Archive for Mayo, 2009

Unexpected Bacterial Diversity Found On Human Skin

Sábado, Mayo 30th, 2009

The health of our skin one of the bodys first lines of defense against illness and injury depends upon the delicate balance between our own cells and the millions of bacteria and other onecelled microbes that live on its surface. To better understand this balance, National Institutes of Health researchers have set out to explore the skins microbiome, which is all of the DNA, or genomes, of all of the microbes that inhabit human skin. Their initial analysis, published in the journal Science, reveals that our skin is home to a much wider array of bacteria than previously thought.

The study also shows that at least among healthy people, the greatest influence on bacterial diversity appears to be body location. For example, the bacteria that live under your arms likely are more similar to those under another persons arm than they are to the bacteria that live on your forearm.

“Our work has laid an essential foundation for researchers who are working to develop new and better strategies for treating and preventing skin diseases,” said Julia A. Segre, Ph.D., of the National Human Genome Research Institute (NHGRI), who was the studys senior author. “The data generated by our study are freely available to scientists around the world. We hope this will speed efforts to understand the complex genetic and environmental factors involved in eczema, psoriasis, acne, antibioticresistant infections and many other disorders affecting the skin.”

Drawing on the power of modern DNA sequencing technology and computational analysis, the research team from NHGRI, the National Cancer Institute (NCI) and the NIH Clinical Center uncovered a far more diverse collection of microbes on human skin than had been detected by traditional methods that involved growing microbial samples in the laboratory.

The NIH study involved taking skin samples from 20 sites on the bodies of 10 healthy volunteers. “We selected skin sites predisposed to certain dermatological disorders in which microbes have long been thought to play a role in disease activity,” said study coauthor Maria L. Turner, M.D., senior clinician in NCIs Dermatology Branch.

The researchers extracted DNA from each sample and sequenced the 16S ribosomal RNA genes, which are a type of gene that is specific to bacteria. The researchers identified more than 112,000 bacterial gene sequences, which they then classified and compared. The analysis detected bacteria belonging to 19 different phyla and 205 different genera, with diversity at the species level being much greater than expected.

To gauge how much the skin microbiome differs among healthy people, the researchers studied many different parameters. They found considerable variation in the number of bacteria species at different sites, with the most diversity being seen on the forearm (44 species on average) and the least diversity behind the ear (19 species on average).

The research also generated information that may prove useful in efforts to combat the growing problem of methicillinresistant Staphylococcus aureus (MRSA), a bacterium that can cause serious, even lifethreatening, infections. While it is known that a significant proportion of people have colonies of S. aureus inside their noses, the NIH team checked to see where else on the body surface that these bacteria thrive. They found that the crease of skin outside the nose is the site with the microbial community most similar to that found inside the nose.

“Not only does our work shed new light on understanding an important aspect of skin biology, it provides yet another example of how genomic approaches can be applied to study important problems in biomedical research,” said NHGRIs Scientific Director Eric D. Green, M.D., Ph.D., who is a coauthor of the study. “This also demonstrates what can be achieved through efforts that pull together researchers from across NIH.”

NIH recently launched the Human Microbiome Project, a part of the NIH Roadmap for Medical Research, to discover what microbial communities exist in different parts of the human body and to explore how these communities change with disease. In addition to skin and nose, that project is sampling the digestive tract, the mouth and the vagina.

The skin sites selected for the Science study represent three microenvironments oily, moist and dry. The oily sites included between the eyebrows, beside the nose, inside the ear, back of the scalp, and upper chest and back. Moist areas were inside the nose, armpit, inner elbow, webbed area between the middle and ring fingers, side of the groin, top fold of the buttocks, behind the knee, bottom of the foot and the navel. Dry areas included the inside surface of the midforearm, the palm of the hand and the buttock. Researchers found that dry and moist skin had a broader variety of microbes than did oily skin. Oily skin contained the most uniform mix of microbes.

To look for changes that may occur in the skin microbiome over time, the researchers sampled some volunteers twice, with the samples being taken about four to six months apart. Most of the resampled volunteers were more like themselves over time than they were like other volunteers. However, the stability of the microbial community was dependent on the site surveyed. The greatest stability was found in samples from inside the ear and nose, and the least stability was found in samples from behind the knee.

“Our results underscore that skin is home to vibrant communities of microbial life, which may significantly influence our health,” said the studys first author, Elizabeth Grice, Ph.D., who is a postdoctoral fellow at NHGRI.

Source
Raymond MacDougall

Studies Highlight A Revolutionary New Method Of Treating Post-Operative Bruising

Viernes, Mayo 29th, 2009

Candela Corporation (NASDAQ CLZR) announced that two studies have reported superior results on patients who benefited from the Candela Vbeam® laser treatments for bruising resulting from cosmetic procedures. The studies concluded that the Vbeam pulseddye laser significantly expedited the healing process, improved outcomes, and provided greater overall patient satisfaction.

A study published in the March/April 2009 edition of the Archives of Facial Plastic Surgery, entitled “PulsedDye Laser for Treating Ecchymoses After Facial Cosmetic Procedures” by DeFatta, R. J., Krishna, S., and Williams, E. F., III concluded that “the Vbeam laser treatment resulted in a 63% mean improvement in ecchymoses scores within fortyeight (48) to seventytwo (72) hours.”

The second study, a 2009 ASLMS abstract, entitled “A Simple Solution to a Common Problem” evaluated the effectiveness and safety of the longpulse PDL (the Vbeam) for the treatment of ecchymoses. In this study by Elizabeth Hale, M.D., Julie Karen, M.D., Chris Hunzeker, M.D., Elliot Weiss, M.D., Leonard Bernstein, M.D., Lori Brightman, M.D., Anne Chapas, M.D., and Roy Geronemus, M.D. results showed that twentyfour hours posttreatment with the Vbeam laser, the average improvement was 62% and 13% for treated and untreated bruises, respectively.

Edwin F. Williams, M.D., Director, The Williams Center Plastic Surgery Specialists, and nationally recognized plastic surgeon pioneered this breakthrough Vbeam treatment. “Anytime you penetrate the skin there is a potential for bruising and we find that it is the bruising which occurs after many of these procedures that prevents patients from getting out into the public. It is extremely difficult to cover these unsightly marks with makeup and bruising can last for a number of weeks,” said Dr. Williams. Dr. Williams continued, “After just one treatment with the Vbeam, our patients experience dramatic clearance of the injured blood vessels. This treatment is a significant differentiator to our practice and we are excited to finally be able to offer our patients a safe and easy treatment of bruising that works!”

Roy G. Geronemus, M.D., Director, Laser & Skin Surgery Center of New York, commented, “There are millions of surgical and injectable procedures performed every year which often have bruising as a side effect that can last up to two weeks.” Dr. Geronemus continued, “This is a significant new use for the Vbeam which was already our “workhorse” laser because of its efficacy and safety profile for a wide variety of applications including skin rejuvenation, the treatment of rosacea, acne, diffuse redness, scars and more.”

Source

Opinion Pieces Examine Recent Public Opinion Polls On Abortion

Jueves, Mayo 28th, 2009

Two newspapers recently published opinion pieces on abortionrelated public opinion polls. Summaries appear below.

~ Steven Kull, Baltimore Sun Although “many Americans feel morally conflicted about” abortion, it is a “common error to believe that the American electorate is deeply divided about how the government should deal with” the procedure, Kull director of WorldPublicOpinion.org and the Program on International Policy Attitudes at the University of Maryland writes in a Sun opinion piece. He adds that “there is substantial consensus that the government should not criminalize abortion.” According to Kull, a new CNN poll found that 68% of respondents believe Roe v. Wade should not be overturned, and a recent WorldPublicOpinion.org poll found that when asked, “Do you think the government should be involved in trying to discourage abortion or do you think the government should leave these matters to the individual,” 69% said that the matter should be left to the individual. Kull adds that “of the 29% who said that the government should be involved in trying to discourage abortions, a remarkably low 8% favored using criminal enforcement methods.” According to Kull, other polls have found if “given a middle option somewhere between strict prohibition and government permission a significant number will choose it.” Kull writes that “once the moral question is differentiated from the question of how the government should act, it does appear that there is substantial consensus that abortion should not be criminalized.” He concludes, “Once the option of criminal enforcement is taken off the table, constructive options are more likely to emerge and can be an effective focus for the energies freed up from the incessant debates about abortion” (Kull, Baltimore Sun, 5/22).

~ Cheryl Wetzstein, Washington Times “Its rather ironic that as the most prochoice government in U.S. history settles into its seats,” a Gallup poll “finds that most Americans are prolife,” columnist Wetzstein writes in a Times opinion piece. She adds, “Some observers have tried to poohpooh this result, but it doesnt surprise me for two reasons.” Wetzstein writes that her “experience with youth, both personally and professionally, is that they often recoil at abortion,” adding, “So I find a prolife trend in youth to be quite plausible.” She continues, “Second, I think some aging baby boomers are changing their views,” adding, “People generally become more conservative and selfreflective with age. Legacies matter. Hindsight is 20/20. Regrets appear.” Wetzstein concludes, “My suspicion is that in more than a few cases, baby boomers who were willing to have abortions are not at ease with the idea of losing their grandchildren,” adding, “It may be that in the autumn of life, being prolife has a whole new meaning” (Wetzstein, Washington Times, 5/26).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Intervention Helps Reduce Pain And Depression

Jueves, Mayo 28th, 2009

For patients who experience pain and depression, common coexisting conditions, an intervention that included individually tailored antidepressant therapy and a pain selfmanagement program resulted in greater improvement in the symptoms of these conditions than patients who received usual care, according to a study in the May 27 issue of JAMA.

Pain complaints account for more than 40 percent of all symptomrelated outpatient visits, and depression is present in 10 percent to 15 percent of all patients who receive primary care. Pain and depression frequently coexist (30 percent50 percent cooccurrence), effect the treatment responsiveness of each, and have adverse effects on quality of life, disability, and health care costs, according to background information in the article.

Kurt Kroenke, M.D., of Indiana University School of Medicine and the Regenstrief Institute, Indianapolis, and colleagues conducted a study to determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and coexisting depression. The trial (Stepped Care for Affective Disorders and Musculoskeletal Pain [SCAMP]) included 250 patients who had low back, hip, or knee pain for 3 months or longer and at least moderate depression severity. Patients were randomly assigned to the intervention (n = 123) or to usual care (n = 127). Depression was assessed with the 20item Hopkins Symptom Checklist, and pain primarily with the Brief Pain Inventory.

The intervention consisted of 12 weeks of optimized antidepressant therapy (actively managed by a nurse care manager); followed by 6 sessions of a pain selfmanagement program over 12 weeks (during each session, the nurse care manager introduces new strategies for patient selfmanagement, assists the patient in choosing strategies, and supervises the patient as he/she practices the chosen strategy); and a 6month continuation phase, in which symptoms were monitored and treatments reinforced, with a focus on preventing relapse.

The researchers found that the intervention group had significantly better outcomes for depression. The intervention group was more than twice as likely to experience depression response (46 of 123 intervention patients [37.4 percent] vs. 21 of 127 usual care patients [16.5 percent]) and nearly 4 times as likely to experience complete remission (17.9 percent vs. 4.7 percent) at 12 months, corresponding to a much lower number of patients with major depression (40.7 percent vs. 68.5 percent).

Intervention patients were also much more likely than usual care patients to report overall improvement in their pain at 12 months (47.2 percent vs. 12.6 percent).

In terms of the trials primary outcome, the intervention group was significantly more likely to experience a composite response, defined as a reduction of 50 percent or greater in depression and a reduction of 30 percent or greater in pain. This difference in composite response rates was significant at both 6 months (23.6 percent for intervention patients vs. 7.9 percent for usual care patients) and 12 months (26.0 percent vs. 7.9 percent).

“It is possible that pain improvement in our trial reflected a main effect of improved mood (i.e., an antidepressant effect on mood rather than an analgesic effect), and that as depression lifts, patients may experience pain as being less intense and less disabling. Conversely, it is also possible that the improvement in depression was mediated by an improvement in pain (i.e., as pain improves, patients feel less depressed) or that both depression and pain lessened as a result of treatment effects on a common pathway,” the authors write.

“Because pain and depression are among the leading causes of decreased work productivity, an intervention that is effective for both conditions may further strengthen a business model. Also, an intervention that allows a care manager to cover several conditions rather than a single disorder may enhance its implementation and costeffectiveness. Given the prevalence, morbidity, disability, and costs of the paindepression dyad, the SCAMP trial results have important implications.”

JAMA. 2009;301[20]20992110.

Health Canada Informs Pregnant And Breastfeeding Women Not To Take Vitamin Maxum Matragen And/or Maxum Multi Vite Supplements

Martes, Mayo 26th, 2009

Health Canada is advising expectant mothers and breastfeeding women not to take the vitaminmineral supplements Maxum Matragen or Maxum MultiVite by Seroyal International Inc. Maxum MultiVite has been approved as a vitaminmineral supplement for only the general public but lacks the required cautionary statement on the label regarding pregnant and/or breast feeding women. The product Maxum Matragen is being promoted by the company as a prenatal supplement; however, neither product has been authorized for sale by Health Canada for use by women who are pregnant or breastfeeding.

Both products contain ingredients such as Ginkgo biloba, Green Tea Extracts and Vanadium, whose safe use during pregnancy or in breastfeeding women has not been well established. Products containing these ingredients require a cautionary label warning consumers to consult with a health care practitioner prior to use if they are pregnant or breastfeeding, neither Maxum Matragen nor Maxum MultiVite carries such a warning on their labels.

In addition, the daily doses as labelled for Maxum Matragen and Maxum Multi Vite do not provide the minimum recommended daily dose of 400 mcg of folic acid and the recommended 1620 mg of iron for expectant, pregnant and breastfeeding women.

Health Canada has not received any adverse reaction reports associated with Maxum Matragen and/or Maxum MultiVite. Pregnant or breastfeeding women who may be taking Maxum Matragen or Maxum MultiVite are advised to consult their health care professional prior to continuing use of these products.

The company Seroyal International Inc. has voluntarily recalled these products from the market.

Please visit the Public Health Agency of Canadas website for more information on healthy living during pregnancy.

Consumers requiring more information about this advisory can contact Health Canadas public enquiries line at (613) 9572991, or toll free at 18662250709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways

Report online at the MedEffect™ Canada Web site
Call tollfree at 18662342345
Complete a Canada Vigilance Reporting Form and either
Fax tollfree to 18666786789
Mail to Canada Vigilance Program
Health Canada
AL 0701C

A Persons High Or Low Response To Alcohol Says Much About Their Risk For Alcoholism

Lunes, Mayo 25th, 2009

Someone who has a low level of response (LR) to alcohol, meaning relatively little reaction to alcohol, has a higher risk for developing alcoholuse disorders (AUDs). A study that examined the influence of LR in conjunction with other characteristics like family history of AUDs and age of drinking onset has found that LR is a unique risk factor for AUDs across adulthood and is not simply a reflection of a broader range of risk factors.

Results will be published in the September issue of Alcoholism Clinical & Experimental Research and are currently available at Early View.

“If a person needs more alcohol to get a certain effect, that person tends to drink more each time they imbibe,” explained Marc A. Schuckit, director of the Alcohol Research Center, Veterans Affairs San Diego Healthcare System, professor of psychiatry at the University of California, San Diego, and corresponding author for the study.

“Other studies we have published have shown that these individuals also choose heavy drinking peers, which helps them believe that what they drink and what they expect to happen in a drinking evening are normal,” he said. “This low LR, which is perhaps a low sensitivity to alcohol, is genetically influenced.”

Schuckit and his colleagues examined 297 men participating in the San Diego Prospective Study, originally recruited and tested on their level of reaction to alcohol when they were 18 to 25 years old. Each reported on family history of AUDs, typical drinking quantity, age of drinking onset, body mass index, and initial age at recruitment for the study. AUDs were evaluated at 10, 15, 20, and 25year followups.

Results showed that a low LR to alcohol predicted AUD occurrence over the course of adulthood even after controlling for the effects of other robust risk factors. In short, LR is a unique risk factor for AUDs across adulthood, and not simply a reflection of a broader range of risk factors.

“A low LR at age 20 was not just a reflection of being a heavier drinker at age 20 when we tested these men, and it wasnt an artifact of an earlier onset of drinking,” said Schuckit. “We showed that a low LR at 20 predicts later heavy drinking and alcoholism even if you control for all these other predictors of alcohol problems at age 20.”

Schuckit added that the studys method of examination establishing multiple predictors at age 20, revisiting participants about every five years, and securing a response rate of about 94 percent strongly show that LR is consistent and powerful in predicting alcoholism.”

“Because alcoholism is genetically influenced, and because a low LR is one of the factors that adds to the risk of developing alcoholism,” said Schuckit, “if youre an alcoholic, you need to tell your kids they are at a fourfold increased risk for alcoholism. If your kid does drink, find out if they can drink others under the table, and warn them that that is a major indication they have the risk themselves. Keep in mind, however, that the absence of a low LR doesnt guarantee they wont develop alcoholism, as there are other risk factors as well.”

Its not all bad news, Schuckit added. “We are looking for ways to identify this risk early in life, and to find ways to decrease the risk even if you carry a low LR … so there is hope for the future.”

Source
Marc A. Schuckit, M.D.
Veterans Affairs San Diego Healthcare System

Vaginal Infections symptom Sorter Launches To Help Women Get Diagnosed And Treated

Viernes, Mayo 22nd, 2009

Three quarters (75%) of women with BV (Bacterial Vaginosis) admit the condition has prevented them from getting intimate with their partner, according to a new survey by Balance ActivTM Vaginal Gel.1 Sufferers reveal BV affects their personal relationships more than any other aspect of their lives, with one in ten sufferers resorting to ending relationships as a result of the embarrassing symptoms.1

To help women identify the most common vaginal infections like BV and take appropriate action, Balance ActivTM Vaginal Gel is launching a Vaginal Infections Symptom Sorter supported by Dr Dawn Harper, which is now available as a free download from regainyourbalance.com.

The discreet handbagsized checklist explains the symptoms of BV and is specifically designed to help women initiate a conversation with their GP or pharmacist, avoid embarrassment and get diagnosed. The Symptom Sorter enables women to rule out other common vaginal infections such as Thrush and Trichomoniasis (Trich) and includes handy lifestyle tips for maintaining a healthy vagina.

BV is the most common vaginal infection in the UK and is twice as common as Thrush.2 It is characterised by a fishy vaginal odour, abnormal discharge and vaginal discomfort.* However, its not only the physical symptoms of BV women are enduring; its also having a negative effect on their self confidence. 88% of BV sufferers admit they often feel unattractive, which may be why they are not active in the bedroom. Over three quarters (77%) are too embarrassed to tell their partners.1

Dr Philip Hay, Consultant in Genitourinary Medicine, St Georges Healthcare Trust comments “The condition can cause considerable distress and has a huge impact on womens lives. In my personal experience as a consultant in GU Medicine I have seen many women with BV who are affected emotionally by the physical symptoms that the condition brings. It affects their everyday lives, in work and at home, for example, it is not uncommon for women not to have a sexual relationship if they have recurrent BV, even if they are in a longterm relationship.”

BV is not a STI and is estimated to affect one in three women at some point in their lives,3,4 regardless of their sexual behaviour. However, having sex without a condom, the contraceptive coil and using intimate products can change the pH of the vagina and bring on symptoms of BV.

References

1. Online BV sufferers survey on regainyourbalance.com (178 participants surveyed between Aug 2008 and Jan 2009)
2. Bacterial Vaginosis patient.co.uk
3. The Family Planning Association fpa.org.uk
4. Society of Sexual Health Advisors ssha.info

Live Procedure Webcast: InterStim(R) Testing Procedure For Treatment Of Urinary Disorders

Viernes, Mayo 22nd, 2009

More than 35 million Americans suffer from bladder control problems at some time in their lives. Those suffering from uncontrollable bladder may experience unexpected urine leakage, frequent bathroom use, or have the feeling of not being able to completely empty the bladder. Many people experience a combination of these symptoms. Although it is more common in older adults, and more likely to occur in women than men, it can affect anyone.

For many of these people the last hope is an implantable device known as InterStim® Therapy, which was designed to stimulate communication between the brain and bladder to better control urinary incontinence and retention. Before the device can be implanted, however, doctors must perform a test procedure to determine if it will be effective.

At 4 p.m. on May 20, 2009, this test procedure will be performed live over the Internet from Tampa General Hospital. The test involves placing a thin wire near the tailbone, which is connected to a small stimulator worn on a belt. The stimulator sends mild electrical pulses through the thin wire to the sacral nerves that control the bladder and muscles related to urinary function.

The test is an outpatient procedure typically completed in less than an hour. The patient is placed under a local anesthetic. After the procedure, the patient keeps a journal for a period ranging from five to ten days. If the electrical pulses result in an increase in proper bladder function, the patient may proceed to the surgical implementation procedure.

Raul Ordorica, M.D., Associate Professor, Division of Urology, University of South Florida College of Medicine, will perform the procedure to test the effectiveness of the InterStim® device. Dr. Ordorica has had extensive experience with InterStim® Therapy since it was FDA approved in 1998, and was the first to perform the implant at Tampa General Hospital. The procedure will be narrated by Mark Swierzewski, M.D., Florida Urology Partners.

To view this procedure, log on to tgh.org and click on the link on the homepage. If you are unable to view the live broadcast, the procedure will be available on demand at tgh.org and ORLive.com for future viewing at your convenience.

Source

New Study Reveals Wide Variations In Depression Diagnoses Among Ethnic Groups

Jueves, Mayo 21st, 2009

Whites experiencing depression are far more likely to be diagnosed by a physician than other ethnic groups, according to a new Consumer Health Sciences (CHS) study presented today at the 14th Annual ISPOR (International Society for Pharmacoeconomic and Outcomes Research) Conference in Orlando, Florida. The study reveals that 76% of whites with selfreported depression symptoms are officially diagnosed, compared to just 58.7% of blacks, 62.7% of Hispanics and 47.4% of Asians.

Findings also show strong differences among ethnic groups in the prevalence of depression among the four ethnic groups studied. Of the 53.8 million Americans reporting they suffer from depression a quarter of the US population 25.8% are white, 19.8% are black, 27.6% are Hispanic and 16.1% are Asian. (Respondents who were not among the four ethnic groups being examined were excluded from the study.)

“Although the differences in prevalence are significant, the wide variations in diagnosis rates are particularly critical and alarming, since patients must be diagnosed to be treated,” says Michael Fronstin, Chief Operating Officer of CHS. “While we are unsure of the cultural or socioeconomic drivers behind those variations, it is clear that steps must be taken to provide both patient and physician education programs that support increased diagnoses and more timely therapy for minority patients.

“One of the issues the research uncovered is that patients dont associate depression symptoms with the actual condition. We must provide the tools and training for medical providers and patients to be able to discuss depression, as well as its specific symptoms, in culturally relevant terms that ensure those who are suffering get the help they need.”

Reporting Symptoms Does Not Mean Recognizing Depression

The CHS study assessed depression by asking respondents if, over the last month, they have often experienced being down, depressed or hopeless and/or having little interest or pleasure in doing things. The results show a clear disconnect between patients reporting depression symptoms and recognizing the underlying condition.

Of those who do not self report having depression, 11.5% of whites, 12.5% of blacks, 13% of Hispanics and 12.7% of Asians indicate they are suffering from one of the depression symptoms. In addition, 10.1% of whites, 11.5% of blacks, 12.9% of Hispanics and 11.2% of Asians not selfreporting depression are, in fact, experiencing both symptoms.

“While recommendations have been made at the policy level to increase access to care and treatment for minority patients, thats just part of the solution,” says Fronstin. “We also must raise both physician and patient awareness of the importance of talking openly about symptoms.”

About the National Health and Wellness Survey (NHWS)

The studys results were drawn from the 2008 US National Health and Wellness Survey (NHWS), a nationally representative, selfadministered survey conducted annually via the Internet. Topics covered include the health status, attitudes and outcomes among adults 18 or older.

CHS, a Kantar Health company, conducts NHWS annually in the US, Europe and Asia. The survey is the largest selfreported patient database in the healthcare industry.

Sixteen States, DOJ Join Whistle-Blower Lawsuits Alleging Wyeth Defrauded Medicaid Programs

Miércoles, Mayo 20th, 2009

The U.S. Department of Justice and 16 states have joined two whistleblower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports. The lawsuits were initiated following a grandjury investigation by the U.S. Attorneys Office in Massachusetts (Johnson, Wall Street Journal, 5/19). The other states included in the lawsuits are California, Delaware, Florida, Illinois, Indiana, Louisiana, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia (Barrett, AP/Austin AmericanStatesman, 5/18).

According to the lawsuits, Wyeth from 2000 to 2006 sold hospitals a bundled package called the Protonix Performance Agreement, which included its acidreflux drugs Protonix Oral and Protonix IV. The suits allege that Wyeth gave hospitals up to a 94% discount for the oral version under the deal, with the understanding that when patients were released from hospitals they would be switched from the intravenous version of the drug to the oral version. According to the complaint, Wyeth hoped to gain an edge in a competitive market for acidreflux pills by taking advantage of its standing as the only company offering an IV acidreflux drug. The Journal reports that Wyeth charged hospitals $20 per vial for the IV version of Protonix and $3 for the oral version.

Medicaid rules stipulate that the program is entitled to the lowest price on prescription drugs, and drugmakers are required to pay states rebates if they offer discounts to any other entities. The lawsuits state that Wyeth avoided paying hundreds of millions of dollars to state Medicaid programs because it did not offer the programs the same discounts or provide rebates (Wall Street Journal, 5/19).

The lawsuits are seeking financial penalties against Wyeth of up to three times the amount lost by Medicaid. Assistant Attorney General Tony West said, “By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have.” Wyeth spokesperson Doug Petkus said that Wyeth “believes that its pricing calculations were correct and intends to defend itself vigorously in these actions” (AP/Austin AmericanStatesman, 5/18).

Reprinted with kind permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.