- 6 months ago
The practice of pharmaceutical manufacturers marketing and influencing doctors to prescribe medications.
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00:00Funding for Frontline is provided by this station and other public television stations nationwide,
00:07and by the Corporation for Public Broadcasting.
00:11Pharmaceutical companies compete fiercely for a lion's share of the prescription drug market.
00:16The American public, they don't know.
00:18They don't know what the company will do to get the physicians to go ahead and prescribe a drug.
00:24Frontline investigates drug marketing methods and how doctors are influenced to prescribe and even promote drugs.
00:31These drugs were being promoted as quite good, quite effective, quite safe,
00:35when all the well-done scientific studies show that they were quite ineffective and in some cases dangerous.
00:40Tonight on Frontline, prescriptions for profit.
00:43From the network of public television stations,
00:55a presentation of KCTS Seattle,
00:58WNET New York,
00:59WPBT Miami,
01:01WTVS Detroit,
01:03and WGBH Boston,
01:06this is Frontline
01:07with Judy Woodruff.
01:13Good evening.
01:15Every year, Americans take more and more prescription drugs.
01:19If that's troubling news to some,
01:22it's good news for the pharmaceutical industry.
01:25The prescription drug market,
01:27now $30 billion a year,
01:29is one of the most intensely competitive in the country.
01:33Tonight, Frontline examines that competition
01:36and how prescription drugs are marketed
01:39to doctors and to patients.
01:41Tonight's program was produced and written by Elizabeth Arledge
01:46and reported by Joe Rosenblum.
01:49It is called
01:50Prescriptions for Profit.
01:57June 1969.
02:00Baseball great Mickey Mantle retires at age 36.
02:03It's been a great honor.
02:05I'll never forget it.
02:07God bless you all,
02:09and thank you very much.
02:16Mantle was an American legend,
02:18a hero to his fans,
02:20but injuries to his knees
02:21had forced him to give up the game.
02:24And now,
02:25so that Mickey's fans
02:26can bid him a personal farewell,
02:28he'll take one last turn
02:30around Yankee Stadium.
02:31In the years since his retirement,
02:41Mickey Mantle has become
02:42one of the 37 million Americans
02:44who suffer from arthritis.
02:49From NBC News.
02:51But in the summer of 1988,
02:53Mantle announced
02:53what sounded like a miracle.
02:55He appeared on NBC's Today show
02:57to endorse a new prescription drug
03:00for arthritis
03:00called Voltaren.
03:03Well, I didn't even know
03:03I had arthritis.
03:04Like I said,
03:05I thought I was just getting old
03:06until Dr. Greenberg told me that.
03:07And of course,
03:08when he put me on the program,
03:09it was to take Voltaren.
03:11So I've been on it about a year.
03:13Mantle said Voltaren
03:15had done wonders
03:15for the arthritis in his knees.
03:17But now I can play golf
03:19with almost painless, you know.
03:23It was a good story.
03:24A baseball star
03:25delivered from pain
03:26courtesy of what appeared
03:28to be a new wonder drug.
03:32Siba Geigy,
03:33the manufacturer of Voltaren,
03:35is the world's
03:36fourth largest drug company
03:37with annual sales
03:38of 11 and a half billion dollars.
03:41Voltaren has been
03:42on the European market
03:43since 1974.
03:45It has a good
03:45overall safety record.
03:47And Siba says
03:48it is the best-selling
03:50arthritis drug
03:51in the world.
03:52In the U.S.,
03:53Voltaren has captured
03:5450 million dollars worth
03:56of arthritis drug sales
03:57in just six months.
03:59That success is due
04:01partly to the testimonial
04:02of Mickey Mantle,
04:03who praised the new drug
04:05at every chance.
04:06Sports Channel presents
04:08New York Yankees baseball.
04:14Look at this.
04:15Look at the play by Aguilar.
04:17Hello.
04:20After I get through
04:21taking these Voltaren pills,
04:23I think I'll race that guy.
04:25What's the name of him?
04:27Voltaren.
04:28Voltaren?
04:28Yeah, it's been on the market
04:30for 14 years.
04:31There were but in the United States.
04:32It's just been
04:33okayed by the drug of FDA.
04:40Mickey Mantle's here now.
04:41He's in the studio
04:41with Len Berman.
04:42Len.
04:42Thank you, Jack.
04:43It's always a pleasure
04:43to welcome my boyhood hero
04:44back to the station.
04:45What's the, uh,
04:46is this drug a new miracle
04:47drug of sorts?
04:48Well, it's not really new.
04:49It's been around
04:50for like 14 years.
04:51The FDA just approved it,
04:53though, and we had our
04:54press conference today
04:55to announce it.
04:56It helped you?
04:57Stories about Mantle
04:58and Voltaren
04:59were everywhere,
05:00and countless people
05:01called their doctors
05:02asking for the new drug.
05:04At the Today Show,
05:05the switchboard
05:06was swamped with callers
05:07asking how they could
05:08get Voltaren.
05:10But the story took
05:11a different turn
05:11a few days later
05:12when NBC medical reporter
05:14Dr. Art Uline
05:16made the following
05:17very unusual clarification.
05:19Before closing,
05:20I'd like to comment
05:20on a report that appeared
05:21on this program Friday.
05:23That report,
05:24which featured Mickey Mantle,
05:25left many viewers
05:26believing that a new
05:27miracle drug for arthritis
05:29had just been released.
05:30The truth is,
05:31that drug called Voltaren
05:33is neither new
05:34nor miraculous.
05:37Uline said Voltaren
05:38was no more effective
05:39than any other arthritis
05:41drug on the market.
05:43And he also gave his audience
05:44some important information
05:45that Mantle hadn't mentioned.
05:48Mr. Mantle's improvement
05:49with Voltaren
05:49is hardly a miracle.
05:51This was the first time
05:52he was treated
05:53with any drug
05:53other than aspirin.
05:55So his enthusiasm
05:56for Voltaren
05:57is understandable,
05:58especially since he is
05:59a paid spokesperson
06:00for the company
06:01that manufactures the drug.
06:03I just wanted you to know
06:04that the release of Voltaren
06:05is not as dramatic
06:07a breakthrough
06:07as it appeared on Friday.
06:09So all the good news
06:10about Mantle and Voltaren
06:12had been a promotional scheme.
06:15Celebrity endorsements
06:16are common
06:16for over-the-counter drugs,
06:18but very rare
06:19for prescription drugs.
06:21At the FDA,
06:23the Food and Drug Administration,
06:24which regulates drugs
06:25and drug advertising,
06:27officials say
06:28they've seen
06:28a sharp increase
06:29in competition
06:30among drug companies
06:31in the last few years.
06:33Part of the reason
06:34for that
06:35is the FDA itself.
06:37To get a new drug
06:38on the market
06:38in this country
06:39is a long,
06:40slow,
06:41expensive process,
06:42as the companies
06:43find out
06:44when they submit
06:44a new drug
06:45for approval.
06:46Wait a minute.
06:47Let me show you
06:48how that's got to go together.
06:49Just the front page?
06:53Yeah, I know.
06:54But this one goes
06:55with that
06:55and this front page
06:57goes with
06:57what's underneath
06:58that cover.
06:59Because it's
07:00two separate submissions.
07:01Okay.
07:01Okay.
07:02Bless you.
07:03Okay.
07:04Every day,
07:04drug company representatives
07:06drop off pages
07:07of required paperwork.
07:09The documents
07:09on these shelves
07:10are only part
07:11of a single
07:12new drug application.
07:13The review process
07:18is not computerized.
07:20Reviewers go through
07:21each and every page
07:22by hand.
07:24It takes an average
07:25of ten years
07:26for a new drug
07:27to get approved
07:27for sale.
07:33Christmas presents.
07:35The industry says
07:36it costs
07:37$125 million
07:39to bring
07:40a single drug
07:40to market.
07:42Gerald Mossinghoff
07:43is president
07:44of the Pharmaceutical
07:45Manufacturers Association,
07:47a lobbying group
07:47for the industry.
07:49Our industry
07:50produces
07:50the enchanted substances
07:51that give
07:52healthcare professionals
07:53their real power
07:54to cure.
07:55And actually,
07:56prior to World War II,
07:59there really weren't
07:59too many things
08:00that would help.
08:00Doctors could tell you
08:01to stay in bed,
08:02keep warm,
08:03drink a lot of fluids,
08:04and they can make you
08:04feel better.
08:05But because of
08:07the investments
08:08in research and development
08:09that our companies
08:09have made,
08:10we really are making
08:11many diseases obsolete.
08:12It is true
08:18that major strides
08:19have been made
08:20in the last 40 years,
08:21but breakthrough drugs
08:23are still very rare.
08:25Of the 20 or 30 drugs
08:26approved each year,
08:28only three or four
08:29are classified
08:30by the FDA
08:31as significant advances.
08:33The vast majority
08:35of prescription drugs
08:36on the market
08:36are called
08:37Me Too drugs,
08:39similar compounds
08:40which treat the same
08:41disease with minor
08:43chemical differences.
08:48Nine dollars and 16 cents,
08:50Mr. Presley.
08:52Here you go.
08:53Here's your pen.
08:54After 10 years
08:55and over 100 million dollars
08:57in development,
08:58there's enormous pressure
08:59on drug companies
09:00to recoup their investments.
09:01So competition
09:03is intense,
09:04especially with Me Too drugs
09:06for long-term
09:07incurable problems
09:08like allergies,
09:10high blood pressure
09:11and arthritis.
09:15They're all very similar.
09:18They differ
09:18mainly because
09:20one is made by one company
09:22and one is made by another
09:24and each company
09:25is trying to sell
09:26their product
09:28and trying to make
09:30the most
09:30out of what
09:31are in fact
09:32very small differences.
09:34They normally
09:35try to find
09:36some
09:37handle
09:39to make their product
09:40different
09:41than everybody else's.
09:43The handle
09:44Seba Geige
09:45decided to use
09:46for their Me Too drug
09:47Voltaren
09:48was Mickey Mantle.
09:50It was a strategy
09:51designed to get
09:51the name of their drug
09:52out to the public
09:53but it was also
09:54a way for the company
09:55to bypass
09:56federal laws
09:57on prescription
09:58drug advertising.
10:00The FDA
10:00has to approve
10:02any ad
10:02which mentions
10:03a prescription drug
10:04by name
10:05and the government
10:06requires a long list
10:07of side effects
10:08and other dangers
10:09to be included
10:10in the ad.
10:13But when Seba Geige
10:15hires Mickey Mantle
10:16to do interviews
10:16about his success
10:17with Voltaren
10:18he doesn't have
10:19to mention side effects
10:20so Seba
10:21can get only
10:22the positive side
10:23out
10:23using his testimonial.
10:26Perfect.
10:28We think
10:28it's a way
10:29of getting around
10:30our regulation
10:31to some extent.
10:32An attempt
10:33to get around
10:33our regulation
10:34anyway.
10:36It's just
10:37a rather cutthroat
10:38world out there
10:39right now
10:39for the pharmaceutical
10:40industry.
10:41New Orleans
10:50October 1988
10:524,500 doctors
10:54are in town
10:54for a convention.
11:00It's the annual
11:01meeting of the
11:02American Academy
11:02of Family Physicians
11:04a group of
11:0560,000 doctors
11:06nationwide
11:07who prescribe
11:07all sorts of drugs.
11:09It's a perfect
11:10opportunity
11:11for the drug
11:11industry
11:12to sell its wares.
11:13All the major
11:14companies are here
11:15competing to get
11:17doctors to remember
11:18their products.
11:21The exhibits
11:22fill a huge hall
11:23row after row
11:25of elaborate booths
11:27and everywhere
11:28company salesmen
11:29on duty
11:30to pitch
11:30their drugs.
11:32Thanks, Doc.
11:33I appreciate
11:33this very much.
11:37This scene
11:38is repeated
11:38hundreds of times
11:39a year
11:39at the meetings
11:40of all the
11:41major medical
11:41associations.
11:43It's traditional
11:44drug marketing
11:45directed at doctors
11:46who prescribe
11:47the drugs.
11:49But there are
11:50also some new
11:51more aggressive
11:52tactics on display
11:53like this book
11:55for a drug
11:56from Merrill Dow
11:57for hay fever
11:57called Seldane.
12:00Seldane is
12:00for seasonal
12:01allergic rhinitis.
12:03And the beautiful
12:03part about this drug
12:05is that it's
12:06non-sedating.
12:07And many patients
12:08over the past
12:08have had to take
12:09drugs and sedated
12:10them.
12:11And it was
12:11very uncomfortable
12:12for them.
12:13And Seldane
12:14has been a dream
12:15come true
12:16for these people.
12:18Like Sibagagy
12:19with Voltaren,
12:20Merrill Dow
12:20has decided
12:21to sell their drug
12:22directly to patients.
12:24On a monitor
12:25nearby
12:25is their current
12:26campaign of TV
12:27commercials.
12:28Now you can put
12:29your hay fever
12:30to sleep
12:31while you stay
12:31awake.
12:32See your doctor.
12:33Merrill Dow
12:34Pharmaceuticals.
12:35The commercials
12:36don't mention
12:37Seldane by name
12:38because if they did,
12:39Merrill Dow
12:40would have to
12:41include all the
12:41information about
12:42the drug's
12:43side effects.
12:44But the ads
12:44do encourage
12:45people to go
12:46to their doctor
12:47and ask for
12:47that new hay fever
12:49drug that won't
12:49make them drowsy.
12:51These commercials
12:51have helped
12:52Seldane's sales
12:53reach almost
12:54$180 million
12:55a year.
12:57The beautiful thing
12:57is we have
12:58the market
12:58pretty much
12:59sold out.
12:59And for the people
13:00that do have
13:00things coming
13:01over the horizon,
13:02ours is pretty
13:03much entrenched
13:04and we're
13:04really excited
13:05about it.
13:06A drug like this
13:07will come along.
13:08I've been with the
13:08company now 20 years.
13:09It's once in a lifetime.
13:10Every drug company
13:20wants that once
13:21in a lifetime
13:22drug.
13:24In 1982,
13:25the Eli Lilly
13:26company thought
13:26it had one
13:27for arthritis
13:28called
13:29Oriflex.
13:31Lilly had
13:32invested 15 years
13:33and over
13:34$100 million
13:35in Oriflex,
13:37which was being
13:37successfully sold
13:38in Europe
13:39and was eagerly
13:40received in the
13:41U.S.
13:42That was because,
13:43according to Lilly,
13:44Oriflex could do
13:45something no other
13:46drug could.
13:48At a press conference
13:49to announce the
13:50new drug,
13:50Lilly suggested
13:51it might actually
13:53stop arthritis,
13:54not just treat
13:55the symptoms.
13:57It inhibits
13:58certain inflammatory
13:59cells that are
14:01associated with
14:02the process
14:03of arthritis.
14:06Lilly's claim
14:07was big news.
14:08Medical news now,
14:09a breakthrough
14:10in the treatment
14:11of arthritis,
14:11this nation's
14:12number one
14:12crippling disease
14:13affecting some
14:1431 million
14:15Americans.
14:16Lilly claimed
14:17studies in lab
14:18animals showed
14:19Oriflex was a
14:20miracle breakthrough.
14:22That sounded
14:22like a dream
14:23come true to
14:24people with
14:24arthritis,
14:25and Oriflex
14:26was an instant
14:27success.
14:29One woman
14:30who was given
14:30the new drug
14:31was Lola Jones
14:32of Waverly Hall,
14:33Georgia.
14:35Mrs. Jones
14:35was 81.
14:37She lived
14:37in a nursing
14:38home,
14:38but was in
14:39generally good
14:39health,
14:40except for
14:41arthritis.
14:42But only a few
14:43days after
14:43starting Oriflex,
14:44she fell
14:45seriously ill.
14:46Her son,
14:47Clarence
14:48Borum.
14:49She started
14:50swelling,
14:51and water
14:51started coming
14:52out of her
14:53skin,
14:53and she got
14:54to where she
14:55couldn't even
14:57tell the slits
14:58in her eyes,
14:59you know,
14:59just swelled up
15:01so big
15:01it just closed.
15:03Mrs. Jones
15:04was rushed
15:04to this
15:05hospital,
15:06and here
15:06she died
15:07of liver
15:08failure.
15:09It shocked
15:10us.
15:10I mean,
15:11we just
15:11couldn't,
15:11it was all
15:12just on the
15:15spur of the
15:16moment there.
15:16I mean,
15:16it seemed like
15:17there was 30
15:18days' time that
15:19mother was
15:20acting fine
15:21and doing
15:22good,
15:22and then just
15:23went to
15:23nothing.
15:24I mean,
15:24in 30 days,
15:25you know.
15:26The doctors
15:27who treated
15:28Mrs. Jones
15:28had no idea
15:29why she
15:29died.
15:30But a month
15:31or so later,
15:32reports began
15:33to filter
15:33into the
15:34U.S.,
15:35linking
15:35Oroflex
15:36to fatal
15:36liver and
15:37kidney failure
15:38in elderly
15:38patients taking
15:39the drug
15:40in Europe.
15:41Mr. Borum
15:42dug out his
15:43mother's final
15:43bill from
15:44the nursing
15:45home and
15:46discovered she
15:46had taken
15:47Lily's drug.
15:48He contacted
15:49a lawyer.
15:51Ed Kellogg
15:52is a partner
15:52in a law
15:53firm in
15:53Atlanta
15:54specializing
15:55in injury
15:55cases.
15:57When he
15:57started looking
15:58into Mrs. Jones'
15:58death,
15:59he discovered
16:00that all
16:00the good
16:01news about
16:02Oroflex
16:02had been
16:03planned,
16:04paid for,
16:05and orchestrated
16:06by Eli
16:07Lilly.
16:08There was
16:09a blitz
16:11of public
16:11relations
16:12activities
16:13surrounding
16:14the market
16:15introduction
16:15of the drug.
16:16Now,
16:16the market
16:16introduction
16:17of the drug
16:17is called
16:18the launch,
16:19and all
16:20pharmaceutical
16:20companies
16:21launched
16:21their new
16:22drugs
16:22with varying
16:24degrees of
16:24fanfare.
16:25In this
16:26case,
16:26the fanfare
16:27was unprecedented.
16:29Lilly's
16:30promotional
16:30scheme
16:31for
16:31Oroflex
16:32was to
16:32create a
16:33demand
16:33through
16:33the popular
16:34media
16:34to go
16:35directly
16:36to patients.
16:37This was
16:38the first
16:38time a
16:39drug company
16:39broke away
16:40from the
16:40tradition
16:41of marketing
16:41drugs
16:42primarily
16:42to doctors.
16:456,000
16:46press kits
16:46had been
16:47mailed to
16:47newspapers
16:47and magazines
16:48across the
16:49country,
16:50trumpeting
16:50Lilly's
16:51claim that
16:51Oroflex
16:52actually helped
16:53stop arthritis.
16:55Lilly would
16:55not grant
16:56an interview
16:56to Frontline.
16:57The company
16:58had spent
16:5812 million
16:59dollars
16:59promoting
17:00Oroflex
17:00and Kellogg
17:02says all
17:02that money
17:03hit its
17:04target.
17:05Within
17:05six weeks
17:07of the
17:08launch of
17:08Oroflex,
17:09which happened
17:10about May
17:1020,
17:111982,
17:14within six
17:15weeks,
17:15over 500,000
17:16people in the
17:17United States
17:18were taking
17:18that drug
17:19every day.
17:20And the
17:20message that
17:21was aimed
17:21at those
17:22people,
17:23many of
17:24whom had
17:24existed a
17:27miserable
17:27existence for
17:28years on
17:29end with
17:29unremitting
17:30pain and
17:31disability and
17:33increasing
17:33problems from
17:34these terrible
17:35progressive
17:36diseases,
17:37the message
17:38aimed at
17:39those people
17:40is here at
17:41long last,
17:43perhaps,
17:44maybe,
17:46we just
17:47might cure
17:49you.
17:49But the
17:51FDA had
17:52classified
17:53Oroflex as
17:53another
17:54Me Too
17:54drug,
17:55not as
17:56the
17:56breakthrough
17:56Lilly
17:57claimed it
17:57was.
17:59In July
18:001982,
18:01the agency's
18:02advertising
18:02division sent
18:03Lilly a
18:04regulatory
18:04letter objecting
18:06to the
18:06massive PR
18:07campaign.
18:08The letter
18:08said Lilly's
18:09promotion was
18:10false and
18:11misleading,
18:12and that the
18:12company was
18:13minimizing
18:13potentially
18:14serious
18:15side effects.
18:16The FDA
18:16ordered Lilly
18:17to correct
18:18all its
18:18promotional
18:19materials.
18:21But before
18:22Lilly responded
18:22to the
18:23FDA charges,
18:24there was
18:24more bad
18:25news.
18:26Seventy-four
18:27people in
18:27Europe had
18:28died of
18:28liver or
18:29kidney failure
18:30because of
18:30Oroflex.
18:31The British
18:32government pulled
18:33Oroflex off
18:34the market
18:34there, and
18:35one day
18:35later, on
18:36August 4,
18:371982, Lilly
18:39withdrew Oroflex
18:40from sale in
18:41the U.S.
18:43Clarence
18:43Borham was
18:44now convinced
18:45Lilly was
18:45responsible for
18:46his mother's
18:47death, and
18:48he decided to
18:48sue.
18:49He turned
18:50down a
18:50substantial
18:51offer from
18:51Lilly to
18:52settle out
18:53of court.
18:54I wasn't
18:55interested in
18:55the money, I
18:56was interested
18:56in proving to
18:57them and to
18:58the world what
18:59Lilly had
18:59done.
19:00In fact, much
19:01of what is
19:02known about
19:02how Lilly
19:03marketed
19:03Oroflex is
19:04the result of
19:05evidence presented
19:06in the Lola
19:07Jones case.
19:08Kellogg argued
19:09Lilly knew in
19:10advance of the
19:11possibility of
19:12fatal side effects
19:13in elderly
19:13patients, but
19:14withheld that
19:15information from
19:16the FDA when
19:17the agency was
19:18investigating
19:18Oroflex for
19:19approval.
19:21He charged
19:21this was a
19:22deliberate marketing
19:23decision by
19:24Lilly, which was
19:25in a hurry to
19:26get Oroflex on
19:27the market because
19:28of competition
19:29from another
19:30arthritis drug
19:30about to be
19:31launched.
19:32Oroflex was
19:34in a race with
19:35a similar drug
19:36which was about
19:38to be marketed by
19:39the Pfizer
19:39Corporation called
19:40Feldeen.
19:41Indeed, we
19:42were able to
19:43prove and
19:43satisfy the
19:44jury that
19:45Eli Lilly
19:46officials, some
19:48of them pretty
19:48high up in the
19:49hierarchy, had
19:51advanced knowledge
19:52and details of
19:54these strikingly
19:56similar death
19:57cases among
19:58elderly patients
19:59in Europe and
20:01that that
20:01information was
20:03suppressed by
20:05Eli Lilly in
20:06order to
20:08ensure that the
20:10drug received its
20:11marketing approval
20:12from FDA on
20:13time.
20:14The jury in
20:16the Lola Jones
20:16trial was
20:17convinced by
20:18Kellogg's arguments
20:19and awarded
20:20Clarence Borum
20:21six million
20:21dollars for his
20:22mother's death.
20:24Lilly appealed
20:24the verdict, but
20:25Mr. Borum
20:26agreed to a
20:26settlement.
20:28Lola Jones was
20:29one of 49
20:30deaths in the
20:30U.S. due to
20:31Oroflex.
20:33The Justice
20:34Department brought
20:34criminal charges
20:35against Lilly for
20:36withholding
20:37information about
20:38the Oroflex
20:38deaths.
20:39The charges
20:40were eventually
20:41reduced to a
20:41misdemeanor, and
20:43Lilly paid a
20:43$25,000 fine.
20:46As for Lilly's
20:47promotional campaign,
20:48once Oroflex was
20:49withdrawn from the
20:50market, the FDA
20:52completely dropped
20:53its charges.
20:54The agency sent a
20:55letter to Lilly
20:56which said no
20:57useful purpose would
20:58be served by
20:59imposing any
21:00penalties on the
21:01company.
21:02During its 11
21:03weeks on the
21:04American market,
21:05Oroflex grossed
21:06$30 million.
21:06More than the
21:17greatest love the
21:19world has
21:21known, this is the
21:24love I'll give to
21:26you alone.
21:29This is the annual
21:30meeting of the
21:31Arthritis Foundation, a
21:33non-profit educational
21:34group.
21:35Arthritis sufferers in
21:36the U.S.
21:37represent a $1.2
21:38billion a year market
21:40for painkillers.
21:42I've been on
21:43practically every
21:44medication that's out.
21:45I'm one of those rare
21:47individuals that have a
21:48lot of allergic reactions
21:49to medications, so we've
21:50had a lot of trial and
21:51error, but right now I
21:53take 800 milligrams of
21:54Motrin four times a day.
21:56I started out with
21:58Motrin for many years.
22:01Then I switched to
22:02Clineral, and then I
22:05went to Feldeen for a
22:07while and off of
22:08Feldeen, and finally we
22:10arrived at one that was
22:11the easiest or at least
22:13less side effects was
22:14Telectin.
22:16It's an ever-expanding
22:18market.
22:19As the population ages and
22:20more people suffer from
22:21arthritis, the competition
22:23for sales goes on.
22:27Okie dokie.
22:28I'm going to take a
22:29quick look at your arms.
22:31In Fairfax, Virginia,
22:32rheumatologist Paul
22:34Rochmus sees almost
22:354,000 patients with
22:37arthritis each year.
22:40Just yell.
22:40If I get to an area
22:41which is tender or if I
22:43ask you to move
22:43something you don't
22:44want to move, just yell
22:44at me, all right?
22:45Does this hurt your
22:46shoulder?
22:48No.
22:49Dr. Rochmus says
22:51many times the best
22:52drug for arthritis
22:53might be plain old
22:54aspirin, which in
22:56large doses can be
22:57just as powerful as
22:58prescription drugs.
22:59But he also says
23:01many of his patients
23:02aren't satisfied with
23:03aspirin.
23:04They want a
23:04prescription.
23:06When a patient comes
23:07to a specialist such
23:08as a rheumatologist,
23:09he or she, rightfully
23:11or wrongfully, expects
23:12to be treated with
23:14something special.
23:16And my habit
23:18ordinarily is not to
23:20start treating a
23:21disease such as
23:22rheumatoid arthritis
23:23with aspirin because I
23:24think it tends to
23:25inhibit the development
23:27of my therapeutic
23:28relationship with the
23:29patient.
23:30So ordinarily I might
23:32start with a prescription
23:33drug.
23:34Let's talk about the
23:35battle plan first.
23:37We'll just go ahead and
23:38try you on another
23:39anti-inflammatory
23:40medication.
23:41There are about 14 of
23:43these available in the
23:43United States now.
23:45Let's pick naproxen,
23:46just kind of arbitrarily.
23:48And I'm going to start
23:49you on an intermediate
23:50size for a few days
23:51or a week just to be
23:52on the safe side.
23:53And if you have no
23:54trouble taking it,
23:55then you can jump it
23:56up to the full size.
23:58I'll write this down
23:59for you.
24:02Dr. Sidney Wolfe runs
24:03the Public Citizen
24:04Health Research Group,
24:06a watchdog organization
24:07which has studied the
24:08pharmaceutical industry
24:09for 17 years.
24:11Wolfe sees a direct
24:12relationship between
24:14promotion and doctors
24:15writing prescriptions,
24:16especially for Me Too
24:18drugs.
24:19I believe that the
24:20companies are getting
24:21more and more aggressive
24:22as their products are
24:24entering markets that
24:25are already more and
24:26more saturated with
24:27other products that
24:28really aren't any
24:29different.
24:30And so they have to
24:30make an even bigger
24:31pitch to try and get
24:33the attention focused
24:34on their drug.
24:35And we have a number
24:36of examples of drugs
24:37that came on the market
24:38in the last seven or
24:39eight years that took
24:40off to the point where
24:42in a month or two
24:43after they were
24:43introduced, hundreds of
24:45thousands of people
24:45used them.
24:46Unfortunately, a number
24:47of these drugs were so
24:48dangerous that they
24:49had to be taken off
24:50the market.
24:51And because they were
24:52so heavily promoted,
24:53they killed and injured
24:54far more people than
24:55they would have been if
24:56there had been a more
24:57controlled, responsible
24:59kind of promotion of
25:00them.
25:02In 1980, McNeil
25:04Pharmaceuticals, a
25:05division of Johnson &
25:07Johnson, entered the
25:08pain market with a new
25:09drug called Zomax.
25:14In June of that year,
25:15Jody Perez of
25:17Lubbock, Texas, was
25:18hired by McNeil as a
25:19field sales rep, or
25:21detail man.
25:22His main job was to
25:23sell McNeil's new drug,
25:25Zomax.
25:26It was the drug for
25:28McNeil Pharmaceutical.
25:29It was the drug that was
25:30going to be the ultimate
25:32painkiller.
25:36Zomax was a Me Too drug
25:38that the FDA classified as
25:40offering modest therapeutic
25:41gain.
25:47McNeil said Zomax was
25:48strong, fast, and
25:50non-addictive.
25:51These features were the
25:52basis of a promotional
25:54campaign aimed at taking
25:55the pain market away from a
25:57best-selling competitor,
25:58Darvon.
26:00During three months of
26:01sales training, Perez was
26:03taught that Zomax was going
26:04to be a major moneymaker
26:06for McNeil.
26:07In 1981, the total pain
26:09market was $331 million.
26:12Darvon had a third of that,
26:14potentially over $100
26:15million, that Zomax could
26:17capture.
26:19So if you go in and then
26:20aggressively start attacking
26:21that market and taking it,
26:24then eventually the entire
26:26pain market could have or
26:30would have been McNeil's.
26:32As a detail man on a
26:36typical day, Perez would
26:38make sales calls on at
26:39least eight doctors and a
26:41couple of hospitals.
26:42He'd leave samples and
26:43information about McNeil
26:45products.
26:46But the selling didn't end
26:47there.
26:48He had an expense account,
26:50hundreds of dollars a month,
26:51to entertain doctors.
26:53He says this was aimed at
26:54influencing them to
26:55prescribe McNeil drugs.
26:58Once you build up
26:59relationships with certain
27:00physicians, you're able to
27:02go out socially with them,
27:03go out to eat, go out to
27:04certain functions, maybe to
27:07a football game or to a
27:08boxing match, things like
27:10that.
27:11And then they always
27:12remember you.
27:13On more than one occasion,
27:14I could go up to a
27:15physician and say, after
27:17over drinks or over a
27:20meal or whatever, and then
27:21I could just bring it up
27:23real, real casually.
27:25Oh, by the way, could we,
27:27you know, could you start
27:28writing some more, let's say,
27:29Zomax for me or whatever,
27:31in a non-threatening
27:32matter?
27:33It's asking a friend.
27:34I'm not asking a doctor to
27:35do that.
27:36I'm asking a friend to do
27:37me a favor.
27:39And let's say we just
27:40finish eating, you know,
27:42a very expensive steak
27:43dinner and things like
27:45that.
27:46They remember that.
27:47What Jody Perez did with
27:49Zomax is no different than
27:50any other detail man with
27:52any other drug.
27:53The pharmaceutical
27:54companies spend the
27:55majority of their
27:55promotional budgets on
27:57detail men and
27:58entertaining doctors.
27:59The McNeil detail men
28:01got a $1 bonus for each
28:03bottle of Zomax they
28:04sold.
28:05And in one year, they
28:06sold $43 million worth.
28:09At the beginning there, I
28:10mean, we're just very, very
28:10optimistic about it.
28:12And it was selling like
28:13gangbusters.
28:14Everybody wanted it.
28:17But in January 1982,
28:19Perez got some bad news.
28:21Reports in Lubbock of
28:22serious allergic reactions to
28:24McNeil's new drug.
28:25Well, this is where the
28:29adverse reaction report
28:30first was released from
28:32Methodist Hospital here.
28:33One of the individuals who
28:34suffered the most severe
28:35reaction was treated here at
28:36the emergency room.
28:40The person in Lubbock who
28:41had the most severe reaction
28:43to Zomax was himself a
28:44doctor, kidney specialist,
28:47Glenn Stanball.
28:48He passed out after taking
28:49one Zomax pill for pain
28:51from arthritis in his knee.
28:53The next thing I can
28:54remember, I was, I heard
28:57flashing lights and what
29:00sounded like music and it
29:02was very, very realistic.
29:03And I thought, boy, this is
29:05a very vivid dream or I'm in
29:07big trouble.
29:10Stanball was rushed to this
29:11hospital.
29:12His heart had stopped.
29:13He had no blood pressure and
29:15they thought he was dead.
29:16He had suffered a
29:17potentially fatal allergic
29:19reaction called anaphylactic
29:21shock.
29:21Stanball came very close to
29:23dying, but 24 hours of
29:25intensive care saved his
29:27life.
29:28As soon as he was conscious,
29:30Stanball looked in the
29:31Physician's Desk Reference,
29:33or PDR, a book that lists
29:35all possible reactions to
29:37drugs to see if his shock
29:39could have been caused by
29:40Zomax.
29:41Well, I asked for the PDR
29:42immediately as soon as I had
29:45the opportunity to talk, to
29:48look and see what the
29:49insert in the PDR what it
29:51said about allergic reactions
29:53to Zomax.
29:54So I immediately looked at
29:57them.
29:57And what did it say?
29:57It didn't describe anything
29:59like what I had.
30:01Perez had never heard of
30:02anaphylactic shock reactions
30:04to Zomax either, so he
30:06checked his training notes to
30:07see what he was supposed to
30:08tell doctors about side
30:10effects.
30:10Most side effects that the
30:14patient might see would be
30:16nausea, 6 to 12 percent,
30:18short and long term.
30:20Stomach discomfort, 3 to 9
30:22percent.
30:22Dizziness, 3 to 9 percent.
30:24Rash, 3 to 9 percent.
30:27Urinary tract infection, 3 to
30:299 percent.
30:30So see, I mean, you can
30:31basically see this is what it
30:32would boil down to.
30:33And again, this is taken down
30:35word for word.
30:36So you could go in and say,
30:37Doctor?
30:38It's safe as candy.
30:40Perez notified McNeil about
30:45Dr. Stanbaugh's reaction.
30:47But in the next two weeks,
30:48there were three more in
30:49Lubbock, and the major
30:50hospitals there stopped
30:52using the drug.
30:53Sales dropped off almost
30:54completely.
30:55So McNeil sent a company
30:57scientist to Lubbock to
30:58reassure doctors.
31:00She was amazed at the
31:02reaction here in this town.
31:05You know, she said, this is
31:06just like a phenomenon.
31:07You know, we're not seeing
31:08this in other parts of the
31:09country, et cetera, et cetera,
31:10et cetera.
31:11Well, whenever we went back
31:12to her room, to her hotel
31:13room, she would notify, she
31:14started notifying everybody
31:16back at the corporate
31:17headquarters, my immediate
31:19supervisor.
31:20She was talking to the
31:21attorneys with the Johnson
31:23and Johnson.
31:24And the total conversation
31:26was just the complete
31:27opposite with what she was
31:29telling my medical people
31:31here was that, hey, we got
31:32a big time problem out here.
31:34It was at this point here
31:35after seeing her communicate
31:37with the medical community,
31:39but yet going back and tell
31:41another story, that's
31:42whenever I started sensing
31:45that something was wrong.
31:48Something was really, really,
31:50really wrong.
31:53There is no evidence McNeil
31:54knew of the potential for
31:56anaphylactic shock before they
31:57marketed Zomax.
31:59When a drug is tested before
32:01approval, only a couple of
32:02thousand patients take it.
32:04Less common side effects may not
32:06show up in this small sample,
32:08but when Zomax was in wide use
32:10and adverse reactions were
32:12reported, McNeil had to decide
32:14how aggressively to deal with
32:15them.
32:17On April 9, 1982, McNeil sent a
32:20letter to doctors pointing out
32:22the possibility of anaphylactic
32:23reactions to Zomax.
32:25The company also changed the
32:27warnings in each package of
32:29Zomax to include the
32:30possibility of anaphylactic
32:32shock.
32:32But at the time, Zomax faced
32:35direct competition with two
32:37other arthritis drugs,
32:39Oroflex from Lilly and
32:41Feldine from Pfizer.
32:43So one week after the warning
32:44letter went out to doctors,
32:46McNeil embarked on a nationwide
32:48campaign to sell as much
32:50Zomax as possible.
32:52On April 16, 1982, a mailgram was
32:56sent to every McNeil detail man
32:58in America from Tom Odeorn,
33:00vice president of sales.
33:03We're calling it Operation
33:04111.
33:05Now, if that sounds like war,
33:07well, in our world of selling,
33:08that's what it is.
33:10Operation 111 was a massive
33:12sales campaign.
33:14111 represented $111 million,
33:17the sales target McNeil wanted
33:19its detail man to hit.
33:21We would take a tough effort by
33:23a tough sales force in the weeks
33:25ahead, and we're confident that
33:27you're that tough sales force.
33:28Operation 111 begins immediately.
33:32Remember, business belongs to
33:33those who ask for it.
33:35Tom Odeorn, vice president of
33:36sales.
33:38McNeil began sending mock war
33:40bulletins to the detail men,
33:42complete with crossed rifles and
33:44military language.
33:47The company compiled lists of
33:49doctors who were heavy
33:50prescribers of painkillers, and
33:51set a goal for detail men to
33:53call on each doctor three times a
33:55week, each time leaving more
33:57samples of Zomax.
33:59But the one thing the detail men
34:01were told not to do was to draw
34:02attention to possible allergic
34:04reactions.
34:06In February 1982, a company-wide
34:09memo went out with a copy of an
34:10article from the Journal of the
34:11American Medical Association
34:13documenting Zomax's side effects.
34:16The McNeil memo said, quote,
34:18quote, you should not bring up the
34:19subject or use this letter or
34:22article for detailing purposes, end
34:24of quote.
34:26By April, the company was advising
34:27the sales force not to focus on
34:30anaphylactic shock, but permitting
34:32them to discuss it as part of a
34:34balanced presentation.
34:36But in May, Perez received another
34:38memo from his supervisor,
34:40specifically instructing him not to
34:42mention side effects to doctors.
34:43It suggests that you do not spend
34:46selling time initiating discussion
34:50on the Zomax side effects.
34:53We have a lot of other products to
34:54sell, and I feel that you should be
34:55concentrating your efforts on other
34:57items.
34:58But as hard as McNeil tried to
35:00emphasize good news about Zomax,
35:02bad news was starting to come out.
35:06Since first being introduced to the
35:08market just over two years ago,
35:09Zomax has become one of the leading
35:12prescription drugs sold today.
35:15Across the country, anaphylactic shock
35:17reactions, like those in Lubbock, were
35:19being reported.
35:20One doctor in Syracuse, New York, who
35:22took it, passed out while driving and
35:24ran his car off the road.
35:26And there were also reports of
35:28deaths.
35:29This woman, Frances Porto, died two
35:32days after taking Zomax.
35:34Her husband was shocked when nurses
35:36brought him the news.
35:38One on each side of me said,
35:39Mr. Porto, Mrs. Porto died at 3.31 in
35:44the afternoon.
35:45She said, we're so sorry.
35:48I said, but I don't believe this.
35:49She only had bursitis.
35:55McNeil says they reported all adverse
35:57reactions to the FDA.
35:59But what the agency did not know about
36:01was McNeil's memos to the detail men
36:04advising them to downplay the
36:06seriousness of the reactions to
36:07doctors.
36:08Officials here say what a company
36:10chooses to tell its detail men is
36:12beyond the FDA's control.
36:15Absent a whistleblower in the company
36:19or a fly on the wall, it's not
36:22clear to me how we could have access
36:28information about selling techniques.
36:32We simply don't have the authority to go in and get that under most circumstances.
36:41Back in Lubbock,
36:44the husband of a close friend of Perez's had a severe reaction to Zomax.
36:49In July 1982,
36:51one year after he started selling Zomax,
36:53Perez quit.
36:55McNeil offered him a raise
36:56and to move him to another territory.
36:59But he refused.
37:00And I knew that I could have basically
37:03ridden my own ticket with him.
37:06But I just,
37:07you know, whenever people talk of war and the damage that what war does,
37:14well, in this instance here, I saw what war did.
37:17And it wasn't purdy.
37:20And talking to people whose lives were destroyed,
37:22completely destroyed.
37:25And I keep going back to it.
37:26It's $111 million worth of that.
37:31McNeil Pharmaceuticals sold $100 million worth of Zomax
37:34before it withdrew the drug from the market in March 1983.
37:39The company would not grant an on-camera interview to Frontline.
37:42But in a letter,
37:43they said they had, quote,
37:45acted responsibly and in the public interest,
37:48end quote,
37:49in their handling of Zomax.
37:51They also say 15 million people used the drug safely.
37:56The FDA estimates Zomax contributed to 14 deaths
37:59and over 400 life-threatening allergic reactions
38:02in its two and a half years on the market.
38:08The FDA has a range of actions it can take
38:12to regulate drug promotion,
38:13from letters to fines to criminal prosecutions.
38:17Some are made public and are considered more serious,
38:20and others are handled privately
38:22between the agency and the company in question.
38:25In recent years,
38:26the FDA's enforcement statistics
38:28show a sharp drop in serious regulatory actions
38:31against drug companies.
38:33In the years 1971 to 75,
38:36there were an average of 60 serious citations
38:39each year for promotional violations.
38:41In the period 1976 to 1987,
38:45there were fewer than five serious citations each year.
38:50I think what you have seen
38:52is a shift to a less confrontational approach,
38:57a shift to an approach that says,
39:00let's try to prevent problems
39:02before they need the kinds of remedial action
39:07that you've seen at times in the past.
39:12And I think that some of the decline
39:14in very visible regulatory actions
39:18that you may be seeing
39:23may in fact reflect some success
39:26on the part of that strategy.
39:28We've had a very lethal, dangerous partnership
39:32between the drug companies and the FDA,
39:35wherein in instance after instance,
39:37the FDA has not used its authority
39:39to enforce the drug safety laws,
39:41to send letters chastising the companies,
39:45to invoke criminal processes against companies
39:48for false and misleading,
39:50dangerous false and misleading advertising.
39:52The non-confrontational strategy
39:54on the part of the FDA
39:55with respect to the industry
39:56is very good for the industry,
39:58but it is dangerous,
39:59possibly life-taking
40:01for the American public.
40:03Apart from the government,
40:05who is protecting patients
40:06against misleading promotion?
40:08Traditionally, doctors have been
40:10the intermediaries between the companies
40:12and people who actually take the pills.
40:17Dr. Sanford Roth
40:19is an arthritis specialist
40:20in Phoenix, Arizona.
40:22One of his patients
40:23is Lowell Clements,
40:24who has suffered
40:25with a degenerative form of arthritis
40:27since he was nine years old.
40:29The powerful drugs
40:30Mr. Clements takes
40:32to control his pain
40:33make him bleed easily.
40:35His arms are covered with bruises.
40:37I think I've tried everything
40:39on the market.
40:40Everything on the market.
40:41Every new medication
40:43that had come out
40:44since I've had the affliction,
40:48since I was nine years old,
40:49I think I've tried everything
40:50on the market.
40:51Now, let me ask you,
40:53just bend forward comfortably,
40:55don't force yourself
40:56as far as you can.
40:58Lowell Clements' arthritis
40:59has progressed so far
41:01that he can only bend his body
41:02a few inches
41:03in any direction.
41:04Now, let's try and rotate
41:06to the left side
41:08without moving the knees
41:09and to the right side.
41:11Okay.
41:11Now, can you bend back
41:12towards me a little?
41:13That's it.
41:14Right.
41:14But now, Dr. Roth
41:16has told him
41:17there may be hope
41:18with Mickey Mantle's
41:19new drug, Voltaren.
41:21We were waiting
41:22until the new drug,
41:23Voltaren, came.
41:25Yes.
41:25So, immediately,
41:28as soon as they were able
41:31to obtain it,
41:32they put me on it.
41:33Nice to hear it.
41:34Stay out of the trouble.
41:37Voltaren has a good
41:38safety record,
41:39and for now,
41:40Clements says
41:40it's helping him.
41:41But when he got the drug
41:43from Dr. Roth,
41:44what he probably didn't know
41:45was that Roth played
41:46a significant role
41:47in promoting it.
41:51From NBC News,
41:53this is Today.
41:55Sitting next to Mantle
41:56on the Today Show
41:57was Dr. Roth,
41:58and he, too,
41:59said wonderful things
42:00about Voltaren.
42:02The most used drug
42:03in the world today
42:04outside the United States.
42:05We always hear
42:05we're in the back of the line,
42:06but now we're coming up front.
42:08And the nice thing
42:08about this drug,
42:09there aren't any surprises.
42:10We know just about
42:11everything we need
42:12to know about it
42:13and make it as an example
42:14of what it can do
42:15when people need
42:16that kind of help.
42:18But Roth wasn't here
42:19simply as an independent expert.
42:21He was paid by Siba Gagi
42:23to promote Voltaren.
42:25Using doctors
42:26to endorse specific drugs
42:28is another promotional tactic
42:29for some drug companies.
42:32This is how it works.
42:33A doctor like Roth
42:35is hired by a company
42:36which wants a study done,
42:37perhaps comparing its drug
42:39to a competitor.
42:40The company pays Roth a fee,
42:43provides sample pills,
42:44and pays for any tests
42:45patients might need.
42:47At any one time,
42:49Roth has about a dozen
42:50of these studies going on,
42:52involving about 300
42:53of his patients.
42:55What I've tried to do
42:56as carefully as possible
42:57is to be involved
42:59with as many different kinds
43:01of issues
43:02and people as possible.
43:04Therefore,
43:04I don't know
43:05if it's been a half dozen
43:07or more companies
43:08at one time or another
43:09that I've been a consultant to,
43:10giving them advice
43:11on programs and education
43:12and research.
43:14There almost isn't
43:15a company in the United States
43:16that I haven't done research
43:17for at one time or another.
43:20Exactly what Roth gets paid
43:22for this research
43:23is confidential,
43:24but the income
43:25is a significant part
43:26of his practice.
43:28He also profits
43:29when the companies
43:29use his research
43:30for promotional purposes,
43:32paying Roth to give speeches
43:33to other doctors,
43:35endorsing the same drugs
43:36he's been paid to study.
43:38November 1988,
43:40Roth is a featured speaker
43:41at a medical conference
43:43in San Francisco.
43:44Hi, Dr. Roth.
43:46Looking right.
43:48Riker Labs,
43:49a division of 3M,
43:51has paid Roth
43:51to come speak here.
43:54Ladies and gentlemen,
43:55fellow colleagues,
43:55I'm very pleased
43:56to be here.
43:58Roth has a standard speech
43:59on possible side effects
44:00of arthritis drugs,
44:01and this time
44:02he added a section
44:03about an arthritis drug
44:05from his sponsor, 3M.
44:07This is a drug
44:08that was introduced
44:08in 1924 South Slate.
44:11Roth concluded
44:12that 3M's drug
44:13was safer
44:13than the competition.
44:18And in 1982,
44:20Roth plugged
44:20yet another drug
44:21for Eli Lilly.
44:23Roth was a paid consultant
44:25during the launch
44:26of Oriflex.
44:28He authored favorable articles
44:30in two different
44:30medical journals,
44:31concluding that Oriflex
44:33was safer
44:33and more effective
44:34than competing drugs.
44:36One of the articles
44:37was ghostwritten
44:38by a Lilly employee.
44:40And he was listed
44:41in the Lilly press kit
44:43as a doctor
44:43happy to do interviews
44:45about Oriflex.
44:47I think that the work
44:48that I did
44:49with Oriflex
44:50was good,
44:51incredible work,
44:52and I think that
44:52the drug itself
44:53was a useful drug,
44:54but unfortunately,
44:56the problems
44:56with how it was handled
44:58were tragic.
45:00But Roth is proud
45:03of his promotional work
45:04for drug companies
45:05and views his relationship
45:06to them as ethical.
45:08He says doctors
45:09need the information
45:10and that the free
45:12and open marketplace
45:13serves patients well.
45:15There will always be
45:16in our society
45:17a chance
45:17for all those
45:19many competitor sponsors
45:20to get out information
45:21in the other direction.
45:23And I've been really proud
45:24to be considered
45:24an educator
45:25and being very active
45:26in various ways
45:28in my writing
45:29and my speaking programs
45:31and my university program
45:32and in all of those programs.
45:34We've received supports
45:35at different times
45:36in different ways.
45:37And I think that
45:38our society
45:39is appropriately structured
45:41to allow this
45:42to continue
45:43in what will ultimately
45:44be for the good
45:45of the health delivery system.
45:46The medical profession,
45:48unlike sports figures,
45:50have a code of ethics
45:51with respect
45:52to the public health.
45:52Sports figures
45:53are not supposed
45:54to lie, cheat, steal,
45:55whatever else.
45:56But normally
45:57I don't think
45:57that they are
45:58under a Hippocratic oath
46:00that has to do
46:00with protecting their patients
46:01and the public at large.
46:03So what we're really
46:04talking about
46:04is the ethics
46:05of a physician
46:06who knowing
46:06if they really
46:07took a good look
46:08that the drug
46:09isn't really any better
46:09or different
46:10than another drug
46:11still gets paid
46:12to tell the public
46:13and use his or her prestige
46:15to push the drug.
46:16I think this is
46:16a very questionable practice
46:19which I would call unethical.
46:22Roth is one example
46:24of a doctor
46:24with close ties
46:25to the drug industry.
46:27But all American doctors
46:28are targets
46:29of promotional schemes
46:30aimed at influencing
46:32what drugs
46:32they give their patients.
46:34It starts in medical school.
46:36Companies give students
46:37free stethoscopes
46:38and medical bags.
46:41Then when they go
46:41into practice
46:42there are numerous offers
46:43of what the companies
46:44call hospitality.
46:45Some examples.
46:49Smith, Klein and French
46:51held a conference
46:51in San Francisco
46:52about a new antibiotic.
46:54Doctors were paid
46:55all their expenses
46:56plus $500 to attend.
46:59The G.D. Searle Company
47:00sponsored a meeting
47:01on a high blood pressure drug
47:03in Los Angeles
47:03complete with tickets
47:05to the Super Bowl.
47:07And Airst Labs
47:08organized a frequent flyer program
47:11where doctors
47:12who prescribed
47:13Airst's high blood pressure drug
47:14to 50 patients
47:15got a free plane ticket
47:17anywhere in the U.S.
47:23In preparing this report
47:25Frontline contacted
47:26many doctors
47:27who are critical
47:27of these practices
47:28and some agreed
47:30to speak on camera
47:31about their concerns.
47:33But most of them
47:34changed their minds
47:35before filming interviews.
47:37Many said
47:38they were afraid
47:38to publicly criticize
47:40the drug companies.
47:42If you add up
47:43the whining
47:44the dining
47:45the junketing
47:46the research money
47:48the $1,000
47:50for giving a speech
47:51and so forth
47:52you start including
47:53a large majority
47:55of all physicians
47:56in this country.
47:57And therefore
47:57we have a massive example
47:59of silence going on
48:01on the part
48:01of American medicine.
48:02Everyone knows
48:03these things are going on.
48:04No one would deny them
48:05because to deny them
48:07would be to lie.
48:07And yet
48:08to speak out critically
48:09which we would think
48:11would be an ethical
48:11responsibility of physicians
48:12just doesn't seem
48:14to happen very often.
48:16Frontline also tried
48:17to talk to people
48:18inside the industry
48:19about promotion
48:20and marketing.
48:21Fourteen of the largest
48:23pharmaceutical companies
48:24were asked
48:24for on-camera interviews.
48:26All refused.
48:28And when the
48:29Pharmaceutical Manufacturers
48:30Association
48:31agreed to this interview
48:32they set strict limitations
48:34on what could be covered.
48:36One subject
48:36that was off-limits
48:38they said
48:38was any specific
48:39marketing
48:40or promotional practices.
48:42Well the Pharmaceutical
48:43Manufacturers Association
48:44is an association
48:45of more than
48:46100 competitors
48:47in the research-based
48:49pharmaceutical industry.
48:51And as an association
48:52of competitors
48:52we do not involve
48:54ourselves
48:55and the board of directors
48:55does not involve itself
48:56in any decisions
48:58having to do with pricing
48:59or marketing
49:01or promotion
49:02or medical sales
49:04representatives.
49:05And because of that
49:06our council
49:06or antitrust council
49:08advised us
49:08to stay far away
49:09from that
49:09and because of that
49:10I agreed with you
49:12in agreeing
49:13to do this interview
49:14that I would not
49:14answer specific questions
49:17about specific
49:17company practices
49:18because we're not
49:19involved in it
49:19and it would just
49:19simply not be
49:20an appropriate question.
49:23One of the specific
49:25practices
49:25the industry
49:26won't discuss
49:27is this
49:27all expenses
49:29paid trips
49:30to vacation spots
49:31called scientific
49:32symposia
49:33by the industry.
49:35November 1988
49:36Seba Geige
49:38invites 150 doctors
49:39and their spouses
49:40to the deluxe
49:42Marco Island Resort
49:43off the coast
49:44of Florida
49:44for a weekend meeting
49:46on issues
49:46related to Voltaren.
49:49The company
49:49paid the entire
49:50cost of the weekend
49:51including airfare,
49:53rooms,
49:54meals,
49:54two receptions
49:55with unlimited cocktails
49:56and a Saturday
49:57evening dinner dance.
49:59I want to
50:00thank Jeff Williams
50:02from Seba Geige
50:03for inviting me here.
50:04On Saturday morning
50:06five doctors
50:07gave speeches
50:08on arthritis treatment.
50:10They were hand-picked
50:10by Seba Geige
50:11and paid an honorarium.
50:13The industry standard
50:14ranges up to
50:15$1,000 per speech.
50:17The company
50:18gave front-line
50:19excerpts
50:20of two of the speeches
50:21recorded by
50:22a company film crew
50:23but would not allow
50:24our own camera
50:25inside.
50:27Only three and a half
50:29hours of the entire
50:30weekend were devoted
50:31to scientific presentations.
50:32The rest of the time
50:33was free.
50:36No one from Seba Geige
50:38would talk to
50:38Frontline on camera.
50:40Off camera
50:41the company says
50:42the purpose of this
50:42meeting is purely
50:43educational.
50:45Dr. Fred McDuffie
50:46former medical director
50:48of the Arthritis Foundation
50:49says it's understood
50:50that all the information
50:52presented will be
50:53favorable to the
50:54company's drug.
50:55I think that
50:56most people
50:57that will accept
50:58an invitation
50:58to come to this
50:59they will not knock
51:00that particular drug.
51:01In other words
51:01if they have something
51:02negative to say
51:03about the drug
51:04they won't be
51:05in their presentation.
51:06Drug companies
51:07have held junkets
51:08like this one
51:09in Paris, Venice,
51:10Hawaii and on
51:11vacation islands.
51:13The American
51:13Medical Association
51:14has no rules
51:15about the ethics
51:16of doctors
51:17accepting free trips
51:18like this one.
51:20I think that
51:21doctors, many of them
51:22are blind
51:23to the conflict
51:24of interest.
51:25Doctors will deny
51:26that this has
51:27any influence
51:28on their prescribing
51:28practice.
51:29The worry
51:30with any kind
51:30of conflict
51:31of interest
51:31on the part
51:32of a physician
51:32is that the
51:33doctors will make
51:34decisions about
51:35prescribing drugs
51:36that will not be
51:37based just on
51:37the best interest
51:38of the patient
51:39but which will be
51:40based on which
51:41company has been
51:42nicest to them.
51:43I think it's kind
51:44of demeaning
51:45to think that
51:45doctors who are
51:47learned professionals
51:48they've had great
51:49educations
51:49they're practicing
51:50doctors
51:50in any way
51:52can be promoted
51:53to do something
51:54that isn't in the
51:55best interest
51:55of their patient.
51:56I refuse to believe
51:58that.
51:59Most of the doctors
52:00attending the conference
52:01wouldn't talk
52:02to Frontline.
52:03In fact,
52:04Siba Geige
52:04made an announcement
52:05encouraging doctors
52:06to refuse interviews
52:07with reporter
52:08Joe Rosenblum.
52:13But the two doctors
52:14who did talk
52:15insisted this weekend
52:16will not influence
52:17them to prescribe
52:18more Voltaren.
52:20I don't believe
52:21anybody would prescribe
52:22a drug more
52:22because they came
52:23to a meeting
52:23put on by Siba
52:26and I don't think
52:27so.
52:27I think it's
52:28a tradition
52:28in the industry
52:29that entertainment
52:30is a big thing
52:31in the pharmaceutical
52:31industry.
52:32It's become a sort
52:33of way of life
52:34kind of thing.
52:36In other words,
52:37there's so many
52:37conferences like this
52:39that they don't
52:40stand out.
52:41They're not all
52:42that unusual.
52:45Frontline estimates
52:46this weekend junket
52:47cost Siba Geige
52:48well over $100,000.
52:50researchers are
52:55beginning to study
52:55the overall impact
52:57of drug marketing
52:58and how doctors
52:59are actually
52:59affected by it.
53:02Dr. Jerry Avorn
53:03is a specialist
53:04in internal medicine
53:05at Harvard Medical
53:06School and the
53:07Beth Israel Hospital
53:08in Boston.
53:10Good morning.
53:11Hi.
53:12Avorn recently
53:13published a study
53:14of how doctors
53:15decide what drugs
53:16to give their patients.
53:18He says he found
53:19that a lot of doctors
53:20rely heavily
53:20on promotional materials
53:22given to them
53:23by the drug companies.
53:25We found that
53:25in a large proportion
53:27of cases,
53:28what they knew
53:28or thought they knew
53:29about the drugs
53:30could not have possibly
53:31come from the
53:32scientific literature
53:32since the scientific literature
53:34didn't say that
53:35about those drugs.
53:36It must have come
53:36from what they heard
53:37in promotional materials
53:39because these drugs
53:40were being promoted
53:41as quite good,
53:42quite effective,
53:43quite safe,
53:44when all the well-done
53:45scientific studies
53:46show that they were
53:46quite ineffective
53:47and in some cases
53:48dangerous.
53:49Aborn also says
53:52his study points
53:53to a larger problem,
53:54overuse of prescription drugs,
53:56which puts patients
53:57at risk,
53:59both financially
53:59and medically.
54:01There are many,
54:02many patients
54:02whose pain
54:03would be relieved
54:04every bit as well
54:05and as safely
54:05by aspirin
54:06or by acetaminophen
54:08or Tylenol.
54:09So, on the one hand,
54:10it's a cost issue.
54:11The safety issue
54:12is also present,
54:14and that is that
54:15people are perhaps
54:16getting these drugs
54:17when they may not
54:19truly need medication
54:20at all.
54:21When people are taking
54:22large, ongoing doses
54:25of these drugs,
54:26even though their drugs
54:27have a good safety
54:28risk ratio,
54:30there are going to be
54:31people who are going
54:32to be having side effects
54:33who might not have
54:34if we were not,
54:35as a nation,
54:35consuming so many tons
54:37of this stuff a year.
54:37more prescription drugs
54:40are consumed in America
54:41than anywhere else
54:42in the world,
54:43$30 billion worth
54:44each year.
54:46It's a perfect environment
54:47for aggressive marketing
54:48by the pharmaceutical industry.
54:51The American public,
54:52they don't know.
54:53They don't know
54:54how intense this is,
54:57how conniving
54:57and what the company
55:03will do to get
55:04the physicians
55:04to go ahead
55:05and prescribe a drug.
55:10As long as people
55:11have pain
55:11and as long as
55:12there is a need,
55:14you're still going
55:15to have people
55:15that are going to say,
55:16we have to get
55:17the product to them.
55:24Last month,
55:26the U.S. Department
55:26of Health and Human Services
55:28released a major study
55:30which concluded
55:31that faulty prescribing
55:32is a serious problem
55:34for older Americans.
55:35It's been called
55:36America's other drug problem.
55:39According to the report,
55:40one major factor
55:41in the number
55:42of adverse drug reactions
55:44among the elderly
55:45is their doctors'
55:46over-reliance
55:47on promotional materials
55:49provided by
55:50the drug manufacturers.
55:52One final note
55:53about Voltaren.
55:55While its safety record
55:57remains good,
55:58the FDA
55:59has recently
56:00criticized
56:01C. Bageige
56:01for understating
56:03in its promotional materials
56:05the risks
56:06of kidney damage
56:07from Voltaren.
56:09Thank you for joining us.
56:11I'm Judy Woodruff.
56:13Good night.
56:16Behind the gleaming face
56:18of Dallas
56:18lies a war zone.
56:22Police spend
56:22half a billion dollars
56:23a year fighting drugs,
56:25but they're losing the war.
56:26I believe I could do
56:27a better job.
56:29So the black community
56:29at odds with the
56:30mostly white police force
56:31is taking matters
56:32into its own hands.
56:34We're challenging
56:35the pushers
56:35and the drug houses
56:37directly.
56:38The Dallas Drug War,
56:40next time on Frontline.
56:46The End
57:16Frontline is produced for the Documentary Consortium by WGBH Boston, which is solely responsible for its content.
57:25Funding for Frontline is provided by this station and other public television stations nationwide, and by the Corporation for Public Broadcasting.
57:37For videocassette information about this program, please write to this address.
57:46For a transcript of this program, please send $5 to Frontline, Box 322, Boston, Massachusetts, 02134.
58:00The End
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