NICE garners new fans–and new critics
The U.K.'s National Institute for Health and Clinical Excellence may be the healthcare business's favorite love-to-hate-it institution. The agency analyzes drugs and other treatments for their cost-effectiveness, and sometimes it makes decisions that patients find cold-blooded, to say the least.
And pharma often agrees, often for its own cold-blooded reasons: If NICE rules against a medication, then the National Health Service doesn't pay for it, and a huge potential market is lost. Not to mention the fact that other governments often watch NICE's decisions and tailor their own drug reimbursements accordingly.
As the U.S. looks to be mulling a version of this cost-effectiveness analysis, in an attempt to rein in wildly out-of-control healthcare costs, NICE is getting an entirely new group of critics. But it's also getting a fair number of admirers as well. Jim Edwards at BNet scoffs at all the hand-wringing over NICE's initial rejection of costly kidney cancer treatments, saying that the refusal actually did what it was supposed to: the makers of those treatments now are cutting their prices.
Meanwhile, the New York Times boils down NICE's role--and the role of any imitators--to one question: How much is life worth? That's not the sort of question Americans are accustomed to asking. So what do you think? Is NICE a cold-hearted bean counter? Or the sort of gatekeeper today's healthcare requires?
- read the post at BNet
- check out the WSJ Health Blog's take
- see the article in the NYT
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Roche stalls; Genentech soldiers on
A Genentech official tells the WSJ Health Blog that the company's morale hasn't been affected by the still-treading-water Roche buyout. Nor have employees begun to head for the doors. But In the Pipeline is skeptical, both of the supposed unchanged morale and of the eventual deal itself. Report | Report
Cleveland Clinic puts pharma payments online
The prestigious Cleveland Clinic says it's started airing business relationships that its 1,800 staff doctors and scientists have with drug and device makers. A database of payments of $5,000 and above will be maintained on the clinic's website as part of an overall revamp of its conflicts of interest policies, which has been underway for the past couple of years. With this new move, the Cleveland Clinic steps to the forefront of medical facilities' efforts to bring transparency to their relationships with industry.
The clinic didn't embark on the conflicts-of-interest overhaul completely voluntarily, the New York Times notes. Several years ago, several of its prominent doctors were criticized for their financial ties to the industry. Since then, the clinic has created ways to monitor those ties and established a committee to review any relationships that are considered "significant."
With this new step toward public disclosure, the clinic is right in tune with the times. As you know, disclosure has been a hot topic all year, with Congress investigating ties between doctors and researchers on one side and pharma on the other. At the same time, lawmakers have drafted legislation that would mandate disclosure of pharma and device companies' payments to doctors. And some drugmakers, such as Merck and Eli Lilly, have pledged to start disclosing those payments next year, with or without legislation.
- check out the clinic's release
- read the New York Times story
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Merck’s 2009 estimates disappoint Street
Analysts were disappointed with Merck's 2009 earnings estimates--and when analysts aren't happy, nobody's happy. The drugmaker's stock is already suffering on the news that it predicts revenue to fall off by about 3 percent and profits to drop 6 percent. That leaves earnings at $3.15 to $3.30 a share, excluding restructuring costs, which, given the company's layoff program, should be considerable. Analysts had expected earnings of $3.52 per share on 3 percent revenue growth.
The company is hanging onto its pledge of increasing shareholder value, saying its strong balance sheet will help prop up dividends at their current levels. Plus, the company says it will be able to repurchase some stock--to shore up the share price--and "take advantage of strategic opportunities," which we read to be "pipeline-boosting biotech deals."
- see the Merck release
- read the Wall Street Journal story
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Cigna cuts patients’ costs for Lipitor
Cigna is giving patients and Pfizer a break today. The insurance giant bumped Lipitor up to preferred status on its formulary, cutting copays at a time when the economy is slowing. That's likely to help patients stay on Lipitor, rather than switch to a cheaper generic to save money.
And it helps Pfizer, of course, because the drugmaker is trying to milk as much cash as it can out of the Lipitor franchise before the drug goes off patient in 2011. The more patients it can persuade to keep taking Lipitor--or to switch to the med, as it's been lobbying for--the more money it can reap from the cholesterol powerhouse.
As you know, Lipitor lost a big chunk of scrips when Merck's Zocor went generic and patients switched to that less expensive option. Pfizer has been running studies in an attempt to show Lipitor's superiority to alternative cholesterol meds, hoping to hang onto as many patients as it can. And no wonder: Lipitor brought in more than $12 billion in sales last year for Pfizer, more than a quarter of the company's overall revenues.
- read the Cigna release
- check out the story in the Star-Ledger
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Evotec Announces Three-Year Drug Discovery Collaboration
Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) today announced the start of a research collaboration with Novartis to identify and develop novel small molecule therapeutics. The collaboration will run for an initial period of three years. Evotec will apply its powerful drug discovery platform in combination with its extensive disease biology expertise to advance a drug discovery program against a target nominated by Novartis through discovery into the clinic.The Tom Daschle Appointment for HHS - What’s Inside?
Former Senate leader Tom Daschle has been tapped by President-Elect Barack Obama as the new Secretary of Health and Human Services. Here is some of the legislation Senator Dashcle either sponsored or co-sponsored related to FDA and to the pharmaceutical industry that provides some insight into positions. Perhaps most noteworthy is the FAIR Act:
- S.2328 - Pharmaceutical Market Access and Drug Safety Act of 2004 - A bill that would amend FDA to allow the importation of drugs. It would have required manufacturers to submit a statement that explained the differences between approved drugs for the US and a related drug from a foreign country. (co-sponsor)
- S.2486 - Fair Advertising and Increased Research Act (FAIR) - A bill that would limit the deduction for advertisting of FDA approved prescription drugs by the manufacturer of such drugs to the level of such manufacturer's research and development expenditures. (co-sponsor)
- S.1638 - Healthy Kids Act - A bill that would help parents keep their children from starting tobacco use and to stop the tobacco industry to stop targeting children and to reduce overall use of tobacco.
- S.1976 - National Cancer Act of 2002 - This bill was aimed to fund prevention and treatment programs of the NCI, including translational cancer research and addresses issues including clinical trial participation; workforce needs; Medicare coverage; protocols and guidelines; National Program of Comprehensive Cancer Control Plans; the supply of researchers; environmental risk factors research; and colorectal cancer screening demonstration program.
Drug Marketing Techniques May Be Risking Patient Safety, British Medical Journal
With new drugs being reviewed by regulatory agencies and then released onto the market faster than ever before, patients' safety is being compromised, warns a study published on bmj.com today.Cleveland Clinic Begins Public Disclosure Of Physician-Industry Relationships
Cleveland Clinic this week began publishing on its Web site complete disclosures of physicians' and researchers' business relationships and financial ties, the New York Times reports.Isis Announces That OGX-011 Has Shown Overall Survival Advantage In Prostate Cancer Compared To Standard Therapy In A Randomized Phase 2 Study
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that OncoGenex Pharmaceuticals, Inc. provided positive survival results from a randomized Phase 2 clinical trial of OGX-011 in combination with docetaxel and prednisone ("the OGX-011 arm") compared to docetaxel and prednisone alone ("the control arm") for first-line treatment of metastatic castrate resistant prostate cancer. The current 10.Bionovo Announces Development Plans For Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
Bionovo, Inc. (Nasdaq: BNVI) announced that the FDA has reviewed the company's manufacturing and control process descriptions (CMC), and has provided guidance on how Bionovo can move forward with the development of Menerba (formerly named MF101) for menopausal hot flashes. "We have concluded three CMC discussions with the FDA, and are moving to address the Agency's recommendations for further development of Menerba.The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 3
Here is the last of the 3-part series about the impact of expected upcoming changes in the policy environment and the tremendous migration in the communications environment and how this affects the marketing of pharmaceutical products. In this last installment, there is an examination of just a few of the many possibilities that are open to pharmaceutical involvement to migrate marketing into digital in anticipation of these expected challenges to traditional means of marketing, as Congress seeks to reign in DTC and monitor and even curtail the relationships that industry has with physicians and patients.‘Intelligent’ Materials To Revolutionise Surgical Implants - Nanotechnology Will Provide Superior Implants For Orthopaedic Patients
A brand new process that could revolutionise the reliability and durability of surgical implants, such as hip and knee replacements, has today, 2 December 08, received recognition for its medical and commercial potential by achieving one of the world's most sought after accolades.FDA: Pancreatic enzyme medically necessary
Pancreatic enzyme replacement products have been around for a long time, but have largely existed as nutritional supplements. Yesterday, an FDA official said the products are medically necessary, which might mean an approval is in store for Solvay's Creon. Creon and similar products aim to help patients with chronic pancreatitis, cystic fibrosis and other conditions that require replacement of pancreatic enzymes essential for digestion. Report
More suffering at Merck ahead
Merck has seen its share of ups and downs (mostly downs) over the last few years, but it seemed like things were finally turning around for the company--despite myriad lawsuits over (need we say it again?) Vioxx.
Under the guidance of Richard Clark (photo), however, the company had eight drugs approved in just two years, a feat that no doubt helped raise its standing in the eyes of investors. In efforts to weather the storm, Clark led a restructuring effort that resulted in thousands of job cuts.
Now Merck stock is down 50 percent compared to about a year ago and the stock has performed worse than that of any other major pharma company. Tomorrow, Clark will try to impress investors with some smooth moves, but he had better have a trick up his sleeve if he wants to impress Wall Street, writers at Forbes say. Wall Street investors won't settle for anything less than some remarkable research or news of a smart and strategic acquisition.
- read the Forbes story
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Antidepressants prescribed to children, babies
According to The Australian, almost 4,000 Australian children under the age of 10 received a prescription for antidepressant drugs in the last year, despite the fact that Australia has not approved the use of antidepressants in children or adolescents.
Of these, 553 of the children were under the age of five and 48 were babies. "At first pass, it is beyond comprehension that more than 500 Australian children--aged one to five years--have received an antidepressant drug," said Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder. He raised concerns about side effects and efficacy, and suggested having physicians justify the prescriptions.
The data came from the Pharmaceutical Benefits Schedule, which provides information on patients who receive subsidized medications. In fact, physicians prescribe most antidepressant medications privately.
Most of the drugs are not for children or adolescents less than the age of 18 years and it even says so on the label. However, some physicians ignore the label and prescribe the medications freely, either for intended or off-label uses. For example, physicians wrote 3,347 prescriptions for Wyeth's Effexor last year, which clearly says it is not for anyone less than 18 years of age. Eight of the prescription recipients were less than two years old.
- see the Pharmalot blog post
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Big Pharma: Not recession-proof
It is true that humans will need healthcare regardless of how short on cash they are, but David Brennan (photo), CEO of AstraZeneca, says that if you believed healthcare was recession proof, you are wrong.
While speaking at a Financial Times conference in London, he said the recession will be "deep and long," indeed affecting healthcare, including the pharmaceutical industry. That's likely no surprise to FiercePharma readers, who have witnessed a variety of layoffs, cutbacks and other restructuring efforts aimed at cost-cutting within the industry.
As a recap, in 2008, Merck cut 8,400 jobs, but we saw major cuts at Abbot, AstraZeneca, Schering-Plough, UCB Pharma, Wyeth and at many smaller drug companies as well. The industry is likely to see more layoffs as we enter 2009.
- more in the Wall Street Journal blog
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Roche exec: DTC ads hurt big pharma
We can blame the tarnished reputation of the pharmaceutical industry on its decision to participate in direct-to-consumer advertising according to William Burns, head of Roche's pharmaceuticals group.
Are TV ads a fair scapegoat for pharma's problems? We're not sure, but Burns' revelation is ironic since it is clear is that Roche has dropped a hefty pile of cash on having Sally Field (video) peddle its osteoporosis drug, Boniva, on television lately--and we're betting that Roche will won't stop commercial ads aimed at consumers.
Burns says that direct-to-consumer ads undermine pharma's reputation in the eyes of patients. "DTC advertising has been the worst decision for the drug industry," he said. "When industry says we're spending all the money on R&D, but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility."
Only New Zealand and the U.S. allow direct-to-consumer advertising, but its prevalence has skyrocketed in the U.S., increasing 330 percent between 1996 and 2005.
- read the Pharmalot blog post
- see the Wall Street Journal blog entry
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Are brand name heart drugs superior?
According to a new review of randomized controlled trials, editorials and commentaries published in today's issue of the Journal of the American Medical Association (JAMA), patients who spend extra cash on brand name heart meds do no better than patients who go the generic route. Interestingly, the reviewers found significant discrepancies between the randomized controlled trials and the editorials and commentaries published in the literature.
Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues looked at studies published between 1984 and August of 2008 and identified 47 data-driven articles and 43 editorials and commentaries.
The researchers looked at angiotensin converting enzyme (ACE) inhibitors, anti-platelet medications, alpha- and beta-blockers, calcium-channel blockers, diuretics, statins, narrow therapeutic index (NTI) anti-arrhythmic meds and warfarin, and found no evidence that expensive brand name heart medications are better than generic equivalents.
Of the 47 research articles, 81 percent were randomized controlled trials. The studies found clinical equivalence in 100 percent of studies looking at beta-blockers (seven trials), antiplatelet agents (three trials), statins (two trials), ACE inhibitors (one trial), alpha-blockers (one trial), and for the NTI drugs - class I anti-arrhythmics (one trial) and warfarin (one trial). They found clinical equivalence in 71 percent of calcium-channel blockers (five of seven trials) and in 91 percent of diuretics (10 of 11 trials).
According to the FDA, "A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use," but patients and clinicians alike have had doubts about their equivalency and safety.
In fact, the reviewers found 43 editorials and commentaries that met their criteria and over half of those expressed negativity about switching to generics from brand name products, less than 30 percent were positive about substituting with generics and the rest did not reach a conclusion on the topic. When it came to the NTI meds in particular, about two-thirds of the articles discouraged generic substitution and less than one-fourth supported making the switch.
The discrepancies between the randomized controlled trials and the editorials and commentaries could be due to the authors' personal experiences or due to undisclosed financial ties with the industry, which about half of the former--and none of the latter--disclosed.
- read the Washington Post story
- see more at WebMD
- find the LA Times blog post
- here's another blog entry at Pharmalot
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