The Dix Hills doctor medical malpractice case could spark reforms at the New York State Department of Health.  State Health Commissioner Richard Daines said Tuesday that he is considering a range of institutional changes following public uproar over the state’s handling of Dr. Harvey Finkelstein, the Dix Hills doctor who exposed hundreds of patients to blood-borne pathogen infections, including Hepatitis C and B and HIV/AIDS.  Daines is looking to speed public notification, move aggressively against bad doctors, and strengthen the state’s authority to obtain medical records.  But, the proposed changes would not guarantee the public would be informed immediately simply because of the time involved in conducting these types of investigations. The commissioner said he had already initiated some changes, including establishing a team to oversee ongoing investigations to ensure they are being done in a timely fashion.

The New York State Department of Health has come under attack for taking nearly three years to advise the public about Finkelstein’s hepatitis C contamination.  It took until this November to notify just 628 of Finkelstein’s patients, urging them to get tested for hepatitis B and C and HIV.  Since then, the state has sent information to over 300 more people they determined were Finkelstein’s patients.  Daines’ boss, Governor Eliot Spitzer, called the response unacceptably slow and ordered an investigation.  By the way, state authorities are no longer trying to trace new hepatitis C cases back to Finkelstein.  Because the department has already determined a transmission occurred, its role is to simply notify the public of the risk.  The onus is on infected patients to determine where they contracted the virus and whether they have claims against a physician.

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CT Scan overuse could be putting many people at an increased risk for developing cancer, a new study says.  The findings regarding the CT Scan – cancer link are disturbing, especially as they come on the heels of other research that found pregnant women are now being exposed to twice as much radiation through CT Scans as they where just a few years ago. In addition to putting these women at risk of developing cancer in the future, increased radiation exposure through CT Scans could put their babies at risk for serious diseases.

CT Scans, also called CAT Scans, produce three-dimensional x-ray images of the body that can be quickly taken in multiples and be displayed on a screen.  Diagnosticians favor CT Scans because they can reveal abnormalities that are too small or obscured to be seen by more traditional x-rays.   CT Scans have proven to be particularly useful in diagnosing trauma and cancer patients.

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Serevent, a top selling asthma drug, needs stronger safety warnings, a Food & Drug Advisory (FDA) panel said yesterday.  The FDA panel’s Serevent recommendation came after five children died while using the drug.  If adopted, the new warnings could have serious implications for Serevent sales, and for those of another GlaxoSmithKline asthma medication, Advair.   Serevent is an active ingredient in Advair.

Serevent and Advair are inhalation powders used to prevent asthma attacks.  Asthma is a chronic lung disease that causes inflammation and narrowing of the airways in the lungs.   Asthma attacks cause shortness of breath, cough, chest pain and other symptoms.  Serevent and Advair contain long-acting beta 2-adrenergic agonists that prevent the release of substances in the body that cause inflammation of airways in the lungs.  Both Serevent and Advair are used to prevent asthma attacks, and do not work if an asthma attack has already begun. Advair and Serevent are also used to treat chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis.

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Post-Traumatic Stress Disorder (PTSD) is associated with an elevated prevalence of asthma, says a new study in The American Journal of Respiratory and Critical Care Medicine.  The link between PTSD and asthma existed even after adjusting for factors such as cigarette smoking, obesity, and socioeconomic placement.  Researchers state that efforts to understand this co-morbidity may help in identifying modifiable environmental risk factors and in developing more effective prevention and intervention protocols for the future.

The study involved 3,065 male twin pairs-both identical and fraternal-who lived together in childhood and had both served on active military duty during the Vietnam War.  Both identical and fraternal twins were included, with similar findings, so genetic influences for the results were ruled out.  Also, factors such as cigarette smoking, obesity and socioeconomic status had no appreciable effect on the findings

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Provigil, a drug used to treat excessive sleepiness, should bear a stronger warning on its label that the medication is not approved for use in children under the age of 16, a Food & Drug Administration (FDA) panel said yesterday.  While Provigil, manufactured by Cephalon, is not approved for use in children, it has been prescribed to treat a variety of conditions in kids quite frequently.

Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. However, it is known that doctors also prescribe Provigil for a number of off-label uses in both adults and children.  In many cases, Provigil is used in the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression. It is estimated that as much as 90% of all Provigil prescriptions are written for off-label use. Such off-label use is not illegal, as doctors are free to prescribed approved drugs in any way they see fit. However, drug companies are not allowed to market a medication based on off-label use. In 2004, Cephalon was investigated for allegedly promoting off-label uses for Provigil.

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The value of Famvir, a genital herpes treatment cold sores and shingles, was fraudently inflated by Novartis, charges an ex-employee of the company.  Former Norvatis brand director Carol Shull alleged in her lawsuit-filed in New Jersey state court-that she was wrongfully terminated.  Shull claimed she was fired this past March after complaining repeatedly for nearly two years about attempts by the drug maker to falsely overstate the value of Famvir on its books.  The Swiss company Novartis acquired the drug for $1.6 billion back in 2000, but the lawsuit asserts that Novartis managers knew they overpaid and the investment would never be recovered.  Official comment is pending from Novartis.

The attorney for the Novartis whistleblower states that as a direct result of her objection and refusal to participate in activities she believed were fraudulent and in violation of the law and public policy, Shull suffered retaliatory action by being wrongfully discharged.

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Toxic mold exposure can cause serious health problems as the residents of a Long Island luxury apartment building recently found out. This week, the 21-building Westbury community on Corporate Drive is being cleared of all residents in nearly 400 apartments following reports of mold- and mildew-infested buildings.  Archstone-Smith-a Colorado-based company that developed and manages the complex-discovered catastrophic water damage and must serve formal lease termination notices to residents who will need relocate by March 31, 2008.  Residents, who say they’ve been reporting water problems to Archstone-Smith since 2005, called the situation outrageous and disgusting, saying they’ve endured leaky windows and grotesque mold in their home.  Many report that they have been sickened with respiratory ailments.  Building managers considered these isolated problems until an increase in complaints following this year’s rains.

Concentrated mold exposure can cause chronic cough, headaches, rashes, dizziness, excessive bruising, and hearing and memory loss.  Black or toxic mold-Stachybotrys chartarum-is pathogenic, produces spores called mycotoxins, and can inhibit DNA and protein synthesis in mammalian cells, obstructing body functions.  Toxic mold severely sickens people and pets and is a leading cause of “sick building syndrome.”

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A Sheetz Salmonella lawsuit has been settled in Pennsylvania for an undisclosed amount.   The lawsuit, filed by Max Christian Anslinger of Altoona, Pennsylvania, was a notable case among the many claims filed over the Salmonella tainted tomatoes served at some Sheetz locations. According to Associated Press reports, it was through the Anslinger lawsuit’s discovery process that an attempt was made to determine where exactly the Sheetz Salmonella contaminated tomatoes came from.

The Sheetz tomato Salmonella outbreak occurred in 2004, when more than 500 people in 5 states, including Pennsylvania, Maryland, Ohio, West Virginia, and Virginia were sickened by tomatoes served on sandwiches sold at the convenience stores.  Salmonella bacteria cause diarrhea, abdominal cramps, and fever within 72 hours of exposure. Children, the elderly or people with weakened immune systems are especially vulnerable to complications from Salmonella poisoning. In rare cases, extreme instances of Salmonella poisoning can lead to a disease called Reiter’s Syndrome, which is associated with chronic arthritis. According to the Centers for Disease Control (CDC), Salmonella bacteria sicken 40,000 people every year. Although the true number could be much higher, because it is estimated that for every case of Salmonella poisoning reported, two others are unreported.

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Ketek users injured by the defective drug have filed suit against Sanofi-Aventis in Illinois.  The 47 plaintiffs involved in the Ketek lawsuit claim that Sanofi-Aventis knew that Ketek put users at an increased risk of increased risk injuries or death from liver failure and hepatic injury.

Ketek, a powerful antibiotic, was approved by the Food & Drug Administration (FDA) in 2004 to treat sinus infections. This approval came despite serious concerns with the way clinical trails of Ketek had been conducted. Because cheaper antibiotics, like amoxicillin, were already available to treat sinus infections, the FDA required Aventis to design a study showing that Ketek would work at least as well as existing treatments before it could be approved. Aventis eventually signed up 1800 private physicians to participate in these clinical trails. These doctors were given $400 for every patient they convinced to participate in the Ketek study. That huge financial incentive was too much for some doctors to resist. When the FDA audited Ketek study participants, they found one family doctor in a small Alabama town had signed up 407 patients for the study.  The doctor’s entire staff was enrolled in the trail. It even appeared that some of the patient signatures on consent forms where forged. That Ketek Clinical trial doctor was eventually convicted of fraud and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one.  In October, the FDA issued Sanofi-Aventis a warning letter for failing to respond to problems with Ketek clinical trials.

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Tykerb promotional letters sent to doctors by GlaxoSmithKline have drawn the ire of regulators at the Food & Drug Administration (FDA).  The Tykerb promotional materials led the FDA to issue Glaxo a warning letter that criticized the company for hyping the breast cancer drugs’ benefits while failing to mention its harmful side effects.

Approved by the FDA in March 2007, Tykerb is a once daily pill taken in conjunction with chemotherapy to treat advanced, metastasized breast cancer.  Tykerb is indicated for women with HER2-positive breast cancer that does not respond to standard treatment, including the other HER2-specific drug, Herceptin.

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