Stem Cell Clinic

The curious case of ClinicalTrials.gov, where dubious stem cell therapies seem legit – Ars Technica

Earlier this year, doctors reported the case of three women who went blind after having stem cells derived from their own fat injected directly into their eyeballsa procedure for which they each paid $5,000. Piecing together how those women came to pay for such a treatment, the doctors noted that at least one of the patients was lured by a trial listing on ClinicalTrials.gova site run by the US National Institutes of Health to register clinical trials. Though none of the women was ever enrolled in the trialwhich never took place and has since been withdrawnit was enough to make the treatment seem like part of legitimate, regulated clinical research.

At least 18 ostensible trials listed on the site offer similar stem cell treatments that participants must pay to receiveunlike most trials, which compensate rather than charge participants for experimental treatments. These trials, sponsored by seven companies total, claim to be developing therapies for a wide range of conditions, like erectile dysfunction, type II diabetes, vision problems, Parkinsons disease, premature ovarian failure, and chronic obstructive pulmonary disease (COPD). However, these trials are largely not backed by preliminary research. None of them has Food and Drug Administration approvaleven though the agency has published a draft guidance that suggests these treatments are subject to FDA regulation. And some of the studies are only granted ethical approval by review boards with apparent conflicts of interest and histories of reprimands from medical boards and the FDA.

Some of these studies, I mean, theyre just so outrageous, article author Leigh Turner, a bioethicist at the University of Minnesota, told Ars. But, to hook patients, a listing on ClinicalTrails.gov is helpful to stem cell clinics, he explains. A key thing that these businesses need to do is they need to look legitimate, they need to look credible, he explains. Listing studies on ClinicalTrials.gov is in some respects really clever from a marketing perspectiveand really dangerous.

Theyre taking a federally funded websitesupporting clinical research, he said, and using it as a marketing platform.

In his article Wednesday, Turner argued that the NIH should tighten restrictions on registering studies on the site. Right now, registration is largely based on the honor system. Its up to study sponsors to accurately note whether their study is subject to FDA regulation.

Some of these studies, I mean, theyre just sooutrageous

Many of the stem cell clinics argue that their work is not regulated by the FDA because theytreat each patient with the patient's own stem cells, called autologous-derived stem cells. In many cases, tissue is harvested from a patientoften fat tissue collected using liposuctionthen the tissue is processed in some way to obtain stem cells, which get injected back into the patient to treat any of several conditions. This was the case for the three blinded patients who received treatment at a clinic called US Stem Cell (previously known as Bioheart, Inc.).

Autologous treatments are exempt from FDA regulation if the cells are no more than minimally manipulated before they go back into the patient, the FDA noted to Ars. But a draft guidance that the agency has not yet enforced states that processing and isolating stem cells from tissue, specifically fat tissue, is not exempt. According to the draft guidance, this procedure involves cells that are more than minimally manipulated, because it alters the original relevant characteristics of the human tissue.

In a comment to Ars, the FDA said that, once the guidance is finalized, it will be able to apply the proper oversight to these stem cell treatments. In the meantime, it said:

We recognize that there are a number of clinics operating, which do not register with FDA. Consumers are encouraged to contact FDA and the appropriate state authorities in their jurisdictions to report any potentially illegal or harmful activity related to stem cell based products. We also encourage patients and health care providers to report adverse events associated with cellular therapies to FDA.

For now, stem cell clinics are skirting FDA oversight. Without enforcement, the only barrier to registering on ClinicalTrails.gov is to have an IRBinstitutional review boardsign off. These boards provide ethical oversight of a clinical trial and must be registered with the FDA.

See more here:
The curious case of ClinicalTrials.gov, where dubious stem cell therapies seem legit - Ars Technica

Doctors Used This Teen’s Own Cells to Cure Her Leukemiabut They Almost Killed Her First – Reader’s Digest

Courtesy Don CollinsEmma Collins was 14 when her parents began to notice something wasnt right with the typically energetic teen. Her father, Don Collins, tells Readers Digest: Emma was feeling tired and had very low energy at school. After a few days of noticing this, we had her blood tested. Collins continues, Later that night, the hematology lab called our house directly and told us to go to the hospital immediately. We took her in, and they confirmed our worst fear: Emma had leukemia. Emma was diagnosed with pre B acute lymphocytic leukemia (ALL), a fast growing form of leukemia that begins in the B cells of bone marrow. Approximately 80 to 85 percent of children diagnosed with ALL have a version that originates in B cells.

Shocked and heartbroken, Emma and her parents faced treatment options that included grueling rounds of chemotherapy. Collins recalls, Emmas treatment was three intensive rounds of chemotherapy, along with another medication called Sprycell. She was hospitalized at the Hospital for Sick Children in Toronto, Ontario for over six months. For the Collins, watching their daughter struggle to remain strong through the treatments was the most difficult.The lowest point for my wife and I was, seeing the gradual worsening of her health. She lost her hair, became unable to walk, and had constant infections that led to four ICU stays. She had very close calls with death, Collins explains. The Collins never gave up the belief that the next treatment would be successful, though their hopes were repeatedly dashed. Collins says, Of course, we kept hoping that the next round of chemotherapy would work, and when they all failed we were crushed. We were told that her chances of surviving another round of chemotherapy were extremely low, and it would likely yield the same negative results, he says. Patients with any cancer diagnosis should know these seven hopeful cancer statistics.

Left with no other viable chemotherapy treatment options, the Collins considered clinical trials. One of these trials was the CAR-T cell therapy, a new type of stem cell therapy with proven success in achieving remission for patients with leukemia. Doctors collect and then modify a patients own immune cells so that they recognize the cancer cells as an invader and mount a fight. Next, the modified cells are injected back into the patient to attack the cancerous cells. One serious drawback is that the treatment can also cause a potentially fatal immune reaction called cytokine release syndrome. While the reaction can be managed with medication, the patient can still feel lousy during treatment.

Courtesy Don CollinsDesperate to save their daughter, Collins and his wife agreed to try the CAR-T therapy. He says, With the news that all other treatment had failed, we kept up hope that this new treatment would help. Emma began to show signs of cytokine release syndrome only hours after the initial treatment; her fever spiked to 111 degrees, and she was nauseated. Her extremely elevated fever caused her to slip into a coma-like state, and she became unconscious for a short time, until doctors could stabilize her temperature.

Content continues below ad

A few days later, the Collins family received the stunning news: On the fourth day after treatment, the doctor came into our room and told us Emma was in full remission, Collins says. At first, it took a minute to sink inI was stunned but overcome with joy. We all sat together and laughed, cried, and went through all of the emotions that come with this kind of fantastic news. New medical developments are occurring at a fast pace with advancements in technology, and recent studies have also shown that good cholesterol, or HDL, can lower the risk of cancer.

Max Gomez, PhD, CBS News Medical Correspondent, and co-author of the upcoming book, Cells Are The New Cure, believes that cell therapy will be utilized in the future to treat many chronic conditions, like Alzheimers disease and type 1 diabetes. Cancer is only the beginning, Dr. Gomez told Readers Digest. We as humans have the hubris to think we can create drugs to heal peopleand we havebut weve got nothing on the human cell. According to Dr. Gomez, not only do the modified cells used in CAR-T therapy kill cancer cells during initial treatment, but they also create memory cells that continue to fight any cancerous cells that reappear once treatment has completed. This will completely change leukemia treatment for children and adultsand it already has, he says.

As for Emma, now 16, shes living the life her parents hoped she would. Shes doing great in remission, and has caught up in school, even achieving honor roll. She just received her drivers license, and she works out often to regain her balance and strength, something she lost from chemo, Collins says. He adds, Shes getting back to a normal teenagers life. Our greatest hope for Emma is to enjoy life and be happy and strong. We want her to look back on this and tell her grandchildren of the many great things she has achieved, including never losing hope and living through cancer. For patients that have reached remission there are several beneficial ways to care for yourself, mentally and physically after the cancer is gone.

Courtesy Don CollinsEmmas parents want other families facing a similar battle to know that though its new, trying CAR-T therapy can be worth the risk. He says, We absolutely encourage patients to proceed with this treatment. We know it can be scary as it is new, but we went from no hope to remission in four daysthat should give everyone hope. Hope means everything to a family going through a cancer diagnosis.

Go here to see the original:
Doctors Used This Teen's Own Cells to Cure Her Leukemiabut They Almost Killed Her First - Reader's Digest

These People Are Making Money Off A Bogus Cancer Cure That Doctors Say Could Poison You – BuzzFeed News

Apricot seeds can cure cancer or so thousands of cancer patients believed in the 1970s, despite lots of evidence to the contrary. Now, in an era when natural remedies are no longer fringe and wellness is a multitrillion-dollar industry, this widely debunked theory has taken on a new life as a hydra-headed e-commerce ecosystem that regulators are virtually powerless to stop.

Posted on July 30, 2017, 21:48 GMT

John Richardson thought hed found a cure for cancer.

The San Francisco Bay Area doctor had been giving patients a therapy that is essentially a chemical compound found in apricot kernels and known by several names laetrile, amygdalin, vitamin B17. Richardson had been told it could attack tumors, naturally and precisely. It can also convert into potentially poisonous amounts of cyanide when eaten. But Richardson was a true believer.

Yes, the evidence that Vitamin B17 is natures control for cancer is quite overwhelming, he wrote in his book. So the next time you hear an official spokesman for orthodox medicine proclaim that there is none, you might tell him that such a statement is a self-evident absurdity and suggest that he do his homework before posing as an expert.

Less convinced were the police who, on June 2, 1972, barged into Richardsons clinic and jailed him on charges of medical quackery. He eventually lost his medical license and was charged with smuggling laetrile, an illegal drug, into the country.

Now, three decades after Richardsons death, his son, John Richardson Jr., is no stranger to apricot seeds. Through Apricot Power, his thriving e-commerce store, he sells bitter seeds ($32.99 for 1,500), seed extract-based tablets (up to $97.99 a bottle), and B17-infused anti-aging cream ($49.99). Recipes for apricot-seed pesto, egg nog, and marzipan offer a delicious and easy way to work the supposed superfood into your diet, and videos explain why the sites mission is to get B17 into every body! Though Richardson Jr. wont reveal revenue numbers, he says his family operation of around 10 employees has served thousands of customers all over the world since it launched in 1999.

But theres a key difference between his business and his fathers, Richardson Jr. told me: We dont mention the C-word in our company. Cancer, that is. If a customer review on Apricot Powers website even mentions the term, the company leaves a comment pointing out that it doesnt make any disease or illness-related claims about its products. Legally, it cant: The FDA prohibits companies from selling laetrile, under any name, as a cancer treatment, because studies have found it to be at best ineffective, and at worst toxic.

Of course, that doesnt stop dozens of internet entrepreneurs from exploiting regulatory loopholes to sell apricot seeds and B17 tablets, no claims attached and profiting off the efforts of believers who spread the truth about them far and wide. In laetriles heyday in 1981, a doctor called it the slickest, most sophisticated, and certainly the most remunerative cancer quack promotion in medical history. Three decades later, the internet has only spread the gospel, creating an unstoppable, hydra-headed ecosystem of buyers and sellers.

A variety of apricot seed products available online.

If youve never heard that apricot kernels kill and prevent cancer, thats because the government doesnt want you to, proponents say. Cancer, according to them, arises from the lack of a nutrient they call vitamin B17, so it follows that ingesting that nutrient would fight the disease. But regulators, pharmaceutical companies, and doctors cant patent and profit from a natural substance. So they keep it off the market and peddle toxic, invasive, costly, and unnatural chemotherapy and drugs at patients expense.

The internet has created an unstoppable, hydra-headed ecosystem of B17 buyers and sellers.

Or so the theory goes. Vitamin B17 Is Banned Because It Treats Cancer! a post on the site Healthy Food House proclaims; it has been liked, commented on, and shared on Facebook more than 47,000 times since September, according to the social mediatracking tool CrowdTangle. A post about the real story of laetrile, published on a site called The Truth About Cancer, has gotten more than 44,000 likes, comments, and shares since June 2015.

Yin Ling Woo, a gynecological oncologist, recently had to decline when three cancer patients asked her to inject them with liquid B17 vials. They buy it off the internet, it arrives, they have to get someone to administer it, said Woo, who works in Kuala Lumpur, Malaysia.

Over the last year and a half, public health agencies in the European Union, Canada, and Dubai have issued warnings about apricot kernels and kernel-derived supplements. Since Australia and New Zealand outright blocked the sale of raw kernels in late 2015, retailers have been fined for continuing to sell them. In April, the FDA fired off warning letters to the sellers of more than 65 illegal cancer treatments, including whole apricots and vitamin B17. All the regulators cite the internet as the main source of the problem. Due to the nature of online marketing, some companies attempting to avoid compliance with FDA law simply start new websites and rename fraudulent products, an FDA spokesperson told BuzzFeed News in an email.

In other words, the FDA lacks the power to systematically fix the underlying issue. It can go after apricot kernels advertised as a cancer cure. But it cant crack down when theyre advertised as supplements or plain old seeds. Nor can it control the Facebook posts, YouTube videos, blogs, and tweets that perpetuate the myth.

And when the FDA calls out problematic claims, all a company has to do to escape scrutiny is stop using the phrases in question. But the misimpression that their product is an effective cancer cure will remain out there, uncorrected, in the public eye, said Patti Zettler, an associate professor at Georgia State Universitys law school and a former associate chief counsel at the FDA.

Its no coincidence that B17 is enjoying a second life online, at this moment in time. The internet is rife with misinformation about science and health, and the nutritional supplements business as part of the larger wellness industry is worth billions. Meanwhile, cancer remains a little understood disease that causes nearly 1 in 6 deaths worldwide. So in a way, its comforting and intuitive to blame a fixable vitamin deficiency. Its also wrong.

Felicity Corbin-Wheeler of Jersey, an island south of England, credits B17 injections and a strict diet with shrinking her pancreatic cancer in 2003. She refused chemotherapy, which aligns with her belief that the Western diet has been so hijacked by processed foods, sugars, fats, and salts.

Im all for the natural things, she said, that we get back to a simple life.

Ernst T. Krebs Jr., seen in San Francisco in 1980, was an early promoter of laetrile as a cancer treatment.

A successful salesperson must buy into what theyre selling, and Richardson Jr. is all in. Growing up in the Bay Area suburb of Orinda, he and his seven siblings werent fed sugar or processed wheat, an abstention he keeps up to this day. He says he started eating apricot seeds for his health at age 5. Now 52, hes up to 40 a day.

The seeds contain amygdalin, a compound also found in apple seeds and almonds. In the 1950s, Ernst T. Krebs Jr., a self-described doctor and biochemist with no medical degree, patented a purified form of amygdalin that he called laetrile. He also promoted it as vitamin B17, although its not an officially recognized vitamin.

In 1971, Krebs Jr. shared with the elder Richardson his theory of how this nutrient could stop cancer growth. As Richardson later summarized: [N]atures mechanism will not work if one fails to eat the foods that contain this necessary vitamin, which is exactly what has happened to modern man, whose food supply has become further and further removed from the natural state.

In Richardsons day, laetrilists were just as controversial as the anti-vaccine movement is today. In the 1960s, the FDA banned laetrile and reported that there was no evidence it treated cancer. But over the next decade, more than 70,000 Americans took it anyway. Many of them crossed into Mexico for injections denied by their stateside doctors. Actor Steve McQueen secretly traveled to Baja in 1980 to receive laetrile, among other alternative remedies, for an advanced lung cancer. He died months later. In the mid-70s, a scientist at Memorial Sloan Kettering Cancer Center performed experiments that he said showed laetrile helped reduce tumors in mice. A media relations staffer then leaked the data, claiming that hospital executives had sought to cover up and discredit it. Hes been making that claim ever since, including in the 2014 documentary Second Opinion (for the conspiracy-minded only, the Los Angeles Times wrote), and now charges cancer patients $500 for hourlong phone consultations.

In the mid-'70s, laetrilists were just as controversial as the anti-vaccine movement is today.

When the elder Richardson was arrested in 1972 (on charges that were dropped), it prompted his fellow members of the John Birch Society, the far-right conspiracist group of the era, to start a lobbying group to legalize laetrile. Later, Richardson was fined $20,000 and placed on probation on charges of conspiracy to smuggle laetrile from Mexico to the US. Indictments against him and 18 other accused promoters noted that he had deposited $2.5 million in his bank account over two years.

Even so, Richardson Jr. remembers his father, who died in 1988, as very principled, very honest, and very moral, and keeps a picture of him over his desk. Theres still people that contact me and tell me what a wonderful man he was and what a wonderful doctor he was, he said.

After long legal battles, the FDAs laetrile ban ultimately took effect in 1987. In 1999, Richardson Jr. started Apricot Power as an online-only store, but its branched out to health food shops over the last five years to meet customer demand. The company sources apricots from its farm and others in California, removes the flesh, air-dries the pits at the center, cracks them open, and sells the seeds inside.

A lot of the foods, the amygdalins been cooked out of it, said Richardson Jr., who also operates a real estate firm and a restaurant. And my dad believed a normal, healthy person should have 100 milligrams a day of amygdalin. Thats been our company motto since the beginning, is just getting amygdalin back into every body.

It took me no more than a few seconds to find apricot seeds online. A Google search led me to Amazon, where a European vendor was selling a 1-pound bag for $19.99 with this caveat: We do not treat, or aim to cure any disease. Still, its customers leave reviews like Raw Apricot Kernels help to stop Cancer in its tracks and I expect no miracles, but I dont want to die from chemotherapy. The seeds turned out to be chewy and tongue-curlingly bitter, with a long and unpleasant aftertaste.

Amazons algorithm recommended that I also buy the book thats the bible of this movement: World Without Cancer: The Story of Vitamin B17. First published in 1974 and now in its 24th printing, its by G. Edward Griffin, who has no scientific training, denies HIV, and pushes Sept. 11 conspiracy theories.

I tried to interview more than 35 e-commerce shops that sell seeds or supplements labeled as laetrile, amygdalin, or B17. Many declined to talk or never got back to me. A man at Raw Foods and Vitamins turned me down, explaining, The FDA and the government agencies have gone wild, theres so much money in Big Pharma. As soon as theres a little publicity, theyll be all over you. He did, however, text me pro-laetrile books and websites to look up.

Others were more open. Danny Hesman, who runs B17 USA full-time out of Los Angeles, said he has 5,000 repeat customers. I do tell people its not a magic pill, he said. But like some other vendors, hes had a personal experience with cancer in his case, a friend who died from it. I got a front-row seat to the suffering he went through with modern medicine, he said. I know these oncologists, I spoke to their team, they did everything. Its almost career suicide for professionals to even consider alternative therapies, which leaves [B17] in that fringe zone you see when you google vitamin B17. I wish there were some more professionals that would really work on that.

Many vendors, especially those in the US, repeatedly emphasized that they werent claiming to cure, treat, or prevent anything, as if the FDA were listening over the phone. But Our Fathers Farm in Ontario, Canada, sells kernels that may help with cancer prevention and symptoms. Vision B Seventeen in Kuala Lumpur, Malaysia, claims to have been successfully treating cancer and other degenerative diseases for more than 12 years now.

Regulators have tried to squash these kinds of vendors. Jason Vale, a professional arm wrestler in New York City, sold seeds as a cure on his website, Apricots From God, because he believed theyd healed his kidney cancer. He also spammed people with millions of email ads. But in 2003, Vale was sentenced to five years in prison for criminal contempt of a court injunction sought by the FDA to stop him selling.

Laetrile (i.e. Vitamin B17) therapy is one of the most popular and best known alternative cancer treatments.

B17 merchants may have been deterred by his conviction, but not defeated. Until recently, Oxygen Health Systems allegedly told customers, Laetrile (i.e. Vitamin B17) therapy is one of the most popular and best known alternative cancer treatments. This spring, the FDA slammed Oxygen with a warning letter for making that and other unsupported health claims. According to the agency, which sent similar warnings to 13 other businesses, Oxygen had also illegally described vitamin C, the fruit graviola, and flax seed oil as cancer therapies.

Owner Michael Carroll said by phone that many of his products personally helped him fight off non-Hodgkins lymphoma. He scrubbed the language targeted by the FDA. But he didnt seem too worried that his business would take a hit, or that his promises could have harmed someone.

Were continuing to work to make the best corrections to make our website as blah as possible, so consumers remain uneducated, said Carroll, who lives near Chicago. When we spoke in early May, Oxygen was still selling B17 bottles for up to $97; theyve since been taken down.

But you can still get them from Amygdalin Supply. Call to place an order and you might chat, as I did, with customer service rep Carlos Olguin in Guadalajara, Mexico. I asked him if, in his opinion, what he was selling could really treat cancer. His customers, he replied, were all the proof he needed.

If you go to a store and buy a product and the product doesnt work for you, would you buy again? he asked. Of course not, because the product does not work. Thats the thing I see. The same people who buy are the same people who are going to buy next and next and next.

Sandi Rog, a novelist outside Denver, Colorado, says that B17 saved her and can save others, too. She spreads the message on her blog, I Beat Cancer with Vitamin B17, and in three YouTube videos with a total of more than 956,000 views.

When Rog was diagnosed with non-Hodgkins T-cell lymphoma in late 2010, doctors put her through chemotherapy, radiation, and a stem cell transplant in an attempt to reinvigorate her immune system, she said. But tumors kept popping up. After a naturopathic doctor gave her dozens of supplements, she eventually narrowed them down to a regimen of juicing, pancreatic enzymes, and B17, which she began reading about and ordering online. She also stopped taking her prescribed immunosuppressant drugs. By the end of 2012, she said, the tumors were gone and she was in remission.

It makes me so angry, because people are being ripped off. "

All I know is Im cancer-free, she said, and its because of this.

Catherine Fox found Rogs videos very impressive when she started researching B17 as a preventative measure against cancer. Her parents, five aunts, and three uncles have all died of various cancers, she says. Then, about three years ago, she felt a lump in her breast the moment shed been dreading. So she started taking kernels. Thats likely why, she thinks, the lump ended up being harmless.

It seemed to just go down and go away, said Fox, who lives in Kells, Ireland, and, just to be safe, still eats two seeds every morning.

But Liz Beggs says that these stories offer a sense of false hope that harms people like her late niece, Charlene Campbell.

Campbell had a daughter who, not long after she was born, developed a rare, aggressive brain cancer and died. More than five years later, Campbell developed cancer, too, in her breast. Having watched her daughter undergo chemotherapy and radiation, she was determined to avoid them herself. So she started juicing, eating an all-vegetarian diet, and ordering cannabis oil and apricot seeds online. She said, This is my journey, its my body, I have to do it on my own, recalled Beggs, who lives in Northern Ireland. Youre either with me or against me.

Beggs understood why Campbell distrusted conventional therapies, but at the same time, we were so fearful, she said. Campbells tumor kept growing until she finally agreed to have a mastectomy. Then new tumors sprouted in her liver and spine.

Campbell died in October 2015, soon after her 33rd birthday. By the end, she was up to 40 apricot kernels a day, her aunt said.

It makes me so angry because people are being ripped off, Beggs said. That fear that engulfs a person when theyre diagnosed with cancer, they want to hold on to something thats positive, not the medical route. They want to hold on to this sick holistic path of believing in kernel seeds and whatever else across the internet.

Promoters of this all-natural cure cant agree on one name for it amygdalin, laetrile, Laetrile with a capital L, B17? Nor do they agree on how much to take and how often. Nor is there a way to ensure that the many seeds, pills, powders, and liquids in which it can take form are chemically consistent. All these variables make it hard to study its supposedly wondrous effects.

A 2015 review looked at the available studies of laetrile and amygdalin in humans and found no reliable evidence that they could cure cancer. On the whole, it concluded, the chances of bad side effects made the risks unambiguously negative.

In 1982, the Mayo Clinic put 178 cancer patients on laetrile, enzymes, vitamins, and a restricted diet, a regimen based on several laetrile doctors recommendations. When it came to getting cured, seeing their symptoms improve or disease stabilize, or living longer, they didnt substantially improve. On average, they survived less than five months after starting treatment.

I do remember some of the patients wanting it to be continued, believing it was working even though their tumor had clearly grown, they had gotten weaker and clearly more sick, said Gregory Sarna, a study co-author who was a UCLA oncologist at the time. That did not dissuade some of them from their belief that it was working.

Several patients also showed signs of poisoning, like nausea and vomiting, and blood levels of cyanide known to be fatal.

It doesnt take much. More than three small kernels, or less than half a large one, can be unsafe for adults, according to a report for the European Food Safety Authority. Even one small kernel can be toxic for toddlers. From 2000 to 2004, there were reports of 260 children poisoned by kernels in Turkey, where they are a common snack. One 2-year-old girl was severely poisoned and died after she ate 10 seeds. Laetrile fans, however, tend to promote much higher doses: One blogger cites World Without Cancers recommendation of 3 to 5 seeds per waking hour to treat cancer, and 7 to 10 a day to prevent it.

None of these contradictions faze consumers, who say scientists and doctors design studies to fail. They question whether people have really gotten sick or died from apricot kernels and if they did, they probably took way too much. (I never had a bad experience, said Elif Ercanli, who grew up eating seeds in Istanbul, Turkey.) The most theyll admit to is a bad side effect here or there. Rog said she once took nine in a 12-hour span and my blood pressure crashed so low, I was in bed, I had tingling in my fingers and toes.

When I asked people to explain how amygdalin works, they paraphrased, or told me to look up, World Without Cancer. According to Griffin, when amygdalin dissolves in body fluids and produces hydrogen cyanide, the cyanide only goes after cancer cells because of a special enzyme they contain thats vulnerable to attack.

That explanation doesnt make sense to Sarna, who is now an oncologist at Cedars-Sinai Medical Center. He points out that cancer cells differ even within a single tumor which is usually why when a treatment destroys some cells, others remain untouched. To say [one enzyme] is a general characteristic of cancer would need a study of hundreds of thousands of fresh cancers, all different cancers, he said. Ive never seen that done.

Theres no doctor in the world who doesnt want to help their patient get better. I never quite understood why theres this conspiracy theory that doctors or pharmaceutical companies would have an interest in suppressing something that works."

Even if there were one magical mechanism that unlocked the cure to cancer, Wendy Chen, a breast oncologist at Dana-Farber Cancer Institute, takes offense at the notion that physicians would cover it up.

Theres no doctor in the world who doesnt want to help their patient get better, she said. I never quite understood why theres this common conspiracy theory that doctors or pharmaceutical companies would have an interest in hiding or suppressing something that works.

Nevertheless, Griffins theories still light up Facebook groups like Cancer! Is B17 the cure? Brandon Clark, who says apricot seeds and B17 tablets got rid of a skin cancer on his nose, moderates the 3,000-person group. When he started contributing, he read B17 books and talked to B17-prescribing doctors to make sure people had the best information possible. Clark, who lives near Tacoma, Washington, prefers to share that research on Facebook because its much more popular than Twitter and Myspace and anything else, he said. I felt like I could reach more people.

Hes not wrong.

Theyre preying on people who are vulnerable and ill, Beggs said of people like Clark. Its just so not right. It makes me angry. Theyre being brainwashed. Charlenes proof of that.

The bottom of Apricot Power's Ground SuperFood Mix.

Apricot kernel devotees are fond of a certain Bible verse, Genesis 1:29: Then God said, I give you every seed-bearing plant on the face of the whole earth and every tree that has fruit with seed in it. They will be yours for food. There is an intuitive appeal to this implicit idea, that a higher force designed a natural substance to fight off a devastating and inexplicable disease.

Cancer kills 1 in 4 men and 1 in 5 women in the US. And surgery, chemotherapy, and radiation can sound frightening on their own, since they involve cutting open the body and flooding it with drugs and X-rays. The side effects range from unpleasant to downright unbearable.

Theyre preying on people who are vulnerable and ill. Its just so not right. It makes me angry. Theyre being brainwashed."

So there has always been an appetite, to some degree, for alternative therapies. And because of the enormous power of placebos, people often do feel better after taking them. In 1979, when the Supreme Court ruled that terminally ill cancer patients did not have the right to access laetrile, it noted that entrepreneurs had long hawked cancer cures like liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and Fountain of Youth mixtures of spices, oil, and suet.

But in 2017, once-fringe natural remedies are no longer distinct from the mainstream obsession with wellness, now a $3.7 trillion industry spanning organic food, yoga, meditation apps, anti-aging lotions and dietary supplements. Lifestyle guru Gwyneth Paltrow and alt-right fearmonger Alex Jones peddle silver nanoparticles and obscure mushrooms. In addition to being taken by 150 million people in the US, supplements are barely regulated, can contain anything, arent proven to help health, and send at least 20,000 Americans to the emergency room annually.

The fact there is a resurgence of interest in selling and utilization of what is essentially an ineffective treatment is concerning, and it points to general problems with the supplement market, said Ameet Sarpatwari, an instructor at Harvard Medical School, of B17. The amount of money being spent out there in supplements is huge. You would think that it should be more well-regulated than it is.

The wellness industrial complex is built upon vague pronouncements and falsehoods about how nutrition and bodies work, like the (unsupported) myth that genetically modified food is unsafe to eat. But if you buy into that, then perhaps its not so crazy to also believe that, say, the Hunza, an indigenous group in northern Pakistan, are cancer-free thanks to their apricot-heavy diet. (According to anthropologists, there are no credible studies to support the claim, which is central to the B17 ideology.)

The fact there is a resurgence of interest in selling and utilization of what is essentially an ineffective treatment is concerning, and it points to general problems with the supplement market.

As the internet breathes new life into health myths, it complicates the relationship between patients and doctors. No longer are physicians the main or exclusive source of medical information when people can Google a remedy, buy it on Amazon, and tell their Facebook friends about it.

So when cancer patients get excited about laetrile, or any other alternative therapy, doctors must balance the evidence, or lack thereof, with the desperation of people often on the verge of death. People need control over something that they cannot control, and that is very, very frustrating, and I sense it with every person I treat, said Don Dizon, clinical co-director of gynecologic oncology at Massachusetts General Hospital Cancer Center and a spokesperson for the American Society of Clinical Oncology.

Natural, though, does not mean safe. Toxins, cyanide included, abound in the natural world. All that matters is what are the benefits and harms, what is known for certain and what is merely unknown, said Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University, by email.

One patient of Prasads wanted to try high doses of vitamin C, but resisted radiation therapy because it seemed unnatural. Of course, Prasad noted, both vitamin C and radiation are naturally occurring, and both high dose [vitamin C] and a radiation machine are a human manipulation of something natural, so I wasnt sure there is a difference.

Dizon isnt always confident that chemotherapy will work, particularly in people whose cancer has returned, so he encourages some of them to push back. Hes even seen some tumors shrink after patients have taken natural remedies and hes accepted that he cant explain why. Sometimes, doctors say, a person may not actually have cancer in the first place, due to an incorrect diagnosis or misinterpreted biopsy. Or tumors can shrink due to other therapies that a patient has forgotten about or hasnt revealed.

Regardless, a couple moving anecdotes arent license to recommend an unproven remedy. That would be wrong, because thats not data, Dizon said. Thats not the same thing as saying, Your mom has ovarian cancer. If shes taking treatment, she has a 30% chance of cure and an 80% chance of going quite some time, even maybe years, before her cancer comes back.

With alternative therapies, the success stories that people cling to tend to be more isolated than they think. Youre not hearing the other side of that the patients who took it and died within weeks or whose cancers really grew, he said.

Vitamin B17, by any name, will never disappear. Its story by now has taken on mythical proportions that cannot be censored.

New advances in cancer treatment may one day make apricot seeds obsolete. But until even if all these therapies become the new and highly successful standard of care, some segment of laetrile believers will continue to buy in.

At Apricot Power, Richardson Jr. is busy rolling out products such as chocolate bars with chopped-up apricot seeds. (What a tasty way to get natural B17 in your diet! the website proclaims.)

What would his father think of all this? Hed be happy, Richardson Jr. answered, because he predicted that someday people would discover that nutrition was the answer to healthy living. He added, Lots of people believe an ounce of prevention is worth a pound of cure.

Stephanie Lee is a senior technology reporter for BuzzFeed News and is based in San Francisco.

Contact Stephanie M. Lee at stephanie.lee@buzzfeed.com.

Got a confidential tip? Submit it here.

News moves fast. Keep up with the BuzzFeed News daily email!

Great!

You're almost there! Check your inbox and confirm your subscription now!

See the original post here:
These People Are Making Money Off A Bogus Cancer Cure That Doctors Say Could Poison You - BuzzFeed News

Cell-Based Therapies in MS Remain Experimental, Expert Group Argues in Review Article – Multiple Sclerosis News Today

Clinical trials are the way to explore whether cell-based therapies are viable options for treating multiple sclerosis, a group of experts concluded in a publication exploring the state of research in the field.

The article, Cell-based therapeutic strategies for multiple sclerosis, was the result of discussions held at the International Conference on Cell-Based Therapy for Multiple Sclerosis in 2015. The experts reviewed evidence on a range of cell therapies, including stem cell transplants and delivery or stimulation of various cell types.

Clinical trials, the panel argued, would be the optimal way to examine which types of cells should be used, how they should be delivered, and the types and disease stages the treatments are suitable for.

The article, published in the journal Brain, focused on four types of cell-based treatments: autologous stem cell transplants, mesenchymal and related stem cell transplants, use of drugs to manipulate stem cells in the body to boost their ability to repair, and transplants of oligodendrocyte progenitor cells to trigger new myelin production. Loss of the myelin that protects neurons is a hallmark of MS.

Such treatments hold promise to attain what current disease-modifying therapies in MS have not: halting the disease without lifelong treatment that has potential side effects, and regenerating damaged tissue.

The International Conference on Cell-Based Therapy for Multiple Sclerosis was sponsored by the National MS Society which brought attention to the review in a news release and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Although plenty of research continues, there are issues that need to be resolved in order to steer the research in a healthy direction.

For instance, studies of autologous stem cell transplants have used an array of protocols and approaches.This makes it difficult to compare study results. The expert group said stem cell research would be better performed by networks of scientists who have agreed on a standard protocol.

Researchers also need to determine how to measure whether a stem cell therapy is working and how to monitor patients for safety.

For each approach, it is also necessary to determine which patients are likely to benefit from the treatment evidence that is currently only available for autologous stem cell transplants.

In addition to reviewing the evidence surrounding cell-based treatments, the expert group focused on the availability of the treatment options outside controlled trials.

Media attention has resulted in some cases of misrepresentation and exaggeration of therapeutic claims for cell-based therapies for multiple sclerosis and other diseases, the team wrote.

This has caused patients to seek the treatments paying out-of-pocket at unregulated clinics.

Often such clinics are for obvious reasons based in jurisdictions with less stringent medical regulatory structures, and so there can often be little if any assurance of the expertise, quality of care (or even hygiene), or ethical standards of the provider centre, which is often unwilling or unable to seek more traditional financial support for their research, they wrote.

Such clinics should at least confirm that the procedure is carried out by staff with appropriate qualifications, training, and experience. The clinic, and the treating physician, should also offer a written treatment plan, which should mention how complications will be monitored and managed, the team argued.

By far the most well-researched cell-based treatment option in MS is autologous stem cell transplants. The treatment, based on isolating a patients own blood or bone marrow stem cells, is combined with chemotherapy to wipe out the patients currently defective immune system. Once the immune system is eradicated, doctors transplant a patients stem cells back into the body to reboot the system.

The new stem cells give rise to a new population of immune cells, which if the treatment works do not causethe autoimmune properties characteristic ofMS.

While evidence suggests the treatment may be highly efficient in certain patients, it is not clear how it compares with other treatments that are considered highly effective.

The use of chemotherapy to eradicate a patients immune system brings with it risk of death. The experts, led by Dr. Neil Scolding ofSouthmead Hospital Bristol in the United Kingdom, noted that while procedures have become safer in recent years, risk remains the main argument against the treatment.

Patients with MS typically live for decades after a diagnosis, so any therapy with significant risk of mortality will not readily be accepted, the team wrote.

To evaluate the risk-efficiency profile of the treatment, a multi-center Phase 3 trial is needed to compare stem cell transplants with approved highly effective drugs.

Evidence is clear about who might benefit from such a treatment, the team wrote. Patients with active relapsing-remitting MS who are relatively young, with a disease duration of less than five years, are good candidates for the procedure, particularly if they do not respond to other treatment, evidence indicates.

In contrast, it is unlikely that autologous stem cell transplants will benefit patients with a long disease history or those who have progressive MS without recent inflammatory activity, they argued.

In an effort to improve the gathering of evidence supporting the treatment, they suggested that physicians who perform transplants outside the scope of clinical trials should collect data on the treatments safety and effectiveness andsubmit itto registries.

In addition, transplants should be performed at centers with MS expertise that are experienced in the procedure, the experts recommended.

Researchers have increasingly focused on mesenchymal stem cells power to treat various conditions, including MS. These cells are found in several adult tissues, including fat,umbilical cord blood, and bone marrow.

In contrast with the autologous stem cell transplant procedure, the use of mesenchymal stem cells does not involve chemotherapy. The idea is rather that the cell therapy should trigger the bodys own regenerative processes to repair damaged tissue.

To start the procedure, doctors isolate cells from a patient, grow them in a lab in a process that gets rid of other cell types, and inject them back into the patient. The injection can either be intravenous or through a spinal tap to inject cells into the central nervous system.

So far, there have only been small clinical trials of the procedure in MS patients. And researchers have yet to optimize the source or dose of cells that should be used, or the best method to grow and re-inject the cells into patients.

Several larger Phase 2 trials are underway, however, the team noted. These trials may clarify whether the treatment is effective in treating MS, and reveal which patients are likely to benefit.

In the central nervous system, myelin is produced by glial cells called oligodendrocytes. Researchers believe it may be possible to regenerate myelin by transplanting stem cells destined to become oligodendrocytes.

But the expert panel noted that there is evidence suggesting that it is not a lack of such cells that prevents remyelination. Rather, the absence of necessary factors in the body or the presence of inhibitory factors might be at work, they suggested.

Since MS involves damage not only to myelin, but also to nerve cell axons the long cell projections that send signals outward from a neuron it is also relevant to find out whether damaged axons can be remyelinated, they argued.

Moreover, researchers are unsure of how to prove that remyelination actually occurs in MS patients exposed to the therapy.

The U.S. Food and Drug Administration recently approved such an approach to be tested in patients.

Although this approach differs from the others the panel reviewed because it does not involve the handling of cells, it deserves mention.

The panel noted that several drugs in development, including opicinumab, are aimed at promoting remyelination. In addition, drugs that are already approved for other conditions might have remyelinating properties, and might be repurposed to treat MS.

Although studies are ongoing, the panel noted that it is unclear if the drugs do promote remyelination.

Despite ongoing research and in some cases clinical use of cell-based therapies for MS, these treatments should be considered experimental, the expert group concluded.

They again underscored the importance of clinical trials in providing a controlled environment for patients wishing to have cell therapy, as well as a source of evidence for the feasibility of these approaches.

Read the original:
Cell-Based Therapies in MS Remain Experimental, Expert Group Argues in Review Article - Multiple Sclerosis News Today