IPR and Medicines 31: Trademark Stealing and Counterfeit Medicines

Today, I will attend the 1st day of National Consciousness Week against Counterfeit Medicines, Theme: Kapakanan ng Pamilya Alagaan, Huwad na Gamot Labanan, to be held at the JY Campos Hall, Bayanihan Center, Unilab Complex in Pasig City. The event is sponsored by the Food and Drugs Administration (FDA) and today's event is mainly for civil society organizations (CSOs), including Minimal Government Thinkers, Inc.

Production of counterfeit, fake and substandard medicines is generally stealing the trademark and logo of famous pharma companies, both innovators like Pfizer and GSK, and generics like Unilab, then selling those fakes. Patients and their family/guardians think that they are buying the real products of these known companies and the patients end up getting some adverse side effects, or they don't get cured and the disease in their body mutate or expand into something more serious. So counterfeits is costly in terms of expanding the treatment, and can be fatal.

As an advocate of rule of law as the main function of government, I believe that government, both national and local units, should be serious in fighting this crime because it endangers public health. This is a more useful function that imposing drug price control and mandatory, forced priced discounts for senior citizens and perons with disabilities (PWDs). Of what use to certain sectors are cheap, forcibly discounted medicines, if they some of them are fake and substandard and  hence, can cause more health problems? Declining prices of  medicines and healthcare can be done by having more competition among more pharma players, among drugstores and hospitals, among physicians and other health professionals.

The topics and speakers for today's event are:

1. Keynote Address by DOH Assistant Secretary, Atty. Nicolas Lutero, OIC of the FDA.

2. "Global Perspectives on Counterfeiting Medicines and the Current WHO Initiatives on SSFFC" by Mr. Michael Deats, Group Lead, SSFFC Medical Products Safety and Vigilance Essential Medicines and Health Products, WHO, Geneva, Switzerland

3. "A Multistakeholder Approach to Strengthening Community Advocacy for Safe and Quality Medicines (Highlights of the MeTA Discussion Series)" by Ms. Cecilia C.  Sison, Country Coordinator, Medicines Transparency Alliance (MeTA) Philippines

4. "Impact of counterfeit medicines to public health and patient safety" by Dr. Maria Minerva P. Calimag, President of the Philippine Medical Association (PMA)

5. "Counterfeiting and its impact to national security and public safety" by Mr. Eric McCloughlin, Deputy Attaché, Homeland Security Investigations, U.S. Immigration and Customs Enforcement (ICE), US Embassy in Manila

6. "Understanding the problem and working together to combat counterfeit medicines" by Mr. Samson Chiu, Director, Asia-Pacific Region, Pharmaceutical Security Institute (PSI)

7. "Food and Drug Administration process and initiatives in combatting counterfeit medicines" by Ms. Maria Lourdes C. Santiago, OIC, Center for Drug Regulation and Research

8. "Enforcement Policies and Regulations on Medicines Anti-Counterfeiting" by Atty. Edna Valenzuela, Senior Assistant State Prosecutor, Department of Justice (DOJ)

9. "Initiatives of Intellectual Property Office of the Philippines in combatting counterfeit medicines" by Atty. Ricardo Blancaflor, Director General, Intellectual Property Office of the Philippines (IPO)

10. Industry’s effort in combatting counterfeit medicines proliferation: 

Best Practices in private industry enforcement programs to stop counterfeit medicines from endangering public

a. Mr. Tetsuda Ikeda, Director Global Security, Asia Pacific Region, Pfizer, Inc.

b. Mr. Teodoro Padilla, Executive Director, Pharmaceutical Healthcare Association of the Philippines (PHAP)

c. Ms. Dolora P. Cardinal, Head, Public Affairs Committee-FDA, Philippine Chamber of the Pharmaceutical Industry, Inc. (PCPI)

Closing remarks by Dr. Ariel I. Valencia, FDA Deputy Director General for Field Regulatory Operations

On the 2nd day tomorrow, the same speakers from the WHO, PSI, US Embassy, others, to be held at Diamond Hotel, Roxas Blvd, Manila. Target audience are mostly government enforcement agencies. And the 3rd day on Wednesday, it will be a pledging session by various groups at the FDA office in Alabang, Muntinlupa.

Meanwhile, some materials on counterfeit medicines I found several years ago:

1. Coalition Against Fake Medicines Launched

The medicines we take for day-to-day ailments and life-threatening conditions should make us feel better or save our lives. But because of the presence of counterfeit medicines in the country today, we should be cautious as to the medicines we buy.

This was the warning issued by the Department of Health (DOH), which noted that about ten percent of medicines bought in pharmacies today are fakes. Fake medicines, which are not registered with the Bureau of Food and Drugs, may be useless, harmful, or even deadly.

This dangerously widespread occurrence pushed similarly-minded government agencies, and private institutions to form a coalition group to help combat and eventually eliminate this illegal trade. The Coalition Against Fake Medicines is composed of ten organizations - the Department of Health (DOH), Department of Trade and Industry (DTI), Department of Justice (DOJ), Philippine Medical Association (PMA), Drugstores Association of the Philippines (DSAP), Mercury Drug Corporation, Zuellig Pharma Corporation, GMA 7 Broadcast Network, Philippine Daily Inquirer and Pfizer. Inc..

Present during the MOA signing were (standing from left): Manuel Quiogue, President, GMA 7 Network, Inc.; Celine Madamba, AVP-Strategic Marketing Communications, PDI; Jack Concepcion, VP-Merchandising, Mercury Drug, Inc; Dr. Jose Sabili, Vice President, Philippine Medical Association. 

Seated from left are Celia Carlos, President, Drugstores Association of the Philippines; Hon. J. Norman Jocson, Assistant Secretary, Department of Trade and Industry; Hon. Manuel Dayrit, Secretary, Department of Health; Rey Gerardo Bacarro, President and Country Manager, Pfizer, Inc; Hon. Macabangkit Lanto, Undersecretary, Department of Justice; and Michael Becker, President and CEO, Zuellig Pharma Corporation.

2. From The News Today, 2006.

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See also:
IPR and Medicines 27: More on Glivec and India's SC Decision, April 02, 2013
IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking, April 06, 2013
IPR and Medicines 29: Parallel Importation and Patent Linkage, August 19, 2014
IPR and Medicines 30: R&D and Innovator Companies, November 03, 2014

ETHIKOS 1: MeTA-PH, PCPI, PHAP and FDA on launching

(Note: This is an expanded version of the paper that I wrote last Friday.)

Last Thursday night, the ETHIKOS (Ethics in Healthcare) Movement was launched at C3 Events Place in Greenhills, San Juan, Metro Manila. Many participants from different groups and sectors. Some quotes from some speakers that night.

All photos I got from the MeTA Philippines facebook page. Thanks Ian Nuevo.

1. Former Gov. Roberto “Obet” Pagdanganan, MeTA Philippines Chairman

Gov. Obet thanked the participants, particularly the organizations that formed movement – the Medicines Transparency Alliance (MeTA) Philippines, the Coalition for Health Advocacy and Transparency (CHAT), and the British Embassy’s Foreign and Commonwealth Office (FCO).

Then he introduced the Convenor Group of the ETHIKOS Movement: (1) Princess Nemenzo of WomanHealth, (2) Celia Carlos of the Drugstores Association of the Philippines (DSAP), (3) Girlie Lorenzo of Kythe Foundation, also of the Philippine alliance for Patient Organizations (PAPO); Tony Leachon of the Philippine College of Physicians (PCP), and himself.

He discussed what ETHIKOS is – a movement to encourage ethics in delivering healthcare to the patients, ethics in dealing with healthcare professionals  and other private players in the sector, ethics in government.

2. Atty. Dave Escalona, Philippine Chamber of Pharmaceutical Industry (PCPI) and United Laboratories

Dave said that the local pharma industry is supporting the Mexico City Principles (MCP) for voluntary codes of business ethics in the biopharmaceutical sector. He introduced a similar term, “Manila Principles” where the basis of such code of ethics are the Generics Act of 1998 and the Cheaper Medicines Law of 2008 (RA 9502), and the object of such ethics is the welfare of the patients.

Thus, the Manila Principles should consider TRIPS flexibilities as contained in RA 9502, avoid whenever possible prolonged data exclusivity, disallow frivolous patents, allow early working of soon-expiring patents of innovator drugs. He lamented that many local pharma companies are small and lesser known compared to big multinational pharma.

3. Teodoro “Ted” Padilla, Pharmaceutical and Healthcare Association of the Philippines (PHAP) Executive Director.

Ted narrated that in 1993, the association introduced and adopted a code of ethics called the PHAP Code of Practice. He quoted the late Doc Alberto “Quasi” Romualdez (a former DOH Secretary, founding chairman of MeTA PH) who said that “The most important achievement of PHAP now is that they have made ethical behaviour an import part of their commitment…”

He emphasized that no amount of health reform will be truly universal if people and players ignore the consequences of unethical behaviour. He also expressed support for the FDA to implement the MCP. Then he mentioned the important role of the innovator companies for endlessly producing new medicines which help save lives and improve the quality of life of Filipinos.

4. Kenneth “Ken” Hartigan Go, Food and Drug Administration (FDA) Director-General.

Doc Ken discussed certain FDA guidelines regarding senior government officials (SGOs) who make follow up calls at FDA. There are four possibilities where SGOs:

(a)     to inquire on behalf of his/her private sector associates, or determine the status of a rival company

(b)     to request earlier facilitationof application (expediting or jumping the queue

(c)     to demand aprovals even if the license or product registration is to be denied, or to demand a denial against a rival company, and

(d)     to reverse a regulatory decision.

My comments to some of these points in my next article about ETHIKOS..

MeTA 16: Day 1 of Conference 2014

The 2014 Medicines Transparency Alliance (MeTA) Philippines forum 2014 started today, here at the Bayanihan Center of Unilab Complex, Pasig City, Metro Manila. Attendance is big, 100+ people attending. I see many new faces here compared to past MeTA PH fora.

Below, they key speakers, from left: Former Bulacan Gov. Roberto "Obet" Pagdanganan, MeTA Philippines Chairman, gave the Opening Remarks. Dr. Tim Reed, Health Action International (HAI, Amsterdam, the International MeTA Secretariat). Dr. Deirdre Dimancesco of WHO in Geneva, and Dr. Francisco Tranquilino of the UP College of Medicine, also Chairman of the Ethics Committee, Philippine College of Physicians (PCP). He gave the Keynote Speech. 

In his brief speech, Dr. Tim Reed noted that "Multistakeholder engagement is clearly achieved in this forum" as the participants come from different sectors and agencies -- government, corporate and industry players, and civil society organization. 

Dr. Art Catli of the Pharmaceutical and Healthcare Association of the Philippines (PHAP) introduced Dr. Tranquilino. Said that the latter is a very popular, well-sought speaker, giving countless speeches here and abroad; that he is a "terror" teacher at UP; a workshorse, a researcher who has published dozens of academic articles, an ambassador of good will. 

Dr. Tranquilino disclosed his past and present engagement in the pharma industry, most of which were with the innovator companies. He started discussing "striking a balance" between innovation and government regulations. 

Medicines save lives, but developing new medicines now take 11-15 years out of 20 years total patent period. Many compounds that were originally discovered and were patented do NOT become medicines, if they do not pass the various clinical trials for safety, efficacy and other criteria. In the last decade, there was dying of pipelines of new revolutionary drugs, resulting in more mergers and consolidation of big pharma companies.  

The Mexico City Principles (MCP) for voluntary codes of ethics of businesses especially in biopharmaceutical sector was adopted by APEC member countries to help reduce corruption, bribery, and at the same time protect public health. 

The next session was on “Multistakeholder advocacy for adherence to the MCP”. The speakers were, from left: Tomas Marcelo "Beau" Agana, Past President of the Philippine Chamber of Pharmaceutical Industry (PCPI), the federation of domestic or national pharma manufacturers and drugstores; Teodoro "Ted" Padilla, Executive Director of PHAP; Atty. Florina Agtarap of the Department of Justice (DOJ) Office of Competition; Dr. C. Diza of the Food and Drugs Administration (FDA); and Dr. Melissa Guerrero of DOH National Center for Pharmaceutical Access and Management (NCPAM). Moderator was Yolanda Ibarle, MeTA Project Director.

Dr. Guerrero said that there are ethical issues in government processes, they have to address those upfront. She hopes that MeTA Philippines and its multi-stakeholder partners can help the DOH urge the local government units (LGUs) abide by DOH rules on the selection of suppliers, truthful procurement of medicines.

Dr. Diza said that FDA will hopefully develop guidelines or an Administrative Order (AO) specifying what needs to be followed from the MCP.

Beau Agana of PCPI talked about their draft Code of Ethics, an APEC workshop for voluntary code of ethics in 2012. Relationship building becomes problematic in pharmaceutical marketing under information asymmetry condition, he said. Code of Ethics will temper maximizing personal interest of doctors and other 3rd party decision makers, and prioritize patients' interests. He added that  patients have started to turn to pharmacists, not their doctors, in their medicines purchase. 

Ted Padilla of PHAP said that they have their Code of Ethics early, that penalties are imposed on  violating member firms and personel. Monetary sanction, a fine, is more effective in tightening behavior. Transparency is essential, there is no substitute to being transparent and honest, and medical decisions must always be made with the best interest of the patients, he added.

During the open forum, some concerns were raised regarding the procurement process and practices of LGUs, not only of medicines but also medical supplies, equipment and facilities.

My main concern in being involved in topics like this is how civil society and voluntary organizations will have greater role in promoting transparency and competition in the economy. Very often, self-regulation by industry players themselves are better than government regulations, restrictions and politics. Manufacturers, wholesalers and retailers who sell only good quality products because they have concern for their customers, or because they are scared that they will be scandalized if their products are discovered to be unsafe and/or ineffective. 

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See also:
Health Transparency 12: MeTA Philippines Dynamism, October 02, 2012 
Health Transparency 13: MeTA International Visit to Manila, April 16, 2013 
Health Transparency 14: IMS-CHAT Meeting, April 18, 2013, Friday, July 12, 2013 
MeTA 15: Forum 2014 on Healthcare Ethics and Transparency, January 30, 2014

MeTA 15: Forum 2014 on Healthcare Ethics and Transparency

The Medicines Transparency Alliance (MeTA) Philippines will hold its annual forum this year with a timely theme, Transparency and Ethics in Healthcare. Things that are expected of various players and professionals in the health sector -- pharma companies, drugstores and pharmacies, hospitals and clinics, doctors and pharmacists, etc. And patients and the public too, we should have our own "code of ethics".

Here is the provisional program as of January 25. I removed the time slots to focus on topics and speakers. Lunch time is indicated, so readers can see which ones are morning and afternoon sessions.

The Mexico City Principles (MCP) is a set of ethical conduct adopted by APEC member countries for the pharmaceutical sub-sector several years ago, held in Mexico City. As shown in the program above, there will be a high-level multistakeholder panel discussion on the adoption of MCP in the Philippines and a call for voluntary codes of business ethics from different sectors and players. 

Day 2 morning, there will be foreign speakers who will talk about global developments in regulating medicines promotion (Tim Reed, Executive Director, HAI Global), regional trends in ensuring transparency in pharmaceuticals policy (Klara Tisocki, Team Leader-Essential Medicines and Health Technology, WPRO), and the way forward for the Good Governance for Medicines (GGM) Program (Deirdre Dimancesco, WHO Geneva). 

In the afternoon, two special topics that have great impact on healthcare in the Philippines - health promotion and sustainable funding, will be discussed by speakers from  HealthJustice  and the AIM.

Participants will come from various sectors and represent all stakeholders in the dialogue about health, medicines and transparency.  They will have opportunities throughout the forum to participate in open forums, ask questions and articulate their positions and perspectives through the stakeholder workshop.

They will be given links to all forum documents, including studies and researches cited in the presentations, as well as reference materials on transparency, ethics in health, addressing corruption in health and related topics.

Meanwhile, I have changed the title of this thread from "Health Transprency" to simply "MeTA" as this thread is mainly about MeTA fora and activities.
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See also:
Health Transparency 11: MeTA Philippines and Multistakeholder Process, September 19, 2012 
Health Transparency 12: MeTA Philippines Dynamism, October 02, 2012 
Health Transparency 13: MeTA International Visit to Manila, April 16, 2013 
Health Transparency 14: IMS-CHAT Meeting, April 18, 2013, Friday, July 12, 2013 

Drug Price Control 36: Advisory Council, James Auste and China, July 12, 2013 
FDA 6: Business and Modernization Plan, July 17, 2013

UHC 16: Dialogue on UHC and Medicine Access, AIM July 25-26

The Department of Health (DOH), Philippine Health Insurance Corporation (PHIC or PhilHealth), FDA and the AIM Dr. Stephen Zuellig Center for Asian Business Transformation (AIM ZCABT) will hold a policy dialogue tomorrow and on Friday, on “Universal Health Care and Access to Medicine” at the Asian Institute of Management (AIM), Makati City.

I received the invite only today when the DOH National Center for Pharmaceutical Access and Management (NCPAM) extended the invite to all members of the DOH Advisory Council for the Implementation of RA 9502 (Cheaper Medicines Law of 2008). Thanks to Mhyanne Dioso, the chief “workhose” of NCPAM for the Advisory Council, aside from NCPAM Director, Doc Virgie Ala.

The main objective of the seminar is “to identify the gaps and solutions in ensuring universal access to medicines in the Philippines” and hence, contribute to attaining universal health care (UHC) or Kalusugan Pangkalahatan.

The DOH’s budget has been rising big time in recent years: from only P18.9 billion in 2008, marginally rising to P23.7 billion in 2009 and P24.6 billion in 2010. When the PNoy Aquino government came, the DOH budget jumped to P31.8 billion in 2011, P42.1 billion in 2012, to P52 billion this year. Next year, the DBM-approved budget that was sent to Congress is P87 billion, or a P35 billion jump over this year’s budget.

A big portion of such huge jump in the proposed spending next year will be used to cover more poor households in PhilHealth insurance system, as the President said in his State of the Nation Address (SONA) last Monday. And medicine procurement by DOH hospitals and other agencies will likely get a big boost too.

Please note that public health spending in this country does not only come from the DOH. There are also the LGUs through their provincial, city and district hospitals, provincial and city/municipal/barangay health centers. Then other government agencies like the AFP Hospital, Veterans (under the DND) hospital, PNP Hospital, UP-PGH, PCSO ambulances and health charities, and so on. And almost all departments and agencies have their own in-house clinics for the healthcare of their employees and their dependents. There is huge public spending in healthcare and many people do not realize it, so they ask for more subsidies through the DOH and PhilHealth.

Back to the forum tomorrow. Among the speakers will be DOH Secretary Enrique T. Ona, DOH UnderSec. Madeleine “Madz” Valera, PhilHealth President and CEO Alexander “Alex” Padilla, FDA Dir.- General Kenneth Hartigan-Go, and Mr. Deejay Sanqui of IMS Health.

I hope that Sec. Ona will give an overview of the big DOH budget next year seeking approval by Congress. It seems that the “creeping re-centralization” of healthcare is no longer creeping but already hopping. Healthcare is among those functions by the national government that were devolved and decentralized to the LGUs under the Local Government Code of 1991.

I also hope that PhilHealth President Alex will not announce another round of hike in annual premium, especially for those in the formal sector. PhilHealth hiked plans to hike the premium from 2.5 to 3.0 percent of the basic salary of those working in the formal sector just a few years ago. The premium of OFWs has been raised from P900 to P1,200 per year and the sponsored program, the poor, from P1,200 to P2,400 per year, but the poor do not pay this amount, the LGUs and/or the DOH do.

My advocacy for minimal government in healthcare does not include healthcare for pediatric diseases and infectious diseases for both children and adults. I support further DOH and LGUs spending for these two types of diseases. But I do not support more government subsidy for NCDs for adults. If people have money to buy lots of fatty/salty food and drinks, lots of alcohol and tobacco products, or nice flat tv and DVD players and become couched potatoes, and they become sickly later, they should also have the money to buy private health insurance to augment their PhilHealth insurance. To say that they have no money for their own healthcare while they can spend for those food, drinks and smoking, is simply “palusot” and must be checked.

PhilHealth I think, should prioritize issuing automatic membership card for all poor children, say 6 years old and below. If DOH and LGU resources cannot support automatic coverage for older children and parents from poor households, then other agencies like DSWD, PCSO, UP PGH, private charities and foundations can come in. But usually LGU hospitals provide universal coverage for their local residents, young and old alike.

Tomorrow afternoon panel discussion will be on “Innovating and Improving Access to Medicine via Good Governance” with Tarlac Gov. Victor Yap, Gov. Alfonso B. Umali, Jr. of ULAP, Ms. Esther Go of Medilink, and Dr. Peter Glen Chua of FDA as speakers.

The role of LGUs is important in this aspect as lots of waste if not corruption in medicine procurement and distribution happen at the LGUs level. Many LGUs do not have the proper training and expertise in the proper storage and dispensation of medicines given free to their local residents.  

On Day 2, July 26, there will be a panel discussion on “4Ps of Financing Pharmaceuticals”: Rational Pricing, Tailored Procurement, Strategic Purchasing, and Risk Pooling, with four speakers:

Dr. Melissa Guerrero of DOH-NCPAM, Mr. Bienvenido Bautista of PITC Pharma, Inc., Dr. Dennis Ross-Degnan of Harvard Medical School, and Dir. Carlos Da Silva of AHMOPI.

NCPAM has a big budget for medicine procurement for “drugs entitlement” on certain diseases like breast cancer. PITC Pharma is the state’s chief drug importer and wholesaler for the various DOH-sponsored Botika ng Bayan, Botika ng Barangay, and other DOH agencies.

I am curious about the lectures on various topics like the ASEAN Pharma Harmonization, Anti-Microbial Resistance (AMR), Drug Price Referencing, PPP to Improve Access to Medicine, and PHIC and PCB 2. The  speakers will be Ms. Joyce Cirunay of FDA, Dir. Virginia Ala of DOH-NCPAM, Mr. Alex Haasis of NCPAM, Dr. Anthony Faraon of Improving Access to Medicine Project, and Dr. Francisco Soria of PHIC.

We shall have an ASEAN Economic Community (AEC) in 2015 or less than two years from now. The ASEAN Free Trade Area (AFTA) will mature, meaning zero tariff for all imports from any ASEAN member-countries, except perhaps for poorer economies Myanmar, Cambodia and Laos who might slap import tariff on some imported products from other ASEAN countries.

Singapore is the regional headquarter of many innovator pharma companies, not only because it is a regional financial center at par with Hong Kong, but also it strictly respects IPR like patent and trademark. Thus, IPR-busting policies like compulsory licensing of new and patented medicines, and drug price control are not done there. An ASEAN harmonization plan will consider this disparity in IPR and drug pricing policy. Many ASEAN countries like the Philippines, Thailand, Indonesia, Malaysia and Vietnam have laws allowing CL or similar schemes, and drug price control policy. Singapore does not have such policies.

Another learning experience for me in the next two days in health economics and public policy.

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See also:

Socialized Healthcare 12: Nurses, Doctors and Other Resources, March 03, 2013

Socialized Healthcare 13: On Inequality and Inclusive Business in HC, March 19, 2012  

Socialized Healthcare 14: Over-extending Government Role in Health, May 22, 2013 

UHC 15: On DOH Plan to Recentralize Healthcare, June 27, 2013

Rule of Law 21: Fake Stem Cell Therapy and Fake Drugs

* This is my article today in thelobbyist.biz.
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The recent stem cell scandal in the Philippines is another proof that many government agencies are getting busy with so many functions and expectations, spreading their resources thinly, and become distracted if not blinded in implementing what should be their primary mandate.

The Department of Health (DOH) and the Food and Drugs Administration (FDA) are busy with various concerns including those that are better left to the private sector and civil society. And that is how fake – or at least unlicensed and unregistered -- health professionals and medical practices, fake or substandard medicines, untruthful ads on other health products and food supplements, are able to proliferate.

Top of Form

These are products and services that can be fatal to patients, and both the DOH and FDA seem to be weak on this. Concerns like monitoring and implementing politics-driven policies like drug price control, penalizing small drugstores that cannot upload the electronic drug price monitoring system (EDPMS), can distract them from more important function of going after those fakes.

The old controversy on stem cell therapy was once again highlighted when the Chairman of the Dangerous Drugs Board (DDB), Antonio “Bebot” Villar, went public to complain that after undergoing the treatment to improve his condition – weak body, pain in the bones – the opposite happened. He suffered more difficulty in walking after such treatment.

The stem cell "therapy" was (a) done by foreign physicians (German and Thai) assisted by two Thai nurses, and (b) venue was not a health facility but a hotel, Edsa Shangrila Hotel, done last June 9, 2012. He paid Euros 16,000 for that treatment that produced nothing or even worsened his condition.

Foreign physicians – and many other professionals – cannot practice in the Philippines because of the ban provided in the Philippine constitution. This is one ugly aspect of our charter that needs to be amended and removed. That is why those foreign or non-accredited physicians are doing their practices inside hotels or mountain resorts or spas, where they can hardly be noticed by some government regulatory agencies.

I attended the media briefing by the Philippine Medical Assocaition (PMA) at Rembrandt Hotel last Thursday morning, hosted by the Liga ng mga Brodkasters ng Pilipinas Inc. (LBPI). PMA President, Dr. Leo Olarte said that such  treatment is generally safe if (a) done by accredited physicians, and (b) stem cells should come only from humans, from the patient him/herself especially, and NOT from animals, plants, fetus or embryos of dead babies. He suggested that perhaps what those foreign physicians may have given DDB Chairman Villar was just dextrose or ordinary water.

Mr.  Villar put himself in public ridicule because he dealt with those two abnormal circumstances. But  his act of coming out to warn the public against fake stem cell treatment is good and commendable.

There are crooks and opportunists everywhere, poor and rich countries alike. That is why it is important that the main function of the government is to promulgate the rule of law. Strictly implement laws against stealing, murder, abduction, counterfeiting, etc. When government moves into the function of endless redistribution of income and assets, the primary function is often neglected. And that is where criminals strike, they know that government is busy somewhere else.

Like when our policemen are busy flagging down motorcycle drivers without helmets, or their helmets do not bear DTI sticker; or flagging down color-coding cars, or "colorum"vans that transport office workers to their residential areas. When policemen are busy with these shallow and often extortionary concerns, the real criminals -- thieves, pickpockets, murderers, carnappers, kidnappers, etc. -- are relatively free to do their work.

In one report in rappler, it said, "The Philippine Medical Association earlier said 3 government officials died of complications from stem cell treatments done in the country by non-licensed practitioners." The report could be referring to former Congressmen Pedro Romualdo of Camiguin and Aumentado of Bohol, others.

It is not clear if those government officials died because of the stem cell therapy itself, or their old disease has further advanced to more serious stages and the stem cell therapy was either ineffective or unable to arrest the deterioration of the old disease.

Nonetheless, fake physicians or fake medical practices, fake medicines, they can kill. Or at least they can worsen a patient's condition and hence, make healthcare even more messy and more costly. The DOH and FDA are sometimes clueless that these things are happening more commonly. The DOH for instance issued an order about stem cell treatment only last month, even if these things have been going on for many months or even years.

Government should focus on the rule of law, not on functions that are better left to the private sector and civil society. Drug price monitoring and comparison for instance, is NOT a primary function of the DOH. Even ordinary people themselves can do that -- compare the prices of Mercury vs Watsons vs The Generics vs Rose vs other drugstores. But ordinary people cannot easily detect which medicines are real or fake, which ones can cure and which ones can kill. This function will require laboratory testing, will require lab and medical technologists. That is where the government can ffocus its resources.

Many NGOs, media, politicians and other pressure groups are part of the problem because among their focus is how to demonize the multinational pharma companies. Thus, there are policies like drug price control, EDPMS, IPR and patent tweaking, and so on.  The issue of fake drugs, fake ads in various health products and food supplements, pharmacovigilance and fake medical practitioners often take a back seat.

If existing laws against such fakes are not properly controlled, then more fake stem cell treatment and other illegal medical practices, fake medicines, will happen or proliferate in the country.Bottom of Form

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See also:
Rule of Law 17: Justice Without Discrimination, October 18, 2012
Rule of Law 18: Damaso and Carlos Celdran Conviction, February 04, 2013 
Rule of Law 19: How to Strengthen RoL?, March 25, 2013 
Rule of Law 20: PNP and Rule of Men, April 21, 2013

Drug Innovation 5: The US PCAST Report on Propelling Drug Discovery

* This is my article yesterday in the online magazine,
http://thelobbyist.biz/index.php/perspectives/less-government/item/110-medicines-innovation-and-the-fda
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There was a new report, Report to the President on Propelling Innovation in Drug Discovery, Development and Evaluation made by the President’s Council of Advisors on Science and Technology (PCAST), Office of the President of the United States, dated September 2012. The members of this Council seem to be high profile scientists and academics in some known US universities. The 110 pages report can be downloaded at www.whitehouse.gov/ostp/pcast. 

Among the findings of the report is this chart below: While the number of new molecular entity (NME) and new biological entity (NBE) approvals was declining from their peak in 1996-97, the cost of research and development (R&D) per NME is rising. This chart is found on page 12, then page 35 of the Report.

As a result of this, the Report noted that

heart disease and stroke remain leading causes of mortality, many common cancers are still incurable unless they are caught in the earliest stages, and the vast majority of rare diseases lack effective therapies altogether. Infectious diseases, including those caused by antibiotic-resistant bacteria and viruses with pandemic potential, pose a constant threat of large-scale mortality. And treatments for psychiatric diseases, which impose a tremendous burden on society, are frustratingly limited in their efficacy, as are treatments for neurodegenerative diseases such as Alzheimer’s.

To address this problem, the Report identified two important measures of actions.

1) Scientists need better methodologies and tools for translating basic biological insights into validated therapeutic targets and leads—a gap in the drug discovery and development pipeline that academic scientists often view as “too applied” and pharmaceutical companies often eschew as “too basic” to justify private investment. And

(2) Pharmaceutical developers and regulators need to incorporate new efficiencies into clinical trials of candidate medicines—complex and costly human studies that today constitute fully 40 percent of the biopharmaceutical industry’s R&D budget.

Medicines innovation and invention is not done in the Philippines and many other poor countries due to the high costs, high risks, and high technical regulatory approvals required. For instance, Figure 1 (b) on page 35 showed that by 2010, one academic paper estimated that the cost to innovator pharma companies for each NME is between $884 million to $1.80 billion. Just for one drug alone, and there is no assurance that it will become a blockbuster, high profit drug.

We only have policy making bodies that involve the Department of Health, its attached agencies like the Food and Drugs Administration (FDA), industry players like the multinationals and local generic pharma companies, drugstores and hospitals, health professional and civil society organizations. Like the DOH Advisory Council for Healthcare, of which this writer is one of the members.

One problem with government regulatory agencies, the FDAs in particular – in the US, Europe, Philippines, etc. – is that there is too much emphasis or focus on making the newly-invented drugs to be “very safe, very effective” so that the regulatory approval processes have become so tedious, so strict, that diseases evolve faster than the government approval process. So by the time the very few new drugs that were invented to address certain new diseases have been approved by FDAs, the diseases have evolved into something more sinister and more lethal. Not for big number of people initially but for a few patients only, but has the potential to explode into a highly contagious and infectious disease someday.

If this hypothesis is plausible, then one remedy is for government FDAs to step back and relax a bit their strict drug approval procedures. Bring down the approval process of various clinical trials from 10 or 12 years on average, to only six or eight years. In the process, bring down the average cost of innovation from $0.9 to $1.8 billion per new medicine to possibly only half of it.  Encourage more big generic manufacturers to go into drug innovation business themselves.

In short, turn the focus of accountability away from FDAs and more into the drug innovators and manufacturers . The rule of law and property rights protection says that accountability should stop on whoever initiated something, and the main function of governments is to enforce existing laws, including penalties to violators of regulations governing public health and safety.

So if innovator company A released a drug that turned out to have several adverse reactions, it is incumbent on that company to quickly withraw its drugs worldwide and pay limited penalties only. On the other hand, if innovator company B has released a drug that turned out to be very effective and safe at the same time, then more patients will benefit. A one year delay in marketing a new and effective or revolutionary drug could mean a lot in terms of saving lives.

This should also be a lesson to groups and lobbyists that oppose intellectual property rights (IPR) like patents for new medicines, or at least advocate to keep such IPRs to be as short as possible. It is not easy, it is not a walk in the park, to become a drug innovator. Otherwise, it would be safe to assume or expect that huge global generic manufacturers like Teva in the US, Dr. Reddy in India, and Unilab in the Philippines would be in this business too while retaining their resources in generic drugs production.

The new Philippines FDA Director, Dr. Kenneth Hartigan-Go, is a friend. When he was newly appointed to the post, I suggested to him that the FDA should develop a strong legal and prosecution team, in alliance with the Department of Justice (DOJ) perhaps. It is simply impossible for the FDA to inspect all medicines, all food supplements, all shampoo and skin whiteners, all fat/weight reducers and boobs enhancers, all sauces and juices, all beer and wines, and tell all of us consumers in this country, that they are all safe and have no adverse side effects. Let the manufacturers, wholesalers and distributors stand by their products, to accept full accountability if any adverse results should happen to consumers and/or patients.

And this is where the FDA should come strongly and forcefully. FDA’s message would be: “Do your thing as you swore and submitted to us. If you lied and sell unhealthy products, woe unto you, you will regret that you planned or thought of such thing in the first place.”
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See also: 

Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials, March 28, 2012 
Drug Innovation 2: Sustaining Innovation via Competition, April 14, 2012 
Drug Innovation 3: Biopharmaceutical R&D and Innovation, June 01, 2012

Drug Innovation 4: New Anti-Cancer Drugs, June 08, 2012
IPR and Medicines 25: Patents, Diagnostics and Technology Transfer, October 08, 2012

Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials

To distinguish discussions related to intellectual property rights (IPR) like compulsory licensing, I am starting a new thread in this blog just on "Drug Innovation". This is slightly different from the thread on "IPR and Medicines".

My elder brother who died of prostate cancer more than five years ago would have been 57 years old this week had he survived the disease. His diabetes plus emotional sadness when his wife died several months earlier due to colon cancer further aggravated his condition.

My other relatives, wedding godparents, friends, family members of friends, also died of cancer. There are different types of cancer, probably about 200, and all of them are dangerous. Perhaps all of us have cancer cells in our body, but our immune system are just strong enough to kill those cells, or at least keep them at bay and prevent them from expanding and invading other organs of our body. Our immune system is our best physicians, our best medicines, our best disease examiner, all rolled into one. It is very important therefore, that we keep our immune system strong and efficient, by not injecting too many substances that can weaken them -- like cigarettes, alcohol, fatty food and so on. A little of these substances, like when we attend parties, would be fine and our immune system should be able to repair minor damages. It is the excessive use of such substances that can create more damages in our body.

Medicines and vaccines help boost our immune system in killing undesirable cells like cancer. Usually, old medicines are less efficient in doing this job as human understanding of each disease improve through time. Thus drug innovation is a must. Diseases mutate and evolve, so treatment against such diseases must also evolve.

The business of medicine innovation should be depoliticized whenever possible. There are existing rules governing patent, trademark, copyright and other IPRs, all players, innovator and generic manufacturers especially, understand those rules and do their respective business plans and marketing that are compliant with those rules. That is why I question and oppose moves or proposals that governments should issue compulsory licensing (CL) and related political schemes that disrespect private property rights.

What governments should do, is encourage the entry if not proliferation, of more innovator companies. If there  will be 20 or 50 different innovator companies that develop and roll out new medicines (on top of existing, off-patent drugs) per disease, then the patients will greatly benefit. Competition among such innovator companies will bring down prices of such innovator drugs. Then another round of competition will follow once the patent expires as dozens if not hundreds of generic producers come in to produce their own branded drugs for each disease category.

I am posting below three articles by Reiner Gloor in BusinessWorld on dates indicated. Reiner is the Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), the federation of mostly innovator pharma companies in the country. The three papers are:
1. Beating Cancer,
2. It all begins in innovation, and
3. The value of clinical trials.

The subject of bioequivalence and related tests for safety and efficacy of generic drugs before they will be introduced to the public are discussed. These are useful information that need to be shared to the public.

The most expensive drugs are those that do not work and hence, do not kill a particular disease, no matter how cheap they are. Because an ailing patient would have more complications as the disease inside his.her body is not treated and allowed to expand and inflict more damage in other internal organs of the patient.
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(1) http://www.bworldonline.com/weekender/content.php?id=46080

Posted on 06:05 PM, February 02, 2012

Medicine Cabinet -- By Reiner W. Gloor

Beating cancer

Major non-communicable diseases were among the important health issues that gained the attention of world leaders in 2010. In a United Nations summit, political leaders agreed to a plan of action that sought to address alarming trends involving four major non-communicable diseases (NCD) that have developed to become the world’s biggest killers.

The four major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have altogether prematurely claimed the lives of 38 million people, representing about 63% of the total global deaths in 2008. Studies indicate that the major NCDs are affecting the developing world and lower-income populations hardest.

This is particularly true for cancer, which accounted for about 7.6 million global deaths in 2008. By 2030, cancer deaths are also expected to soar to 11 million worldwide. The World Health Organization (WHO) also disclosed that about 70% of all cancer deaths occur in low- and middle-income countries.

Cancer can affect any part of the body. A defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. This process is referred to as metastasis which is the major cause of death from cancer, the WHO said.

Locally, the Department of Health recently led the observance of the National Cancer Awareness Week in a campaign to boost public consciousness on the disease. Such an awareness drive is important specifically for the Philippine Society of Medical Oncology (PSMO), which considers information as a keystone to preventing and treating cancer.

The need to raise awareness on cancer has become more evident with the GLOBOCAN Project report, which estimated that there had been more than 51,000 cancer deaths in the Philippines in 2010.

The GLOBOCAN Project, which provides global incidence of, mortality and prevalence from major types of cancer, reported that leading new cancer deaths among Filipinos in 2010 include those involving the lung, liver, breast, colon/rectum, leukemia stomach, cervix uteri, brain, prostate and pharynx.

Among Filipino men, lung and liver cancer comprise 43% of all new cancer deaths. These top two killer cancers affected more than 12,000 Filipino men.

On the other hand, breast cancer was the number one cause of new cancer deaths among Filipino women also in 2010. It is estimated that more than 4,000 Filipino women died of breast cancer or 18% of all total deaths during the same year. Around 2,197 women and 1,984 others succumbed to lung and cervical cancers, respectively.

Breast cancer also topped the list of new cancer cases in 2010 followed by lung, liver, colon/rectum, cervix, leukemia, stomach, prostate, brain and ovarian cancer. The top 10 leading sites comprise 68% of all new cases.

Despite the threats posed by cancer, the disease can be reduced and controlled by implementing strategies for prevention, early detection and care for patients with cancer. These include modifying key behavioral and dietary risk factors as well as early detection and screening tests which are important in the diagnosis and treatment before cancer becomes advanced. Vaccination against human papilloma virus (HPV) and hepatitis B virus also help in cancer prevention.

PSMO President Dr. Felycette Gay Martinez-Lapus explained that the fight against cancer requires a collaborative effort among the physician or physicians, the patient, the patient’s family and friends.

She added that treating cancer is a delicate balancing process. The general aim is to reduce tumor growth while ensuring that any potential side effects do not compromise the patient’s quality of life to the extent that the treatment does more harm than good.

Dr. Martinez-Lapus acknowledged that in recent years, there has been a surge of innovative drugs which has forever changed the landscape of cancer treatment.

She said that as opposed to about 40 years ago, life expectancy have increased with new medicines that target the cancer cells directly. Today, targeted therapy is more precise in that it is formulated to act against a specific type of cancer unlike previous treatments.

At the moment, researchers are working on more than 800 innovative medicines that are either undergoing clinical trials or regulatory review. Due to these developments, cancer can now be better managed and even beaten.

Lifestyle Diseases 12: On Fat Filipinos

A cardiologist friend, Dr. Tony Leachon, former medical director of Pfizer Philippines and now a P1 a year consultant to the DOH on non-communicable diseases (NCDs), sent me three of his recent papers on NCDs. He gave me permission to post these in my blog. This is the first and shorter paper. Thanks Tony.

Photos below, I got them from the web, Fierce Fat Filipina Diva, and Fat People of Color. Meaning these are publicly available, voluntarily posted by their authors, I did not steal these shots. Photos added to illustrate the issue that Tony is discussing.
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Fat Filipinos not Funny at all : Young and Poor Affected

Anthony C.Leachon, MD
Philippine College of Physicians

In the Philippines, studies on obesity among children and in adults show that the findings reveal a sad and disturbing pattern. The prevalence rate of obesity has been increasing through the years. The Philippine National Health Evaluation and Survey (2004) has placed the prevalence rate of obesity among Filipino children at 3.2%. This has increased to 4.9% in 2003. Opina (2005) claimed that the gradual increase in the incidence of obesity was likewise noted by the National Nutrition Council of the Philippines survey in 2003. Overweight children aged 0-5 years rose from 0.4% to 1.4%. The prevalence rate of overweight children aged 6-10 years was almost negligible in 1998 but had a significant increase to 1.3% in 2003. Mayuga (2005) however said that the results of a survey conducted by the Food and Nutrition Research Institute (FNRI) of the Department of Science and Technology are more alarming. It was revealed that in 1989, the prevalence rate of obesity among Filipino children was at 5.7%. In 1993 it increased to 8% and in 1998 to 8.8%.

In the schools, malls, and in the clinics, we are seeing more and more obese patients than the last few years through determination of high body mass index (BMI) and high waist to hip ratio. Coupled with this glaring finding is the raised blood sugar and abnormal serum lipid values. This trend is evidently seen in Southeast Asian countries due to globalization and urbanization. If we will not act urgently about this phenomenon through strong government policy recommendations , the Noncommunicable diseases will further hurt the disadvantaged sector specifically the young and poor segment of the population.

NCDs are not exclusive to the affluent elderly patients now but they are seen across all social classes and more dominantly in the young and poor population. This results from unhealthy dietary patterns such as high calorie intake from total fats ( indigenous oils and coconut oil ) , high consumption of sugars and sweetened beverages and low consumption of the more expensive fruits and vegetables. In 1977, Prof Gerald Reaven of Stanford University theorized that obesity was the trigger risk factor in the development of a medical condition known as Syndrome X composed of the ff : obesity, hypertension , diabetes mellitus , hypertriglyceridemia and low HDL. It has undergone massive research work and has evolved into the so- called Metabolic Syndrome leading into NCDs , killing millions every year.

According to Prof Antonio Dans et al , Lancet Article Feb 2011 , abdominal obesity might be more important in people of Southeast Asian countries than from the rest of the world. In the INTERHEART study, waist to hip ratio was a better predictor of coronary artery disease than was BMI. This finding was especially true in Southeast Asian people , in whom a high waist to hip ratio increased in the likelihood of. CAD almost four times compared with a two fold rise in the world population.

Though the prevalence of obesity is increasing in the Asian region, there is paradoxical persistence of under nutrition. This double burden of malnutrition ( undernutrition and over nutrition ) presents a great and difficult public health challenge for a poor country like the Philippines because catch up weight gain after perinatal and postnatal restriction has been postulated to increase risk of diabetes and cardiovascular complications (Stein , 2005).

Recently, Internet addiction , in which the individuals spend an excessive amount of the time online , is recognized by some experts as an evolving medical condition . In the era of the internet, Twitter, and Facebook , obesity will continue to rise due to the lack of physical activity with increase of unhealthy eating patterns - high intake of French fries , burgers, pizza, sweetened beverages , junk foods, and low intake of expensive fruits and vegetables. On another concern , smoking with obesity is a deadly combination - tobacco use among children aged 13-15 years was very common in the Philippines (28 % in boys and 17 % in girls ). (WHO,2009).

One disturbing fact now based on the preponderance of data is the finding that deaths from NCDs in the region are highest in countries that are economically poor. If this inequality or inequity is to be corrected , healthcare delivery has to be structured in a manner that maximizes use of meager resources and strikes a careful balance between speedy public health interventions and medical services. Public and preventive health programs have a unique advantage in that they do not involve massive investments in costly equipment and drugs.

Here are some pioneering recommendations that we need to do differently given our limited resources and the " silent " NCD epidemic that the young and the poor are facing :

1. Transformative education of teachers and all students from the primary and secondary education to the collegiate levels on preventive health education focused on healthy diet options and increase in physical activity with tobacco cessation as top priorities.

2.Local Government Unit heads will have to pass ordinances quickly to curb tobacco use , issue dietary guidelines and food labels , and build infrastructures like provision of pedestrian pathways so people can do physical activities.

3.Workplaces in private and public organizations should build a healthy environment eg smoke free policies,healthy diet options , and facilities for physical activity.

4. The Food Drug Administration with the help of technical experts from the private sector has to regulate the nutritional industry through implementation of Food Label and calorie counter to restrict the use of high calorie foods ,trans fatty acids , sugars, and salts.

5. Civil society , including coalitions of affected individuals and their families , medical organizations, and the media champions should play a major part in holding our leaders accountable for delivering on their commitments on Noncommunicable Diseases.

The time is now to act to protect the young and the poor affected massively by NCDs.
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See also:
Lifestyle Diseases 1: Obesity, February 04, 2011
Lifestyle Diseases 2: Killer diseases in the Philippines, March 16, 2011
Lifestyle Diseases 3: Causes of Mortality in the Philippines, August 10, 2011
Lifestyle Diseases 4: The UN on NCDs, September 24, 2011
Lifestyle Diseases 5: NCDs Global Picture, September 30, 2011