If you want proof that gratitude and good will is viral, look no further than Silicon Valley. Below is a Facebook stat showing the reach of some of my posts and their ‘virality’ (nearly died of laughter when I saw this word! :)) Anyway, the point is, anytime I’ve said ‘thank you’ to a ‘Liker’, given kudos or something away, ‘reach’ and ‘virality’ stats have shot up….& I’m happy to see a really relevant condom ad was the only exception ROAR :)!!!
So…take gratitude and ‘thank you’ with you everywhere and know that the web is like money, neither good nor bad, but if you spread ‘thanks’ on it….it’s all good. Therefore acknowledge, compliment and thank…you know …all the old Dale Carnegie stuff…it’s all part of the Law of Attraction.
So thank you for visiting OnlineCounsellingJamaica.com
I went to a Christmas afternoon do of the kind my mother used to tell me about – a basket, ballroom dance party…probably one of the best fetes I’ll go to for the Season…courtesy of the Port Antonio amateur ballroom dance group led by a former Arthur Murray instructor. Knock out, drop dead pool terrace venue overlooking the Rio Grande (Jamaica) Valley. All sectors of society present, including the more unusual and happily becoming more usual social cross section.
So let me tell you the value of ballroom dance in changing headspace…one member is female, a tiny, fit, 61 yr old new entrepreneur who has just left a soul killing 22 yr relationship…she now has what the Spanish call and absolute RABIA (route word ‘rabies’ :)) for her newly learned dance skills. Three males are young men from humble beginnings, trained in IT and out of work for now. The little lady decided she’d found a way to keep them out of trouble…AND HOW… To see these boys now is awe inspiring…we still have to work a bit on dress and grooming to acquire the polish of the ballroom but the head space and skill is there! This is a good, solid intermediate group of lads who can look a dance partner squarely in her Tango eye and lead her. They see themselves as male, accomplished and leaders…oh happy day…the key ingredients to the healthy male psyche. Check out the younger men, older women pairing…nothing to it and they call her Auntie, but ‘it don’t look like no Auntie/Nephew business’ when we cut the rug, I can tell you. There is a healthy element of fantasy that translates – switces the headspace into believing you can be and do more, be bigger than you are…and we, tangoed, waltzed, merengued, jived, congaed and socaed!!!
I kind of dropped into the party by accident because of my mile long reputation of having a rabia for dance in general and my experience of it. Weeeellllllll…there stood I on the fringes of the dance floor when one of these lads spotted me and raised the traditional macho ‘come here’ hand beckon. I looked at him out of one eye and asked who he thought he was and admonished him to note that ballroom dance required manners and etiquette…he swept me into the circle and informed me the Tango was a man’s dance…I raised my eyebrows in amused disbelief and warned the lad not to ‘fly past his nest’. It is a rare thing to see Jamaican marginalised males ‘step up’. This little phrase and movie title is really what dance is all about for men. It is a legitimate way to elegantly lead the female sex without threat to her modern ego and absolutely play to her biologically programmed wish to be led by a man. It is ‘safe sex’ allowing not just physical but the more erotic mental interaction many women crave and to which few men pay attention.
The men who vociferously poopoo ballroom dance are the same ones who become intensely jealous of those who want to dance with their women…dance is inherently sexual and we all know it consciously or unconsciously…the more comfortable you are with sexual identity the more easily you ballroom dance. Jamaicans’ history with ballroom dance is an exact metaphor for our sense of self, especially our men…we were avid dance partners till the late 60’s/early 70’s…now that skill has disappeared…we are fractured mentally…and though it used not to be, homosexuality is a new terror to us as well…all part and parcel.
So my advice is, if you want to improve your mental and physical health…find a ballroom dance groups. It:
Is great exercise, re calories and improving coordination (grace, Usain is graceful is he not?!)
Usually ends up getting you to clean up and be nice to be near (grooming)
Is safe sex
Teaches men they can lead by guidance and not force
Creates a safe environment in which women enjoy being led
Gives the brain new learning work
Opens up your social circle, etc., etc.
Don’t just go and jump into any and every group, find a style and group that matches your personality like you would find a friend, doctor, etc., etc. One size never fits all so go watch a few sessions of groups you’re considering joining FOR FUN…
Are they laughing and chatting and getting on together?
Are they happily bumbling through mistakes?
Is everybody equal and treated with respect?
Is it a level you can manager?
Is everybody HAVING FUN?
Don’t make the mistake of taking on sessions in a studio oriented to pros if just plain old fun is your aim…the atmosphere in these venues is RADICALLY different. So get out there and shake a leg…!!! Long live The Dance…! If the world does end, I’ll die happy doing it :)!!!
(Of course that cap would have to come off as we progress:))
I have understood that the western horoscope birth chart is real – a blueprint, but Vedic & Chinese charts are more accurate even. Day to day western horoscopes have yet to convince me. There’s a catch to using the western birth chart. If you know the negatives predicted by them, in my experience, they can implant and self-fulfill. Don’t seek the chart, if a skilled and trusted practitioner should tell you (s)he can help you, ask for your positives only and let him/her work to help you with the negatives such that you don’t know what they are but are being helped anyway, via prayer or life advice.
Re the practitioner him/herself, (s)he gets caught, it’s almost too much knowledge …in the sense of don’t touch the tree of knowledge… every single GREAT western practitioner has had SERIOUS Achilles’ heels…Jung, Goodman, Hippocrates, you name them…so I am finished with my personal quest with it and sealed or burned the findings and now look to ‘the Force’ of the Universe only …to me…God.
Two weeks after an unusual sequence of events I got a feeling I should go out into the demi moonlight and sit on my favourite garden wall. I looked up and, dead overhead, my sign and rising planet in conjunction, and I knew two things, a) it would be just about midnight 2) the heavenly body and constellation ‘were crossing something’…I checked it all out later and was right, at midnight, Dec 2/3 the rising planet crossed the ecliptic (?). I checked astronomically, not astrologically…I have chosen never to know if this event/transit has a meaning…
When I had looked up, I was called to say the Our Father and meditate. It was one of my two most ‘shiftingly’ powerful meditations…water, not light, poured down into my chakra system, and much as I asked where the light was, none came, the water kept pouring…and my Guardian Angel (yep, ‘he’ has a name which I don’t write) rose up to monstrous size behind me, not frightening, the vision was given to me in dimensions that weren’t fearsome. He was there ‘to get my back while the cleansing occurred’…apparently being cleaned spiritually also leaves you ‘naked’ a while… I have since meditated a few more times and my last meditation was a breakthrough…I saw my electric blue dot for the first time in roughly 10 years.
On a more physical note…I wonder if we have understood the literal meaning of the planetary ‘line up’ correctly….Look at coordinates 78:18 about 3.30pm Dec 22 (what’s a day when you’re calculating millenia, remember the Mayans had to make up the solar cycle the way we use a leap year :)) 2012….the heavenly bodies look virtually stitched into a perfect swath on the ecliptic…is this a coincidence? See it below…
I wish you an awakening at ‘the Shift’…the Mayan calendar marks it and so does the Chinese according to which latter, we are at the end of the longest ‘out of synch’ calendar cycle that Chinese time measurement can register…it’s a 60 year cycle in which elements are mostly incompatible and that comes around once every however often…so I wish you smooth sailing, fair winds and following seas…THE TIME IS NOW…do something special tomorrow…for yourself…anything from a relaxing walk, to meditation, to thanking someone, to leaving life as we holy fools understand it…
Vamos a empezar con una lista de encantos sin ningún orden en particular: –
violetas azucaradas (los verdaderos)
cosa seria cuando se trata de zapatos finos … los españoles le mira de ‘abajo arriba’ para decidir si viene de ‘algun parte’ :)!
chocolate con churros
Catedral de Santiago
Fast almacen alemán en la Navidad
la calle Serrano
‘Jamaica española’ por Morales Padrón
pollo Asado y Cidre
aceite de oliva
acceso a Europa
Cafe Circulo de Bellas Artes
Penélope Cruz, Javier Bardem, Antonio Banderas
Manitos de Plata
vinos de Rioja
siesta (aunque esto fallezca :()
Ahora, con verrugas y que sea, considero este lugar como mi casa arquetípica. Camilo José Cela dice que es autofagico (me encanta/odio de La Familia de Pascual Duarte) y eso es la verdad, quiero decir de vistazo a su historial medioambiental con los hoteles grandes allí y en Jamaica, pero hay esperanza, ¿quién habría pensado que las corridas de toros se harian venido bajo el fuego y los Vinos Torres ha tomado en cuento, muy gravemente, la incorporación del “verdor” en sus prácticas de cultivo. (Me disculpe la gente aficionada de la corrida, se que es ‘sangre de Espana’ esta actividad)
Y cuando todo esté dicho y hecho, tuve una vision que me ha marcado para siempre y un sueño ‘agro’ asociado sobre Jamaica suroeste, la su zona todavia mayormente libre de crímenes en que gente espanola de mente ecológica y de comercio justo vengan y lo utilizen para cultivar la aceituna y la uva jerez y nos enseñen a hacer el aceite y el jerez. Te lo juro, si has visto las llanuras de Santa Isabel de Jamaica, y usted conoces Frontera y Andalucía, sabria que es un clon pequeño de las zonas secas espanolas del sur y por lo tanto ideales para la agricultura no tradicional …. y se puede imaginar el de mercancia!!??? Aceitunas y el aceite y jerez, cosecha Marley/ Bolt!! Carcajada!!
To what extent do daughters escape/not escape maternal influence? My mother/me: in Europe on honeymoon feeding pigeons/on the other side of ‘the Pond’, speaking at a health conference, acknowledging the condom. Karma plays out within the metaphysical memory & progression of Universal Mind. There is absolute infallibility, and often humour, of synchronicity in telling psychological, temporal and historical tales. When I saw the picture of me, it rang a bell and I remembered the, to
me, iconic photo of my mother (my father to her right, cropped & no one beside me, cropped :)). She is not left-handed.
…And is the common ‘m’ for mother and capitals for ‘My’ & ‘Me’ a Freudian riot or what? I roared & left the ‘error’.
Her dress & matching shoes & bag were the bees knees…
HIV has always hit where it hurts the social conscious most. It runs parallel, like no other health condition, to the ills of society and our personal lives. My association with it has been an odd one – an issue that circles back into my consciousness at regular intervals.
I first knew of it when I was studying nursing and the school did a great job defusing the bomb – it was an illness that was more likely to cause us to do harm to our patients than they would likely do harm to us. I was involved in the first research for HIV nursing policy for the NYC Health & Hospitals Corp. Barrier nursing and move right along… so I never had a morbid fear of it, just respect. Then I had a boyfriend in New York who had a crack addict brother and in those days (late 80s) they were still sorting out the dangers of tears and saliva so I decided to get tested. The lab personnel back in Jamaica wanted to know why someone like me would want to get tested…apparently this still happens in some places even today. Next, I took on the HIV education of our surgeons in training at the request of their consultant. Then I left it behind a while …until med school. Before entering, I went to a convent to pray about the rightness of my decision to take up medicine rather belatedly. Kneeling in front of a statue of Mary (the Catholic representation of the ancient goddess archetype), I got this message, clear as day, “The generative force of the universe has been bastardised”. I knew it referred to HIV, STIs & abortion, but what was I supposed to do with this knowledge? I still don’t know. Then …the day…as a senior student helping out a nurse suffering from ‘short-staffedness’, I stuck myself with an IV needle while trying to canalise an obtunded patient with AIDS. I had forgotten one part of my universal precautions and recapped a needle. I remembered the rest; bleed, wash with soap, get on therapy within 2 hours, draw baseline blood, report to consultant. Fear and the ART nearly killed me, inflamed kidneys, dizziness, nausea, starlights in my abdomen, yeast…at day 11 (the earliest theoretical day seroconversion could occur), having talked to 3 mentors and returned to the convent, I made my peace with God and discontinued the therapy I should have been on for 1 month. I tested at 3 mons., 6 months and the year. Negative. To date, Jamaica has had no conversions from needle injuries. I left it behind again and then almost by luck of the draw, got invited to the Chicago Midwest Caribbean Assoc.’s HIV/AIDS Awareness Day to present the Jamaican situation. I thought I’d seen and heard it all… but not like this.
First of all, I recalled Carolyn Myss’s book, Anatomy of the Spirit …HIV is a disease of victim mentality…is her thesis. There it was, the population that day was a range of full Caucasian to full Negro and everything in between and we were American Negro or Caribbean immigrant any and everything. A minor representation of American Caucasian in positions of power matched and superceded, in this forum, by non-Caucasion people in power and no Australoids or Mongoloids. Mongoloids present a paradox. One group, the Asians, were not present because their social structure is strong enough to preclude high rates of HIV and another group, the Native Americans was absent because it is so marginalised that it was not represented at all. Therefore, a near exact ethnic map of maginalisation was manifest. The main speaker of the day made the essential connection. To live with, beside or inspite of HIV, you have to take the chains off your brain. All ignorance, intolerance, prejudice and judgementalism has to die first…which led me to the real eye-opener.
The degree of interracial, interethnic, international interaction; tolerance; candour and live-and-let-live is something I’ve never seen the like of before. Personal horror stories are the norm, rites of passage are inescapable, ‘overcomings’ are astounding. There was mild and gentle side by side with militant and wild, each had its role and place. The interpersonal discomforts were acknowledged by some and put aside by all in the name of the cause. Everyone had sacrificed time and money to be there.
I saw and heard who had been cheated on, who born with it, who had had wild sex, who had come from the gutter and jail to the pastorship and married heterosexually on the way, after having a years long same sex relationship…all the dirty laundry of our real lives was on parade with forgiveness and acceptance. Previous rape, incest, abuse and addiction of the challenged was the common path. An entire generation has now grown up with HIV/AIDS and our national experiences are as similar as the details of these experiences can be stunningly different. Women are getting the short end of the stick everywhere, but IV needles will never play a part in one country. The more Negroid the population in the Americas the more HIV, but where any ethnic or racial group live in marginalized circumstances, rates are comparable with the exception of the Australian Australoids…they are blessedly and paradoxically marginalised enough that they have no extra exposure and virtually aren’t represented in any forum.
…So is this what HIV is here to teach us…? That we are more/better than the physical manifestation of our beings? …And what a comment that we needed such a lesson… Furthermore, suffice it to say, when I get a new diagnosis to deal with, should they need it, I automatically give them 3 months sick leave for medication adjustment time.
As the Midwest Caribbean Assoc points the way to the next stage of the HIV challenge, this is how I symbolize the transition and some interesting connections I made:
The wonderful Franco-anglo-hispanic panel I sat on
My panel is ‘four videos long’ on my Youtube channel, OnlineJamaica. With the kind assistance of the Midwest Caribbean American Association, I was here on a panel to bring a perspective directly from one of the English Caribbean territiory’s governments and its foremost learning institution, The University of the West Indies.
Two of the the day’s events were documented in seven 15 min videos on Youtube and below is the 4th in the series – the first pertaining to the panel in which I took part. It was such a good feeling being part of something so universally Caribbean – I’d never been to a forum in which all the Caribbean’s base cultures were represented – GREAT LEADERSHIP on the part of the Midwest Caribbean Assoc. We need FAR more of it, in every sphere & walk of Caribbean life! The other play list documents David Robertson’s presentation (3 videos long) – a quite remarkable young man & HIV/AIDS survivor. He got me, first and foremost proving to me, Carolyn Myss’s theory that HIV/AIDS is a disease of victims…this young man has left the victim role…and most look like him once they’ve turned their barks on the victim role…sometimes it takes a long time and some never make it…but those who do, laugh, smile are smart & warm & reach out way beyond themselves. And we uninfected people really buy into the victim business because I remember being stunned at what those who were leading happy, fulfilled lives looked like despite the expected percentage who succumbed to the cushingoid habitus. There was even a happy-go-lucky little fellow who was 23 and diagnosed at 2 years…it’s with us People, we could as well all ‘get with the programme’! Real love and respect and safe sex…
Divorce is always sad, but does it have to be a knock down drag out disaster that resembles Scorched Earth retreat strategy? It is a common a right of passage today so why not re-think what we do to and for each other when we divorce? Are we to think vengeance and murder or should we try to ‘Live and Let Love’.
I interviewed a many years divorced and re-married woman whom I thought should have written a book on her handling of this difficult passage and here are her tips and secrets for ‘keeping it as together as possible’ in the middle of the storm. The most common break up periods are after the 1st, 21st and 15-16th years of marriage. The last one is usually the most messy. There are frequently adolescent children involved. What to do?
The fact is, there are some prerquisites for ‘a decent divorce’ and the main one is the upbringing of the divorcing partners and whether they’ve been left with a healthy self-esteem or not because, like it or not, it is the odd divorce that doesn’t lay siege to self-esteem. When this esteem is threatened, most of us are not very nice to whom we think of ‘the enemy’. The reality is that more divorces happen among people with unfulfilling and/or deficient upbringings and poor support systems. These kinds of people find it harder to tap love and altruism as they proceed. However, this fact does not mean they have no point of reference for creating a ‘live and let love’ experience. We can always all make the effort to use free will and choose the Golden Rule: ‘Do unto others as you would have them do unto you’.
And the basic tips:
A) Decide if the marriage can/should be saved, if not you will have to hold your nose and jump. ‘Trial’ separation is normal but there is no such thing as ‘nearly divorced’ if you have to go that legal route
B) Check your self-esteem, upbringing and support systems and find your personal anchors. Include prayer or recognise that there are forces greater than yourself which direct life.
C) If this fails, use the Golden Rule and use external foci to guide you:
1) If you have children, focus on the best for them and it will help define your behaviour
because there will usually be some nastiness, even in the most amicable of situations.
2) Foster and value precious moments with them
D) Attempt to admit both parties have made mistakes and sublimate the essentially selfish act of divorce to the kindness of releasing something that has gone irrevocably bad or was wrong in the first place. If the fault is largely yours, have the grace to act accordingly.
E) Switch off the business of ‘the woman is wrong’ if you are leaving because staying would mean, and I quote, ’emotional death’.
F) Try to support each other’s weaknesses…and if there is one, as far as possible, leave the other man/woman out of your personal deliberations. In most, but not all, cases, (s)he is not the solution to your problems but the symptom.
G) Promise yourself that only if you are not working and will be the chief custodian of your children, have a terminal/chronic condition, etc., etc., should you even think of taking more that 50% of your partner’s income and goods, no matter what the law allows.
H) Sublimate yourself and let the children vent and blame you…accept the blame and take their very common but wrongly assumed sense of guilt from them. They are not guilty and must know it. Bend over backwards to reassure them of your love and support.
I) Children often do better if they are with their parents during this tough time, only send them away if mental or bodily harm is a possibility. Take your breaks from them if necessary but if you send them to boarding school, or grandma etc., for the long term, they may be scarred for life.
J) Use all the backup from B) above to go through the tunnel to the clover, it will be dark sometimes. You may be the only one of the partners who thinks of the higher good.
K) We are all different, what works for one will not work for another and the lady I interviewed tried meditation and counselling and they weren’t for her. She determined her divorce would be something of which she would eventually say, ‘This too shall pass’, so she kept a madly intense journal of her inner angst called her ‘Misery Chronicles’ and when she felt she was sailing in fair winds burned the journal, symbolically erasing that chapter of her life.
Yes I know, easier said than done and now that the lady has had a chance to learn about what is really involved in marriage, she is under no illusion that it is easy nor would she do it again but she believes the rewards are greater than the trials in a working marriage and would not change her life of her new husband for anything… Like one couple told me, “Murder? Oh yes, divorce, never!” 🙂
An RD special report takes a look at pharmaceutical manufacturing and how
new drugs receive FDA approval. By Alexis Jetter April 2008
Crisis in the FDA
Recent headlines have uncovered one shocking lapse after another at the Food
and Drug Administration: A popular diabetes drug can sharply increase the
risk of heart attack, a finding the agency knew but took two years to
reveal. An FDA-approved antibiotic can destroy your liver in just five days.
And despite mounting concerns about the safety of Chinese-made drugs, the
agency had only enough field inspectors last year to check a mere 13 of the
714 Chinese factories that produce medicines for U.S. consumers.
Many of the nation’s leading doctors, scientists and lawmakers now agree
that the FDA is in crisis. Lurching from one disaster to another, the
102-year-old agency learns of dangers too late and then moves too slowly to
remedy them. Insiders say it’s woefully underfunded, dangerously
understaffed and fractured by bitter internal tensions. Instead of depending
on the FDA, Americans are doubting it — and for good reason.
The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines,
medical devices, blood and tissues, radiation-emitting machines, animal
feeds and drugs, cell phones, dietary supplements, biotechnology and gene
therapy — and, post-9/11, sniff out any food-borne terrorist plot. Yet the
agency’s annual funding, $2 billion, is about what Fairfax County, Virginia,
pays for its public schools.
“Think your pacemaker, heart valve, microwave oven or morning vitamin was
inspected?” asks former associate commissioner William Hubbard. “Dream on.”
A chilling new report commissioned by the FDA’s own advisory Science Board
describes an organization nearly out of control. “We were shocked at the
appalling state of science at the FDA,” says Garret FitzGerald, MD, chairman
of the pharmacology department at the University of Pennsylvania School of
Medicine and an advisor on the report. “The analogy is Katrina. But we have
to fix this before the hurricane hits.”
Drug safety is perhaps the greatest concern. The respected Institute of
Medicine, created in 1970 by the National Academy of Sciences, recently
labeled the FDA’s drug branch “dysfunctional,” saying it muzzles scientific
dissent, inadequately monitors drug safety and relies too heavily on drug
Even the department’s champions are worried. “I don’t think the FDA is at a
collapse point yet, but it’s getting close,” says Hubbard, who retired in
2005 after 26 years at the agency. “In some places, regulation is so weak
that there’s nothing left.”
The agency’s most recent difficulties began in 2004, when officials came
under fire for silencing a staff scientist who had concluded that
antidepressants could increase suicidal behavior in teens. That same year,
the FDA was criticized for not acting quickly to take the painkiller Vioxx
off the market after it was shown to increase the risk of heart attack and
“Every generation has required some health disaster to reform the FDA,” says
David Graham, MD, a drug safety expert who has worked at the agency for 24
years. Today, he says, that window of opportunity has been pried open by
debacles such as Vioxx. Former FDA commissioner David Kessler, MD, agrees:
“These are the times when things get fixed.”
Congress has begun that job. Last September, lawmakers did increase the
FDA’s funding by $145 million, although only about one fourth went to the
drug-review branch (more on that later) and boosted its regulatory powers.
Observers hope FDA officials will use their new clout to restore the
agency’s lost luster. But they say the public needs to weigh in to make sure
that happens. Here, the five key problems, what’s being done to fix them and
how you can help.
5 Key Problems With the FDA
. Problem: Pressure From the Industry
There’s pressure to speed decisions, and there’s pressure to soft-pedal
problems. That means drugs may go on the market without adequate vetting —
or follow-up. Critics of the FDA like to say it’s the best agency the
pharmaceutical industry can buy. That’s a political jab, and agency
advocates say it’s unfair. “The extraordinary efforts of these committed
staff members are the very reason further catastrophic food-and-drug events
have been averted,” an otherwise scathing review by the FDA’s Science Board
concluded last November.
But most agree that there’s at least a problem of perception, and perhaps
more than that, caused by the growing chunk of the agency’s budget that
comes directly from drug companies. Industry dollars now pay for more than
half of the FDA’s drug-review budget; in five years, that proportion is
expected to jump to 70 percent.
Called user fees, this $400 million a year is designed to speed decisions on
applications for new drugs. “User fees seem to save taxpayers money,” says
Susan Wood, PhD, the former assistant commissioner for women’s health at the
FDA and now a professor of public health at George Washington University.
“But they undermine public confidence in the FDA’s independence and impose
time pressures that could end up costing lives.”
Faster approval of drugs, of course, is a very good thing if you need a
lifesaving medicine. Many patients are clamoring for that speed. Review
times have been cut from 27 months to less than a year. Vioxx was
fast-tracked in just six months. But some argue that the pendulum has swung
too far. “A lifesaving drug should be sped along,” says Steven Nissen, MD,
chair of the department of cardiovascular medicine at the Cleveland Clinic
and a frequent advisor to the FDA. “But with user fees, we’ve pressed the
accelerator on all drugs, and that’s a mistake.”
Here’s the danger: “The easiest way to make those deadlines is not raise too
many questions and just accept what the drug companies say about safety,”
says former FDA drug reviewer David Ross, MD. Too often, Dr. Ross says,
reviewers tell their FDA supervisors that a drug doesn’t work or has a major
safety problem and “managers come up with contrived reasons to approve the
drug anyway.” He says the standards of safety and efficacy have slipped to
the point that the drug reviewers “can end up approving almost anything.”
No one can say that moving drugs more quickly from the laboratory to the
pharmacy always puts Americans at risk. But there is a smoking gun: an
alarming spike in adverse drug reactions reported to the FDA recently, from
267,000 in 2000 to over 471,000 in 2006. And the number of reported deaths
has nearly tripled, from 5,519 to 15,107. That’s only part of the story: The
agency estimates that it learns of fewer than one in ten drug reactions.
Janet Woodcock, MD, the FDA’s deputy commissioner and chief medical officer,
flatly denies that user fees and sped-up approvals compromise safety. “The
FDA is legendarily tough — our requirements are viewed as a really tough
bar to get over.”
“The review standards have not changed one bit since the introduction of
user fees,” says Alan Goldhammer, PhD, deputy vice president for the
Pharmaceutical Research and Manufacturers of America, the drug industry
lobby. “We’ve been careful never to compromise the independence of the FDA.
Congress would not permit it.”
Nevertheless, says Dr. Woodcock, “I understand that there’s a perception
What’s Being Done
Congress slightly increased the FDA’s drug safety budget last year but
accomplished that mostly by boosting user fees once again. To help offset
that influence, and enable the FDA to tackle all its other responsibilities,
reformers say Americans should pay 3 cents a day to fund the agency, rather
than the 1.5 cents we now pay. The agency’s Science Board argues, “That’s a
great price to pay for the assurance that our food and drug supply is,
indeed, the best and safest in the world.”
. Problem: Safety of New Drugs
When the FDA approves a drug or medical device, staff scientists must, in
effect, make a judgment call about its safety. They’re relying on industry
studies that usually follow between 600 and 3,000 people, often for just a
few months. Those small clinical trials are designed to measure a drug’s
safety and effectiveness in a targeted group of patients — not the dangers
the drug might pose when it’s taken by people with a wide variety of
backgrounds and health conditions. “If it kills one in 2,000 people, or
makes one go blind, you may not see that in the trial,” says Drummond
Rennie, MD, a deputy editor of The Journal of the American Medical
Association (JAMA) and a professor of medicine at the University of
California, San Francisco. “You start adding that up, and that’s ten in
20,000 going blind, and that’s a lot of people.”
Those risks are revealed only after a medicine goes on sale and has been
used for months or years by hundreds of thousands or even millions of
people. Keeping track of those reactions is called post-market surveillance,
and experts say it’s one of the most important phases of drug testing.
Historically, user fees were not allowed to go toward checking the safety of
drugs once they were on the market. And until now, those follow-up reports
haven’t been mandatory. A 2006 report found that 65 percent of the studies
that drug firms promised to conduct in recent years hadn’t even begun.
What’s Being Done
Congress authorized the FDA to spend $25 million from user fees this year to
improve drug safety. But agency insiders say that’s not nearly enough.
“You’ve still got a mismatch,” says Hubbard, who is now a senior advisor for
the Alliance for a Stronger FDA, a group that includes seven former agency
commissioners and three former Secretaries of Health and Human Services.
“You still have all this effort going into getting the drugs on the market,
and not much going into making sure they’re safe once they’re out there.”
On that issue, Congress got tough last year. The FDA can now require
companies to trace the long-term effects of their drugs. If firms renege,
they face stiff fines, up to $10 million for repeat offenses.
Another crucial reform: Companies can no longer treat the results of
clinical trials as trade secrets. Until this year, a manufacturer could
cherry-pick what it revealed — publishing a favorable study in a medical
journal and sticking less rosy findings in a drawer. A report in the January
New England Journal of Medicine revealed that one-third of antidepressant
drug trials are not published, which can mislead doctors into thinking the
drugs are more effective than they really are.
Here, too, Congress has drawn the line: Companies must post results of
clinical trials on a public database, ClinicalTrials.gov, within one year of
their completion. Independent experts should soon be able to evaluate the
findings and better inform doctors and consumers about what the studies
mean. Unfortunately, companies can wait three years to post summaries
written for the general public.
That new measure of openness draws kudos from Dr. Woodcock, the FDA deputy
commissioner. “People volunteered for those trials, and their lives may have
been altered as a result,” she says. “They deserve to know that their
information has contributed to society.” Having such full disclosure about a
treatment or device is the only way to know what medical research means for
all of us.
. Problem: Sloppy Record Keeping
For an organization whose core function is gathering and analyzing crucial
facts quickly, the FDA’s partially computerized database “is like something
that came off the ark,” says Dr. FitzGerald, the Penn pharmacologist and
Companies are required to tell the FDA about any severe reactions they learn
of, and do so within 15 days if the injuries are life-threatening. And the
agency operates a website called MedWatch (www.fda.gov/medwatch), where
doctors (and patients) can download a form to report problems. But few
physicians bother to use it. The result: Only a small fraction of adverse
reactions get passed on. Even more important, the FDA doesn’t have the time
or money to make sense of the information it does receive.
The agency is notified of half a million problems each year, a third of them
serious, says Dr. Woodcock. Most of those reports arrive via paper fax and
have to be sorted by hand. More worrisome, the FDA’s skeleton staff of 35
report analysts have only eight minutes to read even the most serious case,
says Hubbard, who tracked such things as associate commissioner.
“We’ve never had enough resources to really do the job and hire the staff,”
says Dr. Woodcock, who has been at the FDA for two decades. “And it’s not
that we didn’t try.”
What’s Being Done
Congress has responded, telling the agency to invest several million dollars
to connect to large medical-records databases run by the Veterans Health
Administration, Medicare and HMOs. Using these databases will allow the FDA
to better track and analyze adverse drug side effects. That means the FDA
will know much sooner if a newly marketed drug needs to be relabeled or
pulled off the market, even whether one medication works better than
another. And thanks to Congressional intervention, the agency will now be
able to make label changes quickly, without prolonged negotiations with the
. Problem: Conflicts of Interest
The FDA’s advisory boards, which vote on drugs and devices, are intended to
represent a broad spectrum of physicians, researchers and patient advocates
— not stockholders. But a study published in JAMA in 2006 found that in 22
percent of advisory board meetings, more than half the members had direct
financial interests in the companies whose medical products they evaluated,
or their rivals.
The agency says it’s doing the best it can. Because drug companies
underwrite most clinical research, even at universities and hospitals, some
say it’s difficult to find top medical experts with no ties to industry.
What’s Being Done
Congress has decided to roll up the red carpet. Over the next five years,
the FDA will have to cut by 25 percent the number of advisory committee
members with financial ties to a product under review. Consumer groups had
hoped for an outright ban but say this is a step in the right direction.
. Problem: Muzzled Experts
Dr. Graham, in the FDA’s drug safety office, says that a few years ago he
was ordered to soften his assessment of a drug he thought should be
withdrawn because it could cause liver failure and death. “Industry is our
client,” a supervisor told him.
“It may be your client,” Dr. Graham says he replied, “but it will never be
When told this story, FDA spokeswoman Julie Zawisza said, “Our client is
really the public.”
Still, other agency scientists share Dr. Graham’s concerns. Drug reviewer
Rosemary Johann-Liang, MD, suggested two years ago that the diabetes drug
Avandia carry a black box on its label (the agency’s strongest warning),
alerting patients and doctors to its cardiac risks. Instead, Dr.
Johann-Liang says, her supervisors reprimanded her and deep-sixed her
Last August the agency did finally issue an urgent warning about the drug
and placed a black box on its label. But by then Dr. Johann-Liang had
resigned — and millions of Avandia prescriptions had already been filled.
Many agency staffers say they’ve felt similar pressure to soft-pedal product
dangers. In a poll of 1,000 FDA scientists, conducted in 2006 by the Union
of Concerned Scientists, 20 percent said agency decision makers had asked
them explicitly “to provide incomplete, inaccurate or misleading information
to the public, regulated industry, media or elected/senior government
officials.” And 40 percent said they could not publicly express concerns
about public health “without fear of retaliation.”
The tone has been set from the top. Last year Andrew von Eschenbach, MD, the
FDA commissioner, told a roomful of staffers to stop making their gripes
public. “If they don’t follow the team,” he said, “the first time, they’ll
be spoken to; the second time, they’ll be benched; and the third time,
they’ll be traded.” (FDA spokeswoman Zawisza says Dr. von Eschenbach has no
desire to limit dissent.)
The tangled story of Ketek, a once-promising new antibiotic, illustrates
what can happen when the agency’s scientists feel marginalized.
What’s Being Done
Last year Congress created the Office of Chief Scientist of the FDA, to give
staff members a forum for debates and improve the quality of research. The
new law also gives in-house staffers the right to publish their critiques in
medical journals and makes sure their assessments, even if overruled, are
made part of the public record.
Money alone won’t solve the FDA’s morale problem. In recent years, dozens of
career scientists and senior managers have left the agency, a much higher
turnover than that of the National Institutes of Health or the Centers for
Disease Control and Prevention. Public trust in the agency has slid from 67
percent in 2001 to 36 percent in 2006.
Without change at the top, longtime agency watchers say, there’s no
assurance that officials will get tough on industry scofflaws. In fact, from
2000 to 2005, FDA enforcement against drug, vaccine and medical device
manufacturers dropped by more than 50 percent, according to a recent
investigation by California Congressman Henry Waxman.
A discouraging sign: One of the first regulations the agency proposed this
year is intended as a shield, according to some Congressional leaders,
designed to protect drug companies from lawsuits brought by people who
believe they’ve been injured by drugs or medical devices.
But having stronger tools and the right leadership could gradually restore
the FDA to what it once was — a highly respected band of medical
detectives, apolitical and immune to corporate pressure.
There is one bright spot on the horizon, says Jerry Avorn, MD, a professor
of medicine at Harvard Medical School and an expert on the drug-approval
process. “There is more public awareness of this issue than I’ve seen in 30
years,” he says. “And that can help put the agency’s many smart, dedicated
people back into the driver’s seat. Because a lot of this is really not
about very arcane science. It’s about common sense. And that’s what’s been
missing, until now.”
And then…see what you make of the big business-federal waltz….supplied by Dr. J. Mercola’ s website. http://media.mercola.com/ImageServer/public/2012/january/study1-big.jpg
This article is special, it matters that people are accountable and names are supplied making it very different from most articles I’ve seen.
You might be hypochondriac, but then again you might not… There are quite a few illnesses for which suffering patients get called hypochondriac…I will only list some of those I’ve experienced in my practice…and I’ll tell you…sometimes an ‘unrelated’/rare set of symptoms points to a completely undiagnosed ailment/condition or a wrongly/under treated ailment.
1) Dermatoses ranging from immune conditions to infestations
3) Bladder diseases
5) Pain of any kind
6) Abdominal pains
7) Dietary deficiencies
Don’t be afraid to get that 2nd opinion! Even if they won’t release your file! If you’re a genuine case, you deserve to be heard…move on to who will listen! Check yourself too:
1) Do you really want to get better?
2) Have you really been trying?
3) What emotional issues are you grappling with?
4) Do you need counselling?
5) Can you take your practitioner sure fire proof? Like your husband’s video of your trance, for example, or some research you’ve done on your condition.