‘Lab Rats At $30 A Month:’ The VA And Chantix
16 CommentsBy Ed Silverman // June 17th, 2008 // 3:14 pm
The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, according to an investigation by The Washington Times and ABC News.
In one such experiment involving Pfizer’s controversial anti-smoking drug Chantix, the Department of Veterans Affairs took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police.
James Elliott, a decorated Army sharpshooter who suffers from post-traumatic stress disorder after serving 15 months in Iraq, was confused and psychotic when he was Tasered by police in February as he reached for a concealed handgun when officers responded to a 911 call at his Maryland home, the Times and ABC report.
Elliott, a chain smoker, began taking Chantix last fall as part of a VA experiment that specifically targeted veterans with PTSD, opting to collect $30 a month for enrolling in the clinical trial because he needed cash as he returned to school. He soon began suffering hallucinations and suicidal thoughts, unaware that the new drug he was taking could have caused them.
UPDATE: The VA blasts the story in a statement late today as “inaccurate and misleading.” And the agency insists pharmacists and researchers were informed shortly after an FDA health advisory was issued in February about Chantix and suicide, and that payments to trial participants was appropriate.
Just two weeks after he began taking Chantix in November, the VA learned from the FDA the drug was linked to hallucinations, suicide attempts and psychotic behavior. But the VA didn’t alert Elliott before his own episode in February. In failing to do so, Elliott tells the reporters, the VA treated him like a “disposable hero…You’re a lab rat for $30 a month.”
“When you’re taking advantage of a very vulnerable population, people who have served the country, and the agency that’s responsible for their welfare isn’t putting their welfare first, that’s a pretty serious breach of ethics,” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, tells the Times and ABC.
This is a lengthy story that has two videos. Here’s the rest.
The Washington Times took the nice photo of Elliott.
James
See what happens when your beloved government is in charge of the health and safety of Americans?
Show me one pharma company that could get away with this. Everyone on this site would be screaming for the heads of execs on platters, and for the gov’t to increase regulation.
Everyone who argues for greater gov’t regulation should remember this before they come down on big, evil business. If the VA doesn’t care about their own soldiers, what makes you think the FDA will ever give a damn about you?
Jack2
This isn’t a Pfizer sponsored study in the VA population?
James
Jack2, there is nothing in the article to indicate that Pfizer sponsored it. From the article:
“The smoking-cessation study uses nicotine replacement products like gum and patches as well as Chantix - a drug that is supposed to block certain brain receptors that make smoking pleasurable. The $11 million taxpayer-funded study was approved in 2004, two years before the FDA approved Chantix for prescription use.”
Taxpayer dollars. Moreover, even IF pharma sponsored the study, the VA is the one that accepted the study and executed the protocol. Again from the article:
“While the alerts from Pfizer and the FDA clearly mentioned suicide and suicidal thoughts as possible side effects, the VA’s letter to its veterans used no such language.
‘Scientists have recently learned that varenicline can sometimes have serious side effects in some people,’ the VA letter said. ‘These side effects may include an increase in psychiatric symptoms such as anxiety, nervousness, tension and depression as well as untoward changes in behavior.’
Asked why the letter omitted the most significant side effect, Mr. McFall said ‘the more verbiage you use, the more difficult and lengthy it becomes, hard to read. It’s more likely veterans won’t pay attention to it if you overdo.’
However, a secondary research consent form sent with the letter that participants are now being asked to sign cites ‘changes in behavior, anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide.’
Mr. McFall said the serious side effects were included in the secondary consent form, and not the notification letter, because ‘it’s better to have the letter be brief” so that it is not a “burden for people who sometimes have problems reading.’ ”
It is the duty of the research site to ensure that the consent form is understood, and that all significant risks are disclosed. If someone can’t read, you have to communicate to them in language they will understand, or they should be ruled out from the trial.
The VA screwed this up big-time. Whether it was because they were too stupid or to apathetic, I don’t know.
Everyone here should be outraged by this.
Just A Thought
Lab rats, paid or not, are not heard in a timely enough manner and sometimes ignored altogether. It makes human testing, post-marketing or paid (if you want to call 30 bucks a month paid), far too risky a business. Those participating should be completely taken care of. These are multi-billion dollar companies getting something for nothing.
When the fed is involved and things go wrong, when they don’t act immediately, it makes me believe that our government finds us expendable. There is no other explanation.
Because a person has another condition the drug companies attempt to explain away their possible roles. It’s always the patient’s fault. The FDA is slower to act. Nevermind that people are being chemically altered… that couldn’t possibly be it.
We have to be more advanced than this.
I hope Mr. Elliot is alright.
war horse
There is absolutely nothing in the informed consent information about any drug treatments, alternatives, or risks. This is an essential part of any clinical trial. The only risk information given regards screening questions. This goes against all good practices for conducting clinical research.
David Hamilton
Astonishing how things are going from bad to worse for Pfizer and Chantix. Has the drug industry has ever had this many major-drug meltdowns at once?
Of course, I can’t help wondering whether Big Pharma will ever decide that maybe it ought to take toxicity reports more seriously at an earlier stage, even at the risk of a temporary setback in sales. Not only would it be good corporate citizenship, it might go a long way toward restoring the industry’s reputation and enhancing the credibility of its marketing.
More here: http://industry.bnet.com/pharma/2008/06/17/pfizer-and-chantix-from-bad-to-worse/
Jack2
I also feel bad for Pfizer. I only know what I read here and from other news sources but it sems to me that:
1. Pfizer got no signal of these psychiatric AEs in their clinical trials.
2. Once they got a sufficient number of spontaneous post-marketing AE reports, they’ve been very forthcoming with information, both in terms of speed and extent.
3. Some people are jumping to the conclusion that these spontaneously reported AEs constitute a real, confirmed signal - something very difficult to do, and, in my opinion, premature.
4. What we know for sure is that the drug does help people stop smoking - something very difficult to do - and according to the trial data it helps much more than anything else to ever come along. We also know for sure that smoking causes serious health problems.
5. So, combining 3 & 4, a patient/doc needs to weigh the known hazards of smoking against the theoretical hazards of psychiatric AEs.
…and then just a few months ago they got slammed for using Jarvik in their Lipitor ads, something that I don’t think anyone should have batted an eye over….and no, I don’t work for Pfizer.
Insider
Jack 2 - you should!
Get your resume in.
LOL
harpy
So, the study began 2 years before Chantix was approved by FDA - were they using it then? Or only after approval? And, if PTSD is considered a metal disorder of some sort, doesn’t that mean that Pfizer could have had information on how people with mental disorders might respond to the drug? That would be telling since the company is claiming they had no idea how mentally unbalanced people would respond to the drug seeing as how they are excluded from trials.
Jack2 - do you have access to the long-term efficacy data? The recidivism rate once people stop taking Chantix?
Jack2
I don’t have anything that anyone else doesn’t have. The label says:
Except for the initial Phase 2 study (Study 1) and the maintenance of abstinence study (Study 6), patients were treated for 12 weeks and then were followed for 40 weeks post-treatment….In each study, CHANTIX treated patients were more likely to maintain abstinence throughout the follow-up period than were patients treated with placebo.
Jane
Do you know if they counted the completed suicide people in that 40 week post chantix treatment group? That would skew the results a little, no?
Jack2
I don’t really understand your question. I assume it’s somewhat sarcastic. Anyway…
The threshold for the AE table was AEs with a frequency of 1% or greater, and 0.5% greater than placebo. This table doesn’t list suicide.
Later the label lists suicidal ideation as a rare side-effect. It does not define “rare.”
anon
The VA completely missed the point in their statement. The company knew (prob a long time ago), the VA knew, the increased risks of taking this drug but the patients enrolling in the study did not, according to the article. Study patients are supposed to be fully informed about the risks vs benefits a Federal Regulation.
These patients were thus coerced into a government program.
pfizer and the VA (bush administration)?
This is an example of medical research at it’s worst. What about all the other federally funded programs addiction programs.. what are these patients offered? Chantix??
This program should have been stopped until more research is completed. These are a vulnerable population with PTSD.
Once again an outrage.
Nathan
Anon writes: “The company knew (prob a long time ago), the VA knew, the increased risks of taking this drug…”
As far as I can tell, no one knew of increase risks associated with this drug until very recently! As we’ve batted back and forth on this site frequently, most side-effects associated with Chantix are also side-effects of general nicotine withdrawal. It’s only been in the last 6 months that data has emerged about more serious side effects. The jury is still out on whether those “serious” side effects are really associated with the drug or not.
anon
note the muted reponse of the main media outlets. This one involves the big guns. interesting to see what the investigation leads to. PHSHG oversee the tobacco cessation program in the VA, staff members do not identify their affiliations with drug companies.
FYI This is the fda regulation
A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.”
Nov 2007 the FDA thought it significant enough to release a warning an we all know the FDA are very relutant to upset their corporate friends. the patient had a problem in Feb 2008
VA handnook research guidelines
“Research involving subjects who are mentally ill or subjects with impaired decision-making capacity warrants special attention. Research involving these populations frequently presents greater than minimal risk; may not offer direct medical benefit to the subject; and may include a research design that calls for washout, placebo, or symptom provocation. In addition, these populations are considered to be vulnerable to coercion.
From the VA website
The Public Health Strategic Health Care Group (PHSHG) is a key organizational component of the Office of Public Health and Environmental Hazards. PHSHG’s mission is to improve the health of veterans through the development of sound policies and programs related to several major public health concerns, including: HIV infection, HCV infection, seasonal influenza, smoking and tobacco use cessation, and emerging infections of public health significance - including health care associated infections.
On December 6, 2007, the Public Health Strategic Health Care Group (PHSHG) convened the Provider Feedback Forum on Smoking and Tobacco Cessation. The primary purpose of the forum was to obtain feedback from frontline providers about their experiences in conducting smoking and tobacco cessation programs for patients receiving care from the Veterans Health Administration (VHA). PHSHG sought this input in order to help determine priority areas for ongoing and future program and policy efforts”
Same report December 2007: “The drug is on the national formulary but it is not a first-line medication and is restricted for use only after patients have failed with either the patch or bupropion. Participants noted that recently an FDA safety warning has been issued concerning varenicline and possible suicidal ideation. This is a serious concern given the population served by VHA and that participants in the varenicline clinical trials did not reflect the VA’s patient population. The VHA Pharmacy Benefits Management’s Center for Medication Safety (VA MedSafe) is collecting data on adverse events related to varenicline and has an ongoing program to monitor for safety.
Patients are requesting varenicline—as a result of direct-patient marketing; many patients are aware of varenicline and want “the pill.” However, given the safety considerations, many primary care providers are reluctant to prescribe it. ”
State programs:Another reported that the state health department provides free NRT and varenicline via a state telephone quitline.
Outrageous.
anon
Uh - this was not even a drug study. It compares tow different ways to deliver smoking cessation for PTSD patients - the usual way vs. treatment by the same team that is already working with you. Drugs are not being studied at all, although some of the subjects take these medications as part of their usual medical care.