We recently received a phone call from Dr. Mitchell S. Fineman. Dr. Fineman is a Retina Specialist in Philadelphia, PA.  He was reacting to our post titled “Eye Vitamins: Helpful or Harmful”?  Dr. Fineman admitted that the 80 mg of zinc could cause problems for those that have a certain genotype.  He then went on to say that there is the 25 mg formulation and that would be acceptable to all people with macular degeneration. However there were no studies to determine the effects of this amount of zinc in those with the particular genotype.
Here is our letter explaining our position.
May 16, 2016
 
Mitchell S. Fineman MD
840 Walnut Street
Suite 1020
Philadelphia, PA 19107
Dear Dr. Fineman:
Thank you for your call regarding the safety and efficacy of AREDS in patients with varied genetic profiles. I understand that you provide consulting services for an AREDS vitamin manufacturer and you believe that the 25mg dose of zinc is safe and effective in all patients.
We at the Macular Degeneration Association do not have any data to support that claim. We understand that nutritional supplements are not required to prove safety and efficacy of their products however the business of AREDS in AMD seems to have sidestepped the regulations required when a provider makes a medical or treatment claim for their compound. The NEI has made the medical claim for the Treatment of Intermediate AMD as if they were a non-conflicted academic institution. They have made this claim for 15 years without regulatory approval again as a non-conflicted academic institution. Companies promoting their AREDS products have hitch-hiked on the claims made by the NEI without ever needing to pursue FDA approval for the medical utility of their nutritional formulations.
Unfortunately, the NEI is conflicted. They share the ownership of the AREDS patent with industry. They share revenues from the sales of Preservision and iCaps and a significant amount of these revenues are paid directly to the lead NEI scientist. In fact, the NEI and their related scientists are conflicted commercial business partners for these patent interests. Their own data as published in AREDS report 38 shows that the AREDS formula was detrimental to patients who presented with 2 high-risk CFH alleles and 0 high-risk ARMS2 alleles. That was 19% of their patients who experienced a 78% increase in AMD progression. The NEI scientists in that publication misrepresented this data where they claimed “the AREDS supplements reduced the rate of AMD progression across all genotype groups”. That conclusion was not true! It should be retracted.
Your suggestion that the 25mg of zinc does not require any knowledge of the patient’s genotype is an extreme leap of faith. The AREDS2 study suggested that the 25mg of zinc and the 80mg were clinically equivalent. Various manufacturers now promote their formulations with 25mg and claim clinical equivalence to the 80mg patented version. Again they like to hitchhike on the NEI claim that the AREDS formulation is a clinically proven treatment for intermediate AMD.  These claims by the NEI are probably not legal but this whole business seems to skirt the regulations in the first place.
If I understand your comments, you are suggesting that the 25mg and the 80mg are clinically equivalent but you are also claiming that the 25mg is different biologically because there is no genetic data to prove harm. I must say that I am deeply disappointed in your assertion. As a senior Retina Specialist with impressive credentials, I would have hoped you would hold your oath to ‘Do No Harm’.
We, at the Macular Degeneration Association, exist to support the patients right to know. They have a right to know if these ‘treatments’ are safe and effective. Personalized medicine is not new. It is inappropriate to use broad patient data to manage all patients the same way when genetic profiles respond so differently. The published data related to the zinc interaction includes peer-reviewed publications on the study of the biological mechanism of action (not 80mg) as well as the various publications related to clinical outcomes.
If you want to make the clinical claim, you need FDA approval with data that demonstrates safety and efficacy.  You should not use your professional position to intimidate us and possibly put patients at risk. How many of your patients with wet AMD in one eye and dry AMD in the fellow eye do you care for? Are you putting their fellow eye at risk by the indiscriminate use of AREDS? They have a right to know.
Thank you for expressing your views about this very important issue.
 
Sincerely,
 
Lawrence S. Hoffheimer
Chairman
 

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