Latest Drugwonks' Blog
Jenny McCarthy has stated that with a change in diet and vitamins, her autistic son has been 'cured' - but some parents are not happy about her 'cure' statements. Jenny McCarthy's son, Evan, has been put on a special diet and has been receiving vitamin B-12 shots - and Jenny says the regimen is really working.
"I've been speaking to moms across the country who are all shouting out the same thing: 'This (diet and supplement intake) is working," Jenny says.
"It's so heartbreaking to see the medical community not support something called diet and vitamins. And it pains us, city after city after city. I see this heartbreak on these mom's faces."
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Nothing like a self-inflicted wound to start your day.
So, not only was it a no-bid contract, it was a sham one as well – hiding an inside-the-Beltway public relations deal behind the façade of a contract with a minority contractor from Alaska. (Anybody out there miss the irony?)
After being made aware of The Post's findings, FDA deputy commissioner John Dyer said he had suspended the contract and ordered an independent investigation.
Too little too late.
And check out this amateurish spin -- Qorvis’ Don Goldberg told the Post that “It was not appropriate (for the FDA) to hire Qorvis directly.” But it was okay for the agency to hire Qorvis indirectly -- via an intermediary that has no relevance to the task? Come on. And, get this – Goldberg leads Qorvis’ crisis communications practice!
When I was at the FDA as Associate Commissioner for External Relations, my budget for public outreach was zero dollars. We did consider hiring an outside PR agency and did what the agency is supposed to do – issue an RFP for the assignment. (We opted, at the end of the day, not to hire an agency.) And the budget at the time was $30,000 – ten times less than the no-bid Qorvis deal.
The National Consumers League released a survey of 1,035 prescription drug users on therapeutic substitution issues this morning. The survey was conducted by Harris Interactive. Full results and additional materials are online at www.nclnet.org/health/switching/ and the press release is at http://www.nclnet.org/news/2008/therapeutic_substitution_10012008.htm.
Patients Surveyed Want Transparency about Therapeutic Switching
- Respondents very much oppose health insurance companies providing incentives to pharmacists (55%) or physicians (55%) for switching patients to lower cost alternatives to medications.
- Vast majorities of respondents (78%) very much favor an explicit requirement to consult the physician before any and all therapeutic substitution takes place.
- Vast majorities of respondents (85%) very much favor a requirement that patients always be notified if their prescription is changed.
- A large majority of the general population are not sure if there is a law in their state that regulates therapeutic substitution (90% of the Rx users), but 50% of Rx users somewhat or very much favor legislation.
Patient Awareness of Therapeutic Switching is Low, but Patients Believe it is Happening
- As expected, awareness of the concept of therapeutic substitution – and the difference with generic substitution – is low.
– 2 of 3 prescription users are unaware therapeutic substitution
– Only 1 in 4 prescription users are unaware that therapeutic substitution involves replacing the prescribed drug with a chemically different one
- The vast majority of Rx users think that therapeutic substitution occurs at least sometimes in the
Switching Doesn’t Always Result in Positive Outcomes
- 15% of general Rx users saying that they or a family member experienced therapeutic substitution
– Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.
– More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.
– Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.
For more information including a fact sheet and full summary from Harris, please visit these sites:
- NCL Home page: http://www.nclnet.org/
- NCL Supporting materials: http://www.nclnet.org/health/switching/
- Full Harris summary is also online: http://www.nclnet.org/health/therapeutic_substitution.pdf
Check out his op-ed in today's edition of the Wall Street Journal:
McCain Is Right
On Interstate Health Insurance
Let's hope Democratic presidential candidate Barack Obama understands more about financial markets than he does about health-insurance markets. But the initial evidence isn't promising.
A recent kerfuffle between Mr. Obama and Republican presidential candidate John McCain concerned the interstate purchase of health insurance. Mr. McCain wants to allow people to buy health insurance across state lines. Mr. Obama, on the other hand, opposes the idea and seems to believe it would create an unsafe, unregulated health-insurance market.
Mr. McCain backs legislation sponsored by Arizona Rep. John Shadegg. Known as the Health Care Choice Act, it would allow individuals living in one state to purchase health insurance being sold to people living in other states. The policy would still have to meet the regulations of the state in which it is being sold, and would be subject to additional federal oversight.
In other words, the McCain-Shadegg reform would allow a person living in
About 18 million Americans today buy health insurance in the individual market because they don't have access to employer coverage or they aren't in a government-sponsored program (Medicare, Medicaid, etc.).
Many people in the employer-provided group market -- about 160 million Americans -- can already get health insurance across state lines. As a senator Mr. Obama, for example, lives in
In addition, lots of small employers who offer health insurance through state-regulated insurers have employees who live in other states. And when my youngest daughter moved from
In fact, people living in one state who buy health insurance in the individual market often move to other states, carrying their insurance policy across state lines.
Almost no problems have arisen from all of these interstate coverage options. So why are the two presidential candidates fighting about expanding interstate health-insurance options?
Mr. McCain recognizes that millions of Americans, many of them uninsured, live in states that impose numerous mandates -- there are about 1,900 mandates nationwide -- and restrictions that make health insurance unaffordable. Mr. McCain's proposal would simply let individuals faced with high prices and few options in their own state buy a regulated policy in another state.
That's how other industries work. People buy just about everything across state lines, with very few problems.
Mr. Obama ignited the latest feud by telling an audience, "So let me get this straight -- he wants to run health care like they've been running Wall Street," according to the Washington Post, implying that Mr. McCain would relax insurance regulations.
Mr. Obama opposes interstate sales for two reasons. First, he doesn't believe a market can work in health insurance. He believes it is necessary for the government to look over everybody's shoulder to make sure patients are getting the care and coverage the government thinks is appropriate at a price the government considers affordable.
Second, Mr. Obama likes benefit-rich policies that cover virtually everything, but are also very expensive. He wants people to have the types of health-insurance plans that the uninsured can't afford. He will "solve" the affordability issue by imposing price controls and regulations on insurers and drug companies, and force taxpayers to subsidize the rest of the cost.
Creating an interstate option for individuals to purchase health insurance doesn't solve every problem faced by the 45 million Americans who are uninsured. But the choice isn't between a regulated or unregulated health-insurance market. The choice is between an overregulated market favored by Mr. Obama and a regulated market favored by Mr. McCain that provides more options to help individuals afford health coverage.
To explore that question, the Center for Medicine in the Public Interest (the public policy home of drugwonks.com) will host "Physician Disempowerment: A Transatlantic Malaise," a conference on how cost-based government-run health care results in physicians having less control over the practice of medicine -- and the consequences thereof.
The event will take place from 9AM through 1PM on October 14 at the Newseum in Washington, DC.
Here's the invitation.
The fact that this event is being held one day before the final presidential debate, where health care is slotted as a major focus, is not by accident.
Policy thought leaders and physicians from the US, Canada, Sweden, Switzerland, France, and Germany will discuss the issue of physician disempowerment -- and what it means to both the practice of medicine and patient care.
The opening keynoter for this conference will be Francois Sarkozy, MD (yes, the brother of Himself).
There is no fee to attend and we hope to see you there.
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.
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.
