Workers Compensation Causing Desperate Acts

"More Desperate Acts From Desperate People"

By David J. DePaolo

posted on 4/24/2010

David J. DePaolo is the president and CEO of WorkCompCentral.com, a web based subscription newsite that deals with eveything Workers Compensation in California. David is also an attorney, and has been a member of the California Bar since 1985. He is a graduate of the Pepperdine University School of Law.

Yesterday (May 20) was quite the trying day. First the news comes out that professional cyclist and dethroned Tour de France winner Floyd Landis not only admits to doping, but accuses everyone else in cycling, from American hero Lance Armstrong, to the world executives in charge of professional cycling, to either doping or knowingly turning a blind eye.

Just as I recovered from these dark revelations I get an urgent e-mail mid-afternoon from a close friend that an attorney had just been stabbed at the Los Angeles District Office of the Workers’ Compensation Appeals Board. Like the Landis news, I was disheartened by this news, but certainly not surprised.

As we later reported, allegedly 38 year-old Andre Torres stabbed 60 year-old attorney Joe Rippinger in the back with a 9-inch kitchen knife. Details at the time I write this are unknown, but reports are that Torres and Rippinger did not have any relationship at all – apparently Rippinger was at the wrong place at the wrong time as Torres was intent on taking out his rage on an attorney – any attorney.

We can only surmise, but my guess is that Torres if he is the culprit has deep emotional scars from getting lost in the jungle of Workers’ Compensation.

I see evidence of this all the time, as I’m sure many in the industry do – desperate people fed up with the “system” act out in different ways – many of these desperate people vent their anger and rage in our forums, sometimes they send me e-mails or letters documenting their frustration with the system and desperation to get better, and sometimes they just commit suicide because there no longer is any hope.

Workers’ Compensation has seen its share of violence from such folk – Santa Cruz attorney Jay Bloombecker murdered in 2006 by a client, SCIF attorney Louise Armstrong assaulted in a parking lot in Anaheim, defense attorney Erwin Nepomuceno beaten with a hammer by an upset applicant in front of a medical clinic.

It would be easy to blame the Division of Workers’ Compensation for not setting tighter security protocol such as metal detectors, but the issue is not just one of security.

And it would be easy to just blame the injured worker and assume that these are just crazy people who would act out in some manner regardless, and just happened to choose a workers’ compensation situation due to convenience.
But I don’t think that the blame is so easy to assign, and I think the blame goes to the heart of what is fundamentally wrong with workers’ compensation: the one person whom the system is to benefit, the one person who is in the system involuntarily, is the one person who has no control over his or her fate – people pushed to the brink of sanity and then acting out in a violent, desperate manner in an attempt to get some relief.
Think about that – once the injured worker ends up in litigation nearly all semblance of control over his or her destiny is taken away, from being told what doctor to see, what treatment can or can not be approved, the expiration of disability payments, whether he or she can go to work, etc. The injured worker has no say during the life of the litigated claim until it’s settlement time.

The litigation process in California Workers’ Compensation is designed to remove all responsibility from the injured worker, and ergo, remove all control from the injured worker. This may not be the intent of the process, but it is the result.
Medical control essentially rests with the employer. This modification to the system was necessary, as are most rules and regulations, because a few bad apples decided to abuse the right to medical to control so that they could unfairly profit from the system.

And not only has the right to medical control been usurped, the method of contesting medical decisions has been removed from the injured worker’s control – it’s in the hands of utilization reviewers with essentially no right of appeal.

If you’re lucky enough to get to a hearing about a disagreement or conflict with the case, it’s likely months before any decision is made (which again is out of the hands of the injured worker) and it is very likely that the claims administrator may still not abide by the ruling, further delaying the claim and the fate of the injured worker.

The injured worker cannot get back to work because the employer doesn’t want a broken employee. The physician will prescribe a permanent impairment assessment, but the injured worker has no understanding of what that fiction means, or what its ultimate relation to a settlement is.

While all of this professional activity is going on around the injured worker, months or years go by and the injured worker has been off work for so long that there isn’t any motivation as he or she spirals down into depression.

This is no excuse for acting out or the violence that has made recent headlines. It is an indictment of the “system” – a process that is so complex, so entrenched, so lacking of humanity, that it no longer does what it was supposed to do: provide protection for the injured worker so he or she can get back to work.

Somewhere, at some time, some one with political power and clout will figure out that the problem with Workers’ Compensation is Workers’ Compensation itself – the system no longer serves the only involuntary participant. When that happens the system will cease, an industry will shift to another profit source, and perhaps the injured worker will regain some control over his or her life. Until then, expect more desperate acts from desperate people.

Lack of Enforcement against Drug Industry Fraud



Pharmaecutical companies use fraud
because it makes money
 and there is little punishment



Excerpts from: 

Drug Industry Fraud

By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety?

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He stated: "unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

For entire article see:
http://www.counterpunch.org/nader12282010.html

Diseases of the Nails_Slide Show

Diseases of the Nails_Slide Show
http://www.medscape.com/features/slideshow/nail-diseases?src=nl_slide

Which Rashes to Worry About_Slide Show

Which Rashes to Worry About
http://www.medscape.com/features/slideshow/rashes?src=nl_slide

Common Rashes Not to Miss_Slideshow



Common Rashes Not to Miss:  Slide Show
http://www.medscape.com/features/slideshow/common-rashes?src=nl_slide



Worker's Compensation and Depraved Indifference

Hear this interesting Podcast on Worker's Compensation Problems by Dr. Patrice Woeppel, author of  "Depraved Indifference". http://www.ciws.ca/WCM_061209_Woeppel.mp3


Please see this video also:  http://www.blip.tv/file/4383774

Monsanto Patent Rights Destroy Farmer's Rights

Percy and Louise Schmeiser were sued by Monsanto after Monsanto's genetically engineered canola seed contaminated the Schmeiser's farm crops.  Despite the fact that Monsanto did not contain their invention, the law declared that patent rights supersede farmers' rights.  The Schmeisers had to destroy their own seeds which they had developed over 50 years because of Monsanto's contamination into their fields. 

Farmers are the losers in this legal battle as the law bends toward corporate control, making it more and more difficult for individual farmers to own their own seeds or plants.

Safety Concerns On Genetically Modified Mosquitoes To Be Released

GE Mosquitoes Soon to be Released in Malaysia, Many Unanswered Questions Remain

Malaysia is on the brink of field testing GE mosquitoes in a small town in the

state of Pahang, a short distance from Kuala Lumpur. Preparations are said to be

underway to release the GE mosquitoes, first, in an uninhabited area and

subsequently, in an inhabited area. Another proposed site for the field

experiment is in the state of Melaka.



This is despite an outpouring of concern by scientists, civil society

organizations, local inhabitants and individuals who have expressed their

reservations with regard to the health and environmental effects of this

untested GE organism. Furthermore, the lack of transparency with regards the

manner in which the process of field testing is conducted is also an issue of

concern. As of date it is unclear if the inhabitants of the proposed site have

given their consent, which is required under the terms and condition for the

release.



Under the field trial, genetically engineered male Aedes aegypti mosquitoes

(OX513A) will be released and studied and if the experiment is successful, the

GE mosquitoes may later be used as part of a programme to curb dengue in

Malaysia, a disease which is currently rampant in the country. The GE mosquitoes

are genetically engineered to include two new traits: fluorescence and

conditional lethality. The fluorescence trait acts as a marker for the GE

mosquitoes. When the GE male mosquitoes mate with females in the wild, the

conditional lethality trait will be passed on to the offspring and the resulting

mosquito larvae will die, provided this happens in the absence of the antibiotic

tetracycline.



The GE mosquitoes is a product of Oxitec, a biotech company based in the UK. The

company will be working with the Malaysian Institute of Medical Research whose

application to conduct the field trial was approved by the National Biosafety

Board. Oxitec had conducted its first experimental study using the same OX513A

strain of Aedes aegypti in the Cayman Islands. However, experts have doubts as

to the sustainability of the initiative and have called for a full, long-term

assessment of the Cayman trials, especially to identify any unintended effects,

before consideration of release anywhere else in the world.



As Malaysia prepares to embark on a similar venture, many other questions about

the GE mosquitoes remained unanswered. These include: Will the GE male

mosquitoes actually be able to mate with the female wild mosquitoes outside a

controlled environment? How certain it is that the GE mosquitoes will not cause

a new disease in the future or acquire the ability to transmit other diseases?

Who will take responsibility in the event untoward effects happen as a result of

the experiment?



Given the uncertainties and concerns relating to the technology, health,

environment and so forth, many have called for a rethink of the project and

suggested that other less risky methods of dengue control be considered and

stepped up.


Third World Network
131 Jalan Macalister,
10400 Penang,
Malaysia
Email: twnet@po.jaring.my
Website: www.biosafety-info.net and http://www.twnside.org.sg/

TWN Biosafety Info

Title : GE Mosquitoes Soon to be Released in Malaysia
Date : 13 December 2010

Whistleblowers Get Bad Deal

Senate Passes S.372: A Bad Deal for Whistleblowers

Posted on December 12, 2010 by Lindsey Williams

http://www.whistleblowersblog.org/

On December 10, 2010, the Senate passed the Whistleblower Protection Enhancement Act (S. 372) by unanimous consent. After a careful review of S. 372, the National Whistleblowers Center, the Federal Ethics Center, and the National Security Whistleblowers Coalition strongly recommend that the bill not be approved in its current form. We urge the House of Representatives to fix the bill and send it back to the Senate for final approval. Here is why the bill must be fixed:

1. New Summary Dismissal Authority. The bill gives the Merit Systems Protection Board (MSPB) sweeping new powers to dismiss whistleblower claims without a hearing. The MSPB Administrative Judges will now be able to dismiss WPA claims without a hearing, based solely on affidavits filed by executive agencies. If whistleblowers did not conduct extensive and expensive pre-trial depositions, they will be unable to rebut these affidavits, and their cases will be dismissed. Even if the whistleblower is able to afford the significant additional fees and costs caused by the new summary dismissal proceedings, based on the track record of the AJs, the vast majority of cases will be summarily dismissed based on agency affidavits. The opportunity to create a record at a hearing, or use the pre-hearing process as an opportunity to reach a settlement, will be lost. This is a significant rollback of current rights that will make it more costly and more difficult for whistleblowers to prevail in any actions, despite any of the other reforms contained in the legislation.

Continue Reading...

Tags: HR 1507, Legislation, S. 372, Senate, Whistleblower Protection Enhancement Act, whistleblower laws

Deadly Mystery Illness in Uganda

A new mysterious disease has killed 38 people so far in Uganda during a month's time.  The victims are all males.  They have suffered from fever, severe headaches, dizziness, diarrhoea and vomiting.  Authorities have yet been able to identify the causative agent.  Some speculate that it could be a possible resurgence of an epidemic of bubonic plague or a new emerging disease.

http://www.africanews.com/site/Uganda_Mysterious_disease_kills_38/list_messages/36560

Inner working of cell

http://articles.mercola.com/sites/articles/archive/2010/12/01/amazing-video-animation-of-the-inner-life-of-a-cell.aspx

See interesting animation of inner workings of cell.

Risks of Human Embryonic Stem Cell Clinical Trials for Spinal Cord Injury

Patients must use caution when considering enrolling in Geron’s embryonic stem cell clinical trial for spinal chord injury. This is the first human clinical trial of its kind. The trial is designed exclusively to provide  for safety information and not efficacy.

I am especially concerned for the protection of the patients who enroll in this trial. The reason being is that this trial holds high risks to the patient. Most of the public is not aware of the risks and limitations of embryonic stem cell research.

Geron has designed their initial safety trial to only enroll patients with recent non-severed spinal chord injuries. These injuries are designated as crushing or contusion spinal chord injuries. Geron will be monitoring the outcome of the trial by if a patient can gain some improvement such as the ability to “wiggle their toes” days or months subsequent to the treatment.

Geron didn’t pick this group of patients without considerable forethought to promote their product. In fact, this population of patients is the most likely spinal chord injury population that would make Geron’s drug look good, when indeed it may not be good at all. The reason being is that since the patient’s spinal chords have not been severed, these patients have a marked probability of recovering from these injuries to various degrees without embryonic stem cell treatment.

Consequently, a “wiggle toe” outcome in Geron’s trial will not project any conclusive data toward determining the efficacy of Geron’s embryonic stem cell drug.  (Although I can reasonably predict and would actually gamble on the fact, that when the first treated patient wiggles his toes, the scientific propaganda machine will undoubtedly tout it as an embryonic stem cell miracle cure to the unsuspecting population. I can see a picture of the toes wiggling in the newspapers already.)

And although the sight of someone wiggling their toes after incurring such a horrific injury to their spinal chord brings joyous emotions to anyone with an ounce of empathy for their suffering, the patient receiving the embryonic stem cell treatment is not home free. They took a risk when entering this trial. A big risk.

One of the major risks involves a cellular process called differentiation. Differentiation is a complex process within embryogenesis that makes an embryonic stem cell “morph” into individual adult cells, all with different roles and purposes in an amazingly well orchestrated fashion. As scientists, we have limited understanding of this process.

So when a scientist attempts to “differentiate” an embryonic stem cell in a tissue culture dish instead, the process is not perfect. And what may "look" like a differentiated neuron to our limited understanding as scientists…may actually not be a neuron. In fact, it may be a “wolf in sheep’s clothing”. And when implanted into a patient, it could cause devastating results.

The RISK to the patient is incredibly high in undergoing this embryonic stem cell treatment. And the Geron trial is no exception.

Even if the treated patient “wiggles his toes” after receiving the embryonic stem cell treatment, he may very well succumb to a teratoma or auto immune disorder years later. These risks are real and they are well documented in animal studies in the scientific literature regarding embryonic stem cell therapies.

I do hope that these spinal chord injury patients who will be in the unfortunate position to consider entering into Geron’s human embryonic stem cell clinical trial will receive thorough counseling prior to giving consent. One can only imagine that the patient considering this option is DESPERATE at the time of injury since he is paralyzed, albeit perhaps only temporarily.

I would highly advice those families who have a loved one who is considering entering this trial to seek both objective and independent scientific and legal counsel before signing any consent form. Make sure you understand every sentence in the consent contract…even the small print. Make sure that the experts you choose to counsel with have no conflicts of interest with the Geron trial, which unfortunately is sometimes hard to determine.

Keep in mind that this is a SAFETY trial and not an efficacy trial. That is, it has been designed to look at the SAFETY of the product and not for a cure.

Geron’s human embryonic stem cell is a dangerous trial, the safety outcome of which is not only measured within the initial months but decades later.

If you have any questions, contact me at watchdogonscience@comcast.net.

Watchdogonscience


http://watchdogonscience.blogspot.com/2009/02/dangers-with-embryonic-stem-cell.html
http://www.boston.com/news/nation/washington/articles/2010/10/12/spinal_cord_patient_gets_first_embryonic_stem_cell_treatment/

Veteran’s Day

November 11, 2011

WatchDogOnScience gives thanks to all Veterans for their sacrifice.

Peace on Earth.

Fact or Fiction? Nevertheless...Very Very Strange Videos

Here are some very strange videos of animals.  Are these contrived videos? It is difficult to imagine that these are real.

New Bizarre animal discovered in Japan:

http://www.youtube.com/watch?v=_oPxa3C3iu0&NR=1

Strange Creature in Panama
http://www.youtube.com/watch?v=wBRWrDshfEM&feature=related

Real Chimera Manticore
http://www.youtube.com/watch?v=utX4kLhdwpM&NR=1

What country is this from?
http://www.youtube.com/watch?v=OZswjgbugts&feature=related

Montauk Monster
http://www.youtube.com/watch?v=H3msfUn16XY&NR=1
http://www.break.com/usercontent/2008/7/Montauk-Monster-547031.html
http://www.youtube.com/watch?v=8hKXeHvmPDc
http://www.youtube.com/watch?v=NwhdaW4wPeQ&NR=1
http://video.foxnews.com/v/3930500/return-of-the-montauk-monster
http://www.youtube.com/watch?v=b0qdnfTWi7I&NR=1&feature=fvwp

Induced Pluripotent Stem Cells Background

Human Robots

http://futurisms.thenewatlantis.com/

IVF More Dangerous Than It Appears

IVF could more than double the risk of a child developing cerebral palsy.  http://www.bioedge.org/index.php/bioethics/bioethics_article/9280/

IVF clinics can make mistakes and may produce babies that are not fro expected parents. http://www.bioedge.org/index.php/bioethics/bioethics_article/9281/

Civil Liberties versus Patent Rights

http://multivu.prnewswire.com/mnr/aclu/38183/

Human Rights Go Wrong in Worker's Compensation_Depraved Indifference

Patrice Woeppel On "Depraved Indifference: the Workers' Compensation System"



http://www.blip.tv/file/4383774
Patrice Woeppel, author of ;"Depraved Indifference: the Workers' Compensation System"

talks about the systemic crisis and failure of the workers comp system which punishes

workers while harming injured workers. This interview was done on October 14, 2010.

For more information go to: www.patricewoeppel.us

Production of Labor Video Project laborvideo.blip.tv www.laborvideo.org

Lawmakers and Enforcers Ignore Dangerous Biotech

http://www.docstoc.com/docs/58157797/Hold-US-Attorney-Eric-Holder-Responsible-Prosecute-Pam-Marrone-Liberty-Mutual-Says-Sandi-Trend

OSHA Pro Corporate_Dr. Larry Rose

Search for doctors with conflicts of interest

A "Docs on Pharma Payroll" Database has been initiated by ProPublica.  It includes a 2009 list of all doctors who have received monetary benefits from Eli Lily, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, J&J and Cephalon.  The total contributions to physicians for 2009 from all seven companies equaled oever $240 million.  Wow.

Here is the link to search for a specific doctor and or drug company:  http://projects.propublica.org/docdollars/

Patents and Genes

Judge Invalidates Human Gene Patent
http://www.nytimes.com/2010/03/30/business/30gene.html?ref=business

Public Denied Right to Have GMO Food Labeling Standards

http://www.youtube.com/watch?v=qr7ceclikEw

Politics, Power and the Control of our Food Supply

Mysteriously Acquired Lung Illness

At Least 36 Attending Lung Association Event at Iowa Governor's Mansion Get Rare Lung Disease

Published by Associated Press on Monday, March 31, 2008

DES MOINES, Iowa — After months of investigating, state health officials are confident a mysterious outbreak of a rare lung disease has its roots at the governor's mansion.


But they still don't have proof and other questions remain about how people were exposed to the disease at Terrace Hill.

State Epidemiologist Patricia Quinlisk says health officials are still awaiting test results to pin down the source of the histoplasmosis, an unusual but treatable lung disease.

The outbreak emerged more than four months ago when doctors began reporting cases. Eventually, there would be 36 confirmed cases and 12 probable ones.

Hundreds of pages of e-mails, correspondence and other documents obtained by The Associated Press under Iowa's freedom of information law, as well as interviews with health officials, show a methodical inquiry into the outbreak. The investigation led to the 139-year-old governor's mansion just west of downtown Des Moines.

Polk County doctors began reporting the disease, caused by an airborne fungi from bird or bat droppings, soon after the New Year's holiday.

Health officials worked to narrow the potential locations and connecting factors to the outbreak and determined many of those affected had attended an American Lung Association event at Terrace Hill on November 29th.

Officials say there was some construction at Terrace Hill around the time of the event and that might have been enough of a disturbance to put the offending spores in the air.

Governor Chet Culver and his wife, Mari Culver, were tested and do not have the illness.

http://www.foxnews.com/story/0,2933,343508,00.html

History of "Right to Know And What That Means Today for Biotech Workers" by Dan Berman

Daniel Berman On Pfizer Molecular Biologist Becky McClain Case

 http://blip.tv/file/3604696

Daniel Berman, author of "Death On The Job" talked about the case of injured Pfizer
molecular biologist Becky McClain on April 27, 2010 in Sacramento. McClain was
doing stem cell research and was contaminated as a result of the lack of proper
health and safety protection at the Groton CT. Pfizer laboratories.

Washington Post Stein_Irresponsible Reporting on Human Embryonic Stem Cell Trial

The Washington Post published an embarrassing article entitled the "First patient treated in stem cell study" by Rob Stein on October 11, 2010.  The study that Stein's article refers to is the first human clinical trial performed using human embryonic stem cells to treat recent spinal chord injury in the United States.  Stein writes, "Doctors will, however, also conduct a series of specially designed tests to see whether the treatment helps the patients." 

Stein has it WRONG....dead wrong.  This study is designed only as a SAFETY study.  The results of this study cannot begin to access if the actual embryonic stem cell treatment helped or not.  Scientifically...it isn't possible.

Any suggestion that this study can provide insight into assesssing whether the treatment helped the patient is utterly irresponsible.

In fact, this clinical trial does not even have the proper scientific controls to access benefits of the treatment.  It can only provide information if it is SAFE or NOT.  Period.

One of the problems is the patient selection criteria.   Many skeptics were questioning why the human subjects for this trial were only selected from the recently injured, instead of from a population who had experienced more long term spinal injuries which no longer benefited from physical therapy.  Since many recent spinal chord injured patients have been found to improve slowly over time with only physical therapy, using only recently injured patients makes it difficult and impossible to access treatment effectiveness.

The reason why only recently injured patients are selected is suspicious.   Proponents of the embryonic stem cell community can "twist" the results of this safety study in the media, purporting that the patient improvement was specific to the treatment, when in fact, many of these patients would improve on thier own without treatment.

And here comes Stein...doing exactly that...twisting the facts...making statements that this study can access treatment effectiveness.  It is untruthful and dishonest.

The human clinical study has been designed specifically to access the safety of the treatment.   It has not been designed to assess if the treatment is effective or not.  Reporting that this study can provide any insights on effectiveness, is plain ridiculous and reckless.

Is Stein being a scientific baffoon...or is he promoting propaganda on purpose?  Who knows.  But one thing is for sure...Stein's Washington Post article is irresponsible.   There is no excuse for this type of reporting.

The Business Behind Academic Research

Academia is in business.  The public has been sold out.

Below are two well-written articles describing how academia has left its mission toward the public's good, and instead has developed into academic-industrial complex. 



Doctor Who? By Neil Munro

http://www.washingtonmonthly.com/features/2001/0211.munro.html

The Kept University
by Eyal Press and Jennifer Washburn
http://www.theatlantic.com/past/docs/issues/2000/03/press.htm

http://www.mindfully.org/GE/The-Kept-UniversityMar00.htm

BL3 Lab Safety

A good article recently published by Gene Watch Magazine provides a insiders perspective of BL3 laboratory safety.  Here is the link:

A VIEW FROM THE INSIDE

By Nancy Connell
http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=287



Biolevel Safety 3 labs are under some regulatory control.  BL2 laboratories are not.  One could estimate that there could be at least 10,000 BL2 labs in the US,   Therefore, although BL3 labs work with dangerous select agents, BL2 labs pose more threat to the public since they are unregulated and unregistered and can cause human disease.

Biotech Workers Denied Medical Care from Exposures to Biological Agents

Sandi Trend, mother of injured biotech worker speaks out at CA Commission on Health and Safety and Workers Compensation.  Injuries to Biotech workers are being discounted due to little regulation and oversight in the field.  Biotech workers are even denied exposure records necessary for medical treatment.  Corporations "game" the system and deny injury since they know that biotech workers cannot "prove" that their exposure caused their illness since they are denied exposure records.  Worker's who are desperately ill must go on social security or medicare.  The cost shifts to the public instead of the profit-driven corporation.

It is the same old story.  The public loses.  The corporations win.

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.

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

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

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/

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

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