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..

Counterfeit Drugs 7: WHO, InterPol and IFPMA on SFFC

The spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines or simply counterfeit medicines is a big public health problem. Patients who take such fake and/or substandard drugs will not experience improvement from their illness unless their immune system is strong enough. At worse, their condition might even worsen as the disease can mutate and evolve into something more complicated, and can even result to death.

While the more commonly faked medicines are those patented or newly-introduced ones and hence, are priced high, even cheaper but popular generic drugs are also counterfeited. The Department of Health (DOH) and the Food and Drug Administration (FDA) are also raising public awareness of this problem, like this DOH poster.

At the World Health Organization (WHO) website, this basic information is posted.

http://www.who.int/mediacentre/factsheets/fs275/en/

Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines

Fact sheet N°275
May 2012

---

Key facts

• Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source.
• Use of SFFC medicines can result in treatment failure or even death.
• Public confidence in health systems may be eroded following use and/or detection of SFFC medicines.
• Both branded and generic products are subject to counterfeiting.
• All kinds of medicines have been counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines.
• SFFC medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.

Recently, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), based in Geneva like the WHO, produced a short video clip about the danger of SFFC medicines, Watch Out for False Friends.

Some of the points mentioned by the WHO above were reiterated there. It also highlighted that some 124 countries are impacted/affected by these fakes, and 532 products have been counterfeited. The longer, 3:30 minutes version, is found here.

These fakes that are dangerous to public health are being exposed by certain civil society organizations including the federation or association of pharma companies themselves, both innovator and generic. And there is a big role for the government here, when civil society effort are not enough and a bigger, wider network of government agencies, local and national, armed (the police) and non-armed, are needed. After all, the main function of government is to promulgate the rule of law, including the law against stealing the intellectual property of certain companies like trademark, patent and copyright.

The former Executive Director of PHAP, Reiner Gloor, wrote a paper about this subject a few months ago. He discussed the role of the Interpol, in coordination with country governments, drug manufacturers and civil society organizations, in battling this global crime. For instance,

In 2012, an Interpol-supported initiative spanning 100 countries aimed at disrupting the organized crime networks behind the illicit online sale of medicines, resulted in some 80 arrests and the seizure of 3.75 million units of counterfeit medicines worth $10.5 million.

Below is the article.
-------------

http://www.bworldonline.com/content.php?section=Weekender&title=Interpol-in-fight-vs-fake-medicines&id=67608

Interpol in fight vs fake medicines

Medicine Cabinet -- Reiner W. Gloor

Posted on March 21, 2013 07:22:41 PM

FAKE MEDICINES are found everywhere in the world. Emerging economies like the Philippines, as well as highly developed countries with strong regulatory systems, have fallen victims to pharmaceutical counterfeiting.

In the Philippines, close coordination between the government and the pharmaceutical industry has resulted in the monitoring and seizure of counterfeit medicines in Metro Manila and some provinces. A multi-stakeholders alliance advocating patient safety called the Safe Medicines Network has also been established to help the government in the campaign against fake medicines.

Drug Innovation 8: Treating Men's Cancer

My elder brother died of prostate C a few years ago, then my mother's first cousin in Cebu. Nationwide, prostate C I think is among the killer diseases for men. My HMO or private health insurance told me once to undergo a test of prostate C as it might be hereditary in our family but I have done it yet. 

Today, there is a news report from interaksyon.com on men's cancer, that by 2027, the Cancer Research UK foresees that one-half of our gender worldwide will have one form of cancer developing in our body. Not a scary thought for me actually because I will be in the mid 60s by that time. But then any cancer cell can multiply anytime in one's body as one ages and as one's immune system gets weaker.

Here's portion of that news report:

LONDON - A man's lifetime risk of developing cancer is set to reach one in two by 2027, according to new figures released by the Cancer Research UK on Wednesday.

This prediction means that within 15 years 50 men out of every 100 are likely to be diagnosed with cancer at some point in their lifetime as opposed to 44 out of every 100 in 2010.

The research body predicted that women's lifetime cancer risk is also increasing and is predicted to rise from 40 to 44 out of every 100 women by 2027.

But it is still optimistic about cancer surviving thanks to better techniques.

"Cancer survival has doubled in the last 40 years thanks to research developing better techniques to detect the disease and improved treatments to increase survival," it said.

"So while the risk of being diagnosed with cancer is rising, the overall chance of surviving it is improving."

It held that age is the biggest risk factor for cancer and the increase in risk is largely due to more people living longer. As our lifespan increases more people will reach an age when they are more likely to be diagnosed with cancer....

Thanks to modern medicine and the life sciences. Human understanding of various diseases keeps improving. Understanding of a disease, how it starts and how it expands, is a prerequisite to developing a treatment, both in lifestyle change and in medication.

In an article this year in BusinessWorld, Medicines in Development for Cancer, Reiner Gloor of PHAP wrote,

Meanwhile, more than 30% of cancer could be prevented through healthy lifestyle, which includes non-tobacco use, a healthy diet, being physically active and moderate use of alcohol. Furthermore, the chances of beating cancer become higher each day with early detection, vaccination and a steady stream of innovative medicines.

The solid commitment to patients and the advancement of science are at the core of the sustained progress in the fight against cancer. Biopharmaceutical researchers are now developing 981 medicines for all cancer types. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways, announced the Pharmaceutical Research Manufacturers of America (PhRMA).

In its 2012 Report on Medicines in Development for Cancer, PhRMA revealed that several cutting-edge approaches are being employed in search for better treatments for cancer.

The report said that medicines in the pipeline include a drug that interferes with the metabolism of cancer cells by depriving them of the energy provided by glucose. Also in development is a medicine for acute myeloid leukemia (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers. The list likewise includes a therapy that uses nanotechnology to target the delivery of medicines to cancer cells, potentially overcoming some limitations of existing treatments, said the report.

In a bid to address major types of cancer, the report said that there are 121 medicines in development for lung, lymphoma (117), breast (111), colorectal (66), ovarian (63), and stomach (23) cancers among others. In addition, there are 94 medicines and vaccines in the pipeline for prostate cancer. Meanwhile, "orphan drugs" are being developed for rare cancer types that affect less than 200,000 people.

Researchers are also working on treatments for cancer types that affect children. There are medicines in development for brain cancer affecting the young for neuroblastoma, glioma, and glioblastoma.

Many of these candidate drugs have entered clinical trial, or the phase in research and development (R&D) that perform human testing involving up to 5,000 individuals to establish the safety and efficacy of the medicines.

Meanwhile, some medicines in development for leukemia have been granted fast track status or are considered orphan drugs.

Healthy lifestyle like avoiding excessive use of alcohol, tobacco, fatty food and drinks, having a more active rather than sedentary life, is still the best and cheapest defence in preventive healthcare. But should cancer cells or other diseases come in, the use of modern medicines should be tapped whenever possible. 

It is important that public policies and government regulations that tend to inhibit or discourage more medicine innovation, more innovative healthcare schemes under a competitive environment, should be avoided. There is money in healthcare, the same way that there is money in education and housing, in food manufacturing, hotels and restaurants, IT and telecomms, and there is even huge money in politics and excessive government spending. Different players in the pharmaceutical, biotechnology, molecular biology and other life sciences will come in when their risk-taking and health innovation will be properly rewarded, not demonized by politics and heavy government regulations like IPR busting and price control.

CSOs and State 16: The Integrity Initiative

Government is force and coercion. It is an institution created by men and women mainly to protect themselves, their families and friends, their properties, from bullies among the population. It was a good "social contract" where people surrender a portion of their individual freedom to the government, like the "freedom to revenge" and physically attack those who committed physical aggression against them and their properties. Government and its courts, justice and police system is supposed to do that job, to penalize those who disrespect other people's right to peaceful living.

But governments since then have been expanding and getting larger to monster institutions. Rule of law was supplanted by rule of men, and some bullies, thieves and other criminals have captured government power so they can become bigger bullies protected by the government itself and its armed forces. Corruption and plunder is among the byproducts of this situation. Another is large-scale human rights violations, imprisonment if not murder of those who protest dictatorial and despotic governments.

In order to minimize or avoid this situation, government itself created certain offices and mechanisms for self-policing and self-regulation. Thus, the separation of power among the Executive, Legislative and Judiciary branches of government, fiscal and oversight function of opposition political parties, and creation of anti-corruption Commissions, Bureaus or Task Forces within the government. But these offices did not do their function in many countries like the Philippines and thus, corruption has become the norm rather than the exception in many countries and governments. 

Non-government mechanisms and initiatives have sprang up recently in many countries like the Philippines, to help fight government corruption. The approach is different than the usual anti-corruption campaigns. Instead of pressuring government to limit corruption from within, the move is to pressure private enterprises and individuals to stop bribery with government offices and even to report corrupt and extortion practices by certain government officials.

This is the thrust of a new group called the Integrity Initiative (II). I have attended a talk by II Chairman, Ramon del Rosario of the Phinma Group of Companies last month. It was held at the Asian Institute of Management (AIM) in Makati and was mainly sponsored by the Pharmaceutical and Healthcare Association of the Philippines (PHAP) and its partner companies, NGOs and government offices like the DOH.. I liked his talk, short (15 minutes or less), extemporaneous and direct. He said that from an initial 100 company-signatories in 2010, II has grown to more than 1,500 signatory companies. They are now piloting two procedures. One is an Integrity Assessment where companies self-declare certain practices to avoid or minimize corruption with government, and two, an Integrity Validation to be done by a third party and check if those self declaration by a signatory company are correct or not.

During the open forum, I spoke and praised this initiative as truly civil society. It's a unilateral action by the private enterprises and groups themselves to start cleaning up their own ranks first, then demand that government should clean its ranks too. This will be a good branding for company-signatories and have obeyed the processes of II. Thus, II-affiliated companies can "brag" or openly declare that they are doing their businesses in transparent manner and comply with certain government regulations. This can be considered as a trademark by which other companies (suppliers and buyers) and ordinary consumers can hold on and expect that what those companies say are indeed true. A pressure from the outside by a united group of companies from different sectors or fields of business can exert substantial change in government.

I also suggested that while there are industry associations in each sector or industry, some of those associations do not have their own code of ethics and self-regulation mechanisms to avoid unethical marketing and advertising of their products and services and hence, cheat on their consumers. So II can possibly create committees to represent the different sectors and industries that can exert if not impose a code of ethics for member companies in each committee. 

I cited a story of an anesthesiologist friend who complained that they caught one local pharma who sold a counterfeit or substandard anesthesia to one hospital. An anesthesia, if in good standard and effective, is supposed to take effect within minutes to a patient. So for a patient to undergo surgery, he is supposed to feel numbed and be asleep within minutes before the knife will slice his/her tummy or other body parts. But the patient was wide awake, did not get numbed, and it is impossible to do the surgery otherwise the patient will be shouting in deep pain. So the surgeons and anesthesiologists have to scamper for a new set of anesthesia before the surgery can proceed. Surgery done. After that, they reported the incident to the FDA through a very confidential letter, and the pharma company later knew of such letter complaint, meaning they have a "mole" within the FDA and threatened to sue the complaining physicians. 

There were other comments from the audience like those from Leonie Ocampo of the Philippine Pharmacists Association (PPhA). Later, Doc Virgie Ala, the director of DOH-NCPAM, came to represent DOH Assistant Secretary Madz Valera who was supposed to give a talk too in that event, but was not able to come due to a sudden Senate Committee meeting that she has to attend. Doc Virgie expressed support for such civil society initiative like the II, as it would be easier for government offices to reduce corruption if there is such initiative from the private sector.

Civil society organizations (CSOs) and State, not just market and state, is a good initiative to limit government power and coercion. CSOs should be independent of government whenever possible, and not just extension of government like what many NGOs, media and academic people are doing. CSOs should be independent of government funding too, in order to ensure such organizational and philosophical independent from the state.

Meanwhile, PHAP Executive Director Reiner Gloor wrote about that event, I just saw it recently, paper elow. Photos here, he's rightmost. Doc Virgie Ala is to my left. Cecile Sison and former Gov. Obet Pagdanganan of MeTA Philippines, Leonie Ocampo to my right. Lower photos, Mon del Rosario of II and Phinma, and Doc Virgie Ala of DOH-NCPAM.

http://www.bworldonline.com/weekender/content.php?id=62191

The Integrity Pledge

Posted on 05:40 PM, November 29, 2012

Medicine Cabinet -- Reiner W. Gloor

IN 2003, world leaders adopted the United Nations Convention Against Corruption and designated Dec. 9 of each year as International Anti-Corruption Day in a bid to promote a culture that values ethical behavior.

Believing that corruption undermines social progress and results in inequality, the Aquino Administration adopted a platform of government that embraces integrity in public leadership. Early this month, President Benigno S. C. Aquino III. issued Proclamation 506 declaring Dec. 9 as National Anti-Corruption Day. In the proclamation he signed, the President said that corruption undermines the institutions and values of democracy and ethical values as well as jeopardizes sustainable development and the rule of law.

The drive to promote integrity has also been undertaken by the private sector recognizing that the government cannot do it alone. In response to the government’s campaign on good governance, the Makati Business Club (MBC), together with several other organizations, launched the Integrity Initiative (II), a multi-sectoral campaign that seeks to ultimately eradicate the corruption that has worsened poverty and stunted “the development of a competitive business environment that operates on a level playing field.”

Drug Innovation 7: IFPMA, Superbugs and Tropical Diseases

People's lifestyle and communities evolve and continuously change. Their expectations, patience or impatience for more modern lifestyle, including more modern treatment in case they get sick, also evolve and changes. That is how modern medical science, pharmaceutical R&D, diagnostic tests and other aspects of the healthcare industry evolve.

I am reposting below three nice articles by the Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), Mr. Reiner Gloor. These are about the role of drug innovation and how to better encourage it, not demonize it. These appeared in his weekly column in BusinessWorld.

Protecting intellectual property rights (IPR) like drug patents is an important policy measure by governments to encourage innovation. Policy reversals like promoting compulsory licensing (CL) and other variants of IPR confiscation can only discourage innovation. After spending 10 to 14 years in various clinical trials and drugs R&D, and some $1 B or more per candidate drug molecule, it is not wise for governments to simply coerce the innovator companies to give away those efforts to other companies which did not spend equal amount of time and money to develop more revolutionary and more disease-killer medicines.

I have argued it over and over in this blog and other papers, that the main function of government is to promulgate the rule of law, protect private property rights, and the citizens' liberty, freedom of expression and freedom from aggression by bullies. Protecting IPR is consistent with this government role.

The three papers are entitled "Impact of innovation", "Protecting innovation", and "Encouraging innovation". Enjoy reading.

(1) Impact of innovation

Posted on 05:03 PM, November 08, 2012

Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=61108

THERE was a time when infectious diseases such as pneumonia, typhoid fever and tuberculosis ravaged people around the world with no medicines available to treat or prevent them.

Alexander Fleming’s discovery of penicillin and subsequent research yielded new antibiotics that continue to protect the people from simple to complex infections. Since the 1920s, scientists also had their eyes on prevention, management and even cure for non-communicable diseases. Now, thousands of medicines have been produced to treat or prevent diseases, thanks to pharmaceutical innovation.

During the biennial conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva last week, the global research-based medicines industry called for a shared commitment to promote global health through the promotion of further innovation.

These medical innovations, along with other health interventions, have, after all, helped in beating polio on a global scale, and prevented measles, mumps, rubella and other ailments.

IFPMA President Dr. John Lechleiter said that in the past decade alone, vaccines for measles, polio, and diphtheria-tentanus-pertusis have saved the lives of an estimated 21.2 million children under the age of five each year.

He added that between 2000 and 2006, immunization campaigns reduced the number of deaths caused by measles by 68% worldwide and 91% in Africa. Furthermore, immunizations provided to nearly 300 million children in 72 developing countries have saved over five million lives. Reports also showed that global infant mortality fell from 77 deaths per 1,000 births to 62 or a reduction of 20% between 2000 and 2009.

Innovations in medicine have also helped increase cancer survival rates, and dramatically reduce deaths due to HIV/AIDS.

Biopharmaceutical research is likewise being focused on non-communicable diseases such as cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have grown to become the world’s biggest killers.

The biopharmaceutical sector has similarly invested heavily on understanding so-called rare diseases or those which affect fewer than 200,000 people. A deeper look at an individual’s genetic make-up is putting personalized medicine in the forefront of today’s innovation so that detection, treatment and prevention of the disease will be more tailored to the needs of each patient (For more information on personalized medicine, go to www.innovation.org.)

People are also living longer due to medical innovations. In illustrating this, a child born in 1955 had an average life expectancy at birth of only 48 years. In 2000, a child could expect to live 66 years. Life expectancy will increase to 73 years in 2025, it is said. Dr. Lechleiter commented that developing countries are seeing the most rapid gains.

Professor Frank Lichtenberg of Columbia University disclosed “new medicines accounted for 40% of the increase in life expectancy during the 1980s and 1990s in 52 developed and developing countries.”

Apart from the impact to life and health, biopharmaceutical innovations also resulted in economic gains by way of years of productive work, economic value added, consumer spending, and taxes paid.

No less than the World Health Organization (WHO) said that a nation needs a healthy population to achieve economic development. In fact, the 2001 report by the WHO Commission on Macroeconomics and Health stated that “health is a creator and pre-requisite of development.” It emphasized that increasing the coverage of health services and a small number of critical interventions to include the world’s poor could “save millions of lives, reduce poverty, spur economic development, and promote global security.”

The IFPMA Assembly also pointed out that there is strong evidence that innovative medicines are the most cost-effective part of health care. In another study, Mr. Lichtenberg found that for every $1 spent on new medicines for cardiovascular diseases in Organization for Economic Cooperation and Development (OECD) countries, close to $4 were saved in hospitalization and other healthcare costs.

More than economic gains are the social impact of medical innovations on patients who may be our children, siblings, parents and friends.

These days, a diagnosis of a disease does not necessarily mean an end to ties with families and friends.

These gains and the processes that these innovations go through must not be taken for granted. As Mr. Lechleiter said, we must build upon and not rest upon the contributions of the past. For despite our tremendous progress, much more remains to be done.

Socialized Healthcare 9: Grassroots Consultation, Insurance for Catastrophic Diseases

Healthcare for the poor and how public and private resources, especially by the various healthcare providers, will be allocated to help the really needy and not just those pretending to be poor. And should government embark on more regulations and restrictions just to expand healthcare services for the poor.

These and related issues are tricky questions for public policy in healthcare provision. Posting below three articles related to universal healthcare (UHC) by the Executive Director of PHAP, Mr. Reiner Gloor, that can help shed more light and answers to these tricky questions and issues. The three papers posted in BusinessWorld in his weekly column are:

1. Making health by the people, for the people, 13 September 2012
2. Innovative medicine access collaborations, 20 September 2012
3. Protecting people's health, 27 September 2012

The first paper is about some insights after consultations at the grassroots level, where some poor rural folks expect the government health facilities to have more courteous and compassionate staff, more than having modern health facilities.

The second paper  talks about huge price discount by innovator companies to patients of catastrophic diseases like breast cancer, prostate cancer, renal failure and leukemia under the PhilHealth "Case type Z benefit package". Another example of public-private partnership (PPP) with zero government coercion like the drug price control policy via Executive Order (EO).

And the third article is on the university student debates under the DOH Secretary's Cup, where protagonists will debate for or against more government regulations especially in (a) health professionals' fees, (b) advertisement of health products, and (c) distribution of health facilities, technology and services across cities and provinces in the country.

Good readings to start the week. Enjoy.

(1) Making health by the people, for the people

Posted on 05:18 PM, September 13, 2012

Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=58404 

SAN ENRIQUE in Negros Occidental is a 5^th class municipality with a population of more than 23,000 people. It is about 40 kilometers from Bacolod, or about an hour’s ride by public transportation.

Last week, I had the opportunity to visit this municipality -- consisting of 10 mostly coastal barangays -- as part of a partnership with the National Disaster Risk Reduction Management Council where we endeavor to prepare the people of the Western Visayas for calamities.

Apart from the information drive, the partnership sets in motion activities such as deworming, Oplan Timbang, immunization, medical and dental missions, backyard gardening and preparation of low-cost yet nutritious food and menu planning.

Hundreds of people, including the elderly, handicapped, mothers and children, came to the medical mission. Their overwhelming presence gave assurances that we must be on the right track. At the same time, the eagerness of the people to have themselves checked by health professionals in a covered basketball court is evidence that there remain healthcare gaps to be filled.

Also recently, two townhall meetings were held in Cabanatuan City in Nueva Ecija and Malolos, Bulacan with the objective of gaining insights and perspectives from the grassroots concerning key health issues. These were part of the Secretary’s Cup of which I have written.

Two films on health were shown to jumpstart the discussions. The first was about how a poor family copes with the illness of a family member while the second was an excerpt of Sicko, a documentary that probes healthcare in developed countries such as US, Canada and United Kingdom among others.

The discussions and reactions were insightful. However, three points struck me the most.

First, the participants were asked what they think is the most important attribute of a good health facility. I was expecting that a majority would say modern infrastructure or even free medicine. I was surprised to learn that most of them responded that a good health facility is where there are “kind, respectful and compassionate health staff.”

Counterfeit Drugs 6: Online Drugs, US FDA and G8 on Fighting Fake Drugs

Counterfeit drugs are dangerous. A patient taking it may develop new diseases as the original illness is not cured and may have evolved into something more serious inside the patient's body.

Here are four recent articles in BusinessWorld by Reiner Gloor on the subject. Reiner comes from the federation of mostly innovator and multinational pharma companies, PHAP. So he knows this subject through and through. The four papers are:

1. Medicines online, June 15, 2012
2. What's in a fake drug, June 01, 2012
3. G8 commits to fight global counterfeiting, May 25, 2012
4. Keeping safe from counterfeit drugs, February 23, 2012

(1) Medicines online 

June 15, 2012

Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=53465

In the Philippines, a global research marketing group disclosed that one in three Filipinos have access to the internet. The 2011 Nielsen report further said that five in 10 survey respondents have high-speed internet connections at home while others frequent cafés or use their mobile phones to surf the Web.

The rapid growth of internet penetration in the country is expected to result in huge benefits. However, a recent global meeting of world leaders called for the need to put up barriers to threats that could adversely affect a user’s health, among others. The so-called Camp David Declaration of the Group of Eight Nations recently pledged to protect public health and consumer safety by committing to exchange information on rogue internet pharmacy sites that sell counterfeit medical products. The Declaration came ahead of World Anit-Counterfeiting Day on June 7 that also focused on pharmaceutical counterfeiting.

On May 29, the US Food and Drug Administration (FDA) warned consumers and healthcare professionals about a counterfeit version of a medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. The fake version of the controlled substance is being sold on the internet.

The FDA reported that preliminary lab tests showed that the counterfeit version of the 30 mg tablets contained the wrong active ingredients. The genuine drug contains four active ingredients. The fake medicine was found to have tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain. The physical look of the fake product purchased from the internet is a giveaway. It did not come in its original package, the color and shape of the pils were irregular, and there were no markings on the tablets. There were also misspellings on the package such as “Singel” instead of “Single” and “Aspartrte” instead of “Aspartate.”

Developed countries have established a system of regulating legitimate online pharmacy sites. But even with safeguards, counterfeit medicines continue to be a threat to those who purchase drugs online.

Some copycat medicines sold on the internet fit the World Health Organization (WHO) description of “spurious, falsely labeled, falsified and counterfeit” medicines. Their ingredients are too strong or weak, have dangerous ingredients, are expired, and are not manufactured using safe standards. If taken by a patient these could have dire health consequences.

Furthermore, fake pharmacy sites sell medicines that are not appropriate for one’s condition while other sites place personal credit information at risk.

Drug Innovation 4: New Anti-Cancer Drugs

A good article today in BusinessWorld by Reiner Gloor of PHAP, about several hundred new medicines being developed, many of which are still in the laboratories and undergoing various clinical trials, against various types of cancer.

Good healthcare is mainly about having healthy lifestyle, avoiding high intake of risky substances like tobacco and alcohol products, high fat/high calorie food and drinks, early detection of diseases for early and less costly treatment, and new, more powerful medicines against diseases once the latter have developed inside our body.  The production and sale of generic drugs once the patent on innovator drugs have expired, is also an important part of good healthcare.

I also included his paper last year also from BWorld, about the discovery of Insulin. Below, photos of various cancer cells, from top left, clockwise: (a) breast cancer, (b) brain cancer, (c) prostate cancer, (d) a cancer cell being attacked by the immune system, (e) lung tumor, (f) brain cancer.

Photo sources:
1. http://www.alternative-cancer.net/Cell_photos.htm
2. http://www.environmentalgraffiti.com/featured/images-inside-human-body-images/8292
---------


(1) Medicines in development for cancer

Medicine Cabinet -- Reiner W. Gloor
June 08, 2012

http://www.bworldonline.com/weekender/content.php?id=53071

Some do not want to talk about it while others call it the Big C. Experts refer to it as an emerging epidemic as well as a leading threat to global health and development. Whatever it may be called, cancer is no matter to be taken lightly.

Around the world, fathers, mothers, sons, daughters, and friends have lost loved ones to cancer. Men and women, adult and children, and rich and poor alike, are all vulnerable to the disease that has developed into one of the world’s biggest killers.

Cancer, along with cardiovascular diseases, diabetes, and chronic respiratory diseases altogether prematurely claimed the lives of 38 million people in 2008, affecting the developing world and lower-income populations hardest. In fact, about 70% of cancer deaths occurred in these countries where health systems are characterized by high out-of-pocket spending.

In the same year, the World Health Organization (WHO) said that 7.6 million died of cancer, representing around 13% of deaths worldwide. In the Philippines, the GLOBOCAN Project reported that there had been more than 51,000 cancer deaths in the country in 2010.

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

There are valid and serious reasons why people fear cancer. For one, there are more than 100 types of cancer that could affect just any part of the body. And, as mentioned, it defies gender, age and socio-economic class. If not detected early on, worldwide statistics would attest to its irreversible consequences. The WHO disclosed that deaths from cancer worldwide are projected to continue rising, with an estimated 13.1 million deaths in 2030.

Meanwhile, more than 30% of cancer could be prevented through healthy lifestyle, which includes non-tobacco use, a healthy diet, being physically active and moderate use of alcohol. Furthermore, the chances of beating cancer become higher each day with early detection, vaccination and a steady stream of innovative medicines.

The solid commitment to patients and the advancement of science are at the core of the sustained progress in the fight against cancer. Biopharmaceutical researchers are now developing 981 medicines for all cancer types. Many are high-tech weapons to fight the disease, while some involve innovative research into using existing medicines in new ways, announced the Pharmaceutical Research Manufacturers of America (PhRMA).

In its 2012 Report on Medicines in Development for Cancer, PhRMA revealed that several cutting-edge approaches are being employed in search for better treatments for cancer.

Health Transparency 7: DOH Advisory Council, CHAT

There is a section in RA 9502 or the Cheaper Medicines Law (2008) that allows for the creation of the DOH Advisory Council for Price Regulation. I have written about the Council and the discussions there about the imposition of drug price control (or regulation) since June 2009, see Health Choices and Responsibilities, pages 2-13, then pages 63-76, of the book.

Some photos of the Council meeting sometime in 2009, below.

After about a year, then presiding officer of the Council, former DOH UnderSecretary Alex Padilla, now PhilHealth CEO or COO, moved that the Council be transformed from Price Regulation into "Advisory Council for Healthcare". There was consensus among members of the Council -- representatives from different industry associations (local and multinational pharma, drugstores, hospitals), professional associations (medical, pharmacists, other government agencies, and NGOs -- to support it.  That is because there was general consensus among the members that price control and regulation only distorted an already downward trend in medicine prices due to more competition among more players with more products introduced into the market. And price control did not really achieve its goal of making some essential medicines be more affordable to the poor, for some really poor people, they want the price to be zero, not just 50 percent cheaper of its original price. But the policy was carried out due to politics leading to the May 2010 Presidential elections.

There are four NGOs that are regularly invited in the Advisory Council: (1) Cancer Warriors Foundation (CWF), (2) Cut the Cost, Cut the Pain Network (3CPNet), (3) Ayos na Gamot sa Abot Kayang Presyo (AGAP), and (4) Minimal Government Thinkers.

The first three were active in the deliberations and enactment of RA 9502 while MGT is invited despite its being an "outlier" to help provide wider and broader range of perspectives in many public health discourses. For instance, MGT is perhaps the only NGO and think tank in the Council that explicitly argues for "less government" in Philippine society. MeTA Philippines leadership is also invited from time to time to the Council.

Below, upper photos, another Advisory Council meeting, chaired by former DOH USec Alex Padilla and DTI Assistant Sec. Baua, and one of those slides presented during the meetings. Lower photos, during the public hearing of the Congressional Oversight Committee on RA 9502 at the Senate, May 10, 2012. USec Padilla and ASec Baua were among those who spoke there.

During the Congressional Oversight Committee meeting last month, chaired by Sen. Manny Villar and co-chaired by Cong. Albert Garcia, Cong. Ferjenel Biron looked down on the role of the Advisory Council. Compare the nature of the Council vs. Cong. Biron's perspective.

The Council meets only on occasions where in the judgment of the DOH, there are important health matters to discuss that requires broad discussion and information from multi-sectoral participants. Hence, the Council has  no regular meeting, is not a permanent bureaucracy with its own set of regular bureaucrats. I think all members of the Council are comfortable with it.

Cong. Biron on the other hand wants a more permanent bureaucracy, the Drug Price Regulation Board (DPRB) with its own set of permanent bureaucrats. Based on his actuations and hard-sell eagerness to push it, I think he positions himself to to head that bureaucracy someday should it become a law.
--------

In my discussions with some health NGO leaders, like those belonging to the Coalition for Health Advocacy and Transparency (CHAT), the civil society partner of the Medicines Transparency Alliance (MeTA) Philippines, I always emphasize the importance of coupling right and responsibilities. Former DOH Secretary Alran Bengzon also emphasized this when he gave a talk several months ago, sponsored by AGAP. Rights and responsibilities are twins in the healthcare (or any other social/public policy) issue/s.

Consider this. Even if government will provide free medicines, free hospitalization, free diagnostic tests, free physician consultations ("health is a right" kasi) but if people do not take care of their body and that of their households, do not observe even very basic sanitation, health outcome will remain poor. We do not need the DOH or WHO or PhilHealth or the provincial/city hospitals, to tell people that over-drinking, over-smoking, over-eating, over-sitting, living in dirty places, etc. is bad to one's health. Healthy lifestyle, or preventive healthcare, is a lot more cost efficient, more useful, in attaining good health outcome for the population.

Below, during some of CHAT fora and meetings, sometime in 2009-2010.

Below, upper photos, the Pharmaceutical and Healthcare Association of the Philippines (PHAP), in partnership with CHAT, also organized a social dialogue with civil society organizations (CSOs) on universal health care (UHC). Lower photos, with Dr. Krisana Kraisintu, an NGO leader in Thailand who was among the recipients of the Ramon Magsaysay Award in 2009.

Rights without responsibilities will result in laziness and irresponsibility among the people. I have noticed that  the bulk of public health debates in the past until now, have been focused on curative healthcare -- people are sick, they need cheap medicines, subsidized or free medicines, free hospitalization, etc. -- very seldom on preventive healthcare.

Sometimes CSO leaders appear like politicians. They promise their supporters of this and that social "rights" from the government, and seldom or never tell them they have responsibilities to each right.

There is obligation to each entitlement. If we remove obligations, then we might be building a society of  welfare-dependents and rent-seekers.

I am happy to note that many fellow NGO leaders, at least within CHAT, implictly agree with my above thesis. Why did I say this, well at least they did not debate my above points :-)

In my next paper on "Health Transparency", I want to write about the role of MeTA Philippines. Generally they are doing a good job in making medicines pricing, access and availability, become more transparent. Although I think public awareness of the body and its activities remain low.
-------

See also:
Health Transparency 4: Drug Promotions and Government, September 03, 2010
Health Transparency 5: Forum on Good Governance in Health, March 08, 2012
Health Transparency 6: Physician Protectionism, May 19, 2012


FDA Watch 1: BFAD Strengthening Bill, May 06, 2009
FDA Watch 2: Inspection of cGMP Compliance, January 31, 2011
FDA Watch 3: Resignation of Dr. Suzette Lazo from FDA, May 16, 2012

Socialized Healthcare 5: Alterrnative Views on Universal Healthcare

Rights should always be coupled with responsibilities. Some people agree by saying that "With greater rights and freedom comes greater responsibilities." That is one way of saying it; another way is "With greater (personal) responsibilities comes greater (personal/individual) freedom." As Friedrich Hayek said, "People who are afraid of responsibilities are afraid of freedom itself."

In many discussions on health policy, what is often asserted and formulated is that "health is a right" and hence, "universal healthcare is a right." I have no problem with this formulation if this should also be added, that "health is a responsibility", and I am referring to individual (and parental/guardian, civil society, community) responsibility, not just government responsibility as is commonly understood. Thus, "health is a right, health is a responsibility" is easily intertwined.

Below are three articles in BusinessWorld by one of my friends in the local health sector, Reiner Gloor, Executive Director of PHAP, on universal healthcare. I agree with many -- but not all -- of his arguments here. I can sympathize with greater government health support and subsidy for the poor suffering from infectious or communicable and tropical diseases. But I have little or no sympathy for government subsidy for lifestyle-related diseases like illnesses due to heavy smoking, heavy drinking, heavy eating of fatty or junk foods, heavy sitting or sedentary lifestyle.

Reiner is speaking from a private sector and civil society point of view, not government's. So these papers have a balanced perspective on the issue of universal healthcare.
--------

(1) http://www.bworldonline.com/weekender/content.php?id=50666

April 27, 2012

Medicine Cabinet -- Reiner W. Gloor

Universal health care coverage provides safety net for the poor

EmailShareThis

For many poor people, health has become a difficult economic choice between getting better or poorer.

Often characterized by high out-of-pocket spending, health financing systems in low- and middle-income countries have contributed to the vicious cycle where diseases worsen poverty, while at the same time, poverty results in rising incidence of diseases.

The World Health Report 2010 estimated that about 150 million people globally suffer financial catastrophe when they avail of health services. Similarly, 100 million people are pushed into poverty due to direct out-of-pocket spending.

In the Asia-Pacific region alone, about 80 million people experience financial catastrophe and 50 million others are impoverished due to health payments.

These happen since in low- and middle-income countries, health is paid for privately or mainly from out-of-pocket health care systems. The same is true for the Philippines that reported a private out-of-pocket share of 54.3% while government funding was 26.2% and social insurance, 8.5%.

This was validated by the Social Weather Stations (SWS) survey of Filipinos on Health Services and Financing which revealed that for those who have consulted a doctor when they were sick, seven out of 10 of them paid from their own pockets.

The video documentary, "The Road to Universal Health Coverage", emphasized that when households spend a substantial part of their income on health, the results can be catastrophic.

In fact, the same SWS survey disclosed that almost three out 10 Filipinos deferred visits to doctors even if they were sick because they felt that they cannot afford to pay for health care. Seven out 10 respondents also believed that many families get impoverished when a member gets sick and has to be hospitalized.

In shielding families from financial catastrophe and other disastrous social outcomes of direct out-of-pocket health payments, the video documentary highlighted the pressing need for countries to adopt and implement financing strategies leading to universal health coverage.

Socialized Healthcare 4: On Health for All

One of the recurring and never-ending discussions in public policy is Universal Healthcare or Health for all. I have no question with this, I even support this initiative. What is being discussed and debated upon  is how to attain this, via (a) More government intervention, in pricing, supply and distribution of drugs and related health requirements, or (b) less government interventiom and more competition among various industry players.

Below are three recent articles by the head of PHAP, Mr. Rainer Cooler, on this subject. It is a good perspective from the innovator drugs sector. Enjoy! 

(1) Health for all

Reiner W. Gloor, April 20, 2012

http://www.bworldonline.com/weekender/content.php?id=50268

Against the backdrop of political and economic uncertainties, health inequities between developed and developing countries and within countries have widened to such a degree that people found “politically, socially and economically unacceptable”.

With the growing concern on health disparities, the World Health Assembly (WHA) proposed in 1977 a major social goal for governments to achieve by the year 2000 a level of health that would permit them to lead a socially and economically productive life. Towards this end, the WHA unanimously endorsed a Global Strategy of Health for All in 1981 that ushered in the “Health for All” movement.

This strategy was reinforced at the 51st WHA in 1998, where world leaders signed the World Health Declaration, in which the “Health for All in the 21st Century” policy was adopted to carry forward the vision of HFA as stated in the Alma-Ata Declaration of 1978.

“Health for All” emphasized the attainment of the highest possible level of health by societies as a basic human right, and where health policies and strategies are guided by principles of equity and solidarity.

The World Health Organization (WHO) explained that “Health for All” does not mean the eradication of disease and disability, or that health professionals such as doctors and nurses will care for everyone. HFA means that resources for health are evenly distributed and that essential health care is accessible to everyone.

The goal of HFA is the achievement of full health potential for all. This can be attained through the promotion and protection of people’s health throughout their lives and the reduction in the incidence of major diseases and injuries while alleviating the suffering they cause.

The global strategy of a “Health for All” is equally important in a country where, according to the National Housing Targeting System (NHTS), about 5.2 million families or approximately 26 million of Filipinos live below poverty line. These are the individuals, who by standards of the World Bank, earn merely USD1 a day.

Using the social determinants of health approach, social and economic conditions and their effects on people’s lives determine their risk of illness and the actions taken to prevent them becoming ill or treat illness when it occurs. For instance, evidence shows that the poorest of the poor have the worst health. In general, health turns from bad to worse as the socioeconomic condition of a person goes lower.

The social determinants of health are the conditions in which people are born, grow, live, work and age, as well as the health system. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels, which are themselves influenced by policy choices.Social determinants of health are mostly responsible for health inequities or the unfair and avoidable differences in health status seen within and between countries, the WHO explained.

Health inequities are evident in various health indicators in the country which varies, depending on the social and economic conditions of the household. The National Demographic and Health Survey (NDHS) of 2008 revealed inequities in mortality rates by reason of residence with high poverty incidence.

For example, the under-five mortality rate for the in urban areas is 28 per 1,000 live births compared to 46 in rural areas. Under-five mortality is also highest in Autonomous Region in Muslim Mindanao or ARMM (94 deaths) and Eastern Visayas (64 deaths) and lowest in the National Capital Region (24 deaths).

The NDHS also showed that childhood mortality decreases with mother’s education and household wealth. There are only 17 under-five deaths per 1,000 live births in the wealthiest households compared with 59 deaths per 1,000 live births in the poorest households.

While vaccination coverage is above 70% in all regions, only 31% of children between 12 and 23 months in ARMM received all the recommended vaccinations to include one dose each of BCG, measles and three doses each of DPT and polio.

Furthermore, majority of Filipino women receive at least some antenatal care (ANC) from a skilled provider, most commonly from a midwife (51%) or doctor (39%). With the exception of ARMM, more than 85% of women in all regions received some ANC. However, the NDHS said that only 47% of women in ARMM received ANC.

In addressing health inequities, the Philippines is on its way to implementing universal health care, which is defined by the Universal Health Care Study Group as provision to every Filipino of the highest possible quality of health care that is accessible, efficient, equitably distributed, adequately funded, fairly financed and appropriately used by an informed, empowered public. Universal health care will ensure health as a right, regardless of social determinants -- particularly one’s ability to pay.