Funding for Frontline is provided by this station and other public television stations nationwide
and by the Corporation for Public Broadcasting.
Pharmaceutical companies compete fiercely for a lion's share of the prescription drug market.
The American public, they don't know.
They don't know what the company will do to get the physicians to go ahead and prescribe a drug.
Frontline investigates drug marketing methods and how doctors are influenced to prescribe and even promote drugs.
These drugs were being promoted as quite good, quite effective, quite safe,
when all the well-done scientific studies show that they were quite ineffective and in some cases dangerous.
Tonight on Frontline, prescriptions for profit.
From the network of public television stations, a presentation of KCTS Seattle, WNET New York, WPBT Miami, WTVS Detroit, and WGBH Boston,
this is Frontline with Judy Woodruff.
Good evening. Every year, Americans take more and more prescription drugs.
If that's troubling news to some, it's good news for the pharmaceutical industry.
The prescription drug market, now $30 billion a year, is one of the most intensely competitive in the country.
Tonight, Frontline examines that competition and how prescription drugs are marketed to doctors and to patients.
Tonight's program was produced and written by Elizabeth Arledge and reported by Joe Rosenblum.
It is called Prescriptions for Profit.
June 1969. Baseball great Mickey Mantle retires at age 36.
It's been a great honor. I'll never forget it. God bless you all and thank you very much.
Mantle was an American legend, a hero to his fans, but injuries to his knees had forced him to give up the game.
And now so that Mickey's fans can bid him a personal farewell, he'll take one last turn around Yankee Stadium.
In the years since his retirement, Mickey Mantle has become one of the 37 million Americans who suffer from arthritis.
But in the summer of 1988, Mantle announced what sounded like a miracle.
He appeared on NBC's Today Show to endorse a new prescription drug for arthritis called Voltaren.
Well, I didn't even know I had arthritis. Like I said, I thought I was just getting old until Dr. Greenberg told me that.
And of course, when he put me on the program, it was to take Voltaren. So I've been on it about a year.
Mantle said Voltaren had done wonders for the arthritis in his knees.
But now I can play golf almost painless.
It was a good story. A baseball star delivered from pain, courtesy of what appeared to be a new wonder drug.
Seba Geige, the manufacturer of Voltaren, is the world's fourth largest drug company, with annual sales of $11.5 billion.
Voltaren has been on the European market since 1974. It has a good overall safety record.
And Seba says it is the best-selling arthritis drug in the world.
In the U.S., Voltaren has captured $50 million worth of arthritis drug sales in just six months.
That success is due partly to the testimonial of Mickey Mantle, who praised the new drug at every chance.
Sports Channel presents New York Yankees baseball.
Look at this. Look at the play by Aguayo. Hello.
After I get through taking these Voltaren pills, I think I'll race that guy.
What's the name of him?
Voltaren.
Voltaren?
Yeah, it's been on the market for 14 years, everywhere but in the United States. It's just been okayed by the drug FDA.
Mickey Mantle's here now. He's in the studio with Len Berman.
Thank you, Jack. It's always a pleasure to welcome my boyhood hero back to the station.
Is this drug a numerical drug of sorts?
Well, it's not really new. It's been around for like 14 years. The FDA just approved it, though, and we had our press conference today to announce it.
Stories about Mantle and Voltaren were everywhere, and countless people called their doctors asking for the new drug.
At the Today Show, the switchboard was swamped with callers asking how they could get Voltaren.
But the story took a different turn a few days later when NBC medical reporter Dr. Art Uline made the following very unusual clarification.
Before closing, I'd like to comment on a report that appeared on this program Friday.
That report, which featured Mickey Mantle, left many viewers believing that a new miracle drug for arthritis had just been released.
The truth is that drug called Voltaren is neither new nor miraculous.
Uline said Voltaren was no more effective than any other arthritis drug on the market.
And he also gave his audience some important information that Mantle hadn't mentioned.
Mr. Mantle's improvement with Voltaren is hardly a miracle.
This was the first time he was treated with any drug other than aspirin.
So his enthusiasm for Voltaren is understandable, especially since he is a paid spokesperson for the company that manufactures the drug.
I just wanted you to know that the release of Voltaren is not as dramatic a breakthrough as it appeared on Friday.
So all the good news about Mantle and Voltaren had been a promotional scheme.
Celebrity endorsements are common for over-the-counter drugs, but very rare for prescription drugs.
At the FDA, the Food and Drug Administration, which regulates drugs and drug advertising,
officials say they've seen a sharp increase in competition among drug companies in the last few years.
Part of the reason for that is the FDA itself.
To get a new drug on the market in this country is a long, slow, expensive process,
as the companies find out when they submit a new drug for approval.
Wait a minute. Let me show you how that's got to go together.
Just dig at the front page.
Yeah, I know, but this one goes with that, and this front page goes with what's underneath that cover, because it's two separate submissions.
Okay.
Bless you.
Okay.
Every day, drug company representatives drop off pages of required paperwork.
The documents on these shelves are only part of a single new drug application.
The review process is not computerized.
Reviewers go through each and every page by hand.
It takes an average of 10 years for a new drug to get approved for sale.
Christmas presents for you.
The industry says it costs $125 million to bring a single drug to market.
Gerald Mossinghoff is president of the Pharmaceutical Manufacturers Association, a lobbying group for the industry.
Our industry produces the enchanted substances that give health care professionals their real power to cure.
And actually, prior to World War II, there really weren't too many things that would help.
Doctors could tell you to stay in bed, keep warm, drink a lot of fluids, and they can make you feel better.
But because of the investments in research and development that our companies have made, we really are making many diseases obsolete.
It is true that major strides have been made in the last 40 years, but breakthrough drugs are still very rare.
Of the 20 or 30 drugs approved each year, only three or four are classified by the FDA as significant advances.
The vast majority of prescription drugs on the market are called Me2 drugs, similar compounds which treat the same disease with minor chemical differences.
$9.16, Mr. Pressley. Here you go. Here's your pen.
After 10 years and over $100 million in development, there's enormous pressure on drug companies to recoup their investments.
So competition is intense, especially with Me2 drugs for long-term incurable problems like allergies, high blood pressure, and arthritis.
They're all very similar. They differ mainly because one is made by one company and one is made by another.
And each company is trying to sell their product and trying to make the most out of what are, in fact, very small differences.
They normally try to find some handle to make their product different than everybody else's.
The handle Seba Geige decided to use for their Me2 drug Voltaren was Mickey Mantle.
It was a strategy designed to get the name of their drug out to the public, but it was also a way for the company to bypass federal laws on prescription drug advertising.
The FDA has to approve any ad which mentions a prescription drug by name, and the government requires a long list of side effects and other dangers to be included in the ad.
But when Seba Geige hires Mickey Mantle to do interviews about his success with Voltaren, he doesn't have to mention side effects.
So Seba can get only the positive side out using his testimonial.
Perfect. We think it's a way of getting around our regulation to some extent, an attempt to get around our regulation anyway.
It's just a rather cutthroat world out there right now for the pharmaceutical industry.
New Orleans, October 1988.
Forty-five hundred doctors are in town for a convention.
It's the annual meeting of the American Academy of Family Physicians, a group of 60,000 doctors nationwide who prescribe all sorts of drugs.
It's a perfect opportunity for the drug industry to sell its wares.
All the major companies are here competing to get doctors to remember their products.
The exhibits fill a huge hall, row after row of elaborate booths, and everywhere company salesmen on duty to pitch their drugs.
Thanks, Doc. I appreciate this very much.
This scene is repeated hundreds of times a year at the meetings of all the major medical associations.
It's traditional drug marketing directed at doctors who prescribe the drugs.
But there are also some new, more aggressive tactics on display, like this booth for a drug from Merrell Dow for hay fever called Selden.
Selden is for seasonal allergic rhinitis.
And the beautiful part about this drug is that it's non-sedating.
And many patients over the past have had to take drugs that sedated them, and it was very uncomfortable for them.
And Selden has been a dream come true for these people.
Like Siba Gaigi with Voltaren, Merrell Dow has decided to sell their drug directly to patients.
On a monitor nearby is their current campaign of TV commercials.
Now you can put your hay fever to sleep while you stay awake. See your doctor.
Merrell Dow Pharmaceuticals.
The commercials don't mention Selden by name, because if they did, Merrell Dow would have to include all the information about the drug's side effects.
But the ads do encourage people to go to their doctor and ask for that new hay fever drug that won't make them drowsy.
These commercials have helped Selden's sales reach almost $180 million a year.
The beautiful thing is we have the market pretty much sold out.
And for the people that do have things coming over the horizon, ours is pretty much entrenched, and we're really excited about it.
A drug like this will come along. I've been with the company now 20 years. It's once in a lifetime.
Every drug company wants that once-in-a-lifetime drug.
In 1982, the Eli Lilly Company thought it had one for arthritis called Auriflex.
Lilly had invested 15 years and over $100 million in Auriflex,
which was being successfully sold in Europe and was eagerly received in the U.S.
That was because, according to Lilly, Auriflex could do something no other drug could.
At a press conference to announce the new drug, Lilly suggested it might actually stop arthritis, not just treat the symptoms.
It inhibits certain inflammatory cells that are associated with the process of arthritis.
Lilly's claim was big news.
Medical news now, a breakthrough in the treatment of arthritis, this nation's number one crippling disease affecting some 31 million Americans.
Lilly claimed studies in lab animals showed Auriflex was a miracle breakthrough.
That sounded like a dream come true to people with arthritis, and Auriflex was an instant success.
One woman who was given the new drug was Lola Jones of Waverly Hall, Georgia.
Mrs. Jones was 81.
She lived in a nursing home, but was in generally good health except for arthritis.
But only a few days after starting Auriflex, she fell seriously ill.
Her son, Clarence Borum.
She started swelling, and water started coming out of her skin,
and she got to where she couldn't even tell the slits in her eyes, you know, just swelled up so big it just closed.
Mrs. Jones was rushed to this hospital, and here she died of liver failure.
It shocked us. I mean, we just couldn't, it was all just on the spur of the moment there.
I mean, it seemed like there was 30 days time that mother was acting fine and doing good and then just went to nothing.
I mean, in 30 days.
The doctors who treated Mrs. Jones had no idea why she died.
But a month or so later, reports began to filter into the U.S.,
linking Auriflex to fatal liver and kidney failure in elderly patients taking the drug in Europe.
Mr. Borum dug out his mother's final bill from the nursing home and discovered she had taken Lilly's drug.
He contacted a lawyer.
Ed Kellogg is a partner in a law firm in Atlanta specializing in injury cases.
When he started looking into Mrs. Jones's death, he discovered that all the good news about Auriflex had been planned, paid for, and orchestrated by Eli Lilly.
There was a blitz of public relations activities surrounding the market introduction of the drug.
Now, the market introduction of the drug is called the launch,
and all pharmaceutical companies launch their new drugs with varying degrees of fanfare.
In this case, the fanfare was unprecedented.
Lilly's promotional scheme for Auriflex was to create a demand through the popular media to go directly to patients.
This was the first time a drug company broke away from the tradition of marketing drugs primarily to doctors.
6,000 press kits had been mailed to newspapers and magazines across the country, trumpeting Lilly's claim that Auriflex actually helped stop arthritis.
Lilly would not grant an interview to Frontline.
The company had spent $12 million promoting Auriflex, and Kellogg says all that money hit its target.
Within six weeks of the launch of Auriflex, which happened on about May 20, 1982, within six weeks, over 500,000 people in the United States were taking that drug every day.
And the message that was aimed at those people, many of whom had existed, a miserable existence for years on end with unremitting pain and disability and increasing problems from these terrible progressive diseases,
the message aimed at those people is here at long last, perhaps, maybe, we just might cure you.
But the FDA had classified Auriflex as another MeToo drug, not as the breakthrough Lilly claimed it was.
In July 1982, the agency's advertising division sent Lilly a regulatory letter objecting to the massive PR campaign.
The letter said Lilly's promotion was false and misleading and that the company was minimizing potentially serious side effects.
The FDA ordered Lilly to correct all its promotional materials.
But before Lilly responded to the FDA charges, there was more bad news.
Seventy-four people in Europe had died of liver or kidney failure because of Auriflex.
The British government pulled Auriflex off the market there, and one day later, on August 4, 1982, Lilly withdrew Auriflex from sale in the U.S.
Clarence Borum was now convinced Lilly was responsible for his mother's death, and he decided to sue.
He turned down a substantial offer from Lilly to settle out of court.
I wasn't interested in the money. I was interested in proving to them and to the world what Lilly had done.
In fact, much of what is known about how Lilly marketed Auriflex is the result of evidence presented in the Lola Jones case.
Kellogg argued Lilly knew in advance of the possibility of fatal side effects in elderly patients,
but withheld that information from the FDA when the agency was investigating Auriflex for approval.
He charged this was a deliberate marketing decision by Lilly,
which was in a hurry to get Auriflex on the market because of competition from another arthritis drug about to be launched.
Auriflex was in a race with a similar drug, which was about to be marketed by the Pfizer Corporation, called Feldeen.
Indeed, we were able to prove and satisfy the jury that Eli Lilly officials, some of them pretty high up in the hierarchy,
had advanced knowledge and details of these strikingly similar death cases among elderly patients in Europe,
and that that information was suppressed by Eli Lilly in order to ensure that the drug received its marketing approval from FDA on time.
The jury in the Lola Jones trial was convinced by Kellogg's arguments and awarded Clarence Borum $6 million for his mother's death.
Lilly appealed the verdict, but Mr. Borum agreed to a settlement.
Lola Jones was one of 49 deaths in the U.S. due to Auriflex.
The Justice Department brought criminal charges against Lilly for withholding information about the Auriflex deaths.
The charges were eventually reduced to a misdemeanor, and Lilly paid a $25,000 fine.
As for Lilly's promotional campaign, once Auriflex was withdrawn from the market, the FDA completely dropped its charges.
The agency sent a letter to Lilly which said no useful purpose would be served by imposing any penalties on the company.
During its 11 weeks on the American market, Auriflex grossed $30 million.
This is the annual meeting of the Arthritis Foundation, a nonprofit educational group.
Arthritis sufferers in the U.S. represent a $1.2 billion a year market for painkillers.
I've been on practically every medication that's out.
I'm one of those rare individuals that have a lot of allergic reactions to medications, so we've had a lot of trial and error.
But right now I take 800 milligrams of Motrin four times a day.
I started out with Motrin for many years, then I switched to clinical, and then I went to Feldeen for a while and off of Feldeen.
And finally we arrived at one that was the easiest, or at least less side effects, was Tilectin.
It's an ever-expanding market. As the population ages and more people suffer from arthritis, the competition for sales goes on.
Okie dokie. I want to take a quick look at your arms.
In Fairfax, Virginia, rheumatologist Paul Rochmus sees almost 4,000 patients with arthritis each year.
Just yell. If I get to an area which is tender or if I ask you to move something you don't want to move, just yell at me, all right?
Does this hurt your shoulder? No.
Dr. Rochmus says many times the best drug for arthritis might be plain old aspirin, which in large doses can be just as powerful as prescription drugs.
But he also says many of his patients aren't satisfied with aspirin. They want a prescription.
When a patient comes to a specialist such as a rheumatologist, he or she rightfully or wrongfully expects to be treated with something special.
And my habit ordinarily is not to start treating a disease such as rheumatoid arthritis with aspirin,
because I think it tends to inhibit the development of my therapeutic relationship with the patient.
So ordinarily I might start with a prescription drug.
Let's talk about the battle plan first. We'll just go ahead and try you on another anti-inflammatory medication.
There are about 14 of these available in the United States now.
Let's pick Naprosyn, just kind of arbitrarily.
And I'm going to start you on an intermediate size for a few days or a week just to be on the safe side.
And if you have no trouble taking it, then you can jump it up to the full size. I'll write this down for you.
Dr. Sidney Wolf runs the Public Citizen Health Research Group,
a watchdog organization which has studied the pharmaceutical industry for 17 years.
Wolf sees a direct relationship between promotion and doctors writing prescriptions, especially for Me2 drugs.
I believe that the companies are getting more and more aggressive as their products are entering markets
that are already more and more saturated with other products that really aren't any different.
And so they have to make an even bigger pitch to try and get the attention focused on their drug.
And we have a number of examples of drugs that came on the market in the last seven or eight years
that took off to the point where in a month or two after they were introduced, hundreds of thousands of people used them.
Unfortunately, a number of these drugs were so dangerous that they had to be taken off the market.
And because they were so heavily promoted, they killed and injured far more people than they would have been
if there had been a more controlled, responsible kind of promotion of them.
In 1980, McNeill Pharmaceuticals, a division of Johnson & Johnson, entered the pain market with a new drug called Zomax.
In June of that year, Jody Perez of Lubbock, Texas, was hired by McNeill as a field sales rep or detail man.
His main job was to sell McNeill's new drug, Zomax.
It was the drug for McNeill Pharmaceutical. It was the drug that was going to be the ultimate painkiller.
Zomax was a Me2 drug that the FDA classified as offering modest therapeutic gain.
McNeill said Zomax was strong, fast, and non-addictive.
These features were the basis of a promotional campaign aimed at taking the pain market away from a best-selling competitor, Darvon.
During three months of sales training, Perez was taught that Zomax was going to be a major moneymaker for McNeill.
In 1981, the total pain market was $331 million. Darvon had a third of that, potentially over $100 million that Zomax could capture.
So if you go in and then aggressively start attacking that market and taking it, then eventually the entire pain market could have or would have been McNeill's.
As a detail man on a typical day, Perez would make sales calls on at least eight doctors and a couple of hospitals.
He'd leave samples and information about McNeill products.
But the selling didn't end there. He had an expense account, hundreds of dollars a month, to entertain doctors.
He says this was aimed at influencing them to prescribe McNeill drugs.
Once you build up relationships with certain physicians, you're able to go out socially with them, go out to eat, go out to certain functions,
maybe to a football game or to a boxing match, things like that. And then they always remember you.
On more than one occasion, I could go up to a physician and say, after over drinks or over a meal or whatever, and then I could just bring it up real, real casually.
Oh, by the way, could we, you know, could you start writing some more, let's say, Zomax for me or whatever in a non-threatening manner?
It's asking a friend. I'm not asking a doctor to do it. I'm asking a friend to do me a favor.
And let's say we just finished eating, you know, a very expensive steak dinner and things like that. They remember that.
What Jody Perez did with Zomax is no different than any other detail man with any other drug.
The pharmaceutical companies spend the majority of their promotional budgets on detail men and entertaining doctors.
The McNeil detail men got a $1 bonus for each bottle of Zomax they sold, and in one year they sold $43 million worth.
At the beginning there, I mean, we were just very, very optimistic about it. And it was selling like gangbusters. Everybody wanted it.
But in January 1982, Perez got some bad news, reports in Lubbock of serious allergic reactions to McNeil's new drug.
Well, this is where the adverse reaction report first was released from the Methodist Hospital here.
One of the individuals who suffered the most severe reaction was treated here at the emergency room.
The person in Lubbock who had the most severe reaction to Zomax was himself a doctor, kidney specialist Glenn Stanball.
He passed out after taking one Zomax pill for pain from arthritis in his knee.
Next thing I can remember, I heard flashing lights and what sounded like music, and it was very, very realistic.
And I thought, boy, this is a very vivid dream or I'm in big trouble.
Stanball was rushed to this hospital. His heart had stopped. He had no blood pressure, and they thought he was dead.
He had suffered a potentially fatal allergic reaction called anaphylactic shock.
Stanball came very close to dying, but 24 hours of intensive care saved his life.
As soon as he was conscious, Stanball looked in the Physician's Desk Reference or PDR,
a book that lists all possible reactions to drugs to see if his shock could have been caused by Zomax.
Well, I asked for the PDR immediately as soon as I had the opportunity to talk,
to look and see what the insert in the PDR or what it said about allergic reactions to Zomax.
So I immediately looked at it.
And what did it say?
It didn't describe anything like what I'd had.
Perez had never heard of anaphylactic shock reactions to Zomax either,
so he checked his training notes to see what he was supposed to tell doctors about side effects.
Most side effects that the patient might see would be nausea, 6 to 12 percent, short and long term,
stomach discomfort, 3 to 9 percent, dizziness, 3 to 9 percent, rash, 3 to 9 percent,
urinary tract infection, 3 to 9 percent.
So you can basically see this is what it would boil down to.
And again, this is taken down word for word.
So you could go in and say, doctor?
It's safe as candy.
Perez notified McNeil about Dr. Stanbaugh's reaction.
But in the next two weeks, there were three more in Lubbock,
and the major hospitals there stopped using the drug.
Sales dropped off almost completely.
So McNeil sent a company scientist to Lubbock to reassure doctors.
She was amazed at the reaction here in this town.
She said, this is just like a phenomenon.
We're not seeing this in other parts of the country, et cetera, et cetera, et cetera.
Well, whenever we went back to her room, to her hotel room, she would notify.
She started notifying everybody back at the corporate headquarters.
My immediate supervisor, she was talking to the attorneys with the Johnson & Johnson.
And the total conversation was just the complete opposite with what she was telling my medical people here,
was that, hey, we've got a big time problem out here.
It was at this point here after seeing her communicate with the medical community,
but she had gone back and told another story.
That's whenever I started sensing that something was wrong.
Something was really, really, really wrong.
There is no evidence McNeil knew of the potential for anaphylactic shock before they marketed Zomax.
When a drug is tested before approval, only a couple of thousand patients take it.
Less common side effects may not show up in this small sample.
But when Zomax was in wide use and adverse reactions were reported,
McNeil had to decide how aggressively to deal with them.
On April 9, 1982, McNeil sent a letter to doctors pointing out the possibility of anaphylactic reactions to Zomax.
The company also changed the warnings in each package of Zomax to include the possibility of anaphylactic shock.
But at the time, Zomax faced direct competition with two other arthritis drugs,
Auriflex from Lilly and Feldeen from Pfizer.
So one week after the warning letter went out to doctors,
McNeil embarked on a nationwide campaign to sell as much Zomax as possible.
On April 16, 1982, a mailgram was sent to every McNeil detail man in America from Tom Odeon, vice president of sales.
We're calling it Operation 111.
Now, if that sounds like war, well, in our world of selling, that's what it is.
Operation 111 was a massive sales campaign.
111 represented $111 million, the sales target McNeil wanted its detail men to hit.
We will take a tough effort by a tough sales force in the weeks ahead, and we're confident that you're that tough sales force.
Operation 111 begins immediately.
Remember, business belongs to those who ask for it. Tom Odeon, vice president of sales.
McNeil began sending mock war bulletins to the detail men, complete with crossed rifles and military language.
The company compiled lists of doctors who were heavy prescribers of painkillers
and set a goal for detail men to call on each doctor three times a week, each time leaving more samples of Zomax.
But the one thing the detail men were told not to do was to draw attention to possible allergic reactions.
In February 1982, a company-wide memo went out with a copy of an article from the Journal of the American Medical Association
documenting Zomax's side effects.
The McNeil memo said, quote, you should not bring up the subject or use this letter or article for detailing purposes, end of quote.
By April, the company was advising the sales force not to focus on anaphylactic shock,
but permitting them to discuss it as part of a balanced presentation.
But in May, Perez received another memo from his supervisor specifically instructing him not to mention side effects to doctors.
Suggest that you do not spend selling time initiating discussion on the Zomax side effects.
We have a lot of other products to sell and I feel that you should be concentrating your efforts on other items.
But as hard as McNeil tried to emphasize good news about Zomax, bad news was starting to come out.
Since first being introduced to the market just over two years ago,
Zomax has become one of the leading prescription drugs sold today.
Across the country, anaphylactic shock reactions, like those in Lubbock, were being reported.
One doctor in Syracuse, New York, who took it, passed out while driving and ran his car off the road.
And there were also reports of deaths.
This woman, Frances Porto, died two days after taking Zomax.
Her husband was shocked when nurses brought him the news.
One on each side of me said, Mr. Porto, Mrs. Porto died at 3.31 in the afternoon.
She said, we're so sorry.
I said, but I don't believe this. She only had bursitis.
McNeil says they reported all adverse reactions to the FDA.
But what the agency did not know about was McNeil's memos to the detail men
advising them to downplay the seriousness of the reactions to doctors.
Officials here say what a company chooses to tell its detail men is beyond the FDA's control.
Absent a whistleblower in the company or a fly on the wall,
it's not clear to me how we could have access to information about selling techniques used within a company.
We simply don't have the authority to go in and get that under most circumstances.
Back in Lubbock, the husband of a close friend of Perez's had a severe reaction to Zomax.
In July 1982, one year after he started selling Zomax, Perez quit.
McNeil offered him a raise and to move him to another territory, but he refused.
And I knew that I could have basically read my own ticket with him.
But I just, you know, whenever people talk of war and the damage that what war does,
well, in this instance here, I saw what war did.
And it wasn't purty.
And talking to people whose lives were destroyed, completely destroyed.
And I keep going back that it's $111 million worth that.
McNeil Pharmaceuticals sold $100 million worth of Zomax before it withdrew the drug from the market in March 1983.
The company would not grant an on-camera interview to Frontline.
But in a letter, they said they had, quote, acted responsibly and in the public interest, end quote, in their handling of Zomax.
They also say 15 million people used the drug safely.
The FDA estimates Zomax contributed to 14 deaths and over 400 life-threatening allergic reactions in its two and a half years on the market.
The FDA has a range of actions it can take to regulate drug promotion, from letters to fines to criminal prosecutions.
Some are made public and are considered more serious, and others are handled privately between the agency and the company in question.
In recent years, the FDA's enforcement statistics show a sharp drop in serious regulatory actions against drug companies.
In the years 1971 to 75, there were an average of 60 serious citations each year for promotional violations.
In the period 1976 to 1987, there were fewer than five serious citations each year.
I think what you have seen is a shift to a less confrontational approach,
a shift to an approach that says let's try to prevent problems before they need the kinds of remedial action that you've seen at times in the past.
And I think that some of the decline in very visible regulatory actions that you may be seeing may in fact reflect some success on the part of that strategy.
We've had a very lethal, dangerous partnership between the drug companies and the FDA,
wherein in instance after instance, the FDA has not used its authority to enforce the drug safety laws, to send letters,
chastising the companies to invoke criminal processes against companies for false and misleading, dangerous false and misleading advertising.
The non-confrontational strategy on the part of the FDA with respect to the industry is very good for the industry,
but it is dangerous, possibly life-taking for the American public.
Apart from the government, who is protecting patients against misleading promotion?
Traditionally, doctors have been the intermediaries between the companies and people who actually take the pills.
Dr. Sanford Roth is an arthritis specialist in Phoenix, Arizona.
One of his patients is Lowell Clements, who has suffered with a degenerative form of arthritis since he was nine years old.
The powerful drugs Mr. Clements takes to control his pain make him bleed easily. His arms are covered with bruises.
I think I've tried everything on the market.
Everything on the market.
Every new medication that had come out since I've had the affliction, since I was nine years old, I think I've tried everything on the market.
Now, let me ask you, just bend forward comfortably, don't force yourself as far as you can.
Lowell Clements' arthritis has progressed so far that he can only bend his body a few inches in any direction.
Now, let's try and rotate to the left side without moving the knees and to the right side.
Okay, now can you bend back towards me a little?
That's it.
But now, Dr. Roth has told him there may be hope with Mickey Mantle's new drug Voltaren.
We were waiting until the new drug Voltaren came.
Yes.
Well, immediately, as soon as they were able to obtain it, they put me on it.
That's nice of you.
Voltaren has a good safety record, and for now, Clements says it's helping him.
But when he got the drug from Dr. Roth, what he probably didn't know was that Roth played a significant role in promoting it.
From NBC News, this is Today.
Sitting next to Mantle on the Today show was Dr. Roth, and he too said wonderful things about Voltaren.
The most used drug in the world today outside the United States, we always hear we're in the back of the line, but now we're coming up front.
And the nice thing about this drug, there aren't any surprises.
We know just about everything we need to know about it and make it as an example of what it can do when people need that kind of help.
But Roth wasn't here simply as an independent expert.
He was paid by Seba Geige to promote Voltaren.
Using doctors to endorse specific drugs is another promotional tactic for some drug companies.
This is how it works.
A doctor like Roth is hired by a company which wants a study done, perhaps comparing its drug to a competitor.
The company pays Roth a fee, provides sample pills, and pays for any tests patients might need.
At any one time, Roth has about a dozen of these studies going on, involving about 300 of his patients.
What I've tried to do as carefully as possible is to be involved with as many different kinds of issues and people as possible.
Therefore, I don't know if it's been a half dozen or more companies at one time or another that I've been a consultant to, giving them advice on programs and education and research.
There almost isn't a company in the United States that I haven't done research for at one time or another.
Exactly what Roth gets paid for this research is confidential, but the income is a significant part of his practice.
He also profits when the companies use his research for promotional purposes, paying Roth to give speeches to other doctors, endorsing the same drugs he's been paid to study.
November 1988, Roth is a featured speaker at a medical conference in San Francisco.
Hi, Dr. Roth.
Hi.
Riker Labs, a division of 3M, has paid Roth to come speak here.
Ladies and gentlemen, fellow colleagues, I'm very pleased to be here.
Roth has a standard speech on possible side effects of arthritis drugs, and this time he added a section about an arthritis drug from his sponsor, 3M.
This is a drug that was introduced in 1924, South Slate.
Roth concluded that 3M's drug was safer than the competition.
And in 1982, Roth plugged yet another drug for Eli Lilly.
Roth was a paid consultant during the launch of Auriflex.
He authored favorable articles in two different medical journals, concluding that Auriflex was safer and more effective than competing drugs.
One of the articles was ghostwritten by a Lilly employee.
And he was listed in the Lilly Press Kit as a doctor happy to do interviews about Auriflex.
I think that the work that I did with Auriflex was good, incredible work, and I think that the drug itself was a useful drug, but unfortunately the problems with how it was handled were tragic.
But Roth is proud of his promotional work for drug companies and views his relationship to them as ethical.
He says doctors need the information and that the free and open marketplace serves patients well.
There will always be in our society a chance for all those many competitor sponsors to get our information in the other direction.
And I've been really proud to be considered an educator and being very active in various ways in my writing and my speaking programs and my university program and all of those programs.
We've received supports at different times and different ways.
And I think that our society is appropriately structured to allow this to continue in what will ultimately be for the good of the health delivery system.
Medical profession, unlike sports figures, have a code of ethics with respect to the public health.
Sports figures are not supposed to lie, cheat, steal, whatever else, but normally I don't think that they are under a Hippocratic oath that has to do with protecting their patients and the public at large.
So what we're really talking about is the ethics of a physician who, knowing if they really took a good look that the drug isn't really any better or different than another drug,
still gets paid to tell the public and use his or her prestige to push the drug.
I think this is a very questionable practice, which I would call unethical.
Roth is one example of a doctor with close ties to the drug industry.
But all American doctors are targets of promotional schemes aimed at influencing what drugs they give their patients.
It starts in medical school. Companies give students free stethoscopes and medical bags.
Then when they go into practice, there are numerous offers of what the companies call hospitality.
Some examples. Smith, Klein and French held a conference in San Francisco about a new antibiotic.
Doctors were paid all their expenses plus $500 to attend.
The G.D. Searle Company sponsored a meeting on a high blood pressure drug in Los Angeles, complete with tickets to the Super Bowl.
And Airst Labs organized a frequent flyer program where doctors who prescribed Airst's high blood pressure drug to 50 patients got a free plane ticket anywhere in the U.S.
In preparing this report, Frontline contacted many doctors who are critical of these practices, and some agreed to speak on camera about their concerns.
But most of them changed their minds before filming interviews.
Many said they were afraid to publicly criticize the drug companies.
If you add up the whining, the dining, the junketing, the research money, the thousand dollars for giving a speech, and so forth, you start including a large majority of all physicians in this country.
And therefore, we have a massive example of silence going on, the part of American medicine.
Everyone knows these things are going on. No one would deny them, because to deny them would be to lie.
And yet, to speak out critically, which we would think would be an ethical responsibility of physicians, just doesn't seem to happen very often.
Frontline also tried to talk to people inside the industry about promotion and marketing.
Fourteen of the largest pharmaceutical companies were asked for on-camera interviews. All refused.
And when the Pharmaceutical Manufacturers Association agreed to this interview, they set strict limitations on what could be covered.
One subject that was off-limits, they said, was any specific marketing or promotional practices.
Well, the Pharmaceutical Manufacturers Association is an association of more than 100 competitors in the research-based pharmaceutical industry.
And as an association of competitors, we do not involve ourselves and the Board of Directors does not involve itself in any decisions having to do with pricing or marketing or promotion or medical sales representatives.
And because of that, our counsel, our antitrust counsel, advised us to stay far away from that.
And because of that, I agreed with you in getting and agreeing to do this interview that I would not answer specific questions about specific company practices, because we're not involved in it and it would just simply not be an appropriate question.
One of the specific practices the industry won't discuss is this, all expenses paid trips to vacation spots, called Scientific Symposia by the industry.
November 1988, Seba Geige invites 150 doctors and their spouses to the deluxe Marco Island Resort off the coast of Florida for a weekend meeting on issues related to Voltaren.
The company paid the entire cost of the weekend, including airfare, rooms, meals, two receptions with unlimited cocktails and a Saturday evening dinner dance.
I want to thank Jeff Williams from Seba Geige for inviting me here.
On Saturday morning, five doctors gave speeches on arthritis treatment.
They were handpicked by Seba Geige and paid an honorarium.
The industry standard ranges up to $1,000 per speech.
The company gave frontline excerpts of two of the speeches recorded by a company film crew, but would not allow our own camera inside.
Only three and a half hours of the entire weekend were devoted to scientific presentations.
The rest of the time was free.
No one from Seba Geige would talk to frontline on camera.
Off camera, the company says the purpose of this meeting is purely educational.
Dr. Fred McDuffie, former medical director of the Arthritis Foundation, says it's understood that all the information presented will be favorable to the company's drug.
I think that most people that will accept an invitation to come to this, they will not knock that particular drug.
And if they have something negative to say about the drug, they won't be in their presentation.
Drug companies have held junkets like this one in Paris, Venice, Hawaii, and on vacation islands.
The American Medical Association has no rules about the ethics of doctors accepting free trips like this one.
I think that doctors, many of them are blind to the conflict of interest.
Doctors will deny that this has any influence on their prescribing practice.
The worry with any kind of conflict of interest on the part of a physician is that the doctors will make decisions about prescribing drugs that will not be based just on the best interests of the patient,
but which will be based on which company has been nicest to them.
I think it's kind of demeaning to think that doctors who are learned professionals, they've had great educations, they're practicing doctors, in any way can be promoted to do something that isn't in the best interest of their patient.
I refuse to believe that.
Most of the doctors attending the conference wouldn't talk to Frontline.
In fact, Seba Geige made an announcement encouraging doctors to refuse interviews with reporter Joe Rosenblum.
But the two doctors who did talk insisted this weekend will not influence them to prescribe more Voltarin.
I don't believe anybody would prescribe drug more because they came to a meeting put on by Seba. I don't think so.
I think it's a tradition in the industry that entertainment is a big thing in the pharmaceutical industry.
It's become a sort of way of life kind of thing.
In other words, there are so many conferences like this that they don't stand out.
They're not all that unusual.
Frontline estimates this weekend junket cost Seba Geige well over $100,000.
Researchers are beginning to study the overall impact of drug marketing and how doctors are actually affected by it.
Dr. Jerry Avorn is a specialist in internal medicine at Harvard Medical School and the Beth Israel Hospital in Boston.
Good morning. Hi.
Avorn recently published a study of how doctors decide what drugs to give their patients.
He says he found that a lot of doctors rely heavily on promotional materials given to them by the drug companies.
We found that in a large proportion of cases what they knew or thought they knew about the drugs
could not have possibly come from the scientific literature since the scientific literature didn't say that about those drugs.
It must have come from what they heard in promotional materials because these drugs were being promoted as quite good, quite effective, quite safe
when all the well-done scientific studies show that they were quite ineffective and in some cases dangerous.
Avorn also says his study points to a larger problem, overuse of prescription drugs, which puts patients at risk both financially and medically.
There are many, many patients whose pain would be relieved every bit as well and as safely by aspirin or by acetaminophen or Tylenol.
So on the one hand it's a cost issue. The safety issue is also present and that is that people are perhaps getting these drugs when they may not truly need medication at all.
When people are taking large ongoing doses of these drugs, even though their drugs have a good safety risk ratio,
there are going to be people who are going to be having side effects who might not have if we were not as a nation consuming so many tons of this stuff a year.
More prescription drugs are consumed in America than anywhere else in the world, $30 billion worth each year.
It's a perfect environment for aggressive marketing by the pharmaceutical industry.
The American public, they don't know. They don't know how intense this is, how conniving and what the company will do to get the physicians to go ahead and prescribe a drug.
As long as people have pain, as long as there is a need, you're still going to have people that are going to say we have to get the product to them.
Last month, the U.S. Department of Health and Human Services released a major study which concluded that faulty prescribing is a serious problem for older Americans.
It's been called America's other drug problem.
According to the report, one major factor in the number of adverse drug reactions among the elderly is their doctor's over-reliance on promotional materials provided by the drug manufacturers.
One final note about Voltaren, while its safety record remains good, the FDA has recently criticized Seba Geige for understating in its promotional materials the risks of kidney damage from Voltaren.
Thank you for joining us. I'm Judy Woodruff. Good night.
Behind the gleaming face of Dallas lies a war zone.
Police spend half a billion dollars a year fighting drugs, but they're losing the war.
I believe I could do a better job.
So the black community, at odds with the mostly white police force, is taking matters into its own hands.
We're challenging the pushers and the drug houses directly.
The Dallas Drug War, next time on Frontline.
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