Aurra | Health News Aggregator

Did your doctor prescribe that expensive drug solely because you need it, or in part because she has friendly feelings toward the pharmaceutical company that makes it, which treated her to a Hawaiian vacation-cum-"medical conference"? Patients may get some insight into such questions thanks to a lesser-known but important provision of the 2010 healthcare reform law that requires the makers of drugs and medical devices to disclose most payments and gifts to physicians.

The proposed regulations, which are going through a period of public comment, are appropriately strict in ways that would both protect patients and reduce medical costs. The payments and gifts would be available on a searchable public website. Free samples of drugs would be exempt from reporting, but otherwise, anything worth more than $10 total for the year would have to be disclosed.

Of course, many doctors are motivated only by the well-being of their patients, and there are times when drug company payments are appropriate and beneficial to medical research. But pharmaceutical companies are known for underwriting luxurious medical meetings for doctors that are more about play than work, and for paying physicians hefty sums to pitch their drugs to colleagues, often at lunches also paid for by the companies. Doctors with the best intentions can be influenced, consciously or not, by relentless marketing, especially when it's done by their peers.

Physicians who received research funding and other payments from pharmaceutical companies have sat on advisory boards for the U.S. Food and Drug Administrationand have recommended drugs made by those companies. A survey published in the Annals of Internal Medicine in 2010 found that 71% of doctors had accepted food from drug companies, and that doctors who took payments were more likely to prescribe those companies' expensive brand-name medications rather than cheaper generics. Fourteen percent of doctors had been paid to serve on advisory boards and enroll patients in clinical trials — and that number was half what it had been in 2004, before the practice came under greater scrutiny. Some drug companies recently began voluntarily reporting payments and gifts to doctors.

In other words, the website will be a force for good even if few patients examine it. Watchdog organizations and news reporters will use it. For many doctors and pharmaceutical companies, the knowledge that their actions will be held up to public light is enough to curb the potentially troubling behavior.

via latimes.com

Posted via email from Jack's posterous

Illinois pharmaceutical company Abbott Laboratories notified 700 employees Wednesday that they will be out of work.

The FDA issued guidance clarifying narrow questions of scientific or generic name placement in ads and labeling in different media, including electronic media.

The latest revision of the Diagnostic and Statistical Manual of Mental Disorders may put an end to classifying bereavement as something other than depression, though it's not clear that will mean much of a bump in the market for antidepressants.

A new fact sheet from the National Institutes of Health explains the A1C test, a widely used and important test to diagnose type 2 diabetes and prediabetes, and to monitor blood glucose levels of people with type 1 and type 2 diabetes.

Momenta Pharmaceuticals ($MNTA) has lost its exclusive hold on the generic Lovenox market--at least temporarily. Amphastar, which has been developing its own version of the Sanofi ($SNY) clot-fighter, persuaded a federal appeals court to stay an injunction against its launch. That means Amphastar and its distribution partner, Watson Pharmaceuticals ($WPI), can sell their drug until and unless the appeal doesn't go its way.

Momenta and its partner, the Novartis ($NVS) generics unit Sandoz, have been marketing their Lovenox copy for months. They've been fighting Amphastar in a patent dispute since Momenta sued last September for infringement. At the end of October, Momenta and Sandoz won an injunction against Amphastar's version. And that's the injunction the appeals court has decided to stay.

So, says Watson in a statement, the two companies will now launch their enoxaparin sodium product "immediately." They have FDA approval for 8 strengths of the drug, and Watson has exclusive rights to distribute the products to U.S. pharmacies.

Momenta's stock dropped by as much as a quarter on the news, but it and Sandoz aren't the only ones that stand to suffer from Watson and Amphastar's launch. Sanofi has benefited from limited competition for its branded version. If the two copycat makers start cutting prices to grab market share, the generics are likely to cut more deeply into the French drugmaker's sales.

- see the press release from Watson
- get more from Bloomberg

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On the Today show this morning, they reported that a whopping 70% of moms in the U.S. say mothering is “incredibly stressful.” On top of that, 96% feel we are far more stressed than our own mothers were. While I can certainly relate (I am a working mom with two kids), I always find reports like that interesting, because I think they can paint a picture of us as martyrs, when in fact, we’re the ones who typically bring this stress upon ourselves. And if we would just cut ourselves some slack, we could probably alleviate a lot of this angst.

Yes, things like the economy, financial insecurities, job losses, family illnesses and caring for aging parents are stressful. There’s no doubt about that. And sometimes those situations leave us little choice in how harried our lives are–at least temporarily. But then there are other stressors that we do choose, like a more intense parenting style, packing too much into our daily agendas, higher expectations for the type of lifestyle we lead and striving for a life of bigger and better that Americans are famous for.

All of this can not only lead to us walking around like over-stressed zombies, but it can be responsible for a decline in our overall health, wellness and happiness–not just for ourselves, but for our spouse and children as well. Chronically stressed moms tend to be more insensitive to their kids (we’re probably all guilty of not looking up from our iPhone on occasion when our kids are trying to tell us something important). Studies also show that a parent’s ability to manage stress is a strong predictor of the quality of her relationship with her children and how happy they are.

To combat this, Today show contributor and psychologist, Michele Borba, prescribed various “mom de-stressors” like giving ourselves a 5-minute “time out”, learning deep breathing techniques, dancing with our kids in the living room, taking time to be spontaneous like baking the dog a birthday cake, and finding a “mommy coach” in a mom chat room. All of which sounds a little, well, ridiculous if you ask me. Not because I don’t think those things could help relieve a little stress (except for baking the dog a cake–isn’t that just adding more to-do’s to our already crazy list?), but because those tactics don’t really get to the heart of the issue. They just give us so-called coping techniques, when what we really need are solve-the-problem techniques.

Which brings me to my point: Outside experts, coaches and even friends are not going to make our stress go away. The only person who can do that is us. It boils down to personal responsibility, in my mind. Meaning, no one is making us live a life of chronic stress. No one is making us work so much just so we can afford a bigger house than we really need. No one says we have to be the class mom, the soccer mom, the PTA chair or the lead volunteer on every community project. No one says we have to spend 24/7 with our kids. In short, no one, except us, is forcing us to be the supermom. The same supermom who is chronically stressed-out, irritable and tired, according to this report.

Ladies, isn’t it time we cut ourselves a bit of slack?

It’s high time we say, screw-it to feeling like we have to do it all and be it all. We don’t have to work so much just so we can buy more things we don’t need. We don’t have to be the go-to volunteer for every school and community project. We don’t have to get all of the chores done every day. And we don’t have to drive our kids here and there and everywhere. We don’t have to be perfect. You get my drift.

Like I said, yes, sometimes there are unfortunate circumstances in our lives that leave us no choice but to pick up a second job or dealing with a family illness, and those are certainly not fun. But what I’m talking about is the rest of our lives, beyond those situations. We are the only ones who can cut down on our stress–not by using some silly coping techniques, but more so by lowering the bars we set for ourselves.

Because, really, we are the only ones who set it so high to begin with.

 

Photo: thinkstock.com

 

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Post from: Blisstree

The National Institutes of Health has launched two multi-site clinical trials to evaluate treatments for out-of-hospital cardiac arrest. One will compare continuous chest compressions (CCC) combined with pause- free rescue breathing to standard cardiopulmonary resuscitation (CPR), which includes a combination of chest compressions and pauses for rescue breathing. The other trial will compare treatment with the drug amiodarone, another drug called lidocaine, or neither medication (a salt-water placebo) in participants with shock-resistant ventricular fibrillation, a condition in which the heart beats chaotically instead of pumping blood.

via well.blogs.nytimes.com

Posted via email from Jack's posterous

Doctors are being told they can no longer sign contracts that contain gagging orders, in new guidance issued by the medical regulator.

The General Medical Council advice states medics should not enter contracts or deals that seek to stop them raising concerns about poor care.

The guidance also makes clear that doctors have a duty to act if they believe care is being compromised.

It is the latest in a series of attempts to encourage whistle-blowing.

Evidence has been emerging in recent years of trusts restricting the ability of staff to raise the alarm about bad practices.

via bbc.co.uk

Posted via email from Jack's posterous

Celgene ($CELG) snapped up Avila Therapeutics and its early-stage Btk inhibitor in a "grand slam" buyout that could hit $925 million with milestone payments. And not to be left out of the day's M&A fervor, Amgen ($AMGN) picked up Micromet ($MITI) for $1.2 billion, citing its "better way to kill tumor cells" as part of the attraction. Article | Report

Does Avastin deserve another look from regulators? Avastin lost its FDA approval for late-stage breast cancer last year after a contentious review, but now two new studies show that it might help women in the early stages of the disease. Both tested Avastin as an add-on to chemo for breast tumors that hadn't spread, and both found that the Avastin patients were more likely to have their cancers disappear.

However, drilling deeper pulls up a few questions. The first study, undertaken in Europe, found that women with "triple-negative" breast cancer--a form of the disease that's aggressive and difficult to treat--responded most strongly to the addition of Avastin. The second study, performed in the U.S., found that women with the triple-negative disease did benefit from Avastin, but patients with hormone-receptor-positive cancer responded best.

As the Los Angeles Times points out, back when the drug's breast-cancer approval was revoked, experts warned that Avastin would likely be found to benefit certain subgroups of patients. Indeed, with that prospect in mind, Roche ($RHHBY) has been digging into the data and testing potential biomarkers that might help identify patients who benefit most from the drug.

The new studies support that subgroups-do-benefit view. But the data isn't cut-and-dried, an American Cancer Society expert told ABC News. "I still don't believe there's a clear message from these studies as to who would benefit and how the medication should be used," deputy chief medical officer Len Lichtenfeld said. And one breast-cancer expert told ABC that worries about side effects remain.

So, should the FDA step back into the Avastin fray? It probably won't do so voluntarily, and Roche certainly has plenty of incentive to submit new data if it's warranted. For now, it looks as if Roche agrees with the folks who decline to draw big conclusions from the latest studies. The new data are "interesting and important," Roche told Bloomberg. "Longer follow-up from these studies is needed before definitive conclusions can be drawn."

In the meantime, perhaps Roche can place its Avastin hopes within its strategy for the company itself: Diagnostics. As Lichtenfeld says, "Frankly, what would help in further understanding Avastin are predictive tests on what type of women would benefit." No doubt the company would agree.

- get the ABC News coverage
- see the LA Times story
- read the analysis from MedPage Today
- check out the Bloomberg piece

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via edrugsearch.com

Posted via email from Jack's posterous

Abbott Laboratories ($ABT) is laying off about 700 workers as part of its ongoing restructuring, the company says, with "several hundred" more facing the ax by year's end. The news comes almost a year to the day after Abbott announced 1,900 job cuts, also part of an ongoing restructuring.

Given that almost every major drugmaker is in the middle of an ongoing restructuring--thanks to the patent cliff, among other pressures--Abbott is in good company. The lion's share of Abbott's cuts, however, fall on its non-pharma businesses. Its stent-making operations in California will lose 300 workers, and its Lake County, IL, diagnostics business will shrink by 200. The remaining 200 layoffs apparently will hit pharma manufacturing in Puerto Rico. No word yet on where the "several hundred" more will fall.

The company tells Crain's Chicago Business the layoff announcement has nothing to do with its biggest restructuring move of all: The plan to spin off its pharma business into a separate, publicly traded company. That plan is proceeding apace, company officials said when announcing earnings yesterday. Like the still-to-come job cuts, the spin-off is expected to happen before the end of 2012.

- read the Dow Jones story
- get more from Crain's
- see the MassDevice piece

Special Report: Abbott Laboratories - Top 10 pharma layoffs of 2011

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The Ranbaxy Laboratories regulatory saga is nearing an end. The Justice Department announced a "groundbreaking" consent decree that requires the Indian drugmaker to make "fundamental changes" to plants in the U.S. and India. The company won't be allowed to sell products made at certain facilities until problems there are corrected. It has to give up its sought-after 180-day exclusivity on three drugs--their identities filed under seal--and perhaps relinquish those rights on three more if it doesn't meet certain milestones.

Part of the reason for such a sweeping decree is Ranbaxy violated one major no-no in drugmaking: It falsified data submitted to the FDA. As part of the deal, Ranbaxy has to set up internal safeguards to make sure fake data doesn't make its way into company filings again. It also has to go back and audit any FDA applications produced by the suspect facilities. If auditors find false data, then those applications must be withdrawn.

The company's quality-control problems were serious, too. The Justice Department cites a lack of proper procedures to prevent contamination of sterile drugs and to keep penicillin meds from contaminating non-penicillin drugs. Ranbaxy also didn't adequately test for drugs' potency or investigate evidence that some drugs didn't meet specifications, the agency said.

"Submitting false data to the FDA in drug applications will not be tolerated," Assistant Attorney General Tony West said in a statement. "The Department of Justice, in partnership with the FDA, will use all available tools, including civil injunction actions and consent decrees, to ensure the integrity of drug applications, and to ensure that all drugs sold in the U.S. meet U.S. standards."

The decree ends more than three years of wrangling over Ranbaxy's manufacturing violations. The FDA announced in December 2008 that U.S. Marshals had seized Ranbaxy shipments and 30 of the company's drugs would be barred from the country. Since then, Ranbaxy has been negotiating with the FDA--and the DoJ has been investigating--in a process that caused considerable nail-biting at Daiichi Sankyo, which bought controlling interest in the Indian drugmaker a short time before the regulatory snafu.

The drama continued as the expiration date on Pfizer's ($PFE) Lipitor patent neared. Ranbaxy had 180-day exclusivity for its version of the drug, but whether it could get FDA approval remained an open question. Rumors flew until the company announced Dec. 1 it had launched its copycat version. The decree won't affect Ranbaxy's Lipitor marketing, officials say. Which is a good thing, considering the company had to set aside $500 million to cover its government settlements.

- read the DoJ release
- get the Ranbaxy statement
- see the story from AFP
- check out the Bloomberg coverage

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After days of rumors, reports now indicate that “whip-its” could have been the drug of choice for Demi Moore and the reason she was rushed to the hospital earlier this week. And here I thought sucking the air out of whipped cream bottles was just for teenagers to do as a cheap and stupid way of getting high when working at Ground Round or Ben & Jerry’s.

Media outlets are now claiming the actress reportedly had a seizure after inhaling nitrous oxide at her home. Known commonly as doing “whip-its,” the activity generally involves inhaling the gas from a whipped cream dispenser for a cheap, quick high, which can produce effect similar to alcohol.

But not all the side-effects from “whip-its” are as simple as that. Adverse reactions can include nausea, dizziness, fainting–and in the case of Moore, a seizure due to a lack of oxygen to the brain. Other reactions can happen over time, such as vitamin B12 deficiencies and negative impacts on DNA and cell growth.

“Whip-its” are usually reserved as a stupid thing that teens do–not someone of Demi’s age and social status. If she was really that stressed-out over her failed marriage with Ashton Kutcher, couldn’t she have just had a few glasses of wine? Surely that would have been a more respectable way to handle things.

Meanwhile, her soon-to-be ex is reportedly partying in Brazil and Demi remains in the hospital.

Photo: nydailynews.com

 

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Post from: Blisstree

Three months ago, Par Pharmaceutical filed a lawsuit against the FDA contending that its right to convey “truthful” information to physicians is protected by the First Amendment, yet is thwarted by agency regulations governing off-label promotion (here is the lawsuit). At issue, the drugmaker argued, was its ability to talk to doctors who may prescribe one of its drugs for unapproved uses.

In particular, Par was referring to Megace ES, which was approved by the FDA in 2005 to treat anorexia, cachexia or unexplained weight loss in AIDS patients. However, Par did not dispute that some doctors prescribe Megace to treat wasting in other patients, such as the elderly or those with cancer. In fact, the US Attorney in New Jersey is investigating its sales and marketing practices.

The lawsuit was the latest missive by the pharmaceutical industry to attack FDA regulations governing drug promotion - notably, off-label marketing - and claim that such efforts constitute protected speech. Drugmakers are testing this argument the wake of a US Supreme Court ruling last year that struck down a Vermont law about data mining (see here).

Earlier this week, however, the FDA filed a response to the Par lawsuit and excoriates the drugmaker for various positions articulated in its complaint. Specifically, the FDA maintains that Par is incorrect to argue that the agency would seek to press off-label marketing charges that would be based on hypothetical arguments, especially if the drugmaker adheres to the law and refrains from such illegal promotion. Put another way, the FDA maintains the case is not ripe.

“This case is not justiciable because Par does not face a credible threat of prosecution for the future course of conduct alleged in the complaint,” the FDA writes. “Par’s argument rests on a patchwork of false assumptions and misinterpretations of the regulations, and if Par confines itself to the marketing plans and activities specifically alleged in the complaint, it has no reason to fear prosecution on that basis… Par cannot fabricate a justiciable controversy by wrongly anticipating agency action based on a misreading of FDA’s regulations and claiming a need to assuage self-induced
fears.”

Not surprisingly, the FDA also argues that Par is fundamentally wrong to insist its ability to discuss its drugs is crimped - if off-label promotion occurs. “The challenged FDA regulations are fully consistent with the Federal Food, Drug, and Cosmetic Act and the First Amendment, and leave ample room for Par to engage in truthful and non-misleading speech about the approved use of its product,” the FDA continues. “Whatever interests Par may assert are far outweighed by the government’s paramount interests of protecting the public health by ensuring the safety and effectiveness of drugs for their intended uses.” In short, off-label promotion stands as a justifiable reason for prosecution.

But there is more. The FDA then argues that Par brought its lawsuit in a not-so-veiled attempt to derail and undermine the investigation by the US Attorney. As the agency notes, Megace ES has been approved since 2005, but Par never followed-up its own efforts to seek additional indications for the drug, which might have allowed for marketing to cancer or geriatric patients.

To make that point clear, the FDA attached a declaration to its brief from Rachel Sherman, the associate director of medical policy and director of the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, along with minutes from various meetings in 2005 between Par and the agency in which suggestions were made for reworking a clinical trial to gain wider approval (here is the FDA brief).

Meanwhile, the FDA also notes in its brief, that Par has admitted to speaking about approved uses to “potentially off-label prescribers” in certain settings, including oncology and long-term care facilities for the elderly. And at the same time, the agency points out that Par maintains that its reps do not speak about approved use to off-label prescribers in settings targeting elderly or cancer patients.

“But there is no principled distinction to be made between these activities in these two settings,” the agency argues. “Whatever Par’s reasons for choosing to promote in one setting but not the other, it was not chilled by a fear of prosecution, and Par’s alleged harm is self-inflicted and unnecessary. Nor has Par explained why, if its fear is real and its motivation is to clarify its First Amendment rights, it waited until this late hour to file suit - after marketing Megace ES for six years, and without any intervening change in the governing regulations or FDA’s statements about how it interprets them.”

In short, the FDA is arguing that Par acted prematurely and is using the newly emerged debate over off-label promotion and protected free speech to avoid the threat of criminal prosecution. “If and when that investigation leads to any enforcement action against Par, the government’s case will rest on the full range of evidence regarding Par’s past conduct that has been developed in that investigation. Par will be free to assert any constitutional defenses to such an enforcement action in the course of that proceeding.”

One regulatory expert says the scenario is reminiscent of a case involving Allergan, which paid $375 million and pleaded guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses. The drugmaker also paid $225 million in fines to cover civil claims asserted by the DOJ under the False Claims Act (back story).

As part of the deal, however, Allergan was required to dismiss its First Amendment lawsuit (here it is) in which the drugmaker sought to win the right to distribute information about unapproved uses for Botox in the context of providing scientific and medical info to doctors. Allergan claimed an FDA ban on off-label marketing violated its First Amendment rights to free speech.

“I see this in much the same way as the Allergen lawsuit,” says Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer. “I always thought that case was an effort to gain leverage in the negotiations. Allergan paid $600 million, but it’s hard to know if the lawsuit actually made a difference.

“In any event, I think the government has done a very effective job (in the Par brief) of saying ‘Look, whatever is going on in that investigation is all well and good, but that’s not what this case is about.’ And, according to FDA, it’s not a ‘case or controversy’, in any event, because what Par is saying it wants to do is not a violation of law. According to FDA, if all that the company wants do is what it lays out in its complaint, then that’s not a problem by itself. But if there’s some other scheme we don’t know about, then FDA, according to the brief, reserves the right to examine that separately. But based on what’s in the Par Complaint, FDA says it won’t prosecute. So what’s the big deal?”

“I think government is right on this point. I think this is an effort by Par to gain leverage in the DOJ investigation. On the other hand, I think the government makes a very strong case that there’s no controversy here… As FDA notes, if Par is shivering because it perceives a ‘chill’ in its First Amendment rights, that shivering is for its own reason, but not because Par risks any appreciable danger of prosecution for the limited activities in lays out in its complaint.”

pic thx to newtown graffiti on flickr

Bristol-Myers Squibb's ($BMY) earnings didn't reach the Wall Street goalposts, partly because of higher costs, some of them attributed to U.S. healthcare reforms. Sales of its flagship drug, Plavix, actually fell 3% to $1.67 billion for the fourth quarter. Blood-pressure remedies Avapro and Avalide slid 23%. And the drugmaker predicted a drop in 2012 earnings, thanks to generic competition.

Still, the numbers hinted at a rosier future for the U.S.-based company, known for its "string of pearls" acquisition strategy and tight focus on branded pharma. "Our delivery of several new products to patients, the ability of our productive R&D organization to build an innovative and diverse pipeline, and our continued commitment to business development gives us confidence in our future," CEO Lamberto Andreotti said in a statement.

Sales of newer drugs delivered significant gains, Bloomberg points out, with the leukemia drug Sprycel expanding 34% to $227 million and revenues from Onglyza, a diabetes pill, more than doubled to $153 million. The brand new melanoma drug Yervoy pulled in $144 million for the quarter. Abilify, the antipsychotic drug, grew 4% to $737 million.

Bristol-Myers has exclusivity on Sprycel and Onglyza till at least 2020. Its marketing contract on Abilify was extended through 2015. Plavix and Avapro go off patent this year. So, it's the newer meds on their way up this quarter, with aging drugs on the decline. As Deutsche Bank's Barbara Ryan told Bloomberg: "This is a new product story, and the product performance in the quarter was quite good."

- read the Bloomberg piece
- get more from The Wall Street Journal

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Asian women who consumed an average of 200 milligrams or more of caffeine a day -- the equivalent of roughly two cups of coffee -- had elevated estrogen levels when compared to women who consumed less, according to a study of reproductive age women by researchers at the National Institutes of Health and other institutions.