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Woman says S.A. drug trial BMS094 damaged heart
Woman says S.A. drug trial damaged heart
By John MacCormack
Updated 10:02 p.m., Monday, August 27, 2012
A Corpus Christi woman who claims she suffered serious heart damage this summer during a hepatitis drug trial in San Antonio has sued drug manufacturer Bristol-Myers Squibb and trial administrator Alamo Medical Research.
“Janet Schaefer Vella now is in need of a heart transplant due to irreversible damage to the heart caused by BMS094,” reads the suit, which claims the drug giant rushed ahead with the clinical trials “without fully evaluating the risks and benefits of the drug.”
The product liability suit was filed Friday in Nueces County, a day after Bristol-Myers announced it was giving up on the experimental hepatitis drug, noting that one person had died and eight more were hospitalized after participating in trials.
“While the cause of these unexpected events, which involved heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interests of patients to halt development of BMS-986094,” read the company news release.
In an email, Bristol-Myers declined to comment on Vella's suit, but noted that 113 people were involved in the same trials when they were halted. In an e-mail, Alamo Medical Research referred press inquiries to Bristol-Myers.
Vella, 60, is among about 3.2 million Americans and 170 million people worldwide who are infected with Hepatitis C, which can be deadly but often lies dormant for years.
Bristol-Myers is among a half-dozen companies aggressively seeking an effective new treatment. The drug giant paid $2.5 billion earlier this year to acquire Inhibitex Inc., which created BNS-986094 and other potential hepatitis treatments.
Since halting the drug trials, Bristol-Myers has said it will take a $1.8 billion loss on the acquisition.
Her lawyers said Vella, a supervisory nurse at Bay Area Hospital, likely contracted the virus through blood transfusions decades ago, but it remained undetected.
After she learned she was infected this spring, she was referred to the drug trial in hopes of a cure that would let her remain a pediatric nurse. In June, she began taking BMS094 and a second drug daily.
“She is a nurse, so she tends to hear things accurately, and they said there was a 100 percent cure rate,” said her attorney, Robert Hilliard of Corpus Christi.
But according to the suit, evidence of problems with Vella's heart soon arose. Each time test results showed anomalies, the suit claims, doctors at Alamo Medical Research told her to continue taking the drug.
Finally, about July 28, Vella became ill while working at the hospital. Tests there revealed she was on the brink of heart and kidney failure, the suit claims.
“Janet's cardiologist called the Federal Drug Administration, and the trials stopped. I suspect she was the first to report serious problems,” Hilliard said.
He said that because Vella still has Hepatitis C, she is not eligible for a heart transplant.
“She can walk around, but when you look at her, you can see she's not well,” he said.
The lengthy consent forms signed by all the hepatitis drug trial participants described possible side effects including headaches, nausea, heart palpitations and diarrhea.
And while there is also a general warning about “risks that are presently unforeseen and unknown” while taking experimental drugs, there is no mention of possible heart or kidney problems.
http://www.mysanantonio.com/default/article/Woman-says-S-A-drug-trial-damaged-heart-3818569.php
By John MacCormack
Updated 10:02 p.m., Monday, August 27, 2012
A Corpus Christi woman who claims she suffered serious heart damage this summer during a hepatitis drug trial in San Antonio has sued drug manufacturer Bristol-Myers Squibb and trial administrator Alamo Medical Research.
“Janet Schaefer Vella now is in need of a heart transplant due to irreversible damage to the heart caused by BMS094,” reads the suit, which claims the drug giant rushed ahead with the clinical trials “without fully evaluating the risks and benefits of the drug.”
The product liability suit was filed Friday in Nueces County, a day after Bristol-Myers announced it was giving up on the experimental hepatitis drug, noting that one person had died and eight more were hospitalized after participating in trials.
“While the cause of these unexpected events, which involved heart and kidney toxicity, has not been definitively established, the Company has determined that it is in the best interests of patients to halt development of BMS-986094,” read the company news release.
In an email, Bristol-Myers declined to comment on Vella's suit, but noted that 113 people were involved in the same trials when they were halted. In an e-mail, Alamo Medical Research referred press inquiries to Bristol-Myers.
Vella, 60, is among about 3.2 million Americans and 170 million people worldwide who are infected with Hepatitis C, which can be deadly but often lies dormant for years.
Bristol-Myers is among a half-dozen companies aggressively seeking an effective new treatment. The drug giant paid $2.5 billion earlier this year to acquire Inhibitex Inc., which created BNS-986094 and other potential hepatitis treatments.
Since halting the drug trials, Bristol-Myers has said it will take a $1.8 billion loss on the acquisition.
Her lawyers said Vella, a supervisory nurse at Bay Area Hospital, likely contracted the virus through blood transfusions decades ago, but it remained undetected.
After she learned she was infected this spring, she was referred to the drug trial in hopes of a cure that would let her remain a pediatric nurse. In June, she began taking BMS094 and a second drug daily.
“She is a nurse, so she tends to hear things accurately, and they said there was a 100 percent cure rate,” said her attorney, Robert Hilliard of Corpus Christi.
But according to the suit, evidence of problems with Vella's heart soon arose. Each time test results showed anomalies, the suit claims, doctors at Alamo Medical Research told her to continue taking the drug.
Finally, about July 28, Vella became ill while working at the hospital. Tests there revealed she was on the brink of heart and kidney failure, the suit claims.
“Janet's cardiologist called the Federal Drug Administration, and the trials stopped. I suspect she was the first to report serious problems,” Hilliard said.
He said that because Vella still has Hepatitis C, she is not eligible for a heart transplant.
“She can walk around, but when you look at her, you can see she's not well,” he said.
The lengthy consent forms signed by all the hepatitis drug trial participants described possible side effects including headaches, nausea, heart palpitations and diarrhea.
And while there is also a general warning about “risks that are presently unforeseen and unknown” while taking experimental drugs, there is no mention of possible heart or kidney problems.
http://www.mysanantonio.com/default/article/Woman-says-S-A-drug-trial-damaged-heart-3818569.php
Best Answer
Tis true, these meds are dangerous. It's too bad so many people dont have medical insurance, and are forced to participate in Clinical Trials, as guinea pigs.
Didn't we have someone post a month or so ago and tell us their brother had been in a trial and lived alone and was found dead of a heart attack? I wonder if it was the same trial. At that point I had never heard of any of the drugs causing heart problems.
" I've heard of many being stopped but none that cause injuries to someone's health."
BILN2061
There used to be primate trials run in parallel to human trials, so that these things were caught before humans sustained any permanent damage. Trouble was, nothing was being approved. I haven't heard of any primate trials since BILN2061.
Aother problem is that the companies involved have decided the drug 'cocktail' approach, with cheap to produce small molecule DAAs, is the one that maximizes profit. With the exception of the IL28B, genetic testing to determine who will benefit most from which drug has fallen by the wayside. International patent law and the need to pacify stockholders means we'll probably never see anything like an effort to combine IFN alpha 2b with a branched PEG molecule like the one used with IFN alpha 2a.
BILN2061
There used to be primate trials run in parallel to human trials, so that these things were caught before humans sustained any permanent damage. Trouble was, nothing was being approved. I haven't heard of any primate trials since BILN2061.
Aother problem is that the companies involved have decided the drug 'cocktail' approach, with cheap to produce small molecule DAAs, is the one that maximizes profit. With the exception of the IL28B, genetic testing to determine who will benefit most from which drug has fallen by the wayside. International patent law and the need to pacify stockholders means we'll probably never see anything like an effort to combine IFN alpha 2b with a branched PEG molecule like the one used with IFN alpha 2a.
I was pretty surprised at how many people on the triple Tx, got such severe anemia. A guy I know who was treating recently, had his HGB drop to 6.5
Hemoglobin that low can easily cause heart problems, especially with an older person, who has other pre-existing health conditions.
But because Hep C and Cirrhosis are such a deadly combo, risks are taken.
Hemoglobin that low can easily cause heart problems, especially with an older person, who has other pre-existing health conditions.
But because Hep C and Cirrhosis are such a deadly combo, risks are taken.
i like that doc- he is probably doing the best he can- altho i have found with any medical personnel you have to be tough and assertive. they are all overwhelmed and really some of them just don't care.
the insurance industry has made medicine a blur for most and we are desperate for the cure....
i think more onus on the drug companies- altho if he ignored heart problems for real- that's not good. we HAVE to demand proper attention when dealing with these drugs.
if BMS hadn't been so intent on making their own drug, when one was already working (7977), it kinda makes you wonder.
this issue in the world of medicine is bad and likely to get worse before better.
the insurance industry has made medicine a blur for most and we are desperate for the cure....
i think more onus on the drug companies- altho if he ignored heart problems for real- that's not good. we HAVE to demand proper attention when dealing with these drugs.
if BMS hadn't been so intent on making their own drug, when one was already working (7977), it kinda makes you wonder.
this issue in the world of medicine is bad and likely to get worse before better.
In fact, I just noticed a member here, "dointime" who was rendered tolerant to Teleprevir, in a Vertex Trial, because she got the Teleprevir with no riba arm~
Thank you for posting that imfo about reasons for being in the Trials.
I do realize many of us have medical insurance, (myself included) and that they participate in Trials, for diiferent reasons, then "not havingmedical insurance".
But it does sadden me, when I meet a person with Hep C, who doesn't
have Medical Insurance, and they are unable to get a liver biopsy.
I do usually suggest that they try a Clinical Trial, because it is better than doing nothing.
My husband has a fear that he may develope a tolerance to one of the drugs, during a Trial. Like, suppose someone had been in a double blind test, for Triple Tx, and had recieved Victrelis without Inf and Riba...this could have rendered them PI tolerant~ Again, this could happen, while they are testing the new generation of PI"s, perhaps?
I do realize many of us have medical insurance, (myself included) and that they participate in Trials, for diiferent reasons, then "not havingmedical insurance".
But it does sadden me, when I meet a person with Hep C, who doesn't
have Medical Insurance, and they are unable to get a liver biopsy.
I do usually suggest that they try a Clinical Trial, because it is better than doing nothing.
My husband has a fear that he may develope a tolerance to one of the drugs, during a Trial. Like, suppose someone had been in a double blind test, for Triple Tx, and had recieved Victrelis without Inf and Riba...this could have rendered them PI tolerant~ Again, this could happen, while they are testing the new generation of PI"s, perhaps?
That's the clinic I've been going to, different trial, though. I'm in the Gilead, got my final visit at the end of the month.
They fixed me, I have nothing but good to say about them. That's on the drug company, not the clinic.
They fixed me, I have nothing but good to say about them. That's on the drug company, not the clinic.
"It's too bad so many people dont have medical insurance, and are forced to participate in Clinical Trials,"
All one needs to do is read here, there are many people that has insurance that are into to trials, I for one was one of those people for different reasons... Thats far from the number one reason
All one needs to do is read here, there are many people that has insurance that are into to trials, I for one was one of those people for different reasons... Thats far from the number one reason
I suspect this person being a nurse had insurance. I did have and still have medical insurance - this wasn't a factor when I agreed to a trial.
I remember signing consent for the trial I entered - even death was mentioned as a possibility. Trials are filled with unknowns.
Actually that's the first I've heard about clinical trials having problems this serious. I've heard of many being stopped but none that cause injuries to someone's health. It's quite a huge lawsuit. My thought is anyone in that trial could get some amount of cash for their trouble and possible future difficulty. This ***** but I hope all people who have difficulties as a result of that clinical trial are able to collect.
http://thomasjhenrylaw.com/practice-areas/drug-recalls-and-pharmaceutical-litigation/daclatasvir-and-bms-986094/
http://thomasjhenrylaw.com/practice-areas/drug-recalls-and-pharmaceutical-litigation/daclatasvir-and-bms-986094/
".......serious heart damage this summer during a hepatitis drug trial.......rushed ahead with the clinical trials “without fully evaluating the risks and benefits of the drug......... unexpected events, which involved heart and kidney toxicity.......there is also a general warning about “risks that are presently unforeseen and unknown” while taking experimental drugs......"
This all sounds way too familiar. It's just some of the reasons that pressuring drug companies and governmental agencies to speed the approval process or try the drug combos 'we' think they should try doesn't really make sense.
This all sounds way too familiar. It's just some of the reasons that pressuring drug companies and governmental agencies to speed the approval process or try the drug combos 'we' think they should try doesn't really make sense.
Thanks for posting. I like the or should say, don't like, the statement: 3.2 million Americans and 170 million people worldwide who are infected with Hepatitis C, which can be deadly but often lies dormant for years. Matbe I'm being too nit picky, but...
Often lies dormant? I know the journalist is not an HCV expert, and maybe he meant the symptoms don't appear for years, but please get the real facts straight before writing a story.
Often lies dormant? I know the journalist is not an HCV expert, and maybe he meant the symptoms don't appear for years, but please get the real facts straight before writing a story.
I know. I hear this from so many people. It looks like you found an excellent doctor so I am very relieved for that. I started going there when it was a small clinic and I have sort of grown with them. It saddens me sometimes I hear certain things about them. There is lots of positive and I feel an incredible sense of loyalty to my Doctor - plus I trust the guy and his staff. For some reason we click. Sadly I do not foresee that happening for many people and to my great shame I am often at a loss when someone asks me for a referral.
I did not realise I was supposed to select an best answer - thank you both for responding. I suppose I had never considered any possible downside to a clinical trial. I wasn't trying to be Debbie Downer with this post or anything.
I am glad both you an Bo are doing OK and not in this boat!!
I did not realise I was supposed to select an best answer - thank you both for responding. I suppose I had never considered any possible downside to a clinical trial. I wasn't trying to be Debbie Downer with this post or anything.
I am glad both you an Bo are doing OK and not in this boat!!
It gives one pause, doesn't it?
I had contacted them once thinking of treating there. There were some things I was not enchanted with and never filled out the forms.
That is a good treatise on the good and bad things about trials. Thank you for posting.
bean
I had contacted them once thinking of treating there. There were some things I was not enchanted with and never filled out the forms.
That is a good treatise on the good and bad things about trials. Thank you for posting.
bean
The poor woman. That’s very quick, too, just since June…a couple-three months. Alamo Medical Research is affiliated with the clinic I go to (The Digestive Disease Centre)
______________________
Understanding Clinical Trials from Clinicaltrials.Gov
http://clinicaltrials.gov/ct2/info/understand
______________________
The Benefits of Participating in Clinical Trials
If you have a disease that cannot be treated with an existing drug or regimen, participation might provide you with a successful treatment before it becomes available to others.
If you are debilitated in some way, you may have the opportunity to test a regimen that would improve your quality of life.
If you are qualified to participate in a study for a particular disease or condition, and you have had trouble finding good care for your disease or condition to that point, you may find access to improved care since the investigators involved in the study focus directly on the medical problem being studied.
The drugs and protocols offered during clinical trials are often provided at no cost to participants. Patients who have trouble affording the drugs or treatment they need may consider enrolling in a clinical trial in order to access the protocols that may help them.
Some patients have no alternatives for treatment and permanent debilitation or death are imminent. In such cases, participation in a clinical trial may give them hope or possibilities that do not exist otherwise.
You may have interest in the humanitarian reasons to participate. For example, many drugs, devices and therapies have previously been tested on white men, and found safe and useful. Fewer trials have been designed and run for women, minorities, or children. Participation in a trial that broadens the use of a good drug for one of these less-tested groups is useful to humanity.
Perhaps you are just curious about a treatment possibility and fit the profile needed for the trial.
The Risks of Participating in Clinical Trials
Patients do not know whether they are receiving the experimental drug or treatment, or a previously approved drug or treatment, or even a placebo (a dummy treatment.) Therefore, if the reason you decide to participate is because you hope to try a treatment that is not yet publicly available, you usually have, at best, a 50% chance of receiving that treatment.
There may be side effects or outcomes that are unpleasant. They may last only a short time, or they may affect you for the rest of your life.
The treatment being studied may have no positive effect, either because you aren't really receiving the treatment being studied (see above) or because the treatment isn't appropriate to help you.
The time and attention required of participants may be long and involved. It may require hours of testing, miles of travel, hospital stays or complicated dosing.
New doesn't always mean better.
Not all clinical trials are as objective as they need to be. Ideally they are set up to be totally objective, but patients are wise to look at who/what organization is doing the investigating to be sure the study is not biased by financial gains that can be made from any specific outcome.
For example, a drug manufacturer may have developed a new drug for asthma. It may set up a clinical trial that compares its new drug against a drug already being sold by its competitor. Smart patients and their doctors know to look at possible bias in these kinds of results since proving the new drug is better will clearly reap profits for the manufacturer of the new drug.
How to Weigh the Risks and Benefits of Participating in Clinical Trials
In order to participate in a clinical trial, you must be deemed eligible to do so by a number of criteria. Once you know you are eligible, and you've considered the risks and benefits above, you will want to ask a number of questions of your doctor or the investigators to determine whether participation is worth your effort.
Once you are satisfied with the answers to the questions and others you may think of, you will be ready to decide whether you want to participate in the trial.
Informed Consent
Before you are allowed to participate, you will be asked for your informed consent which indicates you understand the answers to your questions and accept the terms of the trial.
http://patients.about.com/od/clinicaltrials/a/trialrisksbenes.htm
______________________
Understanding Clinical Trials from Clinicaltrials.Gov
http://clinicaltrials.gov/ct2/info/understand
______________________
The Benefits of Participating in Clinical Trials
If you have a disease that cannot be treated with an existing drug or regimen, participation might provide you with a successful treatment before it becomes available to others.
If you are debilitated in some way, you may have the opportunity to test a regimen that would improve your quality of life.
If you are qualified to participate in a study for a particular disease or condition, and you have had trouble finding good care for your disease or condition to that point, you may find access to improved care since the investigators involved in the study focus directly on the medical problem being studied.
The drugs and protocols offered during clinical trials are often provided at no cost to participants. Patients who have trouble affording the drugs or treatment they need may consider enrolling in a clinical trial in order to access the protocols that may help them.
Some patients have no alternatives for treatment and permanent debilitation or death are imminent. In such cases, participation in a clinical trial may give them hope or possibilities that do not exist otherwise.
You may have interest in the humanitarian reasons to participate. For example, many drugs, devices and therapies have previously been tested on white men, and found safe and useful. Fewer trials have been designed and run for women, minorities, or children. Participation in a trial that broadens the use of a good drug for one of these less-tested groups is useful to humanity.
Perhaps you are just curious about a treatment possibility and fit the profile needed for the trial.
The Risks of Participating in Clinical Trials
Patients do not know whether they are receiving the experimental drug or treatment, or a previously approved drug or treatment, or even a placebo (a dummy treatment.) Therefore, if the reason you decide to participate is because you hope to try a treatment that is not yet publicly available, you usually have, at best, a 50% chance of receiving that treatment.
There may be side effects or outcomes that are unpleasant. They may last only a short time, or they may affect you for the rest of your life.
The treatment being studied may have no positive effect, either because you aren't really receiving the treatment being studied (see above) or because the treatment isn't appropriate to help you.
The time and attention required of participants may be long and involved. It may require hours of testing, miles of travel, hospital stays or complicated dosing.
New doesn't always mean better.
Not all clinical trials are as objective as they need to be. Ideally they are set up to be totally objective, but patients are wise to look at who/what organization is doing the investigating to be sure the study is not biased by financial gains that can be made from any specific outcome.
For example, a drug manufacturer may have developed a new drug for asthma. It may set up a clinical trial that compares its new drug against a drug already being sold by its competitor. Smart patients and their doctors know to look at possible bias in these kinds of results since proving the new drug is better will clearly reap profits for the manufacturer of the new drug.
How to Weigh the Risks and Benefits of Participating in Clinical Trials
In order to participate in a clinical trial, you must be deemed eligible to do so by a number of criteria. Once you know you are eligible, and you've considered the risks and benefits above, you will want to ask a number of questions of your doctor or the investigators to determine whether participation is worth your effort.
Once you are satisfied with the answers to the questions and others you may think of, you will be ready to decide whether you want to participate in the trial.
Informed Consent
Before you are allowed to participate, you will be asked for your informed consent which indicates you understand the answers to your questions and accept the terms of the trial.
http://patients.about.com/od/clinicaltrials/a/trialrisksbenes.htm
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