Latest Drugwonks' Blog
Roche.
Roche is leaving the Pharmaceutical Research & Manufacturers of America trade association effective June 30.
Roche describes the action as a "business decision" by "the newly combined Genentech-Roche US commercial organization."
According to the Pink Sheet, "As a practical matter, the departure will add to the strain on PhRMA for resources as it works on all fronts to build alliances and promote its reform agenda. The pending mergers of Pfizer/Wyeth and Merck/Schering-Plough will further reduce the group's core member base. The association traditionally adjusts dues following periods of consolidation."
"To be sure, if the same public program that competes with the private entities also gets to write and enforce the rules of the competition, that might create a problem. But almost all serious observers anticipate that the public program alternative currently being proposed will not also control the regulatory framework in which services are offered; it will simply be available as another option, and will survive only if it can succeed as a genuine alternative to those private companies. "
Read Op-Ed here.
Can we say delusional?
Let's take a look at how public plans work here and around the world. Do they compete like the postal service (oh sorry, no real competition) or do they set the prices and lowball providers and then just expand budgets in response to demand generated at taxpayer expense without regard to profitability, waste, corruption.
Does Medicaid compete? Medicare? How about the Indian Health Service?
Further, we already have public options such as Medicaid and SCHIP. What we don't have are more private choices that promote prevention and well-being and that should be the point of reform.
Making the government the lowball option is a bait and switch that will eliminate individual choices of health care plans. Why? Government's can tax and spend without the timely accountability that only a private choice based system protects.
Aetna's profits declined this year because it lowered prices to gain market share even as it spent more on medical services, disease management and prevention. Reform should encourage more of this and build on such efforts rather than kill them.
That's what is at stake. And more.
The panel was chaired by the always alert Julie Zawisza, CDER's Director of Communications and I was joined on the dais by Ray Kerins (Pfizer) and Steve Usdin (BioCentury).
We coverered a lot of ground, but what really was on the mind of the audience was the FDA's stance (or lack of one) on issues related to social media. We talked about DDMAC letters and the risk communications advisory committee, blogging, Facebook, Twitter -- and yes, even Cheerios. And the general consensus was that the agency was behind the curve.
I know, duh. But that's when Julie Z. stepped up to the plate with the following comment, "The FDA has no intention to stiffle the use of social media." It might have sounded like a throw-away line -- but if that sentiment is genuine (and Ms. Z, is as genuine as they come), then there's hope for FDA to be both regulator of and partner in using social media to communicate important public health information. In fact, Julie said (twice) that she was going to talk with Janet Woodcock about holding a series of external meetings on the subject of "Web 2.0."
She also, aptly, pointed out that when it comes to understanding, regulating, and using social media channels, it's important to understand that "it's not just information, but context and perspective."
You go girl.
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.
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.
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.
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.
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.
