If 100 million Americans have high cholesterol and only 8 million have schizophrenia or bipolar disorder, how can AstraZeneca's Seroquel not cholesterol pill Crestor be its second best selling pill?
Right after its number one pill, the Purple Performer Nexium?
Can anyone say disease mongering?
For years, AstraZeneca has tried to convince depressed people they are really bipolar and need to take the atypical antipsychotic Seroquel (quetiapine fumarate) which is only approved for schizophrenia or bipolar disorder.
"Is It Really Depression or Could It Be Bipolar Disorder?" trumpet the ads, urging unaware victims to take a Symptom Quiz and find out how sick they really are.
Full color spreads run in general interest magazines showing a rampaging woman her mouth contorted--think female Dark Knight--asking readers is this you?
"Are there periods of time when you have racing thoughts? Fly off the handle at little things? Spend out of control? Need less sleep? Feel irritable? You may need treatment for bipolar disorder."
Now the FDA says AstraZeneca can not--repeat not--market Seroquel for depression.
In December the FDA denied approval of Seroquel for major depressive disorder and asked the company instead for more information in a complete response letter (CRL).
Of course to be AstraZeneca's number two pill, Seroquel must be used by more than the nation's schizophrenia and bipolar disorder patients who number only 8 million.
Almost half of Seroquel's 2006 sales were for off label uses says Bloomberg news including depression, autism and hyperactivity in adolescents and dementia, insomnia and Alzheimer's disease in the elderly.
Which wouldn't be so bad if Seroquel were safe.
But AstraZeneca faces nine thousand lawsuits--15,026 plaintiffs-- alleging the company failed to adequately warn patients about Seroquel side effects like severe weight gain, diabetes and pancreatitis.
Even as AstraZeneca vowed to defend the suits on their merits and not capitulate like Lilly with its $1.48 billion settlement with 32 states over similar drug Zyprexa this year, more bad ink spilled.
Documents surfaced in December that showed AstraZeneca knew as far back as 2000 about Seroquel's dangerous side effects at a pretrial hearing in a Tampa, Florida federal court for an upcoming Seroquel trial.
There was "reasonable evidence to suggest Seroquel therapy can cause" diabetes and related conditions wrote Wayne Geller, AstraZeneca's Global Safety Officer after analyzing available studies and internal trials says Bloomberg news.
Created in 1988 and approved for schizophrenia in 1997, Seroquel had an "efficient" journey from R&D to sales.
But in 2005 an article in the New England Journal of Medicine found Seroquel and other atypical antipsychotics except one had no advantage over the older antipsychotics like Haldol and Thorazine. Including the reduction in rigidity and tremors which was sold as their advantage over the old drugs!
The same year, an article in the British Medical Journal found Seroquel and a similar atypical antipsychotic were ineffective in reducing agitation among Alzheimer's patients and actually made cognitive functioning worse.
And in AstraZeneca's own clinical trials, 2.4 percent of people who began treatment with normal blood sugar became technically diabetic after 52 weeks on Seroquel plaintiff lawyer Paul Pennock testified at the Tampa pretrial hearing-- almost a 70 percent increase over those not taking the drug.
Nor can AstraZeneca claim it has marketed Seroquel legally and for approved uses only.
On Thursday, January 3, 2008, an AstraZeneca sales rep "made an unsolicited sales call to a physician at his office" and "stated that Seroquel was approved for treatment of Major Depressive Disorder (MDD)," charges a letter sent to James L. Gaskil, Pharm.D., Director of AstraZeneca's Promotional Regulatory Affairs from FDA Regulatory Review Officer Amy Toscano, Pharm.D. in December.
When the physician asked for written information, the rep sent a mailing with "information about Seroquel and Seroquel XR's use for MDD, and included summaries of eight clinical trials with referenced citations. This mailing was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements," charges the FDA.
AstraZeneca reps were even coached to sell product using the A.A. Milne figures Tigger--bipolar!--and Eeyore--depressed!-- reports the pharma site Pharmalot.
The characterizations could come in handy.
In December AstraZeneca sought approval from the FDA for Nexium for the "overlooked GERD population" of "patients ages 0 to 1 year old."
"While some reflux and regurgitation are normal in infants and may not require medical treatment," says Marta Illueca, MD, AstraZeneca's Nexium Brand Medical Director, "Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants."
They may have bipolar disorder too.
Monday, December 29, 2008
Friday, December 19, 2008
Some children showing up in emergency rooms with overdoses of cough or cold syrup may have been intentionally medicated to keep them quiet, doctors cautioned on Thursday.
An analysis of 189 children who died from medication overdoses showed a significant percentage appeared to have been intentionally overdosed, the doctors reported in the Annals of Emergency Medicine.
"This is a heads up," said Dr. Richard Dart, director of the Rocky Mountain Poison and Drug Center in Denver.
In 79 of the cases, an adult gave the child nonprescription medicine. In 19 cases the adults clearly meant to help the child, but in 26 cases a panel of experts determined the intent was not to treat, Dart said.
He said a panel of experts had to agree that the intent was clear. "They were quite certain in all the cases they decided were intentional," Dart said in a telephone interview.
"We had some cases where the parent poured it into the kid's mouth directly from the bottle," he added.
In October, U.S. makers of over-the-counter cough and cold medications, urged by the U.S. Food and Drug Administration, advised that these drugs should not be used in children under 4 and the FDA is considering requests to ban their use in children under 12.
Dart said complications from accidental misuse are known and dangerous.
"We aren't trying to say there aren't accidents. I am concerned that we have blinders on and we don't want to admit that there is a group of parents who all the warnings in the world won't help because they did it knowingly," he said.
"What we have is a group of adults who want to control the behavior of children and do it in a variety of ways," Dart added.
"Sometimes it is physical violence and sometimes it is drugs. They tend to be lower-income, under-educated parents, often with a history of child abuse or violence in the home. I think there is a clear population here for us to focus on that are involved in these events."
Parents should also be aware that some of the adults who gave the medications to the children were day-care providers who probably were not malevolent in their actions but simply overwhelmed and looking for a way to quiet down their charges, Dart said.
An estimated 4 million children under the age of 12 are treated with over-the-counter cough and cold products each week in the United States.
Saturday, December 13, 2008
A drug company is a commercial business whose focus is to research, develop, market and/or distribute drugs, most commonly in the context of healthcare; from wikipedia. But according to a study by two York University researchers estimates the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry’s claim.
But how could this be you might ask yourself. Well the answer is fairly easy; regardless of its purpose of helping people it is a bussiness and thus it has to make money and the way of making money is by advertising more and researching less. The researchers’ estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales of US$235.4 billion.
In case you are wondering who made this study well the research is co-authored by PhD candidate Marc-André Gagnon, who led the study and Joel Lexchin, a long-time researcher of pharmaceutical promotion, Toronto physician, and Associate Chair of York’s School of Health Policy & Management in the Faculty of Health.“In our paper, we make the case for the need for a new estimate of promotional expenditures by the U.S. pharmaceutical industry,” says Gagnon. “We then explain how we used proprietary databases to construct a revised estimate and finally, we compare our results with those from other data sources to argue in favor of changing the priorities of the industry.”
This study is very important as it shows the most accurate image yet of the promotional workings of the pharmaceutical industry, says Lexchin. But even this could be wrong a bit because there are other advertising campaigns which could not be taken into consideration such as ghost-writing and off-label promotion so in fact these companies are probably spending more than twice advertising rather then researching. As well, note the authors, the number of meetings for promotional purposes has dramatically increased in the U.S. pharmaceutical industry, jumping from 120,000 in 1998 to 371,000 in 2004, further supporting their findings that the U.S. pharmaceutical industry is marketing-driven.
Tuesday, December 09, 2008
Local officials in Shandong Province have apparently found a cost-effective way to deal with gadflies, whistle-blowers and all manner of muckraking citizens who dare to challenge the authorities: dispatch them to the local psychiatric hospital.
In an investigative report published Monday by a state-owned newspaper, public security officials in the city of Xintai in Shandong Province were said to have been institutionalizing residents who persist in their personal campaigns to expose corruption or the unfair seizure of their property. Some people said they were committed for up to two years, and several of those interviewed said they were forcibly medicated.
The article, in The Beijing News, said most inmates were released after they agreed to give up their causes.
Sun Fawu, 57, a farmer seeking compensation for land spoiled by a coal-mining operation, said he was seized by local authorities on his way to petition the central government in Beijing and taken to the Xintai Mental Health Center in October.
During a 20-day stay, he said, he was lashed to a bed, forced to take pills and given injections that made him numb and woozy. According to the paper, when he told the doctor he was a petitioner, not mentally ill, the doctor said: “I don’t care if you’re sick or not. As long as you are sent by the township government, I’ll treat you as a mental patient.”
In an interview with the newspaper, the hospital’s director, Wu Yuzhu, acknowledged that some of the 18 patients brought there by the police in recent years were not deranged, but he said that he had no choice but to take them in. “The hospital also had its misgivings,” he said.
Xintai officials do not see any shame in the tactic, and they boasted that hospitalizing people they characterized as troublemakers saved money that would have been spent chasing them to Beijing. There is another reason to stop petitioners who seek redress from higher levels of government: they can prove embarrassing to local officials, especially if they make it to Beijing.
The Xintai government Web site noted that provincial authorities had recently referred to Xintai as “an advanced city in building a safe Shandong.” They said that from January to May this year, the number of petitioners who went over the heads of local authorities was 274, a 4 percent drop from the same period in 2007. Although China is not known for the kind of systematic abuse of psychiatry that occurred in the Soviet Union, human rights advocates say forced institutionalizations are not uncommon in smaller cities. Robin Munro, the research director of China Labor Bulletin, a rights organization in Hong Kong, said such “an kang” wards — Chinese for peace and health — were a convenient and effective means of dealing with pesky dissidents.
“Once a detainee has been officially diagnosed as dangerously mentally ill, they’re immediately taken out of the criminal justice system and they lose all legal rights,” said Mr. Munro, who has researched China’s practice of psychiatric detention.
In recent years practitioners of Falun Gong, the banned spiritual movement, have complained of what they call coerced hospitalizations. One of China’s best-known dissidents, Wang Wanxing, spent 13 years in a police-run psychiatric institution under conditions he later described as abusive.
In one recent, well-publicized case, Wang Jingmei, the mother of a man convicted of killing six policemen in Shanghai, was held incommunicado at a mental hospital for five months and released only days before her son was executed in late November.
The article in The Beijing News about the hospitalizations in Xintai was notable for the attention it gained in China’s constrained state-run media. Such Communist Party stalwarts as People’s Daily and the Xinhua news agency republished the article, and it was picked up by scores of Web sites. At Sina.com, the country’s most popular portal, the report ranked as the fifth most-viewed news headline, and readers posted more than 23,000 comments by evening. The indignation expressed was universal, with many clamoring for the dismissal of those involved. “They’re no different from animals,” read one post. “No, they’re worse.”
By Monday evening, the Xintai city government was rejecting the report by The Beijing News as reckless and slanted. In a telephone interview broadcast on Shandong provincial television, an unidentified municipal official suggested that those confined to the mental hospital had gone mad from their single-minded quest for justice. “There are some people who have been petitioning for years and become mentally aggravated,” the official said.
Reached by phone on Monday, a hospital employee said Mr. Wu, the hospital director who voiced his misgivings to The Beijing News, was unavailable. The employee, Hu Peng, said that officials from the local government had taken him away for “a meeting” earlier in the day.
Although he would not provide a reporter with contact information for the former patients, Mr. Hu defended the hospitalizations, saying that all those delivered by the Public Security Bureau were sick. He added that the hospital was not authorized to provide a diagnosis to the patients, only to treat them. “We definitely would not accept those without mental problems,” he said.