Thursday, September 23, 2010

OSHA Continues to Fail Whistleblowers Report Says

Report blasts OSHA efforts to protect whistleblowers

By Lisa Rein

Washington Post Staff Writer
Wednesday, September 22, 2010; A21

The federal agency responsible for worker safety and other protections for tens of millions of Americans has failed for decades to establish a system to shield whistleblowers from retaliation from their employers, according to government auditors.


The Government Accountability Office's report criticizes the Labor Department's Occupational Safety and Health Administration for "ineffective" whistleblower protections that have persisted 20 years after auditors first reported weaknesses.

The stakes have only grown for workers and the public over the last decade, as OSHA - created to ensure safe and healthy working conditions for employees - has expanded its mission. The agency is now charged with enforcing 18 whistleblower laws, covering private employers in the areas of nuclear power, transportation, securities, consumer product safety and the environment.

"For over 20 years, we have repeatedly found that [the agency] lacks sufficient internal controls to ensure that standards for investigating whistleblower complaints are consistently followed," the 46-page GAO report, released last week, concludes.

Auditors described "significant internal control problems" in the whistleblower protection program, adding, "The problems appear systemic, and sustained management attention is needed to address them."

Workers who report on waste, fraud or other prohibited or unlawful practices in the workplace can play a crucial role in making sure federal laws are enforced. But whistleblowers risk reprisals from their employers, including demotion, reassignment and firing, auditors said. Federal laws establish a process for workers who believe they have faced retaliation to report their concerns to investigators.

As President Obama took office in January 2009, auditors conducting one in a long line of reviews of the whistleblower program reported that OSHA investigative teams were short-staffed and lacked adequate training and resources to do their jobs. The investigators also had insufficient oversight by superiors to ensure that complaints were properly investigated. The GAO recommended changes to address the problems.

When auditors returned a year later, most of the problems remained. While some regional offices took whistleblower complaints more seriously than others, many investigators still lacked formal training. The agency's national headquarters lacked accurate files and data to ensure that a case brought to regional office was investigated.

The program is also not routinely audited, and audits that were performed "lacked independence," auditors found.

OSHA has hired 25 new investigators this year, but the process of assigning them to regional offices was "not transparent" - some areas of the country are underrepresented, with a high number of complaints awaiting investigation.Money for the whistleblower program is often not tracked separately from OSHA's general budget, auditors found.

Asked Tuesday why the problems have lingered for two decades, OSHA spokesman Jason Surbey cited a "lack of resources" and said the agency is conducting a "top to bottom" review of the whistleblower program - even though numerous reviews have been done over the years.

"The agency is working hard to ensure that whistleblowers are protected from retaliation," Surbey said in a statement. "The objective is to identify any weaknesses and inefficiencies in the program and improve the ways it conducts this very important activity."

OSHA's director, David Michaels, has been on the job just nine months.

The GAO report comes as efforts heat up in Congress to strengthen whistleblower protections across government. The House has twice passed legislation that would give federal employees the right to sue agencies that retaliate against them for exposing improper actions or policies. Opposition in the Senate to applying such a provision to national security workers is under negotiation.

The new financial regulatory law contains a provision offering cash rewards to individuals who report violations of securities law, while the new health-care law offers protections to caregivers or medical staff who challenge breakdowns in patient safety or denials of coverage by insurance companies.

The Center for Public Integrity reported in July that since 2002, when Congress passed the Sarbanes-Oxley corporate reform law, the Labor Department tossed out 1,066 whistleblower claims of corporate fraud and upheld 25 claims. Michaels said then that he had ordered a review of the agency's handling of those cases and other whistleblower statutes.

"OSHA failed to deliver on nearly all the commitments made by the Obama administration for so many corporate whistleblowers," said Tom Devine, a whistleblower advocate and legal director of the Government Accountability Project. "We hope the [report] will be a healthy wind at the back of those toiling inside the agency."

UC Davis Whistleblower Case Setttles

UC Davis pays settlement to whistleblower faculty member


Internal investigation verifies claim of retaliation
Written by Kyle Sporleder
Staff Writer
Published on Aug 9, 2010
 
On June 16, Dr. Amy Block Joy settled a claim that she was subjected to retaliation following her whistleblower complaint against a fellow employee in August 2006 with a payment of approximately $785,000, including paid administrative leave and placement in a new position.

Joy, a nutrition specialist, made allegations of fraudulent activities against Beverly Benford, a former employee of Food Stamp Nutrition Education Program for which Joy was formerly director.

After a three-year process involving an investigation and negotiation for the monetary settlement, Joy's attorney, Michael Hirst, expressed satisfaction with the case's conclusion.

"Dr. Block Joy did what she knew was right and stood up to those who wanted her to fail," Hirst said. "She showed strength and determination throughout this case."

According to Joy, she discovered what appeared to be embezzlement in March 2006. After a failed attempt to resolve the issue through university channels, Joy filed an official whistleblower complaint. Immediately afterward, she experienced her first case of retaliation, she said.

The vengeance intensified following each stage of the process, including times when a warrant was served to Benford in October 2006, a Sacramento Bee article was published in early 2007, and again after Joy's complaint alleging retaliation in September 2007.

According to her complaint, Joy was subject to lies, mail theft, vandalism and a lack of cooperation from subordinates.

"I discovered rather quickly that the best way to handle the retaliation was to hold my head up high, answer all the investigative questions truthfully and focus on doing the best job I could do," Joy said.

Benford was eventually indicted on charges of theft of government property and, in 2008, plead guilty resulting in a sentence of one year and one day in prison in addition to being ordered to pay $128,681 in government restitution.

Joy theorized that Benford had been shielded by "higher-ups" because she had helped others acquire equipment for campus operations while circumventing restrictions for such actions. Joy also felt that she was made into a scapegoat following her complaint for those that retaliated against her.

In a press release following the settlement, Hirst shared his view on dealing with retaliation.

"Any effective policy encouraging employees to come forward must ensure their protection," Hirst said. "Too often, those who blow the whistle regret doing so because of on-going retaliation they experience."

Last month, Gov. Arnold Schwarzenegger signed into law SB 650, authored by State Senator Leland Yee, which offers protections for UC employees that report illegal or improper actions from retaliation in the workplace.

Although Joy believes that her case was handled professionally and fairly by the university, she also sees SB 650 as a positive step in encouraging employees to report illegal activity and to protect them once they do.

However, Robert Loessberg-Zahl, assistant executive vice chancellor and locally designated official to receive whistleblower complaints, believes that the guidelines the university already has in place are sufficiently effective.

"The university has long been committed by its policies and procedures to ensure that allegations of whistleblower retaliation are thoroughly investigated," Loessberg-Zahl said. "[Senate Bill 650] does not change the policy or procedures that the University has in place for internally handling whistleblower allegations."

Regardless of the debate over the usefulness of the changes SB 650 will implement, both parties agree that reporting of illicit or illegal actions of employees by employees is often the only way such occurrences are brought to light.

Joe Kiskis, professor of physics and vice president of external relations for the council of UC faculty associations, which supports SB 650, argues that UC employees are the most likely to possess pertinent information for such investigations but are least likely to share it due to the fear of retaliation.

"To protect the mission of the University and the interests of California citizens, it is important to bring problematic behavior to light and correct it," Kiskis said. "Employees who provide that beneficial service to the public need to be protected from retaliation."

KYLE SPORLEDER can be reached at campus@theaggie.org.

Wednesday, September 22, 2010

Bioethical Issues on Human Embryonic Stem Cell (3)_for the student and the school class

Bioethics is a study of the philosophical and ethical controversies surrounding advances in biology and medicine.  Embryonic stem cell research is a bioethical issue because it requires the use and destruction of human embryos.  Some people feel that this is not right, not ethical.  Some even feel it is not moral, that is, against their religious beliefs.  Many people are ambivalent and have contradictory attitudes about if this is right or wrong.  Others believe nothing is unethical or immoral about human embryonic stem cell research.

See the video below to try to understand some of the bioethical issues and scientific issues behind embryonic stem cell research:



How does Dr. Cohen (on left) answer the question..."Do we expect to see significant impacts on cures for diseases using stem cell research within the next 10 years?

What study of diseases may benefit  in using stem cell research?

What does Dr. Cohen say is a scientific limitation to using embyronic stem cells? 

What does Dr. Cohen say may be one of the problems in giving embryonic stem cells to patients?

There are three type of stem cells that scientists research.  Can you identify these three types of stem cells discussed in this video?

Does morality come down to a sense of proportionality?  That is, if you do something that causes more good than harm, can you then say that it is ethical and moral? Can you explain why this is a relevant issue with embryonic stem cell research?  What does Fr. Pacholczyk say about moral proportionality?

Do you understand what it means to clone human beings?  Do you understand what it means to gestate cloned human embryos?  What does our law say about cloning human beings?  Where does the law draw the line?

Can you find which company in California is alleged to have cloned human beings?

Why does Dr. Cohen talk about cell reprograming?  Why does that solve some ethical issues related to embryonic stem cell research?  Why does Fr. Pacholczyk say it might be safer also?

What factors do you think are important for responsible and ethical research in US?

other links:
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic.html
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic_22.html

Bioethical Issues on Human Embryonic Stem Cell (2)_When Does Life Begin?_for the student and the school class

When does Life Begin?  Is the answer to this question a human rights issue, a religion issue or a scientific issue as it relates to Embryonic Stem Cell Research?

Bioethics is a study of the philosophical and ethical controversies surrounding advances in biology and medicine.  Embryonic stem cell research is a bioethical issue because it requires the use and destruction of human embryos.  Some people feel that this is not right, not ethical.  Some even feel it is not moral, that is, against their religious beliefs.  Many people are ambivalent and have contradictory attitudes about if this is right or wrong.  Others believe nothing is unethical or immoral about human embryonic stem cell research.

One of the bioethical issues in embryonic stem cell research is the answer to the question "When does life begin?"  This is an important question especially since the government can define the answer to this question by enacting law.  A law defining "when life begins" can negatively impact our rights as American citizens in many ways. 

See this video to try to understand the issue of "when does life begin?".  See the questions below to help you understand some of the specific controversial points surrounding this issue.



Do you know what conception is?

What did a famous theologian, Thomas Aquinas, say about when life began?

What limitations did Thomas Aquinas have in being able to answer this question adequately?

How did the scientist/bioethicist on the right (Fr. Pacholczyk) answer the question of "when does life begin"?

What did the scientist on the left (Dr. Kohen) say about how life might be defined and by what criteria instead?

Can science ever determine when the "soul" enters an embryo?  Why does Fr. Pacholczyk say that is not important in answering the question of "when does life begin"? 

Why would a priest say the issue is not a religion issue?  What type of issue does Fr. Pacholczyk call it instead?

Do you think Dr. Kohen is confusing religion with human rights?

Can you think of a way of how a law defining "when life begins" could possibly negatively impact human rights to have children?


More links:
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic.html
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic_3603.html

Bioethical Issues on Human Embryonic Stem Cell_for student and the school class

Bioethics is a study of the philosophical and ethical controversies surrounding advances in biology and medicine.  Embryonic stem cell research is a bioethical issue because it requires the use and destruction of human embryos.  Some people feel that this is not right, not ethical.  Some even feel it is not moral, that is, against their religious beliefs.  Many people are ambivalent and have contradictory attitudes about if this is right or wrong.  Others believe nothing is unethical or immoral about human embryonic stem cell research.

Bioethical issues often become political issues.  Watch this video.  See if you are able to understand the bioethical and political issues that are involved in embryonic stem cell research and which are specifically discussed in this video.  See the questions below to guide your understanding.



What are the backgrounds of the two scientists?  Why do they have the interest and expertise to talk about embryonic stem cells?

What is a bond issue?  Why would a bond issue be important to you and your family?  Why is this particular bond issue important for the scientist, Dr. Cohen?

Did the citizens of New Jersey vote in favor of the bond or against it?

How much money in the bond issue was turned down by the voters?

What are the two reasons given of why the voters in New Jersey turned down a bond issue to fund embryonic stem cell research in their State?

Did the scientist, Dr. Cohen ever give a clear answer to the question, "is it possible to see mass production of cures through embryonic stem cells in our life time?

What is hype?  Why would someone want to use hype in the media?

What did the scientists/bioethicist Fr. Pacholczyk talk about when he said it was important to distinguish the "hype from the concrete truth when we discuss complex issues?  What specific type of hype does the scientist/bioethicists Fr. Pacholczyk refer to? What example does he give about the unrealistic way the embryonic stem cell community has painted a picture about fear?

Were these issues of a political nature or of a bioethical nature?

Think about these issues and comment if you cannot answer any of these questions.

More links:
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic_22.html
http://watchdogonscience.blogspot.com/2010/09/bioethical-issues-on-human-embryonic_3603.html

The Reasons NOT to Invest in Pfizer Keep Rolling In!

U.S. Joins Pfizer Suit Over Drug’s Marketing

By DUFF WILSON

NY Times
Published: September 21, 2010

The Justice Department on Tuesday joined a whistle-blower lawsuitagainst Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.
Reuben A. Guttman, lawyer for two former Wyeth employees, predicted that the government action could result in recovery of hundreds of millions of dollars in inappropriate billings to public health programs. Nineteen states, including New York, and the District of Columbia also joined the filing.


“It’s always good to have the government on your side,” Mr. Guttman said.

Ray Kerins, a Pfizer spokesman, said the company had previously disclosed that it was cooperating with a government review of Wyeth’s promotional practices involving Rapamune. Pfizer also disclosed in February that there was a criminal investigation into the marketing.

In a statement, the company said the whistle-blower suit was filed in 2005, four years before Pfizer bought Wyeth for $68 billion. Pfizer could be in violation of a corporate integrity agreement it signed a year ago in a separate case if it was involved in further illegal sales.

In that case, Pfizer paid $2.3 billion, including a $1.3 billion criminal fine, the largest in United States history, to settle investigations into illegal marketing of the painkillers Bextraand Lyrica, the schizophrenia drug Geodon and the antibiotic Zyvox.

Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington nonprofit group that works with many whistle-blowers under the federal False Claims Act, said the government nearly always wins when it joins such a legal action.

“It’s going to be a big case,” Mr. Burns said. “The wild card is, it’s Pfizer. The government’s not happy with Pfizer. These are repeat offenders.”

Charles S. Miller, a spokesman for the Justice Department, declined to comment, saying the brief government filing spoke for itself. Such cases are typically shrouded in confidentiality.

The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit ofForest Laboratories for $313 million.

Rapamune had sales of $376 million in 2008. The law allows the government to collect up to three times any amount it was defrauded and pay whistle-blowers 15 to 25 percent of the total. Mr. Guttman said most of those sales were for uses not approved by the Food and Drug Administration.

While doctors can use an approved drug for anything they see fit, companies are prohibited from marketing drugs for uses not approved by the F.D.A.

In the whistle-blower suit, filed in United States District Court in Philadelphia, the former employees, Marlene Sandler and Scott Paris, said they were encouraged to promote the drug for heart, lung, liver and pancreas transplants, even though the F.D.A. had only approved it, in 1999, for kidney transplants.

The suit also contends that Wyeth singled out two hospitals with largely black clients for off-label promotions. They were the SUNY Downstate Medical Center in New York and theAlbert Einstein Medical Center in Philadelphia. Black patients have higher risk oftransplant rejection. The Pfizer statement on Tuesday said that Wyeth was allowed to market Rapamune for that population.

The Justice Department during the Bush administration declined to join in the Rapamune case. Mr. Guttman praised the Obama administration for aggressive action.

Mr. Burns said the civil division of the Justice Department, which handles the cases, has been nonpolitical and commonly joins an action, after first declining, once new information emerges. He also said the health care reform overhaul strengthened the False Claims Act and increased money for enforcement.

http://www.nytimes.com/2010/09/22/business/22drug.html?_r=1&scp=1&sq=U.s.%20Joins%20Pfizer&st=Search

Tuesday, September 21, 2010

Big Money...the Pfizer-Government Influence


Pfizer spent $2.3 million lobbying federal government in 2Q on health, economic issues
Associated Press

09/20/10 5:00 AM PDT

NEW YORK — Pfizer Inc., the world's biggest drugmaker, spent $2.3 million lobbying Congress and federal agencies in the second quarter on health care reform and other health economic issues, according to a recent filing.

The maker of cholesterol blockbuster Lipitor, impotence pill Viagra and children's vaccine Prevnar reduced its spending on lobbying in the second quarter by 60 percent compared with a year ago when its lobbying cost $5.6 million. It is also down 48 percent from the $4.3 million in the first quarter of this year.

New York's Pfizer lobbied on multiple trade agreement issues, including China, South Korea, and Mexico. It also lobbied on health care reform issues, including the use of research comparing the effectiveness of medications and other types of treatment, health information technology, and veterans health issues.

During the April to June period, the company also lobbied on patent reform and prices and rebates for drugs bought through government programs such as Medicare and Medicaid.

Besides Congress, Pfizer lobbied the White House, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the U.S. Patent and Trademark Office and the departments of Commerce, State, Veterans Affairs and Health and Human Services, according to the July 20 filing with the House clerk's office.

http://www.sfexaminer.com/economy/pfizer-spent-23-million-lobbying-federal-government-in-2q-on-health-economic-issues-103272184.html

The Trial and Tribulations of Whistleblowers____Secrets Against the Public

Shhhhhh.  It's a SECRET.
Don't let the pubic know!
ACLU challenges limits in whistleblower law


Posted by afp on Sep 20, 2010 in Government and Politics
http://augustafreepress.com/2010/09/20/aclu-challenges-limits-in-whistleblower-law/

Lawyers for the American Civil Liberties Union will present oral arguments in the Fourth Circuit Court of Appeals tomorrow in a lawsuit challenging the overreaching secrecy provisions of a federal whistleblower law that prevents the public from learning about serious allegations of fraud against the United States government.

Complaints filed under the False Claims Act are automatically placed under seal and those who file them are gagged from speaking, keeping the complaints secret from the public for months and, in some cases, years.

Such complaints include allegations of military contractor fraud during the Iraq War and warnings of ongoing threats to public health and safety.

The ACLU and the ACLU of Virginia filed suit in U.S. District Court in Alexandria in January 2009 on behalf of themselves, the Government Accountability Project (GAP) and OMB Watch. The government filed a motion to dismiss, which was heard in June 2009. In August 2009, the district court granted the government’s motion. The ACLU then appealed to the Fourth Circuit.

The case is ACLU v. Mukasey. Attorneys on the case are Chris Hansen and Ben Wizner of the ACLU and Rebecca Glenberg of the ACLU of Virginia.

The ACLU’s appellate briefs are available at http://acluva.org/wp-content/uploads/2010/09/4th-circuit-opening-brief.pdf and http://acluva.org/wp-content/uploads/2010/09/Reply-Brief-for-Appellants-ACLU-v.-Holder-2010.2.9.pdf.

The district court complaint is available at http://www.aclu.org/free-speech/aclu-et-al-v-mukasey-et-al-complaint.

Spying on the Internet. FCC Not Interested in Privacy. What Do You Expect?

A NY Times article published yesterday describes a major problem regarding computer privacy with companies that track computer users' activity on the internet using flash cookies.  The FCC has ignored the public's privacy protections. 

What the NY Times article does not mention is the fact that the government actually contracts with these and other "spying" companies to obtain this same information and more on American citizens.  Does anyone expect protection from the government regarding our privancy?  Don't hold your breath.

The good thing is that some individuals are stepping up to the plate and trying to stop this type of spying by suing the companies directly.

Read NY Times article here:  http://www.nytimes.com/2010/09/21/technology/21cookie.html?_r=1&th&emc=th

Saturday, September 18, 2010

Dr. Woo, Gene Therapy and Scientific Misconduct

Why do scientists cheat?


Two unidentified post-docs from Mount Sinai School of Medicine have been terminated due to an investigation of scientific misconduct regarding falsification of data in three renown scientific journals related to gene therapy.

The work came from the research lab of Savio Woo, a leading gene therapy scientist studying phenylketonuria.

Gene therapy is an advanced biotechnology that uses genetically engineered infectious agents to target cures for human genetic diseases. Gene therapy is controversial because it has caused the deaths of patients in the past.

Despite the embarrassment, it is of value that Mount Sinai has taken disciplinary action against these scientists. It would be beneficial, however, to hear the other side of the story, making sure that these scientists have not been falsely accused. It also would be beneficial to address the reason why this scientific misconduct was not discovered earlier. 

Falsifying data has happened in the past in the scientific world.  It does, however, seem suspicious that TWO scientists would collude to falsify data.

http://topnews.com.sg/content/24918-researchers-dismissed-following-scientific-misconduct-gene-therapy-lab

http://retractionwatch.wordpress.com/2010/09/23/gene-therapy-researcher-savio-woo-retracts-two-more-papers/

http://retractionwatch.wordpress.com/2010/09/15/work-from-noted-gene-therapy-research-under-scrutiny-with-slew-of-retractions/

Friday, September 17, 2010

What Happens When Biotech Buys a University?

The Sad Saga of Ignacio Chapela


academic freedom in chains
by John Ross
Feb 18, 2004
 
How to destroy Mexican corn, reap maximum profits, and buy a university in one easy lesson...


Seated on the balcony of his appropriately professorial office upon a sun-stroked hillock in the midst of the Life Science complex on the hallowed Berkeley campus of the University of California, the controversial Mexican-born microbiologist Ignacio Chapela, an academic who has dared to lock horns with the potentates of Big Biotech, reflected upon the tenuous status of his employment. "They will never forgive me here," the curly-haired, Cupid-mouthed Chapela sighed disconsolately, his gaze fixed upon the Campanile, the Berkeley campus's most recognizable landmark, as if it were a stand-in for Chancellor Robert Berdahl himself.

For story go to this link:  http://theava.com/04/0218-chapela.html

Thursday, September 16, 2010

Gene Therapy-- Initial Success but Caution for B-thalassaemia Patient

A patient with B-thalassaemia, a genetic blood disorder, has shown promising results from a gene therapy treatment.  Researchers review this result, however, with caution. The initial promosing results may be due to a pre-cancerous condition caused by the gene therapy agent itself.  This pre-cancerous condition would exelerate the growth of the cells containing the gene therapy agent providing positive therapeutic results...but later could cause cancer.  The patient already is expressing a pre-cancer marker called HMGA2.  Let's keep our fingers croossed for a good outcome for this patient.

Below is a article from Nature.


Gene-therapy hope for β-thalassaemia patients
Published online 15 September 2010

Nature
doi:10.1038/news.2010.470
 
A defective haemoglobin gene has been successfully replaced with a healthy copy.

Joseph Milton

Gene therapy for a form of β-thalassaemia, a genetic disorder whose sufferers require frequent blood transfusions because they cannot properly produce red blood cells, seems to have been successful in a patient who, three years after treatment, no longer requires transfusions1. Doubts remain, however, over whether a set of lucky circumstances is behind the success.


Patients with β-thalassaemia carry faulty copies of the genes needed to produce the β-globin chain of haemoglobin, sometimes lacking the genes altogether. This leads to a shortage of red blood cells, the body's oxygen carriers.

Sufferers must have regular blood transfusions throughout their lives, an inconvenient and debilitating regime that ultimately shortens life expectancy. The only known cure is stem-cell transplantation, but few patients are able to find a suitable donor.

Because of the gruelling nature of this treatment, the development of gene therapies for β-thalassaemia is seen by many as an exciting prospect. The subject of the latest trial was an 18-year-old man with βE/β0-thalassaemia — in this form of the disease, one copy of the β–globin gene produces unstable β-globin and the other copy is non-functional.

Around half of the patients with this form of β-thalassaemia are dependent on transfusions, and the patient concerned had received blood transfusions since the age of three.

Philippe Leboulch of Harvard Medical School, part of the team that carried out the study, described the treatment as "life-changing". "Before this treatment, the patient had to be transfused every month. Now he has a full-time job as a cook," he says.

Unrepeatable?

However, Michael Antoniou of King's College London, suggests that this case was "an extremely fortuitous event", and that the positive outcome seen is unlikely to be repeatable in other patients.

The procedure was carried out as follows. In 2007, an international team led by Marina Cavazzana-Calvo of University Paris-Descartes extracted haematopoietic stem cells (HSCs) from the patient's bone marrow. These cells give rise to all blood cell types, including the haemoglobin-containing red cells. The researchers cultured these cells, and mixed them with vectors based on the lentiviruses — a retrovirus subgroup with a long incubation period — into which a functional copy of the β-globin gene had been introduced. These vectors were shown in preclinical trials to be safer than those derived from the retroviruses — which are also replicated in a host cell — that have been used in previous gene-therapy procedures.

Chemotherapy was used to eliminate as many of the patient's faulty HSCs as possible, to prevent dilution of the genetically corrected cells, which were then transplanted. Levels of healthy red blood cells and normal β-globin in the subject's body gradually rose until, around a year after the treatment, he no longer required transfusions. After 33 months he remains mildly anaemic, but the fact that he remains transfusion-free has been hailed as a success.

However, that achievement is tempered by a cautionary note. The researchers have detected overexpression of a protein called HMGA2, which has been linked to cancers, in a high proportion of the genetically modified cells.

Overexpression occurred because the lentivirus vector can randomly integrate into chromosomes. By chance, one transplanted haematopoietic cell clone contains a vector insertion in the HMGA2 gene. A year after the transplant, the researchers noticed that the proportion of genetically modified cells that originated from this particular cell clone was rising until it reached a plateau at around 50%.

The reasons for the over-representation of that particular clone remain unclear, but that could be down to the fact that the patient's haematopoietic system was reconstituted from just a few modified HSCs. Luigi Naldini, a gene-therapy researcher at San Raffaele Telethon Institute for Gene Therapy in Milan, Italy, says that successfully grafting a larger initial population of modified HSCs could potentially prevent the problem from developing.

Looking at the haematopoietic system in its entirety, the researchers found that increased levels of HMGA2 were present in only about 5% of the patient's circulating cells, but overexpression of HMGA2 has led to enlargement of the patient's red blood cells. The researchers say that this enlargement caused by the overexpression of HMGA2 could be partly responsible for the therapeutic benefits, but it could also be a signal of future malignancies.


Antoniou suggests that the HMGA2 effect is "key" to the therapeutic effect, and that without the unintended insertion, combined with the patient's ability to produce some β-globin naturally, transfusions would probably still be required.

But Leboulch says that β-globin production from the modified cells was just as high before the cells containing the insertion reached the 50% mark, so that most of the therapeutic effect must be due to the implanted modified cells, rather than the expansion of the blood cells caused by the HMGA2 insertion. And Naldini says that the fact that β-globin expression by the implanted cells is being seen at all represents a major step forward.

References

1.Cavazzana-Calvo, M. et al. Nature 467, 318-322 (2010).

http://www.nature.com/news/2010/100915/full/news.2010.470.html
OSHA, the agency scorned by labor haters, has been meek and weak

Corporations scoff at workers' rights--even the right to come home from work alive
 
http://www.hightowerlowdown.org/node/2420
from Hightower Lowdown
edited by Jim Hightower and Phillip Frazer
 
Their names probably won't mean mean anything to you, but these people ought to have some modicum of personal recognition: Jason Anderson, Aaron Dale "Bubba" Burkeen, Donald Clark, Stephen Curtis, Gordon Jones, Roy Wyatt Kemp, Karl Kleppinger, Blair Manuel, Dewey Revette, Shane Roshto, and Adam Weise. These are the 11 workers who were killed when the Deepwater Horizon oil rig exploded and sank into the Gulf of Mexico on April 20.


Four months after the disaster, national media outlets continue extensive coverage of BP's calamitous well--as they should--showing us satellite pictures of the spreading plumes of pollution, footage of dead pelicans, estimates of the ecological horror on the ocean floor, analyses of the frantic efforts to stop the oil, commentaries on the astonishing arrogance of corporate executives, feature stories about the slick's impact on Gulf tourism, interviews with lawmakers demanding much tougher environmental protections, etc...

But what about those people? Most of the 11 were in their twenties and thirties. They had families and futures. Yet, aside from an occasional off-handed reference to the general body count, their fate had pretty much been dropped from discussion about the cost of our country's cavalier ethic of "drill, baby, drill." And what about the 17 other rig workers who were injured in the Deepwater explosion, many of them badly burned and maimed. There's barely been any media mention of the price they paid for the corporate rush to complete this well, much less any follow-up on their painful and costly ordeal.

I'm not pleading here for maudlin coverage of victims--but for ACTION! Just as the Deepwater catastrophe is a screaming wake-up call and a vital teaching moment for environmental protection, so it is for the protection of America's workforce. Eleven people didn't merely perish in the Gulf on April 20; they were killed by a careless cabal of corporate greedheads and ideological boneheads. It's a case of institutional murder--and it's a shockingly common occurrence in our country.

Tuesday, September 14, 2010

Embryonic Stem Cell Research Funding Threatens Human Rights and Public Interest


Human Rights at Risk with Public Funding of Embryonic Stem Cell Research

By Becky A. McClain

As an embryonic stem cell scientist and an injured worker, I would caution the public about the recent political movement to reverse the Dickey Amendment and, thereby, legalize federal funding for embryonic stem cell research. Matter a fact, the public should be alarmed.


Why?

Disregard for human rights issues, which rise up and above the “religious right” concerns, have already adversely impacted the public. And, unfortunately, more adversities toward the public are on their way as embryonic stem cell research advances. These critical issues deserve thoughtful attention before a reversal of the Dickey Amendment should be even considered.

I should know.

I was denied directed medical care for exposures from dangerous embryonic stem technologies incurred while at work. Unbelievably, I was denied under the premise that “trade secrets” supersede a worker’s right to specific exposure information.

Really? Yes, really.

Welcome to the embryonic stem cell world, a world of legal quagmire where human rights and public rights are slated toward the chopping block. Chop! Chop! One down for worker’s rights.

Public Beware. If the embryonic stem community does not care about worker safety and worker rights, you had better believe they also do not care about public rights or public safety either.

In fact, the public has been fooled. The embryonic stem cell research industry is far from the altruistic persona it has painted itself to be. Rather, embryonic stem cell research is about big money, first and foremost. It is about securing a position of power within the economic and legal mainstream of the American public. That is why biotech worker’s rights regarding safety and healthcare have been denied. That is why, unfortunately, the public’s right will be denied too.

And the media has not helped. The media has purposely turned the human embryonic stem cell debate into a polarized “religion versus science” contest.

But issues lying in-between those two polarities contain much of the tainted meat that can negatively impact the public toward human rights. These concerns get no media attention. The public remains ignorant. In fact, the public lacks an understanding of the legal, social and cultural effects that could negatively impact them as advanced technologies move forward.

The “religious right” issue is only one of many concerns surrounding the controversial funding of human embryos for research. But it is not, necessarily, the most important.

For example, public health and safety is yet another concern in this unregulated research. But the public remains clueless. The public is not even aware that human embryos are being used for biological warfare research purposes in the United States.

The public is also not aware that other dangerous embryonic stem cell technologies are being developed in their neighborhood universities and biotech companies without adequate biocontainment measures, regulations or oversight. The public is not aware of how this unregulated and dangerous research can make them sick. Real sick.

And that’s not all. Human rights, scientific integrity, public transparency, patent issues, public rights, women’s rights, egg donations, workers rights, and legal rights, along with public health and safety are all important issues that have been left out of the human embryonic stem cell debate.

Under the current lack of public and human right protections, Americans should be on guard regarding allowing unfettered public funding toward human embryonic stem cell research.

It is in the public’s best interest to protect itself. And I assure you, as an embryonic stem cell researcher and injured worker, who has seen the dark side of the embryonic stem cell industry and who has personally experienced its immense power to thwart human rights, reversing the Dickey Amendment is far from being in the public’s interest.

Until the legal, social and cultural effects of human embryonic stem cell research can be brought to light, with more meaningful discussions to protect the rights and interests of the American people, the public should demand upholding the Dickey Amendment. The public should not advocate for public funding toward human embryonic stem cell research.

Becky McClain is an injured biotechnology worker who while working as a molecular biologist at Pfizer, Groton, became ill after she incurred exposures to dangerous genetically engineered viruses used in an embryonic stem cell lab. She recently won a freedom of speech and whistleblower claim in federal court against Pfizer which involved her public health and safety claims.

Biotech Company to Patent Fuel-Secreting Bacterium

By MATTHEW L. WALD
NYTimes Sept 13, 2010
 
A biotech company plans to announce Tuesday that it has won a patent on a genetically altered bacterium that converts sunlight and carbon dioxide into ingredients of diesel fuel, a step that could provide a new pathway for making ethanol or a diesel replacement that skips several cumbersome and expensive steps in existing methods.


The bacterium’s product, which it secretes like sweat, is a class of hydrocarbon molecules called alkanes that are chemically indistinguishable from the ones made in oil refineries. The organism can grow in bodies of water unfit for drinking or on land that is useless for farming, according to the company, Joule Unlimited of Cambridge, Mass.

“We make very clean, sulfur-free hydrocarbons that drop directly into the existing infrastructure for the production of diesel fuel,” said William J. Sims, the chief executive of Joule. The object, he said, was not to be an alternative for fossil fuels, but “to become a viable replacement.”


Joule said it was the first company to patent an organism that secretes hydrocarbon fuel made continuously, directly from sunlight. Other companies, including Amyris Biotechnologies of Emeryville, Calif., and LS9 of San Carlos, Calif., are working on organisms that will make fuel if fed sugar from corn or cellulosic sources, but Joule’s bacterium does not require any sugar. Another company, Aurora Algae of Alameda, Calif., said Monday that it had developed an algae-based platform for production of fuel, pharmaceuticals and other valuable chemicals.

Development of a photosynthetic organism to make hydrocarbons is “an important step,” said Eric J. Toone, the deputy director for technology at the Advanced Research Projects Agency-Energy, a new agency within the Energy Department that makes grants for high-risk, high-reward projects. But Mr. Toone and others cautioned that there were other steps to be mastered before such a technology could be commercialized.

The organism is a cyanobacterium, also known as blue-green algae, although it is technically not an algae. It produces the fuel using photosynthesis, the process that plants use to make sugars and other materials from water, carbon dioxide and sunlight.

Alternative energy experts agree that photosynthesis is a promising avenue for biofuel research. The challenge is turning the resulting product into a fuel. Many companies are trying to develop an algae to do that job. But it requires energy to separate the algae from the water and then process the oil they make internally into a usable fuel. An organism that secretes the desired product directly avoids both problems.


In a test in Leander, Tex., Joule’s bacteria strain produced ethanol. Different variants can also make polymers and other high-value chemicals that are ordinarily derived from petroleum, according to Joule.

The system can run on the carbon dioxide in ordinary air but will do better using the exhaust from a power plant, once pollutants like sulfur and nitrogen oxides have been removed, according to the company.

Joule said it would begin construction next year on a commercial plant, which it hopes will begin operations in 2012. The company predicts a yield of 15,000 gallons of diesel components per acre — far more fuel than an acre of corn grown for ethanol can produce.

Mr. Sims says the pilot project covers a little less than five acres. Because the process is modular, he said, a full-scale factory would simply mean making multiple copies of a smaller setup. And with a small amount of refining, he said, the hydrocarbons can be converted to an ingredient of jet fuel.

An independent expert, Matthew C. Posewitz, a professor at the Colorado School of Mines, said that making an organism that secreted hydrocarbons was “definitely one of the most active areas in the whole game right now.”

He said that Joule did not yet have a proved process, but that it had strong research and development capabilities. “They have some extreme horsepower within that company,” he said.

ref:  http://www.nytimes.com/2010/09/14/science/earth/14fuel.html?src=un&feedurl=http%3A%2F%2Fjson8.nytimes.com%2Fpages%2Fscience%2Findex.jsonp

Genetics and Imprinting

Excerpts from:
Tug of War Pits Genes of Parents in the Fetus


By NICHOLAS WADE
Published: September 13, 2010
NY Times
 
Under Mendel’s laws of inheritance, you could thank mom and dad equally for all the outstanding qualities you inherited.


But there’s long been some fine print suggesting that a mother’s and father’s genes do not play exactly equal roles. Research published last month now suggests the asymmetry could be far more substantial than supposed. The asymmetry, based on a genetic mechanism called imprinting, could account for some of the differences between male and female brains and for differences in a mother’s and father’s contributions to social behavior.

A person gets one set of genes from each parent. Apart from the sex chromosomes, the two sets are equivalent, and in principle it should not matter if a gene comes from mother or father. The first sign that this is not always true came from experiments in which mouse embryos were engineered to carry two male genomes, or two female genomes. The double male and double female mice all died in the womb. Nature evidently requires one genome from each parent.

Biologists then made the embryos viable by mixing in some normal cells. The surprising outcome was that mice with two male genomes had large bodies and small brains. With the double female genome mice, it was the other way around. Evidently the maternal and paternal genomes have opposite effects on the size of the brain.

The root of the asymmetry is a procedure called imprinting in which either the mother’s or the father’s copy of a particular gene is inactivated. The best worked out example concerns a gene called insulinlike growth factor-2, which promotes the growth of the fetus. The IGF-2 gene is active in the paternal genome but imprinted or inactivated in the genome the fetus receives from its mother.

....
Until last month only a hundred imprinted genes were known, and the mechanism seemed just an interesting deviation from Mendelian genetics. Research led by Christopher Gregg and Catherine Dulac of Harvard has shown that imprinting is far more common and more intricate than supposed.


Working in mice, the Harvard team showed that around 1,300 genes are imprinted. Dr. Dulac said that she expects a substantial, though lesser, proportion to be imprinted in people — maybe some 1 percent of the genome — because humans are more monogamous than mice and so the parents’ interests are more closely aligned.

Dr. Dulac was able to detect so many new imprinted genes by taking advantage of the ease with which genes can now be decoded. She cross-bred two very different strains of mice, thus ensuring that the maternal and paternal versions of each gene would have recognizably different sequences of DNA.

When a gene is activated, the cell transcribes it into RNA, DNA’s close chemical cousin. By decoding all the RNA transcripts in the mouse’s cells, Dr. Dulac could pick out those genes in which the paternal version was being transcribed much more than maternal version, and vice versa.

Besides finding far more imprinted genes than expected, Dr. Dulac’s team also picked up unexpected patterns in the way the genes were expressed. Maternal genes were more active in the embryo’s brain, but paternal genes became more active in the adult.

In another novel pattern, she found sex differences in imprinted genes in different region of the brain, particularly those concerned with feeding and with mating behavior. A gene called interleukin-18 is activated from the mother’s version in two important regions of the brain. This asymmetry is of interest because the gene in people has been linked with multiple sclerosis, a disease that predominates in women.

Altogether Dr. Dulac found 347 genes where either the mother’s or the father’s copy was more actively expressed in certain regions of the brain. Sex differences in the brain are usually attributed to the influence of hormones, but sex-based differences in imprinting may be another mechanism by which nature spins male and female brains out of the same genome.

“In your brain, your mom and your dad keep telling you what to do — I keep laughing when I think about it,” Dr. Dulac said.

In the cortex of the brain, Dr. Dulac discovered another unexpected asymmetry. Women have two X chromosomes, one from the mother and one from the father. The usual rule is that in each cell either the mother’s or the father’s copy is chosen at random to be switched off. But in the neurons of the cortex, there is a much greater chance that the paternal X chromosome will be switched off. “So again, it’s the conflict between mom and dad — each tries to use different chromosomes to influence you,” Dr. Dulac said.


For complete NYT article go to link: http://www.nytimes.com/2010/09/14/health/14gene.html?th&emc=th

Monday, September 13, 2010

Bought And Paid For_the Selling of the Academic Community


The Secret Lives of Big Pharma's 'Thought Leaders
September 12, 2010
By Carl Elliott

'In the early 1970s, a group of medical researchers decided to study an unusual question. How would a medical audience respond to a lecture that was completely devoid of content, yet delivered with authority by a convincing phony? To find out, the authors hired a distinguished-looking actor and gave him the name Dr. Myron L. Fox. They fabricated an impressive CV for Dr. Fox and billed him as an expert in mathematics and human behavior. Finally, they provided him with a fake lecture composed largely of impressive-sounding gibberish, and had him deliver the lecture wearing a white coat to three medical audiences under the title "Mathematical Game Theory as Applied to Physician Education." At the end of the lecture, the audience members filled out a questionnaire.

The responses were overwhelmingly positive. The audience members described Dr. Fox as "extremely articulate" and "captivating." One said he delivered "a very dramatic presentation." After one lecture, 90 percent of the audience members said they had found the lecture by Dr. Fox "stimulating." Over all, almost every member of every audience loved Dr. Fox's lecture, despite the fact that, as the authors write, it was delivered by an actor "programmed to teach charismatically and nonsubstantively on a topic about which he knew nothing."

It is tempting to imagine that the Dr. Fox study reveals a deep flaw in the structure of medicine—for example, that health-care workers are too trusting of authority, or that Continuing Medical Education (CME) lectures are a sham. But what the study actually reveals may be something closer to the opposite. If medicine were simple and transparent, pretending to be a medical expert would be very difficult. An audience could spot incompetence right away. Pretending to be a medical expert is possible precisely because medical knowledge is so specialized and opaque. These days an ordinary doctor can no more expect to understand the intricacies of specialized medical research than the driveway mechanic who tinkered with his Volkswagen in 1962 can expect to fully understand the complex, computerized automobiles on the road today. Those who have tried to sit through a medical lecture in a field other than their own will secretly admit that they could have been fooled by Dr. Fox as well.

Since the 1950s, marketers have been taken with the idea that when it comes to spreading the word about unfamiliar products or ideas, some people are far more important than others. The phrase "opinion leader" was made familiar by the sociologists Paul Lazarsfeld and Elihu Katz in their 1955 book, Personal Influence, where they used the term to explain the way that media messages were filtered and spread by personal, face-to-face contact with influential people. It is not hard to see why marketers liked this idea. Mass-media advertising can be expensive. What if there were a way to avoid the masses and simply concentrate on the special people? Today the pharmaceutical industry uses the terms "thought leader" or "key opinion leader"—KOL for short—to refer to influential physicians, often academic researchers, who are especially effective at transmitting messages to their peers. Pharmaceutical companies hire KOL's to consult for them, to give lectures, to conduct clinical trials, and occasionally to make presentations on their behalf at regulatory meetings or hearings.

The KOL is a combination of celebrity spokesperson, neighborhood gossip, and the popular kid in high school. KOL's do not exactly endorse drugs, at least not in ways that are too obvious, but their opinions can be used to market them—sometimes by word of mouth, but more often by quasi-academic activities, such as grand-rounds lectures, sponsored symposia, or articles in medical journals (which may be ghostwritten by hired medical writers). While pharmaceutical companies seek out high-status KOL's with impressive academic appointments, status is only one determinant of a KOL's influence. Just as important is the fact that a KOL is, at least in theory, independent. Medical audiences trusted Dr. Fox partly because he played the part of an expert so convincingly: white coat, gray hair, and a complicated lecture, delivered with authority. But they also trusted him because they had no reason not to trust him. Dr. Fox was not selling a product or pitching an idea. The very implausibility of his charade is part of what made it so persuasive. Dr. Fox appeared to be impartial.

It is not hard to see why pharmaceutical companies would like to have a Dr. Fox speaking on their behalf. Most marketers would like to have a convincing, influential, and apparently independent expert who will deliver the text that they give him. The more interesting question is: Why do so many academic physicians want to be Dr. Fox?

"It strokes your narcissism," says Erick Turner, a psychiatrist at the Oregon Health and Science University. There is the money, of course, which is no small matter. Some high-level KOL's make more money consulting for the pharmaceutical industry than they get from their academic institutions. But the real appeal of being a KOL is that of being acknowledged as important. That feeling of importance comes not so much from the pharmaceutical companies themselves, but from associating with other academic luminaries that the companies have recruited. Academic physicians talk about the experience of being a KOL the way others might talk about being admitted to a selective fraternity or an exclusive New York dance club. No longer are you standing outside the rope trying to catch the doorman's eye, waiting hungrily to be admitted. You are one of the chosen. "You get to hobnob with these mega-thought leaders and these aspiring thought leaders," Turner says. "They make you feel like you're special."

For the rest of the article go to this link:  http://chronicle.com/article/article-content/124335/

Human Rights Violations Against Workers

HUMAN RIGHTS OF WORKERS WITH INJURIES


In our current fragmented system of health care financing, adequate and accessible workers’ compensation health insurance is essential for the protection of the right to health. In the United States, state level workers’ compensation systems are the only source of health coverage for injuries on the job.

Nearly a quarter of a million workers in the state of New York become injured on the job each year. Even when injured due to employers’ negligence, they have no recourse to the courts as workers’ compensation is intended as a substitute for law suits arising from injury. In exchange, workers are supposed to have a no fault system that covers everyone expeditiously and equitably.

Instead, workers with injuries are generally forced to prove their need for health care and wage replacement benefits in a grossly unbalanced match against powerful insurance companies and lawyers. Early in the process, workers are forced to go to low quality doctors paid by insurance companies to assess whether a worker has been injured on the job. In conflict with medical ethics, these doctors, misleadingly called Independent Medical Examiners (IMEs), go to great lengths to deny claims.

Much too often, the process turns into a bureaucratic and procedural nightmare, where workers are humiliated, stigmatized and subject to investigations that violate their right to privacy. Very little of this process is shaped by objective medical review or public health considerations. Indeed, the Workers' Compensation Board is rife with unjustified delays in access to medical care and wage replacement, rejection of legitimate injuries, obstacles for non-English speakers and inadequate rates of compensation.

The strain on workers can be extremely severe. Many workers develop new mental or physical problems as a result of their experiences with the Workers' Compensation Board, for which they might never receive support. With limited resources and inability to work, these workers and their families face hunger, extreme insecurity, and a heavy burden of guilt that they are no longer providing for their families. Essentially, workers begin with sickness and injury and often end up sicker and more injured, creating a devastating impact on human dignity and well-being.

NESRI is working with workers with injuries in upstate New York to develop analysis, documentation, public education materials and a human rights report on violations of the right to health and social security in New York’s workers’ compensation system. NESRI has also trained workers with injuries in participatory human rights documentation, and in turn, they have conducted dozens of interviews of fellow workers with injuries.

NESRI: National Economic & Social Rights Initiative

http://www.nesri.org/support_nesri/index.html

Information Hidden Regarding Dead Professor and the Plague

The Plague In Chicago
Unanswered Questions
A Year After the Death of University Of Chicago Professor Malcolm Casadaban
9/13/2010

By Steve Zeltzer

Chair, California Coalition For Workers Memorial Day
lvpsf@igc.org
http://www.workersmemorialday.org/

One year ago on September 13, 2009 at the University of Chicago, Professor Malcolm Casadaban who had been working under a US government research on Bioterrorism and Prevention Grant passed away. The story of his death and the reasons behind his death are still a mystery despite the deadly contamination that he received and many questions remain unanswered as new ones now come to the fore.

Professor Casadaban had been working on a live attenuated vaccine strain of Yersinia Pestis, a strain of plague which was approved by the Centers for Disease Control and Prevention (CDC) safe for humans and for researchers in the lab that no one had died from it. CDC and Researchers called it a vaccine strain (live-attenuated vaccine strain) and excluded the strain from their Containment list of pathogens in 2008. Professor Casadaban had worked at the University of Chicago Department of MGCB and Committee of Virology at the University of Chicago from 1980-2009.

When the family came to Chicago for the funeral, a family member requested the Hospital autopsy team to investigate and later identified that Yersinia Pestis, its live-attenuated vaccine strain, KIM D27, had been the actual cause of death. University of Chicago is a power house of Infectious Disease Experts and is the Center of Excellence in federal Grant support for bioterrorism, ironically, nothing appeared to these experts that Yersinia Pestis and its live attenuated Strain of KIM D27can be dangerous to the lab researchers and public at large. No one from the University and the Center of Research attended him while he was sick. No one warned the University of Chicago Hospital Emergency Room doctors to treat him for the dangerous pathogen which can be acquired from work. Furthermore, upon his death, no one from the University and its Institutions even suspected Yersinia Pestis pathogen to be the cause of death. Once Yersinia Septicemia on the live-attenuated vaccine strain had been identified to be the cause of death, 20 people made up of the investigational team from CDC, OSHA and Chicago Public Health (CPH) as well as from University of Chicago visited the site in the investigation of his death. Still today, one year later, CDC, CPH and OSHA have not released their report to the family. OSHA issued a letter of BSL2 compliance though no specific details on their approval were substantiated in their claim.

NIH which supported the federal research activities of Professor Casadaban and that of the Center of Excellence Grants had not even began their investigation of the case regarding serious concerns and issues relating to the health and safety conditions of the laboratories at the University and nationwide laboratories. The containment and biosafety rules regarding pathogenic bacteria in public health and safety should be investigated, seriously evaluated and explored particularly on the eve of the death of Professor Casadaban.

The issue of health and safety protection for biotech workers is not only critical for biotech workers but the public at large. In the cases of molecular biologist Becky McClain at the Grotton, CT Pfizer facility and David Bell at AgraQuest in Davis California all have experienced the failure of proper health and safety protection and oversight of these laboratories by OSHA.

http://www.councilforresponsiblegenetics.org/blog/post/CRG-ISSUES-NEW-REPORT-WORKER-SAFETY-IN-BIOLOGICAL-LABORATORIES.aspx

The California Coalition For Workers Memorial Day CCWMD believes that the unanswered questions on the death of Professor Malcolm Casadaban should be answered not only for the peace of his family but for the public at large and regardless of the power and connections of institutions like the University of Chicago and the CDC as well as OSHA the facts on this case must come out.

Background Links:

http://www.newscientist.com/blogs/shortsharpscience/2009/09/mystery-surrounds-plague-death.html?DCMP=NLC-nletter&nsref=blog

http://cbs2chicago.com/local/The.University.of.2.1195038.html

http://www.nytimes.com/2009/09/22/us/22chicago.html?_r=2&scp=1&sq=Researcher Had Bacteria For Plague At His Death &st=cse

http://obambi.wordpress.com/2009/11/15/who-killed-malcolm-casadaban-and-why/

YouTube - another dead microbiologist: chicago family seeks answers in scientist's death by plague


http://www.youtube.com/watch?v=8rJpSEqDxD4&feature=player_embedded

Saturday, September 11, 2010

Worker Safety in Biological Laboratories Is Lacking

The Council for Responsible Genetics has provided a superb overview of the harzards and lack of regulations covering the biotech industry.  See thier summary statment and link below for the full report.

Why would Pfizer, the world’s largest drug company, so mistreat and silence one of their top molecular biologists that a federal jury in Connecticut recently awarded her $1.37 million in damages? The answer promises to tear open the curtain covering hazards confronting tens of thousands of scientists and assistants in corporate, government and university labs. Becky McClain’s lawsuit against Pfizer claimed that the company’s sloppiness exposed her to an engineered form of the lentivirus, a virus related to one that could lead to immune deficiencies. It documented the absence of any available risk assessments and exposed the cruel refusal to give afflicted employees their own exposure records on the grounds that they are company trade secrets. Pfizer denied connections between its lab practices and Ms. McClain’s reoccurring paralysis and other illnesses. Becky McClain is not alone. As a revolution in genetic and other biological sciences has greatly expanded the number of laboratories in the past twenty years, workers in the biological industries have suffered from health and safety regulations that have fallen well behind the times. David Michaels, the head of OSHA, has admitted that there are “many gaps” in his agency’s standards. “New biological materials, nanomaterials, there are many things where we don’t have adequate information” (NY Times interview).


The Council for Responsible Genetics is mobilizing an effort to ensure that worker health and safety are once again protected in the United States by identifying hazards, educating the public and policy makers and working towards the creation of enforceable and openly accessible standards and practices for biological laboratories. Our new report represents an important step in this process as it lays out the current regulatory framework for commercial and academic biotechnology laboratories in the United States, identifies specific gaps in these regulations and offers some initial recommendations for improvements.

The full report can be accessed on the CRG website.

http://www.councilforresponsiblegenetics.org/pageDocuments/J118SCXSUR.pdf

Problems in Connecticut Workers Compensation

Serious problems and abuses against employees still exist in Workers Compensation for workers who sustain a work-place injury or illness.  Here is a historical perspective from 1993 in Connecticut.  It contains poignant stories related to lack of rights for injured workers.


http://www.rellsmells.com/1993%20Employee%20Testimony%20Madden.html

Friday, September 10, 2010

STAND UP FOR CANCER ...AND THEN FALL DOWN

Before you sit down and write your check to the “Stand up to Cancer” initiative, think about this…Cancer research is already supported by BILLIONS of tax dollars every year. The National Cancer Institute alone gets over $5 Billion dollars a year from your and my pockets. Are you saying “WOW”, yet?

And at the same time, when the academic, biomedical industry and pharmaceutical industry continuously push for more expensive high tech solutions to cure disease, they do not advocate the important steps to prevent disease. These industries do not support effective healthcare reforms that can save lives and prevent cancer. They have allowed our environmental laws to slacken which increases the rate of cancer. They promote dangerous high tech biological research in this country without any safety oversight to ensure public health and safety. They even block the public’s right to have their food labeled “genetically engineered” or “not genetically engineered”. They advocate for big business while ignoring public health and safety.

The money you give to charities should be directed in a way that will make a difference. Stop giving your hard earned money to these so called “sympathy-driven” large fund raising schemes or to wealthy large non-profit organizations or to biomedical institutions that continuously promote high tech solutions but ignore common sense solutions and public’s right to know. If the cancer biomedical community cannot perform adequate research with the BILLIONS of dollars they now receive from public coffers every year, then it is very unlikely another billion out of our generosity will make a difference.

If you want to give money to a good cause toward cancer cures, how about supporting grassroots organizations that want to fix our failed medical system, increase environmental protection and place safe controls on dangerous biological research? Wouldn’t that make more sense in an effort to prevent and stop cancer? Give your money to agencies that will make a difference. Don’t “Stand up to Cancer, and then fall down.

Tuesday, September 7, 2010

Tax Breaks for the “ Contingency” Attorney


There has been some recent talk of providing tax write-off for plaintiff’s attorneys who work on contingency. That is, these attorneys have to front the legal cost for a plaintiff. The AMA and other physician groups have made big opposition to this proposed legislation.

But tax breaks for plaintiff attorneys who work on contingency are much needed.

The issue at hand is that the plaintiff (who alleges to have been harmed in some way) is usually an “average” individual who has to fight a legal battle against a large corporate entity…corporation, hospital, insurance industry, etc. The large corporate entity (the defendant) has disproportionately larger sums of money and other legal resources at their disposal to fight the legal battle.

Having more money makes a HUGE difference in the outcome of litigation. The more money you have, the better your chances of winning. Period.

This monetary disparity between an average individual and a large corporate entity makes the legal system unfair. It places the plaintiff along with their contingency attorney at a disadvantage to win their lawsuit even if they have a good solid case.

Many good and well deserving plaintiff cases lose just because there is not enough money to battle a big corporation or a big hospital.

Sadly, many well-deserving plaintiffs cannot get legal representation because they cannot find an attorney who will take their case on a contingency against a big powerful entity. It involves too much financial risk for an attorney.

In addition contingency attorneys are at a disadvantage because of ways corporations can unethically draw out the legal process making the procedure too expensive for a plaintiff attorney. They squeeze the attorney to financial death.

We need to normalize the disparity of monetary power between plaintiff and defendant to make our justice system work fairly and be ethical. It is in the public’s interest to do so.

Therefore, giving tax breaks to contingency attorneys who take cases against corporate entities is good idea. It will not solve this serious problem, but it will help better balance the monetary disparity that unfortunately erodes the justice system today.

Genetically Engineered Salmon Is Going to Market_FDA calls it safe_Public has no rights

A genetically engineered (GE) salmon which grows twice as fast as natural salmon claims to be safe by FDA.    Many critics questions the validity of the study and the conflict of interests within the FDA.

This GE salmon will be the first animal approved to be eaten as food.  Unfortunately, the American people still do not have rights to have their food properly labeled as GE or not. 

The GE salmon have been modified with the addition of two genes:  one is linked to the production of growth hormone and the other it to ensure continued growth through cold temperatures.  The picture of the two salmon denotes the difference between large GE salmon and its natural counterpart which is the same age.

Critics also are frightened that these GE fish could escape into the environment causing havoc for natural salmon.  Containment of animals and organism can be problematic.  Remember the killer bees?

http://www.indybay.org/newsitems/2010/09/03/18657545.php

http://www.telegraph.co.uk/foodanddrink/foodanddrinknews/7983700/Fast-growing-GM-salmon-safe-to-be-farmed-and-eaten.html

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf

http://the-pathogen.livejournal.com/485318.html

See this recent updated post by CRG entitiled "Fishy business at the FDA".
http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=289

Saturday, September 4, 2010

Fairness in Scientific Funding_The Embryonic Stem cell versus Adult Stem Cell

Adult vs. Embryonic
Two scientists working in adult stem cell research have filed a lawsuit regarding unfair scientific funding practices which places their research at a disadvantage.  They assert that their research using adult stem cells is disadvantaged at obtaining federal funding because of disproportionate and illegal funding toward embryonic stem cell research.  Last month a judge agreed with their evidence and subsequently halted public funding of embryonic stem cell research as the legal process continues.

Below is a WSJ article which diverts the main issue of the lawsuit and instead emphasizes the moral objections toward using human embryos in embryonic stem cell research.  Nevertheless, it provides some additional information.

Stem-Cell Plaintiffs Cite Ethical Motivation
Scientists Behind Suit Say Work Using Material Derived From Embryos Is Morally Objectionable, Unlikely to Yield Cures
 
Post from WSJ Sept 2, 2010
By LAURA MECKLER and JANET ADAMY


WASHINGTON—The two scientists behind the lawsuit that has temporarily blocked federal funding for embryonic stem-cell research said Wednesday they were motivated by ethical objections to destroying human embryos for medical research.

The scientists, James Sherley of Boston and Theresa Deisher of Seattle, had never met until this week, when they flew to Washington to confer with House and Senate aides and lobby against research using embryonic stem cells. They were recruited separately by lawyers looking to challenge the federal policy.
"We have a responsibility and are taught to do ethical research," said Dr. Sherley in an interview with The Wall Street Journal. "This is impacting the quality of science in this country."

Embryonic stem-cell research is seen as promising by many scientists to treat a range of diseases because the cells can develop into any type of tissue. But to get the cells, the embryo must be destroyed, which some see as akin to taking a human life. The embryos used are typically left over from fertility treatments.
 
A federal judge last week ruled the research violated federal law. The decision rocked the scientific community while bolstering social conservatives, who have long argued the experiments are immoral.


The Obama administration is appealing the judge's order, and said this week it would require the government to stop funding all embryonic stem-cell research, including that allowed under more-restrictive rules set by the Bush administration.

The scientists bring similar points of view to the issue. Dr. Deisher is Catholic and wears a small gold cross, while Dr. Sherley is Baptist, but both say their views on the matter are driven by ethics, not religion.

Both have been in the news before. Dr. Sherley, 52 years old, staged a 12-day hunger strike in 2007 after the Massachusetts Institute of Technology denied him tenure. Dr. Sherley, who is black, blamed racism for the rejection, a charge the school denied.


Dr. Deisher, 47, has spoken at antiabortion events and gained attention when she accused a former employer of fraud, a charge that led to a Securities and Exchange Commission investigation.

She said she was transformed from a "radical feminist" after she saw the negative impact abortion had on some of her friends.

Both said embryonic stem-cell research is morally objectionable and unlikely to produce promised treatments or cures. They said research using adult stem cells, the field each of them works in, has more potential to help patients.

The public has "been sold this hype and this promise that embryonic stem cells are going to cure everyone and we're all going to get up and dance," Dr. Deisher said. But she said researchers involved always wind up reneging on their promises.

Those on the other side say it is up to scientific panels convened by the National Institutes of Health to decide what is most promising.

"These guys are using a court process in what should be a scientific process," said Curt I. Civin, director of the University of Maryland's stem-cell biology center.

Their case relies on their contention that they are disadvantaged in their effort to get federal research dollars because of illegal competition from embryonic stem-cell researchers. In its legal filing, the Obama administration noted that Dr. Deisher had never even applied for government research funding.

She said that doesn't matter.

"Any adult stem cell scientist is disadvantaged, and that's because there is a deliberate focus to fund embryonic stem cell research and a focus away from adult stem cell research," Dr. Deisher said.

An appeals court has already said the two scientists were entitled to sue.

The scientists and their lawyer, Samuel Casey, said they were surprised by the sweeping impact of federal Judge Royce Lamberth's decision. Mr. Casey said he hadn't asked the court to address Bush-era rules or anticipated a ruling that would halt research funded under those rules.

Though the appeals process has just begun, Drs. Sherley and Deisher started canvassing Capitol Hill this week, anticipating the matter ultimately may be decided by Congress. They said they spent Wednesday meeting with Senate and House aides to make the case against the research.

Some lawmakers have talked of passing new legislation to nullify Judge Lamberth's ruling and clarify that stem-cell research derived from embryos is allowed. Congress passed such a measure most recently in 2007 but it was vetoed by then-President George W. Bush.

Drs. Sherley and Deisher said they were talking with congressional aides about why reviving the legislation would be a mistake.