DrugWonks on Twitter
Tweets by @PeterPittsDrugWonks on Facebook
CMPI Videos
Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts
Indiana Governor Mitch Daniels
Montel Williams, Emmy Award-Winning Talk Show Host
Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine
CMPI president Peter J. Pitts
CMPI Web Video: "Science or Celebrity"
Tabloid Medicine
Check Out CMPI's Book
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
CMPI Events
Donate
CMPI Reports
Blog Roll
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
DrugWonks Blog
According to President, Hugo Chavez, “we consider that patents cannot be a restriction or a trap ... An invention or a scientific discovery should be knowledge for the world, especially medicine,” said Chavez, adding: “that a laboratory does not allow us to make a medicine because they have the patent - no, no, no.”
The proposals were announced on national television by the Minister of Trade, Eduardo Saman, who told the nation that “patents have become a barrier to production, and we cannot allow barriers to the access of medicine or transnational medicine companies to impose their rights on the Venezuelan people."
“We are revising all the doctrines and laws related to patents, which should be compatible with the international treaties that we have signed and respect and honor,” he added.
But, there’s always enough money to invest in a vast military. So much for “respect and honor.
Read More & Comment...
Last time the prescription drug plan for senior citizens was in the news it was being vilified by many members of the majority party. Some even saw it as an election wedge issue. And then there was the whole Non-Interference Clause thing.
And then the politios and pundits saw that Part D was a huge success with America's seniors and coming in well under budget projections. And that was the last we heard of it.
Until yesterday.
Yesterday's announcement of the $80 million deal not only put Part D back on Page One -- but also introduced a new fan -- President Barack Obama. Now, it seems, we have a President who embraces the program designed to maximize free-market public/private partnerships and provide maximum healthcare choices for program participants.
Who'd a thunk it?
This plan will also do away with the silly Catch 22 of not being able to include medicines provided via patient assistance programs (PAPs) towards spanning the infamous donut hole -- something that the Bush Administration was not able to do. It's kind of a Nixion-going-to-China thing, although I'm sure the President would wince at such a comparison.
Maybe it would be more palatable to say that, when it comes to healthcare reform ... it takes a village.
Read More & Comment...
Sorry. And I know how excited everyone is and everything.
FDA regulation of tobacco? Bad idea. Really.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. With FDA as the nation's tobacco Tsarcoe Selo it will be difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs. After all, now it’s the FDA’s responsibility.
Can you say “FEMA?
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program will be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself -- is that really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
Sorry about that. Really sorry.
Read More & Comment...
Read More & Comment...
I recently participated in the 9th France/USA AGIPHARM Conference. This year’s event was held in
* Edouard Croufer (Director, Healthcare & Chemical Practice, Arthur D. Little), declared that the pharmaceutical industry needed a new model – that Pharma needs to move from “find a molecule and market it” to “identify a need and find a solution.” When I pointed out to him that the latter was precisely what the industry is currently doing, he … agreed! Nothing like having the strength of yor convictions. As Henri Poincaré said, “To doubt everything, or, to believe everything, are two equally convenient solutions; both dispense with the necessity of reflection." Croufer also pointed out that 21st success for medicines would be realized through “speed and intensity.” Amen.
* Francois Meyer (Director, Haute Autorité De Santé) made a rather revolutionary statement for the head of a national reimbursement authority when he stated that “we must move beyond clinical trials” to make true 21st century healthcare technology assessments. He also spoke to the need to include outcomes data in reimbursement decisions – or rather in the revisiting of already-decided reimbursement decisions. Or as he put it, “comparative efficacy in real life.” Heady stuff.
* Relative to the development of public/private partnerships, Patrice Jaillon (President of GIP CENGEPS – the
* All well and good until Noel Renaudin (President of the CEM – the comité économique du medicament), the Grand Fromage of healthcare reimbursement in
Particle accelerators are, after all, about high-speed collisions.
Officials said Saturday that the White House, lawmakers and the pharmaceutical industry had struck a deal to have drug companies pay $80 billion to help narrow a gap in coverage in the prescription drug program for Medicare. The officials said that the agreement would have drug companies pay part of the cost of brand name drugs for lower and middle-income older people in the "doughnut hole." That term refers to a feature of the current drug program that requires beneficiaries to pay the entire cost of prescriptions after initial coverage is exhausted but before catastrophic coverage begins.
Obama seized on the deal as evidence that his efforts are gaining momentum.
"Key sectors of the health care industry acknowledge what American families and businesses already know — that the status quo is no longer sustainable," the president said, and noted: "We are at a turning point in America's journey toward health care reform."
So drug and biotech companies are finally being permitted what they wanted to do all along but were banned from doing -- giving seniors a discount to give them a seamless drug benefit. That makes sense since the decision about what drug to take should be what works, not the price or cost. At least that is what the evidence says. And making that decision on clinical evidence leads to value based benefit designs which focus on overall health outcomes...
All to the good. And the rationale, in part, to Medicare Advantage pay more for prescription drugs.
But what is Obama proposing to fill the nearly $2 trillion gap to shove 25 million people into public health plans.
"Obama has proposed cuts in Medicare spending on hospitals, prescription drugs and other services, but a political consensus is far from certain."
He has proposed eliminating Medicare advantage, which has primarliy benefited the chronically ill and minorities... Leaving them with what?
So just as the private sector provides seniors with a solution that moves us towards a preventive approach to health care Obama is pillaging the one part of Medicare that provides just that to prop up a health plan that cannot even support paying for preventive care....
The cynicism is breathtaking and the mainstream media is too busy fawning to take note. Real health care reform is within reach but not the way the President wants to take us...
Read article here.
Here's the story, courtesy of Politico:
Drug firms reach $80 billion deal

By: Carrie Budoff Brown and Mike Allen 

Giving a boost to health legislation after a bruising week, pharmaceutical companies have offered Congress and the White House an $80 billion commitment over 10 years to help pay for comprehensive reform, negotiators told POLITICO on Saturday. 

The promised savings from the industry are to be written into the new law, making them binding. The deal is to be announced soon by President Barack Obama or the Senate Finance Committee. 

Obama was relying on drug-makers to help finance his $1 trillion health care overhaul. The deal provides a lift to the administration’s efforts to regain momentum in the debate after a tough week in which congressional budget analysts returned eye-popping cost estimates on proposed bills, and even some Democrats dug in their heels against the high costs. 

“You’ve got your first passengers on the train and now you can start moving forward down the track,” said an industry source close to the negotiations. 

The offer was approved on a conference call Friday afternoon by the governance committee of the Pharmaceutical Research and Manufacturers of America, which represents top drug and biotechnology companies. 


Afterward, PhRMA President and CEO Billy Tauzin called Senate Finance Committee Chairman Max Baucus (D-Mont.). The White House was then notified. PhRMA’s board had discussed the parameters of the deal during a board meeting in Washington on Thursday. 

House and Senate Democrats have increasingly raised the idea of using the health-care bill as a vehicle to begin narrowing the so-called "doughnut hole" — a coverage gap in the Medicare Part D plan that forces seniors to pay out of pocket for some of their drugs, above a certain cost. 

Three senators called on Baucus this week to address this gap in the Senate reform package, and House committee chairmen agreed Friday to deal with it in their legislation. 

Under the deal, a senior who makes $80,000 to $85,000 will effectively have their out-of-pocket costs cut in half, an industry official said.


The two main prongs of the agreement among PhRMA, congressional leaders and the White House: 

— Drug companies will provide a 50 percent discount to most beneficiaries on brand-name medicines covered by a patient’s Part D plan when purchased in the coverage gap. 

—The entire negotiated price of the Part D covered medicine purchased in the coverage gap would count toward the beneficiary’s out-of-pocket costs. That would lower the beneficiary’s total out-of-pocket spending. The proposal would not require any additional paperwork on the part of the beneficiary nor would an asset test be used for eligibility. 

Most plans in the Medicare drug program, which began in 2006, included a gap in coverage. The cost of drugs are covered until the beneficiary and the government had spent $2,250. At that point, individuals have to pay 100 percent of the costs until reaching $5,100 for the year, and then the government coverage kicks in again. That gap between $2,250 and $5,100 is often referred to as "the doughnut hole." 


The agreement couldn’t come at a better time for Obama and Baucus. It blunts charges that Democrats aren't concerned about the cost of the overhaul. And with this deal, they are showing that the industry remains at the table, and willing to deal. This could put pressure on other industries to deal as well. 

PhRMA has been negotiating the deal for months with Baucus and his staff, and with Nancy-Ann DeParle, director of the White House Office of Health Reform.
“This is a huge amount of money,” said an industry official. “Our CEOs tossed and turned in their beds for a long time before signing off on this. It’s going to provide a significant amount of money toward achieving health-care reform.” 

The official added: “We recognize that there has to be a shared sacrifice if we’re going to extend health-care coverage to everybody in America.” 

Obama hinted at the negotiations in his radio and Web address last week, when he outlined about $75 billion in savings that could come from lower payments for prescription drugs – money that could be used to pay for his $1 trillion health care overhaul. White House budget director Peter Orszag told reporters at the time that the administration was “in discussions with stakeholders over the best way of achieving that $75 billion.” 


But even the $80 billion is just one part of a massive health-reform tab that the Congressional Budget Office said this week is likely to cost more than $1 trillion – a number that many Republicans and even some Democrats say is too much. Obama has announced a package of tax increases, cuts in hospital and other reimbursements and other savings that he says add up to $950 billion to pay for a health overhaul, but Congress has balked at some of his proposals and it’s not yet clear if others would achieve all the savings he hopes.
Read More & Comment...
Read more here
Read More & Comment...
"What was originally offered up as a down payment on healthcare reform simply can't be accurately estimated by the CBO and will result in far less savings than the originally promised $2 trillion," said Republican senator Mike Enzi of Wyoming, the ranking member of the Senate health committee. "The administration will need to come up with far greater savings proposals – savings that Congress can take to the bank – to achieve the massive healthcare bill Democrats are proposing."
(In May, President Obama announced that six groups– had pledged to reduce healthcare spending growth by 1.5 percentage points annually over 10 years, saving an estimated $2 trillion. Within days of the announcement, reports surfaced that the groups had planned to ramp up to the 1.5 percentage point level over time, rather than committing to such savings annually.)
According to the CBO, extending prescription drug coverage to the entire population "would probably increase the deficit significantly", the CBO said. It also cited its December 2008 estimate that establishing a biosilimar approval pathway would yield federal savings of about $10 billion over the next decade. The December report estimated that an FOB measure with 12 years of innovator exclusivity would generate federal healthcare savings of $9.1-11.7 billion, with the larger figure contingent upon placement of FOBs in the same billing code as their branded counterparts for payments under the Medicare Part B program.
According to a story in SCRIP World Pharmaceutical News, “The budget office's brief analysis was released as healthcare reform activity in Washington reached a fevered pitch, much of it focused on the costs of a massive overhaul. Among the activity of note, the CBO released higher-than-expected cost estimates for reform legislation being considered by the Senate health committee, and the Obama Administration said it was working with Congress to extract $22 billion in savings over 10 years from the Part D drug programme, including lowering reimbursement of medicines for "dually eligible" individuals who qualify for both Medicare and Medicaid.”
Relative to the Affordable Health Choices Act, the CBO estimated the measure would cost the federal government $1 trillion over 10 years and result in a net decrease in the number of uninsured people by only 16 million.
Yeah – reality bites.
Read More & Comment...
"Let me be clear, I want to clear something up here: identifying what works is not about dictating what kind of care should be provided," the president declared. "It's about providing patients and doctors with information they need to make the best medical decisions. I have the assumption that if you have good information about what makes your patients well, that's what you're going to do. I have confidence in that. We're not going to need to force you to do it; we just need to make sure you've got the best information available."
The words are the right words. But actions, as they say, speak louder.
Read More & Comment...
“The Food and Drug Administration told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”
Here’s the public health headline – It’s time to reform DSHEA.
In May 2007, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
That ruling was good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
It was a good question in May 2007; it’s a crucial public health question in June 2009. As an advisor to President Obama’s FDA transition team I raised the issue of DSHEA and at a recent meeting with Drs. Hamburg and Sharfstein I raised it again.
Oftentimes it takes an event (such as the Zicam action) to drive legislative change. Hopefully this will be one such opportunity.
DSHEA -- It's time for a change.
Read More & Comment...
It is a decidely bi-partisan and eclectic group that share a geniune concern about the future of biomedical innovation and whether it will come out whole in health care reform. I am an a priori skepticism about the value of such entities (my feeling about rock group re-union tours) but sincerity counts for a lot and this group has a passion for the issue, which of course I share. And they have framed the issues clearly as you can tell from the video. Coming to a town near you.
Click Here to View the Video
Read More & Comment...
By Robert M. Goldberg
Posted June 16, 2009
Bonaparte famously said to "never ascribe to malice that which can adequately be explained by incompetence."
Thus stands the Kennedy health care bill, placeholder for the hard left dream of a government takeover of the American health system. The bill is a taxpayer-supported monument to the lethal stupidity of this statist objective that will leave Americans with fewer choices, more government control over medical decisions, higher taxes, and a smaller private health insurance market (mostly union health plans paid for by taxes on the health benefits of non-union workers) that punishes efforts to reward healthy behavior.
Over ten years: 16 million more people with new insurance, 23 million forced into public plans. A trillion dollars at least. By way of comparison, from 1997 to 2006 the number of people with private health insurance grew by 5.4 million, while Medicaid and SCHIP coverage grew by 13 million for a total of 18.4 million. Total cost to the government: $40 billion. Total health care spending over that time period increased by one trillion. Meanwhile, most of the public health care coverage increase during that time -- 60 percent according to a Harvard University study -- displaced private health insurance coverage.
Could the Kennedy bill be any more inefficient at using taxpayer dollars to subsidize misshapen forms of health care coverage? Of course it could. And it is.
Yesterday President Obama told the American Medical Association that "a big part of what led General Motors and Chrysler into trouble were the huge costs they racked up providing health care for their workers -- costs that made them less profitable and less competitive with automakers around the world."
"If we do not fix our health care system America may go the way of GM -- paying more, getting less, and going broke."
Which is why Section 133 of the Kennedy bill grandfathers in every union-negotiated health plan that apes union health plans for workers and prohibits companies from transferring workers into the public "option."
Worried about the cost of retiree health benefits? No problem. "There is established in the Treasury of the United States a trust fund to be known as the Retiree Reserve Trust Fund that shall consist of such amounts as may be appropriated or credited to the Trust Fund as provided for in this subsection to enable the Secretary to carry out the program under this section. Such amounts shall remain available until expended." ("Such amounts" is Washingtonspeak for bottomless pit.) It pays for insurance benefits and 80 percent of claims from $15,000 to $90,000 for all retirees (ages 54-64). Initial cost of this "trust fund": $10 billion.
The Kennedy bill pays for $1 trillion in ineptitude in four ways.
First, it borrows. But who's counting or keeping track?
Second, it creates "Gateways" that are supposed to create groups of purchasers to reduce the cost of insurance. In fact, since insurance companies have already made it clear that they can provide guaranteed coverage without regard to the size of purchasing pools, why are such Gateways necessary? Because, as agents of the federal government, Gateways collect a tax on the insurance premiums of the young, healthy and health-conscious to subsidize the cost of insurance for those who now have no incentive to improve their health.
In fact, insurance plans that actually do a better job of controlling costs or keeping premiums low with better quality are punished under the Kennedy bill: "Any State or participating State shall assess a charge on health plans and health insurance issuer (with respect to health insurance coverage) if the actuarial risk of the enrollees of such plans or coverage for a year is less than the average actuarial risk of all enrollees in all plans or coverage in such State for such years."
Third, in order to subsidize the sort of health plans that broke the bank at GM, the Kennedy bill taxes the health benefits of others, particular those in self-insured corporations that are doing the most innovative things to improve quality and reduce costs.
Fourth, the Kennedy bill gives a Medical Advisory Council power to determine what new technologies and benefits can be covered and are introduced. It's the same technique Obama wants to use to curb the rate of growth in Medicare. John McCain suggested paying for his health care tax credit plan with Medicare savings. During the election, Obama said that "would mean fewer places to get care, and less freedom to choose your own doctors…. I don't think that's right."
Today, Obama would slash payments and choices to seniors -- mostly the sickest -- to help pay for GM-type health plans, retiree slush funds, and the mass relocation of middle-class Americans into a richer version of the Indian Health Service. On top of that, the Kennedy bill costs $1 trillion to "cover" 16 million new people in the process. By tossing 40 million out of private insurance no less. Not only is it not right. It's incompetent.
Read More & Comment...
Read more here
Read More & Comment...
ADHD Meds May Hike Kids' Heart Risks
Dr. Jennifer Ashton Discusses New Research Linking Stimulant Drugs and Sudden Death
NEW YORK, June 15, 2009
(CBS) Are ADHD medications safe for children?
Research released Monday by The American Journal of Psychiatry gives more support to the claim that stimulant drugs usually prescribed for ADHD could increase the risk of sudden unexplained death in children. On The Early Show Monday, CBS News medical correspondent Dr. Jennifer Ashton what the study might mean for the 2.5 million children taking medication for the disorder.
Ashton said alternative therapies, such as chiropractic care or dietary changes, are also available for children with ADHD. She said they can be used as a replacement or compliment to their current treatment.
Yeah... Cina, also known as octopus cactus from Mexico, that is supposed to work too.
Meanwhile the FDA rode the rescue with a dose of sanity....
FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
June 15, 2009
--the difference in circumstance of death may have accounted for a difference in family or caregiver recall of information relating to medication use at the time of death;
--sudden unexplained death in a child would be more likely to trigger a post-mortem inquiry into the cause of death than death due to blunt force trauma as a result of a motor vehicle collision; and
--there was a low frequency of stimulant use reported in both the study group and the control group.
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Read More & Comment...
Subcommittee Chairman Frank Pallone (D, NJ) said the panel would hold additional hearings that would include FDA and address product safety issues.
Rep. Anna Eshoo (D, CA) “wrangled with Pallone about submitting into the record a letter written by FDA's then Chief Medical Officer Frank Torti that raised serious questions about the approvability of follow-on biologics.”
"These are the ones from the previous administration?" Pallone asked. "We've asked them again in the current administration."
Does Mr. Pallone realize that the career officials who answered his questions the first time are the ones who will answer him once again? Is he hoping that politics will trump science and the FDA will give him a different answer to the same question? Obviously so.
And hurrah for Representative Eshoo for sticking to her guns. We’re big fans – especially since she graced the recent launch of the Center for Medicine in the Public Interest’s Odyssey Project -- a new initiative to ensure that support for medical innovation remains a top priority in any healthcare reform effort.
Representative Eshoo took the opportunity to speak about follow-on biologics with great intelligence, passion, and poise – three things we could use of as we debate this important topic. To view her remarks, go to www.cmpi.org and click on the video still of the woman in the stylish pink suit.
Eshoo? Gesundheit.
Read More & Comment...
Read More & Comment...
Initially, the federal government would likely honor its promise of higher reimbursement rates. But with millions more of Americans under a government plan, budget realities would take precedence over grandiose political promises.
Read More & Comment...
There was less said about the role and impact of biomedical innovation on health care costs and society in general but here too there was agreement that more time and effort should be spent educating policymakers and the public about what innovation is and what it delivers.
Aspen's Health Stewardship Project plays and should play an important role in making health and innovation the cornerstones of health care reform.
Read More & Comment...
Social Networks
Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS
Add This Blog to my Technorati Favorites