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Abbvie Corp (Abbott successor to Humira promotion) "Welcome to the Humiraverse"

August 16 2013 at 10:58 AM
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http://davidhealy.org/welcome-to-the-humiraverse/

Welcome to the Humiraverse

Editorial Note: This post in the AbbVie series is by Johanna Ryan from the RxISK Community Advisory Board

I recently read a legal complaint filed against AbbVie by a New York woman named Cynthia Di Bartolo. Shes a successful corporate lawyer who had undergone various treatments for psoriasis over the years, including medications and ultraviolet light therapy. In November 2008 she started Humira injections on the advice of a dermatologist, Dr. Cui.

Whats a little red patch between friends?

Five months later, a dentist spotted a worrisome red-and-white patch on her tongue and told her to have it tested immediately. It turned out to be squamous cell carcinoma, a potentially fatal skin cancer and it had advanced to the point that simply excising the sore on her tongue would not cure it. Instead, she had to endure a massive operation that sawed into her face and neck to remove lymph nodes and other surrounding tissue. The surgery and its aftereffects came close to killing her and she still faces the lifelong risk of recurrence.

This skin cancer was a known and confirmed, if relatively rare, side effect of Humira. Its more common in patients like Cynthia who had previously had light therapy. However, neither the doctor nor AbbVie warned her of the risk. Had she known, she says, it is unlikely she would ever have agreed to take Humira.

Even if she had, she would have insisted on frequent follow-up visits to the doctor, and watched herself carefully for any sign of a skin lesion. Had the cancer been found earlier, it could have been treated with a much less drastic procedure. Now she can no longer work, struggles with fatigue and speech problems and has endured far more pain and disfigurement than her psoriasis would ever have caused her.

A duty to warn

You might think that Cynthia DiBartolo had an airtight case unless you know about a feature of American law called the Learned Intermediary Doctrine. This doctrine, accepted in most U.S. courts, holds that in most circumstances a drugmaker has no duty to warn the patient directly of possible adverse effects.

Its only duty is to properly warn the patients doctor the learned intermediary between drug company and patient who, its assumed, will determine whats best for the patient and tell her what she needs to know in language she can understand. This rule took shape long before the days of direct-to-consumer drug ads, but it has remained largely untouched in recent years. No matter what sales pitches companies use to lure patients, most courts have ruled the doctor is still the decider.

Cynthia and her lawyers dont agree that AbbVie did an adequate job of warning Dr. Cui and his colleagues about the risks of Humira. But beyond that, they contend that AbbVie offered physicians so many incentives to prescribe Humira that they fundamentally changed the doctor-patient relationship. These included everything from scholarships for aspiring dermatologists, to elaborate free continuing-education seminars, to actual cash payments for doctors willing to enroll patients in clinical studies of Humira that were actually little more than marketing campaigns. In that kind of environment, they argue, a patient like Cynthia can no longer count on her dermatologist to put her interests first.

In other words, the doctor that learned man or woman in the middle may have commitments to the drug manufacturer that equal or exceed their sacred commitment to the patient. Its an explosive charge, but the facts brought out by Cynthia Di Bartolo and her lawyers give it a lot of backing.

Humiraverse

Theres another issue touched on in the complaint, however, that may raise even bigger questions about AbbVies responsibility. Ive come to think of it as the Humiraverse a growing colony of AbbVie employees who establish direct relationships with the patient as well as her doctor. Some of the Humiraverses denizens are indisputably offering medical advice, while others are just getting awfully damned close. They include:

  • Patient Advocates employed by AbbVie who help psoriasis patients navigate the healthcare system. The advocates, were told, do not give medical advice but they do offer to be your go-to resource for psoriasis education and teach you how to have more productive conversations with your doctor. Thats a very fine line. Its not hard to imagine that, in the mind of an AbbVie Patient Advocate, a productive conversation with your doctor might mean Getting to Yes on Humira.
  • Your Advocate will also intervene with your insurance company to help you resolve your coverage and co-pay problems (which can be large and complicated when the treatment costs as much as $25,000 a year).  In many cases AbbVie will step in to cover your insurance copayment for Humira if you have trouble affording it. This can make a HUGE difference to the patient, but is arguably a no-brainer for AbbVie. If offering a $100 per month subsidy will enable a patient to get on a $2,000-a-month drug long-term, that amounts to a mere 5% discount.
  • Then there are the Humira Nurses RNs employed by AbbVie who will come out to your home or doctors office to teach you how to inject Humira correctly and help you get comfortable with doing this. The nurses are also available on a hotline you can call for help when your doctors office is closed. Inevitably, they will provide medical advice to patients whose Humira experience is going badly. What will they tell the patient with a serious infection who wonders if its linked to Humira? Will they advise patients to go to the local emergency room if thats appropriate, even at the risk of getting medical advice from outside the Humiraverse? And what would they have told a patient like Cynthia Di Bartolo, if she had called to report a small white bump on her tongue?
  • Until recently AbbVie also provided peer support via phone or email from Humira Mentors, who were alleged to be fellow patients on Humira volunteering their time to be your guides. These Mentors were pictured on the website with first names attached, much as the Patient Advocates are now, and you were encouraged to pick the one who seemed like the best fit for you. Noticing that resemblance, I have to wonder: Were they actually AbbVie employees, like the current Patient Advocates or were they really patients and volunteers as advertised? If so, why were they volunteering with the company that made their drug, rather than one of the many peer-to-peer programs run by groups like the National Psoriasis Foundation or the Spondylosis Association of America? And if you were having a rough time on Humira, would they be free to shoot the breeze with you about alternatives? The Mentor Program was shut down about six months ago and all mention of it was scrubbed from AbbVies websites.
  • Finally, theres the physician directory provided on AbbVies website, psoriasis.com, which will help you find the right dermatologist. It seemed obvious to me that these would be providers chosen by AbbVie for their Humira-friendliness. Just out of curiosity, however, I compared the providers offered in my area with the listings of dermatologists at the nearest teaching hospital. Only a couple of the seven dermatologists on the hospitals website were on AbbVies list of the right doctors.

Hey Doc: Are you in or are you out?

http://www.pharmaphorum.com']);" href="http://www.pharmaphorum.com/articles/implementing-innovation-in-pharma-overview-of-the-2012-life-science-forum" target=_blank>Take the Humiraverse tour.  All these services are huge incentives to the patient to start and stay with Humira and its also hard to deny that they insert AbbVie employees in between the patient and doctor.

But in my opinion they are also huge gifts to the doctor in the form of in-kind goods and services. The doctors and their nurses or PAs no longer have to do patient teaching. Their office staff no longer have to spend endless hours filling out insurance forms and arguing with adjusters (and this is a BIG personnel expense for most U.S. medical practices).

As a doctor you no longer have to deal with all the drama from patients who skip their meds because they cant afford the co-pays. Sweetest of all, no more after-hours calls from sick, cranky and frightened patients! The Humira Nurses will hold the fort for you until the patients next appointment. Thats not to mention the new business you may get from patients who found your name while searching a Humira website for the right doctor.

For a busy rheumatology or dermatology practice, this is like AbbVie providing two or three extra staff members free of charge. Its hard to overestimate the incentive this provides for the practice to use Humira. AbbVie is not alone in this most other makers of expensive biological drugs are getting into offering similar services. How can older generic medications, ultraviolet light treatments or therapeutic diets possibly compete even if they offer a better, safer option for an individual patient?

An alarming picture

On the one hand, the drug company builds a relationship with your doctor that may be strong enough to overwhelm his or her relationship with you, the patient. Is the doctor still a Learned Intermediary a sort of educated bodyguard standing between you and those whose only focus is to make money selling you medicines? Or are they a different kind of intermediary a conduit which the drug company uses to get next to you? Will specialist medical practices who sign on with such elaborate patient support plans someday end up branding themselves as Humira or Enbrel doctors, in much the same way insurance brokers now list themselves as Hartford or State Farm agents?

On the other hand, the company is assembling a team of healthcare workers who are drug company employees, pure and simple. Today they promise to lead you to the right doctor and help you have more productive conversations when you get there. Tomorrow they may replace your doctor altogether. When that happens, you will know you have been demoted from a patient to a customer. Or maybe a buyer as in, Let the buyer beware.

Stuffed into a corner of my bookshelf at home is a small political pamphlet I bought long ago, a red-hot indictment of what you might call the 1%.

The bourgeoisie has stripped of its halo every occupation hitherto honored and looked up to with reverent awe, it says. It has converted the physician, the lawyer, the priest, the poet, the man of science, into its paid wage laborers. 

Back in 1848 when this was written, Im sure that particular line struck a lot of people as wild-eyed paranoia. Im not sure I took it seriously myself when I first read it in the 1970s. Lately, I find myself pulling that old pamphlet off the shelf more and more, and wondering when someone will make a smartphone app out of it. It just seems that handy.

I know what Id say to the author if he logged on to the current discussion: Welcome to the Humira-verse, Karl. Does it look like you thought it would? Or are even you amazed?

http://davidhealy.org/welcome-to-the-humiraverse/" st_

- See more at: http://davidhealy.org/welcome-to-the-humiraverse/#sthash.lmiLYQk3.dpuf

Comments

  1. Just a technical note: Cynthia DiBartolos suit is actually against Abbott Laboratories, which spun off its drug division in January 2013 creating AbbVie Corp. Abbott was in charge at the time she took Humira. However, AbbVie is the successor to all the Humira promotion activities pre-2013 and continues them today, so I called the company AbbVie throughout.

    With $2.6 billion in sales for the first quarter of 2013, Humira is on target to reach sales of $10 billion this year, a world record. The stakes are high, both for AbbVies profits and patients lives.

  2. Anti-depressants, a parallel situation, are at world records highs for the most prescribed.

    Doctors have been warned repeatedly to stop bringing out the prescription pad.
    They are not doing this.

    We are in the midst of a cliff-hanger; do doctors, repeatedly prescribe drugs they know nothing about and force upon the patient, or do patients try and talk to the people that make these drugs.

    If, I was a young enthusiastic individual with more energy, I would almost have a revolution a revolt.

    I would organise every single person with an adverse reaction to a prescription drug, all over the world, to communicate their adverse event to the manufacturer of said drugs.

    I would then send in a reporter.

    I would just cut out doctors all together..

    I never thought the word genocide would occur to me, either, enough of that with the Jews, but is this really happening? OK, this is not mass genocide, but would you not think that perhaps 2 in 100, or whatever the stats are, the manufacturers would step in, to, perhaps, even discuss it.

    The silence is deafeningI was not herded into a bus on my way to be gassed, but I was herded into a terrifying situation, by my doctor. is silence a fabulous way to deny this?

    Do we understand why pharmaceutical companies refuse to talk to us, I think we understand very well.

- See more at:http://davidhealy.org/welcome-to-the-humiraverse/#sthash.lmiLYQk3.dpuf


 
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Abbvie employees acting as Patient Advocates direct with Dr and Patient...

August 16 2013, 11:13 AM 

with the AbbVie 'advocates' helping patients to see their way through the health care system and interacting with their GPs and helping with coverage from insurance companies - ergo AbbVie 'advocates' (AbbVie being Abbott's promotion team for the drug Humira)  infiltrating and influencing everything with direct contact throughout.

The "Humiraverse".


 
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WELCOME TO THE HUMIRAVERSE

August 16 2013, 11:19 AM 

(which I expect may become the Pharmaverse now that one lot have managed to get it and to successfully put a gagging order on the EMA)

http://davidhealy.org/welcome-to-the-humiraverse/


 
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Psoriasis Speaks: "Connect with an Advocate" Sponsored by AbbVie

August 16 2013, 11:44 AM 

http://www.psoriasis.com/

Offers a free Advocate. 

Offers "Expert Advice from a Dermatologist" (Dr Mentor, who surprise, surprise, is a "PAID CONSULTANT of AbbVie")

And videos from said Dr Mentor

http://www.psoriasis.com/dr-menter-videos.aspx

 

Don't really need to explain much more about industry experts other than a mention of the disgraced and corrupt Charles Nemeroff, who UK psychiatrists recently felt that they were now safe enough to openly invite over here as an honoured guest - and they were right, we HAVE hit rock bottom as far as science and ethics are concerned. 


 
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AbbVie UK: 'partner & collaborate with...universities...as well as other relevant groups'

August 16 2013, 12:05 PM 

http://www.abbvie.co.uk/research/index?culture=en-GB&trackingSelection=Ask

and they also set up AbbVie employed advocates, with direct relationships with GPs and Patients as shown in

http://davidhealy.org/welcome-to-the-humiraverse/


 
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"Other relevant groups".

August 16 2013, 2:25 PM 

What groups are "relevant" to industry for partnership/infiltration and collaboration/misinformation?  Lots of them. Could be any group that can influence opinion, judging from some of the posts at MumsNet after the recent Panorama programme with Professor Pilling on the upped risks of SSRIs in pregnancy. 

http://wp.rxisk.org/the-dark-is-for-mushrooms-not-for-women/

"

The Dark is for Mushrooms, not for Women

August 9, 2013 2 comments

The Pre-Pregnancy Puzzle

This post contains a comment by Neil Gorman on Humira in Ulcerative Colitis backed up by material criticising a BBC Panorama program on antidepressants in pregnancy retrieved from the link to Mumsnet mentioned by Neil. This link illustrates beautifully why Pharma has such an easy ride.

There is a mythic element here. Where men are accused of seeing women only as Madonnas or Whores, some women only see a Knight on a White Horse or a Dark-hearted Persecutor. Given this dynamic, tactically Panorama might have done better to have a NICE woman rather than a NICE man on Panorama talking about antidepressants in pregnancy.

TV Programs are a show. As shows, they may be true or not. In this case, Panorama was unquestionably true, and as Neil suggests even soft-pedalled the truth. The shows presenter is a significant advocate of womens rights. She defends every womans right to use SSRIs but she also believes every woman has a right to be told of the risks.

One of these risks is that while taking some antidepressants, some women are highly likely to become dependent on them and may not be able to stop them if they wish to become pregnant, despite ever more compelling evidence that these drugs cause birth defects and a range of developmental delays.

Perhaps the reason this issue causes feelings as heated as those below is that the problem is new. Its difficult to think of anything else that you could take while not thinking of pregnancy that might have such devastating consequences in the event of a pregnancy. Antidepressants in many cases are more difficult to stop than Heroin or Cocaine. They are more dangerous in utero than Heroin, Cocaine or Benzodiazepines. The data suggests they can have significant effects in pregnancy even when successfully stopped 6 months or more previously echoes of DiEthylStilbestrol (DES).

We need input from women on how to handle this Pre-Pregnancy Dilemma. Its often said there is nothing new under the sun well this one is new and is not readily solved.  

Please help.

(Ironically, as some of the contributors below note, SSRIs may take care of the pre-pregnancy problem by wiping out sexual functioning for ever see the many posts on PSSD in recent weeks Drugs and Sex Dont Go,  If a Drug Caused Blindness,  No Sex and the City. They also reduce sperm counts more effectively than anything else).

From Neil Gorman

There was a Panorama episode a few weeks ago about the dangers of SSRI drugs in pregnancy. I thought it was rather soft and narrow because of its focus on physical effects, leaving out the many horrible psychological problems that you certainly wouldnt want as a pregnant women. Still, at least it was some coverage of the dangers and that Prof Pilling from NICE seemed like a genuine guy.

Overall the programme was pretty ordinary and the argument that was presented for the use of SSRIs was the usual predictable tripe. You know, this old chestnut.

a recent review of scientific literature concluded that the drug does not appear to be associated with an increased risk of major foetal malformations.

The decision not to prescribe anti-depressants to a woman who is depressed may generate greater risks to the woman and her foetus than the risks of exposure to the medication.

Every time I read that well used and rather pathetic argument and then think of how the staff of pharma are supposed to be just like me, a little bit of sick creeps into my mouth.

But what really interested me was what was going on elsewhere at the same time as the panorama episode. Meanwhile over at channel 501, the Sky news team had discovered a story on a potential new genetic test for PND. It was big news, getting re-run every 30mins for the rest of the night. As you can imagine, the segment was about the dangers of depression to the mother and child and how catching it and TREATING it before birth with the aid of this NEW discovery, was just what we needed.

Of course this was not enough to defend against the already weak Panorama argument. RCPSYCH had already made the same defence that Lundbeck made above, and released the following statement before the Panorama episode hit the airwaves. http://rcpsych.ac.uk/mediacentre/pressreleases2013/panoramassrispregnancy.aspx

David said,
A new thalidomide could be happening now and companies would get away with it.

In my opinion it is already happening and they are getting away with it. Thanks to the likes of RCPSYCH and the corporate media doing what the money tell them to do.

Heart defects get past the pharma defence a little because of the horror of looking at a little baby wired up to a machine, or going for major surgery to fix a malformation is not that easy to cover upnot unlike the missing limbs of thalidomide. But the many other horrors inflicted on unborn children and their families, well they are not so noticeable, not so easy to measure, not so easy to prove. But many are no less horrific than a baby with a malformation.

So who won the battle of warning on the dangers of pills in pregnancy between Big Pharma/Corporate media/RCPSYCH vs BBC Panorama/Prof Pilling NICE

And what have UK mothers said?

http://www.mumsnet.com/Talk/womens_rights/a1787715-Gobsmacked-at-SSRI-pregnancy-thing-as-reported-on-BBC-today

Pretty depressing isnt it? Thalidomide is not only here, they have some mothers even defending it. You have to respect Big P, they play the game rather well.

 

Gobsmacked at SSRI / pregnancy thing as reported on BBC today

 NiceTabardMon 24-Jun-13 19:29:10

So a NICE Professor has claimed that for women who take SSRIs in early pregnancy, the risk of the baby being born with a heart defect rises from 2 in 100 to 4 in 100.

That is something that needs to be checked out, obviously.

What left me with my mouth hanging open was the scare-mongering approach which has been instigated by Professor Pilling, and his attitude towards women.

So first he compares taking anti-depressants, to smoking or drinking. While I am aware that tobacco and alcohol can be used by people with mental health problems, I really didnt get the feeling that he was making a point related to that. It came across as if taking anti-depressants was a lifestyle choice that women did for fun. The idea that women should be discouraged from taking SSTIs in pregnancy SSRIs is bizarre. Surely if there is risk, a warning should be issued to medical professionals to discuss options with women who are on these medications / thinking of starting a family etc.

The second was that he said that he flagged up this thing that right wing US types like about females being in a pre-pregnant state for their entire fertile lives.

Its not just when a woman whos pregnant is sitting in front of you. I think it needs to be thought about with a woman who could get pregnant. And, thats the large majority of women aged between 15 and 45.

So what, he is saying that women and girls should not have access to these drugs, which are highly effective, no matter whether they are single or in a couple, trying for a baby or not, or what form of contraception they are using? Thats a really concerning attitude and a dangerous road to go down.

The third was the huge risk he has taken saying this that lots of women on ADs are going to suddenly stop taking their medication. A woman with anxiety on SSRIs and in her first trimester might react very strongly to this. What with having anxiety and all. From this POV I find his comments irresponsible.

Nowhere in the article does it say, if you are worried dont stop taking your tablets but go and talk to your doctor. So that is a fail by the BBC as well.

All in all I was just really shocked by this. The way the Professor has approached this seems to have a total disregard for womens health or happiness. And implies that they take ADs as a lifestyle choice. He seems to feel that if women are aged 15-45, and only mildly or moderatly depressed, then they should just suck it up and get on with it, just on the offchance that they get pregnant.

Did you see this? What do you make of it?

TheJoyfulPuddlejumper

I agree with you.

I have a lifelong history of depression. The first time I had PND I refused to take anti-depressants because I didnt want it to affect DD through my milk. As a result I was in a bad way for a long time and planned my suicide several times. If pregnant women who are depressed are discouraged from seeking help by this professor they may end up in the same state I did, or worse.

As for pre-pregnant women he can take his misogyny and shove it somewhere unpleasant. Would he recommend that pre-pregnant diabetics stop taking insulin? Or that pre-pregnant epileptics stop taking their meds? No. What a twat.

NiceTabard

Im sorry to hear that, puddle. I have also suffered with anxiety/depression although they were triggered by pregnancy and I finally have just come off the drugs (DD1 is nearly 6).

There is enough stigma around this already esp. with pregnancy and young children and stuff I didnt go to the doc about it until DD2 was 2, I just struggled on as I was scared what impact me telling the doc I was ill would have on the children. This man obviously just hasnt considered the actual effect that his words could have on pregnant women who are depressed / anxious whether they are on medication or not.

I think that the way he has equated ADs with booze and fags, and said that women should be discouraged from taking them is bizarre. And the whole pre pregnant thing is just a revolting attitude, so utterly controlling and putting the tiny chance of something going wrong for a hypothetical baby before the health, happiness and autonomy of all females for much of their lives. Makes me spit.

scallopsrgreat

I saw that this morning. Found it disturbing on several levels. Lets make women even more responsible for their own mental health. Let them make impossible choices through pregnancy so we can blame it all on them rather than actually looking at what is wrong with the society that this is actually so much of a danger for pregnant women. And dont get me started on the pre-pregnancy guff. Are women to be permanently in a state of pre-pregnancy when they reach puberty? It is controlling and sinister.

I think it also ties in with the PND thread. Lets not sort out any support for women I this position lets just lay it back on them.  Back-fucking-lash

BlessThisMess

I have had one baby with a congenital heart defect while not on SSRIs, and two heart-healthy babies while on SSRIs. Those drugs saved my life, and I would hate to have been discouraged from being on them when I needed them. It was definitely not a lifestyle choice.

NiceTabard

Thing is if he had said that it looks like theres more of a risk and so HCPs should consider what is the best medication for the siutation as there are alternatives available etc etc then that would be one thing.

As it is he baldly states that SSRIs for all women with mild / moderate depression / anxiety aged 15 to 45 are not worth the risk to a hypothetical baby. No mention of the risk to the girls and women of not having this treatment available, no mention of weighing up the risk to the hypothetical baby against the risk to the actual woman who actually has actual mental health problems. No mention of alternatives.

His idea seems to be that ADs are a lifestyle choice that irresponsible women make, for fun. That is really strongly the impression he gives.

This man is a Professor working for NICE FFS not some random on the street. Presumably his area of expertise is mental health / pregnancy. And he comes out with this.

Sorry I am repeating myself it just made me so angry, glad its not just me. Its wrong isnt it. His attitude, reporting it this way, everything.

MooncupGoddess

Appalling and hot on the heels of the report suggesting that women shouldnt clean or use shower gel while pregnant. If there is evidence of SSRIs increasing the risk of heart defects then absolutely research it further and explain it to women when prescribing anti-depressants. But this scaremongering is unforgivable.

As a pre-pregnant woman I also get incensed that these articles take it for granted that most women of childbearing age a) are having regular PIV and b) would keep an unplanned baby.

NiceTabard

YY mooncup I was just thinking about that and looking for a link.

The advice IIRC was that women who are pregnant, or thinking or becoming pregnant, should not eat, drink or touch anything, ever. Or near enough.

I suppose Im also pre-pregnant even though have 2 children and would not contemplate having another child. Due to the MH issues I suffer when pg and afterwards. According to him I shouldnt have been given the SSRIs that made just such a huge, amazing difference.

Hmph. Had honestly not realised that I was pre-pregnant and that state should inform how HCPs treat me.

scallopsrgreat

His idea seems to be that ADs are a lifestyle choice that irresponsible women make, for fun. That is really strongly the impression he gives.

Yes that was the impression I got. It is very wrong.

I am really pissed off at the moment with the amount of dos and donts women are being subjected to during pregnancy. It has gone way beyond concern and information sources for pregnant women to downright speculation and misinformation.

It seems to me that the onus of reproduction is being firmly put on the woman and not on society. These thpe of articles are not asking the right questions and tackling symptoms rather than causes.

Why are we making products that are harmful to reproduction? I am not just thinking of SSRIs here but the other week it was cleaning products and non-stick frying pans FFS. Why are we not supporting pregnant women or women in general when they are depressed and looking at some of the clear links as to why depression is occurring in the first place (yes I am thinking of abuse, isolation, lack of support etc)? Why are fish so toxic that pregnant women shouldnt be eating them? The list goes on.

Raising child is a societal issue. But you wouldnt think it.

Manchesterhistorygirl

Ive never had to take ads, but wholeheartedly agree he can fuck the fuck off. Im technically pre pregnant and there is no way I would have another child, if it were necessary I cold be refused ads because Im a woman. Thats what it boils down to!

The state can fuck off. Im fuming about this state sanctioned misogyny.

scallopsrgreatMon 24-Jun-13 20:48:39

Cross-post with mooncup. Yes I was thinking of the same report. So vague you could probably put any household goods in there <rolls eyes>

MooncupGoddess

You should SUFFER, NiceTabard, for the sake of your hypothetical unborn child.

Given that women have a childbearing life of, on average, about 30 years it is an extraordinarily brutal sentence.

NiceTabard

scallops yes and another interesting point comes from that.

It seems (although may be selective reporting) that when there are potential problems with babies, it is the mothers behaviour that is exclusively focussed on.

Like them banging on for years about how older mothers = crappy eggs = how selfish poor babies. When actually older fathers = poor sperm quality = possible problems for babies / problems carrying to term but that is rarely mentioned.

With the chemicals thing AND the prescription drugs/ booze / fags isnt it entirely possible that these things will have an adverse effect on sperm leading to problems? Of course it is entirely possible and with smoking there have been studies showing it. Yet all of the focus in these things is on the woman.

Can you imagine if it were suggested that all pre-inseminating men so all males aged, what, 12 to dead, should not be prescribed SSRIs, should not be drinking alcohol, smoking, should be avoiding most thing that normally are used / consumed in day to day life?

scallopsrgreat

Brutal is the right word. Expecting women to be in a state of pre-pregnancy is just treating us like breeders. Not people with a right to a life.

Fuck. The. Fuck. Off.

HumphreyCobbler

bloody hell. Pre pregnant? He can fuck off

SunshineBossaNova

Pre pregnant? Only if he can fucking sort my DHs sperm out!

When we were TTC I specifically changed SSRIs on the advice of my gynae to ensure that any hypothetical babies were not harmed. No kids are forthcoming (aforementioned sperm problem) and I should be able to take whatever I fucking like.

The irony is that our fertility issues triggered HUGE depression for me but yeah, I was only taking them for fun. <mutter mutter mutter>

CaptChaos

Misogynistic twat.

SSRIs quite literally saved my life at one point, luckily (according to Prof Pilling) I had already been talked into getting myself sterilised, so never pre-pregnant again.

What a very dangerous and mother blaming piece of reporting as NiceTabard rightly pointed out, can you imagine the outcry should men be classed as pre-inseminating unless they are pre-pubescent or dead, and therefore should avoid the various things that women do?

MooncupGoddess

Actually there is some evidence (am not medic so cant judge it) that SSRIs can cause sperm quality problems in men that can be potentially linked to a higher risk of birth defects.

www.cornellpsychiatry.org/about/male_fertility.html

Bafflingly, I have yet to see an article on the BBC warning pre-inseminating men who are suffering mild to moderate depression not to use SSRIs for this reason.

NiceTabard

I assume that Prof Pilling has commented on that research though, mooncup?

I expect there is a piece on the BBC somewhere.

CaptChaos hold your horses there.

According to NHS, female sterilisation carries risk of 1 woman becoming pregnant out of every 200 procedures. Meanwhile condoms can be 99% effective. And being celibate, or being a lesbian, and not wanting a child, is to all intents and purposes 100% effective.

I didnt see him giving exemptions for any of those groups, so think you are being a bit presumptious there. I reckon the Prof would put you in a pre pregnant category without a second thought

OR maybe he has insight that women who are a. not involved with men and/or b. not having PIV sex and/or c. dont have or want children have a ZERO chance of mental health problems!

Could that be it?

MooncupGoddess

Good deduction, NT. I await a BBC headline saying Heterosexuality is bad for you.

TheDoctrineOfAllanTue 25-Jun-13 11:07:22

This makes me sad.

The idea of calling the next fuckwit who uses the phrase pre-pregnant a pre-inseminator makes me happy, though.

EldritchCleavage

Well, if I hadnt had SSRIs in my early thirties I would not have been alive to give birth to children in my 40s.

I share the annoyance and concern about this, but lets face it, women are routinely spoken to and about like this. Only recently they were subjected to messages telling them to avoid any number of everyday chemicals, foods and other stuff while pregnant, due to an unquantified risk of harm to the unborn child.

All responsibility and blame is placed on the pregnant woman, not on wider society to make changes that benefit and protect pregnant women and small children. This latest scare fits neatly into that pattern.

vintagecakeisstillniceTue 25-Jun-13 11:19:18

PRE-PREGNANT WHAT THE FUCK???????

So what does he suggest?
I hate to sound all Apprentice, but Im sick of these reports 99% aimed at women, that highlight these things but never a solution.

How many women will have gone on to have serious clinical depression with these meds?  Or does that not matter?  Silly me of course not theyre only women..

CaptChaos

I stand corrected NiceTabard and I, for reasons of being pre-pregnant at all times for the next few years, promise not to drink, eat brie/paté/peanuts/whatever todays no-no is, take any kind of SSRI or any kind of hormonal contraception.

Do you think that we, as women, should inform doctors and pharmacists that we are pre-pregnant when they write or fill an Rx for us? Should I only buy maternity clothing as a sort of just in case?

Honestly, the more I think of the concept of pre-pregnancy, the more I fume!

WoTmania

The more I think about this the more annoyed I feel. Two things really irk me:
1) mild to moderate < what if mild to moderate gets caught early, medicated and treated effectively rather than going on to develop into really bad.

Also, how do they guage it? Last time I went to the Dr with depression I didnt end up on a massively high dose but it helped. I also didnt tell the dr exactly how bad I was (suicidal thoughts. My 3 yo had walked in on me self harming) so probably got put down as mild to moderate. Had I gone when I first started getting low things wouldnt have got as bad iyswim but if this professor had his way I wouldnt have been prescribed anything.

2) I am a crap mother when depressed. Im in my early thirties so would be counted as pre-pregnant. Given the choice, and it should be my choice, between being a really awful mother and damaging my relationship with my children (and very possibly them emotionally) and not taking ADs or taking them and possibly harming a potential child I know which option I woudl go for.

LurcioLovesFrankie

OK, I too fumed at this article, because of the assumption that womens mental health was trivial and unimportant compared to that of their hypothetical unborn baby, thus making us seem like incubators on legs (once more).

However, I didnt see him use the phrase pre-pregnant anywhere. And it seems to me a reasonable part of informed consent to tell a woman that certain drugs are contra-indicated in pregnancy. After all, you dont have a statement in your medical notes saying I intend to get pregnant in the next 6 months/ I hate the whole idea and never intend to get pregnant. So the doctor has an obligation to consider the possibility and inform you that hypothetically, were you to get pregnant, there could be problems. I didnt have a problem with the endocrinologist I saw telling me this about my thyroid medication many years back, and I dont see a problem with a doctor discussing the issue with a woman presenting with depression depression does not remove your capacity for informed consent, nor for the need for the information required in order to give or withhold that consent.

The important issue is to tell women that SSRIs change the risk of congenital heart defects from (if I read the article correctly) 2 in 100 to 4 in 100, and ask her how she feels about that increased risk balanced against the risks posed to her of not having her depression treated.

The issue for feminists is to make sure that the decision making process is not taken from the women and handed over to the doctor, in the form of a blanket ban on SSRIs for pre-menopausal women (and Ive seen nothing in the press coverage to suggest that this was being proposed). After all, even if it increased the risk from 2 in 100 to 98 in 100, its perfectly acceptable for a woman to say give me the SSRIs, if I become pregnant and the 20 week scan shows a heart defect, I will have an abortion secure in the knowledge that I made the right decision for my own mental health. (By the way, I am not saying that this is the only decision, or the decision which is right in absolute terms I have close friends who have chosen to carry a baby with a serious heart defect to term, and that decision was right for them; I just believe very strongly that only the woman who is pregnant can make the decision about her own pregnancy).

HeartsTrumpDiamonds

Lurcio I agree with a lot of what you said (wrote?). Isnt it sad that pregnant women are only faced with what seems to be a litany of Donts and Mustnts with no real consideration of alternatives.

Wouldnt it be better if NICE could say, look, SSRIs are not ideal in pregnancy but look, here is another AD that is just as effective and will not cross the placenta.

One of my favourite rants is if men got pregnant they would have solved it by now. In spades.

SunshineBossaNova

Lurcio while I agree with most of what you wrote, some of us on long term meds (not just ADs) talk to our doctors before TTC. Its galling that, yet again, women seem to not be considered as sensible enough to talk with their GPs prior to pregnancy

PlentyOfPubeGardens

According to this report one in three women and girls are on antidepressants at some point in their lives.

I wonder what would happen if all pre pregnant fertile women stopped taking them. I suspect the country might grind to a bit of a halt

LurcioLovesFrankieTue 25-Jun-13 14:01:15

Hearts my mum had an even better version of that: If men got pregnant, abortion would be a sacrament (and lest anyone think she was joking, just think of the mental hoops theologians are prepared to go through over the concept of the just war).

Sunshine I totally agree its when medics think that women somehow cant be trusted with something as complex as informed consent and need to be told what to do, with a blanket ban in case we somehow damage the precious bundle of cells that might or might not be present, that the trouble sets in. And they tend to do that a hell of a lot.

Plenty Ive always wondered how much of the higher prevalence of mental illness in women could be blamed on the patriarchy. For instance, my sisters GP put her on SSRIs. Giving her leaflets about WA and the support of an authority figure saying actually, violence is never OK, and helping her to leave her abusive husband would have been far more effective in my opinion.

WoTmania

Lurcio he doesnt use the exact phrase pre-pregnant but what he does say is:

Youve got double the risk. And for women who are mild to moderately depressed, I dont think that those risks, in most cases, are really worth taking he said.

Its not just when a woman whos pregnant is sitting in front of you. I think it needs to be thought about with a woman who could get pregnant. And, thats the large majority of women aged between 15 and 45

To me thats basically the same as saying all women are pre-pregnant.

HeartsTrumpDiamonds

Oh, well thats a relief then. I dont need to come off my mood stabilisers even though Im only 42, because I already went through early menopause when I was 38. Phew.

Oh FFS I just realised Im actually 43!!! Clearly getting older not wiser.

Ragusa

I completely agree with lots of the stuff on here about his comments being ill-judged, and seemingly anti-women.

I am on SSRIs, have been for many years, believe they have sorted me out. Generally, I am a big defender of pharmacological agents for depression. I have practically rattled at times

However. and I just cant shake this what if feeling SSRIs have been linked to higher rates of heart defects. Presumably the studies demonstrating this have been adequately controlled for other comorbid factors.

While I believe his comments are careless, he may have a point that other drugs may confer more benefit and less risk. SNRIs for example have been shown to be more effective for treating depression than SSRIs.

I think its important to keep in mind that big pharma doesnt have a glowing record on showing its workings and being honest about potential side-effects. Ditto its data on the effectiveness of marketed medicines.

SunshineBossaNova

Ragusa Im on an SNRI. It works brilliantly for my anxiety and depression, but the withdrawals I wouldnt recommend them to anyone on that basis (google FDA discontinuation syndrome cymbalta).

NiceTabard

Ragusa thats all well and good but youre giving the benefit of the doubt with no reason.

if you watch the interview, read the piece, there is no mention of alternatives.

Maybe he thinks that is taken as read (?) or maybe not, I dont know, its not been reported. What is in the news, that interview he gave, is going to prompt a real response in some women in stopping their meds NOW.

If he didnt mean to come across like that, if the BBC reported wrong, there would be changes to the article, right?

But there arent. And importantly there is still nothing at the end / elsewhere which says please dont just stop taking meds please talk to your doc first etc.

So that to me says he has no qualms. If he was being misquoted etc he would have said (not like he wouldnt have checked himself out on BBC) and they would have corrected. Not happened. Ergo Prof not arsed.

I know that many people want to see the best in people but seriously, watch the interview (clip in in BBC link above) and read the link.

Josie1974

Sorry! I completely agree with you OP. I read the story and thought exactly the same as you.

The underlying message seemed to be that fertile women are baby-making machines who should live their entire lives to minimise any potential risks to a foetus they might possibly conceive regardless of the effects on them

Ragusa

Well, that was just daft, then, if he didnt even refer to other possible treatments. And careless. I couldnt watch the interview.

Why not write directly to the prof concerned?

Oh, I see there is going to be a panorama prog about this on 1 July 2013. Itll be interesting to see whats said on that.

 

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Industry and Other Relevant Groups... Mumsnet

August 16 2013, 2:32 PM 

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August 16, 2013 Leave a comment

Editorial Note: Two comments from Johanna and Neil in response to The Dark is for Mushrooms and Preventing Precaution

Johanna

I didnt see the BBC Panorama show (not available in the US) and dont know if the outrage expressed by the Mumsnet blogger is sincere. It hardly sounds like Dr. Pilling was against using SSRIs for any woman physically capable of getting pregnant. In any case he didnt propose to ban anything; he simply thought we deserved to (gasp!) know the facts.

But I think Neil Gorman is on the right track: if you just talk about the (physical) harms to the fetus and say nothing of the (mainly mental and emotional) harms to the woman, you miss the point.

And you hand the microphone to the drug companies to accuse you of discounting womens concerns, treating us as mere containers whose welfare should take a back seat to even the slightest threat of fetal harm.

The flip side of course is the HUGE exaggeration of the benefits of these drugs (and the unsupported assertion that depression itself will physically harm the baby). Thats the key to understanding the whole pre-pregnancy issue. As a woman, I should absolutely be the one to decide what risks to my future fertility or the health of possible future children are acceptable. But it depends entirely on what the benefits are and if Im being force-fed a wildly inflated notion of my own mental illness and the drugs benefit, I am deprived of free choice. Especially once you get me hooked.

The latest edition of Our Bodies, Ourselves, the pioneering feminist health guide put out by the Boston Womens Health Collective, took a much different tack on SSRIs and pregnancy. They did not take the birth-defect issue seriously enough in my view. But on the subject of what are the roots of prenatal depression and what can women do about it, I thought they were spot-on and their thoughtful rebellion against Pharma orthodoxy deserves to be publicized and celebrated.

Just a snip:

Too often women experiencing reasonable responses to difficult life situations are treated by health care professionals with mood-altering medications that can have unwanted side effects. These medicationswhose popularity is fuelled by simplistic and unrealistically optimistic advertisingare often prescribed before women are offered more holistic approaches that have been demonstrated to be equally or more effective.

Its not unlike the example of the woman in her late twenties raising 2 or 3 kids alone who wonders why shes just not interested in sex these days - and the expert who wants to test her testosterone levels! Apparently nothing could be all that wrong with our lives and the choices were given. No, if were unhappy with our lot, we must have a disease   This approach, while pretending to empower women, is actually the most controlling and disempowering I can imagine.

I knew mommy blogs had become a lucrative industry with worrisome commercial ties that threatened their just-folks sincerity. But I never saw the like of NetMums. They are a marketing monster in the UK it seems - there was just a Product of the Year competition juried and sponsored by them along with The Sun, Womans Own Magazine and other big-time outlets.

Funny thing too GSK won. Not for their Rx drugs of course for Sensodyne toothpaste. Seems theyve had relationships with Netmums around other consumer brands like Ribena kiddie drinks, etc. Siobhan Freegard, their Czarina, makes Oprah look like just a regular gal speaking her mind I dont think theres a single blog in the US with commercial clout of this sort.

That being said, I cant know whether any of the posts by individual women in their chat forum were in any sense sponsored material. And my hat is off to Edam, Ragusa and others who had the guts to point out that Big Pharma is not exactly an agent of womens liberation!

Neil

A few interesting little things I noticed but didnt include in my original post. The reason I found this particular discussion on Mumsnet was down to a Google search for the keywords Panorama ssris pregnancy.

No matter the combination of related keywords, RCPsych tend to dominate the first page with their response, either from their own website, or one of the many others that carries their statement or at least parts of their statement. Their SEO guys rock!

You dont have to go off the first page of results to the see a  pattern emerge. I see it as a two pronged approach:

1. A general scientific/expert defence that is carried out by Lundbeck and RCPsych. To me this appears to be coordinated, with both citing evidence from recent well designed trials (as opposed to all those old badly designed ones that Professor Piling is reviewing), and both also go on to reassure women that the risks are very low, uncertain even, before finishing with the very real risks to mum, baby and family if depression goes untreated. I have found this argument replicated dozens of times since the Panorama program from both Lundbeck and RCPsych.

2. The womens rights approach. Mumsnet isnt the only place this argument has taken place. Still on page one of my search is the Daily Mail. Slightly different readership demographics and so a slightly different approach to the issue, with the rights of women with mental health problems to have children taking centre stage here.

Best rated comment. 102 likes

Actually zenia, some of us are unable to control our serotonin production in the body and need the medication to functiongranted being depressed isnt a great thing to bring a baby into but are you seriously telling me because i was born with a disability i do not deserve to be a mother?? having a disabilty such as depression is something that is hard enough without being told your not good enough to be a parent i have been taking my medication through out my pregnancy but have been very closely monitored via the hospital and i have done everything i can to protect my daughter to ensure nothing will hurt her so grow up you silly silly women or child which ever you are. being a mother is any ones right not something you have to earn through perfect genes the next time you feel your perfect enough to comment on such matters firstly

2nd best rated..100 likes

Yay something else for depressed mums to feel guilty about. I am of course being sarcastic.

Back on to mumsnet and some other things I noticed. The Gobsmacked post wasnt the only one on mumsnet talking about Panorama, just the only one to appear in my google search. I didnt spend much time looking but found a few others. One was in the antenatal section, as you would expect but had a mere 8 replies.

Another was in the chat area . Here you can read an interesting set of posts by opensesame74. You can follow her through this discussion and then to the feminist one.

And yet another was an official post of a guest blogger added by Kate at Mumsnet HQ.

http://www.mumsnet.com/Talk/bloggers/a1794554-Guest-blog-pregnancy-and-antidepressants-a-womans-right-to-choose

This discussionOP and responses, reads very like the one in the feminist section, covers all the same points, but the language is much softer and it carries the impression of being an officially sanctioned part of Mumsnet, with a nice graphic, pale blue background and a long, well written guest post. Of course it is cross linked to the unofficial harsh version by NiceTabard.

Once again the star of this discussion is edam, who gives me some hope.

Its not hard to find evidence of a link between pharma marketing departments and websites like mumsnet. I obviously cant prove anything without GCHQ or Prism type powers, but I can show how plausible it is. If you want a peek at how pharma think about websites such as mumsnet, you can go to the pharma marketing society websiteyes, mumsnet gets a mention!

http://www.pmsociety.org.uk/article/trust-reputation-and-social-media-in-healthcare-the-patients-view-report

Some interesting stuff here, there is even a list of software to help you identify, listen, engage and respond to influential people on these social networking platforms.

If you had the time to read all that, and have digested the different code compliant strategies pharma marketing use to engage with these social networking sites, then take that thought back with you to mumsnet and do an internal search for popular antidepressants to see how often they are discussed you get some interesting results.

  • Citalopram - About 2,570 results (0.16 seconds)
  • Celexa About 122 results (0.11 seconds)
  • Effexor -  About 90 results (0.14 seconds)
  • Venlafaxine About 377 results (0.29 seconds)
  • Seroxat - About 490 results (0.19 seconds)
  • Paroxetine About 206 results (0.14 seconds)

And there you have a plausible link with Lundbeck Like I said, it proves nothing but it is interesting.


 
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