The Real Story of Cloud-Based Health Record Security Breaches. A report by Software Advice found extremely few security breaches involving Web-based EHRs, and suggested that they offer advantages over client-server models in that no patient data is stored locally and subject to theft.
PopCap Games To Be Acquired For $1 Billion+. The company behind hits like Plants vs Zombies and Bejeweled is in the process of being acquired, Techcrunch has reported. Among the potential suitors are Zynga, Electronic Arts and several Asian gaming companies.
SMART Health App Challenge Crowns $5,000 Winner. A developer challenge issued this spring by researchers at Children’s Hospital Boston and Harvard Medical School, aimed at inspiring innovation in health IT applications, has awarded its prize to a multilingual EMR interface.
Supreme Court Overturns Ban on Drug Data Mining. The US Supreme Court, on a 6-3 vote, struck down as unconstitutional a 2007 Vermont law that prohibited the collection and sale of physicians’ prescription data without consent.
Guidelines for Cancer Surgery Not Always Followed. Surgical oncologists got a mixed review for adherence to clinical guidelines, including high grades for adjuvant therapy but low marks for nodal management, according to the results of retrospective study.
Oncologists Launch Cancer.Net Mobile App. The American Society of Clinical Oncology has released Cancer.Net Mobile for the iPhone, iPad, and iPod Touch. Covering 120 cancer types, the free app allows patients to manage their treatment and communicate with physicians.
Bedbugs Carry Superbugs. Researchers in Canada have found bedbugs carrying antibiotic-resistant superbugs, including Methicillin-Resistant Staph Aureus. The finding surprised scientists, who thought the pests did not spread infections.
Judge Acquits Ex-Glaxo Lawyer Before Defense Even Starts. The federal government alleged that the lawyer obstructed an FDA investigation into the company’s marketing of Wellbutrin, an antidepressant. The District Court Judge tossed the case before her defense team called a single witness.
Aetna To Encourage Health With Online Gaming. The giant insurer announced a collaboration with Seattle-based Mindbloom to offer an online personal wellness game to its enrollees.
Blacks Suffering Strokes Often Call Friends First, Not 911. A small study showed that most African Americans call a friend or relative instead of 911 when they develop stroke-like symptoms, potentially delaying the onset of lifesaving treatment.
Guilty Pleas Entered in $200M Medicare Fraud Case. Two South Florida companies entered guilty pleas in a Miami federal court for what prosecutors called a “staggering in scope” fraud scheme that falsely billed Medicare for more than $200 million and collected $80 million of the bogus claims.
VA Launches National Genomics Program. Officials described the ‘Million Veteran Program’ as an effort to consolidate genetic, military exposure, health, and lifestyle information into a single database.
ACP Calls for National Strategy on Healthcare for Immigrants. The professional society responds to a South Carolina bill that would make it illegal to transport undocumented persons to a hospital, and other legislative efforts to deny medical care to immigrants.
iMPak Debuts At-Home Sleep Analysis System. Unlike currently available sleep tracking apps which require users to enter data about sleep habits, ‘Sleep Trak’ actually measures the amount and quality of the users’ sleep.
$1.26 Trillion Shortfall in Funds Used To Pay Retiree Benefits. State funds that pay pension and health-care benefits to retired teachers, corrections officers and millions of other public workers faced a cumulative shortfall of $1.26 trillion at the end of fiscal 2009, a new report says.
Vaccine makers won a big victory last week when the Supreme Court ruled by a 6-2 margin that US law effectively protects them from product-liability suits based on claims of poor vaccine design.
The plaintiffs in the case were the parents of Hanna Bruesewitz, who in 1992 received a diphtheria, tetanus and pertussis (DPT) vaccine and subsequently developed a seizure disorder and multiple neurological problems.
The vaccine was made by Wyeth, which was later acquired by Pfizer. Bruesewitz will require expensive medical care for the remainder of her life.
Wyeth had denied that its DPT vaccine caused Bruesewitz’ injuries and warned that an adverse ruling by the Court would presage a flood of similar lawsuits that could threaten the supply chain for childhood vaccines. The Justice Department had supported Wyeth’s position on the matter.
In its ruling, the Supreme Court upheld a decision made by the Court of Federal Claims. In the former case, the Federal Claims court rejected the Bruesewitz’ attempt to receive compensation for medical costs associated with the care of their child. In that ruling, the court argued the parents did not prove that Wyeth’s vaccine caused their child’s injuries.
(The Federal Claims Court, a.k.a. the “vaccine court, was created by the National Childhood Vaccine Injury Act of 1986. Its adjudicates vaccine-injury claims and oversees an associated national compensation program. The vaccine court has awarded nearly $2 billion for vaccine injury claims in 2,500 cases since its inception. Its funds are derived from a tax on vaccines. The Vaccine Injury Act also protects vaccine makers from certain kinds of claims.)
In writing for the majority, Supreme Court Justice Antonin Scalia said the Vaccine Injury Act “pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.” (more…)
Several key health care bowl games will be played in 2011. Their outcomes will affect the health and well-being of a hundred million Americans and help determine the timing of the nation’s inevitable economic double-dip. They’ll also help health insurance CEOs decide whether to re-decorate their offices with fur or linoleum, and who knows? They may even help Mrs. Farquhar find a PCP.
Before you gamble your hard-earned reimbursement check on the outcomes of these tilts, be sure to consult our handy bettor’s guide for insights and advice! We’re so sure we can help you get rich quick, we’re offering these guaranteed locks to youfor free. If you like what you see here and want an even bigger edge, we recommend contacting the experts listed below.
Florida Citrus Bowl Republican-appointed Judges vs. Democrat-appointed Judges: My civics class teacher told me that the judicial branch of government was not subject to partisan politics. So how come every time a GOP-appointed judge rules on the Big O’s health reform law the verdict comes out unconstitutional, and every time a Clinton-Obama appointee rules, it’s cool? This is Bush-Gore 2000 all over again. We know how that turned out. GOP Judges to prevail by a hanging chad.
Sugar Bowl Contrave vs. the FDA: Drug companies have spent billions developing a pill for obesity and have gornisht to show for it. The FDA gonged rimonabant three years ago and trashed Qnexa and Lorcaserin more recently. But in a shocking development last month, FDA scouts said Orexigen’s Contrave was the real deal. Forget that it was minimally effective and had a lousy side-effect profile! The FDA will probably approve it later this month. Over/Under = 10 pounds lost per user. Take the under.
Alamo Bowl Texas Governor Rick Perry threatened to pull his state out of Medicaid, then backed-off amid catcalls from his advisors and top docs in the state. It also dawned on Perry that he’d lose $15 billion a year in federal matching funds if he pulled out, and that Texans would still be paying federal taxes and thus subsidizing Medicaid programs in other states. Perry to win the Grady Little Manager of the Year Award.
Fiesta Bowl EMR companies enjoyed soaring profits and stock prices in 2010, but official scorers refused to re-write the record books saying the performance was wind-aided by HITECH. And even though virtually all reputable EMRs have nailed Meaningful Use by now, their systems still look like they were designed by Rube Goldberg on blotter acid. Fifteen yard penalty for unsportsmanlike conduct!
BCS Championship Bowl The latest chapter in the health reform grudge match between the Pelosis and the Boehners features a new twist now that the latter kicked serious donkey in the midterms. Casual fans can’t figure out if that’s Mitch McConnell or a wax figure of Mitch McConnell on C-SPAN, but it’s not going to matter. Boehners score early and often, and win by 2 touchdowns.
WHAT THE EXPERTS ARE SAYING ABOUT: The Doctor-Patient Relationship MariaYang’s terrific new blog, In White Ink contains short character sketches and vignettes drawn from her work as a psychiatrist and from her observations of the world at large. The pieces are insightful, funny and poignant. In a post titled Lucky, Yang describes a person who hears voices and believes she alone can reunite North and South Korea, yet she is surprisingly capable of an occasional astute observation. In Aging, we observe the mannerisms of an elderly man who is befuddled, if not particularly stressed-out by his surroundings. Our pick to click!
Boomers 2011 is a moving, introspective post by John Schumann over at the GlassHospital Blog. Schumann reminds us that this year, the oldest Baby Boomers turn 65 and hence become eligible for Medicare. Then, to illustrate the challenges faced by these folks, Schumann shares a letter he received from a patient. “Ted” is acutely aware of his growing infirmities, and his letter amounts to a lament for times gone by. Thankfully though, a second patient offers Schumann a fresh approach to helping people like Ted. And the approach has nothing to do with prescribing more drugs or ordering more tests.
Health IT According to Michael Kirsch at MD Whistleblower, electronic medical records (EMRs) are a double-edged sword when it comes to litigation risk. In his post titled “EMRs: Medical Malpractice Shield or Magnet?” Kirsch presents a balanced summary of their risks and benefits in this regard, but in the end Kirsch remains skeptical: “I fear that, at least in the short term, the legal risks for (physicians) exceed legal protections. We need to be vigilant, not only to protect our patients’ health, but also to protect ourselves.”
Quality and Safety In a post titled, Joint Commission: Anti-Safety in Action, WhiteCoat lambasts the agency for designating suicides in the emergency department as Sentinel Events. Writing for the CallRoom Blog, WhiteCoat calculates that the incidence of suicide in the ED is about one per 25 million visits. As a result, ED staff is more likely to win the lottery than find a patient who will commit suicide. Nevertheless, WhiteCoat writes, staff must now be on the look-out for suicidal patients and document its activities every step of the way.
In The Downside of Understanding, Nick Fogelson marvels at the deluge of new medical knowledge that has become available since he entered practice 10 years ago. But as he points out, the new information is often complex and nuanced. It’s a challenge, he writes, to present this information in a way that patients can understand. The post appears at Academic OB/GYN.
Legal Matters
For Ed Pullen, the ongoing litigation involving Myriad Genetics and a bevy of plaintiffs led by the ACLU has taken-on personal overtones. Myriad holds patents on a pair of genes in which certain mutations confer increased risk of breast and ovarian cancer. As a result, it owns exclusive rights to tests that detect these mutations. In BRCA Gene Patent, Pullen explains why the matter has become personal for him, and why he feels the patents should be invalidated.
Regulation
In a scathing, hilarious post titled, Zippity Zappity, Powerbands and AMI, Sheepish lauds recent actions by regulators against 3 companies engaged in quackery and shonky medicine in Australia. Despite the interventions, Sheepish reports in his blog, Paper Mask, that at least one company remains in business, and another still operates a web site (albeit from the USA).
Insurance
Over at Colorado Health Insurance Insider, Louise summarizes the recent expansion of her state’s Medicaid program. The successful expansion, she writes, was driven by a “presumptive eligibility” policy in which applicants are automatically enrolled when they first apply. If they are subsequently determined to be ineligible, they are removed from the program at that time.
Social Media Over at InsureBlog, Henry Stern skewers Oregon Democrat Earl Blumenauer for overlooking a fundamental tenet of life in Internet Age: Never write anything in an email that you wouldn’t want showing up the next day in the New York Times. The Congressman did just that, and sure enough, the next day his top-secret email was reprinted in the Newspaper of Record. To find out what Blumenauer wrote, please see Henry’s post.
Behavioral Health Eating healthier is a common New Year’s resolution, but most people find it tough to undertake wholesale dietary changes overnight. Recognizing this, Dr. Charles presents a manageable list of unhealthy foods that consumers will, hopefully, cross-off their shopping lists. The post is titled 7 + 3 Foods to Avoid. It can be found in The Examining Room.
Recognizing that many people experience painful flares of their gout during the holidays, Irwin Lim presents a timely, patient-focused review of the affliction on the BJC Health Blog. Lim’s post reminds us that flares can largely be prevented with a combination of reduced alcohol intake, dietary modification, weight loss and urate-lowering medications.
In a post titled, Universal Curative Processes, psychologist Will Meek offers a list of 10 behaviors (ranging from accepting one’s self to engaging in creative activities) that he believes can be used by most people to improve their sense of well-being.
Thanks to everybody who submitted posts to this week’s Grand Rounds! Have a great day and best of luck in the New Year!
Buyer Beware: This Bettor’s Guide Picked the Team in Red
Last May, US District Court judge Robert Sweet threw out patents on BRCA1 and BRCA2, a pair of human genes in which mutations are linked to breast and ovarian cancer. In his decision, Sweet ruled the patents were “improperly granted” since they involved a “law of nature.” He rejected the notion that isolating a gene made it patentable, calling that “a ‘lawyer’s trick’” which circumvents the “prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
The BRCA case had been brought by the American Civil Liberties Union, patients and medical organizations. Among other things, they argued that patents drive up testing costs and stifle biomedical innovation.
Sweet’s ruling caused quite a stir at the time, since nearly 20% of all human genes had already been patented, and entire industries had been created around the intellectual property rights granted by these patents.
Myriad Genetics is the company that holds the BRCA patents. It markets a $3,000 test that detects the offending mutations in those genes. Not surprisingly, Myriad appealed the ruling.
What’s New As the appeal moved forward, the US Department of Justice surprised many observers by releasing an amicus brief in which it asserted that human, and indeed all genes should not be eligible for patent protection. This amounted to a complete reversal of its position on the issue.
GeneScience, a pharmaceutical company based in Changchun, China, has pleaded guilty to federal charges that it distributed human growth hormone in the US.
The agreement with US prosecutors requires the company to plead guilty to a felony, contribute $3 million into a “Clean Competition Fund” which supports drug-free sports, and pay $7.2 million in criminal fines. The company’s CEO, Lei Jin, was also required to plead guilty. He was sentenced to five years’ probation.
Nearly all organized sports in the US prohibit competitors from using HGH.
“HGH, when distributed and used unlawfully, poses a serious health threat, particularly to young people who ignore the risks of such substances in an effort to enhance athletic performance,” Peter Neronha told the New York Times. Nerohna is the US district attorney who organized the case against GeneScience.
GeneScience was founded in 1996. It claims to be the most profitable biopharmaceutical company in China. US officials had alleged the company distributed Jintropin, its version of HGH, around the world via the Internet. The company remains in business.
Jin is a Chinese citizen who received a PhD in pharmaceutical chemistry from UCSF. He had previously served as a research scientist at Genentech, a leading supplier of HGH.
Neronha’s case alleged that Jintropin had not been approved by the FDA, and that the company used offshore bank accounts, fake e-mail addresses and a drug trafficking network to distribute large quantities of HGH in the US.
The Clean Competition Fund will be operated by the Rhode Island Community Foundation. It will support antidoping campaigns, clinical research into the long-term effects of HGH and drug screening programs.
Recently, search giant Google filed a lawsuit attempting to prevent what it describes as “rogue online pharmacies” from posting ads alongside its search results and websites.
The complaint was filed in a US District Court. In it, Google claims that an unidentified individual and 50 other defendants “violated policies and circumvented technological measures” when they used its online-ad program, Adwords, to promote prescription-drug operations and pharmacies that had not been approved by the National Association of Boards of Pharmacy.
By doing that, Google claims, the defendants violated their contracts. Google prohibits sites from distributing prescription drugs unless the distributors meet certain criteria, one of which includes verification by the NABP.
Google’s action is just the latest step in the company’s escalating cat-and-mouse game against rogue pharmacies. Every time the company creates new safeguards and guidelines to prevent their activities, the culprits devise more sophisticated methods to circumvent the protections.
Google’s lawsuit was filed the same day that Web address provider eNom Inc. announced a deal to collaborate with the Internet pharmacy verication company LegitScript, to identify and ban Web sites that host illegal online pharmacies.
“Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices,” wrote Google lawyer Michael Zwibelman on the company’s blog recently.
“We work hard to make sure that ads shown on Google provide useful information for our users. But sometimes we need to take action against ads that violate our policies. This is especially true when it comes to advertising for products such as pharmaceuticals, which can be dangerous without the right prescription.”
Unsealed documents from a dispute involving Wyeth Pharmaceuticals show the drug company paid ghostwriters to prepare articles that emphasized positive findings about post-menopausal hormone replacement therapy as part of a strategy to stem growing public concern about the treatment.
The articles include several dozen clinical trial reports and literature reviews. They were reviewed by Adriane Fugh-Berman, an associate professor in the Physiology Department at Georgetown.
Fugh-Berman published her review in PLoS Medicine. She presented her findings while serving as a paid expert witness in a court case brought by 14,000 plaintiffs. These people allege that their breast cancer might have been caused by a Wyeth-made hormone replacement drug known as Prempro.
In her testimony, Fugh-Berman said the ghostwriting strategy included promoting off-label, unproven uses of Prempro such as the prevention of dementia, vision problems, wrinkles and Parkinson’s disease. The strategy also featured a hearty defense of supposed cardiovascular “benefits” of hormone replacement therapy and an attempt to cast doubt about several competing therapies.
The ghostwritten articles were circulated to drug representatives and eventually to physicians.
The ghostwriting outfit at the center of the matter is DesignWrite, medical education and communication company. Wyeth or its representatives apparently paid DesignWrite $25,000 per ghostwritten report of a clinical trial. DesignWrite also wrote 20 review articles, receiving $20,000 a pop.
“The medical profession must ensure that prescribers renounce participation in ghostwriting, and ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” the PLoS study says.
In a statement to Reuters, Pfizer (which now owns Wyeth) tried to dismiss the report. “Even with her critical perspective, (Fugh-Berman) could not establish that there were inaccuracies in any of the peer-reviewed articles, or that their authors relinquished control over their work,” the statement said.
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PopCap Games To Be Acquired For $1 Billion+. The company behind hits like Plants vs Zombies and Bejeweled is in the process of being acquired, Techcrunch has reported. Among the potential suitors are Zynga, Electronic Arts and several Asian gaming companies.
