January 26th, 2007
FDA ADVISORS REJECT MAGNETIC DEPRESSION THERAPY

Senior Associate Editor Samuel K. Moore today reports from Washington, D.C., on a meeting of medical advisors to the Food and Drug Administration to consider the approval of a promising new therapy for patients with clinical depression who are unresponsive to conventional psychiatric treatments.

A panel of advisors to the U.S. Food and Drug Administration (FDA) today recommended against the government approving a new treatment for depression that uses powerful magnets to induce spikes of voltage inside the brain. The FDA makes the final decision, but the regulators have rarely gone against their advisors. The advisors do not actually vote for or against approval but were asked to give their consensus view on whether the device had met the FDA's main criteria: whether it was safe, effective, and that the ratio of risk to benefit for the new treatment was equivalent to treatment by a device already in use.

What Neuronetics Inc., the device's maker, needed was a slam dunk. What they delivered rolled around the rim a few times and then fell away. Under FDA rules, they had to prove that the risk-to-benefit ratio for their technology, repetitive transcranial magnetic stimulation (rTMS), was equivalent to that of a technology already in use, in this case electroconvulsive therapy. Electroshock carries a number of risks, not the least of which is memory loss, but it's also highly effective. In fact, it's the go-to treatment to snap patients out of serious depression when other treatments fail.

If Neuronetics ultimately succeeds with the FDA using this set of data, and it still can, though it seems unlikely, rTMS would join vagus nerve stimulation therapy (see our March 2006 cover feature "Psychiatry's Shocking New Tools") as one of only two medical devices approved by the regulators for a mental illness since it started ruling over such devices in the 1970s. (Electroconvulsive therapy was grandfathered into approval.)

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.

The big problem boiled down to a decision the company made in its trial design years ago. There are three main tests used by clinicians to determine how depressed a patient is and whether they are getting better—MADRS, HAMD17, and HAMD24 (MADRS is the Montgomery Asberg Depression Rating Scale and HAMD is the Hamilton Depression Score). They're all questionnaires that the physician answers about a patient, such as what the patient's mood is or how often they fixate on suicide. The doctor answers each question with a number. All three tools are widely used in clinical trials of antidepressant drugs, as well as to determine whether a patient qualified—that they were depressed enough but not too depressed—for the trial. The doctors administering the trial had to fill out all three and didn't know which was most important to the study—the primary outcome.

Neuronetics used the HAMD24 to determine who should go in the study but the MADRS as the primary outcome. More specifically, they were looking for a significant improvement in treated patients versus those who got the sham. Wouldn't you know, the MADRS result was just shy of being statistically significant and the HAMD results were significant.

Neuronetics tried parsing the data this way and that, but ultimately to no avail. In what seemed a response to an impromptu plea by Columbia University psychiatrist Sarah H. Lisanby, several panel members admitted that they thought there was "a signal" in the data—that the device was having some effect. But even those panelists said they were not comfortable with the size of the signal. Their advice to Neuronetics: Try again.

As a former patient who suffered from chronic depression for over twenty years, I am a strong advocate for new depression therapies. The utter despair and hopelessness I experienced was gruesome beyond words. Depression sufferers need all the viable weapons to fight this baffling disease. But we don't need false hope. The deliberations of FDA's Neurological Committee indicate that this very expensive therapy offers false hope, at best.

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

If I were a clinician, I would have been embarrased to present this treatment option in front of the Committee. Brain stimulation clearly will be of critical importance in bringing new, safe and effective therapies for depression. But let's not waste FDA's time and resources on "marginal at best" treatments. Because depression is so misunderstood, future brain stimulation treatments must be bullet proof before being submitted to the FDA.

Unfortunately there were no winners with TMS or the FDA's Committees deliberations. Hopefully the valuable knowledge learned about stimulating the frontal cortex by sending a focused magnetic field into the skull will serve as a solid foundation in the next generation of brain stimulation techniques.

MyDepressionSpace

How awful - and how typical. If ECT had to go through clinical trials today, it would never pass, just because of the terrible side effects.

Having had rTMS for severe, treatment-resistant depression, I can truly say it is the ONLY treatment that has provided me with a quality of life comparable to that of the every-day person. And while I do require periodic "tune-ups", it is a small price to pay to have a life.

The treatment works on the same percentage of people that ECT works for, without the problems of side effects, especially those of memory loss, confusion etc. I was willing to pay to take a chance, and it was well worth every penny.

I hope those of you who are in the same kind of pain someday at least have the option of trying rTMS. And I'm REALLY happy it's available here in Canada.

I smell a rat, or a fish.
Who are the members of the FDA panel? What's the industrial political angle here?
With assured safety and questionable efficacy, why get a NO vote.

I have had a positive experience with rTMS also. It is available on a limited basis here in the United States. The only catch is since it isn't approved by the FDA for depression insurance companies won't cover the expense. That precludes many people from getting the treatment that may otherwise benefit from it. So sad when the side effects are much less than ECT, VNS and most drug therapies.

I too have used RTMS and found it to be very effective. The key for me is to know what to expect and how to use it to benefit me. I start to show dramatic results beginning at least a month to eight weeks after the treatment. The benefits last about a month. ETC begins to show results immediately after treatment so a fair comparison can't be drawn between the two. The side effects from ETC can be horrible in some people. RTMS requires monthly follow up treatments for me. My results with RTMS are dramatic. If a placebo worked for me I would have been cured long ago with all of the various treatments that I have had over the years. Sadly, the FDA, to the best of my knowledge, did not consult anyone who actually benefited from the treatment. RTMS works so well that I will continue my trips to Canada for treatment.

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The List:

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Make Money Fast by Transforming 6 Dollars into Thousands of Dollars

Here's a legal way to supplement your income by earning thousands of dollars using the standard mail delivery service.
IT WAS PROVEN on Oprah and is COMPLETELY LEGAL!

You Can Laugh at Money Worries if You Follow This Simple Plan!
This is an opportunity for people who would like to work at home, and is an opportunity for them to invest time to get the lifestyle they have been wanting!

READ ON: Read this entire message carefully! (Print it out or download it.)
I found this on a bulletin board, and decided to try it.

Step 1: Get 6 separate one dollar bills, get 6 pieces of paper and write the following on the paper PLEASE PUT ME ON YOUR MAILING LIST. Wrap each dollar bill in each note, and include your name and address. Next mail the envelopes to the six people on the list.
Step 2: Now take the number 1 name off the list below, and move the other names up (6 becomes 5, 5 becomes 4, 2 becomes 1, etc.) Make sure to add your name as number 6 on the list.
Step 3: Now post your article to at least 200 newsgroups and message boards. The more you post the more responses you’ll get, and the more money you’ll make!
DIRECTIONS TO POST: (1)=open a blank word processor file(MS Word, Notepad, etc.), and place your cursor at the top of the blank page. From the edit menu select paste. Past a copy of this letter onto the word processor document so you can add your name to the list. (2)=save your new word processor file as text file. (3)=Log on to search engines like yahoo.com, google.com, altavista.com, excite.com, etc. then you search with the subject “money making message board”, “millionaire message board” or “money making forum” etc. (4)=Visit these message boards and post this article as a new message by highlighting the text of the letter and selecting paste from the edit menu, paste it. Fill in the subject, this will be the header that everyone will see as they scroll through the list of the posted groups. Click the post button, submit button, etc. You are done with the first one! Just copy and paste the same letter to the other groups. It will take about 30 seconds for each group. Remember the more newsgroups or message boards you post the more money you will make! You have to post a minimum of 200. That’s it! You will be soon be receiving money from all over the world, you may eventually need to rent a P.O. Box due to the large amount of mail you will be receiving. If you want to stay anonymous, you can make up a name to use, as long as the postman will deliver it. Just make sure all addresses are correct. When your money begins to come in, give it the first 10 percent to charity with spirit and share a good fortune!

The List:

1.Nichlas St. Lawrence, 689A Victory Hwy., West Greenwich RI 02817
2.Ryan Joseph, 338 N.College St., Newcomerstown OH 43832
3.Meg Nunn, 528 17th Place, Snohomish WA 98290
4.Benjamin Richards, 1587 Moonbeam LN, Chula Vista CA 91915
5.Ryan Miller, 588 Railroad St., Newcomerstown OH 43832
6.Robert McLeod, PO Box 496, Oxon Hill MD 20750