Monday, November 14, 2016

A Hot Souvenir From Cuba for Some Americans - Cancer Vaccine

A Hot Souvenir From Cuba for Some Americans: Cancer Vaccine
By SALLY H. JACOBS NOV. 14, 2016

Zuby Malik is an unlikely candidate to violate international law. A
78-year-old mother of four with a crown of silver hair, she is a retired
obstetrician-gynecologist with a penchant for order.

But Dr. Malik is fighting for her life. After receiving a Stage 4
non-small-cell lung cancer diagnosis a year ago, she exhausted many of
the treatments available to her and grappled with torturous side effects
that left her itching and gasping for breath. During the summer, she
decided to go to Cuba and bring back a cancer vaccine that is not
approved in the United States. That she comes from a family steeped in
medical training made the decision all the more difficult.

"At first I was a little nervous," said Dr. Malik, sitting in her
Northern California living room flanked by an oxygen tank and a table of
medicines. "But American treatments were not helping me, and I decided I
should go to Cuba. What other choice did I have?"

Soon after she began the medication, she said, her breathing became
easier and her energy returned. In her refrigerator was a box of blue-
and orange-capped vials of the vaccine.

Other cancer patients are following the same unlikely trail. Since
beginning to normalize relations with the United States in 2014, Cuba
has become a hot tourist draw with its unspoiled beaches and vibrant
night life. But the country also has a robust biotechnology industry
that has generated an innovative vaccine called Cimavax. It is part of a
new chapter of cancer treatment known as immunotherapy, which triggers
the body's immune system to attack the disease.

Cimavax is a therapeutic vaccine developed not to prevent cancer, but to
halt its growth and keep it from recurring in patients with
non-small-cell lung cancer. Developed in Cuba and available to patients
there since 2011, it works by targeting a protein called epidermal
growth factor, or E.G.F., that enables lung cancer cells to grow. The
vaccine stimulates the body's immune system to make antibodies that bind
to the E.G.F., thus preventing it from fueling the cancer's growth. It
is also available in Peru, Paraguay, Colombia and Bosnia and Herzegovina.

Last month, Gov. Andrew M. Cuomo of New York announced that the Roswell
Park Cancer Institute, a research and treatment center affiliated with
the University at Buffalo, had received authorization from the Food and
Drug Administration to conduct a clinical trial of Cimavax. It marks the
first time since the Cuban revolution that Cuban and American
institutions have been permitted to engage in such a joint venture, said
Roswell Park's chief executive, Candace S. Johnson.

The trial could take years, but American cancer patients aren't waiting.
Over the past couple of years, dozens have slipped into Havana and
smuggled vials of the vaccine in refrigerated lunchboxes back to the
United States, sometimes not even telling their doctors. Talk about
Cimavax on cancer patient networks online has been escalating steadily
as relations between the two countries have warmed and more patients are
making preparations to go.

"There's no doubt that without this medicine I would be dead," said Mick
Phillips, 69, of Appleton, Wis., who first went to Cuba in 2012 and has
been returning annually ever since. "When we were children, we were
taught that Cubans didn't know what they were doing. Turns out they do."

Despite experiences like Mr. Phillips's, trials in Cuba have shown a
modest benefit over all. In the most recent trial, patients receiving
the vaccine after chemotherapy lived about three to five months longer
than patients who did not receive it. The study, which was published
earlier this year in the peer-reviewed journal Clinical Cancer Research,
also found that vaccinated patients with high concentrations of E.G.F.
in their blood lived even longer.

The United States embargo against Cuba prohibits the importation of most
goods from Cuba, including medication, without a license. American
citizens are now permitted to travel to Cuba if their purpose falls into
one of a dozen categories approved by the Treasury Department, but
seeking medical care is not one of them.

Most patients going to Cuba either fly through a third country such as
Canada, or travel under a general education category called "people to
people." None have declared with customs officials the dozens of vials
of Cimavax they bring back tucked in their backpacks or suitcases.
Stephen Sapp, a public affairs officer for United States Customs and
Border Protection, says there is no record of Cimavax being intercepted
at the United States' border. If it were, it is unclear what might happen.

Under the F.D.A.'s "personal importation policy, some unapproved
medications may be brought into the country if there is not an adequate
alternative available in the United States, or if treatment began in a
foreign country and the amount is limited to a three-month supply. In
addition, the Treasury Department recently established a new general
license enabling American citizens to import Cuban pharmaceuticals under
certain circumstances. But in the case of Cimavax, the regulation has
apparently never been put to the test.

Dr. Malik's son, Nauman, carried 80 vials of the vaccine and a set of
syringes in his backpack when he and his mother flew into Los Angeles
from Cuba in June. Patients generally receive an initial round of four
injections at La Pradera, an international health center that caters
mostly to foreign medical tourists in Havana — two to the arms and two
to the buttocks — and then continue to give themselves periodic
injections at home for up to several months. At the airport, Mr. Malik
wrote on his declaration form that he was carrying medication, but he
said that authorities did not ask what it was.

"I was ready for the discussion, but it just never happened," he said.

Cuban researchers began working on Cimavax in the 1990s, prompted in
part by the high rate of lung cancer in the country. A noncontrolled
study in 1995 produced the earliest published evidence of the
feasibility of inducing an immune response against epidermal growth
factor in patients with advanced tumors, according to a 2010 article
published in Medicc Review, an international journal of Cuban medicine.

Dr. Kelvin Lee, the chairman of immunology at Roswell Park, has been
collaborating with scientists at Cuba's Center of Molecular Immunology
since 2011. He said he hoped the vaccine could be used on other head and
neck cancers and ultimately "to prevent cancer."

Patients in Cuba began receiving the vaccine for free in 2011, and it
has been administered to more than 4,000 patients worldwide, according
to Roswell Park. Lung cancer and immunotherapy researchers are intrigued
by Roswell Park's proposed trial, which would combine the vaccine with a
form of immunotherapy called a checkpoint inhibitor that keeps the
cancer from turning off a patient's immune system. The Roswell trial
intends to use the drug Opdivo, one of four checkpoint inhibitors
approved by the F.D.A.

But the scientists are also reserved in their appraisal of Cimavax, in
part because the Cuban trials were done on a relatively small number of
patients. There is concern that the vaccine has received
disproportionate attention in the flush of warming relations between the
two countries.

"The data is intriguing, but we need to do more definitive studies to
evaluate the benefits," said Justin F. Gainor, a thoracic oncologist at
Massachusetts General Hospital who works on the design of clinical
trials for novel therapeutics. "Right now the body of evidence does not
support using it outside the clinical trial process."

The Cuban health care system has long been recognized for providing high
quality health care. A 2015 report on the Cuban health system by the
World Health Organization noted: "In Cuba, products were developed to
solve pressing health problems, unlike in other countries, where
commercial interests prevailed."

With Cimavax migrating into the United States, those commercial
interests are already coming into play. In Cuba, a four-shot dose of
Cimavax costs up to $100 to manufacture, Dr. Lee said. Mr. Phillips, of
Appleton, Wis., estimates that he pays about $9,000 for his annual
supply of Cimavax, or about $1,500 a dose, which a visiting nurse
administers every two months. Although some patients say the price
recently dropped to about $850 a dose, the total cost of the trip can
easily run more than $15,000, including airfare, lodging at La Pradera
for several nights and a several months supply of the vaccine.

Mr. Phillips, a lifelong smoker who was given a lung cancer diagnosis in
2009, said it was worth every penny. After chemotherapy and radiation,
his cancer returned in 2010.

"Since I have been taking Cimavax it hasn't come back," said Mr.
Phillips, who travels to Cuba via Toronto.

How other patients are doing on Cimavax is difficult to gauge. Dr.
Malik's oncologist declined to be interviewed, saying he did not know
enough about the medication. Several patients said they had not told
their doctors for fear that they would refuse to treat them any further.

"I'm afraid he won't treat me if I am being treated by a Cuban doctor,"
said a 57-year-old woman named Lily who started Cimavax in Cuba in June
and asked not to be identified because she is afraid of consequences for
not declaring it. "I think he'll be afraid of liability or malpractice
issues if he treated me while I was taking something that's not FDA

In the five months since Dr. Malik began taking Cimavax, her experience
has been mixed. Initially, the fluid in her lungs diminished
significantly, giving her renewed energy and allowing her to get around
without her walker. But recently, fluid has begun to build up in her
right lung, and she has grown weak and short of breath. Her son says
she's likely to switch to a new medication soon and stop taking Cimavax. a

"It's not panning out as we'd hoped," he said. "It's really like the
Wild West trying to know what is best to do."

Stories of patients returning from Cuba are met with keen interest on
the online health care social network Inspire, which supports a lung
cancer group of about 53,000 members. They share information about how
to travel under the radar and which size of refrigerated lunchbox is best.

"We got a lot of inquiries," said Judy Gallant, a co-owner of P&G
Travel, which has offices in Ontario and Havana, and is planning trips
to Cuba for half a dozen American patients. "We make it clear we are not
medical people. We just help them connect with people who are."

Some American patients have a new worry: that when President-elect Trump
takes office, he might crack down on Cuba and make it more difficult for
patients to travel there. But Mick Phillips isn't worried.

"I think we're going to be okay," he said. "Trump may do a lot of things
but I don't think he's into preventing people from being able to live."

This story was reported with a grant from the Pulitzer Center on Crisis

Source: A Hot Souvenir From Cuba for Some Americans: Cancer Vaccine -
The New York Times -

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