Latest Drugwonks' Blog
From The New York Post
An ugly way to get insurance
By ROBERT GOLDBERG
Last Updated: 11:23 PM, September 19, 2012
Posted: 11:10 PM, September 19, 2012
The good news: More Americans have health insurance. The bad news: It’s because they don’t have jobs.
ObamaCare supporters hail the drop in the number of uninsured, announced by the Census Bureau last week, as a sign of the new law’s success. In fact, it’s a sign of continued job-market decline and of how many of us have to depend on government programs for far too long.
Nearly 1.4 million more people had health insurance in 2011 than in 2010 — but that includes nearly 800,000 who gained coverage despite not working at all.
In short, the rise comes mainly from more Americans being forced into safety-net programs by declining incomes and reduced job opportunities.
Look at this trend another way: In 2011, the number of people covered by Medicaid jumped 2.3 million, while Medicare saw 2 million new enrollees.
And only 575,000 of those new Medicare cases were people turning 65. Most of the other 1.5 million is associated with the exponential growth in people becoming Medicare-eligible because they’ve filed for Social Security disability coverage.
By comparison, the number of people gaining health insurance via work rose only 730,000.
ObamaCare fans also claim that much of the increase in coverage came from the Obama law’s mandate that young adults can stay on their parents’ health plans until they turn 25.
Indeed, the administration boasted earlier this year that 3 million young adults got insurance that way. But the Census Bureau report shows that health coverage for people in that age bracket rose by only 540,000.
And it’s clear that ObamaCare was not responsible for much of even that increase. Past Census reports show the share of 19- to 25- year-olds on Medicaid or Medicare doubling from 2000 to 2011. That long-term trend — not the ObamaCare mandate — plainly accounts for a good chunk of the rise in coverage of these younger folks.
Slice it another way. The total increase in health coverage for ages 18-24 in 2011 was 825,000. Nearly 331,000 of that was from employer-based coverage. More than 220,000 was from Medicaid enrollment.
So, at most, that’s 247,000 from ObamaCare’s under-25 mandate.
And that gain comes at a hard-to-measure cost: The price of forcing insurers to cover under-25s on their parents’ policies is higher premiums for other people.
Let’s be clear: Medicaid, the Children’s Health Insurance Program and Medicare make health insurance affordable for tens of million of Americans. But that safety net, in place before ObamaCare was enacted, is supposed to be a temporary source of support when we need it, not a permanent solution.
And a jump in the number of Americans who have to use that safety net is nothing to brag about.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest.
http://www.nypost.com/p/news/opinion/opedcolumnists/an_ugly_way_to_get_insurance_etNZJPm74YKgP0euAZJWSM#ixzz271N2B2m9
Drugs elude cookie-cutter approval process
A powerhouse mix of pharmaceutical companies including Abbott, AstraZeneca, Boehringer Ingelheim and Bristol-Myers Squibb has launched a non-profit tasked with making it easier for companies to bring news drugs to market.
The initiative, called TransCelerate BioPharma, is headed up by J&J alum Garry Neil. Its first project focuses on clinical trial execution and will include creating an investigator site, developing clinical data standards and establishing a comparator drug supply model, according to a statement. More tangible details were not forthcoming, other than the comment that the goal is to help speed drugs to market, but the news release quoted FDA Director Janet Woodcock as saying the collaboration “has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry.”
In other words, it appears to be a project that tries to pin down the very thing that has roiled industry watchers when it comes to the FDA's review process: predictability and its seeming absence. Yet experts have told MM&M in the past that uniform standards won't create an if-then scenario in which the FDA will approve drugs based on meeting the demands of a checklist.
“Predictability assumes that you can approve drugs in a cookie-cutter kind of fashion and you just can't do that,” Dr. Steven Nissen, a frequent member of FDA advisory panels and chairman of the Cleveland Clinic's cardiology department, told MM&M. “It's always going to be a nuanced decision. It's always going to be a careful evaluation of benefit vs. risks,” he added.
The agency has come under a mixed review, with critics saying the FDA is approving drugs without adequately considering a drug's risks. Advocacy group Public Citizen is suing the agency over its approval of the Alzheimer's drug Aricept 23, an approval which its deputy director of the Health Research Group Michael A. Carome told MM&M was made even though the agency acknowledged that the drug didn't meet the standards the regulators demanded even before it came up for review. The drug, at a higher dose of the 5- and 10-mg versions which have gone generic, has been linked to nausea, vomiting and dizziness, but with little benefit, according to Carome and other critics.
“This represents an extreme example of the FDA's failure to properly weigh the evidence and only approve drugs when there's clear evidence [that] benefit outweighs the risk,” Carome said.
Nissen, who was not part of the Aricept 23 review and does not specialize in Alzheimer's, said that the risk-benefit equation had a degree of flex that depends on who's doing the calculation.
“I think the most salient example is cancer drugs. You're dealing with a disorder with often a lethal disorder. These drugs that are used to treat cancer are pretty toxic, but the disease is a pretty lethal disease,” he said.
Former FDA Associate Commissioner Peter Pitts said the FDA gets knocked in part because it doesn't do a very good job at explaining how the drug review and approval process works.
Among the steps is a clinical trial design that the FDA approves before it's kicked off. Pitts noted that hitting all the right design notes doesn't guarantee a panel's endorsement if the results raise questions.
“Those questions need to be answered.” Pitts highlighted two other components of the FDA's decision-making process which includes basing its decisions on “the twin pillars of safety and efficacy,” a balance he said is important because “you can't look at safety independent of benefit.” He also noted that the committees are comprised of experts that see data differently, which can add nuance to discussions.
But nuance or heated argument doesn't always mean pushback. The May debate over the blood thinner Xarelto was a contentious committee hearing, in which panelists took serious issue with the quality of the data presented. The drug passed with a panel endorsement despite the attacks on missing patients and an inability to state just how many patients may have died during the clinical trials.
Adding to the fuzziness is that what constitutes acceptable risk is also subject to change. Recent examples: weight-loss drugs Qsymia and Belviq which failed to clear the FDA the first time they were up to review, which was before the CDC declared obesity an epidemic.
Pitts said one way to provide continuity would be to use the same requirements for drugs that have the same purpose and said that this industry push is not about lower standards, but about making smart investments. He said ambiguity in that regard is "not fair and that's not good science." He said it could also help within the wider context of creating a single standard that can be used for both international and domestic regulatory review.
Such a change will not remove risk, and both Pitts and Nissen said results can't simply be accepted because panelists didn't know what to ask before results roll in. Even when a clinical trial meets expectations and has the FDA's go-ahead, Nissen noted that new risks are bound to surface because clinical trials are little more than real-world approximations. “You have done a series of studies with a drug in a few thousand people and the drug may be used in a million . . . there is no way to be absolutely certain whether a drug is going to be helpful or harmful,” he explained.
Nissen said he understands the drug industry's frustration with the case-by-case approach, but he said it can't be avoided. “It's about their investment and their bottom line and I completely understand that but the FDA has a different mission and that mission is to protect public health.”
Two items for your consideration:
EC Does It
BioCentury reminds us that the House Energy and Commerce Committee is expected to vote this week on a bill that would allow FDA to collect newly enacted generic drug user fees, a committee spokesperson told BioCentury. The bill does not include a provision that would allow FDA to collect new biosimilar user fees.
Last week, the House of Representatives passed a continuing resolution that would extend funding at current levels for government operations but omitted technical language that would have allowed FDA to benefit from an increase in drug and medical device user fees and to spend the newly enacted user fees for biosimilars and generics.
FDA had planned to use $299 million from new generic drug user fees in FY13 to reduce huge application backlogs, increase postmarket safety oversight, and ramp up inspections of generic drug manufacturers outside the U.S.
Occupy Pharmalot
I was pleased to offer a guest op-ed on Ed Silverman’s Pharmalot blog. Here’s a link. Of particular interest is the comments section. Have a look and see how the other 47% lives.
The Patient Centered Outcomes Research Institute began accepting proposals for up to $96 million in grants for research projects addressing four of its five priorities.
The fifth element, the one it’s ignoring, however, is the most important.
The four priorities are: comparing alternative prevention, diagnosis and treatment options; improving healthcare systems; comparing communication approaches to providing comparative effectiveness research information; and addressing potential differences in prevention, diagnosis or treatment effectiveness, or preferred clinical outcomes across patient populations.
(Earlier this month, on BioCentury This Week, PCORI Executive Director Joe Selby told that low back pain, uterine fibroids and depression could be early targets for comparative effectiveness research.)
What’s not being addressed, is PCORI’s fifth priority, improving the nation's capacity to conduct patient-centered outcomes research by building data infrastructure, improving analytic methods and training researchers, patients and other stakeholders to participate in the research.
Hello! That’s the most urgent need but, alas the least agenda-driven for those whose ultimate goal is a US NICE. After all, why fund programs to advance a science-based understanding of patient outcomes data when you can fund “research” programs to find the best way to “communicate” about comparative effectiveness.
Say it ain’t so Joe.
Since the end of 2011 the FDA has sent 11 warning letters to companies in seven different countries that were exporting drugs to the U.S. after having let their required registration and listing expire.
The warning letter recipients also failed to respond to letters FDA sent them last year notifying them that they were not registered or listed for imports into the U.S., according to nearly identical language in the warning letters.
“FDA has established an ongoing program to identify drug manufacturing firms that have not complied with registration and listing requirements and to notify such firms of their ostensible noncompliance,” the agency said. “FDA has issued warning letters to some of the firms that have not responded to this notification and are out of compliance with registration and listing requirements. These warning letters have targeted firms whose lack of compliance has the greatest potential impact on FDA's regulatory mission.”
FDA’s focus on compliance at foreign drug manufacturing facilities has been sharper since the tainted heparin scandal in 2008, and new provisions in the recently passed user fee legislation is designed to reduce the number of unregistered facilities -- particularly for generic drugs.
But that was before sequestration.
We’ll see.
“The convergence of two powerful forces is driving today’s medical innovation to the top of the national agenda: The urgent need for medical breakthroughs and the unprecedented opportunities created by recent advances in science.”
So said El Lilly & Company’s Grand Poobah John Lechleiter at yesterday’s “Advancing Medical Innovation” summit in Washington, DC. (The event was co-sponsored by Lilly and the Washington Post.) I was pleased to attend.
More Lechleiter:
“Our only hope of breaking our of the crisis is through innovation that changes the terms of the trade-offs we must make and expands the scope of what’s possible.”
The Hoosier Honcho then offered a very potent example of what he meant:
“In the early 1950s, the cost of polio care in the US was predicted to be $100 billion by the year 2000 but, thanks to the advent in 1954 of the polio vaccine, the cost of treating polio in the US in the year 2000 was $100 million.”
In other words – the prediction was off by 99.9% because of game changing innovation. Can we do that again? We’d better try – and try hard.
But Lechleiter offered a crucial caveat, “Realizing the benefits of medical innovation requires an ecosystem where innovation can thrive.”
Are we there yet?
President Obama is wooing seniors with promises to protect Medicare as they've known it. On the defensive because of the $716 billion his health care law takes from Medicare, Obama assures seniors he's cutting payments to hospitals and other providers, not their benefits.
Don't be bamboozled. It's illogical to think that reducing what a hospital is paid to treat seniors won't harm their care. A mountain of scientific evidence proves the cuts will worsen the chance that an elderly patient survives a hospital stay and goes home. It’s reasonable to conclude that tens of thousands of seniors will die needlessly each year.
Under ObamaaCare, hospitals, hospice care, dialysis centers, and nursing homes will be paid less to care for the same number of seniors than if the health law had not been enacted. Payments to doctors will also be cut.
Read more here.
Politico on the Hatch Act violation by HHS Secretary Sebelius:
INDEPENDENT COUNSEL: SEBELIUS CROSSED THE LINE - Limits on political maneuvering by public officials working on the taxpayers' dime are nebulous, byzantine and often blurred. But the Office of Special Counsel - an independent prosecuting authority - has concluded that HHS Secretary Kathleen Sebelius broke the law when she exhorted a North Carolina crowd last February to reelect her boss, President Barack Obama, during what was supposed to be an official visit. The determination - which OSC said was an isolated incident - creates an immediate headache for the Obama administration on a day that Census data showed a dip in uninsured Americans, partly because of the Affordable Care Act.
--From the OSC report: "[Sebelius] noted that North Carolina is critical in the next election and emphasized that it is 'hugely important to make sure we reelect the president.' These statements were made in Secretary Sebelius's official capacity and therefore violated the Hatch Act's prohibition against using official authority or influence to affect the results of an election."
--Sebelius admitted she shouldn't have injected politics into an official event but pointed to her office's immediate decision to reclassify the event as a campaign stop and to reimburse the U.S. Treasury for her travel. More telling, though, was her explanation for the lapse: "As I have also explained, keeping the roles straight can be a difficult task, particularly on mixed trips that involve both campaign and official stops on the same day."
Read more here.
Much important discussion of late about possible new categories for Rx-to-OTC switching – namely erectile dysfunction medicines and statins. But how does this impact consumer information? Consider the impact of the FDA-to-FTC switch.
The FDA requires prescription drug advertising to provide consumers with a "fair balance" of risks and benefits. The FTC, on the other hand, holds drug advertisements to the same standards as other consumer products, requiring a "reasonable" standard of truthfulness.
What’s the impact on how these products are presented to consumers?
According to a new study, when prescription drugs become available over-the-counter, advertisements for the medications are less likely to tell consumers about the potential harms and side effects. This according to Dr. Jeremy Greene, an associate professor in the history of medicine department and the department of medicine at Johns Hopkins University (study published in the September 12th issue of the Journal of the American Medical Association).
Greene and his colleagues analyzed print and broadcast advertisements for four commonly used drugs that were heavily marketed to consumers as prescription drugs and then approved for sale over-the-counter.
The drugs included loratadine (brand name: Claritin, sold over-the-counter since 2002), omeprazole (brand name: Prilosec, went over-the-counter in 2004), orlistat (brand name: Alli, Xenical, sold over-the-counter since 2007), and cetirizine (brand name: Zyrtec, sold over-the-counter since 2008).
When the drugs were available only by prescription, 70 percent of the ads mentioned potential harms. After the drugs were available over-the-counter, only 11 percent did, the investigators found.
After drugs became available over-the-counter, only about half of print and broadcast advertisements mentioned a drug's generic name, compared to 94 percent of ads when drugs were prescription-only. Knowing a drug's generic name can help consumers make sure they're not taking more than one medication that has it as a component, risking overdose, Greene explained.
Greene believes that the FDA should be given authority to regulate marketing of over-the-counter drugs, or perhaps the FTC should adopt guidelines similar to what the FDA requires.
Rather than asking either underfunded agency to take on more work (for which they are neither staffed nor suited), perhaps OTC advertisers should consider what they could do to better educate consumers. After all, a key FDA consideration in approving an Rx-to-OTC switch is whether consumers understand key communication objectives of the label, relating to directions for use, contraindications, in-use warnings and precautions.
Knowledge is power.
A very interesting post from pointoflaw.com:
FDA's "graphic" cigarette warnings struck down
The FDA has suffered another setback in its relentless campaign to turn every cigarette pack into a "mini-billboard" for its anti-smoking agenda. The US Court of Appeals for the DC Circuit has upheld a lower court decision striking down the agency's rules that would require cigarette makers to include certain government-approved "graphic warnings" against smoking. Nothing too extreme, mind you, just a man blowing smoke out of a tracheotomy hole and similar pictures.
As reported last November, U.S. District Judge Richard Leon initially granted a preliminary injunction against the FDA rules. In February of this year, he issued a final ruling striking down the graphic warning requirement as unconstitutional "compelled speech." The DC Circuit affirmed on August 24.
The Supreme Court has long recognized that the First Amendment right to say what you want would be meaningless if the government could force you to say things you don't want. In Wooley v. Maynard, for example, the Court affirmed that Jehovah's Witnesses in New Hampshire could not be forced to use license plates with the State's motto: Live Free or Die.
Although commercial speech often merits less protection under existing precedents, there is clearly a liberty problem with forcing manufacturers to do everything possible to dissuade potential customers from buying their product. As the DC Circuit points out, manufacturers have been compelled to include certain information on labeling or other advertising if the information is (1) strictly factual, and (2) without the information, the company's advertising would be misleading. In this case, however, the FDA doesn't argue that current cigarette labels are misleading -- they include all the textual warnings. The FDA just thinks that the packages aren't scary enough; thus, they would require that 50 percent of the front and back panels of every cigarette pack contain pictures, e.g., of women crying, small children, and the guy with the tracheotomy. As the DC Circuit concluded, the images do not convey factual information, but are "unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat customers into quitting.
And yet, the government would have the courts review its rules under the weakest form of scrutiny available. By the FDA's logic, the government could dictate that every stick of butter be wrapped in images of open-heart surgery, that every candy bar be emblazoned with pictures of rotting teeth, and every sugary drink carry images of obese children -- and these rules would be virtually unreviewable.
The FDA could not even produce evidence that the graphic images would be effective -- the agency estimated a mere 0.088 decrease in smoking rates as a result of the shock-and-awe campaign. Ultimately, the agency seems to want the graphic warnings because "everybody else is doing it." The FDA cited a "strong worldwide consensus" based on the actions of various countries, including Mongolia, Venezuela, Singapore, and Iran. " It is worth noting," the Court said, "that the constitutions of these countries do not necessarily protect individual liberties as stringently as does the United States Constitution." You can say that again.
The case is R.J. Reynolds Tobacco Co. v. FDA, No. 11-5332, slip op. (DC Cir. Aug. 24, 2012).
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.
