institute. Soon after, she was appointed president and chief executive officer of the Melanoma Research Alliance (where one can safely suppose her compensation exceeds her previous government salary).
The Melanoma Research Alliance was a brand new “philanthropic” outfit. It had just been set up by a “prominent philanthropist.”
The name of the “prominent philanthropist” is, of course, Michael Milken.
Milken founded the Melanoma Research Alliance and hired Alison Martin with an initial grant from Leon Black, the “prominent” billionaire and Milken crony who does business with an alleged Russian mobster named Felix Sater.
Sater, remember, is the fellow who allegedly was behind the threat to have Deep Capture reporter Patrick Byrne murdered if Patrick did not end his crusade against abusive short selling and the “deep capture” of the nation’s regulatory bodies.
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On May 11, three days after the FDA failed to approve Dendreon’s treatment, The Wall Street Journal published a report that purported to investigate the allegations that the government approval process had been compromised. This “investigation” entailed asking Dr. Scher whether he had any conflicts of interest.
“’I try to keep to the high ground,’” Dr. Scher told The Journal. Apparently content with his reply, and eager to assuage any suspicions that something nefarious had gone down, The Journal added that Dr. Scher “serves as an advisor to Innovive, a small biotech not involved in prostate cancer, and works with Bristol-Myers Squibb in an unpaid capacity on early stage drugs that may hold promise in prostate cancer. He and his wife hold small amounts of stock in Biogen, Idec and Pfizer.”
That was it. According to the Journal, Scher had no conflicts of interest.
The Journal did not mention that Dr. Scher was a board member and executive of Milken’s ProQuest Investments. It did not mention the fact that ProQuest was heavily invested in Novacea, a Dendreon competitor. It did not mention that Dr. Scher was leading the trials of Novacea’s prostate cancer drug, or that he was a paid director on the advisory board of another Dendreon competitor – Milken crony Lindsay Rosenwald’s Cougar Biotechnology. And it did not mention that Dr. Scher was leading clinical trials for yet another Dendreon competitor, Cell Genesys, which, like Cougar and Novacea, was supported by Milken’s Prostate Cancer Foundation, whose “Therapeutic Consortium,” was chaired by none other than Dr. Scher.
The Wall Street Journal did not mention any of this, despite the fact that concerned citizens had plastered the information all over the Internet.
Four days after the Journal article appeared– May 15, 2007 – the FDA issued new guidelines for evaluating immunotherapy agents, such as Dendreon’s treatment. Now it was official – Pazdur’s division would have some influence.
This seemed like the FDA was papering over a scandal. If Pazdur had violated the guidelines by influencing the Dendreon decision, now the FDA could say that, in fact, there were new guidelines, and Pazdur had followed them (never mind that the new guidelines were written one week after the FDA failed to approve Dendreon’s treatment, possibly because Pazdur had violated the old guidelines).
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Just a few weeks after the FDA said it would not yet approve Dendreon’s treatment, it was easier to understand why Dr. Scher, Milken and their allies were so eager to see Dendreon fail. On May 30, 2007, Novacea, the company whose largest investors were Milken’s ProQuest Investments and the affiliated Domain Associates, announced that it had signed a $500 million deal to jointly develop its prostate cancer treatment with pharmaceutical giant Schering Plough. Within 24 hours, Novacea’s stock price jumped 86 percent.
In subsequent days, the business media reported this “news” as if it were not just a business triumph, but also a major breakthrough in the world of medicine. “On Tuesday, Novacea was just another young biotech, with a modest market capitalization of $187 million,” enthused Forbes magazine. “That all changed on Wednesday when the drug maker announced it had signed a deal worth over $500 million with pharma juggernaut Schering-Plough.”
Forbes added that Novacea’s treatment “appears to significantly increase the chance of survival among androgen-independent prostate cancer patients…”
As this $500 million figure and news of Novacea’s medical miracle made its way around the other news organizations, and appeared everywhere on the Internet, Novacea’s stock continued to soar.
Nobody in the media paused to consider whether a “$500 million deal” constitutes a medical breakthrough (like, for example, reducing mortality by 20% in late-stage prostate cancer patients, as Dendreon had done). The assumption was, if there is big money and the stock is soaring, the company’s prostate cancer treatment must be good.
Furthermore, nobody in the media paused to consider that had Dendreon received approval for its competing treatment, this “$500 million deal” would almost certainly not have happened. Nor did anybody in the media report that the people (Milken and friends) who stymied Dendreon were the same people who stood to profit from this purported “$500 million” deal.
At any rate, the deal was not quite what it was made out to be. Novacea did not receive $500 million. It received $60 million up front. Meanwhile, Schering-Plough was given $12 million worth of Novacea stock at a bargain price. By cashing out of the stock after it soared in value, Schering-Plough could significantly reduce that upfront investment. The rest of the much-trumpeted $500 million was dependent on Novacea’s clinical trials showing that its cancer treatment actually improved the health of patients.
Sure enough, just a few months later, in November 2007, Novacea announced that the clinical trial of its treatment had been terminated “due to an unexplained imbalance of deaths…” In other words, Novacea’s drug was not improving the health of patients. It was killing patients. And as soon as this news was released, the much-heralded $500 million Schering-Plough deal was cancelled.
Either shortly before or soon after the trials were terminated due to an “imbalance of deaths,” Milken’s ProQuest Investments and Domain Associates sold their stock in Novacea. Given the enormous boost the stock price had received after the “$500 million” news, it appears that ProQuest and Domain (i.e. Michael Milken and friends) sold their stock at a significant profit.
So the questions remain: Did Dr. Scher (who worked for ProQuest and lead Novacea’s clinical trials) really believe that Novacea’s treatment was superior, as he claimed during his successful campaign to get the FDA to reject Dendreon’s drug? Did Michael Milken’s Prostate Cancer Foundation, which was an extension of ProQuest and snubbed its nose at Dendreon’s treatment, really believe that there were better treatments in the pipeline?
Did ProQuest and its affiliate Domain, which founded Novacea, ever care about producing a marketable drug? Or was Novacea a scam? A scam that was built on real science (though Dr. Scher was less than upfront about the results of his clinical trials, his efforts to develop Novacea’s treatment were no doubt sincere). A scam that was more sophisticated than those perpetrated by the bucket shops of yore, and whose every component may have been technically legal.
But nonetheless a scam – an old-fashioned pump and dump scam.
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This is part 11 of a 15-part series. The remaining installments will appear on Deep Capture over the next several weeks, after which point the story will be published in its entirety at DeepCapture.com. It is a story about the travails of just one small company, but it describes market machinations that have affected hundreds of other companies, and it contains a larger message for anyone concerned about the “deep capture” of our nation’s media and regulatory bodies.
Mark Mitchell is a reporter for DeepCapture.com. He previously worked as an editorial page writer for The Wall Street Journal in Europe, a business correspondent for Time magazine in Asia, and as an assistant managing editor responsible for the Columbia Journalism Review’s online critique of business journalism. He holds an MBA from the Kellogg Graduate School of Management at Northwestern University. Email: mitch0033@gmail.com
