Sometimes, you just have to wonder. How did a drug like propofol, slip by the radar screen of the DEA? Are they too busy prosecuting the use of marijuana, fighting off Mexican bandits, or was this just a Bush administration decision to look the other way?
Attorney Gordon Johnson
http://tbilaw.com
http://waiting.com
http://heparin-law.com
Date: 7/15/2009 4:45 PM
DEVLIN BARRETT,Associated Press Writer
WASHINGTON (AP) — Federal authorities are considering making the potent anesthetic propofol — one of the drugs found in Michael Jackson's home — a controlled substance, which would put new limits on its distribution.
The Drug Enforcement Administration was petitioned two years ago to make propofol a scheduled drug under the Controlled Substances Act. That designation is used to impose restrictions on distributing and prescribing certain drugs prone to abuse and addiction.
DEA spokesman Rusty Payne confirmed Wednesday that the agency is considering adding propofol to the list of controlled substances. The brand-name version of propofol is called Diprivan. A nurse who provided nutritional therapy for Jackson, Cherilynn Lee, has said he asked her for Diprivan to treat insomnia. Propofol is not recommended for such use and Lee said she refused the star's request.
Until Jackson's death, the main concern about propofol was its potential for abuse by medical staff, because it is usually administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures.
The Food and Drug Administration has received an increasing number of reports about fatalities linked to propofol in recent years: 43 in 2008 and 35 in 2007, up from an average of 22 per year over the decade before that, according to FDA data. The increase may be due to increasing use of propofol over older barbiturates.
A central question in the Jackson investigation is who provided that drug and other prescription medications found at his rented Beverly Hills mansion. Investigators are talking to doctors who treated Jackson.
Adding a drug to the federal list of controlled substances is a lengthy process. As part of its review, the DEA asks for a recommendation from officials at the Department of Health and Human Services. HHS experts can stop a drug from being added to the list if they recommend against doing so. Congress can also add specific drugs to the list through legislation.
The federal list of controlled substances is divided into five categories, ranging from some of the most potent, like heroin, to much milder products, like cough medicine with codeine.
Propofol is the country's most widely used drug to induce general anesthesia, and also is used for other types of health provider-based sedation, said Dr. Stephen Parker, anesthesia chairman at Washington Hospital Center in the nation's capital.
Hospitals and doctors' offices must follow specific monitoring requirements for different levels of controlled substances, to track how much is bought and used, and who uses it.
Changing propofol to a controlled substance would require "accounting for every cc of the drug that was used," Parker said, referring to the way the doses are measured. A teaspoon is about 5 cc's.
"It would put up barriers for us to easily use the drug," he said. "It's a lot of bureaucracy and expense, frankly."
For at least two years, the American Society of Anesthesiologists has had a committee looking into whether propofol should be made a controlled substance, but this has not been a high priority because abuse of propofol is "much, much less common" than of painkillers such as OxyContin, said Dr. David Zvara, anesthesia chairman at the University of North Carolina at Chapel Hill.
"It's the drug you get when they say count back from 100 and you only make it to 97," Zvara said. "It quickly and reliably puts people under — usually, very safely."
At his university, it is used for about four out of every five procedures and is favored over older drugs like Pentothal and other barbiturates.
However, propofol depresses breathing and the heart rate and lowers blood pressure — risks that must be constantly monitored.
When it is abused, it's usually by people seeking sleep, but even that is misguided, Zvara said.
___
Associated Press Medical Writers Lauran Neergaard in Washington and Marilynn Marchione in Milwaukee and AP writer Justin Pritchard in Los Angeles contributed to this report.
Copyright 2009 The Associated Press.
Wednesday, July 15, 2009
Monday, July 13, 2009
Scrub tech causes major hepatitis scare in Colo.
Drug addicts and dirty needles. It is the stuff of disturbing stories of pathetic street addicts.. But when that happens inside of a hospital? What a catastrophe. Talk about a dangerous drug - Hepatitis C.
Attorney Gordon Johnson
http://tbilaw.com
http://waiting.com
Date: 7/11/2009 1:26 PM
P. SOLOMON BANDA,Associated Press Writer
DENVER (AP) — Kimberly Spencer's 9-year-old son went to Audubon Ambulatory Surgery Center last month for what was supposed to be a routine surgery. The rambunctious child stuck a BB in his ear and doctors had to operate to remove it.
What happened next shocked the family. They were notified that their son is one of 6,000 patients who may have been exposed to hepatitis C by a painkiller-addicted technician who had the disease and allegedly passed on dirty syringes to patients.
The technician has been jailed, thousands of rattled patients have been getting hepatitis C tests, and two medical facilities where she worked have been bombarded with questions about how they let it happen. Ten cases of hepatitis C have been linked to Rose Medical Center, where Kristen Diane Parker worked until April.
"It was originally a humorous child story we could write about in his baby book and now it's just gone south a little bit," Spencer said Friday as she awaited results of her son's blood test. "We're very optimistic, we think it's going to be just fine. It's still unnerving."
During a police interview videotaped June 30 that was played in court Thursday, the 26-year-old Parker told a detective that she kept dirty saline-filled syringes in her pocket and watched for opportunities when doctors and nurses left the room. She then allegedly stole syringes filled with Fentanyl from operating carts and replaced them with the used syringes.
"I didn't want to make it obvious to everyone that I was using," the 26-year-old Parker told the detective in the interview, saying she stole between 15 and 20 syringes of Fentanyl. "I knew my limit."
Health officials are conducting tests to determine if the 10 hepatitis C cases are definitively linked to Parker. Many people with hepatitis C don't know they are infected because they don't develop symptoms until years later.
Parker said she used between 100 to 250 micrograms of the drug each time, roughly enough medication for a 500-pound person, according to medical malpractice attorney Dr. Eric Steiner, a former cardiac anesthesiologist.
Thousands of former surgery patients have contacted Denver's Rose Medical Center and Audubon Ambulatory Surgery Center in Colorado Springs for free blood tests being offered by both facilities. More than 1,900 former Rose patients have been tested, said hospital spokeswoman Leslie Teegarden.
An Audubon spokesman did not return messages Friday, but state health officials said those at that facility, including Spencer's son, will be tested again in about seven weeks because it takes that long for the disease to show up in the bloodstream. Hepatitis C is a treatable but incurable blood-borne disease that can cause serious liver problems.
Despite a hopeful attitude for Spencer, mundane every day occurrences have taken on disproportionate significance, such as Thursday when her son fell off his bike and skinned his knee.
"A simple little scrape to me is, 'Oh my gosh,' we need to take care of that, wash our hands, bandage him up. It makes you think twice, for everybody; the children he's playing with, the children I have at home. At the same time I don't want to overreact for him. He's nine.
"It's probably going to be like this for six more weeks until we know for sure."
Parker's case could end up being the first in Colorado where a patient got an infection from a health care worker who was tampering with drugs, said Dr. Ned Calonge, chief medical officer for the state health department.
Nationwide, there were four documented cases of nurses and doctors infecting patients with hepatitis C between 1992 and 2003, according to the latest information from Centers for Disease Control. A 1992 case cited in the CDC study involved a surgical technician who was using anesthesia medications.
Parker gave several reasons for using Fentanyl, which is a narcotic 80 to 100 times more powerful than morphine: to deal with a custody battle with her ex-husband over her 2-year-old son; six-hour stretches of being on her feet; and back pain from the physical requirements of moving patients around the operating rooms.
She also said she had a problem with painkillers in the past and she may have gotten hepatitis C when she used heroin last summer while living in New Jersey.
"She's going to take responsibility," Parker's attorney Gregory Graf said. He had argued that Parker should be released on bail because her cooperation with investigators proves she was not a flight risk.
A key point that could lead to more serious charges is whether she knew she was infected with hepatitis C.
She tested positive for the disease before starting her job at Rose in October, but she didn't follow up when told about it because she didn't have health insurance or money for a doctor and she got distracted with her new job.
She also said hospital officials didn't make it clear she tested positive. A federal magistrate judge disagreed and declared her a danger to the community and ordered her held without bond, saying her actions showed significant disregard for the safety of others. Her next hearing is Oct. 6.
Those infected with hepatitis C are not barred from working in health services, so long as standard precautions are taken, according to the CDC.
"She knew she had hepatitis C, she's a health care worker and she understands how this disease is spread," said Pat Criscito, 56, an author and freelance writer from Monument south of Denver. She underwent back and hand surgery at Rose last fall and spent a sleepless night worrying about hepatitis C while she waited for her test results. Criscito said a positive result would have been meant certain death because years of arthritis treatment have severely weakened her immune system.
"If I was going to die, she deserves life in prison. I can't understand how somebody can do that to another human being," Criscito said, who tested negative and is waiting the results of a second test.
Hospital and state health officials aren't sure how many people were injected with Parker's dirty needles or with saline solution contaminated when Parker allegedly dipped her dirty needles to fill bogus syringes to cover her tracks.
Denver police launched a drug investigation in April and the state health department began its investigation June 1 after former Rose surgery patients began testing positive for hepatitis C. Parker was arrested June 30 on state drug charges, but Denver police turned the case over to federal agents when they discovered the tampering.
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
http://tbilaw.com
http://waiting.com
Date: 7/11/2009 1:26 PM
P. SOLOMON BANDA,Associated Press Writer
DENVER (AP) — Kimberly Spencer's 9-year-old son went to Audubon Ambulatory Surgery Center last month for what was supposed to be a routine surgery. The rambunctious child stuck a BB in his ear and doctors had to operate to remove it.
What happened next shocked the family. They were notified that their son is one of 6,000 patients who may have been exposed to hepatitis C by a painkiller-addicted technician who had the disease and allegedly passed on dirty syringes to patients.
The technician has been jailed, thousands of rattled patients have been getting hepatitis C tests, and two medical facilities where she worked have been bombarded with questions about how they let it happen. Ten cases of hepatitis C have been linked to Rose Medical Center, where Kristen Diane Parker worked until April.
"It was originally a humorous child story we could write about in his baby book and now it's just gone south a little bit," Spencer said Friday as she awaited results of her son's blood test. "We're very optimistic, we think it's going to be just fine. It's still unnerving."
During a police interview videotaped June 30 that was played in court Thursday, the 26-year-old Parker told a detective that she kept dirty saline-filled syringes in her pocket and watched for opportunities when doctors and nurses left the room. She then allegedly stole syringes filled with Fentanyl from operating carts and replaced them with the used syringes.
"I didn't want to make it obvious to everyone that I was using," the 26-year-old Parker told the detective in the interview, saying she stole between 15 and 20 syringes of Fentanyl. "I knew my limit."
Health officials are conducting tests to determine if the 10 hepatitis C cases are definitively linked to Parker. Many people with hepatitis C don't know they are infected because they don't develop symptoms until years later.
Parker said she used between 100 to 250 micrograms of the drug each time, roughly enough medication for a 500-pound person, according to medical malpractice attorney Dr. Eric Steiner, a former cardiac anesthesiologist.
Thousands of former surgery patients have contacted Denver's Rose Medical Center and Audubon Ambulatory Surgery Center in Colorado Springs for free blood tests being offered by both facilities. More than 1,900 former Rose patients have been tested, said hospital spokeswoman Leslie Teegarden.
An Audubon spokesman did not return messages Friday, but state health officials said those at that facility, including Spencer's son, will be tested again in about seven weeks because it takes that long for the disease to show up in the bloodstream. Hepatitis C is a treatable but incurable blood-borne disease that can cause serious liver problems.
Despite a hopeful attitude for Spencer, mundane every day occurrences have taken on disproportionate significance, such as Thursday when her son fell off his bike and skinned his knee.
"A simple little scrape to me is, 'Oh my gosh,' we need to take care of that, wash our hands, bandage him up. It makes you think twice, for everybody; the children he's playing with, the children I have at home. At the same time I don't want to overreact for him. He's nine.
"It's probably going to be like this for six more weeks until we know for sure."
Parker's case could end up being the first in Colorado where a patient got an infection from a health care worker who was tampering with drugs, said Dr. Ned Calonge, chief medical officer for the state health department.
Nationwide, there were four documented cases of nurses and doctors infecting patients with hepatitis C between 1992 and 2003, according to the latest information from Centers for Disease Control. A 1992 case cited in the CDC study involved a surgical technician who was using anesthesia medications.
Parker gave several reasons for using Fentanyl, which is a narcotic 80 to 100 times more powerful than morphine: to deal with a custody battle with her ex-husband over her 2-year-old son; six-hour stretches of being on her feet; and back pain from the physical requirements of moving patients around the operating rooms.
She also said she had a problem with painkillers in the past and she may have gotten hepatitis C when she used heroin last summer while living in New Jersey.
"She's going to take responsibility," Parker's attorney Gregory Graf said. He had argued that Parker should be released on bail because her cooperation with investigators proves she was not a flight risk.
A key point that could lead to more serious charges is whether she knew she was infected with hepatitis C.
She tested positive for the disease before starting her job at Rose in October, but she didn't follow up when told about it because she didn't have health insurance or money for a doctor and she got distracted with her new job.
She also said hospital officials didn't make it clear she tested positive. A federal magistrate judge disagreed and declared her a danger to the community and ordered her held without bond, saying her actions showed significant disregard for the safety of others. Her next hearing is Oct. 6.
Those infected with hepatitis C are not barred from working in health services, so long as standard precautions are taken, according to the CDC.
"She knew she had hepatitis C, she's a health care worker and she understands how this disease is spread," said Pat Criscito, 56, an author and freelance writer from Monument south of Denver. She underwent back and hand surgery at Rose last fall and spent a sleepless night worrying about hepatitis C while she waited for her test results. Criscito said a positive result would have been meant certain death because years of arthritis treatment have severely weakened her immune system.
"If I was going to die, she deserves life in prison. I can't understand how somebody can do that to another human being," Criscito said, who tested negative and is waiting the results of a second test.
Hospital and state health officials aren't sure how many people were injected with Parker's dirty needles or with saline solution contaminated when Parker allegedly dipped her dirty needles to fill bogus syringes to cover her tracks.
Denver police launched a drug investigation in April and the state health department began its investigation June 1 after former Rose surgery patients began testing positive for hepatitis C. Parker was arrested June 30 on state drug charges, but Denver police turned the case over to federal agents when they discovered the tampering.
Copyright 2009 The Associated Press.
Sunday, July 5, 2009
Drug war, economy weigh on Mexico midterm election
What to do about Mexico? It is a land that I love, a place I once thought I would have a retirement home, a place with wonderful people and the most amazing scenery. My little slice of Mexico is 800 miles away from any of this strife, yet between swine flu and drug wars, I am reluctant to return. I miss my slice of heaven, yet the future there seems so tenuous, I may never get closer again than looking at these pictures.
Attorney Gordon Johnson
http://subtlebraininjury.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009
Date: 7/5/2009 2:40 AM
MARK STEVENSON,Associated Press Writer
MEXICO CITY (AP) — Drug violence, an economic downturn and recent cases of political malfeasance weigh heavily on Mexico's midterm congressional elections Sunday, a vote that could decide the future of President Felipe Calderon's anti-crime and economic policies.
Calderon's National Action Party, PAN, hopes its nationwide crackdown on drug cartels will win it a bigger share of the 500-seat lower house of Congress, where it currently holds 206 spots. But polls suggest the gains will go to the former longtime ruling Institutional Revolutionary Party, PRI, which now has 106 seats.
The PAN ran a bruising campaign in which it practically accused the PRI of tolerating drug trafficking. That angered PRI members, and if the party and its allies win enough seats to form a majority, it could block Calderon's efforts to reform police forces and give more police powers to 45,000 soldiers deployed to fight well-armed drug gangs.
The vote for 565 mayors and six governorships — including the northern border states of Nuevo Leon and Sonora — is also seen as a referendum on an economy that shrank 8.2 percent in the first quarter and is expected to contract 5.5 percent for the year as a whole.
The economic crisis has been compounded by a drop in money sent home by Mexicans working abroad and by a decrease in oil income from the slump in world petroleum prices. Those are Mexico's two biggest sources of foreign currency.
Many activists and intellectuals have urged voters to annul their vote or deface their ballot in protest against the largely government-funded political parties that have done little to break Mexico out of the doldrums. But many more Mexicans — perhaps as many as 70 percent of the 77.5 million registered voters — are likely to simply stay away from the polls.
The PRI appears likely to win most statehouse races. One of the PAN's biggest hopes lies in Sonora, where the PRI state government's image suffered after a fire at an ill-equipped, government-approved day-care center killed 48 children in June.
A wave of arrests of public servants and police for drug-related corruption and a string of highly publicized kidnappings and extortions have added to the disenchantment with politicians.
The leftist Democratic Revolution Party, whose candidate Andres Manuel Lopez Obrador barely lost the 2006 presidential race to Calderon, currently has 126 seats in Congress but has suffered serious internal splits and is expected to drop precipitously after some of its more militant members turned to the smaller Labor Party.
The PRI ruled Mexico for more than seven decades until it lost the presidency in the 2000. While it was long held together by the all-powerful figure of the president, the party has become more fractious and dominated by state leaders and regional interests since losing national power.
Angry over the mudslinging campaign and already looking to regain the presidency in 2012, the PRI could become a spoiler for any future reform proposals. Its extensive party machine and broad national presence would give it an edge in the event of a small turnout or a large number of protest votes.
"To the extent people nullify their ballots, institutions will be weakened and the PRI's network of control will go into action, and they will win a majority," warned the conservative, PAN-aligned civic group Better Society, Better Government.
The null-vote movement wants reforms such as reducing the generous government funding for parties, making recalls of elected officials easier and allowing write-in votes or independent candidates.
Copyright 2009 The Associated Press.
Floods trap 300 teens at school in southern China
Date: 7/5/2009 10:05 AM
GILLIAN WONG,Associated Press Writer
BEIJING (AP) — Floods blocked roads in southern China, leaving some 300 teenagers stranded at a school with limited supplies of food and water, an official said Sunday, after days of heavy rain killed at least 15 people.
About 550,000 people have fled their homes in southern China after heavy rains toppled houses, flooded roads and damaged a dam, news reports said.
Flood waters blocked the entrances to the Hemu Town Middle School in the Guangxi region and rendered nearby roads impassable, according to an official of Rongshui county where the school is. She would only give her surname, Lu.
CCTV said Sunday that floodwaters along a major commercial thoroughfare elsewhere in Rongshui were more than eight feet (2.5 meters) deep. The report said it was the highest water level the county has seen in a decade.
Flood control officials used boats to deliver food, mineral water and other supplies to the school on Saturday, including pumps to lower the water level, Lu said.
She said she did not know how long the children, aged from 13 to 15 years, had been stuck in the building.
By Friday, 80 percent of the county was inundated, causing the Rongjiang river to overflow its banks and forcing the relocation of more than 70,000 people, Lu said.
Heavy rains have battered the region since Wednesday, forcing about 290,000 people in Guangxi to relocate, the official Xinhua News Agency said. The rains began to subside in parts of Guangxi on Sunday, but river levels remained high, the report said.
CCTV showed flooded Rongshui streets, where the signboards of restaurants and shops were all that could be seen above the water. Mattresses, household items and other debris drifted in the water, passing residents on wooden rowboats as people peered out from second-floor balconies and windows.
The county government estimated the damage at 210 million yuan ($31 million), Xinhua said.
The rain also destroyed a 44-foot (13-meter) section of a dike near the base of the Kama Reservoir in Guangxi, Xinhua said.
About 15,000 people who lived downstream from the dam were moved to safety and were now living in more than 1,000 tents, the national flood control office said in a statement Saturday.
In Hunan province, floods have killed eight people and forced 140,000 to relocate. Five people have died in southeastern Fujian province, two others were missing, and 22,000 people have been evacuated, Xinhua said Saturday.
Another two people died and three were missing in Jiangxi province. Another 100,000 people were forced from their homes.
Copyright 2009 The Associated Press.
GILLIAN WONG,Associated Press Writer
BEIJING (AP) — Floods blocked roads in southern China, leaving some 300 teenagers stranded at a school with limited supplies of food and water, an official said Sunday, after days of heavy rain killed at least 15 people.
About 550,000 people have fled their homes in southern China after heavy rains toppled houses, flooded roads and damaged a dam, news reports said.
Flood waters blocked the entrances to the Hemu Town Middle School in the Guangxi region and rendered nearby roads impassable, according to an official of Rongshui county where the school is. She would only give her surname, Lu.
CCTV said Sunday that floodwaters along a major commercial thoroughfare elsewhere in Rongshui were more than eight feet (2.5 meters) deep. The report said it was the highest water level the county has seen in a decade.
Flood control officials used boats to deliver food, mineral water and other supplies to the school on Saturday, including pumps to lower the water level, Lu said.
She said she did not know how long the children, aged from 13 to 15 years, had been stuck in the building.
By Friday, 80 percent of the county was inundated, causing the Rongjiang river to overflow its banks and forcing the relocation of more than 70,000 people, Lu said.
Heavy rains have battered the region since Wednesday, forcing about 290,000 people in Guangxi to relocate, the official Xinhua News Agency said. The rains began to subside in parts of Guangxi on Sunday, but river levels remained high, the report said.
CCTV showed flooded Rongshui streets, where the signboards of restaurants and shops were all that could be seen above the water. Mattresses, household items and other debris drifted in the water, passing residents on wooden rowboats as people peered out from second-floor balconies and windows.
The county government estimated the damage at 210 million yuan ($31 million), Xinhua said.
The rain also destroyed a 44-foot (13-meter) section of a dike near the base of the Kama Reservoir in Guangxi, Xinhua said.
About 15,000 people who lived downstream from the dam were moved to safety and were now living in more than 1,000 tents, the national flood control office said in a statement Saturday.
In Hunan province, floods have killed eight people and forced 140,000 to relocate. Five people have died in southeastern Fujian province, two others were missing, and 22,000 people have been evacuated, Xinhua said Saturday.
Another two people died and three were missing in Jiangxi province. Another 100,000 people were forced from their homes.
Copyright 2009 The Associated Press.
Friday, July 3, 2009
arrhythmia drug Multaq approved
Date: 7/2/2009 6:28 PM
LINDA A. JOHNSON,AP Business Writer
TRENTON, N.J. (AP) — Sanofi-Aventis SA said Thursday its drug Multaq, which treats irregular heart rhythms, received marketing approval from the Food and Drug Administration, which turned it down three years ago.
Multaq is intended to treat atrial flutter and atrial fibrillation, related heart disorders in which the organ's upper chambers occasionally beat rapidly and ineffectively, sometimes reducing blood flow through the body. The disorder often is associated with high blood pressure and heart disease, and can cause strokes and death.
"It's the first new anti-arrhythmic therapy that's been approved in over 10 years," Dr. Paul Chew, Sanofi's chief U.S. medical and scientific officer, said in an interview.
Multaq also is the first drug for atrial fibrillation that has been shown to reduce hospitalizations due to cardiovascular problems.
"Multaq represents a therapeutic innovation for treatment of ... atrial fibrillation," Dr. Norman Stockbridge, head of heart and kidney drugs at the FDA's Center for Drug Evaluation and Research, said in a statement.
Multaq, or dronedarone, will be sold in 400-milligram tablets intended to be taken twice per day. Sanofi-Aventis plans to launch the drug this summer. Officials said the price has not yet been determined.
Atrial fibrillation is the most common heart rhythm disorder. The company estimates there are 2.5 million atrial fibrillation patients in the U.S., and another 4.5 million in the European Union, where the company expects a decision on whether the drug will be approved by the end of this year.
In August 2006, the Food and Drug Administration rejected the French drugmaker's request for approval. That was after a widely publicized study called ANDROMEDA found patients in the group taking Multaq were twice as likely to die as patients in the comparison group.
"Most, maybe all drug companies, might have thrown in the towel," Chew said.
But that study involved patients with severe heart failure, a condition where the heart no longer pumps enough blood that also puts patients at risk of atrial fibrillation. Many patients in the study did not even have the irregular rhythm.
So Sanofi did another study, called ATHENA, that included 4,628 patients with atrial fibrillation but not severe heart failure.
This time, results were positive: Multaq helped reduce hospitalization and death from heart-related problems by 24 percent, and it lowered the risk of both ischemic and hemorrhagic stroke by 34 percent.
An FDA cardiology panel in March recommended approval.
But on Thursday, the FDA said the drug will come with a black box warning, its most severe, stating Multaq can cause severe complications, including death, in people with recent severe heart failure and so should not be used in those patients. The most common side effects were fatigue, loss of strength, diarrhea, nausea and vomiting.
U.S. shares of Sanofi-Aventis fell 64 cents, or 2.1 percent, to $29.70 Thursday, when virtually all major drugmakers and the broader markets fell sharply. The day before, the FDA said it was reviewing the safety of Sanofi's synthetic insulin, Lantus, due to an inconclusive new study indicating a possibility it slightly raised risk of cancer.
The stock has traded between $23.95 and $37.11 over the past 52 weeks.
Copyright 2009 The Associated Press.
LINDA A. JOHNSON,AP Business Writer
TRENTON, N.J. (AP) — Sanofi-Aventis SA said Thursday its drug Multaq, which treats irregular heart rhythms, received marketing approval from the Food and Drug Administration, which turned it down three years ago.
Multaq is intended to treat atrial flutter and atrial fibrillation, related heart disorders in which the organ's upper chambers occasionally beat rapidly and ineffectively, sometimes reducing blood flow through the body. The disorder often is associated with high blood pressure and heart disease, and can cause strokes and death.
"It's the first new anti-arrhythmic therapy that's been approved in over 10 years," Dr. Paul Chew, Sanofi's chief U.S. medical and scientific officer, said in an interview.
Multaq also is the first drug for atrial fibrillation that has been shown to reduce hospitalizations due to cardiovascular problems.
"Multaq represents a therapeutic innovation for treatment of ... atrial fibrillation," Dr. Norman Stockbridge, head of heart and kidney drugs at the FDA's Center for Drug Evaluation and Research, said in a statement.
Multaq, or dronedarone, will be sold in 400-milligram tablets intended to be taken twice per day. Sanofi-Aventis plans to launch the drug this summer. Officials said the price has not yet been determined.
Atrial fibrillation is the most common heart rhythm disorder. The company estimates there are 2.5 million atrial fibrillation patients in the U.S., and another 4.5 million in the European Union, where the company expects a decision on whether the drug will be approved by the end of this year.
In August 2006, the Food and Drug Administration rejected the French drugmaker's request for approval. That was after a widely publicized study called ANDROMEDA found patients in the group taking Multaq were twice as likely to die as patients in the comparison group.
"Most, maybe all drug companies, might have thrown in the towel," Chew said.
But that study involved patients with severe heart failure, a condition where the heart no longer pumps enough blood that also puts patients at risk of atrial fibrillation. Many patients in the study did not even have the irregular rhythm.
So Sanofi did another study, called ATHENA, that included 4,628 patients with atrial fibrillation but not severe heart failure.
This time, results were positive: Multaq helped reduce hospitalization and death from heart-related problems by 24 percent, and it lowered the risk of both ischemic and hemorrhagic stroke by 34 percent.
An FDA cardiology panel in March recommended approval.
But on Thursday, the FDA said the drug will come with a black box warning, its most severe, stating Multaq can cause severe complications, including death, in people with recent severe heart failure and so should not be used in those patients. The most common side effects were fatigue, loss of strength, diarrhea, nausea and vomiting.
U.S. shares of Sanofi-Aventis fell 64 cents, or 2.1 percent, to $29.70 Thursday, when virtually all major drugmakers and the broader markets fell sharply. The day before, the FDA said it was reviewing the safety of Sanofi's synthetic insulin, Lantus, due to an inconclusive new study indicating a possibility it slightly raised risk of cancer.
The stock has traded between $23.95 and $37.11 over the past 52 weeks.
Copyright 2009 The Associated Press.
Friday, May 29, 2009
EPA: Miss. companies sold illegal Chinese engines
Date: 5/28/2009 10:47 PM
TIMOTHY R. BROWN
Associated Press Writer
JACKSON, Miss. (AP) — Three Mississippi companies are accused in a federal lawsuit of illegally importing and selling more than 78,000 small engines made in China.
The engines did not meet federal air pollution standards, the Environmental Protection Agency and the Department of Justice said Thursday in a joint news release.
The lawsuit marks the government's first court action in an effort to enforce emissions standards for portable generators, water pumps and other small engines, the EPA said.
The lawsuit was filed in U.S. District Court in Washington, D.C., against PowerTrain Inc., Wood Sales Co. Inc., and Tool Mart Inc., all based in Golden, a northeast Mississippi town near the Alabama state line.
A search of the Mississippi Secretary of State's Web site found Oneal Wood of Golden listed as president of all three companies.
Wood did not immediately return a phone message left at his home.
"That's just the government for you," a Wood Sales spokesman told The Associated Press about the lawsuit. He did not give his name and immediately hung up the phone.
A phone listing could not be found for PowerTrain Inc. and a message left with a spokeswoman for Tool Mart was not immediately returned.
EPA spokesman Dave Ryan said the engines were sold across the country online and through telemarketing. EPA estimates the 78,000 engines have contributed to excess emissions of more than 150 tons of hydrocarbons and nitrogen oxides and more than 5,000 tons of carbon monoxide.
The complaint says the "non-road" engines were imported and sold by the companies from September 2002 through at least May 2007. The engines emit carbon monoxide, volatile organic compounds and nitrogen oxides, that contribute to smog.
The lawsuit seeks civil penalties and for the companies to remedy the violations.
Copyright 2009 The Associated Press.
TIMOTHY R. BROWN
Associated Press Writer
JACKSON, Miss. (AP) — Three Mississippi companies are accused in a federal lawsuit of illegally importing and selling more than 78,000 small engines made in China.
The engines did not meet federal air pollution standards, the Environmental Protection Agency and the Department of Justice said Thursday in a joint news release.
The lawsuit marks the government's first court action in an effort to enforce emissions standards for portable generators, water pumps and other small engines, the EPA said.
The lawsuit was filed in U.S. District Court in Washington, D.C., against PowerTrain Inc., Wood Sales Co. Inc., and Tool Mart Inc., all based in Golden, a northeast Mississippi town near the Alabama state line.
A search of the Mississippi Secretary of State's Web site found Oneal Wood of Golden listed as president of all three companies.
Wood did not immediately return a phone message left at his home.
"That's just the government for you," a Wood Sales spokesman told The Associated Press about the lawsuit. He did not give his name and immediately hung up the phone.
A phone listing could not be found for PowerTrain Inc. and a message left with a spokeswoman for Tool Mart was not immediately returned.
EPA spokesman Dave Ryan said the engines were sold across the country online and through telemarketing. EPA estimates the 78,000 engines have contributed to excess emissions of more than 150 tons of hydrocarbons and nitrogen oxides and more than 5,000 tons of carbon monoxide.
The complaint says the "non-road" engines were imported and sold by the companies from September 2002 through at least May 2007. The engines emit carbon monoxide, volatile organic compounds and nitrogen oxides, that contribute to smog.
The lawsuit seeks civil penalties and for the companies to remedy the violations.
Copyright 2009 The Associated Press.
Wednesday, May 27, 2009
China lawyers in touchy cases could be disbarred
Date: 5/27/2009 4:32 PM
ALEXA OLESEN
Associated Press Writer
BEIJING (AP) — China's judiciary is warning law firms to rein in lawyers who take up human rights and other politically sensitive cases, lawyers said Wednesday, increasing the pressure in a government campaign that has so far failed to curb growing legal activism.
Lawyers said authorities had met or talked on the phone with senior members of at least nine law firms in recent weeks, urging them to not seek the renewal of licenses for certain lawyers or to submit partial applications that would allow authorities to reject them on technicalities.
If carried through, the disbarments would mark the broadest effort in recent years by China's authoritarian government to rein in a growing number of activist lawyers.
"Before they used to pressure individuals but now they have turned to this more systematic method," said Tang Jitian, whose employer, the Anhui Law Firm in Beijing, was among those warned. "The justice departments say the lawyers who defend human rights are inharmonious or unstable elements, but I think they are the ones who are unstable."
The campaign will have a "chilling effect" on the Chinese legal profession even if the lawyers currently under threat manage to get their licenses back, said Nicholas Bequelin, Asia researcher for New York-based Human Rights Watch.
While lawyers have had their credentials pulled in the past, threats, beatings and other acts of intimidation have been common.
"There is a concerted effort to retaliate against lawyers who have taken some of the most sensitive cases in recent months and years," Bequelin said. "The purpose is to deter all lawyers from taking those type of cases."
Among those facing disbarment is a lawyer for a noted Tibetan Buddhist monk and others who have defended practitioners of the banned Falun Gong spiritual movement or helped parents whose children died in last year's devastating earthquake in Sichuan province. Many children were killed in schools that parents and others say were fundamentally unsafe due to corruption, cost-cutting and poor design.
The Justice Bureau did not immediately respond to a faxed request for information Wednesday about accreditation delays and allegations of intimidation.
The warnings are especially chilling because they coincide with the license renewal period for both law firms and lawyers.
Lawyers said the implicit message was that firms should sabotage the applications of their "problem lawyers," or risk having their firm's license or the licenses of other employees rejected. The easiest ways for a firm to lose an employee, without having to fire them, are to submit incomplete accreditation paperwork or an unfavorable performance review, or to simply not submit an application at all, they said.
Tang, who has defended farmers against rural land grabs and challenged police detention without trials, said if his license was not renewed by Sunday, he would be barred from working.
At least 20 other lawyers spread across nine firms have reported the same delays in getting their licenses renewed, Tang and other lawyers said.
Jiang Tianyong, a lawyer with Beijing's Gaobo Longhua Law Firm, said his application was still pending.
"They are using us as examples to scare the other lawyers into line," said Jiang, who recently defended a Tibetan Buddhist cleric against charges of concealing weapons in an area of China where anti-government protests occurred.
Jiang and others said they believed the government campaign was linked to official anxiety about potential social unrest this year to mark the 20th anniversary of the June 4, 1989 pro-democracy protests.
Recent months have seen an upswing in detentions, harassment, and attacks on lawyers involved in sensitive cases. Earlier this month, Beijing lawyers Zhang Kai and Li Chunfu were detained and beaten by police in the western city of Chongqing while visiting the family of a man who died under suspicious circumstances in a labor camp.
Another Beijing lawyer, Gao Zhisheng, took on several politically charged cases including the defense of Falun Gong practitioners. He has been missing since February and is presumed to be in police custody.
"The lawyers we are talking about have shown they are not deterred by administrative or political interference or threats or physical violence," said Bequelin, the Human Rights Watch researcher.
Copyright 2009 The Associated Press.
ALEXA OLESEN
Associated Press Writer
BEIJING (AP) — China's judiciary is warning law firms to rein in lawyers who take up human rights and other politically sensitive cases, lawyers said Wednesday, increasing the pressure in a government campaign that has so far failed to curb growing legal activism.
Lawyers said authorities had met or talked on the phone with senior members of at least nine law firms in recent weeks, urging them to not seek the renewal of licenses for certain lawyers or to submit partial applications that would allow authorities to reject them on technicalities.
If carried through, the disbarments would mark the broadest effort in recent years by China's authoritarian government to rein in a growing number of activist lawyers.
"Before they used to pressure individuals but now they have turned to this more systematic method," said Tang Jitian, whose employer, the Anhui Law Firm in Beijing, was among those warned. "The justice departments say the lawyers who defend human rights are inharmonious or unstable elements, but I think they are the ones who are unstable."
The campaign will have a "chilling effect" on the Chinese legal profession even if the lawyers currently under threat manage to get their licenses back, said Nicholas Bequelin, Asia researcher for New York-based Human Rights Watch.
While lawyers have had their credentials pulled in the past, threats, beatings and other acts of intimidation have been common.
"There is a concerted effort to retaliate against lawyers who have taken some of the most sensitive cases in recent months and years," Bequelin said. "The purpose is to deter all lawyers from taking those type of cases."
Among those facing disbarment is a lawyer for a noted Tibetan Buddhist monk and others who have defended practitioners of the banned Falun Gong spiritual movement or helped parents whose children died in last year's devastating earthquake in Sichuan province. Many children were killed in schools that parents and others say were fundamentally unsafe due to corruption, cost-cutting and poor design.
The Justice Bureau did not immediately respond to a faxed request for information Wednesday about accreditation delays and allegations of intimidation.
The warnings are especially chilling because they coincide with the license renewal period for both law firms and lawyers.
Lawyers said the implicit message was that firms should sabotage the applications of their "problem lawyers," or risk having their firm's license or the licenses of other employees rejected. The easiest ways for a firm to lose an employee, without having to fire them, are to submit incomplete accreditation paperwork or an unfavorable performance review, or to simply not submit an application at all, they said.
Tang, who has defended farmers against rural land grabs and challenged police detention without trials, said if his license was not renewed by Sunday, he would be barred from working.
At least 20 other lawyers spread across nine firms have reported the same delays in getting their licenses renewed, Tang and other lawyers said.
Jiang Tianyong, a lawyer with Beijing's Gaobo Longhua Law Firm, said his application was still pending.
"They are using us as examples to scare the other lawyers into line," said Jiang, who recently defended a Tibetan Buddhist cleric against charges of concealing weapons in an area of China where anti-government protests occurred.
Jiang and others said they believed the government campaign was linked to official anxiety about potential social unrest this year to mark the 20th anniversary of the June 4, 1989 pro-democracy protests.
Recent months have seen an upswing in detentions, harassment, and attacks on lawyers involved in sensitive cases. Earlier this month, Beijing lawyers Zhang Kai and Li Chunfu were detained and beaten by police in the western city of Chongqing while visiting the family of a man who died under suspicious circumstances in a labor camp.
Another Beijing lawyer, Gao Zhisheng, took on several politically charged cases including the defense of Falun Gong practitioners. He has been missing since February and is presumed to be in police custody.
"The lawyers we are talking about have shown they are not deterred by administrative or political interference or threats or physical violence," said Bequelin, the Human Rights Watch researcher.
Copyright 2009 The Associated Press.
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