News Posts

Drug Importation is Dangerous – 4 Former FDA Commissioners Advise

According to the last four administrative FDA commissioners Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan, drug importation is a risky move despite the fact that Donald Trump and Bernie Sanders support it. This is a move that would pose great danger to consumers as the risk of exposing them to contaminated, fake or substandard drugs are high.

Two FDA in an open letter to congress raised these concerns. The letter was also posted in the Margolis center for Health Policy in Duke University. Four former FDA commissioners, two who served under the Obama regime and the other two who served under Bush signed the report.

The four commissioners acknowledged that while the move to import drugs would mean lowered medical cost especially with regard to drug access, it also meant that patients would be exposed to poor quality drugs. This would be compromising the carefully the safety standards that the country has spent so many years building. The commissioners believe that accepting to import drugs would translate to jeopardizing the health of the citizens.

According to Bernie in a motion to the senate, he claims that there should be a legislation allowing the US to import drugs from other countries preferably Canada and Europe. He claims that drugs from these countries are cheaper because of government regulations.

Even with this, the FDA commissioners in their letter warn that the global market experience has not been a good one. The availability of adulterated drugs, illegal and ineffective drugs is on the rise. In fact, this industry has become one of the most organized crimes. Accepting to import medication would mean exposing US citizens to such risks.

According to Callif, in a Friday interview, most of the online advertisers claiming to be based in Canada re actually located in South America, Russia and Eastern Europe. It is therefore impossible for consumers to know for sure what is in the drugs and where the drugs come from. In fact, there is a greater fear that consumers may never be sure if they getting what they ordered for.

Even with such legitimate concerns, supporters of drug importation brush off these safety limitations with the claim that they can be controlled. The supporters claim that the country’s drug industry is exaggerating the risks to thwart the idea of importation. Sanders claims that only FDA approved sellers will be contacted after the FDA has done a thorough investigation of the manufacturing plants.

 

Former Presidential Cabinet Assistant Named President of AAAS

Dr. Margaret Hamburg M.D. of the Parker Institute will become the new president of American Association for the Advancement of Science in February. As a board member for at Parker Institute, she dealt with Cancer Immunotherapy that is an individualized treatment for people who suffer from cancer. Dr. Hamburg has no intention of giving up her board member position at Parker Institute once she is sworn in as AAAS president. She will also continue as the foreign secretary of NAM.

Prior to her appointment as the new president of American Association for Advancement of Science, Dr. Margaret Hamburg served as commissioner for the Food and Drug Administration during the years 2009 to 2015. She assisted in the advancement of regulatory science and overseeing the production of various medical products, in addition to the implementation of laws to curb the use of tobacco and enhance food safety.

Before Dr. Hamburg worked at the Food and Drug Administration, she was the vice president and senior scientist at the Nuclear Threat Initiative. President Clinton gave Margaret Hamburg an assistant cabinet position in his administration. She served as the assistant to the secretary of U.S. Department of Health and Human Services. As an assistant, Hamburg helped with the planning and evaluation of the projects.

Cancer Immune therapy is not about giving people chemotherapy and radiation because that is the way to treat the tumors. Immune therapy studies recognize that everyone is an individual and their bodies respond a little differently than most people. Parker Institute is fighting to change the future by changing the way cancer patients are treated for this disease. Going along with the individuality of one’s bodily needs will allow the body to use its own defense mechanisms to fight off cancerous cells. The dense mechanism will begin to tell the difference between healthy cells and cancerous ones and kill off the harmful ones. The new breakthrough is the smarter way to treat cancer. Remission for the near future and until the body is cured of cancer is now possible. Today, many people who go into remission end up lapsing back as more cancerous cells start to grow. Margaret Hamburg is dedicated to the advancement of science and working towards the day when no matter what type of cancer a person has, they can be effectively treated with immunotherapy. Why would anyone want to use a cancer therapy that disagrees with the body?

 

Advance as a Consultant by Taking a Look at Yourself

While there was a time when many businesses only brought in a consultant when they were looking to expand to new operations or were facing some kind of crisis, now consultants are valued as some of the most important members of any staff. In this ever-changing technological world, the expertise of consultants is more prized than ever. It should come as no surprise, then, that more and more young professionals are considering a career in consulting.

Regardless of their experience, the one question that everyone has when they are trying to become a valued consultant is “How do you truly advance your career in this field?” Learning systems such as the renowned Associate Talent CAPCO program are a fantastic option for post-graduates looking to expand their financial consultation skill set and further their personal growth, but even excellent programs such as that must eventually end with the individual entering the business world where they must find a way to constantly advance their careers and themselves.

The very first thing that every consultant who wishes to get ahead needs to know is that the best consultants are never the ones that exhibit superiority. Though you may be hired for your knowledge, it is important that you develop a reputation for yourself as a team player that is able to integrate themselves into any environment and immediately contribute.

That being said, you also don’t want to become a generic individual that just fades into the background. As important as it is not to rock the boat as a consultant, that doesn’t mean that you can’t use your knowledge to really insert yourself into a situation and let everyone you work with know that you really are an expert. The key here is to make sure that you always present yourself as being open to communication and enjoyable to work with on a personal level, but you must avoid the desire to take control of every project.

Once you’ve built a rock-solid personal reputation, the next thing you will need to realize is that it is the nature of your position to bounce around between organizations. As such, it is vital to make sure you do tie your own success to the success of an individual business as much as possible and rather that you find opportunities that allow you to replicate that success at multiple places.

It may not be easy to advance within the consulting world, but you’ll find that the effort will most certainly pay off in this highly rewarding field.

FDA Bans Dangerous Trans Fats in 2018

The Food and Drug Administration (FDA) has placed a ban on synthetically produced trans fats. The process of hydrogenation is used in the production of these fats that are now labeled dangerous. The FDA has given food manufacturers three years to find substitutes for these now dangerous food products, as advised under former FDA Commissioner Margaret Hamburg.

For decades many people considered all fats as dangerous and their consumption would add pounds to the body and damage to the internal organs. Vegetarians who consumed dairy and egg products received limited fat intake, while Vegans only received healthy fats from vegetables. While many advocates of vegetarianism were popular during the second half of the 20th Century, the doctors and the AMA stood opposed. One doctor, Dr. Atkins revolutionized diet programs with his heavy in fat and zero carbohydrate diet, which became popular. Proponents were proving the good effects of the diet. But most on the diet regained much if not all the weight that they had lost while dieting when they stopped the diet.

Another dietary system has proven to be effective, that advocating organic fruits and vegetable and not using any of the packaged food products popular today. These proponents had it right by avoiding the now dangerous hydrogenated trans fats used to give packaged foods a longer shelf life.

Americans are dangerously overweight. Some risk early death, dementia, heart disease and stroke. It is a common concept held by many consumers that whatever is produced in food factories here in America is not dangerous, but the FDA actions have proven this attitude as dangerous to a person’s mindset and to their overall health as well. The latest and perhaps best method of eating correctly and healthily is to use only organically grown fruits and vegetables, limit milk and meat and avoid all packaged food products. This diet has now been proven valid by the findings of the Food and Drug Administration.

Scientists Will Announce “Doomsday Clock” Time

Scientists behind a “Doomsday Clock” that measures the likelihood of a global cataclysm are set to announce Tuesday whether civilization is any closer or farther from disaster.

The Bulletin of the Atomic Scientists is expected to unveil the minute hand on the metaphorical clock in Washington, D.C. The clock reflects how vulnerable the world is to catastrophe from nuclear weapons, climate change and new technologies, according to the bulletin.

California Gov. Jerry Brown will join former U.S. Secretary of State George Shultz and former U.S. Secretary of Defense William Perry for a discussion at Stanford University after the unveiling.

The scientists behind the bulletin adjusted the clock from five minutes-to-midnight to three minutes-to-midnight last year, citing climate change, modernization of nuclear weapons and outsized nuclear weapons arsenals as “extraordinary and undeniable threats to the continued existence of humanity.”

The minute hand is assessed each year. It has also previously stayed the same and been adjusted in the opposite direction. Most recently in 2010, bulletin scientists cited nuclear talks between the U.S. and Russia and agreement to limit a rise in global temperature for a change from five minutes-to-midnight to six minutes-to-midnight.

Full article found here: http://dfw.cbslocal.com/2016/01/26/scientists-to-announce-doomsday-clock-time/

Venture Capital Funding for Start-Ups: Why it Works for Business

Businesses around the country are getting a lot of money from CAPCO programs, and CAPCO programs are sending out money for people who are in desperate need of funding for their businesses. The funding that comes from CAPCO could be really low, or the funding could be really large. Each business gets to make a choice as to how much funding they need, and the businesses can send in as many applications as they want. Pestering someone for money is not exactly the strong suit for many business owners, but it is something that the CAPCO program does pretty well. The CAPCO program in every state has millions of dollars to spend, and nearly every application can be fulfilled.

The Money

The Money for CAPCO is given to the state for the purposes of helping businesses, and each business is going to be able to apply for a special need. The funding could help a startup get off the ground, or the funding could help get more employees in the office. Using just one person to get all the work done is never enough. New projects are not going to get anywhere if they have not been set up well, and the money from CAPCO can help get everything going.

Better Advice

The CAPCO program helps match people who need money with businesspeople who can offer good advice. Taking good advice from people in the industry is going to help a business perform better, and the business is going to perform magically because they are able to get someone to tell them what to do. That kind of advice helps businesses do better overall, and the money is going to go a lot farther because these companies are able to use that money to do just what is needed. The advice could come with the money specifically, or these companies could keep in touch with the people who offered the money.

The CAPCO program is bringing together businesses and venture capitalists who are in need of help finding new companies to invest in. This makes it easier for startups to do well, and it is going to make it simple for a company to apply for more money. Anyone who thinks that they do not have a way to get more money can still get the money they need with a simple application and a little time invested.

Why Recycling Polystyrene Foam is the Future

Foam Bans Won’t Work. Recycling Foam Will!

Foam products provide thousands of jobs directly and indirectly through value chain involved in their manufacturing. Polystyrene is usually manufactured from Styrene, a petroleum byproduct. Bio-chemical research indicates that approximately 5% of a foam product is manufactured from polystyrene, and the remainder being pure air. In order to recycle these products, they must be thoroughly cleaned before they can be processed. This is a resource intensive process that involves both time and money.

Polystyrene is very light and it is only responsible for 0.01 percent of the entire municipal solid waste stream by weight. However, the main problem with polystyrene is its volume and not the weight. This product consumes a lot of space in landfills and to make matters worse it does not biodegrade. The product is also very expensive to recycle afresh.

There have been several attempts for Polystyrene to be banned. However, polystyrene is still beneficial in one way or another. New York had their foam ban overturned and other cities contemplating a ban, like a Mississippi foam ban, have abandoned efforts to follow through.

Foam should be recycled because it lowers packaging costs on most businesses. Foam also provides versatility, and immediately the product has been recycled into small pellets, it becomes possible for businesses to use it for different purposes including insulation that directly conserves energy. It can also be used as building materials whereby recently polystyrene has been used to construct fencing poles, a good alternative compared to using steel or cutting down trees.

School districts in the south are already using recycled foam because foam trays are a cheaper alternative compared to popular alternatives, and the saved resources can be invested in crucial learning areas such as upgrading the library, or installing a more state of the art IT system.

In addition, since businesses such as restaurants and grocery stores rely on foam products, recycled polystyrene can be used to lower operating costs. These restaurants and grocery stores must always hygienically pack their foodstuff because every meal ordered means a foam product must be used in one way or another.

Foam is cost effective compared to other packaging materials available in the market. The product is two to three times cheaper and foam also acts as a superb insulator compared to other more expensive packaging materials.

It is therefore prudent that local authorities should find ways of encouraging polystyrene recycling rather than imposing a total ban on the products.

Recycling Polystyrene

  • There are various drop-off sites in Southeastern USA and if you are unsure of your nearest location you can consult with Earth911.com. It is advisable to call local sites before embarking on any deliveries so that you can acquaint yourself with the recycler’s terms and conditions prior to the process.
  • It is also possible to procure the services of a mail back program to return the foam product to the original manufacturer who will do the recycling on your behalf
  • The products can also be donated to logistic companies who are ready to reuse the materials when doing the shipping

Polystyrene conservation initiative starts with you and me, and this is why we the product users must prove to the government that we can responsibly take care of it by following sound disposal process.

Sprout Pharmaceuticals Is Close To Obtaining FDA Approval On The First Drug Available For Women Suffering HSDD

The FDA (Food and Drug Administration) met jointly with the Bone, Reproductive and Urologic Drugs Advisory Committee and also the Drug Safety and Risk Management Advisory Committee to decide with an eighteen to six vote that Sprouts Pharmaceuticals ADDYI meets approval of FDA guidelines with their Hypoactive Sexual Desire Disorder (HSDD) for women in premenopausal. A stipulation was set stating only if certain options for risk management apart from labeling are used.

Sprout Pharmaceuticals is very excited about this outcome. They are now one step closer to being able to get their product out to the public for one of the most common female sexual dysfunctions. HSDD is a sexual dysfunction in women that has been recognized by the medical community for over 40 years. This disorder is defined as having a lack of desire for sexual activity. This results in the decline of women’s personal relationships. There are approximately one in three women who suffer from HSDD in the United States and one in ten who are distressed by its affects.

ADDYI is one of the most studied health products in history. This medication continued to demonstrate significant results over placebo tests on three key points.
* Increase in sexual desire
* Decrease in distress as the sexual desire returned
* Increase in the frequency of satisfying sexual activity
The improvements were seen in as little as four weeks and were maintained over the 24 week treatment time. The women included in the testing, agreed themselves that the improvements they experienced were meaningful to them.

ADDYI was tested in clinical trials in over 8,500 patients. Of the 8,500 patients, 1,000 of them used the treatment for about a year. The safety profile it created was favorable. The side effects experienced in some of the test patients included; sleepiness, nausea and dizziness. The FDA is still not required to accept ADDYI and apply their approval to it even though the joint meeting did end in favorable results. They are still considering this new drug and if approved it will be the first on the market with FDA approval for HSDD.

ADDYI is designed to help restore prefrontal cortex control. This is the part of the brain that controls motivation and reward structures. This is the part of the brain where sexual desire manifests. It is to re-balance neurotransmitters influencing sexual desire and increase dopamine and norepinephrine. These are both responsible for sexual excitement. Sprout Pharmaceuticals will continue to seek FDA approval for ADDYI as there currently is no medicine on the market to help women with this disorder.