MBVP NEWS

Special To Local Tech Wire

RESEARCH TRIANGLE PARK, N.C. – The Food and Drug Administration has given RTP-based Chimerix approval to conduct a clinical trial for its proposed treatment of smallpox and complications resulting from smallpox vaccine.


Chimerix is a developer of antiviral therapeutics that are delivered orally.

The company plans to begin a Phase I clinical trial of healthy volunteers now that the FDA has given its OK to a new drug application for the drug called CMX001.

“Smallpox is a devastating bioterrorism threat and vaccination is not an option for more than 40 million Americans with compromised immune systems," said George Painter, Chimerix president and chief executive officer. “Using our platform technology, we have developed CMX001, an orally available drug candidate. We expect CMX001 to have utility not only for the treatment of smallpox infections in people but also as a treatment for the adverse side effects associated with smallpox vaccination."

Smallpox, anthrax and the botulism toxin are considered among the most feared bioweapons that could be developed by terrorists.

Chimerix is developing CMX001 through a $36.1 million grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. The grant was awarded in 2003. The company also received $11 million in venture funding in 2004.

CMX001 has already been used to treat orthopox virus infections – a viral class that includes smallpox – in animal models, the company said.

Smallpox, once one of the most feared killers of mankind, was eradicated as a disease in 1979. It was stopped through a global vaccination program.

Smallpox is transmitted from person to person by infected aerosols and air droplets spread in face-to-face contact with an infected person after fever has begun, especially if symptoms include coughing, according to the World Health Organization’s website. The disease can also be transmitted by contaminated clothes and bedding, though the risk of infection from this source is much lower, according to the WHO.

Chimerix was launched in 2002. It utilizes proprietary drug development technology developed at the University of California at San Diego and the Veterans Administration Hospital in San Diego, CA.

Painter, a former executive with Triangle Pharmaceuticals and Glaxo Wellcome, was among the early pioneers in efforts to develop drugs to combat HIV. Triangle developed the drug Coviracil before being acuqired by Gilead Sciences in 2003.

Posted by MBVIC at 8:46 PM | Permalink

Paulo J. Reyes

FOR IMMEDIATE RELEASE

Contact: Diana - diana@pauloreyes.com
954) 971-4025
http://www.pauloreyes.com

Los Angeles, California, June 2006. In late September, Health and Human Services Secretary Michael Leavitt told members of Congress in a classified closed-door meeting that bird flu could conceivably kill hundreds of thousands of Americans. Within 24 hours, a $3.9 billion legislative proposal to buy and stockpile huge new quantities of vaccines and antiviral medications was designed and passed with almost no debate or discussion.

Mike Osterholm wrote in a July 2005 issue of Foreign Affairs, “If an influenza pandemic struck today, borders would close, the global economy would shut down, international vaccine supplies and health-care systems would be overwhelmed, and panic would reign. To limit the fallout, the industrialized world must create a detailed response strategy involving the public and private sectors.”

Pandemic viruses aren’t the only threat facing our nation. Drug-resistant bacteria and terrorist attacks spreading anthrax, smallpox or other deadly substances are also concerns in Washington.

Dr. Paulo J. Reyes, an ER Doctor and first responder in California is the author of a book on bioterrorism, Sledgehammer. He strives to increase the awareness of this potential threat now. Reyes’ book, Sledgehammer, (ISBN #097713870-4) a fiction thriller, details an outbreak of smallpox and its devastating and fatal effects. Based on factual information and real life hospital settings, it portrays a terrorist attack utilizing smallpox and the struggles the medical profession must endure to get government acceptance that this deadly disease is once again a clear and present danger. The plot is well written and has received numerous 5 star reviews. You grow fond of the characters and long for a cure in time to save the hospital staff and the nation.

To learn more about Sledgehammer go to Dr. Reyes website at http://www.pauloreyes.com. His book, Sledgehammer is also available through the publisher at http://www.virtualwordpublishing.com, Amazon, Barnes & Noble and other leading bookstores.

Posted by MBVIC at 8:29 PM | Permalink

Global Security Newswire

The U.S. Homeland Security Department is today scheduled to break ground for its controversial National Biodefense Analysis and Countermeasures Center at Fort Detrick, Md., the Associated Press reported (see GSN, Aug. 24, 2005).


The $128 million, 160,000-square-foot laboratory is to be the first agency site working solely on biodefense upon opening in 2008. It is expected to study biological threat vulnerabilities and consequences, and to conduct forensic analysis of evidence, according to AP.

The center will incorporate the National Bioforensic Analysis Center and the Biological Threat Characterization Center, which are already operating at other locations. The Agricultural Biodefense Center at the Plum Island Animal Disease Center in New York and the Biodefense Knowledge Center at the Lawrence Livermore National Laboratory in California are considered part of the center, but would not be incorporated into the new facility.

Critics have expressed concern that the center's work could be considered biological weapons research.

There is little difference beyond intent between offensive and defensive research, said Michael Stebbins, director of the Federation of American Scientists' Biosecurity Project.

Jason Kray, a member of a local activist group, also criticized the facility.

"I do not trust the Army to operate (NBACC) in a safe, ethical or legal manner," he said (Associated Press/WTOP Radio, June 26).

NBACC scientific director Bernard Courtney said biologists at the center would create pathogens to match strains that terrorists are producing and then prepare countermeasures, the Baltimore Sun reported today.

He added, however, that the center is prepared to engineer a modified disease organism only once there is credible evidence that terrorists are pursuing it.

Some arms control experts have expressed concern that such efforts could lead to development of new vaccine-resistant pathogens.

Scientists could end up "in essence creating new threats that we're going to have to defend ourselves against," said Alan Pearson, director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Nonproliferation (Douglas Birch, Baltimore Sun, June 26).

Posted by MBVIC at 9:16 PM | Permalink

Global Security Newswire

The United States has spent or distributed more than $36 billion for biodefense since 2001, an amount expected to increase to $44 billion in fiscal 2007, the Center for Arms Control and Nonproliferation said in an analysis released last week (see GSN, Feb. 7).


The Bush administration is proposing in the next fiscal year to spend $8 billion for defenses against biological weapon, a hike of $120 million from spending approved by Congress for fiscal 2006 (Center for Arms Control and Non-Proliferation analysis).

The majority of funding — more than $26 billion through fiscal 2007 — has been directed toward development of countermeasures against pathogens and protective gear. Another $3 billion has probably been aimed at upgrading medical monitoring and environmental detection of weaponized agents, with $7.5 billion designated for preparing state and local agencies and hospitals for an attack.

“Only 2 percent of all federal bioweapons-related funding has been devoted to efforts to prevent the development, acquisition, and use of biological weapons by states and terrorists and other nonstate actors” the center said in a press release. “Stronger prevention efforts, including a commitment to broad cooperative international action, are essential for improving our nation’s security” (Center for Arms Control and Nonproliferation release, June 21).

The U.S. Health and Human Services Department is set to receive 82 percent of federal biodefense funds in fiscal 2007, according to an article by researchers at the University of Pittsburgh Center for Biosecurity.

The budget request for civilian biodefense efforts is $5.24 billion, $112 million more than the fiscal 2006 request. Homeland Security is set to receive $180 million less it did in this fiscal year, a 31-percent decrease due to a one-time emergency allocation it received following Hurricane Katrina (University of Pittsburgh Center for Biosecurity release, June 20).

Posted by MBVIC at 9:06 PM | Permalink

Global Security Newswire

A U.S. scientist yesterday expressed doubts about a Palestinian militant group’s claim to have produced biological and chemical weapons (see GSN, June 26).


The al-Aqsa Martyrs’ Brigades distributed a leaflet on the Gaza Strip claiming in the last three years to have developed 20 biological and chemical weapons. It threatened to use the weapons following any Israeli military incursion into the Gaza Strip.

“It is impossible to manufacture that many chemical and biological weapons in three years without an army of scientists and laboratories,” said Michael Stebbins, director of the Biosecurity Project at the Federation of American Scientists. “They would need a very sophisticated program with very skilled workers.”

Such an effort would have been “easily identifiable” Stebbins added.

However, certain toxins could be “made by almost everyone” he said. Ricin — which is two times as deadly as cobra venom — could be produced from materials found in the kitchen, Stebbins said (see GSN, June 2).

Stebbins said the group could be working with “some failed academic scientists.”

“It is possible, though not probable, that Aqsa may have managed to acquire certain chemicals,” he said.

The threat is being taken seriously in Israel, the Sun reported.

“This is a dangerous development in the region and Israel must take the right measures,” said David Saranga, the consul for public affairs at the Israeli Consulate General in New York (Shalin Punn, The New York Sun, June 27).

Posted by MBVIC at 9:05 PM | Permalink

The New York Times
By GARDINER HARRIS

WASHINGTON, June 26 - A 15-month inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.


For instance, the investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Representative Henry A. Waxman of California, the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the F.D.A. continued to uncover about the same number of problems at drug and device companies as before, Mr. Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations.

The biggest decline in enforcement actions was found at the agency's device center, where they decreased 65 percent in the five-year period despite a wave of problems with devices including implantable defibrillators and pacemakers.

"Americans have relied on F.D.A. to ensure the safety of their food and drugs for 100 years," Mr. Waxman said. "But under the Bush administration, enforcement efforts have plummeted and serious violations are ignored."

David K. Elder, the director of the agency's Office of Enforcement, explained that the F.D.A. had increasingly focused on the most serious violations.

"As a result of F.D.A.'s focus on those firms and those violations that present the highest risk to consumers and public health," Mr. Elder said in a statement, "the agency has taken prompt, targeted and aggressive action against firms that are in violation of law."

Jack Calfee, a resident scholar at the conservative American Enterprise Institute, said the decline in the statistics was meaningless because most of the violations involved paperwork problems.

"I doubt that it makes a significant difference in the safety of drugs or other products," Mr. Calfee said.

Mr. Waxman began his inquiry after Congressional hearings in 2004 suggested that the agency was partly to blame for a shortage of flu vaccines. His staff requested thousands of documents from the F.D.A.

The investigation found that by almost every measure, enforcement actions had significantly declined from 2000 to 2005. The lone exception was in the number of products that had to be recalled from the market: that increased 44 percent.

"Since one of the goals of an enforcement system is to deter violations and keep dangerous products off of the market," the report said, "the increase in recalls is not a hallmark of effective enforcement."

In one prominent case, in December 2000, a worker at a nursing home in Xenia, Ohio, mistakenly hooked up a tank of nitrogen gas to the home's oxygen delivery system. Four residents died.

In the months that followed, investigators for the agency concluded that the company that delivered the tanks, BOC Gases, was partly to blame for the mix-up, given what they deemed inadequacy of the company's own controls and employee training. Indeed, BOC had a "corporate-wide problem," F.D.A. documents at the time said. The investigators recommended prosecution, but the agency took no enforcement action.

Kristina Schurr, a spokeswoman for BOC, said that the company's controls had not been to blame but that in any case it had improved its procedures since then.

Several former top officials of the agency attributed the decline in enforcement actions to budget problems.

"This is a tragedy," said Peter Barton Hutt, a former general counsel of the F.D.A. who now represents drug companies and teaches food and drug law at Harvard . "Congress has failed to realize that our single most important government agency is being systematically dismantled."

Dr. Sidney M. Wolfe, director of the Health Research Group at the watchdog organization Public Citizen, noted that the agency now received about $380 million a year in fees from drug makers.

"The public," Dr. Wolfe said, "is getting the kind of F.D.A . that the industry is paying for them to get."

Posted by MBVIC at 8:59 PM | Permalink

Global Security Newswire

The Virginia National Guard plans to develop a task force to support the response to a potential attack involving an unconventional weapon, officials said Friday (see GSN, April 18).


Guard units around the nation are preparing to work with state and local agencies in the event of a chemical, biological, radiological or nuclear attack, the Washington Post reported.

“The idea is to help in any kind of weapons-of-mass-destruction kind of attack,” said Jack Harrison, a National Guard spokesman.

About 500 soldiers and airmen with experience in medical triage, chemical decontamination, explosive detection and other areas would put in 18 months of training for the task force, said Lt. Col. Chester Carter III, a spokesman for the Virginia National Guard.

“We would support the first responder,” he said. “What we would do is bring to the table an additional tool in such an event.”

The U.S. Defense Department developed the nationwide program, the Post reported. The National Guard selected 17 states for the task force program. Harrison said personnel in 12 states have gone through the training and are “mission-ready” (Sandhya Somashekhar, Washington Post, June 24).

Posted by MBVIC at 9:12 PM | Permalink

CIDRAP News

A panel of military physician experts found that a combination of smallpox and injectable influenza vaccines might have caused the death of a 26-year-old Army soldier, the Department of Defense (DoD) announced last week.


The soldier, Pfc. Christopher "Justin" Abston, died suddenly in his barracks room, 16 days after he received the vaccines on Nov 18, 2005, at Fort Bragg, N.C, DoD said in a Jun 22 news release.

At autopsy, Abston was found to have myocarditis, an inflammation of the heart muscle. Myocarditis is known to be a potential side effect of smallpox vaccination. After evaluating the results of several specialized tests, the medical panel determined that a relationship between the vaccines and the soldier's death was "possible."

Test results ruled out the presence of the vaccinia virus, the main ingredient of smallpox vaccine, in Abston's heart muscle. However, parvovirus B19 was found, which can also cause cardiac inflammation and death. The medical panel stated that a link between the vaccinations and the death was "neither probable nor unlikely," but the findings "do suggest the possibility that the vaccines may have caused Abston's death."

According to a safety summary posted on the DoD's Smallpox Vaccination Program Web site, of 1,028,000 military and support personnel who have received the smallpox vaccination since December 2002, 120 subsequently had myopericarditis.

The DoD has investigated eight deaths due to disease after smallpox vaccination. Medical panels found that one other death besides Abston's may have been related to vaccination. In that case, Spc. Rachel Lacy of the Army Reserve died in 2003 from a severe inflammatory process consistent with systemic lupus erythematosus (SLE) about a month after receiving a combination of vaccines that included smallpox, anthrax, typhoid, hepatitis B, and measles-mumps-rubella. (See link to November 2003 CIDRAP News story below). The DoD noted that while Lacy's death certificate lists "diffuse alveolar damage" and pericarditis, the pericarditis developed late in her illness.

Posted by MBVIC at 10:59 AM | Permalink

By Joby Warrick
Washington Post Staff Writer

In late January 2003, as Secretary of State Colin Powell prepared to argue the Bush administration's case against Iraq at the United Nations, veteran CIA officer Tyler Drumheller sat down with a classified draft of Powell's speech to look for errors. He found a whopper: a claim about mobile biological labs built by Iraq for germ warfare.


Drumheller instantly recognized the source, an Iraqi defector suspected of being mentally unstable and a liar. The CIA officer took his pen, he recounted in an interview, and crossed out the whole paragraph.

A few days later, the lines were back in the speech. Powell stood before the U.N. Security Council on Feb. 5 and said: "We have first-hand descriptions of biological weapons factories on wheels and on rails."

The sentence took Drumheller completely by surprise.

"We thought we had taken care of the problem," said the man who was the CIA's European operations chief before retiring last year, "but I turn on the television and there it was, again."

While the administration has repeatedly acknowledged intelligence failures over Iraqi weapons claims that led to war, new accounts by former insiders such as Drumheller shed light on one of the most spectacular failures of all: How U.S. intelligence agencies were eagerly drawn in by reports about a troubled defector's claims of secret germ factories in the Iraqi desert. The mobile labs were never found.

Drumheller, who is writing a book about his experiences, described in extensive interviews repeated attempts to alert top CIA officials to problems with the defector, code-named Curveball, in the days before the Powell speech. Other warnings came prior to President Bush's State of the Union address on Jan. 28, 2003. In the same speech that contained the now famous "16 words" on Iraqi attempts to acquire uranium, Bush spoke in far greater detail about mobile labs "designed to produce germ warfare agents."

The warnings triggered debates within the CIA but ultimately made no visible impact at the top, current and former intelligence officials said. In briefing Powell before his U.N. speech, George Tenet, then the CIA director, personally vouched for the accuracy of the mobile-lab claim, according to participants in the briefing. Tenet now says he did not learn of the problems with Curveball until much later and that he received no warnings from Drumheller or anyone else.

"No one mentioned Drumheller, or Curveball," Lawrence B. Wilkerson, Powell's chief of staff at the time, said in an interview. "I didn't know the name Curveball until months afterward."

Curveball's role in shaping U.S. declarations about Iraqi bioweapons capabilities was first described in a series of reports in the Los Angeles Times, and later in a March 2005 report by a presidential commission on U.S. intelligence failures regarding allegations that Iraq possessed weapons of mass destruction. But Drumheller's first-hand accounts add new detail about the CIA's embrace of a source whose credibility was already unraveling.

More than a year after Powell's speech, after an investigation that extended to three continents, the CIA acknowledged that Curveball was a con artist who drove a taxi in Iraq and spun his engineering knowledge into a fantastic but plausible tale about secret bioweapons factories on wheels.

But in the fall of 2002, Curveball was living the life of an important spy. A Baghdad native whose real name has never been released, he was residing in a safe house in Germany, where he had requested asylum three years earlier. In return for immigration permits for himself and his family, the Iraqi supplied Germany's foreign intelligence service with what appeared to be a rare insider's account of one of President Saddam Hussein's long-rumored WMD programs.

Curveball described himself as a chemical engineer who had worked inside an unusual kind of laboratory, one that was built on a trailer bed and produced weapons for germ warfare. He furnished detailed, technically complex descriptions of mobile labs and even described an industrial accident that he said killed a dozen people.

The German intelligence agency BND faithfully passed Curveball's stories to the Americans. Over time, the informant generated more than 100 intelligence reports on secret Iraqi weapons programs -- the only such reports from an informant claiming to have visited and worked in mobile labs. Other informants, also later discredited, had claimed indirect knowledge of mobile labs.

In late 2002, the Bush administration began scouring intelligence files for reports of Iraqi weapons threats. Drumheller was asked to press a counterpart from a European intelligence agency for direct access to Curveball. Other officials confirmed that it was the German intelligence service.

The German official declined but then offered a startlingly candid assessment, Drumheller recalled. "He said, 'I think the guy is a fabricator,' " Drumheller said, recounting the conversation with the official, whom he declined to name. "He said: 'We also think he has psychological problems. We could never validate his reports.' "

When Drumheller relayed the warning to his superiors in October 2002, it sparked what he described as "a series of the most contentious meetings I've ever seen" in three decades of government work.

Although no American had ever interviewed Curveball, analysts with the CIA's Center for Weapons Intelligence, Nonproliferation and Arms Control believed the informant's technical descriptions were too detailed to be fabrications.

"People were cursing. These guys were absolutely, violently committed to it," Drumheller said. "They would say to us, 'You're not scientists, you don't understand.' "

In January 2003, Drumheller received a new request from CIA headquarters to contact the German intelligence service about Curveball. This time, Drumheller recalled, the U.S. spy agency had three questions:

Could a U.S. official refer to Curveball's mobile lab accounts in an upcoming political speech?

Could the Germans guarantee that Curveball would stand by his account?

Could German intelligence verify Curveball's claims?

The reply from Berlin, as Drumheller recalls it, was less than encouraging: There are no guarantees.

"They said, 'We have never been able to verify his claims,' " Drumheller recalled. "And that was all sent up to Tenet's office."

When Drumheller listened to Bush's speech several days later, he was astonished to hear the mobile labs described in detail.

"Boom, there it was," he said.

A few days later, Drumheller was handed a draft of another key speech on Iraq: Powell's remarks to the U.N. Security Council accusing Hussein of reconstituting his WMD programs. This time, the speech included an obvious reference to Curveball -- an unnamed "chemical engineer" who worked in one of the labs -- as well as detailed drawings of mobile labs inspired by Curveball's descriptions.

Drumheller said he called the office of John E. McLaughlin, then the CIA deputy director, and was told to come there immediately. Drumheller said he sat across from McLaughlin and an aide in a small conference room and spelled out his concerns.

McLaughlin responded with alarm and said Curveball was "the only tangible source" for the mobile lab story, Drumheller recalled, adding that the deputy director promised to quickly investigate.

Portions of Drumheller's account of his meetings with McLaughlin and Tenet appear in the final report of the Silberman-Robb commission, which was appointed by Bush to investigate prewar U.S. intelligence failures on Iraq's weapons programs. The report cites e-mails and interviews with other CIA officials who were aware of the meetings.

In responding to questions about Drumheller, McLaughlin provided The Post with a copy of the statement he gave in response to the commission's report. The statement said he had no memories of the meeting with Drumheller and had no written documentation that the meeting took place.

"If someone had made these doubts clear to me, I would not have permitted the reporting to be used in Secretary Powell's speech," McLaughlin said in the statement.

In their briefings to Powell on Feb. 4, one day before the secretary's U.N. speech, Tenet and McLaughlin expressed nothing but confidence in the mobile-lab story, according to Wilkerson, Powell's chief of staff, who was present during the briefings.

"Powell and I were both suspicious because there were no pictures of the mobile labs," Wilkerson said. The drawings were constructed from Curveball's accounts.

But the CIA officials were persuasive. Wilkerson said the two men described the evidence on the mobile labs as exceptionally strong, based on multiple sources whose stories were independently corroborated.

"They said: 'This is it, Mr. Secretary. You can't doubt this one,' " Wilkerson said.

On the eve of the U.N. speech, Drumheller received a late-night phone call from Tenet, who said he was checking final details of the speech. Drumheller said he brought up the mobile labs.

"I said: 'Hey, boss, you're not going to use that stuff in the speech . . . ? There are real problems with that,' " Drumheller said, recalling the conversation.

Drumheller recalled that Tenet seemed distracted and tired and told him not to worry.

The following day, Tenet was seated directly behind Powell at the U.N. Security Council as the secretary of state presented a detailed lecture and slide show about an Iraqi mobile biological weapons program.

Tenet, responding to questions about Drumheller's accounts, provided to The Post a statement he had given in response to the Silberman-Robb Commission report in which he said he didn't learn of the problems with Curveball until much later. He did not recall talking to Drumheller about Curveball, and said it was "simply wrong" for anyone to imply that he knew about the problems with Curveball's credibility.

"Nobody came forward to say there is a serious problem with Curveball or that we have been told by the foreign representative of the service handling him that there are worries that he is a 'fabricator,' " Tenet said in his statement.

In late summer 2003, seven months after the U.N. speech, Tenet called Powell to say that the Curveball story had fallen apart, Wilkerson said. The call amounted to an admission that all of the CIA's claims Powell used in his speech about Iraqi weapons were wrong.

"They had hung on for a long time, but finally Tenet called Powell to say, 'We don't have that one, either,' " Wilkerson recalled. "The mobile labs were the last thing to go."

Staff researcher Alice Crites contributed to this report.

Posted by MBVIC at 11:53 AM | Permalink

New York Times
ELIZABETH OLSON

Emergent BioSolutions sells only one product, an anthrax vaccine called BioThrax, to only one customer, the federal government. So when it went looking for someone to fill a board seat, it had some very specific qualifications in mind.


Dr. Louis W. Sullivan meets them all. A physician who is president emeritus of the Morehouse School of Medicine in Atlanta, he serves on the boards of similar companies.

He also ran the Department of Health and Human Services from 1989 to 1993. That agency and the Department of Defense buy all of Emergent's vaccines. At least for now.

To expand, the company is trying to sign up states and cities, said Kyle W. Keese, its senior vice president for marketing. That is where another director, Jerome M. Hauer, comes in handy. He ran New York City's Office of Emergency Management under former Mayor Rudolph W. Giuliani.

Posted by MBVIC at 11:44 AM | Permalink

Evelyn Pringle

Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement. On June 20, 2006, the New York Times reported that “two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States.”


The Senators behind the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the committee.

“In broad terms,” the Times article by Gardner Harris explains, “the bill would require that drug makers disclose the results of all large human tests of their drugs, known as Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover and control any safety problems that arise after a drug is approved; and pay penalties if they fail to follow through with this plan, according to four experts who were briefed on the proposals.”

However, while lawmakers search for ways to ensure that Big Pharma does not continue to conceal adverse reactions that surface during drug trials and to sever the ties between the nation’s public health officials and Big Pharma, the Bush administration continues to promote their cozy relationships and help drug companies escape accountability for misconduct.

The best example of the administration's efforts to protect Big Pharma was revealed recently when the FDA announced a preemption rule that would disallow lawsuits in state court against drug makers if a drug has been approved by the FDA.

"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said FDA deputy commissioner on medical and scientific affairs, Scott Gottlieb.

But in all fairness, the FDA is certainly not the only public health agency in bed with Big Pharma. Nobody can deny the fact that Big Pharma is an equal opportunity corrupter. Its obvious that drug companies have infiltrated every Federal regulatory agency in the US.

For instance, on June 14, 2006, a National Institute of Health Alzheimer's researcher, Dr Trey Sunderland, asserted his Fifth Amendment rights, and refused to testify before the House Energy and Commerce Committee about accusations that he has profited from giving Pfizer access to spinal fluid and plasma samples collected by the NIH.

Documents presented at the hearing revealed that between 1996 an 2004, Dr Sunderland accepted consulting, speaking and advisory fees totaling about $612,000 and committee staff members estimate that about $285,000, was related to 3,245 samples taken from 538 patients who participated as volunteers at the NIH.

At a price of about $12,000 per patient, the committee estimates the cost of collecting the samples that Dr Sunderland handed to Pfizer is close to $6.5 million.

The committee also noted that he did not seek prior approval to work for Pfizer, and did not report any of the income to the agency as required by NIH rules.

In fact, at one point, when asked, Dr Sunderland said he had no outside deals. According to the December 22, 2004 LA Times, while reviewing financial disclosure reports from scientists at the NIH, in March 2000, ethics officer Olga Boikess noticed that Dr Sunderland had not declared any jobs with the industry so she sent him an e-mail that said: "You did not list any outside positions."

To which, Dr Sunderland replied: "I do not have any outside positions to note."

This case had been dragging on for years but the doctor has probably not been too worried because history shows that any time a Republican lawmaker get too pesky about the money trails leading to the NIH, Big Pharma simply offers enough money to induce him to jump ship.

A couple years ago, two Republicans on powerful committees switched sides shortly after they launched investigations into conflicts of interest between drug companies and employees at the NIH.

Representative, WJ "Billy" Tauzin (R-La), was chairman of the House Energy and Commerce Committee, and had cited "secret consulting fees and stock options
from drug companies" as reasons to request documentation of all payments from Big Pharma to NIH scientists.

But next thing you know, Tauzin announces that he is not running for reelection, and leaves Congress to become President of the Pharmaceutical Research and Manufacturers of America, the giant trade group that represents Big Pharma, with a reported $2 million a year in salary, benefits and perks.

Next up to bat, was Representative James Greenwood (R-Pa), who led 3 hearings on NIH conflicts of interest and criticized the agency for allowing scientists to use "a swivel chair" to make decisions while taking drug company money.

But low and behold, shortly thereafter, in July 2004, Rep Greenwood announced that he was giving up his post as chairman of the Energy and Commerce subcommittee to retire, only to become President of the Biotechnology Industry Organization, a group that in the same year, urged lawmakers not to bar NIH scientists from entering into paid consulting deals.

A report by the Office of Government Ethics, released the same month that Rep Greenwood announced his "retirement," said the NIH was beset by a "permissive culture," and revealed that 40% of the 155 randomly selected sample payments to agency employees reviewed had not been approved or accounted for within the NIH.

The FDA remains at the top of the list for corruption simply because the FDA evaluates the safety and effectiveness of drugs and decides which drugs can be marketed in the US.

Typically, as a first step toward the approval process, a drug company will initiate laboratory testing to assess the effectiveness and safety of a drug and if the laboratory testing is successful, the company will begin testing the drug on animals. The FDA does not become involved until the drug maker seeks permission to test the drug on humans.

When the drug reaches that point, the FDA's Center for Drug Evaluation and Research, evaluates the results of laboratory and animal testing prior to allowing any study on humans.

Once a drug is approved for testing on humans an Institutional Review Board (IRB) is appointed to review and monitor the research. An IRB is generally made up of outside scientists, doctors and other medical professionals and has the authority to approve or disapprove a study or to require modifications to secure approval of the research.

The purpose of an IRB is to assure that appropriate steps are taken to protect the rights and welfare of human subjects. To that end, an IRB uses a group process to review research protocols and materials such as informed consent documents and investigator brochures related to the research.

In recent years, serious questions have been raised regarding the impartiality of the review process due to the fact that many of the FDA advisors recommending approval of a product are at the same time employed by the drug company that developed the drug or hold some other financial interest link to the company.

Due to these conflicts of interests, critics say dangerous drugs are winning approval. For instance, nearly a third of the members of the advisory panel that reviewed the data on Vioxx, Celebrex and Bextra, and voted to allow the drugs to remain on the market, even after Vioxx had been pulled off the market, had financial ties to the makers of the drugs and had their votes not been counted, they would never have received a vote of approval.

In addition, problems continue to surface in the private research industry. Contract Research Organizations (CRO), are now hired by the industry to perform research.

Critics says the competing CROs are skewing research in favor of approval in order to win more contracts. The funding up for grabs is enormous. According to a March 24, 2006, MSNBC commentary by Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, "Private companies running studies for pharmaceutical and device companies are now a $14 billion industry in the United States alone."

According to John Abramson, a clinical instructor at Harvard Medical School, and author of, “Overdosed America“, “When the institutional review boards were created, most medical research was conducted by universities and nonprofit institutions.”

“Similarly,” Mr Abramson says, “oversight of the safety of human volunteers in most U.S. studies is no longer done by nonprofit IRBs, but by for-profit review companies, hired directly by the for-profit research companies.”

In his opinion, he says the system lacks the appropriate checks and balances to protect human volunteers.

In the April 6, 2006 LA Times, Mr Abramson made a shocking revelation when he said, “the FDA recently approved "phase 0 studies" in which human beings can be given minuscule doses of experimental drugs even before animal studies are completed.”

A recent case in the UK demonstrates the dangers that could occur in such a study. In March 2006, six otherwise healthy men ended up in a London hospital in critical condition after participating in the trial of a new an anti-inflammatory drug, called TGN1412, to treat conditions involving the immune system, such as leukemia, multiple sclerosis and rheumatoid arthritis, conducted by the US based company, Parexel International Corp, on behalf of the German drug maker TeGenero.

The worst affected of the six men, Mohamed 'Nino' Abdelhady, called the Elephant Man because of the extreme swelling of his head, on April 5th, told the Daily Mail that he is plagued by nightmares.

Still recovering in the hospital at the time, he explained what he remembered. "I started to feel ill," he said, "almost as soon as they had finished injecting me."

"I felt as if I had rocks on my head," he recalled, "and I must have started hallucinating."

"Help me," he told the newspaper that he screamed, "I'm dying."

Ryan Wilson, the most critically ill man, begged doctors to put him to sleep because he was in such agony. His family was warned that his heart, lungs and kidneys failed.

His sister-in-law Jo Brown, recalled the horrific moment when they saw Mr. Wilson in intensive care. She told reporters that his head had swollen to nearly three times its normal size, and that his neck was the same or wider than his head and that his skin had turned a dark purple.

Mr Wilson remained in a coma for three weeks, and upon awakening, learned that he may lose parts of his fingers and toes, which had turned black because of his reaction to the drug.

"I'm told it's like frostbite and my fingers will just fall off," he told the UK's News of the World recently.

In addition, Mr Wilson also suffered from heart, liver and kidney failure, septicemia, pneumonia and dry gangrene and is considered very luck to be alive, according to News Target on May 20, 2006.

The Parexel research was at the Phase I stage, where a drug is tested for safety with a small number of people who are given a tiny dose under careful supervision, not to determine whether the drug works, but to check for side effects, according to Q&A Drug trials by BBC News on March 16, 2006.

Experts say the recruitment of subjects for the Parexel trial left much to be desired. The web site that announced the recruitment hardly mentioned the potential risks, but elaborated at great length about the good pay, free food and "plenty of time to read or study or just relax, with digital TV, pool table, video games, DVD player and free Internet access.''

Parexel also recruits by placing ads online or in local papers, where critics say, they draw the attention of the young and poor. Once on the books, recruits often get automatic offers. “The offers keep rolling in via text message,” Tom de Castella, a former Parexel volunteer said in the March 19, 2006 Times Online. “£650 for three days here, £1,000 for a week there,” he said.

Ethicists shown the Parexel consent form, which is supposed to describe the experiment and its risks, told Bloomberg News, “the document didn't sufficiently inform participants of the therapy's possible dangers or properly depict the treatment as a novel drug that can disrupt the body's immune system.”

The 13-page form also exploited the subjects' need for money, they said, by threatening to withhold the 2,000 pound ($3,500) payment if the men left the test early.

Highly questionable research recruitment techniques are also occurring in the US. On November 29, 2005, in Texas, CBS News channel 42 reporter, Nanci Wilson, revealed records showing that staff at state mental hospitals in Texas help recruit patients into studies of experimental drugs not approved by the FDA.

At a state hospital in San Antonio, CBS News found 16 beds set aside to allow drug companies to conduct studies on mental patients under the state's care. CBS 42 asked Austin psychiatrist, Deborah Peel, to review some of the records they obtained.

Dr Peel said the situation raised serious questions as to whether this is moral and ethical treatment. "They are essentially turning the state hospital population into research subjects," she noted.

Texas hospital officials claim the mentally ill patients give informed consent by signing a detailed form describing the risks and benefits of participating in the study. But Dr Peel says, "I think there are real questions how informed their consent would be under those situations, because these are not people who have the means to choose to go elsewhere for treatment, and so, there's a powerful element of pressure, of coercion that they have to feel."

“Once again," Dr Peel points out, "we have people who have no means, who are dependent on the state system, and the state system is working hand-in-glove with private corporations."

In many studies, CBS news investigators determined that patients had been taken off drugs that were working and in the new study, some patients were given the experimental drug while others received a placebo.

Critics point out that for patients taking a new drug, there is no guarantee it will work, and the risks and long-term effects are not known. “To take people off medication when they have just been admitted for an inability to function and might have even been a harm to themselves or others, that raises real questions for me,” Dr Peel told CBC News.

What's worse, she says, is that patients are not told whether they are taking a placebo or a drug even when they are discharged from the hospital during the study. They could get suicidal, she said, or could harm others.

The FDA has ignored atrocities in research involving mentally ill subjects for years. Back in 1998, a review of the data on atypical antipsychotic drugs submitted to the FDA, obtained with FOIA requests by Robert Whitaker, revealed numerous safety problems for subjects who participated in the trials.

Mr Whitaker found that among 12,176 patients from the US and abroad at the time the data was submitted, there were 88 deaths, including 38 suicides, meaning there was an overall death rate of 1 out of every 138 patients, according to his article in the November 17, 1998 Boston Globe.

The suicide rate in trials was found to be 2 to five times higher than the norm. In the medical literature, Mr Whitaker reported, suicide rates for schizophrenics ranged from two to five deaths per 1,000 per year, while the rate in trials was close to 10 per 1,000.

In addition, he found that for the three approved drugs in the study - Zyprexa, Risperdal, and Seroquel - 60% of the 7,269 patients who received the drugs dropped out before the end of the study, which typically lasted six to 8 weeks.

In the 1990s the prospect of antipsychotic drugs gaining FDA approval, promised a major market for Big Pharma and therefore, drug companies needed to recruit trial subjects quickly. And drug companies were willing to pay top dollars to researchers for each patient recruited.

In the Boston Globe article, Mr Whitaker discusses a criminal case in Georgia that reveals just how far researcher are willing to go to meet recruitment goals.

Dr Richard Borison, chairman of the psychiatry department at the Medical College of Georgia, and Bruce Diamond, a pharmacologist on the school's faculty, were favorites for schizophrenia drugs and demonstrated a knack for rounding up psychotic patients quickly for trials funded Eli Lilly, Janssen, Zeneca, and Novartis.

As faculty members, Borison and Diamond were supposed to get approval for research and payments for trials were supposed to go the school. But according to Georgia authorities, who indicted the duo in early 1997, in 1989 they started having the drug makers send payments directly to them.

They simply opened an office across from the school, hired a commercial service to do ethical reviews of their studies, and placed their staff on the school's payroll but kept all the money for themselves.

As unbelievable as it may seem, the scheme worked for about 7 years. From 1989 to 1996, Borison and Diamond made over $10 million including more than $4 million from schizophrenia drugs, according to the indictment and testimony during an investigation by the Augusta Veterans Affairs Hospital, where Borison was chief of psychiatry.

And these guys were slick. To recruit the mostly male patients, they hired good-looking young women, who testified that they were paid bonuses that ran into the thousands, and one staffer was even given a Honda Accord.

To find their recruits, workers looked for mentally ill patients who were stable and living in the community and offered them $150 to check into the VA so they could be in a study. Patients already in locked wards were offered cigarettes to participate.

Study coordinators, many with no medical training, determined whether a patient belonged in a study. According to an FDA investigation, untrained staff drew blood samples and adjusted doses of the drugs, and Borison and Diamond hardly ever saw the patients at all.

But the two researchers lived high off the hog, according to Georgia authorities. They socked away more than $5 million in cash and securities, spent nearly a half a million on antiques and drove Mercedes-Benz vehicles.

But as the old saying goes, all good things must end. In December, 1997, Diamond pleaded guilty to theft and bribery charges and was fined, $125,000, sentenced to 5 years in prison, and ordered to pay $1.1 million to the college.

Borison pleaded guilty to theft and racketeering charges, was sentenced to 15 years in prison, fined $125,000, and ordered to pay $4.26 million to the college.

To cover all bases, over the years, Big Pharma has also become adept at corrupting the judicial process.

For instance, Dr Bruce Levine, PhD, Clinical Psychologist and author of, World Gone Crazy, tells a story about Eli Lilly corrupting the judicial process in a case that began in 1989 when Joseph Wesbecker opened fire at his former place of employment, killing 8 people and wounding 12 more, before committing suicide, a month after he began taking Prozac. The victims of the shooting sued Eli Lilly, claiming that Prozac had pushed the guy over the edge.

It has long been known that Prozac induces violence in some patients but the FDA never required Lilly to list violence on the drug’s label. But as it turns out, five of the 9 members on the 1991 FDA advisory panel investigating the association between Prozac and violence that voted against requiring a warning label for violence, had ties to Big Pharma and two of the members had served as lead investigators for Lilly-funded Prozac studies.

The Wesbecker trial did not take place until 1994, but in the meantime, according to Dr Lavine, “Eli Lilly had been settling many Prozac violence cases behind closed doors.”

In fact, he says, more than 150 Prozac lawsuits had been filed by the end of 1994, so “it was looking for a showcase trial that it could win.”

A crucial component of the victims’ legal strategy in the Wesbecker case was for the jury to hear about Lilly’s history of reckless disregard toward consumers, especially about the drug Oraflex, introduced in 1982 but taken off the market 3 months later.

“A US Justice Department investigation linked Oraflex to the deaths of more than 100 patients,” Dr Lavine notes, “and concluded that Lilly had misled the FDA.“

In the end, Lilly was charged with 25 counts related to mislabeling side effects and pled guilty.

At the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be too prejudicial for the jury to hear and the Judge initially agreed. However, when Lilly attorneys used witnesses to testify about it’s superb system of collecting and analyzing side effects, the Judge said that Lilly had opened the door to evidence to the contrary and so the Oraflex information would also be allowed in.

However, to Judge’s amazement,” Dr Lavine says, “victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case.“

It was later learned that Lilly was successful in corrupting the judicial process in the case by cutting a secret deal with victims’ attorneys to pay them and their clients not to introduce the damaging Oraflex evidence.

However, Dr Lavine says, the Judge “smelled a rat" and fought for an investigation, and in 1997, Lilly quietly agreed to the verdict being changed from a victory to “dismissed as settled.”

Legal experts are finding ways to expose and punish Big Pharma for conducting fraudulent research that requires no involvement by the nation's compromised regulatory agencies. Barry Turner, Lecturer in Law at Leeds Law School in the UK, is a great fan of the False Claims Act legislation in the US.

As an academic lawyer, he has for a number of years been involved in litigation regarding the activities of the pharmaceutical industry and for the past two years, he has been involved in Qui tam litigation preparation.

"Tying Qui tam into human rights and civil liberties issues is easy," Mr Turner says. "When President Lincoln initiated this law in 1863 it was because Union soldiers were going into battle in shoddy boots and uniforms equipped with guns and ammunition that were third rate," he explains. "All because 'businessmen' saw the war as a gravy train."

"Qui tam," Mr Turner explains, "protects taxpayers and since tax revenue is the lifeblood of any state, any evasion of liability or deliberate defrauding of a taxpayers is an attack on all taxpayers and consequently all citizens."

Qui tam in its long history, he says, has brought to book many crooks who stole from the US taxpayer and is based on the individual citizen being able to blow the whistle for the benefit of fellow citizens and the country.

The more recent Sarbanes-Oxley Act of 2002 (SOX), was enacted in the wake of the Enron and WorldCom scandals, and was designed to restore investor confidence in the nation’s financial markets by improving corporate responsibility through changes in corporate governance and accounting practices and by providing whistleblower protection to employees of publicly traded companies who report fraud.

SOX contains a civil and a criminal whistleblower provision. Section 806, creates a civil cause of action for employees who have been subject to retaliation for whistleblowing, and Section 1107, makes it a felony for anyone to knowingly retaliate against or take any action harmful to any person, including interfering with employment, for providing truthful information relating to the commission or possible commission of a federal offense.

According to Mr Turner, SOX is not limited to shareholders of a company. "What needs to be understood," he says, "is that many millions of people who own no stock at all get defrauded in scams all the time."

"Those who pay into pension funds are vulnerable to the financial shenanigans not only of fund managers but of boards of companies," he explains, "and CEO's that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices."

SOX came into being to prevent those financial shenanigans, he says. "The fat cats may lose a small amount of their stake in any scam," he points out, "but the little man as ever stands to lose all."

One of the features of SOX, he says, is the ability to bring an action against those who recklessly and fraudulently deal with stockholders money. Big Pharma, and its handmaiden psychiatry, he notes, is built on fraud.

For example, Mr Turner explains, Ritalin fraud consists of labeling millions of children as basket cases based on fraudulent research and a consensus of the vested interest.

"SSRI fraud," he advises, "extends depression into the world of normal human experience to ever-extend the peddling of the often useless and frequently dangerous treatments."

In other instances, he says, many poor and elderly people are starved of life saving drugs because the budgets of Medicare and Medicaid are bled dry by claims from drug companies for 'me too' drugs that in many cases are superfluous.

"Even where there is some justification for the use of these drugs," he explains, "there is a drive to constantly increase the dose above the minimum effective one because a 'minimum effective dose' to the drug company means minimum
effective profit."

"Where money is diverted from real healthcare provisions, to a profit greedy industry that manufactures an illness to fit the drug," he notes, "rather than
provide drugs for real illnesses, then the most fundamental of constitutional rights 'Life, Liberty and the Pursuit of Happiness' is most at risk."

Every unnecessary dose of Ritalin, Prozac, Paxil, and other psychiatric drugs prescribed and paid for with US tax dollars, he says, deprives patients dependant on state healthcare programs of drugs they need for cancer, diabetes, heart disease and other serious conditions.

In addition, Mr Turner points out that, "the marketing of these drugs and the ever expanding definition of psychiatric disorder that is part of this marketing strategy labels, discriminates against, and stigmatizes hundreds of thousands of American Citizens."

"It is indeed a dramatic irony," he says, "that in very many of these cases the US taxpayer gets to fund an industry that acts in a manner so alien to the American Constitutional ideals."

For purposes of the litigation, “knowingly” is defined as: (1) Actual knowledge of the false information; (2) Acts in deliberate ignorance of the truth or falsity of the information; or (3) Acts in reckless disregard of the truth or falsity of the information.

Therefore, according to Mr Turner, "inducing people to invest in companies that engage in illegal and reckless activity is a violation of SOX."

"Inducing people to take vast amounts of drugs that are known to be harmful and deliberately hiding the known dangers is a violation of SOX," he contends.

"One day this edifice will come tumbling down," he says, "and what will the investors in Big Pharma say then?"

In light of the Vioxx disaster, Mr Turner says, we should perhaps ask people who invested in Merck.

"Those at the top of this company," he notes, "gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed."

"Those who today peddle drugs for fictitious illnesses and push dangerous and useless medications on the children," he warns, "in our societies are doing just this."

Merck acted with reckless disregard for the truth because it had prior knowledge of the adverse effects of Vioxx. The same goes for Eli Lilly and its prior knowledge of the lack of efficacy of Prozac and GlaxoSmithKline's knowledge of Paxil's suicide ideation.

While suppressing negative studies, these companies placed drugs on the market that were known to be faulty in one way or another. All of these drugs have cost taxpayers dearly, not to mention the personal suffering they have inflicted in other ways.

In considering other acts of fraud, Mr Turner looked at the Pharma backed charities that are based on fraudulent research to see what Federal laws they may be violating.

"Since a number of imaginative illnesses are based on this fabricated research and since a number of charities are based on the 'imaginative illnesses' that arose out of the imaginative research," he says, "its just a matter of connecting the dots."

Because charities receive tax breaks, he says, fraudulent charities defraud US taxpayers.

"The fraud in this industry is not divided into that which injures by over drugging and that which cheats taxpayers and stockholders out of their money," he explains. "They are two sides of the same counterfeit coin."

Mr Turner says we must tackle them together, and that lawyers in the US should be actively seeking clients who have lost money by these frauds and getting the matter before the Security and Exchange Commission now.

Information for injured parties can be found at Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/Pharma.html

Evelyn Pringle
evelyn.pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)

Posted by MBVIC at 11:01 AM | Permalink

Bioworld Today
By Aaron Lorenzo
Washington Editor

The federal government agreed to pay $165 million to Human Genome Sciences Inc. under a contract to supply ABthrax (raxibacumab) to the Strategic National Stockpile.


The order calls for 20,000 courses of the therapeutic from the Rockville, Md.-based company, which first must receive licensure under an emergency use authorization before delivering the product. Then it would receive about 90 percent of the total payment. The events are expected concurrently in 2008, and fulfilling the contract's terms would provide HGS its first product sales.

"It's nice to have a top-line number of $165 million," said Andrew McDonald, an analyst with ThinkEquity Partners LLC in San Francisco. But he cautioned that the payment horizon remains a couple of years away. "There is a lot of work that has to be done to earn that money," he told BioWorld Today.

On Tuesday, shares in the company (NASDAQ:HGSI) gained 16 cents to close at $9.96.

The award, HGS President and CEO H. Thomas Watkins said in a conference call, represents "one more important step" in transforming HGS from a discovery firm into a development and commercialization company. He suggested that HGS could supply additional ABthrax doses to the stockpile down the road - HHS could have ordered up to 100,000 doses - as well as to other nations seeking to shore up their biodefense capabilities.

But McDonald warned that stockpiling is viewed as "more of a one-time event rather than something that's going to occur periodically." As a result, he said any potential payments for future orders would be "discounted heavily" given that "it's really hard for investors to value" such projections.

The award, made under the Project BioShield Act of 2004, was meted out by the Department of Health and Human Services. It follows on the heels of another BioShield contract announced earlier this month, a $362 million award for a botulism treatment from Cangene Corp., of Winnipeg, Manitoba. (See BioWorld Today, June 2, 2006.)

ABthrax's efficacy has been demonstrated in multiple animal models, with blood levels of the product exceeding those needed to provide protection from anthrax toxin, and its safety and tolerability has been shown in a Phase I trial that involved 105 healthy adult volunteers. The government decided to move forward with the order after reviewing those findings in conjunction with its own comparative laboratory testing of ABthrax that HGS supplied in October.

The company will produce ABthrax in its manufacturing facilities in Rockville, a 130,000-square-foot site at which it has developed required assays and a scalable purification process. "ABthrax will be the fifth monoclonal antibody that we have scaled up in this facility," Watkins said, "and our success rate in delivering cGMP material from this facility is excellent."

HGS also will complete additional laboratory and clinical testing required to support a biologics license application with the FDA, and to support the use of ABthrax in patients with inhalational anthrax disease in the event of an emergency prior to agency approval.

"We expect to meet very soon with regulatory authorities to confirm their agreement with the program that we've designed," David Stump, the company's executive vice president of drug development, said in the conference call.

He noted that the company expects to conduct multiple clinical tests in several hundred people, including a confirmatory safety study in healthy volunteers and smaller studies to investigate interactions with antibiotics and vaccines.

Confirmatory animal efficacy studies will employ survival endpoints, including a combination trial with antibiotics, as well as a vaccination study to ensure that ABthrax will not interfere with a person's ability to mount a natural immune response.

"We expect to complete these studies well within the timeline as required by the contract," Stump said.

The FDA has conferred fast-track and orphan drug status on the product, which was the first investigational agent against anthrax infection to be evaluated in a clinical study following the 2001 anthrax attacks in the U.S. A human monoclonal antibody to Bacillus anthracis protective antigen, it was discovered and developed by HGS using technology integrated into the company as part of a collaboration with Cambridge Antibody Technology plc, of Cambridge, UK.

ABthrax is designed to overcome limitations associated with vaccines and antibiotics that combat anthrax, "a third option" to complement the other two, Stump said. Compared to the current anthrax vaccine, which takes multiple injections to reach and maintain immunity, ABthrax confers immediate protection in a single dose once appropriate blood levels of the product are achieved. In addition, ABthrax acts against anthrax bacteria's deadly toxins, against which antibiotics are not effective. ABthrax also could prove effective against antibiotic-resistant strains of anthrax.

The government has named anthrax a material threat to national security, along with botulism and smallpox, as well as radiological hazards.

The contract marks the second major event for HGS in recent weeks. Earlier this month, the company partnered its chronic hepatitis C product, Albuferon (albumin-interferon alpha 2b), in a deal potentially worth $550 million with Novartis AG, of Basel, Switzerland. Already it has partnered cancer product LymphoStat-B with GlaxoSmithKline plc, of London. (See BioWorld Today, June 7, 2006.)

Both products are expected to enter Phase III before the end of the year.

McDonald noted that the eventual ABthrax payment would help support the growing expenditures at HGS, which he said burns more than $250 million per year. With cash reserves projected at about $715 million at the end of this quarter, bolstered by full compensation on the ABthrax contract in 2008, he estimated that the company's balance would carry it through Albuferon's projected approval in 2010. McDonald has not forecast an approval timeline for LymphoStat-B.

"We are fully confident of our ability to move all three of these programs forward," Watkins said. "We are very well positioned for the future, and we have the resources to accomplish what we need to."

Posted by MBVIC at 11:53 AM | Permalink

Press Release
Department of Defense

A panel of military physician experts has concluded that vaccinations may have caused the death of a 26-year-old Army soldier.

The soldier, Pfc. Christopher "Justin" Abston, received smallpox and injectable influenza vaccines in Nov. 18, 2005, at Fort Bragg, N.C., 16 days before suffering sudden death in his barracks room.

Following evaluation of multiple specialized test results, the panel considered a cause-and-effect relationship to be "possible." The smallpox vaccine received by Abston is known to cause an inflammation of the heart muscle or myocarditis, a condition found at his autopsy.

Evidence of the vaccinia virus, the main ingredient of smallpox vaccine, was not found in his heart muscle, but evidence of a different virus, parvovirus B19, was found. Natural infection with parvovirus B19 is another known cause of heart inflammation and death. The expert panel cautioned that the findings pointing to
vaccinations were neither probable nor unlikely, but they do suggest the possibility that the vaccines may have caused Abston's death.

Among the one million military personnel given smallpox vaccine since December 2002, 120 developed myocarditis or similar conditions, but none of them died. DoD screens all personnel to be given smallpox vaccinations and about eight percent are excluded due to screening criteria. It also advises all smallpox vaccine recipients, who develop chest pain after smallpox vaccination to seek medical care without delay. In the 120 cases mentioned above, such chest pain most often occurred in the first three weeks after smallpox vaccination.

The DoD conducts its smallpox vaccination program to protect troops assigned to U.S. Central Command, U.S. Forces Korea, or designated units with homeland defense missions.

Posted by MBVIC at 8:56 PM | Permalink

By Donna Miles
American Forces Press Service

The Defense Department has no plans to discontinue its smallpox vaccination program, despite yesterday's announcement that vaccinations may have caused a soldier's death.
A panel of military doctors concluded that vaccinations may have caused the death of Army Pfc. Christopher "Justin" Abston.


Abston received the smallpox and injectable influenza vaccines in November at Fort Bragg, N.C., and died suddenly in his barracks room 16 days later, on Dec. 4, Pentagon officials said.

His autopsy revealed an inflammation of the heart muscle, or "myocarditis." The smallpox vaccine is one of several known triggers of this condition. Evidence of another known trigger for the condition was found during the autopsy.

"Evidence of the vaccinia virus, the main ingredient of smallpox vaccine, was not found in his heart muscle, but evidence of a different virus, parvovirus B19, was found," a Defense Department release stated. "Natural infection with parvovirus B19 is another known cause of heart inflammation and death."

A panel of military medical experts determined it is "neither probable nor unlikely," merely "possible," that vaccinations caused Abston's death.

Abston is the only servicemember whose death has been linked to the smallpox vaccine. Of 1 million servicemembers vaccinated through the program, 120 developed myocarditis or similar conditions, but all others survived.

DoD initiated the smallpox vaccination program in December 2002 to protect servicemembers from the highly contagious smallpox disease, Air Force Lt. Col. Ellen Krenke, a Pentagon spokeswoman, told American Forces Press Service. The program is used to protect troops assigned to U.S. Central Command, U.S. Forces Korea, or designated units with homeland defense missions.

"The smallpox vaccine has been given billions of times to Americans and people all over the world in the last century," Krenke said. Hundreds of studies have assessed the vaccine, and DoD will continue to monitor the safety of the smallpox vaccine and all other vaccines it uses to protect servicemembers, she said.

Dr. William Winkenwerder, assistant secretary of defense for health affairs, expressed condolences to Abston's family and regret about his death. "Medicine remains an inexact science," he said. "And when we lose one of our soldiers, we recognize how much about medicine that we still do not know."

Posted by MBVIC at 8:52 PM | Permalink

Global Security Newswire

Required military vaccines might have killed a 26-year-old U.S. Army soldier in 2005, the U.S. Defense Department said yesterday (see GSN, Dec. 5, 2005).


Pfc. Christopher Abston received smallpox and influenza vaccine injections in November. He died 16 days later, on Dec. 4 in his Fort Bragg, N.C., barracks, Reuters reported.

A medical expert panel said it was “possible” the vaccines administered by the military caused the death, the Pentagon said in a release. An autopsy report revealed that Abston experienced myocarditis, or an inflammation of the heart muscle, a reaction that can be triggered by the smallpox vaccine.

“The expert panel cautioned that the findings pointing to vaccinations were neither probably nor unlikely, but they do suggest the possibility that the vaccines may have caused Abston’s death,” the release said.

Military troops have questioned the safety of required shots and some have been discharged after refusing to be vaccinated.

The Pentagon said that out of 1 million military personnel who have received the smallpox vaccine since 2002, 120 people contracted myocarditis or comparable conditions. Abston is the only reported fatality.

An earlier panel said the 2003 death of an Army medic might have been linked to a set of mandatory vaccinations, including shots for anthrax and smallpox (Will Dunham, Reuters, June 22).

Posted by MBVIC at 12:01 PM | Permalink

Reuters
By Will Dunham

WASHINGTON (Reuters) - A panel of armed forces medical experts has found that vaccines required by the military may have killed a 26-year-old Army soldier last year, the Pentagon said on Thursday.


Pfc. Christopher "Justin" Abston died on December 4 in his barracks room at Fort Bragg, North Carolina, 16 days after getting smallpox and injectable influenza vaccines, officials said. The panel concluded it was "possible" the vaccines were the cause of death, the Pentagon said in a statement.

An autopsy showed Abston suffered from an inflammation of the heart muscle, or myocarditis, a condition the smallpox vaccine is known to cause, the Pentagon said.

"The expert panel cautioned that the findings pointing to vaccinations were neither probable nor unlikely, but they do suggest the possibility that the vaccines may have caused Abston's death," according to the statement.

Some U.S. troops have expressed concern about the safety of vaccines required by the military. A small number who have refused to get the shots have been thrown out of the military.

In November 2003, the Pentagon said medical experts found the death of an Army combat medic, Spc. Rachel Lacy, 22, in April 2003 may have been caused by a combination of vaccinations required by the Pentagon, including those for anthrax and smallpox.

The military requires troops serving in Iraq, Afghanistan, South Korea and in some homeland defense missions to get smallpox vaccinations. The Pentagon describes the shots as an important "force protection" measure in an era when potential enemies may be armed with biological weapons.

Of the million U.S. military personnel given the smallpox vaccine since 2002, 120 were known to have developed myocarditis or similar conditions, but none had died, the Pentagon said.

The Defense Department screens everyone who will get smallpox shots, and as a result about 8 percent are excluded due to medical concerns.

Posted by MBVIC at 8:55 PM | Permalink

By Tricia Bishop
Baltimore Sun reporter

Human Genome Sciences announced yesterday its first major contract with the U.S. government for an experimental anthrax drug, more than four years after the bacterial infection terrorized the country. But Wall Street's initial reaction was tepid.


The federal government plans to purchase 20,000 doses of the Rockville biotech's treatment for $165.2 million, with delivery and 90 percent of the payment expected in 2008. When complete, the deal will give the 14-year-old company its first-ever product sales revenue.

While shares of Human Genome traded at more than double their normal volume, the stock price closed up by only 16 cents, or 1.6 percent, to $9.96.

Chief Executive Officer H. Thomas Watkins characterized the arrangement, which is contingent on the completion of certain clinical studies and receiving approval from the Food and Drug Administration, as "one more important step in the transformation of HGS."

The company has released a string of announcements recently highlighting its efforts to move from the discovery phase of drug development toward commercialization.

Two weeks ago, Human Genome announced a $507 million collaboration with Switzerland's Novartis to develop and commercialize its hepatitis C drug, Albuferon.

Yesterday, Human Genome reiterated intentions to move that drug, as well as a lupus treatment called LymphoStat B, into late-stage clinical trials this year. HGS also recently sold its headquarters, some land and a new manufacturing facility to put $380 million in its bank.

"As far as I'm concerned, they're doing exactly what they need to do," said Edward Tenthoff, an analyst with Piper Jaffray & Co. in New York. His firm has picked Human Genome as the top stock for the second half of the year, with a predicted target price of $18.

In October, the company announced that the government bought a small amount of the drug, called "ABthrax," to test and could eventually purchase up to 100,000 doses as part of its plan to stockpile medications needed during a public health emergency, including a terrorist attack and a flu outbreak.

Anthrax, a bacterium that releases lethal toxins in the body, killed five Americans in the fall of 2001 following the Sept. 11 terrorist attacks, sparking further panic among thousands, who were no longer sure it was safe to open their packages or fly.

Investors have been skeptical of such plans, unsure of the government's follow-through, Tenthoff said: "It's proven so hard to get money out of the government."

But he believes that is changing and points to the multibillion-dollar plan to prepare for a pandemic influenza outbreak and efforts to revamp bioterrorism legislation as proof. "It really seems to me that they're starting to get their act together."

Others were not so convinced.

Gilad Aharon, an analyst with Toronto-based Infinium Capital, said he expects the government to spread several small contracts such as Human Genome's around to various companies, and this is nothing to "get excited about."

Human Genome typically burns through about $60 million in cash per quarter, he said, and after expenses are accounted for, the $165 million "buys them another quarter and a half in cash."

Many small companies, including PharmAthene Inc. in Annapolis, are working on anthrax infection treatments and hoping to get their hands on federal money designated for such efforts.

Last year, the Department of Health and Human Services spent $122.7 million to buy 5 million doses of an anthrax vaccine made by Michigan's BioPort Corp. And the year before that, the department awarded VaxGen Inc. of California $876 million for 75 million doses of its anthrax vaccine.

"In reality, there are many competitors," said Aharon, who expects Human Genome's stock to stay in the $10 range over the next year.

Currently, there are only two approved anthrax treatments. Antibiotics can kill the bacteria, but not the deadly toxins after they've been released in the blood. And the vaccine takes weeks to produce immunity, requires multiple injections over 18 months and an annual booster shot.

ABthrax is thought to provide immediate immunity and work on the toxins that antibiotics miss.

"This important addition to the Strategic National Stockpile will provide physicians a way to neutralize the deadly toxin anthrax bacteria produces," said Gerald Parker, Health and Human Services acting assistant secretary for public health emergency preparedness, said in a statement. "We found that it is the toxin which accounted for the majority of anthrax-related deaths during the anthrax attacks of 2001."

Still, analysts Tenthoff and Aharon (neither of whom own Human Genome stock or work for firms that have investment relationships with the company) believe the deal is likely a one-time thing that will help Human Genome's bottom line, but might not provide much of a future foundation.

"They're still far away from significant cash flows," Aharon said. "I mean, this is a company that if all goes well for them, will become cash positive in the next decade, and there's nothing they can really do to accelerate the pace at this time. I will credit them that they're trying."

Posted by MBVIC at 12:36 PM | Permalink

Global Security Newswire

The U.S. government plans to spend $165 million on an experimental anthrax infection treatment to add to its emergency stockpile of WMD countermeasures, the Washington Post reported today (see GSN, May 8).


Human Genome Sciences Inc. of Rockville, Md., is expected today to announce the sale of 20,000 doses of Abthrax. The purchase is being made through Project Bioshield, the federal government’s $5.6 billion effort to build up stocks of various treatments, including vaccines and drugs, for exposure to chemical, biological, nuclear or radiological weapons.

The government has also been considering an anthrax treatment produced by Canadian biotechnology firm Cangene Corp. However, Cangene is not expected to receive a contract today, the Post reported.

Abthrax would likely be used following exposure to anthrax. The Food and Drug Administration has not yet approved the product, but it could already be used in the event of an emergency.

Tests on 105 people indicated the drug is safe, but several hundred more will need to be tested. It is unclear how much the proceeds of the sale would go into the continued testing of the product (Michael Rosenwald, Washington Post, June 20).

Posted by MBVIC at 12:56 PM | Permalink

Washington Business Journal
by Neil Adler, Staff Reporter

A former secretary of the U.S. Department of Health and Human Services has joined the board of directors at Emergent BioSolutions. Gaithersburg-based Emergent BioSolutions, a private biopharmaceutical company, said Wednesday that Louis Sullivan, secretary of the Department of Health and Human Services from 1989 to 1993, was named to its board.


Sullivan, who is also on the board of Silver Spring-based United Therapeutics, currently serves as president emeritus of the Morehouse School of Medicine in Atlanta, where he previously served as president from 1981 to 1989, and again from 1993 to 2002.

He is a director of BioSante Pharmaceuticals, Inhibitex and Henry Schein.

Previously, he served on the boards of some business heavyweights, including Bristol-Myers Squibb, 3M, Georgia Pacific and Cigna.

Sullivan is also a founder and chairman of Medical Education for South African Blacks, a director of the National Center for Addiction and Substance Abuse at Columbia University and a former trustee of the Morehouse School of Medicine and of Africare.

"Dr. Sullivan is a renowned leader in matters of public health and safety both nationally and abroad," says Fuad El-Hibri, chairman and CEO of Emergent, in a statement.

"His academic and medical accomplishments and his distinguished public service have had a global impact on the advancement of health care and our company is very fortunate to have access to his leadership and guidance."

Emergent, thought by many biotech industry observers to be one of then next local drug firms to go public, employs more than 450 people between its facilities in Maryland, Michigan, the United Kingdom, Germany and Singapore. The company's subsidiary, BioPort, makes the only Food and Drug Administration-approved vaccine for anthrax.

Emergent has a handful of other drug and vaccine candidates in clinical and preclinical testing.

Posted by MBVIC at 12:13 PM | Permalink

FIRST PUBLISHED ON REDFLAGS ON JUNE 16, 2006
http://www.redflagsdaily.com/yazbak/2006_jun16

By F. Edward Yazbak, MD, FAAP

For years, the Centers for Disease Control and Prevention (CDC) has been telling anyone who would listen: “Every year in the United States, on average: 5 percent to 20 percent of the population gets the flu, more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu.” (1) It is not clear how the specific statistic — 36,000 American deaths a year “on average” — was formulated or from what sources it was derived. It seems to have just suddenly appeared, like a rabbit from a top hat. It certainly could have been any other number of thousands of cases. After all, what are a few thousand deaths up or down?


No one knows when the next number change will come but, when it does, it is guaranteed to be an increase. Scaring people, especially old people, out of their wits always sells vaccine and that seems to have become the CDC’s main purpose.

Another well-kept secret is over how many years the influenza deaths were “averaged.” Did the CDC calculate “average deaths” from 2000 to 2004 or from
1980 to 2004?

To have 36,000 deaths “on average,” there must be years with 26,000 deaths and about the same number of years with 46,000 deaths and, not to belabor the point, as many years with 16,000 deaths as with 56,000. At least, this is what most people would think averaging and “on average” mean.

The past influenza season came and went very quietly because the CDC was busy with dying birds in the Far East and Turkey. We will never find out where exactly the most recent “deaths from flu” will fit on the curve, but it is a good bet that 2005-2006 will not be, propaganda-wise, a “real good year.”

Testifying before the committee on government reform of the U.S. House of Representatives on Feb. 12, 2004, CDC Director Julie L. Gerberding, MD, carefully stated that “CDC scientists estimate that an average of 36,000 people die from influenza-related complications each year in the United States.” (2)

It is not clear why the director made the distinction, while under oath, between deaths from the flu and deaths from complications of the flu. A few people, including this writer, think there is a distinct difference between the two; many others do not think so.

To place the CDC influenza deaths in perspective, the U.S. lost 33,741 officers and enlisted men and women in Korean War battles from 1950 to 1953. (3) And a special communication published by the Journal of the American Medical Association listed 43,000 deaths due to motor vehicle crashes and 29,000 involving firearms in the U.S. in 2000. (4)

The National Vital Statistics Report for 2001, published on Sept. 18, 2003 [Vol. 52, No. 3], was the last official U.S. government report on influenza mortality before the CDC director’s appearance at the February 2004 Congressional hearing. Certified figures about Influenza mortality [J10-J11] were listed on page 31 of the report. (5)

There were, in all, 257 influenza deaths recorded in 2001.

Of those, 13 deaths were under the age of 5; 50 were between 5 and 54; 21 from 55 to 64; 21 between 65 and 74; 56 from 75 to 84; and 96 were 85 years old or older.

Also in 2001, there were 61,777 official deaths due to pneumonia (J12-J18) of which 48,686 (79 percent) were 75 years old or older.

The same document (table 11, page 35) lists the reciprocal number of deaths per 100.000 population. In 2001, influenza-pneumonia deaths (J10-J18) amounted to 21.8 per 100.000 with influenza at 0.1 and pneumonia at 21.7.

With the U.S. population being around 284 million in 2001, it would seem that the calculated number of 284 (0.1/100.000) deaths from influenza would be close enough to the actual listed number of 257.

The following should be kept in mind:

“Pneumonia” is caused by bacteria, viruses and fungi. Elderly patients (75 years and over) who have laboratory confirmed influenza disease may develop pneumonia but die from other underlying serious conditions, such as heart or kidney failure to name just two. It is not known how many of the 48,686 elderly individuals who died in 2001 had received the influenza vaccine that year. People of that age are usually vaccinated early in the season and certainly more frequently than others. In the U.S., influenza/influenza-like illnesses only occur during the flu season, a period of three months on average and rarely four months. Pulmonary complications and
specifically deaths due to influenza will only occur during that short period, while
other causes of pneumonia deaths exist year-round.

Most people who have influenza-like illness, as the condition is fondly referred to by the CDC, do not have influenza; only a small percentage of them are ever confirmed by culture or other accurate laboratory means.

For the period 2000-2005, influenza virus positive cultures were 11 to 18.9 percent of the obtained cultures with a mean of 12.5 percent. It is well known that the virus strains in the community may be different from those in the available vaccine. Because immunity is strain-specific, vaccination in such cases is essentially ineffective in preventing disease. The percent of antigenic match between 2000 and 2005 varied from 11 to 63.2 percent with a mean of 54.2 percent. The maximum effectiveness of the vaccination effort, therefore, ranged between 2.1 percent in 2003-2004 and 11.5 percent in 2002-2003 with a mean of 7.2 percent. (6)

Taking all these facts into consideration, it is safe to say that only a small percentage of the 61,777 individuals who died of pneumonia in 2001 actually had influenza. Clearly, therefore, a large majority of individuals who died that year of pneumonia did not die of influenza or influenza-related complications.

In addition, the CDC figures clearly show that a large percentage of those who died were elderly and, historically, the elderly, as a group, have always been better vaccinated. As to the 257 individuals who were actually listed as influenza deaths in the 2001 statistical report, the influenza virus was actually identified in only 18 of them, the 18 classified as J10. (6)

Apparently in 2001, not even 257 people died of influenza or influenza-related complications.

The Monthly Vital Statistics Report of Sept. 17, 1981 sheds additional light on the issue. Under pneumonia and influenza, the report states: “An estimated 52,720 deaths in 1980 were attributed to pneumonia and influenza. The age-adjusted death rate for this cause increased about 14 percent from 11.1 per 100,000 population in 1979 to 12.6 in 1980, reflecting the influenza epidemics in 1980 and the absence of one in the previous year. For pneumonia and influenza, death rates increased for the age groups 35 years and over.” (7)

The above statement by none other than the CDC suggests that around 1.5 deaths per 100,000 were or could have been attributed to influenza or influenza complications in 1980, an epidemic year, when one would have expected a very large number of cases and more severe illness and certainly in a period when influenza vaccination was not as popular as it is now.

Considering that the U.S. population was around 226.5 million in 1980, 1.5
deaths per 100.000 would translate to around 4,000 deaths that year. So here
we have official CDC statistics listing around 4,000 deaths, unconfirmed by viral cultures, from influenza and influenza-related complications in 1980, a banner year, and maybe 18 or 257 in 2001 and the propaganda machine is still talking about “an average of 36,000 deaths” a year. How preposterous.

References

1. Key Facts about Influenza and the Influenza Vaccine, CDC.
Available at http://www.cdc.gov/flu/keyfacts.htm

2. J.L. Gerberding. Protecting the Public's Health: CDC Influenza Preparedness Efforts. Testimony before the Committee on Government Reform U.S. House of Representatives, Feb. 12, 2004.
Available at http://www.cdc.gov/washington/testimony/In2122004200.htm

3. America's Wars: U.S. Casualties and Veterans.
Available at http://www.infoplease.com/ipa/A0004615.html

4. A.H. Mokdad et al. Actual Causes of Death in the United States, 2000. JAMA. 2004; 291: 1238-1245.
Available at http://jama.ama-assn.org/cgi/content/abstract/291/10/1238

5. E. Arias et al. Deaths: Final Data For 2001. National Vital Statistics Reports. Volume 52, Number 3. Sept. 18, 2003.
Available at http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_03.pdf

6. D.M. Ayoub, F.E. Yazbak. Influenza Vaccination During Pregnancy: A Critical Assessment of the recommendations of the Advisory Committee on Immunization Practices. J. Am Phys Surg. 2006; 11(2): 41-47.
Available at http://www.jpands.org/vol11no2/ayoub.pdf

7. Annual Report of Births, Deaths, Marriages and Divorces: United States 1980. Monthly Vital Statistics Report: Vol. 29, No.13. Sept. 17, 1981.
Available at http://www.cdc.gov/nchs/data/mvsr/supp/mv29_13.pdf

Posted by MBVIC at 11:52 AM | Permalink

The Washington Post
By Marc Kaufman

After months of trying to get firsthand information from a government official familiar with a controversial new antibiotic, Sen. Charles E. Grassley (R-Iowa) marched into the Department of Health and Human Services headquarters yesterday asserting his congressional right to receive the data.


After a brief meeting with senior HHS and Food and Drug Administration officials, Grassley departed empty-handed and angry.

"This is extraordinary for me," the senior Republican said outside the headquarters. "I haven't had to go to an agency like this since 1983 to get information I requested.

"I smell a coverup."

FDA officials denied any impropriety, saying they were cooperating with Grassley's staff and had sent 400 boxes of documents related to the approval and safety of the drug, Ketek. Some information had to be withheld, the agency said, because of continuing investigations.

The senator, a persistent critic of the FDA, said he went to HHS out of frustration over the agency's refusal to make available one employee involved with an investigation into the antibiotic. A powerful drug approved in 2004 for the treatment of chronic lung and sinus infections, it has been at the center of the newest controversy over the agency's actions in reviewing new drugs and monitoring their safety.

Liver failure and disease associated with the drug have been reported, but the overriding issue involves the integrity of the clinical trials done to establish its safety and efficacy.

The agency acknowledges that there were major improprieties in a 25,000-patient clinical trial done for the drug's developer, Aventis. One person has gone to prison for fraud in connection with that trial, data from several other trial sites have been discarded because basic standards were not met, and the agency told the company it could not say anything about the trial results on its product label.

Nonetheless, the FDA allowed Aventis to use much of the data to support the company's contention that the drug is safe. It also allowed Aventis to present the data to an FDA advisory panel without telling its members of the widespread fraud allegations clouding the trial. Documents show that some FDA employees argued that the trial should have been discarded because of the company's inadequate oversight.

Grassley has pressed to speak with an agent in the FDA's Division of Scientific Investigations who, he said, "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty. Did FDA managers turn a blind eye and let the drug maker off too easy, or did the FDA do the right thing?"

In reply, FDA spokeswoman Susan Bro said: "We would like to do whatever we can to help [Grassley] fulfill his constitutional duty as well as ours to the American people. However, we will not compromise an ongoing investigation."

FDA officials also said that having a senator interview a government investigator in the midst of an inquiry raised the possibility of politicizing criminal proceedings.

Ketek is one of the few antibiotics developed and approved in recent years. The agency has made a priority of encouraging companies to work in the field of antibiotics, which inevitably become less useful as bacteria become resistant.

"We don't want to disincentivize companies interested in going after these bad bugs," Bro said.

The maker of Ketek, now named Sanofi-Aventis, did not return a phone call. Earlier this month, the company stopped recruiting children for a study of pediatric use of Ketek. The "pause" followed reports of four cases of serious liver damage in adults using the drug.

Bro said that the FDA-required labeling identifies the risks and that "we are currently looking at whether new data merits additional warnings."

Grassley has emerged in the past two years as a harsh critic of the FDA, which he accuses of being too close to the drug industry. As chairman of the Senate Finance Committee, which oversees Medicare and Medicaid payments, he called a high-profile hearing in 2004 into the FDA's handling of the withdrawn painkiller Vioxx, and yesterday he said he is contemplating calling another regarding Ketek.

"I'm tired of the runaround," he said after leaving the HHS headquarters. He said that he told the agencies' officials that "I know it's probably not your intent to protect companies, to cover for companies."

"But I said that every time that you stand in the way of information getting out that ought to be public, that's the impression you give the American people."

Posted by MBVIC at 12:52 PM | Permalink