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.

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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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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.

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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.”

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Just when vitamin D was beginning to look like the cure-all where cancer is concerned—many studies have proclaimed it instrumental in preventing or slowing cancers of the skin, colon, breast, and prostate, to name a few—a new study announced by the U.S. National Cancer Institute says increased vitamin D consumption does not correlate with reduced cancer mortality. The one exception, according to the study’s authors, may be cancer of the colon.

The study did not involve new research. Rather, it analyzed data for 16,818 subjects who participated in the Third National Health and Nutrition Examination Survey, which inducted participants between 1988 and 1994 and followed them through 2000. Participants were given blood tests to establish a baseline at the beginning of their enrollment; it was from these blood tests that the level of vitamin D (as 25-hydroxyvitamin D) was tested against decreased cancer mortality and found to be lacking. In the case of colorectal cancer, however, the study found a 72 percent reduced risk of death when vitamin D levels were sufficiently high.

The study, authored by D. Michal Freedman, Ph.D., of the National Cancer Institute in Bethesda, Md., and colleagues, was published in this month’s Journal of the National Cancer Institute. The authors believe it is the first study to test vitamin D blood levels—as opposed to supplement consumption—against cancer mortality.

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Reuters is reporting that a Senate panel has voted today to approve a path for getting generic biologic drugs to market faster. Biologics—unlike synthetics—are drugs that are derived from living things and are consequently often quite difficult and expensive to make. Because their manufacture is so sensitive to the slightest changes in starting substances or altered processes, there has to date been no mechanism in the U.S. for generic biologics to be produced, unlike the case with the more common “small molecule” drugs such as aspirin.

Perhaps the most commonly known examples of biologics would be vaccines. Less well known would be epoeitin alpha, a member of the class of erythropoietic proteins, marketed as Procrit (sold by Johnson and Johnson) and as Epogen, sold by Amgen.

The entire subject is fraught with controversy, with manufacturers who hold patents for biologics arguing that they cannot be duplicated in the same way that small-molecule drugs subject to traditional chemical manufacturing techniques are.

The area is also one with strong political overtones, as evidenced by the current Senate bill’s authors: Senators Edward Kennedy (D, Mass.), Hilary Clinton (D., N.Y.), Mike Enzi (R, Wyo.), and Orrin Hatch (R, Utah). No doubt democrats see a political windfall in breaking into the previously sacrosanct area of biologics.

The current Senate version of the bill would require generics manufacturers to run at least one clinical trial to demonstrate that their version of the drug was medically no different from the name-brand equivalent. However, a provision that may alarm the name-brand manufacturers allows the FDA to waive the clinical testing by relying on animal testing or other data.

What’s more, the FDA would have the power to declare a copycat drug as interchangeable, meaning that it could be substituted for its name-brand equivalent.

In order to qualify to become a generic, a drug must have been manufactured for at least 12 years and its patent must have expired. Most of the current controversy centers on the 12-year manufacturing requirement. Traditional drug-industry supporters see the time as too short, while generics manufacturers and consumer support groups argue it is too long.

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By now, most readers have heard of Andrew Speaker, the attorney infected with a dangerous form of tuberculosis who left the U.S. to be married in Greece despite attempts by health officials to keep him from traveling. Speaker was portrayed but not named in our May 30 report of the incident.

Since that time, Speaker has testified before Congress by phone and apologized publicly for the health scare he caused, claiming that doctors had told him he was not contagious. Emails obtained a few hours ago by the Associated Press portray a different view of the story.

The AP reports that Speaker’s father, also a lawyer, claimed not to know how to reach him when contacted by the CDC. His then-future father-in-law was urged by a CDC researcher to stop the wedding. Instead, he flew to Greece to attend it. The father in law, Robert Cooksey, is a CDC microbiologist.

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The New England Journal of Medicine is reporting that a man was injured by lightning while jogging and wearing an iPod. Doctors from the Vancouver General Hospital in Vancouver, B.C. report that the man suffered punctured eardrums, a broken jaw and second-degree burns on his chest, head, and left leg.

They attribute his broken jaw to the fact that the man was wearing the iPod, which caused the lightning strike (a side flash from a nearby tree) to pass through his head, causing a violent contraction of his jaw muscles. They stated that usually in lightning strikes of this nature, the high resistance of human skin keeps the flash traveling on the outside of the body.

The combination of body sweat and the metal from the iPod headset, however, caused the lightning to penetrate the jogger’s body, resulting in more substantial injuries.

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clipped from news.wjla.com A 19-year-old Chinese soldier has died of the virulent strain of bird flu, the country’s 16th reported death from the virus, the World Health Organization said Tuesday. The man, who was stationed in the southern province of Fujian, died Sunday after being hospitalized May 14 with a fever and a cough, said Joanna Brent, a spokeswoman for the WHO’s Beijing office.

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A ground beef recall so far affecting only Western states is in effect for beef originating from United Food Group and sold in 13 supermarket chains. The ground beef in question has been tainted with E. coli, a contaminant usually found as the result of poor slaughterhouse hygiene or practices.

So far, no one has died from eating the tainted beef, though four people have been hospitalized. E. coli contamination is of special concern for children under five and the elderly, who are most likely to be affected. So far, the illnesses have been reported in the five states of California, Arizona, Colorado, Wyoming, and Utah.

The ground meat is apparently being sold in tubes under the brand names Moran’s All Natural, Miller Meat Company, Stater Bros., Inter-American Products Inc., and Basha’s. Sell-by dates have been reported as April 20 to May 7, but recent reports indicate the beef may be tainted outside those sell dates, so consumers should be cautious. The supermarket chains involved include Albertson’s, Basha’s, Grocery Outlet, Fry’s, “R” Ranch Markets, Sam’s Club, Save-A-Lot, Save-Mart, Scolari’s Wholesale Markets, Smart and Final, Smith’s, Stater Bros. and Superior Warehouse Club supermarkets.

Sam’s Clubs were only stocked with the tainted beef in California, Arizona, and Nevada.

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