Archive for May 7th, 2008

Federal Stop-Smoking Guide Recommends Chantix

smokeThe new guidelines from the US Public Health Service arrive only a few months after the Chantix label was updated to reflect warnings about suicidal thoughts and behavior. Althlough the guidelines mention the psychiatric risks, they also say the Pfizer drug is the most effective at helping people get off cigarettes, the Associated Press writes.

The guidelines mention other options, and recommend combined counseling and medication, but docs are encouraged to tell smokers who want to quit about trying the pill. Consumer advocates cautioned the Chantix safety picture is incomplete because it’s only been available since 2006. “It is somewhat better than other therapies; on the other hand, it appears to have more risk,” Sidney Wolfe of Public Citizen tells the AP. “That part of the risk-benefit equation is missing, and it’s changing rapidly.”

Another issue with the quit-smoking guidelines is the lead author’s past connections with Pfizer. Michael Fiore, an expert on smoking and health issues, was a consultant to Pfizer, although he says he cut those ties in 2005. Three of 24 panelists who wrote the guidelines reported “significant financial interests” in the pharmaceutical industry, including speaking fees and stock ownership, the AP writes.

Fiore’s views are shaped by his past ties to the drug industry, and those ties still pose a conflict, according to one consumer advocate. John Polito, a smoking cessation educator who runs the WhyQuit.com site advocating quitting “cold turkey,” calls the revised guidelines “a sales pitch” for pharma.

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From The Lab To The Ice Cream Counter

cnbc-amgenWhat is former research scientist Gal Hever doing with those big spoons? The 35-year-old opened an ice cream parlor after being laid off by Amgen, which is in the process of shedding 2,600 jobs to cope with its crisis. His plight reflects the problems that will be picked over at Amgen’s annual meeting today. As CNBC’s Mike Huckman notes, some shareholders are unhappy and want to bounce Amgen ceo Kevin Sharer. You can watch here.

Glaxo Tries To Corner The Market On Weight Loss

fatThe drugmaker, which sells the Alli over-the-counter fat pill, has filed a citizen’s petition in hopes of convincing the FDA to change the rules governing health claims made by dietary supplement manufacturers. The gambit turns on the notion that weight-loss supplements should be vetted for claims that address a disease - and in this case, being overweight is a risk for various diseases.

In its petition (look here), Glaxo argues any claims that a supplement will reduce a risk factor for disease is, in fact, a disease claim and, as a result, weight-loss supplement manufacturers should be forced to substantiate their claims through petitions before selling their own pills. Which diseases are we talking about? High cholesterol, diabetes and high blood pressure.

“…many Americans understand the health risks of being overweight and they rely on dietary supplements to lose weight…There is little, if any, evidence, indicating that dietary supplements marketed for weight loss actually work. As a result of these three facts, many Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by ineffective weight loss supplements,” Glaxo writes.

“If FDA were to treat weight loss claims as disease claims, then manufacturers of weight-loss supplements would be required to obtain FDA review of their claims before rushing to market…by taking the actions requested in this petition, FDA would protect millions of Americans who are currently relying on unproven and ineffective dietary supplements to lose weight.”

Talk about a food fight. This is going to be quite a battle between pharma and dietary supplement makers, given the billions of dollars spent each year in the US by Americans who try to lose weight. In fact, the petition could spark an even wider war because it would cover claims by conventional foods.

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Glaxo Threatens Not To Invest In Massachusetts

glaxo-to-massGlaxo is playing hardball with Massachusetts. Chris Viehbacher, who heads the drugmaker’s North American pharma biz, sent what The Boston Herald calls “harshly worded letters” to three state politicans to accuse the state of a “strong anti-biopharmaceutical streak” and complains of attempts to “attack and demonize the industry.”

His ire was prompted by Senate President Therese Murray’s proposed ban on gifts to docs and, in his letters, Chris suggests Glaxo may not invest as much in the state if “political developments…devalue” assets there. His missives arrive just two weeks after Glaxo agreed to pay $720 million for Sirtris Pharmaceuticals, which is based in Cambridge. The two firms employ about 115 workers in Massachusetts.

A Glaxo spokeswoman wouldn’t tell the paper what would happen if “political developments” occurred. Yet Viehbacher’s letters - which were sent to Murray, Governor Deval Patrick and House Speaker Sal DiMasi - referred several times to “our current intent” to keep jobs in the state, while also calling Massachusetts the “most hostile state in the nation to biopharmaceutical sales.”

Viehbacher, who is based in North Carolina’s Research Triangle, praised Massachusetts as potential “fertile ground” for Glaxo due to its “great research institutions and a cluster of promising biotech companies.” And he went out of his way to praise Patrick’s proposed $1 billion life sciences initiative, the Herald writes. “At the same time, however, I must express my concern - and even alarm - about a strong anti-biopharmaceutical streak that seems to run through the Massachusetts political establishment.”

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How The FDA Will Spend Some PDUFA Fees

fdainthecrosshairs1Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports.

The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012), according to FDA News.

In a draft Drug Safety Five-Year Plan that the agency updates annually and issued for comment last Friday, the FDA signals its intention to use the fees to increase the number of employees dedicated to adopting new scientific approaches to drug safety, reducing the risk of medication errors and improving adverse event detection and prevention programs, FDA news continues.

The FDA blamed problems in adverse event reporting on “underreporting, the often poor quality of reports and the lack of systematic feedback to healthcare providers and consumers.” Mea culpa? So the plan calls for hiring a contractor “to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle,” FDA News writes.

Pharmalot… Pharmalittle… Catching Up

giftsDo you remember what the Morning Mayor used to say? Every brand new day should be unwrapped like a precious gift. So go ahead, open yours. And after you do so, grab a cup of something refreshing and take a peek at these…

Baxter Says Heparin Legal Costs Are Insignificant (The Chicago Tribune)

Roche Targets Diabetes To Replace Cancer Sales (Bloomberg News)

FDA Panel Rejects Wider Use of Cephalon Drug (Yahoo/Reuters)

Teva Seeks Judgment On Nexium Patents (Yahoo/Reuters)

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