Below we see yet another broadcast doctor---Dr Suzuki writing an article posted by DAILYINFORMATOR-----note that Dr Suzuki went to UNIVERSITY OF CHICAGO---many of our fake TV medical doctors graduated from hyper-global banking neo-liberal institutions like University of Chicago. We can be sure Dr Suzuki is tied to GMO -----plants, animals, humans. The article below has the goal of making 99% of WE THE PEOPLE afraid of EVERYTHING around us----now genetic changes are happening from eating GMO foods----and that is ABSOLUTELY FALSE.
THE INFORMATION IN THIS ARTICLE IS NOT TRUE-----GLOBAL BANKING 1% TRYING TO CREATE ALL KINDS OF FAKE WAYS GMO ANIMALS AND GMO HUMANS WILL MUTATE.
GMO FOODS from MONSANTO have always had a goal of EVOLUTIONARY DISRUPTION creating ECONOMIC DISRUPTION bringing conditions for POPULATION collapse. GMO FOODS may indeed create cancers eaten over decades just as food grown with fertilizers and pesticides-----it does NOT cause human genetic (DNA mutation)
'Geneticist David Suzuki recently expressed his concern, saying that human beings are part of a “massive genetic experiment” over many years, as thousands of people continue to consume GMO’s, and it makes sense'.
'David Suzuki - Wikipedia
David Takayoshi Suzuki CC OBC FRSC (born March 24, 1936) is a Canadian academic, science broadcaster and environmental activist.Suzuki earned a Ph.D. in zoology from the University of Chicago in 1961, and was a professor in the genetics department at the University of British Columbia from 1963 until his retirement in 2001'.
Far-right wing global banking media and academics being allowed to MYTH-MAKE the causes of GMO HUMANS-----PLOS PUBLIC LIBRARY OF SCIENCE appears to be very much SILICON VALLEY, CA--------global banking 1%
CONFIRMED: DNA From Genetically Modified Crops Can Be Transferred Into Humans Who Eat Them
Published on March 7, 2018
In a new study published in the peer reviewed Public Library of Science (PLOS), researchers emphasize that there is sufficient evidence that meal-derived DNA fragments carry complete genes that can enter into the human circulation system through an unknown mechanism. (0) I wonder if the scientists at these biotech corporations have already identified this method?
In one of the blood samples the relative concentration of plant DNA is higher than the human DNA. The study was based on the analysis of over 1000 human samples from four independent studies. PLOS is an open access, well respected peer-reviewed scientific journal that covers primary research from disciplines within science and medicine. It’s great to see this study published in it, confirming what many have been suspecting for years.
When it comes to genetically modified crops and foods, we really have no idea of what the long term effects will be on the public. The very first commercial sale of genetically modified foods was only twenty years ago in the year 1994.
There is no possible way that our health authorities can test all possible combinations on a large enough population, over a long enough period of time to be able to say with certainty that they are harmless.
Geneticist David Suzuki recently expressed his concern, saying that human beings are part of a “massive genetic experiment” over many years, as thousands of people continue to consume GMO’s, and it makes sense.
Advances in genome science over the past few years have revealed that organisms can share their genes. Prior to this, it had been thought that genes were shared only between individual members of a species through reproduction.
Geneticists usually followed the inheritance of genes in what they would call a ‘vertical’ fashion, such as breeding a male and female -you follow their offspring and continue down the road from there. Today, scientists recognize that genes are shared not only among the individual members of a species, but also among members of different species.
“Our bloodstream is considered to be an environment well separated from the outside world and the digestive tract. According to the standard paradigm large macromolecules consumed with food cannot pass directly to the circulatory system.
During digestion proteins and DNA are thought to be degraded into small constituents, amino acids and nucleic acids, respectively, and then absorbed by a complex active process and distributed to various parts of the body through the circulation system.
Here, based on the analysis of over 1000 human samples from four independent studies, we report evidence that meal-derived DNA fragments which are large enough to carry complete genes can avoid degradation and through an unknown mechanism enter the human circulation system.
In one of the blood samples the relative concentration of plant DNA is higher than the human DNA. The plant DNA concentration shows a surprisingly precise log-normal distribution in the plasma samples while non-plasma (cord blood) control sample was found to be free of plant DNA.” (0)
It’s not like a human being mates with an apple, banana or a carrot plant and exchanges genes. What biotechnology and biotech corporations like Monsanto have done, is they have allowed for the transfer of genes from one to the other without any regard for the biological limitations, or constraints. The problem with this is that it is based on very bad science.
The conditions and biological ‘rules’ that apply to vertical gene transfer, at least those that we are aware of, do not necessarily apply to horizontal gene transfer. Biotech science today is based on the assumption that the principles governing the inheritance of genes are the same when we move genes horizontally as they are when they are moved vertically. It just goes to show that GMO’s should be subjected to much more experimentation and rigorous research before we continue to consume them.
How can our governing health authorities approve these as safe? It’s almost as if they told us they were safe, and we just believed them without questioning it. We seem to be a very gullible race, but things are changing and more are starting to question the world around them.
“One small mutation in a human being can determine so much, the point is when you move a gene, one gene, one tiny gene out of an organism into a different one you completely change its context. There is no way to predict how it’s going to behave and what the outcome will be. We think that we design these life forms, but it’s like taking the Toronto orchestra prepared to play a Beethoven symphony and then you take some random drummers from “here” and flip them in with the Toronto symphony and you say play music. What comes out is going to be something very very different. Publicists say that there is good intention behind GMOs, but the fact of the matter is it’s driven by money.” – David Suzuki
I personally believe the intentions go beyond money, but that’s another story.
It’s also pretty clear that DNA from food can and does end up in animal tissues and the milk products that people eat. (4)(5)
There are studies that show when humans or animals digest genetically modified foods, the artificially created genes transfer into and alter the character of the beneficial bacteria in the intestine. Researchers report that microbes found in the small bowel of people with ilestomy are capable of acquiring and harboring DNA sequences from GM plants.
(1) Genetically modified crops have infiltrated animal feed since 1996, and it’s normal for them to have a complete GM diet. Studies have linked GMO animal feed to severe stomach inflammation and enlarged uteri in pigs.
It’s also important to note that gene transfer among genetically engineered agricultural crops and surrounding native species has given rise to a highly resistant species called super weeds. According to the world health organization, gene transfer and the movement of genes from GM plants into conventional crops or related species may have an effect on food safety and food security.
“This risk is real, as was shown when traces of maize type which was only approved for feed use appeared in maize products from human consumption in the United States.” (3)
The truth is, genetic engineers have never taken the reality of gene transfer into consideration when they produce these things and introduce them into the environment. As a result, we are now starting to see the consequences of genes that are engineered, particularly how they spread and alter other organisms in various environments.
Watrud et al (2004) found that the herbicide-resistance transgene spread via pollen to an area up to 21 km beyond the control area perimeter and had pollinated wild creeping bentgrass.(2)
Prior to this year, governments concluded that transfer of DNA from GM crops/foods is unlikely to occur. Now we can see that they are wrong, or perhaps they had knowledge of this already? Regardless of the fact that DNA from GM foods can be transferred to humans and animals, very little is still known today and what is known does not look good. There are studies linking GMO’s and pesticides to various ailments.
We’ve presented and written about them on our website numerous times, this is another article to add to the growing amount of evidence to suggest we need to halt the production of GMO’s until we conclusively know that they are safe for human consumption.
It’s not a mystery why most countries around the world have completely banned GMO’s.
The dangers to human health from GMO FOODS tied to installation of pesticide or fertilizer into seed genetics has ALWAYS BEEN KNOWN. CLINTON era 1990s had Bill and Hillary as cheerleaders for MONSANTO-----Bush family was the oil producing family wanting new PRODUCTS for oil---ergo GREEN REVOLUTION fertilizers and pesticides---and GMO seeds. We need to think of GMO MONSANTO seeds as ingesting any plant exposed to chemicals like pesticides and fertilizers. They will cause cancers over decades of exposure-----they do not cause genetic mutations in humans. Genetic mutations in humans occur naturally and randomly usually tied with errors in our DNA replication. There are a few cases such as radiation exposure for example from long-term sun UV exposure or nuclear bomb weapon exposures that can cause short-term human genetic mutation.
What is happening to 99% of US and global citizens regarding GMO FOODS is an attack on public health creating disease vectors-------and the goal of controlling the world's food supply with intentions of creating massive crop collapse----starving masses of global citizen.
PLEASE DO NOT ALLOW SCARE TACTICS RUNNING WILD IN NATIONAL MEDIA AND FROM CORPORATE ACADEMICS TAKE OUR 99% PROTESTS FROM STOPPING MOVING FORWARD.
Remember our science-------if a human does have genetic mutation from natural DNA replication or exposures to high-energy radiations----it will not pass on to next generation because those mutations cause STERILITY.
What is a gene mutation and how do mutations occur?
A gene mutation is a permanent alteration in the DNA sequence that makes up a gene, such that the sequence differs from what is found in most people. Mutations range in size; they can affect anywhere from a single DNA building block (base pair) to a large segment of a chromosome that includes multiple genes.
Gene mutations can be classified in two major ways:
- Hereditary mutations are inherited from a parent and are present throughout a person’s life in virtually every cell in the body. These mutations are also called germline mutations because they are present in the parent’s egg or sperm cells, which are also called germ cells. When an egg and a sperm cell unite, the resulting fertilized egg cell receives DNA from both parents. If this DNA has a mutation, the child that grows from the fertilized egg will have the mutation in each of his or her cells.
- Acquired (or somatic) mutations occur at some time during a person’s life and are present only in certain cells, not in every cell in the body. These changes can be caused by environmental factors such as ultraviolet radiation from the sun, or can occur if an error is made as DNA copies itself during cell division. Acquired mutations in somatic cells (cells other than sperm and egg cells) cannot be passed to the next generation.
Somatic mutations that happen in a single cell early in embryonic development can lead to a situation called mosaicism. These genetic changes are not present in a parent’s egg or sperm cells, or in the fertilized egg, but happen a bit later when the embryo includes several cells. As all the cells divide during growth and development, cells that arise from the cell with the altered gene will have the mutation, while other cells will not. Depending on the mutation and how many cells are affected, mosaicism may or may not cause health problems.
Most disease-causing gene mutations are uncommon in the general population. However, other genetic changes occur more frequently. Genetic alterations that occur in more than 1 percent of the population are called polymorphisms. They are common enough to be considered a normal variation in the DNA. Polymorphisms are responsible for many of the normal differences between people such as eye color, hair color, and blood type. Although many polymorphisms have no negative effects on a person’s health, some of these variations may influence the risk of developing certain disorders.
'Experiments have shown that microplastics can lead to poor health outcomes in some species, and research is underway to find out how the plastics affect humans'.
Just to show media and what are being allowed to be called FOUNDATIONS FOR OVERSIGHT of public health----LYING so global banking 1% can CHEAT AND STEAL for profits at the same time DELIBERATELY destroying our natural resources and environment----goals of DEPOPULATION at work around the world ----but RUSSIAN SIBERIA---THAT IS GLOBAL 1% CLIMATE CHANGE ECO-DOME UTOPIA.
We showed an article from a FAKE public health foundation used by our US city and county councils and mayors to say MICROPLASTIC AS ASPHALT is not harmful----when in fact we have known for decades it is indeed VERY HARMFUL to both public health and environment.
Hard plastics like our TV or computer frames or construction plastics do resist degradation. When we break plastics down to microplastics----to products built with COMPOSITE PLASTICS like HOT YOGA CLOTHES----that is when plastics DO degrade. Plastics exposed to heat----as in laying PLASTIC ASPHALT change the form of that plastic from resisting degradation to being degraded. Add the heat from laying asphalt to streets enduring heat and sun of summers over years and we have a PUBLIC HEALTH CRISES with microplastics in our soil, water, and breathed through the air.
CLINTON/BUSH/OBAMA AND THEIR 5% POLS AND PLAYERS KNOW THIS AS THEY ROLL OUT THE MICROPLASTICS AS PRODUCTS.
Patagonia's New Study Finds Fleece Jackets Are a Serious Pollutant
The brand commissioned a study to find out how many synthetic microfibers—the tiny bits of plastic that marine scientists say could be jeopardizing our oceans—are shed from its jackets in the wash. The results aren't pretty.
It all started on a beach in southwestern England in the early 2000s. Richard Thompson, then a senior lecturer at Plymouth University (where he now serves as professor of marine biology), was leading a team of graduate students researching microplastics in marine environments. Examining samples of sandy sediment, they expected to find degraded bits of marine plastic from decades-old flotsam or plastic beads that were becoming widely used in cleaners. To their surprise, most of the plastic fragments were fibrous, which meant they likely came from clothing, rope, or some types of packaging.
Then, in 2011, Mark Browne, one of Thompson’s former graduate students, published a study in which he examined sediment sampled from 15 beaches around the world. He found high concentrations of polyester and acrylic fibers in samples taken near wastewater treatment plants. He then ran a polyester fleece jacket through the wash and filtered 1,900 fibers from the wastewater—fibers that otherwise would have gone to the local wastewater treatment plant. Browne started reaching out to apparel makers to see if they’d help fund research to study this issue more deeply—eventually, he hoped, finding tweaks to fabric design or apparel construction that would stop the microfibers from entering wastewater. He received one offer of help—from women’s clothing brand Eileen Fisher—but Patagonia, Columbia, and other big brands declined, saying they didn’t know if the fibers were anything they needed to worry about.
Fast-forward four more years, and the fibers finally got everyone’s attention. The science was piling on, showing that wastewater treatment plants couldn’t filter out all synthetic fibers, and that toxins such as DDT and PCBs can bind to them as they make their way into watersheds. It also showed that small aquatic species ingest the fibers, and that fish and bivalves sold for human consumption also contain microfibers. Experiments have shown that microplastics can lead to poor health outcomes in some species, and research is underway to find out how the plastics affect humans.
Jill Dumain, director of environmental strategy at Patagonia, was one of the people paying attention to all the news. In early 2015, she and the company’s leadership decided to commission a study to find out if and how Patagonia’s iconic and well-loved fleeces and some other synthetic products were contributing to the problem. The results recently came in, and they’re not good.
CLINTON/BUSH/OBAMA ended what was our strong FEDERAL CHEMISTRY OVERSIGHT AND EVALUATION studies used to set public safety standard for exposures--------what this article states is just that-----plastics industry says it did tests and found no harm and we have no public agency data to show it really does. This is what our US PUBLIC UNIVERSITY research did all last century-----Clinton/Bush/Obama corporatized our US PUBLIC UNIVERSITIES making them the source of BAD DATA and propaganda.
The GREENER SOLUTIONS would be to recycle hard plastic TV/computers back into being large-use products-----NOT microplastics. GREENER solutions are being done in some universities where research is being done to break all these plastics down to ORIGINAL CHEMICAL COMPONENTS-----taking those plastics out of circulation.
We have watched as plastic products we were told were safe were used as ASTROTURF-----and PLAYGROUND SURFACING we knew then and we know now those materials break down and become those MICROPLASTICS that DO HARM PUBLIC HEALTH.
Plastic Not-So-Fantastic: How the Versatile Material Harms the Environment and Human Health
The chemical building blocks that make plastics so versatile are the same components that might harm people and the environment. Greener solutions, however, are becoming available
Credit: CAROL MITCHELL/FLICKR
From cell phones and computers to bicycle helmets and hospital IV bags, plastic has molded society in many ways that make life both easier and safer. But the synthetic material also has left harmful imprints on the environment and perhaps human health, according to a new compilation of articles authored by scientists from around the world.
More than 60 scientists contributed to the new report, which aims to present the first comprehensive review of the impact of plastics on the environment and human health, and offer possible solutions.
“One of the most ubiquitous and long-lasting recent changes to the surface of our planet is the accumulation and fragmentation of plastics,” wrote David Barnes, a lead author and researcher for the British Antarctic Survey. The report was published this month in a theme issue of Philosophical Transactions of The Royal Society B, a scientific journal.
As the scrutiny of the environmental toll of plastic increases, so has its usage, the scientists reported.
Since its mass production began in the 1940s, plastic’s wide range of unique properties has propelled it to an essential status in society. Next year, more than 300 million tons will be produced worldwide. The amount of plastic manufactured in the first ten years of this century will approach the total produced in the entire last century, according to the report.
“Plastics are very long-lived products that could potentially have service over decades, and yet our main use of these lightweight, inexpensive materials are as single-use items that will go to the garbage dump within a year, where they’ll persist for centuries,” Richard Thompson, lead editor of the report, said in an interview.
Evidence is mounting that the chemical building blocks that make plastics so versatile are the same components that might harm people and the environment. And its production and disposal contribute to an array of environmental problems, too.
• Chemicals added to plastics are absorbed by human bodies. Some of these compounds have been found to alter hormones or have other potential human health effects.
• Plastic debris, laced with chemicals and often ingested by marine animals, can injure or poison wildlife.
• Floating plastic waste, which can survive for thousands of years in water, serves as mini transportation devices for invasive species, disrupting habitats.
• Plastic buried deep in landfills can leach harmful chemicals that spread into groundwater.
• Around 4 percent of world oil production is used as a feedstock to make plastics, and a similar amount is consumed as energy in the process.
People are exposed to chemicals from plastic multiple times per day through the air, dust, water, food and use of consumer products.
For example, phthalates are used as plasticizers in the manufacture of vinyl flooring and wall coverings, food packaging and medical devices. Eight out of every ten babies, and nearly all adults, have measurable levels of phthalates in their bodies.
In addition, bisphenol A (BPA), found in polycarbonate bottles and the linings of food and beverage cans, can leach into food and drinks. The U.S. Centers for Disease Control and Prevention reported that 93 percent of people had detectable levels of BPA in their urine.
The report noted that the high exposure of premature infants in neonatal intensive care units to both BPA and phthalates is of “great concern.”
Polybrominated diphenyl ethers or PBDEs, which are flame-retardants added to polyurethane foam furniture cushions, mattresses, carpet pads and automobile seats, also are widespread.
The plastics industry maintains that its products are safe after decades of testing.
“Every additive that we use is very carefully evaluated, not just by the industry, but also independently by government agencies to look at all the materials we use in plastics,” said Mike Neal, a consumer and environmental affairs specialist at PlasticsEurope, an industry trade association, and a co-author of the report.
But some of these chemicals have been shown to affect reproduction and development in animal studies, according to the report. Some studies also have linked these chemicals with adverse effects in people, including reproductive abnormalities.
“We have animal literature, which shows direct links between exposure and adverse health outcomes, the limited human studies, and the fact that 90 to 100 percent of the population has measurable levels of these compounds in their bodies,” said John Meeker, an assistant professor of environmental health sciences at the University of Michigan School of Public Health and a lead author. “You take the whole picture and it does raise concerns, but more research is needed.”
Shanna Swan, director of the University of Rochester's Center for Reproductive Epidemiology, conducted studies that found an association between pregnant women’s exposure to phthalates and altered genital development in their baby boys.
Also, people with the highest exposure to BPA have an increased rate of heart disease and diabetes, according to one recent study. Animal tests studies of PBDEs have revealed the potential for damaging the developing brain and the reproductive system.
Yet the effects on human health remain largely unknown. To help shed more light on the issue, the report recommends more sophisticated human studies.
“It’s tough to have a smoking gun with a single animal study or observational human study,” Meeker said. “We need to have different types of studies indicating a consistent pattern to more definitively determine health effects resulting from these chemicals.”
But testing humans for endocrine disruptors can be tricky because phthalates and BPA pass through the body so quickly. In addition, tests for each chemical cost about $100 a pop.
Deciding which chemicals to test and at what dose is also an issue. To date, most studies have addressed single chemicals, and there are limited data on the interactions between chemicals. Compounding the problem is the discovery that endocrine disrupting chemicals may have effects at doses lower than those used in the Environmental Protection Agency’s standard toxicity tests.
Swan said the old model of testing should be thrown out and that the new goal should be tests that mimic real human exposure.
“It’s a very complicated picture and the laboratory model of just taking one isolated chemical and giving it to a genetically pure strain of rats in clean cages, clean air and clean water and seeing what it does just doesn’t come close to mimicking the human situation,” she said.
Many researchers recommend studies that test pregnant women as well as their children. The National Children’s Study will do just that by examining environmental influences on more than 100,000 children across the United States, following them from before birth until age 21.
“There are so many questions now with these chemicals in relation to cardiovascular disease, age and puberty, obesity, developmental disorders,” said Swan. “We don’t know what’s causing it, only hints, so the beauty of the National Children’s Study is that we can look at all of these endpoints and it should reveal a lot of answers.”
Plastic’s problems extend beyond the human body, according to the report. More than one-third of all plastic is disposable packaging like bottles and bags, many of which end up littering the environment.
Although the image of a bird tangled in a plastic necklace is by now burned into the public’s eye, ingestion of plastic fragments is much more common. Once inside, plastic can pack a one-two punch by both clogging an animal’s stomach and poisoning it with chemicals that have concentrated in the plastic. Some chemicals are then transferred to the food web when animals eat them.
More than 180 species of animals have been documented to ingest plastic debris, including birds, fish, turtles and marine mammals, according to the report.
Unfortunately, collecting data on plasticizers’ impacts on wildlife suffers the same pitfalls as studying human health. Still, there is already evidence that chemicals associated plastics might harm wildlife.
For example, laboratory studies have shown that phthalates and BPA affect reproduction in all studied animal groups and impair development in crustaceans and amphibians.
“While there is clear evidence that these chemicals have adverse effects at environmentally relevant concentrations in laboratory studies, there is a need for further research to establish population-level effects in the natural environment,” according to the report.
THESE ARE THE PUBLIC AGENCIES THAT SHOULD BE SHOUTING LOUDLY BEFORE THESE PRODUCTS ARE INSTALLED-------we know Baltimore is using plastic road paints we know Baltimore will use plastic asphalt because we have no PUBLIC HEALTH in Baltimore....We showed PORTLAND OREGON as using plastic asphalt.
Not a word from these MARYLAND AGENCIES calling themselves ENVIRONMENTAL to STOP MOVING FORWARD SMART CITIES and US cities as Foreign Economic Zones filled with massive global corporate campuses, global factories, exporting all our US natural resources through our US PORTS.
CORPORATE SUSTAINABILITY IS THE OPPOSITE OF 99% WE THE PEOPLE AND OUR ENVIRONMENT SUSTAINABILITY.
Marine Debris Program Participates in Baltimore Underground Science Space Microplastics Panel
Tiny pieces of plastic laying in sand.
Microplastics in a beach environment. Image credit: NOAA.
OCTOBER 6, 2017--On September 22, 2017, staff from the Marine Debris Program’s (MDP) Research Coordinator, Carlie Herring, gave a microplastics presentation and participated in a panel discussion –
A Plastic World: Are microplastic choking our environment? (link is external) – held at the Baltimore Underground Science Space (link is external)(BUGSS).
Other presenters and panelists included Julie Lawson, Executive Director of MDP partner Trash Free Maryland (link is external), Jason Rolfe (MDP Mid-Atlantic Regional Coordinator), and Alterra Sanchez, a graduate student at the University of Maryland, College Park. Approximately 25 community members attended the event and asked questions about the sources and fate of microplastics, effects on wildlife, and potential solutions including the use of biodegradable plastics.
BUGSS is a non-profit public laboratory offering classes, seminars, and laboratory access so that anyone can safely and affordably investigate science and the living world. This community-based science lab was established five years ago. They currently have a high school class exploring the issue of biodegradable plastics.
For additional information, please contact Carlie.Herring@noaa.gov (link sends e-mail) or Jason.Rolfe@noaa.gov (link sends e-mail)
'The options being discussed include a down-payment model, with annual payments. University of Washington economist Anirban Basu has proposed an alternate health currency, HealthCoin, that insurers pay for when buying a cure and then sell to another insurance plan at a depreciated price if a patient switches insurers or becomes eligible for Medicare'.
The US has these few decades seen such incredible profiteering and fraud in health care and medicine----we have seen such incredible GATEWAY MEDICINE policies allowed to exist creating conditions to make US citizens SICK so as to treat them. We are seeing today global PHARMA being allowed to push soaring numbers of PHARMA PRODUCTS to market that harm-----or do nothing to help the health of 99% WE THE PEOPLE. In the process-----trillions of dollars from Federal health and human services---from our health savings accounts like Medicare----public health for poor MEDICAID all filled with fraud---giving NO patient outcome that was positive. This is why the US is ranked third world in health outcomes.
Above we see our BALTIMORE-BASED economist used by global Wall Street Baltimore Development to sell BAD ECONOMIC POLICY has moved to Seattle and University of Washington----selling more BAD ECONOMIC POLICY. At best------if gene manipulation for disease vectors end REALLY working-----99% of WE THE PEOPLE will not access them----despite BASU pretending policies are being moved for MEDICARE.
Finding the gene tied to blindness and correcting that genetic error----is far different than finding ONE, TWO, or dozens of genes tied to complicated disease vectors effecting multiple organ systems. In an age of predatory profiteering medicine------these gene therapies are EASY to sell early in life the idea of prevention later in life-----these doctors will not be around later in life when we find these therapies did nothing for prevention.
Gene therapies offer dramatic promise but shocking costs
An experimental gene therapy treatment helped Allison Corona, shown in her Glen Head, N.Y., home, regain some of her vision. (Jesse Dittmar for The Washington Post)
By Carolyn Y. Johnson and Brady Dennis November 11, 2015
Email the author For most of her life, Allison Corona lived in a world dimmed by bad genetic luck. A disease called Leber’s congenital amaurosis left her legally blind at age 4. She could not navigate the short distance from her driveway to her front door after dusk.
Three years ago, Corona, now 23, received an experimental medical treatment aimed at fixing the faulty genes in her eyes. Researchers at the Children’s Hospital of Philadelphia injected viruses carrying a good copy of her errant gene into her right eye and, nine days later, her left eye.
The world around her, once dark and austere, soon grew brighter. Her vision is still far from perfect, but for the first time, she sees that paper towels have texture. She marvels at the velvet floral wallpaper that covers her bedroom wall. She takes a college class that gets out at 10:30 p.m. and no longer fears getting stranded in the night.
“Things became much more beautiful for me,” Corona said.
First tested in patients a quarter-century ago, gene therapy — a risky approach aimed at fixing the malfunctioning genes at the root of some diseases — is finally emerging from its own darkness after weathering high-profile tragedies, including the death of a teenage patient.
Research scientist James Wilson. (Chris Goodney/Bloomberg)As it evolves from experimental to applied medicine, gene therapy might soon find itself steeped in a new controversy: soaring drug prices. No therapy is approved yet in the United States, so discussions about price — as well as crucial questions about how much patients will pay directly — are hypothetical. But industry leaders are already talking about ways to get ahead of potentially massive one-time price tags that could make insurers and patients balk.
A gene therapy approved in Europe in 2012 costs close to $1 million, and prices are expected to follow suit in the United States. The therapies in the pipeline are mostly for rare genetic diseases: sickle cell, hemophilia or immune deficiency. Their likely high prices stem from the expected value; unlike drugs that a person takes regularly, gene therapies are designed to be given once and have lasting effects.
But everyone involved anticipates the potential backlash against a seven-figure price tag, which is leading to radical proposals. Instead of paying for a treatment all at once, insurers and patients could make installment payments as long as the therapy works, similar to a mortgage on a house. Some researchers are adding up the cost of the traditional treatments that a patient will be able to avoid each year to determine a price that, although high, could lead to savings for the health-care system.
To Corona, the gift of vision is something approaching a miracle. But how much is that miracle worth in dollars?
In the 1980s, a daring idea seized the imagination of scientists and physicians. What if they could design a drug that wouldn’t just treat the symptoms of a disease caused by a mutant gene, but could instead replace the gene with one that worked normally?
Gene therapy was technically difficult but conceptually simple. Scientists would modify a virus so that when it infected a cell, it would ferry in the correct version of a broken gene.
If the process worked, doctors would have a powerful weapon against rare but devastating maladies such as cystic fibrosis and “bubble boy” disease, which leaves children without immune defenses.
As basic research moved forward, excitement about gene therapy soared. But, as with many new biomedical technologies, that initial exuberance would die down as the powerful idea of replacing broken genes collided with the inherent complexity of human biology. For gene therapy, the blip wouldn’t be just a scientific setback fought out on the pages of scientific and medical journals, but an international scandal in which patients were harmed and public faith was shaken.
In 1999, an Arizona teenager named Jesse Gelsinger died after he experienced an unexpected, severe immune reaction while participating in a clinical trial of gene therapy led by researcher James M. Wilson at the University of Pennsylvania.
“Everybody sort of stepped back and said, ‘Okay, we really have to consider, now that gene therapy has lost its innocence, what are we doing here? And what are the ways in which, if we’re going to do additional experiments, we don’t let this happen again?’ ” Francis Collins, director of the National Institutes of Health, said recently. “It was big; it was very big. I would not be surprised if some young scientists who were thinking of going down this path decided to do something else.”
Wilson became the subject of legal action and scathing media coverage. The government restricted his work on human subjects. Lawmakers on Capitol Hill held hearings to probe the lack of oversight and the ethical lapses that had marked some gene-therapy trials. Gelsinger’s father, Paul, told one Senate panel in 2000, “The concern should not be on getting to the finish line first but on making sure no unnecessary risks are taken, no lives filled with potential and promise are lost forever, no more fathers lose their sons.”
Also in the early 2000s, a few patients in a French gene-therapy trial developed leukemia. Along with the Gelsinger case, it proved a tipping point. Private investment in the field rapidly dried up, and it entered what Cowen & Co. Managing Director Phil Nadeau calls a “nuclear winter.” Regulators halted dozens of trials. To many, gene therapy seemed close to dead; a field of science that had been on a fast track appeared to have been relegated to little more than an interesting academic pursuit for a small cadre of researchers.
With less money, less hype, and much more humility and caution, Wilson and other researchers searched for ways to improve the safety of the viruses used to insert genes.
“It was a realization that the technology we had, which was on the shelf when we began the field, was inadequate for this field to move forward in any substantive way,” Wilson recalled. “It was really to go back to the drawing board, for me. That was a complete reorganization of what I was doing, how I was doing it, the kind of people who worked for me. It was a complete reboot.”
Gene therapy’s comeback started with a trickle. In 2008, researchers reported that a small number of patients with an inherited form of blindness gained modest improvements in vision with gene therapy. Not long after, gene therapy restored immune function in eight of 10 children with typically lethal “bubble boy” disease.
Katherine High, a researcher at the Children’s Hospital of Philadelphia who worked on one of the early blindness trials, started getting cold calls from investors and from pharmaceutical companies, asking if they could partner with her. Then the team of experts she had assembled in Philadelphia began to get job offers.
“I remember very clearly, around 2011, I began to think to myself, ‘If we don’t form a company so we can all stay together, I’m going to lose these people,’ ” High said. She co-founded Spark Therapeutics, which went public this year and is sponsoring the trial in which Corona participated. The company is expected to put its blindness therapy before U.S. regulators, likely next year.
It’s one of many companies with treatments in the pipeline. UniQure’s drug, Glybera, in 2012 became the first gene therapy approved in Europe, for a rare metabolic disease. Bluebird Bio, a biotechnology company that went public in 2013, is developing a variety of gene therapies, including a treatment for a genetic blood disease. Regenxbio, where Wilson serves as chief scientific adviser, went public in September.
“This is only the beginning of what’s going to be a remarkable era in medicine,” Wilson said. “But if it’s the beginning, that suggests there’s significant room for improvement. That means there will be failures and there will be successes.”
On the precipice of having a treatment finally make it onto the market, gene therapy faces yet another controversy: price.
Although much of the current outrage has been spurred by companies that take old drugs and jack up their prices, the potential sticker shock from a million-dollar drug — even if it’s for a previously incurable disease — is sure to raise some of the same questions from politicians and the public.
Nadeau, of Cowen & Co., said his firm has estimated that Spark Therapeutics’ gene therapy will cost $500,000 per eye. A study published last year in the journal Nature Biotechnology examined current health-care spending on hemophilia B and found that a gene therapy could conceivably be priced as a one-time payment of $4 million to $6 million. The authors argued that paying $150,000 a year as long as the drug works could potentially save the health-care system money.
Spark Therapeutics chief executive Jeffrey Marrazzo is reluctant to talk about a dollar figure, but he does think it’s time to consider changes in the way the health-care system pays for treatments.
The options being discussed include a down-payment model, with annual payments. University of Washington economist Anirban Basu has proposed an alternate health currency, HealthCoin, that insurers pay for when buying a cure and then sell to another insurance plan at a depreciated price if a patient switches insurers or becomes eligible for Medicare.
The feasibility of these plans remains uncertain. But gene-therapy executives are arguing that, even at unprecedented prices, their drugs will save the health-care system money — and carry other benefits.
“How do we recognize that there’s truly something that’s important and valuable to people, not only to have certain aspects of their vision restored, but . . . to have it done once and then have the ability to go on with their lives?” Marrazzo said.
Corona, who excitedly woke up her family in the middle of the night when she read about the possibility of gene therapy years ago, didn’t have to pay for her treatment, because she was part of a clinical trial.
But she said her family would have found a way to get her the therapy if it had already been on the market, even if it meant battling an insurance company or taking out a loan. After all, she said, it’s not only about seeing better. She now feels like a happier, more confident person. That part feels priceless.