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Yesterday the FDA released a preliminary draft of the restaurant menu labeling rules that will go into effect on March 23, 2011. A section of the health care legislation passed in March mandates that restaurants clearly display calorie information on menus, including sit down and drive through menus.
The draft guidelines can be found
Here’s the New York Times explaining why:
The findings, published online Wednesday by The New England Journal of Medicine, confirmed what palliative care specialists had long suspected. The study also, experts said, cast doubt on the decision to strike end-of-life provisions from the health care overhaul passed last year.
“It shows that palliative care is the opposite of all that rhetoric about ‘death panels,’ ” said Dr. Diane E. Meier, director of the Center to Advance Palliative Care at Mount Sinai School of Medicine and co-author of an editorial in the journal accompanying the study. “It’s not about killing Granny; it’s about keeping Granny alive as long as possible — with the best quality of life.”
They also lived longer — median survival for patients in the simultaneous-care group was 11.6 months and in the standard-care group was 8.9 months (P = .02). This survival benefit of 2.7 months is similar to that achieved with standard chemotherapy regimens.” (www.nejm.org)
The New York Times reporting makes it seem that palliative care alone was better and that it was therefore wrong to eliminate end of life counseling from Obamacare by calling it a death panel.
In fact, end of life counseling in the original version of Obamacare was not about “keeping Granny alive longer” or even palliative care.
Section 1233 of the health-care bill drafted would have paid doctors to give Medicare patients end-of-life counseling “every five years -- or sooner if the patient gets a terminal diagnosis.”
And the counseling was to include advanced care planning, including key questions and considerations, important steps, and suggested people to talk to about” living wills and durable powers of attorney, and their uses …a list of national and State-specific resources to assist consumers and their families." Not a word about living longer. To suggest now that’s what Democrats meant is absurd: If spending more money to let Granny live longer after a terminal diagnosis why keep reminding people every five years about “living wills”?
Because it’s a way of telling seniors as they get older that living longer is not very valuable. Here’s Victor Fuchs, an Obamacare advocate, economist and long time consultant to Donald Berwick and Obama’s health policy adviser Ezekiel Emanuel on technologies that extend life:
“..further gains in life expectancy will mostly mean keeping more Americans alive while they are retired and dependent on indirect transfers of funds from younger workers for much of their living expenses, health care, and social services.” Because keeping people alive longer is so…wasteful Fuchs suggests government discourage “ innovations that increase life expectancy” in favor of innovations, such as joint replacement, that improve the quality of life for both the elderly and the near-elderly.”
This is ideology masquerading as science. In fact, advances that improve quality of life also tend to improve survival especially when it comes to diseases associated with aging. And it winds up reducing or slowing the cost of treatment. Since 1996, the average per patient costs for cancer, heart disease and mental illness have declined in inflation adjusted dollars. And life expectancy continues to increase as well.
But that’s not good enough for Fuchs,Berwick and others. And just because of end of life counseling is gone, Obamacare has other tools to shorten life. One way to do it is to have the government not pay for any new technology that doesn’t meet this goal. Another is to not count spending on such innovations when determining if a health plan spent the federally required 80-85 percent of it’s premiums on medical care. Still another is paying doctors to discourage people from using new technologies by discussing their risks and lack of value.
Fuchs states: Obamacare should only pay for “innovations whose main effect is to substantially decrease cost while holding quality constant or reducing it only slightly.” Many Obamacare advocates endorse his view with enthusiasm. Yet by that standard, a combination of palliative and standard care that increases well-being and extends lives would be discouraged by government. Maybe the term “death panel” understates the problem.
According to three new studies in the latest issue of the American Journal of Hypertension, almost half of the 50 million Americans with hypertension haven't been prescribed the drug that would work best for them.
"Our current prescribing methods are very primitive. We haven't increased the success rate [in treating hypertension] in 35 years," says Michael Alderman, a blood-pressure expert at the Albert Einstein College of Medicine in New York City, and a co-author of one of the new studies.
One study shows some drugs work better in certain ethnic groups than in others. The two other studies recognize the importance of testing patients' levels of renin, a hormone produced by the kidneys, as a guide in prescribing blood-pressure medicine. Researchers in each of the studies emphasized that larger-scale trials would be necessary before the findings could become part of official treatment guidelines.
Welcome to what “personalized medicine” really means. Not “bespoke” or tailored medicines, but rather a focus on the “four rights” – the right medicine in the right dose for the right patient at the right time.
One of the studies, co-authored by Ajay Gupta of Imperial College London, looked at drug responses among 5,425 patients in various countries and across different ethnic groups. For example, in the U.K., south Asians are often given ace inhibitors as a first-line treatment, though the effectiveness of such prescriptions isn't based on any hard evidence. Dr. Gupta's study, for the first time, confirms that south Asians respond especially well to such drugs.
U.K. medical-treatment guidelines say that first-line drug therapies should be guided by a patient's age and race. (Guidelines in the U.S. don't include such suggestions – but since we’re looking at the NHS to learn about comparative effectiveness, maybe we should broaden our field of study, especially considering that our new CMS chief is such a fan of the UK model.)
And, while we're on the subject of the NHS, a brief digression. Did you see today's news that NICE has rejected Avastin for use in patients with colerectal cancer that has spread? It's the second time that the agency has issued such guidance. At the same time, NICE Chairman Sir Michael Rawlins has suggested that the best way to counteract the dearth of real science behind HTA is for drug companies to just lower their prices. Sir Michael is a bright guy and needs to do better than such a simplistic answer to the problem of 21st century HTA's lack of scientific integrity.
The two other studies focused on the hormone renin. Medical experts say few doctors today measure a patient's renin level, despite a study in the 1970s that suggested it might be used as a biomarker for prescribing the drugs. One of the new studies, involving 363 patients, confirmed the 1970s finding, showing that measuring the renin level can be an effective method for selecting a blood-pressure medication.
"These are not fundamentally novel biological discoveries," says Morris Brown, professor of clinical pharmacology at the University of Cambridge, U.K., who wasn't involved in the studies. But they constitute "a wake-up call that we should be using renin measurements as a systematic form of help" for prescribing hypertension drugs.
And it should also serve as a wake-up call to those who aren't paying close enough attention to the future of diagnostics development and approval.
From the pages of the Wall Street Journal:
Cleveland Clinic CEO Worries Comparative Effectiveness Could Stifle Innovation
By Katherine Hobson
The last time we looked at consumer effectiveness research — basically defined as identifying which health care services work best under which circumstances — it was
Now it’s the CEO of the Cleveland Clinic who’s expressing concern, as the
Cleveland Plain Dealer reported yesterday. In response to a question after a speech, Toby Cosgrove said he wanted to ensure that manufacturers and investors would still be willing to make financial bets on unproven devices and drugs. He used the example of a heart valve, saying it now takes two decades to bring a new valve product to market and then assess the effectiveness.
(Cosgrove knows of which he speaks; his bio says he has 30 patents filed, including heart valves and surgical instruments.)
The concern he’s raising isn’t so much over the comparative research itself, but what the government does with the results. If regulations deem that only the treatment judged most effective is paid for, “my concern is that .. we begin to limit what people are willing to do in terms of developing new products,” Cosgrove said, according to the paper.
Two health-care experts interviewed by the Plain Dealer said they thought the government and insurance companies understood the need to safeguard innovation.
Last year both the NIH and IOM published lists of things they’d like to see studied under CER. Included were expensive biologic drugs for auto-immune diseases, treatments for atrial fibrillation, school-based anti-obesity programs and pregnancy-prevention strategies. The co-chair of the IOM committee told the Health Blog back then that CER includes figuring out what works best for certain subgroups — say by age or gender or ethnicity.
Comparative effectiveness bonus: Read why one expert is concerned that the emphasis on CER
A: 72 billion
Q. How many chickens are in the egg producing business?
A. About 340 million.. According to USDA "U.S. egg production totaled 7.45 billion during June 2010, up 1 percent from last year. Production included
6.38 billion table eggs, and 1.07 billion hatching eggs, of which 1.00 billion were broiler-type and 69 million
were egg-type. The total number of layers during June 2010 averaged 338 million, up 1 percent from last
year. June egg production per 100 layers was 2,203 eggs, unchanged from June 2009."
Q. How many eggs are being recalled, give or take a few yolks..
A. 360 million. According to my math, that's about 5 percent of all eggs and about 15 million chickens...
That's a lot of omelettes..
Throughout all this the outcry from Congress has been nearly non-existent. Compared to the bashing FDA took under the previous president, the slience has been... welcome.
Salmonella happens.. all the time. There is more food produced more efficiently than ever before. We will recover from our egg deficit in no time. Tracking outbreaks requires more than increasing the size of the food police. It requires better tools and coordination. The last thing we need is a Food Safety Czar or a separate Food Safety Agency..
That would really be laying an egg..
It already set up a venture capital firm in Dept of Treasury to dole out $1 billiion to small companies to the projects of it's choosing. This, at a time when private VC financing for life sciences is actually up. But no matter, the biotech genuises at Treas. who I am sure have extensive investment and biotech backgrounds, will hand out tax credits that can be used to offset losses or as collateral for other funding. Sound familar?
Now comes the administration's response to their botching of the H1N1 production and distribution effort. By insisting on single doses to avoid the fearmongering of vaccine critics, HHS delayed the roll out of the vaccine by months. The snafu forced a re-examination of the government's role in preparing the nation for both pandemics and bioterrorism. Thus HHS just released " The Public Health Emergency Medical Countermeasures Review" where Secretary Sebelius said “Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,”
It's solutio for becoming nimble and flexible? More government control over the production of biotech products. There will be the Centers of Innovation for Advanced Development and Manufacturing where the government -- which not only has no expertise in either but has failed miserably -- will be building and running vaccine production facilities. As for new products, moving from the mistaken idea that all new discoveries come from NIH, " HHS will be creating new teams at the National Institutes of Health to identify promising research and facilitate its translation into vaccines, drugs, and treatments that keep Americans safe."
Once government picks winners and losers it will invest in pet projects through a strategic investment firm and give it $200 million.
Will all this make biologic countermeasure development more nimble and flexible? The government track record in product development is terrible. Worse, there is no acknowledgement of the real barriers to innovation: the failure to apply the same science of discovery to accelerate the evaluation and development of new products overall. The funding for regulatory science pushed by Sebelius misses the mark. It focuses on studying the potenetial of early stage products when in fact the FDA needs more money for later stage evaluation and more efficient ways to monitor production.
The report claims HHS will reposition government as a "strategic partner." The current proposals put the government into the biotech and vaccine business. If you like ObamaCare you will love ObamaShots.
http://www.phe.gov/Preparedness/mcm/enterprisereview/Pages/default.aspx
Subsequent to the July adcomm on Avandia, the FDA asked GSK to send a letter to doctors detailing what took place.
The first question is … why didn’t the FDA do this itself? It was, after all, an FDA event. Was a written synopsis, perhaps, too hot to handle for the folks at White Oak?
To nobody’s surprise, a certain agency employee is unhappy with GSK’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham told the New York Times. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
Some panel members agree with Dr. Graham. Panel member Dr. Curt D. Furberg, described the letter as “very Avandia friendly. Panel member Dr. Sanjay Kaul, disagreed, saying the letter “faithfully reflects the deliberations of the Avandia advisory meeting.”
Erica Jefferson, an F.D.A. spokeswoman, said that after ordering GlaxoSmithKline to send a summary of the hearing to the Tide trial investigators, the agency had relied on the company to provide a balanced account. “F.D.A. did not pre-clear or approve the content,” she said.
Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said the company had only one week to write the 10-page summary, which was necessarily brief. But the company and the leader of the Tide trial agreed that the letter “reflected the science and data discussed at the advisory committee meeting,” Ms. Rhyne said.
Avandia? Controversy? Who could have guessed?
Why didn’t the FDA write this letter?
"Please give me some good advice in your next letter. I promise not to follow it."
-- Edna St. Vincent Millay
If we learn nothing else from BP’s recent unpleasantness, it’s that being able to identify an obvious problem (like when oil is gushing uncontrolled into the Gulf of Mexico) is one thing. Identifying that there is a potential problem is tougher. And toughest of all is designing a solution that addresses a need early in the curve.
Case in point, Alzheimer’s Disease. As Gina Kolata writes in today’s New York Times, “The failure of a promising Alzheimer’s drug in clinical trials highlights the gap between diagnosis — where real progress has recently been made — and treatment of the disease.”
Alzheimer’s Disease is a healthcare oil spill of draconian proportion.
Recent significant steps forward in early diagnosis of the disease are important. And frustrating -- because there is still precious little that can be done when this devastating condition is identified either late in the game or in its nascent stages.
To say that the science is “hard” (while true) is not particularly helpful. What needs to be addressed are the twin issues of drug development and regulatory science. Both are lagging. Biomarkers notwithstanding, more needs to be done. We need better tools. Too many programs (almost 50%) are failing in late Phase III. Too many programs are mired in regulatory treacle. The economics are unsustainable from a corporate R&D standpoint and the impact of Alzheimer’s Disease on patients, their families and American healthcare economics is devastating.
Better, more current and predictable scientific research and standards must be developed and devoted to streamlining the critical path. Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle and to lower the cost of research by helping industry identify product failures earlier in the clinical trials process.
25 years ago, the success rate for a new drug used was about 14%. Today, a new medicinal compound entering Phase 1 testing—often after more than a decade of preclinical screening and evaluation—is estimated to have only an 8% chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product’s success is even lower. We have got to work together to turn that around.
When Thomas Edison was asked why he was so successful he responded, “Because I fail so much faster than everyone else.” Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number ($802 million):
* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.
* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million.
* Shifting of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.
Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle.
For all that modern science has to offer, developing new treatments is still very much an art—in which hunches, intuition, and luck play a critical role. The odds are long. For medicine that is affordable and innovative, we need more well-understood science and we need regulatory predictability. And that’s precisely the mission of the FDA’s still moribund Reagan-Udall Foundation.
To quote the late Senator Ted Kennedy, the Reagan-Udall Foundation “will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients.”
Shortly before his death, I had the privilege of a private meeting with Nobel Laureate Joshua Lederberg. The topic of conversation was the future of the FDA and the agency’s Critical Path initiative. We talked about the state of applied research and “the texture” of the agency, the prioritization of development science, biomarkers and a host of other future-oriented issues. He talked. I took a lot of notes. At the end of the meeting he put everything into perspective in a single
I hope so and so should we all. Innovation = Hope.
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.
