*Johnson Articles - Over the Counter Tinnitus “Remedies”: A Vulnerable Market


by Dr. Marsha Johnson, Audiologist, Portland, Oregon



Recently we have observed a strong marketing presentation of a new 'remedy' that promises to improve tinnitus. This new product has been heavily marketed in paper media such as nationwide newspapers, in popular magazines, on the radio and television. I would estimate that millions of dollars have gone into a very sophisticated advertising campaign to reach out to the one of the most vulnerable populations in the world: those who suffer from tinnitus or 'ringing in the ears'.

Why is this particular population so attractive to the business and profit minded experts who have planned this nationwide campaign? In all likelihood, because there is no 'cure' for tinnitus, and the suffering is very high for many victims. Desperate for relief, those with severe tinnitus will try just about anything.

In my 13th year of full time tinnitus and hyperacusis practice here in Portland, Oregon, I began to receive calls about this new 'product' or perhaps generously we could say, 'treatment'. Did it work? What did I know about it? Had I heard of others who had purchased the bottles of pills, for a price tag of around $200, and a full-money back guarantee in the small print? Could it work for me? The hopeful voices still resonate in my head.

That wistfulness of the sincere desire for the 'cure' is part of other groups of extremely vulnerable medical populations that I can immediately think of: pediatric cancer families or those with AIDS and others. We hear of families traveling far distances to seek out potential treatments, enrolling in studies at universities or hospitals, undergoing severe dietary or environmental alterations, etc. Often, the world of supplements is included in these dedicated attempts to shift the outcome of any terminal or incurable verdict. The refusal to give up fighting for one's life or good health is an admirable virtue and one that has been fostered throughout the long history of humankind, enabling us to adapt, survive, even thrive.

But these over the counter remedies, for the most part, refuse to play ball according to the rules, and that is the reason for this rant of mine. There have been strong scientific minds who have created potential protocols for the treatment of tinnitus since the mid 1970s in the USA, and each was subjected over time to intense securitization by the rest of the medical and scientific community, for the most part, including being subjected to outside controlled clinical testing to attempt to replicate the creator's findings. That is the gold standard of the scientific world: can the rest of us achieve or replicate what you found in your clinic-laboratory? If we can, and if can also show that a protocol does indeed prove that significantly more people benefit from the treatment than do a control group who do not receive the treatment but who believe they do, then we have a decent program. The best studies are where two groups of patients are identified and receive what seems to be identical treatments but only one group really does the 'real' one.

Good studies and trials also require that one keep detailed records pre, during and post clinical trial period. An ice bag might help ease the pain of a broken bone for a short time, but it is not a good long term solution as the pain will return once the ice is removed. A good tinnitus treatment should have positive effects that persist for a longer period of time, for example, a one-year post-treatment follow-up is another good way to judge the effectiveness of any particular program.

The problem with the tinnitus population is one of lack of attention from the medical provider in many cases. Telling the patient, you must learn to live with this symptom, can be so discouraging and disheartening, that those words alone are enough to tip a reasonably upset and concerned patient, over the edge into a state of panic and depression. When the patient hears these words, what is also heard clearly is: I cannot help you.

Just the idea then, that something might provide some relief, some improvement, some hope for a better future, will drive the average tinnitus patient to call the free toll number and order $200 worth of 'remedies'. Perhaps this might just do the trick, is the thinking, and I might be the lucky one who really does improve! Hope springs eternal and doing something, taking action towards something, is always better than doing nothing! Particularly for Americans, the can-do people, who do not accept defeat easily, having pushed their way across 3000 miles in only one hundred years and streamed into the new continent with drive and an intention to succeed.

The problem is that the FDA does not regulate the world of supplements or remedies or alternative substances very well. You can bottle up non toxic supposedly harmless chemicals or perfumes or plant materials and promote them in many different venues without any regulation whatsoever. This situation has led to widespread promotion of a variety of so-called tinnitus pills or powders, all claiming to reduce or remove the offensive auditory sound. And apparently, these are being purchased and consumed, and funds are spent every day on these potions and it is unclear as to what kind of gross sales are adding up in this particular area. I have seen these remedies at all major drug stores as well as pharmacies and health food stores and on the internet, so I would assume as a consumer that if they were not selling well, they would be removed and put into the half-off cart in the aisles. But they sit on those shelves like stalwart little soldiers, ready to do battle against the incurable tinnitus.

It is my professional opinion and wish that these companies would play 'fair' and subject their products to standard clinical trials by unprejudiced administrators or institutions, and then publish this data in peer-reviewed journals, so that we can all see if they really do work. I would like to know and there are about 45 million people in the US alone who would also really like to know.

What is well known is that there is a very strong 'placebo' effect present for the person who suffers from tinnitus and who encounters a treatment program or product or person, generally rated at about 30-40 % for most people for the initial phase. So in other words, many tinnitus sufferers feel 30-40 % better after encountering a clinician who really seems to care about their issues and who can offer some hope for improvement or relief. That initial placebo effect has a tendency to slowly diminish with time, and this is perfectly reasonable in situations where there still is no cure, and where people do improve but perhaps not quite as much as they would like or wish for. Following up with patients in a program or a protocol over a longer period of time is very important in order to capture the real outcome data.

What this really means is that, I can offer you chocolate covered raisins as a tinnitus treatment, and if I package it well, and present it properly, most patients are going to feel at least 40 % better right from the beginning. Over time, though, we can start to see what the real percentage of improvement is, and of course, it is also important to use some standardized test to rate progress. General questions, such as how are you doing, are not going to produce accurate data or provide decent and supportable results that we can use to judge a treatment program. These principles are well understood in the clinical and scientific world but are not well applied in the commercial world, where profits and sales dominate the discussions.

With regard to this new substance, I did contact their company and spoke to a person who identified himself as a person-in-the-know and with a role as the marketing-promoter of the product. I introduced myself and asked some questions about these pills. He informed me that the company was receiving thousands of phone calls each week, ordering the sixty day supply of the pills and that he was very happy with the orders and the positive results from their use. I inquired about how he thought things were going with those who bought the pills and then used them. He replied that he was sure that 85% of all of the purchasers were receiving benefit from the pills and were experiencing a significant improvement. Then I asked, how do you know it is 85%? Are you using a questionnaire or website follow up page or calling people to track their progress? No, he said, I am sure because only 15 % of all purchasers are returning their pills to us for a refund, so we 'know' that 85 % must be doing well!

Ah.

Now I have not investigated into the world of promotional marketing to see what the average rate of return from over-the-phone sales might be, but judging from my own experiences, I know that it is very challenging for me to complete the return of products that I don't like after receiving them. It is a headache to find a box, locate the return paperwork, discover how to ship it, where to send it, and then actually go to the post office or shipping company to stand in line and mail it. Then I have to keep track of the credit card charges and be sure I do get the refund credited, etc. Most of the time, I choose to recycle the dumb thing and promise myself I am not going to do that again (for a while).

I am opposed to those who prey on the vulnerable and weak amongst us, in any way, and I wish that there were some way to enforce some kind of regulation over such businesses and insist that they follow the rules of fair play, clinical trials, published peer reviewed studies, and submit themselves and their products to a thorough and moral examination before 'selling' it to the public. I am hoping Americans will endorse this point of view as well and refuse to purchase products or programs that do not have substantial research and clinical studies with peer-reviewed journal articles, to support the claims.

And yes, there is great hope that within the world of subtle vitamin and supplement adjustments, we can indeed improve health. Let's just be sure we don't get the cart in front of the horse, in the meantime.

Dr. Marsha Johnson, Audiologist
Oregon Tinnitus & Hyperacusis Treatment Clinic
Portland, Oregon

Comments, questions? Contact Dr. Marsha Johnson.

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