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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
April 1, 2017 Issue [Download PDF format]
In this issue:
New Drug Review
Pharmacists Association (HAPA) Established!
For many years it has been recognized that Hungarian-American pharmacists have been seriously under-represented within the several hundred national pharmacy organizations in the United States. Although there is a national pharmacy organization for pharmacists in almost every practice setting and of just about all national origins, races, colors, religions, and dietary preferences, not one of these organizations even mentions Hungarian-American pharmacists in their mission, vision, goals, objectives, strategic plans, and hundreds of policies. Therefore, today's announcement of the establishment of the Hungarian-American Pharmacists Association (HAPA) was not completely unexpected. When asked his view of this development, the CEO of one of the largest organizations of pharmacists, who prefers to remain anonymous, responded, "We really don't need another national association of pharmacists. We long ago ran out of combinations of letters that are used in the acronyms for the 299 current national associations, and the identity of the individual associations is often confusing. Nevertheless, to speak against the Hungarian-Americans for starting this new association might be viewed as discrimination, so I officially welcome them but, off the record, their home country needs them more than they are needed in the United States."
Staff of The Pharmacist Activist interviewed pharmacist Suzy Rosa Rassuh, CEOPVPSTSP, the chief executive officer, president, vice-president, secretary, treasurer, and spokesperson of the new association. Although she does not personally have one drop of Hungarian blood, her husband is of Hungarian descent but his identity must be protected because of the secret mission in which he is involved. Suzy observed that Hungarian-American pharmacists have been ignored for far too long but they have been willing to suffer in silence for the good of the profession, even though some of the other national organizations have become more competitive than collegial. However, she noted that several recent events had contributed to the decision to start HAPA. One was the recent establishment of the Vegetarian Pharmacists Association (VPA) which she feels is taking things too far, particularly the inclusion of broccoli in the association's official symbol. "The VPA is the 299th national pharmacy association in the United States," she observed, "and we have now been stuck on that number for more than four months. It's just time for the 300th, and who is better to achieve that milestone than Hungarian-American pharmacists?"
Suzy continued, "Most current pharmacists have no awareness of the important contributions Hungarians and Hungarian-Americans have made to the profession of pharmacy throughout the millennia." As one prominent example, she pointed to a mortar and pestle on the shelf. "Hungarians don't claim credit for the mortar," she said, "but it was a Hungarian pharmacist who invented the pestle back in the 1600s. Originally, it was called a budapestle, but the name was shortened for convenience. Today, few pharmacists know of its Hungarian origin."
When asked about the membership of HAPA, Suzy responded that there were two charter members, herself and her husband. However, with today's announcement of the founding of the Association, she expects the membership to double today and to increase exponentially thereafter. "We are very optimistic that there will be very rapid membership growth," she continued, "and that will only be partially attributable to our not having dues for membership. Once our mission, ideas, and plans are known, pharmacists will recognize the opportunity and potential that exist and will want to not only be an active participant but will also generously contribute to a mission and goals that they embrace. Pharmacists want our profession to have a strong, bold, and united voice, and when we demonstrate that HAPA is committed to that goal, they will join and support us." Suzy acknowledges that not all pharmacists would have a comfort level in being identified with an organization that some will think includes only Hungarian-Americans. However, she noted that there are many thousands of pharmacists who are wannabe Hungarians and will be pleased to join HAPA. She further noted that when membership reaches 100,000 pharmacists and student pharmacists, that the association is willing to relinquish its original name and adopt a name such as The United Pharmacists of America.
Suzy was asked about the secret mission that her husband is on. She was very careful not to reveal specifics but hinted that it has to do with a very large group of pharmacists of which few are members of any of the national associations now. They have no voice, even with their own employers, and her husband's mission is to support, organize, and unify these pharmacists who want to join an organization that offers hope and opportunity. Suzy concluded, "Check with us one year from this date. We expect to have some important and exciting news!"
NEW DRUG REVIEW:
FDA Approves Sale of Prescription Placebo*
Washington, DC – After more than four decades of testing in tandem with other drugs, placebo gained approval for prescription use from the Food and Drug Administration Monday.
"For years, scientists have been aware of the effectiveness of placebo in treating a surprisingly wide range of conditions," said Dr. Jonathan Bergen of the FDA's Center for Drug Evaluation and Research. "It was time to provide doctors with this often highly effective option."
In its most common form, placebo is a white, crystalline substance of a sandy consistency, obtained from the evaporated juice of the Saccharum officinarum plant. The FDA has approved placebo in doses ranging from 1 to 40,000 milligrams.
The long-awaited approval will allow pharmaceutical companies to market placebo in pill and liquid form. Eleven major drug companies have developed placebo tablets, the first of which, AstraZeneca's Sucrosa, hits shelves April 24.
"We couldn't be more thrilled to finally get this wonder drug out of the labs and into consumers' medicine cabinets," said Tami Erickson, a spokeswoman for AstraZeneca. "Studies show placebo to be effective in the treatment of many ailments and disorders, ranging from lower-back pain to erectile dysfunction to nausea." Pain sufferers like Margerite Kohler, who participated in a Sucrosa study in March, welcomed the FDA's approval.
"For years, I battled with strange headaches that surfaced during times of stress," Kohler said. "Doctors repeatedly turned me away empty-handed, or suggested that I try an over-the-counter pain reliever – as if that would be strong enough. Finally I heard about Sucrosa. They said, 'This will work,' and it worked. The headaches are gone."
Researchers diagnosed Kohler with Random Occasional Nonspecific Pain and Discomfort Disorder (RONPDD), a minor but surprisingly pervasive medical condition that strikes otherwise healthy adults.
RONPDD is only one of many disorders for which placebo has proven effective, Bergen said. "Placebo has been successful in the treatment of everything from lower-back pain to erectile dysfunction to nausea," Bergen said. That's the beauty, and the mystery, of placebo. It's all-purpose. Think of it like aspirin, but without any of the analgesic properties."
The FDA is expected to approve the drug for a wide range of mood disorders later this year. According to Bergen, initial research has shown placebo to be effective in the treatment of bipolar disorder, depression, dysthymia, panic disorder, post traumatic stress disorder, seasonal affective disorder, and stress.
As industry analysts predict the drug's sales will top $25 billion in the first year, the approval of placebo is expected to unleash one of the pharmaceutical industry's biggest marketing battles to date.
GlaxoSmithKline expects to have two versions of placebo on the shelves in late June. One, a 40-milligram pill called Appeasor, will be marketed to patients 55 and over, while the other, Inertra, designed for middle-aged women, is a liquid that comes in a 355-milliliter can, and is cola-flavored. Eli Lilly plans a $3 million marketing campaign for its 400-milligram tablet, Pacifex.
"All placebos are not the same," Eli Lilly spokesman Giles French said. "Pacifex is the only placebo that's green and shaped like a triangle. Pacifex: A doctor gave it to you."
Despite such ringing endorsements, some members of the medical community have spoken out against placebo's approval, saying that the drug's wide range of side effects is a cause for concern.
"Yes, placebo has benefits, but studies link it to a hundred different side effects, from lower-back pain to erectile dysfunction to nausea," drug researcher Patrick Wheeler said. "Placebo wreaked havoc all over the body with no rhyme or reason. Basically, whichever side effects were included on the questionnaire, we found in research subjects."
Added Wheeler: "We must not introduce placebo to the public until we pinpoint exactly how and why it works. The drug should never have advanced beyond the stage of animal testing, which for some reason, was totally ineffective in determining its effectiveness."
In spite of the confusing data, drug makers say placebo is safe. "The only side effect consistent in all test subjects was a negligible one – an almost imperceptible elevation in blood-glucose levels," French said. "It's unfair to the American people to withhold a drug so many of them desperately think they need."
*Reprinted with permission of The Onion.
Copyright 2017, by Onion, Inc.
"FDA Approves Sale of Prescription Placebo," The Onion: Volume 39, Issue 36, September 17, 2003.
HAPPY APRIL FOOL'S DAY!