Tech + Health

04.29.14

‘Hero’ Doc Accused of Harvesting Stem Cells in Dirty Basements

Fans of cell therapy company Stamina say the head doctor’s radical therapy is saving lives—but Italian prosecutors say the company is preying on the desperate and the terminally ill.

If you or your child were terminally ill, would you take unimaginable risks for a cure?  According to prosecutors, that’s what a controversial Italian professor, now facing criminal charges for the illegal harvesting, research and manipulation of stem cells, has been banking on for the last eight years.  

According to a criminal complaint filed by prosecutors in Turin, Davide Vannoni, head of cell therapy company Stamina Foundation, preyed on hypochondriacs and terminally ill patients who were desperate for experimental therapies when traditional treatments failed.  He and 19 others, including doctors, ethics committee members, technicians and hospital personnel, are facing pending charges that go well beyond malpractice, including allegations of drug trafficking and corruption in defrauding 60 named patients, not to mention the accusation that Vannoni ran his organization like a Mafia crime boss, according to the complaint.  Stamina Foundation and its subsidiaries Cell Factories, Medestea Stemcells and Biogenesis Research—which are all named in the complaint—had operational offices in Italy, Switzerland, Mexico, and Hong Kong.  They were listed as nonprofit cell therapy groups even though they charged patients up to $50,000 to harvest, manipulate and reinfuse stem cells and up to $12,000 to store them, according to a blistering 69-page court document filed in court last week by Turin prosecutor Raffaele Guariniello and obtained by The Daily Beast. 

Guariniello, who conducted a four-year investigation which resulted in a temporary partial cessation of activity by Stamina in Italy in 2012, is asking a Turin court to order a criminal trial for the 20 defendants, citing horrific circumstances under which Vannoni’s doctors and technicians allegedly did their work.  In one instance in the complaint, Guariniello contends that stem cells were harvested from terminally ill children in the unsterilized basement of a residential house in Turin because the procedure could not be done legally (or ethically) in a hospital. Other treatments, including administering and infusing manipulated stem cells back into patients, were allegedly conducted in the back room of a beauty salon in San Marino, a tiny city-state within Italy’s borders, according to the complaint.  Guariniello also cited in the complaint the use of a bovine serum “with no specified origin” to grow cultures, and contends that there was no real recordkeeping to ensure that the stem cells harvested and manipulated were actually transplanted back to the right recipients.  And, according to the complaint, because Stamina and its subsidiaries were listed as nonprofit, patients were asked to mark treatment payments as “donations” on bank documents.  Guariniello called the treatments “not only useless but also harmful,” in the complaint, and accused Vannoni and the others of using humans “as guinea pigs.” 

In one instance in the complaint, Guariniello contends that stem cells were harvested from terminally ill children in the unsterilized basement of a residential house in Turin.

But one problem with what might seem, if only from the complaint, like a pretty straightforward case is that Vannoni’s patients don’t want him to stop.  Supporters of Stamina, which claims on its Web site through survivor testimonials to have saved the lives of at least 80 patients since 2006, staged a protest last year when a court tried to close down their hospital-based operations after a court injunction. During the protest, patients threw human and pig blood on posters of the prosecutor, health minister and prime minister in front of Rome’s parliament.  They held signs and posters with pictures of young children that Stamina method supposedly saved. And 186 of Vannoni’s patients have reportedly won civil court judgments to allow him to treat them even after his hospital activities were halted. His companies in Switzerland, Hong Kong and Mexico are also apparently still open.

Vannoni, who hangs in the balance between being portrayed as a villain and a cult hero in the Italian media, has also been the subject of a number of Italian television exposes either touting his miracle cures for people with neuro-degenerative diseases like Alzheimer’s and Parkinson’s, or exposing his evil “witchcraft” through scientific testimonials, largely shot in sterile laboratories with scientists in lab coats.  And because there have apparently been no peer reviews or clinical trials of his methods, according to the prosecutor’s complaint, it remains unclear how his treatment works, or if it does at all.  Those who were cured, who are currently under a gag order due to the pending court case, say Vannoni saved their lives.  Some scientists, instead, have published articles saying he almost killed his patients.

According to the court documents, Stamina doctors and technicians often asked attending hospital personnel to “leave the lab” when they had to “add a secret ingredient” to the stem cells.  Doctors who worked with Vannoni in the Brescia hospital, where he was allowed to conduct the controversial treatment, say they had no idea what was going on.  “What the dossier claims is staggering,” Michele De Luca, director of the Centre for Regenerative Medicine, told Science Insider.“It adds a sense of serious danger to the scientific inconsistency of the Stamina method which we were already aware of. We will wait, however, for justice to take its course.”

According to the Turin prosecutor’s complaint, when asked to provide Italy’s health ministry with a set of protocols for the methodology, one of Vannoni’s interns from the University of Turin allegedly drew up a report “with material from Wikipedia that was subsequently processed, integrated and corrected by Vannoni.”  The prosecutor also accuses the group of using propaganda to win over public opinion by using the terms “non-profit,” “humanitarian” and “compassionate” to try to garner public support. He also says that Vannoni preyed on those who had lost hope, because they had “less to lose.”

Those in the scientific community who oppose the use of the Stamina therapy cite the lack of certified clinical trials and logical rationale.  But after the patient protests last year, Italy’s health ministry, backed by a parliamentary vote, consented to fund clinial trials of the method, which have not yet begun and which have become a political hot potato in Italy.  Italy’s health minister, Beatrice Lorenzin, hinted last week that she still supported the clinical trials over the protests of the medical community. “This is a story that has kept Italy and myself in suspense with many concerns and anxieties,” Lorenzin was quoted as saying by local media on Wednesday.  “The matter requires clarification because the victims are the thousands of people who believed they could have a cure.”

In an editorial for Nature magazine, Alison Abbot, who has followed the case from the beginning, argues that validating the Stamina method by conducting clinical tests, which may allow Stamina to continue, sets a dangerous precedent.  “This may seem a good idea, but it is venturing onto dangerous ground. There exist powerful international interests that support clinics offering unproven stem-cell therapies in countries such as Mexico and Uganda,” she says.  “Such countries lack the strict regulatory oversight that prevents the exploitation of desperate patients in Europe and the United States—and the clinics would love to see a regulatory loophole open in a European country.”  She says that Italy must tread carefully not to allow this to happen. 

Scientists against Stamina also sounded off in the notable EMBO Journal describing the Stamina method as illogical.  The method, according to EMBO, “envisages the conversion of mesenchymal stem cells, which normally generate bone, cartilage and adipose tissue, into neurones after brief exposure to ethanol and retinoic acid.”  The method in question, they say, is not only unproven but nonsensical.  “Irrational and unverified stem cell treatments based on methods that are not validated or scientifically documented should not reach patients,” writes Elena Cattaneo, director of the Centre for Stem Cell Research at the University of Milan, Italy.  “Patients can be harmed and killed by medicines that have not been proven to be safe and effective via rigorously controlled clinical trials. The use of medicines that have not been manufactured to the highest possible standards is irresponsible.”

Vannoni could not be reached for comment and his lawyer declined to comment on the pending case, but pointed to a support group, Movimento Stamina—Yes for Life; Yes for Stamina, which posts case studies and scientific documents, and collects donations to support Stamina’s “research” and, quite possibly, its legal bills.  

Vannoni, who is running in European elections on the Io Cambio or I Change political party ticket in May, told reporters on the sidelines of a political rally last weekend that he will abide by whatever the courts decide, but that they are putting lives at risk by stopping his therapy. He also said the court should listen to the voices of parents whose children are alive today because of Stamina therapies, and to those whose family members died without it. Last June, the death of a 2-year-old girl who had been under Stamina treatment, until a court ordered the company to stop, prompted public outrage in Italy by those who support experimental treatment for cases where conventional treatment fails. “It is the first death caused by the legal system,” Vannoni said at the time. “We didn’t kill her, they did.” 

In an interview with Turin newspaper La Stampa after the prosecutor filed his complaint, Vannoni said he was no fraudster. “I’m an honest person,” he said.  “We actually deserve a Nobel Prize in medicine.” A judge will now decide whether Vannoni should face a criminal trial, or if his work gets validated in a clinical trial.