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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.
According to incoming PhRMA Chairman Robert Hugin (chairman and CEO of Celgene), the advocacy group’s agenda in the coming year will target policies that “most directly affect innovation and patient access to medicines.”
Bravo.
Starting with Medicare, PhRMA will focus the conversation on why policies that seek to control costs by targeting drug spending will hurt patients. Hugin: “We have to have a good defense; we have to play this part of the game.”
In short, it falls to PhRMA to lead the fight for “sustainable innovation.”
Hugin highlights two main areas of concern related to Medicare. First, he said. “We have to protect Medicare Part D. It is the role model for market-based solutions.” Next he pointed to an increasing concern in industry with retaining adequate reimbursement for drugs provided under Medicare Part B (generall administered by physicians). The growth in very high-priced specialty drugs, such as targeted cancer therapies, is contributing to a new focus among payers on containing Part B drug costs.
Hugin: “We have to defend Part B. We have to ensure that reimbursement rates don’t change so significantly that access to patients for those types of medicines, physician-administered, are restricted, and [that] leads patients back to hospitals and higher [overall medical] costs.”
Among the other advocacy priorities, Hugin points to the need to “ensure the 340B program is administered effectively and appropriately.”
Amen.
According to Hugin, PhRMA will also focus on making sure the 12-year marketing exclusivity available to biologics under the law for biosimilars “is maintained, not just in this country, but in all the trade agreements that our country negotiates.” He also said that industry must “assertively defend intellectual property all across the globe.”
As per state exchanges and other codicils of the Affordable Care Act, Hugin stressed that, “We have to make sure that we support initiatives that … do not restrict access to important innovative medicines for patients all across this country.” And he vowed to “continue the fight” to repeal the Independent Payment Advisory Board, which was established by the ACA.
The biopharmaceutical industry, per Chairman Bob, must continue to support FDA and ensure “proper funding” of drug review programs “so that we have a 21st century regulatory science system that allows us, in the most cost-effective and rapid way, to bring new therapies to patients.” He commented that the trade association’s experience in negotiating the most recent prescription drug user fee act reauthorization bill, which was enacted last year with bipartisan support, was a “remarkably” positive one.
Nobody said it was going to be easy.
When it comes to biologics, "the product is the process." Since the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.
As we move (albeit cautiously) into the era of biosimilars, one of the hoped-for advances is in manufacturing. Saying that such technologies are complicated is an understatement.
To achieve real success towards “better, faster, cheaper,” it is in the best interests of the public health for process mavens to work closely with the FDA to determine how new technologies can be expeditiously incorporated into biologics manufacturing standards.
Perhaps its time for the time for the FDA to create an advisory committee on biologics manufacturing standards and practices.
From today’s edition of the South Florida Sun Sentinel
Low costs medicines could jeopardize patient health
In Florida's House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today's most-advanced medicines.
Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It's critical for lawmakers to revert to their original proposal.
The legislation under consideration deals with a new class of medicines known as "biologics."
Unlike conventional drugs, which are made using basic chemical reactions, biologics are actually grown using living organisms. So they're much more complex. Consequently, when the patent on a biologic expires, competitors aren't able to make exact copies. But they can come close — so imitation biologics are called "biosimilars" instead of "generics."
Under federal law, the Food and Drug Administration will soon begin approving biosimilars. But the agency doesn't plan to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs. And, it's not within the FDA's jurisdiction to tell states how to address the substitution of interchangeable biosimilars at the pharmacy — that responsibility falls to the state.
When Florida lawmakers in both chambers started work on their bills, they were model pieces of legislation — striking a balance between ensuring patient safety, and creating open access for more affordable new treatments.
The original bills stipulated Florida pharmacists would only be allowed to substitute a biosimilar for its brand counterpart if the FDA had certified the medicine as interchangeable with the innovator biologic.
The human body is complicated, of course, so it's possible that some biosimilars — even those deemed interchangeable by the FDA — will not work properly for certain patients, and because of the interaction of these treatments with a patient's immune system serious consequences can result.
The original legislation also required pharmacists to notify patients if a substitution had been made. And, because adverse reactions may not manifest themselves immediately, the bill also asked pharmacists to maintain dispensing records for four years. In the event that a biologic or biosimilar does not provide the intended treatment outcome, such records will prove vital.
Finally, and most importantly, the bill required pharmacists to notify prescribing physicians within ten days if a substitution had been made. It's important to underscore that this notification is required after the patient has already received the biosimilar.
These are all commonsense ssafeguards. They ensure that patients can access these less expensive new modifications safely.
But over the past week, House and Senate lawmakers have stripped the physician notification from their bill. This doesn't make sense — it ignores the most fundamental aspect of protecting the patient by cutting doctors out of the loop.
This change undermines patient safety. Biologics are incredibly complex — on average, they contain 1,000 times the number of atoms found in conventional chemical drugs. Doctors, especially those treating patients with multiple chronic or autoimmune conditions, need to know when their patients walk away from the pharmacy counter with a different medicine than the one they prescribed.
This change also undercuts physician autonomy and ignores the importance of transparency. In order to effectively treat their patients and protect against unintended health effects, doctors have the right to know if a substitution is made.
In both the House and the Senate, the earlier draft of the bill puts patients first. As lawmakers finalize this measure, it's critical that they fulfill their responsibility to keep patients at the cent of this debate, and to make sure that the legislation passes with all protections intact.
Peter J. Pitts, a former FDA Associate Commissioner, is the president of the Center for Medicine in the Public Interest.
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.
