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OTC Statins: More Questions than Answers
Much news lately about Pfizer’s desire to move Lipitor into the OTC category.
OTC statins. Not a new conversation, but certainly a timely one as we continue to face not just Hyperlipidemia – but medication adherence (and particularly for chronic, asymptomatic conditions).
Are statins “safe enough” to be available without a prescription? Well, with the appropriate caveat that no drug is 100% safe, it’s pretty fair to say that their safety profile is excellent – for Rx products. But is the same true if they were available OTC?
Here’s some history.
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell lovastatin (Mevacor), without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase lovastatin from pharmacists much like the British are allowed to purchase simvastatin (Zocor), another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
(Other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.)
Then, in 2007, another proposal to offer lovastatin over-the-counter was rejected by an FDA panel, primarily due to the fear consumers might not select the drug appropriately.
“It is not clear that the benefits to patients of lovastatin being over-the-counter outweigh the risks, although the risks are small,” Arthur Flatau, PhD, said during a joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee. “Clearly, there are a lot people who are not on statins and should be on statins; putting the drug over the counter will not increase the number of patients who take it.”
The vote was 10-2 against over the counter approval of lovastatin with one abstention. The majority of panel members who voted against lovastatin over the counter felt consumers were unable to make a decision regarding whether they should be taking a statin.
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Per a New England Journal of Medicine written by the chair of the FDA advisory committee, "Some docs argue that increasing access to statins could prevent heart attacks and strokes, which in turn would lower health care costs. Overall, a study of an OTC Mevacor (Merck's statin) showed 30 percent of patients who thought they should take the drug actually had less than a 5 percent risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit."
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
Pfizer recently started a 1,200-patient clinical trial to test if consumers taking OTC Lipitor and getting their own blood tests improve their cholesterol levels and then make the right decisions based on the results of a second blood test. (These blood tests, in the real world, would be administered at the pharmacy.)
What additional questions should be asked when it comes to the OTC statin debate? Here are a few:
* Should any chronic medications be available OTC? (This is a very big “beyond statins” question that hasn’t been widely discussed … yet.) Most Rx-to-OTC switches have been for the treatment of acute, transient symptoms of allergies, heartburn, etc.
* Isn’t this a de facto BTC play? After all, the pharmacist will have to advise, test, and dispense. Isn’t that beyond the scope of FDA’s existing regulatory authority?
* Is an OTC “Drug Facts” label up to the task of properly communicating the most important benefit/risk information about statins (or, for that matter, about any OTC product)?
* Even at a 10mg dose?
* Per that second blood test, what does “success” look like?
* What if the patient doesn’t come back for a second blood test?
* What about the financial burden on the consumer? Rx products are reimbursed. OTC products are not.
* And, to that point, when there is an increased financial burden on the patient (i.e., raised co-pays) – adherence declines. Would OTC statins further exacerbate the problems with statin adherence?
* If, after the second pharmacist-implemented blood test, the patient is told to see their physician – why shouldn’t they just have gone to see their physician in the first place?
* If Pfizer is granted the OTC designation for Lipitor and then other statins follow suit (a pretty safe supposition), how are patients supposed to choose which statin is “best for them” minus a physician's “clinical experience?”
* What about prospective patient (aka “consumer”) education? Pfizer says it hopes to persuade regulators to approve OTC Lipitor by using "new and creative ways" to communicate instructions for use.
All this to say that it’ll make for an interesting and important conversation.Read More & Comment...
The visionary lies to himself, the liar only to others. -- Friedrich Nietzsche
You can fool some of the people all of the time and all of the people some of the time. But what about when it comes to election time?
The Big Lie of ObamaCare is “If you like you’re insurance you can keep it.” And it’s the lie that keeps on giving.
Here’s the latest from the pages of Modern Healthcare – a magazine without an agenda that plays it straight.
Extension of policies that don't comply with ACA called ploy
The Obama administration's decision Wednesday to allow people to keep insurance plans that don't comply with the Patient Protection and Affordable Care Act for an additional two years was quickly criticized by ACA opponents as a midterm-election-year ploy, even as administration officials were denying politics was involved in the decision.
Regardless of the motivation, the change likely will irk insurers hoping to sign up as broad a spectrum of the public, especially healthy people, as possible in compliant plans offered on exchanges.
“Plans need to know the parameters in which they have to work so they can make the best decisions for the consumers they serve moving forward,” said Jeff Drozda, CEO of the Louisiana Association of Health Plans, which counts both large payers and small regional plans as its members.
Last month, during an earnings call, Humana expressed disappointment in the number of enrollees it had from the exchanges at that point and blamed the company's woes on the transitional policy, for example.
“We believe this change will result in an overall deterioration of the risk pool and ACA-compliant plans as more previously underwritten members have stayed with their current carriers rather than enter the exchanges,” Humana President and CEO Bruce Broussard said.
Administration officials Wednesday, confirming media reports that started surfacing early this week, announced insurers could renew noncompliant policies that begin on or before Oct. 1, 2016. That means some customers can stay on these plans into 2017.
This is an extension of a decision made in November when the president gave states the ability to allow noncompliant policies to continue. Originally these plans were only meant to last until October 2014, right before midterm elections in November.
High-ranking administration officials who spoke on background to reporters Wednesday insisted multiple times that the potential backlash of thousands of people receiving policy cancellation notices right before heading to the polls played no part to the extension.
Instead, they said, the extension gives 500,000 consumers in these plans time to make the choice of staying in their current policy a little longer or joining a new marketplace plan. They added that it's likely all of these consumers will make the switch to a compliant plan by 2016, but if they do not, HHS now has the discretion to extend the transitional policy for a third year.
The more than 20 states that chose not to allow consumers to keep noncompliant plans will now have another opportunity to do so as long as the plans are still active, they said. People now in compliant plans can't go back to ones that don't meet the standards.
Beyond any administration concern about midterm elections, concern about the tax penalty these individuals were facing likely also played a role in the decision, said one ACA observer. Before the new extension, if a person didn't have a compliant ACA plan by the end of the enrollment period in 2015, he or she would have been hit with a levy worth up to 2% of income when filing taxes in 2016.
“Without the extension, a lot of people may get hit with the tax penalty and that could lead to a political fallout,” said Ning Liang, co-founder of a new website that helps people compare and sign up for ACA-compliant plans on HealthCare.gov.
The change is likely to provide scant political cover to Democratic congressional candidates facing broad attacks over the administration's healthcare policy, some said.
“I think, at this point, consumers have wised up and are asking some demanding questions,” said Peter Pitts, president of the Center for Medicine in the Public Interest. “This extension further demonstrates the disingenuous nature in how certain political candidates are presenting the Affordable Care Act to their constituents”
“The problem is you can't unshoot the gun,” said David Hogberg, a healthcare policy analyst at the National Center for Public Policy Research. “People are going to remember that the administration violated a very serious promise that people could keep their plans and I suspect Republicans will use that to no end this November.”
The extension gives Republicans one more change to the Affordable Care Act to criticize. Grace-Marie Turner, president of the Galen Institute, a conservative research organization, noted that her organization has tracked at least 19 changes made, most by executive order, to the ACA since it became law.
California Assemblywoman Susan A. Bonilla has partnered with the California Pharmacists Association and the California Healthcare Institute to introduce legislation (AB 2418) that improves the process for medical patients to obtain their prescription drugs and follow their doctor's instructions on taking their medications.
"Poor medication adherence costs the US health system $290 billion dollars in other health care expenditures, such as emergency room visits and unnecessary physician office visits," said Jon Roth, Chief Executive Officer for the California Pharmacists Association. "Assembly member Bonilla's legislation will go a long way to improving medication adherence by allowing patients to receive their medication in a way that is most convenient to them and all those medications to be synchronized with all their other drugs, resulting in the best chance for a patient to successfully complete all of their prescriptions."
Specifically, this bill:
* Allows patients to opt out of their health plan’s mandatory mail order program if they prefer to obtain their prescription drugs from a community pharmacy.
* Streamlines prescription medications by placing the patient’s medications on the same refill schedule.
* Allows patients who run out of prescription eye medications because of accidental spillage or who use more than 70% of their eye drops to be eligible for an early refill.
Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association
By creating processes that support and improve patient access to medications; patients experience better health outcomes and improved quality of life. Patients who pick up their medications at their local pharmacy have the opportunity to talk with their pharmacist about how to properly take their medications and to understand the positive benefits of taking their medications.Read More & Comment...
The launch of Human Longevity Inc., by Craig Venter, Bob Hariri and Peter Diamandis is predicated on the assumption that the only way to get enough people take enough risk for such undertakings is to create a commercial enterprise. Calico (the Google anti-aging venture) and HLI are examples of how private companies and capital markets can achieve what governments and anti-capitalist types can only talk about.
Recently, a news account implied that there was something wrong in the CEO of Gilead being worth over a $ billion. As if somehow someone who invested 20 years and billions in developing treatments that are effectively cures for AIDS and Hep C should be not be rewarded. We celebrate the Forbes 400 Richest People in the world for their billions and their charity but not the people who lead firms that make longer life possible for billions.
Yes, many new medicines have retail prices that make one gasp. Cancer drugs that cost $90K and Hep C drugs that ring in at $84 K. They could be cheaper but that would require cutting the amount of time and money needed to pass through the FDA. (By comparison, average cost of private four year college is $160K) Setting aside that on average the sticker price is about 20-50 higher than actual charges these new medicines displace more expensive and less effective treatment and allow people to lead healthier, longer lives.
These new treatments are a bargain. We forget that while medicines may be pricey, disease is always much more costly. Unfortunately, under Obamacare health plans are sticking more people with a bigger share of the cost. This moved is designed to discourage use by the people in greatest need and direct outrage away from insurers to drug companies, their executives and their net worth. That's bad policy and immoral to boot.
Some want to tie higher executive compensation to lower prices of medicines. Apart from the bureaucratic nightmare such a system would require, that would mean eliminating the connection between return on investment and the value of innovation. Would anyone think of requiring that the compensation of Steve Jobs or Elon Musk should increase only if they make cheaper products? All such proposals do is drive the capital, risk taking and profits into other industries like apps, entertainment and fashion.
In announcing the launch of HLI Craig Venter noted: “This is a very expensive undertaking. The only way to do that is to make it so the data is so meaningful that it has commercial value,” Dr. Venter said. “If it doesn’t, then this will be a very short-lived phenomenon.”
Translation: if we don't reward risk taking on behalf of human health, both will shrink. Killing rewards for medical innovation kills people.
Read More & Comment...
Senator Charles Schumer is urging Health and Human Services Secretary Kathleen Sebelius “to overturn the government’s approval of a new powerful prescription opioid, Zohydro ER” (hydrocodone), “until it has been made abuse-proof.” According to reports, Schumer “believed there was a ‘decent chance’ that” Sebelius would revoke the FDA approval.
Whatever your position on the issue of opiods, the proper venue for this decision is not the office of the Secretary of HHS but rather the office of the FDA Commissioner.
And Senator Schumer should know better.
Chuck, can you say, "Plan B?
From the good folks at policymed.com …
A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature doesn't conform to the product's FDA-approved uses. FDA's guidance forms a checklist of sorts that companies will need to check against each instance of literature they wish to promote.
FDA's new draft guidance document, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, is meant to provide life science companies with a checklist for making sure they stay within the acceptable limits of promotion of scientific and medical publications. The guidance is a revision of a 2009 draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. As noted by Regulatory Focus, that guidance came under fire from life science companies, which argued that it restricted their ability to "promote the public health" by distributing scientific information informing the safe and effective use of their products.
In an accompanying statement, the FDA stated that it's currently working on additional guidance on scientific exchange, responding to unsolicited requests for off label information, and interactions with formulary committees.
This draft guidance shows that the agency is getting the message that it must conform its policies and practices to the First Amendment," said Coalition for Healthcare Communication Executive Director John Kamp in a released statement. "Manufacturers should be able to distribute truthful information – in the form of journal articles, medical textbooks and practice guidelines."
In an Industry Leaders Alert, Kamp also stated: "These actions, combined with recent guidance on social media and a new study on the effectiveness of current warnings on TV commercials, suggest that the FDA is serious on updating critical marketing policies, perhaps in recognition of the First Amendment challenges it faces is defending current policy."
"While these are small steps forward, they are significant nonetheless and will enable more reasonable communication between regulated companies and medical professionals, leading to more efficient and effective patient care. The new draft guidance also supports our case with CMS that journal reprints and reference textbooks should be exempt from reporting under the Sunshine Act."Read More & Comment...
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!Read More & Comment...
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.Read More & Comment...
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.
Read More & Comment...
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! Read More & Comment...
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.Read More & Comment...
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.Read More & Comment...
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.Read More & Comment...
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.”
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?Read More & Comment...
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:
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. Read More & Comment...
Think governments can set prices and interfere in markets with no consequences? Think again.
According to a just released analysis by the United States Government Accountability Office, the FDA is doing a better job preventing drug shortages.
Per CDER Deputy Director, Doug Throckmorton’s Congressional testimony, new shortages declined in 2012 for the first time in a number of years and 2013 data indicated a similar downward trend. He said the agency’s new authorities (granted under a 2012 law) have allowed the FDA to manage shortages more aggressively.
In addition to new actions, the FDA has been more willing to demonstrate regulatory flexibility.
For example, in some cases where particles were found to be contaminating a drug that was in short supply, the agency allowed the company to filter the drug to avoid disrupting supplies instead of shutting down the production line altogether.
But, according to the New York Times,
Economic factors are also a contributing factor. Narrow profit margins are making some drug companies reluctant to invest in fixing old production facilities. Changes in Medicare reimbursement and the role of group purchasing organizations, which buy drugs on behalf of hospitals, could also be contributing, by further reducing prices that producers get for the drugs.
(This is almost a direct citation from the June 2012 Center for Medicine in the Public Interest, "Fixing Drug Shortages.")
While the FDA’s new authorities are both timely and important, there are many pieces to the drug shortages problem – not the least of which is that (when it comes to hospital injectables) 30% of manufacturing capacity is off-line due to FDA inspection issues.
That’s a lot of capacity. In fact, according to the agency, 43% of reported potential shortages were due to manufacturing problems. Safety is non-negotiable and alleviating a shortage by shorting GMPs is a bad and dangerous pathway. Expediency causes as many problems as it solves.
That being said, regulatory discretion must be part of the solution – and per Throckmorton, it is. With 30% of production capacity off-line because of FDA issues, the agency must continue to work with manufacturers to find creative, science-based solutions. If you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.
But who inspects the inspectors? Per that 30% of manufacturing capacity off-line due to FDA issues, perhaps the FDA should undertake an agency audit to see why there’s been such a jump in GMP issues. It’s hard to believe that year-over-year, production quality control has suffered such a significant lapse. Is there something wrong in the way FDA inspectors (many of them still wet behind the ears and eager to please) are doing their jobs? It’s a question worth asking – and answering.
But the real headline (alluded to but not directly addressed in the New York Times article) is that artificially low prices are the major cause drug shortages.
Most of the drug shortages that occur in the U.S. arise in the generics market, where profitability is fairly low For many of these drugs the market can only sustain a handful of manufacturers -- sometimes just one or two. So, when supply disruptions occur -- caused by manufacturing violations, production delays, shipping problems or ingredient issues -- there aren't a lot (or in many cases any) additional producers in the market to pick up the slack.
But the key factors behind drug shortages are perverse economic incentives. Consider the October 2011report by the US Department of Health & Human Services, Economic Analysis of the Causes of Drug Shortages.
HHS (the Obama HHS) mostly blames a dysfunctional marketplace for drug shortages. In fact the HHS report does more than blame a 'dysfunctional market', it explains what is behind the problem:
"...drugs that subsequently experienced a shortage are those in which the volume of sales was declining in the 2006-2008 period prior to the shortages."
It goes on to note that, "Analysis of average sales prices shows that shows that oncology sterile injectable drugs that experienced shortages since 2008 decreased in price from $56.17 per unit in Q1 2006 to $37.88 per unit in Q1 2011. Oncology sterile injectable drugs that have not experienced shortages have had relatively stable prices over this period."
In plain English: artificially low prices caused the manufacturing decline of the drugs that are in shortage and a variety of perverse government regulations (ranging from Medicaid reimbursement rates to the benighted 340B program) are causational.
Where there is still a profit left, you rarely see shortages.
Congrats to the FDA for a job well begun. But the issue of drug shortages (and particularly the economic issues that must be addressed) mustn’t be left half done.Read More & Comment...
Excellent cover story in today’s edition of BioCentury on the February 4th FTC hearing on competitiveness issues surrounding biosimilars.
Steve Usdin calls it like he sees it – and he sees it pretty clearly.
Agendas. Agendas. Agendas.
The headline reads, Biosimilar schism.
Some choice quotes:
For years, innovator biologics manufacturers battled companies that wanted to create an American biosimilars industry, skirmishing over the scientific and legal standards for demonstrating similarity.
Now, however, the biggest conflicts are among biosimilars developers. The growing ranks of biosimilars developers and manufacturers have split roughly into two camps. One is pursuing a business model based on branded biosimilars that will require substantial investment in marketing and sales, and the other is hoping to create interchangeable biologics that could be substituted for innovator products with little or no marketing.
While supporters of the principles for state substitution laws portray them as applying equally to innovator and interchangeable products, that view was rebuffed by companies advocating for a biosimilars market that would allow them to avoid marketing costs and compete primarily on cost.
Bruce Leicher, SVP and general counsel at Momenta Pharmaceuticals Inc., told FTC that the substitution principles are an effort to ask “states to join in a commercial marketing campaign to disparage interchangeable biologics.”
Notification requirements would “restrict substitution and provide notice to doctors to intervene and be concerned about FDA approved biologics,” he said. Leicher accused supporters of the state legislation proposal of attempting to blur the distinction between biosimilars and interchangeable biologics. “The notification provisions are really designed to make the point that interchangeable biologics really aren’t interchangeable, they’re different,” he said.
What Leicher doesn’t seem to understand (or what he understands but wants to purposely obfuscate) is that interchangeable biologics are different from their innovator priogenitors – but bioequivalent enough to be therapeutically interchangeable (as per the FDA).
That's not a "scare tactic," that’s just a fact. Another fact is there can be more than one winner – the most important being the patient. The FTC hearing often sounded like the Biosimilar Hunger Games.
Here’s a link to Usdin’s complete Biosimilar schism.
For more on the FTC hearing, see The Sic et Non of Biosimilars and be sure to tune in to BioCentury This Week, where Usdin will interview with Geoff Eich, Amgen’s Executive Director of R&D Policy and Craig Wheeler, CEO of Momenta. The show will be broadcast and available on the web on SundayRead More & Comment...
Dr. Michael Weber, Chairman of the Center for Medicine in the Public Interest (among other appointments), is the chief author of new guidelines for the treatment of hypertension, perhaps the most common life-threatening risk factor around the World. The guideline is an official statement of the American Society of Hypertension and the International Society of Hypertension.
Dr. Rick Turner, senior fellow at CMPI (the least of his many accomplishments), has penned (along with Philip Galtry is Vice President and Cardiovascular Therapeutic Strategy Head, Cardiovascular and Metabolic Therapeutic Delivery Unit, Quintiles) a primer to the ASH/ISH guidelines. It appears in the current issue of the Journal for Clinical Studies.
Turner and Galtry’s commentary can be found here.
The ASH/ISH guidelines can be found here.
The Center for Medicine in the Public Interest has heart and is in the heart of the battle for better, more personalized CVD diagnosis and treatment, and outcomes.Read More & Comment...
Representative Rosa DeLauro once again demonstrates her ignorance.
According to a press release, “Congresswoman Rosa DeLauro (D-CT) today outlined her concerns over accelerated drug approval in a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg. She also asked Hamburg for details on device safety to ensure that women and families can rely on safe and effective drugs and medical devices that improve health and wellness. DeLauro is a former chairwoman of the subcommittee responsible for funding the FDA.”
Didn’t she vote for PDUFA V, which put into place many of the accelerated approval pathways she is now criticizing?
If Representative DeLauro believes no drug should be introduced into the marketplace until it is completely understood then there would be no drugs in the marketplace. When it comes to serious and life-threatening diseases, that is nothing short of a death sentence for tens of thousands of Americans.
It should also be noted that patient groups tend to be the most ardent supporters of the accelerated approval pathways and patients with more dangerous diseases are more willing to accept taking treatments that may have higher risks
The good news is that Peggy Hamburg once again demonstrates both her knowledge and her ability to share it in a politically palatable manner.
Why FDA Supports a Flexible Approach to Drug Development
By: Margaret A. Hamburg, M.D.
We all know that just as every person is different, so too is every disease and every drug.
so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association. The study found that FDA used a range of clinical trial evidence when approving 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012. These results are entirely consistent with our regulatory mandate. We believe varying approaches to clinical studies to support drug approval is good news, not bad.
Data to support the approvals studied were based on a median of two pivotal trials per indication. A pivotal trial presents the most important data used by FDA to decide whether to approve a drug.
But when the authors looked more closely, they found that more than a third of these drugs were approved on the basis of a single pivotal clinical trial, while still other trials involved only small groups of patients for shorter durations. Of the approvals studied, the new drug was compared with existing drugs on the market only about 40 percent of the time.
The authors concluded that, based on these results, the ways in which FDA arrived at those approvals “vary widely in their thoroughness.” Or, in the words of one study author, “Not all FDA approvals are created equally.” Although I don’t think it was actually the author’s intent, a number of commentators framed this as criticism. But I would be more troubled if FDA used a rigid, “one size fits all” approach.
People with serious or life-threatening illnesses, particularly those who lack good alternatives, have told us repeatedly that they are willing to make some trade-offs in order to gain access.
And, of course, “thoroughness,” such as whether a clinical trial is large enough, is in the eyes of the beholder. There is no reason to expect drugs to be tested on similar numbers of patients, regardless of the disease.
Variation in approach to clinical studies demonstrates FDA’s innovative and flexible approach to drug development and approvals. Such an approach was specifically adopted by Congress in the Food and Drug Administration Modernization Act in 1997 and, most recently, in the Food and Drug Administration Safety and Innovation Act in 2012.
The FDA of today works with sponsors of new drugs to design a development and review pathway for each drug that best reflects the disease and patients it is intended to treat, the drug itself, and other treatment options. Some of the factors that enter into our calculus include whether the drug treats a rare or serious disease or addresses an unmet need and any previous knowledge we might have about the drug.
Thus, for example, FDA approved Imbruvica (ibrutinib), a treatment for mantle cell lymphoma, last year based on an “open-label, single-arm trial,” which means that every patient received the treatment and both patients and researchers knew they were receiving it. The results were compared to how well the 111 participating patients had responded to previous treatment for their disease.
And Elelyso (taliglucerase alfa) – for Gaucher disease – was an orphan drug approved in 2012 based on two trials with 56 patients.
In contrast, some trials require large numbers of patients to demonstrate a drug’s effects. This is often the case in studies in patients with a chronic condition such as cardiovascular disease, where larger populations are studied to capture treatment effects.
No matter what clinical trial design is chosen, the Agency always applies the same statutory approval standards of safety and efficacy to all drugs seeking to be marketed in the United States.
Increased flexibility does not mean abandoning standards, and it certainly does not mean abandoning science. Just the opposite. We need to employ the best science in ways that will increase efficiency, productivity and our shared ability to find creative solutions to the challenges that confront us.
At the end of the day, that is just smart regulation – ensuring that patients can more rapidly have access to the best that science has to offer.
Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug AdministrationRead More & Comment...