Pfizer employees must be fully vaccinated against COVID-19 in coming weeks or face termination. The Pharma company is mandating all U.S.-based employees and contractors be fully vaccinated by Nov. 15, according to an internal Sept. 21 memo obtained Friday by CBS affiliate, News Channel 3. The requirement does not apply to those with a religious or medical exemptions, according to the outlet. Those who do not abide by the requirement and do not have an exemption could get the boot, according to the memo from Nicole Shaffer, senior Director of Colleague Wellness at Pfizer. The company — whose mR...
There were many times, I'm sure, when my mother was disappointed in me, but one memory is seared into my brain like rice scorched into the bottom of a forgotten pot on the stove. Imagine it's your mom's favorite pot. The one she inherited from the good grandmother.
I was 16, and for reasons I can't remember, I had to get a blood test at the hospital where Mom worked as a nurse's aide. This was the age when I was diagnosed with severe asthma, so maybe this was a test to see if I was going to die. I may be exaggerating.
Anyway, this blood test was a very big deal to both of us for different reasons.
For Mom, this was a chance to introduce her oldest daughter to dozens of co-workers before I left for college and immediately forgot the names of the parents who raised me (Mom's fear).
For teenage me, it was the daylight version of a slasher film, in which someone you trust coaxes you down the hallway and into the arms of the guy wielding a pickax. You might call it a needle.
Seventeen years earlier, my mother had to give up her dream of becoming a nurse because she became pregnant with me. She never put it like that. I was a gift from God, she always said, who helped her see that she was destined to be a mother.
Still, wouldn't it be nice, she often added, if her oldest daughter decided it would be her dream come true to become a nurse? Purely coincidentally, of course.
I was all in, until the day we went for that blood test. Again, I don't remember the details, but that never mattered as long as Mom was alive, because she remembered it with the accuracy of that witness to multiple crimes who nails the police lineup every time.
Apparently, it took a lot of negotiating to get me into the one-armed chair. After the needle pierced my skin, I started to hyperventilate. "What a performance," Mom said every single time we talked about this, which was often. For decades.
After the blood test was over, I reportedly stood up and said, ever so softly, "Uh-oh." Down I went, taking Mom with me.
Here comes the part I do remember: We're in the car in our driveway, after a silent trip home. Mom cuts the engine, looks at my bandaged forehead and says, "Maybe Leslie will be the nurse."
And God said, "It is done."
My sister Les became the nurse Mom had always wanted to be.
I still hate needles. Two years ago, a friend started describing over dinner how she loves to watch her blood shoot up the line when she donates it. I ended up with my head between my knees to keep from fainting right there in the restaurant. "Just looking for an earring," I said.
"Where is this going?" you may wonder.
Come with me. I'll drive.
We're sitting in my Jeep, made by union workers in Ohio, as we turn into the county fairgrounds. We are joining dozens of other cars slowly streaming in front of us and behind us. Remember that last scene in "Field of Dreams," when that long line of cars is winding its way to the magical baseball field in the cornfield? It's like that.
Friendly people wearing masks and smiling eyes are welcoming us, nodding hello to you, my passenger, as they check my license. One nice woman directs me to veer right because, being my mother's daughter, I have already printed my medical form and filled it out before leaving the house.
The sun is shining (it really was), and something is happening inside me as I slowly pull into what looks like a 4-H barn at the county fair. It's a feeling I've never had before.
I can't wait to get that shot.
I lower my car window, shove up my sleeve and offer it to the masked man with the needle. "Thank you," I tell him as he injects my first dose of the Moderna vaccine. "Thank you, thank you."
A week from today, I will be 28 hours out from my second dose of this vaccine for COVID-19. I may experience some side effects, but I can't wait to get that next shot. I'll let you know how it goes.
If Mom were here, she'd tell you that if her oldest daughter can get this shot, so can you.
Then she'd tell you a story. You know the one.
Connie Schultz is a Pulitzer Prize-winning columnist and professional in residence at Kent State University's school of journalism. She is the author of two non-fiction books, including "...and His Lovely Wife," which chronicled the successful race of her husband, Sherrod Brown, for the U.S. Senate. She is also the author of The New York Times bestselling novel, The Daughters of Erietown. To find out more about Connie Schultz (email@example.com) and read her past columns, please visit the Creators Syndicate webpage at www.creators.com
Reprinted with permission from Daily Kos
On the seventh day of his administration, Joe Biden stepped out to announce that he has purchased another 100 million doses of vaccine each from both Pfizer and Moderna. These doses won't arrive until summer, but added to the vaccine already purchased—and potential doses coming soon from Johnson & Johnson or others—there should be enough vaccine to get every American over 16 vaccinated. And then some.
As Biden said in his brief appearance, "I hope by the end of the summer we have too much vaccine left over. We have too much supplies left over. That's not my worry."
But Biden was also blunt that the nation is facing enormous challenges right now. Cases of COVID-19 are still very high. Both vaccines and supplies are in short supply. New variants of the SARS-CoV-2 virus are spreading rapidly, threatening to bring another spike of cases and strain every point of the nation's ability to fight the pandemic. Biden admitted that getting the vaccine was just one step, but he committed to making sure that the rest of the challenge was met.
Getting everyone vaccinated by summer or early fall means not just coming up with more doses, but increasing the rate of vaccination by two to three times. Biden pledged to meet that challenge. As first steps, he notified states that starting next week the number of doses going out will increase from about 8.5 million to 10 million a week. He also pledged to be clear to states about quantities they will be receiving so that each state can better plan how to efficiently distribute vaccine.
Biden mentioned several times his intuition to use the Defense Production Act, not just to secure more vaccine, but to make sure there are adequate supplies. That includes the vials and syringes needed for vaccination, personal protective equipment needed to protect healthcare workers, and swabs and reagents needed for testing.
Biden also continued to emphasize that in the near term, masks are a more valuable tool than vaccines. He repeated projections that having a high rate of mask-wearing just between now and April can save over 50,000 lives, and he took a swipe at Republicans who sneered at the idea of Biden's 100-day mask order, saying that real patriots wear a mask to protect their fellow citizens.
On travel restrictions, Biden made it clear that he wants universal testing of all travelers coming into the United States before they've left their origins, and isolation of travelers on arrival. This level of restriction is perhaps the only step that would work considering that numerous variants are now being carried around the world and bans against specific nations or regions have limited utility.
Overall, the theme of the appearance continues Biden's absolute commitment to address the COVID-19 crisis head on, and deliver for America the kind of effort that should have been there … over 400,000 lives ago.
Jeff Danziger lives in New York City. He is represented by CWS Syndicate and the Washington Post Writers Group. He is the recipient of the Herblock Prize and the Thomas Nast (Landau) Prize. He served in the US Army in Vietnam and was awarded the Bronze Star and the Air Medal. He has published eleven books of cartoons and one novel. Visit him at DanzigerCartoons.
Reprinted with permission from ProPublica
Despite President Donald Trump's promises of a vaccine next month and pundits' speculation about how an “October surprise" could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you'll see, it's a long shot in 38 days.
There are three key milestones that must be met:
- A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer's trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren't so sure it'll be that soon or whether the results will be conclusive.
- Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately.
- The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it'll be a late 2020 availability," McClellan said.
None of this is to say that Trump couldn't suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses") is to see if there's already enough evidence to conclude that the vaccine either works or doesn't.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it's probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary," said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer's trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn't work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts' prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October," CEO Albert Bourla said Sept. 13 on CBS' “Face the Nation."
The key thing we don't know is how fast people in Pfizer's trial are getting sick. The trial doesn't intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It's possible that the thousands of people who signed up for Pfizer's study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer's trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer's first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan's model.
“When the trials started there were a lot more cases in the U.S. at that time," said Dr. Vamil Divan, an analyst at the bank Mizuho. “That's a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?"
To protect the integrity of trials like this, the drugmakers running them aren't supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They're making projections based on how rapidly they're accruing data, and they probably know the total number of events," said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices," she added.
In a statement, Pfizer said that it expects results “as early as the end of October" based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible."
“Having said that," the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial."
It's highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts' model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna's chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case" for the first look at Moderna's results. (ProPublica's board chairman, Paul Sagan, is a member of Moderna's board and a company stockholder.)
Other developers are further behind. AstraZeneca's trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it's unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine's effectiveness, it's very difficult to argue anything is ethical other than making it available to those most at risk," Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it's also very difficult to make the argument that you should do anything that undermines public trust. That's one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process."
Once Pfizer gets results, it's poised to seek the FDA's go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer's CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready," Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic's duration — during the declared “emergency" period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing" the disease and “the known and potential benefits of the product … outweigh the known and potential risks." In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information," an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application."
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis," Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer's board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick."
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine," Gottlieb added.
The FDA will thoroughly review the application, and that'll take a while.
Once the FDA receives a company's submission, the agency's review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA's former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop" that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers' manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company's application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it's an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we're not, like, holding something in and sweeping something under the rug? Well, the way they're going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting," Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It'll be critical for people to see what's in the briefing packages, they'll be able to see the discussion among an impartial group of advisers, they'll see the committee recommendation and they'll see the public dialogue that will take place at that committee."
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee's recommendations, the votes are public.
“It protects against political interference — it's important," Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don't have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written," Dr. Paul Spearman, director of infectious diseases at Cincinnati Children's Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain."
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer's first look.
“It's hard for me to say with these small numbers will we have meaningful data to make a decision on," Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be."
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it's possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It's not simply a matter of saying we will EUA this product," Kurilla said. “We have to be very careful to define what it is we're trying to address."
Dr. Paul Offit, director of the vaccine education center at the Children's Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee's advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It's unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it's not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won't need long-term storage, because they'll all be used quickly, so companies won't need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency's review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people's arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
- If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies' own standards to prove it works. If they unexpectedly change their schedules or the standards, that's concerning.
- If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency's leaders reject the committee's advice, it would be a sign that they're acting under political pressure without scientific support.
- If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks' decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn's call.
- If FDA officials quit. Marks has said he'd resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that's taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn't feel confident in taking it.
“A vaccine only works if it's safe, effective and administered," meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn't represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal."
It's unlikely we'll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.
It’s one thing for Pfizer to renounce its U.S. citizenship, moving its official residence to Dublin, Ireland, as a tax dodge — all the while continuing to run the business in the United States. That disgusting tactic happens to be disgustingly legal, thanks to our indolent Congress and its failure to fix the corporate tax laws.
It’s quite another to insult the public with blatant phoniness that avoiding billions in U.S. taxes gives the company “the strength to research, discover and deliver more medicines and therapies to more people around the world.” Those are the words of Pfizer’s chief executive, Ian Read, an accountant by training.
The Pfizer deal involves a merger with a much smaller Allergan, an Ireland-based company that happens to do its business in New Jersey. Wall Street analysts scoffed at the notion that the deal had any purpose other than to let the company avoid billions in U.S. taxes — billions that other American taxpayers will have to replace.
Since Read took the helm in 2010, Pfizer has slashed its research and development budget.
We assume the company will expect the United States to continue subsidizing research through the taxpayer-supported National Institutes of Health. We assume it wants the U.S. government to continue defending its intellectual property rights.
Pfizer made headlines more than a decade ago when it persuaded the city of New London, Connecticut, to use eminent domain to seize a working-class neighborhood around its shiny new headquarters — and replace it with an upscale shopping, hotel and office complex more to the company’s liking. Actually, it was a condition of its move to the city, according to The Day in New London.
The Supreme Court gave the controversial plan a green light in 2005. Four years later, Pfizer abandoned New London.
Yes, the drugmakers know how to make government work for them. Their lobbying group, the Pharmaceutical Research and Manufacturers of America, leads efforts to ensure that Americans pay far more for their products than citizens of other countries.
The drugmakers’ crowning achievement was getting a Republican-controlled Congress to write a Medicare drug benefit law to their specifications. While funneling billions in taxpayer subsidies toward helping the elderly buy drugs, it forbade the U.S. government to negotiate the prices on behalf of said taxpayers.
No other Western country lets drug companies charge whatever they think they can get away with. This is why the government of Norway pays about $460 for an injection of the asthma drug Xolair and our Medicare pays about $860.
(Pfizer also lobbied against proposals to let Americans buy their drugs from other countries at these lower prices.)
These conversations always circle back to the drugmakers’ argument that Americans must pay their price to cover the high expense of developing wonderful life-enhancing products.
We can close that circle by asking: To the extent that high U.S. drug prices support research and development benefiting the world, why are Americans the only ones footing the bills?
The drugmakers don’t talk much about that publicly for a very simple reason. It is not in the interests of their executives and investors to stop Americans from playing the chump. If they can get the job done by writing checks to obedient U.S. politicians and the chumps keep re-electing them, why make trouble for themselves?
In a recent annual report, Read told shareholders of Pfizer’s desire to earn “greater respect from the public,” which entails “acting as a respectable corporate citizen.”
Read may have reason to take the American public for easily deceived children. Basic decency, however, demands that he limit such thoughts to private dinner parties.
Follow Froma Harrop on Twitter @FromaHarrop. She can be reached at firstname.lastname@example.org. To find out more about Froma Harrop and read features by other Creators writers and cartoonists, visit the Creators Web page at www.creators.com. COPYRIGHT 2015 CREATORS.COM
The Pfizer logo is seen at their world headquarters in New York April 28, 2014. REUTERS/Andrew Kelly
New York (AFP) – U.S. drugmaker Pfizer said on Monday it would abandon its controversial bid to acquire British rival AstraZeneca after its final $117-billion offer was rejected last week.
“Following the AstraZeneca board’s rejection of the proposal, Pfizer announces that it does not intend to make an offer for AstraZeneca,” the New York-based company said in a statement.
The announcement put an end to a long-running saga that drew widespread attention over fears that British jobs and research capability would be lost and accusations that the tie-up was a cynical ploy by Pfizer to pay less tax.
Pfizer had said that the combined company would deliver an expanded product pipeline, deep potential cost cuts and significant tax savings.
“We continue to believe that our final proposal was compelling and represented full value for AstraZeneca based on the information that was available to us,” said Ian Read, chairman and CEO of Pfizer in the statement.
Pfizer’s proposal also included a controversial plan to re-domicile the combined company in Britain for tax purposes, in a move that would help it avoid paying billions of dollars in tax to the US government.
Pfizer’s play for AstraZeneca comes as global pharmaceutical giants maneuver to cope with lost revenues from public sector cutbacks in health care, and patent expirations.
AFP Photo/Mario Tama
New York (AFP) – Pharmaceutical giant Pfizer Tuesday announced that it settled patent litigation against Teva Pharmaceuticals over the sale of a generic version of blockbuster drug Viagra in the United States.
The settlement means Israel-based Teva “will be allowed to launch a generic version of Viagra in the U.S. on December 11, 2017 or earlier under certain circumstances,” Pfizer said in a statement.
“Teva will pay Pfizer a royalty for a license to produce its generic version,” Pfizer said.
Other terms of the agreement were confidential.
Patents for Viagra, which treats erectile dysfunction, expire in April 2020, Pfizer said.
In June 2010, Pfizer lost its patent in Brazil to exclusively sell the drug. Pfizer’s patent for Viagra has also expired in Europe and Japan.
The U.S. Food and Drug Administration has granted tentative approval for Teva’s generic version of Viagra, said Teva, which is the world’s biggest generic drug maker.
Photo: Waleed Alzuhair via Flickr
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