by Linda Bren
…cures Alzheimer's and HIV/AIDS…proven effective in treating over 650 infectious diseases…recognized in scientific journals to be a revolutionary breakthrough in treating arthritis
These health product claims found on the Internet can provide hope for those suffering from painful or debilitating diseases. But they are false claims, leading to false hopes. They are also fraudulent, illegal, and the cause of recent government enforcement actions against the companies that made them.
In the ongoing war against Internet health fraud, federal and state government organizations have united, in an effort dubbed Operation Cure.All, to crack down on unscrupulous marketers who use the Internet to prey on the sickest and most vulnerable consumers.
Operation Cure.All, a partnership of the Federal Trade Commission, the Food and Drug Administration, Health Canada (the Canadian federal health department), and various state attorneys general and state health departments, combines a law enforcement effort with a consumer education campaign.
Almost 100 million adults in the United States use the Internet to find health-related information, according to a poll conducted by the market research firm Harris Interactive. "The Internet provides many benefits. But, its unique qualities--including its broad reach, relative anonymity, and ease of creating new Web sites or removing old ones--pose new enforcement challenges," says Bernard A. Schwetz, D.V.M., Ph.D., acting principal deputy commissioner of the FDA. "FDA and the FTC are working together to protect the public from those who try to take advantage of consumers through this new technology."
In June, the FTC, which developed and leads Operation Cure.All, announced enforcement actions against six companies that fraudulently marketed health products on the Internet. These actions mark Operation Cure.All's fourth group of targeted enforcement efforts to address marketing of unproven health products on the Internet.
Five of the companies have agreed to settle the charges. Settlements included such actions as removal of all unsubstantiated claims for products, warnings about potential dangerous interactions with some prescription drugs, a notice to purchasers with an offer for a full refund, and agreement to pay fines for consumer redress. The FTC has filed a complaint in federal district court against the sixth company.
Among the many false and unsubstantiated claims challenged in these recent cases were promises that:
People could cancel their surgery, radiation or chemotherapy in favor of herbal cures that cost hundreds of dollars;
A device that delivered mild electric current would kill the parasites that cause such serious diseases as cancer and Alzheimer's; and
Those with HIV or AIDS could use St. John's wort as a safe treatment for the disease. (The FDA and FTC warn that St. John's wort may have potentially dangerous interactions with other medications, including some proven HIV/AIDS medications.)
"It's bad enough when someone, with little or no evidence, touts unproven remedies to vulnerable populations such as people infected with HIV or AIDS," says Walter H. Carr, partnership council chairman of the National AIDS Health Fraud Task Force Network. "It's even more frightening when they do so despite--and without so much as a mention of--emerging risks that those remedies pose to the very people to whom they are pitching their sale. St. John's wort and protease inhibitors: They don't mix."
Since the launch of Operation Cure.All in 1999, the FDA and FTC have won a number of battles against Internet health fraud. The FDA's efforts to curtail online marketing of unapproved drugs have resulted in at least 12 product seizures, 11 product recalls, 43 arrests, and 22 convictions. The FDA continues to investigate more than 80 incidences of Internet health fraud and unapproved drug products.
Since 1999, the FTC has brought 13 law enforcement actions against Internet marketers for unsubstantiated health claims. One case resulted in a $1 million settlement with the maker of a shark cartilage product promoted as a cure for cancer. Another settlement required consumer refunds for electronic devices and herbal remedies that were sold as cures for cancer, AIDS, Gulf War syndrome, and many other diseases. All were required to remove their bogus claims from the Web. In addition, the FTC estimates that more than 100 other Web sites have taken down their sites or removed their claims after the FTC contacted them.
"Consumers should avoid Web sites that promise quick and dramatic cures for serious diseases," says Howard Beales, director of the FTC's Bureau of Consumer Protection. "And they should always consult a physician or other health-care professional before using any product or treatment."
How to Report Suspicious Claims
The FTC and FDA encourage people to report suspicious health claims. Since January 2000, the FDA has checked out more than 3,000 tips submitted by consumers about suspicious online prescription Web sites, according to Tom McGinnis, R.Ph., the FDA's director of pharmacy affairs.
To file a complaint regarding a possible fraudulent, deceptive, or unfair business practice, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at www.ftc.gov.
If you find a Web site you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics over the Internet, use the complaint form at www.fda.gov/oc/buyonline/buyonlineform.htm.--L.B.
Be Suspicious
Promoters of fraudulent health-care products often use similar claims and practices to lure consumers into buying their goods. The FTC and FDA advise consumers to be suspicious of:
Claims that the product is "natural" or "non-toxic," suggesting it does not have side effects. "Natural" or "non-toxic" does not necessarily mean safe. Some "natural" supplements contain potent stimulants; others can result in negative interactions with medicines.
Testimonials from people who claim amazing results. Testimonials often are undocumented and are not a substitute for scientific proof.
Claims that a product is a "scientific breakthrough," "miraculous cure," "secret ingredient" or "ancient remedy."
Claims that the product is an effective cure for a wide range of ailments.
Claims that use impressive-sounding medical terms.
Claims that the product is available from only one source, and payment is required in advance.
Claims of a "money-back" guarantee.
Web sites that fail to list the company's name, physical address, phone number or other contact information.
--L.B.
For More Information…
For tips on buying health-care products on the Internet, check out:
FTC's Virtual Health Treatments [Note (8-6-2003): Now called Operation Cure.All]
FDA's Buying Medicines and Medical Products Online
For safety and other information on dietary supplements, see:www.cfsan.fda.gov/~dms/supplmnt.html
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FDA/Office of Public Affairs
Adhesion Related Disorder, ARD, Capps, Abdominal Pain, Adhesions, adhesion-related disorders, complex abdominopelvic and pain syndrome, chronic pelvic pain, hysterectomy. Patient oriented database of information regarding all aspects of internal scar tissue, adhesions.
Tuesday, April 29, 2008
Adhesions Headlines ARDvark Blog
Relistor For Opioid-Induced Constipation Approved By The FDA
Oral Prolonged Release Oxycodone / Naloxone Combination Reduces Opioid-induced Constipation In Severe Chronic Pain Patients, With No Loss Of Analgesia
Fewer General Surgeons In United States Today
Los Angeles Times Examines 'Exodus' Of Specialists From Southern California Emergency Departments
Hanys Issues "Report Card" On Hospital Report Cards
Women & Depression
Clinical Trial Results Show Proof-of-Concept For Use Of Coriolus Versicolor As Immunonutrition In HPV Patients With Cervical Lesions (LSIL)
BR Pharma Appoints Adele Davis As Head Of Clinical Trials
FDA Approves New Once-a-Month Dose Of Actonel For Postmenopausal Osteoporosis
New Advice On Treating GERD: Johns Hopkins Health Alerts Reports On The Latest Research
Brain-Gut Relationship Studied In Those Suffering With Stomach Pain Or Discomfort
FDA Approval Of Cimzia(R) For Crohn's Disease Represents Latest Milestone For Nektar's PEGylation Technology Platform
New Clinical Practice Guidelines On The Treatment Of Hirsutism
Oral Prolonged Release Oxycodone / Naloxone Combination Reduces Opioid-induced Constipation In Severe Chronic Pain Patients, With No Loss Of Analgesia
Fewer General Surgeons In United States Today
Los Angeles Times Examines 'Exodus' Of Specialists From Southern California Emergency Departments
Hanys Issues "Report Card" On Hospital Report Cards
Women & Depression
Clinical Trial Results Show Proof-of-Concept For Use Of Coriolus Versicolor As Immunonutrition In HPV Patients With Cervical Lesions (LSIL)
BR Pharma Appoints Adele Davis As Head Of Clinical Trials
FDA Approves New Once-a-Month Dose Of Actonel For Postmenopausal Osteoporosis
New Advice On Treating GERD: Johns Hopkins Health Alerts Reports On The Latest Research
Brain-Gut Relationship Studied In Those Suffering With Stomach Pain Or Discomfort
FDA Approval Of Cimzia(R) For Crohn's Disease Represents Latest Milestone For Nektar's PEGylation Technology Platform
New Clinical Practice Guidelines On The Treatment Of Hirsutism
Friday, April 04, 2008
Tuesday, March 25, 2008
Adhesions News ARDvark Blog
Surgeons Use Transplant Surgery To Remove Tumour
Written by Catharine Paddock, PhD
In a 15-hour operation, surgeons in the US used transplant surgery to remove and replace multiple abdominal organs so they could reach and cut out a tumour in a female patient who had a rare form of cancer...[read article]
Fertility Treatments And The Surprising Power Of The Pill
Free Drug Samples May Burden Patients' Pockets
FDA Classifies Medtronic's Physician Communication Related To Inflammatory Mass Formation From Intrathecal Drug Therapy
CHMP Upholds Negative Opinion For The EU Application For Cimzia(R) In The Treatment Of Crohn's Disease
Massachusetts Health Insurance Connector Approves 10% Premium Increases; State Finance Officer Says Program Is Underfunded
EndoGastric Solutions(TM) Announces Results Of EsophyX(TM) Multi-Center GERD Study
New Hope Available For The Millions Suffering From Chronic Fatigue Syndrome And Fibromyalgia
Time To Initiation Of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect On Symptom Improvement
Beyond The Abstract - Insight Into Urogynecologic Features Of Women With Interstitial Cystitis/Painful Bladder Syndrome
Can Psychotherapy Reverse Chronic Post-Traumatic Stress Disorder?
New York Times Examines 'Migration' Of Top Medical Students To Dermatology, Plastic Surgery
StatMedica Defends Medical Tourism
ASA Commemorates Doctors Day 2008
SUFU 2008 Winter Meeting - Genetic Factors In SUI/Pelvic Organ Prolapse
NovaBay Pharmaceuticals Commences Phase I Human Clinical Trial For The Prevention Of Catheter Associated Urinary Tract Infections
Written by Catharine Paddock, PhD
In a 15-hour operation, surgeons in the US used transplant surgery to remove and replace multiple abdominal organs so they could reach and cut out a tumour in a female patient who had a rare form of cancer...[read article]
Fertility Treatments And The Surprising Power Of The Pill
Free Drug Samples May Burden Patients' Pockets
FDA Classifies Medtronic's Physician Communication Related To Inflammatory Mass Formation From Intrathecal Drug Therapy
CHMP Upholds Negative Opinion For The EU Application For Cimzia(R) In The Treatment Of Crohn's Disease
Massachusetts Health Insurance Connector Approves 10% Premium Increases; State Finance Officer Says Program Is Underfunded
EndoGastric Solutions(TM) Announces Results Of EsophyX(TM) Multi-Center GERD Study
New Hope Available For The Millions Suffering From Chronic Fatigue Syndrome And Fibromyalgia
Time To Initiation Of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect On Symptom Improvement
Beyond The Abstract - Insight Into Urogynecologic Features Of Women With Interstitial Cystitis/Painful Bladder Syndrome
Can Psychotherapy Reverse Chronic Post-Traumatic Stress Disorder?
New York Times Examines 'Migration' Of Top Medical Students To Dermatology, Plastic Surgery
StatMedica Defends Medical Tourism
ASA Commemorates Doctors Day 2008
SUFU 2008 Winter Meeting - Genetic Factors In SUI/Pelvic Organ Prolapse
NovaBay Pharmaceuticals Commences Phase I Human Clinical Trial For The Prevention Of Catheter Associated Urinary Tract Infections
N.D. Supreme Court sends suit back to district court
Herald Staff Reporter
http://www.grandforksherald.com/articles/index.cfm?id=71390§ion=news
The North Dakota Supreme Court has overturned a district court’s decision in Grand Forks, allowing a woman’s malpractice suit — against Altru Hospital in Grand Forks and a surgeon, Dr. Jamil Tareen, who worked for Altru in 2004 — to proceed.
The case is based on surgery performed by Tareen on Denise White in February 2004 in the First Care Health Center in Park River, N.D. Tareen did a laparotomy, or a surgical incision to White’s abdomen, to remove “extensive pelvic adhesions.” White sued Tareen and Altru, his employer at the time, for negligence because Tareen’s medical license was restricted at the time, a fact she said was concealed from her before her surgery, according to the Court’s decision filed Thursday.
White also alleged Tareen’s surgery caused an injury he failed to diagnose or treat. White served Altru with a complaint in February 2006. After an exchange of counter-claims and other documents, Altru moved for the case to be dismissed based on a statute about a certain required affidavit that was not filed in time by White.
State District Judge Debbie Kleven granted Altru’s motion to dismiss and then denied White’s three motions for reconsideration, to overthrow the judgment against her and to amend her complaint.
The Supreme Court’s decision was based on a complicated analysis of what state law and precedent applies in determining a statute of limitations on such lawsuits, and what that means for someone appealing a lower court’s decision.
All five justices agreed Kleven’s court had “abused its discretion by denying” in December 2006 White’s appeals of the dismissal. The Supreme Court reversed Kleven’s decision and sent the case back to district court for consideration.
http://www.grandforksherald.com/articles/index.cfm?id=71390§ion=news
The North Dakota Supreme Court has overturned a district court’s decision in Grand Forks, allowing a woman’s malpractice suit — against Altru Hospital in Grand Forks and a surgeon, Dr. Jamil Tareen, who worked for Altru in 2004 — to proceed.
The case is based on surgery performed by Tareen on Denise White in February 2004 in the First Care Health Center in Park River, N.D. Tareen did a laparotomy, or a surgical incision to White’s abdomen, to remove “extensive pelvic adhesions.” White sued Tareen and Altru, his employer at the time, for negligence because Tareen’s medical license was restricted at the time, a fact she said was concealed from her before her surgery, according to the Court’s decision filed Thursday.
White also alleged Tareen’s surgery caused an injury he failed to diagnose or treat. White served Altru with a complaint in February 2006. After an exchange of counter-claims and other documents, Altru moved for the case to be dismissed based on a statute about a certain required affidavit that was not filed in time by White.
State District Judge Debbie Kleven granted Altru’s motion to dismiss and then denied White’s three motions for reconsideration, to overthrow the judgment against her and to amend her complaint.
The Supreme Court’s decision was based on a complicated analysis of what state law and precedent applies in determining a statute of limitations on such lawsuits, and what that means for someone appealing a lower court’s decision.
All five justices agreed Kleven’s court had “abused its discretion by denying” in December 2006 White’s appeals of the dismissal. The Supreme Court reversed Kleven’s decision and sent the case back to district court for consideration.
Monday, March 10, 2008
Adhesions Medical Headlines ARDvark Blog
Drugs In US Drinking Water
Written by Catharine Paddock
A five month investigation by the Associated Press has discovered that small quantities of drugs, including antibiotics, sex hormones, and anti-seizure compounds, have been found in public drinking water supplied to over 40 million Americans across the US...[read article]
Combo MRI/PET Scanner
Colorectal Cancer Gene Identified By Case Western Reserve University Researchers
Survey Of Hospital Execs Reveals Stark Differences Among Health Insurance Companies
Study Finds IONSYS™, A New Needle-Free System For Management Of Acute Postoperative Pain, Requires Less Staff Compared To IV PCA Treatment
Fellowship Supports Super Bug Crackdown
Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab
New Treatment Strategy For Crohn's Disease Shows Promise
Multicenter Trial On Minimally Invasive Fibroid Treatment
Bloody Diarrhea Can Indicate Ischemic Colitis
New Colorectal Cancer Screening Guidelines Focus On Prevention
Flat Colon Lesions Identified And Removed Using Colonoscopy
Statement On BBC Newsnight Report On Gaviscon, British Generic Manufacturers Association
Federal Court Invalidates Bayer's Patent On Yasmin Birth Control Pill
Massive Las Vegas Hepatitis C Scare Causes Public Health Crisis - Edward M. Bernstein & Associates Files Lawsuits
Los Angeles Times Examines Product Liability Lawsuits, Potential For Court To Shield Drug Makers
MRSA Is A Slow Moving Hurricane That Cannot Be Averted Says Infection Expert
Potential For New Antibiotics From Synthetic Peptoids
SUFU 2008 Winter Meeting Pelvic Organ Neurophysiology: Implications For Chronic Pelvic Pain And The Overlap Of Chronic Pelvic Pain
Followup Of Patients With Interstitial Cystitis Responsive To Treatment With Intravesical Bacillus Calmette Guerin Or Placebo
Written by Catharine Paddock
A five month investigation by the Associated Press has discovered that small quantities of drugs, including antibiotics, sex hormones, and anti-seizure compounds, have been found in public drinking water supplied to over 40 million Americans across the US...[read article]
Combo MRI/PET Scanner
Colorectal Cancer Gene Identified By Case Western Reserve University Researchers
Survey Of Hospital Execs Reveals Stark Differences Among Health Insurance Companies
Study Finds IONSYS™, A New Needle-Free System For Management Of Acute Postoperative Pain, Requires Less Staff Compared To IV PCA Treatment
Fellowship Supports Super Bug Crackdown
Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab
New Treatment Strategy For Crohn's Disease Shows Promise
Multicenter Trial On Minimally Invasive Fibroid Treatment
Bloody Diarrhea Can Indicate Ischemic Colitis
New Colorectal Cancer Screening Guidelines Focus On Prevention
Flat Colon Lesions Identified And Removed Using Colonoscopy
Statement On BBC Newsnight Report On Gaviscon, British Generic Manufacturers Association
Federal Court Invalidates Bayer's Patent On Yasmin Birth Control Pill
Massive Las Vegas Hepatitis C Scare Causes Public Health Crisis - Edward M. Bernstein & Associates Files Lawsuits
Los Angeles Times Examines Product Liability Lawsuits, Potential For Court To Shield Drug Makers
MRSA Is A Slow Moving Hurricane That Cannot Be Averted Says Infection Expert
Potential For New Antibiotics From Synthetic Peptoids
SUFU 2008 Winter Meeting Pelvic Organ Neurophysiology: Implications For Chronic Pelvic Pain And The Overlap Of Chronic Pelvic Pain
Followup Of Patients With Interstitial Cystitis Responsive To Treatment With Intravesical Bacillus Calmette Guerin Or Placebo
Unplanned Unmasking in Trial Cited in Warning Letter
In a SyntheMed clinical trial, an evaluation that should have been given by a blinded surgeon was performed by the same person responsible for the initial surgery and randomization of trial participants, according to a recent FDA warning letter.
Therefore, the surgeon was not blind to the randomization, the letter said. Although the name of the product is redacted, the letter noted that the study design requires a cardiac surgeon, masked to the randomization assignment, to assess the severity of adhesions at the investigational surgical site.
In its response, SyntheMed said the clinical investigator was reminded in 2005 that, according to the protocol, the surgeon performing the surgery could not conduct the assessment.
The response said in the future, monitors will be trained to ensure that when protocol violations occur, an appropriate corrective action plan will be used to prevent further violations. The FDA found the response inadequate as it does not include a written plan for reporting protocol deviations.
The company did not respond to a request for comment
Source: FDA
Therefore, the surgeon was not blind to the randomization, the letter said. Although the name of the product is redacted, the letter noted that the study design requires a cardiac surgeon, masked to the randomization assignment, to assess the severity of adhesions at the investigational surgical site.
In its response, SyntheMed said the clinical investigator was reminded in 2005 that, according to the protocol, the surgeon performing the surgery could not conduct the assessment.
The response said in the future, monitors will be trained to ensure that when protocol violations occur, an appropriate corrective action plan will be used to prevent further violations. The FDA found the response inadequate as it does not include a written plan for reporting protocol deviations.
The company did not respond to a request for comment
Source: FDA
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