March 3, 2007, 10:44PM
Embattled FDA chief fights back
Von Eschenbach calls his agency 'a team few people fully appreciate'


By BENNETT ROTH
Copyright 2007 Houston Chronicle Washington Bureau

WASHINGTON — Dr. Andrew von Eschenbach, a former official at Houston's M.D. Anderson Cancer Center who has twice beaten back cancer, is facing another challenge as he struggles to right the ship at the tempest-tossed Food and Drug Administration.

With 12,000 employees and an annual budget of more than $2 billion, the FDA has enormous reach. It is responsible for approving the gamut of medical devices and drugs, from cancer treatment for humans to motion-sickness medicine for dogs. The agency, created just more than a century ago, is also charged with monitoring the safety of the bulk of the nation's food supply, recently issuing warnings about tainted spinach and peanut butter.

In an interview with the Houston Chronicle, von Eschenbach expressed frustration with the mounting criticism of his agency.

"It is a team few people fully appreciate. It is a team where people make decisions and immediately their motives are questioned," he said. "It is very hard for people to work under those conditions. How many cheerleaders have you seen on the streets for the FDA?"


Long confirmation fight
Von Eschenbach, who had been acting commissioner since 2005, was finally confirmed by the Senate to the permanent job in December but only after numerous holdups because of bipartisan criticism aimed at him and the actions of his predecessors.

Critics charged the FDA has succumbed to pharmaceutical industry pressures, leading to approval of drugs with dangerous side effects, such as the antibiotic Ketek, which has been linked to liver cancer.

Some lawmakers also accused the FDA of bowing to political pressure from social conservatives when it delayed approval of the Plan B "morning after" contraceptive pill for over-the-counter use after an expert panel had approved it. The drug was ultimately cleared last year for women 18 and older without a prescription after several Democrats threatened to block von Eschenbach's confirmation.

The agency's top officials, including von Eschenbach, have also been accused of stifling dissent and threatening whistleblowers. And it was recently disclosed that the agency is conducting half as many food-safety inspections as it was three years ago.

Von Eschenbach, who is fond of using sports metaphors and often refers to the FDA as his "team," acknowledged that he is dealing with an agency that is, in his words, enormously challenged as it labors to oversee 20 percent of what Americans consume.


A cancer story
He has sought to motivate agency scientists by stressing their vital role. The commissioner related the story of how one of his daughter's friends who had cancer had called him. The woman, who was having a birthday party for her 6-year-old daughter, told von Eschenbach she was running out of options and asked whether there was anything else to treat her cancer because she wanted to survive to be there for her daughter's next birthday.

"You are what will determine whether there will be anything else," von Eschenbach told his FDA employees. "There can be nothing else without the FDA. We regulate everything."

Raised in Philadelphia, von Eschenbach, 65, became a urologic surgeon and joined the faculty of University of Texas M.D. Anderson Cancer Center in 1976.

In 1989 he became a patient when it was discovered he had melanoma. He was later diagnosed with prostate cancer.


Friend of the Bushes
Rising to become the head of the Prostate Cancer Research Program, he became friends with former President Bush and former first lady Barbara Bush, who are supporters of the cancer center. Those ties proved beneficial when their president son tapped von Eschenbach to direct the National Cancer Institute in 2002.

In September 2005, President Bush appointed von Eschenbach acting director of the FDA to replace Lester Crawford, who last week was sentenced to three years' probation and fined $90,000 for lying about stocks he owned in companies regulated by the FDA.

Von Eschenbach has faced a rocky initiation at the FDA, but Dr. John Mendelsohn, president of M.D. Anderson, said that in conversations he has had with his former colleague, he appears to be holding up.

"He is accepting of the fact that there are going to be challenges and disagreements in government, but he bears it," said Mendelsohn.

Mendelsohn also said that von Eschenbach, a Roman Catholic, relies on his faith and his family, including his wife, Madelyn, for support.

Since taking over as permanent commissioner, von Eschenbach has moved to address some concerns by unveiling a plan to monitor safety of drugs for 18 months after they have been approved by the FDA.

The agency also restricted the use of Ketek for treatment of pneumonia. The administration has proposed adding $10 million in next year's budget for more food inspections.


Vaccine controversy
Von Eschenbach was acting commissioner when the FDA last summer approved the vaccine to protect women from the virus that causes cervical cancer. In Texas, the recent decision by Gov. Rick Perry to require girls 11 and older to receive the vaccine has sparked an uproar, with some opponents questioning the effectiveness of the vaccine.

While sidestepping the issue of whether it should be mandatory, von Eschenbach said the vaccine is "an opportunity for us to prevent this disease from occurring in the first place."

"We have a vaccine that is effective, and it is a vaccine that is safe," he said.

Some FDA scientists have expressed concern that the agency has tried to suppress warnings about safety of new drugs and intimidate whistleblowers. A survey published last summer by the Union of Concerned Scientists of 997 FDA scientists found that 40 percent feared retaliation for airing concerns about drug safety in public.

David Ross, a former FDA reviewer, told a House panel that von Eschenbach last summer summoned scientists who had reviewed Ketek after members of Congress had begun to question the drug approval. Ross said that Von Eschenbach, who was acting commissioner at the time, compared the FDA to a football team and told reviewers that if they told anyone outside the FDA about the problems with Ketek approval, they'd be "traded from the team."

Ross testified that rather than be silenced, he left the agency.

Von Eschenbach bristled at the suggestion that he doesn't allow the airing of different opinions. The commissioner said when he gave what he called "my locker-room talk" to the Ketek reviewers, he stressed that he wanted to hear diverse points of view during the deliberations but that once a decision had been made, "we go out on the field together."


What lies ahead
New challenges await the commissioner. Sen. John Cornyn, R-Texas, has joined with Democratic Sen. Ted Kennedy of Massachusetts in sponsoring legislation that would require the FDA to regulate nicotine as a drug.

Congress also will be considering the renewal of a 1992 law that assesses a fee on drug companies to help pay for FDA review of new drugs.

Revenue from industry fees, slightly more than $305 million this year, was intended to speed FDA drug reviews. Critics say the arrangement has resulted in the pharmaceutical industry getting too much sway in the approval process.

"He who pays the piper calls the tune," said William Vaughan, senior policy analyst at Consumers Union.

The drug industry has been a major player in the nation's capital.

The Pharmaceutical Research & Manufacturers of America spent $8.8 million lobbying the executive and legislative branches on drug-related issues during the last six months of 2006, according to PoliticalMoneyline.

Alan Goldhammer, vice president for regulatory affairs for the industry group, said the reliance on industry fees to underwrite part of the cost of drug reviews has not undermined the safety of drugs allowed on the market. He said the number of drugs, about 3 percent, withdrawn from the market has not changed since the law imposing the fees was enacted.

Von Eschenbach said he receives more input from consumer groups than the drug industry.

"The industry doesn't tell me what to do," he said.

Von Eschenbach, who has a vacation home on Lake Conroe, said he intends to return to the Houston area once his stint at the FDA is over. But he does not envision resuming his practice at M.D. Anderson, having not done surgery for five years.

He added, "I have no idea what life will have in store for me after the FDA."


BIOGRAPHY

• Born : Oct. 30, 1941
• Place of birth: Philadelphia

• Education: B.S., St. Joseph's University in Philadelphia in 1963; medical degree from Georgetown University in Washington D.C., in 1967

• Career highlights: Joined University of Texas M.D. Anderson as urologic oncology fellow in 1976. In 1983 was named chairman of the Department of Urology. Founded the Prostate Cancer Research Program and served as executive vice president and chief academic officer at M.D. Anderson. Appointed by President Bush to head the National Cancer Institute in 2002. In 2005, tapped by Bush to be acting commissioner of the Food and Drug Administration. Confirmed by Senate in December 2006 as permanent FDA commissioner.

IN HIS WORDS
Quotes from Dr. Andrew von Eschenbach, FDA commissioner:

•"You are really buffeted by an unbelievably diverse set of issues. One day you are dealing with some issue having to do with food. Another day it is drugs"

•"I think it is fair to say I am a surgical personality. What is important to me is the outcome. Are we making a difference in those people's lives and do(ing) it in a way that is efficient and effective"

•On speeding up drug approvals: "Rapid does not mean reckless. I believe we can create processes that will enhance the rigor and precision of decisions but do it in way that is actually faster. You put up guardrails, not speed bumps"

•On FDA approval of a vaccine for cervical cancer: "There are parts of this country where cancer of the cervix is a major cause of death, unnecessary death, of women. For many of them here's an opportunity for us to prevent this disease from occurring in the first place ... If you are asking me as a cancer doctor, 'Is this a major step forward?', I'd say absolutely. If you are asking me as head of the FDA, 'Do you believe this vaccine is safe and effective?', absolutely"



bennett.roth@chron.com



http://www.chron.com/disp/story.mpl/...s/4600344.html





Virginia to Require Vaccine for Girls
By
The Associated Press
Fri, Mar. 02 2007 05:20 PM ET


RICHMOND, Va. (AP) - Gov. Timothy M. Kaine said Thursday he would sign legislation requiring all sixth-grade girls to be vaccinated against the sexually transmitted virus that can cause cervical cancer.

Virginia would become the second state to mandate the vaccine for the human papillomavirus, or HPV, and the first to do it through legislative action. Texas Gov. Rick Perry sidestepped the Legislature and ordered the shots for girls there, but lawmakers are considering overriding that order.

"I think it strikes the right balance," said Kaine, who wanted to make sure parents would have enough time to review the vaccine and allow them to opt out "without having to jump through hoops."

The requirement would go into effect for the 2009 school year. If parents want to opt out, they must review literature provided by their child's school, then sign a form.

The federal government approved Gardasil, the only vaccine on the market, in June and suggested it be given to females before they become sexually active.

Copyright © 2007 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.



http://www.christianpost.com/article..._for_Girls.htm



March 3, 2007, 10:19PM
FDA poised to approve cattle antibiotic despite warnings
Agency likely will approve antibiotic despite fears it could harm people


By RICK WEISS
Washington Post



The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous — for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has ever been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board voted last fall to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.

Yet by all indications, the FDA will approve cefquinome this spring. That is all but required by a recently implemented "guidance document" codifying how to weigh threats to human health posed by proposed animal drugs.

The wording of "Guidance for Industry 152" was crafted within the FDA after a long struggle. Some say it makes it too difficult for the FDA to say "no" to some drugs.

"The industry says that 'Until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield (Wis.) Clinic Research Foundation. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."

The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts, it approved the marketing of Baytril and SaraFlox for use in poultry. Both are fluoroquinolones, drugs important for their ability to fight the bacterium that causes anthrax and the food-borne bacterium campylobacter, which causes a diarrheal disease in people.

Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. Abbott Laboratories pulled Saraflox, but Baytril's manufacturer, Bayer, pushed back.

Late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread further.



http://www.chron.com/disp/story.mpl/nation/4600179.html



MRSA and anti-biotic resistance



http://www.microbes.info/forums/index.php?showtopic=155



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