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Johnson &Johnson sold 1,61,000 Cancer-causing Baby Powder units from 2007 till 10. Can they be condoned?

13 August 2013 No Comment

RTI Activist News

Issued in public interest by RTI Activist Krishnaraj Rao.

This week, Bombay High Court will give a judgement in WPL 1714 of 2013, concerning cancellation of the licence of healthcare giant Johnson & Johnson for manufacturing cosmetics, including its Baby Powder, at its Mulund Plant. Because of media reports in TOI  and Economic Times, one worries that the court is unaware of the gravity of J&J’s crime:

(1)   Despatching 1,61,000 containers (17,000 kg) of Baby Powder into the market in June-Aug 2007, containing residues of a deadly carcinogen called Ethylene Oxide a.k.a. ETO or EO.

(2)   Not withdrawing the batch the talc (which boasts the FDA-approved claim “Clinically Proven Mild”) despite serious warnings by the company’s scientist Dr Ajit Telang about health and legal implications.

(3)   Knowingly exposing lakhs of infants and parents (especially breastfeeding mothers) to daily skin contact and respiration of carcinogenic ETO. This batch of carcinogenic talc was in the market till at least 2010.

(4)   Terminating Dr Ajit Telang, the whistle-blower, and covering up the matter.

Maharashtra Food and Drugs Administration (FDA) cancelled the licence on 29th June 2013, after a thorough investigation of the incident and the cover-up. FDA’s investigation report, finalized in March 2013, was procured under Right to Information by Dr Telang:  http://tinyurl.com/FDA-Report-on-J-J-Baby-Powder

Page 8 of FDA’s report says: “The unfortunate babies who were repeatedly exposed to the talcum powder of these Ethylene Oxide treated batches, which was highly advertised and claimed as “mild and clinically proven” product (actually this claim was developed for baby talcum powder in which steam sterilization was used) may develop slowly and silently disease of cancer… there are sometimes years between exposure to a carcinogen and development of cancer. Further, some of these victims may pass on the genetic mutations to next generations if they live longer.”

But it seems that the hon’ble judges are missing the point. They reportedly remarked during the hearing on 28th July that J&J’s offer to test the product appeared to be “reasonable” and proved its bonafide intentions. “The bench noted that FDA had not contended that the current stock of the baby powder was a problem or that prejudice would be caused to public interest,” says Economic Times. Further, it seems that the judges indicated their inclination to order that the Mulund plant’s licence should be restored if J&J shows willingness to test its powder for ETO residue.

Such a judgement would be a black day for India – a dangerous precedent that demonstrates that the lives of Indians – our lives and the lives of our children — are indeed very cheap. One ardently hopes that the High Court will not condone a man-made disaster that began in June-Aug 2007 and went on till 2010, which was in the words of the FDA, “an unpardonable crime”. Such a judgement would also be a huge setback to the regulatory clout of Food & Drugs Administration in India.

Knowingly selling toxic baby powder 161,000 trusting mothers is a crime that, even according to our FDA’s lax standards, is punishable with a year of imprisonment. Similar offences by healthcare companies abroad have attracted billions of dollars in penalties and damages, and also imprisonment of the concerned executives.

Last but not least, such a judgement would be a black day for whistleblower Dr Ajit Telang, who was victimized by the company. Dr Ajit Telang is a highly accomplished innovator and inventor. He holds a total of nine international patents/patent applications. No less than 5 Indian (IN186283, IN186284, IN187688, IN187689, IN190492), 1 European (EP1221325), 1 American (US2002197336), 1 Canadian (CA2367232) and 1 Australian (AU783366) were registered with Dr Telang’s name during the period of his tenure with Johnson & Johnson.

 

WHAT ARE THE CONCLUSIONS OF FDA’S REPORT? READ BELOW:

(English Translation)

(Page 12 onwards of this Marathi report: http://tinyurl.com/FDA-Report-on-J-J-Baby-Powder )

QUOTE

1) Since J&J conducted ETO processing of 15 Baby Powder batches illegally, the quality of these batches is not trustworthy.

2)15 batches of baby powder were released for distribution without testing the dangerous ingredients like “residual contents of ETO & Ethylene Chlorhydrin”

3) Ethylene Oxide process used for 15 Baby Powder batches  was not validated, however, the manufacturer sold the product  even though the quality & safety of these products cannot be confirmed/ guaranteed.

4) Since J&J changed the approved process, used carcinogenic ETO as ingredient in the processing without taking approval from FDA, did not inform FDA of this deviation, they have violated rule 18 C of Drug & cosmetics law. Hence under 27(A) the manufacturer is eligible for 1 year jail or penalty of up to Rs 1000/- or both.

5) Since J&J did not conduct test of “Dermatological Safety of new Raw material in an old formulation” as per IS 4011-1997 under schedule S (2) under Drug & Cosmetics act, manufacturer has violated rule 142 (B) which is “conditions of license” requirement. Since there are no trustworthy reports of Quality & Safety of the 15 batches of baby powder, it is an unpardonable crime and hence if found acceptable by law, the licensing authority of related area are proposing cancellation of manufacturing licence of the manufacturer.

6) The fact that, although the quality & Safety of 15 batches of Baby Powder could not be guaranteed, since it was found that the method used to determine ETO inside the product was not valid , the manufacturer did not recall the product on its own is very serious and hence the powder used for the babies was dangerous.

UNQUOTE

 

KILLING THE MESSENGER WHO BEARS BAD NEWS

FDA’s investigation was based on the complaint filed by Dr Ajit Telang’s complaint on J&J’s Credo Helpline filed in December 2009:http://tinyurl.com/Ajit-Telang-Complaint

Dr Telang didn’t just decide to turn into a whistleblower out of the blue. As a responsible employee of J&J, he was mandated to do so by the global policies and guidelines of Johnson & Johnson, specifically such as Policy on Business Conduct, as well as its Credo and its Safety & Care Commitment.

For his courageous action, Dr Ajit Telang was terminated by J&J on 15th October 2010.

Strange that this should happen at Johnson & Johnson, a multinational that claims, “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality…  You can rely on us to help keep baby fresh, sooth an irritating itch, or relieve an aching muscle… whatever your family’s health care needs, the Johnson & Johnson Family of Companies is at your side.”

 

DETAILS OF THE INCIDENT OF ETO-CONTAMINATED BABY POWDER

  • In December 2008, Dr Telang was shocked to discover that his superior, had instructed Operations to carry out Ethylene Oxide sterilization (a banned process of sterilization due to Ethylene Oxide being Carcinogenic) of 15 batches i.e. about 30,000 kgs. of baby powder packed in plastic containers (finished goods), which were found to be not meeting specification.
  • This work was outsourced to a facility run by Microtrol Pvt. Ltd. At Marol. The ETO contaminated powder was completed over a span of six days and released into the market without taking the following mandatory actions: (i) conducting validation of both process and the test method according to ISO 11135 , 10993 & 14971 (ii) conducting any stability study to estimate the residual Ethylene Oxide contents in the said powder (iii) taking approval from Corporate Office (J&J Inc.) for altering the regular process and (iv) informing the Food and Drug Administration (FDA) when the regular process, approved by FDA, was only steam sterilization.
  • Dr Telang immediately reported this grave error of judgment on the company’s website (J&J’s Credo Hotline). But no action was taken by the management to recall the product. Instead, a concerted effort began to silence Dr Telang and hush up the matter, and shield those who had perpetrated the crime. The head office sent officers from the Singapore office who enquired into the matter, but conspired in the cover-up.

 

DETAILS ABOUT WHISTLE BLOWER DR AJIT TELANG

 

  • Dr Ajit Telang, with a Doctorate in Polymer Science from University Department of Chemical Technology, a premier institute of India, and a Licentiate of Plastics & Rubber Institute, London, joined Johnson & Johnson as a Technical Services Officer, helped to develop many products over the decades, including Johnsonplast Extra Porous adhesive tape for hospitals, American Porous Plaster for pain relief for exports to Far East region, Band-Aid with various Disney characters, and Easy Tear Plastic Porous tape with bidirectional tear properties for hospitals, Band-Aid Turmeric and Band-Aid – Waterblock Fast Aid (opaque). Between 1996 and 2003, he received four global Awards for Big Ideas — the only person from India to receive these awards. In 2005, he received the Asia Pacific Award for Neutrogena Mask design — the only person from India to receive this award.

 

  • Ironically, in 2006, he worked on a Process Excellence (PE) project for elimination of Ethylene Oxide (ETO) sterilization for Band-Aid range of products. His work had a positive impact on the environment and resulted in eliminating usage of carcinogenic material in the plant, as well as substantial savings for the plant. For this, Dr Telang received the Process Green Belt and Vice President’s Award in Shanghai, China.

 

  • In the Woman’s Health Care (Sanitary Napkins) segment, between 2006 and 2010, Dr Telang helped to introduce Stayfree Secure Dry Wings, Stayfree Secure Cottony Wings, Stayfree Drymax Ultrathin Regular, Stayfree Drymax Ultrathin All Night and Stayfree Secure Ultrathin (mid-tier).
  • Dr Telang had completed a number of Cost Improvement Projects resulting in savings of approx. $1 Million for the year 2009 and $1.5 Million for the year 2010 upto Oct. 2010. A day before he was abruptly terminated, Dr Telang was informed by the GM Operations by SMS that he had received the Asia Pacific Award for the cost improvement project he was working on. He was holding the position of Technical Services Manager at the time he was terminated.

 

FOR DETAILS & DOCUMENTS, CONTACT:

  • Dr Ajit Telang 9323227247, atelang1@gmail.com
  • For an independent opinion on technical aspects of sterilization processes, risks associated with ETO and various products and processes, and its applicable regulations & global practices, you may contact Mr M S Prabhakar: http://tinyurl.com/MS-Prabhakar

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