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As I’ve commented many times before, Airborne is just an unsafe product and furthermore, their claims are highly inaccurate. Airborne was sued with a class action suit in California courts for having deceptive advertising and among which it claimed to have a clinical trial on the efficacy of its product. The clinical trial turned out to be fraudulent. The courts claim that theirs was “a fraud scheme alleged to have cost consumers hundreds of millions of dollars.”
They settled out of court Wednesday for $23.3 million dollars. Attorneys on the state side are still going forward with charges, stating that the settlement does not include statues that Airborne must stop their fraudulent advertising. Airborne faces similar litigations in New Jersey federal court.
File for a refund here (you don’t need to have a receipt)
It looks like Merck find themselves in court once again. On January 17, Merck and Schering-Plough are listed as defendants in a class action suit which charges them with fraud and misrepresentation for withholding a study that could be damaging to their drug – Vytorin.
Vytorin (Simvastatin and Ezetimibe), a cholesterol lowering agent, is a joint venture between the two companies, with Merck contributing the drug simvastatin and Schering-Plough contributing Ezetimibe.
The clinical trial in question is called the ENHANCE study. The trial began in June of 2002 and looked at 720 patient who has a genetic disorder which gave them high blood cholesterols. This population is different from the majority of people who are high blood cholesterol who may have a genetic disposition to have high cholesterol, but are more of a result of age and diet.
It was recently discovered that the ENHANCE trial showed that Vytorin did not decrease blood cholesterol more effectively than simvastatin alone and additionally, Vytorin may cause MORE atherosclerotic plaque build-up in the blood vessel than through using simvastatin alone. The rub about this information is that the first part is shown to be statistically significant and the latter point has not shown to be statistically significant (p=0.28).
The ENHANCE trial was first expected to be release in November of 2006 but the companies delay the release until March of 2007 and then again until March of 2008 and at which point the company tried to change the original endpoint of the study and when the FDA took up the investigation.
The companies had foretold that if this research gets out, it would undermine the sale of Vytorin. I personally, don’t think the plaintiffs in this case will be victorious unless they fall into this small population of patients whose high blood cholesterol is caused by their genetics. But through the poor handling of this situation and the public reading poor interpretations of the ENHANCE trial, their reputation and the reputation of Vytorin will be significantly smeared.
I do not recommend that anybody stop taking their prescribed therapy until speaking with their primary care physician.
Stocks of both companies fell today after the news.
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On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.
Evicel is manufactured by OMRIX biopharmaceuticals LTD (located in Kiryat Ono, Israel) and marketed by .
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In a study published January 16th, in the British Medial Journal (BMJ) [equivalent to our New England Journal of Medicine (ENJM)] found that postmenopausal women receiving extra-dietary supplements may be at increased risk of myocardial infarction, stroke and sudden death.
The study was down out of the University of Auckland, New Zealand. They looked at data from a research done on 1,471 postmenopausal women over the age of 55 (average age 74) randomized into a placebo and calcium supplement arm to look at calcium supplement’s effect on bone fracture. The study followed the medical history of these women over five years.
The results showed that:
- Reports of myocardial infarction (heart attack) were significantly higher in the calcium group than in the placebo group (45 events in 31 women versus 19 events in 14 women).
- The occurrence of any three vascular events, myocardial infarction, stroke, or sudden death was also significantly more common in the calcium group (101 events in 69 women versus 54 events in 42 women).
- Because the results were so important, the researchers went back and checked hospital records and death certificates to look for any unreported events.
- After adjusting the figures for the newly found and previously unreported events, they discovered that myocardial infarction (heart attack) was still more common in the calcium group (36 events in 31 women versus 22 events in 21 women on placebo).
- The figures for heart attack, stroke or sudden death also went up in the calcium group (76 events in 60 women versus 54 events in 50 women on placebo) but were shown to have borderline significance.
The researchers concluded that:
“Calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates.”
However they cautioned against rash treatment decisions by saying that:
“This potentially detrimental effect should be balanced against the likely benefits of calcium on bone.” This was particularly important in the case of elderly women they said.
You can read the whole article at BMJ.
So what does all this information mean? There are experts out there who have came out publicly saying that this data is a fluke and should be disregarded. I don’t think this view point is wise to judge the data so harshly, one way or the other. Clearly this data is unnerving, especially when it goes against the commonly recognized practices in medicine, but this data is significant and should be treated with care. In my opinion, something like this should call for is more researchers to look into the problem. A retrospective analysis could quickly be done on previous data done on this patient population.
The women in the study specifically took Citracal (Mission Pharm., San Antonio, TX) perhaps it is this specific formulation that is causing the adverse results, we just don’t know.
If you’re a patient currently on calcium supplement therapy, I would recommend printing out the article and making an appointment with your doctor to discuss your particular situation before making any therapy changes.
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Benefits Check-Up
Free, useful service that lists federal and state assistance programs for older Americans. It was the answer to address the problem of older adults being eligible for benefits and yet not utilizing them. Millions of older Americans may benefit from public programs that offer such things as health coverage, supplemental income and utility bill assistance.
PhRMA
Provides updated lists of patient assistance program directory
Needy Meds
Similar format to RXAssist in that the site provides a catalog of available programs listed according to drug name and manufacturer
Shoot-up to stay drug-free – the promise by Drs. Tom and Therese Kosten, the husband and wife team, researchers at the Baylor College of Medicine, who’ve developed a cocaine vaccine.
According to the Houston Chronicle, the Kostens have been working on the cocaine vaccine for the last decade. The idea behind the concept is to inject a modified cocaine molecule into the body to stimulate the immune system. After the immune system recognizes the cocaine molecule, subsequent exposure to the cocaine molecule will stimulate the immune system to destroy the molecule before it is able to mount its activity on the brain. The reason that the cocaine molecule evades the immune system is because it is too small to be recognized. The Kostens have created a molecule large enough to stimulate the immune system.
It’s a brilliant idea and it is working. From Phase 2 clinical trials, the Kostens found that addicts who receive their vaccine on average use 50% less than they did previously. They are currently waiting approval by the FDA to start Phase 3 clinical trials where they will enroll 300 addicts in their cocaine withdrawal program that will include vaccine therapy and psychological counseling.
There are many ethical issues being put on the table in regards to the vaccine’s use. Although it may be a great tool to stop cocaine addiction, the concern is whether or not it is ethical to give the vaccine to children in an attempt to steer-head their use of the drugs before it even occurs?
[the structure on the left :: Hyoscyamine; right :: Cocaine]
My concern is the medical safety of this vaccine. Cocaine is a small molecule that has chemical properties as well as structures similar to those molecules that naturally occur in the body. In the above figure, one can visually see that cocaine is a very similar in structure to the drug hyoscyamine. Hyoscyamine is used to calm intestinal spasms. What will happen when we create an immune system that looks after similar molecules? Yes, it does destroy the cocaine molecule when it sees it, but does it also destroy drugs with similar structure or naturally occurring molecules in the body with a similar structure?
That being said, it is wise to note that there are over 22 million cocaine users in the United States, costing the US population nearly half a trillion dollars annually. In the end, I’d to take a quote from Dr. Peter Cohen, a Georgetown law professor and chairman of the District of Columbia Medical Society’s physician health committee: “Overall, the benefits to society of such vaccines would outweigh the risks. There are certainly important issues there, but I don’t think any are insurmountable.”
American Diabetes Association (ADA)
This is as “must” source for newly diagnosed diabetics or those wishing to learn more about their condition. The site has sections for those who were recently diagnosed, those with Type 1, or Type 2 Diabetes along with an “Ask the Pharmacist” area. The ADA also supplies a newsletter that diabetics may subscribe to in order to receive news and events occurring in the world of diabetes.
For a much more interactive presentation on Diabetes provided by the ADA, users may watch Link for Life. Also available is a Diabetes Risk Test.
Not all glucometers work the same way and the importance of measuring ones blood glucose cannot be stressed enough. For those who need more help in learning to use your meter, please check this link. According to the FDA, it lists the Diabetes Education programs recognized by the American Diabetes Association. These Recognized programs meet the National Standards for excellence in diabetes education.
Diabetes Research and Wellness
This is a non-profit organization that offers free diabetic resources including free a pocket diary, diabetes identification card and diabetes necklace. The necklace will alert healthcare providers about your condition before they treat you.
Drug Companies Diabetes Resource Sites
Drug companies offer online diabetic tools for diabetics and especially for those patients who are using their meters.
Novo-Nordisk: Diabetic management features such as a diabetes care plan, menu planning tools, and stories written by patients on ways to live with diabetes
BD Diabetes: Provides flash-based patient education animations on how to draw, mix, and inject insulin. It even has a section for diabetes and pets.
Health 2.0 Sites
MySugarLevel
Tracking sugar site that charges users for access. Allows users to track and monitor sugar levels.
SugarStats
Site that allows you to monitor your suguar levels along with your foods. It provides users with graphs and trends.
TuDiabetes
Community for those affected by Diabetes. The site contains social networking features such as blogging, adding friends, and groups.
dLife
Diabetes resource that contains Q&A with experts, recipes, the “Wall”, and blood sugar management, among others.
Other related:
Johnson and Johnson’s Tour de Cure
The FDA recently (Dec 12, 2007) approved ProDisc-C for cervical vertebra use. They first approved ProDisc-L for lumbar-vertebra use in Aug 2006.
ProDisc was designed in the late 1980’s by a French Spinal Orthopedic Surgeon name Thierry Marnay. Marnay implanted this artificial disc into 64 patients in the early 90s and almost a decade later these patients were studied to determine the long-term results of implantation. Three patients had died from unrelated causes, but the remaining 58 were studied extensively at 7-11 year follow-ups. All implants were intact and functioning. There had been no implant removals, revisions, or failures.
There was no evidence of subsidence (sinking or settling in bone) on follow-up radiographs compared to the peri-operative films, as reported by the operating surgeon as well as by an independent US Orthopaedic spine surgeon.
A significant (99.99% confidence) reduction in patient-reported back pain and leg pain was identified. 92.7% of these patients were “satisfied” or “extremely satisfied” with the procedure.
Two-thirds of these patients had single vertebra implants while one-third had two vertebra replaced. There was no outcome difference between the 1 and 2 level ProDisc implantations.
During follow up, there were no device-related safety issues, no untoward effects, no complications and no adverse events.
ProDisc is made of metal endplates made of a cobalt chromium molybdenum alloy (CoCrMo). The convex bearing surface, snap-fit into the inferior end plate, is made of ultra-high molecular weight polyethylene (UHMWPE). The artificial disc is attached through a large central keel and two spikes on each endplate. Physiologically, the ProDisc matches the range of motion in flexion, extension, axial rotation, and lateral bending as a normal spine.
From these positive results, the ProDisc has been implanted in over 8000 patients in Europe since December 1999. A multicenter FDA study was started in the United States in October 2001. The first ProDisc in the United States was implanted at the Texas Back Institute on October 3, 2001. Nineteen study centers participated in the prospective randomized study, comparing the ProDisc to the current standard treatment of a 360° (front and back) fusion using allograft in the intervertebral space and pedicle screws with autograft posteriorly.
ProDisc is the only one of the artificial discs undergoing FDA trials that is being investigated for multiple level lumbar disc disease. Other disc replacement devices include: Maverick, Flexicore, Kineflex.
The two level study arm completed enrollment in November 2003. Continued Access in this arm began in January 2004, where a limited number of patients may be treated at study sites with two-level ProDisc surgery as long as they meet the original study criteria, and continue follow-up for collection of safety data.
Thanks for the input and collaborations with Dr. Sue Snyder.
As covered in a story from Venture Beat and from their own press release, Cogentus Pharmaceuticals of Menlo Park, CA just received $62.5 million in third round funding for their combination drug of clopidogrel (an anti-platelet) and omeprazole (a proton pump inhibitor). The idea behind this combination is omeprazole will help with the gastro-intestinal side effects of clopidogrel, a “blood thinner.” Both of these drugs have recently gone off patent and can be reproduced cheaply.
Convention would suggest that a doctor would not prescribe a combo-drug when two generics are cheaper for the patient. However, the market proves otherwise. On the list of top 200 drugs prescribed, we find many combo-drugs such as Advair Diskus, Vytorin, Symbyax, etc. Combo drugs are convenient for patients, and if a company could get the doctor to be aware of their drug, they’ll probably prescribe it because taking one drug vastly improves a patient’s compliance to drug therapy as compared to taking two drugs. Unfortunately, there’s a large hurdle for Cogentus, and that is the third party payers.
The successful combination drugs on the market all contain one common characteristic – at least one of the drugs in the combo is still under patent and buying them in a combination form would save money for a patient/third party payer compared to buying the two drugs separately. If the third party payer does not put Cogentus’ drug onto their formulary, it may be written, but it’s not going to be dispensed. Making a drug attractive to a patient and prescriber is not good enough, Cogentus needs to make a drug attractive to the third party payer. If I was Congentus, I’d try to obtain really good pharmaco-economic models on how the drug would be saving money.
There is yet one last hurdle for Cogentus’ combination drug and that is other generic companies. The generic manufacturer is on a crowded list of companies who function on slim margins. If Cogentus is successful with their venture, what is to prevent a company like Teva from coming along and copying it?
MyOpenCare, a health site that we previously mentioned has announced a compelling competition.
The site has announced the “Create an H-Book and Win Company Shares” contest. In an effort to encourage greater member involvement in the site, the company will offer the winner of the best H-Book 0.5% shares in the company and those finishing second through sixth place will each receive 0.1% of MyOpenCare shares. The H-Book, otherwise known as the Health Book, is is a feature that every User has access too. It allows users to display information about particular disease states and conditions. However, unlike Wikipedia, MyOpenCare gives credit to the author.
The contest is a smart marketing move by MyOpenCare – increase user participation while promoting quality information.
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