This is Chapter 9 of a 15 chapter series. The entire series is listed here
Dr. Scher’s letter makes clear that his concern about Dendreon was not, strictly speaking, that it didn’t
work, but that it would render irrelevant his work on Novacea’s competing treatment, Asentar. A new
phase 3 trial to test the effectiveness of Asentar (referred to in the letter by its medical name, DN-101)
had been “designed, initiated and continues to accrue,” Dr. Scher wrote. “I am the International
Investigator on this trial.”
Nowhere in his letter (and nowhere in the conflict-of-interest waiver form that he submitted in order to get
a seat on the FDA advisory panel that voted on Dendreon’s treatment) did Dr. Scher mention that he was
not just the lead investigator in the Asentar trials, but also a board member and executive of Milken’s
ProQuest Investments, which was, along with affiliate Domain Associates, the biggest investor in
Novacea, the company that was developing Asentar.
Also left unmentioned was the fact that Dr. Scher was the chairman of the “Therapeutic Consortium” of
Milken’s Prostate Cancer Foundation. The “Therapeutic Consortium” helps Milken’s “philanthropic” outfit
decide which treatments and hospitals deserve its support. It is clear that the Prostate Cancer
Foundation’s donations to hospitals such as Dr. Scher’s Memorial Sloan are linked to the hospitals’
support of specific treatments being developed by specific Milken-affiliated companies.
For example, in one typical press release, the Prostate Cancer Foundation stated that the “Therapeutic
Clinical Investigation Consortium [the Milken Prostate Cancer Foundation outfit of which Dr. Scher is the
chairman] played an important role by accelerating testing of this new agent [Abiraterone, the agent
developed by Milken crony Lindsay Rosenwald’s Cougar Biotechnology] in Phase II clinical trials…Right
now, at MD Anderson and Memorial Sloan-Kettering, both NCI funded cancer centers, the Phase III trials
of Abiraterone [Cougar’s treatment] are going on. PCF contributions to Sloan-Kettering reached $18
million to date, possibly more…”
In other words, Milken raised money from unsuspecting donors, including the ordinary folks who slipped
cash into the buckets that the Prostate Cancer Foundation places outside of supermarkets and shopping
malls. Then Milken, with the support of Dr. Scher, directed that money to Dr. Scher’s hospital, with the
understanding that Scher and his hospital would attach their prominent names to drugs developed by
companies in which either Milken or Milken’s friends were investors.
Keep in mind that the prostate cancer drugs developed by Milken-affiliated companies were in the earliest
stages of development – there was not yet much evidence that they could help patients. But, as we will
see, there was lots of potential for them to make money for Milken and his friends.
Meanwhile, when Dendreon produced “substantial evidence” that its treatment could begin extending
lives right away, the Prostate Cancer Foundation and affiliated doctors diverted attention from the
treatment, and (in the case of Dr. Scher) worked vigorously to ensure that the treatment would not reach
This is not exactly “philanthropy” in its purest form.
Remember, on March 29, 2007, when Dr. Scher sat on the FDA’s advisory panel, he was one of the 17
doctors who voted unanimously that Dendreon’s treatment was safe. And two weeks later Dr. Scher
wrote a letter to the FDA in which he argued that the treatment should not be approved.
As mentioned, this letter was strange in that it was unprecedented for an FDA-contracted doctor to lobby
the FDA after an advisory panel had already voted. It was strange in that the presumably confidential
letter was quickly published by The Cancer Letter, an outfit with a reputation for being an organ of short
selling hedge funds. And the letter was strange in that it was disingenuous, to the say the least.
For one, Dr. Scher seemed to have changed his mind with regards to the safety of Dendreon’s treatment.
In his letter to the FDA, he noted that the advisory panel had discussed the fact that Dendreon’s trials
showed that 4.9% of patients treated with Provenge had experienced “cerebrovascular events” compared
to 1.7% of patients who were given a placebo.
The panel’s 17 doctors, Scher included, had voted unanimously that this was an acceptable risk for
patients with a deadly disease – especially since, in other regards, Provenge appeared to be perfectly
safe. But now Scher was insisting in a letter to the FDA that these rare “cerebrovascular events” (few of
which were fatal) were worrisome enough to deprive end-stage prostate cancer patients of a treatment
that might extend their lives.
But Dr. Scher’s “cerebrovascular events” argument was not new. It was precisely the same canard that
had been delivered to the press by those dubious Wall Street players — the singing Sendek, and doctorimpersonating Aschoff, the troubled UBS, and the whispering hedge fund managers.
As to the effectiveness of Provenge, Dr. Scher averred in his letter that Dendreon had not met its “primary
end-points” and the data was “not considered definitive.” He insisted that the treatment be delayed until
Dendreon could provide “proof” that Provenge extended lives.
This was absurd. As Dr. Scher must have known, rarely in history has data on an experimental treatment
shown definitive “proof” that the treatment works in every case. Instead, the legally established criteria for
FDA approval (especially of treatments for life-threatening diseases) is that the data show “substantial
evidence” that the treatment improves the health of patients. Neither medicine nor science progresses by
Even if trials do not meet their “primary end-points,” the FDA usually approves treatments for deadly
diseases if the odds are good that the treatments increase survival. The odds might not be 100 percent,
but if they are 98 percent, or even 51% percent, the treatment should be delivered to patients who will
otherwise die. This criteria – “substantial evidence” of increased patient survival – is referred to as “the
Gold Standard” by FDA officials and doctors everywhere.
In any case, “it may be time we focus less on statistical significance, and more on patient benefit.” So said
Dr. Scher himself, in an interview with a medical journal, just a few weeks before he wrote a letter to the
FDA harping on Dendreon’s statistical significance. Most likely, Dr. Scher was thinking about his trials of
Asentar (the drug under development by Novacea, which was controlled by Milken’s ProQuest
Investments and an affiliate) and Abiraterone (the drug developed by Milken crony Lindsay Rosenwald’s
Cougar Biotechnology). These trials had not yielded particularly good results.
In fact, as we will see, Asentar was not just unhelpful to patients. During trials of the treatment, patients
dropped dead. They dropped dead earlier than expected. And, as Novacea later acknowledged, the
cause was clear: Asentar actually killed a significant number of people who were hoped to benefit from it.
Provenge increased “cerebrovascular events” in a small number of patients, but patients on Asentar died
in such large numbers that Novacea had to discontinue its trials of the drug.
The question is: Did Milken’s Prostate Cancer Foundation, Dr. Scher, and the Wall Street hedge funds
really believe that Asentar and Cougar’s Abiraterone were superior to Provenge when they began their
attack on Dendreon? Or were their attacks motivated by their financial interests?
It was not necessary for Asentar to receive FDA approval in order for Milken’s ProQuest to make heaps of
money from its investment in Novacea. As we will see, the Milken clan had hatched a plan to cash in on
their Novacea stock, regardless of what the FDA had to say about the company’s prostate cancer
treatment, and regardless of whether that treatment would eventually kill an unacceptable number of
Same goes for Cougar Biotechnology’s investors, who included not just controlling shareholder Lindsay
Rosenwald (son-in-law of “king of stock fraud,” executive of Mafia-affiliated D.H. Blair, a firm indicted on
173 counts of securities fraud and famous for pumping phony biotech companies), but also two of the
seven Milken network hedge funds that were betting big against Dendreon. Cougar’s treatment,
supported by Milken’s philanthropy and by the four Prostate Cancer Foundation doctors who sat on
Cougar’s advisory board, was virtually untested, but as we will see, this did not prevent the company’s
investors from cashing in.
When Dendreon came under attack, similar plans to cash in had been hatched by investors in a company
called Cell Genesys, whose experimental (and, we will see, ineffective) treatment was promoted in a most
peculiar fashion (which I will describe in due course) by Milken’s Prostate Cancer Foundation.
Investors in those companies did not need FDA approval to make money, but as we will see, their moneymaking plans would have been foiled if Dendreon had received approval. In reading the transcript of the
FDA advisory panel meeting that voted on Provenge in March 2007, one has to wonder if Dr. Scher—who
led trials for not only Novacea and Cougar, but also Cell Genesys–knew of these money-making plans,
and if this knowledge informed the lobbying he undertook at the panel meeting, and in the days following
Among Dr. Scher’s more revealing statements at the advisory panel meeting was this: “So if I start
thinking, am I denying a potentially useful agent [Dendreon’s Provenge] to men who clearly need it, the
answer is unfortunately I don’t know. So I say, well, what if we think that this really should be available,
start thinking about the number of agents that are currently under development.”
This is the same message that was whispered in the ears of reporters, who eagerly transcribed it into
their stories. If the FDA approved Provenge, they said, it would become the standard of care. This would
be unfortunate because other treatments “under development” might be better. One problem with this
argument is that it would stop the FDA from approving any new drug, ever, And in this particular case,
another problem with this argument was that there were very few other treatments “under development.”
And when Dr. Scher referred to treatments “under development,” there was little else he could have been
referring to other than the above-mentioned Asentar (Novacea), Abiraterone (Cougar Biotechnology), and
GVAX (Cell Genesys).
As mentioned, Dr. Scher was connected to all three of those companies. Novacea’s Asentar, we know,
was killing people. At the time of Dr. Scher’s attack on Dendreon, Cougar’s Abiraterone had been tested
on a total of 38 patients. The data showed that some of those 38 patients saw their blood tests improve,
and Cougar Biotechnology trumpeted this information in multiple press releases, but there was zero
evidence that Abiraterone increased patient survival. GVAX had been tested on 80 patients, and some of
them lived longer, but the data did not yet show “substantial evidence” that GVAX was the reason.
All of these treatments had undergone only Phase 2 trials, whereas Dendreon had completed Phase 3
trials on 170 patients. The data from the Dendreon trials had reached statistical significance, and showed
that Provenge reduced mortality. In other words, none of the competing treatments (all financed by Milken
or Milken’s friends and promoted by Milken’s “philanthropic” foundation) had come anywhere close to
achieving results like Dendreon’s.
But Dr. Scher was insistent – ”a number of alternatives” [those “alternatives” being drugs under
development by Milken and his cronies with the assistance of Dr. Scher and Milken’s ‘philanthropy’, drugs
that would prove, in time, to be inferior] were “currently under development.” And so patients must not
have access to Dendreon’s drug – a drug that was capable of saving lives right away.
To understand the lengths to which some people went to derail Dendreon, it is necessary to recall the
Dendreon conference call, when the singing-Sendek kept asking whether the FDA might have to “change
the question.” Others on Wall Street were whispering about “the question,” the press transcribed into their
stories these same whisperings about “the question,” and Dr. Scher made “the question” a key feature of
his letter to the FDA. All of them suggested that the FDA advisory panel vote was invalid because the 13
panelists who had voted that Provenge worked had, in fact, voted on the “wrong question.”
The transcript of the Dendreon advisory panel meeting clarifies what was meant by all of this questioning
of the “question”. As noted, advisory panels are always asked to vote on two questions: Is the treatment
safe? And, is there “substantial evidence” that the treatment is effective?
This is not just custom. It is the law of the land. The 1962 Kefauver Harris Drug Amendments, ratified by
the U.S. Congress, stipulated that manufacturers of drug products must establish a drug’s effectiveness
by “substantial evidence.”
On the first question, “Is the treatment safe?” the advisory panel had voted “yes”, 17-0. Those 17 included
Dr. Scher (though, as has been explained, within weeks he was lobbying the FDA by raising doubts as to
the safety of Provenge).
The second question to be addressed was, therefore, “Is there substantial evidence that the treatment is
effective?” Dendreon had clearly met this standard – the “Gold Standard” of providing “substantial
evidence” of increased survival.
But remarkably, somebody at the FDA advisory panel meeting rewrote the “question.” The chairman of
the panel read the question out loud: “Does the submitted data establish the efficacy of [Provenge] in the
Immediately, there was confusion. This was not the usual question. Did “establish the efficacy” mean that
the panelists had to vote on whether the data had proved, with 100% conclusiveness, that Provenge
extended lives? No experimental drug had ever faced such a standard.
Dr. Scher interjected to say that Dendreon’s trials had failed to meet their “two primary end-points.” To
this, the FDA’s representative on the panel, Cecilia Witten, remarked that the FDA was aware that the
trials failed to meet its two primary endpoints, but that was not the issue. The issue was whether the
evidence suggested that Dendreon’s treatment saved lives.
“You know,” Witten said. “We’re given the application based on survival.”
The chairman of the panel resumed with the same question. “Again I’ll read it,” he said. “Does the
submitted data establish the efficacy…?”
Thus began the voting. Dr. Scher quickly voted, “No.” So did another physician, Dr. Maha Hussain, and
two other doctors. But confusion reigned.
One panelist, a certain Dr. Alexander, said, “So that’s – so my vote is, I don’t know what you would call
A Dr. Chamberlain said, “Well, so I guess at this point I’m not sure how to answer this question. It’s not a
yes or no question in my opinion the way it’s phrased. With the safety data and with what we’ve seen, I
see no reason not to make this drug available, but I don’t think it’s 100 percent proven that it’s
A Dr. Chappell said, “There’s a degree of belief, and ‘establish’ implies much more certainty…you need
please, to specify, at least to me, what you mean.”
A Dr. Alexander piped in, “Like is it a reasonable doubt, a shadow of a doubt?”
At this, there was a lot of mumbling and some laughter. Finally, the FDA’s representative clarified. “Yes,”
she said, “the regulatory definition is ‘provide substantial evidence.’ So that’s our standard. Is there
substantial evidence that it works…”
The chairman of the committee responded, “So just to clarify what you’re asking, is there substantial
evidence that the product is efficacious?”
“Yes,” said the FDA’s representative.
That resolved any doubts, and 13 of the 17 doctors on the panel confidently voted “Yes.” That is to say,
when the doctors voted on the correct question – the question that was stipulated by law, as opposed to
the question that had been tampered with — the overwhelming consensus was that Dendreon’s treatment
should be approved.