Below is a press release that we here at Prescription Access Litigation (PAL) issued today. Three members of the PAL coalition filed a formal objection to a settlement proposed in the class action lawsuit, Carpenters & Joiners Welfare Fund et. al. v. SmithKline Beecham, (U.S. District Court, Minnesota, Case #04-cv-3500). Details of the settlement are at www.pediatricpaxiltppsettlement.com.

A key component of PAL’s mission is to ensure that settlements of pharmaceutical class action lawsuits genuinely benefit the consumers, health plans and union benefit funds on whose behalf they are brought. When we learn of a settlement that does not benefit them, that makes it harder for them to derive a benefit, or that undermines their rights, we work with our coalition members to object to the settlement. And that is what our members Sergeants Benevolent Association Health and Welfare Fund, AFSCME District Council 37 Health and Security Plan and IUOE Local 4 Health and Welfare Fund did yesterday. Here is the press release:

__________________

FOR IMMEDIATE RELEASE

August 1, 2008

Contact:
Wells Wilkinson
(617) 275-2869
wwilkinson@communitycatalyst.org

Labor Unions File Objection to Paxil Pediatric Class Action Settlement
Union Benefit Funds Criticize Settlement as Unfair, Call on Court to Reject it

Boston, MA – Three labor union benefit funds filed a formal objection yesterday to the proposed $40 million nationwide settlement of a class action lawsuit against GlaxoSmithKline (NYSE:GSK). The lawsuit alleged that Glaxo defrauded health plans, union benefit funds and other “third party payors” by failing to disclose the increased risk of suicidal thoughts and behavior among children and adolescents taking the prescription antidepressants Paxil® and Paxil CR®. The $40M settlement is to reimburse third party payors for payments they made to pharmacies for Paxil prescribed to children and adolescents from 1998 to 2004.

The union benefit funds objected to the settlement because the proposed claims process requires information that many health plan and benefit funds don’t have, or could only get through a burdensome, unreasonable process that would be more work than the potential claim was worth. The objectors are Sergeants Benevolent Association Health and Welfare Fund, AFSCME District Council 37 Health and Security Plan and IUOE Local 4 Health and Welfare Fund. They provide prescription drug coverage for more than 320,000 union members, retirees and their families.

Under the terms of the proposed settlement, TPPs can be reimbursed up to 40% of their costs for Paxil prescribed for Major Depressive Disorder, while all other prescriptions for Paxil for other conditions will only be reimbursed at 15%. This requires TPPs to list a diagnostic code for each and every pediatric prescription for Paxil that they paid for during the seven year period. The objectors challenged this distinction, arguing that almost no one will really get a 40% refund, because almost no TPPs have diagnostic codes for the prescriptions they pay for.

In addition, millions of prescriptions for Paxil were written during the seven years covered by the lawsuit (1998-2004), yet the settlement requires any claim for more than $1,000 in reimbursement to include exhaustive details regarding every individual prescription of Paxil paid for during that seven-year period.

The funds also objected to other requirements, including the way that TPPs are required to calculate the net cost of the payments they made, and to misleading and inaccurate statements in the settlement notice about class members’ rights to object, appear at the hearing, or appeal final approval of the settlement.

“A $40 million settlement may sound very positive, but the devil is very much in the details,” said Gina Alongi, Administrator of IUOE Local 4 Health and Welfare Fund. “The way the settlement is currently structured will prevent many health plans and union benefit funds like ours from getting any real compensation from it.”

The three union funds objecting to the settlement are all members of Prescription Access Litigation (PAL), a national coalition of more than 130 unions and consumer advocacy groups that works to challenge illegal practices by the pharmaceutical industry.

“TPPs will have to comb through mountains of medical records and bury themselves in paperwork before they ever see a penny from this settlement,” said Alex Sugerman-Brozan, director of PAL. “Class action settlements are only as good as their claims process, and this one fails at a very fundamental level.”

Last year, Prescription Access Litigation objected to an earlier Paxil class action settlement (Hoorman et. al. v. SmithKline Beecham). That $63M settlement was of a class action brought on behalf of consumers who paid for Paxil prescriptions for children and adolescents. As a result of that objection, important changes protecting consumers’ rights were made to the settlement.

A settlement of a class action must be approved by the Court where the case is brought. Because class actions affect the rights of people and entities that aren’t even aware of the lawsuit, the Court reviews settlements to make sure they are “fair, reasonable and adequate.” Members of the class may object to the settlement, and request to speak at a hearing before the Court.

The case is Carpenters and Joiners Welfare Fund et. al. v. SmithKline Beecham Corp. (U.S. District Court for Minnesota, Case #04-CV-3500). The Final Approval hearing in the case is scheduled for September 30, 2008 in the U.S. District Court in Minneapolis, Minnesota. The deadline for third party payors to submit claims for payment from the settlement is December 12, 2008. More information about the settlement, including claims forms, can be found at www.pediatricpaxiltppsettlement.com. A full copy of the funds’ objection to the settlement can be found at www.prescriptionaccess.org/docs/pediatric-paxil-objection.pdf

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About AFSCME District Council 37 Health & Security Plan
AFSCME District Council 37 Health & Security Plan is a union benefit fund that provides supplemental health and welfare benefits, including a prescription drug benefit, to over 300,000 individuals, consisting of active municipal employees, their spouses and dependants, as well as retirees, who work or worked for New York City, the New York State Court System, various authorities, cultural institutions and the NYC Health and Hospital Corporation.

About Sergeants Benevolent Association Health and Welfare Fund
Sergeants Benevolent Association Health and Welfare Fund provides supplemental health and welfare benefits, including a prescription drug benefit, to 10,000 active and retired sergeants of the New York City Police Department.

About IUOE Local 4 Health and Welfare Fund
IUOE (International Union of Operating Engineers) Local 4 Health and Welfare Fund provides a health and welfare plan, including a prescription drug benefit, to 10,000 covered members of IUOE Local 4 and their families. IUOE Local 4 represents heavy equipment operators, apprentices, mechanics, surveyors, equipment house employees, as well as waste water technician and some public sector employees in Eastern Massachusetts, Eastern New Hampshire and Maine.

About Prescription Access Litigation
Prescription Access Litigation (PAL) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL, a project of the national nonprofit health care advocacy group Community Catalyst, works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. PAL members have filed more than 30 lawsuits targeting such practices. News about PAL’s cases and public education efforts is published regularly on the PAL Blog.

We’ve often gotten on the soapbox here at the Prescription Access Litigation blog to preach against the evils of preemption. Preemption is the constitutional doctrine that when state law and federal law are in conflict, the federal law trumps or “preempts” state law.

Pharmaceutical companies and the FDA have been arguing aggressively in the past few years that consumers should not be allowed to sue drug companies under state law when they are harmed, injured or killed by defective or dangerous drugs, as long as those drugs have been approved by the FDA. For years, the FDA’s position was the lawsuits under state law did not interfere with the FDA’s regulation of drug safety. But that position changed abruptly under the current administration.

The issue has been a hot one – the Supreme Court recently decided (in Riegel v. Medtronic) that consumers’ lawsuits against medical device manufacturers are preempted. In October, the Supreme Court will hear arguments in Wyeth v. Levine, and will decide whether consumers’ cases against drug companies are also preempted.

Yesterday, the House Committee on Oversight and Government Reform, chaired by the indefatigable Rep. Henry Waxman (D-CA), held a hearing on preemption, “Hearing on Whether FDA Regulation Should Bar Liability Claims.” (One mainstream media story on the hearing, from the Associated Press, can be found here).

The hearing had numerous noteworthy and learned people presenting testimony, but most of them were not the source of the press attention that is certainly unusual for an issue as arcane as federal preemption. It was actor Dennis Quaid, who testified, who was the source of the sudden press interest in this arguably vital but obscure constitutional debate.

Dennis Quaid testified because his newborn twins nearly died when they were given 1,000 times the correct dose of the blood thinner heparin. The overdose was the result of a mixup, caused by the fact that the labels of the vial for the correct dose and the vial for the dose that is 1,000 times higher are virtually indistinguishable. Quaid and his wife have sued the manufacturer, Baxter. He testified against limiting consumers ability to file lawsuits to hold drug companies accountable for the kind of harm that his newborn twins suffered.

We blog about this here today because Mr. Quaid’s testimony is so harrowing and so underscores the need to protect consumers’ access to the Courts. Rather than offer our own commentary on this subject, we’ll let Mr. Quaid’s testimony speak for itself. We repost here in its entirety. (You can also find links to the other panelists that testified here, on the Committee’s website.)

Here is Dennis and Kimberly Quaid’s written testimony:

Testimony of Dennis Quaid and Kimberly Quaid Before the Committee on Oversight and Government Reform of the United States House of Representatives May 14, 2008

Chairman Waxman and Members of the Committee:

Thank you for inviting my wife, Kimberly, and me here today to share our experience as parents of two infants harmed by the negligence of a prescription drug manufacturer. As I’ll explain, our newborn twins nearly died because of a drug company’s failure to put safety first. It is our hope that these proceedings will raise public awareness of the issue before the Committee today: When the U.S. Food and Drug Administration (FDA) approves the sale of pharmaceutical drugs, does that preempt the right of consumers to sue the manufacturer if the drug later causes injury or death?

This is an issue, I’m sure, most Americans are not aware of, but it is one that could adversely affect all Americans, our family included. As many of you already know, our twins received a potentially fatal overdose of the bloodthinning medication Heparin last year.

Our Life-Altering Story

Thomas Boone and Zoë Grace Quaid were born on November 8, 2007.

They were four weeks premature, but healthy and beautiful, and, after three days in the hospital, we took them home to begin our new life as a happy, much-expanded family.

On their eleventh day of life, Kimberly noticed an irritation on T-Boone’s belly button and Zoë Grace’s finger. Being nervous new parents, we took TBoone and Zoë to the pediatrician immediately, and, after examining them, he sent us to Cedars-Sinai Medical Center – one of the top hospitals in Los Angeles – for a more in-depth diagnosis. Lab tests at Cedars revealed that both of our twins had a staph infection, and we were told that they would have to be admitted to the hospital to be put on a continuous intravenous drip of antibiotics. Our hearts sank as we accompanied the twins to the pediatric ward, where they were placed in a room to begin their treatment.

At about 11:00 am the next day, a nurse came to the room and said she needed to replace the now empty bags of antibiotic. According to standard procedure, the nurse was supposed to clean the IV lines connected to our twins’ little arms with 10 units of a blood thinner medication called Hep- Lock, the idea being that the very small dose of heparin contained in Hep- Lock allows the IV to flow freely. What was not standard procedure was that she mistakenly injected the twins with a massive overdose of 10,000 units of the drug Heparin, which is 1,000 times the normal 10-unit dose of Hep-Lock our babies should have received. This happened while Kimberly and I were present in the room.

Unaware of the catastrophe that had just occurred, Kimberly and I spent the afternoon and early evening standing vigil over our twins until our doctor suggested we go home and get some rest. We were exhausted, not having slept the night before. The twins seemed to be resting comfortably, so we decided to go home, but not before leaving express instructions to the doctors and nurses to call us if anything changed in our infants’ condition. We had no way of knowing at that point that the potentially lethal quantity of Heparin in their tiny bodies was turning their blood to the consistency of water.

After we left, a nurse on duty noticed that Zoë Grace had an abnormal seepage of blood coming from a place on her foot where blood had been drawn. No alarms were raised. Incredibly, sometime after 7:00 pm, both babies were injected with yet another 10,000-unit overdose of Heparin. One nurse prepared the medication, and then handed it to the instructor nurse, who then handed it to the nurse in training as the instructor lectured the trainee on how infants must only receive a 10-unit dose of Hep-Lock. They then left the room and continued their rounds.

At about 9:00 pm, Kimberly and I were at home trying to get some restless sleep when Kimberly was suddenly struck with a hammer blow of overwhelming dread. She became inconsolable, crying out with a mother’s intuitive certainty that our babies were in trouble: “They’re passing,” she said. This did not make sense to me. I had called the nurse’s station an hour and a half earlier and had been told that the twins were fine. But, to calm Kimberly’s fear, I called again and was put through to the nurse in our room. Kimberly wrote down the time for some reason. The nurse told me in a measured tone that the twins were fine. I was assured. Kimberly became less frantic, and we both eventually fell into a fitful sleep.

But the twins were not fine. In fact, they were fighting for their lives. Their now water-thin blood was flowing out of every place that they had been poked or prodded. They faced the very real possibility of hemorrhaging through a vein or artery, causing massive brain damage or failure of one of their vital organs.

Our babies could have died that night, and we would not have been there for them.

Early the next morning, Kimberly and I arrived at the hospital, only to be met at our babies’ room by our pediatrician and hospital staff. We were taken aside and told what had happened. Suffice it to say, it was the beginning of the most frightening day of our lives. It was spent helping tend to our infants who were still bleeding profusely and severely bruised from internal bleeding. They were both screaming in pain, and God only knows what they were feeling. I am not sure even a lab rat had ever received such a high dose of the Heparin that was causing them to bleed out. At one point as the doctors tried to clamp shut a bleeding wound in the remnant of TBoone’s umbilical cord, blood spurted six feet across the room and splattered on the wall. The bleeding went on all day. Although the twins had been administered Protamine, a medication to counteract the Heparin overdose, their blood’s inability to coagulate literally remained off the charts all day and into the night. Kimberly and I did a lot of praying.

Finally, after more than forty hours, their coagulation levels dropped into the measurable scale and continued to fall, eventually back into the normal range. T-Boone and Zoë Grace had survived, apparently with no damage so far, thank goodness. But we have no way of knowing what the long-term effects may be.

We Were Not Alone

How had this happened? The answer became apparent after interviewing the doctors and nurses. We discovered that the bottle of 10-units of Hep-Lock and the 10,000-unit bottle of Heparin – both manufactured by Baxter Healthcare Corporation – were deadly similar in labeling and size. The 10,000-unit label is dark blue, and the 10-unit bottle is light blue. And if the bottles are rotated slightly, as they often are when stored, they are virtually indistinguishable.

We later learned that the similarity of the labels for the two products had led to the overdose of infants at a hospital in Indianapolis little more than a year earlier, in September 2006. Just like with T-Boone and Zoë Grace, hospital staff used the 10,000-unit Heparin product, rather than the 10-unit Hep- Lock, to flush the infants’ IV lines. Tragically, three infants died, and three others were severely injured.

More than four months after the Indianapolis incident, Baxter sent out a warning to hospitals concerning the potential for deadly mix-ups in the two products. A full seven months after that – in August 2007 – Baxter submitted changes in the labeling of the higher-concentration Heparin to the FDA. Baxter was permitted by FDA regulations to revise its labels, without prior FDA approval, to add or strengthen a drug warning or precaution, or to enhance drug safety by strengthening an instruction about a drug’s dosage and administration. So, although the FDA did not approve the changes to the Heparin label until December 2007, Baxter starting using its new labels in October 2007. Baxter described the changes to the Heparin labels as “an increase of 20 percent font size, a unique color combination, and a large cautionary tear-off label” warning that the product is not intended for “lockflush.”

Baxter explained that the new labeling was designed to help reduce the risk of medication errors. But, shockingly, Baxter failed to recall the misleadingly labeled bottles that were still on the market and stocked in hospitals ready for use. Kimberly and I think that this was a dangerous, potentially deadly decision, made by Baxter for financial reasons. Companies recall automobiles, they recall toasters, they even recall dog food, but Baxter failed to recall a medication that, due to its labeling, had killed three infants and severely injured three others. More than a year after the Indianapolis tragedy, the same medical nightmare happened to our twelve-day-old infants – and all because Baxter had not acted as a responsible corporate citizen.

Baxter knew that an estimated 7,000 Americans die each year as a result of medication errors, knew that 61 percent of life threatening or lethal errors involve intravenous drugs such as Heparin, and also knew that Heparin was among eight high-alert products that were involved in more than 31 percent of all medication errors that caused harm to patients. Yet, even with all of this knowledge, Baxter did not change the labeling of its Heparin injection products until months after the Indianapolis tragedy. And Thomas Boone and Zoë Grace would have to fight for their lives because the new product labeling, introduced by Baxter only one month before, had not yet made it to the shelves of Cedars-Sinai, and Baxter had done nothing to see that the look-alike Heparin products were removed from pharmacy shelves immediately.

Although mistakes occurred at Cedars-Sinai hospital, doctors, nurses, pharmacists, or other staff who make medical errors are not bad people. Indeed, choosing a career devoted to curing the sick and easing the suffering of others is one of life’s highest callings. But the overdosing of our twins was the result of a chain of events, and the first link in that chain was Baxter Healthcare. Because of Baxter’s inaction, a tragedy was waiting to happen again.

What Can Be Done?

Since this brush with tragedy, I have found out that medication errors are unfortunately all too common. Approximately 100,000 U.S. patients die every year because of medical errors in hospitals alone. It’s a toll we would never tolerate in aviation, nearly the equivalent of a full 747 crashing every single day.

I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people.

For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.

Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.

We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.

It is hard for me to imagine that this is what Congress intended. You tell me, Mr. Chairman: When it passed the Food, Drug, and Cosmetic Act in 1938, did Congress intend to give appointed bureaucrats at the FDA the right to protect a drug company from liability, even when the company cuts corners and jeopardizes our safety?

A federal ban on lawsuits against drug companies would not just deny victims compensation for the harm they experience. It would also relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered – years after their drugs are on the market.

Permitting bureaucrats who are under pressure from their bosses and the drug companies themselves to yank our access to the courts is incomprehensible. We have all heard about understaffing and backlogs at the FDA, and about drug-safety scrutiny that is patchy at best. If the Supreme Court rules in favor of the drug companies, it will eliminate one of the most effective deterrents to letting the bottom line win out over public health and safety.

I am in the entertainment industry, but what happened to us, and what is happening in the courts of our country, is no fiction. It is all too real. That is why I have decided to speak out and try to do something.

Kimberly and I have established a non-profit foundation to call attention to medical safety issues and seek ways to improve medical safety from the bedside up. Everybody gains from a safer health care system—from patients to nurses and doctors to hospitals and insurance companies.

We are meeting with experts from all over the country to formulate a strategy for safer health care. Americans pioneered the safest aviation system in the world; though highly complex, it is 99.9% error free. The human body is also very complex and hard to perfect. But we should strive for perfection, and we know that at the very least we can do much better. We can hope that the Supreme Court will not put more barriers in front of patients who are harmed by drug companies. But if the Court goes along with the FDA and rules for the drug companies, I respectfully ask this Congress to pass corrective legislation on an emergency basis, just as it should do immediately to correct the recent Supreme Court decision immunizing the makers of defective and mislabled medical devices. We Americans need some balance on the scales of justice in our country.

My family blessedly survived a huge drug error, triggered by the misconduct of a drug manufacturer. Others are not so fortunate. If they are denied access to our courts, they will have no compensation for their injuries, and society will lose one of the most effective incentives for safer drugs.

Today the FDA is holding a hearing on over-the-counter cough medicines marketed for use in children under 6. Our colleagues at the Prescription Project have issued a new report, Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children. The reports documents that the industry spends more than $50 million a year marketing cough medicines for children under 6, despite the lack of evidence that such drugs are effective for such children, and evidence that the drugs can present serious risks.
See coverage of this issue, and of the industry’s recent preemptive recall of a number of these medications approved for use in children 2 and under, here.

We here at the Prescription Access Litigation blog often lament the explosion of advertising for prescription drugs. But the huge spending on marketing of Over-the-Counter remedies is also troublesome. Over-the-Counter remedies are supposed to be safe enough for patients to take without a physician’s supervision. The disclosures that Over-the-Counter drugs have to make are, thus, much less than for prescription drugs. This lulls people into a false sense of security that if a drug is Over-the-Counter, it must be completely safe. Widespread marketing of these drugs only increases that impression. And marketing such drugs for use in children uses this belief to offer harried parents a quick fix for their children’s symptoms.

At the root of many of the problems caused by drug advertising, whether prescription or over-the-counter, is the shift in recent decades to thinking about medicines not as medical treatment but as a consumer product. But as we here are fond of saying — drugs are not like fabric softener or shampoo, and we treat like as such at our peril.

The FDA recently announced that it will hold a hearing on November 14, to consider whether to make certain drugs available only “behind the counter” — that is, without a prescription but only dispensed by a pharmacist. Presumably, this would introduce the intervention and consultation of a pharmacist, who could ask the patient questions to determine if the drug was really appropriate and advise them of alternatives if it was not. Many other countries have numerous drugs “behind the counter” that are Over-the-Counter in U.S. While we here at PAL don’t have a position on this proposed new status for drugs, it does seem that these cough medicines would be a good candidate if this status were created.

Below is the Prescription Project’s press release on the report, which you can find here.

The Prescription Project Report Shows Industry Spends $50 Million-a-Year Marketing Cough and Cold Medicines for Children Despite Evidence of Risks

Report says lack of results, risks for children under six does not deter drug company marketing of these products as “safe and effective.”

BOSTON–(BUSINESS WIRE)–The Prescription Project today released a report showing that companies producing over-the-counter (OTC) cough and cold medicines spent more than $50 million marketing these widely used products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children. The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Federal Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.

The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, shows a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. Manufacturers have heavily marketed this class of OTC preparations for many years based on their FDA classification as “safe and effective,” yet the FDA has not conducted or brought forward a single study or review to prove the safety or effectiveness of these products for use in small children in the last three decades. The full report is available at www.prescriptionproject.org.

“Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” said John Santa, MD, MPH, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project (DERP). “In this case, it appears the benefits are close to zero while the risks are significant.”

Last week, in response to growing questions and pressure from pediatricians and the FDA, major manufacturers of the popular cold remedies announced that they were voluntarily withdrawing from the shelves OTC infant cold and cough products marketed for children age 2 and under. As of yet, there has been no action on drugs marketed for children 2-6 years old.

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and seeks to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit www.prescriptionproject.org.

The New York Times ran an excellent op-ed on Sept 21, “Shy on Drugs,” by Christopher Lane. Professor Lane takes psychiatrists to task for too readily diagnosing shy children as having “social anxiety disorder.” He pins a chunk of the blame on the Diagnostic and Statistical Manual of Mental Disorders (“DSM” for short), the diagnostic bible of the psychiatric profession:

[A] glance at the manual reveals that the diagnostic criteria for shyness are far from clear. The third edition, which was published in 1980, said that a person could receive a diagnosis of what was then called “social phobia” if he was afraid of eating alone in restaurants, avoided public restrooms or was concerned about hand-trembling when writing checks.

The same guidelines could hardly apply to youngsters heading to kindergarten, children not yet potty-trained and toddlers just learning to eat. So in 1987, the revised third edition of the manual expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.

The definition of this “disorder” then sets the stage for wholesale manipulation by pharmaceutical companies all too eager to offer up a pharmaceutical solution:

Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline [NYSE:GSK], the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (“Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone…social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent — higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.

In 2005, we gave one of our Bitter Pill Awards to GlaxoSmithKline for its marketing of Paxil, the Cure For the Human Condition Award. We pointed in particular to this fact:

In June [2005], the FDA issued a warning letter to GlaxoSmithKline for its “Hello, My Name is.” television ad campaign for Paxil. The FDA said that this ad wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR” when these are simply not approved uses of the drug. Despite the warning letter, the harm had already been done as millions of consumers had already seen the ad.

This type of marketing, and the widespread diagnosing of shy children (and adults) as having a medical disorder as opposed to run of the mill shyness, is often cited as an example of “disease mongering.” It’s a symptom of a larger problem — the medicalization of an ever-increasing portion of the spectrum of normal human behavior. Anything that deviates from some pharmaceutically-determined median is now a candidate for an expensive, brand-name drug, from how shy we are to whether or not we occasionally can’t sleep to whether our legs twitch when we sit still to whether we have toenail fungus.

The prescribing of expensive, strong and often dangerous prescription drugs to ever growing numbers of children with shyness is ironically happening at the same time that an also every growing numbers of children are being prescribed expensive, strong and often dangerous prescription drugs for Attention Deficit Hyperactivity Disorder (ADHD). Children generally are being prescribed more and more prescription drugs, even when such drugs have often not been tested on or approved for children. (We reported on another example recently: “Doctors widely prescribing drugs for kids’ sleep problems”)

There are no doubt some children who benefit from SSRIs such as Paxil and drugs for ADHD, for whom the benefits outweigh the often considerable risks. But they are undoubtedly a fraction of those children who are prescribed these drugs. We as a society are turning too quickly to the pharmacist for a solution to complex issues. Shyness, inability to pay attention, hyperactivity — these are not merely — or often even primarily, if at all — medical or biochemical issues. They’re affected by a broad range of factors, such as class size, nutrition, sleep, the quality of housing and one’s environment, the stability of home and family life, etc. It’s far easier to write a prescription than to tackle these larger problems. But the underlying problems will remain. Pharmaceutical companies are all too willing to pitch their solution, regardless of the harm it causes or whether it actually addresses any underlying problem.

WebMD reported last week on a new study in the journal Sleep. The study found that doctors are widely prescribing sleeping pills and other drugs to children having sleep problems. An astonishing 81% of the 18.6 million doctor visits studied included a prescription being written. By contrast:

They found that diet and nutritional counseling were advised for 7% of children and that 22% were prescribed behavioral therapy such as psychotherapy and stress management to relieve the sleep problems. For 19% of children, both behavioral therapy and medication were advised.

The data studied only go til 2004. Advertising for sleep drugs has exploded since 2004. Both Lunesta and Rozerem were introduced after that time, and have been extremely heavily advertised. Ambien CR was also widely advertised in that time period, both to compete against these new drugs, and to get patients to switch from Ambien to Ambien CR before generic versions of Ambien came on the market. (In 2006, we gave one of our coveted Bitter Pill Awards to the makers of both Lunesta and Ambien/Ambien CR – the “The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who’s ever had a Bad Night’s Sleep”) It is likely that the enormous promotion of prescription sleep aids in the past 2 and 1/2 years has increased the number of kids being prescribed drugs for sleep even more.

Several things about these findings are disturbing:

• It suggests that doctors are rushing to medications, and not adequately addressing underlying causes, or emphasizing behavioral changes and “sleep hygiene.”
• Many of the drugs being prescribed have not been tested on children, and are not FDA-approved for use in children — this is so-called “off-label” usage. While off-label prescribing is quite common (one study found that 1 in 7 prescriptions was for an off-label use), it is potentially more troubling when it is done for children. Children are not “little adults” — it cannot be assumed that a drug will work the same, or that side effects and risks will be similar for children as they are for adults. The effects of drugs on children’s growth and development is unclear if the drug has not been studied in children and is not approved for use in children.
• It exposes children to the risk of addiction or dependency. Many drugs used for sleep problems have these risks, even those that are not specifically approved for insomnia.
• It introduces children at an early age to the dangerous idea that there is a pill for all their problems, and that taking prescription drugs is “no big deal,” and just a routine part of everyday life. This cultural attitude has contributed to the extremely troublesome and widespread trend of teenagers and young adults misusing and abusing prescription drugs.

For some children, the use of a prescription drug may be the appropriate route for addressing a sleep problem. Insomnia and other sleep problems can and do interfere with children’s growth, learning and behavior, and need to be addressed. But it is a sad commentary that millions of children are being prescribed prescription drugs, when for many of them, changes in diet, routine and schedule would work just as well and not expose them to the risks, known and unknown, that come with these prescription drugs.

The Sleep study can be found here.

Postscript:
In a bit of irony, the article on WebMd was bordered on two sides by an ad for Rozerem. See screen shot below: