Showing posts with label trial. Show all posts
Showing posts with label trial. Show all posts

Thursday, July 11, 2013

Why The Response To A Philadelphia Abortion Doctor’s Ongoing Murder Trial Gets It All Wrong

A Philadelphia-area abortion doctor is currently on trial for murder, based on gruesome reports about the illegal techniques that he and his staff used to perform late-term abortions for desperate, low-income women. Dr. Kermit Gosnell’s high-profile case is sparking understandable outrage, as evidence has emerged that he may have taken advantage of vulnerable women, violated multiple medical codes, and performed inhumane surgeries.

According to prosecutors, Gosnell’s clinic went 17 years without an inspection — and abortion opponents are leveraging that to go after other abortion clinics that have no affiliation with Gosnell or his crimes. “Unfortunately and tragically in Pennsylvania, facilities were going uninspected for years,” Maria Gallagher, a lobbyist with the Pennsylvania Pro-Life Federation, said in reference to the ongoing trial. That’s a big reason why abortion opponents like Gallagher were able to push Pennsylvania legislators to tighten restrictions on abortion clinics in 2011, updating state law to require abortion clinics to adhere to the same standards as outpatient surgery centers. According to NPR, Gosnell’s case was “mentioned frequently” as Pennsylvania lawmakers considered, and ultimately approved, the unnecessary new restrictions.

If proven guilty, there’s no doubt that Gosnell and his staff committed horrific crimes. But the knee-jerk reaction to his murder trial — the assumption that most abortion doctors aren’t adhering to medical standards, and that the women who visit health clinics are in grave danger of receiving unsafe care — is off-base. In fact, as the right-wing pushes for tighter abortion clinic standards to make sure nothing like this ever happens again, that crusade could end up having exactly the opposite effect.

Pennsylvania’s abortion clinic restrictions fit into a larger anti-choice effort across the country that is solely intended to force abortion clinics to close their doors. In states like North Dakota, Virginia, Indiana, Mississippi, and Texas, abortion opponents are pushing legislation to force abortion clinics to adhere to unneccesary new regulations in the name of “ensuring women’s safety.” That sounds like a noble goal. But these measures — known as the Targeted Regulation of Abortion Providers, or TRAP — aren’t really about ensuring women’s safety at all. As Mississippi’s Republican governor once admitted behind closed doors at an anti-choice event, TRAP laws are about indirectly restricting women’s access to abortion by shutting down health clinics.

In Pennsylvania specifically, one Planned Parenthood affiliate was forced to spend nearly a half a million dollars to get two of its clinics into compliance with the new regulations. That involved unnecessary updates like installing hands-free sinks, replacing the floors, and updating the air-conditioning system. The affiliate’s CEO, Dayle Steinberg, explained to NPR that the state’s stricter requirements didn’t actually do anything to improve the care provided to the women at her clinics, where the complication rate is already less than one-tenth of 1 percent. “They were thinly disguised as improving patient safety, when really it was about increasing the cost for abortion providers — hoping that some of them wouldn’t be able to afford it,” Steinberg said.

In fact, it’s quite the opposite. Women’s health advocates consider TRAP measures to be some of the most dangerous threats to women’s access to safe abortion services across the country. In North Dakota, where anti-choice Republicans are advancing the most stringently anti-abortion legislation in the nation, one doctor warned lawmakers that the new TRAP law will force women into dangerous, “backroom” abortion procedures. Retired pediatrician Ted Kleiman worked at a hospital before Roe v. Wade legalized abortion in 1973, and he watched women die from botched abortions. “The thought of returning to those days is really beyond imagination,” Kleiman told his state lawmakers, urging them not to shut down the only abortion clinic left in North Dakota.

Women’s health advocates, particularly those who work at health clinics, are extremely concerned about ensuring that women receive the highest standards of reproductive care. But clinics that allow women to terminate a pregnancy in the first trimester of pregnancy — which involves taking a pill, and is not actually a surgical procedure — aren’t analogous to Gosnell’s clinic, which performed incredibly late-term, illegal abortion services. Over-regulating the clinics like Planned Parenthood’s, where the vast majority of patients are already receiving incredibly safe care, will actually limit women’s options instead of keeping them safe. That could lead more desperate women who feel like they don’t have any other options left to seek out doctors like Gosnell.


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Monday, July 1, 2013

UPDATE 2-Ziopharm cancer drug fails in trial; shares plunge 66 pct

* Company to halt drug development for soft tissue sarcoma

* Says will focus on synthetic biology drugs

(Adds CEO comment from conference call, analyst comment)

By Vrinda Manocha

March 26 (Reuters) - Ziopharm Oncology Inc will stop developing its drug to treat soft tissue sarcoma after it failed to improve patients' survival without the cancer worsening, wiping out nearly two-thirds of its market value.

The drug, palifosfamide, was being tested in a late-stage trial as a treatment for metastatic soft tissue sarcoma - a type of cancer of the bone, cartilage, fat or muscles.

"We know that based on progression-free survival, there is no way the drug will get approval anywhere in the world," Chief Executive Jonathan Lewis said.

The company will now evaluate all its palifosfamide programs and convert its late-stage study of the drug in small cell lung cancer to a mid-stage trial, he said.

Ziopharm said it would now focus on its synthetic biology program, which creates DNA-based drugs that enable controlled delivery of genes that produce proteins to treat cancer.

The palifosfamide sarcoma trial involved 447 patients with metastatic soft tissue sarcoma across 150 centers.

The patients received either palifosfamide along with doxirubicin - an approved cancer drug - or doxirubicin alone.

An independent committee recommended that the patients be followed to test the improvement in their overall survival, but the company said it does not expect to continue the follow-up.

Brinson Patrick Securities analyst Vernon Bernardino said the company's decision to stop the drug's development was "drastic" but noted that the company had "burned" a lot of money on the project.

"They obviously need to restructure expenses to meet the needs of what has the best chances of success and they believe more in the synthetic biologic program," Bernardino said.

Ziopharm is testing its lead drug in this program in two mid-stage trials for the treatment of melanoma and breast cancer.

However, Bernardino said he ascribed a very low value to the synthetic biology program and that it accounted for only 3 percent of his share-price target of $7.

The company's shares fell 66 percent to $1.76 in early trading -- their lowest in more than three years.

(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Maju Samuel)

((esha.dey@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ZIOPHARM STUDY/CANCER


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Saturday, June 8, 2013

Guilty Verdict Handed Down In Steubenville Rape Trial

Trent Mays and Ma'lik Richmond

On Sunday morning, Judge Thomas Lipps delivered a verdict in the much-anticipated Steubenville rape trial, determining the two high school football players charged with raping a young girl at a party are guilty on all three counts against them.

Trent Mays and Ma’lik Richmond, both minors, will likely be sentenced to jail time until they reach the age of 21. They will also be required to register as sex offenders.

The Steubenville trial exploded in the national media after graphic videos surfaced of the alleged assault. Nonetheless, the boys’ lawyers argued that the 16-year-old girl — although she appeared to be unconscious in the footage — had actually given her consent because she “didn’t affirmatively say no.” The prosecutor, on the other hand, argued that the victim “was substantially impaired, and they treated her like a toy.”

The case was tried before a judge rather than a jury — and divided the small town of Steubenville, OH, as some of its estimated 20,000 residents sided with the football stars. After reviewing the evidence, however, the judge called the case “profane and ugly” and sentenced the defendants to a juvenile detention facility.


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Tuesday, March 19, 2013

GSK promises to publish detailed drug trial data

* UK drugmaker paid $3 bln last year to settle fraud case

* Company criticised for keeping medicine data secret

* Will publish detailed clinical study reports

* Historical data back to 2000 will also be revealed

LONDON, Feb 5 (Reuters) - British drugmaker GlaxoSmithKline , which paid $3 billion last year to settle charges that it gave misleading information on its medicines, said on Tuesday it would publish more of its clinical research data.

When the company agreed to the fines last July, government officials called it the largest healthcare fraud case in U.S. history, involving Glaxo drugs such as the antidepressant Paxil and diabetes pill Avandia.

Other firms have also reached settlement deals and the industry has come under growing pressure from campaign groups to release all their clinical trial data.

GSK said it would publish the results of clinical study reports (CSRs) and clinical trials, showing its commitment to transparency.

The company already promised in October 2012 to make data from its clinical trials available to other researchers. This would include patient-level results that sit behind trials of approved and failed drugs.

"Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register," the company said in a statement.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the United States Food and Drug Administration and European Medicines Agency.

The drugmaker said that it would now publish CSRs for all its medicines once they are approved or discontinued from development. This would allow for the data to be first reviewed by regulators and the scientific community, it said. Patient data will be removed to ensure confidentiality.

Patrick Vallance, GSK's president of pharmaceuticals research and development, said the promises were aimed at helping "advance scientific understanding and inform medical judgment".

"Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research," he said in the statement.

In an apparent effort to put its past record straight, GSK also said it intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.

It said this would take time and resources as it would require retrieval and examination of each historic CSR to remove confidential patient information.

"Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years," it said.


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UPDATE 1-GSK promises to publish detailed drug trial data

* Drugmakers under fire for keeping medicine data secret

* New move builds on previous GSK pledge to be more open

* GSK will now publish detailed clinical study reports

* Industry critic Ben Goldacre says GSK move "excellent"

LONDON, Feb 5 (Reuters) - Britain's largest drugmaker GlaxoSmithKline is extending a promise to make more of its pharmaceutical research data public by publishing detailed clinical study reports as well as the results of all drug trials.

The decision marks a new level of openness in the drugs industry that other companies may be under pressure to follow. Drugmakers have long been criticised for keeping important information about their medicines under wraps.

Ben Goldacre, a British doctor and author of "Bad Science" and "Bad Pharma", who has led a campaign called AllTrials urging clinical study report (CSR) disclosure, said GSK's support for the initiative was "excellent and amazing".

GSK, which agreed a $3-billion U.S. settlement last year over misleading information about some of its drugs, already said in October it would make anonymised patient-level data from clinical trials available to other researchers.

"Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register," the firm said in a statement on Tuesday.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the U.S. Food and Drug Administration and European Medicines Agency.

Campaigners argue that CSRs are essential to assess the real value of medicines because brief summaries about trials, such as those published in academic journals, can be incomplete.

GSK said that from now on, it would publish CSRs for all of its medicines once they have been approved or discontinued from development. This would allow for the data to be first reviewed by regulators and the scientific community, it said. Patient information will be removed to ensure confidentiality.

Patrick Vallance, GSK's president of pharmaceuticals research and development, said the promise was aimed at helping "advance scientific understanding and inform medical judgment".

"Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research," he added.

Demands for greater transparency by the drug industry have come to a head in Britain with the AllTrials campaign, whose supporters include the group Sense About Science, the British Medical Journal and the Centre for Evidence-based Medicine.

In an apparent effort to put its past record straight, GSK also said it intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.

It said this would take time and resources as it would require retrieval and examination of each historic CSR to remove confidential patient information.

"Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years," it said.


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Sunday, March 3, 2013

Keryx shares keep climbing on drug trial results

Shares of Keryx Biopharmaceuticals Inc. extended its gains Tuesday, a day after the drug developer said its potential kidney disease drug, Zerenex, performed much better than a placebo in a late-stage clinical trial.

THE SPARK: The New York company said Monday that Zerenex showed a "highly statistically significant" change in serum phosphorus levels compared with a placebo in patients with advanced kidney failure who were on dialysis.

The drug also improved iron levels in patients, reducing the use of intravenous iron and other agents designed to treat anemia by boosting the oxygen-carrying component of the blood. The company said that should separate Zerenex from similar treatments on the market.

THE BIG PICTURE: Keryx has no products on the market, and Zerenex is its most advanced drug. The company plans to submit an application for approval of the drug to both the U.S. Food and Drug Administration and European regulators in this year's second quarter.

THE ANALYSIS: The magnitude of how much Zerenex decreases the need for the intravenous treatments was much better than expected, Stifel Nicolaus analyst Stephen Willey said in a research note. His estimate for peak, annual sales of the drug more than doubled to a range of $550 million to $600 million.

SHARE ACTION: Up 41 percent, or $2.48, to $8.54 in afternoon trading. The stock rose as high as $8.71 earlier in the session, its highest level since May 2010. It had soared 77 percent on Monday after Keryx announced the study results. The share price has more than tripled since the start of the year.


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Friday, February 15, 2013

Ampio Pharma says eye drug trial can go ahead

GREENWOOD VILLAGE, Colo. -- Biotech drugmaker Ampio Pharmaceuticals Inc. said Tuesday the Food and Drug Administration accepted its application to start testing the eye drug Optina.

Optina is designed to treat diabetic macular edema, which can cause blurred vision and blindness. Ampio said it plans to start clinical studies of the drug in the first quarter of 2013. Based on earlier FDA decisions, Optina could be approved based on the results of a single successful clinical trial.

Ampio is also studying an inflammation drug called Ampion and premature ejaculation treatments called Zertane and Zertane-ED. The company completed its initial public offering in July, and it does not have any approved drugs.

Shares of Ampio rose 12 cents, or 2.5 percent, to $5.01 in morning trading.


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Tuesday, January 1, 2013

UPDATE 1-Actelion's psoriasis drug meets main goal in trial

* Developing drug to treat chronic plaque psoriasis

* 46 pct of patients saw 75 pct improvement at week 16

* Plan to proceed to late-stage trials

(Adds details, background)

ZURICH, Dec 18 (Reuters) - Actelion, Europe's biggest biotechnology company, said its drug for patients suffering from the skin disease psoriasis met its main goal in a mid-stage clinical trial.

The Swiss company said on Tuesday 46 percent of patients suffering from moderate to severe chronic plaque psoriasis saw a 75 percent improvement in the Psoriasis Area and Severity Index (PASI) at 16 weeks when treated with a 20 milligramme dose of its drug ponesimod.

This compares with a 13.4 percent improvement in patients treated with a placebo. Patients receiving ponesimod continued to show improvement after the initial 16 weeks, Actelion added.

The results are a further boost to Actelion which has seen its future brighten over the past year since its new-generation heart and lung drug macitentan beat expectations in a late-stage trial.

"This is the first time that this mechanism has demonstrated efficacy with psoriasis patients," said Guy Braunstein, head of clinical development at Actelion.

The company said it now plans to start late-stage trials for ponesimod once the data has been fully analysed.

Actelion is banking on macitentan to replace its current main drug Tracleer, which goes off patent in 2015 and is already facing competition from U.S. rival Gilead's L e tairis.

Last week, Acetlion said the U.S. health regulator had agreed to evaluate macitentan for the treatment of patients with a potentially life-threatening lung condition.

(Reporting by Caroline Copley; Editing by Mark Potter)


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