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MY STORY
Abridged
Version Of A May 31, 2002
Presented
By Terence H. Young …died March 19, 2000 after taking the prescription drug Prepulsid
My name
is Terence Young and on my left is my daughter Madeline.
On March 19, 2000 my fifteen year old daughter Vanessa died suddenly after taking as directed a widely prescribed Johnson and Johnson drug- Prepulsid. We had absolutely no warning that Prepulsid held any danger. We thought of it as a sort of super Rolaids. Yet Prepulsid at that time was associated with 80 deaths and hundreds of injuries, including many children. No one saw fit to tell us. Prepulsid was ordered off the market in the U.S. just three days later. Vanessa’s story illustrates so well what is wrong with the drug safety in Canada, and what needs to be done to improve it.
The number of deaths linked to Prepulsid has now grown to 302 and I believe is actually far, far higher. It has also been ordered off the market in Canada, the EEC, Bangladesh and elsewhere. Vanessa’s death is outrage. Prepulsid isn’t a drug for cancer, or any other fatal disease. It’s a drug for heartburn or bloating. There was never any justification to give this potentially life threatening drug to treat non-life threatening symptoms. It was not even approved for children. With Prepulsid the body count began in the early nineties and continued to rise for ten years. Instead of taking Prepulsid off the market, or at least issuing clear patient warnings, its manufacturer, Johnson and Johnson changed the fine print on the label five times. By 1998, Johnson and Johnson, the people who make our baby powder, was still selling a billion dollars worth of Prepulsid a year in North America alone, for children, seniors, and incredibly, hundreds of infants. Two
hundred and twenty-nine people died when Swiss Air Flight 111 crashed
off the coast of Newfoundland. More than 100,000 people die every year due to prescription drugs in North America- roughly ten thousand Canadians. Yet I feel the government of Canada does little to find out how to help prevent further deadly incidents. We are here today to speak for Vanessa and the thousands of innocent drug victims now gone who cannot speak for themselves… those who were robbed of their lives and those who suffered permanent damage due to what amounts to a conspiracy of silence. We are also here to caution you and others that think it couldn’t happen in their family. The truth is, it could. Anyone who takes prescription drugs is at risk. The Drug Companies: the source of the problem "We view Health Canada as our best customer" - Wendy Arnott, Janssen-Ortho VP of Regulatory Affairs and Linguistics (my italics) Canadians will spend over $15 billion this year on prescription drugs, more than they do on doctors, and this number is growing- astronomically. In 1991, it was small percentage of the total cost of health care. This year it will top 15%, comprising the single greatest threat to the sustainability of medicare. A large portion of these drugs are taken inappropriately, wasting scarce government funds and endangering patients. The drug companies claim it’s the cost of R& D that’s driving costs up. That self serving claim is simply not credible. Please consider the following. 1. Drug companies are the most profitable corporations in the world with profit margins which are multiples of the average of Fortune 500 companies.
With Prepulsid, every month’s delay meant another $ 7 M in Canadian sales Drug companies argue -straight faced - that they can’t provide proper safety warnings such as ads in newspapers- because patients might stop taking their medication. This is preposterous when they know that the truth is the opposite: warnings are generally ignored or at best inspire a call to one’s doctor. They even have Health Canada officials repeating this dangerous myth. When asked on the stand at the Inquest into Vanessa’s death why Health Canada hadn’t issued or ordered a full media warning for Prepulsid long before it was withdrawn Dr. Brian Gillespie said it might have caused panic and people might have stopped taking the pills. No one ever died from not taking Prepulsid. Proof this position is lame excuse is with recent warnings in the media regarding PPF and Ephedrine on the same day. There was certainly no panic, and no one died. No drug company has ever been sued for providing a proper safety warning. But perhaps this explains something else. In November, 1998 it was discovered that President Clinton was taking Propulsid with a contraindicated drug- omeprazole. He could have died. In fact President Bush, his predecessor passed out at state function in Japan due to an adverse reaction to another drug. Clinton’s administration was about to order Johnson and Johnson for the first time in history to put a boxed warning right on the bottle of pills the patients gets in hand and a package insert which states the warning up front in plain language. Because most of the regulatory authorities in most other countries are, like Canada’s, under funded, they normally copy FDA orders. To avoid having to place a real warning on the bottle of pills in all other 118 countries they sold Prepulsid, and so damage sales world wide for one of their most profitable drugs, Johnson and Johnson "voluntarily" offered to do so as a "pilot project". This was no more a voluntary pilot project than a roadside drunk driver walking the line to avoid arrest, but was nevertheless a major event in drug safety. In 1998, Propulsid (U.S. spelling) thanks to the FDA, was only sold in the U.S, with a proper warning written up-front in plain language which said "May be fatal…’ in the first paragraph in bold print. What did Johnson and Johnson do in Canada? Nothing. What did Health Canada do? Nothing. What warning did Canadian patients receive? Nothing. Vanessa and others may be alive if they either had the decency or responsibility to provide Canadians the same warnings they did Americans. Most drug company senior executives and all sales staff from top to bottom are paid based on how many pills the company sells. At the Inquest into Vanessa’s death none of four doctors testified ever receiving a safety warning about Prepulsid from company sales reps. And no one is paid or recognized for providing or issuing excellent safety warnings. I would question how long a sales representative would last on the job who did so.
4. The drug companies know that many of our doctors will write out a prescription for a drug if asked about it in their offices. 5. Safety Warnings issued by letter or fax to doctors are likewise inadequate. That’s for two reasons; One, they are written in many cases when the company should instead have just pulled the drug off the market. Second, despite the fact that most doctors don’t read the warnings, for those that do, the company wants to minimize loss of sales. Here’s a quote from minutes of the Health Canada Meeting of The Expert Advisory Committee on Pharmacovigilence in November 1998 almost a year and half before Vanessa died. Even edited the message is clear: "It (Prepulsid) appears to enjoy much off-label use. Cisipride (Prepulsid) associated with toxic side effects but, because there is no means for predicting which individual will benefit, a large number of people will be administered the drug, exposing them unnecessarily to its adverse reactions. It was pointed out that regulatory action had been taken: a Dear Health Care professional letter was issued by the manufacturer with numerous additional warnings. It was suggested that, in this letter the warnings should have been stated up front in a concise manner, with details listed thereafter. It has now become a very onerous task for the physician to determine whether the benefits outweigh the risks." There was further reference to the Dear doctor letters. "It was felt they were not very effective, especially when the manufacturer is the source. Changes in design, format and content were discussed. Absolute vs. relative risk and the impact of direct to consumer advertising was discussed. They also suggested "…different wording for the health care professional and the public," and with regards to the mailing envelopes "specially marked brightly coloured to indicate the source and make it stand out. The group felt at present the letters were largely ignored and had little impact." "The name of the drug should be on the outside of the Dear Doctor letter." and " …an alternative mechanism for disseminating important information about the safe use of drugs should be sought."
This meeting was attended by fourteen doctors and seven Health Canada senior staff. We wrote to the Committee Coordinator, Bob Li eighteen months later, to ask what substantive actions Health Canada taken to address this dangerous situation. The answer? Nothing. They put a message in a bottle, writing an article for the Adverse Reaction Newsletter, another publication most doctors probably don’t read. 6. Of course, faxed safety warnings to Doctors can’t hurt sales if they aren’t sent out. In January 2000 Janssen-Ortho and Health Canada had one last chance to protect Canadians from the dangers of Prepulsid. Health Canada failed miserably. In January the FDA ordered a faxed warning sent out in 48 hours to every doctor in the U.S. ordering that the drug should only be administered after an ECG test. Rather than do what they had the authority and responsibility to do, which is order Prepulsid off the shelves within 48 hours in Canada Health Canada negotiated with Jannsen-Ortho. This delayed the inevitable order to withdraw Prepulsid for seven months, until August 7, 2000. 7 Johnson and Johnson is still selling Prepulsid in numerous countries; in some, directly off the shelf for one reason - they haven’t been ordered not to.
Recommendation # 1: Any clinical trial for a drug should be registered upon initiation with a government body, and its results made public upon completion. If the trial is not completed its partial results should also be made public.
The Doctors - our "Learned Intermediaries"Learned Intermediaries is the legal term for the role our doctors are supposed to play between patients and doctors. It is also the basis for drug companies to deny culpability in court for putting risky drugs on the market and for not taking them off the market when the dangers become apparent. They claim it is not up to them to warn patients. It’s up to the doctors. Well this term may have been appropriate a hundred years ago or perhaps even the first half of this century but the sad reality today is that doctors usually are not very "learned" with drugs at all, and no one knows this better than the drug companies. This is not to disparage experts at all. But the average medical student graduates after four years of intensive learning has taken only one, and sometimes no courses specifically on pharmacology. There are over twenty thousand prescription drugs on the market. Hundreds are added every year. Every one of those drugs has side effects, many potentially dangerous. The number of potential interactions between drugs is in the millions. Yet medical school graduates are licenced to prescribe any drug for any illness to any patient at any time if it has been approved for some indication. An example is Prepulsid, which was widely prescribed for infants and children, despite the fact it was never proven safe or approved for pediatric use and had in fact killed numerous children. If the doctors were "learned intermediaries" would they have prescribed Prepulsid as they did? 1. Doctors get most of their information on prescription drugs from commissioned drug company sales representatives - referred to as ‘detail men’. Needless to say the detail men provide minimum detail on safety warnings. Its bad for business. The doctors themselves, as a group some of the most decent people in our society are oblivious to their own complicity. Four doctors were asked at the inquest into Vanessa’s death if they ever received any safety messages regarding Prepulsid from Janssen-Ortho sales reps. They all replied, no. Of course not. It's bad for business. Getting your information about cars from a commissioned sales rep. might be alright when buying a vehicle which has already met stringent government standards for safety in the manufacturing process. But this is life and death, with drugs that are often still in "Phase IV"testing, which is, by the way means selling it on the open market. If you try any new drug, you are in fact participating in a giant drug trial for a drug which might not yet have been tested on more than 3000 patients. The problem with that is, a drug interaction that might kill say one out of 8000 patients has yet to be revealed. You might be the one. Or your family member. Doctors are targeted by detail reps, if they write a lot of prescriptions, and called "high scrip docs". They are given free gifts- everything from coffee cups, free samples and pens, as well as free dinners at expensive restaurants, tickets to sporting events, ski weekends and even trips to exotic locations- all in the name of CME (Continuing Medical Education) Most people I’ve spoken to are shocked to discover their doctors not only get their information from commissioned sales representatives, but the doctors as a group see nothing wrong with this and don’t think it affects their judgement. Does anyone think that the president of a drug company would authorize taking 100 doctors away on a ski weekend, all expenses paid, if he didn’t expect it would increase sales? Is there anyone who thinks this would be done out of kindness? Of course the evidence shows doctors do change their prescribing habits when they have a debt of gratitude to drug companies, and do work to get the drugs on the formularies of the hospitals as well. 2. Most doctors don’t read the safety warnings for prescription drugs. When was the last time you saw your doctor or pharmacist take the big blue book in his or her office (the CPS) to look up information on a drug? Most don’t rely on it. There are number of reasons. Part of the problem is that the warnings therein are written by the drug companies and so are not considered to be totally credible, with good reason. CPS stands for Compendium of Pharmaceutical Specialties. On first glance it is impressive. Surely a crack team of medical experts has edited this resource manual to help ensure it helps protect our families against inappropriate prescribing! Wrong. The CPS is basically a bunch of drug company monographs (the document Health Canada approves) glued together in alphabetical order. Believe it or not, interspersed with this critical safety information are numerous full page, colour drug ads. If the drug company or publisher sends them along. it may contain monographs for new drugs as well. Then again it may not. A family member was recently prescribed a drug which was relatively new and neither the pharmacy, nor the doctor had a copy of the monograph. Both made special calls on my request to get the safety information. But perhaps one reason some doctors don’t use the CPS as often as they might is they privately recognize it publishes incomplete numbers of adverse reactions to drugs - 1% to 10 % or less of the real number - because they know they themselves don’t report adverse reactions as they should. Adverse reaction reporting is voluntary. For patients as with drug company warnings, it''s not what you hear that can kill you, its what you don’t. What doctor faced with a waiting room full of patients wants to pause and fill out a form to send to Health Canada that states I think I harmed or almost killed one of my patients? And yet with modern computers the internet and fax machines any doctor could in ten minutes fill out a form "Suspected Adverse Reaction" and send it out. That would provide an alarm or early warning system for new drugs, or drugs being prescribed outside their original approval which would no doubt save lives. If Health Canada received three hundred reports for arrhythmia’s for a new drug in the first month, they could if they were so inclined order it off the market within 48 hours, a power they now hold and rarely use. Adverse reaction reporting is compulsory in parts of Europe. Recommendation # 2: Reporting suspected adverse reactions to prescription drugs should be made compulsory under law by doctors and pharmacists and a new arms length Drug Safety Agency have as part of its mandate the power and responsibility to receive and act on these reports, including the power to issue media warnings and order a drug taken off the market within 48 hours. The More you say the less you say...
Another problem for doctors is the sheer volume of documentation that all appears the same. Doctors would assume when a drug is found to be dangerous it would be with- drawn by Health Canada or there would be a general media alert such as there was after a number of people died due to Seldane. A general media alert, which would be a real and useful warning but obviously reduce sales is what Wendy Arnott, Linguistics VP at Janssen-Ortho and her colleagues at the other drug companies spend most of their efforts trying to prevent. Our family doctor testified on the stand that he gets 100 pages of information a day and can’t possibly keep up. Health Canada is well aware if this (November 1998 Expert Advisory Meeting on Pharmacology Meeting notes quote above) yet have done nothing to provide a way to differentiate between urgent safety messages and those of lesser urgency.
Health Canada - Janssen-Ortho’s "best customer".1. With regards to prescription drugs, Canadians would be safer if Health Canada did not exist. The very existence of Health Canada provides a false sense of security to patients; yet officials refuse to act when lives are at stake. We would be safer if we had a few people in a room with some fax machines simply duplicating FDA orders. Wendy Arnott VP at Janssen-Ortho described the drug companies as Janssen-Ortho’s "best customer" and "partners" on the stand at the inquest. From everything I have seen and learned I have no doubt this it true. Lets be very clear and fair. Wendy Arnott’s job is to sell more drugs. The president of Johnson and Johnson’s job is sell more drugs and raise the stock value. Health Canada’s responsibility is to protect Canadians by ensuring prescription drugs are safe and effective. The goals are not compatible; the potential for conflict is high. Unfortunately the elected government in Ottawa has seen fit to coerce Health Canada officials to "partner" with the industry. Incredibly, this relationship includes secret meetings where no minutes are taken. The drug companies pay hundreds of thousands of dollars to Health Canada to get drugs approved and no doubt use these meetings to advance the supplier/client relationship demanding "better service." Hence the "best customer" description. This can mean faster drug approvals amongst other things where a possible conflict exists in the role of the truly objective regulator. I have yet to meet anyone who will publicly declare this possible conflict of interest to be appropriate, yet it is the norm and it is killing Canadians. In January 2000, the FDA finally ordered Johnson & Johnson to send a faxed letter to every doctor in the U.S. ordering that Prepulsid should not be administered unless and until they had done an EKG on the patient. Too many people had died. Health Canada dragged their feet and delayed ordering the issuance of this same warning until late in February. I have obtained the email correspondence between Marta Caris, Acting Director, Bureau of Pharmaceutical Assessment, since moved from Health Canada and Wendy Arnott VP Regulatory Matters and Linguistics for Janssen-Ortho during that time. It reveals "negotiations’ over the fine print and placement of words in a letter to be faxed out to doctors. Quote: The Canadian Medical Association Journal, Editorial, May 1, 2001 in reference to Vanessa’s death. "This is not the first time we have observed Health Canada’s advisory and regulatory actions lagging behind the FDA. But this is the last time we will merely observe. Hence forth we will ( ) monitor FDA physician advisories and inform Canadian physicians through this journal of any warnings of serious adverse drug reactions issued by the FDA." 2. Health Canada officials know they receive only a small fraction of adverse reaction reports from doctors, and that therefore the warnings published on drug monographs and labels are very misleading. They provide a false sense of security to patients, doctors and pharmacists who rely on these figure is determining the safety of the drugs. They know they don’t know when problems arise, yet they’ve done nothing substantial to make the system safer. 3. Since Vanessa’s death, the government of Canada has done nothing substantial to address drug safety. This most recent announcement would be comical if it weren’t so sad. The press release is chock full of verbs like "realign" and "coordinate" - government speak for doing nothing. They have thrown in medical devices and drugs for pets and farm animals into the mix. ' Most important, Health Canada took the word "protection" out of the Health Protection Branch two years ago, renaming it the Therapeutics Products Program. 4. Health Canada is underfunded and can’t begin to provide the level of safety the public deserves and believes they are getting. It has been permanently compromised through political interference and coerced into playing a role which is contrary to the public interest. In 1997, its budget was slashed, an action from which it has never recovered. What the government will find is that drug safety could pay for itself. It is difficult to estimate the costs related to the medical care required to deal with the fallout from hundreds of thousands of adverse drug reactions. It is certainly in the billions. On Tuesday of this week a study was published about seniors who fall in their own homes and suffer injuries. A key reason they take falls is drug reactions. We know one out of four seniors in hospital is over-medicated. The cost of otherwise unnecessary hospital care for thousands of seniors at over $ 1000/day per bed must be astronomical. Recommendation # 3: An arms-length Drug Safety Agency should be established to become a key partner in an integrated health care system providing far better outcomes for patients and costs much less. It should report to Parliament and be responsible for all aspects of drug safety, including issuing proper warnings to patients in plain language, media alerts, recalling drugs, tracking and reporting on adverse reactions and investigating deaths due to drugs; and have an adequate budget to do so. The agency should report to Parliament like the Aviation Safety Board, not like the Ethics Advisor who meets the Prime Minister in secret. The Swiss Air 111 investigation was conducted by The Transportation Safety Board, not the people who manufactured the aircraft, and not the people who approved the plane to be flown in the first place. 5. Health Canada covers up its own mistakes and those of others. In 2000 a staff pharmacist at Joseph Brant Hospital in Burlington compiled a report on ten intensive care patients who were given Prepulsid in hospital over two year period. She provided that report to Health Canada shortly after Vanessa died which concluded that seven out of nine patients were given the drug inappropriately (contraindicated) and all died. Health Canada would not release this report for over a year and half and when asked about it on the stand at the Inquest into Vanessa’s death, HC representative Dr. Brian Gillespie told the jury that he had asked for more information from the reporter and did not get it. They did get more information, and the Coroner for Halton Region is currently investigating the role of Prepulsid in these deaths. The report was only released by Health Canada when it was requested through the Freedom of Information Act by the Canadian Medical Association Journal. 6. Drug approvals at Health Canada are in overdrive, while safety is in low gear. Since the fast track approval of drugs to treat AIDS, Health Canada’s "partners" in the drug industry have put increasing pressure on elected officials and bureaucrats to get all drugs approved faster. We have no objection to potentially life giving drugs being fast tracked as long as those who are taking them have made informed decisions with regard to the risk they are taking. However, we object to fast track approval for drugs that like all drugs may carry risks designed to treat non-life threatening conditions like heartburn. Recommendation # 4: Due to the inappropriate relationship between Health Canada and the drug companies, including secret meetings where no minutes are taken, an inappropriate buyer/seller relationship, and political interference, all of which are killing Canadians, we recommend a full, Public Inquiry into the relationship between Health Canada and the major drug companies to identify the problems, conflicts of interest, and to help create a superior safety regime in a New Drug Safety Agency. Recommendation # 5: Patient information leaflets should be written and produced by an Independent Drug Safety Agency under the auspices of The Government of Canada. They should be produced in coordination with the latest and best information from other jurisdictions world wide, and state up front in plain language and in bold print:
We believe this recommendation will not only save lives, but save our health care system billions of dollars in drug costs, in unnecessary hospital stays, and costs of care and treatments from adverse reactions. ________________________________________________________________________ Conclusion We respectfully ask you to be bold. We ask you to break the silence. Your actions will address this outrage and help end it once and for all. You will be on the side of the angels. ________________________________________________________________________ The Role of a new Drug Safety Agency
Critical: This agency must have an adequate budget to meet the above mandate.
*Prepulsid is the Canadian name. Propulsid is the U.S. name. |
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