In the News

Acupuncture Beats Drug to Treat Hot Flashes

Acupuncture works as well as a drug commonly used to combat hot flashes and other menopausal symptoms that can accompany breast cancer treatment, and its benefits last longer, without bad side effects, researchers say. They tested acupuncture against the Wyeth antidepressant Effexor, for hot flashes in breast cancer patients. Forty-seven breast cancer patients took part in the study, about half getting acupuncture and half getting Effexor. The women kept track of the number and severity of hot flashes before, during and after the 12 weeks of treatment. Source: Reuters/Yahoo! News 9/22/08

U.S. Researchers Call Off Controversial Autism Study

A government agency has dropped plans for a study of a controversial treatment for autism that critics had called an unethical experiment on children. The National Institute of Mental Health said in a September 17 statement that the study of the treatment--called chelation--has been abandoned. The study had been on hold because of safety concerns after another study published last year linked DMSA, a drug used in the treatment, to lasting brain problems in rats. The researchers had proposed recruiting 120 autistic children and giving half the drug and the other half a dummy pill for 12 weeks. Source: Associated Press/Yahoo! News 9/17/08

Medical Device Ads Criticized on Capitol Hill

Medical experts told lawmakers in September that new television advertisements for medical devices pose even greater risks to patients than ads for drugs, which have been scrutinized for years. The Senate Aging Committee hearing was focused on whether new restrictions are needed on consumer-directed advertisements for artificial knees, heart devices, and other medical implants. Unlike ads from pharmaceutical companies, medical device spots are not required to give equal balance to risks and benefits of their products. AdvaMed, which represents industry leaders, argued that marketing "is a powerful education tool." Source: Associated Press/Yahoo! News 9/17/08

FDA Bans Imports of Dozens of Indian-Made Drugs

The Food and Drug Administration (FDA) has halted importation of dozens of drugs made by Indian generic drug maker Ranbaxy Laboratories because of manufacturing deficiencies at two of the company's plants. FDA's Center for Drug Evaluation and Research said there was no evidence of harm to consumers from drugs made at the plants. The FDA had earlier sent two warning letters informing Ranbaxy management that inspectors had found numerous deviations from current good manufacturing process--the rules and standards for producing drugs--including inadequate sterile processing operations and record-keeping. Source: Washington Post 9/17/08

New Merck Osteoporosis Drug Boosts Bone Density

An osteoporosis drug being developed by Merck & Co. increased bone density over two years in postmenopausal women with mild osteoporosis, the company reported in September. The drug, odanacatib, increased bone density in a midstage trial by about 5.5 percent in the lower spine, while a comparison group of women getting dummy pills on average had bone density decrease about 0.2 percent from its level at the start of the study. Over the same two years, bone density in women getting the drug increased 3 to 4 percent at the hip and upper thigh bone, while those on dummy pills saw decreases of nearly 1 percent at both sites. Source: Associated Press/Yahoo! News 9/16/08

FDA Expands Use of Cervical Cancer Vaccine

The cervical cancer vaccine Gardasil also works to prevent cancers of the vagina and vulva, federal health officials said in September, as they approved expanding its use to protect against those diseases as well. The Food and Drug Administration (FDA) first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. Some 15,000 women were followed for about two years as part of a clinical study supporting Gardasil's new indications. Source: Associated Press/Yahoo! News 9/12/08

FDA Hires 1,300 New Doctors and Scientists

The Food and Drug Administration (FDA) said in September it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific change. The biggest number of jobs will go to the Center for Drug Evaluation and Research, which assesses new medications and monitors the safety of drugs on the market. That center will get 663 new staffers. About 40 percent of the total number of positions are being funded with industry user fees. Source: Associated Press/Yahoo! News 9/11/08

Medical Schools, Journals Fight Industry Influence

Just about every segment of the medical community is piling on the pharmaceutical industry these days, accusing drug makers of deceiving the public, manipulating doctors, and putting profits before patients. Articles and editorials in medical journals blast the industry, and medical schools, teaching hospitals, and physician groups are changing rules to limit the influence of pharmaceutical sales reps. The industries' dealings remain fraught with potential conflict because the sectors depend on each other so much--medicine on drug makers' research dollars and drug makers on the credibility researchers give them. Source: Associated Press/Yahoo! News 9/11/08

Medical Community Acts to Prevent Pharmaceutical Industry Influence Amid Recent Criticism

Some major universities have begun to examine their policies on funds that they receive from pharmaceutical companies amid criticism from Senate Finance Committee ranking member Chuck Grassley (R-Iowa). The committee has contacted more than 20 universities--such as Harvard, Stanford, Texas, and Brown--about potential undisclosed financial ties between university researchers and pharmaceutical companies that could result in conflicts of interest. Grassley seeks to have the National Institutes of Health withdraw grants from universities that fail to disclose their financial ties to pharmaceutical companies. Source: Kaiser Daily Health Policy Report 9/11/08

FDA Posts List of Potential Problem Drugs

The U.S. Food and Drug Administration (FDA) on September 5 began posting a list of prescription drugs under investigation for potential safety problems. The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be. FDA officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation. Source: Associated Press/Yahoo! News 9/6/08 See also Washington Post 9/6/08

Patient Power: Some with Incurable Diseases are Helping Find Cures

Over the past 20 years, the Cystic Fibrosis Foundation has put $188 million into research at drug companies, and it is currently involved in human studies of 33 drugs. Inspired by the foundation's success, patient groups with an entrepreneurial bent have become the drug industry's new power brokers. Nearly 100 patient-group-backed drugs, one-twentieth of all the medicines in development, are in human clinical trials for Parkinson's, diabetes, muscular dystrophy, and a litany of cancers. These patient power brokers will give drug companies $90 million this year, 13 times as much as in 2000, according to Thomson CenterWatch. Source: Forbes 9/15/08

Cancer Trials Struggle for Patients, Funds

The medical community in places such as Boston is busy working on hundreds of clinical trials--each one holding the promise of changing the future of cancer treatment. But researchers told Boston television station WCVB they face challenges in both finding willing patients and federal funding. Only 5 to 8 percent of cancer patients will ever be in a clinical trial. Researchers said that can be to the detriment of science and patients. "Doctors sometimes don't even tell patients what clinical trials are available," said one doctor. "And in our day and age, increasingly, patients and their families have to be their own advocates." Source: NBC6.net 9/4/08

Being Unique is a Disorder

Spending too much time on the Internet? Worried about a low sex drive, shyness, lack of social skills, losing your temper too easily, blushing too readily, or spending too much time and money shopping? There was a time when such behaviors might have been regarded as individual differences, or put down to lack of self-control and restraint. But not any more. Increasing numbers of behavioral conditions are being targeted with drugs that are either in clinical trials or already available. For drug companies, this market is potentially huge. But critics argue that some of these treatments amount to medicalization of individual differences and traits. This article was first published in The Independent. Source: Sydney Morning Herald 9/4/08

Heart Bypasses Beat Drug Stents in Study

Patients with difficult-to-treat clogged arteries are better off getting bypass surgery rather than drug stents, according to results of a major clinical study. Both procedures proved equally safe, but those patients receiving Boston Scientific's drug-coated Taxus stent were more likely to need a repeat procedure. The results of the study were presented at the annual meeting of the European Society of Cardiology. The study found that 17.8 percent of patients receiving stents either died, suffered a heart attack, had a stroke, or needed a repeat procedure versus 12.1 percent for those undergoing surgery and receiving coronary artery bypass grafting. Source: Reuters/Yahoo! News 9/1/08

Cell Genesys' Saving Grace

News of high fatalies during one its drug trials has weighed on Cell Genesys' stock price, but the company may be able to overcome the blow if data from a different study helps it gain FDA approval. The company announced recently that it would halt its study of the prostate cancer drug GVAX following a number of deaths. A review of the late-stage human trial showed that there was an imbalance in the deaths of people taking GVAX with Taxotere, a standard chemotherapy, compared to the control group, which was receiving Taxotere with prednisone. Out of the 408 cancer patients in the study, 114 died; 67 were on GVAX while 47 were in the control group. Source: Forbes/Associated Press 8/27/08

Study Outcome Won't Sway Company on Eye Drug

What does a company do when there is anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000? In the case of Genentech Inc., nothing. The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration. Nor would it cooperate with a National Eye Institute study comparing Avastin, a cancer drug, and the more expensive eye drug, Lucentis. Genentech is making no promises that it will act upon the trial's final results, which are expected in two to three years. Source: Associated Press/Washington Post 8/27/08

Human Exoskeleton Suit Helps Paralyzed People Walk

Paralyzed for the past 20 years, former Israeli paratrooper Radi Kaiof now walks down the street with a dim mechanical hum. That is the sound of an electronic exoskeleton moving the 41-year-old's legs and propelling him forward. The device, called ReWalk, comes from Argo Medical Technologies, a small Israeli high-tech company. The ReWalk helps paraplegics--people paralyzed below the waist--to stand, walk and climb stairs. It is now in clinical trials in Tel Aviv's Sheba Medical Centre and will soon be used in trials at the Moss Rehabilitation Research Institute in Pennsylvania. Source: Reuters/Yahoo! News 8/25/08

FDA Investigates Possible Vytorin Link to Cancer

Federal drug safety regulators say they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration (FDA) said patients should not stop taking Vytorin because the evidence of a cancer link is unclear. While one recent clinical trial indicated higher rates of cancer for patients taking the medication, two studies currently under way have shown no increased risk, the FDA said. Meanwhile, senior lawmakers in Congress issued a demand for data on the clinical trial that indicated a cancer risk. Source: Associated Press/Washington Post 8/21/08

Judge: Company Must Give Experimental Drug to Teen

A federal judge has ordered a research company to supply an experimental drug to a 16-year-old Minnesota boy who is terminally ill with a rare form of muscular dystrophy. PTC Therapeutics plans to appeal the ruling. The teenager's family contends that PTC led them to believe he could participate in a clinical trial of the drug, but they say the company then went back on its word. The company maintained that no promises were made. It said that allowing the teen to join the clinical trial would not be safe and would set a bad precedent that could hinder research. PTC also argued that U.S. courts have decided that terminally ill patients have no right to get unapproved drugs. Source: Associated Press/Yahoo! News 8/20/08

Drug Makers’ Push Leads to Cancer Vaccines’ Fast Rise

Cervical cancer has gone from an obscure killer confined mostly to poor nations to the West’s disease of the moment. Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries. Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. Countries and consumers must decide whether it is worth preventing cervical cancer with a costly vaccine. Source: New York Times 8/20/08

Researchers: Merck Vioxx Study Was for Marketing

The primary purpose of a 1999 clinical study that Merck & Co Inc said was done to test side effects of Vioxx was actually to support a marketing campaign before the now-withdrawn painkiller's launch, according to U.S. researchers. The real aim of the study was to promote prescription of the new medicine when it became available--a so-called "seeding" project--the researchers said in August. "Failure to disclose the primary purpose of a trial has ethical ramifications for patients, physicians, and the design of clinical trials," they said. Merck said the purpose of the clinical trial was to test the gastrointestinal tolerability of Vioxx compared to naproxen. Source: Reuters/Yahoo! News 8/19/08

First U.S. Drug for Huntington's Disease Wins Approval

Federal regulators have cleared the first treatment approved in the United States for Huntington's, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities, and, ultimately, death. The medication, called Xenazine, will not cure the condition, and it has some potentially serious side effects, such as raising the risk of suicidal behavior. However, it does provide relief for a major disabling symptom of Huntington's: the jerky, involuntary movements that force many patients to live as shut-ins. The medication had already been approved in Canada, Europe, and Australia. Source: Associated Press/Yahoo! News 8/15/08

Lawsuits Help Guarantee Drug Safety, Doctors Say

The Food and Drug Administration "is in no position" to guarantee drug safety, the editors of the New England Journal of Medicine said in a friend-of-the-court brief to the Supreme Court. Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks. At issue is Wyeth v. Levine. Diana Levine lost her right arm below the elbow after she was injected with Phenergan for nausea and developed gangrene. She sued Wyeth, arguing that the company had a duty to warn consumers that such injections could have devastating consequences. The courts in her state agreed, but Wyeth appealed, countering that it was protected from such lawsuits. Source: Associated Press/Yahoo! News 8/15/08

British Scientists Test First Arthritis Vaccine

British scientists plan to start tests on a novel vaccine against rheumatoid arthritis (RA), which could suppress the effects of the joint condition using patients' own blood cells. A team from Newcastle University will test the effectiveness of the vaccine in eight volunteers in a pilot study. If successful, there will then be larger clinical trials. The new vaccine involves chemical manipulation of a patient's own white blood cells, so that they develop into so-called tolerogenic dendritic cells, which are thought to suppress immune system activity. A similar technique has been used in cancer research, but this is the first time it has been adapted to RA. Source: Reuters/Yahoo! News 8/14/08

Study: Drugs, Angioplasty Give Similar Life Quality

Using drugs alone may take longer than angioplasty or stent surgery to help restore blood flow in patients with clogged arteries, but in the long run patients do just about as well, researchers say. The surgery, known as percutaneous coronary intervention, may provide more short-term relief for some patients with severe or more frequent chest pain, but the benefits tend to fade over the years, the international team of researchers reported in the New England Journal of Medicine. They assessed 2,287 volunteers in 50 U.S. and Canadian medical centers as part of a study called COURAGE. The costs of the two therapies have not been compared, yet. Source: Reuters/Yahoo! News 8/13/08

Biotech Campaigns for Easier Access to Generic Drug Market

Last month, Insmed demonstrated that its version of Neupogen was equivalent in 32 healthy volunteers to the original product from Amgen. But, for Insmed's version, there is no pathway for approval; and some argue the process for such biosimilar products should be different than for chemical drugs. The Biotechnology Industry Organization, as well as the handful of biotechs that control most of the market, supports a 14-year period to allow companies to recoup their investment and conduct further clinical trials to improve the product. Source: Washington Post 8/13/08

Australian Scientists in Potential Leukemia Breakthrough

Australian scientists say they have mapped a blood cell structure that could hold the key to improved drug treatments for diseases such as leukemia, asthma, and rheumatoid arthritis. The researchers say they have created the first three-dimensional image of a protein receptor in white blood cells, which, when malfunctioning, can cause leukaemia. St. Vincent's Institute and the Hanson Institute in Adelaide have signed an agreement with biopharmaceutical company CSL Limited to work to develop therapeutic antibodies. Source: Agence France Presse/Yahoo! News 8/11/08

Gardasil Vaccine Doubts Grow

Though most medical organizations strongly advocate using the HPV vaccine, some doctors and parents are asking whether the vaccine's benefits really outweigh its costs. Although cause and effect were not proved, a report released in June listed serious events among teens, preteens, and young women who had earlier had Gardasil shots. It is not yet proven that Gardasil actually prevents cervical cancer, because tests of the vaccine before the FDA greenlighted it didn't run long enough to prove that conclusively. Source: Los Angeles Times 8/11/08

FDA: Some Cholesterol and Heart Drugs Don't Mix

Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warns. The Food and Drug Administration (FDA) said doctors should use extra care when prescribing Zocor, generic Zocor, or Vytorin to patients who are also taking amiodarone, a heart rhythm drug marketed as Cordarone or Pacerone. The danger is higher for patients taking more than 20 milligrams a day of the cholesterol drugs, the agency said. Source: Associated Press/Yahoo! News 8/8/08

Should Clinical Trials Be Outsourced?

Faced with tight regulations at home and shrinking profits due to expiring drug patents, western drug makers are looking to expedite the process by outsourcing safety and efficacy studies to developing countries, a large proportion of them to India. An amendment proposed last year by the technical advisory committee of India's Health Ministry would further allow drug companies to test their products widely on patients in India before they're proved safe at home, which is causing alarm among sections of civil society. Source: Time 8/7/08

HIV Drugs to be Used in Prevention

Disheartened by the failures of vaccines and microbicides in blocking HIV transmission, some AIDS researchers are now touting a third possibility: using existing HIV drugs prophylactically. By next year, as many as 15,000 people worldwide will be enrolled in trials to test the concept--more than are enrolled in all vaccine and microbicide trials combined--according to a report issued at the International AIDS Conference in Mexico City. There are seven trials under way or planned. Source: Los Angeles Times 8/5/08

Researchers Look to Pill to Avert HIV

Initial findings might come early next year from studies testing tenofovir, either alone or combined with another drug, emtricitabine, in Botswana, Brazil, Ecuador, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, and the United States. Results may be hard to interpret because the tests are being conducted in different ways and so may produce varying findings. Statisticians could face challenges in pooling the data from the trials. Researchers conducting the studies said they were taking longer than initially expected. Source: New York Times 8/5/08

Biogen: Two Patients Get Brain Disease

Biogen Idec Inc. said two more patients taking its promising multiple sclerosis drug, Tysabri, appear to have contracted a rare and potentially fatal brain disease, the first cases since the company reintroduced the treatment two years ago. The firm originally launched Tysabri in late 2004, but yanked it off the market a few months after several patients were diagnosed with a serious brain disease, called progressive multifocal leukoencephalopathy, or PML. Two of the three patients who contracted PML eventually died. Source: Boston Globe 8/1/08

Drug Gives Couch Potato Mice Benefits of a Workout

What if a drug could help you gain some of the benefits of exercise without working up a sweat? Scientists reported recently that there is such a drug--if you happen to be a mouse. Sedentary mice that took the drug for four weeks burned more calories and had less fat than untreated mice. And when tested on a treadmill, they could run about 44 percent farther and 23 percent longer than untreated mice. Some day, such a drug might help treat obesity, diabetes, and people with medical conditions that keep them from exercising. Source: Associated Press/Yahoo! News 7/31/08

Amgen Told to Reword Drug Label

The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs, Aranesp and Procrit, in a way that could further restrict their use in treating patients with cancer. The move represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Sales of the drugs have already plummeted because of studies suggesting that their use to treat the anemia caused by chemotherapy could make cancer worse or shorten lives. Source: New York Times 7/31/08

Drugs to Reverse Alzheimer's Disease Prove Elusive

This year was supposed to herald the arrival of the first Alzheimer's disease-modifying drug--an event which pharmaceutical experts predict will lead to a multimillion-dollar product. Instead, it's been marked by two failed clinical trials--one for the medication shelved in June by Myriad Genetics and one for another drug aimed at arresting the disease. The arrival of such a disease-modifying medication is now unlikely before 2010, perhaps later. Source: Los Angeles Times 7/28/08 For related late-breaking news from the Associated Press, see "Experimental Alzheimer's Drug Shows Early Promise" in the Washington Post 7/29/08.

FDA Faulted Over Unapproved Uses of Medications

When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects. Source: Associated Press/Yahoo! News 7/27/08

Biotech Complex Would be Boston Region's Largest

A developer is proposing to build the largest life sciences complex in New England, a cluster of labs and offices on 250 acres in Burlington, Mass., that would also include retail shops and up to 2,000 units of housing for the elderly. The life sciences part of the development would total 2 million square feet for research laboratories and administrative offices. Though the developer does not have tenants lined up, it's betting the life sciences sector will remain robust and biotechnology companies will continue migrating to the suburbs. Source: Boston Globe 7/22/08

Hoping Two Drugs Carry a Side Effect: Longer Life

Sirtris, a company that works to develop drugs that may extend the human life span and which was bought last month by GlaxoSmithKline for $720 million, has two sirtuin activator drugs in clinical trials. The hope is that activating sirtuins in people would, like a calorically restricted diet in mice, avert degenerative diseases of aging like diabetes, heart disease, cancer, and Alzheimer’s. There is no Food and Drug Administration category for longevity drugs, so if the company is to submit a drug for approval, it needs to be for a specific disease. Source: New York Times 7/22/08

Drug Maker Ills to Drive Growth, Deals in Lab Sector

A strong five-year run by companies that specialize in pharmaceutical testing shows no sign of slowing as struggling drug makers farm out even more business to them in a trend that should drive consolidation. Drug companies stand to save millions of dollars by outsourcing clinical trials to little-known contract research organizations, or CROs, because that lets them avoid hiring researchers and building laboratory space of their own. Some 25 percent of all preclinical drug testing is already outsourced to CROs. Source: Reuters 7/20/08

Vytorin Misses Study Goal

In the latest disappointment for cholesterol pill Vytorin, a major European study in patients with heart valve disease found the drug did not prevent worsening of the disease or lower the need for valve surgery. Results of a preliminary analysis of the just-completed study showed Vytorin, marketed jointly by Merck & Co. and Schering-Plough Corp., was no better than placebo at lowering the risk of major cardiovascular events--including heart attack, stroke, heart surgery, and death--in patients with aortic stenosis. Source: Associated Press/ Yahoo! News 7/21/08

Family Sues Company for Muscular Dystrophy Drug

A Minnesota family is trying to force PTC Therapeutics to give their son an experimental drug for Duchenne muscular dystrophy, saying he'll die without it. The family claims that the company repeatedly promised them their son would have access to the drug, but then broke its word. The company denied ever making that assurance. The family claims the company discouraged them from enrolling their son in a preliminary trial, saying it would not hurt his chances of getting into a later study, but then used his absence from that original trial as a reason to disqualify him from a current study. Source: Associated Press/Yahoo! News 7/18/08

Doctors Hopeful Easier Blood Thinners are Nearing

A trio of experimental drugs has doctors hopeful that for the first time in decades, millions of people at risk of lethal blood clots may soon get easier treatment. The first goal is a pill option for people who now need daily blood-thinning shots for weeks after knee or hip replacement surgery. But the ultimate goal is an alternative to that old standby warfarin, the nation's most troublesome lifesaver because of side effects and restrictions its 2 million users face. Now in late-stage testing are three pills that work to prevent blood clots in ways that promise to be less burdensome. Source: Associated Press/Yahoo! News 7/14/08

Genentech Warns of Anemia in Avastin Combo Trial

Genentech Inc. has warned doctors about a type of anemia seen in patients treated with the company's blockbuster cancer drug Avastin in combination with Pfizer Inc.'s Sutent in a clinical trial. The cases of microangiopathic hemolytic anemia seen in a Phase I kidney cancer study led to the closure of a mid-stage trial of Avastin plus Sutent. Five of 12 patients who received the highest dose of Sutent had laboratory findings consistent with microangiopathic hemolytic anemia. Two of the cases were considered severe with evidence of several adverse side effects. Both cases were reversible within three weeks of discontinuation of the two medicines, Genentech said. Source: Reuters/Yahoo! News 7/14/08 

New Pharma Ethics Rules Eliminate Gifts and Meals

Pharmaceutical Research and Manufacturers of America announced July 10 that it has revised its conduct code for interacting with healthcare professionals. The updated guidelines ban sales representatives from giving out knicknacks bearing company and product logos; bans providing restaurant meals and entertainment or recreation; and emphasizes that drug companies should separate any funding for continuing medical education from their sales and marketing departments. It notes that the funding should support education "on a full range of treatment options and not to promote a particular medicine." The new rules take effect January 1, 2009. Source: Associated Press/Yahoo! News 7/11/08 

U.S., Europe, Australia Unite on Drug Inspections

Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush administration officials said the agreement will allow regulators to coordinate their inspections and share information, thereby covering a wider territory and more foreign facilities. The pilot program will concentrate primarily on facilities in third countries that produce much of the world's pharmaceutical raw materials, but are sometimes beyond the reach of U.S. inspectors. Source: Associated Press/Yahoo! News 7/9/08 

The Evidence Gap: Costly Cancer Drug Offers Hope, but Also a Dilemma

Looked at one way, Genentech's Avastin is a wonder drug for patients with advanced lung, colon, or breast cancer. Despite its price, which can reach $100,000 a year, Avastin has become one of the most popular cancer drugs in the world. But studies show the drug prolongs life by only a few months, if that. And some newer studies suggest the drug might be less effective against cancer than the Food and Drug Administration had understood when the agency approved its uses. The drug is being formally tested in as many as 450 clinical trials for about 30 types of cancer. Source: New York Times 7/6/08 

Do You Want to be a Guinea Pig?

They want to pay me for the use of my body. They want me (and you) to be subjects in medical studies. A poster in my internist's waiting room asks whether I'd be interested in participating in a cholesterol study. In my gynecologist's waiting room, another poster tries to recruit ladies for studies on prenatal vitamins and on vulvar vestibulitis. On my way home from work, I hear radio ads for studies on medications for depression. Diane Simmons, president of the Center for Information and Study on Clinical Research Participation, says, "It's been a real problem getting people to volunteer for clinical trials, so there's advertising on billboards, on radio, TV, and print." Source: CNN.com 6/26/08 

Biotechs Now Welcoming Patient-Advocacy Funds

Seven years ago, the chief executive of the Cystic Fibrosis Foundation gave a presentation on a new funding idea: He wanted to give millions to biotechnology companies so they could do research on early-stage projects aimed at curing cystic fibrosis. Much to his disappointment, only seven people attended the presentation. But now, after a little legwork by the foundation and an erosion in other funding for early-stage drug development, the idea has taken off. The foundation is one of numerous philanthropic and patient-advocacy disease groups that are investing millions of dollars in early-stage science that most venture-capital investors wouldn't touch. Source: San Diego Union-Tribune 6/20/08 

Diabetes: Underrated, Insidious, and Deadly

On a scale of 1 to 10, recent focus group participants consistently ranked cancer and heart disease as 9s and 10s in severity. But diabetes scored only 4s and 5s. The challenge for doctors is to convince patients that diabetes is a major health threat. For years, the message from the American Diabetes Association has been one of reassurance that the disease is treatable. Now, beginning in 2009, the association plans to reframe its message to better communicate the seriousness of the disease. Source: New York Times 7/1/08

Drug Makers Offer Aid to People "On the Edge"

Offered by major pharmaceutical companies and publicized through Web-based information clearinghouses and TV ads, prescription assistance programs (PAPs) have blossomed where good corporate citizenship meets good public relations. The result: Big Pharma gives free medication to patients with low incomes, quietly transforming the lives of those clued into PAPs' existence by knowledgeable physicians and service providers or through their own Internet research. Source: Washington Post 7/1/08

GlaxoSmithKline's Cervarix Vaccine Faces Further Delay

GlaxoSmithKline PLC does not expect to win U.S. approval for its cervical cancer vaccine Cervarix until late 2009, marking a further delay for the key product, the world's second largest drug maker said in late June. The company has responded to outstanding questions about Cervarix raised by the U.S. Food and Drug Administration, but has decided to augment its application with results from a further Phase III study, called HPV-008. Interim data from the study were filed in the original application for the vaccine in 2007. Cervarix is already approved in Europe. Source: Reuters/Yahoo! News 6/30/08

Merck Cancer Vaccine Not Cleared for Older Women

U.S. regulators have told Merck & Co. they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women. Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration (FDA) said in a letter regarding the application that it has completed its review and there are "issues" that preclude approval within the expected review time frame. Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. Source: Reuters/Yahoo! News 6/25/08

Patients to be Told About Clinical Trials

United Kingdom patients are to be given the right to be told about clinical trials in a move aimed at making the National Health Service a more attractive place for pharmaceutical and biotechnology companies to do research. The aim is also to improve patients’ access to innovative drugs and treatments. The idea of giving patients a formal right to be informed of clinical trials from which they might benefit moves beyond the current position where registers of clinical trials are available. Source: Financial Times 6/24/08

Investigation of GlaxoSmithKline's Paxil Widens

A U.S. Department of Justice investigation into whether GlaxoSmithKline PLC withheld data about the suicide risks of the antidepressant drug Paxil is widening, the Wall Street Journal has reported. The newspaper said the company confirmed that a previously disclosed Colorado-based investigation of its marketing practices also includes the U.S. attorney's office in Boston and is being coordinated by the agency in Washington. Earlier in June, U.S. Sen. Charles Grassley asked regulators to investigate whether the company withheld data about the risk of suicide when it applied for U.S. approval to market the drug. Source: Reuters/Yahoo! News 6/20/08

Study: Treating Herpes Does Not Prevent HIV

Doctors have long suspected that by treating herpes, they could also cut a person's HIV risk. But a new study published in The Lancet found the assumption may have been wrong. Researchers tracked more than 3,000 men and women infected with herpes in Africa, Peru, and the United States. Roughly half were treated with aciclovir (GlaxoSmithKline's Zovirax), an antiviral that stops herpes ulcers. After a year and a half, the scientists found that 75 people who had been receiving aciclovir were later infected with HIV, versus 64 of those who received placebo pills. Source: Associated Press/Yahoo! News 6/20/08

Sepracor Epilepsy Drug Cuts Seizures in Studies

Sepracor Inc. said late-stage studies of its experimental epilepsy treatment showed a significant reduction in partial seizures when the product was given along with other epilepsy drugs. The specialty drug maker said it plans to apply for U.S. marketing approval for the experimental drug, eslicarbazepine acetate, by late 2008 or early 2009. The results cover 1,049 patients in three Phase III studies. Compared to placebo, results showed a 35.4 percent reduction in seizure frequency over 12 weeks from an 800 mg dose, and a 38.8 percent reduction from a 1,200 mg dose. Source: Reuters/Yahoo! News 6/19/08

Competing for Biotechs' Attention

Georgia hosted biotechnology executives aboard an aircraft carrier. Nebraska plied them with Omaha Steaks. And Hawaii offered tropical drinks, island music, and hula lessons. Everywhere you looked at the world's biggest biotech show in San Diego, politicians and economic development officials were fighting for the attention of industry executives. At least a dozen governors planned to attend the Biotechnology Industry Organization show. The convention floor was crowded with more than 60 pavilions run by states, nations, and regions, ranging from Oklahoma to Spain. Source: Boston Globe 6/19/08

New Weapon to Fight Melanoma

A new study published in the New England Journal of Medicine suggests an experimental vaccine might be an effective way to treat deadly melanomas. Fred Hutchison Cancer Research Center researchers took blood from a melanoma patient who was near death and from that blood extracted a type of cell that is programmed by the body to attack cancer. Over the next three months, they grew an army of 5 billion of the cells and then injected them back into the patient. Just two months after treatment, CT and PET scans showed no sign of cancer anywhere in the patient's body. Source: ABC News 6/18/08 See also Associated Press and PRNewswire

VA Testing Drugs on War Veterans

The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found. One of the nation's premier medical ethicists said the Department of Veterans Affairs' (VA's) behavior in the antismoking study violated basic protections for humans in medical experiments. VA officials defend their use of veterans in medical studies. Source: Washington Times 6/17/08 For a statement from the VA, click here.

FDA Generic Drug Reviews Delayed, Report Finds

The U.S. Food and Drug Administration (FDA) failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand name pharmaceuticals, according to a government report released on June 13. The report, by the Department of Health and Human Services' Inspector General, also found the FDA approved or tentatively approved 4 percent of generic applications reviewed in 2006, rejecting the majority because they did not meet the agency's standards. It takes the FDA a median time of nearly 17 months to approve generic applications, according to the report. Source: Reuters/Yahoo! News 6/13/08

FDA Staff Sees Possible J&J Psoriasis Drug Risks

An experimental psoriasis drug from Johnson & Johnson is effective at relieving symptoms, but extended use may raise the risk of cancer, U.S. drug reviewers said in documents released on June 13. "Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," FDA reviewers wrote in an analysis prepared for an advisory panel. The FDA will ask the panel of outside advisers if it would be adequate to note animal data suggesting a cancer risk on the prescribing instructions for ustekinumab, or if the company should do more studies, the reviewers said. Source: Reuters/Yahoo! News 6/13/08 Update: FDA Panel Backs Proposed J&J Psoriasis Drug 6/17/08

Novartis says Glivec Misses Main Goal in Study

Novartis AG's cancer drug Glivec failed to meet its main target in a late-stage study of patients with chronic myeloid leukaemia (CML), the Swiss drugmaker said on June 13. Glivec, a once-a-day pill sold as Gleevec in the United States, is Novartis's second-biggest seller. Data from a Phase III study showed patients with newly diagnosed CML receiving a higher initial dose of Glivec showed better early responses than those taking smaller quantities. However, the difference between the two arms of the study "was not statistically significant," Novartis said. Source: Reuters/Yahoo! News 6/13/08

New-Style Bird Flu Vaccine Shows Promise

A new-style bird flu vaccine made using monkey cells instead of chicken eggs appears to be safe and effective, corporate researchers reported on June 11. The vaccine against H5N1 avian influenza, made by Baxter International, is the first bird flu vaccine to be made using cells in a lab dish. The trial of more than 250 people was a Phase I/II safety trial, but the report, published in the New England Journal of Medicine, showed the vaccine produced a strong immune response in people who received two doses. At least 16 companies are working on vaccines against H5N1. Source: Reuters/Yahoo! News 6/11/08

Spammers are Making Real Money on Fake Drugs

Some of the world's most prolific spammers have found that the most profit and growth potential lies in actually shipping the fake Viagra and other products they're hawking, according to a study released June 11 by a top security researcher. The study links Storm, a piece of malicious software known as a Trojan horse that turns ordinary PCs into spam-spewing robots, to a Russian drug maker called GlavMed, which uses factories in India and China to churn out knockoffs of Viagra and other popular drugs. Most of the Storm-generated spam touts drugs from such websites as MyCanadianPharmacy.com. Source: Los Angeles Times 6/11/08

Editorial: Hidden Drug Payments at Harvard

Three prominent psychiatrists at the Harvard Medical School and its affiliated Massachusetts General Hospital have been caught vastly underreporting their income from drug companies whose fortunes could be affected by their studies and their promotional efforts on behalf of aggressive drug treatments. Their failure to divulge their conflicts is striking proof that today’s requirements for reporting payments from industry—essentially an honor system in which researchers are supposed to reveal their outside income to their institutions—needs to be strengthened. Source: New York Times 6/10/08

Experts: Experimental Medicines an Option for Kennedy

Sen. Edward M. Kennedy is back home from brain cancer surgery with something he didn't have before: lots of treatment options. Because his tumor was operable, the 76-year-old senator is a candidate for the most promising treatments—traditional and experimental—being used against his dire disease. Six weeks of radiation and chemotherapy with Temodar are standard, but the tumor nearly always comes back. "It would be very reasonable" to add an experimental treatment right away, said the American Cancer Society's top doctor, Otis Brawley. Source: Associated Press/Yahoo! News 6/9/08

New Approach Promising Against Multiple Sclerosis

Treatment with an immune-suppressing drug may help people with the incurable disease multiple sclerosis (MS), researchers said on June 9. Their small study showed that treatment with high doses of cyclophosphamide, a generic cancer drug that has been around for half a century, cut the level of disability in MS patients, improved their physical functioning, and reduced the number of brain lesions related to the condition. Nine patients were tracked for two years after getting the drug. Five of them had no signs of disease activity, and the other four showed dramatic improvement. Source: Reuters/Yahoo! News 6/9/08 See also EurekAlert!

Cancer Drug Velcade Might Work in Lupus

Velcade, a drug used to treat cancer, might also work against the chronic autoimmune disease lupus, German researchers said on June 8. Velcade was developed by Millennium Pharmaceuticals, a U.S. biotech company that was bought two months ago by Takeda Pharmaceutical Co Ltd for $8.8 billion in the biggest overseas acquisition by a Japanese drugmaker. The injected medicine is currently given to patients with multiple myeloma, a cancer of the white blood cells. But tests on mice suggest it may also fight systemic lupus erythematosus, the research team reported in the journal Nature Medicine. Source: Reuters/Yahoo! News 6/8/08

Most Medical Schools Fail to Limit Gifts, Payments from Pharmaceutical Industry

Most U.S. medical schools do not adequately limit gifts and payments from pharmaceutical companies to physicians and students, according to a report released on June 3 by the American Medical Student Association. For the report, two evaluators issued letter grades on the conflict-of-interest policies of 150 medical schools. Only seven schools—including Mount Sinai School of Medicine, University of Pittsburgh Medical Center, and three University of California medical schools—received grades of A. Source: Kaiser Daily Health Policy Report 6/3/08

Celebrex Shows Promise in Lung Cancer Prevention

A high dose of Pfizer's arthritis drug Celebrex showed early signs that it may help prevent lung cancer in heavy smokers, researchers said on June 1. A six-month study of 212 smokers found a reduction in a specific type of precancerous change in lung cells in people who took a high dose of Celebrex compared with those who took a placebo. None of the study participants had any heart-related problems such as those with Merck & Co. Inc.'s withdrawn arthritis drug Vioxx. But the finding is very early and would need to be confirmed in longer, larger studies. Source: Reuters/Yahoo! News 6/1/08

Bone Drug Helped Stave Off Breast Cancer

A drug used to strengthen the bones of women with breast cancer helped cut the risk of the cancer returning by 36 percent, researchers said on May 31. Zometa, sold by Novartis AG, helped women with early-stage breast cancer who were already taking hormone therapy to reduce their cancer risk. The finding comes from the first large-scale study to show a drug in the class known as bisphosphonates can reduce the risk that cancer will come back. The study involved 1,803 premenopausal women who were taking a synthetic hormone to shut down their ovaries. Source: Reuters/Yahoo! News 6/1/08

FDA Panel Favors GlaxoSmithKline, Ligand Blood Drug

Advisers to the Food and Drug Administration (FDA) said on May 30 that a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside advisers voted unanimously in favor of Promacta at a meeting held in Chicago. The drug is designed to treat an immune system disorder that causes the body to destroy its own platelets, which can cause excessive bleeding. Long-term studies should be available by the end of the year, according to the companies. Source: Associated Press/Yahoo! News 5/31/08

FDA Chief Writes Congress for Money

After being pummeled for weeks on Capitol Hill over the president’s budget, Food and Drug Commissioner Andrew C. von Eschenbach has written Congress that the agency needs an immediate infusion of $275 million to ensure that imported foods, drugs, and medical devices are safe. The request was made in a letter to Senator Arlen Specter (R-Pa.) that offers a detailed spending plan for such things as opening new foreign offices, increasing inspections, and constructing new databases to track drug hazards. Source: New York Times 5/14/08

Global Market Expected to Drive Cancer Drug Growth

The global market for cancer drugs will grow twice as fast as that for all other pharmaceuticals as the developing world spends more on healthcare, a new report says. China, Brazil, Russia, and other emerging countries are becoming bigger customers for pharmaceuticals as they invest more in treating and diagnosing cancer, according to a report issued May 15 by IMS Health. Cancer drug spending is expected to grow between 12 and 15 percent annually through 2012 to $75 to 80 billion. The overall drug market is expected to grow at 6.4 percent. Source: Associated Press/Yahoo! News 5/15/08

Study Likely Spells End for Antibleeding Drug

An antibleeding drug probably will stay off the market, experts say, after a study found patients getting the medication during heart surgery were much more likely to die than patients given other drugs. Bayer AG, the maker of the drug Trasylol, faces dozens of lawsuits claiming Trasylol led to excess deaths and that the company hid evidence of harm. Experts in Canada and the United States say the study appears to seal the drug's fate, given that several prior studies linked Trasylol to an elevated risk of death after surgery—and studies that didn't find a higher risk had many weaknesses. Source: Associated Press/Yahoo! News 5/15/08 See also Reuters/Yahoo! News 5/14/08

Clot-Busting Treatment Improves Bleeding Stroke Outcomes

Researchers report they have dramatically increased the survival rate for people with strokes caused by bleeding within the brain by fine-tuning the dosage and timing for administering the clot-busting drug tissue plasminogen activator. This new treatment protocol for intracerebral hemorrhage was developed through a multicenter study of 52 patients from across the United States, Canada, Great Britain, and Germany. A definitive trial to test this treatment in 500 patients is now being planned by the researchers. Source: HealthDay News/Yahoo! News 5/14/08

More Americans are Taking Prescription Medications

For the first time, it appears that more than half of all insured Americans are taking prescription medicines regularly for chronic health problems, a study shows. The most widely used drugs are those to lower high blood pressure and cholesterol. Experts say the data reflect not just worsening public health, but better medicines for chronic conditions and more aggressive treatment by doctors. In addition, there is the pharmaceutical industry's relentless advertising. Source: Associated Press/Yahoo! News 5/14/08

Disclosing Drug Makers' Payments to Doctors Gets Boost

Legislation that would require prescription drug makers to disclose payments to doctors got a boost in May when Eli Lilly and Co. broke ranks with the industry and endorsed the bill. Lawmakers gained Eli Lilly's support after they agreed to raise the payment limit requiring disclosure from $25 to $500. The lawmakers also agreed to apply the legislation to all drug and medical device makers. Previously, the proposed disclosures would have applied only to companies with more than $100 million in annual revenue. Source: Associated Press/Yahoo! News 5/13/08

FDA Study: Insulin Pumps Linked to Injuries, Deaths in Teens

Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators finds. Parents should be vigilant in watching their children's use of the pumps, researchers from the Food and Drug Administration (FDA) wrote. They didn't advise against using the devices. But they called for more study to address safety concerns in teens and even younger children who use the popular pumps. Source: Associated Press/Yahoo! News 5/5/08

Senate Approves Genetic Nondiscrimination Legislation

The Senate on April 24 voted 95-0 to approve a bill (HR 493) that would prohibit discrimination based on the results of genetic tests. The House is expected to quickly pass the bill and send it to the White House for final approval. President Bush is expected to sign it. Under the bill, employers could not make decisions about whether to hire potential employees or fire or promote employees based on the results of genetic tests. In addition, health insurers could not deny coverage to potential members or charge higher premiums to members because of genetic test results. Source: Kaiser Daily Health Policy Report 4/25/08

Editorial: If a Drug has FDA's OK, Should You be Able to Sue?

Sometimes, after a drug has been widely marketed, adverse effects start to appear. Should victims of drugs gone bad be able to sue and collect from the makers of the drug? Or should the FDA's seal of approval shield the pharmaceutical companies from litigation? Simply blocking lawsuits, by ruling that FDA approval pre-empts them, would be destructive. Short-circuiting the discovery process would let companies conceal damaging secrets and make it virtually impossible to hold them accountable or correct the lapses of the FDA. Source: USA Today 4/25/08 For an opposing view, "Let FDA Do its Job," click here.

FDA Releases Final Rule on Human Subject Protection for Certain Foreign Clinical Studies

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. For more information, click here for a downloadable PDF or here for a regular text version of the announcement. Source: Federal Register 4/28/08

Auditors: FDA Has Long Way to Go on Foreign Inspections

House members chastised the Food and Drug Administration (FDA) in April for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products. FDA Commissioner Andrew von Eschenbach told a House subcommittee that he has asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections are needed, and that the FDA needs to make greater use of independent companies or foreign regulators to certify that drug firms have good manufacturing systems. Source: Associated Press/Washington Post 4/22/08

Cancer Patients Try Unapproved Drugs in Britain

When Jill Bracey Cowley was diagnosed with bone marrow cancer eight years ago, doctors said she had two years to live. So she decided to take a gamble and try new drugs that hadn't yet been approved. Cowley, 70, credits the treatments with enabling her to live long enough to welcome six grandchildren into the world. Unlike most terminally ill cancer patients, she had the chance to try untested drugs. With the opening of a government-run network of experimental cancer clinics across the country in April, British doctors are hoping to offer millions of dying cancer patients the same chance. Source: Associated Press/Washington Post 4/17/08

FDA Looks at Link Between Medications, Depression

Federal regulators have warned that a surprising array of drugs could play a role in spurring thoughts of self-destruction. Medicines that treat epilepsy, asthma, and influenza are now under suspicion, as is one that helps smokers kick the tobacco habit. In some cases, a review of a drug's early clinical trials turned up increased rates of suicidal thinking among subjects. In others, the tip-off was an uptick of reports that patients taking a medication for some other condition developed symptoms of depression. Moving forward, the agency will require developers of many new drugs to test for psychiatric side effects. Source: Los Angeles Times 4/14/08

Breast Cancer Vaccine Works Against Deadlier Form of Disease

A breast cancer vaccine significantly reduced the risk of recurrence for patients who have a high expression of the protein HER2/neu. This type of breast cancer tends to be deadlier than other forms of the disease. In this group, the vaccine reduced mortality by 50 percent. Even better, the vaccine lowered mortality by 100 percent in women with breast cancer and low or intermediate expression of HER2/neu. Currently, these women have no therapies other than conventional cancer treatments such as surgery and chemo. The biotech firm Apthera has licensed the NeuVax vaccine and is currently planning Phase III clinical trials. Source: Washington Post/HealthDay News 4/13/08

Drug Companies to Reveal Grant Practices

For years, the nation's largest drug and medical device manufacturers have courted doctors with consulting fees, free trips to exotic locales, and sponsored educational conferences. Those financial ties don't have to be disclosed in most cases and can lead to arrangements that some say improperly influence medical care. Now, under the threat of regulation from Congress, the two industries promise to be more forthcoming about their spending. A dozen of the nation's leading drug and device makers say that they have plans or are planning to publicly disclose grants to outside groups. Source: Associated Press/PhysOrg.com 4/11/08

Pfizer Warns of Lung Cancer with Inhaled Insulin

Pfizer Inc and Nektar Therapeutics said in April that clinical trials of the inhaled insulin Exubera found increased cases of lung cancer, leading Nektar to end product marketing talks with potential partners. Over the course of the clinical trials, six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One case was also found after Exubera reached the market. All patients who developed lung cancer had a prior history of cigarette smoking, and Pfizer said that there were too few cases to determine whether the development is related to Exubera use. Source: Reuters 4/9/08 See also Los Angeles Times

FDA says GlaxoSmithKline Failed to Report Avandia Data

GlaxoSmithKline Plc failed to report all of the required postapproval data on its diabetes drug Avandia to U.S. regulators, the Food and Drug Administration (FDA) said in a warning to the company released in April. A strong warning about heart attack risk was added to the drug in November, and the company said the FDA had received all the information before that decision was made. In a letter to GlaxoSmithKline’s chief executive, the FDA said an inspection from August through November 2007 found GlaxoSmithKline did not list multiple postapproval studies as required in various reports dating back to 2001. Source: Reuters 4/8/08

Antigenics Wins Russian Approval of Cancer Vaccine

Russian regulators have approved Oncophage, the world's first cancer vaccine, even though it failed a late-stage clinical trial. It is the first time the Russian government has approved a drug that was not first cleared in its country of origin. Antigenics plans to file for approval of the vaccine in Europe by the end of the year, based on a relatively new set of guidelines in that jurisdiction. European regulators can now approve drugs on a conditional basis, meaning companies can market their products while simultaneously conducting additional follow-up of patients or further clinical studies. Source: Reuters 4/8/08

Glaxo Wins FDA Clearance for Rotavirus Vaccine

A second oral vaccine to prevent a leading cause of severe diarrhea in infants won approval from U.S. health officials in April. The GlaxoSmithKline Plc vaccine Rotarix fights rotavirus infection, which causes about 55,000 hospitalizations in U.S. children each year and kills more than 600,000 children worldwide, mostly in developing countries. Rotarix already is approved in more than 100 other countries throughout the world. The vaccine competes with Merck & Co Inc.'s RotaTeq. In studies of more than 24,000 infants, Rotarix prevented severe and mild cases of rotavirus-caused diarrhea and vomiting during the first two years of life. Source: Reuters 4/4/08

Blood Pressure Drugs Lower Heart Risk

Two recent studies offering good news to people with high blood pressure were stopped early so the surprising benefits could be made known. One study tested a daily pill combining a diuretic and the ACE inhibitor benazepril versus a daily pill (Novartis’ Lotrel) containing benazepril and a calcium channel blocker, amlodipine, in 11,462 people in the United States and Nordic countries. The Lotrel combo proved better. A second study of 3,845 people in Europe, China, and elsewhere found dramatic benefits for treating people in their 80s, an age when blood pressure drugs were not known to be safe or effective. Source: Associated Press/Washington Post 4/1/08

Congress: Vytorin Makers Held Bad News

A congressional committee investigating whether the makers of cholesterol drug Vytorin withheld data that would hurt sales released new evidence supporting such suspicions in March. The Senate Finance Committee said even the researcher who led a crucial study of the drug accused Vytorin makers Merck & Co. and partner Schering-Plough Corp. of withholding negative results to boost sales. A letter from the committee's ranking Republican states that delaying the results affected medical decisions and put financial burdens on patients and the federal government, which has paid hundreds of millions of dollars for Vytorin since the study ended. Source: Associated Press 3/31/08

Doctors Wary After Cholesterol Drug Flop

Leading doctors urged a return to tried-and-true treatments for high cholesterol after hearing in March of a failed trial of Vytorin. Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors. The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two congressional panels launched probes into why it took drug makers nearly two years to release the study’s full results. Source: Associated Press/Washington Post 3/30/08 See also New York Times and  Los Angeles Times

FDA Probes Suicide Risk in Merck's Singulair

U.S. health regulators are probing a possible connection between Merck & Co Inc.'s blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration (FDA) said in March. The FDA said it is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking, and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing, and other allergy symptoms, as well as asthma. No definite link to the drug has been established, and the agency did not say how many postmarketing reports it had received. Source: Reuters 3/27/08 See also Associated Press/Washington Post

Tobacco Cash in Lung Study Stirs Flap

Two medical journals that published studies by Weill Cornell Medical College researchers in 2006 are looking into tobacco cash and other financial ties that weren't revealed. The studies reported benefits from lung scans, which the Cornell team has long touted. Dozens of groups, including the American Cancer Society, have given Cornell money to see if routinely screening smokers with CT scans can spot the lung cancer in time to prevent deaths. Many were stunned to learn that a foundation listed as a sponsor of the study actually got $3.6 million from a parent company of a cigarette maker. Source: Associated Press/PhysOrg.com 3/26/08

FDA to Seek More Safety Data on Stents

The FDA in March laid out new guidelines for the testing of drug-coated stents, more than two years after safety concerns curtailed use of the devices. The proposed guidelines posted to FDA's website recommend device makers conduct large, analytic studies of their stents both before and after they are submitted to FDA. In its most rigorous recommendation, FDA said companies should be prepared to track patients for up to five years after their stents are approved to monitor blood clots, heart attacks, and other potentially fatal events. Such long-term studies can cost companies millions of dollars. Source: Associated Press/Newsvine.com 3/26/08 See also the FDA announcement

AIDS Vaccine Testing at Crossroads

Leaders of the federal government's effort to develop an AIDS vaccine said in March that more of their budget needs to be spent on basic lab research and less on testing the current crop of vaccines, none of which has proved useful in human trials. The declaration, which is tantamount to an admission that almost no progress has been made in the search for an AIDS vaccine in the past 25 years, came after a vaccine tested in half a dozen countries failed to benefit people who received it and may have increased their chance of becoming infected with HIV. Source: Washington Post 3/25/08 See also Reuters

Patients' Data on Stolen Laptop

A government laptop computer containing sensitive medical information on 2,500 patients enrolled in a National Institutes of Health (NIH) study was stolen in February, potentially exposing seven years' worth of clinical trial data, including names, medical diagnoses, and details of the patients' heart scans. The information was not encrypted, in violation of the government's data-security policy. NIH officials made no public comment about the theft and did not send letters notifying the affected patients of the breach until March 20—almost a month later. They said they hesitated because of concerns that they would provoke undue alarm. Source: Washington Post 3/24/08 For a follow-up story, "Lawmakers Question NIH Handling of Data Loss," click here. For a related New York Times editorial on "Safeguarding Private Medical Data," click here.

Severe Lupus May Respond to Drug Combo

People with severe lupus that fails to respond to conventional treatment may be helped by a combination of two potent drugs, rituximab and cyclophosphamide, report researchers at Karolinska University Hospital in Stockholm, Sweden. Sixteen female patients who had not responded to conventional immunosuppressive therapy were given weekly infusions of rituximab for four weeks. The first and last infusion was combined with cyclophosphamide and a steroid. After six months, all but three patients showed at least a 50 percent improvement in disease severity. Furthermore, the disease went into remission in nine of the patients. Source: Reuters 3/19/08

A Daring Treatment, a Little Girl’s Survival

In the pages of a medical journal, Melanie Joy McDaniel is a study subject, listed by her patient number and tumor type. In real life, she’s a reminder that medical research can change lives and that the pioneers include patients, some of whom are babies. At only 9 months, she had already had two operations for a malignant brain tumor, and doctors could not be sure they had removed all the cancer. Doctors at the Dana-Farber Cancer Institute in Boston offered another option, an experimental treatment. The McDaniels took a gamble and a leap of faith, and signed Melanie up. Source: New York Times 3/18/08

Vietnam Military to Test Bird Flu Vaccine on Humans

Vietnam, one of the countries hit hardest by bird flu, will start a human vaccine trial in March, a military medical official said. The official said the Health Ministry had approved testing at the Military Medical Academy near Hanoi. The academy had been licensed by the Ministry of Health to conduct the trial, but it still required permission from the Ministry of Defense, the official said. A company run by the National Institute of Hygiene and Epidemiology said that it would produce 6 million doses per year for use in both humans and poultry should the tests be successful. Source: Reuters 3/18/08

Pushing for Pediatric Research

The Coalition for Pediatric Medical Research, a national group of nine pediatric research institutions, is seeking federal funding to create 20 networks for basic research and clinical trials on children’s diseases. The coalition includes Children's Hospital Boston; Cincinnati Children’s Hospital Medical Center; Children’s Hospital Los Angeles; The Children’s Hospital of Philadelphia; The University of Colorado Denver and The Children’s Hospital; St. Louis Children’s Hospital, Washington University School of Medicine; C.S. Mott Children’s Hospital, University of Michigan; Johns Hopkins Children's Center; and Children's Memorial Medical Center, Chicago. Source: Boston Globe/White Coat Notes 3/17/08

Drug Makers Stick by China

Even as medical imports from China are raising safety concerns worldwide, some Boston-area life sciences companies are expanding manufacturing operations there. Massachusetts' life sciences industry has been forging closer business relationships in China over the past few years. Governor Deval Patrick led a trade mission there in December, which included a stop at WuXi PharmaTech Co. The company boasts 20 Massachusetts customers. Other local companies have their own Chinese plants, including Covidien Ltd. and Inverness Medical Innovations Inc., which are both expanding production in China. And Genzyme Corp., the Cambridge biotech, is considering building a small plant in Beijing. Source: Boston Globe 3/14/08

FDA Panel Wants Limits on Anemia Drugs

Federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients—a recommendation that could cost the companies millions. The limits, proposed by a Food and Drug Administration (FDA) panel, were the latest blow to three blockbuster medications—Aranesp, Epogen, and Procrit—already plagued by concerns over increased risks of death and tumor growth. The cancer experts overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with incurable forms of cancer. Source: Associated Press/Washington Post 3/13/08 See also New York Times 3/14/08 and Los Angeles Times 3/14/08

Drug Said to Reduce HIV in 48-Week Patient Study

Avexa Ltd., the Australian company developing a medicine to treat drug-resistant HIV, said a 48-week study showed its experimental treatment reduced the virus to undetectable levels in more than 90 percent of patients. Avexa's drug, called apricitabine or ATC, also helped increase patients' CD4 cells, the infection-fighting cells that HIV destroys. Apricitabine is designed to fight the virus that causes AIDS in patients for whom other drugs are no longer effective. Source: Bloomberg 3/12/08

U.S. Drug Sales Grew at Slowest Rate Since 1961

Sales of prescription drugs in the United States grew by just 3.8 percent in 2007, marking the lowest growth rate since 1961, according to data compiled by IMS Health. Total U.S. prescription drug sales reached $286.5 billion last year, with slowing growth blamed on factors including patent expirations of lucrative medicines that opened the door to cheaper generic versions. Other reasons cited by IMS in its annual U.S. Pharmaceutical Market Performance Review were fewer new product approvals, safety concerns, and the leveling of year-over-year growth from the Medicare Part D program. Source: Reuters 3/12/08

Editorial: The High Cost of a Cancer Drug

The Food and Drug Administration’s (FDA's) recent approval of Avastin to treat advanced breast cancer has raised perplexing issues for women, their doctors, and the entire healthcare system. The hugely expensive drug had previously been approved to treat colorectal and lung cancers. Now the FDA has granted Avastin “accelerated approval” for use in metastatic breast cancer on the basis of a clinical trial that showed it slowed progression of the disease but did not significantly extend the lives of patients. The quandary is whether temporarily holding tumor progression at bay is worth toxic side effects. Source: New York Times 3/10/08

FDA is Favorable on Anti-Anesthesia Drug

Federal health regulators said in March that a Schering-Plough Corp. drug appears effective at helping patients recover from anesthesia, though some safety questions remain. An analysis of the injectable drug, Bridion, was posted to the FDA website in advance of an advisory panel hearing about its possible approval for marketing. FDA reviewers said Bridion appears safe in healthy adults, but that additional studies may be needed to answer questions about allergic reactions and the drug's effects on children's teeth. Source: Associated Press/Newsvine.com 3/7/08

Concerns Over Drugs Prompt Investigation of FDA Review Process

The government's watchdog agency is investigating whether the FDA's drug review process cleared two blockbuster medications without sufficient proof of their safety or effectiveness. Sen. Charles Grassley said in March that the Government Accountability Office has agreed to study a much-debated method for approving drugs used to clear GlaxoSmithKline PLC's diabetes pill Avandia and Merck & Co. Inc. and Schering-Plough's cholesterol drug Vytorin. The Iowa Republican requested the investigation after recent studies suggested the drugs may not lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors. Source: Associated Press/Chicago Tribune 3/4/08

Child Studies Make Drugs Safer, Show Laws Work, Researchers Say

Legislation encouraging testing of medications in children has resulted in better information about proper dosages and effects of drugs on the young, according to a study by current and former U.S. regulators. A review of 108 drugs tested in children found that the research produced new information on safety in 34 cases and new pediatric formulations in 12 instances, according to an article in the journal Pediatrics. Drug makers were unlikely in the past to research use of products in children because of the difficulty and expense, according to the article. Source: Bloomberg 3/3/08

FDA Needs More Inspectors, Updated Databases, According to FDA Official

FDA needs to hire more inspectors and update its database that tracks approved prescription drugs, Janet Woodcock, the agency's deputy commissioner for scientific affairs and chief medical officer, said in February. Woodcock said FDA focuses its inspections on U.S. drug manufacturers, conducting 1,200 domestic inspections annually, compared to 300 international inspections, which accounts for about 10 percent of all firms shipping prescription drugs or ingredients to the U.S. Woodcock did not say how many more inspectors would be necessary to increase safety, but she said FDA needs "enough to have a reasonable coverage of both domestic facilities and out-of-country facilities." Source: Kaiser Daily Health Policy Report 2/28/08

Drug Giants Warned: Tell the Truth on Medicines

The pharmaceutical industry came under assault in the United Kingdom from senior figures in medical research in February over its practice of withholding information to protect profits, exposing patients to drugs that could be useless or harmful. Experts criticized the stranglehold exerted by multinational companies over clinical trials, which has led to biased results, underreporting of negative findings, and selective publication driven by the market. The latest attack was triggered by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos in most patients. Source: The Independent 2/27/08

FDA Clears Avastin for Breast Cancer

A Genentech drug received federal approval on February 22 to treat breast cancer—a surprise decision that could represent a shift in standards for assessing the effectiveness of cancer medicines. Going against the recommendation of its advisory panel, the Food and Drug Administration (FDA) judged the effectiveness of Avastin based on measurements of tumor growth, not patient survival. The ruling prompted a mixed reaction, as some observers bemoaned the lowering of medical standards, but others applauded the federal government's endorsement of a drug that is already prescribed "off-label" to an estimated 9,500 patients and for whom insurance coverage is limited. Source: Associated Press/Physorg.com 2/23/08 (see also San Francisco Chronicle 2/23/08 and Reuters 2/22/08)

Justices Shield Medical Devices from Lawsuits

Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on February 20. The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky. Source: New York Times 2/21/08

HIV Treatment Becoming Profitable

It wasn't long ago that the pharmaceutical industry viewed HIV drugs as more of a public service than possible bestsellers. Unlike in the case of cancer or heart disease, where drugs for patients in richer markets can be instantly and startlingly profitable, two-thirds of people infected with HIV are in impoverished regions in Africa. But something unexpected is happening: As treatment of HIV patients in the U.S. and abroad continues to improve, it has turned into a growing profit center for the drug industry. No company is gaining more from the boom than once little-known Gilead Sciences Inc. in California. Source: Los Angeles Times 2/21/08

More Ammo Against Withdrawn Surgery Drug

Heart surgery patients were more likely to die if given the antibleeding drug Trasylol, two more studies have found. Bayer AG stopped selling the drug last fall, after a Canadian study was halted because of deaths among patients taking Trasylol. Bayer funded one of the two new studies, and had the preliminary results before a September 2006 federal hearing on the drug's safety—but did not present them. The company issued a statement this week saying both the new studies are flawed. But the spokesman for a consumer advocacy group said the studies are convincing confirmation of the drug's dangers. Source: Associated Press/FOXNews.com 2/20/08

Study: Gel Fails to Stop HIV Infection

The first anti-AIDS vaginal gel to make it through late-stage testing failed to stop HIV infection in a study of 6,000 South African women, disappointed researchers announced in February. The study was marred by low use of the gel, which could have undermined results, they said. Scientists plan more tests on a revamped gel containing an AIDS drug that they hope will work better. The gel used in the current study did prove safe, however, and researchers called that a watershed event. A female-controlled method is especially needed in poor countries where women often can't persuade men to use condoms. Source: Associated Press/Netscape News 2/18/08

FDA Reviewing Safety of Botox and Rival Product

U.S. regulators are reviewing the safety of Botox and a competitor amid reports that at least one child died following treatment for serious medical conditions. Serious reactions and hospitalizations of adults also were reported, the U.S. Food and Drug Administration (FDA) said. Symptoms were suggestive of botulism, which occurs when the botulinum toxin in the products spreads in the body and paralyzes muscles. No deaths were reported involving cosmetic use. Most of the serious cases were in children treated for limb spasms from cerebral palsy. That use is not approved in the United States, but is cleared in other countries. Source: Reuters 2/8/08

Safety of Drug Imports Questioned

With an ever-larger percentage of prescription drugs and drug ingredients coming to the U.S. market from developing nations, Congress is voicing concern over the number of inspections of those plants by the FDA. In a February 1 letter to the FDA, Sen. Charles E. Grassley (R-Iowa) said that the small number of inspections in these newer markets is putting consumers at risk. In particular, he wrote, he was concerned that the number of inspections in China—a major supplier of active drug ingredients—is small and actually dropped from 18 in 2004 to 11 in 2007. Source: Washington Post 2/7/08

Lawmakers, Administration to Craft Proposal Giving FDA Authority Over Generic Biotechnology Drugs

At a recent Senate Finance Committee hearing, Sen. Charles Schumer (D-N.Y.) told Health and Human Services Secretary Mike Leavitt that he had spoken with FDA Commissioner Andrew von Eschenbach about crafting a proposal that would give FDA the authority to regulate generic versions of biotechnology drugs. A Senate aide said that sticking points on the legislation are exclusivity periods granted to brand name biotech drug makers for new treatments, user fees charged by FDA for regulatory approval of generic biotech drugs, and interchangeability issues. Schumer's bill would grant 12 years of exclusivity to brand name drug makers for new biotech drugs. Source: Kaiser Daily Health Policy Report 2/7/08

Deaths Partially Halt Diabetes Study

The government abruptly halted aggressive treatment in a 10,000-patient study of diabetes and heart disease after a surprising number of deaths among patients whose blood sugar had been pushed to super-low levels—findings that call into question a growing movement in diabetes care. The National Institutes of Health took the rare step of halting part of the study 18 months early—citing 257 deaths among aggressively treated patients compared to 203 among diabetics given more standard care. That translates into an extra three deaths for every 1,000 participants per year, and researchers were at a loss to explain why. Source: Associated Press/InteliHealth 2/6/08

FDA Caution and “Research Drought” Cut Drug Approvals

Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drug makers. The FDA last year approved 17 new molecular entities—active ingredients that weren't marketed in the U.S. before. The FDA also approved 65 original new drug applications last year, the fewest since 1999, according to data from BioMed Tracker of Sagient Research Systems. The FDA approved 64 percent of the applications it decided last year, down from 73 percent the year before, BioMed data show. Source: USA Today 2/4/08

FDA Requiring Suicide Studies in Drug Trials

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration (FDA) is now requiring drug makers to study closely whether patients become suicidal during clinical trials. The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. The seeds for the new federal effort were planted four years ago with the discovery that antidepressants may cause some children and teenagers to become suicidal. Since then, agency officials have come to realize that multiple classes of medicines might cause dangerous psychiatric problems. Source: New York Times 1/24/08

Company’s Stock Dips After it Ends Hepatitis C Test

Human Genome Sciences' stock price plunged more than 40 percent after the company announced it would abandon higher dose tests of Albuferon, its hepatitis C drug, because an independent data monitoring committee expressed concerns about lung-related side effects. The company’s president and CEO said the recommendation isn't expected to delay a Phase III trial of Albuferon that is predicted to finish by spring 2009. The company began its first trial of the drug in March 2001 and is in the final stages of trials before it can get approval from the FDA to sell the drug commercially. Source: Washington Post 1/24/08

Drug Maker Undeterred by Doubts Over Inhalable Insulin

The Cambridge, Mass., biotech company Alkermes Inc. said it plans to continue working with partner Eli Lilly and Co. on an inhalable form of insulin for diabetes patients, even though two other drug makers recently scrapped work on competing products. In October, Pfizer Inc. shelved its Exubera inhaled insulin product, despite spending close to $3 billion developing and marketing the product. The company said too few patients preferred using the device to giving themselves insulin injections. In January, Novo Nordisk A/S of Denmark halted development of its own version of inhalable insulin, AERx, after studying Pfizer's Exubera failure. Source: Boston Globe 1/18/08

New Questions on Treating Cholesterol

For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol. But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory—and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say. Source: New York Times 1/17/08

Antidepressant Studies Unpublished

The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found. About 60 percent of people taking the drugs reported significant relief from depression in published trials, compared to roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks and the drugs outperform the placebos by a modest margin, concludes the new report in The New England Journal of Medicine. Source: New York Times 1/17/08

Dogs are Key to Revolutionary Cancer Study

Four million dogs are diagnosed with cancer every year—cancers very similar to the human versions. "Down to the microscope, they look very similar and they behave similarly," Dr. Robert Vonderheide at the Abramson Cancer Center at the University of Pennsylvania said. This translates into the most promising aspect of a revolutionary cancer vaccine study being performed on dogs for the future benefit of humans: "They also respond to treatment very similarly," Vonderheide points out. One of the greatest advantages to studying dogs is they age faster—literally, in "dog years," so scientists get results more quickly. Source: ABC News 1/16/08

Minorities Need to Apply, Medical Researchers Say

Minority doctors and patients participate in clinical trials at low rates, but the gap in crucial knowledge about drugs and their interactions on different medical populations resulting from this situation is being addressed by dedicated professionals such as ACRP member Francis Jones, president and chief executive of Indianapolis-based Innovative Clinical Concepts. What helps the two-person company stand out from other clinical trial service providers is Jones' determination to enroll more community-based physicians who serve minority and underserved patients. Jones provides new investigators with training, project management, budgeting, site monitoring, and regulatory help to ensure their success. Source: Indianapolis Star 1/15/08

Drug Has No Benefit in Trial, Makers Say

A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people a week, failed to show that the drug has any medical benefits, Merck and Schering-Plough said. The results will add to the growing concern over Zetia and Vytorin, a drug that combines Zetia with another cholesterol medicine in a single pill. While Zetia lowers cholesterol by 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes—or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems. Source: New York Times 1/14/08 (For a follow-up editorial in the January 16 Times, click here.)

Dengue Fever is Not Quite Dead

Dengue fever, a mosquito-borne disease that had long ago been eradicated in the U.S., is on the march again and beginning to make its presence felt with cases popping up in Texas, Hawaii, and Puerto Rico. Top health officials warn that a "widespread appearance" in the continental U.S. is "a real possibility." There is no vaccine against dengue, nor is there a drug that can cure it, although a race to develop both finally seems to be gathering momentum. Novartis is developing antiviral drugs to treat dengue; other drug makers and the National Institutes of Health are working on vaccines. Source: Los Angeles Times 1/14/08

FDA Approved Only 19 New Medications in 2007

The U.S. Food and Drug Administration (FDA) in 2007 approved 19 new medications, a decrease from 22 in 2006 and the lowest number since 1983, according to Ira Loss of Washington Analysis. An FDA spokesperson said that the agency has not totaled the number of new medications approved in 2007 and could not confirm the number cited by Loss. The director of the Center for the Study of Drug Development at Tufts University attributed the decrease to a shift in focus by pharmaceutical companies to the development of new uses for medications currently on the market, rather than new treatments. Source: Kaiser Daily Health Policy Report 1/10/08

Jump-Start on Slow Trek to Treatment for a Disease

Last month, the Bill & Melinda Gates Foundation donated $19 million to the Drugs for Neglected Diseases Initiative to find a new drug for African sleeping sickness. Not that $19 million will come close to doing that. Even if a miracle cure is found, it will take lab work and clinical trials that could easily cost $100 million. The gift spotlights just how tricky the search for new treatments can be when the disease is fearsome but nearly forgotten because its victims are poor and obscure. A drug started from scratch might not be ready until 2020 or later. Source: New York Times 1/8/08

Fresh Concerns About Amgen's Anemia Drugs

Anemia drugs sold by Amgen Inc. took another hit in January when government regulators said two new studies indicated that the drugs may increase the risk of death in some patients. Based on the studies, the FDA may further restrict the use of the drugs, which already carry the agency's strictest "black box" warning. Six recent studies have found that the drugs—all manufactured by Amgen and marketed by Amgen as Aranesp and Epogen and by Johnson & Johnson as Procrit—can lead to an increased risk of heart attack, stroke, heart failure, and cancer tumor growth in some patients. Source: Los Angeles Times 1/4/08

Researchers Work on Cocaine Vaccine

Two Baylor College of Medicine researchers are working on a cocaine vaccine they hope will become the first-ever medication to treat people hooked on the drug. The vaccine, currently in clinical trials, stimulates the immune system to create antibodies that bind to cocaine and prevent it from reaching the brain. To help the immune system distinguish the drug, researchers attached inactivated cocaine to the outside of inactivated cholera proteins. In response, the immune system not only makes antibodies to the combination, which is harmless, but also recognizes the potent naked drug when it is ingested. Source: Houston Chronicle/Associated Press 1/1/08

Drugs to Build Up that Mental Muscle

Forget sports doping. The next frontier is brain doping. As Major League Baseball struggles with performance-enhancing drugs, people in a range of other fields are reaching for a variety of prescription pills to enhance what counts most in modern life. Despite the potential side effects, academics, classical musicians, corporate executives, students, and others have embraced such drugs as Provigil, Ritalin, Inderal, and Aricept to clarify their minds, improve their concentration, or control their emotions. “Whatever company comes out with the first memory pill is going to put Viagra to shame,” said University of Pennsylvania bioethicist Paul Root Wolpe. Source: Los Angeles Times 12/20/07

The Hidden Downside of Generic Drugs

Although generics must have the same active ingredients as the brand-name product, they can include different inactive ingredients that can affect how well a patient absorbs and tolerates a particular medication. Formulas also vary from one generic manufacturer to the next. So someone who has success with, say, Company X’s Zoloft generic may have trouble if his or her prescription is refilled with Company Y’s version. This appears to be a situation that’s about to get worse before it gets better. In fiscal year 2007, the FDA approved a record 682 generic drug products, 30 percent more than in 2006. Source: Los Angeles Times 12/17/07

Biogen Idec is No Longer for Sale

The Cambridge, Mass., biotechnology firm in December said it has decided to remain independent, after two months of failing to receive a single offer to buy the company. The news is likely to relieve anxious employees, who were worried about what would happen in the event of a sale. The company has 4,300 workers and, unlike many smaller biotechs, it has several drugs on the market. But some analysts caution that growth is limited for its two biggest drugs, Avonex and Rituxan. The future is uncertain for its other major drug, Tysabri, as well as its pipeline of experimental drugs. Source: Boston Globe 12/13/07

Bristol-Myers to Downsize

Bristol-Myers Squibb said in December that it would cut approximately 10 percent of its work force, continuing a year of pharmaceutical industry layoffs as drug makers adapt to a more competitive environment. Besides layoffs, the company said it would sell or close half its manufacturing plants worldwide, farm out some manufacturing, and winnow its product portfolio by about 60 percent. Generic competition, a dearth of new drugs, and a more safety-conscious posture by the FDA are among factors that have led to the announcements of at least 35,000 industry layoffs during the last year, industry analysts said. Source: New York Times 12/6/07

Report Concludes FDA Science Dearth Puts Public Health at Risk

Lives are at risk because the FDA is woefully behind in the latest scientific advances and is underfunded, a panel of advisers to the agency said at a public meeting in December. Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA’s ability, the report by a subcommittee of the agency’s Science Board said. (A copy of the 60-page report, FDA Science and Mission at Risk, can be found here.) “FDA’s inability to keep up with scientific advances means that American lives are at risk,” the report said. Source: Reuters 12/3/07

Targeted Genetics Restarts Trial After Death

The FDA has allowed Targeted Genetics to restart testing its arthritis gene therapy after deciding the drug wasn’t at fault when one person died in the original clinical trial. Back in July, a Phase I/II study was halted after patient Jolee Mohr died from a fungal infection while testing the firm’s lead drug, tgAAC94. Patients who have not yet received their second dose of tgAAC94 will be given an updated consent form, which includes information about Mohr’s death, and will not be allowed to receive the treatment if they have a fever at the time of injection, as Mohr did. Source: DrugResearcher.com 11/26/07

A Gap in Knowledge About Kids, Medication

A decade after the government began trying to ensure that prescription drugs used to treat children work and are safe, doctors still have scant information to guide them when they administer many medications to kids. Perhaps two-thirds of the thousands of medications given to children remain untested on them. The alarming gap in medical knowledge is the legacy of many factors. The testing of drugs in children was shunned for decades as unnecessary and unethical; Congress and the pharmaceutical industry did not provide adequate funding; and conducting medical experiments on children is difficult. Source: Washington Post 11/23/07

Cardiologists Question Delay of Data on Two Drugs

Prescriptions for the cholesterol-lowering drugs Zetia and Vytorin are written for almost 800,000 Americans every week, at a cost this year of about $4 billion. Yet it still is not clear how well the drugs work. Nearly two years after the medicines’ makers, Merck and Schering-Plough, completed a clinical trial of the drugs, they still have not released the findings. The delay has led to a growing chorus of complaints from cardiologists. And in November, the companies responded by promising to publish a portion of the results next March—but not the entire set of data. Source: New York Times 11/21/07

South Africa “Underutilized” for Clinical Trials

While India, the Asia-Pacific, Eastern Europe, and Latin America are all gaining recognition as potential new hot spots, South Africa remains “underutilized as a clinical trial destination,” according to a prominent industry figure. South Africa’s “distant” proximity to the U.S., along with an accompanying ignorance and lack of perception about what the country has to offer in terms of clinical research, are partly to blame for this, according to Catherine Lund, vice chapter head of the South African arm of the Association of Clinical Research Professionals and founder of South Africa-based contract research organization OnQ Consulting. Source: DrugResearcher.com 11/20/07

Early Clinical Trials Lack Diversity

Early clinical trials “tend to enroll relatively healthy white males but few child