Latest Drugwonks' Blog
On December 18, 2003 Thomas Menino, Mayor of Boston, came to the FDA for a discussion of drug importation. I was there.
I was there to hear the mayor lecture us on internet pharmacy safety. I thought he was there to engage in a dialogue. I was wrong. He was there to grandstand.
And again a few days later on “Your World With Neil Cavuto.”
How times change. According to a story in last week’s Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
Some tea party.
As if anyone has any new money to spend or tax breaks to give these days.... Then again, putting mental health coverage on par with other coverage would cost the treasury $3.4 billion (at least) over ten years. Again, not if $1 trillion is borrowed and allocated to buy up securities of unknown value....
At least no one blamed John McCain for the holdup...
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=54661
ntidepressants may damage male fertility
Last Updated: 2008-09-24 15:19:18 -0400 (Reuters Health)
LONDON (Reuters) - Common antidepressant drugs may reduce some men's fertility by damaging the DNA in their sperm, according to scientists.
A study of 35 healthy men given paroxetine - sold as Paxil or Seroxat by GlaxoSmithKline - found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.
Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. The research by Peter Schlegel and Cigdem Tanrikut of the Cornell Medical Center in New York was reported in New Scientist magazine and is due to be presented in November at a meeting of the American Society for Reproductive Medicine.
A copy of the study abstract was made available to Reuters.
"The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity," the experts concluded.
There are three words you never thought you would see strung together....
The study adds to concerns voiced by the same doctors in 2006, after finding that two men had developed low counts of healthy sperm following treatment with two different selective serotonin-reuptake inhibitors (SSRIs).
The article goes on...
Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was "alarming", although he noted the level at which damage becomes clinically significant was open to debate.
"It is a shame that the authors appear not to have conducted a randomised controlled trial which would be the most scientific way to investigate the drugs effects, but I agree that the results are of concern and need to be investigated further," he said.
Drugwonks is open to suggestions for an appropriate study design.
http://www.reutershealth.com/archive/2008/09/24/eline/links/20080924elin019.html
People in the US generally equate "universal" healthcare with "free" healthcare, "like in Europe."
Let's examine that proposition.
In America this year, a family of four with an employer-based PPO will face about $15,609 total in healthcare costs. Of this amount, the employer will pay on average $9,442, and the employee will contribute $3,492 in premiums and $2,675 for co-pays and other expenses. Employee premiums are about 6 percent of the median family’s annual income — less than what that family spends on food.
In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians may spend their own money to receive private treatment for procedures or drugs that are not covered by the government system.
Citizens of the United Kingdom pay 11 percent of each pound they make in weekly income between $198 and $1,326 for care through the state-run National Health Service, plus an additional one percent of income over $1,326 per week. That’s nearly double what Americans pay.
The co-pay for drugs is low, but many drugs are not covered, often because they are not considered cost-effective enough to justify inclusion in the government’s plan.
But what if you need one of those drugs? Well, you can kiss your NHS benefits good-bye. Anyone who uses his or her own money to buy drugs outside the NHS will find him or herself shut out of the system. (The NHS is considering becoming more benevolent by letting patients "top-off. We'll see.)
In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. This coming fall, premiums are set to be standardized — and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.
In France, employees contribute only 0.75 percent of their salaries towards medical care, but they also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the bulk of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, which costs approximately 2.5 percent of salary.
When compared to the U.S., the fact is that the health care systems in Europe and Canada don’t save citizens much at all.
Health reform is urgently needed in this country, and cost-cutting will be a critical component of any reform efforts. Despite its supporters’ claims to the contrary, government control of the healthcare marketplace is anything but a ticket to a lower-cost healthcare paradise.
"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions. It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."
Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either. But it did. But only after we had a widespread addition through clinical use.
The larger issue is how CMS sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure. This includes biological m markers of disease, disease progression, differences in treatment response and effects. This was and is the rate limiting factor that led the FDA to launch the Critical Path.
The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step. But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care.
Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19
Contact PMC for a copy of the letter it sent to CMS. It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.
http://www.personalizedmedicinecoalition.org/
Well, "conflict-free" is in the eye of the beholder. And conflict-free many academic medical centers are not.
To this point, consider the remarks that Roger Meyer, MD (Clinical Professor of Psychiatry, Georgetown University, Adjunct Professor of Psychiatry, University of Pennsylvania) offered at the recent conference held on the subject of industry-sponsored CME by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com). Dr. Meyer points out that the same accusations of conflict being leveled at industry are equally true for academic medical centers.
To view Dr. Meyer's slides (particularly slide #9, "The Impact of Commerce") along with other presentations from the CMPI event, click here.
Attention must be paid -- particularly by those who deem "health care like in England," as the "universal" solution to health care reform in the United States.
Starting next year, Eli Lilly and Co. will reveal how much money it pays physicians for speeches and consulting. According to a report in the Indianapolis Star, Lilly president and chairman, John Lechleiter, will announce the new policy in an address to the Economic Club of Indiana today.
"Lilly is striving to be a leader in improving transparency across our industry," Lechleiter said in a statement. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."
Under Lilly's registry of physician payments, they will list fees to physicians who serve the company as speakers and advisers. That information, which likely will include physicians' names and hometowns, will be posted starting in the second half of 2009 on a publicly accessible Internet database, Lilly said.
In 2011, Lilly plans to expand the database to include payments, updated annually, for clinical research and other provisions called for in the Physician Payments Sunshine Act pending in Congress.
For a big drug company to be the first to disclose its payments to doctors "takes a lot of courage," said Sen. Herbert Kohl, D-Wis., a co-sponsor with U.S. Sen. Charles Grassley, R-Iowa, of the Sunshine Act.
In 2004, Lilly became the first drug maker to voluntarily make public data on its clinical trials of new drugs. Last year it began publicly reporting its educational grants and charitable contributions, becoming the first in its industry to do so.
The complete story can be found here.
I have amended the blog and will now head out for a lunch of grits and crow.
Damn Yankees.
In the case of the Mass Health Connector for instance, it's insurance coverage without access to primary care. And by the way, the Commonwealth of MA refuses to allow retail clinics into the state. The result, newly enrolled folks are waiting a 100 days to see a doctor at Medicaid rates. And the plan is already $1 billion over budget.
http://www.boston.com/news/health/articles/2008/09/22/across_mass_wait_to_see_doctors_grows/
Obama's "plan" to extend coverage to 210,000 people in Illinois was accompanied by regs to force doctors and health plans to accept patients regardless of condition and reimburse at 30 percent lower rates than private plans. Years later people are still waiting to see doctors and the state of Illinois owes physicians nearly $2 billion in Medicaid payments.
Government financed and run healthcare is looking more and more like Fannie Mae and Freddie Mac backed mortgages, owners without assets, homes without homeowner as more and more people flood into a zone where they are encourage -- free of normal risk and responsibility and market controls -- to purchase and consume a good at an artificially reduced price in order to hit a hollow target. In the case of Freddie Mac it was home ownership. Government subsidized solutions to increasing health care coverage are largely focused on getting as many people covered as possible, burying the costs and paperwork and worrying about the impact on people and providers later. The result, over the past 15 years and as state efforts to create single payer systems have shown, has been a run up in costs and a decrease in access to care, particularly among minorities, children and the mentally ill.
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.
