Dr. Edmund Clement Tramont (born 1939)
Date - Unknown (est. 1980s)
Wikipedia NONE
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Name
Edmund Clement Tramont
Birth
Aug 1939
Residence
1975-2020 Rockville, Maryland, USA
https://www.army.mil/article/88854/army_to_honor_doctor_for_fighting_deadly_viruses
2012-10-10-usa-army-news-service-army-mil-article-honoring-doctor-edmund-c-tramont.pdf
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WASHINGTON (Army News Service, Oct. 10, 2012) -- A retired Army doctor who helped develop vaccines to protect troops from meningitis, AIDS, hepatitis, diarrhea, and many other infectious diseases, will be among civilians saluted Thursday.
"His lifetime of dedication to military medicine has resulted in ... dramatic, positive impacts on the resiliency and readiness of our Soldiers," reads an excerpt from the Outstanding Civilian Service Award, which will be presented to Dr. Edmund C. Tramont.
Army Chief of Staff Gen. Ray Odierno will recognize Tramont during a Twilight Tattoo at Joint Base Myer-Henderson Hall, Va.
Tramont graduated from Boston University School of Medicine in 1966 and two years later he entered the Army, where his military medical career began. During his 23 years of active Army service, he compiled achievements including establishing infectious disease clinical and research programs at Walter Reed Army Medical Center and Walter Reed Institute of Research in 1970.
He also developed policies concerning HIV/AIDS in 1986 -- a new and unknown disease at that time -- which were compassionate toward those infected, while they also maintained force health protection and readiness. Those forward-looking policies remain in force today and have been a blueprint for civilian policies.
"Infectious diseases have always been a big issue for the military and at the time the military had no programs," he said. "I established the Army's first clinical infectious disease training program and the Air Force and Navy soon followed (our lead). I happened to be at the right place at the right time."
"On the research front, the Army has always emphasized prevention of diseases for force health protection and readiness and in that context, the Army has been directly or indirectly involved in the research and development of more vaccines than any other organization in the world -- over 30 presently licensed vaccines," he said.
Also while in the Army, he helped develop the Meningococcal vaccine. That vaccine protects against Neisseria meningitidis, a bacterium that causes meningitis, meningococcemia, septicemia, and sometimes septic arthritis, carditis and pneumonia, and can especially be a threat in basic training. He also designed and implemented vaccine trials for gonorrhea, shigella and HIV and participated in the development of the Adenovirus and Hepatitis B vaccines. Shigella can cause severe dysentery, is spread by flies and is of particular threat to troops in combat.
Besides doing research on infectious diseases in the Army, he also cared for patients. In fact, as a medical resident in 1968, he helped care for the ailing former President Dwight D. Eisenhower who was dying of heart disease.
"Despite being bedridden, (Eisenhower) was lucid and we talked about everything from golf and war to politics and life in general," he said. "I wish I were older and wiser then because I did not have a sufficient base of knowledge to appreciate all he had to say. If I could go back, I'd have a lot of questions to ask him."
After retiring from the Army in 1991, Tramont was recruited by the University of Maryland to restructure its Medical Biotechnology Center along lines similar to the the Walter Reed Army Institute of Research. While there, he established the Institute of Human Virology.
In 2001, he became director of the AIDS Division of the National Institutes of Health's Institute of Allergy and Infectious Diseases. During his tenure there, he helped lay the groundwork for the Army's collaborative efforts with NIH to produce vaccines that protect Soldiers and others from the infections indigenous to the tropics such as the Ebola, Marburg and Dengue viruses.
Tramont called NIH's collaboration with the Army and other services "manna from heaven," explaining that "NIH does the best basic or discovery research in the world, but is not organized to do the necessary field work and clinical trials in the developing world to determine the efficacy of those vaccines in the field."
"On the other hand, the military's medical research is oriented toward making products, or the development portion of the research and development process," he explained.
"They have labs set up on every continent except Antarctica and can do the kinds of field work and testing necessary for the vaccine and drugs against pathogens indigenous to that part of the world," he said. "In addition, the Army has military medical partnerships with other countries to provide surveillance on diseases in those remote areas of the world that could pose a threat to future military operations. And, the results are helpful to all of mankind. For example, the clean water we take for granted in the USA was spawned by efforts to protect troops against diarreheal diseases during our Civil War."
Tramont cited the Army's recent work in Uganda to find a vaccine for the Ebola virus and with Thailand for HIV and Dengue.
He said the Army -- in collaboration with NIH, the Centers for Disease Control and Prevention, universities and pharmaceutical companies -- is involved in the research and development of "more vaccines than any other organization in the world."
Because of ordinary stresses on young persons in the military, they have greater risk for getting sexually transmitted diseases, he said.
"Soldiers are two to three time more likely to get STIs (sexually transmitted infections) than their civilian counterparts in peacetime and as high as 50 times greater during wartime deployments," he said. "They're young, often serving in faraway places, lonely and under great stress."
For example, he said the incidence of gonorrhea among U.S. troops during World War II hampered their ability to take the Italian town of Anzio.
"This phenomenon isn't something new," he explained. "It's gone on since military history was first recorded."
Besides STIs, Soldiers have encountered a host of deadly viruses. During the Revolutionary War, the Continental Army lost the battle for Quebec in part because the Americans from rural areas were less immune to the smallpox virus than were the British from urban areas and were forced to withdraw due to the greater incidence of the illness, he said. On the other hand, he continued, the U.S. Army's campaigns against the Indians were made easier because the Indians were even more susceptible to the smallpox virus than were the Soldiers.
At the start of World War II in the Pacific theater, about a third of U.S. Soldiers were at one point unable to fight because of malaria, dengue fever and diarrhea, he said.
In the European/North African Theater, on the other hand, many Germans soldiers succumbed to shigellosis, a type of bacillary dysentery, contributing to their loss at the battle of el Alamein, which many military historians conclude turned the tide in favor of the Allies.
Tramont is certain that the Army's continued involvement in vaccination work will pay big dividends in the coming years as new, often deadly microbes emerge.
He explained the threat.
"There are more bacteria living in your gut than there are people on this Earth. Those bacteria have sex and they pass genes back and forth. Sooner or later, a previously susceptible microbe like gonorrhea will pick up genes, which will allow it to be resistant to antibiotics.
"Every single microbe, when it's exposed enough to antibiotics, will become resistant to antibiotics over time," he continued. "For example, penicillin was very effective against most pathogens when it was discovered 75 years ago, but today, except for syphilis, can not be counted on to be effective. That's natural evolution. The microbe evolves to become resistant and takes over. Today we face resistant microorganisms causing wound infections in our troops wounded in Afghanistan and Iraq and we don't yet have the reliable antimicrobials to treat them."
Tramont doesn't predict another bubonic plague or "Black Death" that killed an estimated 100 million in Europe and Asia in the mid-14th century. Rather, he thinks the next deadly worldwide infectious disease will be a respiratory virus, such as pandemic influenza or SARS.
However, he said the NIH and others are making great strides in producing a universal influenza vaccine. He said there's already a vaccine for Hepatitis B and HPV significantly reducing the incidenc of liver and cervical cancer caused by those microbes and the Holy Grail is finding a vaccine for other cancers.
"It could happen in my lifetime," he said with a note of caution mixed with optimism.
As to being presented a Lifetime Achievement Award by Odierno, Tramont said it was "quite a surprise" and that he feels "humbled and honored."
The award recognizes Tramont "as a true ambassador for Army medicine. (His) efforts to establish important medical research have resulted in life-saving breakthroughs in medical training and biomedical research."
As the associate director for Special Projects, he is responsible for establishing collaborations between NIAID/NIH and the military for militarily-relevant infectious diseases. Tramont said he will continue that work at the NIH with great zeal and passion.
(Editor's note: Others who will be honored at the Twilight Tattoo, beginning at 5 p.m., Thursday, on Whipple Field are: David Feherty, co-founder of Feherty's Troops First Foundation; Mike Conklin, with the Sentinels of Freedom; Bonnie Carroll, president of the Tragedy Assistance Program, known as TAPS; and Steve Dunning, co-director of NBC Universal's Veterans Network and a member of the Got Your 6 Campaign Steering Committee.)
2005 (Dec 26) - Who will make the HIV vaccines?
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1990 (Oct 21)
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2004
https://www.cbsnews.com/news/govt-md-doctored-aids-drug-study/
2004-12-13-cbsnews-com-goverment-md-doctored-aids-drug-study.pdf
Gov't MD Doctored AIDS Drug Study
DECEMBER 13, 2004 / 4:17 PM / CBS/AP
The government's chief of AIDS research rewrote a safety report on a U.S.-funded drug study to change its conclusions and delete negative information. Later, he ordered the research resumed over the objections of his staff, documents show.
Dr. Edmund Tramont, chief of the National Institutes of Health's AIDS Division, took responsibility for both decisions. He cited his four decades of medical experience and argued that Africans in the midst of an AIDS crisis deserved some leniency in meeting U.S. safety standards, according to interviews and documents obtained by The Associated Press.
Tramont's staff, including his top deputy, had urged more scrutiny of the Uganda research site to ensure it overcame record-keeping problems, violations of federal patient safety safeguards and other issues that forced a 15-month halt to the research into using nevirapine to prevent African babies from getting AIDS from their mothers.
The Associated Press reported Monday that NIH knew about the problems in early 2002 but did not tell the White House before President Bush launched a plan that summer to spread nevirapine throughout Africa. Now, officials have new concerns the drug may cause long-term resistance in the hundreds of thousands of African patients who received it, foreclosing future treatment options.
"I am not convinced that the site is indeed prepared to become active," Dr. Jonathan Fishbein, an expert NIH hired to improve the agency's research practices, wrote Tramont in July 2003.
Fishbein contended he should be given time to review Uganda's capabilities and safety monitoring before letting the site reopen, or NIH would risk being "toothless" in its new efforts to clean up sloppy research practices. He added that professional safety monitors hired by NIH had reservations about the site.
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In 2002, less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Health and Human Services Department sent a nine-page letter to Ugandan officials identifying violations of federal patient protection rules by NIH's research.
The NIH research "may have represented a failure to minimize risk to the subjects," the Office of Human Research Protections told Ugandan authorities in summer 2002.
Africa accounts for more than two-thirds of the world's AIDS cases, with 27 million infected, and the United States sought to help slow the disease's spread across the continent.
Tramont dismissed the safety monitors' concerns, saying he didn't believe they fully understood AIDS.
"I am convinced that this site is ready to resume given the limitations of doing research in any resource-poor, underdeveloped country," Tramont wrote July 8, 2003, in response to Fishbein.
"I want this restriction lifted ASAP because this site is now the best in Africa run by black Africans and everyone has worked so hard to get it right as evidence by the fact that their lab is now certified," he wrote.
NIH officials acknowledge Tramont rewrote the report and overruled his staff on the reopening, but said he did so because he was more experienced and had an "honest difference of opinion" with his safety experts. They noted he had no financial interest in nevirapine and that the troubled study began well before he joined NIH in 2001.
Those who raised objections "were part of a large team of which Dr. Tramont was the head, and it is important that the people involved in that team should express their opinion and there should be discussion," said Dr. H. Clifford Lane, the NIH's No. 2 infectious disease specialist and one of Tramont's bosses. NIH designated Lane to speak to AP on Tramont's behalf.
"But at the end of the day the final responsibility lies with the head of the team and it is his job to put that together the way he sees it," Lane said.
Lane said an internal NIH review concluded Tramont had not engaged in scientific misconduct. Separately, the National Academy of Sciences continues to investigate whether the Uganda research was valid.
NIH believes it helped save hundreds of thousands of African babies by allowing nevirapine to be used in single doses to block the AIDS virus, Lane said. But he acknowledged the research was imperfect, and NIH now believes nevirapine should no longer be a first choice for newborn protection — if other options exist — because of the newly discovered problems about resistance.
Tramont wrote in 2003 e-mails that he reopened the clinics because he didn't want NIH "perceived as bureaucratic but rather thoughtful and reasonable" and that it was important to encourage Africans' fight against AIDS "especially when the president is about to visit them."
Bush visited the continent a few days after Tramont ordered the clinics reopened.
Tramont's actions, however, drew a blunt reply from his top deputy.
"I think we are cutting off our noses to spite our face here," AIDS Division Deputy Director Jonathan Kagan wrote. "...We should not be motivated by political gains and it's dangerous for you, of all people, to be diminishing the value of our monitors."
Tramont prevailed and the research resumed. A few days later, Tramont sent a note to his staff ordering the end of an 18-month-long debate inside NIH over whether the science from the Uganda trials was valid and safe. That debate began in early 20002 when two audits divulged widespread problems with the research.
The Uganda trial "has been reviewed, re-monitored, debated and scrutinized. To do any more would be beyond reason. It is time to put it behind us and move on," Tramont wrote in a July 13, 2003 e-mail instructing his staff that future issues about the drug be handled directly by his office.
Five months earlier, Tramont surprised one of his own medical officers who had written a report summarizing safety concerns uncovered during a second review of the Uganda trial.
Dr. Betsy Smith's report, finished in January 2003, said the Uganda trial suffered from "incomplete or inadequate safety reporting" and that records on patients were "of poor quality and below expected standards of clinical research."
She strongly urged NIH not to make sweeping conclusions about nevirapine based on the Uganda research. "Safety conclusions from this trial should be very conservative," she wrote.
Behind the scenes, Tramont asked to see Smith's report before it was submitted to medical authorities, including the Food and Drug Administration. "I need to see the primary data — too much riding on this report," Tramont wrote Jan. 23, 2003.
A few weeks later, the safety report was published and sent to FDA without Smith's concerns and with a new conclusion.
The study "has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission," Tramont's version concluded. "Although discrepancies were found in the database and some unreported AEs (adverse reactions) were discovered ... these were not clinically important in determining the safety profile."
In disbelief, Tramont's staff began inquiring how Smith's report got changed. An answer came back from the top.
"I wrote it," Tramont responded.
Excerpts showing key differences between an original
safety report written by the National Institutes of Health's
Dr. Betsy Smith concerning research on the AIDS drug
nevirapine and the rewritten version of the report by
AIDS research chief Dr. Edmund Tramont.
Smith's original version:
"Acceptable or required timeframes for reporting SAEs
(severe adverse events) and deaths were not followed."
"The safety reporting quality for the HIVNET012 study does
not meet levels expected in prenatal trials sponsored by
DAIDS (NIH Division of AIDS)."
"The supervision or monitoring of the willing and capable
Ugandan site personnel in all aspects of safety, including
subject information regarding treatment risks,
verification of eligibility criteria for mothers and
infants as well as safety reporting does not appear to
have been in place and raises concerns about the study
conduct."
"Safety reporting did not follow DAIDS reporting
requirements during the conduct of HIVNET012. Safety
conclusions from this trial should be very conservative."
"Site records for safety monitoring and subject visits
were of poor quality and make safety statements very
difficult from the perspective of a review process."
"Monitoring during the trial for safety and clinical
trial management was not in evidence."
Tramont's final version:
"There was some concern expressed by one of the American
physician monitors about the adequacy of standards of
clinical care in Uganda."
"During the full review of 80 mother-infant charts, the
reporting of AEs (adverse events) was found to be
generally complete. The discrepancies that were found
between the database and the source documentation were
due to some missing information in the adverse event
report."
"The remonitoring of review process undertaken by the
safety review panel has shown that there was a
consistent attempt throughout the study to document
AEs and SAEs as evidenced by the large numbers of
such reports ... and the small numbers of missed events
in the remonitoring process."
"HIVNET 012 has demonstrated the safety of single dose
nevirapine for the prevention of maternal to child
transmission of HIV infections. Although discrepancies
were found in the database and some unreported AEs
were discovered during the remonitoring process, these
were not clinically important in determining the
safety profile."
First published on December 13, 2004 / 4:17 PM
© 2004 CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.