Petition to

President RI Ir. Joko Widodo

CAMPAIGN FOR A BETTER INDONESIA /

(klik di sini untuk versi Bahasa Indonesia)

#INDONESIABEBASKUTU

I.             BASIC HEALTH PRODUCTS FOR CHILDREN THAT CAN KILL, FROM A MONOPOLY, FREE FROM INDONESIAN LAWS AND REGULATIONS

I.1.         LINDANE: A SUBSTANCE THAT CAN KILL CHILDREN SOLD TO THEM ‘LIKE CHOCOLATES’ IN INDONESIA

In 2014, initially my child and subsequently my entire household got infested with head lice. As any mother would do, I turned to a pharmacy and enquired for a head lice treatment. I was offered PediTox (0.5% Hexachlorocyclohexane) with the comment this being the only choice in Indonesia.

This product was, however, also available on the internet, on the shelves of warungs and mini markets and was also quite literally sold without restrictions of any kind to children.

During a treatment of my family with PediTox (Lindane), my daughter fell severely ill from excruciating headaches. As this reaction appeared directly after the application of PediTox, I instinctively washed the product immediately out of her hair.

This event got me started to study all I could find about head lice treatments and Hexachlorocyclohexane, or Gameksan as it was referred to Indonesia as opposed to Lindane in the rest of the world.

Lindane is in fact so dangerous for humans that its use was reported by the US FDA to have caused the death in humans even when used in accordance with the US FDA’s tight regulations and limited product access.

Lindane is reported by the US FDA to be especially of health concerns, if used on children and people below a body weight of 50kg. Since 1995, Lindane was only available as prescription medication in the as ‘second line’ therapy against head lice after safer treatment options had failed.

In the US, the product was dispensed by a pharmacist limited to a single application and together with a medication guide providing detailed health warnings.

I.2.         LINDANE: MAY KILL YOUR CHILD, BUT NOT HEAD LICE, THE INTENDED TARGET ORGANISM

Before the incident of my daughter’s adverse reaction to PediTox Lindane, I had treated my household already twice. After each treatment of my entire household exactly per PediTox instructions, I combed the lice out of their hair and wiped the comb in-between with white kitchen tissue.

To my absolute surprise all the combed out lice started crawling again on the tissue after brief periods during which they appeared to be stunned to then fully recover again. I repeated the treatments with PediTox only because there was no other product choice in Indonesia except products only available on the internet that promised much and delivered nothing.

I only learnt subsequently through my own study that Lindane was for many years already globally reported to be ineffective against head lice due to resistance (immunity) buildup of these parasitic insects, if used as the only treatment over and over again over extended periods of time.

Between in the treatments with PediTox, growing despair let me also try a product from another Indonesian manufacturer with prominent market presence, mostly though through direct order or e commerce channels.

In the case of such manufacturer’s product, the combed out head lice refused to even show the courtesy of acting temporarily stunned. I also only learned later that such mentioned manufacturer’s product range contains to this day products sporting three different, mutually exclusive, fake Indonesian registration references, which may be indicative for the integrity on which its product claims are founded.

I.3.         ‘WATCH OUT FOR SSP’ INSIDE THE BOX MEANT TO WARN THAT A CHILD CAN DIE?

In Indonesia, anyone of any age, could buy practically unlimited quantities of PediTox Lindane anywhere until 2015 and tens of millions of Indonesians did. The product box deferred risk warnings to its leaflet insert of minimalistic content. The leaflet warned in its brief adverse reaction section of skin irritations and ‘SSP’.

How many mothers will have felt urged by the product packaging to take a closer look at SSP and then have deciphered the below meaning?

‘Your child is at risk of serious harm or death, if Gameksan can enter your child’s bloodstream amongst others, if your child:

•       Has open sores on the scalp (from secondary infections); or

•       Has skin abrasions from scratching (common symptom of head lice infestations); or

•       Ingests Gameksan such as from repetitive touching of the hair during the hours long treatment and licking of fingers;

•       And so on?’

I.4.         REBRANDING OF LINDANE AS INDONESIA’S VERY OWN GAMEKSAN: A COVER FOR A BANNED SUBSTANCE REBORN AS MEDICINE?

Since Keputusan Menteri Pertanian Nomor 434.1/Kpts/TP.270/7/2001 tentang Syarat dan Tatacara Pendaftaran Pestisida, Lindane was banned from all uses in Indonesia.

Was the term Gameksan invented to bypass Indonesia’s fresh Lindane ban when PediTox was reregistered by B POM as ‘over the counter medicine’ with Registration No. DTL7204128341A1 in 2002?

Were the inexplicably detailed explanations of the death of a head louse from PediTox (when compared against risk warnings for humans) designed to argue the products qualification as medicine? A medicine must contain an active substance, in-which the working mechanism alters the pathological or physiological state of the target organism.

But did prevailing Indonesian regulations not define clearly that this target mechanism is human, not a louse?

I.5.         SINCE 2009, WHEN INDONESIA RATIFIED THIS INTERNATIONAL ENVIRONMENTAL TREATY INTO NATIONAL LAW, REPORTED IMPORTS OF LINDANE INTO INDONESIA SOARED TO NEW HEIGHTS (1,000+ TONS)

In 2009, Lindane was added to the list of persistent pollutants under the United Nations Stockholm Convention, the same year when Indonesia ratified this international environmental treaty into national law by Undang-Undang Nomor 19 Tahun 2009 tentang Pengesahan Stockholm Convention On Persistent Organic Pollutants (Konvensi Stockholm tentang Bahan Pencemar Organik Yang Persisten) (Lembaran Negara Republik Indonesia Tahun 2009 Nomor 89, Tambahan Lembaran Negara Republik Indonesia Nomor 502).

Reported imports of Lindane into Indonesia on the other hand went to new heights in aggregate since this year (>1,000 tons).

I.6.         PEDITOX LINDANE SINCE 2010 BY REGULATION IN NO UNCERTAIN TERMS A PESTICIDE-BASED HOUSEHOLD PRODUCT, NOT A MEDICINE, BUT WHO CARES ABOUT REGULATIONS

Since Peraturan Menteri Kesehatan Nomor 1190/Menkes/Per/VIII/2010 tentang Izin Edar Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga, PediTox should have been pulled from circulation as medicinal product and reregistered as as pesticide-based household product, provided issuance of a pesticide license.

A new pesticide license for a substance that was newly globally outlawed could have been challenging. The change in product categorization would also have required a change of manufacturing permit.

Could this have been connected in any way with PediTox’ continued triumph as Indonesia’s only head lice product, registered by B POM as medicine (which cures humans) instead of by BINFAR and the Center for Plant Variety Protection and Agriculture Licensing as pesticide-based household product (which kills head lice)?

I.7.         LINDANE CAN CAUSE SERIOUS HARM OR KILL, EXCEPT IN INDONESIA, IF NAMED GAMEKSAN

1,112 tons of Lindane (sufficient to kill the entire population of Indonesia several times over) are reported to have been imported by Indonesia since PediTox’ registration in 2002. No other product to contain Lindane is published in Indonesia since. Lindane has caused abundantly published harm to the health of humans and to our environment the world all over that it was banned globally.

Yet no adverse reaction reports are published for Gameksan or PediTox. Is it plausible that Lindane has killed despite exponentially stricter access limitations and risk warnings in the US, and Indonesia just got lucky?

Or could this have anything to do with the absence of appropriate risk warnings, directions to immediately consult a doctor at the onset of adverse reactions, nor directions to report anything to anybody?

I.8.         PERMETHRIN: THE NEXT PESTICIDE ‘UNDERCOVER’ AS MEDICINE FROM THE SAME MONOPOLY SOURCE

In 2015, B POM registered PediTox under DTL 7204128341A1 with the pesticide Permethrin in replacement of Lindane. Permethrin has also been globally reported to be susceptible to resistance buildup by head lice and is toxic to aquatic life. Indonesian regulations have not changed though.

This product is the mirror image of a pesticide-based household product subcategory under the authority of BINFAR / Center for Plant Variety Protection and Agriculture Licensing, and not a medicine under authority of B POM.

So why did none of the said authorities care unless this would have anything to do with the conscious giving of benefits (e.g. product can be manufactured in facility with wrong manufacturing license, pesticide license requirement can be bypassed, etc.)?

If a party on one end of the table gives repetitively favors of considerable economic benefit in breach of applicable laws and regulations the the party on the other end, is it plausible to assume that no favors in any shape or form were returned?

What is the nature of the relationships between B POM and PediTox marketer which caused the regulator actually in charge (BINFAR) to push Krea Asia’s product registration submission bare any regulatory basis to B POM by mere reference to PediTox?

II.            REGULATORS AS FACILITATORS OF PEDITOX MONOPOLY ABOVE THE LAW

II.1.        B POM & BINFAR: REGULATORS NOT BOTHERING ABOUT REGULATIONS TO THE RESCUE OF PEDITOX MONOPOLY

In 2014, I co-founded a company, Krea Asia, to bring modern, neurotoxic pesticide-free head lice treatment products to Indonesia and to socialize knowledge about effective, health & environmental impact aware treatments. Since May 2015, Krea Asia has been attempting to register such products with the health authorities of Indonesia.

After my family was harmed by Indonesian health authorities by exposure to an inefficient, highly dangerous head lice treatment product that should have no longer been in circulation, my family was harmed a second time (this time financially) by Indonesian health authorities with intent. Krea Asia was caused to incur significant financial losses from numerous maneuvers by Indonesian health authorities to prevent market access of Krea Asia’s safe and efficacious head lice treatment products.

Indonesian health authorities were not shy to confirm in writing PediTox’ non-compliance with Indonesian regulations. Krea Asia’s proven products (by international market history in many countries of the world, by published clinical studies, by numerous regulator approvals and even independent regulator studies) were on the other hand prevented from registration on grounds of being ‘too harmless’ (i.e. not containing chemical pesticides).

So Lindane could be sold like chocolates to children or their unsuspecting parents at risk of killing children without compliant pesticide registration (of course without, because it was banned) and nothing to worry about for the Lindane repeat exposure-hardened, parasitic communities infesting our children’s heads. Safe & sound products that were tested around the globe raise alerts for Indonesian regulators to play every trick in the book of prevent or delay tactics. Who are these regulators serving with which objectives, and what gives them such levels of impunity?

II.2.        CENTER FOR PLANT VARIETY PROTECTION AND AGRICULTURE LICENSING: PLAYING ON THE SAME TEAM WITH B POM & BINFAR

Instead of a product registration, Krea Asia received ‘unregulated product rulings’ from B POM/BINFAR/Center for Plant Variety Protection and Agriculture Licensing as market authorization for NeutraLice Advance Lotion. As subsequent events proved, this arbitrary market authorization primarily served one purpose: the arbitrary liberty to revoke or cast doubts of the continued force and effect of such arbitrary rulings.

II.3.        TRUE PURPOSE OF REGULATOR RULING LETTERS INSTEAD OF REGISTRATIONS: CAN ONLY BE UNDERSTOOD BY ME AS TRAPS AND BLACKMAIL IN DEFENSE OF PEDITOX MONOPOLY

Following receipt of relevant ruling letters Krea Asia ordered 25,000 pieces of 475ml NeutraLice Advance Lotion from its Australian manufacturer. At the same time Krea Asia continued to pursue lawful product registration for this proven safe and efficacious product in Indonesia.

Progressing from arbitrary rulings to full legality assurance by way of product registrations is paramount to be able to serve the Indonesian market with newly developed packaging concepts to serve the millions of Indonesians suffering from head lice with pesticide-free products that work and meet all wallet sizes.

After all 25,000 pieces (or 30 pallets) of 475 ml NeutraLice Advance Lotion were manufactured in full compliance with relevant regulator rulings, the Center for Plant Variety Protection and Agriculture Licensing exercised the design function of those arbitrary rulings, which is to take them away again based on equally arbitrary decisions.

In Krea Asia’s case the threat not to be able to import the remainder 25 pallets after an initial shipment of 5 pallets, and in any event not to be permitted to distribute our fully paid products, was directly linked to Krea Asia’s continued insistence on legality assured product registration for such future orders.

In such case, NeutraLice Advance Lotion’s pesticide-ingredient free formulation would first have to pass tests pursuant to Indonesia’s Pesticide Regulation (Peraturan Menteri Pertanian RI Nomor 39/Permentan/SR.330/7/2015).

So banned, deadly pesticides for application on children, including my own daughter, without the process for which the Pesticide Regulation was created is OK by the Center for Plant Variety Protection and Agriculture Licensing. A proven safe, pesticide-free product that actually kills head lice, instead of accidentally the host, rings alerts of the Center for Plant Variety Protection and Agriculture Licensing to contradict its very own previous ruling.

Well, as alternative, I was previously offered by B POM to sell NeutraLice Advance Lotion with a cosmetics registration. There was one catch though, NeutraLice Advance Lotion would not have been allowed to claim killing head lice. Is anybody out there who believes there is no collusion and exchange of benefits at the disadvantage of an internationally proven new product to Indonesia at play?

II.4.        WORRIED BECAUSE SAFE AND EFFECTIVE PRODUCTS WITH PUBLISHED STUDIES REALLY EXIST?

NeutraLice Advance Lotion is by its generic formula reference 5% Benzyl Alcohol Lotion (5% BAL), a product that changed the world of head lice treatments since its first detailed description of a physical working mechanism-based head lice treatment in 2005 that is highly efficacious, free from the risk of tolerance build-up by head lice, health and environmentally impact conscious.

Since its initial head lice treatment product approval filings with the US FDA, 5% BAL went on to become the most successful head lice treatment product worldwide by number of national regulator approvals and aggregate population reach in such countries/regions (USA, European Union, Japan, Australia, etc.).

5% BAL’s benchmark scientific descriptions for a louse treatment approach targeting this parasite’s particular pathological weak spots with a formulation of only dermatological ingredients can be credited with having contributed to the development and commercial success of various other, toxin-free head lice treatment formulations. All of these modern products together have come to dominate the global developed head lice treatment market for their undeniable merits against chemical pesticides in only a few years since their invention.

III.             MONITOR AGENCIES YET TO START MONITORING / COMMISSION IX DPR RI OUT ON OTHER MISSIONS?

III.1.      OMBUDSMAN RI & KASN: MONITORS YET TO START MONITORING

I initiated legal filings with Ombudsman RI and KASN, each filing in conformance to the respective governing laws of each agency and supported by a full documentation dossier.

KASN replied (in contradiction to the law governing its authorities and obligations) not to be responsible and pointed at Ombudsman RI. Ombudsman RI has thus far not taken any step in accordance with the authorities granted to it and its obligations that would indicate its interest to initiate a substantive investigation.

Quite to the contrary, Ombudsman RI appears to be backing the position of the Center for Plant Variety Protection and Agriculture Licensing to hold Krea Asia’s fully legitimate trade inventory as hostage in response to its continued product registration efforts.

III.2.      COMMISSION IX (HEALTH) DPR RI: ANYBODY THERE?

In response to all of the above, I submitted summary documents to Commission IX DPR RI. No response was ever received, nor indication that anybody would do anything.

IV.            PETITION CONCLUSIONS AND REQUESTS FROM PRESIDENT IR. JOKO WIDODO

!V.1.      Inherited legacy burden of the government of President Ir. Joko Widodo at risk of becoming part of his legacy unless urgently needed changes happen

-              Impunity for a banned, deadly pesticide (Lindane) sold like chocolates to unsuspecting parents and children in a basic health product that did not even work.

-              Continued monopoly reign of prior Lindane-, now Permethrin-based product over an entire basic health product sub category from a vantage point of registration in the wrong product category by the wrong regulator.

-              Confidence and ease with which involved government bodies use every trick in the book to prevent modern, safe and efficacious health products with proven international history in regulated head lice category.

-              Parallel world of fake products with big promises, none kept.

-              Head lice myths, stigma, stereotypes and bullying in replacement of facts and empathy.

-              > 50 million Indonesians suffering from head lice denied access with intent to at least ONE PRODUCT that works and can back this claim up with published evidence.

VI.2.      I ask your support to petition President Ir. Joko Widodo to:

A.         Facilitate expeditious confirmation that Krea Asia’s 25 pallets of legitimately manufactured Neutralice Advance Lotion are free to be imported from Australia.

B.         Facilitate expeditious product registrations without further fabricated roadblocks for stalled new products (based on globally renown 5% BAL) to reach millions of Indonesians.

C.         Trigger investigation by Corruption Eradication Commission, the National Police or any competent government body to investigate the addressed mockery with basic health products for Indonesian children.

D.         Facilitate transparent processes for a level playing field between all health products market participants without blind spots by regulators.

This petition is launched through www.change.org​ www.indonesialebihbaik.org and www.abetterindonesia.org all of which are linked with the same petition supporter database for the avoidance of supporter double voting.

The English version of this petition is an unauthorized translation of the Bahasa language original. In the event of any discrepancy between the English and the Bahasa version, the Bahasa version shall prevail.

A signed original of the petition document together with a memory device containing a dossier of support documents will be submitted to President RI Ir. Joko Widodo, copy to Prof. Dr. Pratikno, M.Soc.Sc., Minister of the Secretariate of State RI and to the Assistant Deputy Public Complaint of the Secretariate of State RI. Many of the said dossier documents are already made available for download by anyone under http://www.krea-asia.com/uploads-en.html Other relevant documents will be made available shortly.

None of the statements contained in this petition are intended to express any political views, nor to be derogative in nature against anyone.

Kristi Wulan Cynthia

Jakarta, 14 November 2016

On behalf of tens millions of Indonesians deprived of their right of access to basic, proven safe & efficacious health products that are registered by responsibly acting health authorities and are free from collusion