Selling Sickness 2013 http://sellingsickness.com PEOPLE BEFORE PROFITS Mon, 20 Jun 2016 17:42:48 +0000 en-US hourly 1 ANTIDEPRESSANTS AND SCREENINGS. HAVE WE REALLY MADE ANY PROGRESS? http://sellingsickness.com/antidepressants-and-screenings-have-we-really-made-progress/ Mon, 01 Feb 2016 21:03:05 +0000 http://sellingsickness.com/?p=1586 I can’t believe its my 75th trip out to Washington DC since Woody died in August 2003. As I was preparing for this trip, I was reflecting on what little progress has been made in FDA/pharmaceutical drug safety over the years.  It always seems like its a game of whack-a-mole when FDA, Congress, and the powerful PhRMA and healthcare lobbying money and politics mix.

Sure, we helped get black box suicide warnings added to antidepressants back in 2004 and 2006.  This was 13 years AFTER the FDA first held hearings on Prozac and suicide in 1991 and did nothing about it. Despite these warnings today, it seems everywhere you turn the need for more mental health and its pill solution is in the news or advertised on television.  It makes me wonder if we have really made any progress.

Last week a group of researchers from Cochrane Collaboration released the largest meta-analysis of antidepressants studies showing that antidepressants DOUBLED the risk of suicide and aggression in kids under 18.  This analysis which appeared in the British Medical Journal is huge news as its counter to what the initially-reported findings given to the FDA. The researchers also say the suicide risk was under reported from the beginning and the original poor study designs did NOT detect the risks. They assume the same in adults although the studies didn’t show it. There was little reported in the US about the biggest ever review of antidepressant trial data like it was in the UK.

Meanwhile in our country last week, the United States Preventative Task Force (USPTF) comes out with the recommendation that EVERY US adult be screened for depression.  This is really disturbing especially when you look at the screening tools that are being currently being used by clinicians. They are riddled with conflicts of interest and ties to the pharmaceutical companies. The PHQ9 form is considered industry-accepted standard. It has been adopted in many health systems across the country, including my own Alina Health Systems. It is handed out when you check in at the doctor’s office.

Apparently no one reads the tiny disclaimer type at the bottom where is says created by Pfizer, Inc. Doctors and patients alike have no idea and just go along with the status quo. The screening tool asks leading questions that can quickly end in a diagnosis and an antidepressant prescription.  It asks questions like…In the past two weeks have you experienced … feeling down, tired, or having little energy, eat too much or too little, feel bad about yourself…. Who doesn’t? Its called being a human. Personally, I refuse to fill the form out at the doctor’s office even though the receptionists pressure me.

With these two contradictory reports last week alone, no wonder why the public is confused about mental health and the psych drugs. The public needs to push back and start critically looking at what’s happening in the world of mental health. Maybe what we have been told just isn’t the answer?

There have been many times I have wanted to quit this fight. Sometimes it seems so useless, that is, unless you like the feeling of beating your head against a brick wall.  But then I get an email like I did last week from a young guy who’s 48 year old father was put an antidepressant because he was getting divorced. 5 days later he hung himself. The family is devastated and had no idea about the link between antidepressants and suicide. They just did, like most people do, trust their doctor.

It made me realize that Woody’s story is as relevant today as it was 13 years ago. So, I will go and proudly represent the young kid’s dad, Woody, and countless of other families who live everyday with the consequences of a failed drug safety system.We were all just regular people living our everyday lives, trusting the system, until the unspeakable happened.

The reality is that it could be any one of us.

 

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A TRAGIC REMINDER HOW FRAGILE LIFE IS http://sellingsickness.com/a-tragic-reminder-how-fragile-life-is/ Tue, 19 Jan 2016 17:45:28 +0000 http://sellingsickness.com/?p=1573 2016 started out with the tragic reminder of how fragile life is.  Last week one of my good friends – Karen Langhart took her life.  She was just 56 years old.

I will never forget when I first met Karen in 2012 about 6 months after the death of her 24-year old daughter, Erika, from a pulmonary embolism caused by her birthcontrol Nuvaring. We were at a conference in Washington DC and Karen got up in front of the 250+ audience to ask a question of the speaker.  She was articulate, smart, poised, and knowledgeable about the subject, and not to mention, quite stunning and tall.  I thought she was one of the researchers attending the conference. It wasn’t until she said that she was the mother of Erika who died on the prior Thanksgiving day of Nuvaring.   I immediately introduced myself and we became fast friends.

Karen was a mom on a mission to make sure that what happened to her daughter didn’t happen to another family. She worked tirelessly around the clock researching links, causes, and finally setting up a foundation in her daughter’s name – Informed Choice for Amerika.

The Langhart’s story was featured in Vanity Fair and on CNN’s Anderson Cooper.   They pursued legal measures against Nuvaring manufacturer Merck.  However, in the end they did NOT take the pitiful Merck NuvaRing settlement which would have silenced them for little $.  Last month Karen brought together activists, parents, researchers, film makers to Las Vegas for the first Woman Up conference.

Karen was truly a force that couldn’t be reckoned with. A brave soul.  She accomplished so much through sheer grit, passion and talent while enduring such deep personal loss.

She will be greatly missed by many.

For me personally, I am still processing her death and how it relates to the bigger picture of advocacy. Karen’s loss is truly significant not only to her husband and son, but to all of us.

Karen did what so many harmed families do. They want to stand up and make difference in a very cumbersome and difficult regulatory, legal and medical system.

Advocating for change after a personal loss takes a lot of energy.  You spend countless hours doing everything you can to make sure that no other family has to experience what we went through. Initially, it can be cathartic and help make sense of a tragic and unnecessary death. However, as one discovers the truth about the lies, deception and dangers, it becomes a bigger mission of wanting to make sure others have the information their family didn’t. Knowledge is power.

Advocating for change often feels like a very lonely road going nowhere. From the outside people see you as strong, driven, and effective in delivering your message. However, they often don’t see the inside tears being shed or when you go home to an empty house. Karen’s death is a reminder and makes me give pause to all my fellow advocates who have personally suffered yet are doing something about it. Self care is really important and recognizing when a break is needed. Your voice is the greatest asset for the issue.

Finally, these kind of tragedies don’t just impact the individual person, they affect families, friends and communities forever. Its has a ripple affect. The fall out from medical harm, regardless of cause, can add additional layer of suffering to the event itself. Loss, grief, anger, depression, and the damages to relationships are some of the many issues people experience. These stories of devastation left in the wake of medical harm must also be told and not forgotten.

There are real life consequences to this grueling and often unnoticed advocacy work. We need tireless advocates like Karen who are willing to stand up to corporations, the FDA, the medical establishment to make sure the truth be told. For its the unsuspecting and trusting families, like Karen, Erika, and Woody who pay the ultimate price. Just regular people living their lives until the unthinkable happens.

Karen’s legacy and the work she started will continue to inspire me and others for years to come.  Many lives will be saved because of her.

In the words of Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”

RIP my friend.  I will miss you more than you will ever know.

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MY NEW YEAR WISH … RETHINKING MENTAL HEALTH http://sellingsickness.com/my-new-year-wish-rethinking-mental-health/ Wed, 31 Dec 2014 21:03:23 +0000 http://sellingsickness.com/?p=1561 I (K.W.) have been thinking a lot lately about mental health. It seems every where you turn, there’s something about “mental health” in the headlines. Whether its another shooting, the high profile suicide of Robin Williams, or the kid who has difficulty focusing in school, the conversation quickly turns to the need for MORE mental health services, MORE screenings, MORE treatments to address these issues. What if LESS is actually more?

The public has been convinced through drug company marketing, psychiatry, and the medical establishments that “mental illness” is a biologically-based condition. Every day life’s distresses and problems are being sold as undiagnosed mental disorders caused by a “chemical imbalance” requiring a pill solution.  Often times, it is without full disclosure of the dangerous side effects.  There are a lot of powerful self-interests at play in this current model of medicalizing life stresses. Big Pharma, American Psychiatric Association (APA), and various patient advocacy groups such as NAMI all have something to gain. Drug companies are highly motivated to spend billions of dollars selling “illnesses” to push their pill treatments. The APA and academic psychiatry want to protect their roles as the “trusted” medical institution that really understand psychiatric care. Meanwhile, 70-80% of psychiatric medicines are now prescribed by primary care doctors, often after a 7-minute visit with a patient. The public certainly has a role in this current paradigm too. We have been conditioned for a quick fix pill solution after seeing drug commercials encouraging us to “ask our doctors”.

In today’s world, “mentally ill” is such a vague, general term that it lacks any real meaning. The APA’s Diagnostic Statistical Manual has set up such broad definitions of “psychiatric disorders” that 1 in 4 Americans are said to suffer some sort of “mental illness” each year. Undesired behaviors such as grief and sadness, oppositional defiant disorder and ADHD in children, to substance abuse, and so on get classified as “mental illness” requiring psycho-pharmaceutical  “treatment”.

There’s got to be a better way.

For starters, I would like to see the conversation change from mental health to focusing on mental well-being. Mental health implies a “sickness” model. The current narrative of the medical model is that untreated “mental illness” threatens the safety, security, and health of America. Therefore, we need MORE treatments.

With more of behavioral health falling into the hands of primary care facilities, the opportunity is NOW to rethink and challenge the current mental health treatments. We need a new “public trust” entity that will give us a better way of thinking about psychiatric disorders. The current system being driven by pharmaceutical companies, APA, and highly effective advocacy front groups doesn’t work. A new multidisciplinary group comprised of professionals and consumer advocates needs to take on this task to envision what a new system could look like.

Last month, I attended The International Society for Ethical Psychology & Psychiatry (ISEPP) conference in LA and there was a lot of discussion and presentations around redesigning a better system that really helps society thrive. There were a couple presentations that  made an impression on me. First, the debate between Allen Frances and Bob Whitaker about the role of psychiatry and the APA in helping shape society’s thinking around mental illness was fascinating and uncomfortable at times. Then, there was Laura Dulano’s personal story about being trapped in the “mental health system” since she was 13 years old. She offered some really great thought provoking ideas and solutions that ultimately helped her escape the system and now lives drug-free. Shannon Hughes’ presentation on how consumers sharing their real world drug experiences online has disrupted the one way flow of information and challenged commonly accepted versions of “what we know” about psychotropic drugs was enlightening. Her presentation further cemented my belief that real world experiences of consumers/patients has to be part of this new conversation around mental well-being.

In March 2015, I will be part of a panel at the Lown Institute’s Road to Right Care conference discussing the over-treatment and over-use of psychiatric drugs. It will be another opportunity to engage the audience in discussions around improving mental well-being while avoiding over-medicalizing life distresses.

I feel passionately that something needs to change.  We got to do better for future generations.  Are we giving people the tools and skills to deal with life’s challenges vs popping pills?  Where’s the community-based care with human connection? What about more peer support groups like Face It Foundation?  Would having better housing and jobs available help people live more meaningful lives? Are we really listening and engaging with people/patients?  What role does faith an d spirituality play in our mental well-being?   How about more empathy and love?  The answers to these questions make me believe that there is, indeed, a better way.

Ultimately, we need to empower the public to challenge the current powerful mental health system to ask “what if less is really more?”

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CHRISTMAS CARDS TO WRONGFULLY INCARCERATED SEX OFFENDERS http://sellingsickness.com/christmas-cards-to-wrongfully-incarcerated-sex-offenders/ Mon, 22 Dec 2014 16:12:52 +0000 http://sellingsickness.com/?p=1554 One of the tasks I (LT) perform annually as a progressive activist is to write lengthy holiday cards of solidarity and encouragement to wrongfully incarcerated sex offenders identified by a small almost all-volunteer organization, the National Center for Reason and Justice.

This group began in the 1990s (incorporated in 2002) following the spate of accusations about “Satanic Ritual abuse” and other aspects of an “epidemic” of child sexual abuse that resulted in the wrongful conviction and incarceration of many parents, day care providers, preschool teachers, school bus drivers, and others charged with the care of children who have presumably violated their sacred trust.

I  joined as an “advisor” some years ago. There was no sexologist in the group who could provide a link to the clinical and academic sex research community and that seemed like a useful role I could play. The other advisors and directors, several of whom have written important books on the subject, are a cross section of academics, lawyers and journalists who see this as a worthy and important issue.

The discipline of writing these cards (23 this year) is very painful for me. Each year after I started in 2008, I would receive replies from about a third of the prisoners, so by this time I have quite a stack of handwritten and typed letters and cards detailing the suffering and courage of these men and women who are facing years and decades and maybe a lifetime of unjust imprisonment. Year after year they pursue legal remedies, self-maintenance and try to stay focussed and sane. It tears at your heart and I weep a lot.

This past year, one of those day care workers, Bernard “Bee” Baran, unjustly convicted and incarcerated in 1984 and finally released in 2006, died at the age of 49 http://www.berkshireeagle.com/news/ci_26460338/bernard-baran-cleared-child-molestation-charges-dead-at. He is a martyr to the craziness and cruelty of the criminal justice system.

What does this have to do with “Selling Sickness”? Good intentions undermined by lack of oversight? Social institutions perverted by misguided politics? Lives destroyed in the absence of evidence? Overzealous “experts”? Maybe the only connections are in my mind. Meanwhile, I still have a half dozen of these cards of consolation and encouragement to write.

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THE END OF THE CANADIAN WOMEN’S HEALTH NETWORK? http://sellingsickness.com/the-end-of-the-canadian-womens-health-network/ Thu, 27 Nov 2014 04:06:56 +0000 http://sellingsickness.com/?p=1551 This is sad sad news. The Canadian Women’s Health Network (CWHN), one of the pillars of the women’s health movement in North America, has announced that it is suspending activities due to a lack of funds effective November 14, 2014.

CWHN was founded in 1993 as a national (Canadian) organization to improve the health and lives of women and girls by collecting, producing, and distributing accurate and unbiased information. In its 20+ years, it has participated in important policy debates on major issues of women’s health, provided untold amounts of support and information to individuals and groups, and contributed a reliably independent feminist voice during an era when it has been more and more difficulty to sustain independence from deep pocketed corporate systems.

As a sexuality researcher and activist, I (L.T.) have used the resources of CWHN, especially the network magazine and the opportunity to consult with Madeline Boscoe, Kathleen O’Grady, Susan White, Jane Shulman, Diane Sabil, Harriet Rosenberg, Abby Lippman and the current, and I guess final executive director, Anne Rochon Ford. (I’m sure there are many others whose names have slipped my mind and I apologize.) These dedicated and brilliant women offered the kind of socially contextualized analysis and information that always made me wish I had known them longer and that we lived closer.

CWHN was a supporter of the 2005 conference I organized in Montreal on the medicalization of sexuality and again a friend and supporter of the 2013 Selling Sickness conference in Washington that Kim Witczak and I co-organized. We wanted to have a major Canadian presence to represent the activist energy and lively discussion about disease mongering there is in Canada.

Additionally, I wanted to have a panel on the Women’s Health Movement to make more young activists aware of the history and vital role feminists have contributed to all the current consumer-based, empowered patient, and overtreatment movements.

The U.S. women’s health movement groups such as the National Women’s Health Network, Our Bodies Our Selves, and the Feminist Women’s Health Centers may be better known and appear more frequently in histories of the women’s health movement, but we are all one interconnected sisterhood working for a humanistic healthcare system available to all.

Let us celebrate the contributions of CWHN and never forget them as we move forward.

 

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OPPORTUNITY FOR PATIENT INPUT – REALLY! http://sellingsickness.com/opportunity-for-patient-input-really/ Tue, 11 Nov 2014 14:54:41 +0000 http://sellingsickness.com/?p=1545 The FDA wants to know how the process for soliciting patients for the “patient focused drug development” meetings is going.

That phrase “Patient focused drug development” may ring a bell with you, but if not, here’s the cliff notes:

As the result of a long process initiated by new directives in the 2012 PDUFA, the FDA announced in 2013 that there would be 20 public hearings between 2013 and 2015 on disease areas that are serious and not well understood or well served by treatments. The 20 specific diseases were winnowed down from an initial list of 39 and public input had been solicited – 4500 comments on 90 different diseases were submitted!!

Each of the 20 meetings was designed to hear from patients: What are your symptoms? Which ones are the worst? What have you tried to alleviate them? How did the interventions work? If you could reduce or eliminate one symptom, which one would it be?

Some of the meetings added a second day as a scientific workshop where medical and research experts discussed the progress of clinical trials in the field, the status of the basic science, and how the patients’ comments had illuminated the situation. There are transcripts and webcasts of each meeting, for example here is the page for sickle-cell disease with links for the full materials.

The FDA has prepared a summary report of the patients’ contributions on each disease meeting and put them together on a “Voice of the Patient” website. They are really reporting the results of these meetings in a huge way though I (L.T.) wonder how many people are following the story.

Now, the FDA is asking how the public feels about the meetings, the plans for the next round of disease meetings, etc. Of course public means ALL the stakeholders including pharmaceutical industry, advocates, researchers, clinicians AND patients. That’s how they got the 4500 comments the first time, and will probably get lots of non-patient comments this time, too.

Based on our experience at the “female sexual dysfunction” meeting on October 27-28, 2014, some of us are emphasizing these main points:

1) Patient participation is a good idea, BUT it can easily be hijacked

2) For example, at the female sexual dysfunction meeting the patients who were chosen for panels (patients of one urologist, largely) were solicited by professional groups with deep ties to pharmaceutical companies and their expenses were paid (I called this “unethical and despicable” at the public comments section of the meeting). This resulted in a homogenous message that was focused on a few talking point. No patients of psychologists or psychiatrists were involved to give a different message about treatment

3) There needs to be wider outreach – but how is that to be achieved?? There needs to be vetting so that the panels are not composed of uniform voices. The FDA needs to hear from lots of DIFFERENT patients or the whole point is moot. At the very least, advance disclosure rules should select as diverse groups as possible

If you want to submit your comment electronically, go to http://www.regulations.gov/#!submitComment;D=FDA-2014-N-1698-0001 and put in your points.

Or snail mail to

Docket No. FDA–2014–N–1698

Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dec 5 is the deadline – let your voice be heard: We want MORE patients, more REAL patients, more DIVERSE patients, more interesting ways to solicit and involve patients!!

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REFLECTIONS ON FDA CHANTIX HEARING http://sellingsickness.com/reflections-on-fda-chantix-hearing/ Fri, 31 Oct 2014 16:23:12 +0000 http://sellingsickness.com/?p=1534 In mid October, the FDA convened a special meeting of drug safety and psycho-pharmacology experts to look at whether or not the smoking cessation drug Chantix needed to continue to carry a black box warning.  There have been numerous warnings on the drug starting in 2008, a year after it had come to market. The current warning includes a link to serious neuropsychiatric symptoms including depression, violence/aggression, psychosis, and suicidal thoughts.   There have also been reports related to insomnia, dizziness, loss of consciousness, seizures and other serious side effects.

Pfizer, the drug maker, apparently had new data showing that the reported serious adverse events were not caused by the drug but due to individual’s mental conditions and angst of quitting smoking.   Therefore, they believed the black box warning was unnecessary and asked the FDA to remove it from the drug label.  Pfizer’s own Christopher Wohlberg, MD stated, “it was time to unring the alarm bell” on Chantix.

Pfizer (with two rows of paid experts to explain) presented that their clinical trials evidence and 4 observational studies proved no such serious adverse effects existed. They got 2.5 hours to make their case.  It was followed by various presentations by the FDA about their concerns regarding Pfizer’s latest studies.   It was fun observing the expressions and body language of Pfizer’s experts during FDA presentation.

Next up was the open public comments portion of the hearing where a few of us presented including Institute of Safe Medication Practices, People’s Pharmacy, and National Center for Health Research.   I (KW) was proud to represent the voices of families who live every day with the real world consequences of a failed drug safety system.   In addition to these comments, a Citizen Petition was sent to the FDA asking them to keep the black box warning and even consider strengthening it.  It had 5 strong supporting organizations to endorse it, including Institute of Safe Medication Practices, Consumer Reports, National Physicians Alliance, National Center for Health Research, and Public Citizen. Its very enlightening and believe it was helpful for this hearing.

Ultimately, the panel voted 17-1 to keep the current black box warning.

Over the years, I have presented at numerous FDA hearings starting with the antidepressants hearings in 2004/2006 after the death of my husband.   I wanted to share a couple of my observations contrasting the Chantix hearing to the antidepressants hearings.

1) The FDA actually presented a qualitative review of the type of adverse events from their Medwatch system. They challenged how comments like “feeling like a zombie”, “couldn’t get out of bed”, and “wasn’t myself” which aren’t a diagnosis would be coded. Compare this to antidepressant hearings where we were told our stories/experiences were “anecdotal” because it didn’t happen in a double blinded controlled placebo study.  It was nice to see the FDA not ignoring the real world narrative. There were way too many reports, despite Pfizer’s attempt to blame the victim and their underline mental health and issues of cessation withdrawal.

2) There were no Chantix victims to describe first hand what it was like for them or their loved one. That’s because the 2700 victims were silenced in their legal settlement agreements with Pfizer. Pfizer learned from the antidepressant hearings where it was victim after victim telling their powerful story in the open public forum. Its hard to ignore these real life experiences. So Pfizer shut them up.

Here’s a video that I put together to represent actual Chantix victims experiences. I opened my presentation with the video.

3) In addition, there were no attorneys testifying during open public forum. During the antidepressant hearings there were several attorneys that spoke on behalf of their clients and about unsealed documents. All Chantix documents and discovery including expert depositions are forever sealed and public health knowledge is lost. Its a shame and we need the FDA to get their hands on these legal records. In the antidepressant litigation, attorneys were able to get confidential documents unsealed where many of the psychiatric (including suicide) risks associated with these drugs were well known and documented before they were released to the public. Power in documents!

What was the same, however, between the two hearings is how those with contrasting scientific/clinical evidence like Thomas Moore (Chantix) and David Healy (antidepressants) were not allowed to formally present their findings. Rather they have to try and do within the allotted public hearing time. 6 minutes and 3 minutes surely isn’t enough time when compared to Pfizer’s 2 1/2 hour presentation.

Even though we had a victory with the 17-1 vote, we will still need to keep an eye on the large post market safety study that will be completed in fall of 2015.  Until then, the black box warning remains on Chantix.

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ACT III: NOW THEY’RE PAYING PATIENTS TO GO TO THE FDA http://sellingsickness.com/act-iii-now-theyre-paying-patients-to-go-to-the-fda/ Tue, 14 Oct 2014 01:03:54 +0000 http://sellingsickness.com/?p=1529 Here’s the third installment of the saga about PR tactics on the “female sexual dysfunction” front as we get closer to the October 27/28 meeting on FSD and Patient-focused drug development.

I (L.T.) first wrote here in April 2014  about the efforts Sprout Pharmaceuticals and the professional organization ISSWSH were undertaking to promote approval of flibanserin, a serotonergic/adrenergic drug twice FDA rejected (2010, 2013) for the treatment of low sexual desire in women. Their first step was to claim the FDA was sexist in approving drugs for men’s sexual problems but not women’s. The “gender equity” ploy was at first supported by most media but fortunately received some critical press as well. However, a letter from four congresswomen  and several feminist groups created the appearance of grassroots activism. Needless to say, other feminist groups also wrote opposing letters. Duelling feminisms, one wag said.

Then, over the summer, a second tactic emerged:  a glossy PR campaign called “even the score” recruited the public to sign a petition and “get informed” about the injustices at the FDA on the topic of women’s sexuality drugs. This time, the press was less charitable and there was grumbling heard about pressure on the FDA.

So now we are in the autumn, preparing for the special two-day “female sexual dysfunction” event at the FDA as part of the “Patient-focused Drug Development” initiative called for by PDUFA 2012.  And what interesting new tactic do we see emerging at the 11th hour?

ISSWSH and Sprout have been distributing a fancy flyer online and at their various fancy lunch meetings inviting all and sundry to attend the October meeting in Maryland , but that’s no surprise. A new campaign website emerged with a new petition (claiming 15,000 signers) with the familiar messages, except for one brand new claim, “A biological lack of desire to have sex negatively impacts 1-in-10 American women.” That IS a surprise. No footnote, reference, or citation is provided, and in fact it is totally absurd because there is no biological marker, assay or sign for sexual desire that anyone has identified. So, science has been thrown to the winds, it seems.

But that’s not all! What you won’t find on line is the letter ISSWSH sent to its members in early October encouraging them to recruit their patients to attend the October FDA meeting and offering to pay patients’ travel and expenses (see below) WHOA! Now how low can you go? This is professionally highly inappropriate – even unethical. One simply doesn’t put patients under that kind of pressure.

I hesitate to say this is the final step in the saga, so we’ll just wait and see. A full page ad in the NYTimes? When there’s billions to be made, why not?

 Dear ISSWSH member, As per our prior e-blast, the FDA is holding a public meeting on FSD October 27-28, 2014 (information available on the FDA website at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm). It is important that the FDA understands how having a sexual dysfunction impacts a woman, so we are encouraging not only your attendance (online or in person), but also urging you to share this information with your patients.Your patients have several ways to have a voice and make a difference. We need to encourage them to have this voice:

1) If your patients are passionate about this issue and are able to attend the FDA patent panel, funding is now available (money is from multiple sources) to help support travel and hotel costs for patients to attend the meeting. Patients can request a travel grant by writing to sue@veritasmeetingsolutions.com.

* Please note that If they cannot attend in person, the FDA has explained that those participating on line can still vote and write comments to be included in the final FDA report.

2) For women (and men) who believe that women deserve better care, better treatment, better options etc, please ask them to go to http://womendeserve.org. From this page they can sign the letter to the FDA currently on change.org (more than 15,000 respondents to date). From this page women (and men) can also click through to the #women deserve Facebook page to share a selfie holding a sign “#women deserve” and any specific message they want to write down.

As members of ISSWSH, it is imperative that we send the message to the FDA that sexual dysfunctions are real, that they affect our patients, and that this is something that deserves their attention. We can make a difference and our patients can make a difference!

Thank you,

Sharon Parish

President, ISSWSH

Sue Goldstein

Global Program Chair, ISSWSH

 

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NOW THAT THE ICE HAS MELTED, WHAT’S NEXT FOR ALS? http://sellingsickness.com/now-that-the-ice-has-melted-whats-next-for-als/ Tue, 30 Sep 2014 14:40:50 +0000 http://sellingsickness.com/?p=1516 This summer we saw the ultimate game of truth and dare play out over social media with the ALS Ice Bucket Challenge. All over the world ordinary people as well as celebrities, billionaires, professional athletes, police departments, teachers, mayors, spiritual leaders and even ex-presidents dumped buckets of ice water over their heads to raise money for ALS. According to the ALS Association, this viral campaign raised more than $100 million in donations. That’s a 3,500% increase from the $2.7 million that it had raised during the same time period last year.

Now that the ice has melted, all eyes will be on the organization to see how they spend their windfall. People will want to know where did the money go, and what’s the social return on the investment.

I (K.W.) think most people chose to participate in the ALS Ice Bucket Challenge with the intention of raising money for finding a cure to this debilitating disease. But they may be surprised that only 28% of its funds go towards research. I know that I was. I was challenged publicly on Facebook by several friends including a family member whose father-in-law was living with ALS (and subsequently passed away from this horrible disease). There was definitely social pressure to participate or else risk being seen as not caring about ALS. That couldn’t be farther from the truth. ALS is a terrible disease and it’s heartbreaking to watch someone you know deteriorate and ultimately die from this death sentence.

Every day we are being bombarded by causes and events to support, like everything “pink” in October, Movember, charity races, extra $1 at the grocery store, and so forth, and it can be difficult to decide whether or not to donate. There are a few great resources available to help decipher how organizations spend their money such as: Charity Watch; Givewell; and Charity Navigator. It’s about having access to information to make informed choices, just like deciding whether to take the latest prescription drug or have the recommended test.

With all this being said, it’s hard not to be amazed at something that raised over $100 Million. It was a brilliant marketing strategy and model for modern fundraising. I can guarantee that non-profit organizations everywhere are trying to emulate or find the next big social media fundraising strategy. According to Plenty Consulting, a firm that specializes in peer-to-peer fundraising, the ALS Ice Bucket Challenge worked because it hit a sweet spot: accessible and fun; an understandable, compelling cause; and “social proof” that if those I trust are doing it, I better join and support too.

Regardless if this was a one-time spike in fundraising for ALS, I certainly hope most of money is well spent and makes a dent in finding a cure while helping those who live every day with this death sentence of a disease.

Let’s keep track and make sure the ALS Association accounts publicly for the funds.

 

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SUBTLETIES OF PLACEBO http://sellingsickness.com/subtleties-of-placebo/ Tue, 09 Sep 2014 18:17:03 +0000 http://sellingsickness.com/?p=1498 Placebo response levels in many drug trials are high, especially with therapeutic areas that rely on patient-reported outcome measures. I (LT) recently read a very thoughtful paper by sexologist Andrea Bradford called “Listening to placebo in clinical trials for female sexual dysfunction” that opened my eyes to many important elements.(1) Since PRO measures are increasing in popularity during our current “lifestyle medications” era of pharmaceutical manufacture, it seems important to unpack the placebo phenomenon.

Typically, one thinks of a placebo as a “sugar pill,” an inert substance that modifies behavior, but not through any specific pharmacological impact. But this is overly simple. For one thing, new studies show that placebos do have physiologically measurable results. For another, “nonspecific” effects due to placebo and “specific” effects due to drug may be additive, interactive, or competitive – we don’t really know.

More importantly, the trials conditions under which drugs and placebos are administered (e.g., pre-trial publicity about the “great new drug” that hypes expectations, interactions with staff that focus the trial subject’s attention on one aspect or another, self-monitoring due to checklist or diary instructions, inclusion/eligibility criteria to get into trials) act as placebo elements themselves – encouraging, educating, and including people most likely to show positive results while excluding others. This biases the results of the trials. The point is that no one ever studies these factors and they remain invisible, yet everyone realizes how influential they can be. It’s absurd when you think about it.

Bradford explores at length the important interactions of perceptible physical changes and expectancies in the placebo effect. If a trial subject expects the active drug to produce some sort of subjective effect and the placebo not to, this expectancy will affect her response and totally influence the alleged objective “blinding” in the trial. An “active placebo” is a new idea – giving the placebo some side effects that won’t affect the behavior under study, but will give the trial subject a sense that something is going on. Also, debriefing study stubjects to find out which condition they thought they were in is important to see if the blinding was effective.

To me, the placebo effect is the 800 pound elephant in the room when it comes to drug trials on PRO areas such as sexual dysfunction. We must get the FDA to pay more attention!

 

(1) Bradford, A. (2013) Listening to placebo in clinical trials for female sexual dysfunction. Journal of Sexual Medicine, 10: 451-459.

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