EVIDENCE-BASED MEDICINE & OFF-LABEL PRESCRIPTIONS
"All off-label drug uses are not created equal. A study published in November 2015 in JAMA Internal Medicine compared prescription drugs used for off-label indications with and without strong scientific evidence to back the alternative use. When that evidence is lacking, there's a 54 percent increase in adverse drug events." From Lisa Esposito's April 22, 2016 article in US News called What Patients Should Know About Off-Label Drug Use. The problem is, according to the November 23 issue of the Wall Street Journal (Risk of Off-Label Uses for Prescription Drugs), "The JAMA Internal Medicine study found that about 80% of off-label prescriptions weren’t supported by strong scientific evidence."
"While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. It is also common. For the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice. For example, about 80 percent of all drug prescriptions for children are off-label." Cherry-picked from Jann Bellamy's March 2016 article for the highly anti-alternative medicine website, Science-Based Medicine (Patient Beware: Off-Label Drug Promotion by Pharmaceutical Companies). Follow along as I show you how the restrictions on off-label drug promotions are going bye-bye.
As I've shown you time and time again, evidence-based medicine is frequently anything but. However, if Big Pharma can come up with catchy ads and talk a good enough fight to make people think that the thousands of studies they are paying universities, research centers, and think tanks to do each year are unbiased proof that their products are wonderful and effective, they will have fooled the public enough to make billions. Today's post is going to help burst that bubble and show you the interesting and potentially ugly side of recent changes in the law concerning the promotion of off-label prescriptions.
When medications are prescribed "OFF-LABEL," it simply means they are being prescribed in a manner that has not been studied or approved by the FDA. In other words, if a doctor started prescribing a certain arthritis drug for people with depression, or prescribed it for groups of people (i.e. children / pregnant women) that had not been studied, this would constitute OFF-LABEL PRESCRIPTION. The biggest official stipulation put on this practice by the government is that drug companies cannot advertise off-label uses of their meds. All of this begs the question of just how common off-label prescribing may be?
Off-label prescribing is extremely common. As I showed you a few years ago concerning ANTIDEPRESSANTS, off-label use is arguably the most common way this class of drug is being prescribed. Despite this, the title of a study published in a May 2016 issue of Medscape (Off-Label Antidepressant Prescribing Increasingly Common) showed us through its title that this practice is getting worse instead of better. The paper went on to say that, "Investigators at McGill University, in Montreal, Canada, found that 45% of the antidepressants prescribed... in the province of Quebec were for conditions other than depression." The problem is at least that bad here in the United States. I could literally write a book on this topic, but that is not the purpose of today's post.
Today, I want to let my readers know that as of recently, things got much easier for Big Pharma to push their wares on an unwary public in off-label fashion. On December 29 of last year (less than a week ago), the Managing Editor for MedPage Today (John Gever) published two articles on the same topic --- FDA Concedes Defeat on Off-Label Drug Marketing and Will Off-Label Promotion Become a Fact of Doctors' Life? As strange as it may sound, this story started five years ago with a drug that's based on Pharmaceutical Grade Fish Oil.
As I've shown you about a million times, INFLAMMATION is the root cause of most diseases. On the other hand, PHARMACEUTICAL GRADE FISH OIL has been proven effective for helping people with a wide variety of health-related conditions simply because Omega-3's are extremely anti-inflammatory. Be aware, however, that peer-review is never unanimous in it's assessment of any supplement, fish oil included (HERE, HERE, HERE, HERE, or HERE). Although there are lots of reasons for this (that's why I provided you a few links), when it comes to fish oil, much of it has to do with the fact that most grocery store or health food store fish oils are rather crappy products (click the PGFO link above to see why), with low levels of EPA and DHA --- the two active ingredients in fish oil, not to mention the fact that most of it is rancid / oxidized. Enter Amarin Pharma, Inc.
In July of 2012, the FDA cleared Vascepa --- a prescription fish oil product made from highly purified and concentrated EPA --- for use in treating people with high triglycerides (high levels of blood fats aka hypertriglyceridemia). This categorizes Vascepa as a "Medical Food" (Medical Foods are nutritional products that have been molecularly tweaked enough to be patented, yet still retain their beneficial food-like qualities). The products I am most familiar with in this class are Deplin and Metanx (for DEPRESSION and DIABETEIC NEUROPATHY respectively). Effective for some people but very expensive. Anyway......
Because Big Pharma understands the benefits of using fish oil to treat people with inflammatory conditions, they started pushing the FDA to allow their product to be advertised in an off-label fashion (not prescribed or used off-label mind you --- those are already legal --- but advertised). As of September of 2014, it wasn't working out so well, as seen by the title of The Street's article called Third Time Was No Charm, FDA Denies Amarin Vascepa SPA Appeal. But with so much money at stake and lots of attorneys on retainer with nothing better to do, Amarin went after the FDA yet again.
In May of 2015, the Wall Street Journal wrote an article about this battle called Amarin’s Vascepa Revenue Grows 42%: Small Drug Maker is Suing FDA Over Free Speech Right to Promote Off-Label. And guess what? In July of last year, they actually won based on a judge ruling that not allowing off-label prescribing was a violation of the right to free speech. So instead of our problem with drug advertising getting better, it's about to get worse --- much worse.
Case in point, Cardio Brief's September 2016 article by Larry Husten titled Amarin Begins Legal Off-Label Promotion Of Vascepa stated that, "Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product. The federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing that information is neither false nor misleading." The problem is, both politicians and Big Pharma have different definitions than the general public as to what the words "false," "misleading," and any number of others (including "is") actually mean. Take, for instance, Vascepa's website.
It is my opinion that their website (you can look it up as I am not going to promote it by providing a link) is an exercise in misrepresentations and half truths (many of the later probably much less than half). For instance, their website opens up with, "Why should you take Vascepa instead of fish-oil supplements? Unlike Vascepa, dietary supplements are not approved to treat medical conditions." They then go on to talk about fish oil supplements as compared to Vascepa.
Everything they say is mostly or at least partially true (I revealed virtually everything they mention at least a decade ago in a handout that I turned into a web page --- HERE), but much of it is taken way out of context or presented in a very twisted and convoluted manner. If the problems with Vascepa --- a supplement whose chief side effect is joint pain --- ended there (interestingly enough, the number one reason people in my office take PGFO is to relieve joint pain), it wouldn't be such a big a deal --- after all we are talking about fish oil here. Unfortunately, the judge's ruling pertained not just to Vascepa, but to pharmaceuticals in general. Put on your ten-gallon hats and polish your six-shooters --- you are about the experience the pharmaceutical industry Wild West style.
In last week's MedPage article, Gever wrote that Big Pharma can, "now feel free to say anything they like to physicians and consumers about their products, as long as they had some fig leaf in the form of a journal paper or PowerPoint slides from a conference." If you ever get a chance to look at paintings or engravings of Adam & Eve after their confrontation with God in the Garden, they are usually depicted with A FIG LEAF OR TWO in strategic locations. When it comes to Eve, the single fig so often depicted in ancient artwork leaves little to the imagination. The point is that when it comes to EVIDENCE-BASED MEDICINE, not only are fig leafs common, they are arguably the norm (click the link and start skimming the dozens of titles).
"In March, the FDA reversed decades of policy, allowing drug maker Amarin to tell physicians about studies showing its prescription fish-oil product Vascepa may be effective for unapproved uses. Previously the agency had a near-zero tolerance policy for off-label promotion of drugs and devices, but Amarin sought and won a federal court ruling that 'truthful and non-misleading speech' about products is protected under the First Amendment." From the article currently being discussed by John Gever
Firstly, this whole affair begs the question of what really counts as protected speech under the First Amendment. Can I really tout Chiropractic as a "cure" for deafness (HERE) even though BJ PALMER originally did? We know that it is clearly illegal to go into the proverbial "crowded theater" and yell 'fire,' or start making insinuations about bombs on public flights. On the other hand, it's perfectly legal under the First Amendment for producers of porn to use models who, while being of legal age (18), appear to be younger --- some of them much younger (HERE). Where do we draw the line? For starters, I would argue that free speech is meant to grant political and personal protection (HERE); commercial protection much less so.
Because of this I would also argue (you'll have a tough time moving me off this point) that free speech and First Amendment protections have nothing whatsoever to do with off-label promotions of prescription drugs. But let's look at the other side of the coin for a moment. According to the author who is quoting FDA Commissioner Dr. Robert Califf, "physicians aren't expected to rely solely on FDA-approved communications about available drugs. We know that healthcare providers can already access considerable scientific information about unapproved uses through a variety of sources, including scientific journals, clinical practice guidelines and compendia, or by requesting information from firms."
Look folks; if everyone was really working toward the common good of the patient, this might (might) be true. However, with the various ways (HERE and HERE for instance) that Big Pharma is conning and defrauding both the public and the governmental agencies (FDA, NIH, CDC, etc) assigned to police them (INVISIBLE & ABANDONED STUDIES continue to be one of the most common and most effective), Califf's reasoning is not valid.
One of the commenters on Gever's article (Dr. DeeDee) sided with Califf, saying, "Bureaucracies thrive on controls and regulations. I simply believe that physicians - all properly trained and examined in their profession - remain the best-qualified to decide what is best practice for their patients, and to separate the good from the chaff during promotional meetings with Pharmaceutical Industry Representatives (whose overall contributions to our ongoing knowledge-base remains very significant). There remains a need for Rules and Regulations dictating a baseline safety level for honesty and propriety in the development and manufacture of medicines, but does this extend beyond the early "learning curve" into the best practices era? I think not, and most certainly believe that I am my own best censor in my professional field of competence - not some unaccountable unknown bureaucrat." Well spoken, but according to study after study after study, completely untrue. You are affected by advertising.
If advertising, whether through DRUG REPS, TV COMMERCIALS, PRESS RELEASES, pathetic "FIG TREE" STUDIES and HOMEGROWN RESEARCH, a steady stream of MEALS, continuing education in Aspen or Key West, Clinton-style honorarium for speaking engagements, "consulting" fees, etc, etc, etc, etc, didn't work, BIG PHARMA (watch the humorous "TV commercial" at the end of this link), wouldn't be spending billions and billions of dollars each and every year to peddle their products and influence. The fact is, BMJ showed us nearly five years ago that for every dollar industry spends on research, they are spending almost twenty times that on advertising. No one, doctors included, likes to admit they are capable of being played by the pharmaceutical industry's schmooze & schtick. But being played they are --- over and over and over again (HERE --- the truth is, I could have put dozens of different links in this spot).
When it comes to the "Bureaucratic BS In Medicine Top Ten List," the the top spots should be held by phenomenon like FINANCIAL CONFLICTS-OF-INTEREST, FAKE "HEALTH CRISIS," and HEATH GUIDELINES that are so bought and paid for no one's even trying to hide it any more. And to think that Pandora's Box was opened over a drug that is, for all intents and purposes, a nutrient.
Dr. Schierling completed four years of Kansas State University's five-year Nutrition / Exercise Physiology Program before deciding on a career in Chiropractic. He graduated from Logan Chiropractic College in 1991, and has run a busy clinic in Mountain View, Missouri ever since. He and his wife Amy have four children (three daughters and a son).