"The data in this report provides additional, strong evidence of the serious harm related to tobacco," said Sherri Stewart of the CDC's Division of Cancer Prevention and Control, who led the study.  Stewart's team reviewed cancer surveys and registries covering 92 percent of the U.S. population.

The study revealed that Kentucky had the highest rates of lung cancer among men and women, while Western states with low rates of smoking also had low cancer rates.  Tobacco-related cancers were more common among blacks, non-Hispanic whites and men, reflecting the groups that use tobacco more, the CDC found.

"Tobacco use is the leading preventable cause of disease and premature death in the United States and the most prominent cause of cancer," said the CDC's Dr. Matthew McKenna.  "The tobacco-use epidemic causes a third of the cancers in America," McKenna added.  The CDC reports that tobacco use kills 438,000 people prematurely every year, including 38,000 people do not smoke, but suffer the effects of secondhand smoke.  "Tobacco use causes more deaths each year than alcohol use, car crashes, suicide, acquired immunodeficiency syndrome (AIDS), homicide, and illegal drug use combined," the report reads.  "In addition, smoking accounts for $167 billion annually in health care expenditures and productivity losses."

Cancer is not the only serious health concern that cigarette smoking and secondhand smoke cause.  Experts have long known that children are particularly susceptible to the harmful effects of secondhand smoke and that such exposure either prenatally or early in life can raise a child's risk of developing asthma symptoms, and, now, allergies.  Secondhand smoke exposure causes respiratory symptoms in children and slows their lung growth and causes sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more frequent and severe asthma attacks in children.  It has also long been believed that prolonged exposure to secondhand smoke can cause lung damage and emphysema.

In the past, doctors lacked a way to prove this and previous detection methods simply weren’t sufficiently sensitive, but ew technologies have enabled researchers to confirm that long-term exposure to secondhand smoke can cause structural damage in the lungs, indicative of emphysema.  In recent years, secondhand smoke has emerged as a public health threat, being classified as a carcinogen by the Environmental Protection Agency and linked to heart disease, lung cancer, and a number of respiratory ailments, including asthma and chronic bronchitis. According to the American Lung Association, 35 percent of American children live in homes where regular smoking occurs.  Also, smokers have a higher risk of developing several chronic disorders including atherosclerosis, several types of cancer, and chronic obstructive pulmonary disease.

According to an FDA spokesman, orthopedic device manufacturers would benefit from the program because it would “offer more timely, comprehensive assessment of the ‘real world’ experience of their devices and an alternative means to conduct mandated post-approval studies.”  Nevertheless, some caution that such a government-run registry might have too many limitations, given the current budget and resource restrictions plaguing the agency. “One of the challenges the FDA and other agencies face is being able to devote resources in a continuing way.  And our view is that registries will bring up more questions than answers,” David Lewallen, chairman of the American Academy of Orthopaedic Surgeons’ (AAOS) American Joint Replacement Registry Oversight Board and head of the American Association of Hip and Knee Surgeons, said. “It wouldn’t be impossible to do it through a government-run agency, but it is a bigger challenge.”

Another consideration is patient confidentiality. “Unless there are some safeguards in place, people would be wary of a federal-run system.  It may even discourage some people from reporting adverse events,” Lewallen said.  Meanwhile, hundreds of patients who received the Zimmer Durom Cup hip implants in the U.S. experienced serious adverse reactions.  Since, a prominent surgeon went public with his concerns and patient advocates have been calling for the creation of a national database—a joint registry.  Advocates argue that such a system would quickly alert doctors and federal regulators to devices with high failure rates, possibly sparing tens of thousands of patients from severe, painful injuries.

Last year, Dr. Lawrence Dorr, a highly experienced orthopedist and Zimmer consultant, noticed that within months of implantation, many of his patients were suffering from crippling pain.  X-rays revealed that the Durom socket was separating from the bone, not fusing with it, which required additional, excruciating replacement surgery.  Zimmer ignored Dorr and attempted to blame him for the defect, but eventually, Zimmer conducted an investigation and suspended sales of the defective component.  Critics argue that it never should have taken so long and, in many countries where joint registries are in place, it would not have.  If the U.S. had such a database, Zimmer might have been forced to take the Durom Cup off the market much sooner.

Some critics believe a more sinister force is responsible for long blocking implementation of a joint registry; specifically the financial arrangements between implant makers and many orthopedic surgeons.  Some physicians might be reluctant to report problems with a device if they are receiving compensation from its manufacturer.  This would not be the first time surgeons were influenced by the payments they receive from implant makers.  Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $310 million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products.

The complaint’s causes of action include strict product liability-failure to warn and defect in design or manufacture, fraud, breach of implied and express warranties, negligence and gross negligence.  The 10 companies named as defendants are:  Mylan Inc., Mylan Bertek Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Actavis Mid Atlantic, Morton Grove Pharmaceutical Inc., Taro Pharmaceuticals USA Inc., VistaPharm Inc., Barr Pharmaceuticals Inc., Ivax Pharmaceuticals Inc., Elkins-Sinn Inc., Hospira Inc., Hospria Worldwide Inc., and Baxter Healthcare Corporation.

The suit also states that Davis began taking phenytoin in June 2006.  Sometime later, Davis broke out with a high fever and skin rash that resulted in blisters on her face and body.  Davis was then hospitalized for several weeks at the Medical Center of Southeast Texas where she was diagnosed with Stevens-Johnson Syndrome.  According to MayoClinic.com, Stevens-Johnson syndrome is a rare, serious disorder of the skin and mucous membranes and often presents with several days of flu-like symptoms, followed by inflammation of the mucous membranes, and a painful red or purplish rash that spreads and blisters, eventually causing the top layer of the skin to die and shed.  The syndrome is usually a specific type of allergic reaction in response to medication or infection, according to the Mayo Cinic’s Website.

The plaintiffs allege that the defendants violated the applicable code of federal regulations by failing to include a warning that Stevens-Johnson Syndrome is a potential side effect of phenytoin.  "Accordingly, Ms. Davis' prescribing physician was deprived of the ability to fully assess the risks when making the decision to prescribe the drugs due to the defendants deficient and inadequate warning," the complaint states.  The plaintiffs also claim that Davis would not have taken phenytoin had the risks and dangers been disclosed, and "would not have suffered her adverse reaction and its subsequent complications."

The complaint states that because the drug hazards were hidden, the drug makers “have reaped huge profits"; that the defendants failed to perform adequate testing that would have shown that phenytoin possessed serious side effects; that the defendants should have taken appropriate measures to ensure that its defectively designed product would not be placed into the stream of commerce; that prior to manufacturing and distributing the drug, the companies "had knowledge from several sources" that the product presented substantial and unreasonable risks to the consumer; that the drug makers knowingly and deliberately failed to remedy the known defects "for the purpose of increasing sales and enhancing its profits"; and that “Defendants' conduct was wanton and willful, and displayed a conscious disregard for the safety of the public and particularly of Ms. Davis, entitling her to exemplary damages."

Simvastatin is a statin, a class of drugs which already carries a risk of rhabdomyolysis.  However, the FDA said today that the risk of developing rhabdomyolysis is more pronounced when simvastatin is combined with amiodarone than it is with other statin medications.

Rhabdomyolysis is a muscle injury that causes the rapid breakdown of skeletal muscle tissue.  The destruction of the muscle leads to the release of the breakdown products of damaged muscle cells into the bloodstream; some of these, such as myoglobin, are harmful to the kidney and may lead to acute kidney failure.  

According to today's FDA warning, the risk of developing rhabdomyolysis is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone.  The agency said that healthcare professionals, who prescribe simvastatin or simvastatin-containing medications (Simcor, Zocor, Vytorin), should be aware that patients taking amiodarone should not take more than 20 mg per day of simvastatin.

Patients starting therapy with simvastatin, or who have had their dose of simvastatin increased, should contact their doctor immediately if they  experience symptoms of unexplained muscle injury, such as muscle cramps, pain, tenderness, stiffness or spasm.

The FDA said it is working with the manufacturer of Cordarone (amiodarone) to modify prescribing information to warn of an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses exceeding 20 mg daily. In 2002, the labeling of simvastatin was changed to include similar information.

Dr. Alexander Kallen of the CDC led the study and confirmed that some patients died within four days and many were not initially treated for MRSA, suggesting their doctors did not know that they were dealing with MRSA-provoked pneumonia. "It's obviously very concerning," Kallen said. "This is a disease that can strike otherwise very healthy people—adults and children.  Also, this is a disease that follows influenza."  Kallen also indicated that the disease has implications for preparing for the flu season and a possible flu pandemic.

Kallen’s team reviewed reports of community-acquired pneumonia caused by Staph aureus between November 1, 2006 and April 30, 2007 and found that, "Overall, 51 cases were reported from 19 states."  Their findings appear in the Annals of Emergency Medicine.  "More than three-quarters—79 percent—of the staph-caused pneumonia patients were infected with MRSA," Kallen said.

The patients’ average age was 16.  One-third had confirmed influenza; however, nearly half—40 percent—were healthy.  According to the researchers, 24 patients died within an average of four days following a pneumonia diagnosis. Those infected with the flu were about twice as likely to die from the staph-caused pneumonia.  "The key message to realize is that during the winter season, especially when influenza is circulating, physicians need to be thinking about this as a cause."

Staph aureus is common and generally about 30 percent of all people are colonized with staph at any given time.  This means that these people have the staph bacteria living on their skin or in their noses, but are not ill.  "You shake hands with someone and you get MRSA and MRSA colonizes you," Kallen said.

Staph can get into the lungs and cause disease and some studies indicate that when people are infected with flu, the virus can help shut down the natural processes for ensuring the lungs clear, thus allowing the staph bacteria to grow in the lungs.

In April we reported a disturbing increase in the number of children dying from both the flu and MRSA.  At that time, state and federal disease investigators began tracking the situation and Massachusetts’s health authorities linked two childhood flu deaths to MRSA and found that nationally, of 74 children known to have died from the flu in the US in 2006-07, 22 also had staph, most MRSA.  The CDC expressed deep concern and began planning on executing a monitoring network for patients co-infected with flu and MRSA during the next flu season.  Experts say that data and other findings could assist doctors in preventing flu-MRSA cases from turning fatal.