A contaminated Sierra Pre-Filled Syringe made a leukemia patient seriously ill, and now she is suing the maker of the defective devices.  The 30-year-old Illinois woman reportedly spent 9 days in the hospital as a result of the bacterial infection she contracted from the Sierra Pre-Filled Heparin Syringe she used as part of her home treatment.  Late last week, the tainted Sierra Pre-Filled Syringes where pulled from the market after dozens of blood infections where traced to them.

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Doctors at Rush were able to trace the infections to heparin-filled Sierra Pre-Filled Syringes the patients used during home treatment for cancer and other ailments.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  The infections were caused by bacterium called Serratia marcescens found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled.  Serratia marcascens generally causes fever, chills and vomiting, but responds well to antibiotics.  However, in cancer patients, the blood infection can be much more serious because the immune systems of such patients are already compromised.  In such cases, infections caused by the bacteria could be life-threatening.

More Sierra Pre-Filled Syringe Lawsuit Filed in Illinois, and More are Expected to Follow

Maine can no longer keep the prescription writing habits of the state’s doctors secret. A federal judge just ruled that a new Maine law making doctors’ prescription-writing habits confidential violates the Constitution. 

U.S. District Judge John Woodcock concluded that the law—which was scheduled to take effect January 1, 2008—would prohibit “the transfer of truthful commercial information” and “violate the free speech guarantee of the First Amendment.” The law had been challenged by IMS Health of Norwalk, CN, Wolters Kluwer Health of Conshohocken, PA, and Verispan of Yardley, PA, organizations which collect, analyze, and sell medical data to pharmaceutical companies, government agencies, and researchers. The companies said the law would prevent the health care community from monitoring the safety of drugs and make it difficult to track defective drugs. Backers of the measure say it is one of several laws passed by Maine legislators that aim to address high health care and prescription drug costs. In a decision issued Friday, Woodcock said he relied heavily on an April 30th ruling by U.S. District Judge Paul Barbadoro in New Hampshire that rejected a similar law in which Barbadoro cited unconstitutional free speech restrictions—the decision was appealed in the 1st U.S. Circuit Court of Appeals in Boston. A similar case is also pending in Vermont. The primary sponsor of Maine’s legislation, Democratic Representative Sharon Treat, said she was disappointed with the ruling and anticipates an appeal.

The suit originated in August in Maine and Vermont federal courts challenged laws making doctors’ prescription-writing habits confidential and asked the court to block the states from enforcing their laws, saying the statutes are unconstitutional and citing violations of the 1st Amendment by barring transfer of lawfully obtained information and the 14th Amendment by impeding interstate commerce. At that time, Maine Attorney General Steven Rowe said the suit was not a surprise, given the legal challenge in New Hampshire, adding, “We will vigorously defend the constitutionality of the law and oppose efforts to have its enforcement enjoined.

More Maine Prescription Drug Secrecy Law Doesn’t Pass Constitutional Muster, Court Says

Sierra Pre-Filled Heparin Syringes have been recalled by the Food & Drug Administration (FDA) after it was discovered that the medical devices were contaminated with dangerous bacteria.  The Centers for Disease Control and Prevention (CDC) is also investigating dozens of blood infections linked to the Sierra Pre-Filled Syringes contaminated with bacteria.  In announcing the Sierra Pre-Filled Syringe recall, the FDA said that an ongoing inspection of Sierra Pre-Filled showed that the firm is “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes”.

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Although all responded quickly to antibiotic treatment, one patient remains hospitalized as of Tuesday, said Dr. John Segreti, hospital epidemiologist.

More Sierra Pre-Filled Heparin Syringes Recalled After FDA Inspection Finds Problems with Company’s Quality System

A New Haven pediatrician was reprimanded for medical malpractice, after “diagnosing” and “treating”  Lyme disease over the phone.  Dr. Charles Ray Jones was fined $10,000, and placed on two years probation by Connecticut state regulators this week.  The Connecticut Medical Examining Board voted unanimously to impose sanctions when they confirmed that  the 77-year old New Haven doctor violated care standards by diagnosing Lyme disease in two children and prescribing antibiotics based on a phone conversation with their mother, months before examined them.  The board found Jones broke standards by failing to reconsider his diagnoses of the children when lab tests results were negative for the tick-borne disease and that Jones was wrong to prescribe antibiotics for nearly a year without repeat exams and with no arrangements with another doctor—the patients live out of state, in Nevada—to monitor side effects and results of long-term antibiotic therapy.

Jones’s lawyer, Elliott Pollack, said he will appeal the board’s decision adding, “This board has made a very serious error without sufficient evidence and contrary to compelling evidence,” saying the board’s ruling was “a classic example of government treading where it’s not ready to tread.”  Pollack compared Jones to other “nonconformists” ostracized by the medical community before having their innovations validated.  Jones, who says he has treated over 10,000 children with Lyme disease, insists long-term antibiotics are the best remedy and believes doctors fail to diagnose Lyme disease because patients don’t have what the medical establishment says are the telltale symptoms:  Rash and achy joints.  Jones says under 10% of Lyme patients have the rash when seen by a doctor.

More Connecticut Pediatrician Sanctioned for Lyme Disease Malpractice

Whooping cough—or pertussis, a bacterial respiratory infection—considered a disease of a bygone era is making a comeback.  Outbreaks of whooping cough in four states of the sometimes-fatal disorder, despite mandatory vaccinations for children of school age, public health officials said Wednesday. 

Whooping cough is a highly infectious condition marked by an unstoppable urge to cough.  “Just as we have been reminded that tuberculosis is still with us, we are seeing the reemergence of pertussis, a bacterial respiratory infection,” said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in Manhattan. “Children who have not been adequately vaccinated with the standard DPT vaccine are at risk, as are adults whose immunity to the bacterium may have faded over decades.”

Although the number of cases this year is lower than in 2006, most occurred within the past several weeks with outbreaks in Pennsylvania, South Carolina, Wisconsin, and Ohio; a Colorado baby died last month after coughing to death.  Cases this year have been at their lowest nationwide since 2000, at only 8,051; however, doctors do not believe pertussis has been completely removed.  There were only 1,010 cases nationwide in 1976 that range is now seen yearly in New York state alone. 

Although New York is not among states experiencing an outbreak, the number of pertussis cases in recent years has ranged from a low of 450 in 2002 to a high of 1,969 in 2005.  There were 1,091 confirmed cases last year—the most recent year for complete statistics—said Jeffrey Hammond, spokesman for the New York State Health Department. 

Nationally, the number of cases so far this decade has been as high as 25,800, according to statistics from the Centers for Disease Control and Prevention (CDC).  “It has made a comeback, but the recognition of the disease is better and our ability to diagnose and treat it is also better,” said Dr. Thomas Clark, a CDC medical epidemiologist. 

He said the pertussis bacterium produces a toxin, which accelerates the formation of thick mucus in the lungs that, in turn, causes an uncontrollable urge to cough.  “The incidence of pertussis waxes and wanes in cycles, mostly on the order of three to four-year cycles,” Clark said.

More Whooping Cough Makes a Comeback

The rejection of Provenge by the Food & Drug Administration (FDA) has some in Congress crying foul.  Shares of the Dendreon Corporation jumped sharply Thursday after lawmakers called for hearings to investigate the rejection of the company’s experimental prostate cancer drug, Provenge.  Dendreon rose from $1.34, to $6.98 and the stock almost tripled after a panel of advisers recommended that the FDA approve the treatment; the agency rejected Provenge in May.  While the FDA pointed to concerns about its potential side-effects and effectiveness, two Congressmen are concerned that one FDA advisor’s connections to competing pharmaceutical company could have doomed its approval.

Representatives Dan Burton, Michael H. Michaud, and Tim Ryan said they wanted an inquiry into potential conflicts of interest for two members of the advisory panel who had argued against approval of Provenge.  “There is reason to believe that serious ethics rules were violated” by the two advisers, the lawmakers wrote in a letter.   Dendreon won a 13-to-4 vote in favor of Provenge at the meeting of cancer advisers to the FDA in March.  While the agency usually follows the advice of its panels, it said on May 9 that Dendreon would have to produce results from another study to win approval.  Dendreon lost almost $1 billion in market value.

More Provenge FDA Rejection Sparks Call for Investigation Amid Conflict-of-Interest Concerns

Phosphates, toxic substances used in a great number of household products, are causing untold environmental damage.  The Canadian federal government is considering banning phosphates in a wide variety of household and industrial products.  Environment Canada plans to hire experts to analyze the socioeconomic and environmental impacts of proposed new restrictions on phosphates and the government has set aside nearly $68,000 for the study.  Consultants will examine possible control scenarios, including a total ban on phosphorus in detergents and cleaning products and will issue a report by next May.  Manitoba and Quebec have announced plans to limit phosphate concentrations in dishwasher detergents to 0.5 per cent by 2010 and have called on Ottawa to do the same.

“When someone puts soap in their dishwasher in Edmonton, that makes its way into Lake Winnipeg,” Manitoba Water Stewardship Minister Christine Melnick said Monday.  “We really need the sort of inter-jurisdictional co-operation that a national strategy would bring about.”  Ms. Melnick welcomed news of the federal study, saying federal Environment Minister John Baird, who was unavailable to comment Monday, has been non-committal on the issue.

More Phosphate Ban Gains Steam in Canada

NSF (Nephrogenic Systemic Fibrosis), sometimes called NFD (Nephrogenic Fibrosing Dermopathy) is a rare disease that so far has affected only people with pre-existing kidney problems.  In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since that initial discovery, several other studies have reinforced the link between NSF and Gadolinium MRI contrast dyes.  In 2006, the Food & Drug Administration (FDA) first warned doctors of this Gadolinium side effect.  Then, in 2007 the FDA ordered the manufactures of Gadolinium contrast dyes to add a black box warning – the strictest type of FDA warning — to their product labels advising of the risk of NSF to people with kidney problems.

NSF was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

More Evidence of Gadolinium MRI Contrast Dye Link to NSF Stronger than Ever

The illegal dumping of toxic animal waste, usually from factory farms, can inflict serious environmental damage, especially to water supplies.  Yet over the past several ears, the Environmental Protection Agency (EPA) has been loosening animal waste disposal standards for livestock producers.  The most recent example of lax EPA regulation is the agency’s announcement today that it is proposing a rule change to provide an administrative reporting exemption for air releases of hazardous substances — primarily ammonia and hydrogen sulfide — from animal waste at farms.

According to website maintained by the Sierra Club, America’s drinking water, rivers and lakes are at risk from giant, corporate-owned factory farms.  These farms produce a staggering 500 million tons of animal waste per year.  Very often, this animal waste is allowed to leak into rivers and streams, fouling the air, contaminating drinking water and spreading disease. According to the Environmental Protection Agency, hog, chicken and cattle waste has polluted 35,000 miles of rivers in 22 states and contaminated groundwater in 17 states. In the past couple of years, several large food poisoning outbreaks related to tainted vegetables have been blamed on run-off fouled by animal waste making its way into tomato, spinach and lettuce fields.

More Animal Waste Dumping Reporting Requirements for Farms Eased by EPA

Basil is just the latest food subject to a recall amid Salmonella fears.  The basil recall involves some 5,500 pounds of basil grown in Mexico and sold in the United States under the “Green Paradise” label, a spokesman for the importer said Thursday.  The recalled basil was imported from a farm in Mexico’s southern Baja California region on December 5th and sold to food distributors in Southern California, Texas, and Illinois the next day, said Alberto Martinez, a spokesman for Los Angeles-based importer Top Line Specialty Produce.  The Southern California distributor sold the Salmonella tainted basil to restaurants and other food service customers, but it was unknown whether the other distributors sold to food service customers or retailers, he said.  No Salmonella illnesses have been reported in relation to the Green Paradise basil recall.

The basil recall was issued after U.S. Food and Drug Administration (FDA) inspectors detected the possible Salmonella contamination during a random check when the basil passed over the Otay Mesa border crossing in to San Diego County, Martinez said.  Top Line continued to import basil and other herbs from the Green Paradise farm in the Los Cabos area where the potentially contaminated product was grown, processed, and bagged. When the FDA alerted the company about its inspection results on Tuesday, the company immediately stopped imports from that farm and issued its recall on Wednesday, Martinez said.

More Salmonella Concerns Spark Green Paradise Basil Recall