Volume 62, No. 12 December 2006

THE PERILS OF "HEALTH CARE"

With the party of Hillary Clinton in the ascendancy, we will expect more pressure to "just get it done" and enact a national, monolithic (non-"fragmented") "health care delivery system," with bipartisan support, of course.

We can expect endless repetition of the demand to spend more on "keeping people healthy," instead of having a system focused on disease. For years, a subtle change in language has helped to drive policy in this direction. Instead of the "practice of medicine" or the receipt of "medical care" we have the "delivery of health care." AAPS avoids cooperating with this semantic shift as much as possible.

"Health care" ought to mean accepting one's individual responsibility to take care of one's health, as by following Grandma's advice: Get plenty of fresh air, sunshine, and exercise. Eat your vegetables. Don't smoke or drink to excess. Wash your hands. Don't fool around; get married and be faithful to your spouse. Grandma also may have made you take your vitamins, and/or your cod liver oil. She frugally saved her pennies so she could pay the doctor if somebody was really sick. But she was just an old wife.

Today we have credentialed, government-sponsored "health care providers" to substitute for Grandma or to shove her aside and even to replace doctors. Increasingly, approved providers are backed up with the police powers of the state. The FDA and Codex may ban home remedies, while mental health screening, disease registries, and mandatory vaccines and psychoactive drugs proliferate. Everyone is to be protected against second-hand smoke, messages promoting sexual morality, nonconformist doctors, and direct payment of one's own medical bills and subjected to the nanny state.

How U.S. Medicine and European-Style Health Care Differ

In privately controlled systems, infrastructures are designed to cure maladies, promote full recoveries, and shorten treatment times. But in politically controlled systems, money flows to issues of concern to politicians, explains Linda Gorman. At any one time, less than 5% of the population in most industrialized countries requires sophisticated medical care. "In terms of votes, the concerns of the sick are inevitably outnumbered by the concerns of the well" (The History of Health Care Costs and Health Insurance: a Wisconsin Primer, Wisconsin Policy Research Institute Report, October 2006).

Under socialized medicine, everyone can visit a doctor frequently, for minor ailments. But for procedures, waiting list management is a major industry in Canada. Acute care facilities deteriorate. Whether U.S. citizens are less healthy, or if so whether that is related to the fact that the medical system remains half private, is hotly debated. But 5-year survival rates for cancer are distinctly better in the U.S., and adverse events in U.S. hospitals considerably less frequent (ibid.).

Lifestyle Choices

As costs mount, once-private behavior becomes everybody's business. It is said that 75% of health-care costs are lifestyle related. Gorman points out that this must be exaggerated. After regulatory costs eat up 10-20%, this would leave no more than 15% of $1.88 trillion, or $285 billion, for sickness or injury unrelated to lifestyle. Arthritic conditions alone cost $189 billion; Parkinson's disease, $25 billion; schizophrenia, $22.7 billion; bipolar disorder, $45.2 billion; gastroesophageal reflux, $9.3 billion. But the lifestyle police are being deployed, and the AMA has a new crusade to promote taxes on sugared soft drinks, to fund obesity education.

Culling the Herd

The money is in reducing the number of sick or disabled persons, and/or restricting their care, even if it is impossible to eliminate the causes of sickness. The direct route is being used with increasing frequency. One-third of British doctors admit to having hastened a patient's death by more than a month. Belgium has allowed euthanasia since 2002, and Switzerland permits assisted suicide (Daily Mail 10/15/06). The Royal College of Obstetricians and Gynaecologists is debating the issue of killing disabled newborns (www.rcog.org.uk/). In the U.S., AAPS receives "anecdotal" reports of hospice staff telling families that patients are "forbidden" to have food or drink, or of high doses of morphine being used in debilitated patients who are not complaining of pain.

The less direct route is to cull physicians skilled in caring for the sick. First, the Relative Value Scale makes it impossible to reward higher competence. In fact, to receive higher Medicaid funding, a facility must employ nurse practitioners. Then, the "hold harmless" clause in managed-care contracts makes it impossible for physicians to be paid at all for rendering "covered" but "medically unnecessary" (for example, "futile") services. Of course, screening visits, even if they certify that care is unnecessary, are always paid for.

The latest scheme is "health plan tiered networks," which encourage patients to see physicians in the lowest cost tier through lower premiums or cost sharing. The high tiers are narrow designed, as Dr. Huntoon explains, to assure that everything eventually "goes to ground."

In a free market, people choose to pay more for higher quality. In a socialized market, low cost is being defined as high quality. Economic incentives in the free market are deplored: patients are too stupid or distressed, and medical care too complex or urgent to permit shopping. But if used to starve out noncompliant "providers," incentives are applauded.

The price of "universal health care" is your money and your life. Everyone must pay for the system. And it will, as promised, reduce or eliminate the care of the sick.

Upside-Down Coverage

Medicare, the American single payer, protects against relatively small losses while providing no protection at all for the small number of people who incur large losses by spending more than 150 days in the hospital. Unlike virtually all reputable private plans, there is no cap on personal liability. In 1997, nearly 40,000 Americans enrolled in Medicare had an average of $22,000 in liabilities per person, which might or might not have been covered by a private supplemental policy.

Decreases in mortality rates for 55 to 64-year-olds began several years before Medicare's inception, suggesting that declines in 65 to 74-year-olds, beginning several years later, were unrelated to the program. In the decade following its founding, Medicare had no effect on mortality.

Under socialized medicine, patients don't receive a bill, but also might not receive the care. Comparative 5-year cancer survival rates for the U.S. and Europe, respectively, are: pros- tate, 56% v. 81%; melanoma, 76% v. 86%; colon, 47% v. 60%; rectum 43% v. 57%; breast, 73% v. 82%; uterine, 73% v. 83% (Cancer 2000;89:893-900). The percentage of hospitalized patients with adverse events was: 7.5% in Canada; 2.9% in Utah and Colorado; 16.6% in Australia; 3.7% in New York City; 10.8% in London, and 12.9% in New Zealand.

See Gorman, Wisconsin Policy Institute, op. cit.

Shopping for Medical Care

Some assert that price comparisons are unrealistic in medical care because of its urgent nature. But the leading reason for office visits is general medical examination (65,000 of 889,980 in the 2002 National Ambulatory Medical Care Sur-vey), followed by "progress" visit (41,000) and cough (26,000). Others in the top 10 were routine prenatal checks, throat symptoms, hypertension, knee symptoms, well baby examination, obtaining medication, and stomach pains. Most of the top 20 (www.cdc.gov/nchs/data/ad/ad346.pdf) were also usually elective and price elastic. Price competition for such services is likely to have an impact on the cost of emergent care also.

Massachusetts Watch

At the annual meeting of the Massachusetts Health Underwriters Association, the man in charge of The Connector (TC) reported that it took 6 weeks to order a printer through the bureaucratic process, and 2 weeks to remove the shrink wrap. It took only 2 weeks to get the scanner ordered. There are six employees, and they're adding one a week, but they didn't have health insurance yet an oversight by legislators.

In an Aug 17 filing to support general obligation bonds, Massachusetts officials said the plan will increase state health spending by $276.2 million in 2007 a $151 million boost over what the public was told the plan would cost as recently as April. As writers on HealthyBlog noted, "They can say whatever they want to the public, but they can go to jail for fibbing to Wall Street" (Sally Pipes, Wash Times 11/5/06).

Attorney General Thomas Reilly has sued a company that sells low-cost policies to small businesses and students. While noting that MEGA Life needed to improve its consumer information, Insurance Commissioner Julianne Bowler said she thought TC should consider offering such plans. But "Healthcare advocates" promise to fight inclusion of MEGA Life and similar limited-coverage plans (Boston Globe 10/24/006).

Medical Justice Offers AAPS Members 10% Off

In his presentation at the 2006 AAPS meeting, neurosurgeon Jeffrey Segal, M.D., described the ways in which his organization helps fight frivolous litigation. Medical Justice will now offer a 10% discount for AAPS members see enclosure.

If You Can't Opt Out, Help Those Who Do!

Bruce Schlafly, M.D., a hand surgeon in St. Louis, writes that it is best for him to participate with a variety of different private insurance companies because he frequently provides emergent care to injured patients. He is a nonparticipating physician in Medicare, but is not completely opted out.

"Nevertheless I recognize that the most effective force right now in the U.S. for preserving private...medicine is the self-pay, cash medical office or clinic. Every cash transaction between patient and physician...is a blow for freedom."

Dr. Schlafly urges all physicians, even those who participate with third parties, to support cash-based practices through their AAPS membership, and "to recognize that these medical practices are doing much to preserve the freedom that we still have in our private practices."

Who's in the Driver's Seat?

It seems clear that government and third parties control the agenda on how medicine is to be practiced. Physicians are there as token representatives or mere facilitators to third parties, writes David McKalip, M.D., a neurosurgeon in St. Petersburg, FL. "The Third Parties insist that if they merely micromanage medical care enough, they can solve [the] economic problems. What they really mean is: deny care to patients, demonize and damage doctors who refuse to cooperate with them, then take home the profits and get reelected."

The AMA's Physican Consortium for Performance Improvement (PCPI) seems to indicate that the individual needs or rights of patients are secondary to larger "social obligations." It states: "The tradition of physician professionalism is grounded in the obligations to society and individual patients to achieve optimal health outcomes and to responsibly use health care assets." Also: "[U]nnecessary and inappropriate clinical interventions that are delivered `inexpensively' serve no useful social goal."

"Are we in the Soviet Union?" asks Dr. McKalip. "What happened to clinical goals for the individual patient living in a free American society?" He notes that "arbitrary designation of some procedures as `medically unnecessary' by payers and government" show a view very different from physicians'. Cost decisions need to be moved into the hands of patients through Health Savings Accounts and high-deductible catastrophic insurance, he concludes. And organized medicine should reflect the values of free people, not of government dependents.

Exclusions Reach Record Levels

In FY 2005, the Office of the Inspector General excluded a record-breaking 3,804 providers from Medicare and Medicaid an increase of 15.5% over 2004 and 16.2% over 2003. The most common reasons were license revocation (53%), health-care related crimes (20%), and patient abuse or neglect (8.5%).

"Exclusion is one of the enforcement avenues that [OIG is] emphasizing, in part, because they don't have to go through as much red tape and they can do it on their own," stated attorney Bill Maruca of Pittsburgh (MCA 10/16/06).

Convictions for fraud and abuse also reached a record level 523 in FY 2005 and 1,689 health care fraud criminal investigations were opened.

Medicaid Fraud Control Units (MFCUs) raked in a record $709 million in restitutions, fines, and civil settlements. MFCUs will be hiring more prosecutors and investigators, and teaming up with other local government agencies. The majority of prosecutions are for alleged abuse, neglect, and poor care.

EMTALA Expanded

As of Oct 1, any hospital with "specialized capabilities" must comply with the Emergency Medical Treatment and Labor Act, even if it does not have an emergency room. It will have to create an infrastructure for accepting and stabilizing EMTALA patients (ibid.).

Error Leads to Criminal Charges

Wisconsin Attorney General Peg Lautenschlager's office took the unprecedented step of filing felony criminal charges after a patient died from an unintentional error. Nurse Julie Thao inadvertently gave an epidural anesthetic intravenously, instead of penicillin, to a 16-year-old woman in labor. Cardiac arrest and death ensued. Thao was charged under a state statute normally reserved for cases involving neglect of a nursing home patient and could face up to 6 years in prison.

"The actions, omissions and unapproved shortcuts of the defendant constituted a gross breach of medical protocol," stated MFCU investigator Gregory Schuler.

Dana Richardson, VP for quality at the Wisconsin Hospital Association, said "it is cruel to allege that this mistake constituted criminal conduct." The charge "accomplishes nothing other than to compound the anguish of this situation."

Nurses are already stressed by sicker patients, new technology, increased paperwork demands, and requests for overtime, said Gina Dennik-Champion, executive director of the Wisconsin Nursing Association. The risk of prison time for mistakes could discourage entry into nursing, decrease access to care, and cause a setback in the trend toward more transparency about mishaps. See: Wisconsin State J 11/3/06; Insider, Wisconsin Medical Society 11/3/06.

On Blowing the Whistle: a Pharmacist's Insights

On Feb 6, 2005, Paul Kornak, a nonphysician employee of the Stratton VAMC in Albany, NY, pled guilty to fraud and criminally negligent homicide, and was sentenced to 6 years in prison. His forgeries involved manipulating medical backgrounds so that patients would qualify to participate in lucrative drug studies. At least one veteran died, and 64 others were harmed by illicit cancer research. Though Kornak deserved punishment, writes pharmacist Jeffrey Fudin, he was a convenient scapegoat for a decade of criminality that had preceded his employment.

Some patients were coerced into participation, and some placed in studies without informed consent. Physically incompatible drugs were given. Dangerous doses and unstudied combinations were prescribed. When he refused to cooperate, Fudin received a memorandum charging him with "patient abuse for failure to dispense medication as required by the oncologist." As he climbed the chain of command to report his observations, he was told: "I will bury you." Eventually, he was fired. The struggle consumed a decade of his life. For details see www.vawhistleblower.com .

To survive, Fudin said he had to become the predator rather than the prey, and "to make the message clear that anyone guilty could potentially be exposed." He documented his findings meticulously. He advises hiring an attorney who specializes in employment law, not health care law (Am J Health-Syst Pharm 2006;63:2262-2265). To assist other VA practitioners, he helped form a coalition: www.vawbc.com.

Profits Allowed, Washington Court Rules

The Washington State Supreme Court held in an unanimous opinion (9-0) that RCW 19.68.010, an antikickback statute, does not prevent medical professionals from making a profit by providing goods or services to patients. Plaintiffs in a Spokane class-action suit had alleged that profiting from the sale of medications violated the law that prohibits paying or receiving anything of value in return for referral of a patient. A Superior Court agreed. The Supreme Court in reversing took the "common sense" position that the legislature intended to prohibit kickbacks, not profits (WSMA memo 10/20/06).

Most Dangerous States

Public Citizen's Health Research Group has published a ranking of states based on the number of serious disciplinary actions against physicians, using 3-year averages to counter the effect that in small states, one or two actions can greatly affect the ranking in a single year (HRG Publication #1737). The "worst states" are Hawaii, Delaware, Wisconsin, Minnesota, Maryland, Nevada, Rhode Island, Arkansas, South Carolina, Washington, Tennessee, Mississippi, Michigan, Connecticut, and Florida, with disciplinary rates ranging from 1.44 to 2.46 per 1,000 physicians. The "best states" are Wyoming, Kentucky, North Dakota, Alaska, Oklahoma, Arizona, Ohio, Montana, Colorado, and West Virginia, with rates ranging from 10.04 to 5.33 per 1,000. Public Citizen did not consider the possibility that the "worst states" might have the best doctors. It recommends pressuring legislatures and licensure boards to mete out more discipline to assure that doctors practice in the "best manner." Apparently, one out of 100 physicians need to be culled each year.

Powerful state licensure boards are subjected to absolutely no oversight. The case of Dr. Terry Bennett, who spent $60,000 defending his right to free speech in New Hampshire (AAPS News, November 2006), has raised questions about how much money was spent on the state's side of the battle. Bills asking for a judge to review which cases go forward, or for a committee to hear appeals by doctors who think they're being railroaded, have to date always failed. It's time to correct the injustice (www.seacoastonline.com , letter 10/22/06).

Correspondence

Lifelong "Certification." Expressing skepticism about innovations such as "clinical pathways" is one of the quickest ways to get certified as a "disruptive physician." Note that this type of certification is the only type that requires no re- testing, or re-certification. It's good for life.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY

Disparity. Reducing racial and ethnic disparities is code for justifying single payer by saying that since we have shown that the U.S. system is racist, the government must take it over to ensure equal care for all. The racism is made clear by a raft of studies comparing health outcomes for black people to outcomes for white people and finding that black people are worse off. As process equality is a prime aim of the socialist progressive types, it doesn't matter a whit that the outcome is likely to be equally lousy. They live in a utopian vision that is not data driven. Never mind that their studies omit niggling details like socioeconomic status, marital status, out-of-wedlock births, illegal drug use, tobacco use, and the existence of various comorbid conditions. Or that most measures are process ones that haven't been shown to affect health outcomes at current levels number of prenatal visits being the prime example.

If you wish to get rid of income disparity you have to go to a pure communist system in which goods are given to people according to their needs, as determined by their political masters. Market economies produce income disparities via different talents, technologies, and consumer demands yet even the poorest tend to live pretty well. The biggest income disparities occur in kleptocratic thug economies. And where has confiscating wealth led to better conditions for the poor?
Linda Gorman, Independence Institute, Golden, CO

The Value of Insurance. As John Goodman noted, if you left a $100 bill on the floor of the Parkland emergency room, it would be snatched up in a flash. But if you left a Medicaid card, worth many thousands of dollars in medical care, it would still be there at the end of the shift. Why? Because Parkland gives away care for free, and the uninsured are treated the same as everybody else.
Greg Scandlen, Consumers for Health Care Choices

The Real Goal. "Health care reform" is not about medicine which is just a pawn to advance a new form of governance. If we lose here, we'll be debating another national crisis. Other "broken" systems will be attacked one by one, until the ultimate goal is achieved: can you say the United States of Socialist America?
Joseph Lee Pugh, Diamondhead, MS

We Need More Uninsured, Not Fewer. Mandates like those in Massachusetts drive everyone into the hands of insurance companies, which then proceed to take everybody's money, force their will on doctors, and even more damaging on patients. In a free market, people should have the right to determine their own medical care without interference from either government or insurance companies.
Kenneth D. Christman, M.D., Dayton, OH

Mental Health Screening. All of the proposed plans, whether for schoolchildren or the elderly, are misdirected and dangerous. Claiming to be case-finding, they are actually case- creating and drug-pushing. Except for the obviously insane, who need no special screenings, "mental illness" is impossible to diagnose on brief inspection. We all feel upset at times, but those upsets are almost always reversible. Giving a mental diagnosis to a person who happens to be experiencing some emotional distress is likely to make him feel much worse possibly for a very long time. The frightening notion that one may be suffering from a mysterious "disease," which will somehow be determined by "inspectors," tends in itself to produce mental disturbances for which the main treatment today is addictive, brain-impairing drugs.

During the Middle Ages, witch-hunters searched for birthmarks supposedly indicating a compact with the Devil. Today's proposed mental health screenings resurrect those inquisitional tactics. Recall that Dr. Karl Menninger once called the DSM the contemporary equivalent of the 16th century Malleus Maleficarum, the witch-hunter's manual. It is also an attempt to parse moonbeams.

In the Septuagint, the first Greek translation of the Hebrew Bible, the key word in the statement "thou shalt not suffer a sorceress to live" (Exodus 22:17) is "pharmacos," usually rendered in English as "poisoner."
Nathaniel S. Lehrman, M.D., Roslyn, NY

Hubris. In the war on our civilization, true science is corrupted, and ersatz science is replacing independence in academia. The so-called science of psychiatry is medicalizing issues hitherto governed by family, religion, and society. Would- be philosopher-kings are taking on the responsibility for husbanding the resources of the entire planet, and regulating the balance of nature making such irrational pronouncements as the need to reduce the human population by nine-tenths. These are not aberrations but are gaining momentum. I did not expect help there, but did verify the absence of the word "pride" in the DSM- IV, the contemporary, consensus-defined catalog of psychiatric illnesses.
Thomas Dorman, M.D., Federal Way, WA
from Facts, Fiction & Fraud in Modern Medicine, v11n3

Legislative Alert

In April 2002, President Bush signed Executive Order 13263, which established the New Freedom Commission on Mental Health. The commission was charged with conducting a comprehensive study of the mental health delivery system in the United States, both public and private, and to make recommendations that could be implemented at the federal, state, local, and private levels to improve the system.

The Commission organized itself around a few key objectives: improve outcomes of mental health care; promote collaborative community level models of care; maximize existing resources and reduce regulatory barriers; use mental health research findings; and promote innovation, flexibility, and accountability at all levels. The final report, which was released in July 2003, was entitled "Achieving the Promise: Transforming Mental Health Care in America." It emphasized building a system that is evidence based, recovery focused, and consumer and family friendly. It had six goals and a series of recommendations to reach each goal.

Goal #1: Americans should understand that mental health is essential to overall health. A national strategy is needed to reduce the stigma for seeking care and to prevent suicide.

Goal #2: Mental healthcare should be consumer and family friendly. Comprehensive state mental health plans, and individualized care plans for adults and children, should be developed.

Goal #3: Disparities in mental health services should be eliminated. Quality and access to care should be improved.

Goal #4: Early mental health screening and assessment and referral services should be common practice. School mental health programs should be expanded and improved, and screening for mental disorders should be done in primary health care and across the life span.

Goal #5: Excellent mental health care should be researched and delivered. Public/private partnerships to promote evidence-based practices should be developed.

Goal #6: Health information technology should be used to coordinate and improve access to care.

Model Programs

Two of the model programs the New Freedom Commission on Mental Health promoted, among many, are the Columbia University TeenScreen Program (mental health screening) and the Texas Medication Algorithm Project (TMAP). The former was to ensure that schools play a larger role in the mental health of students, and that all youth are offered screening for a mental health check-up using a computer-assisted questionnaire that screens for mental illness and suicide risk. The latter was to develop algorithms and guidelines as well as consumer education materials for treating serious mental illnesses.

Of all of the goals and recommendations, the two that have caused the most public outcry are goals 4 and 5, which concern early mental health screening and evidence-based mental health care, respectively. The mental health screening issue has received the most public attention to date, while the evidence- based goal in general and TMAP in particular have led to many questions about alleged corruption in psychiatry. TMAP will be addressed in an upcoming issue of AAPS News.

TeenScreen: Dubious Diagnosis

On its website (www.teenscreen.org/) TeenScreen claims:

After the release of the NFCMH report, many family groups, professional associations, education groups, legislators, doctors, and watch-dog organizations publicly opposed mental health screening in general and TeenScreen in particular. These groups included AAPS, Eagle Forum, International Center for the Study of Psychiatry and Psychology, Alliance for Human Research Protection, Liberty Coalition, Citizens Commission on Human Rights, EdWatch, Able Child, Texans for Safe Education, and Citizens for Health. AAPS expressed a number of concerns: (1) screening instruments are not validated or effective; (2) children may be over-diagnosed with mental illness and overly medicated with potentially dangerous drugs; (3) the program violates constitutional limits on government and interferes with the right of parents to raise their children.

According to a study of some 1,700 high school students who completed the Columbia SuicideScreen, the specificity was 0.83 and the positive predictive value only 16% (Schaffer D et al. J Amer Acad Child Adolesc Psychiatry 2004;43:71-79). False positive tests mean that normal children could be labeled and given therapy, probably including drugs, for nonexistent problems. Additionally, the U.S. Preventive Task Force found no evidence that screening reduces suicide attempts or mortality (www.ahrq.gov/clinic/3rduspstf/suicide/suiciderr.htm). Currently available data strongly suggest that the screening instruments do not work and can cause more problems than they might potentially solve. In fact, according to the Centers for Disease Control and Prevention (CDC), there is actually a decline in teen suicide and not an increase as those who support the mental health screening programs suggest. As reported by the Associated Press, the CDC says that suicide among American teens fell almost 24% in the decade preceding 2004. The suicide rate for those aged 10 to 19 fell from 6.2 per 100,000 in 1992 to 4.6 per 100,000 in 2001. The number of suicides also fell during that period, from 2,151 to 1,883 (www.psychsearch.net/teenscreen_cdc.html).

A lawsuit has been filed against TeenScreen by parents whose daughter was allegedly screened at her government school without parental consent and as a result was falsely diagnosed with an obsessive-compulsive and social anxiety disorder. (Rhoades and Rhoades v. Madison Center et al., U.S. District Court for the Northern District of Indiana, South Bend Division, case number 3:050CV-00586-JTM-CAN: see www.psychsearch.net/teenscreen_lawsuit.html.)

Not only does the data suggest that the screening instruments do not work but there is also great concern about the psychiatrization of everyday life. There is not much if any research at this time to support the biomedical model of mental illness, i.e. chemical imbalances or genetic causes, which is foundational to psychiatry. There are also questions about the validity of the diagnostic tools used in psychiatry. In reference to the former concern, mental health criteria are quite vague and subjective. Even the Surgeon General acknowledged the same in his 1999 Report on Mental Health, which stated: "What it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures." The report continued:

The very committee in the American Psychiatric Association that created the Diagnostic and Statistical Manual stated in the 1994 version of the DSM-IV:

Thus, the lack of supporting data for the diagnostic tools and screening instruments used in mental health programs should lead those who have the power to promote them to be very careful and conservative especially when it comes to bringing young children into the mental health system.

Questionable Treatment

Legitimate concerns about the diagnostic instruments are magnified upon consideration of the risks of pharmaceuticals used in psychiatry especially their use with children.

The FDA recently included a black-box warning for antidepressants used in children: "It has been determined that anti-depressants can cause an increase of suicidality in children" (www.fda.gov/CDER/DRUG/antidepressants/PI_template.pdf). There are also major concerns with the use of psycho-stimulants such as Ritalin in children diagnosed with attention-deficit disorder (ADD). Such drugs have been shown to be ineffective in changing long-term outcomes such as peer relationships, social or academic skills, or school achievement, according to an article quoted by the Surgeon General. Worse, the drugs are now known to be pose the danger of neurologic damage to some children. A recent review found almost 1,000 reports of mania or psychosis linked to the drugs including Adderall, Concerta, Ritalin and Strattera, according to the Alliance for Human Research Protection (www.ahrp.org/cms/content/view/112/28). The review covered the period from January 2000 through June of 2005 and included reports from the FDA and drug companies based on adverse event reports. Not only were there reports of mania and psychosis but there were also reports of hallucinations.

The concerns over misprescribing of psychiatric drugs in children are not limited to psychostimulants and antidepressants. There is also growing concern about the increased use of antipsychotic medicines as well.

A recent study by William Cooper, M.D., M.P.H., associate professor of pediatrics in the Child and Adolescent Health Research unit at the Monroe Carell Jr. Children's Hospital at Vanderbilt, found that the overall frequency of antipsychotic prescribing increased nearly fivefold in just 6 years: from 8.6 per 1,000 U.S. children in 1995-1996 to 39.4 per 1,000 in 2001- 2002. The study used data from the National Ambulatory Medical Care Survey and the National Hospital-based Ambulatory Medical Care Survey. The focus of the research was children aged 2 to 18. During the period 1995-2002, there were 5.7 million office visits by U.S. children during which an antipsychotic was prescribed. The indication for 53% of these prescriptions was a behavioral or affective disorder. Antipsychotic drug use for such problems has not been studied in children. Moreover, almost one- third of the antipsychotic prescriptions were written not by psychiatrists but by pediatricians or family physicians. (The Reporter, Vanderbilt Medical Center, Mar 17, 2006: see www.mc.vanderbilt.edu/reporter/index.html?ID=4601).

Whose Agenda?

Although many states have moved forward with some of its recommendations and federal funds have followed, the real power lies with the Federal Action Agenda (FAA). The Substance Abuse and Mental Health Services Administration of the Department of Health and Human Services (HHS) released the federal plan entitled "Transforming Mental Health Care in America: the Federal Action Agenda First Steps" in July 2005. This contains the recommendations from the New Freedom Commission that implement the plan more broadly throughout the federal government. According to the FAA, it is a collaborative product of HHS, the Social Security Administration, the Department of Housing and Urban Development, the Department of Justice, the Department of Labor, and the Department of Veterans Affairs (see www.samhsa.gov/Federalactionagenda/NFC_preface.aspx). It would not be surprising to find out, especially with the interest in utilizing electronic medical records, that other government agencies such as Homeland Security and the Department of Defense are also involved in the federal plan.

Although both Columbia University's TeenScreen program and the Texas Medication Algorithm Project are not included in the FAA, possibly owing to grassroots pressure, those efforts are still moving forward in the states with the blessing of the federal government.

The agenda is very ambitious. As the FAA states, "it implies profound change not at the margins of the system, but at its very core."

What You Can Do

For more information on mental health screening, see "The Dangers of Universal Mental Health Screening" DVD with Karen Effrem, M.D., from www.edwatch.org. Consider signing and distributing the petition to stop TeenScreen: www.petitiononline.com.

Michael D. Ostrolenk is a member of the AAPS government affairs team in Washington, D.C.