DCA is a promising treatment for cancer which has yet to pass clinical trials. It’s use in Cancer was discovered in 2007 at the University of Alberta, in Canada. It is also unlikely to be explored further because it is not a patentable substance. Likewise in Brazil a compound: phosphoethanolamine shows initial promise and patients are clamouring to get hold of it. Brazilian regulators blocked access pending a proper set of clinical trials.
The key medical ethics involved lie in your own personal interpretation of the Hippocratic Oath: “This, above all else, do no harm”.
Are physicians harming patients by allowing them access to promising yet not fully tested compounds and treatments? In general, contemplation of this thorny question is capable of generating scenarios which would confound even the most seasoned theologian. However in the case of DCA and phosphoethanolamine, these are drugs for people suffering from Cancer, often desperate for help. Here I say that patients wishes trump any medical ethics quandaries.
What follows is an article translated from Portuguese which appeared in Folha de S. Paulo, March 23, 2016
Original article: http://temas.folha.uol.com.br/o-futuro-do-combate-ao-cancer/polemicas/cientistas-sao-ceticos-sobre-pilula-da-usp-mas-ha-defensores-do-seu-uso.shtml
Terms:
USP: University of São Paulo
“phospho”: phosphoethanolamine
ICESP: Cancer Institute of São Paulo State
“USP pill”: vernacular for phosphoethanolamine pills produced at the University of São Paulo
Anvisa: Brazilian Health Surveillance (Oversight/Watchdog) Agency
Scientists are skeptical about the ‘USP pill’, but there are advocates of its use
DÉBORA MACHADO ANDRADE
SPECIAL to Folha de S.Paulo, from Oxford
March 23, 2016
The existence of a miracle pill, able to cure all types of cancer, is viewed with much suspicion by the international scientific community. The reason is that there are about 200 types of cancer, each with different mechanisms (of development).
That is why there is so much skepticism about the “phospho” as it is known the “cancer pill” developed by researchers from USP in São Carlos, São Paulo state.
“If this drug is supposed to work on all cancers, as a scientist I would say: could you tell me how?”, says Steve Jackson, professor at the University of Cambridge, UK.
Prof. Jackson is the inventor of the anticancer drug olaparib (marketed in 15 countries under the name LynparzaTM, awaiting approval in Brazil).
“The sad truth is that [phosphoethanolamine] is unlikely to be a miracle ,” wrote the editors of the journal “Nature”.
Indeed: the first characterization tests and synthesis of the “cancer pill”, published on March 21st, show low degree of purity and little or no effect on tumor cells. The results were released by the Ministry of Science and Technology.
The drug also will undergo clinical studies conducted with the participation of ICESP (Cancer Institute of São Paulo State Octavio Frias de Oliveira). “I hope to have some answers in the next six months,” says Prof. Paulo Hoff, director of the institute.
The House of Representatives and the Senate (in Brazil) have approved a bill that allows all cancer patients to have access to the substance.
Canada has also experienced the phenomenon of a “cancer pill.” In the case of Canada, the “pill” is called sodium dichloroacetate (DCA) and it emerged from research at the University of Alberta.
DCA has been used for years to treat rare metabolic diseases. A Canadian research group found that it also had antitumor effects in a wide range of cancers.
The discovery was in 2007. Dr. Akbar Khan, oncologist from Toronto, told Folha that one of his patients with advanced stage cancer proposed DCA as an alternative. He reviewed the study of Alberta team and decided to give the drug to his patients.
After a long legal process, it was determined that doctors could prescribe DCA, as long as the patient had already exhausted conventional treatment options. “We have seen some improvement in two thirds of patients,” says Dr. Khan.
The use of a drug that has not gone through clinical trials in patients who have exhausted the possibilities of medicine is called compassionate use.
“Anvisa and the Ministry of Health should facilitate access to compassionate use of products that already have some type of clinical basis,” says Prof. Hoff, director of ICESP.
“Our legislation is overly bureaucratic.”
One cannot yet frame the “phospho” in compassionate use category because it has no proven clinical foundation, explains Prof. Hoff.
He also noted that in the US about 85% of all cancer patients make use of some alternative therapy on their own account. “This is a reality in the whole world. Doctors must keep an open mind and discuss this issue,” he says.
In Canada, according to Dr. Khan, many doctors besides him prescribe DCA. They prefer not to assume it publicly for fear of prosecution and judgment of colleagues.
“The Hippocratic Oath: ‘this above all else, do no harm’ has been replaced by ‘this above all else, do not be sued,'” says Martin Winer, a journalist of Toronto and activist for compassionate use.
He organized a petition calling for open access to DCA, which has thousands of signatures.
For patients, the possibility of success of an experimental drug, however small, means a chance.
The former truck driver João Vianei Lopes, from Biguaçu, at the countryside of Santa Catarina state, founder of the Association of Friends and Cancer Patients of Santa Catarina, sighs: “What we want is to have access to hope, the cancer patient lives of hope “.
Vianei, diagnosed six years ago with non-Hodgkin’s lymphoma, also organized a petition with thousands of signatures for the release of “phospho”. “Now we will fight for approval [of phosphoethanolamine] in the Senate … and we will succeed.”
The debate over compassionate use is not trivial. For Adrian Harris, a professor at Oxford University, compassionate use potentially incurs more harm than good.
“Even if you have already tried five different chemotherapies, you will still have a better chance with a drug that is on the market and has been proved to be effective than with one that has not been tested. I support that everyone has access to approved drugs.”
Prof. Jackson, of Cambridge, disagrees: “If you are a cancer patient and only have a few months of life, the situation is different. I could never tell these people if they should or should not try something.”.
Researchers polled by this reporter are unanimous in advocating greater support for clinical studies to accelerate cancer research.
“We try to put the patient in clinical trials as soon as possible,” says Prof. Harris, who is proud to say that in the UK around 10% of cancer patients are participating in a clinical trial.
In the US, the goal is about 5% of patients. Brazil, however, now has less than 1%, regrets Prof. Hoff.
As always you speak well and share the promising new* hope for all. How can anyone think it is ethical to say no to one who has no other options except to await deaths final calling.?