Spectranetics Pays $5 Million To End Federal Investigation

USA Today

Spectranetics (SPNC) said Wednesday it will pay $5 million to end a government investigation into allegations it imported and marketed medical lasers that had not been cleared by regulators.

The U.S. Department of Justice said Spectranetics illegally imported the devices and marketed them for purposes that had not been approved by the Food and Drug Administration, which led to false claims being filed with Medicare between 2003 and 2008. It also said a Spectranetics clinical trial called CORAL did not meet federal standards.

The Colorado-based company agreed to pay $4.9 million to resolve the investigation, which began in 2008, and will forfeit another $100,000 in cash or property in the near future. The Justice Department said Spectranetics is cooperating with the investigation, but the agreement means the company will avoid prosecution. Spectranetics accepted responsibility for its conduct and instituted safeguards in response, the Justice Department said.

Spectranetics did not immediately return requests for comment.

The CORAL study evaluated lasers as a treatment for arterial plaque. The government said a second study also did not meet regulatory requirements. Products involved included the CVX-300 medical laser and the CliRpath turbo laser catheter, the TURBO elite laser ablation catheter, and the TURBO-Booster laser guide catheter.

In September 2008, the Food and Drug Administration and U.S. Immigration and Customs Enforcement served Spectranetics with a search warrant to get information related to the marketing, use and testing of a product, and payments to medical personnel. They also sought details of catheter guidewires and balloon catheters made by other companies, two post-market studies, and compensation packages for personnel.

Spectranetics shares jumped to an annual high on the news, rising 81 cents, or 13%, to $6.85. The stock peaked earlier at $7.77, its highest price since Sept. 4, 2008, the day the investigation was disclosed.

Tylenol Issues Voluntary Recall Of Arthritis Caplet

Business Week

Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

According to a statement posted to the Food and Drug Administration Web site on Tuesday, the New Brunswick, N.J., company is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.

Johnson & Johnson had recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea.

The health care company said the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.

To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The recall only affects the specific lots cited. All other Tylenol Arthritis pain products remain available.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

Consumers seeking a refund or replacement of the arthritis medication can call J&J at 1-888-222-6036.

Company shares rose 45 cents to $65.39 in morning trading Tuesday.

Vivus Requests FDA Approval For Obesity Drug

LA Times

Drugmaker Vivus Inc. said Tuesday it asked regulators to approve its drug candidate Qnexa as a treatment for obesity.

Vivus said it has filed a new drug application with the Food and Drug Administration. A week ago, competitor Arena Pharmaceuticals Inc. said it filed for approval of its own experimental obesity drug, lorcaserin. Orexigen Therapeutics plans to request marketing approval for its product Contrave32 in the first half of 2010.

Vivus reported positive results from two late-stage clinical trials of Qnexa in September. Qnexa, lorcaserin and Contrave32 could all reach the market around the same time, and some analysts say they believe Qnexa could be the top seller of the group based on the weight loss observed in clinical testing.

In morning trading, Vivus shares rose 17 cents to $9.84.

Dogs Excel At Sniffing Out Cancer

NY Times

In the small world of people who train dogs to sniff cancer, a little-known Northern California clinic has made a big claim: that it has trained five dogs - three Labradors and two Portuguese water dogs - to detect lung cancer in the breath of cancer sufferers with 99 percent accuracy.

The study was based on well-established concepts. It has been known since the 80's that tumors exude tiny amounts of alkanes and benzene derivatives not found in healthy tissue.

Other researchers have shown that dogs, whose noses can pick up odors in the low parts-per-billion range, can be trained to detect skin cancers or react differently to dried urine from healthy people and those with bladder cancer, but never with such remarkable consistency.

The near-perfection in the clinic's study, as Dr. Donald Berry, the chairman of biostatistics at M. D. Anderson Cancer Center in Houston, put it, "is off the charts: there are no laboratory tests as good as this, not Pap tests, not diabetes tests, nothing."

As a result, he and other cancer experts say they are skeptical, but intrigued. Michael McCulloch, research director for the Pine Street Foundation in Marin County, Calif., and the lead researcher on the study, acknowledged that the results seemed too good to be true. (For breast cancer, with a smaller number of samples, the dogs were right about 88 percent of the time with almost no false positives, which compares favorably to mammograms.)

"Yes, we were astounded, as well," Mr. McCulloch said. "And that's why it needs to be replicated with other dogs, plus chemical analysis of what's in the breath."

He is applying for National Science Foundation grants to try just that, he said. The fact that the study was carried out by a clinic supported by the Pine Street Foundation that combines traditional chemotherapy with acupuncture and herbal medicine raised suspicions, as did the fact that it is to be published by a little-known journal, Integrative Cancer Therapies. (The journal published it online last year.)

But experts who read the study could not find any obvious fatal flaw in its methodology, and the idea that dogs can detect cancer is "not crazy at all," said Dr. Ted Gansler, director of medical content in health information for the American Cancer Society. "It's biologically plausible," he said, "but there has to be a lot more study and confirmation of effectiveness."

Dr. Berry, too, was interested but suspicious. "If true, it's huge," he said. "Which is one reason to be skeptical."

Dr. Berry noted, half-jokingly, that Gregor Mendel, the 19th-century discoverer of the laws of genetics, also reported data on his crossbreeding of green and yellow peas that was too good to be true: he repeatedly came up with the perfect 3-1 ratios he predicted. "But we've forgiven Mendel and his gardener," Dr. Berry added, "because his theory turned out to be right."

In Mr. McCulloch's study, the five dogs, borrowed from owners and Guide Dogs for the Blind, were trained as if detecting bombs. They repeatedly heard a clicker and got a treat when they found a desired odor in many identical smelling spots.

The clinic collected breath samples in plastic tubes filled with polypropylene wool from 55 people just after biopsies found lung cancer and from 31 patients with breast cancer, as well as from 83 healthy volunteers.

The tubes were numbered, and then placed in plastic boxes and presented to the dogs, five at a time. If the dog smelled cancer, it was supposed to sit.

For breath from lung cancer patients, Mr. McCulloch reported, the dogs correctly sat 564 times and incorrectly 10 times. (By adjusting for other factors, the researchers determined the accuracy rate at 99 percent.)

For the breath from healthy patients, they sat 4 times and did not sit 708 times.

Experts who read the study raised various objections: The smells of chemotherapy or smoking would be clues, they said. Or the healthy breath samples could have been collected in a different room on different days. Or the dogs could pick up subtle cues - like the tiny, unintentional movements of observers picked up by Clever Hans, the 19th-century "counting horse," as he neared a correct answer. But Mr. McCulloch said cancer patients who had begun chemotherapy were excluded, smokers were included in both groups and the breath samples were collected in the same rooms on the same days. The tubes were numbered elsewhere, he said, and the only assistant who knew which samples were cancerous was out of the room while the dogs were working.

"The fact that dogs did this is kind of beside the point," he said. "What this proved is that there are detectable differences in the breath of cancer patients. Now technology has to rise to that challenge."

The next step, he said, will be to analyze breath samples with a gas chromatograph to figure out exactly which mixes of chemicals the dogs are reacting to.

Even if the dogs are accurate in repeat experiments, Dr. Gansler of the American Cancer Society said, it will be useful only as a preliminary scan. "It's not like someone would start chemotherapy based on a dog test," he said. "They'd still get a biopsy."

Not All Generics May Be Equal To Brand Name Drugs

Vitals.com

The Generic Pharmaceutical Association’s slogan is “Same Medicine, Same Results.” Unfortunately this is not always the case, according to an article in the New York Times.

Patients, doctors and everyone else are all in agreement over the value of generic drugs. Not only do they save Americans 10 billion dollars a years, make medication accessible to those who need it, but also force down the price of brand name drugs.

“For many drugs, generics are just fine,” says Dr. Kimford Meador, a professor of neurology at Emory University.  “But when you are taking a seizure medication…If the absorption of the drug is slightly different between brand and generic then the patient could have a seizure and that seizure could lead to serious injury or perhaps death.”

although both products released the same amount of the active ingredient over 16 hours, the generic version released almost half of its medication after four hours and the brand name only one-quarter

According to Vitals.com, Dr. Meador completed his medical degree and residency at the Medical College of Georgia School of Medicine.

The FDA ensures the public that to be marketed in the United States these drugs must “bioequivilant” to their brand name equivalents, meaning the same doses of the same active ingredient is delivered in the same way according to the same standards of quality.

But some specialists worry that the allowable range is too wide, especially for patients taking medication to control problems like arrhythmias or seizures. Studies that were published in the journal Neurology, reported patients who switched to generics products had more seizures and higher hospitalization rates

Kathleen Jaeger, president of the Generic Pharmaceutical Association, sees this controversy as a propagandist plot masterminded by brand name drug companies. But doctors and psycho pharmacologists believe the FDA is ignoring the reality that in certain cases generic drugs can create serious problems for patients.

“If a patient with heart arrhythmia gets a blood thinner for which the levels are too low there is a risk for stroke and if the levels are too high it could result in bleeding,” says Dr. James A. Reiffel, a cardiologist and professor of clinical medicine at Columbia.

According to Vitals.com, Dr. Reiffel completed his medical degree and residency at Columbia University.

Wellbutrin XL, the fourth-most prescribed antidepressant in the United States with 20.184 million prescription sold in 2007, is an example of an effective brand name drug whose generic equivalent disappointed many.

Joe and Teresa Graedon publish a popular syndicated column, The People’s Pharmacy, and are founders of a respected multimedia clearinghouse. In the summer of 2007 they had received so many complaints about the generic version of Wellbutrin XL, they decided to do an independent study collaborating with ConsumerLab.com. The results were astounding.

Among their many findings they discovered that although both products released the same amount of the active ingredient over 16 hours, the generic version released almost half of its medication after four hours and the brand name only one-quarter. This accounted for the side effects so many patients were experiencing, including irritability, headaches, insomnia and a depressed mood toward the end of the cycle.

Nowadays generics constitute almost 70 percent of all prescriptions dispensed nationwide and work well for many people. But with health insurers pressuring patients to use these drugs, patients and doctors need to be vigilant. When switching from a brand name to a generic, keep tabs on how they are affecting you. Report all your concerns to your doctor or to the FDA’s adverse events monitoring system, called MedWatch (www.fda.gov/medwatch).

2 Doctors Unlocking Mysteries Of Dystonia

Washington Post

In 1970, a Japanese pediatric neurologist named Masaya Segawa examined two girls. The girls were cousins and they seemed to be suffering from the same puzzling ailment: a contraction of the muscles that caused their limbs to twist uncontrollably, a condition known as dystonia. Six years later, Segawa encountered a 51-year-old woman who had been experiencing the same symptoms since the age of 8.

Segawa discovered that in all three cases the symptoms could be controlled by small doses of L-dopa, which the body converts into the neurotransmitter dopamine. The disorder goes by the name dopa-responsive dystonia but it's also known as Segawa's disease, after that observant Japanese doctor, one of the grand old men of pediatric neurology. It affects girls three to four times more frequently than boys. In 1993, researchers were able to find the gene that causes the abnormality, mapping it to chromosome 14q.

In 2003, Morgan Campagna was an 8-year-old girl living in Guantanamo Bay, Cuba, with her mother, Christie, and sister, Ashlyn. From the age of 4, Morgan had been experiencing strange symptoms, including a limp that worsened as the day progressed. Odder still, Morgan would draw her arms up to her chest, her hands twisting in on themselves.

"Doctors would tell me she was going to grow out of it, but nobody would tell me what 'it' was," her mother said.

A Navy doctor visiting the base decided this was not something Morgan was going to grow out of. The doctor arranged for Morgan to be seen by Mark Batshaw at Children's National Medical Center in Washington and his colleague Bennett Lavenstein.

"Dr. Batshaw invited me to see her and asked what I thought of her gait," said Lavenstein, a pediatric neurologist. "We put our heads together and, quite frankly, I thought L-dopa."

Dopamine has a lot of roles in the nervous system. With Segawa's disease, Lavenstein said, "we're focusing on predominantly dopamine in the basal ganglia of the brain, which is inherently responsible for controlling smooth, graded motions, as opposed to concentrations elsewhere, which may relate to attention deficit disorder, schizophrenia or the pleasure centers."

Because of an enzymatic deficiency, Segawa's patients are unable to synthesize dopamine properly, unable to control some of their muscles. The disease is similar to Parkinson's disease, without that ailment's inevitable downward spiral.

Morgan underwent a battery of tests -- liver function, amino acids, copper metabolism -- but her doctors at Children's were pretty sure they knew the answer. The correct diagnosis would be confirmed by the treatment. They started Morgan on a twice-a-day regimen of Sinemet, a pill used to treat Parkinson's. Within a week, her symptoms were almost gone.

Morgan is 16 now. Her family lives in Manassas. She likes science, likes to read, likes to draw her own comic books. She goes on walks without tiring easily, as she once did. She marvels at the fact she was once unable to control her body, remembering how strange it was to look down and find her hands up near her chin when she'd never intended to move them there.

"When I was little, I just thought I was normal," Morgan told me recently. "I didn't really know what normal was."

When Joints Take A Turn For The Worse

The Times Of India

Joint pain is often associated with old age. However, now, the young are also suffering from this as inactive lifestyles take hold. If the pains are resulting from arthritis, winter can prove to be a testing time for the sufferer, because low temperature causes the condition to worsen, said doctors.

They added that earlier, the season caused an increase in the number of old people complaining of joint pains, but now, the young were also being affected by the condition as they did not exercise much and tended to avoid other physical activity.

They stated that the young adult category had seen an increase in patient numbers by 20%.

“Generally, more women are prone to joint pains especially emerging from osteo-arthritis. The second major cause for this in women’s case tends to be rheumatoid arthritis. As the age of people contacting this condition is falling, it is leading to a lot of concern. Cold weather also causes more people to be affected. It also slows down the healing process for surgical stitches,” said Dr Harpreet Singh Gill, senior consultant and head of orthopaedics department, Apollo hospital.

He added that earlier, the average age of patients receiving rheumatoid arthritis treatments tended to be 50 and now many of them were in their 30s, with women being the worst-affected group. He stated that the way prevent the condition was having a good diet and exercising properly. Dr Gill added that on an average, 20 young women came to the OPD daily with these problems, while the number used to be just two or three a few years back. “Squatting too much, having an inactive lifestyle or being deficient in vitamin D are the main causes and the major modes of treatment are physiotherapy, lifestyle modification and medication,” he added.

Associate professor at Dayanand Medical College and Hospital, Dr Sanjeev Mahajan, said that the young could easily avoid the condition with more physical activity, which they were quite capable of. “Early diagnosis and change in lifestyle are effective in arthritis pain management,” he added. He mentioned that arthritis-related swelling tended to get worse as weather got cold. Dr Jagdip Madan, orthopaedician at Guru Teg Bahadur Hospital, said that young women were getting arthritis and the reason for that could be genetic or having a generally negligent attitude towards joints. Dr Madan said that in his hospital, about 15 to 20 young women came for treatment daily, which was quite a lot as arthritis was a problem encountered mostly in sexagenarians.

Over 45 Million Americans Without Health Insurance

USA Today

In the first six months of this year, 45.4 million Americans of all ages — or 15.1% of the population — had no health insurance, according to new National Health Interview Survey statistics released Wednesday.

In addition, 58.4 million (19.4%) people of all ages had been uninsured for at least part of the year prior to the interview, and 31.9 million (10.6%) had been uninsured for more than a year at the time of interview, according to a report from the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics.

The findings are from data analyses of almost 32,700 respondents. NHIS data, collected since 1957, is widely used to monitor health trends.

Among the other results from January to June:

— The percentage of children under age 18 without insurance at the time of interview was 8.2%.

— Among adults up to 64 years old, 60.6% of those who were unemployed had been uninsured for at least part of the past year, and 21.8% of those who had jobs had gone without insurance. Also, 32.9% of unemployed adults and 13.3% of employed adults in this age group had been without insurance for more than one year.

— Among those under age 65 with private health insurance, 22.7% were enrolled in a high deductible health plan (HDHP), including 6.4% who were enrolled in a consumer-directed health plan (CDHP).

— Nearly 50% of those with a private plan obtained by means other than through an employer were in a HDHP, and about 20% of those with a private plan were in a family with a flexible spending account (FSA) for medical expenses.

--- Nearly 1.3 Million state residents lacked a Michigan health insurance provider

— At the time of interview, 12.3% of poor children and 11.6% of near-poor children didn't have insurance.

— The percentage of near-poor children who lacked insurance at the time of interview decreased from 15.6% in 2008 to 11.6% in the first six months of 2009.

— At the time of interview, 80.9% of poor children and 57.8% of near-poor children were covered by a public health plan.

— The increase in public coverage for near-poor children increased from 53.4% in 2008 to 57.8% in the first six months of 2009. This was not a significant increase, according to researchers.

— At the time of interview, 8.4% of poor children and 35.1% of near-poor children were covered by private health insurance. Between 2008 and the first six months of 2009, there was no significant change in private coverage for poor, near-poor and not-poor children.

— The percentage of near-poor adults younger than 65 who didn't have insurance at the time of interview increased from 2008 to the first half of 2009.

--- Many Seniors are still in need of Michigan medicare plans

— Lack of health insurance coverage was highest in the South and West.

Doctors Approve Of Electronic Records, But Privacy Still A Concern

USA Today

U.S. physicians support the use of electronic medical records, but widespread concerns exist about privacy problems, two new studies show.

One study of more than 1,000 family practice and specialist doctors in Massachusetts found that 86% believed electronic health information exchange (HIE) would improve patient quality of care, 70% thought it would reduce costs and 76% said it would save time.

However, 16% said they were "very concerned" about possible privacy breaches, especially children's doctors, while a further 55% were "somewhat concerned." The study also found that none of the doctors wanted to pay the suggested $150 monthly fee for HIE and about half said they weren't willing to pay any fee.

The second study, which included 56 psychiatrists, psychologists, nurses and therapists at an academic medical center, found that most believed electronic health records healthcare pacs records were clearer and more complete than paper records, but not necessarily more factual.

However, 63% said they were less willing to record highly confidential information in a patient's electronic health record than on a paper record. And 83% said if they were a patient, they wouldn't want their mental health records to be routinely accessed by other health-care providers.

"Designers of future task management software systems will need to enhance electronic file security and simultaneously maintain legitimate accessibility in order to preserve confidence in psychiatric and other [electronic health record] systems," the researchers concluded.

Both studies are published in the January issue of the Journal of the American Medical Informatics Association.

Study Questions Use Of Anthracyclines By Breast-Cancer Patients

Wall Street Journal

Researchers presented new findings Saturday at a breast-cancer symposium here suggesting that the risks associated with anthracyclines, a class of chemotherapy drugs widely used to treat the disease, outweighed their benefits in some patients.

The findings renewed a debate over whether anthracyclines, which have been around since the 1960s, should remain the standard of care in treating breast cancer, or whether newer drugs should be used more frequently instead.

Anthracyclines are effective but can damage the heart, particularly when used in combination with Roche Holding AG's Herceptin, a highly effective medication used to treat women with HER2-positive cancer.

The researchers, from the Breast Cancer International Research Group, evaluated the efficacy and safety of two separate regimens to treat breast cancer, one comprised of Herceptin and anthracyclines and another comprised of Herceptin and non-anthracycline drugs. The researchers compared the two treatment regimens to a control group receiving anthracyclines, but not Herceptin.

The 10-year study, which includes 3,222 women with Her2-positive breast cancer, is sponsored by French pharmaceutical company Sanofi-Aventis SA and supported by Genentech, a subsidiary of Roche. The data presented Saturday was collected at the study's halfway point.

The data showed that, after five years, women in both Herceptin groups were significantly more likely to remain alive than those in the control group, and there wasn't a statistically significant difference in overall survival between those who received anthracyclines and those who got non-anthracyclines, according to Dennis Slamon, one of the study investigators and director of the women's cancer research program at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles.

But, women receiving the combination of Herceptin and anthracyclines had significantly more heart damage, including cases of congestive heart failure, than those getting Herceptin and non-anthracyclines. They also had more cases of leukemia, a secondary consequence of the chemotherapy. "The damage we're doing to the heart is not transient," said Dr. Slamon.

The results are consistent with an earlier analysis of less comprehensive data in 2005, which provoked considerable debate in the field. One group of oncologists, including Dr. Slamon, believes that doctors should move away from using anthracyclines as a uniform treatment for all cases of breast cancer and instead use it only in subgroups of patients, such as those who express both the Her2 gene and another one called the Topo gene.

"I don't know why we keep pushing the anthracycline agenda," said Dr. Slamon, who called these latest results a "direct assault" on these drugs.

However, other experts disagree, saying the data aren't convincing enough to change the standard of care.

"What the data show is that there's certainly no superiority" of the non-anthracycline treatment, said Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. But because the two treatment groups aren't significantly different on efficacy, "I'm just not of the view that [non-anthracycline therapy] is the preferred regimen," said Dr. Winer. "We have to be cautious before adapting new standards."

Dr. Winer also pointed out that, even though there wasn't a statistically significant difference in survival between the two Herceptin groups, there were a greater number of deaths among the patients who got Herceptin and non-anthracyclines than among those who got Herceptin and anthracyclines. The difference was 214 deaths to 185.

Gary Lyman, a professor of medicine at Duke University's Comprehensive Cancer Center, said he didn't think the results would change much the use of anthracyclines. His patients want the best treatment for the cancer they are facing at the moment and are less concerned about the potential future safety concerns. "When I go back home, they are not going to want to compromise the most effective treatment for cancer" because of concerns over heart damage or leukemia, he said.

However, "patients should be warned; they should be informed about these issues," said Dr Lyman.