Dan Abshear – Brain Blogger Health and Science Blog Covering Brain Topics Fri, 01 Feb 2019 16:17:23 +0000 en-US hourly 1 https://wordpress.org/?v=5.0.3 Are Drug Reps Really Necessary? /2008/08/26/are-drug-reps-really-necessary/ /2008/08/26/are-drug-reps-really-necessary/#comments Tue, 26 Aug 2008 19:35:06 +0000 /?p=951 One of the main functions of pharmaceutical representatives is to provide free samples to doctors’ offices instead of what has historically been their vocation: implementing authentic and ethical persuasion via presentations. Yet presently, samples are a priority and delivering them is the primary function for drug reps, and these samples in themselves cost billions to the pharmaceutical industry. Yet arguably, samples are the most influential tool in influencing the prescribing habit of the healthcare provider. Let me be clear on that point: it’s samples, not a representative, as the true catalyst of establishing the prescribing habits of a prescriber.

Yet considering that drug promotion cost, overall, is approaching $20 billion a year, which includes the approximately $5 billion spent on drug reps themselves, what if there is another way for doctors to get free drug samples? What if prescribers could, with great elation, avoid drug reps entirely, yet still receive drug samples for their patients?

MoneyThere is actually a way to do this, but it is a limited process.

With some select, smaller pharmaceutical companies, doctors have the ability to order samples by printing order forms obtained on certain drug company sites on the internet for medications associated with the manufacturers. Examples of such branded medications that can or have be ordered in this way are Keflex, Extendryl, and Allerx. Possibly several more can or are available to prescribers in this way. Others, however, cannot be acquired by this method, yet this method may be the most preferable both from a business and efficiency point of view. Customer satisfaction would clearly be elevated.

So in some situations, a doctor can go online, print off a sample order form, fax it into a designated fax number after completion of the form, and the samples are shipped directly to the doctor’s office. There is no review of the doctor’s prescribing habits nor are there any possible embellishments from reps. And that appears desirable to many health care providers, yet most drug companies apparently place unneeded value on the impact potential of a sales rep of their company to a level of some sort of delusion based on metrics that are possibly categorized as types of fantasies with the copious amounts of drug reps today.

Now, why is this not done more often? Apparently, it is legal. If samples are the number one influencer of prescribing habits, why spend all the money on drug reps to deliver samples personally, as this is essentially their primary duty?

It’s worth exploring, possibly, since the drug rep profession has evolved essentially into those who become a specialized delivery person, dressed in a nice suit, one could say. In other words, and in my opinion as a drug rep, most doctors will not and prefer not to dialogue with you during your visit to their medical clinic.

Think of the money that could be saved if more pharma companies offered samples to doctors in this manner. Furthermore, there is no interruption of the doctor’s practice. And again, there is no risk of bias presented to the doctor.

Doctors again would be able to order and utilize samples according to their discretion, and would be free of interference from the marketing elements of various pharmaceutical corporations. Patients benefit when this occurs, likely. For example, health care providers would be free of possible embellishments and exaggerations voiced by reps on their promoted meds. Inducements would not be offered or accepted. Reciprocity would not be so insisted upon with the absence of drug reps, possibly. In fact, doctors may write more scripts for shipped samples than delivered samples because their discretion is free from interference they have experienced to some degree, and doctors are or would be possibly thankful for this.

Considering the high costs associated with the pharmaceutical industry, having samples shipped directly to doctor’s offices should be utilized more than it is presently — regardless of the size of the pharmaceutical company, perhaps. And the pharmaceutical companies would save quite a bit of money as well without a sales force that may likely not be needed after all. Drug prices may improve.

Something to think about as one ponders cost savings regarding this issue, and improving the efficiency of patient care and treatment.

The new source of power is not money in the hands of a few but information in the hands of many.
— John Naisbitt

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A Television As Your Doctor? /2008/05/19/a-tv-as-you-doctor/ /2008/05/19/a-tv-as-you-doctor/#comments Mon, 19 May 2008 18:37:27 +0000 /?p=943 Drugs and Clinical Trials CategoryWe often see advertisements on television for some type of medication — usually one involved in a large-market disease and the commercial is sponsored by a big pharmaceutical company. This is called direct to consumer (DTC) advertising, and doctors would prefer they did not exist.

Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of these commercials greatly increased. Now, the pharmaceutical industry spends around $5 billion annually on this gigantic media effort. Normally, the commercial airs within a year of the drug’s approval, which raises safety concerns and involves money spent that could be applied to greater uses, according to many. But, we are dealing with a corporation here.

TVThe purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective — to increase sales and grow their market — in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition. The most interesting ones are for erectile dysfunction (ED) during primetime TV, with the real possibility of children watching. Further surreal is that these particular commercials seem to have ED sufferers portrayed as those who could probably run marathons, which is not realistic from a clinical perspective.

DTC advertising is also a catalyst for and similar to disease mongering. Disease mongering is the creation of what some believe to be medical flaws. It is illustrated by the drug companies through exaggeration and embellishments via various media sources as an avenue for propaganda — often seen with DTC advertising. Though the flaws may not be medical, the corporate creation of these questionable human ailments that do not require treatment, possibly, may be an attempt to develop a particular medical condition to acquire profit.

One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. It is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments being advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.

Also, DTC ads normally discuss a single treatment option when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the physician, as they assess your health, not your TV or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of America and New Zealand.

Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professionals remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. After viewing a DTC ad, many seek out a doctor visit and request whatever product that was advertised, which makes the doctor’s situation quite cumbersome. So the doctor and patient relationship is altered in a negative fashion since most DTC advertised drugs require a prescription.

Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some of our over-prescribing habits, which will benefit all of us in the long term. And the health care system can regain control of its purpose, which is far from financial prosperity.

Men of ill judgment oft ignore the good that lies within their hands till they have lost it.

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A Failed Attempt to Improve Perceived Greatness: The ENHANCE Trial /2008/05/10/a-failed-attempt-to-improve-perceived-greatness/ /2008/05/10/a-failed-attempt-to-improve-perceived-greatness/#comments Sat, 10 May 2008 14:47:52 +0000 /?p=936 Drugs and Clinical Trials CategoryWhile it seems that sponsors of clinical trials usually end up with results that clearly favor their medicine, there are rare exceptions. Merck and Schering-Plough proved that with their disappointing ENHANCE Trial which many have heard about through the media.

Vytorin is a combination pill for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor — one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. Several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor as a single therapy. The clinical trial was named the ENHANCE Trial.

Medicine bottleAfter several years passed, the trial sponsors faced disappointment which was first brought to the attention of Schering in March of 2007, however, the results existed since the spring of 2006, I believe. The disappointment is that Vytorin lacked anticipated benefit over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia in 2007, combined with what I believe was about $5 billion in revenue for these two drugs, this was a problem — perhaps for Schering in particular, since over half of their profits and earnings were from these drugs.

Being the responsible corporations both companies are, of course, alterations occurred after such events. The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Although the trial results existed, they were not disclosed at the time of their discovery. After several months of possessing the results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during its course. Since their deliberate concealment was clearly wrong, in response to those who asked if trial manipulation was occurring, Schering stated that continued data analysis from the trial was the etiology for the delay.

With clinical trials, case report forms are used to record data and are created in a manner where further analysis is unnecessary, as such forms are quite clear and not subject to interpretation. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE Trial. An investigation began into the activities of both companies at that point. It became a catalyst for the ENHANCE Trial results to be finally released in the beginning of 2008, which caught the attention of major media organizations.

In the spring of 2008, a very large cardiology meeting was held, where the audience was told to stick with statins due to this trial’s lack of outcomes for Vytorin. Furthermore, a cardiologist at this meeting also suggested that a moratorium occur with the utilization of Vytorin, since statins are much less expensive, and are highly regarded since they have been available for a couple decades already. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48%.

Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways including investing what I believe to be about $200 million in 2007 for direct-to-consumer ads for these products. To add, and soon after the medications were launched, representatives from both companies made inferences to doctors about outcomes regarding cholesterol-plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE Trial proved it is in fact not whatsoever. It did not matter, apparently, to both Merck and Schering that such a claim is entirely void of proof, which is not unique to any pharma rep, in my opinion. Yet what is known now is that these companies performed junk science with their deliberate manipulation of this ENHANCE Trial. Last year, Zetia and Vytorin had about 20% of the cholesterol lowering market. It does not seem that there will be an increase of this percentage anytime soon.

Worst of all is the harm caused to both doctors and patients. The ENHANCE Trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin.

This whole situation is another example of the corruption of the scientific method by placing profits over the well-being of patients. Most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging corruption that desperately needs to be stopped and corrected for the sake of others.

Don’t just say something. Have something to say — to the right people, with conviction, and with others who share your views.

Waste no more time arguing what a good man should be. Be one.
Marcus Aurelius

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The Human Injury of Lost Objectivity: An Insider’s Look into the Corruption of Clinical Trials /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/ /2008/04/25/the-human-injury-of-lost-objectivity-an-insiders-look-into-the-corruption-of-clinical-trials/#comments Fri, 25 Apr 2008 12:59:47 +0000 /?p=883 Drugs_Clinical_Trials2.jpgIf I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials would be at the top of the list. Pharmaceutical companies manipulate the trials they sponsor because of their power to control others involved in the process largely absent of regulation. This is a matter of requiring authenticity and, more importantly, assuring the safety of the public health.

Research instituteDecades ago, clinical trials were conducted in academic settings that focused on the acquisition of knowledge and the completely objective discovery of novel medicine. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit sites, called Contract Research Organizations (CROs), which are composed of community research sites with questionable investigators void of necessary experience or quality regarding their research purpose and ability. Since they are for-profit, the trials conducted at CROs are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s medication. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit the collusive relationship between the site and the sponsor.

MoneyFurther disturbing is that once the trials are completed, the medical articles are then written by ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers. How often ghostwriters are utilized by pharmaceutical companies remains a mystery. This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor. To have the trial published, the sponsor pays a journal, along with the promise of purchasing thousands of reprints of the study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the industry. So benefits of medicine studied in such a malicious way can potentially harm patients and their treatment options. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers — your doctor.

Such misconduct impedes research and the scientific method with frightening ethical and harmful concerns. Our health care treatment with medications is now undetermined in large part in such situations, as well as the objectivity that has been intentionally eliminated regarding the trust in the scientific method in this type of activity illustrated in this article. More now than ever, meds that are removed from the market are given black box warnings. Now I understand why this is occurring.

The pharmaceutical industry needs transparency and disclosure in order to correct what we have historically relied upon for conclusive proof — the scientific method. More importantly, research should not be conducted in a manner that the sponsor can interfere in the ways I described in this article. We should call for independent sites with absolutely no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion. 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

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Pharmaceutical Industry Exposed: Desire for an Ethical Resurrection /2008/03/27/a-desire-for-an-ethical-resurrection/ /2008/03/27/a-desire-for-an-ethical-resurrection/#comments Thu, 27 Mar 2008 20:22:58 +0000 /2008/03/27/a-desire-for-an-ethical-resurrection/ Opinion2.jpgIf you have been in a doctor’s office, you’ve probably seen them. They are the ones that are unusually well dressed — considering their environment. They also are typically young, healthy, and attractive. And worst of all is that they typically pay absolutely no attention to you, the patient, as you are not their objective. Certainly, they will avoid any conversation with you as the reasons for your visits are in opposition.

They are the drug representatives… the detailers… the pharmaceutical promoters and marketers that could care less, really, about your concerns while you are both sharing the same space at the same time. Yet these reps will possibly take up the valuable time of the very doctor you are suppose to see for a health issue or concern, possibly of a serious nature. So there is actually one thing in common between the rep and the patient in the office: you both want to see the doctor, but for entirely different reasons.

Pharmaceutical marketing tactics have become more transparent to many others over the years, and their methods have been exposed more so than they have in the past. And the public doesn’t like what they hear and read, that is largely valid and authentic. This is why the pharmaceutical industry’s image has been traumatized so much during this time over the past decade or so in particular, and the trauma is deserved, considering what the industry does and has done over the years with deliberate intent and reckless disregard in some cases, by seeming to ignore patient benefits for immediate profits.

Yet there are those who are trying to change things for the better. Because pharmaceutical marketing to both doctors and patients is a troubling public heath issue, as they are a threat to the health of the community, certain advocacy groups such as National Physician’s Alliance and Community Catalyst, among others, are addressing concerns raised by the marketing tactics of the pharma industry, and their passion and ability to organize and work as a team appears obvious. I think very highly of their continued efforts to improve the well-being of others.

In a way, such advocacy groups are in fact treating a disease, if one defines a disease as being harmful or abnormal. Also, such groups are attempting to prevent disease by deterring the etiology of the disease itself. In this case, pharma marketers, yet there are unfortunately quite a few others.

In this article, I address four factors focused on by some advocacy groups and conducted by pharma companies that are trying to be fixed or eliminated by others, and where notable progress has been made:

1. Data mining

Data mining is preventing pharma reps from having prescribing data on the doctors they see on a regular basis. This data, while provided to the reps by the employers, originates with the American Medical Association. This association sells data necessary to identify prescribers and their habits, which is purchased from the AMA by the pharma companies. This arrangement is very lucrative for this association. The data the reps have from this arrangement allows them to analyze the historical prescribing habits of the doctors they are trying to influence to prescribe the drugs they aggressively promote in order to specifically create the most effective message to a particular doctor based in large part on this prescribing data. It has been stated and known that vicious debates have occurred between pharma reps and doctors because of this.

There are those that insist this data is necessary for pharma companies to improve treatment regimens and protocols for the patents the doctor sees, and state the data is useful for educational purposes. This clearly is a fallacy. Advocacy groups and others are trying assertively to have bills passed through the legislature in order to prevent pharma companies from having this data, as it is not fair for the doctors for pharma companies to have such records of thier practicing habits with the prescriptions they write, although the names of thier patients are fortunately not included. In fact, pharma’s reps have no right to possess such data, regardless of the content. Furthermore, pharma reps having this data and what they say to a doctor based on this data removes potentially the objectivity of the doctor and may interfere with the best treatment of the patient, prevents any authentic and credible relationship with the doctor, and it could interfere with the judgment of such a doctor.

2. Disclosure

Also the mainstream media to some degree has microscopically received and reported some level of acknowledgment of the money given out by the pharma industry to anyone who can potentially benefit the profitability of the pharmaceutical industry, such as their lobbying force, yet most of their collaborations, remunerations, inducements, and other forms of gifting to the medical establishment remains overall a mystery to the public and the government to a degree until they get caught by the government for wrongdoing because of these attempts at reciprocity with prescribers in attempt to form symbiotic relationships with them. Intimidation and extortion are possibilities as well. Yet insiders if the pharma industry, who choose not to be deliberately ignorant and dig deep for the truth are an exception with their drive to make others aware.

Whistleblowers have been a big help with revealing and uncovering a large part of such activities, which is a rather courageous and brave thing for them to do, considering what they risk, yet regardless, for the benefit of public health, the public consistently should have a right to know where this money goes from the pharma industry to those who are responsible for restoring their health. So again, legislation and bills are being contemplated that would mandate pharma companies to disclose what they dispense financially and for what reasons. The pharmaceutical industry is the most lucrative industry that exists, so they have the money, yet no one knows where exactly it goes. It is mysterious. And likely, if it ends up that the pharma industry reports their financial output, it will likely be an exercise in creative accounting.

We have a right to know. Of course, the pharma industry is opposed to such obligations with the disclosure issue, yet if it is for patient benefits, this money the pharma industry spends, as the pharma industry has repeatedly stated, the opposition should not exist.

A rather secretive industry… Revelation is quite a threat to the pharma industry, so it seems. Is it cronyism? A unique cult? One can only speculate.

3. Direct-to-consumer (DTC) marketing

Two countries allow this: the US and New Zealand. Here’s the problem: About a third of those who view such ads seek out their doctor and ask for the med, regardless if they need it or not. Likely they will get it. And the ads are unmonitored. If a discrepancy is discovered, it’s after an ad has been broadcasted, usually for a lengthy period of time. It is then that the FDA intervenes. Embellishments with DTC ads are obvious. Exaggerations with the disease states are apparent as well. Elimination of such ads are being considered, and should be eliminated, as it diminishes the role of the doctor, for one reason. The pharma industry believes such ads encourage others to seek treatment. Yet they are unable to determine who needs treatment, and clear definitions of the diseases that they are attempting to promote. Doctors, however are. That’s what all that schooling and training is all about with your health care provider.

4. SafeRx Act

Finally there is the SafeRx Act, being considered by lawmakers now, which aims to have reps certified by the government in order to be employed as pharma reps. Ethics are included in the training. Hopefully, the complexity of diagnosis and treatment will be integrated into the certification process as well. Unfortunately, most reps have little if any medical training. In the US, more value is placed on pharma rep selection based in large part on looks and personality. This, needless to say, can be damaging in this particular industry. Yet the act is still pending on a national level. The pharma industry states that it is a waste of time, and their stance on this issue disappoints me, yet I remain unsurprised.

Bias may exist in this article, as I am an ex big-pharma-rep myself and consider myself a pharma critic at this point, yet the contents of this article are factual and not exaggerated. Yet I still honestly recognize the benefits this industry and all that it has provided to others from a historical perspective of lifesaving drugs as well as other medications that delay the progression of chronic diseases. Their effort is acknowledged. And I applaud their efforts to improve patient health, and wish for a return of such ethics.

Maybe in time the pharma industry will become more pragmatic if the public is more empowered with knowledge. Doctors should not have any interference when it comes to the treatment of their patients. Again, there are others besides pharma that are guilty of this. I suppose the issue is best summed up by Hippocrates, who said,

Whenever a doctor cannot do good, he must be kept from doing harm.

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Medicine Deception: Uncovering the Facts /2008/03/18/medicine-deception/ /2008/03/18/medicine-deception/#comments Tue, 18 Mar 2008 15:41:36 +0000 /2008/03/18/medicine-deception/ Drugs_Clinical_Trials.jpgHere, I present just two of the many possible “unknowns” about the medications that are prescribed by health care providers:

1. The FDA requires two studies to show that a medication that is awaiting approval from the FDA is superior to a placebo — not exactly the best measurement of efficacy or the best reassurance that a patient is receiving the best medicinal treatment to restore their health. Equally surprising is that a pharmaceutical company that is attempting to approve such a medication has no limit as to the number of studies it can conduct to produce these two studies required. Some may show that their medicine, soon to be available for use by patients, is equal to a placebo, which it may not have any value, therapeutically.

2. When this newly approved medication is marketed to doctors immediately afterwards, statistical gymnastics are performed often by the pharmaceutical company marketing department. For example, blood pressure Drug A has been proven to provide a 50% relative risk reduction in heart attacks when patients are treated with this medication. Sounds impressive, huh? Lets take the same drug and state the following: Out of 100 patients studied, 2 patients experienced a heart attack who did not take Drug A, but when therapy was initiated with this medication, only 1 out of 100 patients experienced a heart attack. The first statement was designed to reflect relative terminology to state the benefits of the med, while the latter statement speaks in more authentic terminology, which is absolute terms. That’s marketing — taking a half truth and converting it into a complete fallacy.

Voltaire once said:

The art of medicine consists of amusing the patient while nature cures the disease.

There may be some truth to this…

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