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« The Integrative Health Care Solution -- A 2-Part Series | Main | Pharmaceutical News by Press Release? (OR: Low Dose Naltrexone Study Doesn't Make the News) »

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Dan

This Makes Me Sick


When I heard the word 'war-monger', I had to find out its 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 directed at others whoever said these two words. So I felt a need to know what these words, and how they affected others who heard them.

Finally, I found the answer: a warmonger is one who promotes war, which is undesirable or discreditable. In this case, one labeled this would have an affinity for what others are reasonably opposed to share the same views:

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

Please review the link above, as there appears to be with some in the pharmaceutical corporate world that are offended by being labeled disease mongers. Often, others are offended by facts that exist as a reaction, it seems. Clearly, disease mongering is real, and activities illustrate this behavior.

Disease mongering is when a large pharmaceutical corporation implements various unethical if not illegal activities in order to sell more of their products by either creating or expanding a particular illness. They do this by creating the perception that others are ill when, in fact, they are not.

Drug companies do this by seeking more of those who should be patients in need of treatment with the drug maker's promoted medications, regardless if they are in need of such treatment or not, clinically.

How this is done by these companies will be described soon.

The drug makers clearly place the needs for their drugs to be for medical conditions whose treatment regimens are to be viewed by others as incomplete or unmet. The companies want to let the public know of the progressive increase for the disease states and how their products treat this illness better than what is available now or has been used in the past. How ironic it seems that drug companies, who make drugs to delay the progression of, or cure diseases with these drugs, wish for others to become as sick as possible to profit from their suffering that they create with disease mongering and sell more pills.

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 in several ways the delivery of fabricated if not baseless information during this process. Usually, the pharmaceutical either creates or expands a disease state by deception directly to consumers, often. Then the consumer, who now believes that they are ill, go see their health care provider. The health care provider, due largely to the unfamiliarity of the patient’s symptoms expressed by the patient, if not the drug the patient is requesting, usually writes a prescription for the drug requested by the patient.


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 that exist, possibly. The disease monger strives to inflate the volume of a disease for which they have drugs to treat for their own financial gain.

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 may not exist, yet again, the greater number of people convinced they are afflicted with a certain medical disorder, the better it is for the drug company. What the drug company implements to make sure this happens includes the following:

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, involve leading questions often- created by the drug company. It was around this time that the United States was becoming more of a psychotropic nation.

These screenings that involve the leading questions responded by select groups of people. They are asked these questions by certain disease state support groups who have been converted into front groups after being funded by those big pharma companies who produce drugs for particular 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 absent before this wonder drug entered his system. 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 approves 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. Drug companies that make medications to treat this disease are more than happy to support the financial needs involved in creating these guidelines. Dyslipidemia, for example:

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. Same with cholesterol screenings that occur often.

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 many, and these companies do this for profit and profit only.

I worked for three of the largest pharmaceutical companies in the world for over a decade, and the disease mongering protocols were similar if not identical with all of these companies,

Dan Abshear



.

Dan

The Fallacies Associated With ‘Me-Too’ Pharmaceuticals
“But corruption is neither need based nor greed based. It’s simply opportunity based.” -----Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.

It has been said by others that the pharmaceutical industry should not have government regulation or interference from anyone interfering with their autonomy- because that would drastically limit if not eliminate their progressive innovation regarding the restoration of the health of others with their drugs.
Also what has been stated by this industry that their internal controls prevent wrongdoing, so there is no need o be under surveillance. So, according to some, the public’s health would be potentially unfulfilled and possibly harmed without the copious innovative products of this industry. As with other issues we face as citizens, this is another attempt by an industry that is constantly attempting to integrate fabricated fear in our minds- void of any proof or reason, and this is a fallacy.
As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall, those innovators and lifesavers of the past.
Over the last several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement. Of all drugs approved by the FDA, few offer any clear clinical advantages over other drugs for certain patients. The approved drugs, called new chemical entities, that have been FDA approved lately which were developed by drug companies, possess microscopic therapeutic advantages over existing drugs that are presently prescribed for particular patients.
This inefficient drug development process by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased, ‘me too’ drugs.
These drugs essentially are small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project. That’s why you have a half a dozen statins or ARBs available to you. The are all equivalent, biochemically.
This ‘me too’ objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a pending drug awaiting approval to only be slightly superior to a placebo, the copies of drugs that already exist are approved by the FDA.
While unnecessary, these me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market or disease state, which means the drug company who develops a me too drug hopes to eventually make over 1 billion dollars a year on such a drug, at least. For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. While unnecessary for the health of others, this is where the research dollars are going with those in the pharmaceutical company.
As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected. They create clinical trials to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class both during and after the creation of these me too drugs. Yet again, if they are in the same therapeutic class, they are all essentially the same regarding efficacy and safety.
Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.
Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, some me too drugs occasionally are beneficial for patients for some reason or another, but should absolutely not be a primary objective of the drug companies to create them as often as they do.
Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry presently. It appears that, thanks to the Bayh-Dole Act of 1980 in the United States, the pharmaceutical industry is allowed to license newly created synthetic small molecules from those in the academic world, and then proceed with development of another’s creation that the pharmaceutical company will claim as their innovation to the public.
Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is greatly demonstrated with other industries and is the apex of business operations in the United States.
This pharmaceutical industry model is an exception to typical business operations, and the reason for this remains an unknown, as far as the etiology of those who take their drugs being deprived of expected cost reduction in this costly environment of drug spending. So a drug company comes out with a me too drug, and claims it is unique rather deceptively, so there is no cost advantage for the consumer.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely created for their own profit, clearly illustrates their focus on their avoidance of true research and discovery for the sake of their own profit viewed by them as of being of greater importance.
Innovation, along with ethics, use to define this pharmaceutical industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods for the public health. Perhaps more cures and more therapeutic options would be available if the objectives of the pharmaceutical industry were for the benefit of the health of others.
Hopefully, such historical qualities of drug companies will return some time, in time.
“Most people are other people. Their thoughts are someone else’s opinions, their lives a mimicry, their passions a quotation.” --- Oscar Wilde
Dan Abshear
Author’s note: What has been written was based on information and belief.


Dan

The Atrophy Of Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list of corruptive tactics by the pharmaceutical industry that sponsors such trials. By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public.
Most would agree that the science of research should be sound and as aseptic as possible- completely free of deliberate and reckless interference. However, it appears, money and increased profits can be a catalyst for disregard for human health with the clinical trial process that is largely unregulated.
This is particularly a factor on post-marketing studies of various pharmaceutical companies, as some pharmaceutical corporations seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors. Trials that are in fact pointless and void of scientific benefit.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past.
Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research to a degree.
This resulted in the creation of for-profit research trial sites without any academic affiliation that are called Contract Research Organizations. CROS utilize primarily community patient care clinics whose staff are absent of any research training compared with the former researchers that existed decades ago. Because of this structure, the clinical trial investigators of these pharmaceutical sponsored trials are likely novice compared with academic researchers.
This, of course, happens with intent by the sponsor who can and does control all aspects of the clinical trial protocol at the site locations of a clinical trial that the pharmaceutical company structures and even gives the trial the title they want for their marketing purposes.
These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this protocol of the sponsor ensures favorable results of the sponsor’s medication that is involved in the clinical trial they clearly own.
These activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit the pharmaceutical sponsor. There likely is a collusive relationship between the sites, the CRO, and the sponsor, as this whole system is planned beforehand by the pharmaceutical sponsor of their clinical trial to again be utilized to increase the market share of the drug studied that they promote.
Guest authorship has been known to be aggressively recruited by sponsors by paying a known opinion leader to sign off on the completed clinical trial. Furthermore, the pharmaceutical sponsor recruits investigators to be used for this function of what ultimately is a fabricated clinical trial protocol. The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor on how this should be prepared.
The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company and also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug company’s hired CRO editors whose objectives are to benefit the sponsor. Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO and the recruited ghostwriters exceeds 1000 dollars per page, some have said.
Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits. Apparently, this is no longer the case. There are other well known and large pharmaceutical corporations that consider this plan of action standard operating procedures to ensure growth of their drugs.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known again as ghostwriters. These people are usually not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers.
One does not need research training or certification in order to perform this function. Rarely do clinical trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the pharmaceutical sponsor. Also, these hired mystery writers are known to make about 100 grand a year performing this deception full time.
This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring again a known thought leader as an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked or required by the hired author, others have said.
To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of pharmaceuticals that are studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks as a result of this process.

The purchased reprints of the fabricated clinical trial are then bought by the sponsor of the study from the medical journal they hired to publish this trial. The reprints are eventually distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation that has happened with such a trial that benefits the drug they promote for their employer. As a bonus, the sponsor may agree to pay the chosen medical journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with drugs that are claimed to have benefits that are absent have now become unreliable in large part due to such corruptive situations. Not to mention the absence of objectivity that has been intentionally eliminated with trials produced in this way.
More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA. We as citizens need to dig deep and ask why this is happening.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement from the maker of the drug studied in a clinical trial.
And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health.
Knowledge is power, and is also possibly a lifesaver.
“Ethics and Science need to shake hands.” ……. Richard Cabot
Dan Abshear
Author’s note: What has been written was based upon information and belief.

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