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Greg Pawelski

The shift, almost 20 years ago, from the institution-based, inpatient setting to community-based, ambulatory sites for treating the majority of the nation's cancer patients has prompted in large part additional costs to the government and Medicare beneficiaries. The Chemotherapy Drug Concession gave oncologists the financial incentive to select certain forms of chemotherapy over others because they receive higher reimbursement.

Typically, doctors give patients prescriptions for drugs that are then filled at pharmacies. But medical oncologists bought chemotherapy drugs themselves, often at prices discounted by drug manufacturers trying to sell more of their products and then administer them intravenously to patients in their offices. Not only does the oncologist have complete logistical, administrative, marketing and financial control of the process, they also control the "knowledge" of the process. The result is that the oncologist selects the product, selects the vendor, decides the markup, conceals details of the transaction to the degree they wish, and delivers the product on their own terms including time, place and modality.

There was a joint Michigan/Harvard study authored by Drs. Joseph Newhouse and Craig C. Earle, entitled "Does reimbursement influence chemotherapy treatment for cancer patients?" It confirmed that medical oncologists choosed cancer chemotherapy based on how much money the chemotherapy earns the medical oncologist.

The authors documented a clear association between reimbursement to oncologists for the chemotherapy and the regimens which oncologists select for their cancer patients. In other words, oncologists tended to base their treatment decisions on which regimen provided the greatest financial remuneration to the oncologist.

The study adds to the 'smoking gun' survey by Dr. Neil Love, entitled "Patterns of Care." One of the results of this survey shows that for first line chemotherapy of metastatic breast cancer, 84-88% of the academic center-based oncologists (who do not derive personal profit from infusion chemotherapy) prescribed an oral dose drug (capecitabine), while only 13% prescribed infusion drugs, and none of them prescribed the expensive, highly remunerative drug docetaxel.

In contrast, among the community-based oncologists (who do derive personal profit from infusion chemotherapy), only 18% prescribed the oral dose drug (capecitabine), while 75% prescribed infusion drugs, and 29% prescribed the expensive, highly remunerative drug docetaxel.

While the Michigan/Harvard study showed results before the new Medicare reform, the Patterns of Care study showed results that the Medicare reforms are still not working. It is still an impossible conflict of interest.

And the existence of this profit motive in drug selection has been one of the major factors working against the individualization of cancer chemotherapy based on testing the cancer biology.

Two scientific studies giving us a dose of reality that once a decision to give chemotherapy is taken, oncologists receiving more-generous Medicare reimbursements used more-costly treatment regimens.

It's not that all oncologists are bad people. It's just that it is still an impossible conflict of interest (i.e. it's the SYSTEM which is rotten). Some oncologists prescribe chemotherapy drugs with equal efficacies and toxicities. I would imagine that some are influenced by the whole state of affairs, possibly without even entirely admitting it. There are so many ways for humans to rationalize their behavior. The solution is not to put the doctors in jail; it's to change the system.

Sources:

http://content.healthaffairs.org/cgi/content/abstract/25/2/437

http://patternsofcare.com/2005/1/editor.htm (figure 37, volume 2, issue 1, 2005)

Dan

The Conversion of Our Protector

Not long ago, what we as American citizens ingested in ourselves may have been at times dangerous due to flaws in the process of producing food and drugs in particular. With the absence of regulation of the manufacturers, American citizens could not be assured in what they may take to eat or restore their health was safe for them, and this was understandably concerning for many people.
Nearly 100 years ago, one man changed the fears and concerns of American Citizens regarding what they may eat, or what medicine they may be given to restore their health. And this man simply improved the way things were by writing a book.
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume. The administration was created to regulate the manufacturers who make items people do consume to ensure the safety of the American citizens.
The man responsible for the development of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book he wrote several decades ago, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. Called, “The Jungle” The one particular issue in his book regarding the lack of food safety is what caught the attention of the public who read his book, and this included the U.S. president. The impact caused by this book on others is what led to the development of the FDA.
However, and with great disappointment, the purpose and function of the FDA seems to have changed in the past few decades. The FDA appears to have decided to ensure the health of the pharmaceutical industry, an industry the FDA was designed to regulate. This is one of many disturbing flaws and concerns expressed by others regarding the FDA.
One example is the large amounts of money the pharmaceutical industry gives the FDA for various reasons created recently. These amounts of money are so large that this money given to the FDA accounts for nearly half of the FDA’s entire budget. An example of stated reason by the FDA for receiving such funds is due to what is known as the PDUFA ( the prescription drug user fee act), which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their medications awaiting approval by the FDA. The FDA also accepts from this industry over a million dollars from certain drug companies in order to give their pending new drugs a priority review of 6 months instead of a year, along with a creating an etiology for this urgency as it happens, others have said.
Results of this relationship, which some have called collusive and pathologically intimate between the FDA and the drug industry, may have something to do with the actual removal of newly approved drugs due to safety reasons. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns, one could safely say.
The FDA and the drug industry continues to attempt to validate and explain often what many others have questioned about the FDA and its lack of focus on the safety of the public- the public the FDA is suppose to protect to assure their safety. Yet the focus of the FDA and the purpose of their creation appears to be absent.
The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA announced they were allowing the pharmaceutical industry to allow their promoters of their branded drugs they market to discuss these products for disease states not studied or evaluated by the FDA. This process use to be mandatory before a drug company could claim that their drugs were beneficial for a particular disease state. Many remained shocked on this decision made by the FDA.
Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of the public health, allows for potential dangers associated with this practice. This autonomy of the FDA illustrates once again the present state of the FDA and its need for reform.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, and they do so based upon their own discretion. Historically, a pharmaceutical drug promoter was legally forbidden to suggest to a health care provider to use their promoted drugs for disease states not approved by the FDA already.
In fact, it was a federal offense for such drug representatives to speak off-label about the drugs they promoted for their employers. In the past, drug companies have had to pay settlements to the DOJ when they fractured these laws regarding off label promotion of medications.
This off-label FDA protocol for drug representatives that has been allowed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.” This overt and absurd benefit for the pharmaceutical industry is that now they can have their pharmaceutical sales representatives, unregulated themselves, speak about their promoted medications to health care providers essentially in any way they choose.
Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss the complex considerations a health care provider is able to do because of their training.
Most drug representatives have little medical or clinical training in any objective way, and they are not hired with having such a background, usually. So this seems to further complicate the idea of this off-label authorization by the FDA due to the ignorance of the representatives to discuss such clinical matters. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to further embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them. In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of the typical pharmaceutical sales representatives that now exist. This study also concluded that around 80 percent of health care providers prefer not to interact with pharmaceutical representatives, yet still accept drug samples from them for their patients. The results are rather understandable considering what we now know.
So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association with the pharmaceutical industry by suggesting such practices that aggravate the existing situation with the lack of protection that was once offered and required from the FDA.
It is unbelievable this good reprint practices ever came into existence- with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate if not increase existing patient medication errors, such as in the elderly or dosing for children.
So there are enough problems with prescribing, and adding this FDA seems to be making the issues with medications in the U.S. worse instead of better. We as citizens are no longer the concern of the FDA, one could safely conclude, and this is clearly dangerous to the health of the public.
Perhaps another alternative would be to have clinically trained people discuss such issues regarding the benefits of medications with prescribers, instead of existing drug reps who have the sole objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part, or the consequences of their actions as they promote their drugs in this way. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain drug was initially indicated for upon approval. Yet this should not be determined by those who promote such drugs. Now, unfortunately, pharmaceutical representatives are allowed to determine how they can promote their drugs for their employer’s benefit.
Regardless, awareness needs to happen by the citizens involving these tactics progressively allowed by the FDA that are dangerous and deceptive to the health of the public. As citizens, we have the right to insist that the FDA- our FDA- maintains focus on the safety of the public and their health. Reform of the FDA appears to be necessary for this to occur to re-establish the FDA as the administration that was created for our protection, and not to protect others financially.
About half of all drugs approved presently by the FDA have had serious post-approval side effects that should have already been known or suspected of these drugs. Well over 100 thousand people die every year from drug reactions or mistakes. This seems to be a rather significant concern for those who are need to restore their health.
Dan Abshear

Dan

This Makes Me Sick

When I heard the word 'war-monger', I had to find out it’s definition, as I had no idea what that word meant. I knew others could be labeled this word, as I had heard it in the past infrequently, so I wanted to find out what it meant.

Finally, I found the answer: a warmonger is one who promotes something that is undesirable or discreditable. In this case, one labeled this would promote war.

http://collections.plos.org/plosmedicine/diseasemongering-2006.php

Please review the link above, as there appears to be with some…. an uncertainty of the existence of disease mongering.

Disease-mongering is when typically a large pharmaceutical corporation implements various illegal activities in order to sell more of their products.

They do this by creating more of those who may be patients in need of treatment with the drug maker's promoted medications, regardless if they are in need of such treatment or not.

How they do this will be explained soon. The drug makers clearly want the needs for their drugs to be for medical conditions whose needs are unmet. The companies want to let the public know of the progressive increase for the disease states for which their products treat better than what is available now or has been in the past.

This disease-mongering in fact does occur often to widen the diagnostic boundaries of an illness, disorder, or syndrome by creating awareness of such medical conditions to the public- utilizing fabricated if not baseless information during this process.

First, let's take a look at this label of disease mongering. It is inappropriate in that, unlike diseases and illnesses, mongering occurs with medical disorders and syndromes as well. It is accurate and factual, however, that disease mongering does occur, but is not limited to diseases only. How about medical mongering?

Mongering is the process of a dealer who promotes something previously void of credit or desire by others, such as illness, in order to create need by patients who are not in reality.

There was a book written by Ray Moynihan and Allan Cassels called, "Selling Sickness" in 2005. The book thoroughly described how big pharmaceutical corporations are turning all of us into patients.

Disease mongering progressively continues to create patients with illnesses, disorders, or syndromes that in fact do not exist. This is due to, you guessed it, Big pharmaceutical corporations engages in this in number of ways:

1. Paying medical journals to publish fabricated clinical trials involving their promoted medications after paying those involved with such a clinical trial to create such fabricated data. That is disease mongering to the health care provider.

2. Subjective screenings, such as those for various mood disorders. These screenings, as well as the affective disorders, which were rare until about 1995. That is also about the same time when the U.S. became a psychotropic nation.

Screenings involving leading questions conducted by disease state support groups converted into front groups after being funded by those big pharma companies who produce drugs for these mood disorders.

3. Disease creations I: Social Anxiety Disorder, or social phobia: This condition is in the DSM IV which was published in 1994, and some were forced to delete the statement regarding this disorder that said, "Social Anxiety Disorder is not well-established, and requires further study."

Aside from what may be simply amplified introversion, social phobias are likely due to societal dysfunctions and certainly should not be labeled as a pathological condition requiring pharmacological treatment.

4. Disease creations II: Premenstrual dysphoric disorder. I call this a mid-life crisis, yet it was entered by instruction by the APA (American Psychiatric Association) into the DSM (the psychiatrist's bible) in 1993. Anxiety about the inevitable does not require pharmacological treatment.

5. Direct to Consumer Advertising:. Most memorable were those commercials for erectile dysfunction. Their absurdness in creating these commercials appears to have multiple psychotic components:

A healthy man who could probably run a marathon is having a decent time with his wife at some upper middle class location. He is smiling all the time. Because now, his marriage is secure due to his ability to copulate- which was apparently void before this wonder drug. Of course, it is not possible to have a happy marriage without intercourse, right?

Then there are other conditions which are entirely natural in the human lifespan, yet have been determined to be diseases by those who can profit off of these lifespan events. Examples include osteoporosis and menopause, as well as erectile dysfunction. It’s insane the FDA approve pharmaceuticals for these natural events that occur normally in a human being.

Finally, there are the required medical guidelines for various disease states, such as dyslipidemia.

Publications such as the Lipid Letter, and Lipid Management, both offered more aggressive management of the lipid profiles of the patients of the readers. And both publications were funded completely by those big pharma companies that promote statins.

A myth is something unproven. A false belief, or invented story.

Disease Mongering is not a myth. Large pharmaceutical corporations promote illness and disease- not desired by anyone and discredited by most, and they do so for profit. This claim I will continue to make, as the claim comes from one who did in fact pay several associations to expand the markets for our products more than I care to admit for 10 years. I was a disease monger by direction,

Dan Abshear



.

Dan

The 'keeping tabs on doctors' by drug companies is called "Data Mining". The American Medical Association sells to those in the pharmaceutical industry identification information on its members. As a result, the drug companies can detect trends in prescribing, and who they should reward, as well as disregard.

The AMA makes about 50 million dollars a year on this side business of theirs that very few are aware of, unfortunately.

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