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Seniors could be scammed by fake imitations of various anti-aging products

Are your various anti-aging products purified, safe, and pharmaceutical or food grade? The makers and distributors of a variety of fraudulent anti-aging products count on people who are looking for treatments and medications to slow the aging process and/or make them look more attractive to keep or attract a mate, a job, or social confidence.

Seniors could be scammed by fake imitations of various anti-aging products.
Anne Hart, photography.

You can check with the National Council on Aging (NCOA) to see more information on bogus anti-aging and homeopathic remedies that do absolutely nothing. These fake products ruin the reputation of highly qualified homeopathic health care professionals who use products also used by physicians who are trained in homeopathy, are certified master herbalists who know the side effects of any herbs used, and others in the holistic, functional, and integrated medical professions trained, certified, and licensed in their work.

Seniors need to be aware of fake imitations and the general quality of various anti-aging products

Beware of fraudulent anti-aging products such as fake imitations of the product, Botox®. Botulism neurotoxin, which is one of the most toxic substances known to science, if not prepared correctly and becomes a bad batch, can have health consequences far beyond wrinkles, thinning lips, or sagging neck muscles. Botox is purified toxin that is taken from the bacteria that cause botulism.

One case involving fake botox in Arizona netted its distributors (who were convicted and jailed in 2006) $1.5 million in barely a year. Botox scams frighten people, as renegade labs creating versions of the real thing may still be working with the root ingredient.

The reason for the fake products is there is money in the anti-aging business

Check out sites such as "State: Doctors plead guilty in fake Botox case," Botulism disaster uncovers fake Botox market.(Practice Trends), and the YouTube videos, Plastic Surgery Group Pleads Guilty In Fake Botox Case - YouTube" and "Real Or Fake Botox, How Do I Determine The Difference? - YouTube."

You may also wish to read the article in the Healthy Body Daily, "Dr. Oz Botox | Fake Botox In Clinics Up By At Least 20 Percent." Also see, "Dr. Oz Botox: Fake Botox & The Dangers Of Botox." The article focusing on an interview with Dr. Oz and Dr. Bryan Liang in one segment of the Dr. Oz show, reported that the FDA is seeing a 20 percent increase in fake botox inside clinics, according to the article.

Another segment featured Dr. Oz speaking with Dr. Arthur Perry, the person Dr. Oz trusts the most on this botox. Dr. Perry also spoke about how botox has changed the face of aging in America.

FDA-approved botox versus FDA-removed internet-bought fake raw botulinum toxin

In one case metioned in the Healthy Body Daily article, instead of being injected with the FDA approved injection the FDA found out certain patients were injected with raw botulinum which is a toxin that those patients found on the Internet, a product which the FDA removed from 200 doctors offices throughout the U.S. Raw botox is made from raw botulinum toxin.

Dr. Bryan Liang also joined Oz in this segment and reported that in 2011 the FDA saw a 20 percent increase in clinics using fake botox. Patients need to consider the ethics of any given clinic.

Dr. Liang explained that a billionth of an ounce of botulism can kill. Dr. Liang told Dr. Oz before getting botox you need to be an informed consumer. Find your information from professionals. If you're online, use validated, credible sites which you can find at the site called Safe

The Department of Justice's news about the unlawful promotion of Botox®

Be aware of off-label promotion of various anti-aging solutions. When it comes to anti-aging gadgets, cosmetic surgery, or various types of treatments, if the price is too good to be true, walk away. If it says it’s $99, when it should cost hundreds more, walk away. Check out the September 1, 2010 Department of Justice, Office of Public Affairs news release, "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®."

American pharmaceutical manufacturer Allergan Inc. has agreed to plead guilty and pay $600 million to resolve its criminal and civil liability arising from the company’s unlawful promotion of its biological product, Botox® Therapeutic, for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced in a September 1, 2010 news release.

The resolution includes a criminal fine and forfeiture totaling $375 million and a civil settlement with the federal government and the states of $225 million. Also see the October 4 , 2011 article from the Personal Injury Blog, Allergan To Pay $600 Million for Botox off Label Promotion of its best-selling Botox..

Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a biological product. After the FDA approves the product as safe and effective for a specified use, any promotion by the manufacturer for other uses – known as “off-label” uses – renders the product misbranded.

Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, and Sally Quillian Yates, U.S. Attorney for the Northern District of Georgia, today announced the filing of a criminal information against Allergan for promoting Botox® for headache, pain, spasticity and juvenile cerebral palsy – none of which were approved by the FDA. According to the criminal information, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses, noted the Sept 2, 2010 Dept. of Justice's news release.

The FDA approved Botox® in 1989 to treat crossed eyes and involuntary eyelid muscle contraction

In 1989, the FDA approved Botox®, a prescription biological product containing botulinum toxin type A, a purified neurotoxin, to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction). In 2000 and 2004, approval was given to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating), respectively. In 2010, approval was given to treat adult upper-limb spasticity.

The criminal information alleges that Allergan exploited its on-label cervical dystonia (CD) indication to grow off-label pain and headache (HA) sales. In 2003, Allergan developed the “CD/HA Initiative” as a “rescue strategy” in the event of negative results from its clinical trials to ensure continued expansion into the pain and headache markets. As part of this initiative, Allergan claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.”

Allergan’s off-label marketing tactics also included calling on doctors who typically treat patients with off-label conditions. In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses.

The Department of Justice looked at off-label uses. Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications, according to the Dept. of Justice's 2010 press release.

The Food, Drug and Cosmetic Act

“The Food, Drug and Cosmetic Act protects the public from drugs and biologic products that are not proven to be safe and effective. When drug companies make unsubstantiated and misleading statements about their products, they undermine the Act’s protection of public health,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, according to the 2010 Dept. of Justice's news release. “We will continue to pursue drug companies that violate the Act for their own financial gain.”

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by FDA,” said Sally Yates, U.S. Attorney for the Northern District of Georgia, according to the 2010 news release from the Dept. of Justice.

“Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective. The FDA approval process ensures that pharmaceutical companies market their medications for uses that are proven to be safe and effective, and this case demonstrates that companies that fail to comply with these rules face criminal prosecution and stiff penalties.”

Sentence is not final until accepted by the U.S. District Court

Allergan has agreed to plead guilty to a criminal misdemeanor for misbranding Botox® in violation of the FDCA. Under the plea agreement, the company will pay a criminal fine of $375 million, which includes forfeiting assets of $25 million. Allergan’s guilty plea and sentence is not final until accepted by the U.S. District Court.

“The FDA exists to assure that drugs marketed to the American people are safe and effective” explained Dr. Margaret Hamburg, Commissioner, Food and Drug Administration, in the news release. “The ‘off-label’ promotion of drugs threatens public health and the role of the FDA, which has served our country well and has protected Americans from unsafe and ineffective drugs.”

The civil settlement

As part of the civil settlement, Allergan has agreed to pay an additional $225 million to the federal government and the states to resolve claims that its unlawful marketing practices caused false claims to be submitted to government health care programs such as Medicare, Medicaid, TRICARE, and to the Federal Employees Health Benefit Program, the Department of Veterans’ Affairs, and the Department of Labor’s Office of Workers’ Compensation Programs.

The civil settlement addresses allegations that from 2001 through at least 2008, Allergan promoted Botox for off-label indications that were not medically accepted and therefore not covered by federal health care programs, made unsubstantiated and misleading statements about the safety and efficacy of Botox® for off-label indications, instructed doctors to miscode Botox® claims for uncovered indications using inappropriate diagnosis codes to ensure payment by government health care programs, and provided inducements to doctors to inject more Botox®. The federal share of the civil settlement amount is $210,250,000, and Allergan will pay up to $14,750,000 to states that opt to participate in the agreement.

Whistleblower provision of the False Claims Act

The civil settlement resolves three lawsuits filed in federal court in the Northern District of Georgia under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. As part of today’s resolution, the whistleblowers – Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O'Conner-Masse, and Edward Hallivis – will receive $37.8 million from the federal share of the settlement amount.

This settlement is part of the government’s emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $3.1 billion since January 2009 in cases involving fraud against federal health care programs.

The Justice Department’s total recoveries in False Claims Act cases since January 2009 have topped $4 billion. For further details, check out the Sept 1, 2010 Department of Justice news release, "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®."

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