Health Spectator

According to a story that appeared over the weekend from the Associated Press, the U.S. Solicitor General has been meeting with lawyers representing the tobacco industry’s four largest companies in an effort to forestall an appearance before the U.S. Supreme Court to follow up on a 2006 ruling by U.S. District Judge Gladys Kessler that the tobacco industry had concealed the dangers of cigarette smoking over a period of decades. The government has been considering asking the Court to award it $280 billion in past company profits and $14 billion toward a national campaign to limit smoking. Those awards had been denied by lower federal courts, one of which nevertheless denied an appeal by the defendants last May.

Since the lawsuit invovled charges of racketeering under the federal Racketeer Influenced and Corrupt Organizations Act (“RICO”), the losing defendants had vowed to pursue an appeal to reverse those charges. The conflicting goals are leading to an interesting stand-off. Both sides may stand to gain from negotiation. Although the companies undoubtedly would like to have the racketeering conviction dropped, there would seem to be little hope of that, giving the preponderance of the evidence.

Tobacco company defendants in the lawsuit are Philip Morris USA Inc. and its parent company, Altria Group Inc.; R.J. Reynolds Tobacco Co.; British American Tobacco Investments Ltd.; and Lorillard Tobacco Co. A former U.S. subsidiary of British American Tobacco, Brown & Williamson Tobacco Corp., merged with Reynolds in 2004.

Just three of those companies—Philip Morris, R.J. Reynolds and Lorillard—supply nearly 90 percent of U.S. retail cigarette sales.

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Johnson & Johnson announced yesterday that it was recalling Tylenol, Motrin, and St. Joseph’s aspirin as well as other over-the-counter drugs because they emit a moldy smell that has sickened some users. The Food and Drug Administration (FDA) has criticized the New Brunswick, NJ-based company and sent it a warning letter for not taking faster action, as the problem first occurred in early 2008 and recurred less than a month ago, but little has been done by the firm to address the issue.

The New Brunswick, NJ manufacturer has agreed to stop shipping products while it investigates the problem, which apparently has been traced to a chemical used to treat wooden shipping pallets. The Associated Press is reporting that the FDA traced the problem to a facility in Las Piedras, Puerto Rico.

Products affected include both regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin. Consumers can find out exactly which batches have been recalled by going to the McNeil website. (McNeil is the division of Johnson and Johnson responsible for these products.)

These problems come not long after an FDA advisory panel recommended removing acetaminophen-containing narcotic drugs from the market last summer because of the potential harm to the livers of patients caused by acetaminophen. Acetaminophen is the active ingredient in Tylenol. That same panel recommended lowering the largest dose of acetaminophen or Tylenol from 500 mg to 325 mg.

To date, no further action has been taken and Extra Strength Tylenol—available over the counter in any drugstore—still contains 500mg of acetaminophen.

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We first wrote about bisphenol-A (BPA) about two years ago. In that article, we noted that while parents were shying away from plastic baby bottles containing the substance, they were largely unaware that BPA was actually found in larger quantities in most liquid baby formulas because it leaches from the linings of the cans used to package them. Powdered infant formulas, because they needed to be diluted with water, were deemed likely to be a lower source of the substance, but by no means exempt from suspicion.

We recently came across the video below, which does a good job of explaining the dangers and sources of BPA. This substance is of concern not only for infant formulas, but for food packaging and preparation in general, since BPA is used in many plastics used to store and prepare food and beverages, as well as to line all cans sold in the U.S. Since BPA is a serious endocrine disruptor linked to both breast and prostate cancers and is found in the bodies of 93% of the U.S. population, this is bad news for Americans. Any soda you buy—because it will come stored either in a can or a plastic bottle—is likely to be contaminated with the substance. The same follows for virtually any packaged food or beverage, including, for example, canned vegetables. Yet, independent studies performed on BPA even in extremely low doses indicated that the chemical was disruptive to both male and female reproductive systems.

This video follows the history of BPA and shows how the EPA has spent millions of taxpayer dollars earmarked for screening chemicals such as BPA without apparently doing anything. It also interviews scientists concerned with this toxic pollutant.

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You may remember the case of Andrew Speaker. He went to Italy to be married and returned with a drug-resistant form of tuberculosis that caused a national furor and was reported on this website. The furor arose because Speaker traveled by plane with a highly contagious, hard-to-cure disease. At one point, Speaker was diagnosed by the CDC as having “extensively drug resistant tuberculosis.” That diagnosis was later downgraded to “multi-drug resistant tuberculosis.” Even so, Speaker was faced with a two-year regimen of drugs or surgery. He chose the surgery and recuperated, we are happy to report, without further complications.

While Speaker’s case became an instant sensation, the CDC and other public health officials managed to keep quiet a much more insidious form of the disease that appeared on our shores just a few months later, around September 2007. A 19-year-old student named Oswaldo Juarez came to the U.S. from Peru to study English. When he found himself coughing up blood, he knew something was very wrong.

He was diagnosed as having “extremely drug-resistant tuberculosis”—two cuts above the variety that Speaker had. After three months of futile treatment by a local hospital in Fort Lauderdale, he found himself living at the A.G. Holley State Hospital, the nation’s last tuberculosis sanitarium, located just south of West Palm Beach.

After approximately a two-year regimen not unlike chemotherapy for cancer, Juarez was pronounced cured and allowed to leave the facility. That was in July of this year. After 19 months of treatment at A.G. Holley, Juarez was now 21 and fluent in English.

The Associated Press reports that the Florida taxpayers paid about $500,000 for his treatment, which nonetheless was money well spent, since had he not been treated he most likely would have infected others and might have started an epidemic of virtually incurable tuberculosis had he continued to live in the U.S. or attempted to return home to Peru. According to AP reports, doctors had apparently told him he might only live about a month if he returned to Peru.

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The Taiwan News is reporting that a gynecologist identified only as Dr. Liu plans to sue the Centers for Disease Control in Taiwan over the death of his seven-year-old son in the wake of an H1N1 vaccination the child was given at school on November 19.

The case has been made public by Chang Yao-tsung, an opposition Democratic Progressive Party member of the Taichung City Council, speaking on behalf of the child’s parents.

The report says the child had no previous history of medical problems. Like many cases linked by parents to vaccinations, this one began with almost immediate symptoms. The child began suffering with red blotches on the soles of his feet the day following the vaccination. A private clinic diagnosed the condition as either an allergy or a reaction to the shot. Over the following two weeks, despite treatment with medications, the blotches spread over the child’s entire body. The frantic parents moved him from hospital to hospital, demanding ever more expensive treatments and tests. Some doctors said that the child’s immune system was not functioning properly. Despite all efforts, the child died yesterday, December 21. The official diagnosis was sepsis, commonly known as blood poisoning.

We cite the following directly from the Taiwan News:

A total of almost 4.8 million people had been vaccinated so far, according to CDC statistics.

Including the boy, a total of four deaths were recorded following inoculation, including men aged 82 and 50 respectively who had difficult health histories, and a high school student, reports said.

Five pregnant women were reported with problems ranging from miscarriage to a stillborn infant.

Of… 331 lighter cases, 43 percent were dizzy after being inoculated, 20 percent registered a fever, 18 percent felt ill, 17 percent had a headache and 11 percent vomited, according to CDC data.

The CDC denies that the boy’s sickness and death had anything to do with the H1N1 vaccination.

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If you’ve made it this far, chances are better you won’t be getting the swine flu. The fall wave has peaked, experts seem to agree, and while there will surely be more cases to come, they are on the wane. The Centers for Disease Control and Prevention (CDC) is warning that another (winter) wave may occur in January, possibly prompted by students returning home from college during the Christmas holidays, but thus far, the flu pandemic has been a relative non-event as flu pandemics go.

So far, pandemic H1N1 is still crowding out other influenzas, such as seasonal H1N1 and H3N2. Since September, the CDC has tested 420 patient samples that were positive for influenza, and of those, only eight were not pandemic H1N1. Indeed, only one was seasonal H1N1.

The dominance of pandemic flu has not been good for the youngest age groups, however. During week 46 of 2009 (the last for which CDC figures have been reported) 35 influenza-related pediatric deaths were reported. Twenty-seven of these deaths were associated with pandemic H1N1 infections, seven were due to an undetermined influenza A virus subtype, and one was associated with a seasonal H1N1 infection that occurred in March.

Clearly pandemic H1N1 has been harder on children and teenagers than on older people. The H3N2 virus, on the other hand, tends to kill the elderly. But only three cases of H3N2 were reported out of the 420 patient samples previously mentioned, meaning that the pandemic flu’s tendency to crowd out other strains has spared the older age groups, relatively speaking.

Since April, the H1N1 outbreak has killed about 4,000 Americans, according to CDC estimates, of which at least 230 were children under the age of 18.

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Even the Centers for Disease Control and Prevention (CDC) admits it: H1N1 swine flu is a mild disease for most people, but for those whom it hits hard, it is often fatal.

Approximately a third of those who die from the disease do so because of other complications—generally pneumonia or MRSA (methicillin-resistant Staphylococcus aureus) so that the two primary killers once H1N1 gets involved are S. aureus and S. pneumoniae.¹ In part, this reflects the fact—reported here earlier²—that pandemic H1N1 tends to go deeper into the lungs than seasonal flu. According to Dr. Sherif Zaki, a pathologist at the CDC quoted in the November issue of Nature,³ this particular property of the virus is similar to H5N1 avian flu, a far more virulent form of flu that scientists have feared for years might take on a highly contagious human form.

The good news is that this particular scenario has been slow to develop in nature, and may prove difficult to replicate even in the lab. Researcher Bruno Lina at the Jean Merieux/INSERM biosecurity facility in Lyon, France proposes to try to force recombination of H1N1 and H5N1 in the lab and test the survivability and virulence of any resulting products. Based on some of his previous attempts to reassort H5N1 with seasonal H1N1 and H3N2 and the fact that the two viruses in question are different subtypes, he doesn’t expect to find reassortments that are survivable.

Referring to his previous experiments with reassorting H5N1, Lina told Nature, “After a year we only had three reassortments, and none was fit. They just don’t reassort well.”⁴

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Even as a feeding frenzy surrounds the H1N1 swine flu vaccine, New Yorkers were confronted with the news that Wall Street banking firms Goldman Sachs and Citibank were given 200 doses of swine flu vaccine—the same quantity given to Lenox Hill Hospital.

Goldman and Citibank were not the only corporations given doses of the vaccine, and any companies receiving the vaccine had to have their own medical personnel in place. Also, the understanding was that the vaccinations would be given only to employees in the highest-risk groups, which includes pregnant women, children, and those with chronic diseases such as asthma.

Although the Centers for Disease Control and Prevention (CDC) is widely credited with the apparent gaffe, sources say the CDC gave the vaccine doses to the state, which dispensed them to hospitals, doctors, and corporations.

The video below from NBC’s Today show, summarizes the whole issue quite well, we think. For a more humorous approach to the subject, check out the Saturday Night Live clip below that.

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President Obama today declared the swine flu epidemic in this country a national emergency. Forty-six of the 50 states now have widespread flu contagion.

“It’s important to note that this is a proactive measure — not a response to a new development,” an administration official said.

“H1N1 is moving rapidly, as expected. By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly,” he said.

The Centers for Disease Control and Prevention (CDC) says that the extent of swine flu contagion in the U.S. is currently on a par with the peak of the seasonal flu season, which normally doesn’t occur until at least late November and sometimes not until early March.

By declaring the national emergency, the administration enables Medicare, Medicaid and other federal health insurance agencies to waive certain requirements. This will smooth the way for doctors, hospitals and clinics to treat patients. As the flu season peaks, health-care providers such as hospitals are expected to be overwhelmed with patients.

The table below shows figures from the CDC giving the breakdown of lab-analyzed specimens for last week. Note that out of nearly 5,000 positive specimens, over 99% were Type A and approximately 70% were swine flu. This latter figure is slightly misleading, however, because almost 30% of the samples determined to be Type A were not subtyped. This means that virtually all positive respiratory specimens that were analyzed last week have turned out to be swine flu if there subtype was checked.

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The World Health Organization (WHO) has acknowledged what regular readers of Health Spectator already knew: that the “new” H1N1 swine flu has a tendency to devastate the lungs in at least a significant portion of the people it infects. We reported on July 23 that University of Wisconsin virologist Yoshihiro Kawaoka had found H1N1 produces more severe lung lesions than seasonal flu in non-swine mammals.

The WHO currenlty puts the fraction of patients who need intensive care as a result of direct lung infection as high as 15%. Should the same prove true in the U.S. as the new wave of flu strikes this fall, it could put a strain on medical facilities.

The other distinctive trait of the new flu is its tendency to strike harder against the young. Whereas the elderly are normally most affected by seasonal flu, WHO is reporting that H1N1 infection is 20 times more common in the 5-to-24 age bracket than in those over 65. Some believe that the elderly have some natural resistance to the new flu from having been exposed to similar strains in the past. Others attribute the vulnerability of the otherwise healthy to the disease causing a so-called “cytokine storm,” which is an extreme reaction on the part of the immune system that causes more harm than the virus itself. Those with stronger, healthier immune systems are more likely to be severely affected, the reasoning goes.

Although WHO is also reporting a greater susceptibility to new flu among minorities and indigenous populations in South America, it is not clear whether a similar prevalence will result here in the United States. In other countries, the disparity may be the result of differing social conditions and medical care.

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