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Blogging the F.D.A. Panel on Avandia

Dr. Elaine Morrato, a panel member and an assistant professor at the University of Colorado, asked about worries that Actos might increase the risks of bladder cancer.

Dr. Mary H. Parks of the F.D.A. answered that animal trials had suggested there might be a cancer risk in the bladder. And she said that large trials of Actos did not dismiss that risk. But she said similar drugs in the same class have all suggested that the drugs might have a cancer risk.

Rebecca Killion, a panel member, asked whether Avandia might still be appropriate for patients with few cardiovascular risks.

Younger patients, for instance, are not nearly as susceptible to heart attacks as older ones. Her question led to a small debate between Dr. Steven Nissen, the Cleveland Clinic cardiologist who has advocated Avandia’s withdrawal, and Dr. Philip Home, who led the Avandia Record trial and has said that his research is funded by GlaxoSmithKline.

Dr. Nissen argued that no diabetic is without risk for cardiovascular disease.

“Not only are diabetics getting younger, but diabetics with coronary disease are getting younger,” Dr. Nissen said. “To say that there’s some diabetic that’s not at risk, is probably not something we can parse.

Dr. Home responded he routinely makes such decisions in his clinical practice. For instance, since both Avandia and Actos increase the risks of fracture, he would not give either drug to patients with osteoporosis, he said. “We would certainly target these drugs to certain groups of people,” Dr. Home said.

After a brief debate about whether the questions they will be asked to vote upon are appropriate, the committee’s members have moved into an hour of discussions and questions.

This is the time that we will begin to see how the committee is moving, and these sorts of discussions can sway uncertain panelists.

After only a handful of speakers, the public hearing ended.

Dr. Gerald Dal Pan, director of F.D.A.’s Office of Surveillance and Epidemiology, is now explaining to the committee what the advisers are supposed to do.

His message is a bit like the charge that a judge gives a jury before they consider a case. But the fact that Dr. Dal Pan is making this speech is interesting. Dr. Dal Pan is the leader of a group of review officials who have advocated forcefully for Avandia’s removal from the market. During the meeting, he has been sitting next to Dr. John Jenkins and Dr. Janet Woodcock, two F.D.A. officials who have defended Avandia’s continued sales.

The agency’s internal conflicts have been on stark display during this advisory committee meeting. But Dr. Dal Pan’s calm and even-handed presentation may be intended to signal that agency officials can work well together despite their differences.

Dr. Dal Pan assured the committee that their views are important to the agency.

“A transcript is made of these meetings, and we actually do go back and read them,” Dr. Dal Pan said. “We are very interested in the rationale for your vote.”

Jackie Bosch is reading a letter written by Dr. Salim Yusuf of McMaster University, who is a principal investigator of the Tide trial, the test comparing Avandia with Actos.

Public testimony is generally given directly, but this hearing has been unusual for several reasons.

In his letter, Dr. Yusuf bemoans the discussion in both the media and the medical literature about Avandia’s risks, saying that it has been based on poor science. He argued that only trials like the one he is in the midst of conducting can definitively answer questions about drug safety.

The public part of the advisory meeting has begun, and like so much about this meeting, it is unusual.

In many of these meetings, the public part of the meeting is made up of a collection of unsophisticated patients and doctors who tell poignant and personal stories about their experiences with a drug. But the first several public speakers for this meeting came with PowerPoint slides and sophisticated arguments about the underlying trials.

Dr. Christopher McCoy, a hospitalist at the Mayo Clinic in Minnesota, Minn., and a representative of the National Physicians Alliance, spoke about the effects that financial connections with drug makers can have on interpretations of studies. He was followed by Dr. Hal M. Roseman, who consults for GlaxoSmithKline, and amid a set of slides with pictures of the comedian David Letterman, offered a complicated set of slides defending Avandia’s continued sales.

Then came Diana Zuckerman, president of the National Research Center for Women and Families, whose slides emphasized Avandia’s dangers.

Many more speakers are coming.

GlaxoSmithKline’s reputation has been battered throughout this advisory committee hearing, and it took another hit a moment ago.

Dr. William Knowler, a panel member who is chief of diabetes epidemiology at the National institute of Diabetes and Digestives and Kidney Diseases, described a key analysis done by GlaxoSmithKline as “totally incorrect and deceptive.”

Dr. Dean Follman, a mathematician at the National Institute of Allergy and Infectious Diseases, agreed that the company’s analysis was incorrect.

“I don’t know if I would term it as deceptive,” Dr. Follman said. But since the company failed to explain why it conducted its analysis so poorly “I would ignore it, basically,” he said.

The Food and Drug Administration hearing on Avandia, the controversial diabetes drug, is under way. A complex set of votes is expected later today on whether to remove the drug from the market because of the risk for heart attacks.

Dr. Hertzel Gerstein, a professor at McMaster University who is in charge of an ongoing study comparing the safety of Avandia and Actos, started today’s hearing with a passionate defense of ethics of the study, which has been dubbed the “Tide trial.”

Nearly shouting into a microphone, Dr. McMaster said that experts who called the trial unethical on Tuesday were mistaken.

“In the next 20 minutes, I hope to correct the misperceptions that were repeated yesterday and to show you that TIDE is both appropriate and needed,” he said.

One presenter on Tuesday claimed that the TIDE trial is largely being conducted in the Third World because doctors in the United States are not comfortable with putting patients in the trial.

“Contrary to what was stated yesterday, this study is mainly being conducted in the developed Western world,” Dr. Gerstein said.

We’ll be updating this post throughout the hearing with the latest developments

July 14, 2010

Panel to Rule on Safety of Diabetes Drug

GAITHERSBURG, Md. — A federal advisory panel will vote Wednesday on whether Avandia, a controversial diabetes medicine, is safe enough to remain on the market.

The panel heard a raft of conflicting scientific information on Tuesday not only from Avandia’s maker, GlaxoSmithKline, but also from feuding scientists within the Food and Drug Administration. An important issue is whether information from clinical trials conducted by GlaxoSmithKline can be believed. On Tuesday, panel members heard evidence that patients in a crucial trial of Avandia who suffered heart attacks did not have their problems included in the trial’s final tally. And internal company documents made public in recent days show that the company hid from the public crucial information about Avandia’s safety woes.

Some reviewers within the F.D.A. said Tuesday that studies demonstrate conclusively that Avandia is far more dangerous to the heart than a similar medicine, Actos, made by Takeda. But other reviewers said that the trials are far more equivocal and provide little evidence that Avandia is dangerous. Scientists at GlaxoSmithKline argued that Avandia is a safe and important option in the treatment of Type 2 diabetes.

Questions from some panel members on Tuesday hinted that skepticism about GlaxoSmithKline’s trustworthiness is shared by at least some of the advisers. But with most of the scientific presentations completed on Tuesday, panel members are expected to give far greater voice to their own views on Wednesday. A series of complex votes are scheduled for the afternoon.

The subjects in the trial, for instance, are referred to as “patients,” a term that is misleading and plain wrong for anyone enrolled in a trial. Further, the story of Christopher Nelson and his wife’s desperation to become enrolled in the trial and his subsequent benefits from the experimental drug read more like something out of  TV movie than an objective, informative look at how a trial works. Providing cheap drama – complete with a cliffhanger at the end – appears to have been the purpose behind writing the article instead of providing helpful, accurate information.  The article will probably have hundreds if not thousands of cancer patients running to their computers and phones to try and get into a trial – any trial – because this article has led them to believe trials can provide a cure. Promoting that kind of false hope is not only bad journalism, it’s just plain mean to patients seeking a cure for cancer.

The study does not specify the level of attachment between researchers and industry but there are some who insist that even the slightest attachment introduces too much of a possibility of influence over results. Read the article in Reuters here. Other recent news about trials is below:

Insurers agree to cover cancer patients in clinical trials – MiamiHerald.com – Insurance companies will have to continue routine coverage for cancer patients who participate in clinical trials, under a new state agreement. … See all stories on this topic

Wall Street Journal – It is currently undergoing the final stage of clinical studies, or Phase-III trials, in India after successfully completing clinical trials for safety and … See all stories on this topic

Cytokinetics Announces Positive Data From Phase I Clinical Trial of CK-2017357 – CNNMoney.com (press release) – In Part B of this clinical trial, CK-2017357 produced statistically significant, placebo-corrected increases in the force exerted by the tibialis anterior … See all stories on this topic

Clinical Trials Update: Jan. 12, 2010 – BusinessWeek – This study will evaluate the safety and effectiveness of H-coil deep trans-cranial magnetic stimulation for people with major depressive disorder who have … See all stories on this topic

Clinical Trials Update: Jan. 14, 2010 – BusinessWeek – This study will evaluate a new investigational medication. The study involves one screening visit, two in-house stays of five days and four nights … See all stories on this topic

Clinical Trials Update: Jan. 15, 2010 – BusinessWeek – This study seeks candidates aged 18 to 80 with shingles. Those who qualify will receive study medication and related medical exams and tests at no cost. … See all stories on this topic

Clinical Trials Update: Jan. 13, 2010 – BusinessWeek – This study seeks people diagnosed with traumatic brain injury or stroke to participate in a fMRI study on brain activity. The research site is in Menlo Park … See all stories on this topic

Sangamo BioSciences Initiates 2 New Clinical Trials Of ZFP Therapeutics – RTT News

(RTTNews) – Sangamo BioSciences Inc. (SGMO: News ) announced the initiation of two new clinical trials of ZFP Therapeutics, a Phase 2b study in diabetic … See all stories on this topic

Threshold Pharmaceuticals Provides Clinical Development Update at JP Morgan … CNNMoney.com (press release) – The Company has three ongoing phase 1/2 clinical trials of TH-302. The “401 trial” is a trial of TH-302 as monotherapy in patients with advanced solid … See all stories on this topic

The issue of gently or overtly twisting subject’s arms by convincing them that trials exist as a legitimate medical treatment option is not contained at Carle. It is widespread. On pages 49-51 of Chasing Medical Miracles I wrote, “Therapeutic misconception is also a significant issue and is thoroughly built in to how trials function today.” Things don’t get much clearer than that. I only hope that now, with this story about Dr. Stratton in the New York Times today, pehaps people with the power to change this deplorable practice in research will start to listen and change things.

When she arrived at Carle, Dr. Stratton says, she was surprised to find a lax approach to a fundamental principle of clinical research — informed patient consent. Instead, she said, doctors too often promoted trial treatments as superior to standard approaches, even when there was no supporting evidence.

October 23, 2009

Research Uproar at a Cancer Clinic

By DUFF WILSON

URBANA, Ill. — Two years after becoming vice president for research at the biggest hospital in this university town, Suzanne Stratton said she had finally seen enough.

She had clashed repeatedly with a doctor who oversaw the local patients enrolled in more than 130 federally sponsored cancer studies — work that the hospital promoted in local television advertisements but that Dr. Stratton, who has a Ph.D. in molecular biology, said was often putting patients and science at risk.

In a meeting with Carle Foundation Hospital administrators late last year, Dr. Stratton demanded that they take action. She cited an outside audit that had found “major deficiencies” in 12 of 29 experiments being overseen by the doctor she had clashed with, potentially endangering patients or skewing the studies’ results. Dr. Stratton says her bosses responded by firing her, ushering her out of the hospital later that same day.

But federal officials, alerted by Dr. Stratton, have corroborated many of the shortcomings she found. They are continuing to investigate — an inquiry with implications for the nation’s cancer research effort that go far beyond the Carle Cancer Center.

In the last quarter century, among the hundreds of thousands of people around the nation who have enrolled in federally financed trials of cancer drugs and treatments, more than one-third have come through the doors of local medical centers like Carle.

Together, these nearly 400 federally designated community research sites and the network of 3,400 participating physicians amass more evidence for cancer science than at any of the giant cancer centers like Memorial Sloan Kettering in Manhattan or M.D. Andersen in Houston, part of the University of Texas.

Because the patients at community centers tend to be older, sicker, less affluent and generally more diverse than those treated at big academic medical centers, they are considered more representative of the national population. So, over the years, the community centers have played important roles in developing new treatments for breast, lung and prostate cancer.

And as far as federal administrators know, many of these clinics have sparkling records.

But federal officials have never conducted a systematic review of the community research program. And if Carle’s problems turn out to be any indication, the community centers may not always be adhering to the rigorous protocols of research medicine that the National Cancer Institute expects them to follow. That could call into question the scientific evidence that the community research program amasses.

The investigation is being conducted by the federal Office for Human Research Protections, an arm of the Department of Health and Human Services. So far, the office has issued two letters of criticism — one in June, the second in September — to the nonprofit Carle Foundation Hospital and its affiliated for-profit cancer center.

Meanwhile, the National Cancer Institute has shut down new patient enrollment in the studies at Carle, although it has allowed existing patients to continue experimental treatment there.

Dr. Lori Minasian, director of the National Cancer Institute’s community clinical oncology program, said the agency would apply any lessons from Carle’s human research violations “across the entire network” of community hospitals and doctors. “We’ll look at audits, organizational structure and research oversight,” she said in an interview.

Carle executives declined to comment for this article. But in their official responses to federal authorities — another response is due Tuesday — they say they have made changes, including retraining the principal investigator and other doctors, appointing new oversight managers, and “a top-to-bottom review” of protections for patients in clinical trials.

But they deny trying to cover up problems or that Dr. Stratton was fired for whistle-blowing. She has threatened to sue.

“I was devastated,” Dr. Stratton said recently.

“I have concerns not just about patient safety, but the integrity of the data in the trials,” she said. “My larger concern is that there may be other community hospitals doing research that, like Carle, evolved in a vacuum.”

The National Cancer Institute provides relatively limited financing for the community program. Carle, one of the bigger recipients, received about $1 million last year in federal research support, which does not go far in supporting the many trials under way at any one time. The greater value is the prestige the program bestows on the community clinics, making them regional magnets for doctors and patients alike.

The principal researcher at Carle, Dr. Kendrith M. Rowland Jr., is an oncologist who built a local reputation for offering the latest in cancer care. He once treated the wife of a bank owner who later donated $10 million to the cancer center.

Dr. Rowland, 55, has simultaneously overseen more than 130 clinical trials in more than 20 cancer types, a grant application shows, and he personally enrolled about one-quarter of the 500 patients that Carle signed up for experimental treatment in a typical year.

But Dr. Stratton, whom Carle hired in early 2007 to help oversee the cancer research effort, said Dr. Rowland was headstrong and had resisted her suggestions for improving standards.

Dr. Rowland did not respond to numerous telephone calls and e-mail queries, or to a reporter who visited his office; instead, he sent an aide to say he was too busy to talk. Carle representatives said Dr. Rowland would not comment, nor would the chief executive of the 305-bed hospital, Dr. James C. Leonard, who had fired Dr. Stratton.

Before coming to Carle, Dr. Stratton was well regarded in cancer research circles. She had more than a decade’s experience in clinical trials, including serving as the principal researcher in three national studies of prostate cancer. Dr. Stratton had also led a group that oversaw all drug and device trials for the University of Arizona Medical Center.

When she arrived at Carle, Dr. Stratton says, she was surprised to find a lax approach to a fundamental principle of clinical research — informed patient consent. Instead, she said, doctors too often promoted trial treatments as superior to standard approaches, even when there was no supporting evidence.

And she said that Carle’s institutional review board, which is supposed to monitor patient safety and doctors’ ethics, was too deferential to the researchers and failed to keep its own files.

In the audit that led to her showdown meeting with hospital administrators, there were instances of patients’ having received incorrect doses of drugs, while others were given chemotherapybefore, rather than after, the required lab tests. And one patient was enrolled in a study despite having an implanted brain device that, according to the audit, should have disqualified him for safety reasons.

“I can’t stress enough how serious things are over there as far as noncompliance goes,” she wrote in an e-mail message to the hospital chief last November, shortly before she was dismissed.

In a June 9 letter, the federal investigators said they had found evidence of Dr. Rowland’s “interference” with reporting problems to authorities; “continuing noncompliance” with federal research rules set up to protect patients and data; and “systemic problems involving lapses in continuing review of numerous Carle Clinic cancer studies.” The two reports are posted on a federal Web site.

Carle responded in a July 13 letter to a federal official, obtained by The New York Times. Carle argued that the violations were minor, that it was making improvements and that its doctors performed good research. It also said any interference by Dr. Rowland was not intentional.

Whether lapses at Carle were the result of ambitious doctors taking on more work than their local setup could handle, or shortfalls in financing and oversight, may not be known until the federal investigation concludes.

And Carle may prove an exceptional case. After all, most community programs have provided valuable research without running afoul of federal authorities.

But some experts in community medicine say that many of the local programs simply fly under the federal government’s radar. And they contend that some of those clinics lack the support staff, record-keeping systems and institutional oversight of larger centers to assure proper ethics and patient safety in experimental medicine.

“Trouble occurs when institutions dabble,” LaDale K. George, a Chicago lawyer who has advised dozens of community hospitals performing clinical research, said in an interview. “Well-run, organized, clearly designed, this is an activity that has manageable human risk and minimal compliance risk. Disorganized, decentralized — you have significant risk.”

I realize it’s popular to bash the media but this is not a bashing statement. It is a warning to anyone enrolled or considering enrolling in a trial to read all articles about trials with a healthy skepticism and to always, always, always speak to outside sources (such as your physician) not affiliated with the trial about whether you should enroll. Being vigilant in learning as much as possible about the trial is ultimately the subject’s responsibility.

Cutting-edge therapy is one reason many participate in clinical trials

Clinical trials give participants cutting-edge therapy

By Barb Berggoetz
barb.berggoetz@indystar.com

The pay is usually little, just enough to cover expenses. You may be poked, prodded or at least undergo tests or medical procedures over a period of time.

Most often when you’re involved in a clinical trial for a new drug, you don’t know if you’re getting the real thing or a placebo. Risks exist, of course, even though medical professionals seek to lessen them.

So why do people in the Indianapolis area participate in the thousands of clinical trials going on in such facilities as the Indiana University School of Medicine, Eli Lilly and Co. and hospitals?

The answers are as varied as the people who participate in them: Access to cutting-edge procedures or drugs, usually free. Desire to help advance treatment of a certain disease or condition for others. Getting personalized care. And the hope that the treatment may improve your own condition or prevent offspring from getting it.

Renee White didn’t hesitate to sign up when her rheumatologist told her about a local trial. She suffers so much from fibromyalgia, a chronic pain condition causing tender points in joints, muscles and tendons, that she sometimes doesn’t want bed sheets touching her. Other times, walking on a concrete floor seems like a dull drill is shooting up from her feet.

“If somebody can find out by what I do, what can make it better for me and other women and men who suffer from it, I want to be a part of that,” said White, 52, Indianapolis, who was diagnosed in 2002.

She tries to avoid medication as much as possible. So she was attracted to a trial that tests the physical benefits of standing on a vibrating vertical platform when exercising. The ongoing trial is led by Anthony Kaleth, associate professor of physical education at Indiana University-Purdue University Indianapolis.

He is testing whether adding a low-frequency vibration emanating from the platform when doing exercises, such as squats and lunges, reduces pain and produces greater gains in muscle strength and balance than when exercising without the platform. Participants work out for 45 minutes, twice a week, for eight weeks in their homes with a trial assistant.

“This gave me the ability to get up and do more things, a little more, in my day,” said White. “It helps for a while, but I wonder if I strained a muscle on it.”

When participating in a trial, people don’t know exactly how the medication or treatment will affect them. But researchers say procedures and any adverse effects are strictly monitored by “institutional review boards,” and patients are told of all potential risks and fill out an informed consent form.

In so-called double-blind trials, participants don’t know if they’re getting the drug or a placebo. However, some research requires that patients at least receive the “standard care,” if a placebo would put them at risk.

“The risk is you may get a less effective treatment because you’re in the wrong group or a more invasive surgery because you’re in that group,” said Dr. Anatha Shekhar, director of the Indiana Clinical and Translational Science Institute at the IU School of Medicine. “The biggest risk is you may not get the best treatment.”

While he acknowledged that trials all involve a certain degree of risk, the least amount occurs in health outcome studies where everyone gets the right medicine, but some get more advice, exercise or other benefits.

Linda Rodgers, 56, diagnosed with early onset Alzheimer’s disease about three years ago, doesn’t know if she’s getting infusions every six weeks of a placebo or of an antibody designed to attack the toxic protein in the brain that builds up in Alzheimer’s disease.

Regardless, she and her husband and caregiver, Scott, agree it’s still worth it for her to participate in the 18-month trial led by Dr. Ann M. Hake, associate professor of clinical neurology at the IU School of Medicine.

Even if she doesn’t get the drug, she’ll get access to it after the trial and before it’s on the market, said Scott Rodgers.

“Alzheimer’s is a very unforgiving disease,” he said. “Nothing now slows down the progression. Most medications now just help with the symptoms. Anyone who has this really ought to take as aggressive an approach as they can in treatment and clinical trials.”

His wife — who takes memory tests, gets scans and answers questionnaires during the trial — said she isn’t worried about potential risks and doesn’t notice any side effects. But it’s too early to tell any positive results.

Coming in for regular visits and receiving close medical attention is one advantage of participating, said Hake.

“A lot of times we catch other things that are going on with them. We get things nipped in the bud if problems arise.”

Despite the potential benefits, finding enough patients isn’t always easy. Researchers say many people don’t know about trials and how they can benefit. Hake thought the Alzheimer’s study would fill up soon, but only eight people are enrolled after a year, and more are needed.

“It’s very hard to find patients,” said Shekhar. “The biggest thing we need to do is reduce the perception that these are high-risk, experimental therapies that people can get very hurt from. The majority of the time they are extremely well-controlled with a lot of safety and observations and don’t carry the risk people normally associate with them.”

The sheer numbers of trials going on adds to the difficulty.

The IU medical school and its teaching hospitals alone have about 2,000 trials per year with 10,000 to 15,000 patients, said Shekhar.

St. Vincent Hospital, which has an active clinical research program, has 650 trials now, many for new cancer therapies, said Robert Lubitz, vice president for research.

Nationally, most research studies don’t recruit enough patients, although it’s better locally, he said. The bottom line, researchers say, is the entire health system benefits when enough people are available to test drugs and procedures.

“The more patients you enroll in a study,” said Lubitz, “the more you learn about a disease and the treatment.”

Facts about clinical trials

What is a clinical trial? Biomedical or health-related research studies in human beings that follow a predefined protocol. Interventional studies test a treatment, drug or other intervention; observational studies observe participants.

Who can participate? Guidelines are based on factors such as age, gender, type and stage of disease, previous treatment and other medical conditions. Many studies seek people with illnesses or conditions being studied; others need healthy participants.

What is informed consent? The process of learning key facts, risks, potential benefits of trials before deciding whether to participate. People accepted in studies may withdraw at any time.

What are the risks? Unpleasant, serious or even life-threatening side effects may exist in experimental treatments. It may not be effective for a participant. A trial may require more of a person’s time and attention, such as trips to the study site, hospital stays (usually with higher payments) or complex dosage requirements, than other treatments.

What are the phases of clinical trials? Phase I: Researchers test an experimental drug/treatment on a small group (20-80) for the first time to evaluate safety and identify side effects. Phase II: Experimental drug/treatment given to larger group (100-300) to see if it’s effective and further evaluate safety. Phase III: Large groups of people (1,000-3,000) get drug/treatment to confirm effectiveness, monitor side effects, compare to commonly used treatments. Phase IV: Post-marketing studies outline more information, such as drug’s risks, benefits and optimal use.

Source: www.ClinicalTrials.gov, an online service of the U.S. National Institutes of Health

]]> http://www.alexomeara.com/2009/10/media-bias-toward-trials/feed/ 0 http://www.alexomeara.com/2009/09/so-far-better-than-so-good-on-swine-flue-h1n1-clinical-trials/ http://www.alexomeara.com/2009/09/so-far-better-than-so-good-on-swine-flue-h1n1-clinical-trials/#comments Tue, 15 Sep 2009 16:06:44 +0000 Alex http://www.alexomeara.com/?p=315 Update: The FDA has approved the vaccine for human use. More on this tomorrow…

Published results of clinical trials so far indicate one dose of the swine flu vaccine being tested could be enough to inoculate the more than 159 million people in the U.S. who are expected to be at risk to contract the flu this season. That’s good news but – and this is big – these trials are being hurried along. The process as much as the vaccine is a test and the results could be surprising in unanticipated ways. I am loathe to be a downer about this (although I appear to one of the only ones who is not doing backflips over the apparent success so far of all efforts in HINI clinical trials) because the effort to test the vaccine is impressive, appropriate, and in the best interest of the public health. But, as always, stay tuned for all shoes to hit the ground.

In other news, the American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries, a topic close to my heart since my trip to Uganda to see the unfortunate exploitation of people there … and Vivus, a drug developer, said Wednesday that its weight-loss drug produced strong results in two late-stage clinical trials, a new medication to deliver oxygen to damaged tissue is moving ahead in trials, and a new drug for gonorrhea is also doing well in tests – all good news!

One Vaccine Shot Seen as Protective for Swine Flu – New York Times – by Donald G. McNeil Jr. – Defying the expectations of experts, clinical trials are showing that the new H1N1 swine flu vaccine protects with only one dose … See all stories on this topic

American Medical News examines clinical trials outsourcing – News-Medical.net – American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how … See all stories on this topic

Vivus, Racing Rivals, Says Diet Drug Did Well in Trials – New York Times – by Andrew Pollack – Vivus, a drug developer, said Wednesday that its weight-loss drug produced strong results in two late-stage clinical trials … See all stories on this topic

Hospital, TGen trials hold promise for patients – AZ Central.com – Scottsdale Healthcare’s flagship program involves cancer clinical trials held at the TGen Clinical Research Services at Scottsdale Healthcare located inside … See all stories on this topic

Dynavax trials hepatitis B vaccine – Pharmacy Europe – Data from PHAST clinical trials reportedly show a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six … See all stories on this topic

Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral … Reuters – “The move from preclinical trials to human clinical trials of ORMD-0901 marks a strategic milestone for the company. We have expanded our platform … See all stories on this topic

Oxygen Biotherapeutics earns $6M investment from Vatea Fund – Bizjournals.com – the company won clearance from regulators to begin clinical trials in Switzerland on Oxycyte, a compound that enhances the delivery of oxygen to damaged … See all stories on this topic

DOR BioPharma Announces NIH Grant Award to Support Phase 1/2 … Reuters … manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed … See all stories on this topic

Calvin B. Harley to Retire as Chief Scientific Officer of Geron – Reuters – The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers. … See all stories on this topic

Rib-X to move gonorrhoeae drug to clinical trials – Mass High Tech – by Mass High Tech staff Rib-X Pharmaceuticals Inc. will be bringing its drug treatment for gonorrhoeae to clinical trials, through an agreement with the US … See all stories on this topic

The story below is a good overview of things right now. I will keep updating events as they move forward. Let me know what you think.

latimes.com

Swine flu could hospitalize 2 million in U.S. this winter

As many as 300,000 could clog intensive care units in heavily affected regions, a new report says. But the CDC director notes that the H1N1 outbreak also could be much milder.

By Thomas H. Maugh II

Reporting from Atlanta

Nearly 2 million Americans could be hospitalized during this winter’s novel H1N1 influenza pandemic, with as many as 300,000 clogging intensive care units in heavily affected regions, according to a report released Monday by the President’s Council of Advisors on Science and Technology.

Overall, 20% to 40% of the population could develop symptoms of the strain commonly known as swine flu, and 30,000 to 90,000 could die, according to the report. During a normal flu season, the virus kills about 35,000 Americans.

The difference this year is that pandemic H1N1 is killing middle-aged adults and adolescents, whereas seasonal flu kills primarily the elderly.

The numbers confirm those previously released by the Centers for Disease Control and Prevention, said CDC director Dr. Thomas R. Frieden, but he emphasized the great unpredictability of flu outbreaks and cautioned that this winter’s could be much milder.

The figures are not a prediction but a possibility, said epidemiologist Marc Lipsitch of the Harvard School of Public Health, who helped prepare the 86-page report that is available on the White House website.

Researchers expect the high incidence of infections because the new flu is dramatically different from strains that have been circulating in recent years, so that the bulk of the population has no residual immunity.

“This isn’t the flu that we are used to,” said Kathleen Sebelius, secretary of the Department of Health and Human Services, at a news conference at the CDC headquarters in Atlanta. “We won’t know until we are in the middle of the flu season how serious the threat will be.”

The report also made several recommendations, including:

* A senior member of the White House staff should be responsible for coordination of all decision-making about the pandemic. The most likely candidate would be the president’s homeland security advisor.

* The CDC’s surveillance systems should be expanded to improve the chances of detecting new variants of the virus.

* The government should accelerate production of vaccines to have them become available in the middle of September rather than the middle of October, as currently planned. That would allow an initial immunization of 40 million of the most vulnerable people, including pregnant women, health workers and children.

To achieve that goal, vaccine manufacturers should be allowed to fill vaccine vials and prepare them for shipping while they await results from the clinical trials, a process known as “fill and finish.” The process normally takes a month, and waiting for results from clinical trials before beginning it would significantly delay distribution.

Sebelius said that manufacturers have been given such permission.

She also noted that no final decision had been made about using the vaccine. But, she said, “we are anticipating moving ahead with vaccination” if the clinical trials show that it works and do not raise any questions about safety.

Experts still think that two doses will be necessary to stimulate immunity because of the lack of previous exposure to the strain.

“By Thanksgiving, we should have a large group of people immunized,” she said.

thomas.maugh@latimes.com

Copyright © 2009, The Los Angeles Times

The clinical trials industry has grown 300 percent in the last 10-15 years. In the U.S. there are 20 million people enrolled in trials. Regulations have rained down because of greatly increased general participation by increased numbers of institutions, private companies, compensated physicians, special interest groups, and institutional review boards who are now conducting or seeking to conduct trials. The regulations are in place mostly to protect these entities against the threat of litigation; they are empty hoses. The regulatory pile on hasn’t been accompanied by more resources to enforce the new rules. The FDA is so slammed they can only physically inspect 1 percent of trials. Private companies are now conducting more than 70 percent of all clinical trials. These enormous changes have occurred at a time when government oversight – first in the Clinton administration and then under Bush – has been lax at best, nonexistent at worst.

The glue that holds all the red tape in place is an almost holistic lack of desire on behalf of subjects to call for more safety measures. In a poll asking subjects what they were most concerned about – including conflict of interest and lack of regulatory oversight – the number one concern of people enrolled in trials was whether the operating hours of clinics were convenient enough to not disrupt anyone’s schedule. When you truly examine the system of clinical trials you’ll find lots of bureaucracy but no one truly in charge of managing the system. In other words, no one is at the helm at all.

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