Medical abortions are safe: study

- Less than one percent of women getting a medication-induced abortion at Planned Parenthood had a serious side effect or a failed abortion, according to a new study. Researchers found the rate of abortion-related complications sending women to the emergency room or requiring a blood transfusion, for example, was one in 625 during 2009 and 2010. "At Planned Parenthood, medical abortion is extremely safe," said reproductive health researcher James Trussell from Princeton University in New Jersey, who worked on the study. "The most common adverse outcome is just continuing pregnancy," he added. "It doesn't work 100 percent of the time." The data came from 233,805 first-trimester abortions done using the drugs mifepristone and misoprostol at 317 Planned Parenthood health centers. In one in 200 of those cases, women had an ongoing pregnancy that wasn't terminated after two attempts with medication, the researchers reported Thursday in Obstetrics & Gynecology. Eight women each year had an ectopic pregnancy - when the embryo implants outside the uterus - that was diagnosed after the attempted abortion. One died from related complications. Of the 233,805 abortions during the study period, 385 women had a serious side effect, including 238 who sought ER treatment, 135 who were admitted to the hospital, 114 who had a blood transfusion and 57 who required intravenous antibiotics. All of those women survived. "This continues to show that medical abortion is a very, very safe option for women," said Dr. Debra Stulberg, who studies disparities in reproductive health at the University of Chicago and wasn't involved in the new study. "That's really the take-home point." She told Reuters Health medical abortions are still less common than surgical ones in the U.S., but that they're becoming relatively more frequent and "women should be reassured" based on these and other data. Surgical procedures are also known to be safe, researchers noted. One study from 2010 found that about one percent of women having a surgical abortion before their 16th week of pregnancy had a complication that could require intravenous fluid, and just one in 300 had a major complication. One limitation, the study team noted, is that not all women checked back after the abortion or had follow up medical records available - so it's possible more complications could have occurred that weren't recorded. Planned Parenthood staff members were required to make three attempts to reach any patients who didn't return for follow up visits under the organization's medical standards and guidelines. "We assume that if anything had happened, that people would get back in touch with Planned Parenthood," Trussell told Reuters Health. "The reason that people often skip their follow up is, they're fine." Two of the study's authors are Planned Parenthood employees, and Trussell is a member of the National Medical Committee of Planned Parenthood Federation of America. Another author receives compensation from the U.S. distributor of mifepristone, Danco Laboratories. The medication regimen used by Planned Parenthood - and many other abortion providers - is slightly different than the U.S. Food and Drug Administration-approved drug course because it includes lower doses of mifepristone and at-home use of misoprostol. There have been attempts in some states to force providers to use the approved regimen, according to Trussell, even though so-called off-label use of the drugs is allowed. There's no evidence the FDA regimen is safer, he said - but it is more expensive. "It has nothing to do with medicine," he said. "It's just nuisance." Medical abortions done at Planned Parenthood run for about $300 to $800, according to its website. The researchers said their findings don't support laws restricting the drugs' use. "Mandating the FDA-approved regimen, without a scientific basis, does not protect patients from unsafe abortion; it only limits access to safe and effective medical abortion for women desiring a pregnancy termination," they concluded.

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U.S. food, animal groups seek lower ractopamine limits

Food safety and animal welfare groups petitioned the U.S. Food and Drug Administration on Thursday seeking limits on an animal feed additive that is the subject of concerns about human and animal health. Russia said earlier this month that it was requiring meat it imports to be tested and certified free of the feed additive ractopamine, a move jeopardizing the more than $500 million a year in exports of U.S. beef and pork to that country. U.S. trade authorities have taken a stand against Russia's sudden decision to require that meat imports be documented as free of ractopamine and have urged Russia to suspend such measures. Russia has denied that its action on meat imports was in response to the U.S. Senate including a measure to "name and shame" human rights violators as part of a bill expanding trade with Russia. Ractopamine is fed to animals to accelerate growth and make their meat leaner, but countries such as China have banned its use amid concerns the additive may be harmful to the animals and that traces of the drug could persist in meat products. In their petition to the FDA, the Center for Food Safety and the Animal Legal Defense Fund called for an immediate reduction in the allowable levels of ractopamine and asked FDA to study the long-term effect of human consumption and the impacts on animals associated with ractopamine. "FDA's approval for ractopamine relied primarily on safety studies conducted by the drug-maker, Elanco," the groups said in a statement. "A review of available evidence collected from FDA and the European Food Safety Authority calls FDA's approvals into question." The groups said that ractopamine is fed to an estimated 60 to 80 percent of U.S. pigs, and has resulted in more reports of sickened or dead pigs than any other livestock drug on the market. Ractopamine effects may include toxicity and other exposure risks, such as behavioral changes and cardiovascular, musculoskeletal, reproductive, and endocrine problems, the groups said. About 160 countries ban or restrict ractopamine, including all the nations of the European Union, China, Taiwan, and Russia, the groups said. FDA spokeswoman Shelly Burgess said the agency had extensively evaluated ractopamine before approval and "continues to monitor the safety and effectiveness of animal drugs like ractopamine" after they receive FDA approval. "Twenty-six other countries have also approved ractopamine," Burgess said. All of these countries ... have concluded that food derived from animals treated with ractopamine is safe for humans to eat.

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Enzon Pharma cuts more jobs, to stop drug development

Enzon Pharmaceuticals Inc said it will suspend all clinical development activities, days after the cancer drug developer decided to explore a possible sale. The company, in which activist investor Carl Icahn has a 13.29 percent stake, spent about $4 million last quarter on pipeline research and development and had cash, cash equivalents and marketable securities of $288.7 million as of September 30. It will also reduce its workforce from 43 employees to about 23-28, Enzon said. Last September, it laid off about half its workforce. The biotechnology company has two drugs in mid-stage trials and a number of others in early-stage studies. Enzon, whose revenue mainly comes from royalty payments, will incur about $1.4 million in charges related to the reduction in force and expects to record charges in the first quarter of 2013. Shares of Enzon, which has a market capitalization of about $200 million, closed at $4.50 on Thursday on the Nasdaq.

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Federal appeals court rules against Hobby Lobby on contraception

A federal appeals court on Thursday rejected a claim by an arts and crafts chain that wants to be exempted from a requirement to provide emergency contraceptives to employees because it violates the religious principles of its owners. The Court of Appeals in Denver ruled against family-owned Hobby Lobby's assertion that the religious beliefs of its owners should relieve them from providing the "morning after" and "week after" pills to their employees, as required under President Barack Obama's signature health care reforms. Hobby Lobby vowed to appeal to the U.S. Supreme Court. "The Green family is disappointed with this ruling," said Kyle Duncan, general counsel for the Becket Fund for Religious Liberty, which is assisting Hobby Lobby in the legal case. "The Greens will continue to make their case on appeal that this unconstitutional mandate infringes their right to earn a living while remaining true to their faith." The medications at issue are classified as emergency contraceptives by the Food and Drug Administration, but the owners of Hobby Lobby call them "abortion-inducing drugs" because they are often taken after conception. The lawsuit is among 42 legal actions that have been filed over the issue, according to the Becket Fund for Religious Liberty, a non-profit law firm in Washington, D.C. The company faces fines of up to $1.3 million daily if it disobeys the mandate, which takes effect on January 1 for Hobby Lobby, a $3 billion chain, and its smaller sister operation, Mardel, a Christian-oriented bookstore and educational supply company. Both companies are owned by the Green family of Oklahoma City, whose patriarch, David Green, is ranked 79th on Forbes Magazine's list of the 400 richest Americans, with a net worth of $4.5 billion. The family operates 514 Hobby Lobby stores in 41 states and employ 13,240 people. Inspirational Christian music is played in the stores, which are closed on Sundays. U.S. District Judge Joe Heaton of the Western District of Oklahoma ruled on November 19 that the privately-owned companies are secular, for-profit enterprises that do not possess the same religious rights as the individual members of the family.

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China probes Yum Brands' KFC over safety of chicken products

Yum Brands Inc's fast-food chain KFC was supplied with chicken in China that contained excessive amounts of antibiotics, said food safety authorities investigating allegations of tainted KFC products. The finding by the Shanghai Food and Drug Administration (SFDA) deals a blow to KFC's reputation in China, where it is facing fierce competition from the likes of Taiwanese-owned fried chicken chain Dico and Japanese-style noodle chain Ajisen (China) Holdings Ltd. Yum Brands has forecast a drop in same store China sales in the fourth quarter. Eight of the 19 batches of chicken samples Yum Brands sent to a testing laboratory in 2010 and 2011 contained overly high levels of antibiotics, the SFDA said in a statement on its Website late on Thursday. An investigation is underway to determine whether Yum Brands had taken corrective measures at that time, and the Louisville, Kentucky-based company may face harsh penalties if the probe showed laws had been violated, the SFDA said. Shares in Yum Brands have slumped 4 percent since December 18 when China's state television CCTV reported that some poultry suppliers in eastern Shandong province had fed chickens with anti-viral drugs and hormones to accelerate their growth. The SFDA is looking into the CCTV report and has not released its findings yet, but authorities in Shandong have already shut two chicken farms in eastern China, including one that supplied KFC and McDonald's Corp, the official Shanghai Daily newspaper reported on Thursday. Officials at Yum Brands in China could not be immediately reached for comment. KFC's subsidiary in China has pledged to cooperate with the authorities, while McDonald's wrote on its official microblog that its chicken and raw materials pass through independent, third-party laboratory tests. Shares in Yum Brands, which also owns Pizza Hut and Taco Bell, closed 1 percent lower at $69.49 in New York on Thursday. China has been trying to stamp out health violations that have dogged the country's food sector amid reports of fake cooking oil, tainted milk and even exploding watermelons. In 2008, milk laced with the industrial chemical melamine killed at least six children and sickened nearly 300,000.

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NJ residents go home after toxic chemicals cleared

PAULSBORO, New Jersey (Reuters) - Residents of New Jersey evacuated after a freight train derailment last week spewed toxic vinyl chloride began returning home on Friday as tests of the air came back clean, a Coast Guard official said. Exactly one week after a bridge collapsed, derailing seven of the 82 Conrail freight-train cars crossing the Mantua Creek in southern New Jersey, residents who were ordered out of more than 200 homes nearest the wreck were allowed back into their homes on Friday afternoon. Coast Guard Captain Kathy Moore said air tests in Paulsboro showed no further evidence of vinyl chloride, which had leaked from a gash in one tanker that tumbled into the waterway that feeds into the Delaware River near Philadelphia. At the time of the wreck, authorities said 12,000 gallons (45,425 liters) of vinyl chloride had escaped. Groups of residents were being led to their homes by law enforcement and air quality officials. The Coast Guard also offered in-home air quality checks to any resident seeking further assurance that their home is safe. One of those set to return home Friday was Yasmen Stafford, 19, the mother of 6-month-old twin boys who has been living in a motel for the last week. "I just want to get settled back in and get back to my regular routine," said Stafford as she waited at the Paulsboro volunteer fire department for an escort by a police officer and air quality specialist. Koren Warrington, 39, who has also been living in a nearby hotel, confessed she was a "little nervous" about returning home, fearing her home would smell of toxic chemicals. Paulsboro Mayor Jeff Hamilton said 680 people from some 204 houses had been evacuated after the train crash. He said he knew of nobody that has reported an air quality problem upon returning home. Vinyl chloride is a highly toxic and flammable industrial chemical. Exposure to it can cause respiratory problems, coughing and light-headedness, said Lawrence Ragonese, spokesman for the state Department of Environmental Protection. The failed rail-bridge is near both residential and commercial sections of the town of 6,100 people, which is also home to two oil refineries as well as chemical plants. Conrail is jointly owned by rail operators CSX Corp and Norfolk Southern Corp.

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Supreme Court to hear "pay-for-delay" drug case

(Reuters) - The Supreme Court agreed on Friday to decide whether brand-name drug companies may pay money to generic drug rivals to keep their lower-priced products off the market, a practice estimated to cost consumers and the government billions of dollars each year. The arrangements, known as "pay-for-delay" or "reverse payments," have for more than a decade vexed antitrust enforcers, including the Federal Trade Commission (FTC), which have been stung until recently by a series of court decisions allowing such practices. In a typical case, a generic rival challenges the patent of a brand-name competitor, which then pays the rival a sum of money to drop its challenge. Defenders of the practice call it a legitimate means to resolve patent litigation. The court accepted an appeal by the FTC, which had challenged annual payments of $31 million to $42 million by Solvay Pharmaceuticals Inc, now owned by Abbott Laboratories, to stop generic versions of AndroGel, a treatment for the underproduction of testosterone, until 2015. These payments went to rivals such as Watson Pharmaceuticals Inc, Paddock Laboratories Inc and Par Pharmaceutical Cos, and were intended to help Solvay preserve annual profits estimated at $125 million. The 11th U.S. Circuit Court of Appeals in Atlanta ruled against the FTC and upheld the arrangement in April. Two other circuit courts have also upheld such arrangements. But the federal appeals court struck down a similar arrangement in July involving Merck & Co Inc. The Supreme Court often steps in to resolve such splits. "This will be one of the most important business decisions that the court will have issued in quite some time," said Michael Carrier, a professor at Rutgers Law School in Camden, New Jersey. "These agreements cost consumers billions of dollars a year." 'WIN-WIN' FOR DRUGMAKERS According to the FTC, 127 reverse payment arrangements were struck between 2005 and 2011, at an annual cost to consumers of $3.5 billion. The agency calls the arrangements a "win-win" for drug companies that can share the benefits of high prices, while consumers, pharmacies and insurers miss out on generic drug prices that could be as much as 90 percent lower. And in November 2011, the nonpartisan Congressional Budget Office said a U.S. Senate bill to ban reverse payments would save the government $4.79 billion and lower U.S. spending on prescription drugs by $11 billion over a decade. (http://aging.senate.gov/publications/s27.pdf) That bill has not become law. Under the Hatch-Waxman Act, the first company to win U.S. Food and Drug Administration approval to sell a generic drug before the underlying patent expires has a 180-day exclusive right to market that product. This typically results in litigation by the brand-name rival, which can lead to reverse payment settlements. MERCK CASE In the Merck case, the 3rd U.S. Circuit Court of Appeals had struck down payments by Schering-Plough Corp, later bought by Merck, to rivals to delay generic versions of its potassium supplement K-Dur 20. Upsher-Smith Laboratories Inc was paid more than $60 million, court records show. The U.S. Department of Justice, acting on the FTC's behalf, urged that the Supreme Court accept the FTC case for review and reverse the 11th Circuit decision. It said the 3rd Circuit was correct to conclude that reverse payment agreements are presumptively anticompetitive and unlawful. Thirty-one states led by New York also urged the Supreme Court to hear the FTC appeal. "The court has an opportunity to clarify the law," said Keith Hylton, a professor at Boston University School of Law. "It's very important to the drug industry because companies have many investments tied up in these drugs and that would be put at risk if pay-for-delay agreements were overturned." The FTC case will be decided by an eight-member court. Justice Samuel Alito recused himself, without giving a reason. A decision is expected by the end of June. The case is Federal Trade Commission v. Watson Pharmaceuticals Inc et al, U.S. Supreme Court, No. 12-416.

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FDA panel opposes recommending painkiller, cites safety

WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts voted against recommending Zogenix Inc's Zohydro painkiller for FDA approval on Friday, citing concerns about the danger of addiction posed by the drug class known as opioids. But FDA officials said the regulatory agency could still approve the drug for sale in the United States by imposing restrictions to protect public safety. In an 11-2 vote, advisory committee members said the San Diego-based pharmaceutical company had met narrow FDA targets for safety and efficacy but worried that the drug known generically as hydrocodone bitartrate could become a drug of choice for people addicted to other opioid painkillers including those based on the drug oxycodone. "The primary thing has to be the public health," said Dr Judith Kramer of Duke University. "And I don't see how we can't see this as a promised repeat performance." FDA officials will consider the committee's recommendation in deciding by March 1 whether to approve Zohydro for sale in the United States for people who require a round-the-clock painkiller for an extended period of time. Dr Bob Rappaport, director of the FDA's division of anesthesia, analgesia and addiction products, said regulators must decide whether the panel's decision was based on a tangible difference between Zohydro and opioid-based medications already available in the marketplace. Otherwise, he told the panel, "you're punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that's not really something we can do." POSSIBLE SALES BOOST Wall Street analysts say FDA approval could bring Zogenix up to $500 million in annual sales from Zohydro by 2019, or more than ten times the pharmaceutical company's expected 2012 annual revenue of $45.5 million. Trading of Zogenix shares was suspended on Friday because of the FDA hearing. The stock closed at $2.36 on Thursday. Zohydro is a single-entity, extended-release product containing the narcotic painkiller hydrocodone with no other pharmaceutical ingredient such as acetaminophen, which can lead to liver damage if used too often. "Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue. However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen," the company said in a statement. "We remain confident in the measures we have proposed to support safe use of Zohydro and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population," it added. Health officials say hydrocodone, the active ingredient in Zohydro, is already the most widely abused drug in an opioid class linked to a prescription drug abuse epidemic that has ballooned over the past 20 years. Law enforcement officials say prescription drugs now pose a bigger public safety hazard than more traditional narcotics, including heroin and cocaine. An estimated 7 million Americans abuse pharmaceutical drugs. Prescription drugs account for about 75 percent of all drug-related U.S. overdose deaths, according to the U.S. Centers for Disease Control and Prevention. Three of every four deaths from pills involve opioid pain relievers including oxycodone. SHARPLY CONTRASTING TESTIMONY Before voting, the panel heard testimony from more than a dozen public witnesses, including chronic pain sufferers who see drugs like Zohyrdo as needed treatments to control their chronic discomfort and allow them to lead normal lives without endangering their health. But some speakers before the panel implored the experts not to recommend another potentially addictive opioid. "Today we have a chance to save people," said Avi Israel, father of an 18-year-old boy who suffered from Crohn's disease and committed suicide after becoming addicted to hydrocodone that was prescribed to slow his bowels. "Ask yourself this question," he added, "do we really need another narcotic pill to help anybody with pain? We can't handle what we have." Earlier on Friday, the panel conducted separate and sharply divided votes on safety and efficacy. Committee members voted 9-5 to find that the drug was not safe for treating patients with moderate to severe chronic pain, after voting 7-6 to find the treatment effective against pain. A panel member later changed her vote on efficacy from "no" to "yes," saying she had made a technical error.

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Judge rejects bid to block Washington state "stoned driving" rules

OLYMPIA, Washington (Reuters) - A judge on Friday rejected a request by a medical marijuana user to block Washington state from enforcing tougher "stoned driving" rules after it became one of the first U.S. states to legalize the recreational use of marijuana. Washington state voters last month approved marijuana legalization by a margin of 56 percent to 44 percent, making the state, along with Colorado, the first in the country to legalize recreational pot use. The new rules, which for most marijuana smokers would put them over the legal driving limit for a couple hours after taking two or three hits from a joint, took effect on Thursday. The legal challenge came from Arthur West, an Olympia-based lawyer and medical marijuana patient who said the ballot initiative's title wrongly left out any mention of the DUI provisions. He also argued that those provisions will enable police to target medical marijuana users, who typically have higher residual blood levels of THC--the active ingredient in marijuana--for car stops. "I don't think it's fair that the tens of thousands of patients in the state of Washington have to choose between whether they take their medicine or be subject to arrest for driving under the influence every time they get in their cars," he said. In rejecting West's request for a preliminary injunction, Judge Lisa Sutton noted that police have long been empowered to pull over drivers they suspect of impaired driving. "That is the same case today, after the passage of this initiative, as it was before," Sutton said. Though the hearing Friday dealt primarily with the DUI provisions, West's lawsuit also asserts that the initiative wrongly earmarks tax money raised by regulating marijuana for unrelated services such as primary health and dental care, and that state legislators improperly advocated its passage. West said he will push ahead with his case, taking it all the way to the state's supreme court if necessary. Assistant Attorney General Bruce Turcott, who defended the new marijuana law in court, said he was satisfied with the ruling. "I would have been very surprised" if the judge had ruled differently, Turcott added. Alison Holcomb, an attorney with the Washington state ACLU who led the legalization campaign, declined to comment on the case. Previously, Holcomb told Reuters that she included the DUI provisions in the initiative after an internal poll in May showed that 62 percent of 602 likely voters said a pot-impaired driving standard would make them more likely to vote for legalization

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