Illinois Supreme Court Finds Caps on Damages To Be Unconstitutional

Much to the delight of all victims of medical malpractice and consumers in Illinois in general, the Supreme Court found that caps on non-economic damages as legislated by Illinois lawmakers was an unconstitutional interference of the legislative branch with the judicial branch of the government. This is a great victory for all victims of medical malpractice in Illinois. regrettably, the fight does not stop here and will now be focused, at least for us, to the Federal arena where Tort Reform is still a threat to all consumers and victims of malpractice.

Illinois Supreme Court to rule on medical malpractice cap

The Illinois Supreme Court struck down the state’s medical malpractice law today, saying it violates separation of powers by allowing lawmakers to interfere with a judge’s ability to reduce verdicts.

The much-anticipated ruling, which challenged the constitutionality of damage caps for doctors and hospitals, is being watched closely by the health care industry and employers that see caps on damages as a way to tame rising health care costs.

The ruling could figure in the national health care debate of stalled health care legislation. In the U.S. Senate where Republicans have opposed existing health care reform legislation, the GOP has been vocal about the need for tort reform and caps on damages.

Tort Reform Gives Bad Doctors a License To Kill.

License to kill | kill, license

Tort law defines what a legal injury is and establishes liability. All tort reform limits the circumstances under which injured people may sue and limits how much a jury may award the injured.

Is tort reform good or bad? That depends on who benefits and who loses out. It benefits the insurance companies in a big way. It benefits for-profit hospitals and clinics. It hasn’t reduced our medical bills.

The big loser is the patient who is injured or killed by bad medical practice. Tort reform makes Florida’s health care system less safe and effective. It limits victims’ access to the courts and costs taxpayers money in order to care for injured victims. If you’re injured by bad medical practice, you will have a near-impossible time finding a lawyer who will represent you because of the 2004 Florida tort reform. It effectively gives bad doctors a license to kill.

You Save Lives… AIG Limits your Healthcare!!

Isn’t this precious? These people are in a airplane crash–the plane crash landed in the Hudson River–and AIG is playing hardball in paying their claims. Insurance companies have generally adopted the triple “D’ approach to claims: Deny, Delay and Defend. Do not be intimidated by this tactic–it quickly falls apart when legitimate claims are brought before juries.

Nice job, Capt. Sullenberger. Now quit whining about that neck pain and get back to work!

In yet another P.R. coup for everyone’s favorite bailed-out insurance company, AIG balks at paying claims to passengers from the US Airways flight that miraculously landed in New York’s Hudson River last January. According to The New York Times, the firm tells passengers with medical bills to file claims with their own health insurers — assuming they have health insurance — and limits the number of therapy sessions for passengers traumatized by their brush with death to three.

Drink Up Johnny!

Alcohol Cuts CHD Risk in Men

Consumption of alcohol in almost any quantity is associated with a nearly one-third reduction in the incidence of coronary heart disease (CHD) — at least in men, a large Spanish study confirmed.

Reporting online in Heart, Larraitz Arriola, PhD, of the public health department in San Sebastian and colleagues wrote that a multivariate analysis determined the following reductions of CHD risk at these consumption levels:

* Low levels of alcohol (0 to 5 mg/day), HR 0.65 (95% CI 0.41 to 1.04)
* Moderate levels (5 to 30 g/day), HR 0.49 (95% CI 0.32 to 0.75)
* High levels (30 to 90 g/day), HR 0.46 (95% CI 0.30 to 0.71)
* Very high levels (more than 90 g/day), HR 0.50 (95% CI 0.29 to 0.85)

No significant associations were seen for women, however.

Many studies have examined the association between alcohol use and CHD. Most have suggested that moderate intake reduces the risk, with effects on high-density lipoprotein cholesterol, clotting factors, insulin sensitivity, and inflammation providing biologic plausibility for the observation.

However, scientists still debate whether the the association is truly causal, and whether the studies have been marred by “abstainer error.”

Abstainer error refers to classification of participants who had recently stopped drinking — usually because of declining health, frailty, or disability — as nondrinkers.

Insurance Is The Key–Not Income!

Uninsured Trauma Victims More Likely to Die

Even after adjusting for injury severity and comorbidities, trauma patients who did not have insurance had higher mortality rates than those who did, researchers said.

Lack of insurance increased the risk of death following traumatic injury by up to 89%, relative to individuals with commercial insurance, for various subgroups chosen to control for comorbidities, reported Heather Rosen, MD, MPH, of Children’s Hospital Boston, and colleagues.

These differences were seen in patients 18 to 30 years old, who would be expected to have few comorbidities; those whose records indicated that they had at least one comorbidity; and victims of head injuries, the researchers said in the November issue of Archives of Surgery.

The findings were not a function of income, according to their report: trauma victims with Medicaid coverage fared no worse, and in some cases better, than those with commercial insurance.

Really–Malpractice Claims Are Not An Issue! Really.

Malpractice: Savings Reconsidered

In 2004 we accused President Bush of using “dubious statistics” to support his claim that limiting malpractice awards to injured patients could save the economy between $60 billion and $108 billion per year. Ever since, we’ve said most independent research indicated little if any savings from limiting malpractice liability, and just a few weeks ago we quoted the Congressional Budget Office as saying that only negligible savings could be expected.

Now CBO has revised its opinion, based on new evidence. Citing recent studies, including two new economic papers published only last month, CBO concludes that limiting malpractice liability would reduce total national health care spending by about one-half of 1 percent, or about $11 billion this year. That would save taxpayers about $41 billion over the next decade in lower Medicare, Medicaid and other federal spending for health care.

That’s still not close to what Bush claimed five years ago, and what some Republicans are still claiming. But it’s a significant point in favor of a health care proposal that is generally opposed by Democrats.

An Interesting Read

Still Waiting for Health Care by Ralph Nader « Dandelion Salad

The victims of medical malpractice – estimated by the Institute of Medicine and the Harvard School of Public Health to be about 100,000 deaths a year – escaped having to overcome more hurdles before they have their full day in court. Helping to beat back the Republicans, who define “medical malpractice reform” as letting the negligent perpetrators get away with their lethal consequences, was Congressman Bruce Braley (D-IA).

Rising on the House floor he delivered a factual plea for patient safety. Hardly had he started to speak with Republicans started shouting “trial lawyer, trial lawyer” referring to his previous profession of representing wrongfully injured people before local juries in Iowa. This rare display of shouting by opponents was punctuated by one of their unleashed members rushing down the aisle shouting “You’ll pay for this.”

During this overall debate on the bill, Republicans stood up one by one, as prevaricatory dittoheads, to often scream and howl (like coyotes) that this is “a government takeover of one sixth of the economy,” “would destroy the economy,” “put 5.5 million people out of work,” “destroy the doctor-patient relationship,” “be a steamroller of socialism,” “force millions of seniors to lose their current health coverage” (meaning, Medicare?) and, in a passionate appeal to the Almighty, Congressman John Fleming (R-LA) declared “God help us as the government takes over your day-to-day life.”

Never mind that this bill is just an expansion, however misdirected, of government health insurance designed to increase corporate profits and increase the corporate grip over the day-to-day decisions regarding who, when and how people get their health care or get their bills paid.

To top off the madness, Senator Joe Lieberman (I-CT), an ever maturing political hermaphrodite, reneged on his assurance to Senate Majority Leader Harry Reid and imperiously announced on Fox News Sunday that “if the public option plan is in there, as a matter of conscience, I will not allow this bill to come to a final vote.”

For media-centric Joe, his motto seems to be “L’Senat c’est moi.”

The Young and the Old – Different Risk with H1N1 Virus

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.

Public Option is Still Alive… So It Seems.

Senator Says Public Plan Is In, SGR Gets Attention

When the healthcare reform bill comes up for a vote in the Senate, it will contain a public plan, the chairman of the Health, Education, Labor and Pensions (HELP) Committee said today.

“Yes, we’ll have a good strong, public option,” Sen. Tom Harkin (D-Iowa) told reporters Friday.

Harkin has been one of the main proponents of the public plan in the Senate, but Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, has said he doesn’t think the public option has enough votes to pass in the Senate.

H1N1 – Swine Flu Epidemic

Medical News: CDC Spells Out Process to Get Pandemic Vaccine to Patients

A minimum of 3.4 million doses of vaccine against H1N1 pandemic flu will be available in the first week of October, the CDC said.

Those doses — all in the form of a live attenuated nasal spray vaccine — may be supplemented by some injectable vaccine, according to Jay Butler, MD, the chief of the agency’s 2009 H1N1 vaccine task force.

“Additional vaccine may be available as well,” Dr. Butler told reporters, “but 3.4 (million) is the hard number that we have right now.”

After the first week of October, additional vaccine will become available, he said, eventually reaching 20 million doses delivered each week until the end of the year.

Butler cautioned that getting the vaccine to patients is likely to be logistically challenging, especially in the first days. “The flow of vaccine the first week or two may be slower than what we would like,” he said.

The U.S. has ordered 195 million doses of pandemic flu vaccine from five companies, and four of the vaccines have now been licensed by the FDA. (See FDA Approves H1N1 Vaccines)

To get them out, the government will use the same process employed by the Vaccine for Children program, which distributes medications to about 40,000 healthcare providers across the country, he said.

That network will be expanded by adding another 50,000 providers of various types.

But not all of those providers will have vaccine available for all patients immediately, he said. “There’s not a sudden appearance of vaccine in 90,000 refrigerators around the country,” Butler said.

The ordering process, he said, will begin with a request from a provider to the state health department, which will know from day to day how much vaccine is allocated to that state.

State allocations will be based on population.

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

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.

Come See My Show

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.

I Will Believe it When I See It.

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.

Free Drugs for A Year to Unemployed

Pfizer Offers Year of Free Meds to Unemployed

Drug giant Pfizer said unemployed people who have been taking its branded products could receive them free for up to a year in a new program — with some exceptions.

The program, called MAINTAIN, will provide access to more than 70 Pfizer drugs including atorvastatin (Lipitor), celecoxib (Celebrex), pregabalin (Lyrica), and sildenafil (Viagra).

But the program excludes biologics, most cancer drugs, and other of Pfizer’s most expensive products.

Individuals who became unemployed after Jan. 1 of this year are eligible for the program and may sign up through Dec. 31.

Other eligibility requirements include having taken the branded Pfizer drug for at least three months prior to losing a job, having no other prescription drug coverage, and being able to attest to financial hardship.

Income prior to becoming unemployed is not a factor, Pfizer said. But participants who regain employment or prescription drug coverage will have to start paying again.

A stock analyst quoted by the Associated Press pointed out that the program is likely to prevent some current Pfizer drug customers from switching to generic equivalents.

The company said it was taking signups today, although the program would not be fully operational until July 1.

Pfizer said signups and additional information on the MAINTAIN program would be available at Pfizer Helpful Answers or by calling 866-706-2400 toll-free.

Containing the Swine Flu

Europe Tries to Contain H1N1 Flu With Drugs

In an effort to contain the H1N1 (swine) flu outbreak, European countries are using antiviral drugs “very aggressively” to prevent transmission, a World Health Organization official said.

But WHO is cautioning that most cases of the disease appear to be mild ones that won’t need hospital care or antivirals, according to Nikki Shindo, M.D., who leads the agency’s clinical team that’s responding to the outbreak.

Dr. Shindo added that there’s no evidence yet of how well the medications — oseltamivir (Tamiflu) and zanamivir (Relenza) — work against the novel H1N1 strain.

In contrast, in the U.S. and Mexico — where the H1N1 outbreak can no longer be contained — officials are using antivirals mainly for treatment of people in high-risk groups or who have severe disease.

“The circumstance in the U.S. are very different from the circumstances in a number of European countries,” according to Anne Schuchat, M.D., of the CDC’s Science and Public Health Program.

“We don’t have a situation where we can contain the virus’s geographic distribution, and our focus is on reducing illness and death and mitigating the impact this virus has,” Dr. Schuchat said.

The priority for antiviral drugs is “where we think the treatment will make a difference,” she added.

Pandemic Vaccines May Not Arrive in Time!

Pandemic Vaccines May be Too Little, Too Late

If the swine flu outbreak develops into a pandemic — and that’s a big if — the earliest the public would see a vaccine against the disease would be September, a researcher said here at the conference on Influenza Vaccines for the World.

And that’s if the government asks industry to start production today, said Klaus Stohr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics and former head of the World Health Organization’s global influenza program.

“What we have seen the last two or three days is that the current pandemic vaccine system is not ideal not only in terms of timing . . . but also in terms of vaccine production,” he said.

A Lot to Consider in Healthcare Reform

Few Hospitals Meet Mortality-Reducing Quality Goals

Most hospitals in the 2008 Leapfrog Group quality survey did not meet standards shown to reduce mortality, researchers said.

Of the 1,282 hospitals taking part in the voluntary survey, which represents 48% of urban medical centers, many are falling short of mortality-reduction measures and are not delivering care efficiently, the nonprofit’s annual report said.

“As the Obama administration and Congress consider healthcare reform options, it is clear we have a long way to go to achieve hospital quality and cost-effectiveness worthy of the nation’s $2.3 trillion annual investment,” said Leapfrog CEO Leah Binder.

The new survey comes just weeks after the Journal of the American Medical Association published a study showing that adherence to National Quality Forum safety standards — including hand washing and having a competent nursing staff — do not result in lower mortality rates. (See: Hospital Mortality Not Linked to Safe Practices Score )

But the new survey focuses on factors that are known to reduce mortality, such as physician staffing levels in intensive care units and meeting prescription order-entry standards, said Binder.

Hospitals are not doing a good job of following recognized protocols for high-risk procedures, procedures that can reduce the risk of death significantly, said Barbara Rudolph, Ph.D., of the Leapfrog Group.

The State of Economy Doesn’t Help Either!

More Americans Report Frequent Mental Distress

State of mind may have a lot to do with state of residence — people who live in Hawaii have the lowest “frequency of mental distress” (6.6%), while Kentucky residents have the highest (14.4%), according to the CDC.
Action Points

* Explain to interested patients that this report is an analysis of self-reported survey data, which need to be cautiously interpreted because the findings are subject to a number of limitations.

But overall, more Americans have been experiencing more bad days in recent years — 10.2% of adults reported frequent mental distress in the period from 2003-2006, up from 9% in 1993-2001, wrote Matthew M. Zack, M.D., M.P.H., of the division of adult and community health at the National Center for Chronic Disease Prevention and Health Promotion at the CDC in Atlanta, and colleagues.

Those findings, published online today by the American Journal of Preventive Medicine,emerged from an analysis of responses from 2.4 million adults collected by the ongoing, random-digit-dialed telephone surveys conducted by the Behavioral Risk Factor Surveillance System. The analysis was performed in 2007 and 2008.

Dr. Zack and colleagues used 14 mentally unhealthy days as the threshold to define frequent mental distress.

The final analysis included results from 3,112 counties representing all 50 states and Washington, D.C.

“For the 1993-2001 period, the smoothed [frequent mental distress] prevalence was less than 8% in 989 (31.8%) of the 3,112 counties analyzed and was ≥12.0% in 148 (4.8%) of counties,” they wrote.

By comparison, in 2003-2006, “the smoothed [frequent mental distress] prevalence was <8% in 494 counties (15.9%) and ≥12.0% in 502 (16.1%) of the counties.”

The researchers excluded counties in which there were fewer than 30 responses to this question: “Now thinking about your mental health, which includes stress, depression, and problems with emotions, for how many days during the previous 30 days was your mental health not good?”

Among the findings:

* During 1993-2001, 15 states had at least one county where the prevalence of frequent mental distress was ≥12.0% and by 2003-206 that number had doubled to 30 states.
* The prevalence of frequent mental distress tended to decrease in contiguous parts of the upper Midwest (Minnesota, Wisconsin, and Michigan), and to increase in the Four Corners area (Utah, Arizona, Colorado, and New Mexico), the Mississippi Valley (Missouri, Arkansas, Tennessee, Mississippi, and Alabama), and the central Appalachian region (Pennsylvania, Maryland, West Virginia, Ohio, Kentucky, and Virginia).
* Alabama and Kentucky were the only states that remained in the top five for frequent mental distress prevalence in both time periods — 9.8% and 12.7% for Alabama in 1993-2001 and 2003-2006 and 14.4% in both time periods for Kentucky.
* In addition to Hawaii, other states with low rates of mental distress were South Dakota, Iowa, Nebraska, and North Dakota.

The authors pointed out that the survey has a number of limitations, including the fact that “risk factors do not respect state boundaries.” Moreover, states that have large urban populations “tend to reflect the [frequent mental distress] prevalence in those areas due to their sheer numbers, potentially obscuring the detection of high or low [frequent mental distress] prevalence in less-populated areas of the state.”

Additionally, they said, because the Behavioral Risk Factor Surveillance System excludes homeless persons, people who reside in institutions, households without landlines, and those who are unable to complete the survey because of language problems, the survey might underrepresent people with frequent mental distress.

Moreover, the prevalence rates might reflect factors such as age, gender, race/ethnicity, employment status, occupation, educational background, natural disasters and a number of other factors that were not controlled for in the study.

Nonetheless, the authors concluded that because the data do indicate “potentially unmet health and social service needs, programs for public health, community mental health, and social services whose jurisdictions include areas with high [frequent mental distress] levels should collaborate to identify and eliminate the specific preventable sources of this distress.”

No financial disclosures were reported by the authors.

Primary source: American Journal of Preventive Medicine
Source reference:
Moriarty DG, et al “Geographic patterns of frequent mental distress U.S. adults, 1993-2001 and 2003-2006” Am J Prev Med 2009;

FDA Approval Does Not Provide Immunity

In one of the most important business cases in years, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the product and its labeling.

The 6-to-3 ruling went in favor of a Vermont musician, Diana Levine, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the Wyeth pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases.

Drug Approval Is Not a Shield From Lawsuits, Justices Rule

Recall of Peanut Butter Frozen Cookie Dough

MINNETONKA, Minnesota — January 30, 2009 – Best Brands Corp. today announced that it is expanding its voluntarily recall of peanut butter frozen cookie dough as a precaution because the dough contains peanut products manufactured by Peanut Corporation of America (PCA). PCA is the focus of an investigation by the U.S. Food and Drug Administration (FDA) concerning a recent Salmonella outbreak. In response to PCA’s recently expanded recall, Best Brands Corp. is expanding its peanut butter frozen cookie dough recall to include all product manufactured since January 1, 2007.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare cases, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s website at http://www.cdc.gov.

Best Brands Corp. Expands Voluntary Recall of Peanut Butter Frozen Cookie Dough

Search for Food Recalls

Which foods are dangerous?

This database contains all allergy-related food recalls by the U.S. Food and Drug Administration and the U.S. Department of Agriculture from Oct. 1, 1998 through Oct. 1, 2008 — about 2,800 total. Also included are New York state alerts publicized by the FDA.

A Step in the Right Direction

No More Goodies for Doctors

Last year, besides giving away nearly $16 billion in free drug samples to doctors, pharmaceutical companies spent more than $6 billion on “detailing” – an industry term for the sales activities of drug representatives including office visits to doctors, meal-time presentations and branded pens and other handouts, according to IMS Health, a health care information company.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” – which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

“We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers,” said Allan Coukell, the director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine. “Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good.”

About 40 drug makers, including Eli Lilly & Company, Johnson & Johnson and Pfizer, have signed on to the code. Representatives of several pharmaceutical makers said their companies intended to comply with the guidelines, but they declined to discuss past marketing programs involving branded gifts.

FDA Contradicts Itself

With the FDA having become a politicized entity, I am not sure I can trust any of its findings and especially when they contradict itself. So which is it: melamine and cyanuric acid in baby formula is OK or not OK?

FDA Discounts Danger From Melamine in U.S.-Made Infant Formula

Levels of melamine found in a sample of U.S.-made infant formula do not pose a safety risk, the FDA said.

The agency detected trace amounts of the toxic chemical in a single sample of Nestle Nutrition’s Good Start Supreme Infant Formula with Iron.

Melamine was found in concentrations of 137 and 140 parts per billion. In an updated risk assessment, the FDA said that concentrations less than 1,000 parts per billion do not raise safety concerns. Earlier the FDA had said no level of melamine was safe. (See: FDA Says No Safe Level of Melamine in Baby Formula)

Agency testing also found cyanuric acid — a chemical relative of melamine — at concentrations of 247, 245, and 249 parts per billion in a single sample of Mead Johnson’s Enfamil Lipil with Iron. Levels below 1,000 parts per billion are considered tolerable, according to the updated risk assessment.

The FDA is still awaiting results from 13 of the 87 samples tested.

Report Ties Children’s Use of Media to Their Health

Full Story Here

Dr. Emanuel, Mr. Steyer and others plan to brief Washington policy makers on the study on Tuesday. Joined by researchers at Yale University and California Pacific Medical Center, Dr. Emanuel’s team analyzed almost 1,800 studies conducted since 1980 and identified 173 that met the criteria the researchers set.

In a clear majority of those studies more time with television, films, video games, magazines, music and the Internet was linked to rises in childhood obesity, tobacco use and sexual behavior. A majority also showed strong correlations — what the researchers deemed “statistically significant associations” — with drug and alcohol use and low academic achievement.

The evidence was somewhat less indicative of a relationship between media exposure and attention-deficit hyperactivity disorder, the seventh health outcome that was studied.

Dr. Emanuel, whose brother, Rahm, is the president-elect’s chief of staff, said he was surprised by how lopsided the findings were. “We found very few studies that had any positive association” for children’s health, he said.

Bush Legacy Could Be Found In Tort Reform

Surprise! Unapproved Product is Unsafe.

One thing I have a difficult time in apprehending is how is it that unapproved drugs and solutions can find their way into the market place so easily? Isn’t the purpose of the Food & Drug Administration to oversee and make sure that food and drugs sold in the market are safe before they are found to be unsafe? It does not take much to know a product is unsafe when people have been hurt… Unless people are used in the testing of a product placed into the market place all with the FDA’s blessing.

All this just does not make sense to me.

Unapproved Eye Solution, Papain Drugs Cited by U.S.

The U.S. told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with both products.The Food and Drug Administration warned it may act against companies that continue to sell ophthalmic balanced salt solution for the eyes and topical drugs containing papain, drawn from papayas, without regulatory approval, the agency said today in a statement.

After years of devoting few resources to unapproved drugs, FDA officials in 2006 said they would begin to crack down on the medicines. The agency has estimated they account for about 2 percent of prescriptions.

Companies selling unapproved versions of the eye drug and lesion treatment “have bypassed the requirement of the law and put consumers at risk,” said Deborah M. Autor, director of the FDA’s drug compliance office, on a conference call with reporters.

Unapproved versions of the eye drugs have been sold by Deerfield, Illinois-based Baxter International Inc., Lake Forest, Illinois-based Hospira Inc. and B. Braun Medical Inc., part of B. Braun Melsungen AG, a closely held company based in Melsungen, Germany, according to the FDA.

Everyone Wants Heatlhcare Reform

Americans Opt by Landslide for Wholesale Revision of Healthcare System

“A majority of adults look to the next president to lead by proposing reforms that could improve the quality of healthcare, ensure affordable care, and decrease the number of uninsured,” the survey report said. “Across income levels, region, and political affiliation, adults want presidential candi­dates to focus on health reforms in each of these areas.

“About nine of 10 adults say it is important for presidential candidates to have reform proposals that would improve the quality of care (90%), ensure care and insurance are affordable (93%), and decrease the number of uninsured (88%). In fact, a majority think these policy priorities are very important.”

Irrespective of income, 32% of the respondents called for a completely rebuilt health system and another 50% percent thought it required fundamental changes.

Eighty-one percent of respondents who were insured all year and 89% who were uninsured at some point during the year called for fundamental change or complete rebuilding.

About nine out of 10 respondents think the next president should take steps to improve healthcare quality, reduce the cost of healthcare and decrease the number of uninsured people.

The majority of respondents (73%) expressed frustration with their recent healthcare encounters including difficulty getting regular doctor’s appointments, receiving advice and seeing a clinician during non-office hours.

If Only the FDA Would Do Its Job!

Lawmakers to Consider Unbiased System to Compete with Drug Marketers

WASHINGTON, Aug. 1 — Congress is kicking around the idea of funding ostensible truth squads to disseminate unbiased reports on prescription drugs in an effort to counter claims made by drug company representatives.

A bill, introduced in both congressional chambers yesterday, would set up a grant program to send healthcare professionals to physicians’ offices armed with independent data about the relative risks, benefits, and costs of the drugs.

The bill stipulates that the healthcare field representatives — most likely nurses or pharmacists — would be barred from receiving money from any drug company.

“This bill will provide an important alternative to the way doctors currently get their information about drugs — from the drug companies themselves,” said Herb Kohl (D-Wis.), the sponsor of the Senate bill. “By providing physicians with thorough, independent research on all the drugs available to them, we believe we can improve the quality of healthcare and reduce the cost of prescription drugs in America.”

The bill would provide grants to academic medical centers, government entities, nonprofits, or research institutes to create educational materials on prescription and non-prescription drug information safety, effectiveness and costs, compared with other alternatives.

The bill would provide 10 grants for a public entity, a nonprofit, a private company, or an academic institution to develop a curriculum and to train those with appropriate clinical backgrounds to visit physicians’ offices to discuss medications.

“For far too long, most of the information physicians receive to make prescribing decisions has come from the drug companies’ marketing reps, not independent experts,” said Henry Waxman (D-Calif.), the sponsor of the House version of the bill. “This important legislation will go a long way toward giving doctors another, less biased perspective.”

The bill is backed by the Prescription Project and the National Coalition for Appropriate Prescribing, which are calling the move toward a more education-based approach to prescribing “academic detailing.”

“We need a program like this to counter the pharmaceutical industry’s marketing free-for-all,” said Robert Restuccia, executive director of the Prescription Project. “Academic detailing programs already exist in other countries and in several states, and they’ve been shown to improve care and generate savings.”

The bill contains no projected price tag.

Bad Neighbors and Boxing Gloves

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.

Not Only Tomatoes

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.

Eat Fish… Or Not.

This article starts in a promising manner about how eating oily fish can reduce risk of rheumatoid arthritis (RA). But then in the last sentence of the article this appears: “In a separate analysis, consumption of fish oil supplements had no effect on the risk of rheumatoid arthritis.” So, where is the beef?

EULAR: Fish Rich in Omega-3 May Reduce RA Risk

Eating oily fish at least once a month may help fend off of rheumatoid arthritis, a large observational study has suggested.

People who reported eating one or more servings of oily fish each month had a 20% lower risk of rheumatoid arthritis compared with individuals who reported seldom or never eating oily fish, such as salmon, mackerel, and herring, Annmarie Wesley of the Karolinska Institute in Stockholm, reported here at the European League Against Rheumatism congress.

More Health Care Makes not Better… Necessarily.

This study shows that the intensity of care in hospitals is generally more in private providers as opposed to public ones. Yet, the result is pretty much the same.

In New York City, Two Versions of End-of-Life Care

The Dartmouth Atlas, from which the data is drawn, includes 46 New York City hospitals: 8 public and 38 private.

The Consumer Reports rankings allow consumers to look at data from hospitals across the country, and examine the intensity of care during the last two years of life. Intensity is measured by how many days the average patient spent in the hospital, how many times a doctor visited that patient and how much the patient or private insurer spent for doctors beyond what Medicare covered.

Patients in the city’s private hospitals averaged 54 visits from doctors, while those in public hospitals averaged 24 visits during the final six months. In private hospitals, 56 percent of patients saw 10 or more physicians, compared with 32 percent in public hospitals.

And private patients paid an average of $4,000 out-of-pocket over two years, nearly double the $2,200 per patient at the city-run institutions. But in terms of the ultimate outcome, there was little difference.

The Dartmouth Atlas showed that 58 percent of the public-hospital patients died in the hospital as opposed to at home or in hospice care, compared with 57 percent for private hospitals. Thirty percent of patients in public hospitals had been admitted to intensive care units before their death, compared with 27 percent in private hospitals.

Many fewer patients from public hospitals — 7 percent — were enrolled in a hospice than patients from private hospitals, where the rate was 12 percent, according to the Dartmouth data.

Call for Tighter Control on Drug Ads

I am puzzled as to why even have these? People second guessing their physician about what drug is best for them is the most logical outcome expected from these ads…

AMA Calls For Tighter Drug Ad Oversight

Critics have long pointed out that consumers are in no position to purchase prescription drugs without their doctor. The sole point of advertising to consumers, they claim, is to prompt consumers to specifically request a particular prescription drug.

At the hearing, the AMA discussed the need for FDA regulation over DTCA and shared guidelines for DTCA that address advertising content, disclosures, and audiences targeted.

“The AMA guidelines for DTCA can help ensure that patients receive information about prescription drugs that is accurate, educational, well-balanced and encourages patient-physician communication,” Nielsen said.

From Wall Street Journal’s Health Blog

Pfizer Starts Cutting Deals on Celebrex & Bextra Lawsuits

Pfizer has reached tentative settlements with lawyers representing hundreds of people who say the painkillers Celebrex and Bextra caused heart attacks and strokes, the WSJ is reporting this afternoon.

Unsafe Plastic Bottles Pulled from the Market

Wal-Mart, Nalgene Pull BPA Bottles from Shelves

Wal-Mart said it would phase out BPA from all the baby bottles it sells, replacing them with different plastics or glass.

“Safety is a top priority for Wal-Mart,” the company said in a statement. “While the FDA has not established any restrictions on the use of bisphenol A (BPA) in baby bottles, for several years now we have offered a variety of BPA-free products for customers who seek this option.

We are working to expand our BPA-free offerings and expect the entire assortment of baby bottles to be BPA-free sometime early next year.”