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Tag: Big Pharma

  • The 6 Worst Health Scandals of the Past 25 Years

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    In medicine, there’s almost no such thing as a free lunch. Just about every drug or intervention will have its side effects.

    Ideally, rigorous studies and the regulatory process will ensure that an approved drug’s benefits clearly outweigh any potential harms. But sometimes, researchers (and patients) will uncover side effects that went unnoticed during the approval process. Other times, more rarely, a drug’s maker is revealed to have buried incriminating information about their drug’s harms from the public or to have created a product that doesn’t work at all as intended. And when that happens, a bad or ineffective treatment can spark a major scandal.

    There’s no shortage of pharmaceutical scandals that have occurred over the years, but to keep things short, let’s just focus on some of the biggest ones to have happened in this quarter-century.

    1. Johnson & Johnson’s talcum powder products

    For decades, people had unsuccessfully tried to sue J&J over its consumer products containing talc, particularly baby powder, claiming that the products had contributed to their cancers.

    In 2018, however, an explosive report from Reuters found the company had hidden evidence that the talc it used could sometimes contain detectable levels of asbestos, a known carcinogen. The report helped fuel a new wave of lawsuits and growing public distrust in the company’s baby powder products. In the years since, the company has repeatedly lost civil suits over its talc products, some totaling into the billions, and its appeals continued to fail, even before the Supreme Court.

    Though J&J has maintained that its products are safe, the company eventually removed talc from all its powder brands (instead using cornstarch), tried and failed to cover its liability over these lawsuits by having a subsidiary declare bankruptcy, and even this year has continued to lose court cases tying its products to people’s cancer.

    Interestingly enough, though asbestos is known to cause cancer, past research hasn’t found a clear link between talc as a whole (including asbestos-free talc) and cancer, and there remains some disagreement over the extent of the risk posed by talcum powder products. The American Cancer Society states that if talc can raise a person’s risk of ovarian cancer (the primary type of cancer linked to talc), the “overall increase is likely to very be small” for an individual woman. The World Health Organization has stated that asbestos-containing talc should be considered carcinogenic, while talc in general is “probably carcinogenic.

    2. Biogen and the Alzheimer’s drug that wasn’t

    In June 2021, the FDA approved Biogen and Eisai’s antibody-based Alzheimer’s drug Aduhelm. At first glance, the approval should have been good news: the first drug of its kind, and one intended to actually target a key driver of the degenerative disorder, beta amyloid. But in actuality, it was anything but.

    In a rare move at the time, the FDA went against the recommendations of its expert advisory panel, who voted against approval. The outside experts rightly noted that the data supporting the drug’s effectiveness was mixed at best. The FDA also granted Aduhelm accelerated approval, a special category that requires less rigorous evidence. Media outlet STAT News later uncovered an unusually friendly relationship between top Biogen employees and FDA officials, which prompted a Congressional investigation into the matter. And to add insult to injury, Biogen initially set Aduhelm’s list price at $56,000 a year—a cost high enough to potentially devastate the pockets of patients and Medicare if the drug saw widespread use among older Americans.

    Many doctors soon rebelled against the approval, refusing to prescribe it to their patients, while Medicare decided to severely restrict its coverage of the drug. Biogen eventually gave up trying to make Aduhelm a thing, following years of poor sales, and pulled the drug from the market in early 2024.

    This saga does have a bit of a happy ending, at least. There have been other similar drugs developed and approved in recent years, and unlike Aduhelm, these drugs do seem to have a real, if still modest, effect on treating the condition.

    3. Purdue Pharma and OxyContin

    Purdue Pharma has perhaps become the most infamous poster child for the opioid crisis.

    Bottles of Oxycontin. © PureRadiancePhoto via Shutterstock

    Its blockbuster drug, OxyContin, helped fuel growing rates of opioid use disorder following its release to the public in 1996. And though there are many drivers of the crisis, including the proliferation of more potent agents like fentanyl in later years, the company did eventually admit to downplaying the addictive risk of its products, paying doctors illegal kickbacks to prescribe their drugs, and turning a blind eye to the widespread diversion of its drugs from pharmacies to the black market.

    Following a glut of civil and federal lawsuits over OxyContin, Purdue Pharma shuttered its doors, and its sole owners—the Sackler family—agreed to pay out more than $4 billion as part of a far-reaching settlement in 2021. The courts bumped this up to $6 billion in 2023. That settlement, however, also provided immunity from further civil charges against the Sacklers themselves. And though the situation has finally started to improve as of late, roughly 50,000 Americans still died from opioid overdoses last year.

    4. Martin Shkreli’s drug price surge

    Sometimes the scandals aren’t about the drugs themselves, but what they’re being sold for.

    In 2015, Martin Shkreli became public enemy number one when his company, Turing Pharmaceuticals, bought the anti-parasitic and anti-HIV drug Daraprim and raised its $13.50 price tag per pill by over 5,000 percent. Shkreli’s cocky, unrepentant attitude toward his many critics earned him the nickname of the “Pharma bro.”

    Ironically enough, his initial downfall had nothing to do with Daraprim. Soon after he became infamous, federal prosecutors in New York charged Shkreli with securities fraud, and in 2017, he was convicted and sentenced to seven years of federal prison.

    Martin Shkreli
    Martin Shkreli speaks to the press after the jury issued a verdict in his case at the U.S. District Court for the Eastern District of New York, August 4, 2017.  © Drew Angerer via Getty

    Though Shkreli was released early in 2022, his company’s management of Daraprim did later come back to bite him. In 2020, the FTC and others sued the company, now called Vyera Pharmaceuticals after Shkreli’s imprisonment, alleging that it carried out an “elaborate anticompetitive scheme” to maintain its monopoly on the drug. The company reached a settlement with the FTC a year later, and the legal battle eventually required Shkreli himself to pay out a $64 million fine and to stay away from the pharmaceutical industry entirely. In 2023, Vyera declared bankruptcy and sold the rights to Daraprim. Last year, the U.S. Supreme Court snubbed Shkreli’s attempt to dismiss his personal fine and ban.

    Don’t feel too bad for Shkreli, though. Since his release from prison, he’s been busy trying to shill crypto and AI knockoffs of WebMD.

    5. Abbott’s tainted baby formula

    Powderedbabyformula
    Baby formula powder in a measuring scoop © Strigana via Shutterstock

    In early 2022, the FDA warned families to stay away from certain powdered baby formulas produced by the company Abbott Nutrition. The products, it turns out, were contaminated by Cronobacter bacteria.

    Several children were hospitalized, and two infants who had consumed the products later died. Abbott issued a widespread recall of its products and shut down its formula production facility in Sturgis, Michigan. The FDA’s investigation concluded that Abbott had failed to maintain sanitary conditions and that the facility had at least eight recent instances of Cronobacter contamination dating back to 2019.

    It would take four months for the company’s Sturgis plant to reopen, following an agreement with the FDA to overhaul its safety practices, the length of which helped contribute to a nationwide formula shortage that year. Lawmakers on both sides also criticized the FDA for its delayed response to the crisis, since the agency first caught wind of potential issues as early as September 2021.

    Though there haven’t been similar recalls or reported outbreaks since, an extensive ProPublica report in April 2025 interviewed workers who claimed that the Sturgis plant continues to have serious safety and sanitary risks to this day. One employee reported what they found to the FDA, but it’s unclear whether the new Trump administration will take action.

    6. Elizabeth Holmes and Theranos

    Elizabeth Holmes founded the company Theranos in 2003. It centered around the development of a device intended to make blood tests easier than ever. With just a few drops of blood from a single finger prick, Holmes claimed, her company’s “Edison” device could accurately detect a litany of health conditions. By the mid-2010s, Holmes’ marketing of Theranos had allowed her to become a darling of the biotech world: a young, self-made entrepreneur styled after Steve Jobs, who at one point was worth nearly $5 billion.

    The trouble was, as the world eventually found out, it was all based on falsehoods. Starting in late 2015, Wall Street Journal reporter John Carreyrou exposed the fraudulent practices of Holmes and Theranos. Though Holmes had struck a partnership with retail chain Walgreens in 2013 to provide the Edison device to its customers, the Edison could simply never do what Holmes claimed it could. And eventually, the company secretly resorted to using other commercially available machines to perform most of its blood testing services.

    Holmes’ deception didn’t just mislead investors; several people reported that the faulty test results provided by Theranos made them fearful about having medical conditions they didn’t actually have, such as HIV, or otherwise harmed their health.

    Holmes was convicted of investor fraud and other charges over Theranos in 2022 and was sentenced to an 11-year stint in prison (later reduced by two years), while her co-executive and one-time romantic partner Ramesh “Sunny” Balwani was sentenced to nearly 13 years the next month. As of this year, she’s made her return to social media (via having someone else post her words).

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    Ed Cara

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  • Hidden camera tests reveal pitfalls in Colorado law making EpiPens more affordable

    Hidden camera tests reveal pitfalls in Colorado law making EpiPens more affordable

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    DENVER — After learning multiple pharmacies were not complying with a new Colorado state law making EpiPens more affordable, Denver7 Investigates conducted a hidden camera operation at multiple locations and brought the footage to the bill’s co-sponsor. The test uncovered confusion about the bill and problems in properly informing pharmacies around the state, resulting in the delay of affordable, life-saving medication.

    On January 1, House Bill 1002 made epinephrine injectors, commonly known by the brand EpiPen, available for $60 to qualifying residents. This is considerably lower than the up to $700 price tag a two-pack can cost for those without insurance.

    Jackson Pugh, a high school rugby player, needs access to EpiPens due to a life-threatening peanut allergy.

    “It’s still kind of nerve-wracking. Like thinking if I eat something wrong that it could be life-threatening,” he said.

    Pugh is one of 500,000 Coloradans who rely on epinephrine to be the first line of defense during an allergic reaction. He and his mother testified in front of state lawmakers last year, helping to pass HB 23-1002.

    Specifically, the new bill addresses the “rising costs of epinephrine auto-injectors make this life-saving medication difficult or impossible to obtain for many people,” and serves to “establish an affordability program to ensure Colorado residents have greater access to epinephrine.”

    Two months after the program’s rollout, multiple sources have come forward, telling Denver7 Investigates they could not find a pharmacy that honored the cost cut. Denver7 Investigates went undercover at multiple locations in the metro area including Walmart, Walgreens, King Soopers, Safeway, and CVS, to find out why the law was being followed.

    “Us as pharmacists, and us as a company, don’t know what to do,” said a manager at a Walgreens location when asked by a Denver7 producer if they honored the $60 value.

    “I honestly think most places just didn’t know how to handle it,” said a pharmacy employee at one CVS location.

    “You’re my first person to do this… so I don’t know what I’m doing yet,” said a Walmart pharmacist.

    Multiple employees and pharmacists expressed confusion to Denver7 Investigates. Some said they had no way to bill patients or process payments at the cheaper rate, others blamed the medication’s manufacturers for not honoring the new price.

    “The [Colorado] Board of Pharmacy just released a thing… right now, they don’t have an answer. So right now, we’re all waiting to see what the manufacturers do,” the Walgreens manager said.

    “It says to just fill this out and bring it here and it seems like it’s like on the pharmacies to just like override the price, but we can’t, like we’re not getting any type of payment reimbursement, nothing from the government,” said one manager at a Walmart pharmacy, who spent over an hour during her lunch break to try and learn more about the law. “There’s no direction as to what we are supposed to do other than try to contact the manufacturer.”

    Despite qualifying for application and presenting it at multiple pharmacies, 70% of the locations visited by Denver7 producers lacked either the knowledge or ability to sell a pair of EpiPens for the discounted price. Denver7 Investigates took the hidden camera footage to Democratic State Senator Dylan Roberts, the bill’s Co-Sponsor, who admitted the law is not working.

    Hidden camera tests reveal pitfalls in Colorado law making EpiPens more affordable

    “She [Walmart manager] clearly understands the frustration with the lack of accountability from these big pharma companies and a lack of information of how she can fix the problem,” Roberts said. “She’s trying to do the right thing.”

    Senator Roberts said both he and the governor, who signed the legislation into law last June, expected the law was being followed. He told Denver7 Investigates, it’s the state’s job to make sure.

    “The state government oversees pharmacies and pharmacists,” he said. “I’ve run this program through the Board of Pharmacy and the Division of Insurance.”

    However, some pharmacy locations visited during the hidden camera test did follow the law. Pharmacists at a Safeway in Arapahoe County and a King Soopers in Denver understood how to honor the price change, selling Denver7 Investigates two epinephrine injectors at the correct price.

    “We just need to make a few phone calls, but it’s not like really complicated,” the Safeway pharmacist said, telling a Denver7 producer the medication is available for $60 at any Safeway location, as long as it is in stock.

    “It gives me hope,” Roberts said, after learning Denver7 was successful at a few locations. “I mean it’s a bright spot in a pretty tough set of videos.”

    Roberts concluded the evidence from the undercover videos would help him to address the problem and hold people accountable.

    “Now when the lobbyists come and say it’s not our fault, I can point to the video and say ‘Yes it is. This is what’s happening in pharmacies across the state. You are the manufacturer, you need to comply with the law and help the pharmacists do their job,’” he said. “We can fix it. I am sad about the two and a half months we lost.”

    Senator Roberts tells Denver7 Investigates, that he and Attorney General Phil Weiser are now considering enforcing the $10,000 penalty against injector manufacturers. Roberts is also pushing for better communications from his state agencies to inform pharmacies.

    Denver7 Investigates reached out to the Colorado Retail Council for comment and perspective on behalf of pharmacies. They have not responded to our questions.

    There is currently a lawsuit in process from at least one manufacturer against the state of Colorado in an effort to fight the cost cut.


    Denver7

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    Tony Kovaleski

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  • Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

    Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

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    The U.S. Food and Drug Administration last week announced the voluntary recall of a medicine used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy after the manufacturer of the drug revealed that the wrong pills were found in packages of the medication. The recall covers one lot of the drug Zenzedi, an ADHD and narcolepsy medication manufactured by Massachusetts-based Azurity Pharmaceuticals.

    In a notice about the recall, the FDA noted that a pharmacist had reported finding pills of an antihistamine, carbinoxamine maleate, in a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and covers packages of Zenzedi 30 milligram tablets with lot number F230169A and an expiration date of June 2025.

    The recalled medication was distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers have reportedly pulled the drug from their shelves to comply with the recall. Customers who purchased packages of the recalled lot of Zenzedi are urged to return any remaining pills to the place of purchase. Patients who take the mislabeled medication and have adverse reactions are encouraged to see their doctor. 

    Drugs Have Opposite Effects

    The two drugs have opposite effects when taken, according to a report from CBS News. Carbinoxamine maleate is an antihistamine that is used to treat allergies and has a sedative effect on some patients, while Zenzedi, a brand name for the drug dextroamphetamine sulfate,  is a stimulant that generally increases a patient’s attentiveness. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime drowsiness, and ADHD.

    The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will experience undertreatment of their symptoms. Patients can also have a potentially deadly elevated risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder, among other symptoms, according to the FDA’s recall notice.                                           

    “Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA wrote in a notice about the recall. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”

    Azurity Pharmaceuticals sent recall notification letters to drug wholesalers on January 4 via an overnight letter and has arranged for the return of all affected product at the wholesale level. The company said that no reports of serious injury have been made as a result of the mixup.   

    Recall Comes During Shortage of ADHD Meds

    The Zenzedi recall comes in the midst of a nationwide shortage of medications used to treat ADHD. The shortage has been affecting supplies of the drug Adderall since a manufacturer experienced production delays in Fall 2022, according to a report from CNN.

    At least 11 manufacturers of Adderall or generic versions of the drug were listed on the FDA’s shortage list in September 2023. The shortage of ADHD medication has left many patients struggling to fill their prescriptions, according to healthcare professionals. 

    “A lot of the young people that I’ve been treating have had difficulties getting their medications month to month,” Dr. Warren Ng, a professor of psychiatry at Columbia University Medical Center who also serves as president for the American Academy of Child and Adolescent Psychiatry, told CNN.

    When taking their prescribed medication, many patients with ADHD are able to function better. But when they run out of their medication, it can have a tremendous impact on their self-esteem.

    “I’ve seen kids who want to drop out of school, don’t want to continue with their educational path or drop out of college suddenly making the honor roll,” Ng said. And “instead of seeing, being seen as being lazy or dumb or slow, they can envision themselves really utilizing all of their mental, psychological and intellectual abilities to really see themselves for who they are, which is so much more.”

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    A.J. Herrington

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