Friday, February 05, 2010

THE UNEMPLOYMENT SITUATION – JANUARY 2010

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The unemployment rate fell from 10.0 to 9.7 percent in January, and nonfarm payroll employment was essentially unchanged (-20,000), the U.S. Bureau of Labor Statistics reported today. Employment fell in construction and in transportation and warehousing, while temporary help services and retail trade added jobs.

Household Survey Data
  • In January, the number of unemployed persons decreased to 14.8 million, and the unemployment rate fell by 0.3 percentage point to 9.7 percent.
  • The number of long-term unemployed (those jobless for 27 weeks and over) continued to trend up in January, reaching 6.3 million. Since the start of the recession in December 2007, the number of longterm unemployed has risen by 5.0 million.
  • In January, the number of persons unemployed due to job loss decreased by 378,000 to 9.3 million. Nearly all of this decline occurred among permanent job losers.
  • In January, the civilian labor force participation rate was little changed at 64.7 percent. The employment-population ratio rose from 58.2 to 58.4 percent.
  • The number of persons who worked part time for economic reasons (sometimes referred to as involuntary part-time workers) fell from 9.2 to 8.3 million in January. These individuals were working part time because their hours had been cut back or because they were unable to find a full-time job.
  • About 2.5 million persons were marginally attached to the labor force in January, an increase of 409,000 from a year earlier. (The data are not seasonally adjusted.) These individuals were not in the labor force, wanted and were available for work, and had looked for a job sometime in the prior 12 months. They were not counted as unemployed because they had not searched for work in the 4 weeks preceding the survey.
  • Among the marginally attached, there were 1.1 million discouraged workers in January, up from 734,000 a year earlier. (The data are not seasonally adjusted.) Discouraged workers are persons not currently looking for work because they believe no jobs are available for them. The remaining 1.5 million people marginally attached to the labor force had not searched for work in the 4 weeks preceding the survey for reasons such as school attendance or family responsibilities.
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Original content Bob DeMarco, All American Investor


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Tuesday, February 02, 2010

Is Medivation's Dimebon a $1.5 Billion Blockbuster Drug ?

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Medivation (MDVN) is expected to release the results of its Phase 3 clinical trial of Dimebon in the not to distant future. Dimebon is designed for the treatment of Alzheimer's disease.....
By Bob DeMarco

Pfizer Medivation previously announced the Dimebon CONNECTION study results would be released during the first half of 2010.

There is great expectation not only in the Alzheimer's community but amongst investors.

Alzheimer's disease effects more than 5 million people in the United States, and more than 30 million worldwide. These numbers are expected to triple by 2050.

As I look across the Internet I am noticing that several reputable research analysis are forecasting annual sales of $1 to $1.5 billion if Dimebon is approved by the Food and Drug Administrtion (FDA). Current sales of drugs for Alzheimer's, including Pfizer's (PFE) Aricept, already exceed $5 billion.

Judging by the number of Google searches for Dimebon, and the number of searches coming to the Alzheimer's Reading Room via Google, I believe it is safe to say that Dimebon is on the minds of most of the Alzheimer's community. The number of searches for Dimebon exceeds the number of searches for all other experimental drugs currently in clinical trials and focused on Alzheimer's disease. The same would be true of the emails I receive on the Alzheimer's Reading Room.

Medivation's (MDVN) CONNECTION study is the center piece of its experimental studies with Dimebon. CONNECTION is a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer's disease. The key word here is: confirmatory.

Patients in the CONNECTION study are not taking any other Alzheimer's drug. Dimebon's effectiveness will be measured by both the ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) and CIBIC-plus (Clinician's Interview-Based Impression of Change) tests. These are commonly used measures of cognition, memory and overall clinical function used to assess Alzheimer's patients. Over time, the ADAS-cog and CIBIC-plus scores of an Alzheimer patient decline as the patient gradually loses memory, and loses the ability to do normal everyday functions.

The purpose of the CONNECTION study is to determine if Dimebon can improve a patient's cognitive and overall function for a period to time, or at least slow the progression of the Alzheimer's disease.

Here is a straightforward comparison. Aricept, the number one selling Alzheimer's drug, demonstrated a 3-point improvement in ADAS-cog over placebo in its six-month pivotal study.

In Medivation's pivotal phase two study, the ADAS-cog benefit for Dimebon over placebo was 5.9 points at 9 months and 6.9 points at one year. Dimebon demonstrated statistically significant improvements in memory, cognition behavior and overall function. Remarkable or too good to be true? The results were met with lots of skepticism in the scientific community.

We are now awaiting the results for six-month, confirmatory, pivotal Phase 3 trial of Dimebon.

It should be noted that the phase two Dimebon study results were published in the prestigious British medical journal The Lancet in July 2008. This gives the experimental findings additional credibility. This added scrutiny of Dimebon should get your attention.

One issue that I will be looking at closely is how the patients on the Placebo score on the tests. There is scientific evidence that patients stay out of nursing homes longer when participating in clinical trials of experimental drugs -- even when the experimental drugs don't work. There is also evidence that study participants benefit substantially from the frequent, high-quality medical attention they receive as part of a clinical trial. These findings can be an issue in the results of any clinical trial.

Pfizer Medivation has additional clinical trials with Dimebon going on right now. The drug is being in tested in combination with Aricept; and, is also being tested separately in combination with Namenda.

It is widely known that the Dimebon CONNECTION study is for Alzheimer's patients with mild-to-moderate Alzheimer's disease. I don't think it is widely know that Dimebon is now being tested in patients with moderate to severe Alzheimer's Disease. There is no exisitng drug that is designed to work across the entire spectrum of Alzheimer's -- mild-moderate-severe Alzheimer's disease.

If Medivation's Dimebon proves out on either front -- mild-moderate or moderate-severe this could turn into a blockbuster drug. Both fronts and the sky is the limit.

Caregivers with family members and spouses suffering from Alzheimer's disease are already impatiently waiting for the Dimebon clinical trial test results and the verdict from the FDA. If the drug gains approval, doctors will be inundated with telephone calls for appointments. The only negative I can see for the Alzheimer's community is that this drug is going to be EXPENSIVE.

My guess is that this drug, by itself, will send older citizens into or near the Medicare donut hole by my birthday each year --August 12th. Ouch.

To read additional information about the CONNECTION study and about ongoing Dimebon clinical trials -- go here.
FULL DISCLOSURE: This is not an offer to buy or sell any stock, bond, or commodity. The author is not a registered securities analyst or associated with any member firm. The contents of this article are purely informational. All information was obtained from readily available public sources of information. The author does not own Pfizer (PFE) or Medivation (MDVN) at the time this article is being published.

The mother of the author, Dorothy DeMarco, is currently enrolled in a phase three clinical trial for Dimebon -- A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease.

Popular articles on the Alzheimer's Reading Room

Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,200 articles with more than 9,000 links on the Internet. Bob resides in Delray Beach, FL.



Original content Bob DeMarco, the Alzheimer's Reading Room



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Sunday, January 17, 2010

Antipsychotics, Johnson and Johnson, Kickbacks to Nursing Homes, the Feds Step In

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UNITED STATES FILES SUIT AGAINST DRUG MANUFACTURER JOHNSON & JOHNSON (JNJ) FOR PAYING KICKBACKS TO NATION’S LARGEST NURSING HOME PHARMACY
By Bob DeMarco
...for paying millions of dollars in kickbacks to Omnicare, Inc. (“Omnicare”), the nation’s largest pharmacy that specializes in dispensing drugs to nursing home patients.

U.S. Attorney Carmen Ortiz said, “Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving. Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy.”
This lawsuit and story pertains to the enormous amount of antipsychotics that are being given to nursing home patients.

In this case, Risperdal, like many other psychotics, raises the risk of death in patients with psychosis that stems from dementia. Risperdal is not approved to treat this form of psychosis. Nevertheless, the drugs have been widely prescribed to nursing-home patients with dementia.

The Wall Street Journal broke this story back in 2007 -- Antipsychotic Drugs Abused as Chemical Restraints for Elderly. The article pointed out that "almost a third of patients in nursing homes were receiving powerful antipsychotic drugs". They were being given the drugs whether the patients were psychotic -- or not.

United States files suit against drug manufacturer Johnson and Johnson for paying Kickbacks to Nation's Largest Nursing Home Pharmacy

BOSTON, MA - United States Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Justice Department’s Civil Division, announced today that the Government has filed a civil False Claims Act complaint against drug manufacturer Johnson & Johnson (J&J), of New Brunswick, New Jersey, and two of its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Johnson & Johnson Health Care Systems, Inc., for paying millions of dollars in kickbacks to Omnicare, Inc. (“Omnicare”), the nation’s largest pharmacy that specializes in dispensing drugs to nursing home patients. In November 2009, the United States, numerous states, and Omnicare entered into a $98 million settlement agreement that, among other things, resolved Omnicare’s civil liability under the False Claims Act for taking kickbacks from J&J.

U.S. Attorney Carmen Ortiz said, “Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving. Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy.”

“We will pursue those who break the law to take advantage of the elderly and the poor,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.“ Kickbacks such as those alleged here distort the judgments of health care professionals and put profits ahead of sound medical treatment.”

In its complaint against J&J, the United States alleges that J&J paid kickbacks to Omnicare to induce Omnicare to purchase and to recommend J&J drugs, including the antipsychotic drug Risperdal, for use in nursing homes. According to the complaint, J&J understood that Omnicare’s pharmacists reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients. The Government further alleges that J&J knew that physicians accepted the Omnicare pharmacists’ recommendations more than 80 percent of the time, and that J&J viewed such pharmacists as an “extension of [J&J’s] sales force.”

The United States alleges that, in order to induce Omnicare and its pharmacists to recommend J&J drugs, J&J paid kickbacks to Omnicare in numerous ways. First, the complaint alleges that J&J entered into agreements with Omnicare pursuant to which Omnicare was entitled to increasing levels of rebates from J&J so long as Omnicare implemented specific “Active Intervention Programs” to drive prescribing of J&J drugs. Second, the complaint alleges that J&J paid Omnicare millions of dollars for “data,” much of which Omnicare never provided. According to the complaint, the true purpose of these payments was to induce Omnicare to recommend J&J drugs, and J&J used the disguise of a data purchase arrangement to evade its obligations to disclose the payments to the Government and to pay rebates to state Medicaid programs. Third, the complaint alleges that J&J made various other substantial kickback payments to Omnicare, calling the payments “grants” and “educational funding” even though their true purpose was to induce to Omnicare to recommend J&J drugs.

In response to J&J’s kickbacks, according to the complaint, Omnicare undertook various “intervention” programs for J&J drugs. For example, Omnicare engaged in a “Risperdal Initiative” whose purpose, as J&J understood it, was “to persuade physicians to write Risperdal in the areas of Behavioral Disturbances associated with Dementia.” After the conduct at issue, the United States Food and Drug Administration mandated that the label for Risperdal carry a“black box” warning that “Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs [including Risperdal] are at an increased risk of death compared to placebo.” The United States filed its complaint in two consolidated whistleblower lawsuits presently on file in the District of Massachusetts.

This case was investigated by the Chicago, St. Louis, and Boston units of the Office of Inspector General of the Department of Health and Human Services, the Chicago unit of the Food and Drug Administration Office of Criminal Investigations and the Federal Bureau of Investigation. The case is being handled by Gregg Shapiro and Christine Wichers in Ortiz’s Civil Division and Laurie Oberembt in the Justice Department’s Civil Division.

CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV



Original content Bob DeMarco, the Alzheimer's Reading Room

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Thursday, January 07, 2010

Does Exposure to Cell Phones Reverse Alzheimer's Disease ?

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Microwave radiation from cell phones may protect against and even reverse Alzheimer's-like symptoms, according to a new study involving genetically tweaked mice......
By Bob DeMarco


I know this will sound hard to believe but the study found that if cell phone exposure began before genetically engineered mice started showing signs of Alzheimer's, they were less likely to develop symptoms later on in life.

Additionally, the genetically engineered mice that were were exposed to the cell phone radiation after they had already begun to show cognitive deficits generally saw their memory impairment disappear after several months of the radiation exposure.

Go figure.

The millions of people who spend hours every day on a cell phone may have a new excuse for yakking. A surprising new study in mice provides the first evidence that long-term exposure to electromagnetic waves associated with cell phone use may actually protect against, and even reverse, Alzheimer's disease. The study, led by University of South Florida researchers at the Florida Alzheimer's Disease Research Center (ADRC), was published today in the Journal of Alzheimer's Disease.
To continue reading go here.

Popular articles on the Alzheimer's Reading Room


Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,050 articles with more than 8,000 links on the Internet. Bob resides in Delray Beach, FL.


The Alzheimer's Action Plan: The Experts' Guide to the Best Diagnosis and Treatment for Memory Problems


Original content Bob DeMarco, Alzheimer's Reading Room



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Thursday, December 24, 2009

Dominick the Christmas Donkey

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Friday, December 04, 2009

THE EMPLOYMENT SITUATION -- NOVEMBER 2009

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The unemployment rate edged down to 10.0 percent in November, and nonfarm payroll employment was essentially unchanged (-11,000), the U.S. Bureau of Labor Statistics reported today. In the prior 3 months, payroll job losses had averaged 135,000 a month.

In November, employment fell in construction, manufacturing, and information, while temporary help services and health care added jobs.

The change in total nonfarm payroll employment for September was revised from -219,000 to -139,000, and the change for October was revised from -190,000 to -111,000.

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Household Survey Data

In November, both the number of unemployed persons, at 15.4 million, and the unemployment rate, at 10.0 percent, edged down. At the start of the recession in December 2007, the number of unemployed persons was 7.5 million, and the jobless rate was 4.9 percent. (See table A-1.)

Among the major worker groups, unemployment rates for adult men (10.5 per-cent), adult women (7.9 percent), teenagers (26.7 percent), whites (9.3 per-cent), blacks (15.6 percent), and Hispanics (12.7 percent) showed little change in November. The unemployment rate for Asians was 7.3 percent, not seasonally adjusted. (See tables A-1, A-2, and A-3.)

Among the unemployed, the number of job losers and persons who completed temporary jobs fell by 463,000 in November. The number of long-term unemployed (those jobless for 27 weeks and over) rose by 293,000 to 5.9 million. The percentage of unemployed persons jobless for 27 weeks or more increased by 2.7 percentage points to 38.3 percent. (See tables A-8 and A-9.)

The civilian labor force participation rate was little changed in November at 65.0 percent. The employment-population ratio was unchanged at 58.5 percent.(See table A-1.)

The number of people working part time for economic reasons (sometimes referred to as involuntary part-time workers) was little changed in November at 9.2 million. These individuals were working part time because their hours had been cut back or because they were unable to find a full-time job. (See table A-5.)

About 2.3 million persons were marginally attached to the labor force in November, an increase of 376,000 from a year earlier. (The data are not seasonally adjusted.) These individuals were not in the labor force, wanted and were available for work, and had looked for a job sometime in the prior 12 months. They were not counted as unemployed because they had not searched for work in the 4 weeks preceding the survey. (See table A-13.)

Among the marginally attached, there were 861,000 discouraged workers in November, up from 608,000 a year earlier. (The data are not seasonally adjusted.) Discouraged workers are persons not currently looking for work because they believe no jobs are available for them. The remaining 1.5 million persons marginally attached to the labor force had not searched for work in the 4 weeks preceding the survey for reasons such as school attendance or family responsibilities.

Establishment Survey Data

Total nonfarm payroll employment was essentially unchanged in November (-11,000). Job losses in the construction, manufacturing, and information industries were offset by job gains in temporary help services and health care. Since the recession began, payroll employment has decreased by 7.2 million. (See table B-1.)

Construction employment declined by 27,000 over the month. Job losses had averaged 117,000 per month during the 6 months ending in April and 63,000 per month from May through October. In November, construction job losses were concentrated among nonresidential specialty trade
contractors (-29,000).

Manufacturing employment fell by 41,000 in November. The average monthly decline for the past 5 months (-46,000) was much lower than the average monthly job loss for the first half of this year (-171,000). About 2.1 million manufacturing jobs have been lost since December 2007; the majority of this decline has occurred in durable goods manufacturing (-1.6 million).

Employment in the information industry fell by 17,000 in November. About half of the job loss occurred in its telecommunications component (-9,000).

There was little change in wholesale and retail trade employment in November. Within retail trade, department stores added 8,000 jobs over the month.

The number of jobs in transportation and warehousing, financial activities, and leisure and hospitality showed little change over the month.

Employment in professional and business services rose by 86,000 in November. Temporary help services accounted for the majority of the increase, adding 52,000 jobs. Since July, temporary help services employment has risen by 117,000.

Health care employment continued to rise in November (21,000), with not able gains in home health care services (7,000) and hospitals (7,000). The health care industry has added 613,000 jobs since the recession began in December 2007.

In November, the average workweek for production and nonsupervisory workers on private nonfarm payrolls rose by 0.2 hour to 33.2 hours. The manufacturing workweek increased by 0.3 hour to 40.4 hours. Factory overtime rose by 0.1 hour to 3.4 hours. Since May, the manufacturing workweek has increased by 1.0 hour. (See table B-2.)

In November, average hourly earnings of production and nonsupervisory workers on private nonfarm payrolls edged up by 1 cent, or 0.1 percent, to $18.74. Over the past 12 months, average hourly earnings have risen by 2.2 percent, while average weekly earnings have risen by 1.6 percent. (See table B-3.)

The change in total nonfarm payroll employment for September was revised from -219,000 to -139,000, and the change for October was revised from -190,000 to -111,000.

_____________
The Employment Situation for December is scheduled to be released on Friday, January 8, 2010, at 8:30 a.m. (EST).


Bob DeMarco is a citizen journalist and twenty year Wall Street veteran. Bob has written more than 950 articles with more than 8,000 links to his work on the Internet. Content from All American Investor has been syndicated on Reuters, the Wall Street Journal, Fox News, Pluck, Blog Critics, and a growing list of newspaper websites. Bob is actively seeking syndication and writing assignments.



Original content Bob DeMarco, All American Investor

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