CAP: Ban lead in products to combat lead poisoning

CAP President Mr Idris and Research Officer Hatijah Hashim emphasizing toxicity of Lead.

Lead is a cumulative toxicant that affects multiple body systems. It is particularly hazardous to young children, pregnant woman and all those that are exposed to it. Effects of exposure include learning disabilities, increased risk of antisocial behaviour, reduced fertility and increased risk of renal and cardiovascular disease later in life.

The World Health Organization (WHO) has recognized October 22-28 2017 as International Lead Poisoning Prevention Week and its main concern is the role of lead exposure in the development of intellectual disability in children.

The health impacts of lead exposure on young children’s brains are lifelong, irreversible and untreatable, Lead is also introduced into the gastrointestinal tract when children chew on objects such as toys, household furniture or other articles painted with lead paint. Continued use of lead paint is a primary source of childhood lead exposure. Urgent measures need to be taken to reduce critical sources of lead exposure to young children.

In early 2016, CAP tested paints and we found more than 60% of the samples tested contained exceedingly high lead levels. More than one year has passed since then but the Malaysian authorities have not come out with laws on lead in paints.

The World Health Organization (WHO) calls lead paint “a major flashpoint” for children’s potential lead poisoning and says that “since the phase-out of leaded petrol, lead paint is one of the largest sources of exposure to lead in children.” Children are exposed to lead when painted surfaces deteriorate over time and contaminate household dust and soils. Children, ages 0-6, engaging in normal hand-to-mouth behaviors are most at risk of damage to their intelligence and mental development from exposure to lead dust and soil.

Recent studies conducted by the Department of Toxic Substances Control (DTSC) in California found jewellery for adults and children containing dangerously high amounts of lead in one or more component of the item. Some of the items tested were found to be practically made of lead.

In a survey CAP found similar items being freely sold in the market These  items are popular among children as they are brightly coloured and decorated with cartoon characters Priced  from RM 1.00 to RM3.00  it is  affordable to children.

Sindoor is widely used by Hindus in Malaysia. It is a brilliant scarlet powder used during Hindu religious and cultural ceremonies.  Sindoor is often used by women who wear a bindi, or red dot, on their foreheads for cosmetic purposes.  Hindu men and children also wear it for religious purposes Tests conducted in the US found dangerously high level of lead in sindoor. Some manufacturers use lead tetroxide to give it a distinctive red colour.

Of the 118 sindoor samples tested in the study, 95 were from South Asian stores in New Jersey. Another 23 came from stores in Mumbai and New Delhi, in India. Overall, about 80 percent of the samples had at least some lead, and about a third contained levels above the limit set by the U.S. Food and Drug Administration.

The FDA’s limit for lead in cosmetics is 20 micrograms per gram. Nineteen percent of the U.S. samples and 43 percent of the India samples exceeded that limit. Five samples – three from the U.S. and two from India – contained more than 10,000 micrograms.

In view of the dangers of lead CAP calls on the authorities to:

* Ban lead in products,

* Test products that have been found to contain high levels of lead

* Come out with a campaign to create awareness on the dangers of lead.

* Without a ban Malaysia will be a dumping ground for products with high levels of lead that have been rejected by other countries.

As lead has a strong impact on children, immediate action need to be taken to safe guard our future generation.

Press Statement, 25th October 2017

CAP Welcomes Government Move On Hepatitis C Medicine, Calls For It To Be Made Available Within A Few Days Or Weeks

The Consumers Association of Penang congratulates the Government for issuing a license relating to the “rights of government” to obtain generic versions of the Hepatitis C medicine sofosbuvir, as announced by the Minister of Health, Datuk Seri Dr S. Subramaniam in his press statement on 20 September.

This move has raised hopes of the 500,000 Hepatitis C patients in Malaysia and their families that at long last there can be an effective cure made available at affordable cost.

We call on the government to make the medicine available to patients within days or at most a few weeks.

The government measure should result in massive savings of 95-99 per cent.  The present price of a full course of treatment for 12 weeks is about RM300,000.

The Minister said at his press conference on 20 September that the last price negotiated with the company that holds the patent for sofosbuvir was RM50,000.  CAP believes that with the “government use” license” that has been issued, the use of generics can decrease the price to a range of RM500 to RM1,000 per patient per course of treatment.

In other words, the government and the patients can save cost up to 95-99 per cent by obtaining generic versions of the medicine, through the issuing of the government use license.

Malaysia is the first country in the world to issue a government-use license or a compulsory license for sofosbuvir or any medicines in the category known as direct acting anti-virals (DAA) which are effective for treating Hepatitis C. The Malaysian action could inspire other countries to do likewise.

Issuing such a license is fully compatible with the rules of the World Trade Organisation and the Malaysian Patent Act.

We congratulate the Minister of Health and his colleagues in the Health Ministry and other Ministries for this bold move that will benefit many thousands of patients.\We call on the government to take the necessary follow up action to procure the drug sofosbuvir and make it available within a few days or weeks, as so many thousands of lives are at stake.

The Health Ministry should also explore other Hepatitis C drugs that are required for use in combination with sofosbuvir, and take measures to remove restrictions to their sale at affordable prices in Malaysia.

The Health Ministry should also complete its clinical trials undertaken in cooperation with Drugs for Neglected Diseases initiative (DNDi), and continue its collaboration thereafter with the aim of making an appropriate combination drug available in Malaysia at the initial targeted price of RM1,000 per treatment per patient.

Press Statement, 21 Sept 2017

CAP Applauds Government Decision to Issue Government Use License for Hepatitis C Drug, which can save hundreds of thousands of lives

The Consumers Association of Penang welcomes and applauds the Malaysian government’s decision to issue a government use license that will enable the government to import medicines for Hepatitis C treatment at the lowest possible prices and cure the hundredsof thousands of Malaysians infected with Hepatitis C virus (HCV).

According to various reports and reliable sources, this decision was taken by the Cabinet on 4 August 2017.

The government’s action to issue the government use license is perfectly legal under Section 84 of the Malaysian Patents Act to address barriers imposed by patents that lead to prohibitive drug prices, and is in line with the rules of the World Trade Organisation (WTO), specifically its TRIPs Agreement (Trade-related Intellectual Property Rights Agreement).

HCV is a major national and international concern. It is highly infectious and a major cause of mortality, with 400,000 deaths a year worldwide.

In Malaysia, it is estimated that about 2.5% of the adult population (i.e. about 500,000) is infected with Hepatitis C.  Many more are likely to be affected, as most people infected with HCV are unaware of their status until it has progressed to advanced liver disease, liver failure or cancer.

In recognition of its public health importance, the United Nations General Assembly, as part of the 2030 Agenda for Sustainable Development, called for specific action to combat viral hepatitis.

In May 2016, the World Health Assembly adopted the first “Global Health Sector Strategy on Viral Hepatitis, 2016-2021”, which set out a vision of eliminating viral hepatitis as a public health problem by 2030.

Until recently, Hepatitis C treatment was based on therapy with pegylated interferon and ribavirin which required weekly injections of 24 to 48 weeks. The therapy has poor treatment outcomes and life-threatening side-effects.

The availability of oral direct acting antivirals (DAAs) has revolutionized treatment with cure rates exceeding 90% and shorter treatment duration with good safety profiles. In short, Hepatitis C can now be cured with a simplified and relatively safe oral regimen.

However prohibitive prices has hindered access and use of these anti-virals in Malaysia.  Very few Malaysian patients have been able to use the new drugs.

In July 2017, news reports cited Hepatitis C experts at the Universiti Malaya as stating that the cost of full treatment per patient may be up to RM300,000.

The exorbitant prices are due to patent monopolies held by multinational pharmaceutical companies existing over the anti-virals, in particular sofosbuvir, which is the backbone anti-viral for any HCV treatment regimen. The monopoly and unsustainable prices charged has been at the expense of the lives and health of hundreds of thousands of patients and this is simply unacceptable.

Thus, we strongly welcome Malaysian government’s decision to issue a government license that will enable the government to urgently source and secure the supply of Hepatitis C  treatment from generic drug companies.  A government use license, similar to a compulsory license, allows for the sale of generic versions of a patented drug.  Without this license, only the patented version is allowed to be sold.

The Ministry of Health is conducting clinical trials in Malaysia of relevant Hepatitis C drugs in cooperation with the Geneva-based Drugs for Neglected Diseases initiative.  This is part of a project where it is envisaged that the government will be able to obtain a combination of two DAAs from the Egyptian generic drug industry for a targeted price of RM 1,000 per patient.   However, for this project to succeed, the government needs to issue a government use license (similar to a compulsory license), which is why it is so important that a decision has been taken to do so.

According to recent media reports, the originator US company Gilead is now offering to include Malaysia in the list of countries eligible to take part in its licensing scheme that allows for some generic versions of sofosbuvir to be sold locally.

The government’s move to issue a government use license is one reason why the company has after so many years agreed to include Malaysia in the scheme.

However it is imperative that the government sticks to its decision to issue a government use license for sofosbuvir.  This is because there are strict limits to what Malaysia can do or cannot import or produce under the Gilead license, and other factors that restrict the freedom to choose the generic companies that it can work with.

By issuing a government use license, the government will have maximum degree of policy choices to determine the combination drugs, the prices, and the companies and institutions to cooperate with,  and be able to secure the lowest possible prices for Hepatitis C treatment.

Therefore, it is best for Malaysian consumers and patients that the government have both the government use license as well as the license scheme that Gilead will extend to Malaysia.  Both can co-exist, providing Malaysia with maximum policy choice.

In other countries where a compulsory license or government use license is planned or is issued, there are reports of pressures exerted by the companies holding the patent or by the governments of these companies not to issue or not to implement the measures.  CAP sincerely hopes that such pressures will not be placed on Malaysia.  Indeed, Malaysia should be praised worldwide for taking these pro-public health measures.

The Malaysian government measure of issuing a government use license is not only legal national and internationally but in line with the landmark 2001 WTO Ministerial Declaration on TRIPS and Public Health, that urged developing countries “to affirm their rights to use to the full the provisions of the TRIPS agreement to protect public health and in particular provide access to medicines for all.”

A breakthrough long awaited for by millions of Malaysians, especially those with a family member suffering from Hepatitis C, is now within sight.

For this to happen, the government must act swiftly and courageously.

1. We urge the government to immediately implement the issuing of a government use licenseon sofosbuvir and to then take urgent action to import the much needed drugs and act quickly so that they are available in hospitals and clinics in Malaysia.

2. The Health Ministry should also explore other Hepatitis C drugs that are required for use in combination with sofosbuvir, and take measures to remove restrictions to their sale at affordable prices in Malaysia.

3. The Health Ministry should also complete its clinical trials undertaken in cooperation with Drugs for Neglected Diseases initiative (DNDi), and continue its collaboration thereafter with the aim of making an appropriate combination drug available in Malaysia at the initial targeted price of RM1,000 per treatment per patient.

Press Statement, 8 September 2017

WHERE IS OUR MEDICAL EDUCATION HEADING?

The last few months has seen a lot of discourse in the media on the plight of young trainee doctors or housemen as they are called.   We saw a lot of shocking headlines – ‘not cut out to be doctors’, ‘grappling with housemen woes’, ‘housemen buckling under pressure’ – just to name a few. The most shocking revelation was that housemen comprised the highest number of civil servants who were sacked.   According to some media reports 1 out of 5 housemen drop out annually with the total dropouts numbering up to 1000 or more annually

The average cost of studying medicine at a foreign university branch campus in Malaysia is around RM500,000 excluding living expenses.  Just taking this as a benchmark you’re looking at a loss of RM500 million.  This is a colossal waste of resources. After spending years in tuition and training only to drop out just at the threshold of their medical career.

Of course the obvious question that arises is ‘why?’ The rigidity of training during the two year internship period could not have changed much. If anything it was perhaps worse in the last few decades as there was always a shortage of doctors in the government service and hence a heavier workload.  The notion of working through 36 hours is not new.  Most senior doctors have gone through this and while it was tough and grueling – it was seen as part and parcel of the rigorous training that is required for this noble profession of saving lives.

So why is it now that there are not enough places for housemen training, in other words when housemen are in plenty and hence one would assume a lower work load than in the past , are these young people dropping out and not able to cope with the demands of the training?

It has a lot to do with the attitude and aptitude of these students towards medicine as a career.

Why choose medicine as a career when the attitude and aptitude is lacking.  In secondary school itself it can be assessed whether students are cut out for medicine as a career.

Let’s examine some of the reasons for the current trend.

·         Indiscriminate mushrooming of medical schools

There are 34 public and private medical schools in the country churning out thousands of medical graduates every year.  In 2014 over 7000 new medical graduates passed out from these schools.  The number increases every year.   How did so many medical schools appear suddenly? Was a needs assessment done before these schools were allowed to be established?  Considering that the compulsory housemen training can only be done in government institutions surely some assessment should have been done on the number of medical graduates that will be coming out annually and whether the health system had the capacity to absorb them.

·         Lower entry standards

With so many schools and the need to fill up the space the entry requirements would have been lowered over the years.  At one time, entry to medical school was one of the toughest and only the brightest and toughest students made it.  Now it seems to be relatively easier to gain entry to medical school.  The quality of teachers and teaching too would have simultaneously lowered.   It is common knowledge that education is a big business and some medical schools have been set up for financial reasons.

·         Student capability

Perhaps the most important issue is the capability of the students and their aptitude and attitude for medicine as a career.  Despite the course being long and expensive, the demand is there.  Many are lured by the notion of glamour and money that comes with the medical profession. Many others are unfortunately pressured by their parents to study medicine. Some families who want to carry on a family business or practice in medicine go to extreme lengths to enroll their children in medical schools even though they do not meet the academic criteria or have the aptitude.   It would not be far-fetched to say that the genre of students now is of a different quality from a generation or two ago.  The present generation is a much pampered lot with a much lowered tenacity to withstand stress and reprimand. Hence the increasing drop-out rate during the housemen training period.

The solutions

The situation is dire and immediate measures are required to stop the rot from further setting in.  The medical profession deals with human lives and any erosion of standards due to policy failure is a grave misgiving on the part of the government.

CAP calls for an independent panel of experts to be set up to look into the quality standards of medical education in the country.  This panel should comprise not just of medical experts but people from other fields as well such as legal, engineering, nursing etc.  The aim of this panel would be:

·         To conduct an assessment of all medical schools in the country in terms of entry standards, quality of teaching, standards of examinations.  External examiners should be considered.

·         To ensure potential students have the right attitude and aptitude for medicine and are fully aware of the challenges in a medical career.

·         To set standards and ensure these are monitored and adhered to.

Letter to Editor, 9 May 2017

The Need To Conduct More Frequent Clinical Audit And Enforcement Activities In The Private Sector

The recent case involving the death of the son-in-law of the Deputy Prime Minister who had been given anaesthesia by unqualified personnel in a private dental facility raises a big question with regard auditing of private healthcare facilities. This particular case received nation-wide attention because it involved a family member of a VIP. There could easily be many more such unreported cases among the lay public.

The Private Healthcare Facilities and Services Act and Regulations, 2006 was formulated and implemented to provide guidelines for healthcare providers regarding the mandatory and standard requirements in areas of its’ organisation and management, policy and procedure, infection control, emergency care services, pharmaceutical services, radiological services and standard facilities . The aim of the regulations is to improve and protect the public by controlling the quality of the healthcare services received.

A recent study entitled “Compliance to Private Healthcare Facilities and Services Act and Regulations amongst Primary Care Private Clinics in a State in Malaysia” by  Ezat et al published in the year 2015 showed worrying trends with regard to compliance.  More than half the clinics in the survey did not meet the criteria of ‘good compliance’. Out of the 515 clinics audited only 45.0% fell under the category of good compliance, while 31.8% were categorised as moderate and 23.1% categorised as poor.  The findings of this study highlight that the compliance level among the private healthcare providers is still far from satisfactory.

We would like to call on the authorities to undertake regular scheduled audits and inspection on all private healthcare facilities. The Ministry of Health should in fact disclose publicly details of how frequently audits of private healthcare facilities have been conducted and the outcome.  This task should be taken seriously as it involves the health and safety of patients.

Letter to Editor, 17 August 2016