A Magic Elixir for Everlasting Life? — 3 Warning Tips from California Researcher

Is butter really better?

What triggered Opioid popularity?

Are annual mammograms best for every adult woman?

Why are treatments for enlarged prostate more common in certain parts of the country?

Each of these questions could constitute an entire post. Spoiler Alert: I don’t plan to address any of them. However, when we do seek answers, how do we approach such questions? Research and studies are a good path forward. And if that magic elixir for long-lasting life is hawked on TV, with any luck, research will be quick to follow.

Yet, we never know when the ‘snake-oil’ is actually going to work, or the latest chemical ‘miracle’ turns out to disappoint all, often with dreadful side-effects. What do we trust? Where do we turn?  AND do we ourselves have a role?

Interviewing Barbara North, Ph.D., M.D.

With smoke smothering the sky outside, and creating poor air quality indexes all around us, I had the luxury of spending a lovely Saturday afternoon in a Southern Oregon Brew Pub known as the Standing Stone. I was there to interview a California researcher and practicing family physician, whom I know through other channels. Admittedly, much of our conversation was off-topic banter. However, eventually, I got around to the interview portion, asking Dr. Barbara North about tips for my readers when they need to evaluate research.

Given her background (see her bio below), it was not surprising that she confided to me that this is a topic of immense interest to her. She has even considered lecturing on understanding and assessing studies. So, by happenstance, I had found just the right person to prevail upon.

Tips on Research

No one expects lay people to spend their days reading research studies in depth. Yikes. Yawn. However, when it comes to a personal situation – your health or that of a loved one, you may want, and need, to learn all you can. Compared to health care professionals, you are probably at a disadvantage when evaluating research (assuming it is not your background), but it isn’t impossible either. You can do it. And considering the possible ROI on your time, it may be well worth it to you.

Tip 1 – Triple Scrutinize the Source
(Who paid for the research? Who conducted it? Who published it?)

Dr. North didn’t exactly say “follow the money,” (that’s my interpretation) but it’s a part of ‘scrutinize.’ She explained that most studies are funded either privately or by the NIH (National Institutes of Health). While NIH has no financial motive, researchers can still bring along their general points of view. Not to mention that changes in federal government administrations can also create changes (or havoc) at the NIH. However, she pointed out that NIH has large advisory boards; this helps eliminate (or at least police) any bias. Universities (some with, some without financial incentive) generally have advisory boards for oversight as well. Nevertheless, everyone involved in research can have preconceptions.

Before work is even started, agendas may creep in. Foundations too can demonstrate their partiality when determining which parties they award grants. Money won by whom? For what purpose? What question will be explored? Will the outcome of the research support a particular point of view? It’s essential to keep an eye open to the sponsor’s ‘hidden’ (or not-so-hidden) agenda, financial gains or political interests. Sometimes the organization or company is already on the front page of the news, like the Bill and Melinda Gates Foundation or the Koch Brothers.  But not always. What then? One way to explore this yourself is to find and read their mission statement. It is often stacked full of clues, and almost always available online. Scrutinize.

To no one’s surprise, this partiality-risk may be heightened with privately funded research. There can be obvious bias or a covert attempt to reach the “right conclusions.” Looking at the intervening institution that is managing the private money research can (perhaps) give you a clue as to any veiled objectives. *

*Regardless of any reasonable discussion about the quality of a particular vaccine, the study conducted by Andrew Wakefield (“father” of the anti-vaccine movement) is an excellent example of bias. His 1998 publication, which linked the MMR vaccine to autism (and colitis), was funded by a legal group in the process of suing vaccine manufacturers. Wakefield did not disclose this obvious conflict of interest to the Lancet journal who published his study. Worse yet, upon review, it became clear that his published data were actually falsified.  The publication was later retracted. This type of overt bias and misinformation detracts from any evenhanded debate over the manufacturing safety of vaccines.

There is some protection from bias when study results are published in a “peer-reviewed” journal. In fact, these publications often scrutinize research funded by industry more carefully than that funded by other “neutral” sources. But unfortunately, the results of privately funded research don’t have to be published or even made available to anyone. Consequently, any study that does not support the safe and effective use of a particular drug or device may never see the light of day. Even though the FDA does require reporting of any safety issues that may show up, this kind of information may be withheld as “not significant.” Hmmm. You can imagine that sometimes it is very significant. If safety issues are discovered, the FDA may act, withdrawing the product from the market, or refusing to approve it in the first place. This is where the ethics and honesty of the sponsor are tested.

Even individual researchers employed in Universities with unbiased funding sources, such as NIH, can have innate bias. They may well have built their careers working in a certain field and have a stake in a specific outcome. For example, a researcher who has previously shown that a drug causes heart attacks is likely to want to see that outcome supported in future work. They become the “expert” in their area and, consciously or not, don’t want to see conflicting data contradicting their expertise. So take a quick search online (at their University website) to review what they have previously written via titles of their prior publications. Of course, it’s a different story if multiple studies from multiple researchers support the same conclusion.

Another key is references and sources. If you are reading a secondary source (meaning it was not their research), they should list (and link to) the primary source. Be a bit suspicious if they don’t, because you want to avoid summaries that are cherry-picked. Use your search engine to locate a few quoted words, or search for author and study title if available, and see if the original study pops up. Reading just the abstract, conclusions or summaries may provide sufficient information as a place to start.

Tip 2 – Check the Design

[Note from drb. In very basic terms, literature reviews use conclusions from other studies and cite them in their new summarized work. Slightly different, meta-analysis generally draws new conclusions from evaluating the aggregated data of the earlier studies. Both look at multiple previous studies.]

Dr. North mentioned that meta-analysis may give us solid information and can be very helpful. But for individual studies, the design is of utmost importance. Most readers know the term “double blind study” and that it’s a preferable approach.

Three important factors in research “design.”

A. How big is the study? That is, how many people are being tested? This is called the “n” for the study. Obviously, the larger the sample size, the more reliable (statistically) are the results. For example, most FDA-approved drugs have been tested with several thousand people.

B.  Is it “blinded?” In terms of ‘Research 101’, a “blinded” study design means that either the subjects taking part in the study, or the researchers actually conducting the study, are unaware of whether or not an individual subject is using an experimental drug or a placebo. They are “blinded” to this. It is “double-blind” if both subjects and researchers are unaware of who is using what. Only after the study is complete is this information revealed. This removes the temptation and opportunity to prejudice the actual data collection and analysis. It helps eliminate partiality from both the subject and the researcher. Obviously, the goal is to keep everything the same except for precisely what you are observing (for instance, an IV drip with a real drug versus a sugar-based, non-reactive fluid). If the basic study design is double-blind, you can have more confidence in the results

Realize it is not always easy to mimic the treatment. [This was a point I made in ‘Is Mysterious Cupping a Matter of Belief ‘ in which too many aspects of the real cupping were missing from a placebo group. The differences with the sham treatment can ‘give away’ who is in which group – experimental or control.]

C.  How many “arms” (groups) are in the study? The best design is probably a two-arm study where one group of subjects is randomly assigned to use the drug or treatment being tested, and the other group is assigned to a placebo (“placebo-controlled”). Another common two-arm design compares two different experimental drugs or treatments (“comparative study”). Sometimes there is just a single arm, where everyone uses the experimental treatment. This is the weakest design, since we have no good measure of the “placebo” effect (which might be significant).

— We stopped the interview to talk a bit more about placebos.  What they can tell you, their strength and sometimes their key to better (non-invasive) treatment. She mentioned that in one smoking cessation study, those in the placebo group had a fairly good success rate (with lifestyle and behavioral changes), only slightly less than the test subjects of the cessation drug.

[See the addendum, below Dr. North’s bio, for a thought-provoking and compelling critique she made of a couple of those studies.  This includes how the results were reported.]

Back to design. Even in a well-designed double-blind study, the significance of the results is still open to the interpretation of researchers. This final interpretation, found in “Conclusions” and “Discussion” sections of any published research report, can be extremely biased. Look for yourself. Occasionally, you may find that after reading the “Results” section of a study, and reviewing some of the data, that you are surprised by the final “Conclusions” section. You might interpret the significant points differently.

Other Observations

Dr. North explained that important information can also come from simple observations, even though it is not a formal research study. That’s the way the hair-growth drug Rogaine was “discovered.” The drug was first designed to treat high blood pressure but an “annoying side effect was soon found – namely “hair growth.” Or you and your friends may notice that using aloe juice really does help with burns. Such “anecdotal” or “accidental” evidence can lead to further investigation.

NIH has an entire division called the “National Center for Complementary and Alternative Health.” That division accepts anecdotal reports about “natural” substances or treatments and conducts well-designed studies to provide us “evidence-based” information about whatever is being evaluated. What if we want to know more about the benefits of Vitamin C? Who else is going to sponsor this? Not big Pharma. (Try explaining to your shareholders why you spent 50 million dollars on a Vitamin C study when there is no way to patent it, and thus have exclusive sales and distribution rights. So all competitors can simply wait for NIH to do the study, and then plan their own Vitamin C sales.) Unfortunately, many promising remedies will never be subjected to rigorous testing. So “don’t discount anecdotal evidence, as often it is supplying information – even if it is neither what the researchers were looking for, nor been carefully tested.” It may answer a question not being asked. Remember however, that the promise of a treatment or “cure” that has not been rigorously evaluated could be more wishful thinking than evidence-based reality.

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Tip 3 – Look for NNT (Numbers Needed to Treat)

When you assess a treatment for yourself or a loved one, you want the whole story. You need measurements that allow you to consider benefits versus risks. You are the one making the decision, and you will want to quantify the reality for your situation.

The NNT, Dr. North explained, is the answer to ‘how many people need to be treated for one (1) to have this benefit?’ It’s an obvious good thing to know. Yes, it’s also helpful to consider the subject number (as mentioned above). The larger the number of subjects, the stronger is the validation. 10% benefit in a study of 10 participants (read that as 1) could be different than 10% of 1,000 (meaning 100). But the study doesn’t do both, thus there is a question of whether results can be extrapolated to larger or smaller subject numbers, or not? It’s sometimes more difficult to evaluate and compare those numbers than the more clear NNT.

[Speaking of numbers, side effects of FDA-approved drugs must be shown in the official labelling when seen in at least 3% of test subjects. It might also be found in 3% or more of the placebo group. Dr. North makes a practical observation when she explains, “If you ask 10,000 people to take a drug for 6 months, it’s very likely that at least 3% will get a headache at some time or another. Comparatively, if 10% of the test group gets a headache, the drug is probably causing a problem.” So look at the label carefully and compare both the test and placebo group results. Don’t pay attention to that fast-talking TV drug peddler – about either the miraculous wonders, or even side effects, without delving into the facts a bit. Similar to the NNT, knowing the side effects can help you appraise benefits vs. risks. ]

What to do with Your Information? (A Bonus Tip)

Most doctors probably feel “crushed with the loads” as Dr. North phrased it. [Numerous times, I have repeated to my readers that I believe it’s impossible for health care providers to keep up with everything expected of them, or every new study.]  With some careful reading of research, especially on less common disorders, you can become as much of an expert on a particular condition (and perhaps treatment possibilities) as is the doc. Dr. North said the only thing she dislikes is when a patient comes in demanding one certain treatment without considering any options or information she may have to share.

Her suggestions are spot on. Do your own research reading, and consider your personal situation (your feelings, lifestyle, finances, etc.). Bring the literature into the doctor’s office. Don’t be confrontational, but ask for their evaluation and opinions.

[drb: Remember that like many of us, they often have fragile egos. Confrontation may be the wrong approach for YOUR success and continued relationship.]

Dr. North advises to allow it to be an opened-ended conversation. Perhaps even nicely suggest the doc may want to take a peek at your information because you “would like to have her/his opinion about its validity before making a joint decision.” That approach of sharing research, while not always practical, could be the most appropriate one with some rare, complicated or unusual maladies.

FINAL THOUGHT

Sorry to say, I am not delivering the formula here for a magic elixir or a fountain of youth (although we may be past that youth-stage at any rate). Still, these tips from Dr. North offer a solid formula for evaluating and facilitating decisions for yourself or family. They will aid in considering risks, benefits and rewards in your health care. Now, to return to the question of whether YOU have a role in this play, you DO – and you’re the star in it.

— — —

Barbara North, Ph.D., M.D., is a practicing family physician and clinical researcher with a strong commitment to wellness and women’s health. She earned her undergraduate degree from Stanford University, her Ph.D. in physiology from the University of California, her M.D. from the University of Miami, and residency training in Family Medicine at the University of California. In 1980 she co-founded “Healthworks” Inc., one of the first wellness-oriented holistic medical practice in California.

In addition to providing direct patient care, Dr. North has been committed to women’s health issues for more than 20 years. Her research activities have included clinical testing and monitoring of the safety and effectiveness of the Today Contraceptive Sponge, development of a urinary incontinence device, and evaluating treatments for vaginal infections such as yeast and bacterial vaginosis. She helped design the menstrual Softcup, and conducted the original clinical trials that demonstrated its safety and acceptability. Currently, Dr. North is focused on developing better methods of contraception for women that will also provide protection against sexually transmitted infections, including HIV.

Barbara moved to the Colestin Valley [California] from Southern California in 1993 in order to enjoy a rural life and the offerings of nearby Ashland in Southern Oregon. She continues to help care for patients in a small rural clinic in an underserved area in nearby Northern California.

Addendum – Detailed Examples of Study ‘Spin’ from Dr. North

[Note from drb: this is a (slightly edited) response Dr. North sent me regarding new research about smoking cessation I had inquired about, after our discussion of ‘tricky’ research. This is a truly informative and fascinating read, and a particularly useful benefit if you know a smoker.]

— — —

Here are some notes about the “study I was referring to regarding “Chantix” which is the most commonly used prescription pill to help smokers quit. (It is varenicline.) The references you [drb] found are for cytisine, a similar drug but has not gone through the FDA drug approval process – so not as thoroughly tested. But it is widely available online as a “natural” product – used a lot in Eastern Europe and elsewhere, and much cheaper than Chantix.”

Both drugs are good examples of how misleading clinical trials can be. For example:

Cytisine:

One study in Australia reported a 40% quit rate after one month (no placebo group). But this was after only 25 days of treatment, and just a few days after treatment stopped. Don’t we really want to know how many of these 40% continued to be non-smokers? Another study (with placebo) looked at the number of people who were still non-smokers (sustained abstinence) 12 months after treatment. With that added element of extra time in the study, the results go down to 8% (placebo about 2%). Therefore, it appears the drug may have a 6% chance of helping you quit. Yet, it also showed multiple side effects possible.

Varenicline:

All pertinent studies are summarized on the official “label” approved by the FDA and which is packaged with every prescription that is dispensed. You can also get it online (keyword “FDA label” or “prescribing information” or “package insert” for that drug). But these labels are messy. You need to look carefully to find useful information. Here is a brief walk-through.

If you were to scroll down -way down- to 6.1 for adverse events/side effects, you would notice that side effects are given as a percentage of participants, including placebo group. Then you can see how common they really are. Here, nausea is really the only relatively common problem (about 30% – 10% = 20%, or about 1 in 5 people effected). Other side effects are much less common.

Next, if you were to scroll way (way) down to 14, you find clinical trial efficacy information. First, note that “completion rate” was only 65%. That is, 35% of the people who started the study dropped out for one reason or another. We have no idea whether or not they quit smoking. A more reliable study would have a higher completion rate, or would tell us why subjects didn’t complete it. Did they move, or get pregnant, or get too busy, or what? With this information, it probably wouldn’t skew the results too much. But if they just stopped coming to the clinic for follow-up visits, it might be because they felt guilty because they started smoking again. This happens a lot in clinical studies where the participants really “want” to succeed and please the investigators. Of course, this means that the smoking quit rate is really a lot lower than reported.

Second, pay attention to the length of treatment – 12 weeks (a long time to buy the expensive drug). Subjects were then followed for an additional 40 weeks. Then the original 40% or so smoking quit rate at 12 weeks (right at the end of the treatment phase) drops to about 20% by the end of the year (when people were off the drug for 40 weeks). Placebo drops from 15% to about 8%. So again, the real statistic to look at is the quit rate at one year (20% – 8% = 12%). Thus, in the end, about 12% (roughly 1 in 10 people) were still non-smokers by the year’s end, after the 12 weeks of expensive treatment. Compare this to 8% of people who simply quit on their own. In addition, bear in mind that the people who volunteered to participate in these trials were likely to feel unable to quit on their own, and felt they needed a drug to help them. So, bottom line, by taking an expensive drug, you only improve your chance of quitting to 12% instead of 8% (when no drug used) which is still only about 1 in 10. Easy to see that some would say the drug really isn’t doing that much. Perhaps better to get into some good support groups and a stop-smoking motivating program.

More to the point here is the issue that people should evaluate apples-to-apples; rather than just pharmaceutical selling spin. They may still choose the drug; that’s okay, as long as they don’t expect miracles. The essential need is for clear information.

Realistically, I don’t think even the physician who prescribes a drug for you really looks carefully at the clinical trial results. But you can certainly ask her/him to review them with you so you can make a more informed decision. [drb emphasis.]

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