Latest Drugwonks' Blog
Not only is so-called “medical tourism” dangerous to the patient –it’s now dangerous to us all.
According to a new report, patients who travel to India and Pakistan for cheaper health care may be at risk from a new type of drug-resistant bacteria.
Researchers have found a gene that enables the bacteria to resist treatment with a class of antibiotics called
carbapenems in 1.9 percent of samples from patients in the Indian states of Tamil Nadu and Haryana, according to the study in the journal Lancet. Reports from 37 patients in the U.K. who had the resistant strains were also analyzed, and the researchers found that most had received treatment at hospitals in India and Pakistan.
In the last three to four years, this kind of resistance has, according to the study, “increased dramatically in India and continues to increase … The possibility of this becoming a global problem very quickly is immense.”
Hospitals in the U.K. began reporting cases of patients with this type of resistance in mid-2008, said David Livermore, director of the antibiotic resistance monitoring unit at the U.K.’s Health Protection Agency
In addition, medical tourists would be well advised to take their own medications with them.
In many places like Turkey, for instance, which is increasingly popular with medical tourists, it takes 2-4 years to register medicines available in Europe or North America. The result is a strong possibility that in medical tourism “destination locations” the latest and most promising full range of medicines may not be available. This could have consequences prior to, during or post procedure for patients, who may have to rely on older, or less effective medicines than would be offered in North America or Europe.
Health Ministries and the medical tourism industry are happy to boast their countries as hot new destinations for procedures, but the ugly under-belly missed by most medical tourists (and not publicly discussed by either governments or “tourism operators”) is the all too often yawning "innovative medicines gap" between home and abroad.
According to a new study in the Archives of Internal Medicine (Winterstein AG, et al "Evaluation of consumer medical information dispensed in retail pharmacies" Arch Intern Med 2010; 170(15): 1317-13240), The content, formatting, and word count of leaflets pharmacies hand out with medicines leave much to be desired and should be subject to FDA guidance.
The FDA regulates label information and guides that accompany drugs with safety concerns but not the content and format of consumer medication information (CMI) documents. The agency does, however, have a set of eight standards for CMI leaflets:
- State drug name and indication
- List contraindications
- Include directions about use
- Note precautions and potential harms
- List symptoms of possible adverse reactions
- Include general information and encourage patients to ask questions
- Be scientifically accurate
- Be comprehensible and legible
To assess the consistency of these documents, "professional shoppers" filled prescriptions in a national sample of 365 independent and chain pharmacies.
Leaflets for the same product ranged from 33 to 2,482 words, with more than 1,000-word differences among those meeting the highest quality of content. This suggests "large variations in conciseness," the researchers wrote. Less than a third of leaflets used font size of 10 points or larger. Only 10% of leaflets were written at or below an eighth-grade reading level. About 6% of pharmacies didn't provide any written leaflets.
The researchers also noted that chain pharmacies had better adherence to content criteria than did independent stores.
The researchers concluded that the "usefulness of CMI ultimately depends on meeting the needs of patients for information that facilitates the understanding and management of their therapies."
Knowledge is Power.
And here is the supposed knockout blow:
Except, Dr. Green and Melissa, if we assume that both of you are human beings too isn't it also the case that the studies attacking the biological evidence showing a casual relationship between inflammation and heart attacks as well as the LA Times story are also shaped by ' self-interest incentives'.
The difference is 'the studies' - which Melissa apparently never read -- are simply data dredging exercises spurred by those who resent commercial development of science and who also profit from their attacks, whereas the Jupiter study had to be approved by the FDA, is based on prior biologically based experiments.
But neither Dr. Green or Melissa regard those self interest incentives as important.
Apparently people like Dr. Green and Melissa believe they know best.
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.
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.
