Latest Drugwonks' Blog
I don’t watch MTV’s “Jersey Shore.”
Maybe it’s because I’m from Long Island (better beaches, fewer tattoos). Maybe it’s because I’m over 50 (just). But my kids (ages 19 and 23) are fans – and so are all of their friends. So, to paraphrase, “it’s the demographic, stupid.”
A recent CMPI survey was of “Millennial” voters (18-28 years old) revealed some very strong – and often contradictory – opinions a -- particularly when it comes to issue of “universal care.”
The national public opinion poll of young voters (the result of 1001completed interviews with adults 18-28 years of age who are registered to vote) shows limited acceptance for the potential consequences of greater government control over health care.
While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.
Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.
Some germane findings:
* A majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden;
* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,
* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.
And now we can add Snooki.
Here’s an editorial that ran in the August 7th edition of the Wall Street Journal:
Democrats Against ObamaCare
The 1099 repeal fiasco, and the Snooki tax.
This wasn't a good week for ObamaCare, with Missouri voting to repeal the law and a Virginia judge refusing to dismiss a serious Constitutional legal challenge. Unlikely as it sounds, however, the repeal movement even came to include House Democrats.
To wit, the House voted last week to repeal one ObamaCare mandate. It might have been the first part of the bill to go over the side, except Democrats rigged the vote so that it failed, even though it got a majority.
The target was an ObamaCare footnote that could wreak havoc with more than 30 million small businesses. In the name of smoking out the illusory "tax gap" of unreported business income, Democrats snuck in a requirement that companies track and submit to the IRS all business-to-business transactions exceeding $600 annually. This 1099 reporting detail received no scrutiny until the IRS's National Taxpayer Advocate Nina Olson exposed the paperwork burden, which would produce no improvement in tax compliance.
Just before the House left town for August, Dave Camp, the ranking Republican on the Ways and Means Committee, offered an amendment that would have rescinded these mandates; as a "motion to recommit," it was guaranteed an up-or-down vote.
Speaker Nancy Pelosi and wingman Sander Levin were terrified that rank-and-file Democrats would defect, so they pulled their entire bill and reintroduced it a few hours later, with the basic Camp language included. In other words, not only was the House leadership unwilling to defend the 1099 provision but it took the lead in rolling it back, if only to prevent an embarrassing floor spectacle.
One catch: The bill was put on the House suspension calendar, meaning it needed a two-thirds majority to become law. In the end, the combined bill shook out 241 to 154, with 239 Democrats voting yea. Most Republicans who favor repealing the 1099 mandate voted no because the final product also included multiple new taxes. Thus Democrats can now say they voted to repeal the 1099 burden without in fact having repealed it.
This is the first of many such moments as the public discovers ObamaCare's many buried land mines. Another example got some attention last week thanks to Nicole "Snooki" Polizzi, one of the idiot savants on MTV's "Jersey Shore." The reality star complained on air that "I don't go tanning-tanning [indoor tanning] anymore because Obama put a 10% tax on tanning, and I feel like he did that intentionally for us." If you've lost Snooki, you've lost middle America.
Democrats sprung this $2.7 billion excise tax on indoor tanning sessions in the final frantic weeks before ObamaCare passed. The 19,000 very low-margin "mom and pop" businesses that comprise the tanning industry don't have much pull in D.C.
This Snooki levy was the first direct ObamaCare tax hike to take effect—the IRS started to enforce it July 1—and like the 1099 mandate, the compliance burden is drastic. The IRS estimates that it takes 36 hours to complete Form 720, which must be filed quarterly. Tanning salons are now trying to reincorporate as gyms, health clubs or "phototherapists" that are exempt from the new tax.
Democrats write all this and more off as "unintended consequences," but tell that to the intended victims. The only way to fix ObamaCare is to get rid of it.
Please pass the sunscreen.
DDMAC said the content, in most cases a sentence or two, made claims about Tasigna's efficacy, but did not include any risk information. While the shared content included a link to Tasigna websites, which include risk information, DDMAC said it was not sufficient.
FDA is predicting a sharp drop-off in fee-paying drug and biologic applications in the current fiscal year.
In a Federal Register notice announcing the fiscal 2011 PDUFA fee rates for applications, establishments and products, FDA estimates it will receive 117.5 fee-paying full application equivalents in fiscal 2010. This figure represents a 16.3 percent drop from the 2009 level of 140.3 FAEs.
(The 2010 projection of 117.5 FAEs is based upon receipt of 88.125 fee-paying FAEs through the first nine months of the fiscal year. On average, 25 percent of the applications submitted each year come in the final three months, the agency says, citing data from the last 10 fiscal years.)
That means 2010 would mark the lowest number of applications submitted since 1995, when 112.5 FAEs were received by the agency. The 1995 figure, however, did not include pediatric supplements, which were exempt from application fees until 2002. When pediatric supplements are factored in, 1994 was the next lowest year, with 115.6.
Why? It’s largely due to a 25 percent decline in applications requiring clinical data. FDA had received 59 such applications through June 30, of which 17 were either exempt or fees were waived, bringing the total number of fee-paying applications to 42. In contrast, during the first nine months of fiscal 2009 the agency received 88.75 applications requiring clinical data, 32.75 of which were fee-exempt or waived, for a total of 56 fee-paying applications.
The total number of fee-paying applications not requiring clinical data declined 23 percent through the first nine months, from 11 last year to 8.5, while the number of fee-paying supplements requiring clinical data fell 5 percent, from 39 last year to 37. The number of fee-paying applications withdrawn or refused to file held steady at .625.
PDUFA implications? Sure. But the pure decline speaks to a much more troubling issue: a parse pipeline. Now more than ever we need a well-funded Reagan/Udall Center assist us all down the Critical Path.
(Hat tip to Sweet Sue Sutter @ the Pink Sheet.)
Medical journals are full of potboilers writen by hack writers who today throw together reports designed to fit the media's appetite for stories fitting the anti-Big Pharma narrative...
Case in point:
Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov
- Florence T. Bourgeois, MD, MPH;
- Srinivas Murthy, MD; and
- Kenneth D. Mandl, MD, MPH
Can you guess what the conclusion of the study was from the following headline?
Review Suggests Bias in Drug Study Reporting
Industry-funded trials more likely to have positive findings than other studies, analysis shows
www.businessweek.com/lifestyle/content/healthday/641567.htmlYou can spend your own $15 to get this potboiler on line or you can read the juicy parts of the hatchet job here.. You just have to suffer through my commentary.
"Results were considered favorable if they were statistically significant (based on P values or CIs) and supported the efficacy or safety of the test drug or not favorable if they were not statistically significant for the efficacy or safety of the test drug (25). For noninferiority trials, if the test drug was equal to the comparison drug, the results were also classified as favorable."
An industry sponsored study showing any benefit even if barely statistically signiifcant is considered positive. An industry sponsored study showing no difference in outcome in treatment compared to another drug or a placebo... that's also called a positive study.
There is also these important findings:
"Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; P < 0.001 across groups), to use an active comparator in controlled trials (36.8%; P = 0.010 across groups), to be multicenter (89.0%; P < 0.001 across groups), and to enroll more participants (median sample size, 306 participants; P < 0.001 across groups). Government-funded trials were most likely to be placebo-controlled (56.2%), whereas trials funded by nonprofit or nonfederal sources were least likely to be multicenter (24.6%) and tended to have the smallest sample size (median, 50 participants). Industry-funded trials were also most successful at enrolling the anticipated number of participants, with 84.9% of trials enrolling at least 75% of the planned number of participants (P < 0.001 across groups)"
In otherwords, drug companies did more post market studies (increasingly required) and confirmatory trials (always required) that were more diverse and larger. That explains in part the higher percentage of trials showing statistically significant efficacy. Smaller studies that are underfunded and underpowered -- and less likely to enroll the number of patients regarded to achieve a level of confidence that results are reliable: More likely early phase studies looking at other endpoints. No wonder industry sponsored trials are more likely to be "positive." And just to be sure, the researchers toss treatment toss-ups into the positive category. Nothing like creating your own standards. I wonder how many product managers would regard a no-difference result to be "positive."
So the authors twist the obvious into a conspiracy about how industry funding deliberately puts a happy face on otherwise lousy results... But in the world of medical publishing, skewing data to stick to pharma is, dare I say, a positive.
So do the headlines about the study, which I bet few reporters even read.
The Food and Drug Administration proposed shoring up medical-device approval rules that have been criticized as lax and inconsistent by consumer advocates and the agency itself.
The FDA aims to better define what devices can use an approval pathway known as 510(k), under which companies can get an accelerated decision on whether they can market a new product if they can show it is similar to an already approved device. The proposals, which will be open for public comment, will be closely watched by the device industry because more-stringent rules would raise development costs.
The FDA's top device regulator, Jeffrey Shuren, rejected suggestions that the changes would result in fewer devices being eligible for 510(k) approval or raise the need in general for extra medical studies. He said clarity was the main point of the effort.
The FDA began reviewing its medical-device regulations in September after issuing a self-critical report that said top regulators bowed to outside political pressure when approving a ReGen Biologics Inc. knee device in 2008. Articles in The Wall Street Journal had pointed to the political pressure and other irregularities in the ReGen case. ReGen said its device was safe and effective and defended its activities before the FDA.
"There is widespread recognition that there's significant room for improvement in the way we operate," said Dr. Shuren, who directs the FDA Center for Devices and Radiological Health.
The FDA said it wants to develop guidance clarifying when older devices shouldn't be used as a benchmark, or "predicate," for comparison to a new product. The agency is still working on the guidelines, but said there appears to be confusion about the rules.
The agency also proposed creating a subset of Class II devices for which clinical or manufacturing data would be needed to bolster the case that they are substantially equivalent to an already approved product. Class II devices are generally considered to carry moderate risk to patients. Dr. Shuren said drug-infusion pumps, ubiquitous hospital products which the FDA is seeking to improve amid a history of problems, fall into this new "Class IIb" category.
Pump maker Baxter International Inc. is in the process of pulling 200,000 pumps off the U.S. market after the FDA decided it was moving too slowly to fix the devices, whose flaws have included failure to deliver the right amount of medicine.
The device industry's trade group said the proposals included a number of steps that would increase the consistency and predictability of the approval process, but as a whole threatened "significant disruption." Among the industry's complaints are an agency plan to include detailed information about new products, such as design schematics, in a public database. That would give foreign competitors access to proprietary information, potentially hurting U.S. manufacturers, said Stephen J. Ubl, president and chief executive of the Advanced Medical Technology Association.
According to a poll of 802 registered voters by the Pew Charitable Trust's Prescription Project, more than three out of four are confident that prescription drugs made in the USA are free from contamination. However, fewer than one in 10 feel confident about medications made in India or China.
But what “made” represents can be misleading. On the one hand it means “manufactured.” On the other it means “with ingredients from.” And the two aren’t the same thing.
This is an important distinction for a number of reasons – especially when you’re asking the question to a general audience. When you ask someone about their feelings about where a drug is “made,” they are going to assume that “made” means “manufactured.” And while that’s important – it’s only part of the story.
An estimated 80% of the substances used to make or package drugs sold in the United States are made in other countries – and increasingly those “other countries” are India and China. Globally, in 2007, 68% of ingredients of drugs sold worldwide came from India or China, vs. 49% in 2004.
As far as products that are manufactured abroad, it’s important for the American public to understand that the exact same GMP’s are required as a plant in the Lower 48. The Pew poll didn’t share that information. It’s a game changer.
More important is the issue of ingredients sourced from foreign nations. Heparin comes to mind. (In 2007 and 2008, more than 100 patients in the USA died after taking heparin made with a contaminated active ingredient from China.) Attention must be paid and enhanced oversight is essential.
From the legislative standpoint is the Drug Safety and Accountability Act of 2010, to be introduced today by Senator Michael Bennet (D, CO). The bill would empower the FDA to order recalls of unsafe batches of drugs. This recognizes the reality that the concept of “total recall” of a drug is a very 20th century concept.
The "study" is really a restatement of who will get covered when under Obamacare. It duly notes that certain preventive services will not require a copay or deductible and that all health plans will be required to cover pregnancy and maternal care.
The Commonwealth Fund report fails to consider the added cost of buying coverage for such services and ignores the fact that there out of pocket costs associated with maternal care under every health plan. It also fails to note that obtaining ob-gyn coverage under Medicaid is increasingly difficult. In fact, ob-gyn services are hard to find under any circumstances. Just wait till twice as many patients whose care will be reimbursed as one third private insurance rates flood the system.
The report conveys the impression that all these services will be free and widely available. And it does not account for any increase in insurance premiums or efforts to limits coverage of new services to control costs.
tinyurl.com/26wo4br
An FDA advisory committee’s 12-1 vote to remove Avastin’s breast cancer indication is unloved - -and misunderstood – by Senator David Vitter (R, LA) who called the decision “essentially government rationing.”
“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.
Not so.
New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival.
Whether or not you agree with the panel’s viewpoint on the clinical efficacy – they can’t be dinged by making a decision based on cost. That’s just unfair.
While the fear of cost-based care trumping patient-centric medicine is real – the Avastin issue is one of data.
Senator Vitter’s clarion call is accurate – we need to be vigilant to call “comparative effectiveness” what it is – rationing. But this is not the right instance to do so.
A women's health advocacy group that hopes to meet with FDA within the next year to explore potentially switching oral contraceptives to OTC may be hard-pressed to find a pharmaceutical company interested in sponsoring such a venture.
The Oral Contraceptives Over-the-Counter Working Group, coordinated by Ibis Reproductive Health, is "interested in moving oral contraceptives over the counter as a way to increase access to" the drugs, "especially for women who now face barriers to access," such as needing a prescription, said Daniel Grossman, leader of the working group and senior associate at Ibis.
"We are currently in the process of talking with a number of potential partners about what would be needed for a switch, and are hoping to meet with FDA in the next few months to discuss the regulatory pathway," said Grossman, an obstetrician-gynecologist.
One aspect the group needs to explore is finding a drug firm as a partner to sponsor a potential switch application.
Grossman said the working group is not interested in sponsoring a switch application or filing a citizen petition to switch the category.
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.
