Swiss pharmaceutical giant Novartis said Tuesday that it is cutting 1,400 jobs in the United States as it restructures its general medicines field team in the face of expiring patents.
Tuesday, November 30, 2010
Novartis to cut 1,400 jobs in the US - Yahoo! News UK
Parkinson’s medication turned man into sex-crazed transvestite | swns.com
Town councillor Pete Shepherd, 60, was given a new drug called Cabergoline by his GP after he was diagnosed with Parkinson’s Disease.
The pills relieved the symptoms of the debilitating illness but turned Pete into a high-living, violent, attention-seeking, sex-addicted gambler with delusions of grandeur.
He maxed-out 15 credit cards, exceeded two bank overdraft limits, ran up £400,000 debts and lost his wife, £50,000-a-year IT job and home.
Pete claims he was sent ”mad” by the drugs which twisted his mind so badly he suffered ”compulsions” which made him a sex-addicted gambler.
He received a conditional discharge at Hull Crown Court in November last year when a Judge accepted medication caused him to commit a £45,000 eBay fraud.
Cabergoline is a new form of drug called Dopamine Agent (DA) and can also be used to increase sex drive.
Peter, from Hull, Yorks., said: ”I started to develop a range of strange obsessions, compulsions and interests.
”I became obsessed with gambling, spending, sexual excess and various fetishes.
”I suffered from delusions of grandeur, exhibitionism, paranoia and hallucinations and became violent and suicidal.
”I was out day and night at racecourses, betting shops, casinos and brothels.
”I developed a transvestite tendency and spent tens of thousands of pounds on ladies’ clothing for myself.
”None of this high-living, gambling, hypersexuality, fetishism, violence or attention-seeking made any sense at the time.
”I knew I was behaving oddly but I was totally driven down these paths and unable to control the compulsions whatsoever.
via swns.com
Tylenol Chief Peter Luther Keeps His Job Despite 11 Product Recalls | BNET
via bnet.com
He also kept his job despite failing to inform Colleen Goggins that he had organized a secret recall of Motrin. Goggins found out about it when she testified to Congress.
Drug Maker Wrote Book by Doctors, Papers Say - NYTimes.com
The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.
“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”
via nytimes.com
Monday, November 29, 2010
Sunday, November 28, 2010
Doctors talk about drug firm payments
The Post-Dispatch tried to contact the highest-paid local doctors included in ProPublica's Dollars for Docs database. A few didn't respond or declined to comment. But most readily discussed the business they do with the pharmaceutical industry. The list below includes those doctors believed to have received at least $100,000 from pharmaceutical companies.
Dr. Anthony H. Guarino • $255,737
Cephalon: $171,800
Eli Lilly: $75,644
Johnson & Johnson: $8,293
Profession • Assistant professor of anesthesiology, Washington University School of Medicine. Treats patients at Pain Management Center at Barnes-Jewish West County Hospital
• Speaks about Amrix (muscle relaxer) and Fentora (pain killer) for Cephalon; Cymbalta (antidepressant) for Eli Lilly; Nucynta (pain killer) for Johnson & Johnson.
• Discloses on his WU Web page and to patients that he makes more than $200,000 annually from pharmaceutical companies.
Response • "A very small percentage of my patients are recommended to try these medications. About 98 percent of (prescriptions) that I write are generic. There are situations where I recognize that brand medications would be superior and in that instance I will prescribe them. But I do let the patient know that I speak for the company, and if they feel there's a conflict of interest, I will not write a prescription for that medicine."
Dr. David Alpers • $155,943
GlaxoSmithKline: $155,943
Profession • William B. Kountz Professor of Medicine and Geriatrics and assistant director of the Center for Human Nutrition at Washington University School of Medicine
• Former chief of the Gastroenterology Division at Washington University School of Medicine
Response • "I'm a little different than others on the list because I don't give talks to peers. I don't do anything to promote drugs.
"Twelve years ago, I was asked by the head of research and development at Glaxo to develop a portfolio of drugs for gastroenterology because they didn't have any at the time. I've been working with them all the way from the chemical of the compounds to phase II studies. None of the drugs I've consulted on are on the market. Right now, I'm deciding the best population to use these drugs."
Dr. David Weinstein • $164,295
Eli Lilly: $133,295
GSK: $31,000
Profession • Practices obstetrics and gynecology at Consultants in Women's Healthcare in west St. Louis County
• Speaks on Evista and Forteo for Eli Lilly (both osteoporosis drugs)
Response • "For me, it's all about patient care. I'm passionate about making sure physicians are up to date on the latest diagnostic and therapeutic options, including evidence-based guidelines on who to treat and when."
Dr. Scott Arbaugh • $118,412
Eli Lilly: $116,588
Pfizer: $1,824
• Practices with Northwest Psychiatric Associates in O'Fallon, Mo.
Response • Did not respond to a request for comment.
Dr. Anthony J. Margherita • $143,491
Eli Lilly: $122,274
Pfizer: $10,803
Johnson & Johnson: $10,414
Profession • Physical medicine and rehabilitation at West County Spine & Sports Medicine
• Speaks about Cymbalta for Eli Lilly; Nucynta and PriCara for Johnson & Johnson; Celebrex (arthritis medication) and Lyrica (pain medication) for Pfizer.
Response • "I speak for two different companies that have competing products for the same condition, offering me an advantage because I know and understand the data for both. People will ask about both drugs at some events. And my prescribing patterns don't skew toward one product or another."
Dr. Azfar Malik • $149,067
Eli Lilly: $110,293
AstraZeneca: $36,000
Johnson & Johnson: $1,605
Pfizer: $1,169
Profession • Chief of staff and CEO of CenterPointe Hospital in St. Charles
• Practices psychiatry, specializing in addiction and geriatric psychiatry
• Speaks about Zyprexa and Cymbalta for Eli Lilly; Seroquel for AstraZeneca; a long-term injectable technique for Johnson & Johnson; and Geodon for Pfizer
Response • "Recognition of mental illness is very low among general practitioners, so while we're educating about the drugs we're also educating about the conditions.
"The best example is the recognition of bipolar disorder and how to recognize the symptoms and treat it rather than letting it go and have them suffer. There's also been a lot of stigma against mental illness, and pharmaceuticals have helped with that because we can educate doctors — and through them, the public — that these are chemical disorders that can be treated with drugs."
Dr. Paul M. Packman • $116,386
Eli Lilly: $116,386
Profession • Practices psychiatry in Clayton
• Speaks about Cymbalta and Zyprexa (anti-psychotic medication). Also speaks about Namenda (Alzheimer's medication) and Lexapro (antidepressant), both by Forest Pharmaceuticals Inc.
Response • "My patients know that I travel and do this and they know I get paid for it. When I'm away and traveling, my clinical income is zero ...To say what someone is earning, you need to look at it over a several-year period. I think the media has promoted this kind of distortion."
Dr. Rolando A. Larice $117,489
Eli Lilly: $100,483
Pfizer: $8,606
Astra Zeneca: $8,400
Profession • Practices as R. Larice, M.D. & Associates in Chesterfield
• Former principal investigator at Radiant Research Inc. in St. Louis
• Résumé discloses that he's presented 95 speeches for pharmaceutical companies.
Response • Did not respond to calls or e-mails.
Dr. Jerold J. Kreisman • $134,688
Eli Lilly: $100,688
GSK: $34,000
Profession • Practices psychiatry at Allied Behavioral Consultants Inc. in St. Louis
• Co-author of "I Hate You, Don't Leave Me: Understanding the Borderline Personality" and "Sometimes I Act Crazy: Living with Borderline Personality Disorder"
• Spoke about Vivance (an ADD drug) for GlaxoSmithKline; Cymbalta for Eli Lilly
Response • "It's fun to get out of the office and interact with other doctors and see what they're doing. What other doctors experience is always very important, and these days, given how busy we all are, interaction is quite limited ... If they're having particular problems I've had, I think I can help mitigate certain side effects or suggest another drug."
Dr. Adam Sky • $120,352
Eli Lilly: $120,352
Profession • Practices at Psych Care Consultants in St. Louis
Response • Declined to comment.
Dr. Kathryn Diemer • $108,766
Eli Lilly: $104,766
GlaxoSmithKline: $4,000
Profession • Treats patients at Barnes-Jewish West County Hospital
• Clinical director, Bone Health Program at Washington University
• Assistant dean at Washington University School of Medicine
• Speaks about osteoporosis drugs Forteo and Evista for Eli Lilly; Boniva for Roche Therapeutics; Actonel for Warner Chilcott; Reclast for Novartis; and Prolia for Amgen
Response • "Many physicians contact me regularly after meeting me at a program to ask me questions about their patients and how to evaluate and treat them, often saving the patient a trip to St. Louis or an incorrect diagnosis or treatment. I believe I can help even more patients than I can actually see by educating and working with these physicians."
Dr. Richard Anderson and Dr. Greg Mattingly • shared total of $266,365
Eli Lilly: $188,297 (shared by Anderson and Mattingly)
Eli Lilly: $48,118 (Anderson)
GlaxoSmithKline: $6,250 (Anderson)
GlaxoSmithKline: $23,350 (Mattingly)
Johnson & Johnson: $350 (Mattingly)
Profession • Both practice with Midwest Research Group and St. Charles Psychiatric Associates, which are affiliated with each other.
• Since 2001, the group has been involved in more than 40 clinical research trials in adult and pediatric depression, bipolar disorder, schizophrenia, generalized anxiety disorder, ADHD and sleep disorders.
Response • Neither doctor responded to phone calls or a fax.
via stltoday.com
Saturday, November 27, 2010
Do Big Pharma use deceptive practices? Duh!
A coalition of privacy groups and other advocates are asking the Federal Trade Commission to probe whether online health marketers engage in deceptive practices by tracking users across the Web in order to serve them targeted ads.
"Digital marketing raises many distinct consumer protection and privacy issues, including an overall lack of transparency, accountability and personal control, which consumers should have over data collection and the various interactive applications used to track, target, and influence them online (including on mobile devices)," the groups allege in a 144-page complaint filed Tuesday. "The use of these technologies by pharmaceutical, health product, and medical information providers that directly affect the public health and welfare of consumers requires immediate action."
The complaint was brought by the Center for Digital Democracy, Consumer Watchdog, World Privacy Forum and U.S. Public Interest Research Group. They allege that health marketers are violating Web users' privacy by tracking them, without their knowledge, and "gathering details on their interests and activities (and now including offline databases and employing psychographic and demographic analysis), and then plying them with marketing messages precisely honed to a particular illness or condition."
via mediapost.com
Bad Blood Grows Between Swiss Drug CEOs - "A lot of people call it diversification, I call it giving up."
Relations have turned icy between the CEOs of Roche and Novartis as Switzerland's top two drug executives defend their very different strategies to making money in a tough healthcare market.
The climate became frostier last week when Roche's Severin Schwan announced a cost-saving program on the same day that Novartis CEO Joe Jimenez presented his diversification strategy at the group's long-awaited investor day in London.
via abcnews.go.com
It was noticeable that Jimenez was irritated about the timing of the Roche cost-cutting announcement," said Vontobel analyst Andrew Weiss, who attended the London meeting.
The differences go deeper than a matter of timing. Schwan, an Austrian who collected his doctorate in law from the University of Innsbruck, has been dismissive of the sort of approach taken by Novartis, based on expanding into broader product categories.
"A lot of people call it diversification," Schwan was quoted as saying in an interview with the Financial Times. "I call it giving up."
Pfizer Loses in Court ... Again - Ed Silverman writes
The Nevada Supreme Court has upheld a $58 million judgment that was awarded to three Nevada women, who claimed they suffered breast cancer after taking the Prempro hormone replacement therapy made by Wyeth, which is now owned by Pfizer (PFE). The ruling confirms a 2007 decision in favor of Arlene Rowatt, Jeraldine Scofield and Pamela Forrester, who were originally awarded $134 million, but that was later reduced by the trial judge (back story here and here). Forrester and Rowatt, however, have reportedly since passed away.
In explaining the 6-0 decision, Justice Michael Cherry wrote noted that studies dating back to the 1980s found links between breast cancer and the drug. Yet, he wrote, “internal Wyeth documents show that it responded to studies suggesting a possible breast cancer risk by downplaying the risk through public relations campaigns and its sales representatives’ interactions with physicians” (read the ruling here).
via seekingalpha.com
Johnson & Johnson Unit Falls Short of Standards, F.D.A. Says - NYTimes.com
Months after McNeil Consumer Healthcare, a unit of Johnson & Johnson, recalled millions of bottles of Tylenol and other over-the-counter drugs, the division is still plagued with manufacturing flaws, according to the Food and Drug Administration.
via nytimes.com
Friday, November 26, 2010
Novartis - Afinitor: NICE says no - by Ben Adams
Novartis has failed to convince NICE that its revised patient access scheme for Afinitor would make the kidney cancer drug a cost-effective choice for use by the NHS.
Novartis’ Afinitor (everolimus) is being appraised as a second line treatment for advanced renal cell carcinoma (RCC) after the failure of Pfizer’s RCC drug Sutent.Novartis had originally put forward a deal to the Department of Health in which the first course of Afinitor treatment would be free to the NHS with a further 5% discount thereafter.
NICE rejected this in its final appraisal determination (FAD) but Novartis submitted a new patient access scheme - which the Swiss pharma firm has kept under wraps – meaning NICE undertook a second FAD to take into account this new information.
This new scheme was still not enough to sway the cost-effectiveness body, which today rejected it once more.
Sir Andrew Dillon, chief executive at NICE, said: “NICE asked the independent appraisal committee to consider the newly amended patient access scheme and a further cost effectiveness analysis that NICE asked the manufacturer to provide.
“However, the committee felt that there was still too much uncertainty around how cost effective everolimus is to enable the committee to recommend the drug.
“We know that patients with renal cancer want to try all the treatment options and are disappointed not to be able to recommend everolimus as a second line treatment option.”
Clinical evidence suggests that Afinitor increased survival by more than three months compared with best supportive care.
Afinitor was approved in the EU last year as a second line treatment but fits into a busy market.
Pfizer currently markets both Sutent and Torisel for metastatic forms of RCC and GlaxoSmithKline’s Votrient was recently approved by European regulators for the same indication.
The draft guidance on Afinitor is now with consultees and is available at NICE’s website.
http://www.inpharm.com/news/101126/novartis-patient-access-scheme-nice-afinitor
Time is on Termeer's side
Henri Termeer, head of the American biotech company Genzyme, told Le Figaro in an interview that while he is not against Sanofi-Aventis’s $18.5 billion takeover offer in principle, he thinks it should be higher.
Newcomers among Genzyme shareholders, he said, had bought in at between $70 and $72 per share, already above the $69 offered by Sanofi. Asked if his objections were merely a matter of price, he responded with one word: yes.
As Reuters has reported, Genzyme may accept an altered deal structure that included extra payments from Sanofi if the company performed well. The change, known as a contingent value right, or CVR, might be tied to the performance of Genzyme’s drug, Campath, which treats multiple sclerosis, Mr. Termeer said.
“Time is on our side,” he told the French daily, “because our production problems are being resolved.” A Genzyme plant was hobbled by a viral contamination that slowed down the production of two of its more popular drugs.
“If the board doesn’t give its agreement, Sanofi will have to wait until the shareholders’ meeting is held next year,” he said, adding that it would be a “hard path” for the bidder.
Source
Newcomers among Genzyme shareholders, he said, had bought in at between $70 and $72 per share, already above the $69 offered by Sanofi. Asked if his objections were merely a matter of price, he responded with one word: yes.
As Reuters has reported, Genzyme may accept an altered deal structure that included extra payments from Sanofi if the company performed well. The change, known as a contingent value right, or CVR, might be tied to the performance of Genzyme’s drug, Campath, which treats multiple sclerosis, Mr. Termeer said.
“Time is on our side,” he told the French daily, “because our production problems are being resolved.” A Genzyme plant was hobbled by a viral contamination that slowed down the production of two of its more popular drugs.
“If the board doesn’t give its agreement, Sanofi will have to wait until the shareholders’ meeting is held next year,” he said, adding that it would be a “hard path” for the bidder.
Source
Thursday, November 25, 2010
Love and Other Drugs: Confessions of Jamie Reidy, Viagra Salesman - Newsweek
via newsweek.com
Jamie Reidy was an English major at Notre Dame who knew so little about science, he dropped out of chemistry because he was failing. He enrolled in the Army, then in the 1990s landed a job at Pfizer peddling Viagra. His book, Hard Sell: The Evolution of a Viagra Salesman, has been adapted into a new film, Love and Other Drugs, starring Jake Gyllenhaal. Reidy spoke to NEWSWEEK's Ramin Setoodeh about the ups and downs—and ups—of his career.
Pharmaceutical Marketing and the New Social Media | NEJM
Jeremy A. Greene, M.D., Ph.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
Facebook and Twitter, the largest social media Web sites, have more than 350 million users worldwide, and surveys indicate that 60% of Americans turn first to the Internet when seeking health-related information.1 It is therefore surprising that the pharmaceutical and medical-device industries have been slow to establish a social media presence. The drug industry allocated less than 4% of the more than $4 billion it spent on direct-to-consumer advertising to Internet outlets in 2008, and only a tiny fraction of that was for social networking sites.2 In the next year, however, the proportion may change substantially.
Since the Pure Food and Drug Act was passed in 1906, control by the Food and Drug Administration (FDA) over drug labels has been one of its most powerful tools for protecting the public’s health. To encourage appropriate use of prescription drugs, the FDA has sought to ensure that promotional statements make claims about approved indications only and neither overstate the benefits nor understate the risks. A major concern has been finding ways to ensure “fair balance,” with adequate attention given to information about risks as well as benefits. When this balance is not achieved, inappropriate promotional statements can contribute to misuse of drugs, with dangerous consequences.
As communications media have evolved, manufacturers have tended to wait for the FDA to establish explicit codes of acceptable marketing practices before devoting substantial resources to a new medium. Direct-to-consumer advertising in print media proceeded tentatively until the FDA issued a guidance document in 1985 establishing a standard format for providing a “brief summary” of risks.3 Prescription-drug advertising in broadcast media was similarly minimal until the FDA’s guidance revised the definition of “adequate” risk information in 1997, and again in 1999, to permit broadcast media to include references to a toll-free number or Web site where consumers could obtain more detailed descriptions of a product’s adverse effects. In the wake of these FDA actions, spending on direct-to-consumer advertising mushroomed from $579 million in 1996 to $1.3 billion in 1998 and to over $4 billion in 2008.
In November 2009, the FDA convened a public hearing to discuss pharmaceutical promotion through Web-based social media,4 which present some new challenges. First, it is unclear how to provide fair balance in the dynamic and expanding matrix of networked media — not to mention in a 140-character Twitter post. For static Web sites, manufacturers had been using a “one-click rule,” ensuring that risk information was no further away than a single tap of the finger. This approach remains controversial; in April 2009, the FDA issued warning letters to 14 manufacturers who sponsored search-engine ads for prescription drugs in which there was no obvious connection to a statement of risks. In addition, there is growing concern about the effectiveness of the strategy: the mere possibility of access to risk information does not necessarily translate into a realistic presentation of risks.
Another important consideration regarding Web-based social media is that manufacturers may lose control over the content of the promotional message. Companies may intend to draw a line dividing their own media (such as a company Web site or a company-initiated chat area) from other online discussions of their products. But even if such a distinction were feasible, it would still be possible for manufacturers to support third-party bloggers, posters, and Twitter users who make flattering claims and discredit negative claims about their products in online discussions. Furthermore, the proposed distinction may no longer be technically possible, since entrepreneurs have effectively blurred the line between company-controlled Web sites and the general blogosphere. Google, for instance, with its “Sidewiki” application, can layer a social network of commentary onto any existing static Web site, with or without the site owner’s consent.
The FDA may reasonably conclude that fair balance in Web-based social media cannot be implemented in a way that is compatible with public health needs, and it may try to ban pharmaceutical promotion entirely from these media. If, as media analysts predict, the agency instead issues new guidance, there will probably be an explosion of marketing in online social media, as there was in print media in the 1980s and broadcast media in the 1990s. We believe there are three aspects of pharmaceutical promotion in new social media to which physicians should pay special attention.
First, there is a dearth of research on the clinical and public health impact of communication about drugs. Such work should not be led solely by entities with financial interests in its outcome. Since the FDA hearing last November, an industry-funded, Internet-based social network called #FDASM has been maintaining an active Twitter feed and has been actively soliciting empirical research to justify recommendations for FDA-sanctioned Web 2.0 promotional activity. As medical messages on social media become increasingly available to patients, clinicians will need to better understand the impact of these media, especially in terms of product promotion.
Second, it is crucial to address the problem of disclosure of financial interests in social media. Although most Internet users can often (but not always) find data on drugs’ risks and benefits within a few keystrokes, it is hard to determine whether the source is credible and disinterested. It is now recognized that the ghostwriting of medical research articles can have important public health implications; financial disclosures should be just as explicit for leading providers of social media content as for authors of articles in peer-reviewed journals.
Third, physicians and consumers should hold the FDA and pharmaceutical manufacturers responsible for maintaining credible information in social media regarding the benefits and risks of therapeutic products. One suggestion that emanated from the FDA hearing was a call for a digital FDA “seal of approval” that would identify FDA-reviewed content in posts and discussion threads and provide a hyperlink to pages with FDA-approved content. But this approach would address only a fraction of potential therapy-related claims, and the FDA lacks the resources to police all health-related marketing in social media. Manufacturers are in a better position to monitor online discussions about their products: most U.S. companies that depend on copyright and trademark recognition currently engage in brand-protection activities through aggressive surveillance and litigation.
Debate over the regulation of these new media harkens back to days when a different seal of approval — that of the American Medical Association (AMA) — was placed in medical journals next to drug advertisements that had met rigorous informational standards. The AMA’s Seal of Acceptance program ran from 1929 to 1955 and became the strongest tool for regulating pharmaceutical promotion during that period. Social media of the 21st century are far more complex. Given the potentially important health implications of drug promotion in these media, regulators and manufacturers will have to share the responsibility for oversight.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Source Information
From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston.
References
- Fox S, Jones S. The social life of health information: Americans’ pursuit of health takes place within a widening network of both online and offline sources. Washington, DC: Pew Internet & American Life Project, June 11, 2009. (http://www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information.aspx.)
Arnst CA. Why drugmakers don’t Twitter. BusinessWeek. November 19, 2009. Greene JA, Herzberg D. Hidden in plain sight: marketing prescription drugs to consumers in the twentieth century. Am J Public Health 2010;100:793-803
CrossRef | Web of Science | MedlineDepartment of Health and Human Services, Food and Drug Administration. Promotion of FDA-regulated medical products using the Internet and social media tools. Part 15 public hearing, November 12, 2009. (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm.)
Wednesday, November 24, 2010
Pfizer and the Big Pharma Felons | Center for Media and Democracy
The U. S. Department of Justice recovered $3 billion for American taxpayers as a result of civil suits brought after whistleblowers came forward and reported on pharmaceutical companies' illegal activities. The payout is the largest health fraud settlement in U.S. history. Drug maker Pfizer pled guilty to felony violations of the Food, Drug and Cosmetic Act and was fined $2.3 billion (yes, "billion" with a "b") for aggressively marketing its painkiller Bextra far beyond uses approved by the U.S. Food and Drug Administration (FDA). Bextra was pulled from the market in 2005 due to safety risks. Astra Zeneca paid $302 million for cajoling doctors into writing prescriptions for unapproved uses of its anti-psychotic drug Seroquel, including treatment of insomnia, anger management and post-traumatic stress disorder. Astra Zeneca also paid kickbacks to doctors as part of the illegal scheme to market the Seroquel for unapproved uses. The government also recouped $192 million from Novartis and $108 million from the Health Alliance of Greater Cincinnati and its former member-hospital, The Christ Hospital, for misconduct under the health care Anti-Kickback Statute.
via prwatch.org
What the .....? J&J Recalls More Tylenol Products Over Labeling - WSJ.com
Johnson & Johnson, which has been recalling a number of popular over-the-counter medicines, said Wednesday it is withdrawing more Tylenol because of a labeling problem.
The company's McNeil Consumer Healthcare unit is recalling nearly 9.3 million bottles of three Tylenol Cold Multi-Symptom products from drug stores and suppliers because the bottles' front labels didn't show they contain small amounts of alcohol from ingredients that flavor the medicine.
via online.wsj.com
FDA criminal investigations chief resigns
WASHINGTON — The head of the Food and Drug Administration's criminal investigation unit is stepping down, months after the latest round of criticism directed at his department by congressional investigators.
An agency spokeswoman confirmed Tuesday that Terry Vermillion told FDA staff this week that he would step down.
"We appreciate Terry's years of public service and wish him well in retirement," said FDA Associate Commissioner Beth Martino. Vermillion, who spent 20 years in the Secret Service before joining the FDA in 1992, is among the highest paid officials at the agency at roughly $200,000 per year. His department has been the subject of several investigations requested by federal lawmakers.
Earlier this year the Government Accountability Office said that the FDA must exercise more oversight over Vermillion's unit, which has operated largely independent of agency leadership, despite growing into a $41 million operation with 230 staffers over the last decade. In 2008, House and Senate Republicans questioned the priorities of the criminal investigations unit, specifically its focus on drug abuse cases instead of broader misconduct by large companies.
"I hope that with new leadership, this office will contribute more to the FDA's overall mission of protecting public safety," said Sen. Charles Grassley, R-Iowa, in a statement Tuesday evening. Grassley requested the GAO investigation of FDA's criminal investigation unit.
In September, Grassley brought to light additional complaints against Vermillion in a letter to the GAO.
Grassley said that an anonymous FDA whistleblower contacted his office complaining that the GAO's findings were "less than stellar" and did not include a number of questionable practices by Vermillion.
The whistleblower alleged that Vermillion directed that reports "be changed to sanitize them of derogatory information" about former colleagues from the Secret Service now working at the FDA. Additionally, the whistleblower said Vermillion used support staff to perform personal tasks for him and often directed department operations from his home in Hampton, Va.
Multiple calls placed to Vermillion's office and e-mails seeking comment were not returned Tuesday evening.
The FDA's Office of Criminal Investigations probes cases involving product tampering, counterfeit drugs, illegal marketing and other criminal activities that fall under the FDA oversight.
_
Letter From Sen. Grassley Outlining Allegations of Misconduct
__
Love in the time of pharmaceuticals: Hathaway, Gyllenhaal make ‘Love and Other Drugs’ worthwhile
via toledoblade.com
Where Love and Other Drugs really stands out, though, is with its rather progressive commentary about our times — our need for cure-all pills, and a system (pharmaceutical and insurance companies and physicians) designed to exploit that. Turns out there is a serious message tangled up in this "she loves me, she loves me not" madness.
None of this would matter if the film and its cast weren’t so likable, especially Jake Gyllenhaal and Anne Hathaway.
Tuesday, November 23, 2010
Docs gain big bucks from drugs, devices - BostonHerald.com
“There’s the potential for bias, and the potential for the increased cost of care,” said Tufts Medical School professor Dr. Jerome Kassirer, “but the biggest concern is that the public just won’t trust their doctors anymore.”
Just under $35.7 million was paid out. Of that, about 46 percent — approximately $16.4 million — was paid to 5,048 physicians licensed in the Bay State, Department of Public Health officials said. Those doctors represent about 15 percent of Massachusetts physicians.
via bostonherald.com
Drug Industry Settlements In 2010 Largest Ever Under False Claims Act : Shots - Health News Blog : NPR
This year's biggest hauls under the False Claims Act include $669 million of the record-shattering $2.3 billion total the government took from Pfizer over its improper promotion of the painkiller Bextra, $302 million from Astra Zeneca over the anti-psychotic drug Seroquel, and $192 million from Novartis.
via npr.org
J&J Recalls Children's Benadryl, Motrin From Wholesale, Retail Locations - Bloomberg
Johnson & Johnson, the largest maker of health-care products, has recalled about 4 million packages of cherry- and grape-flavored Children’s Benadryl allergy tablets and about 800,000 bottles of junior-strength Motrin caplets.
The recall was necessary due to “insufficiencies in the development of the manufacturing process,” Bonnie Jacobs, a J&J spokeswoman, said today in a telephone interview. The recalls are taking place at wholesale and retail locations and don’t require any action by consumers, she said.
J&J’s McNeil unit withdrew more than 40 types of children’s over-the-counter liquid medicines in April, forcing a suspension of production at a manufacturing plant and reducing 2010 sales about $600 million, the New Brunswick, New Jersey-based company said in July. The U.S. House Oversight and Government Reform Committee has been investigating J&J’s handling of the recall and a separate incident involving Motrin tablets.
“Consumers can continue to use the product, they don’t have to take any action,” Jacobs said of the Benadryl and Motrin recalls. The action “is not being taken on the basis of adverse events,” or safety issues, she said.
The J&J unit posted a notice Nov. 15 about the recall on the Benadryl Web site, though it didn’t issue a press release, Jacobs said. The products being recalled are Children’s Benadryl allergy Fastmelt tablets, in cherry and grape flavors, and junior-strength Motrin caplets, 24 count, according to the company’s Web site.
The Benadryl tablets were distributed in the U.S., Canada, Puerto Rico, Belize, Barbados, St. Martin and St. Thomas while the Motrin was distributed in the U.S., the company said on its Web site.
To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net
To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net
via bloomberg.com
Monday, November 22, 2010
Who Will Make the First Pharma M&A Move? - WSJ.com
It's clear that big pharma will face a triple whammy of problems—patent expiry, regulation and health-spending restrictions—in the coming years, and large-scale mergers and acquisitions should come back onto the agenda after a relatively quiet 2010.
But midsize players may be waiting for one of the big guns to make a move before pulling the M&A trigger themselves. The problem is, some of the largest pharmaceutical companies—Pfizer, Switzerland's Roche Holding and Merck & Co. of the U.S.—are busy integrating major acquisitions done in 2009.
A report from Moody's lists increasing exposure to major patent expiries, high regulatory hurdles to drug approval and "austerity" measures as health care is reformed around the world as three key reasons why the ratings agency has a negative outlook on the industry as a whole.
Meanwhile, "2009 saw three big M&A moves, and the companies involved are still in the process of digesting these acquisitions," says Moody's senior analyst Marie Fischer-Sabatie. Nevertheless, Moody's expects more M&A next year as companies grapple with these problems.
Interestingly, the agency says debt will likely be a major source of financing. "We have seen some levering up over the past year, and this has generally translated into ratings downgrades. But pharma is still under-levered compared with other industries," says Ms. Fischer-Sabatie.
The key additional question is how much headroom for debt-financed takeovers the likes of Pfizer, which has gross debt of 1.9 times reported earnings before interest tax, depreciation and amortization, still have. Patent issues may be pressing, but there is far less of a cushion now to fund M&A without credit-rating consequences, says Moody's.
Given that many of the industry's players take their cue from the U.S. giant, this could prove to be another stumbling block.
Roche could be another leading indicator. "Small bolt-on acquisitions could be accommodated within [Roche's] A2 rating category, but we would expect the company to focus on deleveraging" following its $46.8 billion purchase of Genentech, Ms. Fischer-Sabatie says.
So is it the case that all the main players know they'll be hit by patent expirations and a thin pipeline over the coming years, and realize that if they do nothing they'll just struggle together and the status quo will be maintained? That's probably too cynical a view.
But it's a fact that Eli Lilly & Co and U.K.-based GlaxoSmithKline—whose exposure to patent expiries and challenges over the next three years amounts to 40% and 32% of group sales, respectively—have been resolute in their rejection of M&A as a means of growing their way out of trouble.
Where does Ms. Fischer-Sabatie expect consolidation to take place? Generics and consumer health as pharma tries to diversify, as well as emerging markets and vaccines businesses.
—Jacob Plieth
via online.wsj.com
Department of Justice Recovers $3 Billion in False Claims Cases in Fiscal Year 2010
Department of JusticeOffice of Public AffairsFOR IMMEDIATE RELEASEMonday, November 22, 2010Department of Justice Recovers $3 Billion in False Claims Cases in Fiscal Year 2010$2.5 Billion Health Care Fraud Recovery Largest in History — More Than $27 Billion Since 1986WASHINGTON - The Department of Justice secured $3 billion in civil settlements and judgments in cases involving fraud against the government in the fiscal year ending Sept. 30, 2010, Tony West, Assistant Attorney General for the Civil Division, announced today. This includes $2.5 billion in health care fraud recoveries—the largest in history—and represents the second largest annual recovery of civil fraud claims. Moreover, amounts recovered under the False Claims Act since January 2009 have eclipsed any previous two-year period with $5.4 billion in taxpayer dollars returned to federal programs and the Treasury. Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $27 billion.
"Under Attorney General Eric Holder’s leadership, our aggressive pursuit of fraud under the False Claims Act has resulted in the largest two-year recovery of taxpayer dollars in the history of the Justice Department," Assistant Attorney General West said. "Nowhere is this more apparent than in our success in fighting health care fraud. Since January 2009, the Civil Division, together with the U.S. Attorneys’ offices, commenced more health care fraud investigations, secured larger fines and judgments, and recovered more taxpayer dollars lost to health care fraud than in any other two-year period."
Fighting fraud committed against public health care programs is a top priority for the Obama Administration. On May 20, 2009, Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS), announced the creation of a new interagency task force, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to increase coordination and optimize criminal and civil enforcement. These efforts not only protect the Medicare Trust Fund for seniors and the Medicaid program for the country’s neediest citizens, they also result in higher quality health care at a more reasonable price.
The record health care fraud civil recoveries of $2.5 billion announced today made up 83 percent of the year’s total civil fraud recoveries. HHS reaped the biggest recoveries, largely attributable to its Medicare and Medicaid programs. Recoveries were also made by the Office of Personnel Management, which administers the Federal Employees Health Benefits Program, the Department of Defense for its TRICARE insurance program and the Department of Veterans Affairs, among others.
Assistant Attorney General West noted that since January 2009, the Civil Division, together with the U.S. Attorneys’ offices, set a two-year record for health care fraud enforcement efforts, recovering $4.6 billion in taxpayer funds under the False Claims Act from health care providers and others in the industry, and securing 25 criminal convictions as well as more than $3 billion in fines, forfeitures, restitution and disgorgement under the Food, Drug and Cosmetic Act (FDCA).
The False Claims Act cases successfully resolved this year not only included payment schemes implicating federal health care programs, but also wartime and other government procurement contracts; grants for small businesses, bullet-proof vests for law enforcement, and other purposes; federally insured mortgages; federal and Indian mineral leases; and many other federal programs.
Assistant Attorney General West commended the substantial efforts of the Civil Division’s career attorneys, the U.S. Attorneys’ Offices, and the federal and state agencies that investigate and support False Claims Act prosecutions, remarking that "their dedication and the cooperation we enjoy allow us to bring all of our resources to bear in combating fraud against both the federal and state governments."
Most of the cases resulting in recoveries were brought to the government by whistleblowers under the False Claims Act, the federal government’s primary weapon in the battle against fraud. In 1986, Senator Charles Grassley and Representative Howard Berman led successful efforts in Congress to amend the False Claims Act to revise the statute’s qui tam (or whistleblower) provisions, which encourage whistleblowers to come forward with allegations of fraud. Assistant Attorney General West paid tribute to the 1986 amendments’ sponsors, saying: "Without their foresight, these recoveries would not have been possible." He also expressed his gratitude to Senator Patrick J. Leahy, Chairman of the Senate’s Judiciary Committee, and to Senator Grassley and Representative Berman for their support of the Fraud Enforcement and Recovery Act of 2009, which made additional improvements to the False Claims Act and other fraud statutes.
Of the $3 billion in settlements and judgments obtained in fiscal year 2010, over $2.3 billion was recovered in lawsuits filed under the False Claims Act’s qui tam provisions. Under these provisions, whistleblowers (known as "relators") – many of whom face considerable personal risk in coming forward with allegations of fraud –are entitled to recover between 15 and 30 percent of the proceeds of a successful suit. In fiscal year 2010, relators were awarded $385 million. Since 1986, when the qui tam provisions were strengthened by Congress, recoveries in qui tam cases have exceeded $18 billion, and relators have obtained more than $2.8 billion in awards.
Assistant Attorney General West also applauded Congress’ passage this past year of the Affordable Care Act (ACA), which included additional provisions to aid the Government in redressing fraud on the nation’s health care system, and to promote incentives for whistleblowers to disclose fraud to the government. Among many other changes, the ACA amended the False Claims Act’s public disclosure provision and strengthened the provisions of the federal health care Anti-Kickback Statute.
Fiscal year 2010 also saw records for several types of health care fraud. A $2.3 billion settlement with Pfizer Inc. marked the largest health care fraud settlement in history. The $2.3 billion includes $669 million recovered under the federal False Claims Act, $1.3 billion in criminal fines and forfeitures, and $331 million in recoveries for state Medicaid programs and the District of Columbia. (These latter two amounts are not included in the total health care fraud recoveries announced today, which are limited to the federal government’s civil recoveries.) In addition, a $108 million settlement with The Health Alliance of Greater Cincinnati and one of its former member hospitals, The Christ Hospital, was the largest ever under the health care Anti-Kickback Statute for the conduct of a single hospital.
The largest fiscal year 2010 False Claims Act recoveries came from the pharmaceutical and medical device industries, which accounted for $1.6 billion in settlements, including the $669 million from Pfizer Inc., $302 million from AstraZeneca, and $192.7 from Novartis Pharmaceutical Corporation.
In addition to the civil health care fraud recoveries under the False Claims Act, the Civil Division’s Office of Consumer Litigation (OCL) brings civil and criminal actions for violations of the FDCA. Together with their partners in the U.S. Attorneys’ Offices around the country, OCL pursues such matters as the unlawful marketing of drugs and devices, fraud on the FDA, and the distribution of adulterated products. In fiscal year 2010, those efforts yielded more than $1.8 billion in criminal fines, forfeitures, restitution and disgorgement, the largest health care-related amount under the FDCA in department history. Since January 2009, OCL has successfully pursued cases resulting in 25 criminal convictions and more than $3 billion in fines, forfeitures, restitution and disgorgement.
In addition, the Civil Division continues to play a leading role in the Financial Fraud Enforcement Task Force, created last November by President Obama to improve the federal government’s efforts to investigate and redress consumer and financial fraud. The Civil Division, in conjunction with its partners on the task force, is aggressively pursuing all manner of financial fraud schemes, including mortgage fraud, non-war related procurement fraud, and fraud involving the Troubled Asset Relief Program, the American Recovery and Reinvestment Act and other economic stimulus funds. False Claims Act recoveries in these cases accounted for 11 percent of fiscal year 2010 recoveries, with $327.2 million in settlements and judgments.
The Civil Division also pursues fraud claims related to contracts in support of the wars in Iraq and Afghanistan. During fiscal year 2010, the Civil Division recovered $10.6 million in these cases. To date, settlements and judgments in procurement fraud cases involving the wars in Southwest Asia total $137.2 million. Of this amount, $114.7 million has been recovered since January 2009.
via justice.gov
Irish drug industry fears bailout tax terms
Any increase in Ireland's corporation tax rate as part of a financial bailout could hurt the country's rapidly expanding pharmaceutical industry, currently its largest contributor to corporation tax.
Ireland is in talks with the European Union and the International Monetary Fund regarding a potential rescue package to stabilise the Irish banking system and protect the euro. So far Irish leaders have ruled out any increase in its corporation tax rate as part of the deal. But media reports have suggested that member states may try to force an increase to guarantee a return on their investment.
Ireland's corporation tax rate of 12.5 per cent is amongst the lowest in Europe. A spokesperson for the Irish Pharmaceutical Healthcare Association (IPHA) says: 'Corporation tax is very important to the industry. It is one of the primary reasons why the industries came to Ireland and continue to invest in the Irish economy.' Indeed, 13 of the largest 15 pharma companies, including Bayer, Pfizer, GlaxoSmithKline, AstraZeneca and Roche have at least one manufacturing site there. This has helped Ireland become the second largest net exporter of medicines in the world.
via rsc.org
Novartis says no plans to cut thousands of jobs | Reuters
Sunday newspaper Sonntag said Novartis was planning a cost-cutting programme similar to cross-town rival Roche Holding AG (ROG.VX), quoting two unnamed sources close to Novartis management.
"I do not know who the company's sources are but we do not plan a programme similar to Roche's," Novartis spokesman Eric Althoff said.
Roche, the world's biggest maker of cancer drugs, said on Wednesday it would slash 4,800 jobs worldwide, hacking 2.4 billion Swiss francs ($2.5 billion) from annual costs. [ID:nLDE6AF29X]
Novartis, maker of high blood pressure drug Diovan, set out its long-term strategy on the same day but remained tight-lipped about job cuts, only saying it wanted to cut costs in manufacturing, marketing and sales, and procurement, in an effort to improve profitability.
Sonntag reported a massive cost-cutting programme would be announced but Althoff said he could not confirm this information.
via uk.reuters.com
Genzyme considering new deal structure-WSJ | Reuters
Genzyme has been holding internal discussions to consider the use of a contingent value right (CVR), which give shareholders more value if the acquired company hits benchmarks, the Journal reported, citing people familiar with the matter.
This particular CVR would likely be tied to the performance of Genzyme drug Campath, an experimental drug for multiple sclerosis that has already been approved for cancer.
Sanofi has called Genzyme's projection of up to $3.5 billion in peak sales for Campath unrealistic. Genzyme has dismissed Sanofi's $69 per share bid as too low.
via uk.reuters.com
Sunday, November 21, 2010
FT.com - Pharma becomes target for organised crime
Rising demand in the US for costly medicines since the economic downturn has helped make pharmaceutical shipments a growing target for organised criminal gangs.
Data from FreightWatch, a US based freight security consultancy, shows at least 41 robberies of prescription drugs from trucks and warehouses so far this year, with an average value of nearly $5m. In 2009 it recorded 47 incidents worth $4m each.
via ft.com
The Top 20 Global Pharmaceuticals by Sales -- Seeking Alpha
S.No. Company Ticker 2009 Revenues in US $ (Milllions) 1 Pfizer PFE $45,448 2 Sanofi-Aventis SNY $40,871 3 Novartis NVO $38,455 4 GlaxoSmithKline GSK $36,746 5 AstraZeneca AZN $31,905 6 Merck & Co. MRK $26,929 7 Johnson & Johnson JNJ $22,520 8 Eli Lilly & Co. LLY $20,629 9 Bristol-Myers Squibb BMY $18,808 10 Abbott Laboratories ABT $16,486 11 Takeda Chem Ind. TKPHY.PK $14,204 12 Boehringer-Ingelheim $14,027 13 Teva Pharma TEVA $13,814 14 Bayer Schering BAYRY.PK $13,344 15 Astellas ALPMY.PK $10,509 16 Daiichi-Sankyo DSKYY.PK $9,757 17 Eisai ESALY.PK $8,441 18 Otsuka $7,717 19 Gilead Sciences GILD $6,469 20 Mylan MYL $5,015 Source: Contract Pharma
via seekingalpha.com
Saturday, November 20, 2010
I've had enough. I'm fed up - Dr. Raj Sherman takes responsibility for the public uproar over the emergency crisis
"Do you know why I spoke up? Some poor kid died of a ruptured appendix (while waiting at the Grey Nuns Hospital). As a human being, that hurts. Hurts me when I know that my buddy's brother hung himself in my department (at the Royal Alexandra Hospital) and I'm in government and I didn't fight hard enough or slam my fist hard enough.
"I didn't have the courage to put my neck on the line. But I told these guys, if I hear of another kid dying in the waiting room, somebody better look out."
Big Pharma vs The Pope! - Fight!
VATICAN CITY – The Catholic Church may be the only organization that can counter the corporate greed fueling the over-prescribing of harmful psychiatric drugs to children and young people, said Dr. Barry Duncan, a clinical psychologist and director of the Heart and Soul of Change Project.Flawed methodologies in research and a drastic minimization of actual risks make the cited efficiency and safety of these drugs untrustworthy, he told a meeting of the Pontifical Council for Health Care Ministry.
And clinical trial evidence on psychiatric drugs is often skewed by conflicts of interests, particularly when trials are funded by the drug industry or when the studies are conducted by people who are paid consultants of the company under review, Duncan told the Nov. 18-19 meeting.
He said because of the church’s broad networking capabilities and international influence, it “may be the only power on earth that can counter the forces of corporate greed that have no moral or ethical conscience.”
He called on religious orders, Catholic schools, hospitals, medical associations, media and parishes to become informed and help children and families discover alternatives to psychiatric medications as well as help them have real input when discussing the risks and benefits of such medication.
Duncan spoke Nov.19 on “The Question of the Use of Psychiatric Pharmaceuticals in Pediatrics” during the conference, and he spoke about his findings in a separate meeting Nov. 18 with Cardinal Ennio Antonelli, president of the Pontifical Council for the Family.
Duncan told the conference that the United States leads the world in the number of psychiatric prescriptions to young people and that the trend to resort to antipsychotics before or in lieu of social and behavioral therapy is on the rise in Europe.
Most disturbing, he said, is that poor children in the United States, particularly those in foster care or on Medicaid, are four times more likely to be prescribed antipsychotic drugs and six times more likely to be treated with a number of different psychotropic medications.
Poor children are also “vulnerable to dangerous drugs used as interventions of control rather than therapy,” he said.
Clinical evidence does not support the practice of prescribing pharmaceutical drugs as a first response to behavioral or psychiatric issues, he said, not only because of the drugs’ questionable long-term effectiveness, but also for the risk of serious health consequences, dependence and disability.
“The belief in the power of chemistry over church, community, social and psychological process – fueled by unprecedented promotion from the drug industry that targets all players in health care – forms the basis of pharmacology’s growing centrality in treatment, research, training and practice,” he said.
Children have no voice, and they rely on adult judgments and decisions for their well-being, he added.
Families, pastoral workers, pediatricians and health professionals “need access to accurate data - to the truth untainted by corporate influence,” Duncan said.
Viagra - The Movie! : Edward Zwick’s ‘Love and Other Drugs’
via nytimes.com
Adapted from Jamie Reidy’s best-selling memoir about the Viagra gold rush in the late 1990s, it stars Jake Gyllenhaal as a womanizing pharmaceutical representative who falls in lust, and then in love, with a beautiful young woman (Anne Hathaway) with Stage 1 Parkinson’s disease. It would be a plunge deep into disease-of-the-week territory, if not for the raunch — sex scenes, sex tapes, nudity, an orgy — that Mr. Zwick has seasoned the film with and that may leave some in the audience wondering whether they are watching a film about Viagra, or on Viagra.
Merck Not at Fault in Fosamax Trial, Jurors Decide - NYTimes.com
Friday’s verdict comes at a time when many physicians are rethinking the long-term use of Fosamax and other osteoporosis drugs known as oral bisphosphonates. Last month, the Food and Drug Administration issued a public advisory saying the drugs had been linked with — although not definitively as the cause of — rare thigh fractures. The agency will now require the labels of oral bisphosphonates to state that the optimum duration of taking the drugs is not known
via nytimes.com
Friday, November 19, 2010
NHS fares best on free access to healthcare | Society | The Guardian
Britain's health service makes it the only one of 11 leading industrialised nations where wealth does not determine access to care – providing the most widely accessible treatments at low cost among rich nations, a study has found.
The survey, by US health thinktank the Commonwealth Fund, showed that while a third of American adults "went without recommended care, did not see a doctor when sick, or failed to fill prescriptions because of costs", this figure was only 6% in the UK and 5% in Holland.
In all the countries surveyed except Britain, wealth was a significant factor in access to health, with patients earning less than the national average more likely to report trouble with medical bills and problems getting care because of cost.
via guardian.co.uk
Darvon, Darvocet Painkillers Will Be Withdrawn in U.S. Over Heart Risks - Bloomberg
For the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” he said in the statement.
via bloomberg.com
Martha Rosenberg writes: Pediatric Zyprexa Brochures Embarrass British Health Service
For OpEdNews: Martha Rosenberg - Writer
"Your medicine is called Olanzapine. Pronounced 'o-lan-za-peen,'" says the lime green kids' brochure for the antipsychotic Zyprexa, published by Britain's National Health Service (NHS). "Many children, teenagers and young people need to take medicines prescribed by doctors to help them stay well and healthy," says the text amid cartoons of happy children skating, roller blading and playing soccer.
Similar brochures educate children about "ris-perry-done" (Risperdal), another antipsychotic and "ato-mox-e-teen" (Strattera), an ADHD drug. But when mental health advocate Ben Hansen tried to "educate" US children further by posting the brochures on his web site bonkersinstitute.org, he got a love letter from the NHS.
"I have been informed that you are using our leaflets on your web-site," wrote Deputy Chief Pharmacist with the Central and North West London NHS Trust Sue Eccles in an email this month. "Our objective is [sic] provide written materials to support the verbal counselling given by healthcare professionals -- they are not meant to stand alone as sources of information," says Eccles requesting that only the "front page and our contact details," be shown.
Unfortunately, the NHS caught Hansen on a day he didn't take his meds. "We posted the NHS leaflets to stimulate public scrutiny of your agency," replied Hansen, who writes under the pseudonym Methodius Isaac Bonkers, MD. "We call upon the NHS to stop promoting harmful psychotropic drugs for children. In a spirit of full disclosure and transparency, we have now posted your letter as well."
No wonder Hansen's four-year-old site, the Bonkers Institute, is considered a leader in sunshine activism. Hansen's zeal for unearthing and posting pharma sleight-of-hand even landed him on the front page of the New York Times two years ago in an article called,
"In Some States, Maker Oversees Use of Its Drug."
Twenty states take advantage of the Pharmacy Quality Improvement Project, a "free" program from Eli Lilly that shows states how to save money on...drugs from Eli Lilly. But Hansen, says the Times "obtained documents through a Freedom of Information request that showed a Lilly account executive had asked to take part in planning sessions and offered to have Lilly representatives brief doctors."
Lilly dropped the program in states daring to require doctors to seek permission to prescribe Zyprexa which at $300 a month is the single biggest drug cost for state Medicaid budgets according to the Times.
Hansen also received FOIA documents from the state of Michigan showing the number of psychiatric drugs prescribed to children under 6 and the number of Medicaid patients on 5 or more psychiatric drugs but they did not name the drugs.
How does pharma vault a drug only indicated for the one percent of the population with schizophrenia and four percent with bipolar disorder to be the biggest line item in the Medicaid budget? As in your tax dollars? Just good off-label marketing--promoting a drug for a non-FDA approved use which is illegal in the US.
And speaking of non-approved uses, how can Britain's National Health Service produce a brochure for kids taking Zyprexa when kids are not supposed to take Zyprexa? "ZYPREXA is not for patients who are under 18 years," says the prescribing information. "Keep out of the reach and sight of children."
Are the healthy, active kids shown in the cartoons "befores" since 30 percent of Zyprexa patients gain 22 pounds or more, 16 percent, 66 pounds or more and some gain over 100 pounds according to Lilly's own published data? Zyprexa "may make you feel like eating more food," says the NHS brochure in what might be considered classic British understatement. "If this happens, try not to eat more than usual and talk to an adult or your doctor about this." Any questions?
And how about Zyprexa's notorious soporific effect or zombie factor? "It is a good [sic] to take olanzapine at bedtime, as it can make some people feel sleepy," says the brochure.
Hansen's war on pharma disease mongering comes from first hand experience. He was misdiagnosed with "bipolar disorder" and denied release in a Michigan hospital after a reaction to the death of his father and a suicide of a friend on the same day. "The psychiatrist refused to treat me without drugs," says Hansen and "I was held in the hospital involuntarily for the next 39 days, totaling a bill of $23,000."
Take one look at the Bonkers Institute's gallery of vintage psychiatric drug advertising, the Nearly Genuine and Truly Marvelous Mental Medicine Show--one of the best on the web--and you see the roots of today's pediatric bipolar/depression/ADD/ADHD "epidemic" decades ago. Thorazine syrup was given for vomiting in kids, antidepressants for bedwetting and Ritalin for "mischief" and "juvenile pranks." Like the NHS brochures, kids are shown happy and playing with soccer balls.
via opednews.com
Subscribe to:
Posts (Atom)