Pharmaceutical News by Press Release? (OR: Low Dose Naltrexone Study Doesn't Make the News)

In the article, “Statins (Crestor) for Everyone?”, I wrote about how the AstraZeneca-funded JUPITER study (JUPITER stands for “Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin”) made a case for putting many more people on statins, especially on AstraZeneca's own Crestor. In the article, I pointed out several troubling facts, including that studies funded by pharmaceutical companies are much more likely to have positive results than those that are not industry-funded, and that many of the “news stories” about the JUPITER study reported “the facts” of this study, almost word for word, as they appeared in AstraZeneca’s press release. 

In her November 14, 2008 Columbia Journalism Review article, "Science Reporting by Press Release,”  Cristine Russell calls this kind of “reporting” the “dirty little secret of journalism.”

The subject came up recently in a conversation I had with Burt Berkson, MD, PhD, pioneer in the use of alpha lipoic acid, and more recently, of low dose naltrexone (LDN), as well, for treating some very serious diseases and conditions -- without the side effects of more toxic pharmaceuticals. Dr. Berkson was telling me that, at one of the conferences he spoke at, LDN researcher Dr. Maira Gironi told about the wonderful results she was having in Italy, reversing multiple sclerosis with LDN. (You may read about Dr. Gironi's work with LDN here, here and here.)

Dr. Berkson noted: “But you hear nothing about it because there are no very wealthy corporations promoting it.”

His words brought to mind the fact that Dr. Gironi had presented a paper on this study at the 60th annual meeting of the American Academy of Neurology in Chicago, in April, 2008, around the same time that I was interviewing several of the LDN patient and physician advocates for my article, “Four Lifesaving Medical Treatments: Not So ‘Anecdotal,’ After All.” Everyone I spoke with was excited about the very positive results Dr. Gironi was getting in Italy with LDN for MS. They were eager for her paper to be presented at the AAN meeting in Chicago.

Indeed, Dr. Gironi did present the paper on LDN. But, as Dr. Berkson noted in our conversation, there were no big press announcements about her paper.

So, I went online to see what had happened –- and why there was such silence.

What I found was that, while there had been silence surrounding the LDN study  (which had no pharmaceutical company backing), at the same conference one of Dr. Gironi’s LDN co-investigators, Dr. Giancarlo Comi, had also presented a paper on another MS drug, FTY720 (fingolimod). The research on this drug had been funded by the pharmaceutical company, Novartis.

News stories about this pharmaceutical-company-funded study/presentation abounded. The drug was called a “novel oral therapy.”

But then, I began to notice something very curious: ALL the “news stories” about fingolimod had the same identical wording, from beginning to end.

I knew exactly where to go to learn where the wording had come from. There it was, in the April 15, 2008 Novartis company press release, titled “FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment.” 

Then, I went to medicalnewstoday.com, which boasts that it is “the largest independent health and medical news website on the Internet.” Well, not so independent, after all -- because there it was, on the very same date (April 15, 2008), a news “article,” titled -– Surprise! -- “FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment,” with the same exact wording as the Novartis press release.

And the same day, on www.bio-medicine.org, which purports to contain “the latest biology and medical news,” this identically titled article ran: “FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment.”

And again, it ran (same title, same wording) on biospace.com and on World Pharma News -- and so it went, on many other “scientific” sites, too.

Is this why the “big news” to come out of the AAN meeting was NOT about low dose naltrexone, but rather, about a pharmaceutical company-funded drug? What do you think?

To learn about how Big Pharma also writes (or commissions to have written) the "scientific" medical journal articles about the pharmaceuticals they "study" and manufacture, read Dr. John Abramson's Overdosed America and Melody Petersen's Our Daily Meds. In addition, there is a wonderful PBS interview with Ms. Petersen, in which she talks about this phenomenon (she says the pharmaceutical industry calls it "publication planning").

Comments

[Dan]

Those who design and create releases for the press, which is the print media, is designed to contain information of sufficient importance or interest to the public, historically speaking.
Instead, those who design and release written information to the press are often sponsors of the print media who will issue the press release. Such sponsors often instruct such media outlets with mandated authoritarian nuances, such as the press release that they created will not be altered in any way by the print media that agrees to release the press created by the sponsor of the media outlet.
Of course, the sponsor and creator of such a press release creates such written words in order to promote the sponsor itself, as well as its products. By doing so, they are allowed the freedom to embellish if not fabricate what may be annotated on the release they issue to the press that has now been bought by them, the corporate sponsor.
These well- constructed statements are meticulously composed and customized before they are issued to targeted editors and contacts at mass media publication locations.
The sponsor also has been known to direct the location and time of the release of their press creation that, upon direction from the sponsor, is completely un-reviewed by such a media source.
As this is done, the mass media outlets are again instructed on how to present their completed statements, as well as are given instructions once again not to alter these press releases in any way, as part of the agreement between the print media source and their sponsor.
As a result of this collusion, press releases are presently a form of public relations often utilized for those companies who create what is supposed to be an attempt to express their products as being newsworthy.
Press releases, historically, have been created and released to inform the readers by adding insight and related information for them regarding a particular topic that was typically complete and balanced.
Today, they seem to be more or less an annotative commercial with press compositions generated by corporations in particular, so it seems.
Unfortunately, and presently, press releases are often embellished, biased, and incomplete with deliberate intent in order to benefit the creator of these documents, who again develop them solely to increase awareness and usage of their products that they promote with their business, which they want to be viewed as favorable and with a positive image to the public.
One could suggest that the mass media who receives these press statements from certain corporations are transformed into mass front groups who perhaps coercively offer third party legitimacy for the content of the press release as they release this information to their readers.

The often notable if not intentional flaws at times are numerous within such press releases that reflect reckless disregard with informing readers in such a way, who are the American public. Citizens typically believe that what they are reading from a respected media source is both honest and complete.
An example is an anonymous press release posted on the Medical News Today website (www.medicalnewstoday.com) that is dated in March of 2006. The title: "Cymbalta Safely and Effectively Treats core anxiety symptoms associated with generalized anxiety disorder."
Cymbalta, by the way, is a psychoactive drug often utilized for human affective disorders.
Clearly, this title itself includes words associated with relief or elation, which are subjective and not objective elements which would clearly be more appropriate- with a health care press release in particular.
The first paragraph of this press release repeats the results mentioned in the title of this article, but also states Cymbalta offers relief of painful symptoms associated with anxiety, as well as improved functional impairment- also claimed to be associated with anxiety in this press release.
These conclusions are speculative at best, as these inferences appear to be unexamined by others regarding the benefits claimed to exist with Cymbalta as illustrated in this press release.
Cymbalta was not approved by the FDA for anxiety or any of the symptoms associated with this condition at the time of this press release. In fact, Cymbalta was not filed with the FDA for this speculated new indication for anxiety that was desired by Eli Lilly until May of 2006.
By definition, this press release may possibly be off-label promotion as well as misbranding of Cymbalta that was performed overtly in this manner of the press release, one may speculate.
As one continues to read this press release, testimonials were intentionally created and inserted into this press release that illustrated results they hope are impactful to the reader regarding Cymbalta.
This testimonial was from the lead author, who expanded the claims made initially with utilizing various medical terms, which was followed by this person’s passionate optimism about the great potential of Cymbalta based on this remarkable study.
This study, by the way, was to be addressed in further detail at a National Anxiety meeting some weeks after this press release was announced to the public on this website.
The second testimonial was Eli Lilly's Medical Advisor expressing his elation about what the lead author just stated, followed by how much he was encouraged by these results that will benefit so many others that have these debilitating medical conditions.
Of course, profit forecasts and desired market growth and expansion regarding Cymbalta remarkably were not stated in this press release.
What is not included in this particular press release were any clear statements regarding the disadvantages and adverse if not toxic events associated those who take Cymbalta.
Reactions from Cymbalta users include discontinuation syndrome at times, when the user stops taking this medication, which I understand can be quite devastating for the one experiencing this syndrome.
Furthermore acts of suicide and suicidal ideation have been frequently associated with those who take Cymbalta as well. There have been apparent lack of efficacy suggestions by others who have taken Cymbalta.
Basically, anything that may be considered negative aspects about this drug were not annotated in this particular press release as it should have been for fair balance that is or should be a primary standard in the pharmaceutical industry and health care journalism.
The staff involved with the release and publication of such press releases as this one was annotated and described should perhaps be more informed on what not to accept and what to present regarding these issues addressed.
As with any reporting by the media, objectivity and thorough completeness of the topic discussed in a press release is a necessary requirement with any publishing that is potentially exposed to so many other readers- with issues related to the restoration of their health in particular:
“The public has a lot at stake, and the media has a responsibility always to be aware of the source of information and the conflicts those sources might have when they report the results of clinical research. People who have financial stake in the results of clinical research can well be biased in the way research is conducted, in the way they report it, and what they say about it when interviewed by the media.”
– Arnold Relman, former editor in chief of the New England Journal of Medicine

Dan Abshear

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What Is Believed To Be Qualities Of All Statin Medications:

Statins are a class of medications specifically prescribed to lower LDL- one of five lipid parameters of a person’s lipid profile, which is alto the name of the blood test to measure these parameters. They are beneficial for those patients with dyslipidemia and cardiovascular disease, primarialy.
There are about 6 available statins to choose for lipid management as needed- with three that are combination drugs that have a statin included in these drugs.
There are other classes of medications for lipid management, such as bile acid sequestrants and nicotinic acid, which is known as niacin. Yet the side effect profile is more unfavorable of these classes of medications compared with the statin class of drugs.
One’s cholesterol level is primarily due to how they produce cholesterol in their liver, which is overall genetically determined. This level is also determined by one’s lifestyle and diet as well. If a person has too much cholesterol in their blood, it can lead to hardening and narrowing of their arteries as well as the formation of coronary plaques in the coronary arteries.
If these plaques break off of the arterial wall, this leads to a myocardial infarction, or heart attack. Statins are believed to stabilize coronary plaques so this does not occur.
To measure one’s cholesterol, a blood test called a lipid profile is obtained from a person after they have fasted for at least 12 hours. The test should also be performed only if the person is free of any acute illness, as this may affect true lipid measures.
If the results prove to be abnormal, lipid altering medicinal therapy may be initiated- according to the discretion of the person’s health care provider. This therapy usually involves a statin medication.
Adverse events associated with the statin class of pharmaceuticals are thought to occur more often than they are reported- with high doses of statins prescribed to patients in particular at times that may not be necessary to control their dyslipidemia based on their lipid profile. Side effects may include muscle pain, or possible damage to the patient’s liver.
However, since this class of statin drugs has existed for use for over 20 years, statins are considered to be overall safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients.
Also, they have proven to reduce cardiovascular mortality with one who is treated with a statin that has dyslipidemia. In addition to lowering LDL by up to about 60 percent- depending on the choice of the statin prescribed for the patient, and how high the LDL cholesterol is in a patient.
This class of drugs also has the ability to raise their HDL lipid parameter as well as lower to their benefit their triglyceride parameter of their lipid profile. Both of these additional effects in addition to lowering the LDL parameter from taking a statin drug is ultimately beneficial for the patient on a statin drug for lipid management.
Statin therapy is also recommended for those patients who have a greater than twenty percent risk of developing cardiovascular disease, or those patients that have clinical evidence of this disease.
Additionally, there appears to be no comparable reduction in cardiovascular morbidity or mortality, as well as a difference in the increase of one’s lifespan, if one is on any particular statin medication for their lipid management over another, others have concluded. So caution should perhaps be considered if one chooses to prescribe a statin for a patient if they are absent of, or have only mild dyslipidemia to a significant degree.
Furthermore, research should be done by the health care provider if they are under the belief that one statin medication provides a greater cardiovascular benefit over another. In other words, the health care provider should be assured that any choice of statin therapy for their patients should be considered reasonable and necessary if the LDL in their patients need to be reduced.
Furthermore, the statin selection should be determined by the results that have been shown with a particular statin.
There exist abstract etiologies for health care providers at times to choose to prescribe statin drugs on occasion for reasons not indicated with the medicinal treatment of these statin drugs. Examples include the speculated benefits associated with statins- such as reducing CRP levels, or for Alzheimer’s treatment, or other reasons not directly related to cholesterol management.
Statin therapy for such patients may not be considered appropriate, reasonable, or necessary prophylaxis at this point for any patient who does not have the indications for which statins are approved for to treat patients with dyslipidemia.
All other benefits that appear to have favorable effects in such areas not involved with a patient's cholesterol are suggested at this point due to minimal research in these other variables aside from lipid management.
Other reasons for placing a patient on a statin drug at this time require further research for these disease states and dysfunctions that may exist with a patient aside from dyslipidemia.
Statins as a class of drugs seem to in fact decrease the risk of cardiovascular events significantly, it has been proven. Statins also decrease thrombus formation as well as modulate inflammatory responses (CRP) as additional benefits of the medication.
For those patients with dyslipidemia who are placed on a statin, the effects of that statin on reducing a patient’s LDL level can be measured after about five weeks of therapy on a particular statin drug.
Liver Function blood tests are recommended for those patients on continued statin therapy, and most are chronically taking statins for the rest of their lives to manage their lipid profile in regards to maintaining the suitable LDL level for a particular patient presently. Patients should be made aware of potential additional side effects as well, such as myopathy and muscular dysfunctions that occur on occasion when one is on statin therapy.
Yet some have said that about half of all strokes and heart attacks that do occur are not because of increased cholesterol levels of these patients. So it appears clear that high cholesterol may not be an absolute for cardiovascular events for them to occur.
Others believe that it is oxidized cholesterol that causes vulnerable plaques to form on coronary arterial walls, which is the catalyst for a heart attack, and that there is no medicinal treatment for the formation or stabilization of these plaques to prevent heart attacks or strokes.
Some who support statin medicinal therapy for their clinically appropriate patients claim that these drugs, do, in fact, stabilize these plaques as an added benefit, and therefore are beneficial.
As stated previously, in regards to other uses of statins besides just primarily LDL reduction, there is some evidence to suggest that statins have other benefits besides lowering LDL, but not enough evidence yet.
These other disease states include aside from what has been stated already, such as those patients with neurological disease, as well as statins being beneficial for certain cancer patients. Some have suggested that statins interfere with cancer treatment with bladder cancer patients as well. Yet again, these other roles for statin therapy have only been minimally explored and researched, comparatively speaking.
Because of the limited evidence regarding additional benefits of statin medications, the drug should again be prescribed for those with dyslipidemia only at this time involving elevated LDL levels as detected in the patient’s bloodstream.
Yet overall, the existing cholesterol lowering recommendations or guidelines should possibly be re-evaluated. The cholesterol guidelines that presently exist may be over-exaggerated possibly due to tacit suggestions from the makers of statins to those who create these current lipid lowering guidelines.
This is notable if one chooses to compare these cholesterol guidelines with the other guidelines that have existed in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable and unnecessary, as well as possibly have the potential to be detrimental to a patient’s health.
Yet statins are beneficial medications for those many people that exist with elevated LDL levels that can cause cardiovascular events to occur because of this abnormality. What that ideal LDL level is may have yet to be empirically determined.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and this may prevent them from being candidates for statin therapy now and in the future, regarding the high cholesterol issue. Treating children with a statin drug for dyslipidemia is controversial presently. Dietary management should be the first consideration in regards to correcting lipid dysfunctions that may exist in patients.
www.americanheart.org
Dan Abshear

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This is notable if one chooses to compare these cholesterol guidelines with the other guidelines that have existed in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable and unnecessary, as well as possibly have the potential to be detrimental to a patient’s health.

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