Last November, a Nevada court convicted two men of fraud for selling ineffective stem-cell treatments to people chronically ill with, among other disorders, multiple sclerosis or cerebral palsy.

According to the US Food and Drug Administration (FDA), one of the men, Alfred Sapse, targeted extremely ill patients with a method that he claimed to be proprietary — implanting portions of placental tissue into the abdomen. Sapse, the agency says, knew that he needed FDA approval for such a procedure. He didn’t have it. He claimed to be a doctor but didn’t have a licence. The other defendant, the physician who performed the procedures at Sapse’s bidding — on some 34 people in Las Vegas — knew “that it would not benefit the patients”. The pair “conducted no meaningful follow-up with the patients who underwent the implant procedures”. They did “not use any of the money for laboratory research, animal studies or human clinical studies relating to the short- and long-term effects of the implant procedures”. (Sapse made US$1 million from the treatments; he spent $700,000 of that on gambling and personal expenditure.) At least two patients suffered infections, and it is not clear what damage others might have incurred. In November 2006, the FDA issued a warning letter, telling the pair to stop. But they continued.

The incident shows the cavalier attitude with which many fraudsters approach the promising yet immature field of stem cells. It also shows the importance of the FDA’s regulatory role. Yet, as described on page 166, that role has been questioned by a Texas stem-cell-therapy company. The firm, Celltex Therapeutics in Houston, has demonized the agency to its patients, some of whom seethe at what they see as government intrusion.

The situation with Celltex is different from the Sapse case — the Texas company believes in its treatments, its doctors are real and its stem-cell manufacturing was registered with the FDA, for example. But the quality of the stem cells that Celltex used was not ensured, and follow-up on patients seems not to have been rigorous.

Celltex frames its dispute with the FDA as a conflict between a brave company that wants to offer cutting-edge medicine to desperate patients and a tyrannical bureaucratic ogre that is holding it back. But some of the facts don’t fit that simple narrative.

Patient care is about more than intervention. It demands top-quality processing facilities, systematic administration of therapies and meticulous follow-up, so that informed decisions can be made for current and future patients. If Celltex wanted to be the standard-bearer for a new form of cell-based therapy, if it wanted to have a showdown with a federal agency by demonstrating that regulations stand in the way of scientific progress and patient health, it should have produced the best evidence of safety and efficacy that it could muster. That would have stimulated an interesting and constructive debate and created real pressure for change at the FDA.

Patients are ready to take risks and clinical researchers are ready to do studies.

Certainly, there is room for the FDA to improve the regulation of stem cells. The large clinical trials that the rules currently demand are so expensive that many researchers and biotechnology companies cannot afford to conduct them. To ease that problem, the agency could explore expanding its ‘compassionate use’ clause, which allows individual patients to pay for drugs that are being used in FDA-approved trials. Alternative funding mechanisms, perhaps involving national insurance programmes, could be used to help offset the costs to patients and to those who perform the trials.

To enact such a change, the FDA would probably need more money to ensure that companies are serious about developing medicines and not simply seeking a loophole to increase profit. Increased FDA funding could also enable the agency to waive or reduce fees paid by the (usually small) biotechnology companies that develop the treatments. Organizations including the Alliance for Regenerative Medicine in Washington DC have been working with the FDA to create a regulatory environment more conducive to the development of stem cells.

More broadly, there has been a boom in people going abroad to receive stem-cell treatments. The World Health Organization (WHO) has taken a stand by issuing guidelines on how to regulate cell transplants. National authorities could actively engage with the WHO to ensure that those guidelines are effective.

All involved want to speed up the introduction of stem cells into the clinic. Patients are ready to take risks and clinical researchers are ready to do studies. Funding bodies should step up with money to help.

The matter is urgent. After the FDA turned up the heat, Sapse went to Mexico for three years before his arrest in 2010. Celltex is moving there now. The longer it takes to develop a workable and affordable system in nations such as the United States, the more patients will travel for treatment to countries where there are even more unknowns.