Claims involving a former president, the protection of big pharma profits, and cells from umbilical cord blood are at the centre of a legal battle that stretches between South Africa and the US.

The US Food and Drug Administration (FDA) portrays South African Van Rooyen and his ex-partner, American-born Laura Brown, as criminals who peddled bogus treatments to sick patients.

But Van Rooyen alleged their lives were derailed after the FDA unfairly targeted them as part of a plot to suppress new medical treatments that threatened the profits of big pharmaceutical companies.

Van Rooyen said in court papers that the US’s legal action against him, which he claimed was not carried out in good faith, left him with a ruined reputation, financial problems and struggling to get work in South Africa.

The US wanted to extradite Van Rooyen and Brown, and their legal battle to prevent this was previously linked to that of Nello Quagliani, also based in South Africa and accused of smuggling drugs to the US.

Last week, Daily Maverick reported that Quagliani was only surrendered to US authorities on 15 September this year – 19 years after he was initially arrested. Daily Maverick now unpacks what happened to Van Rooyen and Brown.

Wanted in the US

Between 2002 and 2006, Van Rooyen and Brown ran a business called Biomark International. A US indictment said this company had addresses in Atlanta, Canada and Florida. The couple sold stem cells and stem cell injections to people with chronic diseases, including multiple sclerosis.

The indictment states that Van Rooyen and Brown got the stem cells from blood banks in Texas before shipping them to the Biomark offices in Florida.

Brown, the FDA alleges, claimed customers could be cured by injecting stem cells from umbilical cord blood, and that she and Van Rooyen injected each customer in the abdomen with 1.5 million stem cells.

A treatment cost between $10,000 and $32,000.

“The stem cells acquired by Van Rooyen and Brown were solely intended for use in laboratory research on animals and were never intended to be used on humans,” the FDA website alleges.

“Van Rooyen and Brown misled their customers by convincing them that the treatments would cure their diseases. Van Rooyen and Brown received at least $1.2-million in proceeds from this scheme, which they took from Biomark and transferred to their own personal joint bank account.”

In 2006 an indictment was filed in the US against Van Rooyen and Brown, who had based themselves in South Africa.

Relentless pursuit

Brown died unexpectedly in July 2011. She was 35. According to a 2017 affidavit, Van Rooyen believed her death “was effectively caused by the enormous and unrelenting pressure generated by the [FDA’s] indictment, the ongoing persecution and her feeling of ultimate betrayal by the country of her birth”.

Van Rooyen is still listed on the FDA’s website as a “most wanted” fugitive.

It was previously found that Van Rooyen could be extradited to the US. But a subsequent finding means that South Africa will not force him to go to the US to face legal action relating to the FDA’s assertions.

In a February 2019 letter to Van Rooyen, which Daily Maverick has seen, justice and constitutional development minister at the time, Michael Masutha, wrote: “I hereby wish to inform you that I have favourably considered your petition, and have decided not to surrender you to the United States of America to stand trial on various charges.”

Creating a company

Several years ago, Van Rooyen and Brown made news headlines. But in recent years the matter was no longer playing out in public and so it was not clear what had happened to Van Rooyen.

It has since emerged that, ahead of the 2019 decision not to send him to the US, Van Rooyen was involved in years of legal proceedings.

Born in Cape Town in 1962, he graduated from the University of Cape Town in 1986, after which he ran a sports marketing and events company for 15 years.

In 2001 a friend invited him to the US to get involved in a business linked to stem cell research. The following year he met Brown, who shared his “passion and vision for stem cells”. In 2002, along with three others, they formed the company Biomark International LLC.

According to Van Rooyen’s affidavit, neither he nor Brown represented themselves as having “medical or scientific credentials”.

He said all patients had to sign a two-page consent form, which stated “that the treatment was not FDA approved” and was viewed as experimental and not as a cure.

“Stem cell therapy and research is as much a part of mainstream medical research … only positive results were achieved from the therapy with no negative side effects and no patient complaints.”

George W’s criticism

Van Rooyen’s affidavit also said, at a time when stem cell research was gaining momentum across the world, it was “suppressed” in the US “due to the ideological stance adopted by” former US president George W Bush’s administration.

“The curious position adopted by the Bush presidency, enthusiastically enforced by the FDA, gave rise to widespread criticism internationally,” he said.

In South Africa, Van Rooyen argued in his affidavit, stem cell therapy had never been a crime.

“Our victimisation by the FDA forms part of its agenda to suppress new medical procedures, nutritional supplements, doctors and business that threaten the profits of big pharmaceutical companies,” he said.

The US wanted them extradited from South Africa, where in June 2006 they were arrested and detained for 10 days.

According to the US indictment, they had “recruited customers with the representation that science had proven the therapeutic power of stem cells and that Biomark was simply making it available to the world”.

In his 2017 affidavit linked to South African court proceedings, Van Rooyen alleged the 2006 US indictment against them was based on an affidavit by an FDA agent that contained misrepresentations and concealed the truth.

Long legal battle

In November 2012, the year after Brown died, the Kempton Park Magistrate’s Court found that the US could extradite Van Rooyen.

From 2013 to 2015 he fought the finding, but the Constitutional Court refused his application to appeal. Van Rooyen then petitioned the justice minister.

In September 2016 he was told his petition was unsuccessful. Despite financial problems, Van Rooyen pressed on.

“The indictment issued by the United States against me in 2006 and my conviction by the media … has caused me the utmost prejudice in trying to even earn a living in this country.

“My reputation as a credible and honest businessman has been irreparably damaged,” his 2017 affidavit said.

It continued: “Since 2006 I have effectively been unemployable. I have not been able to pursue any business opportunities in South Africa as my potential business partners have soon become reluctant to deal with me after they Google my name on the internet and read the negative and defamatory articles about me … I have lost everything and am living off the charity of a good friend.”

In the end, Van Rooyen managed to push ahead with legal processes that ultimately led to the 2019 decision that he will not be forced back to the US. DM168

This story first appeared in our weekly Daily Maverick 168 newspaper, which is available countrywide for R25.