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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)
Eighty-two percent of respondents reported turning to medical professionals for health information, while 51% said they consult their friends, family or significant others.
The survey also found that 85% of women who use the Internet have researched women’s health issues online, while nearly two out of three women who use the Internet have researched birth control options online.
Results are based on a survey of 921 women ages 18 to 44.
To the numerous list of health innovations the Wii can do, we add in improving surgery performance by 50%.
The BBC reports that researchers at the Banner Good Samaritan Medical Center studied eight surgeon trainees who trained for an hour on a Wii before performing 50% better on a virtual surgery simulator. Their scores excelled in the areas of tool control and overall performance as compared to those who did not.
The game in question is called Marble Mania, which involves moving a marble through a 3D maze.
To be fair, the researchers should pit these “Wii-surgeons” against those who meditate, visualize, pray, or perform hand exercise before surgery.
In any case, the researchers claim that the fine movement of a ball through a maze are complementary to skills which would help a surgeon in surgery. They also suggested that perhaps spending $250 for a surgery prep device is a great alternative for poorer countries to train their surgeons as compared to buying an expensive surgery virtual simulator.
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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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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.”
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?
This is from the pile of cool products you may not know existed. The GlucoWatch is made by Cygnus, Inc of Redwood City, CA and was approved by the FDA on March 22, 2001. In March of this year, Animas Corp of West Chester, PA bought out Cygnus for $10 million. As of July 31, 2007, Animas will no longer be marketing the GlucoWatch.
What is it?
The GlucoWatch Biographer is a glucose monitoring device that a patient wears like a wrist watch. Glucose measurements are taken non-invasively through the skin every 20 minutes for up to 12 hours at a time. The GlucoWatch measurements are not intended to replace finger-stick glucose measurements, but instead should be used to detect trends and patterns in glucose levels. It is only approved for use in adults age 18 and over.
How does it work?
After a 3-hour warm-up period, the patient calibrates (sets) the GlucoWatch Biographer using a finger-stick measurement. After calibration, the Biographer will begin monitoring glucose values. A low level electric current pulls fluid through the skin into gel discs in the Biographer. Electrodes in the Biographer measure glucose in the collected fluid for up to 12 hours at a time. The GlucoWatch Biographer also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low levels and above pre-set high levels.
Why is it used?
The GlucoWatch Biographer is not intended to replace fingerstick measurements but used to see the rise and falls of glucose throughout the day that intermittent fingerstick measurements cannot tell. This additional glucose information may help people with diabetes and their healthcare practitioners better manage their disease by providing more information on glucose trends.
So why was this product so successful?
There were many reason why the GlucoWatch didn’t succeed, but in my personal opinion as a healthcare practitioner, the primary reason is because it wasn’t accurate. The reason that the GlucoWatch wasn’t accurate is because the glucose that they measure was plasma glucose that had traveled through all the tissue of the skin, whereas fingerstick measurements take the glucose out of whole blood (a droplet of blood). A practioneer and a patient needs to count on the accuracy of any test measurements, the GlucoWatch just did not provide that stability. It’s a great idea, and one that is critically needed, but the execution needed some work.
Hologic, Inc. announced that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended the pre-market application for Adiana Permanent Contraception for female sterilization as approvable in a panel vote of 10 to 3.
The FDA is not required to accept the panel’s decision, but traditionally follows their recommendations. The panel recommended approval of the device contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations.
Bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is the most common form of contraception used throughout the world. The surgery is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.
In contrast, Adiana is a minimally-invasive, non-incisional alternative. This procedure uses hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are typically able to return to work or resume their everyday activities within a day.
Adiana is a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient’s fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers an implantable, soft polymer, called a “matrix,” which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. Healthy tissue will grow into the matrix, creating a complete blockage of each tube.
Menlo Park-based biotech company, Fundamental Applied Biology (FAB) announced that it received $21 million in second round funding with Daniel S. Gold as the new CEO.
FAB is built on technology developed by Stanford professor, James R. Swartz. Dr. Swartz’s protein synthesis technology is a departure from current technique where protein replication used for industrial means (such as medicine) is made by an actual cell; a process that is slow and plagued with inefficiencies. His technology allows proteins to be made outside the cell, improving production time, yield and purity.
Investors can expect biotech companies that utilize such systems to produce medication with lower production cost and faster turn around time to better respond to market demands.
Pfizer has not been doing very well this year [Source: Can we Count our Pfizer?] With several of its products going generic soon and with the recent pull of Exubera, its inhalation insulin, one would expect Pfizer to be slowing down. However, this giant has no plans on treading behind. Pfizer will be the “Come-Back Kid” for the year 2008.
In its current reorganization process, Pfizer has announced a launch of a new biotechnology division to be based in San Francisco, CA. This new division will be headed by Exelixis founder, Corey Goodman, Ph.D. Dr. Goodman was also recently the founder and CEO of Renovis, a now publicly traded biopharmaceutical company. Exelixis is a publicly traded pharmaceutical company.
Jeffrey Kindler, Pfizer CEO, comments that,
“with this strategy, we are leveraging Pfizer’s excellence in drug discovery and development by complementing it with a distinct, California-based enterprise led by world-class scientists charged with discovering and bringing in new compounds.”
In addition to focusing on attracting new technologies in drug development, the biotechnology division will also serve as an incubator for startup ventures.
According to a company statement, the group “will work in a highly collaborative manner both with Pfizer Global R&D and with the academic, biotechnology and venture communities, not only to focus on delivering new compounds for Pfizer but also on incubating start-ups with new innovative technologies.”
It looks like Pfizer has spotted the light at the end of the tunnel and will be positioning themselves in the perfect place here at the start-up hub of the universe, Silicon Valley.
A phenomenon that most diabetics often encounter is hypoglycemia or an abnormally low level of blood sugar. Because the brain runs primarily on glucose, hypoglycemia may severely harm the patient, putting them into a coma or worst. The most common causes of hypoglycemia are certain classes of anti-diabetic medications or insulinomas. Whatever the cause, it is recommended that diabetics carry glucose tablets in case of a hypoglycemic event.
Novo-Nordisk has just released a kit called the GlucaGen HypoKit (see picture below) that allows a patient to inject glucagon directly into their system.
Taking a look at this needle and syringe system, it looks intimidating to use. The directions released from Novo Nordisk are as follows:
Just in Case - Simple Steps for Use
- Insert the needle through the stopper and inject all the liquid into the vial
Insert the needle through the rubber stopper on the glucagon vial. Inject all the liquid in the syringe into the vial. The rubber stopper can be stiff, but the needle is strong enough to puncture it.
- Gently shake the vial
Leave the syringe in place and gently shake the vial until the powder is completely dissolved.
- Withdraw all of the liquid into the syringe
While the needle is still inside the vial, turn the vial upside down and while keeping the needle in the liquid, slowly withdraw all the liquid into the syringe.
- Inject the solution into loose tissue
Insert the needle into loose tissue under the injection site and inject the glucagon solution.
- After GlucaGen HypoKit Treatment, Give Extra Carbohydrates
As soon as the person awakens and is able to swallow, he or she should be given extra carbohydrates. This is especially important in children and adolescents. These carbohydrates can include a fast-acting source of sugar — such as a regular soda pop or fruit juice — and a long-acting sugar — such as crackers and cheese or a meat sandwich.* It is recommended that the person with severe hypoglycemia be examined by a doctor.
My question is, why didn’t Novo Nordisk make it easy to use like the Epi-Pen?
The directions for the EpiPen is as follows: 1) pop the safety cap 2) jab the pen into your thigh 3) call 911.
In an emergency situation, an individual does not have time to fidget with a needle and syringe (the effects of hypoglycemia is light-headedness, shakiness, confusion).
Novo Nordisk, turn the GlucaGen into the GlucaPen, and then perhaps you’ll save some lives.
Pfizer just pulled their Exubera (inhaled insulin) from market. A horrible way to end a horrible year for them.
Pfizer’s decision to pull Exubera was purely a financial one. Thus far this year, the company has sold less than $15 million worth of Exubera. This accounts for less than 0.3% of the insulin market. A blockbuster drug is defined as one that has sales over $1 billion annually. Exubera is far from that mark and the pull from market will result in a loss of $2.8 billion for Pfizer.
It may be best that Exubera was pulled. Exubera uses insulin supplied in blister packs. To release the insulin, each individual blister pack is put inside the inhaler and then the patient would depress a button to release the insulin. This is where the confusion begins. If a patient uses three 1mg blister packs, it does not equate to using one 3mg blister pack. Due to the pharmacodynamic properties of the medication, 1+1+1 does not equal 3 in Exubera’s case. Pfizer’s new math creates confusion that may have caused some healthcare professionals to be hesitant in prescribing it.
Exubera’s woes are not the only blow to Pfizer this year. Zoloft (anti-depressant) became available as a generic in June 2006 and Norvasc (anti-hypertensive) became available as a generic in March 2007. Take a look at Pfizer’s third-quarter earnings compared to other Pharma companies:
Pfizer
3Q Revenues : $12.0 billion (-2%)
3Q Earnings : $761 million (-77%)
YTD Earnings : $5.3 billion (-45%)
Bristol-Myers Squibb
3Q Revenues : +22%
3Q Earnings : +154%
YTD Earnings : +35%
Merck
3Q Revenues : +12%
3Q Earnings : +62%
YTD Earnings : +24%
GSK
3Q Revenues : +5%
3Q Earnings : +2%
YTD Earnings : +8%
Genentech
3Q Revenues : +22%
3Q Earnings : +33%
YTD Earnings : +41%
Novartis
3Q Revenues : +9%
3Q Earnings : +267%
YTD Earnings : +100%
What Pharma slump? It seems that Pfizer is amongst the only one of their friends who are loosing money this year. Is this the beginning of the end for this noble giant awaiting to be a meal for one of its comrades? No. Pfizer earned the most money last year and despite their woes, Pfizer is still the number three player behind Novartis and J&J. Pfizer has A LOT of cash after it sold a few of its subsidiaries. It is evolving and restructuring.
Their future focus? Biopharmaceuticals and the Internet…(Health 2.0?) [Pfizer: Foratv, Pfizer: Sermo]
On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 or FDAAA. Along with continuing FDA user fees, the act contained numerous other issues and is considered the most significant revision to the Federal Food, Drug and Cosmetic Act (FDCA) in decades. We’ll cover the overview of it here.
- Drug User Fees
- Pediatric Research
- Clinical Trial Databank
- Post-marketing Safety
Drug User Fees
Currently the FDA charges companies to submit their application for New Drug Application (NDA), this was to expire September 30 of this year. This expiration prompted the quick passage of FDAAA – Title I, the Prescription Drug User Fee Amendment (PDUFA). This amendment authorizes the FDA to continue to collect these fees until 2012, increasing total fees by $90 million a year to $393 million annually. Additionally, it allows the FDA to collect an additional $225 million to enhance drug safety. One of these fees will come from direct-to-consumer television advertisements. The fee is for reviewing such ads.
Pediatric Research
Title IV – Pediatric Research Equity Act (PREA). This act requires manufacturers of new ingredients, indications, dosage forms, regimens and route of administrations to submit a pediatric assessment. Manufacturers may request a waiver if pediatric formulations are not possible. PREA is active through 2012.
Clinical Trial Databank
Title V – Requires that all drug/device/biologics clinical trials (except Phase I) be registered in an FDA controlled database. This is significant to what was previously required of “serious or life-threatening” diseases. The information from the database will include demographics, primary and secondary outcomes. The intent of this section is to enhance patient access to and understanding of clinical trial results. A penalty of $10,000 per day will be accessed for those companies who do not follow these guidelines.
Post-marketing Safety
Title IX – strengthens the FDA’s powers of asking companies for post-marketing studies on their drugs. One of the biggest problems that I have with the previous FDA system is the lack of post-marketing data from drugs. In the current structure, the FDA uses primarily Phase 3 clinical trials (large pre-marketing clinical trials conducted on thousands of participants) to decide passage of a New Drug Application (NDA) and rarely asked for Phase 4 clinical trials (post-marketing) data.
While at the FDA, I brought up the issue of Phase 4 trials on numerous occasions but quickly became aware that changes could only be done from the top (Congress). Title IX still does not go far enough in regards to post-marketing data. In my perspective all manufacturers need to conduct Phase 4 trials. While Phase 3 trials are large (thousands), Phase 4 trials can contain millions of participants and a much broader patient demographic.
With the recent string of debacles at the FDA, the public does not understand that the FDA is drastically under-funded to look after the prescription drug/device/biologic market. I am really glad that FDAAA allows the bureau to obtain more money and consequently more man power to regulate this system.
The is an update to an earlier article, read it here.
23andMe officially launched today, November 19, 2007 in Mountain View, CA. Although their business plans were not completely revealed, their pricing structure was. 23andMe will charge $999 for the use of their genomic analysis tools indefinitely. Friends and family can also sign up for a 15% discount (or “at cost” for their cost). This suggests that their margin is not very substantial.
In signing up, the user signs an agreement that allows 23andMe to use their genomes for “research” purposes and reads as follows:
23andMe Sponsored Research: We may analyze your genetic and other voluntarily contributed personal information as part of our scientific research with the purpose of advancing the field of genetics; your account information will never be associated with this research. We may also analyze your genetic and other contributed personal information for the purpose of reviewing and improving our services and creating new features and services. We may ask you questions and you may choose to give us information about yourself through surveys or other features on our website. Contributed personal information might include age, sex, geographic ancestry and diseases or conditions you have, or have experienced. It is entirely within your discretion to provide information or answer survey questions.
Collaborative Research: 23andMe may enter into partnerships with other organizations—non-profit and/or commercial—that conduct scientific research. Prior to embarking on any such projects, 23andMe will establish a research advisory committee to guide such collaborations. 23andMe may grant researchers associated with partner organizations access to our database of genetic and other contributed personal information after such organizations agree to maintain confidentiality consistent with our privacy policy. External researchers will have access to your genetic and other contributed personal information but they will not have access to your account information (e.g. contact and payment information).
During today’s webcast, founders, Linda Avery and Anne Wojcicki emphasized the academic pursuit of the genomic information. Others have suggested that 23andMe will sell their customer’s information to pharmaceutical and biotech companies as the main source of their income and which is the primary reason why they have not revealed their business plan to the general public.
The question, as suggested before: who is responsible for the use of one’s genetic material?
While 23andMe intends to turn their clients into a social networking group, they do face competition from similar service providers such as Navigenics and DeCode Genetics’ DecodeMe.
November 14, 2007, the FDA announces that GlaxoSmithKline’s (GSK) Avandia (rosiglitazone) is to bear a second blockbuster killer - a black box warning label. Like all black box warnings, it states that doctors should be careful about prescribing the drug and to especially weigh out the pros and cons. Specifically in Avandia’s case, the drug exacerbate conditions of heart failure patients (which was the first one that it received in August of this year) and then now a second label is to be added indicating that the drug could cause heart attacks heart related risks (this correction was also made by the FDA). This drug has been known for since its introduction to worsen heart failure and presumably prescribers were not writing it for their patients who had heart failure, but the news for heart related risks and ambiguously, for heart attacks, is new.
Whatever the case maybe, Avandia now has a second black box warning. According to the TNS Healthcare’s Diabetes Dynamics USA™, for the time period from July through September 2007, 70% of all prescribing instances of Avandia was through discontinuation. Avandia and their drug groups (GSK has combination drugs which contain Avandia) is a $2.3 billion a year drug (according to GSK). What typically happens to drug which gets a black box warning is that their prescription rates drop down to 10% of what it was before (Pfizer’s Celebrex did). For GSK, this means a loss of $2.1 billion in gross revenues. Prescribers shy away from writing black box labeled drugs because it increases their likelihood of being sued for malpractice as lawyers tend to pick at details that are out of normal practice. Avandia, now has two black box warnings.
Yet another damnation to Avandia emerged when the US Department of Veterans Affairs (VA) revealed last month that it is removing Avandia from its list of approved drugs, and will severely limit its use. The VA will recommend that patients currently taking Avandia may continue, but strongly urge doctors to discus the associated risk with their patients. VA sales of Avandia represent about 8 per cent of total US Avandia sales, which have fallen an estimated sixty per cent since May.
Avandia is an anti-diabetic drug which was approved by the FDA in May of 1999 for single therapy or in combination with other anti-diabetic medications such as metformin (Glucophage). Avandia belongs to a group of drugs called thiazolidinediones or “insulin sensitizers”, in the medical community, it is recognized that thiazolidinediones is not a very good group to be used as monotherapy for diabetes but is great in adjunct therapy to other medication as their results are synergistic. The only other drug in this group is Actos (pioglitazone) of Takeda Pharmaceuticals. Takeda is the largest pharmaceutical company in Japan.
Schering-Plough has been planning this merger for over the last year. Finally, today the FTC gave the company anti-trust clearance for acquiring Dutch drugmaker Organon BioSciences from Akzo Nobel. The European Commission gave their approval back in Oct. 11.
Schering-Plough will be acquiring Organon BioSciences for it’s four divisions:
- Organon – focusing on human pharmaceutical
- Intervet – the animal health division
- Nobilon – human vaccine development unit
- Diosynth – third-party manufacturing unit
Finalization of the company parts are expected by the end of the year. The only question now is: what’s the new company going to be called? Schering-Plough-Organon? SPO? The Schering Group? SOP? I just hope it’s not the last one.
November 14, 2007. Rockville, MD. The FDA passes Roches’s Mircera, long-acting erythropoiesis-stimulating agent for the treatment of anemia associated with chronic renal failure in adults.
But this is just the first of hurdles for Roche as they are in a legal battle with Amgen over the product. Amgen claims that Mircera infringes upon six US patents it has for their anemia product: Epogen (epoetin alfa).
The case is in federal court at the time of publishing and hearing is not expected until early 2009.
Epoetin alfa (r-HuEPO) is a recombinant form of the renal hormone erythropoietin (EPO) and belongs to a class of drugs known as erythropoiesis-stimulating agents (ESAs). Erythropoietin (EPO) is a protein that regulates the production of red blood. Epoetin alfa has the same activity as EPO. In adults, almost 90% of EPO is produced in the kidney with the remainder produced by the liver. People with kidney damage loose the ability to make new EPO and create new red blood cells and cause anemia, and hence these products being targeted in those patients.
I bring a challenge to glucometer makers, make a meter that is so simple to use that a patient does not need instructions prior to using it. (Glucometer is a trademarked brand of the Bayer Company but is also used generically to refer to all types of blood glucose meters).
The problem.
Your current meter comes in 4 parts. The meters are designed to be smaller but after you add all four parts up and put it into the carrying case, it’s not so small after all. The parts are: The meter, the test strips, the lancet device and the needles (or lancet). Why can’t you make all these things into one device? Do you not realize how hard it is to explain to a 75 year old patient how to take his blood sugar? He has to first clean his hands. Load the needle into the lancet device. Poke himself with the needle. Put the test strip into the meter. Align his fingers into the strip and draw up enough blood.
PEOPLE DON’T TEST REGULARLY BECAUSE IT’S TOO DIFFICULT TO!
I don’t understand the marketing reasoning behind such difficult testing techniques. If you only design a simpler device, you’ll have people testing them three to six times daily and you’ll get more profit!
There have been some breakthroughs on the technology of blood glucose testing. Some of which includes infra-red readings and plasma readings, and both of which are non-invasive. The later refers to a device which the patient would wear like a watch. The device draws out the plasma (the watery part of the blood) from the blood, through the skin and into the device. A laser beam is then passed through the plasma to determine the glucose content. Unfortunately, such technologies are not quite perfected yet. Historically, testing techniques that do not use whole blood (including the red blood cells part) is not an accurate measure of one’s blood glucose measure. In the plasma example, what is making the test less accurate is that as the plasma passes through your tissue and skin, it picks up more glucose/drops some off and the reading is not adequate.
To reiterate my challenge.
Make a simple device that a patient can put to their finger, press a button, and the device does the rest of the work to get the reading. This would include pricking the skin and retrieving the blood. And please….do away with the calibration business. Why does a patient need to punch in the numbers on the bottle when it could be printed on the test strip and read by the meter.
Thank for your dedication into making this device. I promise to tell all my patients (my dad included) to use it and all my contacts to recommend it. [if it's good that is]
Well, not exactly. In one of my wildest fantasy, we live in a world where humans can generate anatomical parts that stop working or have loss in accident or injuries. Norriton, PA, Tengion brings us one step closer to this fantasy. Tengion is a biotech firm focused in tissue regeneration in diseased or damaged organs. They’ve recently raised $33 million in third round funding with investors such as Deerfield Partners, Bain Capital, Johnson & Johnson Development, HealthCap, Quaker Bio Ventures, Oak Investment Partners, L Capital Partners, Horizon Technology Finance and Oxford Finance.
Currently, they’re working on regrowing bladder tissue to treat patients with spinal bifida or spinal-cord injuries. This technique was designed by Dr. Atala of Wake Forest University’s Institute for Regenerative Medicine (IRM). You can read more about Dr. Atala’s technique here. The above picture shows Dr. Atala and what the bladder tissue that he grows look like.
As many of you still remember, we’re able to grow “simple” tissue which doesn’t have complex biological functions as in the much publicized ear on a nude mouse. So what Tengion is attempting to do is to grow complex tissue of organs which are involved in complex biological functions such as the bladder.
Biologically speaking, we know that lizards and some other animals are able to regrow limbs after they are loss. If they are able to do it, theoretically, we should be able to do it as well (I know that does sound like something out of a Spiderman comic), but I really do believe that to be true someday. Cell growth are stimulated by the proper hormones and stimulant being released. Some examples have been seen in the regrowth nervous tissues in which cells know where they are suppose to be and they migrate there. It is not too far to see that if could potentially grow another arm if it is loss.
Read more about Tengion here.
Let me start by saying that there is a severe eye condition called wet age-related macular degeneration (wet AMD) which the affected elderly patient has blood vessels that grow and break into the layers of the eye causing blindness (the . A very good treatment, just approved last year by the FDA is called Lucentis (ranibizumab, recombinant humanized monoclonal antibody fragment). Lucentis costs about $2,000 a month for injections. There is another similarly structured anti-cancer drug called Avastin (bevacizumab, humanized monoclonal antibody), which doctors and researchers have found out could be used to treat wet macular degeneration for only about only about $40 a month. Prescribing a drug for other uses that was not indicated by the FDA is nothing new in the medical world and is often supported by drug companies so that their drugs could be used more often without them filling for new indication NDA with the FDA. Now here comes the good part.
[the image on the left is normal vision, the image on the right is what someone sees if they have age-related macular degeneration (AMD)]
This just means the company that owns Lucentis is loosing a lot of money to the one that owns Avastin. It turns out that South San Francisco, CA based Genentech owns both drugs. Cowen & Co. analyst, Eric Schmidt calculated that Genentech is loosing $800 to $900 million dollars a year on Lucentis because of Avastin use in this way. Genentech’s solution? Stop the supply of Avastin to compounding pharmacies, indicating that the FDA warranted sterility causes for concern in Avastin being used for ocular purposes. This fact is not yet proven and is probably false because if an injectable is sterile enough to be injected, then it’s good enough to be used in the eye. While this is not going to stop the use of Avastin for wet macular degeneration, it does shine a light on the priorities of Genentech.
As the fall of Big Pharma from the graces of the public, biogenetic companies seem to naturally fill the void of trusted companies, and this recent action by Genentech proves that they’re just people a company after all.
On the face of it, one might be very quick to judge the company, and yes they’re trying to put a positive spin on this (fact is, there isn’t a positive position for patients and third party providers in all this, but Genentech investors should be happy). Let us not forget that a company is out there to make money and in the words of all those Godfather movies, “it’s not personal, it’s just business”. It’s a great business move, but poor strategy and execution of their plans. Sure, they’re get a lot of bad press for it, but nothing will change and people will forget.
You can read more about the story here, here, here, here, here and here.
Dendreon Corporation out of Seattle, WA, is working on a Prostate Cancer Vaccine. Currently, the FDA has asked for more information in regards to its efficacy. There were some speculations that the FDA might pass it a few months back but often people mistake silent discussion to chance for passing. After being at the FDA for a while, I can tell you that the more controversial or the more a drug is in media coverage the harder it is to pass or the more scrutinized a drug will be at the FDA. Therefore, it’s a double blade sword, you advertise your drug before it comes out to get people talking about it so when it’s pass you’re off and running, but at the same time, the FDA will give you a harder time. I wouldn’t recommend it to anyone. I could tell you stories about what happened with the “female viagra”, but I am not going to, because that’s not right!
Dendrion’s technique works with dendritic cells (no relations to nerve cells with their dendrites) of the immune system. This cell type takes in foreign materials (antigens) and presents it to the body (other immune cells called T-cells and B-cells) which will then mount an attack towards the foreign object. Specifically, Dendreon’s technique work with prostate cancer antigens. Keep in mind that a cancer cell is really our cell, so finding something foreign on our own cells is quite impossible (almost). Yes, cancer cells are our own cells, but some cancer cells will express proteins on their surface that are exclusively their own, meaning none of the other cells in our body expresses it, although we could.
Dendreon plans on taking a patient’s dendritic cells out and modify it so it presents the prostate cancer antigen, therefore the our own immune system will recognize those same antigen when when they appear and kill them, or so is the theory goes. Dendreon does not plan on making this procedure a treatment (on people already inflicted with the disease) but as a vaccine (healthy people who may get sick). For this reason, it’s probably giving them a harder time at the FDA as well. Safety for this vaccine needs to be really good to warrant giving it to a healthy individual. Dendreon’s Provenge is being developed as a treatment for men with advanced, hormone refractory prostate cancer, not for healthy men (as corrected by Dr. Kevin Slawin). With Dendreon’s currently patient database, they are about a year away from showing more efficacy data to the FDA.
Also note that prostate cancer is one of those cancers which are curable if detected early enough and treated properly, but it is also a very slow acting cancer, so it also hard to detect that something is wrong. If you’re male and over 35, get a regular digital rectal exam (DRE), through this exam, the doctor could be able to tell if you have an enlarged prostate.
Thanks to the input by Dr. Kevin Slawin of the Vanguard Urologic Institue. Dr. Slawin is the Director of Vanguard Urologic Institute and the Texas Prostate Center in Houston, TX, he is also the recipient of the F. Brantley Scott, M.D., Jr. Award for Innovation and Creativity in Urology.
Congratulations Vice President, Mr. President, Al Gore for winning the Nobel Peace Prize for his work on getting the world to realize the crisis of global warming. You can read more about it here.
I wondering if he’ll get a congratulatory call from President Bush?
Oriel Therapeutics is a lab out of Research Triangle Park, NC. They just went through third round funding for an undisclosed amount. They’re in works on a new inhaler technology that promises to be more efficacious than the current metered-dose-inhalers (MDI). [Reference: VentureBeat]
Inhalation drug is one of the best and most invasive ways of getting drugs into the body, that is, if we’re able to successfully get it to the site of absorption there at any accurate amount of the time.
Current MDI technology has an Achilles’ foot in that it does not deliver enough drug deep down enough to reach the alveoli. The alveoli is where all the air transfer and drug absorption takes place. The majority of the drug typically get caught in the bronchioles. There has been other advances where others have used another solution before the inhaler to coat the lining of the bronchioles so drugs don’t get caught there providing a free passage for the drug, but this technology is not perfect either. I am curious at what they’re doing and hope they they will be able to come up with something more successful.
My prediction is that inhalation drugs is the way of the future. Being with Exubera, the fast acting inhaled insulin from Pfizer, we’ll start to see more drugs being delivered this way, with a promise for at least two more insulins being delivered this way within the next two years.
Sorry for the pun. Bioheart, Inc is a biotech startup out of Sunrise, FL that specializes recovering dead heart tissue from adult stem cells. Bioheart now plans to offer 4.2 million shares at a price of $6 to $8 each (they previously had plans on a offer of $14 to $16 each). At the current price, the company would plan on making a much as $38.8 million, giving the company a value of $140 million. This is a bit slim for current standards.
Bioheart’s procedure is called MyoCell, a technique which harvest myoblasts (adult muscle stem cells) from a patient, and after a 21-day incubation period would inject them into dead myocardium (heart muscle tissue) causes by an MI/heart attack. A similar procedure was done on a small group of diabetic patients who received stem cells injected into their pancreas while made new insulin-producing beta-cells and helped with their disease (NOTE: Diabetes is more than a disease of insulin production, it also concerns the body’s non-response to insulin). On the face of it, the procedure seems like a great idea, but to date they have yet prove the procedure successful.
Repairing myocardium is not as simple as putting in new tissue. The heart is specifically designed to a certain width. By adding in new tissue one needs to ask a few crucial questions: what is to be done with the old heart tissue? will the heart just get thicker? Where will the new tissue reside? I am the first one to endorse Bioheart if their procedure is shown successful. I lost a grandmother (the only grandparent that I ever knew) to said dead myocardium. After bypass surgery, she was fine, but her old weak that had the dead myocardium could not stand the extra pressure created by the increased pressure created in the heart. Believe me, this technology is very personal to me and anyone who has a love one who have had an MI.
Bioheart to date has raided $51 million in fuding from Dan Marino Investments (the answer to your question is yes), Ascent/Meredith Asset Management, Getz Medical, Guidant, Tyco Ventures, Getz Bros., St. Jude Medical, Advent-Morro-Guayacan Private Equity Fund, Astri Group, Minnesota Bio-Med Partners, New World Angels, Presidential Capital Partners and other individuals. I can assure you that there are at least some people in that group put money into Bioheart not because they hope to make money, but rather they hope that this technology would work purely on humanitarian/personal resolve.
I’ve always wondered about the legitimacy of About.com. Like all search junkies, I’ve stumbled upon this site several times and typically because it’s just for some computer related information so I didn’t give it much thought. But I have always wondered about whether I can trust is site with so much advertisement on the sides. A few is okay, but it’s just a bit too cluttered. It makes me think that these people care about their advertisers more than their information.
This morning I was doing some information gathering about SSRI and SAMe, something as a doctor of pharmacy, we’re trained to know. Then I stumbled upon this article about SAMe on About.com. The woman who wrote it is an ND or naturopathic doctor. I know this doesn’t affect other people with the same degree, but she claims in the article that you CAN use SAMe with an SSRI! Yes, the information just blew my mind.
SAMe is an herbal drug that’s used as an antidepressant because it increases the levels of serotonin in the brain. SSRI, or selective serotonin receptor inhibitor, also increase the levels of serotonin in the brain. On the face of it, if increasing serotonin in the brain helps with the depression, then doing it a lot would be great. Not so, too much serotonin causes what’s called serotonin syndrome. The condition requires immediate medical attention, with symptoms including anxiety, restlessness, confusion, weakness, tremor, muscle twitching or spasm, high fever, profuse sweating, and rapid heartbeat. A person can definitely die from this syndrome if immediate medical attention is not sought.
What really bothers me about this article from About.com is that they don’t have any place for me to give feedback. I don’t mind that information from sites such as these have some wrong information if they offer a place where readers can comment on what is written and offer changes to the article. And lastly, what is unforgivable is that this error in information could kill somebody.
People really should check over their health information before they post it online…*sigh*