Friday, July 30, 2010
An array of scientists have sued Secretary of the Department of Health and Human Services and NIH over misappropriations of research money. These scientists have challenged new promulgated guidelines to fund more research projects involving human embryonic stem cells than it had previously done. They believe that this promulation unfairly distributes money away from other important funding, for example, research in adult stem cells and other technologies.
Thursday, July 29, 2010
Her son, David Bell was exposed to harmful biological agents while working at Agraquesta, a biotech company. Bell immediately became seriously ill and has been denied directed medical care for his work-related exposures.
Trend spells out some of the problems and fraud that workers face when trying to obtain medical care from dangerous biological exposures at biotech companies. She emphasizes the lack of workers rights in this industry and the dangers of working in the industry.
See her talk here at the National Conference on Biotechnology, Health and Safety, Labor and the Public: http://blip.tv/file/3924484
Despite the fact that Columbia University scientists knowingly performed unethical research and even falsified documents trying to hide their wrong-doing, the FDA fortunately recently caught them…red handed.
And even more fortunately, the New York Times found out about it six months later, publishing an article entitled, “Studies Halted at Brain Lab Over Impure Injections”.
What are the ramifications to Columbia University for knowingly performing four years of unsafe research on human subjects?
Not much. The only notable change was that top level scientists involved in this debacle got re-assigned….not terminated…no jail time…just reassigned. Woweeee. That is really a hardship.
Hmmmm. And we wonder why these types of unethical practices are common place and condoned in the ivory towers of the academic community?
Columbia University is not above controversy. For example, to get a competitive lead on human embryo research, they have instituted unethical practices of paying women for egg donation. Egg donation is not a procedure without serious risks, risks that many women are really not aware and risks that unfortunately have caused harmed. Again…more unethical practices and disregard for human rights and human dignity.
Columbia University receives millions of dollars of public funding to carry on their research. Columbia University also receives million of dollars from pharmaceutical companies to do their bidding on drug testing too, which coincidently, was part of this four year unethical brain research debacle mentioned above. These types of pharmaceutically-funded research arrangements, unfortunately, often cause conflicts of interests where public health and safety is left behind for commercialization and money-driven incentives.
The public is becoming more and more aware that academic institutions have too strong of monetary ties with industry which thwarts public health and safety advocacy.
And the public is beginning to question why we keep giving public funds to institutions that show blatant disregard for public health and safety, that being involved with either clinical research practices, worker safety, injured workers or human rights issues.
The public is in desperate need for research institutions that will serve public health and safety and advocate for public rights.
Perhaps it is time to rethink public funding to academic institutions that do not advocate for the public.
Wednesday, July 28, 2010
Research Committee Report on Diagnosis and
Chronic Inflammatory Response Syndrome
Caused by Exposure to the Interior Environment of
Water-Damaged BuildingsJuly 27, 2010
Also see this link concerning legal quagmire for mold victims
On third try, House passes $84 billion bill for science and technology programs
The Associated Press
By JIM ABRAMS Associated Press Writer
WASHINGTON May 28, 2010 (AP)
See link: http://abcnews.go.com/Technology/wireStory?id=10774559
This $84 Billion is in excess of the $32 Billion per year already approved for funding of science through NIH.
Katie Couric says we need to “find common ground between ethics and science, a compromise that everyone can live with and that might save lives”. Couric is right on. But her example into the bioethics of science is limited.
The ethics behind science is not limited to the ethical dilemma of using and funding human embryos for research. It has far reaching implications into other aspects of science.
Unfortunately these far-reaching implications are what the public does not quite yet understand. And it is dangerous ignorance.
Advanced technologies in nanotechnology, genetic engineering and synthetic biology are being developed and commercialized today at the expense of public health and safety. These technologies can also have dangerous and negative effects upon public. This is an ethical issue.
It is an ethical issue when science is advanced without appropriate risk assessment and safety protections for the public. It is an ethical issue when laws are made to prevent public transparency from understanding these issues or even preventing research into these safety aspects of advanced technologies. But it is happening today.
It doesn’t stop there. Ethics surrounding science is also about the loss of public rights with patenting of life, about scientists making profit off publically funded research, about conflicts of interests within academia, government and private industry which culminate into money making instead of life-saving research, about the public not having access to science publications that they fund, about how trade secrets supercede worker safety, public health and safety and human rights and about the lack of scientist’s rights to speak out regarding dangerous technologies that impact our health and society.
Ethical issues surrounding science are not being given adequate coverage in the media. And unfortunately when a scientific issue does get coverage, the coverage appears unbalanced, providing all the potential benefits of what science can offer, but then hardly ever providing the public a good understanding of the public safety and ethics involved.
Because the “ethical” issues underlying science are being put aside and even silenced in some cases, the public is slowly but surely losing more and more legal rights and human rights as technology advances. For example, we have lost the right to have our food properly labeled as genetically modified or not.
But the public should have the right to understand these ethical issues since they fund approximately $32 Billion dollars a year toward general biomedical research. That is a lot of money pulled from the taxpayer pocket.
Ethical issues related to science may not always be black or white. But they still deserve public transparency and debate since in some instance scientific technologies can create greater harm then good.
Couric is right in bringing to light the issue of balancing ethics and science. She is wrong, however, in limiting her ethical example to the embryonic stem cell, an issue that has historically been branded with divisiveness, extremism and propaganda, an issue that has caused a break in public awareness and adequate discussions in bioethics as a whole.
Nevertheless, Couric has to be acknowledged in hastening the public to be more aware of the importance of understanding the ethics behind science.
Tuesday, July 27, 2010
Dr. Larry Rose, M.D. a former OSHA physician spoke at the Conference on Biotechnology, Health and Safety, Labor and the Public held in San Francisco recently. Dr. Rose talked about the problems he incurred working at OSHA and the problems that exist today. He gave a good overview of how OSHA has become dysfunctional: Understaffing 1 to 90,000 workers, lack of expertise, diminished strength of unions and repressive political appointees who are pro corporate are all major factors in OSHA’s demise.
Dr. Rose also speaks on the secrecy of biological exposures and lack of public transparency, thereby making biotech appear safe, when in fact, it is dangerous work for the worker and the public.
Dr. Rose believes we have some good standards for protections of workers, but unfortunately, OSHA does not enforce the standards, leaving workers and the public at risk.
See Dr. Larry Rose's talk at the Conference on Biotechnology, Health and Safety, Labor and the Public held in San Francisco on July 17, 1010 at: http://www.blip.tv/file/3916683
Exploring Algae as Fuel
By ANDREW POLLACK
July 26, 1010
SAN DIEGO — In a laboratory where almost all the test tubes look green, the tools of modern biotechnology are being applied to lowly pond scum.
Foreign genes are being spliced into algae and native genes are being tweaked.
Different strains of algae are pitted against one another in survival-of-the-fittest contests in an effort to accelerate the evolution of fast-growing, hardy strains.
The goal is nothing less than to create superalgae, highly efficient at converting sunlight and carbon dioxide into lipids and oils that can be sent to a refinery and made into diesel or jet fuel.
“We’ve probably engineered over 4,000 strains,” said Mike Mendez, a co-founder and vice president for technology at Sapphire Energy, the owner of the laboratory. “My whole goal here at Sapphire is to domesticate algae, to make it a crop.”
Dozens of companies, as well as many academic laboratories, are pursuing the same goal — to produce algae as a source of, literally, green energy. And many of them are using genetic engineering or other biological techniques, like chemically induced mutations, to improve how algae functions.
“There are probably well over 100 academic efforts to use genetic engineering to optimize biofuel production from algae,” said Matthew C. Posewitz, an assistant professor of chemistry at the Colorado School of Mines, who has written a review of the field. “There’s just intense interest globally.”
Algae are attracting attention because the strains can potentially produce 10 or more times more fuel per acre than the corn used to make ethanol or the soybeans used to make biodiesel. Moreover, algae might be grown on arid land and brackish water, so that fuel production would not compete with food production. And algae are voracious consumers of carbon dioxide, potentially helping to keep some of this greenhouse gas from contributing to global warming.
But efforts to genetically engineer algae, which usually means to splice in genes from other organisms, worry some experts because algae play a vital role in the environment. The single-celled photosynthetic organisms produce much of the oxygen on earth and are the base of the marine food chain.
“We are not saying don’t do this,” said Gerald H. Groenewold, director of the University of North Dakota’s Energy and Environmental Research Center, who is trying to organize a study of the risks. “We say do this with the knowledge of the implications and how to safeguard what you are doing.”
At a meeting this month of President Obama’s new bioethics commission, Allison A. Snow, an ecologist at Ohio State University, testified that a “worst-case hypothetical scenario” would be that algae engineered to be extremely hardy might escape into the environment, displace other species and cause algal overgrowths that deprive waters of oxygen, killing fish.
A week earlier, at an industry-sponsored bioenergy conference, David Haberman, an engineer who has worked on an algae project, gave a talk warning of risks. Many scientists, particularly those in the algae business, say the fears are overblown. Just as food crops cannot thrive without a farmer to nourish them and fend off pests, algae modified to be energy crops would be uncompetitive against wild algae if they were to escape, and even inside their own ponds.
“Everything we do to engineer an organism makes it weaker,” said Stephen Mayfield, a professor of biology at the University of California, San Diego, and a co-founder of Sapphire. “This idea that we can make Frankenfood or Frankenalgae is just absurd.”
Dr. Mayfield and other scientists say there have been no known environmental problems in the 35 years that scientists have been genetically engineering bacteria, although some organisms have undoubtedly escaped from laboratories.
Even Margaret Mellon of the Union of Concerned Scientists, who has been critical of biotech crops, said that if genetically engineered algae were to escape, “I would not lose sleep over it at all.”
Still, some algae researchers worry they will be engulfed by the same backlash aimed at biotech foods and say care must be exercised. “About 40 percent of the oxygen that you and I are breathing right now comes from the algae in the oceans,” the genetic scientist J. Craig Venter said at a Congressional hearing in May. “We don’t want to mess up that process.”
Dr. Venter’s company, Synthetic Genomics, is getting $300 million from Exxon Mobil to create fuel-producing algae, in part by using synthetic genes. When the two companies cut the ribbon on a new greenhouse here earlier this month, Dr. Venter assured local dignitaries in attendance that no algae would escape. “Nothing will go into the drains, Mr. Mayor,” Dr. Venter said, only half-jokingly. “San Diego is safe.”
In the long run, Dr. Venter said, the algae should be given “suicide genes” that would kill them if they escaped the lab or fuel production facility. Some companies are sticking with searching for and breeding natural strains. “Re-engineering algae seems driven more by patent law and investor desire for protection than any real requirement,” said Stan Barnes, chief executive of Bioalgene, which is one of those companies. But Dr. Venter and Mr. Mendez argue that there are huge obstacles to making algae competitive as an energy source and that every tool will be needed to optimize the strains.
Sapphire Energy seems one of the best-positioned companies to do that. The company, which is three years old, has raised $100 million from prominent investors, including Bill Gates. Sapphire is also getting $100 million in federal financing to build a demonstration project containing 300 acres of open ponds in the New Mexico desert.
The company has inserted a gene into algae that allows the organisms to make a hydrocarbon they would not naturally produce, one that would help make fuel. “You don’t want to take what algae gives you,” said Mr. Mendez, who previously worked for medical biotechnology companies. “You want to make the best product.”
The company is also developing algae that can thrive in extremely salty and exceedingly alkaline water.
It has even developed what might be called Roundup Ready algae. Like the widely grown Roundup Ready soybeans, these algae are resistant to the herbicide Roundup. That would allow the herbicide to be sprayed on a pond to kill invading wild algae while leaving the fuel-producing strain unhurt.
Not all these traits are being developed by genetic engineering, because in many cases scientists do not know what genes to use. Instead, the company screens thousands of strains each day, looking for organisms with the right properties. Those desirable traits can be further enhanced by breeding or accelerated evolution.
In one room at Sapphire’s lab, parallel tubes contain algae with identical traits growing under identical conditions. But each strain is slightly different, and only the fastest growing one — determined by which tube turns the darkest green — will be chosen for further development.
“If you can’t outcompete your wild cousin, it doesn’t make it out of this room,” said Mr. Mendez. Algae can reproduce rapidly, doubling in as little as a few hours. And they can be carried long distances by the wind. “They have the potential to blow all over the world,” said Richard Sayre of the Donald Danforth Plant Science Center in St. Louis.
Dr. Sayre, who is also chief technology officer of Phycal, an algae company, is using genetic engineering to develop algae that capture less light. Right now, he explained, algae capture more light than they need and waste a lot of it as heat. If each organism captured less, then a given amount of light could be shared by more organisms, increasing biomass production.
Instead of using open ponds, some companies are using bioreactors, which typically contain the algae in tubes. Some experts say, however, that these would not totally prevent escapes. “The idea that you can contain these things and have a large-scale system is not credible,” said John R. Benemann, an industry consultant in Walnut Creek, Calif. He said, however, that he saw absolutely no risk from genetically engineered algae.
Sapphire says it is not growing any genetically engineered algae in open ponds yet. When it is ready, it says, it will comply with all regulations.
Genetically engineered algae, whether in open ponds or enclosed bioreactors, are likely to be regulated by the Environmental Protection Agency, which now regulates genetically engineered microbes under the Toxic Substances Control Act.
Still, there has been at least one case in which genetically modified algae seem to have fallen between the regulatory cracks. When Mera Pharmaceuticals, which is based in Hawaii, wanted to test the feasibility of producing human pharmaceuticals in genetically engineered algae in 2005, none of the three federal agencies that regulate the various areas of biotechnology — E.P.A., the Food and Drug Administration and the Agriculture Department — claimed jurisdiction.
Steven G. Chalk, acting deputy assistant secretary for renewable energy at the Energy Department, said any federally financed project, like Sapphire’s New Mexico demonstration, would have to undergo an environmental assessment. But risks would be assessed case by case, he said, not for all conceivable genetically modified algae.
http://www.nytimes.com/2010/07/26/business/energy-environment/26algae.html?_r=1&scp=2&sq=not just pond scum&st=cse
Public health officials have been working for months to understand whether the XMRV virus poses a risk to the nation’s blood supply. The concern was sparked by a paper published last year in Science that detected the virus in the blood of 67% of chronic fatigue syndrome patients, compared to just 3.7% of healthy controls. For more....click here
Saturday, July 24, 2010
An interesting article appeared this month in the Wall Street Journal regarding the problem the middle class now faces in finding and affording legal help.
This is a major problem in our country today. The result is that many bad corporations and powerful entities are getting away with murder...because they can.
Here is the link to the WSJ story entitled: More Strapped Litigants Skip Lawyers in Court.
The scientific misconduct occurred in Dr. Larry Pease's lab where molecular immunology research was performed. It has been alleged that a scientist, Dr. Suresh Radhakrishnan in Pease's lab has falsified data. Dr. Radhakrishnan denies any wrong doing.
The question remains, however, how can 8 years of continuous research go forward without finding the falsified data and the problem sooner?
More details are needed regarding getting to the facts of this story to really find out what has happened.
Here are links to some details:
Before World War II there was very little government funding of science, but that changed because of war-time necessities. In 1951, the U.S. National Science Foundation (NSF) was established to provide support for post-World War II scientific research. The methodology for administrating science-funding, invented in the early 1950s by NSF, has been adopted essentially unchanged by virtually all subsequent U.S. Government funding agencies, such as the National Aeronautics and Space Administration (NASA) and the U.S. Department of Energy (DOE). The problem is this: That methodology is flawed and those flaws have been gradually undermining, corrupting, and trivializing American science for decades. Here I disclose the principal flaws and point the way for the President of the United States to correct them."
"We're concerned that if dengue gains a foothold in Key West, it will travel to other southern cities where the mosquito that transmits dengue is present, like Miami," Harold Margolis, chief of the dengue branch at the U.S. Centers for Disease Control and Prevention, said in a CDC news release.
Dengue — the most common virus transmitted by mosquitoes — causes up to 100 million infections and 25,000 deaths worldwide each year. Between 1946 and 1980, there were no reported cases of dengue acquired in the continental United States, and there hasn't been an outbreak in Florida since 1934, the CDC said.
Dengue fever typically involves a high fever, headache, rash and pain in the muscles, bones and joints. Infection can, in rare cases, lead to a more severe illness called dengue hemorrhagic fever, which can prove fatal. There is no vaccine against dengue viruses.
"These cases (in Key West) represent the re-emergence of dengue fever in Florida and elsewhere in the United States after 75 years. These people had not traveled outside of Florida, so we need to determine if these cases are an isolated occurrence or if dengue has once again become endemic in the continental United States," Margolis said.
Since 1980, there have been a few locally acquired dengue cases in Texas along the Mexican border. These cases coincided with large outbreaks in neighboring Mexican cities, the authors of the news release noted.
Health officials started looking for dengue in Key West after a New York state resident developed a dengue infection after visiting Key West. By the end of 2009, 27 cases of dengue infection had been confirmed in Key West residents. As of the end of June 2010, an additional 12 cases of locally acquired dengue had been reported in Key West and surrounding areas.
Blood samples collected in 2009 from 240 people in randomly selected households in Key West found that 5% had dengue active in their systems or had dengue antibodies, suggesting that they'd experienced dengue disease within the previous three months.
As a result, officials at the CDC and the Florida Department of Health have continued monitoring for dengue cases in the Key West area.
"The mosquito that transmits dengue likes to bite in and around houses, during the day and at night when the lights are on," Margolis said. "To protect you and your family, CDC recommends using repellant on your skin while indoors or out. And when possible, wear long sleeves and pants for additional protection."
Thursday, July 15, 2010
A recent legal ruling which invalidates patents for BRCA1 and BRCA2 held by Myriad Genetics make a precedent setting case. Below is a a good article from Biotechwiz blog:
The current judgement is a 156 page decision and invalidates about seven of the patents held by the company Myriad Genetics related to the BRCA1 and 2 genes that have been implicated in breast and ovarian cancers. If this decision is upheld by the Higher courts, it has the power to completely challenge many of the existing gene patents and change the face of Intellectual property law as we know it forever.
So what really is a gene patent. Wikipedia defines it thus: A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims. Thus in essence, a gene existing within an organism is not patentable and neither is it of any use to us clinically if it remains as such. The moment it has been isolated, purified, it can be put to commercial use, as in for diagnosing clinical conditions such as cancers or treating them. This was presumably the premise underlying the grants of such patents in the first place. However, the premise seems to be rather ridiculous to me. Most of the genes under patent protection today (about 20 % of the genome is patent-protected) are not inventions but discoveries. If the mere act of isolating them from the body turns them into something ”novel” , then by that token a large number of chemical entities can be considered novel by simply isolating them from their parent source. This will lead to patents on a large number of ridiculous ‘inventions’. Writer Michael Crichton makes an emphatic point in an article in the New York Times. He says and I quote,” Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn’t somebody make a cheaper test? Sure, but the patent holder blocks any competitor’s test. He owns the gene. Nobody else can test for it. In fact, you can’t even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it’s now private property.”
I am sure most of my readers would agree with me that this situation is bizarre. It begs the question how could the USPTO be so irresponsible as to grant such patents in the first place? In the current ruling, Myriad Genetics, that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit. However, Judge Sweet made the point that such patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
In an important observation, the court ruled as follows, “The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.”
While browsing the net I came across an interesting perspective on the judgement, I quote from the author’s post, “This lawsuit against Myriad signifies a change in that it finally places the patient and the administration of genetic testing at the centre of the stage. Although the Court’s holding focuses on patent subject matter the court dedicates a significant part of the opinion to access to BRCA1/2 genetic testing. Myriad charges about $3,000 for testing an exorbitant amount compared to other genetic tests. Furthermore, Myriad does not allow other laboratories to conduct the testing – all samples have to be sent to its headquarters in Salt Lake City. The opinion tells the stories of women who were unable to test to find out whether they carry the BRCA1/2 genes because Myriad would not accept their insurance. It recounts the ordeals of women who could not get definitive answers through Myriad’s testing and were precluded from seeking testing elsewhere. It underscores that women were unable to get a second opinion of the test results because tests are conducted only by Myriad. It also discusses the efforts of doctors and laboratories that were willing and able to offer BRCA1/2 testing but were precluded by Myriad from conducting the testing.”
Many are not comfortable with the idea of patenting genes. Michael Crichton in his article talks about the need to have open access to information. He cites the poignant case of a disease known as Canavan Disease. This is a debilitating disease that is inherited and in which infants are unable to crawl or walk, suffer seizures and rarely survive beyond their adolescence. He goes on to document the ironic and heart-breaking history of the research that led to the development of the diagnostic test for this disease. Because of the lack of such a test in the first place, families who had borne children with the Canavan disease came together and donated tissue samples for study. They engaged a researcher to identify the gene and donated their time and money for the same. Eventually the efforts met with success. The gene was identified in 1993. The families managed to get the commitment of a New York Hospital that it would offer a diagnostic test for the defective gene to anyone who needed it for free. In a twist of fate however, the employer of the hospital, Miami Children’s Hospital Research Institute patented the gene and refused to allow any health care worker to use the test without paying a royalty. The families who had contributed did not believe in patenting and so did not put their names on the patent and consequently had no claims whatsoever on the fate of the research.
If companies were denied access to essential material for research like for example tissue and blood samples or even clinical data or the questionnaires filled out by the patients and/or their families, would they be able to pursue their research at all? Let alone come to a point where their “inventions” become money spinning prospects for the companies? If recognising their efforts and granting them patent protection means that they are going to use this as a license to charge whatever they please for the tests, prevent anyone else from coming up with a cheaper alternative and effectively making efficient healthcare the privilege of the few, I think this goes against the spirit of the law.
This is exactly the position taken by Judge Sweet in the above landmark decision. He has placed emphasis on the fact that accessibility of genetic testing is a key concern and that granting patent protection for superfluous claims is a dangerous trend. Whilst not passing any ruling on the larger constitutional issue of why the USPTO granted such patents in the first place, he has underscored a larger more important issue; One of the plight of the patients. It is more important now that we learn to strike a balance between protecting an inventor and the extent to which this protection should be granted in the face of abuse of exclusive rights and grants.
In 2007, the European Patent Office (EPO) rejected an appeal by Myriad Genetics and the University of Utah, and upheld an earlier decision to revoke some claims of patent EP705902 relating to the BRCA1 gene and its applications. There was widespread objection to the extent of this claim among European researchers, since it granted an effective monopoly to Myriad which they believed unjustified; six bodies filed objections, leading to a decision by the EPO in 2005 to substantially amend the patent, retaining only the claims relating to a specific nucleic acid probe and vectors containing gene sequences. The EPO has now rejected an appeal by Myriad and the University of Utah, and amended the patent, meaning that European laboratories retain the right to perform diagnostic tests for mutations in the BRCA1 gene sequence, which are associated with increased susceptibility to breast and ovarian cancer.
Thus, in countries where gene patenting is not recognised, testing facilities can be made cheaper and probably even more efficient than the original one. The point that we need to mull over here is this: can there be another method to make this system work for both the researchers and the end-users? For example, can we reduce the term of patent protection in such cases or put a ceiling on how much a company with patent protection can charge for a particular test/ treatment so that it covers its costs but does not profiteer and do so at the expense of patients for whom the research was meant to be in the first place. Also, if a company is found to be recklessly profiteering, can we not have punitive measures for the same? Or make exceptions in costs for patients who might not be able to spend so much for a single diagnostic test? If a patient desires to have another lab carry out the test in order to verify/ confirm/ have a second opinion, instead of the patent owning company blocking it out, can it not work out a cost sharing with other laboratories so that the system becomes more transparent?
This is one of those questions that begs deeper debate. We cannot afford to get defensive or offensive and merely argue. This problem needs urgent and fair solutions. One the one hand, the fate of Biotechnology companies hangs in the balance, as experts say newer companies will find it difficult to raise venture capitalist funding if they are not sure they will get strong patent protection. On the other, monopolistic patent protection granted on frivolous grounds is like playing with the lives of patients. I laud Judge Sweet for his gumption in giving the kind of decision that he has. It is indirectly a comment on the haphazard and mindless policy of the USPTO (contrast this with the behaviour of the EPO on the same issue).
I will write another article where I will attempt to analyse a few aspects of the judgment. But as for now, I will content myself with just saying this…… We are at the brink of a major change. How we use this opportunity will decide our fate in more ways than one!
4. http://www.pbs.org/wgbh/pages/frontline/shows/snitch/procon/sweet.html ( A general Interview with Judge Robert Sweet)
Tuesday, July 13, 2010
What is nanotechnology? Why is it dangerous? Let’s review a bit….
Nanotechnology is still in its infancy. It is a science where scientists intend to build molecular structures one molecule at a time…from the bottom up…so to speak. It is an interdisciplinary science of the physical sciences, life sciences, computer informatics and engineering sciences. Nanotechnology is also part of synthetic biology where scientists intend to create synthetic life forms by designing and creating nano-biological machines and components and placing them inside cells.
Nanotechnology engages in building molecular structures and creating new materials at the nanometer level.
That size is very small. Building structures that are nanometers in size is comparable to 1 million times smaller than the head of a pin or about 2500 times smaller than a red blood cell. The size of a nanometer is about the size of the diameter of a DNA molecule.
The smallness of these nanoparticles makes them both beneficial and dangerous. Their potential benefit is in the ability to use this technology for medical and health sciences with potential to diagnose and cure disease. Nanotechnology also can be used in consumer goods making materials stronger and lighter or having other useful properties. They are already being used in clothing, paint, makeup and sunscreen. They are also being used in semi-conductor research with hopes of making electronics and computers better and faster.
The dangers of nanotechnology lie in the fact that nanoparticles can also unpredictably react with human life, other life and the environment causing harm…serious harm.
Nano- materials behave differently because they are so small compared to a larger or macro scale. They are under the influence of different physical forces…more toward quantum mechanics than gravity. This gives nano-particles different chemical and physical properties. Therefore, nanomaterials are more reactive and more bioactive. They can be toxic and cause cancer. They could be passed from mother to fetus. Nano-particles can exhibit other properties too. For example, copper loses its opaqueness and becomes transparent when produced on a nanoscale. Aluminum, stable at the macro level, becomes combustible when produced as a nano-particle.
Nanoparticles cause risk to humans since their size allows them to more easily cross the skin, lung or blood brain barrier.
Despite these obvious threats, scant research is being invested into nanotech health issues. The little research done has caused alarm. Fish exposed to nanoparticles have been found to have extensive brain damage. Nanoparticles have been found to accumulate in the bodies of lab animals which makes a link to possible food chain accumulation if nanoparticles are released into the environment. Nanoparticles called quantum dots can cause cadium poisoning in humans. Nano-particles have been found in the brain and lung tissues of rats exposed to nano-particles and subsequently caused inflammation and biochemical stress responses.
More concerning is that nanoparticles, because of their small size, could enter into the environment or life forms without detection.
Nanotechnology is big business. The government is funding it at $1.5 Billion per year and industry is adding another $8 Billion per year. There are about 1650 nanotechnology companies world wide with the majority located within the U.S.
Powerful economic forces and competition in the marketplace are taking precedence over safeguards when it comes to protecting workers and the public against the possible dangers of nanotechnology. This is causing some scientists and public to become concerned.
Dr. Franco Cerrina found dead within the laboratory raises questions regarding the cause of his death. Was it due to a work-related illness? It is very possible…but we most likely will never find out.
Monday, July 12, 2010
An interesting point in the article is made when it hypothesizes that the government can't get tough on Pfizer by preventing Pfizer to sell drugs to Medicare, Medicaid and VA. "The government is not really in a position to be cutting itself off from all that medicine."
Why not? Why can't unethical companies loose patent rights when they use unethical business practices? Why not let a different, but ethical company make the same drugs and sell them to Medicare, Medicaid and the VA?
Although the article is good, Rosenberg forgets to mention, however, that after Pfizer was fined 2.3 Billion dollars for unethical business practices by the US government, Pfizer CEO Jeffry Kindler was appointed to the Federal Reserve Bank of New York. The Federal Reserve is one of the single most influential bodies for setting US monetary standards and policy in the United States. Hello...anyone home?
Rosenberg's article is below:
By Martha Rosenberg, AlterNet Posted on July 10, 2010, http://www.alternet.org/story/147467/
By Martha Rosenberg, AlterNetPosted on July 10, 2010, Printed on July 12, 2010http://www.alternet.org/story/147467/
The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.
But the "world's largest research-based pharmaceutical company" which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.
To say Pfizer's been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson's disease, kidney transplants and leukemia.
Saturday, July 10, 2010
But in collaboration with the social critic Jeremy Rifkin, president of the Foundation on Economic Trends in Washington, D.C., decided to force the issue by applying for a patent in late 1997 on embryos and animals containing human cells — so-called “chimeras.”“Chimeras” are creatures composed of the cells of two genetically different individuals, usually combined at the embryonic stage. There are rare natural human chimeras who are born when the embryonic cells of fraternal twins combine in the womb to create a single individual. Scientists have also deliberately created cross-species chimeras like the “geep,” in which embryonic cells from goats and sheep were combined. The contemporary view suggests from the Greek meaning “she-goat” the Chimera is a fire-breathing creature that has the body of a goat, the head of a lion and the tail of a serpent. Some sources have represented the Chimera with three heads (the lion’s head as the main, then the goat’s head sprouted from its back, and the serpent’s or Dragon’s head on its tail), but the popular myth tells of the single, fire-vomiting head. The very unlikely aspect of the chimera has gradually turned its name into a synonym of a vain dream.
Leading anti-biotech activist have long opposed corporations “owning” patents on living organisms (or on cells and genes). But do corporations really “own” genes or animals? What are patents? Patents are temporary monopolies (20 years) granted by the government to inventors as a way to encourage them to disclose publicly how their inventions work so that other people will be able to use them.
Often reviled by academic researchers, the patent system is actually an information-disclosure procedure that works somewhat like peer-reviewed scientific publication — that is, the first one to publish gets the credit. Like patents, peer-reviewed research must disclose enough information so that other researchers can reproduce the experiment. The temporary monopolies created by patents are valuable, which encourages people to invest in the research and development projects of biotech companies.
A Question Of Chimeras — Activists try to patent fear
Scientists say ruling on protest patent won’t have an impact on future chimeric-animal patents. Looking to cure a host of neuro-degenerative diseases, Stem-Cells, a Palo Alto, Calif.-based company, has transplanted human neural stem cells into the brains of thousands of mice. The mice are technically chimeras, a mix of two or more species.
Such animals, especially mice, have been used to search for ways to cure human diseases including Parkinson and Alzheimer disease. The ability to evaluate human cells in a mouse or other animal is critical to translating scientific discoveries into therapeutic medicine, thus the bridge to the clinic. However, the use of such chimeric animals is the focus of a complicated patent case that is raising legal and ethical questions. In this case, opponents to the patenting of living things applied for a chimera patent. The US Patent and Trademark Office (USPTO) refused to issue a patent for the human-animal chimera in the application, on the grounds that it would have been too nearly human.
In the volatile debate over bioengineered life forms, many disagree about the ramifications of the recent case. The critics of the biotechnology industry who applied for the patent say the case has serious business and research implications. But some leading scientists and industry observers say the case is just another effort to grab attention in a field rife with more heat than rational discussion. Stuart Newman, a professor of cell biology and anatomy at New York Medical College in Valhalla, says he opposes the patenting of living things. Newman, working with Washington, DC, activist Jeremy Rifkin, filed a patent application in 1997 for a theoretical creature he never actually made. For “tactical reasons,” Newman says he eventually split his patent application into two: one involving primates and the other focused on other animals.
Using what he calls the “embryo chimera technique,” Newman sought to patent a creature combining human embryo cells with cells from the embryo of a monkey, ape, or other animal to create a blend of both. Other scientists have used similar methods to create a “geep” (part goat, part sheep), could be used for drug testing and as a source of organs to transplant into humans. After seven years and several rejections and appeals, the USPTO turned down both of Newman’s patent applications in August 2004, saying, among other things, that this creatures would be too close to human. Newman and Rifkin let the six-month appeals period lapse and declared victory in February 2005. Both Rifkin and Newman say they expect the ruling to prevent scientists and biotechs from obtaining similar patents for 20 years, the time a patent is usually viable. Rifkin says crossing species boundaries is a form of animal abuse and a violation of nature and human dignity.“The ruling has significant implications for the future of the biotech industry,” says Rifkin, president of the nonprofit Foundation on Economic Trends, and one of the most vocal critics of biotechnology products such as genetically engineered organisms.
The implications for commercial interests are far-reaching. It means anyone applying for a patent for human-animal chimeras ought to be turned down. He expects the ruling to affect stem cell researchers, too. There are people who are producing or who express their intention to produce mixtures of humans and mice for research purposes in order to test the potential of human stem cells. This decision does not block their ability to do that in their labs, but if they wanted to patent and market these mixed human and animal organisms, it would be more difficult for them to commercialize it. However, some leading stem cell researchers say the case is unlikely to stop work on chimeric animals.
Twenty-five years ago, in Diamond v. Chakrabarty, a US scientist Ananda Chakrabarty, who worked for General Electric at the time, obtained the first patent on a living organism, a genetically engineered bacterium that consumes oil spills. The patent office originally denied the application, believing it could not patent living organisms, according to Brigid Quinn, USPTO spokesperson. The case landed in the US Supreme Court, which held that “anything under the sun made by man” could be patented as long as it is “new, non-obvious, and useful.”
Since then, more than 436 transgenic or bioengineered animals have been patented, including 362 mice, 26 rats, 19 rabbits, 17 sheep, 24 pigs, two chickens, 20 cows, three dogs, and many more. Many say the 1980 ruling led to the birth of biotechnology in the United States. However, the US law clearly prohibits the patenting of people. One reason we denied the case was the examiner believed one or more of the claims encompassed human beings. The question which can be raised that whether the case will affect future patent applications for chimeric lab animals, the answer may be that the examiners always decide first if it is patentable subject matter and humans aren’t. Anything found in nature is not patentable subject matter. It has to be new, useful, non-obvious, and fully disclosed in writing. Each patent application is reviewed on its own merits.
Thus it cannot be said that whether the case will affect future chimera patent applications or not.Irving L. Weissman, a professor of cancer biology, pathology, and developmental biology at Stanford University has created mice with brains that contain about 1% human tissue. Weissman says recent news reports that he plans to create a mouse with a 100% human brain are “inaccurate.” A pioneer in the field of stem cell research, Weissman is credited as being the first scientist to identify and isolate hematopoietic stem cells from mice and humans. He says that the news reports were fueled by an academic inquiry he made to find out, in theory, what his university ethics panel thought of the idea. He says he has no current plans to create such a mouse.
The Newman/Rifkin patent is “a new attempt to block science,” while the “use of human-mouse chimeras is old,” Weissman says. In 1988, J. Michael McCune patented the SCID-hu mouse, “a severe combined immunodeficient mouse with human organs, bones, lymphoid tissue, thymus, and liver,” says Weissman, who is also director of Stanford’s Institute of Cancer/Stem Cell Biology and Medicine and a cofounder of Stem-Cells and other companies. “The precedent is there, the discoveries are long published, and people’s lives have been affected by those discoveries. Would they take back all those discoveries and be happy if the therapies discovered through them were taken away?” Weissman dismisses the Newman/Rifkin case as “typical Rifkin,” adding that “one example doesn’t hold. It doesn’t invalidate the others, so it’s a hollow victory. The case is not the precedent they think.”
Chimeric animals, and patents, are crucial to a biotech’s ability to develop cures for human diseases. To protect one’s investment, for example, StemCells has more than 43 US patents on its stem cell technology, though none are on bioengineered mice. If the private sector cannot receive a patent on all its work and invention, it’s unlikely to engage in the work because it takes so much time and effort and money. The ability to retain a return on one’s investment is crucial. Thus it can be inferred that mice are the backbone of biotechs, pharmaceuticals, and drug development.
However, adding such complexes of genes to other creatures, say mice, would raise no ethical problems. Why? Because mice simply couldn’t develop humanlike brains with self-consciousness. And such mice might be useful for finding treatments for human brain diseases The essential point is that certain types of brains, not genes, have moral standing. Human genes are not sacred, people are.
The yuckiest thing of all would be if the public and policy makers were frightened by the Frankenstein fantasies peddled by clever activists into slowing biomedical progress that could ameliorate the suffering of millions.
Rethinking scientific and legal precedent
Since the 1980 Supreme Court decision in it has been legal in the United States to obtain a patent on living organisms and their descendants.
Moreover, government has drawn no line that would preclude a pre-term human embryo, if appropriately modified, from being patented. Nor has it indicated how many human genes or cells an animal would have to contain before it could not be patented by virtue of the constitutional protections due to members of the human community.
Can human embryos be patented? The working scientist concerned that the fruits of science not be used to society’s detriment, Rifkin’s invitation of several years ago to invent something novel is eagerly accepted, but also so disquieting that it would alert the public to the inevitable consequences of the unbridled commercialization of the living world. The result was the human-animal chimera, which could contain anything from a minuscule proportion to a majority of human cells.
This creature is not to be produced (and thus did not) but simply had to demonstrate its feasibility. Because it was known that invention was patentable under existing standards and law, it is accepted that a patent would be issued and then there would have the option of exercising the right to prevent its implementation for the statutory 20 years.
It is anticipated that public indignation at the possibility that such part-human, part-animal organisms can be produced and patented might reasonably lead to a re-evaluation of the legalities that have made bona fide commercial ventures of this sort possible.
The new developments are particularly concerned with the precedent of the Chakrabarty case, in which the Patent and Trademark Office (PTO) opposed the granting of a patent to Dr. Ananda Chakrabarty and his employer, General Electric Corp., for an oil-eating bacterium.Courts overruled that decision, ruling, absurdly, that bacteria are “more akin to inanimate chemical compositions … [than] to horses and honeybees and raspberries and roses” and, startlingly, that Chakrabarty’s microbe was “a human-made invention.” Notwithstanding the stated distinction, the Chakrabarty decision served as a precedent for the issuing of patents on mice, pigs and cows, some containing introduced human genes, as well as naturally occurring human bone-marrow cells.
Legislature has not specifically addressed the question of whether the humain beings can be patented or not. Similarly, the court in Chakrabarty did not address whether human beings are patentable subject matter.” The PTO (Patenr and Trademark Office) commented that “when there are paramount patent issues of first impression, in the absence of clear legislative intent and guidance from the courts, it is incumbent on the office to proceed cautiously.”The new circumstances have given an opportunity to finally open up the question of whether or not the PTO’s current policy of conferring life patents on genes, cells, etc. is legal. With the PTO now saying that the ranting of certain patents on human cells may in fact be questionable, the question of the legitimacy of life patents becomes an issue of great public policy concern within the government itself.
The question of whether the human gene pool and life itself can be patented is one of the great issues of the coming century. If the current PTO policy is allowed to stand, a handful of global life science companies will gain control over the genetic blueprints of millions of years of biological evolution, giving them awesome powers over the biological marketplace of the 21st century. These legal challenges are designed to block and reverse this potential monopoly over the biology of the planet.
Thursday, July 8, 2010
OBAMA Removes Human Embryonic Stem Cell Restrictions under the Guise of Separation of Science and Politics
President OBAMA removed the government ban on federal funding of hESC (human embryonic stem cell research) in what was described as a move that “is part of the administration’s broader effort to separate science and politics”.
But the politics still remain as the biomedical community continues to use “think tank” media strategies, using the wheelchair bound paraplegic as their poster child to engender sympathy against the human rights issues involved in human embryonic stem cell research.
There is little of a remote chance that embryonic stem cells will provide a therapeutic cure toward paraplegia or quadriplegia. Scientists know it and have known it. But now they strategize by telling the public that “cures won’t happen overnight”…still allowing the desperate to cling on to hopeless hope with the embryonic stem cell.
At the same time the biomedical community avoids any mention of the public safety dangers, lack of regulations and lack of worker rights associated with the embryonic stem cell research. They also would not dare to mention the current use of human embryonic stem cells in our biowarfare laboratories.
Instead the biomedical think tank experts do brilliant work to avoid these issues and in its place exploit the anti-abortion stance to their advantage, painting pro-life groups as radical, against science and unsympathetic to the plight of the disabled.
This has been a good tactic and a successful one, casting shadows on the human rights and safety issues underlying the use of human embryos in research while promising hopeless cures.
While all the time….Human embryonic stem cell research is about big money and big business. Billions of dollars. Period.
Despite what he says, President OBAMA’s move was in a fact, a political move. It will establish policy so that scientists can move ahead without responsibility for public health and safety on the use of human embryos in research and without any realistic ethical constraints. It will limit public transparency, making this research on human embryos more private and secretive. The NIH will make sure it…of course, under their appointed guise of developing “ethical standards.”
In describing his decision to eliminate the ban on federal funding of human embryonic stem cell research, Obama said, “Our government has forced …a false choice between sound science and moral values.” These are fine tuned words that carry a great deception.
Tuesday, July 6, 2010
The plague is a bacterial disease caused by Yersinia pestis. It is transmitted usually to an animal or human through a flea bite. Six centuries ago, the plague was the cause of the Black Death which swept through Europe killing more than 25 million people.
In 1924-1925 Los Angeles had an epidemic of pneumonic plague but was soon placed under control with rat control and urban hygiene.
Since then the disease has moved from the cities to the countryside, finding new animal hosts.
The plague has spread through much of the Western United States and is endemic in certain animal populations.
The plague causing bacteria was recently found in a Denver city park in 2007.
Last month in China, a man died after hunting and subsequently cooking a plague-infected marmot.
Last September, a University of Chicago professor, Dr. Malcolm J. Casadaban, died after a mystery exposure to Yersinia pestis in the laboratory where the plague-causing microbe was studied.
The plague can be highly contagious. Fortunately, the bacterial infection which causes the plague can be treated with antibiotics if diagnosed soon enough. However resistant strains are becoming a major concern.
LA news: http://cbs2.com/local/campground.shut.Los.2.1787742.html
Denver story: http://www.thecherrycreeknews.com/news-mainmenu-2/1-latest/1287-plague-in-denver-city-park-squirrels-infected.html
Global Times: http://china.globaltimes.cn/society/2010-06/542589.html
Chicago News Center: http://www.chicagobreakingnews.com/2009/09/uofc-researcher-dies-after-exposer-to-plague-bacteria.html
Interesting link: http://www.google.com/imgres?imgurl=http://www.precisionliftinc.com/images/ca-gnd-sql.jpg&imgrefurl=http://www.precisionliftinc.com/reconn-plague.shtml&usg=__TNi1T1NKllupDjeDuAimXk850F8=&h=173&w=200&sz=13&hl=en&start=39&sig2=SiDGaPjifgXhHTVmg1TZCg&um=1&itbs=1&tbnid=gQNATwdAAnrFdM:&tbnh=90&tbnw=104&prev=/images%3Fq%3Dsquirrel%2Bplague%26start%3D20%26um%3D1%26hl%3Den%26sa%3DN%26rlz%3D1T4ADBF_enUS273US273%26ndsp%3D20%26tbs%3Disch:1&ei=h3QzTIPrL4GhsgbkjdH3Ag