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Story Publication logo January 10, 2018

Cuba Has a Lung Cancer Vaccine. But American Patients Can't Get It Without Breaking the Law.

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The US and Cuba are poised at the alter, prenuptials in hand. But as headlines forecast the fruits...

George Keays, Colorado realtor at La Pradera International Health Center in Havana last October. Image by Desmond Boylan. Cuba, 2017
George Keays, Colorado realtor at La Pradera International Health Center in Havana last October. Image by Desmond Boylan. Cuba, 2017

George Keays is not a rogue kind of a man. A Colorado realtor and grandfather of three, the 65-year-old practices yoga and meditates regularly. But the US government, he says, has left him no choice but to break the law. If, that is, he intends to stay alive.

Keays has stage 4 lung cancer. As his treatment options appeared to be dwindling this fall, he went to Cuba for a vaccine treatment despite a federal law that prohibits Americans from going there for health care. Now, with President Donald Trump’s recent tightening of the regulations governing travel to Cuba, it has become much harder to travel there. But Keays needs more of the vaccine. This spring, he’s going back.

“I am not looking to break the law. But I am not looking to die, either,” Keays declared. “People with stage 4 cancer, like me, should be allowed to try whatever they want to stay alive, whatever they think will work. The last thing they need is the government on your neck over some archaic regulation saying just take what is available here and die.”

Keays has abundant company. In the two years since relations between the US and Cuba were normalized under President Barack Obama, a growing number of lung cancer patients traveled to Cuba for a vaccine called Cimavax, and more recently, a newer vaccine, Vaxira. These patients are an elusive group. None of those who went apparently provided their real reason for going to Cuba when applying for a visa, nor did many of them declare to US customs officials that they were bringing multiple vials of the vaccine into the US on their return. Few even tell their doctors they are taking the injections for fear they will refuse to treat them further.

“I am not looking to break the law. But I am not looking to die, either.” — George Keays, stage 4 lung cancer patient

“I can only see it as compromising him because now he has a patient on a drug that is not approved by the FDA,” said a patient in Florida named Larry, who asked that his last name not be used. Larry has gone to Cuba twice for the vaccine — both times without telling his doctor because, “He might be afraid he would be sued, or he might stop treating me.”

Just how effective are the vaccines they’re smuggling into the country in their small refrigerated lunch boxes is unclear. Neither of the vaccines prevents cancer; rather, they are a kind of immunotherapy that prompts the body’s immune system to battle the disease in patients with non-small cell lung cancer. In January, the Roswell Park Comprehensive Cancer Center in Buffalo, New York, launched a clinical trial of Cimavax with Cuba’s Center of Molecular Immunology, which developed the vaccine. It is the first such joint venture between the two countries since the Cuban revolution.

Roswell is now doing research to determine if they want to do a similar trial with Vaxira. It will take years for either of the drugs to receive any final approval.

For many patients, including some who were not accepted into the Roswell trial, travel to Cuba has become a much-talked-about option. So popular has the practice become that patients on internet support groups routinely trade anecdotes and travel tips about their Cuban journeys. Until, that is, Trump threw a wrench into the process.

The change in regulations governing travel to Cuba that went into effect in November altered one of the most popular categories of travel to Cuba initiated by Obama, known as “people-to-people,” which allowed travelers to go to Cuba on their own. That’s how many Americans have been quietly going to the island for medical care, even though doing so is prohibited under the US embargo against Cuba. Now, people in this category must travel with an organization and have a guide present.

Americans can continue to travel on their own to Cuba for the purpose of professional research or to provide “support for the Cuban people.” But given that travelers in those categories are required to maintain a full schedule of activities, it’s likely that neither will be a good option for cancer patients.

At the La Pradera International Health Center in Havana, where most American cancer patients go for treatment, Dr. Anabely Estévez García felt the impact of the new regulations in her inbox as soon as Trump announced back in June that the changes were in the works. American patients began canceling their plans in a flood.

 Dr. Anabely Garcia at La Pradera. Image by Desmond Boylan. Cuba, 2017.
Dr. Anabely Garcia at La Pradera. Image by Desmond Boylan. Cuba, 2017.

“We can not go at this time,” a Texas man emailed García on the day of Trump’s announcement. “President Trump changed everything today. It is not possible to go directly from here. Keep us in touch.”

A patient in New York on the brink of travel wrote that she had decided “to wait a little longer. Now, it will be harder to get there as our President has made it impossible to travel alone.”

Nancy Kelly, a 71-year-old California patient who traveled to Cuba for Vaxira this past spring, emailed that she was worried about the new regulations, too. How would she replenish her vaccine supply when it ran out in October? She decided not to go herself but sent a friend to Cuba to pick up more for her.

“It was important to get back to Cuba before Trump’s restrictions went into effect,” sighed Kelly. “With the new restrictions, I would need to go through a third country. The problem is that the vaccine has to be refrigerated, so, if you were on a long flight, that was going to be a problem.”

The tighter regulations are only part of what is keeping patients from going. Another factor is the State Department advisory issued this past September warning American citizens not to go to Cuba due to alleged assaults against American Embassy staff. Investigators have yet to determine exactly who or what was behind the assaults, and the staff in Havana has been significantly reduced. For some travelers, it’s all just too much.

Since relations between the US and Cuba were normalized at the end of 2014, the number of patients going to the plush La Pradera clinic at the city’s edge had risen steadily. In 2016, 50 Americans came for treatment. Last year, the number of inquiries about the vaccines tripled over the previous year while 47 patients had already made the journey to Cuba in the first eight months of 2017, according to García. Now, the numbers have plateaued.

La Pradera International Health Center. Image by Desmond Boylan. Cuba, 2017.
La Pradera International Center. Image by Desmond Boylan. Cuba, 2017.

“There are many patients who are suitable for treatment but who do not come for political reasons,” said García, seated in a treatment room at La Pradera this fall. “As a physician, I feel very bad because I believe our vaccine is a good treatment that can extend these people’s lives.”

Because their own doctors are often not involved, patients wanting to go to Cuba must make arrangements themselves. First, they get in touch with La Pradera either through email or one of a number of medical tourism agencies in the US or in Canada. They then send their medical records for evaluation by La Pradera physicians who determine if they are eligible for one of the vaccines, and if so, which one.

Under the Obama-era regulations, accepted patients usually informed the airlines issuing their visas that they were going for educational purposes or under the general people-to-people category. Questions were rarely asked and most flew directly to Cuba.

Patients stay at the La Pradera clinic, a resortlike facility with a swimming pool and fountains, for four days, during which they receive their first of several doses of the vaccine. Each dose consists of four injections — two to the arms and two to the buttocks. One dose costs about $860, so the total cost of the trip, including airfare, lodging and a supply of the medication to take back home, can run well over $10,000.

Dr. Anabely Estévez García is pictured with a patient. Image by Desmond Boylan. Cuba, 2017
Dr. Anabely Estévez García is pictured with a patient. Image by Desmond Boylan. Cuba, 2017.

At P&G Travel in Ontario, long one of the more popular agencies among Americans for booking travel to Cuba, the numbers are both up and down. Since Trump announced in June that he would be reversing aspects of the Obama administration’s overtures to Cuba, the number of Americans booking travel directly from the US to Cuba through the agency has plummeted by 60 percent. Instead, they’re now going through third countries just like they used to do before Obama’s normalization of relations. Since June, the number of bookings by Americans going to the island from countries other than the US has increased by 30 percent, according to Tathiana Gonzalez, the agency’s Cuba travel specialist.

“You’re either going to go or not go,” said Gonzalez. “When you’re given a month to live, you go. It’s kind of basic.”

What they are going for is part of the new wave of immunotherapy treatment that works by triggering a patient’s immune system to fight cancer. Cimavax, for example, stimulates the immune system to make antibodies that bind to a protein called epidermal growth factor, or EGF, that cancer cells need to grow, effectively starving the cancer. Vaxira is somewhat different; it triggers an immune response against a molecule specific to several cancers and is intended to ultimately block the cancer’s growth. Only patients who have already received chemotherapy are eligible for the vaccines.

While Cuba is often recognized for its pristine beaches and throbbing rumbas, it is also home to a burgeoning biotechnology industry. Prompted by the country’s high rate of lung cancer, researchers began work on a lung cancer vaccine back in the mid-1990s. In the most recent of several Cuban trials, patients receiving Cimavax lived about three to five months longer than those who did not. Available to Cubans for free since 2011, it has been given to more than 5,000 patients worldwide.

“When you’re given a month to live, you go. It’s kind of basic.”— Tathiana Gonzalez, P&G Travel

Cimavax is currently available in Cuba, Colombia, Peru, Bosnia-Herzegovina and Paraguay. Vaxira, which one Cuban clinical trial indicates can extend life by up to two months, is currently undergoing more testing in Argentina. It is available in that country and in Cuba.

Roswell scientists began collaborating with Havana’s Center of Molecular Immunology, which developed the vaccines, in 2011, and scientists from both countries have worked in one another’s laboratories frequently over the years. In the Roswell trial, Cimavax is being combined with a checkpoint inhibitor, which blocks proteins on cancer cells, called Opdivo.

While talk of Cimavax has circulated in American medical circles for years, much less is known about Vaxira. Roswell researchers are currently doing preclinical studies of Vaxira in animals to determine if the vaccine merits a possible human trial. Dr. Igor Puzanov, director of the early phase clinical trials program at Roswell, said that it could take up to a year before a decision can be made on whether to proceed.

“We know what the vaccine is supposed to do,” he said. “It’s just too early to say if it does it.”

Meanwhile, at the Center of Molecular Immunology, scientists are now focused on taking Cimavax to a next step. They are working to extend patients’ survival rate by identifying markers in those who are responsive to the vaccine. Patients with high concentrations of the EGF protein, for example, have been shown to be more responsive to the vaccine than those who do not. Camilo Rodriguez, a clinical researcher at the center who has worked on Cimavax for 15 years, says he believes that eventually, the vaccine might be used on a host of cancers.

“We feel that the vaccine could be very effective against prostate cancer, for example, because those patients often have a high degree of EGF and that is related to the spread of cancer,” said Rodriguez, seated in his laboratory. “Eventually, we feel this could be useful in all kinds of cancer affecting the head, neck, bladder and prostate.”

Camilo Rodriguez is a clinical researcher in Havana who has worked on Cimavax for 15 years. Image by Desmond Boylan. Cuba, 2017.
Camilo Rodriguez is a clinical researcher in Havana who has worked on Cimavax for 15 years. Image by Desmond Boylan. Cuba, 2017.

American doctors are not so sure. While some are cautiously optimistic about Cimavax and await the outcome of the Roswell trial with interest, others complain that the vaccine has been oversold and is in sore need of further study. Dr. Robert Doebele, associate professor of medical oncology at the University of Colorado Denver and a senior editor of the American Association for Cancer Research’s journal Clinical Cancer Research, recalls sitting in a meeting with a dozen other oncologists discussing the best way to market a drug. Someone in the room called out, “Do whatever Cimavax does!”

“Eventually, we feel this could be useful in all kinds of cancer affecting the head, neck, bladder and prostate.” — Camilo Rodriguez, clinical researcher

“We all let out a collective groan,” said Doebele, who is George Keays’ oncologist. “It was hilarious. The fact is that I spend several hours a month answering questions from my patients about this. It’s very prominent on the internet and patients are understandably desperate to learn about it. But the fact is that we just don’t know if this works yet.”

Dr. Roy S. Herbst, chief of medical oncology at Yale University and a nationally recognized expert in the treatment of lung cancer, shares those reservations. Herbst says that “without seeing new stats, it’s not that impressive.” For the moment, he added, “I am not too worried about people not being able to go to Cuba.”

Like several other doctors of the patients interviewed for this story, Doebele advised Keays not to go to Cuba for the vaccine. One reason for that is that Keays is currently taking Tagrisso, a standard therapy for non-small cell lung cancer. Doebele is concerned that if Keays shows improvement while taking that and one of the Cuban vaccines, it will be impossible to tell which medication was responsible. But Doebele has other worries.

“My biggest concern is safety because of the lack of oversight and regulation. I can’t control what he does; I don’t even know where he’s getting it. Was it even a legitimate clinic where he got it?” said Doebele. “I thought I’d talked him out of it.”

But he hadn’t. Keays did apply to participate in the Roswell trial, as Doebele suggested, but he was put on the waiting list. He became frustrated that he might wind up in the placebo group in the study, and so he decided “to go right to the front of the line. Cuba.”

“My biggest concern is safety because of the lack of oversight and regulation.” — Dr. Robert Doebele, associate professor of medical oncology, University of Colorado Denver

Keays arrived at the La Pradera clinic in October and was advised that the vaccine most suited to his cancer was Vaxira. After consulting with his family doctor, Boulder internist William L. Blanchet, who was traveling with him, Keays received his first dose.

“Twenty minutes after I received it, I felt a little tired, but that was it,” said Keays. “The next day, I went for an hour run. I felt great.”

If Keays was impressed by the professionalism of the doctors, Blanchet was even more so.

“On paper, this looks very promising,” Blanchet said of the vaccine. “It resonates as being medically sound and potentially a major addition. It’s too soon to recommend it to patients, but I would make them aware of it and let them make the decision. If I was diagnosed with stage 4 cancer, I would definitely go down and have this be part of my therapy.”

One of the other patients at La Pradera when Keays was there was Eduardo Sanchez, of Spain, a lean man with graying hair. Diagnosed with advanced stage 4 lung cancer, Sanchez said he, too, had exhausted most of the treatments available to him. Like most American patients, he learned much of what he knew of the Cuban vaccines on the internet.

“Unfortunately, in Spain, there is no information about the Cimavax or the Vaxira,” he said. “It’s too early for me to say, but I am very hopeful.”

For advanced stage cancer patients like Sanchez and Keays, going to Cuba can be difficult in itself. The trip is tiring and can be daunting for those for whom the treatment may be viewed as something of a last resort. Now, American patients face an even higher hurdle in the new and somewhat confusing regulations. The question many patients are wrestling with is how to get in and out of the country without getting caught, given the likelihood of greater scrutiny.

Over the past two years, it appears that no one has been apprehended. The US Food and Drug Administration’s “personal importation policy” allows some unapproved medications to be brought into the country, provided there is not an adequate alternative available in the US and the amount does not exceed a three-month supply. But spokesmen for both the FDA and US Customs and Border Protection say there is no record of either of the Cuban vaccines having been brought into the country or seized at the border.

Eduardo Sanchez, of Spain, diagnosed with advanced stage 4 lung cancer, says he has exhausted most of the treatments available to him. Image by Desmond Boylan. Cuba, 2017.
Eduardo Sanchez, of Spain, diagnosed with advanced stage 4 lung cancer, says he has exhausted most of the treatments available to him. Image by Desmond Boylan. Cuba, 2017.

Just how to bring the vaccine into the US is a hot topic on the online health care social network, Inspire, which supports a lung cancer group of about 53,000 members. Judy Ingels, 74, is one of them. Diagnosed with stage 4 lung cancer in 2015, Ingels went on Tarceva and her tumor shrunk somewhat. After she saw a CNN report on Cimavax at the end of 2016, she decided to go to Cuba while she was relatively well and still able to do so. Last spring, she and her family traveled from their home in Santa Rosa, California, to Havana, where she received her first treatment of the vaccine. All told, the trip cost about $16,000. That she was breaking the law did not trouble her in the slightest.

“I just didn’t get hung up on it,” said Ingels. “My husband said, ‘When they ask what your purpose is, just don’t mention anything about medicine.’”

Ingels had no trouble carrying an eight-month supply of Cimavax back into the US in a hand-held refrigerated lunch bag. When she told the Transportation Security Administration agent in Florida that she was carrying a vaccine, he opened her bag and poked around but asked no questions.

In the months that followed, Ingels’s tumor shrunk perceptibly, a fact that she attributes to Cimavax. Now, however, her supply has run out and she wants more. Presuming that she cannot travel with a guided group, given her purpose, she is considering hiring one of several professional “mules” who will fly to Cuba to get the vaccine for a fee. Two of them contacted by PRI declined to be interviewed.

“We’re weighing the options,” said Ingels. “We might travel ourselves through the Bahamas. But I have also talked to an individual who has offered to do this.”

Nancy Kelly, who had a friend travel to Cuba on her behalf earlier this year, was considering a return trip. But when a scan this fall showed that her tumor is growing, she changed her plans — at least for the moment. The change in her circumstance has not dimmed the retired administrative judge’s anger at the government’s imposition of limitations on American patients’ ability to seek the treatment they want.

“I think it’s absolutely outrageous. What Trump has done makes it so much more difficult to go,” said Kelly. “The restrictions that do not permit doctors in different countries to corroborate to help save lives is absolutely terrible.”

  California patient Nancy Kelly. Image by Ali Budner. United States, 2017.
California patient Nancy Kelly. Image by Ali Budner. United States, 2017.

Keays is running into a similar problem since a recent scan showed that a mass on his liver is growing. Doebele, his oncologist, believes that means that neither the Vaxira nor the Tagrisso is working. Doebele has suggested Keays go off the Vaxira, in part, so that he might qualify for other treatments, but Keays continues to have faith. He’s planning on returning to Havana in the spring for more of the vaccine. Keays intends to apply for a visa under the category of “professional research” arguing that he is a guinea pig for the Vaxira vaccine. He has become, after all, something of an expert on the subject. Over the past two years, he’s tried a wide variety of treatments: two targeted therapies, multiple forms of radiation and a lot of meditation. He’s been on Vaxira now for two months.

In between doctor’s appointments, Keays has been working on a letter to the chairman of the US Senate Committee on Foreign Relations, hoping he might intervene on patients’ behalf. He’s getting other patients to write, too.

George Keays is pictured. Image by Desmond Boylan. Cuba, 2017.
George Keays is pictured. Image by Desmond Boylan. Cuba, 2017.

“I intend to do whatever I can to expose how these restrictions steal the hope, and possibly, the life, from patients suffering with terminal cancer, as well as other sicknesses that might benefit from Cuba’s advances in medicine,” declared Keays. “The ignorance in this new policy is astounding.”

In the meantime, for patients disheartened by an American government and doctors who seem to offer them only discouragement regarding Cuba, there is one source of potential support: travel agents like Tathiana Gonzalez in Ontario.

Unaffected by the US regulations, Gonzalez routinely forwards dozens of American patients’ medical records to La Pradera, on their behalf, to see if they qualify for one of the vaccines. It’s the only instance in which she gets involved in her clients’ medical needs because, she says, the process is so stressful. She’s the first to admit that she’s no medical researcher, but she notices that some of the cancer patients that she’s helped get to Cuba have lived for years. Like her clients, she waits anxiously for a response from the Cuban doctors: Are they accepted to go, or not?

“It’s such an emotional roller coaster,” exclaimed Gonzalez. “If they’re not accepted, I cry because their cancer is so advanced. If they are accepted, I rejoice! I say, ‘You’re going! You are going to Cuba!’”


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