Latest Drugwonks' Blog
Per the FDA’s approval of the 5-day emergency contraceptive ella, some perspective. When the FDA reviewed (and reviewed and reviewed) moving the Plan B “morning after” pill OTC in 2003 it was reported as “political interference.” Well it wasn’t true then and it isn’t true now with the approval of a new improved (safe and effective) Rx alternative. The FDA reviews the science and makes it’s decision. The agency is often imperfect and sometimes contentious. But it never lacks for passion or intellectual honesty.
Read more here.
Why, you ask, is it important to pursue the advance of 21st century regulatory science?
Rare Sharing of Data Leads to Progress on Alzheimer’s Disease
By
GINA KOLATA
In 2003, a group of scientists and executives from the
National Institutes of Health, the Food and Drug Administration, the drug and medical-imaging industries, universities and nonprofit groups joined in a project that experts say had no precedent: a collaborative effort to find the biological markers that show the progression of Alzheimer’s disease in the human brain.
The complete New York Times story can be found
Fund Reagan/Udall now!
"While physicians and the life science industry have done little to advance the use of testing for drug-gene interactions, now the pharmacy benefit managers (PBMs) Medco and CVS/Caremark, which collectively administer the employer prescription plans for nearly 100 million Americans, are stepping up. They are introducing wide-scale genotyping for certain drugs, like Plavix or Tamoxifen, and many anti-cancer medications.
- Scripps Health
Why are the PBMs leading the charge? On one hand, the hope is for more efficient use of prescription drugs to get the right drug, right dose and right individual in alignment. But also, since PBMs compete, they want to have an edge beyond simply mailing prescriptions to the large population of constituents they serve. It has caught the medical community by surprise, but may be just the thing that is needed to bring the marked progress in genomics forward for patients."
Understatement of the year.
In his Science article Topol describes as clinical inertia and academic squabbling over methodology continues, PBMs are setting up the infrastructure for the routine use of genetic testing:
There is a simple way to confirm and quantify the extent of platelet response to clopidogrel, using a variety of point-of-care platelet function tests, each of which has been clinically validated to predict long-term prognosis. Furthermore, the information is highly practical, because patients who do not respond to the antiplatelet drug can have their platelet suppression achieved by using higher doses of clopidogrel or prasugrel (Effient) or by using alternative antiplatelet agents that are expected to be approved in the months ahead. Still, the medical community takes no initiative in routinely genotyping patients who are taking clopidogrel. In March 2010, the U.S. Food and Drug Administration (FDA) put a “black box” warning on clopidogrel that addresses the issue of risk in “poor metabolizers,” as defined by genotyping (8). However, months after this action was taken, it remains exceptionally rare for a patient receiving clopidogrel to undergo genotyping. The lesson here is clear: The medical community is unwilling to change clinical practice and wants more evidence, even in the wake of a significant regulatory body warning.
This reluctance on the part of clinicians has left the door wide open for PBMs. These companies can pitch to their clients—large employers—that they are benefiting their employees by avoiding the use of a drug that won’t work or isn’t being administered at an effective dose. For the exceptionally common clopidogrel medication, which costs $4 to $5 per day, the rationale for more precise use and the avoidance of major adverse outcomes seems attractive. In the next year or two, this medication will become generic, so that routine determination of genotype and, if necessary, platelet responsiveness could provide marked cost savings by avoiding the use of a proprietary drug when unnecessary.As Eric notes, commercialization carries pluses and minuses, the balance of which could have been enhanced in favor of patients if doctors and researchers had not been engaged in nit-picking and grant seeking.
"Promoting the right drug, the right dose, and the right cost for patients may well improve the competitiveness of PBMs.
But the potential benefits for PBMs go far beyond this pitch. Under the pretext of personalized medicine, these companies potentially may charge patients or insurance companies for genotyping services—for which the market has doubled over the past 5 years —while at the same time also profiting from the drugs prescribed and sold. This may represent a conflict of interest or at least the potential perception of double- or triple-dipping. It will be important for PBMs that pursue such initiatives to be transparent about their genotyping strategies and drug recommendations."
Still, as Topol notes, it is the PBMs and large health plans -- and the DTC firms in their own haphazard way -- making personalized medicine mainstream. And the long term benefit or externality may be what Ralph Snyderman has envisioned: the regular use of pharmacogenomic data from the sequencing of our own genome to promote prospective and personalized medicine for specific illnesses. Unfortunately it seems that clinicians, regulators (now most particularly the comparative effectiveness crowd) and academia (that see their grant receiving status threatened in some strange way by clinical adoption of gene testing) are way behind the curve and out of sync with patients, payors and entrepreneurs. As Topol notes:
"The lack of alignment will probably be further exacerbated in the next phase of genomic medicine, in which whole-genome sequencing becomes commonplace. The first clinically annotated sequence, albeit requiring a team of 30 investigators and 600 person-hours, demonstrated 63 pharmacogenomic variants of clinical relevance . As more information becomes available from genome-wide association studies that provide actionable data, such as recently reported regarding interferon therapy for hepatitis C , the era for routine pharmacogenomics may finally shift into high gear. In the end, we may ultimately view the surprise movement by PBMs and drugstores as having helped catapult genomic medicine forward. "
Read the full article here.
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.
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.
