Johnson & Johnson recalls 57 lots of pediatric Tylenol products.

Johnson & Johnson recalls 57 lots of pediatric Tylenol products.

The AP (9/25) reports that on Sept. 24, "Johnson & Johnson's McNeil unit" announced that "it is voluntarily recalling 57 lots of infants' and children's liquid Tylenol [acetaminophen] products because of possible bacterial contamination." All of the "products being recalled were made between April and June" 2008 "and include nearly two dozen varieties, including Children's Tylenol Suspension 4 oz. Grape, Infants' Tylenol Grape Suspension Drops 1/4 oz., and Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum."

The Dow Jones Newswire (9/25, Favole, subscription required) reports that, according to Johnson & Johnson, the company agreed to recall the medicines after consulting with the Food and Drug Administration, even though the possibility of medical harm is slim.

The Los Angeles Times (9/24, Dennis) "Booster Shots" blog reported that the recall was implemented "because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements. Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected." Even though "the portion of raw material in which the bacteria was found was...not used in the production of any finished product," the manufacturer decided to "recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria."

WebMD (9/24, Hitti) reported that in a recall letter dated Sept. 18, McNeil Consumer Healthcare stated, "Adverse health consequences of B. cepacia infections could be potentially severe, especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis, or compromised immune systems." MedPage Today (9/24, Peck) and Florida's Palm Beach Post(9/24, Isger) also covered the story.

Consumption of alcohol may interfere with controlled-release drugs, study suggests.

MedPage Today (9/24, Fiore) reported that, according to a study published online in the journal Molecular Pharmaceutics, "consumption of alcohol may interfere with controlled-release drugs, potentially sending an excess of active ingredient into the bloodstream." After conducting a meta-analysis, researchers found that "ethanol tended to impair the release mechanism, sending the drug more quickly into the small intestine" -- a "particularly worrisome" finding "in the case of controlled-release opioids."

Experimental AIDS vaccine shows unexpected efficacy in trial.

Experimental AIDS vaccine shows unexpected efficacy in trial.

The Washington Post (9/24, Brown) reports, "An experiment in Thailand involving 16,000 men and women has demonstrated for the first time a small but measurable protective effect of an AIDS vaccine." The Post calls the results "barely significant on statistical grounds, perplexing for scientific reasons and unanticipated by most researchers. Nevertheless, the first positive results for an AIDS vaccine after two decades of experimentation was being called a milestone."

"I don't want to use a word like 'breakthrough,' but I don't think there's any doubt that this is a very important result," Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), told the New York Times (9/24, McNeil). The vaccine, known as RV 144, "protected too few people to be declared an unqualified success. And the researchers do not know why it worked."

The AP (9/24, Marchione, Casey) reports, that "the vaccine cut the risk of becoming infected with HIV by more than 31 percent." It is a combination of Sanofi Pasteur's ALVAC "and AIDSVAX, originally developed by VaxGen Inc." The vaccine was tested "in a 'prime-boost' approach, where the first one primes the immune system to attack HIV and the second one strengthens the response."

The US Army funded the study along with the NIAID and the NIH, Bloomberg News (9/24, Bennett) adds. For the study, "researchers enrolled volunteers in Thailand's Chon Buri and Rayong provinces, which have the nation's highest rates of HIV." Volunteers "were given four doses of the ALVAC vaccine and two of the AIDSVAX shot over six months, then monitored for three years. They were also given advice on safe sex."

Researcher Dr. Jerome Kim, a US Army colonel at the Walter Reed Army Institute of Research, said, "We had 74 infections in the placebo group and 51 in the vaccine group," Reuters (9/24, Fox) reports. Dr. Fauci admitted that he "did not think there was a very high chance that this would give any degree of efficacy." Dr. Fauci added that "nonetheless, we went ahead with the trial and it was controversial to go ahead with it."

Shortage of Tamiflu seen nationwide.

FDA confirms three new cases of PML linked to Tysabri.

The AP (9/22) reported that the FDA "says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri [natalizumab]." The reports "are the first confirmed new cases since June," and since mid-2006, there "have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML." The AP adds that "the FDA says the risk appears to increase as patients remain on Tysabri" and all "the PML cases are linked to its use in multiple sclerosis."

The Wall Street Journal (9/23, Armstrong) also reports on how the cases of PML will affect Biogen Idec Inc., the maker of Tysabri, and its stock.

Shortage of Tamiflu seen nationwide.

The Tennessean (9/23, Sanchez) reports, "Public demand for" Tamiflu (oseltamivir) "has caused a shortage of the children's dosage" nationwide, and some pharmacies "have run out of Tamiflu in the liquid form." The Tennessean notes, "Until more liquid prescription can be manufactured, pharmacists must convert the adult dosage capsules into a liquid by following FDA-approved guidelines on mixing." Meanwhile, health officials "are concerned that if more liquid is not commercially made soon, the items needed for the makeshift version also could run short."

Study suggest lack of health coverage contributes to 45,000 deaths annually.

Study suggests lack of health coverage contributes to 45,000 deaths annually.The CBS Evening News (9/17, story 7, 2:20, Couric) reported, "While the debate goes on over the cost of insuring everyone, a new study reveals the cost of not doing it." Harvard investigator Steffie Woolhandler, MD, MPH, was shown saying, "We found that 45,000 Americans are dying annually due to lack of health insurance." According to the Boston Globe (9/18, Cooney), "researchers from Cambridge Health Alliance reported yesterday in the American Journal of Public Health on a study that followed 9,005 adults under 65 years old" who took part in a national CDC survey "from 1986 through 1994. After 12 years, 351 people had died. Sixty of them were uninsured, and 291 were insured." MedPage Today (9/17, Walker) explained that the researchers adjusted for such factors as "obesity, exercise habits, alcohol use, and smoking status"; and determined that "those without insurance were 40-percent more likely to die than those with a private insurance plan." Among the other factors that increased the risk of death were "clinically verified poor health (222 percent), smoking (102 percent), being a former smoker (42 percent), and being a male (40 percent)." The New Mexico Business Weekly (9/17) pointed out that the study "disputes a previous one conducted by the Institute of Medicine (IOM), which, in 2002, estimated that some 18,000 Americans between the ages of 25 and 64 died each year because of a lack of health insurance." The New York Times (9/17, Abelson) "Prescriptions" blog noted that the study attributed the increase in risk to "at least two factors. One is the greater difficulty the uninsured have today in finding care, as public hospitals have closed or cut back on services. The other is improvements in medical care for insured people with treatable chronic conditions like high blood pressure. 'As healthcare for the insured gets better, the gap between the insured and uninsured widens,' Dr. Woolhandler said." Reuters (9/18, Heavey) provides excerpts of an interview it did with co-author Dr. David Himmelstein of Harvard. In comparing the IOM study to the new Harvard study, Himmelstein attributed the increased mortality risk to the fact that the rate of uninsured has increased by approximately 2 billion since the initial study. Meanwhile, according to HealthDay (9/18, Pallarito), the National Center for Policy Analysis (NCPA) released a statement calling the "Harvard research 'flawed.'" NCPA CEO John C. Goodman said the findings "are based on faulty methodology and the death risk is significantly overstated. The subjects were interviewed only once and the study tries to link their insurance status at that time to mortality a decade later. Yet over the period, the authors have no idea whether subjects were insured or uninsured, what kind of medical care they received, or even cause of death." Near the end of the aforementioned CBS Evening News (9/17, story 7, 2:20, Couric) clip, Goodman was shown saying, "I think you can't trust the results. Having said that, we ought to do something for the uninsured."

FDA requires boxed warning for promethazine.

FDA requires boxed warning for promethazine.

The AP (9/17, Johnson) reports, "Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation," according to the FDA. Regulators said that "makers of generic promethazine will have to put a [boxed] warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

MedPage Today (9/16, Peck) reported, "The new label also warns that there is 'a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.'"

Medscape (9/16, Rebelo) reported, "The FDA is also requiring a revision in the Dosage and Administration section of the drug's labeling to highlight 'specific recommendations for the maximum concentration (25 mg/mL) and rate of administration (25 mg/min) when intravenous administration of promethazine is required.'"

FDA says Tysabri linked to 13 cases of PML since 2006 re-introduction.

Bloomberg News (9/17, Larkin) reports, "Biogen Idec Inc. and Elan Plc's Tysabri [natalizumab] has been linked to 13 cases of a deadly brain disease" -- progressive multifocal leukoencephalopathy (PML) -- "since the drug was reintroduced in July 2006, regulators said." The FDA on Wednesday posted on its website new "safety information for the treatment for relapsed multiple sclerosis and Crohn's disease."

The Dow Jones Newswire (9/17, Gryta, subscription required) adds that Tysabri's label has not changed and the FDA said that the overall rate of patients developing PML is below the one-in-1,000 rate listed on the drug's label. Still, the agency warned that the risk of PML "appears to increase with the number of Tysabri infusions received," and that 25 was the average number of infusions received before the PML diagnosis.

FDA says Allergan's Latisse website omits risk information.

The Wall Street Journal (9/17, Favole, subscription required) reports that the FDA said Allergan Inc.'s website for Latisse, its eyelash thickener, omits risk information about the product. A Sept. 10 letter to Allergan stated that the company's website lacks information about the risk of bacterial keratitis from using Latisse.

Bloomberg News (9/17, Larkin) reports that regulators said, "Materials that promote a drug's benefits must also address its risks, which in this case include allergic reactions or hair growth outside the treatment area." The FDA "ordered Allergan to reply by Sept. 24 with a plan to discontinue use of these types of promotions."

The Orange County Business Journal (9/16, Reed) reported, "Allergan said that it's working closely with the FDA to address the concerns," and that "it's no longer using an exhibit that described the evolution of lash enhancers, which drew the regulators' objections." Reuters (9/17, Richwine) also covers the story.

FDA approves four H1N1 vaccines.

FDA approves four H1N1 vaccines.

The Wall Street Journal (9/16, Dooren, Favole, subscription required) and many other news sources report that HHS Secretary Kathleen Sebelius announced Tuesday that the FDA has approved H1N1 vaccines made by Novartis AG, a unit of Sanofi-Aventis SA, CSL Ltd., and MedImmune, an AstraZeneca PLC unit.

ABC World News (9/15, story 8, 0:20, Gibson) added that "the government is aiming for a rollout by early next month, and says there should eventually be enough vaccine available for everyone."

In its lead story, CBS Evening News (9/15, lead story, 2:50, Couric) called it "the biggest immunization campaign in US history.

Sebelius announced the approvals at a hearing of the House Energy and Commerce Committee, saying that "some vaccine might arrive by the first week in October, with 'ample supplies' by mid-October," the Miami Herald (9/15, Tasker) reports. She said, "It appears that the vaccine we're producing is working quite well."

CDC director Thomas Frieden, MD, also noted the timeline, saying, "We think the first doses of some of the vaccine forms should be available in about three weeks," CNN (9/16) reports. "Previously, the CDC had been predicting the vaccine would not be available before middle or late October."

The Los Angeles Times (9/16, Maugh) adds that the US "has ordered enough vaccine for 195 million doses, meaning that 'we will have enough vaccine available for everyone,' Sebelius said." The vaccines "will be shipped to national distribution centers," USA Today(9/16, Sternberg) explains. The shots will then become available at outlets such as "public health clinics, doctors' offices, schools, pharmacies, and grocery stores" depending on the state.

NBC Nightly News (9/15, lead story, 2:40, Williams) noted, however, that due to "problems with a 1976 vaccination campaign against a different swine flu threat...Sebelius heard questions today about the safety of the new vaccine." She told Congress, "We are assured by the scientist that lots of steps have been taken along the way to make sure that this will be a safe procedure."

And according to the AP (9/16, Neergaard), Sebelius also said that physicians should not "hand out prescriptions for anti-flu medicines to be used to prevent flu... because 'it could make them sicker in the long run.'" She "stressed" that "Tamiflu and Relenza should be used for treatment only."

Apart from the four vaccines approved Tuesday, Sebelius "fully anticipate[s]" a fifth form of the vaccine to be licensed, Bloomberg News (9/16, Larkin) notes. Bloomberg adds that GlaxoSmithKline PLC is likely the manufacturer of that vaccine.

Until the approved vaccines arrive, "HHS is urging all individuals to get their seasonal flu shots now," CQ HealthBeat (9/16, Attias, subscription required) reports. CongressDaily (9/16, Kivlan, subscription required), New York's Newsday (9/16, Ricks), the South Florida Business Journal (9/16, Raubner), and the Dow Jones Newswire (9/16, Horobin) also cover the story.

Leading News in Pharmacy

Research indicates metformin combined with doxorubicin may kill breast cancer stem cells, delay recurrence.

The Wall Street Journal (9/15, Winslow, subscription required) reports that the diabetes drug metformin, when combined with chemotherapy drug doxorubicin, may shrink breast-cancer tumors and keep them from coming back more effectively than chemotherapy alone, according to a study published in the journal Cancer Research. Researchers reported that the combination treatment killed cancer stem cells in addition to regular cancer cells.

HealthDay (9/14, Gardner) noted that for the study, researchers treated "mice with breast cancer" with metformin and doxorubicin simultaneously. The mice "showed reductions in tumor size in four types of breast cancer, as well as longer remission times."

Notably, "mice treated with the combination" remained "cancer-free for four months, unlike mice treated with either drug alone," WebMD (9/14, DeNoon) reported. The researchers also noted that "metformin and standard chemotherapy" may "make each other work better," so "metformin could be used with lower doses of chemotherapy." AFP (9/14) also covered the story.

H1N1 vaccinations scheduled to begin in three weeks in US.

H1N1 vaccinations scheduled to begin in three weeks in US.

Bloomberg News (9/14, Randall, Gale) reports, "Swine flu vaccinations may begin in three weeks, earlier than previously anticipated, after the first US tests found a single shot to be effective in eight to 10 days, US health officials said. The first shots may be available by the end of this month and administered to patients the first week of October, said Nancy Cox, director of the flu division at the US Centers for Disease Control and Prevention in Atlanta." Previously, "health officials had...planned for vaccinations to begin in mid-October, requiring two shots administered three weeks apart." The piece continues to describe early outbreaks in the US, and relates the testing procedures that led authorities to determine that a single dose would be sufficient to inoculate patients.

HHS Secretary Kathleen Sebelius also said that "the nation's first round of swine flu shots could begin sooner than expected, with some vaccine available as early as the first week of October," the AP(9/14) reports. She said, "We're on track to have an ample supply rolling by the middle of October. But we may have some early vaccine as early as the first full week in October. We'll get the vaccine out the door as fast as it rolls off the production line."

Sebelius "said she is confident that an ample supply of H1N1 vaccine shots will be available to the public by mid-October," the Washington Times (9/14, Lengell) adds. Her "optimism is a shift from last month, when the government was bracing for production delays of the vaccine." This year, "flu viruses are circulating unusually early," though of the cases reported, "98 percent are from H1N1, said Dr. Anne Schuchat of the Centers for Disease Control and Prevention."

USA Today (9/14, Sternberg) notes Sebelius' comments, adding that "Nancy Cox of the Centers for Disease Control and Prevention said the first shipments will be small and reserved for priority groups such as young people and pregnant women." Cox "said evidence that one shot offers protection was a big confidence-booster that prompted the government to speed up its timetable." Bloomberg News (9/14, Murray) and Voice of America (9/14) also report on Secretary Sebelius' comments.

Study indicates peramivir may be as effective against flu as Tamiflu. The AP (9/14, Marchione) reports, "Researchers delivered a double dose of good news Sunday in the fight against flu: successful tests of what could become the first new flu medicine in a decade, and the strongest evidence yet that such drugs save lives, not just shorten illness. A single intravenous dose of the experimental drug, peramivir, cleared up flu symptoms as well as five days of Tamiflu pills did, a large study in Asia found." The piece continues to detail other research presented at an American Society for Microbiology conference in California on Sunday, including studies pointing to the lifesaving utility of Tamiflu. The conference "is the first big meeting of infectious disease specialists since the new H1N1 swine flu emerged in April. Treatment options are getting huge attention because it will take a month or more for people to get swine flu vaccine and have time to develop immunity from the shot."

Drug Approvals

FDA approves antibiotic telavancin.

Bloomberg News (9/12, Matsuyama) reported, "Theravance Inc. and Astella Pharma Inc. said they received US approval to market a new antibiotic for hard-to-treat skin infections such as methicillin-resistant Staphylococcus aureus, or MRSA." The FDA approved telavancin as "a once-daily infusion," which will "be sold as Vibativ."

The San Francisco Business Times (9/13, Leuty) reported that the approval includes "a 'black box' warning for pregnant women." The FDA sought "more data" from Theravance "even after an advisory committee late last year signed off on telavancin" because MRSA "has become increasingly resistant to generic vancomycin." Reuters (9/14, Nishitani) also covers the story.

FDA approves diabetic insulin spray for IND program.

MedPage Today (9/11, Petrochko) reported, "The FDA has approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program." The spray "delivers prandial insulin orally through a device similar to an asthma inhaler, which sprays it on the inside of the cheek." MedPage added, "Researchers have spent much time looking for alternative means of dispensing insulin to diabetics, and the IND program allows patients with serious or life-threatening conditions, and without suitable alternative treatment, to access drugs otherwise available only to those in a clinical trial."

Clinical trials suggest only one H1N1 vaccine dose may be needed in adults.

ABC World News (9/10, story 4, 2:10, Besser) reported that the New England Journal of Medicine...published results of a vaccine trial out of Australia" of "the new swine flu vaccine and it was done in adults. And what they found was that one dose of the vaccine was enough to give protective immunity." Previously, federal researchers "were saying you might need two," the CBS Evening News (9/10, story 6, 0:15, Couric) reported. The vaccine is expected to be ready by mid-October."

On its front page, the New York Times (9/11, A1, McNeil) reports that the results indicate "the vaccine supplies now being made will go twice as far as had been predicted," which means it may be possible to vaccinate "all the 159 million people that the Centers for Disease Control and Prevention estimate are in the high-risk groups." The first trials involved "a single 15-microgram dose in adults" and were conducted by CSL Limited, an Australian firm. CSL "is under contract to supply millions of doses to the United States government." Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, "said trials now under way under the sponsorship of the National Institutes of Health were showing that adults who got only a single dose were protected within 8 to 10 days, which he said 'corroborates and confirms the exciting data' reported in the Australian study."

The AP (9/11, Neergaard) reports that "scientists had feared that people of all ages would need two shots about a month apart because the new H1N1 strain is so genetically different from normally circulating flu strains that most of the population has little if any immunity."

The Washington Post (9/11, A3, Stein) adds that the "eagerly awaited findings mark the first results from a flurry of studies that scientists have been rushing to conduct to develop a swine flu vaccine. The findings indicate that plans to inoculate millions of Americans...and others worldwide could occur much more quickly and require far less vaccine than officials had feared." Dr. Fauci noted that if two doses were needed, "that would be a major strain on vaccine supplies nationally and globally." HHS plans to "release preliminary results Friday of its vaccine studies." Fauci said NIH's findings "are consistent with the Australian study involving 240 patients and show the response occurs even more quickly -- eight to 10 days -- than the 21 days that study found."

USA Today (9/11, Sternberg) reports that the Australian study "showed that nearly 97 percent of volunteers given a standard dose of the vaccine produced antibody levels that typically protect against flu infection, giving planners the welcome news that they may need less vaccine to save more lives." CNN (9/11) and Bloomberg News (9/11, Randall) also cover the story.

ACTION ALERT

September 10, 2009

Action Needed: Urge Congress to Support Pharmacist Clinical Services

Dear Viewers:

We need your help today. Congress returned to Washington, DC this week and health care reform is on the docket. To find savings and help fund reforms, as the House merges its bills (from the Education and Labor, Energy and Commerce, and Ways and Means committees) and as the Senate merges its bills (from the Health, Education, Labor and Pensions, and Senate Finance committees), we anticipate that Members of Congress will cut programs from the current health care reform (HCR) proposals. We do not want to be among the cuts.

Regardless of how Congress decides to expand or fund access to the health care system, we must take advantage of this opportunity to improve the quality of care and lower health care costs by improving patient access to pharmacist clinical services. It is a critical time for pharmacy to demonstrate its support for the pharmacy-related provisions in the health care reform proposals.

The Issues

While APhA supports several provisions in each proposal, we are focused on three priorities that improve patient access to pharmacist clinical services that are included in the House

Tri-Committee, House Energy & Commerce (E&C) Committee, and the Senate Health, Education, Labor and Pensions (HELP) Committee proposals. These provisions would:

• Include Pharmacists as Part of Integrated Care Models (House Tri-Committee Section 1301; Senate HELP Section 212);
• Include Pharmacists in Payment for Transitional Care Activities (House Tri-Committee Section 1151; Senate HELP Section 216); and
• Conduct a Medication Therapy Pilot (House E&C: Congressman Butterfield (D-NC) Amendment; Senate HELP Section 213)

The Action

Make your voice heard in this critical debate that affects the future of the profession. Please take a moment to contact your Members of Congress and express your support for pharmacist clinical services as a part of any health care reform proposal.

Take Action Now

Thank you in advance for your support.

Surgeon goes crazy and cuts off patient's penis and slices it into three pieces

A surgeon in Romania suddenly went crazy and cut off a patient's penis and sliced it into three pieces. He was supposed to have operated on the man's testicles.

The doctor, Naum Ciomu, was a senior doctor and also worked at the University teaching anatomy.

Head of Bucharest's emergency hospital, Sorin Oprescu, said "We are shocked by what has happened. It is the first time we have had such a case."

The patient had a testicular malformation and was being operated on by Dr. Ciomu. The patient was rushed for emergency reconstructive surgery.

The plastic surgeon who is trying to restore the patient's organ said he may be able to restore his urinary function, but doubts whether the man's penis will ever be able to perform sexually.

The patient's wife is suing the doctor.

Td

Right now we screen for Td in triage if there is an open cut or burn. If they have not had Td in the past 5 years we re-vaccinate. If the patient is male we give Adacel if no documented TdaP was given previously. If female and we have a negative preg test we give Adacel, otherwise we give Td. These policies only apply to patients > 18yo.

Angela Cortese PharmD

Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

The Los Angeles Times (9/4, Maugh) reports, "After nearly two decades of futile searching for a vaccine against the AIDS virus," scientists at the Scripps Research Institute "are reporting the tantalizing discovery of antibodies that can prevent the virus from multiplying in the body and producing severe disease." Interestingly, the broadly neutralizing antibodies, or bNAbs, "target a portion of HIV that researchers had not considered" during prior experiments, according to the paper published online in Science. What's more, the target "is a relatively stable portion of the virus that does not participate in the extensive mutations that have made HIV able to escape from antiviral drugs and previous experimental vaccines."

The scientific community has been diligent in its vaccine quest, according to the Wall Street Journal (9/4, Naik, subscription required). Since 1987, researchers throughout the world have had a hand in nearly 100 trials, but they were thwarted in every single one. The biggest setback came in 2007 when a Merck trial yielded an experimental vaccine that actually seemed to increase the risk of infection. Accordingly, funding began drying up, as evidenced by a 10 percent decrease in annual investments in 2008.

One New York-based nonprofit remained undeterred, however. In 2006, Bloomberg News (9/4, Waters) reports, the International AIDS Vaccine Initiative "kicked off an effort dubbed Protocol G, aimed at searching for antibodies that can neutralize the strains of HIV that circulate in the developing world, where the majority of new infections are taking place." Working alongside "doctors and clinics in Thailand, Australia, the US, the UK, and especially Africa, where two-thirds of the world's infected people live, the group collected blood samples from 1,800 people who had been infected with HIV for at least three years without developing symptoms."

Using the "latest biological and computational screening techniques, which emerged from genome-sequencing technologies," investigators screened the "virus-laden samples against B cells to see how many of the HIV strains the immune cells would recognize," Time (9/3, Park) reported. "To their surprise, the B cells were able to neutralize a fair number of the viruses, but two of the antibodies produced by the cells clearly stood out as more potent than the rest" -- PG9 and PG16.

The "two new bNAbs...seem to be different for" a few reasons, the San Diego Tribune (9/3, LaFee) pointed out. Most notably, they "were isolated from...donors in developing countries where HIV is most active." They also "appear to attack a part of the HIV virus that doesn't mutate much, if at all." Lead investigator Dennis Burton said, "It looks like (they) target a particular region on the tops of these surface spikes that stud the viral surface." And, "these spikes are important to the virus because it uses them to interact with or bind to target cells." Simply put, these "antibody-vulnerable areas of the spikes may be the virus' Achilles heel." HealthDay (9/3, Mundell) and Reuters (9/4, Fox) also covered the story.

Drug Approvals

FDA approves guanfacine for AD/HD in children, adolescents.

The Philadelphia Business Journal (9/3, George) reported, "The Food and Drug Administration granted marketing approval Thursday to Shire for Intuniv [guanfacine], a nonstimulant treatment for attention-deficit hyperactivity disorder in children and adolescents aged six to 17." Shire "already has three other ADHD treatments in the United States and two AD/HD medicines outside the United States."

HealthDay (9/3, Roberts) reported that Shire said its "once-daily drug, to be available in 1-to-4 mg. strengths, is expected on pharmacy shelves in November." Reuters (9/4) also covered the story.

Quality and Safety

Single-dose swine flu vaccines raise efficacy questions.

Bloomberg News (9/4, Randall) reports, "Americans may need two vaccine doses instead of one to be immunized against swine flu because officials plan to exclude ingredients used to boost immune responses in shots made by Novartis AG and GlaxoSmithKline Plc." Novartis yesterday said "a single dose of its vaccine, which relies on a shot-boosting ingredient known as an adjuvant, safely provoked a strong immune response in a trial of 100 healthy volunteers." However, Frieden said the "formulation favored by the US doesn't use an adjuvant, and a second vaccine dose is more likely to be required." Bloomberg adds that "adjuvants are controversial because some studies show they cause immune disorders in mice."

According to the AP (9/3), it's unclear what the Novartis trial "would mean for the global swine flu supply," since the Novartis "vaccine was made using cell culture, while about 90 percent of the world's flu vaccines are made using chicken eggs." But the Wall Street Journal (9/4, Bart, subscription required) notes that the cell-based production method that Novartis uses is faster than the egg-based method.

Regulatory

Judge rules Elan-J&J deal breaches Tysabri contract with Biogen.

The Wall Street Journal (9/4, B4, Gryta, subscription required) reports that a US judge ruled that a deal between Elan PLC and Johnson & Johnson breaches a contract with Biogen Idec Inc. over the multiple sclerosis treatment Tysabri [natalizumab]. At issue is J&J's July agreement to purchase 18.4 percent of Elan.

"Biogen and Elan have an agreement that if one is acquired, the other has an option to buy its rights to Tysabri," the Boston Globe/Bloomberg News (9/4, Weidlich) reports. Under the J&J deal, therefore, "Elan assigned its right to J&J in the event that Biogen were ever acquired," Biogen argued. The judge said that "it appears to the court that Elan has designated an obligation it has to [J&J] by taking direction from [J&J] on the purchase-price negotiations." Although "no assignment of rights took place, 'it would seem there has been a breach of the Biogen-Elan collaboration agreement,'" the judge ruled. Elan was given "23 days to fix the breach." Reuters (9/4) also covers the story.

Report indicates most drugmakers meeting federal requirements for post-marketing studies.

The Dow Jones Newswire (9/4, Favole) reports, "Drug and biologics makers are generally keeping up with federal requirements to conduct studies after the Food and Drug Administration approves a medicine," according to a report from consulting firm Booz Allen Hamilton. The "review of more than 1,500 open post-marketing reviews" showed that over "89 percent of the studies are either meeting established deadlines, have been submitted to FDA for review, or have already been completed." In 2007, "Congress gave the FDA new authority...to require companies to continue studying and testing a medicine after it has been approved when health officials have lingering questions about the product's effectiveness or safety."

MedPage Today (9/3, Gever) reported that the review found "more than 750 studies -- nearly half of the 1,531 in the agency's backlog as of 2007 -- were erroneously listed as 'pending,' meaning they had not begun." But, "the agency has since acted on more than 200 post-marketing studies submitted by drug firms that had languished at the agency," of which "the overwhelming majority satisfied the agency's requirements." In fact, "only 211 remained" pending "after the audit." Reuters (9/4) also covers the story.

Technology

Grants allocated for technology-based programs to reduce medication nonadherence.

Healthcare IT News (9/3, Monegain) reported, "The Center for Technology and Aging has released guidelines for a $500,000 grants program aimed at using technology to help reduce patients' failure to adhere to prescribed medication regimens." The Medication Optimization Diffusion Grants Program "provides up to six one-year grants to organizations successfully proposing programs that directly benefit older adults," and four "or five grants will focus on Californians, while one or two may be awarded to other regions of the country." The center said that drug-related hospitalizations "cost $47 billion annually."

Obama plans detailed healthcare address as White House seeks Sen. Snowe's backing.

The Washington Post (9/4, A4, Kornblut) reports that "administration officials promised" that the President will next week "deliver a detailed prescription for reform despite the risks of spelling out exactly where he stands." Vice President Biden said the speech "will map out 'in understandable, clear terms what our administration wants to happen with regard to healthcare, and what we are going to push for specifically.'" Senior administration officials said the speech "will satisfy demands" that Obama "clarify which provisions he supports and which he could jettison. The contents of the speech are largely decided, officials said." The Post also reports the White House is focusing on winning the support of Sen. Olympia Snowe (R-ME), "who they view as the Republican most willing to reach an agreement with the White House. On Thursday, aides to Snowe confirmed that the senator is talking with administration officials, particularly with regard to her 'safety-net fallback option.'" That plan would have the government "sponsor a nonprofit insurance plan but it would become available only in states or regions where private insurance firms had failed to offer a reasonably priced product that would be affordable to 95 percent of the population."

Health Business

Dainippon seeks to tap US drug market with Sepracor purchase.

The New York Times (9/4, B4, Nicholson) reports, "Dainippon Sumitomo Pharma of Japan said Thursday that it would buy the American drugmaker Sepracor for $2.6 billion, as it seeks to tap sales in the United States and increase the products in its pipeline." Sepracor's board unanimously approved the acquisition, and will "be made with a cash tender offer for Sepracor common shares valued at $23 each, or more than 25 percent above their closing price Monday." The Times notes, "Japan's pharmaceutical industry has been especially ambitious in the United States."

The AP (9/4) also reports, "The Japanese drugmaker said the deal will give it access to Sepracor's established sales network of about 1,325 people in the US, which will help it establish a sales platform for lurasidone, a potential treatment for schizophrenia that is now in late-stage trials." Dainippon pointed out "that the acquisition of Sepracor will also increase its overseas revenue to 40 percent of its total."

The Boston Globe (9/4, Wallack) also notes that Sepracor "vowed to maintain" its Massachusetts operations. The Wall Street Journal (9/4, M12, Simms, subscription required), the Boston Business Journal (9/3, Donnelly), Modern Healthcare (9/3, Evans, subscription required), and the Chicago Tribune (9/4) also covered the story.

Bayer to pay Algeta as much as $800 million for Alpharadin.

Bloomberg News (9/4, Von Schaper) reports, "Bayer AG agreed to pay Algeta ASA as much as $800 million for the rights to an experimental cancer medicine known as Alpharadin [radium-223]." The companies will "jointly develop the medicine," and Algeta "will get $61 million in cash, as well as development and sales payments tied to the drug's success." Bayer also said the drug, which is in a Phase III clinical trial, is being tested on patients whose prostate cancer has spread to the bone and "may also battle several forms of cancer that have spread to the bone."

Forest Laboratories paid Minnesota physicians more than $750,000, analysis indicates.

The AP (9/3) reported that "an analysis by a nonprofit group shows a drug company paid Minnesota doctors more than $750,000 in 2008." In fact, "Forest Laboratories Inc. paid 62 Minnesota doctors at least $1,000 each in speakers' fees, with 28 physicians receiving payments of more than $10,000," the Minneapolis Star Tribune (9/3, Moore) reported." The Star Tribune pointed out that "Minnesota was the first among a handful of states requiring drug companies to disclose payments to doctors, and the annual disclosure reports have repeatedly revealed potential conflicts of interest in the way physicians prescribe drugs or conduct clinical research, while adding fuel to a national debate about greater disclosure of the financial ties between industry and" physicians. Nearly one-third "of Forest's payments went to psychiatrists and neurologists, frequent prescribers of antidepressants."

Also in the News

Florida to use portion of Pfizer settlement funds to reward those reporting Medicaid fraud.

The Miami Herald (9/4, Shah) reports, "Florida will use part of its $58 million share of a federal settlement from pharmaceutical giant Pfizer as reward money for tipsters who report Medicaid fraud." The state will use "about $1 million" of the $58 million it received in the settlement to "reward informants whose tips lead to fines, civil or criminal charges or forfeitures of property." Some of the remaining funds "will reimburse the federal Medicaid program for Florida and the state Medicaid program, and nearly $10 million will go into the state's general fund."

Leading News in Pharmacy

Pfizer agrees to $2.3 billion drug-marketing settlement.

The CBS Evening News (9/2, story 5, 0:15, Rodriguez) reported that on Wednesday the government "hit Pfizer, the world's largest drugmaker, with a record $2.3 billion in fines for violating federal drug marketing rules. Among other things, Pfizer was accused of promoting the pain medication Bextra [valdecoxib] for unapproved uses."

NBC Nightly News (9/2, story 6, 0:30, Williams) added that the penalties come from "admitting that the painkiller Bextra and 12 other drugs were promoted for what's known as off-label use, which the FDA says put public health at risk in the process."

ABC World News (9/2, story 2, 2:25, Gibson) reported that "Bextra became a blockbuster, bringing in $1.2 billion a year, as sales reps assured doctors it could be used not just for arthritis, but for any acute pain. The main whistleblower, a former company sales rep, said in a statement, 'at Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that.'" Meanwhile, "in exchange for hearing company sales pitches, doctors were paid up to $1,500 to attend meetings, and were treated to conferences at lush resorts, given air fare, hotels, meals, even massages."

The Washington Post (9/3, Johnson) reports, "Officials at the departments of Justice and Health and Human Services called the agreement with Pfizer and one of its subsidiaries a cautionary example of their strategy to team up with states to police errant healthcare businesses."

"The Justice Department described Wednesday's settlement as the largest in its history," according to the Los Angeles Times(9/3, Meyer). "The settlement reflects an emphasis by the Obama administration on holding US healthcare corporations accountable for their activities, especially in trying to market drugs to patients and doctors for uses that have not been approved, Justice Department officials and legal experts said."

The New York Times (9/3, Harris) adds, "Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud."

Pfizer subsidiary Pharmacia & Upjohn "must pay a $105 million criminal fine" under the agreement, USA Today (9/3, Rubin) reports. "Pfizer "will pay a criminal fine of $1.195 billion" and "has agreed to pay $1 billion in civil damages and penalties to compensate federal healthcare programs for false claims submitted as a result of its marketing Bextra and the other [three] drugs for off-label use or at unapproved dosages." The three other drugs include "Geodon [ziprasidone], an antipsychotic; Zyvox [linezolid], an antibiotic; and Lyrica [pregabalin], an anti-epileptic drug."

The Wall Street Journal (9/3, B2, Rockoff, Kendall, subscription required) noted that the settlement is the third since 2002 in which Pfizer has promised to change its marketing practices. The AP (9/3, Barrett), the Washington Times (9/3, Conery), the Philadelphia Inquirer (9/2, Hill), the Dow Jones Newswire (9/3, Kendall), Reuters (9/3, Berkrot) and Bloomberg News (9/3, O'Reilly, Capaccio) also cover the story.

Regulatory

Jurors consider Merck's Fosamax case.

On the front page of its Business Day section , the New York Times (9/3, B1, Singer) reports, "Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug" used "to offset the bone loss associated with menopause." The case "is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop...osteonecrosis of the jaw." In the current case, the plaintiff, Shirley Boles, "alleges that taking Fosamax from 1997 to 2006 caused her jawbone tissue to die." Merck is currently "trying to complete a $41 billion merger with Schering-Plough," and "industry analysts are closely watching this first trial to gauge Merck's potential financial liability."

The Wall Street Journal (9/3, Bray, subscription required) reports that an attorney for Merck claims Boles' osteonecrosis occurred three years after she stopped taking the drug. Boles, therefore, cannot blame Fosamax for having caused the condition, the attorney contended. Merck is accused of misrepresenting "the drug's safety and" failing "to warn doctors and patients that it might hamper blood flow to the jaw," Bloomberg News (9/3, Weidlich, Fisk) reports. Plaintiffs also contend that Merck failed "to include an adequate warning about Fosamax's risks when the label was changed." Reuters (9/3, McCool) also covers the story.

FDA panel recommends approval for pralatrexate.

The AP (9/3) reports, "A spokeswoman for the Food and Drug Administration said the agency's panel of oncology experts voted 10-4 that [Allos Therapeutics'] drug pralatrexate [Folotyn] would likely benefit patients with T-Cell lymphoma." Allos "has asked the FDA to approve its drug for patients whose cancer reoccurs or has not responded to other drugs," and there are "currently no FDA approved treatments for the disease." The company's "studies of the drug showed 27 percent of patients with T-Cell lymphoma responded to treatment, with more than half responding for about three months." The FDA is expected to decide on the drug by Sept. 24.

Reuters (9/3, Heavey) adds that the FDA, which is reviewing the drug under an expedited process, also cautioned the panel that while the drug seems to have some active effect on T-Cell lymphoma, that effect alone may not be enough to merit approval.

Knopp receives FDA fast track designation for ALS drug.

The Pittsburgh Business Times (9/2) reported, "Knopp Neurosciences Inc. has received fast track designation from the Food & Drug Administration for development of a drug to treat amyotrophic lateral sclerosis, better known as Lou Gehrig's disease." The company "has completed the randomized, placebo-controlled part of its phase two studies of the drug in 102 ALS patients and anticipates starting third-phase studies in the United States and Europe next year." Those participating in the second phase of the study "were offered enrollment in an ongoing, 48-week safety trial, where all participants are receiving the highest dose tested of the Knopp drug, which is known as KNS-760704."

FDA extends review of Endo's Nebido by three months.

The AP (9/3) reports, "The Food and Drug Administration has extended a review of a testosterone drug candidate by three months, the product's maker, Endo Pharmaceuticals Holdings Inc., said Wednesday." The agency "extended its review period to Dec. 2," because it "needs more time to review the application and complete a risk evaluation and mitigation strategy." The drug, Nebido, "a long-acting testosterone undecanoate injection," is "intended to treat hypogonadism."

The agency "has not requested additional data" from Endo, the Philadelphia Business Journal (9/2, George) reported. Nebido is currently "approved in 86 countries worldwide." The drug "was discovered and developed by Bayer Schering Pharma," which "licensed the US rights to the product to Indevus Pharmaceuticals." Endo acquired Indevus "earlier this year." Reuters (9/3, Raj) also covers the story.

Health Coverage and Access

Obama to address joint session of Congress on healthcare reform.

The White House announced Wednesday that the President will deliver a speech to a joint session of Congress next Wednesday night on the issue of healthcare reform. The AP (9/2, Babington) reports that the speech opens "an urgent autumn push to gain control of the debate that has been slipping from his grasp under withering Republican-led attacks." The Administration's "scheduling of the speech next Wednesday night, just a day after lawmakers return from their August recess, underscores the determination of the White House to confront critics of Obama's overhaul proposals and to buck up supporters who have been thrown on the defensive." The timing "also suggests that top Democrats have all but given up hope for a bipartisan breakthrough." The Christian Science Monitor (9/3, Feldmann) reports that "at this point, talk of a bipartisan plan has evaporated. So, analysts say, what he needs to do is unite his own party, in both houses of Congress, and proceed from there."

The New York Times (9/3, A1, Pear, Calmes) reports on its front page that Administration officials said the President "would be more specific than he has been to date about what he wants included in the plan. Doing so amounts to an acknowledgment that the president's prior tactic of laying out broad principles and leaving Congress to fill in the details was no longer working and that Mr. Obama needed to become more personally involved in shaping the outcome." However, "the officials said Mr. Obama was unlikely to unveil a detailed legislative plan of his own," and "insisted" the President had not given up on a public option.

Health Business

Dainippon to buy Sepracor for $2.6 billion.

Bloomberg News (9/3, Matsuyama, Randall) reports, "Dainippon Sumitomo Pharma Co. will buy Sepracor Inc. for $2.6 billion, gaining a US sales force and experimental treatments in the world's biggest drug market." Sepracor "will become a wholly owned unit of Dainippon after the all-cash transaction is completed," according to statement from the companies. Bloomberg adds, "Sepracor has a sales force of 1,200 in the US and is researching drugs including treatments for asthma, allergic rhinitis and insomnia."

The Dow Jones Newswire (9/3, Shimamura) also notes that if the purchase goes through, "Dainippon would be able to open a sales channel in the US for its new schizophrenia drug [Lurasidone] currently in phase-3 clinical studies."

Abbott to develop diagnostic test for Pfizer drug.

The Chicago Tribune (9/3, Japsen) reports, "To tap the growth potential of personalized medicine, the diagnostic business of North Chicago-based Abbott Laboratories will work with Pfizer Inc. to develop a test to determine which patients will benefit from an experimental lung cancer drug being developed by" Pfizer. Abbott's "companion diagnostic test" will help to "'determine a patient's genetic status and will be used in patient selection for future clinical trials' of Pfizer's PF-02341066, a cancer therapy targeting non-small-cell lung cancer." Abbott did not "disclose potential sales for such a companion test."

Research

Study indicates experimental drug may be promising against basal cell carcinoma.

The Wall Street Journal (9/3, Winslow, subscription required) reports that, according to a study published online Sept. 2 in the New England Journal of Medicine, Genentech's experimental drug GDC-0449 appeared to shrink tumors in 18 of 33 patients in the advanced stages of basal cell carcinoma. The drug also temporarily and dramatically helped a 26-year-old man suffering from medulloblastoma, a brain cancer.

HealthDay (9/2, Gardner) pointed out that GDC-0449 "switches off the so-called 'Hedgehog' pathway." HealthDay noted that "the Hedgehog pathway has been implicated in other cancers, notably colon cancer and ovarian cancer, albeit in a different way." Therefore, investigators "are going forward to look at the potential of...GDC-0449 to treat these types of cancers as a one-drug regimen, and in combination with other drugs for other solid tumor malignancies," explained study author Charles M. Rudin, MD, PhD, of Johns Hopkins University. In an accompanying editorial, Andrzej Dlugosz, MD, professor, department of dermatology, University of Michigan Medical School, "noted that finding a compound that might control the Hedgehog pathway could have far-reaching implications."

WebMD (9/2, DeNoon), MedPage Today (9/2, Bankhead), Medscape (9/2, Chustecka), AFP (9/3), Reuters (9/3, Steenhuysen), and the Arizona Republic (9/3, Alltucker) also cover the story.

Research suggests perioperative statin therapy may be linked to improved cardiac outcomes in vascular surgery.

The AP (9/3) reports that individuals "getting an artery unclogged or repaired were much less likely to die or have a heart attack afterward if they took" statins "before and after their operations," according to a study published in the New England Journal of Medicine. Investigators "enrolled nearly 500 patients who were not on statins and were going to have operations on their aorta or leg or neck arteries. For about a month before and a month after their surgery, half the patients took a statin; the" remaining patients were given a placebo. The researchers found that "within a month of the operation, 12 patients in the statin group, about five percent, had died or had heart attacks, compared to 25 patients, or 10 percent, of those who took a dummy pill."

MedPage Today (9/2, Emery) reported that the participants "who took the statin drug also saw a significant drop in total cholesterol, low-density lipoprotein (LDL) cholesterol, and two biomarkers for inflammation, interleukin-6 and C-reactive protein." HealthDay (9/2, Edelson) also covered the story.

Low doses of investigational, delayed-release version of prednisone may benefit RA patients, trial indicates.

MedPage Today (9/2, Gever) reported, "Low doses of an investigational, delayed-release version of prednisone relieved rheumatoid arthritis symptoms in a pivotal phase III trial" that included 350 patients, "paving the way for a US marketing application," Swiss-based Nitec Pharma announced. Investigators found that nearly "49 percent of the Lodotra group achieved ACR 20 responses (20 percent reduction in symptoms according to American College of Rheumatology criteria), compared with 29 percent of those taking placebo." It also "led to a mean 44 percent reduction in morning stiffness, compared with 21 percent in the placebo group. Both differences were highly significant."

Prazosin may reduce trauma nightmares, study suggests.

MedPage Today (9/2, Neale) reported, "Prazosin, a drug originally developed to lower blood pressure but used to treat veterans with post-traumatic stress disorder for years, appeared to reduce debilitating trauma nightmares in soldiers deployed to Iraq in a small, open-label study." For 13 soldiers "treated at a combat stress unit in northern Iraq, there was a significant reduction in mean scores for trauma nightmares and disturbed sleep." MedPage added, "Mean trauma nightmare score on the Clinician Administered PTSD Scale decreased from 7.0 to 2.9."

Also in the News

Union group asks FTC to investigate CVS-Caremark merger.

Bloomberg News (9/3, Wolf) reports that officials from Change to Win, a six million-member union federation, "said it asked the Federal Trade Commission at a meeting today to investigate whether the 2007 merger that created CVS Caremark Corp. has raised prescription drug prices." The union "alleges CVS overcharges consumers, sells private customer data and favors higher-priced drugs in order to collect manufacturer rebates, assertions the company says aren't true." The union also "joins five US senators who have requested a similar probe."