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As President Trump vows to lower prescription drugs while making the rest of the world pay its fair share - this is the beginning of the issue to solve this healthcare cost crisis. See Executive Order Fact Sheet [ [link removed] ]
As a long time practicing physician, I am concerned about the high prices of medications, especially those containing inexpensive ingredients. These exorbitant prices place an unfair burden to patients who are dependent on medications for both acute and chronic conditions.
Such prices should not occur in a free market economy, however, healthcare and the pharmaceutical industry are not free market industries.
Gone are the days when small entrepreneurs can make it in the pharmaceutical industry. The over-regulation of the healthcare industry, in the name of delivering safe products, have resulted in anticompetitive effects.
The average capitalized pre-launch R&D new drug costs vary widely; they range from $161 million to $4.54 billion (2019 US$). Anti-cancer drugs are the highest (between $944 million and $4.54 billion)
The barriers to entry are the upfront capital at risk to cover the costs of R&D, the high failure rate of prospective drugs and the lengthy FDA regulatory approval process of both the drug and the manufacturing process.
It is not uncommon to see drugs and devices come to market five years sooner in Europe than in the US. These delays deprive Americans of the use of sometimes life changing drugs, especially in cancer and other terminal illnesses.
An excellent example of how our FDA regulatory system delays the introduction of American medical technology and procedures is LASIK.
In the early 1980’s IBM scientists developed an Excimer Laser to etch computer chips.
In 1983 Stephen Trokel MD and Rangaswamy Srinivasani PHD showed that the Excimer Laser could reshape corneal tissue in animal eyes without causing significant tissue damage.
In 1986 Drs. Charles Munneryn and Stephen Trokel formed VISX to design and manufacture Excimer Lasers to correct nearsightedness and farsightedness.
VISX went through a long FDA approval process, merged with other companies and settled lawsuits with others. By 1989, the company was exporting their lasers to Europe where PRK and LASIK first started to be performed.
In 1989 Dr. Gholem Peyman was granted a US Patent for LASIK.
In the early 1990’s LASIK was being performed in Europe but not until 1995 was PRK approved by the FDA and 1999 LASIK was approved by the FDA.
The excimer laser was developed in the US, the VISK machine that delivered the laser to treat patients was also developed in the US. Yet, LASIK surgery was first performed in Europe a decade before it could be performed in the US. VISX suffered financial difficulties because of the long FDA approval process.
In the end, our FDA regulatory process took almost a decade longer than approval in Europe. Americans were denied access to this technology for almost a decade and in the end LASIK is more expensive to perform in the US.
The LASIK story is the classical story of how a slow and expensive FDA regulatory process delays the introduction of new technology and drugs in the US; this results in increased prices and deprives patients of innovations that can sometimes be life changing.
A major restructuring of the FDA approval process will lower drug and device prices while still making it profitable for companies to develop new devices and drugs.
Lowering drug prices by executive order without changing the fundamental problems is a start but it is not the long term solution to the problem.
To lower drug costs, we need to streamline our drug approval process from a cost benefit perspective, use technology including AI to facilitate drug development, and use more sophisticated data analysis to streamline the clinical trial process.
Thank you for your continued support and please reach out for assistance. Please subscribe and spread the word as we need your support to grow this message.
Dr. Michael Goldstein
The father-son team continues on so please spread the word and lets really rebuild CT and this country together in a meaningful way.

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