Monday, June 9, 2008

Medical Research - Follow the Money

The use of psychiatric drugs in children has exploded over the past ten years. Powerful new medications for the treatment of attention deficit disorder and bipolar disorder have emerged on the market and we are now learning that three prominent researchers from Harvard have been paid millions by the pharmaceutical industry to promote these drugs for use.

University researchers are supposed to self-disclose consulting and speaker monies they are paid by pharmaceutical companies. They are required to supply conflict of interest forms but it appears they can write anything they want on them and there is little oversight. It has now come out that these physicians under reported their earnings by...are you ready for this....
Dr. Joseph Biederman -$1.6 million, Dr. Timothy Wilens - $1.6 million, Dr. Thomas Spencer - over $1million.

No wonder they wanted to hide it. They had lots to be ashamed of! When prominent and influential physicians publish articles and speak around the world at medical meetings, they are supposed to be completely free of bias. When the National Institute of Health (NIH) hands out taxpayers money for medical research, it is a huge conflict of interest for those same researchers to be paid from the company whose product is being studied.

This type of consultant pay is all too common in the medical world and we owe thanks to Sen. Charles Grassley (R-Iowa) for pushing this into the limelight.

Harvard's Mass General Hospital administered these grants and won $287 million grants in 2005. They didn't push too hard for self disclosure and there is a lot of hand washing and spin control going on, now that the truth has been dragged into the light.

To quote from the New York Times, "In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen."

For the multi-billion dollar drug industry, those millions given to the "Doctor Pitchmen" was money well spent.


Dr. Know said...

You are right on Dr. Toni. This is highly unethical behavior and other bloggers have tried to say it might just be an "innocent error". Just because someone has a Harvard degree doesn't mean they are immune to
greed. I am sure they justified taking the money and felt they were doing right by saying "Lilly sponsored this program" but the true deception came out when they failed to fully disclose the $Millions they were paid. When you leave off a few zeros, that is willful and shamefull.

Anonymous said...

I wonder if they got any penalty or fine, and if it affects their license for their unethical deception? Makes me wonder how anyone can know which studies and research are valid and ethical. Thanks for pointing out that prominmnt and influential physicians don't always have integrity and ethics.

Rich said...

This is an outrage. follow the money is right - the same goes for the price of oil,,,just follow the money.

Beastarzmom said...

Great graphic.

Healtnut said...

It is NOT an innocent error. It's the norm. Most CME classes are sponsored by the pharmaceutical industry, so it should not be a surprise.

Besides, aren't some primary care doctors still accepting free vacations from those "sleazy" pharmaceutical reps? We don't see them disclosing this info to their patients either.

I know how you feel. It's very frustrating when you see "crooks" get ahead. The best way is to tell people the truth. The more I know about some doctors, the more I wish they will go bankrupt soon, so they do less harm.

Anonymous said...

With bipolar, no child should be diagnosed with this disorder, as its occurence is rare:

Bipolar Disorder (manic-depressive illness) has been defined as a major affective mood disorder in which one alternates between the mental states of deep and brutal depression and embellished elation. These mental states can last for months in some bipolar disorder patients. These cyclical episodes are a catalyst for noticeable psychosocial impairment. Also, the episodes of both manic phases as well as depressive ones can last anywhere from weeks to months.
Bipolar Disorder also affect’s one’s cognition, emotions, perceptions, and behavior- along with psychosomatic presentations (such as pain with depressive episodes, for example). It is thought to be due to a physiological dysfunctional brain in one affected with bipolar by many. Yet Bipolar allows for exceptional abilities when a bipolar person is in their manic phase at times (
The etiology for bipolar disorder is unknown. As many as half of those suspected as having a bipolar are thought to have at least one parent with some sort of mood disorder similar to bipolar disorder, which suggests a genetic predisposition may be present. Because of the complexity associated with bipolar disorder, greater than 50 percent of those afflicted are misdiagnosed as major depression, or perhaps schizophrenia.
It is also believed that bipolar presents itself with symptoms associated with the definition of bipolar when one is between the ages of 15 and 25 years old. The disorder was entered in the psychiatrists’ bible, the DSM, in 1980, although bipolar disorder is thought to have existed for quite some time.
Also, those with bipolar are thought to be in possession of heightened creativity during their manic phases, as well as they have accelerated growth of their neurons. This is not necessarily a bad thing, it seems. Conversely, those with bipolar disorder experience up to 3 times the number of depressive episodes as manic ones.
Research has determined that as many as 15 to over 30 percent of bipolar patients commit suicide if they are left untreated, or undertreated. Also, as many as half of those affected with bipolar also have at times severe substance abuse issues along with their bipolar as well. Co-morbid medical conditions should be taken into consideration when evaluating one suspect of, or having bipolar disorder.
Bipolar patients are also often experiencing anxiety issues that vary, and are treated often as a result of these medical issues. The disorder varies as far as severity goes- with some bipolar patients being more severely affected than others. In fact, there are at least 6 classifications of bipolar, according to the DSM.
Bipolar patients are thought to be symptomatic half of their lives. As stated previously, the depressive episodes occur more frequently than manic ones. When symptomatic, bipolar patients are thought to be rather disabled, according to some, when in their depressive state in particular. The diagnosis has become more frequent recently. In one decade, the assigned diagnosis of bipolar rose from being about 25 per 100 thousand people to being 1000 per 100,000 people.
Most diagnosed with bipolar are not diagnosed based on solid, comprehensive, or psychiatric review that is often absent of valid or standard diagnostic methods. Some believe as many as 5 percent of the human population may be affected by bipolar disorder- which may include as many as 12 million people in the United States. This is if the diagnostic criteria developed by others were to be fully utilized. An emphasis should be implemented by the health care provider to utilize available clinical evidence, and review this scientific literature.
A subjective questionnaire called the Mental Status Examination is often utilized when diagnosing one suspected has having bipolar disorder. Many believe the diagnosis has increased recently due to the progressive treatment options now available. It is an argument of increased awareness versus over-diagnosis.
Yet the diagnosis is vague, as children and adolescents are often absent in research with bipolar. Also, there is not any objective diagnostic testing to rely upon for bipolar. There is also a mental diagnosis of what is called mixed depressive disorder, which is one with depression who also has minimal manic episodes.
Many younger than 18 years of age are prescribed atypical anti-psychotics as first line treatment, which is largely not recommended as treatment options. In fact, close to half a million of those younger than 18 years of age are prescribed the atypical anti-psychotic Risperdal alone, it has been determined. The class of medications overall is thought to be prescribed to about 10 percent of those non-adults thought to have bipolar.
While not recommended, about a half of all those assessed as being bipolar are prescribed antidepressants, such as SSRIs, as first line treatment. It has been suggested that this class of drugs has decreased the risk of suicide attempts compared with other classes of antidepressants for close to 20 years.
Yet tricyclic antidepressants have been determined to be efficacious in over half of those diagnosed with bipolar - with a greater amount of research behind this class of drugs. Furthermore, therapy with any antidepressants has been associated with what is known as treatment-emergent mania. This is when a bipolar disorder that is in a depressive state rapidly enters a manic phase. This occurrence can be unmanageable by the bipolar disorder patient.
The most recognized treatments for bipolar long term are lithium (Ekalith or Lamictal- along with an anti-convulsant. Sugar intake is thought to vex the symptoms of one with a bipolar disorder as well.
Atypical anti-psychotics have been prescribed for bipolar, which change some aspects of the brain, physiologically, as does the disease itself. In fact, one may argue the brain becomes more efficient due to both the disorder and the treatment with the atypical anti-psychotics. Yet many recommend the utilization of this class of drugs with bipolar disorder only if psychosis is present as well.
As many as 15 percent of bipolar disorder patients diagnosed as such are prescribed an atypical presently. This class of medications may be particularly beneficial for those women who are diagnosed with bipolar who are pregnant, however.
Lithium, which is essentially a very light metal with low density in which the salts are obtained for medicinal treatment, and an anti-convulsant are believed to be standard bipolar treatment, pharmacologically, studies have shown. This is due to Dr. John Cade and his examination with lithium and its benefits with those who have psychotic excitement close to 60 years ago.
Ekalith is believed to be both neuro-protective as well as having an anti-suicidal affect in those believed to be bipolar- and is viewed as a mainstay as far as treatment for bipolar goes with many who treat the disorder. Lithium is thought to regulate the calcium molecule in the brain, so this and valporate are historically the medicinal treatment options preferred for those with bipolar disorder.
Bipolar is difficult to detect, and is often diagnosed as major depression with many affected by this disorder. There is no objective criteria protocol available to utilize when assessing any patient believed to be suffering from any mental disorder. So such mental disorders that are diagnosed are ambiguous, yet that does not conclude that such disorders do not exist, such as the case with bipolar disorder.
Yet perhaps a health care provider should be very thorough and knowledgeable when assessing a patient believed to have a mental condition such as bipolar. As should the health care provider keep in mind that the ultimate goal with this disorder is to stabilize the mood of the one affected.
Dan Abshear
Author’s note: What has been annotated is based upon information and belief.