Latest Drugwonks' Blog
The Florida Medical Association decided Sunday after two days of heated debate not to break off relations with the American Medical Association, officials and delegates said at the conclusion of the event.
Instead, FMA will send AMA a letter describing just how unhappy it is with the national group’s actions on health reform.
In a formal written statement, Executive Vice President Timothy J. Stapleton said that the FMA letter will convey a vote of “no confidence.” “The FMA House of Delegates strongly believes that the American Medical Association has failed to represent practicing physicians on the issue of health care reform.”
One of the delegates, Tampa surgeon Michael Wasylik, said, "Doctors are really, really, really upset with the AMA. Doctors are so angey they can't see straight.
And not seeing straight is a bad place for a surgeon to be.
marketplace.publicradio.org/display/web/2010/08/16/am-fda-may-revoke-breast-cancer-drug-q/
German authorities have filed charges against pharmacies in the north of the country that have been suspected of purchasing cheap and illegal active ingredients, which they have used to manufacture in-house cancer treatment preparations and then sold them to the general public.
Frank Keller, chief investigator of the Technician's Health Insurance Fund (TKK), as saying that the fund had been tipped off that a Danish wholesaler had been supplying German pharmacies with an unauthorized active ingredient for the preparation of an infusion used in cancer treatment. Some 100 of the 400 pharmacies authorized to manufacture the preparation in-house are suspected of having purchased the cheap, illegal product from the wholesaler.
Separately, Alexander Retemeyer from the Office of Public Prosecution in Osnabruck, revealed that he had tracked a local wholesaler, which had sourced illegal products from Eastern Europe and then sold them to pharmacies.
In the latest revision to the Pharmaceutical Act, the German government has put in place measures to sanction those who introduce counterfeits into the health system. The European Union is also concerned about the increase of falsified medicines emerging in the Member States. Figures from the Directorate General for Taxation and Customs show that counterfeit medicines accounted for 10 percent of goods seized upon entering the EU. Almost 75 percent of these were shipped from the United Arab Emirates.
In April, the European Parliament's Environment Committee approved the European Commission's proposal for fighting counterfeit medicines. The committee added a stipulation to the draft, which insists that in addition to preventing counterfeits from entering the legal supply chain and introducing mandatory safety features for prescription medicines, the legislation should prohibit internet sales of “detrimental products.” The EU Parliament will vote on the draft proposal in October.
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.
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.
