There is little time to watch TV on the Pharmalot corporate campus, but we were directed to a recent episode of ‘Boston Legal,’ that compelling drama about - what else? - a bunch of emotionally challenged lawyers, because there was mention of a recent pharma issue being investigated by the US Senate Finance Committee.
To wit, the committee is looking at alleged instances of undisclosed conflicts of interests involving academics who receive National Institutes of Health grants to research certain drugs and payments from drugmakers for consulting, research or speaking (back story). This is prominently noted by actress Candace Bergen, along with other matters such as pharma ties to the FDA, Congress and doctors, in a speech to a jury about a woman who suffered a heart attack after taking a drug…
(To watch, please go to this link and click on season 5, episode 6, and skip to about 27 minutes into the program, although it can take awhile to load and you may need to install a plug-in).
Wednesday, October 29, 2008
Apsychiatrist at a behavioral health center in Edison was arrested on Oct. 17 on the belief that he inappropriately touched one of his patients.
The suspect, Chowdhury M. Azam, a 54-year-old Monmouth Junction resident, was charged with criminal sexual contact, a fourth-degree crime. Criminal sexual contact is described in the state legal code as "intentional touching by the victim or actor, either directly or through clothing, of the victim's or actor's intimate parts for the purpose of degrading or humiliating the victim or sexually arousing or sexually gratifying the actor."
The arrest was made the same day the alleged victim filed a report with the Edison Police Department. Following the filing, the Middlesex County Prosecutor's Office Sex Crime/Child Abuse Unit and the Edison Police Department embarked on a joint investigation, eventually leading to Azam's arrest.
Azam has been a licensed psychiatrist with Compass Behavioral Health, located on Pierson Avenue. According to authorities, it is alleged that the psychiatrist inappropriately touched one of his patients on one occasion. The New Jersey State Board of Medical Examiners, the regulatory agency that licenses medical professionals, was informed of Azam's arrest.
According to police, Azam has been released on $50,000 bail set by Municipal Court Judge Craig Coughlin.
Authorities have not released details regarding the alleged victim's age or gender.
Authorities are currently seeking more information about the matter. Anyone with information regarding this investigation, or incidents similar in nature is encouraged to contact Investigator Raj Chopra of the Middlesex County Prosecutor's Office Sex Crimes/Child Abuse Unit at 732-745- 3600, or Detective Michael Michalski of the Edison Police Department at 732-248- 7525 anytime day or night.
Friday, October 24, 2008
As seen in this report from Middlesex County in New Jersey
An Edison psychiatrist has been charged with criminal sexual contact after he allegedly touched one of his patients inappropriately, authorities said Tuesday.
Chowdhury M. Azam, 54, is accused of touching the patient on one occasion and was arrested on Friday, Oct. 17, after the alleged victim reported the incident to Edison police, Middlesex County Prosecutor Bruce Kaplan said in a news release.
The Monmouth Junction resident is a licensed psychiatrist at Compass Behavioral Health on Pierson Avenue in Edison, the prosecutor said.
Edison police received the complaint on Friday and investigated with the Sex Crime and Child Abuse Unit in Kaplan's office before arresting Azam.
Probable cause for the complaint against him was the statement of the alleged victim, Kaplan said. The news release did not specify where and when the alleged incident occurred, nor did it indicate the age of the victim.
Azam was released on $50,000 bail. Kaplan's office said it has notified the New Jersey State Board of Medical Examiners of the arrest.
Reached by phone Tuesday evening, Azam said he had been advised by his attorney not to speak about the case.
"The only thing I can say about this is that I'm not guilty and that this is a false allegation,'' he said. "That's all.''
He referred all other questions to his attorney, Steven D. Altman, who is based in New Brunswick.
Kaplan said anyone with information about this investigation, or similar incidents is encouraged to contact Investigator Raj Chopra of the Middlesex County Prosecutor's Office Sex Crimes/Child Abuse Unit at 732 745-3600, or Detective Michael Michalski of the Edison Police Department at 732-248-7525.
Monday, October 20, 2008
The widow of a former Los Alamos physicist who took an overdose of sleeping pills blames the death on the Santa Fe psychiatrist who treated him, according to a recent lawsuit.
Stanford P. Lyon was pronounced dead on March 7, 2007, two days after he was found unconscious with an empty bottle of Ambien nearby, according to the complaint filed in state District Court Wednesday on behalf of Patricia C. Lyon.
According to the wrongful-death complaint, psychiatrist Will L. MacHendrie began treating Stanford Lyon for depression and bipolar disorder after he took an overdose of Elavil and Triavil and slashed his wrists in early 1986. Lyon was institutionalized twice in 1998, it says.
In early 2007, Stanford "Lyon began to suffer increased anxiety, insomnia, depression and pessimism," the complaint says. It says he saw MacHendrie four times that February to say he was "terrified," unable to sleep and his concentration was "fragmented."
MacHendrie prescribed Ambien, Zyprexa, Symbyax, Cymbalta, Willbutrin and Exelon, the complaint says, but Stanford Lyon told MacHendrie "he desperately wanted to be placed back on Elavil for treatment of his depression."
On Feb. 28, 2007, Stanford Lyon called MacHendrie to say he was having anxiety, insomnia and "burning hands," the complaint says. Over the next few days, it says, Lyon's panic attack continued, and on March 4, 2007, according to MacHendrie's notes, he spent 20 minutes explaining to Lyon how to use the sleeping medications.
The next day, Patricia Lyon found her husband unconscious and without a pulse. The cause of death was determined to be multiple drug toxicity, resulting from a lethal overdose of Ambien and excessive amounts of Elavil, the complaint says.
The complaint says MacHendrie failed to properly assess Stanford Lyon's condition, to recognize he was a suicide risk, to conduct a suicide assessment, to control his intake of medications, to recognize the dangers of the medications, to have him hospitalized and to warn Patricia Lyon about the medications her husband was taking. This means MacHendrie breached his duties and was negligent, "proximately causing Mr. Lyon's death," it says.
Stanford Lyon, who was in his late 60s, was a physicist who worked in weapons design and materials science for Los Alamos National Laboratory, according to online records.
MacHendrie did not respond to a message seeking comment Friday. Santa Fe lawyers Mark Ish and William Winter, who filed the complaint on behalf of Patricia Lyon, seeking unspecified compensatory damages, funeral and burial expenses, also were unavailable for comment.
Saturday, October 18, 2008
Are Antidepressant Drugs Actually Worth Taking? A psychologist says secret corporate documents show how ineffective the drugs really are.
"Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration" by Irving Kirsch et al., published online on February 26 in PLoS Medicine.
Irving Kirsch no longer sends patients to seek out antidepressants. "As a clinical psychologist," he says, "I used to refer patients to colleagues who were psychiatrists to get these medications." But his research over the years has soured him on the drugs, suggesting they work only marginally better in the average patient than a placebo pill. Kirsch recently analyzed the numbers behind a multitude of studies to answer the question: Do
For the analysis, Kirsch and his colleagues were reluctant to rely solely on published drug trials. Those that get published, other researchers have found, tend to show medications in a more positive light than trials that go unpublished. To circumvent that influence, known as "publication bias," Kirsch's team used the Freedom of Information Act (FOIA) to solicit records from the Food and Drug Administration. That gave them access to data from all manufacturer-sponsored trials of the six antidepressants approved between 1987 and 1999—including some trials the manufacturers had never published.
Even then, the data did not reflect everything the researchers would have liked to know. For two of the drugs, for example, there was no indication as to how much the average patient's symptoms improved during treatment. So the researchers ignored those drugs and focused on the other four—fluoxetine (Prozac), paroxetine (Paxil), enlafaxine (Effexor), and nefazodone (formerly sold in the United States as Serzone). In all, they analyzed 35 trials, each of which involved a group of patients who took a placebo and at least one group who took one of those four antidepressants. Kirsch's team considered how sick each group of patients had been before treatment, how much they improved during treatment, and whether they'd gotten a real drug or an inert pill.
Just as one would hope, taking an antidepressant typically improved a person's depressive symptoms, the trials showed. But so did taking a placebo. In fact, the overall difference between medication and placebo was so small that it was "clinically insignificant" for all but the most depressed patients, Kirsch says, a point that was consistent with his past findings. Moreover, antidepressant therapy improved symptoms by the same degree in both mildly and moderately ill patients. "There seems little evidence to support the prescription of
antidepressant medication to any but the most severely depressed patients," says Kirsch, "unless alternative treatments have failed to provide benefit."
In the end, the researchers found that most patients who take antidepressants may glean little from them other than a placebo effect. However, the initial severity of a patient's depression did influence the placebo effect. Placebos seem to help very depressed patients less than they help those with moderate symptoms. As a result, says Kirsch, antidepressants proved substantially more effective than placebos in — and only in — trials involving the most down-and-out patients. Blair Johnson, a social psychologist at the University of Connecticut in Storrs and co-author, recommends that doctors look at all of the alternative therapies—including psychotherapy, exercise, light therapy, omega-3 fatty acid supplements, and various others — first for all but the most depressed patients.
Even if the drugs are effective, you would expect these results because the majority of depressed patients do not get better on the first antidepressant they are prescribed, say numerous critics including members of the pharmaceutical industry and physicians. Darrel Regier, the American Psychiatric Association's director of research, says this is probably why so many patients did not improve significantly. If the unresponsive patients had been tested on two or three antidepressants back-to-back, say critics of this analysis, then more improvement would have been seen.
Moreover, critics say a study like Kirsch's should focus on how many individual patients improve with treatment, not whether the average improvement is clinically significant. By averaging outcomes, the study dilutes some patients' large improvements with others' unchanged symptoms. "That's true," says Kirsch, but if some people improve more than the average, he says, some must improve less—or even be harmed. "Medications have side effects," he says. "One of the side effects [of antidepressants] is increased risk of suicide."
• More prescriptions are dispensed for antidepressants—232.7 million nationwide in 2007—than for drugs of any other type, according to the data firm, IMS Health.
• U.S. sales of antidepressants totaled $11.9 billion in 2007, IMS Health reports.
Sunday, October 05, 2008
One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.
The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.
In one telling example, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from that company — 17 times the figure he had agreed on.
The Congressional inquiry, led by Senator Charles E. Grassley, Republican of Iowa, is systematically asking some of the nation’s leading researchers to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.
“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Mr. Grassley said. “The current system for tracking financial relationships isn’t working.”
The findings suggest that universities are all but incapable of policing their faculty’s conflicts of interest. Almost every major medical school and medical society is now reassessing its relationships with drug and device makers.
“Everyone is concerned,” said Dr. James H. Scully Jr., the president-elect of the Council of Medical Specialty Societies, whose 30 members represent more than 500,000 doctors.
[. . .]
For all his fame in the world of psychiatry, Dr. Nemeroff has faced ethics troubles before. In 2006, he blamed a clerical mix-up for his failing to disclose that he and his co-authors had financial ties to Cyberonics, the maker of a controversial device that they reviewed favorably in a journal he edited.
The Cyberonics paper led to a bitter e-mail exchange between Dr. Nemeroff and Claudia R. Adkison, an associate dean at Emory, according to Congressional records. Dr. Adkison noted that Cyberonics had not only paid Dr. Nemeroff and his co-authors but had also given an unrestricted educational grant to Dr. Nemeroff’s department.
“I can’t believe that anyone in the public or in academia would believe anything except that this paper was a piece of paid marketing,” Dr. Adkison wrote on July 20, 2006.
Two years earlier, unknown to the public, Emory’s conflict of interest committee discovered that Dr. Nemeroff had made more serious blunders, including failing to disclose conflicts of interest in trials of drugs from Merck, Eli Lilly and Johnson & Johnson.
His continuing oversight of a federally financed trial using GlaxoSmithKline medicines led Dr. Adkison to write Dr. Nemeroff on July 15, 2004, that “you must clearly certify on your annual disclosure form that you do not receive more than $10,000 from GSK.”
In a reply dated Aug. 4, Dr. Nemeroff wrote that he had already done so but promised again that “my consulting fees from GSK will be less than $10,000 per year throughout the period of this N.I.H. grant.”
When he sent that letter, Dr. Nemeroff had already earned more than $98,000 that year from GlaxoSmithKline. Three weeks later, he received another $3,844.56 for giving a marketing talk at the Passion Fish Restaurant in Woodbury, N.Y.
From 2000 through 2006, Dr. Nemeroff earned more than $960,000 from GlaxoSmithKline but listed earnings of less than $35,000 for the period on his university disclosure forms, according to Congressional documents.
Sarah Alspach, a GlaxoSmithKline spokeswoman, said via e-mail that “Dr. Nemeroff is a recognized world leader in the field of psychiatry,” and that the company requires its paid speakers to “proactively disclose their financial relationship with GSK, and we believe that healthcare professionals are responsible for making those disclosures.”
Wednesday, October 01, 2008
Psychiatrist faces review in wake of massacre - Hearing to decide competency of Toronto doctor who treated man who killed his wife and children
As seen in the Globe and Mail. Edited for Space
The competency of a Toronto psychiatrist who was treating Chau Huc Minh at the time he massacred his family in 2006 is under scrutiny by the College of Physicians and Surgeons of Ontario.
The College has scheduled a hearing to determine whether the psychiatrist - Dr. Hung-Tat Lo - is competent to continue practising in light of his actions in the Chau case and 15 other unspecified cases.
The main complaint behind the hearing appears to be one lodged last year by Mr. Chau's sister, Jenny Chu. Ms. Chu alleged that Dr. Lo refused her plea to have Mr. Chau sent to a hospital for an assessment and possible treatment on Jan. 6, 2006. Five weeks later - on Feb. 9, 2006 - Mr. Chau used a meat cleaver to inflict fatal injuries on his wife, Shao-Fang, his three-year-old daughter, Vivian, and his five-month-old baby, Ivan.
A CPSO document states that its disciplines committee will decide whether Dr. Lo "failed to maintain the standard of practice and is incompetent in his care and treatment - including, but not limited to - his assessments, diagnoses, treatment and record-keeping, of 15 patients whose identities have been made known to Dr. Lo, between about July, 1983, and July, 2007."
It said the probe will also consider whether Dr. Lo displayed "a lack of knowledge, skill or judgment or disregard for the welfare of his patients of a nature," to the point that his practice should be restricted or terminated.
In the meantime, Dr. Lo has been told to submit sample medical charts and other patient information at least once every two weeks to a doctor appointed by the College to monitor his work.
CPSO spokesman Jill Hefley said in an interview yesterday that a complaint is referred to a disciplines hearing only if there has been a determination that "reasonable and probable cause" exists to believe it may be well founded.
Ms. Chu complained that she told Dr. Lo that her brother's behaviour had grown alarmingly erratic. "I was concerned that he might hurt his two young kids and wife" she said in her complaint. "Therefore, I urged Dr. Lo to send him to hospital with detailed descriptions of his strange behaviour."
Upon leaving Dr. Lo's clinic that day - Jan. 6, 2006 - Ms. Chu claimed that she tried to coax her brother to go straight to the hospital. She said that Mr. Chau became furious, and said: "Even Dr. Lo said that I was okay. Why must you make me go to a hospital?"
Mr. Chau was found not criminally responsible in the killings earlier this week by a Toronto judge.
According to a transcript from Mr. Chau's 2007 preliminary hearing, Dr. Lo denied that Ms. Chu asked him to admit her brother to hospital at the Jan. 6, 2006, meeting. Dr. Lo acknowledged that he saw Mr. Chau for just 140 minutes during the 12 years that he treated him. However, Dr. Lo, who stated he sees 15-20 patients a day, said that he didn't see it as necessary to spend more time with Mr. Chau.
Dr. Lo's office was closed this week, and he did not return telephone messages.
Peter Lindsay, Mr. Chau's defence lawyer, expressed misgivings yesterday about the quality of care his client was given. "The compelling story here is that Dr. Lo sees him so little. If you do the math, he saw him for just over 11 minutes a year. I'm not a doctor, but I think that's far short of what he should be seeing this guy."
Chau Huc Minh was not the first of psychiatrist Hung-Tat Lo's mentally ill patients to explode into violence.
In 2004, two years before Mr. Chau's killing rampage, a 36-year-old Chinese immigrant, Xuan Peng, drowned her four-year-old, autistic baby in a bathtub at her Scarborough home.
She had been under Dr. Lo's care at the time.
According to a 2005 bail ruling that freed Ms. Peng pending her first-degree murder trial, Dr. Lo was treating her for a bipolar disorder at the time that her daughter, Scarlett, drowned.
The presiding judge at the bail hearing was Ontario Superior Court Judge David McCombs.
He was persuaded to grant Ms. Peng bail partly based on testimony from Dr. Lo, who said that she was capable of being managed in the community and agreed to supervise her treatment.
Police arrested Ms. Peng seven months after Scarlett's death. Last March, she was found guilty of second-degree murder, notwithstanding her history of mental illness.