tylenol and thalidomide tragedy

7/27/2019 Tylenol and Thalidomide Tragedy

1/29

Tylenol Tragedy

Presented ByRahul Singh Meena (PM /2012/406)Bhavesh Mor (PM /2012/407)

Phani Sirisha Bandla (PM /2012/411)


2/29

Table of content:

Introduction The Tragedy The Hay Days Measures taken Recovery and change in the law


3/29

Introduction Johnson & Johnson formed by Robert Wood

Johnson, James Wood & Edward Mead Johnson in1985, is an American multinational pharmaceutical ,medical devices and consumer

packaged goodsmanufacturing corporation.

The corporation includes 250 subsidiary companies with operations in over 57 countries and productssold in over 175 countries.
http://en.wikipedia.org/wiki/Multinational_corporationhttp://en.wikipedia.org/wiki/Pharmaceuticalhttp://en.wikipedia.org/wiki/Medical_devicehttp://en.wikipedia.org/wiki/Medical_devicehttp://en.wikipedia.org/wiki/Pharmaceuticalhttp://en.wikipedia.org/wiki/Multinational_corporation


4/29

Tylenol is an American brand of drugs advertisedfor reducing pain , reducing fever , and relieving thesymptoms of allergies , cold , cough , and flu .

The active ingredient of its original flagship productis acetaminophen , an analgesic and antipyretic ; it iscommonly known elsewhere in the world by its international nonproprietary name , paracetamol
http://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/Brandhttp://en.wikipedia.org/wiki/Drughttp://en.wikipedia.org/wiki/Analgesichttp://en.wikipedia.org/wiki/Feverhttp://en.wikipedia.org/wiki/Allergyhttp://en.wikipedia.org/wiki/Common_coldhttp://en.wikipedia.org/wiki/Coughhttp://en.wikipedia.org/wiki/Fluhttp://en.wikipedia.org/wiki/Paracetamolhttp://en.wikipedia.org/wiki/Analgesichttp://en.wikipedia.org/wiki/Antipyretichttp://en.wikipedia.org/wiki/International_Nonproprietary_Namehttp://en.wikipedia.org/wiki/Paracetamolhttp://en.wikipedia.org/wiki/Paracetamolhttp://en.wikipedia.org/wiki/International_Nonproprietary_Namehttp://en.wikipedia.org/wiki/International_Nonproprietary_Namehttp://en.wikipedia.org/wiki/International_Nonproprietary_Namehttp://en.wikipedia.org/wiki/International_Nonproprietary_Namehttp://en.wikipedia.org/wiki/Antipyretichttp://en.wikipedia.org/wiki/Analgesichttp://en.wikipedia.org/wiki/Paracetamolhttp://en.wikipedia.org/wiki/Fluhttp://en.wikipedia.org/wiki/Coughhttp://en.wikipedia.org/wiki/Common_coldhttp://en.wikipedia.org/wiki/Allergyhttp://en.wikipedia.org/wiki/Feverhttp://en.wikipedia.org/wiki/Analgesichttp://en.wikipedia.org/wiki/Drughttp://en.wikipedia.org/wiki/Brandhttp://en.wikipedia.org/wiki/United_States


5/29

The Chicago Tylenol murders occurred when seven people died after taking pain-relief medicine capsules that had been poisoned.The poisonings took place in September andearly October 1982, in the Chicago area of the

United States.
http://en.wikipedia.org/wiki/Capsule_(pharmacy)http://en.wikipedia.org/wiki/Chicago_metropolitan_areahttp://en.wikipedia.org/wiki/Chicago_metropolitan_areahttp://en.wikipedia.org/wiki/Capsule_(pharmacy)


6/29

These poisonings involved ExtraStrength Tylenol capsules, manufactured by McNeilConsumer Healthcare , which had been laced with potassium cyanide .

The incidents led to reforms in the packaging of over-the-counter substances and to federal anti-tampering laws.

The case remains unsolved and no suspects have beencharged. A $100,000 reward, offered by Johnson &Johnson , McNeil's parent company, for the capture andconviction of the "Tylenol Killer", has never beenclaimed.
http://en.wikipedia.org/wiki/Tylenolhttp://en.wikipedia.org/wiki/McNeil_Laboratorieshttp://en.wikipedia.org/wiki/McNeil_Laboratorieshttp://en.wikipedia.org/wiki/Potassium_cyanidehttp://en.wikipedia.org/wiki/Packaginghttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Johnson_&_Johnsonhttp://en.wikipedia.org/wiki/Johnson_&_Johnsonhttp://en.wikipedia.org/wiki/Johnson_&_Johnsonhttp://en.wikipedia.org/wiki/Johnson_&_Johnsonhttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Over-the-counter_substancehttp://en.wikipedia.org/wiki/Packaginghttp://en.wikipedia.org/wiki/Potassium_cyanidehttp://en.wikipedia.org/wiki/McNeil_Laboratorieshttp://en.wikipedia.org/wiki/McNeil_Laboratorieshttp://en.wikipedia.org/wiki/Tylenol


7/29

The Tragedy

On the morning of September 29, 1982, twelve-year-old Mary Kellerman of Elk Grove Village, Illinois , died after taking acapsule of Extra-Strength Tylenol.

Adam Janus of Arlington Heights, Illinois , died in thehospital shortly after. Adam's brother Stanley of Lisle, Illinois ,and sister-in-law Theresa died after gathering to mourn hisdeath, having taken pills from the same bottle.

Soon afterward, Mary McFarland of Elmhurst, Illinois , PaulaPrince of Chicago, and Mary Reiner of Winfield , also died insimilar incidents.

Investigators soon discovered the Tylenol link. Urgent warnings were broadcast, and police drove through Chicagoneighbourhoods issuing warnings over loudspeakers.
http://en.wikipedia.org/wiki/Elk_Grove_Village,_Illinoishttp://en.wikipedia.org/wiki/Arlington_Heights,_Illinoishttp://en.wikipedia.org/wiki/Lisle,_Illinoishttp://en.wikipedia.org/wiki/Lisle,_Illinoishttp://en.wikipedia.org/wiki/Elmhurst,_Illinoishttp://en.wikipedia.org/wiki/Winfield,_Illinoishttp://en.wikipedia.org/wiki/Winfield,_Illinoishttp://en.wikipedia.org/wiki/Elmhurst,_Illinoishttp://en.wikipedia.org/wiki/Lisle,_Illinoishttp://en.wikipedia.org/wiki/Arlington_Heights,_Illinoishttp://en.wikipedia.org/wiki/Elk_Grove_Village,_Illinois


8/29

As the tampered-with bottles came from differentfactories, and the seven deaths had all occurred in theChicago area, the possibility of sabotage duringproduction 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 compoundat another location, and then replaced the bottles.


9/29

The Hay Days

Before the crisis, Tylenol was the most successful over-the-counterproduct in the United States with over one hundred million users.

Tylenol was responsible for 19 percent of Johnson & Johnson'scorporate profits during the first 3 quarters of 1982.

Tylenol was the absolute leader in the painkiller field accounting fora 37 percent market share, outselling the next four leadingpainkillers combined, including Anacin, Bayer, Bufferin, andExcedrin.


10/29

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 Tylenolproducts; 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 thatcontained acetaminophen .

When it was determined that only capsules were tampered with, Johnson & Johnson offered to exchange all Tylenolcapsules already purchased by the public with solid tablets.


11/29

Recovery and change in the Law

Within five months of the disaster, the company hadrecovered 70% of its market share for the drug - and thefact this went on to improve over time showed that thecompany had succeeded in preserving the long term value of the brand.

The incidents led to reforms in the packaging of over-the-counter substances and to federal anti-tamperinglaws.


12/29

The Federal Anti-Tampering Act of 1983 (Act)

makes it a federal criminal offense to tamper withconsumer products or to engage in related conduct

Under the Act, a person commits a federal criminaloffense if he or she tampers with or attempts totamper with any consumer product that affectsinterstate or foreign commerce.

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


13/29

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.


14/29

Thank you


15/29

Pharma Disasters(Thalidomide Disaster, 1961)

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


16/29

Contents

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


17/29

Thalidomide Thalidomide, launched by Chemie Grunenthal on 1st October 1957, was

found to act as an effective tranquilizer and painkiller and was proclaimeda "wonder drug" for insomnia, coughs, colds and headaches.

It was also found to be an effective antiemetic which had an inhibitoryeffect on morning sickness, and so thousands of pregnant women tookthe 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 withPhocomelia (absence or shortening of limbs), leading to the ban of thalidomide in most countries in 1961.


18/29

Effected Children


19/29

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, atheory 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 unacceptabledegree of bodily harm without having tested it properly, and that they had failedto react to information on side effects in due time, and instead had tried tosuppress 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


20/29


21/29

Malformations attributable to the drug

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


22/29

Compensation for Effected peopleUK:

1968- 1 st settlement : Benefited 62 children for whom writs against Distillerscompany had been issued- 1 million .

1973 2nd settlement/agreement: Benefited 440 young people, who withdrewnegligence 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. TheFederal government of the day added another DM 100 million .

2800 people in Germany are entitled to receive benefits. Disabled ChildrenRelief Foundation paid out more than EUR 460 Million by the end of 2008.


23/29

Regulations & Laws after Disaster

Germany - Federal Ministry of Health (Germany) was founded (1962).

Establishing guidelines for the Manufacture, Clinical trial, Approval, Distributionchannels 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 harmonizingstandards for the approval of medicines within the then European EconomicCommunity.

The main article 3 of the directive requires that a Proprietary medicinal product couldnot be marketed within the community without prior authorization of the competent

authority of at least one member state.


24/29

Dr. Frances Kelsey

She was a reviewer for the U.S. Food and DrugAdministration (FDA) who refused toauthorize thalidomide for market because shehad concerns about the drug's safety.

The Thalidomide tragedy was averted in theUnited States because of the hold on itsapproval by Dr. Frances Kelsey of the U.S.Food and Drug Administration, who wasrecognized by President John F. Kennedy as a

recipient of the Gold Medal Award forDistinguished Civilian Service .

She played a key role in shaping and enforcingthe 1962 Amendments. She also becameresponsible for directing the surveillance of drug testing at the FDA .


25/29


26/29

In order to address potential developmental and reproductive toxicities of pharmaceuticals, the U.S. FDA (1966) laid the foundation for thedevelopment 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 systematicbioassay testing strategy that is in place today.

The segment I, II, and III studies, or their International Conference onHarmonisation and Organisation for Economic Co-operation andDevelopment equivalents, are performed in addition to routine short-term, subchronic, and chronic toxicity assays and have been in place withlittle change for over 40 years.
http://toxsci.oxfordjournals.org/content/122/1/1.fullhttp://toxsci.oxfordjournals.org/content/122/1/1.full


27/29

Conclusion

The negative effects of thalidomide led to the developmentof more structured drug regulations and control over drug

use and development. FDA controls the occurrence of disasters by following strict regulations.


28/29

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/grt-

ctg/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


29/29

tylenol and thalidomide tragedy

Documents