Cuba has a vaccine against lung cancer. Many patients from the USA UU They can not get it without breaking...
Cuba has a vaccine against lung cancer. Many patients from the USA UU They can not get it without breaking the law
George Keays is not a rogue man. A Colorado real estate agent and a grandparent of three, 65 years old, practice yoga and meditation ...
George Keays is not a rogue man. A Colorado real estate agent and grandfather of three, the 65-year-old, practices yoga and meditates regularly.by Sally Jacobs
But the government of the United States, he says, has left him no choice but to break the law. Yes, that is, pretend to be alive.
Keays has stage 4 lung cancer. As his treatment options seemed to be declining this fall, he went to Cuba for a vaccine treatment. despite a federal law that prohibits Americans from going there to receive medical care.
Now, with the recent tightening of regulations governing travel to Cuba by President Trump, it has become much harder to travel there. But Keays needs more of the vaccine. This spring, he will come back."I'm not looking to break the law, but I'm not looking to die either," Keays said.
"People with stage 4 cancer, like me, should be allowed to try whatever they want to stay alive, what they think will work. "The last thing they need is the government of your neck on an archaic regulation that says simply take what is available here and die."
Keays has abundant company. In the two years since relations between the United States 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 new vaccine, Vaxira.
These patients are an elusive group. None of those who came appeared to provide their real reason for going to Cuba when they applied for a visa, and many of them did not declare to US customs officials that they were taking several vials of the vaccine to the United States upon their return.
Few tell their doctors they are taking the injections for fear they will refuse to continue treating them.
"I can only see it as a compromise for him because he now has a patient with 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 could be afraid of being sued or stopped treating me."
It is not clear how effective vaccines are that smuggle the country into their small refrigerated lunch boxes.
None of the vaccines prevents cancer; rather, they are a type of immunotherapy that stimulates the body's immune system to fight 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 the Molecular Immunology Center of Cuba, which developed the vaccine. It is the first joint venture of this kind between the two countries since the Cuban revolution.
Roswell is now investigating to determine if they want to do a similar test with Vaxira. It will take years for any of the medications to receive final approval.
For many patients, including some who were not accepted in the Roswell trial, traveling to Cuba has become a much talked about option.
The practice has become so popular that patients in Internet support groups routinely share anecdotes and travel tips about their trips to Cuba. Until, that is, Trump threw a key in the process.
Important changes for patients going to Cuba.
The change in regulations governing travel to Cuba that came into force in November altered one of the most popular categories of travel to Cuba initiated by Obama, known as "person to person," which allowed travelers to go to Cuba for their travel. account.
This is how many Americans have been going silently to the island to receive medical attention, although doing so is prohibited under the United States embargo against Cuba. Now, people in this category must travel with an organization and have a guide present.
The Americans can continue traveling on their own to Cuba with the purpose of carrying out a professional investigation or to offer "support to the Cuban people".
But since travelers in these categories must maintain a full schedule of activities, none is likely to be a good option for cancer patients.
At the La Pradera International Health Center in Havana, where most American cancer patients receive treatment, Dr. Anabely Estévez García felt the impact of the new regulations in her inbox as soon as Trump announced in June that the changes were underway. American patients began canceling their plans in a flood.
"We can not go right now," a Texas man sent an email to Garcia 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 about to travel wrote that she had decided to "wait a little longer". Now it will be more difficult to get there, since our President has made it impossible to travel alone. "
Nancy Kelly, 71, a patient from California who traveled to Cuba for Vaxira last spring, sent her an email saying she was also worried about the new regulations.
How would you replenish your vaccine supply when it runs out in October? She decided not to go alone, but she sent a friend to Cuba to pick up more for her.
"It was important to return to Cuba before Trump's restrictions came into force," Kelly sighed.
"With the new restrictions, I would have to go through a third country. The problem is that the vaccine must be refrigerated, so if you travel on a long flight, that would be a problem. "
The strictest regulations are only part of what prevents patients from going. Another factor is the State Department's warning issued last September that warns US citizens not to go to Cuba because of alleged attacks against US embassy personnel.
Researchers have yet to determine exactly who or what was behind the assaults, and the staff in Havana has been significantly reduced. For some travelers, everything is too much.
Since the relations between the US were normalized UU And Cuba at the end of 2014, the number of patients who went to the luxurious clinic of La Pradera on the outskirts of the city had increased steadily.
In 2016, 50 Americans came for treatment. Last year, the number of consultations on vaccines tripled compared to the previous year, while 47 patients had already made the trip to Cuba in the first eight months of 2017, according to García. Now, the numbers have stalled.
"There are many patients who are fit for treatment but who do not come for political reasons," Garcia said, sitting in a treatment room in La Pradera this fall.
"As a doctor, I feel very bad because I think our vaccine is a good treatment that can extend the lives of these people."
Because their own doctors often do not participate, patients who want to go to Cuba must make the arrangements themselves.
First, they contact La Pradera via email or one of several medical tourism agencies in the US. UU Or in Canada.
They then send their medical records so that the doctors at La Pradera can evaluate if they are eligible for one of the vaccines and, if so, which one.
Under Obama-era regulations, accepted patients usually informed airlines that issued their visas that were for educational purposes or in the general category from person to person. Questions were rarely asked and most of them flew directly to Cuba.
The patients remain in the La Pradera clinic, a tourist-type facility with pool and fountains, for four days, during which they receive the first of several doses of the vaccine.
Each dose consists of four injections: two in the arms and two in the buttocks. A dose costs approximately $ 860, so the total cost of the trip, including airfare, lodging and the supply of the medication to take home, can cost more than $ 10,000.
At P & G Travel in Ontario, one of the most popular agencies among Americans who book trips to Cuba, the numbers go up and down.
Since Trump announced in June that it would reverse some aspects of the Obama administration's proposals to Cuba, the number of Americans traveling directly from the US. UU Cuba has been reduced by 60% through the agency.
Instead, they are now going through third countries as they used to do before the normalization of Obama's relations.
Since June, the number of reservations of Americans traveling to the island from countries other than the United States. UU It has increased by 30%, according to Tathiana González, the travel specialist for Cuba at the agency.
"Either you will go or you will not go," Gonzalez said. "When they give you a month to live, you go, it's a bit basic."
What they are looking for is part of the new wave of immunotherapy treatment that works by activating a patient's immune system to fight cancer.
Cimavax, for example, stimulates the immune system to produce antibodies that bind to a protein called epidermal growth factor, or EGF, which cancer cells need to grow, effectively killing the cancer.
Vaxira is something different; It triggers an immune response against a specific molecule for several cancers and is designed to block the growth of cancer. Only patients who have already received chemotherapy are eligible for vaccines.
Must read:
Cubans investigate a vaccine against lung cancer
While Cuba is often recognized for its pristine beaches and pulsating rumbas, it is also home to a thriving biotech industry. Following the high rate of lung cancer in the country, researchers began working on a vaccine against lung cancer in the mid-1990s.
In the most recent of several Cuban trials, patients who received Cimavax lived three to five months longer than those who did not. Available to Cubans for free since 2011, it has been administered to more than 5,000 patients around the world.
Cimavax is currently available in Cuba, Colombia, Peru, Bosnia-Herzegovina and Paraguay. Vaxira, that a Cuban clinical trial indicates that it can extend life for up to two months, is currently conducting more tests in Argentina. It is available in that country and in Cuba.
The Roswell scientists began collaborating with the Molecular Immunology Center of Havana, which developed the vaccines, in 2011, and scientists from both countries have worked in other laboratories frequently over the years.
In the Roswell trial, Cimavax is being combined with a checkpoint inhibitor, which blocks proteins in cancer cells, called Opdivo.
While rumors about Cimavax have circulated in American medical circles for years, much less is known about Vaxira. The Roswell researchers are currently conducting preclinical studies of Vaxira in animals to determine if the vaccine deserves a possible human trial.
Dr. Igor Puzanov, director of the early phase clinical trial program at Roswell, said it could take up to a year before a decision can be made about whether to proceed or not.
"We know what the vaccine is supposed to do," he said. "It's too early to say if it does."
Meanwhile, at the Center for Molecular Immunology, scientists are now focused on taking Cimavax to the next step. They are working to expand the survival rate of patients by identifying markers in those who respond to the vaccine.
Patients with high concentrations of the EGF protein, for example, have been shown to be more sensitive to the vaccine than those who do not.
Camilo Rodriguez, a clinical researcher at the center who has worked at Cimavax for 15 years, says he believes that, over time, the vaccine could be used in a large number of cancers.
"We believe 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, sitting in his laboratory.
"Finally, we believe that this could be useful in all types of cancer that affect the head, neck, bladder and prostate.
American doctors are not so sure. While some are cautiously optimistic about Cimavax and look forward to the outcome of the Roswell trial, others complain that the vaccine has been oversold and that further study is necessary.
Dr. Robert Doebele, associate professor of medical oncology at the University of Colorado-Denver and principal editor of the American Association for Cancer Research, recalls being in a meeting with a dozen other oncologists who talk about the best way to market a drug. Someone in the room shouted: "Do what Cimavax does!"
"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 my patients' questions about this, it's very prominent on the Internet and patients are understandably desperate to meet him, but the fact is that we still do not know if this works."
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 statistics, it's not that impressive". For the moment, he added, "I'm not worried that people can not go to Cuba."
Like 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 by taking that and one of the Cuban vaccines, it will be impossible to know which medication was responsible. But Doebele has other concerns.
"My biggest concern is security due to the lack of supervision and regulation. I can not control what he does; I do not even know where he is getting it. Was it even a legitimate clinic where he got it? "Doebele said. "I thought I had convinced him not to do it."
But he had not done it. Keays applied to participate in the Roswell trial, as suggested by Doebele, but was placed on the waiting list.
He was frustrated that he could end up in the placebo group in the study, so he decided to "go straight to the front of the line." Cuba."
Keays arrived at the La Pradera clinic in October and was informed that the most suitable vaccine for 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," Keays said. "The next day, I left for an hour running. I felt very well ".
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 medically sound and potentially an important addition. It is too early to recommend it to patients, but I would warn them and let them make a decision. "If I was diagnosed with stage 4 cancer, it would definitely go down and be part of my therapy."
One of the other patients in La Pradera, when Keays was there, was Eduardo Sanchez, from Spain, a thin man with graying hair.
With a diagnosis of advanced stage 4 lung cancer, Sanchez said he had also exhausted most of the treatments available to him. Like most American patients, he learned a lot from what he knew about the Cuban vaccines on the internet..
"Unfortunately, in Spain, there is no information about Cimavax or Vaxira," he said. "It's too early for me to say it, but I have high hopes."
Questions about how to recover the vaccine.
For patients with advanced cancer such as Sánchez and Keays, going to Cuba can be difficult in itself. The journey is exhausting and can be discouraging for those for whom treatment can be considered a last resort.
Now, American patients face an even greater hurdle in the new and somewhat confusing regulations. The question that many patients are struggling with is how to get in and out of the country without getting caught, given the possibility of greater scrutiny.
In the last two years, it seems that no one has been arrested. The United States Food and Drug Administration's "personal import policy" allows some unapproved drugs to be introduced into the country, as long as there is no adequate alternative available in the United States and the quantity does not exceed a supply of three months.
But the spokespersons of the FDA and the US Customs and Border Protection Office. UU They say there are no records that any of the Cuban vaccines have been introduced in the country or have been confiscated at the border.
The issue of how to bring the vaccine to the US UU It is a hot topic in the online health care social network, Inspire, which supports a lung cancer group of approximately 53,000 members. Judy Ingels, 74, is one of them. Diagnosed with stage 4 lung cancer in 2015, Ingels continued with Tarceva and her tumor narrowed a bit.
After seeing a CNN report on Cimavax in late 2016, he decided to go to Cuba while he was relatively well and could still do so.
Last spring, she and her family traveled from her home in Santa Rosa, California, to Havana, where she received her first vaccine treatment. All said, the trip costs around $ 16,000. That she was breaking the law did not bother her in the least.
"I just did not obsess about it," Ingels said. "My husband said: 'When they ask you what your purpose is, just do not mention anything about the medicine.'"
Ingels had no problem bringing an eight-month supply of Cimavax to the US. UU 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 his bag and searched but did not ask questions.
In the months that followed, Ingels' tumor shrank significantly, a fact she attributes to Cimavax. Now, however, your supply has run out and you want more.
Assuming you can not travel with a guided group, given your purpose, you are considering hiring one of the many professional "mules" that will travel to Cuba to receive the vaccine for a fee. Two of them contacted by the PRI declined to be interviewed.
"We are weighing the options," Ingels said. "We could travel to ourselves through the Bahamas, but I have also spoken with an individual who has offered to do this."
Nancy Kelly, who had a friend who was traveling to Cuba on her behalf, was considering a return trip. But when a scan last fall showed that her tumor is growing, she changed her plans, at least for the time being.
The change in their circumstances has not tempered the wrath of the administrative judge removed by the imposition by the government of limitations on the ability of American patients to seek the treatment they desire.
"I think it's absolutely outrageous, what Trump has done makes it much harder to go," Kelly said. "The restrictions that do not allow doctors from different countries to corroborate to help save lives are absolutely terrible."
Keays is faced with a similar problem since a recent scan showed that a mass in his liver is growing. Doebele, his oncologist, believes that this means that neither Vaxira nor Tagrisso are working.
Doebele has suggested that Keays leave the Vaxira, in part, so that he can qualify for other treatments, but Keays still has faith. He is planning to return to Havana in the spring for more of the vaccine.
Keays intends to apply for a visa in the category of "professional research" arguing that he is a guinea pig for the Vaxira vaccine. He has become, after all, an expert on the subject.
In the last two years, he has tried a wide variety of treatments: two targeted therapies, multiple forms of radiation and a lot of meditation. He has been in Vaxira for two months.
Between appointments with the doctor, Keays has been working on a letter addressed to the chairman of the US Senate Foreign Relations Committee. UU., With the hope that I can intervene on behalf of patients. It is also causing other patients to write.
"I intend to do everything possible to expose how these restrictions rob hope and possibly the lives of patients with terminal cancer, as well as other diseases that could benefit from advances in Cuban medicine," Keays said. "Ignorance in this new policy is amazing."
Meanwhile, for patients discouraged by a US government and doctors who seem to offer only discouragement about Cuba, there is a potential source of support: travel agents like Tathiana Gonzalez in Ontario.
Without being affected by US regulations. UU., Gonzalez routinely sends dozens of US patient medical records to La Pradera, on his behalf, to see if they qualify for one of the vaccines.
It is the only case in which he gets involved in the medical needs of his clients because, he says, the process is very stressful.
She is the first to admit that she is not a medical researcher, but she realizes that some of the cancer patients she has helped to reach Cuba have lived for years. Like his clients, he anxiously awaits the response of Cuban doctors: Is it accepted that they go or not?
"It's such an emotional roller coaster," exclaimed Gonzalez. "If they are not accepted, I cry because their cancer is very advanced, if they are accepted, I am glad! I say, 'You are going! You are going to Cuba!
This story was reported with a grant from the Pulitzer Center on Crisis Reporting. It was originally published on PRI.org. Its content is independent of USA TODAY.
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