Tylenol Tragedy

Presented By Rahul Singh Meena (PM/2012/406) Bhavesh Mor (PM/2012/407) Phani Sirisha Bandla (PM/2012/411)

Table of content:
Introduction The Tragedy The Hay Days Measures taken Recovery and change in the law

Introduction
Johnson & Johnson formed by Robert Wood Johnson, James Wood & Edward Mead Johnson in 1985, is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturing corporation.

The corporation includes 250 subsidiary companies with operations in over 57 countries and products sold in over 175 countries.

 Tylenol is an American brand of drugs advertised for reducing pain, reducing fever, and relieving the symptoms of allergies, cold, cough, andflu. The active ingredient of its original flagship product is acetaminophen, an analgesic and antipyretic; it is commonly known elsewhere in the world by its international nonproprietary name, paracetamol

 The Chicago Tylenol murders occurred when seven people died after taking painrelief medicine capsules that had been poisoned. The poisonings took place in September and early October 1982, in the Chicago area of the United States.

 These poisonings involved Extra Strength Tylenol capsules, manufactured by McNeil Consumer Healthcare, which had been laced with potassium cyanide. The incidents led to reforms in thepackaging of over-thecounter substances and to federal anti-tampering laws. The case remains unsolved and no suspects have been charged. A $100,000 reward, offered by Johnson & Johnson, McNeil's parent company, for the capture and conviction of the "Tylenol Killer", has never been claimed.

 The Tragedy
On the morning of September 29, 1982, twelve-year-old Mary Kellerman of Elk Grove Village, Illinois, died after taking a capsule of Extra-Strength Tylenol. Adam Janus of Arlington Heights, Illinois, died in the hospital shortly after. Adam's brother Stanley of Lisle, Illinois, and sister-in-law Theresa died after gathering to mourn his death, having taken pills from the same bottle. Soon afterward, Mary McFarland of Elmhurst, Illinois, Paula Prince of Chicago, and Mary Reiner of Winfield, also died in similar incidents. Investigators soon discovered the Tylenol link. Urgent warnings were broadcast, and police drove through Chicago neighbourhoods issuing warnings over loudspeakers.

 As the tampered-with bottles came from different factories, and the seven deaths had all occurred in the Chicago area, the possibility of sabotage during production was ruled out.

Instead, the culprit was believed to have entered various supermarkets and drug stores over a period of weeks, removed packages of Tylenol from the shelves, adulterated their contents with solid cyanide compound at another location, and then replaced the bottles.

The Hay Days

Before the crisis, Tylenol was the most successful over-the-counter product in the United States with over one hundred million users.
Tylenol was responsible for 19 percent of Johnson & Johnson's corporate profits during the first 3 quarters of 1982. Tylenol was the absolute leader in the painkiller field accounting for a 37 percent market share, outselling the next four leading painkillers combined, including Anacin, Bayer, Bufferin, and Excedrin.

Measures taken
Johnson & Johnson distributed warnings to hospitals and distributors and halted Tylenol production and advertising. On October 5, 1982, it issued a nationwide recall of Tylenol products; an estimated 31 million bottles were in circulation, with a retail value of over US $100 million. The company also advertised in the national media for individuals not to consume any products that contained acetaminophen. When it was determined that only capsules were tampered with, Johnson & Johnson offered to exchange all Tylenol capsules already purchased by the public with solid tablets.

Recovery and change in the Law

Within five months of the disaster, the company had recovered 70% of its market share for the drug - and the fact this went on to improve over time showed that the company had succeeded in preserving the long term value of the brand. The incidents led to reforms in the packaging of overthe-counter substances and to federal anti-tampering laws.

 The Federal Anti-Tampering Act of 1983 (Act) makes it a federal criminal offense to tamper with consumer products or to engage in related conduct Under the Act, a person commits a federal criminal offense if he or she tampers with or attempts to tamper with any consumer product that affects interstate or foreign commerce.

A consumer product includes food, drugs, devices, cosmetics, and any other household product that is consumed by individuals or that is used for personal care or for household services

Conclusion:
J & J reacted responsibly to the chaos. The life of many people can be saved if the laws are framed properly prior its implementation.

Thank you

Pharma Disasters (Thalidomide Disaster, 1961)

Presented By Phani Sirisha Bandla (PM/2012/411) Rahul Singh Meena (PM/2012/406) Bhavesh Mor (PM/2012/407)

Contents
Introduction Timeline Adverse effects of Thalidomide Aftermath of the tragedy Compensation Regulations & Laws after Disaster Conclusion

Thalidomide
Thalidomide, launched by Chemie Grunenthal on 1st October 1957, was found to act as an effective tranquilizer and painkiller and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic which had an inhibitory effect on morning sickness, and so thousands of pregnant women took the drug to relieve their symptoms. Within a few years of the widespread use of thalidomide in Europe, Australia, and Japan, approximately 10,000 children were born with Phocomelia (absence or shortening of limbs), leading to the ban of thalidomide in most countries in 1961.

Effected Children

Timeline of Thalidomide Tragedy:

1954- Thalidomide was synthesized by Chemie Grunenthal 1957- Launched in Germany (Name: Contergan) 1958- Launched in UK (Name: Distaval) 1960- Became Over the counter drug in Germany because it proclaimed to that it had one remarkable property: overdoses simply caused prolonged sleep, not death. Nov1961- The Australian obstetrician William McBride and the German pediatrician Widukind Lenz suspected a link between birth defects and the drug, a theory Lenz proved in 1961. Nov 1961- In Germany and UK, thalidomide was withdrawn from the market Mar 1962- Banned in Canada May 1968- Criminal law suit against Chemie Grunenthal {The case was that they had put on sale a drug which caused an unacceptable degree of bodily harm without having tested it properly, and that they had failed to react to information on side effects in due time, and instead had tried to suppress information} Dec 1970- The court had its final session 2 years and nearly 7 months after its start. There was neither a sentence nor an acquittal

Effected children
The most common was flipper limbs in which the hand emerged direct from the shoulder and the foot direct from the hip. Babies also had internal injuries that required repeated operations to put right. Some appeared healthy but were deaf or blind or developed early signs of autism or epilepsy. One parent recalls: The doctor was crying and said my baby wouldnt live but he did. I didnt cry outwardly but inside I screamed. 20,000 (Germany-6000, UK-2000) babies were affected all over the world & 10,000 (Germany-3000, UK-466) of them survived. The early mortality rate among thalidomide babies was about 40%, largely as a result of serious internal malformations. The drug was sold in 16 European countries and another 30 around the world (Total-46) under 73 different brand names. Compound preparations which combined Thalidomide with other drugs were marketed for a wide variety of indications: Asmaval for asthma, Tensival for hypertension, Valgraine for migraine, and so forth.

Malformations attributable to the drug

Thalidomide causes harm to foetus when pregnant woman takes it in the critical period, i.e., from 27th to 40th day after conception.

Compensation for Effected people

UK: 1968- 1st settlement: Benefited 62 children for whom writs against Distillers company had been issued- 1 million. 1973 2nd settlement/agreement: Benefited 440 young people, who withdrew negligence claims against Distillers. Distillers paid seven annual installments of 2 million. The UK Government gave survivors a grant of 20 million, to be distributed through the Thalidomide Trust, in December 2009 Germany:

Grunenthal paid a voluntary sum of DM 114 million into the foundation. The Federal government of the day added another DM 100 million.

2800 people in Germany are entitled to receive benefits. Disabled Children

Relief Foundation paid out more than EUR 460 Million by the end of 2008.

Regulations & Laws after Disaster

Germany- Federal Ministry of Health (Germany) was founded (1962).
Establishing guidelines for the Manufacture, Clinical trial, Approval, Distribution channels and monitoring of medicines and medical devices.
The objectives are: Quality, Medical efficacy and Safety

United States- The Kefauver-Harris Amendment. Europe- Directive 65/65/EEC1 (Jan 26, 1965).
Was the first European pharmaceutical directive. The directive aimed at harmonizing standards for the approval of medicines within the then European Economic Community. The main article 3 of the directive requires that a Proprietary medicinal product could not be marketed within the community without prior authorization of the competent authority of at least one member state.

Dr. Frances Kelsey

She was a reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. The Thalidomide tragedy was averted in the United States because of the hold on its approval by Dr. Frances Kelsey of the U.S. Food and Drug Administration, who was recognized by President John F. Kennedy as a recipient of the Gold Medal Award for Distinguished Civilian Service. She played a key role in shaping and enforcing the 1962 Amendments. She also became responsible for directing the surveillance of drug testing at the FDA.

Kefauver-Harris Act
The U.S. Kefauver Harris Amendment /Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before : U.S. drug companies only had to show their new products were safe. After : An FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective. Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA.

 In order to address potential developmental and reproductive toxicities of pharmaceuticals, the U.S. FDA (1966) laid the foundation for the development of the Segment I (fertility and general reproduction), Segment II (teratogenicity), and Segment III (perinatal) testing protocol. Prior to the development of the segment I, II, and III testing protocols, toxicology testing was more hypothesis driven rather than a systematic bioassay testing strategy that is in place today.

The segment I, II, and III studies, or their International Conference on Harmonisation and Organisation for Economic Co-operation and Development equivalents, are performed in addition to routine shortterm, subchronic, and chronic toxicity assays and have been in place with little change for over 40 years.

Conclusion

The negative effects of thalidomide led to the development of more structured drug regulations and control over drug use and development. FDA controls the occurrence of disasters by following strict regulations.

References
http://toxsci.oxfordjournals.org/content/122/1/1.full http://www.thalidomide.ca/history-of-thalidomide/ http://guides.main.library.emory.edu/content.php?pid=156723&sid =132760 http://www.library.arizona.edu/exhibits/udall/congrept/87th/620 817.html http://www.contergan.grunenthal.info/grtctg/GRT.../152700081.jsp;.. http://en.wikipedia.org/wiki/Thalidomide http://news.bbc.co.uk/onthisday/hi/dates/stories/february/19/new sid_2566000/2566217.stm http://news.bbc.co.uk/onthisday/hi/dates/stories/december/13/ne wsid_2547000/2547825.stm