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The MHRA started investigating Mr Essadki in January 2006 after receiving information from Pfizer that customers had complained about two websites advertising Viagra and Cialis for sale. On March 2006 MHRA enforcement officers, accompanied by representatives from Pfizer and Eli Lilly together with the Metropolitan Police, went to Mr Essadki’s home address and found a quantity of Viagra and Cialis tablets. These were seized along with computers, mobile phones and a laptop.
Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will not hesitate to take action against those who undermine public health. There is considerable risk to the public from obtaining medicines through unregulated websites. A medicine bought in this way has no guarantee of safety, quality or effectiveness. It could be counterfeit. It may not contain the right amount of medicine. At worst it may cause a severe side effect."
First – the operation began in March 2006 – over two years ago.
According to the Wall Street Journal, “Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa).”
“The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.”
Can anyone out there think of even one drug that the FDA wanted recalled that was not “voluntarily” recalled?
No – I didn’t think so.
(Also, isn't the FDA already an entirely independent government agency?)FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."
What does “too cozy” mean? Really, what does it mean?
Senator Grassley believes the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials.”
And what does that mean? Any evidence to back up such blowhard accusations?
Too boot, here’s some really shoddy reporting by the Journal’s Alicia Mundy,
“Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs”
She is referring to www.thoreau-fda.com/index.php.
Oops.
But who needs facts when you have red-hot rhetoric and a gullible reporter who's willing to take a leak anywhere?
Consider the Federal Register notice announcing the August 14/15 meeting of the FDA's Risk Communications advisory committee:
"The committee will meet for presentations and discussion of the scientific basis for translating principles of risk communication into practice in situations of emerging and uncertain risk."
And this is the committee that's mandated to create clear ways to discuss risk communications (or as it's cool to say in DC "Plain English").
I think it was Albert Einstein who said something along the lines of, "If you can't explain a complicated topic in a simple way -- then you don't really understand it." Read More & Comment...
What happens is the meeting of the Patient-Centric Health Leadership Forum.
This new report shares the cutting edge thinking of the folks mentioned above along with other similarly talented leaders. And the key phrase is patient-centric.
The report can be found at the top of this page or here, the first item under "reports."
A worthwhile and important read. Read More & Comment...
Experimental cures are often the last hope for dying patients in the U. K. health system. Thanks to the British government, however, many sick Britons will soon have their last hopes dashed.
Why? Pharmaceutical companies from around the world have been scaling back clinical research in the
Read more about this distressing development here:
British system discourages availability of new drugs
See for yourself:
Shaedegg Video Interview
And let us know what you think. Read More & Comment...
Today, as if in honor of the great man's passing, the FDA will announce an advisory for physicians to use a genetic test to screen patients before prescribing abacavir, a widely used drug for H.I.V. infection and AIDS.
(Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.)
According to Andrew Pollack in today’s New York Times, “The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.”
Here is the complete New York Times story
Let’s honor Dr. McKusick by fully funding the Reagan/Udall Foundation and advancing the agenda of the FDA’s Critical Path Initiative. Read More & Comment...
Early on, the Food and Drug Administration believed that the culprit was tainted tomatoes. It spent weeks trying to locate the source and failed to turn up any definitive evidence. Officials announced last week that tomatoes are safe to eat.
The agency now suspects that another kind of produce — perhaps Mexican-grown jalapeño peppers handled by a small Texas produce shipper — may have caused the outbreak.
But things could be worse. Imagine if the contaminated goods weren’t produce but instead prescription drugs, coming in from all over the world.
Sound far-fetched? It’s more likely than you might think.
Here’s the rest of the story in today’s edition of the Ft. Worth Star-Telegram:
Ft. Worth Star-Telegram Op-Ed
As the FDA struggles to find the source of contaminated produce, Congress should take time to reconsider the problems with legalizing prescription drug importation.
If it doesn’t, the results could be much worse than food poisoning. Read More & Comment...
Consider today’s story in The New York Times, “Health Plan from Obama Spurs Debate.”
Except that after you read the article, you realize that the headline should have more appropriately been, “Health Plan from Obama Spurs Derision.”
According to the Times:
“While there is consensus that the American health care system is bloated with waste, eliminating enough to save $2,500 per family would require simultaneous and synergistic solutions to a host of problems that have proved intractable for decades.”
And:
“Mr. Obama … is offering a precise “chicken in every pot” guarantee based on numbers that are largely unknowable. Furthermore, it is not completely clear what he is promising.”
And:
“But the health policy advisers who formulated the figure say it actually represents the average family’s share of savings not only in premiums paid by individuals, but also in premiums paid by employers and in tax-supported health programs like Medicare and Medicaid.
And, according to Harvard’s David Cutler (an unpaid advisor to the Obama campaign and a certified smart guy), “Our attempt to lay out one plausible scenario for the savings had created more problems than it had solved.”
And:
“But whether employers and governments respond that way cannot be guaranteed, particularly in a difficult economy. And a number of health policy experts have questioned whether the $2,500 projection is either fiscally or politically realistic. Reducing health care costs, they emphasized, means taking money from someone’s pocket and rationing care that Americans have come to expect, a recipe for stiff resistance.”
Here is a link to the complete NY Times story:
New York Times story
Well gosh, you mean that healthcare reform is going to be hard? Stop the presses. (Or, perhaps, start them.)
Another regularly bandied about “solution” is for the United States to adopt “free” healthcare, “like in Europe.”
Let’s address that shibboleth.
People in other healthcare systems often pay more than Americans do, sometimes in the form of taxes. And they may also incur high costs if they need a drug that is not covered by their health system or want to see a specialist.
In the US, a family of four with an employer-based PPO will have around $15,609 total this year in healthcare costs. Of this amount, the employer will pay $9,442 and the employee will contribute $3,492 in premiums and $2,675 on co-pays, etc. That’s about 6 percent of average family income.
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 also may spend money to receive private treatment for procedures or drugs that are not covered by the government system.
Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week. Though the co-pay for drugs is low, many drugs are not covered, often because they not considered cost efficient. And anyone who uses their own money to buy powerful but expensive drugs not paid for by the NHS finds him or herself shut out of the NHS for having gone outside the system.
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. As of fall 2008, premiums are to be standardized from the federal level 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 to 0.75 percent of their salaries towards medical care, but 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 majority 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, costing approximately 2.5 percent of salary.
For a more complete look at “myths vs. facts” of “free” European-style health care, have a look at this new article in the Journal of Life Sciences:
Journal of Life Sciences article
And if you’re ready for a barrage of reality about how patients fare under various European systems (Canada too), click here:
www.biggovhealth.org
And let the debate over real reform begin. Read More & Comment...
I just came across a new web site, www.thoreau-fda.com/index.php.
amednews.com
Insurers are the new worried well (America's Health Insurance Plans annual meeting)
In the wake of declining profits, health plan executives discuss what they need to do to remain viable. Their solution: focus on changing patient behavior.
By Emily Berry, AMNews staff. July 28, 2008.
Reports from conferences important to physicians
Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.
Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.
They got the message. As Dr. Wallace concluded, he asked the audience: "Is anyone here not in the behavior-change business?"
No hands went up.
The admonition that health plans are meant to manage care might not sound new, given that back in the early 1970s HMOs were created to do just that. But health plans are now talking about managing care not only as essential for their members' health, but essential to their own.
That message echoed throughout the AHIP Institute, the name for the annual meeting of the trade group representing health plans.
http://www.ama-assn.org/amednews/2008/07/28/bisa0728.htm
But let's not get too enthusiastic....just a couple of months ago the HMOs said they would dump patients to protect profit margins...
BUSINESS
Health plans say they'll risk losing members to protect profit margins
Meanwhile, businesses and individuals are dropping coverage in the wake of higher insurance premiums.
By Emily Berry, AMNews staff. May 19, 2008.
The nation's largest publicly traded health plans say they don't plan to temper premium increases for the sake of keeping members on their rolls -- particularly not while they are under pressure from Wall Street over what it sees as their disappointing earnings.
Article here
And let's not forget how AHIP and CBO are working together to "bend the curve" on health care by setting up a comparative effectiveness institute run by government bureaucrats.... Read More & Comment...
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