Latest Drugwonks' Blog
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.
From the Toronto Star:
Ontario is open to tinkering with drug co-payments for seniors and others on taxpayer-funded pharmacare programs as it looks for ways to curb the rapidly increasing cost of health care, Health Minister Deb Matthews says.
Doctors could also see more efforts to nudge them from a fee-for-service payment model to salaries, Matthews said Thursday in the wake of a TD Bank report warning of the “serious fiscal challenges” facing medicare.
The report said half of government spending on drugs goes to seniors with higher incomes, and suggested the wealthiest seniors get no drug coverage – an idea Matthews flatly rejected.
But while the minister said taxpayer-funded drugs for seniors, the disabled and welfare recipients would continue under a Liberal government, co-payments for seniors could change based on their income levels.
“We have a bit of that now. There are different premiums and co-pays for people at different income levels,” Matthews told reporters.
“Have we got that right? Is it something we should look at? Sure, I think it’s something we can look at.”
Under the current system, senior citizens with incomes above $16,018 a year and couples with a combined income above $24,175 now pay their first $100 in prescription costs, and after that may pay up to the maximum of $6.11 in dispensing fees for each prescription.
Seniors with incomes below those levels may be asked to pay up to $2 for each prescription.
The TD report called for “bold” changes because at the current rate of growth, health care costs would eat up 80 per cent of the government’s program spending by 2030, compared with 46 per cent now and 30 per cent in the 1990s.
“We need to have the conversation about the future of health care in Ontario,” said Matthews, echoing a line she has been using for months as the government has moved, as first reported in the Star, to tie hospital funding to services provided to patients and to link pay for hospital executives to patient outcomes.
Doctors should be paid more on a salary basis instead of on a fee-for-service basis to make them “better able to consider the cost-effectiveness of their treatment decisions,” said the TD report by well-known economists Don Drummond and Derek Burleton.
“I think that is something we should continue to really look at,” said Matthews, pointing out that many doctors on family health teams and in hospital emergency rooms are now on salary.
Speaking for doctors, the Ontario Medical Association said it is reviewing the TD report and recognizes the sustainability of health care funding is a “crucial issue.”
“We know that there is still more work to be done,” association president Dr. Mark MacLeod said in a statement, welcoming a public debate on reforming the system while protecting the interests of patients.
Is there an American who doesn’t know what an iPad is? More importantly, there are too many who don’t know about IPAB – the newly formed Independent Payment Advisory Board. That’s about to change.
Medicare payment board needs a fix
By Peter Pitts
May 26, 2010
Those who opposed the health care bill are debating whether “repeal and replace” should be the clarion call in the coming election. Regardless of how this debate turns out, those in favor of doing better should focus their immediate attention on identifying and fixing the most harmful parts of the bill. The new Independent Payment Advisory Board, or IPAB, should be a top target.
The bill that passed restructures the existing federal agency responsible for bringing down Medicare costs — the Medicare Payment Advisory Commission, or MPAC — and turns it into the IPAB.
MPAC was a group of medical experts appointed by Congress that provided nonbinding recommendations on ways to cut expenses and increase revenues in the Medicare program.
The changes embodied in the IPAB are meant to make the agency more independent and to skirt the political hurdles that have stalled cost-control efforts in the past. Board members will now be appointed by the president. And the IPAB’s policy recommendation automatically will be instituted unless Congress overrides them.
The goal of reigning in Medicare expenses is a worthy one. As is, the program’s costs are spiraling out of control: Medicare is projected to accumulate a $38 trillion budget shortfall during the next 75 years.
But this version of the IPAB likely will prove ineffectual. For one, it doesn’t have any authority over the biggest cost-drivers in Medicare.
Medicare Part A, for instance, is so expensive its reserves will be empty by 2017, according to the Medicare Trustees. Part A covers in-patient hospitals stays. By 2035, the program’s revenues will only finance about half of promised benefits.
Medicare Part B, which covers out-patient services, has similar cost problems. Administrators just raised Part B premiums on nearly a quarter of beneficiaries because expenses have gotten so high. And an analysis from the Congressional Research Service found that without substantial hikes in Part B premiums, the program’s finances are “at risk of exhaustion.”
Yet the IPAB has no power over Part A or Part B. They’re both left to keep hemorrhaging money, soaking up taxpayer dollars and compromising the economy. Lawmakers need to push to expand the agency’s purview so it can address the real causes of Medicare’s ballooning costs.
There’s also a risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the board room, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs.
The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements. Technically, Congress can cancel any such changes by passing a joint resolution within a month of their proposal. But Congress is so fractured that it’s very unlikely there will be the political will for such a move.
There need to be substantive checks against the IPAB decisions. And seniors need to be guaranteed representation during the policymaking process.
If left unaltered, Medicare could literally bankrupt this country. This IPAB is a step in the right direction, but it needs improvement. By pushing for some simple, commonsense modifications to the IPAB, those in favor of doing better could substantially bring down health care costs and improve coverage for millions without compromising their principles.
According to a report in London’s Daily Express ...
LEADING cancer experts were furious last night after yet another drug to extend the lives of patients (Nexavar) was refused on the NHS.
The decision by the Government's drugs rationing body NICE means patients with advanced liver cancer are the only ones in Europe not to have access to the sole treatment that could help them.
In some cases, the drug can enable sufferers to live for several years. Experts said there is no good reason why the hundreds of people who require the treatment should be denied the drug.
Their outrage was further fuelled yesterday by the disclosure that one NHS Trust is offering a £22,000-a-year salary to someone to remove hairs from transgender males who want to appear more feminine.
Karol Sikora, professor of cancer medicine and medical director of CancerPartnersUK said: "Today's decision is yet another kick in the teeth for patients, their families and the medical community.
The full Daily Express story can be found here:
I sympathize with those who say "it's my DNA" and I should do what I want with it but if you apply that logic to anything in life without some guideposts and limits, it leads to anarchy. Saying it's "my DNA" is actually like saying it's my way of doing arithmetric. If there is no way to validate my conclusions and apply them to the real world in a standard format chaos ensues.
My feeling, after reading Steve's post and discussing the launch with real doctors and geneticists, is that the path for Pathway needs to be more clearly marked to lead to personalized medicine but that it should be a path in the future.
Here is Steve's thoughtful and science-based take: thegenesherpa.blogspot.com/
Monday, May 24, 2010
DTC Genomics reviewed in Genetics in Medicine
I just received the May issue of Genetics in Medicine, only 24 days late. But it caught my attention for several reasons.
On Parenting
Study: Early Childhood Vaccines Don't Damage Kids' Development
Many parents worry that the vaccines recommended for a baby in the first year of life are just too much too soon for an infant's immature immune system. Those fears have fueled a growing trend of parents delaying or refusing to vaccinate their babies. But a new study in Pediatrics examined the long-term effects of delaying vaccines and found that children whose parents refused or postponed vaccines did no better than children who were vaccinated on time, when tested on things like speech, language, achievement, fine motor skills, attention, and general intellectual function seven-to-10-years later.
The news comes the same day that Andrew Wakefield, a British doctor who did more than any one person to propagate the belief that vaccines cause autism, was barred from practicing medicine in Britain. Wakefield's 1998 study, published in The Lancet, fingered the measles, mumps, and rubella (MMR) vaccine, as a cause of autism, though he looked at just 12 children. In February, The Lancet retracted his study, and Britain's regulatory group said Wakefield had been "dishonest" and "misleading" in conducting the research, including failing to disclose that he was working with lawyers who sought to sue vaccine manufacturers. Wakefield has moved to the United States.
WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.
Generic drug makers are seeking to preempt a product liability lawsuit by a woman who allegedly developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan.
The woman alleged the drug posed more serious risks than drug makers indicated on their labels.
A trial judge had dismissed the woman's lawsuit but an appeals court reinstated it last year.
The generic drug companies, including Teva Pharmaceutical Industries Ltd. ( TEVA) and Mylan Inc.'s (MYL) UDL Laboratories, said the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label.
In ruling against the generic drug makers, the St. Louis-based 8th U.S. Circuit Court of Appeals cited a 2009 Supreme Court decision against Pfizer Inc.'s (PFE) Wyeth unit that said Food and Drug Administration drug regulations do no protect a drug company from being sued under state law over drug labeling.
The 8th Circuit said Congress could have crafted a provision that preempted drug-labeling lawsuits against generic drug companies but chose not to do so.
In a short written order, the Supreme Court asked the U.S. Solicitor General's office to express the Obama administration's views on whether the court should consider the drug makers' appeal.
Take two tablets and call me in the morning.
The AMA has released its “Health Insurer Code of Conduct Principles.” There are 10 of them, but let’s focus on #5: “Medical Necessity.” Here’s what the AMA has to say:
Medical care is “necessary” when a prudent physician would provide it to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or the convenience of the patient, treating physician, or other health care provider.
And further do
Health insurers must not use financial incentives that discourage the rendering, recommending, prescribing of, or referral for medically necessary care.
And finally:
No care may be denied on the grounds that it is not “medically necessary” except by a physician qualified by education, training and expertise to evaluate the specific clinical issues.
“Health insurers should provide access to necessary health care, protect the patient-physician relationship and accurately process medical claims, but too often they are an obstacle,” said AMA President J. James Rohack, M.D. “The new Health Insurer Code of Conduct Principles will help protect patients and physicians from questionable insurance practices by holding the health insurance industry accountable.”
The AMA’s full statement along with a link to their new 10 Commandments can be found here.
And, let’s not forget who the nation’s biggest health insurer is – that’s right, Uncle Sam.
Badges? We don’t need no stinking badges.
Compliance through secret commination is a bad idea that may very well be an unintended consequence of the FDA’s nascent “Bad Ad” program.
Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber? Really? Whatever became of transparency. What’s next? Anonymous adverse event reporting?
The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law. In the Old West this was more generally referred to as a posse, or worse – a lynch mob.
For more on this issue, see this new article from Advertising Age.
Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy.
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.
