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Friday, September 01, 2006
Over-the-Counter Erectile Drugs Come With Health Risks
Dr. Andrew Kramer recently looked over the medical history of one of his patients who had been in the emergency department complaining of chest pains. Kramer was surprised by what he read: The patient had been taking three to four dietary supplements for erectile dysfunction — every day. "I would have never given him Viagra," said Kramer, a urologist at the University of Maryland Medical Center. "He was on the cardiac transplant list." Heart patients are potentially at risk for a heart attack and an early death when they combine erectile dysfunction drugs, such as Viagra, with heart medications that contain nitrates, like nitroglycerine. Both drugs lower blood pressure and together can lower it to deadly levels. Normally doctors won't prescribe Viagra or Levitra to these men, but they can look elsewhere — specifically, the Internet, where herbal supplements of all sorts are available for sale. While some of these supplements may contain harmless ingredients, many are indeed as potent as the real thing. A recent Food and Drug Administration study showed that some of these herbal remedies actually contained the active compound in prescription brands as Viagra, Levitra and Cialis, making them potentially deadly compounds. The FDA issued a health advisory last week against these supplements. "These products are promoted and sold on Web sites as 'dietary supplements' for treating erectile dysfunction and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients." "These companies are promoting medications that we would never give to men with heart disease," said Dr. Dragan Djordjevic, an internist specializing in male sexual health at Rush University Medical Center in Chicago. The FDA specifically targeted the herbal supplements Zimaxx, Libidus, Neophase, Nasutra, Vigor -25, Actra-Rx and 4EVERON, all of which do not list the prescription ingredients on their labels. For this reason, a patient may not realize the risks. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Side Effects May Sideline New Osteoporosis Drugs
Experimental osteoporosis drugs called estrens do not perform as well as researchers had hoped, new animal studies suggest. The drugs did build bone, but they also had adverse effects on reproductive organs and on human breast cancer cells, say researchers from Yale University School of Medicine and a French company called ProStrakan Pharmaceuticals. The researchers "were not able to replicate many of the findings that were found in the original study reported in Science in 2002," said Ushma S. Neill, executive editor of the Journal of Clinical Investigation , which published the findings in its September issue. According to Neill, who also wrote an editorial on the findings, the authors' conclusion is that estren drugs "should not be taken into human trials." The study was partially funded by ProStrakan, a specialty pharmaceutical company that focuses on treatments for bone disease and other areas. Several of the co-authors work or have worked for the company. The results of the current study are at odds with prior research. "Estrens were touted in several [scientific] papers as the answer to osteoporosis in both men and women based on studies in mice," said lead researcher Roland Baron, professor of orthopaedics and cell biology at Yale University. One study, published four years ago, found that the compounds increased bone mass and bone strength in animals and had no adverse effect on reproductive organs. The hope was that the estrens might replace the synthetic estrogens used in hormone replacement therapy (HRT). Millions of American women used long-term HRT to help protect bones and ease menopausal symptoms. But that all changed in 2002, when a major study found the therapy boosted risks for cardiovascular events and breast cancer. In this new study, Baron and colleagues directly compared the new compounds with drugs called SERMs (selective estrogen receptor modulators). SERMs, a newer alternative to estrogens, are thought to display selectivity in the tissues they target, minimizing side effects to reproductive organs. Every drug can have a downside, however. Chronic administration of tamoxifen, one of the most widely used SERMs, has been suggested to be associated with an increased risk for uterine cancer. That makes the search for a safe alternative more imperative, the researchers said. In their study, Baron's team compared the effects in mice of several doses of SERMs vs. two estrens. The results: Estrens prevented bone loss but caused enlargement of reproductive organs in both male and female mice. They also enhanced the proliferation of human breast cancer cells. "It may be that, administered differently, one would find beneficial effects and no bad effects on the reproductive tract," Baron added. But for now, he said, his team has concluded that estrens provide "moderate protection" against bone loss, "but also strong negative effects on the uterus, breast and prostate, suggesting increased risk of cancer if transposed to humans." Osteoporosis is considered a major public health threat for about 44 million Americans, or 55 percent of people age 50 and above, according to the National Osteoporosis Foundation. About 10 million Americans have osteoporosis and are at high risk for disabling fractures. Another 34 million are at risk for getting it because they have low bone mass. Labels: No Prescription, Online Pharmacy, Prescription Drugs
FDA seeks more fees from drugs industry
The U.S. Food and Drug Administration is bargaining with the pharmaceutical industry for an increase in fees, giving the industry a greater role in shaping the priorities of its regulator, The Wall Street Journal said on Friday. The newspaper cited people with knowledge of the matter saying the agency is likely to win some concessions, including new funding for drug safety, partly because of pressure on drug companies from Congress. The Journal said steadily rising payments by drug makers -- $232 million in fiscal 2004 -- now fund more than half the agency's drug-review process, enhancing the importance of the talks. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Thursday, August 31, 2006
Fda Warns of Bogus Canadian Drugs
The U.S. Food and Drug Administration issued a warning Thursday against possible counterfeit drugs being sold on Canadian Internet sites. The FDA said preliminary lab results show counterfeit versions of popular prescription drugs have been intercepted in orders filled by Mediplan Prescription Plus Pharmacy and Mediplan Global Health in Manitoba. The fake drugs included versions of Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex and Propecia. The FDA identified the following sites as sales portals for the two providers: RxNorth.com, Canadiandrugstore.com, Rxbyfax.com, Northcountryrx.com, Canada-pharmacy.com, My-canada-pharmacy.com, NLRX.com, Canampharmacy.com, Canada-Meds-For-Less.net and Canadian-safe.com. In 2005, an FDA sweep at airports in New York, Miami and Los Angeles netted hauls of drugs being promoted as 'Canadian' and found 85 percent actually came from 27 other countries. The agency advised Thursday anyone possessing drugs obtained through the two suspect providers to dispose of them, as they could be unsafe. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Viagra for your heart
It's the little blue pill we all know about. Viagra, the drug famous for helping improve men's sex lives, might actually be able to save lives, too. Johns Hopkins researchers have discovered Viagra may be effective in treating heart disease, too. Billie Marie Evans hopes so. For 49 years of marriage, she took care of the housework. Now that she has congestive heart failure, her husband does most of it. "I depend on him for a lot," she says. "It makes me feel bad in a way." Billie Marie took part in a study at Johns Hopkins University in Baltimore. Doctors followed her and healthy patients to determine the effects of Viagra. "It's an unusual new discovery initially coming out of left field," cardiologist David Kass, M.D., the Abraham and Virginia Weiss Professor of Cardiology at Johns Hopkins, tells Ivanhoe. He and colleagues found the enzyme that Viagra blocks helps reduce the effects of stress on the heart, meaning it makes the heart healthier. Dr. Kass says, "If you push your foot on the accelerator pedal without Viagra, you're suddenly going 100 miles per hour. With Viagra, you're only able to go 35 an hour. So, it's blocking the adrenaline stress on the heart." Tests in mice showed dramatic results. Hearts that were enlarged by stress stayed the normal size when Viagra was used. The first round of tests on healthy patients also showed promise. Viagra reduced stress on their hearts by half. Because Viagra is an approved drug, if the results hold up it could be standard treatment in just a few years. That's good news for the millions like Billie Marie who are anxious for help. "If that would help, yeah I'm willing to try it," she says -- even if it does comes from the unlikely source. In this context, Viagra can be used by men and women. Doctors say it doesn't cause sexual stimulation if you're not in a romantic environment. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Pfizer to close Arnprior plant that makes Viagra, Reactine, Visine
Pfizer Inc. plans to close its Arnprior, Ont., plant that makes Viagra and other drugs because it can produce them more cheaply somewhere else. About 195 employees will be affected when the plant closes at the end of 2008. Plant manager John Carkner said Wednesday that Pfizer plans to close the plant because it is not equipped to manufacture the next generation of drugs "The facility is busy right now," he told CBC News. "Pfizer does have many successful products that we manufacture here, but this is a look to the future. When the patents run out, Arnprior won't fit." Carkner said Pfizer is negotiating to sell the plant to another pharmaceutical company. But if the sale is unsuccessful, the company will start issuing pink slips or transferring employees elsewhere. About 20 positions could be moved to Pfizer's other operations. 'Capable facility' The Arnprior plant is efficient, the company said, but so are several others in the company network. Company officials also said products such as Viagra and Reactine can be made elsewhere at cheaper costs. "The Arnprior site is a capable facility and our colleagues there have made important contributions to our organization over many years," said MacDara Lynch, Pfizer's vice-president of manufacturing for the eastern U.S. and Canada. "Following two major acquisitions by Pfizer since 2000, our manufacturing network has an excess of capacity worldwide, which has required us to undertake a review of our manufacturing operations and make some difficult decisions." Pfizer has closed 31 plants around the world in the past three years, leaving it with 62. The departure of one of Arnprior's most-valued employers concerned Mayor Terry Gibeau, who said the town will take a significant economic hit if it loses close to 200 well-paying jobs and a major part of its tax base. In operation for five decades He said he will try to persuade Pfizer to keep the plant open or sell it to another pharmaceutical manufacturer. The plant produces prescription and consumer health-care products such as Viagra, Reactine, Norvasc and Visine. New York-based Pfizer, the largest pharmaceutical company in the world, has operated a plant in Arnprior for half a century. It has operations in Toronto, Calgary, Kirkland, Que., and the Ontario municipalities of Mississauga and Arnprior, a town 60 kilometres west of Ottawa. It employs more than 2,000 Canadians, including more than 1,300 in pharmaceuticals, approximately 300 in the consumer health-care division and 100 in veterinary products. Labels: No Prescription, Online Pharmacy, Prescription Drugs
FDA warns Americans not to buy from Manitoban Internet pharmacy
American officials say some prescription drugs being ordered over the Internet from a Manitoba pharmacy are not legit. The US Food and Drug Administration in Washington is advising American consumers who bought drugs off 10 websites not to use the medications because they might not be safe. The FDA says prescriptions ordered through the sites are filled by Mediplan Global Health in Minnedosa. Mediplan president Andrew Strempler calls the allegations ``completely false' and says his company regularly tests the drugs it sells and that they are safe and reliable. The FDA said tests showed some of the drugs contained the active ingredients found in genuine versions, but at lower concentrations. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Wednesday, August 30, 2006
FDA Warns Consumers Not to Buy from Various Canadian Websites
The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter. FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed. | DRUG NAME | USE(S) | | LIPITOR | Cholesterol disorders | | CRESTOR | Cholesterol disorders | | ZETIA (US name) / EZETROL (Canadian name) | Cholesterol disorders | | DIOVAN | High blood pressure | | HYZAAR | High blood pressure | | ACTONEL | Osteoporosis in postmenopausal women | | NEXIUM | Gastroesophageal reflux disease (GERD) | | CELEBREX | Arthritis-related pain | | ARIMIDEX | Breast cancer | | PROPECIA | Male-pattern baldness | Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are: As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources. For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian pharmacies." Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be "Canadian" were, in fact, selling drugs of dubious origin, safety and efficacy. Today's announcement is consistent with FDA's earlier message of the dangers posed by such websites and the need for caution on behalf of the public.
Drug counterfeiting is illegal for good reason. Drug counterfeiting defrauds consumers and can expose them to products containing unknown, ineffective, or harmful ingredients. Counterfeit drugs may be toxic or contain doses that are too small to treat a medical condition, or so large that they could endanger the health of the user. Because of the dangers posed by counterfeit drugs, the FDA aggressively investigates all instances of drug counterfeiting.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
Diet Pill Acomplia Seen No Better Than Older Drugs
While Sanofi's new diet drug Acomplia (rimonabant) may help with some cardiometabolic risk factors, lowering triglycerides and slightly increasing good cholesterol, a comprehensive review in the journal Circulation suggests Acomplia is no more effective than older diet pills in reducing bad cholesterol. "Although some features of metabolic syndrome have been shown to improve modestly, no reduction in LDL-C occurs, although this appears to be the case with all centrally acting antiobesity drugs," reports Dr. Kishore M. Gadde, a Duke University obesity researcher. "It is rather disappointing that weight loss achieved primarily with the help of centrally acting antiobesity drugs does not lead to reduction in LDL-C (bad cholesterol) in most studies, and rimonabant is yet another example of this," said Gadde. "In contrast, plant-based and high-fiber diets have been shown to
reduce LDL-C significantly and as much as the statins in some studies. . ." Gadde's also raises detailed questions about Acomplia's psychiatric side effects -- which he recently surfaced in the Journal of the American Medical Association -- while concluding Acomplia is no better for weight loss than "the modest effects observed with currently approved antiobesity drugs." Writing in the Aug. 28 issue of the prestigious journal, Gadde takes a look not just at all published trial data for Acomplia, but at the most recent information available on the three diet drugs currently approved for U.S. sale -- Meridia (sibutramine) and Xenical (orlistat), both approved for long-term obesity treatment, and phentermine. Acomplia, while approved for sale in Europe, has still not been approved for sale in the United States by the Food and Drug Administration for reasons Sanofi has chosen not to divulge. In his review, Gadde acknowledged that in studies with 6,600 overweight and obese patients, rimonabant demonstrated "consistent success" in aiding weight reduction, and "offers a novel mechanism of action, which may make it well suited as an alternative for people who do not respond well to other agents and for combination treatment with other antiobesity agents." But he further elaborated on a point he made in his letter to JAMA: "Although rimonabant appeared to be reasonably well tolerated in general, psychiatric symptoms were the most common adverse effects that led to early withdrawal of patients in . . .trials." In the Circulation review, Gadde noted: - In the RIO-Europe trial, "almost half (42 of 87) of the adverse event–related dropouts in the rimonabant 20 mg group were attributed to psychiatric events, including mood alterations."
Mood was assessed with the Hospital Anxiety and Depression Scale (HADS)58 at baseline and every 3 months. HADS contains 7 items to assess depressive symptoms and 7 items to assess anxiety symptoms, with scores ranging from 0 to 3 for each item. Depressive and anxiety symptoms are separately totaled. Scores of 0 to 7 are considered normal, 8 to 10 represent borderline symptoms, and (equal to or over) 11 are considered significant enough to warrant further assessment of the patient. Questions probing suicidal thoughts are absent in HADS. Thus, HADS is generally not used as the primary outcome measure in clinical trials of depression but is considered an acceptable tool to screen for depression and anxiety in primarily nonpsychiatric patients. In RIO trials, when HADS scores reached 11 during the treatment period, patients were required to be seen by a psychiatrist for further assessment. However, none of the published papers reported the number of subjects who were removed from RIO trials after psychiatric consultations. Whereas the RIO-Europe report stated that there were no significant changes in HADS scores for depression or anxiety, given the above-described methodology of removing patients with mild depressive symptoms, one would wonder if the LOCF (last observation carried forward) imputation method might have underestimated mood changes over time. One would have liked to have known the proportions of patients by treatment with scores reaching (equal to or over) 11 or those with HADS scores that increased by (equal to or over) 25% relative to baseline. - In the RIO-Lipids trial, "psychiatric adverse events in RIO-Lipids accounted for half (26 of 52) of the adverse event–related dropouts in the rimonabant 20-mg group compared with one third (8 of 24) of the withdrawals in the placebo group."
The authors of this article presented mood changes separately as "depression," "major depression," and "depressed mood," when all these could have been combined as "depression"; if so combined, 14 patients in the rimonabant 20-mg group had treatment-emergent depression versus 2 in the placebo group. According to the lead author (personal communication, January 2006), patients with HADS scores (equal to or over) 11 were not excluded from participation in the study, but when the HADS score reached 11 or higher during the study, the patient was referred to a psychiatrist, and the study drug was discontinued for patients needing treatment with antidepressants. It is unclear how patients with HADS scores (equal to or over)11 were allowed to participate in the study when this score was considered high enough to require the patient to be seen by a psychiatrist during the course of the study. - In the RIO-North America trial, "as seen in other RIO trials. . . more patients dropped out owing to psychiatric adverse events with rimonabant 20-mg treatment (6.2% versus 2.3%).
"Although rimonabant appeared to be reasonably well tolerated in general, psychiatric symptoms were the most common adverse effects that led to early
withdrawal of patients in RIO trials," Gadde concluded. "Given the exclusion of patients with a past history of significant depression and current presence of even mild depressive symptoms (as reflected by normal mean HADS scores at baseline) and the removal of patients from the RIO trials after a slight increase in depressive symptoms, it is unclear whether this drug is suitable for obese patients with coexisting depression," he added. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Tuesday, August 29, 2006
PRESCRIPTION DRUG PROGRAM
Details of standard benefit plans for the Medicare prescription drug program, according to the Centers for Medicare and Medicaid Services, a federal agency, and the private Kaiser Family Foundation. Numerous plans exist across the country that vary significantly: • Availability: There were 1,429 stand-alone plans available across the country in 2006, broken into regions. Another 1,314 Medicare managed-care health plans included drug coverage. All coverage is through private insurance. • Participation: Voluntary, except for some low-income seniors who were automatically enrolled if they did not choose a plan. The enrollment deadline for 2006 was May 15, except for seniors who become eligible for Medicare later in the year. An unknown number of seniors who did not sign up by the deadline face a penalty if they want to enroll at a later date. Lawmakers in both political parties have proposed eliminating the penalty, but no legislation has passed. • Monthly premium: Varies widely. The administration says the average in 2006 is $24 and will be about the same for 2007. • Deductible: By federal requirement, capped at $250 in 2006. • Coverage: Individual pays 25 percent of the cost after the deductible is reached, until total drug costs reach $2,250. • Doughnut hole: After total costs reach $2,250, the individual pays the complete cost of prescriptions until out-of-pocket spending on drugs reaches $3,600. • Catastrophic coverage: After out-of-pocket expenses reach $3,600, insurance resumes, and pays 95 percent of costs. • Low-income subsidies: Part of the program. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Antidepressants being used for weight loss
When conventional diets fail, more and more Americans are turning to unconventional treatments in their efforts to lose weight. Drugs for depression and those designed to prevent seizures are among the new weapons in some doctors' arsenals to help overweight patients, even though these drugs have not been approved by the Food and Drug Administration to be used for such purposes. A recent Wall Street Journal article highlighted the "off label" use of drugs for weight loss, from Adderal, commonly prescribed for Attention Deficit Disorder, to Topamax, usually used to treat seizures and migraines. The problem with using these drugs for weight loss, beyond that the drugs haven't been approved for that purpose, is that they often come with nasty side effects. Adderal, for instance, can cause insomnia, aggression and heart problems, while Topamax can cause hyperventilation and fatigue. Another drug sometimes used for weight loss, Wellbutrin, commonly used as an antidepressant, even comes with a black box warning that it can increase suicidal tendencies in children and adolescents. Some doctors question the effectiveness of such drugs as a treatment for overweight people. The drugs seem to work by helping people control their cravings, and weight loss is often a side effect for people taking the drugs for the traditional reasons. A 2002 study found that Wellbutrin helped obese patients lose weight when the drug was combined with diet and exercise. But many people are popping these pills because they don't want to put in the work of dieting and exercise. Some are even bypassing their doctor and buying the drugs on the Internet, a dangerous proposition because of the unknown origin of the drugs and the danger of incorrectly self-medicating (no, we're not giving you links to find out where to buy them). Most insurance plans won't cover this type of treatment because it is off label. People who get the drugs through their doctors can expect to pay $100 to $200 a month depending on the drugs prescribed. Off-label diet pills DrugApproved UseSide Effects AdderallAttention deficit hyperactivity disorder (ADHD)Insomnia, anxiety, cardiac problems ByettaType 2 diabetesNausea, diarrhea, the jitters ProvigilNarcolepsy; sleep apneaHeadaches, nausea, insomnia TopamaxSeizures; migraine headachesFatigue, hyperventilating, difficulty concentrating WellbutrinAdult depressionSeizures, insomnia, juvenile suicide There are two medications approved by the FDA to treat obesity, Meridia and Xenical. They are designed to be used along with a healthier diet and exercise, so they're still not a quick fix like so many people want. Whether these drugs will ever be approved for their off-label uses is unknown. For now, if you want to go this route, it's important to talk to your doctor about it and only take drugs under your doctor's supervision. Don't self-medicate, and keep an eye on the side effects. Losing weight in this way simply isn't worth it if you're causing other damage to your body. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Monday, August 28, 2006
Critics blast FDA for how it handled ADHD drugs alert
The Food and Drug Administration's quiet decision to require heart and psychiatric warnings on attention deficit drugs has sparked new criticism from a top Republican senator and others over the agency's handling of safety issues. The new caution for stimulants such as Ritalin, which came to light last week, follows a wave of recent concerns over antidepressants and painkillers. Meanwhile, some analysts and doctors say the warnings are unlikely to affect the millions of ADHD prescriptions written each month. Senate Finance Committee Chairman Charles Grassley questioned why the FDA and drugmakers did not announce the changes. "Doctors, parents and patients deserved to hear about the changes. They shouldn't have to search high and low for information," Grassley, an Iowa Republican, said Thursday. "It's of great concern if the FDA took a keep-it-quiet approach in order to protect the drug companies," he said. Months after two FDA advisory panels offered conflicting opinions over the warnings, the FDA in May asked most ADHD drugmakers to add warnings. Its decision was made public Monday when the FDA released a letter GlaxoSmithKline, maker of Dexedrine, sent to doctors. Others include Adderall, Focalin and Concerta. "I do wish it had been done in a more public way," agreed Dr. Steven Nissen, who was a member of the FDA panel who pushed for strong boxed warnings on the drugs when it met in February. Labels: No Prescription, Online Pharmacy, Prescription Drugs
Ways to make drugs go down easier
Anyone who has ever tried to give a 5-year-old an antibiotic can appreciate where Edward M. Rudnic is coming from.
As the founder of Advancis Pharmaceutical Corp. in Germantown, one of his goals is to take amoxicillin and convert it to a taste-free powder that could be sprinkled on anything - even ice cream - and tots would be none the wiser. His plans are not quite a reality yet, having run into a snag in clinical testing, but Rudnic hasn't stopped trying. And he is not alone.
Ever since there were drugs, science has looked for ways to improve their delivery to better satisfy doctors and patients. They've turned injections into pills, cut daily dosing amounts and enhanced flavors, hoping it would all add up to happier patients, safer medication and more profit.
But efforts have ramped up recently as advances in technology have made more things possible, and businesses have had to get increasingly creative to find a competitive edge.
It can take a dozen years and $1 billion to create a drug from scratch, which often means a long wait before new companies see any sales.
By taking proven drugs and repackaging them with new delivery systems, entrepreneurs can potentially cut years off the timeline and maybe millions off the price tag.
And along the way, they just might solve a problem that has vexed physicians for decades: People aren't very consistent when it comes to taking their meds.
Some patients are afraid of needles. Others forget to take their pills every four hours. And parents struggle with squirmy children who often hate to take any kind of medicine.
"A better delivery system is a clear way of remedying that, especially if you're talking about a patch or something that [doesn't require] remembering to open up a vial and take X number of pills," said Kenneth I. Kaitin, director of the Tuft's Center for the Study of Drug Development.
With that in mind, companies are developing patches that deliver Alzheimer's treatments and birth control hormones, edible strips that release cough medicine, lollipops that yield a pain reliever for cancer patients and nasal sprays that dispense insulin and anti-obesity drugs.
Diabetes treatments are a hot area, with many companies working on new ways to deliver insulin or check glucose levels. An associate professor at the University of Maryland Biotechnology Institute, for example, has invented a contact lens meant to measure blood sugar.
Elsewhere in Maryland, where biotechnology is considered a key industry, Baltimore's Guilford Pharmaceuticals (which was acquired by a Minnesota company last year) developed an implantable wafer that treats brain cancer.
And at least three Gaithersburg companies are working on unusual ways to deliver drugs: MedImmune Inc. has its inhaled FluMist vaccine, Iomai Corp. is creating vaccine patches, and Panacos Pharmaceuticals Inc. is working on an HIV pill meant to replace a current therapy that has to be injected.
The drug delivery field is among the fastest-growing areas in the pharmaceutical industry. Sales of medications with novel delivery systems are increasing by 15 percent every year, according to market analysts Scrip Reports. By 2009, the drug delivery products and services market is expected to top $67 billion - more than double the $24 billion figure of 2003 - says a study from analysts NanoMarkets.
But a new way of dispensing a drug does not always mean it's better for a patient. Businesses still need to show their replacement versions are as good as or better than the old to get Food and Drug Administration approval.
Norplant was developed as a contraceptive that could be implanted once and protect against pregnancy for five years - unlike birth control pills, which require daily dosing. But it was pulled from the U.S. market in 2000 after women developed serious side effects, including severe headaches and depression.
A similar, but ostensibly safer, birth control implant called Implanon was approved for sale last month.
And not all new versions are as well received as their counterparts. Relatively few people have picked MedImmune's nasal flu vaccine over the traditional shot. The company is working on a new formulation it hopes will sell better.
There are always risks in drug development, but that shouldn't stop the search for improvements, said Stanley C. Erck, president and chief executive of Iomai. His company's goal is no less than changing "the entire way vaccination is practiced." Iomai was founded by a scientist at the Walter Reed Army Institute of Research, where he discovered that you could deliver proteins through the skin and stimulate a powerful response from the immune system.
That led to the 1997 formation of the company and its current portfolio of needle-avoiding vaccine patches: one to combat travelers' diarrhea, another to fight avian flu and a third to prevent seasonal flu. A fourth patch seeks to enhance the traditional flu shot, and perhaps cut the dosage level required to a tenth, possibly helping to eliminate the supply issues that have dogged the vaccine industry.
All of Iomai's patches are still in testing phases and none has yet made it to market, but Erck has high hopes. "If we can show that we can replace the injectable influenza vaccine with a patch, it could be the basis for all vaccines," he said. Aside from convenience, eliminating the needle could cut vaccination costs by also doing away with certain cumbersome storage requirements and the need for paid health care workers to administer the drugs. Erck envisions a day when consumers could obtain vaccine patches at their local drugstores, wear them for a few hours at home, and be good to go. At the Johns Hopkins University, researchers at the newly created Institute of NanoBioTechnology are using tiny particles to make drugs more efficient and multifunctional. "Many of these approaches using nanotechnology are beginning to look like what people conceived several years ago as 'smart pills,'" said the institute's director, Peter C. Searson. In theory, nanoparticles could be added to drugs to help them target specific organs or types of cells. (Nanoparticles and other nano words derive from nanometer, a billionth of a meter.) The goal at UPM Pharmaceuticals Inc. in Dundalk is to make medications that last longer than most. Scientists there are developing liquid blood pressure and pain medications that are easy to swallow and need only be taken once a day, unlike others. "People are willing to pay for that convenience," said UPM Vice Chairman Harold Chappelear. "And the convenience is enormous, it really is." Convenience was a key motivator for Rudnic when he was putting Advancis together in late 1999. Too many antibiotics have to be taken three and four times a day, and he thought he could do better, particularly with amoxicillin, a penicillin that's among the safest and most prescribed drugs available. "There's a lot of companies out there that work on delivery systems," Rudnic said. "I think that the real value is to try to find the true unmet clinical need, where your innovation can quickly be transformed into successful medication." Innovation in antibiotics has been typically focused on the molecule associated with it. Not much had been done with their delivery in years, until Rudnic's team decided it might be possible to deliver the drug in time-released bursts. That means one daily pill could replace multiple doses. There was a lot of trial and error involved in the company's Amoxicillin Pulsys product, with both adult and pediatric versions failing in clinical trials. But earlier this month, Rudnic got the news he'd been waiting for. A retrial of the drug in adults and adolescents showed it was a keeper, and the company plans to seek commercial approval from the FDA within six months. A children's version of the drug, which was to have come in a tasteless "sprinkle" formula that could be added to food, has not fared so well. It stalled after failing in a midstage clinical trial, and Rudnic's team is still trying to figure out how to fix it. They're also trying to come up with ways to adapt Pulsys technology to combat other infections. Said Rudnic: "We're not done yet." Labels: No Prescription, Online Pharmacy, Prescription Drugs
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