Professor Peter Kinderman (BPS) 'PSYCHOLOGY IS CENTRAL TO MENTAL HEALTH SERVICES.' - JUNE 2011

This morning's Guardian has an interview with Professor Dinesh Bhugra, the outgoing president of the Royal College of Psychiatrists. In  it he says that "widespread failures in inpatient care for mentally ill people" mean many hospital wards do not meet acceptable standards, and that people are being discharged back into society when they remain a risk to themselves and others.

Professor Bhugra blames the problem partly on a "dangerous vacuum" created because British doctors are not training as psychiatrists, while visa restrictions mean doctors from abroad can no longer fill the gap.

Responding to the interview, Professor Peter Kinderman, the chair of the British Psychological Society's Division of Clinical Psychology says:

"It is clearly important to maintain - even strengthen - investment in mental health services. People can develop mental health problems for a wide variety of reasons, but we know that social and economic circumstances have an enormous impact on people's mental health. In debt, in times of uncertainly and even fear for the future, when people are unsure of their ability to provide for their children and see their careers crumble, we clearly need to support people's mental health. So it's absolutely true that we need to invest in high-quality mental health services.

"Those services should be high-quality, evidence-based and founded on humanitarian values: fairness, respect, equity and dignity. Traditional psychiatry clearly plays a part in that, but the services needed are much wider than simply a bio-medical approach.

"Our responses to stress, our thoughts, behaviours and emotions - our mental health - are largely dependent on the way we understanding the world, and that, in turn, is largely dependent on our upbringing and the experiences we've had through life. So it's important that a psychological perspective is central to any services."

Peter Kinderman will be appearing on the BBC Radio 4 programme All in the Mind this evening (21 June) to talk about the launch of a pioneering online scientific experiment to test the nation's mental health and well-being.

THIS APPLIES TO THE EARLY STAGES OF DIAGNOSIS AND TREATMENT WITH CHILDREN AS WELL WHERE ACCORDING TO N.I.C.E. PSYCHOLOGICAL APPROACHES SHOULD BE EXPLORED FIRST.

THEY ARE NOT NORMALLY.

  

Daily Mail- How shy children may be diagnosed inappropriately and drugged

Now shy children face risk of being given mental-health drugs... with 650,000 youngsters already on Ritalin

By Emily Allen
    Experts fear widespread use of powerful medications
    Hyperactive children already being treated with drugs


Last updated at 1:30 PM on 15th September 2011

BESTSELLER BOOK BY PROFESSOR CHRISTOPHER LANE

Children who are shy or considered moody run the risk of being diagnosed with mental illnesses and given powerful drugs like Prozac, psychologists have warned.

Experts said mental health diagnoses are likely to increase from 2013 as new guidelines on the definition of mental illness are being drawn up in America and are likely to be replicated in Britain.

Psychologists in the UK fear school-age children could be diagnosed with mental illnesses like 'social anxiety disorder' if they are quieter among their peers, or depression if a child is temporarily sad or is battling bereavement.
Common problems among children such as shyness could be regarded as a mental illness psychologists have warned.

Common problems among children such as shyness could be regarded as a mental illness psychologists have warned

Meanwhile, youngsters who appear to lose their temper easily or answer back to adults could be classed as having 'oppositional defiant disorder'.

Once diagnosed, psychologists say children are likely to be treated with powerful drugs like Prozac or Ritalin to curb their behaviour - without fully understanding the long-term impacts.

Ritalin is already used to help control attention deficit hyperactivity disorder in youngsters under six and about 650,000 children aged between eight and 13 have also been prescribed the drug or an equivalent.
 

MENTAL ILLNESS OR COMMON PROBLEM?
Common problems among children such as shyness could be regarded as a mental illness psychologists have warned.

Social anxiety disorder: Where someone is fearful or anxious about social situations where they might be exposed to scrutiny by others.

They might be fearful of situations including having a conversation, being watched, or performing in front of other people.

Youngsters may react by clinging on to adults, crying, or refusing to speak in social situations.

Oppositional defiant disorder: If youngsters lose their tempter or argue with adults or are 'spiteful or vindictive at least twice within six months to others' - not their siblings.

Earlier this week, the TUC called for an investigation into the use of mental health drugs among school-age children and voted to see more research into their long-term impacts.

Kate Fallon, general secretary of the Association of Educational Psychologists, told The Daily Telegraph: 'Behaviours develop over a long period of time, often with a range of complex causes; we can’t "cure" the behaviours we don’t like with a quick fix of medicine.

'They usually require careful management by all the adults around the child.'

She said parents need to take time and energy to help their children deal with their problems and warned it was tempting to opt for a drug which would be quick to change their behaviour.

The British Psychological Society is also concerned about the new guidelines and said pigeon-holing problems as 'illnesses' ignores the wider causes

Read more: http://www.dailymail.co.uk/health/article-2037610/Children-pumped-powerful-drugs-combat-shyness-psychologists-warn.html#ixzz1Y3LhJuPj

ANTIDEPRESSANTS ON THE RISE

Advertising is behind the high take-up of antidepressants
Subtle advertising has led doctors to prescribe more antidepressants.
Mothers are twice as likely to suffer from depression than they did 40 years ago - Advertising is behind the high take-up of antidepressants
Mothers are twice as likely to suffer from depression than they did 40 years ago
By James LeFanu

7:30AM BST 12 Sep 2011

ANTIDEPRESSANTS

The pressures on many mothers juggling the demands of work and family are no doubt stressful enough. Still, it is hard to credit the report last week from the authoritative-sounding European College of Neuropsychopharmacology that, as a result, they are twice as likely to suffer from depression than 40 years ago.

It is certainly true that, astonishingly, family doctors now write three times more prescriptions for antidepressants than back in the Seventies, but that mainly reflects the success of drug companies in redefining psychological and other conditions in such a way as to encourage doctors to treat those conditions with pills.

Their methods were well reported by a New York advertising executive, Vince Parry, in a 2003 article, “The Art of Branding a Condition”, in which he described how he collaborated with several companies to foster “the creation of medical disorders”, by deploying three main strategies.

First, elevate the importance of symptoms, then redefine an existing condition, before developing “a new condition for an unmet market need”.

The several instances of this brand conditioning include “medicalising” normal physical events, redefining psychological traits as quasi-psychiatric illnesses (so shyness becomes social phobia) and, most important, redefining the limits of what is considered normal of some physiological variable such as blood pressure or cholesterol.

The process itself has to be subtle, almost subliminal, a carefully orchestrated campaign to shift perceptions involving the co-operation of prominent doctors (or, as they are known in the industry, key opinion leaders). And very effective it has proved to be, with pharmaceutical industry sales during this period doubling from $400 (£250) billion to $800 (£500) billion a year.

TUC CONGRESS MOTION FROM AEP IN TELEGRAPH ONLINE 15-9-11 -'SHY' KIDS MAY BE INCREASINGLY MEDICATED AFTER DSM5 IS RELEASED - BROADENING DIAGNOSTIC CRITERIA COULD OPEN FLOODGATES TO OVER-PRESCRIPTION OF POTENTIALLY HARMFUL DRUGS FOR CHILDREN IN THE U.K.

'SHY','SAD' AND 'BOLSHY' KIDS MAY END UP ON LEGAL DRUGS

Children who are merely shy or sad are at risk of  mental disorders 'label' and be given powerful drugs, experts warn.

By Martin Beckford, Health Correspondent Telegraph online
CLICK ON TITLE FOR LINK

10:00PM BST 14 Sep 2011


Psychologists say that new guidelines being developed in America will lead more young people seeing their common problems regarded as illnesses that must be treated, rather than just being given support.

They fear that pupils who are quiet at school could be diagnosed with “social anxiety disorder” while those who become withdrawn after suffering a bereavement are classified as having a “depressive disorder”.

Children who just talk back to adults or lose their temper regularly could be diagnosed with “oppositional defiant disorder”.

As a result, those found to have these increasingly broad mental disorders could be prescribed powerful medication such as Prozac or Ritalin to control or alter their behaviour.

Now the pressure is increasing for a national review of the use of such drugs on schoolchildren as well as more research into their long-term effects, following a vote at the TUC Congress on Wednesday.

Kate Fallon, general secretary of the Association of Educational Psychologists, told delegates: “Behaviours develop over a long period of time, often with a range of complex causes; we can’t ‘cure’ the behaviours we don’t like with a quick fix of medicine. They usually require careful management by all the adults around the child.

“In 2013 we’re expecting new criteria for the definition of mental illness to be adopted here in the UK. These criteria will lead to many more children being diagnosed as mentally ill, based on reports of their behaviours.

“A shy child could be diagnosed with social anxiety; a sad or temporarily withdrawn child could be diagnosed with depression.

“These are conditions which are also likely to be treated with medication – and under these circumstances, Congress, we will be putting potent drugs into children with little or no understanding of what it will lead to.

“In a society that wants quick results using drugs to improve behaviour is very tempting. But there can be other ways of improving children’s behaviour which typically involve time and energy from people.”

Research has found that children under the age of six are being prescribed the drug Ritalin for attention deficit hyperactivity disorder, prompting calls for the Department of Health to investigate the scale of the problem and the potential long-term damage it may be causing.

Recent figures show 650,000 children aged between eight and 13 are on the pscyhotropic drug, up from just 9,000 two decades ago, while others are taking Prozac for depression or anxiety.

Fears are growing that the number of children diagnosed with mental disorders and prescribed drugs will increase still further after 2013, when a new “bible” of the psychiatric profession is published.

Known as DSM-5, the book widens the diagnostic criteria for many supposed conditions including social anxiety disorder, better known as shyness, and will likely be adopted by the health authorities in Britain after appearing first in the US.

The proposed new definition for social anxiety disorder states that it is marked by “fear or anxiety about one or more social situations in which the person is exposed to possible scrutiny by others. Examples include social interactions (e.g., having a conversation), being observed (e.g., eating or drinking), or performing in front of others (e.g., giving a speech)”.

In children this fear could be expressed by “crying, tantrums, freezing, clinging, shrinking or refusal to speak in social situations”.

Young people will be deemed as having oppositional defiant disorder if they display symptoms including losing their temper, arguing with adults, deliberately annoying people or being “spiteful or vindictive at least twice within the past six months” to people other than their brothers or sisters.

The British Psychological Society has also raised concerns about the proposed revisions to the DSM.

It does not dispute that some children have emotional and behavioural problems but says that patients and the public are “negatively affected” by the continued “medicalisation” of natural and normal responses to their experiences, and that classifying such problems as “illnesses” ignores their wider causes.

Prof Peter Kinderman, chairman of the society’s Division of Clinical Psychology, said: “We’re not certain that a diagnosis and a medical response is the best way to help these kids.

“Absolutely understand and help, not necessarily diagnose and treat.”

NIDA- trends in prescription drug abuse- 2003 - amphetamines have now become the most abused prescription and illegal drug by young people in the U.S.- is there a link? - contains descriptions of the harmful effects of the three main categories of abused prescription drugs.

Trends in prescription drug abuse
 
Graph: Past month use of selected illicit drugs among youths, by age: 2003

Although prescription drug abuse affects many Americans, some concerning trends can be seen among older adults, adolescents, and women. Several indicators suggest that prescription drug abuse is on the rise in the United States. According to the 2003 National Survey on Drug Use and Health (NSDUH), an estimated 4.7 million Americans used prescription drugs nonmedically for the first time in 2002 -

    2.5 million used pain relievers
    1.2 million used tranquilizers
    761,000 used stimulants
    225,000 used sedatives

Pain reliever incidence increased-from 573,000 initiates in 1990 to 2.5 million initiates in 2000-and has remained stable through 2003. In 2002, more than half (55 percent) of the new users were females, and more than half (56 percent) were ages 18 or older.

The Drug Abuse Warning Network (DAWN), which monitors medications and illicit drugs reported in emergency departments (EDs) across the Nation, recently found that two of the most frequently reported prescription medications in drug abuse-related cases are benzodiazepines (e.g., diazepam, alprazolam, clonazepam, and lorazepam) and opioid pain relievers (e.g., oxycodone, hydrocodone, morphine, methadone, and combinations that include these drugs). In 2002, benzodiazepines accounted for 100,784 mentions that were classified as drug abuse cases, and opioid pain relievers accounted for more than 119,000 ED mentions. From 1994 to 2002, ED mentions of hydrocodone and oxycodone increased by 170 percent and 450 percent, respectively. While ED visits attributed to drug addiction and drug-taking for psychoactive effects have been increasing, intentional overdose visits have remained stable since 1995.

Older adults

Persons 65 years of age and above comprise only 13 percent of the population, yet account for approximately one-third of all medications prescribed in the United States. Older patients are more likely to be prescribed long-term and multiple prescriptions, which could lead to unintentional misuse.

The elderly also are at risk for prescription drug abuse, in which they intentionally take medications that are not medically necessary. In addition to prescription medications, a large percentage of older adults also use OTC medicines and dietary supplements. Because of their high rates of comorbid illnesses, changes in drug metabolism with age, and the potential for drug interactions, prescription and OTC drug abuse and misuse can have more adverse health consequences among the elderly than are likely to be seen in a younger population. Elderly persons who take benzodiazepines are at increased risk for cognitive impairment associated with benzodiazepine use, leading to possible falls (causing hip and thigh fractures), as well as vehicle accidents. However, cognitive impairment may be reversible once the drug is discontinued.

Graph: Past-year use of other drugs reported by prescription drug abusers: Persons aged 12-25, 2001

Adolescents and young adults

Data from the 2003 NSDUH indicate that 4.0 percent of youth ages 12 to 17 reported nonmedical use of prescription medications in the past month. Rates of abuse were highest among the 18-25 age group (6.0 percent). Among the youngest group surveyed, ages 12-13, a higher percentage reported using psychotherapeutics (1.8 percent) than marijuana (1.0 percent).

The NIDA Monitoring the Future survey of 8th-, 10th-, and 12th-graders found that the nonmedical use of opioids, tranquilizers, sedatives/barbiturates, and amphetamines was unchanged between 2003 and 2004. Specifically, the survey found that 5.0 percent of 12th-graders reported using OxyContin without a prescription in the past year, and 9.3 percent reported using Vicodin, making Vicodin one of the most commonly abused licit drugs in this population. Past year, nonmedical use of tranquilizers (e.g., Valium, Xanax) in 2004 was 2.5 percent for 8th-graders, 5.1 percent for 10th-graders, and 7.3 percent for 12th-graders. Also within the past year, 6.5 percent of 12th-graders used sedatives/ barbiturates (e.g., Amytal, Nembutal) nonmedically, and 10.0 percent used amphetamines (e.g., Ritalin, Benzedrine).

Youth who use other drugs are more likely to abuse prescription medications. According to the 2001 National Household Survey on Drug Abuse (now the NSDUH), 63 percent of youth who had used prescription drugs nonmedically in the past year had also used marijuana in the past year, compared with 17 percent of youth who had not used prescription drugs nonmedically in the past year.

Gender differences

Studies suggest that women are more likely than men to be prescribed an abusable prescription drug, particularly narcotics and antianxiety drugs—in some cases, 55 percent more likely.

Overall, men and women have roughly similar rates of nonmedical use of prescription drugs. An exception is found among 12- to 17-year-olds. In this age group, young women are more likely than young men to use psychotherapeutic drugs nonmedically. In addition, research has shown that women are at increased risk for nonmedical use of narcotic analgesics and tranquilizers (e.g., benzodiazepines).

NIDA InfoFacts: Prescription and Over-the-Counter Medications


Prescription medications such as pain relievers, central nervous system (CNS) depressants (tranquilizers and sedatives), and stimulants are highly beneficial treatments for a variety of health conditions. Pain relievers enable individuals with chronic pain to lead productive lives; tranquilizers can reduce anxiety and help patients with sleep disorders; and stimulants help people with attention-deficit hyperactivity disorder (ADHD) focus their attention. Most people who take prescription medications use them responsibly. But when abused—that is, taken by someone other than the patient for whom the medication was prescribed, or taken in a manner or dosage other than what was prescribed—prescription medications can produce serious adverse health effects, including addiction.

Patients, health care professionals, and pharmacists all have roles in preventing the abuse1 of and addiction to prescription medications. For example, patients should follow the directions for use carefully; learn what effects and side effects the medication could have; and inform their doctor/pharmacist whether they are taking other medications [including over-the-counter (OTC) medications or health supplements], since these could potentially interact with the prescribed medication. The patient should read all information provided by the pharmacist. Physicians and other health care providers should screen for past or current substance abuse in the patient during routine examination, including asking questions about what other medications the patient is taking and why. Providers should note any rapid increases in the amount of a medication needed or frequent requests for refills before the quantity prescribed should have been finished, as these may be indicators of abuse.1

Similarly, some OTC medications, such as cough and cold medicines containing dextromethorphan, have beneficial effects when taken as recommended; but they can also be abused and lead to serious adverse health consequences. Parents should be aware of the potential for abuse of these medications, especially when consumed in large quantities, which should signal concern and the possible need for intervention.
Commonly Abused Prescription Medications

Although many prescription medications can be abused, the following three classes are most commonly abused:

    Opioids—usually prescribed to treat pain.
    CNS depressants—used to treat anxiety and sleep disorders.
    Stimulants—prescribed to treat ADHD and narcolepsy.e.g amphetamines and amphetamine like drugs.

Opioids

What Are Opioids?
Opioids are analgesic, or pain-relieving, medications. Studies have shown that properly managed medical use (taken exactly as prescribed) of opioid analgesics is safe, can manage pain effectively, and rarely causes addiction.

Among the compounds that fall within this class are hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin—an oral, controlled-release form of the drug), morphine, fentanyl, codeine, and related medications. Morphine and fentanyl are often used to alleviate severe pain, while codeine is used for milder pain. Other examples of opioids prescribed to relieve pain include propoxyphene (Darvon); hydromorphone (Dilaudid); and meperidine (Demerol), which is used less often because of its side effects. In addition to their effective pain-relieving properties, some of these medications can be used to relieve severe diarrhea (for example, Lomotil, also known as diphenoxylate) or severe coughs (codeine).

How Are Opioids Abused?
Opioids can be taken orally, or the pills may be crushed and the powder snorted or injected. A number of overdose deaths have resulted from the latter routes of administration, particularly with the drug OxyContin, which was designed to be a slow-release formulation. Snorting or injecting opioids results in the rapid release of the drug into the bloodstream, exposing the person to high doses and causing many of the reported overdose reactions.

How Do Opioids Affect the Brain?
Opioids act by attaching to specific proteins called opioid receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these compounds attach to certain opioid receptors in the brain and spinal cord, they can effectively change the way a person experiences pain.

In addition, opioid medications can affect regions of the brain that mediate what one perceives as pleasure, resulting in the initial euphoria or sense of well-being that many opioids produce. Repeated abuse of opioids can lead to addiction—a chronic, relapsing disease characterized by compulsive drug seeking and abuse despite its known harmful consequences.
What Adverse Effects Can Be Associated With Opioids?

Opioids can produce drowsiness, cause constipation, and, depending upon the amount taken, depress breathing. Taking a large single dose could cause severe respiratory depression or death.

These medications are only safe to use with other substances under a physician’s supervision. Typically, they should not be used with alcohol, antihistamines, barbiturates, or benzodiazepines. Because these other substances slow breathing, their effects in combination with opioids could lead to life-threatening respiratory depression.
 
What Happens When You Stop Taking Opioids?

Patients who are prescribed opioids for a period of time may develop a physical dependence on them, which is not the same as addiction. Repeated exposure to opioids causes the body to adapt, sometimes resulting in tolerance (that is, more of the drug is needed to achieve the desired effect compared with when it was first prescribed) and in withdrawal symptoms upon abrupt cessation of drug use. Thus, individuals taking prescribed opioid medications should not only be given these medications under appropriate medical supervision, but they should also be medically supervised when stopping use in order to reduce or avoid withdrawal symptoms. Symptoms of withdrawal can include restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps (“cold turkey”), and involuntary leg movements.
Are There Treatments for Opioid Addiction?

Individuals who abuse or are addicted to prescription opioid medications can be treated. Initially, they may need to undergo medically supervised detoxification to help reduce withdrawal symptoms; however, that is just the first step. Options for effectively treating addiction to prescription opioids are drawn from research on treating heroin addiction. Behavioral treatments, usually combined with medications, have also been proven effective. Currently used medications are—

    Methadone, a synthetic opioid that eliminates withdrawal symptoms and relieves craving, has been used successfully for more than 30 years to treat people addicted to heroin as well as opiates.
    Buprenorphine, another synthetic opioid, is a more recently approved medication for treating addiction to heroin and other opiates. It can be prescribed in a physician’s office.
    Naltrexone is a long-acting opioid receptor blocker that can be employed to help prevent relapse. It is not widely used, however, because of poor compliance, except by highly motivated individuals (e.g., physicians at risk of losing their medical license). It should be noted that this medication can only be used for someone who has already been detoxified, since it can produce severe withdrawal symptoms in a person continuing to abuse opioids.
    Naloxone is a short-acting opioid receptor blocker that counteracts the effects of opioids and can be used to treat overdoses.

CNS Depressants

What Are CNS Depressants?
CNS depressants (e.g., tranquilizers, sedatives) are medications that slow normal brain function. In higher doses, some CNS depressants can be used as general anesthetics or preanesthetics.

CNS depressants can be divided into three groups, based on their chemistry and pharmacology:

    Barbiturates, such as mephobarbital (Mebaral) and sodium pentobarbital (Nembutal), are used as preanesthetics, promoting sleep.
    Benzodiazepines, such as diazepam (Valium), alprazolam (Xanax), and estazolam (ProSom), can be prescribed to treat anxiety, acute stress reactions, panic attacks, convulsions, and sleep disorders. For the latter, benzodiazepines are usually prescribed only for short-term relief of sleep problems because of the development of tolerance and risk of addiction.
    Newer sleep medications, such as zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta), are now more commonly prescribed to treat sleep disorders. These medications are nonbenzodiazepines that act at a subset of the benzodiazepine receptors and appear to have a lower risk for abuse and addiction.

How Are CNS Depressants Abused?
CNS depressants are usually taken orally, sometimes in combination with other drugs or to counteract the effects of other licit or illicit drugs (e.g., stimulants).

How Do CNS Depressants Affect the Brain?
Most of the CNS depressants have similar actions in the brain: they enhance the actions of the neurotransmitter gamma-aminobutyric acid (GABA)—neurotransmitters are brain chemicals that facilitate communication between brain cells. GABA works by decreasing brain activity. Although different classes of CNS depressants work in unique ways, it is ultimately their common ability to increase GABA activity that produces a drowsy or calming effect.

What Adverse Effects Can Be Associated With CNS Depressants?
Despite their beneficial effects for people suffering from anxiety or sleep disorders, barbiturates and benzodiazepines can be addictive and should be used only as prescribed.

CNS depressants should not be combined with any medication or substance that causes drowsiness, including prescription pain medicines, certain OTC cold and allergy medications, and alcohol. If combined, they can slow both heart rate and respiration, which can be fatal.

What Happens When You Stop Taking CNS Depressants?
Discontinuing prolonged use or abuse of high doses of CNS depressants can lead to serious withdrawal symptoms. Because the drug works by slowing the brain’s activity, when one stops taking a CNS depressant, this activity can rebound to the point that seizures can occur. Someone who is either thinking about ending use of a CNS depressant, or who has stopped and is suffering withdrawal should seek medical treatment.

Are There Treatments for Addiction to CNS Depressants?
In addition to medical supervision during withdrawal, counseling in an inpatient or outpatient setting can help people who are overcoming addiction to CNS depressants. For example, cognitive-behavioral therapy has been used successfully to help individuals in treatment for abuse of benzodiazepines. This type of therapy focuses on modifying a patient’s thinking, expectations, and behaviors while simultaneously increasing his or her skills for coping with various life stressors.
Stimulants

What Are Stimulants?
Stimulants (amphetamines [Adderall, Dexedrine] and methylphenidate [Concerta, Ritalin]) increase alertness, attention, and energy. They also increase blood pressure and heart rate, constrict blood vessels, increase blood glucose, and open up the pathways of the respiratory system. Historically, stimulants were prescribed to treat asthma and other respiratory problems, obesity, neurological disorders, and a variety of other ailments. As their potential for abuse and addiction became apparent, the prescribing of stimulants by physicians began to wane. Now, stimulants are prescribed for treating only a few health conditions, most notably ADHD, narcolepsy, and, in some instances, depression that has not responded to other treatments.

How Are Stimulants Abused?
Stimulants may be taken orally, but some abusers crush the tablets, dissolve them in water, and then inject the mixture; complications can arise from this because insoluble fillers in the tablets can block small blood vessels. Stimulants have been abused for both “performance enhancement” and recreational purposes (i.e., to get high).

How Do Prescription Stimulants Affect the Brain?
Stimulants have chemical structures that are similar to key brain neurotransmitters called monoamines, including dopamine and norepinephrine. Their therapeutic effect is achieved by slow and steady increases of dopamine that are similar to the natural production of this chemical by the brain. The doses prescribed by physicians start low and increase gradually until a therapeutic effect is reached. However, when taken in doses and routes other than those prescribed, stimulants can increase the brain’s dopamine levels in a rapid and highly amplified manner—as do most other drugs of abuse—disrupting normal communication between brain cells, producing euphoria, and increasing the risk of addiction.

What Adverse Effects Are Associated With Stimulant Abuse?
Taking high doses of a stimulant can result in an irregular heartbeat, dangerously high body temperatures, and/or the potential for cardiovascular failure or seizures. Taking some stimulants in high doses or repeatedly can lead to hostility or feelings of paranoia in some individuals.

Stimulants should not be mixed with antidepressants, which may enhance the effects of a stimulant; or with OTC cold medicines containing decongestants, which may cause blood pressure to become dangerously high or may lead to irregular heart rhythms.

Are There Treatments for Stimulant Addiction?
Treatment of addiction to prescription stimulants is based on behavioral therapies proven effective for treating cocaine or methamphetamine addiction. At this time, there are no proven medications for the treatment of stimulant addiction.

Depending on the patient’s situation, the first step in treating prescription stimulant addiction may be to decrease the drug’s dose slowly and attempt to treat withdrawal symptoms (mood changes, sleep and appetite disturbances). This process of detoxification could then be followed with one of many behavioral therapies: contingency management, for example, improves treatment outcomes by enabling patients to earn vouchers for drug-free urine tests; the vouchers can be exchanged for items that promote healthy living. Cognitive-behavioral therapies—which teach patients skills to recognize risky situations, avoid drug use, and cope more effectively with problems—are proving beneficial. Recovery support groups may also be effective in conjunction with a behavioral therapy.
Dextromethorphan (DXM)

What Is DXM?
DXM is the active ingredient found in OTC cough and cold medications. When taken in recommended doses, these medications are safe and effective.

How Is DXM Abused?
DXM is taken orally. In order to experience the mind-altering effects of DXM, excessive amounts of liquid or gelcaps must be consumed. The availability and accessibility of these products make them a serious concern, particularly for youth, who tend to be their primary abusers.

What Are the Consequences Associated With the Abuse of DXM?
In very large quantities, DXM can cause effects similar to those of ketamine and PCP because these drugs affect similar sites in the brain. These effects can include impaired motor function, numbness, nausea/vomiting, and increased heart rate and blood pressure. On rare occasions, hypoxic brain damage—caused by severe respiratory depression and a lack of oxygen to the brain—has occurred due to the combination of DXM with decongestants often found in the medication.
 
What Are the Trends in the Abuse of Prescription Drugs and OTC Medications?

Monitoring the Future (MTF) Survey2
Each year, the Monitoring the Future (MTF) survey assesses the extent of drug use among 8th-, 10th-, and 12th-graders nationwide. Nonmedical use of any prescription drug is reported only for 12th-graders, and in 2008, 15.4 percent reported past-year use. Prescription and OTC medications were the most commonly abused drugs by high school students after marijuana. In addition, they represent 6 of the top 10 illicit drugs reported by 12th-graders.

Prescription Painkillers. In 2002, MTF added questions to the survey about past-year nonmedical use of Vicodin and OxyContin. For Vicodin, past-year nonmedical use has remained stable at high levels for each grade since its inclusion in the survey.
Rate of Past-Year Use in 2008
Drug Name      8th-Grade      10th-Grade      12th-Grade
Vicodin     2.9%     6.7%     9.7%
OxyContin     2.1%     3.6%     4.7%

CNS Depressants. Nonmedical use of tranquilizers (benzodiazepines and others) by 10th-grade students decreased between 2001 and 2008 for all prevalence periods (lifetime,3 past-year, and past-month use). Use of sedatives (barbiturates), for which data are collected only from 12th-graders, has remained steady.
Rate of Past-Year Use in 2008
Drug Name      8th-Grade      10th-Grade      12th-Grade
Tranquilizers     2.4%     4.6%     6.2%
Sedatives     --     --     5.8%

Stimulants. Nonmedical use of stimulants is broken up by the type of stimulant used: amphetamines, methamphetamine, or Ritalin. For all three stimulants surveyed, rates have decreased significantly among 8th-, 10th-, and 12th-graders in 2001–2008.
Rate of Past-Year Use in 2008
Drug Name      8th-Grade      10th-Grade      12th-Grade
Amphetamines     4.5%     6.4%     6.8%
Methamphetamine     1.2%     1.5%     1.2%
Ritalin     1.6%     2.9%     3.4%

Cough Medicine. In 2006, a question about the use of cough and cold medicines to get high was asked for the first time.
Rate of Past-Year Use in 2008
Drug Name      8th-Grade      10th-Grade      12th-Grade
Cough Medicine     3.6%     5.3%     5.5%

National Survey on Drug Use and Health (NSDUH)4
According to the 2007 NSDUH, an estimated 6.9 million persons, or 2.8 percent of the population, aged 12 or older had used prescription psychotherapeutic medications nonmedically in the month prior to being surveyed. This includes 5.2 million using pain relievers (an increase from 4.7 million in 2005), 1.8 million using tranquilizers, 1.1 million using stimulants, and 350,000 using sedatives.

Past-month nonmedical use of prescription-type drugs among young adults aged 18 to 25 increased from 5.5 percent in 2002 to 6 percent in 2007. This was primarily due to an increase in pain reliever use, which was 4.1 percent in 2002 and 4.6 percent in 2007. However, nonmedical use of tranquilizers remained the same over the 6-year period.

Among persons aged 12 or older who used pain relievers nonmedically in the past 12 months, 56.5 percent reported that they got the drug most recently used from someone they knew and that they did not pay for it. Another 18.1 percent reported that they obtained the drug from one doctor. Only 4.1 percent purchased the pain reliever from a drug dealer or other stranger, and just 0.5 percent reported buying the drug on the Internet. Among those who reported getting the pain reliever from a friend or relative for free, 81 percent reported in a followup question that the friend or relative had obtained the drug from one doctor only.
Other Information Sources
For more information on addiction to prescription medications, visit http://www.drugabuse.gov/drugpages/prescription.html.


1 A common vocabulary has not been established in the field of prescription drug abuse. Because much of the survey data collected in this area refer to nonmedical use of prescription drugs, this definition of “abuse,” rather than that of the Diagnostic and Statistical Manual of Mental Disorders (DSM), is used. Also, because physical dependence to prescription medications can develop during medically supervised appropriate use, the term “addiction” is used to reflect dependence as defined by the DSM.

2 These data are from the 2008 Monitoring the Future survey, funded by the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, and conducted annually by the University of Michigan’s Institute for Social Research. The survey has tracked 12th-graders’ illicit drug use and related attitudes since 1975; in 1991, 8th- and 10th-graders were added to the study. The latest data are online at www.drugabuse.gov.

3 “Lifetime” refers to use at least once during a respondent’s lifetime. “Past year” refers to use at least once during the year preceding an individual’s response to the survey. “Past month” refers to use at least once during the 30 days preceding an individual’s response to the survey.

4 NSDUH (formerly known as the National Household Survey on Drug Abuse) is an annual survey of Americans age 12 and older conducted by the Substance Abuse and Mental Health Services Administration.
Copies of the latest survey are available at www.samhsa.gov and from NIDA at 877-643-2644.

MARCIA ANGELL -'THE OTHER DRUG WAR.' - SENIOR LECTURER IN SOCIAL MEDECINE AT HARVARD UNIVERSITY

After a period where health care costs flattened, they're going up sharply. Why is the pharmaceutical sector [of health care costs] rising the fastest?

There are a couple of reasons. One [is] price inflation. The price for the top-selling drugs now averages about $100 for a month's prescription of that drug. It's well over $1,000 a year. The price per drug is increasing about three times the rate of inflation. So one is just prices.
The United States is the only advanced country that permits the pharmaceutical industry to charge exactly what the market will bear.

The other is, through advertising and PR and marketing, consumers are being switched or preferentially led to take newly patented high-price drugs rather than generic drugs that might be just as effective. So the kinds of drugs that are being used are the high-priced drugs.

Third is just the increased volume of use. More people are taking more drugs. This too is a part of promotion and marketing. For all of life's discontents, according to the pharmaceutical industry, there is a drug and you should take it. Then for the side effects of that drug, then there's another drug, and so on. So we're all taking more drugs, and more expensive drugs.

Who's most affected by this price inflation and increased drug costs?

The sick and the helpless are those who are most affected by this price inflation. That is, if you have good insurance that would pay for a prescription drug benefit -- and fewer and fewer of us do have such insurance -- but if you do have that insurance, the HMO through which you have the insurance will bargain for price discounts from the drug companies, get them somewhat cheaper -- in fact, a lot cheaper. You will have to pay less in out-of-pocket contributions.

But for those who are not well insured for prescription drug costs, they're pretty much left on their own. These are mainly Medicare recipients who have no supplementary insurance. Medicare, through historical accident, really, does not pay for outpatient prescription drugs. So Medicare recipients have to pay out of pocket, unless they have supplemental insurance.

Not only do they have to pay out of pocket, but they're likely to be taking more drugs. So if you just look at the price of one of the top selling drugs -- $1200 per year -- and you look at older patients and seniors, who may be taking five or six of these drugs, you can see that they're up to many thousands a year. These are the most vulnerable people. They pay twice as much for drugs, on average, as will insured younger people who get their drugs through HMOs.

People who are covered have no idea what drugs actually cost. Seniors are one of the few groups who actually know the market price.

That's right. They're the ones who are complaining the loudest, and they should. The rest of us are still, to some extent, cushioned from the realities of this incredible price gouging that's going on by the pharmaceutical industry. We're still cushioned to some extent, but that is going to be less and less. We're going to see our insurers paying just a defined contribution, and we will have to make up the rest, or dropping prescription drug benefits altogether. So we too will find out about this very shortly.
  
  

Some seniors in border states notice that drugs are cheaper in Canada, and they actually go and get them. What does that tell us about the two systems?

Well, the United States is the only advanced country that permits the pharmaceutical industry to charge exactly what the market will bear, whatever it wants. The other advanced countries in Europe and Canada have some form of price control, either mandatory volume discounts or some way of limiting price. So on average, Canada spends half of what we spend for the exact same drugs. Half.

So if you live on a border state and you can make a bus trip to Canada and have a prescription, you can -- particularly if you're a senior citizen who has to pay for drugs out of pocket, and have to take a lot of them -- you can do very well by taking that bus trip to Canada.

One argument [is that] he Canadians don't invent the drugs. They're parasitic on our R&D. It's unfair.

In fact, the pharmaceutical industry is what's parasitic on publicly funded research. The pharmaceutical industry likes to depict itself as a research-based industry, as the source of innovative drugs. Nothing could be further from the truth. This is their incredible PR and their nerve.

In fact, if you look at where the original research comes from on which new drugs are based, it tends to be from the NIH [National Institutes of Health], from the academic medical centers, and from foreign academic medical centers. Studies of this, looking at the seminal research on which drug patents are based, have found that about 15 percent of the basic research papers, reporting the basic research, came from industry. That's just 15 percent.

The other 85 percent came from NIH-supported work carried out in American academic medical centers. In one study, 30 percent came from foreign academic medical centers. So what we know about the numbers indicates that the foreign academic medical centers are responsible for more new drug discoveries than the industry itself.

[What is] the profitability of this industry, compared to other American industries?

Numero uno. The pharmaceutical industry is stunningly, staggeringly profitable. The 10 drug companies on the Fortune 500 list last year took in net profits of 18.5 percent on sales. That's 18.5 percent. That is stunning. The median for the other industries on the Fortune 500 list was a little over 3 percent, 3.3 percent of sales. This has been the case for the last 20 years; this is not just a fluke of last year. Year after year after year, the pharmaceutical industry has led all other industries in profits. ...

The drug companies make the case that their prices are so high, and that total expenditures are so high, because their R&D costs are very high, as though they were just eking out, just barely managing to survive. But what we can see is that their profits are very much higher than their R&D costs, and therefore they could spend more on R&D if they wanted, and still have plenty of profits left over.

They are numero uno in R&D as well, aren't they?

Their R&D costs are very high, in absolute terms. But in relative terms, they're quite small, that is, relative to their other expenditures and to their profits. The drug companies spend on average, by their own figures, last year, 15 percent to 17 percent on R&D. That's a lot of money. There's no question that that's a lot of money. But their profits are higher. Their profits are 18.5 percent. That's higher than their R&D.

What's really interesting is what they spend on marketing and administration, by their own figures, on average 35 percent. That's over twice as much as what they spend on R&D. So if they point to their R&D costs as some sort of justification for the high prices, what on earth can they say about their marketing costs, which are over twice that much?

Marketing and administration?

Marketing and administration, yes. One of the problems with talking about the R&D cost and the marketing cost and the profits, and the way the pharmaceutical industry does business, is that they're very secretive about the details. You can't get at exactly what the details are. But you can get close enough. You can infer from certain things.

The major drug companies, in general, combine marketing with administrative costs. So in their annual reports and in their SEC filings, they will give total expenditures for something they call "marketing administration." The indications are that the lion's share of that is for marketing. One company, one of the major companies, does break it down, does separate out marketing from administration. That company attributes 35 percent to marketing, 6 percent to administration.

If you then also look at how the employees are apportioned, by their own figures, over a third of their employees are in marketing -- not marketing administration, but marketing. So I think it's safe to conclude that somewhere on the order of 30 percent -- over twice the R&D costs -- are marketing.

Your contention is this slightly skewed picture is partly responsible for the lack of truly innovative drugs that we've seen lately, and the proliferation of "me too" drugs?

... The drug companies have found that the best way to make money at low cost is by turning out drugs that are imitations of other companies' blockbusters. A blockbuster is commonly accepted to be a drug that sells more than a billion dollars in a year. So they've found that the best way to make money is by imitating other companies' blockbusters, or by imitating their own blockbusters -- making a new version of their own blockbuster, when the first one is going off patent and they want to have one with a longer patent life. That's what they have been turning all of their efforts to now.

Innovation comes mainly from NIH-supported research in academic medical centers. The drug companies do almost no innovation now. It's just turning out one more drug that's similar to a blockbuster. These are called copycat drugs, or "me too" drugs. That's their major business now.

It's very hard to launch a "me too" or copycat drug, because you have to convince doctors and the public that they are somehow different and better from all of the other copycat drugs already on the market. So that's why their marketing costs have to be so high. ...

To get a "me too" past the FDA doesn't require that they prove it better than something on the market?

By law, a drug company cannot market drugs unless those drugs are approved by the FDA. The FDA approves the drugs if the manufacturers have shown, through clinical trials, that they're reasonably safe and effective. But here's the catch: To show that drugs are effective, the manufacturers only have to compare them, usually, with a placebo -- that is, with a sugar pill. So all they're required to do is show that this new drug is better than nothing. They are not required to show that it's better than other drugs already on the market for the same condition.

That's why there are so many "me too" drugs on the market. There's no comparison with older drugs. There's no comparison with generic drugs. The last thing the companies want to do is have a head-to-head comparison with similar drugs already on the market.

If theirs was better, they would want one, wouldn't they?

How will they know that it's better until they test it? Then they take the real risk that it will turn out to be worse. So what we have now is a blizzard of "me too" drugs, copycat drugs, that may be worse than the drugs already on the market, that may actually be worse than generics. There's no reason to think that they're better, and they could be worse. They could have more side effects. There is no way to know that, because the FDA does not require that a new copycat drug be compared with the older drug already on the market.

So they use this marketing budget to try and--

That's right. If the drug company produced a cure for AIDS or a cure for cancer, you wouldn't need a big marketing budget. The world would beat a path to its door. You have to have a huge marketing budget to convince the public that Nexium is better than Prilosec. That takes a great marketing budget. So that's where these marketing expenditures are going.

Now, the FDA itself categorizes the drugs that it reviews as either likely to be an improvement over drugs already on the market -- and they get what's called a priority review -- or as unlikely to be an improvement over whatever is already on the market -- that is, it's likely to be no better than what's already out there.

The number that are categorized as "likely to be an improvement" by the FDA has been going down and down and down. Last year, 2001, only 66 drugs were newly approved. Only 66 out of this whole gigantic industry, and that too has been going down. And of those 66, only 10 were classified as likely to be an improvement over whatever was already on the market. The other 56 were all "me too" drugs. That's pathetic, really, 10 out of 66 likely to be an improvement.

Until recently, marketing was done ... directly to physicians, which still is the largest part of the marketing budget. But in 1997, the FDA permitted direct-to-consumer advertising. Talk about the significance of that.

Direct-to-consumer advertising was always allowed, but only under certain conditions. Those conditions were that the company advertising the drug had to say what the side effects were; had to, in some detail, spell out what the risks of the drug were as well as the benefits.

In 1997, that was changed. Now drug companies don't have to spell out the risks. All they have to do is refer the viewer or the listener or the reader to where they might go if they want to [to find about] out about risks. "Go to your doctor. Tell your doctor you have kidney disease or liver disease," [which is] something you would hope that your doctor would already know. But that's what they say at the end of ads. Or "Here's an 800 number." So they don't have to, when they're advertising drugs, say, "And, oh, incidentally, this may cause bone marrow suppression, or a rash, or it may ruin your liver." They don't have to say that anymore.

So that created a huge opening for direct-to-consumer advertising, which coincides with the age of the consumer. The consumer, for various reasons, is now more of an active participant in his or her health care. So suddenly you had all of these ads that don't go through the side effects in any detail, or the risks in any detail -- that now account for about $3 billion of pharmaceutical expenditures.

But they still refer the patient to go see the doctor. So why should this distort [the market]?

Well, because it is the age of consumerism. It convinces consumers that they need drugs that they might not need, that they need some drugs at all. ...

There is this kind of marketing that is designed to convince people that they need pills. It's designed to convince them that they need particular pills that happen to be more expensive, or just going on patent rather than coming off. Then, armed with this feeling, the consumer goes to the physician, who often just prescribes the pills. It's a buyer's market here. Doctors don't want to lose patients. They don't want to say no to patients. They're, in some sense, too busy to say no to patients. They are forced to see more and more patients more and more rapidly. It's faster to write out a prescription than it is to try to talk with patient and convince the patient that he or she may have been manipulated by these ads.

In addition, the doctors themselves are manipulated by the same ads, and also by what amounts to bribery from the drug companies. The drug companies turn up. They have $8 billion worth of free samples that they give to doctors. The doctors hand out the free samples to patients. It makes the doctor look good. The patient has free samples. But both the doctor and the patient, from that point on, are hooked on that particular drug. And believe me, it's not going to be a generic, and it's not going to be a drug that's just going off patent. It is going to be a new, newly patented, high-price drug. So in a sense, both the doctors and the consumers are sucked into a sort of "bait and switch," because sooner or later they will have to pay for[that drug.]

Doctors are supposed to be the informed actors in this picture. Isn't it a flaw that they're so easy to manipulate?

It certainly is. If I sound easy on the doctors, I don't mean to be easy on the doctors, because in the last analysis, it's the doctor who writes the prescription. That's why the drug companies spend so much time and so much of their marketing expenditures on the doctors. That's where the action is. Yes, [the companies] spend a lot of money on consumer ads. They spend an awful lot of money on Congress, on lobbying, on political campaigns. But the lion's share of their attempts to manipulate the situation goes to the doctors, because they are the ones who write the prescriptions.

They do this in part by perpetrating a gigantic fiction, and that fiction is that somehow they are not only in the business of selling drugs, but they are also in the medical education business and the medical research business. Now, that's nonsense. Their investors expect them to make as high profits as they possibly can. They are investor-owned businesses and their fiduciary responsibility is to their investors, which means selling drugs.

But they have managed to make a lot of people believe that they are also somehow educating them about drugs. That can't be. It's as though you look to beer companies to educate you about alcoholism. There is a conflict of interest there. Drug companies might educate you about drugs as long as they're talking about the benefits, but are they doing to talk about the down side? Are they going to say to a bunch of doctors, or patients, "Our drug isn't really very good; the other company makes a better drug?" No. It simply doesn't happen. It can't happen. But doctors pretend to believe that they're in the education business, because they both benefit from this. ...

Why doesn't the medical leadership do something about this? Why doesn't the AMA have their own objective data on drugs? Why are doctors so easy to corrupt?

Well, I wouldn't say they're any easier [than] anybody else. But they're no less easy, either. ...

The other thing I want to say is, the academic medical centers are abdicating their responsibility to teach pharmacology. There is very little teaching that goes on in medical schools now about drugs, about their down sides as well as their benefits, about classes of drugs, about cost-effective prescribing of drugs. To a large extent, the academic medical centers, the medical schools, have abdicated this and left that to the drug companies to do. They permit drug company representatives, salespeople, pretty much unfettered access to medical students, to interns and residents in hospitals. The salespeople are wandering the halls of almost every major hospital in this country, handing out freebies to the young doctors, telling them all about their new drugs, which, the evidence shows, the young doctors pretty quickly respond to and prescribe. And the medical centers stand back and let that happen.

Counter arguments. Drug companies argue that a big reason more money is spent on drugs than in the past is increased utilization.

There's no question that the increasing use of drugs is one reason for the increase in expenditures. There's no question about that. Pricing is only part of it. It's also the increased use, and some of these drugs are indeed great advances that probably do keep people out of the hospital or spare them surgery. But most of those were the result of NIH-funded research.

The "me too" drugs, I'm not at all convinced that they are a success story. There is no question that they are heavily promoted by the drug industry. The drug industry does not say, "You probably don't need these drugs." The drug industry says, "Yes, go out and ask your doctor about this drug." So I find that an odd sort of argument for them to make, that they're really trying to discourage the use of drugs.

They say R&D is enormously lengthy and expensive because the attrition rate is incredibly high.

Yes, it is. It is true that only a handful of the drugs that start out in testing make it through to FDA approval. That's one reason that the drug companies are turning their efforts to "me too" drugs, where you just have to twiddle a molecule a little bit to make essentially the same drug, or make the same drug for a slightly different use. ...

Isn't it unfair to single out the pharmaceutical companies? Surely there's a lot of waste and inefficiency in the rest of medicine.

There certainly is. The pharmaceutical industry isn't the only place where there's waste and inefficiency and profiteering. That happens in much of the rest of the health care industry. I think that drugs are perhaps on the front burner when we think about the exorbitant costs of our health care system, because it's here that the costs are rising faster than ever. It's here that there's so much distortion about what's actually going on. It's here that people are feeling it more, because Medicare recipients don't have any benefits for outpatient drug costs.

Companies argue it's important to keep this a largely private market to protect innovation, and that's why drug companies in other countries are less innovative. Over half of all drugs are produced here.

This is like Holy Roman Empire: It's not holy, it's not Roman, it's not an empire. This question has many of the same problems. Almost every element of what you just said is wrong. Let's look at the big drug companies first. Of the 10 top drug companies, five are European and five are American. Their innovation is much the same. Their turnout of new drugs is much the same. Their marketing budgets are much the same. Their profits are much the same. This, in fact, is a global industry.

All of them have the lion's share of their sales here, because prices are so much higher in the United States than they are in Europe and Canada. So it's sort of good public relations to portray themselves as quintessentially American businesses. They're not. Even in countries where there are price controls, these companies are doing extremely well. So that's the first thing that's wrong with your question.

The second is the implication that these are innovative businesses. They are not innovative businesses. They are giant marketing and PR machines that turn out predominantly "me too" drugs, and whose truly innovative drugs are based mainly on taxpayer-funded work. So they are not innovative. ...

What is going on here, when the pharmaceutical industry insists that they should be essentially left alone, is a threat. It's a threat to the American public. They are saying, "Don't mess with us. Do nothing about our obscene profits. Do nothing about these unsustainable increases in prices, or else we will not give you your miracle cures." Well, guess what? They're not getting them the miracle cures in the first place. But that is their very successful PR pitch. "We are the source of all miracles. Don't mess with us." ...

One thing that is insufficiently appreciated, because it's disguised by the drug industry's public relations, is the degree to which they are dependent on the government. They like to portray themselves as a sort of model of American free enterprise and ingenuity. Nothing could be further from the truth. They are an exemplar of free enterprise, only in the sense that they are free to charge whatever the market will bear in this country, and that they are free to decide what drugs they want to turn out. They would rather turn out another baldness drug than a drug that affects the Third World, or even a vaccine for Americans. So they are free, in that sense. They are free to charge what they want. They're free to decide what they're going to turn out.

But they are not an exemplar of free enterprise, when you look at the fact that they are utterly dependent on congressional favors and government-granted monopolies in the form of patents and FDA exclusive marketing rights. Patents are usually given for 20 years from the time you file that patent. During that time, it's illegal for any other company to sell the same drug. The FDA also has another form of exclusive marketing rights, and may approve a new use. They will give the drug a certain length of time that it can be sold without fear of any competition.

It used to be, about 20 years ago, that the time that a drug company had a monopoly was limited to the time of the patent minus the time it took for clinical testing, because that's usually done after the patent is issued and the time it took for the FDA to approve the drug. So in practice, the time that a company had to market a brand name drug free of any competition amounted to about eight years. Seventeen years in those days was the length of the patent, minus the time it took for clinical trials and FDA approval. That time is now about doubled. The patent life is now about 20 years. The time for clinical testing and for FDA approval is shorter. There are a number of maneuvers, thanks to an industry-friendly Congress, that allow them to stretch the patent life longer.

So now drug companies probably have on the order of 13-14 years to sell their brand-name drugs without fear of competition. After the exclusive marketing rights expire, then what's called generic drugs can enter the market. These are simply copies made by other companies. They have to be identical in terms of their effectiveness. The FDA does see they're identical. But they don't have to go through all the research costs. So after the patent has expired or the other exclusive marketing rights have expired, then generics can get into the market. As soon as generics get into the market, the prices drop steeply, on average to about 20 percent, one-fifth of what they were before.

So you can see that for a drug company that has a blockbuster -- that is, a drug that makes a billion a year -- everything depends on extending their right to market that exclusively, without generic competition. ... There are many, many ways to do that now. This is where, in my opinion, the industry's true innovative genius, lies -- in the multiple ways in which their legions of lawyers can extend the period of exclusive marketing and keep generics off the market.

If they've been successful with the federal government, they now face the states. If a state brought in price control -- this is now in the Supreme Court -- would the sky fall for drug innovation?

No, because they don't do much now. Drug innovation would come from the same place it comes from now. You know, this is a drug company choice, to concentrate on "me too" drugs and to rely on getting its innovative drugs from the academic medical centers. This is the choice that they make.

Might you be less willing to look at a more risky prospect if you had smaller profits, if we had Canadian-style prices?

I would hope, if there's some price control, and that price control includes some limitation on the use of "me too" drugs -- that is, a formulary -- that this would redirect the R&D efforts of the drug companies toward trying to discover and develop important new drugs, and not "me too" drugs. I think that that could be one result. It's not going to hurt the drug companies in terms of their profitability. Because the profits are so large, there's a lot of room there. If they stopped with the "me too" drugs, their marketing costs could be much less, and that's an even bigger source of savings.

The problem -- and this is an interesting thing -- the problem is not how profitable is the industry, in a sense. It's how much are the profits are increasing, because that's what investors want. The investment market is an odd thing. It doesn't look at what the profits are making. It looks at, "Are they more than they were yesterday? Can I sell my stock for more than I just bought it for?" So in a sense, investors say to the drug companies, "What have you done for me today? Never mind that you pulled in last year 18.5 percent of your sales in net profits. Never mind that. What's it going to be this year?"

Of course, no industry can keep climbing like that. They can't, and they haven't, in the last couple of years. They can't keep going up in these astonishing, stunning profits. It can't be done. But it shows how responding to their investors can, in a sense, put them between a rock and a hard place, and distort what they call innovation, so that it's the very opposite. It's less risky to make an empty "me too" drug than it is an innovative drug.

The states, [such as] Oregon, are talking about a functional marketplace. When we buy cars, we can go to Consumer Reports. Why can't we rely on drug companies for objective information? Why is it left to state and federal governments to fill in this gap?

You have a lot of stuff mixed up in that question. You have the research, and you have the states versus the federals. I'm going to have to break these down.

The state governments, as you say, are faced with a swelling Medicaid budget, and they have to balance their budget. Much of the swelling Medicaid cost represents the increase in drug expenditures. So they're well nigh desperate to get some handle on drug costs, and they're going at it in two different ways.

One, they're looking at the pricing. They're essentially pulling together the Medicaid patients and the uninsured, and in some cases, I believe, the Medicare population, who have no supplementary drug insurance, because ultimately the states are going to have to pay for this. So they're pulling them together in one population, and making the argument that they should be able to bargain with the drug companies for volume discounts, in much the same way that the Veterans' Affairs system does, or that the large HMOs do. They bargain for discounts. So the states are saying, "We ought to be able to do that, too." So that's one thing. They're looking at prices.

But they're also looking at "me too" drugs. They're saying, "Why should we pay for newly patented, brand name, 'me too' drugs, when there's no evidence that they're any better than generic drugs or older brand name drugs that are going to go off patent soon? Why should we do that?" So they're looking at what's called formularies, lists of drugs for various conditions, that are the most cost-effective drugs. They're saying, "We'll pay for these drugs. But we won't pay for the more expensive drugs, brand-name drugs, for which there's no evidence of increased effectiveness." They are the two ways in which the states are moving. ...

But in terms of the formularies to limit drugs to those that have been found safe and effective compared to things already on the market, it seems to me that the fundamental place to do that is in the FDA. The FDA should change its policy -- and this would probably take some enabling legislation from Congress. Instead of allowing drugs to be approved on the basis that they are better than sugar pills, they should be required to make the companies show how they compare with drugs already on the market. And until that happens, I don't think we'll truly get a handle on "me too" drugs.

So even before they're released there should be a higher standard of efficacy?

Absolutely. There's no standard now. It just has to be better than nothing. It has to be shown to be safer or more effective or substantially more convenient, or in some way an improvement over similar drugs already on the market, or generic drugs already on the market.

Who's going to do this job? Why isn't the medical leadership more involved in this? Why should it be left to state legislatures?

The problem is this: In the academic medical centers, the medical schools, the teaching hospitals, almost all of the NIH-funded research is basic research, the fundamental mechanisms of disease, early stage research. The research that looks at drugs, that evaluates drugs, clinical trials in human subjects, is funded mostly by the pharmaceutical industry, and they attach strings to that funding.

One string -- it isn't explicitly stated as such, but it is in fact a string -- is "Don't look at our new drug compared with other older drugs in the same family. Look at it either compared with placebos, or sugar pills, or look at it compared with a drug for maybe the same condition but of a different class, a completely different class. Or we're not going to give you the money for these studies."

That in fact is what happens. You see study after study that is really set up, designed by the company, to show what they want to find. The studies that do compare drugs head to head, a new drug with older drugs of the same class, are often funded by the NIH. The NIH does fund some clinical trials.

It's essential that it comes from an independently funded source, to be credible?

Well, it doesn't have to be from an independently funded source. It has to be designed; the data have to be collected; it has to be interpreted; the publication has to be independent. The funding can come from the company. I think it should. It always did -- but without the strings attached.

Now the companies design the studies in such a way that it's tilted toward their new product. They often keep the data, assert ownership of the data. They often write the papers. Maybe the author then signs off on the paper. They interpret the data. They analyze the data. So there are a lot of strings attached now, such that the drug company is intimately involved with the evaluation of its own products. There's an astonishing conflict of interest there, but it goes on. The medical centers, they want the funding, and so they sit still for this.

If we did have effective head-to-head studies for drugs, could we save a lot of money?

We could save an awful lot of money. The FDA itself indicates that 56 of the 66 newly approved drugs last year were "me too" drugs. If each of these drugs had to be compared with the best of its class already on the market, I would imagine that most of them would never reach the market. Nor would you see this constant marketing of drugs that are just like other drugs. ...

Do we as consumers have to play a role in evaluating treatments? We've so far been protected, with insurance, from the costs of procedures.

Well, I have mixed feelings about that. I'm very wary of any kind of scheme in the health care system that requires individuals to feel the pain of paying for the illness as well as the pain of enduring the illness. That seems to be a double burden. It seems to me that any decent society takes care of sick people, and that we should do the same thing. So I would hate to see consumers be forced to calculate, particularly sick and poor people, whether they can afford a drug they need. The issue is: Do they need it?

I think there, if you had formularies -- and these were done independently, and drugs were not added to that formulary unless there was clear scientific evidence that they were better than something already on the formulary -- if that were done, then I would not object to consumers having to pay extra for those drugs that didn't make it to the formulary. I think that would be fine. But they shouldn't have to pay for anything on the formulary.

Why shouldn't the drug companies be able to charge whatever the market will bear? Every other industry does. Why a different standard?

Well, there are a couple of reasons. One, drugs can be vital to people's health and even to their lives. If people are forced to forego those drugs, or, as many Medicare recipients do, play those drugs out by taking them in half doses, or sharing them with their spouse, or taking the drugs instead of paying for food or heat, then that is simply not right -- for people to be denied a vital thing so that drug companies can make higher profits.

Second, other companies are not living off of government-granted monopolies. General Motors does not have a government-granted monopoly on its cars. Toothpaste, there's not a government-granted monopoly. So the pharmaceutical industry enjoys great public support, not only in terms of patents and exclusive marketing rights, but also in terms of huge tax breaks -- this industry pays less than other industries in taxes -- and also in the R&D subsidization through NIH-funded research. So, in two ways, it's not like other industries.





posted june 19, 2003

MEDITATION FOR THE STUDENT BRAIN CAN REDUCE NEED FOR MEDS - COURTESY OF THE DAILY HEAL BLOG

Meditation And The Student Brain
Written by The Daily Heal on April 29, 2011 ·  Use 

Transcendental Meditation To Connect To Your CreativityThose of us from a somewhat older generation, now ripe with experience, can appreciate just how difficult it was to be young. Don’t get me wrong. Playing all day was a blast, but let’s face it, peer pressure and parental nudging put an unconscious strain on most of us that can make one wonder how we actually got out of it alive.

Now just imagine growing up in today’s fast(er) paced world. Added to the list are lightening fast technological advancements that could make anyone’s head spin round-and-round. It’s no surprise that the current generation might have some trouble when it comes to focusing.

Jeanne Ball, in this recent Huffington Post, takes a look at the effect of meditation on a student’s brain. According to Ball, a March 2011 research study, published in the journal Education, found that students who practiced Transcendental Meditation had a significant increase to their English and math scores. Even more important, says Ball, is that meditation allows students the ability to connect to their creativity.

    When you see a classroom of high school students sitting quietly with eyes closed, meditating together — kids of diverse racial and ethnic backgrounds — it’s awe inspiring. How is it that they can be so peaceful and absorbed? It’s because during TM practice, the mind settles inward spontaneously, led by its own nature to seek greater satisfaction. In an effortless way, the technique allows the mind to access reserves of energy, creativity and calmness that reside within everyone.

Read more on using Transcendental Meditation in the classroom here.

The Daily Heal: Meditation News

TUC GENERAL CONGRESS SEPTEMBER 13TH 2011 - AEP MOTION 54 - " A Call for a National Review of the use of psychotropic drugs with children of school age"- PASSED OVERWHELMINGLY- DUE TO CONCERN OF EDUCATION AND HEALTH UNIONS ABOUT THE INCREASING 'RISK OF HARM' TO CHILDREN IN THE U.K. FROM OVER-PRESCRIPTION OF PSYCHOTROPIC DRUGS

Kate Fallon from the AEP, 
Congress I am here today to ask you to support our call for an urgent NATIONAL REVIEW into psychotropic drugs, such as Ritalin, with school aged children.


We are concerned that not enough is known about the long term effects of such powerful drugs on the development of children’s brains.

We receive increased numbers of reports from our members that children with behavioural difficulties are being prescribed drugs without full discussions with other professionals to see if other strategies/approaches could be used instead of, or at least alongside, the medication.

Very often these drugs are administered to the children by support staff in school and we share the concerns expressed by the GMB about the responsibilities placed upon their members in this respect.

We fear that the drugs are being seen as a “quick fix”.

Behaviours develop over a long period of time, often with a range of complex causes; we can’t “cure” the behaviours we don’t like with a quick fix of medicine. They usually require careful management by all the adults around the child.

In 2013 we’re expecting new criteria for the definition of mental illness to be adopted here in the UK. These criteria will lead to many more children being diagnosed as mentally ill, based on reports of their behaviours.
 A shy child could be diagnosed with social anxiety; a sad or temporarily withdrawn child could be diagnosed with depression. 
These are conditions which are also likely to be treated with medication – and under these circumstances, Congress, we will be putting potent drugs into children with little or no understanding of what it will lead to.

In a society that wants quick results using drugs to improve behaviour is very tempting. But there can be other ways of improving children’s behaviour which typically involve time and energy from people. 
Simply relying on medication in isolation is no solution; we must foster a more collaborative approach to the treatment of school-aged children with conditions such as ADHD.
We should ensure that teachers, school support staff, educational psychologists and healthcare professionals are involved alongside the parents and doctors to try to develop consistent approaches and support for the children.

Consistent approaches and support that are not solely reliant on medication, or on increasing the dosage of more tablets at the start of the day when the drugs don’t work, but those that involve all the adults who work with the child and utilise all the skills and resources which they have.  The bottom line is that this approach must answer a single question: what will work best for this child and the people around them and will lead to long term health and well being?

The National Institute for Health and Clinical Excellence (NICE) has issued guidance on the use of psychotropic drugs with children

It believes that there is no need to review that guidance…

It says that they don’t have the evidence to review the guidance …

They don’t have evidence because the Department of Health doesn’t collect the data…

We have evidence that the current guidance is not being followed. For example, children under 6 are being prescribed the drugs but there is no monitoring of such practice.

If we fail to review our practices we run the risk of even more children being prescribed with drugs whose long term effects are not categorically known to us.

We run the risk of committing children to long term drug use and of committing the long term spending of public money to increase the profits of pharmaceutical companies, public money which could go some way towards funding more adults being available to work directly with children. 

Congress, I urge you to support this motion to instigate a full and urgent review into the use of psychotropic drugs with school aged children and into the long term effects of the use of these drugs.

Congress, I move.

PASSED OVERWHELMINGLY AT NOON ON THE 13TH SEPTEMBER 2011.


WELL DONE KATE THE GOVERNMENT NEEDS TO LISTEN TO THE AEP, BPS, GMB, NUT AND NOW THE TUC CONGRESS.