Development of New Drugs in the US- An Update

Today's news of President Biden Plan on lowering drug prescription costs reminded me of my article about drug development in the US.

https://twitter.com/search?q=lower+cost+of+prescription+drugs&ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Esearch

 

I wrote this article a decade ago today. I believe the contents of this article is still valid today except the costs and success rate.

Development of New Drugs in the United States Schematic

Image from medscape.com

As a retired FDA involved in the development of new drugs in the Division of Anti-Infective Drug Products, Office of New Drug Chemistry, I had often been asked by several of my blog readers to write a summary and an overview of new drug development in the US. I had been postponing it, because I thought the subject is confidential, but when I started browsing in the WEB today, I found several articles on the subject. I even found a Chemistry manufacturing supplement that I had approved several years ago. The letter of approval and the chemist review was printed in the Internet. However, the specifics of the supplement was erased in the approval letter as well as in the chemist review. The patent of the drug discussed had expired, so it is open to generic companies, otherwise the chemist review and letter of approval will never be made public. I am getting out of the subject, but let me start on the subject right now.

New Chemical Entity (NCE) development

Broadly the process can be divided into pre-clinical and clinical work.

Pre-clinical.

New Chemical Entities (NCEs)(also known as New Molecular Entities (NMEs)) are compounds which emerge from the process of drug discovery. These will have promising activity against a particular biological target thought to be important in disease; however, little will be known about the safety, toxicity, pharmacokinetics and metabolism of this NCE in humans. It is the function of drug development to assess all of these parameters prior to human clinical trials. A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time an NCE is used in a human clinical trial ("first-in-man" (FIM) or First Human Dose (FHD)).

In addition, drug development is required to establish the physicochemical properties of the NCE: its chemical makeup, stability, solubility. The process by which the chemical is made will be optimized so that from being made at the bench on a milligram scale by a synthetic chemist, it can be manufactured on the kilogram and then on the ton scale. It will be further examined for its suitability to be made into capsules, tablets, aeresol, intramuscular injectable, subcuteneous injectable, or intravenous formulations. Together these processes are known in preclinical development as Chemistry, Manufacturing and Control (CMC).

Note: The CMC portion of was my primary function as the Team Chemistry Leader during my employment with FDA

Many aspects of drug development are focused on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in man. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs, brain, kidney, liver and digestive system), as well as effects on other parts of the body that might be affected by the drug (e.g. the skin if the new drug is to be delivered through the skin). While, increasingly, these tests can be made using in vitro methods (e.g. with isolated cells), many tests can only be made by using experimental animals, since it is only in an intact organism that the complex interplay of metabolism and drug exposure on toxicity can be examined.

The information gathered from this pre-clinical testing, as well as information on CMC, and is submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug application or IND. If the IND is approved, development moves to the clinical phase.

Clinical phase.

Clinical trials involves three steps: Phase I trials, usually in healthy patients, determine safety and dosing Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of sick patients Phase III trials a large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients

The process of drug development does not stop once an NCE begins human clinical trials. In addition to the tests required to move a novel drug into the clinic for the first time it is also important to ensure that long-term or chronic toxicities are determined, as well as effects on systems not previously monitored (fertility, reproduction, immune system, etc.). The compound will also be tested for its capability to cause cancer (carcinogenicity testing).

If a compound emerges from these tests with an acceptable toxicity and safety profile, and it can further be demonstrated to have the desired effect in clinical trials, then it can be submitted for marketing approval in the various countries where it will be sold. In the US, this process is called a New Drug Application or NDA. Most NCEs, however, fail during drug development, either because they have some unacceptable toxicity, or because they simply do not work in clinical trials.

As this drug discovery process becomes more expensive it is becoming important to look at new ways to bring forward NCEs. One approach to improve efficiency is to recognize that there are many steps requiring different levels of experimentation. The early phase of drug discovery actually has components of real innovation, components of experimentation and components that involve set routines. This model of Innovation, Experimentation, and Commoditization ensures that new ways to do work are adopted continually. This model also allows the discipline to use appropriate internal and external resources for the right work.

Costs

Studies published by diMasi et al in 2003 report an average pre-tax cost of approximately $800 million to bring a new drug (i.e. a drug with a new chemical entity) to market. A study published in 2006 estimates that costs vary from around $500 million to $2 billion depending on the therapy or the developing firm. A study published in 2010 in the journal Health Economics, including an author from the US Federal Trade Commission, was critical of the methods used by diMasi et al but came up with a higher estimate of ~$1.2B. Critic Marcia Angell, M.D., a former editor of the New England Journal of Medicine, has called that number grossly inflated, and estimates that the total is closer to $100 million. A 2011 study also critical of the diMasi methods, puts average costs at $55 million.

Success rate

Candidates for a new drug to treat a disease might theoretically include from 5,000 to 10,000 chemical compounds. On average about 250 of these will show sufficient promise for further evaluation using laboratory tests, mice and other test animals. Typically, about ten of these will qualify for tests on humans. A study conducted by the Tufts Center for the Study of Drug Development covering the 1980s and 1990s found that only 21.5 percent of drugs that start phase I trials are eventually approved for marketing. Now you know why the drugs you purchased in the pharmacy is very expensive ( except the generic drugs). Most Americans will not be able to afford new drugs if they do not have insurance.

The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act20 is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.Code of Federal Regulations (CFR)

Code Of Federal Regulations (CFR)21. The final regulations published in the Federal Register22 (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the The Federal Food, Drug, and Cosmetic Act23 and related statutes. Section 21 of the CFR24 contains most regulations pertaining to food and drugs.

Note: I hope you found the above posting informative. My next posting on this subject will be on the Chemistry, Manufacturing and Control(CMC) Requirements for IND's and NDA's. If you find this posting either boring or interesting, let me know via comments. Thank You.

 Comment:

Anonymous said...You have a very informative article, I hope the FDA does not condone your site for writing about their business. Would you know how much the FDA charges drug companies for testing each of their new drugs from start to finish? This must cost them a bundle because, FDA employs a plethora of highly educated doctors, scientists, mathematicians and business people. Jeffrey Ray

A very interesting interview about the development of new drugs by Dan Skovronsky, Director of Research and Development, Eli Lily. 

 

Meanwhile enjoy this photo from my collection-My Pineapple in my front Patio almost ready to be harvested.

-

 

 

My UnderGraduate College Years Memories and Activities for StoryWorth

 

Macrine (RIP) and my Bachelor's Degree Graduation Photos

Here's my response on my memories during my college years for my StoryWorth book**. This is an excerpt from Chapter 4 of my autobiography.

Chapter 4: College and Teaching Years, UP(1951-1959), Epilogues 2005, 2009 and 2014

My first two years was in UPIC ( University of the Philippines, Iloilo College). At that time, it was only a two year institution. I started as Pre-Med as requested by my mother. My mom always dreamed of having a physician in the family. I made good grades, "A"s and "B"s (1.0 and 2.0) in all my subjects, and obtained college and university scholarships during my first year. On my second year, I was awarded the Fernando Lopez Scholarship of free tuition fees for the whole year. The award was given to the student with the highest grade point average in the whole school. If there is a tie, the student with the most extracurricular activities wins the award.

 

I was also elected President of the University of the Philippines Student Catholic Action( UPSCA), Iloilo Chapter. With this activity, I corresponded with the President of UPSCA in Diliman UP Campus. At that time the president was Constantino Nieva, a law student from Marinduque. Later, he was ordained as a priest and studied in Rome, Italy for his Ph.D in Theology. Fr Nieva ( we call him Tito Tino, now) is the uncle of my wife, Macrine Nieva Jambalos Katague(RIP).

Life in UPIC went by very fast. In the Fall of 1953, I transferred to UP Diliman, College of Liberal Arts and decided to change my major to Chemistry. This change was inspired by my chemistry professor in UPIC. The fact that I hate the sight of blood, in my Zoology class dissecting frogs, made this change easy.

"There goes my mother's dream" is a phrase I will always remember. My mother always wanted to have a child who will be either a Physician or a Priest . My mother's dream was achieved when my niece, D'Wanie Katague Gregorio finished her MD degree, several years ago.

In Diliman, I resumed my active participation with UPSCA, becoming a member of the UPSCA Student Council representing my college. Our spiritual adviser was the late Fr. John Delaney, a Jesuit priest. The rivalry between the UPSCANS and the FRATS /SORORITIES was the most published and talked topic during that time. During my college years, the UPSCANS dominated student politics and until the death of Fr. John Delaney.

 

A circular chapel( Chapel of the Holy Sacrifice) in the Diliman campus was one of Fr. Delaney's project. During the ground breaking for the chapel, the names of one thousand (1000) students, faculty members and their families who went to mass and communion everyday for one year were buried in the church foundation. What an honor that my name was one of the one thousand names included in the church foundation.

The chapel is known for its architectural design, the church is recognized as a National Historical Landmark and a Cultural Treasure by the National Historical Commission of the Philippines, formerly the National Historical Institute, and the National Museum of the Philippines respectively. It was designed by the late National Artist for Architecture, Leandro Locsin, one of four National Artists who collaborated on the project. According to a post from the UP Diliman website, it is the only structure in the country where the works of four national artists can be found. Alfredo Junio served as the structural engineer for the project.

It was Fr. Tino(RIP) who first introduced me to his niece, Macrine Nieva Jambalos(RIP). That year, I also joined the "Chemical Society". As a neophyte, one of my task was to look for Macrine. I was not able to do it. At the same time, one member of the Chemical Society who resided in the same dormitory with Macrine knew that she was also looking for me. So we were playing "HIDE and SEEK'. Finally, Macrine and I met in the sacristy of the old chapel and the rest is history. Our college romance is too long to be included in this article. It will be another chapter in this book.

 

In 1955, I graduated with my B.S.in Chemistry degree. Right after graduation, I was appointed Instructor in Chemistry and taught General and Qualitative laboratory courses to pre-med, nursing and engineering students up to 1959. I was only 24 years old at that time. 

 

My college life and experiences will not be complete if I do not mention the Oblation Run.

The Oblation Run, UPLB( photo from photobucket.com)

 The "OBLATION RUN", an annual activity in UP that had been attracting nationwide visitors and the press. There was no Oblation Run during my college years. The two photos above are from the web, by photobucket.com (pinoyblogosphere).
 
The Oblation Run is an annual tradition of the members of the Alpha Phi Omega, one of the prominent U.P. fraternities. Members of the fraternity run around the campus naked (a concept known as streaking) to protest their sentiments about a current political or economic situation. The run started in 1977 to protest the banning of the movie, “Hubad na Bayani,” which depicted human rights abuses in the martial law era.

******************************************************************************
The following are excerpts from article by Paulo Alcazaren( City Sense, STAR) written several years ago brought pleasant memories of my college years and my first job as an Instructor in Chemistry at the University of the Philippines, Department of Chemistry ( 1957-1959).

December 20, 1955 ( also my 21st birthday) was the date when the first mass was held and the blessing of the chapel by Archbishop Rufino Santos. It was attended by an overflowing crowd of UP students and faculty members including most of the "1000" whose names were in the chapel foundation.

I am proud to remember, that my name is one of the 1000 names buried in the Foundation of the Chapel for completing the requirement of daily mass and communion for one year and pledging 5% of my student allowance to the building fund.

This article also reminded me of the war and struggle to control student government and campus life between the UPSCANS and the Fraternities/ Sororities. I was an UPSCAN then and one of the faithful apostles of Fr. John Patrick Delaney. Fr. John has a lot of influence on my life from that time and even today. His words of wisdom, charisma and encouragement still rings in my 86 years old body today.  

Here's excerpt of the article titled - CHAPEL OF HOLY SACRIFICE

UP, DILIMAN, December 21, 2005 (STAR) CITY SENSE By Paulo Alcazaren - My first memory of the University of the Philippines was in 1965. My father had bought me a toy rocket ship and we launched it from one of the many open green spaces set within the lush campus landscape. I thought at the time that it was cool that we were the first to bring the space age to the UP. I was wrong. I found out later that it had come much earlier – in 1955 – with the completion of the Chapel of the Holy Sacrifice, affectionately known as Diliman’s "flying saucer."

The interior space was enhanced with artwork – a two-sided crucifix above showing the tortured, then the risen Lord, an abstracted river of life in a terrazzo-patterned floor below and 15 striking murals (Stations of the Cross) between the dome’s 32 columns – and added to the whole effect of embracing the visitor spatially and spiritually. The chapel was wonderfully open, blending the interior with the green outside. Finally, the setting – a simple, green lawn rising gently from the road – completed the postcard-pretty scene.

A Priest, Four Artists & Two Engineers

Fr. John Delaney, the controversial but charismatic Jesuit chaplain assigned to the campus, orchestrated the project. National Artist for Architecture Leandro Locsin cut his teeth designing it. Dean Alfredo Juinio of the UP College of Engineering came up with the innovative thin-shell approach which a young David Consunji implemented to perfection using the simplest of machinery and lots of guts.

Finally, three cutting-edge artists – Napoleon Abueva, Arturo Luz and Vincente Manansala – created the crucifix, floor and murals respectively, which started them on the road to national artist status. (Another national artist, in music this time, Jose Maceda, would premier his concert "Pagsamba" there in 1968 and repeat it regularly in the same venue.) One renowned religious leader, four national artists and two giants in Philippine engineering and construction make for a really special structure …and a compelling story of how it got built.

The UP transferred to Diliman in 1949. It was meant to do so in 1942 as part of a massive transfer of civic structures that included a new capitol complex at the elliptical circle. The war intervened. Immediately after, the future campus was commandeered by the American Armed Forces as their headquarters. The two Juan Arellano-designed structures built in 1941 meant for the colleges of law and education became military offices. Around it rose dozens of quonset huts and a chapel of wood, galvanized iron roofing, bamboo and sawali that had a distinctive vernacular-inspired roof (my suspicion is that it was also Arellano-designed because of some references in the literature to his experimentation in pitch-roofed silhouettes for the state university’s architecture).

Unstable Architecture And A Troubled Up

That chapel deteriorated into stables towards the end of the UP’s military term. It was in shambles when Fr. Delaney found it but he quickly went to work to clean it up, aided by an ever growing flock of students, faculty and residents. After the patch-up, the UP chapel became the religious center of the campus. In the early ‘50s it was shared with the Protestant and Aglipayan congregations reflecting the open spirit of community in UP then.
UPSCANS In front of the Old Chapel after Mass with Fr. John Delaney. Fr John was my inspiration and hero at that time. His words and action still reverberates in my mind today!

The growing population of students and residents in the 493-hectare campus, however, took its toll and Fr. Delaney, as well as the Protestant church leaders, finally decided it was time to build new and separate chapels. Under UP president Vidal Tan, the campus also accommodated requests and allocated parcels in the non-academic north section of the university for both.

Those were trying years for Delaney, president Tan and the university. Issues of academic freedom, the threat of sectarianism (fueled by Fr. Delany’s extremely pro-active involvement in campus life and the growing political clout of the Delaney-mentored UP Student Catholic Action organization), and fraternity and sorority violence (which the chaplain tried his best to solve) made for a more complicated narrative, whose total complexion colored the entire decade.

It was in the middle of this maelstrom that the idea for the "saucer" started. In May 1954 the Protestant chapel was first to start construction. The modern structure, by university architect Cesar Concio, was completed a year later. The Protestant Chapel of the Risen Lord was funded by donations from America. The Catholic congregation was not so lucky and had to scrounge and scrape, egged on by the tireless Fr. Delaney to "give till it hurt." Fr. Delaney also did not want to sell out to corporate sponsorship or be beholden to endowments from the rich. Almost all of the P150,000 it took (remember, the peso was 2:1 back then) was raised by the UP congregation. Students missed their lunches and faculty donated portions of their salary to the fund. No wonder the chapel was named The Chapel of the Holy Sacrifice!


When It Rained, They Poured

This type of roof had never been built in the country. It took the ingenuity of Consunji to construct it within the constraints of the meager budget and the lack of equipment needed to pour the shell within the 18-hour window Junio set. The solution was ingenious and daring – four construction towers and a continuous ramp circling the structure allowed ordinary concrete mixers (churning out high-strength concrete) to supply a squad of workers in buggies rotating to pour the concrete.

The pour date was Aug. 25, 1955. It started to drizzle in the early morning and threatened to wreck the operation (the water would dilute the mix and weaken the concrete). But Fr. Delaney held a prayer vigil with UPSCANs taking turns asking for divine intervention. They got it as the site remained totally dry even as other parts of the large campus were drenched, even the University Theater, where the Nobel Prize winner for literature, William Faulkner, delivered a lecture.


The Chapel And Up’s Current Malaise

At four in the morning on Dec. 20, 1955 the chapel was blessed by Archbishop Rufino J. Santos. Fr. Delaney said the first mass (also the first Christmas mass) to an overflowing crowd. In his sermon, he thanked all those who made sacrifices to see that the chapel would be completed. The mood of the congregation was joyous and it spilled over to January only to be dashed by the news of Delaney’s death from a stroke. The sacrifices and trials he faced in the last few years had taken its toll. His body was brought from the Ateneo to the new chapel for the requiem mass, starting a tradition of honoring those of UP who had made a difference.
News of Fr Delaney death

The new chapel and the loss of their mentor only spurred UPSCANs to carry on their perceived mission of shaping campus life. In the years that followed they took political control of the student council stirring up a hornet’s nest of trouble that ended in the suspension of student political life in UP until a decision by the Supreme Court in the early ‘60s.

Personal Note: In 2009, my wife and I attended mass in the chapel during our annual vacation to the Philippines from US. I was also shock of the appearance and landscaping of the surrounding area, I started to cry, hiding my tears from wife.

My wife and I have pleasant memories of our participation in the UPSCA choir for three years under the leadership of the Late Professor Antonio Molina. I first met my wife in the old UP Chapel, through her uncle Fr. Constantino Nieva, who was President of UPSCA in 1952. In 1957, we got married and the decoration of our wedding cake was a 1:1000 miniature scale of the Chapel as shown below.




++++++++++++++++++++++++++++++++++++++++++++++++++++++
EPILOGUE:  2014 Personal Tour of the Teaching Building, Institute of Chemistry by Renan del Rosario

On May 7, 2014  Renan del Rosario, 1977 chemistry graduate and one of the advisers of the University of the Philippines Chemistry Alumni, Inc that year treated me with lunch and a personal tour of the new Institute of Chemistry Teaching Building at the UP Diliman National Science Complex. It was one of the highlights of my 90-day snow birding sojourn in the Philippines that year. I was able to take photographs of the Donor Wall which included my name(see photo above). 

 

The Donor Wall is right at the entrance of the building just by the side of the guard podium. The following are some of the photos I took that day. The day reminded me of my student and teaching days (1952 to 1959) at the College of Chemistry now known as the Institute of Chemistry. I was only 24 years old when I first taught chemistry to Pre-med, Nursing, and Engineering students in 1956. That was my first job after my Bachelor's degree graduation in October,1955.
,Outside the Teaching Building
At the Entrance

**About StoryWorth:

https://www.cnn.com/2021/04/27/cnn-underscored/storyworth-review/index.html

 

It is Spring Time-It is All About Flowers

 

Rafflesia Arnoldii: One of the two largest flowers in the world:Photo Credit-You Tube

Do you know what is the largest flower in the world? How about a list of the most expensive flowers? How about a list of top twelve most beautiful flowers in the world. According to the recent article here are the twelve most beautiful flowers in the world. Passion Flower, Gazanias, Plumerias, Dahlias, orchids, tulips, calla lilies, water lilies, clematis, magnolias, Bird of Paradise and Roses. 

 

All the above twelve most beautiful flowers with the exception of the water lily , I have grown and cultivated in my gardens in the Philippines ( Chateau Du Mer, Marindque) and also here in US ( Bay Area, Sacramento Area, Central Valley of California, Kansas City, Missouri and Silver Spring, MD). 

Not in the top twelve list, the flowers that I have cultivated are Camelias, Peonies, Hibiscus,  Bougainvillas, Hydrangeas, Geraniums, Azelias, Rhodondendrons and Begonias.

Here's a video of the largest flower in the world- Rafflesia arnoldii.

Here are 3 videos for the most expensive flowers in the world

Meanwhile enjoy this photo of my Clematis, Azeleas and Peonies in the Front Yard of our Residence in Silver Spring, MD, 1994

and some of my orchids in the Philippines in the Gardens of Chateau Du Mer

 

 

My Youngest Sister Collection of Ornamental and Foliage Plants in the Philippines

A part of My Sister's Collection on the Front and Side Yard of her Residence

One of the best and healthful hobbies is container gardening. My youngest sister in the Philippines started her container plants collection(foliage plants) last year. 

In her collections are several varieties of philodendrons, coleus, ferns, orchids, caladiums, euphorbias, begonias and other rare and popular foliage plants of the Philippines.   

Here are some photographs of her collection of plants. In the Philippines, they are grown outside but here in the US they are grown as house plants ( inside) or in the Greenhouse except in Southern Florida and maybe San Diego, CA which has tropical climate similar to the Philippines. Enjoy these photos.   

 

 

 

Meanwhile here are two photos of my geranium growing outside in my front yard and my orchids in the living room of my residence here in Northern California

 

For more information on foliage plants and varieties of philodendrons visit:

https://www.gardendesign.com/plants/foliage.html

https://smartgardenguide.com/philodendron-varieties/ 

 

Dungeness Crab and Manila Clams for Our Easter Dinner This Year

Ditas and I are both excited at the above purchase!
 

Ditas went to her nearby Sea Food Market( Sunh) today to buy some Manila Clams. Luckily, live dungeness crabs for only $12.99/lb were also available.  This is not bad a price since I had been comparing prices for steamed Dungeness Crabs in our local grocery stores. The price ranges from $12.99 to $16.99 per pound depending on the grocery store. I had also been pricing whole cooked Dungeness crab with spices at our local seafood restaurants. The price ranges from $35 to $50 for one crab.  For more details about Dungeness Crabs visit the following site:

https://myfavoritepinoydishes.blogspot.com/2014/03/what-did-i-do-to-deserve-this.html

Meanwhile here are the photos of the cooked Dungeness crab, the Manila Clams and our Easter Eggs. 

Again, Have a Blessed Easter to All!!!

 

My Two Favorite Recipes for Easter and Other Special Occasions

 Happy Easter to ALL!!!!!

Photo Credit: Panlasang Pinoy.com

Two of my favorite Pinoy Dishes during Easter, Christmas and other special occasions are Relleno na Bangus (milk fish) and Chicken Relleno. In our younger years Macrine( RIP) would cook either Relleno Bangus or Chicken Relleno for our Easter Dinner. In the Philippines she had the assistance of our regular cook, but here in the US she had me as the errand or chopping boy. I enjoyed watching her cooked the Rellenos. The recipes are not  that hard but the Deboning Process required skills, practice and special tools. Here are the videos for your viewing pleasure.

   And for the Chicken Relleno

Meanwhile enjoy some spring blooms from my garden here in Northern California.  Again, Happy Easter to All!!

 

 

I Tasted Blue Rice for the First Time the Other Day

Spicy Pompano (Whole Fish)-Sautéed deep fried Pompano with onions, green beans, red bell pepper, jalapeño, zucchini, basil, garlic, chili sauce, and topped with crispy kaffir lime leaf.

 

I ordered Blue Rice from a Thai Restaurant the other day along with fried and Spicy Pompano. It was my first time to taste blue rice. The taste is similar to the regular Steam Jasmine white rice. Below is a description of what blue rice is      

https://timesofindia.indiatimes.com/life-style/food-news/blue-rice-is-the-latest-craze-that-is-insta-worthy-too/articleshow/80313239.cms

While Blue Rice is not new to Asian cuisine, it is the striking colour that has made people sit up and take notice of the dish lately. Recently, even actress Jacqueline Fernandez was seen indulging in this dish along with her friends. Blue Rice, also known as Nasi Kerabu, is prepared using butterfly pea flower and is commonly consumed in Malaysia and Thailand. Though mixologists across the country have previously used butterfly pea flowers to impart blue or purple colour to drinks, it is only recently that blue rice has been introduced in restaurants in the city. Chef Tarun Sibal, who serves Blue Rice with Yellow Tofu curry at his eatery, shares:

How to prepare it
Take a cup of Jasmine rice and cook it like you prepare regular white rice. To the water add a handful of butterfly pea flower. “You will need a lot of blue pea flower so that the rice gets the blue colour,” he says.
Pair it best with
This rice can go with all kinds of curries. “Since it is fragrant rice, personally, I prefer to pair it with Asian flavours. So, an Asian curry with mild flavour is definitely a good choice,” he adds. 

Nutrition aspect
Butterfly pea flower is packed with anti-oxidants and is said to detoxify your body and enriches skin texture as well.

 

 

Personal Note: Rice Farming and its income made me of what I am today. My Parents and Grand Parents from Iloilo were Rice Growers and Landowners during their time. My Parents had more than 30 tenants planting rice annually in Barotac Viejo. It was our primary income. 

On the other hand, Macrine's (RIP) Dad in the island of Marinduque was a coconut grower and copra dealer( coconut plantation). Macrine's Mom was an Educator! My own Mother was a full time homemaker. My Dad on the other hand was a Dentist in his younger years. Later on he retired from Dentistry and helped my Mom managed our farm land and other properties, including a commercial building in Iloilo City.  

 

 

Ludong-The Most Expensive Fish in the Philippines

Recently, my relatives in the Philippines and I had a conversation about the most expensive fish in the Philippines. I did some Internet search and here's what I learned.

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.

For details read:

https://davidbkatague.blogspot.com/search?q=ludong

Meanwhile, enjoy these photos of the sand mullet- a poor cousin of Ludong, which is more abundant and cheap. Photo Credit: Aida Largado Peevers

Sand Mullet grilled and wrapped with banana Leaves-look yummy! 

 

Blue Rice and Fried Pompano I ordered via DoorDash today

and last but not least a photo of the largest anthropods coconut crab-in Marinduque

For a list of top-10 best tasting wild fish read:

 

 https://www.outdoorhub.com/stories/2018/07/24/10-best-tasting-wild-fish-according-internet/

 

Also enjoy this video -the top ten Island Dream Destination in the Philippines

https://www.youtube.com/watch?v=zYWj-ly7nR8 

 

 

Remembering Macrine J Katague through her Community Involvement here in the US and also in the Philippines

Today March 26, 2021, would have been Macrine's 85th Birthday. A video of her last year video taken by her Care Taker, I shared in my FB page today also. Macrine passed away last August 10, 2020. She had lived a good life for she had touched many other lives through her community involvement here in the US as well as in the Philippines.  

This post is to remember Macrine(RIP) in her community involvement during her productive and well-lived life here in the US as well as in the Philippines.

The three awards are Macrine's involvement with Marinduque International, Inc and the Marinduque Association of the Capital Area. For details read:

https://hubpages.com/politics/medical-mission-of-love-to-marinduque
 

Macrine was actively involved with Filipino-American community in the tri-state area of Maryland, Virginia and Washington, DC. SHE was also active with the Marinduquenos of the Capital Area (MACA). Some of MACA's projects were giving scholarships to needy students in PI. We also collaborated with the humanitarian projects of “ Feed the Hungry, Inc”in Marinduque. In 1998, we participated in the medical mission to Marinduque. We donated 100 used eyeglasses, medical supplies and equipments to the local hospital. In May, 2001 we again participated in the medical mission sponsored by Marinduque International,Inc.. I helped in the distribution of drugs and served as acting treasurer during the mission week, while Macrine was Executive Director of the organization.

Macrine short biography was published in MI, Inc Newsletter when she was elected President in 2003 as follows. "Macrine was born in Boac and a product of the Immaculate Conception Academy High School. She obtained her Bachelor in Business Administration degree in 1957 from the University of Santo Tomas. Two month after graduation she married her college sweetheart, David Katague from Iloilo, who was then teaching chemistry at UP Diliman. They immigrated to the US in 1960.

Macrine stayed home for 18 years raising her four children but decided to go back to nursing school in California. In 1979, she received her Bachelor of Science degree from Holy Name College in Oakland, CA. as well as a Certificate in Public Health Nursing specializing with Spanish speaking patients.
 

In 1990, Macrine and David moved to Maryland where she worked for nine years as Quality Improvement Nurse for several home health organizations in the Washington, DC area. It was then, when she joined the Marinduqueno Association of the Capital Area (MACA) and became an active member of the association. She retired in 1998 and got involved with the Filipino-American organizations in the DC metropolitan area".

In June, 1999, Macrine was elected overall chairperson of the Festival Committee that was in charge of the celebration of Philippines Independence for the whole month of June. An article was published by the Manila Mail, dated June 15, 1999. An excerpt of the news article written by Bing C. Branigin reads:

RP TAKES CENTER STAGE-45 GROUPS JOIN PARADE IN D.C.

“A big crowd watched the Philippines took center stage when Filipino-Americans stage a colorful parade, fair and cultural show along historic Pennsylvania Avenue on June 6.

Filipino Americans display their pride in their culture and heritage to mark the 101st anniversary of independence from Spain and more than a century of Philippines- American relations.

More than 45 Filipino- American organizations participated in the parade and whole day fair and cultural shows. They are groups from Washington, D.C., Maryland, Northern Virginia, South Carolina and the 40 strong Ati-atihan group from Virginia Beach.

The Marinduquenos who are this year hosts, showed their Moriones, clad in colorful costumes and mask.

Macrine Katague, Philippine Festival chairperson, said she was really impressed by the number of groups who participated. For the last six months, the Philippine Committee had been meeting regularly to make this year's event better.

A group of twenty food vendors sold favorite Philippine dishes, like lechon, pancit etc...For drinks, there was San Miguel beer, sago at gulaman, coconut juice and halo-halo. There were also twenty tents filled with dry goods, like T-shirts, jewelry, gift items, travel agencies and phone cards. One of the highlights of the fair was on-the-spot painting contest for the kids. The Philippine Embassy displayed stamp collection, fabrics and handicraft from the Philippines

Ambassador and Mrs Raul Rabe, patiently stayed at the Fair from 9:00AM to 6:00PM, enjoying all the activities. Rabe will end his term the end of this month. He will be replaced by Ambassador Ernesto Maceda.

Mr. Rabe told Manila Mail “ This is a great thing that we are celebrating our independence here in Pennsylvania Avenue. I noticed that every year we are getting better and bigger,. Hopefully we will keep the momentum going”..

To show their support to their “kababayans”, Marinduquenos from New Jersey came to town. Al Molato who represented the Eastern Seaboard Marinduqueno said, “ This is fantastic, imagine our small island is so small and taking a big role in the capital to host a big endeavor like this. I would like to salute my co-marinduquenos and Macrine Katague the chairperson, for a wonderful job.”

Meanwhile, enjoy this photo of Macrine during our trip to London at Wembley Stadium watching the Football Game between the Redskins and 49'ers.