AMERICAN YOUTH VOTED FOR KERRY

Something to think about for the FUTURE of America.

FDA Scientists Think Drug Industry Threatens Public Safety

Survey: FDA scientists question safety

By Julie Schmit, USA TODAY

Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.

And 18% of the almost 400 respondents said they had been pressured to approve or recommend a drug despite reservations about its safety, effectiveness or quality.

The survey, conducted by the Department of Health and Human Services (HHS) Office of Inspector General, was partially released last year. An advocacy group released the full report, acquired via the Freedom of Information Act.

The survey's details come amid rising criticism that the FDA puts too much emphasis on getting drugs to market and too little on protecting consumers from unsafe or ineffective drugs. Sen. Chuck Grassley, R-Iowa, told a Senate hearing last month he feared "that the FDA has a relationship with drug companies that is too cozy."

The survey results also lend credence to surprising congressional testimony last month by FDA scientist David Graham. The associate director of science and medicine in the FDA's drug safety office said the agency didn't adequately weigh safety concerns of drugs on the market and was incapable of preventing another Vioxx-type incident. The painkiller was pulled from the market Sept. 30 by maker Merck after a study tied it to increased risk of heart attack and stroke with long-term use.

The survey also found that:

•31% of the scientists were only "somewhat confident" and 5% were "not at all confident" that final decisions on new drugs adequately assessed the drug's safety; 52% were mostly confident; and 13% were completely confident.

•59% of them said the six months allotted to review some drugs wasn't enough time.

In a statement Thursday, the FDA said the study confirmed that, "overall," FDA medical reviewers believe their decisions appropriately assess drug safety and effectiveness and that debate is open and in-depth.

Still, the survey results "should cause a great deal of concern," says Arthur Levin of the Center for Medical Consumers, a New York-based patient advocacy group. But he says all fault doesn't lie with the FDA. Congress authorized it to collect fees from drugmakers to speed new drug approvals, blurring the line between those checking on drugs and those making them.

Grassley, a frequent FDA critic, said the survey helps "make an even stronger case" that a shake-up is needed at the FDA. That some scientists felt pressured, a survey statistic reported last year by consumer group Public Citizen, is noteworthy, says Jerry Avorn, author of Powerful Medicines and associate professor of medicine at Harvard Medical School. "Nearly one in five is a bad pattern," he says.

In contrast, HHS' report last year concluded that FDA scientists had "confidence" in FDA decisions. While noting that workload pressures may be harming the process, it said scientists did not believe they were ignoring key information or data in order to meet time goals. "We have no evidence of a public health concern nor did we seek to obtain such evidence," the report said.

Public Employees for Environmental Responsibility secured the survey and released it with the Union of Concerned Scientists.

Contributing: Donna Leinwand

U.S. Current Account Gap Widens

---

U.S. Current Account Gap Widens By Tim Ahmann WASHINGTON (Reuters) - The U.S. current account trade gap widened slightly to a record $164.71 billion in the third quarter, data showed on Thursday, but U.S. dependence on overseas capital was not as great as feared, fueling a big dollar rally. Reuters Photo Separate reports showed first-time claims for jobless aid posted their sharpest drop in three years last week, while activity at factories in the Middle Atlantic region quickened. But in a touch of bad news, the government said housing starts in November logged the biggest drop in nearly 11 years. Prices for U.S. government bonds slipped in the wake of the mixed data, but the dollar shot higher as traders breathed a collective sigh of relief that the trade shortfall was much smaller than the $170 billion Wall Street had braced for. Stock indices were close to flat in early afternoon as corporate news pulled in differing directions. The current account gap -- running at a hefty 5.6 percent of the size of the U.S. economy -- grew by just $318 million in the July-September period from a revised second-quarter reading of $164.39 billion, the Commerce Department (news - web sites) said. The second-quarter gap was first reported as $166.18 billion. The dollar has fallen roughly 5 percent against the euro this year and some 4 percent against a basket of major currencies amid worry that foreign investors' willingness to finance the huge trade deficit will fade. Economists have warned of the potential for a steep dollar drop if the supply of overseas cash that has helped fuel U.S. consumption begins to dry up. Stephen Cecchetti, former research director at the New York Federal Reserve (news - web sites) Bank, blamed bloated U.S. budget deficits for the troubling current account shortfall. "The problem with the current account is domestic saving," he said. "It requires a fiscal policy solution." British Chancellor of the Excheckr Gordon Brown said on Thursday the twin U.S. trade and budget deficits were causing global economic stress and that he would discuss the matter with U.S. officials in coming days. "They have got to set a clear path for showing that these can be dealt with over the next period of time," he said shortly before jetting off to New York. President Bush (news - web sites), who pushed big tax cuts through Congress during his first term, restated Washington's commitment to getting its fiscal house in order on Wednesday as he met with Italian Prime Minister Silvio Berlusconi. JOB MARKET BRIGHTENS, HOUSING SOURS A separate report showed initial claims for jobless benefits fell by much more than expected in the week ending Dec. 11 to 317,000, their lowest level since July. Wall Street economists had expected only a slight dip to 340,000. The Labor Department (news - web sites) said there were no special factors to account for the drop, the largest since December 2001, but cautioned claims are often volatile in the holiday period toward the end of the year. (Sam note: Jobless claims ALWAYS drop at this time of the holiday year! This is the same ol' manipulative propraganda by the Bush administration.) "It brings the claims number back down to a level that's really very positive," said Patrick Fearon, economist at A.G. Edwards & Sons in St. Louis. Separately, the Federal Reserve Bank of Philadelphia said its index of factory activity in the mid-Atlantic region jumped to 29.6 in December from 20.7 in November, well ahead of forecasts. It was the 19th straight month the index has indicated an expansion with a reading above zero. Another report showed housing starts unexpectedly plummeted 13.1 percent last month, the biggest dive since a 17 percent tumble in January 1994, as groundbreaking activity fell sharply across the nation. Housing starts slid to an annual rate of 1.771 million units in November from an upwardly revised 2.039 million clip a month earlier, the Commerce Department said. Economists had expected starts to ease only slightly and some saw the report as a sign of brewing trouble for the long high-flying U.S. housing sector. "The housing market is finally beginning to cool off. This is the beginning of the end," said David Wyss, chief economist for Standard & Poor's. "The housing number is scary." (Additional reporting by Alister Bull in Washington and Pedro Nicolaci da Costa in New York)

AP: Woman Died During Gov't AIDS Study

AP: Woman Died During Gov't AIDS Study

17 minutes ago

By JOHN SOLOMON and RANDY HERSCHAFT, Associated Press Writers

A pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS (news - web sites) died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say.

AP Photo AP Photo Slideshow: HIV/AIDS

Family members of Joyce Ann Hafford say the 33-year-old HIV (news - web sites)-positive woman died without ever holding her newborn boy. They also said they never were told the National Institutes of Health (news - web sites) concluded the drug therapy likely caused her death.

The family first learned of NIH's conclusions when The Associated Press obtained copies of the case file this month. For the past year, they say they were left to believe Hafford, of Memphis, Tenn., died from AIDS complications but began pursuing litigation to learn more.

"They tried to make it sound like she was just sick. They never connected it to the drug," said Rubbie King, Hafford's sister.

"If it were the disease, solely the disease, and the complications associated with the disease, that would be more readily acceptable than her being administered medication that came with warnings that the medical community failed to get ... to her."

Documents show Hafford's case reverberated among the government's top scientists in Washington, who were monitoring reports of her declining health in late July 2003 as she lay on a respirator.

NIH officials quickly suspected the drug regimen because it included nevirapine, a drug known to cause liver problems, and the case eventually reached the nation's chief AIDS researcher.

"Ouch! Not much wwe (we) can do about dumd (dumb) docs," Dr. Edmund Tramont, NIH's AIDS Division chief, responded in an e-mail after his staff reported that doctors continued to administer the drugs nevirapine and Combivir to Hafford despite signs of liver failure.

Nevirapine is an antiretroviral AIDS drug used since the mid-1990s, and the government has warned since at least 2000 that it could cause lethal liver problems or rashes when taken in multiple doses over time.

Asked about the case Thursday, White House press secretary Scott McClellan called Hafford's death "tragic and terrible." He gave no view on whether use of multiple doses of the drug should be halted.

"We want to see what the National Institute of Medicine (news - web sites) says," said McClellan. But he reiterated that the single dose of nevirapine used in the president's emergency AIDS relief plan in Africa is considered safe.

NIH officials acknowledge that experimental drugs, most likely nevirapine, caused Hafford's death, and that keeping the family in the dark was inappropriate. But NIH usually leaves disclosures like that to the doctors who treated her, officials said.

"We feel horrible that something like this would happen to anyone in any circumstance," said Dr. H. Clifford Lane, NIH's No. 2 infectious disease specialist. "There are risks in research and we try to minimize them."

Jim Kyle, a lawyer representing Regional Medical Center in Memphis where Hafford died, declined comment because of the family's pending litigation. The doctors there referred a call seeking comment to NIH.

The study during which Hafford died recently led researchers to conclude that nevirapine poses risks when taken over time by certain pregnant women.

"Continuous nevirapine may be associated with increased toxicity among HIV-1 infected pregnant women" with certain liver cell counts, the study concluded.

Lane said Hafford should have signed a 15-page, NIH-approved consent form at the start of the experiment specifically warning her of the risks of liver failure. The family says Hafford seemed unaware of the liver risks. They even kept the bottle of nevirapine showing it had no safety warnings.

"My daughter didn't know any of the warning signs," said Rubbie Malone, Hafford's mother and now caretaker of Hafford's new baby and older son. "She never got to hold her baby."

Lane confirmed the nevirapine bottle Hafford received likely wouldn't have had safety warnings because the experiment's rules called for the patient to be unaware of the exact drug effects to avoid patient influence on the test results. That means the consent form would have been her lone warning about potential liver problems, he said.

That 15-page, single-spaced consent form is chock full of complex medical terms like "hypersensitivity reactions" and "pharmacokinetic test." The warning about potential liver problems shows up on the sixth page, where it said liver inflammation was possible and "rarely may lead to severe and life threatening liver damage and death."

Hafford, who was HIV-positive but otherwise healthy, agreed to participate in the NIH-funded research project that provided her multiple doses of nevirapine, also known as Viramune, to protect her soon-to-be-born son, Sterling, from getting HIV at birth.

The project was an outgrowth of earlier research in Africa that concluded the drug could be taken in single doses safely to protect newborns half the time.

"She didn't want her baby to be born with HIV infection if it could be prevented at any cost," said King, her sister.

Hafford died Aug. 1, 2003, less than 72 hours after giving birth. Sterling was delivered prematurely by Caesarean section as his mother was dying. Though premature, he was spared from HIV and is healthy.

NIH's documents suggest Hafford's life might also have been spared if the drug had been stopped when the first liver problems showed up in her blood work two weeks before death.

"This case was particularly unfortunate b/c (because) the PI (principle investigative doctor) didn't stop drug when grade 3 liver enzymes were reported," Dr. Jonathan Fishbein, NIH's chief of good research practices, told Tramont in an August 2003 e-mail.

Fishbein, who is seeking federal whistleblower protection after raising concerns about NIH's practices, told AP that Hafford's death is attributable to a bigger problem in government research.

"This is not just a clinical trial issue this is a healthcare issue. The public expects that diagnostic test results are promptly evaluated and acted on, if need be," Fishbein said. "Sadly, this is but one example where an assessment was not done quickly and it cost this young mother her life."

NIH's official review determined the Memphis hospital failed to react to lab results that showed her liver failure was starting well before she died. "The site had identified that there was a delay in reviewing laboratory evaluations from the clinic visit the week before she presented with clinical hepatitis," an Aug. 15, 2003, report concluded.

The official investigative files cited "drug-induced hepatitis" of the liver as the cause of death.

As is routine after a research-related death, NIH ordered changes to the rules its researchers followed in the nevirapine studies to ensure the early detection of liver problems, the memos show.

___

On the Net:

Documents gathered by AP for this story are available at: http://wid.ap.org/documents/nevirapine3.html

National Institutes of Health: http://www.nih.gov

Fishbein's whistleblower Web site: http://www.honestdoctor.org/

THANKS, BUSH FOR "BRING IT ON!"

December 16, 2004 A Flood of Troubled Soldiers Is in the Offing, Experts Predict By SCOTT SHANE ASHINGTON, Dec. 15 - The nation's hard-pressed health care system for veterans is facing a potential deluge of tens of thousands of soldiers returning from Iraq with serious mental health problems brought on by the stress and carnage of war, veterans' advocates and military doctors say. An Army study shows that about one in six soldiers in Iraq report symptoms of major depression, serious anxiety or post-traumatic stress disorder, a proportion that some experts believe could eventually climb to one in three, the rate ultimately found in Vietnam veterans. Because about one million American troops have served so far in the conflicts in Iraq and Afghanistan, according to Pentagon figures, some experts predict that the number eventually requiring mental health treatment could exceed 100,000. "There's a train coming that's packed with people who are going to need help for the next 35 years," said Stephen L. Robinson, a 20-year Army veteran who is now the executive director of the National Gulf War Resource Center, an advocacy group. Mr. Robinson wrote a report in September on the psychological toll of the war for the Center for American Progress, a Washington research group. "I have a very strong sense that the mental health consequences are going to be the medical story of this war," said Dr. Stephen C. Joseph, who served as the assistant secretary of defense for health affairs from 1994 to 1997. What was planned as a short and decisive intervention in Iraq has become a grueling counterinsurgency that has put American troops into sustained close-quarters combat on a scale not seen since the Vietnam War. Psychiatrists say the kind of fighting seen in the recent retaking of Falluja - spooky urban settings with unlimited hiding places; the impossibility of telling Iraqi friend from Iraqi foe; the knowledge that every stretch of road may conceal an explosive device - is tailored to produce the adrenaline-gone-haywire reactions that leave lasting emotional scars. And in no recent conflict have so many soldiers faced such uncertainty about how long they will be deployed. Veterans say the repeated extensions of duty in Iraq are emotionally battering, even for the most stoical of warriors. Military and Department of Veterans Affairs officials say most military personnel will survive the war without serious mental issues and note that the one million troops include many who have not participated in ground combat, including sailors on ships. By comparison with troops in Vietnam, the officials said, soldiers in Iraq get far more mental health support and are likely to return to a more understanding public. But the duration and intensity of the war have doctors at veterans hospitals across the country worried about the coming caseload. "We're seeing an increasing number of guys with classic post-traumatic stress symptoms," said Dr. Evan Kanter, a psychiatrist at the Puget Sound veterans hospital in Seattle. "We're all anxiously waiting for a flood that we expect is coming. And I feel stretched right now." A September report by the Government Accountability Office found that officials at six of seven Veterans Affairs medical facilities surveyed said they "may not be able to meet" increased demand for treatment of post-traumatic stress disorder. Officers who served in Iraq say the unrelenting tension of the counterinsurgency will produce that demand. "In the urban terrain, the enemy is everywhere, across the street, in that window, up that alley," said Paul Rieckhoff, who served as a platoon leader with the Florida Army National Guard for 10 months, going on hundreds of combat patrols around Baghdad. "It's a fishbowl. You never feel safe. You never relax." In his platoon of 38 people, 8 were divorced while in Iraq or since they returned in February, Mr. Rieckhoff said. One man in his 120-person company killed himself after coming home. "Too many guys are drinking," said Mr. Rieckhoff, who started the group Operation Truth to support the troops. "A lot have a hard time finding a job. I think the system is vastly under-prepared for the flood of mental health problems." Capt. Tim Wilson, an Army chaplain serving outside Mosul, said he counseled 8 to 10 soldiers a week for combat stress. Captain Wilson said he was impressed with the resilience of his 700-strong battalion but added that fierce battles have produced turbulent emotions. "There are usually two things they are dealing with," said Captain Wilson, a Southern Baptist from South Carolina. "Either being shot at and not wanting to get shot at again, or after shooting someone, asking, 'Did I commit murder?' or 'Is God going to forgive me?' or 'How am I going to be when I get home?' " When all goes as it should, the life-saving medical services available to combat units like Captain Wilson's may actually swell the ranks of psychological casualties. Of wounded soldiers who are alive when medics arrive, 98 percent now survive, said Dr. Michael E. Kilpatrick, the Pentagon's deputy director of deployment health support. But they must come to terms not only with emotional scars but the literal scars of amputated limbs and disfiguring injuries. Through the end of September, the Army had evacuated 885 troops from Iraq for psychiatric reasons, including some who had threatened or tried suicide. But those are only the most extreme cases. Often, the symptoms of post-traumatic stress disorder do not emerge until months after discharge. "During the war, they don't have the leisure to focus on how they're feeling," said Sonja Batten, a psychologist at the Baltimore veterans hospital. "It's when they get back and find that their relationships are suffering and they can't hold down a job that they realize they have a problem." Robert E. Brown was proud to be in the first wave of Marines invading Iraq last year. But Mr. Brown has also found himself in the first ranks of returning soldiers to be unhinged by what they experienced. He served for six months as a Marine chaplain's assistant, counseling wounded soldiers, organizing makeshift memorial services and filling in on raids. He knew he was in trouble by the time he was on a ship home, when the sound of a hatch slamming would send him diving to the floor. After he came home, he began drinking heavily and saw his marriage fall apart, Mr. Brown said. He was discharged and returned to his hometown, Peru, Ind., where he slept for two weeks in his Ford Explorer, surrounded by mementos of the war. "I just couldn't stand to be with anybody," said Mr. Brown, 35, sitting at his father's kitchen table. Dr. Batten started him on the road to recovery by giving his torment a name, an explanation and a treatment plan. But 18 months after leaving Iraq, he takes medication for depression and anxiety and returns in dreams to the horrors of his war nearly every night. The scenes repeat in ghastly alternation, he says: the Iraqi girl, 3 or 4 years old, her skull torn open by a stray round; the Kuwaiti man imprisoned for 13 years by Saddam Hussein, cowering in madness and covered in waste; the young American soldier, desperate to escape the fighting, who sat in the latrine and fired his M-16 through his arm; the Iraqi missile speeding in as troops scramble in the dark for cover. "That's the one that just stops my heart," said Mr. Brown. "I'm in my rack sleeping and there's a school bus full of explosives coming down at me and there's nowhere to go." Such costs of war, personal and financial, are not revealed by official casualty counts. "People see the figure of 1,200 dead," said Dr. Kanter, of Seattle, referring to the number of Americans killed in Iraq. "Much more rarely do they see the number of seriously wounded. And almost never do they hear anything at all about the psychiatric casualties." As of Wednesday 5,229 Americans have been seriously wounded in Iraq. Through July, nearly 31,000 veterans of Operation Iraqi Freedom had applied for disability benefits for injuries or psychological ailments, according to the Department Veterans Affairs. Every war produces its medical signature, said Dr. Kenneth Craig Hyams, a former Navy physician now at the Department of Veterans Affairs. Soldiers came back from the Civil War with "irritable heart." In World War I there was "shell shock." World War II vets had "battle fatigue." The troubles of Vietnam veterans led to the codification of post-traumatic stress disorder. In combat, the fight-or-flight reflex floods the body with adrenaline, permitting impressive feats of speed and endurance. But after spending weeks or months in this altered state, some soldiers cannot adjust to a peaceful setting. Like Mr. Brown, for whom a visit to a crowded bank at lunch became an ordeal, they display what doctors call "hypervigilance." They sit in restaurants with their backs to a wall; a car's backfire can transport them back to Baghdad. To prevent such damage, the Army has deployed "combat stress control units" in Iraq to provide treatment quickly to soldiers suffering from emotional overload, keeping them close to the healing camaraderie of their unit. "We've found through long experience that this is best treated with sleep, rest, food, showers and a clean uniform, if that is possible," said Dr. Thomas J. Burke, an Army psychiatrist who oversees mental health policy at the Department of Defense. "If they get counseling to tell them they are not crazy, they will often get better rapidly." To detect signs of trouble, the Department of Defense gives soldiers pre-deployment and post-deployment health questionnaires. Seven of 17 questions to soldiers leaving Iraq seek signs of depression, anxiety and post-traumatic stress disorder. But some reports suggest that such well-intentioned policies falter in the field. During his time as a platoon leader in Iraq, Mr. Rieckhoff said, he never saw a combat stress control unit. "I never heard of them until I came back," he said. And the health screens have run up against an old enemy of military medicine: soldiers who cover up their symptoms. In July 2003, as Jeffrey Lucey, a Marine reservist from Belchertown, Mass., prepared to leave Iraq after six months as a truck driver, he at first intended to report traumatic memories of seeing corpses, his parents, Kevin and Joyce Lucey, said. But when a supervisor suggested that such candor might delay his return home, Mr. Lucey played down his problems. At home, he spiraled downhill, haunted by what he had seen and began to have delusions about having killed unarmed Iraqis. In June, at 23, he hanged himself with a hose in the basement of the family home. "Other marines have verified to us that it is a subtle understanding which exists that if you want to go home you do not report any problems," Mr. Lucey's parents wrote in an e-mail message. "Jeff's perception, which is shared by others, is that to seek help is to admit that you are weak." Dr. Kilpatrick, of the Pentagon, acknowledges the problem, saying that National Guardsmen and Reservists in particular have shown an "abysmal" level of candor in the screenings. "We still have a long ways to go," he said. "The warrior ethos is that there are no imperfections." Richard A. Oppel Jr. contributed reporting from Baghdad for this article.