The UNITED STATES FOOD and DRUG ADMINISTRATION

How many times have you read about the FDA (Food and Drug Administration)?  Are you sure as to what “they” can and can’t do?            

Most recently, in the news, some drugs were totally recalled because there were small particles of glass contained in them. (CNN.com, Cholesterol drug recalled over glass concerns,  http://edition.cnn.com/2012/11/25/health/statin-recall/index.html?hpt=hp_bn1&imw=Y)  Lifesavers, huh?  These drugs will not be placed back on the market until they are able to meet U.S. standards.

The FDA makes shopping feel wonderful.  You just browse and buy because you know deep down that if it is on the shelf, then it is OK.  Also, if it isn’t OK then you will surely find somebody liable.  In comes the FDA. (http://www.fda.gov/)

The FDA is a member of the executive branch of the government.  The FDA is in place in order to protect and promote public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs/medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, and veterinary products; in turn enforcing, Section 361 of the Public Health Service Act and associated regulations.  Many of these laws are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products.  This could include certain household pets to sperm donation for assisted reproduction.

The FDA is the feds.  You know, black Lincolns, and blacked out Surburbans, etc.   The FDA also works globally.  “Why?”, you may ask.  Sabias que, food and drug must assure that U.S. public health protection is maintained while still constructing more on an international scale.

Their annual budget is about 5 billion dollars.  The FDA serves underneath the Department of Health And Human Services. 

“Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs. Harvey Washington Wiley, Chief Chemist of the Bureau of Chemistry in the Department of Agriculture, had been the driving force behind this law and headed its enforcement in the early years, providing basic elements of protection that consumers had never known before that time.” (http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm)

The FDA helps with:

FOOD:

a.       Keeping holiday leftovers edible.

b.      Information on contaminated food in weather emergencies.

c.       Maintaining our knowledge of foodborne illnesses.

d.      Adhereing to food safety with new programs like FSMA.

VACCINES, BLOOD, AND BIOLOGICS

a.       Provides information on the shelf life of biologics.

b.      Updating influenza vaccines for this season.

c.       Core blood banking.

d.      Progress with vaccine testing.

ANIMAL and VETERINARY

a.       Food Safety and Modernization Act regulations.

b.      Taking care of pets in environmental emergencies.

c.       Aquaculture drug basics.

d.      Drug compliance for pet medicines.

COSMETICS

a.       Eye cosmetic safety.

b.      Nail care products.

c.       VCRP.

RADIATION-EMITTING PRODUCTS

a.       Mammography Quality Standards Act.

b.      Medical imaging safety.

c.       Providing information for Benefit-risk Determinations.

d.      Radiological Health Programs.

TOBACCO PRODUCTS

a.       Betobaccofree.gov launch.

b.      Spanish language community.

c.       Great American Smokeout.

You have read about the FDA more times than you can think of.  You didn’t know you were reading about them when you were reading about them, and they knew you were reading about them.  Read about them.

You might think, “It is interesting.”  This thought crosses your mind as you crunch open a 5-hour-energy.

Windows 8. Seems like Windows 7 just came out, yesterday.

“Microsoft bills Windows 8 as a “re-imagining” of the personal computer market’s dominant operating system”, (Poll: Scant demand for Microsoft’s Windows 8, http://www.azcentral.com/news/free/20121028microsoft-windows-8-poll-scant-demand.html

Michael Liedtke, AP Technology Writer , Sun Oct 28, 2012 12:44 PM).

                “Re-imagining” is one of those words that sound like it has never been used before.  So, what would be the term for imagining a subject approximately three or more times?  Also, it sounds a lot like AT&T with their “rethink” term usage.

                In the survey lead by Liedtke, it is apparent that a very high percentage of individuals don’t want to upgrade, yet.  What good reasons are there to upgrade?

Upgrade worries:

1.       A virus submissioned your harddrive.  Some known viruses were Stuxnet, Ram nit, Webmoner, and several other types of viruses which were all tough to eradicate.

2.       Your laptop is old and ugly.

3.       The speed is gone.

4.       The number 8 is your lucky number.

5.       You’ve upgraded everything else, already.

According to Microsoft, the best reasons to upgrade to Windows 8 include (http://windows.microsoft.com/en-US/windows-8/meet):

1.       Start screen sliding tiles.

2.       Picture password.

3.       The Surface.

4.       Swipe and snap multitasking.

5.       Streamlined apps from the Windows Store.

                The price, $39.99, isn’t that bad for the upgrade to Windows 8 Pro.  Keep in mind that this deal is only good from October 26, 2012 until January 31, 2013.  The pack is limited to five upgrade licenses per customer.  The price, as small as it is, must still offer help from Windows 7.  Not too many people complained about Windows 7.  My laptop still has the Windows 7 sticker on it.

What would be a cool addition is a “share” button on everything.  Control + share; then, you get a wide array of avenues.  You know, make it faster and easier to get the file where it should be.

Just a month ago, the computer stores were offering devices with Windows 7 like it was the ultimate option.  Some people hadn’t even heard of Windows 8 until stores put the new ads out.  Those ads function as the Windows 8 advertisement.  Everybody knows about the upgrade package, now.

Go research Windows 8.  Is your wallpaper getting redundant?

Slow-n- Low: issue 2 volume 2 pg 3

Slow-n- Low: issue 2 volume 2 pg 2

Slow -n- Low: issue 2 volume 2

BIRTH CONTROL FOR MALES

How long has birth control been in existence?

Good question. 

     Birth control methods have been utilized for thousands of years. In our present times, many safe and effective methods are easily available to us. Trying to choose is not as difficult if you take the time to research and learn about each method.  Have you considered birth control for males?

     Experimental steps toward a male preventive has made leaps and bounds.

     Recently, “…JQ1  successfully inhibited the production of sperm in lab mice.” (http://news.yahoo.com/science-takes-major-step-towards-creating-male-birth-155039405.html)

     This experimental cancer drug, that was being tested on mice, can serve as a hormone-free contraceptive pill for human men.  What is great about the findings as opposed to others is that the effects of JQ₁, were also found to be reversible.

What about when you don’t want to be sterile? 

Say: reversibility. 

     The effects were reversed through the mice by stopping the daily dosages.  Their sperm levels returned to normal. They were then able to fertilize their female partners and produce healthy offspring.

     According to lead researcher, Dr. Martin Matzuk of the Baylor College of Medicine Houston, "We envision that our discoveries can be completely translated to men, providing a novel and efficacious strategy for a male contraceptive.”

     Before these recent research results there was the first time hopes for a reversible male birth control option. This was earlier this year when the Los Angeles Times reported on a gel.  The gel decreased men’s sperm counts with minimal side effects. That gel contained the hormones testosterone and Nesterone (a man-made progestin).  (http://www.huffingtonpost.com/2012/08/16/male-birth-control-jq1-sperm-count_n_1784361.html)

   In a study led by Dr. Martin Matzuk, director of the Center for Drug Discovery at Baylor, and Dr. James Bradner, assistant professor at Harvard Medical School, found that JQ1, inhibited the amount and quality of sperm produced by male mice. Their study was published in August of the journal Cell.  Matzuk stated that, “We found that the JQ1 molecule causes a contraceptive effect in males,”, and he agreed that, “If you stop the drug, there’s complete reversibility.”  (http://www.webpronews.com/male-birth-control-pill-molecule-identified-2012-08)

     JQ1, in the rodents, impacted spermatogenesis via direct inhibition of the testis-specific bromodomain protein, BRDT.

     JQ1 altered sperm production. The blood-testis barrier was breached.  No separation of the  blood vessels and the seminiferous tubules. The male mice in the study mated normally, but were sterile, as the amount and quality of their sperm was low. Small molecules such as JQ1 can be used in pills similar to those used for female contraceptives.

     Matzuk importantly stated, also, that “JQ1 is not the pill for men, because it also binds other members of the bromodomain family”.  The bromodomain member is, BRDT.

    

     Matzuk emphasized the point, “However, the data is proof of principle that BRDT is an excellent target for male contraception and provides us with useful information for future drug development.”

     Members of the BET (bromodomain and extra terminal motif) family of proteins have been shown to be chromatin-interacting regulators of transcription.  In a BRDT experiment, a mutation was generated in the testis-specific mammalian BET gene Brdt (bromodomain, testis-specific) which disrupted spermiogenesis and male sterility.  (http://www.ncbi.nlm.nih.gov/pubmed/22570411) 

     The experimental steps consisted of:

Germ cell separation

RNA purification and microarray analysis

Quantitative real-time PCR

Northern blot hybridization analysis

In situ hybridization

Immunoblot analysis

Immunofluorescence

Flag-BRDT pull down

Co-immunoprecipitation

     FYI:  The stages of sperm production are spermatocytogenesis, spermatidogenesism, and spermiogenesis. 

     During spermiogenesis, the spermatids begin to grow a tail, and develop a thickened mid-piece, where the mitochondria gather and form an axoneme. Spermatid DNA also undergoes packaging, becoming highly condensed. The DNA is packaged firstly with specific nuclear basic proteins, which are subsequently replaced with protamines during spermatid elongation. The resultant tightly packed chromatin is transcriptionally inactive. The Golgi apparatus surrounds the now condensed nucleus, becoming the acrosome. One of the centrioles of the cell elongates to become the tail of the sperm.  Maturation then takes place under the influence of testosterone, which removes the remaining unnecessary cytoplasm and organelles. The excess cytoplasm, known as residual bodies, is phagocytosed by surrounding Sertoli cells in the testes. The resulting spermatozoa are now mature but lack motility, rendering them sterile. The mature spermatozoa are released from the protective Sertoli cells into the lumen of the seminiferous tubule in a process called spermiation.  The non-motile spermatozoa are transported to the epididymis in testicular fluid secreted by the Sertoli cells with the aid of peristaltic contraction. While in the epididymis the spermatozoa gain motility and become capable of fertilization. However, transport of the mature spermatozoa through the remainder of the male reproductive system is achieved via muscle contraction rather than the spermatozoon's recently acquired motility.

     The BRDT role in spermiogenesis, is in chromatin remodeling.  This is one of the most dramatic chromatin remodeling processes. Indeed, during the postmeiotic maturation of male haploid germ cells, or spermiogenesis, histones are replaced by small basic proteins, which in mammals are transition proteins and protamines. (http://www.mendeley.com/research/role-histones-chromatin-remodelling-during-mammalian-spermiogenesis/)

    BRDT is similar to the RING3 protein family. It possesses 2 bromodomain motifs and a PEST sequence (a cluster of proline, glutamic acid, serine, and threonine residues), characteristic of proteins that undergo rapid intracellular degradation. The bromodomain is found in proteins that regulate transcription. Several transcript variants encoding multiple isoforms have been found for this gene.

     The protein encoded by this gene belongs to the BET protein family. BET proteins have two N-terminal bromodomains and one C-terminal extraterminal domain (ET domain). BET proteins regulate chromatin reorganization via binding to acetylated histones. This gene is thought to play a role in the transcriptional regulation of spermatogenesis. Although referred to as testis-specific bromodomain (Brdt) protein, RT-PCR indicates that this gene is expressed in both mouse oocytes and testes. Alternative splicing results in multiple transcript variants encoding different proteins.

     So, controlling our reproduction is part of being human with intelligence.  We have been participating for quite some time.

     Don’t ask how long.

     To find your options for birth control, you can check at your friendly neighborhood CVS, or Walgreens.  Research online, too. 

     As far as birth control for males, it is in the process of being discovered.  This has to be perfected.  JQ1 is great and gives the reversibility of its potent effects.  Just stop taking the pill. Boom!  Loaded, and lethal!  BRDT is front runner.  This is where the future in drug development is for male contraception.

 

UNLIMITED VACATION TIME

It is time for us all to take a vacation together.  The beaches are beautiful this time of the year.  Remember our last vacation?  Let’s go! 

Yes, we are going on a vacation.  So, you can be the next to come to the office in a full body tan.  Like, “Sanket Naik took a six-week trip last year to Thailand and India to see his family, but he didn’t…”

How many days off at your job are available to you?  Why are you even keeping count?

Have you heard about the new trend?   …in the office. 

Well, think about your PRECIOUS allotted vacation time.  Go ask your boss.  You need to plan ahead of time in order to take some days off from work.  You have to ask yourself several quick questions that pertain to the smart use of your “unwell time”.  Will you need it, or won’t you need it? 

Wow, just imagine… Thoughts of summer vacations inspire visions of roasting marshmallows, tasteless T-shirts, and campfire sing-alongs.   LOL.  Remember Pamela Voorhees (Palmer) and her son at Crystal Lake. (http://m.complex.com/pop-culture/2012/06/the-25-best-summer-vacation-movies/friday-the-13th)

Corporate settings are adopting the notion to give employees unlimited days off.  Flexibility.  Keeping count of your sick days is an old concept.  Welcome to the world of “unlimited”.  Now, you can take you bike for a spin, take your girl out to Starbuck’s, and get her really wired up.

Unlimited vacation days at any job could change work output, no matter what a job consists of.  Think again.

Naik, senior director of cloud operations at Coupa said, “There’s the flexibility to travel or fulfill personal commitments without violating HR policies.  Coupa is one of a handful of companies, including The Ladders and Netflix, which have decided to offer the perk to employees.  Being a member of the unlimited vacation plan, you will still be held accountable for you responsibilities.  Angela Romano Kuo, vice president of human resources for the company. “Our salaried employees aren’t given a bank of vacation days; they take what they need,” she said. “If there’s a long weekend or a longer vacation that they want to take, they simply need to get their manager’s approval for the specific time off. Managers will ask the requesting employee for a plan of what will happen to his or her work during the absence, and if they’re confident that the workload will be covered, the request is approved, which it almost always is.”In the end, she said, “Our employees are responsible for the quality of their work, responsible for the hours they work, so they should also be responsible for the amount of vacation time they use.” (http://lifeinc.today.msnbc.msn.com/_news/2012/07/19/12813563-latest-work-perk-unlimited-vacations?lite)

1.  Your vacation time is unlimited.

2.  Write it all off.

The trip is primarily for business purposes.  Those few days of pleasure will stay in Vegas; deducted it. Safe!

Unlimited vacation time should be at every job.  Mobility is normal.  With laptops, phones, and other devices the office is anywhere you want it to be.

“What Is Considered Tax Deductible?”

Tax deductible: airfare, lodging such as hotel stays, meals, entertainment, conferences, seminars, workshops, etc.  Let me reiterate, be sure to include transportation costs: airfare, train tickets, car rental, taxi rides, personal car, mileage at 50 cents a mile, etc.  Lodging costs, too. (http://blog.turbotax.intuit.com/2010/06/08/vacation-deduction/)

So, it is time for us all to take a vacation together.  The beaches are always beautiful at this time of the year.  Last year your vacation was awesome.    

Vacation time might still be precious to you, though. Just put it away, keep it hidden, and never speak of it.  No one knows, do they?