The Young and the Old – Different Risk with H1N1 Virus

November 12, 2009

Young People More Likely to Get H1N1 Flu, Study Reaffirms

A Mexican study has confirmed that younger people were more likely to become infected with the pandemic H1N1 influenza virus but that older people were more likely to die from it.

The majority of confirmed infections (56%) occurred in individuals 10 to 39 years old, with only 10.2% occurring in people 40 and older, according to Victor Borja-Aburto, PhD, of the Mexican Institute for Social Security in Mexico City, and colleagues.

“The high incidence of infection in young people could show not only their different exposure related to their daily activities but also that people older than 60 years might have some immunity against the H1N1 virus,” they wrote online in The Lancet.

However, the death rate was highest among those 70 and older, at 10.3%. The death rate was 2% or less for all age groups younger than 40.

The findings are consistent with previous epidemiological studies of the ongoing pandemic.

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Their Lawyer Says Corporate Integrity is Their No. 1 Goal.

September 3, 2009

Medical News: Pfizer Settles Fraud Charges for $2.3 Billion

Pfizer will pay the government $2.3 billion to settle criminal and civil charges that it promoted off-label uses for the disgraced painkiller valdecoxib (Bextra) and three other drugs.

The Justice Department said it was the largest healthcare fraud settlement in history.

More than half the settlement — $1.3 billion — involves Pfizer’s efforts to promote valdecoxib, a COX-2 inhibitor withdrawn from the market in 2005 because of cardiovascular and other risks.

Pfizer’s sales staff had urged doctors to prescribe the drug for surgical pain and to prevent deep vein thrombosis, according to court records from a criminal trial of a Pfizer manager earlier this year.

The other $1 billion covered charges that Pfizer improperly promoted the antipsychotic drug ziprasidone (Geodon), the antibiotic linezolid (Zyvox), and pregabalin (Lyrica), approved for epilepsy, fibromyalgia, and neuropathic pain.

The settlement will be shared between the federal government, state Medicaid programs, and whistleblowers. The latter include a Pennsylvania psychiatrist and at least one former Pfizer employee whose allegations helped launch the investigation.

Their complaints, which had been sealed until the settlement was reached, provided details on Pfizer’s alleged transgressions.

For example, according to one complaint, Pfizer pushed linezolid for several types of infections not named on its FDA-approved labeling, and also claimed it was superior to vancomycin without FDA approval.

Similarly, Pfizer was said to have promoted ziprasidone — approved only for schizophrenia or acute manic or mixed episodes associated with bipolar disorder — for depression, obsessive-compulsive disorder, autism, and a host of other conditions.

In addition to promoting the off-label uses, Pfizer was also accused of paying kickbacks to doctors who prescribed the drugs.

Sales of ziprasidone, pregabalin, and linezolid in 2008 totaled about $2.5 billion, according to the consulting firm SDI Health.

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Come See My Show

August 21, 2009

Evanston artist to show photos at ‘THREE’

August 20, 2009
SRO: PEOPLE TO WATCH

“THREE,” the third annual fall show by artists at Margin Gallery and Collective, co-founded by Nima Taradji of Evanston, will open Sept. 4 at 1915 S. Halsted St., Chicago. Taradji also co-founded Hello Artichoke, another cooperative gallery in Los Angeles, where he worked as a commercial photographer, shooting celebrities in art, music and modeling. He later took a break from commercial photography to attend law school in Chicago. Besides the photographs of Taradji and others, “THREE” will include paintings, drawings, ceramics and metalwork. An artists’ talk will be held at 7 p.m. Sept. 4 and an opening reception between 6-10 p.m. Sept. 11. Gallery hours are 5-9 p.m. Fridays, 12-7 p.m. Saturdays and 12-5 p.m. Sundays. Visit www.margingallery.org.

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I Will Believe it When I See It.

August 7, 2009

FDA Chief Promises Tougher Stance on Food and Drug Safety

FDA Commissioner Margaret Hamburg, MD, vowed that the agency would be more aggressive in enforcing food and drug safety regulations and quicker to act when a company breaks the law.

In a speech at the Food and Drug Law Institute, Hamburg said that some FDA enforcement actions over the past several years have been “hampered by unreasonable delays” and that there has been a “steep decline in enforcement.”

“In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding, false, misleading, or otherwise unlawful labeling, and misleading advertising.”

The new FDA — the one Hamburg took the helm of just eight weeks ago — will be much more aggressive and visible. “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” she said.

Specifically, she said, the agency will do the following:

* Create a clear timetable for companies to respond to FDA inspection findings, generally no more than 15 days after the inspection. If the company fails to respond, the agency will issue a warning letter or take other enforcement action.
* Streamline the warning letter process by limiting legal review of letters to those that might actually present major legal issues, and prioritize the follow-up process on warning letters.
* Rely more on local, state, and international officials in food safety situations that require quick action.
* Be prepared to act “swiftly and aggressively” when dealing with significant public health concerns, possibly even before a formal warning letter is issued. The agency will no longer issue multiple warning letters before dealing with a violation, Hamburg said.
* If a company has corrected whatever issues were raised in a warning letter, the FDA will publicly clear the company on its Web site. Hamburg called it a “close out process.”

By beefing up its enforcement efforts, Hamburg said the FDA will ensure that “violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”

Since Hamburg took the helm of the FDA, the agency has been aggressive in cracking down on the makers of misleading or potentially dangerous products.

For instance, the FDA recently issued 65 warning letters to Web sites hawking phony products that supposedly prevent, diagnose, or treat the H1N1 (swine flu) virus — including a “virus killing” shampoo. According to Hamburg, 80% of the Web sites contacted by the FDA have removed the products.

Where 10 such products were popping up every day, the FDA is now aware of about two new ones a week.

Also, the FDA last week sent warning letters to companies that sell dietary supplements containing anabolic steroids, and posted a public health advisory warning consumers to avoid body-building supplements that contain androgen, estrogen, and progestin-related ingredients.

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Bad Neighbors and Boxing Gloves

July 10, 2008

I was surprised to see that Allstate beat State Farm in this race for Worst Insurere Title. Now you can decide with whom you should insure yourself.

You’re Not In Good Hands When It’s Time To Pay – Worst Insurers Report

The American Association for Justice, an organization of personal injury attorneys, often has to go up against insurance companies. So they might be considered a good source for knowing which ones actually pay and which do not.

Drum roll please – The number one worst insurer for consumers is Allstate, says AAJ.

AAJ investigators sorted through thousands of legal documents, financial filings, as well as complaints filed with state insurance departments, the Securities and Exchange Commission, and FBI records, to determine how many claims were paid and how often the company employed hardball tactics against policyholders.

“While Allstate publicly touts its ‘good hands’ approach, it has instead privately instructed its agents to employ a ‘boxing gloves’ strategy against its policyholders,” said American Association for Justice CEO Jon Haber says in a statement. “Allstate ducks, bobs and weaves to avoid paying claims to increase its profits.”

Allstate is known to force consumers to accept lowball claims or to deny claims altogether. One Allstate employee reported that supervisors told agents to lie and blame fires on arson, and in turn, were rewarded with portable refridgerators.

Among other wrongdoings AAJ found were extravagant salaries for upper-ranked executives and raising premiums while hoarding profits.

Rounding out the rest of the Top Ten are:

* Unum – which sells disability insurance. In 2005, Unum agreed to a settlement with insurance commissioners from 48 states over their practices.

* AIG – The world’s biggest insurer, AIG’s slogan was “we know money,” and is accused of engaging in massive corporate fraud and claims abuses, paying $1.6 billion to settle a host of charges.

* State Farm – Lawyers are familiar with State Farm’s deny and delay tactics, especially during Hurricane Katrina.

* Conseco – Conseco sells long-term care policies, typically to the elderly, unfortunately a delay may mean that the insured either died or gave up. Company was fined for filing misleading financial statements with regulators.

* WellPoint – Health insurer with a long history of putting profits ahead of policyholders, canceling policies of pregnant women and chronically ill.

* Farmers – Swiss-owned ranks at or near the bottom of homeowner satisfaction surveys, partially based on its “Quest for Gold” policy that offered incentives to those agent with low claims payout goals.

* UnitedHealth – Following an SEC investigation, the former CEO had to return more than $600 million in compensation.

* Torchmark – According to Hoover’s In-Depth Company Records, Torchmark’s very origins were little more than a scam devised to prey on low-income Southerners and minority policyholders.

* Liberty Mutual – Like Allstate and State Farm, Liberty Mutual hired consulting giant McKinsey to adopt aggressive tactics.

While the insurance industry has relied on McKinsey Consultants to determine how best to attain and retain profitability, over the last decade the industry has enjoyed annual profits exceeding $30 billion while taking in more than $1 trillion in premiums annually.

CEOs took home an average of $8.9 million in 2007, while median company CEOs can earn $1.6 million per year.

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Not Only Tomatoes

July 2, 2008

Whole Salad Bowl Now Target of Expanded FDA and CDC Investigation

The FDA and CDC have expanded their investigation of the ongoing Salmonella Saintpaul outbreak to target “foods commonly served with tomatoes.”

But David Acheson, M.D., the FDA’s food safety director, refused to name the other possible salad-bowl suspects, although he did confirm that evidence uncovered over the weekend persuaded the FDA and CDC to widen the search.

Nonetheless, Dr. Acheson said, tomatoes remain the main suspect.

In addition to widening the search to include other produce, Dr. Acheson said the FDA has activated the Food Emergency Response Network (FERN), a cooperative laboratory network established in the wake of Sept. 11.

He said that FERN was last activated during the E. coli contaminated spinach investigation last year and before that was used to pinpoint the source of contamination of dog food imported from China.

Also today the CDC announced that the number of confirmed Salmonella serotype Saintpaul cases now stands at 869, with 107 hospitalizations.

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Increase in Personal Injury from Baby Products

March 1, 2008

According to the Wall Street Journal, personal injury resulting in nursery products were up 11% in 2006, accounting for 66,400 personal injuries.

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How Accurate is a Mammogram?

December 13, 2007

Accuracy of Diagnostic Mammogram Interpretation Varies by Work Setting

Radiologists at academic medical centers are more likely to interpret diagnostic mammograms accurately than those at non-academic centers, according to researchers here.

So found a review
of 123 radiologists who interpreted 35,895 diagnostic mammography
examinations at 72 facilities that contribute data to the Breast Cancer
Surveillance Consortium, Diana L. Miglioretti, Ph.D., of Group Health
Cooperative, and colleagues reported online in the Journal of the National Cancer Institute.

After
controlling for patient characteristics, radiologists working in
academic medical centers achieved a median sensitivity of 88% (95% CI:
77% to 94%) versus a median sensitivity rating of 76% (95% CI: 72% to
79%) for non-academic radiologists.

So found a review
of 123 radiologists who interpreted 35,895 diagnostic mammography
examinations at 72 facilities that contribute data to the Breast Cancer
Surveillance Consortium, Diana L. Miglioretti, Ph.D., of Group Health
Cooperative, and colleagues reported online in the Journal of the National Cancer Institute.

After
controlling for patient characteristics, radiologists working in
academic medical centers achieved a median sensitivity of 88% (95% CI:
77% to 94%) versus a median sensitivity rating of 76% (95% CI: 72% to
79%) for non-academic radiologists.

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