Monday, February 28, 2011
Payday! - Supreme Court orders drug industry to pay reps overtime | NJ.com
The U.S. Supreme Court refused to insulate the drug industry from having to pay overtime to thousands of sales representatives, turning away appeals from units of Novartis AG and Merck & Co.
The companies sought to overturn a federal appeals court’s conclusion that their salespeople are covered by a federal wage- and-hour law. The decision against the Novartis unit leaves the company with claims of as much as $100 million on behalf of 2,500 past and current employees.
Drugmakers are facing a wave of suits by sales representatives for overtime pay. More than a dozen suits have been filed, including cases against Johnson & Johnson, Bristol- Myers Squibb Co. and a GlaxoSmithKline Plc unit. Drug companies have long treated sales representatives as exempt from the overtime requirements, according to court papers filed by an industry trade group.
The lower court ruling “threatens untold costs in unforeseen liability,” the Pharmaceutical Research and Manufacturers of America argued in the Novartis case.
The rulings by the New York-based 2nd U.S. Circuit Court of Appeals came in two separate suits—one against Novartis Pharmaceutical Corp. and another against Merck’s Schering unit.
Ruling Overturned
In the Novartis case, a trial judge had ruled that the sales representatives fell under exceptions to the U.S. Fair Labor Standards Act for outside salespeople and administrative workers. The 2nd Circuit overturned that decision on a 3-0 vote.The ruling came after the Labor Department urged the 2nd Circuit to side with the Novartis salespeople.
The Novartis workers told the Supreme Court that the appeals court reached the right conclusion. They argued that the salesperson exemption doesn’t apply to workers, like them, who promote a product without actually making a sale.
The salespeople also contended they don’t exercise enough independence to qualify for the administrative-worker exception. They said they are required to deliver a tightly scripted message when they visit doctors.
“This case involves one company—Novartis—that micromanages its reps and gives them far less discretion than is typical in the industry,” the salespeople’s lawyers argued.
One of the lawyers for the salespeople, Jeremy Heisler of Sanford Wittels & Heisler LLP in New York, said his clients would be seeking about $100 million damages.
The cases are Schering v. Kuzinski, 10-459, and Novartis v. Lopes, 10-460.
via nj.com
Gilead's $12,000-a-Year HIV Prevention Pill Fails to Win Physician Support - Bloomberg
Gilead Sciences Inc.’s Truvada topped Time magazine’s list of medical breakthroughs for 2010 after a study showed it may achieve a goal pursued by scientists for a quarter-century: a pill to prevent HIV infection.
Three months later, the advance has hit a wall. While study findings show the drug prevents HIV in non-infected, sexually active gay men, doctors say they’re wary about giving healthy people a $12,000-a-year medicine that has side effects that can include nausea and kidney damage, and may not be used as regularly as needed. They also say they’re not often asked to make the drug available for that use.
via bloomberg.com
EMA warned of potential “conflicts of interest” involving former exec director - PharmaTimes
The European Medicines Agency (EMA)’s decision to allow its former executive director, Thomas Lonngren, to take up an advisory role within the private pharmaceutical sector - just weeks after leaving his position at EMA - risks conflicts of interest, campaigners have claimed.
In a joint letter sent to John Dalli, the European Commissioner for Health and Consumer Policy, a group of public health and transparency campaigners express concern that the EMA did not adequately follow the procedures outlined in the European Union (EU) Staff Regulations which are designed to prevent undue influence in the medical regulatory process.
Mr Lonngren stepped down as EMA executive director at end-December 2010 and, in a letter dated December 28, he told the chairman of the Agency’s management board, Pat O’Mahony, of his intention to take up a consultant role within the private pharmaceutical sector as of January 1, 2011.
“I am very conscious of my obligations and commitments to the EMA, and can assure you that in my new role there will be no conflict of interest, breach of code of conduct or any of my other legal contractual obligations, as a departing employee of the EMA,” Mr Lonngren tells Mr O’Mahony.
“It is my intention to uphold the reputation of the EMA and myself in a highly professional manner. I hope to support the EMA as much as possible in everything I do,” he writes.
10 days later, Mr O’Mahony wrote back to Mr Lonngren, telling him that the Agency had “no objections to these activities, having regard to your assurances that they do not cause a conflict of interest nor breach the code of conduct or any other aspects of Staff Regulations.”
But prior to approving his future ambitions, the EMA board did not request any further details from Mr Lonngren concerning his activities, or impose any form of restriction to prevent a conflict of interest arising, says the letter to Commissioner Dalli, which is signed by the Alliance for Lobbying Transparency and Ethics Regulation (ALTER-EU), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), the European Consumers’ Organization (BEUC) and the European Public Health Alliance (EPHA).
The groups question the lack of “cooling-off” period between Mr Lonngren’s change of employment, and express concern that this may result in a conflict of interest in the field of medical regulations at the EU level.
“There are currently several high-profile dossiers on pharmaceutical policies under discussion, including the revision of the Clinical Trial Directive, where we have concerns that a conflict of interest may arise involving Mr Lonngren's past and current employment,” they tell Commissioner Dalli, adding: “it goes without saying that a former head of the EU drug regulatory agency has an extensive network and knowledge in the field, and this opens up the potential to influence the outcome of these dossier discussions. We question whether this is appropriate, and suggest that this damages public trust in the regulatory agency.”
To date, Mr Lonngren’s consultancy posts have included working for NDA Advisory Services, an agency that specialises in helping pharmaceutical companies obtain regulatory approval to sell their products in Europe, the signatories note.
According to Katrina Perehudoff of HAI Europe, the EMA “appears to have failed to adequately check the potential for a conflict of interest arising from Thomas Lonngren’s decision to establish his own consultancy and other new jobs,” while Jorg Schaaber of ISDB adds that: “given the very clear overlap between Mr Lonngren’s previous activities and his proposed new roles, surely further questions should have been asked - and some form of restriction imposed.”
“When former EU Commission officials pass through the revolving door - as happens frequently - it is essential that clear checks are made to ensure they are not exploiting their knowledge and contacts to benefit the private sector. All too often such conflicts of interest appear to be overlooked, showing that tougher rules and more rigorous enforcement are required,” says ALTER-EU Alliance spokesman Olivier Hoedeman.
via pharmatimes.com
AZ opens new global HQ in London | InPharm
via inpharm.com
The new offices are located in the Two Kingdom Street development in Paddington Central, and will be home to some 350 members of staff.
It will also accommodate around 90 staff from AstraZeneca’s global sales and marketing divisions, some of whom are relocating from the company’s US and Brussels operations.
EDITORIAL: Iressa drug ruling - asahi.com
The Osaka District Court on Friday ordered the Japanese unit of British drugmaker AstraZeneca Plc to pay compensation to nine of 11 plaintiffs in a suit over side effects caused by the lung cancer drug Iressa.
The district court, however, denied the state's liability, pointing out that the government instructed the company to disclose information about side effects.
Last month, the court recommended a settlement of the case, urging both sides to compromise. It is not unusual that a court's ruling on a legal dispute is not totally in tune with what it said when it recommended a settlement of the case.
When the Osaka court called for a compromise in this case, it said the state was responsible for providing relief for the victims.
It is, therefore, not surprising that the plaintiffs were disappointed at the court's decision not to order the state to pay compensation.
The Tokyo District Court is currently hearing another case concerning Iressa's side effects. It's ruling, scheduled to be handed down next month, will be important.
Of the wide range of issues addressed during the trial, the one that attracted the most attention was how information about the potential risks of a drug should be provided effectively to medical institutions and experts on the assumption that no drug is free from side effects.
Iressa's package insert originally cited four possible "serious side effects." The one cited at the top was "severe diarrhea," and interstitial pneumonia, which was the cause of many deaths from the drug's side effects, was listed last.
Both the drugmaker and the government asserted the order was not important, saying blame for the deaths should be placed primarily on the physicians who prescribed the drug without fully understanding its properties.
Are they right?
In response to a series of deaths from the drug's side effects, an emergency safety warning was issued three months after its approval.
After a highly visible warning that the drug could cause interstitial pneumonia was added at the top of the package insert, the number of cases fell significantly.
This was not the first time package inserts became an issue. Five years before it approved the drug, the health ministry issued a bureau chief directive urging pharmaceutical companies to place important information in upper parts of such documents.
Why did the company fail to comply with the directive? Why did the government fail to take a stronger action to ensure compliance? These questions remain unanswered.
Some people may say these documents are intended for experts who should find such important information wherever it is placed.
However, there was the general perception among experts that Iressa was a good medicine with less side effects mainly because of articles in medical journals.
The district court rightly acknowledged the obligation of a drugmaker to provide information necessary for correct treatments in a way that ensures that the information reaches the "average doctor." This decision is in line with the expectations of the public.
The term "informed consent" has become familiar to the Japanese public.
But ensuring effective informed consent requires doctors to have accurate medical knowledge and address the concerns of their patients head-on.
The Iressa debacle has shown again the importance of tackling the challenge of meeting patients' expectations while securing the safety of new drugs.
Even though it was not held legally liable for the sufferings due to Iressa's side effects, the health ministry, which was criticized by the court for failing to make the best possible response to the problem, has to learn many lessons from the episode.
--The Asahi Shimbun, Feb. 26
via asahi.com
Sunday, February 27, 2011
OxyContin epidemic brings Southern Ohio county to its knees | cleveland.com
At the half-dozen or so pain clinics in this Appalachian county along the banks of the Ohio River, a handful of licensed doctors pump out prescriptions for an estimated 35 million pain pills a year to an ever-mushrooming population of pill-crazed patients who come from near and far just to cop.
Do the math, and it comes to roughly 460 pills for every man, woman and child in this county of 76,000 residents, according to 2008 state pharmacy board statistics.
It's gotten so bad that last year the local health commissioner declared a public health emergency, a rare step usually reserved for disease outbreaks.
Lisa Roberts, a city of Portsmouth public-health nurse on the front lines of the epidemic, says locals call it the "attack of the pill heads." She says a "pharmaceutical atom bomb" has brought the county to the verge of complete social collapse.
via cleveland.com
“Inverse benefit law” explains how drug marketing undermines patient safety --- bmj.com
“Inverse benefit law” explains how drug marketing undermines patient safety
+ Author Affiliations
Drug companies show a clear, repeated pattern in which “drugs discovered with good science for a specific set of patients are marketed to a larger population” for whom they are less appropriate and less safe, says Howard Brody, professor and director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.
The “inverse benefit law” was published online in the American Journal of Public Health (doi:10.2105/AJPH.2010.199844).
Dr Brody told the BMJ, “You have to be really sceptical and careful not be seduced by research findings that are apparently very valid scientifically, but if you drill down they are really industry marketing disguised as research rather than scientifically valid research . . . Scientists in [industry] laboratories never make a move without somebody from marketing being there while they’re planning their research.”
The inverse benefit law echoes Julian Tudor Hart’s “inverse care law,” which says that availability of good medical care varies inversely with the need for it in the population (Lancet 1971;i:405-12).
The inverse benefit law says that patients with the most severe symptoms or the highest level of risk will receive the greatest benefit from treatment with a drug. The risk of an adverse event, however, is spread among all people receiving the drug.
Because only a few people would receive the drug on the basis of evidence based treatment, marketing from drug companies seeks to increase the number of people who should be treated, using six mechanisms:
• Reducing the threshold for diagnosing disease, such as lowering the level for diagnosing type 2 diabetes and hypertension
• Relying on surrogate end points, such as glucose concentrations and blood pressure levels, rather than patient outcomes such as myocardial infarction, stroke, and death
• Exaggerating safety claims (so that doctors prescribed newer antipsychotics more often, for example)
• exaggerating effectiveness claims—as with cyclo-oxygenase-2 inhibitors, which were no better as analgesics than older non-steroidal anti-inflammatory drugs, had only a modestly lower risk of gastrointestinal bleeding, and were later found to raise cardiovascular risks
• creating new diseases, such as social phobia, pre-diabetes, and pre-hypertension; and
• encouraging unapproved uses—such as through continuing education campaigns, talks by physicians, and ghostwritten articles.
To counter the “inverse benefit,” Dr Brody and his coauthor, David Light of the University of Medicine and Dentistry of New Jersey, suggest that writing treatment guidelines should be restricted to groups free of commercial interest. A neutral agency such as a branch of the National Institutes of Health or the Agency for Healthcare Research and Quality should conduct drug trials and comparative effectiveness research.
Creation of “new diseases” could be lessened by restricting drug companies’ input in clinical guidelines. Marketing by drug company sales people would be reduced if most US doctors didn’t see them—but now 94% of US doctors do.
Notes
Cite this as: BMJ 2011;342:d598
via bmj.com
Saturday, February 26, 2011
J&J Must Defend U.S. Kickback Lawsuit Claims, Judge Rules - Bloomberg
Johnson & Johnson must defend a lawsuit by the U.S. Justice Department claiming the company paid kickbacks to influence sales of its antipsychotic drug Risperdal to nursing home patients, a judge ruled today.
J&J asked the judge to dismiss the complaint, arguing that payments it made to Omnicare Inc., the largest U.S. pharmacy for nursing home patients, were allowable rebates and not illegal kickbacks. U.S. District Judge Richard Stearns ruled in federal court in Boston that the case may proceed against J&J, the world’s largest maker of health-care products.
The Justice Department joined complaints by whistleblowers Bernard Lisitza and David Kammerer, who sued under the False Claims Act. Stearns dismissed claims by Kammerer, as well as several U.S. states that sought to join the case. Lisitza, a former Omnicare pharmacist, first sued in 2003.
“This decision is a huge victory against corporate influence over taxpayer-funded health care,” said attorney Michael Behn, who represents Lisitza.
Carol Goodrich, a spokeswoman for New Brunswick, New Jersey-based J&J, said in an e-mail, “We will defend the case in court.”
The judge dismissed claims by Nevada, Texas and Illinois, while allowing those by Kentucky, Indiana and Virginia to proceed.
Millions of Dollars
The U.S. sued J&J and two units in January 2010, claiming they paid millions of dollars to induce Omnicare to buy and recommend J&J drugs including its antipsychotic Risperdal. J&J said in court papers that it didn’t violate the False Claims Act or Anti-Kickback Statute, as the government claims.
“This case is a remarkable attempt to attack common discounting arrangements that are expressly protected under federal and state law,” J&J’s lawyers wrote in a 53-page memorandum filed in court last June.
Two industry groups, the Pharmaceutical Research Manufacturers of America and the Biotechnology Industry Organization, had filed a friend-of-the court brief supporting J&J in the case.
Omnicare, based in Covington, Kentucky, agreed in November 2009 to pay $98 million to settle civil claims by the U.S. and several states that it took kickbacks from J&J. Omnicare didn’t admit liability in settling the case.
‘Masked’ Rebates
The government claims that J&J paid Omnicare millions of dollars of kickbacks, much in the form of interest-free loans. It claims that J&J also masked rebates as grants, educational funding, or meeting sponsorship fees. Those fees covered the cost of junkets by Omnicare managers to the Amelia Island Resort in Florida, according to the government.
J&J argued it engaged in common commercial practices such as giving customers higher rebates based on the “share” of a manufacturer’s product used and trying to get its drugs on formularies, which are lists of medications that an insurer, public health-care program or other payer will reimburse.
“Today, rebates remain standard industry practice and are absolutely essential to our health care system,” J&J lawyers wrote in court papers last June.
The case is U.S. ex re. Lisitza and Kammerer v. Johnson & Johnson, 07-10288, 05-11518, U.S. District Court, District of Massachusetts (Boston).
To contact the reporters on this story: David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.
To contact the editor responsible for this story: John Pickering at jpickering@bloomberg.net.
via bloomberg.com
1 Boring Old Man » selling seroquel V: driving the brand…
The original claim – weight neutral – was never true and they knew it wasn’t true, something that has ended up costing AstraZeneca $868 M plus legal fees so far [$520 M FDA-Fines + $198 M + $150 M]. The standard complaint is that they are getting off cheap, just a drop in the bucket compared to their profit margin – as if higher fines would deter such corporate behavior. Others feel that these things will continue until the actual executives involved in the deception are directly convicted of criminal behavior. But for the moment, AstraZeneca‘s Seroquel stands before us as the paradigm for how to play this game and win.
"It's cheaper for Big Pharma to cheat!"
National Institute for Health and Clinical Excellence (NICE) reforms
Tucked away in the Health and Social Care Bill on the government’s proposals to transfer the role of commissioning patient services from primary care trusts to GP-led consortia, are plans to reform the National Institute for Health and Clinical Excellence (NICE).
NICE, currently a special health authority will be re-established as a statutory non-departmental public body corporate. To reflect the broadening of NICE’s remit to provide guidance for the social care sector, the body’s name will change to the National Institute for Health and Care Excellence, although still called NICE.
In exercising its functions in an effective, efficient and economical fashion, NICE must continue to have regard to:
The broad cost-benefit balance in the provision of health or social care services in England
The degree of need individuals have for such services
The desirability of promoting innovation in the provision of health services and social care.
The NHS will eventually commission NICE to develop quality standards (statements defining high quality, cost effective care for a particular condition) for NHS care, and public health and social care. NICE will have a duty to establish a process for the preparation of quality standards on all NHS hospitals and clinics. The quality standards will have statutory status.
NICE will be able to give advice or guidance, provide information or make recommendations on matters relating to the provision of NHS services, public health services or social care. This may include guidance on new and existing medicines, treatments and procedures, and treating and caring for people with specific diseases and conditions or with particular social care needs. It may also enable NICE to publish or disseminate advice, guidance, information or recommendations to the NHS, local authorities or other organisations in the public, private, voluntary or community sectors on how to improve people's health and prevent illness and disease.
Regulations may be made requiring specified public bodies to have regard to NICE advice, guidance, information or recommendations or to comply with NICE’s recommendations.
Put simply, NICE will move from a body that rations drugs, to controller of NHS quality on everything.
NICE is important to private medical insurers as some only pay for drugs and treatment approved by NICE.
Private medical insurance news: 24 February 2011
Medtronic Bypasses a Hospital Group Buyer - Duff Wilson, NYTimes.com
Medtronic could save more than $40 million a year through its decision to cancel five group-purchasing contracts worth $2 billion and to negotiate prices directly with hospitals instead, Bernstein Research said in an investor note on Friday.
Whether the hospitals are happy with the move remains to be seen. Novation, the spurned middleman that held the contracts, is certainly unhappy.
Sixteen large hospitals have written Medtronic to express “extreme disappointment,” the group purchasing organization Novation said in a statement Thursday announcing the cancellations. Novation said thousands of hospitals could end up paying higher prices, and would struggle to compare medical devices because of Medtronic pricing confidentiality clauses.
“This move will likely raise costs for member organizations by eliminating the price protection that members benefit from through Novation’s national agreements,” Pete Allen, senior vice president of sourcing operations at Novation, said in a statement.
The hospitals’ letter, dated Feb. 16 and released by Novation on Friday, added, “Neither the health care community nor the country as a whole can afford the type of disruption and increased cost that your decision will have on our facilities.”
AstraZeneca ordered to pay damages over side effects of Iressa drug › Japan Today: Japan News and Discussion
AstraZeneca ordered to pay damages over side effects of Iressa drug › Japan Today: Japan News and Discussion: "OSAKA —
The Osaka District Court on Friday ordered the Japan unit of British drugmaker AstraZeneca PLC to pay a total of 60.5 million yen to nine out of 11 plaintiffs who demanded compensation over side effects caused by the lung cancer drug Iressa.
The three-judge panel, however, turned down the plaintiffs’ demand that the Japanese government pay the damages jointly with Osaka-based AstraZeneca KK, which is 80% owned by its British parent and the remaining 20% by Sumitomo Chemical Co.
The 11 plaintiffs had sought a total of 104.5 million yen in damages from the government and AstraZeneca.
In Friday’s decision, Presiding Judge Fumikiyo Takahashi said AstraZeneca failed to include sufficient explanations in the package insert about the side effects of the Iressa drug at the time of its approval.
The court acknowledged the drugmaker’s liability to compensate patients who took the drug through Oct 15, 2002, when it issued an urgent safety advisory urging medical institutions to tell patients about the risks from the drug’s side effects.
Japan was the first country to import the Iressa drug, which was developed by AstraZeneca, allowing it to put the drug on the Japanese market in July 2002.
On Friday’s ruling, Health, Labor and Welfare Minister Ritsuo Hosokawa issued a statement welcoming the court decision, saying he believes the government’s arguments were accepted.
Hosokawa also said the government will speed up studies on a relief scheme for sufferers of side effects caused by anticancer drugs.
- Sent using Google Toolbar"
The Osaka District Court on Friday ordered the Japan unit of British drugmaker AstraZeneca PLC to pay a total of 60.5 million yen to nine out of 11 plaintiffs who demanded compensation over side effects caused by the lung cancer drug Iressa.
The three-judge panel, however, turned down the plaintiffs’ demand that the Japanese government pay the damages jointly with Osaka-based AstraZeneca KK, which is 80% owned by its British parent and the remaining 20% by Sumitomo Chemical Co.
The 11 plaintiffs had sought a total of 104.5 million yen in damages from the government and AstraZeneca.
In Friday’s decision, Presiding Judge Fumikiyo Takahashi said AstraZeneca failed to include sufficient explanations in the package insert about the side effects of the Iressa drug at the time of its approval.
The court acknowledged the drugmaker’s liability to compensate patients who took the drug through Oct 15, 2002, when it issued an urgent safety advisory urging medical institutions to tell patients about the risks from the drug’s side effects.
Japan was the first country to import the Iressa drug, which was developed by AstraZeneca, allowing it to put the drug on the Japanese market in July 2002.
On Friday’s ruling, Health, Labor and Welfare Minister Ritsuo Hosokawa issued a statement welcoming the court decision, saying he believes the government’s arguments were accepted.
Hosokawa also said the government will speed up studies on a relief scheme for sufferers of side effects caused by anticancer drugs.
- Sent using Google Toolbar"
Friday, February 25, 2011
Lilly’s Neuroscience Research Chief Resigns - Health Blog - WSJ
By Jonathan D. Rockoff
The head of Eli Lilly’s research into Alzheimer’s disease, schizophrenia and other neurological diseases is unexpectedly leaving the company.
David Bredt’s last day at the drug maker is Feb. 25, a company spokeswoman says. He had joined Lilly in 2004.
Fellow industry drug researchers expressed surprise at the news, especially since Bredt had given no indication of his plans at recent events.
His departure comes after Lilly experienced a number of setbacks in its Alzheimer’s research, in particular. Most notably, the company halted development of an experimental Alzheimer’s drug called semagacestat last August, after studies showed it was worsening patients’ conditions.
via blogs.wsj.com
J&J CEO Weldon's 2010 performance bonus cut | Reuters
NEW YORK, Feb 25 (Reuters) - Johnson & Johnson (JNJ.N) cut the 2010 performance bonus of its chief executive, William Weldon, by 45 percent from 2009 levels to $1.98 million, according to a regulatory filing.
The CEO's diminished bonus comes after a year in which the giant diversified healthcare company endured a seemingly endless stream of recalls of consumer health products, medical devices and other products that hit the company's bottom line.
via reuters.com
Worth every penny! J&J Will Pay CEO $1.9 Million Salary
WASHINGTON (AP) -- Health care giant Johnson & Johnson raised Chief Executive William Weldon's salary but cut his annual bonus for 2010, after two years of revenue declines and an unprecedented string of recalls involving Tylenol and other household medicines.The New Brunswick, N.J.-based company set Weldon's salary at $1.92 million effective Jan 1, up 3 percent from $1.86 million in the previous year. The company disclosed the pay raise Friday in a Securities & Exchange Commission filing.
Placebo Journal Blog: Medical Humor With A Purpose: $166.50 by Stella Fitzgibbons MD
What is the significance of $166.50? It's the monthly cost of the least expensive of the prescription meds advertised on TV lately. What really steams me is that virtually all of them can be replaced by an older drug available for $4 a month at Walmart. Let's hear it for marketing. I wonder how patients feel when they find out they are spending 41 times as much as they need to.
Is Big Pharma Strangling Biotech Startups in Their Cradles? - The Atlantic
Bad Faith Negotiations: Kinsella says Big Pharma companies are routinely walking away from buyout deals that have been fully negotiated. Kinsella says his first brush with Big Pharma's new imperious ethos came in 2005. "We had a fully negotiated deal with [a major Pharma] to acquire a company. But because of their CEO's travel schedule, the deal didn't get signed before the Christmas holiday. When the CEO came back, he had changed his mind. This was a signature-ready buyout that took at least six months to negotiate. And [the company] just walked away. No explanation." Since then, Kinsella says, "There have been numerous instances of pharma companies walking away from deals that were fully negotiated. So this behavior is not a blip; it's been going on for over five years."
via theatlantic.com
Florida raids target sellers of pain pills - USATODAY.com
Oxycodone epicenter
Florida medical practitioners purchased more oxycodone pills in the first six months of 2010 than did health care practitioners in all other states combined.
California: 302,873
Maryland: 485,542
Georgia: 754,124
Ohio: 1 million
Florida: 41.3 million
Source: Drug Enforcement Administration
via usatoday.com
Of the top 25 oxycodone prescribers nationwide in 2008, 18 were in Broward County and three others were in neighboring Palm Beach County, says Detective Sgt. Richard Pisanti of the Broward County Sheriff's Office.
"We've become the honey hole of drugs," he says.
ProStrakan takeover doubt after Norgine raises stake - Herald Scotland
DUTCH drug group Norgine yesterday revealed that it had raised its stake in ProStrakan, potentially throwing a spanner into the works of Kyowa Hakko Kirin’s £292 million takeover plans for the Borders-based speciality pharmaceutical company.
Shares in ProStrakan yesterday closed marginally down at 132.75p, but still above the 130p-a-share bid agreed with the Japanese drugmaker earlier in the week, largely on the prospect that Norgine could yet gatecrash the deal and come back with a higher bid.
In mid-November, ProStrakan rebuffed an offer from Norgine, which snapped up a 13.75% stake but whose bid was said to undervalue the company.
The Dutch group yesterday revealed that it has now taken its stake to 14.4%.
However, Tokyo-based Kyowa Hakko Kirin already has irrevocable undertakings to accept its offer from shareholders representing 47.71% of ProStrakan’s equity, including Warburg Pincus, Aberforth, Schroders and LMS Capital.
A competing bid is likely to have to be pitched at 140p or above to override their irrevocable backing.
Kyowa Hakko Kirin’s offer was also unanimously supported by ProStrakan’s board.
The Japanese company, a unit of Japanese beer giant Kirin Holdings that focuses on oncology and urology, earlier this week said the acquisition of ProStrakan was aimed at expanding its cancer drug business outside Japan.
The Scottish company, which employs around 70 of its 300 staff in Scotland, has a number of drugs in key global markets including Sancuso, a novel skin patch for the prevention of chemotherapy-induced nausea and vomiting, and cancer pain treatment Abstral.
Thursday, February 24, 2011
Former Employee Accuses J&J, Other Companies Of Pricing Fraud - FoxBusiness.com
A former Johnson & Johnson (JNJ: 60.17, -0.25, -0.41%) employee has accused the health-care giant in a lawsuit of defrauding government health programs by improperly reporting drug-pricing information.
The lawsuit was originally filed confidentially in 2005 in federal court in Philadelphia, under U.S. laws designed to encourage would-be whistleblowers to bring information to government investigators about alleged health-care fraud. The Justice Department has declined to intervene in the case so far, according to court records.
The suit was unsealed in December, and another defendant in the case, pharmacy-service provider Omnicare Inc. (OCR: 27.59, +1.73, +6.69%), disclosed the suit in a regulatory filing Thursday. The lawsuit also names wholesale drug distributor McKesson Corp. (MCK: 78.22, -0.28, -0.36%) as a defendant.
The case was filed by Scott Bartz, who worked for J&J from 1999 until 2007, according to his lawsuit. His roles included working as a sales-compensation manager, in which he calculated product sales for use in determining bonuses for sales representatives.
J&J, of New Brunswick, N.J. and other drug makers who want their products paid for by the Medicaid health plan for the poor are required to offer Medicaid similar prices to the best prices available to private purchasers.
via foxbusiness.com
In an amended version of his lawsuit filed in 2007, Bartz alleged that J&J concealed from Medicaid discounts on drugs including antipsychotic Risperdal Consta and Razadyne treatment for Alzheimer's disease that were offered to other purchasers, and that McKesson and Omnicare assisted these efforts. The suit alleges these actions violated the federal False Claims Act.
Bartz also alleged in the lawsuit that J&J inflated its earnings by engaging in "channel stuffing," or selling large amounts of drugs to distributors ahead of end-buyer demand.
Bartz also alleges that J&J retaliated against him for voicing his concerns about these efforts, including a demotion before his employment was terminated in 2007.
Bartz has since filed another amended version of the lawsuit, but it's under seal by court order. An attorney for Bartz couldn't immediately be reached. A J&J spokeswoman said the company will defend the case in court.
Omnicare said in its regulatory filing the allegations are without merit, and it intends to defend itself. A spokesman declined to comment further. A spokeswoman for McKesson declined to comment immediately.
Court records indicate the case has been transferred to federal court in Boston at the defendants' request. That is the same venue where other whistleblower cases involving J&J are pending. Last year, the Justice Department intervened in two whistleblower cases and accused J&J of paying millions of dollars of kickbacks to Omnicare to encourage use of J&J drugs, including Risperdal. J&J has said it believes its conduct was lawful and appropriate.
In 2009, Omnicare agreed to pay $98 million to settle government allegations that it participated in kickback schemes along with drug makers including J&J.
Read more: http://www.foxbusiness.com/industries/2011/02/24/employee-accuses-jj-companie...
When Prescribing Less May Improve Outcomes - ABC News Part 1
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With a few exceptions, when physicians talk, they recommend. Take this. Try that. They satisfy the expectation that automatically comes with a patient's visit or phone call. The physician is compelled to make a recommendation -- a pill, a device or a procedure. Both the physician and medical supplier financially benefit. But is your doctor's advice always in your best interest?
Not always.
In a 2000 JAMA publication, Julie Magno Zito of the University of Maryland and her coauthors stated that there had been an explosion in psychotropic prescriptions for pre-schoolers without adequate safety and long-term studies and generally without FDA approvals.
Dr. Joseph Coyle of Harvard Medical School editorialized on this "troubling change in practice."
Likewise, in a 2001 JAMA article, Dr. Chunliu Zhan of the Agency for Healthcare Research and Quality and his colleagues found that American elderly patients are often overly and inappropriately medicated.
And, there are medical errors. Reports from the Institute of Medicine and HealthGrades indicate that there have been 400,000 to 1.2 million error-induced deaths in the United States from 1996 to 2006.
Excessive medications and procedures, adverse events and medical errors are endemic to medicine. In the early 1990s, surgeons were encouraged to perform quadruple bypass surgery for heart disease. Recent studies now suggest the surgery was, in many cases, a waste of time and money, improving neither morbidity nor mortality.
Surgeons are not the only medical professionals who misdiagnose and perform unnecessary procedures. In fact, no one in the medical industry is a bigger offender when it comes to mistreatment than those of us in psychiatry.
With psychoactive diagnoses and medications, I'm currently seeing a trend among doctors prescribing adolescents with stimulants for bogus reports of ADD. In the most common occurrence, the doctor misses the diagnoses of daily marijuana abuse, alcohol abuse and oxycodone abuse.
Many doctors fail to perform a simple urine drug screen, treating instead the residual drug-related symptoms of inattention, lack of motivation, poor academic performance and forgetfulness with amphetamines, antidepressants or antipsychotics.
At worst, kids receive all three medications together, which is dangerous in immeasurable ways. This also happens to adults.
via abcnews.go.com
When Prescribing Less May Improve Outcomes - ABC News
When 'Medicine' Makes Things Worse
In the past, psychiatric physicians have diagnosed homosexuality, paraphrenia, paranoia, narcissism, neuroses, combat fatigue and other entities, treating those "disorders" with a variety of therapies, including pills.When 'Medicine' Makes Things Worse
More recently, psychiatrists diagnose bipolar disorder not otherwise specified (NOS), adult attention deficit disorder and pre-psychotic conditions, for which they may prescribe pills. The problem is that some of those earlier diagnoses like (homosexuality, neuroses, combat fatigue, paranoia and paraphrenia) no longer exist as entities recognized by the DSM-IV-TR -- the most current compendium of mental conditions and disorders.
Virtually anyone at any given time can meet the criteria for bipolar disorder NOS or ADD. Anyone. And the problem is everyone diagnosed with even one of these illnesses triggers the pill dispenser. It's also OK to offer the patient a metaphorical motivational kick and advise them to just do something to help themselves. That may do more to improve outcomes and reduce adverse events and unnecessary prescribing than an injudiciously prescribed pill or procedure.
Dr. Stefan Kruszewski is an Addiction Psychiatrist and CEO of Kruszewski & Associates, a Harrisburg, Pennsylvania based firm specializing in illuminating healthcare and financial fraud.
via abcnews.go.com
New hypothesis explains why Vioxx, Bextra, and Avandia increase risk of heart attacks and strokes
Check out this website I found at eurekalert.org
If the FDA had been aware of the increased cardiovascular risk that arises from drugs that cause fluid retention, Vioxx, Bextra, and Avandia might never have been approved. These findings might spur the FDA to alter some of its current policies," he continues. "The calculations in this paper might also help pharmaceutical manufacturers screen drugs for their cardiovascular risk at an early stage in the drug development process.
Wednesday, February 23, 2011
Courageous FDA Whistleblower Jerome Bressler Died | Scoop News
Courageous FDA Whistleblower Jerome Bressler Died
Thursday, 24 February 2011, 10:15 am
Press Release: Mission Possible InternationalCourageous FDA Whistleblower Jerome Bressler Died
He passed away on January 26 and was buried on January 31st with full military honors, a veteran of WWII
There was another war Jerome fought that still drags on. He battled to prevent approval of the deadly addictive excitoneurotoxic, genetically engineered, carcinogenic drug aspartame. (NutraSweet/AminoSweet/Spoonful/Naturtaste/Canderel/E951 among other aliases). This chemical was developed by the troubled G. D. Searle Co., which was swamped by lawsuits from women injured by its intrauterine device. Broke Searle hired Don Rumsfeld to fix the problem and get aspartame on the market to bring in some cash. Honest FDA Commissioner Jeri Goyan refused FDA approval because of its toxicity and was about to sign the order banning aspartame. Rumsfeld had the political clout, was on Ronald Regan’s transition team, so the night after Reagan was inaugurated Goyan was fired and a new bought-and-paid-for- Commissioner, Arthur Hull Hayes, could take over. Reagan wrote an executive order making FDA powerless to do anything on aspartame, to keep Dr. Goyan from signing the revoked petition into law. Linda Hart who became Mrs. Goyan, was with him when the 3:00 AM termination call from the Reagan team came in according to her letter to me.. http://www.rense.com/general79/aspar.htm Hayes overruled the Board of Inquiry Report and approved aspartame. http://www.mpwhi.com/fda_petition1.doc He then took a ten year consultant contract with NutraSweet PR outfit.
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Approved by politics because it never could be approved by science G. D. Searle had survived the FDA’s demand for indictment. Their defense team hired US Prosecutors, Sam Skinner and William Conlon. When the district attorney hires on with the godfather expect acquittal. She the whole story in the aspartame documentary Sweet Misery: A Poisoned World. http://www.soundandfury.tv/pages/rumsfeld.html
Jerome Bressler belonged to the old FDA who tried so hard to keep the chemical poison aspartame off the market. When Jerome retired from FDA I called to thank him for the Bressler Report. He let me know immediately that the worst 20%, two mice studies, had been removed by FDA. He was very disturbed that the FDA had deleted these studies and told me the public had the right to know. He asked me to find them, because they were so important. It was obvious from his conversation how worried he was that the public is consuming this poison, and had no idea what these studies had shown. The new FDA today, since Hayes had taken over, tells the public its safe and hides and seals important documents that would warn us aspartame is deadly. Jerome told me how hard it was to live with the fact that the public was consuming a poison and had no way to get the truth. For this reason I notified Dr. H. J. Roberts and Dr. Russell Blaylock so they would know as well, and they called and verified. Dr. Roberts tried to get these missing documents through his senator but FDA refused to release them.
That was about 8 years ago. Mr. Bressler lived in Chicago and Lane Shore, Mission Possible Chicago contacted him. They had many conversations and became friends. Lane felt like Jerome did that it was vital to get all the data because of epidemics of this poison, especially since in his own family he had lost 8 from aspartame. One relative used aspartame during pregnancy, had twins and one died. The other was hanging on to life at the time of birth but did survive. Lane said the one thing Jerome told him that stood out was that he told his family and close friends not to touch this stuff, but there was no way to warn the public. Jerome also spoke of times when he was denied access to certain material. He became angry and threatened to get a court order.
In Chicago Lane and I went to see Jerome. Over and over again Jerome said you have to get those studies. Lane had with him the Bressler Report and Jerome said, “is Collins name on the report?” When Lane said no, he said, “then you don’t have a complete report! Dr. Thomas F. X. Collins was a lead scientist and his name had been stricken evidently so he couldn’t be contacted. I know that Lane called Dr. Collins and spoke to his wife but she said there was no way he would speak out.
Lane asked Jerome to help get aspartame off the market, saying, “It started in Illinois and it should end in Illinois!” Jerome agreed and said the best way was to get an investigation by the Chicago Tribune. I mentioned this to a friend. Jack Samuels, who told me to call Monica Eng, a reporter with the Tribune who had done an excellent article on MSG.
The next time I was in Chicago it was for a health expo and Lane and I went to see Jerome again. While Jerome said again the Chicago Tribune should do the investigation he didn’t want to be interviewed. Monica Eng said for her paper to do an investigation she had to have an interview. . He wanted the Chicago Tribune to do an investigation but didn’t want to be interviewed. Jerome had not been interviewed for years and told us with some humor about the time one media representative had left an apple pie at the front door with a note saying all they wanted to do was ask some questions. Dr. Russell Blaylock was speaking at the expo and Monica Eng came to hear him. I had asked Dr. Blaylock if he would call on Jerome and he said he would just as soon as he could make time while he was there. We were hopeful that Dr. Blaylock could get Jerome to agree to the interview. As it turned out, Monica suggested that we go see him that night and we did. A friend, Diane Murphy , Mission Possible Illinois, also went with us.
Of interest is that Jerome told us it was Dr. Adrian Gross, scientist and toxicologist, with the FDA who decided to put his name on the report saying, ‘”Here’s your claim to fame.” Indeed, Dr. Gross was right. The 76 page report remains a key document against aspartame and was the culmination of a priority investigation of G. D. Searle’s laboratory in Skokie, Illinois. Barbara Mullarkey, a reporter and health activist, said it compared all the available raw and summary data of a 115 week oral tumorgenicity rat study, against the manufacturer’s FDA submission. Barbara said that before the Bressler Report was handed over to her the FDA blanked out some of the attached charts and memos, as if they were some sort of state secrets. I remember when Dave Rietz and I started his web site, www.dorway.com and added this report. He said there was definitely something missing and it must be very important. Dave in the end lost his life to aspartame.Monica Eng taped about a two hour conversation with Jerome. He changed his mind about an interview after he met her. She has a very professional manner, very charming and attractive. It was obvious he was enjoying the visit and actually smiling from his bed. He began to reminisce about the years of battling Searle. At the end Monica asked if she could come back again as his friend and he agreed.
While the Editors at the Chicago Tribune had promised Monica she could do the investigation if she got an interview they changed their mind. They said they would start the investigation when we could obtain the two studies Bressler mentioned. It was a slick way of getting out of doing the story. Then a strange thing happened. Lane received a call from a man saying he worked for the Tribune. He appeared hostile and said to Lane, “I don’t even think you know Jerome Bressler!” When I told Monica about the call she said it was odd since nobody knew about this but her.
Lane worked tirelessly looking for the studies. Finally Dr. Madelon Price, a biochemist, who worked with Dr. John Olney until her retirement found them. The studies were teratology and showed aspartame causes birth defects. In another document that was missing from the records recently received indeed there was this statement.. http://www.mpwhi.com/thomas_f_x_collins_file.pdf So the FDA has known for 30 years that aspartame causes birth defects and have covered it up.
“The European Environmental Association has projected that with the rise of autism caused by toxic foods like Aspartame, MSG, Fluoride, and environmental degradation, by 2013 no one will be born in the Western World that does not to some degree have autism. Our board of AAEM, American Academy of Environmental Medicine and Dr. William Rae, director of the Dallas Environmental Clinic agreed in open discussion at the October 2010 annual meeting." This was quoted by Bill Deagle, M.D.. This could have been avoided if the FDA had done their job and warned the public, and taken it off the market. Think of all these children all over the world with birth defects that could have been avoided. Aspartame is also an abortifacient so think of the hundreds of thousands or more that have been lost. According to Dr. James Bowen this is genocide and comes under Title 18 of the domestic genocide code: http://www.rense.com/general/asp.htm Dr. John Olney in his report to the Board of Inquiry let the FDA know that birth defects are a given and in combination with MSG could harm the brains of the unborn even more. http://www.wnho.net/dr_olney1.doc In fact, FDA had told Dr. Olney babies and children would never get aspartame. Again, this was the old FDA. Today anything goes.
Recently in a Paris meeting, Dr. Morando Soffritti discussed his last study showing aspartame causes liver and lung cancer, and his others showing aspartame is a multipotential carcinogen causing everything from leukemia and lymphoma to kidney cancer. He said that at least aspartame should be removed from children’s drugs. Nobody seems to care and many of the SIDS deaths could be aspartame related.
Lane Shore was very happy the day he handed over the missing studies to Monica Eng of the Chicago Tribune. Finally an investigation from the beginning was going to be done as Jerome Bressler had asked. We were shocked when the editors flipped again and said the story could not be done. This time they agreed when a new study was done they would publish. When Dr. Soffritti published his last study on aspartame and liver and lung cancer they backed down again. . http://www.mpwhi.com/new_study_shows_aspartame_causes_cancer.htm
What is the relationship of this newspaper with the aspartame producers? The public has the right to know but not if a big time corporate poison is killing them!.Through the tireless efforts of Lane Shore we have received abundant more damning records. It was a happy day for Lane Shore to hand over to Jerome Bressler his report with the missing studies, and Dr. Thomas Collins’ name restored. Lane and Jerome talked often and Lane constantly went to see him. He probably would have died 6 months ago if it hadn’t been for Lane. He walked in and found Jerome gasping for breath because the respiratory tube had fallen out. and got the nurse just in time.
I’m happy that at least before Jerome died that he received his report in full. For those who haven’t seen it:. http://www.mpwhi.com/fda_hid_research_that_damned_aspartame.htm
Aspartame causing birth defects and cancer has been known from the beginning. As soon as aspartame got on the market so many complaints came into FDA they started referring them to the AIDS Hotline. Senator Howard Metzenbaum was able to get congressional hearings in 1985. Dr. Adrian Gross, FDA toxicologist and scientist testified that aspartame violated the Delaney Amendment because of the brain tumors and brain cancer, and that FDA should not have been able to even set an ADI, allowable daily intake. His last words will never be forgotten, “If the FDA violates its own laws who is left to protect the public.” FDA toxicologist, Dr. Jacqueline Verrett testified in 1987 that even then aspartame had not been proven safe. It had been on the market 6 years with complaints pouring into the FDA. She said that all studies were built on a foundation of sand and should be thrown out. Her testimony and Dr. Gross’ testimony can be found on www.mpwhi.com
Ten years ago H. J. Roberts, M.D. wrote the 1000 page medical text with hundreds of case histories on the plague, “Aspartame Disease: An Ignored Epidemic”: www.sunsentpress.com Many call Aspartame Disease Rumsfeld Plague for when Rumsfeld “ called in his markers” to get it on the market he knew he was condemning the population to disability and death. Russell Blaylock, M.D. wrote about aspartame in Excitotoxins: The Taste That Kills, www.russellblaylockmd.com In 1996 60 Minutes did an expose when Dr. Olney made world news on the aspartame and brain tumor issue. At that time Dr. Ralph Walton did research on aspartame and funding and showed that 92% of independent studies shows the problems aspartame causes, and he said if you eliminate 6 studies the FDA had something to do with and one pro-aspartame summary 100 % of independent studies shows the problems. Searle couldn’t get the studies to show safety before approval and the aspartame industry can’t do it now as independent study after independent study+ continues to show the problems that are causing disability and death to the population. Only studies funded or controlled by industry ever said it was safe, and these are not acceptable. History shows the cover-up.
The word is out now so Ajinomoto has changed the name of aspartame to AminoSweet. Be warned. They are also trying to get Advantame approved, another aspartame product. Will the FDA do it to us again? Probably. Already a more potent form of aspartame called Neotame has been approved. No longer can anyone eat processed food with safety, with aspartame many times hidden in artificial and natural flavors. Stuart Pape from the National Yogurt Association has petitioned the FDA to allow aspartame in yogurt and dairy products without labeling. The FDA has yet to respond on whether this was allowed.
The world should honor Jerome Bressler; a modest man who said credit should be given to the lead scientist, Dr. Collins. He said it was a team effort, not just his. He did not seek praise or fame, but wanted the FDA to do its job and remove a poison from the market and save the people.. Even in a nursing home he tried to stop people from using it. It bothered him for three decades and it’s hoped that in his memory mainstream media will finally come forth and warn the public, and tell corporations enough is enough.
ENDS
via scoop.co.nz
"Dramatic changes" set for Australian pharma
The Australian pharmaceutical industry landscape is set to change dramatically as a result of government changes to the Pharmaceutical Benefits Scheme (PBS), says a new report.
Following Parliamentary approval last November of the National Health Amendment (Pharmaceutical Benefits Scheme) Bill of 2010, which aims to make savings of around A$1.9 billion over five years, the outlook for the future includes withdrawn products, a struggling generics industry and reorganisation within the wholesaling sector, warns the study, from Datamonitor.
via pharmatimes.com
Avastin - Roche's `Brilliant Concept' Fades Amid Doctor Disappointment - Bloomberg
The cancer drug Avastin, introduced in 2004, has largely lived up to its billing as an innovative way to attack cancer, along the way generating the most revenue for any cancer drug while being Roche Holding AG’s best-selling product with 6.46 billion Swiss francs ($6.88 billion) in sales last year.
Only now are Avastin’s limitations becoming clear to doctors. Even before U.S. regulators in December moved to revoke the drug’s conditional approval for treating breast cancer, Kent Osborne, a Texas oncologist, said in an interview that he was reducing use of the drug, citing its “huge” costs, disappointing benefits and frequent side effects.
“We’re talking about breast cancer that has spread and our job here, since we can’t cure patients yet, is to palliate them,” said Osborne, director of Baylor College of Medicine’s cancer center in Houston. “If you have a drug that makes their quality of life worse, you haven’t accomplished that goal.”
via bloomberg.com
Introducing Wendell Potter
Since I walked away as head of communications at a top health insurance company in May of 2008, I've worked tirelessly as an outspoken critic of corporate PR and the distortion and fear manufactured by America’s health insurance industry. It is a PR juggernaut that is bankrolled by millions of dollars, rivaling lobbying budgets and underwriting many "non-partisan" and "grassroots" organizations.
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