CFSAC Nomination: Jeannette Burmeister

Wouldn't it be great to have patient advocate Jeannette Burmeister on the Chronic Fatigue Syndrome Advisory Committee?  On her blog, she's been a fierce advocate and takes no prisoners when it comes to the government's mishandling of ME.  She's been nominated already by patient advocates John Herd and Eileen Holderman. Holderman fought the good fight on CFSAC; her tenure expires in the spring. 

Now patients could certainly use another strong patient advocate.  If you'd like to shower Burmeister with the support she's earned, email CFSAC@HHS.gov and tell the agency.

New ME Film: Canary in a Coal Mine

Jennifer Brea and Kiran Chitanvis have just launched their Kickstarter campaign to raise $50,000 to make Canary in a Coal Mine, their documentary about ME. Brea, a journalist, came down with ME three years ago. An interview with Brea will follow shortly on this blog. You can share their campaign with others and view two terrific clips from their film here. When you click to get to the film clips, you'll see where you can donate to Kickstarter. 

CDC's Two-Day Exercise Test: Not Negotiable

Center for Disease Control's head of CFS research Dr. Beth Unger is slated to do a problematic one-day ME exercise study called the Cardiopulmonary-Exercise Testing, instead of the two-day test favored by most patients and ME-educated researchers. What’s wrong with Unger's study? 

The problem is that studies show that defects in ME patients' exercise capacity aren't evident until the second day of testing. With one-day testing, ME patients resemble deconditioned controls, a fancy phrase for couch potatoes. 

In a letter discussing her reasons for favoring the one-day study, Unger says two days would be an “unnecessary burden” for patients. Would most patients prefer a difficult one-day study that makes ME sufferers out to be indolent grumblers or a grueling two-day study that shows just how sick ME patients are? Do I really have to answer that question? Besides, the very sick patients who can't handle the second-day exercise test provide helpful data for researchers. The fact that they can't do a second day would become part of the study's findings.

Could Unger just not know about second-day crashing in ME patients?  Dr. Chris Snell, an expert in the field of exercise testing for ME patients and a proponent of two-day testing, served as president of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Unger attends its meetings, so she's aware of his work.

In citing other reasons for her decision to go ahead with one-day testing, Unger said more patients could be tested in a one-day study. To which I say: Quality, Dr. Unger. Not quantity. 

Exercise Not Negotiable 

When the one-day study shows most ME patient to be just deconditioned—not sick—the phony prescription will be, of course, exercise. Patient advocate Mary Schweitzer, in a terrific post on Unger's proposed study, calls it a set-up; I call it rigged.  

Unger believes in graded exercise for ME patients the way Republicans believe in the late Ronald Reagan. In fact, Mary Schweitzer makes this trenchant point about Unger:  

"The only time I ever saw Dr. Unger get angry in a CFSAC meeting was when we were all calling for a change in the CDC's recommendation of graded exercise. We asked not only that they quit recommending it, but also that they openly WARN physicians about the dangers. She was furious. She said that the emphasis on graded exercise was supported by scientists and was 'not negotiable.' Those very words. 'Not negotiable.' "

Patients need a CDC researcher who understands how dangerous exercise can be. How does Beth Unger get off telling patients that she knows best, that graded exercise is good for them, when it's the patients—not she—who understand this disease, who've been suffering for years if not decades? 

Patient advocate Cort Johnson has also written an in-depth piece arguing for a two-day exercise study. He points out that instead of enlisting the experts in the field to conduct the study—Snell and Stevens—CDC is calling upon Connie Sol, who, he writes, has done only one study.

Chris Snell's Studies

The way I see it, it's clear to most patients, advocates and ME-educated researchers that a two-day exercise test is necessary. In a letter, Unger explained that she had consulted Snell on which he thought was the better approach—one-day or two-day exercise testing. Snell said two-day testing. 

When asked to comment on Unger's proposed study, Snell wrote in an email to CFS Central: "Unfortunately I do not feel able to comment on the proposed CDC study at this point. I am not involved in the study and do not know much about the design, measures, or any hypotheses they intend to test. My views on exercise testing for ME/CFS are well-documented, including a number of presentations available on the WWW. The most recent is the FDA ME/CFS drug development workshop earlier this year. Please feel free to cite any of our work or public comments."

Snell and Steven's most recent study, published in June, found that two-day testing is vital in ME patients, with emphasis added:

"The objectives for this study was to determine the discriminative validity of objective measurements obtained during CPET to distinguish individuals with CFS from non-disabled sedentary individuals. Methods Gas exchange data, workloads and related physiological parameters were compared between 51 individuals with CFS and 10 control subjects, all females, for two maximal exercise tests separated by 24 hours.  Results  Multivariate analysis showed no significant differences between controls and CFS for Test 1.  However, for Test 2 the individuals with CFS achieved significantly lower values for oxygen consumption and workload at peak exercise and at the ventilatory/anaerobic threshold. Follow-up classification analysis differentiated between groups with an overall accuracy of 95.1%. Conclusions The lack of any significant differences between groups for the first exercise test would appear to support a deconditioning hypothesis for CFS symptoms. However, results from the second test indicate the presence of a CFS related post-exertional fatigue. It might be concluded that a single exercise test is insufficient to reliably demonstrate functional impairment in individuals with CFS. A second test may be necessary to document the atypical recovery response and protracted fatigue possibly unique to CFS, which can severely limit productivity in the home and workplace."

In other words, according to Snell's study, it takes two days of testing to see the poor recovery response—post-exertional malaise—in patients. 

Tom Hennessy

On another note, Tom Hennessy, a ME patient I’ve know for 19 years who lived with debilitating pain, committed suicide on September 9th. If Beth Unger, CDC and HHS spent more time doing legitimate research, perhaps patients like Tom wouldn’t feel the need to end their lives.  

                                                                   ***

Interview with Ryan Prior and Nicole Castillo of The Blue Ribbon

Journalist Ryan Prior and filmmaker Nicole Castillo didn’t have an aha moment that prompted them to make the documentary, The Blue Ribbon, about ME. Their interest, which marinated over a period of months, began when Prior, who’s had ME since October 2006, wrote his first piece on the subject for the USA Today College blog in October 2012, “two weeks after Ian Lipkin’s nail-in-the-coffin study on XMRV,” he recalls. The response to Prior’s piece was overwhelming: The average USA Today college story generates 30 Facebook likes; this one got 500. 

“I had touched such an untapped reservoir of pain,” Prior, 23, says evenly. Some of the patients who weighed in, he says, had contemplated suicide, and Prior realized that more needed to be done about ME. Advocates started contacting Prior, and he began his immersion into the disease.

Social Justice
For her part, 23-year-old Nicole Castillo, who doesn’t have ME, has worked on feature films and in television. Currently, she serves as a TV computer graphics technician and floor director. But her passion is social justice. After volunteering at a men's homeless shelter, a daycare center, a nursing home and even spending her spring break senior year living at a convent, she knew she wanted to make medical and social-justice documentaries and was itching to start. She just needed the right subject. And she found her inspiration closer than she could have imagined, in Prior, who is also her boyfriend.

“Seeing Ryan’s hardships with ME/CFS was heartbreaking,” Castillo says. “It made me feel so helpless myself. With little understanding of the bouts of brain fog, exhaustion and inability to speak, it was devastating to not be able to help him.” At the time, Prior and Castillo were students at the University of Georgia, and Prior was having trouble keeping up because of ME. In fact, he was about to drop a class he needed to graduate to complete a dual degree. “Because he has such a supportive family, adaptations in his schedule and lifestyle and a lucky bout of timing, he prevailed,” Castillo says. Prior graduated with his dual majors—with honors.  “Unfortunately," says Castillo, "this is not the norm for so many patients.

“After experiencing a loved one go through all of that, I refuse to stand still when I have an opportunity to be a voice for the ME/CFS community,” she says. “I will do my very best to make a documentary to do justice to those in despair, and demonstrate a pain that is far too unknown to the mainstream. I want to make a documentary for the public, politicians, journalists, researchers and doctors to display the grand need for support.” 

Castillo is overseeing production, audio, camera and editing of the film. “I want to capture the spirit of what Ryan is trying to get across,” she says. 

West Coast/East Coast Filming
Prior admits that he’s had a lot to learn about ME—and his education from the patient community has been swift.  Even though he’s lived with the disease for nearly seven years, he, like many patients, used to accept the Centers for Disease Control’s (CDC) definition. At only 23, he hadn't been aware of the long, sordid history of the disease until he began writing about it.  "But I did realize a much more national discussion needed to take place," Prior says. "The goal of the film is to bring more awareness to this disease.” 

Prior and Castillo want their 90-minute film to resonate with the entire patient community—and at the same time to resonate with the public at large.  The two will spend 10 days conducting interviews on the West Coast, and then move on to the East Coast.  Among others, they hope to interview Dr. Andy Kogelnik at the Open Medicine Institute, Gunnar Gottschalk and Dr. Daniel Peterson at Simmaron Research, Staci Stevens and Dr. Chris Snell at the University of the Pacific, Dr. Judy Mikovits, Dr. Nancy Klimas, Dr. Ian Lipkin and perhaps government officials. “There are no plans to interview the Whittemores yet,” he says.

They also plan to meet with a few patients in the 25 percent—the sickest, bedbound patients.  Both Prior and Castillo are concerned, however, that the interviews and the technology they’re bringing in their homes will be problematic for the patients, and they want to minimize their distress.

Medical Fellowships
In addition to making the film, Prior and Castillo hope to raise $50,000 for 10 medical students to do eight-week fellowships with ME experts. “We hope they will help train the next Daniel Peterson or David Bell,” Prior says.

Following Dr. Jacob Teitelbaum’s ME protocol, Prior is highly functional now.  That wasn’t the case when Prior, a serious soccer player and runner, first got sick and had to drop out of high school. Now, Prior can even exercise—every other day.  When he tries to exercise daily, however, he crashes. 

Raising Money
If Prior and Castillo raise enough money, the duo may continue filming in the U.K. and/or Hawaii, where the film Unbroken, based on ME patient Laura Hillenbrand’s book of the same name, is being directed by Angelina Jolie.

Where they go is up to the public—and funding. After the Kickstarter fundraiser for the film ends July 10, Prior and Castillo will ask patients to vote on where they should go next. “Aristotle said democracy was mob rule, but we feel that the patients have bigger and better ideas than anything Nicole or I can come up with,” Prior says.

If you’d like to contribute to The Blue Ribbon, go to Kickstarter by July 10, or donate to the film’s PayPal account after the 10^th. 

Ampligen Up for Approval--in Argentina

Hemispherx, the company that makes the experimental ME drug Ampligen, applied for approval in Argentina in July of 2012.  ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), Argentina’s version of the FDA, generally renders decisions in one year. The company already received approval for a form of interferon called Alferon in Latin American countries (it's approved in the U.S. for genital warts). And ANMAT broadened Alferon's approval this year to include other diseases, including hepatitis C.

Hemispherx's stock price, which had plummeted from $1.10 to 18 cents a share following FDA's refusal to approve the drug for ME at the close of 2012, recently has been edging up, hitting a high of 29 cents today.

GONE TO THE FDA

I'm going to the FDA tomorrow and Friday.  If Internet connections and my Kindle cooperate, I'll try to post on Twitter in real or semi-real time.  If not, I'll post when I return.

Ampligen: It's a NO

From the GlobeNewswire:

Hemispherx Biopharma, Inc.(NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen® for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

In its Complete Response Letter ("CRL"), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen® for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. 

In the two pivotal clinical studies that form the basis of approval for Ampligen®, Hemispherx believes that the primary efficacy endpoints were met and that they showed a statistically significant improvement (i.e., with a p-value of 0.05 or less). The FDA and Hemispherx do agree that in clinical study AMP-502, the primary endpoint was met (p=0.02). In clinical study AMP-516, the FDA's analysis resulted in a p-value of 0.10, while Hemispherx's calculation resulted in a p-value of <0 .="" nbsp="" p="">

Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA'sCenter for Drug Evaluation and Research regarding the Agency's decision. The purpose of the conference is to review all of the issues raised in the Agency's CRL as well as to discuss the corroborating data and experiences of clinicians and patients who have seen the benefits of Ampligen® therapy. 

Hemispherx has become aware that a prominent CFS advocate and long-time CFS sufferer, who has been on Ampligen® since 1999 through a treatment IND, began a hunger strike on January 30, 2013 to seek FDA approval of Ampligen®.  Hemispherx understands the frustration that there is still no FDA-approved treatment for CFS and the concern that patients may lose access to Ampligen® therapy. Out of concern for the health of the CFS community, Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, CFS clinicians and patient advocates to find a solution to this significant unmet medical need. 

In the past, the FDA has shown great willingness to work with stakeholders to find solutions for serious and life-threatening illnesses. Dr. Margaret Hamburg, Commissioner of the FDA has previously stated that, "FDA has an important role to play in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges." Hemispherx hopes that the FDA will view the Ampligen® end-of-review conference as an opportunity to involve patient advocacy, clinicians and researchers in a concentrated effort to do something for these patients over the near-term, including further evaluation of how new legislation, such as the recently enacted "FDASIA" statute, may have a role in finding a solution. The views of one internationally recognized researcher/clinician, Dr. Nancy Klimas, who has over 20 years' experience evaluating and treating CFS patients, can be found athttp://www.sciencedaily.com/releases/2013/01/130124183448.htm

DISCLOSURE NOTICE: The information in this press release and the article referenced therein includes certain "forward-looking" statements (explained below), including statements about the remaining steps, including the aforementioned end-of-review conference and appeals process, which the FDA may require and Hemispherx may take in further seeking FDA approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA.  Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen® NDA. 

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visitwww.hemispherx.net.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "believes," "plans," "anticipates," and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations and represent the Company's judgment as of the date of this release. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved, including its intent to pursue the end-of-review conference and appeals process. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K and Hemispherx's beliefs that the Ampligen® NDA may be covered by the new provisions of the FDASIA statute, which are subject to FDA interpretation and implementation, or that such provisions, if applicable, will be helpful with regard to obtaining FDA approval of the Ampligen® NDA. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.

Hamlet Without Hamlet

Patient advocate Bob Miller, who's on the experimental drug Ampligen, has been urging FDA to approve the medication for ME by going on a hunger strike.  He's been fasting since January 29th: six days.  Healthy people fasting for six days would be weak. But someone with ME?

Last month another patient advocate suggested to me that ME patients or their loved ones go on such a strike.  I shook my head and gave a gallows-humor kind of laugh.  I thought it cruel to ask such sick patients to stop eating, more unthinkable than doing Hamlet without Hamlet.  And as for loved ones who'd lend that kind of support, well, I don't know about you, but I don't know too many people who believe in ME, let alone be willing to fast for someone with the disease.

But maybe it doesn't always take a lot of people to effect real change.

Ironically, perhaps his being on Ampligen has given Bob Miller enough strength for a hunger strike.  Or maybe Bob Miller's just so fed up with the pathetic state of affairs with ME that he brought out the big guns.  With no drugs except tottering Ampligen and little useful research, it's drier than the Sahara out there.  Miller's one-man hunger strike is, thankfully, garnering a lot of attention, including that of a well-known early AIDS activist, Cleve Jones.

Jones's character appeared in Gus Van Sant's fantastic movie Milk, about the slain politician and gay activist Harvey Milk. In this clip, Milk (played by Sean Penn), enlists Jones (Emile Hirsch) to join the revolution for gay rights. For a grim laugh, try substituting "CDC" for "Franco" and "ME people" for "gay people."


Here's the press release about Bob Miller's hunger strike:

FOR IMMEDIATE RELEASE

Contact: Bob Miller and Courtney Miller
Tel: 703-554-5575 
Email: bobmiller42@msn.com

PATIENT ON HUNGER STRIKE GAINING ATTENTION 

Well-known Journalist and Long-time AIDS Activist Offer Support 

Calling attention to the plight of one million disabled Americans suffering with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), patient Robert Miller continues his hunger strike -- and it is gaining attention from a well-known journalist and a long-time HIV/AIDS activist, as well as an NBC affiliate in Nevada.

These new developments come as we wait for the Food and Drug Administration's decision, due Monday, Feb 4, 2013, on whether or not it will approve Ampligen, the first medication ever considered by the FDA for ME/CFS. This illness disables one million Americans, leaving many bedridden, homebound and suffering for decades on end with little hope for recovery and little help from the U.S. government, which dedicates a mere $6 million dollars each year to ME/CFS research.

First, well-known HIV/AIDS activist, Cleve Jones, founder of the AIDS quilt project, came out in support of ME/CFS patient Robert Miller's hunger strike. Mr. Jones writes: “My friend is on a hunger strike to get the first medicine approved for his severe case of chronic fatigue syndrome. FDA is likely to deny the drug this weekend. We know we wouldn’t be where we are today if some of us hadn’t protested inaction by federal agencies on AIDS treatments. Email: kathleen.sebelius@hhs.gov  Urge FDA to approve Ampligen, so all CFS patients can have just one treatment option. CFS patients suffer without any treatments, and I can remember those days in my life. I urge Secretary Sebelius to approve Ampligen for CFS and apply what we learned with HIV about getting treatments to patients like every minute counts.”

Secondly, long-time Washington DC journalist, Llewellyn King, commented on ME/CFS sufferer Robert Miller's hunger strike on his PBS television program, "White House Chronicle." It is airing this weekend on PBS stations in Washington --Sunday, Feb. 3 at 9 a.m. on WETA, Channel 26; Sunday at 11:30 a.m. and 6:30 p.m. on WHUT, Channel 32. It will air throughout the week on some 200 PBS and public, educational and governmental cable TV stations and worldwide on Voice of America Television. An audio version of the episode will air Saturday, Feb. 2 at 9:30 a.m., 3:30 p.m. and 9:30 p.m. on Sirius XM Radio's POTUS (Politics of the United States) Channel 124. The episode will be posted on the "White House Chronicle" Web site, whchronicle.com, on Monday, Feb. 4.

Lastly, NBC's Reno, Nevada affiliate has covered the hunger strike: http://www.mynews4.com/news/local/story/Patients-fight-for-FDA-to-approve-drug-application/zuCxhkI0eUOiECmK_McvmA.cspx

Activist Rivka Solomon, a Boston-area playwright who has spent 23 years disabled by ME/CFS, much of it homebound and bedridden, states, "One million disabled Americans feel abandoned by their government for over two decades. They feel this can not continue and that they have no choice but to take extraordinary measures, such as a hunger strike, to get the help they need from the U.S. government. I support Robert Miller and other patients who are doing all they can to get us the medications we need to help us survive. We hope the FDA cares enough about its disabled citizens to approve Ampligen."

# # #

If you'd like more information about this topic, or to schedule an interview with Robert Miller, please call 703-554-5575 or email bobmiller42@msn.com

BOB MILLER'S HUNGER STRIKE

Advocate Bob Miller has been on a hunger strike to try to convince FDA to approve the experimental drug Ampligen for ME.  He and fellow patient Dr. Janet Smith got a terrific piece of local news coverage in Reno, Nevada. FDA is scheduled to make a decision on Ampligen's fate by tomorrow.  Given that the FDA committee voted no to Ampligen on December 20, odds are slim that the FDA will overturn its committee's decision, but it ain't over until it's over.

Bob Miller posted this on Facebook today:
"Patients who are able can call NBC News at 212-664-4444 and comment on the story [above]. Be sure to tell the person who answers why you are calling, they will put you through to a comment line where you can request for them to please cover this important news story nationally, be sure to tell them where you are calling from."

FDA'S DOUBLE STANDARD

A mad-as-hell Sid Wolfe of the watchdog group Public Citizen sued FDA about the agency's refusal to ban the highest dose of the Pfizer Alzheimer's drug Aricept--and lost. Studies don't show increased efficacy of the 23-milligram pill compared with the lower doses of 5 and 10 milligrams.  However, the higher dose does show increased toxicity, including, Wolfe said, increased mortality.

According to a comprehensive article by reporter Ed Silverman, the director of the FDA’s Division of Neurology Products, Rusty Katz, explained his reasoning for keeping the higher dose by posing a question and then answering it:  “Does the absence of a demonstration of any superiority of the 23 milligram dose to the 10 milligram dose on measures of overall functioning, coupled with the increased incidence of potentially significant adverse events, argue against the approval of this product?” The 23 milligram dose is “clearly superior to the 10 milligram dose” on a cognitive measure.* “In my view, this strongly argues for a conclusion that the 23 milligram dose is very likely to also have an effect on overall functioning, despite this not having been demonstrated directly in this study” [emphasis added].

Reporter Ed Silverman also wrote that given the few Alzheimer's treatments available, FDA believes that physicians may decide the added side effects justify the benefits. 

Following that logic, FDA, Ampligen's side effects are in most cases, minor or manageable, and given that there are no FDA-approved ME treatments, shouldn't Ampligen be approved?  Instead the FDA committee, while endorsing Ampligen's safety, voted that the drug didn't meet FDA's standards for efficacy--though it was "probably effective."  Probably effective sounds an awful lot like the "very likely" of two paragraphs up.

Why the double standard, FDA?  Could it be FDA is throwing the pharmaceutical giant a big bone because the patents on the lower doses are expiring?  Could it be that FDA believes Alzheimer's to be more important than ME?  Could it be, as Sid Wolfe suspects, that FDA doesn't want to admit it was wrong in approving the 23 milligram dose in the first place?

Sid Wolfe also testified at the FDA Ampligen hearing on December 20 that Ampligen shouldn't be approved either.  (And a patient I talked to at the meeting said she overheard him say that cognitive therapy works.) 

Here's Ed Silverman's story, if you want more info.

*In three of the four tests, there was no increase in cognitive function at the higher dose.