Health Spectator

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.

Currently, only two anti-virals are known to be effective against H1N1 pandemic swine flu: Tamiflu (oseltamivir) and Relenza (zanamivir). If not used sparingly, these too could become ineffective, the CDC has warned.

Both drugs can be used to prevent viral infection under the right circumstances, though the protocol currently recommended by the CDC is to use these drugs in this manner only to protect pregnant women, people undergoing chemotherapy, and similar groups who are known to be at higher risk of death from swine flu.

Recently, the doctor at a camp in North Carolina decided to immunize 600 campers by using Tamiflu. The result: two girls caught swine flu anyway, and tests showed that their strain had developed Tamiflu resistance.

Tamiflu is approved by the FDA for “treatment of uncomplicated acute (mild) illness due to influenza infections in patients 1 year and older who have been symptomatic for no more than 2 days.” The drug is also approved for prevention of influenza in patients 1 year of age and older. On August 4, 2009, the FDA commisioner released an Emergency Use Authorization (EUA) for Tamiflu because of the Public Health Emergency that was declared in the wake of the H1N1 (swine flu) epidemic.

That EUA enabled use of Tamiflu to treat and prevent influenza in patients less than 1 year of age. The EUA also allowed for use of Tamiflu at later time points (that is, in patients symptomatic for more than 2 days) and in patients sick enough to require hospitalization (severe illness).

Those seeking more information on the EUA and the current regulations surrounding the use of Tamiflu can find it on the CDC website.

The U.S. Department of Justice announced today that it had reached the largest settlement ever with a pharmaceutical manufacturer as Pfizer pled guilty to felony charges of fraudulent promotion of pharmaceuticals.

According to a DOJ press release, the company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn (subsidiaries of Pfizer) will also forfeit $105 million, for a total criminal resolution of $1.3 billion. The companies were misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005.

Misbranding in this case refers to the practice of recommending a drug for a purpose that has not been approved by the Food and Drug Administration (FDA).

The company also settled civil suits with the DOJ for violation of the False Claims Act as a result of illegally promoting four drugs—Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug—and causing false claims to be submitted to government health care programs for uses that were not medically accepted by the FDA and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these and other drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170.

The DOJ further stated that this is the largest civil fraud settlement in history against a pharmaceutical company.

“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,” said Kathleen Sebelius, Secretary of Department of Health and Human Services. “The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste.”

“Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars,” said Tony West, Assistant Attorney General for the Civil Division. “This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

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Turkeys in Chile have been infected with the H1N1 pandemic swine flu, news services have confirmed. The good news is that the effects on the turkeys are mild; they will be processed as usual for their meat and should be safe to eat.

But the spread of swine flu to birds is a step we have not wanted to see, particularly at this early stage of the game before more humans have had the chance to develop an immunity to the disease themselves. Once the disease becomes widespread in birds, it would seem to be only a matter of time before a more virulent strain emerges that is increasingly fatal to humans. Avian flu has consistently been the most dangerous to humans, and having a strain of flu that has already started making the rounds in humans also spread to birds does not promise good things for the future.

Chile’s health ministry said earlier today that it ordered a quarantine of two turkey farms outside the port city of Valparaiso. Health Spectator has been unable so far to determine if there are pig farms in the area, but we suspect there are. Modern factory farming practices tend to cluster pig and poultry farms in close proximity to each other, and Chile has long been a member of the factory farming club. We have also located photographs of a huge Chilean pig farm operation with a caption indicating that it is owned by Super Pollo (a company name that means Super Chicken).

As we noted in a story published earlier today (Factory farming is key to swine flu epidemic, below) factory farming practices have created a global situation in which new diseases evolve and spread more rapidly than previously possible, endangering both human and livestock populations.

Also earlier today, University of Missouri agricultural economist Ronald L. Plain said that since April, when the flu outbreak was first recognized in Mexico, hog producers have lost $500 million in revenue just because of the monniker “swine flu.”

The 4th International Public Conference on Vaccination will be held October 2-4, 2009 at the Hyatt Regency Hotel in Reston, VA (near Dulles Airport).

For registration and more information, visit the National Vaccine Information Center website.

The U.S. Food and Drug Administration (FDA) Tuesday announced its decision that mercury amalgam fillings—the so-called “silver” fillings most Americans have in their teeth—contain insufficient mercury to warrant concern.

“While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,” the FDA website proclaims.

A national group called Moms Against Mercury, along with three other organizations, had sued the FDA in 2006 to have mercury fillings removed from the U.S. market. Later that year, an FDA panel of outside experts voted 13-7 against two statements put to them regarding the FDA’s position that mercury amalgam fillings were safe:

The panel’s rejection of these statements caused quite a flurry among pro-mercury and anti-mercury forces alike. Those opposed to the use of mercury in fillings were heartened that at last the government might be listening. The American Dental Association (ADA), which has long favored the use of mercury fillings and supported the FDA’s position, was stirred to action over the possibility that mercury amalgam might finally be banned.

According to the FDA’s website, Tuesday’s ruling was the FDA’s final word on the subject, to the disappointment of those who were hoping to have mercury banned from dental fillings because of its proven adverse health effects.

Denmark Norway, and Sweden have banned the use of mercury amalgams. Several other countries do not allow the use of mercury fillings in young people under the age of 18.

To see a video entitled “How Mercury Causes Brain Neuron Degeneration” produced by the University of Calgary Faculty of Medicine, click here.

There will be an Internet radio show those of you interested in the National Animal Identification System (NAIS) will want to listen to today at 1 pm EDT. (Interestingly, the local time zone is not posted, but it’s at 5 pm UTC. So check my math: that’s 1 pm EDT and you can take it from there for other time zones.)

Here is the blurb from John Wallace’s website:

My guest on this show will be Paul Griepentrog, a local farmer from Wisconsin. Paul has been fighting the federal government and the Wisconsin government against NAIS and fake food safety. He has successfully filed an AMICUS brief on behalf of an Amish farmer he doesn’t know but who had been targeted by US Dept of Agriculture (USDA).

The USDA has paid the state of Wisconsin $14 million in what they call a cooperative agreement (bribe) to mandate “Premises ID” in Wisconsin and the state has recently announced that it is on the verge of moving to Phase 2: Mandatory NAIS “tagging.” (more…)

There is evidence that the polyphenols found in green tea may slow the progression of prostate cancer, according to a study published recently in Cancer Prevention Research,¹ a journal of the American Association for Cancer Research (AACR).

According to researcher James A. Cardelli, PhD, professor and director of basic and translational research in the Feist-Weiller Cancer Center, LSU Health Sciences Center, Shreveport, LA, men with prostate cancer who consumed the active compounds in green tea demonstrated a significant reduction in serum markers predictive of prostate cancer progression.
(more…)

Excessive sodium, stress, lack of exercise—now add cytomegalovirus to the list of possible causes of high blood pressure. CMV, a common type of herpes virus (an estimated 50-85% of adults are infected by age 40, according to one source) has also been linked to hardening of the arteries and may even be implicated either directly or via its effects on the immune system in autism. In fact, blood pressure may be the least of your worries if this nasty virus has taken up residence in your system. (more…)

Researcher Deborah Barnes of the University of California, San Francisco, thinks she has a tool for discovering who among the over-65 set is at risk for developing Alzheimer’s Disease within the next six years. According to Reuters, Barnes claims her checklist has been 88% accurate to date in predicting who will subsequently develop the dreaded degenerative disease. (more…)