Sunday, May 31, 2009
Saturday, May 30, 2009
Pharma Payola - West Virginia style
Disgustingly, West Virginia doctors took 15,382 goodies worth millions during 2008 from pharmaceutical manufacturers trying to induce the physicians to prescribe their high-priced brands.
Since the state has only 5,152 licensed doctors and nurse-practitioners, and since some physicians refuse such gifts, it's obvious that many other doctors raked in multiple "inducements."
But West Virginia patients can't learn whether their physicians are among the payola-takers, because the state's Pharmaceutical Cost Management Council voted to hide the names of doctors getting more than $10,000 a year each. Thank heaven, the worthless council is being abolished, and its duties may be switched to a new agency to be created in the current special legislative session.
The first -- and last -- full-year disclosure report by the council was released Thursday. It listed five anonymous doctor payments over $100,000 each, including one above $125,000 to an unnamed physician who makes international talks promoting a prescription brand. The report also included 42 anonymous payments above $20,000 and 574 above $2,500. The great majority, 14,808 nameless payments, were below $2,500. However, it's clear that some doctors got several of these handouts.
MoreFriday, May 29, 2009
Sanofi Aventis pays thru the nose
Sanofi-Aventis will pay $95.5 million to settle allegations that it overcharged state Medicaid programs for anti-inflammatory nasal sprays, the Justice Department announced Thursday.
The settlement resolves charges that between 1995 and 2000 Aventis Pharmaceutical Inc. knowingly misreported its best drug prices to Medicaid programs. Under U.S. law, drug makers are required to report to the government the best prices for their drugs and give those rates to Medicaid.
The Justice Department said Aventis manipulated its "best price" numbers for the nasal sprays by entering into an agreement with the HMO Kaiser Permanente that repackaged Aventis' drugs under a new label.
More at WSJThursday, May 28, 2009
Risky business at the FDA
US regulators have issued guidelines to drugmakers about the way they should present risk information for the treatments when advertising on television or in journals.
The 27-page “Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion”
http://www.fda.gov/cder/guidance/7427dft.pdf has been issued by the US Food and Drug Administration. It covers a wide range of areas and includes advice that television advertisements should avoid using “distracting images and music that can reduce viewers' comprehension of potential side effects”.
Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the agency says. The guidelines note that busy and frequent scene changes plus camera angles "can misleadingly minimise the risks of the product being promoted by detracting from the audience's comprehension”.
The FDA noted that "if risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression". In terms of the advice over print, the agency also spoke about consistent use of white space, font style and size.
The guidance is in part a response to criticism of the industry for using various techniques on television and in print which could be seen as downplaying risks while emphasising the benefits of the drug. The agency concludes that it will consider "the net impression conveyed by all the elements of a piece”. For this reason, “manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole".
The FDA guidelines are not mandatory but Ken Johnson, senior vice-president for the Pharmaceutical Research and Manufacturers of America, noted that the industry has already adopted voluntary guidelines that say risks "should be presented in clear, understandable language without distraction". He added that drugmakers "remain committed to producing responsible, balanced promotional materials".
By Kevin Grogan
PharmaTimes
The 27-page “Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion”
http://www.fda.gov/cder/guidance/7427dft.pdf has been issued by the US Food and Drug Administration. It covers a wide range of areas and includes advice that television advertisements should avoid using “distracting images and music that can reduce viewers' comprehension of potential side effects”.
Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the agency says. The guidelines note that busy and frequent scene changes plus camera angles "can misleadingly minimise the risks of the product being promoted by detracting from the audience's comprehension”.
The FDA noted that "if risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression". In terms of the advice over print, the agency also spoke about consistent use of white space, font style and size.
The guidance is in part a response to criticism of the industry for using various techniques on television and in print which could be seen as downplaying risks while emphasising the benefits of the drug. The agency concludes that it will consider "the net impression conveyed by all the elements of a piece”. For this reason, “manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole".
The FDA guidelines are not mandatory but Ken Johnson, senior vice-president for the Pharmaceutical Research and Manufacturers of America, noted that the industry has already adopted voluntary guidelines that say risks "should be presented in clear, understandable language without distraction". He added that drugmakers "remain committed to producing responsible, balanced promotional materials".
By Kevin Grogan
PharmaTimes
NICE advice
The UK's National Institute of Health and Clinical Excellence has published new guidance for the month of May.
There are three clinical guidelines that may impact on primary care covering coeliac disease, low back pain and type 2 diabetes (update).
The coeliac disease guideline (QRG) covers the recognition and assessment of coeliac disease and the care of children and adults who are undergoing the diagnostic process for coeliac disease.
The low back pain guideline (QRG) specifically addresses the care and treatment that people who have persistent non-specific low back pain.
The type 2 diabetes guideline (QRG) provides an update to previous guidelines by clarifying the place in therapy for gliptins (sitagliptin and vildagliptin), glitazones (pioglitazone and rosiglitazone) and exenatide. These treatments are recommended in cases where there is intolerance to established agents (metformin or sulphonylureas) or in combination with the established agents when initiation of insulin is unacceptable for employment, social or other reasons.
http://www.prescriber.org.uk/The liver is evil, it must be punished!
A Food and Drug Administration report released yesterday recommends stronger warnings and dose limits on drugs containing the painkiller acetaminophen (paracetamol), citing an increased risk of liver injury.
MoreWednesday, May 27, 2009
Cardinal sinners?
NEW YORK (Reuters) - Three former senior officers of Cardinal Health Inc
The regulator had accused former Chief Financial Officer Richard Miller, former controller and principal accounting officer Gary Jensen and former senior vice president of finance in the pharmaceutical products division, Michael Beaulieu, of securities fraud.
More
The medical riddle
Abraham Verghese asks the question.
A man walks into a bar, offers to keep his head completely submerged in a bucket of water for twenty minutes and if he doesnt he will buy drinks all around and if he does the patrons must stand him a round of drinks. He does and so they do. The question is how did he do it?
YouTube has the answer!
A man walks into a bar, offers to keep his head completely submerged in a bucket of water for twenty minutes and if he doesnt he will buy drinks all around and if he does the patrons must stand him a round of drinks. He does and so they do. The question is how did he do it?
YouTube has the answer!
FDA - the new brooms
The FDA as a Public Health Agency
Since that time, the bureau has grown into the Food and Drug Administration (FDA), an agency in the Department of Health and Human Services (DHHS) responsible for oversight of more than $2 trillion in medical products, food, and other consumer goods. What has remained constant is the agency's "overriding purpose," in the words of the Supreme Court, of protecting the public health.1 As the new commissioner and principal deputy commissioner of the FDA chosen by President Barack Obama, we would like to provide a broad overview of how we intend to embrace this role.
The Institute of Medicine has defined the mission of public health as "fulfilling society's interest in assuring the conditions in which people can be healthy." To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA's job is to support this access and, in doing so, to promote health, prevent illness, and prolong life. The ultimate measures of the FDA's success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.
The urgent need to develop and produce a vaccine against H1N1 influenza virus provides an illustration of the agency's public health role. Laboratory scientists at the FDA are growing the virus and will make reagents for vaccine-potency testing, reviewers will help to design and oversee the clinical trials, and inspectors will oversee the quality of the production process. The agency's success will be determined by the nation's access to a safe and effective vaccine.
The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented — a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency's usual routines. We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.
In the domain of medical products, it has been said that the FDA has just two speeds of approval — too fast and too slow. Critics concerned about haste point out, accurately, that drugs and other products are generally approved on the basis of relatively small studies and that safety problems often emerge when large populations are exposed to the products. Those worried about delay note, correctly, that people with life-threatening diseases have no time to wait. A public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. Some benefits are not worth the risk; some risks are worth taking. Key considerations are the severity of the illness at issue, the availability of alternative treatments or preventive interventions, and the current state of knowledge about individual responses.
The FDA must make difficult decisions in the absence of ideal information. For medical products, the FDA Amendments Act of 2007 strengthened the agency's ability to place restrictions on the use of medications at the time of approval while requiring that additional safety data be gathered. These tools allow the FDA opportunities to change the regulatory oversight of products as they move from limited use in clinical trials to adoption in the medical system. The ability to detect and act on safety signals quickly can give an additional layer of confidence to support earlier approval of important medications.
Fortunately, not every FDA action is a challenging regulatory decision that requires balancing risk against benefit. Collaboration with sister public health agencies in DHHS, industry, consumer and patient organizations, and the public will lead to exciting opportunities for progress in public health.
We intend to work closely with the Centers for Disease Control and Prevention (CDC) to identify priority areas for joint action — such as the response to infectious-disease emergencies and outbreaks of foodborne illnesses and the development of safety systems to prevent lethal overdoses and drug interactions.
We look forward to working with the National Institutes of Health, the pharmaceutical and biotechnology industries, academic medical centers, and research universities to accelerate the development of cures. As scientists identify fruitful pathways for research on treatments for debilitating diseases, FDA regulators should discuss with them the level of evidence necessary for the initiation of human trials and the eventual approval of treatments.
To make important new treatments available to patients, the FDA should collaborate with the Centers for Medicare and Medicaid Services — one of the largest health care payers in the United States — as well as with industry and patient and consumer groups to explore ways of shortening the time from approval to reimbursement. One emerging opportunity is the area of personalized medicine, in which the agency should work with scientific leaders on novel approaches to treating illness.
In the domain of food safety, a public health approach starts with the use of data to identify the riskiest parts of an enormous and complex system. The FDA should partner with the Department of Agriculture and other federal agencies, states, and other authorities to establish a modern food-safety system focused on prevention of contamination. Working with Congress to modernize food-safety laws, the FDA must strive to build safeguards into every step of the production and distribution process.
From our vantage point, the recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility.
The CDC and the FDA should also work closely to identify areas of potential progress in nutrition. A laissez-faire approach to nutritional claims can lead to more confusion than understanding. Working with industry and others, the FDA can support efforts to educate the public about nutrition and promote more healthful foods.
Globalization intensifies all the challenges the agency faces. With more than 200,000 companies from around the world selling food, cosmetics, or medical products in the United States, a public health framework provides the only viable way of protecting the American public. To anticipate the next import crisis like that involving contaminated heparin, the agency should assess imported products for their potential to cause significant problems.
The FDA should facilitate the development of safety standards where none exist and then, working with our international partners, build a system with multiple levels of oversight. Safety must be the shared responsibility of not only the producer but also the country of origin, the importer, the importing country, and the final company in the supply chain. Some elements of this system, such as international outreach and coordination, can be implemented quickly; others will take years to develop. Along the way, new challenges are likely to arise. As they do, the FDA must respond forcefully and provide timely and credible information to the public.
Indeed, one of the greatest challenges facing any public health agency is that of risk communication. We all accept small risks in our daily lives, from the risk of falling in the shower and sustaining a head injury to the risk of having a car accident on the way to the grocery store. One reason we are rarely fearful of these risks is our perception that we have control over them. When it comes to food and drugs, even small risks can cause considerable fear and anxiety, especially when they seem to be out of our control. Yet all pharmaceuticals have some potential adverse effects, and many raw foods may harbor natural pathogens.
The FDA's job is to minimize risks through education, regulation, and enforcement. To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits — and about what organizations and individuals can do to minimize risk. When, like the FDA, Americans must make choices about medication, devices, foods, or nutrition in the absence of perfect information, the FDA cannot delay in providing reasonable guidance — guidance that informs rather than causes unnecessary anxiety.
For these communications to have credibility, the public must trust the agency to base its decisions on science. We recognize the importance of a management approach that respects the expertise and dedication of the FDA's career scientists. In recent years, the agency has struggled to handle controversies involving the safety of regulated products, opening the door to legitimate questions from the media, the public, and Congress about whether the public interest is being served. Establishing the FDA as a public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making. It also requires that the agency define and protect integrity in its basic processes.
Transparency is a potent element of a successful strategy to enhance the work of the FDA and its credibility with the public. Whenever possible, the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making process to the public.
We are honored to be chosen by President Obama and inspired by his commitment to the FDA and his proposed historic increase to its budget. More than a century ago, his predecessor President Roosevelt could not have foreseen the introduction of modern antibiotics, chemotherapy, and genomic medicine or the potential regulation of tobacco products — let alone the challenges of the 21st century. The FDA has always been a work in progress. Updating this work means modernizing scientific and legal regulatory approaches to a host of complex matters. Succeeding will require respecting the tradition of the FDA and its mission of public health.
No potential conflict of interest relevant to this article was reported.
Source Information
Dr. Hamburg is the commissioner, and Dr. Sharfstein the principal deputy commissioner, of the Food and Drug Administration, Silver Spring, MD.
This article (10.1056/NEJMp0903764) was published at NEJM.org on May 26, 2009. It will appear in the June 11 issue of the Journal.
References
United States v. Bacto-Unidisk, 394 U.S. 784 (1969). (Accessed May 18, 2009, at http://supreme.justia.com/us/394/784/case.html.)
Source
Tuesday, May 26, 2009
AstraZeneca - Seroquel: summary judgement
A Delaware judge has ruled in favor of drugmaker AstraZeneca in a lawsuit claiming that the company's anti-psychotic drug Seroquel causes diabetes.
In a one-paragraph ruling issued Tuesday, Judge Joseph Slights III in Wilmington granted the company's request to exclude testimony from a medical expert for a Kansas woman who claimed that Seroquel caused her to develop diabetes.
Slights said that in the absence of competent expert testimony, he determined that the court must grant summary judgment to London-based AstraZeneca in the case.
The case had been scheduled to go to trial in late June.
SourceMore here.
Pharma Giles writes ...
Phoni Pharmaceuticals today announced that it was intending to appoint the world-famous blogger, Gordon “Bonkers” Brown, to be its new global Consumer Product Director for Perplexedia, Phoni’s over-the counter treatment for male pattern baldness.
“Gordon’s been covering up the bald spots in the UK economy for years,” said Phoni’s Director of Global Marketing, Rich Pillager, “and he only got caught out when the financial meltdown hurricane blew away his hairpiece.”
“Bonkers” Brown has become famous for his hysterically funny YouTube performances as the bumbling and inept “Prime Minister” of “The United Kingdom”, as typified above.
“Basically, the guy is an arrogant, incompetent, bare-faced liar with a track record of complete disaster, and yet he’s managed to get away with holding down senior government positions for over 12 years,” said Pillager. “His entire operation has been shown to be as inept as it is totally corrupt, concentrating solely on financial reward for himself and his friends at the expense of everything else…”
“Obviously, he’s just the man we need to direct sales of one of our leading consumer healthcare brands. We fully anticipate that he’ll be free to join our company in a few months time…”
In the real world, it seems that some pharmaceutical companies think that employee blogging is a bad thing…
Activis help define gouging!
The Healthcare Channel learned of a specific example of pharmaceutical price inflation that serves as a good case for discussing the merits of various healthcare reform measures being considered by Congress.
The generic drug maker Actavis recently raised the price of a generic drug, Acetesol HC (hydrocortisone/acetic acid ear drops), by more than 1000%. The old price was approximately $20 USD. The new price is more than $200 USD.
We asked the company to explain this dramatic change in price. Actavis U.S. declined our invitation to appear on The HCC. According to a company spokesperson, the reason the price of acetesol was raised more than 1000% was because Actavis is now the sole manufacturer of the drug. Other generic drug manufacturers stopped making it for reasons unrelated to Actavis. Actavis now has monopoly pricing power and raised the price to match what the drug was selling for as a branded patented drug, even though the drug is off patent and still generic.
MoreMonday, May 25, 2009
H1N1 contd.
If you receive an email from the Department of Health telling you not to eat tinned pork because of swine flu - ignore it. It's Spam.
Daiichi show Ranbaxy who's the daddy!
Almost a year after sealing a deal to sell his family's 34.8% stake in Ranbaxy Laboratories, India's leading generics drugs maker, to Japanese pharma giant Daiichi Sankyo for a cool $2 billion, billionaire Malvinder Singh stepped down from his post of chairman, CEO and managing director.
Two directors nominated by Singh to Ranbaxy's 10-member board, also resigned, marking the end of the Singh family's 48-year hold over the company. Ranbaxy was founded by Malvinder Singh's grandfather Bhai Mohan Singh in 1961.
More
Two directors nominated by Singh to Ranbaxy's 10-member board, also resigned, marking the end of the Singh family's 48-year hold over the company. Ranbaxy was founded by Malvinder Singh's grandfather Bhai Mohan Singh in 1961.
More
Sunday, May 24, 2009
AstraZeneca - Seroquel: Invesigator Initiated Trials
A recently unsealed court document shows how AstraZeneca refined its marketing strategy concerning the use of investigator-initiated trials (IITs) for its antipsychotic Seroquel by interviewing employees with previous experience with competitors’ IIT programs. The document — an internal email sent in August 2003 by an AstraZeneca employee to the Seroquel Global Brand Team — details the results of company research into how Eli Lilly, Pfizer, Bristol-Myers Squibb and Johnson & Johnson subsidiary Janssen used IIT programs.
Hat tip: Robyn C
Friday, May 22, 2009
Confessions of a Vioxx Saleswoman
This is her Survivor blurb:
Corinne Kaplan takes great pride in being able to manipulate the people around her. As a pharmaceutical sales rep, this smart and sexy, self-described bitch, is in it purely for the money. At work, Corinne must convince physicians to prescribe her products. Now, Corinne is looking to convince her fellow tribe mates that she's trustworthy, while ready to sell them out behind their backs.
This catty former sorority girl uses her wit and sex appeal to further her goals.
This catty former sorority girl uses her wit and sex appeal to further her goals.
Here's what she said about selling Vioxx:
At one point, Corinne insisted, “I have no moral compass.” The most damning illustration has to do with her (now former) job as a pharmaceutical sales rep, where she said she knowingly sold drugs to physicicans that she knew would kill people. “Selling drugs is a lie. I sold drugs that I knew damn well—I sold Vioxx for Merck before it got taken off the market for killing people. I knew damn well it was dangerous; I went around telling them to write it. There’s a lot of serious lying I’ve done in my life,” she said.
J&J buy Cougar for abiraterone
Johnson & Johnson has signed an agreement to acquire Cougar Biotechnology for just under $1 billion, a deal which will give it access to the much-touted investigational prostate cancer drug abiraterone.
MIchael Moore's Meltdown Movie
Michael Moore's documentary about the economic crisis will hit theaters on Oct. 2.
The announcement was made Thursday by Overture Films and Paramount Vantage.
The film is not yet titled. Moore earlier planned to make it more broadly about America as an empire. Instead, the documentary explores the causes of the global economic meltdown. Moore has called it "the biggest swindle in American history."
Huff Po
The announcement was made Thursday by Overture Films and Paramount Vantage.
The film is not yet titled. Moore earlier planned to make it more broadly about America as an empire. Instead, the documentary explores the causes of the global economic meltdown. Moore has called it "the biggest swindle in American history."
Huff Po
GSK's $1.9 billion tax bill
UK drug company GlaxoSmithKline is battling the U.S. Internal Revenue Service over a potential $1.9 billion in back taxes, interest and penalties, according to The Wall Street Journal.
The IRS is investigating a tax-savings technique at Glaxo known as "earnings stripping," the WSJ reported. The practice, which involves claiming interest deductions for payments to units abroad that in fact never leave the parent company, is popular among foreign companies with large U.S. operations, the newspaper said.
Reuters
The IRS is investigating a tax-savings technique at Glaxo known as "earnings stripping," the WSJ reported. The practice, which involves claiming interest deductions for payments to units abroad that in fact never leave the parent company, is popular among foreign companies with large U.S. operations, the newspaper said.
Reuters
Thursday, May 21, 2009
Pharma Giles writes ...
A D V E R T I S E M E N T :
Calling Nurses Everywhere:
Tired of working long hours for low pay and no recognition?
Then why not earn some money on the side by working part time for the World’s largest imaginary pharmaceutical company?
Phoni Pharmaceuticals is offering a unique opportunity to nursing staff everywhere to help patients suffering from chronic pain. Viletoxx is a unique treatment for arthritic and neurological pain that offers its patients a significant prospect of relief from suffering – for ever!
The Australian Journal of Boneheads and Joints Medicine, the premier scientific medical journal in its field, has called Viletoxx:
“a miracle drug”
“the most efficacious treatment of its type available”
“an indispensable treatment in the fight against pain”
“life-enhancing”
So why not play a part in bringing this unique therapy to the patients in your care – AND get paid for it?
All we ask is that you compromise those silly and outdated principles of medical patient confidentiality, and tell us the names of any of your patients that are being prescribed pain-killers other than Viletoxx, and the name of the pharmacist or the doctor involved.
Our team of expert Pharmaceutical Sales Representatives will do the rest.
It’s easy money – and don’t you deserve it? And the chances are, by doing so you’ll be helping to usher the people under your care into a new world that’s free of the agony of chronic pain.
So why not contact Phoni today?
Your patients won’t live to regret it….
A story from the parallel universe of reality can be found here…
Over 55 - then you are a patient!
The British Medical Journal has published the results of a meta-analysis into the efficacy of different classes of blood pressure lowering drugs in preventing coronary heart disease (CHD) and stroke. Additionally, this study aimed to determine who should be treated.
The analysis included data from 147 randomised controlled trials and 464,000 individual participants. The data were analysed by categorising patient data into one of three groups: no history of vascular disease, a history of CHD, or a history of stroke.
It was found that a blood pressure reduction of 10mmHg for systolic blood pressure and 5mmHg for diastolic blood pressure resulted in a 22% reduction in CHD events (95% confidence interval: 17% - 27%) and a 41% reduction in stroke (33% - 48%). The five main classes of drugs (thiazides, beta-blockers, ACE inhibitors, angiotensin receptor blockers and calcium channel blockers) were all equally effective in reducing CHD events while calcium channel blockers were slightly more effective in reducing strokes. Reductions in CHD and stroke appear to persist with reductions as low as blood pressures of 110/70mmHg; below this level there are insufficient data to draw conclusions.
The authors conclude that, “consideration should be given to replacing current policies that focus on routinely measuring blood pressure with policies that focus on routinely lowering blood pressure“. This assertion has been reported in the general media (BBC).
Hat tip: http://www.prescriber.org.uk/
Wednesday, May 20, 2009
Elsevier Pharma Solutions
Posted without comment.
Elsevier Pharma Solutions
View more presentations from Varshaa Ashish.
Hamburg confirmed as Commish
On May 18th, the full US Senate unanimously confirmed Dr Margaret Hamburg as the next commissioner of the FDA.
She awaits swearing in.
AstraZeneca - Seroquel: "grease the skids for dementia"
AstraZeneca set a strategy of marketing its Seroquel antipsychotic drug for unapproved, or “off-label,” uses as early as 2000, according to documents unsealed as part of litigation over the medicine.
“Key Success Factors: Broaden Seroquel use on and off label,” AstraZeneca officials wrote in a December 2000 “Seroquel Strategy Summary” provided by a spokeswoman for the plaintiffs’ lawyers in the cases. Under required actions by the company, the plan called for sales managers to “utilise whole selling team. Educational programmes to share off label data,” according to the documents.
The plan is among thousands of pages of files lawyers suing AstraZeneca over Seroquel are set to release on a Web site today, according to Kerri Axelrod, a spokeswoman for the plaintiffs’ lawyers, who released some of the documents yesterday, along with a chart describing dozens more.
“These documents do not advocate the inappropriate promotion of Seroquel,” Tony Jewell, AstraZeneca’s spokesman, said in an e-mailed statement. He noted the company’s researchers have “invested significant resources” seeking to find new ways to have the drug help mentally-ill patients.
More than 15,000 patients have sued AstraZeneca, claiming the company withheld information of a connection between diabetes and Seroquel use from doctors and users of the drug.
The Lawsuits
Seroquel, which generated sales of $4.45 billion last year, is the company’s second-biggest seller after the ulcer treatment Nexium.
The U.S. Food and Drug Administration first approved Seroquel in 1997 for use in treating symptoms of psychotic disorders and then granted AstraZeneca the right in 2001 to market it as a schizophrenia treatment. Its usage was expanded twice more during a two-year period starting in 2004 to treat bipolar disorders.
Many of the lawsuits contend AstraZeneca promoted the drug for unapproved uses. Some of the suits have been consolidated before a federal judge in Florida. The company has denied any wrongdoing.
The documents are being made public after London-based AstraZeneca agreed earlier this month to drop their confidential status in a deal with lawyers representing former Seroquel users, Jewell said.
Advocacy Group
A chart of the documents that were unsealed was made available by the Association for American Justice, an advocacy group representing plaintiffs’ lawyers. Axelrod, a spokeswoman for the group, said lawyers representing ex-Seroquel patients asked her organization to handle the public release of the documents.
The chart notes that AstraZeneca has unsealed documents that include marketing advice from the drug’s brand manager in 2002. The manager advised in handwritten notes to “grease the skids for dementia” and market the antipsychotic Seroquel for the elderly, according to the documents.
“Turn on the DTC machine,” referring to direct to consumer marketing, Consumer Brand Director Denise Campbell said in the 2002 notes, according to an e-mail exchange produced for lawsuits over the drug, Axelrod said. The drug hasn’t been approved for dementia treatment.
Under U.S. law, doctors may prescribe drugs approved by the FDA for any ailment they believe the medicine can treat. Drugmakers may only promote their products for approved illnesses and not for so-called “off-label” uses.
‘Available to Them’
Off-label prescriptions are common because “doctors make use of the medicines they have available to them in order to provide treatment they believe is best for their patients,” Jewell said in a statement.
“The company has sought to generate long-term revenue growth by pursuing the investigation of new indications, formulations and comparative data to provide important clinical information to prescribers,” he added.
A 2001 public-relations plan for Seroquel said the company should focus on achieving “aggressive market penetration” among adolescents, the elderly and patients with bipolar disorder to protect the drug’s market share against rival antipsychotics such as Eli Lilly & Co.’s Zyprexa or Johnson & Johnson’s Risperdal.
AstraZeneca’s effort to market Seroquel for unapproved uses continued in 2003 when it prepared a paper to highlight the drug’s performance in clinical tests on bipolar patients, according to the documents.
Paper’s Objectives
One of the paper’s objectives was to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” officials noted in the unsealed documents.
AstraZeneca executives also indicated in the papers that they were aware that issues involving off-label marketing and information were sensitive.
Officials of AstraZeneca’s U.S. unit, based in Wilmington, Delaware, noted in a May 2004 e-mail that slides prepared in connection with a study involving off-label use of Seroquel were “financed outside of commercial for obvious legal reasons.”
More at Bloomberg
“Key Success Factors: Broaden Seroquel use on and off label,” AstraZeneca officials wrote in a December 2000 “Seroquel Strategy Summary” provided by a spokeswoman for the plaintiffs’ lawyers in the cases. Under required actions by the company, the plan called for sales managers to “utilise whole selling team. Educational programmes to share off label data,” according to the documents.
The plan is among thousands of pages of files lawyers suing AstraZeneca over Seroquel are set to release on a Web site today, according to Kerri Axelrod, a spokeswoman for the plaintiffs’ lawyers, who released some of the documents yesterday, along with a chart describing dozens more.
“These documents do not advocate the inappropriate promotion of Seroquel,” Tony Jewell, AstraZeneca’s spokesman, said in an e-mailed statement. He noted the company’s researchers have “invested significant resources” seeking to find new ways to have the drug help mentally-ill patients.
More than 15,000 patients have sued AstraZeneca, claiming the company withheld information of a connection between diabetes and Seroquel use from doctors and users of the drug.
The Lawsuits
Seroquel, which generated sales of $4.45 billion last year, is the company’s second-biggest seller after the ulcer treatment Nexium.
The U.S. Food and Drug Administration first approved Seroquel in 1997 for use in treating symptoms of psychotic disorders and then granted AstraZeneca the right in 2001 to market it as a schizophrenia treatment. Its usage was expanded twice more during a two-year period starting in 2004 to treat bipolar disorders.
Many of the lawsuits contend AstraZeneca promoted the drug for unapproved uses. Some of the suits have been consolidated before a federal judge in Florida. The company has denied any wrongdoing.
The documents are being made public after London-based AstraZeneca agreed earlier this month to drop their confidential status in a deal with lawyers representing former Seroquel users, Jewell said.
Advocacy Group
A chart of the documents that were unsealed was made available by the Association for American Justice, an advocacy group representing plaintiffs’ lawyers. Axelrod, a spokeswoman for the group, said lawyers representing ex-Seroquel patients asked her organization to handle the public release of the documents.
The chart notes that AstraZeneca has unsealed documents that include marketing advice from the drug’s brand manager in 2002. The manager advised in handwritten notes to “grease the skids for dementia” and market the antipsychotic Seroquel for the elderly, according to the documents.
“Turn on the DTC machine,” referring to direct to consumer marketing, Consumer Brand Director Denise Campbell said in the 2002 notes, according to an e-mail exchange produced for lawsuits over the drug, Axelrod said. The drug hasn’t been approved for dementia treatment.
Under U.S. law, doctors may prescribe drugs approved by the FDA for any ailment they believe the medicine can treat. Drugmakers may only promote their products for approved illnesses and not for so-called “off-label” uses.
‘Available to Them’
Off-label prescriptions are common because “doctors make use of the medicines they have available to them in order to provide treatment they believe is best for their patients,” Jewell said in a statement.
“The company has sought to generate long-term revenue growth by pursuing the investigation of new indications, formulations and comparative data to provide important clinical information to prescribers,” he added.
A 2001 public-relations plan for Seroquel said the company should focus on achieving “aggressive market penetration” among adolescents, the elderly and patients with bipolar disorder to protect the drug’s market share against rival antipsychotics such as Eli Lilly & Co.’s Zyprexa or Johnson & Johnson’s Risperdal.
AstraZeneca’s effort to market Seroquel for unapproved uses continued in 2003 when it prepared a paper to highlight the drug’s performance in clinical tests on bipolar patients, according to the documents.
Paper’s Objectives
One of the paper’s objectives was to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” officials noted in the unsealed documents.
AstraZeneca executives also indicated in the papers that they were aware that issues involving off-label marketing and information were sensitive.
Officials of AstraZeneca’s U.S. unit, based in Wilmington, Delaware, noted in a May 2004 e-mail that slides prepared in connection with a study involving off-label use of Seroquel were “financed outside of commercial for obvious legal reasons.”
More at Bloomberg
Novartis buy Ebewe
Novartis said it was buying the injectable generic cancer drugs business of Austrian Ebewe Pharma for €925m ($1.3bn) in cash to boost its copycat medicine unit Sandoz.
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Tuesday, May 19, 2009
Merck - Vioxx: Nurse Clouseau is on your trail
"Bone Care Nurse"!
Too easy!!!!!
AUSTRALIAN marketing staff from pharmaceutical giant Merck & Co paid specialist nurses half-a-million dollars to "hunt" through patient records for potential candidates for their blockbuster anti-arthritis drug Vioxx.
The Federal Court was told the company aimed to identify 100 patients of each targeted general practitioner who were not taking Vioxx and could be recommended to take up the drug for their condition.
Known as the "bone and joint care program", the marketing initiative employed "bone care" nurses -- via an independent third party -- to go through patients' records with permission of their general practitioner.
A class action heard yesterday that nurses interviewed these patients, some of whom were over 60 and had osteoarthritis, about their condition and options for pain management.
The plaintiff also said yesterday in the court in Melbourne that Merck gave pharmacists incentives to recommend Vioxx to patients who were on other drugs such as paracetamol.
Merck, Sharp and Dohme and its parent company Merck & Co are being sued by more than 1000 Australians, led by Graeme Peterson, who alleges the drug caused his heart attack in December 2003.
Wyeth - Protonix: whistleblower alert!
WASHINGTON - The Justice Department yesterday accused Wyeth, one of the nation's biggest drugmakers, of cheating Medicaid programs out of hundreds of millions of dollars by overcharging for the stomach-acid drug Protonix.
The Justice Department and more than a dozen states - including Delaware - have joined in two whistle-blower lawsuits against the Madison, N.J.-based drug company filed in federal court in Massachusetts.
Monday, May 18, 2009
Alliance Boots - wholesale cuts
Alliance Boots Britain's biggest pharmacy chain, posted an 11.6 percent rise in full-year profit and said it had performed well in its new financial year, defying a recession that has hit many of its retail rivals.
But the group, which employs over 110,000 people worldwide, said on Monday a restructuring of its pharmaceutical wholesale division would result in about 1,500 job losses.
GSK pact with Oxford BioTherapeutics
GlaxoSmithKline (GSK.L) took another step to bolster its early-stage pipeline of cancer drugs on Monday by signing a deal worth up to $370 million with privately held British biotech group Oxford BioTherapeutics.
The strategic alliance covers the discovery and development of new therapeutic antibodies for treating primary, metastatic and recurring forms of cancer, with Glaxo developing drugs against selected targets identified by Oxford BioTherapeutics (OBT).
OBT will also develop one antibody through to clinical proof of concept, at which point Glaxo will have an option to license it.
OBT said it would receive an undisclosed upfront payment and would be eligible for up to a total of $370 million in milestone payments, depending on the success of the new drugs in development. It will also get royalties on any eventual sales.
Pharma Giles writes......
A furore has erupted following The Scientist magazine’s revelations that Phoni Pharmaceuticals paid an undisclosed sum to scientific vanity publisher Elsleazier to produce several volumes of a publication that had the look of a peer-reviewed medical journal but which contained only reprinted or summarized articles, most of which presented data favourable to Phoni products. The journal appeared to act solely as a marketing tool with no disclosure of company sponsorship.
The Australian Journal of Boneheads and Joint Medicine, which was published by Extracta Moneya, a division of Dutch scientific publishing juggernaut Greed-Elsleazier, also contained little in the way of advertisements apart from ads for Formonimax, a Phoni drug for osteoporosis, and Viletoxx, Phoni’s controversial pain-killer.
In a statement provided last week to The Scientist, an eminent Australian physician and long-time member of the World Association of Medical Editors reviewed four issues of the journal that were published from 2003-2004.
“An average reader, such as a doctor, could easily mistake the publication for a genuine peer reviewed medical journal”, he said. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for Phoni."
“They’ve done a heck of good job, and it was only when I noticed that some of the names of the so-called “honorary editorial board” appeared to be made up that I became suspicious,” the reviewer admitted.
“Professor Phil.
A spokesperson for Elsleazier, however, told The Scientist, "All of our journals are thoroughly peer-reviewed prior to publication, by our accountants. Our company would never publish a journal unless it was guaranteed to make us lots of money. After all, our publications are well-known for the standards they deliver – standards of living for our publishing executives, that is…"
Disclosure of Phoni's funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist. Elsleazier acknowledged that Phoni had sponsored the publication, but did not disclose the amount the drug company paid.
The spokesperson added that Elsleazier had no plans to look further into the matter. “The high prices of subscriptions to our journals are a guarantee of their quality,” he said. “After all, everyone recognises the quality of Australian scientific publications, in the same way that American diplomacy journals or Nigerian accountancy and banking magazines are regarded…”
One of the genuine members of the Australian Journal of Boneheads and Joint Medicine's "Honorary Editorial Board," Dr. Táké Bakhandar, a rheumatologist in Australia, said he was delighted to serve on the board, however. Dr. Bakhandar has been on Phoni's Asian Pacific and international advisory boards since the mid 1990s, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen.
"You get involved in a whole bunch of things at this level," he said, adding that he had put his name on "quite a few advertorials" for pharmaceutical companies in the past 10 years. “I’m delighted to be able to promote the life-enhancing products of the pharmaceutical industry,” Dr. Bakhandar said.
His colleague and fellow member of the Australian Journal of Boneheads and Joint Medicine's Honorary Editorial Board, Dr. Pádme Baksheesh, agreed. “My own observations conclusively show that there is a direct relationship between the number of products I plug for pharmaceutical companies, and the degree to which my life is enhanced,” he said.
Rich Pillager, Head of Global Marketing for Phoni Pharm. Inc. was also unrepentant.
“The Australian Journal of Boneheads and Joint Medicine” is an important tool in Phoni’s CME (Continuing Medical Education) programme,” he said.
“After all, we’ve been putting out advertorials for years. Everyone remembers our series of children’s books that were designed to promote the use of Phoni’s SSRI Saloadatat in children, for example,” Pillager notes, referring to the controversial “Mr. Bipolar” book based on the
“Our competitors have been doing exactly the same thing, only we’re aiming our latest fairy tales at the adult market. I can’t see what the problem is,” he frothed rabidly.
A related tale from the real world is recounted here. And it would also seem that a so-called scientific publisher in the parallel universe of reality has some “previous” when it comes to controversy...
A fishy tale
A 2cm long fish apparently found it's way into the penis of a 14-year-old boy from India in a bizarre medical case.
The patient was admitted to hospital with complaints of pain, dribbling urine and acute urinary retention spanning a 24-hour period. According to the boy, the fish slipped into his penis while he was cleaning his aquarium at home.
Professor Vezhaventhan and Professor Jeyaraman, who treated the boy and later wrote a paper on the case, explained: "While he was cleaning the fish tank in his house, he was holding a fish in his hand and went to the toilet for passing urine. When he was passing urine, the fish slipped from his hand and entered his urethra and then he developed all these symptoms."
After detecting the fish in the boy's bladder, Vezhaventhan and Jeyaraman used a technique known as cystourethroscopy to insert a special set of forceps down the patient's penis. Unfortunately, the fish was just too slippery to grip, so they resorted to using a rigid ureteroscope with a tool attached that is normally used for removing bladder stones.
The fish the urologists removed, which Practical Fishkeeping believes to be a small member of the Betta genus, measured 2cm long and 1.5cm wide.
He was later admitted into counseling to help him overcome any trauma.
Fat cat special - Big Pharma CEO pay
1. Bill Weldon - Johnson & Johnson - $29.4M
2. Miles White - Abbott Laboratories - $28.3M
3. Bernard Poussot - Wyeth - $25M
4. Jim Cornelius - Bristol-Myers Squibb - $25M
5. Richard Clark - Merck - $19.9M
6. Robert Parkinson - Baxter International - $16M
7. David Vasella - Novartis - $15.1M
8. Jeffrey Kindler - Pfizer - $14.8M
9. Frank Baldino - Cephalon - $14.5M
10. John Lechleiter - Eli Lilly - $13M
11. Fred Hassan - Schering-Plough $12.9M
12. Robert Coury - Mylan $12.5M
13. Werner Wenning - Bayer - $4.8M
14. David Brennan - AstraZeneca - $4.7M
15. Severin Schwan - Roche - $4.5M
Hat tip: Fierce Pharma
2. Miles White - Abbott Laboratories - $28.3M
3. Bernard Poussot - Wyeth - $25M
4. Jim Cornelius - Bristol-Myers Squibb - $25M
5. Richard Clark - Merck - $19.9M
6. Robert Parkinson - Baxter International - $16M
7. David Vasella - Novartis - $15.1M
8. Jeffrey Kindler - Pfizer - $14.8M
9. Frank Baldino - Cephalon - $14.5M
10. John Lechleiter - Eli Lilly - $13M
11. Fred Hassan - Schering-Plough $12.9M
12. Robert Coury - Mylan $12.5M
13. Werner Wenning - Bayer - $4.8M
14. David Brennan - AstraZeneca - $4.7M
15. Severin Schwan - Roche - $4.5M
Hat tip: Fierce Pharma
Quote of the week - and It's only Monday morning!
"When you marry the devil's daughter don't be surprised when your father-in-law comes to visit."
Corey Nahman writes:
A Celebrity Patient's Backing Turns Sour for Drug Company … wasn't the truth, he says now. Within weeks of taking Abilify, Mr. Behrman says he felt stiffness and agitation in his legs. He says Abilify clouded his thinking. He now says the drug made him feel worse than any treatment he has tried…[Wall Street Journal]
Editor's Note: Sequence of events: (A) Bristol hires author/bipolar patient to tell the world how great Abilify is, pays him $10K per day in speaking fees and he tells everyone it is the best thing since sliced bread.(B) His contract is over and he demands $7.5 million to renew; BMS tells him to shove it.(C) Now he's going around saying that he lied all along and Abilify hade him feel like crap.Bottom Line: When you marry the devil's daughter don't be surprised when your father-in-law comes to visit.
Corey Nahman writes:
A Celebrity Patient's Backing Turns Sour for Drug Company … wasn't the truth, he says now. Within weeks of taking Abilify, Mr. Behrman says he felt stiffness and agitation in his legs. He says Abilify clouded his thinking. He now says the drug made him feel worse than any treatment he has tried…[Wall Street Journal]
Editor's Note: Sequence of events: (A) Bristol hires author/bipolar patient to tell the world how great Abilify is, pays him $10K per day in speaking fees and he tells everyone it is the best thing since sliced bread.(B) His contract is over and he demands $7.5 million to renew; BMS tells him to shove it.(C) Now he's going around saying that he lied all along and Abilify hade him feel like crap.Bottom Line: When you marry the devil's daughter don't be surprised when your father-in-law comes to visit.
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