My Wife Quit Smoking Cold Turkey

After 40 years of smoking my wife decided to quit smoking cold turkey last month. I am so happy for her and I admired her for her decision. During the last 40 years she tried to quit at least 3 times. The first time was through an aversion therapy clinic sponsored by my former employer. She quit for three weeks and had a relapse. The other two times were her cold turkey attempts. Her last attempt and hopefully a successful one was last month. I bought a nicotine patch package, but she did not used it. As of today 4 weeks after she quit, she appears to be well adjusted and had not touched a cigarette. Her withdrawal symptoms were mild, thanks heavens.

I attribute her success so far to the following health events in her life. Six months ago she was diagnosed with PD. After a brain scan the neurologist observed that she had also a mild heart attack (TIA) that we were not aware of. A week later after all tests( 5 diagnostic tests) were conducted, she was diagnosed to have right carotid artery stenosis with infarction. The doctor advised her to quit smoking, but she was not ready. Five days ago she had carotid endarterectomy surgery and now recuperating very well from the surgery. One of the post operative care was to quit smoking. She decided to quit cold turkey and hopefully there will be no relapse this time. Here are the benefits of stopping smoking: Within hours of stopping cigarettes, the body starts to recover from the effects of nicotine and additives. Blood pressure, heart rate, and body temperature, all of which are elevated because of the nicotine in cigarettes, return to healthier levels. The lung capacity increases and the bronchial tubes relax, making breathing easier. Poisonous carbon monoxide in the blood decreases, allowing the blood to carry more oxygen. Quitting smoking is one of the best things one can do, for short and long-term health. In addition, you save money by not buying cigarettes and in our case, that is about $150 savings in our monthly budget and expenses.

The following video is informative and most of what the video says applied to my wife's cold turkey experiences.


If you were a smoker who quit cold turkey, please share your experiences, so we may be able to help them in their nicotine addiction.

Pentatonix-Best Acapella Quintet

Last night NBC Sing Off Singing Program premiered its second season. In the audience were the Pentatonix Quintet. Nick Lachey, the emcee announced that the group will perform as guest singers in the next show tomorrow. He also announced they were the last year winner of the show. I do believe that this group is best Acapella quintet of the decade. If this is the first time you heard the group, you are in good company.

Garden Salad with Dungeness Crabs

I was looking for the easiest recipe for garden salad with crab meat the other day. I found this recipe ( Food network) called the New Orleans Style. However, this is similar to my wife's recipe of Crab Louie salad.
My wife has the same recipe without the green onions and the olives.( a much simpler recipe)

1 head iceberg lettuce, cored and cubed
1 pound lump crabmeat, picked over for shells and cartilage(Dungeness preferred)
1/2 cup chopped yellow onions
1/2 cup chopped celery
1/2 cup roughly chopped pimiento-stuffed green olives (about 8 large)
2 tablespoons chopped green onions
2 tablespoons chopped parsley
2/3 cup olive oil
1/3 cup red wine vinegar
1 teaspoon minced garlic
1/2 teaspoon salt
1/4 teaspoon freshly ground black pepper

In a large bowl, combine the lettuce, crabmeat, onions, celery, olives, green onions, and parsley. In a small bowl, combine the oil, vinegar, garlic, salt, and pepper, and whisk to blend. Pour over the crabmeat mixture. Toss gently to coat, being careful to not to break up the crabmeat lumps. Adjust seasoning, to taste.

Refrigerate until well chilled and the crabmeat is marinated, at least 2 hours. Serve.

Reference: http://www.foodnetwork.com/recipes/emeril-lagasse/new-orleans-style-crabmeat-salad-recipe/index.html?oc=linkback

Ludong-Most Expensive Fish in the Philippines

Ludong or Pacific Salmon-the most expensive fish in the Philippines

The Ludong or Lobed river mullet is a freshwater mullet. While it is claimed to be endemic to Cagayan River and tributaries extending through the watersheds of Cagayan Valley and the Santa-Abra River Systems of Ilocos Sur and Abra in the Philippines, verifiable and reliable sources have listed Celebes, New Caledonia, New Hebrides, and Fiji as areas where the lobed river mullet may be also found. It is sometimes called the Pacific Salmon or the President's fish, since only the President and the rich will be able to afford it.

Ludong is herbivorous, eating only the filamentous algae that live on rocks and boulders in and near river rapids.

A mature fish weighs from 0.25 kg to 2 kg and costs P4,000- P5,000 a kilo, making it the most expensive fish in the country. At today's exchange rate that is about $100 to $200 a kilo or around $40 to $80 per lb. It commands a very high price in the market because it is seasonal and difficult to catch and an has an excellent aroma and taste when cooked. Its unique taste makes it one of the most sought-after ingredients in making delicious dishes.

This elusive fish is catadromous in nature; it migrates to the ocean to breed. It swims to salt water to spawn from October to December and returns to upstream ponds after. It undergoes upstream migration during December, January, and February, and this coincides with the “ipon-run phenomenon’ wherein different species of fish fry also undergo upstream migration. After the ludong had undergone downstream migration, it can be caught in Cagayan River and tributaries.

Ludong is close to being an endangered species, considering its threatened state in the Northern Luzon waters. In fact, information gathered from fish vendors in Cagayan showed that the volume of ludong catch has been tremendously decreasing annually. Thus this week the Bureau of Fisheries and Aquatic Resources (BFAR) issued a 3-month moratorium in the fishing of this river mullet.

In 2006, BFAR launched Sagip Ludong, a wide fish-hunt in Aparri for 60 pieces of live ludong. The hunt was conducted during the first half of October because it provides the best opportunity to catch live ludong, which seasonally appears two to six times only in a year from October to November.

Another expensive and rare fish in Marinduque is the Bingao. It is a big ocean fish belonging to the red snapper family. It is very tasty and has no fishy smell when cooked. It taste like pork or eel. Last year I paid 400 pesos per kilo from a fisherman neighbor here in Amoingon, Boac. A lottery is held by the fish vendors if one fish is available for sale to avoid fist fights in the market place. At least this 400 pesos/kilo price is affordable, since I will never pay 4000 pesos a kilo for a fish, unless I won the lottery or I become President or someone treats me with a ludong feast.

Reference: Wikipedia

The 72nd Anniversary of the Bombing of Pearl Harbor

I was only 7 years old when Japan bombed Pearl Harbor, Hawaii on December 7, 1941. The attack lasted less than two hours, but it took an incredible toll of four battleships sunk, 188 aircraft destroyed, and 2,403 Americans killed. On the other hand, Japan lost only 64 men and 29 planes. Life Magazine wrote in its December 15, 1941, issue, "World War II came with startling suddenness to America. With reckless daring Japan aimed this blow at the citadel of American power in the Pacific. World War II lasted four more years, until Germany surrendered in May of 1945. Japan surrendered four months later, in the wake of America's destruction of Hiroshima and Nagasaki. The attack on Pearl Harbor, rather than a great Japanese victory, turned out to be an act of belligerent folly that, in elemental ways, guaranteed the Land of the Rising Sun's eventual defeat".

This day always reminds me of my childhood experiences of the Japanese-American War in the Philippines. I wrote an article on this subject in one of my blogs and today I am delighted to re post so that we will not forget the horrors of war. There are no winners in war, everyone are losers!

"Life in the time of war is a difficult experience for a child. All school and play activities are interrupted. Survival amidst the chaos becomes a paramount goal in life. Our family had to uproot ourselves from the comfort of home and move several times to the hard life in the countryside. We had to avoid the conflict and the bombing in the city.

We chose a life of peace and quiet away from the invading Japanese troops. Due to the language barrier, the Japanese instilled order and dominance of the conquered using fear, by hurting or killing innocent civilians, resulting in the rise of the resistance movement. For every day that passes, there was the dream of peace, but during the lengthy war period, one had to expect the worst before anything good happened.

Before the war started, we lived a comfortable life in our home in the city of Jaro, Iloilo located in the central Philippine island of Panay. My father had a dental practice and we had our farm landholdings around the province. It was 13 days before my 7th birthday when the Japanese bombed Pearl Harbor in Hawaii in the morning of December 7, 1941.

On that evening, Japanese planes had taken off to attack several targets in the Philippines, which was then an American colony. It was the start of the Japanese invasion of the Philippines, and the reign of fear was about to begin.

I was in 2nd grade at the Jaro Elementary School when Japan started bombing the bigger cities of the country. When we heard the terrifying news, my parents became concerned for our safety and decided to get out of the city, a possible bombing target.

They chose to move to our farm in the small town of Barotac Viejo, Iloilo, my mother’s ancestral town 60 kilometers north of Jaro. It was a time of panic, chaos and fear over what was to happen in the city. We were about to leave our cherished home and anxiously head to the unfamiliar and unknown.

Within a couple of days all the essential items we could bring were already packed. All the furniture and the huge and heavy items were left behind. My mother had all her china and silverware buried in the backyard for safekeeping.

We found out later that our house was bombed and totally destroyed. All the furniture were either destroyed or stolen. All the china and silverware was dug up and stolen. Despite the losses, we were grateful that we made a wise decision and survived unharmed.

For a short period we settled in a small farm house of our tenant in a remote district of town. As the war progressed, we were informed that the Japanese forces had penetrated most of the big cities in the country and were starting to occupy smaller towns. My father was a captain and dental officer of the newly organized Philippine guerrillas, an underground resistance movement to fight the Japanese. As a precaution, he decided to move our family a second time, to the jungle in the interior of Panay Island.

We had to walk for three days through the woods of the jungle, cross over numerous creeks and climb over mountains with the help and guidance of our farmer tenants. Our trek ended and we settled in a hidden valley lined by a creek with clean running water. Our tenants built us a hut for shelter made of bamboo and nipa palm, an outdoor kitchen and a dining area.

They used a bamboo cart pulled by a water Buffalo to bring us supplies of rice, salt, sugar and other spices regularly. In the valley we cleared the land to plant vegetables, corn and sweet potatoes. We also raised chickens and ducks for eggs, pigs for protein and goats for milk.

One of the scariest events while living in the jungle was when our pig livestock were preyed upon by a python snake measuring about 30 feet long. It was pitch black at night when we heard our two pigs squealing out loud in fear. My father instructed our helper to inspect the pig pen using a kerosene lamp.

He saw the snake strangling one of the pigs. He struck and killed the python using his machete and a piece of wood, sadly, our small pig also died. That whole week we had protein in our meals. It was proof that the jungles of Panay are inhabited by dangerous pythons.

We had no pet with us. I chose the chickens and the goats to become my pets. I raised one of the chickens; it slept with me, got attached to me and kept trailing me wherever I go. My mother tolerated my unusual pets because I had no peers my age aside from my younger brother.

To continue with our education, my father home schooled us together with two of my older cousins. For four hours each day we were taught arithmetic, spelling and history. We were lucky to have brought with us a few books on Philippine and US history. Whenever our tenants brought us food supplies, they would update us on news about the status of the Japanese occupation.

Late in the war when the Japanese brutality and atrocities appeared to have stopped, we moved again from the jungle to a seaside village. We stayed at the house of another tenant. My father warned us not to talk to any stranger, and if asked, to avoid giving our real last name of Katague and instead provide an alias which was Katigbak.

There were unverified rumors that the Japanese had a list of names of all the guerrillas, which might have included my father. Some traitor Filipinos worked as spies for the Japanese by pinpointing the guerrillas in exchange for favors.

One day, we saw a platoon of uniformed Japanese soldiers armed with guns and bayonets passing by our village. My brother and I watched them march while hiding in the bushes. I knew their brutal reputation towards the natives, and I was afraid of us being seen and getting in trouble. I was relieved that nothing happened and they continued with their march to the next village.

A terrible incident happened to about 30 of my maternal relatives while we were living in the jungle. They were similarly hiding and living in the jungle on a mountain ridge next to us. They were killed by the Japanese soldiers who discovered and penetrated their location with the help of the spies.

A handicapped relative in a wheelchair was spared. During the massacre, she fell on the creek and must have been left for dead. She lived to tell the tragic story. This is only one example of many atrocities that was committed by the Japanese to the Filipino civilians.

When General MacArthur landed in Leyte on October 1944, it was the happiest day for the Filipinos, the Americans were back to save us from the Japanese tyranny. The Japanese troops started to retreat and surrender. The chance for peace in the Philippines was welcomed with excitement. The schools were planning to reopen. There was no more need to live in hiding and in fear, and to lie about one’s name. We were able to live free from the oppressors.

From the seaside village we moved to another district much closer to town where we built a bigger house. At the back of the property was a hill, and on a clear day, from the top of the hill you could see the nearby island of Negros.

We used it as an observation hill where we could watch the Japanese and American planes flying and then fighting each other. My brother and I witnessed two planes attacking each other, with one plane being blown to pieces and burning as it fell from the sky to the sea between Panay and Negros islands. It was a thrilling dogfight show to watch, although we never found out the victor.

When school reopened, we were required to take a test to determine which grade level we would qualify for. I passed the test for a 4th grade level. I was merely in grade 2 when war broke out. In short, I completed six grades of elementary in only four years of schooling. In class, I was two years younger than most of my classmates. I was thankful for the result of my father’s patience in home schooling us while living in the jungle. At last we were able to go back to our school, new home, and live the life of what was left of my childhood years in peace".

Chemistry, Manufacturing and Controls of NDA's

The other day, my wife asked me a what if question. She ask that if I have a chance and be granted a wish, would I be willing to take back my job as a Chemistry Team Leader for the Food and Drug Administration since my mind is still sharp. Without hesitation I said no and explained to her about the two facets of my responsibilities as a first line supervisor in charge of the Chemistry, Manufacturing and Control requirements for a New Drug Application (NDA) in the Division of Anti-Infective Drug Products.

The first facet is my interaction with Chemists and Reviewers under my supervision and from other Divisions. I will have no problem handling that today. The second facet is my interaction with the representatives of the Pharmaceutical companies that FDA regulates. This facet requires up to date knowledge of laws, regulations and Guidances. Today, I feel I will not be as sharp and well-prepared to this part of my responsibilities if I am still a Chemistry Team Leader for FDA. There are 43 CMC Guidances that a team leader should know by heart and mind. At this stage of my life, I believe I will not be able to handle the pressure and responsibilities on this facet of a team leader job.

In my previous posting, I discuss a general overview of new drug development(NDA) and FDA's role in the process. In this article I am focusing on the Chemistry portion of a new drug application which was my expertise when I was still working for FDA from September,1990 up to October,2002. I am listing below a table of all CMC Guidances both in draft and final form. As a former Chemistry team leader in the Division of Anti-Infectives Drug Products in the Center of New Drugs Chemistry, I have some input on the contents of a few of these guidances. These 43 guidances are available in the Internet for everyone.

Below is a table of Chemistry, Manufacturing and Controls (CMC) Guidances showing,
category, title status( draft or final) and date.

1. Chemistry, Manufacturing, and Controls (CMC) Analytical Procedures and Methods Validation (PDF - 91KB)1 Draft Guidance 08/30/00

2. Chemistry, Manufacturing, and Controls (CMC) Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161KB)2 Draft Guidance 12/04/09

3. Chemistry, Manufacturing, and Controls (CMC) Botanical Drug Products (PDF - 437KB)3 Final Guidance 06/01/04

4. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33KB)4 Final Guidance 07/01/97

5. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA (PDF - 108KB)5 Final Guidance 04/01/04

6. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB)6 Final Guidance 01/01/01

7. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 18KB)7 Final Guidance 11/19/04

8. Chemistry, Manufacturing, and Controls (CMC) CMC Postapproval Manufacturing Changes Reportable in Annual Reports (PDF - 78KB)8 Draft Guidance 06/24/10

9. Chemistry, Manufacturing, and Controls (CMC) Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)9 Draft Guidance 02/25/03

10. Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)10 Final Guidance 05/01/99

11.Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for
Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB)11 Final Guidance 05/01/02

12. Chemistry, Manufacturing, and Controls (CMC) Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products12 Final Guidance 04/01/96

13, Chemistry, Manufacturing, and Controls (CMC) Development of New Stereoisomeric Drugs13 Final Guidance 05/01/92

14. Chemistry, Manufacturing and Controls (CMC) Drug Master Files (DMFs)14 Additional Information regarding DMF's

15. Chemistry, Manufacturing, and Controls (CMC) Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23KB)15 Final Guidance 11/01/99

16. Chemistry, Manufacturing, and Controls (CMC) Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB) Draft Guidance 09/11/02

17. Chemistry, Manufacturing, and Controls (CMC) Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)17 Final Guidance 07/01/98

18. Chemistry, Manufacturing, and Controls (CMC) Format and Content for the CMC Section of an Annual Report (PDF - 29KB)18 Final Guidance 09/01/94

19. Chemistry, Manufacturing, and Controls (CMC) Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79KB)19 Draft Guidance 07/14/09

20. Chemistry, Manufacturing, and Controls (CMC) INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 193KB)20 Final Guidance 05/20/03

21. Chemistry, Manufacturing, and Controls (CMC) IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)21 Final Guidance 05/01/01

22. Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)22

23. Chemistry, Manufacturing, and Controls (CMC) Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 45KB)23 Draft Guidance 08/21/02

24. Chemistry, Manufacturing, and Controls (CMC) Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29KB)24 Final Guidance 03/01/01

25. Chemistry, Manufacturing, and Controls (CMC) Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361KB)25 Draft Guidance 11/19/98

26. Chemistry, Manufacturing, and Controls (CMC) Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 116KB)26 Final Guidance 07/01/02

27. Chemistry, Manufacturing, and Controls (CMC) NDAs: Impurities in Drug Substances (PDF - 11KB)27 Final Guidance 02/01/00

28. Chemistry, Manufacturing, and Controls (CMC) Orally Disintegrating Tablets (PDF - 52KB)28 Final Guidance 12/17/08

29. Chemistry, Manufacturing, and Controls (CMC) PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76KB)29 Final Guidance 04/28/98

30. Chemistry, Manufacturing, and Controls (CMC) Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB)30 Draft Guidance 08/02/10

31. Chemistry, Manufacturing, and Controls (CMC) Residual Solvents in Drug Products Marketed in the United States (PDF - 52KB)31 Final Guidance 11/24/09

32. Chemistry, Manufacturing, and Controls (CMC) Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703KB)32 Final Guidance 11/01/94

33. Chemistry, Manufacturing, and Controls (CMC) Size of Beads in Drug Products Labeled for Sprinkle (PDF - 43KB)33 Draft Guidance 01/18/11

34. Chemistry, Manufacturing, and Controls (CMC) Submitting Documentation for the Manufacturing of and Controls for Drug Products (PDF - 1048KB)34 Final Guidance 02/01/87

35. Chemistry, Manufacturing, and Controls (CMC) Guidelines for Submitting Samples and Analytical Data for Methods Validation Final Guidance 02/01/87

36. Chemistry, Manufacturing, and Controls (CMC) Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94KB)36 Final Guidance 02/01/87

37. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB)37 Final Guidance 11/01/95

38. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR Questions and Answers about SUPAC-IR Guidance38 Final Guidance 02/18/97

39. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117KB)39 Final Guidance 01/01/99

40. Chemistry, Manufacturing, and Controls (CMC) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF - 215KB)40 Final Guidance 10/06/97

41. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61KB)41 Draft Guidance 12/01/98

42. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)42 Final Guidance 05/01/97

43. Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use 09/01/97

Note: As a Chemistry Team Leader, you need to be familiar with contents of these 43 Guidances, so when representatives from the Pharmaceutical firms ask you a question, you should be able to refer them to the guidance. If you can answer their question
without referring to the guidance, the firm's representative look at you with high regard and respect. It is therefore imperative that you know most of the important requirements for an New Drug application (NDA) submission as well as the post NDA requirements in the manufacture, chemistry and controls of an Investigational New Drug (IND) or NDA. A Guidance is not a Federal Regulation/Law. The 21CFR (Code of Federal Regulation), gives FDA mandate to enforce drug and food laws in US.

Source: www.fda.gov