In the News

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 children, women, minorities, and older patients”—leading to research that “ignores biological differences that cause people of varying ages, genders, and ethnicities to react differently to therapies,” the Baltimore Sun reports. According to an FDA study of 185 drug trials that took place between 1995 and 2000, half of the participants were women, while the proportion of blacks declined from 9 percent in 1995 to 6 percent in 1999. Few other minorities participated in the trials, and the number of Hispanic participants was particularly low. Source: Kaiser Daily Health Policy Report 11/19/07

Russia’s Clinical Business Showing Signs of Recovery After Biologics Ban

Russia’s clinical trials industry appears to be making a gradual recovery from a recent setback when the government imposed an unexpected ban on biologic exports. According to a study by Russian contract research organization Synergy Research Group, the country’s Federal Agency for Health Care and Social Development issued 141 approvals to conduct new clinical trials during the third quarter of 2007. Although this figure is only 2 percent more than in the comparable 2006 quarter, it is a big step forward from the scenario in the second quarter, when Russia experienced a 13 percent decrease in new trial approvals. Source: DrugResearcher.com 11/19/07

Diabetes Drug to Warn of Risk to Heart

The U.S. government slapped a prominent, though confusing, warning on the diabetes drug Avandia in November—telling patients that it may, or may not, increase the risk of heart attacks. The FDA concluded that studies are too contradictory to determine if Avandia really is riskier than other treatments for Type 2 diabetes. Manufacturer GlaxoSmithKline PLC is to develop a pamphlet for use with each bottle, putting the warning in easier-to-understand language. Glaxo also agreed to FDA’s demand for a study directly comparing Avandia and its competitors’ heart effects. The study will begin by next November and won’t end until 2014. Source: Associated Press/ABC News 11/14/07

STEP HIV Vaccine Study to be Unblinded

Merck & Co., Inc. and the HIV Vaccine Trials Network (HVTN) in November announced that volunteers in the STEP study of Merck’s HIV vaccine (V520) would be told whether they received vaccine or placebo, and encouraged to continue to return to their study sites on a regular basis for ongoing risk reduction counseling and study-related tests. The study’s oversight committee made the decision to unblind volunteers following extensive discussion of the STEP results at a November meeting of the HVTN. On September 21, the trial sponsors announced that vaccinations in the study were discontinued because the vaccine was not effective. Source: Bio-Medicine.org 11/13/07