A Cure for Your Cancer Would
Only Interfere with their Plans for Population Control
When Drug Companies Are Hazardous To Your Health:
Lifesaving Cancer Drug Bexxar Discontinued By GlaxoSmithKline (NYSE:GSK),
Experimental Drugs Withheld
By Jamie Reno
on January 31 2014 11:02 AM
The headquarters of GlaxoSmithKline,
manufacturer of the cancer-treating drug Bexxar, which is being discontinued
due to disappointing profits. Reuters/Toby Melville.
These are the final days for
Bexxar, a lifesaving cancer treatment that drug giant GlaxoSmithKline (NYSE:GSK) announced last summer would be
discontinued on Feb. 20 because it wasn’t earning the company enough money.
That harsh reality has begun to sink in for those who adamantly oppose GSK’s
decision to scrap this effective, safe, FDA-approved
therapy for lymphoma, the nation’s seventh most common cancer for men and
women.
“As a corporate CEO, I understand
that GSK might kill a drug that loses money, but what I don’t understand is why
they seemed to not be willing to make the modest investments required to make
this lifesaving treatment a success,” said Michael Werner, who runs several
companies, is a lymphoma survivor, and sits on the board of directors for the
Lymphoma Research Foundation, the nation’s largest nonprofit dedicated to
funding lymphoma research.
Werner said GSK, the
fourth-largest pharmaceutical company in the world with revenues in the third
quarter of 2013 of $10.1 billion, had all the tools to make Bexxar successful.
“It seems like maybe they lacked
the will,” he said. “What a shame that thousands of patients will now be denied
a treatment that might have saved their lives. It shouldn’t and doesn’t have to
be this way.”
The discontinuation of Bexxar is
an extreme example of a lifesaving drug being eliminated due to its relatively
low profitability. In most cases, when a pharmaceutical company concludes that
a niche drug is not making enough money, the product is sold to another,
smaller company which continues to make it available. But continued
availability is left to the discretion of the company (or companies) that owns
the rights to the drug, which is how pharmaceutical companies can withhold
potentially lifesaving experimental drugs that have not yet been approved by
the FDA -- often, due to concerns that a potential problem resulting from such
use could jeopardize the drug's ultimate approval.
Bexxar, a radio-immunotherapy
(generally known as an RIT), approved in 2003 in the U.S. for people with non-Hodgkin’s
lymphoma, homes in on tumor cells with a radioactive isotope, iodine-131,
killing the cancer but generally sparing normal tissue. Numerous studies show
that Bexxar gives non-Hodgkin’s lymphoma patients longer remissions than any
other treatment, including the standard of care: chemotherapy plus the
monoclonal antibody drug Rituxan, and with fewer harsh side effects.
But the therapy, which was touted
by NBC’s Dateline back in October 1998 as a new wonder drug, never really
caught on with oncologists and hematologists, who typically prefer to prescribe
traditional chemo plus Rituxan, which can be given in a doctor’s office.
Because of its radiation component, Bexxar must be administered by a doctor who
is licensed in nuclear medicine or radiation oncology.
While Bexxar saved this writer’s
life in a clinical trial in 1999 with virtually no side effects and has saved
many other lives, sales of the drug did not meet GSK’s expectation. Catalina
Loveman, GSK’s director of U.S.
external communications, oncology, told IBTimes that total sales of Bexxar in
2012 in the U.S. and Canada were
approximately $1 million; for comparison, the blockbuster drug Viagra earned
Pfizer a reported $2.05 billion in sales in 2012.
In a statement last August, GSK
said its decision to stop manufacturing Bexxar involved a “thoughtful and
careful evaluation of patient needs and the clinical use of the therapy. The
use of Bexxar has been extremely limited and is projected to continue to
decline.”
Loveman said GSK “invested
substantially in Bexxar throughout its lifecycle,” and said that the company’s
“commitment to patients with cancer and the oncology community will continue
through our efforts to develop and deliver other cancer therapies aimed at
strengthening standards of care and addressing unmet needs.”
GSK would not divulge how much
money was spent to market Bexxar, or why the drug was never advertised in print
or on television, or what, if any, efforts were made to sell the drug to
another company rather than just dump it. But a number of patient advocates,
patients and oncologists interviewed for this story questioned GSK’s commitment
to the therapy, and asked if this or any drug company should be legally allowed
to simply stop manufacturing a cancer drug that works so well.
“No other treatment has shown to
produce the results that Bexxar has shown,” said Betsy de Parry, a patient
advocate, 12-year lymphoma survivor and author of "Adventures in Cancer Land." “Given the recurring nature of lymphoma,
which requires successive treatments, and Bexxar’s results, it is tragic to
lose this option. I know people who took Bexxar in clinical trials as long as
19 years ago who remain disease-free. Don’t others deserve that same chance?
These are real human beings we’re talking about, not statistics, not profit
margins.”
Tom Stark, also a patient advocate
who was treated with Bexxar two years ago, said that if GSK advertised the
drug, perhaps more people would know about it and would have asked their
doctor.
“I only knew about Bexxar because
I spent around 100 hours researching lymphoma on the Internet,” Stark said.
“Not everyone has the time or the ability to do that. Bottom line: Bexxar saves
lives, and losing it means that more people will die needlessly.”
Good For Business, Not Good for
Patients
This isn’t the only time in recent
memory that a drug company appears to have made a decision that has more to do
with what is good for business than with what is good for patients. Last year,
pharmaceutical companies Merck and Bristol-Myers Squibb (BMS) both declined to
give their lifesaving treatment to a 41-year-old husband and father of three
young children who was dying from stage 4 melanoma.
Nick Auden bravely campaigned for
access to a clinical trial of anti-PD-1, a treatment currently being tested
separately by Merck and BMS, but could not convince either company to give him
the drug. His family initiated an Internet campaign to urge the drug companies
to allow Auden special consideration. A
petition on Change.org generated more than a half million signatures.
Stage 4 melanoma has long been
considered incurable, but this new anti-PD-1 drug, which helps the immune
system attack the cancer, is showing remarkable, unprecedented results in these
trials for patients like Auden. Studies of Merck’s version of the drug found
that 52 percent of participants who took the higher dose of the drug in a
clinical trial saw their tumors shrink. Auden’s doctors told him they believed
it was his only chance to survive, and several other prominent oncologists that
the family contacted agreed.
But the drug companies were
unmoved, and Auden died on Nov. 22. Bristol-Myers Squibb cited safety concerns
for not giving Auden the drug, while Merck said it didn’t have enough of the
drug to give it to him. Auden’s widow, Amy Auden, doesn’t believe either
company is telling the truth.
“These were late phase-three
clinical trials. These drug companies both knew full well this drug was safe,”
Amy Auden told IBTimes. “This was all about the companies not wanting to do
anything to jeopardize the [FDA’s] approval of their product. It could have
cost them millions of dollars if something bad had happened in Nick’s case and
it somehow delayed that approval. They put profit above people.”
As for the decision to dump
Bexxar, a spokesperson for GSK noted that there are other treatment options
available for patients with relapsed non-Hodgkin’s lymphoma. And that is true:
There is still chemotherapy and Rituxan. And there is Zevalin, a drug that,
like Bexxar, is an RIT, and has been shown in studies to be very effective.
Some patients respond better to one treatment than the others. As Stark said of
Zevalin, “The radiation is different, it does not travel as far, and while it
is good, it is in my opinion not as good as Bexxar.” Others disagree with that
assessment, but no one disputes that both drugs are safe and very effective
cancer fighters, and almost everyone interviewed for this story -- other than
GSK -- said patients should have access to both.
Like Bexxar, Zevalin has also
struggled in the marketplace. In the third quarter 2013, Zevalin’s profits were
$8 million. But unlike GSK, Spectrum Pharmaceuticals, makers of Zevalin, is
committed to keeping this drug on the market.
“What is happening with Bexxar is
virtually unprecedented,” said Spectrum’s chief operating officer, Ken Keller,
who came to Spectrum a year and a half ago from California-based Amgen, the world's
largest independent biotech company. “I do not know of a single example of a
drug company that has walked away from a drug that is this effective.
Typically, when a company gives up on a treatment that works this well, they
will a find a smaller company to sell it.”
Keller acknowledged that neither
Bexxar nor Zevalin has been able to break through and become the blockbuster
drugs that he says they both should be.
“I’ll be honest: We don’t gain a
lot of value from Zevalin,” he said. “We have the data that shows how well it
works, but it has still not caught on with many doctors. However, Spectrum will
continue to manufacture Zevalin because our CEO [Raj Shrotriya] is on a mission
to make RIT the standard of care for lymphoma in the U.S.. If this were only about
finances, it could lead to different decision. But this treatment saves lives,
and we believe we have an obligation to cancer patients. They deserve to have
access to it.”
Dr. Lawrence Piro, a Los Angeles oncologist
and president and CEO of The Angles Clinic and Research Institute, uses Bexxar
as well as Zevalin in his clinic. He said he strongly believes both drugs
should remain available to patients, and said the blame for the demise of
Bexxar must be shared by GSK and American oncologists.
“While we can talk about how sad
it is for patients that a drug company makes a decision like this, we also have
to look to the oncology community and ask why it never adopted or supported
this therapy,” Piro said. “Some doctors resisted it because it was easier to
give chemo and/or Rituxan, and some had fears that there would be as-yet
undetermined long-term consequences to this treatment. And for many doctors,
Bexxar was problematic because in most cases the oncologist does not administer
the therapy; you need a nuclear medicine doctor to administer it. All of this
resulted in a disconnect and made doctors feel like it was too complicated and
out of their comfort zone.”
But, Piro emphasized, “The truth
is Bexxar is a highly effective cancer therapy, and none of these factors are
compelling enough for doctors to not tell patients about it as an option. I
believe that it is important for patients to hear about all of their options,
and I am very sorry to see it go. However, I am happy that there is another RIT
available for patients who might want to use it.”
Critics of GSK’s decision to
discontinue Bexxar, as well as critics of Merck and BMS’s decision to not allow
Auden to be treated with their respective drugs, believe that new laws should
be passed to compel drug companies to consider sick and dying patients and not
just the bottom line.
“I don’t believe a drug company
should ever be allowed to just get rid of a cancer treatment that works so
well,” Stark said.
Added Amy Auden, whose campaign
for her husband attracted support from cancer experts, politicians, celebrities
and even the FDA: “I am hoping we will see legislation someday soon that forces
drug companies to provide compassionate access to potentially lifesaving
medicines in late-phase trials.”
GlaxoSmithKline plc
Tadataka Yamada
was the chairman of research & development for GlaxoSmithKline plc, and the president, global health program for
the Bill & Melinda Gates Foundation.
Note: Ann
M. Fudge is the U.S.
program advisory panel chair for the Bill
& Melinda Gates Foundation, a trustee at the Brookings Institution (think tank), and was a trustee at Morehouse College.
Robert
Wilson was a trustee at Morehouse College,
and is a director at GlaxoSmithKline plc.
Stephanie A.
Burns is a director at GlaxoSmithKline
plc, and was a trustee at the Conference
Board.
G.J.
Wijers is a director at GlaxoSmithKline
plc, and a trustee at the Conference
Board.
Klaus Kleinfeld is a trustee at the Conference Board, a trustee at the Brookings
Institution (think tank), and a 2008 Bilderberg conference
participant (think tank).
Mark B. McClellan
was a senior fellow at the Brookings Institution (think tank), and a commissioner
for the U.S. Food and Drug
Administration (FDA).
Michael A.
Friedman was the acting commissioner for the U.S. Food and Drug Administration (FDA), the chief medical officer Pharmaceutical Research and Manufacturers
of America, and the associate director for the National Cancer Institute.
GlaxoSmithKline
plc is a member firm of the Pharmaceutical
Research and Manufacturers of America.
Margaret A.
Hamburg is the commissioner for the U.S.
Food and Drug Administration (FDA), the VP for the Nuclear Threat Initiative (think tank), and her father is David A. Hamburg.
Carnegie
Endowment for International Peace (think
tank) was a funder for the Nuclear
Threat Initiative (think tank).
Jessica Tuchman Mathews is a director
at the Nuclear Threat Initiative (think
tank), the president of the Carnegie Endowment for International Peace
(think tank), a director at the American Friends of Bilderberg
(think tank), was an honorary trustee at the Brookings Institution (think
tank), and a 2008 Bilderberg conference participant (think tank).
Ed Griffin’s interview with
Norman Dodd in 1982
(The investigation into the
Carnegie Endowment for International Peace uncovered the plans for population
control by involving the United
States in war)
Foundation
to Promote Open Society was a funder for the Brookings Institution
(think tank), and the Carnegie Endowment for International Peace (think
tank).
George Soros
was the chairman for the Foundation to Promote Open Society.
Andrew Carnegie
was the founder of the Carnegie Endowment for International Peace (think
tank), the founder of Carnegie Hall,
and the founder of the Carnegie
Corporation of New York.
Deryck C. Maughan
was a trustee at Carnegie Hall, the chairman
& CEO for GlaxoSmithKline plc,
and is a director at GlaxoSmithKline plc.
David A. Hamburg
is the president emeritus for the Carnegie
Corporation of New York, the FDA
commissioner Margaret A. Hamburg’s
father, and an adviser for the Nuclear
Threat Initiative (think tank).
Newton
N. Minow is an honorary trustee at the
Carnegie Corporation of New York, a member of the Commercial Club of Chicago, and a senior counsel at Sidley Austin LLP.
R.
Eden Martin is the president of the Commercial
Club of Chicago, and counsel at Sidley
Austin LLP.
Michelle
Obama was a lawyer at Sidley Austin
LLP.
Barack
Obama was an intern at Sidley Austin
LLP.
Obamacare
is Barack Obama’s signature policy
initiative.
CGI Group Inc.
was the Obamacare contractor that
developed Healthcare.gov web site.
Barbara G. Fast
was a VP for the CGI Group Inc., and
a VP at the Boeing Company.
W. James
McNerney Jr. is the chairman & president & CEO for the Boeing Company,
and a member of the Commercial Club of
Chicago.
Thomas R.
Pickering was the SVP for the Boeing
Company, a trustee for the Carnegie
Corporation of New York, the chairman of review board that investigated the
2012 attack on U.S. consulate in Benghazi, Libya
in 2013, and is a distinguished
fellow at the Brookings Institution
(think tank).
Carnegie
Corporation of New York was a funder for the Brookings Institution (think tank).
Bill
& Melinda Gates Foundation was a funder for the Brookings Institution (think tank).
Ann
M. Fudge is the U.S.
program advisory panel chair for the Bill
& Melinda Gates Foundation, and a trustee at the Brookings Institution (think tank).
Tadataka Yamada
was the president, global health program for the Bill & Melinda Gates Foundation, and the chairman of research
& development for GlaxoSmithKline
plc.
Jon M. Huntsman
Jr. was a distinguished fellow at the Brookings
Institution (think tank), is a trustee at the Carnegie Endowment for
International Peace (think tank), and the chairman for the Huntsman Cancer Foundation.
Jessica Tuchman Mathews was an honorary
trustee at the Brookings Institution (think tank), is the president of
the Carnegie Endowment for International Peace (think tank), a director
at the American Friends of Bilderberg (think tank), a director at the Nuclear Threat Initiative (think tank),
and a 2008 Bilderberg conference participant (think tank).
Ed Griffin’s interview with
Norman Dodd in 1982
(The investigation into the
Carnegie Endowment for International Peace uncovered the plans for population
control by involving the United
States in war)
Margaret A.
Hamburg is the commissioner for the U.S.
Food and Drug Administration (FDA), the VP for the Nuclear Threat Initiative (think tank), and her father is David A. Hamburg.
David A. Hamburg
is the FDA commissioner Margaret A. Hamburg’s father, an adviser
for the Nuclear Threat Initiative (think
tank), and the president emeritus for the Carnegie Corporation of New York.
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