Tough times ahead for big pharma?
Currently it’s the financial industry that is in trouble. Will the pharmaceutical industry be next? This could well be according to business analysts, in a recent report in the Financial Times.
The reasons for the bad prognosis are expiration of patents coinciding with shrinking pipelines and increasing competition from generics. Furthermore, the counterstrategy of mergers and acquisition isn’t seems to be working as expected.
Meanwhile, drug regulations are getting tighter. Alternative medicine, dietary supplements, and homeopathic medications are conquering the market while biotechnology and stem cell research are not delivering the promised blockbuster therapies everybody is hoping for.
In 2007, Roche outperformed for the first time its Swiss archival Novartis in earnings. However, even Roche delivered lower than expected results in the first quarter of 2008 due to decreasing demand for Tamiflu.
Other drug companies are expecting tough times as the patent of their blockblusters are about to expire. GSK’s Lamictal goes off patent this year and Pfizer’s Lipitor in 2010. Other best-selling drugs whose patents are due to expire are Johnson & Johnson’s Risperdal, Astra Zeneca’s Seroquel and GSK’s Avandia, according to FT.
Decades-old artificial heart valves still going strong
Two video clips of two Starr-Edwards artificial valves can be seen in action in this week’s online issue of the New England Journal of Medicine. The video was taken by doctors at the Montreal Heart Institute in Quebec during a cardiac catheterization procedure of a 67-year old woman. What is amazing is the fact that these valves, which are working properly and in tip top shape, were implanted 38 years ago [1].
In another case study, a 74-year old man had a double valve replacement with Smeloff-Cutter aortic and Starr-Edwards mitral prostheses 40 years ago. No additional surgery except a pacemaker implantation has been required during the last 4 decades. The latest ECG showed the valves to be intact [2].
Other follow-up studies indicate that the Starr-Edwards valve “represents a standard that still needs to be achieved by newer prostheses.” [3]
This is the lasting legacy of the retired engineer Lowell Edwards who, together with the surgeon Albert Starr, developed the valves almost 50 years ago. The first valve was successfully implanted in 1960. Edwards then founded Edwards Lifesciences, which today remains as one of the world’s leading manufacturer of medical devices. According to Nature News,, over a quarter of a million people received Starr-Edwards artificial valves until last year when the company stopped their manufacturing in favour of newer models.
Lowell Edwards was awarded the American Medical Association’s Layman’s Citation for Distinguished Service in 1982, only the 6th person so far to receive the honor. The citation described the innovator as
“a man of honor and courage whose inventive genius brought about the development of the artificial heart valve and whose long devotion to human welfare in the science of medicine has given new life and hope to victims of heart disease throughout the world.”
References:
1. Piazza N, Gregoire J. Images in clinical medicines. Starr-Edwards heart valves. N Engl J Med. 2008 May 22;358(21):e24.
2. Gödje OL et al. Thirty-year results of Starr-Edwards prostheses in the aortic and mitral position. Ann Thorac Surg. 1997 Mar;63(3):613-9.
3. Suezawa T et al. Forty-year survival with Smeloff-Cutter and Starr-Edwards prostheses. Ann Thorac Surg. 2008 Mar;85(3):e14-6.
Stem cells in the most unexpected places
Time was when pleuripotent stem cells were supposedly only available from human embryos which led to heated debates on ethics and morality.
Since then, multipotent stem cells have been isolated from different organs of the human body, be it from the umbilical cord blood, the bone marrow, even from the skin. Recent research studies have now pinpointed even more unexpected sources of stem cells.
Stem cells in menstrual blood [1, 2]
Researchers at the University Pittsburgh’s McGowan Institute of Regenerative Medicine observed that menstrual blood stromal cells (MenSCs) exhibit a great capacity for self-renewal and multipotency.
Stem cells in breast milk [3]
On the other side of the globe, researchers at the University of Western Australia recovered the stem cell markers nestin from breast milk. These cells physically resemble stem cells and could potentially behave like stem cells.
If nestin and MenSCs indeed prove to be as plastic and pleuripotent as embryonic stem cells, then, we may have found stem cell sources which are unlimited, inexpensive, most of all, noncontroversial. Furthermore, these cells are easily collectable without resorting to invasive techniques.
Sources:
- Eureka Alert, 23 April 2008
- Patel et al. Cell Transplantation 2008; 17: 303-311
- Science Alert, 10 February 2008
Reinventing chocolate: the dark-and-sweet side of clinical trials
More and more evidence are piling up on the health benefits of dark chocolate. Cocoa is rich in flavonoids which have potent antioxidant properties. No wonder that the biggest chocolate manufacturers are scrambling to grab this opportunity to reinvent chocolate from being the number one enemy of weight watchers, diabetics and heart patients to be the next “wonder health food” or dietary supplement that might even surpass soy and omega-3`s in terms of popularity. And no wonder that people are scrambling to volunteer to participate in chocolate clinical trials, free of charge. Given below are overviews of some trials on chocolates, past, present, and future.
Successful trials whose results have been published: [1,2]
This “randomized, controlled, investigator-blinded, parallel-group trial” investigated the effect of chocolate consumption (6.3 g of dark chocolate per day = 30 kcal) on the blood pressure of prehypertensive adults. “From baseline to 18 weeks, dark-chocolate intake reduced mean systolic BP by 2.9 mm Hg (p<0.001) and diastolic BP by 1.9 mm Hg (p<0.001) without changes in body weight, lipids, glucose, or 8-isoprostane. Hypertension prevalence decreased from 86% to 68%.”
In this double-blind randomized study, Swiss researchers at the Zurich University Hospital studied the effect of dark chocolate in 22 heart transplant patients. An intake of 40 g of dark chocolate (70% cocoa) “induces coronary vasodilation, improves coronary vascular function, and decreases platelet adhesion 2 hours after consumption. These immediate beneficial effects were paralleled by a significant reduction of serum oxidative stress and were positively correlated with changes in serum epicatechin concentration.”
The not so-successful: [3]
The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed as a double-blinded clinical trial “to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness.” However, data analysis somehow went awry because “many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.”
This one is ongoing:
The Phase I trial on the “Effects of Dark Chocolate on Insulin Sensitivity in People with High Blood Pressure” (ClinicalTrials.gov Identifier: NCT00099476) examines “whether dark chocolate affects the way patients with hypertension (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective in helping the body use glucose. This is called insulin resistance. Insulin also increases blood flow into muscle by opening inactive blood vessels. Laboratory studies suggest that eating dark chocolate may improve blood pressure. This study will determine whether dark chocolate improves insulin resistance or changes how blood vessels react to insulin in hypertensive people.”
This one is still recruiting:
This trial, due to start in June, will investigate whether flavonoids found in chocolate and other foods can reduce the risk of cardiovascular diseases in menopausal women with type 2 diabetes. “The study is funded by … Diabetes UK, and is led by a team at the University of East Anglia (UEA) in Norwich, partnered by the Elsie Bertram Diabetes Centre, Norfolk, Norwich University Hospital (NNUH) and the Institute of Food Research (IFR).”
References:
1. Taubert D, Roesen R, Lehmann C, et al. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide. A randomized controlled trial. JAMA 2007; 298:49-60
2. Flammer A, Hermann F, Sudano I, et al. Dark chocolate improves coronary vasomotion and reduces platelet reactivity. Circulation 2007;116:2376-2382.
3. Chan, K. A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study. CMAJ 2007; 177 (12).