Latest Drugwonks' Blog
Israel is finally off the USTR’s “Special 301” list.
(The Special 301 list identifies countries that do not provide "adequate and effective" protection of intellectual property rights or "fair and equitable market access to United States persons that rely upon intellectual property rights.)
For many years the Israeli government, under pressure from Teva (Israel’s “national champion” in pharma), pursued a misguided resistance to bringing their national IP regime into full compliance with its WTO obligations.
But in recent years the mood has been shifting as more policy-makers woke up to the fact that you can have thriving generics manufacturers and a thriving innovative biopharmaceutical industry. IP, after all, is the cornerstone to a thriving life sciences industry.
According to Israel’s Minister of Economy, Naftali Bennett, "We've shown maturity and responsibility in one of the most significant areas to international trade as we have committed, and I believe that the important vote of confidence in the U.S. and recognition of the strength of the intellectual property regime in Israel, will assist us in maintaining Israeli industrial development and dissemination of knowledge, innovation and capabilities to many countries.”
Globally, every nation that’s home to a robust innovative life sciences sector offers strong and (in many cases) improving IP environments. If Israel wants to maintain its competitiveness, it needs to be competitive in IP.
Israel now has an IP sector worthy of its potential in the high value added IT, Life Sciences and other high value-added, knowledge intensive sectors. Mazel tov.
At a time when certain circles in India, South Africa, and Brazil are arguing to weaken their national IP standards, Israel has taken a significant step to secure its place in the winner’s circle.
It’s time to add a gold IP star to the Star of David.
L’chaim!
The FDA’s suggested changes to the Nutrition Facts Panel (aka, “the food label”) comes almost exactly 11 years after the FDA first announced its intentions.
These “new” changes are actually follow-through on the FDA’s 2003 Obesity Working Group recommendations. I was pleased to serve on that committee and am thrilled that our suggestions are finally being implemented.
Labels have not kept up with the supersizing of food. The Nutrition Facts Panel should empower consumers to make wise nutritional choices. The NFP was created via the 1990 Nutritional Labeling and Education Act, and the “E” in NLEA has been silent long enough.
Unfortunately, that does not include most people (who thought that the ACA meant "free healthcare") and members of Congress (who didn't read the bill -- like Nancy Pelosi) -- but it's going to make a lot of difference to to a lot of people in November.
NEW YORK (AP) - The new health care law may raise insurance premiums for 11 million small business employees and lower rates for 6 million others.
That's an estimate from a report by the Centers for Medicare & Medicaid Services, part of the Department of Health and Human Services.
The report says higher rates are partly due to the law's requirement that premiums can no longer be based on a person's age. That has sent premiums higher for younger workers, and lower for older ones.
The estimate is far from certain, partly because many small businesses renewed their policies in 2013. Renewing before the end of the year allowed them to avoid higher premiums that went into effect Jan. 1, when coverage was required to conform to the law.
Also limiting the certainty of the estimate is the fact that the report looks at three specific provisions of the Affordable Care Act. Employers' decisions will be based on more factors, according to the Centers for Medicare & Medicaid Services.
Humana is working with CoverMyMeds, a health IT company, to roll out an electronic prior authorization model that enables physicians to simplify prescription prior authorization requests so patients can get quicker access to their medications.
According to an article in Medical Practice Insider, Prior authorization (PA) is a complex process that is often daunting and monotonous for medical practice managers. It is also costly in terms of economics and human life, in particular when PA requirements lead to patient medication needs “falling through the cracks,” as some patients abandon their prescriptions due to the confusion and delay of the approval process.
The original goal of PA was to save money, requiring physicians to justify to health plans the need for medications, diagnostic tests and procedures, but it has led to pharmacists having to spend an average of five hours per week handling PA requests. This is non-reimbursable time that is better served on direct patient care.
A nationwide physician survey indicates that more than 69 percent of physicians typically wait several days to receive a PA from an insurer for a prescribed drug, while 10 percent wait more than a week. While more than 52 percent of office-based prescribers utilize electronic prescribing methods, most of them continue to use paper-based methods for obtaining PA of medications from health plans, causing unnecessary delays for patients.
Under the agreement with CoverMyMeds, physicians submit drug prior authorizations directly to the insurer through an online portal. The requests begin processing immediately, and providers receive a notification of the status of the member’s prior authorization, sometimes while the patient is still at the provider’s office, Humana said in a news release.In a pilot of the model, Humana found that one quarter of prior authorizations placed received a response electronically within minutes of submission. Physicians who used it overwhelmingly said the website was user friendly, and many found it helpful to receive an online status of their prior authorization determination.
“Depending on the prescription, some medications require prior authorization before coverage, which, as of now, is a time-consuming process for all parties,” said Scott Greenwell, chief pharmacy officer of Humana Pharmacy Solutions, in the release, adding that prescriptions can now be approved and ready in real-time.
Well done, Humana!
Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? It’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? I believe it’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Small is the new Big means we must think differently about pharmacovigilance. While we must continue to capture adverse event data, we must also strive to capture Substandard Pharmaceutical Events (SPEs). SPEs occur when a product does not perform as expected—perhaps because of API or excipient issues. SPEs can arise because of an issue related to therapeutic interchangeability. When it comes to 21st-century pharmacovigilance, we have to both broaden and narrow our views about bioequivalence to the patient level.
The FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, CDER Director, Dr. Janet Woodcock said at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories. “We want to use leading indicators. These people aren’t in trouble yet but they could be.”
Per Peggy Hamburg, “All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.” Hamburg said the new office will “improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”
Congressional hearings are scheduled to hear from doctors, researchers and patient advocates Feb. 26 in a briefing on whether substandard generic drugs are reaching the U.S. medical system from overseas. The briefing will feature Harry Lever, a Cleveland Clinic cardiologist who has said generic drugs for heart failure made by India-based companies often don’t work the way they should.
The FDA is working with groups such as the Pharmaceutical Research and Manufacturers of America and American Association of Pharmaceutical Scientists to determine how often it will ask drugmakers to submit quality data.
Small is the new Big. That’s big news – and it’s about time.
A health care revolution threatened
“Personalized” medicines represent a health care revolution. Thanks to sophisticated and new diagnostic technologies, medical scientists have created hyper-targeted treatments keyed into the specific physiological traits of individual patients. These drugs are more effective than their conventional counterparts and less likely to cause adverse side effects. And they’ve proven valuable in the fight against diseases previously considered untreatable.
But drug developers need smart laws to flourish. Unfortunately, over just the last year, federal lawmakers have taken several steps that could smother pharmaceutical innovation and compromise private industry’s ability and willingness to pursue more lifesaving breakthroughs.
First, the good news. The market for personalized biopharmaceutical drugs is on track to double in size to $18 billion by 2019.
According to a recent industry survey from Tufts University, 94 percent of American biopharmaceutical companies are now investing in personalized treatments. Half of all drug prescription compounds now under development are personalized.
The sophisticated customization techniques deployed in the development of these treatments have proven particularly effective in the battle against “orphan” diseases – that is, illnesses afflicting fewer than 200,000 people.
There are 7,000 such diseases that affect more than 30 million Americans. In the 1970s, only 10 drugs were approved to treat orphan diseases. Today, there are more than 400, with an additional 450 are under development.
Most promisingly, federal authorities just approved the first drug ever to treat the underlying genetic flaw causing cystic fibrosis. Just a few decades ago, a child with cystic fibrosis was lucky to survive preschool. Today, the average patient lives well into their 40s.
These breakthroughs in personalized drugs are fundamentally changing how health care providers treat disease. But all that progress is now under acute threat from government.
For starters, Uncle Sam recently started up a “comparative effectiveness” research wing. This work is designed to determine if new, more expensive drugs are worth covering in programs like Medicare and Medicaid.
The fundamental flaw of comparative effectiveness research is that there is no such thing as an “average” patient. A treatment that might not make much of a difference for most patients could prove to be a life-saver for others.
If effectiveness research leads to more constrictive public insurance policies, enrollees that could benefit from advanced personalized drugs will be forced to pay for them on their own. Most simply can’t afford to do that. In effect, the government will be denying them access to this revolution in medicine.
Second, the government has created a new “academic detailing” program. It’s now sending its own representatives (usually local nurses) to doctors’ offices to provide an “academic” counterbalance to input from industry. Problem is, how and where these public representatives get their information is largely opaque. And, if a doctor treats publicly insured patients, these detailing officers have a perverse incentive to get her to choose less expensive drugs to save the program money. That’s not academic detailing – it’s government detailing.
Finally, the Federal Trade Commission is trying to micromanage the process by which new personalized medicines get named. This isn’t a minor issue. And approval delays could threaten the financial health of developers. They depend on sales to recoup their investment costs.
Drug developers will continue to make breakthrough, life-saving treatments as long as federal officials don’t needlessly intrude on their work. The year 2014 could be a banner year for drug development. But we need to get the policy right.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former associate commissioner of the U.S. Food and Drug Administration.
The Food and Drug Administration is studying whether disclosure limited only to serious side effects would improve consumer understanding, according to an agency document. To cover lesser side effects, the FDA proposed simply adding a line about “potential additional risks.”
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” the FDA said in its document.
The FDA plans to survey 1,500 study participants about ads with varying ranges of side-effect disclosure, and then measure their understanding of risk.
The underlying problem is that risk information is hidden in plain sight by not being in plain English. Risk information is neither designed nor delivered to be user-friendly. At present it is designed to be “in compliance.” And that has to change.
When it comes to DTC print ads, the joke inside the FDA (and in many regulated industry review offices) is that the Brief Summary is like the Holy Roman Empire – it is neither brief nor a summary. So, when it comes to TV ads, hopefully the agency is asking the right questions. Fair Balance and Adequate? “Fair” for whom and “Balanced” how? Adaquate Provision? Doesn'tlook like it.
Working together, the FDA and industry can make a difference. DTC can be a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because an educated consumer is not only a better customer, but a more compliant and adherent patient.
FDA Commissioner Peggy Hamburg visits India and confirms that honesty is the best policy. The feeling is not entirely reciprocated.
It boils down to a simple, foundational question: Can there be more than one global standard of pharmaceutical quality?
“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.”
Does that mean US standards are too high or that Indian ones are too low? Well, where you stand depends on where you sit. And if you’re sober and sitting up straight, the answer is obvious.
According to a May 2012 article in The Lancet,
“To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.”
The CDSCO has a staff of 323, about 2 percent the size of the FDA, and its authority is limited to new drugs. According to a report in the New York Times, “The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India’s top drug regulator, warned in meetings with the FDA of the risk of overregulation.”
Hardly.
Per the Times, “This absence of oversight, however, is a central reason India’s pharmaceutical industry has been so profitable. Drug manufacturers estimate that routine F.D.A. inspections add about 25 percent to overall costs. In the wake of the 2012 law that requires the F.D.A. for the first time to equalize oversight of domestic and foreign plants, India’s cost advantage could shrink significantly.”
This profits-over-patients philosophy is entirely consistent with earlier “passing the rupee” comments of India’s Deputy Drug Controller, S. Eshwar Reddy.
When asked if Indian manufacturers -- which produce more than 40 per cent of the API used in the US and Europe -- should be more sympathetic with Western guidelines and regulations, Reddy said the opposite should be true.
He said any additional requirements made are the sole responsibility of the authority that issues them.
“If the importing country has specific GMP requirements, that is their responsibility to audit the facilities. It is the responsibility of the importing country not the exporting country.”
Per the Times, “The unease culminated Tuesday when a top executive at Ranbaxy — which has repeatedly been caught lying to the F.D.A. and found to have conditions such as flies “too numerous to count” in critical plant areas — pleaded with Dr. Hamburg at a private meeting with other drug executives to allow his products into the United States so that the company could more easily pay for fixes. She politely declined.”
How do you say chutzpah in Hindi?
Or Chinese? Or Arabic? Or Russian? Or Zulu?
New research conducted by CVS Caremark and Brigham and Women's Hospital (and published online in Health Affairs) identifies five key features of popular Value-Based Insurance Design (VBID) plans that are associated with the greatest impact on medication adherence. The study, which will also appear in the journal's March issue, was funded by a grant from the Robert Wood Johnson Foundation's Changes in Health Care Financing and Organization (HCFO) Initiative.
The philosophy is sound – but the factors are a bit fuzzy. And this isn’t surprising as the VBID model is still in in its design infancy.
Rather than encouraging patients to actively consider and bear the cost of prescription medications via copayments, co-insurance and deductibles, VBID plans reduce the cost to the patient for medications that offer higher clinical benefit.
The theory is that using medication that actually improves health outcomes will reduce overall health care spending. Correct! For example, patients in a VBID plan who have a chronic disease such as high blood pressure would have their out-of-pocket costs (e.g., copay) significantly reduced or eliminated for essential medications to treat their condition.
This is important – but it’s not new. As I wrote almost exactly four years ago in an op-ed:
Over the past several years, insurance companies have become increasingly reluctant to foot the bill for brand-name medications. Indeed, since 2000, co-pays have increased four times faster than prescription drug prices.
Patients respond to higher co-pays by skipping their meds more often. In 2003, researchers at the University of Oregon studied the effects of introducing a $2 to $3 co-pay for prescription meds among 17,000 patients. Adherence to treatment dropped by 17 percent.
Some insurers are even refusing to cover new prescription drugs. According to a study from Wolter Kluwer Health, insurers’ denial rate for brand-name meds was 10.8 percent at the end of 2008 — a 21 percent jump from the year before.
Abandoning treatment — a practice known as "non-adherence” — has serious consequences for patient health. For instance, people with hypertension who neglect their meds are more than five times more likely to experience a poor clinical outcome than those who don’t. Heart disease patients are 1.5 times more likely.
It also results in higher medical costs, as patients who go off their meds often end up in the hospital. Minor conditions that might have been controlled by inexpensive medications can sometimes balloon into life-threatening illnesses that require surgery or other costly treatments.
This makes sense. After all, a daily cholesterol-lowering drug is far less expensive than emergency heart surgery.
(My complete op-ed can be found here.)
Now, as to the “factors.”
According to Niteesh Choudhry, MD, PhD, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and associate professor, Harvard Medical School and the lead author of the study, "The results show that several specific features can improve adherence from between two to five percentage points and this information can help influence how future copayment reduction plans are structured for optimal benefit."
The researchers evaluated 76 VBID plans provided by CVS Caremark to 33 unique plan sponsors and involving more than 274,000 patients. Based on the analysis, five key features were found to have a greater impact on adherence. These included:
- More generous VBID plans (e.g., those plans that had no cost-sharing for generic drugs and low monthly copayments of < or = $10 or co-insurance rates of < or = $15 for brand-name medications),
- Plans that targeted high-risk patients,
- Plans that had concurrent wellness programs,
- Plans that did not have concurrent disease management programs, and
- Plans that made the benefit available only by mail order, offering 90 day prescriptions.
That’s a lot of work by a lot of smart folks to develop some pretty fuzzy factors. But it’s a good start.
As for the future, your task is not to foresee it, but to enable it.
-- Antoine de Saint-Exupery
Conflict of Interest (COI)? Only for thee but not for PCORI.
From the pages of Current Medicine:
Industry conflicts arise at PCORI threatening any real comparative effectiveness research
The Patient Centered Outcome Research Institute (PCORI) was created by the PPACA “ObamaCare” law in 2010. Well-funded with approximately $3 Billion over ten years, the mission was, among other things, supposed to be to conduct comparative effectiveness research (CER) that would determine whether costly therapies are any better than cheaper alternatives.
The rise of CER has been one of the most feared developments by the drug and device industries. To avoid powerful lobbying efforts that could have resulted in de-funding and the death of PCORI before it got started, the institute steered away from even hinting at conducting CER. Now, almost four years later, PCORI is finally funding CER research. However, critics, such as former White House Director of Office of Management and Budget, Peter Orzag, say that the money spent by PCORI on CER is still not enough.
Meanwhile, a leading doctor in charge of PCORI research strategies, Harlan Krumholz, MD, a cardiologist at Yale, helped create The Yale University Open Data Access project, or “YODA”, and is the Principal Investigator. The YODA mission is to make clinical trial data more open and accessible to researchers.
Medtronic was one of the first corporations to pay YODA to analyze clinical data on the spine fusion growth factor product called InFuse. Recently, Johnson and Johnson (JNJ) signed up as the next large corporate client of YODA.
The drug and device industries have long been adept at muting the regulatory influences of healthcare agencies, such as the FDA, AHRQ, and CMS, using a variety of tactics. The “golden revolving door” hires former government regulators into lucrative jobs at JNJ, etc. Also, academic medical center “institutes” designed to keep the industry honest then become corrupted by accepting industry funding.
Since Dr. Krumholz is the senior clinical decisionmaker for both the Yale YODA, and the ObamaCare-created PCORI, conflicts of interest would arise if the industry began funding YODA. For examples, PCORI could be conducting CER on the various hip implant products and conclude that the JNJ DePuy device is no better than a less costly hip implant, or a Medtronic coronary stent might be found by PCORI research to be harmful and ineffective. But if Medtronic and JNJ began to pay millions of dollars to Yale’s YODA, then Dr. Krumholz would have a significant biasing force against initiating any CER at his other job, PCORI, that might harm sales of JNJ or Medtronic products.
In a brief interview with Dr. Krumholz about how he is managing these conflicts of interest, he replied, “Right – (there is) no direct connection (between YODA and PCORI research)– just a potential COI. All I can say is that it is disclosed. And I note that PCORI has people with different relationships. And that most of what PCORI does is in public view so people can assess for themselves.”.
Dr. Krumholz is correct in pointing out that many other members of the PCORI executive team and board have reported conflicts of interest accepting financial support from drug and device companies. We will have more on that in future reports.
The Executive Director of PCORI, Joe Selby, MD PhD, did not reply to our emails in time for this publication.
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.
