The Veterans Affairs Department continues to issue contracts to purchase an anti-psychotic drug to treat post-traumatic stress disorder despite research showing the drug, risperidone, is no more effective than a placebo.
Nextgov reported Aug. 22 that VA spent $717 million over the past decade to purchase risperidone, the generic name for Risperdal, a second-generation anti-psychotic drug originally developed by the Janssen Pharmaceuticals division of Johnson & Johnson to treat severe mental conditions such as schizophrenia and bipolar disorder.
VA doctors prescribe the drug to treat PTSD, but a study by department researchers published Aug. 2 in the Journal of the American Medical Association concluded, "treatment with risperidone compared with placebo did not reduce PTSD symptoms."
Despite these findings, on Aug. 11, VA awarded a contract to Mylan Pharmaceuticals Inc. for more than 200,000 bottles of risperidone containing more than 20 million pills in multiple dosages. The announcement of the contract to the Morgantown, W.V., generic drug manufacturer did not provide a dollar value for the contract.
The Defense Department, Indian Health Service and Bureau of Prisons also can order off the Mylan contract, which has four option years.
The contract with Mylan is just one of more than 90 Federal Supply Schedule contracts for risperidone that VA has with other generic drug manufacturers and Janssen, according to the department's online pharmaceutical catalog.
The Food and Drug Administration has approved risperidone only for treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in children and adolescents, but clinicians can prescribe it for other conditions, a practice known as "off-label" use.
Janssen is under investigations by the Justice Department and several state attorneys general for its sales and marketing practices regarding Risperdal, according to Johnson & Johnson's quarterly report filed July 3 with the Securities and Exchange Commission.
A 2007 paper by two VA doctors who examined the marketing of second-generation anti-psychotic drugs provides insight into sales practices that contribute to such drugs' off-label use.
The paper, co-authored by Dr. Robert Rosenheck, a psychiatrist at the West Haven, Conn., VA medical center, reported that 639 department psychiatrists who responded to a Web survey said they were contacted an average of 14 times per year by pharmaceutical sales representatives, and were invited to attend continuing medical education seminars conducted by the companies.
Rosenheck, who also co-authored the Aug. 2 study on risperidone, reported that only half the assertions made by pharmaceutical sales representatives were consistent with FDA-approved labeling. "These findings suggest that there have been substantial discrepancies between information clinicians report having received in their contacts with industry representatives and FDA-approved information," he wrote.
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Wednesday, August 31, 2011
VA awards new contract for debunked PTSD drug - Nextgov
Consumer groups: Stop sale of J&J breast implants | Reuters
(Reuters) - Consumer advocates asked health regulators to take silicone breast implants made by Johnson & Johnson off the market because the company has not been able to provide enough long-term safety data.
The groups spoke on Tuesday at a two-day Food and Drug Administration advisory panel meeting to discuss follow-up safety studies for silicone implants that have already been approved for sale. The FDA said the issue of product removal was not under consideration during the meeting.
Tuesday, August 30, 2011
AstraZeneca reveals payments to US doctors - Yahoo! UK & Ireland Finance
AstraZeneca (LSE: AZN.L - news) will for the first time disclose the multi-million dollar payments it makes to American doctors for meals, travel and clinical research in an effort to be more transparent about its relationship with physicians.
The Anglo-Swedish drug maker already discloses how much it pays to US doctors who speak on behalf of the company and its products, but it last week launched a searchable database detailing other payments made to doctors and institutions, such as compensation for carrying out clinical research.
Astra's move comes as drug companies are gearing up to make similar disclosures in Britain. Earlier this year, the ABPI the UK's pharmaceutical industry trade body changed its code of practice to ensure that from next year onwards, payments made to healthcare professionals for services such as speaking and consultancy will be declared.
Astra said that it supported the ABPI's approach and was evaluating how these payments could be reported. Fellow drug maker, GlaxoSmithKline (Other OTC: GLAXF.PK - news) , added that it had committed to reporting these payments and the first disclosures would begin in 2013 for payments made in 2012.
Figures disclosed by Astra for payments in the US show that a total of $24.7m (£15m) was paid out in the second quarter of 2011, representing $8.1m in payments to physicians and $16.6m paid to institutions.
Those figures come as a report yesterday suggested that a dozen leading drug makers had paid doctors in the US more than $150m so far this year.
Marie Martino, Astra's US compliance officer, said the company's new reporting "expands on a major initiative announced three years ago to provide greater public visibility into how we do business".
She (SNP: ^SHEY - news) added that Astra paid doctors as the company collaborates with them to educate professionals about the safety and efficacy of its medicines, and engages with them to carry out research.
As well as fees for working on clinical trials, speaking, or consulting, she said the company reimburses reasonable meal and travel expenses incurred in connection with those services.
Pharmaceutical companies have been bowing to pressure for greater transparency following concerns in the US about commercial links between industry and health care professionals.
Earlier this year, Glaxo disclosed for the first time how much it paid for clinical research studies carried out in the US.
Astra has also stopped paying for clinicians to attend international medical and scientific meetings.
Monday, August 29, 2011
Why the Fukushima disaster is worse than Chernobyl - - The Independent
Japan has been slow to admit the scale of the meltdown. But now the truth is coming out. David McNeill reports from Soma City.
High Chocolate Consumption May Reduce Heart Disease Risk By One Third
Consuming lots of chocolate appears to reduce the risk of developing heart disease by one third, researchers from the University of Cambridge, England reported in the BMJ (British Medical Journal) and the European Society of Cardiology Congress in Paris, France.
Pharma groups pay millions to US doctors - Andrew Jack FT
A dozen leading pharmaceutical companies have paid doctors in the US more than $150m so far this year, according to data that will intensify scrutiny over the lack of transparency around hotly debated marketing and support practices.
Sunday, August 28, 2011
Johnson & Johnson sued over mouthwash cancer fears | World news | The Observer
A company that makes an oral cancer detection kit has launched a $60m lawsuit against Johnson & Johnson, claiming that the multinational prevented its product from being sold to protect its own Listerine mouthwash, which, along with other mouth rinses, has been linked to mouth cancer.
Saturday, August 27, 2011
Friday, August 26, 2011
Merck Wins Reversal of $32 Million Vioxx Jury Award in Texas Supreme Court - Bloomberg
Merck & Co. doesn’t have to pay a $32 million jury award to the family of former user of the company’s Vioxx painkiller who died of a heart attack, the Texas Supreme Court ruled.
The court today said the family of Leonel Garza didn’t produce adequate evidence showing Vioxx caused the heart attack, meaning the 2006 verdict must be thrown out. Merck, the second biggest U.S. drugmaker, agreed in 2007 to pay $4.85 billion to settle thousands of injury claims over the drug.
Lawyers for the Garzas “did not present reliable evidence of general causation and therefore are not entitled to recover against Merck,” the state’s highest court concluded in an 18- page decision.
Kathy Snapka, one of the Garza family’s lawyers, didn’t immediately return a phone call or e-mail seeking comment on the Supreme Court ruling.
Officials of Whitehouse Station, New Jersey-based Merck pulled Vioxx off the market in 2004 after researchers linked it to an increased risk of heart attack and stroke. Former users also criticized the company for downplaying the drug’s health risks and manipulating studies to help promote the drug.
Merck officials countered that Vioxx wasn’t the cause of users’ heart attacks and that the company had properly warned doctors and consumers about the painkiller’s risks.
Trial Record
Merck won 11 of the 16 cases over Vioxx that went to trial starting in 2005. Under the November 2007 settlement, Merck excluded some of cases it lost, including Garza’s, from being included under the accord.
A jury in Rio Grande City, Texas, ruled in April 2006 that Merck failed to warn doctors of Vioxx’s risks and that the drug caused the fatal heart attack of Garza, 71, in 2001. The jury awarded $32 million to Garza’s widow, which Judge Alex Gabert cut to $8.73 million because of a state cap on punitive damages.
“Today’s decision reaffirms that there is simply no reliable scientific evidence that Vioxx caused” Garza’s heart attack, Ted Mayer, a lawyer for Merck, said in an e-mailed statement.
The case is Garza v. Merck & Co., 03-84, 229th Judicial District Court, Starr County, Texas (Rio Grande City).
To contact the reporter on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.
PLoS Medicine: Being the Ghost in the Machine: A Medical Ghostwriter's Personal View by Linda Logdberg
Introduction Top
Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.
What I Did Top
In line with the description on the American Medical Writers' Association Web site about what medical writers do [1], I wrote slide kits, monographs, executive summaries, journal articles, backgrounders, newsletters, competitive analyses, publication plans, video scripts, audio scripts, and continuing medical education (CME) programs for physicians and nurses. Each piece (“job”, in advertisingspeak) was born out of the publications planning strategy developed for a fee by the medical education (meded) company for the pharmaceutical corporation.
Medical writers are highly deadline-driven. For one hormone patch product I worked on, writers and “creatives” were asked to remain at work until close to midnight to await results from physician focus groups on the West Coast. After receiving the client's (i.e., pharma's) take on the focus group results for that day, we rewrote the messages for the next day's groups and sent them to the West Coast. A slide rose or fell on subtleties: in one slide kit draft in my files, an account executive added “Importance of early intervention” to a slide titled “Chronic Pain.” The bullet does not help define chronic pain, but it plants the idea that treatment should be started ASAP in the mind of the listener. Clients admonished us to always distinguish between “adverse effects” (for competitors' products: Drug X could have caused the heart attack) and adverse events (our product: some patients taking Drug X just happened to have a heart attack).
Ghostwriting was a small, but real, part of my duties. I have seen published pieces that are virtually identical to the final drafts I submitted. Regardless of what I wrote, though, for many years I considered my role to be similar to that of a highly paid technician and did not question its ethics.
Why I Did It Top
My background may not have been typical for a medical writer, but neither was it uncommon. I enjoyed a research career up to the point where I no longer enjoyed it, which came a few years after receiving my PhD. Several things about an academic career did not encourage me to continue, although I loved research and working in the lab. These included the difficulty of getting tenure and the possibility of finding myself unemployed in my mid-40s: there were 12 newly hired assistant professors in the department where I did my second postdoc, with an average time to tenure of more than 10 years.
Ironically, though, it was the ethics of authorship that sent me fleeing academia. I ran afoul of a colleague in my last research position, who assumed that postdocs would draft his grant renewal application. I commented offhandedly one day, “Well, I for one would never write something and have someone else sign his name to it—that would be unethical.” Dr. X told me that that was when he realized that it would not work out for me to continue there, as my attitude was unacceptably insubordinate. Faced with the need for a job, I resigned and answered an ad in The New York Times for a company that needed medical writers. This began a series of freelance and in-house jobs with a range of medical communications companies.
I believe that many of the factors that kept me in medical writing apply to most medical writers. First, I believed that I was helping people: sick people need drugs, and physicians need to know about those drugs to prescribe them appropriately. Second, I had young children and valued the flexibility of working at home, which most meded companies offered at least part of the time. Third, the work was interesting: I interacted with top researchers and was assured of an ease of access that I never would have had as an assistant professor. Fourth, the money was good. Really good, especially compared with the typical assistant professor salary. And perhaps most important in the longer run—it was fun. Traveling, eating in high-end restaurants, wearing fashionable clothes, and rushing to meet important deadlines—what's not to like?
Why I Stopped Doing It Top
It turned out, there was quite a bit not to like. I'd started in smaller companies headed by PhDs or MD/PhDs who dealt directly with the primary researchers and the pharmaceutical companies. There were no advertising types in sight, and I had frequent, direct communication with the physician-authors. I saw my role as helping a busy researcher write up research results: he or she did the research (which I'd already decided I didn't want to do), and I got to analyze and describe it.
But as my career developed, several of these smaller firms went out of business, and I began to get more work from larger meded companies that were part of large advertising agencies. The bigger the agency, the more likely it was that my contact person was someone without a science background. In the worst of these settings, I discussed projects only with the program manager and had limited—or no—access to the “author.”
The work itself began to lose its charm. My preferred area of interest was oncology, and the lighter-weight assignments that increasingly came my way were not as interesting. It was hard to muster up much enthusiasm for the importance of treating, say, subclinical hypothyroidism—indeed, subclinical anything. In addition, the ethical issues began to tap me on the shoulder: perhaps the most memorable example of this was a contraceptive product that caused severe, unpredictable vaginal bleeding in some women. My job was to draft a monograph that would profile the product's benefits, one of which, according to the client, was that although the bleeding could be severe, it was at least something that women could anticipate. In other words—the bad news is that a meteorite will strike you, but the good news is—a meteorite will strike you!
This kind of doublespeak became more and more troubling, and my career came to an end over a job involving revising a manuscript supporting the use of a drug for attention deficit-hyperactivity disorder (ADHD), with a duration of action that fell between that of shorter- and longer-acting formulations. However, I have two children with ADHD, and I failed to see the benefit of a drug that would wear off right at suppertime, rather than a few hours before or a few hours after. Suppertime is a time in ADHD households when tempers and homework arguments are often at their worst. So I questioned the account executive at the large agency that had hired me. In particular, I wanted to ask the physician author their view of the drug's benefits. Attempts to discuss my misgivings with the meded contact met with the curt admonition to “just write it.” But perhaps because this particular disorder was so close to home, I was unwilling to turn this ugly duckling of a “me-too” drug into a marketable swan.
I decided it was time to burn my medical writing bridges and contacted The New York Times, which coincidentally had planned an investigative article on pharmaceutical marketing to physicians. I was interviewed for this article, written by Melody Petersen, by Ms. Petersen and Walt Bogdanich [2]. Shortly after its publication (November 22, 2002; page A1), I received a polite letter from an executive of the meded company asking for all the materials back and reminding me of my confidentiality agreement. I also received a direct threat of legal retaliation in a phone call from my former contact at that agency.
What I Think Now Top
Wordsmithing is ubiquitous in all promotional writing, not just ghostwriting: it's the name of the game. Yet advertising masquerading as unbiased health information clearly threatens the fundamental assumptions of scientific research. Can pharma, clinicians, researchers, and consumer protection advocates work together without distortion?
I believe that they can. A system could be put in place that fortuitously addresses another critical problem—the underemployment of medical writers, who, possessing academic training and experience without opportunities to use them, are “all dressed up” intellectually with no place to go. All too often, people like me find themselves unemployed or in science-related positions such as teaching that offer little hope of advancement in a job market that has not added new jobs in biomedicine in 20 years despite a doubling in the number of PhDs in that field [3].
If research centers that employ people who serve as “guest authors” (often the same places that accredit CME programs funded by pharmaceutical money) were, in addition, to employ medical writers, much could be accomplished toward cleaning up the ethics of authorship. Funds to pay medical writers and editors could be given to these centers by pharmaceutical companies, allowing the writers to work directly with researchers. The pharmaceutical company's role would be limited to factchecking the document and clarifying issues about dosage, adverse events, postmarketing developments, etc., and the final product would be submitted for peer review by the researcher personally. The incentive for the pharmaceutical company would be to educate and inform physicians and researchers, pure and simple. Drug promotion would still occur, but would be in the hands of advertising agencies.
This approach would eliminate the meded companies, currently “the middleman” between pharma and physician. It would reduce the need for journals to take on the entire responsibility of vetting submitted manuscripts for conflicts of interest related to authorship, because the academic institution that employed the researcher-author would have a stake in ensuring the paper's accuracy as well as in exposing conflicts of interest. The increased visibility to the research community of the pharmaceutical company could reduce the likelihood of unfounded claims or egregious promotion of off-label use. This arrangement could shorten the interval between research and publication, and ensure a high quality of publications. Finally, one other stakeholder would surely be well pleased by such an arrangement—the medical writer, who would be glad to once again work in an academic environment.
Acknowledgments Top
This paper is based upon a presentation given by the author at a conference on the Ethics of Ghost Authorship in Biomedical Research: Concerns and Remedies, University of Toronto, May 4, 2011.
Author Contributions Top
Wrote the first draft of the manuscript: LL. Contributed to the writing of the manuscript: LL. ICMJE criteria for authorship read and met: LL. Agree with manuscript’s results and conclusions: LL.
References Top
- (2010) Medical communication: a branch of the technical communication tree. Intercom. Available: http://www.amwa.org/default/prof.devo/stc.medicalcommunication.2010.05.pdf. Accessed 8 July 2011.
- (22 November 2002) Madison Ave.has growing role in the business of drugresearch. The New York Times; A1. Available: http://www.nytimes.com/2002/11/22/business/madison-ave-has-growing-role-in-the-business-of-drug-research.html?src=pm. Accessed 13 July 2011.
- (21 September 2007) The real science crisis: bleak prospects for young researchers. The Chronicle of Higher Education 54(4): A1. Find this article online
Man sues firm after claiming pill made him depressed
A HAWKHURST man is suing pharmaceutical giant Sanofi-Aventis after claiming that a diet pill made him depressed and suicidal.
Robert Johnson, 50, of Horns Road, said taking the appetite suppressant Acomplia for less than a month triggered psychiatric problems which led to him losing his £45,000-a-year job working for the Ministry of Defence in Sevenoaks.
The father-of-three moved to Hawkhurst in 2007 with his wife Judith when his job relocated.
Weighing more than 25 stone, he agreed to try the diet pill, also known as Rimonabant, in February 2008.
Mr Johnson, who had worked for the MOD for 22 years, said: "Two weeks later I broke down in tears at work in the middle of a chat with my boss about nothing in particular.
"This was completely out of the blue, so I went back to the doctor who put me on mild anti-depressants."
A few days later Mr Johnson had a breakdown and in April 2010 he was dismissed from his job. He had been in charge of nearly 60 people.
He said: "I felt I was worthless.
"I asked my wife to have me committed as I was worried I would hurt her and my daughters Hannah, Rebekah and Katherine.
"I felt suicidal. I dreamt of going to Beachy Head and getting close to the edge."
The Government demanded the drug be taken off the market two years ago.
Sanofi-Aventis declined to make a comment.
Virgo Health PR agency working to dispel Nurofen Plus sabotage rumour
The healthcare agency is handling crisis comms for Reckitt Benckiser around the revelations that thousands of packets of the over-the-counter painkiller may have been filled with an anti-psychotic drug called Seroquel.
The Daily Mail has this morning run with the front page headline ‘Painkillers "sabotaged"’, and this line has also been taken in The Daily Telegraph.
The Daily Mail writes today: ‘It is thought militant activists carried out the sabotage operation with the intention of damaging Nurofen Plus’s makers… The company may have been targeted because it tests some products on animals’.
A spokeswoman for Virgo Health, said the agency is ‘not happy’ with the Daily Mail’s line and denies the company uses animal testing.
The agency is issuing statements to the media from Nurofen Plus medical director Dr Aomesh Bhatt, the latest of which states: ‘Nurofen Plus has a firm policy of not testing on animals. We don’t know where the Daily Mail got their story’.
‘This speculation is not something that we are supporting at all,’ said the spokeswoman. ‘That’s an avenue we’re pursuing. It can’t be ruled out, but it’s not what we’re informed.’
She added that if the newspaper has information then it should be helping the company with its investigation.
The agency has been preparing for the issue over the ‘past few days’, and its messaging priority has been to advise people to check the packs in case they contain the wrong tablets.
‘We’re reiterating that it’s a serious issue, making sure consumers know what to do. As long as they’re vigilant, there is no issue. It’s quite simple because of the action that needs to be taken,’ said the Virgo Health spokeswoman.
Red Consultancy healthcare MD Pat Pearson commented that issues of this type are ‘among the most serious’ for the healthcare sector. He added: ‘Reckitt Benckiser and AstraZeneca (the manufacturer of Seroquel) have been quick to issue statements and ensure the media report the action they have under way’.
‘What they have also done well is to provide good guidance beyond the official statements, advising journalists that the problem is unlikely to be in manufacturing or supply by the companies.’
Insignia Communications founder Jonathan Hemus commented that the extensive use of Bhatt’s quotes in early press coverage ‘ensured that the brand had influence over how the story broke’.
However, he added: ‘Where I feel the brand could have done more is in providing additional information for consumers concerned that their tablets might have been affected.
‘When news broke early in the evening, BBC Online linked to Reckitt Benckiser’s site, but there was no sign of a statement on it, or on Nurofen’s own site (a short statement was added today) or its Facebook page.’
Virgo Health was appointed by Reckitt for the global Nurofen brief in 2006.
Unmask The Real Price Of Pills With Leslie's List - Forbes
You hand over the prescription to the pharmacist after waiting in line at the drop-off window. It’ll be ready in twenty minutes, he says. So you go and read a magazine, do a couple laps around the store, and then wander back. Finally your pills are ready. Here’s a question. Do you have any idea what the bill will be?
If you’re like me you don’t know if it’s going to be $5 or $175. If the former, there’s a sigh of relief. If the latter, hopefully insurance will step up. If insurance denies payment, you can always wait a few more days to see if the problem goes away on its own.
There are few transactions more byzantine than those at the pharmacy counter. And what makes it more frustrating is that pharmacists and doctors rarely help. When prescribing an eye drop or filling a statin prescription, they offer little information on what it will cost. If you ask they’ll say that it depends on your insurance. That’s true, but not helpful.
Leslie Ramirez, an internist working in Chicago, decided to build an simple and elegant Web solution. Ramirez has a practice with lots of uninsured and under-insured patients who would incur out-of-pocket prescription expenses. “It’s sad and it’s frustrating to hear patients say, ‘I didn’t get my blood pressure medicine because it was $100, even though you told me I was about to get a stroke’,” she says.
Two years ago Ramirez spent $20,000 of her own money to build the first version of a Web site that lists actual pharmacy prices. She got the data by calling around to pharmacies in Chicago and getting price quotes for common pills. The list grew to include 550 different drugs and she had to hire helpers to make the calls, though as the site grew in popularity, pharmacies began sending in their own updated price lists.
What she found surprised her. There was no rhyme or reason to any of the pricing. Take Glucophage, a common treatment for diabetes. In Chicago Walgreens charges 4 cents a pill if you buy 270 while CVS charges 38 cents a pill in groups of 60. What other industry has 9x variance?
Unmask The Real Price Of Pills With Leslie's List - Forbes
Arimidex, which women take after breast cancer surgery, can be had for $25 for 30 pills at Costco. The same 30 pills cost $340 at Walgreens.
Thursday, August 25, 2011
Chalk up another win for Ven-A-Care! Florida reaches $26M fraud settlement with Par Pharma - South Florida Business Journal
Florida was among five states that reached a $154 million settlement with Par Pharmaceuticals over allegations of Medicaid fraud.
Attorney General Pam Bondi said the state would collect $26.6 million from its portion of the settlement with the New Jersey-based company (NYSE: PRX). The state alleged that Par Pharma knowingly fixed drug prices in order to overbill the Medicaid program.
Another $9 million from the settlement will go to Ven-A-Care of the Florida Keys, which filed the whistleblower complaint that started this case. That company has collected over $100 million from filing whistleblower lawsuits against major drug companies.
Ven-A-Care co-owners Luis E. Cobo and Terry Mark Jones are also major investors in First State Bank of the Florida Keys. In fact, they recently asked regulators for permission to increase their stake in that bank.
Class 4 Drug Alert (Caution in use): Reckitt Benckiser (UK) Ltd - Nurofen Plus Tablets containing rogue Seroquel XL 50mg tablets - EL (11)A/21 : MHRA
Reckitt Benckiser (UK) Ltd has received three reports of rogue Seroquel XL 50mg tablets in cartons of three different batches of Nurofen Plus tablets. We understand cartons of Nurofen Plus tablets contained only rogue cut-down blisters of Seroquel XL tablets and no Nurofen Plus tablets were present. The rogue Seroquel XL tablet cut-down blisters included parallel imported tablets (from two different PLPI companies) and originator product.
The three batch numbers in the table above are the numbers on the Nurofen Plus tablet cartons which can be used to identify the at-risk stock.
Seroquel XL tablets are made by a different company (AstraZeneca) at a different site. Manufacturing errors by Reckitt Benckiser and AstraZeneca are not considered to be part of the cause at this stage.
We have some information to suggest possible links between these cases. It is possible that these problems are linked to product consolidation and/or erroneous examination of returns. Work is ongoing to obtain more information but the full facts may never be fully established.
Recipients are requested to remain vigilant about this issue and requested to report any further cases or additional concerns promptly to DMRC on 020 3080 6574.
There are marked visual differences between the two products but we have been informed that two patients took Seroquel XL instead of Nurofen Plus tablets.
For medical information enquiries related to Seroquel XL Tablets please contact AstraZeneca Ltd medical information department on 0800 783 0033. For medical information enquiries related to Nurofen Plus Tablets please contact Reckitt Benckiser (UK) Ltd medical information department on 0500 455 456.
Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this information to General Practitioners, Community Pharmacists and relevant clinics by copy of this letter.
Yours faithfully
Ian Holloway
MHRA DMRC Manager
Cancer Drug Shortages Getting Worse FDA Says - MSN Health - Cancer
WEDNESDAY, Aug. 24 (HealthDay News) -- Since 2010, the number of drugs either in short supply or not available at all has risen dramatically, according to the U.S. Food and Drug Administration.
Most of these are generic drugs given by injection and used in hospitals to treat serious conditions such as breast and testicular cancer. These shortages are putting patients at risk and compromising their care, experts say.
"FDA has been monitoring shortages for the last six years, and in 2010 we saw a large spike in shortages, which was a large jump from the year before," said Valerie Jensen, associate director of the Drug Shortage Program in FDA's Center for Drug Evaluation and Research. "That's what we are continuing to see in 2011. We are still seeing these large numbers of injectable drug shortages."
Dr. Richard Schilsky, past president of the American Society of Clinical Oncology, said "this is very serious, particularly the shortage of cancer drugs."
"Patients are being called everyday by their oncologist being told that they have to delay their treatment because the drug isn't available," Schilsky noted. "We have had to set priority lists of which patients are going to get treatment, because we don't always have an adequate drug supply. And it varies week-to-week; sometimes day-to-day."
There are several reasons for these ongoing shortages, Jensen said. Most are due to problems in manufacturing, ranging from contamination to late delivery of raw materials. Other problems include misprints in the drug's label or packaging and increased demand, she said.
Some people believe the FDA is causing part of the problem by not quickly inspecting plants to allow them to start producing the drug again, but Jensen challenged that notion.
"If the company is having a quality issue, the company doesn't have to wait for an FDA inspection to restart the manufacture," Jensen explained. The agency attempts to work with the companies to get drugs back into the market or tries to locate other sources for these drugs, she added.
However, Jensen noted that since most of these drugs are generic, companies don't make much money on them and may, in some cases, opt to discontinue them.
Joseph M. Hill, director of federal legislative affairs at the American Society of Health-System Pharmacists, said that, "from our members' perspective, it is kind of a crisis."
"We are seeing a shortage of critical drugs in the areas of cancer therapy, pain medications, including anesthetics, and some nutritional products. Some of these are products that people cannot do without," he said.
Another reason for the shortages, may be that companies are using them to increase prices, Dr. Otis Brawley, chief medical officer at the American Cancer Society, said.
"There is a pattern here. The drugs for which there is a shortage are the generic drugs, where the ability to make money is not as great," he said. "If the drug is off the market, they can reprice it."
While many of these delays are due to real manufacturing problems, "there are instances where I am certain that manufacture was stopped because they wanted to raise the price," Brawley said.
However, David Belian, a spokesman for the Generic Pharmaceutical Association, said that companies are not taking drugs off the market to raise prices.
"Shortages have been caused by everything from an insufficient supply of available raw materials to meet demand, to inadequate and delayed communications about shortages, both within the supply chain and also within and among the FDA's enforcement and drug shortages personnel," he said.
"FDA enforcement actions that delay or deter the production of certain products have also had an impact, as have changes in clinical practices that have altered volume production and use, as well as wholesaler stockpiling of critical medications," Belian said.
There are about a dozen commonly used cancer drugs that have been in and out of short supply for a year, Schilsky said. These include Doxil (doxorubicin), which is made exclusively by Janssen Products LP and used off-label to treat breast cancer.
"For some drugs there may be alternatives, but for some diseases there are not good substitutes," Schilsky said. "Some of these drugs are lifesaving drugs for patients. There is the potential that this could result in bad outcomes."
Another example of a drug that is in short supply is the leukemia drug cytarabine, where three makers of the drug are all experiencing delays.
"This is one of the bedrock treatments for acute leukemia and there is no suitable substitute for that," Schilsky said. "Patients with leukemia are patients who can't wait, they need treatment and they need it now."
Another chemotherapy drug, cisplatin, which is essential in the treatment of testicular cancer, is also in short supply. While the drug can be substituted in some disease, for testicular cancer it is the "curative therapy and the best possible therapy," Schilsky said. "Patients' lives are on the line here."
More information
For more information on drug shortages, visit the U.S. Food and Drug Administration.
Find More on MSN Health:
Drug Rep Arrested, Charged With Stealing Pills From Pharmacy -- KHBS NW Arkansas
Wyatt had taken approximately 900 oxycodone pills total -- 700, 30mg pills and 200 15mg pills.
Read more: http://www.4029tv.com/news/28802879/detail.html#ixzz1W0dBeOI7
Wednesday, August 24, 2011
Google to pay $500m over Canadian drug adverts - Telegraph
Google is to pay out $500m to avoid going to court over claims it made hundreds of millions of dollars out of adverts from Canadian pharmacies illegally selling prescription drugs such as Viagra to US consumers.
Spanish doctors told to prescribe cheaper generic drugs | World news | The Guardian
In a move designed to save €2.4bn (£2.1bn) a year, Spain's socialist government has passed a law forcing doctors and pharmacies to prescribe generic drugs rather than the more expensive brand names sold by pharmaceutical companies.
Spanish doctors will now have to complete prescriptions giving only the details of the active ingredients of the medicine that their patients must take, as well as the dose and format. The drugs are paid for partly by the state and partly by patients.
Pharmacies will be obliged to provide the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms.
The government believes the overall saving to the state and to the regional governments who administer health, combined with other drug-price reduction measures adopted on Tuesday, will be about €2.4bn (£2.09bn) a year.
"It means an important saving for the public accounts and will, without doubt, benefit most people who use public health services," said the Basque nationalist deputy Josu Erkoreka, whose party backed the move. "The interests of the big drugs companies must give way to public interest, and what matters is reducing the deficit and lowering the drugs bill for millionsof people who use public health services."
The prime minister, José Luis Rodríguez Zapatero, told parliament the measures would help Spain continue to lower the cost of drugs to the state, a move that began last year and which has led to the first-ever fall in the national pharmaceutical bill. This year's bill was already cut by 10%, in part because of measures that had increased the generic drugs used.
The change will help Spain's budget deficit as the government works to bring it down from the 11.1% of 2009 to 6% by the end of 2011.
But pharmaceutical firms will be hurt, claimed the Catalan nationalist deputy, Josep Antoni Duran i Lleida. Jobs are likely to be lost in the sector.
Zapatero is also considering reintroducing a wealth tax on the assets of Spain's rich, according to El País newspaper.
This tax was suppressed across the board in 2008, but with just 47,000 wealthy individuals reportedly accounting for €1bn of wealth-tax money, the government believes it has found an efficient way to raise extra tax.
In a surprise proposal, Zapatero on Tuesday also proposed a change to Spain's constitution, to limit the deficit by law. His proposal imitates one already made by the opposition People's party (PP), which immediately gave its backing.
Zapatero has called a general election for 20 November, but cross-party support means that if the two main parties can rapidly agree on a text the measure could be pushed through within a month.
Opinion polls suggest that with Spain's 21% unemployment, sluggish growth, and spending cuts, a government after the November elections will probably be led by the PP's Mariano Rajoy.
He criticised the government for failing to introduce the law earlier and for allowing public spending to soar after the economy crashed in 2008.
Rajoy also pledged to prolong a temporary tax cut on the purchase of newly built homes, introduced by the socialist government on Tuesday.
This tax cut, from 8% to 4%, aims to accelerate the sale of homes and reduce the stock of an estimated 700,000 newly built homes that remained on the market after the housing bubble burst three years ago. The cut will also benefit foreign buyers of holiday homes in Spanish resorts, where many of the unsold properties can be found.
Sanofi to Acquire Universal Medicare Unit; Terms Not Disclosed - Bloomberg
Sanofi’s Aventis Pharma Ltd. agreed to buy the branded nutraceuticals unit of India’s Universal Medicare Pvt. Ltd., Aventis said in a statement on its website today. Terms of the transaction weren’t announced.
Universal Medicare unit makes vitamins, antioxidants, mineral supplements and anti-arthritics, according to the statement.
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Florida Woman Charges Life-Threatening Blood Clot Caused by Yaz Birth Control Pill
NEW YORK, Aug. 23, 2011 /PRNewswire/ --
Wendy R. Fleishman of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP announced that Tiffany Littles, 33, of Jacksonville, Florida, filed a personal injury lawsuit against Bayer Healthcare Pharmaceuticals, Inc., for severe and lasting injuries caused by Bayer's birth control drug Yaz. Littles' complaint charges that Yaz is a dangerous prescription drug sold without adequate warnings about the risk of serious injuries.
(Logo: http://photos.prnewswire.com/prnh/20110823/SF56552LOGO)
In July 2008, Littles suffered a bilateral pulmonary emboli, cor pulmonale, and deep vein thrombosis ("DVT"), more commonly known as a blood clot. If left untreated, blood clots can break off and result in life-threatening conditions.
"I am bringing this lawsuit so that this traumatic event does not happen to anyone else," stated Littles. "I nearly died from taking this medication--the hospital even brought in a priest for me."
The complaint charges that Littles would not have been injured had Bayer properly warned patients of the dangers of using Yaz.
"The FDA's adverse event database for Yaz and Yasmin reveal a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clot formation, and sometimes death," commented attorney Fleishman. "Bayer failed to warn doctors and consumers, we allege, that Yaz and Yasmin pose a greater risk of serious injuries than earlier generation oral contraceptives."
The complaint was filed yesterday afternoon in the Philadelphia Court of Common Pleas.
For more information, please visit our Yaz birth control lawsuit page.
Tuesday, August 23, 2011
Nexium, Prilosec and Other Proton Pump Inhibitors Are Overprescribed, Should Carry Strongest Possible Warning, Public Citizen Tells FDA in Petition
AstraZeneca publishing payments to docs | Delaware Inc.
AstraZeneca has launched an online database to publish details about payments it makes to doctors in the U.S. The database will be updated quarterly, the drug giant said in a blog post.
The database includes payments to doctors for speaking and consulting fees. Drug companies hire doctors to inform members of healthcare communities about new drugs and also to perform research.
AstraZeneca’s supported transparency into doc payments in 2008, when Congress was debating creating a national registry of payments. “AstraZeneca believes that providing information to the public about our company, our products and how we do business is integral to improving patient health,” Tony Zook, then head of AstraZeneca’s U.S. business, said in 2008 of creating a national registry of payments.
A couple things have happened since forcing payments out into the open.
The federal health reform law passed in 2010 mandates that companies publicize payments to docs. Also, as a part of a settlement with the federal government last year, AstraZeneca agreed to make certain disclosures. AstraZeneca paid $520 million to settle claims with the U.S. Department of Justice that it illegally marketed its antispychotic drug Seroquel for uses not approved by federal regulators. The Justice Department said that AstraZeneca paid doctors to promote the drug for unapproved uses, and even footed the bill for doctors’ trips to resort locations, hoping that would boost prescriptions of the drug. Doctors may prescribe a drug as they see fit, but drug companies can only market drugs for uses approved by regulators.
AstraZeneca did not admit wrongdoing as a part of the settlement.
Ex-Duane Reade CEO Cuti Gets Three Years in Prison for Inflating Earnings - Bloomberg
“a gifted, arrogant, driven, entitled individual” who “bullied people into committing fraudulent acts to make the company look better than it actually was” to increase his pay.
AstraZeneca - Faslodex, NICE say no
Read more: http://www.foxbusiness.com/industries/2011/08/23/astrazenecas-faslodex-drug-not-good-use-resources-nice/#ixzz1VqaD5toJ
Monday, August 22, 2011
Holiday Reading: Prescribing by Numbers by Jeremy A Greene
The second half of the twentieth century witnessed the emergence of a new model of chronic disease—diagnosed on the basis of numerical deviations rather than symptoms and treated on a preventive basis before any overt signs of illness develop—that arose in concert with a set of safe, effective, and highly marketable prescription drugs. In Prescribing by Numbers, physician-historian Jeremy A. Greene examines the mechanisms by which drugs and chronic disease categories define one another within medical research, clinical practice, and pharmaceutical marketing, and he explores how this interaction has profoundly altered the experience, politics, ethics, and economy of health in late-twentieth-century America.Prescribing by Numbers highlights the complex historical role of pharmaceuticals in the transformation of disease categories. Greene narrates the expanding definition of the three principal cardiovascular risk factors—hypertension, diabetes, and high cholesterol—each intersecting with the career of a particular pharmaceutical agent. Drawing on documents from corporate archives and contemporary pharmaceutical marketing literature in concert with the clinical literature and the records of researchers, clinicians, and public health advocates, Greene produces a fascinating account of the expansion of the pharmaceutical treatment of chronic disease over the past fifty years.
While acknowledging the influence of pharmaceutical marketing on physicians, Greene avoids demonizing drug companies. Rather, his provocative and comprehensive analysis sheds light on the increasing presence of the subjectively healthy but highly medicated individual in the American medical landscape, suggesting how historical analysis can help to address the problems inherent in the program of pharmaceutical prevention.
http://www.amazon.co.uk/Prescribing-Numbers-Drugs-Definition-Disease/dp/0801884772