BioPharmaLife

Genta - Waiting For Genasense To Make Sense

noreply@blogger.com (Lenith) — Tue, 02 Dec 2008 13:54:00 +0000

Biopharmaceutical company Genta Inc. (GNTA.OB) has been waiting for too long to get FDA clearance for its controversial antisense cancer drug Genasense. On December 3, the FDA is expected to decide whether Genasense injection merits approval for Chronic Lymphocytic Leukemia.

Genasense, known generically as Oblimersen Sodium, is an antisense drug, which works by blocking a protein called Bcl-2, making cancer cells more vulnerable to death. Bcl-2 is one of the proteins produced by cancer cells that prevents cancer cells from dying. Blocking Bcl-2, therefore, may enable cancer treatments to be more effective.

In December 2003, Genta sought approval from the FDA for Genasense in the treatment of advanced melanoma, the most deadly form of skin cancer based on results from one of its Phase III clinical trials. The trial enrolled 771 patients with advanced melanoma who had not previously received chemotherapy. The patients were randomized to receive Genasense plus Dacarbazine, or Dacarbazine alone. The primary endpoint of the trial was to compare the overall survival between the two treatment arms.

According to the trial results, Bayer's Dacarbazine, which is commonly used in the treatment of advanced melanoma, when combined with Genasense delayed the median time before the disease worsened to 74 days from 49 days, reflecting a 51% improvement. Dacarbazine when combined with Genasense also resulted in an improvement in durable response rate of 6 months and a 72% increase in overall anti-tumor response rate.

However, Genasense failed to produce any improvement in overall survival rate and the FDA's Oncologic Drugs Advisory Committee declined to support the approval of the drug.

On April 30, 2004, the staff of the ODAC (Oncologic Drugs Advisory Committee) of the FDA stated in briefing materials in advance of the May 3, 2004 ODAC meeting that the Phase 3 clinical trial of Genasense failed to demonstrate a survival benefit, which was the primary trial endpoint. As a result of the announcement, the stock dropped $5.83 or 40.4% to close at $8.60 on an unusually high volume of over 30 million shares traded.

On May 3, 2004, the FDA panel voted 13-3, recommending the FDA to reject Genasense as the trials did not achieve the primary goal of prolonging lives. Following the news, Genta shares fell more than $3 per share to close at $5.11 that day.

On May 13, 2004 Genta withdrew its new drug application with the FDA for Genasense in the treatment of advanced melanoma.

The advisory committee's move dealt a blow to Genta's stock price and by the end of May 2004, the stock had fallen to $2.30, which reflected a decline of 81% since the start of 2004.

Then came yet another bad news, which sent Genta's stock price into a tailspin. Pharmaceutical giant Aventis, which had a collaboration agreement with Genta, since 2002, to develop and commercialize Genasense, bailed out of the partnership in November 2004. (Aventis merged with Sanofi to form Sanofi-Aventis in August 2004). Genta's stock price, which had already been on the wane, deteriorated further settling around $1.30, following Aventis terminating its partnership with Genta.

Sourse: Read Full Story

Pfizer Left And They Survived

noreply@blogger.com (Lenith) — Wed, 26 Nov 2008 11:05:00 +0000

So what happens after pharmaceutical giant Pfizer abruptly shutters a big research and development campus?

Hopefully, we won't ever have to find out here in southeastern Connecticut. But it's at least a little encouraging to know that there have been some promising stirrings from the ashes of the facility in Ann Arbor, Mich., which Pfizer shut down last year.

Stephen Rapundalo can see the now-empty Pfizer plant in Ann Arbor from his office window, and it's not a pretty sight, especially for Rapundalo, who is a city councilor.

”I drive by it every day and it's sad to see it empty,” he said. “There are some relatively new buildings there, and many of us were surprised when they closed it.”

And yet Rapundalo, who was a research scientist at Pfizer until he lost his job in the company's 2005 “adapting to scale” downsizing, is an example of the positive things that can happen in a post-Pfizer world.

Rapundalo is now president and chief executive officer of MichBio, a non-profit trade group dedicated to developing the biotech industry in Michigan, one he says is still growing, despite two big waves of Pfizer layoffs in recent years.

Some of the growth comes from former Pfizer employees who have either started their own companies or joined others, part of a developing cafeteria of small companies that can do drug development research work.

Some offer services, like conducting clinical trials, to the big pharmaceutical companies, including Pfizer. Others are developing their own drugs and show a nimbleness that the big players may find hard to match.

One Michigan startup by former Pfizer scientists is developing what the founders believe to be a better treatment for type 2 diabetes, one without the side effects of current drugs. They started out in a spare bedroom of someone's house, have found some big backers and have raised more than $10 million.

The company hopes to make it through a third phase of drug trials and get Food and Drug Administration approval to bring the drug to market by 2013.

Or maybe one of the big companies will buy them before then.

”Generally speaking, the large pharmaceuticals seem to be moving to a model where they are largely an end development and marketing company that will have to feed its research and development from the outside,” Rapundalo said.

Rapundalo estimates about 16 new companies were formed by ex-Pfizer employees after the 2003 layoffs in Kalamazoo, which followed Pfizer's purchase of Pharmacia. He says another 25 or so emerged after the Ann Arbor closure last year.

About a third of the people laid off last year in Ann Arbor have stayed in the area and work in the industry, he said. And he added some who went to other Pfizer facilities, in San Diego, St. Louis, England and Groton, have returned.

”We have developed a real strength here largely as the result of the downsizing of Pfizer,” he said. “The skill set has stayed.”

As for the plant in Ann Arbor, it's on the market, all 2 million square feet of it.

I'm glad things are working out in Michigan for many of those who lost their Pfizer jobs. And I hope we never get the post-Pfizer test here in Connecticut.

By David Collins

Source: TheDay.com

FDA delays J&J, Basilea antibiotic approval

noreply@blogger.com (Lenith) — Wed, 26 Nov 2008 10:41:00 +0000

* U.S. approval for MRSA treatment ceftobiprole delayed

* FDA says needs further site audits, other data

* New U.S. application planned within the year

* Basilea stock down 27 pct

ZURICH, Nov 26 (Reuters) - U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson (JNJ.N) and Basilea (BSLN.S), saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic to treat deadly superbug MRSA, is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent to 110.00 Swiss francs by 0848 GMT.

"At current it is difficult to gauge the extent of the impact on the approvability of ceftobiprole by the FDA," Piper Jaffray analyst Richard Parkes said.

A delay of six months or more seems inevitable, but the precedent of Theravance's (THRX.O:) telavancin -- an antibiotic whose approval was delayed due to what appear to be similar reasons -- is encouraging, Parkes said.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted until issues of data integrity had been resolved, the companies said.

"The FDA has indicated that they cannot approve the NDA (new drug application) for ceftobiprole at this time," J&J said in a statement. "They have asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union.

However, it has hit delays in the United States. The FDA had already issued an approvable letter for the antibiotic in March, indicating that further assessment of clinical data was needed.

A new application in the United States is planned within a year and European authorities have had no problems with the drug, Basilea Chief Executive Anthony Man told reporters.

The emergence of hospital superbugs such as MRSA, which are resistant to existing medicines, has increased the need for alternative treatments and re-focused attention on antibiotics.

"The agency has requested information on J&J's clinical quality assurance programmes and also asked for a new audit plan that also addresses deficiencies in contract research organisation monitoring," Basilea added. "We are deeply disappointed with the further delay in the review."

Source: Reuters

Regulatory Changes Afoot in India

noreply@blogger.com (Lenith) — Tue, 25 Nov 2008 13:12:00 +0000

As part of its broader examination of the clinical research process within its borders, India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS). Currently, Phase I studies by international companies are limited largely to experimental therapies deemed to have a sufficient amount of safety data approved by the U.S. Food and Drug Administration (FDA) or other regulating body in the drug’s country of origin.

Public discourse on the issue is unlikely before the end of India’s elections in March, notes Debashis Ghosh, vice president and global head of life sciences and healthcare at TCS. Prior to that, a Central Drug Authority bill is expected to be introduced in Parliament that seeks to centralize licensing authority for regulating the healthcare sector, including pharmaceuticals. The bill has separate provisions for medical devices, which are currently undifferentiated from drugs in regulations, as they are by the FDA.

The Central Drugs Standard Control Organisation (CDSCO) itself is being restructured, beginning with its recent move into larger quarters in New Delhi to accommodate a rising influx of trial-related regulatory documents, says Sherlekar. CDSCO has made no secret of the fact that it would like to fully automate operations as well as be a body under India’s Ministry of Health (MOH). At the moment, it reports to the MOH but responds to inquiries from a handful of other ministries.

Some time ago, registration of clinical research organizations (CROs) in India became mandatory, says Sherlekar. All the major international CROs operate here, as well as many small CROs both native and foreign. An official count has yet to be published.

The Indian Council of Medical Research, an agency of the MOH, has been actively working toward establishment of a mandatory clinical trials registry to improve the reliability of data generated and minimize duplication of trials, says Sherlekar. A voluntary registry was launched in mid-2007.

India’s clinical research market has been growing 20 percent annually over the last three to four years and the industry expects the trend to continue at least through 2012, says Sherlekar. The market is currently valued at over $200 million.

Growth in clinical research outsourcing has been happening “simultaneously” in terms of both CRO activity and “functional outsourcing” of specific tasks such as data management, says Ghosh. Even basic research and computational biological work is being outsourced to Indian pharmaceutical firms and drug discovery companies like Advinus Therapeutics, sister to TCS.

India’s strengths as a hub for clinical research include infrastructure and robust training in Good Clinical Practice, says Sherlekar. But due to exponential growth in this industry sector, it will be challenged to keep pace with the demand for clinical monitors and research associates. On the other hand, many institutes have popped up with curricula that “caters to the need.” Companies outsourcing clinical trial work to India have also invested a significant amount of time on education, often using the “train the trainer approach,” Ghosh adds.

Source: Bio-IT World

Oncology Services Europe launch India CRO operations with OSI

noreply@blogger.com (Lenith) — Tue, 25 Nov 2008 13:06:00 +0000

Oncology Services Europe (OSE), a full service Contract Research Organization, specialized in clinical drug development in Oncology launched its India operations with establishment of independent clinical services company Oncology Services India (OSI) in Ahmedabad, Gujarat. OSI will offer a complete clinical service range from Phase I (first-in-men) to Phase IV (PMS) trials.

With commencement of Indian operations, the basis of a new international “Oncology Specialist” within the global CRO business has been established. The new entity in India combines the best of clinical research capabilities of Europe and India.

Announcing the initiative, Chief Executive Officer of Oncology Services India (OSI), Dr. Vimal Sanghavi, said, “Oncology Services is looking to replicate the success of its European experience of multi-centric global trials in Indian subcontinent. Clinical trials have grown increasingly global, larger and more complex. Government regulations are progressively more stringent, requiring more studies with larger patient populations especially in Oncology. India is a favourable destination for conducting multinational clinical trials in the oncology segment. Availability of large number of therapy-naive patients in various cancer entities, highly qualified and experienced investigators and hospitals in India, coupled with the latest technological infrastructure, is the driving force of OSI.

The two companies complement technical strengths of each other and shall gain expertise from the synergies in technical areas of clinical research. With assignments underway and initial plans to offer services to offshore clients, apart from Indian clients, OSI is all set to establish a new benchmark for Indian clinical research industry. I am sure this will further win confidence of global research & development fraternity and attract a lot of clinical trial business in Asia Pacific region.”

Oncology Services Europe (OSE) is looking to tap the high growth potential of clinical services sector in Oncology segment of India. With proven expertise in clinical services segment and vast experience of handling assignments for leading international pharmaceutical / biotech companies, Oncology Services is offering comprehensive and diverse range of clinical services under one roof in India. Company is looking to tap lion’s share of country's $ 300-million clinical trials market is expected to grow at an annual growth rate of 15 % over the next four years. By 2011, this will bring nearly 15 % of the total global clinical trials to India and will generate annual revenue of $1 billion, according to market studies and research statistics.

Sharing his views on commencement of Indian operations, Chief Executive Officer of Oncology Services Europe (OSE), Dr. Wolfgang Beier, said, “By extending presence in India, OSE can reap definite benefits of faster recruitment for quality data and cost effective clinical services for its global clients. Clinical services are now a global opportunity for India with a strong competitive edge based on speed and quality of clinical development. Pharmaceutical / biotech companies are looking to outsource their clinical trials management to partners who know how to work within changing regional and global clinical trial regulations.

By expanding our capacity to serve the needs of both multinational and local pharmaceutical companies, we will be able to bring a higher level of project management, quality and expertise to facilitate clinical trials. OSI will have unlimited access to expertise and technology assistance of our European operations. Our experience of dealing with international clients with diversified needs in terms of clinical services will be an asset to our Indian operations.”

- End -

About Oncology Services:

Oncology Services Europe, based in Munich, Germany, is a specialized CRO in oncology clinical trials, provides technical expertise in terms of professional project management, and inter disciplinary consulting competence regarding the clinical development of anti-cancer drugs. It offers vast experience in undertaking Phase I – Phase IV including non-industrial studies. The list of esteemed clientele includes multinational pharmaceutical companies across European Union and US. Its Indian subsidiary, Oncology Services India, based in Ahmedabad, Gujarat, is afull-service Oncology CRO offering services from pre-clinical to post-marketing studies. It offers customized services of Project Management, Monitoring, Data Management, Biostatistics, EDC trials, Regulatory Consulting and Drug Development Consulting. OSI will participate in theyearly external audit procedure, which is part of the Standard Quality Management at OSE. Thus, the two companies can guarantee the client a high level of professionalism in conducting clinical trials based on an identical set of Standard Operating Procedures (SOPs) in the core business of clinical research.

Source: India PR wire

New Arena for Testing of Drugs: Real World

noreply@blogger.com (Lenith) — Tue, 25 Nov 2008 13:02:00 +0000

Sylvia Syvenky went for a routine dental appointment in early October, expecting to have two caps on her teeth replaced. But something went terribly wrong.

Click to enlarge

FILLING GAPS Sylvia Syvenky, 70, is part of a study on heart failure, an effort to determine which treatment is best for typical patients with complex symptoms.

Ian Jackson for The New York Times

“I felt like I was choking,” Mrs. Syvenky said. “I couldn’t take a breath. All sorts of gurgly sounds were coming out of me.”

She was rushed by ambulance to University Hospital near her home in Edmonton, Alberta, where doctors placed a mask on her face and forced air into her lungs. They told her she had heart failure. After her condition improved, they asked her to sign up for a study of a new drug to help with breathing.

Mrs. Syvenky is like many with heart failure who arrive at hospitals, unable to breathe. Yet she is the last person who would normally be asked to join a research study. At age 70, she was much older than typical study participants and her symptoms were too complex.

But now there is a growing movement to gather a new kind of evidence, the kind that will fill some of the biggest gaps in medical science: What treatment is best for typical patients with complex symptoms, like Mrs. Syvenky? Many are elderly with several chronic conditions and taking several unrelated medications. And what are the long-term effects of a treatment — death rates, side effects, progression of the disease?

A group of advocates, including medical researchers, medical societies and insurers, is lobbying Congress to pay for an Institute for Comparative Effectiveness Research that would assess treatments and identify gaps in evidence. When there are gaps, the institute would initiate what are being called “real world,” or “pragmatic,” clinical research trials to gather the evidence.

Some leading researchers who used to defend the status quo say they have switched.

“There has been a 90-degree turn” in thinking, said Dr. Eugene Braunwald, an eminent cardiologist at Harvard Medical School. “I personally have swung around.”

Although thousands of medical studies are completed every year, most have relatively limited goals. They often carefully select patients who have few medical problems other than the one under study, making it easier to get one clear result. They may not look at effects over the long term, assuming that if a treatment helps initially, patients will be better off.

But while such studies can help a drug acquire approval or answer a restricted research question, they can leave patients and doctors in a lurch because they may not tell how the new drug or treatment will work once it is tried in real patients with complex problems. Such limited studies, while they can have value, may no longer be enough, particularly when care has become so expensive and real evidence more crucial.

“They are at the heart of why we have trouble making decisions,” said Dr. Scott Ramsey, a professor of medicine at the University of Washington.

It is an issue that arises again and again. For example, it is one reason for the debate over the popular diabetes drug Avandia, or rosiglitazone. When the drug was tested, the main question was whether it lowered blood sugar, which it did. Then, after it was on the market, some researchers found hints of increased risks for heart attacks, the major killer in diabetes. But there was no way to know for sure from the studies that led to the drug’s approval.

At the same time, a move to conduct many more pragmatic trials would involve nothing less than a rethinking of how medical research is financed and managed.

“There’s this gulf between what questions researchers have found interesting to study and what questions industry and the N.I.H. have chosen to fund and what users of information most want to know,” said Dr. Sean Tunis, director of the Center for Medical Technology Policy, a nonprofit group that studies ways to get better medical evidence.

“One starts from the head and the other starts from the tail and they don’t meet in the middle.”

Dr. Robert Califf, a cardiology professor at Duke University School of Medicine and principal investigator in the heart failure study, cites the study Mrs. Syvenky entered as a model of what is so urgently needed in medicine.

The study, the largest ever in heart failure, is 15 times larger than any previous study of nesiritide. Unlike those that led to the drug’s approval, it is enrolling patients like those doctors see every day. Anyone showing up at one of 450 medical centers around the world, unable to breathe because of heart failure, is eligible. Participants are randomly assigned to get an infusion of nesiritide or a placebo, a saltwater infusion. And the study, comparing the treatments, asks two simple questions: Are patients still alive a month later? And were they readmitted to the hospital?

Dr. Califf knows the evidence problem all too well. He spent years working on committees that formulate medical guidelines for treating heart disease patients. And over and over again, he says, he and other committee members ran into a problem. The studies did not ask whether one treatment was better than another and they did not ask what happened over long periods in typical patients with their complicated medical problems.

“We looked at the A.C.C. and A.H.A. guidelines,” Dr. Califf said, referring to the American College of Cardiology and the American Heart Association. “Fifteen percent of the guidelines were based on good clinical evidence. And cardiology is where we have the most evidence.”

He added that he was not indicting studies that looked at a more limited group of patients and often studied a drug’s effects for a shorter time.

“You have to figure out the right dose. Is there a chance it could work?” Dr. Califf said. But something more is needed.

The Food and Drug Administration does not have a hard and fast rule about what it takes to show that a drug is effective, said Dr. Robert Temple, director for medical policy at the F.D.A.’s Center for Drug Evaluation and Research. A lot depends on what is known about the drug’s short-term effects and how well they predict long-term outcomes.

But, he added, there are practical concerns with large pragmatic trials because companies have to look at a wide range of possible effects when they test a drug. “If you do a large outcome study in 10,000 people in the same way you do short-term studies, you’ll never finish,” Dr. Temple said.

“There’s no white hat, black hat here,” said Dr. Kevin Weiss, president and chief executive of the American Board of Medical Examiners. “Pharmaceutical companies are trying to do what they are supposed to do. The F.D.A. is trying to do what it is supposed to do. But they are not fully connected to what the public needs.”

That was part of the problem with nesiritide. At first, all was well. The drug dilates blood vessels, making it easier for the heart to pump blood into the rest of the body. Patients breathed better.

The F.D.A. approved the drug in 2001 based on studies that asked about breathing in the first few hours and excluded patients with symptoms as complex as Mrs. Syvenky’s, even though she is typical of half of all people with heart failure. The patients in the original studies, mostly white men, had an average age of 60. Yet more than 800,000 Americans aged 65 and older were hospitalized for heart failure in 2006, the most recent year for which statistics are available.

In 2005, questions arose. Researchers lumped together data from several nesiritide studies. One analysis reported damage to kidney functions and the other found increased death rates. Sales plummeted.

But no single study was large enough to determine if those risks were real, and merging smaller studies in a so-called meta-analysis can be misleading.

In fact, said Dr. Adrian Hernandez, a cardiologist at Duke University, meta-analyses have been a risky business. When their conclusions were tested in subsequent studies, they have been correct just 60 percent of the time. They are good for generating hypotheses or perhaps when clinical trials are impractical. But as evidence? They are about as accurate as tossing a coin.

With fears about the drug growing, Johnson & Johnson, the drug’s maker, asked Dr. Braunwald to put together an expert panel to advise it.

The questions about nesiritide were so pressing, Dr. Braunwald’s panel concluded, that the drug should be given to only the sickest patients in a hospital setting. In the meantime, the company needed to conduct a large pragmatic trial looking at clinical outcomes in typical patients.

“The data on which the drug was approved were very sketchy,” Dr. Braunwald said in a recent interview. “And since the question had been raised by these two meta-analyses, which in themselves were controversial, the idea of a pragmatic, outcomes-based clinical trial was very natural.”

Dr. Steven Goodman, an oncologist and biostatistician at Johns Hopkins University School of Medicine, wants to insert a reality check on large pragmatic clinical trials.

“When they are first described, they sound wonderful,” he said. But, he added, there’s a rub. “You often give up the ‘why.’ ”

Pragmatic trials, he explains, are most feasible when they are as simple as possible, measuring important outcomes like hospitalizations or deaths but not things like how much medication is taken, how well a procedure is performed or how accurately an X-ray is read.

An operation, for example, may not work well in the real world because it takes more skill and training than is typically found outside a few medical centers. A pragmatic trial will show the surgery is not working but not why.

Scientists, Dr. Goodman added, do not like giving up on the why. And that leads to a question of who is going to pay for these studies. Medicare pays for medical care but does not sponsor studies. Insurance companies, said Dr. Goodman, who helps review evidence for Blue Cross Blue Shield, may be seen as having a conflict if they sponsor studies because they may have to pay for treatments that are shown to be effective.

Drug companies sometimes do pragmatic studies, said Alan Goldhammer, the vice president for regulatory affairs at Pharma, a trade group for drug companies. But usually that is when “there are issues relating to the drug and the ability to affect drug and marketplace.”

At the National Institutes of Health, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, “many of us would love to do many more of these studies.” But, she added, “we have a limited budget and there is only so much that we can do.”

The nesiritide study was a direct result of Dr. Braunwald’s panel’s recommendation. Johnson & Johnson is paying for it. But the study’s overall conduct, design and analysis are coordinated at Duke University through an academic consortium and led by an independent academic executive and steering committee.

When the study began, some heart specialists said it could never enroll enough patients. Who would agree to be randomly assigned to a placebo or a drug to ease breathing?

So far, however, recruitment is ahead of schedule, Dr. Hernandez said, which he attributes to the researchers’ enthusiasm. And, he adds, there are already more patients from North America in this study than in any acute heart failure study ever done.

Source: StarNewsOnline.com

17 lose licence to make obesity drug

noreply@blogger.com (Lenith) — Tue, 25 Nov 2008 12:55:00 +0000

India’s drug regulator has cancelled licences granted to 17 companies to produce anti-obesity drug rimonabant

New Delhi / Hyderabad: India’s drug regulator cancelled on Friday licences granted to 17 companies to produce anti-obesity drug rimonabant after Europe’s drug regulator recommended that member countries not allow the previously approved drug to be sold because it caused serious psychiatric side effects including suicidal tendencies.

The regulator had previously approved the sale of the generic version of the drug here by companies including Zydus Cadila, Sun Pharmaceutical Industries Ltd, Torrent Pharmaceuticals Ltd and Ranbaxy Laboratories Ltd.

Such approval, for drugs already patented and being sold elsewhere merely requires so-called bio-equivalence studies that seek to show that the drug’s generic version acts the same way the patented one does. The drug, created by Sanofi-Aventis SA isn’t patented in India.
Rimonabant was touted as the next blockbuster drug when it was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia.
Interestingly, the drug wasn’t approved by the US drug regulator and wasn’t launched in that country. Apart from 18 countries in the EU, Sanofi Aventis was selling the drug in 14 countries including some in Latin America.
“Europe’s drug regulatory authority—European Medicines Agency (EMEA) suspended the manufacture of the drug in the UK and the European Union and the US food and drug administration did not approve it at all due to reports of severe (psychiatric) side effects. So, we are also suspending any further manufacture of the drug in India,” said drug controller general of India (DCGI) Surinder Singh. He added that the Central Drugs Standard Control Organization (CDSCO, the name of the organization headed by Singh) would not wait for any reported adverse reaction data from within India since “the country’s pharmacovigilance system is not very strong yet”.
All state licensing authorities have also been informed of the suspension of the drug in the market and rimonabant, under any brand name, should no longer be available for purchase. “We have a communication from the (drugs) regulator asking us to stop manufacturing rimonabant. We are complying with this communication with immediate effect,” said a Sun Pharma spokesperson. The company said it hadn’t received any reports of an adverse reaction to the drug it launched in 2007.

The drug was first launched in India by Torrent Pharma as Rimoslim in May 2007. Total sales from all 17 brands of rimonabant were worth Rs13 crore in the first nine months of this year, with Zydus Cadila’s Slimona selling the most (Rs4 crore), according to data from research firm ORG IMS.

Despite all the hype, rimonabant did not catch the fancy of many doctors in the country. “I used to prescribe versions of rimonabant to my patients for obesity and metabolic syndrome. But within a few months I started receiving complaints of severe depression, suicidal tendencies, irritability, lack of concentration, headache and reduction in social interaction from many patients,” recalls Dr Vipin Mishra, senior consultant, endocrinology, at Fortis Healthcare Ltd’s Fortis Hospital. Mishra added that he stopped prescribing the drug after the initial few months because “...it wasn’t very effective”.
EMEA’s recommendation was based on post-marketing data or details of post-launch feedback from the company and consumers. On 23 October, EMEA’s committee for medicinal products for human use (CHMP) concluded that the benefits of rimonabant no longer outweighed its risks and recommended the suspension of its marketing licence.

Following this, the UK suspended sales of the drug.

“Taking into account the concerns raised by some national and regional regulatory authorities, we decided to suspend the sales of rimonabant (Acomplia) in all the 32 countries,” Sanofi-Aventis spokesperson Jean-Marc Podvin said in a telephonic conversation with Mint.
The company also suspended so-called phase III human clinical trials of the drug in several countries, including India, that would have allowed the company to apply for marketing approval for Acomplia. “All rimonabant related clinical trials, currently going on in about 50 (additional) countries, have been suspended. Further, we have stopped development related activities related to this drug,” Podvin said. He declined details of how much the company had spent on these trails in India and other markets.

Subsequently, Pfizer Inc. announced it was terminating the phase III development of a similar molecule CP-945,598. “While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” said Martin Mackay, president, Pfizer Global research and development, in a press release.

In the first nine months of the calendar year 2008, rimonabant contributed $81 million (Rs401 crore) to the $26,201 million revenue of Sanofi-Aventis. “We expect the impact of rimonabant sales suspension on company’s whole year profits to be in the range of $50 million,” Podvin said.

Source: LiveMint

Rs250 cr to make drugs regulatory process completely paperless

noreply@blogger.com (Lenith) — Mon, 24 Nov 2008 12:57:00 +0000

New Delhi: The ministry of health and family welfare will invest close to $50 million (Rs250 crore) in the Central Drugs Standard Control Organization’s (CDSCO) e-governance initiative. The initiative, the first of its kind in the world, will be developed by New York-based technology solutions providerMGRM. The application aims to enable transparency and efficiency in the working of the CDSCO.

“Details of licensing, regulation, monitoring and even inspection audits will seamlessly be available through the software,” says K.V.R. Murthy, group chairman of MGRM.

People-friendly step: Drugs controller general of India Surinder Singh says the World Health Organization has shown interest in the project. Manoj Kapparath / Mint

This will work not only for companies, who will be able to submit all applications and data online, but will also smoothen the interface between various officials of the drug controller’s office. Companies will even be able to file, track and review their patent applications online.

“Once an application is submitted online,” explained drugs controller general of India (DCGI) Surinder Singh, “the information or protocol will be split according to work category and will then go to the official assigned for that job. This means that no one person will have access to complete information except a few senior officials.”

This model of work distribution will ensure privacy and data protection since officials in the ministry or in a company will not have permission to change or download any data from the site.

In fact, according to the proposed plan, unauthorized attempt to access information will immediately send off an alert making it difficult to break into the system. The first phase of the project is expected to be completed in a year, following which CDSCO, along with MGRM, will float a national tender inviting developers to bid for the project. The project itself is expected to be up and running by 2013.

“The e-governance project will most of all benefit the general public. The way we intend to develop it, public will have access to list of medicines that are banned, approved and that can cause allergic reactions,” said Murthy.

That apart, the project will also aid companies in tracking the movement of their applications and would then be able to base their development targets based in this.

The DCGI’s e-governance initiative has received interest from the World Health Organization and Health Canada—the Canadian health regulator.

“They have approached us and have shown a lot of interest in signing an MoU (memorandum of understanding) on the same,” said Singh. What is even more comforting is that adverse drug reactions in volunteers who enrol for multiple clinical trials in quick succession at the prospect of high remuneration will not be able to do so. Finger printing software, part of the project, will interlink clinical trial softwares, allowing companies to enrol only first time volunteers.

In most developed countries, though the pharma companies can submit applications online, the processing is done through physical transactions. The e-governance initiative will make India’s regulatory process completely paperless.

Source: LiveMint.com

India's biotech sector set to thrive despite downturn

noreply@blogger.com (Lenith) — Mon, 24 Nov 2008 12:55:00 +0000

India is one of the top biotech hubs in the world and despite a slowing global economy, the sector is expected to not just survive, but thrive.

The election of Barack Obama as incoming US president looks to be a shot in the arm for the Indian pharmaceutical industry. He has promised increased spending on public health and this could benefit India, one of the largest generic drug suppliers in the US.

India is also a favourite for investment in clinical research.

The Confederation of Indian Industries estimates that the biotechnology sector will attract investment worth US$5 billion by 2010.

Kiran Majumdar Shaw, chairman, MD, BIOCON, said: "The reason this is happening is because a large part of drug development is attributed to clinical development - recruiting patients, the speed and cost of these kind of trials all play a very important role in commercializing products.

“And again given the fact that India has a huge advantage in this particular space, I think we can create a large business portal out of this."

And unlike other sectors, a global meltdown is a boon for the biotech industry of India.

Indian biotech companies are working on acquiring units in US and Europe on the cheap, after their valuations fall.

There will also be more collaborations between foreign and domestic firms.

Mr Shaw continued: "I think you will see more and more collaborations, partnerships and joint ventures to bring down the cost and make this whole process more affordable."

But there is still scope for improvement.

India needs to revamp its educational infrastructure to build capacity in research.

Experts also said India needs a well-equipped national regulatory body to ensure that the industry meets global standards.

Despite being in a nascent stage, the growth rate of Indian biotech has been phenomenal. Since the last three years the industry has grown between 35 to 40 per cent. More innovations in medicine, engineering and even agriculture look set to come.

Source: Media Corp News

Pushing past the placebo: Legislating for a new kind of clinical trials

noreply@blogger.com (Lenith) — Mon, 24 Nov 2008 12:51:00 +0000

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

When drugs and devices go through the Food and Drug Administration approval process, they're compared with placebos. Few are tested in head-to-head trials. "They just have to be better than nothing," said David O. Barbe, MD, chair of the AMA Council on Medical Service, speaking on his own behalf.

Less than 0.1% of the money spent on health research is for studies that compare the effectiveness of two products.

Medical procedures often don't have clinical effectiveness data attached, noted Gail Wilensky, PhD, a former Medicare administrator and senior fellow at Project Hope, an international health advocacy organization.

But if some leading politicians and policy experts have their way, much more comparative-effectiveness research will be generated soon. In his health platform, President-elect Barack Obama calls for starting an independent institute to guide comparative-effectiveness research. In August, Senate Finance Committee Chair Max Baucus (D, Mont.) and Senate Budget Committee Chair Kent Conrad (D, N.D.) introduced a measure that would form a national entity to fund and oversee such research. The bill is expected to be at the center of congressional debate on the issue next year.

The concept of a national comparative-effectiveness body has support in the health care, insurance, consumer and public policy world. But many details, some controversial, must be worked out. How should the national entity be structured? Should it examine cost effectiveness as well? How will public and private payers use the data? How can patient-doctor decision-making be protected?

The rationale for more comparative effectiveness research is twofold: improving quality and lowering costs. Experts say providing the research results to physicians and the public will improve health care decision-making and thus boost quality. Meanwhile, giving the right treatment to the right patient would reduce spending on complications and hospitalizations. Another common belief is that many newer, costlier medical products or services would be found to offer little or no additional benefit than the older, less-expensive alternatives.

"I regard it as a strategy to help us learn how to spend smarter and treat better," Wilensky said, noting this will help slow the unsustainable health spending growth rate. The nation spent an estimated $2.2 trillion last year on health care, which is projected to nearly double by 2017, according to the Centers for Medicare & Medicaid Services.

Many doctors are interested in the benefits comparative effectiveness promises for the practice of medicine. "These are the questions that we as clinicians ask ourselves all the time -- what's the best treatment for my patient?" said Carrie Nelson, MD, program director for the Rush-Copley Family Medicine Residency Program in Aurora, Ill., and assistant professor in the Dept. of Family Medicine at Rush Medical College in Chicago.

The U.S. spent an estimated $2.2 trillion on health care services in 2007.

Most of the information doctors get about medications comes from drug reps who have conflicts of interest, said Dr. Barbe, a family physician. Doctors want more independent research on the comparative effectiveness of various medical options, Drs. Barbe and Nelson said.

Data also would strengthen the doctor-patient relationship, research advocates said. "It would help patients understand their situations so they can be truly informed participants in the decision-making process," said Neil Kirschner, PhD, senior associate for regulatory and insurer affairs for the American College of Physicians.

Some resources already exist for physicians who want this type of data. In 2003, Congress authorized the Agency for Healthcare Research and Quality to support comparative effectiveness research. AHRQ makes findings public through guides for patients, clinicians and policymakers. But experts view that effort and a few private initiatives as too fragmented and too small to have enough of an impact. Plus, there is no one place physicians can go to access data easily.

These issues have helped spur the call for a national research body.

"The need for a centralized, adequately funded comparative-effectiveness research entity is apparent," states an AMA Council on Medical Services report approved at the Association's Interim Meeting in November. The report includes nearly a dozen principles that the entity should follow, including that physicians and patients have a significant oversight role and that the research it sponsors be disseminated in a timely manner. The American College of Physicians also has formal policy calling for such a body.

What about costs?

Many in the health care community agree that the entity should be independent and protected from political pressure, have adequate and stable funding, involve all stakeholders, use rigorous scientific standards and operate transparently. But disagreements exist on whether the body should focus solely on clinical comparative effectiveness or also consider treatment costs.

Wilensky opposes having the body review costs because it is controversial and could jeopardize clinical effectiveness research. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said any initiative should focus on comparing health outcomes, not cost effectiveness.

Comparative effectiveness weighs medical treatments against each other, rather than against a placebo.

But some doctors want both efforts handled by the same body, as long as it's done with care. "Now the primary entity dealing with costs is the health plans," Dr. Barbe said. "It raises the issue of conflict of interest."

Creating separate infrastructure for cost analysis also would be wasteful, said Barbara McAneny, MD, chair-elect of the AMA Council on Medical Service, speaking on her own behalf.

If cost data came from an independent national entity, it would be trusted more, Dr. Barbe said. But findings on a procedure's clinical effectiveness should come first and be reported separately from cost-effectiveness data, he noted.

If two treatments are clinically equivalent, doctors need to know which one is less expensive, Dr. McAneny said. One of the profession's ethical obligations is to be an effective steward of the nation's limited health care resources, added the ACP's Kirschner.

More patients are seeking this information as insurers shift more costs onto them, Dr. Barbe said. "Physicians are in the best position to help them decide when it's worth it to spend more for a certain treatment."

Consumers Union, publisher of Consumer Reports, is comfortable comparing treatments' costs and clinical benefits. It does both in its Best Buy Drugs reports, noted Gail Shearer, the organization's director of health policy analysis and director of Best Buy Drugs. "People are ready to talk about value."

Limiting the entity's scope

The AMA and other physician organizations are adamant that any national entity not be involved in coverage or payment determinations, a position with which the trade group America's Health Insurance Plans agrees. But the data generated would help inform insurers' decisions, said Karen Ignagni, AHIP president and CEO. Medicare officials also are monitoring the research out of AHRQ.

Many experts predict payers will use the data to establish tiered co-pays for services, much as they do now for drugs. They also might take clinical and cost-effectiveness data into account in their payment policies.

Plans already make coverage decisions, only they're based solely on cost, Dr. Barbe said. Adding clinical-effectiveness data "will help us hold payers accountable. Right now, we don't have the information we need to say they're denying treatment they should not deny."

But the way plans might use the data raises concerns. Patients are not all the same, Dr. Barbe noted. A treatment deemed the most effective in general may not work for subgroups of patients because of factors such as age, sex, race or comorbidities.

Experts stress that treatment decisions must remain in doctors' and patients' hands and that an easily navigable exceptions or appeals process must be built into insurance coverage. That way patients who wouldn't benefit from the treatment generally accepted as most effective might be able to access an alternative without paying more.

Knowing which types of patients would benefit most from a given intervention will require more studies on subpopulations. Wilensky estimates that $4 billion to $6 billion per year should be invested in the research. Of the $2.2 trillion spent on health care annually, only 5% is dedicated to research, and less than 0.1% goes toward comparative effectiveness studies.

With the election of Obama and the interest from lawmakers, many policy experts predict that comparative-effectiveness legislation will get serious consideration in 2009, either as part of a larger health system reform bill or on its own. "It's a white-hat issue" that appeals across party lines, said Shawn Friesen, government affairs associate for the American College of Surgeons, which supports the idea of the research but has not yet adopted formal policy.

If a bill becomes law it will be years before a large enough body of evidence exists to have a major impact on medical practice and spending, notes a December 2007 Congressional Budget Office report. For research to have an effect, CBO notes, doctors and patients would need to use the data.

Physicians who do a particular procedure that is profitable might need to adapt if research finds it less effective than clinically equivalent, less-costly treatments, Kirschner said. This transition could at times be hard for them.

"People get used to doing what they do, and when they're asked to make a change that affects their livelihood, it's difficult," he said. "That's the human part of this."

Source: AMNews

Rural Population Key to China’s Clinical Research Market

noreply@blogger.com (Lenith) — Sat, 22 Nov 2008 09:19:00 +0000

In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

With Congress recently giving approval for the U.S. Food and Drug Administration to enforce post-marketing studies by fining sponsor companies for not doing them, the clinical research environment has become subject to more stringent requirements than expected. Engel described the fallout: Clinical trials are now larger than expected, their duration is longer and their requirements are broader. As an example, he said that any diabetes submission now requires a long-term cardiovascular surveillance study.

“There is a tremendous, rapid rise in surveillance projects in China,” Engel said.

He cited costs that were 30% of the U.S., access to patients and speed as factors in sponsor companies deciding to go to China. But, what will really drive the market in the future is the fact that more of China’s population will be insured in the coming years. More will be seeking medical care and will be able to spend money for it.

“The ruralization of healthcare is the next great driver,” he said.

Engel broke down the patient pool of 1.3 billion in China by insurance coverage: 250 million people have insurance coverage; another 250 million are partially covered by insurance; and 800 million have limited insurance coverage.

The rural population in China is rarely enrolled in a health insurance plan, but this will change, Engel said. In 2015, people living in rural areas of China will receive $150 each from the government to spend on medical care.

Twenty percent of longer-term patients in urban hospitals are already from rural areas, according to Engel.

Engel explained that there are 700 million people in the rural market, served by 1 million rural physicians and that there will be a rapid increase in rural physicians. There are already “significant programs to educate rural physicians” in place, he said.

Envisioning the China of 2015, Engel sees the number of products available increasing and the standard of care available improving. “Treatment regimens will change and the professionalism of physicians will change. Distribution costs to rural areas will drop 14% within the next four years.”

At that time, Engel also believes that “it will be much, much easier to enroll larger numbers of patients.” If clinical research infrastructure keeps up with the pace of ruralization of healthcare, China should continue growing its clinical research market.

Source: ClinicalTrialToday

CombinatoRx adds to job cuts; 55 remain

noreply@blogger.com (Lenith) — Fri, 21 Nov 2008 06:32:00 +0000

Weeks after cutting its staff levels nearly in half, CombinatoRx Inc. is increasing the number of cuts by an additional 30 positions. Combined with the 45 percent reduction announced on Nov. 5, the Cambridge-based company will now have reduced its staff size by 65 percent.

CombinatoRx (Nasdaq: CRXX) said it was undertaking the cuts immediately, so it can focus on identifying novel product candidates. The staff reductions should let the company run without a need for any more equity financing for at least four more years, officials said.

Following the cuts, CombinatoRx will have approximately 55 employees, mostly in research activities and partnering product assets. The company is also planning to consolidate its Cambridge facility, according to officials. CombinatoRx started its job cuts about one month after disappointing trial results for Synavive, a drug intended to treat knee osteoarthritis,

In its Phase 2b clinical trial of Synavive, CombinatoRx found a placebo and Synavive turned up statistically insignificant results in a knee pain measurement test for patients walking on a flat surface. As a result of the clinical trials results, CombinatoRx stock dropped 73 percent at about 11 a.m. on Oct. 4, the day it announced the failed test, from $3 per share to 80 cents per share.

Last October, CombinatoRx reported it had signed definitive agreements with unnamed institutional investors to sell up to 5.6 million shares of its common stock, raising a combined $35 million in a registered direct offering.

CombinatoRx reported a net loss of $53.3 million on total revenue of $15 million in 2007.

SuperGen gets FDA approval for clinical trial

noreply@blogger.com (Lenith) — Fri, 21 Nov 2008 05:04:00 +0000

SuperGen Inc. has received clearance from the Food and Drug Administration to begin clinical trials of an anticancer compound, triggering a $5.2 million milestone payment from SuperGen.

With the approval of the new-drug application, Dublin-based SuperGen (NASDAQ: SUPG) will pay a $5.2 million milestone payment to the former stockholders of Montigen Pharmaceuticals Inc., with the consisting of $2.8 million in cash and approximately $2.4 million in equity, representing approximately 1.5 million shares of SuperGen common stock.

The study will evaluate the safety and tolerability of SGI-1776, an orally administered, small-molecule anticancer compound.

The first clinical trial program will enroll patients with solid tumors, with specific emphasis on hormone refractory prostate cancer and refractory non-Hodgkin's lymphomas.

Source: Business Times

Viagra firm abandons EU action

noreply@blogger.com (Lenith) — Fri, 21 Nov 2008 05:03:00 +0000

The makers of anti-impotence drug Viagra have withdrawn their bid to make it available without a prescription.

Drug company Pfizer had wanted to make 50 milligram tablets freely available in the European Union.

But in a letter to the European Medicines Agency (EMEA), Pfizer said it would withdraw the application in the light of concerns from EMEA's Committee for Medicinal Products for Human Use.

A spokeswoman for EMEA said: "One concern was that its use with a lack of proper medical supervision could delay diagnosis of the underlying causes of erectile dysfunction which can include heart disease."

Viagra, the marketing name of the drug sildenafil citrate, overcomes impotence by blocking an enzyme that limits blood flow to the penis.

Rory O'Connor, Pfizer's vice president of Medical and Regulatory Affairs, said: "Sildenafil citrate has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials.

"We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies."

Pharmaceutical Industry Hustlers - Part II

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:38:00 +0000

By Evelyn Pringle on November 18, 2008

Pushers of SSRI Antidepressants. To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.

Collectively, these antidepressants are referred to as SSRI's (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.

The drug companies, "by their sheer economic clout," have become the single most dominant influence in our healthcare system, and the "ambiguities of children's mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence," says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, "The Last Normal Child," in the July 13, 2008, San Francisco Chronicle.

"In this climate," he explains, "drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches."

That is why we are seeing famous (or infamous) Newsweek cover boys - like a 10-year-old "who has taken 38 psychiatric medications in his short, unhappy life," he says.

Dr Joseph Glenmullen, author of "Prozac Backlash," testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.

Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a "most dangerous scenario" when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.

He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.

He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. "How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?" he asked.

"Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality," he pointed out.

Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. "Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists," says Dr Diller.

He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs "not only because it is expensive, but because they don't really want to find out whether their drugs continue to work over time or if long-term side effects develop," he states in the paper, "A Prescription for Disaster," published by Salon.com on May 23, 2002.

"Currently, that kind of research is a job for the country's trial lawyers," he writes.

"But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature," Dr Diller points out.

Highly Paid Hustlers in motion

The "failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children," according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, "Children in Clinical Research: A Conflict of Moral Values," published in the American Journal of Bioethics.

No SSRI was approved for children before 2003. However, by "the early 1990's, it didn't matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old," says Professor Jonathan Leo in the 2006 paper, "The SSRI Trials in Children: Disturbing Implications for Academic Medicine."

He points out that "the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist," he says, "the profession endorsed the use of them well before any of the major studies in children were even published."

"It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns," according to Professor Leo.

"If a trend is created 'because everyone else is doing it' then it appears that the child psychiatry profession's use of these drugs in the late 1990's more closely resembled a trend instead of a logical scientific undertaking," he explains.

The first major studies claiming SSRI's were safe and effective for children began to appear in the late 1990's. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the "well-accepted prescribing patterns," to doctors in every field of medicine, there are the names of the same "Highly-Paid Hustlers,” also known as "key opinion leaders," because they are supposedly so highly respected by their peers.

They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as "manic-depression" was now "bipolar disorder," and in the mid-90's, Dr Biederman, and a few more "opinion leaders" started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.

"Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill," says Dr Diller, in an article entitled, "Are Our Leading Pediatricians Drug Industry Shills?" in the July 13, 2008, San Francisco Chronicle.

"Biederman and his team," Dr Diller writes, "are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs."

"The science of children's psychiatric medications is so primitive and Biederman's influence so great," he says, "that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs."

"This happens in the absence of a drug trial of any kind - instead," Dr Diller notes, "the decision is based upon word of mouth among the 7,000 child psychiatrists in America."

"That's why Iowa Sen. Charles Grassley's recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic," he says.

"If true," Dr Diller notes, "this scandal is yet one more stake in the heart of American academic medicine's credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day."

Until the "bipolar" profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.

Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.

In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.

Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the "respectable" medical journals continue to publish this kind of trash.

He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.

This "Preschool Psychopharmacology Working Group" claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. "The purpose of this effort," the authors note, "is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications."

Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.

On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the "pharmaceutical giant Pfizer."

Judging by the results of this "study," the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of "disorders" is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the "Terrible Twos."

Sad aftermath

Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, "Medication Madness."

Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with "drug-intoxicated brains."

Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.

Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that "young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood."

"They rely on a false belief that drugs can solve problems," he says, "rather than relying on their own innate creative potential or the help of family, friends, and schooling."

"Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients," Dr David Healy explains in the 2006 paper, "The Latest Mania: Selling Bipolar Disorder." But he says:

"All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine."

"The extensive prescription of these medications for children," Dr Diller warns, "without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties."

"Catastrophic side effects may be rare," he says, "but they become predictable when we treat so many children with so many drugs."

"There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit," says Dr Fred Baughman, author of, "ADHD Fraud - How Psychiatry Makes Patients of Normal Children."

"Because the children made into 'patients' are normal to begin with," Dr Baughman contends, "those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning."

"What should we call it when children die pursuant to a fraudulent diagnosis," he asks. "First degree murder? Second degree murder? Justifiable homicide? Manslaughter?"

In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: "It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today."

There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. "For us it has been four and a half years without resolution or closure," says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.

"Every day hurts," Mathy says. "One never gets over the loss." Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.

They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.

The Downings would later learn that their daughter’s physician was on Pfizer's payroll. "Although we realize that Candace's doctor only made about $12,000 acting as a Pfizer consultant, it's not the amount that bothers us," Mathy says.

"It's the medical compromise. It's the lack of informed consent. It's placing economical gain above the well-being of an innocent child and a trusting family," she states.

"I just want to know when 'Greed before Need' will diminish and doctors will once again place a patient's well-being first," she says, "before financial gain."

"What has happened to the Hippocratic Oath that doctors are supposed to take?" Mathy wants to know.

Rough estimates

In "Let Them Eat Prozac," Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.

These figures made it possible for him to estimate how many people had made suicide attempts. "If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac," he writes, "then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used."

"Conventional wisdom is that there is one suicide for every ten attempts," he explains. "These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents."

Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. "The FDA estimated their database picked up only between one and ten per cent of serious adverse events," he writes.

"This gives a spread between 20,000 and 200,000 suicides on Prozac," he concludes.

There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.

"If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly," he warns in a June 2003 briefing paper on "Antidepressants and Suicide."

Read Pharmaceutical Industry Hustlers – Part I

Source: bestsyndication

Fisher BioPharma mulls additional unit in Gujrat, India

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:33:00 +0000

Fisher BioPharma, a part of the US-based Thermo Fisher Scientific Inc., is now mulling an additional unit at its upcoming clinical trials logistics management facility in the Pharma Special Economic Zone (SEZ) here in Gujarat. The unit could be of one of its sister concern companies which might be present in domains like design services, support services, project management and IT services.

Provider of a complete range of high-end analytical instruments as well as laboratory equipment, Thermo Fisher Scientific Inc., through Fisher BioPharma has set up a packaging, distribution and logistics management facility for tightly regulated pharmaceutical samples to patients participating in clinical trials across the globe.

“Having set up this facility, we are evaluating whether any of our sister concern laboratory companies or support services companies that cater to our Europe and US facilities could come up here as well. These companies could be in domains like design services, support services, project management or IT services,” said Heinz Stamm, president (Europre and Asia), Fisher BioPharma.

The current logistics management facility has been set up at an investment of around $ 17 million (Rs 68 crore approx.) on an area of 150,000 sq ft. The facility complements the company's existing clinical services operations in the US, Europe and Asia.

By next year, Fisher BioPharma expects to bag anywhere between 50-100 trials from India. “We are not clinical research organisations. Rather we are into logistics management of these trials. In India, there are around 900 such trials going on which are spread across the world. We expect to bag anywhere between 50 and 100 such trials in the coming year,” said Ram Gupta, president and managing director.

“India continues to be a major market of focus for us as we expand our capabilities to support clinical research and development,” said Marijn Dekkers, president and chief executive officer of Thermo Fisher Scientific.

Thermo Fisher now has a larger presence in India with more than 600 employees and 20 facilities, including the new full-service clinical packaging and distribution facility at Ahmedabad. The estimated revenue from India in 2008 for the company is around $ 125 million (Rs 500 crore approx.).

Source: Business Standard

Quintiles, SAS Announce Development of First-Ever Clinical Trials Statistical Programming Certification

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:27:00 +0000

Quintiles, the world's No. 1 pharmaceutical services company, and SAS are developing a unique program to produce certified specialists in the use of SAS programming to evaluate clinical trials results, the companies announced today.

The Quintiles-SAS Clinical Trials Statistical Programming Certification will certify that the successful candidate has shown that he or she has the expertise necessary to organize, analyze, and report clinical trials results. Incorporating industry-specific data, language and concepts, SAS and Quintiles will develop an exam and related training materials that emphasize the SAS skills statistical programmers need in the pharmaceutical and biotechnology industries.
"We're responding to a customer need through this collaboration with Quintiles," said Herbert Kirk, Vice President, SAS Education Division. "The pharma and biotech industries have statistical requirements that our standard certification exams don't measure. With this new certification, our pharma customers can hire people with confidence."

Michael Fiola, Senior Director, Quintiles Global Biostatistics, said, "This initiative demonstrates Quintiles' commitment to advanced training in the statistical evaluation of clinical trial results, which is altogether fitting for a company founded by biostatisticians. We believe we have the industry's most talented, best trained and most highly engaged workforce to help our customers develop and deliver better medicines more quickly. This program illustrates our dedication to delivering the best clinical trials statistical programming in the world."
Fiola says development of the Quintiles-SAS Clinical Trials Statistical Programming Certification program is expected to be completed and ready for release in time for the Pharmaceutical SAS Users Group Conference in Portland, Oregon, May 2009.

About Quintiles
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, strategic partnering and commercialization for the pharmaceutical, biotechnology and medical device industries. With more than 22,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's Web site at www.quintiles.com.

About SAS
SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. With innovative business applications supported by an enterprise intelligence platform, SAS helps customers at 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world THE POWER TO KNOW(R).

SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. (R) indicates USA registration. Other brand and product names are trademarks of their respective companies. Copyright (C) 2008 SAS Institute Inc. All rights reserved.

Source: Marketwatch

Wyeth claims no GCP lapse as India suspends vaccine trial

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:22:00 +0000

Wyeth says that there were no GCP (good clinical practice) lapses in its now-suspended Indian pneumococcal conjugate vaccine trial. The Drugs Controller General of India (DCGI) halted the trial following the death of an infant, alleging that the company had flouted the inclusion-exclusion criteria for the study.

The Wyeth study aimed to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared with Prevenar (PCV7), when given concomitantly with routine paediatric vaccinations in India. Wyeth's Prevenar is available in more than 90 countries and is part of the national immunisation programme in 29 of these.

The trial, which was being conducted across India in Chandigarh, Maharashtra, New Delhi, Punjab, Tamil Nadu and Karnataka, has been suspended pending the DCGI's review of the case. The study involved a total of 354 infants in each of two cohorts, the first of which was completed earlier. The second cohort is subject to the suspension.

Source: SCRIP

Adolescents are under-represented in clinical research

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:14:00 +0000

Recent European legislation designed to increase the number of children in clinical trials has had a positive impact in ensuring that paediatric patients are included in medicine testing.

But a commentary published in the journal Clinical Pharmacology & Therapeutics(December 2008 issue) argues that adolescents remain overlooked by clinical researchers.

The authors - Bill Kapogiannis and Donald Mattison – point out that data collated by the US National Institute for Allergy and Infectious Disease (NIAID) found that only 5.4 per cent of 9,500 participants in HIV trials conducted at the institute were adolescents, while other research indicates similarly low levels in cancer studies.

They suggest that low participation rates in trials may be one reason why adolescents experience poor survival rates in cancer trials compared to children and adult patients

Kapogiannis and Mattison believe that it is critical that adolescents are actively recruited into clinical trials in order to avoid the risk of unpredictable pharmacological responses to medicines.

Physical changes, such as puberty, can change adolescent patients’ response to medicines, they note. And “in addition to physical changes, adolescents are susceptible to psychosocial factors that can affect taking the drug as directed, and place them at risk for additional disorders,” according to Kapogiannis and Mattison.

Adherence to medication regimens is a well-recognised problem with adolescents. Peer pressure, a wish to be more independent, and the use of illicit drugs or alcohol and mood disorders are all factors that are seen with adolescents and can impair compliance.

“Adolescents are exposed to many marketing campaigns and are at risk for misuse of products, but few studies look at this group,” write the authors. For example, studies suggest a third of adolescents use over-the-counter medicines at higher than the recommended label dose

Kapogiannis and Mattison also point out that the high rate of clinical trials in children masks the fact that in many cases they involve drugs predominantly marketed and used in adults.

Increasing the recruitment of adolescents into trials requires a wide-ranging approach that solves challenges relating to “trial design, safety, legal, ethical, regulatory, and operational factors,” according to the authors.

“Ethical research with adolescents should focus on two goals: protection from research risk and appropriate inclusion in clinical research that will improve our understanding of therapeutics,” they conclude.

Source: Outsourcing-pharma.com

Innovative Clinical Trial Design and Management - Trends, success stories and impact upon research and development budgets - Report Summary

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:08:00 +0000

Innovative Clinical Trial Design and Management
Trends, success stories and impact upon R&D budgets

Report overview Key findings...

The costs associated with developing drugs have risen dramatically over the past decade and fewer drugs are obtaining regulatory approval. The pharmaceutical industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs.

These innovative clinical trial designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

‘Innovative Clinical Trial Design and Management’ is a new report published by Business Insights that explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of the potential cost and time savings that innovative trial designs can offer throughout the clinical development process.

Use detailed case studies to explore recent adaptive trial implementations, identify the companies pioneering and supporting innovative designs and understand the most effective planning and logistics strategies... 15

Key findings...

Major pharma companies are implementing adaptive trials to improve dose-finding in the Phase 2 setting. The use of adaptive clinical trials will increase across the industry over the next 2-3 years.

Adaptive clinical trial designs are more effective than traditional designs in cases where there is uncertainty surrounding the dose, effect size and variability, clinical endpoint or patient populations.

The planning and execution of adaptive designs is more complex than the traditional approach. Successful implementations require teams of statisticians, data managers, clinicians and drug supply and logistics managers to work together as early as possible.

Predictive biomarkers have been found to require detailed prospective analysis far earlier in the clinical development process, and with the same clarity as traditional drug approvals. Post-hoc correlations were previously thought to be good enough for identifying the biomarkers used to predict the patients most likely to respond well to a new treatment.

Regulatory authorities are supportive of adaptive trials, particularly in the Phase 2 setting. However, there are concerns over the confidentiality of data and companies have been asked to demonstrate that the parties involved in running the study will remain unaware of ongoing adaptations.

Key questions answered...
• How can adaptive trials improve the success rates of clinical drug projects?
• How are pharma companies implementing adaptive trials and what major hurdles can prevent such implementations?
• What is the position of the FDA and EMEA in regards to different types of adaptive trial?
• How can logistical and strategic planning be managed most effectively?
• Which companies are offering services to support adaptive clinical trials?
• Which companies are co-developing drugs and diagnostic products?

Key issues examined by this report...

• Adaptive trial implementations. The aim of adaptive trials is to improve the information value of clinical trials whilst maintaining their integrity and validity. The use of adaptive trials in the early phases of drug development should yield better information and lead to the earlier termination of unsuccessful compounds.

• Dose finding improvements. The availability of new Bayesian study designs that acknowledge prior information and allow for the testing of a wider range of doses has enabled more accurate dose-finding. This may have important consequences for the success of future Phase 3 clinical programs

• Seamless trial speed. Major pharma companies are interested in the prospect of combining drug development phases into ‘seamless trials’, with the potential to reduce the length of clinical development programs in the Phase 2b/3 setting

• Regulatory issues. Engaging with the FDA/EMEA during the protocol design stages of an adaptive trial is important, especially for studies intended for use in packages of pivotal clinical data. The EMEA’s current position on adaptive clinical trial design is summarized within a reflection paper published in October 2007, while draft FDA guidance is expected in 2008.

Source: Companiesandmarkets.com

Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cance

noreply@blogger.com (Lenith) — Thu, 20 Nov 2008 05:03:00 +0000

Amgen and Millennium: The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4052), today announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee (DMC). Motesanib is part of a broad co-development program between Amgen and Takeda.

The DMC recommended that enrollment in the study, which allowed both squamous and non-squamous NSCLC patients, be suspended based on an observation of higher early mortality rates in the motesanib group compared to the placebo group. In addition, the DMC recommended that the patients with squamous NSCLC immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis. The DMC did not recommend discontinuation of motesanib therapy for the patients with non-squamous NSCLC. The DMC will review updated data after three months.
Amgen, in collaboration with Takeda Bio Development Center, is implementing both of the DMC's recommendations and notifying worldwide regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), as well as motesanib clinical investigators.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors."
"NSCLC continues to be an area where new and effective therapies are needed. We look forward to the follow up recommendations from the DMC in order to chart the best path forward for the development of this molecule," said Nancy Simonian, M.D., chief medical officer, Millennium: The Takeda Oncology Company.
MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design
This Phase 3, multicenter, randomized, placebo-controlled, double-blind trial has enrolled 1,100 of 1,240 planned patients with advanced NSCLC. Patients with either squamous or non-squamous NSCLC were allowed in this study. Squamous NSCLC is a histological subtype of NSCLC and accounts for approximately one-third of the study population. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate in patients with measurable disease, duration of response and safety. Patients were randomized 1:1 to receive carboplatin and paclitaxel administered every three weeks with or without 125 mg motesanib taken daily.

About Motesanib
Co-developed by Amgen, Takeda Pharmaceutical Company, and Millennium: The Takeda Oncology Company, motesanib is an investigational, highly selective, oral agent that is being evaluated for its ability to inhibit angiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3). It is also under investigation for its potential direct anti-tumor activity by targeting a family of proteins called tyrosine kinases, including platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (c-kit), two proteins involved in cell proliferation.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disorder, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com.
About Takeda
Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com.

About Millennium
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, http://www.millennium.com.

Source: MarketWatch

UTMB employees get notice of layoffs

noreply@blogger.com (Lenith) — Wed, 19 Nov 2008 04:45:00 +0000

The dreaded day has arrived for thousands of UTMB employees in Galveston. The hospital has begun the process of notifying the workers of exactly who is getting laid-off.

University of Texas Medical Branch (UTMB) workers have known about the layoffs for more than week, but that does little to lessen the blow of losing your job.Most of those individuals who are being notified today that they are losing their jobs are being told face to face, through a phone call or through an email. They all primarily worked in the clinical side of things at the hospital. Most of those workers have not been at work because they haven't been able to return to the hospital after Hurricane Ike damaged the building so badly.

"Yeah, it's time to go. I got my orders," said unemployed worker Tino Gonzalez. For the last 20 years, Gonzalez has worked in Human Resources at UTMB. He is among the 3,000 employees who no longer have a job.

"Everybody is kind of nervous about it," said UTMB spokesperson John Kolen. "And I don't think really a whole lot of people want to be here today to get the bad news or to give the bad news."

"I don't know yet, but I will be OK," said employee Katsuhiro Kiat, PhD.

Kiat works in the research department and although cuts will be made in his department he doesn't feel his job will be lost. He does think that the UTMB Board of Regents is using the damage caused by Hurricane Ike as an excuse for needed downsizing.

"Unfortunately, I would say the storm and the financial across of the state could have exposed the weakness of this institution. That is what I can see," said Kiat.

By the end of the year, the 116 year old institution will be scaled down to a 200 bed unit. The hospital's spokesman John Kolen says it could be years before the hospital is fully operational as it was before Hurricane Ike.

"It would be ideal if we could hire back former employees but by the time we are ready to hire them back, they will more than likely have already found jobs," said Kolen.

Mr. Gonzalez told Eyewitness News he was going to take the advice of his 13-year-old son who told him to take a couple of weeks off and maybe start looking for a job at the beginning of the year.

UTMB is staffing two Employee Help Centers, one centrally located on the mainland and one on the island (http://www.utmb.edu/utmbemployeehelpcenter). Both centers are open 8 a.m.-5 p.m., Monday through Friday. Services and resources include job search counseling, job fairs, training on interviewing, resume writing and online job searches, employee benefit and retirement counseling, financial counseling and training, and counseling for personal issues.

Tomorrow, UTMB will be notifying more employees and hope to have everyone notified by the beginning of next week.

Source: ABC13

DATATRAK Adds Diverse Lynx to Its CRO Connect Program

noreply@blogger.com (Lenith) — Wed, 19 Nov 2008 04:27:00 +0000

DATATRAK International, Inc. , a technology and services company focused on global eClinical solutions for the clinical trials industry, today reported that it has signed Diverse Lynx to its CRO Connect program.

DATATRAK's CRO Connect program is a non-exclusive enterprise agreement and accreditation relationship that empowers CROs to design and deploy their own EDC trials using DATATRAK's unified eClinical platform. As a CRO Connect partner, Diverse Lynx will be able to offer eClinical services to its clients through a standardize offering.
"We are pleased to add Diverse Lynx to our CRO Connect program," stated Dr. Jeffrey A. Green, Chief Executive Officer of DATATRAK International, Inc. "Collaboratively, this program allows Diverse Lynx to offer our standardized eClinical platform to best serve their sponsor's clinical trial needs. Our CRO model allows them to offer very predictable research and development costs while eliminating wasted time involved with negotiation and contracting under the trial-by-trial mode. This model has tremendous advantages to DATATRAK and Diverse Lynx with solid visibility of revenues over a multi-year period of time combined with a greatly diminished cost of sales."
"Our partnership with DATATRAK International is a big step towards offering absolute clinical data management services for data capture, processing, analysis and management services in the most cost effective approach with the highest quality. We now have a strong data management infrastructure to match our organization in Europe, Japan and Asian countries, covering over 20 countries," said Shubhendra Varma, President of Diverse Lynx. "At Diverse Lynx, we take this partnership several steps further by emphasizing long-term, value-added relationships and a commitment to understand our sponsors' business needs."

About DATATRAK International:
DATATRAK International, Inc. is a worldwide technology company focused on the provision of multi-component eClinical solutions and related services for the clinical trials industry. The Company delivers a complete portfolio of software products that were created in order to accelerate clinical research data from investigative sites to clinical trial sponsors and ultimately the FDA, faster and more efficiently than manual methods or loosely integrated technologies. DATATRAK's eClinical software suite can be deployed worldwide through an ASP offering or in a licensed Enterprise Transfer model that fully empowers its clients. The DATATRAK software suite and its earlier versions have successfully supported hundreds of international clinical trials involving thousands of clinical research sites and encompassing tens of thousands of patients in 59 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 16 drugs and one device that have received regulatory approval from either the United States Food and Drug Administration or counterpart European bodies. DATATRAK International, Inc. has offices located in Cleveland, Ohio, and Bryan, Texas. Its common stock is listed on the NASDAQ stock Market under the ticker symbol "DATA".

Visit the DATATRAK International, Inc. web site at www.datatrak.net .

About Diverse Lynx:
Diverse Lynx is a rapidly growing Information Technology and, Clinical Research and Data Management Company focused on providing contract research services to develop drugs and clinical trials to leading pharmaceutical, Biotech companies and government agencies globally. Its IT division provides a litany of diverse services that include staff supplementation through workforce contracting, e-business consulting, web-based applications, Client Server Applications, network solutions and other in-house and offshore software developments. Its Clinical Trial & Data Management division offers clinical research support to the global pharmaceutical industry and supports sponsors in their clinical trial management, pharmacovigilance and safety risk management, data management and regulatory affairs in the area of Oncology, Neurology, Psychiatry, Cardiology, Nephrology, Infectious Diseases and therapeutics vaccines. Headquartered out of New Jersey, USA with an office in India, Diverse Lynx has collaboration throughout Europe as well as in Japan and Russia. For more information please visit Diverse Lynx website at www.diverselynx.com .

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management's expectations and beliefs concerning future events impacting the Company and are subject to uncertainties and factors (including those specified below) which are difficult to predict and, in many instances, are beyond the control of the Company. Factors that may cause actual results to differ materially from those in the forward-looking statements include the limited operating history on which the Company's performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs; fluctuations in the Company's quarterly results; the viability of the Company's business strategy and its early stage of development; the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; the Company's dependence on major customers; government regulation associated with clinical trials and the approval of new drugs; the ability of the Company to compete in the emerging EDC market; losses that potentially could be incurred from breaches of contracts or loss of customer data; the inability to protect intellectual property rights or the infringement upon other's intellectual property rights; the Company's success in integrating its acquisition's operations into its own operations and the costs associated with maintaining and/or developing two product suites; and general economic conditions such as the rate of employment, inflation, interest rates and the condition of capital markets. This list of factors is not all inclusive. In addition, the Company's success depends on the outcome of various strategic initiatives it has undertaken, all of which are based on assumptions made by the Company concerning trends in the clinical research market and the health care industry. The Company undertakes no obligation to update publicly or revise any forward-looking statement.

Source: MarketWatch

Clinical Trials: Dying for Access

noreply@blogger.com (Lenith) — Tue, 18 Nov 2008 13:50:00 +0000

It costs on average $802 million to develop a new drug, but not every drug makes it to market. Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.

From a bright and beautiful teen to a woman with wisdom and compassion beyond her 21 years, Abigail Burroughs fought hard before losing her battle with neck cancer. In the last seven months of her life, she not only fought her disease, but the federal government as well.

"I wish that they would just sit down and get to know me and then be able to sit down and look me in the eye and tell me, 'No,'" she said in an interview before her death.

The Food and Drug Administration refused Abigail access to a drug that may have prolonged and even saved her life. After she died, the drug she was fighting for -- Erbitux -- was approved.

"There is just this mindset that if we have any kind of change it will hurt the clinical trial system," said Frank Burroughs, Abigail's father.

Abigail's father created the Abigail Alliance to take her fight to Capitol Hill. The ACCESS act, before the house and senate right now, allows terminally ill patients who have exhausted all other options access to investigational drugs.

"There's a lot of lives that could be saved and extended ... tens of thousands of lives," Frank said.

Even Steve Walker and his wife Jennifer, both scientists, well versed in policy, government regulations and research, were no match for the FDA. Stage four colon cancer ravaged her body.

"Jennifer was 45 years old at the time and far from done with making her mark in life," Walker, co-founder of the Abigail Alliance, told Ivanhoe. "We intended to beat it, but being scientists, we knew very quickly that the chances of doing that were not good."

They talked with the FDA for months to get aggressive drugs already approved in 29 other countries.

"They don't work with you if you're a patient," Walker said. "In fact, they do the opposite. They aggressively serve and function as a barrier against your attempts to stay alive."

Some experts believe using experimental drugs could end in disaster.

"I don't think patients are in need of experimental drugs," Colin Begg, Ph.D., a board member on the Society for Clinical Trials, said. "What they are in need of are drugs that actually work."

The Society for Clinical Trials opposes the ACCESS legislation calling it "a bad law." it claims the history of medicine proves many drugs that initially seem promising are later revealed to be worthless or harmful.

"Statistics show that 90 percent of all drugs that pass phase 1 testing are ultimately shown to be ineffective or too toxic," Dr. Begg explained.

It typically takes pharmaceutical companies six years after discovering a promising molecule to gather enough data to begin clinical trials. Completing a trial takes another seven years. The FDA says it's time well spent. Cheri Gunvalson says it's time her son doesn't have.

"I believe that there will be nothing more difficult on this earth than to watch my child deteriorate and to lose my child," Cheri Gunvalson said. Her son Jacob is living with a rare form of muscular dystrophy.

"I have hope to just get this drug … to just get it before it's too late," Jacob said.

In August, a federal judge ordered the drug developer PTC therapeutics to give Jacob the experimental drug that could stop the progression of his disease. An appellate judge has since granted a stay, stopping Jacob from getting the drug right now

"With younger boys, it may help them get stronger, but with a boy at Jacob's stage, it's just to preserve what he has, so the longer we wait, the less function he has left to preserve," Cheri explained.

"What's got me down? That I might not get this drug, and if I don't get this drug, we all know what that means," Jacob added.

Experts fear granting early access to patients like Jacob means other patients won't sign up for controlled clinical trials.

"It's likely there will be a disincentive to patients to actually participate in the kinds of trials that will tell us in the long run what drugs work and which ones don't," Dr. Begg said.

"Nothing could be further from the truth," Frank said. "A patient would have to first try to get into a clinical trial and if they could not get into a clinical trial, then they could have access to a new drug that's in development."

"The doctors would have all these choices, but they wouldn't have any evidence," Dr. Begg stated.

"These are not drugs, these are not therapies, these are research activities and people need to understand that." said Michael A. Grodin, M.D., professor and director of the Law, Medicine, Ethics and Human Rights Program at Boston University in Mass.

"Those patients are literally being driven to the grave by an FDA that doesn't know how to get out of the way," Walker remarked.

The two drugs the Walkers fought are now approved by the FDA. All 16 drugs the Abigail Alliance requested earlier access to are now approved.

"Over a million people who could have benefitted from these drugs never had a chance to get them," Frank said.

The Alliance is focusing on approval of nine more cancer drugs. Although it's too late for his daughter, Frank and the others will push forward for the lives they've lost and the lives they may save.

"I work every day for her, but I work every day for a lot of other people," Frank explains.

"Jennifer didn't want help just for her … she wanted help for everyone," Walker said about his wife.

"I need to know at the end of the day that I've done everything that I can to save his life," Cheri said.

The ACCESS act also pushes for placebo-free drug trials in hopes more people will get involved in clinical trials if they know they will be receiving the drug in question.

Source: News4jax

Clinical trials needed to speed cancer fight

noreply@blogger.com (Lenith) — Tue, 18 Nov 2008 12:57:00 +0000

THE RECENT $13.5 million award against two cancer doctors at Dana-Farber is a travesty ("$13.5m awarded in hospital death," Metro, Nov. 6). It is always sad when a cancer patient dies. Amy Altman had an extremely rare and difficult-to-treat tumor known as Ewing's sarcoma.

I am sure as a participant in a clinical trial, she signed an informed consent and acknowledged beforehand that severe complications, including death, could occur. Unfortunately, she died from the adverse effects of chemotherapy and her weakened immune system. To argue, as the patient's lawyers did, that her cancer doctors "wrote off" her diarrhea and that her death could have been prevented is untenable.

There is a real downside to cases such as this one. There has not been a new drug approved in the United States for sarcomas in over 25 years. The only way in which breakthrough medicines will be approved is through rigorous clinical trials. Without patients participating in trials, drug development will stop, and progress toward curing cancer will end. If this unjustified lawsuit scares patients and doctors from taking part in clinical trials, great harm will come to cancer patients in dire need of new treatments.

Misguided malpractice lawyers should think twice before they destroy the very system of clinical care and research that is needed to develop new cancer drugs. One day, they may also be patients.

HARVEY J. BERGER, M.D., Cambridge
The writer is chairman and chief executive of ARIAD Pharmaceuticals. The Dana-Farber Cancer Institute and the Center for Sarcoma and Bone Oncology are participating in clinical trials of a drug developed by the company for those with sarcomas and other solid tumors.

Source: The Boston Globe