Guest Post by Steven Miller

(This is the 1^st of three guest blogs by Steven Miller about Obama’s BRAIN Initiative and Wall Street’s broader agenda of privatizing all aspects of medical treatment and research. In this post, Miller describes a parallel process in which Big Pharma used their relative monopoly on anti-retrovirals to exclude third world countries who were the most severely impacted by AIDS. )

On April 2, President Obama announced the next step in research of the human brain. This is the BRAIN Initiative – Brain Research through Advanced Neurotechnologies. The US government will finance research into the next generation of technology to map the human brain with $100 million in seed money. The next step is to develop new electrical, optical, computer-assisted technology to investigate how the brain works at the level of neurons to determine how they work and how they link up in neural networks.

The current level of brain research is already pretty amazing. Without invading the skull, scientists can map the areas of the brain, and even neural pathways, that respond to specific stimuli. For example, a given area of the brain will respond to stimulus by increasing the blood flow when it is being used. This area radiates more heat, which is easily detected.

When someone is shown a picture of their pet dog, for example, science can detect exactly which part of the brain activates. Scientists are thus able to detect which brain structures are involved when you dream, when you drive the car, when you fall in love or when you do your taxes. The brain, however, is perhaps the most complex thing in Nature. It has 10 billion cells that make 100 trillion connections. Getting down into the individual neurons and connections themselves offers the possibility of actually determining the structures of the mind, human personality and memory.

 These amazing advances will all be privatized. Corporations intend to claim parts of the brain as private property and sell access for a price. The privatization trend has been rampant in biology and medicine for 30 years.

Can You Own the Sun?

Polio epidemics swept the United States every summer in the early 1950s, terrifying families and entire communities. Sometimes whole birthday parties of kids would be affected, since bodily fluids in swimming pools could spread the virus. At the peak, in 1952, there were 58,000 new cases of children who were crippled or paralyzed.

 Dr Jonas Salk became an international hero in 1955 by proving that a killed virus could easily be made into medicine that could immunize people against the disease. By 1957, 100 million doses had been administered in the US. Treatment on a similar scale spread rapidly across the industrial world. In 2002, over 500 million children were immunized in almost 100 countries. Today the Americas are polio free and the disease is close to extinction around the world.

Salk was asked, in a television interview, who owned the patent. His famous response was, “There is no patent. Could you patent the sun?”

This response would be impossible today. Equally impossible would be the massive immunization rapid-response by the public. The single thing that prevents this sort of public health response is that corporations now control the development of science and medicine through patents. And, yes, they do intend to patent the sun!

 Fast-forward 40 years to the 1990s. Consider what happened with the next modern scourge, AIDS. After fighting the disease for 15 years, scientists had developed the cocktail of anti-viral drugs that would prolong life indefinitely by containing the virus. This time however the patents were all controlled by Big Pharma, the cartel of drug-makers like Pfizer and GlaxoSmithKlein. By that time, drugs now were the considered private property of corporations; thus they were protected by international treaties over intellectual property enforced by the United States.

 The public no longer had the right to use the anti-virals without paying billion-dollar corporations for them. As AIDS swept across Africa, India and Asia, these corporations, demonstrating once again their great concern for the improvement of humanity, offered them for sale for a mere $15,000 a year. They claimed that the drugs were expensive to manufacture. Besides, they reported, Africans could not use them effectively. Maybe that was because they lived on less than $2 a day.

In India, Dr Yusuf Hamied broke the patents and began manufacturing the anti-virals so easily that they were available for only $350 a year. Big Pharma responded with the true compassion that only corporate-persons can evince. They used their political power to force governments across the world to criminalize anyone who dared to distribute the inexpensive drugs. Some ten million people died as a result.

The response of the public to these police actions was so massive that the governments of Brazil and India were forced to declare that they would break the patents. Corporations could no longer control the distribution of generic AIDS drugs. Thousands of lives were saved. Big Pharma still works actively today to prevent the distribution of life-saving generic drugs today. (1) They innocently strive to maximize profit, even at the expense of human life.

 This is a terrible crime against humanity, one committed by corporate-persons against real persons. Such crime is inevitable when corporations control the resources of health, medicine, science, research and, in fact, any and all forms of technology.

NOTES

1) Democracy Now, “Fire in the Blood”, January 13, 2013

Steven Miller has taught science for 25 years in Oakland’s Flatland high schools. He has been actively engaged in public school reform since the early 1990s. When the state seized control of Oakland public schools in 2003, they immediately implemented policies of corporatization and privatization that are advocated by the Broad Institute. Since that time Steve has written extensively against the privatization of public education, water and other public resources. You can email him at nondog2@hotmail.com

photo credit: krischall via photopin cc

Crossposted at  Daily Censored

Elizabeth Fowler

There seems to be nearly universal agreement among self-respecting progressives (those to the left of Michael Moore) that Obamacare has been little more than a glorified corporate welfare bill for health insurance and pharmaceutical companies. Thus it’s little surprise that Elizabeth Fowler, the senate adviser responsible for drafting the bill (and killing the Public Option), has been offered a cushy job at the drug company Johnson and Johnson. Moreover before joining the office of Senator Max Baucus, the Democratic Chairman of the Senate Finance Committee, as the point person for the health care bill, Fowler was the Vice President for Public Policy and External Affairs  at WellPoint, the nation’s largest health insurance provider.

Glenn Greenwald nails this classic example of corporate revolving door syndrome in his recent Guardian article about Fowler’s finesse in using her government credentials in climbing the corporate ladder.

Read more here.

*Note: you’re unlikely to read about any of this in the US corporate media. They want you to think our elected representatives still run the country.

TPPA Protest in Chicago (Sept 2011)

My fifth and final post about the antiglobalization movement – and why it’s more important than ever in 2011.

Activists mustn’t be lured into a false sense of security by the collapse of Doha round of WTO negotiations. Globalization is very much alive and well. WTO tribunals continue to meet secretly in Geneva enforcing trade provisions that have already been agreed. Moreover after a two year hiatus, an informal meeting at the May G20 Summit in Paris has resulted in the scheduling of a WTO ministerial in Geneva in December 2011. The goal of the December meeting is to try to reach a “partial” agreement on the Doha round.

Even more ominous are efforts by corporately-controlled governments in the industrial north to coerce concessions out of smaller countries with bilateral “free trade” (see * definition below)  deals that strip citizens of their democratic rights and force subsistence farmers off their lands in Africa and Southeast Asia (to enable their sale to multinational agrobusinesses).

The TPPA: Say Goodbye to Generics

At present, both the US and New Zealand are at highest risk from the Trans-Pacific Partnership Agreement (TPPA), a nine country (US, Australia, New Zealand, Brunei, Chile, Malaysia, Peru and Vietnam) free trade treaty currently being negotiated with the US. Up till now, the US has been unwilling to negotiate a “free trade” agreement with New Zealand, owing to this country’s antinuclear policy, which denies US naval vessels access to our harbors. I find it frankly embarrassing to see our new National (conservative) government tart themselves up like a cheap hooker in order to trade away New Zealand’s sovereignty, economic sustainability and public health.

Dr Jane Kelsey, New Zealand’s foremost anti-globalization lawyer and activist, was among the protestors at the Chicago anti-TPPA kick-off rally over Labor Day. Other high profile TPPA opponents include Public Citizen, Knowledge Ecology, and Health Gap (international HIV-AIDS campaigners). The last two groups are extremely concerned about TPPA provisions increasing the monopoly rights of pharmaceutical companies, which will make it virtually impossible for low income patients (especially in developing countries) to access low  cost life-saving generic drugs.

Kelsey has written and spoken extensively about the TPPA, which first came to public attention in New Zealand thanks to a December 2010 Wikileaks cable. Although New Zealand’s National-led government still refuses to release the full text of TPPA, enough has been leaked by various sources to reveal that its bad news for New Zealand’s democratic system of government. Like the Multilateral Agreement on Investment (MAI), it guarantees special rights to investors and forces the repeal of laws that interfere with the ability of multinational corporations to do business in this country. This includes scrapping PHARMAC, our world-famous bulk drug purchasing agency (pharmaceutical companies hate PHARMAC because it forces them to discount their brand name drugs), as well as restricting New Zealand’s ability to put warning labels on cigarette packs and content labels on genetically modified foods. It would curtail their ability to regulate dodgy finance companies, as well as forcing us to allow mining in our forest reserves, fishing in our marine reserves and high rise hotels on our pristine beaches.

To follow TPPA negotiations and get involved in the anti-TPPA movement go to http://tppwatch.org/

*Free trade – describes an approach to international trade that allows traders to trade across national boundaries without any interference from respective governments.

*Fair trade – is closer to the original “free trade” concept (abolishing protective tariffs and quotas) promoted by Adam Smith in the Wealth of Nations. Smith advocated that wealth should flow naturally from richer to poorer nations, as a way of increasing innovation and productive capacity in both rich and poor countries. Fair trade is an organized social movement around a market-based approach that advocates for third world producers to be paid a fairer, higher price for their products, as well as higher social and environmental standards.

Sativex - marijuana by prescription

This is the last of three posts on ending the War on Drugs.

Unlike the federal government, states aren’t allowed to run deficits. Since the 2008 economic collapse, both Democratic and Republican dominated states have been extremely proactive in reducing law enforcement costs by enacting drug liberalization legislation. This mainly takes the form of laws legalizing marijuana use for medical purposes and laws reducing personal marijuana use to a misdemeanor punishable by a fine.

While marijuana decriminalization is typically associated with liberal Democratic states, it enjoys growing support in Republican states facing harsh budget realities. According to Mother Jones magazine, among Republicans, 61% support legalizing marijuana for medical use and 33% support total decriminalization. Approximately 50% of Americans overall support marijuana decriminalization. http://motherjones.com/politics/2010/09/tea-party-marijuana-legalization

Tea Party Support for Decriminalization

The Georgia Tea Party also supports decriminalization (http://www.facebook.com/topic.php?uid=115334838544068&topic=56), as does a Kentucky Tea Party group called Take Back Kentucky. The latter, who were instrumental in Rand Paul winning a 2010 Senate seat strongly back hemp legalization, in part as an alternative crop for tobacco farmers hurt by anti-smoking legislation (http://www.willowtown.com/promo/blogfpnov10a.htm).

Decriminalization to Reduce Budget Deficits

Fifteen states and Washington D.C. have passed medical marijuana laws. This includes a number of traditionally Republican states (Kansas, Alabama, Tennessee, Nebraska, Alaska, Montana, and Nevada). Sixteen states (Alaska, California, Colorado, Connecticut, Maine, Massachusetts, Minnesota, Mississippi, Nebraska, Nevada, New York, North Carolina, Ohio, Oregon, Pennsylvania) have passed laws making any marijuana possession (and in some states cultivation) for personal use a misdemeanor offense punishable by a fine. The California law was signed by Republican governor Arnold Schwarzenegger before leaving office last year. Local authorities in eight other states (Arkansas, Illinois, Texas, Wisconsin, Montana, Missouri, Michigan and Kansas) have made marijuana possession a misdemeanor within city limits.

Eight states are considering bills to fully decriminalize marijuana. Connecticut, the first state to enact paid sick leave, is also expected to be the first make marijuana possession a civil offense, like a traffic ticket, punishable with a $150 fine.

Decriminalization Efforts in California

With marijuana its largest cash crop, California has the strongest decriminalization movement. At $14 billion annually, cannabis-generated revenue is double that of vegetables and grapes combined.

A decriminalization initiative on the November 2010 ballot was narrowly defeated (53.8% No to 46.2%). A recent analysis in the Nation attributed the defeat to a conspiracy theory circulating among pot growers and elderly users that the tobacco giant R J Reynolds was buying up land and planning a corporate takeover of California production and distribution once personal marijuana use became legal. This was despite an absolute denial by the cigarette manufacturer that have any interest in expanding into marijuana. http://www.thenation.com/article/157001/altered-state-californias-pot-economy

Enter Big Pharma

The rumors have some basis in reality, given the way Big Pharma has moved into the medical marijuana market. In 2007, the British drug company GW Pharmaceuticals announced that it had partnered with the Japanese company Otsuka to bring “Sativex” – a liquefied marijuana sprayed under the tongue – to the U.S.  Sativex recently completed Phase II efficacy and safety trials studies, and the manufacturer is in discussion with the FDA regarding Phase III testing. Phase III is generally thought to be the final step before the drug can be marketed in the U.S.

Sativex is already in use in Britain, Spain, Germany, Denmark, Canada, the Czech Republic and New Zealand.

Don’t Chop It – Expand It to Everyone for Real Cost Savings!

www.healthcare-now.org/

In my view, the only solution to the mess “corporatization” has made of the US health care system is to follow the example of other industrialized countries and establish a single, nationally funded health program. Like the American Health Security Act of 2011 that Senator Bernie Sanders and Representative McDermott introduced last month. Three decades of cost studies, including research by the Congressional Budget Office and America’s foremost health policy experts, show this could be accomplished quite easily by expanding Medicare. Under the Medicare program, doctors, hospitals and labs bill the federal government (instead of a private insurance company) for health services to seniors and the disabled. Expanding this program to all age groups would result in a streamlined, efficient system comparable to the Canadian Medicare program, in which doctors, hospitals, labs and pharmacies bill the government for the health services they deliver. US health providers, who currently bill hundreds of different private insurance plans, would simply bill Medicare for all patients, as they currently do for their 65+ patients.

This would immediately take nearly a trillion dollars out of America’s $3 trillion health care bill, as it would massively reduce the cut private insurance companies take for profit, CEO salaries, marketing, administration and billing. Under the current system, this administrative waste siphons off 31% of every health care dollar. In contrast to the 3.6% it costs to administer the Medicare program (see http://www.pnhp.org/single_payer_resources/administrative_waste_consumes_31_percent_of_health_spending.php).

Reducing the Cost of Prescription Drugs

The experience in other industrialized countries is that this model also drastically reduces the cost of prescription drugs. The purchasing power enjoyed by a single agency purchasing medications for millions of citizens forces pharmaceutical companies to agree to major cost concessions. In fact it is the one true example in health care delivery where market competition leads to price reductions – especially when four or five manufacturers are producing eight virtually identical drugs for the same condition. The main reason prescription drugs are so much cheaper in Canada and Europe than the US is because of the bulk discounts their hard bargaining has won from drug companies (in the US, the Pentagon and Veterans Administration use their purchasing power to negotiate similar bulk discounts).

It Works in New Zealand

This model works exceptionally well in New Zealand, where the government has set up a semi-autonomous corporation called PHAMAC to contain prescription drug costs (which are one of the main reasons developed countries are blowing out their health budgets).  This model works exceptionally well here, according to the 2004 Australian Health Review http://www.publish.csiro.au/?act=view_file&file_id=AH040171.pdf

In New Zealand, medications on PHARMAC’s approved medication list are subsidized, with the patient paying a $3 co-pay. The formulary consists mainly of generic drugs, where they are available, and for brand name drugs where the manufacturer has agreed to a volume discount. If the drug company won’t agree to a discount, the drug doesn’t appear on the PHARMAC formulary. One example is Pfizer, which refuses to discount the price of the antidepressant Zoloft. Because patients must pay the full cost of a Zoloft prescription at the pharmacy, it’s very rarely prescribed in New Zealand.

Obviously there are exceptions. If credible medical research indicates a new, non-discounted drug fills a distinct clinical need, it will be included on the formulary as a “special authority” drug. This means the prescription will only be subsidized if the doctor fills out a “special authority” application certifying that the patient meets specific diagnostic criteria and has failed to respond to one or two comparable drugs on the formulary.

The Envy of the Industrial World (and under attack – see * below)

Thanks to PHARMAC New Zealand, unlike most of the industrial world, has been relatively successful in limiting the growth of prescription costs to the rate of inflation – despite a significant increase in demand. As the Australian Health Review describes, its formation in 1993 was followed by near constant litigation from drug companies, which meant that legal costs accounted for 18% of its budget in early years. Drug companies complain that New Zealand is failing to pay its fair share of research costs, a claim I find pretty self-serving, given record profits the pharmaceutical industry reported in 2010 (averaging more 15-20% of revenue – see http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies), as well as the billions devoted to marketing “me-too” drugs and marketing (see my last blog), criminal penalties for fraudulent business practices (see http://www.huffingtonpost.com/2010/03/20/drug-companies-shrug-off_n_506962.html) and exorbitant CEO salaries.

Especially as the taxpayers funded the research, at the National Institutes of Health and Veterans Administration, for some of the pharmaceutical industry’s most profitable drugs (for example, Taxol and several HIV drugs). After covering the lion’s share of the costs (i.e. research), the federal government turned these discoveries over to drug companies to be mass produced – and earn them billions of dollars in profits.

*A recent Wikileaks cable release reveals New Zealand’s National-led government is contemplating scrapping PHARMAC as a condition of a new free-trade agreement with the US (see http://www.scoop.co.nz/stories/WO1012/S00643/wikileaks-no-quick-fix-for-pharmaceutical-market.htm).

http://scienceblogs.com

The drug companies and pharmaceutical industry analysts that pimp them claim that me-too drugs (see May 30 blog) are beneficial for the US health care system in two ways. First they allegedly lower prescription costs by increasing competition. Secondly they provide doctors a range of back-up drugs when the first-line medication doesn’t work or isn’t tolerated.

The claim about lowering prescription costs is utter rubbish, as copycat drugs are always priced the same or higher than the older drugs they supposedly compete with. And drug companies never, ever market their me-too drugs to doctors or patients on the basis of cost savings. The reality is that the price for brand name prescription drugs continues to soar through the roof. Only the ready availability of quality generics has kept prescription costs affordable for the vast majority of patients.

Moreover it makes no sense to apply free market competition principles to the prescription drug costs, as drug prescribing is never a standard market transaction. Nearly all prescriptions are at least partially subsidized, either by insurance or Medicaid. The heaviest users of prescription drugs are vulnerable geriatric, mentally ill and disabled patients who hold virtually no sway in making a price-driven choice between competing products. Even their doctors, who ultimately make the choice, must go to a lot of extra effort to ascertain price differences between brands, as drug companies don’t voluntarily provide it.

The Sad Saga of SSRI Copycats

To justify the value of providing doctors a range of similar drugs to choose from, most analysts give the example of all the copycat SSRIs available to treat depression. In doing so, they claim that some patients who fail to respond to Prozac, may respond to Paxil, Zoloft, Celexa, Przac, Priligy, Lexapro, Zelmid, Viibyrd or Upstene. This is yet another marketing claim with no scientific data whatsoever to back it up. After prescribing SSRIs for twenty years, I, like most of my colleagues, have never found a differential response to different brands. My own clinical experience coincides very closely to recent meta-analyses of three decades of SSRI efficacy studies: about 35-40% of patients (only slightly higher than the placebo response) get a positive response to any SSRI, while 60% fail to improve or experience horrible side effects (http://www.oregoncounseling.org/ArticlesPapers/Documents/TherapyVsRx.htm).

I agree with Dr Marcia Angell’s view (see May 30 blog) that having one therapeutic equivalent for a patient who develops and allergic reaction to the first drug invented in a therapeutic class – but approving eight is enormously wasteful (especially in view of the billions of dollars spent on marketing them), as well as posing major safety risks.

What the Congressional Budget Office Found

In 2004 Angell could only estimate what drugs companies were spending on marketing, as this is proprietary corporate information. However in 2009, the Congressional Budget Office (CBO) investigated and came up with the following findings:

• Drug companies spent approximately $20.5 billion on promotional activities (10.8% of total revenue) in 2008.
• In 2008, drug companies spent $38 billion on research and development (20%).
• Drug marketing costs, which grew at rapidly pace between 1988 and 2006 had slowed and had been steady for three years at 10-11%. The CBO felt this was directly related to decreased rate of new drugs coming to market.
• In 2008 drug companies spent only slightly more on promoting new drugs than they did marketing copycat drugs.

To be continued.

www.oldthinkernews.com

In addition to the billions of health care dollars drug companies waste on disease mongering – convincing the public that everyday human problems are  illnesses requiring treatment – billions more are wasted on developing and marketing hundreds of “me-too” drugs. By definition, a “me-too” or “copycat” drug is a very slight variation of a drug already on the market. The main downside of me-too drugs is that they are a primary factor in skyrocketing health care costs, which in turn, are the main reason hundreds of thousands of Americans can’t afford a doctor when they are ill. Other drawbacks of Big Pharma’s fixation with copycat drugs include the neglect of hundreds of untreatable fatal and disabling illnesses and hundreds of cases of premature death and/or permanent disability related to inadequate safety profiling. Nearly all the major drug recalls in the last few years have involved copycat drugs that were assumed safe because they were chemically similar to medications already on the market.

An Issue First Raised by Ralph Nader

To the best of my recollection, Ralph Nader was the first to raise the issue of me-too drugs in his 2000 presidential campaign. Dr Marcia Angell, Harvard Senior Lecturer in Social Medicine covers the subject extensively in The Truth About the Drug Companies: How They Deceive Us and What To Do About It (2004) and in “Excess in the pharmaceutical industry” in the Canadian Medical Association Journal http://www.cmaj.ca/cgi/content/full/171/12/1451

According to Angell, it’s quite common for a drug company to manufacture their own copycat drugs when their patent is about to expire on an older drug (which means most doctors and patients will opt for the cheaper generics that become available). She gives the example of AstraZeneca reformulating the ulcer drug Priloxec to bring out Nexium, a nearly identical replacement and then increasing the price of the Prilosec to get people to switch.

She then gives the example of three identical cholesterol lowering drugs – Provochol, Zocor and Lipitor – being introduced a few years apart following the immense success of Movochol. As of December 2010, we now have eight extremely virtually identical medications for the exact same indication: lowering cholesterol levels.

Billions Spent on Marketing Identical Drugs

Angell goes on to point out that of all the drugs the FDA approved between 1993 and 2003, 78% were similar to already marketed drugs. Even more shocking was that 68% weren’t even new compounds but a reformulation (change from capsule to tablet, short to long acting, etc) or a recombination of existing drugs (in psychiatry this is a common ruse to extend a patent on a brand name drug)

Angell is also extremely concerned about the billions of dollars drug companies spend persuading doctors (and now patients through direct-to-consumer advertising) that their new me-too drug is more effective or safer than the older versions on the market. This is done without a shred of scientific evidence to back up their claims, as the FDA only requires pre-approval trials to compare me-too drugs to placebo and not to existing medications. Occasionally drug companies will do a head-to-head trial with a competitor’s drug, but this is only years after approval. AstroZeneca, for example, spent $500 million persuading doctors to substitute Nexium for Prilosec.

To be continued.

Dr Peter Parry (see 5/21 blog) puts the blame for the dangerous fad of prescribing unapproved antipsychotic drugs for children squarely where it belongs: on drug and insurance companies. While internal memos (see http://www.blackdoginstitute.org.au/docs/PaediatricbipolardisorderacontroversyfromtheUSA.pdf – slides 91-94 and 98-100) show that drug companies conspired to persuade doctors to prescribe antipsychotics off-label to kids, the intrusion of for-profit insurance companies into health care delivery has played an equally important role. Even where a child has severe emotional problems, insurance companies refuse to pay for psychiatric visits or hospitalization without a diagnosis of mental illness. Moreover only drug treatment is covered, even if the difficulties result from family problems.

Psychiatric Researchers on the Drug Industry Payroll

Meanwhile child psychiatrists who feel uneasy prescribing dangerous antipsychotic medication to children are cheered on by pre-eminent researchers issuing stern warnings about ruining a child’s future life by “missing” the diagnosis. Unfortunately most of the self-proclaimed pediatric bipolar disorder (PBD) experts neglected to disclose their conflict of interest, in the form of hundreds of thousands of dollars in research grants and consultant fees from drug companies who produce antipsychotics. This has only come out in subsequent lawsuits (see http://www.psychsearch.net/lawsuits.html) and ethical investigations (http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/).

In addition to pressure from insurance companies and PBD experts, child psychiatrists and pediatricians also experience major pressure from parents, owing to massive direct-to-consumer marketing – in the form of dozens of books, magazine articles and TV documentaries promoting PBD as the only explanation for severe behavioral problems – and a magic pill as the easy answer. Many of these parents, convinced by all the media hype, feel justified in demanding doctors prescribe these wonder drugs for their kids. Pity the poor child psychiatrist who stands firm on recommending the appropriate, evidence-based treatment – a lengthy course of family or behavioral treatment that isn’t covered by insurance.

Death and Other Dangerous Complications

The complications of antipsychotic treatment in children fall into four broad categories: death, severe medical complications, social exclusion and delayed emotional development.

1. Death

As Dr Parry points out in his slideshow, fifteen years of FDA adverse incident reports (which typically capture only 1% of adverse drug events) reveal that antipsychotics are directly implicated in the death of scores of children:

2000-2004: 45 deaths (source http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm)

2006: 29 deaths (source http://www.nytimes.com/2007/05/10/health/10psyche.html?pagewanted=1)

2.  Severe Medical Complications

Antipsychotics tend to cause massive weight gain – often as much as 100 pounds – which commonly leads to diabetes. In addition a disfiguring neurological disorder called tardive dyskinesia that occurs in 6-9% of children who take antipsychotics. The tics and writhing movements associated with tardive dyskinesia often persist permanently, even after the medication is stopped.

3. Social exclusion

Labeling a child with a mental illness, particularly if they are taking a medications that cause sedation, extreme weight gain and/or tics has an extremely detrimental effect on their social relationships, which are absolutely vital to normal child development.

4. Delayed emotional development

Sedating a child who has difficulty regulating anger and extreme moods only further delays the process of learning to regulate their emotions themselves.

Do Children with PBD Grow Up Bipolar?

The main argument used for aggressive diagnosis and treatment of PBD is that treating bipolar illness early gives a child a better chance of leading a normal adult life. However now that increasing numbers of children with so-called PBD are in their twenties and thirties, it turns out that the vast majority “outgrow” PBD in adulthood. These results have led some American researchers to reach the same conclusion developmental psychiatrists and psychologists reached a decade ago: that the extreme mood swings being labelled PBD are actually a developmental problem that improves with brain maturation.

http://www.sciencedaily.com/releases/2008/10/081006180654.htm

http://www.sciencedaily.com/releases/2009/09/090929141530.htm

Understanding why foreign psychiatrists are so scandalized by their American colleagues’ cavalier attitude towards pediatric bipolar disorder requires some understanding of the child development model psychiatrist and psychologists use in assessing emotional and behavioral problems. The model is based on the premise that children are a product of their environment. If children with extreme rages and temper outbursts come from a chaotic home where parents are constantly yelling at them, these problems must be recognized as a “developmental” problem, rather than mental illness. In other words, a negative family environment has caused some aspects of the child’s emotional development to be delayed. Diagnosing a child with a mental illness such as bipolar disorder – when the problem really lies with the parents – is called scapegoating and does both the child and the family a great disservice.

This developmental approach theorizes that all babies are born without the ability to regulate anger and other extreme emotions. In infancy and early childhood, parents help children regulate their emotions through soothing and calm limit setting. Via a constant repetition of this process, children eventually learn to regulate extreme emotion on their own. Where a problem commonly develops is when parents themselves have never learned emotional regulation and respond to children’s anger and distress by losing their temper.

In some instances difficulty in regulating emotion can occur for reasons other than inconsistent parenting. The two most common are trauma (physical, emotional and/or sexual abuse) and attachment difficulties (where the child fails to bond adequatelly with the primary caregiver). Physical and emotional abuse may stem from school bullying or an abusive sibling and have nothing to do with poor parenting.

The Dangers of Checklist Diagnosis

In Europe and here in the South Pacific, child psychiatrists argue that to demonstrate the presence of a mental illness such as pediatric bipolar disorder (PBD, the treating psychiatrist must demonstrate (by taking a careful developmental history) that the child previously had the ability to regulate extreme mood swings that was lost when the “illness” developed. Clearly this isn’t being done, as many PBD aficionados, claiming that developmental and school histories are unnecessary, are making the diagnosis based on mood checklists alone. A checklist approach to diagnosis is extremely dangerous in children. The tendency for all children under stress to n to manifest extremes in mood and behavior (as all parents of young children will agree) makes it impossible to define the limits of normal mood and behavior.

What foreign and some American child psychiatrists find particularly horrifying about is the large number of children in the foster care system – who clearly have developmental issues based on abusive and neglectful homes – receiving the diagnosis of PBD and being put on antipsychotics to control anger and behavioral problems. In most cases, this involves a cocktail of three to four drugs because antipsychotics don’t work that well in children (they have little therapeutic effects other than sedation). Typically, in addition to the antipsychotic, kids will be given an anti-seizure medication (used commonly in adult bipolar patients), an antidepressant, lithium, and/or clonidine (a blood pressure medication that calms children by dropping their blood pressure).

To be continued

I have blogged previously (see “Menopause: Made in the USA” http://stuartbramhall.aegauthorblogs.com/2011/03/27/menopause-made-in-the-usa/) about the negative effects of the “corporatization” of health care in the US, particularly the campaign by pharmaceutical companies to “medicalize” common conditions in order to market drugs that supposedly treat them. Thanks to skillful marketing, Eli Lilly has also turned premenstrual syndrome (PMS) into a profit-making commodity nearly as lucrative as “childhood bipolar disorder” (a controversial condition only recognized in the US).

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual “as a possible mental disorder requiring more research.” Although DSM IV lists PMDD as a strictly “research” diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.

The Difference Between PMS and PMDD

Approximately 80-90% of women worldwide report physical and emotional changes in the 7-10 days prior to the onset of menstruation. For the majority of women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating). Approximately 1/3 of women note mental and emotional changes (aka PMS) – depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating – that have a minor impact on their daily functioning. Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women’s health literature that approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a “marked” decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study recently ascertained that the true percentage of women experiencing a “marked” decrease in functioning before their period closer to 1.3% (http://www.nytimes.com/ref/health/healthguide/esn-pms-ess.html)

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce much cheaper generic versions, resulting in plummeting sales of the original brand name drug. Lilly, which was facing the expiration of its patent (in 1999) on Prozac, exploited the inclusion of PMDD in the 1994 DSM IV by re-branding Prozac as a feminine pink and purple tablet called Sarafem. In 2001, the FDA approved Sarafem for “PMDD,” on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).

I found this high response rate really puzzling, given that 30 years of double blind studies using fluoxetine to treat depression have an average response rate of 38-40%. In fact statistical analysis of all randomized controlled reveal that the average response rate of all SSRI antidepressants (i.e. Prozac, Zoloft, Paxil, citalopram, etc) is only slightly higher than the placebo rate (33-37%). In fact as I have blogged previously, there is no scientific evidence that serotonin deficiency (the alleged condition SSRI’s are prescribed for) actually causes depression.

Skillful Marketing: Adding Billions to the US Health Care Bill

Charging $3 per dose for their pink and purple Sarafem tablets (in contrast to 41 cents a pill per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year it came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits. The high number of prescriptions suggests that doctors have been giving it out indiscriminately for premenstrual complaints, rather than limiting treatment to women with the severe symptoms allegedly associated with PMDD. Moreover given the soaring cost of health care in the US (the main reason millions of Americans go without medical care), it seems cynically immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at 1/9 the cost.

After Lilly’s phenomenal success, psychiatrists and drug researchers seized on a handful of studies to claim that serotonin deficiency was the cause of of of both PMDD and PMS. This, in turn, led other SSRI manufacturers to jump on the bandwagon to get similar drugs approved.

To be continued, with research suggesting PMS may be a nutritional deficiency.