Three Acts of Kindness from Strangers

The other day was my lucky day. Three events of kindness from strangers made my day.

Every week, my wife( Macrine) and I attend physical therapy so that Macrine's improved her gait in walking and develop muscle flexibility to prevent more falling as a result of her PD. While waiting in the Physical therapy office for our turn, I started coughing because of an itchy throat. I usually carry with me Halls throat lozenges, but that day I forgot. To my surprise, an elderly lady( about my age ) offered me a lozenge, exactly the same brand that I like. I accepted it with out hesitation and give her a million thanks.

After the therapy session, Macrine decided we pass by the grocery store to buy Pastrami and Havarti cheese( our favorite sandwich filling) in the deli section of the Raley store. There was a long line so I hesitated for a few seconds to get a number. A young stranger saw me hesitating and without any hesitation, he got a number and gave it to us. He commented that the line is getting long and we need to get serve fast. I gave him a look of appreciation as he walk away. The guy is Caucasian and must be in his early 30's. I will probably not recognized his face the next time I see him. Any way thanks, young man!

The last act of kindness occurred also on our way to check out from the store. We have less than 20 items. A lady customer ahead of us, asked if we are in a hurry. I said yes, because I was getting hungry and my head was starting to ache. She ask if we want to go ahead of her. I said yes and give her a million thanks and an appreciative smile.



Have you ever experience a similar act of kindness from strangers before? The three act of kindness from complete strangers we will never forget. Will I experience this kindness if we reside in the Philippines. Probably not, specially in Manila or in Makati, but perhaps in the provinces, may be even in Marinduque. Filipinos are noted for cutting in line!

I have a Mild Food Poisoning Yesterday

Last night, I was vomiting, was nauseated, no appetite, and had stomach cramps. I vomited all the lunch ( fish and chips)that I have and was feeling slightly dizzy. After throwing up I felt better. I took a cup of tea and went to sleep. This morning, I feel better and am back to my normal activities( writing this post). I believe I know what caused my mild food poisoning experience. The other day, after our trip from the Casino, I took the Fish and Chips that I barely consumed ( my wife and I had another dish that we shared). I placed it the refrigerator as soon as we arrived, but forgot to eat it till the next day. I am lucky my food poisoning symptoms was mild. Because of this experience, I did a little internet search on this subject and here's what I learned.

"Food poisoning is a common, usually mild, but sometimes deadly illness. Typical symptoms include nausea, vomiting, abdominal cramping, and diarrhea that occur suddenly (within 48 hours) after consuming a contaminated food or drink. Depending on the contaminant, fever and chills, bloody stools, dehydration, and nervous system damage may follow. These symptoms may affect one person or a group of people who ate the same thing (called an outbreak).

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 1 in 6 people becomes sick from eating contaminated food. In 2001, the CDC estimated that food poisoning causes about 48 million illnesses, 128,000 hospitalizations, and up to 3,000 deaths each year.

Norovirus and salmonella are the most common infectious forms of food-borne illness. Salmonella causes the most deaths followed by Toxoplasma and Listeria. Worldwide, diarrheal illnesses are among the leading causes of death. Travelers to developing countries often encounter food poisoning in the form of traveler's diarrhea or "Montezuma's revenge." Additionally, there are possible new global threats to the world's food supply through terrorist actions using food toxins as weapons.

Increased virulence of known pathogens has caused deadly outbreaks such as the E. Coli STEC outbreak in Germany in 2011".

Reference: http://www.livestrong.com/article/81362-mild-poisoning-symptoms/#

Note: This week Northern California is on triple digits temperature. With this heat, viruses that cause food poisoning grow fast, so food may be easily contaminated. Just be careful, because food poisoning could be deadly.

Time for Some Inspirational Music-The Prayer

I have heard several versions of the Prayer, with Celine Dione, Charlotte Church, Susan Boyle etc...Bot this video of Charice Pempengco(1) with the Canadian Tenors(2) is I would say, one of the best rendition of these very popular piece of music. View it and let me know if you agree or disagree. Just in case you have not heard of Charice and the Canadian Tenors, a brief description is printed below.



(1)Charmaine Clarice Relucio Pempengco was born on May 10, 1992. She is popularly known by the mononym Charice. She is a Filipina singer who rose to popularity through YouTube. Dubbed by Oprah Winfrey as "the most talented girl in the world", she released her first international studio album Charice in 2010. The album entered the Billboard 200 at number-eight, making Charice the first Asian solo singer in history to land in the Top 10 of the Billboard 200 albums chart.

She released the single "Pyramid" which featured singer Iyaz. It is her most successful single to-date, charting within the top 40 in a number of countries, and debuting on The Oprah Winfrey Show where she sang live vocals. Crossing over to acting on television, she joined the cast of TV series Glee as Sunshine Corazon.[4] She has released a new lead single, "Before It Explodes", written by Bruno Mars, from her international sophomore studio album, Infinity. Her latest single "Louder" was written by Andy Thi Hy in 2011. In March 2012, she signed on to be one of the four judges of the Philippine version of The X Factor, which began to air on ABS-CBN in June. She was in the news recently for admitting she is a Lesbian.

(2)The Tenors (formerly known as The Canadian Tenors) are a vocal quartet (originally a vocal trio) consisting of Remigio Pereira, Victor Micallef, Fraser Walters, and Clifton Murray, with Murray replacing earlier member Jamie McKnight. They perform operatic pop music that is a mixture of classical and pop, featuring songs such as "The Prayer" and Panis Angelicus from the former genre, and Leonard Cohen's Hallelujah from the latter. The venues they have performed in include the Tel Aviv Opera House, and the Mandalay Bay Events Center in Las Vegas. They have also appeared on the 2009 Grey Cup broadcast and on CBC Television’s Holiday Festival of Ice.

Botanical Drugs versus Botanical Dietary Supplements

Do you know the differences between botanical drugs from botanical dietary Supplements? Please read on even if you know the answer.

There are only two botanical drugs approved by FDA as of today. Last January, FDA approved Fulyzaq, the first anti-diarrheal drug for HIV/AIDS patients. Fulyzaq (crofelemer) is only the second botanical drug approved by FDA. The drug is made from the sap of the Croton lechleri plant. It is indicated for the treatment of watery diarrhea due to the secretion of electrolytes and water in the HIV/AIDS patients gastrointestinal tract. FDA reported that a recent clinical trial of 374 HIV-positive patients established the safety and efficacy of the drug. In the study, nearly 18 percent subjects taking Fulyzaq twice daily experienced clinical improvements.

FDA approved the first botanical prescription drug, Veregen, in 2006. VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in patients 18 years and older. It is formulated as an ointment.
Approval of this first botanical drug came about two years after FDA issued a guidance for the submission of a New Drug Application (NDA) in 2004. Prior to my retirement from FDA, I was a member of a Committee that drafted this guidance.

Two important distinctions between botanical drugs versus supplements are product claims and designated uses. In some cases the formulations of botanical drugs and botanical dietary supplements can be similar, but labeling has to be different.

Moreever, a botanical drug can claim to treat, prevent, cure, mitigate or diagnose a disease, but a supplement cannot. Therefore in order to become a botanical drug, the manufacturer/marketer must obtain pre-market approval from FDA by submitting an IND application, and then move on to the extensive NDA process to confirm safety and efficacy.
(http://theintellectualmigrant.blogspot.com/2011/11/simplified-overview-of-new-drug.html)

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical (excluding tobacco), an amino acid, a concentrate, metabolite, constituent, extract, or combination of any of the above or a substance historically used by humans to supplement the diet.

Furthermore, it must also conform to the following criteria: intended for ingestion in pill, capsule, tablet, powder or liquid form, not represented for use as a conventional food or as the sole item of a meal or diet, and labeled as a "dietary supplement"

Based on the Dietary Supplement Health And Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, and not as drugs. Therefore, pharmaceutical companies are required to obtain FDA approval, which involves assessing the risks and benefits prior to their entry into the market, dietary supplements do not need to be pre-approved by FDA before they can enter the market. Thus approval of new botanical drugs is a slow and tedious process, whereas dietary supplements are freely available for the consumers.

In September 2012, a report said sales of herbal dietary supplements in the United States rose by 4.5 percent in 2011. That report estimated 2011's U.S. sales as US$5.3 billion, whereas sales of the two botanical drugs approved was poor and sluggish.

I hope more botanical drugs are approved by FDA in the future. Botanical drugs in general have less side effects compared to the synthetic drugs.

Bizarre and Exotic Foods of the Philippines

I would never call the balut bizarre or exotic, since I am a Filipino-American. But if you are not a Filipino, I will not blame you. I have eaten the balut more than a hundred times when I was growing up in the Philippines, numerous coconut-rice cakes, fried crickets, stuffed frogs, cow internal organs, blood pudding but not the coconut and mangrove worms and the chicken intestines.

Balut is very delicious and nutritious and consider a brain food. When I was a student at the University of the Philippines, I will buy 4 baluts and gorged on it before my final examination in Chemistry. I dare you to try one, if perchance you have the chance to visit the Philippines in the future. The segment in the video about the underground river in Palawan is informative. This is an excellent video series by Andrew Zimmern.

Have You Heard of Siquijor Island, Philippines?

While I was searching for Herbal Medicine in the Philippines, I accidentally found this video about the Healing Festival in the Island of Siquijor. Do you know where Siquijor is? Siquijor [siki'hor], is an island province of the Philippines located in the Central Visayas region. Its capital is the municipality also named Siquijor. To the northwest of Siquijor are Cebu and Negros, to the northeast is Bohol and to the south, across the Bohol Sea, is the island of Mindanao.



Siquijor is the third smallest province in the country, in terms of population as well as land area (after Camiguin and Batanes). For a time it was part of Negros Oriental. During my teenager years, it was still a part of Negros Oriental, but I have already heard that is an island for witchcraft, magic and the prowess of the local medicine men and women. My interest in Siquijor Island have always been in my mind since my teenager days. The following video is a must view if you are interested in healing and alternative medicines practices in the Philippines.



Thousands of tourists and visitors flocked to the mystical island of SIQUIJOR for the annual healing festival held at Bandilaan Mountain View Park. This province has become known worldwide as the center that promotes natural healing. Tree bark, roots, herbs, dirt, insects and other 'secret' ingredients are thrown into a large cauldron filled with coconut oil. It is believed that supernatural forces roam the earth and share their healing powers to those who seek their assistance. Some sorcerers concoct 'love potions' or make amulets that are know to make their owners invisible! The videographer have personally witnessed and videotaped four healings and cures right before his eyes.! Thank you, Mr. videographer for info@globalvideoprotv.com for this excellent and informative video.

It is one of a most amazing healing videos and alternative medicine in action that I have seen so far. I really find this video informative and interesting. The scenery, waterfalls, white beaches and the tropical plants in this video reminds me of my second home in the Philippines- Marinduque Island. I hope you enjoy the video as much as I did~

Herbal Medicine in the Philippines

Herbal Medicine in the Philippines is one of several scientific subjects also very closed to my heart. Thus in both of my undergraduate and graduate degrees, my minor subject was in natural products chemistry but my major subject was Analytical Chemistry. In FDA I was involved in the various committees promulgating requirements for the approval of botanical drugs.(http://pu.blish.us/article/585/a-brief-overview-of-new-drugs-development-in-the-united-states#).

As a tropical country the Philippines is a good and an abundant source of plants with medical benefits. Regulation of these products are under the guidance of the Philippines Department of Health (DOH).

The following are the ten Medicinal Plants in the Philippines endorsed by the Department of Health:

1. Akapulko (Cassia alata) a medicinal plant called "ringworm bush or schrub" and "acapulco" in English, this Philippine herbal medicine is used to treat tinea infections, insect bites, ringworms, eczema, scabies and itchiness.

2. Ampalaya (Momordica charantia) Common names include "bitter melon " or "bitter gourd " in English. This Philippine herbal medicine has been found to be effective in the treatment of diabetes (diabetes mellitus), hemofrhoids, coughs, burns and scalds, and being studied for anti-cancer properties.

3. Bawang (Allium sativum) Common name in english is "Garlic". Bawang is a used in Philippine herbal medicine to treat infection with antibacterial, antiinflammatory, anti-cancer and anti-hypertensive properties. It is widely used to reduce cholesterol level in blood.

4. Bayabas (Psidium guajava) - "Guava" in English. A Philippine herbal medicine used as antiseptic, anti-inflammatory, anti-spasmodic, antioxidant hepatoprotective, anti-allergy, antimicrobial, anti-plasmodial, anti-cough, antidiabetic, and antigenotoxic in folkloric medicine.

5. Lagundi (Vitex negundo) - known as "5-leaved chaste tree" in english is used in Philippine herbal medicine to treat cough, colds and fever. It is also used as a relief for asthma & pharyngitis, rheumatism, dyspepsia, boils, and diarrhea.

6. Niyog-niyogan (Quisqualis indica L.) - is a vine known as "Chinese honey suckle". This Philippine herbal medicine is used to eliminate intestinal parasites.

7. Sambong (Blumea balsamifera)- English name: "Ngai camphor or Blumea camphor" is a Philippine herbal medicine used to treat kidney stones, wounds and cuts, rheumatism, anti-diarrhea, anti spasms, colds and coughs and hypertension

8. Tsaang Gubat (Ehretia microphylla Lam.) - English :"Wild tea" is a Philippine herbal medicine taken as tea to treat skin allergies including eczema, scabies and itchiness wounds in child birth

9. Ulasimang Bato | Pansit-Pansitan (Peperomia pellucida) is a Phillipine herbal medicine known for its effectivity in treating arthritis and gout.

10.Yerba Buena (Clinopodium douglasii) - commonly known as Peppermint, is used in Philippine herbal medicine as analgesic to relive body aches and pain due to rheumatism and gout. It is also used to treat coughs, colds and insect bites

Types of herbal medicine

Medicinal plants can be used by anyone, for example as part of a salad, an herbal tea or supplement. Many herbalists, both professional and amateur, often grow or wildcraft their own herbs. Making your own herbal medicine preparation is not only fun, but can be cost-effective. In using the above mentioned herbal medicines, some may require some degree of skill, you have to use your own judgement if you decide to use one. Below is a list of general ways on how to prepare your own herbal medicine. The list is not all inclusive and you have to see individual articles for the herb you use so that you will know how to prepare them.

Herbal teas: There are two methods of making herbal teas, infusion and decoction. Infusion is steeping lighter parts of the plant (leaves, flowers, light stems) in boiled water for several minutes. Decoction is boiling tougher parts, such as roots or bark for a longer period of time. Herbal teas are often used as a home remedy, and as an alternative to tea and coffee.

As a general rule unless recommended by a herbalist, Prepare 1 teaspoon of dried herb for every 1 cup of water. Let it steep in boiling water for 10 to 20 minutes. Strain the herbs out and drink 3 to 4 times a day.

Herbal tinctures: Steeping a medicinal plant in alcohol extracts the alcohol-soluble principles into a liquid form that can be stored for long periods. Herbalists may mix several herbal tinctures to form an individualized prescription for each patient. Plant tinctures are also the basis for many homeopathic medicines.

To prepare your herbal tincture you will need:

8 ounces of finely cut dried herbs,
1 large glass jar that can hold 4 cups of liquid
2 cups of vodka

Instructions:: Put the dried herb into a large, glass jar and pour in equal amount of liquid, making sure the herbs are completely covered (this is very important). Store the jar in a cool, dark place for at least two weeks, preferably 4. Make sure to shake the mixture every day. When ready to use, filter the mixture using a cheesecloth bag, coffee filter, or fine cloth, capturing the tincture liquid below in another container. Store the tincture in clean, dark glass containers, out of the sun. If stored properly the tincture will be preserved for two or more years. Vinegar tinctures should be refrigerated.

Note: A drop of tincture is equal to 1 tsp of herb juice.

For Vinegar Tinctures, use 1 ounce of herb per 5 ounces of vinegar.

Fluid extracts: Fluid extracts are stronger than herbal tinctures, and can be made with alcohol or glycerin.

Herbal poultices: Poultices are a solid, vegetable fat based mixture used externally. They have the shortest life span of any herbal remedy and must be made fresh for every use.

Powdered herbs and tablets: Herbs that are dried and (sometimes) certain parts are separated out then diced to powder fine consistency. Powered matter can then be compressed or put in an empty pill coating to form a tablet

Herbal creams and ointments: An ointment usually is mixed with beeswax (or something similar) to make it more applicable to outside the body, such as on a cut or scrape.

Essential oils: Extraction of volatile liquid plant materials and other aromatic compounds from plants gives essential oils. These plant oils may be used internally in some forms of herbal medicine as well as in aromatherapy and generally for their perfume, although their medicinal use as a natural treatment (alternative medicine) has proved highly efficacious in the treatment of headache and muscle pain, joint pain and certain skin diseases

Herbal supplements: Herbal supplements tend to be commercial products in tablet or capsule form manufactured and marketed by the health food industry for sale in retail outlets to the general public, although there are some types that are sold only to healthcare practitioners for prescription. Herbal supplements are often standardized to contain stated levels of active phytochemicals. Some herbalists may not agree with the standardization of active ingredients, preferring instead to use the whole plant.

Source: www.medicalhealthguide.com/philippinesherbalmedicine.htm

FDA Approved New Drugs for the Mid-year, 2013

Last week, I posted a list of new drugs approved in 2012. Again, as an FDA retiree formerly involved in the approval of new drugs, I am still very interested on what is new in FDA drug development this year.

FDA has been very busy this year so far. One medical device and more than sixty new drugs had been approved in eighteen therapeutic areas already for this mid year. In 2002 the year I retired FDA approved more than 100 new drugs that year. By the end of 2013, I predict that another 60 new drugs will be approved.

As a diabetic, I am quite delighted that two new drugs for type 2 diabetes are approved. These new drugs will be expensive, but we the patients have an an alternative options if we desire and believe these new drugs will have more benefits than risks in the cure of our malady. Congratulations to FDA and its employees for a good year so far.

1. Cardiology/Vascular Diseases

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

2. Dermatology

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

3.Devices

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

4. Endocrinology

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

5. Family Medicine

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

6. Gastroenterology

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

7. Genetic Disease

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

8. Hematology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

9. Immunology

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

10. Infections and Infectious Diseases

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

11. Musculoskeletal

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

12. Nephrology

Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013
Neurology

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

13. Nutrition and Weight Loss

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Obstetrics/Gynecology (Women’s Health)

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

14. Oncology

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013


15. Pediatrics/Neonatology

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

16. Pharmacology/Toxicology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Pulmonary/Respiratory Diseases

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

17. Rheumatology

Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Trauma (Emergency, Injury, Surgery)

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

18. Urology

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

19. Vaccines

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Source: www.centerwatch.com

Unusual Spike in the Number of Page Views in my Four Blogs

The last couple of days, four of my blogs, http://lifeinus1960present.blogspot.com, http://theintellectualmigrant.blogspot.com, http://marinduqueawaitsyou.blogspot.com and http://marinduquemyislandparadise.blogspot.com showed an unusual spike in the number of page views. The average page view per day of the four blogs vary from 100 to 200 page views. In the last couple of days the page views jumped to about 1200 to 2500 page views per day. The audience came from Germany.

Should I worry about this or should I be happy about it. The spike in the page views did have a slight effect on my Adsense earnings. How how I wish it had more effect. It did not affect the neocounter in the number of visitors that day.

Is this spike in page views real or is it an artificial spike cause by a robot or malware in Germany. I hope someone could give me an explanation. If you are a blogger have you experience this incident? All my other six blogs were not affected by this spike, only the four sites I listed above.

Time for Some Meditative Music-Prayer of St Francis

There are numerous arrangements of the song, Prayer of St. Francis. The one below is by Ryan Cayabyab and is one of my favorite arrangement.



Prayer of St. Francis
Sebastian Temple

Verse 1:
Lord, Make me a channel of your peace.
Where there is hatred, let me bring your love.
Where there is injury, your pardon, Lord,
And where there's doubt, true faith in you.

Verse 2:
Lord,Make me a channel of your peace.
Where there's despair in life, let me bring hope.
Where there is darkness only light,
And where there's sadness ever joy.

Refrain:
Oh Master, grant that I may never seek
So much to be consoled as to console.
To be understood as to understand,
To be loved as to love with all my soul.

Verse 3:
Make me a channel of your peace.
It is in pardoning that we are pardoned;
In giving of ourselves that we receive,
And in dying that we're born to eternal life.

Dinah Katague's Pottery Projects

The following is an article about my oldest daughter hobby of "neriage" printed in the Contra Costa Times. Have you heard of the word "neriage"?

Walnut Creek artist says more to clay art than meets the eye By Janice De Jesus contracostatimes.com

Clay artist Dinah Katague, of Walnut Creek, displays some of bowls she has made at the Civic Arts. Eight years ago, Dinah Katague came to know her new Walnut Creek home at the same time she rediscovered a passion with clay art. The Civic Arts Education Clay Arts Guild she joined was her home away from home. "I didn't know anyone in the neighborhood so I thought, this is my time for myself," said Katague. "I thought it was a good way to meet new people."

While she dabbled in sculptures by hand in high school and using the pottery wheel in college, Katague took a long break from clay. But when she embraced the art again eight years ago, she took the art on full force, adopting a technique of staining clay with different colors, layering it and then throwing it all together. Called "neriage," the technique -- first used in ancient Egypt and perfected in early modern Japan -- has given Katague's bowls and vases new life. She and her fellow artists will be displaying work at a garden-themed Clay Arts Guild Spring Sale Friday through Sunday. The garden-art-themed show will feature several artists' work, including planters and wall pots with live plants as well as wall art, wind chimes, bird feeders and houses, fountains, garden sculpture and garden lights.

Pottery, sculpture and dinnerware will also be available, both hand built and wheel-thrown pieces. "I call it my hurricane effect," Katague said of the neriage technique. "I guess I'm in my 'chaos period.' " Still, it is a period where the artist said she feels the calmest. "I notice when I'm throwing clay on the wheel, it's much easier to get into that zone," she said. "I look forward to doing this Wednesdays and Sundays."

Earlier on in her pottery life, the second year she learned how to throw that perfect pot, she remembers sitting at the wheel during open studio feeling so new and inexperienced, she said. "I overworked my pot and one side collapsed," she said. "I was just really mentally and emotionally defeated. At that moment, I was wondering if this pottery thing was a good idea for a hobby. Then a really nice woman came over to me and said, 'Oh, we can fix that.' She proceeded to bend in the other sides to match, added a few little knobs of clay and the once 'destroyed' pot became a beautiful artistic bowl. She looked at me and said, 'Dinah, in art there are no mistakes, just artistic opportunities.' " Since then, Katague has tried to live life with that philosophy learned in pottery class.

The artist credits teacher Lynne Meade for introducing neriage to her work. "A while back I did a one-day demonstration of inlaid colored clay for Dinah's class," Meade said. "Since then she has taken the technique and made amazing progress with it. She's taken it to new places despite technical difficulties and challenges. "She has persevered with her vision even when it seemed too difficult, Meade added. "That, to me, is the mark of a good artist and a great student -- when you give them a tiny seed and they nurture it into a blossoming tree. As a teacher, it is what you hope for and wait for. When you see it, it's always gratifying."

I am proud of your accomplishments, my beloved daughter!

FDA approved New Drugs in 2012

As a retired FDA employee formerly involved in the approval of new drugs, approval of new drugs by the FDA is a subject still close to my heart. Last year ( 2012) had been a very busy year for FDA. More than 200 new drugs in 26 therapeutic areas were approved. The following is a list from www.centerwatch.com for your reading pleasure and information. Consult your physician, if you think one of these new drugs will have more benefits than risks ( side effects) in the treatment of your malady.

1.Cardiology/Vascular Diseases

Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism resulting from nonvalvular atrial fibrillation, Approved December 2012

Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial hypercholesterolemia, Approved December of 2012

Vascepa (icosapent ethyl); Amarin Pharmaceuticals; For the treatment of hypertriglyceridemia, Approved July of 2012

2. Dermatology

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

3. Endocrinology

Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012

Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved February 2012

Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012

Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s syndrome, Approved February 2012

Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012

Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012

Signifor (pasireotide diaspartate); Novartis; For the treatment of Cushing's disease, Approved December of 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

4. Family Medicine

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012

Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012

Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012

Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012

Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s syndrome, Approved February 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012

Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012

Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 2012

Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy menstrual bleeding, Approved March 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012

Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012

5. Gastroenterology

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012

Gattex (teduglutide); NPS Pharmaceuticals; For the treatment of short bowel syndrome, Approved December 2012

Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

6. Genetic Disease

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial hypercholesterolemia, Approved December of 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

7. Hematology

Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012

Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012

Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012

Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012

Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012

8. Hepatology (Liver, Pancreatic, Gall Bladder)

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

9. Immunology

Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012

Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

10. Infections and Infectious Diseases

Abthrax (raxibacumab); GlaxoSmithKline; For the treatment and prevention of anthrax, Approved December of 2012

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012

Fulyzaq (crofelemer); Salix Pharmaceuticals; For the treatment of non-infectious diarrhea in adults with HIV/AIDS, Approved December 2012

Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012

Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis, Approved December 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

11. Musculoskeletal

Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012

12. Nephrology

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 2012

Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012

13. Neurology

Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism resulting from nonvalvular atrial fibrillation, Approved December 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

14. Nutrition and Weight Loss

Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012

Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012

15. Obstetrics/Gynecology (Women’s Health)

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy menstrual bleeding, Approved March 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

16. Oncology

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012

Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012

Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012

Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

17. Ophthalmology

Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012

Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012

Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012

Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012

18. Orthopedics/Orthopedic Surgery

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

19. Otolaryngology (Ear, Nose, Throat)

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

20. Pediatrics/Neonatology

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

21. Pharmacology/Toxicology

Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012

22. Psychiatry/Psychology

Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

23. Pulmonary/Respiratory Diseases

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis, Approved December 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

24. Rheumatology

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012
Trauma (Emergency, Injury, Surgery)

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

25. Urology

Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved February 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc.; For the treatment of overactive bladder, Approved June 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

26. Vaccines

Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and type B, Approved November 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Personal Note: I was the Chemistry Team Leader in the Division of Anti-Infective Drug Products, New Drug Chemistry, prior to my retirement from FDA in 2002. I was responsible for all the Chemistry, Manufacturing and Control (CMC) requirements for all new drugs prior to approval supervising the work of 5 to 6 Chemistry Reviewers.

Aswang and Dystonia Parkinsonism (Lubag) of Panay Island, Philippines

Halloween is still about 6 months away, but today I am sharing with you a video about witches ( or aswang) of the Philippines. I accidentally found this video while doing a search on parkinsonism. I found that there is a malady endemic to Panay Island associated with witches, because of the muscle twitching. The local residents called it lubag which meant twitching in their dialect. The video indicated that this may be the reason why the province of Capiz, Panay Island is often associated with the home of the aswangs.

So what is lubag? It is a sex linked recessive dystonia parkinsonism (XDP) discovered in Panay Island in the mid 1970's. It is a movement disorder unique to adult Filipino men whose ancestries can be traced to only to Panay Island, Philippines. It is characterized by severe, progressive torsion dystonia, which dominates the first 10 to 15 years of the illness and is associated or replaced by parkinsonian features in the later years of life. This malady was believed to be caused by the aswang or witches of the area.

Have you heard of the word aswang? If you are a Filipino, you know what is an aswang. But for my non-Filipino readers, Aswang (or Asuwang) is a mythical creature in Filipino folklore. The aswang is an inherently evil vampire-like creature and is the subject of a wide variety of myths and stories. Spanish colonists noted that the Aswang was the most feared among the mythical creatures of the Philippines, even in the 16th century.

The myth of the aswang is well known throughout the Philippines, except in the Ilocos region, which is the only region that does not have an equivalent myth. It is especially popular in the Western Visayan regions such as Capiz, Iloilo, Negros, Bohol, Masbate, Aklan, Antique. Other regional names for the aswang include "tik-tik", "wak-wak" and "soc-soc".

I grew up in the Philippines, so my parents had inculcated in my mind as a child to be afraid of witches at night. Today, as an adult residing in the US, the aswang phenomena was just a part of my childhood years and I have outgrown it.

Thanks for the video, Mr Jordan Clark. It is a well done and researched documentary indeed! I hope you enjoy this video as much as I do. It is one of the best documentary I have seen about the aswang of the Philippines.

Memories of a Declamation Contest-Rizal's Ultimo Adios

When I was in 6th grade, I participated in a declamation contest sponsored by our school district. There were ten schools in our district from three neighboring towns. If you have not heard of a declamation contest: It is just public speaking contest reciting and acting poetry, a short story or an article. My English teacher was my coach. I remember memorizing for 4 weeks, a short story titled "A Yankee in Love". The short article were filled with American slang words that I could barely understand. The piece was more suited to an older teenager, possibly someone who has already fallen in love. As a result I delivered my declamation piece without any feelings or emotion but with an American accent taught by my coach. But I was surprise to win 5th place ( among 10 contestants). The winner was from the school in the next town and I remember very well her declamation piece was Jose Rizal famous poem, My Last Farewell.( Ultimo Adios in Spanish). Jose Rizal is Philippines number one national hero. December 30 is Rizal Day in the Philippines.

Here's the first and last stanzas of this patriotic poem both in its original Spanish and an English translation. The poem has 14 five-lines stanzas and has been translated into 30 languages. I will never forget this poem as long as I live because of the Declamation Contest that I lost during my elementary school days in the Philippines.

Mi Ultimo Adiós.

Adios, Patria adorada, región del sol querida,
Perla del Mar del Oriente, nuestro perdido Eden!
A darte voy alegre la triste mustia vida,
Y fuera más brillante más fresca, más florida,
Tambien por tí la diera, la diera por tu bien.

Adios, padres y hermanos, trozos del alma mía,
Amigos de la infancia en el perdido hogar,
Dad gracias que descanso del fatigoso día;
Adios, dulce extrangera, mi amiga, mi alegria,
Adios, queridos seres, morir es descansar.

An English Translation

My Final Farewell

Farewell, dear Fatherland, clime of the sun caress’d
Pearl of the Orient seas, our Eden lost!,
Gladly now I go to give thee this faded life’s best,
And were it brighter, fresher, or more blest
Still would I give it thee, nor count the cost.

Farewell to you all, from my soul torn away,
Friends of my childhood in the home dispossessed!
Give thanks that I rest from the wearisome day!
Farewell to thee, too, sweet friend that lightened my way;
Beloved creatures all, farewell! In death there is rest!


The last phrase, "In death there is rest" ( morir es descansar) is appropriate in Rizal's Life. Dr. Jose Rizal who was executed by the Spanish colonizers of the Philippines on December 30, 1896 for his alleged role in the armed revolution against Spain. He was in prison and on the night before his execution, he wrote this poem as a final statement to his fellow Filipino countrymen. Here's a partial video of the poem sang and with English sub titles.


The "Mi Ultimo Adios"(My Last Farewell) was originally written in Spanish. I feel that the English translation loses the depth of emotion Dr. Rizal felt at the time he wrote it. The poem is so inspiring, I do not get tired reading it again and again. How about you?

Blue Birds in My Backyard-Happy Father's Day

It is already Father's Day in the Philippines. Here in Northern California Fathers Day will be tomorrow. Next week will be the official first day of summer. However, since mid-May this year six Blue Jays have been frolicking with abandon in my backyard. Two are the parent birds and four are the babies. I have been feeding them with bread crumbs and rice morsels, and faithfully replacing their bird bath and water every day.

For the last four years from Spring To Fall I have bluebirds residing in my back yard here in Northern California. They nest and play in the Holly and Pyracantha Shrubs planted as screens for the small swimming pool in my backyard. In addition, this year I have a pair of mallard ducks rollicking in my swimming pool every now and then. The pair of Mallard ducks are tame, so they must be pets of neighbors. They love to swim in the pool and sun bath on the sides.


As far as blue jays: Are blue jays common in my neighborhood ? I know my yard is the only one with four or more residents of blue jays that enjoys the water and food that I give them every day. Sometimes, I forget to give them bread crumbs or rice. They will remind me by their loud chirping, jumping and coming closer to the patio. They are getting so tame, that they stay only a few feet from their feeding station when I go out to give their daily bread crumbs or rice morsel. As soon as I put the food in the feeder, they would happily consume the food and bring some to their nests for their babies. If I gave them too much food, the leftover is welcome by a couple of residents squirrels in the yard.

The blue jays are also a favorite of my grand daughter, Carenna. When she visits us, the first thing she would ask is if she could feed the birds. I consider these birds my pets. We have pets in the Philippines, one dog, two cats and several chickens. But here in Northern California, our only pets are these blue jays that reside in my back yard during spring, summer and fall in this beautiful Northern California neighborhood every year. However,occasionally we house sit for Gimlet, our daughter pet cat. Do you have pets in your back yard?

Oh, Yes, happy fathers day again to all fathers of the world!

Blueberries Pancakes for Breakfast

I learned to cook blueberries pancake, yesterday. In my previous posting about cooking, I wrote about my feeling of accomplishment after I cooked my first Filipino dish ( Chicken Tinola with Vegetables) with out the supervision of my wife. Please note that my wife was an excellent cook before her PD diagnosis, so I during the last 55 years of our marriage, I never intrude in her kitchen except to wash dishes.

Yesterday, I cooked my first pancake recipe without my wife supervision by just following the instruction in the box. This event was inspired when I saw fresh blueberries in the Farmer's Market near us. The blueberries are in season now here in Northern California. They look so fresh and yummy, I purchased a pint for less than $3.

I purchased a pancake mix from Raley's ( any brand will do) with an instruction that I followed as follows: Mixed 2 cups pancake mix, 1 cup milk and 2 eggs in a bowl. Mixed thoroughly. Add the pint of washed blueberries. Mixed and scoop a big spoonful or two of the mix in a flat electric skillet or at top of stove at medium heat. Do not forget to add cooking oil in the flat pan. Turn the pancake as soon as one side is brown. In 15 minutes I had 14-6 inches blueberries pancake for my wife and my breakfast. Easy and Fast.

Again, I can not believe, I can cook excellent pancakes without any sweat. Serve with bacon and brewed Baracco coffee from the Philippines. You can add butter or syrup or powdered sugar in your pancake if you wish. I am so proud of my newly discovered talent.

Top Fifteen Pharmaceutical Firms in the World

Last week, I posted a list of top ten pesticides manufacturer of the world. One of my readers suggested I post a similar list for drug firms having been a former FDA employee. Yes, indeed as former FDA employee involved in the approval of new drugs, the subject of pharmaceutical firms, doing well really interest me. There was a report in Forbes Magazine by Mathew Herper( 2012) listing the top 15 best pharmaceutical firms based on the number of new drugs ( new chemical entity -NCE) approved by FDA. NCE is a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

The list is as follow with reference noted below.

Table 1:Top 15 Firms Based on New Drugs Approved for the past 15 Years

Company - Number of New Drugs
Novartis 17
Merck&Co 16
J&J 15
Pfizer 14
Wyeth 13
Bristol-Myers 11
Hoffmann/Roche 11
Lilly 11
GlaxoSmithKline 10
Abbott 9
Amgen 9
Pharmacia/Upjohn 9

Source: Bernard Munos, InnoThink Center for Research in Biomedical Innovation

On the other hand the top ten pharmaceutical firms based on Dollars sales for 2012 is as follows:

Table 2: Special Report: Top Pharma Companies by 2012 Revenues-Billion of Dollars *
1 Johnson & Johnson- 67.2
2 Pfizer- 58.9
3 Novartis- 56.7
4 Roche- 47.8
5 Merck- 47.2
6 Sanofi- 46.4
7 GlaxoSmithKline- 39.9
8 Abbott Laboratories/AbbVie- 37.8
9 AstraZeneca - 27.9
10 Bayer HealthCare- 24.3

*Reference: Pfizer - FiercePharma http://www.fiercepharma.com/special-reports/pfizer

Note: Based on the two tables above, four firms are confirmed not only to be innovative but also profitable. The firms are J&J, Novartis, Merck and Pfizer. Wyeth and Roche made it to the top five firms for Table 1 and 2 respectively.

No Mas Amor que el Tuyo-Song for the Most Sacred Heart of Jesus

The above song reminded me of my childhood years, when I hear my Mother sing this song in church and also in our house.

This is a song in honor of the Most Sacred Heart of Jesus. It is one of the most popular spanish religious song in the Philippines in the 20th century. It was written by Manuel Bernabe, a Filipino poet who was a master of the Spanish and Latin languages. Bernabe was one of the most gifted luminaries of early 20th century, whose volume of work spanned translations, anthologies, and countless poems. No Mas Amor was originally written as a poem, and then set to music by Simeon Resurreccion.

No mas amor que el Tuyo
O corazon divino,
El pueblo Filipino,
Te da su corazon.
En templos y en hogares,
Te invoque nuestra lengua,
Tu reinaras sin mengua
De Aparri hasta Jolo.

Coro:

Ha tiempo que esperamos
Tu imperio en el Oriente,
La fe de Filipinas
Es como el sol ardiente,
como la roca firme,
Inmensa como el mar.
La iniquidad no puede
Ser de estas islas duena
Que izada en nuestros montes,
Tu celestial ensena,
Las puertas de infierno
No prevaleceran.

There is no greater love than yours

There is no greater love than yours, O Most Sacred Heart,
so we, the Filipino people, offer you our hearts.
In our temples and in our homes, we cry out to you.
May Your kingdom stand firm from Aparri to Jolo.

Chorus:

Long we have hoped for Your empire in the East.
Like the sun burning bright is the faith of the Philippines,
It stands strong like a rock and fills all void like the sea.
Never shall these islands be possessed by sin,
For on our mountains is raised your heavenly sign
And the gates of Hell shall not prevail.

Advantages of Dual Citizenship (PHL and US)

About two years ago, I reacquired my Filipino citizenship. I became a dual citizen of the US and of the Philippines. After a slow two hours and foggy drive from Sacramento to San Francisco, Macrine and I with son David arrived at the Philippine Consulate at Sutter Street at 9:30AM. After one hour I was ready to be sworn in and took the Oath of Allegiance in the presence Of Alfonso A. Ver, Deputy Consul General, Philippine Cosulate, San Francisco, California.

It was a very smooth process although six other Filipino-Americans were also applying along with me at that time. We were out of the consulate by 11AM, plenty of time to celebrate my birthday lunch at Fisherman's. Wharf with Dungeness crabs that was in season at that time.

I applaud the Consulate for the smooth process. The application fee was $50. So why did I apply for dual citizenship. The advantages are as follows:

1. One who re-acquires Filipino citizenship can vote in elections in the Philippines according to Art V, Sec.1 of the Philippine Constitution.

2. One can own real property with no size limitation.

3. One can practice his/her profession provided he/she is licensed or permitted by the Philippine authority to engage in such practice ( RA 9225).

4. One can own and operate a business not generally open to foreigners among others, explorations, public utilities, mass media, cooperatives, and advertising.

5. The citizen's spouse can get an immigrant visa that entitles him/her to permanently reside in the Philippines - come and go, avoid exit clearances, entry fees, etc.

6. Can run or get an appointment to a public office provided that the person renounce his allegiance to the other country.

7. Can apply for Philippine passport and can stay in the Philippines for an unlimited period.

Ownership of real property is a significant advantage, as existing law in the Philippines restricts ownership of real property to its own citizens. Although a foreigner is permitted to take title to a condominium, he/she cannot take title to real property (land and a house). A foreigner can lease land from a Filipino and then take ownership of a house on the land, but this type of transaction is extremely rare in the Philippines. Thus, through re-acquisition of his/her Philippine citizenship, the Filipino is once again able to purchase real property, with no restrictions.

For those wanting to retire to the Philippines, the ability to run a small business or practice one's profession is a strong benefit. Through dual citizenship, retirement in the Philippines can be the start of a new chapter in one's life, as a business person or a professional. Ownership of business as a sole proprietor or as a wholly owned corporation is severely restricted, unless a foreigner makes a significant investment ($200,000 as a minimum).

Without citizenship, a foreigner wishing to operate a business in the Philippines is limited to forming a corporation, of which he/she can only own a 40% interest. As a dual citizen, the Filipino re-acquires the right to wholly own his/her business. Thus, a foreigner married to a Filipino with dual citizenship can take 40% ownership of a business and keep it in the family by his/her dual citizenship spouse taking the remaining 60% ownership.

Other than being in an immigrant status, there is only one way a person carrying a foreign passport can reside in the Philippines for any significant amount of time, and even then it requires the foreigner to be married to a "Balikbayan" (a returning Filipino who was born in the Philippines). A Balikbayan and his/her spouse can visit and reside in the Philippines for up to one year, after which they must exit the country, and then re-enter should they wish to stay another year. This must be repeated on an annual basis

Balikbayan status is not an immigrant status, but rather a special non-immigrant visa status. Yes, one can enter without a visa and stay for a maximum of 21 days, and then get a renewal for another 38 days, followed by two month extensions for about USD $100 per extension, up to a maximum of one year. There is also a special retiree visa program permitting unlimited stay status, but it does not permit real property or business ownership.

There are only two ways for a foreigner to be registered as a non-quota immigrant and those are (i) be the spouse of a Filipino citizen who was never became a citizen of a foreign country, or (ii) be the spouse of a former Filipino citizen who has re-acquired his/her citizenship by obtaining a dual citizenship status. If desired, the door is open after 5 years residency for the foreigner to also obtain dual citizenship.

With a dual citizenship status, the Filipino has the best of both worlds - citizenship in the Philippines and all the rights that attach to that plus citizenship in his/her other country (e.g., Canada or USA) and all the rights that attach to that status.

But there are duties and obligations one must follow: Exercise the right to vote, pay taxes on income earned in the Philippines. Last but not least, support and defend the Constitution of the Philippines and obey its laws. To apply for dual citizenship call the Philippine Consulate nearest to your residence.

References: Will Irwin (http://www.retirementlivinginthephilippines.com)and brochure from the Philippine consulate, San Francisco, California, USA

Personal Note: On item 6 above, there are a number of cases in the last Philippine election that a dual citizen was elected, but has no proof of renouncing US citizenship. The most discussed case here by American-Marinduquenos is the case of Gina Reyes. Although she is a dual citizen and claims she renounced her US citizenship before her filing her certificate of candidacy, she has not shown proof of her renouncing her US citizenship.