Latest Drugwonks' Blog
These two articles demonstrate the importance of commercialization in addressing the clinical and logistical barriers to personalized medicine.
Medco, CVS Caremark Gear Up to Expand Genetic Testing Management Services
www.aishealth.com/Bnow/hbd060710.html
23andMe Partner to Provide Genetic Counseling
www.genomeweb.com//node/942414
This movement will be the counterweight to one size fits all comparative effectiveness...
Former Senate Democratic leader Tom Daschle and Victoria Kennedy, the late senator’s wife, are expected to be named co-chairs this week of a $125 million campaign White House allies are rolling out to defend health reform amid growing signs the party is failing to get political traction on the issue.
The extraordinary campaign, which could provide an unprecedented amount of cover for a White House in a policy debate, reflects urgency among Democrats to explain, defend and depoliticize health reform now that people are beginning to feel the new law's effects.
The Health Information Center is being started by Andrew Grossman, a veteran Democratic operative who founded Wal-Mart Watch, a labor-backed group to challenge the world’s largest retailer.
Even without issuing one press release, this "Health Information Center" misleads by ripping off the name of a "National Health Information Center" which is run by the federal government.
Here is the link to the site www.health.gov/nhic/. According to the site NHIC puts health professionals and consumers who have health questions in touch with those organizations that are best able to provide answers. NHIC was established in 1979 by the Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Office of the Secretary, U.S. Department of Health and Human Services.
NHIC also provides key support for the healthfinder.gov Web site, your gateway to reliable consumer health information.
And what does the new Health Information Center funded by cash raised by the Democrats claim to do:
The center’s rollout is part of a Democratic Party-wide effort to bolster support for health reform as the provisions begin kicking in.
Democrats and the White House will hold more than 100 simultaneous events nationwide as President Obama plunges back into health reform, selling the historic plan all over again as its provisions kick in. More than 10,000 people will be on the phone with the president as he holds a “national tele-town hall” meeting, 22 minutes from the White House at the Holiday Park Multipurpose Senior Center in Wheaton, Md.
This is, as noted above, an effort to "depoliticize" the implementation of the new health care law.
Which is why you want to call the propaganda effort THE HEALTH INFORMATION CENTER and not the Campaign to Neutralize Healthcare As An Issue In The Midterms Center
Calling it the Health Information Center reminds me of the restaurant Eddie Murphy worked at in "Coming to America" named McDowells. Cleo McDowell who runs the restaurant explains why McDonalds might have a problem with the name:
"Me and the McDonald's people got this little misunderstanding. See, they're McDonald's... I'm McDowell's. They got the Golden Arches, mine is the Golden Arcs. They got the Big Mac, I got the Big Mick. We both got two all-beef patties, special sauce, lettuce, cheese, pickles and onions, but their buns have sesame seeds. My buns have no seeds."
(I couldn't find the clip of this scene on youtube but here's another slice www.youtube.com/watch)
McDonald's. McDowell's. National Health Information Center. Health Information Center. What's the difference, right?
Oh, and there is also a Health Information Center on the web. www.healthinfocenter.org
If you have to hide what you really are and what your real goals are, how can the NATIONAL HEALTH INFORMATION be trusted?
Read more: http://www.politico.com/news/stories/0610/38199.html#ixzz0qC8awJUU
The buzz at ASCO is about more (and more expensive) personalized treatments – but the word on everyone’s lips is “diagnostics.”
And the question is whether FDA is going to be part of the problem or of the solution?
As the science of biologics necessitated the agency’s invention of CBER, so too does the promise of "personalized medicine" demand a new FDA bureau to further the development of 21st century diagnostics.
As CDER begat CBER so too must CDRH bring forth a new progeny. Let’s call it the Center for Diagnostics Advancement.
And let’s end the unfortunate ambiguity over the regulatory pathway for diagnostics.
FDA and NIH have launched a new website for reporting safety data.
The hope is that the Safety Reporting Portal (SRP) will streamline the process of reporting product safety issues to the FDA and NIH, with manufacturers, healthcare professionals, researchers, public health officials and consumers all able to submit an online safety report.
Currently, the site can be used to report safety problems relating to food (both human and animal), animal drugs as well as adverse events occurring on clinical trials involving human gene transfer.
Consumers can also report problems regarding pet foods and pet treats.
The website will eventually allow for safety problems with other clinical trials to be reported, as well as encompassing safety issues from products regulated by a broad array of federal agencies, such as the Environmental Protection Agency (EPA).
The FDA said it sees the site as the "first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event."
Organizations and individuals in certain professional roles, including drug manufacturers, researchers and food manufacturers, may be required by law to submit safety reports.
"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA commissioner, Margaret A Hamburg. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."
From today's edition of Britain's Daily Mail:
NHS 'preparing to cut millions of operations': Patients will lose out to ensure £20bn savings
Millions of patients face losing NHS care as bosses prepare to axe treatments to make £20billion of savings by 2014, a top doctor has warned. Among procedures being targeted by health trusts are hernias, joint replacements, ear and nose procedures, varicose veins and cataract surgery.
Dr Mark Porter, chairman of the British Medical Association's consultants committee, warned NHS bosses wanted 'wholesale reductions in budgets'.
He said primary care trusts - which commission care - are already compiling lists of 'low value' operations that would no longer be provided.
These include hip replacements for obese patients and some operations for hernias and gallstones. Procedures for varicose veins, ear and nose problems including grommets in children are also not funded in some areas.
Dr Porter said it was wrong to impose blanket bans on such procedures when some patients might benefit.
Although the Government has pledged to defend spending, trusts are preparing for a period of 'unprecedented retrenchment' to make the £20billion savings within four years, he said.
'Already NHS commissioners are drawing up lists of health interventions that must be decommissioned. Cut. Stopped. Not done any more.
'These lists are clothed in the language of evidence but they represent target reductions based on cost and volume, sometimes ignoring the potential benefit to individual patients.
'Instead, in the quest for wholesale reductions in budgets, lists of banned treatments are being compiled. This is wrong.'
Dr Porter told the BMA's annual consultants conference that hospital doctors would stand up for patients.
Earlier this year the Government's rationing body said more cuts in medical treatments are planned to save the NHS at least £600million.
Patients could find it harder to get into hospital under plans from the National Institute for health and Clinical Excellence, which advises on drugs and procedures to be funded.
Chief executive Andrew Dillon said a review of clinical guidelines will be finished by the end of the year, which will include 'evidence of overuse' of treatments to 'see what the prospects (for savings) might be'.
Nice will also push through 150 changes to medical practice aimed at saving money, from reducing prescribing of antibiotics by GPs to delaying some prostate cancer tests.
A Department of Health spokesman said: 'Savings will be implemented in a way that does not affect the quality of services and all savings will be reinvested back in the NHS.'
www.nytimes.com/2010/06/03/business/03dartmouth.html
Now the question is, what role does Don Berwick have in enabling the perpetuating the Dartmouth machine? Has he consulted for Dartmouth or any of it's holdings? Have they paid him any honoraria, covered his expenses for any event. Has he used his connections to open doors for them and did he get anything in return? We know he is close to the Wennbergs and others in the Dartmouth empire. The vice president of his own group, the Institute for Healthcare Improvement serves on the board of the Health Dialog funded Foundation for Informed Medical Decisionmaking.
The conflict of interest game is played both ways...
Those who call for FDA to adopt comparative effectiveness as a regulatory third leg are laser-beam focused on cost effectiveness. What's important is to understand the unintended consequences of such rhetoric on pharmaceutical innovation.
For a brief lesson on the environment in which innovation operates, see here.
.. http://dyn.politico.com/printstory.cfm?uuid=F0EC9357-18FE-70B2-A84DFD53A9884286
CBO Director Doug Elmendorf has posted the slides he used in a presentation on May 26th to the Institute of Medicine, titled "Health Costs and the Federal Budget." The presentation directly addresses the implications of the new laws on federal health spending and the budget.
Dr. Elmendorf's slides can be found here. Worth a look.
Death by PowerPoint indeed!
According to the results of two studies set to be presented Tuesday at the American Urological Association's annual meeting in San Francisco, an experimental spray improved sex for some men who regularly experience premature ejaculation,
Men who applied the aerosol spray, a mixture of the anesthetics lidocaine and prilocaine, reached orgasm a mean of 3 minutes 18 seconds after beginning sex, compared with about 56 seconds for those who got a placebo spray. The 539 men completing the two studies, who were randomly assigned to the real drug or the fake version, had an average time of less than 36 seconds before they took part in the research. That meant the drug was linked to a 5.5-fold increase in time before ejaculation, compared to a 1.6-fold gain for the placebo.
The spray, currently referred to as PSD502, hasn't won regulatory approval to be marketed. The company that owns rights to the product, Japan's Shionogi & Co. Ltd., says it hopes to apply to the Food and Drug Administration and is already in discussions with the agency.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
