Budget Impasse Unlikely To Affect EHR Incentive Payouts. Despite the ongoing stalemate in federal budget negotiations, it is unlikely that Congress will eliminate future funding for incentive payments for the meaningful use of electronic health records, according to David Roberts, VP government relations at HIMSS.

Greenway Medical Files to Go Public. The vendor of integrated physician practice management/electronic health records software has filed for a $100 million initial public offering of stock.

Tobacco Use in Movies Continues Dramatic Drop. The number of onscreen tobacco incidents in youth-rated (G, PG, or PG-13) movies continued a downward trend, decreasing 71.6% from 2,093 incidents in 2005 to 595 in 2010, the CDC reported. The rate of decline varied substantially by motion picture company.

Kids Safer With Granny Behind the Wheel. Grandma may be better behind the wheel than mom when it comes to injuries from car crashes involving children, an insurance database showed.

Supply of Essential Medicines Falls Short in US Hospitals. Shortages of common medicines have reached a record high and are a nearly universal problem for community hospitals in the US, where the problem is leading to rationing and higher costs for care.

Quit Smoking Drug Linked to Cardiovascular Risk. Users of the smoking-cessation drug varenicline (Chantix) who had no previous cardiac history had a small but statistically significant increase in the risk of cardiovascular events, a meta-analysis of randomized trials showed.

Tracking Public Health Trends with Twitter. Scientists studied 1.5 million health-related tweets from a public cache and claimed they were a “useful source of public health information.” Tidbits included which OTC medicines people used to treat certain symptoms, as well as intriguing patterns about allergies, flu, insomnia, cancer, obesity and depression.

Telehealth Services Could Qualify for Payment under CMS Rule. In the proposed rule, tele-stroke, tele-ICU and other established telehealth services can qualify for payment if they provide a “clinical benefit.”

Studies Examine Autism’s Link to Antidepressants, Other Factors. A study finds women who take antidepressants during pregnancy have a moderately higher risk of having a child with autism. A separate study of twins suggests that environmental factors play a significant role in its development.

HHS to Simplify Electronic Transactions for Physicians. The Department of Health and Human Services has issued an interim final rule aimed at cutting red tape for providers transmitting information electronically.

Uncertainty About Autism Prevalence Persists. Findings from a recent study that more than doubled the estimated prevalence of autism may represent a true increase, an expansion of what is considered a disorder, or both.

Lancet Study Focuses on Readiness for Flu Pandemic. The study reviews recent developments in vaccine research, and distribution. It finds some reasons for optimism and makes some sobering observations as well.

Pfizer To Cut Another $1 Billion in Annual Spending.  Pfizer plans to slash an additional $1 billion in expenses, beyond the billions of dollars in previously announced cuts to research and development.

Proteus Biomedical Teams with Avery Dennison on Patch-Based Wearable Sensors. Avery Dennison, known for its self-adhering labels, is partnering with digital health startup Proteus Biomedical to make patch-based wearable sensors that can monitor vital signs.

Grand Rounds Has Been Posted! This week’s edition was authored by David Williams of Health Business Blog. The edition features a post from Pizaazz on the lack of female CEOs in Health IT.

Unicef Reveals Vaccine Prices. Unicef, one of the world’s largest vaccine buyers, is now publishing the prices it pays individual companies for immunizations. Public health officials hope the move will boost competition and drive down prices for all vaccine buyers.

Will Doctors Heed IBM’s Watson? History Indicates Otherwise. IBM’s supercomputer is being groomed to advise doctors about diagnoses and treatments. But there’s no guarantee physicians will heed its advice, even if it delivers more accurate answers faster than other decision support tools.

Facebook to Pharma: Comments Allowed. The social networking site has told pharmaceutical companies that as of August 15, they will no longer be able to disable the comment feature on their Facebook pages.

Scientists Find an ‘Ultra-Bad Cholesterol’. Ultra-bad cholesterol is more likely than LDL (bad) cholesterol to attach to arterial walls and form plaques. It is more prevalent in the elderly and those with type 2 diabetes.

App Helps Diagnose Concussions in Youth Sports. When a child suffers a potential concussion while playing a sport, parents and coaches can find out what to do from an app on their iOS and Android devices.

The use of Motrin, Aleve and other non-steroidal anti-inflammatory drugs (NSAIDS) is associated with erectile dysfunction, according to a study by scientists affiliated with Kaiser Permanente.

The apparent link surprised the scientists. They had hypothesized that the commonly used pain-killers would actually reduce the risk of erectile dysfunction since NSAIDS protect against heart disease, which has in turn been linked to the troubling condition.

To reach their surprising conclusion, Steven Jacobsen and colleagues used data from Kaiser’s HealthConnect EHR, an associated pharmacy database, and self-reports about NSAID use and erectile dysfunction from an ethnically diverse population of 80,966 men between the ages of 45 and 69.

After controlling for age, ethnicity, race, body mass index, diabetes, smoking status, hypertension, high cholesterol and coronary artery disease, the scientists found that men who used NSAIDS at least 3 times per day for at least 3 months were 2.4 times more likely to experience erectile dysfunction than those who did not consume them on a regular basis. The link persisted across all age categories.

Remarkable in its own right was the finding that overall, 29% of the men in the study reported some level of erectile dysfunction.

The authors emphasized that their findings do not prove that NSAID use causes erectile dysfunction. For example, the study findings could have been confounded by factors not considered by the scientists (such as subclinical disease or the severity of the comorbid conditions that were studied), and the chance that NSAID use was actually an indicator for other conditions that caused erectile dysfunction.

In addition, the scientists recognized that their study had some limitations. These included an inability to temporally link NSAID use and the development of ED, and possible selection bias.

As a result, they cautioned men against discontinuing NSAIDs based solely on the findings of their study. “There are many proven benefits of non steroidals in preventing heart disease and for other conditions. People shouldn’t stop taking them based on this observational study. However, if a man is taking this class of drugs and has ED, it’s worth a discussion with his doctor,” Jacobsen said in an interview.

The write-up appears in the Journal of Urology.

Spring training 2011 is in full swing. With baseball’s regular season just 2 weeks away, pitchers are lengthening their starts and adding curveballs to the mix. Promising, but lamentably green prospects are being reassigned to Triple A. And word has it that Mariano Rivera is preparing to throw an inning or two, just to be sure his 4-seamer is game-ready before opening day.

People have said that Baseball is Life. That may be stretching it for folks not named Yogi, but surely the game holds lessons for us all…even health policy wonks! Before we highlight the top submissions to this week’s HWR, let’s review some of these lessons:

Lesson 1: People Will Believe Anything
Somewhere this spring, a local sports writer opined that the kid who touched 98 in the 6th inning of a Cactus League game is the next Tim Lincecum, even though he has never recorded a regular-season out above Double A. Another said this year’s Phillies’ rotation will match the prodigious ‘71 Orioles quartet of Cuellar, McNally, Palmer and Dobson. Others claimed that A.J. Burnett will win 20 this year, and that Vlad Guerrero (whose gait is reminiscent of the Tin Man in Wizard of Oz) will steal 20 bases.

And people believe it!

During the epic health reform debate of 2009-2010, Democrats tried to include provisions which authorized payments to physicians for time spent helping Medicare patients prepare living wills. But Sarah Palin claimed those provisions allowed the government to create “death panels,” and John Boehner warned that they would “start us down a treacherous path toward government-encouraged euthanasia.”

People believed that, too!

To this day, an astounding 30% of elderly Americans believe the new health law empowers government panels to make end-of-life decisions for Medicare beneficiaries.

Lesson 2: Sometimes You Get a Do-Over, Sometimes You Don’t
Umpire Jim Joyce robbed Tigers pitcher Armando Galarraga of a perfect game last year when he blew a call on what should have been the last out of the game. Although Joyce later admitted his mistake, there are no do-overs in baseball. The pitcher’s chance to make history was gone forever.

Meanwhile, GOP-appointed Federal District Judge Robert Vinson decided in January that since he found one provision of the Big O’s health law to be unconstitutional, he might as well trash the whole deal. The decision threatened to disrupt planning in 50 states and confused the bejesus out of the American public. But unlike baseball, the US judicial system does permit do-overs…sort of. Two weeks ago, Vinson issued a stay of his own ruling, effectively allowing the law to stand pending an appeal to the Supreme Court.

Galarraga would be immortal if Joyce could have done that!

Go figure. Anyway, the Yankees will rise again in 2011 (believe me!) and finally, thanks to the HWR All-Stars who contributed posts for this week’s edition. Here is the formidable line-up:

The Sluggers (Health Policy)
For his post on the Forbes website, Avik Roy produced a chart showing results from the Health Tracking Study Physician Survey. The chart confirms that physicians refuse to accept Medicaid patients at rates that far exceed those who are covered by Medicare and private insurance. Roy suggests this problem is responsible for poor clinical outcomes seen in Medicaid beneficiaries.

Between innings, Roy should have a beer with Austin Frakt, who pretty much blows-up the premise that Medicaid recipients receive poor quality health care. In a post for the Incidental Economist, Frakt shows that studies used to support the premise reveal an association between Medicaid and individuals with poor health… it’s their poor health, Frakt says, that is driving poor outcomes in this population, not lousy doctors or poorly designed care systems.

Now that President Obama has decided to support Wyden-Brown, disaffected governors and state legislators can craft PPACA alternatives that are more to their liking, writes Joe Paduda over at Managed Care Matters. According to Paduda, if Republicans actually have a better approach to the problems of health care access and cost, they are going to win big in 2012.

For his part, John Goodman predicts that the PPACA will encourage many patients and providers to opt-out of the third-party payer system. Posting on his own Health Policy Blog, Goodman visualizes a major shift toward concierge-type services and the creation of new markets in which providers compete for patients on price, quality and amenities.

Neil Versel is a huge fan of Don Berwick, but he deplores the way President Obama attempted to install the Quality Don as a recess appointment to head CMS in July, 2010. According to Versel, the underhanded nature of the appointment provided fodder for “uninformed ideologues and assorted nut jobs to attack Obama’s healthcare reform efforts.” Versel’s blog is Meaningful HIT News.

Over at BNet Healthcare, Ken Terry observes an accelerating trend in which insurers and providers are partnering to create Accountable Care Organizations. Terry believes the 2 groups actually can cooperate to form such organizations, and cites several recent acquisitions and partnerships which appear to support his position.

Marsha Gold has followed the Medicare Advantage program and its predecessors for years. In her post on the Health Affairs Blog, she summarizes the program and describes how its beneficiaries will be affected by the PPACA.

In a post for his Health Business Blog, David Williams reminds us that many folks want to overturn new rules restricting Flexible Spending Accounts. Williams ups the ante a bit by suggesting that we eliminate FSAs altogether, and get rid of those pesky tax deductions for health insurance while we’re at it.

David Kindig reviews the implications of Wisconsin Governor Scott Walker’s plan to eliminate the state’s $3.6 billion dollar deficit. Kindig argues that some of Walker’s proposed cuts (including reducing Medicaid eligibility) will have serious health implications for people in his state. His post appears at Improving Population Health.

The Lucidicus Project’s Jared Rhoads reacts to presentations he heard at the TEDxDartmouth 2011 conference. After hearing Al Mulley’s familiar argument that our health system needs to adjust more effectively to consumer preferences, Rhoads doesn’t believe we can pull it off.

Reconciling state and federal laws can be difficult, and according to Louise Norris of the Colorado Health Insurance Insider, Health Reimbursement Arrangements (HRAs) are a particularly nettlesome case-in-point in her home state. Her post clarifies the situation, thankfully.

The Starters (Providers)
Roy Poses describes how physicians who are employed by corporations can be pressured to put the corporations’ economic interests ahead of their patients’ interests. Writing for Health Care Renewal, Poses argues that the primary means of corporate control includes restrictive covenants in contracts that have been signed by naive physicians, or signed by physicians under duress.

The PPACA will eventually generate a huge increase in the number of ER visits, according to Amer Kaissi. He argues that better coordination between ER and primary care doctors will be required to address the coming deluge, and offers a roadmap for this effort. Kaissi posts on Healthcare Hacks.

Julie Ferguson of Workers Comp Insider writes that nurses, nurses’ aides and paramedics are facing a rising tide of on-the-job violence. In fact according to Ferguson, only police and correctional officers experience higher rates of on-the-job assaults. Ferguson explores whether this is emblematic of a dysfunctional health system or just a sign of the times.

Liz Borkowski reminds us that while palliative care teams can reduce costs associated with the care of seriously ill hospitalized patients, most people who are eligible for these services don’t receive them. Borkowski, who posts at The Pump Handle, concludes that we have to do more to encourage utilization of these teams.

On The Health Care Blog, Matthew Holt posts an interview with JD Kleinke concerning the latter’s new novel, Catching Babies. Holt describes the book as a “tour de force of health policy and medical soap opera–Health Affairs meets Grey’s Anatomy–wrapped up in the complex world of childbirth.”

The Closers (Quality and Safety)
There is limited evidence to support claims that pay for performance programs improve quality and reduce the costs of health care, according to Jason Shafrin, who posts on The Healthcare Economist. Shafrin reviews Massachusetts’ pioneering P4P program and several other ones that failed to improve care.

Jaan Sidorov laments that a one-size-fits-all approach to health care—characterized by guidelines and decision support—is woefully behind sociotechnical trends that make “mass personalization” possible. Writing for Disease Management Care Blog, Sidorov argues that those who embrace the latter approach (by tailoring treatments based on the health status, preferences and values of individual patients, for example) will win in the marketplace.

At The John A. Hartford Foundation Blog, Chris Langston discusses the problem of overmedicating the elderly. He reviews a study in which 42% of the Indiana Medicaid population who live in nursing homes received at least one “potentially inappropriate medication.” Not surprisingly, these patients had worse health outcomes.

-Seventh Inning Stretch-
Famed HWR Contributor Argues Against a Key Policy Decision:

www.youtube.com/watch?v=xs0SinIno7A

The Base-Stealers (Health IT)
Many CEOs and CIOs believe that their healthcare IT systems are secure because they “use SSL encryption” or “have a firewall.” That’s not the case, according to The Healthcare IT Guy, Shahid N. Shah. Shah offers a list of questions that executives can use in order to assure their systems really are secure.

Walking through the palatial vendor displays at this year’s HIMSS conference, Anticlue blogger Elyse Nielsen heard surprisingly little buzz about “the cloud.” In her post, Nielsen explains why this was the case, and opines that it won’t be long before the buzz picks-up.

The Slick Fielders (Pharmaceuticals)
Over at Nuts for Healthcare, Jeffrey Seguritan wonders what things would be like if drugs and their makers were forced to endure the same mano-a-mano competition that makes the NCAA basketball tournament such a good watch. Although the FDA does not require comparative trials like this before green-lighting drugs, Seguritan reviews a few such trials that are actually underway.

The Five-Tool Guys (Media)
Lately, health media watchdog Gary Schwitzer has focused on instances in which press releases drive what we call “news” in health care. In a pair of posts on his HealthNewsReview Blog (here and here), Schwitzer warns that when this happens, independently vetted journalism may not have taken place. 

The Stud Prospects (Consumerism)
Employers and health plans continually seek ways to contain health care costs. According to Dave Kerrigan, limiting the size of provider networks is a powerful and potentially beneficial tool in this regard. Kerrigan’s post appears on A Musing Healthcare Blog.

The Rabid Fans
Nobody is immune from DrRich’s sharp-tongued post on The Covert Rationing Blog. DrRich skewers, in no particular order, lying doctors, the right-wing media, the left-wing media, and quite possibly my Aunt Millie as well. We’re not sure what DrRich is for, but we know what he’s against, and it’s just about everything.

“Unions get waivers,” the InsureBlog’s Bob Vineyard exclaims. “Campaign contributors get waivers. Business owners and states get waivers. Why should consumers be left out?” In his post, Vineyard points out that some Michigan Representative wants to give consumers the right to opt out of “Obamacrap.” Obamacrap? Really? Obamacrap?

Whatever. Two weeks from today, Jason Shafrin hosts the Health Wonk Review over at the Healthcare Economist. Good luck Jason, and thanks to the all-stars who contributed to today’s edition!

When the so-called “atypical antipsychotic” drugs became available for the treatment of schizophrenia, physicians began prescribing them like crazy because they did not cause debilitating extrapyramidal side effects like their predecessors. As we described previously, relentless and occasionally unscrupulous marketing campaigns by drug makers also drove utilization of the newer agents.

Unfortunately, the atypical agents turned out to have a nasty side-effect profile of their own. They promote obesity and diabetes, increase the risk of cardiovascular events, precipitate tics and increase mortality in elderly patients with dementia, among other things.

The weight gain/diabetes problem is particularly severe in children—a demographic in which these agents are rarely indicated. In one study for example, the drugs caused youths between the ages of 4 and 19 to gain between 10 and 19 pounds on average in just 11 weeks.

What’s New?
Recently, G. Caleb Alexander and colleagues at the University of Chicago reviewed historical trends in the use of atypical antipsychotics and published their findings in Pharmacoepidemiology and Drug Safety. It’s a largely confirmatory study, and the picture they paint is not pretty.

Caleb’s team queried nationally representative data from IMS Health’s National Disease and Therapeutic Index to characterize prescribing behavior for antipsychotic drugs in outpatient settings.

They found that overall, antipsychotic use (including atypical antipsychotic and first-generation agents) nearly tripled from 6.2 million treatment visits in 1995 to 16.7 million visits in 2008. For children, the number of treatment visits involving an antipsychotic increased 8-fold, from 0.3 million in 1995 to 2.4 million in 2005. And as expected, the scientists documented a tectonic shift in prescribing patterns: in 1995, 84% of the prescriptions for antipsychotic agents were for first-generation agents, whereas  by 2008, 93% of them were for atypical agents.

As physicians prescribed fewer first-generation agents, they tended to use them more specifically for schizophrenia, the indication for which they were initially approved by the FDA (30% in 1995 vs 48% 2008). On the other hand, the prescribing tsunami for atypical agents was accompanied by a three-fold increase in prescriptions for bipolar disease (10 to 34%) and a marked cut in their use for schizophrenia (56 to 23%). the now infrequently used typical agents.

On the cost side, the total cost of typical antipsychotics—which are now available in generic form–was $0.6 billion in the US in 2008, whereas that for atypical drugs was $9.9 billion.

Overall, antipsychotic use for non-FDA approved indications rose from 4.4 million visits in 1995 to 9.0 million in 2008. The scientists estimated the cost associated with off-label use of these drugs to be $6.0 billion in 2008, alone.

These trends occurred even though scientists have yet to prove that the atypical agents offer a clear advantage over their older congeners, when both efficacy and side-effects are considered, Caleb’s group said.

“Recent trials failing to demonstrate clinically significant differences in the effectiveness of these two classes in schizophrenia raise the question of whether typical antipsychotics should be reconsidered as a first line therapy, given that the superiority of atypical agents has yet to be established,” they wrote.

“Our results…suggest a substantial exposure to therapies for clinical indications that have not received regulatory scrutiny and where the evidence base is uncertain.”

Wonderful.

Last year was another lackluster one for the drug and biotech industries, as the FDA seemed to ratchet-up its scrutiny of trial data and set the bar higher on requirements for drug efficacy. Overall, the regulatory agency approved 24 new drugs in 2010, which was slightly down from the 26 it approved in 2009 and dead-even with the 24 it approved in 2008. Only 17 were approved by the FDA in 2007

Two of the newly approved drugs appear to have a shot at becoming blockbusters: these are Gilenya, which is Novartis’ pill for multiple sclerosis, and Provenge, Dendreon’s injectable treatment for advanced prostate cancer. A pair of much-anticipated obesity drugs, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa were rejected by the FDA, as were many others. Perhaps the biggest news however, focused on the FDA’s handling of safety issues surrounding drugs it had approved in previous years. Here’s a summary of some winners and losers:

Newly Approved Drugs
Multiple Sclerosis-Patients with multiple sclerosis did have a good deal to cheer about last year. In addition to Gilenya, the FDA approved Ampyra (Acorda Therapeutics) to improve gait disturbances in MS patients.

Advanced Prostate Cancer-Dendreon finally won FDA approval for its cancer-fighting vaccine, Provenge. The regulatory agency had previously rejected the drug and required that additional trials be performed, despite early clinical trials which were generally positive.

Stroke Prevention-Drug makers have been vying for years to replace warfarin, the widely used anticoagulant that has been available for more than half a century. After receiving approval for its drug, Pradaxa to prevent stroke in patients with cardiac arrhythmias, Boehringer Ingelheim now has a head start in this highly lucrative field.

Emergency Contraception-HRA Pharma’s drug ella, was approved by the FDA last summer. It blocks pregnancy up to five days after sexual intercourse, a full-day longer than other drugs on the market. The drug is now marketed in the US by Watson Pharmaceuticals.

In Limbo
Stroke Prevention-The FDA asked AstraZeneca for more information from a generally positive study of the anticoagulant, Brilinta assuring a longer glide path to market for Boehringer’s entry into this space (see above).

Lupus-Similarly, the agency announced it wanted more time to study trial results regarding Benlysta, a much anticipated lupus drug produced by Human Genome Sciences and GlaxoSmithKline.

Newly Restricted or Removed
Diabetes-In arguably its biggest call of the year, the FDA sharply curtailed utilization of Avandia, GlaxoSmithKline’s diabetes drug after post-market surveillance studies linked it to an increased risk of heart attacks.

Obesity-It was truly a dismal year for drug companies hoping to cash-in on the global obesity pandemic. In addition to rejecting the new drug applications for lorcaserin and Qnexa, the FDA removed Abbott’s  Meridia from the market, because its relatively low efficacy didn’t justify its tendency to increase cardiac risk.

Pain Management-The  makers of Darvon and Darvocet decided to pull these drugs from the market as well, in this case because of longstanding concerns that they provoked cardiac arrhythmias.

Breast Cancer-Just before year-end, the FDA announced it planned to revoke the approval it had given to Roche’s Avastin for the treatment of breast cancer, because the drug didn’t improve life expectancy and was associated with venous thromboembolism. The move won’t affect other FDA-approved uses of the drug. Roche is appealing the decision.

No one would be surprised if, in a quiet moment, Ian Read confided that he doesn’t know what hit him.

Reid became CEO of Pfizer a few weeks back, following Jeffrey Kindler’s unexpected retirement. He took the lofty position knowing that his biggest task in the short-term would be to replace nearly 20% of the company’s annual revenues, more than $11 billion, beginning later this year when Lipitor loses patent protection.  He knew as well that Pfizer could make a good start in this regard if it could rapidly expand sales in emerging markets like China.

But he probably didn’t know that 2 people who were set to lead Pfizer’s international expansion would bolt the company soon after Kindler departed, or that a monumental regulatory shift in China was about to be announced, a move that could potentially cripple the company’s expansion plans in that country. And he almost certainly didn’t know his company would be ensnared by the WikiLeaks data dump as well.

Here’s a quick brief on the unexpected developments facing Read and Pfizer:

China-Last week, China’s National Development and Reform Commission cut prices on a host of drugs by an average of nearly 20%. Drugs on the list included Pfizer’s oral diabetes agent, glipizide (Glucotrol), and azithromycin (Zithromycin), an antibiotic.

“All the excitement about emerging markets is fine and good, but these countries are learning very fast how to contain the cost of medicines,” William Looney, the editor of Pharmaceutical Executive and a former Pfizer staffer in emerging markets told the Wall Street Journal. That may “tamp down the growth.”

Pfizer’s emerging market sales account for roughly 18% of the company’s top line, and these revenues have grown by 40% this year. Read has gone on the record stressing the need to leverage this opportunity.

Exodus-The 2 executives that followed Kindler out the door were Steve Yang and Jean-Michel Halfon. Yang had spearheaded Pfizer’s program to develop drugs in Asia. He was apparently poached by AstraZeneca. Yang is reportedly well-connected with physicians and scientists in China and knows the ropes when it comes to clinical research and trial implementation in that country. Halfon was the head of the company’s emerging markets division since its inception 2 years ago.

WikiLeaks-A leaked diplomatic cable from the US Embassy in Nigeria suggests that Pfizer hired investigators to “uncover corruption links” and other scandalous information about the country’s attorney general in an effort to persuade the Nigerian government to drop lawsuits it had filed concerning a Pfizer-funded clinical study.

The trial in question took place in 1996, and involved Pfizer’s antibiotic, Trovan. During that trial, 11 children died in a local outbreak of bacterial meningitis.

The cable was sent during settlement talks between the drug giant and Nigerian federal and state governments. The latter had claimed that Pfizer tested the antibiotic without obtaining consent from parents of children involved in the study. Pfizer responded that the deaths were caused by the infection, not the drug, and that it had obtained proper consent.

Pfizer reached a $75 million settlement with a state government in Nigeria soon after the cable was sent, and shortly after that, it settled with the Nigerian federal government. Pfizer has ridiculed the claims made in the cable as being “simply preposterous.”

A company the size of Pfizer can move-on rather easily from a fiasco like WikiLeaks-Nigeria, but as for the other matters mentioned above, let’s just say that Ian Read knows quite well the exact date his company’s Lipitor patent expires, and that the clock is ticking.

The FDA has been tough on diet drugs of late. Three years ago, it scuttled an attempt to get the European diet drug rimonabant approved for use in the US. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin.

But that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure.

The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the 3 diet drugs mentioned above,  it usually does.

Orexigen has petitioned the FDA to approve Contrave for the treatment of obesity and weight management in people who have a body mass index of at least 30, or at least 27 if they have at least one cardiovascular disease risk factor like diabetes, high cholesterol or high blood pressure.

Contrave is a combination of 2 drugs that were approved long-ago by the FDA and are widely used today. Naltrexone, the first of these, is used to treat opioid addiction and alcohol dependence. The second, bupropion, is used to treat depression and as a quit-smoking aide.

Before reaching its verdict, the FDA’s Endocrine and Metabolic Drugs Advisory Committee reviewed the results of 4 randomized trials that were sponsored by Orexigen. Together, the studies enrolled more than 4,500 overweight and obese subjects. The Committee noted that in pooled results from the 4 trials, the weight-loss difference between those receiving Contrave and those receiving a placebo was about 4.2%, which it deemed to be “of nominal statistical significance.” However, more than a third of subjects in the Contrave group did lose least 5% of their body weight during a 1-year follow-up period.

“As far as efficacy goes, I think they made it by the hair of their chinny chin chin,” Melanie Coffin, a patient representative on the Committee told ABC News.

The Committee did raise concerns about several side effects of Contrave, including seizures and suicidal ideation, although it was clearly most concerned about the drug’s tendency to increase blood pressure, a phenomenon that seemed to be most apparent in the first few weeks after the drug was started. Ultimately though, the Committee decided there wasn’t enough data to draw clear conclusions about the cardiovascular risks of Contrave. It did recommend that Orexigen should submit post-market data on the matter, if and when it receives full FDA approval.

Currently, the only anti-obesity drug on the market is Orlistat (also known as Xenical and Alli). Recently, Abbott pulled another one, sibutramine (Meridia) after mounting evidence suggested it was associated with strokes and heart attacks.