Maggie Mahar writes on healthcare, economics and public policy. Her work has appeared in The New York Times, Barrons, Institutional Investor and may other publications. A regular contributor for THCB, her most recent book is "Money-Driven Medicine: The Real Reason Healthcare Costs So Much." She was recently named a fellow at The Century Foundation.
Only in America do physicians
who evaluate new drugs need bodyguards.
You may have read about the
brouhaha surrounding Provenge, a vaccine designed to extend the lives
of men suffering from late-stage prostate cancer. In March, a Food and
Drug Administration (FDA) advisory panel voted 13 to 4 to recommend
approval. The next day, shares of Dendreon, the drug’s sponsor, doubled.
But shareholders did not celebrate
for long. Two of the dissenting votes were cast by the panel’s two
prostate cancer specialists: Sloan-Kettering’s Howard Scher and the
University of Michigan’s Maha Hussain. And they did not just vote
“no”—following the hearing, both wrote to the FDA arguing that
Dendreon offered no solid evidence that Provenge works.
The FDA listened. And in May
it told the company it wouldn’t approve the drug until it had more
data. That is when the two oncologists began receiving threatening e-mails,
phone calls, and letters. Many were anonymous.
No doubt much of the hate mail
came from investors who had watched Dendreon’s shares climb from $5
in early January to $25.25 in late March—before plunging to $3 and
change. One Alabama shareholder expressed his feelings on his MySpace
page, where he asks “Hey, Hey, FDA, How Many Dads Did You Kill Today?”
while images of Hussain and Scher flash across a backdrop of crooked
crosses. Mozart’s “Requiem” plays in the background.
The response illustrates how,
in a money-driven health care system, those who view health care as
a profit center strive to dictate social policy. From their point of
view, the FDA should approve any product that Wall Street finds attractive—and
then let the market decide whether or not the drug is both safe and
effective. What they ignore is that, unlike other consumers, sick patients
are not in a good position to comparison-shop. They must rely on the
doctors and scientists who serve on FDA panels to sort through the hundreds
of offerings that drug makers hope to bring to market. For even if a
drug makes it to Phase III trials, this is no assurance that it is safe—or
that it will work. Indeed, a recent study shows that fully 40 percent
of new drugs fail in that final stage of testing.
So far, the FDA has not bowed
to investor pressure regarding Provenge, but the e-mails and phone calls
were too menacing to be ignored. When Hussain and Scher attended the
conference of the American Society of Clinical Oncology last month,
both asked for extra security guards. At that point, Hussain began wondering
whether she should continue as an FDA adviser.
Patients also protested the
FDA’s decision. Many had pinned their hopes on Provenge because it
is one of a group of new cancer drugs under development that uses the
patient’s own cells to create a vaccine designed to mobilize the patient’s
immune system to attack the cancer. The notion that the body might “heal
itself” is enormously seductive. For more than a century, oncologists
have dreamed of such a solution. But thus far, as Dr. Steven A. Rosenberg
of the National Cancer Institute confirmed in an e-mail to me last week,
“there are no therapeutic vaccines that have been shown to be effective.”
This is not what patients want
to hear. But while many were crushed by the FDA’s decision, patient
advocates such as PSA Rising disown the hate mail. "Folks, this is not grassroots
cancer patient activity, it’s . . . naked grassroots investor activity,”
wrote Jaqueline Strax, the editor of PSA Rising, in her newsletter for
prostate cancer survivors. “Ironically, some investors have whined
that prostate cancer patients are not helping THEM on behalf of Dendreon.” Roman">
Meanwhile, shareholders charged
that Sloane-Kettering’s Scher nixed the drug because he is the lead
investigator for a rival product. To drive this point home, earlier
this month Provenge activists raised $24,000 on the Dendreon message
board at Investor Village to buy a half-page ad in the Washington
“Prostate Cancer Victims Face Needless Suffering and Premature Death.”
Could this be true? Knowing
how much misinformation swirls around any new cancer drug, I decided
to take a close look at the transcript of the FDA hearing and find out
more about the scientific evidence behind Provenge.
This is when my skepticism
turned to shock. First, I learned that Dendreon has done two clinical
trials attempting to show that Provenge slows the progress of the cancer.
And that both failed. That’s right—the studies offered absolutely
no proof that the drug put a brake on the disease.
“It’s not clear why the
FDA panel was even voting on the drug—Provenge had already been check-mated,”
says Paul Goldberg, who broke the story by printing Scher’s letter
to the FDA in The Cancer Letter, a weekly newsletter about the
politics of cancer. . . .
In the meantime, “the stock
has become the momentum trading vehicle of 2007,” TheStreet.com’s
Adam Feuerstein wrote earlier this month. “A stock that will be pumped
and dumped based on the flimsiest of rumors and lowest-common denominator
Inevitably, the Wall Street
hype spills over into the mainstream media, where dying patients, willing
to grab at any thread of hope, read about a drug and begin to believe
that, if they could just get access to the “newest new thing,” it
might save their lives. (In fact, even the company claims only that
the average patient might win an extra 4½ months.) Those who
“pump” the stock do patients a cruel disservice.
Ultimately, Scher and Hussain
were not the only ones who would be intimidated by the Wall Street community.
I’ve written the full story of Provenge, discussing how it passed
the FDA panel, and whether individual patients should have the right
to gamble their lives on an unproven drug at http://www.tcf.org
Read the extended version of the story at http://www.tcf.org/Publications/HealthCare/healthbeat.pdf. Please return here to comment