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The American Association for the Study of Liver Diseases November 2011 Annual Meeting
Today's AASLD Updates
In The News
Psychiatric Complications of Hepatitis C Treatment - Part 1
TexasLiverdotcom
Of all the concerns regarding chronic hepatitis C and the treatment associated with it, getting through the side effects of the treatment is the number one concern I hear every day of the week. Of all the possible side effects, the psychiatric side effects, namely depression, is such a concern, that patients with HCV stay away and avoid this necessary treatment. This is a dangerous move. Unfortunately, I have seen patients putting off treatment so long that when they do present themselves, they have developed cirrhosis and complications such as liver cancer.
In the literature and throughout the Internet, concerns over suicide fill the web, adding to the anxiety. In my 20+ years of treating thousands of HCV patients, I have never had a patient commit suicide. Central to this discussion is the requirement of having expert psychiatric support for all of your hepatitis C patients. Simply because you do not have depression today will not insure that while on therapy, depressive features will not develop. This won’t be the end of the world, simply a sign that additional care and support is required. Despite some differences in opinion from those less familiar with HCV therapy, apart history of depression is not an absolute contraindications to HCV therapy.
In my practice, Liver Specialists of Texas, I am very fortunate to have Dr Jennifer Pate on our team to manage all of the psychiatric side effects that develop. In this video, she review in great detail the issues that patients may face. There is no other resource like this on the web. The video is in two parts, the second part will be launched later this week.
This video should be a resource for patients considering HCV therapy, as well as those already on treatment. Family members and caregivers should also be familiar with its content. Of course, this video is a tool, and does not replace seeing a mental health professional. Patients of mine will see Dr Pate as needed. For those elsewhere, speak with your treating physician, as well as your family physician, and investigate prior to starting treatment what resources are available to you in the event psychiatric side effects develop.
In Case You Missed It/Boceprevir
November 7, 2011
Boceprevir-based regimens bested standard therapy in prediction model
Boceprevir-based regimens, compared with a standard therapy regimen, were more cost-effective, significantly reduced the lifetime incidence for liver complications and were associated with an increased quality of life among treatment-naive patients with chronic hepatitis C genotype-1 infection, according to results of a prediction model.
As previously reported in Infectious Disease News, results from the SPRINT-2 trial indicated that fixed-duration therapy of boceprevir (Victrelis, Schering) plus peginterferon alfa-2b and ribavirin, as well as response-guided therapy, significantly increased sustained virologic response rates vs. treatment with standard peginterferon alfa-2b and ribavirin therapy alone among previously untreated adults with chronic HCV genotype-1.
plus response-guided therapy regimen and a boceprevir plus peginterferon alfa-2b and ribavirin regimen vs. the standard therapy regimen among adults included in the SPRINT-2 trial.
A 41% and 46% predicted decrease in the lifetime incidence for liver complications was observed among adults randomly assigned to a boceprevir plus response-guided therapy regimen and a boceprevir plus peginterferon alfa-2b and ribavirin regimen, respectively.
In addition, the researchers predicted an incremental cost-effectiveness ratio of $24,017 for a boceprevir plus response-guided therapy regimen and $39,733 for a boceprevir plus peginterferon alfa-2b and ribavirin regimen.
Canada NewsWire
MONTREAL, Nov. 7, 2011
Data Presented at the American Association for the Study of Liver Diseases
2011 Annual Meeting
MONTREAL, Nov. 7, 2011 /CNW/ - Today Merck announced results of an interim analysis from the PROVIDE study, an open-label study examining the efficacy of VICTRELIS™ (boceprevir), the company's first-in-class, oral hepatitis C virus (HCV) protease inhibitor, in combination with peginterferon alpha and ribavirin (P/R) in adult patients with chronic HCV genotype 1 who had a null response to prior P/R therapy. These patients are significantly less likely to respond to subsequent treatments. In this interim analysis, 38 per cent (16/42) of prior null responders achieved a sustained virologic response (SVR), meaning they were able to clear the virus from the body, when treated with boceprevir in combination with P/R. These results were presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
"The null responders are the toughest patient group to treat and until now, there was not much optimism that they could ever clear the hepatitis C virus," says Eric Yoshida, M.D., study investigator and Professor of Medicine at the University of British Columbia. "The PROVIDE study definitely demonstrates that boceprevir with peginterferon and ribavirin can provide these patients with hope for the future."
About the PROVIDE Study
The PROVIDE study is an ongoing, open-label, single-arm, multicenter rollover study for patients who participated in the P/R control arms of the Phase II and Phase III studies for boceprevir and failed to achieve SVR. Of these, 48 patients from the two pivotal Phase III trials for boceprevir (HCV SPRINT-2 and HCV RESPOND-2) met the traditional definition for null response (less than a 2 log HCV-RNA decline at treatment week 12). These patients were retreated with a 4-week lead-in of peginterferon alpha-2b (1.5 mcg/kg/week) and ribavirin (600-1,400 mg/day), followed by the addition of boceprevir (800 mg three times a day) for 44 weeks. Three of these patients discontinued treatment during the 4-week P/R lead-in phase prior to receiving boceprevir, two patients are currently on treatment and one patient is currently in the follow-up phase. Among patients completing treatment and follow-up, 38 per cent (16/42) achieved SVR and 16 per cent (3/19) relapsed.
Hepatitis C in Canada
An estimated 250,000 individuals in Canada are infected with HCV and there are 3,200 to 5,000 newly infected individuals each year1. HCV damages the liver and may lead to serious complications, including death, when left untreated2. It is the leading cause of liver transplants in Canada3.
There is a stigma linked with hepatitis C infection because of its association with injection drug use4, which poses a major barrier to detection and treatment. As a result, those who are undiagnosed may continue to unknowingly spread the virus to others5.
Boceprevir in Canada
Boceprevir (VICTRELIS™) was approved for use in Canada in July of this year for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alpha and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous peginterferon and ribavirin therapy6.
Common side effects of combination treatment include fatigue, anemia, nausea, headache and bad taste (dysgeusia)7.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with boceprevir extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis C treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships.
Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
™ Trademark of Schering Corporation, a subsidiary of Merck & Co., Inc. Used under license.
Thousands Of Lives Each Year Could Be Saved By Birth Cohort Screening For Hepatitis C
About 1.5 percent of the nation's population is infected with hepatitis C (HCV), a virus that can cause inflammation and permanent liver damage. The infection is most prevalent among people born from 1945 through 1965, and approximately 50 to 75 percent of those with HCV are unaware that they are infected. This is a problem because HCV progresses slowly, and the risk of serious complications increases as time passes. In 2005, HCV resulted in up to 13,000 deaths. Experts say that without changes to current case identification and treatment, deaths from HCV are projected to increase to 35,000 a year by 2030.
Currently, the Centers for Disease Control and Prevention (CDC) recommends antibody screening only of individuals with health or lifestyle indicators suggesting potential infection. These indicators include a history of injecting drugs, having a blood transfusion before 1992, or being a chronic hemodialysis patient. Low case identification may result from the difficulty of implementing risk-based screening given the limited time of primary care visits and unease in discussing behavioral risks.
Researchers sought to determine if proactively screening the birth cohort of people born from 1945 through 1965 for HCV would be cost effective in the primary care setting. They developed a computer model to analyze the cost effectiveness of four scenarios: 1) no screening or treatment; 2) risk-based screening and standard treatment (pegylated interferon and ribavirin); 3) birth cohort screening with standard treatment; 4) birth cohort screening with standard treatment for patients identified with hepatitis C genotype 2 or 3, and standard treatment plus a direct acting antiviral drug (DAA) for patients identified with genotype 1 disease (the most prevalent genotype in the U.S.).
The researchers found that compared to the current strategy of risk-based screening, birth cohort screening followed by standard treatment reduced deaths by 82,300 at a cost of $15,700 per quality adjusted life-year (QALY) gained. Incorporating DAA treatment to standard therapy when indicated would prevent approximately 121,000 deaths compared to risk-based screening at a cost of $35,000 per QALY gained.
"The important things to remember about birth cohort screening are that, first, the strategy would identify over 800,000 people with hepatitis C if it were fully implemented, and second, the strategy is at least as cost-effective as many routinely administered preventive practices such as breast cancer screening or colorectal screening," said David Rein, PhD, Principal Research Scientist, Public Health Research Department, NORC at the University of Chicago, and lead author of the study.
Twelve Weeks Interferon-Free PSI-7977 Regimen Cures 100 Percent Hep C Genotype 2/3
A twelve-week course of Pharmasset’s once-daily experimental nucleotide analog PSI-7977, combined with ribavirin, cured 10 of 10 people living with genotype 2/3 hepatitis C virus (HCV) who used the regimen—without pegylated interferon—in a Phase II clinical trial. The highly encouraging results were reported Sunday, November 6, at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
Compared with the three other groups included in the study, which involved taking PSI-7977 plus ribavirin with either four, eight or 12 weeks of pegylated interferon, significant improvements in safety and tolerability were also documented among those using PSI-7977 plus ribavirin alone, according to Edward Gane, MD, of the Auckland City Hospital in Auckland, New Zealand, and his ELECTRON study colleagues.
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New drugs effectively wipe out hepatitis C
Roxanne Smith doesn't know how, when or where she contracted hepatitis C.
She just knows she now has a good chance of beating it.
"My hope is to kill the virus," the Lincoln woman said. "Kill it dead."
Although some hepatitis C patients in the past have used medications to permanently wipe the virus from their systems, two drugs approved this year by the Food and Drug Administration appear to do the job more successfully.
The drugs are extremely expensive — $25,000 to $50,000 for a course of treatment designed to eliminate the virus, in addition to about $30,000 for other drugs that are part of the treatment. They also have harsh side effects.
Nevertheless, doctors and patients have greeted the new drugs as potent weapons in the fight against a disease that can scar and ruin the liver.
"I think this is one of the biggest advances in medicine this year," said Dr. Marvin Bittner, a Creighton University and VA Medical Center infectious disease expert.
"It's a remarkable accomplishment, by all means," said Dr. Antonio Sanchez, a transplant hepatologist, or liver expert, at the University of Iowa Hospitals and Clinics. Sanchez said hepatitis C patients make up 40 percent to 50 percent of patients needing liver transplants.
The Food and Drug Administration approved both drugs in May.
Dr. Mark Mailliard, a University of Nebraska Medical Center hepatitis expert, said the old treatment strategy eradicated hepatitis C in about 40 percent of patients. The new strategy, based on clinical trials, appears to wipe it out in about 70 percent. Some patients with significant liver scarring or other medical problems aren't candidates for the new therapy.
Hepatitis C is a contagious liver disease that is generally spread by sharing needles or other equipment to inject drugs or medication. The federal Centers for Disease Control and Prevention says that before 1992, when widespread blood-supply screening began, hepatitis C also was commonly spread through blood transfusions.
The CDC estimates that 3.2 million Americans are chronically infected with hepatitis C. Some doctors believe it's much higher because, they say, the prison population and homeless people are undercounted and have high rates of the disease.
More than 800 new cases of the disease have been reported this year in Nebraska and more than 2,000 have been reported in Iowa, state health officials said. In most instances, the virus simmers in the system for years before seriously damaging the liver.
Many viruses, such as HIV and herpes, can only be suppressed and not cured, Mailliard said.
But hepatitis C can be wiped out entirely in some patients.
The new medications, which are in pill form, go by the brand names Incivek and Victrelis and also are known as telaprevir and boceprevir, respectively.
Until the new drugs came along, hepatitis C patients generally took a combination of interferon injections and a medication called ribavirin. That regimen, taken for many weeks, also had an array of side effects, including fatigue, irritability and rashes.
A patient receiving the newest regimen still takes those medications for weeks, plus either Incivek or Victrelis through a portion of that period.
"You take the tough treatment and you make it even tougher," Bittner said. "You take an expensive treatment and you make it even more expensive."
Mailliard, Bittner and others said the new therapy is generally worth the price and pain. Mailliard said he has prescribed the new drugs for about 90 patients and has seen excellent results based on blood tests during the course of therapy. The treatment may last a year, and patients must wait six months before testing reveals whether it has cured them. So it's too early to declare any of those patients cured.
Side effects of the new treatment regimen may include serious rashes, diarrhea, nausea and mouth sores, among others. Mailliard said that with the old regimen, five to 10 percent of patients weren't able to tolerate the effects. It appears that 15 to 20 percent won't be able to tolerate the new therapy, he said.
Most insurance covers the regimen, and both pharmaceutical companies that make the drugs provide financial assistance for those who need it. A spokeswoman for Vertex, which makes Incivek, said the company will provide the medication for free to an uninsured patient whose income is less than $100,000.
Medicaid in Iowa will cover both Incivek and Victrelis, while Nebraska Medicaid so far has asked doctors to use only Victrelis because it's less expensive. Mailliard said this is unfortunate because Incivek may be slightly more effective and the regimen is less complicated and thus easier for patients to understand and use.
Mark Crane, a 53-year-old Omahan, is undergoing the hepatitis C treatment through the VA Medical Center. The VA is covering it and so far, Incivek, interferon and ribavirin appear to be knocking the virus out of his system. Crane is about four months into his treatment.
He said his side effects have included fatigue, fever, nausea and insomnia, but he is pleased with the result.
"It seems to work," Crane said. "It's really good."
Roxanne Smith, whose insurance covers most of the cost, has continued to work as a flight attendant through the almost yearlong treatment period.
"I don't want the fear of it becoming a devastating treatment to keep people from trying," Smith, 57, said.
Smith has completed her Incivek therapy but is still taking interferon and ribavirin to complete the treatment. She had a bit of nausea and some sores in her mouth. She briefly had some weariness and shortness of breath.
"I think I'm one of the lucky ones," she said. "I know people that are in treatment right now that are having real side effects."
She sees this as her chance to push the virus from her system once and for all.
"I'm fighting it," she said of hepatitis C. "It's had me long enough."
Contact the writer: 402-444-1123, rick.ruggles@owh.com
Pharmaceuticals/Market Snapshots
Pharmasset Rises After Hepatitis-C Drug Shows 100% Cure Rate in Trial
All 40 patients who received Pharmasset’s experimental PSI- 7977 drug were responsive after 12 weeks, the company said yesterday the annual meeting of the American Association for the Study of Liver Diseases in San Francisco. About half the patients had been followed up to 24 works, and they were all cured. There were no significant adverse events.
“Although patient numbers are small, we believe the results are extremely impressive,” wrote Brian Abrahams of Wells Fargo Securities in a note to investors today.
The drug was tested in combination with ribavirin, a medication currently used in treating the disease, in patients with hepatitis C genotypes 2 and 3. Genotype 1 is most common and hardest to treat.
There were four groups in the study: Those who were treated with no interferon and those who received four weeks, eight weeks and 12 weeks of it, according to the data. The study was initiated to see the shortest duration of interferon, which is injected, required for a response.
On Nov. 1, Pharmasset announced it began a phase 3 clinical trial of the drug in combination with ribavirin, without interferon. That would be an all-oral regimen to treat hepatitis C.
Many if not most ‘attendees’ on Dendreon’s (DNDN) November 2, 2011 conference call were taken by surprise when Greg Schiffman, the company’s chief financial officer, mentioned that “[F]or the quarter … the company booked approximately $3 million of royalty revenue … related to intellectual property, licensed to Merck (MRK) and associated with its newly launched product Victrelis for the treatment of hepatitis C.”
My immediate response to this comment was ‘What is Victrelis, and what part will it play in Dendreon’s future?’ A little research revealed the following.
According to an FDA News Release on May 13, 2011,
[T]he U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
The drug, which is marketed by Whitehouse Station, N.J.-based Merck & Co., is a pill that is taken three times a day with food. It’s part of a class of drugs known as protease inhibitors, which work by binding to the virus and preventing it from multiplying. Merck is ramping up efforts to push its new hepatitis C treatment Victrelis to the fore, signing a global promotion deal with Roche (RHHBY.PK) which includes Europe, Asia and Latin America. The drug already has received a positive opinion from the European CHMP for treatment of chronic HCV genotype 1 infection. Say what you will about Big Pharma, when it comes to launching a new drug worldwide, no one does it better!
The US Centers for Disease Control and Prevention finds that in 2007 (the latest year, surprisingly, that data are available on the agency’s Web site), there were an estimated 17,000 new C virus infections in the US. Further, an estimated 3.2 million persons in this country are thought to have chronic hepatitis C virus infection. Unfortunately, most people are not even aware they are infected because they don’t look or feel sick, and there is no vaccine for the disease.
In addition to treating hepatitis C, Merck also recently announced that early results from a clinical trial show that Victrelis is more effective than the standard drug cocktail at treating patients who also have HIV. Final results of the study, which is designed to last 48 weeks, should be announced in 2012.
Inhiditex From Seeking Alpha
Four million Americans have hepatitis C. 3 million don't know they have it. Don't let Hepatitis C stay hidden.
- New York City subway ad
There are ads all over New York City exposing the hidden hepatitis C disease to the public. While a year ago most people had not even heard about hepatitis C, now it is warned about in all the major cities. Here are a series of photos of ads about this horrible disease.
People can have it for several years without knowing it because no symptoms show up in the beginning stages. However, advanced stages of the virus can cause a condition called cirrhosis, which is the permanent scarring of the liver. At that point, all kinds of symptoms turn up from the liver damage like nausea and extreme abdominal pain. As it gets worse, it can prove fatal or patients must get liver transplants.
Current Hepatitis C Treatments
About two dozen pharmaceutical companies are now pursuing drugs for hepatitis C, which an executive at Vertex Pharmaceuticals (VRTX) recently called “one of the largest pharmaceutical opportunities this decade.”
Research for a hepatitis C treatment hasn't been very extensive because it had not gotten mainstream yet, so it wasn't worth it for pharma companies to devote a lot of research to it. Now that the disease is at the forefront of the public's mind and more people have it, pharmas are devoting time to developing new drugs for it to make treatment less grueling on the patients. The pharmas that are in first will reap huge rewards. The virus infects roughly four million Americans, most of them baby boomers, and 170 million people worldwide.
Currently, the best treatment for hepatitis C is Pegylated Interferon + Ribavirin. This cures about 75% of patients with hepatitis C. The problem is with Pegylated Interferon. It is given by injection and there are many side effects like dry eyes, depression, nausea and thinning hair. Ribavirin is taken orally.
A New Hepatitis C Treatment?
Inhibitex (INHX) has now created a drug, INX-189, that so far looks like it can take the place of interferon. Inhibitex CEO Russell H. Plumb on the 3rd quarter earnings call on November 4th had this to say about Inhibitex' Phase II study of INX-189.
"In this study, 200 mg INX-189, dosed once-daily for seven days, continued to demonstrate potent and dose-dependent antiviral activity. Further, 200 mg INX-189 was generally well tolerated, and there were no serious adverse events or dose dependent adverse events observed." What Plumb is saying is that antiviral activity increases the bigger the dose taken of INX-189, and there are very minor side effects. This great report of INX-189 comes after only the first step of Phase II studies! Once Inhibitex experiments mixing INX-189 with other drugs like Ribavirin, and in various doses and different ways, the company can find the most effective use of the drug to stamp out hepatitis C for good. INX-189 is also taken orally, and not by painful injections.
Other Drugs In The Pipeline
Inhibitex is getting funding from Pfizer (PFE), its licensee and collaborator, which paid the company $1 million last quarter for completing milestones on the initiation of a Phase 1/ 2 clinical trial of a 4-antigen Staphylococcus aureus (S. aureus) vaccine (SA4Ag).
INHX is also getting ready to continue Phase 2b of its FV-101 drug for shingles, which it may do in 2012. The company plans to request guidance and work with the FDA on that later this month.
While it will take a couple more years to finish the trials of INX-189, Inhibitex is in great shape financially and is a possible takeover target. It has $53 million in cash and very little debt. With losses of only around $5-$6 million a quarter, INHX could last another three years before needing more funding, in which case it could be selling its drugs or be bought out by then. INHX is careful with its spending; R&D costs went up to $5.7 million from $4.7 million in Q3 2010, and general and administration costs were $0.9 million in the third quarter of 2011, which was the same amount as reported in the third quarter of 2010.
When INHX reported the positive results of INH-189 on November 4th, the stock more than doubled and gained about $400 million in market cap. While that sounds like a lot, INHX has further upside. During that same day, its competitor, Pharmasset (VRUS) lost about $600 million worth of market cap. The Pharmasset investors are very nervous. VRUS is currently starting its Phase 3 trial of its hepatitis C drug PSI-7977, which is very similar to Inhibitex' INX-189. Both drugs are orally taken and both take the place of interferon. VRUS has a current market cap of $5.2 billion. Upon successful completion of its Phase 2 trials of INX-189, it's likely that INHX will also have a market cap in the billions. Currently, it's only at $670 million.
Off The Cuff
How Not To Create A Prescription Drug Website
Given the increased scrutiny the FDA is applying toward websites devoted to individual prescription drugs, it may behoove the people who design these sites to include some basic info. Such as? Well, there are always tidbits about safety and efficacy. A helpful rule of thumb, for instance, is to ensure safety info is not minimized or absent. And using hyperbole to describe the drug is not a good idea.
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FYI
Physicians Worry About Misinformed Patients in Internet Age
November 4, 2011 — The Internet puts solid health information at a patient's fingertips, but 2 new studies suggest that too many of those fingertips stray into questionable territory.
In a survey from Wolters Kluwer Health, 78% of physicians said that lack of time is one of the most common challenges for physician-patient communication. The next biggest problem in this regard — cited by 53% of physicians — is misinformed patients.
The phone survey, conducted in August, included more than 300 US physicians, roughly split between primary care physicians and specialists.
The survey sheds more light on the increasingly larger role — for good and ill — that the Internet plays in healthcare. The Pew Research Center reports that 78% of adults use the Internet, and of these, 83% look up health information online.
However, the value of that information is debatable. While just over half (53%) of physicians in the Wolters Kluwer Health survey said that easier access by patients to medical knowledge has improved the exam-room experience, 1 in 5 said that this easier access "has been detrimental, leading to misinformation and incorrect self-diagnosis."
YouTube Videos on IBD Found Wanting
Similar misgivings emerged in a study presented by Cleveland Clinic Foundation researchers at the annual scientific meeting of the American College of Gastroenterology (ACG) that ended this week. The researchers analyzed the 100 most-viewed YouTube videos on inflammatory bowel disease (IBD) and rated their overall educational quality as poor.
"Clinicians and their patients need to be aware of misleading information posted by patients or particularly by pharmaceutical companies who often post videos to make it seem like they are coming from a patient when in actuality it is a company advertisement," said researcher Saurabh Mukewar, MD, in an ACG press release. "These sources are not transparent."
"The Internet and social media are not going away — YouTube is a powerful platform to deliver and receive healthcare information," said Dr. Mukewar, an internal medicine resident at the Cleveland Clinic. "But healthcare providers and professional societies need to provide more educational and efficient materials using this powerful tool to counteract misleading information."
Journalist
Robert Lowes
Robert Lowes is a journalist for Medscape Medical News. A former senior editor at Medical Economics magazine and contributor to numerous healthcare publications, Robert has covered medicine from almost every conceivable angle — public policy, managed care, education, ethics, medical malpractice, information technology, billing and collections, waiting-room design, and first-degree murder. His articles have won major awards such as first place in the annual journalism competition of the National Institute for Health Care Management, and several have been republished in books. Robert also is an anthologized poet. He can be contacted at rlowes@medscape.net.
Robert Lowes has disclosed no relevant financial relationships.
November 4, 2011
The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts distributed by Sunrise Commodities, based in Englewood Cliffs, New Jersey, after FDA tests confirmed the presence of Salmonella on the product.
FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and State public health and agriculture officials to investigate a multistate outbreak of Salmonella Enteritidis infections. To date, the CDC reports there are at least 42 illnesses associated with the outbreak in Maryland, New Jersey, New York, Pennsylvania and Virginia.
As part of FDA’s investigation, the Agency collected samples of Turkish pine nuts from a warehouse used by Sunrise Commodities. Additional testing is underway on FDA’s Salmonella positive samples of pine nuts to determine if the Salmonella detected matches the outbreak strain. FDA's State partners also collected samples of pine nuts distributed by Sunrise Commodities; some of those samples tested positive for Salmonella and matched the outbreak strain.
Sunrise Commodities has voluntarily recalled four lots of the implicated product, totaling more than 21,000 pounds of pine nuts. Each lot was packed in 22-pound boxes and included the markings:
Warehouse Lot 27963 with the identifying code “PO#: 50165”
Warehouse Lot 29628 with the identifying code “PO#: 50558”
Warehouse Lot 27713 with the identifying code “PO#: 49595”
Warehouse Lot 27427 with the identifying code “PO#: 50032”
Wegmans Food Markets1, one of the companies that received Turkish pine nuts distributed by Sunrise Commodities, recalled the product from their stores on October 26, 2011. As the investigation continues, additional recalls may take place.
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