#5 & #6, Halfway there

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Impeach George Bush

#5 & #6, Halfway there

Source: Alternet, 2005-01-26

Candidate: Big Government

GlaxoSmithKline: Deadly Depressing

GlaxoSmithKline, Paxil and selective serotonin reuptake inhibitors (SSRIs): It was the story that foreshadowed and strikingly paralleled the controversy surrounding Merck, Vioxx and Cox-2 inhibitors.

With the antidepressant Paxil (generic name: paroxetine), the story was driven primarily from the United Kingdom, by the BBC program Panorama and a public interest group called Social Audit. They called attention to the severe side effects from the drugs; notably that they are addictive and lead to increased suicidality in youth.

In 2003, the evidence of dangerous side effects had piled too high for British regulators to continue to ignore them. In June, the UK health experts advised that children should not be prescribed Paxil.

In February 2004, Panorama reported on internal documents from GlaxoSmithKline (GSK) showing the company knew that Paxil could not be proved to work in children.

In March 2004, days after the Medicines and Healthcare Products Regulatory Agency (the UK's drug regulatory agency) advised that Paxil dosages should be kept to low levels, an expert participating in the Paxil review resigned, claiming the agency had possessed evidence for more than a decade suggesting that Paxil dosages should be kept low, but failed to act on it.

By this time, the story had started to heat up in the United States. Dr. Andrew Mosholder, of the FDA Office of Drug Safety, had conducted an analysis of clinical trials related to antidepressant use in children, and found a heightened risk of suicidality. But his superiors refused to let him present his findings to an advisory panel convened to look at the issue in the wake of the British action.

According to an investigation by Sen. Charles Grassley, R-Iowa, the FDA actually tried to get Mosholder to present data that deceptively underrepresented the risk of suicidality.

Although Paxil is not approved by the FDA for prescription to children, doctors routinely write "off-label" prescriptions for the product for children, a practice permitted under FDA rules. More than two million prescriptions for Paxil were written for children and adolescents in the United States in 2002.

In April 2004, the Lancet, the prestigious British medical journal, published a paper showing that clinical test data did show problems with prescribing Paxil and other SSRIs to children.

In June, New York State Attorney General Eliot Spitzer filed suit against Glaxo, charging the giant drug maker with suppressing evidence of Paxil's harm to children, and misleading physicians.

GSK responded in a statement that it "acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies. All pediatric studies have been made available to the FDA and regulatory agencies worldwide."

Spitzer's complaint cited a 1998 GSK memo which states that the company must "manage the dissemination of these data in order to minimi[z]e any potential negative commercial impact."

Responding to Spitzer's suit, GSK claimed that, "As for the 1998 memo, it is inconsistent with the facts and does not reflect the company position."

The New York complaint asserted as well that "GSK has repeatedly misrepresented the safety and efficacy outcomes from its studies of paroxetine as a treatment for MDD [Major Depressive Disorder] in a pediatric population to its employees who promote paroxetine to physicians."

In August, the company settled with Spitzer for $2.5 million, plus a commitment to maintain the policy of posting clinical trial results, for all drugs marketed by the company.

The next month, the Star-Ledger of New Jersey reported on a Glaxo memo from the year before, instructing the company's sales force not to talk to doctors about company data showing dangers from prescribing Paxil to kids.

In October, the FDA ordered Glaxo and other SSRI makers to include a "black box" warning with their pills. The warning says SSRIs double the risk of suicide in children, though some medical researchers say the number should be higher. At least one GSK clinical trial showed 7.5 percent of youth taking Paxil suffering from suicidality (versus zero percent among those taking a placebo).

Glaxo continues to insist that it disclosed information to appropriate authorities as soon as it discerned important results from its clinical studies.

Hardee's: Heart Attack on a Bun

When Hardee's introduced the Thickburger this year, Jay Leno joked that it was being served in little cardboard boxes shaped like coffins.

With other major fast food outlets moving to green salads, Hardee's revels in big beef. From Hardee's press release of Nov. 15, 2004:

Now Hardee's is introducing the mother of all burgers � the Monster Thickburger�. Weighing in at two-thirds of a pound, this 100 percent Angus beef burger is a monument to decadence, yet is still a throwback, as it features lots of meat, cheese and bacon on a bun.

Clearly, Hardee's, a subsidiary of CKE Restaurants, Inc. of Carpinteria, Calif., is not worried about the public health aspects of unleashing the monster into the marketplace.

Eating one Thickburger is like eating two Big Macs or five McDonald's hamburgers. Add 600 calories worth of Hardee's fries and you get more than the 2,000 calories that many people should eat in a whole day, according to Michael Jacobson of the Center for Science in the Public Interest.

The Federal Trade Commission (FTC) earlier this year charged KFC Corporation, owner of the Kentucky Fried Chicken national restaurant chain, with making false claims in a national television advertising campaign about the relative nutritional value and healthiness of its fried chicken.

The false claim? KFC said that eating fried chicken, specifically two Original Recipe fried chicken breasts, is better for a consumer's health than eating a Burger King Whopper.

The FTC says that while it is true that the two fried chicken breasts have slightly less total fat and saturated fat than a Whopper, they have more than three times the trans fat and cholesterol, more than twice the sodium, and more calories.

KFC settled the case.

But there will be no law enforcement action brought against Hardee's. Hardee's makes no pretensions that the Hardee's Thickburger is good for you, and has no qualms about the impact of the monster on the public's health. The fast-food pusher's new advertising campaign is straight up: "Be afraid. Be very afraid."

As The New York Times put it in an editorial, "It is a setback for public health, but a triumph for truth in advertising."
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