Statement to the FDA Committee Meeting on Medical Devices

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Good afternoon!

My name is Linda Nelson and thank you for the opportunity to speak to you today. I am from MELISA Diagnostics, in London, and I do have a disclosure to make. My company receives royalties for MELISA testing from laboratories who perform testing under license.

I have spent the last 20 years working with metal hypersensitivity. My work is based on the MELISA test, developed by my late mother, Professor Vera Stejskal, who would have loved to have be here today. I’d like to say a bit about her.

In 1968 she fled Prague, following the Soviet invasion, and was granted asylum by Sweden. She later worked for Astra Pharmaceuticals as an immunotoxicologist, and was instrumental in the development of Losec, a stomach ulcer drug, which went on become the biggest selling drug in the world.

So I like to think that Sweden got a pretty good return on accepting my mother as a refugee.

When developing Losec, she argued that pre-clinical animal testing was not suitable for predicting immune effects in humans, and a different approach was needed. She experimented with lymphocyte transformation testing but felt that LTT in its current form was not sophisticated enough.

She spent the next 10 years developing and fine-tuning the LTT method and developed a test sufficiently distinct from LTT that it was granted its own patent under the name MELISA. It could be used for many purposes but she believed its biggest use was to identify – and measure – adverse biological responses to metals.

We know that certain people react to metals such as nickel on their skin, because we can see the rash.

But, she, wondered: what happens if those metals are implanted inside their bodies? What about the reaction we can’t see?

Her work led her to discover that the inflammatory reactions caused by metal hypersensitivity didn’t just cause pain and fatigue. They could lead to severe disability. Today, there will be a great many people whose health is compromised because of undiagnosed hypersensitivity to metals.

Perhaps the most radical finding of Vera Stejskal’s research was that treatment is simple: in those patients with a diagnosed reaction to metals replacing the implant with a genuinely biocompatible alternative led to dramatic improvements in health. Without any need for drugs.

The principles of MELSA are as follows:

Lymphocytes are isolated from a blood sample and tested with metals chosen according to the patient’s exposure. The blood is incubated for five days and the lymphocyte reaction is measured by counting the uptake of tritiated thymidine by dividing lymphocytes. Next,

cells are checked using a microscope. The metal concentrations used are non-mitogenic and non-toxic in order to ensure the results are clinically relevant.

The MELISA test has now been taken by tens of thousands of patients, its used for research on inflammatory diseases at universities and it is available commercially in laboratories worldwide.

Our initial work focused on patients with symptoms related to dental fillings and crowns. MELISA can pinpoint which metal, if any, they are reacting to. The relevant metal can then be replaced with a safe alternative. In a MELISA study of 3,000 people with chronic fatigue-like symptoms, 34 per cent tested positive to nickel, and 23 per cent to inorganic mercury, which is found in amalgam silver fillings.

In a subgroup of patients who removed metals that triggered an immune response, seventy-six per cent reported a long-term health improvement – which, for chronic fatigue patients, is quite a high figure. Similar results have been obtained for patients with autoimmune diseases as well for those with fibromyalgia – these are patients who normally have no hope of recovery.

The last few years have seen rapid advances in the world of medical devices, helping people lead longer and healthier lives.

But in our work, we have identified three challenges:

A lack of awareness – amongst medical professionals and manufacturers alike –  about the risk of hypersensitivity to metal implants in a minority of patients.

In fact, those who raise concerns about their metal allergy are often told by surgeons that it won’t be a problem. With the move towards personalized medicine, a cost-effective diagnostic tool such as MELISA may establish that devices are immuno-compatible prior to surgery to ensure the best possible clinical outcomes.

Also, patients who suspect that they are suffering an adverse reaction to an implants have great trouble finding out what metals implants are made of. Detailed information is not readily available to doctors and patients alike.

The FDA Database provides a start but it is not specific enough about the alloys used.

Finally, even though there are hundreds of examples of patients making rapid and often complete recoveries after changing to immuno-compatible materials, there is surprisingly little interest from the industry in developing alternatives. We’d argue that all stakeholders – including the agency, device manufacturers, health care providers and patients – can work together to achieve better outcomes for patients.

The FDA are able to look at the whole picture; toxic reactions, and hypersensitivity-based immune reactions. We welcome the opportunity to share our science, studies and data, our aim is to use the research to change lives. This is the vision that drove my mother’s life’s work. But as I stand here today, I’m not just thinking about her.

I’m thinking about Gaynor Mitchell, who used to be a professional tennis player until she received a cobalt chromium knee implant. She knew she was allergic to nickel, but nobody took her metal allergy seriously. Her health deteriorated to the point where she had pain and widespread eczema; was depressed and finally registered as disabled, judged unable to work. Her symptoms resolved completely after the knee was revised with a custom made nickel-free device.

And then Daniel Stevens, aged only six when he had titanium rods implanted to treat his early-onset scoliosis. He developed chest pain, breathing difficulties and a severe rash. MELISA testing showed positive responses to titanium, niobium and aluminium – all present in the rods. Thanks to an open minded and innovative surgeon, his rods were removed, carbon-coated and reinserted, thereby camouflaged from his immune system. All his symptoms disappeared and, at seven years follow-up, he is still doing well.

And finally Ben Peters, who suffered a bewildering number of symptoms, including shortness of breath, headaches, fatigue, numbness in hands, urticaria and unexplained weight loss after a platinum embolization coil was fitted. It transpired that the platinum coil contained 8% tungsten to which MELISA tests showed that Ben was hypersensitive. When the coil was removed, he recovered.

These are just three people who managed their own conditions by doing their own research. In many cases, the patients, or their family, spend months searching for an answer, putting the picture together on their own. But now that we have many of the pieces, the

FDA can put the picture together, not just for the United States, but for the world.

MELISA stands ready to share our research with the FDA, or others interested in taking this research to the next level.

And I’d like to thank you again for the chance to speak to you today.

Date: Nov 13 2019