Scholar, Scientist, Physician, Public Servant

Margaret A. Hamburg is a graduate of Radcliff College and received a medical degree from Harvard Medical School. Her research was in neuroscience at Rockefeller University in New York, and she studied neuropharmacology at the National Institute of Mental Health in Bethesda, Maryland.

Dr. Hamburg was raised by prominent physicians. Her friends were related to the medical profession. Her expertise is in community health. She is also an expert in a field not usually associated with the medical profession in the areas of biodefense, and preparedness for nuclear, biological, and chemical threats.

Because of Dr. Hamburg’s expertise in appreciating the danger of these threats, she supported a foundation devoted to public safety, the Nuclear Threat Initiative, which appointed her as the vice president for biological programs.

Dr. Hamburg has focused on AIDS research, serving as the assistant director of the National Institute of Allergy and Infectious Diseases), from 1989 to 1990. Further, she has been associated with the U.S. Office of Disease Prevention and Health Promotion.

From 1991 to 1997, Dr. Hamburg served as health commissioner for New York City. She developed cutting-edge programs for containing the proliferation of tuberculosis and AIDS. The TB rate fell by 86 percent for the most resistant strains.

In 1997, she was appointed by President Clinton to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services. In 2009, President Obama appointed Dr. Hamburg as the commissioner of the U.S. Food and Drug Administration.

Dr. Hamburg is a member of the board of the Parker Institute for Cancer Immunotherapy. She has been heralded to have a wealth of experience in science, health care, and regulatory affairs.

The Parker Institute has forged a collaborative relationship with outstanding scientists, clinicians, and industry. The Parker Institute coordinates the cancer immunotherapy research effort. Its primary goal is the advancement of the understanding of immune therapies capable of curing cancer.

As a board member of the Parker Institute, Dr. Hamburg, in 2015, was appointed the foreign secretary of the National Academy of Medicine (NAM). Dr. Margaret Hamburg has now been named as the president-elect for the American Association for the Advancement of Science (AAAS). Her term will begin in February 2017.

On top of all this dedication to public service, Margaret Hamburg’s most precious accomplishment is a mother of two children, while she gave birth while employed as New York City Health Commissioner.

 

New Gene Therapy for Cancer Offers Hope

Dimas Padilla thought he was dying for sure.

He’d been through the wringer with a type of blood cancer called non-Hodgkin’s lymphoma. First, he tried chemotherapy, and then, when the cancer came back a year and a half later, he underwent a bone marrow transplant.

But last year, when it came back again, he believed he was out of options.

“I was losing my battle against cancer,” Padilla, a 43-year-old sales representative, told NBC News.

Then he found out about an experimental therapy that’s a step beyond bone marrow transplants.

Called chimeric antigen receptor T-cell therapy — CAR-T for short — it involves taking a samples of T-immune cells called T-cells from a patient, genetically engineering them, and putting them back in to fight the cancer.

Continue to the original article

Source: nbcnews.com

Former FDA Commissioners Oppose Importation Of Prescription Drugs

An article in The Washington Post, dated March 17, 2017, describes the effort to legalize the importation of drugs from other countries into the United States. Its headline points out that the four recent commissioners of the Food and Drug Administration (FDA) have come out in opposition to this effort. The thrust of their objections center around the safety of prescription drugs that are not produced within the rules and regulations of the FDA.

The former commissioners are Robert Califf and Margaret Hamburg, both of whom hold this position while Barack Obama was President. They are supported by Andrew von Eschenbach and Andrew McClellan, whose time was during the administration of President George W. Bush. Their opposition to importation of drugs from outside the United States came to light in a letter to members of Congress. The letter was sent in response to legislation introduced to allow importation from licensed agencies in Canada, and perhaps later, from Europe.

The purpose of the letter was twofold. One was to inform members of Congress of the opinions of the former commissioners, and to encourage them to not support the legislation. The other purpose was to inform the public, and hopefully encourage the American people to contact their members of Congress, and urge them to not support this bill. The commissioners made clear their opposition to importation. The FDA regulates drugs in the United States, but has no way to regulate or guarantee the safety of drugs imported from other countries. The former commissioners consider this to be a public safety issue.

The impetus behind the legislation is the cost of prescription medicines. In other countries like Canada, the same drug is much less expensive than in the United States. Of course, that is the heart of the former commissioner’s objections. They say that there is no guarantee than the drug that purports to be the same is really the same. It is really a question of quality control, or lack thereof.

Backers of the legislation say that the safety concerns can be met with appropriate regulations, and that the drugs would only come from reputable sources. The former commissioners counter that such regulations would drive up the price of imported drugs, and thus cancel out any savings.

This argument which pits safety against lower prices is not likely to be settled by this letter, and will be one that will be continued to be debated in the future.

The UAE Makes Polio Eradication a Top Priority

Poliomyelitis, or infantile paralysis, is an infectious disease most often referred to as Polio. Polio mostly affects the leg muscles but can also occur in the muscles of the head, neck, and diaphragm. The disease was widely spread in Nigeria, Afghanistan, and Pakistan but it was estimated in August 2015 that polio cases are down 75% YTD in Pakistan. In Nigeria and Afghanistan however, the disease remains endemic.

The United Arab Emirates (UAE) has made the complete eradication of polio its mission. Since 2011, there has been a partnership between UAE and the Bill & Melinda Gates Foundation. Together they have been working on spreading awareness of the crippling disease internationally, fundraising resources to producing and distributing vaccines against polio.

In 2013, Sheikh Mohamed bin Zayed Al Nahyan and Bill Gates hosted the very first Global Vaccine Summit in Abu Dhabi. During the event, Bill Gates announced that polio eradication was close and very much an achievable goal. The event was attended by a representative from each of the polio-affected countries and a number of organizations such as the World Health Organization, the US Centers for Disease Control and Prevention, UNICEF and Rotary International – all part of the GPEI.

Over $100 million have been geared towards supporting the immunization process. In order to spread awareness of the undertaken action, a documentary was filmed that showcases the vaccination efforts of healthcare workers in Pakistan. The documentary is called Every Last Child and is produced by Image Nation Abu Dhabi.

The UAE/Pakistani assistance in the eradication of polio has produced amazing results. In May 2015, estimates show that over 86.6 million vaccination doses have been administered and more than 20.6 million children under the age of five have received vaccination and have been protected from the polio virus. In 2013, The United Arab Emirates have also contained the polio outbreak in Syria. In Nigeria there has not been a single case of polio since 2014, proving that a polio-free world can be achieved.

With only Pakistan and Afghanistan left the effort continues. In addition to working with the Gates Foundation, the UAE has also partnered with USAID and a number of nongovernmental organizations. These partnerships will continue the fight to eradicate the polio virus from Pakistan and Afghanistan by continuing to spread awareness worldwide and raise resources for vaccines.

The real cause behind drug shortages

Group Purchasing Organization’s (GPO’s) have been under attack from some in the medical device community that stand to benefit financially by hindering them. For more than ten years, through misinformation about GPO’s, this small group of medical professionals have behaved very unprofessionally by trying to blame every health care crisis, including medicine shortages, on GPO’s.

According to research by the U.S. Food and Drug Administration (FDA) and other government agencies, GPO’s are not responsible for drug shortages. Documented facts show that problems with production, quality control and difficulties with bringing new suppliers online is the reason for shortages. GPO’s work towards healthy competition in the market to relieve this situation, not make it worse as some would claim.

Contracts with GPO’s are voluntary, not forced, and hospitals are still entitled to purchase off contract if they choose. The savings, administration and business policies of GPO’s have been completely reviewed by the U.S. Government Accountability Office as well as nearly every hospital in the U.S. Apparently, Physicians Against Drug Shortages don’t have the experience needed to successfully manage a supply chain.

Phil Zwieg, the Director of Physicians Against Drug Shortages, has even tried to bully academics whose research puts GPO’s in a more positive light and force them to change their opinions. Zwieg has even gone so far as to try to have them punished by their universities if they don’t cooperate and recant. No, it isn’t any GPO responsible for drug shortages. The answer to that question can be found in those working against them.

Perhaps if Phil Zwieg and his supporters shifted their focus from trying to destroy GPO’s to one of cooperation instead, this problem of drug shortages would fade away. Or maybe not, but one thing is certain. For as long as politics and medicine are mixed, it’s the patient who is going to suffer the most.

Nail Polish: The New Date Rape Detector?

Nail polish is something that a lot of women enjoy wearing, especially when they can experiment with different colors, styles and designs. It makes us feel pretty, unique and most of all, shows off how awesome our nails look. But how much more would we love nail polish if it could save our lives? That’s what four students from North Carolina State University are hoping to do with Undercover Colors (https://twitter.com/undercovercolor?lang=en), a company they created while in school, to help women determine if their drink contains a date rape drug (https://news.engr.ncsu.edu/2015/10/more-than-a-nail-polish/).

The idea came out of a senior design project in their department at NC State. The four students, Tyler Confrey-Maloney, Stephen Gray, Ankesh Madan and Tasso Von Windheim, wanted something that could alert women that they were in danger without bringing attention to them if they were in a sensitive situation, such as with a guy at a bar or at a party. And they thought, instead of trying to create something new, how about using a product that women are already familiar with and transferring it into something that could potentially save their lives.

Undercover Colors nail polish stickers will serve as an early warning system to women to protect themselves and to be aware of their surroundings as all these young men know someone who has been sexually assaulted and wanted something that would prevent sexual assault from happening to anyone else. The nail polish itself will be clear and when dipped into a drink, will change color if the drink contains a drug such as Rohypnol. The hope is that this company will not only bring awareness to sexual assault, but also serve as a deterrent for predators who want to take advantage of women and see alcohol as a perfect vehicle to do just that. This nail polish will serve as a preventive measure and will turn women into survivors, not victims.

With the funding and worldwide recognition Undercover Colors has received, it is now a fully-formed company with seven employees. And it won’t be long until we’re seeing their polish on store shelves across the country—look for Undercover Colors nail polish stickers next year.

Trans-fat end in sight, thanks to FDA

The Food and Drug Administration has announced a new plan to require food manufacturers to phase out the use of artificial trans-fats. Trans-fats, or partially hydrogenated oils, are the result of an industrial process that adds hydrogen to vegetable oils to make them more stable. Foods cooked with trans-fats tend to have a longer shelf-life, which makes the process very attractive for food manufacturers. Unfortunately, trans-fats have a long standing association with an increased risk of heart disease. The ban has been long fought for and follows on the success of individual states enacting similar bans. New York passed a ban on trans-fats in 2007 and California passed a ban in 2011.

Before the ban, which former Commissioner Margaret Hamburg helped to put in place, the FDA allowed companies to report trace amounts of trans-fats (less than 0.5 of a gram) as having no trans-fats at all. The ban now requires foods to be completely trans-fat free after 2018. The ban only applies to artificial trans-fats; that is, oils that have undergone the industrial treatment process to stabilize them. Some foods, such as beef and dairy, contain small amounts of naturally occurring trans-fats and are not impacted by the ban.

While the FDA has already issued warnings for consumers to limit intake of trans-fatty foods, the new ban provides motivation for food manufacturers to find alternative cooking methods. Some manufacturers have already taken measures to remove trans-fats from their products; Crisco reformulated their products in 2007 to eliminate trans-fats entirely. The FDA estimates that nearly 80 percent of U.S. foods have already made the move to eliminate trans-fats.

In the end, consumers come out ahead in the battle against trans-fats. The dangers of trans-fats were not well known until achieving widespread popularity. Misinformation about the dangers of trans-fats has made it difficult for consumers to make healthy eating choices. The FDA ban helps spread correct information about the health risks of trans-fats as well as eliminating it from widespread use in consumer food production.

Ambrotose: Health Supplement Improves Focus in Gamers

With the competitive gaming scene growing at exponential rates, gamers are often looking for the next big thing in order to one-up their opponent. Intense matches, rather it be in League of Legends, World of Warcraft, Halo, Counter Strike or another competitive game, are often won with small shifts in the teamwork dynamic. Small communication errors and being caught out of position can quite literally win or lose a game for you in a matter of seconds.

Many competitive gamers rely on their tournament winnings in order to provide a steady financial income for their professional lives. As a result, Mannatech http://allaboutmannatech.com/ decided to step into the market with their product named Ambrotose. Ambrotose helps by increasing the amount of focus and attention a gamer is capable of producing during those long and strenuous gaming matches. Similarly, Ambrotose can aide in the memory centers of the brain and help gamers remember strategies and formulate plans in order to facilitate an attack.

Ambrotose is a highly sought after new health supplement that been put through the wringer in terms of scientific testing and clinical trials. Mannatech has conducted numerous double blind, placebo based studies that all reveal that the formula does indeed help cognitive function within the individual consuming it. Moreover, the product helps boost the immune system and produces a healthy internal ecosystem for better optimization of internal functions and nutrient distribution.

For aspiring gamers in this growing industry who are looking to get all the help they can get, Mannatech provides a product called MannaBOOM Slimsticks. These sticks are all-natural and are infused with a blend of nutrients designed to give you a competitive advantage during your games. When consumed, gamers will notice an increased focus, an ability to think more clearly and rationally, and an overall sense of well-being.

If you or someone you love is an avid gamer that needs to take their skills to the next level, Mannatech has the solution you need. Their scientific approach and attention to detail have been put to the test and has shown great performance in boosting cognitive ability and overall function. Never again will you get killed or lose a match due to biological issues like brain fog or being distracted during a critical moment during the match.