Generic drugs can save the consumer a lot of money. But some pharmaceutical manufacturers work aggressively to keep their market for a drug that goes off patent, limiting the availability of the generic brand. Here’s an example.
The term “generic drug” usually refers to a drug that has come off patent and is manufactured by one or more generic-drug companies in addition to the company that originally held the patent. Most generic drugs reach the market when the manufacturer’s patent on the product lapses. This is good news for consumers, because generics are less expensive than the brand-name drug but provide the same medical benefit. For instance, in 2006 the anticholesterol drugs pravastatin [Pravachol] and simvastatin [Zocor] went generic, offering people who switched to the generic form a savings of about 20% for the former and 10% for the latter, judging from the prices quoted on Drugstore.com. This is not good news for the original manufacturers, which lose the exclusive right to market a brand-name product.
An interesting article reported in The New England Journal of Medicine (Volume 355, page 1297) shows just how far big pharma will go to protect its interests. This article explains that an executive at pharmaceutical manufacturer Bristol-Myers Squibb agreed to make a secret cash payment of $40 million to Apotex, a Canadian generic drug company, to maintain its monopoly over sales of clopidogrel (Plavix) until 2011.
Plavix, a top-selling drug for preventing heart attacks and strokes, costs $4 per day. The generic would cost 20% less. In the end, the deal fell through and came under investigation by the U.S. Department of Justice, although a court injunction temporarily halted marketing of the generic version.
Such secret deals to keep cheaper generic drugs off the market are not uncommon, says an editorial in The New England Journal of Medicine. Manufacturers invent new drugs and take out multiple patents to protect their exclusive right to market them. When the patents start to expire, generic manufacturers often face years of legal battles to win the right to sell the drug. As a result, these companies may turn to special deals to avoid litigation. The generic manufacturer makes money by not selling its product. The brand-name company makes money by keeping its exclusive market for a while. Patients seldom know that they have lost money in the bargain.
Posted in Prescription Drugs on January 15, 2008
January 19th, 2008
Rebecca M. Woodward, PhD, a former research associate at Harvard University, used US government data to calculate the life expectancy of patients after they received a diagnosis of lung cancer. She and her colleagues combined survival data with information from the government’s Continuous Medicare History Sample File to calculate lifetime treatment costs.
Over the 15 year period between 1983 and 1997, the life expectancy for older NSCLC (non-small cell lung cancer) patients improved by an average of 0.6 months, or just 18 days. But the cost of treating such patients skyrocketed by $20,157 per patient. Medical economists judge the cost-effectiveness of a treatment by the standard yardstick of how much money it would take to increase survival by one year. The cost of treating lung cancer in this patient population comes to $403,142 per life-year. The more advanced the cancer, the more expensive each day or week of increased survival. Specifically, it costs $143,614 per life-year for localized lung cancer, $145,861 for regional lung cancer and a whopping $1,190,322 for metastatic NSCLC. Almost all the 18 days of extra survival achieved between 1983 and 1997 occurred in patients with localized cancer.
Cigarette smoking is of course the major cause of non-small cell lung cancer. Smoking cessation programs have an average price tag (in 1995 dollars) of $2,587 per life-year saved. Thus, preventing lung cancer is more than 100 times more cost effective than treating it! (Cromwell 1997)
Rebecca Woodward and her colleagues believe that the treatment of lung cancer should be reevaluated. “Given the number of patients affected and dollar values involved, a clear analysis and frank discussion of what has transpired in the big picture of cancer care is necessary to establish the background for our medical, political and economic discussions. Our results indicate that marked improvement has not occurred to date in the case of spending on non-small cell lung cancer treatment for those aged 65 and older,” Dr. Woodward said.
The researchers also said caution should be used before encouraging more intensive care for patients with lung cancer without considering the impact that such interventions might have in terms of the cost, and the potentially deleterious effect of treatment on patients’ quality of life.
Not everyone is ready for a frank discussion of chemotherapy’s failures, however. Some authors have commented that recent advances in treating lung cancer – particularly two FDA approved drugs, Iressa and Tarceva – have radically altered this picture by making the treatment of NSCLC more effective.
“Treatment and supportive care have dramatically improved, as witnessed by arriving at second- and third-line treatments,” Joseph Aisner, MD, chief medical officer at the Cancer Institute of New Jersey told the online journal, Hem/Onc Today (Brinson 2007).
But have these drugs really brought about a “dramatic improvement” in the treatment of lung cancer? In one clinical trial, the median survival in Tarceva-treated patients was 6.7 months compared with 4.7 months for patients in the placebo group; i.e., the actual gain in survival was 2 months. The time to pain progression was 2.79 months in the Tarceva-treated group vs. 1.91 months in the placebo group, a gain of about 3 weeks. And progression-free survival averaged 2.23 months in the Tarceva-treated group vs. 1.84 months in the placebo group, amounting to a gain of just 12 days. So at best we can expect that the addition of Tarceva may add an average of 2 months to the survival of patients with NSCLC, with a concomitant increase in adverse effects. (Whether the elderly population will respond in similar fashion remains to be seen.) As to Iressa, a 2004 clinical trial found “no added benefit” in survival when Iressa was compared to standard chemotherapy alone (Herbst 2004).
The failure of chemotherapy in NSCLC reminds us that there is still an urgent need for effective preventive strategies as well as for a vigorous exploration of non-conventional approaches to treating the disease.
The Moss Reports December 23, 2007
December 24th, 2007
By the end of the year it is predicted there will be more than 12 million new cancer cases and 7.6 million cancer deaths worldwide – that’s about 20,000 cancer deaths a day.
The estimates come from a new American Cancer Society report based on data from the International Agency for Research on Cancer. The report also estimates 5.4 million of those cancers and 2.9 million deaths will be in economically developed countries, while 6.7 million case and 4.7 million deaths will be in economically developing countries.
The research shows the three most commonly diagnosed cancers in men in developed countries are prostate, lung, and colorectal cancer; in women they are breast, colorectal, and lung cancer. But in developing countries the three most commonly diagnosed cancers in men are lung, stomach, and liver cancer; and in women they are cancers of the breast, cervix uteri, and stomach. Cancers of the stomach, liver, and cervix are related to infection in these countries.
About 15-percent of all cancers around the world are infection-related with a three times higher percentage in developing countries than in developed ones – 26 percent versus 8 percent.
“The burden of cancer is increasing in developing countries as deaths from infectious diseases and childhood mortality decline and more people live to older ages when cancer most frequently occurs,” study co-author Ahmedin Jemal, Ph.D., American Cancer Society, was quoted as saying. “This cancer burden is also increasing as people in the developing countries adopt western lifestyles such as cigarette smoking, higher consumption of saturated fat and calorie-dense foods, and reduced physical activity.”
In both developed and developing countries, the report shows the three most common cancer sites are also the three leading causes of deaths from cancer.
SOURCE: Global Cancer Facts & Figures, 2007
December 20th, 2007
Middle-aged women today are about half as likely as their counterparts 25 years ago to die from breast cancer, thanks in large part to the collective effects of modern therapies, according to new data reported at SABCS. Results of the 2005-2006 update of the worldwide overview presented by Richard Peto, PhD, on behalf of the Early Breast Cancer Trialists’ Collaborative Group were based on data from roughly 350,000 women and 400 randomized trials.
In the meta-analysis, radiation therapy after mastectomy with axillary nodal dissection conferred an absolute reduction of breast cancer mortality at 15 years of 7% to 8%. All-cause mortality was reduced 5% to 6% among women with positive nodes, according to Dr. Peto.
“If you do have nodal involvement, then really you do need to do something about treating the local area or at least consider doing so,” he said.
In contrast, among women with node-negative disease, this treatment increased all-cause mortality.
For women with oestrogen receptor (ER)-positive tumors, receipt of 5 years of tamoxifen conferred an absolute 9% reduction in 15-year breast cancer mortality without any significant effect on non-breast-cancer mortality. The curves further diverged during the decade after stopping tamoxifen, Dr. Peto said.
“It’s an extraordinary carryover effect — not just continuing what they’ve got, they’re gaining extra benefit,” he said.
Women with ER-positive disease had slightly lower 5-year breast cancer mortality if they received 5 years of an aromatase inhibitor, compared with 5 years of tamoxifen (6.5% vs. 7.4%).
“It’s not yet significant, but wait for the 2010 overview. Maybe it will be,” he said.
Finally, taking into account data on the relative benefits of CMF, anthracycline-based regimens, and taxane-based regimens, the risk of breast cancer mortality was reduced with taxane chemotherapy by one-half among women younger than age 50 (rate ratio, 0.46) and by one-third among women aged 50 to 69 (rate ratio, 0.66), Dr. Peto said.
“I’m not making any treatment recommendations,” he cautioned, noting that this chemotherapy is not without drawbacks. “Look at the prognosis, discuss the side effects, discuss the costs, and decide what to do.”
Dr. Peto concluded by underscoring the importance of continuing to collect long-term data.
“What we need is for these trials not to get lost. These are unique experiments, they are not going to be reported. We want 20-year follow-up out of these trials,” he said. “There will be a lot more to learn in the 2010 cycle of this collaboration.”
December 14th, 2007
1. gastric carcinoma
Huang Shen Capsule is a product originated from ancient formula Da Huang Zhe Chong Wan. Xu Angao et al. used Huang Shen Capsule (each capsule containing 19g extract from raw drugs) to treat stomach neoplasm. 30 cases in terminal stages of gastric carcinoma were treated. Among the patients, 21 cases were male, 9 female; 8 cases were after palliative operation, 13 were recurrent cases after operation, and 9 cases hadn’t taken any operation. The patients’ age ranged from 24 to 71 years old, averagely 58.25.7 years old. Treating method: Huang Shen Capsule, 3 capsules, tid, 4 weeks in succession. Gastroscopy was applied before and after the treatment in order to get the cancer sample to test the apoptosis index and nitric oxide. Venous blood and gastric juice were also sampled to measure the nitric oxide level. Evaluate the improvement of the clinical symptoms according to Karnofsky standard. The results showed that the grade of the behavior after treatment was significantly higher than that before treatment (P<0.05); the cell apoptosis indices of the 30 cases before and after treatment were 5.9%1.4% and 12.94.3% respectively (P<0.05); and the nitric oxide levels of the blood serum, gastric juice and gastric carcinoma tissues after treatment were significantly higher than those before treatment (P<0.01).
––Xu Angao, et al. Mechanism research on cell apoptosis and nitric oxide in treating gastric carcinoma with Huang Shen Capsule. Journal of digestion of global Chinese, 1999: 7(4).
2. liver cancer
Wang Xiaoxian applied the drugs of “activating Blood and removing Blood stasis” in treating liver cancer of middle and terminal stages since 1995, satisfactory effects were obtained. In this report, 15 cases of liver cancer were randomly divided into treating group of activating Blood and removing Blood stasis, and control group of chemotherapy. There’re 8 cases in the treating group, 6 of them were male, 2 female, age ranging from 35~72 years old, averagely 63 years old; in the 7 cases of control group, 5 were male and 2 female, age ranging from 41~69 years old, averagely 58 years old. Treating methods for treating group: dang gui 25g; chi shao, chai hu, fu ling, bai zhu, san leng, e zhu, bie jia, xiang fu, shou wu and xuan hu, 10g each; ban zhi lian, bai hua she she cao 20g each; sheng pu pang, dan shen, huang qi 15g each. All drugs were decocted in water, extracted 400ml juice, which would be taken once in the morning and once in the evening. Cases of the control group were treated with interventional chemotherapy through the hepatic artery (MFP). Results: in the treated group, 4 cases were markedly effective, 3 effective, 1 ineffective, the total effective rate was 87.5%; in the control group, 2 markedly effective, 2 effective, 3 ineffective, the total effective rate was 57.1%. There’s significant statistical difference between them (P<0.05).
––Wang Xiaoxian. Discussion on application of “activating Blood and removing Blood stasis” in anti-liver cancer. Clinical research and report, 1999: 1(3).
3. nasopharygeal cancer
Yi Qi Jie Du Pian, also known as Compound Huang Lian, is a product made from huang lian, huang qi, bai hua she she cao, etc.. It’s known from previous research that this product can kill nasopharygeal cancer (NPC) cell strain HNE1, and has strong inhibitory effect over NPC cell transplantation tumors on nude mice. In this research, Shen Qi, et al. used MTT method to explore the killing effects of peripheral blood monocytes over Raji cells, and immune enzyme method to explore the immunoblocking function of EBV VCA-IgA. Results showed that on one hand, Yi Qi Jie Du Pian could kill Raji cells directly; on the other hand, it could relieve the immunoblocking function of EBV VCA-IgA, so that immunocytes could directly kill the Raji cells which brought EBV genes. The research indicated that Yi Qi Jie Du Pian may relieve the immunoblocking function of EBV VCA-IgA so as to block the development of NPC in people at high risk of the disease.
––Shen Qi, et al. Initial research on relieving effects of Yi Qi Jie Du Pain over immunoblocking function of EB virus VCA-IgA. Research on formulas and drugs, 1999: 19(1).
4. lung cancer
This paper observed the effects of traditional Chinese herbs on chemotherapy sensitivity and toxicity of chemotherapy. A study-control trial in 235 patients with lung cancer in Shandong Institute of Preventing and Treating Tumor from 1994 to 1997 were performed.139 patients of study group were treated with Chinese herb medicine plus combined chemotherapy, 96 patients of control group were treated with combined chemotherapy alone. Results: the difference of effective rates between trial group and control group was obvious (P<0.05), and the toxicities of chemotherapy on digestive duct, bone marrow and liver in trial group were less than those in control group (P<0.01). The results indicated that Chinese herb medicine could not only prevent the side effects of chemotherapy of lung cancer but also enhance the effect of chemotherapy.
––Xiao Jun, et al. Observation of the effects of traditional Chinese herbs on chemotherapy sensitivity and toxicity of lung cancer, with analysis of 235 cases. Basic and clinical research, 1999: 6(1).
December 11th, 2007
A common household chemical to is connected to breast development. The research focused on butyl benzyl phthalate (BBP). BBP is a plasticizer and is found in household items such as pipes, vinyl floor tiles and carpet backing.
Investigators from Fox Chase Cancer Center in Philadelphia and the University of Alabama in Birmingham fed lactating rats BBP and then their offspring absorbed it via breast milk. The offspring ingested a level of BBP that is equivalent to the Environmental Protection Agency’s safe dose limit.
Researcher report the female offspring had changes happen because of the BBP. Specifically, it affected the development of the mammary gland in rats. Study authors say the changes wore off once the BBP exposure was stopped, but they say the changes in the mammary gland could have effects later in life.
They say this type of chemical is an endocrine disruptor, which mimics the effect of hormones. Study authors say more research is needed to see if the presence of BBP could lead to breast cancer.
December 7th, 2007
Ageing is a disease I don’t wish to be cured of… from the movie ‘Citizen Kain”
Of all the causes of cancer, ageing seems the most prevalent. However, getting older is not the same as ageing. Ageing is a catabolic process, that is it is a breakdown of the system – it is the opposite of growing. Perhaps we should not say growing old but falling old.
Is cancer inevitable? Not according to a recent meta-analysis of data. Cancer is not a fate but a choice based upon lifestyle. While about 20% of cancer have a genetic bases, what we do with diet, exercise and stress will turn a gene ‘on’ or ‘off’.
November 28th, 2007
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November 12th, 2007
Prevalence of Colorectal Neoplasm Among Patients With Newly Diagnosed Coronary Artery Disease
Annie On On Chan, MD, PhD; Man Hong Jim, MD; Kwok Fai Lam, PhD; Jeffrey S. Morris, PhD; David Chun Wah Siu, MD; Teresa Tong, BSc; Fook Hong Ng, MD; Siu Yin Wong, MD; Wai Mo Hui, MD; Chi Kuen Chan, MD; Kam Chuen Lai, MD; Ting Kin Cheung, MD; Pierre Chan, MD; Grace Wong, MD; Man Fung Yuen, MD, PhD; Yuk Kong Lau, MD; Stephen Lee, MD; Ming Leung Szeto, MD; Benjamin C. Y. Wong, MD, PhD; Shiu Kum Lam, MD
JAMA. 2007;298:1412-1419.
Context Colorectal neoplasm and coronary artery disease (CAD) share similar risk factors, and their co-occurrence may be associated.
Objectives To investigate the prevalence of colorectal neoplasm in patients with CAD in a cross-sectional study and to identify the predisposing factors for the association of the 2 diseases.
Design, Setting, and Participants Patients in Hong Kong, China, were recruited for screening colonoscopy after undergoing coronary angiography for suspected CAD during November 2004 to June 2006. Presence of CAD (n = 206) was defined as at least 50% diameter stenosis in any 1 of the major coronary arteries; otherwise, patients were considered CAD-negative (n = 208). An age- and sex-matched control group was recruited from the general population (n = 207). Patients were excluded for use of aspirin or statins, personal history of colonic disease, or colonoscopy in the past 10 years.
Main Outcome Measures The prevalence of colorectal neoplasm in CAD-positive, CAD-negative, and general population participants was determined. Bivariate logistic regression was performed to study the association between colorectal neoplasm and CAD and to identify risk factors for the association of the 2 diseases after adjusting for age and sex.
Results The prevalence of colorectal neoplasm in the CAD-positive, CAD-negative, and general population groups was 34.0%, 18.8%, and 20.8% (P < .001 by ?2 test), prevalence of advanced lesions was 18.4%, 8.7%, and 5.8% (P < .001), and prevalence of cancer was 4.4%, 0.5%, and 1.4% (P = .02), respectively. Fifty percent of the cancers in CAD-positive participants were early stage. After adjusting for age and sex, an association still existed between colorectal neoplasm and presence of CAD (odds ratio [OR], 1.88; 95% confidence interval [CI], 1.25-2.70; P = .002) and between advanced lesions and presence of CAD (OR, 2.51; 95% CI, 1.43-4.35; P = .001). The metabolic syndrome (OR, 5.99; 95% CI, 1.43-27.94; P = .02) and history of smoking (OR, 4.74; 95% CI, 1.38-18.92; P = .02) were independent factors for the association of advanced colonic lesions and CAD.
Conclusions In this study population undergoing coronary angiography, the prevalence of colorectal neoplasm was greater in patients with CAD. The association between the presence of advanced colonic lesions and CAD was stronger in persons with the metabolic syndrome and a history of smoking.
Prevalence of Colorectal Neoplasm Among Patients With Newly Diagnosed Coronary Artery Disease
Annie On On Chan, MD, PhD; Man Hong Jim, MD; Kwok Fai Lam, PhD; Jeffrey S. Morris, PhD; David Chun Wah Siu, MD; Teresa Tong, BSc; Fook Hong Ng, MD; Siu Yin Wong, MD; Wai Mo Hui, MD; Chi Kuen Chan, MD; Kam Chuen Lai, MD; Ting Kin Cheung, MD; Pierre Chan, MD; Grace Wong, MD; Man Fung Yuen, MD, PhD; Yuk Kong Lau, MD; Stephen Lee, MD; Ming Leung Szeto, MD; Benjamin C. Y. Wong, MD, PhD; Shiu Kum Lam, MD
JAMA. 2007;298:1412-1419.
Context Colorectal neoplasm and coronary artery disease (CAD) share similar risk factors, and their co-occurrence may be associated.
Objectives To investigate the prevalence of colorectal neoplasm in patients with CAD in a cross-sectional study and to identify the predisposing factors for the association of the 2 diseases.
Design, Setting, and Participants Patients in Hong Kong, China, were recruited for screening colonoscopy after undergoing coronary angiography for suspected CAD during November 2004 to June 2006. Presence of CAD (n = 206) was defined as at least 50% diameter stenosis in any 1 of the major coronary arteries; otherwise, patients were considered CAD-negative (n = 208). An age- and sex-matched control group was recruited from the general population (n = 207). Patients were excluded for use of aspirin or statins, personal history of colonic disease, or colonoscopy in the past 10 years.
Main Outcome Measures The prevalence of colorectal neoplasm in CAD-positive, CAD-negative, and general population participants was determined. Bivariate logistic regression was performed to study the association between colorectal neoplasm and CAD and to identify risk factors for the association of the 2 diseases after adjusting for age and sex.
Results The prevalence of colorectal neoplasm in the CAD-positive, CAD-negative, and general population groups was 34.0%, 18.8%, and 20.8% (P < .001 by 
2 test), prevalence of advanced lesions was 18.4%, 8.7%, and 5.8% (P < .001), and prevalence of cancer was 4.4%, 0.5%, and 1.4% (P = .02), respectively. Fifty percent of the cancers in CAD-positive participants were early stage. After adjusting for age and sex, an association still existed between colorectal neoplasm and presence of CAD (odds ratio [OR], 1.88; 95% confidence interval [CI], 1.25-2.70; P = .002) and between advanced lesions and presence of CAD (OR, 2.51; 95% CI, 1.43-4.35; P = .001). The metabolic syndrome (OR, 5.99; 95% CI, 1.43-27.94; P = .02) and history of smoking (OR, 4.74; 95% CI, 1.38-18.92; P = .02) were independent factors for the association of advanced colonic lesions and CAD.
Conclusions In this study population undergoing coronary angiography, the prevalence of colorectal neoplasm was greater in patients with CAD. The association between the presence of advanced colonic lesions and CAD was stronger in persons with the metabolic syndrome and a history of smoking.
September 27th, 2007
The art of medicine has two aspects, correct diagnosis and correct prescribing. The next most critical factor is how to combine various compounds to enhance treatment. Wrong combinations can undo a good treatment while good combining enhances and creates an effect greater than the sum of the parts.
Most therapeutic products combine well with any of the antioxidants such as Resveratrol, EGCG, CoQ10’ SeaBuckthorn oil and Re) Joovina. We generally suggest cycling antioxidants to enhance their individual characteristics ie Resveratrol from 1 to 14 days, introducing another such as EGCG at the 7th day continuing until the 21st day and introducing a third antioxidant like CoQ10 at day 14, etc.
Re) Joovina, which contains R Lipoic acid and Acetyl L-Carnitine can be used continually as R Lipoic acid is a bi-directional antioxidant which recycles other antioxidants and acetyl L-Carnitine is a stimulant to the cell’s mitochondria.
Curcumin and Quercetin is particular useful as a mild general antiinflammatory for those consuming alcohol and grilled meats and/or fried foods.
Advanced Inflammation Control is a useful for chronic inflammatory conditions due to environmental toxicity and can be used with other more specific compounds.
A regular use of a de-tox formula is important. Cool Blue, LivoClear, Gut Clear or Gastro Clear should be used for liver, gut, and gastric and systemic toxification. Lectin Control is an important adjunct to nearly every therapeutic regime from weight loss to cancer to chronic degenerative diseases. Don’t forget to follow up with Gut Restore to enhance good gut flora. Don’t forget SeaBuckthorn Oil repairs sensitive gut, respiratory and urinary tissues.
Remember, when combining various compounds it is a good idea to reduce dosages about 20 to 30% to factor the synergistic effects. Remember, combining is one of the highest arts in medical prescribing and you will get better results, faster.
September 26th, 2007
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