Let's Call the Whole Thing Off

Psychiatric Times
By Irwin Feinberg, MD
May27, 2010
Dr Feinberg is Professor of Psychiatry at the University of California at Davis

A vital consideration we learn in medicine is that continuing life support for a moribund patient past a certain point is harmful to the lives of all concerned. We have reached that point with DSM5. Dr Allen Frances has outlined compelling clinical arguments against many of the new disorders DSM5 proposes and he has shown how their adoption could have far-reaching, unintended, and damaging consequences for the patients we have pledged not to harm, and for society generally.

I write from the vantage point of 50 years of psychobiological research. Most of it is in the field of sleep neuroscience. However, as often happens in science, one thing leads to another and my observations enabled me to propose that the human brain undergoes a profound reorganization during adolescence driven by synaptic pruning and that some cases of schizophrenia might be caused by errors in this process.1 My association at NIMH with Edward V. Evarts, one of the great neurophysiologists of the last half century, stimulated me to propose that the hallucinations of schizophrenia result from a failure of feed-forward mechanisms that distinguish self-initiated neural activity from that produced by external stimulation, resulting in auditory hallucinations and other first-rank symptoms.

It is difficult and time-consuming to produce reliable new knowledge; it cannot be accomplished by committee fiat, as Drs Kupfer, Schatzberg and Regier seem to be believe. Dr Frances has mentioned the damage to psychiatric research that several new, ill-conceived categories in DSM5 could inflict. He also pointed out that changing nomenclature and diagnostic standards in the absence of compelling scientific justification will severely damage psychiatric research as well as clinical practice. Many of these changes would make it impossible to compare decades of epidemiological results with new findings. Moreover, the sloppy thinking and language in the proposed revision will be apparent to any educated layman. The “field trials” and timetables proposed for new categories are laughable to any statistically trained psychologist. The inevitable public exposure of the gross defects in DSM5 will bring our entire field into disrepute and diminish public support for the research we need.

There have been no research advances that demand new diagnoses and syndromes. Despite many intriguing findings, no psychiatric disease can be diagnosed by a biological or psychological test. If the DSM5 committee believes that new genetic or imaging findings justify a revised nomenclature, they should indicate which ones. Instead of creating dangerous new categories, let us discontinue DSM5 development and use its funding to make strong bridges between DSM-IV and ICD 11. We should also work to diminish or eliminate the huge differences between the US and the UK in the incidence of diagnoses like ADHD and pediatric bipolar disorders. These differences make it impossible to compare cross-national biological research on the same diagnostic categories, even in countries with similar cultures and medical traditions.

The proposed DSM5 would be a giant step backwards for psychiatry. American psychiatrists should petition the APA to drop this ill-conceived and badly executed project.

Drug Company to Pay Half a Billion Dollar Fine for ILLEGAL Marketing

Mercola.com
The World's #1 Free Natural Health Newsletter
May 20, 2010

Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.

The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.

The New York Times reports that:

"AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug's risks. "

Sources:
New York Times April 26, 2010
The United States Department of Justice April 27, 2010


Dr. Mercola's Comments:

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The illegal and unsafe actions of drug companies make headlines yet again as AstraZeneca agrees to pay a $502 million fine to settle the federal charges of using illegal marketing tactics to drive up sales of its blockbuster drug Seroquel.

Although this sounds like a lot of money, it's little more than a symbolic slap on the wrist when you consider how much money they've made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!

You see from the company's perspective it's merely another cost of doing business. For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

How Did Potent Antipsychotics Become the Top Selling Drug Category in US?

Amazingly, and something that not even I had realized until this article was being written, is that this class of antipsychotics has now surpassed cholesterol-lowering drugs as the top-selling category of drugs in the US!

This fact, in and of itself, should be a red flag that something has gone seriously awry, because no nation could possibly have that many psychotic residents.

And that's just... We don't.

Using illegal marketing tactics to promote the use of Seroquel and other drugs like it has greatly expanded the sale of these types of drugs for far less serious, and at times completely unrelated, ailments.

Making matters even worse, they've also been heavily promoted for seniors and children - groups in which this drug can be far more dangerous.

Seroquel has been found to cause rapid weight gain and diabetes, for example. And seniors with dementia are at a higher risk of death when taking this drug. These are just a couple of reasons why Seroquel has been unable to gain FDA approval for certain uses. And yet, AstraZeneca, like so many other drug companies, chose to put profits before safety and health once again.

Puny Fines after Making Massive Illegal Profits Seem to Be the Norm

Just last month I discussed the case of Pfizer, the world's largest pharmaceutical company, that was "punished" with a fine that amounted to three month's worth of profit for the illegal marketing of the painkiller Bextra.

In 2005, when Bextra was pulled from the market due to its increased risks of heart attack and stroke, about half of its $1.7 billion in profits that year were due to unapproved off-label uses.

There's no doubt that Seroquel's blockbuster status and massive sales are in large part due to dangerous off-label uses as well.

Seroquel was approved by the FDA in September 1997 for "the treatment of manifestations of psychotic disorders."

Three years, later, the FDA actually considered NARROWING its approval to the short term treatment of schizophrenia only. However, by January, 2004, the drug was approved for the short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania), and two years later, they also approved it for bipolar depression.

Schizophrenia and bipolar disorder are serious mental disorders that in many cases may warrant drug treatment, at least short term. However, AstraZeneca also pushed Seroquel for things like anger management, ADHD, Alzheimer's disease, and even difficulty sleeping!

No federal criminal charges have been filed against the company, but I wonder if that wouldn't be justified. After all, they're promoting a potent drug for diseases that they were never formally studied or approved for.Without this important proof of safety and effectiveness, they have put countless human lives at risk for serious side effects, including premature death.

How is this NOT a crime?

But wait, of course no criminal charges will be filed because, just like Wall Street bankers, these companies are "too big to fail". What a load of horse manure, pardon my language. Nevertheless, that is what happens when your profits are so large you can afford to lobby and payoff the right people in government, to effectively insulate you from any prosecution.

Yes these companies are VERY clever.

Off-Label Use of Drugs Increase Your Risk of Harmful Side Effects

While doctors can legally prescribe FDA-approved medications off-label for any use, drugmakers are not allowed to market them for anything other than approved uses.

Many physicians, however, for all intents and purposes rely nearly exclusively on drug reps to educate them about the indications for drugs and what other leading physicians are using them for, and drug companies are not shy about suggesting off-label uses.

As demonstrated by this recent rash of lawsuits, drugmakers actually go several steps further, by fraudulently manipulating doctors into prescribing their drugs for ailments that they could not gain approval for in the first place.

Complicating matters further is the fact that it can be difficult for physicians to determine what certain medications are approved for, based on the Summary of Product Characteristics (SPC) -- the information given to physicians about drugs.

In fact, according to a 2009 study, it was impossible for physicians to determine the licensing status for about 20 percent of drug... which means it's even more likely they'll rely on drug reps' opinions and suggestions.

Off-label drug use is actually extremely common, for drugs of all kinds.

According to studies conducted in Britain, when a "suitable alternative" did not exist, doctors used unlicensed or "off label" medicine in:

* 90 percent of babies in neonatal intensive care units
* 70 percent of children in pediatric intensive care units
* Two-thirds of children on general medical and surgical pediatric wards in the UK

According to two of the studies, children taking these medicines face a higher risk of side effects, with one estimate suggesting they suffer up to three times more side effects as a result.

This is why it's so important that drug companies refrain from these illegal marketing tactics, because doctors mislead by their pharmaceutical reps are literally putting their patients' lives at risk!

As Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania stated:

"People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In the end that's all it is... Promoting drugs for off-label uses has nothing to do with trying to help more people. It's all about making more money off a drug that has a limited market.

The Dangerous Side Effects of Seroquel

It's hard to believe that anyone would agree to take such a potent antipsychotic unless they were suffering from a serious mental illness, but the numbers prove that plenty of people do.

This choice can be a devastating one. (And remember, it IS a choice. Your doctor cannot force you to take any drug, and in many cases, people see an ad on TV and voluntarily ask for the drug.)

The potential side effects of taking Seroquel are numerous, and some of them can be fatal.

For example, elderly patients who have lost touch with reality as a result of dementia are at an increased risk of death, which is why Seroquel is not approved for this use.

Seroquel can also increase your risk of suicidal thoughts and actions, especially in children, teens and young adults.

It's worth noting that the list of serious side effects is far longer - and these reactions are FAR MORE COMMON - than the list of the non-life threatening adverse reactions.

For example, some of the most common side effects of Seroquel include:

* High triglycerides in 23 percent of patients
* Weight gain in 23 percent of patients
* Agitation in 20 percent of patients
* High cholesterol in 17 percent of patients

Meanwhile, mild side effects like nausea, congestion and stomach pain are far less common, occurring in only two to ten percent of patients.

Be One Less Victim

Fortunately, you can avoid becoming the next victim by taking control of your health. This means educating yourself about your condition, any symptoms you may have, the drugs your doctor recommends, and other alternatives.

I can't stress this enough: You are NOT REQUIRED to take a drug recommended by your doctor.

You ARE allowed to demand detailed answers to any questions you have about the drug prescribed to you, and if you decide that the risks are greater than the potential benefit, you can "just say no," and seek out alternatives.

Remember, this is your life, and your health, so take an active role in it!. If your doctor pressures you to take it, remember that there are other doctors out there and it is probably best to find someone else who will actually LISTEN to you.

Leading a healthy lifestyle and staying educated about drug-free and non-invasive treatment options are the keys to your long-term well-being.

It's unfortunate, but many are still completely unaware of the pervasive corruption that exists within the field of pharmaceuticals. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.

Drug companies have accumulated so much wealth, power and political influence that they're able to escape any serious consequences linking them to profiting from permanently disabling, crippling or even killing consumers. This is why it's so imperative you make your own informed decisions rather than blindly trusting the system.

Physicians must also, en masse, come to the realization that drug reps cannot be trusted. This may be one of the most difficult areas to change, as the pharmaceutical industry has devised a highly effective system of indoctrination and very specific psychological techniques to manipulate physicians.

Doctors usually believe they are immune to persuasion tactics, and drug reps know just how important it is to maintain that illusion -- which is why it works so well. However, the idea that reps provide a valuable, informative service to physicians is total fiction, created and perpetuated by the drug industry, to keep this deadly, but profitable, scheme going.

Until real change takes place, I urge you to not risk your money or your life on a paradigm designed to profit from your ill health.

Instead, take control by adopting natural lifestyle strategies that will promote your body's natural healing abilities without the need for the drug companies' latest creations.

Child Abuse, Review doctor's work again

Boston Globe
Editorial
May 3, 2010

IF THE medical care given to 4-year-old Rebecca Riley appears appropriate to the state panel that oversees doctors, that panel needs to take a new look at the case.

Rebecca was the victim of one of the most appalling child abuse cases in recent memory; in December 2006, she died on her parents’ bedroom floor of an overdose of powerful psychotropic drugs. They had been prescribed by Dr. Kiyoko Kifuji, a child psychiatrist at Tufts Medical Center, who relayed details of her treatment on the witness stand during the murder trials of Rebecca’s parents. Kifuji’s testimony — given under immunity — was so disturbing and seemingly cavalier that Plymouth District Attorney Timothy Cruz has asked the state Board of Registration of Medicine to reopen its review of her license. “If what Dr. Kifuji did in this case is the acceptable standard of care for children in Massachusetts,’’ Cruz said, “then there is something very wrong in this state.’’ He’s right.

The issue of acceptable medical care is separate from the question of responsibility for Rebecca Riley’s death. (Rebecca’s parents were both convicted of murder.) A grand jury declined to indict Kifuji for manslaughter, though a wrongful death civil suit against her is pending. After a full review, the state Board of Registration of Medicine allowed her to resume seeing patients last fall. The board’s proceedings are kept private, but in typical cases, it reviews medical records and hears testimony from experts in the field. In Kifuji’s case, the panel likely heard defenses of the controversial practice of giving powerful psychotropic drugs to small children.

It’s not the board’s role to arbitrate among different schools of thought within a medical field. But even if one grants that medication — when prescribed responsibly and monitored closely — can help children with extreme and dangerous symptoms, Kifuji’s actions remain highly questionable. She diagnosed Rebecca with bipolar disorder and attention deficit hyperactivity disorder based largely on her mother’s description, sometimes during brief visits when Rebecca was asleep. She kept prescribing medication even when Rebecca’s mother increased the dosage to unauthorized levels. Kifuji also refilled prescriptions more than once when the mother said she had lost the pills. The doctor disregarded concerns raised by a family friend, pharmacists, a therapist, and a preschool nurse who complained that the child was as limp as “a floppy doll.’’

Parental observations are critical in child psychiatric cases, and the parents of young patients shouldn’t be presumed dishonest or dangerous from the start. But a responsible clinician — especially one trained to examine behavioral nuances — should be able to detect when a parent is malicious or untrustworthy. In the case of the Rileys, the signs were numerous and extreme.

Doctors have a legal obligation to report child abuse. By extension, their treatment of children should come with particular vigilance and caution. The medical board should reopen Kifuji’s case to determine whether she truly did everything she could to prevent the death. If anything positive can come from Rebecca Riley’s short, miserable, tragic life, it’s an affirmation that, when it comes to treating the state’s youngest, most vulnerable patients, doctors should be held to the highest of standards.

© Copyright 2010 Globe Newspaper Company.