Case study
Do you want to change your life? Well, Tony Quinn will help you for just £15,000. And don`t worry if you don`t have the cash because he`ll also help you to get that, too. In the first of a two-part series, The Sunday Tribune examines how his organisation operates and finds money to be a top priority
Harry McGee
Richard Oakley
It drops through your letterbox a couple of times a year, along with all the unwanted flyers from auctioneers, Indian takeaways and late-night pizza joints. The first thing you notice is that vaguely familiar face that beams out at you from the cover - that long jaw, the neat beard, the damson-cheeked smile and that oh so 1980s coiffure. "Dr Tony Quinn," it always says, "doctor of clinical hypnotherapy, Master of Science in psychotherapy."
Blueprint for Successful Living. Only good news, it promises. There`ll be at least 30 photographs of people with chorus-line smiles. There`s always an interview with the great one on the cover, which reveals a man not overly familiar with the concept of modesty.
Q; How would you describe yourself?
A: In many ways as a philosopher... What happened in my own case is that I spent so much time trying to learn the secrets of life that I began to have insights.
The good doctor is always involved in some ground-breaking research that`s "causing a stir in scientific circles" In universities everywhere, academics are poring over his findings with barely concealed envy.
Q: Tony, you`ve just completed what has been hailed as ground-breaking research.
A: Yes, the study took place in conjunction with a university and under university research conditions.
The strange thing is that there`s one thing that`s never advertised among all the seminars, and ki-therapy courses, and successful living tapes, life-extension mixes, postal requests and slimming formulas that fill the space in Blueprint. Strange, because it is the one vehicle that has elevated Tony from being merely rich to being a multi-millionaire, living in the tax haven of the Bahamas , the "highly favoured cruise destination of the rich and famous", as Blueprint describes it so eloquently. We`ll phrase it in Blueprint`s own inimitable style:
Q: How did Tony make his millions?
A: By getting hundreds of people to go on his Educo seminars at £15,000 a pop.
Sometime between the late 1980s and early 1990s, Tony Quinn - former apprentice butcher, former body-builder, former yoga guru - reinvented himself. Armed with his doctorate, and later his masters, he devised the "Educo" system, which he described as new mind technology. His "mind-training" of boxer Steve Collins when he became world champion gave the Educo system a huge - and continuing -advertising boost, though Collins wouldn`t share Quinn`s view of his role. "He was one of many people who helped me on the way. He was useful for a little while. I used a couple of hypnotists to help me focus. In my opinion, the best of them all was Tony Sadar," says Collins.
The connection did Quinn no harm. In the past four years, his courses have mushroomed from short local seminars to two-week courses in exotic climes, run on an almost monthly basis. In the same period he has built up a following of what may be thousands of supporters, some of whom believe him to be world`s best life coach. An estimated 600 of these - some sources say many more - have gone on these £15,000 seminars, some more than once, where he promises to dramatically change your life by using "unconscious attention".
Quinn says he has developed a breakthrough system. He claims to be more than a new age or alternative therapy guru and can point to 18 qualifications, to his systems and theories which he says are validated by original research carried out in conjunction with universities.
However, an in-depth investigation by The Sunday Tribune (in conjunction with TV3`s 20-20 programme) shows that Quinn`s organisation is a business empire with financial gain a priority, using hard-sell techniques that push the concept of OPM (Other`s People`s Money) to its limit, and includes sell-on procedures that are designed to increase recruitment. The investigation also shows that some of his qualifications are not all they appear and that elements of the research and the theories he has built his system on have little scientific basis, according to two of Ireland`s leading academics.
The one aspect of Quinn`s organisation that is never advertised in his Blueprint for Successful Living are his seminars - the mainstay of his business for the last number of years. The basic one costs £15,000 for a two-week course held at a sunny resort. It is believed there are more expensive options where the customer receives one-on-one attention from Quinn. Representatives of Quinn say that the seminars are advertised within the organisation and that news of them is spread by word of mouth.
The Sunday Tribune, however, has for the first time secured tapes of what is said at these seminars and found them to be sold on a hard-sell basis. There is evidence that Quinn tells people, while under his influence at the seminars, that the best way for them to realise the life of their dreams is to sell his seminars to others. And it can be shown that whether or not you have the finance to attend is not a problem as Quinn`s organisation can point you in the direction of someone who can lend you the money.
Money, and the attainment of it, in fact, is one of the recurrent themes of all Tony Quinn`s seminars. You can get that sport`s car, that holiday, those riches, that successful life you dream about, he promises. "Imagine the following ideal scenario," he says in one seminar. "You have left your penthouse on Paradise Island and you are out in your yacht on the bay... You are sitting with a group of friends and they are envying your lifestyle. They ask how you achieved it. You talk about the seminar and how you went from fixed to flow and self-expression; of the exciting adventures you are having since living outside of thought."
It`s almost as if Quinn is describing himself. The man born in a small cottage on Arbour Hill in Dublin 55 years ago now lives in a luxurious mansion in the Bahamas , a tax haven. The company that runs his seminars, Human Potential Research Seminars Ltd, is registered in St Helier, Jersey , and thus is not subject to Irish taxes.
A lifestyle like that of Quinn`s is what he promises his followers. In a tape recorded at one of his seminars, Quinn, having put his audience in a relaxed state, tells those attending to picture an exotic island with a cave in the middle. He then tells them to go into the cave where they find jewels and riches. Listeners to the tape can hear hysterical calling out, loud laughter and shouts of joy from those at the seminar who are clearly under Quinn`s influence. His talk is delivered in his slow voice and strong Dublin accent.
"And go inside now, go inside now and see this incredible treasure. Wow, look at that treasure, look at all those gold bars, aren`t they beautiful, see all those jewels, wow, run over there and run your hand through all those jewels. And look as far as your eye can see, all that treasure, mountains of it, it`s beautiful, wow it`s beautiful. It is all yours. You are going to mine all of this. And it is unlimited and never ending," he states.
Not everyone who attends can easily afford £15,000, but it appears this is not an obstacle. Representatives of the organisation, in an interview with The Sunday Tribune, say it is often the case that people are advised to borrow money to go on one of Tony Quinn`s seminars and readily admitted that they can point people in the direction of specific money lenders that have a working knowledge of Quinn`s system.
"Look at it this way," says Martin Forde, a spokesman for the Quinn organisation. "What`s it going to cost you to buy a car? What`s it going to cost to take a year out and do a university course?... Some of the guru business people, Tony Robbins for example, cost much more. The level at which it`s pitched is comparable to all other types of mid-life reorientation training."
Some of those encouraged to go told The Sunday Tribune that the enthusiasm shown by Quinn`s supporters made them feel compelled to attend, even if they couldnt afford to. One woman, Kathleen White from the Lough area in Cork , says she was advised to remortgage her house to find the £15,000 seminar fee.
Some former Tony Quinn staff members say that they also came across hard-sell techniques. They say that other members of the organisation aggressively marketed the seminars and would go out of their way to convince others to go on them. Two people to whom The Sunday Tribune spoke severed all connections with the organisation soon after the £15,000 seminars were introduced because of their unease about the manner in which they were being promoted.
During this investigation, a reporter built up a relationship with an employee of Quinn`s, who runs one of his health stores. The woman heavily promoted the seminars when the subject was raised and suggested the reporter borrow from a bank or a credit union to finance his attendance. She said not to tell the institutions what the money was really for but to say it was for a car or a holiday.
She said the money could be made back easily. The Tony Quinn organisation admitted that people are encouraged to tell other people about the seminars and that some people may do so a little too enthusiastically. "The best way to have the life of your dreams is to show people how to live the life of theirs," is one of the points made. However, Quinn`s representatives, Martin Forde and Colette Millea, say people would never be encouraged to lie to financial institutions.
They confirmed, however, that there is a financial incentive which effectively encourages people to sell the seminars. "We know the average person can`t pull £15,000 from their back pocket," said Forde. "What we will say to you is that you are likely to be able to pull it back very well and that will apply for promotion in a job, starting a business or expanding an existing business. Or if you decide that you can send a couple of people out, you could do that." They also confirmed that there is an official system in place whereby people can sell seminars to others. They said, however, that only people who request to be part of the system are included. A person who has attended a seminar is urged to get others to attend subsequent ones. If a new customer signs up for a £15,000 seminar, the person who made the introduction gets £1,000, and if the newcomer then introduces a new customer, the original agent gets a further £2,000. The agent, however, must commit to going to at least one Quinn seminar a year.
"Many people find that everything can expand if they get other people to go out [to the seminars]," said Forde. "People will be encouraged to talk about it, to actually give it away... That`s the phrase that`s used, to give it away."According to the Quinn organisation, a person can make their money back in this way with little effort. It is described as a unique financial opportunity Ð a statement repeated over and over again.
Also central to Quinn`s theory is the idea of OPM (Other People`s Money). Quinn claims that anyone who has become rich and famous has done so using OPM or credit. He says that people like Aristotle Onassis and Richard Branson became rich through using other people and he and his organisation use this idea to promote their seminars and to encourage people to borrow money to attend them.
The Sunday Tribune has obtained a copy of a document entitled "Onassis: living in the money flow" and another called "Financial Freedom". They are clearly marked with a special note which states that they are "intended only for people who have completed at least a two-week seminar". In the Onassis leaflet, OPM is explained and the idea of paying as little tax as possible is outlined. "By using other people`s money and in turn paying minimal taxes, Onassis accumulated a stupendous fortune," it states.
The financial freedom document is described as a blueprint that can take a person "into another dimension of living". "I believe that when you experience the results of the seminar, you will want others to share in the benefits," Quinn is quoted as saying. But it would seem that the main motive for sharing the dream with other people is to get them to go on the seminar as well.
"...You can do the perfect work of helping people and have the life they want. This gives you an ever-growing circle of friends who truly owe their lives to you. In addition, you have ever-growing financial freedom to practise the art of ultimate living in any country that you choose."
These documents reveal the emphasis put on sales techniques and of encouraging people to sell the seminars. However, they only give a small indication of the out-and-out hard-sell spin Quinn has used in at least one of his seminars that The Sunday Tribune knows of.
In the tape mentioned at the beginning of this article it is apparent that the people Quinn is talking to are under his influence. There are hysterical sounds from the crowd. At the beginning, Quinn makes them concentrate on relaxing. When they are relaxed, he then sets about explaining the selling technique that "never fails" and tries to convince those present that the only way they can live the full life of their dreams is to sell the seminars to other people.
Sean Collins is a hypnotherapist and president of the Irish Institute of Counselling and Hypnotherapy. Having listened to the tapes, he said: "It sounded as if [the people] were in an altered state and [Quinn] was guiding them into some sort of delusional place because he was absolutely leaving out any possibility of failure and possibility of negativity. This is always worrisome because the reality is that things go wrong in life."
Spokespeople for Quinn denied that negativity and the possibility of failure were excluded from the seminars. They said what Quinn does is stack the odds in people`s favour. They also said that the people on the tape may have requested the seminar.
The following is a sample of some of the things Quinn tells those attending: "So just close your eyes now and let yourself begin to relax. That`s it. And let yourself now become more and more relaxed. As if you were going to just blend into the seat. And realise now that your mind is going to absorb this material and it will absorb it so much that you won`t really have to do anything about it. It will just start happening to you" It is so wonderful to be able to just walk up to people, which you can now do, and you can now say "I have the answer for you". You can say "If you want that life of your dreams and you want to be able to mine your unlimited treasure, then now is the time". You can tell them to take that ultimate adventure and really live, to really take that chance, that brave step and do the seminar. Of course, you know in reality that they are not really taking a big chance. They are just spending the price of a car. So let them see that you have done the seminar and reached a point that they can reach, the same point that you are at... where you are demonstrating to them now the selling system that never fails. You are demonstrating that to them. That`s it. To achieve that state of mind the seminar will help them to go from the point where they are at to the point where they want to be Let them see that you have this ability to operate this mental state of mind." That`s it and in this way now, you are doing the same work that I do. And from now on with each second you are gaining greater, financial freedom. And you are beginning to have the same lifestyle as I would have."
It should be noted also that during the seminars Quinn refers to opposition and negative thoughts. He tells those attending that they must block out all opposition and negative thinking and not allow it to stop them in their mission to sell his seminars so others can have the life of their dreams.
When he was a teenager, Tony Quinn idolised Charles Atlas, the puny kid who overcame getting sand kicked in his face to become Mr Universe. Quinn has said that he had exactly the same dimensions as Atlas at one time and refers to the fact that he has won "about 12 body-building contests in total including Mr Ireland ".
If you flick through Blueprint, you quickly notice an almost obsessive interest with the body beautiful and with the ageing process. The most extreme example of this is Bob Delmonteque, an 81-year-old man with a bodybuilder`s body.
The second obsession seems to be with Quinn himself. His smiling image is pervasive, he is always interviewed in the magazine, his name crops up more often than a Murphy in Cork . Some former employees and observers say that there`s a messianic aspect to Quinn and that something of a cult of personality has grown up around him.
But Forde and Millea emphatically deny any suggestion of cultish characteristics. "We are a business operating a service. We reject that allegation entirely. As for the interview with Tony, we like people to know where Tony is, what he`s doing, what approach he`s taking and what services are operating."
To the allegation that some subscribers to Tony Quinn`s life-changing programme consider him a guru, Forde says: "People are prepared to go on seminars because they think that Tony has something to offer. You have to ask yourself what allows a person to be anaesthetised. He has a capacity for original work in the academic sense. He has a capacity to help people use their minds."
"Also," adds Millea, "a guru is one who points. He points to them."
Quinn is a master of the metaphor and we will end this article with one of his classics:
"Have you ever been interested in cracking the system - so you can live life outside of it on your own terms? My whole life, this has interested me at all levels. I have always described it as the rat in the rat race that stops and sits looking for a hole in the wall through which to escape. At first there is only the solid wall, so it just sits there, looking. Then one day the hole just appears and the rat is free."
It`s the way you tell them, Tony.
Tony Quinn`s qualifications
The walls of Quinn`s occasional residence in Ireland, a Martello tower in Malahide, are festooned with framed certificates of his myriad qualifications, 18 in all. When you look through them, many are diplomas for practices that are beyond the fringes of conventional health studies - naturopathic medicine, neuro-linguistic programming, hypnotism. However, two degrees, in particular, are used to validate and give ballast to his self-styled "new mind technology" programmes.
These days, Quinn styles himself as Dr Tony Quinn, Doctor of Clinical Hypnotherapy (DCH). Such a lofty distinction was conferred by the American Institute of Hypnotherapy (AIH), based in Santa Ana , California , which awarded most of its degrees by distance learning.
However, nowadays when you access the AIH website, you are redirected to the American Pacific University (APU) in Hawaii . When contacted, the AIH said it was not "actively encouraging" any new students in California but would be offering DCH and PhD degrees by distance learning. An APU employee told The Sunday Tribune that the PhD could be done in two years by correspondence.
Dr John Bear, based in California , is the leading authority in the US on non-traditional education, ie private degree-giving schools. His guide to non-traditional colleges (the best and worst) is in its 13th edition and has become the standard work. He has given expert evidence on behalf of the FBI in cases involving unaccredited colleges and qualifications. In the 10th edition, he described AIH thus: "Offers doctorates in hypnotherapy, entirely through correspondence study. Students are encouraged to finish their PhD in less than one year... Authorised to grant degrees by the state of California ."
In the early 1990s, the college`s own prospectus said that because continuity of learning was important, students were encouraged to complete their doctorate in clinical hypnotherapy in a year or less. The fee was $3,300.
Bear told The Sunday Tribune that state approval did not mean that a college was accredited. Approval is regulated by the Office of Consumer Protection in California . However, accreditation means recognition of the degree as a doctorate by an agency approved by the US Department of Education. Bear said that the AIH was not accredited by any agency or organisation recognised by the US Department of Education. An AIH employee confirmed that the AIH has never had accreditation.
Sean Collins of the Irish Institute for Counselling and Hypnotherapy attended the AIH in the early 1990s and also received a DCH qualification. He was living in California at the time and spent two and a half years attending courses at its campus in Santa Ana . He said that he found the course to be very beneficial. He accepts that the doctorate would not have the same status as a conventional post-graduate doctorate from an established university. "It is a non-traditional route," he says. "It was the only place at that time that was offering training in hypnotherapy. I accept that it`s not a Trinity College PhD or an Oxford PhD. I must point out that the standard of lecturing was very high."
The other qualification that Quinn most proudly advertises is a Masters of Science Degree from the University of East London (UEL), which he was awarded in 1995. However, he claims that it is an MSc in clinical psychotherapy. According to the UEL, it is an MSc by independent study. His thesis was entitled "An Investigation into the Hypnotic Effects of Hypnotic communication on the Individual’s Subjective Experience of Pain". Quinn`s research involved the hypnosis of four patients undergoing elective, and minor, surgery (a video of the operations was shown on The Late Late Show).
Quinn makes extraordinary claims about the qualification and its significance to the pool of learning. In the latest Blueprint, he has this to say. `Working with a university, I discovered what has now become known as unconscious attention. For this I received a master of science degree, the highest award to date for original research in the area of "how to use more of your brain and mind" Unconscious attention proved to be THE breakthrough and has since played the key role in all of my work.`
A spokeswoman for UEL said that it would be impossible to comment on his claim without revisiting his thesis. However, she pointed out that the claims were stated in the passive voice (without reference to who considered it to be THE breakthrough) and seemed to be his own interpretation of the significance of the degree.
There is no reference to unconscious attention in the thesis title. Martin Forde, a spokesman for Tony Quinn, explains that for academic reasons the title of the thesis was confined to hypnosis. (Incidentally, the use of hypnosis in surgical procedures is nothing new - it was used extensively until it was superceded by anaesthetics.) There is some confusion as to what comprised Quinn`s research for the thesis. He has stated more than once that the operations were part of his research for the MSc. However, Forde now says that the operations formed part of research work undertaken after Quinn had completed his masters.
Quinn continues to work with a university (presumably the UEL) on "ground-breaking research which is causing quite a stir in scientific circles". In one study, sales revenue increased by 70% in a company when sales staff used unconscious attention. The results were monitored by Price Waterhouse.The company which achieved this amazing result was, in fact, Quinn`s own health stores, selling Quinn`s own health products. Hardly objective research.
Forde responds: "Tony had not been involved with the companies for some years. We had taken on new staff as well as old staff. There were about 20 new staff. It was with those staff that the great leap forward was made." Forde also said that Quinn was currently working towards a PhD.
The Educo System
and what the experts think of it
"Simplistic in the extreme and without any acceptable research," is how one of Ireland`s leading academic psychologists, Professor Ciaran Benson, describes Tony Quinn`s Educo "breakthrough", developed in the early 1990s. For most of his life, Quinn says he had "researched the mind". Somewhere along the way, eureka!, Educo was born.
Quinn sets out his stall for it in an extraordinary 1993 tape, a mishmash of metaphors and "insight" that spends almost two hours explaining his "new mind technology".
The formula that underlies Quinn`s Educo system is set out in a mantra: "If you want something believe that you have it without any inner doubt and it will come about."
One piece of research that is repeated ad nauseam is that humans use less than 10% of the mind – "now it`s sometimes said to be as little as 1-3%", Quinn states confidently. He claims he can tap into the unconscious. Likening the mind to a computer, he says our true selves have been ruined by thought programmes. "To the self, thoughts can be added and subtracted. Thoughts can be in the form of education, experience, conditioning. They can be beliefs, worries, phobias, creeds, complexes, etc. These solidify into what we call our personality... This programmed personality is not yourself."
Quinn`s solution is that we step out of thoughts, "anti-life programmes" as he calls them, and install new programmes instead. If you can get your whole mind to accept a goal that you have, he says, then it will come about effortlessly. You get into a state of "unconscious attention" where everything is effortless and you can be 100 times more aware than ever before; you can then "photograph" your goal or install a new programme (frequently expressed in terms of riches and material success) and you will instinctively follow that goal like a heat-seeking missile.
Benson, the head of the psychology department in University College Dublin, was already familiar with Tony Quinn`s philosophies before he was approached by this newspaper and had this to say after perusing extensive material on Quinn`s Educo system, including the Educo tapes. "I have read all the documentation supplied by you and on foot of it, whatever persuasiveness Mr Quinn has, it has nothing to do with his grasp of psychology. I found it simplistic in the extreme and without any acceptable research support."
He continued: "If he is persuasive with some types of people, it is a persuasiveness which seems to be based on identifying such people’s needs and distresses rather than on any scientific or theoretical understanding of contemporary human psychology. He purports to give people an understanding that he has developed on the basis of research that he has been conducting for most of his adult life. Nothing of what I have read shows anything other than the most banal and superficial understanding of psychology or of other human beings."
He describes Quinn`s theories as primitive. "His use of key concepts such as self and mind is extraordinarily primitive and confused. His metaphors such as `thought programmes` are very misleading. They obscure more than they reveal. In his talk, he moves from one crude metaphor to another. These metaphors have no defensible relationship to a scientific or philosophical understanding of human psychology," he says.
Some of the psychological propositions and research that Quinn uses simply do not stand up to scientific scrutiny, according to both Benson and Professor Ian Robertson, head of the psychology department in Trinity College , Dublin , and the director of the Trinity College Institute of Neuroscience. Robertson had not heard of Quinn before The Sunday Tribune approached him and had never seen any of his materials. He answered specific questions that were put to him about the brain without knowledge of, or reference to, Quinn`s claims or activities.
To the notion that humans use less than 10% of their minds, he had this to say: "This idea that we only use 10% of our minds is a modern myth without any scientific foundation. There are no areas of brain tissue that are lying dormant, waiting to be awakened. There are no magic bullets here."
Asked about research that Quinn claims shows the unconscious to be a site of a far larger portion of mental life than Freud ever envisaged, Robertson said this proposition could not be substantiated. "Much of our brain`s activity goes on outside of consciousness and we can be influenced by events and stimuli of which we are not aware. The nature of this unconscious activity studied by experimental psychologists is, however, quite different from Freud`s notion of the unconscious and there is no evidence that it is greater in scope."
Another piece of research, quoted by a tutor at Quinn courses, is a study said to have been carried out in an old person`s home that showed that the majority of people who were senile had been exposed to people who were senile when they were children. The children unconsciously "photographed" the memory which became a blueprint that continued into old age. The basis for this, according to Quinn, is a study called Mindfullness carried out by Ellen Langer at Harvard and Yale universities.
However, Robertson refutes this. "Senility is a layman`s term for a range of brain diseases that are determined by molecular changes in the brain and could not be affected by early exposure to people with dementia. There is no scientific basis for such a statement," he said.
In the latest Blueprint for Living, Quinn says that he can help people become two or three times more aware than they normally are. Benson says that this is ridiculous. "In psychology you can rarely say that any capacity is two or more times as much as some other capacity. To make such statements presupposes being able to specify what zero capacity is. It is in the nature of most psychological functioning that this cannot be done. To claim to be able to do so is either to betray a profound ignorance about the use of numbers in psychological research or to deliberately mislead."
Quinn also operates an extremely profitable postal requests system that is linked to Educo. His literature says that the Educo system can be used to obtain results in every aspects of a person`s life from business, health, healing, success to self and life improvement, and can even be used to achieve results for people who are not aware that they are the subject of a request.
The postal requests have to be accompanied by a cheque for £25, or £40 for a family, and have to be renewed monthly. Quinn invites people to write down their goals and to send them in with a photograph. Alternatively, you can ring them in. He and a long-time Quinn associate, Aideen Cowman, promise to apply their minds for the desired outcome.
"Often I find I receive requests for third parties who don`t know of the request, yet it still works," Quinn has said of the system. "In fact, if the request seems impossible, like a terminal illness, then I always advocate third parties making a request not to tell the person concerned in case they include my prayer in their anti-life thought programmes. I truly feel that it is better if they don`t know and it increases the chances of a positive outcome.
“When I put my hands together and I really believe wholeheartedly in truth, effortlessly expecting a result, I notice that a feeling of energy comes from inside me, runs down my hands and into the request. I really do feel like that magician pouring that magic energy into those requests."
Asked could the human mind work in such an extraordinary telepathic capacity, Robertson simply replied "No".
Martin Forde says that postal requests involve Quinn working in conjunction with the requester but agreed that when a person was seriously ill, they were passive. He said that these things were the subject of much research, which would substantiate the practice. He also said that Tony Quinn absolutely stands over everything he says and is in a position to back it up.
Quinn "spoke with voice of Jesus"
Film director Jim Sheridan was "unnerved" by meeting, write Richard Oakley and Harry McGee
Award-winning film director Jim Sheridan has claimed that controversial lifestyle guru Tony Quinn told him that he once had a vision in which the voice of Jesus was coming from inside him.
In an interview with The Sunday Tribune, the director of Oscar-winning movies such as My Left Foot and In the Name of the Father said Quinn approached him two years ago through a mutual friend who was involved with Quinn`s organisation.
Quinn, according to Sheridan, wanted to make a film about a hypnotist. They met in the Malahide home of the figurehead of the positive living group, whose activities have led to concern among the families of some of those involved.
"I had met him before and I was once interviewed for his newspaper. I agreed to meet him because a friend of mine asked me to. He started telling me all about himself and the idea for a film he had about a hypnotist."
"He was telling me all sorts of stuff about himself, some of which I couldn`t believe. He told me he was walking along one day when all of a sudden a group of some sort of Middle Eastern people appeared to him.
"He said he became aware that he was walking on sand and he followed the people to the top of a hill. He said there were thousands of people there and that he thought he heard Jesus speaking to them, but then he realised it was him. That is verbatim what he told me. I found the whole meeting unnerving."
The Sunday Tribune asked representatives of the Tony Quinn organisation if the event occurred. Tony Quinn was uncontactable but a spokesman spoke to someone who was present at the meeting. He confirmed that Quinn had an idea about a film and described it as a "sci-fi" one. However, he denied that Quinn referred to himself as a Jesus-type figure or told the story recalled by Sheridan .
Dublin-born Quinn is now a multi-millionaire thanks to his £15,000 "life-changing" seminars. Some of Quinn`s own clients told RTE`s Liveline programme last week that Quinn had similarities to Jesus.
However, this claim has been denied by Quinn`s organisation. "Tony Quinn does not have an identity crisis. He does not think he is the reincarnation of Jesus Christ," the spokesman said.
Sheridan said yesterday that after the meeting he made it clear that he did not want to have anything to do with Quinn. He said he was approached again about the project but that he refused to get involved.
News Focus,
Pages 14-15
THE MIGHT OF QUINN
Relatives of those who have become committed to Tony Quinn describe how it has affected their lives.
It was the last day of one of Tony Quinn`s £15,000 seminars. The exotic location this time was Paradise Island in the Bahamas , where Quinn has lived for the past five years. There were about 20 people on this particular trip, less than the usual attendance. Some have had up to 50 people attending, such as the one in Monte Carlo last year. As a special treat, the group was brought on a bus to Quinn`s residence, a sumptuous building with its own private beach, two swimming pools, and a garden stretching across many acres. It is worth many millions of dollars, according to a former associate of Quinn.
However, the group wasn`t allowed across the threshold of the great man`s house, but had to be content with being entertained on the patio. No one could go beyond the hall door, it was explained, because in the past people had pocketed items from the house to keep as mementoes or souvenirs of Quinn, relics of the true cross, as it were. There was, however, a consolation prize. Quinn posed for photographs with the group and then autographed cards for them, some of which bore a portrait of him in white-toothed Cheshire Cat mode.
"Your new life starts here," he wrote on the cards. "Lots of Love, Tony xxx xxxx."
A seminar with a tea party on a patio as the grand finale - accompanied by a card with seven kisses on it - might seem a pretty paltry return for doling out 15 grand, but for Tony Quinn followers, it`s more than enough. For many, even a few seconds with Quinn himself counts as an out-of-body experience. Quinn, as The Sunday Tribune has discovered, is believed to be the next best thing to God by some of his followers and, quite possibly, by himself. Some say he shares similarities with Jesus. Such a view was expressed on RTE Radio`s Liveline last week during a discussion on Quinn prompted by the first part of this Sunday Tribune investigation.
Others describe him as a genius. One of his closest associates, Colette Millea, told this newspaper he is a genius whose achievements, like others who have gone before him, will not be fully recognised in his own lifetime.
Whatever way they see him, however, one thing is certainly true - most of Quinn`s followers are extremely loyal to the man who promises them he can change their lives, even though all the evidence shows that he is not all he claims to be. While people would claim to have benefited from any involvement with Quinn, The Sunday Tribune has spoken to others whose lives have been turned upside down by what they see as his organisation`s less-than benign influence on their loved ones. They say that relationships have been fractured and people distanced from their families because of their involvement with Tony Quinn. And there are others who are opposed to what Quinn is doing. A number of former followers are disillusioned with the organisation`s relentless pursuit of profit.
In the most detailed exploration of Quinn`s background and way of thinking, which includes extraordinary details never before examined, it can be seen that there is a heavy dependency culture among some of those involved and, in a number of cases, their entire lives seem to revolve around Quinn.
Very few people are prepared to speak out against Quinn. Those who do will generally ask for their identity to be protected. Some do not want the Quinn organisation to know that they have a problem with it. Others do not want their relatives, who are involved in the organisation, to know that they are opposed to what they are doing.
Gerry Murphy, a GAA employee, is one of the few people prepared to speak publicly about the Quinn organisation. Neither Murphy nor his wife had ever heard of Tony Quinn until he became ill and was told by a surgeon that he would have to start looking after himself properly. "The first time I had ever heard of Tony Quinn was when we visited one of his health stores in Carrickmacross. I took home some of his supplements and started a new diet. After about a week I didn`t feel any better so I decided the diet was useless. I told my wife, stopped using the supplements and my direct involvement with the Tony Quinn organisation ended there. Hers, however, was only starting."
Murphy`s wife started to attend Quinn`s classes. Within a short time, she began working for Quinn, using his products and believing strongly in his philosophy.
"Over the first two or three years, she changed in personality and in attitude. She became totally different to the woman I had married. Her whole life was dominated by Tony Quinn. She spent every spare moment working for Quinn at the expense of her family and friends. I wouldn`t see her from one end of the week to the other. She attended every seminar and travelled to Dublin all the time. In one six-month period, she clocked up 32,000 miles on the car. At the same time I noticed that no matter how much money we made, we never had any and I came to realise that the reason for this was she was spending huge amounts on Tony Quinn-related things," he says.
Murphy said the problem came to a head when he decided that he could no longer cope with his wife`s involvement with Quinn. He tried to stop her attending a seminar and in the ensuing argument asked her to choose between the Quinn organisation or him. "It was Friday, 26 June 1992 and at 6pm she walked out the door on her entire life and within two hours was in Tony Quinn`s house in Malahide," he said.
Murphy believes his wife is still involved in the Tony Quinn organisation. They are now legally separated. He has spent the last nine years trying to understand what happened and cannot come to terms with the level of loyalty his wife showed to the Quinn organisation or the level of control the organisation seemed to have over her. In that time, he has campaigned against what he believes is a harmful organisation and believes there needs to be government regulation of organisations like Quinn`s.
Murphy is not the only person who believes this. Two people whom we shall call Paul and Ann say that they have lost their partners to the Tony Quinn way of life and both tell very similar stories. Neither of the two will go on record about their experiences as their loved ones are still involved in the Quinn organisation - when they were interviewed for TV3, with whom this newspaper`s investigation was carried out, they both appeared in silhouette.
Paul`s wife has been involved in the Tony Quinn organisation for 10 years. The last four have been very problematic and his marriage has recently broken up. "Initially, when she became involved I had no problem with any of the activities, the gym, the healthy eating, the exercise. However, my concern developed over the years, when I came to understand more about Tony Quinn`s life-system and her involvement increased. At one stage, my wife, without discussing it with me, decided to leave her job to go to work for the Tony Quinn organisation. The move entailed a 50% drop in salary which just didn`t add up."
He said his wife changed dramatically from this point on. "My wife became totally dependent on all Tony Quinn things and she became what I can only describe as de-personalised. It got to a stage where she would get up in the morning and take six or seven Tony Quinn supplements, listen to Tony Quinn tapes throughout the day, wear Tony Quinn t-shirts and use Tony Quinn shampoo. She would keep turning off the news because she had been told not to listen to negative information"
He explains that this dependence is part of the reason his marriage broke up. "Eventually, I asked her to make a choice either to take a break from Tony Quinn or risk ending our marriage. She said she would rather end the marriage than take a break."
He denies that the break-up resulted from problems in his relationship that had nothing to do with Quinn. "There definitely was a total dependency. I know you can say that all husband and wives argue, and that is fair enough, but the Tony Quinn lifestyle also came between my wife and her family."
Ann`s husband is a wealthy businessman who attended one of the £100,000 one-on-one courses with Quinn. She had never heard of Quinn but since her husband went on the seminar, she has been fighting to prevent other members of her family being recruited to the Quinn system. "When my husband returned from the seminar, he was very much unrecognisable from the man I married. He was emotionally withdrawn from both myself and the children. The changes in him had a major effect, our marriage broke up and the children were devastated."
She said he seemed not to have control over his own mind. "I don`t know if I will ever get my husband back to his normal self. I am working very hard at it and I think I will eventually convince him to leave the Quinn organisation, because he does listen to me. At the moment, though, he is carried away on something that he has no control over."
As well as Murphy, Paul and Ann, The Sunday Tribune also spoke to six other families, all of whom had similar stories to tell. One mother said her daughter changed for the worse after she went to a seminar and the problems this caused have devastated her family. Another woman, from a farming background, said her husband recently received a large amount of money in compensation and that he spent £15,000 to go on a course in Egypt . Her family is distraught about the changes they have seen in him and she said her marriage is now destroyed.
In response, however, representatives of the Tony Quinn organisation, Martin Forde and Colette Millea, say that the instances in question were unfortunate, but denied that Quinn`s system was to blame. They say marriage break-ups are a part of life and that their courses have been attended by numerous couples who have stayed together. "We expect from the training people receive that changes can happen to their levels of awareness. I am very sorry to hear that families can be unhappy with it. However, there are at least 50 examples where one member of a marriage has sent the other out on seminars. They are all very happy with what has happened for them," Forde said.
Like the couples who the Tony Quinn organisation states are happy with the product on offer, there are plenty of single people who also find the Quinn life system to be of value. A large number of people use Quinn products, attend his courses or his gym and would say they have benefited greatly from the experience. "If I was to put a figure on it, the number of people unsatisfied it would be way less than 1%,"Forde said.
Shane Cradock, for example, is a chartered engineer. He said he went on a Quinn seminar in 1998 and found it "very helpful". Since then he has left his job and set up a business of his own. He still attends Quinn courses regularly, he believes he now has more control over his life and, he said, his health has radically improved.
John O`Doherty owns a steel company. Both he and his wife have been on Quinn seminars. Since he went, he said, his business has trebled because he has been able to work to his full potential. He claims only a proportion of what he has achieved would have been possible if he had not gone on Quinn`s seminar.
On Wednesday of last week, three women, all of whom had gone on Tony Quinn seminars, were featured on Liveline. Catherine, Barbara and Simone all said that going on the course was one of the best things they had ever done.
"I saw the £15,000 as an investment. My story is a very positive one. I invested in my own personal development and I got a fantastic return from the seminar. I am involved in sales and I found it brilliant. You go on the seminar for the information, it is stand-alone information," said Barbara. "I have to pinch myself in the morning - that is how good things are for me."
"An enigmatic character with huge powers of persuasion and influence"
Though his organisation purports to be nothing other than a business, there is much evidence, not least from Quinn himself, showing how it operates as a cult
There are aspects of Tony Quinn`s organisation that certainly appear to have more than a passing resemblance to those of a cult. And the more you delve into how he managed to build it into what it is today, the more similarities emerge. It is clear that he himself has grappled with this question. In an extraordinary tape never publicly revealed before, but a transcript of which has been obtained by this newspaper, Quinn tells those attending a seminar in 1994 about how he sees himself and in the process poses the central question.
"You might say, Am I trying to start a cult, am I trying to be a leader of something?" I don`t know. But if you have any suspicions about me, the beauty of it is that you are totally safe and you won`t line up with me anyway.
Mike Garde, a field worker with Dialogue Ireland , an independent group which monitors religions and cults, believes the Quinn organisation is a cult and says Quinn himself shares similarities with other cult leaders.
According to Garde, the aspects of the Quinn organisation which share similarities with a cult are its strong figurehead, the elimination of opposing thought, the unswerving loyalty of enthusiasts to Quinn, and the view that those who criticise Quinn do not fully understand and their objections should be discarded.
Spokespeople for Quinn`s organisation vehemently deny this, pointing out that it is a business offering a service which people can take or leave. They say that Quinn`s image is used to promote products and services that he originated. They particularly object to the use of the word "organisation" because of any connotations it may suggest.
Quinn`s detractors believe, however, that he has a strong messianic streak and that his personality dominates the lives of some of those who subscribe to his Educo mind-technology. The 1994 seminar espoused a philosophy that needs those who adhere to submit themselves totally to Quinn and align themselves to the force that Quinn claims exists within him.
The seminar is littered with religious metaphors and concludes that only submission works. "If you were to relate to me, by that I mean give up all your resistance, give up all your ideas that are in the way and align yourself to me, then I can bring out all the Self and put in a programme that you and I believe was best for you and give you this perfect life," says Quinn.
Later, he says: "Something in them, which I believe is their force, recognises the force in me and they instantly, quite frankly, would do anything that I told them and there is no problem."
Quinn refers to himself in terms of being a leader of some kind of movement, all aligned to the internal force which he has discovered. "I think that in some way I am meant to work with a large group of people - it could be millions." He speaks of how the force has made him into a healer, capable of making others into healers. "If I can line up enough people with me and keep it pure, I can change the world," he promises.
However, there was some levity. He came across, he says, as a " Dublin fellow who comes from Ireland , is a bit of a peasant, a bit of a thicko, says silly things, does silly things and has these childish hobbies where he believes that he must be faithful to his heroes".
His spokesman Martin Forde rejects that there is any element of proselytising in Quinn`s message or in the methods in which his Educo system is sold. But it`s clear Quinn claims a greater role for himself than the mere jawboning of business gurus who goad you to even greater selling techniques.
"This brings me back to whether I would see myself as some type of leader. There, I would say that my answer is yes. I have always felt that in some way I would be involved in great change in the world."
In 1972, when he was bringing yoga to the masses, Quinn had already assembled a loyal core of followers, some of whom have remained faithful to him to this day. He set up communes in suburban homes in Kilbarrack and Howth, where people could step outside ordinary existence and experience yogic states of being - the different states of existence, past lives, auras and karmas. Two people who were heavily involved with Quinn in those early days say that there was a messianic aspect to him, that some believed he was a reincarnated Jesus. Certainly, it is clear that he spawned a loyalty that bordered on devotion. Quinn enthusiasts nowadays often drive Japanese sportscars on the basis that Tony likes sportscars; they put a huge emphasis on the body beautiful (Quinn is a body-building enthusiast); and use the full range of Quinn food supplements and vitamins. There also seems to be a predilection for a certain type of look with Quinn enthusiasts - one former employee described what she saw as the "women in black" phenomenon, whereby some women involved with the organisation wore black clothes, a lot of make-up, and short skirts.
The loyalty has extended to being involved in many of his research "breakthroughs" – "working under strict university conditions". Three of the four patients who underwent operations without anaesthetic - one of the marketing bulwarks for Educo and described as "unremarkable" by experts - were employees of Quinn they included Colette Millea, and Imelda Farrell who runs the Tony Quinn Health Centre in Cork . The research "breakthroughs" involving dramatic improvement in sales were achieved in Quinn shops with Quinn employees. Some of the "before" and "after" pictures used to publicise his gyms and slimming products also use Quinn employees, such as Maire Lalor, an Educo seminar tutor.
The Sunday Tribune has spoken to six people who were involved with the Quinn organisation, some for protracted periods. All spoke on the basis that their anonymity would be guaranteed. All describe Quinn as an enigmatic character with huge powers of persuasion and influence. Some attributed it to a nebulous form of psychic powers, others to an ability to relentlessly focus on people, others to his ability to hypnotise. "I definitely believe he has a psychic power, a hold over people," said one, who was deeply involved with Quinn in the 1970s.
Quinn himself variously describes this power as a force, an energy, a healing power. "I noticed... that this force seemed to touch off some people and cause great changes in their lives," he says during a seminar in 1994. "I used to find that people might literally fall down and when they got up again they felt that they had an understanding, an awareness, an experience that was greater than anything that happened to them before and it changed their lives. It was as if their personality was overcome by this force."
On his Educo tape, he explains the effect that he has on the people at his seminars. "People speak of happiness, even euphoria, with their minds feeling crystal clear. People often talk about a brightness in their head. Some claim they get an increase in energy, that it feels like energy circulating through their body and going out to other people."
The thrust of one of Quinn`s 1994 seminars is submission to him and obeying the force – "lining themselves up" with the force that emanates from Quinn. Independent thinkers need not apply and it`s clear that the great man isn`t a fan of feminism.
"With fellows, they may want to be very egotistical with me. In other words, they want to be better than I am and once they are into that mode it won`t work because they are making great effort. I may sit down with girls and they are into something like women`s lib and again we are into problems. I reject all these things. I will shock you because sometimes I say to people, `Do what I tell you and if you don`t know what it is, ask me`. What I tell people is, `just line yourself up to me`."
There is no shortage of newcomers prepared to align themselves to Quinn, as testified by the numbers attending his seminars. However, some of the families of these people are concerned that the changes have adversely affected their relationships with spouses and families. These people firmly believe that Quinn`s organisation has had a cult-like draw on their families, which has caused a rift between them and their loved ones.
A former associate says: ÒI spent most of my adult life with Tony Quinn, believed everything that he said. Tony Quinn was my entire life. But Tony was obsessed with money and very few others within the organisation made any real money at all. They were collecting huge amounts of money from the postal requests, the health products, the gyms and the seminars, but very little of it was filtering down. Nobody ever questioned him.
"When I left, the shutters came down. I was excluded. You were either with Tony or you were completely out in the cold. That`s what happened to me."
Two others spoke about how they became personae non grata with the organisation once they had left, or were asked to leave. One expressed doubts about the necessity of selling seminars at £15,000 and was asked to leave shortly afterwards. Quinn, in his 1994 seminar, explicitly states that those whom he works with must align themselves to him and the force to which he speaks directly. In the mid-1990s, people who had lived in a communal house owned by Quinn for 20 years were asked to leave both the house and the Quinn organisation - some were said not to have wholeheartedly embraced Quinn`s relatively new departure into the Educo system.
"I am totally convinced that is the real problem that happened even in the organisation I was with - that people did not fully accept what I am outlining to you here. I am moving away from that at this stage. I don`t want to do this, but I feel that I must just work with whoever totally accepts what I call the Educo philosophy."
Friday, February 23, 2007
Thursday, February 22, 2007
INSIDE POLITICS - Outside the cocoon, inside the cocoon
I drove down to Connemara from Dublin yesterday to appear as a guest on TG4's 'Seacht Lá'.
Even when driving through the Irish countryside, you can't really escape politics.
First, there was the road. The N4 extension brings you as far as Tyrrellspass in Co Westmeath now. As you go back onto bockety roads, you can see that the work is well advanced to take the road beyond Kilbeggan and Moate and all the way into Athlone.
As sure as night follows day, a good portion of that road will be open by the time the General election takes place.
(As an aside, it looks like it will happen on May 18th, a Friday. Michael McDowell twice referred to 90 days being left at his party's conference last weekend. It is also roughly the same time as the election five years ago.)
There can be no more visible and tangible evidence than progress or achievement than the smooth tarmacaddam of a wide metalled road. Expect a lot more openings over the next three months - some of them for blatant electioneering purposes. Look at the speeches of FF and the PDs - if there's money in muck, there are votes in roads.
The second unavoidable feature of the journey west was the spate of pre-election posters. Now, it's illegal to start plastering the country with smiling politicians' faces before the official campaign gets underway.
But what some have done is paid for very expensive billboard space or used other innovative ways. There's a huge poster of Mary O'Rourke, looking menacing enough to be a sentienl for the west of Wetmeath, on the approach to Kilbeggan. I'm not sure if it was a reminder to voters or a warning to Donie Cassidy to stay out!.
Further west nearer Athlone, the Fine Gael candidate Nicky McFadden's campaign van was prominently parked for the night on the N6. Maybe it was happenstance, but there was no lack of visibility.
And then in Galway East, Fine Gael's new candidate Dr John Barton has made his presence felt. The Ballinasloe-based specialist is likely to pose a threat, not only to Paddy McHugh but also to his running mate Senator Ulick Burke.
I spotted three of his billboards near the main road west, in addition to the very prominent signage of his office in the centre of Ballinasloe.
They keep on telling us that the campaign hasn't started in earnest yet. But nobody seems to be listening.
Even when driving through the Irish countryside, you can't really escape politics.
First, there was the road. The N4 extension brings you as far as Tyrrellspass in Co Westmeath now. As you go back onto bockety roads, you can see that the work is well advanced to take the road beyond Kilbeggan and Moate and all the way into Athlone.
As sure as night follows day, a good portion of that road will be open by the time the General election takes place.
(As an aside, it looks like it will happen on May 18th, a Friday. Michael McDowell twice referred to 90 days being left at his party's conference last weekend. It is also roughly the same time as the election five years ago.)
There can be no more visible and tangible evidence than progress or achievement than the smooth tarmacaddam of a wide metalled road. Expect a lot more openings over the next three months - some of them for blatant electioneering purposes. Look at the speeches of FF and the PDs - if there's money in muck, there are votes in roads.
The second unavoidable feature of the journey west was the spate of pre-election posters. Now, it's illegal to start plastering the country with smiling politicians' faces before the official campaign gets underway.
But what some have done is paid for very expensive billboard space or used other innovative ways. There's a huge poster of Mary O'Rourke, looking menacing enough to be a sentienl for the west of Wetmeath, on the approach to Kilbeggan. I'm not sure if it was a reminder to voters or a warning to Donie Cassidy to stay out!.
Further west nearer Athlone, the Fine Gael candidate Nicky McFadden's campaign van was prominently parked for the night on the N6. Maybe it was happenstance, but there was no lack of visibility.
And then in Galway East, Fine Gael's new candidate Dr John Barton has made his presence felt. The Ballinasloe-based specialist is likely to pose a threat, not only to Paddy McHugh but also to his running mate Senator Ulick Burke.
I spotted three of his billboards near the main road west, in addition to the very prominent signage of his office in the centre of Ballinasloe.
They keep on telling us that the campaign hasn't started in earnest yet. But nobody seems to be listening.
Wednesday, February 21, 2007
FROM SLATE.COM - BE WARY OF SOME SOURCES
Media criticism.
The BALCO MessOr travels in the gray areas of the confidential source arrangement.
By Jack Shafer
Posted Tuesday, Feb. 20, 2007, at 11:30 PM ET
When a reporter lies down with confidential sources, he should be prepared to get up with prosecutorial fleas, as San Francisco Chronicle reporters Lance Williams and Mark Fainaru-Wada learned the hard way in reporting the BALCO steroid and performance-enhancing drugs case.
About two years ago, federal investigators launched a search for the confidential source who broke the law by giving Williams and Fainaru-Wada access to grand jury documents from the BALCO investigation. The reporters' Chronicle stories quoted the testimony of MLB players Jason Giambi, Barry Bonds, and Gary Sheffield, among others, about steroid and drug use by pro athletes.
The Chronicle duo refused to answer grand jury questions about their sources, and were bound for jail on contempt charges when the feds finally found the leaker last week: It was Troy Ellerman, who had worked as a defense attorney for BALCO executives. Ellerman admitted leaking the transcripts, and plead guilty to four felony counts of obstruction of justice and disobeying court orders. He faces up to two years in prison and a fine of $250,000.
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Back in 2004, after the Chronicle published the leaks, Ellerman told the New York Times this whopper—"The jury pool has been infected, and our right to fair trial has been jeopardized"—as he proceeded to file a motion with the court to dismiss the case against a BALCO client, claiming that the Chronicle disclosures compromised his client's right to a fair trial!
Having found their leaker, the feds dropped the subpoena against the reporters. But a number of journalists, lawyers, and ethicists in the First Amendment Industrial Complex weren't happy to learn that Williams and Fainaru-Ward weren't the free-speech martyrs they imagined them to be.
When the Chronicle reporters used Ellerman by publishing his leaks, that was okay with the FAIC. It's FAIC dogma that it's okay in principle for journalists to publish information of vital public concern that other people have broken the law to obtain or share. Many of the most important leaks in journalistic history have required a source to break some law: Daniel Ellsberg's delivery of the classified Pentagon papers to the press, or Mark "Deep Throat" Felt's leaks to Bob Woodward during Watergate, or even the leaks of classified information about domestic surveillance by the NSA to the New York Times' James Risen.
What really ticked the FAIC off was that Ellerman had used the Chronicle reporters—by filing his deceitful motion to dismiss—and they did nothing to stop him or to inform the public of the deceit. And what really set the FAIC teapot boiling was that after Ellerman filed his motion, Fainaru-Wada visited Ellerman's office one more time to collect additional grand jury tidbits. Yes, the Chronicle used Ellerman after Ellerman used the Chronicle after the Chronicle used Ellerman.
Among the most furious in the FAIC was Tim Rutten of the Los Angeles Times, who came on like a hanging judge in his column last week, scorching the Chronicle for its conduct. He writes:
To assert any form of journalistic privilege in a situation like that is something far worse than moral obtuseness. Conspiring with somebody you know is actively perverting the administration of justice to your mutual advantage is a betrayal of the public interest whose protection is the only basis on which journalistic privilege of any sort has a right to assert itself.
Obviously, Williams and Fainaru-Wada should have dusted themselves with something stronger than flea powder before snuggling up with Ellerman. As experienced reporters, they knew that most leakers arrive on the scene with their own agendas. They are not angels, either. A defense attorney leaking grand jury testimony is suspicious, but one filing motions to dismiss based on his own leaks is absolutely dangerous.
That Ellerman was a special kind of sleaze surely occurred to the Chronicle reporters upon first meeting. I'm sure they regarded him as a treacherous force, but one whose perfidy served their ends, and that those ends advanced the common good as they understood it—i.e., they had a duty to inform the public of the illegal use of drugs in sports and of the many lies told by the athletes and their employers on the subject.
Under the sketchy rules that govern leaks to reporters, Ellerman had every "right" to deny that he was the source of the leak without having the Chronicle publicly contradict him. Some would say that he was within his rights to blame others—including the prosecutors—for his leak without risking exposure by the Chron. But I get a little woozy at the notion that Ellerman's "deal" might have included the right to break additional laws that the Chronicle must ignore. Indeed, by viewing additional grand jury documents after Ellerman filed his motion, Fainaru-Wada almost seems to be sanctioning the lawyer's blatantly illegal motion.
There is a school of thought that says as long as Ellerman didn't give the Chronicle any bad information he upheld his side of the bargain, and that's that. Law professor Alexander M. Bickel, who represented the New York Times in the Pentagon Papers case, veers in this direction. In his much cited book The Morality of Consent, he holds that journalists shouldn't over-worry about their source's motives, writing that "the presumptive duty of the press is to publish, not to guard security or to be concerned with the morals of its sources." What matters first is the quality of the information reporters produce. "[T]he weight of the First Amendment is on the reporter's side, because the assumption underlying the First Amendment is that secrecy and the control of news are all too inviting, all too easily achieved, and, in general, all too undesirable," he continues.
Not knowing the inside story, I won't rush to judge the Chronicle's recent travels in the gray area of confidential source arrangements. But I do have a few questions for the paper. When—if ever—did it part ways with Ellerman? Does the Chronicle regret having quoted so faithfully from grand jury transcripts? Was it trying to bait prosecutors into subpoenaing its reporters? That's how it looks from a distance. Does it regret the last taste it took of the transcripts? Why didn't the paper do a better job in preparing the public for the Ellerman bombshell? During its long legal fight to keep its reporters out of jail for refusing the grand jury subpoenas, the Chronicle gave no indication of its morally ambiguous relationship with Ellerman. It was all "rah-rah-rah" for the First Amendment. Are all legal clashes about confidential sources imbued with moral ambiguity, and that critics who guess otherwise ?
Finally, we journalists always talk about the "chilling effect" when a reporter is threatened with jail. How come nobody is talking about the "chilling effect" of the BALCO source going to jail? As the next reporter you talk to whether the resolution of the BALCO leak investigation is going to make it harder for the press to cultivate confidential sources.
The BALCO MessOr travels in the gray areas of the confidential source arrangement.
By Jack Shafer
Posted Tuesday, Feb. 20, 2007, at 11:30 PM ET
When a reporter lies down with confidential sources, he should be prepared to get up with prosecutorial fleas, as San Francisco Chronicle reporters Lance Williams and Mark Fainaru-Wada learned the hard way in reporting the BALCO steroid and performance-enhancing drugs case.
About two years ago, federal investigators launched a search for the confidential source who broke the law by giving Williams and Fainaru-Wada access to grand jury documents from the BALCO investigation. The reporters' Chronicle stories quoted the testimony of MLB players Jason Giambi, Barry Bonds, and Gary Sheffield, among others, about steroid and drug use by pro athletes.
The Chronicle duo refused to answer grand jury questions about their sources, and were bound for jail on contempt charges when the feds finally found the leaker last week: It was Troy Ellerman, who had worked as a defense attorney for BALCO executives. Ellerman admitted leaking the transcripts, and plead guilty to four felony counts of obstruction of justice and disobeying court orders. He faces up to two years in prison and a fine of $250,000.
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Back in 2004, after the Chronicle published the leaks, Ellerman told the New York Times this whopper—"The jury pool has been infected, and our right to fair trial has been jeopardized"—as he proceeded to file a motion with the court to dismiss the case against a BALCO client, claiming that the Chronicle disclosures compromised his client's right to a fair trial!
Having found their leaker, the feds dropped the subpoena against the reporters. But a number of journalists, lawyers, and ethicists in the First Amendment Industrial Complex weren't happy to learn that Williams and Fainaru-Ward weren't the free-speech martyrs they imagined them to be.
When the Chronicle reporters used Ellerman by publishing his leaks, that was okay with the FAIC. It's FAIC dogma that it's okay in principle for journalists to publish information of vital public concern that other people have broken the law to obtain or share. Many of the most important leaks in journalistic history have required a source to break some law: Daniel Ellsberg's delivery of the classified Pentagon papers to the press, or Mark "Deep Throat" Felt's leaks to Bob Woodward during Watergate, or even the leaks of classified information about domestic surveillance by the NSA to the New York Times' James Risen.
What really ticked the FAIC off was that Ellerman had used the Chronicle reporters—by filing his deceitful motion to dismiss—and they did nothing to stop him or to inform the public of the deceit. And what really set the FAIC teapot boiling was that after Ellerman filed his motion, Fainaru-Wada visited Ellerman's office one more time to collect additional grand jury tidbits. Yes, the Chronicle used Ellerman after Ellerman used the Chronicle after the Chronicle used Ellerman.
Among the most furious in the FAIC was Tim Rutten of the Los Angeles Times, who came on like a hanging judge in his column last week, scorching the Chronicle for its conduct. He writes:
To assert any form of journalistic privilege in a situation like that is something far worse than moral obtuseness. Conspiring with somebody you know is actively perverting the administration of justice to your mutual advantage is a betrayal of the public interest whose protection is the only basis on which journalistic privilege of any sort has a right to assert itself.
Obviously, Williams and Fainaru-Wada should have dusted themselves with something stronger than flea powder before snuggling up with Ellerman. As experienced reporters, they knew that most leakers arrive on the scene with their own agendas. They are not angels, either. A defense attorney leaking grand jury testimony is suspicious, but one filing motions to dismiss based on his own leaks is absolutely dangerous.
That Ellerman was a special kind of sleaze surely occurred to the Chronicle reporters upon first meeting. I'm sure they regarded him as a treacherous force, but one whose perfidy served their ends, and that those ends advanced the common good as they understood it—i.e., they had a duty to inform the public of the illegal use of drugs in sports and of the many lies told by the athletes and their employers on the subject.
Under the sketchy rules that govern leaks to reporters, Ellerman had every "right" to deny that he was the source of the leak without having the Chronicle publicly contradict him. Some would say that he was within his rights to blame others—including the prosecutors—for his leak without risking exposure by the Chron. But I get a little woozy at the notion that Ellerman's "deal" might have included the right to break additional laws that the Chronicle must ignore. Indeed, by viewing additional grand jury documents after Ellerman filed his motion, Fainaru-Wada almost seems to be sanctioning the lawyer's blatantly illegal motion.
There is a school of thought that says as long as Ellerman didn't give the Chronicle any bad information he upheld his side of the bargain, and that's that. Law professor Alexander M. Bickel, who represented the New York Times in the Pentagon Papers case, veers in this direction. In his much cited book The Morality of Consent, he holds that journalists shouldn't over-worry about their source's motives, writing that "the presumptive duty of the press is to publish, not to guard security or to be concerned with the morals of its sources." What matters first is the quality of the information reporters produce. "[T]he weight of the First Amendment is on the reporter's side, because the assumption underlying the First Amendment is that secrecy and the control of news are all too inviting, all too easily achieved, and, in general, all too undesirable," he continues.
Not knowing the inside story, I won't rush to judge the Chronicle's recent travels in the gray area of confidential source arrangements. But I do have a few questions for the paper. When—if ever—did it part ways with Ellerman? Does the Chronicle regret having quoted so faithfully from grand jury transcripts? Was it trying to bait prosecutors into subpoenaing its reporters? That's how it looks from a distance. Does it regret the last taste it took of the transcripts? Why didn't the paper do a better job in preparing the public for the Ellerman bombshell? During its long legal fight to keep its reporters out of jail for refusing the grand jury subpoenas, the Chronicle gave no indication of its morally ambiguous relationship with Ellerman. It was all "rah-rah-rah" for the First Amendment. Are all legal clashes about confidential sources imbued with moral ambiguity, and that critics who guess otherwise ?
Finally, we journalists always talk about the "chilling effect" when a reporter is threatened with jail. How come nobody is talking about the "chilling effect" of the BALCO source going to jail? As the next reporter you talk to whether the resolution of the BALCO leak investigation is going to make it harder for the press to cultivate confidential sources.
Sunday, February 11, 2007
A Pulitzer winning investigation
Wednesday, Dec. 20, 2000 Los Angeles Times
How a New Policy Led to Seven Deadly Drugs
Once a wary watchdog, the Food and Drug Administration set out to become a "partner" of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal.
By DAVID WILLMAN
Times Staff Writer
WASHINGTON--For most of its history, the United States Food and Drug Administration approved new prescription medicines at a grudging pace, paying daily homage to the physician's creed, "First, do no harm." Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as "partners, not adversaries."
Dr. Janet Woodcock, director of the FDA's drug-review center, says the agency depends on doctors "to take into account the risks, to read the label. ... That's why drugs are prescription drugs."
The FDA achieved its new goals, but now the human cost is becoming clear. Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.
According to "adverse-event" reports filed with the FDA, the seven drugs were cited as suspects in 1,002 deaths. Because the deaths are reported by doctors, hospitals and others on a voluntary basis, the true number of fatalities could be far higher, according to epidemiologists. An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role. But the reports are regarded by public health officials as the most reliable early warnings of danger.
The FDA's performance was tracked through an examination of thousands of pages of government documents, other data obtained under the Freedom of Information Act and interviews with more than 60 present and former agency officials.
The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for its speed than its caution. In 1988, only 4% of new drugs introduced into the world market were approved first by the FDA. In 1998, the FDA's first-in-the-world approvals spiked to 66%.
The drug companies' batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80% of the industry's applications for new products, compared with about 60% at the beginning of the decade. And the companies have prospered: The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.
Once the world's unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe. Michael Elashoff: The biostatistician was upbraided by senior FDA officials after he recommended against the approval of Relenza, a new flu drug. An agency advisory committee agreed with him, but the drug was approved by the FDA as safe and effective.
"This track record is totally unacceptable," said Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University. "The patients are the ones paying the price. They're the ones developing all the side effects, fatal and non-fatal. Someone has to speak up for them."
The FDA's faster and more lenient approach helped supply pharmacy shelves with scores of new remedies. But it has also yielded these fatal missteps, according to the documents and interviews:
* Only 10 months ago, FDA administrators dismissed one of its medical officer's emphatic warnings and approved Lotronex, a drug for treating irritable bowel syndrome. Lotronex has been linked to five deaths, the removal of a patient's colon and other bowel surgeries. It was pulled off the market on Nov. 28.
* The diet pill Redux, approved in April 1996 despite an advisory committee's vote against it, was withdrawn in September 1997 after heart-valve damage was detected in patients put on the drug. The FDA later received reports identifying Redux as a suspect in 123 deaths.
* The antibiotic Raxar was approved in November 1997 in the face of evidence that it may have caused several fatal heart-rhythm disruptions in clinical studies. FDA officials chose to exclude any mention of the deaths from the drug's label. The maker of the pill withdrew it in October 1999. Raxar was cited as a suspect in the deaths of 13 patients.
* The blood pressure medication Posicor was approved in June 1997 despite findings by FDA specialists that it might fatally disrupt heart rhythm and interact with certain other drugs, posing potentially severe risk. Posicor was withdrawn one year later; reports cited it as a suspect in 100 deaths.
* The painkiller Duract was approved in July 1997 after FDA medical officers warned repeatedly of the drug's liver toxicity. Senior officials sided with the manufacturer in softening the label's warning of the liver threat. The drug was withdrawn 11 months later. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure.
* The diabetes drug Rezulin was approved in January 1997 over a medical officer's detailed opposition and was withdrawn this March after the agency had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect in 391 deaths.
* The nighttime heartburn drug Propulsid was approved in 1993 despite evidence that it caused heart-rhythm disorders. The officials who approved the drug failed to consult the agency's own cardiac specialists about the signs of danger. The drug was taken out of pharmacies in July after scores of confirmed heart-rhythm deaths.
Overall, Propulsid has been cited as a suspect in 302 deaths. The FDA's handling of Propulsid put children at risk. The agency never warned doctors not to administer the drug to infants or other children even though eight youngsters given Propulsid in clinical studies had died. Pediatricians prescribed it widely for infants afflicted with gastric reflux, a common digestive disorder.
Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be "not approvable" for children. "We never knew that," said Jeffrey A. Englebrick, a heavy-equipment welder in Shawnee, Kan., whose 3-month-old son, Scott, died on Oct. 28, 1997, after taking Propulsid. "To me, that means they took my kid as a guinea pig to see if it would work." By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.
Questions also surround the recent approvals of other compounds that remain on the market, including a new flu drug called Relenza. In February of 1999, an FDA advisory committee concluded that Relenza had not been proved safe and effective. The agency nevertheless approved it. Following the deaths of seven patients, the FDA in January issued a "public health advisory" to doctors.
A 'Lost Compass'
A total of 10 drugs have been pulled from the market in just the past three years for safety reasons, including three pills that were approved before the shift that took hold in 1993. Never before has the FDA overseen the withdrawals of so many drugs in such a short time. More than 22 million Americans--about 10% of the nation's adult population--took those drugs.
With many of the drugs, the FDA used tiny-print warnings or recommendations in package labeling as a way to justify approvals or stave off withdrawals. In other instances, the agency has withheld safety information from labels that physicians say would call into question the use of the product.
Present and former FDA specialists said the regulatory decisions of senior officials have clashed with the agency's central obligation, under law, to "protect the public health by ensuring . . . that drugs are safe and effective."
"They've lost their compass and they forget who it is that they are ultimately serving," said Dr. Lemuel A. Moye, a University of Texas School of Public Health physician who served from 1995 to 1999 on an FDA advisory committee. "Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry."
The FDA's shift is felt directly in the private practice of medicine, said Dr. William L. Isley, a Kansas City, Mo., diabetes specialist. He implored the agency to reassess Rezulin three years ago after a patient he treated suffered liver failure taking the pill.
"FDA used to serve a purpose," Isley said. "A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what's been swept under the rug."
FDA officials said that they have tried conscientiously to weigh benefits versus risks in deciding whether to approve new drugs. They noted that many doctors and patients complain when a drug is withdrawn. "All drugs have risks; most of them have serious risks," said Dr. Janet Woodcock, director of the FDA's drug review center. She added that some of the withdrawn drugs were "very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one."
Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors "to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That's why drugs are prescription drugs."
In a May 12, 1999, article co-authored with FDA colleagues and published by the Journal of the American Medical Assn., Woodcock said, "The FDA and the community are willing to take greater safety risks due to the serious nature of the [illnesses] being treated."
Compared to the volume of new drugs approved, they wrote, the number of recent withdrawals "is particularly reassuring." However, agency specialists point out that both approvals and withdrawals are controlled by Woodcock and her administrators. When they consider a withdrawal, they face the unpleasant prospect of repudiating their original decision to approve.
Woodcock, 52, received her medical degree at Northwestern University and is a board-certified internist. She alluded in a recent interview to the difficulty she feels in rejecting a proposed drug that might cost a company $150 million or more to develop. She also acknowledged the commercial pressures in a March 1997 article. "Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting on the market,"
Woodcock wrote in the Food and Drug Law Journal. "On the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid." But this summer--following the eighth and ninth drug withdrawals--Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve safety concerns. "As medical practice has changed . . . it's just much more difficult for [doctors] to manage" the expanded drug supply, Woodcock said in an interview. "They rely upon us much more to make sure the drugs are safe."
Another FDA administrator, Dr. Florence Houn, voiced similar concern in remarks six months ago to industry officials: "I think the lessons learned from the drug withdrawals make us leery." Yet the imperative to move swiftly, cooperatively, remains. "We are now making decisions more quickly and more predictably while maintaining the same high standards for product safety and efficacy," FDA Commissioner Jane E. Henney said in a National Press Club speech on Dec. 12.
Motivated by AIDS
The impetus for change at the FDA emerged in 1988, when AIDS activists paralyzed operations for a day at the agency's 18-story headquarters in Rockville, Md. They demanded immediate approval of experimental drugs that offered at least a ray of hope to those otherwise facing death.
The FDA often was taking more than two years to review new drug applications. The pharmaceutical industry saw a chance to loosen the regulatory brakes and expedite an array of new products to market. The companies and their Capitol Hill lobbyists pressed for advantage: If unshackled, they said, the companies could invent and develop more remedies faster.
Dr. Rudolph M. Widmark: The medical officer retired in December 1997 after spending 11 years with the FDA. His recommendation for a black box warning on the label of painkiller Duract was rejected.
The political pressure mounted, and the FDA began to bow. By 1991, agency officials told Congress they were making significant progress in speeding the approval process. The emboldened companies pushed for more. They proposed that drugs intended for either life-threatening or "serious" disorders receive a quicker review.
"The pharmaceutical companies came back and lobbied the agency and the Hill for that word, 'serious,' " recalled Jeffrey A. Nesbit, who in 1991 was chief of staff to FDA Commissioner David A. Kessler. "Their argument was, 'Well, OK, there's AIDS and cancer. But there are drugs [being developed] for Alzheimer's. And that's a serious illness.'
They started naming other diseases. They began to push that envelope." The wielding of this single, flexible adjective--"serious"--swung wide the regulatory door knocked ajar by the AIDS crisis.
New Order Takes Hold
In 1992, Kessler issued regulations giving the FDA discretion to "accelerate approval of certain new drugs" for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application.
The newly elected Clinton administration climbed aboard with its "reinventing government" project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce "by an average of oneyear the time required to bring important new drugs to the American public."
As Clinton put it in a speech on March 16, 1995, the objective was to "get rid of yesterday's government." For the FDA's medical reviewers--the physicians, pharmacologists, chemists and biostatisticians who scrutinize the safety and effectiveness of
emerging drugs--a new order had taken hold.
The reviewers work out of public view in secure office buildings clustered along Maryland's Route 355. At the jet-black headquarters building, the decor is institutional, the corridors and third-floor cafeteria without windows. The reviewers examine truckloads of scientific
documents. They are well-educated; some are highly motivated to do their best for a nation of patients who unknowingly count on their expertise.
One of these reviewers was Michael Elashoff, a biostatistician who arrived at the FDA in 1995 after earning degrees from UC Berkeley and the Harvard School of Public Health.
"From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make," said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval. "The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza," Elashoff
wrote, adding that many patients would be exposed to risks "while deriving no benefit."
An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza. After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug.
Lost Faith in the System
Elashoff and other FDA reviewers discern a powerful message. "People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it's worth," he said. "Before I came to the FDA I guess I always assumed things were done properly. I've lost a lot of faith in taking a prescription
medicine." Elashoff left the FDA four months ago.
"Either you play games or you're going to be put off limits . . . a pariah," said Dr. John L. Gueriguian, a 19-year FDA medical officer who opposed the approval of Rezulin, the ill-fated diabetes drug. "The people in charge don't say, 'Should we approve this drug?' They say, 'Hey, how can we get this drug approved?' " Said Dr. Rudolph M. Widmark, who retired in 1997 after 11 years as a medical officer: "If you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you
are holding up the drug to your bosses. . . . You cannot imagine how much pressure is put on the reviewers."
The pressure is such that when a union representative negotiated a new employment contract for the reviewers last year, one of his top priorities was to defend what he called the "scientific integrity" of their work. "People feel swamped. People are pressured to go along with what the agency wants," said Dr. Robert S.K. Young, an FDA medical officer who in 1998 formed a union chapter to represent the reviewers. "You're paying for
these highly educated, trained people, and they're not being allowed to do their job."
Each new drug application is accompanied by voluminous medical data, enough at times to fill 1,000 or more phone books. The reviewers must master this material in less than six months or a year, while juggling other tasks. "The devil is in the details, and detail is something we no longer have the time to go into," said Gurston D. Turner, a veteran pharmacologist with the FDA's scientific investigations division who retired this year. "If you know you must have your report done by a certain date, you get something done. That's what they [top FDA officials] count, that's all they count. And that is really, to me, a worrisome thing."
The FDA did spur reviewers to move at record speed. In 1994, the FDA's goal was to finish 55% of its new drug reviews on time; the agency achieved 95%. In 1995, the goal was 70%; the FDA achieved 98%. In 1996, the goal was 80%; the FDA achieved 100%. In both 1997 and 1998, the goal was 90% and the FDA achieved 100%.
From 1993 to 1999 the agency approved 232 drugs regarded as "new molecular entities," compared with 163 during the previous seven years, a 42% increase. The time-limit goals quickly were treated as deadlines within the FDA--imposing relentless pressure on reviewers and their bosses to quickly conclude their work and approve the drugs. "The goals were to be taken seriously. I don't think anybody expected the agency to make them all," said William B. Schultz, a deputy FDA commissioner from 1995 to 1999.
Schultz, who helped craft the 1992 user-fee act as a congressional staff lawyer, added: "You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous."
Indeed, the FDA drug center's 1999 annual report referred to the review goals as "the law's deadlines." And, Dr. Woodcock, the center director, elaborated in a subsequent agency newsletter:
"In exchange [for the user fees], FDA makes a commitment to meet certain goals for review times. [The agency] has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the number of new approved drugs has doubled, and the review times have been cut in half."
The user fees have enabled the FDA to hire more medical reviewers. Last year, 236 medical officers examined new drugs compared with 162 officers on duty in 1992, the year before the user fees took effect. Even so, Woodcock acknowledged in an FDA publication this fall that the workloads and tight performance goals "create a sweatshop environment that's causing high staffing turnover."
An FDA progress report in 1998, describing the work of agency chemists, said that "too many reviews are coming 'down to the wire' against the goal date. . . . This suggests a system in stress." Said Nesbit, the former aide to Commissioner Kessler: "The clock is
always running, whereas before the clock was never running. And that changes people's behavior."
Dozens of officials interviewed by The Times made similar observations. "The pressure to meet deadlines is enormous," said Dr. Solomon Sobel, 65, director of the FDA's metabolic and endocrine drugs division throughout the 1990s. And the pressure is not merely to complete the reviews, he said. "The basic message is to approve."
Over the last seven years, "there has been a huge shift," said Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide who now is a drug industry consultant. "FDA, historically, had an approach of, 'Regulate, be tough, enforce the law [and] don't let one thing go wrong,' " Holcombe said, adding that now, "the FDA sees itself much more in
a cooperative role."
How Deaths Were Calculated
Reports of adverse drug reactions to the Food and Drug Administration are considered by public health officials to be the most reliable early warnings of a product's danger. The reports are filed to the FDA by health professionals, consumers and drug manufacturers.
The Los Angeles Times inspected all reports filed in connection with seven drugs that were
approved and withdrawn since 1993. By hand and by computer, The Times counted 1,002 deaths in which the filer identified the drug as the leading suspect. Since fall 1997, this top category has been termed "primary suspect." The Times did not count any death in which the drug was identified as the "secondary suspect" or less. The methodology and results were reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an assistant professor at the University of Maryland's department of pharmacy practice
and sciences.
The perception of coziness with drug makers is perpetuated by potential conflicts of interest within the FDA's 18 advisory committees, the influential panels that recommend which drugs deserve approval or should remain on the market. The FDA allows some appointees to double as consultants or researchers for the same companies whose products they are evaluating on the public's behalf. Such was the case during committee
appraisals of several of the recently withdrawn drugs, including Lotronex and Posicor, The Times found.
Few doubt the $100-billion pharmaceutical industry's clout. Over the last decade, the drug companies have steered $44 million in contributions to the major political parties and to candidates for the White House and both houses of Congress.
The FDA reviewers said they and their bosses fear that unless the new drugs are approved, companies will erupt and Congress will retaliate by refusing to renew the user fees. This would cripple FDA operations--and jeopardize jobs.
The companies' money now covers about 50% of the FDA's costs for reviewing proposed drugs--and agency officials say that persuading Congress to renew the user fees into 2007 is now a top priority.
Yet even if the user fees remain, the FDA is prohibited from spending the revenue for anything other than reviewing new drugs. So while the budget for pre-approval reviews has soared, the agency has gotten no similar increase of resources to evaluate the safety of the drugs after they are prescribed.
"It's shocking," said Dr. Brian L. Strom, chairman of epidemiology at the University of Pennsylvania. "How can you say, 'Release drugs to the market sooner,' and not know if they're killing people? . . . It really is a dramatic statement of public priorities."
More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported each year. And those "adverse-event" reports by doctors and others are only filed voluntarily. Experts, including Strom, believe the reports represent as few as 1% to 10% of all such events. "There's no incentive at all for a physician to report [an adverse drug reaction]," said Strom, who has documented the phenomenon. "The underreporting is vast."
Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including preexisting disease or use of another medicine.
To be sure, a chain of events affects the safe use of a prescription drug: The companies' conduct of clinical studies; the FDA's regulatory actions; the doctor's decision to prescribe; the pharmacist's filling of a handwritten prescription; the patient's ability to take the drug as
directed. A lapse at any link could prove fatal. And once a pill is approved by the FDA, the manufacturer often spends heavily on promotion to seize the largest possible market share. This can exacerbate the risk to public health, according to experts.
"Aggressive promotion increases exposure--and doesn't give you the time to find the problem before patients get hurt," said Dr. Raymond L. Woosley, pharmacology department chairman at Georgetown University and a former FDA advisory committee member.
When serious side effects emerge, the FDA officials have championed using package labeling as a way to, in their words, "manage" risks. Yet the agency typically has no way to know if the labeling precautions--dense, lengthy and in tiny print--are read or followed by doctors and their patients.
The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. But the research frequently is not performed--prompting the inspector general of the Department of Health and Human Services to say in 1996 that "FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence."
Since that report was issued, the FDA has not withdrawn any drug due to a company's failure to complete a post-approval safety study. Officials conceded this week that they still do not know how often the studies are performed.
One consequence is that greater risk is shifted to doctors and patients. For example, Woodcock and her senior aides allowed Rezulin to remain on the U.S. market nearly 2� years after it was withdrawn in Britain in December 1997. The FDA recommended frequent laboratory testing of patients using the drug but had no scientific assurance that the tests would prevent Rezulin-induced liver failure.
"They kept increasing the number of liver-function tests you should have," noted Dr. Alastair J.J. Wood, a former FDA advisory committee member who is a professor of medicine at Vanderbilt University. "That was clearly designed to protect the FDA, to protect the manufacturer, and to dump the responsibility on the patient and the physician. If the patient developed liver disease and he hadn't had his [tests] done, somebody was to blame and it wasn't the manufacturer and it wasn't the FDA."
Industry Assurances
Leading industry officials say Americans have nothing to fear from the wave of drug approvals. "Do unsafe drugs enter and remain in the marketplace? Absolutely not,"
said Dr. Bert A. Spilker, senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, in remarks last year to industry and FDA scientists.
But during interviews over the last two years, current and former FDA specialists cited repeated instances when drugs were approved with less than compelling evidence of safety or effectiveness. They also said that important information has been excluded from the labels on some medications.
Elashoff, for instance, was surprised at the labeling for a drug called Prograf, approved in 1997 to prevent rejection of transplanted kidneys. The drug first had been approved in 1994 for use among liver-transplant patients.
The new label notes that Prograf was proved effective in a study of 412 U.S. kidney transplant patients. But no mention is made of the company's 448-patient European study, in which 7% of the patients who took Prograf died--double the 3.5% death rate among those who received a different anti-rejection drug, documents show.
An auditor from the FDA's scientific investigations unit, Antoine El-Hage, examined the European study results and concluded the "data are reliable." Elashoff agreed in his review. Yet the only way for doctors or patients to find that data is to search the medical literature or seek the FDA's review documents. Excluding the European study from the Prograf label, Elashoff said, "was just a total whitewash. . . . I think any rational person would reconsider taking this drug if they knew what happened in Europe."
A spokesman for the manufacturer of Prograf said the company had no objection to including the European study results in the labeling. William E. Fitzsimmons, a vice president of drug development for Fujisawa Healthcare Inc., said the decision to exclude the results was entirely the FDA's. "We submitted that data," he said. "It came down to what the FDA was comfortable putting in the label. . . . We certainly have no interest in trying to hide that information. We presented it at major meetings on
transplantation. . . . We're comfortable with that information being out in the public domain."
But if the FDA had included the European results in the label, it would have impugned the agency's basis for approving the new, expanded use for Prograf, according to Elashoff and others. Asked why the agency excluded the information, Woodcock said the European results were "unreliable . . . and could be potentially misleading to doctors and patients in the U.S. if these were included in the label."
How a New Policy Led to Seven Deadly Drugs
Once a wary watchdog, the Food and Drug Administration set out to become a "partner" of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal.
By DAVID WILLMAN
Times Staff Writer
WASHINGTON--For most of its history, the United States Food and Drug Administration approved new prescription medicines at a grudging pace, paying daily homage to the physician's creed, "First, do no harm." Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as "partners, not adversaries."
Dr. Janet Woodcock, director of the FDA's drug-review center, says the agency depends on doctors "to take into account the risks, to read the label. ... That's why drugs are prescription drugs."
The FDA achieved its new goals, but now the human cost is becoming clear. Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.
According to "adverse-event" reports filed with the FDA, the seven drugs were cited as suspects in 1,002 deaths. Because the deaths are reported by doctors, hospitals and others on a voluntary basis, the true number of fatalities could be far higher, according to epidemiologists. An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role. But the reports are regarded by public health officials as the most reliable early warnings of danger.
The FDA's performance was tracked through an examination of thousands of pages of government documents, other data obtained under the Freedom of Information Act and interviews with more than 60 present and former agency officials.
The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for its speed than its caution. In 1988, only 4% of new drugs introduced into the world market were approved first by the FDA. In 1998, the FDA's first-in-the-world approvals spiked to 66%.
The drug companies' batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80% of the industry's applications for new products, compared with about 60% at the beginning of the decade. And the companies have prospered: The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.
Once the world's unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe. Michael Elashoff: The biostatistician was upbraided by senior FDA officials after he recommended against the approval of Relenza, a new flu drug. An agency advisory committee agreed with him, but the drug was approved by the FDA as safe and effective.
"This track record is totally unacceptable," said Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University. "The patients are the ones paying the price. They're the ones developing all the side effects, fatal and non-fatal. Someone has to speak up for them."
The FDA's faster and more lenient approach helped supply pharmacy shelves with scores of new remedies. But it has also yielded these fatal missteps, according to the documents and interviews:
* Only 10 months ago, FDA administrators dismissed one of its medical officer's emphatic warnings and approved Lotronex, a drug for treating irritable bowel syndrome. Lotronex has been linked to five deaths, the removal of a patient's colon and other bowel surgeries. It was pulled off the market on Nov. 28.
* The diet pill Redux, approved in April 1996 despite an advisory committee's vote against it, was withdrawn in September 1997 after heart-valve damage was detected in patients put on the drug. The FDA later received reports identifying Redux as a suspect in 123 deaths.
* The antibiotic Raxar was approved in November 1997 in the face of evidence that it may have caused several fatal heart-rhythm disruptions in clinical studies. FDA officials chose to exclude any mention of the deaths from the drug's label. The maker of the pill withdrew it in October 1999. Raxar was cited as a suspect in the deaths of 13 patients.
* The blood pressure medication Posicor was approved in June 1997 despite findings by FDA specialists that it might fatally disrupt heart rhythm and interact with certain other drugs, posing potentially severe risk. Posicor was withdrawn one year later; reports cited it as a suspect in 100 deaths.
* The painkiller Duract was approved in July 1997 after FDA medical officers warned repeatedly of the drug's liver toxicity. Senior officials sided with the manufacturer in softening the label's warning of the liver threat. The drug was withdrawn 11 months later. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure.
* The diabetes drug Rezulin was approved in January 1997 over a medical officer's detailed opposition and was withdrawn this March after the agency had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect in 391 deaths.
* The nighttime heartburn drug Propulsid was approved in 1993 despite evidence that it caused heart-rhythm disorders. The officials who approved the drug failed to consult the agency's own cardiac specialists about the signs of danger. The drug was taken out of pharmacies in July after scores of confirmed heart-rhythm deaths.
Overall, Propulsid has been cited as a suspect in 302 deaths. The FDA's handling of Propulsid put children at risk. The agency never warned doctors not to administer the drug to infants or other children even though eight youngsters given Propulsid in clinical studies had died. Pediatricians prescribed it widely for infants afflicted with gastric reflux, a common digestive disorder.
Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be "not approvable" for children. "We never knew that," said Jeffrey A. Englebrick, a heavy-equipment welder in Shawnee, Kan., whose 3-month-old son, Scott, died on Oct. 28, 1997, after taking Propulsid. "To me, that means they took my kid as a guinea pig to see if it would work." By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.
Questions also surround the recent approvals of other compounds that remain on the market, including a new flu drug called Relenza. In February of 1999, an FDA advisory committee concluded that Relenza had not been proved safe and effective. The agency nevertheless approved it. Following the deaths of seven patients, the FDA in January issued a "public health advisory" to doctors.
A 'Lost Compass'
A total of 10 drugs have been pulled from the market in just the past three years for safety reasons, including three pills that were approved before the shift that took hold in 1993. Never before has the FDA overseen the withdrawals of so many drugs in such a short time. More than 22 million Americans--about 10% of the nation's adult population--took those drugs.
With many of the drugs, the FDA used tiny-print warnings or recommendations in package labeling as a way to justify approvals or stave off withdrawals. In other instances, the agency has withheld safety information from labels that physicians say would call into question the use of the product.
Present and former FDA specialists said the regulatory decisions of senior officials have clashed with the agency's central obligation, under law, to "protect the public health by ensuring . . . that drugs are safe and effective."
"They've lost their compass and they forget who it is that they are ultimately serving," said Dr. Lemuel A. Moye, a University of Texas School of Public Health physician who served from 1995 to 1999 on an FDA advisory committee. "Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry."
The FDA's shift is felt directly in the private practice of medicine, said Dr. William L. Isley, a Kansas City, Mo., diabetes specialist. He implored the agency to reassess Rezulin three years ago after a patient he treated suffered liver failure taking the pill.
"FDA used to serve a purpose," Isley said. "A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what's been swept under the rug."
FDA officials said that they have tried conscientiously to weigh benefits versus risks in deciding whether to approve new drugs. They noted that many doctors and patients complain when a drug is withdrawn. "All drugs have risks; most of them have serious risks," said Dr. Janet Woodcock, director of the FDA's drug review center. She added that some of the withdrawn drugs were "very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one."
Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors "to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That's why drugs are prescription drugs."
In a May 12, 1999, article co-authored with FDA colleagues and published by the Journal of the American Medical Assn., Woodcock said, "The FDA and the community are willing to take greater safety risks due to the serious nature of the [illnesses] being treated."
Compared to the volume of new drugs approved, they wrote, the number of recent withdrawals "is particularly reassuring." However, agency specialists point out that both approvals and withdrawals are controlled by Woodcock and her administrators. When they consider a withdrawal, they face the unpleasant prospect of repudiating their original decision to approve.
Woodcock, 52, received her medical degree at Northwestern University and is a board-certified internist. She alluded in a recent interview to the difficulty she feels in rejecting a proposed drug that might cost a company $150 million or more to develop. She also acknowledged the commercial pressures in a March 1997 article. "Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting on the market,"
Woodcock wrote in the Food and Drug Law Journal. "On the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid." But this summer--following the eighth and ninth drug withdrawals--Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve safety concerns. "As medical practice has changed . . . it's just much more difficult for [doctors] to manage" the expanded drug supply, Woodcock said in an interview. "They rely upon us much more to make sure the drugs are safe."
Another FDA administrator, Dr. Florence Houn, voiced similar concern in remarks six months ago to industry officials: "I think the lessons learned from the drug withdrawals make us leery." Yet the imperative to move swiftly, cooperatively, remains. "We are now making decisions more quickly and more predictably while maintaining the same high standards for product safety and efficacy," FDA Commissioner Jane E. Henney said in a National Press Club speech on Dec. 12.
Motivated by AIDS
The impetus for change at the FDA emerged in 1988, when AIDS activists paralyzed operations for a day at the agency's 18-story headquarters in Rockville, Md. They demanded immediate approval of experimental drugs that offered at least a ray of hope to those otherwise facing death.
The FDA often was taking more than two years to review new drug applications. The pharmaceutical industry saw a chance to loosen the regulatory brakes and expedite an array of new products to market. The companies and their Capitol Hill lobbyists pressed for advantage: If unshackled, they said, the companies could invent and develop more remedies faster.
Dr. Rudolph M. Widmark: The medical officer retired in December 1997 after spending 11 years with the FDA. His recommendation for a black box warning on the label of painkiller Duract was rejected.
The political pressure mounted, and the FDA began to bow. By 1991, agency officials told Congress they were making significant progress in speeding the approval process. The emboldened companies pushed for more. They proposed that drugs intended for either life-threatening or "serious" disorders receive a quicker review.
"The pharmaceutical companies came back and lobbied the agency and the Hill for that word, 'serious,' " recalled Jeffrey A. Nesbit, who in 1991 was chief of staff to FDA Commissioner David A. Kessler. "Their argument was, 'Well, OK, there's AIDS and cancer. But there are drugs [being developed] for Alzheimer's. And that's a serious illness.'
They started naming other diseases. They began to push that envelope." The wielding of this single, flexible adjective--"serious"--swung wide the regulatory door knocked ajar by the AIDS crisis.
New Order Takes Hold
In 1992, Kessler issued regulations giving the FDA discretion to "accelerate approval of certain new drugs" for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application.
The newly elected Clinton administration climbed aboard with its "reinventing government" project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce "by an average of oneyear the time required to bring important new drugs to the American public."
As Clinton put it in a speech on March 16, 1995, the objective was to "get rid of yesterday's government." For the FDA's medical reviewers--the physicians, pharmacologists, chemists and biostatisticians who scrutinize the safety and effectiveness of
emerging drugs--a new order had taken hold.
The reviewers work out of public view in secure office buildings clustered along Maryland's Route 355. At the jet-black headquarters building, the decor is institutional, the corridors and third-floor cafeteria without windows. The reviewers examine truckloads of scientific
documents. They are well-educated; some are highly motivated to do their best for a nation of patients who unknowingly count on their expertise.
One of these reviewers was Michael Elashoff, a biostatistician who arrived at the FDA in 1995 after earning degrees from UC Berkeley and the Harvard School of Public Health.
"From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make," said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval. "The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza," Elashoff
wrote, adding that many patients would be exposed to risks "while deriving no benefit."
An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza. After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug.
Lost Faith in the System
Elashoff and other FDA reviewers discern a powerful message. "People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it's worth," he said. "Before I came to the FDA I guess I always assumed things were done properly. I've lost a lot of faith in taking a prescription
medicine." Elashoff left the FDA four months ago.
"Either you play games or you're going to be put off limits . . . a pariah," said Dr. John L. Gueriguian, a 19-year FDA medical officer who opposed the approval of Rezulin, the ill-fated diabetes drug. "The people in charge don't say, 'Should we approve this drug?' They say, 'Hey, how can we get this drug approved?' " Said Dr. Rudolph M. Widmark, who retired in 1997 after 11 years as a medical officer: "If you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you
are holding up the drug to your bosses. . . . You cannot imagine how much pressure is put on the reviewers."
The pressure is such that when a union representative negotiated a new employment contract for the reviewers last year, one of his top priorities was to defend what he called the "scientific integrity" of their work. "People feel swamped. People are pressured to go along with what the agency wants," said Dr. Robert S.K. Young, an FDA medical officer who in 1998 formed a union chapter to represent the reviewers. "You're paying for
these highly educated, trained people, and they're not being allowed to do their job."
Each new drug application is accompanied by voluminous medical data, enough at times to fill 1,000 or more phone books. The reviewers must master this material in less than six months or a year, while juggling other tasks. "The devil is in the details, and detail is something we no longer have the time to go into," said Gurston D. Turner, a veteran pharmacologist with the FDA's scientific investigations division who retired this year. "If you know you must have your report done by a certain date, you get something done. That's what they [top FDA officials] count, that's all they count. And that is really, to me, a worrisome thing."
The FDA did spur reviewers to move at record speed. In 1994, the FDA's goal was to finish 55% of its new drug reviews on time; the agency achieved 95%. In 1995, the goal was 70%; the FDA achieved 98%. In 1996, the goal was 80%; the FDA achieved 100%. In both 1997 and 1998, the goal was 90% and the FDA achieved 100%.
From 1993 to 1999 the agency approved 232 drugs regarded as "new molecular entities," compared with 163 during the previous seven years, a 42% increase. The time-limit goals quickly were treated as deadlines within the FDA--imposing relentless pressure on reviewers and their bosses to quickly conclude their work and approve the drugs. "The goals were to be taken seriously. I don't think anybody expected the agency to make them all," said William B. Schultz, a deputy FDA commissioner from 1995 to 1999.
Schultz, who helped craft the 1992 user-fee act as a congressional staff lawyer, added: "You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous."
Indeed, the FDA drug center's 1999 annual report referred to the review goals as "the law's deadlines." And, Dr. Woodcock, the center director, elaborated in a subsequent agency newsletter:
"In exchange [for the user fees], FDA makes a commitment to meet certain goals for review times. [The agency] has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the number of new approved drugs has doubled, and the review times have been cut in half."
The user fees have enabled the FDA to hire more medical reviewers. Last year, 236 medical officers examined new drugs compared with 162 officers on duty in 1992, the year before the user fees took effect. Even so, Woodcock acknowledged in an FDA publication this fall that the workloads and tight performance goals "create a sweatshop environment that's causing high staffing turnover."
An FDA progress report in 1998, describing the work of agency chemists, said that "too many reviews are coming 'down to the wire' against the goal date. . . . This suggests a system in stress." Said Nesbit, the former aide to Commissioner Kessler: "The clock is
always running, whereas before the clock was never running. And that changes people's behavior."
Dozens of officials interviewed by The Times made similar observations. "The pressure to meet deadlines is enormous," said Dr. Solomon Sobel, 65, director of the FDA's metabolic and endocrine drugs division throughout the 1990s. And the pressure is not merely to complete the reviews, he said. "The basic message is to approve."
Over the last seven years, "there has been a huge shift," said Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide who now is a drug industry consultant. "FDA, historically, had an approach of, 'Regulate, be tough, enforce the law [and] don't let one thing go wrong,' " Holcombe said, adding that now, "the FDA sees itself much more in
a cooperative role."
How Deaths Were Calculated
Reports of adverse drug reactions to the Food and Drug Administration are considered by public health officials to be the most reliable early warnings of a product's danger. The reports are filed to the FDA by health professionals, consumers and drug manufacturers.
The Los Angeles Times inspected all reports filed in connection with seven drugs that were
approved and withdrawn since 1993. By hand and by computer, The Times counted 1,002 deaths in which the filer identified the drug as the leading suspect. Since fall 1997, this top category has been termed "primary suspect." The Times did not count any death in which the drug was identified as the "secondary suspect" or less. The methodology and results were reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an assistant professor at the University of Maryland's department of pharmacy practice
and sciences.
The perception of coziness with drug makers is perpetuated by potential conflicts of interest within the FDA's 18 advisory committees, the influential panels that recommend which drugs deserve approval or should remain on the market. The FDA allows some appointees to double as consultants or researchers for the same companies whose products they are evaluating on the public's behalf. Such was the case during committee
appraisals of several of the recently withdrawn drugs, including Lotronex and Posicor, The Times found.
Few doubt the $100-billion pharmaceutical industry's clout. Over the last decade, the drug companies have steered $44 million in contributions to the major political parties and to candidates for the White House and both houses of Congress.
The FDA reviewers said they and their bosses fear that unless the new drugs are approved, companies will erupt and Congress will retaliate by refusing to renew the user fees. This would cripple FDA operations--and jeopardize jobs.
The companies' money now covers about 50% of the FDA's costs for reviewing proposed drugs--and agency officials say that persuading Congress to renew the user fees into 2007 is now a top priority.
Yet even if the user fees remain, the FDA is prohibited from spending the revenue for anything other than reviewing new drugs. So while the budget for pre-approval reviews has soared, the agency has gotten no similar increase of resources to evaluate the safety of the drugs after they are prescribed.
"It's shocking," said Dr. Brian L. Strom, chairman of epidemiology at the University of Pennsylvania. "How can you say, 'Release drugs to the market sooner,' and not know if they're killing people? . . . It really is a dramatic statement of public priorities."
More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported each year. And those "adverse-event" reports by doctors and others are only filed voluntarily. Experts, including Strom, believe the reports represent as few as 1% to 10% of all such events. "There's no incentive at all for a physician to report [an adverse drug reaction]," said Strom, who has documented the phenomenon. "The underreporting is vast."
Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including preexisting disease or use of another medicine.
To be sure, a chain of events affects the safe use of a prescription drug: The companies' conduct of clinical studies; the FDA's regulatory actions; the doctor's decision to prescribe; the pharmacist's filling of a handwritten prescription; the patient's ability to take the drug as
directed. A lapse at any link could prove fatal. And once a pill is approved by the FDA, the manufacturer often spends heavily on promotion to seize the largest possible market share. This can exacerbate the risk to public health, according to experts.
"Aggressive promotion increases exposure--and doesn't give you the time to find the problem before patients get hurt," said Dr. Raymond L. Woosley, pharmacology department chairman at Georgetown University and a former FDA advisory committee member.
When serious side effects emerge, the FDA officials have championed using package labeling as a way to, in their words, "manage" risks. Yet the agency typically has no way to know if the labeling precautions--dense, lengthy and in tiny print--are read or followed by doctors and their patients.
The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. But the research frequently is not performed--prompting the inspector general of the Department of Health and Human Services to say in 1996 that "FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence."
Since that report was issued, the FDA has not withdrawn any drug due to a company's failure to complete a post-approval safety study. Officials conceded this week that they still do not know how often the studies are performed.
One consequence is that greater risk is shifted to doctors and patients. For example, Woodcock and her senior aides allowed Rezulin to remain on the U.S. market nearly 2� years after it was withdrawn in Britain in December 1997. The FDA recommended frequent laboratory testing of patients using the drug but had no scientific assurance that the tests would prevent Rezulin-induced liver failure.
"They kept increasing the number of liver-function tests you should have," noted Dr. Alastair J.J. Wood, a former FDA advisory committee member who is a professor of medicine at Vanderbilt University. "That was clearly designed to protect the FDA, to protect the manufacturer, and to dump the responsibility on the patient and the physician. If the patient developed liver disease and he hadn't had his [tests] done, somebody was to blame and it wasn't the manufacturer and it wasn't the FDA."
Industry Assurances
Leading industry officials say Americans have nothing to fear from the wave of drug approvals. "Do unsafe drugs enter and remain in the marketplace? Absolutely not,"
said Dr. Bert A. Spilker, senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, in remarks last year to industry and FDA scientists.
But during interviews over the last two years, current and former FDA specialists cited repeated instances when drugs were approved with less than compelling evidence of safety or effectiveness. They also said that important information has been excluded from the labels on some medications.
Elashoff, for instance, was surprised at the labeling for a drug called Prograf, approved in 1997 to prevent rejection of transplanted kidneys. The drug first had been approved in 1994 for use among liver-transplant patients.
The new label notes that Prograf was proved effective in a study of 412 U.S. kidney transplant patients. But no mention is made of the company's 448-patient European study, in which 7% of the patients who took Prograf died--double the 3.5% death rate among those who received a different anti-rejection drug, documents show.
An auditor from the FDA's scientific investigations unit, Antoine El-Hage, examined the European study results and concluded the "data are reliable." Elashoff agreed in his review. Yet the only way for doctors or patients to find that data is to search the medical literature or seek the FDA's review documents. Excluding the European study from the Prograf label, Elashoff said, "was just a total whitewash. . . . I think any rational person would reconsider taking this drug if they knew what happened in Europe."
A spokesman for the manufacturer of Prograf said the company had no objection to including the European study results in the labeling. William E. Fitzsimmons, a vice president of drug development for Fujisawa Healthcare Inc., said the decision to exclude the results was entirely the FDA's. "We submitted that data," he said. "It came down to what the FDA was comfortable putting in the label. . . . We certainly have no interest in trying to hide that information. We presented it at major meetings on
transplantation. . . . We're comfortable with that information being out in the public domain."
But if the FDA had included the European results in the label, it would have impugned the agency's basis for approving the new, expanded use for Prograf, according to Elashoff and others. Asked why the agency excluded the information, Woodcock said the European results were "unreliable . . . and could be potentially misleading to doctors and patients in the U.S. if these were included in the label."
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