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”?

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.

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.

Stem Cell Clinical Trials

Using the world's largest registry for clinical trials called Clinical Trials.gov 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.

TRADE SECRET ABUSE

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 WSJ.com)
"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."

I CAN'T WAIT TO FIND OUT WHAT EXTENUATING CIRCUMSTANCES ARE INVOLVED WITH THIS CASE OF SCIENTFIC MISCONDUCT. Should we dare guess$$$$$?

NIH GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH WILL NOT PROTECT PUBLIC HEALTH AND SAFETY

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.