nothing says you support the troops...
like testing drugs on them...

Actually it's our government that's experimenting on our troops.

It's ongoing. They are seeing what happens to the wounded vets who are little more than vegetables (traumatic brain injuries) and ignoring the cost to the US economy as we try to take care of 1,000s of these folks.

Then there's Depleted Uranium....a huge experiment.

Chantix is the least of our worries.

This slimefest of a presidential administration just can't end fast enough.

folks, the VA is doing their job.

The patients should have been given the known information about these drugs before they agreed to be part of the studies. The story seems to be saying this information wasn't disclosed in the case of Chantix. This may be a case of bureaucratic foul up- it simply isn't clear in the story.

On the use of subjects with these disorders- it isn't unethical in a general sense. Drugs that affect psyche have a good purpose, and you can only learn the adverse effects through actually dosing people through a range of normal to less-than-normal. One does, however, need to admit patients on a one-by-one basis. Inevitably, you will have accidents- it is part of the process. Clinical trial subjects do suffer harm from the test drugs occasionally.

WTH, Kevin (and the other commenters blaming the government)?

You're taking a story in the Washington Times seriously? Not looking even a bit under the surface to figure out what the real agenda is?

What's going on here is crystal-clear. The VA, as it should, is studying how to treat PTSD, using consenting patients. No surprise, no scandal, no big deal (although maybe they should have worded their letters more strongly).

Something went wrong in one of the trials. The Washington Times jumped all over it for the following reason:

The VA is probably the best argument liberals have for single-payer. By and large, when Congress adequately funds it, it's a competently run and effective national health care system.

Making the VA look bad is one of the easiest possible ways to discredit more general nationalization of health care. Conservatives, including those who run the Washington Times, are beholden to health insurance companies who don't want to lose their profits -- earned at the expense of ordinary health-care-seeking citizens.

I'm surprised your post didn't see right through this tripe.

The problem is - they don't really know what PTSD is, no less how to treat it. Do neurons fire in the brain at "inappropriate" times? Which ones? Why? Is it brain chemistry? Is it brain damage?

Drugs are the appropriate starting point for this treatment, but it's an incredibly inexact science - a blunt instrument if you will. (Sort of like the military itself.)

Many antipsychotics and antidepressants can have these effects. From Kevin's synopsis, it doesn't appear to me that the VA is being any more irresponsible than your average hospital.
Could they do better? Oh hells yes. But this isn't any worse than what happens to your average American.
Of course, your average American hasn't been getting shot at and facing IEDs for the last XX years.

Washington Times as source aside (with Kevin indulging his once-a-day addiction to linking to some conservative nutbarrery), there's been enough adverse reactions to Chantix already reported that I don't get why the VA was experimenting with it.

Kevin,

One big question. What does Chantix have to do with PTSD? OK, so smoking may increase stress level a bit (or not) but as far as I can tell from googling it has no dual use as being therapeutic for PTSD. In the particular case of Chantix, the FDA/Pfizer/VA were using returning vets, many with PTSD, as guinea pigs without giving appropriate warnings about possible side effects. So I disagree with your thesis that this had anything to do with finding an appropriate treatment for PTSD.

(it warns of "anxiety, nervousness, tension and depression," but doesn't mention suicidal thoughts)

SG, smoking-related illnesses are sufficiently widespread and costly that it makes sense for the VA to at least be looking into drugs that can help smokers quit.
That said, I have to question the judgment of people who will offer drugs with the warnings above to a population that has a high likelihood of suffering from PTSD.

I'm having a hard time figuring out if this story has uncovered something genuinely troubling, or if it's a trashy piece of sensationalism.

The answer is "genuinely troubling," Kevin. The veterans involved in the study were not informed of known risks in a timely manner. (There's no such thing as "only" three months when you're taking a potentially harmful drug!) So much for informed consent.

As appalling as this story is the fact that you have ads on this site for Ann Coulter's free emails makes me want to poke myself in the eye for even looking at it.

Kenga,

Seems to me it's the responsibility of the drug companies and the FDA to conduct clinical trials that prove effectiveness, and not a health care provider who doesn't have the experience or, as someone mentioned upthread, the individual patient oversight necessary for drugs with potentially dangerous side effects.

What is ABC News doing sharing bylines with the Washington Times?

The Pfizer website for health care professionals reports that in 4500 patients treated during all clinical trials (450 for at least 6 months), "The most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, sleep disturbance, constipation, flatulence, and vomiting."

However, during the clinical trials there were rare reports of suicidal ideation, and after the drug was approved "There have been reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix." The site specifically warns docs to "Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately" if their patients experience any of the above.

Note that these warnings and reports all refer to patients attempting to quit smoking. I don't know the exact timeline, of course, but the occurrence of psychiatric side effects during both pre- and postmarketing for smoking cessation strongly suggests that this information was available to the VA. If so, the VA was at fault (if not blatantly negligent) in using a psychoactive drug with this kind of potential on PTSD patients. Moreoever, the drug's mechanism of action (blocking the ability of nicotine to make you feel good) certainly does not seem to lend itself to treating patients with acute anxiety, flashbacks, etc.
Claire

The last time I looked only a Medical Doctor can prescribe drugs, so any talk about the "VA" is misplaced.

Also, as far as I know, it is legal for Doctors to prescribe medications for uses beyond what they have been tested for.

While it is correct that the FDA should conduct any clinical trials of a drug I don't think it is illegal for a Doctor to try a drug out on a patient.

What is missing from this story is all the important details about whether this was some kind of controlled study or whether it was conducted by individual Doctors.

The problem here is that the article conflates "experimenting on the soldiers" with consent-based, clinical trials. These are VERY different. In clinical trails there is consent and disclosure, and if you have ever been in a clinical trial, you know it is extensive. Further, there is an Institutional Review Board established to review and deal with all ethical issues. Finally, in clinical trails, the subjects are allowed to withdraw from participation in the study at any time.

In this case the VA says the IRB was too slow. It looks like they probably were, but they also had little reason to believe that a drug that had already under gone fairly extensive trials required expedited action.

I think the VA is doing their job. Actually, I would certainly trust the VA in the design of the clinical trials over pharmaceutical companies that often tend to cherry-pick to get their drugs approved. BTW, there are 52 different clinical trials at various stages of completion with regard to the subject drug:
http://clinicaltrials.gov/ct2/results?term=Chantix

nepeta, you'll get no argument from me in re: who is responsible for establishing the safety and effectiveness of drugs.

I'm just suggesting that the population that some doctors at the VA chose to participate was a bad choice given their possible PTSD, and the noted side effects - many of which were already known - of the particular drug.
I think it in part goes to what Tripp mentioned about off-label use of the drugs, and another part to the lack of experience with the drugs and insufficient resources for individual patient oversight.

I think the REAL real story behind all of this is probably how much in the way of freebies Big Pharma doled out.

Uhh, Kevin, 21 vets claim some side effect from Chantix:

http://www.washtimes.com/news/2008/jun/16/more-about-drug-testing-military-vets/

The real problem with the Washington Times AND now ABC reporting on the issue is they're just focused on Chantix. How many other drugs have been tried and what are they?

" What does Chantix have to do with PTSD? OK, so smoking may increase stress level a bit (or not) but as far as I can tell from googling it has no dual use as being therapeutic for PTSD."

It's gonna be hard to find that out without doing the studies, frankly. PTSD victims aren't going to be a statistically significant portion of the population to be able to infer efficacy against PTSD without specific studies. I haven't seen the primary literature, but possibly anecdotal off-label use or chemical relatedness to another drug with PTSD efficacy were the reason for investigating Chantix.

As said above, I'd trust the VA's conduct of a clinical trial above that of a pharma company, cf. the recent drug trial in the UK which almost killed seven previously healthy volunteers.

The VA was doing its job here.

I'm a psychiatric nurse practitioner (and a psychologist), and I prescribe many psychiatric medications. (Your previous commenter who thinks only MDs can prescribe is way behind the times.) The potential for Chantix to cause mood changes and suicidal thoughts is well-known, and should have been disclosed. I've never heard of it causing psychosis. As others have already pointed out, it's an anti-smoking medication, not a medication for mood disorders or anxiety or PTSD. (Full disclosure: I work exclusively with children and have never prescribed Chantix.) The potential for anti-depressants (which are often used as an adjunct treatment for PTSD) for causing similar changes, particularly among young people, is also very well-known and should always be disclosed. The bigger problem with the VA and this issue is that the most effective treatments for PTSD aren't medications at all, but rather exposure treatments such as EMDR. The VA isn't providing nearly enough access to providers trained in these treatments, and that's what should really be the issue.

Yes, Kenga, we agree. And Doc at RS, I couldn't agree with you more about drug companies often neglecting to report on serious side effects. The FDA is not much of a watchdog either since its budget is almost totally dependent on drug company money.

Becky, Thanks for your excellent comment. I assume that indeed PTSD is not a totally unstudied illness since it must exist in the general population (as a result of traumatic life experiences) as well as in the veteran population. Treatments for psychiatric illness, particularly of the anxiety/depression variety, seem to be almost as individual-dependent as there are patients. I totally agree that what is needed and isn't being provided is individualized treatment, although that's only an assumption on my part.

I used to work at (did an internship there)the VA. They experiment on people allthe time and alot of the drs. aren;t even licensed to practice med. outside the VA system. I could go on & on , but i am ready to fall asleep--I've been on this damn thing for 5 hrs. trying to fix the toolbar! Maybe I'll come back tomorrow??

Kenga, dunno what the official FDA black box sez; the real world sez Chantix can cause suicidal ideation.

And, the VA was specifically using Chantix in this case as a possible PTSD treatment.

Uhhh, how effing hard is that to underdstand?

Becky and Nepeta, as someone diagnosed with PTSD myself, agreed. I am on a low level of an anti-D right now, but know that talk therapy is an important part of the process. EMDR may help, but I'm enough of a scientific skeptic to question the stronger claims for it.

Here’s my more skeptical take than Kevin’s.

Wrong URL. Try this.

Don't know if the patients were informed they were testing the drug, thus side effects unknown, or were given a known drug with side effects, in which case they should be told possible side effects. We also need to look at whether this rate of suicide in vets with PTSD is actually demonstrably outside the norm. I don't think when it only happens to one person, you 've got ehough proof, though certainly reason to provide warnings. I wish that things like this came with an "antidote." Most anti-depressants --- the SSRIs --- come with a warning nowadays that they can cause depression in some people. Hell, vicodin, a painkiller, sent me into a fullblown panic attack when a nurse injected it in me after I asked her for something for nerves. They shot me full of benadryl until it wore off. Having access to something that will reverse the side effects rapidly, instead of vague "discontinue use" or "consult a doctor" instructions on a long sheet of paper that can produce anxiety simply in reading it, would help a lot of people.

nepta,

The FDA is funded by Congress, not the pharmacutical companies (although I suspect that in this corrupt administration that some of the political appointees might be.) They set the rules for experimentation and monitor but are not doing the actual studies.

In this case it seems to be the kind of study that physicians can trust, a multi-center probably university based study not funded by Big Pharma. In fact, BP hates this kind of study because they have no control over the results and cannot quash the information if it is negative.

There are over a 1000 patients in this multi-arm study on smoking cessation. The Chantix arm was one small one. It is not clear if the study is a blind study or an open study (every one knows what the pill is) but one thing a study like this does is to verify or prove false the anectodal evidence out there. This may be the reason that the IRB allowed the study to proceed - to see if there is an increase in the incidence of mania or depression as has been reported. The FDA warning was based on such anecdotes.

I am a psychiatrist and I happen to believe the anecdotal evidence. Had I been on the IRB, I would have had grave reservations about using this drug without safeguards. Nonetheless, they may have been in place and we don't have the evidence yet that the drug caused this particular patient's problems (I strongly suspect that it did, but the there is no evidence, for now.) Once this study is published, it may show a higher incidence of "switching" in the test subjects who took the drug.

One of the problems that the current rules for vetting a drug has is that usually only about 4000-6000 patients are exposed to the drug before it goes on the market. Only after a million or so patients have been exposed will you see some of the rare side effects (which switching probably is) meaning fewer than 1%of the patients show a significant side effect not seen in the placebo group. 6000 patients is not enough to determine this.

Multi-center studies like the VA studies are considered the gold standard in treatment. The VA has a very good reputation in parsing out the crap that Big Pharma puts out and finding the best practice for a variety of problems. In this case there may have been some problems with the IRB whose job is to make sure that the medication is safe in the population being studied. This was only one case (and 21 other complaints of side effects.) It this is an open study, then there should have been more diligence, but the incident reported may or may not have been due to Chantix (as I said, though, it is very likely.) apparently the IRB did act. Had this been a life threatening rash, I doubt that the Washington Times would have reported it, but it would have been just as significant.

I am a veteran, I am very critical of the way vets have been treated in the past and present and have worked at university based VA hospitals. In general these studies are very good and do a lot of good. In this particular case there may have been problems, but overall it is probably a good study, mostly because those who are running the study are not in the political end of things.

There you will find appointees who don't believe that PTSD exists, who want to cut the budget, who are not advocates for the veteran or are complete incompetents (think FEMA.) The very justifiable complaints agains the heart of the system (the Republican Party appointees) drives a lot of the bitterness that vets show towards some of the bad things that go on. If it were up to me, I'd have free medical care for all honorably discharged vets the way my dad did.

mikeyes,

Thanks for your comment. I agree that the FDA is 'supposed' to be funded by the US government, but since the early 90's has been charging user fees to pharmaceutical companies which account for most of the FDA's budget now:

"In 1992, Congress authorized drug companies to pay user fees directly to FDA to help underwrite the cost of drug approvals. With congressional funding for FDA on the decline, the agency has become increasingly reliant on drug companies to fund the drug approval process. At minimum, this arrangement gives the appearance of a conflict of interest that can harm public trust in FDA approvals. Drug-approval scandals over the last few years, however, such as the highly publicized Vioxx scandal, have raised troubling concerns that the agency spends much more time and resources approving drugs than testing their safety."

FDA Negotiates Increase in Drug Company User Fees

Second point: So is it definite that this was a test to prove the effectiveness of Chantix as a smoking cessation aid and not a test of Chantix as a possible treatment for PTSD? On the face of it, I can't imagine that Chantix would be in that drug category. Kevin seems to state that it was being tested for PTSD therapeutic value. (Sorry, I didn't read more than two paragraphs of the WT article. I'll do that as soon as I finish this comment).

It's good to hear that you, as a physician, find VA drug testing to be unbiased and of value. I guess my question is why do universities and the VA do drug testing in the first place? A lack of trust in BP testing? A lack of trust in verification of that testing by the FDA? The ability to test the particular drug on larger populations?

I've had personal experience with some of the craziness having to do with drug 'warnings.' I won't go into the details, but will just say that I got my elderly diabetic friend off Rezulin (because of her physical complaints and high liver function tests) about 6 months before Rezulin was withdrawn from the market because of the high incidence of liver damage. I read the little drug company insert with the fine print that you need a magnifying glass to read and discovered that lab rats overwhelmingly showed liver damage in the drug tests. When I mentioned this to her doctor he replied that those were rats, not humans. (If no one is going to take the test results on rodents seriously, why torture them?) Anyway, my friend died of liver cancer shortly thereafter. I doubt that Rezulin caused the cancer but do think it was probably implicit in speeding up the process. I mention all of this only to point out that common sense should be a part of any drug testing or drug approval scheme. Giving vets with PTSD a drug that has, even anecdotally, been reported to cause mood swings and suicidal ideation, is not only lacking in professional rigor but also plain common sense. It's really almost unbelieveable to me that it was done. Actual suicide, the 'countable' result, isn't the only misfortune these vets might have encountered. Increased depression isn't negligible and in my view serves as 'pain and suffering' in itself.

nepata,

There are really two VA systems in a practical sense, those that are related to medical schools and those that are not. At one time there was also a large difference in the competence of the programs although that is not as prominent now.

The university based programs (I was involved at Tulane, Vanderbilt, and U of Kansas, Wichita) are manned mostly by half time or full time professors, residents and fellows. The full time VA doctors are usually clinical professors and often involved in research. In addition the university related VAH has other training programs such as nursing, physical therapy, etc. As a result, there are a greater ratio of treator to patient although the majority of clinicians are residents and pass through on a regular basis.

These VA/university programs are the main ones that do the multi-center studies, often in conjunction with other university programs (so they are not just the VA all the time.) Because there have been a number of very large, very well designed studies coming from the VA/university (and other VAH too), physicians look forward to the results.

On the other hand, BP funded studies are, for the most part, sales tools. I stopped seeing drug reps in 1991 after one told me that the pharm companies track my prescription practices in order to see what I was up to and then to try to change my direction or encourage what I am doing. (He didn't tell me directly, but I can read between the lines.) I am sure I have never gotten a research paper from a rep that told me his product (her increasingly) was second to another. A favorite trick is to compare the new product against one that has the highest side effect profile. Usually the two medicines are equally competent in dealing with the main illness, but you are implored to try the new one because it has less of a side effect somewhere even if it is 50 times more expensive.

The VA studies along with other multi-center studies (even the ones that are sponsored by BP) tell a more balanced story. For one thing they have a much larger number of subjects which allows for greater reliability and better statistics. It is those studies that reveal that some standard practices are more harmful than helpful and show the way for better care.

For example, a recent very large study under NIMH auspices that looked at depression showed that there is very little difference between anti-depressants as far as efficacy goes and that certain generic versions are prefered due to a low side effect profile. It recommends that you start with one of the $4 (at Wal-Mart or Target)drugs and go on from there.

Most of this was already known on an anecdotal basis, but it is hard to argue against a study with thousands of subjects. While the study has some flaws, the results are very helpful.

By the way, the universities are involved in research because that is what universities do - extend knowledge. One of the real benefits of these kinds of studies is that each group involved not only contributes to the overall answer to the question asked, but they also look at smaller questions within the study. Because there are thousands of subjects and millions of points of data, a professor or resident, even a medical student can take the information and apply it to another related question. This information can lead to other inquiries. These analyses are cheap because the expensive part has already been done for the original project. The rest of the cost is the time of the researcher. Sometimes these studies yield more new information thant the original study.

Mikeyes (or anon?),

Thanks for the info on the VA/med school connection. Just wanted to let you know that I got your reply here in the Archives. (gr)

One comment, though, that I can't resist making in response to:

"a recent very large study under NIMH auspices that looked at depression showed that there is very little difference between anti-depressants as far as efficacy goes"

NIMH is kidding, right? So I spent twenty years of my life taking benzodiazepines and trying practically every anti-depressant in the PDR for my atypical depression/panic syndrome for no reason? Finally a psychiatrist was brave enough to trust me with an MAOI (Nardil), despite its notorious food/drug interactions. I've now enjoyed nearly twenty years of depression-free and '90%' panic-free living. I can only say from my experience and those of friends and relatives that have suffered with depression that the search for an effective anti-depressant is often a long one. This includes the newer class of SSRIs and SNRIs as well. The only way I can interpret the NIMH result is that for ALL patients ALL anti-depressants are equally semi-effective. Anyway, the NIMH result sure flies in the face of tons of anecdotal evidence to the contrary, don't you agree?

.
No matter who reported this, or why, the facts remain:

1. No informed consent. Even in the 3-months-too-late notice sent to Vets in the study, there was no mention of suicide.
2. VA doctors continued to use a drug on suicidally-inclined patients after they knew it could lead to suicide.
3. The drug is STILL being given to veterans with PTSD.
4. Veterans groups, Democratic & Republican Congressmen and Barack Obama have expressed outrage and demanded answers, and an end to this experiment.

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