Dumb and Dumber... For How Long?
Segment # 031
I need to spend some time making fun of my indignant outrage at Big Pharm’s takeover of the US healthcare system, the media, and yes our political system. Maybe if I had paid a little more attention the past 50 years it would have occurred to me that our fellow citizens have been selling us out for a very long time. It is obvious that given the chance human nature says the tempted will usually do the wrong thing.. and there is no limit to wrong doing.. human life.. suffering of all kinds are really not a big deal. As a conservative it pains me to say that small victories were achieved by a combination of private citizens and government regulation and punishment. We can’t after many historical greed inspired tragedies, assume that people will do the right thing. They just won’t..
Pfizer revenue and profits soar on its Covid vaccine business
New York (CNN Business)Pfizer reported that earnings and sales more than doubled in the past quarter, and it raised its outlook for results the full year, thanks greatly to its Covid-19 vaccine.
The company reported adjusted earnings of $7.7 billion, up 133% from a year earlier. Revenue soared to $24.1 billion, up 134%. Both easily cleared results forecast by analysts.
The vaccine business alone was responsible for more than 60% of the company's sales, as vaccine revenue rose to $14.6 billion from only $1.7 billion a year earlier. The company said its Covid vaccine sales accounted for $13 billion of that revenue. Revenue outside of its Covid vaccine business was up a far more modest 7%.
This year, the Covid vaccine has brought in revenue of $24.3 billion. And Pfizer said it expects a total of $36 billion from the vaccine for all of 2021 -- nearly $12 billion more in revenue the final quarter of the year. And it said based on contracts it now has signed it expects revenue $29 billion from the Covid vaccine in 2022. And that's not necessarily all it will bring in.
"We continue to engage with governments regarding potential additional orders for 2022," said the companu.
The company said it now expects full-year 2021 revenue of between $81 billion to $82 billion, up $2 billion from its earlier guidance. It also raised its earnings per share outlook by about 3% to 5% above what it had been expected to earn.
"While we are proud of our financial performance, we are even more proud of what these financial results represent in terms of the positive impact we are having on human lives around the world," said CEO Albert Bourla in his prepared remarks for investors.
About 67% of the total US population has had a least one dose of a Covid vaccine, and 58% are fully vaccinated, according to data tracked by the Mayo Clinic. So there is still significant vaccination doses that can be administered, especially to children, many of whom are still not approved to receive the vaccine.
The US Food and Drug Administration on Friday granted emergency use authorization for the Covid-19 vaccine from Pfizer for children ages 5 to 11. Final approval of the vaccine for children is up to the director of the Centers for Disease Control, Dr. Rochelle Walensky. The CDC's vaccine advisory committee is set to meet Tuesday, and the younger children could start to get the vaccine within days.
https://www.cnn.com/2021/11/02/business/pfizer-earnings/index.html
The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?
I cover news on drugs and R&D in the pharma industry
This article is more than 3 years old.
Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three quarters of the FDA’s budget used for the drug review process. This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.
How did we ever get to the point where private industry is providing so much support for a federal agency? Actually, this all began about 25 years ago, when the U.S. was facing a “drug lag”. Because of a lack of resources at the FDA, drugs were being approved at a much slower rate here than in Europe. More than half of all drugs approved in the U.S. had been approved in Europe more than a year earlier. Patients, advocacy groups, pharmaceutical companies, and physicians were all concerned that important new medicines were being denied to Americans.
To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992–a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues, known as “user fees”, were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. In fact, one of the biggest years of NDA approvals occurred in 1996 when the FDA approved 56 new products, largely the result of working through this backlog.
As a concession to agreeing to these “user fees”, the pharmaceutical industry was promised that the FDA would reduce review times of NDAs to 12 months for those that were considered “standard” applications and to 6 months for priority applications that involved significant advances over existing treatments. The PDUFA Act has since been repeatedly renewed with PDUFA VI passing last year. And, as would be expected, “user fees” have gone up over the years, from $208,000 per NDA in 1995 to a whopping $2,421,495 for fiscal year 2018. Keep in mind that the industry didn’t exactly have a choice in this matter. PDUFA was a decision by Congress to make the pharmaceutical industry pay for the work it was generating at the FDA–work being done to get new medicines to Americans. It wouldn’t be surprising to see Congress eventually transfer 100% of the costs of FDA reviews of NDAs to industry.
One might think that, given the dependence of the FDA on “user fees”, NDA approvals would be a “rubber stamp” process one that was simply a formality. But that’s not the case. As Chen points out, one in five NDAs were rejected by the FDA in 2017 and that doesn’t include those drugs that are pulled in late stage development because they don’t meet the hurdles set by the FDA to justify approval. This failure rate doesn’t support Chen’s concerns about industry favoritism on the part of the FDA.
However, Chen’s concern about the rapid approval on drugs on the basis of limited data or based on surrogate endpoints merits discussion. In fact, it’s a worry that I have shared. It is important that a drug maker prove the benefits of its drug before unleashing it on the public. However, it also must be acknowledged that at times the FDA is often in a tough place, trying to balance the need for seeing true efficacy for a drug when patients and physicians are demanding access based on limited data. This is particularly true for diseases where there are no other alternatives and where there is a dire need of treatment. Such was the case with Chen’s example of Sarepta’s Duchenne muscular dystrophy drug, Exondys 51, a drug that was approved by Dr. Janet Woodcock (head of the FDA’s Center of Drug Evaluation and Research), over the objections of FDA senior reviewers. But this had little to do with industry financial support of the FDA. The very public nature of this debate teaches more about the challenges in approving new drugs as opposed to being an example of FDA pro-industry bias.
When you ask anyone involved in drug R&D about pro-industry bias on the part of the FDA, they laugh. A company’s FDA interactions with respect to any drug clinical development program are difficult and challenging. That's the way it has always been and that will never change. Furthermore, if you were to ask the CEOs of Pfizer, Merck, Lilly, etc., they would be more than happy to drop the “user fees” and have Congress fully fund the FDA via other funding mechanisms. That would remove any hint of FDA bias. But don’t hold your breath–“user fees” are forever.
I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and
The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects
The agency has withheld critical data on boosters, hospitalizations and, until recently, wastewater analyses.
https://www.nytimes.com/2022/02/20/health/covid-cdc-data.html
Dr. David Kessler, chief science officer of the White House Covid-19 response team, and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, at a House Select Subcommittee in 2021.Credit...Pool photo by Amr Alfiky
Feb. 20, 2022
For more than a year, the Centers for Disease Control and Prevention has collected data on hospitalizations for Covid-19 in the United States and broken it down by age, race and vaccination status. But it has not made most of the information public.
When the C.D.C. published the first significant data on the effectiveness of boosters in adults younger than 65 two weeks ago, it left out the numbers for a huge portion of that population: 18- to 49-year-olds, the group least likely to benefit from extra shots, because the first two doses already left them well-protected.
The agency recently debuted a dashboard of wastewater data on its website that will be updated daily and might provide early signals of an oncoming surge of Covid cases. Some states and localities had been sharing wastewater information with the agency since the start of the pandemic, but it had never before released those findings.
Two full years into the pandemic, the agency leading the country’s response to the public health emergency has published only a tiny fraction of the data it has collected, several people familiar with the data said.
Much of the withheld information could help state and local health officials better target their efforts to bring the virus under control. Detailed, timely data on hospitalizations by age and race would help health officials identify and help the populations at highest risk. Information on hospitalizations and death by age and vaccination status would have helped inform whether healthy adults needed booster shots. And wastewater surveillance across the nation would spot outbreaks and emerging variants early.
Without the booster data for 18- to 49-year-olds, the outside experts whom federal health agencies look to for advice had to rely on numbers from Israel to make their recommendations on the shots.
Kristen Nordlund, a spokeswoman for the C.D.C., said the agency has been slow to release the different streams of data “because basically, at the end of the day, it’s not yet ready for prime time.” She said the agency’s “priority when gathering any data is to ensure that it’s accurate and actionable.”
Another reason is fear that the information might be misinterpreted, Ms. Nordlund said.
Dr. Daniel Jernigan, the agency’s deputy director for public health science and surveillance said the pandemic exposed the fact that data systems at the C.D.C., and at the state levels, are outmoded and not up to handling large volumes of data. C.D.C. scientists are trying to modernize the systems, he said.
“We want better, faster data that can lead to decision making and actions at all levels of public health, that can help us eliminate the lag in data that has held us back,” he added.
divisions that must sign off on important publications, and its officials must alert the Department of Health and Human Services — which oversees the agency — and the White House of their plans. The agency often shares data with states and partners before making data public. Those steps can add delays.
“The C.D.C. is a political organization as much as it is a public health organization,” said Samuel Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation’s Pandemic Prevention Institute. “The steps that it takes to get something like this released are often well outside of the control of many of the scientists that work at the C.D.C.”
The performance of vaccines and boosters, particularly in younger adults, is among the most glaring omissions in data the C.D.C. has made public.
Last year, the agency repeatedly came under fire for not tracking so-called breakthrough infections in vaccinated Americans, and focusing only on individuals who became ill enough to be hospitalized or die. The agency presented that information as risk comparisons with unvaccinated adults, rather than provide timely snapshots of hospitalized patients stratified by age, sex, race and vaccination status.
President Biden joined a virtual meeting with the White House Covid-19 Response Team in December. Credit...Cheriss May for The New York Times
But the C.D.C. has been routinely collecting information since the Covid vaccines were first rolled out last year, according to a federal official familiar with the effort. The agency has been reluctant to make those figures public, the official said, because they might be misinterpreted as the vaccines being ineffective.
Ms. Nordlund confirmed that as one of the reasons. Another reason, she said, is that the data represents only 10 percent of the population of the United States. But the C.D.C. has relied on the same level of sampling to track influenza for years.
Some outside public health experts were stunned to hear that information exists.
“We have been begging for that sort of granularity of data for two years,” said Jessica Malaty Rivera, an epidemiologist and part of the team that ran Covid Tracking Project, an independent effort that compiled data on the pandemic till March 2021.
A detailed analysis, she said, “builds public trust, and it paints a much clearer picture of what’s actually going on.”
Concern about the misinterpretation of hospitalization data broken down by vaccination status is not unique to the C.D.C. On Thursday, public health officials in Scotland said they would stop releasing data on Covid hospitalizations and deaths by vaccination status because of similar fears that the figures would be misrepresented by anti-vaccine groups.
Judge: FDA Cannot Have Until 2076 to Disclose Pfizer/BioNTech Vaccine Data
Published: Jan 07, 2022 By Alex Keown
A U.S. federal judge in Texas has denied attempts by the U.S. Food and Drug Administration (FDA) to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years.
The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit, which was filed in September, the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed.
U.S. District Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT “is of paramount public importance.” The judge’s ruling demands that the FDA make the data publicly available within a span of eight months.
The FDA has not disputed that the data should be made available to the public. However, the regulatory agency has claimed that each page of the file must be closely reviewed in order to redact confidential details or trade secrets that could be exposed.
As BioSpace previously reported, the FDA said there are more than 329,000 pages related to the Pfizer vaccine. The agency said its team is short-staffed. The FDA said it has a 10-person team handling FOIA requests, and there are more than 400 requests that team is addressing. The agency did offer to release 12,000 pages of data and then an additional 500 pages per month on a rolling basis in order to assuage the plaintiffs.
However, in its lawsuit the PHMPT said that would take too long, and again, the judge agreed. In his four-page ruling, Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” Reuters said, but rejected that timetable. Instead of the proposed 500 pages per month that the FDA suggests, the judge ordered the regulatory agency to produce 55,000 pages a month. That puts the release timeline on track by the end of August. Pittman’s ruling does allow for the redaction of information, but only when the agency has “privilege, exemption, or exclusion.” The FDA is expected to submit a rolling status report on the release of the documents by April 1.
Even though the request to release 55,000 pages per month was recognized as burdensome to the FDA, Pittman maintained in his ruling that the release of the documents has to be a high priority for the regulatory agency. Citing the late Sen. John McCain, Pittman noted that the excessive 55-year dissemination plan “feeds conspiracy theories and reduces the public’s confidence in the government.”
The FDA has not indicated whether or not it intends to appeal the ruling.
On its website, PHMPT maintains that it takes “no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses.”
The NBA’s China Problem Keeps Getting Bigger
9 months ago in LifestyleWords By Fabian Gorsler
NBA
The NBA’s close relationship with China has, once again, become a problem. As Reuters reports, a US congressional commission has called for NBA players to end endorsements with Chinese sportswear brands that are believed to be complicit in the forced labor camps in the region of Xinjiang.
The commission warned that any players endorsed by and engaged in a financial relationship with brands such as Li-Ning, Anta, and Peak, could hurt their and the NBA’s images.
“We believe that commercial relationships with companies that source cotton in Xinjiang create reputational risks for NBA players and the NBA itself,” the chairs of the bipartisan congressional-executive commission wrote in a letter to the National Basketball Player’s Association. “The NBA and NBA players should not even implicitly be endorsing such horrific human rights abuses.”
The US government had previously determined that China was committing genocide and crimes against humanity in Xinjiang, barring cotton imports from the region. Since 2018, China is widely believed to have forced minority Muslims to engage in forced labor and “re-education camps,” which, for lack of a better term, are basically concentration camps.
The strongly-worded letter also mentioned that China’s leading sportswear brands Anta, Li-Ning, and Peak had publically embraced Xinjiang cotton, leading the US government to believe that the brands are complicit in the use of forced labor.
https://www.highsnobiety.com/p/nba-china-forced-labor/
U.S. judge tosses $4.5 bln deal shielding Sacklers from opioid lawsuits
December 17, 2021
NEW YORK, Dec 16 (Reuters) - A federal judge overturned a roughly $4.5 billion settlement that legally shielded members of the Sackler family who stand accused of helping fuel the U.S. opioid epidemic, a decision that threatened to upend the bankruptcy reorganization of their company, OxyContin maker Purdue Pharma LP.
U.S. District Judge Colleen McMahon said in a written opinion on Thursday the New York bankruptcy court that approved the settlement did not have authority to grant the Sacklers the legal protection from future opioid litigation that formed the linchpin of Purdue’s reorganization.
Purdue filed for bankruptcy in September 2019 in the face of 3,000 lawsuits accusing the company and Sackler family members of contributing to a public health crisis that has claimed the lives of about 500,000 people since 1999.
2.01M subscribers
From Executive Producer Danny Strong and starring and executive produced by Michael Keaton, “Dopesick” examines how one company triggered the worst drug epidemic in American history. The series takes viewers to the epicenter of America’s struggle with opioid addiction, from the boardrooms of Big Pharma, to a distressed Virginia mining community, to the hallways of the DEA. Watch Dopesick Oct 13, only on Hulu.
Big Tobacco Lawsuit
In 2006, the American Cancer Society and other plaintiffs won a major court case against Big Tobacco. Judge Gladys Kessler found tobacco companies guilty of lying to the American public about the deadly effects of cigarettes and secondhand smoke.
Today, after 11 years of Big Tobacco stalling and negotiating, tobacco companies are being required to run an extensive television and newspaper advertising campaign, at their own expense, admitting the truth about their products.
The court case and this advertising campaign are a major victory for the American Cancer Society, ACS CAN and all Americans.
https://www.fightcancer.org/what-we-do/big-tobacco-lawsuit
AIDS and the AZT Scandal: SPIN’s 1989 Feature, ‘Sins of Omission’
At the end of 1989, two years after we had started the highly controversial AIDS column in SPIN, we published an article by Celia Farber called “Sins of Omission” about the truly bad and corrupt science surrounding promoting AZT as a treatment for the syndrome of diseases.
Celia was the editor and frequent writer of the column and unearthed hard evidence of the cold-bloodedness of the AIDS establishment pushing a drug that was worse than the disease, and killed faster than the natural progression of AIDS left untreated. AZT had been an abandoned cancer drug, discarded because of it’s fatal toxicity, resurrected in the cynical belief that AIDS patients were going to die anyway, so trying it out was sort of like playing with the house’s money. Because the drug didn’t require the usual massively expensive research and trial processes, having gone through that years earlier, it was insanely profitable for its maker, Burroughs Wellcome. It was a tragically perfect storm of windfall profits, something to pacify AIDS activists and the media, and a convenient boom to the patent holders for HIV testing.
https://www.spin.com/2015/10/aids-and-the-azt-scandal-spin-1989-feature-sins-of-omission/
Boeing Settles With Funds That Sued After 737 Max Crashes
Current and former Boeing directors have settled a shareholder lawsuit that accuses the directors of poor oversight before two of the company's jets crashed, killing 346 people.
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Nov. 5, 2021, at 7:23 p.m.
The shareholder lawsuit was filed by administrators of New York state employee retirement funds and a Colorado pension fund for firefighters and police officers. They sued after crashes of Boeing 737 Max jets in 2018 and 2019 killed 346 people.
The lawsuit accused the directors of failing to properly look out for the interests of shareholders in overseeing then-CEO Dennis Muilenburg and development of the Max. Boeing tried to get the lawsuit dismissed, but a judge rejected the move in September.
Insurers for the directors will pay $237.5 million to Boeing, minus fees and expenses, according to documents filed Friday. None of the directors — nor Boeing — will be required to pay anything.
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Thursday, January 7, 2021
Boeing Charged with 737 Max Fraud Conspiracy and Agrees to Pay over $2.5 Billion
The Boeing Company (Boeing) has entered into an agreement with the Department of Justice to resolve a criminal charge related to a conspiracy to defraud the Federal Aviation Administration’s Aircraft Evaluation Group (FAA AEG) in connection with the FAA AEG’s evaluation of Boeing’s 737 MAX airplane.
Boeing, a U.S.-based multinational corporation that designs, manufactures, and sells commercial airplanes to airlines worldwide, entered into a deferred prosecution agreement (DPA) in connection with a criminal information filed today in the Northern District of Texas. The criminal information charges the company with one count of conspiracy to defraud the United States. Under the terms of the DPA, Boeing will pay a total criminal monetary amount of over $2.5 billion, composed of a criminal monetary penalty of $243.6 million, compensation payments to Boeing’s 737 MAX airline customers of $1.77 billion, and the establishment of a $500 million crash-victim beneficiaries fund to compensate the heirs, relatives, and legal beneficiaries of the 346 passengers who died in the Boeing 737 MAX crashes of Lion Air Flight 610 and Ethiopian Airlines Flight 302.
“The tragic crashes of Lion Air Flight 610 and Ethiopian Airlines Flight 302 exposed fraudulent and deceptive conduct by employees of one of the world’s leading commercial airplane manufacturers,” said Acting Assistant Attorney General David P. Burns of the Justice Department’s Criminal Division. “Boeing’s employees chose the path of profit over candor by concealing material information from the FAA concerning the operation of its 737 Max airplane and engaging in an effort to cover up their deception. This resolution holds Boeing accountable for its employees’ criminal misconduct, addresses the financial impact to Boeing’s airline customers, and hopefully provides some measure of compensation to the crash-victims’ families and beneficiaries.”
“The misleading statements, half-truths, and omissions communicated by Boeing employees to the FAA impeded the government’s ability to ensure the safety of the flying public,” said U.S. Attorney Erin Nealy Cox for the Northern District of Texas. “This case sends a clear message: The Department of Justice will hold manufacturers like Boeing accountable for defrauding regulators – especially in industries where the stakes are this high.”
'Downfall: The Case Against Boeing' Doc Director Interview
https://www.hollywoodreporter.com › movie-news › do...
3 days ago — The new Netflix doc explores how the Boeing 737 Max crashes occurred: 'Downfall: The Case Against Boeing' directed by Rory Kennedy.
