Pharmaceutical Corruption Media ArticlesExcerpts of Key Pharmaceutical Corruption Media Articles in Major Media
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Big Pharma spent more than any other industry to lobby Congress and federal agencies this year, a Reuters analysis shows, but is still on course for a major defeat by failing to stop a bill that allows the government to negotiate prices on select drugs. The $430 billion Inflation Reduction Act to change climate, health, and tax policies cleared its largest hurdle last week when Democratic lawmakers passed it in the Senate. The U.S. House of Representatives is also expected to pass it on Friday, allowing President Joe Biden to sign it into law. A Kaiser Family Foundation poll in October found that 83% of Americans, including 95% of Democrats and 71% of Republicans, want the federal Medicare health plan for seniors to negotiate prices. The industry's powerful trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), urged senators in a public letter to reject the bill. A Reuters analysis ... shows that the pharmaceutical industry has spent at least $142.6 million on lobbying Congress and federal agencies in the first half of 2022, more than any industry, and at least $16.1 million on campaign contributions during the current mid-term election cycle. Almost two thirds of the money spent on lobbying ... came from PhRMA and its member companies. The bill's provision for drug price negotiations was scaled back in November, allowing Medicare to focus on an annual maximum of 20 of the costliest medicines by 2029, instead of an initial proposal to help reduce prices for 250 treatments.
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It's estimated that more than 107,000 people in the United States died due to opioid overdoses in 2021. Washington Post journalist Scott Higham notes it's "the equivalent of a 737 Boeing crashing and burning and killing everybody on board every single day." In the new book, American Cartel, Higham and co-author Sari Horwitz make the case that the pharmaceutical industry operated like a drug cartel, with manufacturers at the top; wholesalers in the middle; and pharmacies at the level of "street dealers." The companies collaborated with each other – and with lawyers and lobbyists – to create legislation that protected their industry, even as they competed for market share. "It really is the companies that run the show," Higham says. "People were dying by the thousands while these companies were lobbying members of Congress ... to pass legislation and to lobby members of the Department of Justice and try to slow down the DEA enforcement efforts." Big pharma fought to create legislation that would limit the DEA's ability to go after drug wholesalers. The efforts were effective; more than 100 billion pills were manufactured, distributed and dispensed between 2006 and 2014. Meanwhile, both federal and state DEA agents are frustrated by the ways in which their enforcement efforts have been curtailed. Right now there are 40,000 Americans who are in jail on marijuana charges. And not one executive of a Fortune 500 company involved in the opioid trade has been charged with a crime.
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A group of whistleblowers has provided evidence that the Environmental Protection Agency has not adequately assessed the health risks posed by several new chemicals on the grounds that they are corrosive. Those harms include cancer, miscarriage, and neurotoxicity, according to the whistleblowers, who work as health assessors in the division. In some cases â₏¦ the risks were calculated, found to be significant, and later deleted from official documents. In March 2020, Gallagher, the human health assessor, found that another chemical presented risks to workers. Information [about the hazards] was included in a version of the assessment. But a month later, a manager in the New Chemicals Division created a new assessment [that] explained: "Risks were not evaluated for workers via repeated dermal exposures because dermal exposures are not considered likely due to the corrosivity of the new chemical substance." According to the whistleblowers, this statement is false. "It is intentionally misleading for EPA to put into a report that we did not calculate risk when we did," said Martin Phillips, a chemist and human health assessor who works in the EPA's Office of Pollution Prevention and Toxics. "It's lying about what we did. It's not just that we did the calculations. We did the calculations and found risks, and then they got rid of them and said that we didn't calculate them. It's fundamentally inaccurate."
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We urgently need a national debate about guns. But we also urgently need a national debate about the epidemic of mood-altering drugs being prescribed to young Americans. Mass shooters in the United States tend to be young, obsessive, male loners and many have been prescribed psychoactive drugs. For example, Eric Harris, one of the two shooters at Columbine High School in Columbine, Colorado, in 1999–which ushered in the current spate of mass shootings–was on the psychotropic drug Luvox. Prescribing information for the antidepressant says, "Close supervision of patients and in particular those at high risk should accompany drug therapy." Jeff Weise, who fatally shot his grandfather, his grandfather's girlfriend, and then seven others at the Red Lake Senior High School in Minnesota in 2005, was on the well-known antidepressant Prozac. Two years later, Cho Seung-Hui, who perpetrated the Virginia Tech mass shooting, also was found to be on psychoactive antidepressants. Jeanne Stolzer, associate professor of child and adolescent development at the University of Nebraska-Kearney, observes that "despite the multitude of international drug regulatory warnings on all classifications of psychiatric medications citing adverse reactions such as suicidal ideation, homicidal ideation, violence, and psychosis, not one local, state, or federal commission has investigated the correlation between the mass shootings in America and the use of psychiatric medications."
Note: Although Epoch Times is often deemed as a controversial media platform, this article raises legitimate questions on an important topic seldom discussed. Read a revealing article that investigates the alarming adverse events associated with common mood-altering medications prescribed for those struggling with mental illness. For more on this concerning trend, consider exploring an in-depth article written by an anonymous doctor who reveals the decades of evidence showing how adverse reactions from psychiatric drugs can manifest as both suicides and homicides.
Today it's my great pleasure to introduce two Pulitzer Prize-winning Washington Post journalists, Sari Horwitz and Scott Higham, who are going to discuss their new book, "American Cartel." We're talking about companies that create and fuel the opioid crisis. We've heard this story about the Sacklers and indeed the Sacklers have been identified, and if criminal charges haven't been brought at least they've been vilified in the press. But ... this goes way beyond the Sacklers. This is not just the story of one bad apple. "It's so much bigger than that," [said Horwitz]. "We found, in our two-year investigation ... a constellation of companies that fuel the deadliest epidemic, drug epidemic, in American history. Some of these companies are some of the largest in this country. Some we've heard of. They are household names - Walgreens, Walmart, Johnson & Johnson. We found internal emails from these companies where the people in the companies were laughing at the addicts. They were mocking them. Meanwhile, the drug companies, they are smart. They decide to lure away the best and the brightest if they can from the DEA and the Justice Department to help them as they are selling opioids, and they are very successful. They hired dozens of people from DEA and the Justice Department to work for these companies. So again, these are the people who are trying to protect us, working for the DEA and the Justice Department. They are lured away to the companies who are selling addictive painkillers that are killing people."
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California will begin making its own low-cost insulin in an effort to make the essential diabetes treatment more affordable, Gov. Gavin Newsom announced on Thursday. "Nothing epitomizes market failures more than the cost of insulin," the governor said in a video posted on Twitter, "Many Americans experience out-of-pocket costs anywhere from three hundred to five hundred dollars per month for this life-saving drug." With a budget of $100 million, California plans to "contract and make our own insulin at a cheaper price, close to at cost, and to make it available to all," Newsom said. It's unclear exactly how inexpensive California's insulin will be or when the low-cost drugs will be available. Insulin in the U.S. costs almost $100 per unit, on average. That's nearly four times the price in Chile, which has the second-highest prices among the 34 countries analyzed by the nonprofit Rand Corporation, at less than $25 per unit. Currently, four in five Americans in need of insulin have incurred thousands of dollars in credit card debt to pay for the medication, according to a recent survey commissioned by health care organization CharityRx. The average debt among all survey participants was $9,000. California's program will allot $50 million toward the development of cheaper insulin products and $50 million on an in-state insulin manufacturing facility, Newsom said, adding that the facility "will provide new, high-paying jobs and a stronger supply chain for the drugs."
Note: The unethical corruption of big Pharma is so clearly seen in the ridiculously inflated prices of drugs in the US compared to other countries. For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma profiteering from reliable major media sources.
Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate. In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through "user fees." The FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold–from around $29m in 1993 to $884m in 2016. In Europe, industry fees funded 20% of ... the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is 89%. Australia had the highest proportion of budget from industry fees (96%) and in 2020-2021 approved more than nine of every 10 drug company applications. But for decades academics have raised questions about the influence funding has on regulatory decisions, especially in the wake of a string of drug and device scandals–including opioids, Alzheimer's drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, and pacemakers. An analysis of three decades of PDUFA in the US has shown how a reliance on industry fees is contributing to a decline in evidentiary standards, ultimately harming patients. A BMJ investigation last year found several expert advisers for covid-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers–ties the regulators judged as acceptable.
Note: For more on this massive legal corruption, see this article. For more along these lines, see concise summaries of deeply revealing news articles on corruption in government and in Big Pharma from reliable major media sources.
Medicare's drug program could have saved up to $3.6 billion in 2020 by mirroring the pricing strategy of entrepreneur and Shark Tank judge Mark Cuban's online pharmacy, according to a new study. Cuban's Cost Plus Drug Co. offers a selection of generic drugs at the cost of manufacturing them plus a flat 15% markup. The direct-to-consumer pharmacy does not accept insurance. The study's authors suggest that Medicare is overpaying for many generic drugs and could save billions a year if it purchased them directly from Cuban's online pharmacy. "The lower prices from a direct-to-consumer model highlight inefficiencies in the existing generic pharmaceutical distribution and reimbursement system, which includes wholesalers, pharmacy benefit managers, pharmacies, and insurers," wrote researchers at Brigham and Women's Hospital and Harvard Medical School in a brief published ... in the journal Annals of Internal Medicine. Cuban and his pharmacy did not fund or have any involvement in the study. Cost Plus Drug Co. says it engages in price negotiations with drugmakers. Medicare's drug program, Part D, however, prohibits the government from directly negotiating pharmaceutical prices. Researchers compared 2020 Medicare spending for a total of 89 drugs ... to their prices at Cost Plus Drug Co. in February. They estimate that Medicare overpaid for 77 generic drugs, spending $8.1 billion compared with $4.5 billion if the federal agency had purchased at the same prices as Cost Plus Drug Co. charges.
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Public health initiatives in the United States are suffering from a crisis of trust. Recent polls show that only a third of the public trusts insurance and pharmaceutical companies, while just 56 percent trust the government health agencies that are meant to regulate these industries. Another survey during the COVID-19 pandemic showed that only around half of Americans have a "great deal" of trust in the CDC, while a mere third have such trust in the Department of Health and Human Services. When the mRNA vaccines for COVID-19 were made available to the public free of charge, a national conversation began about "vaccine hesitancy"–the phenomenon of Americans choosing not to be vaccinated even when incentivized and, in some cases, coerced. Americans had watched public health experts lie, misdirect, ignore evidence and yield to professional pressure. Few wanted to be their guinea pigs. Not all the COVID-19 gaslighting was the fault of the media or politicians - much was implemented by experts abusing their apolitical position of trust. The experts ... including Drs. Deborah Birx and Anthony Fauci, insisted on the most asinine and evidence-free preventative measures, including facial coverings, lockdowns and social distancing. Their insulated role as health advisers enabled them to manipulate health policy in ways that benefited only themselves. The most stark example was the corruption of data collection at the Center for Disease Control–a scandal that crashed public trust to a new low.
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Celebrity investor Mark Cuban is receiving praise on social media after he launched a new company that provides patients access to affordable medications. Cuban launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a direct-to-consumer online company that offers more than 100 generic medications at discounted prices. The investor said ​​he aims to "be the low-cost provider of medications to patients." He continued: "If you don't have insurance or have a high deductible plan, you know that even the most basic medications can cost a fortune. Many people are spending crazy amounts of money each month just to stay healthy. No American should have to suffer or worse–because they can't afford basic prescription medications." The company's low costs are achieved by working directly with partners, which "allows us to only markup our costs by 15 percent," Cuban explained. Explaining the business model, Cuban cited the drug prescribed for hookworm, Albendazole, which can cost as much as $500 per course. "Our cost for Albendazole is $26.08 per course. We mark that price up by 15 percent so we can continue to run the company and invest in disrupting the pricing of as many drugs as we possibly can," he explained. "That makes the base price of the drug $30. Then we add on the actual cost, $3.00, that our pharmacy partners charge us to prepare and provide your prescription to you. "That makes the sales price on this website $33. Far, far lower than the pricing available in the marketplace."
Note: As big Pharma rakes in the huge profits, Marc Cuban has created a new company called CostPlus which brings many expensive drugs to you at a fraction of the price. Sadly, very few of the major media are reporting on this. Cuban says, "Everyone should have safe, affordable medicines with transparent prices."
The prices of new drugs in the U.S. have climbed for more than a decade, a study published Tuesday finds. According to a research letter in the Journal of the American Medical Association, the launch prices of new brand-name drugs increased by nearly 11 percent every year from 2008 through 2021. "These prices are increasing far out of proportion to other health care services," said the lead author, Dr. Benjamin Rome. Rome, and his colleagues observed price increases for all types of drugs, including cancer drugs, non-cancer drugs, pills and injections, he said. "Ultimately," he said, "all health care costs are borne by consumers – either direct out-of-pocket costs, higher premiums or taxes in the case of public health insurance." He added, "Insurance companies can also require prior authorization for expensive new drugs or not cover the drugs at all." The researchers calculated the negotiable sticker prices for new drugs on the market, or the net price. Such prices, which were adjusted for inflation, were calculated in light of rebates many drugmakers offer for the drugs. The researchers limited their scope to drugs sold by public companies; the net price averages included nearly 400 new drugs in total. Median drug prices for a year's supply increased from $2,115 in 2008 to more than $180,000 in 2021. The greatest increases were for cancer drugs and therapies used to treat rare diseases. In 2008, 9 percent of drugs cost $150,000 or more a year, compared to 47 percent in 2021.
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American hospitals have been living with serious drug shortages for more than a decade. Most days, nearly 300 essential drugs can be in short supply. It's not a matter of supply and demand. The drugs are needed and the ingredients are easy to make. Pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit. Yet, year after year, the government stays on the sidelines as companies take drug production offline - and doctors worry the shortages are compromising patient care. Neonatologist Dr. Mitch Goldstein treats the most vulnerable patients. Many ... premature and sick babies have undeveloped digestive systems, so Dr. Goldstein keeps them alive with intravenous nutrients, many of which are in short supply. Antony Gobin heads the pharmacy at Loma Linda Hospital. He told us shortages of basic drugs are a constant worry. "We were dealing with shortages long before COVID," [he said]. "They're all very old, fundamental drugs that every hospital in the country needs and uses." Drug shortages can kill. In 2011, when norepinephrine, an old, low profit drug used to treat septic shock, was in short supply, hundreds of people around the country died. Middlemen, the group purchasing organizations and drug distributors take their cut. The drug manufacturers end up with just a small fraction of what the patient pays. Many have simply stopped making the least profitable drugs.
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Why have so many smart, well-trained doctors stood by as American healthcare descended into a state of profound dysfunction? The answer lies in the gradual, nearly invisible commercial takeover of the medical "knowledge" that doctors are trained to trust. In 1981, President Ronald Reagan slashed government support of university-based medical research. Following the 1980 passage of the University and Small Business Patent Procedures Act, nonprofit institutions and their researchers were allowed to benefit financially from the discoveries made while conducting federally funded research. Over the past few decades, the drug companies have taken over most of our clinical research. In 1991, academic medical centers (AMCs)–hospitals that train doctors and conduct medical research–received 80 percent of the money that industry was spending to fund clinical trials. But by 2004, the percentage of commercially funded clinical trials conducted by AMCs had fallen from 80 to just 26 percent. That ... allowed the commercial funder to own, and thus control, the data from jointly conducted research. Unbeknownst to almost all doctors, peer reviewers are not granted access to the underlying data that serves as the basis for the reported findings. The drug companies own that data and keep it confidential. Reviewers must rely on brief data summaries. Peer reviewers at even the most prestigious medical journals cannot possibly attest to the accuracy and completeness of the articles they review.
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Jeff Smith, a partner with the influential consulting firm McKinsey & Company, accepted a highly sensitive assignment in December 2017. The opioid manufacturer Purdue Pharma ... sought out Dr. Smith. His team reviewed business plans and evaluated new drugs that Purdue hoped would help move the company beyond the turmoil associated with OxyContin, its addictive painkiller that medical experts say helped to spark the opioid epidemic. But the corporate reorganization was not Dr. Smith's only assignment. He was also helping the Food and Drug Administration overhaul its office that approves new drugs – the same office that would determine the regulatory fate of Purdue's new line of proposed products. A review ... of internal McKinsey documents found that the firm repeatedly allowed employees who served pharmaceutical companies, including opioid makers, to also consult for the F.D.A., the drug industry's primary government regulator. And, the documents show, McKinsey touted that inside access in pitches to private clients. In an email in 2014 to Purdue's chief executive, a McKinsey consultant highlighted the firm's work for the F.D.A. and stressed "who we know and what we know." McKinsey also allowed employees advising Purdue to help shape materials that were intended for government officials and agencies, including a memo in 2018 prepared for Alex M. Azar II. References to the severity of the opioid crisis in a draft version of the memo ... were cut before it was sent to Mr. Azar.
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On September 19, 2019, House Speaker Nancy Pelosi introduced the Elijah Cummings Lower Drug Costs Now Act. The bill ... would allow the federal government to negotiate drug prices on behalf of Medicare, a right assumed by the governments of every other major economy. Polls showed support ranging from 80 to an eye-popping 90-plus percent. H.R. 3 was delivered stillborn into Mitch McConnell's Senate in November of 2019. Two years later, when Joe Biden released the massive social-spending and climate-change bill dubbed Build Back Better, H.R. 3's reforms were nowhere to be found. And at every level of government, Pharma's endless river of money continues to flow, the widest, steadiest current of lobbying largesse the capitol has ever known. In 2021, the industry reported spending $124 million on a fleet of 846 lobbyists, roughly two for every member of Congress. Sixty-five percent were former government employees. Pharmaceutical manufacturers are part of a larger coalition that includes the insurance, medical-device, and hospital industries. Its combined resources flow downstream through dozens of lobbying firms, communications shops, and front groups. "If a freshman Democrat so much as signs a letter related to drug prices, the lobby hammers them with phone calls and meeting requests, completely locking up the calendar," says Alex Lawson, executive director of Social Security Works. "The calls come in from ex-Democratic officials and staffers, so they have to take the meetings."
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A foundation representing the vaccine maker BioNTech has been accused of seeking to undermine the World Health Organization's initiative to bring covid vaccine manufacturing to the African continent. The kENUP Foundation, a consultancy hired by BioNTech, has claimed that WHO's hub, which is creating a covid-19 mRNA vaccine that African companies can make, is unlikely to be successful and will infringe on patents, documents obtained by The BMJ have shown. Instead, they show kENUP promoting BioNTech's proposal to ship mRNA factories housed in sea containers from Europe to Africa, initially staffed with BioNTech workers, and a proposed new regulatory pathway to approve the vaccines made in these factories. The novel pathway has been described as paternalistic and unworkable. The move threatens the pan-African venture backed by WHO that seeks to scale up African production of lifesaving vaccines from 1% to 60% by 2040. WHO's technology transfer hub, launched in June 2021 and based in South Africa, uses publicly available information to recreate Moderna's vaccine, to teach companies and scientists across the continent how to use mRNA technology. It will then develop a comparable vaccine, which, if successful in clinical trials and approved by regulators, it will manufacture industrially. In a document sent to South African government officials after a visit to the country on 11-14 August last year, the kENUP Foundation said that the hub's activity should be stopped.
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Pfizer made nearly $37bn (Ł27bn) in sales from its Covid-19 vaccine last year – making it one of the most lucrative products in history – and has forecast another bumper year in 2022, with a big boost coming from its Covid-19 pill Paxlovid. The US drugmaker's overall revenues in 2021 doubled to $81.3bn. The bumper sales prompted accusations from campaigners of "pandemic profiteering". The group Global Justice Now said the annual revenue of $81bn was more than the GDP of most countries. Pharmaceutical companies have been accused of not sharing the recipe for their vaccines, which would enable drugmakers in poorer countries to produce cheaper versions of them. Global Justice Now pointed out that Pfizer's Covid-19 jab was invented by BioNTech, supported by ₏100m (Ł84m) in debt financing from the publicly owned European Investment Bank and a ₏375m grant from the German government. Tim Bierley, a pharma campaigner at the group, said: "The development of mRNA vaccines should have revolutionised the global Covid response. "But we've let Pfizer withhold this essential medical innovation from much of the world, all while ripping off public health systems." According to Reuters, Pfizer has sold the vaccine to African countries at $3 to $10 a shot. It has indicated that a non-profit dose costs just $6.75, or Ł4.98, to produce, but it has reportedly charged the NHS Ł18 a dose for the first 100m jabs bought and Ł22 a dose for the next 89m, totalling Ł3.76bn ... amounting to an eye-watering 299% mark-up.
Note: If big Pharma really cared about public healthy, don't you think they'd be willing to sacrifice some of their huge profits and charge much less for their injections? Unfortunately, it's the old story of the rich get richer and the rest are left behind. For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma profiteering from reliable major media sources.
Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company's COVID-19 vaccine, a litigation move that plaintiffs who are suing for the data say is premature. Pfizer's lawyers at DLA Piper told U.S. District Judge Mark Pittman on Jan. 21 it wanted a role in the proceedings to help the FDA avoid "inappropriately" disclosing trade secret and confidential commercial information. On Tuesday night, the group of doctors and scientists who sued last year over public access to the FDA's Pfizer licensing records said in a court filing that the company's bid to jump into the lawsuit was untimely because the plaintiffs have not challenged any redactions to requested records. Earlier this month, the judge ordered a fast-track release of hundreds of thousands of documents, calling the case "of paramount public importance." U.S. government agencies control the release of information under federal public-records laws, but companies can challenge and even sue to block the disclosure of certain details. The FDA earlier drew criticism over its plan to release 500 pages a month in response to the lawsuit from Public Health and Medical Professionals for Transparency, a production schedule that would take more than 50 years to complete. In its filing, Pfizer said the company supports public disclosure of FDA records "to promote transparency and the public's confidence in the vaccine."
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Mark Cuban has opened up a new online pharmacy to help make generic drugs more affordable. The Mark Cuban Cost Plus Drug Company (MCCPDC) officially launched last week, claiming to offer the "lowest prices on 100 lifesaving prescriptions, according to a press release. The company is able to offer lower prices because it's a registered pharmaceutical wholesaler, meaning MCCPDC can "bypass middlemen and outrageous markups," per the press release. "The pharmacy's prices reflect actual manufacturer prices plus a flat 15% margin and pharmacist fee," the press release states. The company also "refuses to pay spread prices" to pharmacy benefits managers, which manage prescription drug benefits on behalf of health insurers. One of the medications available is Imatinib, a leukemia treatment that has a retail price of $9,657 a month and costs around $120 a month with a common voucher, per the press release. However, the MCCPDC offers a steep discount, making the drug available for $47 per month. Two other notable prescriptions available at a significantly reduced price are Mesalamine, used for ulcerative colitis treatment, as well as gout treatment drug Colchicine. "Not everyone sets the goal of being the lowest cost producer and provider," the billionaire [said]. "My goal is to make a profit while maximizing impact." "We will do whatever it takes to get affordable pharmaceuticals to patients," CEO Alex Oshmyansky said.
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In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, [the] data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public–and are likely to remain that way for years to come. This is morally indefensible for all trials, but especially for those involving major public health interventions. Pfizer's pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data. And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date. The lack of access to data is consistent across vaccine manufacturers. Regulators and public health bodies could release details such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2. Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.
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