Stem cell swindlers- support to the FDA

Stem cells:  promises, still to be confirmed

In a recent blog, I explained how the American authorities were brought to approve an ineffective drug, Sarepta, in Duchenne myopathy, under pressure from desperate patients well handled by swindlers. A similar story, but on a much greater scale, is emerging about stem cells, and there is muddy backwater where a lot of interested crocodiles jiggle.

 Stem cells are little differentiated cells able to transform in some (pluripotent stem cells) or all (totipotent stem cells) tissue types. This is the case of embryonic cells, but there are, in many adult tissues, stem cells - the oldest known are hematopoietic stem cells from bone marrow, able to differentiate into all blood cells. So bone marrow transplant to treat leukemia is the first cell therapy using stem cells, practiced since the 1970s. Similarly, skin stem cells are used since the 1980s to reconstitute the different layers of the epidermis for severely burned patients. In this sense, cell stem cell therapy is a well validated technique.

The use of embryonic cells, and furthermore the many discoveries of adult stem cells that have occurred, and even much more the discovery that it is possible to take many adult cells (for example, from epidermis) and turn them into stem cells by a  pretty simple and universal genetic manipulation  to give IPS  (induced pluripotent cells)  (a discovery for which Shinya Yamanaka  won the 2012 Nobel Prize for medicine)  have led to an explosion of hopes in this technique. Thus,  a flow of publications suggesting that it is possible to regenerate heart cells after a heart attack, regenerate neurons after strokes, cure macular degeneration by IPS cells differentiated into cornea cells have appeared. Hopes are also emerging in a number of neurodegenerative diseases.

Hopes, yes, but the path will be long. It is often not enough to inject cells so that they are implanted, it seems that they have first to be organized into micro-tissues. The results are sometimes difficult to reproduce. The use of stem cells is not devoid of potential dangers: rejection problems if they come from a donor, risk of tumor growth if they are induced, etc... The interpretation of the results is often difficult; Thus, in the case of the treatment of sequelae of strokes, the observed effect does not appear to be directly linked to stem cells (the injected cells disappear), but by the secretion of various substances.

So I think whe should call researchers to self-discipline and moderation, to caution and responsibility towards patients; even if it is difficult, we should call them to the understatement of their results rather than fancy proclamations; because they have to realize that there are many swindlers and crooks in the stem cells domain that will not hesitate to use their publications to defraud desperate patients.

The backwater and crocodiles of stem cells

Le Monde  (14, 11, 2016) has devoted an article to this topic (Stem cells, beware of fake treatments). Thus patients with ALS (SLA) illness resulting from the degeneration of motor neurons, which evolves to death within a few years, in the face of a medicine that remains powerless, are solicited by private clinics or doctors offering "miracle cures"  based on stem cells. "Patients are ready to go in any protocol or in any clinical trial, rather than stay in passivity, even overriding the rules of clinical research," says Jean-Paul Janssens (Geneva), who strives to alert them to the illegal nature of the treatment cell strains, which neither efficiency nor safety have been tested in humans". Jean-Paul Janssens remembers one of them who, some years ago, gave in to the offer of a clinic based in Tel Aviv, in Israel. The treatment cost him 35 000 Swiss francs (32 460 euros). His cells were taken in a clinic in French-speaking Switzerland before being sent to Israel to be isolated, treated and fed back, without success.

In the same Le Monde article, Leigh Turner, of the University of Minnesota noted: “Around 2008, we saw clinics appearing in countries where regulations are non-existent or little applied due to corruption, such as China, India, Mexico or the Caribbean. This statement is today no longer valid, those clinics now also grow in industrialized countries such as Australia, Japan, Switzerland, Florida or California. ». Thus the Swiss authority Swiss Medic became interested in the activities of two companies, Med Cell Europe and Swiss Medica (whose name is obviously looking to cause confusion with the Swiss regulatory agency itsel f!!). They claim to be able to cure more than 20 diseases, including ALS, Parkinson's, diabetes, heart attack... quoting on their sites dozens of publication in support of their claims. 

Swiss Medic put an end to their activities, but only in  Switzerland because Swiss Medica continues to recruit patients in Switzerland and send them in clinics to Russia and Serbia.

In Germany, Villa Medica claims the rather original and absolutely not validated use of fresh cells taken from sheep embryos. In Italy, for years, the Stamina Foundation treated patients suffering from neurodegenerative diseases by injections of stem cells –  “compassionate treatments”, without  any scientific basis; but Stamina was able to mobilize opinion and public authorities and even received public funds for his business. ”. The "inventor" of the Stamina method, Davide Vannoni, is today accused by Italian justice of fraud, conspiracy and usurpation of the title of doctor.

The swindlers at work and scientists responsabilities

An anecdote illustrates the methods of these swindlers: the Nobel Prize of medicine 2013 Jacky Shekman learned that the pro-Stamina lobby had cited him as one of their support because of an article criticizing the journal Nature; outraged, he answered in virulent terms: "my criticism of Nature have been distorted (...), they were not referring to the Stamina method. We (scientists), we call charlatans and snake oil salesmen who sell drugs whose effectiveness has not been attested ... From what I know, the Stamina method received no scientific validation, it has not been subject to clinical controls. Those who promote “miraculous” therapies without testing act criminally by exploiting vulnerable families who are desperately seeking treatment for their loved ones. »

The activity of these clinics exploiting the distress of patients has became so important that they organize lobbying defending their interests, involving the official agencies that track them. They rely on libertarian speeches and demagogic, explaining, for example, that FDA Regulation does more harm than good, that its rules lead to costs that impede innovation, they delay the arrival of innovations, that patients should be free to decide to hand themselves if they want to try these treatments, as if in despair they were free, lucid and competent to distinguish the scam of the scientific study.  Those people, those crooks are threatening FDA and other regulatory agencies, not the contrary ! And by manipulating desperate patients associations, their lobby has been successfull !; in Korea,  Japan, USA, bills are pushed forwards to break the regulatory framework of drugs put in place in all industrialized  countries for more than fifty years and allow commercialization of treatment based on stem cells on the basis of  very preliminary data !  They should not be allowed unless they have demonstrated their effectiveness and their safety according to recognized good practices !. Back to the Middle Age - Good profits for the swindlers, a return to the merchants of orvietans and theriaque!

It is the responsibility and honor of scientists to defeat the attempts of destabilization and circumvention of the regulatory agencies, to denounce the profiteers of the misfortune, and crooks who criminally exploit the hopes of stem cell, to ensure that their publications and statements are not diverted and exploited by charlatans, and, when they are aware of it,  to denounce them publicly as did Dr. Shekman, and, if necessary, supported by their institutions, to act through judicial. They should also be more careful in their publications. It is theirs to support the efforts of the agencies to prohibit these practices. Otherwise, the trust in the medical and therapeutic research will be even more challenged  and progress impossible, because people will be unable to  realize the difference between a clinical study conducted according to the rules of science and ethics and pure and simple charlatanism.