Latest Drugwonks' Blog
Via the Huffington Post …
The Wrong Way to Dispose of Drugs
In late April, towns across the country participated in National Prescription Drug Take-Back Day -- a nationwide event organized by the federal Drug Enforcement Agency. Local law enforcement personnel and community groups were on hand to collect and dispose of unneeded and expired prescription drugs.
Most of us don't think about the old pill bottles cluttering up our medicine cabinets. But there are actually some important safety, privacy and environmental issues surrounding the disposal of unused prescription drugs. In this respect, take-back events are worthy endeavors. But some lawmakers want to go farther and make take-back programs mandatory.
Alameda County, California, recently passed an ordinance that would do just that. The county's new law requires pharmaceutical companies to develop, manage and pay for a new local drug take-back program.
There's good reason to believe very few people will participate in this program. It is also likely to result in higher drug prices and will produce few environmental benefits.
The driving force behind the take-back programs is concern for the environment. But less than 10 percent of pharmaceutical contamination is the result of improper disposal of unused medications. The vast majority of pharmaceutical contamination results from drugs being excreted by humans into waste water -- a problem take-back programs obviously can't address.
Encouraging proper household disposal is a superior approach to tackling this problem. Trash collected from homes is usually incinerated or put into double-lined municipal landfills equipped with collection systems that keep medicines from leaching into the ground.
Consumers do need to be educated about the risks of drug disposal. For instance, some people still improperly dispose of drugs in the sink or flush them down the toilet. In general, unneeded prescription drugs should be crushed, put in bags with sawdust, kitty litter or other fillers that make them unappealing to pets and children, and then thrown out in the trash. For privacy, bottle labels should be removed and destroyed before disposal.
Home disposal also avoids the dangerous "concentration" of pharmaceuticals. When many drugs are collected all at once, there's a greater risk they will be stolen or otherwise improperly used.
Alameda's law explicitly prohibits drug makers from charging any extra fees to pay for the program. But the simple fact is that consumers across the country will pay higher prices to cover the cost of the Alameda program.
And very few people are expected to actually participate. Vancouver, B.C.'s take-back program is often cited as a model, but a decade after its launch in 1997, a survey found that only 21 percent of respondents had made use of the program -- hardly justifying the cost and new bureaucracy.
Well-publicized, one-time take-back programs like the one in late April are a good way to raise awareness and encourage people to go through their medicine cabinets and dispose of unwanted pills. But the best "next step" is to educate consumers about proper and safe household disposal. There's no justification for the kind of permanent and mandatory take-back program that Alameda County is proposing.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
U.S. District Judge Edward Korman, asked by the government on Tuesday to freeze his plan giving teenage girls broader access to morning-after birth control, instead seized the chance to accuse health officials of taking steps that would end up hurting poor people and improve their chances of prevailing in a protracted legal fight with reproductive rights advocates.
At a hearing in federal court in Brooklyn, Korman told an assistant U.S. attorney that the FDA ruling was a cynical attempt to "sugarcoat this appeal of yours."
Korman said he would issue a ruling before the end of the week on the request to stay his order. But he left little doubt about where he stood, accusing the Justice Department lawyer of "intellectual dishonesty" and calling further delays in the 12-year-old case "a charade."
"The poor, the young and African-Americans are going to be put in the position of not having access to this drug," he said. Making the same point earlier, he asked, "Is that the policy of the Obama administration?"
A new set of articles in Health Affairs about the declining rate of health care spending increases debate whether it's the recession or a slow down in the use of new technology. The authors conclude "that a host of fundamental changes—including less rapid development of imaging technology and new pharmaceuticals, increased patient cost sharing, and greater provider efficiency—were responsible for the majority of the slowdown in spending growth."
It is just the opposite.
The continuing decline since 2000 is the result of people living longer healthier lives due in large part to new devices and medicines for previously untreatable diseases. In particular, the decline in the spending rates correlates strongly with steep declines in morbidity and mortality from cancer. If you reduce the amount of people dying and being treated from a leading cause of death and illness you are going to slow the climb in health care spending.
Consider the following:
- Over the past 20 years, cancer deaths in the United States have dropped 30 percent, faster than in any time in history.
- The percentage of cancer patients who have to be hospitalized has been cut in half. The number of cancer survivors has more than doubled from about 6.8 million to 14 million today.
- That translates into 43 million additional life years worth $4.2 trillion in income.
Finally, as Frank Lichtenberg's recently updated paper on the contribution of new cancer therapies to longer life and greater value notes that "the cost of new cancer drugs is less than 1% of the value of the mortality reduction they yielded."
We need to reboot the way we pay for health care to capitalize on and encourage even more innovation. That, not a slowdown in the adoption of such technologies, will continue to make health care more affordable.
Discuss.
From the pages of the Tulsa World …
Commonsense cut to health care
By PETER PITTS
As Congress looks to slash federal spending, it ought to closely examine two health care initiatives run by alphabet-soup government bodies - one from the Agency for Health care Research and Quality (AHRQ), the other from the Patient-Centered Outcomes Research Institute (PCORI).
Over the past several years, these agencies' so-called "academic detailing" programs have spent tens of millions of dollars convincing doctors to change the way they write prescriptions. Unfortunately, these programs neglect patient health in favor of cost savings that in the long run may not amount to much of anything.
Who is the target?
"Detailing" is the practice of visiting health-care professionals to share information on the drugs they prescribe. The government's "academic detailing" is not done by actual academics, however. Rather, the agencies give an assortment of doctors, nurses, and pharmacists a set of government talking points and send them to meet with physicians and health-care professionals. Physicians are enticed into participating with the promise of continuing medical education credits, which they need to maintain their licenses and would normally pursue at their own expense.
The sessions often address drugs for diseases like diabetes, hypertension, dementia, and osteoporosis. The AHRQ now plans to expand its sessions to include guidelines on services such as mammograms and prostate screening. Each session concludes with specific recommendations regarding the doctor's prescribing habits.
Academic detailing might sound like a basic refresher course. But the government's contractors aren't reaching out to all doctors, or even focusing on those who need to improve patient care. Rather, they're targeting doctors who prescribe drugs often - even if those drugs work well, improve health, and save money over time by making hospitalization less likely.
The Department of Health and Human Services says the AHRQ program aims to promote "the cost-effective use of drugs," as opposed to practices that maximize health.
In addition, the detailers' recommendations are derived from research by PCORI and yet another government entity, the Preventive Services Task Force. This research is problematic for two reasons.
Dealing with humans
First, these studies are typically based on large-scale data sets rather than patient-by-patient analysis. The human body is complicated, and drugs that work for many patients may not work for all patients. Doctors often confront complex trade-offs - between effectiveness, interactions with other drugs, side effects, and price - that vary from patient to patient. And yet the government is advising physicians based on studies that ignore individual differences.
Second, just because this research bears the stamp of the federal government does not mean the findings are gospel and should be pushed on all doctors. Experts often disagree on important medical topics. For example, the Preventive Services Task Force recently recommended eliminating routine mammograms for women under 50. The American Cancer Society, on the other hand, continues to encourage mammograms starting at age 40.
In theory, it's possible that the detailers are presenting the research in a nuanced way - making clear that there is still a large role for physician discretion. But it's hard to know, thanks to a total lack of transparency.
As two former American Medical Association presidents noted in a recent letter, the AHRQ has failed to establish basic standards for disclosing how government money is being spent. The American people have no way of knowing how detailers are compensated, or even necessarily what they're supposed to achieve. The head of Total Therapeutic Management, a private firm contracted to conduct detailing for the AHRQ, says he measures success only by the remarkably unscientific standard of whether physicians say the sessions have been helpful.
Physicians rule
Moreover, the agency refuses to divulge which doctors are receiving visits from detailers and what they're being told - hiding behind privacy regulations designed to protect patients, despite no patients being present during these sessions.
Government detailing is also unhindered by the standard restrictions that apply when pharmaceutical representatives visit doctors - even though the government is also trying to influence doctors' prescribing habits for financial gain. For example, pharmaceutical representatives can't encourage "off-label" drug uses, and their promotional materials must be vetted by the FDA; neither of these rules applies to government detailing. And of course, pharmaceutical reps can't pay doctors to listen with continuing medical education credits.
It's time to end academic detailing. Physicians should prescribe the medicines they judge most effective, not the ones the government thinks will save money.
In a speech at the annual meeting of the National Academy of Sciences, President Obama said that scientific research mustn’t ‘fall victim to political maneuvers or agendas that in some ways would impact on the integrity of the scientific process."
Except, of course, when such interference forwards his agenda.
Plan B?
‘Nuff said.
There should be one rule for reimbursement: If a treatment is targeted and works best in a particularly patient, it should be used and paid for. Indeed, many new medicines actually save health plans and hospitals money, especially if they target a particular mutation or disease mechanism in a smaller group of patients. Why should we pay more money for medicines that are more effective and more valuable? We shouldn't. And it speaks to the issue of patients being exposed to higher copays for cancer treatments that, while expensive, a less costly than the types of care they replace. So does The Cancer Drug Coverage Parity Act, H.R. 1801 a new congressional proposal to end discrimination against patients who opt for an oral form of therapy that works best for them. Sponsored by Congressman Brian Higgins (D-NY) the legislation would require insurance companies to cover patient-administered and physician-administered anticancer drugs at the same cost to patients.
This is a piece of legislation that ensures regulation keeps up with medical innovation. Let's hope it passes and is signed into law as quickly as possible.
http://www.businesswire.com/news/home/20130502006308/en/Patients-Equal-Access-Coalition-Applauds-Bill-Improve
A new op-ed appearing in The Washington Times. Please excuse the headline – I didn’t write that. I support quality, legal generic medicines. I do not support the blatant disregard of intellectual property – or the dangerous and deleterious consequences such behavior has on the public heath.
When generics win, patients lose
Failure to protect patents stifles drug profits and innovation
A court ruling in India could stifle medical innovation worldwide.
On April 1, the Indian Supreme Court rejected a patent request for a version of the cancer treatment Gleevec, citing a 2005 law intended to thwart companies from obtaining fresh patents for minor changes to a medicine. The law itself, and the court’s decision, is a boon to India’s prosperous $26 billion generic-drug industry. The blatant failure to protect the intellectual property of biopharmaceutical innovators, though, will have terrible consequences for drug development and patient health.
Bringing a medicine to market is a long and complicated process. According to the Tufts Center for the Study of Drug Development, it takes 10 to 15 years for an experimental drug to reach the market. Including the costs of failures, each medicine costs an average $1.2 billion to develop.
Generic-drug manufacturers don’t have these massive upfront development costs. They don’t need to worry about investing in research and development for revenue. They piggyback on the research and investments of the pharmaceutical companies that create the brand names. India’s generic-drug manufacturers are among the largest in the world.
Gleevec, a cancer treatment from Swiss-based pharmaceutical company Novartis, was a major pharmaceutical breakthrough for cancer patients around the world. A patient advocacy group in Mumbai lauds it as “the only lifesaving drug” for chronic myeloid leukemia.
Gleevec is patented in nearly 40 countries, including China and Russia. Because the drug was introduced in India before the country enacted its first patent law in 2005, the treatment has gone unpatented.
When Novartis applied for a patent on a beta crystal reformulation of Gleevec, an important improvement that makes the medicine more stable, Indian regulators denied it, saying the difference between the two versions was too small. Novartis filed a petition with the Indian Supreme Court in 2009 to challenge the denial.
Novartis went to court not only to defend its patent interests for Gleevec, but also to defend the larger principle that intellectual-property protections are essential to innovation and the advances of medical science. The Indian Supreme Court’s decision essentially tells innovators not to bother improving on their products because they will reap no reward for doing so.
Some are trumpeting the case as a victory for patient access. The generic version of Gleevec costs about $175 per month per patient, compared with $2,600 for the brand-name drug.
The raw price comparison misses the point. Ninety-five percent of the 16,000 Indian patients prescribed Gleevec receive the medication at no charge through a program Novartis has established to ensure that poor, uninsured patients get the medications they need regardless of ability to pay. The other 5 percent are reimbursed or insured or are enrolled in a generous co-pay program.
Novartis has provided $1.7 billion worth of Gleevec to Indian cancer patients since 2002 and donated $2 billion worth of medicines to more than 100 million patients worldwide in 2012 alone.
Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.
Patent protection does foster continued progress. Sometimes progress comes in the form of a big breakthrough, but sometimes it’s just a matter of an incremental advance. Either way, the work behind new medicines should be protected.
The Indian Supreme Court’s ruling is a blow to global public health. India’s generic-drug industry will profit, but patients will suffer the consequences.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.
It is with mixed emotions that I write to inform you of the upcoming departure of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy (GO), after 18 years of dedicated federal government service, including 11 years spent here at FDA.
Deb has overseen various critical programs within the Agency including, most recently, the GO Directorate. In that role, Deb has led the implementation of FDA’s strategy for addressing the challenges of globalization and import safety, including the paradigm shift that FDA must make to meet the challenges of globalization today and in the future through global coalitions, global data systems, advanced risk analytics, and leveraging of the efforts of public and private third parties. Deb has outlined a strong vision for GO that focuses on being data-driven, strategic, and risk-based, moving towards a stronger global product safety net to advance and protect public health. Prior to assuming the role of Deputy Commissioner, Deb worked in several critical positions within the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER), including for five years as its Director.
Deb is leaving the Agency to take the position of Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, Inc. Please join me in wishing Deb all the best as she and her family relocate to the Pittsburgh area and embark on this new endeavor. While I am sad to see Deb go, I am happy that she has found this terrific opportunity. Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her. Deb’s last day at FDA will be June 1, 2013.
I am pleased to announce that John M. Taylor, III, currently the Counselor to the Commissioner, has graciously agreed to serve as Acting Deputy Commissioner for Global Regulatory Operations and Policy in the short term starting May 18 as we look for a permanent replacement for Deb.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
In recent weeks, there have been increasing expressions of concern from surprising quarters about the implementation of ObamaCare. Montana Sen. Max Baucus, a Democrat, called it a "train wreck." A Democratic colleague, West Virginia's Sen. Jay Rockefeller, described the massive Affordable Care Act as "beyond comprehension." Henry Chao, the government's chief technical officer in charge of putting in place the insurance exchanges mandated by the law, was quoted in the Congressional Quarterly as saying "I'm pretty nervous . . . Let's just make sure it's not a third-world experience."
These individuals are worried for good reason. The unpopular health-care law's rollout is going to be rough. It will also administer several price (and other) shocks to tens of millions of Americans.
Read the full piece 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.
