Auburn University

Wednesday, May 3, 2006

Good morning! Here's your daily summary of news coverage of Auburn University.

Total Clips: 4
Headline Date Outlet
   Steeplechase funds arts groups 05/03/2006 Columbus Ledger-Enquirer
   Graysville unveils strategy for managing city growth 05/03/2006 The Birmingham News
   AU faculty less critical of Senate than thought 05/03/2006 Opelika-Auburn News
   New controversy over menopause hormones 05/03/2006 Pittsburgh Post-Gazette


Steeplechase funds arts groups
05/03/2006
Columbus Ledger-Enquirer

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**Article mentions AU's College of Veterinary Medicine as one of several beneficiaries of the 2005 Steeplechase at Callaway Gardens.**

The 2005 Steeplechase at Callaway Gardens raised $160,000 that is benefiting arts organizations in west-central Georgia.

A check recently was presented to the Ida Cason Callaway Foundation Inc., parent organization of Callaway Gardens. The funds are being shared by benefactors including the foundation, Columbus Museum, Columbus Symphony Orchestra, Springer Opera House, Historic Columbus Foundation Inc., Chattahoochee Valley Art Museum and the Auburn University Veterinary School.

"We are grateful for our long-standing relationship with the Steeplechase organization and its many hard-working volunteers," said Edward Callaway, the Callaway Foundation's chairman of the board of trustees.

More than $2.1 million has been raised for the arts during the 21-year history of the Steeplechase. The 22nd running will be Nov. 4.
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Graysville unveils strategy for managing city growth
05/03/2006
The Birmingham News
Ryan Mills

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**Story mentions that AU Economic Development Institute prepared an economic assessment report for Graysville.**

Graysville's strengths and opportunities include affordable housing, low crime, likely economic development from I-22, and annexed land available for development, according to the city's new comprehensive plan.

Its weaknesses and threats include overcrowded schools, limited shopping opportunities, low income levels and the possible resumption of the Adamsville landfill, according to the plan.

About 70 Graysville residents gathered recently at the Maurice C. West Community Center for a public presentation of the document.

The plan was completed by the Regional Planning Commission with input from the city. It is an update of Graysville's original comprehensive plan, which was completed in 1976. The city paid the RPC about $10,000 to complete the plan, said Mayor Doug Brewer.

The city also commissioned an economic development assessment report with the assistance of the Auburn University Economic Development Institute.

Brewer said the decision to update the city's plan was made in November 2004, one month after he was elected.

With the extension of Interstate 22 planned to reach Graysville in the next two years and the Northern Beltline proposed for the area, Brewer said, it was time to start planning for the future.

"You always put yourself in the position to win, and that's what we want to do with the comprehensive plan," Brewer said.

The 52-page plan has sections on demographics and growth projections, community visioning, community policies and policy implementation.

RPC Senior Planner Jason Fondren said one of Graysville's most significant opportunities would be a revitalized downtown. Also, when I-22 opens, Graysville will be a more attractive home for people who work in the Birmingham metro area, Fondren said.

"It's a quiet community, but it is going to have really great access for people to get back and forth in terms of commuting," he said.

Brewer said he hopes the plan will help the city grow and progress.

"It's no great secret that we need a shot in the arm," Brewer said. "We feel that with I-22 coming through, that's going to be our best opportunity in almost 50 years. Downtown revitalization is the key to our city."

Mary Blackstone, who has lived in Graysville for most of the past 50 years, attended Monday's presentation and said she was impressed by the turnout. She said she would like to see more homes and businesses - specifically a grocery store - in the city.

"Change comes and we have to accept change," Blackstone said. "It will get better. It just takes time and people working together."

Brewer said the next step is for the Graysville Planning and Zoning Board to recommend that the City Council adopt the plan. The council should vote on it by the end of May, he said.
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AU faculty less critical of Senate than thought
05/03/2006
Opelika-Auburn News
J. Frank Lynch

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**Opelika-Auburn News' coverage of Tuesday's University Senate meeting.**

Members of the Auburn University Senate found out Tuesday what some of their fellow faculty members really think about them - and as it turns out, the opinions weren't so bad.

The results of a nine-question Web-based survey conducted last month by the university's Center for Governmental Services were dissected at Tuesday's Senate meeting, the last of the academic year.

The non-scientific, non-binding survey came in response to observations made in the Fisher Report about whether the Senate is truly representative of the university at large. Consultant James Fisher noted a history of strained relations among Senate and rank-and-file faculty in his 150-page review, conducted over two months in December and January.

But Conner Bailey, immediate past chair of the Senate, had good news to deliver as he summarized the survey's findings for fellow Senate reps Tuesday.

"Your colleagues like you - that's the good news," said Bailey. "Nearly two-thirds thought you did a good job. There's room for improvement, of course, but three-quarters said you do a good job keeping them informed and reporting back on Senate business."

As for opinions on Senate officers, "There was both glowing praise and stern damnation," Bailey said.

Of the nearly 2,000 instructional employees who were invited to take part in the survey, 466 responded, Bailey said.

Further, when broken down by length of tenure at AU, about 68 percent reported 10 or more years, while 16 percent each reported five to 10 years, or less than five years.

"That's pretty much what our faculty looks like," Bailey said.

Of those, about two-thirds claimed no Senate experience.

"One of the more interesting points we raised - and this came out of the Fisher Report - was whether the Senate should represent faculty exclusively," Bailey said.

The survey results offered no clear answer, he said, but instead showed opinions for or against about evenly split, with nearly 25 percent of respondents sharing no opinion at all.

"That's something to look into later, when we get a new president on campus and can address the faculty handbook," Bailey said. "I wouldn't call these troubling, but I think we should look at these comments and consider ways to better include the faculty. It's a pretty diverse group."

Among some of the other key findings:

* Almost four-fifths of participants indicated that the current three-year Senate term is about the right length.

* Two-thirds agree that Senators should be allowed to serve two consecutive terms even if Senate terms continue to be three years.

* Two-thirds agreed that Senators representing their academic units solicit input in advance of votes or discussions on important matters.

* Over three-fourths stated that their Senators report back to their academic departments after Senate meetings.

* Most agreed that holding Senate meetings at any other time of the day wouldn't increase their likelihood of attending the meetings.

Office of the Provost John Heilman put up the funding for the survey. Afterward, he said the results provided worthwhile food for thought.

"Having paid for this, I think the results were well worth the cost," Heilman told the Senate.
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New controversy over menopause hormones
05/03/2006
Pittsburgh Post-Gazette
Tara Parker Pope, The Wall Street Journal

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**This story, which originally appeared in Tuesday's Wall Street Journal, references a study by Lisa Boothby, an affiliate clinical assistant professor in AU's Harrison School of Pharmacy.**

An unusual petition before the Food and Drug Administration has triggered a huge outpouring of responses from women, doctors and pharmacists, protesting a bid to crack down on certain menopause hormones.

The flood of more than 40,000 emails and letters over the past six months underscores how emotional the issue of menopause hormones has become, and raises questions about the growing industry of small-scale drug mixers who are making hormone medications from scratch.

Pharmaceuticals giant Wyeth, the biggest seller of prescription menopause hormones, has asked the FDA to take action against makers of pharmacy-mixed -- or "compounded" hormones -- which it says aren't being adequately regulated. The company contends many compounders make false claims about the drugs' safety and fail to tell women about the risks associated with hormone use.

These compounded medications, which use custom doses of plant-based hormones, are regarded by many women as safer and more natural than the commercial hormones made by drug companies. The custom drugs are often called bio-identical hormones because they are chemically similar to a woman's natural hormones. They have surged in popularity since a government study four years ago raised questions about the health risks associated with traditional menopause hormones made by drug companies, including Wyeth.

The FDA has said that women should assume all estrogen and progestin drugs carry similar health risks. The agency has yet to respond to Wyeth's request, other than saying it needs more time to review the issue. Whatever the FDA decides, it will have dramatic implications for the compounding industry and women's health.

Compounding pharmacies have been a niche industry that serves an important function in the health-care system, preparing custom-mixed drugs for patients who for some reason can't use drugs manufactured by pharmaceutical companies. For instance, compounders might make a chewable tablet or dye-free version of a medicine for patients with special needs. Many patients with allergies to certain drug ingredients, or who want medications no longer manufactured on a large scale, say compounders provide treatments they just can't get anywhere else.

Now, the interest in customized hormones has transformed the compounding industry into a significant player in menopause treatment. The question being raised by Wyeth is whether the business has reached a scale that means many compounders are acting more like a drug manufacturer than a corner drugstore, and thus should be regulated by the FDA.

"As a pharmaceutical company we're highly regulated, and we're sitting here watching people get prescriptions for things that aren't adequately tested or that they aren't being adequately warned about," says Ginger Constantine, Wyeth vice president for women's health care. "If the FDA takes a look and says, 'We don't see any problem here,' then so be it, but we need to raise the issue."

Nobody knows how much of the prescription hormone market now goes to compounders, but the size of the consumer reaction to the Wyeth complaint suggests that compounders are providing drugs to a large number of women. Sales of commercial prescription drugs have fallen by about half since 2002, when the first health risks were reported, to about $2 billion in annual sales now, according to consultants IMS Health.

What is also clear from the comments received by the FDA, is that many women are convinced compounded hormones are safer and more effective than commercial hormones. The overwhelming majority of responses were in protest of Wyeth's petition, and were the result of a grassroots effort in pharmacies and on Web sites to urge women and doctors to write to the FDA. An FDA staff person said there is a backlog of comments to be posted to the agency's online docket and the final number may exceed 50,000.

"There is no public risk to health, since these hormones are merely replacing what was lost due to age, diet, or environment," reads one response on the FDA docket. "These are the exact hormones that should be in the body, not synthetics, so (they) are much easier absorbed and assimilated by the body than other manufactured products."

Pharmacy groups and doctors who prescribe compounded hormones accuse Wyeth, which makes the biggest-selling hormone drugs Prempro and Premarin, of trying to shut down its competition, and say the effort threatens the health of patients who rely on compounded drugs.

"There are millions of women's lives and health involved in this," says Steve Metcalf, owner of Metcalf Pharmacy in Brevard, N.C., and one of the firms cited in the Wyeth complaint. "To remove the option for ladies who choose it and doctors who prescribe it is unfair to the public."

One reason many compounders are concerned about the Wyeth action is the company's track record. In 1994 Wyeth filed a similar request urging the FDA to reject an application for a generic version of Premarin on the basis that it wasn't chemically identical to the branded drug. In 1997, the FDA ruled in Wyeth's favor, effectively squelching all generic competition to Premarin.

Whether the FDA has any say this time around is a matter of debate. The compounding industry operates in something of a regulatory vacuum. Pharmacy practices are regulated by state pharmacy boards, while the FDA has purview over the drug-making business. In recent years the FDA has focused its enforcement actions against pharmacies to those linked with tainted products, those selling drugs on a large scale or those involved in some type of fraud.

Before bioidentical drugs are prescribed, a doctor typically performs a saliva test, which measures a woman's natural hormone levels. The belief is that the saliva test allows a doctor to better determine what hormones are in short supply in a woman's body. They then can prescribe a customized hormone mix that they say will do a better job relieving menopausal symptoms with fewer side effects than commercially prepared hormone drugs.

"All hormones aren't created equal," says Erika Schwartz, a New York physician who prescribes compounded hormones. "It's what kind of hormone supplementation you use and how you balance it that makes a difference. I've taken bioidentical hormones myself for 10 years."

Critics of the Wyeth complaint say an important point being ignored is that the pharmacies are only dispensing prescriptions written by doctors.

"The doctors are the ones asking us to provide the service -- it's not just us saying we'll make it and handing it out to anybody who wants it," says Derick Anderson, a compounding pharmacist in Brookline, Mass.

But the saliva tests and follow-up visits can get expensive. The initial doctor visit can range from $200 to $400, with follow-up visits, costing $125 to $250, needed about every three months until a woman's hormones are considered "stable." Lab work each visit can cost $100 to $400, while the hormones cost $30 to $100 monthly. Unlike with prescription hormones, many of the costs aren't typically covered by insurance.

Groups like the North American Menopause Society and the American College of Obstetricians and Gynecologists have said there is no evidence that compounded hormones are better or safer than commercial drugs. In addition, they have raised questions about whether compounded drugs have been adequately tested.

"The American Medical Women's Association is concerned about the safety and purity of these unregulated compounds and about misleading claims related to the marketing of some of these ... products," wrote Linda Hallman, AMWA executive director, in a recent letter to the FDA supporting the Wyeth petition. "For these compounded products, there is no regulation of production, purity of product and safety of dose, nor safety and efficacy studies."

Some doctors also question the reliability of saliva testing, saying that a woman's hormone levels vary dramatically and there is no evidence that hormone levels detected in saliva tests have anything to do with a woman's symptoms.

In 2004, the medical journal Menopause reported on a review of bioidentical hormones that concluded saliva tests weren't a reliable way to determine a woman's hormone needs. The report concluded that compounded hormones are "potentially harmful," and lack "scientific underpinning." The paper's lead author, Lisa Boothby, affiliate clinical assistant professor at the Auburn University Harrison School of Pharmacy, says she has no financial relationships with any drug firms.

The fact that major medical groups are skeptical about bioidentical hormones hasn't dissuaded doctors from prescribing them or women from using them.

One woman wrote to the FDA that she has been taking bioidentical hormones for four years "with great results." "I feel I am protecting myself from cancer and God knows what else," she wrote.
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