My volume of recent posts on evidence and statistics (here, here, here, here) indicates how important I think it is that e-patients 'E'ducate themselves about 'E'vidence, as Sarah Greene recently wrote. Last week Ted Eytan steered me to HealthNewsReview, which scrutinizes news coverage of health stories. Newspapers and TV are covered.
When you're new to a subject, as I am to scrutinizing evidence, there's nothing better than this to help you learn. A few examples:
Elderly fare well in open-heart surgery (Associated Press) got two stars of a possible five:
This story failed to provide balance for a reader to understand the risks and benefits of this line of treatment, what other options are available, or the costs involved. Other than gaining the insight that the outcomes are better today than they were in 1989, the reader did not learn much beyond the fact that surgical treatment of coronary conditions may be an option for those in their 80s and 90s. Full reviewA single test to detect many winter ailments (Wall Street Journal) got a perfect five stars:
... a good job of presenting accurate, comprehensive information ... the test is presented in context of a key health issue: the under-diagnosis of the flu in vulnerable populations, such as children, versus the inappropriate and unneeded prescription antibiotics in cases where they are ineffective in treating the flu. This story takes a balanced approach in presenting the evidence supporting the pros and cons of the test. It could have been improved by stating that it is not necessary for most routine febrile illnesses in the outpatient setting. Full reviewA search for keyword "statins" shows that almost all stories on statins (at least the ones the site reviewed) are poor. Example, from the LA Times 11/10/08, Statins may benefit healthy people too:
This story fails to be skeptical about claims of self-interested researchers. Rather than pushing back against exaggerated claims of benefits, safety and guideline changes, the story magnifies them.Another review I spotted dinged an article for talking only about relative risk reduction, not raw numbers. That's consistent with the Making Sense paper, as I wrote earlier.
Ted Eytan is a pretty nifty MD. Clearly believes in teaching patients anything they want to know about.
I've written for Gary Schwitzer with Health News Review in the past, and agree with your stance regarding the annotative flaws, with often deliberate intent, in our journalism and mass media:
ReplyDeletePress Release: A Well Designed Sales Pitch
Those who release and create press releases, that are intended to offer information that is authentic and newsworthy, are possibly in collusion with various sources of the mass media who receive these announcements from others with commercial interests in mind, and instruct such media outlets with mandated authoritarian nuances, such as the press release that they created will be void of alteration of any kind of their press release as directed to the receiver by the creator and sponsor of such press releases. The sponsoring organization that composes press releases does so in order to promote their organization and its products, and this much is rather clear. These well- constructed statements are meticulously composed and customized before they are issued to targeted editors for mass media publication at select locations and times of release by this sponsor. 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, others have said.
Press releases are a form of public relations often utilized for those companies who create what is supposed to be an attempt to express their products that they wish to convince readers that such products are innovative or 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 releases 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 develops them solely to increase awareness and usage of their products that they promote with their business, which they want to be viewed as favorable with a positive image to the public. One could suggest that the mass media who receives these press releases 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 for the readers, the American Public, who believe that what they are reading is honest and complete. This, however, is not the case is certain situations.
An example is an anonymous and 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."
Clearly, this title itself includes words associated with relief or elation, which are subjective and not objective elements which would clearly be more appropriate, according to some, if the press release was created to inform the reader, one could say.
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 regarding Cymbalta remarkably were not stated in this press release.
What is not included in this particular press release was 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 standard in the pharmaceutical industry and health care journalism. The staff involved with the release and publication of such press releases as this one 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 others- more so with such medical issues in particular. Because these so many of these potential readers are in fact us- public citizens who deserve much more than half truths and possible fabrications created by those whose instead of sharing with the public authentic and unbiased information should be demanded by us from those who provide such media to us.
Dan Abshear
Absolute numbers are raw numbers that present more meaning and accuracy than 'relative risk reduction'.
ReplyDeleteRegarding statins:
Facts Believed to be Associated With All Statin Medications:
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. Since this class of drugs has existed for use for over 20 years, statins are considered safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients.
Additionally, there is no reduction in cardiovascular morbidity or mortality, as well as an increase in a person’s lifespan, if one is on any particular statin medication for their lipid management. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient if they are absent of dyslipidemia to a significant degree, or 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 statin therapy for their patients is considered reasonable and necessary if the LDL in their patients need to be reduced.
Abstract etiologies for those who prescribe statin drugs on occacsion , such as reducing CRP levels, or for Alzheimer’s treatment, or anything else not involved with LDL reduction is not appropriate prophylaxis at this point for any patient. All other benefits that appear to have favorable effects in such areas are speculative at this point, and require further research for disease states aside from dyslipidemia.
Several risk factors should determine if one is placed on statin therapy, and not just one particular reason. High LDL cholesterol is the apex of rationale for statin therapy, yet other risk factors of the patient should be examined and evaluated as well by their health care provider, perhaps- depending on the patient’s cardiovascular history to determine the appropriate dosage and strength of statin therapy for such patients as it relates to their present LDL level and the reduction that is needed.
Statins do decrease the risk of cardiovascular events significantly, it has been proven. This may be due to the fact that statins improve endothelial function as well as statins having the ability to stabilize coronary artery plaques, which prevents myocardial infarctions. Statins also decrease thrombus formation as well as modulate inflammatory responses. 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.
In regards to other uses of statins besides just LDL reduction, there is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP) with patients on statin therapy, those patients with dementia or Parkinson's disease may benefit from statin medication, as well as those patients who may have certain types of cancer or even cataracts. Yet again, these other roles for statin therapy have only been minimally explored. Because of the limited evidence regarding additional benefits of statins, 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.
It appears those statins that are produced specifically by fermentation, such as Zocor and Pravachol, have less incidences of myopathy than the other synthetic statins that exist presently.
This may possibly due to the fact that fermented statins are believed to be much more hydrophyllic, which may optimize safety for a patient on a statin medication. Regardless, the lower the dose, the better, with any pharmaceutical prescribed to a patient. All pharmaceuticals have side effects, or they would not be pharmaceuticals. Statin drugs are not an exception.
Yet overall, the existing cholesterol lowering recommendations or guidelines should be re-evaluated, as they may be over-exaggerated upon 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 others in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable, unnecessary, and possibly detrimental to a patient’s health, according to others. 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.
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.
Dietary management should be the first consideration in regards to correcting lipid dysfunctions before initating pharmacological therapy,
Dan Abshear