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 Drugs.com is proud to introduce the most comprehensive directory of medical conferences. As a healthcare professional, you can find detailed information for both current and upcoming events related to your field of expertise. Direct links to the organizer's website make it quick and easy to access additional information on how to attend or register for a specific event.

 

 Pfizer’s Pristiq Demonstrates Low Potential For Sexual Dysfunction in Adults with Major Depressive Disorder

October 29, 2014 - Pfizer Inc. today announced the publication of a clinical study in the Journal of Clinical Psychiatry showing comparable sexual function in adult patients diagnosed with major depressive disorder (MDD) treated daily with Pristiq (desvenlafaxine) Extended Release Tablets 50mg and 100mg doses versus placebo. Sexual dysfunction is often an issue for patients treated with antidepressants, and Pfizer conducted the study pursuant to a postmarketing requirement by the U.S. Food and Drug Administration (FDA).
“Sexual dysfunction is a common concern for patients treated with antidepressants. This study showed that sexual function was comparable between desvenlafaxine and placebo,” said Dr. Anita Clayton, interim chair, Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia Health System, and lead investigator of the study. “The low potential for sexual dysfunction with desvenlafaxine is encouraging, and physicians and patients would benefit from further study.”
The primary end point of the study showed a statistically significant improvement among patients treated with Pristiq compared to placebo in symptoms of major depressive disorder as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score over an 8-week period. The HAM-D17 is a validated assessment tool used to rate the severity of a patient’s depressive symptoms. Sexual dysfunction was a secondary end point, and measured using the Arizona Sexual Experiences Scale (ASEX), a validated and reliable patient rated sexual function scale in the United States.
An estimated 33 million to 35 million U.S. adults are likely to experience major depression at some point during their lifetime. The criteria for MDD include having five or more of the symptoms of depression listed below during the same two-week period and representing a change from previous functioning. Depressed mood or diminished interest or pleasure must be among the depression symptoms reported from the following list: depressed mood; diminished interest or pleasure; significant weight loss or change in appetite; insomnia/hypersomnia; psychomotor agitation; fatigue or loss of energy; feelings of worthlessness or excessive/inappropriate guilt; difficulty concentrating; and recurrent thoughts of death.
In this Phase 4, multi-center, randomized, double- blind placebo-controlled study, a total of 924 patients, 18-years or older, with a baseline HAM-D17 score of ≥20, were randomly assigned to Pristiq 50mg/day, Pristiq 100 mg/day or placebo in a 1:1:1 ratio over an 8-week period. The primary efficacy end point for the study was the change from baseline in HAM-D17 total score at week 8. In the primary efficacy analysis, a statistically greater change from baseline was observed in patients receiving Pristiq 50 mg and Pristiq 100mg compared with placebo. The most common treatment emergent adverse events observed were consistent with the known safety and tolerability profile of Pristiq.
Sexual function was assessed using the ASEX Scale. The ASEX was selected over other validated scales because it is a brief but sensitive tool, less burdensome to patients than a more in-depth scale, and has been utilized in previous trials for desvenlafaxine and other antidepressant drugs. It measures five core elements of sexual function (sexual drive, arousal, penile erection/vaginal lubrication, ability to reach orgasm, and satisfaction from orgasm) rated on a six-point Likert scale. A Likert scale is a psychometric scale commonly utilized in research that employs questionnaires. A total score is calculated as the sum of all 5 individual item scores; negative numbers for change from baseline indicate improvement in sexual function.
Incidence of sexual dysfunction was assessed using the ASEX data. In adult outpatients with MDD with baseline sexual activity and at least one post-baseline assessment, effects on ASEX total and item scores were comparable for the Pristiq 50 mg and Pristiq 100 mg groups and placebo. Rates of sexual dysfunction were comparable between each Pristiq dose and placebo at baseline (placebo, 52%; Pristiq 50 mg/d, 56%; Pristiq 100 mg/d, 54%) and at week 8 (placebo, 45%; Pristiq 50 mg/d, 49%; Pristiq 100 mg/d, 47%).
“The treatment and management of MDD in adults can be both complex and challenging for physicians and patients,” noted Dr. Salomon Azoulay, global clinical and medical affairs head, Pfizer Global Established Pharma. “As a science-based company, we continue to study Pristiq in order to provide clinicians with information that can help guide their treatment decisions and positive health outcomes for patients with MDD.”

About Pristiq (desvenlafaxine)

Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is a prescription medication that was approved by the U.S. Food and Drug Administration (FDA) in 2008 for the treatment of MDD in adults. The recommended dose for Pristiq is 50 mg once daily, with or without food. In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.

Pfizer Inc.: Working Together for a Healthier World®

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
Source: Pfizer Inc.
Posted: October 2014

  Nearly half million apply for U.S. health insurance despite flaws: officials

(Reuters) - Roughly half a million Americans have applied for health insurance through new federal- and state-run exchanges under President Barack Obama's signature healthcare law, an administration official said on Saturday.
That figure comes as problems with the federal marketplace's entry portal serving 36 states, the website Healthcare.gov, have thwarted consumers from shopping for federally subsidized health coverage and drawn derision from Republicans, who oppose the law, popularly known as Obamacare.
The acknowledgement of the number of applicants, late on a weekend evening, appeared to be part of a ramped-up damage control effort by the White House.
Obama's Patient Protection and Affordable Care Act is expected to provide private health coverage to an estimated 7 million uninsured Americans through the new online marketplaces that opened for enrollment in all 50 states on October 1.
But the Healthcare.gov website was hobbled by technical issues - including error messages, garbled text and delays loading pages - that administration officials blame partly on an unexpectedly high volume of 14.6 million visitors in its first several days of activity.
Obama is frustrated by the poor start and told advisers during a recent Oval Office meeting that the administration had to take responsibility for not having the site ready on time, an official said.
"The website is unacceptable, and we are improving it, but the product is good and across the country people are getting access to affordable care starting January 1," one administration official said.
"We are going to work intensely for the next six months to make sure we meet the demand."
Another administration official said that among the roughly half a million applicants, more than half lived in states where the federal government was administering the health exchanges in full or in part.
Official figures from October activity are not due until next month.
Obama is holding a healthcare-themed event at the White House on Monday and will likely address the problems.
Members of his administration plan to travel the country to encourage people in areas with high levels of the uninsured to apply, an official said, and call centers were getting more staff to deal with phone calls from applicants who have trouble getting through online.
As Washington moves on from a 16-day government shutdown that concluded this week, Republicans are also turning up the heat on the administration to address the program's problems. Republicans in the House of Representatives triggered the government shutdown in a failed attempt to defund or delay Obamacare.
Republicans have criticized Health and Human Services Secretary Kathleen Sebelius for declining to appear before an oversight panel to discuss the issue on October 24.
(Additional reporting by David Morgan; Editing by Peter Cooney and Eric Walsh)

Data center glitch is latest problem in 'Obamacare' rollout

(Reuters) - A data center critical for allowing uninsured Americans to buy health coverage under President Barack Obama's healthcare law went down on Sunday, halting online enrollment for all 50 states in the latest problem to hit the program's troubled rollout.
The data center operated by Verizon's Terremark experienced a connectivity issue that caused it to shut down, affecting the federal government's already problem-plagued online marketplace Healthcare.gov and similar sites operated by 14 states and the District of Columbia, according to the U.S. Department of Health and Human Services (HHS).
Obama administration and company officials could not say how long it would take to fix the connectivity problem.
Separate technical problems that have stalled enrollment on Healthcare.gov since its launch on October 1 are at the heart of a new Republican effort to discredit the healthcare law, also known as Obamacare, largely through congressional investigations to determine what went wrong in building the costly and complicated implementation system.
Health and Human Services Secretary Kathleen Sebelius is due to testify later this week before a House of Representatives committee, while government contractors work around the clock to improve the Healthcare.gov website.
The outage that started in the early hours of Sunday caused the data center to lose network connectivity with the federal government's data services hub, an electronic traffic roundabout that links the online health insurance marketplaces with numerous federal agencies and can verify people's identity, citizenship, and other facts.
Without the hub, consumers are unable to apply online for coverage or determine their eligibility for federal subsidies to help pay for insurance premiums. On Saturday, Sebelius praised the hub's ability to perform complex calculations in quick time as an example of a successful segment of the system.
HHS spokeswoman Joanne Peters said Sebelius spoke with Verizon's chief executive officer on Sunday afternoon to discuss the situation: "They committed to fixing the problem as soon as possible."
The outage was affecting enrollment in all 50 states, as well as Terremark customers not connected with the marketplaces, according to the HHS spokeswoman. She said the data center's network connectivity went down during planned maintenance to replace a failed networking component.
A spokesman for Verizon said the problem would be fixed "as soon as possible."
"Our engineers have been working with HHS and other technology companies to identify and address the root cause of the issue," Verizon spokesman Jeff Nelson said.
The administration has expressed confidence it can fix underlying problems with Healthcare.gov by early December, in time for people to meet a December 15 deadline to enroll in new health plans to receive benefits on January 1. Further delays would jeopardize its ability to enroll as many as 7 million Americans for coverage during Obamacare's first year.
Sebelius, who faces Republican calls for her resignation, will be grilled about her role in the Obamacare rollout on Wednesday before the House Energy and Commerce Committee.
Contractors have already blamed the administration for not conducting enough vital system-wide testing and for a last-minute design change requiring online visitors to set up accounts before window-shopping for insurance. The change is widely blamed for creating early bottlenecks as millions of people flooded the website.
Health officials in Connecticut, one of the 14 states that constructed their own marketplaces, were the first to report on Sunday that potential customers would not be able to complete the sign-up process for some services but could create accounts and search for pricing comparisons.
The Centers for Medicare and Medicaid Services, the HHS agency responsible for the federal system, told Connecticut officials about the outage and gave no indication of when the data services hub would be functioning again, said a spokeswoman for Access Health CT, the Connecticut exchange.
(Additional reporting by Anna Yukhananov and Emily Stephenson in Washington; Editing by Michele Gershberg, Will Dunham and Paul Simao)

Why 'Rate Shock' Is An Essential Part Of Health Care Reform

Once Obamacare is implemented, America's health insurance system will be a thicket of subsidies and transfers that benefit some people and harm others. Critics of the law have seized on this observation, noting the existence of "rate shock": some people (especially young and healthy ones with moderate and high incomes who buy insurance in the individual market) will pay more than they used to, so others can pay less.
But here's the thing: Before Obamacare, our health insurance system was already a thicket of subsidies and transfers. The law doesn't simplify the system, but it does make the thicket of subsidies and transfers more sensible: directed more at people who have low incomes or high health needs, and greatly shrinking the share of the population that doesn't have health coverage at all.
Making the thicket more sensible will mean that some people's costs go up, producing "rate shock."
Take a look, for example, at Sen. Ted Cruz (R-Texas). Cruz has frequently noted that he declines the health plan that is offered to him as a member of Congress. Instead, he is covered through insurance that his wife gets as a Managing Director at Goldman Sachs.
Health care economist Austin Frakt ran the numbers on that Goldman plan. As of 2009, Goldman's health insurance coverage for employees at the managing director level and higher cost a stunning $40,000 per family. (The typical cost for a family health insurance plan in the United States is around $16,000).
Health insurance benefits are not taxable income, so Cruz and his wife get a big tax break on that plan. The break cut their tax bill by about $15,000 as of 2009, the last year for which we know the plan's value. The Cruzes aren't alone; every American who gets health insurance coverage through work gets this tax break, but the Cruzes enjoy an especially large one because their plan is so expensive and their tax rate is high.
For comparison, Medicaid coverage for two adults and two children cost about $11,000 in 2010, meaning (unless Goldman has radically changed its health benefits since 2009) Cruz is getting a tax break worth more than the benefits a family on Medicaid gets — even though he is a Senator and his wife is a highly paid investment banker and they have no need for subsidies to obtain health coverage.
This is insane health policy, and the Affordable Care Act changes it.
Starting in 2018, the law will impose a "Cadillac Tax" on high-cost health plans of the sort the Cruz family enjoys. The 40% tax on the portion of family plan premiums exceeding $27,500 will serve partly to raise revenue by offsetting the income tax exclusion for insurance. It will also encourage firms like Goldman to offer less-generous plans (which will reduce upward pressure on health care prices) and pay more of their employees' compensation as taxable salaries (producing additional new revenue).
Those new revenues will be spent on things like expanding Medicaid and offering subsidies to low- and moderate-income Americans who buy health plans in the Obamacare exchanges: that is, people who actually need financial assistance to get health coverage. And the Cruzes will still be enjoying a big subsidy since the first $27,500 of their health benefits will be shielded from tax.
Not everyone who will lose out on benefits is in as unsympathetic a position as Cruz. Yesterday, the Los Angeles Times looked at how many Californians who currently get health insurance through the individual market are facing higher premiums. But here's the most important part of the article:

A number of factors are driving up rates. In a report this year, consultants hired by the state said the influx of sicker patients as a result of guaranteed coverage was the biggest single reason for higher premiums. Bob Cosway, a principal and consulting actuary at Milliman Inc. in San Diego, estimated that the average individual premium in 2014 will rise 27% because of that difference alone.

It's a lot cheaper to provide health insurance coverage if you exclude a lot of the people who need it most. Making insurance available to people with pre-existing health conditions costs money. Obamacare funds this transfer to the chronically ill in part by raising premiums on healthy people.
There are other ways this transfer could have been funded. For example, we could have a single payer health care system. That would provide disproportionate benefit to people with chronic illness, and it would be funded with some sort of broad-based taxation, almost certainly meaning people with higher incomes would pay the lion's share of the cost.
I don't think conservatives would like that solution, or other solutions that have the government directly take on the cost of insuring the chronically ill. Republicans in the House of Representatives have shown no enthusiasm for high-risk pool plans, sometimes touted by conservative health wonks, which would use government subsidies to provide care to people with expensive chronic conditions who get left behind by current insurance markets.
In the absence of a direct subsidy approach, Obamacare's cross-subsidy approach is a pretty good way to get care to people who need it.
Some healthy people are facing premium increases above and beyond the cost of making coverage available despite pre-existing conditions. The Times further notes:

Individual policies must also cover a higher percentage of overall medical costs and include 10 "essential health benefits," such as prescription drugs and mental health services. The aim is to fill gaps in coverage and provide consumers more peace of mind. But those expanded benefits have to be paid for with higher premiums.

Again, this is just a transfer. Healthy adult women have higher medical costs than healthy adult men. Mandating coverage for things like materinty and contraception, and mandating that premiums not vary based on sex, provides a transfer from men to women to adjust for that fact. Is that fair? I think it's reasonably fair.
The Times continues:

The federal law also adjusts how rates are set by age, a change that gives older consumers a break and shifts more costs to younger people. Rates by age can vary by only 3 to 1 starting next year as opposed to 6 to 1 in some cases now in California. People in their 20s just starting their careers may earn so little they qualify for subsidies. But that might not be the case for consumers who are slightly older and earning more.

"It has the effect of benefiting people in their 50s and 60s and shifting costs to people in their 20s and 30s," said Patrick Johnston, president of the California Assn. of Health Plans. "Benefits are being increased for all, but it's not government subsidies for all. Some will pay more."

This, I think, is the most assailable part of the cross-subsidies in Obamacare. The young are being asked to subsidize the old. It would have been better not to cap premium variation on the basis of age, and rely on Obamacare's exchange subsidies to keep insurance affordable to older people with lower incomes. If you're a high-income person in your 50s, you could be expected to pay for the fact that a 50-year-old is more expensive to insure than a 35-year-old.
The new system of subsidies and cross subsidies that Obamacare sets up is far from perfect. But perfect is not on the table. The question is "is it better than the old system, where huge subsidies go to people with no need for them and tens of millions are left uninsured?" That answer, if you consider the costs and benefits honestly, is yes.
But conservatives don't do that.
For the last few weeks, I have seen a vast outpouring of conservative sympathy for young, healthy, prosperous people whose health plan premiums are going up. These poor, poor things. How could Barack Obama do this to them?
It's true that some of these people are worse off. Others are getting major offsetting benefits; Kevin Drum notes that one woman who complained to the Los Angeles Times about her rising premiums is pregnant and likely to see big near-term returns from her more comprehensive plan.
But what about the tens of millions of Americans who currently lack health insurance and are about to get access to available, affordable coverage? Where is the conservative sympathy for people who would be worse off if the law doesn't go forward?
Nowhere. Because for all the needless complexity of liberals' approach to improving health insurance and helping the sick, conservatives don't have one at all.

Attack ads signal health-care fight will be key issue in 2014 elections

 

A new Republican attack ad playing on Arizona radio is an early sign that the Affordable Care Act will be fought over yet again during the 2014 elections.
The ad, which is shaky on some facts, targets U.S. Rep. Ann Kirkpatrick of Arizona and other Democrats across the country, but it could also hurt two of Kirpatrick’s GOP challengers.
The National Republican Congressional Committee claims in the radio ads that members of Congress gave themselves special treatment under President Barack Obama’s health-care law.
“Kirkpatrick voted to keep special subsidies for members of Congress,” says a woman in the ad, which runs until Tuesday. “Kirkpatrick is using our tax dollars to fund her health-care benefits.”
Although parts of the claim are accurate, independent fact checkers and even some conservative media outlets have dismissed the overall argument by Republicans: that it’s unfair for members of Congress and their staffers to receive federal subsidies for their health care if some Americans don’t.
Despite it being signed into law more than three years ago, the Affordable Care Act has continued to be a staple of political campaigns during the past two election cycles.
This time, it appears Republicans plan to highlight questions of fairness and problems with implementation of the law, including the troubled healthcare.gov website where people sign up for coverage.
Democrats plan to tout the benefits of the law, including coverage for people who are currently uninsured and those with pre-existing medical conditions.
Members of Congress and their staffers have traditionally received medical insurance from the federal government as part of their compensation and at a fraction of its cost. It’s the same arrangement federal employees have, as well as the millions of private workers whose employers cover some of their health-insurance costs.
That’s about to change, however, for members of Congress and their staffers who, by next year, will no longer receive federal employee health-care coverage. Under a Republican-backed proposal included in the Affordable Care Act, they will have to purchase coverage through the new health-insurance marketplaces where uninsured people are supposed to buy coverage under the law.
That provision aims to force Washington decision-makers to go through the same experience uninsured Americans will go through when they sign up for coverage under the law — that is to say, a frustrating experience, given recent problems with the healthcare.gov website. But the provision did not specify what would happen to the costs of covering those federal employees typically paid for by the federal government.
The Obama administration decided earlier this year that those subsidies would continue. Otherwise, members of Congress and their staffers would, in effect, face a significant salary cut.
The NRCC says that’s unfair because uninsured Americans who purchase coverage on the exchanges won’t receive similar subsidies — although low-income people will receive help.
Kirkpatrick joined fellow Democrats in voting last month against requiring lawmakers and their staff members to pay the full cost of their insurance. The legislation passed the House but failed in the Senate.
“The employer contribution is a continuation of the same formula used for all federal employees who receive health coverage,” said Jennifer Johnson, a Kirkpatrick spokeswoman. “They are the same for a park ranger at the Grand Canyon, a nurse at a Veterans Affairs clinic or a constituent caseworker in a congressional office.”
Adam Kwasman, a Republican looking to unseat Kirkpatrick, said it is “insulting” that members of Congress and their staffers receive federal subsidies on the exchange.
“I think it’s the height of hubris to believe the American people would not be furious with the fact Washington gets benefits that good, old-fashioned, hardworking taxpayers don’t get,” he said. “I don’t believe in subsidization of the elected class. It’s horrible.”
But Kwasman, along with Republican candidate Andy Tobin, is eligible for a nearly identical “handout” as a state lawmaker. They can sign up for health-insurance plans, subsidized by Arizona taxpayers, that are provided to state employees.
The most popular medical and dental plan costs lawmakers covering their family a yearly premium of about $4,000, according to the Arizona State Senate Accounting Office. The state subsidizes that coverage with about $17,000 per year.
When asked about receiving subsidized health insurance as a state lawmaker, Kwasman said he would “look into changing that rule.”
Tobin did not return requests for comment.
Arizona political scientist Bruce Merrill said most voters won’t take the time to tease out the details of such accusations and whether they ring of hypocrisy, given two of the Republicans in the race are eligible to receive taxpayer-subsidized coverage. Instead, the GOP message of the subsidy’s unfairness is likely to resonate, reinforced by years of reporting on congressional perks.
He also said the NRCC’s strategy makes sense as a response to criticism the GOP has taken over hurting “the little guy” with its role in the partial government shutdown.
“It’s obviously an attempt ... to say, ‘We do care about the average American,’ ” he said.