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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, 2023 Issue [Download PDF format]
In this issue:
• Pfizer Submits Applications for Approval of Oral Antispike COVID-19 Vaccines: The Fantastic Research that Necessitates High Drug Prices!
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EDITORIAL:
» » » » » BREAKING NEWS!!! « « « « «
Pfizer Submits Applications for Approval of Oral Antispike COVID-19 Vaccines: The Fantastic Research that Necessitates High Drug Prices!
April 1, 2023 – New York. At a crowded Madison Square Garden press conference, the CEO of Pfizer announced that the company had just submitted applications for five similar but different COVID-19 vaccines that can be administered orally. Reading from a lengthy prepared statement, he noted: "We recognize that millions of individuals have not been immunized against the deadly COVID-19 virus for the simple reason that they don't like to be injected every two weeks with our original COVID-19 vaccine and the recommended or mandated boosters that are needed for continued protection. But our vaccines are very safe and we have only received reports of minor injection site reactions such as hematomas or hemorrhaging in the upper arm. We acknowledge that there have been rumors of blood clots that have been spread by fake news networks, but we have not been directly provided with any complaint that has been accompanied by the actual clotted blood or even a photograph of it. As scientists, we recognize that if there is no documentation, it didn't happen. However, all these irresponsible rumors are no longer pertinent as our oral vaccines will be a pleasure to take just once a day. Although they won't protect you personally against the virus, they will prevent its transmission to your loved ones, the community, and the world. We are confident that our benefactors in the federal government will recognize the value of our new vaccines and mandate that every individual uses one of them as part of their civic responsibility.
"We initially thought we would be ready to submit the applications for FDA approval for our oral vaccines two months ago, but we encountered some unanticipated delays. As a company with thousands of employees, we had assumed that diversity would be achieved through our normal hiring practices. However, several of our woke, I mean conscientious, employees thought that we were not doing enough to meet the expectations of the federal government, and particularly the FDA from whom we were requesting urgent, priority, expedited approval of our applications for our oral vaccines. Our media relations staff hastily developed a press release to emphasize Pfizer's commitment to DIE, as well as our commitment to increase our profits, salaries, and value of our stock shares purchased by our beloved investors. There were several immediate responses that suggested that DIE was being misinterpreted and, at the least, it should be revised to DEI. Well, that was just the beginning! Others stated that there must be a commitment to LGBTQIA, and a few employees insisted that we must not ignore the CDEFHJKMNOPRSUVWXYZ groups. It quickly became apparent that there were more groups that wished to be recognized than there were letters in the alphabet. At this point we realized that we needed to retain a consultant group so that I and other executives would not be faulted for adopting whatever approach they recommended. The consultants initially considered adding Greek letters, but abandoned that idea because of potential confusion with the names of the multiple variants of the COVID virus. Their conclusion, which Pfizer is proud to adopt, is to follow the capital letter with whatever number of lower case letters are needed. For example, those of Irish descent would use 'Ir' and those of Italian descent would use 'It.' Most employees seem pleased with this approach although there are several whose prejudices and intolerance will never be resolved.
"But those distractions and delays are now behind us and we are excited to share our information and plans for our oral COVID-19 vaccines. In the way of background, almost all of us in the science community are in agreement that the COVID-19 virus that is responsible for the pandemic did not originate in some batty source, but rather in the laboratories in the Wuhan Institute of Virology (WIV), that had insufficient safeguards to prevent lab leaks. We also know that the virus has a spike protein although it is less clear whether that is a component of the natural virus or whether it was added as part of the gain-of-function research in WIV that was generously supported by Dr. Fauci and the National Institutes of Health using our tax dollars. (You can count on us at Pfizer to be fully transparent). When an individual is exposed to and contracts this super and highly contagious form of the virus, the spike of the virus is broken down to thousands of spikettes that are rapidly distributed to every system and crevice of the body. This is why so many different symptoms have been attributed to COVID-19, as well as long-COVID, intermediate-COVID, and short-COVID. Fortunately, our brilliant Pfizer scientists were up to the challenge and quickly developed the first COVID-19 vaccine to be approved but must be administered as an injection. The affinity of the vaccine for the virus and the protection provided was demonstrated in at least 50 of our mildly-ill lab staff for whom the pattern of adverse events attributed to the vaccine were almost exactly the same as the symptoms of the infection. These findings confirmed that the vaccine was distributed to virtually all of the systems and crevices in the body occupied by the virus spikettes. Almost all of our lab workers fully recovered within 6 months, and those who didn't were quickly diagnosed by our company physician as having influenza virus infection against which they had not been immunized.
"The next step in our research planning was to address the challenge presented by the need for frequent and often painful injections of the vaccine which had become recognized as the primary reasons for vaccine hesitancy and anti-vaxxing. Through advances in technology, our scientists were able to reduce the particle size of the virus spikettes to form nanospikettes that, following oral administration, were rapidly absorbed from the gastrointestinal tract and distributed via the circulation. This technological advance also provides a faster onset of action against the COVID virus, compared with our earlier vaccine that must be administered by injection. Although the oral vaccine must be administered every day and is more costly, we anticipate that individuals will be pleased to avoid painful injections, particularly since the government is generously assuming the cost of the vaccine. (Our tax dollars at work).
"The effectiveness of our scientists in using nanotechnology to enable oral administration of the vaccine also provided multiple opportunities for different flavors and other formulation innovations, particularly for use in children and the elderly. We had not anticipated that it would be difficult to decide among the numerous options, but a consensus could not be reached on a timely basis, and the debate about preferred flavors and innovations became intense and argumentative. At this point one scientist who was known to colleagues for praying alone in the local cathedral during lunch breaks, respectfully asked. 'What would Jesus do?' However, this failed to solve the stalemate as each of the scientists in the lab was confident that Jesus would support her or his preference. A company-wide survey was then conducted but this only resulted in even more possible formulation options and more ideas as to what Jesus would prefer.
"By this time, our Board of Directors was becoming increasingly impatient by the delay in bringing the anticipated blockbuster products to market and rejoicing in the next financial windfall. They recommended that we ask the clinicians in Israel who had conducted the first clinical evaluations of the oral vaccines for their opinions. However, almost to a person, they responded, 'Who is Jesus?' At this point I made the executive decision to have multiple formulation options that would provide the added benefit of people thinking they still had some choice when the government mandated they take the vaccine.
"To help contain costs and assure greater profits, the manufacturing of the formulations was outsourced to our subsidiary Pfizzer in India and our subsidiary Pfizzle in China, and produced according to our rigid specifications. The first formulation, uncoated tablets, was produced in India and the first batch was shipped to our laboratories in New York for quality control validation. As the laboratory technician was performing the usually routine dissolution test in simulated gastric fluid, he observed what appeared to be slow movement of the tablet across the bottom of the flask. He gathered some of his colleagues and they projected a magnified image of the tablet on a screen in the front of the lab. They observed some short protrusions from the bottom of the tablet and confirmed that it was slowly moving. Upon removal of the still-intact tablet from the flask they discovered a centipede embedded in the tablet matrix. Although centipedes are a dietary delicacy in some parts of India, we knew this would be unacceptable in most countries. When we contacted our colleagues at Pfizzer in India, we were shocked to learn that the community was overrun with centipedes and that it would be impossible to avoid some minor contamination. At this point, I made another executive decision to have the tablets film-coated and to name the product Antispike-T.
"The second formulation, Antispike-S, is a tutti-frutti-flavored suspension that is also formulated at Pfizzer. Children in the clinical study just love this product and look forward to taking it every day. Because we fully expect that the FDA will approve/mandate the vaccine for even newborn babies, we have confirmed that the suspension is compatible with breast milk, notwithstanding the small strawberry-colored specks that have crystallized from the flavoring material without affecting the effectiveness of the vaccine.
"Our Antispike-F (fizzy) effervescent tablets are formulated like Alka-Seltzer, but without the aspirin. However, the product development people at Pfizzer have encountered difficulty in developing this formulation, and its availability may be delayed. The tablets include the vaccine, sodium bicarbonate, citric acid, and grape flavoring, and when placed in a glass of water, quickly effervesce and the ingredients dissolve. At least that is what is supposed to happen. With the first batch was tested, the tablets just sank to the bottom of the glass and stayed there. The technician had difficulty in removing them because they adhered to the glass, but he did so and provided them to the chemist for analysis. The labs were being renovated and it was discovered that some of the insoluble construction materials had been accidentally used instead of the intended tablet filler. The error was corrected in preparing the second batch of tablets and they quickly fizzed and dissolved when placed in water. With an abundance of caution, the chemist decided to check the composition of these tablets also, and determined that they contained nitrosamines in a concentration of 46.3%. Although small amounts of nitrosamines form when grilling steaks and they have never really been proven to cause cancer, we recognized there was a remote possibility that the FDA would find out about them so this formulation is on hold until we can find out how the nitrosamines got in the product and how we can lower the content to less than 10%. You can count on Pfizzer and Pfizer to not distribute a product before its time.
"Because of these mistakes, I made another executive decision to have our subsidiary Pfizzle in China manufacture the next three formulations, particularly since they have had extensive experience with anticoagulants. Although we still have not been able to document even one confirmed case of clotting with our injectable vaccine, we have been surprised by the number of people who think this is a risk. This is most likely due to artist renderings of thick stringy structures in tubes that look like blood vessels that often appear in television news programs. To allay these concerns, we decided to have formulation options that include an anticoagulant with the vaccine. Antispike-H tablets were formulated to include the vaccine with heparin but the labels stated that there was 20 mg of heparin in each tablet. We recognized that might raise suspicions because the potency and dosage of heparin products is designated in units rather than milligrams. In addition, heparin is not likely to be absorbed following oral administration and we have made a decision to not distribute this product in the United States.
"This decision was easy because it provides the opportunity to combine the vaccine with the most effective anticoagulant that we happen to co-market with another company. Antispike-E tablets contain ELIQUIS with the vaccine. Anyone who has even heard the name Eliquis knows this is a very costly drug so it must be good and worth the higher cost. We anticipate that the revenue from sales of Antispike-E will be more than that for all the other Antispike products combined, and most probably will even exceed the revenue of the previous all-time record-holder – our injectable COVID-19 vaccine.
"Our one other oral product is Antispike-O effervescent tablets. This will be the ideal product for the vaccine hesitant, anti-vaxxers, and others who for some reason do not wish to obey mandates. Because there are one or two pharmacists who study drug names to attempt to determine their origin or meaning, we have only identified that 'O' is for Obecalp in small type on the reverse side of the label so that we comply with ethical and truth-in-labeling standards. Individuals can be absolutely assured that they will not experience any vaccine adverse events, and because the tablets are fizzing in the glass of water, they will think that something good and protective will happen when they swallow the liquid. We were tempted to charge the same price for Antispike-O (with one less ingredient) and Antispike-F, but our conscience (aka, our attorney) would not let us do it. Accordingly, there will be a generous rebate for prescription refills for Antispike-O.
"The excitement continues as we submit the applications for our oral vaccine products to the FDA for its anticipated emergency authorization approval within the next week. Because of the urgency for the wide availability and use of these vaccines, we anticipate full FDA approval by the end of the month.
"In the meantime our unsurpassed research programs continue 24/7. We are fully engaged in gain-of-function (GOF), I mean gain-of-toxicity (GOT) research and there is, of course, an important difference. It is essential that the origin of the virus and its deadly actions, as well as the potential toxicity of the vaccines be completely understood. Because the Chinese Communist Party will reveal no information, and the statements of U.S. government officials and agencies are always conflicting, Pfizer has accepted the responsibility of doing the necessary research. We already have two more oral vaccines in our research pipeline, Antispike-N that also includes nitroglycerin for individuals who experience acute chest pain following the administration of a vaccine dose, and Antispike-A that also includes amphetamine for individuals who experience abrupt fatigue or narcolepsy following vaccine administration. We are already negotiating with the DEA to avoid having the latter product classified as a controlled substance because it would just be one more reason for individuals to be hesitant to obey the mandates. And just in case viral infections occur and become serious even following daily use of our oral vaccines, one should immediately start a 5-day course of Paxlovid (prescription or otherwise). If symptoms don't resolve within 5 days, take another 5-day course of treatment, up to the maximum of 50 days of treatment. I recognize that more than 5 days of treatment is off-label, but as CEO I have immunity in exercising my best business judgment which is not within the scope of the FDA's authority.
"Our research program is already developing the COVID-24 virus, I mean the new booster vaccines that will be needed to protect against the virus variants anticipated to be most prevalent in 2024. It is thought that the deadliest variants of the virus emerge in 5-year cycles, and Pfizer wants to be ahead of the curve. So whatever you hear about our research, remember that Pfizer is committed to protect your health and our profits. And let it also be clear that Pfizer acquires its revenues by charging necessary but very high prices for our products, and we don't receive any tax dollars, at least directly, or NIH grants from Dr. Fauci. We also go the next step in protecting our prolific profits and our shareholders by only working with banks in Ireland.
"There is another decision that I must disclose as part of our commitment to be fully transparent. I have worked to the point of exhaustion during the last 5 years, and I must now reserve my expertise and energy for the most important decisions and responsibilities, such as fighting a hostile takeover attempt by CVS. Therefore, I will no longer be personally appearing in these press conferences. To identify a new spokesperson, we first contacted Tucker Carlson and made him an offer that we thought he couldn't refuse. However, to our surprise, he declined our offer because he couldn't do so and maintain a clear conscience, a concept with which we are not familiar. But it is all for the best as we then discovered the ideal spokesperson right within our own building. I am pleased to announce that former FDA Commissioner Dr. Scott Gottlieb will be our new spokesperson. When Dr. Gottlieb stepped down from his FDA position, voluntarily I should add, we happened to have a vacancy on the Pfizer Board of Directors that he enthusiastically accepted and, in just a short period of time, he has become our most publicly visible Board member.
"Although not many people are aware of it, but again in the interest of full transparency, I would share that Dr. Gottlieb was guilt-stricken for a number of minutes after leaving the FDA because he had the authority, but did not use it, to ban the sale of cigarettes and other tobacco products and save the lives of 480,000 Americans each year for the foreseeable future. Fortunately, the ideal remedy resided in our own line of products and Dr. Gottlieb has become the most enthusiastic advocate of us all in promoting Chantix. It is like having your cake and eating it too -- let the toxic tobacco products remain on the market and increase Pfizer's bottom line and stock value by selling more Chantix, which by the way should be available without a prescription and Dr. Gottlieb will be working on that.
"We always welcome your positive news coverage and your constructive questions and feedback. Regrettably, we don't have any time to take questions. If you have positive ideas and suggestions for us, please send them to compliments@pfizer.com; if you have criticisms, please send them to complaints@moderna.com.
"In conclusion we pledge that you can depend on the facts and fine pharmaceuticals from Pfizer in support of your health! In spite of what the FDA says, do not be fooled by the cheap allegedly equivalent generic formulations of our products that are often adulterated, contaminated, have large variations from the stated potency, and are dangerous.
"Happy April Fools' Day from all of us at Pfizer, Pfizzer, and Pfizzle!"
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