Sunday, January 29, 2012
Saturday, January 28, 2012
A father’s anguish: Military killed my son with prescription pad | The Daily Caller
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A generic photo of prescription drugs taken March 20, 2009 for files. (PAUL J. RICHARDS/AFP/Getty Images)A father who has lost two sons to war told The Daily Caller that the U.S. Central Command’s policy of allowing troops to deploy with a 180-day supply of the antipsychotic Seroquel has contributed to the deaths of troops and veterans. Seroquel, he said, has tragic side effects that military leaders have ignored in their quest to combat insomnia and post-traumatic stress disorder (PTSD) among fighting men and women.
The father, West Virginia school principal Stan White, said there are better ways to treat troops and veterans who suffer from PTSD. But because the maker of Seroquel, London-based AstraZeneca, has so much influence over Congress and the military, he insisted, that peer counseling and other treatment options are being shoved aside in favor of low doses of the drug.
White’s suspicions are slowly being validated by a series of studies, legal settlements, and military rulings — including a recommendation from the Department of Defense’s own advisory body on pharmaceuticals.
“I think AstraZeneca is so strong and has so much power that no one can speak out,” said White, who has remained stoic despite his losses. “Money talks. I truly believe AstraZeneca and other big pharma companies have control over Congress.”
His first son, Army Sgt. Robert White, died in combat in Iraq. When Robert’s younger brother Andrew returned from his own tour in the Middle Eastern country, a Veterans Administration doctor prescribed a combination of Seroquel and antidepressants for his PTSD.
Andrew died at home, and the state of West Virginia ruled that an accidental medication overdose was to blame.
But his father believes the “dangerous” pill cocktail killed him. And he told TheDC that he has identified 300 other soldiers and veterans who died from sudden cardiac arrest while taking Seroquel and antidepressants in combination.
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Evidence supporting his theory has continued to accumulate, including a September 2011 study from the European Society of Cardiology which linked the “combined use of antipsychotic and antidepressant drugs” with an increased risk of sudden heart attacks.
Seroquel has been on the market since 1997, and in that time doctors have widely experimented with prescribing it for “off-label” purposes that the FDA has not approved. The drug, a mood stabilizer, is approved to treat schizophrenia and bipolar disorder, but it has also been used to treat insomnia in Parkinson’s disease patients, dementia in adults of all ages, and a variety of disorders in children.
Doctors have free rein to prescribe medications for off-label uses, and the FDA’s ever-growing avalanche of advisories sometimes makes it difficult for physicians to know what has been approved and what has not.
A 2009 University of Chicago national survey of physicians, for instance, found that one in eight doctors thought Seroquel was approved for treating dementia, even though the FDA had issued a specific warning against it.
Drug marketers, however, are forbidden to promote their products for any purpose not approved by the FDA.
In April 2010 AstraZeneca conceded that it had crossed that line, agreeing to pay the U.S. government $520 million to settle claims related to its illegal promotion of Seroquel for off-label uses.
NEXT: A massive increase in government spending on Seroquel
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Bydureon, a Diabetes Drug from Amylin, Wins F.D.A. Approval - NYTimes.com
Analysts expect annual sales of Bydureon to eventually exceed $1 billion. But they are less enthusiastic than they once were, in part because of safety concerns involving thyroid cancer and pancreatitis.
David Kliff, publisher of Diabetic Investor, an electronic newsletter following the diabetes industry, said a once-weekly self-injection could make Bydureon an alternative for many patients to multiple insulin injections or even to multiple pills every day.
Friday, January 27, 2012
Harvard doctor calls for greater supplement regulation in NEJM | Drug Store News
WASHINGTON — The New England Journal of Medicine on Thursday published an opinion online that called for more rulemaking to govern dietary supplements in an effort to reign in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.
Author Pieter Cohen, author of the opinion and an assistant professor of medicine at Harvard Medical School, in his opening paragraph pointed to the recent recall of the product Zotrex. Marketed as a dietary supplement, the product reportedly contained the fictitious ingredient "Ophioglossum polyphyllous," but in actuality contained a drug analogue of the active ingredient in the erectile dysfunction pharmaceutical Viagra (sildenafil).
Following a Food and Drug Administration investigation of NovaCare, the company that distributed that product online, the U.S. Attorney's Office in September 2011 revealed a 31-count indictment alleging NovaCare proprietor Kelly Dean Harvey purposefully thwarted FDA regulations after the agency first started warning consumers about NovaCare products in 2009 (the product at the time was called "Stiff Nights"). Charges against Harvey include one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud and nine counts of money laundering, according to reports. He pleaded not guilty to those charges in November.
"Although Zotrex represented a particularly brazen violation of the law," wrote Cohen, an assistant professor of medicine at Harvard Medical School in the opening paragraph, "surprisingly, many new supplement ingredients are introduced into the market as [those found in Zotrex were], without any regulatory oversight." Specifically, Cohen calls for clinical trials establishing safety be a pre-requisite for new dietary ingredients to reach the market.
James Murdoch’s departure rings in changes to GSK’s board | InPharm
GlaxoSmithKline has announced that after nine years with the firm, Sir Crispin Davis, Sir Robert Wilson and Larry Culp will stand down from the board.
In addition, the UK firm said that James Murdoch has decided not to stand for re-election.
Sir Christopher Gent, chairman of GSK, said: “James Murdoch has decided to stand down from the board with effect from this year’s AGM.
MeReC Bulletin – Implementing key therapeutic topics: 1
The National Prescribing Centre has published a MeReC Bulletin (PDF), the first in a series of three, that focuses on the therapeutic areas of the QIPP agenda.
The topics covered in this bulletin are:
- Non-steroidal anti-inflammatory drugs
- Antibiotic prescribing - especially quinolones and cephalosporins
- High dose inhaled corticosteroids in asthma
For each of the therapeutic topic areas the evidence base is summarised and current prescribing data are reviewed.
EDITORIAL Of doctors and drug makers - latimes.com
Did your doctor prescribe that expensive drug solely because you need it, or in part because she has friendly feelings toward the pharmaceutical company that makes it, which treated her to a Hawaiian vacation-cum-"medical conference"? Patients may get some insight into such questions thanks to a lesser-known but important provision of the 2010 healthcare reform law that requires the makers of drugs and medical devices to disclose most payments and gifts to physicians.
The proposed regulations, which are going through a period of public comment, are appropriately strict in ways that would both protect patients and reduce medical costs. The payments and gifts would be available on a searchable public website. Free samples of drugs would be exempt from reporting, but otherwise, anything worth more than $10 total for the year would have to be disclosed.
Of course, many doctors are motivated only by the well-being of their patients, and there are times when drug company payments are appropriate and beneficial to medical research. But pharmaceutical companies are known for underwriting luxurious medical meetings for doctors that are more about play than work, and for paying physicians hefty sums to pitch their drugs to colleagues, often at lunches also paid for by the companies. Doctors with the best intentions can be influenced, consciously or not, by relentless marketing, especially when it's done by their peers.
Physicians who received research funding and other payments from pharmaceutical companies have sat on advisory boards for the U.S. Food and Drug Administrationand have recommended drugs made by those companies. A survey published in the Annals of Internal Medicine in 2010 found that 71% of doctors had accepted food from drug companies, and that doctors who took payments were more likely to prescribe those companies' expensive brand-name medications rather than cheaper generics. Fourteen percent of doctors had been paid to serve on advisory boards and enroll patients in clinical trials — and that number was half what it had been in 2004, before the practice came under greater scrutiny. Some drug companies recently began voluntarily reporting payments and gifts to doctors.
In other words, the website will be a force for good even if few patients examine it. Watchdog organizations and news reporters will use it. For many doctors and pharmaceutical companies, the knowledge that their actions will be held up to public light is enough to curb the potentially troubling behavior.
Thursday, January 26, 2012
BBC News - Bid to stop doctor gagging orders
Doctors are being told they can no longer sign contracts that contain gagging orders, in new guidance issued by the medical regulator.
The General Medical Council advice states medics should not enter contracts or deals that seek to stop them raising concerns about poor care.
The guidance also makes clear that doctors have a duty to act if they believe care is being compromised.
It is the latest in a series of attempts to encourage whistle-blowing.
Evidence has been emerging in recent years of trusts restricting the ability of staff to raise the alarm about bad practices.
Forget sponsorship and free trips—welcome to Pharmacare | BMJ
Ray Moynihan, author, journalist and conjoint lecturer, University of Newcastle, Australia
Tales From the PMPCA contd. - The Case of the Botox Tweet
An anonymous, non-contactable complainant alleged that a tweet sent by an Allergan employee to a patient organisation and an individual representing that organisation was in breach of the Code. The tweet referred to Botox and stated ‘… we could do something around stroke rehab …’. Botox was indicated, inter alia, for certain spasticity associated with stroke in adults.
The detailed response from Allergan is given below.
The Panel noted Allergan’s submission that its employee had used a personal Twitter account to respond to a tweet from a friend who worked for an agency that worked for the patient organisation. The tweet referred to Botox and rehabilitation in stroke. The Panel noted that although the tweet was intended to be a private message to a friend, tweets were much more public and so in that regard it considered that a prescription only medicine had been advertised to the public. A breach of the Code was ruled as acknowledged by Allergan. High standards had not been maintained. A further breach of the Code was ruled.
The Panel noted that the tweet was sent in error by an individual using a personal account and without the knowledge or authority of Allergan. Pharmaceutical company employees needed to ensure that business relationships and personal relationships were kept very separate particularly when such business relationships were subject to the Code. In the Panel’s view pharmaceutical company employees needed to be extremely cautious when using social media. Allergan’s company policy clearly stated no Allergan employee might comment in a social media forum about an Allergan product or business activity. The Panel thus noted that Allergan had a policy in place which should have prevented the tweet being sent. The Panel considered that Allergan had been badly let down by its employee. Nonetheless the Panel did not consider that this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. No breach of that clause was ruled.
Risperdal Whistleblower: J&J Credo Is ‘Empty Words’ // Pharmalot
Last week, Johnson & Johnson agreed to pay $158 million to settle a lawsuit filed by the Texas attorney general, who charged the health care giant had orchestrated a controversial program that was designed to boost the use of the Risperdal antipsychotic in the public sector throughout the country (back story). The charges stemmed from a whistleblower lawsuit filed in 2004 by a Pennsylvania state investigator named Allen Jones, who uncovered the program, known as the Texas Medication Algorithm Project. J&J had been accused of surreptitiously creating and funding TMAP, and relied on various state officials and academics to develop and sell the program as a policy tool. Jones was fired for his trouble, but his efforts laid the groundwork for numerous federal and state investigations - J&J has reportedly reached a tentative deal to pay up to $1 billion to settle a federal probe into Risperdal marketing and resolve civil charges, and also agreed to a misdemeanor charge over the same issues. We spoke to Jones, a 57-year-old who divides his time between litigation consulting and stone masonry, about the recent trial and what this has meant…
Wednesday, January 25, 2012
U.S. settles with drugmaker Ranbaxy over violations | Reuters
) to resolve the company's manufacturing violations.(Reuters) - The U.S. Department of Justice said it had reached an agreement with generic drugmaker Ranbaxy Laboratories Ltd (RANB.NS
The United States said Ranbaxy had "numerous problems" at its facilities in the United States and in India, such as not keeping written records and not preventing contamination of sterile drugs.
The government also said Ranbaxy submitted false data in applications to the Food and Drug Administration.
Ranbaxy cannot manufacture drugs for the U.S. market at some of its facilities until it resolves the problems, the government said.
Ranbaxy originally announced the agreement with the U.S. government in December but did not provide details about its violations. It set aside $500 million for any liabilities related to the case.
Abbott to cut 700 jobs, most in Chicago area - Chicago Sun-Times
Medical device and drugmaker Abbott Laboratories says it will lay off 700 employees, most in the Chicago area, as part of ongoing restructuring efforts in its medical device and diagnostic businesses.
A company spokeswoman says most of the layoffs involve employees who manufacture the company’s heart stents and diagnostic tests. Abbott expects a decline in orders for stents later this year after the expiration of a supply agreement with medical device maker Boston Scientific Corp. Abbott currently sells a version of its Xience stent to Boston Scientific, which pays a 40 percent royalty on sales. Boston Scientific recently replaced that device with its own in-house stent, Promus Element.
About 500 of the eliminated positions are related to stents, with the remaining 200 from the company’s diagnostic business.