SUSAN DENTZER: Tom, why did you take Lisa Williams's case?
TOM KLINE: I took Lisa's case because she was an active adult. She took a drug in good faith that she thought was being manufactured by a reputable pharmaceutical company approved by the FDA for a minor problem, a minor physical problem, and it ended up being a disaster in her life and causing her grievous injury. That's why I took her case.
SUSAN DENTZER: What do we think happened in Lisa's case?
TOM KLINE: We know what happened, based on the scientific evidence. Lisa took a drug called Vioxx. The drug was something that caused clotting. It was a COX-2 inhibitor known to be a problem drug even before Merck had manufactured and distributed the drug, and it caused her heart to--and her vessels to form clots, caused her to fall over, when she was an otherwise healthy lady, sustain a heart attack and severe damage to her heart.
None of that would have occurred had this drug been tested properly and kept off the market or tested properly and labeled properly.
SUSAN DENTZER: What's happened to her life since this occurred?
TOM KLINE: Lisa's life has totally changed. She was an active woman. She was a runner, a physical, physically fit young woman.
Today, her life has been debilitated. She is a woman who could not finish a Ph.D., which she was in the midst of. She has limited physical activity, and it's been a total life change for her. Her heart has been described to her by her doctors as the heart of an 80-year-old, rather than a person in her forties, and she is someone who has totally been changed, in terms of life, and lifestyle, and life outlook, by the drug Vioxx.
SUSAN DENTZER: And many of the experts Merck has consulted already in these cases have said, in situations like Lisa's, it's not necessarily clear that the drug caused the condition or, and it's going to be very difficult to establish that it contributed to the condition.
TOM KLINE: Well, I would disagree. Lisa is a woman who took the drug. It has been clearly established now by scientific evidence, not only the pharmacology of the drug, but also the epidemiology that's been done on the drug, finally, I might add, that the drug was a bad actor.
The proof of causation in Lisa's case is that she was an otherwise healthy person. She had no risk factors. She had no family risk factors, and here she took a drug and that drug caused her to have a heart attack. That, to me, is something that's provable in a court of law.
SUSAN DENTZER: Let's talk a bit about Merck here. You say that Merck knew for a long time that this drug could alter the clotting process.
TOM KLINE: There is no question that Merck knew and understood, before they manufactured this drug, that the drug was a problem. They knew from its pharmacological properties as a COX-2 inhibitor, in fact, this particular type of COX-2 inhibitor, that it was subject to and it was going to cause clotting.
Therefore, it was going to subject anyone who took it, minor or major ailments, to the risks of a heart attack and a stroke, and I might add an increased of a heart attack or stroke. That was just based on the pharmacological properties.
In other words, based on the pharmacological properties of the drug alone, before any human being took the drug, this particular formulation was known to, and understood by Merck, to cause the exact kind of problem which when the human population was subjected to it en masse it caused.
The early studies and the early data, which clearly were available to Merck, based on information that's now well out in the public--there's no secrets about this. It's well known by now--the early studies showed that there were increased risks of heart attacks and strokes in people that took this kind of medication, this particular COX-2 inhibitor.
Then, Merck decided never to study the drug for safety, for cardiovascular effects. There were never any cardiovascular safety studies particularly designed to prove that the drug was safe that were done before it was marketed.
So, yes, Merck knew. Merck understood that there were risks. Merck decided not to do any kind of real testing.
The testing that Merck decided to do, which was simply to test the gastrointestinal effects of the drug, even those studies, with a selected population base, demonstrated to Merck that there were problems. Every red light that could have been put up at every corner for Merck to stop, and look, and listen, Merck ran through in this particular, in this particular drug.
SUSAN DENTZER: Let's talk about the APPROVe trial. Merck officials say they explicitly were told by the FDA to put in cardiovascular safety as one of the endpoints of that trial and that that trial was getting underway in 2000, just months after the drug was approved.
So Merck says it was, in fact, studying the cardiovascular risk early on.
TOM KLINE: Well, Merck was not studying cardiovascular risks in 1997, 1998, and 1999, when they were testing drugs. In those days, they were doing 90-day tests. They were largely testing for gastrointestinal effects of the drug to see whether it was safe, from a GI point of view. So they were not testing the drug in the kind of manner that you would expect a reputable and a responsible pharmaceutical company to do. That's just not the case.
When they finally got around to testing the drug in any kind of way that was going to give any kind of data, it was well after the year 2000, and there they weren't testing in the proper, safe, approved, known epidemiological fashion, the drug for cardiovascular effects, when this very drug, this very drug was known to pharmalogically be a bad actor.
SUSAN DENTZER: Now, Merck says, at every step, Mr. Gilmartin specifically said this to me last week, at every step of the way, we put patient safety first.
TOM KLINE: Well, at every step of the way, Merck put patient safety last, in terms of Vioxx. There is no doubt about it. Merck should never have marketed this drug in the first place. This drug was a drug where Merck put profits ahead of people, where Merck put marketing ahead of safety. Here was a drug which was used for minor aches, and ailments and pain, which had, as its result, heart attacks and strokes. You make that risk-benefit analysis and tell me where you come out.
SUSAN DENTZER: What Merck says is that this is the only COX-2 inhibitor that was shown to cut gastrointestinal side effects in half versus the other COX-2s or other NSAIDS, that, in fact, for many people it was the only effective pain relief that they could obtain through NSAIDS, at a much, much lower gastrointestinal risk, which puts a lot of people in the hospital and kills a lot of people itself.
TOM KLINE: Well, the real facts are that there were numerous drugs which were either developed or about to be developed which were COX-2 inhibitors, including Celebrex, which Merck was about six months behind and trying to play catch-up.
The fact is that this particular drug, the trade-off, in terms of the risk-benefit analysis, so heavily weighed against the manufacturer of the drug or the manufacturer of the drug, for very narrow, specific reasons, with very bold and bright warnings, that there is no way that Merck can justify having marketed this drug on the basis of saying, "Oh, well, this was a COX-2 inhibitor which greatly would affect and help people who have significant GI problems."
If that argument were true, then Merck simply should have marketed the drug for a narrow class of people who were going to use this drug as a last resort. Did they do that? No. Instead, Merck went out, and they manufactured the drug, and promoted the daylights out of the drug, to the point where it became a $2.5 billion cash cow for them. That was wrong, and that's where the mistake was made.
SUSAN DENTZER: And Merck's response to that is, "We marketed this drug entirely within the FDA-approved indication for it."
TOM KLINE: Well, this is one of those cases where the FDA was dead wrong, and Congress should look carefully at the way that the FDA approves drugs because this case is a case example, a living example of how people get hurt when the FDA isn't vigilant. This is a case where Merck and the FDA had a symbiotic relationship, and it was designed to get a drug on the market. It wasn't designed to protect the public from a drug that may hurt some people or, in this case, many people. To add insult to injury, in the VIGOR study, from what, again, is publicly known and well--and well said at this point in the public arena, in the VIGOR study, what you had was a selected population so that Merck, itself, was picking the most healthy people to study rather than the people who were at the greatest risk.
If Merck had selected a true, randomized population, more so what was done in the approved study, they would have found out much earlier that this drug was a, was as bad an actor as they eventually had to admit.
SUSAN DENTZER: After the VIGOR results were published, there was much debate over what they meant specifically with respect to the higher cardiovascular risks. And we now know that there was a lot of e-mail traffic, internally within the company, to discuss those findings.
TOM KLINE: In the published reports, in particular, the Wall Street Journal article recently, it's been made known to the public that there were significant amounts of, of e-mails and correspondence within Merck.
It strikes me that what Merck was doing here was trying to underestimate the risks of Vioxx, and they were looking for a way to try to paper over or to paint, in a favorable light, what were obviously telltale, ominous signs.
So what Merck decided to do, without a doubt, was to say that Naprosyn had a protective cardiovascular effect. The fact of the matter is that that just doesn't make sense. It would be, to quote a term that sometimes is thrown at lawsuits brought on behalf of patients, it's junk science to suggest that Naprosyn would have a cardiovascular effect long term for patients who were on that drug. It is clear and evident that, based on even a selective, healthy population group, which was used for the VIGOR study, that the results still were showing telltale signs of people having terrible effects and having a dramatically increased incidence of heart attacks and strokes.
What Merck did was, like an ostrich, to put their neck into the sand and hope that not only they couldn't see anything, but neither could anyone else.
SUSAN DENTZER: But when the FDA put all this before its advisory committee, composed of rheumatologists, cardiologists, people from all medical persuasions, really, of interest in this trial, they couldn't make up their minds about what was really happening.
TOM KLINE: Well, they couldn't make up their minds because of a number of factors. One of the factors was that Merck, in the first instance, didn't study the drug appropriately. They didn't do a--they didn't do the appropriate cohort study, they didn't do the appropriate epidemiology. They hadn't studied the drug in the appropriate safety tests, not gastrointestinal safety, cardiovascular safety.
So, if you put incomplete data in front of a group, and then you lobby that group to say this drug is safe, it puts the kind of burden on the FDA and the kind of burden on an advisory committee, that stacks the cards in favor of Merck, stacks the cards in favor of the pharmaceutical company, stacks the cards in favor of keeping the drug on the market.
If the advisory committee had looked at this in an open, objective way and had had all of the data that we had from the approved study in front of them, the same result would have occurred. They would have taken the drug off the market.
This is a collosal failure by Merck and by the FDA, make no mistake about it. How can anybody justify that they don't even get to complete the APPROVe study, that the drug is pulled off the market in rapid fashion. Yet Merck was touting the expansion of the drug to children a month earlier, that the FDA had said everything was fine.
There can only be one answer to that--lack of data or lack of will. And, in this case, the FDA is guilty of both. Merck is guilty of a lot more.
SUSAN DENTZER: Let's talk about specifically the indication for children
TOM KLINE: Just one month before they pulled the drug off the market, Merck was busy at work attempting to convince the FDA to expand the use of the drug for use in children, in children who had rheumatoid arthritis. And there could be no better evidence than that piece of evidence in showing just how reckless Merck was in this particular case.
SUSAN DENTZER: The APPROVe study showed that there was only this risk increase after 18 months, yet Lisa was on VIOXX for two and a half months.
TOM KLINE: Yes.
SUSAN DENTZER: How does this add up?
TOM KLINE: Well, first of all, the missing data is from Merck not from any individual or any individual's lawyer who brings a lawsuit against Merck in terms of failure to identify fully the risks at an early point in time. How does it add up is your question. Here's how it adds up.
It is clear not only from the APPROVe study, but from the entire picture, which includes Merck's early studies, which were only done at 90 days, which clearly showed increased risks of heart attacks. It was clear from the VIGOR study that there was an increased risk of heart attacks, and strokes, and cardiovascular conditions. It is evident, from the pharmacology of the drug, that the drug causes this particular kind of condition.
The fact that the one study which was done, although not completed, but the one study that was done in a systematic, scientifically acceptable way as a safety study for cardiovascular risks, the fact that that one study described the outcomes at 18 months does not mean that there's a hole in a case where there is a period of time which was less.
The combined evidence of the early studies which were being done by Merck on 90-day trials, with the VIGOR study, with the approved study, with the pharmacology of the drug in hand, showed that the evidence is clear and overwhelming that the drug causes this kind of condition. All combine to lead to only one conclusion, that Lisa's case, like many other cases where people are on the drug for less than that period of time, are also scientifically sound.
The fact that Lisa was on the drug for less than 18 months, in fact, far less than 18 months, does not mean she has any less of a case. When you combine the early studies, at 90 days, showing that there were increased risks of cardiovascular problems, the VIGOR study, and the approved study, and the pharmacology of the drug, the conclusion is inescapable that that's why this young, healthy woman fell over on the lawn and suffered a heart attack.
SUSAN DENTZER: We've spoken with some observers of this field who say that, to the best of their judgment, what happened here was that the--Merck was playing by the rules, as they exist today, for pharmaceutical companies, in terms of getting drugs approved, studying them on a post-marketing basis, et cetera, that the FDA was playing by the rules as they are currently constructed. And the problem is not what Merck or the FDA did under the existing rules, the problem is the rules, that the rules simply are not adequate to deal with the situation of drugs now that are mass marketed to chronically ill populations and will be consumed over a matter of years.
So that really what we need to do is change the system, rather than, as one person said to us, go on a witch hunt after the FDA and Merck. What do you think?
TOM KLINE: FDA, Merck was not playing by the rules. Merck had evidence that the drug was a bad actor. They didn't come forward and tell the FDA that this drug was a problem. Massaging and manipulating evidence, massaging and manipulating the scientific studies, that's not playing by the rules.
SUSAN DENTZER: What about the FDA?
TOM KLINE: The FDA, the FDA, unfortunately, spends too much time worrying about what the drug companies think and what the drug companies want than on public safety. And if, if someone wants to make the argument that technically the FDA was playing by the rules, in the sense that they were merely enforcing their, their regulatory authority, then that's a, a piece of evidence that the jury is still out on.
I think that the story will develop more completely as to whether the FDA made terrible mistakes along the way. I would say it this way, alternatively.
There was a terrible mistake made here in manufacturing and distributing this drug and in approving this drug. That much is known. The only open question is whether the FDA, in addition to Merck, has some real blame here, and that's going to be, I'm sure, the subject of congressional investigation, as well as an awful lot of other investigation as the facts occur. There is, there can be no sensible and rational justification or rationalization for how this drug got on the market, and stayed on the market, and was taken by millions and millions of people when it was clearly a bad actor and all that needed to be done was an appropriate safety study to prove the point.
How can that be playing by the rules? How can that be having the appropriate rules in effect? How can that conceivably be appropriate conduct by a legitimate and responsible pharmaceutical company? It just can't be.
SUSAN DENTZER: What are you asking for from the court in damages in Lisa's case?
TOM KLINE: There is no set of amount of damages that are requested in a case like this. This is a case in which Lisa has just suffered a tremendous debilitation and alteration of her life. She is at, clearly, an increased risk of death. It's terrible to say that, but--with her sitting next to me--but it's true.
And so the damages some day will be decided by a jury. It's too early to put a figure on this case or other cases. It is clear, however, that this is an example of the kind of case where misconduct needs to have recourse in the courts, and Lisa is going to bring her case some day in front of a jury, and hopefully on that day, that jury will assess the conduct of Merck as to their irresponsibility in having these pills in her hands, to be taken by her to cause this horrible injury.
SUSAN DENTZER: What do the results of the APPROVe study tell us?
TOM KLINE: The inferences from the approved study are clear that thousands of people in the United States and around the world suffered heart attacks and strokes as a result of the ingestion of the drug Vioxx. It's that simple. If you extrapolate from the study, it is clear that thousands of people suffered heart attacks, and strokes and many of them died.
SUSAN DENTZER: Where is the Vioxx litigation headed? There have been any number of suits now filed both in state and federal court, one, at least one class action. Where is this going?
TOM KLINE: It's likely that there will be thousands of claims filed in various courts around the country, some in state courts, some in federal court, and it is likely that there will be a large concentration of cases in the New Jersey state court, where Merck has its, its headquarters.
SUSAN DENTZER: Would the expectation be that Merck will end up with making a large settlement, just to clear the decks of all of these cases eventually?
TOM KLINE: It is too hard to tell and too early to predict what Merck's real attitude will be towards the Vioxx cases. As is the case in many of these so-called mass torts, the course and direction will be determined by the discovery in the case, by the lawyers and the legitimacy and the strength of the various claims.
Not all claims stand equally, and in typical fashion, which I think will be the case here, these cases will sort themselves out. The battleground in the case that I predict that Merck will take will not be on its own conduct. Eventually, they will, by necessity, be forced to concede that they made critical errors.
The real battleground will be over the extent of the injury of the various claimants and the cause-and-effect relationship of the drug Vioxx. That obviously changes in individual cases. It's something that each individual's case can be assessed on its own merits, and that's the real litigation battleground in cases like this.
SUSAN DENTZER: So that is another way of saying, in effect, that, first of all, they know that the drug caused injuries. That's been established now. The question will be determining whose injuries were caused and what was the magnitude of the injuries caused?
TOM KLINE: I think that ultimately the real question will boil down not to the conduct of the company, which will be well established to be very bad. It will not be that the drug itself causes the type of injury claimed, namely strokes and heart attacks, because that's already been established by the studies, in particular, the approved study.
The central issue, in most of these cases, will boil down to whether the drug caused the individual claimant's injury based upon that person's background and predisposition, as well as, as well as risk factors that that person had coming into the taking of the drug, in addition to the extent of the injury suffered by the, by the party bringing the claim.
SUSAN DENTZER: Stepping back from this case, what is this a case study in?
TOM KLINE: This is a case study in the failure of a major American pharmaceutical company to test its drug for safety before marketing the drug to millions of people. It's that simple of a proposition.
SUSAN DENTZER: And stepping back even an additional step, do you agree with the statement that the system needs to change?
TOM KLINE: I believe that, in this case, Merck, regardless of the regulatory process, is responsible for its own conduct. If there had not been an FDA in the United States of America, Merck would still be responsible to manufacture a safe drug--not only an effective drug, but a safe drug.
As to the question of whether the system should be changed, the answer there is, yes, but we should not put the wrong emphasis on this. The FDA has had major failures, without a question, in this particular case.
Having said that, that does not exonerate Merck from responsibility for its own conduct. The system should be changed. Drug safety should be paramount. It is an industry that generates tens, if not hundreds, of billions of dollars of revenue and profits a year for drug companies. They have a responsibility to do the appropriate testing. A pharmaceutical company has a responsibility to manufacture and to distribute safe pharmaceuticals.
Having said that, oftentimes we need to force people into behaving appropriately. So, if we know that pharmaceutical companies don't behave themselves, then obviously the recipe for changing that is to have stricter laws, stricter rules, and stricter enforcement.
Having stricter laws, stricter rules and stricter enforcement is a good recipe for the future, but it does not excuse the conduct of the past. If there had never been an FDA approval needed for Vioxx, it still should not have been marketed by a responsible pharmaceutical company that knew in advance the propensity of the drug to cause harm, period.
SUSAN DENTZER: Lisa, how do you feel now? What has this done to your life?
LISA WILLIAMS: It has devastated my life. It has changed the way that, that I'm used to functioning. For example, I'm used to making long-term goals and things like that, but because my future has become so uncertain, I have to live day-by-day, and oftentimes I, due to my health, before, because I was physically fit, my health really was not an issue. But now, since this has happened, my health is, is the most important thing I have to focus on.
I have to spend a large, the majority of energy on health issues. It's basically taking over my life.
SUSAN DENTZER: How do you feel, when you think about Merck having brought out this drug, the fact that you took it for two and a half months and this is the result? How does that make you feel?
LISA WILLIAMS: For one, it makes me extremely angry because, as consumers, we're taking medication that is supposed to make us feel better, we end up, it ends up that you're destroyed by medication that was put on the market that we presumed was safe. I, I feel sad about the issue because I don't feel a value was put on human life, and that makes me, it's very deplorable when pri--when profit is more important than people's life.
I deplore the fact that, that profit was put ahead of human life.
SUSAN DENTZER: And you feel that's what Merck did?
LISA WILLIAMS: I do. I believe they did.
SUSAN DENTZER: Tell me what happened
LISA WILLIAMS: Okay. I was--had a very, an exercise program where a part of my exercise program including running about two to three times a week. I developed a painful bone spur. I went to the podiatrist, and I was given a prescription of Vioxx to alleviate the acute pain associated with the bone spurs.
I had taken Vioxx for approximately two months. The last tablet I had taken from my prescription the day after I had taken the Vioxx medication, and that was on August 30th I suffered a heart attack.
SUSAN DENTZER: And paint the scene for me. You went running. You were out visiting your relatives.
LISA WILLIAMS: Right. I was out in South Dakota visiting relatives. That day, I had prepared a large meal, and I had waited a couple hours before I went running. I--that day I went running, it was a beautiful August day, and I had ran about two miles by the time--I had reached the lawn of my grandmother's house when I--excruciating pain had caused me to collapse.
I was able to crawl. I could barely--I couldn't really stand up because the pain was, had started in my chest, and it had radiated down my arm, and it--the pain, the origin of the pain was actually somewhat ambiguous because it was also in the stomach region. And I was, after I had collapsed, I was able to crawl into the--my grandmother's front door. And the only thing I could do was just collapse on the couch, and I had flu-like symptoms because I started vomiting.
I, at that time, because I didn't have risk factors for a heart attack, it didn't occur in my mind that this is a heart attack. I thought possibly I had eaten food that was spoiled or I thought possibly I had ran too, you know, I didn't wait two hours before I jogged, and that had caused me to vomit because I hadn't digested my food properly.
And I recall just falling asleep because the pain was devastating. When I woke up--I, I must have fallen asleep for about 10 or so hours--when I woke up, there were--my family was home, my son and my mother--and I recall I couldn't get off the couch, and they were able to take me to the, you know, both of them had to kind of carry me out to the car, and they drove me to the emergency room. I, I was given, I had told the doctor what, what my symptoms were, and they did an EKG, which showed that I had suffered a heart attack.
SUSAN DENTZER: How did you feel when you learned that?
LISA WILLIAMS: I was, again, devastated, because I hadn't had the risk factors. I was frightened because, you know, a person my age having a heart attack is, is very rare. And, you know, I thought, well, I'm going to die, you know.
SUSAN DENTZER: And we should just put on the record here that you were 43--
LISA WILLIAMS: Forty-three, right.
SUSAN DENTZER: --when this happened. You then had some additional tests done and eventually some surgical interventions. What were those?
LISA WILLIAMS: The surgical interventions I had was an angioplasty in, well, initially, they gave me an angiogram, which, and then they had to do an angioplasty, and because one of my major coronary arteries were severely damaged, they had to place three stents in one of the major coronary arteries. It's called the LAD artery.
SUSAN DENTZER: What does your doctor say is the status of your heart today?
LISA WILLIAMS: My doctor said that the current state of my heart is that of an 80-year-old person.
SUSAN DENTZER: Even though you're 48.
LISA WILLIAMS: Correct.
SUSAN DENTZER: How does that make you feel?
LISA WILLIAMS: It, again, it makes me feel that my future is very uncertain and that the quality of my life has been greatly reduced due to this, due to the heart attack.
SUSAN DENTZER: Do you recall seeing the advertising about Vioxx while you were taking the drug, and, if so, what did that make you think about the drug?
LISA WILLIAMS: I believed the drug was, was very safe. I had--the advertisement, at the time I was taking the drug, was putting emphasis on the fact that the drug does not cause the common side effects that other NSAIDS do, which is the gastrointestinal bleeding.
I thought the drug would be extremely safe.
SUSAN DENTZER: And did you have any reason to think that you might have some gastrointestinal issues? Did you have any reason to want to take Vioxx for that purpose--specifically, because it had less of a risk?
LISA WILLIAMS: I, myself, didn't have any reason to be concerned, other than that I had heard that that is really adverse side effects of aspirin. So it, it motivated me to try to find a medication that didn't cause those side effects.
SUSAN DENTZER: And let's just talk briefly about what disruption has occurred in your career as a consequence of your heart condition. You were in the middle of pursuing a--you have a master's degree in biology?
LISA WILLIAMS: Biology.
SUSAN DENTZER: So, if you could, say that. Say, "I've got a master's degree in biology. I was working on my Ph.D. I have now had to abandon my Ph.D. studies, and I'm trying to go on--I really don't have any choice at this point, but to go on disability," if you could say that. So, give me a sense of what impact this has had on your career.
LISA WILLIAMS: Well, before this occurred, I was pursuing a Ph.D. degree in molecular biology. For a short while, I was able to re-enter the program, but due to some of the lethargy and effects of the medication I was taking, I am no longer able to--I've had to abandon my program.
And, currently, my physician recommends that I apply for short-term disability.
SUSAN DENTZER: What do you think is ahead for you?
LISA WILLIAMS: Right now, it's hard to say. What a lot of--my goals now are dependent on the sta--my health, the status of my health.
SUSAN DENTZER: What do you hope to get out of bringing this lawsuit?
LISA WILLIAMS: For one, I hope that the lawsuit will have an impact on the way that new drugs are regulated. Also, I feel that individuals that have, like myself, that have been injured as a result of this drug are in some way compen, compensated so that we can get our lives back on track. I believe that the FDA regulations should be much more stringent than it is now.
Also, I believe the victims, people that have been injured, like myself, will in some way be compensated to help us try to get our life back on track.
SUSAN DENTZER: Let's talk about did you have any cardiovascular risk factors?
LISA WILLIAMS: I did not have any cardiovascular risk factors. Also, I did not, in my family, there is not a history of cardiovascular or coronary artery disease.
It just, the heart attack just seemed to have come out of the blue.