Monday, March 30, 2009


By Andrew Schneider
March 20, 2009
New government study on possible health hazards from nanoparticles shows much more research is needed and quickly.
Those who care about public health and fear that our government isn’t paying enough attention to the potential hazards spawned by the massive explosion of nano technology have something to cheer. But also something that shows that a lot more research is needed into the new technology — and quickly.
The comfort should come from the knowledge that scientists at the National Institute for Occupational Safety and Health have completed the agency’s second study into the health effects of nanomaterial. The concern lies in the fact the research shows that the material moved easily from inside the lungs of test animals into the pleura, which is the tissue that surrounds the lungs.
The findings are the first to demonstrate that carbon nanotubes aspirated by laboratory mice can actually migrate from the tiny structures in the lung called alveoli, which are critical for gas exchange, through the lungs to the pleura.
“This is important because the pleura is the tissue that can develop a form of cancer, malignant mesothelioma, after asbestos exposure, and multi-walled carbon nanotubes are durable fiber-like particles that share many features with asbestos fibers,” Dr. Ann Hubbs, one of the four scientists on the project told me today.
Research into commercial applications of nanoparticles is being pushed at an intensity never seen with any other technology, but examination of the health and safety implications to workers and the public has lagged significantly, especially in the U.S.
What worries many who have studied the new technology is that because of their infinitesimal size, nanoparticles can and do pass through the body’s traditional barriers and defense mechanisms. They are easily transported through the bloodstream, respiratory and gastrointestinal pathways into all organs, the brain and even individual cells.
Add to this the fact that nanoparticles are often more toxic than traditional products of the same chemical composition that have been used for decades.
There are thousands of unique nanostructures being developed by industry today. The material that the NIOSH team investigated is called multi-walled carbon nanotubes, or MWCNTs. These structures, according to NIOSH, show promise for various applications ranging from creating stronger, more durable building materials to improving cancer therapies.
However, as with other types of engineered nanomaterials, the potential occupational health implications of MWNCTs are not well understood.
In the testing at NIOSH’s Morgantown, W.Va. Laboratory, mice inhaled a small drop of liquid containing the nanotubes in a manner that closely resembles inhalation of the same material suspended in the air, such as an exposure that a worker might encounter.
Other investigators, overseas, have reported inflammation and mesothelioma of the abdominal lining after nanomaterial was injected into the lining of the abdominal cavity.
All of these studies reinforce the need to adopt a rigorous approach to controlling occupational exposures among workers during the production and use of the nanomaterial, NIOSH says.
NIOSH’s pioneering research was presented before the Society of Toxicology this week because of the importance of its findings, but the authors’ stress that the preliminary scientific findings demand that more work be done.
As the only government agency tasked with research on workplace illness and injury, NIOSH is leading the way in health studies on nanotech material.
In addition to Hubbs, who is a veterinary pathologist, the research was conducted by Drs. Vincent Castranova, chief of the Pathology and Physiology Research Branch in the Health Effects Laboratory Division; Hubbs; Dale Porter, a pulmonary toxicologist; and Robert Mercer, a bio-engineer.
For more information, here is a link to a NIOSH document Approaches to Safe Nanotechnology.


A recent article suggests that NIH should perhaps adopt more stringent regulations on the embryonic stem cell communities modeled after UK. In the UK an independent regulatory agcency has oversight covering both private and academic research entities that work on human embryonic stem cell technologies. In the United States, NIH only provides "guidelines" not regulations for academic research. Private companies are not under any jurisdiction or guidelines and essentially are running wild and out of control resulting in public health and safety problems (not to mention octuplets).

Exerpts from the article:

"Officials at the US National Institutes of Health (NIH) will be kept busy for the next four months as they craft new guidelines specifying which embryonic stem (ES) cell research will now qualify for federal funding. But that hasn't stopped the first rumblings of a fight over what the country's regulatory framework might eventually look like."

"Ruth Macklin, a professor of bioethics at Albert Einstein College of Medicine in New York, is among those who support a regulatory agency patterned after the UK's Human Fertilisation and Embryology Authority, in existence since 1990. The HFEA oversees the creation, storage and use of embryos for research, and regulates fertility clinics. Beyond laying out enforceable rules for ES cell science in the United States, she says, a similar scheme would bring order to the largely unregulated in vitro fertilization (IVF) industry."

From New stem cell regulations: By whose authority?by Bryn Nelson, Nature Reports Stem CellsMarch 19th, 2009

Wednesday, March 25, 2009

Stemconn 2009_Where are the cures? Where is the money?

Connecticut residents continue to foot the bill for $100 million investment in human embryonic stem cell research in an economic environment where many cannot afford medical insurance. Tax payers have already paid out approximately $40 million dollars from the $100 million since 2005.

Following Stemconn 2009 conference, no therapeutic products have been produced, nor are they expected in any near future.

Connecticut residents have funded research grants to Yale University, University of Connecticut and Wesleyan University. Funding has been directed toward a variety of basic and therapeutic research targets including Parkinson’s Disease, deafness, Alzheimer’s, regulation of stem cell differentiation, cardiomyocyte and neuron differentiation, intestinal damage, spinal muscular atrophy, vascular regeneration, spinal cord injury, production of blood stem cells, kidney repair, cell cycle and in maintaining core facilities.

The only definable accomplishment since 2005 has been the establishment of two new human embryonic stem cell lines created at the University of Connecticut. These two cell lines provide additional embryonic stem cell cultures up and above several lines already established and approved for federal funding by President Bush.

This accomplishment is far from thrilling to the public. After four years, many ask, “Where are the therapeutic cures that were promised”?

Despite the shortfalls in promises toward therapeutic cures, proponents say that Connecticut’s public funding has produced economic development. Funding in human embryonic stem cell research has provided good paying salaries to biotechnology professionals. It has also attracted twelve experts into Connecticut who desire to work on human embryonic stem cells. In addition, Connecticut researchers claim that they are leading in embryonic stem cell research on the East Coast, ahead of Massachusetts.

President Obama recently has moved to extend federal funding to human embryonic stem cells by lifting restrictions implemented by President Bush. In the current economic downturn where the State of Connecticut and many individuals are struggling financially, Obama’s new directive could influence Connecticut’s legislature to withdraw its mandate forcing residents to continue to fund this research.

Moving Politics out of Science? Huh? Update on Connecticut's Human Embryonic Stem Cell Program

Warren Wollschlager, from the Connecticut Department of Public Health (DPH), speaks at the STEMCELL 2009 conference on Monday, March 23 updating on the fourth year of Connecticut’s $100 million public funding for human embryonic stem cell research. Wollschlager opens with a statement applauding Obama’s support for human embryonic stem cell research by “moving politics out of science”.

Some might find Wollschlager’s comment about “moving politics out of science” a bit ironic.

Both Wollschlager and DPH Commissioner J. Robert Galvin, who chairs the Connecticut’s Stem Cell Advisory Committee, are political appointments involved in Connecticut’s stem cell program. Politics are intimately tied to Connecticut’s stem cell program. The DPH’s political mandate is to ensure economic success in Connecticut’s embryonic stem cell program.

That directive creates conflicts of interest for this agency to uphold and safeguard public health and safety. In fact, the office of Connecticut Department of Public Health has shown a lack of safety regulations on laboratories performing dangerous embryonic stem cell technologies even when illness has been reported. This conflict of interest poses threats to worker safety and public health and safety in Connecticut.

That’s politics for you.

Wollschlager and other advocates for stem cell research often use rhetorical phrases like “moving politics out of science” to sway public opinion into their camp. Here they want to massage the public into thinking that embryonic stem cell research has been delayed because of politics instead of the ethical dilemma it encases by using and destroying human embryos for research.

No, Mr. Wollschlager. It may be impossible to take politics out of stem cell research. But perhaps the problem lies in confusing the term “politics” with “ethics”.

Are we actually moving “politics out of science” or is it rather moving “ethics out of science”?

Tuesday, March 24, 2009

Jonathan Leo...HERO

Dr. Jonathan Leo a physician and professor of neuro-anatomy (Boy, he looks like he is only 16 years old!) should be seen as a hero within the medical community. With all the political pressures and backlashing within the medical profession today, this one physician had the courage to report conflict of interest in a study that was published in JAMA.
We need more honest and courageous physicians to stand up for what is right. But we also need laws to protect them for doing so. Many physicians get blacklisted or fired for speaking or doing what is right.
Cheers for Jonathan Leo!
For more see WSJ blog.

Monday, March 23, 2009

Stem Cells and Count Dracula

Today it was announced that scientists in Britain plan to invest to become the first to develop an unlimited amount of synthetic human blood for emergency use from spare human IVF embryos .

This of course brings up ethical discussions, but how about the scientific problems?

And what is this "synthetic" stuff about? Why are they called "synthetic" blood cells when they are made from embryonic stem cells of a human embryo? Are they going to clone animal parts into these “human embryonic stem cells-turned blood cells” making them synthetic chimeras? Or perhaps use nano-synthetic elements? Or maybe they will obtain these embryonic derived blood cells from eggs of the brood of Count Dracula making them "synthetic"? Sounds like the making of a great Sci Fi movie.

Nevertheless, I hope I am not the poor soul who has the emergency and needs to be pumped full of synthetic embryonic human blood cells as I lay unconscious on a gurney. There are too many dangers associated with embryonic stem cell technologies that are being kept from public.

Sunday, March 22, 2009

Stem Cell Clinical Trials

Using the world's largest registry for clinical trials called Clinical which is maintained by the National Institute of Health, "The Stem Cell" blogger, Christopher Scott, reports a substantial increase in stem cell clinical trials since 2004. A total of 2319 stem cell related clinical trials (a 227% increase) were conducted last year. These stem cell trials tested treatments for a variety of diseases such as cancer, heart disease, diabetes, and parkinsons. No trials using human embryonic stem cells were performed last year. But 334 gene therapy trials using stem cells were conducted.

It is apparent that stem cell research has been actively pursured, despite President Bush's restraints on human embryonic stem cell research. The first human embryonic stem cell clinical trial will be conducted this year.

Wednesday, March 11, 2009


The excessive use of so-called "confidential" business information is being used today to avoid transparency and legal responsibility in both the chemical and biotech industries. Pharmaceutical and chemical manufactures can claim “trade secret” without any justification and thereby automatically deny the government and the public access to public health and safety information pertaining to dangerous products even after people fall ill from exposures. Most disturbingly, this tactic has even been used to deny biotech workers rights to exposure records for healthcare.

Our current laws make it difficult to break this unethical chain of abuse. It is expensive and time-consuming to challenge these fraudulent companies in court.

Nevertheless we need to get tough with these companies who pollute and harm the public, but feign “trade secret”. Heavy and substantial fines should be levied on all who place unwarranted trade secret claims on dangerous products in an effort to hide pertinent information and avoid responsibility. The fines should be so substantial that it will send a distinct message throughout this industry: “No MORE FRAUD!”

See this interesting article about EPA’s problem with these types of abuses from pharmaceutical and chemical manufacturers.

Scientific Misconduct: Fabricating Drug Studies

(Excerpts from A New Low in Drug Research: 21 Fabricated Studies. For entire story see link to
"A prominent Massachusetts anesthesiologist (Scott S. Reuben) allegedly fabricated 21 medical studies involving major drugs."
"Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica and Celebrex and Wyeth’s antidepressant Effexor XR."
"Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines."
"...his attorney said Reuben “deeply regrets that this happened.” The attorney also referred to “extenuating circumstances,” but didn’t elaborate on what they were."


Now that President Obama has mandated tax payers to fund human embryonic stem cell research, he has concomitantly ordered the NIH to establish guidelines for responsible and safe research within human embryonic stem cell research. The NIH is mandated to post these guidelines for public review within 120 days. But President Obama’s order for NIH “guidelines” leaves many of us considerably concerned. “Guidelines” lack essential and enforceable edicts and will not protect public health and safety or biotech worker’s rights.

Unfortunately, the NIH has not established a good track record when it comes to promoting and protecting public health and safety through such guidelines.
In fact the NIH guidelines for “recombinant DNA research” have had several serious problems with protecting public health and safety, including worker’s right. Most disturbingly, the NIH has been involved in denying biotech workers the right to obtain biological exposure records by supporting the position that “trade secrets supersede a worker’s right to this information”. This has left scientists little rights to full disclosure to the characteristics of the biological agents to which they were exposed and which, consequently, inhibits their ability to seek directed medical care. As a result, injured biotech workers have been left ill with no possible medical avenue, while the scientific community remains legally free of any fault or responsibility and the public remains ignorant of the dangers.

NIH guidelines are just that…guidelines and not laws.
Guidelines are not laws. Guidelines are difficult to enforce and will provide legal loop holes in attempting to direct safe and responsible use of human embryonic stem cell research.
1. Guidelines adhere to “self policing policies” with no effective oversight, no mandated transparency and leave little incentive for the violators to report violations.
2. Guidelines are written to protect vested interest within the scientific community and not to prioritize the protection of worker’s health or safety rights or public health and safety.
3. Guidelines provide no whistleblower protections for workers who raise public health and safety issues and who subsequently are shown retaliation.

NIH guidelines only apply to federally funded labs.
The public should be aware that NIH guidelines will only apply to federally funded research laboratories, and not private commercial or pharmaceutical labs employing dangerous embryonic stem cell technologies. Private industry, engaging in human embryonic stem cell research, is wildly unregulated. Many of these labs develop genetically-engineered human infectious agents to make embryonic stem cells “sick” for drug discovery purposes. Nevertheless, these companies work with no legal and enforceable regulations in an environment which obviously poses serious public health and safety concerns.

Laws Needed
Although, President Obama has mandated the NIH to provide “guidelines” for federally funded human embryonic stem cell research, the past has shown that guidelines do not work to protect public health and safety or to ensure rights to biotech workers. We need new laws that are enforceable, that promote transparency and are current to modern day biotechnology. These laws should ensure biotech worker’s rights to a safe workplace and to biological exposure records. These new laws should also provide jurisdiction within both federally-funded and private laboratories throughout the United States where dangerous human embryonic stem cell technologies are being developed. It is especially essential to enact strong whistleblower laws to protect scientists and physicians. This is key to effective regulation in this industry. It is a fact that without free speech and whistleblower protection, public health and safety cannot be protected under any circumstances.

A watchful eye should be cast on the NIH when they propose guidelines for human embryonic stem cell research within 120 days and call for public comment. The public should understand that these “guidelines” are helpful to establish baseline practices within the scientific community. But guidelines are not laws. NIH guidelines do not have the legal power or jurisdiction to provide adequate transparency or protection for public health and safety against the dangers of embryonic stem cell research. We desperately need effective laws and not just NIH “guidelines to regulate human embryonic stem cell technologies. The public has every right to demand that effective laws and regulations be placed upon the embryonic stem cell community immediately since NIH guidelines currently are not and assuredly will not be adequate in the future to protect both worker and public health and safety.

For more on stem cell guidelines see link.