Reasonably sophisticated patients don't order drugs from unknown vendors on the internet. Cautionary tales of counterfeit or adulterated drugs abound, and if one has a serious medical condition, that cheap internet drug may cause trouble, perhaps even death.
But what about the drugs you get from your local or mail order pharmacy? Aren't those drugs certain to be the genuine branded product or a generic bioequivalent?
If you attended law school, the police academy, are a regular viewer of one of the CSI series programs, or if you work for the United States Postal Service handling "Registered Mail" you have probably heard about the "chain of evidence" or "chain of custody." You know that for the chain to be valid, there must be specific contemporaneous written documentation of custody and transfer of custody at each and every step during which it is handled. You might make the assumption that there is a similar chain of evidence for the drugs delivered to you by your pharmacy (local or mail order) in accordance with your doctors' prescriptions. Sorry, this isn't CSI, law school, the Post Office, or a courtroom. If you want to see a puzzled, annoyed, look on your pharmacist's face, ask if he or she knows (and how he or she knows) where and by whom the drug sold to you was produced, whether there is documentation of each step and party in the distribution process, that the drugs you received were actually delivered and received by intermediate parties in the very same sealed containers as they were delivered in, and whether the pharmacist can guarantee that the drug that the pharmacy delivers to you is the genuine branded product or a bioequivalent generic. Unfortunately, our prescription drugs have been commoditized, and the handlers anonymized, so that our faith in the products we receive may be unfounded.
If enough people asked the questions I described, perhaps the distribution process would become transparent instead of opaque. Perhaps instances of expensive counterfeit drugs would be less common. Perhaps some of the drugs we take would help us, rather than hurt us. If you can't a responsible and responsive answer to the questions, contact your Congressperson.
My personal experience was that the FDA was totally unresponsive, even when there was a serious basis to believe that I had been provided with an inactive counterfeit drug. And by the way, the local branch of the chain pharmacy hadn't a clue to what was going on and had no interest in helping me find out when I returned the suspect drug to them.
Saturday, May 17, 2008
Thursday, May 15, 2008
Who Sets The Standard of Medical Practice?
Commercial support of continuing medical education ("CME") is a widespread practice. Sometimes the sponsor links its name to the program or presenter. Sometimes, a calculated distance is maintained between the sponsor and the program by use of intermediaries or donation to a program "fund." In each case, the unspoken part is the commercial sponsor’s message, “we define the standard of care,” delivered by paid advocates through continuing medical education (CME).
"Sponsored education" is not restricted to physicians and other health care providers. The United States is unusual in that it permits direct advertising of pharmaceuticals (technically known as "dangerous drugs") to consumers. Like CME, consumer advertising implicitly dismisses physicians, who do not prescribe its product, as substandard and suggests that the consumer “find a better doctor.” Some CME speakers talk about the “efficiency” of prescribing the drug they are touting that day, but their real message (often couched as biased interpretations of flawed research) is that failure to prescribe or use the commercial supporter’s branded product means that the physician does not meet generally accepted standards of care and is inferior.
Defensive medicine is not limited to ordering unnecessary X-rays, tests and procedures. The subtle message of commercially sponsored CME, “meet the standard of care by prescribing our products,” keys into physicians’ fears of malpractice lawsuits, adverse peer review, and action by state medical boards. The results are defensive, unnecessary, costly and sometimes dangerous prescriptions and orders. The subtle message adds to our health care deficit.
Patients, the public, and our professions are paying a dear price for that free meal, lecture, slide show and hour of CME credit. Patients are taught to depend on pharmaceutical company advertising and to distrust their physicians and other health care providers. I believe it is time to terminate the destructive franchise we have given to commercial supporters of CME and direct consumer pharmaceutical advertising.
"Sponsored education" is not restricted to physicians and other health care providers. The United States is unusual in that it permits direct advertising of pharmaceuticals (technically known as "dangerous drugs") to consumers. Like CME, consumer advertising implicitly dismisses physicians, who do not prescribe its product, as substandard and suggests that the consumer “find a better doctor.” Some CME speakers talk about the “efficiency” of prescribing the drug they are touting that day, but their real message (often couched as biased interpretations of flawed research) is that failure to prescribe or use the commercial supporter’s branded product means that the physician does not meet generally accepted standards of care and is inferior.
Defensive medicine is not limited to ordering unnecessary X-rays, tests and procedures. The subtle message of commercially sponsored CME, “meet the standard of care by prescribing our products,” keys into physicians’ fears of malpractice lawsuits, adverse peer review, and action by state medical boards. The results are defensive, unnecessary, costly and sometimes dangerous prescriptions and orders. The subtle message adds to our health care deficit.
Patients, the public, and our professions are paying a dear price for that free meal, lecture, slide show and hour of CME credit. Patients are taught to depend on pharmaceutical company advertising and to distrust their physicians and other health care providers. I believe it is time to terminate the destructive franchise we have given to commercial supporters of CME and direct consumer pharmaceutical advertising.
Wednesday, May 14, 2008
FDA Seeks Funding for Inspecting Foreign Products
The New York Times caption at page A13, May 14, 2008, provocatively reads "F.D.A. Chief Writes Congress for Money." The F.D.A. request may provide insight into Congress' willingness to solve serious American health system problems.
Contaminated human food, drugs (most recently heparin), and other related health products (including pet food) from foreign sources have become a major threat to Americans' health. The article notes that the request for $275 million went to Senator Arlen Spector, who had previously written to FDA Commissioner von Eschenbach asking how much money the F.D.A required to protect the public health, and outlined a spending plan which included opening new foreign offices, increasing inspections and constructing new databases to follow drug hazards.
Perhaps Congress will obtain a verifying Congressional Budget Office estimate of the actual amount the F.D.A. needs to do its job (meeting the agenda which Congress has set for it) since, even with von Eschenbach's apparent assertion of independence from Administration budget priorities, it is not clear how much of an infusion is necessary on an ongoing basis. Perhaps, too, Congress will appropriately fund the F.D.A. on a regular basis rather than provide it with legislative mandates which cannot be carried out because of inadequate and politically cynical Congressional funding.
The resolution of this issue will affect the health safety of Americans. Once the spotlight of the 2008 national election has been turned-off, we should keep on eye on our Representatives' and Senators' votes and monitor the new Administration spendable funding for the F.D.A.. In an environment of financial crisis, Congress and political leadership, like old dogs, may prefer their old tricks.
Contaminated human food, drugs (most recently heparin), and other related health products (including pet food) from foreign sources have become a major threat to Americans' health. The article notes that the request for $275 million went to Senator Arlen Spector, who had previously written to FDA Commissioner von Eschenbach asking how much money the F.D.A required to protect the public health, and outlined a spending plan which included opening new foreign offices, increasing inspections and constructing new databases to follow drug hazards.
Perhaps Congress will obtain a verifying Congressional Budget Office estimate of the actual amount the F.D.A. needs to do its job (meeting the agenda which Congress has set for it) since, even with von Eschenbach's apparent assertion of independence from Administration budget priorities, it is not clear how much of an infusion is necessary on an ongoing basis. Perhaps, too, Congress will appropriately fund the F.D.A. on a regular basis rather than provide it with legislative mandates which cannot be carried out because of inadequate and politically cynical Congressional funding.
The resolution of this issue will affect the health safety of Americans. Once the spotlight of the 2008 national election has been turned-off, we should keep on eye on our Representatives' and Senators' votes and monitor the new Administration spendable funding for the F.D.A.. In an environment of financial crisis, Congress and political leadership, like old dogs, may prefer their old tricks.
Sunday, May 11, 2008
Clinical Competence or Electronic Medical Records?
It may seem unfair to ask: "do you favor clinical competence over electronic medical records"? But today, the United States doesn't have enough dollars to pay for health care for its entire population. Use of billions of dollars of scarce resources to pay for electronic medical records systems will divert money from training competent clinicians in evidence-based medicine and may have a detrimental effect on health care.
Pysician, nurse, and nurse practitioner training programs stress the mantra: show us the evidence for the diagnosis you make and the treatment you prescribe. Unfortunately, health systems administrators, insurers, politicians and others who control the flow of health care dollars are not required to show solid evidence supporting their rush to electronic medical records. The information technology industry claims superiority for its products. Politicians, bureaucrats and administrators wax enthusiastic about their chance to spend billions of dollars on technology which does not yet demonstrate patient health outcome superiority as compared to traditional paper records and systems. The issue isn't whether a computer generates a pretty report for a mid-level administrator; it is whether the patient lives or dies or suffers severe medically unnecessary complications or pain.
Citing two studies of handheld electronic medical record systems, a 2006 Canadian abstract did not find conclusive evidence of a net benefit from the use of the handheld medical record system. It did report an increase in the number of wrong or redundant diagnoses (http://www.biomedcentral.com/1472-6947/6/26/abstract downloaded 5/11/2008).
Crosson and others reported the effects of electronic medical records on diabetes care in an NIH funded study (http://www.annfammed.org/cgi/content/full/5/3/209 downloaded 5.11.2008). Statistical analyses demonstrated no evidence of an improvement in ultimate outcome. Surprisingly ". . . . patients with diabetes in practices that did not have an EMR were significantly more likely to have received care that met the guidelines for processes of care, treatment, and intermediate outcomes".
There is literature claiming that electronic medical records systems show a good return on investment (http://www.medicalnewstoday.com/articles/76786.php downloaded 5/11/2008). Where are comparable studies demonstrating that the money spent for such expensive systems show a net benefit to patient outcomes. Where is the answer to the mantra: show us the evidence?
Pysician, nurse, and nurse practitioner training programs stress the mantra: show us the evidence for the diagnosis you make and the treatment you prescribe. Unfortunately, health systems administrators, insurers, politicians and others who control the flow of health care dollars are not required to show solid evidence supporting their rush to electronic medical records. The information technology industry claims superiority for its products. Politicians, bureaucrats and administrators wax enthusiastic about their chance to spend billions of dollars on technology which does not yet demonstrate patient health outcome superiority as compared to traditional paper records and systems. The issue isn't whether a computer generates a pretty report for a mid-level administrator; it is whether the patient lives or dies or suffers severe medically unnecessary complications or pain.
Citing two studies of handheld electronic medical record systems, a 2006 Canadian abstract did not find conclusive evidence of a net benefit from the use of the handheld medical record system. It did report an increase in the number of wrong or redundant diagnoses (http://www.biomedcentral.com/1472-6947/6/26/abstract downloaded 5/11/2008).
Crosson and others reported the effects of electronic medical records on diabetes care in an NIH funded study (http://www.annfammed.org/cgi/content/full/5/3/209 downloaded 5.11.2008). Statistical analyses demonstrated no evidence of an improvement in ultimate outcome. Surprisingly ". . . . patients with diabetes in practices that did not have an EMR were significantly more likely to have received care that met the guidelines for processes of care, treatment, and intermediate outcomes".
There is literature claiming that electronic medical records systems show a good return on investment (http://www.medicalnewstoday.com/articles/76786.php downloaded 5/11/2008). Where are comparable studies demonstrating that the money spent for such expensive systems show a net benefit to patient outcomes. Where is the answer to the mantra: show us the evidence?
Wednesday, May 7, 2008
Res Ipsa Loquitor (for all you tort lawyers)
Institutional conflict of interest among physicians who treat Lyme disease, about Lyme disease and its treatment? After looking at Hilary Waldman's article in the Hartford Courant (5/2/08),“Agreement is reached on Lyme disease, http://.courant.com/news/health/hc-ctlyme0502.artmay02,0,5245299.story, take a look at the agreement between the State of Connecticut and the Infectious Diseases Society of America at
http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf.
It's enough to make you sick!
http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf.
It's enough to make you sick!
Sunday, May 4, 2008
Olympics, China, Hand Foot & Mouth Disease
With the beginning of the Olympic games in China, days away, the outbreak of hand, foot and mouth disease ("HFMD") in that country, with associated childrens' deaths, is a cause for some concern. If visitors from the United States are exposed to the virus and bring it back to the US with them, there is a risk of an epidemic which may further test our already stressed health system.
Hand, foot and mouth disease, a highly infectious and easily spread viral disease, is causing death among Chinese children and is beginning to spread among children in Vietnam and Singapore, as well http://www.breitbart.com/article.php?id=2008-05-04_D90ETD5G1&show_article=1&cat=breaking. HFMD may be caused by either a coxackie virus A16 or EV71. EV71 may also cause viral meningitis and, rarely, more serious diseases, such as encephalitis, or a poliomyelitis-like paralysis. EV71 encephalitis may be fatal. Cases of fatal encephalitis occurred during outbreaks of HFMD in Malaysia in 1997 and in Taiwan in 1998.EV71 encephalitis may be fatal. http://www.cdc.gov/ncidod/eid/vol9no1/02-0112.htm
According to the CDC, hand, foot, and mouth disease (HFMD) is a common illness of infants and children which is characterized by fever, sores in the mouth, and a rash with blisters. It begins with a mild fever, poor appetite, malaise ("feeling sick"), and frequently a sore throat. Then, one or 2 days after the fever begins, painful sores develop in the mouth which begin as small red spots that blister and then often become ulcers. They are usually located on the tongue, gums, and inside of the cheeks. The skin rash develops over 1 to 2 days with flat or raised red spots, some with blisters. The rash does not itch, and it is usually located on the palms of the hands and soles of the feet. It may also appear on the buttocks. A person with HFMD may have only the rash or the mouth ulcers. http://www.cdc.gov/ncidod/dvrd/revb/enterovirus/hfhf.htm
According to the CDC, HFMD is moderately contagious. Infection is spread from person to person by direct contact with nose and throat discharges, saliva, fluid from blisters, or the stool of infected persons. A person is most contagious during the first week of the illness. HFMD is not transmitted to or from pets or other animals.
No specific treatment is available for this or other enterovirus infections. Symptomatic treatment is given to provide relief from fever, aches, or pain from the mouth ulcers.
Hand, foot and mouth disease, a highly infectious and easily spread viral disease, is causing death among Chinese children and is beginning to spread among children in Vietnam and Singapore, as well http://www.breitbart.com/article.php?id=2008-05-04_D90ETD5G1&show_article=1&cat=breaking. HFMD may be caused by either a coxackie virus A16 or EV71. EV71 may also cause viral meningitis and, rarely, more serious diseases, such as encephalitis, or a poliomyelitis-like paralysis. EV71 encephalitis may be fatal. Cases of fatal encephalitis occurred during outbreaks of HFMD in Malaysia in 1997 and in Taiwan in 1998.EV71 encephalitis may be fatal. http://www.cdc.gov/ncidod/eid/vol9no1/02-0112.htm
According to the CDC, hand, foot, and mouth disease (HFMD) is a common illness of infants and children which is characterized by fever, sores in the mouth, and a rash with blisters. It begins with a mild fever, poor appetite, malaise ("feeling sick"), and frequently a sore throat. Then, one or 2 days after the fever begins, painful sores develop in the mouth which begin as small red spots that blister and then often become ulcers. They are usually located on the tongue, gums, and inside of the cheeks. The skin rash develops over 1 to 2 days with flat or raised red spots, some with blisters. The rash does not itch, and it is usually located on the palms of the hands and soles of the feet. It may also appear on the buttocks. A person with HFMD may have only the rash or the mouth ulcers. http://www.cdc.gov/ncidod/dvrd/revb/enterovirus/hfhf.htm
According to the CDC, HFMD is moderately contagious. Infection is spread from person to person by direct contact with nose and throat discharges, saliva, fluid from blisters, or the stool of infected persons. A person is most contagious during the first week of the illness. HFMD is not transmitted to or from pets or other animals.
No specific treatment is available for this or other enterovirus infections. Symptomatic treatment is given to provide relief from fever, aches, or pain from the mouth ulcers.
Thursday, May 1, 2008
Genetic Information Nondiscrimination Act Passed
This afternoon, May 1, 2008, the House of Representatives approved the Senate-passed version of the Genetic Information Nondiscrimination Act (GINA) (H.R. 493) by a vote of 414 to 1. The President is expected to sign the Act.
The American Society of Hematology, which advocated for the Act, noted in its release May 1, 2008:"GINA will prohibit health insurers from using individuals' genetic information to deny coverage or determine rates or premiums. In addition, the bill would bar employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions."
For coverage of the Senate passed genetic antidiscrimination act, see:
Chicago Tribune April 25, 2008 article by Judith Graham, Tribune Reporter:
http://www.chicagotribune.com/features/lifestyle/health/chi-genetic-discrimination_25apr25,1,4203765.story
Also see Kaiser's: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51751
To read the text (110 pages): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h493eas.txt.pdf
The American Society of Hematology, which advocated for the Act, noted in its release May 1, 2008:"GINA will prohibit health insurers from using individuals' genetic information to deny coverage or determine rates or premiums. In addition, the bill would bar employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions."
For coverage of the Senate passed genetic antidiscrimination act, see:
Chicago Tribune April 25, 2008 article by Judith Graham, Tribune Reporter:
http://www.chicagotribune.com/features/lifestyle/health/chi-genetic-discrimination_25apr25,1,4203765.story
Also see Kaiser's: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51751
To read the text (110 pages): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h493eas.txt.pdf
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