Monday, April 21, 2008

Whistleblowing 101

I hate that word "whistleblowing". However here is a rapid pictorial guide to asking questions while preserving your sanity.



Lesson 1: Ignore those many institutions whose sole apparent remit is to hide problems on behalf of powerful friends. It is not the best of times for institutions that have claimed the right to uphold standards of integrity in medicine. In the UK, the General Medical Council (GMC), the Medicines and Healthcare Products Regulatory Authority (MHRA), the UK Panel for Research Integrity and Public Concern at Work are examples of organizations that are having trouble working out what they are for. Just state the obvious and let the obfuscators obfuscate.

As Groucho Marx said of the MHRA and research fraud:
"Either it is dead or my watch has stopped".
Or as George Orwell said of the General Medical Council:
"We have now sunk to a depth where the restatement of the obvious is the first duty of intelligent men".
How about this as a statement of the obvious: "Research fraud is not generally a good thing in medicine".

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4 comments:

soulful sepulcher said...

i have not worn a watch for 2 years when it stopped as i left the state institution building, which holds more information than the state and pharma wants ppl to know. my watch reads 5:32pm and is dead on the table, same as all of this shit/.

Anonymous said...

I don't like the word 'whistleblower' either, but thats a word that we all understand.

Its not so bad a word really:

"Origins of the term whistleblower

The term whistleblower derives from the practice of English bobbies who would blow their whistle when they noticed the commission of a crime. The blowing of the whistle would alert both law enforcement officers and the general public of danger.
"

(http://www.answers.com/topic/whistleblower?cat=biz-fin )

You and other 'whistleblowers' DO alert the general public of danger, and thats always a good thing to be doing so don't let the term worry you.

Anonymous said...

Crime and Punishment: Enough for Corporate Wrongdoing?

Corporate crime should not be a new concept to many. However, it has evolved into more troubling ways- not only in regards to its severity, but the methods of deterrence now being implemented against corporations. So it may be becoming progressively worse for U.S. citizens as a result.

Rather than speak of all corporations, what will be discussed is government health care fraud. Fraud basically is deception with the potential to harm others. In the case of pharma companies, this may include improper promotion and marketing, meaning that such tactics are or may be deceptive misconduct that may be illegal. In addition, there are the crimes of kickbacks and lesser crimes of misbranding products. Probably more methods of wrongdoing as well do in fact exist and happen. Yet the point is that drug companies should not engage in such wrongdoing to enrich their faceless existence with profiting off those who are ill in illegal ways.

How is such conduct discovered? Typically by whistleblowers who worked for the described pharma company, and such people are rare for a number of reasons. The whistleblower then seeks legal agents and files what is called a qui tam false claims act with a district attorney’s office (Boston or Philadelphia, if you want prosecutors to take you seriously). After the case is filed, the whistleblower verbally acknowledges the charges and evidence to the chosen prosecutors and others.
Such cases usually take years for unclear reasons, yet in the past two years, the settlements from such cases has approached 2 billion dollars after investigations ended that took years, which is tax dollars returned to the American public with these settlements.
So, what has been happening once a pharma company is busted. Criminal indictment by the district prosecutor? Hardly, yet appropriate. Usually, the prosecutor’s objective is to dismiss the case, but give the impression that such activities will not be tolerated by our government. So Corporate Integrity Agreements are mandated to the pharma company, but not really taken seriously, as some have more than one of these agreements active still. It’s an invisible ankle bracelet. A pharma company can and have committed equal or worse crimes while under such an agreement. This Agreement is issued after the deferred or non prosecution agreement is sentenced to the law-breaking corporation, which basically is a pre-trial diversion. Essentialy, it’s just parole, which is supported by the DOJ and the administration. The criminals admit wrongdoing, but not guilt. And they pay a settlement in the neighborhood of hundreds of millions of dollars. Not that shocking, if you consider the income of big pharma companies. These agreements are relatively new and partially a result of suggestions from what was known as a Thompson memo, which basically was created by a DOJ guy as commandments for prosecuting corporations and variables to consider when doing so, which ultimately offered responses as to why a greater degree of punishment was not enforced.

We are one of three countries in the world with the most prisoners behind bars, yet those that do similar if not greater harm to others get out of jail free. Double standard, I would say. Is this behavior by our legal system towards corporations an effective deterrent? Most think not. It rather seems like tacit approval of their conduct. And health care fraud may be more damaging than other types in other industries, yet lack of regulation allows such crimes to continue.
Citizens should make the laws in our country. Justice would then finally exist. Yet this is clearly a utopic fantasy of mine.

“Corporations cannot commit treason, nor be outlawed, nor excommunicated, for they have no souls.”
---- Edward Coke

Dan Abshear

Anonymous said...

The Damage of Legalized Lying

Amazingly, with the pharmaceutical industry, the amount spent by them on marketing is far greater than the amount spent on research and innovation, as it approaches 30 billion annually spent on their marketing efforts, as this presently takes priority over the research and development, so it seems. This includes 5 billion that is spent on drug reps, who implement the tactics of their marketing departments.

Marketing in some form exists with every business regardless of the industry of the business and its purpose. Essentially, marketing in itself is a complex activity- consisting of many specialty elements of various areas and levels, typically of an aggressive nature. However, with the pharmaceutical industry, marketing needs to become more specialized and altered due to the delicate nature of health care in order to prevent harm and ensure quality health care for all. Tactics that ignore such caution and consideration possibly could cause harm to patients in a number of ways, as this occurs presently. And recently, the marketing exposure of the drug industry has become an unfortunate issue for this industry for many reasons that remain a reality aside from what drug PR firms may try and tell us, as presently it seems as if the pharmaceutical industry, once viewed as very ethical, are now viewed as motivated by profit and greed. Such unwise and irresponsible methods include:

1. Advertising directly to the consumer. This method of bypassing what should entirely be decided by the heath care provider, as disregarding the determining factor of the heath care provider can possibly lead to inappropriate prescribing of certain advertised meds due to the demands of an unqualified patient who believed the content of such an advertisement that suggests that they are a candidate for a particular drug involved in the advertisement. Furthermore, it potentially removes the discretion of the provider regarding the best treatment for the patient through such frequent methods of marketing to potential consumers by such advertisements directly to consumers. Assessment of a patient by a health care provider is required and necessary, most believe, in order to determine the best treatment for a patient, as well as the provider considering their medical history as well as other variables necessary to consider the best course of the patient’s treatment. Ignoring this premise could be damaging to the patient seeking treatment through this possible inaccuracies through efforts provided by the marketing departments of drug companies.
2. Clinical evidence is the ultimate determining factor for treatment selection, after drug sample availability, and this evidence should be utilized by the provider entirely absent of any marketing technique implemented by a drug maker, which may include embellishments and lack of necessary evaluation of such patients. Analysis of such evidence is very necessary for the ultimate benefit of the patient.
3. People take issue with the use of celebrities who are paid greatly by some drug companies, possibly to attempt to expand or create a certain medical condition, so the celebrity will discuss a certain disease state determined by who paid such a celebrity. Many examples of this occurring have been noted by others, and can lead to both inappropriate prescribing and over-prescribing of these meds so often promoted to consumers. This may be appropriate if one is attempting to sell a car, but health care is more of an important topic of concern.
4. Education not only trough sponsored doctors of the drug company, but also statements from various medical groups sponsored as well by the industry for purposes of endorsement have been considered inappropriate for the welfare of public health through awareness techniques such as these methods initiated by marketing departments lacking thorough clinical evaluation that is necessarily for the best treatment of patients seeking care or concern of their health. As an ex seasoned big pharma drug rep, I can assure you that education is not the purpose of a pharmaceutical company.
5. The over-saturation of drug company sales reps who in the past have initiated questionable tactics upon the direction of their marketing department of their drug company employer, regardless of the validity or legality of such tactics that are normally not questioned or known by the drug reps in the first place. Such forms of manipulation include for some time questionable inducements for the health care providers. This is allowed to happen regardless of whether or not it is legal. As a result, many medical establishments are progressively prohibiting the activity or presence of drug reps at their locations. With the pharmaceutical company, sales reps are required by their employers to follow the direction of their marketing departments without exception. And the questioning of these directives is not tolerated by their employers. Because of this, the drug company’s image becomes more damaged as a result. To further illustrate this drug rep description, their employers require them to spend huge amounts of money annually to spend for doctors or to doctors that is void of any benefit for the patients.
In the past, the pharmaceutical industry was viewed as research-driven, innovative, and patient focused- entirely for the benefit of patient heath. This is why the industry was at a time viewed as an ethical one. Clearly, this is not the case today. Instead, many view this industry as one with their primary goal is to initiate market-driven profiteering, regardless of the attempts of the industry to convince the public otherwise, as stated previously by the industry’s supporters, who have attempted to place value to the medical community as the goal of the pharmaceutical company. So the view by the public of drug companies has been damaging to what should be a concerning degree because of their tactics and deception. So the pharma industry seems to be in great need of repair and re-evaluation of their purpose. This should performed by action instead of empty statements by the industry. It is the author’s opinion that actions by this industry for the sole benefit for the patients are displaced if they exist, unless my interpretation and perception are flawed greatly. The repair can only be done by the refocus of the industry towards convincing the public of the industry’s concern of their restoration of the patient’s health in several ways. One way is to always make the medical community aware and with conviction that their products are solely for the benefit of the patients, which is rarely discussed in full detail with such people. Fortunately, medications historically have been for this reason and are often necessary for the restoration or benefit of the health of those in medical need. The need should be more clearly defined by those who determine this, and these are the health care providers, who are caregivers, and not marketers. In summary, the medicines now available to us are for the benefit of the patients, and not the developers.

“Marketing is the act of making something seem better than it really is” --- Suso Banderas

Dan Abshear
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