NEW YORK–(BUSINESS WIRE)–Jan 6, 2009 – Pfizer Inc announced today that the U.S. Patent & Trademark Office has issued a “Notice of Allowance” accepting the company’s application to correct the technical defect in the ˜995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor. The company noted that certain formalities must be completed before the reissue patent will be granted. The reissued patent will have the same force and effect as the original ˜995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).
“This is a very positive development, not just for Pfizer but for all those who believe that defending intellectual property is vital to supporting the enormous investments required to develop life-saving new medicines,” said Raymond F. Kerins, Jr., vice president, Worldwide Communications, Pfizer. “We have said all along that we had strong arguments for securing the reissue of the patent, and after a vigorous and thorough examination, the Patent Office agreed with this conclusion.”
More information regarding Lipitor can be found at www.pfizer.com.
By David Brown
Washington Post Staff Writer
Monday, January 12, 2009
In our information-crazy, never-out-of-touch world, it’s becoming harder and harder to find out who we are and what we do.
That’s the ironic truth facing epidemiologists around the country.
The popularity of cellular telephones, an increasingly mobile population, rising expenses, flat budgets and new insights into ways people can answer a question differently depending on how it’s asked — all are conspiring to make health surveys more difficult.
In public health, pretty much everything depends on good data. Researchers and policymakers can’t identify a problem, figure out whether it’s serious and devise a strategy to fight it without first being able to count it. “If you can’t measure something, you won’t be able to change it” is an oft-heard aphorism.
How big a problem is obesity? Are restrictions on smoking changing people’s habits? Is autism more prevalent than it was a decade ago? Is the recession affecting people’s access to health insurance?
All are questions of national importance — and none can be answered without unbiased surveys of a representative sample of the population.
Cellular telephones are perhaps the biggest threat to survey data that epidemiologists have confronted in years.
The National Center for Health Statistics reported that in the first half of last year, 16 percent of American adults lived in households that have only cellphones. This was up from 7 percent three years earlier, and rising rapidly.
The federal government’s main tool for measuring the health habits of Americans, the Behavioral Risk Factor Surveillance System (BRFSS), uses the telephone to interview a nationwide sample of adults (470,000 this year). Historically, interviewers called only conventional telephones, as all but the 2 to 3 percent of households with no phones at all could be reached through them. But that’s not remotely true anymore.
Surveyors, however, cannot just extrapolate from the land-line respondents. That’s because studies have shown that people who have only cellphones are different from people who don’t have them or use them only occasionally.
Young people, men and Hispanics are all more likely than the “average” American to have cellphones only. But those demographic factors don’t explain everything. Even after they are taken into account by statistical means, cellphone-only users are different.
The BRFSS surveyors this year will include cellphone numbers in every state, with a goal of having 10 percent of the interviews done that way. But it’s easier said than done.
Federal law requires that calls to cellphones be hand-dialed; it is illegal to use automatic dialers, which are standard tools for survey and polling firms. Furthermore, a huge fraction of “owners” of cellphone numbers are children ineligible for the health surveys. Once reached, some cellphone users are reluctant to talk at length because they have to pay for incoming calls.
Consequently, it takes roughly nine calls to working cellphone numbers to get one completed survey, compared with five calls to working land-line numbers, said Scott Keeter, a polling expert at the Pew Research Center for the People and the Press, an independent opinion research group. Further, an interview conducted with someone who uses a cellphone costs 2 1/2 times as much as an interview with someone on a conventional phone. In addition to higher labor costs, most surveys now reimburse cellphone users for their minutes, either in cash or through credits to online merchants such as Amazon.com.
People’s willingness to answer questions has also been affected by the barrage of phone calls, many unsolicited, they get every day. The response rate in public opinion polls has fallen from about 60 percent two decades ago to 25 percent now, according to Keeter.
Government-sponsored health surveys have fared better. The “cooperation rate” for the BRFSS in 2007 was 72 percent, the same as in 1994. The smaller, in-person National Health Interview Survey had a response rate of 87 percent in 2006. A decade earlier, it was 92 percent.
But the problem goes beyond changing technology and responsiveness. It turns out that people answer the same question differently depending on how you reach them — a “mode effect.”
For example, when a group of people with the same age, race and education are called on a conventional phone, 25 percent say they smoke, but on a cellphone 31 percent say they do. On a land line, 38 percent say they have been tested for HIV, while on a cellphone 54 percent say they have.
The reason for this is unclear. Ali H. Mokdad, an epidemiologist who until recently was at the federal Centers for Disease Control and Prevention and ran the BRFSS, speculates it may have something to do with the fact that people on land lines are usually at home, where they have a role and image to maintain even if they are answering in privacy.
“They are less likely to say something bad about their own behavior. It’s like ‘This is my house,’ ” he said.
A study published three years ago showed that when women were interviewed by phone, rather than in person, they tended to underreport their weight, and both men and women (but men more) tended to overreport their height. Both estimates were exaggerated — women’s weight lower and men’s height higher — compared with surveys in which height and weight were measured.
The study showed the importance of using measurements to determine the national prevalence of obesity, as interview data alone substantially underestimate it.
The internal architecture of a survey can also affect the results.
Where a question falls in a series of them can increase the likelihood of a certain answer, a phenomenon known as “differential item functioning.” The ethnicity of the respondent may also make a difference. According to a study published in 2006, Hispanics are more likely to give answers at the extremes of numerical scales “because of a cultural value that associates extreme responses with sincerity.”
In all, what seems like a fairly simple and straightforward task is in truth hard and messy.
“It’s a bit like making sausage,” said Christopher J.L. Murray, a physician and epidemiologist who heads the Institute for Health Metrics and Evaluation at the University of Washington.
“As soon as you start to explore how surveys are made,” he said, “you begin to see how difficult it is to get consistent information at the population level over time.”
By Jeffrey Kluger Saturday, Jan. 10, 2009
Jason Edwards / National Geographic / Getty
To the long list of reasons you should be glad you’re not an ant, add this: You’d have to forget about having sex. You’d also have to forget about even trying. Sneak off for a little insectile assignation and the others members of the colony would know immediately — and attack you for it. Entomologists have long known this was the practice in the ant world, but what they didn’t know is the forensic science that allows the community to uncover the crime. Now, thanks to a study in the current issue of Cell Biology, they do.
Ant colonies have good reason to be abstemious places. When you’re trying to hold together so complex a society without — let’s face it — a lot of brainpower, you want a population made up of the fittest individuals you can get. A queen that has the genetic mettle to crank out lots of good eggs that produce lots of good babies doesn’t need any competition from other, lesser females setting up a nest nearby. Even the queen herself is not allowed to fool with the gene pool once it’s been set. She mates only once in her life and stores all of the sperm she’ll ever need for the thousands of eggs she’ll produce.
The rules, of course, don’t prevent the other ants in the colony — which spend their lives tending eggs, gathering food and digging tunnels — from feeling a little randy now and then (never mind the fact that they’re all, genetically speaking, brothers and sisters). But not only are those who give into the procreative urge pounced on by the others, those who are even considering it are often restrained before they can try. The tip-off, as with so many other things in the animal world, appears to be smell.
Earlier studies had shown that a queen that senses potential competition from another fertile female will chemically mark the pretender; that female will then be attacked by lower-ranking females. Biologists Jürgen Liebig and Adrian Smith of Arizona State University suspected that something similar might go on even without the queen’s intervention and believed the answer might lie in scent chemicals called cuticular hydrocarbons.
Ants that are capable of reproducing naturally emit hydrocarbon-based odors, and the eggs they produce smell the same way. Ants that can’t reproduce emit no such odor. Liebig and Smith produced a synthetic hydrocarbon in the lab that had the same olfactory properties as the natural one, then plucked a few completely innocent ants from a nest and dabbed the chemical on them. When they were returned to the colony they were promptly attacked — never mind that they had essentially been framed.
The sexual environment does sometimes loosen up in ant colonies. While the place may never become a Caligulan free-for-all, collective breeding will resume if the queen dies or is experimentally removed — but only until a new queen establishes herself and the reproductive lockdown resumes.
Complex critters like us might be glad to be part of a species that’s free of such Draconian sexual rules, but Liebig doesn’t think it’s wise to get above ourselves. All manner of lawsuits, divorces and blood feuds have erupted over people breeding when — or with whom — they oughtn’t. Often, the methods used to expose the cheaters aren’t terribly different from those of the ants: more than one philanderer, after all, has been exposed by a whiff of the wrong perfume on his clothes when he came home. “The idea that social harmony is dependent on strict systems to prevent and punish cheating seems to apply to most successful societies,” Liebig explained in a comment released with his paper. Regardless of the genome, in matters of sex, nature still appears to prefer us not to stray.
Medscape Medical News 2009. © 2009 Medscape
January 12, 2009 — Julie L. Gerberding, MD, MPH, resigned as director of the Centers for Disease Control and Prevention (CDC) in a Friday night email to employees of the US Department of Health and Human Services (HHS), the umbrella agency for CDC.
Her more than 6-year tenure has been marked by controversy. Supporters praised her communication skills with legislators and the public and acknowledged that she improved the agency’s ability to respond to public health crises. Detractors criticized her for kowtowing to Bush administration political positions to the detriment of the agency’s scientific agenda and for leading a morale-damaging reorganization of the CDC that led to an exodus of high-level scientists.
Dr. Gerberding will be replaced by interim director William Gimson, CDC’s chief operating deputy, on January 20, President-Elect Barack Obama’s inauguration day. No permanent replacement has been named yet, but public health experts are speculating about who her successor might be.
Dr. Gerberding was the first female head of the CDC, an agency mandated to investigate disease outbreaks, research the cause and prevalence of public health problems, and promote illness prevention. The CDC won high marks from a 2007 Harris Poll, rating it as the government agency that does the best job. Dr. Gerberding was also director of the CDC’s sister organization, the Agency for Toxic Substances and Disease Registry. Both agencies have a combined budget of about $8.8 billion and more than 14,000 full-time, part-time, and contract employees.
Dr. Gerberding was traveling in Africa and could not be reached for comment, according to a report in the New York Times. CDC spokesman Glen Nowak prepared the following statement: “As part of the transition process, the Administration requested resignation letters from a number of senior-level officials, including Dr. Julie Gerberding. This week, the Administration accepted Dr. Gerberding’s resignation, effective January 20th.”