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Week Ending: April 18, 2009
Alan Franciscus
Editor-in-Chief
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This Issue:
April 13, 2009
Editorial: Addiction Behind Bars
http://www.nytimes.com
Andrew Rosenthal
The United States must do more to curb the spread of diseases like AIDS and hepatitis C in prison, where infection rates are high and inmates can easily spread disease through unprotected sex or by sharing needles.
Drug treatment in prison is clearly part of the solution. But by some estimates, fewer than one in five inmates who need formal treatment are actually getting it. That’s alarming, given that about half the prison population suffers from drug abuse or dependency problems.
Addicted prisoners cause problems outside the walls. After they’re freed, addicts with H.I.V. or AIDS can infect spouses and lovers. They feed their addictions by returning to crime, which lands them back in prison and starts the terrible cycle over again.
The most effective programs provide inmates with high-quality treatment in prison and continue that treatment when prisoners return to their communities. Such programs have been shown to reduce both drug use and recidivism.
But good programs are rare, according to a report earlier this year in The Journal of the American Medical Association. Prisons typically rely on the abstinence-only model, which fails miserably with heroin addicts. Moreover, prison officials are notoriously hostile to methadone maintenance and other chemically based therapies that have long been a standard for people addicted to opiates.
Prison treatment is particularly disastrous in New York, according to a new report from Human Rights Watch. Imprisoned addicts, the authors say, are typically shut out of treatment until their sentences are nearly over because of ill-conceived policies that give priority to those who are about to be released.
New rules created earlier this month should help address these problems. The rules give oversight responsibility for prison treatment programs to the State Office of Alcoholism and Substance Abuse Services, an agency that develops treatment programs and licenses treatment providers.
The agency will be required to make sure that prison drug treatments are tailored to inmates’ needs. It will also monitor the programs, filing annual reports to the governor and Legislature. Drug-policy advocates hope that the new arrangement will improve treatment and provide timely help for addicted inmates. That would be good for public health. It could reduce crime, too.
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Newark program trades clean needles with 600 addicts
http://www.nj.com
by Carmen Juri/The Star-Ledger
Every week in Newark, 2,500 clean needles are handed out and 2,500 dirty needles are taken off the streets -- one needle at a time.
This year's needle exchange could result in stopping the use and circulation of more than 130,000 needles possibly infected with HIV or hepatitis C, program officials say. As a result, 600 addicts who -- while still using drugs -- will hopefully not join the ranks of New Jersey's 27,000 intravenous drug users infected with HIV. In all, not a bad start to the program that politicians opposed for 13 years.
A year ago, the North Jersey Community Research Initiative began its needle exchange in Newark without a cent of state funding and in the face of critics who claimed that giving intravenous drug users clean needles was just supporting their habits.
From 78 clients a year ago, Newark now has about 600 regular clients who bring in about 500 used needles per day and leave with an equal number of clean ones, said Bob Baxter, director of addiction and education services for NJCRI.
"People think it is enabling and increasing the use of drugs. It's just the opposite," Baxter said of the exchange. "It's a public health issue. Just saying no to people who have always said yes doesn't work."
Proponents say the need is clear: of the 71,812 cases of HIV/AIDS reported in New Jersey as of June 2008, the state Department of Health and Senior Services said nearly 40 percent were contracted from IV drug use. The top reporting counties were those with inner cities, including Essex, Hudson, Passaic, Camden and Atlantic.
In 2004, the state announced intravenous drug use was responsible for 50-90 percent of all new hepatitis C cases.
Despite numerous studies that show needle exchanges reduce the risk of infections, the debate in the New Jersey Legislature raged for 13 years. Finally in December 2006, Gov. Jon Corzine signed legislation creating four needle exchange pilot operations, in Newark, Camden, Paterson and Atlantic City.
New Jersey was the last state in the nation to offer addicts access to clean needles.
Similar programs in New York, California and Pennsylvania all received public funding, but the New Jersey sites had to raise money from the private sector. Each gets less than $100,000 per year from corporations such as Proctor & Gamble, said Roseanne Scotti, director of the Drug Policy Alliance New Jersey.
"All the programs are running on a shoestring, on a wing and a prayer," said Scotti, adding she fears the current economic climate might force private donors to cut back funding.
Clients bring in their dirty needles and fill out an anonymous survey asking how many syringes they want to exchange at a rate of one clean for one dirty syringe. They are asked if they were arrested since their last visit, if there are other used needles at home, how many people they are exchanging needles for and if they are interested in services such as HIV testing, shelter or drug-abuse treatment.
After a slow start last year, the four New Jersey exchanges now have about 2,100 clients, Scotti said. The addicts also get direct access to the help they need.
"They may not want it today, but if you maintain contact they may eventually get sick and tired of being sick and tired," Baxter said, adding that 100 addicts enrolled in drug rehab since January.
Baxter said some clients pick up 100 syringes at time, while others may pick up only 20. Drug users leave with a small paper bag that contains, among other things, a container for safe disposal of their needles, tourniquets, alcohol and wipe pads, he added.
James, who asked his last name be withheld, had been using heroin and cocaine for 20 years when he first arrived at the Newark needle exchange last year. Counselors asked the 50-year-old if he would consider rehab -- the Research Initiative is also a licensed drug treatment facility -- and James accepted the offer.
James said he is now off heroin and working to get off cocaine. He also gets tested more frequently for HIV. "Once you get here, it opens up other doors for you," he said.
Another client, Danielle, 36, agreed: "They ask if you need help with detox or counseling. They don't just give you (needles) and say, 'Here, keep doing drugs.'"
It is too soon to determine the impact of the syringe program on HIV or other infectious diseases in New Jersey, but evidence from cities with long-standing programs is dramatic, Scotti said.
One study published in the American Journal of Public Health in 2005 analyzed HIV rates among intravenous drug users in New York City between 1990 and 2002, during which time the number of needles exchanged rose from 250,000 to 3 million a year. The rate of HIV infection among IV drug users dropped nearly 80 percent.
"I have seen over and over and over again the change it makes in people's lives," said Scotti, who was formerly on the board of a Philadelphia needle exchange. "It's the first day they move toward making positive change toward their life. It's a huge step."
Judy Peet contributed to this story.
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Vaccination fears over plan for Hepatitis B jabs for babies
http://www.telegraph.co.uk
By Alastair Jamieson
Babies could be routinely vaccinated against Hepatitis B in a move that could anger parents concerned about the side-effects of jabs.
Government health experts are considering whether to add the vaccine to a jab given to children at eight weeks.
The option, to be discussed by the Joint Committee on Vaccination and Immunisation in June, would create a six-in-one vaccine that would also immunise against diphtheria, tetanus, whooping cough, polio and Hib disease – a form of pneumonia.
It comes in response to rising levels in Britain of Hepatitis B, a blood infection that can lead to liver cancer.
Campaign groups said the move would worry parents already concerned that children are given too many vaccines, many of which have been linked to potentially harmful side-effects.
Children are already given 32 vaccines before they even reach school age, spread across 11 jabs including the MMR against measles, mumps and rubella once claimed to be linked to the onset of autism. The addition of the Hepatitis B immunisation to the first jab would bring the total of vaccines to 33.
A Harvard study found those vaccinated against Hepatitis B are at increased risk of multiple sclerosis, although it did not determine whether the jab caused the disease or speeded up the onset in those already destined to have it.
Jonathan Harris, of campaign group Jabs, said: "The vaccine has been linked to multiple sclerosis and Chronic Fatigue Syndrome and parents will understandably question the need to add it to what is an already crowded schedule of jabs. There will be a great deal of public concern about this and, as usual, very little consultation."
Estimates suggest the number infected by Hepatitis B in Britain almost doubled between 2002 and 2007, to 326,000. More than half of those cases were immigrants from Africa, Asia, Russia and the new EU nations.
The British Medical Association and the charity Hepatitis Foundation UK have previously called for all babies to be immunised against Hepatitis B, bringing the UK in line with World Health Organisation policy.
Andrew Wilson, a trustee of Hepatitis Foundation UK, said: "The trouble is hepatitis B is known as a silent killer because there are often no symptoms until real damage has been done. Parents' concerns are understandable but a child vaccinated at a young age will always be protected."
The virus can be spread by only a tiny amount of blood through cuts and grazes, but is most commonly transmitted by unprotected sex and needle sharing among drug addicts.
Andrew Thomson, of the BMA's Board of Science, said Hepatitis B infection rates were spiralling and that treating the infection was costing the NHS millions of pounds.
High risk areas for the disease include South Asia, Africa and parts of Eastern Europe. Many migrants from these areas settle in Britain. The condition can kill five per cent of those who contract it.
A spokeswoman for the Department of Health said: "The safety of children is always paramount whenever decisions are taken regarding what vaccines are included as part of the child vaccination programme.
"We do target hepatitis B immunisation at groups at increased risk of infection such as babies born to infected mothers, injecting drug users, those at risk of sexual exposure, and healthcare workers.
"The Joint Committee on Vaccination and Immunisation (JCVI), the independent expert advisory committee, keeps all vaccine issues under review including Hepatitis B."
From this month, the Joint Committee on Vaccination and Immunisation has greater powers to decide UK vaccine policy.
http://www.telegraph.co.uk/health/healthnews
/5145192/Vaccination-fears-over-plan-for-
Hepatitis-B-jabs-for-babies.html
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April 15, 2009
Legislation drafted for bloodwork uniformity: Hepatitis B link prompts action
http://www.app.com
By Chelsea Michels • TOMS RIVER BUREAU
TRENTON — As a result of recent cases of hepatitis B linked to a doctor's office in Ocean County, state Sen. Robert W. Singer is drafting legislation aimed at ensuring that medical practices providing intravenous cancer and blood treatments adhere to uniform procedures that prevent infection.
"There really is no oversight on a regular basis of doctors' offices, as opposed to someone who goes to a hospital," said Singer, R-Ocean, vice chairman of the Ocean County Board of Health. "We inspect places we eat once a year, and once a year each county health department should inspect doctors' offices" that provide intravenous oncology and hematology therapies.
The Ocean County Health Department said five cases of hepatitis B were reported to it and the state Department of Health and Senior Services in late February. All of the infected people were patients of Dr. Parvez Dara, an oncologist with offices in Toms River and the Whiting section of Manchester.
In late March, approximately 2,800 patients of Dara received a letter urging them to be tested for HIV, the virus that causes AIDS, hepatitis C and hepatitis B.
Last week, the state Board of Medical Examiners suspended Dara's medical license indefinitely after investigators said there was evidence of unsterile practices and procedures in his office. Dara's lawyer said the board acted on an incomplete investigation and should not have prevented him from working at Community Medical Center in Toms River or seeing patients for noninvasive treatments.
"Patients who set foot in any doctor's office in New Jersey should be able to assume that the facility is clean and the staff is well trained," Singer added in a prepared statement. "This bill helps ensure that medical facilities are operating under safe conditions with the health and well-being of the patient being the utmost priority. Most doctors are very stringent when it comes to adhering to regulatory measures and safety precautions in their medical offices. Just in case they aren't, this bill serves as another layer of public protection."
Singer's bill would require physicians who perform intravenous therapy to register with the Department of Health and Senior Services. Ocean County health officials confirmed that there are approximately 700 licensed physicians in the county, although not each one would be required to register with the state Health Department.
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Cancelled jailhouse tattoo program lauded
http://www.torontosun.com
By Kathleen Harris, National Bureau Chief
OTTAWA -- A controversial prison tattoo parlour program cancelled by the Conservative government was a cost-effective success in boosting education and cutting the risk of infectious diseases like HIV and hepatitis C that run rampant behind bars, a Correctional Service of Canada report says.
A 70-page evaluation found the $1-million federal pilot program led to enhanced awareness about blood-borne diseases among inmates and staff, more employment for prisoners and safer disposal of used sharps.
"Initial results of the initiative indicate potential to reduce harm, reduce exposure to health risk and enhance the health and safety of staff members, inmates and the general public," states one of the report's 11 key findings.
The report, dated January 2009 but just publicly released, also deemed the cost of the initiative "low" compared to its potential benefit.
The project was launched in 2005 at six federal prisons but canned by Stockwell Day, then public safety minister, the following year, just months after the Conservatives took office.
Last night, a spokesman for Public Safety Minister Peter Van Loan said the government has no plan to resurrect the program.
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Liver donor comes through for ailing Smithfield lieutenant
http://hamptonroads.com
By Hattie Brown Garrow
The Virginian-Pilot
After months of prayer and pleas for a donor, the timing could be called divine.
On Easter Sunday, Smithfield police Lt. Kurt Beach headed to Richmond's Hume-Lee Transplant Center for the life saving surgery he's needed since contracting hepatitis C on the job. Beach was in recovery Tuesday after receiving a liver transplant from a living donor.
"He's doing great," said his sister Eva Beach Dalton. "He's lucid. He's alert and he's got a smile on his face."
Since last year, Kathie Beach has kept family, friends and the media apprised of her husband's condition with frequent e-mails. It was in one of those messages that she announced his successful transplant.
"God's peace is with us both and we are so amazed at the way things have unfolded," Kathie Beach wrote. "His surgery went well with minimal bleeding and he has already been taken off the breathing tube."
The family kept the procedure a secret until Tuesday, she said, because the donor asked to remain anonymous.
"We are told our Hero donor is a wonderful man who smiles a lot," Beach wrote. "We do not know who he is and may never know."
Kurt Beach was infected with hepatitis C in 1988 during a failed attempt to save the life of an infant. His liver problems - a result of the disease - became so critical last fall that he began searching for a living donor. He feared the wait for a deceased donor would be too long.
Hume-Lee was inundated with potential donors - many who had never met Beach but had heard his story. At least twice, Beach was rushed to Richmond because a potential match had been found, but those visits ended in disappointment.
Beach landed in the hospital several times over the past few months because of declining health, the most recent stay due to an infection in his blood. He is on leave from the Smithfield Police Department.
Gov. Timothy M. Kaine recently signed legislation awarding Beach $250,000 to cover organ anti-rejection drugs and other medical costs. Though he contracted hepatitis C while on duty as a police officer, Beach never received workers' compensation because he was diagnosed after the state's five-year statute of limitations had expired.
The hospital is not allowing visitors other than family. Once released, Beach will recuperate at Virginia Commonwealth University Medical Center's Hospitality House.
Hattie Brown Garrow, (757) 222-5562, hattie.brown@pilotonline.com
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April 16, 2009
Can-Fite set for liver cancer treatment study
http://www.globes.co.il
The company intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Can-Fite BioPharma Ltd. (TASE:CFBI) has begun recruiting patients for the Phase I/II clinical trial of CF-102 treatment for liver cancer, after obtaining permission from the Ministry of Health and Rabin Medical Center (Beilinson Hospital) ethics committee.
The clinical trial will examine the safety and effectiveness of CF-102 on 40 patients at the Rabin Medical Center. Patients will receive increasing dosages of the drug during the trial period.
Can-Fite intends to initially develop CF-102 for liver diseases, including cancer and hepatitis C.
Liver cancer is one of the commonest forms of cancer worldwide, striking 450,000 new patients a year. It is especially prevalent among people suffering from hepatitis B and C, and alcoholics.
Can-Fite added that it expects in the coming weeks to announce the results of clinical trials for its drug, CF-101, for the treatment of rheumatoid arthritis and dry-eye syndrome (keratoconjunctivitis sicca). If the trials are successful, the company will begin Phase III trials of the drug for these indications.
Can-Fite's share jumped 11.2% in morning trading to NIS 1.30.
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Patients at Dakota Dunes, SD clinic tested for possible infection
http://www.ktiv.com
DAKOTA DUNES, S.D. (KTIV) - Thousands of people in Siouxland are now at risk for HIV and hepatitis because of a mistake made by a local health care provider.
South Dakota's Health Department says Siouxland Urology used products meant for one-time use more than once before throwing them away.
Steps are now being taken to correct the error.
According to the Siouxland Urology Center in Dakota Dunes, South Dakota more than five-thousand of their patients may have been exposed to blood born pathogens like HIV and Hepatitis.
"It is a very low risk that a patient would be exposed, however the potential for exposure exists," said Bob Stahl with the South Dakota Department of Health.
Earlier this year, in a routine check by the South Dakota Department of Health, officials discovered medical personnel at the Siouxland Urology Center, were re-using saline bags used in a cystoscopy procedure.
"It was determined that a single saline solution bag and tubing were being re-used on multiple patients before it was being discarded," said Stahl.
A saline solution bag is used in a cystoscopy procedure. The bag is connected to the cystoscope which allows your doctor to look inside the bladder and the urethra to check for cancer or other illnesses. Stahl (Stall) says officials at the Siouxland Urology Center had not been following manufactures recommendations that says an unused bag of saline solution should be used for every patient.
"This could potentially expose the patient to a blood born pathogen, if that tubing received the pathogen and then was re-used on another patient," said Stahl.
"And for now officials with Siouxland Urology are giving their patients free blood tests. Results could take up to two weeks to get back.
According to the Department of Health, the Siouxland Urology Center has been put on a "provisional" license.
The Urology Center has passed a revisit by the department of health.
But results on those patients who have or plan to take the free blood test have not yet been received by the department of health.
Online Reporter: Melissa Lanzourakis
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Do patients at risk for B-cell malignancy need antiviral treatment?
http://www.news-medical.net/
Some studies have shown that a relationship of hepatitis C (HCV) infection with type II mixed cryoglobulinemia exists.
However the precise mechanism remains unclear.
A research article to be published on April 7, 2009 in the World Journal of Gastroenterology addresses this question. The research team led by Professor Fan from the Department of Infectious Disease of the People's Liberation Army 161 Hospital in Wuhan used IgH rearrangement and immunohistochemistry. Various research studies indicated a relationship between the B-cell clonality with non-Hodgkin lymphoma, and this article further investigates the risk for developing malignant lymphoproliferative disease in the HCV-infected patients with B-cell clonality in the liver.
Liver-infiltrating monoclonal B-cells were detected in the liver of 4 (10%) of 40 HCV-positive patients but were present in only 3 (0.37%) of 808 liver biopsy specimens with chronic HBV infection. Chi-square tesing showed the monoclonal B-cells infiltrating in the liver were more frequent in the HCV-infected patients (P=0.000).A clonal IgH rearrangement was detected in 5 (71.4%) of 7 liver biopsy specimens with monoclonal B-cells infiltration. In 2 of 5 patients with both a clonal B-cell expansion and monoclonal B-cells infiltration in the liver, a definite B-cell malignancy was finally diagnosed.
Recent reports have highlighted the importance of antiviral treatment in the HCV-infected patient with B-cell clonality in the liver. This is the first study to analyze the association of monoclonal B-cells infiltrating in the liver with the B-cell clonality. Furthermore, our follow up study showed that lymphoma developed more frequently in the patients who had monoclonal B-cells infiltration and B-cell proliferation in the liver. The presence of a B-cell clonality and monoclonal B-cells infiltrating in the liver may be useful for detecting patients at high risk for developing malignant lymphoproliferative disease. The study results suggest a strategy for antiviral treatment in patients at risk for B-cell malignancy.
http://www.wjgnet.com/
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Report: Stroke's effects hurt Desai in defense effort
http://www.lvrj.com
By Paul Harasim
Las Vegas Review-Journal
The residual effects of a July stroke would make it difficult for Dr. Dipak Desai, whose endoscopy centers are linked to a hepatitis outbreak, to assist his attorney in defending himself against malpractice charges, according to a report filed today with the Nevada Board of Medical Examiners.
The report, filed by hearing officer Patrick Dolan, is based on the results of a battery of tests conducted by Thomas K. Kinsora, a Las Vegas clinical neuropsychologist.
Dolan ordered the independent exam in February because medical records submitted from Desai’s legal team dating back to September 2008 continued to show his condition had not improved, repeatedly delaying board action on the malpractice claim.
Kinsora, who is not a medical doctor, recommended additional medical testing, including brain imaging and speech evaluation, Dolan said in his report. Kinsora said he also needed to access and evaluate additional medical records.
Additional testing was recommended “to assist in confirming the extent of any impairment ... and to provide a course of treatment and time table for when — if ever — (Desai) could be anticipated to overcome such impairment.”
In the report, Dolan ordered that the testing be carried out and that a July 14 status conference be held on Desai’s diagnosis and prognosis as it relates to his ability to participate in his malpractice defense.
Attempts to reach Dolan and Kinsora for comment today were unsuccessful. Kinsora’s findings conflict with those of a medical expert who, according to Deputy District Attorney Scott Mitchell, examined the 58-year-old Desai’s medical records. Those records included brain scans from UCLA, where Desai was initially treated.
Though unavailable for comment today, Mitchell told the Review-Journal in January that the medical expert who examined Desai’s records for law enforcement did not find evidence of effects from the stroke that would make Desai unable to participate in his defense in a criminal proceeding.
Las Vegas police, the FBI, the IRS, and attorney general’s office currently have investigations underway involving Desai.
Mitchell has not named the physician who examined Desai’s medical records.
In July, attorneys for Desai told the medical board that after the stroke the physician couldn’t recognize a wristwatch. Mitchell downplayed such talk: “When it comes to the wristwatch, I’d say he might not have been able to recognize it one minute after the stroke; but an hour later that would have been different.”
A stroke occurs when a blood vessel bringing oxygen and blood to the brain ruptures or gets blocked so brain cells don’t get the flow of blood they need. Paralysis can occur.
District Attorney David Roger, whose office had planned to start criminal proceedings against Desai this summer, declined comment today on Dolan’s report. Richard Wright, Desai’s attorney, also declined comment.
Will Kemp, an attorney for several individuals who have brought civil lawsuits against Desai and other members of his medical team, said it is too early to know how this latest finding could affect legal action.
Kemp said, however, that it is unlikely that Dolan’s report would stop any criminal action. “I don’t know too many indictments that are stopped by a doctor’s note,” he said.
Louis Ling, executive director for the medical board, said he did not how Dolan chose Kinsora for the independent medical exam.
A clinical neuropsychologist is a licensed psychologist with expertise in how behavior and skills are related to brain structures and systems. Neuropsychological tests are designed to examine several cognitive abilities, including language, memory, attention and speed of information processing.
Dolan’s latest order for more tests on Desai comes more than a year after the Southern Nevada Health District sent notification to more than 50,000 former patients of the Endoscopy Center of Southern Nevada urging them to be tested for hepatitis and HIV because of unsafe injection practices spanning a four-year period at the clinic.
Nine people contracted hepatitis at the clinics, health officials said. More than 100 other cases have been characterized as possibly linked. Desai and two other physicians have been hit with medical malpractice complaints relating to the care they provide patients.
While the disciplinary hearings for Drs. Eladio Carrera and Clifford Carrol are scheduled for later this summer, the scheduling of Desai’s hearing has hinged on his ability to participate in his defense.
Desai and Carrera have both had their licenses suspended pending the outcome of disciplinary hearings; Carrol is still allowed to practice medicine.
Assemblywoman Sheila Leslie, D-Reno, isn’t sure that the board and its hearing officer handled this exam of Desai “in a manner that will sit well with the people of Las Vegas.”
Leslie said Kinsora may be a fine clinician, but she thinks it would have been better to select someone to conduct the testing who lives far away from Southern Nevada with no knowledge of Desai.
“People know of the incestuous nature of the medical board in the past,” said Leslie, who has held hearings on the hepatitis outbreaks. “You would think they would want to be beyond reproach.”
But Ling said today he is sure that Dolan would not have picked Kinsora for the evaluation if he was a friend of Desai or worked with him.
Leslie said it appears that the medical evaluation of Desai has taken too much time.
“I want the experts to do everything they can in finding out if there is something wrong with him,” she said. “But this appears to be another stalling technique.”
Dolan didn’t order a medical evaluation of Desai until eight months after his stroke. A member of the Hindu Temple in Summerlin attended by Desai said today that the physician “shows up at least once a week and seems fine.
“He talks and participates,” said the member, who spoke on condition of anonymity.
Review-Journal writer David Kihara contributed to this report.
Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.
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April 17, 2009
Formula for justice Chemist snags $45M settlement after blowing whistle on med company
http://www.nydailynews.com
BY John Marzulli
A WHISTLEBLOWER who told the feds that a giant lab was making inaccurate test kits for dialysis patients will get $45 million under a settlement reached yesterday in Brooklyn Federal Court.
Thomas Cantor, a biochemist whose company supplied different test kits to clinical labs, isn't spending his newfound millions like a lottery winner.
"I'm not going to pocket it, the money part was never the motivation," Cantor told the Daily News from Tokyo.
"It was always about patients. It broke my heart and was shocking what a company would do for money."
"I made it my business to go on a mission to make it stop."
Cantor, 58, said the award money will fund research to treat drug-resistant infections like HIV and hepatitis.
Five years ago, Cantor and his lawyers at the Washington firm of Phillips & Cohen sued Quest Diagnostics and its subsidiary Nichols Institute Diagnostics for Medicare fraud.
Cantor's suit contended Quest and NID were billing the government for faulty medical tests and harmful Vitamin D therapies for inaccurately diagnosed kidney disease.
Cantor, president of Scantibodies Laboratory Inc., in California, said he learned of problems with Quest's faulty test kits after some doctors who disputed Quest's results asked him to conduct a second test.
Cantor's tests showed Quest's findings were consistently out of whack.
NID pleaded guilty to a felony charge of misbranding relating to a thyroid test for dialysis patients yesterday and agreed to pay a $40 million fine, court papers say.
In addition, Quest and NID agreed to pay the government a $262 million civil settlement.
Under the federal False Claims Act, Cantor is entitled to a percentage of the settlement as an encouragement for whistleblowers to come forward. Before suing, Cantor sent thousands of e-mails to health care providers about the inaccurate tests without success. The feds then investigated his allegations.
"The American public has a right to expect medical device manufacturers to make accurate claims in their labeling, especially when the failure to meet those claims could indicate that the performance of the device is suspect," Brooklyn U.S. Attorney Benton Campbell said.
jmarzulli@nydailynews.com
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Miami VA tests find 7 cases of hepatitis C, 1 HIV
http://www.miamiherald.com
Fred Tasker
One patient who had a colonoscopy at the Veterans Affairs hospital in Miami using equipment that was not properly sterilized has tested positive for HIV. Seven patients have confirmed cases of hepatitis C. No local patients were positive for hepatitis B.
The VA confirmed the number in a press release Friday but cautioned that there is no way to know if the veterans contracted the viruses from the VA equipment or in other ways.
All three viruses to which veterans might have been exposed are serious and contagious under some circumstances.
Hepatitis B is a liver disease that can range from mild, temporary illness to serious chronic conditions, and hepatitis C can lead to cirrhosis of the liver and liver cancer. HIV, or the Human Immunodeficiency Virus, can lead to AIDS.
Dan Shannon, a Broward veteran who had two colonoscopies at the Miami VA hospital, got a letter saying his tests were negative, but wasn't entirely reassured.
''I'm going to go outside and get a second opinion from a private doctor, just as a precaution,'' he said.
''Wow, that's a bummer,'' said Stuart McLees, Vietnam vet and commander of a Davie VFW post, who had six colonoscopies at the Miami VA after an operation for colon cancer. McLees also received a letter from the VA that his test was negative.
''I'm still a little shaky,'' he said. "But I've been treated well at the VA hospital, so I really have no complaints.''
In its news release, the VA said that, of 3,341 Miami veterans who had colonoscopies with the improperly cleaned equipment, 3,184 have been notified, 2,038 have asked for testing, 1,880 were tested and 1,639 so far have been notified of their results.
VA officials in Washington and Miami did not immediately respond to calls for further comment. It isn't known whether colonoscopies, which were suspended in Miami when the problem came to light, have resumed.
The VA announcement said: "Although the risk of cross-contamination and exposure to these infections is exceptionally low, our directive is to treat all veterans potentially affected, regardless of risk, and regardless of cause.''
The problem with the came to light in late March, after the Miami VA sent letters to more than 3,000 veterans who had received colonoscopies there between May 2004 and March 12, warning that improperly sanitized equipment might have exposed them to the three dangerous viruses. Miami VA hospital chief of staff Dr. John Vara later said a staffer apparently had been rinsing parts of the equipment instead of chemically sanitizing them between uses, as recommended by the manufacturer.
Similar problems took place at VA medical facilities in Murfreesboro, Tenn., where nearly 6,400 veterans were told they might have been infected, and in Augusta, Ga., with nearly 1,100 veterans.
At those facilities, the VA on Friday reported that in Murfreesboro, 6,387 were potentially exposed, five tested positive for hepatitis B, seven for hepatitis C and one for HIV. In Augusta, 1,069 were potentially exposed, one tested positive for hepatitis B, five for hepatitis C and one for HIV.
The problem was first detected in Murfreesboro in December. In March, the national VA directed all 153 VA medical facilities to do a formal ''step-up'' inspection and retraining program about the equipment. That's when the problem was discovered in Miami.
A team of doctors and administrators from the national VA has been at the Miami VA hospital since the last week of March poring over records, interviewing staffers, and trying to figure out how the Miami VA Medical Center, which won a ''Best in VA'' award in 2007, could have made such a fundamental error as rinsing instead of disinfecting the equipment.
Dr. David Greenwald, a gastroenterologist at Montefiore Medical Center in New York and a spokesman for the American Society for Gastrointestinal Endoscopy, said that despite the apparent breach of protocol, people should not fear getting colonoscopies at civilian medical facilities.
''Colonoscopy is a very effective procedure for cancer screening,'' he said. "It's important to note that if the guidelines are followed, there should be no fear of infection.''
All civilian hospital and clinics -- but not the VA centers and clinics -- are inspected periodically by the Florida Agency for Health Care Administration, which also responds to patient complaints. Hospitals must report any ''adverse incidents'' to the state agency.
Doctors and staffers at local hospitals also say procedures are in place to catch such problems immediately.
''We have such a culture of constant observation here that that kind of thing would not happen. It would be weeded out very quickly,'' said Barbara Russell, spokeswoman for Baptist Hospital in Kendall.
Baptist, she said, has several overlapping standards and procedures to be sure safety rules are met, including a quality control protocol called Toyota Lean Thinking, devised by the automaker to control its manufacturing quality and adapted for use in business offices, hospitals and other institutions.
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