Saturday, April 25, 2009
This Tuesday, April 28th, 2009, Becky McClain, biotechnologist, will honor Dr. Jeannette Adu-Bobie at the San Francisco Worker's Memorial Day press conference at 3pm at 455 Mission Bay Boulevard South at 3rd St., San Francisco. Dr. Adu-Bobie’s struggle illustrates the difficulties injured biotech workers face.
In 2005 Dr. Adu-Bobie, a British scientist, who specializes in meningococcal bacteria research, lost her legs, left arm and right digits after contracting a meningococcal infection while working in a New Zealand vaccine lab. The vaccine lab strain was identical to the strain that had infected Dr. Adu-Bobie. Unbelievably, officials still denied her injuries originated from her workplace. It took three years of legal struggle, before experts finally admitted that her injury was caused by her work. In the end she only received $117,000 for damages. Her story highlights the realities and struggles that injured biotech workers face. She has been courageous enough to break the silence about dangerous work conditions in biotech laboratories. Dr. Adu-Bobie questioned safety procedures when she saw Neisseria meningitidis being plated out on an open bench and subsequently, but mysteriously, came down with the life threatening and disabling infection. We honor Dr. Adu-Bobie’s fortitude and courage.
Press release: http://www.workersmemorialday.org/documents/WMD%2009-SF%20flyer.pdf
See VIDEO: http://tvnz.co.nz/view/video_popup_windows_skin/1983298
Friday, April 24, 2009
Swine flu viruses in U.S. and Mexico match, CDC says
Posted: 04:15 PM ET
(CNN) — U.S. health officials expressed concern Friday that a swine flu virus that has infected eight people in the United States matches samples of a virus that has killed at least 60 people in Mexico.
U.S. health experts also are concerned because nearly 1,000 people have fallen ill in Mexico City in a short period of time.
“This situation has been developing quickly,” said acting CDC director Richard Besser. “This is something we are worried about.”
Of the 14 Mexican samples tested by the Centers for Disease Control and Prevention, seven were identical to the swine flu virus found in Texas and southern California, Besser said at a news conference.
The eighth U.S. case was reported Friday.
All of the eight U.S. patients have recovered, Besser said.
Post taken from: http://cnnwire.blogs.cnn.com/2009/04/24/swine-flu-viruses-in-us-and-mexico-match-cdc-says/
Recombinant DNA laboratories all over the country which are especially concentrated in CA are developing genetically engineered viruses and synthetic genetic technologies without regulations or reporting requirements. Release of these agents no doubt could cause new emerging disease. Maybe the CDC should do an epidemiology study and see where all these new emerging diseases are clustering around. They might be surprised to find them popping up around biotechnology centers.
"On April 17, 2009, CDC determined that two cases of febrile respiratory illness occurring in children who resided in adjacent counties in southern California were caused by infection with a swine influenza A (H1N1) virusThe viruses from the two cases are closely related genetically, resistant to amantadine and rimantadine, and contain a unique combination of gene segments that previously has not been reported among swine or human influenza viruses in the United States or elsewhere. Neither child had contact with pigs; the source of the infection is unknown. Investigations to identify the source of infection and to determine whether additional persons have been ill from infection with similar swine influenza viruses are ongoing. This report briefly describes the two cases and the investigations currently under way. Although this is not a new subtype of influenza A in humans, concern exists that this new strain of swine influenza A (H1N1) is substantially different from human influenza A (H1N1) viruses, that a large proportion of the population might be susceptible to infection, and that the seasonal influenza vaccine H1N1 strain might not provide protection. The lack of known exposure to pigs in the two cases increases the possibility that human-to-human transmission of this new influenza virus has occurred."
Tuesday, April 21, 2009
Worker deaths from toxic exposures, other work illnesses are conservatively estimated by NIOSH and other researchers at 50,00 to 60,000 deaths each year, or ten times the number of fatalities from work injuries. 1, 2, 3. It is a disaster of monumental proportions that goes largely unrecorded. The United States has no comprehensive occupational health data collection system.
As we have lagged behind other nations in our lack of a national comprehensive medical and statistical database on occupational illnesses, occupational injuries; we have lagged behind in the research into the causes and consequences of occupational illnesses that would lead to improved diagnosis, treatment, prognosis, and ultimately prevention, of occupational toxic exposures and resultant diseases.
While the United States has set permissible exposure limits on less than 500 of the hundreds of thousands of chemicals in use in workplaces throughout our country, the EU regulates 30,000 chemicals utilized in their workplaces, and many that we allow here have been banned for years in the EU.4 Even the small number of chemicals, upon which exposure limits have been set in the US, are grossly out of date based on more recent scientific data.
It is a major and costly health issue – costly in lives, and costly in dollars. The economic burden for occupational illness, injury and death in our country is an estimated $170 billion annually. It is an economic burden that falls mainly on families (44%) and on taxpayers (18%); with only 27%, on average, being paid by workers’ compensation. 5.
There has been very little general public awareness of this system that maims and kills with impunity. The time is long overdue to re-evaluate a structure that evolved over one hundred years ago; and which clearly doesn't meet the needs of seriously injured, ill, or toxic chemical-exposed workers, or the families of workers who died from their work – a system that has fostered devastating and lasting damage to families, to communities, to our environment.
2 U.S. House of Representatives. Hidden Tragedy: Underreporting of Workplace Injuries and Illnesses. A Majority Staff Report by the Committee on Education and Labor. Honorable George Miller, Chairman, June 2008.
3 Steenland, Kyle; Burnett, Carol; Lalich, Nina; et al.Dying for Work: The Magnitude of US Mortality From Selected Causes of Death Associated With Occupation, American Journal of Industrial Medicine, Vol 43, pp 461-482, 2003.
4 Regulation EC 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), http://eur-lex.europa.eu/.
5 op. cit. Leigh, et al, 2000.
6 LaDou, J., M.D. Occupational and Environmental Medicine in the United State: A Proposal to Abolish Workers’ Compensation and Reestablish the Public Health Model,International Journal of Occupational and Environmental Medicine in the United States. 2006; 12 (2) 154-168; and US Department of Health and Human Services, National Center for Health Statistics, Centers for Disease Control and Prevention, National Vital Statistics System, National Vital Statistics Reports, Vol 53, Number 5. Deaths: Final Data for 2002, Table 10 and Worktable I, pp. 1585, 1634, 1662, 1703, 2220-2224, athttp://cdc.gov/hchs/data/dvs/mortfinal2002_workipt2.pdf
Monday, April 20, 2009
COMMENTS: The NIH welcomes public comment on the draft Guidelines. Comments must be submitted within 30 days of publication of the Guidelines in the Federal Register. The Guidelines are expected to be published in the Federal Register by April 24th. Comments may be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997. At the time of publication in the Federal Register, the NIH will make available a URL where comments may be submitted electronically. In submitting comments, please note that comments will be made publicly available, including any personally identifiable or confidential business information they contain.
NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR HUMAN STEM CELL RESEARCH
SCOPE OF GUIDELINES
These Guidelines describe the circumstances under which human embryonic stem cells are eligible for use in extramural NIH-funded research, and they also include a section on uses of human embryonic stem cells or human induced pluripotent stem cells that are ineligible for NIH funding.
For the purpose of these Guidelines, “human embryonic stem cells” are cells that are derived from human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos.
GUIDELINES FOR ELIGIBILITY OF HUMAN EMBRYONIC STEM CELLS FOR USE IN RESEARCH
The Executive Order: Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, states that the Secretary of the Department of Health and Human Services (DHHS), through the Director of the NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.
Eligibility of Human Embryonic Stem Cells Derived from Human Embryos: Human embryonic stem cells may be used in research using NIH funds, if the cells were derived from human embryos that were created for reproductive purposes, were no longer needed for this purpose, were donated for research purposes, and for which documentation for all of the following can be assured:
All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s).
No inducements were offered for the donation.
A policy was in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s).
There was a clear separation between the prospective donor(s)'s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes.
At the time of donation, consent for that donation was obtained from the individual(s) who had sought reproductive services. That is, even if potential donor(s) had given prior indication of their intent to donate to research any embryos that remained after reproductive treatment, consent for the donation should have been given at the time of the donation. Donor(s) were informed that they retained the right to withdraw consent until the embryos were actually used for research.
Decisions related to the creation of human embryos for reproductive purposes were made free from the influence of researchers proposing to derive or utilize human embryonic stem cells in research. Whenever it was practicable, the attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize human embryonic stem cells should not have been the same person.
Written informed consent was obtained from individual(s) who sought reproductive services and who elected to donate human embryos for research purposes. The following information, which is pertinent to making the decision of whether or not to donate human embryos for research purposes, was in the written consent form for donation and discussed with potential donor(s) in the informed consent process:
A statement that donation of the embryos for research was voluntary;
A statement that donor(s) understood alternative options pertaining to use of the embryos;
A statement that the embryos would be used to derive human embryonic stem cells for research;
Information about what would happen to the embryos in the derivation of human embryonic stem cells for research;
A statement that human embryonic stem cells derived from the embryos might be maintained for many years;
A statement that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the stem cells;
A statement that the research was not intended to provide direct medical benefit to the donor(s);
A statement as to whether or not information that could identify the donor(s) would be retained prior to the derivation or the use of the human embryonic stem cells (relevant guidance from the DHHS Office for Human Research Protections (OHRP) should be followed, as applicable; see OHRP's Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles (37.8 KB PDF; get Adobe Reader) and Guidance on Research Involving Coded Private Information or Biological Specimens, or successor guidances); and
A statement that the results of research using the human embryonic stem cells may have commercial potential, and a statement that the donor(s) would not receive financial or any other benefits from any such commercial development.
Prior to the use of NIH funds: Funding recipients must ensure that: (1) the human embryonic stem cells were derived consistent with sections II.A and B of these Guidelines; and (2) the grantee institution maintains appropriate documentation demonstrating such consistency in accordance with 45 C.F.R. Part 74.53, which also details rights of access by NIH. The responsible grantee institutional official must provide assurances with respect to (1) and (2) when endorsing applications and progress reports submitted to NIH for projects that utilize these cells.
RESEARCH USING HUMAN EMBRYONIC STEM CELLS AND/OR HUMAN INDUCED PLURIPOTENT STEM CELLS THAT, ALTHOUGH THE CELLS MAY COME FROM ALLOWABLE SOURCES, IS NEVERTHELESS INELIGIBLE FOR NIH FUNDING
This section governs research using human embryonic stem cells and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. There are some uses of these cells that, although they may come from allowable sources, are nevertheless ineligible for NIH funding, as follows:
Research in which human embryonic stem cells (even if derived according to these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
Research involving the breeding of animals where the introduction of human embryonic stem cells (even if derived according to these Guidelines) or human induced pluripotent stem cells may have contributed to the germ line.
OTHER NON-ALLOWABLE RESEARCH
NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.
NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.
Raynard Kington, M.D., Ph.D.Acting Director, NIH
Sunday, April 19, 2009
Congressional Research Service Summary
The following summary was written by the Congressional Research Service, a well-respected nonpartisan arm of the Library of Congress. GovTrack did not write and has no control over these summaries.
Patients First Act of 2009 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells that may result in improved understanding of, or treatments for, diseases and other adverse health conditions, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not such pluripotent stem cells have an embryonic source), provided that such techniques will not involve: (1) the creation of a human embryo for research purposes; (2) the destruction or discarding of, or risk of injury to, a living human embryo; or (3) the use of any stem cell the derivation or provision of which would be inconsistent with this Act.
Requires the Secretary to issue guidelines implementing this Act to ensure that any research (including any clinical trial) supported under this Act: (1) is clearly consistent with the standards established in this Act, if conducted using human cells; (2) is prioritized in terms of potential for near-term clinical benefit in human patients; and (3) may take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research.
Requires the Secretary to: (1) report on peer reviewed stem cell research proposals that were not funded; and (2) study and submit recommendations to Congress on any structural changes to the C.W. Bill Young Cell Transplantation Program that would help to expand access to new and future stem cell therapeutic products.
Wednesday, April 15, 2009
An institutional review board that approved a fake clinical trial brought to it by a government sting operation won’t have the chance to approve any real FDA-regulated studies any time soon.
Coast IRB was snagged by an undercover investigation in which congressional staff and the Government Accountability Office created a fake medical study of a fake product to see whether for-profit review boards adequately supervise medical trials. IRBs must sign off on clinical trials before they can go ahead; a major charge they have is to look out for the well-being of trial subjects.
Coast “approved our bogus research protocol for human subjects testing after only minor edits to our submission materials, even though we were a bogus company with falsified credentials and an unproven medical device,” the GAO wrote in a report. (GAO didn’t name Coast directly in the report, but did so in congressional testimony.)
The FDA said today that Coast has agreed, until further notice, to stop reviewing new FDA-regulated studies and will direct researchers involved with ongoing FDA-regulated studies it previously approved to halt enrollment of new subjects. Some 300 studies involving some 3,000 researchers may be affected, the agency said. The agency added that the already-approved trials would be allowed to continue and said in a Q&A that its action was “precautionary.”
In a warning letter to the company, the FDA said Coast’s violations included failing to determine whether risks to subjects would be minimized and to show its ability to determine whether the research was acceptable under legal and professional standards.
Update: In a written statement, Coast CEO Daniel Dueber said the company is cooperating with the FDA and is making “sweeping” changes “designed to exceed the level of protection required by existing law.” Changes in the works include putting a new board in place, establishing new standard operating procedures and doing frequent internal audits.
“We are revamping every aspect of the company,” Dueber said. “Within the next 30 days this company will be completely different, operated by different people, relying on different standard operating procedures, even having a different name.”
See Coast news releases on the matter.
Tuesday, April 14, 2009
Poor Jack, our hero. This is serious stuff.
Is the biowar agent scenerio in 24 believable? Could this be a genetically engineered virus carrying a prion?
Genetic sequences encoding prions, no doubt could be cloned into a virus particle...but will its expression produce a functional prion? If so, then the biowar scenerio in 24 may not be that too far-fetched.
Through genetic engineering we can now weaponize virus particles to our liking; we can insert new genes into them to produce toxins. We can also design viruses to infect where naturally they would not.
For example, in research laboratories we can and have genetically designed the HIV virus to extend its tropism. That is, where the HIV virus used to infect only via a needle stick, or blood to blood contact, scientists have now engineer it to infect through inhalation, ingestion or mucosal contact.
So in Jack’s case, here is how it might work. The virus, a non-replicating form which is not contagious but engineered to have broad tropism of infection, infects the lungs, mouth and eyes of our hero Jack Bauer through gaseous exposure. Subsequently, through this initial exposure the lungs, optic nerve and trigeminal nerve become infected. The virus continues to travel up his nerves and into his central nervous system. The virus then integrates into the DNA of the nervous system cells. It now is ready to rock and roll.
The virus, now hiding in the nervous system, starts it production machinery, expressing and pumping out loads of the prion protein. The prion protein then causes normal proteins to fold inappropriately, beginning a chain reacation of neurological insult and neuron death. And poor Jack Bauer our hero begins to shake and loose memory and becomes a MAD HATTER. ARRRRRRHHHHHHHHHHH....
Poor Jack. Someone save him. Will it be adult embryonic stem cells through his daughter's bone marrow? Dear me…More stem cell hype.
I can’t wait to find out how he gets out of this one.
Monday, April 13, 2009
From the WSJ blog: Researcher Faked Data in Sleep Apnea Study
More news on the research-fabrication front. Robert Fogel, a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients, the Office of Research Integrity at HHS said.
The journal Sleep has retracted the 2003 study, titled “Anatomic and physiologic predictors of apnea severity in morbidly obese subjects.” The research-integrity office said Fogel’s changed or falsified nearly half of the sleep data “so that those data would better conform to his hypothesis.” He also fabricated about 20% of anatomic data that supposedly came from CT scans, the office said, based on information that Fogel volunteered.
Fogel, who worked at Brigham and Women’s Hospital at the time but later moved on to work at Merck, told a former supervisor in 2006 that he had falsified the data, the Scientist reports.
“What I did was obviously horrendously wrong,” Fogel told the Scientist, adding this was the only paper on which he’d done this.
“I moved numbers around to make the data look like there was something there,” he said. “I never really thought through the consequences, and once I did this I got myself into a loop that I found I couldn’t get out of.”
Fogel’s fabrications don’t appear as widespread as those of a Massachusetts doctor who allegedly faked data in 21 published studies. Harvard reviewed about 30 Fogel studies and found nothing else amiss, the Scientist said. A spokesman for Brigham and Women’s told the Harvard Crimson that the hospital supports the investigation’s findings.
Hat Tip: White Coat Notes
Check the comments out @ http://blogs.wsj.com/health/2009/04/10/researcher-falsified-data-in-sleep-study/tab/comments/
Saturday, April 11, 2009
But remember, I had a gun to my head. If I had a free choice, I most likely would turn, high tail it quickly toward the nearest exit, choosing neither option, unless a sound clinical trial had been performed and I had access to the results of such trial.
But back to the gun at my head….
Adult stem cell therapy is generally considered to be safer than embryonic stem cell therapy since it does not have the potential to create a teratoma, infamous for embryonic stem cell therapy gone wild, gone wrong. Teratomas are the ying of the embryonic stem cell potential, the yang being pleuropotency, the potential to form any cell in the body.
But this decreased risk using the adult stem cell does not necessarily indicate that adult stem cell therapy is safe, free of dangers. Even if the adult stem cells are harvested from one’s own body, serious problems and dangers can present if those cells are not handled safely, appropriately controlled or have undergone any chemical or genetic manipulated while in culture.
In vitro (i.e. in culture) manipulation of adult stem cells can lead to dangerous and unpredictable changes within the adult stem cell or lead to a contamination that could cause great harm to a patient, even death. Adult stem cell therapies should be regulated with GMP standards. Scientific technicians should be certified and trained to do this work. Well, at least that is what I would demand.
The other danger with using any stem cell treatment (that being adult or embryonic) is what I call “positional effects”. That is, where the stem cell is placed back in the body of the patient could negatively impact safety of the patient. Try shooting a syringe full of adult stem cell osteoblasts inside a human brain and let’s see how safe that will be. Not on me you won't.
Adult stem cell therapies can be used to potentially treat a variety of diseases in different ways in different forms. To ensure patient safety and enhance scientific discovery, much research is still needed to understand the science behind adult stem cell therapy and how, what, where and why it will be used. This requires formal clinical trials. Period.
A sudden pool of pro-adult stem cell proponents (most likely linked to the industry of “physicians gone biotech” and their ties to desperate patient advocacy groups) have entered the blogosphere recently in numerous numbers, vocally advocating with resounding stomping of feet, that adult stem cells are proven safe and should not be regulated. This is another ploy by the scientific community to mislead the public in order to avoid any type of regulation within the biological research sciences. It is getting to be absurd and truly is dangerous. It exploits the public, especially those with serious debilitating illness, leading many to sign up for dangerous unregulated clinical trials. It’s bad science.
The FDA is on the prowl and not happy about this. I don’t blame them. The FDA is not perfect. But this time they are right in their argument. Adult stem cell therapy should be regulated. It has not been proven safe.
Just because adult stem cell therapies are offered in other parts of the world doesn’t prove that they are safe or effective. Adult stem cell therapy offers a safer and better ethical alternative than embryonic stem cell therapy. But adult stem cell therapies are used in many different ways, requiring oversight to ensure patient safety and do good science.
Watchdogonscience is not all about controversial scientific issues. Watchdogonscience also keeps an eye open for interesting natural species to share the wonders of this amazing world.
Here is one that is incredible. Check this big ol’ snake out. It is touted to be the largest dead snake ever found.
Thursday, April 9, 2009
I doubt it. The scientific community wants full broad range to research on human embryos for many reasons that if fully disclosed, would make the public shudder.
But this iPS stuff is trouble, even for Dr. Evil.
You see, the iPS discovery has put the human embryonic researchers in a tizzy…another ethical tizzy when trying to convince the public about the justification to continue to research and destroy human embryos.
Scientific propaganda machine start your engines….AND THEY’RE OFF!
The new propaganda slogan is out and running…stating that human embryonic stem cells are still needed because they serve as the “golden standard”.
Golden standard for what?
Excuse me. Once the embryonic stem cell is placed in a petri dish apart from its 50 to 100 other embryo brother or sister cells, it no longer is a golden standard for anything.
It is a new in vitro entity, alone, trying to figure out what to do and what to become… in a new unfamiliar environment with no motherly direction. It is at the mercy of the scientist’s discretion and his artificial treatments…chemical, genetic, hot, cold. Most of the time, at this point, the human embryonic stem cell is just struggling to stay alive ....floating or attached to a petri dish.
The embryonic stem cell removed from the embryo… ain’t anybody's golden standard.
Any scientist with any brains and an ounce of integrity will admit that the golden standard for a stem cell clinical therapy will be the target adult differentiated cell, not the embryonic stem cell. For example, if you are going to cure a heart ailment with stem cell technology, the “golden standard” is the adult cardiocyte, not the undifferentiated embryonic stem cell.
The scientific propaganda machine continues to run with full engines in gear. They will use every false- justification imagined in order to convince the public that scientists must continue to work on human embryos despite good alternative technologies such as iPS and adult stem cells.
The scientific propaganda machine convinced the public to use human embryos to find all those promised miracle cures that have not been delivered. They will continue to find some poor reason to blind the public again to continue their sly endeavors to manipulate and manhandle human dignity…oh… I meant, the human embryo...all in the name of science.
For example, using iPS technology, the skin cell can be reprogrammed using genetic engineering techniques to express four genes that subsequently change the adult cell (i.e, skin cell) into a embryonic-like- stem cell.
With these changes the iPS cell can now theoretically develop into any cell type in the body (a term called pluripotency)...just as embryonic stem cells are said to be. Since pluripotency is the reason why embryonic stem cells are touted to hold much therapeutic promise, the iPS cell holds comparable therapeutic promise.
Like adult stem cells, the iPS method provides an alternative scientific method to find cell-based therapeutic cures without the destruction of embryos. This has been a boon for those scientists who believe it unethical to use human embryos in research.
The first human iPS cell created in 2007 was a huge scientific breakthrough. Here is a link to a another recent breakthrough making iPS cells potentially safer for therapeutic targets. Breakthrough makes lab-produced stem cells safer for humans, Science Centric March 1, 2009
Tuesday, April 7, 2009
Out of court settlement in the case that inspired 'The Constant Gardener'
By Daniel Howden, Africa Correspondent
Monday, 6 April 2009
A divorce case was all that passed for excitement at Richard P Altschuler's "kinda small" lawyer's office in West Haven, Connecticut, when the phone rang nine years ago. On the other end of the line, a world away in the heat of Nigeria, was Etigwe Uwo, a young lawyer with "an incredible story about Pfizer". The Lagos attorney was going to take on the largest pharmaceutical company in the world in an unprecedented class action pitting African parents against an American corporate giant. And he needed help.
Mr Etigwe had chosen Mr Altschuler because, back in 1979, the Connecticut lawyer had successfully defended a friend of the Nigerian. The unlikely pair were about to embark on a marathon journey into the world of "big pharma". Nine years on and their efforts have finally been rewarded with a reported $75m (£50m) settlement, the terms of which are likely to be released this week.
If it sounds like the script of a Hollywood blockbuster that's because it was this story that prompted John Le Carre to write The Constant Gardener, according to Mr Altschuler.
In real life it was to Nigeria, not Kenya, that Pfizer turned. In 1996, the company needed a human trial for what it hoped would be a pharmaceutical "blockbuster", a broad spectrum antibiotic that could be taken in tablet form. The US-based company sent a team of its doctors into the Nigerian slum city of Kano in the midst of an appaling meningitis epidemic to perform what it calls a "humanitarian mission". However the accusers claim it was an unlicensed medical trial on critically-ill children.
A team of Pfizer doctors reached the Nigerian camp just as the outbreak, which killed at least 11,000 people, was peaking. They set themselves up within metres of a medical station run by the aid group Médecins Sans Frontières, which was dispensing proven treatments to ease the epidemic.
From the crowd that had gathered at the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were treated with a proven antibiotic from a rival company.
Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage. But with meningitis, cholera and measles still raging and crowds still queueing at the fence of the camp, the Pfizer team packed up after two weeks and left.
That would probably have been an end to the story if it weren't for Pfizer employee, Juan Walterspiel. About 18 months after the medical trial he wrote a letter to the then chief executive of the company, William Steere, saying that the trial had "violated ethical rules". Mr Walterspiel was fired a day later for reasons "unrelated" to the letter, insists Pfizer.
The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial. But did the parents know that they were offering their children up for an experimental medical trial?
"No," Nigerian parent Malam Musa Zango said. He claims his son Sumaila, who was then 12 years old, was left deaf and mute after taking part in the trial. But Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.
At stake at one point last year was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. "There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano," Mr Etigwe said. "The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer." Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.
It appears that Pfizer has finally ended the public relations nightmare with Friday's settlement. But the Trovan battle may not be over yet.
At the end of January 2009, a New York appeal court ruled Mr Etigwe and Mr Altschuler's case could be heard in the US. The Connecticut attorney says it could still go ahead. "Our case is firmly embedded in the US ... so a Nigerian settlement does not foreclose our case. But this is very good news. I'm glad we remained the constant gardener and could see this come to fruition."
Friday, April 3, 2009
Although some scientist say that the creation of chimeric animals can aid in medical breakthroughs, this research carries both ethical and safety risks. But strangely, this controversial research is being kept under the radar screen and isn’t getting any media attention.
Here is one fun and crazy spooky spoof, however, that takes the idea of chimeric animals to new heights! Check out the youtube video on Qualcomm. http://www.hollywoodbioethics.com/2009/04/02/a-day-late/
(FYI: the posted picture of the chimeric pig-human isn’t real…its ART!. Didn’t want you to freak.)
The safety and health of America’s working men and women should be a top priority of any administration. But, a new report from the Department of Labor’s Office of Inspector General (OIG) released today reveals that the Bush Administration’s Occupational Safety and Health Administration systematically failed to enforce the law against employers who put workers in serious danger. The OIG investigation of OSHA practices under its Enhanced Enforcement Program (EEP) – a program calling for stepped up enforcement against serious violators – found that in 97% of studied enforcement cases, OSHA’s follow-up was deficient or lacking. This failure may well have cost workers their lives. The OIG found that at worksites of 45 employers where OSHA oversight was deficient, 58 workers subsequently were killed by job hazards. The Enhanced Enforcement Program was designed to target employers who were indifferent to their workers’ safety, but OSHA’s leadership under President Bush was apparently indifferent to making the program work. There is simply no excuse for OSHA’s failure to properly designate and inspect dangerous worksites, conduct follow-up inspections and enforce enhanced settlement provisions. This report is an indictment of the Bush Administration’s unwillingness to protect and safeguard America’s working men and women. It also demonstrates that many employers, including some of the country’s biggest companies, are failing to meet their responsibility to protect workers. Fortunately, America has a new Secretary of Labor who is committed to putting the needs of working families at the forefront of her agenda. With workplace fatalities averaging over 5,680 annually, the new administration must not hesitate to robustly execute and enforce the law. This report underscores the need for strong leadership and a renewed commitment to protecting workers’ safety and health at OSHA. The Department of Labor’s report can be found at: http://www.oig.dol.gov/public/reports/oa/2009/02-09-203-10-105.pdf.
Thursday, April 2, 2009
In the past two months, the new US president directed the federal government to develop some oversight of human embryonic stem cell research, and two scandals in the fertility industry (with a potential third one brewing) led to demands that the $3 billion baby business be brought under responsible regulation.Now, a sting-style investigation by Congress into the protection of human research subjects may lead to new legislation. The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee held a hearing last week, focusing on a two-pronged undercover operation conducted by Congresses' Government Accountability Office.On one front, the GAO created a fictitious company, product, and proposed clinical trial, based on a rejected proposal from a few years ago. It was was then submitted to three private Institutional Review Boards (IRBs) for approval. Although two of the IRBs similarly rejected the vague proposal, Coast IRB approved the project unanimously. Coast seems to epitomize the shortcomings of private companies which approve research on humans. It advertises its fast 48 hour turnaround time on submissions, and even publishes a coupon for a free review, offering prospective customers to "take us for a free test drive" and to "coast through your next study." In the last five years, Coast approved all 356 submitted protocols. And in the case of the GAO's faked application, Coast didn't even examine the submitted data.
Rep. Henry Waxman (D-CA), said in his opening statement [PDF]:
This is actually a coupon for experimental testing on human beings. The company virtually guarantees approval, and it offers the first review for free. Can you imagine going to the hospital for major invasive surgery and having your doctor ask whether he can use a device approved after cashing in a coupon?
On the other front, the GAO took on government oversight of private IRBs. It created a clearly bogus IRB, and sought authorization from the Department of Health and Human Services. Not only did HHS give its seal of approval, but the fake IRB began to receive inquiries from researchers, and even received a full protocol for its approval.
For more on private IRBs, see "Big Pharma's Shameful Secret," [PDF] Bloomberg Markets (Dec. 2005).
Wednesday, April 1, 2009
Below is an example of Scientific Propaganda Tactic #1:
ONLY PROVIDING PART OF THE ANSWER IN ORDER TO MISREPRESENT THE TRUTH
The Business Journal recently published an article asking Robyn Shapiro the following question concerning regulations imposed upon human embryonic stem cell research performed in private industry:
Q. For embryonic stem cell research going on in the private sector, are there rules or guidelines those researchers must follow?
Robyn Shapiro's answer: “The FDA (Food and Drug Administration) regulates this kind of research. It’s ironic, but at the end of January, the FDA gave approval for the first clinical trial use of embryonic stem cells in spinal cord conditions, so 10 patients are in that trial. I think (the FDA) spent a year looking at that, but that is, of course, privately funded research.”
(From Ms. Shapiro’s answer one gets the impression that private industry is stringently regulated. Wrong!)
The more complete answer should have been:
There are no regulations on the private sector in regards to human embryonic stem cell research except at the human clinical trial level. The FDA regulates private industry only during human clinic trials, but not basic research or developmental research. This lack of regulation includes the access and research use of the human embryo. Dangerous embryonic stem cell research is occurring in private industry; but it remains unseen and hidden since the private sector is under no federal regulations or obligation toward oversight. Private industry very often uses trade secret abuse to avoid public criticism and disclosure. Ethical and safety oversight is impossible in private industry since they are not regulated at the basic research level.
Patient Privacy and Hampers Health Research
A new report from the Institute of Medicine finds that the Health
Insurance Portability and Accountability Act (HIPAA) Privacy Rule
—which regulates what uses and disclosures of personally identifiable
health information are permitted by health plans, health care
providers, and other entities covered by the regulation—does not
adequately protect the privacy of people’s personal health information
and hinders important health research discoveries. The
report notes that the current HIPAA rule is difficult to reconcile
with other federal regulations governing research involving people
and their personally identifiable information, and recommends
that Congress authorize the development of an entirely new
approach, separate from the current HIPAA Privacy Rule, to protecting
personal health information in research. This new approach
should apply privacy, data security, and accountability standards
uniformly to information used in all health-related research regardless
of who funds or conducts the research, the report says.
If policymakers decide to continue relying on the current rule to
protect privacy in health research, the committee recommends a
series of changes to improve the rule and the guidance that the
US Department of Health and Human Services (HHS) gives on
how to comply with it. In addition, the report urges all institutions
conducting health research to strengthen their data protection,
including encryption for all laptops, flash drives, and other
portable media containing such data.