Drug system in need of remedies

Published 12:00 am Tuesday, October 11, 2011

By Dr. Ada Fisher
I repeatedly cringe when I hear politicians talk about the corruption in the way medicines are patented, made, dispensed and regulated — as if politicans aren’t part of the problem.
The regulations in place regarding medicines are keeping or delaying the entry of some onto the market because they have not met the required safety trials and had enough case studies to identify potentially hazardous side effects. The manner in which medicines are manufactured is not controlling shortages of essentials, including epinephrine, used to treat shock; potential vaccines; cancer chemotherapeutic agents and hospital drugs, mainly including sterile injectibles. The movie “Contagion” spells out clearly what problems we face if we don’t plan better.
Was production of the human papilloma vaccine (HPV) hastened since another manufacturer was threatening to encroach on the money to be made from this vaccine, as Congresswoman Michelle Bachman hints? Should only girls have been targeted since boys carry the virus? Were enough study cases done to ensure safety before the vaccine was brought to market?
In my opinion, one of the worst federal legislative moves was to give vaccine producers an exemption from liability, in the belief that this would increase competition for this business and decrease costs. So who will bear the financial burden created by those who now develop side effects from these vaccines, such as Guillain-Barre syndrome (a form of paralysis) caused by a previous swine flu vaccine? Is the government now liable for these costs, particularly when companies may not have shown due diligence in completing adequate safety research?
As our baby boomers continue to age, our problems with medication availability for those diseases associated with aging such as cancer will increase. Doxcil (AIDS, ovarian cancer, breast cancer), taxol (breast cancer, ovarian cancer), cisplastin (ovarian, bladder, lung cancers) and 5-FU (invented by one of my professors, Charles Heidelberger, who played a critical role in my medical school training) are a few of the 213 drugs all in short supply on any given day, depending on your location and facility’s connection to the manufacturing pipeline. Even propofol, a form of anesthesia that Michael Jackson had no problem acquiring, is in short supply in many hospitals. This means that doctors are being asked to play God and decisions on care are increasingly rationed by criteria that are neither universally acknowledged nor sanctioned by some medical body.
The drug pipeline slows when drugs are made into generics. Some companies may lose money that could have been shuffled to research. Along with drug company consolidations, this has forced out some research drugs that have high need value but low profitability. Designer drugs specifically targeted to diseases are costly and more difficult to make, and insurance doesn’t always want to cover them; meaning, if the government won’t pay the bill or a patient is not in a research protocol, he is not likely to get it. Third-party payers are increasingly dictating who can get what without regard to life-saving potential, curative benefit or necessary research study value. In other words, if you don’t have the money up front, you aren’t always likely to get what you need.
Is anyone asking for a full disclosure of the ties of our politicians to drug and pharmaceutical concerns and lobbyists?
Who is going to pay the bill to extend our lives even when we abuse our bodies?
Who should be the judge of what care is available?
Who should have priority for treatment?
Are we really ready for the big time of nationalized health care — more rationing of care?
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Dr. Ada M. Fisher is a physician and N.C. Republican National Committeewoman. Email: DrFisher@DrAdaMFisher.com.