Tylenol Article in Forbes

Kelly Clark (fuzzbutt(AT)jane.penn.com)
Thu, 19 Mar 1998 09:06:56 -0800

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Hello Everyone,
I hope I have gotten the correct article in Forbes about Tylenol. I
thought this was very interesting and never new there were these many
dangers w/ Tylenol. I put the graph in this article and also as an
attatchement in case it didn't turn out for some.
Kelly Rods Mom
Bradford PA

When You've Got An Ache
Tylenol rules the market for
branded nonprescription
headache, fever, allergy and
cold remedies. These figures
cover retail U.S. sales in only
certain outlets.

[Image]

Despite bad publicity and costly legal settlements,
Johnson & Johnson refuses to put ample
warnings on its Tylenol labels.

J&J's dirty little secret

By Thomas Easton and Stephen Herrera

IT WAS JUST AFTER the 1989 winter
holidays. Lacy Keele, a 5-year-old living in rural
Louisiana, was given a common remedy for the
common flu: Tylenol. Only she got too much: four
extra strength tablets in one day, her mother said,
or twice what a child should receive. The
overdose destroyed Lacy's liver. Within a week
she was dead.

A jury found Tylenol to be a cause in her death,
but it let Tylenol's manufacturer, Johnson &
Johnson, off because her parents were
adequately informed of the risks. Risks with
Tylenol? The product's advertising slogan, after
all, was: "Nothing's safer."

J&J won the legal skirmish-but the war is not
over. In the eight years since Lacy died, there
have been hundreds of fatalities and serious liver
injuries attributed to acetaminophen, the active
ingredient in Tylenol. J&J has paid out millions of
dollars in legal settlements. A handful of these
cases have drawn coverage in newspaper and
television stories. The word is beginning to get
out that, safe though it is in proper doses, Tylenol
can be very dangerous indeed in doses not much
greater.

Sophie Regosin-Hodges was 14 months old
when an overdose of Tylenol almost killed her.
Sophie's mother gave her Tylenol infant
drops-but, acting under instructions from a
pediatrician, used the dosage for a different
product, Tylenol children's suspension liquid.
You'd never know it from looking at the
packages (see photo, p. 44), but the infant drops
are three times as potent as the children's
formula.

Sophie is 4 years old now. She survives by dint
of a transplant of liver tissue from her father. She
will be on immunosuppressant drugs all her life.

Mary Rose Palmison was a moderate drinker
and regularly took Tylenol for back pain. In late
1993 she checked into a hospital suffering from
nausea. A month later she was dead. According
to the complaint in a case that J&J has settled for
an undisclosed sum, Tylenol poisoning caused her
liver to fail.

Antonio Benedi, then a 37-year-old aide to
George Bush, drank wine with dinner on a
Saturday night in 1993 and over the next four
days took ten extra strength Tylenol tablets,
hospital records show. He went into a coma and
was saved only by a liver transplant. He sued and
won $8 million from J&J.

We could go on. Our point is not that Tylenol is
too dangerous to sell-Americans take billions of
doses a year without suffering ill effects. The
question is simply one of disclosure. Has Johnson
& Johnson done all it could to publicize the
hazards? Shouldn't the label, which is full of
boilerplate about consulting physicians, be more
explicit?

J&J has made grudging concessions,
strengthening the warning label, a little at a time.
After the Keele case, J&J added to the extra
strength package: "Not for use in children." In
1994, after Benedi, it added a warning about
using any pain reliever if you drink. It is planning
to redo the confusingly similar packages on the
two very different versions of Tylenol for young
patients.

Still, J&J resists writing the kind of label that
would really wake people up to the dangers of
stepping over the line between permissible and
impermissible doses.

Why not warn about possible liver failure? J&J
says that "organ specific" warnings would confuse
people. Why not talk about the risk of death?
That would promote suicides, says the company:
If people knew that acetaminophen was
potentially deadly, they might find it a convenient
means for departing this world.

Acetaminophen, a
chemical vaguely
similar to aspirin in
molecular structure, has
all of aspirin's ability to
quell fevers and relieve
pain, but without
aspirin's tendency to
upset the lining of the
stomach. It also lacks a
side effect that makes
aspirin unsuitable for
children: the
one-in-a-million chance
that a child taking
aspirin during a spell of
flu or a cold will come
down with the
potentially fatal nervous
system complication
known as Reye's
syndrome.

The Johnson &
Johnson subsidiary
McNeil Consumer
Products Co. has been
selling Tylenol since
1955. It has brilliantly
marketed the limited
advantages of
acetaminophen over
aspirin. J&J has no
patent on the chemical,
which was first used in
Germany almost a
century ago. Yet it has
made Tylenol into a stunning moneymaker. Wall
Street analysts estimate J&J's revenue for Tylenol
at $1.3 billion a year. The fact that generic
acetaminophen is available at about half the price
suggests J&J's small profit margin is pretty hefty.

J&J spends a lot of that gross profit to strengthen
the brand. Advertising Age estimates the
company's domestic ad budget for Tylenol at
$250 million, more than Coca-Cola spends on
Coke. The money hasn't been wasted. Tylenol
holds an overwhelming share of the
acetaminophen market, and a 30% share of the
combined market for branded sniffle, headache
and fever remedies.

Which perhaps explains J&J's reluctance to make
people more aware of Tylenol's dark side. At
least 100 suits have been filed against Johnson &
Johnson over acetaminophen poisonings, half in
the past three years. In four cases we know of-in
Pennsylvania, Texas and Ohio-the company has
made out-of-court settlements under agreements
that require the plaintiffs to keep mum about the
terms.

Damning evidence was dredged up during the
trial over Benedi's near-death experience. In
1986 J&J polled several hundred people,
including doctors, on their reaction to a
hypothetical alcohol warning. Some 70% of the
respondents said they wouldn't recommend use
of the product for drinkers. In short, an alcohol
warning might have threatened J&J's market
share. Benedi's lawyers got a lot of mileage out of
that point.

In response to studies tying liver damage to the
use of acetaminophen and alcohol, Johnson &
Johnson drafted damage-control memos that also
came out in court. One told the company's sales
representatives: "Do not initiate discussions with
your physicians on this issue." The second
advocated: "diffusing media interest"-i.e., muddy
the waters.

It's a tricky business to keep your customers
from hurting themselves but not scare them away.
Here's a useful idea: Tell customers to keep a log
of doses taken. It's the cumulative dose over the
course of an illness that matters. With the help of
a log, a patient or a parent might notice that he
has gone too far and call a poison control center
in time to get help (see box, p. 42).

No, the log is not our idea, but J&J's. It is making
the recommendation in a patient education
brochure being sent to doctors. But the label says
nothing about keeping track of doses.

The fact is that people do tend to use Tylenol in a
casual fashion. Think about the circumstances:
You have a headache and take a few pills. It still
hurts so you take more. It's even worse with a
child whose fever may be stretching the outer
numbers on the thermometer at 3 a.m.

Under the circumstances, it just might make sense
for the manufacturer to do everything possible to
keep its customers on the safe side of the line. In
a study cited at a Food & Drug Administration
committee meeting in September, parents were
given a choice of measuring devices for
acetaminophen, the product label and the correct
weight of their child. Still, 70% measured out the
wrong dosage.

So what is on the label? A red-letter warning
about avoiding the product if the package has
been tampered with. This is a throwback to that
infamous episode in 1982 when a murderer
stuffed cyanide into Tylenol bottles.

Johnson & Johnson's adroit response to the
tampering incident became a classic business
school case study on corporate responsibility and
crisis management. A tamper-proof container
was introduced; J&J's then-chief executive James
Burke visibly took responsibility for public safety.
Burke brought a badly shaken consumer brand
back to life.

Contrast this forthrightness with J&J's
inch-by-inch concessions on label warnings about
liver damage. The cyanide killed seven people.
The American Association of Poison Control
Centers counts about 100 deaths a year from
acetaminophen alone or in combination.This
figure understates the total, since hospitals are not
required to report cases.

Burke's successor, Ralph Larsen, has a painful
choice. He can rewrite the label, putting on it the
verbal equivalent of a skull and crossbones. Or
he can go on paying off victims, and hope for the
best.

Which is the moral choice? Which, in the long
run, is the best business decision?

Sidebar:

Use as directed
What you don't know can kill you

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Hello Everyone,
    I hope I have gotten the correct article in Forbes about Tylenol. I thought this was very interesting and never new there were these many dangers w/ Tylenol. I put the graph in this article and also as an attatchement in case it didn't turn out for some.
Kelly Rods Mom
Bradford PA

          When You've Got An Ache
              Tylenol rules the market for
                   branded nonprescription
                   headache, fever, allergy and
                   cold remedies. These figures
                   cover retail U.S. sales in only
                   certain outlets.
 
 

Despite bad publicity and costly legal settlements,
 Johnson & Johnson refuses to put ample
 warnings on its Tylenol labels.

 J&J's dirty little secret

 By Thomas Easton and Stephen Herrera

 IT WAS JUST AFTER the 1989 winter
 holidays. Lacy Keele, a 5-year-old living in rural
 Louisiana, was given a common remedy for the
 common flu: Tylenol. Only she got too much: four
 extra strength tablets in one day, her mother said,
 or twice what a child should receive. The
 overdose destroyed Lacy's liver. Within a week
 she was dead.

 A jury found Tylenol to be a cause in her death,
 but it let Tylenol's manufacturer, Johnson &
 Johnson, off because her parents were
 adequately informed of the risks. Risks with
 Tylenol? The product's advertising slogan, after
 all, was: "Nothing's safer."

 J&J won the legal skirmish-but the war is not
 over. In the eight years since Lacy died, there
 have been hundreds of fatalities and serious liver
 injuries attributed to acetaminophen, the active
 ingredient in Tylenol. J&J has paid out millions of
 dollars in legal settlements. A handful of these
 cases have drawn coverage in newspaper and
 television stories. The word is beginning to get
 out that, safe though it is in proper doses, Tylenol
 can be very dangerous indeed in doses not much
 greater.

 Sophie Regosin-Hodges was 14 months old
 when an overdose of Tylenol almost killed her.
 Sophie's mother gave her Tylenol infant
 drops-but, acting under instructions from a
 pediatrician, used the dosage for a different
 product, Tylenol children's suspension liquid.
 You'd never know it from looking at the
 packages (see photo, p. 44), but the infant drops
 are three times as potent as the children's
 formula.

 Sophie is 4 years old now. She survives by dint
 of a transplant of liver tissue from her father. She
 will be on immunosuppressant drugs all her life.

 Mary Rose Palmison was a moderate drinker
 and regularly took Tylenol for back pain. In late
 1993 she checked into a hospital suffering from
 nausea. A month later she was dead. According
 to the complaint in a case that J&J has settled for
 an undisclosed sum, Tylenol poisoning caused her
 liver to fail.

 Antonio Benedi, then a 37-year-old aide to
 George Bush, drank wine with dinner on a
 Saturday night in 1993 and over the next four
 days took ten extra strength Tylenol tablets,
 hospital records show. He went into a coma and
 was saved only by a liver transplant. He sued and
 won $8 million from J&J.

 We could go on. Our point is not that Tylenol is
 too dangerous to sell-Americans take billions of
 doses a year without suffering ill effects. The
 question is simply one of disclosure. Has Johnson
 & Johnson done all it could to publicize the
 hazards? Shouldn't the label, which is full of
 boilerplate about consulting physicians, be more
 explicit?

 J&J has made grudging concessions,
 strengthening the warning label, a little at a time.
 After the Keele case, J&J added to the extra
 strength package: "Not for use in children." In
 1994, after Benedi, it added a warning about
 using any pain reliever if you drink. It is planning
 to redo the confusingly similar packages on the
 two very different versions of Tylenol for young
 patients.

 Still, J&J resists writing the kind of label that
 would really wake people up to the dangers of
 stepping over the line between permissible and
 impermissible doses.

 Why not warn about possible liver failure? J&J
 says that "organ specific" warnings would confuse
 people. Why not talk about the risk of death?
 That would promote suicides, says the company:
 If people knew that acetaminophen was
 potentially deadly, they might find it a convenient
 means for departing this world.

 Acetaminophen, a
 chemical vaguely
 similar to aspirin in
 molecular structure, has
 all of aspirin's ability to
 quell fevers and relieve
 pain, but without
 aspirin's tendency to
 upset the lining of the
 stomach. It also lacks a
 side effect that makes
 aspirin unsuitable for
 children: the
 one-in-a-million chance
 that a child taking
 aspirin during a spell of
 flu or a cold will come
 down with the
 potentially fatal nervous
 system complication
 known as Reye's
 syndrome.

 The Johnson &
 Johnson subsidiary
 McNeil Consumer
 Products Co. has been
 selling Tylenol since
 1955. It has brilliantly
 marketed the limited
 advantages of
 acetaminophen over
 aspirin. J&J has no
 patent on the chemical,
 which was first used in
 Germany almost a
 century ago. Yet it has
 made Tylenol into a stunning moneymaker. Wall
 Street analysts estimate J&J's revenue for Tylenol
 at $1.3 billion a year. The fact that generic
 acetaminophen is available at about half the price
 suggests J&J's small profit margin is pretty hefty.

 J&J spends a lot of that gross profit to strengthen
 the brand. Advertising Age estimates the
 company's domestic ad budget for Tylenol at
 $250 million, more than Coca-Cola spends on
 Coke. The money hasn't been wasted. Tylenol
 holds an overwhelming share of the
 acetaminophen market, and a 30% share of the
 combined market for branded sniffle, headache
 and fever remedies.

 Which perhaps explains J&J's reluctance to make
 people more aware of Tylenol's dark side. At
 least 100 suits have been filed against Johnson &
 Johnson over acetaminophen poisonings, half in
 the past three years. In four cases we know of-in
 Pennsylvania, Texas and Ohio-the company has
 made out-of-court settlements under agreements
 that require the plaintiffs to keep mum about the
 terms.

 Damning evidence was dredged up during the
 trial over Benedi's near-death experience. In
 1986 J&J polled several hundred people,
 including doctors, on their reaction to a
 hypothetical alcohol warning. Some 70% of the
 respondents said they wouldn't recommend use
 of the product for drinkers. In short, an alcohol
 warning might have threatened J&J's market
 share. Benedi's lawyers got a lot of mileage out of
 that point.

 In response to studies tying liver damage to the
 use of acetaminophen and alcohol, Johnson &
 Johnson drafted damage-control memos that also
 came out in court. One told the company's sales
 representatives: "Do not initiate discussions with
 your physicians on this issue." The second
 advocated: "diffusing media interest"-i.e., muddy
 the waters.

 It's a tricky business to keep your customers
 from hurting themselves but not scare them away.
 Here's a useful idea: Tell customers to keep a log
 of doses taken. It's the cumulative dose over the
 course of an illness that matters. With the help of
 a log, a patient or a parent might notice that he
 has gone too far and call a poison control center
 in time to get help (see box, p. 42).

 No, the log is not our idea, but J&J's. It is making
 the recommendation in a patient education
 brochure being sent to doctors. But the label says
 nothing about keeping track of doses.

 The fact is that people do tend to use Tylenol in a
 casual fashion. Think about the circumstances:
 You have a headache and take a few pills. It still
 hurts so you take more. It's even worse with a
 child whose fever may be stretching the outer
 numbers on the thermometer at 3 a.m.

 Under the circumstances, it just might make sense
 for the manufacturer to do everything possible to
 keep its customers on the safe side of the line. In
 a study cited at a Food & Drug Administration
 committee meeting in September, parents were
 given a choice of measuring devices for
 acetaminophen, the product label and the correct
 weight of their child. Still, 70% measured out the
 wrong dosage.

 So what is on the label? A red-letter warning
 about avoiding the product if the package has
 been tampered with. This is a throwback to that
 infamous episode in 1982 when a murderer
 stuffed cyanide into Tylenol bottles.

 Johnson & Johnson's adroit response to the
 tampering incident became a classic business
 school case study on corporate responsibility and
 crisis management. A tamper-proof container
 was introduced; J&J's then-chief executive James
 Burke visibly took responsibility for public safety.
 Burke brought a badly shaken consumer brand
 back to life.

 Contrast this forthrightness with J&J's
 inch-by-inch concessions on label warnings about
 liver damage. The cyanide killed seven people.
 The American Association of Poison Control
 Centers counts about 100 deaths a year from
 acetaminophen alone or in combination.This
 figure understates the total, since hospitals are not
 required to report cases.

 Burke's successor, Ralph Larsen, has a painful
 choice. He can rewrite the label, putting on it the
 verbal equivalent of a skull and crossbones. Or
 he can go on paying off victims, and hope for the
 best.

 Which is the moral choice? Which, in the long
 run, is the best business decision?

 Sidebar:

        Use as directed
        What you don't know can kill you
 
 
 
 
 
 
 
 
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