Urgent: Support the Proposed New
Law in California Requiring Doctors to Provide Patients with Information on Diabetes and
Heart Disease
Patients often receive inadequate and/or
incorrect information from their doctors on diabetes and heart disease. Last month’s
newsletter was on the heart disease side of this bill. Concerning type-2 diabetes, health
professionals and pharmaceutical companies disseminate incorrect and inadequate
information on these four important issues:
1) Patients are told diabetic medications
for type-2 diabetes will prolong life and prevent complications of diabetes, while
extensive scientific research says otherwise for the most commonly prescribed oral
medications.
2) Patients are told that their blood
sugars (and hemoglobin A1c levels) must be lowered as close to normal levels as possible.
However, all six major studies show intensive therapy increases the risk of heart disease,
death, and serious side effects.
3) The public receives almost no education
about the role of the rich Western diet in the cause of type-2 diabetes and about the
right way to eat to prevent this disease.
4) Patients are rarely told that changing
to a healthy, low-fat, plant-food based diet, exercise, and associated weight loss will
improve their health and often cure their type-2 diabetes.
Assembly Bill 1478 has been introduced by
California state assembly member Tom Ammiano, representing the 13th District, to require
that a physician obtain a patient's written acknowledgment confirming the receipt of
information, as specified, regarding treatment through medical nutrition therapy prior to
delivering nonemergency treatment for type-2 diabetes. My supporting letter on this matter
is provided below. Last month’s newsletter (March 2009) has a similar letter from me
about heart disease treatments and a request for your support.
New E-mail and Fax numbers for Assembly Members:
Write to these policymakers about the need
for change for both heart disease and diabetes treatments.
Please send letters to members of the
Business & Professions Committee (who are initially reviewing this bill) asking them
for their support of AB 1478. Send a CC to jimlaw@jps.net for an additional hand delivery
of your letter to committee members. A sample letter is provided at the end of this
article. Here are their e-mail addresses and faxes:
B&P consultants to the Assembly member:
For Mary Hayashi:
Assemblymember.hayashi@assembly.ca.gov
916 319 2118
For Bill Emmerson:
Assemblymember.emmerson@assembly.ca.gov
916 319 2163
For Connie Conway:
Assemblymember.conway@assembly.ca.gov
916 319 2134
For Mike Eng:
dave.martin@asm.ca.gov
916 319 2149
For Ed Hernandez:
Assemblymember.hernandez@assembly.ca.gov
916 319 2157
For Pedro Nava:
Assemblymember.nava@assembly.ca.gov
916 319 2135
For Roger Niello:
Assemblymember.niello@assembly.ca.gov
916 319 2105
For John Perez:
Assemblymember.John.Perez@assembly.ca.gov
916 319 2146
For Curran Price:
Curren.price@asm.ca.gov
916 319 2151
For Ira Ruskin:
Assemblymember.ruskin@assembly.ca.gov
916 319 2121
For Cameron Smyth:
Assemblymember.smyth@assembly.ca.gov
916 319 2138
For Sarah Huchel B&P
Consultant:
sarah.huchel@asm.ca.gov
916 319 3306
Dr. McDougall’s Letter of Support for AB 1498:
Requirement to Inform Patients in Writing
about the Adverse Effects of Pharmaceutical Treatments and the Benefits of Nutritional
Therapies for Type-2 Diabetes.
The Patients’ Right to Informed
Consent
Informed consent is a patient right
guaranteed by the bylaws of most hospitals. California law requires that a patient’s
consent be obtained in writing for several specific procedures and treatments, including:
sterilizations, hysterectomy, breast cancer, prostate cancer,
gynecological cancers, psychosurgery, and electroconvulsive therapy, but not for type-2
diabetes treatments.1 California patients with type-2 diabetes need to be informed in
writing about the lack of benefits and the real harms of current therapies with oral and
injectable medications. They also need to be told that the cause of their diabetes is the
rich Western diet and associated weight gain, and that their condition is reversible with
a change in diet, exercise, and weight loss.
The Diabetes Epidemic
According to the National Institutes of
Health (NIH) in 2007 a total of 23.5 million, or 10.7
percent, of all people aged 20 years or older in the US have diabetes at a cost of $174
billion.1a The vast majority of this diabetes is type-2 diabetes, caused by over-nutrition
from the rich Western diet, and the associated weight gain. Eighty-four percent of
diabetics are on medications (insulin and/or oral).1a Born in the year 2000, a male
child’s lifetime risk of developing type-2 diabetes is nearly 33%, and a
female’s risk will be 39% when following the Western diet.2 The escalating incidence
of type-2 diabetes clearly indicates that current efforts at prevention and treatment are
failing. The reason for this failure is the almost exclusive emphasis on drug therapies,
and the lack of efforts to address the dietary and lifestyle causes and treatments of
type-2 diabetes .
The Failure of Non-emergency Diabetic
Medications
Diabetic medications are approved by the
FDA for market based upon their ability to lower
blood sugar levels, not based on any improvements in the quality or quantity of the
patients’ lives.3 In a major study, a popular diabetic medication, Avandia
(rosiglitazone), given at a dosage of 4 mg twice daily, on average, decreased hemoglobin
A1c levels by 1.5 percentage points, reduced fasting plasma sugar by 76 mg/dL (4.22
mmol/L), and reduced insulin resistance by 25%.4 These improved numbers should have meant
healthier patients, but they didn’t. On May 21, 2007 the New York Times reported,
“…patients taking Avandia had 66 percent more heart attacks, 39 percent more
strokes and 20 percent more deaths from cardiovascular-related problems.”5,6 Since
1972, the Physicians Desk Reference (PDR) descriptions of most diabetic pills have
included two paragrap hs in heavy black print that begin with: “Special Warning on
Increased Risk of Cardiovascular Mortality.” This warning is because a very commonly
prescribed oral medication, called sulfonylurea, increases the risk of cardiovascular
death by 2½ times compared to diet treatment alone.
Mediations (oral and injectable) for type-2
diabetes are prescribed aggressively by physicians with the unfounded belief that better
control of blood sugar will result in better long-term outcomes for the patients. All six
major studies published over the past 13 years have shown otherwise. Three major studies
published between 1996 and 2000 found more weight gain, higher cholesterol, triglycerides,
and blood pressure; and more heart disease, stroke, and/or death with
“aggressive” treatment compared to less treatment.7-9
This past year, 2008, three landmark
studies, ACCORD, ADVANCE, and VADT, were published in the New England Journal of Medicine.
All three showed aggressive treatment does more harm than good.10-12 On February 6, 2008
the National Heart, Lung, and Blood Institute (NHLBI), stopped the ACCORD study (Action to
Control Cardiovascular Risk in Diabetes) when results showed that intensive treatment of
diabetics increases the risk of dying compared to those patients treated less
aggressively.13 Patients in the intensive group were oftentimes taking four shots of
insulin and three pills daily, and checking their blood-sugar levels four times a day.10
The Veterans Affairs Diabetes Trial (VADT)
was based on 1791 military veterans with type-2 diabetes.12 Patients were assigned to
receive either intensive- or standard-glucose control nd studied for 5.6 years. The
intensive-therapy reduced their hemoglobin A1c levels to 6.9%; compared to 8.4% in the
standard-therapy group. A weight gain of 18 pounds occurred with the intensive-treatment,
compared to 9 pounds with standard-therapy. There were 95 deaths from any cause in the
standard-therapy group and 102 in the intensive-therapy group. In the intensive-therapy
group, the number of sudden deaths was nearly three times the number of those in the
standard-therapy group (11 vs. 4). More patients in the intensive-therapy group had at
least one serious adverse event, predominantly hypoglycemia, than in the standard-therapy
group.
The Efficacy of Diet-therapy
Drug therapy has consistently failed
patients with type-2 diabetes, making search for an
alternative treatment imperative. Since the rich Western diet is agreed to be the cause of
this epidemic, should diet not be the first place to look for the prevention and the
cure?14
Studies on the benefits of a low-fat, high-carbohydrate, plant-food-based diet on type-2
diabetes date back to 1930.15 Several published studies demonstrate how type-2 diabetics
can stop insulin and get off oral diabetic medications with a change in diet.16-18 Heart
disease accounts for 70% of the deaths in diabetics. By great fortune, this same low-fat,
low-cholesterol diet (successfully used for diabetes therapy) has been shown to prevent
and treat heart and kidney disease, and prevent many common forms of cancer.
A study recently published in Diabetes Care
found a low-fat, plant-food-based diet improved the health of people with type-2 diabetes
even more than the American Diabetes Association (ADA) Diet did.19 Forty-three percent of
the plant-food group and 26% of the ADA group participants reduced their diabetes
medications. Reductions of hemoglobin A1c, LDL “bad” cholesterol, and urine
protein were greater in the plant-food group, than those on the ADA diet. People following
the plant-based diet could eat unlimited amounts of food, while those on the ADA diet were
required to control their portion sizes—and compliance was better on with the
plant-food-based diet. Exercise did not play a role in this study.20
Low-carbohydrate, high-protein diets have
also been shown to cause people to lose weight and reduce their blood sugar levels.21
However, these kinds of diets are also high in fat, high in cholesterol, and very low in
dietary fiber; therefore, they cannot be recommended. The American Heart Association,
because of their disease-causing effects, has condemned low-carbohydrate diets.22
Cost Savings to the State of California
Over 2 million Californians currently have
diabetes, and the number of Californians with
diabetes is expected to double by 2025.23 In California in 2003, the total direct and
indirect costs of diabetes were estimated to be more than $17.9 billion per year.24
Obesity threatens to surpass tobacco as the leading cause of preventable death among
Californians and obesity costs the state $28.5 billion in health care expenses, lost
productivity, and workers' compensation.23 A cost-benefit analysis published in the
October-December 2006 issue of the University of California’s California Agriculture
journal has determined that every dollar spent on nutrition education in California saves
between $3.67 and $8.34 in future medical costs.25 The current drug therapies for type-2
diabetes promote both obesity and heart disease—widespread utilization of die
t-therapy will reduce the costs and incidence of all three epidemics (diabetes, obesity,
and heart disease), saving California billions of dollars.
Sample Letter to Assembly Member
Dear Assembly Member (their name):
I am writing to ask you to vote for AB
1478. Chronic diseases like heart disease and diabetes are epidemic in America and
California. From my personal experience I know that while drug medication can be of value
in emergency situations, drugs ultimately never cure the disease – they only suppress
the symptoms of the disease. This is an expensive way to treat diseases. Our state cannot
anymore afford the high cost of treating patients with drugs and surgery alone. Diet and
lifestyle changes have been found to be helpful in arresting and even curing heart disease
and diabetes, and are very inexpensive compared to drugs and surgery. I feel doctors
should give their patients the option to be referred out for diet advice and nutrition
therapy for their non-emergency heart disease or diabetic condition. Doctors also must be
required by law to tell the truth about the limitations of current treatments.
Thank you very much for your support for AB
1478.
Sincerely,
Your name, address, and e-mail
References:
1) http://www.calpatientguide.org/ii.html
1a)
http://diabetes.niddk.nih.gov/DM/PUBS/statistics/
2) Narayan KM. Lifetime risk for diabetes
mellitus in the United States. JAMA 2003; 290:
1884-90.)
3)
http://www.medscape.com/viewarticle/585593
4) Lebovitz HE, Dole JF, Patwardhan R,
Rappaport EB, Freed MI; Rosiglitazone Clinical Trials
Study Group. Rosiglitazone monotherapy is effective in patients with type 2 diabetes. J
Clin
Endocrinol Metab. 2001 Jan;86(1):280-8.
5)
http://www.nytimes.com/2007/05/22/business/22drug.html?pagewanted=print
6) Nissen SE, Wolski K. Effect of
rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N
Engl J Med. 2007 Jun 14;356(24):2457-71
7) Purnell JQ. Effect of excessive weight
gain with intensive therapy of type 1 diabetes on
lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications
Trial. JAMA. 1998 Jul 8;280(2):140-6.
8) Colwell JA, Clark CM Jr. Forum Two:
Unanswered research questions about metabolic
control in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996 Jan 1;124(1 Pt
2):178-9.
9) Gustafsson I, Hildebrandt P, Seibaek M,
Melchior T, Torp-Pedersen C, Kober L,
Kaiser-Nielsen P. Long-term prognosis of diabetic patients with myocardial infarction:
relation to antidiabetic treatment regimen. The TRACE Study Group. Eur Heart J. 2000
Dec;21(23):1937-43.
10) Action to Control Cardiovascular Risk
in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse
JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG,
Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med.
2008 Jun 12;358(24):2545-59.
11) ADVANCE Collaborative Group, Patel A,
MacMahon S, Chalmers J, Neal B, Billot L,
Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L,
Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE,
Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with
type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72.
12) Duckworth W, Abraira C, Moritz T, Reda
D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S,
McCarren M, Vitek ME, Henderson WG, Huang GD; the VADT Investigators. Glucose Control and
Vascular Complications in Veterans with Type 2 Diabetes. N Engl J Med. 2008 Dec 17.
13) BMJ 2008;336:407,
doi:10.1136/bmj.39496.527384.DB
14) Bulletin of the World Health
Organization 80:952-958.
http://www.who.int/bulletin/archives/80(12)952.pdf
15) Rabinowitch I. Experiences with a high
carbohydrate-low calorie diet for the treatment of diabetes mellitus. Can Med Assoc J
23:489, 1930)
16) Kiehm T. Beneficial effects of a high
carbohydrate, high fiber diet on hyperglycemic
diabetic men. Am J Clin Nutr 29:895, 1976.
17) Singh I. Low-fat diet and therapeutic
doses of insulin in diabetes mellitus. Lancet 1:422, 1955.
18) Barnard R. Response of
non-insulin-dependent diabetic patients to an intensive program of diet and exercise.
Diabetes Care 5:370, 1982.
19) Barnard ND, Cohen J, Jenkins DJ,
Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet
improves glycemic control and cardiovascular risk factors in a randomized clinical trial
in individuals with type 2 diabetes.?Diabetes Care. 2006 Aug;29(8):1777-83.
20) Barnard ND, Gloede L, Cohen J, Jenkins
DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater
macronutrient changes, but is comparable in adherence and acceptability, compared with a
more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc.
2009 Feb;109(2):263-72.
21) Dashti HM, Mathew TC, Khadada M,
Al-Mousawi M, Talib H, Asfar SK, Behbahani AI,
Al-Zaid NS. Beneficial effects of ketogenic diet in obese diabetic subjects. Mol Cell
Biochem. 2007 Aug;302(1-2):249-56.
22) St. Jeor S, Howard B, Prewitt E.
Dietary protein and weight reduction. A statement for
health professionals from the Nutrition Committee of the Council on Nutrition, Physical
Activity, and Metabolism of the American Heart Association. Circulation 2001;104:1869-74.
23)
http://gov.ca.gov/pdf/press/Governors_HC_Proposal.pdf
24) California DHS, Fast Facts on Diabetes,
August 2003.
http://www.publichealthadvocacy.org/printable/CCPHA_RDiabetes.pdf
25)
http://news.ucanr.org/newsstorymain.cfm?story=875
