ANTI DEPRESSANT DRUG BLOG

Prisons see more inmates requiring mental health care

July 31, 2006

A few years ago Carol Cousins was living in a nightmare of her mind’s own creation — one in which a CIA agent was stalking her.
The 35-year-old, who now resides in Duluth, had spiraled into a world of paranoid delusions and anxiety. Diagnosed with bipolar disorder and depression, Cousins believed a male CIA agent had released poisonous gas inside her South Carolina home and was trying to communicate with her through songs on the radio.
She drove to Washington, D.C., in 2003, seeking help from the FBI, but wound up being arrested several times by local police. The first arrest occurred because a couple thought Cousins was following their vehicle on the highway. It turned out to be a misunderstanding.
Cousins mistakenly thought she was following a different couple who had helped her earlier that day. However, when Cousins told police about her CIA agent delusions, they detained her for two days in jail before a judge ordered them to free her.
Two weeks later, Cousins was pulled over again by police for driving the wrong way on a street she was unfamiliar with. A check of her driver’s license revealed her father had reported her missing and flagged her as a mentally ill person. She was arrested and held until her father could pick her up.
Cousins now leads a stable life because of medication and treatment. She even runs a support group in Lawrenceville for bipolar disorder and has a master’s degree in psychology.
Research shows that, like Cousins, about 80 percent of people suffering from mental illness can be successfully treated and function normally in society. But finding the right medication or therapy is often a long, tortuous journey for them and their loved ones.
Antipsychotic and antidepressant drugs often make people feel bad, so they quit taking them. Or prescription drugs may be too expensive or unavailable, causing a large number of mentally ill people to self-medicate with alcohol and illegal narcotics. Often it takes years for someone to admit they need long-term medical intervention to stabilize their emotional and mental state.
But Cousins was actually one of the lucky ones — a person with mental illness who has learned to cope and stay out of prison.
Many other people with mental illness become locked in a never-ending cycle of incarceration, national statistics show. The prison system in the United States has taken the place of government-funded asylums ever since the deinstitutionalization movement of the 1960s, according to the nonprofit Treatment Advocacy Center.

Prisons providing
mental health care
In 1965, Congress ceased funding state psychiatric hospitals through Medicaid. Federal officials intended to implement a system of community mental health centers to replace the state psychiatric hospital systems. However, as a result of that decision, most patients were discharged onto the streets. Hundreds of thousands of patients became homeless with no access to medication or treatment and were incarcerated.
In the past four decades, America has lost effectively 93 percent of its state psychiatric hospital beds, resulting in increased rates of homelessness, incarceration, suicide, victimization and violence, according to the Treatment Advocacy Center. The largest mental health facility in the country is now the Los Angeles County jail.
“There is no system for people in crisis, so police are the ones that end up responding to these people,� said Ron Honberg, legal director for the National Alliance on Mental Illness (NAMI). “Most of these people are not doing anything terrible, maybe something unusual or unlawful, but often not violent. We basically stand around and let people reach the point where they are engaging in criminal behavior before we do anything.�
The federal Bureau of Justice Statistics estimates there are 283,800 mentally ill offenders in jails and prisons in the United States. An additional 547,800 are on probation. About 16 percent of those in state and local jails are mentally ill.
Georgia prisons are on par with national statistics. Roughly 7,700 of 46,600 state inmates were receiving mental health services in June 2006, or about 16 percent, according to an independent audit of the Georgia Department of Corrections. The budget for the Georgia prison system’s mental health care in 2005 was more than $29 million.
Caring for just one mentally ill state inmate costs a whopping $4,025 per year.
Alarmingly, while the number of inmates being treated for mental illness has increased 73.4 percent between 1999 and 2006, the number of psychiatry hours decreased by 31.8 percent and psychology hours decreased by 24.6 percent, according to the independent audit. Picking up the slack are full-time counselors, whose staffing levels increased by 43.2 percent.
The independent auditor for the Georgia Department of Corrections, Jeffrey Metzner, said in his findings the increase in counselor positions was “encouraging,� but said the majority were unlicensed counselors. This increase in unlicensed counselors and decrease in psychologists and psychiatrists was causing “a significant supervision problem,� Metzner said.
The public information office of the Georgia Department of Corrections initially granted a request by the Gwinnett Daily Post to tour facilities for the mentally ill at Phillips State Prison in Buford. However, several days before the tour was to take place, it was canceled without explanation.

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Yolanda Thompson, spokeswoman for the Georgia Department of Corrections, said other unnamed officials had reviewed the request and would not be able to schedule a tour “at this time.� She declined to reschedule the tour.
Dr. Dana Tatum supervises the mental health care for 268 chronically mentally ill inmates in the Gwinnett County Detention Center. About 200 of them are on antidepressant or antipsychotic medication. He said when the Georgia Mental Health Institute on Briarcliff Road in Atlanta closed in the late 1990s, the jail’s population of inmates with mental illness increased dramatically.
“The schizophrenic and chronically ill mental population just exploded and we found ourselves being the hospital,� Tatum said.
That prompted jail officials to open “H Pod� at the Gwinnett jail in 1998, a housing unit specifically designed for patients suffering from severe mental illness. As of Monday, there were 29 inmates in H Pod. The detention center employs six full-time counselors and one part-time counselor. Last month alone, those counselors had more than 1,650 patient contacts, Tatum said.
“We are not a treatment facility, yet if you have a mentally ill spouse or loved one, this a good place to be,� Tatum said. “We have individual counseling, emergent care, psychiatry on call 24/7 and group therapy. We are taking care of these people because it’s the right thing to do and also because we are the hospital now.�

Changing directions
Government officials and mental health advocates seem to agree that more nonviolent inmates from jails and prisons should be diverted into treatment programs.
Advocates for the mentally ill said government should fund mental health care in jails, but more money needs to be provided for outpatient treatment, job placement, housing assistance and access to medication. An up-front investment to help people with mental illness function in society would prevent taxpayers from the shouldering the end costs of
incarceration.
“NAMI believes the majority of people with mental illness, if they receive appropriate services, can live in the community,� Honberg said.
A statewide effort is under way to teach police officers how to recognize symptoms of mental illness and de-escalate crisis situations. Since the first Crisis Intervention Training program was taught in December 2004, 75 law enforcement agencies across the state have participated, including Lawrenceville Police, Gwinnett County Police and the Gwinnett County Sheriff’s Department.
Crisis Intervention Training brings together police, mental health providers and consumers to determine what alternatives to incarceration are available in the community. The program was funded by a $450,000 grant from the Georgia Department of Human Resources.
Janet Oliva of the Georgia Bureau of Investigation helped get the curriculum off the ground. Oliva said the state’s goal is to train 20 percent of each law enforcement agency by 2007.
Officers receive 30 hours of classroom instruction on mental health topics and 10 hours of crisis de-escalation skills.
“We don’t want the officer to get hurt, or the consumer or any bystander or family member,� Oliva said. “This helps weed out persons that don’t need to be in jail. Also it’s a huge liability decrease, because if you respond safely and effectively to a crisis, no one gets hurt unnecessarily.�
Mental health advocates strongly advocate CIT.
“Since police are the ones getting there first, we feel very strongly that they need to be properly trained to know how to respond to people in a way that calms the person down and de-escalates the crisis,� Honberg said.
Lawrenceville Police Capt. Greg Vaughn said he has tried the tactics taught in CIT several times and found them effective.
“I believe in it,� Vaughn said. “We’re not asking officers to drop their guard. But when you’ve got a mental person in a crisis, sometimes you have to listen to them, try to convince them that you want to help them and not arrest them.�
Another state-funded program working to rescue people suffering from mental illness from the cycle of imprisonment is called Transitional Aftercare for Probationers and Parolees (TAP).
The program’s focus is to have a case manager begin assisting mentally ill and mentally retarded inmates prior to being released on probation with resources they need to reintegrate into society, said Bill Kissell, director of the office of quality and evaluation for the mental health division of Georgia Department of Human Resources.
A case manager meets with prison mental health staff to determine the needs of the inmate prior to their discharge from prison. The case manager helps the inmate find a residential program if they haven’t already found somewhere to live, and assists with vocational planning or employment placement.

Courts take initiative
Another option to divert nonviolent offenders with mental illness out of jail is mental health court. Much like the drug and DUI courts already operating in Gwinnett County, a mental health court involves closer monitoring and intensive treatment for offenders instead of jail time.
Hall County Superior Court has operated a mental health court, called Health, Empowerment, Linkage and Possibilities (HELP), for the past two years with some success. There have been 32 participants, and only four were terminated from the program for failing to comply with
standards.
An independent evaluation of the Hall County mental health court by Georgia State University published in June 2006 found clients in the program had greater psychological and emotional stability. However, more resources were needed for residential placement, job opportunities and staffing of case managers, the evaluation stated.
“We wanted to develop a program we could grow from,� Kissell said. “We think there are some serious successes with HELP.�
The Hall County program was funded through fiscal year 2006 by the Governor’s Criminal Justice Coordinating Council, but because of federal cuts, the funds may no longer be available. The court is seeking alternate funding through state grants to continue its operation, said HELP case manager Melin Foscue.

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Some say hope is the best antidepressant

July 28, 2006

One of the fiercest debates in the mental-health field is whether medication is necessary to treat depression and anxiety. Some experts say the conditions have a biological cause and that pharmaceuticals can correct a chemical imbalance in the brain. Other people claim that mood disorders can be conquered with talk therapy (or exercise and vitamins, if you believe Tom Cruise) and that those who pop pills for all that ails them are simply looking for a quick fix. Two new books argue that nondrug approaches are where it’s at.

David D. Burns’s When Panic Attacks: The New, Drug-Free Anxiety Therapy That Can Change Your Life (Morgan Road Books, $34.95) promotes cognitive-behavioural therapy, which proponents say helps people learn how to change negative thoughts. The Stanford, California, psychiatrist is best known for Feeling Good: The New Mood Therapy (first published in 1980), which focuses on depression and has sold more than four million copies. Burns claims that Feeling Good is the book most often recommended to patients by American and Canadian mental-health professionals. He’s hoping that “CBT bibliotherapy� will be equally effective in helping those who suffer from anxiety.

He certainly has a wide potential audience. According to the Public Health Agency of Canada, anxiety affects 12 percent of the population. Another eight percent of adults will experience a “major depression� at some point in their lives. Symptoms of anxiety include feeling nervous, worried, frightened, or tense; sweating, trembling, or having difficulty breathing; and pain or tightness in the chest or upset stomach. Among the signs of depression are hopelessness, worthlessness, and a loss of pleasure or satisfaction in everyday life.

Distinguishing between anxiety and depression isn’t easy, because the two often go together. Anxiety, Burns writes, results from the perception of danger, while depression occurs from the sense that a tragedy has already happened. If you’ve been feeling anxious, especially for an extended period, you’re also likely to be depressed, and vice versa.

Burns doesn’t buy the claim that depression or anxiety results from a chemical imbalance in the brain. “This theory is fueled more by drug company marketing than by solid scientific proof,� he writes. “Billions of dollars of annual profits from the sale of antidepressant and anti-anxiety medications are at stake.…They [drug companies] also subsidize a large proportion of the budget of the American Psychiatric Association and underwrite an enormous amount of research and education at medical schools.�

Burns acknowledges that in some cases, medications can be helpful, even lifesaving. Nevertheless, he says many people who swear that a drug pulled them out of an emotional pit are in fact experiencing a placebo effect. “Numerous research studies have shown that if you give an inert placebo to people who are suffering from depression, at least 30% to 40% of them will recover.…It was the patients’ expectations, not the pills, that caused them to get better.…Hope is the most potent anti depressant in existence.�

Regardless of what the best treatment really is—antidepressants, cognitive-behavioural therapy, or a combination of the two—people who need help for anxiety or depression face a big problem: long waiting lists. In B.C., family doctors typically tell patients they can expect to wait six months to see a psychiatrist. The waiting period to get into the Anxiety Disorders Clinic operated by Vancouver Coastal Health and UBC varies from case to case but ranges from about four months to a year, according to UBC’s public-affairs department. For people in emotional distress, such delays only make things worse. That’s where Burns’s book comes in.

When Panic Attacks is a practical, user- friendly guide to a complex health issue. It’s written in plain language, so readers won’t be overwhelmed by scientific jargon, and Burns provides a clear description of the cognitive “distortions� that characterize anxiety. Among them are all-or-nothing thinking (when people look at things in absolute, black-and-white categories), mind-reading (assuming that others are extremely judgmental and critical), and emotional reasoning (“I feel like a loser, so I must be one�).

Identifying cognitive distortions is one step in the “daily mood log� that Burns suggests readers fill out regularly. Based on the premise that when you change the way you think, you change the way you feel, the log helps people see that their negative perceptions aren’t based in reality. But Burns doesn’t stop there. Negative thoughts surface when people are upset, he explains, while self-defeating beliefs are always present. The book helps readers pinpoint personal values and attitudes—fear of rejection, conflict phobia, and feelings of inferiority, for instance—that lead to psychological vulnerabilities.

The log and other “worksheets� in the book point readers to specific cognitive techniques—40 of them—that they can use to defeat their fears and worries. Everybody is different, and what works on one person won’t necessarily help another. But according to Burns, cognitive therapy does, in fact, work.

An anti-antidepressant view is one Gordon Warme holds in Daggers of the Mind: Psychiatry and the Myth of Mental Disease (House of Anansi Press, $34.95). The Toronto doctor, who specializes in psychiatry and psychoanalysis, gives a refreshingly honest critique of his profession in his memoir. (Daggers is definitely not a self-help book.)

“We have wonderful drugs for the treatment of depression, say the colleagues who think their patients are somatically abnormal, an idea that excites them so much they haven’t noticed that the incidence of depression exploded as soon as it was thought there was a drug treatment available,� Warme writes. “I’m pretty sure that, more often than not, these excellent outcomes of treatment are yet another placebo effect.�

Not surprisingly, given his specialty, Warme advocates long-term psychotherapy for people experiencing psychological pain. He claims that major personal change can only come about as a result of unremitting pressure—pressure to think and think again.

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Love, sex, loneliness, and success are what inspire people or make them mad, he maintains, and eventually “reality breaks through.�

Throughout Daggers of the Mind, Warme refers to everyone from Carl Jung and Deepak Chopra to Anna Karenina and King Lear. Then there is Buddha, whom Warme quotes and who could have had the book’s last word: “Pain is inevitable, but suffering is optional.�

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Prescription Pain Killers Are Involved In More Drug Overdose Deaths

July 24, 2006

Trends analysis of drug poisoning deaths has helped explain a national epidemic of overdose deaths in the USA that began in the 1990s, concludes Leonard Paulozzi and colleagues at the Centers for Disease Control and Prevention in Atlanta, USA. The contribution of prescription pain killers to the epidemic has only become clear recently. This research is published this week in the journal, Pharmacoepidemiology and Drug Safety.

Drugs called “opioids” are frequently prescribed to relieve pain, but if abused they can kill. Over the past 15 years, sales of opioid pain killers, including oxycodone, hydrocodone, methadone and fentanyl, have increased, and deaths from these drugs have increased in parallel.

In 2002, over 16,000 people died in the USA as a result of drug overdoses, with most deaths related to opioids, heroin, and cocaine. Opioids surpassed both cocaine and heroin in extent of involvement in these drug overdoses between 1999 and 2002.

The situation appears to be accelerating. Between 1979 and 1990 the rate of deaths attributed to unintentional drug poisoning increased by an average of 5.3% each year. Between 1990 and 2002, the rate increased by 18.1% per year. The contribution played by opioids is also increasing. Between 1999 and 2002 the number of overdose death certificates that mention poisoning by opioid pain killers went up by 91.2%. While the pain killer category showed the greatest increase, death certificates pointing a finger of blame at heroin and cocaine also increased by 12.4% and 22.8% respectively.

In an accompanying ‘comment’ article, David Joranson and Aaron Gilson of the University of Wisconsin School of Medicine and Public Health Comprehensive Cancer Centre; Pain & Policy Studies Group, of Madison, Wisconsin. They caution against increasing unwarranted fears of using opioid analgesics in pain management, noting that much of the abuse of opioid analgesics is by recreational and street users and individuals with psychiatric conditions rather than pain patients.

Joranson and Gilson also point to the large quantity of opioid analgesics stolen from pharmacies every year, saying that “overdose deaths involving prescription medications do not necessarily mean they were prescribed. It is also crucial to know that most overdose deaths involve several drugs and these data cannot attribute the cause to a particular drug.”

In a second commentary, Scott Fishman, Professor of Anaesthesiology and Pain Medicine at University of California, Davis concludes that drug abuse and under treated pain are both public health crises, but the solution to one need not undermine the other. “The least we can do is make sure that the casualties of the war on drugs are not suffering patients who legitimately deserve relief,” he says.

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Earnings Preview: Wyeth

July 19, 2006

Wyeth reports earnings for the fiscal second quarter on Thursday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: A boost to sales in the antidepressant market is expected to translate into stronger sales of Effexor, the company’s best-selling drug with $3.5 billion in global sales in 2005, balancing rocky news in the second quarter. The company suffered a minor setback in late May when studies showed Effexor’s successor DVS-233 showed higher-than-expected nausea rates. Also in May, the company received a Food and Drug Administration warning letter over manufacturing practices at a plant in Puerto Rico where Wyeth makes birth control pills, hormone replacement drugs, antidepressants and over-the-counter pain relievers.

BY THE NUMBERS: The company recently reiterated its annual earnings-per-share guidance of $2.97 to $3.07, saying earnings would gravitate toward upper end of the range if current business trends continue. Analysts surveyed by Thomson Financial estimate earnings per share of 76 cents on revenue of $4.96 billion for the second quarter.

ANALYST TAKE: Friedman Billings Ramsey analyst David Moskowitz forecast earnings per share of 73 cents on $5 billion in sales, driven by a 5 percent rise in antidepressant prescriptions, which should keep Effexor revenue steady. Moskowitz also sees arthritis drug Enbrel and pneumonia treatment Prevnar driving sales.

Cowen & Co. analyst Steve Scala sees Wyeth as one of the best performing drug makers in the U.S. sector, and forecast earnings per share of 75 cents on sales of $4.99 billion, with a 1 percent rise in Effexor sales to $900 million and a 24 percent increase in Prevnar sales to $400 million.

WHATS AHEAD: Toward the end of the quarter, the FDA asked Wyeth for more data on its period-stopping birth control pill Lybrel and plans to discuss the drug at a panel meeting later in the year.

STOCK PERFORMANCE: Shares of Wyeth fell nearly 9 percent over the second quarter to close at $44.41. Since the beginning of the year, shares have declined nearly 4 percent. They closed at $43.16 on the New York Stock Exchange Monday.

© 2006 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Consumers to profit big as drugs go off patent

July 17, 2006

Consumers stand to save billions of dollars in prescription drug costs in the next few years as an unprecedented wave of expensive brand-name medications come off patent, facing competition from far-cheaper generic versions.

Four of the nation’s 10 best-selling prescription medicines – treating common ailments ranging from high cholesterol to asthma – are due to lose patent protections starting this year through 2010. Never have so many branded drugs, with annual sales of as much as $75 billion, lost their patents in so brief a time, experts say.

The savings for consumers could be enormous. Unlike hospital or doctor care, which are expensive but paid mostly by health insurance, patients pay a relatively higher share of prescription drug costs out of their own pockets. The high cost of brand-name drugs has driven many Americans to import lower-cost versions from Canada and other nations. Generics can cost as much as 80 percent less than branded versions.

General Motors Corp., for example, said employees in its prescription drug plan are paying 90 cents a pill for the generic version of cholesterol-lowering Zocor, which lost its patent last month, compared with as much as $4.50 for the branded version.

Users of rival cholesterol-fighter Lipitor, the nation’s top-selling prescription medication whose patent doesn’t expire until 2011, could also save by switching to generic Zocor.

The generic versions generally offer no loss in quality and effectiveness, medical experts say.

“For the vast majority of patients, generics work just like the brand drugs,� said Debra Judelson, a Beverly Hills, Calif., cardiologist.

Generic drugs have been around for decades and their share of prescriptions filled have grown steadily over the years, accounting for just over half of all prescription drugs sold today versus a quarter two decades ago. That share could rise beyond 60 percent by the end of next year, said Ron Fontanetta, a healthcare specialist at Towers Perrin, a human resources consulting firm.

The upcoming surge of generics stems from an innovation boom in the early 1990s, when giant drug companies such as Merck & Co. and Pfizer Inc. launched blockbuster drugs.

By law, patents last about 20 years, but companies spend many of those years testing and getting government approvals for their new drugs. The creators are typically left with between 12 and 14 years of exclusive rights to sell the drugs, usually at high prices, to recoup the enormous costs in inventing and developing the treatments.

Many of those patents from the 1990s innovation wave are now beginning to expire.

A few days after Merck’s cholesterol-fighter Zocor, the nation’s No. 2 selling prescription drug, lost its patent last month, Pfizer’s antidepressant Zoloft, ranked No. 7, lost its patent. The patent for Pfizer’s high blood pressure medicine Norvasc expires next year.

Express Scripts Inc., one of the country’s largest managers of pharmacy health benefits, estimates the potential overall savings from generics this year alone is $24.7 billion.

That is unlikely to make a major dent in the country’s overall escalating healthcare bill, at $2.6 trillion.

But for many patients’ health budgets, the savings can be huge. Patients with health insurance pay as much as a quarter of prescription drug costs out of their own pockets, compared with 20 percent for dental, 16 percent for physician services and 7 percent for hospitals.

How much consumers will save depends on how aggressively health plans and care providers steer patients to generics.

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Bias issue dogs psych-drug study

July 12, 2006

Authors of a study suggesting pregnant women should stay on anti-depressants had undisclosed industry ties, a report said Tuesday.

According to a report published Tuesday in the Wall Street Journal, the lead author of a study — in the February issue the Journal of the American Medical Association — that found that pregnant women who go off anti-depressants risk relapsing into depression had undisclosed ties to several makers of the depression therapies.

Lead researcher Lee Cohen, a professor at Harvard Medical School, “is a longtime consultant to three antidepressant makers, a paid speaker for seven of them, and has his research work funded by four drug makers,” WSJ reported.

But Cohen’s industry connections were not disclosed in the JAMA article, the report said. Combined, the study’s authors have “60 different financial relationships with drug companies,” the Journal said.

The possible risks of anti-depressants in pregnant women had been recently highlighted by another study appearing in the New England Journal of Medicine, which found a six-fold increase in the risk of severe respiratory failure among infants whose mothers took anti-depressants called selective serotonin reuptake inhibitors (SSRIs) late in their pregnancies.

In the WJS report, JAMA Editor in Chief Catherine De Angelis said JAMA was unaware of the Cohen study authors’ industry ties. She said an “explanation” from the authors was forthcoming in an upcoming issue of JAMA.

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Spectrum Pharmaceuticals’ Board of Directors Re-elected at Annual Stockholders Meeting

July 11, 2006

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) announced today that all six of the Company’s nominees to the Board of Directors were re-elected at the Annual Meeting of Stockholders held on Thursday, July 6, 2006 at 10:00 a.m. PT at the corporate headquarters in Irvine, CA. Each of the six continuing directors, who received over 94% of the votes cast, will serve for a one-year term. The continuing directors are Dr. Stuart Krassner, Mr. Anthony Maida, Dr. Dilip Mehta, Dr. Rajesh Shrotriya, Dr. Julius Vida and Mr. Richard Fulmer. In addition, the stockholders approved by over 93% of the votes cast a proposal to increase the authorized number of shares of common stock to 100 million shares.

“As we begin our transformation from a drug development to a commercialization company, I believe we have the right team in place to guide us during this exciting period,” stated Dr. Shrotriya, Chairman, CEO and President of Spectrum Pharmaceuticals. “My fellow Board members have tremendous experience in the biotechnology arena and a track record of success. With their varied backgrounds in academia, research and development, licensing, business development, finance and marketing, I believe we have the necessary mix of talent and experience to drive continued success for the company and its stockholders.”

BIOGRAPHIES
Dr. Stuart Krassner
* Over forty years of experience in various positions at the University
of California, Irvine, at the School of Biological Sciences.
* Developed and reinforced FDA and NIH compliance procedures for
UCI-sponsored human clinical trials and animal research, and
established UCI’s first institutional review board.
* Published many articles in peer-reviewed journals and lectured at
Harvard Medical School, The John Hopkins University, NIH, and WHO.

Mr. Anthony Maida
* Over twenty-five years of experience in senior executive positions,
including fifteen years as CEO of several emerging biotech companies.
* Served as Senior Financial Controller of $1.7 billion division of
Lockheed Missiles and VP, CFO of Dataplant, Inc.
* Provides technical and corporate advisory services to many
pharmaceutical firms, serves on a number of biotechnology boards and
advises many investment and venture capitalist firms.
* Currently involved in basic research involving tumor immunology.

Dr. Dilip Mehta
* Over forty years in the pharmaceutical industry in several top-level
executive positions.
* Spent fifteen years at Pfizer, Inc., most recently as Senior Vice
President, U.S. Clinical Research.
* Under his leadership, numerous drugs were developed and many achieved
multi-billion dollar annual sales, including Zithromax®, Viagra®,
Norvasc®, Zoloft® and others.
* Served as Chair, Efficacy Section, for the Pharmaceutical Research and
Manufacturers of America (PhRMA).
* Currently serves as a member of the FDA’s Psychopharmacology Advisory
Committee.

Dr. Rajesh Shrotryia
* Over thirty years of experience in a number of senior executive
positions at several publicly traded pharmaceutical companies focused
in the area of oncology research.
* Spent eighteen years at Bristol-Myers Squibb Company, a leading
pharmaceutical company in the area of cancer products.
* Has served as Chairman, CEO and President of Spectrum since August
2002.

Dr. Julius Vida
* Over forty years of experience in the pharmaceutical industry.
* Spent eighteen years at Bristol-Myers Squibb Company, most recently as
VP, Business Development, Licensing and Strategic Planning, where he
was credited for in-licensing numerous drugs, many of which reached
annual sales in the billions of dollars.
* Serves as a member of the Board of Directors of several biotechnology
companies.
* Played an integral role in licensing satraplatin to Spectrum prior to
being appointed to the Company’s board of directors.

Mr. Richard Fulmer
* Spent twenty-four years at Pfizer, Inc. in a number of high-level
marketing and business development capacities, including over five
years as Vice President Licensing and Development.
* Was a key part of the commercial launch of the leading anti-fungal
agent Diflucan, the number one selling SSRI antidepressant Zoloft, and
the novel alpha-blocker Cardura used for benign prostate hypertrophy.
* Responsible for the formation of a strategic alliance between Pfizer
and Eisai related to the clinical development and commercialization of
Aricept for Alzheimer’s disease, the creation of a co-development and
co-promotion agreement between Pfizer and Park Davis for Lipitor, and
the creation of an alliance at Pfizer for the commercialization of
Exubera, a pulmonary insulin product.

Following the formal business of the meeting, Dr. Shrotriya discussed Spectrum’s achievements since the annual stockholders meeting in 2005, as well as reiterated the Company’s key milestones for the next 18 months.

The key milestones anticipated in 2006 and 2007 include:

* Full analysis of Phase 3 clinical trial data for satraplatin will be
completed in the fall, and if the data is positive, the rolling new
drug application (NDA) could be completed in the U.S. by the end of
2006.

* If the NDA for satraplatin is approved, the product could be on the
market in the second half of 2007.

* Submission of the response to the CMC questions on LFA is expected in
the first quarter 2007, and if the product is approved, it could be on
the market in late 2007.

* Initiation of the Phase 3 trial in the U.S. for EOquin(TM) is expected
in the fourth quarter of 2006.

* The patent trial for the Company’s generic product, sumatriptan
injection, the generic version of GlaxoSmithKline’s Imitrex®
injection, is planned for November 2006, and if the Company is
successful in the litigation and the abbreviated new drug application
is approved, the product could be on the market in late 2007.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval.

Forward-looking statements

This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, the transformation from a drug development to a commercialization company, the right team in place to guide us during this exciting period, the necessary mix of Board talent and experience to drive continued success for the company and its stockholders, that full analysis of Phase 3 clinical trial data for satraplatin will be completed in the fall, and if the data is positive, that the rolling new drug application (NDA) could be completed in the U.S. by end of 2006, that if the NDA for satraplatin is approved, the product could be on the market in the second half of 2007, that the submission of the response to the CMC questions on LFA is expected in the first quarter 2007, and if the product is approved, it could be on the market in late 2007, that the patent trial for the Company’s generic product, sumatriptan injection, the generic version of GlaxoSmithKline’s Imitrex® injection, is planned for November 2006, and if the Company is successful in the litigation and the abbreviated new drug application is approved, the product could be on the market in late 2007, that the initiation of the Phase 3 trial in the U.S. for EOquin(TM) is expected in the fourth quarter of 2006, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission.

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Drug Company Profits Seen a Bit Higher

July 7, 2006

U.S. pharmaceutical companies are expected to post modestly higher sales and operating earnings for the second quarter, helped by cost cuts and new products.

However, several companies face continued pressure from generic competition for best-selling drugs.

The largest biotechnology companies, meanwhile, should report healthier earnings growth on sales of pricey cancer-related drugs.

Analysts estimate several large generic-drug companies had profit declines or limited earnings growth in the last quarter because of intense price competition.

For a few big makers of branded drugs, the quarter that ended June 30 was the last in which they could command high prices for three drugs that have generated billions of dollars in sales during the years. Patents expired for two cholesterol-lowering pills from Bristol-Myers Squibb Co. and Merck & Co., as well as for Pfizer Inc.’s Zoloft antidepressant. Each had sales exceeding $2 billion last year.

The patent expirations have cleared the way for cheaper, generic versions of the medications. Sales generated by the branded versions are expected to drop dramatically. The branded-drug companies remain hard-pressed to generate enough revenue from new products to replace the lost revenue from patent expirations in the near term.

What’s more, the patent expiration for Merck’s Zocor cholesterol-lowering pill has had a ripple effect across the industry. For instance, drug-benefit plans have switched members from Pfizer’s Lipitor cholesterol pill, which still has patent protection, to Zocor in anticipation of the generic version.

The switching has made it difficult for Pfizer, the biggest drug company by sales, to sustain the growth rate for Lipitor, which nonetheless remains by far the best-selling drug in the world. First-quarter Lipitor sales were weaker than expected, and all eyes will be on Pfizer’s second-quarter figures to see if the trend continued.

“An aggressive cost-cutting plan lends some consolation on near-term” earnings at Pfizer, “but longer-term growth will clearly rely on Lipitor’s franchise value in the intermediate term and new drug successes,” Deutsche Bank analyst Barbara Ryan wrote in a recent research note.

Ryan doesn’t own Pfizer shares. Deutsche Bank or its affiliates, or both, own at least 1 percent of Pfizer shares. The firm has received investment-banking compensation from Pfizer in the past year.

Pfizer and other drug makers have trimmed their sales forces and taken other steps to cut costs. But many investors also want to see the companies invest in drug development and product launches so that the companies return to meaningful revenue growth.

Toward that end, the industry recently has won regulatory approval for several new products that could become blockbusters, including Merck’s Gardasil — a vaccine designed to prevent the virus that causes cervical cancer — and Genentech Inc.’s Lucentis to treat a form of eye disease.

Still, approvals for some drugs are hard to come by in the wake of Merck’s 2004 withdrawal of the painkiller Vioxx because of safety concerns. Drug companies say the U.S. Food and Drug Administration has tightened its scrutiny of new drug applications, leading to delays or outright rejections. Bristol-Myers, for example, recently scrapped plans to continue developing a diabetes drug after the FDA last year requested additional data about its cardiovascular risks, which would have required additional studies.

Most biotech companies are losing money as they develop products. But some big biotechs are expected to post earnings gains for the second quarter. Genentech, which is majority-owned by Roche Holding AG of Switzerland, is expected to benefit from brisk sales of cancer treatments Avastin, Rituxan and Herceptin, while analysts expect more modest growth at Amgen Inc., which sells Aranesp to treat anemia in cancer and kidney-dialysis patients.

Although generic-drug companies are aggressive in challenging patents and selling copycat versions when patents expire, intense price competition is limiting profit growth at several companies. Watson Pharmaceuticals Inc., for instance, is expected to post a decline in earnings, excluding one-time items.

One notable exception is the biggest generic company, Teva Pharmaceutical Industries Ltd., an Israeli company with sizable U.S. operations. Teva recently bolstered its product line by acquiring another U.S. generic company, Ivax. It also is selling or plans to sell the generic versions of the three big blockbusters that have lost patent protection in recent months: Pravachol, Zocor and Zoloft.

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Patients seek unapproved depression therapy

July 5, 2006

Pediatrician Laura Schulman suffered from depression so severe that it forced her to stop practicing medicine five years ago. A string of drug cocktails over the years failed to help. Then she read about an experimental treatment called repetitive transcranial magnetic stimulation.

The treatment hadn’t been approved for depression, but a clinic in Canada was offering it to U.S. residents, and would even help arrange travel and lodging. So last summer, the Seattle resident dipped into her savings and headed north to a MindCare Centers clinic in Vancouver, British Columbia, where three to four weeks of treatment costs nearly $7,000.

After a few sessions of rTMS, which delivers electromagnetic pulses to the brain via a magnetic coil held against the skull, Schulman says she felt her depression lifting. As she made her way around Vancouver she started finding it easier to manage everyday tasks that had once felt so burdensome — such as buying a bottle of water at a corner store.

“It was like putting on glasses for the first time if you’ve been myopic all your life,” she says.

Schulman is one of many desperate patients leaving the U.S. to obtain rTMS after failing numerous antidepressant medications. And while some doctors are cautioning patients to wait for the Food and Drug Administration to weigh in, scores of other patients have traveled to U.S. clinics that offer the treatment on an “off label” basis.

The technique is approved in the U.S. only for brain research, but doctors can use it to treat depression, just as other drugs and therapies can be used in applications other than those for which they are approved. In Canada, the rTMS device has limited federal approval for safety, but provincial health-insurance plans won’t cover it, citing lack of evidence on its efficacy.

The therapy is showing promise in studies. In the first big multisite trial of rTMS, the method was shown to benefit about 42 percent of patients with treatment-resistant depression — or severe depression that doesn’t improve with medication. And side effects were considered mild, mostly consisting of headache.

The 300-patient study, released in May, was sponsored by Neuronetics, which is seeking Food and Drug Administration approval for use of its rTMS device in treating depression. A spokeswoman for the FDA declined to comment on the review process.

Many psychiatry experts say rTMS is likely to be approved soon in the U.S. But some doctors note that for now, the clinics in both Canada and the U.S. are operating without direct regulatory authority, and may not be following the same protocols in screening patients that researchers use in their clinical trials. So some patients who aren’t appropriate candidates may be paying for pointless treatment, these doctors say, and failing to pursue the treatment that they do need.

Since rTMS isn’t covered by insurance, patients typically pay thousands of dollars out of pocket.

“The results are very promising, but standards need to be in place” before patients seek treatment, says Sarah H. Lisanby, a lead investigator on the Neuronetics study and a psychiatrist at the Brain Stimulation and Neuromodulation division of the New York State Psychiatric Institute.

Treating stubborn depression remains one of psychiatry’s most puzzling problems. About 14 million people in the U.S. suffer from depression, and about 70 percent don’t fully respond to the first antidepressant drug they try. At least one-third of patients still have symptoms after adding a second drug or switching to another medicine, according to recent studies by the National Institutes of Health.

“These are people who’ve lived their lives in misery or have tried many medications,” says Mark George, a psychiatrist at the Medical University of South Carolina, who is an investigator on the Neuronetics trial and has consulted for the MindCare clinics.

Only two nondrug treatments have been approved by the FDA for depression. Electroconvulsive therapy, or ECT, is considered the gold standard in hard-to-treat cases, based on its efficacy. But because it works by causing a seizure, it must be performed in a hospital.

And it can have serious side effects, including memory loss and cognitive problems. Schulman of Seattle, for instance, said she didn’t want to try ECT because of the risk of side effects.

Vagus nerve stimulation, approved last year, involves surgery to implant a device in the neck, but is only approved as an add-on to medication for chronic or recurrent depression.

In rTMS a strong magnetic field is directed through a coil held against the head for a series of sessions that last less than an hour each. The magnetic force stimulates a part of the brain believed to play a role in depression. The treatment doesn’t require anesthesia and produces few side effects, though it doesn’t work for as many people, or as effectively, as ECT.

The treatment does carry a small risk of seizure, and the American Psychiatric Association guidelines for research state that rTMS should be supervised by a licensed doctor. In research trials, patients are screened to make sure they don’t have medical conditions that could put them at risk for having a seizure. Patients in the studies are also screened by a psychiatrist to make sure that they in fact are suffering from depression.

Atlanta psychiatrist Mark Hutto has treated about 100 patients with rTMS at his clinic, North Atlanta Psychiatric Associates, since 2001. Hutto says he has patients sign a consent form that explains that the treatment isn’t FDA-approved for depression. He says he also requires patients to undergo physical and psychiatric exams to determine whether they are good candidates.

Hutto, who says he has trained a technician to do the treatment but is in the building when it’s done, wasn’t able to get malpractice insurance for doing rTMS because it isn’t approved for depression. But “I think it’s a very safe procedure,” says Hutto, who uses a Neuronetics device. “I’m not worried about it.”

Hutto says he charges $75 to $150 per session, depending on a patient’s income, since the treatment isn’t covered by insurance. Most patients get 15 to 25 sessions, so their cost is about $1,125 to $3,750, he says. A course of ECT, which is covered by most insurers, can cost more than $12,000, he says.

At the two MindCare clinics in Vancouver and Toronto, almost 400 people have been treated for depression since 2001, about half of whom traveled up from the U.S., says Chief Executive Officer Iain Glass. They charge $4,500 to $6,750 for a three-to-four-week course of treatment and cater to an international clientele by helping to arrange hotel accommodations for patients.

Glass has approval from the Canadian government to sell the device, which has been deemed safe for use. But while there is no rule that says the device cannot be used, neither is there an official sanction of its use in depression by provincial authorities. An Ontario government panel considered the evidence in 2004 and ruled there weren’t yet enough data to warrant the government health system paying for the procedure.

Glass says his technique is very similar to the one used in the Neuronetics study, but he uses a device made by a unit of Medtronic.

The British Columbia College of Physicians and Surgeons, which licenses doctors in the province, says the device doesn’t pose a risk of “direct harm” to patients, according to college registrar Morris Van Andel

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Prescription drug plans not a perfect solution

July 3, 2006

They call it the doughnut hole. It’s more like a black hole that Medicare recipients fall into when their prescription drug benefits come to a screeching halt.

Millions of Americans signed up for prescription drug plans under the new Medicare Part D. They were told they would save lots of money, and in the early going this has been true. Uncle Sam picked up 75 percent of the cost once a $250 deductible was met.

But lots of folks did not realize that once they spent $2,250 on top of their monthly insurance premiums, they would be responsible for 100 percent of their prescription drug bills. Many are once again experiencing sticker shock when they purchase their medicine.

To make things worse, prescription drug prices are rising at an alarming rate. The advocacy organization for older Americans, AARP, recently reported that the cost of brand-name pharmaceuticals is up substantially since the new Medicare Part D drug coverage went into effect in January.

AARP reports that prices have increased by nearly 4 percent during the first quarter. That is considerably more than the inflation rate and represents the steepest increase in brand-name prescription prices in six years.

According to AARP, the popular sleeping aid Ambien jumped more than 13 percent during the first three months of 2006. Lipitor was also up significantly in that same time period. The trade organization for the pharmaceutical industry challenges AARP’s numbers, but another group of consumer advocates called Families USA has reported similar increases.

This is really bad news for senior citizens who hit the doughnut hole in the next several weeks. First, they will have to keep paying their insurance premiums (which can cost $15 to $40 per month, depending on the insurance plan) even though they may get no prescription drug coverage for the rest of the year. Second, they will pay full cost for all their drugs until their total annual drug bill reaches $5,100.

Some Medicare recipients with extra-high drug bills will actually emerge from the doughnut hole before the end of the year. Then they will be covered for roughly 95 percent of their drug costs. Most won’t make it through, however, and will find the next several months taxing on the pocketbook.

Those who are unlikely to get through the doughnut hole may want to consider saving money by purchasing their medicines from Canada. Drugs bought outside the U.S. don’t count toward the total, though, so this is not a good strategy for those who expect to spend more than $5,100 this year.

People who are not eligible for Medicare and lack drug coverage have to pay full cost. With prices skyrocketing, this represents a tremendous burden for millions of Americans.

We have prepared a Guide to Saving Money on Medicine to help people use generic drugs safely and learn more about buying drugs from Canada. Anyone who would like a copy, please send $2 in check or money order with a long (No. 10), stamped (63 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. CA-99, P.O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from our Web site: www.peoplespharmacy.com.

THE PEOPLE’S HERBAL PHARMACY

Q. Instead of sunscreen, I take megadoses of vitamin C, which has protected me for more than 20 years against sunburn. (Of course, I don’t tan or freckle, either.) I take 3 grams of C each day, and once every year or two I might get a little pink on the most sensitive areas (tip of my nose, neck and shoulders early in the summer); otherwise, the C protects me against the radiation of the sun.

A. There is some data to suggest that vitamin C might have some modest effects against ultraviolet radiation. A study published in the Journal of Investigative Dermatology (February 2005) even demonstrated that a combination of antioxidants like vitamin C and E could reduce DNA damage caused by sun exposure.

Do not assume, however, that taking oral vitamins can protect you against harm from the sun’s rays. We would encourage you to stay out of the midday sun and also to use sunblockers that contain titanium dioxide and zinc oxide.

Q. I just read that if you eat black licorice, it can cause high blood pressure. I have low blood pressure and a slow heart rate. Could I take licorice for this problem? Are there any other health concerns associated with licorice?

A. While it is true that natural black licorice (glycyrrhiza) can raise blood pressure, do not try this trick at home! Licorice can deplete the body of potassium and alter hormone levels in the body. In addition to lowering testosterone (and libido), regular licorice consumption can cause muscle cramps, headaches, fatigue and irregular heart rhythms.

Q. I read about your home remedy of white raisins soaked in gin to help arthritis pain. I tried this and found only a moderate improvement in arthritis pain. But after two weeks of treatment I noticed a marked improvement in my restless leg syndrome (RLS).

Have others reported this seeming cure? I used to experience RLS two or three times a week, but have not had a recurrence since beginning the gin/white raisin treatment.

A. You are the first to suggest that gin-soaked raisins might ease restless legs. In this condition, the sufferer often has a creepy-crawly sensation and an uncontrollable urge to move the legs every few seconds. Some people report a deep pain. Most RLS patients report that it interferes with sleep and affects their quality of life.

Prepare this recipe by putting golden raisins in a shallow container and pouring in just enough gin to cover them. Allow the gin to evaporate, and eat nine a day.

More details about the gin-drenched raisin remedy and other approaches to restless legs and arthritis can be found in our Guides to Leg Pain and Home Remedies. Anyone who would like copies, please send $4 in check or money order with a long (No. 10), stamped (63 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. RR-51, P.O. Box 52027, Durham, NC 27717-2027.

Q. Are you aware of any unorthodox uses of gold in treating illness or used as “home remedies”? I’ve heard that wearing gold can ease the discomfort of menstruating women, for example.

A. One unorthodox remedy involves rubbing a gold ring until it is warm and then applying it to a sty on the eyelid. The ancient Romans reportedly used gold salves to treat skin ulcers.

There are also Food and Drug Administration-approved uses for gold. Rheumatologists prescribe gold shots (Myochrysine) or oral gold pills (Ridaura) to treat rheumatoid arthritis.

THE PEOPLE’S PHARMACY

Q. I thought I heard something recently about infants developing eczema from having a cat in the house. Is that true? I have a new granddaughter who shares her home with a 30-pound Maine coon cat. The cat sheds like crazy. Is this a problem?

A. You heard it right, but we can’t say if it will be a problem for your granddaughter. The study tracked 486 babies from birth through one year. At one year, 28 percent of the babies whose families had cats had been diagnosed with eczema, an itchy and uncomfortable rash. In comparison, 18 percent of the feline-free infants had gotten that diagnosis.

Prior research had suggested that pet ownership might help protect children against allergies. That may be true for dogs, but not for cats.

Q. You recently wrote about a pharmacist who refused to dispense the antidepressants Lexapro and Effexor with the pain reliever tramadol. You said this interaction could have led to serotonin syndrome.

I was prescribed Lexapro and tramadol together when I had postpartum depression along with severe migraines. I also took the migraine medicine Imitrex at times.

The results were devastating. For more than a year, I suffered from anxiety, convulsions in parts of my body, memory loss and confusion. At times I felt like I had a stroke because I couldn’t control what my body was doing.

A dozen doctors overlooked the diagnosis of serotonin syndrome, and pharmacists dispensed the medications together without blinking. During the first nine months, I was hospitalized three times for a total of 22 nights. No one could figure out what was making me so ill.

Finally I went off the medicines, but even then it took time for all of the symptoms to go away. Thank you for warning others.

A. When SSRI-type antidepressants such as Celexa, Lexapro, Paxil, Prozac and Zoloft are taken with migraine medicines like Imitrex, Maxalt or Zomig, there is a serious risk of serotonin syndrome. Symptoms of this condition include anxiety, agitation, uncontrollable muscle twitches or contractions, high blood pressure, confusion, convulsions, hallucinations and even coma.

SSRI drugs can trigger serotonin syndrome in combination with a number of other drugs, ranging from antibiotics like Biaxin to pain medicine like tramadol (Ultram). Ask the pharmacist to check on this possibility before taking any other drug with such an antidepressant.

Q. I’ve had trouble with insomnia since entering menopause a few years ago. I wake up several times during the night to go to the bathroom. While I get back to sleep sometimes, on other occasions I lie awake for hours.

I’ve found that Benadryl seems to help. Is there any harm in taking one tablet of Benadryl night after night for years?

A. Diphenhydramine (found in Advil PM, Benadryl, Sominex Original Formula and Tylenol PM) may lose its effectiveness if it is taken night after night. This drug might also make susceptible older people confused, forgetful or unsteady.

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