Monday, November 30, 2009

Should Drug Companies Carry Out Their Own Clinical Trials?

Two experts question on today whether the conflict of interest is unethical when drug companies perform clinical trials on their own medicines.

Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.

Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.


Sunday, November 29, 2009

Patient advocates ill at ease with Rx data mining Patient advocates see sales tactic as medical meddling

When your doctor writes you a prescription, that's just between you, your doctor and maybe your health insurance company, right?

Wrong. The pharmaceutical companies that make those prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for which drugs the physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, health care advocates and legal authorities.

The identity of patients is not disclosed, but knowing in detail what doctors are prescribing enables drugmakers to fine-tune their messages when sales reps call on doctors. They can lobby for use of an alternative drug made by their own company, for instance, bolstering the pitch with specially selected research data or free samples.

What worries some government officials and patient advocates is that sales tactics keyed to a doctor's prescribing preferences may distort decision-making. That's especially likely, the critics say, when many doctors have trouble finding time to examine a plethora of studies and weigh the results carefully. And, given the concern over costs, they say, free samples or other inducements could influence decisions for nonmedical reasons.

The practice is known as "prescription data mining." Medical data firms annually blend several billion prescription records -- purchased from pharmacies and health insurers -- with physician data from the American Medical Association and other sources and sell the results to drug companies.


Friday, November 27, 2009

Focus on Pharmacotherapy Studies in Elderly

The NIMH-sponsored New Clinical Drugs Evaluation Unit (NCDEU) meeting is a favored venue for reports and reviews of NIH-funded psychopharmacological studies, and this was true of the recent annual meeting in Hollywood, Fla. The meeting included a workshop on new investigations of antidepressant use in Alzheimer disease and a panel session on the safety of pharmacotherapy in older adults.

Two studies were developed, in part, in response to growing concern about both safety and lack of efficacy of antipsychotics for behavior symptoms in patients with dementia. These were the Depression in Alzheimer’s Disease Study–2 (DIADS-2) sertraline (Zoloft) trial, the citalopram (Celexa) versus antipsychotics nested study in the Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer’s Disease (CATIE-AD), and the recently initiated Citalopram for Agitation in Alzheimer’s Disease (CITAD).

In describing the rationale and design of the CITAD study, Bruce Pollock, MD, Center for Addiction and Mental Health, questioned the premise for using antipsychotics in this population. “The neuropharmacologic rationale for using dopamine antagonists in elders with dopaminergic deficits is questionable,” Pollock indicated. “Agitation in Alzheimer disease is commonly derived from anxious, impulsive, and compulsive symptoms, which may be responsive to serotonergic agents.”


Thursday, November 26, 2009

'Doctors should stop pushing drugs at depressed people'

Despite a large increase in cognitive behaviour therapy (CBT) doctors are still pushing drugs at patients, according to Dr Jennifer Wild, a senior lecturer at the Institute of Psychiatry.
In this week's Scrubbing Up, she argues that GPs need to understand that psychological therapies like CBT work and should choose to offer them.

People with depression often get better when they change the way they think.
Since therapy is more likely to achieve this with longer-lasting results than drugs, doctors need to stop pushing pills and start pushing treatments that work.

Depressed people feel low, worthless, and often suicidal. They need treatment.
Six million people suffer from depression and anxiety in the UK, and surveys show that most do not want to take drugs.

They want a treatment with long-lasting results.


'Distorted thinking'

This treatment is cognitive behavioural therapy (CBT).
CBT is based on a well-supported theory of how depression starts and what keeps it going: distorted thinking patterns.
Change people's thoughts and recovery occurs.

Wednesday, November 25, 2009

Ziprasidone Okayed for Bipolar Disorder

The FDA has cleared ziprasidone (Geodon) for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

It joins several other antipsychotic drugs -- including quetiapine (Seroquel), aripiprazole (Abilify), and olanzapine (Zyprexa) -- approved for this indication.

Ziprasidone is also approved for acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for schizophrenia.

The approval as bipolar maintenance therapy follows a a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder, according to the drug's manufacturer, Pfizer.


Tuesday, November 24, 2009

Psychiatrist Helped Demonstrate Psychotherapy Is Cost-Effective

Whether psychotherapy is cost-effective was an important question during President Clinton's health care reform effort. Lessons from that era remain relevant during current health reform debates.

If psychotherapy has a place in the American health care system of tomorrow, give some credit to psychiatrist Susan Lazar, M.D., and other clinician-researchers who helped establish the evidence base for the cost-effectiveness of psychotherapy beginning more than 16 years ago.

That was when Hillary Rodham Clinton's Health Care Task Force was at work. Though the exact content of health insurance benefit packages hasn't yet been a focus of today's health care debates, a decade and a half ago task force members were weighing the relative value of any health care service as a criterion for inclusion in mandated benefits.

And “value” meant cost-effectiveness—the cost of providing the service compared with the benefits derived from the service.


Monday, November 23, 2009

Psychotropic Drugs Boost Fall Risk in the Elderly

A new analysis of studies including nearly 80,000 people aged 60 and older confirms that certain types of widely prescribed drugs, such as antidepressants and sedatives, can increase their risk of falling.

Falls often have serious consequences for older people, such as injuries leading to disability and admission to a nursing home, or even death.

While prescription drugs are recognized as contributing to fall risk among older people --who are likely to be on lots of medications -- discovering just which drugs are the problem is still a "challenge," Dr. Carlo A. Marra of the University of British Columbia in Vancouver and colleagues note in the Archives of Internal Medicine.

To update a review of studies on this subject published in 1996, Marra and his team identified 22 studies published between 1996 and 2007 including 79,081 people 60 and older, some of whom lived independently, and some of whom were institutionalized. They analyzed the risk of falling associated with nine classes of drugs.

Three classes turned out to significantly boost fall risk: sedatives and hypnotics, typically prescribed as sleeping aids; antidepressants; and benzodiazepines, which include tranquilizers like Xanax and Valium.


Sunday, November 22, 2009

The stigma of mental illness The suicides of a German footballer and two of my colleagues show how destructive is the stigma of psychiatric ill-health

Last week's suicide of the German goalkeeper Robert Enke revealed more than the terrible news of one man's death, the cruelty of depression and the pressures on sportsmen to protect the public's idealised view of them; it also exposed the ongoing shame and stigma of mental illness. For years he had been struggling with depression, kept secret from the public and his colleagues for fear of a vicious backlash that could, he apparently feared, raise questions about his capacity to care for his adopted baby girl and play for his nation.

Rather than risk this, and perhaps further despairing under the force of these private terrors, he chose the solution of death. That this seemed preferable to risking public awareness of his depression and the imagined consequences of personal shame, family destruction and exclusion from his nation's crucial sporting event, demonstrates something of the huge level of hatred that mental illness still evokes in the public imagination. The stigma only worsens the burden on those with mental health problems, typically reported as one in four of the adult population in the UK.

When people die by their own hand, a response of shocked disbelief, of the sense of an awful secret that has been starkly exposed, occurs all too often. How is it in this advanced age of emotional literacy, psychological self-help and media shrinks that the shame of depression and other mental illness causes people to desperately try to hide their problems rather than challenge society to accept that they, like so many others, are vulnerable?


Saturday, November 21, 2009

Healthcare lobby set for record spending this year

It's not just spending on U.S. healthcare that is breaking records. Drugmakers, insurers and industry groups are on track to spend an all-time high of more than $500 million this year to influence Congress' revamp of the healthcare system.

Lobbyists for the healthcare sector will likely smash previous spending records by tens of millions of dollars this year as Democratic lawmakers try to reshape the industry by expanding coverage and shaving costs.

"If current trends continue, the health sector is likely to spend more than a half-billion dollars on lobbying in 2009," said The New England Journal of Medicine's Dr. Robert Steinbrook.

As Congress makes a final push for a bill to overhaul the $2.5 trillion healthcare system that fuels one-sixth of the U.S. economy, health companies and industry groups are trying to shape the outcome.


Friday, November 20, 2009

Rising Prices of Drugs Lead to Call for Inquiry

Democrats in Congress asked for two separate investigations of drug industry pricing Wednesday as they continue working on legislation to overhaul the nation’s health care system.

Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices.

Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry’s concerns about future cost containment under any health care legislation.

“Recent studies have indicated that the industry may be artificially raising prices for certain pharmaceutical products in expectation of new reforms,” the House Democrats wrote in a letter to the Government Accountability Office, a nonpartisan investigative arm of Congress. “Any price gouging is unacceptable, but anticipatory price gouging is especially offensive,” the letter added, asking the G.A.O. to conduct an expedited review of the price increases.


Thursday, November 19, 2009

US Army suicides on track to hit new high in 2009

US Army is short on mental health professionals as it tries to stem rising number of Army suicides.

The US Army is short as many as 300 substance-abuse counselors and 800 mental health professionals as it attempts to stem the rise of soldier suicides, which is expected to break new records again this year.

As of Monday, there were 140 confirmed suicides in 2009 among the active-duty Army and another 71 from the Reserve and National Guard, said Army Gen. Pete Chiarelli, the service's vice-chief of staff. This year will probably be worse than last year, in which 140 suicides were confirmed, he said. That would represent the fifth straight year suicides increased in the Army.

"This is horrible, and I do not want to downplay the significance of this in any way," said Chiarelli, noting that the rising number of suicides is probably the "toughest challenge" he's ever had to tackle.

The Marine Corps is seeing a similar trend: Last year it confirmed 42 suicides and has counted 42 already this year.

Too few mental health experts are available to address the problem – reflecting a shortage of such experts across the country, not just in the military.


Wednesday, November 18, 2009

Drug ads get scrutiny from the FDA

When patients are diagnosed with an illness, the Web is fast becoming the first place they look for information, treatment options and support groups.

Drug companies want to be part of that conversation. But they are wary of advertising online because of the Food and Drug Adminstration's vague rules about ad content and disclaimer information for Internet marketing. Afraid of violating those rules, most pharmaceutical makers have shied away from advertising specific products online, instead relying on traditional media such as TV and print ads, for which there are strict guidelines.

The online advertising industry says the lack of clarity around the rules is costing millions in potential ad revenue and is actually resulting in less information getting to consumers.

The FDA is hosting a two-day workshop, which concludes today, to discuss how drug companies should be allowed to advertise on Web sites, search engines and social media sites. (The Wall Street Journal and NPR both wrote stories on the workshop.)


Tuesday, November 17, 2009

Medical Schools Quizzed on Ghostwriting

Senator Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students.

Mr. Grassley, of Iowa, the ranking Republican on the Senate Finance Committee, sent the letters as part of his continuing investigation of so-called medical ghostwriting. The term refers to publication of medical journal articles in which an outside writer — sometimes paid by a drug or medical devices company whose product is being studied — has done extensive work on the article without being named on the publication. Instead, one or more academic researchers may receive author credit.

Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.


Sunday, November 15, 2009

New Treatment for Autism 'Holds Promise'

A new treatment for autism appears to normalize brain function, according to Nashville physician Fred S. Starr, MD, FAACAP, BCIA-EEG.
In addition to high serotonin levels, autistic children have a characteristically common "u" EEG pattern reflecting impaired brain function, particularly in areas of the brain responsible for social interaction, communication, speech and bonding.
However, Quantitative EEG's conducted by Dr. Starr on autistic children after three weeks on the medication Respen-A showed that the children's brain patterning changed to "normal" patterning. Starr says that behavioral improvement was also "evident". "Speech, interaction and social skills improved markedly in patients using Respen-A, and displays of frustration and anger markedly diminished," Starr said.
The theory behind the use of Respen-A was developed by private researcher Elaine DeLack, Stanwood, WA. Unlike theories that center on negative reaction to vaccinations, DeLack looked at exposure to a commonly used drug used during delivery, and at brain enzymes that affect the brain both at birth, and again as the child enters childhood.


Saturday, November 14, 2009

UK study warns against anti-psychotics for dementia

* Most dementia patients given anti-psychotics needlessly

* Report could inform clinical practice around the world

* Global dementia cases seen doubling to 66 mln by 2030

More than 140,000 dementia patients in Britain are given anti-psychotic drugs needlessly and overprescribing of the medicines is linked to an extra 1,800 deaths in elderly people each year, a report said on Thursday.

The government-backed review showed that only around 36,000 of around 180,000 dementia patients prescribed anti-psychotics got any benefit from them -- findings it said could affect clinical practice in dementia across the world.

"Anti-psychotics are used too often in dementia," Sube Banerjee, the report's author and a professor of mental health and ageing at the Institute of Psychiatry at King's College London, said in a statement.

He said use of anti-psychotics drugs for dementia should be cut to a third of current levels in Britain and said his study would "provide international leadership in this complex clinical area."

Alzheimer's Disease International predicted in September that more than 35 million people around the world will suffer from dementia in 2010. That number is expected to almost double every 20 years, to 66 million in 2030 and more than 115 million in 2050. [ID:nN20262573]


Friday, November 13, 2009

Web-based counseling service Vets Prevail offered to veterans

Veterans in need of counseling, support or information to deal with mental and emotional issues can now turn to an online, interactive program called Vets Prevail. The services are provided confidentially and free of charge.

The website allows veterans to connect with other vets through forums, blogs and multimedia content. Vets can also sign up for a six-week online mental health program tool designed to help them build resilience and readjust to life after deployment. The aim of the training is to help vets tackle negative emotions and keep the trauma of the battlefield from affecting daily life and relationships.

About 500 veterans will be able to access the training program based on funds provided by Major League Baseball and the McCormick Foundation. However, organizers aim to continue the service with additional funding.


Thursday, November 12, 2009

Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research

This story was co-published with the Chicago Tribune.

Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleague

"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes.

During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.


Wednesday, November 11, 2009

Widespread Generic Erosion of Atypical Antipsychotics Will Cause the Bipolar Disorder Drug Market to Decline By More Than $1 Billion Through 2018

Decision Resources, one of the world's
leading research and advisory firms for pharmaceutical and healthcare issues,
finds that widespread generic erosion of branded atypical antipsychotics will
cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to
approximately $5 billion in 2018 in the United States, France, Germany, Italy,
Spain, the United Kingdom and Japan.

The new Pharmacor report entitled Bipolar Disorder finds that the market will
be constrained over the next several years by the patent expiries and
subsequent generic erosion of key antipsychotic agents such as AstraZeneca's
Seroquel, Eli Lilly's Zyprexa, Bristol-Myers Squibb/Otsuka's Abilify and
Pfizer's Geodon. In 2008, sales of atypical antipsychotics exceeded $4 billion
but generic competition, beginning in 2011, will cause sales of these agents
to decline to just under $3 billion by 2018, according to the report.
Additionally, patent expiries of branded antidepressants that include Wyeth's
(now Pfizer's) Effexor XR, Eli Lilly's Cymbalta/Xeristar and Forest/Lundbeck's
Lexapro/Cipralex will further constrain the market.


Tuesday, November 10, 2009

Adjunctive Psychotherapy for Depression Studied Findings suggest addition of psychotherapy does not increase remission over medication alone

Adjunctive psychotherapy added to antidepressant medications for patients with chronic depression did not increase the proportion of patients achieving remission, according to a study in the November issue of the Archives of General Psychiatry.

James H. Kocsis, M.D., of Weill Cornell Medical College in New York City, and colleagues treated chronically depressed patients using a two-phase treatment protocol with phase one consisting of an antidepressant medication used in accordance with a pharmacotherapy algorithm. After phase one, patients not achieving remission were randomized to 12 weeks of either continued medication and the addition of the cognitive behavioral analysis system of psychotherapy, continued medication and the addition of brief supportive psychotherapy, or optimized medication alone.


Monday, November 9, 2009

Genetic 'breakthroughs' in medicine are often nothing of the sort

During the second world war, the physicist Enrico Fermi asked General Leslie Groves of the US Army how many generals might be called "great" and why. Groves replied that any general who won five major battles in a row might be called great, and that about three in every hundred would qualify.

Fermi countered that if opposing forces are roughly equal, the odds are one in two that a general will win one battle, one in four that he will win two battles in a row, one in eight for three battles, one in 16 for four battles, and one in 32 for five battles in a row. "So you are right, General, about three in a hundred. Mathematical probability, not genius."1

There's an analogue of Fermi's "great general": the "great scientific discovery", or at least, as a case study, "the great genetic scientific discovery" as reported in the press. The discovery of genes for a certain behaviour, for schizophrenia, for happiness, always get good press coverage, usually based on publication in a respected scientific journal such as Science or Nature.

The research paper will include a statistic: the probability that the finding could have occurred by chance. The probability will have been sufficiently low that a reviewer for the journal was impressed and therefore recommended publication. Typically this probability or "P-value" will be less than 0.05, or 5%, which means the odds are less than one in 20 that the observed genetic correlation could have occurred by chance.


Sunday, November 8, 2009

Chronically Depressed? What to Do When Antidepressants Don't Work

The range of options includes cognitive behavioral therapy and brain stimulation techniques like ECT.

Last winter, confined to bed by intense sadness, exhaustion, and headaches, the University of Kansas student found herself considering suicide. Desperate after a years-long struggle with depression, she sought a treatment she had once viewed as extreme: electroconvulsive therapy. After a few sessions, "I literally went from almost unable to function—feeling suicidal—to a 180-degree change," she says.

The student, who still contends with depression, is one of the many people chronically in its grip who, disappointed by antidepressants, are finding some relief in therapies ranging from exercise to various forms of high-tech brain stimulation. Some 27 million Americans were taking an antidepressant in 2005, more than twice the number almost 10 years earlier, thanks largely to the arrival of Prozac and other effective antidepressants with fewer side effects. But a groundbreaking 2006 trial known as STAR*D revealed that about one third of people found total relief with their first drug, and around a third were not helped even after trying several drugs and combinations. ECT, which has been controversial since the days when it was performed without anesthesia and sometimes without proper consent, has evolved considerably in recent years; by inducing a seizure, it is thought to reset dysfunctional brain circuitry. It "is the most effective and rapidly acting treatment for severe depression," says Sarah Lisanby, a professor of clinical psychiatry at Columbia University Medical Center who is a leading brain stimulation researcher.


Saturday, November 7, 2009

FDA initiative targets drug prescription, dosing errors

The Food and Drug Administration wants to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs.

"When I first started looking at this, I was stunned at the scope of the problem," FDA commissioner Margaret A. Hamburg said Wednesday as she announced the new "Safe Use" program.

The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine.

The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine.


Friday, November 6, 2009

Genes And Environment May Interact To Influence Risk For Post-traumatic Stress Disorder

Individuals who experience both childhood adversity and traumatic events in adulthood appear more likely to develop post-traumatic stress disorder than those exposed to only one of these types of incidents, according to a report in the November issue of Archives of General Psychiatry, one of the JAMA/Archives journals. In addition, the risk was further increased in individuals with a certain genetic mutation.

Although 40 percent to 70 percent of Americans have experienced traumatic events, only about 8 percent develop PTSD during their lifetimes, according to background information in the article. PTSD is a complex anxiety disorder that involves re-experiencing, avoidance and increased arousal following exposure to a life-threatening event. "In addition to the obvious effect of environmental factors, PTSD has a heritable component," the authors write. Recent studies estimate that genetic factors account for approximately 30 percent of the difference in PTSD symptoms.


Thursday, November 5, 2009

Depression, drugs linked to preterm birth

Pregnant women with a history of depression who used psychiatric medication have triple the risk of premature child delivery, U.S. researchers found.

Researchers at the University of Washington, University of Michigan and Michigan State University found that a combination of medication use and depression -- either before or during pregnancy was strongly linked to delivery before 35 weeks' gestation.

Lead author Amelia Gavin of the University of Washington said the findings highlight the need for carefully planned studies that can clarify associations between depression, psychiatric medications and preterm delivery.


Wednesday, November 4, 2009

The Role of Antidepressants for the Treatment of Bipolar Depression

Although rapid-cycling bipolar disorder has been linked to the use of antidepressants, these treatments may still have a role in the management of patients with bipolar depression, said Stephen V. Sobel, MD, clinical instructor at the University of California, San Diego School of Medicine, in a presentation at the U.S. Psychiatric and Mental Health Congress is Las Vegas. Patients with bipolar disorder spend most of their time in depression, and antidepressants can alleviate these symptoms, said Sobel. “That’s why it’s so tempting to treat these patients with an antidepressant. But it’s important to be familiar with recent studies on the development of rapid-cycling bipolar disorder and to weigh the risks and benefits,” he said.

The use of antidepressants may increase a patient’s risk of rapid-cycling bipolar disorder. The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) included 1742 patients treated with a variety of approved medications for bipolar I and bipolar II disorder, and 32% reported having rapid-cycling at baseline. After 2 years of treatment, 5% still had rapid-cycling bipolar disorder. Those who were treated with an antidepressant were 3.8 times more likely to have rapid-cycling bipolar disorder.1


Tuesday, November 3, 2009

Regimens: A Supplement Didn’t Help Heart Patients

Patients with heart disease are at greater risk of dying if they are depressed. And both depression and heart disease are characterized, among other things, by low levels of omega-3 fatty acids.

So scientists wondered whether heart patients with depression might benefit from a dose of omega-3s in their antidepressant medicine. In a clinical trial, two groups of heart patients taking the antidepressant sertraline (Zoloft) were randomly assigned to receive a supplement of either omega-3s or a corn oil placebo.


Monday, November 2, 2009

What “Meaningful Use” of Electronic Health Records May Mean to Psychiatrists

With billions of dollars for electronic health record (EHR) technology purchases hanging in the balance, psychiatrists need to be paying attention to the Department of Health and Human Services (HHS) deliberations on the definition of “meaningful use.” HHS Secretary Kathleen Sebelius is supposed to set an interim definition in a few months. This is important to all office-based physicians because it will set the requirements they will have to meet for proving they are making meaningful use of EHR software and hardware they previously purchased. If they can make the case, starting in 2011, they would qualify for federal grants to partially compensate them for those previous software and hardware purchases.

Those grants are available for 5 years, and if obtained starting in 2011, they could amount to as much as $64,000 per practice for psychiatrists whose patient mix is at least 30% Medicaid recipients. That figure falls to $44,000 for physicians who cannot meet the Medicaid percentage and who see Medicare patients, with no specific percentage of the latter being designated.

There is also a penalty for physicians who do not meet the meaningful use definition. It comes into play after 2016; the Medicare fee schedule for professional services is reduced by 1% in 2015, by 2% in 2016, by 3% for 2017, and by between 3% to 5% in subsequent years.

The grants were authorized by the American Recovery and Reinvestment Act (ARRA)—which is the stimulus bill Congress passed last winter. Sebelius will set interim requirements based on recommendations from 2 new advisory committees that were established by the ARRA: a health information technology policy and a standards committee. The meaningful use requirements will be different, in part, for office-based physicians and hospitals, but they will have escalating requirements in 2011, 2013, and 2015.


Sunday, November 1, 2009

Long, hard road to marketplace for Vanda drug

Early next year, if all goes according to plan, doctors will be able to prescribe a new antipsychotic drug for patients with schizophrenia. When that happens, investors in a local pharmaceutical firm will surely breathe a sigh of relief.

While it's almost certain that the compound known as Fanapt will reach pharmacy shelves, the drug's future was anything but clear for most of its 13-year existence. Rockville-based Vanda Pharmaceuticals toiled for years on its development, even after larger drugmakers lost interest and the Food and Drug Administration gave the product a thumbs-down.

"Last year at this time, nobody believed in the company, and nobody believed in the compound," said Mihael H. Polymeropoulos, Vanda's president and chief executive. Today, the company has a deal for Fanapt worth nearly half a billion dollars.