Memorial Day 2008

We would like to pay tribute to those who went before us.
We remember these women, who died from complications related to their Adhesions Related Disorder, may they also represent the many who die without ever knowing what caused their deaths:

Edith Isabel Rodriguez

Ms Carol J Howland

Christina Buelteman

Marian Lewis

Cindy McAleer

Susan Stransky

Marjorie Lee Wantz

Tammy Wynette

Rochelle “Shellie” S. Sabowski

died July 13, 2003

(10 years of suffering with ARD) age 38

FDA Approves Entereg to Help Restore Bowel Function Following Surgery

FDA News
FOR IMMEDIATE RELEASEMay 20, 2008
Media Inquiries: Rita Chappelle, 301-827-6242Consumer Inquiries: 888-INFO-FDA
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."
FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.
In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.
Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.
The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.
The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).
FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.
Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Adolor Corporation, the manufacturer of Entereg

Is The Future Of Surgery Painless And Scarless?

Main Category: GastroIntestinal / GastroenterologyArticle Date: 21 May 2008 - 1:00 PDT

A sophisticated new surgical technology holds promise for future painless and scarless surgery with shorter recovery times than laparoscopic surgery. New research supporting the safety and efficacy of natural orifice translumenal endoscopic surgery (NOTESTM) and detailing the outcomes associated with new tools and robotic applications will be presented at Digestive Disease Week® 2008 (DDW®).

DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. "The research developments presented today are continuing to demonstrate the great potential of this exciting new surgical procedure," said Pankaj J. Pasricha, MD, FASGE, professor of medicine, gastroenterology and hepatology, Stanford University School of Medicine. "Surgical advances like NOTES may lead the way toward the adoption of even more minimally invasive techniques than laparoscopy and allow patients to return to their home, family and work more quickly."
NOTES is performed by passing an endoscope through a natural orifice then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars.

A Prospective Randomized Controlled Trial of NOTES versus Laparoscopic Distal Pancreatectomy, Preliminary Results (Abstract #881) Investigators have conducted the largest and most rigorously controlled study of natural orifice surgery to date. The study showed that while NOTESTM is more time-consuming than traditional (laparoscopic) surgery, it is equally successful. The study also demonstrated that complex surgery with a high rate of complications could be performed via the mouth using a flexible endoscope. "NOTES is an area of promise in active development," said Field Willingham, MD, MPH, senior fellow in the gastrointestinal unit at Massachusetts General Hospital. "The opportunities with NOTES are significant and should some day provide patients with a viable scarless and painless option for certain medical procedures." Previous NOTES research has involved small sample sizes and no control groups. This prospective, randomized controlled trial compared the efficacy of endoscopic transgastric distal pancreatectomy (ETDP) to laproscopic distal pancreatectomy (LDP). Investigators randomized twenty-eight 45kg swine to EDTP or LDP and then compared the results based on an extensive post-operative analysis. The procedure time for EDTP was significantly greater versus LDP (1:52 versus 0:32 hour), but investigators found no clinical or survival difference between the NOTES and laparoscopic approaches. Dr. Willingham noted that the tools used to dissect or retract during NOTES procedures may pose some limitations. "It can be challenging to perform complex procedures such as holding traction while simultaneously dissecting tissue through a single NOTES endoscope." However, this study does demonstrate the non-inferiority of NOTES in solid organ resection compared to standard laparoscopic surgery.
Successful Diagnostic and Therapeutic Intrauterine Fetal Interventions by NOTES (Abstract #871) Investigators using NOTESTM have found for the first time that it can look at the entire uterus and reach areas that had not previously been accessible. The findings are important because the morbidity and mortality of fetal surgery is substantial. If the fetus requires lifesaving surgery, the only way to operate previously was through traditional laparoscopy or laparotomy. But this method is limiting because the uterus and the fetus can only be accessed from the front; unless a doctor is aiming to intervene right beneath the abdominal wall, it would be difficult to access the desired organ. However, using flexible endoscopy, doctors can reach almost any part of the uterus, regardless of the direction the fetus is facing. Furthermore, the procedure could be particularly helpful since it provides a minimally invasive approach to performing fetal surgery. Researchers performed transgastric peritonoscopy on one ewe and transvaginal peritonoscopy on another following standard needle-knife entry into the abdominal cavity. Access to the uterus was assessed with both a forward-viewing endoscope and a linear-array echoendoscope. Visibility of the fetal areas via endoscopic ultrasound (EUS) was directly compared to transabdominal ultrasound. EUS-guided, transuterine injection of saline into the fetal cardiac ventricle was attempted in both sheep using a 22-gauge fine needle aspiration needle. Investigators found that access to and complete visualization of the uterus were successful with both endoscopes using an anterior, posterior and lateral approach once inside the abdominal cavity. Also, visualization of the fetal parts by EUS was impressive and superior to transabdominal ultrasound. "Our findings suggest that NOTES may provide an avenue through which one can ultimately stage even more complicated operations in pregnant women and the fetus," said Samuel A. Giday, MD, assistant professor of medicine at Johns Hopkins University School of Medicine division of gastroenterology and hepatology. Randomized Multicenter Controlled Study of Endoscopic and Surgical Closure of A Gastric NOTES Access
Perforation in a Porcine Model (Abstract #876) Researchers studying endoscopically sutured closure of a gastric access perforation using a T-tag tissue apposition system (TAS) compared to conventional surgical closure found that gastric NOTESTM access perforations can be safely and reliably closed using TAS. TAS is designed to suture via flexible endoscopes. It places a tilt T-tag attached to a thread into tissue using a small diameter flexible needle. Two or more threads can then be locked together using a thread locking device. All the components can be passed through a conventional (2.8 mm) accessory channel of a flexible gastroscope without requiring withdrawal of the endoscope. Unlike other suturing devices, it does not require loading onto the endoscope before use, it is much smaller in diameter, and it does not interfere with endoscope flexibility or function. The needle can be placed under direct vision with great accuracy and is intuitively easy to use. In a randomized, multi-center study of 30 pigs, investigators measured procedure time, recovery time and weight gain at days seven and 14. The study found that closure time using the endoscopic NOTES technique was significantly longer than with open surgery. However, researchers found that at necropsy on day 14, there were significantly more intra-abdominal adhesions (internal scarring sticking internal organs together) in the surgical group, mainly between the stomach, liver and abdominal wall. Concerns about efficacy and consequent safety of closure, especially of the stomach approach, are important if the potential benefits of a NOTES approach are to be realized. If the method can be as safe as a surgical closure and reduce adhesion formation then this will encourage further research in this field. Adhesions can cause abdominal pain and obstruction, very occasionally requiring surgery. Transgastric surgery as a NOTES access approach is in general more attractive than transvaginal or transrectal approaches, provided closure can be shown to be safe and effective. Recovery time following the procedure was the same in both groups, and there was no difference in post-operative weight gain between the groups. Also, a gastric NOTES access perforation can be safely closed endoscopically using TAS sutures and clips. Lastly, researchers found that animals in the endoscopic group had significantly fewer lesions at autopsy, and recovered more quickly post-operatively, compared with open surgery. "Because the TAS system allows access to small and remote areas, and results in less scarring than open surgery closures, it may be the key to expanding the use of the NOTES procedure," said Paul Swain, MD, of the department of technology and medicine at the Imperial College of Science in London.
Robotics and NOTES: A Good Marriage or Just Hype? (Abstract #Sp535) Incisionless surgery using robotic technology, in which surgeons work exclusively through the mouth or other openings, showed excellent results in a recent study. The approach is important for three reasons: first, it allows patients to undergo procedures without pain and scarring; second, the procedure is performed on an outpatient basis; and third, the robotic technology enables doctors to perform procedures in ways they would not otherwise be able to do. Researchers used a small robotic device to perform more than 25 procedures in five animals - including abdominal exploration, bowel manipulation, cholecystectomy, and intracorporeal suturing, partial splenectomy and liver resection - without making cuts to the abdomen. The devices, which are the size of two lipstick tubes, have a central body, two working arms and a built-in light source. Researchers obtained standard transgastric access, and then passed a 22-millimeter overtube past the gastrotomy. They then inserted several miniature robots to perform the operations. Each procedure was accomplished with at least two robots and endoscopic assistance. Researchers found that visualization of the operative field was superior to endoscopic manipulation alone because it offered more opportunities for use. "Currently there are a number of endoscopic tools for taking out polyps" said Dmitry Oleynikov, MD, director of minimally invasive surgery at the University of Nebraska Medical Center. "But this technology can do much more, and it can do it more efficiently." For example, the robotic device could be used to remove portions of the colon that had cancer, it could remove the spleen, or it could repair a hernia. Dr. Oleynikov said that while the device showed promising results in this study, it has limitations. For example, while its small size allows it to reach areas that other devices cannot, the device is not large enough to move around larger organs, so more research will have to be done to make it more robust, especially for human use. He said it is possible that with successful FDA trials, the technology could be available for human use any time from 18 months to three years from today.

Digestive Disease Week® 2008 (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2008 in San Diego, Calif. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. Massachusetts General Hospital

http://www.medicalnewstoday.com/articles/108095.php

Medicolegal consequences of postoperative intra-abdominal adhesions

Harold Ellis CBE FRCS
Human Sciences Research, King's College London, Hodgkin Building, Guy's Hospital Campus, London SE1 1UL, UK





SUMMARY
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Postoperative adhesions are an almost invariable consequence of abdominal and pelvic surgery. Their most important morbidity is small-bowel obstruction, but other sequelae include female infertility and dyspareunia and increased risk of visceral injury at subsequent laparotomy or laparoscopy. Whether chronic abdominal pain is truly a consequence of adhesions is debatable, although it is likely to be accepted as an entity by both patients and their legal advisors. Of 14 successful claims dealt with by a British medical defence organization, 5 were for perforations after laparoscopic division of adhesions, 2 for adhesions after laparoscopic surgery, 1 for infertility as a result of adhesions and 6 for delayed diagnosis of obstruction. General practitioners, surgeons and gynaecologists need to be aware of the increasing burden of medicolegal claims arising from these complications.

INTRODUCTION
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Complications resulting from postoperative intra-abdominal adhesions have been the subject of increasing medicolegal litigation, but hard facts are not easily obtained. Repeated letters to the National Health Service Litigation Authority, which is the body responsible for all NHS hospital litigation since January 1990, have not been acknowledged. However, I have been greatly helped by Dr Stephen Green, of the Medical Defence Union, and by Dr Jane Cowan, of the Medical Protection Society, who have provided details of patients' claims and complaints that have reached these organizations in recent years. Although this information is confined to claims made against general practitioners in the public and private sectors and against surgeons and gynaecologists in private practice, it does provide a picture of litigation resulting from the consequences of abdominal adhesions over the past decade.
Adhesions are almost invariable after abdominal surgery. In our review of 210 laparotomies on patients who had undergone one or more previous abdominal operations, 94% had adhesions; the exceptions were patients who had undergone lower segment caesarean section or elective appendicectomy1. Today, abdominal surgery is extremely common in the western world. In 2645 necropsies, Robert Beart, at the University of Southern California in Los Angeles, found evidence of previous abdominal operations, in 32%—a figure that rose to 44% in those over sixty years of age (Personal communication). We can infer, therefore, that nearly one-third of the adult population have intra-abdominal adhesions. The great majority of these are entirely symptomless; however, even a low morbidity in such a large group of the population will result in a considerable surgical workload.

FREQUENCY OF INTESTINAL OBSTRUCTION
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Far and away the most important morbidity from adhesions is the development of acute intestinal obstruction. Indeed, adhesions are responsible for between 60% and 70% of all cases of small-bowel obstruction in the western world2. In our own study of 2708 laparotomies, 1% of the patients required surgery for adhesive obstruction within a year of surgery, half of these within the first four weeks. There is also a long-term risk of this complication; of 80 patients admitted with adhesive obstruction, 17 (21%) had had their initial laparotomy ten years or more previously1.
We have reported3 a study of the entire population of Scotland, some five million, based on figures obtained from the Scottish NHS medical record linkage database in Edinburgh. Patients were identified who had undergone open abdominal or pelvic surgery in 1986 and who had no record of such surgery in the preceding five years. These patients were followed up for ten years. Of the 29 790 patients studied, 5.7% were readmitted with complications directly consequent on adhesions, of which 3.8% required surgery. Of these readmissions, 22.1% occurred in the first year after the initial surgery, but the remainder of readmissions continued steadily over the ten-year period.

MEDICOLEGAL CONSEQUENCES
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES The following, in order of frequency, are the topics that, in recent years have led to complaints and claims against medical practitioners: failure of diagnosis, or delay in diagnosis; bowel damage at adhesiolysis (at laparoscopy more than at laparotomy); chronic abdominal or pelvic pain; infertility or risk of infertility; starch granuloma consequent upon use of starch-powdered gloves; and failure to take precautions to prevent adhesion formation.
Between 1989 and 1999, the Medical Protection Society dealt with 13 claims in which adhesions had been implicated. 9 of these involved general practitioners; in all of them the complaint was of delayed or failed diagnosis. 3 claims were made against gynaecologists—one for failure to diagnose and two for bowel damage at adhesiolysis (one at surgery, the other at laparoscopy). The final case involving a surgeon was, again, bowel damage at operative division of adhesions.
The Medical Defence Union was able to supply more comprehensive information. This organization has a membership of some 22 000 general practitioners, 500 gynaecologists and 720 general/vascular surgeons. Over the six years 1994-1999 it received 77 claims pertaining to abdominal adhesions, as follows: failure to diagnose or delay in diagnosis, 21; visceral injury at laparoscopy, 12; visceral injury at laparotomy, 10; pain, dyspareunia, infertility, 7; failure to use ‘Sepracoat’, 1; failure to warn of risk, 1; and various (including death during adhesiolysis, miscarriage following), 25.
Over an eleven-year period, 14 cases were settled out of court by the Medical Defence Union, the range being £7960-124 261, average per case £50 765. These 14 cases comprised:
Perforations after laparoscopic division of adhesions, 5
Adhesions after laparoscopic surgery, 2
Infertility as a result of adhesions, 1
Delayed diagnosis of obstruction, 6

STARCH GRANULOMAS
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Cases of intra-abdominal starch granulomas, often presenting as postoperative intestinal obstruction, were extensively reported in the 1960s4, resulting from the starch on surgical gloves. Since 1971 the US Food and Drug Administration have required warnings of the starch hazard on glove packets, and since 1983 powder-free gloves have been commercially available. Because of the almost universal use of such gloves in the UK, there seem to have been no cases of litigation on this count. There were three court cases concerning starch granulomas in the USA in 1969, 1970 and 1974.

WHAT ARE THE LESSONS TO BE LEARNED?
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES Surgeons, gynaecologists and general practitioners must be alert to the possibility that obstructive symptoms early and late after abdominal surgery are likely to be caused by adhesions. Delayed diagnosis can result in gangrene and even perforation of the strangulated bowel, with substantial morbidity and mortality.
The question of chronic abdominal pain as a result of adhesions is a difficult one. The clinical features of acute and of recurrent subacute intestinal obstruction are well known. Whether ‘grumbling’ abdominal pain can result directly from adhesions is debatable. Most surgeons in the UK doubt the organic basis of this syndrome, which is particularly seen after gynaecological surgery. Clearly, millions of people with postoperative adhesions remain pain-free for life. However, the judiciary are more likely to believe post hoc, propter hoc and to side with the complainant. It is easier to understand how a tethered ovary in the pelvis might result in dyspareunia.
The risk of visceral injury, especially of gut perforation, when adhesions are divided at reoperation has lately been quantified in a retrospective study. Workers from the University Hospital at Nijmegen5 showed that inadvertent enterotomy occurred in no fewer than 52 (19%) of 270 patients undergoing relaparotomy, with 7 deaths (13%) compared with 16 (7%) in the remaining 218 patients. Independent risk factors for injury to the bowel were obesity, age and three or more previous laparotomies. A similar study of incidence and risk factors for laparoscopic adhesiolysis would be welcome. Clearly, patients need to be warned of this danger preoperatively and surgeons need to be alert to it, ready for immediate repair of any injury. For injuries sustained at laparoscopy, this will mean conversion to an open operation.
Although adhesion formation is almost invariable after laparotomy, surgeons should take all reasonable precautions to limit its extent and, in particular, try to prevent adhesions to small intestine with their risk of bowel obstruction. Starch-powdered gloves must be avoided. Peritoneal defects and the pelvic floor should be left open since these rapidly reperitonealize. Anastomoses should be covered by omentum, which should be drawn down under the inner aspect of the laparotomy incision. There is obvious need for the development of effective and safe antiadhesion agents.

REFERENCES
TOPSUMMARYINTRODUCTIONFREQUENCY OF INTESTINAL...MEDICOLEGAL CONSEQUENCESSTARCH GRANULOMASWHAT ARE THE LESSONS...REFERENCES

Menzies D, Ellis H. Intestinal obstruction from adhesions; how big is the problem? Ann R Coll Surg Engl1990; 72:60 -3[Medline]

Ellis H. The magnitude of adhesion related problems. Ann Chir Gynaecol 1998;87:9 -11[Medline]

Ellis H, Morgan BJ, Thompson JN, et al. Adhesion related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet1999; 353:1476 -80[Medline]

Ellis H. Pathological changes produced by surgical dusting powders. Ann R Coll Surg Engl1994; 76:5 -8[Medline]

Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M, et al. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg2000; 87:467 -71[Medline]

Agencies Team Up in War Against Internet Health Fraud

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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