Botox Fraud - Are You Being Poisoned?

  1. theirishobserver. profile image60
    theirishobserver.posted 8 years ago

    The pharmaceutical company Allergan has agreed to pay $600 million in criminal and civil penalties for aggressively promoting its flagship drug Botox for uses not approved by the Food and Drug Administration (FDA), for paying kickbacks to doctors, and for other violations of the False Claims Act.

    Today’s announcement represents the culmination of a complex, three-year investigation by the FBI and our federal partners in which millions of documents and dozens of hours of electronic evidence were collected.

    “This case sends a clear message,” said Brian Lamkin, special agent in charge of our Atlanta Division, “that the FBI will not allow manufacturers to promote their prescriptions or products for uses beyond their intended purpose.”

    Botox is widely known for its cosmetic use, but the FDA has approved the drug for therapeutic treatment in a few rare cases. Still, for nearly a decade, Allergan—an international company based in California—made it a top corporate priority to maximize sales in the lucrative off-label market. The company promoted the drug to treat headaches, pain, spasticity, and juvenile cerebral palsy—all without FDA approval.


    "It all started when citizens came forward to report wrongdoing."

    Scott Stephan
    FBI Special Agent


    As part of that promotion, Allergan provided kickbacks to doctors in the form of cash, travel, and meals and held seminars instructing physicians on how to bill Medicare for off-label procedures. The company also made false and fraudulent statements regarding Botox’s efficacy for those off-label treatments “even when there was little clinical evidence that these uses were effective,” said Sally Yates, U.S. Attorney for the Northern District of Georgia.

    Our investigation began in 2007 in Atlanta, when a doctor and an Allergan employee came forward to complain about Allergan’s practices. “We took a look at the numbers involved in the case and knew immediately that it was not regional but national in scope,” said Special Agent Mike Badolato. Joining in the investigation were the FDA’s Office of Criminal Investigation and the Health and Human Services Administration’s Office of Inspector General.

    Agent Badolato and Special Agent Scott Stephan, who both specialize in health care fraud investigations, traveled the country gathering evidence in the case. “One of the benefits the FBI brings to the table in health care fraud investigations like this is the resources we can marshal,” Stephan said. “We have the ability to travel and to cover leads almost anywhere.”

    U.S. Attorney Yates said Allergan made “hundreds of millions of dollars” promoting the off-label uses of Botox. And Tony West, Assistant Attorney General for the Department of Justice’s Civil Division, pointed out that this is not a victimless crime.

    “When our public health care programs are burdened with fraudulent charges, it drives the cost of health care up for all of us—consumers pay more in premiums, companies pay more to cover their employees,” West explained. “And when a pharmaceutical manufacturer violates the integrity of the drug approval process established by Congress and the FDA by paying kickbacks to encourage the off-label use of an unapproved drug, that not only undermines the judgments of health care professionals, it also threatens to put patients’ health and safety at risk.”

    Agents Stephan and Badolato, on hand for today’s announcement in Washington, were pleased with the outcome of the case. “This was a good team effort,” Stephan said. “And it all started when citizens came forward to report wrongdoing.”


This website uses cookies

As a user in the EEA, your approval is needed on a few things. To provide a better website experience, uses cookies (and other similar technologies) and may collect, process, and share personal data. Please choose which areas of our service you consent to our doing so.

For more information on managing or withdrawing consents and how we handle data, visit our Privacy Policy at:

Show Details
HubPages Device IDThis is used to identify particular browsers or devices when the access the service, and is used for security reasons.
LoginThis is necessary to sign in to the HubPages Service.
Google RecaptchaThis is used to prevent bots and spam. (Privacy Policy)
AkismetThis is used to detect comment spam. (Privacy Policy)
HubPages Google AnalyticsThis is used to provide data on traffic to our website, all personally identifyable data is anonymized. (Privacy Policy)
HubPages Traffic PixelThis is used to collect data on traffic to articles and other pages on our site. Unless you are signed in to a HubPages account, all personally identifiable information is anonymized.
Amazon Web ServicesThis is a cloud services platform that we used to host our service. (Privacy Policy)
CloudflareThis is a cloud CDN service that we use to efficiently deliver files required for our service to operate such as javascript, cascading style sheets, images, and videos. (Privacy Policy)
Google Hosted LibrariesJavascript software libraries such as jQuery are loaded at endpoints on the or domains, for performance and efficiency reasons. (Privacy Policy)
Google Custom SearchThis is feature allows you to search the site. (Privacy Policy)
Google MapsSome articles have Google Maps embedded in them. (Privacy Policy)
Google ChartsThis is used to display charts and graphs on articles and the author center. (Privacy Policy)
Google AdSense Host APIThis service allows you to sign up for or associate a Google AdSense account with HubPages, so that you can earn money from ads on your articles. No data is shared unless you engage with this feature. (Privacy Policy)
Google YouTubeSome articles have YouTube videos embedded in them. (Privacy Policy)
VimeoSome articles have Vimeo videos embedded in them. (Privacy Policy)
PaypalThis is used for a registered author who enrolls in the HubPages Earnings program and requests to be paid via PayPal. No data is shared with Paypal unless you engage with this feature. (Privacy Policy)
Facebook LoginYou can use this to streamline signing up for, or signing in to your Hubpages account. No data is shared with Facebook unless you engage with this feature. (Privacy Policy)
MavenThis supports the Maven widget and search functionality. (Privacy Policy)
Google AdSenseThis is an ad network. (Privacy Policy)
Google DoubleClickGoogle provides ad serving technology and runs an ad network. (Privacy Policy)
Index ExchangeThis is an ad network. (Privacy Policy)
SovrnThis is an ad network. (Privacy Policy)
Facebook AdsThis is an ad network. (Privacy Policy)
Amazon Unified Ad MarketplaceThis is an ad network. (Privacy Policy)
AppNexusThis is an ad network. (Privacy Policy)
OpenxThis is an ad network. (Privacy Policy)
Rubicon ProjectThis is an ad network. (Privacy Policy)
TripleLiftThis is an ad network. (Privacy Policy)
Say MediaWe partner with Say Media to deliver ad campaigns on our sites. (Privacy Policy)
Remarketing PixelsWe may use remarketing pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to advertise the HubPages Service to people that have visited our sites.
Conversion Tracking PixelsWe may use conversion tracking pixels from advertising networks such as Google AdWords, Bing Ads, and Facebook in order to identify when an advertisement has successfully resulted in the desired action, such as signing up for the HubPages Service or publishing an article on the HubPages Service.
Author Google AnalyticsThis is used to provide traffic data and reports to the authors of articles on the HubPages Service. (Privacy Policy)
ComscoreComScore is a media measurement and analytics company providing marketing data and analytics to enterprises, media and advertising agencies, and publishers. Non-consent will result in ComScore only processing obfuscated personal data. (Privacy Policy)
Amazon Tracking PixelSome articles display amazon products as part of the Amazon Affiliate program, this pixel provides traffic statistics for those products (Privacy Policy)