2022.05.24 00:54 _V_L_ Blast From The Past - Justice Department Announces Largest Health Care Fraud Settlement in Its History: Pfizer to Pay $2.3 Billion for Fraudulent Marketing
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today. Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion. In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company. As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter. Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery. The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General. "Today’s landmark settlement is an example of the Department of Justice’s ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud. It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing," said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice’s approach to law enforcement." "This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,"said Kathleen Sebelius, Secretary of Department of Health and Human Services"The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste." "Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare." "The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes," said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated." "Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner," said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division. "This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk," commented Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment. Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line." "This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs," noted Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky. "This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry," said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. "The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site. We expect this agreement to increase integrity in the marketing of pharmaceuticals." "The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system," said Sharon Woods, Director, Defense Criminal Investigative Service. "This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients." "Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior," said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. "Today’s settlement reminds the pharmaceutical industry that it must observe those standards and reflects the commitment of federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk." "Health care fraud has a significant financial impact on the Postal Service. This case alone impacted more than 10,000 postal employees on workers’ compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of Inspector General. "Last year the Postal Service paid more than $1 billion in workers’ compensation benefits to postal employees injured on the job."Apologies we maimed, damaged and murdered you with our fraudulent products. We promise to never do it again. Which means they will keep doing it over and over and over again until the captured and compromised medical and research communities, BigPharma’s gargantuan advertising recipients in the MSM and the various unconstitutional government agencies stop aiding and abetting in these malfeasances such that patients will no longer be maimed, damaged and murdered with said fraudulent products.
2022.01.07 19:00 AutoModerator Can You Take Augmentin and Alcohol Together?
More than half of all adults in the U.S take at least one prescription medication. For people who are not on prescription drugs, many regularly take over-the-counter medications that do not require a prescription for common medical problems like seasonal allergies. Even if you do not take any medications on a regular basis, chances are that you’ve taken common painkillers such as acetaminophen or aspirin for a headache. All of these drugs, regardless of whether they require a prescription or not, have certain restrictions on what kinds of other drugs can you can take with them, or what food and drink you can consume along with them. Even vitamins and supplements that you take regularly have restrictions on the types of drugs and foods you can consume with them. One of the most common things people look for when taking any drug is whether you can consume alcohol along with it. Many medications that can cause side effects such as drowsiness and dizziness can be exacerbated by drinking alcohol along with it. Other drugs may cause an adverse reaction to occur when combined with alcohol. Therefore, it is extremely important to always check whether the medication you are taking can be safely combined with alcohol. submitted by AutoModerator to SearchReviews [link] [comments] https://preview.redd.it/rmif8k1suq981.jpg?width=1200&format=pjpg&auto=webp&s=a50fdf3e1c959727c2b73aad4bd9518bbc152dbc Antibiotics are one category of prescription drugs that are among the most commonly prescribed medicines annually in the U.S. Antibiotics are drugs that can halt the growth of bacteria that causes infections which may cause serious complications and even lead to fatality if not treated. With the number of hospital admissions due to bacterial infections on the rise in the U.S, the amount that antibiotics are being prescribed is also increasing. Luckily, in most cases, if antibiotics are taken promptly and as directed, they can help clear the infection by getting rid of the harmful bacteria that causes it. Augmentin is a popular antibiotic that is part of the beta-lactam antibiotic group that also includes penicillin, which is very effective in treating bacterial infections. Augmentin is currently on the World Health Organization’s List of Essential Drugs, highlighting its importance as a staple in medical care all over the world. What is Augmentin?Augmentin is a combination of the penicillin-derivative, amoxicillin, and the beta-lactamase inhibitor clavulanic acid. Sometimes, bacteria can acquire resistance towards antibiotics over time, and such antibiotic-resistant bacteria can become notoriously difficult to treat. One way bacteria achieve this antibiotic resistance is by producing certain substances, called beta-lactamases, that can break down the administered beta-lactam antibiotic. Clavulanic acid can prevent the bacteria from being able to produce these substances. Hence, combining clavulanic acid with amoxicillin can treat bacterial infections much more efficiently than just amoxicillin alone. This powerful combination has proven to be effective against bacterial infections that can normally become resistant to the beta-lactam antibiotics (such as penicillins) alone. So, what is Augmentin used for? Augmentin is widely prescribed for infections such as:
Can you take Augmentin and alcohol together?One of the first things you should do is to check whether other drugs that you are taking might interact with Augmentin. To avoid drug interactions, be sure to let your doctor or pharmacist know about current drugs that you are taking. These include over-the-counter drugs that you take regularly too.What about alcohol? Many adults wonder if it is safe to drink alcohol while taking their prescribed course of antibiotics. Is it safe to drink alcohol along with your course of Augmentin? We all know that every drug comes with the risk of experiencing side effects. Taking Augmentin also has common side effects associated with it, such as diarrhea and nausea, and it is important to know whether consuming alcohol along with Augmentin can make each side effects worse. The short answer is that while drinking alcohol with Augmentin may not cause a potentially dangerous reaction to happen, most health professionals do not recommend mixing alcohol with antibiotics. Alcohol can increase side adverse effects such as dizziness, upset stomach, and vomiting that could occur with taking Augmentin. Additionally, alcohol itself can cause dehydration and weaken your immune system, which can both interfere with the normal healing process that is important for clearing a bacterial infection from your body. While taking antibiotics, you should drink plenty of fluids and avoid activities that can prevent you from getting good sleep. Alcohol can interfere with your normal sleeping patterns, so if it prevents you from getting proper rest, this could delay the time it takes for you to get better even though you are taking antibiotics for this purpose. Does alcohol make Augmentin less effective?Drinking small quantities or in moderation is not thought to directly lessen the ability of Augmentin to treat an infection. However, depending on the amount of alcohol that is consumed and the drinking habits of the individual taking it, the levels of antibiotic in the bloodstream could be altered with alcohol. As both alcohol and certain antibiotics are metabolized in the liver, this can impede the ability of the enzymes in the liver to break drown the drug in the body once it is taken, which is important for step for it to work properly. Alcohol consumption could technically cause the antibiotic to be broken down too fast or too little, depending on the drinking habits of the individual. Therefore, while drinking alcohol will most likely not prevent Augmentin from working, if it is something that you can avoid, it is recommended.It should also be noted that although taking Augmentin and alcohol together may not be considered dangerous, alcohol should never be mixed with certain antibiotics such as metronidazole (Flagyl), tinidazole (Tindamax), sulfamethoxazole (Bactrim), cefotetan (Cefotan) or linezolid (Zyvox). Mixing alcohol with these antibiotics can cause very serious adverse reactions in the individual to occur, such as a rapid heart rate, difficulty breathing, chest pain, nausea, and vomiting. Most medications that may have an interaction with alcohol have a label that clearly states ‘Avoid Alcohol’ on them, so this should help serve as a reminder if you are prescribed these medications. As always, your personal medical history may also play a factor in whether it is safe to drink alcohol while taking Augmentin. The presence of certain pre-existing conditions in some people may weaken the immune system or cause other medical problems in people when they are sick from a bacterial infection. In these cases, you should check with your doctor on whether it is safe to drink alcohol while you are taking antibiotics. Additionally, the severity and location in the body of the infection may require taking higher doses of the antibiotic, which could increase your risk of experiencing Augmentin side effects. In these cases, mixing alcohol with the antibiotic may worsen these adverse effects. Along with alcohol, you should also check whether any drugs that you are currently taking could interact with Augmentin. Your doctor or pharmacist should be able to help you with this. More information on Augmentin dosage, a complete list of side effects, and potential drugs interactions can be found here. How to save on AugmentinA prescription is always required to purchase Augmentin. If you develop symptoms of a bacterial infection and consult your doctor, you may be given Augmentin to treat the infection. It is important that antibiotics are taken exactly as directed by your doctor. You should take the entire course of antibiotics, even if your symptoms resolve before your prescribed course is over to prevent the infection from recurring or from becoming resistant to Augmentin in the future. Augmentin is a brand name that can also be purchased as a generic form as amoxicillin and clavulanate potassium.Finding ways to save on the cost of taking antibiotics like Augmentin are possible. Drug coupons are available from online that can help you substantially reduce the cost of buying Augmentin. So, if you are prescribed Augmentin and are wondering whether to have that glass of wine that is a part of your nightly routine, the bottom line is that while it may not cause you harm, it certainly won’t help you get better either. Instead, focus on getting proper rest, drinking plenty of water-based fluids and eating well to help you get better faster, and allow Augmentin to work as well as it can in clearing the bacterial infection. |
2020.04.07 09:22 ActavisSlinger What’s up with our profession trying to be vigilante cops, I’m the gate keeper you shall not pass when we have dispensed off label most likely everyday we have practiced?
2011.01.01 00:26 FlagBattery Quadriplegic in dire need of anti-biotics, pleads for help in the most unlikely of places
2010.03.22 16:37 baddna7 Can someone explain to me why I should get excited about this new health care plan when I hear nothing about drug company price regulation.