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"There seems to be this perception that there are all these kinder, gentler treatments for metastatic breast cancer, but I'm not aware of those treatments, said Dr. Kimberly Blackwell of Duke Cancer Institute.
Blackwell helped conduct the trials of Avastin in breast cancer and believes the FDA is "moving the goal posts" on the drug's effectiveness, which could discourage drugmakers from pursuing new drugs.
"If the label is withdrawn, we will not see a new drug for metastatic breast cancer for another decade," said Blackwell, who directs Duke's breast cancer program.
Watch these discussions of Avastin's use in HER-2 positive metastatic breast cancer underscores just how misleading is the claim that there is no scientific evidence to support what patients are saying."
www.ecancermedicalscience.com/tv/video-by-category.asp
tinyurl.com/6b5o8pz
www.foxnews.com/opinion/2011/06/28/fda-panel-is-deciding-life-or-death-for-my-wife/
According to a report in BioCentury, “A few weeks after finishing negotiations with FDA over a PDUFA V deal that seeks to tweak drug oversight with changes to the review process, BIO now plans to propose sweeping changes to the U.S. regulatory system.”
For example:
A progressive approval pathway to get new therapies for unmet conditions to patients rapidly; with intensive surveillance and limits on off-label prescribing if necessary
A revamping of the advisory committee process to ensure that conflict-of-interest rules do not prevent FDA from gaining access to needed expertise
A fixed term for the FDA Commissioner to insulate the agency from political pressure. BIO takes political independence a step further, calling for FDA to be removed from HHS and turned into an independent agency with a head who reports directly to the president, like the Environmental Protection Agency.
A refining of FDA’s mission to emphasize its role in biomedical innovation. To bolster FDA’s capacity to advance scientific innovation, BIO wants Congress to lift restrictions on funding the Reagan-Udall Foundation.
Further, BIO calls for the FDA to have a “chief innovation officer with “authority to pilot and develop strategies for implementation of promising scientific and regulatory approaches in review divisions.”
Underscoring the connection between regulatory innovation and PDUFA, a member of BIO’s board of directors will present the organization’s recommendations at a July 7 House Energy and Commerce Committee hearing about PDUFA.
Bravo BIO.
From the pages of the Des Moines Resister.
(Why Iowa? You know why.)
Our shortsighted plan for dealing with Medicare
By: Peter J. Pitts
First, HHS announced it would be making $42 million available to enhance coordination efforts between primary care physicians and other health care providers treating Medicare patients. An Emory University study concluded that better coordination in Medicare could save $125 billion over the next 10 years.
Second, HHS launched a $40 million effort to help states combat chronic disease.
Chronic diseases are responsible for 75 percent of our health care costs. Diabetes, heart disease and strokes alone account for nearly a trillion dollars in medical spending annually.
Both those initiatives have the promise to save money and lives. Unfortunately, they represent exactly the opposite approach to Medicare cost control set forth in last year's health care reform law.
Deep in the heart of the 2,700-page law is the creation of something called the Independent Payment Advisory Board (IPAB), a panel tasked with reining in soaring Medicare costs.
Here's how IPAB will work. The president will appoint 15 "experts" to serve on the board. Starting in 2014, they will be charged with keeping Medicare annual spending in line with designated targets. Any time spending looks to exceed its target, IPAB must draw up cuts to bring it in line.
Incredibly, IPAB's Medicare spending recommendations automatically become law whether a majority of Congress approves of them or not. Overriding IPAB requires a three-fifths majority vote in the Senate, a very high legislative hurdle. There's also no way for doctors or patients to legally or administratively challenge IPAB's decisions.
There are numerous legal problems with IPAB. A lawsuit is challenging the board's constitutionality, arguing that it has been improperly delegated authority over the federal budget (about 13 percent of the total) that constitutionally belongs to Congress.
The policy repercussions of IPAB are even worse. In meeting its spending targets, IPAB is ostensibly not permitted to ration care or adjust Medicare premiums and fees. Its main tool for cost-cutting is to lower Medicare reimbursement rates to doctors and other health care providers.
Unfortunately for Medicare patients, reimbursement rates are already well below market rates. Because of this, the number of doctors limiting or refusing Medicare patients is at an all-time high. IPAB threatens to make doctor access a major problem for Medicare.
Worse still, the scramble IPAB will produce each year to meet spending targets will deflect policymakers' attention from innovative new programs such as the two announced by HHS.
Even though the HHS primary care coordination and chronic disease initiatives are comparatively inexpensive and could eventually yield major savings, it will likely take years to measure their impact, let alone demonstrate that they're reducing costs. Not only that, they increase health care costs in the short-term.
On one hand, these two new HHS initiatives show that the Obama administration is making credible efforts to target the areas of the health care system that could produce the most savings. On the other hand, the Affordable Care Act through IPAB seeks to devalue efforts such as these in favor of squeezing doctors and other providers.
The right way forward is to get rid of IPAB and substitute for it a Medicare cost-savings plan that encourages long-term strategic thinking along the lines of these HHS studies.
The partisan acrimony over health care reform in Washington would seem to make all-new Medicare legislation unlikely. Fortuitously, though, bipartisan concern about IPAB's obvious shortcomings might prove to be the catalyst for a new and improved reform initiative.
House Budget Chairman Paul Ryan, R-Wis., has made repealing IPAB a major part of his high-profile budget proposal. Politico reports that several House Democrats have signed on to repeal IPAB. The repeal legislation's House sponsor, Phil Roe, R-Tenn., has floated the possibility of attaching repeal to the must-pass increase in the debt ceiling.
Support for IPAB is rapidly and rightly collapsing as citizens become better informed about the danger this all-powerful panel of unelected bureaucrats poses to their health care. It's time to urge Congress to get rid of IPAB and stand up for real Medicare reform.
In France the Ministry of Health has outlined a proposal to overhaul the country’s regulations on reimbursement, marketing, and safety of prescription drugs.
Details are incomplete, but Xavier Bertrand, the Minister of Health, highlighted these provisions:
- A new law on transparency and conflict of interest, to be called the “French Sunshine Act”;
- Pharma companies will be “held responsible for off-label use management with financial consequences”;
- For reimbursement, new drugs will be required to have an active comparator in Phase 3 studies,
- Products that have been on the market for some time will need to have a benefit/risk valuation prepared;
- A new tax will be created on pharma to finance physician medical education;
- A limit on sales reps beginning in hospitals (no personal detailing - only in group meetings) that may be extended to physician offices.
We’ll see. As General De Gaulle said, “How can you govern a country which has 246 varieties of cheese?”
Or, perhaps more to the point, “I have come to the conclusion that politics are too serious to be left to the politicians.”
Bien sûr -- and especially when it comes to healthcare.
Please pass the cheese.
As we count down to the launch of the Avastin hearing, BioCentury reports that seven advisors will participate at the June 28-29 hearing on FDA's proposed withdrawal of bevacizumab’s metastatic breast cancer indication -- including five who voted at a panel last July to remove the indication and one who doesn't have a vote.
Four of the five who previously voted against the Genentech Inc. drug are ODAC members: Ralph Freedman from the M.D. Anderson Cancer Center; Brent Logan from the Medical College of Wisconsin; Mikkael Sekeres from the Cleveland Clinic Taussig Cancer Institute; and Wyndham Wilson from the Center for Cancer Research at the National Cancer Institute. The fifth is patient representative and temporary voting member Natalie Compagni-Portis.
The non-voting member is industry representative Gregory Curt from AstraZeneca’s oncology division. Curt was a non-voting member on the July panel. The final advisor participating next week is ODAC member Frank Balis, who was not on the committee last July. He is from the University of Pennsylvania School of Medicine.
Director Karen Midthun (who is the presiding officer for the hearing) said some committee members who had participated in previous meetings on the breast cancer indication had rotated off the committee and will be replaced before the June 28-29 hearing.
Caution – fireworks can be dangerous.
A robust policy triptych courtesy of BioCentury.
Good News: House passes patent reform bill
The U.S. House of Representatives voted 304-117 to pass the Leahy-Smith America Invents Act (H.R. 1249). The lawmakers also passed by a vote of 283-140 a manager's amendment from Judiciary Committee Chair Lamar Smith (R-Texas) that would end diversion of fees from the U.S. Patent and Trademark Office but would require the PTO to wait for subsequent congressional appropriations acts to access excess funds. Much of the money the PTO collects from fees is currently diverted to fund other parts of the government.
In March, the U.S. Senate voted 95-5 to pass S. 23, its version of the bill. That legislation would allow the PTO to use all the money it collects from fees without fiscal year limitations.
Both bills include elements supported by the biotech industry, such as eliminating the ability of an alleged infringer to invalidate a patent based on the description of the invention's best use and creating a new post-grant review procedure. A joint congressional committee will next be appointed by the House and the Senate to iron out the differences between the two bills.
Joint Reviews: FDA, EMA to accept first application for joint review
EMA and FDA agreed to accept the first application submitted under a pilot program for parallel assessment of Quality by Design components of NDAs and MAAs. The application was submitted by Pfizer for an undisclosed product.
FDA and EMA are collaborating on reviews of seven applications from April 1, 2011 to March 31, 2014 under the program, which is intended to prevent regulatory agencies from applying Quality by Design standards inconsistently.
Preemption Coups: Supreme Court rules for preemption on generics
The U.S. Supreme Court ruled 5-4 on Thursday in Pliva Inc., et al. v. Mensing that FDA-approved labeling for generic drugs preempts claims under state tort law because federal regulations prevent generic drug manufacturers from independently changing a drug's label.
In the court's opinion, Justice Clarence Thomas wrote that today's ruling does not conflict with a 2009 decision in Wyeth v. Levine because branded drug manufacturers can add to or strengthen a drug's label without preapproval from FDA. In that case, the court held that an FDA-approved label for Phenergan promethazine from Wyeth did not preempt state tort law in a product liability suit.
After years of focusing the majority of its attention on HIV/AIDS (and to a lesser extent malaria), the global health community is finally waking up to the fact that the biggest health problems now facing developing countries are actually ‘non communicable diseases’ such as diabetes, cancer and cardiovascular disease. And not before time: 80% of global deaths from these diseases occur in developing countries, and already cause double the number of deaths that result from things we more normally associate with these parts of the world, such as infectious diseases, maternal and perinatal conditions, and malnutrition.[1]
Although the UN and its specialised health agency, the WHO, have already started discussing how to respond to this issue, real flesh should be put on the policy bones at a special UN Summit on Non-Communicable Diseases, to be held in New York in September 2011. We can expect whatever global agreement emerges from this gathering to focus on prevention (watch out Big Food and Alcohol), as well as making treatments and diagnostics more readily available in developing countries.
None of this is going to be easy, no matter what is agreed and what funds are committed in New York. The international response to the AIDS crisis in the late 1990s and 2000s highlighted the difficulties of delivering modern medicines and treatments to patients in developing countries, the vast majority of which have dilapidated health infrastructures and demoralised and underfunded health workforces, a large proportion of which has emigrated to better opportunities in countries like the US.
In order to bring some perspective to this issue, CMPI will be discussing this very issue ahead of the NY Summit in Geneva -- the administrative and policy heart of the UN. Our inaugural “Geneva Round Table” event (13th July) will focus on the challenges faced by clinics and hospitals in responding to this epidemiological shift, and we are lucky enough that Dr Eric Roodenbeke, the head of the International Hospitals Federation, has agreed to give his perspective based on his extensive knowledge of hospital policies and health systems approaches.
It should be a great event, and the guest list includes ambassadors, health attaches and other members of the UN health community. If you happen to be in Geneva on 13th July, please do drop by for what should be a most illuminating discussion!
From the pages of Advertising Age:
ANA Weighs Lawsuit With FDA Over Graphic Cigarette Labels
Trade Group: Government 'Can't Put Words in the Mouths of Advertisers'
The Association of National Advertisers says it will fight the federal government's move to slap graphic new warning labels on cigarette packs.
"We are still discussing whether we go directly with a lawsuit or whether we will enter of friend-of-the-court filing," Dan Jaffe, ANA's exec VP for government relations, told Ad Age. But "we will certainly join with others in opposing this proposal." Mr. Jaffe added that the ANA thinks the proposal is unconstitutional because "the government on its own ... can't put words in the mouths of advertisers."
The nine warning labels, unveiled Tuesday by the Food and Drug Administration, are the biggest change to cigarette packaging in more than 25 years. By September 2012, all cigarettes made or sold in the U.S. must display the images, which include graphic depictions of diseased lungs, decaying lips and teeth, a man wearing an oxygen mask and a morgue scene with a message: "Smoking can kill you."
As defenders of advertising, it's no surprise that the ANA is fighting back, as fears swirl that the government might use the momentum to more aggressively target other categories, such as alcohol. Indeed, the ANA is already on record opposing the cigarette labels, filing comments in January after the initial proposal was first unveiled. The association has also sided with six tobacco companies that are challenging in federal court the underlying Tobacco Control Act, passed with bipartisan support in Congress and signed by President Barack Obama in 2009.
But while the ANA is compelled to defend what is sees as free-speech rights, the association has a tricky task of defending Big Tobacco, hardly a sympathetic industry. Former FDA Associate Commissioner Peter Pitts, who served during the Bush administration, said: "It would be very tough for me to defend anybody who believes an anti-tobacco campaign is somehow deleterious to the national good."
He added: "Any image that scares the bejesus out of people away from cigarettes is a step in the right direction. It's been clearly shown by research that visuals are more powerful than words."
The FDA says it chose the images from a list of 36 potential warnings after reviewing scientific literature and reviewing more than 1,700 comments from various interest groups. The warning will be accompanied by a smoking-cessation-help phone number.
"The Tobacco Control Act requires FDA to provide current and potential smokers with clear and truthful information about the risks of smoking -- these warnings do that," FDA Commissioner Margaret Hamburg said in a statement.
But the ANA, in a blog post, said "this is precisely the kind of paternalism that the First Amendment does not permit."
As expected, overturned 6-3.
The ruling can be found here.
Next!
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.
