Recommendations for Improving the Health Care System-pharmacology

• Publication year: 2017

Recommendations for Improving the Health Care System-Pharmacology

Stephen Z. Fadem

RECOMMENDATIONS FOR IMPROVING THE HEALTH CARE SYSTEM—PHARMACOLOGY

Stephen Z. Fadem, M.D., FASN^*

Introduction

The cost of pharmaceuticals in America is beyond the reach of many citizens regardless of insurance. Of the 3 trillion dollars spent annually on U.S. health expenditures, roughly 9.8% is spent on prescription drugs. This equates to over 900 dollars per person in the U.S.¹ In order to make the system more affordable one must analyze the reasons drugs are costly and develop improved mechanisms that will reduce costs. This is a complex dilemma to discuss, but breaking it down into separate items should make it less daunting. The intent of this article is to stimulate further discussion that can ultimately result in legislation and health policy that is more constructive, preserves the safety and effectiveness of products, and reduces burdens to access that incorporate costs and availability.

I. History of the FDA

At one time a pharmaceutical agent did not need to pass any qualifying tests to be sold to consumers in America. But, the growth of a nation just emerging from the civil War forced the development of efficient methodologies in agriculture and manufacturing. The expansion in technology that fostered the industrial revolution had its byproducts in science and health, creating forerunners to products we use and enjoy today. This included chemicals, and created numerous products that had applications in medicine. Electricity revolutionized innovation and manufacturing further and as the lives of people improved, so did their desire for more and more innovation. In 1897 Felix Hoffman, a chemist at Bayer in Munich, discovered that acetylation of salicylic acid would create a medication that could be tolerated orally, would relieve pain, and lower temperature. This product became Aspirin. He also added an acetyl group to morphine, creating diacetyl morphine. When this product was given to

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subjects, they felt euphoric and strong—like heroes.² Thus, he named the product "heroin." At the time heroin was felt safer than morphine, and was sold by Bayer as a remedy for cough and for pain. It was finally banned for legitimate sale in the 1930s. At the time it was developed, there were no regulations in place to assure its safety. Those regulations evolved slowly.

Sulfanilamide (prontosil) was an antibiotic that grew out of the German dye industry, and was patented by Bayer in 1909, but not recognized as an antibiotic until the 1930s, when it was inexpensive and widely used. To improve its appeal to children, S.E. Massengill Company combined it with ethylene glycol (antifreeze). It was sold and distributed with no safety testing, and resulted in several mass deaths. This led to the passage of the Food Drug & Cosmetic Act of 1938 (21 U.S.C.), and there have been twelve amendments since then.³

The sleeping pill, thalidomide was developed in Germany and in use in Europe as a remedy for morning sickness when cases of neuritis were beginning to appear in the literature. Some users were giving birth to children with congenital absence of arms and limbs (amelia), although no connection as of yet was made. It had never been tested in pregnant women. The drug was scheduled for approval in the U.S. when executives at William S. Merrell, a drug company located in Cincinnati, were pressuring the FDA that the drug was safe and had a lower suicide rate than barbiturates. It had already been approved in Canada, Europe and Africa. However, the watchful examiner, Frances Oldham Kelsey, who had joined the FDA in 1960, recalled a publication in the medical literature that thalidomide was associated with neuritis. She stalled its approval claiming harmless sleeping pills should not cause severe neurological disorders. Meanwhile, data was emerging in Europe that confirmed the association between thalidomide and birth defects. In 1962, as a response to this tragedy, the Kefauver-Estes Amendment was enacted to assure that drugs approved by the FDA are safe and effective.⁴

The Balanced Budget Act of 1997 (Public Law 105-33) enabled Medicare beneficiaries to receive coverage through private insurance plans. These plans

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were known as Medicare+Choice or Part C plans. The Medicare Modernization Act of 2003 (MMA) (Public Law 108-173) overhauled the public health program by changing the contracting method from fiscal intermediaries to Medicare Administrative Contractors (MAC). It provided more advantages such as basic prescription coverage through Part D, but also was more restrictive with respect to provider networks. The increased costs of this program through 2015 were projected to be over a half a trillion dollars, despite limiting patient choice of physician and only partially covering medications for chronically ill patients.

The Patient Protection and Affordable Care Act (PPACA), (42 U.S.C. § 18001 (2010)) was passed to enhance health care quality, reduce costs, increase health care access and reduce disparities of care. It mandates insurance coverage for uninsured American citizens. In the past six years, users and administrators have identified opportunities within the plan to reduce its costs and burdens. To its benefit, it has reduced the number of uninsured to 10.9% from 16.4% at the time of its passage.⁵ It has been criticized in that it does not provide health care to illegal immigrants that comprise nearly one third of the existing uninsured. It is argued that denying them benefits with the exception of emergency services, forces them to abuse costlier alternatives, and ultimately shifting costs and expenses to insured beneficiaries.

Drug development has blossomed since 1938. Many discoveries like the antibiotic, penicillin, and the antihypertensive, captopril resulted from observations, but many others were the result of a systematic search for a drug that would either block or stimulate a receptor. For example, selective Beta-adrenergic blockers led to the development of propranolol, histamine 2 receptor blockade to Tagamet and Selective serotonin reuptake inhibitors (SSRIs) to Prozac. Arguably, the most important advancement was the discovery of DNA. Once the secrets of the gene were unraveled, we were able to genetically engineer products that have an unlimited amount of potential to treat and cure diseases. These products are not made in the chemical laboratory, but by genetically engineered living organisms that have had their DNA altered to specifically produce proteins for our benefit. Now, we have taken therapy to a new level by altering a gene, inserting it into a virus that targets a specific cell— a cancer cell, or a monoclonal antibody that directly modulates the immune system. The next generation of therapy will involve using the effects of exosomes, vesicles that are secreted by cells allowing them to communicate and

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stimulate each other.⁶ Stem cell therapy has the exciting potential to either rejuvenate or replace existing cells that have failed. In the future entire organs will be replaced, and prototypes that function like an ink jet printer spew cells out in an orderly fashion on a specially designed...