The late William Halford of Southern Illinois University’s School of Medicine spent his life developing what Hollywood director Agustín Fernández called a herpes “miracle treatment.” Theravax is an experimental herpes vaccine that, in 2013, Halford began testing both on himself and on friends, family, and volunteers. Inside hotel rooms across Illinois, Harford injected Theravax into his patients’ calves. Halford and his patients attested to the vaccine’s success in eliminating or reducing herpes outbreaks. For Fernández, Theravax was a good business opportunity. Silicon Valley libertarian billionaire, Peter Thiel, agreed and invested seven million dollars into Halford and Fernández’s start-up company, Rational Vaccines (one of the many biotech startups Thiel has funded).
To the layperson, seven million dollars may seem like an exorbitant sum. But according to the company’s founders, the cost of filing the vaccine with the FDA ranges from 50 to 100 million dollars, in addition to an up to ten-year waiting period to allow for human trials. Halford and Fernández had neither the money nor the time (Halford was dying from cancer). Without filing any of the necessary paperwork, they conducted human trials on mostly American tourists on the Caribbean island of St. Kitts throughout the summer of 2016. This story of “unethical” and “unregulated” offshore medical research on human subjects was ready-made for the media. Yet no one seems to be asking: why St. Kitts?
St. Kitts, named after Christopher Columbus, was one of the first Caribbean islands settled by Europeans. In the 18th century, St. Kitts became the richest British colony per capita due to its sugar plantations. In 1833, Great Britain outlawed slavery in all of its imperial holdings. St. Kitts, Nevis, and Anguilla were united in 1882 and became an independent state in 1967. While Anguilla remained under British control, St. Kitts and Nevis gained independence in 1983. Today, descendants of African slaves make up the majority of the island’s population.
Like many former slave colonies in the Caribbean, St. Kitts and its sister island Nevis are popular tourist destinations. The islands are also home to several medical universities. That is to say, tourism and the healthcare industry are the islands’ main sources of revenue. Medical research and “medical tourism,” in which people travel to the island to receive more affordable and otherwise superior medical treatment than they would in their home country, also contribute to the islands’ economic growth. In 2015, Dr. Patrick Martin, a native of the island and its Chief Medical Officer (CMO) from 2004 to 2016, spoke out in favor of stem cell tourism.
Martin said that the kind of people interested in stem cell research and regenerative medicine (injecting stem cells to stimulate the body’s own regenerative properties) tend to be wealthy investors. Martin believed stem cell tourism would boost the island’s economy. “[W]e can’t have a ‘one-dimensional tourism package’ of just sand, sea and sun,” he said. But Martin also insisted that the island would only benefit from medical tourism if it occurred within a strong legal and ethical framework.
In June 2016, coinciding with Rational Vaccines’ unregulated herpes research, Martin discovered that the Joseph N. France General Hospital on St. Kitts was conducting illegal and unethical research using human umbilical cord blood plasma. Like Rational Vaccines, the JNF Regenerative Medicine/Stem Cell project did not file the required paperwork with the office of the CMO.
Similar to Halford’s Theravax (an attenuated live virus), the human plasma was neither declared nor exempted from Customs. Further, the JNF Regenerative Medicine/Stem Cell activity was headed by Brazilian expert Silvia Lagrotta, an unregistered and unlicensed doctor. Martin found Lagrotta in the JNF private ward wearing medical scrubs, gloves, and a stethoscope around her neck. Martin asked Lagrotta to cease and desist and leave the premises.
Three days later, Prime Minister Timothy Harris sent Martin on vacation and pre-retirement leave. In July, two police officers delivered a letter from Harris to Martin’s home stating that Martin was retired “with immediate effect.” Martin has since sought legal advice.
Although many attribute Martin’s forced retirement to the stem cell scandal, Wendy Phipps, the Minister of State, insisted that Martin was forced to retire because he was too old. “The retirement age in the civil service is 55 years,” she said, and “Dr. Martin turned 58 last month.” This explanation, however, does not address the urgency to speed-up Martin’s retirement date, originally scheduled for November 2017.
In November 2017, the St. Kitts and Nevis Labour Party’s Dr. Terrance Drew complained that the government had not taken a more active role in both the stem cell/regenerative medicine and herpes trial investigations. Without a full scale investigation, the islands faced serious legal, ethical, and health risks. As Drew stated, “This is plasma, a blood product [that] carries dangerous diseases!” Drew also seemed to believe (despite public statements to the contrary) that Dr. Halford, before his death, in fact “spoke to authorities in St. Kitts and Nevis.” This is “instructive,” he said, implying that the St. Kitts and Nevis government was somehow behind these scandals. While the facts are unclear, certainly, Martin’s forced retirement as well as the government’s lax investigation (turned over to the local police) raise red flags.
One Newsweek article on the scandals claimed that “the location is not the problem,” but it seems as if St. Kitts’ interest in expanding its stem cell and regenerative medicine tourism has opened the floodgates to more than one business. These unregulated ventures have used the island’s facilities to conduct unregulated and unethical medical research. Perhaps new medical tourism will grow the island’s local economy, but without a full investigation and strict legal and ethical measures put into place, American and Canadian businessmen — acting upon their own peculiar interests — will be the ones calling all the shots.