[HN Gopher] Pfizer Penalties Since 2000: $10B
___________________________________________________________________
Pfizer Penalties Since 2000: $10B
Author : bigtex
Score : 275 points
Date : 2022-12-21 13:41 UTC (9 hours ago)
(HTM) web link (violationtracker.goodjobsfirst.org)
(TXT) w3m dump (violationtracker.goodjobsfirst.org)
| kodyo wrote:
| wutheringh wrote:
| salawat wrote:
| Lets see some individual links shall we?
|
| Fen-Phen: caused cardiovascular/lung dmg. 3.75B
|
| https://violationtracker.goodjobsfirst.org/violation-tracker...
|
| Civil and criminal penalties: 2.3B
|
| >American pharmaceutical giant Pfizer Inc. and its subsidiary
| Pharmacia & Upjohn Company Inc. agreed to pay $2.3 billion to
| resolve criminal and civil liability arising from the illegal
| promotion of certain pharmaceutical products. Pfizer was required
| to pay a criminal fine of $1.195 billion and Pharmacia & Upjohn
| was required to forfeit $105 million, for a total criminal
| resolution of $1.3 billion. The other $1 billion represented a
| civil False Claims Act penalty.
|
| https://violationtracker.goodjobsfirst.org/violation-tracker...
|
| Rezulin liver damage. 750 mm
|
| >In January 2004 Pfizer announced that it had taken a $975
| million charge to cover legal costs, including 35,000 personal
| injury lawsuits alleging that the diabetes drug Rezulin, which
| had been sold by its subsidiary Warner-Lambert, caused liver
| damage. The company did not announce the cost of the Rezulin
| settements, but it was reported that the amount was $750 million:
|
| Celebrex/Bextra 745 mm
|
| >Primary Offense: drug or medical equipment safety violation
| Secondary Offense: product safety violation Violation
| Description: In October 2008 Pfizer said it was taking a charge
| of $894 million to cover litigation costs relating to its anti-
| inflammatory drugs Bextra and Celebrex. Of the total, $745
| million was to cover product liability suits relating to the two
| drugs.
|
| Chantix: suicidal/depressive behavior 288m
|
| https://violationtracker.goodjobsfirst.org/violation-tracker...
|
| Honestly, without even looking at PACER, the fact I'm seeing
| these plus consumer protection + workplace safety + kickbacks and
| bribes has me seriously wondering why we don't crack down harder
| on companies that see the occasional criminal/civil case/willful
| non-compliance charge as the cost of doing business.
|
| I'm almost afraid to look through the legal briefs, because I'm
| sure either A) it'll destroy what little faith I've managed to
| hold onto in humanity, or B)it'll just make my drive to go to law
| school to become a civic pain in the ass that much worse.
| coldtea wrote:
| AKA "cost of doing business"
| willcipriano wrote:
| colpabar wrote:
| All the experts are baffled!
| ranting-moth wrote:
| I couldn't see any summary for total prison time for individuals.
| Does anyone know if that's because there hasn't been a any or is
| is just missing?
|
| I somehow feel with a $10B (which include bribes/kickbacks) there
| ought to have been some.
| gorbachev wrote:
| For the High Score search for financial offenses:
|
| https://violationtracker.goodjobsfirst.org/summary?offense_g...
|
| Bank of America in a league of its own.
| Jensson wrote:
| The interesting thing is that every big bank is doing these
| offenses. There is nowhere to go if you want a well behaved
| bank, so regulation is the only way to get there.
| weberer wrote:
| I don't see my credit union on that list. Or any credit
| union, for that matter.
| Semaphor wrote:
| I wonder if there's an international list somewhere. As a
| German, I find it unacceptable that your country name bank is
| supposedly more criminal than ours.
| mrep wrote:
| Haha, Deutsche bank is in there [0]! Rookie numbers though,
| only 18 billion in fines.
|
| [0]: https://violationtracker.goodjobsfirst.org/parent/deutsc
| he-b...
| Semaphor wrote:
| That's what I'm saying. These are only US fines, they
| surely did some crimes elsewhere without bribing the right
| people or hiding it.
| TrickyRick wrote:
| To the surprise of absolutely nobody, the whole list is banks.
| Wronnay wrote:
| The list is about financial-related offences - so there are
| only financial companies on the list.
|
| E.g. here is a list about environment-related offences: https
| ://violationtracker.goodjobsfirst.org/offense_group/env...
| dncornholio wrote:
| Without context, it can either be 'Pfizer is bad' or 'laws are
| too strict'. I can't make an educated guess.
| monsecchris wrote:
| Pretty good rundown of one of the largest pharma fines:
| https://www.reuters.com/investigates/special-report/johnsona...
|
| For extra bonus points I think they did miss the part where J&J
| specifically targeted minorities in their advertising for these
| products that they knew caused cancer.
| johndhi wrote:
| I actually used to work for them as a lawyer, indirectly. My view
| is likely a bit skewed in the other direction, but to me this is
| mostly evidence of how expensive and impossible it is to do
| business in healthcare in the United States.
|
| How are the laws and regs so unclear that a huge corporation of
| smart people can't avoid big fines? Part of it is a question of
| Pfizer's investment in compliance - which I assure you is massive
| - but also it's a lack of clarity and shifting goal posts.
|
| False claims act litigation, for example, is responsible for the
| second largest settlement listed on this site (phen fen is #1), a
| notorious and utterly incomprehensible regime where all of the
| big money settlements relate to aggressive fringe theories
| asserted by DOJ.
| dec0dedab0de wrote:
| _How are the laws and regs so unclear that a huge corporation
| of smart people can 't avoid big fines?_
|
| Without having any knowledge of said people and laws, I would
| say that some of those smart people are making decisions to
| help their personal bottom line while putting the company at
| risk. Anyone working at a large company sees this all the time.
| JacobThreeThree wrote:
| Pfizer gets plenty of fines outside the United States too.
| qwerty456127 wrote:
| > How are the laws and regs so unclear that a huge corporation
| of smart people can't avoid big fines
|
| Perhaps they don't really care to? Apparently paying penalties
| is just a part of the business model, net profits/savings made
| thanks to the violations still exceeding net fines.
|
| I'm not sure about Pfizer but I feel almost sure this is the
| way Google and other big tech corporations providing "free"
| services work paying huge fines for privacy violations every
| now and then. Google will still spies on you and records
| everything it can about you no matter how much do you tweak
| your settings and how hard does the EU try to protect your
| privacy rights, doesn't it?
| shadowgovt wrote:
| I can't speak to medical specifically, but in one of the
| spaces I used to work the thinking was "The law is ambiguous
| because it's reactive; we're so far out on the bleeding edge
| that nobody _actually knows_ what 's legal until someone
| tries it and someone else makes a case of it. So pushing the
| envelope is a net positive for society because we end up
| blazing a trail of bright-line precedent rulings that other
| companies can follow. You can tell the pioneers because
| they're the ones with the arrows in their backs."
|
| A bit self-serving but there's some meat on the bones of that
| logic; the real meaning of the law _is_ path-dependent and
| determined by the rulings, not the words on the paper.
| thatguy0900 wrote:
| In fairness there's Noone you can call up in the government
| to ask for certain if something is legal or not past a
| certain point. Only a judge can decide that, and they don't
| do hypothetical cases.
| forgetfreeman wrote:
| It's also worth noting that the parent claim of unclear
| compliance guidelines is less of a statement of fact and more
| a commentary on your average pharma industry lawyer. There
| are more suites of standardized compliance applications than
| you could shake a stick at, that's not at issue. The problems
| usually start with a department of contract lawyers who can't
| be assed to skill up on industry specifics. Throw in a CFO
| with little or no experience managing CRO's and you've got
| the perfect recipe to get dumped on by the OIG.
| mulletbum wrote:
| I didn't go through all of the False Claims litigation, but the
| penalties were related to pricing, nothing to do with their
| science.
| avgDev wrote:
| Pfizer product issues:
|
| _During the mid-1980s, watchdog organizations such as the
| Public Citizen Health Research Group charged that Pfizer's
| widely prescribed arthritis drug Feldene created a high risk of
| gastrointestinal bleeding among the elderly, but the federal
| government, despite reports of scores of fatalities, declined
| to put restrictions on the medication. A June 1986 article in
| The Progressive about Feldene was headlined DEATH BY
| PRESCRIPTION.
|
| The Food and Drug Administration expressed greater concern
| about reports of dozens of fatalities linked to heart valves
| made by Pfizer's Shiley division. In 1986, as the death toll
| reached 125, Pfizer ended production of all models of the
| valves. Yet by that point they were implanted in tens of
| thousands of people, who worried that the devices could
| fracture and fail at any moment.
|
| In 1991 an FDA task force charged that Shiley had withheld
| information about safety problems from regulators in order to
| get initial approval for its valves and that the company
| continued to keep the FDA in the dark. A November 7, 1991
| investigation in the Wall Street Journal asserted that Shiley
| had been deliberately falsifying manufacturing records relating
| to valve fractures.
|
| Faced with this growing scandal, Pfizer announced that it would
| spend up to $205 million to settle the tens of thousands of
| valve lawsuits that had been filed against it. Even so, Pfizer
| resisted complying with an FDA order that it notify patients of
| new findings that there was a greater risk of fatal fractures
| in those who had the valve installed before the age of 50. In
| 1994 the company agreed to pay $10.75 million to settle Justice
| Department charges that it lied to regulators in seeking
| approval for the valves; it also agreed to pay $9 million to
| monitor valve patients at Veterans Administration hospitals or
| pay for removal of the device.
|
| In 2004 Pfizer announced that it had reached a $60 million
| settlement of a class-action suit brought by users of Rezulin,
| a diabetes medication developed by Warner-Lambert, which had
| withdrawn it from the market shortly before the company was
| acquired by Pfizer in 2000. The withdrawal came after scores of
| patients died from acute liver failure said to be caused by the
| drug.
|
| In 2004, in the wake of revelations about dangerous side
| effects of Merck's painkiller Vioxx, Pfizer agreed to suspend
| television advertising for a related medication called
| Celebrex. The following year, Pfizer admitted that a 1999
| clinical trial found that elderly patients taking Celebrex had
| a greatly elevated risk of heart problems.
|
| In 2005 Pfizer withdrew another painkiller, Bextra, from the
| market after the FDA mandated a "black box" warning about the
| cardiovascular and gastrointestinal risks of the medication. In
| 2008 Pfizer announced that it was setting aside $894 million to
| settle the lawsuits that had been filed in connection with
| Bextra and Celebrex._
| simonebrunozzi wrote:
| > How are the laws and regs so unclear that a huge corporation
| of smart people can't avoid big fines?
|
| Unless these big fines are because such corporation has been
| really, really bad...
| kilroy123 wrote:
| I work in health care for a health care start. Literally my co-
| workers and I were just talking about this. How it's all such a
| racket and way too expensive and complicated.
|
| How do we get out of this hole? How do we fix health care and
| fix these issues?
| busyant wrote:
| > I actually used to work for them as a lawyer, indirectly.
|
| I was a small-time expert witness (on the plaintiff's side)
| against them in a very small lawsuit. It was the first and last
| time I served in that capacity.
|
| A child was born with horrific birth defects. Parents claimed
| that a specific medication caused it. Pfizer obviously said
| otherwise.
|
| The whole thing left me feeling dirty. Experts charging $600 /
| hour (this was over a decade ago, so God knows what they charge
| now) to say, with diamond-hard confidence, whatever their side
| wanted them to say.
|
| Plaintiff's experts: "That drug _definitely_ caused the birth
| defects."
|
| Defense experts: "There is no possible way that drug could
| cause birth defects."
|
| Basically, here was a tragedy, and we all feasted on it. One of
| the other experts told me I could be "good at this" (selling
| myself out as an expert), but it just left me feeling dirty.
| rnikander wrote:
| A woman once told me that she made $300K/year as an "expert
| witness", on various topics. She was smart and she said she
| would study a bit and go testify. It blew my mind. I didn't
| understand whether she was working for the mafia, or if this
| was legal, or what. I said something like, "but, wait, you're
| not an expert. The court allows this?" She didn't understand
| my problem. She seemed entitled; despite her IQ she may not
| have understood what an actual expert was. I never got to the
| bottom of it and lost track of her.
| busyant wrote:
| > she may not have understood what an actual expert was.
|
| There is a legal "standard" around the admissibility of
| expert testimony
| (https://en.wikipedia.org/wiki/Daubert_standard).
|
| The person who got me to testify told me he made around
| $700 K per year. He drove a ~$200K Maybach so I had no
| reason to doubt him.
|
| I also met a plaintiff's lawyer who told me, roughly, "If
| the lawsuit ever sees a jury, the jury _never_ understands
| the science. It 's all about likeability and looking good.
| I had a juror tell me, 'I picked your side because you had
| a really nice tie.' So, I always wear a nice tie!"
|
| That was probably a hyperbolic story, but I'm sure there's
| a lot of truth to it, too.
| vorpalhex wrote:
| The court does not want a deep guru on every topic. It
| effectively wants a bridge between a specialized domain and
| the court itself (which is made of lay people.)
|
| I would expect an Expert to study on the particulars of a
| case. In general as long as they are sufficiently narrow I
| don't see a problem here.
| mschuster91 wrote:
| I'd rather expect someone as a court-appointed expert
| that they have relevant, certified experience. In
| Germany, while judges are legally free to appoint whoever
| they want as experts unless there exist specially
| certified experts for the class of assessment[1], the
| parties involved usually present actual experts to the
| judge for selection - and the opposing side would
| challenge the selection of non-qualified experts.
|
| [1] https://www.gesetze-im-internet.de/stpo/__73.html
| kwere wrote:
| a reason for having specialized courts in specific
| domains of law instead of laymans in the 18th century
| enlightenment inspired (outdated) system we have. Also
| checks and balances on judges, one of the most
| unaccountable caste there is
| irrational wrote:
| If someone says they are an expert at nuclear
| engineering, I expect they can build a working reactor in
| their basement, not that they have read a pamphlet and
| might know the difference between fission and fusion.
| vorpalhex wrote:
| Your critera excludes most of the NRC.
|
| The court does not need to build a nuclear reactor. They
| need someone who can help the court understand nuclear.
|
| Your theoretical person may be a bad choice if they have
| no communication skills.
| johndhi wrote:
| Yeah. This, and also the original post (the entire legal
| system) is based on this adversary system of incentives to
| demand you did nothing wrong and fight your opponent. It
| makes it hard to tell what's true.
| sporkland wrote:
| Here are John Carmack and Tim Sweeney's takes on expert
| witnesses: https://mobile.twitter.com/id_aa_carmack/status/82
| 7187311452...
| throwayyy479087 wrote:
| What was the outcome? I hope the parents won
| busyant wrote:
| > What was the outcome?
|
| My understanding is that it was messy. The parents/kid got
| some money. Maybe $1 - 1.5 million?? But my memory is hazy
| on that. Obviously, their parents' lawyer took some
| percentage of that.
|
| I'm pretty sure the (parents') lawyer who hired me took on
| _other_ plaintiff 's lawyers as "investors" (I forget the
| proper term for what he did). Basically, he didn't have
| enough money to pay for everything up front [like expert
| witnesses], so he sold fractional "ownership" in his future
| earnings on the case in exchange for funds. This was a part
| of the business that I did not know existed prior to my
| testimony.
|
| My suspicion is that he took away very little after the
| rest of us got paid (family, support staff, "investors",
| etc.).
|
| My deposition was probably pretty typical, but it was
| shocking to me.
|
| - The defense lawyers flew out to _me_ and rented a
| conference room at a local law office.
|
| - At around 9AM, the main defense lawyer sat across a table
| from me and pulled out stack after stack of documents and I
| thought, _" Wow, she brought a lot of extra reading for
| herself. I should be done here by around 11 and I can go
| home and mow the lawn."_
|
| - NOPE! Every stack of documents was there to rebut some
| specific sentence that I wrote in my initial report.
|
| - There were a lot of insults and efforts to get under my
| skin. For example, after I used some technical term, she
| said, _" That's a big word. Do you really know what it
| means?"_
|
| - The only reason the deposition stopped was because she
| had to catch a flight back to the west coast around 5 PM.
|
| - The kicker was that "MY" lawyer asked if I'd be willing
| to give them BOTH (plaintiff AND defense) a ride to the
| airport (defense lawyer said she'd pay me my rate for the
| ride).
|
| - I told them I had to get home, but really I took the
| whole thing too personally because I thought, _" You just
| insulted me for six-and-a-half hours? Now you want me to
| drive you to the airport? I'll pass."_
|
| - And then the lawyers took a taxi together like they were
| old friends.
|
| Obviously, it's just business for them, but I'm not built
| for that.
| williamscales wrote:
| > How are the laws and regs so unclear that a huge corporation
| of smart people can't avoid big fines?
|
| They aren't. What is clear is that a huge corporation of smart
| people simply don't care about fines.
|
| The answer is to make the fines much bigger, big enough that a
| single one would threaten the existence of Pfizer.
| johndhi wrote:
| Based on what research is this a good idea?
|
| The US system is unique and we're entrenched. This is too big
| a change.
| mym1990 wrote:
| This is silly, there should be a middle ground. A 1 strike
| policy would just stifle any innovation coming out of a
| company.
| williamscales wrote:
| Yeah, I wouldn't advocate a 1 strike policy. Fines should
| escalate with repeated violations.
|
| The fines should be tied to revenue and after some
| violations they should reach the point where the business
| cannot continue.
| krisoft wrote:
| > False claims act litigation, for example, is responsible for
| the second largest settlement listed on this site (phen fen is
| #1), a notorious and utterly incomprehensible regime where all
| of the big money settlements relate to aggressive fringe
| theories asserted by DOJ.
|
| Well. I looked the case up.
|
| Here is how i am understanding it: Pfizer wanted a drug to be
| approved for a specific use. The FDA rejected it as too risky,
| approved it for other uses. Pfizer nevertheless was pushing the
| drug for this unaproved, off-label use. The drug later proved
| to be dangerous in this off-label use and were whitdrawn from
| the market.
|
| Am I reading this wrong? What part of this is controversial?
|
| If you ask for permission for something, then been told no you
| do it anyway and in that process people suffer harm what should
| happen then?
| johndhi wrote:
| Off label litigation is a great example of my point.
| Extremely muddy waters.
|
| Physicians constantly ask pharma about and explore off label
| drug prescriptions. This is legal: psychiatrist can tell you
| to take a drug approved for nerve pain for depression. There
| is research showing it works for depression but it has not
| technically been added to the label of the drug yet following
| fda approval. Pharma can provide the studies and answer
| limited questions on the topic (but no clear guidance) but
| cannot "promote" this. Is presenting the research promotion?
| Is the rep discussing it with the doctor promotion? Etc
| esel2k wrote:
| Just to add how difficult these off-label uses are beeing
| managed. Every content we provide (be it in a discussion,
| or a comment in one if our forums or as part of a symposia)
| needs to be checked for offlabel use. This is a nightmare
| and every single screen of my apps or of the content that
| is uploaded needs to be reviewed by medical
| teams/compliance. Its a nightmare.
|
| Now tell me what is "was promoted by pfizer"? A doctor
| saying it in a comment/presentation that he tried this with
| on patient and storing this on one of our digital
| platforms? It's really grey water...
|
| And add to this hard times for medical reps after covid.
| forgetfreeman wrote:
| Pffffft. Explain why Pfizer keeps making epic regulatory
| faceplants when much smaller organizations, ostensibly with
| less industry experience, routinely manage to navigate
| regulations in the US without issue?
| unmole wrote:
| A behemoth like Pfizer is a more attractive target for
| enforcement agencies?
| spamizbad wrote:
| Pfizer has more "surface area" but beyond that, no.
| Prosecutors love shooting fish in a barrel: it actually
| makes smaller biotech firms more attractive regulation
| targets.
| johndhi wrote:
| Disagree. Every civil prosecutor I've ever worked with
| wants a big "story." They are driven by headlines. Taking
| down local mom's pharmaco is the opposite of the
| narrative people want to read in the paper.
|
| We like the headline of this article: megacorp pfizer is
| evil. That's why we're in this thread, right?
| forgetfreeman wrote:
| You may disagree but the history of the Office of
| Inspector General crapping on sub-200 headcount biotech
| and pharma startups doesn't mesh with any of that. Keep
| in mind smaller firms don't put up anywhere near the
| fight a multinational like Pfizer is capable of, and the
| OIG knows this.
| willcipriano wrote:
| We are told the opposite fairy tale when it comes to the
| IRS.
|
| "They have to go after regular people and small business
| owners because corporations have too many lawyers!"
| Kranar wrote:
| When you control for population, high income individuals
| are more likely to be audited than the middle class:
|
| https://www.irs.gov/about-irs/irs-audit-rates-
| significantly-...
|
| There is no article about it, but the same also holds for
| businesses. There are just soooo many more small to
| middle sized businesses compared to large corporations.
| fallingknife wrote:
| That's what I'm told, but not by the IRS. It is a fairy
| tale, though. Small businesses cheat on their taxes in
| incredibly stupid and simple ways. e.g. running personal
| expenses through the business is absolutely rampant. I
| even know a guy who got a tax deduction buying a $60K
| engagement ring this way. This stuff is extremely easy to
| catch in an audit, and requires very little resources
| from the IRS. These business owners will always settle
| quickly and never fight, because they are guilty as hell
| and it's easy to prove.
|
| At big corps, on the other hand, this type of activity is
| heavily policed and almost impossible. The idea that
| large corporations are rampant tax cheats is completely
| false. The reason that they would never dare is because
| the IRS has a whistleblower program where you get to keep
| a percentage of the proceeds, which at a big corp will be
| multiple millions of dollars. So any intentional tax
| cheating will be reported and caught immediately by
| employees who stand to gain more than their salary for
| their whole career.
|
| The worst that a big corp will ever do is dip a toe into
| the legal gray areas of tax law. And in that case the IRS
| will be hesitant to go after them because it takes a ton
| of resources, and they stand a very high chance of
| losing. Not because the big corp has too many lawyers,
| but because the opposition has a legit case, unlike the
| small business owner who bought his engagement ring on
| the company card. The idea that anyone has too many
| lawyers for the government to handle is ridiculous
| anyway.
|
| So it makes complete sense for the IRS to target small
| businesses and regular people and not big corps. But
| people don't like this because it goes against the "big
| corp bad, small business good" religious belief.
| mschuster91 wrote:
| > The idea that large corporations are rampant tax cheats
| is completely false.
|
| And yet, large corporations, especially banks, are
| _continuously_ caught with blatant abuse of the tax code
| (e.g. the "cum ex" scandal in Germany, where banks
| outright looted the government) or their customers.
|
| The problem is that the fines are way too low. What does
| a large corporation care about a fine of even a billion
| dollars? Spread out over the time of the violation,
| that's petty cash, and as long as the execs don't have to
| go to jail, D&O insurance will pay any personal
| punishments.
| fallingknife wrote:
| Cum ex was a loophole. Which is exactly my point. Large
| corps don't just openly break the law, they exploit
| loopholes and gray areas.
| antihero wrote:
| Also offshore accounting.
| clucas wrote:
| Interesting, who makes that argument?
| willcipriano wrote:
| I can find someone making that case with a quick Google:
| https://www.april15th.com/irs-problems/why-irs-audits-
| more-s...
|
| > The IRS brings in more dollars per hour auditing small
| mom and pop businesses, than they do auditing medium and
| large companies.
|
| > Why is that the case? Because the larger companies keep
| impeccable records and have tax experts to defend them;
| Enrolled Agents, CPAs, or tax attorneys that usually know
| more about the Tax Code than the IRS auditor-employee.
|
| I've found it in my conversations with people justifying
| the recent increases in IRS agents and the new $600
| reporting requirement.
| clucas wrote:
| Reading that link, it appears they are saying the IRS is
| concentrates its efforts on small businesses because they
| have the best chance of recovery.
|
| You called it a fairy tale, do you believe that big
| corporations are actually bigger tax cheats than small
| businesses, and they're just getting away with it
| somehow?
| willcipriano wrote:
| I do not have any of direct evidence of anything, I'm
| just a guy with a brain. This is one of many in a long
| series of "coincidences" that when put together starts to
| become nonsensical.
|
| Look at where we started.
|
| Pfizer gets fined more beacuse they are a bigger company
| and have more surface area, the law is complex and
| everyone is breaking it all the time so action against
| them doesn't mean they did anything wrong. In and of
| itself fine, that may be true.
|
| Then those same people will later say, the IRS went after
| that Mexican restaurant instead of Pfizer beacuse they
| are so big, and run such a tight ship that it would
| almost impossible to find any wrong doing.
|
| The tax code is very complex, so is drug regulation. Is
| the idea that Pfizer is hyper competent in tax law but
| incompetent when it comes to the core business? That
| doesn't hold water for me.
| clucas wrote:
| Maybe you're right, but I think it's more likely that
| Pfizer, as a business, is more willing to accept risk in
| the pursuit of its core business aims than in its
| accounting, and that's all we're seeing.
| https://slatestarcodex.com/2019/01/14/too-many-people-
| dare-c...
| s1artibartfast wrote:
| It could also be that the endeavor of drug discovery and
| manufacture is inherently more risky than accounting.
| From the academic sense, it is not a field of
| mathematical certainty, but one of subjective risk-
| benefit tradeoffs.
| transcriptase wrote:
| In Canada it's a common argument as to why the CRA goes
| after waitresses for unclaimed tips and similar trivial
| cases, versus tackling high-net worth and corporate tax
| evasion/fraud. It comes down to dollars recovered per
| agent hour as a metric for the government. The average
| joe can't afford to tie up the CRA in court for years
| with high-paid legal teams, which means that their KPI
| results are negatively correlated with the financial
| resources of their target. Why spend years _potentially_
| recovering millions when you can spend minutes recovering
| hundreds or thousands with virtually no risk?
| forgetfreeman wrote:
| Nah. Regulators have performance metrics same as everyone.
| They'll gleefully target 150 headcount biotech firms in a
| heartbeat if they think there's a win to be had and smaller
| firms generally dont have the legal war chest required to
| fight a complianceviolation beef. See Also: OIG going after
| United Therapeutics on light pretext.
| jollyllama wrote:
| I'll join the sibling comments in speculation: They're so big
| that they can either get away with it in aggregate or when
| they can't, can count on favorable judgements, like the
| comment about J&J. Favorable in the sense that the
| individuals personally responsible won't face the
| ramifications.
| forgetfreeman wrote:
| Nailed it in one. I'm old enough to vividly remember the
| first time Pfizer the corporations-are-people business
| entity was convicted of a felony. In the decades since not
| only have they failed to substantially alter their approach
| to compliance issues, most of the largest industry players
| have followed suit since the profit/loss ratio for ignoring
| regulations has been shown by Pfizer's financials.
| RcouF1uZ4gsC wrote:
| Because Pfizer is a bigger target?
|
| Kind of like 3 Felonies a Day, lots of times the
| laws/regulations are so labyrinthine that if they look at you
| closely, they will find something.
| hoffs wrote:
| Because you make example of big player, not small one.
| themaninthedark wrote:
| But the opposite is claimed with respect to IRS audits.
| With that we are told the IRS goes after and fines the
| little guy because the rich can spend money for defense.
|
| Shouldn't we expect to see similar behaviors across
| regulators?
| wbl wrote:
| There are very different incentives for different
| regulators who operate with different bodies of law and
| degrees of compliance.
| [deleted]
| mulletbum wrote:
| Can someone point me to one of the 90 incidents that is "Gave
| false study data."
|
| I went through 10 of them and they are all "Advertising where
| they shouldn't be" or "incorrectly stating costs."
|
| Comments in here are like a conservative sess pool and it is 3
| comments in. It is like no one read any of the data. Who would
| have thought?
| 40amxn40 wrote:
| No, it's the opposite. The vast majority of studies have
| dubious methodologies or samples, draw dubious conclusions or
| extrapoltions using dubious models. Hence the replication
| crisis.
|
| It's perfectly fine to be skeptical, moreso when colossal
| monetary incentives are in place.
|
| But, unlike what the HN guidelines say, I think you already
| know this and that your comment is in bad faith.
| mdorazio wrote:
| Then it should be trivial for you to do exactly what the
| parent comment asked for and provide an example rather than
| calling it a bad faith argument.
| mulletbum wrote:
| Kind of think your comment is in bad faith....
| rand0mx1 wrote:
| There are many users on HN with anti-science bias, data means
| nothing to them
| coldtea wrote:
| Yeah, and most of them root for Pfizer because "private for
| profit company == science"...
| stonogo wrote:
| I run in some fairly lefty circles and I can safely state
| I've never heard of anyone (of ANY political leaning) "root
| for Pfizer" edit: except their actual paid PR people.
| mbg721 wrote:
| And anybody who holds significant shares of their stock.
| stonogo wrote:
| No, the folks I know are more likely to sell stock they
| don't like than cheer for it against their own
| principles. That's assuming they buy individual stocks,
| which most people don't.
| mbg721 wrote:
| Those people don't hold an amount that's significant,
| though.
| dilap wrote:
| I don't know if anything ever came of it, but a whistleblower
| in their covid vaccine trial alleged data issues and ignoring
| negative side effects:
|
| > A regional director who was employed at the research
| organisation Ventavia Research Group has told The BMJ that the
| company falsified data, unblinded patients, employed
| inadequately trained vaccinators, and was slow to follow up on
| adverse events reported in Pfizer's pivotal phase III trial.
| Staff who conducted quality control checks were overwhelmed by
| the volume of problems they were finding. After repeatedly
| notifying Ventavia of these problems, the regional director,
| Brook Jackson (video 1), emailed a complaint to the US Food and
| Drug Administration (FDA). Ventavia fired her later the same
| day
|
| https://www.bmj.com/content/375/bmj.n2635
|
| Even things like "Advertising where they shouldn't be" are not
| neccessarily innocuous; e.g. it can be promoting use of a drug
| in a situation that is known to be unsafe. In lawsuits
| regarding Bextra (which Pfizer ended up settling for around
| 1b),
|
| > the state alleged that despite the significant safety
| concerns that led FDA to reject a request to market high dose
| Bextra for acute and surgical pain, Pfizer conducted a
| systematic, multi-pronged "off-label" promotional campaign for
| these very indications.
| mlcrypto wrote:
| Funny how fast these drug companies gained the undying trust of
| every liberal overnight. Almost like it was orchestrated
| woodruffw wrote:
| Pfizer does not have my "undying trust," nor are they required
| to for me to get a vaccine. I've been getting vaccines under
| the same regulatory framework for my entire life, and all (to a
| first approximation) were made by companies that I despise.
| ausbah wrote:
| what was orchestrated exactly? I am not a fan of big corps in
| general, but if they're offering an effective solution to
| sudden global crisis I will give credit where credit is due.
| llanowarelves wrote:
| After Occupy Wallstreet, big banks and companies realized they
| could redirect the heat ("eat the rich", mock guillotines etc.)
| they were taking from the left elsewhere by taking up such
| vocabulary, heaping praise on feminism, LGBT, POC, etc. and
| other corporate social justice. It seems to have worked.
|
| How can someone be bad if they are speaking nicely about,
| advertising, and helping these groups? They can't.
|
| And most recently, SBF (someone with experience doing it)
| confirmed this with his DMs about how you're expected to say
| these things to stay on good terms.
|
| And this is not even getting into the revolving door between
| industry and regulation, which may be the real story, but the
| above providing social cover, backed by media as PR.
| someNameIG wrote:
| I'm a biologist, I don't trust the companies, I trust the
| published research and global regulatory bodies. And given the
| reason Pfizer has been discussed by the general public in the
| last few years, I'll remind everyone Moderna also exists :)
| Mistletoe wrote:
| Yes and 19.8 million people are still alive because of it in
| the first year.
|
| https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
|
| For comparison, World War I was 40 million casualties.
| t0bia_s wrote:
| Story is not finished. Thousands, maybe even milions are
| already dead because of them, millions have serious damage
| health because of them. Trials are not finished yet so we
| don't even know what will happen in long term. Also... Excess
| mortality in various countries is above average.
|
| Neil M., Fenton N.E.: Latest statistics on England mortality
| data suggest systematic mis-categorisation of vaccine status
| and uncertain effectiveness of Covid-19 vaccination, December
| 2021, preprint https://www.researchgate.net/publication/35675
| 6711_Latest_st...
|
| Beattie K.A.: Worldwide Bayesian Causal Impact Analysis of
| Vaccine Administration on Deaths and Cases Associated with
| Covid-19: A Big Data Analysis of 145 Countries, 15 Nov 2021
| https://vector-
| news.github.io/editorials/CausalAnalysisRepor...
|
| Britt TJ. et al: Group Life Covid-19 Mortality Survey Report,
| August 2022 https://www.soa.org/4a368a/globalassets/assets/fi
| les/resourc...
|
| Kuhbandner Ch., Reitzner M.: Excess mortality in Germany
| 2020-2022, August 2022, preprint
| https://www.eugyppius.com/p/exhaustive-study-of-german-
| morta...
|
| Morz M.: A Case Reporti: MUltifocal Necrotizing Encephalitis
| and Myocarditis after BNT162b2 mRNA Vaccination against
| COVID-19, Vaccines 2022, 10(10), 1651, Oct 01, 2022
| https://www.mdpi.com/2076-393X/10/10/1651
|
| https://ec.europa.eu/eurostat/web/products-eurostat-
| news/-/d...
|
| https://ec.europa.eu/eurostat/databrowser/view/demo_mexrt/de.
| ..
|
| https://www.skirsch.com/covid/GermanAnalysis.pdf
|
| https://www.researchgate.net/publication/355581860_COVID_vac.
| ..
| ausbah wrote:
| I don't have the domain expertise nor the time to address
| everything you've posted - and maybe these aren't valid
| reasons to distrust what you've shared - but I'm skeptical
| of your conclusion bc many are unreviewed studies from over
| a year ago by authors who don't have relevant background,
| and few are straight up right wing rags full of conspiracy
| theories & other nonsense.
| z3c0 wrote:
| Since COVID, I've noticed a "quantity over quality"
| strategy deployed en masse by the pseudo-intellectual
| right. It allows one to give the impression of a well-
| researched response without doing any of the needed work.
|
| It's almost as if they realize that posting a wall of
| links will daunt most into not questioning them, even if
| most of the links wouldn't survive a hint of scrutiny.
| t0bia_s wrote:
| I also noticed, that people who dont have arguments or
| refuse to read, likes to post off topic.
| z3c0 wrote:
| You might need a preening; your feathers are looking
| rustled.
| t0bia_s wrote:
| So why bother to judge something that you refuse to read?
| Are you serious?
|
| Graphs from EU data about excess mortality are conspiracy
| theories now?
| nerdponx wrote:
| > So why bother to judge something that you refuse to
| read?
|
| They _did_ read it, and concluded it wasn 't useful.
|
| > Graphs from EU data about excess mortality are
| conspiracy theories now?
|
| Excess mortality, by design, does not say anything about
| causes. In the USA for example, you can hypothesize a
| variety of plausible reasons for continued high excess
| mortality, pandemic-related and otherwise (increased
| crime, lower incomes, decreased access to non-Covid
| healthcare, increased highway speeds, et alia), but the
| excess mortality number itself cannot tell you the
| relative strengths of those causes.
| t0bia_s wrote:
| "They did read it, and concluded it wasn't useful."
|
| Response was few minutes after post. No wonder that
| answer is not even related to content of links.
| ausbah wrote:
| I never mentioned the dashboards, I'm on mobile so they
| weren't loading for me. Also yes, I think I can give a
| pretty good judgement on the quality of a piece based on
| simple heuristics like the quality of the hosting site,
| or the background credentials of the authors.
| t0bia_s wrote:
| Be more specific. What background of which author? What
| quality of hosting site?
| mikeyouse wrote:
| Posting charts reflecting excess mortality during a
| pandemic and attributing that to the vaccine gives the
| game away a bit, no?
| PuppyTailWags wrote:
| tbh, I didn't see any establishment of causal
| relationship with excess mortality. This is like
| debugging a program by looking at the git history,
| without actually seriously thinking about what the bug
| actually is. It could be something recent. It could be
| something that was messed up ages ago and is only coming
| to rear its head now.
| nerdponx wrote:
| You should see the trash that gets posted in anti-vaccine
| groups. There are whole nutritional and supplement
| protocols meant to counteract "vaccine damage", and these
| pseudo-science studies get paraded around like religious
| texts.
| pfisherman wrote:
| Sorry but we have more hard data on the COVID vaccine(s)
| than pretty much any drug in recorded history.
|
| With things like electronic health records, insurance
| claims databases, and state vaccine registries; it is
| trivial to check whether or not someone who is admitted to
| a hospital for COVID hot a vaccine or not.
|
| Arguing that the COVID vaccines we have available in the US
| are not effective is like arguing that the average global
| temperature has not increased over the last 50 years, or
| that smoking does not increase the risk of lung cancer and
| emphysema. You are making extraordinary claims that
| contradict a mountain of data.
| t0bia_s wrote:
| Yet, you are not link any data.
| [deleted]
| analog31 wrote:
| Interesting website. For reference, I checked Ford Motor Company,
| and they're at roughly 1/2 billion. Microsoft 1/3 billion.
|
| My start-up isn't on the list. I paid a $15 penalty for late
| filing of state sales tax one year. ;-)
| mkoryak wrote:
| Maybe we can increase your fines: Please tell us of any laws
| your startup have broken
| pcrh wrote:
| Frankly, this is an illustration why punitive action against
| senior executives is the best way to prevent corporate
| malfeasance.
| 93po wrote:
| I think the best way is to treat corporations like people -
| they go to prison. Shut down operations for however many years
| and disallow them from making transactions of any sort during
| their sentence. Going after executives is just going to lead to
| scapegoats.
| swader999 wrote:
| Safe and effective!
| TheMagicHorsey wrote:
| Anyone that has worked in any highly regulated industry knows
| that its almost impossible to comply with every rule. Even the
| regulators themselves, (and the ex-regulators that you hire to
| run your compliance team) often have absolutely no idea how to
| get anything done AND comply with all the regs.
|
| As an example, its simply impossible to build a factory on a
| greenfield site in California today and comply with all the regs.
| Its just insane.
|
| Or try to set up a drone testing field anywhere in California.
| hansel_der wrote:
| > Anyone that has worked in any highly regulated industry knows
| that its almost impossible to comply with every rule.
|
| true
|
| otoh there is something like "compliance with the spirit of the
| regulation" that is morally acceptable but will be exploited
| unless fiercely and proactively defended.
| ibejoeb wrote:
| It's certainly true that some regs exist solely as alternative
| tax regimes, but Pfizer is chock full of really bad stuff.
|
| There are numerous instances of falsified study data and many
| instances of injury.
|
| We can't have it both ways. Since we're going down the
| compulsory dosing route, and we can bypass the necessarily
| arduous approval process for drugs, someone's gotta pay up when
| there's a mess.
|
| This is the same thing that caused the Boeing fiasco. "It's
| really hard to certify an airframe" turned into "in this case
| it's nbd," and that turned into a bunch of planes crashing.
| yashap wrote:
| I think the largest fine here, the $3.75 billion fine for the
| American Home Products diet drug in 2002
| (https://violationtracker.goodjobsfirst.org/violation-
| tracker...), is mis-attributed to Pfizer. American Home Products
| became Wyeth Pharmaceuticals, who were acquired by Pfizer in
| 2009, 7 years after this fine.
|
| Pfizer weren't involved with them in 2002, so I don't see how
| this five can be reasonably attributed to Pfizer.
| menage wrote:
| I think that depends a bit on how many of the folks tainted by
| the AHP violation are still working at Pfizer. If Pfizer is
| made up of a bunch of companies that had violations themselves
| before acquisition, that's probably reflected in the current
| company culture.
| klabb3 wrote:
| Not to mention that acquiring a company that's been massively
| fined for these reasons is a statement in itself. (Statement
| being somewhere between "we don't give a shit" and "good job,
| even we didn't think of that")
| [deleted]
| mchusma wrote:
| Looking at the top settlements here I think as a society we would
| be better off without these able to be this big. Generally
| speaking they all seem to relate to off-label use (which I think
| we should generally be more permissive of) and false claims. But
| looking through one case, https://www.seegerweiss.com/drug-
| injury/rezulin-lawsuit/ it seems that liver damage was a known
| side effect. I don't see any real indication that this was
| hidden, it was a part of the FDA filing. It seemed like a "net
| positive", and then later it was decided "no, probably not".
|
| The issues here seem more related to binary FDA categories. It
| basically either: 1) Banned 2) Approved and must be covered by
| insurance
|
| When there really can and should be more categories of risk,
| like: 1) Banned because we know this is super bad 2) Not banned,
| but not recommended 3) Not banned, seems ok but there are bad
| side effects or other concerns that warrant attention 4) Not
| banned, seems good, lots of good data and this should definitely
| be covered
|
| This would allow companies to put drugs in the market to help
| people, but set realistic expectations. There is no fraud if the
| data is there and the categories are clear.
| sschueller wrote:
| Credit Suisse paid over 11 Billion in fines in the last 10 years.
| [1]
|
| [1] https://www.srf.ch/news/wirtschaft/credit-suisse-unter-
| druck...
| forgetfreeman wrote:
| We're talking about Pfizer.
| walterbell wrote:
| J&J has $15B in penalties, but has an innovative legal strategy,
| https://www.esquire.com/news-politics/politics/a41191693/joh... &
| https://www.newyorker.com/magazine/2022/09/19/johnson-johnso...
|
| _> Deploying a legal maneuver first used by Koch Industries,
| Johnson & Johnson, a company valued at nearly half a trillion
| dollars, with a credit rating higher than that of the United
| States government, declared bankruptcy. Because of that move, the
| fate of forty thousand current lawsuits and the possibility of
| future claims by cancer victims or their survivors now rests with
| a single bankruptcy judge in the company's home state, New
| Jersey._
| lotsofpulp wrote:
| https://www.investopedia.com/texas-two-step-bankruptcy-defin...
|
| Why would a non corrupt judge allow this "transfer of
| liabilities"?
|
| > In June 2021, one such lawsuit resulted in an appeals court
| in Missouri ordering the company to pay $2.1 billion to the
| claimants. Later that year, the company used a divisive merger
| to create a new subsidiary called LTL Management LLC,
| transferring its talcum-related liabilities to that subsidiary
| along with a $2 billion trust intended to provide funding for
| any potential future claims against LTL.
| ClarityJones wrote:
| The maneuver can be pierced if the plaintiffs prove that the
| subsidiary was undercapitalized.
|
| So, a non-corrupt judge may allow this if the maneuver is
| genuinely done for accounting / management / etc. reasons and
| the new subsidiary has sufficient capital to cover the
| liabilities.
|
| A non-corrupt judge may also "allow" it if the plaintiffs
| never attempt to pierce the veil in the first place. Like a
| lizard casting off its tail, this may be enough to appease
| the lawyers representing the class. With the issue never
| getting to the judge, the judge never has enough information
| to disallow it.
| shkkmo wrote:
| > the maneuver is genuinely done for accounting /
| management / etc. reasons
|
| What sort of reasons could those be? I don't see any reason
| for those types of maneuvers besides trying to sidestep
| some amount of liability.
| ClarityJones wrote:
| If we frame it as a maneuver that's associated with /
| driven by a major liability, then that sort of begs the
| question.
|
| However, generally, companies may spin brands off for
| reasons such as:
| https://www.finra.org/investors/insights/splitting-
| differenc...
|
| Are these reasons sometimes convenient covers for what is
| really an attempt to avoid liability? Of course, and
| probably fairly often.
| DSingularity wrote:
| Because justice is blind. Don't you love the platitudes that
| only seem to benefit the establishment?
| funstuff007 wrote:
| another win for the ratings agencies...
| varispeed wrote:
| Penalties or costs of doing business?
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