AstraZeneca promised to pay medical expenses for anyone injured during its COVID vaccine trials. Now it wants immunity
By Michael Nevradakis, Ph.D. | The Defender | August 22, 2024
AstraZeneca claims it is not obligated to pay medical expenses for a woman injured by its COVID-19 vaccine during a clinical trial because the company is immune from liability under the Public Readiness and Emergency Preparedness Act (PREP Act).
The British-Swedish vaccine maker is asking the court to dismiss a lawsuit filed by Brianne Dressen, who alleges the company reneged on its contract which promised to compensate clinical trial participants for injuries they sustained.
Dressen, founder of React19, a nonprofit advocating for vaccine injury victims, filed a breach of contract lawsuit against AstraZeneca in federal court in May.
According to the lawsuit, AstraZeneca’s consent form for trial participants stated, “If you become ill or are injured while you are in this research study, you must tell your study doctor straight away. The study doctor will provide medical treatment or refer you for treatment.”
Dressen alleged she suffered injuries and disability as a direct result of her November 2020 vaccination, resulting in prohibitive medical costs — with one medication alone costing $432,000 a year. AstraZeneca offered her only $1,243.30 in compensation, prompting her to file the breach of contract claim.
In its motion to dismiss, AstraZeneca claimed it is fully immune from Dressen’s breach of contract claim under the PREP Act of 2005, which provides a liability shield to COVID-19 vaccine manufacturers.
“This action is barred by the PREP Act, which renders AstraZeneca ‘immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure,” the motion states.
According to AstraZeneca’s motion, the company did not waive its PREP Act immunity, but if it did, “any waiver would be strictly confined to ‘the costs of medical treatment for research injuries, provided that the costs are reasonable, and you did not cause the injury yourself.’”
AstraZeneca said Dressen’s claim that the company’s COVID-19 vaccine caused her neurological injuries falls outside the scope of such “research injuries.”
“This is a product liability case alleging personal injuries from the administration of AstraZeneca’s COVID-19 vaccine,” AstraZeneca said, seemingly distinguishing between “research injuries” and “personal injuries.”
AstraZeneca also said Dressen’s lawsuit should not be considered a breach-of-contract claim, but a product liability claim — which would preclude Dressen’s claim “under the Utah Product Liability Act’s two-year statute of limitations.”
Dressen’s opposition to AstraZeneca’s motion to dismiss disputed the product liability claim, stating, “AstraZeneca asks this Court to do what no court has ever done: grant ‘complete immunity’ for contractual violations so long as the violations relate to the administration of covered countermeasures under the PREP Act.”
The document cites precedent exempting breach-of-contract claims from the PREP Act’s immunity provisions. “Each court that has addressed claims of immunity for state contract claims has rightfully held that the PREP Act does not apply.”
Dressen also argued that AstraZeneca waived its immunity “by clearly and unmistakably promising to pay the cost of research injuries.”
In a reply brief filed last week, AstraZeneca repeated its original claims. “Plaintiff’s claims fall squarely within the scope of AstraZeneca’s PREP Act immunity and should be dismissed.”
A hearing on AstraZeneca’s motion to dismiss is scheduled for Oct. 29.
‘PREP Act wasn’t intended to excuse such fraudulent and illicit behavior’
The U.S. never granted emergency use authorization for the AstraZeneca COVID-19 vaccine, citing safety concerns.
In its motion to dismiss though, AstraZeneca claimed, “With the protections of the PREP Act in place, AstraZeneca and its partners successfully developed a lifesaving vaccine in a matter of months, an unprecedented scientific achievement.”
Ray Flores, a health freedom rights attorney unconnected to the lawsuit, told The Defender that the PREP Act’s liability shield for “covered countermeasures” extends to products being tested during clinical trials — but not in cases where there has been a breach of contract.
“A breach of contract such as this should obviously be excluded since the PREP Act is essentially a product liability protection statute,” Flores said.
He added:
“I’d like to think the PREP Act wasn’t intended to excuse such fraudulent and illicit behavior. But so far, under the guise of a pandemic emergency, the courts have determined that anything goes.
“This is the first PREP challenge that alleges a viable breach of contract. Since AstraZeneca’s guarantee was in writing, it has an excellent chance of winning.”
According to Dressen, two days after Dressen signed the consent form, AstraZeneca amended the form to state that its vaccine may cause “neurological disorders” such as “demyelinating disease,” which could “cause substantial disability” or death “if not treated promptly.”
Within hours of getting her first dose, Dressen experienced tingling in her right arm — a neurological condition known as paresthesia — and blurred vision and vomiting.
In the ensuing weeks, her condition worsened, with the paresthesia spreading to her legs, resulting in disability and multiple diagnoses indicating her symptoms were related to her vaccination.
This included a diagnosis in 2021 by the National Institutes of Health (NIH) of post-vaccine neuropathy, which NIH neurologists said caused Dressen’s “dysautonomia” and “chronic inflammatory demyelinating polyneuropathy.”
Dressen, who was 39 when she was vaccinated, was previously a preschool teacher but is now unable to work.
In May, AstraZeneca announced the withdrawal of its COVID-19 vaccine globally — though the company said it based its decision on the “surplus of available updated vaccines,” resulting in reduced demand for its vaccine.
The vaccine generated over $5.8 billion in sales globally, with the help of the Bill & Melinda Gates Foundation, which funded and promoted the vaccine in other countries. Several countries later stopped administering the AstraZeneca vaccine due to safety concerns.
In an ongoing class-action lawsuit in the United Kingdom (U.K.) against AstraZeneca, plaintiffs allege that they were injured — or their family members died — after getting the shot.
In documents AstraZeneca submitted to the U.K. High Court earlier this year, the company admitted that its COVID-19 vaccine “can, in very rare cases, cause TTS” — vaccine-induced thrombosis with thrombocytopenia syndrome, which causes the body to produce life-threatening blood clots.
According to The Telegraph, the U.K.’s Vaccine Damage Payment Scheme has approved 175 applications claiming harm caused by the COVID-19 vaccines, at a set amount of 120,000 pounds (approximately $156,000) per claim, adding that “Around 97 per cent of claims awarded relate to the AstraZeneca jab.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Woman Injured by AstraZeneca COVID Vaccine During Clinical Trial Sues for Breach of Contract
By Michael Nevradakis, Ph.D. | The Defender | May 14, 2024
A woman injured by the AstraZeneca vaccine she received in 2020 during a U.S. clinical trial is suing the vaccine maker in the first case of its kind challenging the legal liability shield for COVID-19 vaccine makers.
Brianne Dressen, who since 2021 has advocated on behalf of vaccine injury victims, filed suit Monday in the U.S. District Court for the District of Utah seeking compensation for injuries and disability she alleges resulted from the vaccine.
Under the Public Readiness and Emergency Preparedness Act (PREP Act), AstraZeneca and other COVID-19 vaccine manufacturers cannot be held liable for injuries related to the vaccines.
However, Dressen’s lawsuit — which also names the Salt Lake City-based clinical trial site consolidator Velocity Clinical Research — contends AstraZeneca can be sued for breach of contract.
According to the lawsuit, the company agreed to cover the medical costs for any vaccine-related injuries under a contract between AstraZeneca and clinical trial participants.
Dressen alleges that in her case, the cost of her injuries and disability amount to hundreds of thousands of dollars per year. Dressen, who was 39 when she was vaccinated, was previously a preschool teacher but is now unable to work.
Within hours of getting her first dose, Dressen experienced tingling in her right arm — a neurological condition known as paresthesia — and blurred vision and vomiting.
In the weeks that followed, her condition worsened, with the paresthesia spreading to her legs, resulting in disability and a diagnosis in 2021 by the National Institutes of Health (NIH) of post-vaccine neuropathy.
The lawsuit seeks “all available damages, both economic and non-economic.”
Attorney Michael Connett of law firm Siri & Glimstad LLP, who is representing Dressen in her lawsuit, told The Defender, “As far as we know, this is the first case in the U.S. where a pharmaceutical company is being held financially responsible for the harms caused by the COVID vaccine.”
Dressen told The Defender that her breach of contract claim “is another first for the United States, as PREP Act protections have been completely impenetrable.”
Dressen, founder of React19, a nonprofit advocating for vaccine injury victims, said she hopes the lawsuit will provide “accountability for my individual case but also bolsters a pathway forward for my injured colleagues both in the U.S. and abroad — namely, each and every plaintiff in the U.K. seeking restitution from AstraZeneca.”
Dressen cited an ongoing class-action lawsuit in the U.K. against AstraZeneca by people alleging they were injured by the AstraZeneca COVID-19 vaccine and by the relatives of 12 people who died after getting the shot.
In documents AstraZeneca submitted to the U.K. High Court last month as part of that case, the company admitted that its COVID-19 vaccine “can, in very rare cases, cause TTS” — vaccine-induced thrombosis with thrombocytopenia syndrome, which causes the body to produce life-threatening blood clots.
Dressen’s lawsuit comes just days after AstraZeneca announced the withdrawal of its COVID-19 vaccine globally — though the company said it based its decision on the “surplus of available updated vaccines,” leading to reduced demand for its vaccine.
The U.S. never granted emergency use authorization for the AstraZeneca COVID-19 vaccine, citing safety concerns.
However, the vaccine generated over $5.8 billion in sales globally, with the help of the Bill & Melinda Gates Foundation, which funded and promoted the vaccine in other countries. Several countries later stopped administering the AstraZeneca vaccine due to safety concerns.
Connett said AstraZeneca’s decision to withdraw the vaccine “really doesn’t have a bearing” on Dressen’s lawsuit.
Ray Flores, a health freedom rights attorney unconnected to the lawsuit, agreed because “the complaint is not based on product liability.”
Flores said:
“Around the country, COVID-19 vaccine injury cases that alleged negligence, battery of a minor, fraud or emotional distress have all been unsuccessful due to the PREP Act — while cases that allege negligence not involving a countermeasure have generally been successful.
What makes this case unique is that it alleges a breach of a written contract. For a court to allow liability protection here would really stretch the extent of the law. But on the other hand, it would unequivocally etch the stench of the PREP Act in Americans’ minds — but my ‘money’ in this case is on the plaintiff.”
AstraZeneca induced people to join trials by promising to pay for injuries
According to Connett, AstraZeneca induced people to join its clinical trial by promising to pay the medical expenses for any injuries that resulted from its COVID-19 vaccine.
“This inducement, this promise, became a contractual obligation the moment study subjects rolled up their sleeve and let the company inject the experimental vaccine into their arm,” he said.
Just because a company is making the COVID-19 vaccine doesn’t give that company a license “to make false promises to induce people to enter its clinical trial,” he said. “The bonanza of immunity that the PREP Act provides does not go so far as to shield a vaccine maker from its own contractual obligations.”
Flores said that if AstraZeneca “never intended to honor its promise to insure Dressen … it would not only be a breach of contract but would rise to the level of fraud.”
“When a vaccine injury lawsuit highlights a defendant’s inhumanity, it is always highly persuasive,” Flores said. “In this case, an absurd $1,243.30 settlement offer after reneging on its written promise to insure when there are evidently millions of dollars in damages and unspeakable suffering is just that.”
Connett said any other individual injured by the AstraZeneca vaccine “has the legal right to recover the full costs of the injury,” but advised that “The time to take legal action, however, may be limited, so acting expeditiously will be important.”
‘Completely hollowed-out version of who I once was’
The lawsuit described the timeline of Dressen’s symptoms following vaccination, with paresthesia spreading to her right shoulder and left arm and later to her legs. Within weeks, she lost 20 pounds as a result of frequent vomiting, while she also developed light sensitivity and became “acutely sensitive to sound.”
Dressen said her heart rate also would randomly spike, leading to shortness of breath and feelings of fainting. She described her experience in the lawsuit as feeling like a “completely hollowed-out version of who I once was.”
Before her Nov. 4, 2020, vaccination, Dressen filled out consent forms stating the company would “cover the costs” — including, but not limited to, medical bills — if she experienced a “research injury.”
Those forms, Dressen said, claimed the study doctor would provide treatment or referral in the event of injury, noting that the study sponsor had the necessary insurance.
“Sponsor will pay the costs of medical treatment for research injuries, provided that the costs are reasonable, and you did not cause the injury yourself,” the contract stated, according to the lawsuit.
The lawsuit notes that two days after Dressen signed the consent form, AstraZeneca amended the form to state that its vaccine may cause “neurological disorders” such as “demyelinating disease,” which could “cause substantial disability” or death “if not treated promptly.”
Dressen received multiple diagnoses indicating her symptoms were related to her vaccination. Her husband eventually reached out to the NIH, which invited her to visit its Bethesda, Maryland, campus “for extensive testing and treatment,” as part of a study the agency was conducting at the time involving people injured by COVID-19 vaccines.
As a result of those tests, NIH neurologists concluded that Dressen had sustained post-vaccine neuropathy, which had caused “dysautonomia” and “chronic inflammatory demyelinating polyneuropathy.”
“The limited safety data that AstraZeneca has released to the public shows that other clinical trial participants who received the company’s COVID vaccine suffered a higher incidence of nervous system disorders, including various types of demyelinating diseases, where the myelin sheaths that protect the nerve cells are stripped away,” Connett said.
AstraZeneca ‘were nowhere to be found’
According to the lawsuit, Dressen’s medical costs are prohibitive. One medication alone costs $432,000 a year, “although her insurance company has been able to negotiate this down (at least for now) to $119,000 per year,” she said.
But despite these high costs and Dressen’s ongoing disability, which makes her “unable to drive more than a few blocks at a time” and limits her parenting ability, the lawsuit states that AstraZeneca offered her only $1,243.30 in total compensation.
“When they needed me, I was there, I cooperated. When I needed them, they were nowhere to be found,” Dressen said in the lawsuit. “I called the test clinic early on with tears running down my face, begging them to help me. They said the drug company would call back any day now. Nightmarish days turned into weeks, and those nightmarish weeks turned into months, and now years. That call never came.”
In July 2021, Dressen’s injuries led her to contact Dr. Anthony Fauci directly to request help, according to documents recently obtained by Children’s Health Defense in a lawsuit against the NIH.
In that email, Dressen said she had been contacting federal health agencies for months with “No substantiative [sic] response.”
Dressen said Fauci never responded to her message.
Calling her lawsuit a “David v. Goliath type case,” Dressen told The Defender her “heart has and always will be with the injured community.” She said, “Every single American injured by a pharmaceutical product deserves their day in court.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
1,295 DEAD in UK Following COVID Bioweapon Shots – Italy Halts AstraZeneca Shots After Teen Dies
By Brian Shilhavy | Health Impact News | June 11, 2021
The UK Government’s reporting system for COVID vaccine adverse reactions from the Medicines and Healthcare products Regulatory Agency released their latest report yesterday, June 10, 2021.
The report covers data collected from December 9, 2020, through June 2, 2021, for the three experimental COVID “vaccines” currently in use in the U.K. from Pfizer, AstraZeneca, and Moderna.
They report a total of 1,295 deaths and 922,596 injuries recorded following the experimental COVID injections.
Here are the breakdowns from the three shots:
- AstraZeneca: 863 deaths and 717,250 injuries. (Source.)
- Pfizer- BioNTech: 406 deaths and 193,768 injuries. (Source.)
- Moderna: 3 deaths and 9243 injuries. (Source.)
- Unspecified COVID-19 injections: 22 deaths and 2335 injuries. (Source.)
Meanwhile, Italy announced today that it was halting use of the AstraZeneca injections for people under the age of 60, following the death of a teenager who died from blood clots.
Danish drug regulator FAINTS at press conference announcing AstraZeneca vaccine halt
RT | April 14, 2021
Denmark will completely abandon the rollout of AstraZeneca’s Covid-19 vaccine due to a risk of rare blood clots. One of the country’s top drug officials passed out at a press conference delivering the news.
As National Health Board Director Soeren Brostroem announced the decision, the Danish Medicines Agency’s acting director of pharmacovigilance, Tanja Erichsen, fainted and collapsed to the ground.
Erichsen’s fall sparked panic, as Brostroem and other officials rushed over to check on her. The medicines agency later announced that she had regained consciousness, but was taken to hospital for a checkup. No explanation was given for her fainting.
Denmark was the first country in the world to suspend the rollout of AstraZeneca’s Vaxzevria shot in March, though a number of other countries followed suit, among them France, Germany, Italy and Spain. Denmark, however, is the first country in the world to permanently ditch the British-Swedish developed jab.
“In the midst of an epidemic, it has been a difficult decision to continue our vaccination program without an effective and readily available vaccine against Covid-19,” Brostroem said at the press conference. “However, we have other vaccines at our disposal, and the epidemic is currently under control.”
The suspension is expected to push the country’s vaccination timeline back by “some weeks,” according to a report from Danish broadcaster TV2.
Denmark began vaccinations in December, and has to date approved four vaccines – from AstraZeneca, Johnson & Johnson, Moderna and Pfizer/BioNTech. Only two shots, from Moderna and Pfizer, are currently available to Danes, after Johnson & Johnson delayed its own European rollout on Tuesday, due to several cases of blood clots being reported in the US.
AstraZeneca Recruiting 5 Year-Old Kids For Covid Vaccine Trial
By Richie Allen | February 14, 2021
AstraZeneca is planning a childhood immunisation programme that it says, could protect people from Covid-19 for most of their lives. Yesterday the company announced it was recruiting kids as young as five for the trials. Children participating in the trial will get their first jab by the end of this month. Pfizer is planning a similar trial on a global scale.
AstraZeneca believes that by giving children a “series of jabs” in early life, they’d be giving them a lifetime of immunity from Covid. Professor Sarah Gilbert, an Oxford scientist who worked on the AstraZeneca vaccine said:
“If they get infected it will just be a mild disease, it won’t be very serious, it will just be a sniffle. We’re all really waiting to see how things play out. We could be looking at giving young children immunity, and then boosting it towards the end of life.”
Children are basically immune from coronavirus. Most of them will never get it and those who do will have mild symptoms only. Kids DO NOT need a coronavirus vaccine. What’s going on? A Five-year old should not be compelled to participate in a vaccine trial. The child cannot give informed consent. Any parent who puts their child forward for the trial is guilty of neglect and I’d go further than that. It’s child abuse.
They’re already giving as many as 16 vaccines to children in this country, most of them totally unnecessary. Now they want to vaccinate them just in case they get Covid as an adult? It’s insane. Is there any opposition to this anywhere? The answer is no. The papers and the broadcasters just repeat this crap. None of them has the balls to challenge it. I despair.
Richie Allen is the host of The Richie Allen Radio show, Europe’s most listened to independent radio show and is a passionate supporter of free speech. He lives in Salford with the future Mrs Allen and their two dogs.
UK Intelligence to Fight Anti-Vaccine Propaganda Spread by State Actors, British Media Reports

Anti-vaccine demonstrators in Edinburgh © Sputnik / Jason Dunn
By Tim Korso – Sputnik – 09.11.2020
A UK intelligence unit, known as the Government Communications Headquarters (GCHQ), has been authorised to conduct cyber operations to tackle the spread of anti-vaccine propaganda online, The Times reported citing an anonymous government source. According to the newspaper, the government increasingly views anti-vaxxers as a new priority because of the upcoming registration of domestically-developed vaccines against the coronavirus.
Apart from GCHQ, a secretive UK Army unit within the 77th Brigade specialising in information warfare will be taking part in the efforts “to quash rumours about misinformation” related to the COVID-19 vaccines, General Sir Nick Carter confirmed to The Times.
The newspaper’s source claims that GCHQ will be using the same toolkit it utilised to combat Daesh and its propaganda and recruitment efforts. The toolkit includes ways of taking down undesired content and conducting cyber attacks against the cyberactors behind it, for example by encrypting the perpetrators’ computer data, The Times added.
“GCHQ has been told to take out anti-vaxxers online and on social media. There are ways they have used to monitor and disrupt terrorist propaganda”, the anonymous source claimed.
However, GCHQ will not be able to use its tools against everyone online because its authority only extends to dealing with [alleged] state cyber actors and the content created by them, the newspaper reported citing another anonymous government source.
Russia as Main target for UK Intelligence Cyber Operations?
The British newspaper claims Russia will be the GCHQ’s prime target, citing its own investigation into the country’s alleged ties to the surge of internet memes questioning the safety of the vaccine developed by Oxford University in concert with AstraZeneca. The said investigation was based on a trove of documents and images provided by an anonymous source, who claimed to be part of an alleged propaganda effort purportedly seeking to hurt the image of the British vaccine. The Times, however, admitted in its article that it could not directly link the alleged social media campaign, targeting only the UK vaccine, with the Kremlin.
According to the newspaper, the alleged campaign against the AstraZeneca/Oxford vaccine started after the head of the Russian Direct Investment Fund (RDIF) that developed Sputnik V, Kirill Dmitriev, called the UK-developed medicine a “monkey vaccine” on several occasions. Dmitriev referred to the vaccine’s usage of a monkey virus as a vector to deliver the COVID-19 material needed to form immunity. He did not directly call the drug dangerous or ineffective, but noted that the use of human adenoviruses was more reliable, as their influence on the human body is better understood.
Dmitriev’s use of the term “monkey vaccine” prompted the emergence of numerous internet memes, baselessly alleging that the British drug would be turning recipients into monkey-like creatures or otherwise negatively affecting patients’ health. The head of RDIF later denounced the use of his words to besmirch the UK-developed vaccine, but defended his concerns over the possibility of its long-term side effects.
COVID-19: RDIF Points to Absence of Long-Term Studies on Vaccines Based on Monkey Adenoviral Vectors
By Aleksandra Serebriakova – Sputnik – 09.09.2020
The third round of trials for the AstraZeneca anti-COVID-19 drug is now on pause over “potentially unexplained illness” in a participant in the UK. On 11 August, Russia registered its own Sputnik V anti-coronavirus vaccine, which is said to have been developed in a different way.
The Russian Direct Investment Fund (RDIF) the investor which has funded the development of Russia’s Sputnik V anti-coronavirus vaccine, could not comment on the halt of AstraZeneca trials, it said in a statement.
However, RDIF pointed out that the fund’s CEO Kirill Dmitriev had previously discussed the differences between the human adenoviral vector-based platform used in Russia’s Sputnik V vaccine and those used by some of their international colleagues, that rely on “novel unproven technologies such as monkey adenoviral vectors or mRNA”.
“The safety of the human adenoviral vector used in Sputnik V has been proven over decades in over 250 clinical studies, as human adenovirus has been shown to be the safest vaccine delivery mechanism and the most ‘organic for humans’, as human adenovirus has coexisted with humans for over 100,000 years,” RFID said.
Meanwhile, “mRNA and monkey adenoviral vector-based platforms have not been studied over a long period of time,” RDIF CEO Dmitriev pointed out this Tuesday.
Commenting on the so-called “pledge of safety” earlier voiced by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi in relation to the development of the first COVID-19 vaccines, Dmitriev stressed that this plea was “insufficient” as it did not “discuss the lack of long-term studies on the carcinogenic effects and impact on fertility of newly-developed vaccine technologies”.
“Since some of the companies developing these vaccines have taken the ‘pledge of safety’, we would like to stress that public health and safety requires not only short-term evidence of a lack of serious adverse effects, but also the safety and efficacy proved by the results of long-term studies,” Dmitriev added.
AstraZeneca COVID-19 Vaccine Trials on Pause
It was revealed this week that the third round of trials for the AstraZeneca anti-COVID-19 vaccine has been halted due to a “potentially unexplained illness” which had developed in a participant in the United Kingdom, without further specifications about the nature of possible side effects. The vaccine in question was developed in partnership with Oxford University and has reportedly involved around 30,000 participants in the UK, US, Brazil and South Africa. AstraZeneca described the pause as “routine” so as to allow for a “standard review process” of “safety data”.
Russia’s First Anti-Coronavirus Vaccine
On 11 August, Russia registered the world’s first vaccine against COVID-19, called Sputnik V, which was developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the RDIF after several rounds of clinical trials. On Monday, the vaccine was made available to the public.
According to RDIF, Russia has now received requests for 1 billion doses of the vaccine; at least 20 countries, including the UAE, Saudi Arabia, Indonesia, Philippines, Mexico, Brazil and India, have expressed an interest in obtaining Sputnik V.
The Withering of Big Pharma?
By Martha Rosenberg | Dissident Voice | November 7, 2013
It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.
On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory. J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.
At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.
But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra, Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.
Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.
Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.
Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine. If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.
The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.
Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.
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Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.
