Tuesday, November 26, 2019

'Pharmaceutical companies raping patients here in the U.S.': Jury acquits Tulsa neurologist charged with using unapproved Botox

By Curtis Killman Tulsa World
A jury acquitted a Tulsa neurologist on Monday of charges accusing him of billing Medicare for patient treatments with Botox that was not approved for use in the United States.
Dr. Gregory Sinclair Connor, 61, faced up to 10 years in prison had he been convicted of the fraud charges.
“Don’t ever underestimate the power of the government to abuse its citizens,” Connor’s attorney, Mark Lyons, said after the verdict was rendered.
Lyons said he didn’t know exactly what caused the jury to issue the not guilty verdicts.
“I can’t speculate, but what we did submit into evidence in front of the judge was proof on 34 other occasions throughout the U.S., U.S. Attorney’s Offices have declined to prosecute (these types of cases) because there is no prosecutive merit in it,” Lyons said.
“They tried, in my estimation, to make Dr. Connor a test case here for the quote Botox Police unquote, which has been railed against before Congress, in the newspapers and at the FDA,” he said.
U.S. Attorney Trent Shores issued the following statement following the verdict:
“The American justice system is the best in the world, in part because the ultimate verdict is determined through a fair and transparent process established by our Founding Fathers.
“The government must prove its case beyond a reasonable doubt. A defendant is guaranteed the opportunity to see and hear all the witnesses against him and may, if he so chooses, present a defense. Today, the jury returned a verdict of not guilty, and we will respect that verdict.”
Connor denied knowing that his use of the Botox, which prosecutors said was packaged for use in other countries, was illegal.
A grand jury on April 2 initially named Connor in a six-count indictment alleging health care fraud, fraud related to the use of misbranded drugs and aggravated identity theft related to the use of a patient’s identity while committing health care fraud.
On Sept. 5, a grand jury returned a superseding indictment that added 35 counts of health care fraud. Prosecutors dismissed two of the four identity theft counts, leaving a total of 39 counts for trial.
Prosecutors say the investigation into Connor’s activities began in January 2017, when U.S. Customs and Border Protection agents intercepted a package addressed to his practice, Neurological Center of Oklahoma, at 6585 S. Yale Ave. in Tulsa.
The package contained Botox that was labeled differently from Botox approved by the U.S. Food and Drug Administration, prosecutors said.
A subsequent investigation by the FDA found that Connor had been using Botox from sources not approved by the FDA that was destined for other countries, including Pakistan, Malta and Great Britain, according to prosecutors.
Connor said he had sought a cheaper source for the drug in part because his Botox treatments cost more than Medicare would allow and because he believed that the drug’s manufacturer, Allergan, was “immoral.”
Over the course of a year, Connor estimated that he lost about $600 on each Medicare patient he treated with Botox before switching to a cheaper supplier of the drug.
Prosecutors say Connor’s business records indicate that he stopped purchasing Botox directly from Allergan, which was the sole FDA-approved supplier, in 2009.
Prosecutors claimed that Connor bought Botox from an unapproved FDA supplier beginning in 2009. Trial evidence indicated that the Botox at issue was purchased from a company that claimed to be in Canada.
FDA regulations require that Botox used in the U.S. be purchased through a California supplier that has been approved by the FDA, according to testimony from an FDA investigator.
Connor maintained that the Botox he used was safe and effective.
One patient of Connor’s testified that Connor used Botox to treat his muscle spasms.
“He’s been the best doctor I ever had,” said Gordon Couger when asked about Connor.
Couger said he was unaware that the Botox used to treat him in 2014 was not approved for use in the U.S. by the FDA.
“No,” Couger replied when asked if knowing so would change his opinion of Connor. “The shots worked.”
Connor testified Friday that at the time he didn’t know whether the Botox he used had been approved for use in the U.S.
“All I know is the boxes looked exactly the same,” Connor said, adding that he achieved “fantastic results” when he treated patients with the Botox made for other countries.
But Assistant U.S. Attorney Melody Nelson was dubious of Connor’s claim about the legality of his actions.
“If he is not the person who is supposed to know you are supposed to use FDA-approved drugs, who is?” Nelson asked during closing arguments Friday.
Lyons said Connor will continue to treat patients with Botox. But, Lyons said, Connor has been purchasing the drug from the sole FDA-approved source.
“This is just pharmaceutical companies raping patients here in the U.S. and, more importantly, since these were all Medicare patients, just raping the government for excessive fees,” Lyons said.


Tuesday, November 19, 2019

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information


Indication

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

IMPORTANT SAFETY INFORMATION

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months

Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Serious and/or immediate allergic reactions have been reported. These reactions include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).
This product contains albumin taken from human blood. Steps taken during donor screening and product manufacturing processes make the risk of spreading viral diseases extremely rare. In theory, there is also an extremely rare risk of contracting Creutzfeldt-Jakob disease (CJD). No cases of spread of viral diseases or CJD have ever been reported for albumin.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.

Monday, November 4, 2019

Lip Augmentation

Lip augmentation creates fuller, plumper lips and reduces fine wrinkles around the mouth. Lips may be injected with collagen or with fat transferred from another site in the patient's body. Both liquid collagen and fat are absorbed and repeat treatments are necessary to maintain results. Newer, longer-lasting options include implantable materials like AlloDerm and SoftForm.


Technique:


A natural or synthetic biocompatible material, or the patient's own fat, is injected or implanted in the lips. One injection is usually sufficient to produce the desired result, which may be temporary, depending on the material used. Injections may need to be repeated periodically. Proper placement of the injected material is important. AlloDerm, a natural collagen sheet made from donated skin, is inserted through tiny incisions inside the corners of the mouth. Once the AlloDerm implant is in place, it eventually becomes integrated with the natural tissues. Gore-Tex, SoftForm and soft ePTFE are other synthetic implant options.

Further options include:


  • Autologen - injectable dermal implant material made from the patient's own skin.
  • Dermalogen - injectable Human Tissue Matrix (HTM) procured from donor tissue.
  • Fascia - injectable donor tissue made from the dense white connective tissue that supports body structure. Can also be done as a surgical implant.
  • HylaForm - a crystal-clear injectable gel; the hyaluronic acid in Hylaform is similar to that naturally found in the body.
  • Radiance - calcium hydroxylapatite
  • Restylane - crystal-clear injectable gel; the hyaluronic acid in Restylane is very close to that naturally found in the body.
Another augmentation choice is laser lip rejuvenation, which tightens the natural collagen and elastic tissue beneath the lips.