Friday, January 26, 2007

Neuronetics Swings... AND MISSES!

Neuronetics' transcranial magnetic stimulation was rejected by the FDA's advisory panel today. For a couple of stories on the panel's discussion and recommendation, try here and here.

According to one report:
The majority of the panel—made up of an engineer, several psychiatrists and neurologists, and a statistician—had no problem with rTMS's risks. There are almost none. The biggest worry with it is that it might accidentally spark a seizure, but that did not happen even once out of the 155 patients treated. The problem was that Neuronetics couldn't prove any benefit. Treated patients got a little better, but so did those patients that underwent a sham treatment.
According to another source:

But the panel was generally unimpressed with the company's data, which showed a slight statistical advantage in depression symptoms over dummy therapy after six weeks of treatment. Several panelists expressed dismay that patients showed no improvement on some depression scales and only minor improvement on ones that showed a difference.

"The panel seems to be in consensus that the primary analysis did not establish efficacy," said Thomas Brott, the committee's chairman.

"Perhaps a reasonable person could question whether there has been an effect at all," said Brott, a neurologist from Mayo Medical School in Jacksonville, Fla.

The panel did not formally recommend to FDA whether or not the machine should be approved. But the agency scientists suggested at a public hearing that they were also uneasy with the company's results.

Ann Costello, an FDA medical reviewer, questioned whether the mixed evidence of effectiveness in Neuronetics' studies contained "any clinically relevant information."

Peter Lurie, deputy director of Public Citizen's Health Research Group, told the panel that Neuronetics did not show that its device was substantially equal to ECT, a standard that many medical devices must meet for FDA approval. He focused on the fact that patients actively treated with the machine showed mild improvement on only one of three depression scales.

"The magnitude of the finding is trivial from a clinical point of view," he said in an interview.

Maybe the FDA panel learned something from the VNS approval (here and here)?

6 comments:

Marissa Miller said...

Nice.

However, I'm currently in the "maybe placebos aren't so bad" stage. Why not trick someone into thinking that it'll relieve his or her depression? No side effects! Yay!

However, that sort of thing just doesn't get FDA approval. *shrugs* Oh well.

Anonymous said...

Darn, now I'm going to have to continue relying on my cell phone to stave off the blues.

Herb said...

Dear Ms. Miller,

I too am for placebos. It does tend to give the patient some relief and knowledge of what it feels like to not be depressed without any supposed side-effects.

The problem though is placebos are not long lasting that is unless it’s VNS Therapy where I’ve coined a new medical term in honor of Drs. Lurie and Wolfe and maybe I should also include doc (CL Psych), MCPEP (Multi-year Continuous Placebo Effect Phenomenon).



Anonymous,

While I am unhappy to learn that another potential treatment option (TMS) for those unique and seriously ill and disenfranchised patients has proven ineffective I am extremely happy for you.

Although your “cell phone” has never been subjected to a double-blind study to demonstrate its safety and efficacy which I’m sure doc (CL Psych) will insist upon to validate your anecdotal statement, I am very happy that you have something to rely upon to help you with your illness while others continue their search and doc (CL Psych) uncovers what he believes to be faulty data in most all studies and alleged corruptness of medical professionals and researchers and doesn’t offer up pro-active and effective alternatives.

Tearing down is in my opinion certainly easier especially with the aid of gravity than it is to be a creator, mover and a shaker and builder.

Warmly,
Herb
VNSdepression.com

.

Anonymous said...

Dearest Herb,

In case you didn't catch it, there was a thick layer of sarcasm in my note. The sarcasm was not so much directed at any one treatment, as at a research establishment that has very odd ways of creating frenzies around therapies and of defining what placebos and medications do. When medication induced suicide attempts no longer are diagnosed as suicide attempts, there is something very rotten in the field of psychiatry; to do so is to know that patients down the line will suffer horribly and needlessly.

Were it not so horribly tragic, it would make a great farce. I was offered vagal nerve stimulation, that is a brain implant, for my "treatment-refractory depression," at one of the medical centers that is now in the headlines because its ethics code appears to on occasions have been honored in the breech. I write this having once dined with two residents at said "top-tier" medical school, both of whom were appalled by the "interpretation" of research "data" that was expected of them. One of them was so appalled that he was mulling terminating his residency at said school. This doesn't sound like a happy story, and it certainly wasn't one.

As it turns out, all this time, years of quality time as a "treatment-resistant depressive" I was actually suffering from an amalgam caused heavy metal intoxication.

In Sweden, there seems to be a decent understanding of this:
http://www.amalgam.se/pleva.html

More than a few sorry bastards on disability have been known to slowly get well when these fillings were removed.

In the United States, on the other hand, outfits like quackwatch (sic) have long insisted no such thing exists, and licensing boards have been all too happy to carry their water. This despite clear, peer-reviewed studies that date back to at least the 1920s, (Alfred Stock) that consistently identify chronic depression as being a possible result of these fillings.

http://www.bolenreport.net/feature_articles/feature_article045.htm
http://www.toxicteeth.org/

I agree with you that it is so much easier to tear down than to build up. But I think that when rampant dishonesty appears to be tolerated, commonplace, and, by some appearances, even expected of "researchers," a general attitude of skepticism is healthy.

Perhaps it was foolish of me to mock tms specifically; I have no way of knowing whether it does or doesn't work. But when 6 studies are submitted to the FDA, and only 1 shows any improvement, and 5 show none, I do think it is reasonable to conclude that either the treatment doesn't work, or that the people tasked with gathering the data to prove that it works, and present a persuasive case, are not up their jobs.

Either of these possibilities, that is of a hapless company promoting a useless cure, or of witless professionals preventing the public from getting access for a new therapy for tragic suffering, is incongruous, perhaps tragic, and certainly fit for satire.

Sometimes a line of sarcasm says so much more than pages of gushing empathy; this I felt, was such a case. Mark Twain famously wrote that patriotism is the last refuge of a scoundrel; today a few branched into hiding behind the skirts of their sickest patients. I hope that you are not arguing that the FDA should approve a treatment that is not proven to work simply because people are sick.

Pardon me if I have done you an injustice, and do look into the amalgam - depression connection.

Herb said...

Anonymous,

“Pardon me if I have done you an injustice…”

No need for a pardon as no injustice has been done. I read the contents of various postings in search of ideas and information while at the same time not necessarily agreeing with some of the views of lay-persons as well as the professionals.



“When medication induced suicide attempts no longer are diagnosed as suicide attempts, there is something very rotten in the field of psychiatry; to do so is to know that patients down the line will suffer horribly and needlessly.”


Severe depression with or without medications induces suicide. In my personal opinion any additions and/or changes to a patient’s treatment regimen is a time to be even more vigilant of the patient.

Whether or not medications additions and/or changes to treatment regimen are the causation for suicidal ideations or suicide is still an area for much discussion without definitive answers.

There are also instances of patient suicide with talk therapy only. Does this mean psychotherapy induces suicide?

I stand corrected and I am now happy to read that you’re depression challenges have been overcome not by your cell phone but what I would presume is the removal of your amalgam fillings.

How did you know your fillings were the cause of your depression? Have you ever been tested for HM toxicity? Are you now depression free?

My spouse, daughter and I had used the same dentist for many years and all of us have had fillings. Our daughter and I do not suffer from mood disorders and our current dentist sees no need to remove our fillings nor does she agree with the theories regarding heavy metal poisoning. More importantly, my spouse has been almost continuously depression free these past 6 years with little to no psychotropic medications and her fillings have not been removed.

Incidentally, one of your links I am unable to read the language and another is a broken link.

I am somewhat saddened by the fact that TMS although it was acknowledged to not have any safety issues did not demonstrate sufficient efficacy at this time. The treatment of TRD requires all available treatment options and I was hoping this therapy would have added to the available arsenal of treatment options.


"I was offered vagal nerve stimulation, that is a brain implant, for my "treatment-refractory depression," at one of the medical centers…”


VNS (Vagal Nerve Stimulation) is not a brain implant or brain surgery.


“But I think that when rampant dishonesty appears to be tolerated, commonplace, and, by some appearances, even expected of "researchers," a general attitude of skepticism is healthy.”


I prefer to remain positive and optimistic although I personally maintain a very healthy dose of skepticism. While I do read some of the negative advocacy of doc (CL Psych) which is also warranted, I am reminded too of several instances of our elitist Western Medical establishment, one of which pertains to Dr. Zhang Tingdong a rural Chinese doctor. To make a long story short he was initially scoffed at for his use of arsenic to treat a rare form of cancer. He is now revered by Western cancer specialists.

I don’t know whether or not “rampant dishonesty appears to be tolerated, commonplace, and, by some appearances, even expected of "researchers." What I do know is that those professionals with whom we’ve had relationships with through the years have been trusted, compassionate, knowledgeable and helpful to my spouse and me.

At the same time I am also appreciative of the thoughts put forth by doc (CL Psych) as it leads me to think although on some issues I would and have already disagreed with his thoughts and/or analysis.

As a support person and health care advocate I read the research papers looking for potential answers to our challenges with the understanding that definitive answers are most often lacking and as cited and illustrated in these forums, improprieties and questionable data abound.

Yet, I have to make sense of all this and make medical decisions in my spouse’s best interests which for the moment have proven me to be so far correct.

Continued good health and I thank you for sharing your thoughts and experiences.

Warmly,
Herb
VNSdepression.com

.

Mark said...

Herb what a long post!
What everone here misses, is how do placebos work?
Belief right?
Is that science or religion?

Then they have retarded placebo vs drug tests.

If you test placebo VS penicillin , the patient has no mind altering effects from either.It's a blind unbiased test.

In psychiatry they use the placebo test in hopes of being scientific, but you just can't use the placebo method when testing mind altering drugs.
I bring this up because recently I saw a TV show where psychiatrist were giving people LSD to help them deal with the stress of terminal cancer.
They used a placebo group as a control in the study vs those who took LSD, to show that LSD works.
It's ridiculous.