Latest Drugwonks' Blog
Only in AARP's real world.
Retail prices for some of the most widely used brand-name prescription drugs shot up more than 8 percent in 2009, even as inflation plummeted to a record low, according to a new AARP analysis of retail drug price trends released today. The AARP Rx Price Watch Report also looked at retail drug prices over the past five years and found some huge increases for popular drugs including the prostate drug Flomax, which nearly doubled in price; Advair and Aricept saw price hikes of 40 percent. During the same period, the consumer price index rose 13.3 percent. The findings show that the cost of prescription drugs—many widely used by those on Medicare—far outstripped the price increases for other consumer goods and services. … The AARP report found that all but six of 217 brand-name prescription drugs had retail price increases exceeding general inflation last year.
Conducted by long time pharma-price schlockmeister, Stephen Schodelmeyer, the "study" ignores the fact that the 217 brand name drugs were actually a smaller number of medications with different doses and that for most, if not all of the drugs, there was a generic alternative. It also ignores the fact that almost no one pays retail or the full cost of a medication or that the retail price includes drugstore mark ups..
Meanwhile, another reliable survey, this from Consumers Union, claimed that 27 percent of people skipped or split medications to save money. Then again, up to half of people who actually have drug coverage skip or stop taking medications. Did Consumers Union consider other reasons than money?
And by the way, it's survey showed that "a whopping 81 percent said they are concerned about the rewards drugmakers give to doctors who write a lot of prescriptions for a company’s drugs. And 72 percent were displeased with payments pharmaceutical companies give to doctors for testimonials or for serving as a company spokesperson for a given drug."
Rewards? Do they mean the pens or the calendars? And how much of a drug do you have prescribe to get such a nifty prize. You see, that's what passes for rewards these days since companies no longer hand out bags of jewelry and cash.
The coverage of these studies in the media was free of any analysis or context. Instead the journalists simply rewrote the press releases of the two organizations and linked to them in blogs... (You can read about both in the Kaiser Healtn News service which also substitutes for health care reporting in major newspapers around the country.)
Way to go.
www.kaiserhealthnews.org/Daily-Reports/2010/August/26/Drug-prices.aspx
In a 33-page opinion, Judge Emmet Sullivan of U.S. District Court in Washington, D.C., declined to issue a preliminary injunction blocking the sales of the generic Lovenox.
sanofi-aventis sued the FDA after the agency granted Sandoz approval to make enoxaparin (the generic form of the special heparin).
s-a contended that the FDA didn’t follow its own regulations in granting the approval. s-a, interestingly, didn’t claim that the Sandoz product was unsafe. Rather, they argued that the enoxaparin made by Sandoz is not exactly the same drug as Lovenox and therefore should not be approved or marketed as a copycat version of the blockbuster.
But has anyone ever argued that either traditional Hatch-Waxman generics or FOBS need to be 100% bioequivalent? Indeed, is that even possible? No and no. It is equivalence of functionality based on activity. The generic or the FOB has to work the same way and be designed in ways that produce such functional equivalence. But that doesn’t mean that interchangeability in prescribing is always appropriate. That, however, isn’t a legal matter. It’s a therapeutic one.
Judge Sullivan ruled that the FDA had not acted inappropriately in approving enoxaparin. "Just because the FDA … reached a conclusion at odds with the position advanced by Sanofi does not mean that the FDA's decision was arbitrary and capricious," he said, noting that it has been seven years since s-a filed a citizen's petition at the FDA objecting to generic versions of Lovenox.
He said, the FDA had presented "a satisfactory explanation for its decision." Judge Sullivan noted that none of the parties had challenged the safety of the generic enoxaparin.
And that’s the best victory for both the FDA and the public health.
For more on the issue, see here.
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
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.
