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Snake venom could help drug discovery

Tue, 09 Mar 2010 18:18:00 +0000

According to a new report, snake venom could be used to advance drug discovery. The claim, which is made by researchers at the University of Singapore, says that venom contains a protein that has the potential to advance the understanding of disease mechanisms.

Called haditoxin, the novel protein was reportedly discovered by Professor Manjunatha Kini at the National University of Singapore. Now, co-author of the report that characterises the pharmacological potentials of haditoxin, Dr. S. Niru Nirthanan, says that the protein boasts a unique structure and is therefore expected to have unique properties that can used in the drug discovery arena.

The findings come at an interesting time for the pharmaceutical industry, given that patent protection on many drugs are facing expiration and, with the rise in generics, pharmaceutical companies are now looking at a series of new measures to encourage drug discovery so they can "plug the gaps" that will be left after existing drugs lose their patent protection.

How it works

"This toxin is like a conjoined twin," explains Dr. Nirthanan. "It is a relatively large complex made up of two identical protein molecules known as three-finger toxins linked together.

"We know that the family of three-finger toxins display diverse biological actions on the human nervous system, cardiovascular system and blood clotting. Some have directly led to the development of compounds with potent analgesic and blood pressure reducing properties – so it is likely that haditoxin in its 'conjoined twin' state or as individual components will offer us more novel insights," he added.

The authors of the report also added how many common drugs, such as the widely prescribed blood pressure medication Captopril and anti-clotting drug Eptifibatide, have been developed from snake and other animal venoms.

Getting an understanding

"Researchers have been studying King Cobra venom for over 50 years and yet we are still identifying new compounds. It is a complex cocktail of biological molecules that can change composition depending on the environment, the season or even the snake's diet," Dr. Nirthanan added.

According to the study, the venom, which acts on neurotransmitter receptors that regulate communication between nerve cells and muscles, resulting in symptons such as paralysis and respiratory failure, may be able to be managing so the mechanism of action of these venoms can be better understood.

While researchers suggest that not every new toxin will convert directly into a clinically useful drug, there was potential for haditoxin to be a lead compound or template from which to design other drugs. "Because of the high specificity of these toxins, haditoxin may also be useful as a 'molecular probe'," Dr. Nirthanan concluded, "which will help us study neurotransmitter receptors and their role in disease."

The study has been described in the prestigious Journal of Biological Chemistry.

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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FDA pledges more criminal prosecutions

Mon, 08 Mar 2010 07:56:00 +0000

The FDA has this morning announced plans to increase criminal prosecutions of "responsible corporate officials," according agency Commissioner Margaret Hamburg.

Her comments come in a letter dated 4 March to Republican Senator Charles Grassley, following a highly critical investigation of the US Food and Drug Administration's (FDA) oversight of its Office of Criminal Investigations (OCI), which reported this week that the agency is not fulfilling its required assessment of the six OCI field offices.

"Of the 24 total office assessments that should have been completed by August 2009, only seven, or about 30 percent, were completed, and one office had not been assessed in over 10 years," says the report of the investigation, conducted by the Government Accountability Office (GAO) at the request of Sen. Grassley.

What's more, while the OCI's director meets weekly with a senior official in the Office of Regulatory Affairs (ORA) - the FDA office in which OCI is located - the OCI is not required to report specific information to ORA or other FDA senior-level offices as part of its formal reporting relationship.

GAO investigators have reportedly been told by the OIA manager that the number of investigations is such that he is generally involved in all of them, and can therefore review investigative documents before closing cases to assess compliance with investigative policies.

Compliance

His review alleviates the need for a process to monitor compliance with OIA's investigative policies, according to reports. However, the investigators comment: "the potential effectiveness of this review is limited because it relies on the OIA manager, who is also responsible for supervising investigations."

Among its recommendations for improvements, the GAO says the FDA should establish performance measures for the OCI, monitor it regularly, and set up a process to monitor the OIA for compliance with its investigative policies.

Commenting on the report's findings in her letter to Sen Grassley yesterday, Commissioner Hamburg says the agency accepts its concerns and is already working on improvements, including an increase in "the appropriate use of misdemeanour prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable."

Sen. Grassley responded that the GAO report had "made a difference already by securing a much-needed commitment from the Commissioner to make the FDA's investigative unit live up to its significant responsibilities."

He added that there is no excuse for the fact that this division's failures have gone unchecked for years, and having the FDA leadership focused on fixing what’s broken is the first, very important step needed.

Matthew Buttell

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FDA told to investigate digital marketers | Deal agreed to fast-track new drugs | FDA review of GSK's Avandia continues

FDA told to investigate digital marketers

Thu, 04 Mar 2010 16:06:00 +0000

The Center for Digital Democracy has urged the FDA to investigate how pharmaceutical companies are making use of digital marketing techniques, citing that the US consumer should be protected from "inappropriate and harmful use."

According to reports, the US Food and Drug Administration (FDA) must ensure that the health and safety of US consumers are not in jeopardy because of how the pharmaceutical and health marketers have embraced "potentially harmful [...] digital marketing applications" which have given the industry "unprecedented abilities to take advantages of consumers."

Re-evaluation

The concerns come from the non-profit Center for Digital Democracy (CDD) and continue to say that "direct-to-consumer digital marketing of pharmaceutical and health-related products requires the FDA to re-evaluate its standards for advertising practices, including what should be considered as truthful and non-misleading."

Claims from the CDD suggest that a digital marketing system which is designed to "more effectively tap into the concerns - and ultimately the anxieties - of those seeking health information" has emerged across pharmaceutical websites, so-called "unbranded" sites, popular social networking sites and interactive video channels. The CDD, however, are concerned that few people are aware that they are being identified or labeled on the internet while they search or access the information on specific conditions or concerns.

"Safeguards"

The group's warning to the FDA says that it is "essential" that the regulator establishes "safeguards" for internet-related promotion, especially considering that interactive online communication is growing and - according to analysts - is likely to become the dominant form of delivery for health information in the next few years.

Jeff Chester, the CDD's executive director, says that "during a two day hearings conducted by the FDA last November on these issues, pharmaceutical marketers had purposely painted a sanitised, storybook image of social media marketing. Missing was data and information related to the powerful capabilities of interactive marketing to promote relationships with specific brands, including its ability to foster what has been called consumer 'micro-persuasion'.

"We want the FDA to make some policies related to pharmaceutical marketing that reflect the distinct nature of interactive marketing," he continued, adding that the CDD had commended the FDA for sending out warning letters to 14 drugmakers in April last year relating to their "inappropriate" use of search marketing advertising.

Matthew Buttell

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Pfizer job cuts continue | Deal agreed to fast-track new drugs | FDA review of GSK's Avandia continues

Pfizer job cuts continue

Tue, 02 Mar 2010 16:08:00 +0000

Global pharmaceutical giant Pfizer laid off 201 employees at the end of last week, as the company moved to close three local facilities and reduce staff at a fourth manufacturing plant.

The latest round of layoffs were confirmed by David Champagne, managing director of the NY-based Rouses Point manufacturing facility, yesterday. The layoffs involved 115 union employees at the Rouses Pointfacility and 86 union and management workers at the Chazy research facility, also located in New York.

"It's a tough decision, of course," said Champagne yesterday. "We're trying to make this as easy for our colleagues and people as possible." Champagne added that the last work day for an additional 85 management employees in Rouses Point will be 12 March.

Cutting back

Pfizer, the world's biggest pharmaceutical company, announced last November that it would be closing the Chazy, Plattsburgh and Rouses Point chemical-development facilities. For the manufacturing plant at Rouses Point, a reduction in the number of workers was also announced.

Reports suggest that once the process is complete, about 645 employees will have lost their jobs. In fact, according to Champagne, the ongoing monthly layoffs at the Chazy facility will continue, while the proposed layoffs at chemical development are not expected to start until at least the third quarter of 2010.

Disappointing

After yesterday's announcement, Rouses Point Mayor George Rivers said it's disappointing to see hard-working employees lose their jobs. "Its sad because still can't figure out why they [Pfizer] want to do it. Those are dedicated employees. I wish I had the magic answer."

January saw Pfizer extending its lease of the Rouses Point facility from Akrimax Pharmaceuticals until the end of 2010. It has two additional six-month options that could run through the end of 2011.

Matthew Buttell

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FDA deal to fast-track new drugs

Mon, 01 Mar 2010 17:49:00 +0000

A new partnership between the FDA and the NIH aimed at speeding up public access to innovative medicines have been welcomed by US industry leaders.

According to reports, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will work together to develop and implement new tools for regulatory science, which they believe has fallen behind developments in translational science.

FDA Commissioner Margaret Hamburg briefed the press about the first-of-its kind partnership this morning, saying that "[the industry] has allowed the arm of regulatory science to become weak and underdeveloped". She warned that, "unless this is corrected, we will row in circles."

Collaboration

The Pharma Times reports that the initiative is the brainchild of both Dr. Hamburg and NIH director Francis Collins, who will set up a new Joint NIH-FDA Leadership Council, which they will co-chair. According to their outlining of the partnership, the Council will spearhead collaborative work on important public health issues and work to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process.

Future-proofing

Grants equaling as much as $6.75 million will be made available over the next 18 months for projects that will be targeted at improving regulatory service. In addition, both the FDA and the NIH will hold a public meeting in the spring in an effort to collaborate on ideas about how the two agencies can work better together in the future.

Dr. Collins told the briefing that while the NIH and the FDA have been partners in many initiatives for more than two decades, this collaboration is the first of its kind and "will use the NIH's breadth of experience as a leader in biomedical sciences to help make the translation of biomedical discoveries into effective treatments as seamless as possible."

Matthew Buttell

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FDA review of GSK's Avandia continues | New reform plan wants $10bn from drug makers

FDA review of GSK's Avandia continues

Wed, 24 Feb 2010 08:16:00 +0000

The FDA has announced it will continue its review of the GSK's diabetes drug Avandia, saying it will not be rushed into any action. In what is proving to be a tough week for GSK, the move comes just days after the FDA included the company's blockbuster drug Advair as one of four asthma treatments that should be used less often by patients.

On Monday we reported that the pharmaceutical company had been battling to defend its asthma drug Advair after the US Food and Drug Administration (FDA) had announced that long-acting beta agonists (LABAs) ould never be used alone in the treatment of asthma. at the end of last week, the FDA ordered that manufacturers now include a warning on product labels, giving manufacturers just 30 days to respond to the proposed changes.

Now, while they are already fighting this - having been among the first of drug makers to speak out against the changes - the agency has today issued a statement after two US senators - Max Baucus and Chuck Grassley - released details a Senate Finance committee report based on a two-year inquiry of GSK's diabetes treatment Avandia (rosiglitazone).

According to the statement, the committee report was prompted by the publication of a study in the New England Journal of Medicine in May 2007, which warned of the possible cardiovascular risk of the drug. In addition, the report contains a memo from two FDA drug safety officals who recommend that Avandia be withdrawn from the market as they believe it is more dangerous than Takeda's rival treatment Actos.

Warning

Already, Avandia carries a boxed warning which which states that rosiglitazone in patients with established Class III or IV heart failure is contraindicated and is not recommended in patients with symptomatic heart failure.

However, while the senators have attacked the FDA for not making changes, the agency says it is happy for the time-being. Instead the FDA has announced that it has been following a number of observational studies, and will present "the totality of new and existing cardiovascular safety data" on Avandia at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

In the meantime, GSK is standing firmly behind the drug, stating that "the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk".

Matthew Buttell

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Weekend round-up | New reform plan wants $10bn from drug makers | GSK and XenoPort receive Complete Response Letter

New reform plan wants $10bn from drug makers

Tue, 23 Feb 2010 16:36:00 +0000

President Barack Obama's plans for healthcare reform have been reignited today with the unveiling of a newly revised proposal that would cost $950 billion over the next decade. It would also secure a further $10 billion for the pharmaceutical industry, which comes on top of the $80 billion the have already pledged for the 10 years beginning next year.

The unveiling of Obama's new plan, which comes ahead of the bipartisan healthcare summit that will be held on Thursday (25 February), is of particular significance to drug makers because it would require them to pay $10 billion in the form of fees on brand-name drugs. Though this would not begin until 2011, the fees would be used to help pay for the Medicare prescription drug benefit, completely closing the programme’s “donut hole” coverage gap which occurs when an enrollee’s annual drugs bill reaches $2830, after which they have to pay their costs out-of-pocket until their annual spending hits $4550.

The proposal

The renewed proposal, which tracks closely with the Senate's already-passed bill, "builds off the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as well as by incorporating Republican provisions that strengthen the proposal," said the White House in a statement.

The President's Proposal would end the "collusion" of brand-name drug makers paying generics producers to keep their cheaper copycat versions off the market. This is because these so-called "pay for delay" deals which "limit or forgo research, development, marketing, manufacturing or sales of the generic drug" would be prohibited, except in cases where the companies were able to prove that their settlement could "outweigh the anti-competitive effects of the agreement."

However, Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA) said the industry group was "deeply disappointed" at the proposed ban on settlements of generic patent challenges.

The President's plan would also extend discounts on drugs to hospitals and communities that serve low-income patients, and establish a new pathway to create generic versions of biological products "so that Americans have access to effective, lower-cost alternatives."

Matthew Buttell

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Weekend round-up | Big Pharma researcher fakes study

Weekend round-up

Mon, 22 Feb 2010 13:40:00 +0000

Both drug approvals and restrictions by the FDA, alongside reports of a renewed, more targeted focus on "pharmerging" markets have impacted the pharmaceutical industry over the weekend, beginning what could be a interesting week for the sector.

Since Friday, Global pharmaceutical giant GlaxoSmithKline (GSK) has been busy defending their blockbuster drug Advair after the US Food and Drug Administration (FDA) included the drug as one of four asthma treatments that they believe should be used less often.

The FDA warned that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma and have now ordered that manufacturers include a warning on product labels. Following their announcement at the end of last week, the drug makers now have just 30 days to agree to the label changes or provide evidence as to why they are not warranted. In response, GSK have already made a case apposing the label changes.

According to a statement released by GSK at the weekend: "There is no evidence from more than 10 years of data [...] that suggest that Advair is associated with an increased risk of asthma-related death, hospitalization or other serious respiratory-related outcomes in any age group."

However, the issue remains of particular concern to GSK given than Advair is still such a big earner. Fourth-quarter sale reached US$2.11 billion compared with rival AstraZeneca's same period sales for Symbicort only reaching US$1 billion.

Rituxan approved in US

But while GSK battle their issues, Roche and Biogen Idec have been celebrating as their blockbuster Rituxan receives yet another approval from the FDA, this time for the most common form of adult leukaemia.

According to reports from Friday, the approval is for Rituxan (rituximab) in combination with the chemotherapy regime fludarabine and cyclophosphamide (FC) for people with previously untreated as well as treated CD20-positive chronic lymphocytic leukaemia (CLL).

The approval is particularly noteworthy when looking at data from the American Cancer Society, which says there are nearly 90,000 people in the USA living with CLL, accounting for one-third of all leukemia cases. Last year, more than 15,000 new cases were expected to be diagnosed in the country.

Rituxan is also indicated for rheumatoid arthritis and had sales of almost US$6 billion last year and this latest approval can only help boost this figure further.

Concerns over liver trial

Leading specialty pharmaceutical company Salix Pharmaceuticals saw a decline in shares on Friday after the FDA cited concerns with its clinical trials looking at a new use of its diarrhea drug Xifaxan to treat a liver disorder.

According to a memo released on Friday, while results from a single clinical trial look promising, the results are hard to interpret. Possible liver side effects, including two deaths, are also a concern. The memo comes ahead of a public meeting to be held tomorrow.

The specialty pharmaceutical company is seeking expanded FDA approval of its Xifaxan diarrhea drug as a maintenance treatment for hepatic encephalopathy patients in remission. However the FDA said while the trial's "outcome on its face is persuasive, even for a single trial," the method used to assess the results "requires a subjective assessment and depends on clinician judgment."

According to FDA analysis, the company also "did not gather follow-up data on patients who developed adverse events."

The release of the data saw shares fall as much as 14 percent on Friday, though they have since improved. Tomorrow an FDA panel of outside experts will weigh whether to recommend wider approval.

Focus on Indian market

Big Pharma are reportedly moving to India with greater force, that's according to reports from the weekend. Sujay Shetty, associate director of professional services firm PricewaterhouseCoopers (PwC), detailed how "the domestic pharmaceutical landscape will rapidly change after the next two to three years, with multinationals gaining significant clout.

"In the next three years, Indian drug makers will continue playing a dominant role, but it will change after that," he warned.

Currently, according to regional data, Indian companies hold a 75 percent share in the domestic market, while the rest is held by multinationals, In the next five years this figure is expected to change, with the share of both foreign and Indian companies in the domestic market set to become more or less equal.

Big pharma are already growing a significant presence in the region, with Novartis having already introduced the Arogya Parivar model, which aims at ensuring availability of products at same prices but with different pack sizes; Eli Lilly, offering a project with the Self-Employed Women’s Association (Sewa) in Ahmedabad to educate people on tuberculosis and encourage them to take treatment; and sanofi-aventis introducing the initiative "Prayas", aimed at boosting generic drug sales in towns and rural India.

Matthew Buttell

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Big Pharma researcher fakes study | GSK and XenoPort | Who influenced WHO?

Big Pharma researcher fakes study

Fri, 19 Feb 2010 15:46:00 +0000

Reports pertaining to what could be the largest research fraud in medical history are beginning to surface today. In fact, according to mainstream media reports, a former member of Pfizer's speakers' bureau has agreed to plead guilty to faking literally hundreds of research studies published in medical journals in 2005.

The scandal relates to Dr. Scott Reuben who reportedly accepted a massive grant of $75,000 from Pfizer to study the drug Celebrex in 2005. While his research was initially published in a medical journal, it has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery.

However, evidence now suggests that Reuben never actually enrolled any patients in the survey and, according to reports, faked the entire study instead. What's more, it is believed that this data wasn't the first faked study by Reuben, with additional evidence from the Wall Street Journal suggesting he also faked study data on Bextra and Vioxx drugs.

Retraction

As a result of the faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 "scientific" papers authored by Reuben. In addition, The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

Dr. Reuben, meanwhile, is reported to have now signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

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GSK and XenoPort receive Complete Response Letter | Abbott continues fight against HIV | Who influenced WHO?

GSK and XenoPort receive Complete Response Letter

Fri, 19 Feb 2010 13:56:00 +0000

US-based biopharmaceutical company XenoPort, along with leading pharmaceutical company GlaxoSmithKline, received a Complete Response letter from the US Food and Drug Administration (FDA) on Wednesday regarding the New Drug Application (NDA) for Horizant (gabapentin enacarbil) Extended-Release Tablets.

The drug, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS), had applied for an NDA on 9 January 2009, but after reviewing the application the FDA have no issued a Complete Response letter.

This notice is issued by the FDA's Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. According to reports from Wednesday, GSK and XenoPort are currently evaluating the Complete Response letter, in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time.

Next steps

The FDA say that while it acknowledges that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, it concluded that the seriousness and severity of refractory epilepsy justified the potential risks. As such, GSK and XenoPort are now looking to assess the appropriate next steps through communication with FDA.

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Abbott continues fight against HIV | Gates pledges $10 billion

Abbott continues fight against HIV

Mon, 15 Feb 2010 15:17:00 +0000

Abbott has today announced FDA approval of a new tablet formulation of their antiretroviral medication Norvir. According to reports, the move will help Norvir - which is used in combination with other medications to treat HIV - to boost the fight against the disease.

The new tablets, which can be stored at room temperature and does not require refrigeration, will hopefully make treatment more convenient for patients. According to reports, while the new tablet and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir, and the rate the drug is absorbed is different, Abbott say there is no requirement for dosage change. What's more, all forms of Norvir, including the soft-gel capsule and liquid form, will remain available in the US.

According to Scott Brun, MD, divisional vice president, infectious disease development, Global Pharmaceutical Research and Development at Abbott, "Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV.

"Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."

Heat stability

Under Abbott's Meltrex technology, a proprietary melt-extrusion process, the final Norvir tablet formulation is more heat stable than existing treatments - meaning it does not need to remain refrigerated.

What's more, scientists at Abbott are confident that the heat-stable tablet formulation may allow patients greater flexibility to store and carry their medication with them.

Abbott's contribution to the fight against HIV/AIDS through the development of innovative tests and medicines have been well-documented over the last two decades or so. Notable contributions include:

The first licensed test to detect HIV antibodies in the blood, developed by Abbott in 1985 The company remains a leader in HIV diagnostics today.
In 1992, Abbott was the first company to receive FDA approval for an HIV diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply.
In 2000, Abbott received FDA accelerated approval for Kaletra.
In 2005, the tablet form of Kaletra received FDA approval.
In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully-automated blood screening test for HIV-1/HIV-2.

Matthew Buttell

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Who influenced WHO?

Thu, 04 Feb 2010 14:14:00 +0000

Is it better to overestimate the threat of a virus and spend millions on vaccines that may not be needed, or make a misjudgment in the other direction and cause millions of unnecessary deaths?

In April of last year, the World Health Organization (WHO) was informed of human infections caused by a new H1N1 virus. The report was classified as being of ‘immediate concern' because the genes contained in the virus were from animal influenza viruses, establishing that the virus was very different from the usual seasonal human influenza viruses.

On 11 June 2009, WHO announced that the virus would now be classed as a pandemic, because the virus had spread through 120 countries. It was predicted that the H1N1 virus would affect billions of people, and kill thousands. To date, there have been more than 14,000 laboratory-confirmed deaths worldwide.

Media speculation

In recent months, however, there has been speculation that due to WHO's ties with the pharmaceutical industry, the extent of H1N1 was exaggerated. It has been suggested that there was no need for WHO to call the virus a pandemic, an action that resulted in many countries changing their health priorities to accommodate the thousands of patient that were expected as a result. This, in turn, prompted governments to spend millions on contracts with drug companies to procure large quantities of H1N1 vaccine.

View more presentations from GDS International.

But, as argued by Dr. Keiji Fukuda, Special Advisor on Pandemic Influenza to the Director-General of WHO, "The H1N1 pandemic is not the same as seasonal influenza and differs in major respects. Large outbreaks occurred outside the usual season for influenza. The virus caused a striking and unusual pattern of severe illness and deaths in younger people, with many deaths caused by viral pneumonia: an especially aggressive form of the condition - and this pattern is not typically seen during seasonal influenza." Fukuda's arguments came on behalf of WHO at the Council of Europe hearing, The handling of the H1N1 pandemic: more transparency needed?, held last week.

Ultimately, WHO's collaborations with the industry provide better access to high-quality and affordable medicines, vaccines and diagnostics. Medical interventions, including antiviral drugs, vaccines and diagnostic tests, have long been recognized for their role in mitigating the health impact of an influenza pandemic. In fact, WHO itself states that "pharmaceutical companies play an essential role in this regard and WHO has engaged with them to pursue its public health objectives."

As such, in responding to the pandemic, WHO drew on advice from a standing body of experts, the Strategic Advisory Group of Experts on Immunization (SAGE), which advises WHO on vaccine use. Members of SAGE are likewise required to declare all professional and financial interests, including funding received from pharmaceutical companies or consultancies or other forms of professional engagement with pharmaceutical companies. The names and affiliations of members of SAGE and of SAGE working groups are published on the WHO website, together with meeting reports and declarations of interest submitted by the experts.

Profits

Yet there can be no denying that the pharmaceutical industry has seen a rise in profits as a direct result of the H1N1 pandemic and the resulting demand for vaccines. CSL Limited saw its profits rise 63 percent above 2008 levels by June 2009, while GlaxoSmithKline had benefited from a 30 percent jump by the third quarter. Roche, maker of the preventative drug Tamiflu, enjoyed a 12-fold leap in profits from the second quarter of 2008 to the same period in 2009.

What's more, and perhaps most critically, at the hearing Dr. Wolfgang Wodarg, a medical expert specializing in epidemiology and the former Chair of the PACE Sub-committee on Health, stated, "WHO basically held the trigger for the pandemic preparedness plans; they had a key role to play in deciding on the pandemic. Around 18 billion dollars was spent on this worldwide."

There is some debate over whether this is an issue of blame. At the hearing, and speaking on behalf of the pharmaceutical industry, was Dr Luc Hessel from the European Vaccine Manufacturers, who said, "The vaccine industry merely did what it was asked to do. The industry's role is to produce safe vaccines in a timely manner and respond to governments' requests. It is governed by stringent international health regulations and rigorous safeguards against conflict of interest. Decision-making regarding vaccine needs can only be based on the best available data at the time."

Nonetheless, swine flu has ended up being one of the most expensive public health crises ever, as - in the midst of a global recession - governments spent millions on vaccines that now may not be needed. And because of this, drug companies are reaping the benefits.

Far from over

Despite the fact that WHO says the pandemic isn't over yet, with more infections - and deaths - still to come, many nations are nevertheless attempting to cancel pending orders for H1N1 vaccines. France, for instance, which had ordered 90 million doses of the vaccine, more than was needed to inoculate its entire population of 60 million, has so far used only five million doses and now wants to cancel 50 million and sell the rest. Similarly, the Netherlands has a 19 million-dose order on sale to other countries, while Germany is in talks with manufacturers to halve its order of 50 million doses and sell off millions of others.

Switzerland, Spain and Britain are also considering giving away or selling the millions of doses that they have received or have on order, while the US, which has so far only distributed 160 million of the 251 million doses it purchased to doctors, hospitals and other healthcare providers, has yet to make a decision on whether it will have an overflow and what it will do with any surplus.

The main reason for the extra vaccine is simply that demand fell far short of what was originally expected. And now, after governments have spent billions of dollars on vaccines that are seemingly not needed, some politicians and health professionals are looking for someone to hold accountable.

Dr. Fukuda, however, argues that, "WHO is confident of the scientific validity of its recommendations. The labeling of the pandemic as ‘fake' is to ignore recent history and science and to trivialize the deaths of over 14,000 people and the many additional serious illnesses experienced by others."

He certainly has a point: while the number of cases might be declining, the fact remains that more 14,000 people died as a result of the virus. In the US alone, initial estimates put the projected death toll at 90,000, while in the UK the figure was expected to be 50,000. While the actual figures haven't reached these numbers, the effects of swine flu are still very real.

Was the seriousness of the swine flu pandemic exaggerated? Perhaps, but it would be wrong to jump to the conclusion that this was done to line the pockets of the world's drug-makers. On the contrary, the speedy development and delivery of vaccines could be one of the main reasons that the pandemic hasn't reached the dizzying heights of infection that were initially expected. After all, a pandemic remains a pandemic whether it results in 14,000 deaths or - like the Spanish Flu in 1918 - 50 million.

Gates pledges $10 billion

Mon, 01 Feb 2010 16:31:00 +0000

At last week's World Economic Forum in Davos, Switzerland, revered business tycoon and founder of computer software giant Microsoft, Bill Gates, announced with his wife Melinda, that they will commit $10 billion over the next decade to help research, develop and deliver vaccines for the world’s poorest countries.

According to Mrs. Gates, who announced the initiative last Friday, the vaccines are now the "number one priority" of the Gates Foundation because of the "incredible impact" they have on children’s lives. Bill Gates added that the next 10 years must be defined as "the decade of vaccines."

Prevention better than cure

The boost comes after a model (used by the Foundation and) developed by a consortium led by the Institute of International Programs at the Johns Hopkins Bloomberg School of Public Health stated that significantly scaling up the delivery of vaccines in developing countries could prevent the deaths of some 7.6 million children.

Of course, that would take some major ramping up of vaccines, to as much as 90 percent coverages, but the Gateses are confident that this is achievable. In fact, Mr. and Mrs. Gates hope that their pledge, which comes on top of the $4.5 billion the Foundation has already committed to this area, will help this become a reality.

In addition, the report also suggests that 1.1 million more children could be saved with the rapid introduction of a malaria vaccine beginning in 2014, which brings the total number of potential lives saved to 8.7 million. This adds even more clarity to Bill Gates' need to call this decade The Decade of the Vaccine - given that the introduction of even more vaccines by the global pharmaceutical industry could save even more lives

The business of vaccines

In fact, much of the drive behind the pledge has been driven by the remarkable progress made by vaccines in recent years. According to reports, Mr and Mrs Gates said their pledge "has been inspired" by global vaccination rates, which have now reached all-time highs from years of decline in the 1990s.

They also noted that many of the recent advances in vaccine development and delivery have been driven by public-private partnerships such as the GAVI Alliance (Global Alliance for Vaccines and Immunisation) and the Rotavirus Vaccine Program at the Programme for Appropriate Technology in Health (PATH), which coordinates the resources and expertise of vaccine companies, donors, the United Nations’ Children’s Fund (UNICEF), the World Health Organization (WHO), the World Bank and developing countries. These partnerships are "transforming the business of vaccines," said Mr Gates.

Malaria breakthrough

Mon, 25 Jan 2010 16:12:00 +0000

Scientists across the globe have long hunted for a vaccine against malaria - a disease that claims roughly one million lives each year. But last week, after decades of searching, the creation of a malaria vaccine began to look more and more likely.

The first good piece of news relating to the wiping out of malaria came after UK-based pharmaceutical giant GlaxoSmithKline (GSK) announced it would take the significantly unprecedented step of sharing its scientific data and laboratories to help fight the good fight against tropical countries.

According to reports from the end of last week, Andrew Witty, Chief Executive of the firm and the driving force behind the initiative, the drug company has a "genuine appetite to change the landscape of healthcare for the world's poorest people."

Breakthrough

Meanwhile, in separate reports, researchers in Australia said a group of proteins produced in the human immune system - when infected with malaria - could help lead to the creation of a malaria vaccine.

This news - which broke just several hours after GSK's announcement - came from Melbourne's Walter and Eliza Hall Institute and has reportedly left scientists optimistic that a vaccine can be created because people living in malaria hotspots eventually build up some immunity against the disease.

Lack of resources

However, official estimates show that, while Africa carries roughly 70 percent of the number of worldwide cases for malaria, it receives just three percent of global healthcare resources.

For GSK's Witty, long periods of working in the continent have reportedly made this issue "very personal" to him, at least according to the British press.

As such, GSK, the world's third-largest drug company, will freely release 13,500 of its compounds, via a website, that it believes have the potential to be developed into new malaria treatments.

The plan will also see the firm open up one of its labs in Tres Cantos, Spain, for non-GSK scientists to use to investigate treatments for other tropical diseases. According to reports, the so-called "Open Lab" will offer enough space for 60 scientists to work on treatments and GSK will provide $8 million of funding for their research.

Meanwhile, at the Australian Institute, the research - which scoured the results of international studies to find antigens (substances that provoke an immune response in the body) to find a potential weapon against malaria - has found a protein produced by malaria parasites that does just that.

According to the researchers, a successful vaccine would stimulate the body's defenses to stop the malaria parasite. Dr. James Beeson writes, "The basis of the vaccine would be trying to speed up what the immune system does naturally in areas where malaria occurs.

"What the vaccine would aim to do is achieve that in a much more rapid process, rather than losing many people's lives and people experiencing a lot of illness before they develop immunity."

Reinvestment

The good news continued at the end of last week after GSK announced it will adopt not-for-profit pricing on its potential malaria vaccine - which is currently the world's leading candidate for a prevention of the disease - and reinvest the small returns in the research of tropical disease treatments.

According to a spokesman from leading emergency aid society the Red Cross: "Any research which reduces the burden of this disease has to be welcomed."

However, the Australian researchers, though encouraged by their findings, did note that more clinical experiments are needed and a vaccine could be at least 10 years away.

Take a look at the accompanying infographic, which breaks down the facts and figures behind the disease and highlights the need for such a solid investment in vaccine research.

Novartis: $2.5 million to Haiti victims

Tue, 19 Jan 2010 13:16:00 +0000

On 12 January, Haiti was rocked by the largest earthquake ever recorded in the area. The incident has sparked the call for emergency aid across the world, and now, thanks to Novartis, the pharmaceutical industry is getting on board too.

According to reports, global pharmaceutical firm Novartis is, through its local organizations in countries throughout the region, set to provide the equivalent of over $2.5 million in immediate emergency aid for victims of the disaster.

Reports show that this support will include both direct financial aid to relief agencies working in Haiti, as well as donations of essential medicines, including antibiotic and pain relieving drugs.

Conscious effort

The move by Novartis is being viewed by some skeptics as little more than lip service to the latest natural disaster that has rocked our plant, with some suggesting that the move is merely designed to demonstrate that Big Pharma has a heart and isn't all about profits. But, according to Dr. Daniel Vasella, Chairman and CEO of Novartis, the support from the pharmaceutical industry is, in reality, much more genuine.

According to a recent statement, he said, "It was with dismay that we learned about the destructive force of the earthquake in Haiti, which has brought such immense suffering to that nation and its people."

"I would like to express our deepest sympathy for all the people affected and also to assure them of our support. Our experience of providing support in the wake of natural disasters has proven successful, ensuring that we can get aid to the people in need fast and efficiently."

In addition to this support, Novartis employees across the globe are being encouraged to make cash contributions to internationally and nationally recognized relief organizations in support of the victims of the earthquake. These donations, the company says, will then be matched.

What's more, Novartis has said it will now work with local authorities and aid organizations to identify where assistance can be provided on a long-term basis to ensure that there is sustainable support for those in the region.

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J&J sued for alleged kickbacks

Mon, 18 Jan 2010 13:52:00 +0000

Leading pharmaceutical firm Johnson & Johnson are reportedly the latest firm accused of paying kickbacks to the pharmaceutical supply chain. This time to boost sales of its drugs in nursing homes across the US.

Reports first surfaced on Saturday when, among other reputable sources, the Washington Post reported that the US-based medical giant had paid "tens of millions of dollars" in kickbacks, resulting in the US Department of Justice (DoJ) filing a lawsuit against the firm at the end of last week.

By Sunday, the DoJ had confirmed that it had filed a False Claims Act complaint against J&J. The DoJ say that the firm paid Omnicare, the US's largest pharmacy, to purchase and recommend the firm's drugs, including the antipsychotic drug Risperdal (risperidone), for use in nursing homes between 1999 and 2004. And, according to reports in the Pharma Times, the complaint says that Johnson & Johnson understood that Omnicare's pharmacists reviewed nursing home patients' charts "at least monthly and made recommendations to physicians on what drugs should be prescribed."

'Knowingly accepted'

Reports in the media suggest the US government believe Johnson & Johnson knowingly accepted that physicians followed Omnicare recommendations "more than 80 percent of the time" and therefore alleged that Johnson & Johnson were knowingly manipulating the market to boost revenue. According to the complaint, J&J viewed such pharmacists as an "extension of [its] sales force."

However, reports also suggest that Johnson & Johnson doesn't believe that it acted wrongly. According to a statement from the firm, the company "believes that airing the facts will confirm our conduct, including rebating programmes like those the government now challenges, was lawful and appropriate".

Ultimately, however, the firm's weekend only got worse, after reports also surfaced pertaining to its consumer healthcare division McNeil, which announced it was recalling 53 million bottles of over-the-counter products from the Americas, the United Arab Emirates and Fiji. Reports suggest that the recalled products have been pulled as part of an "investigation of consumers reports of an unusual moldy, musty, or mildew-like odour."

J&J recall numerous products

Fri, 15 Jan 2010 16:35:00 +0000

Pharmaceutical giant Johnson & Johnson is facing a new scandal as its consumer division said it was recalling more than 500 products that are available over-the-counter, including brands such as Tylenol, Motrin and Rolaids.

The recall was issued after reports of an unusual odor emanating from the products. It is similar to the issue that saw a mass Tylenol recall last year, damaging the product's reputation.

The odor has been described as a "unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events." In a statement, J&J stated that some consumers had experienced nausea, stomach pain, vomiting and diarrhea.

The recall, that will involve calling back products from all over the world including the United Arab Emirates and Fiji, will also involve Benadryl allergy drug and St. Joseph's Aspirin.

Cause of smell revealed

According to J&J's McNeil Consumer Healthcare division, the smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA), which can result from the breaking down of a chemical found in wood pallets and other packaging and transport materials.

Speaking to Reuters, a company spokeswoman said that while they were unsure how the chemical could have penetrated the packaging of the numerous products, "no serious events have been documented in the medical literature."

J&J, which also sells prescription drugs and medical devices, is one of the world's largest consumer healthcare companies, providing common household products such as Band-Aids, shampoo and Tylenol.

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Sir McClay, Head of Almac, dies

Wed, 13 Jan 2010 14:42:00 +0000

The head of Almac, Sir Allen McClay, has died in the United States aged 80.

Sir Allen, who qualified as a pharmacist in 1953, established his first business, Galen, in 1968 and made it one of the world's leading pharmaceutical and bio-tech company.

The company's success made Sir Allen a multi-millionaire and one of Northern Ireland's richest men. When he floated the company on the London and Dublin stock-markets in 1997, he established the first GBP£1 billion company in Northern Ireland and secured his personal fortune.

When he retired as President of Galen Holdings, which later changed its name to Warner Chilcott, in 2001 he established a new company - Almac.

Almac quickly established itself as a leading pharmaceutical firm and employs thousands of people in the pharmaceutical industry.

The Almac Group

Based in Craigavon, County Armagh with other facilities in Scotland, England and the United States, Almac provides integrated drug development services, research and manufacturing, to about 600 clients.

The company has set up several joint efforts with clients, including aiding Hewlett-Packard by investing in test applications software that it felt would shorten the amount of time a drug would spend in clinical trials.

Sir McClay was knighted in 2005 and for a man of his wealth, was a very generous philanthropist. He set up the McClay Foundation to unite industry and academia, which has a turnover of GBP£167 million. He also personally donated GBP£20 million to Queen's University in Belfast.

Ironically, for all his success in the pharmaceutical industry, Sir McClay often described himself as "one of the world's worst pharmacists."

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Regulators cancel Lilly review

Wed, 06 Jan 2010 15:03:00 +0000

US regulators have reportedly cancelled a review meeting set to decide upon proposed new indication for Eli Lilly's blockbuster antidepressant Cymbalta, according to their website.

According to a notice on their website, the US Food and Drug Administration (FDA) has now cancelled the review meeting that was due to take place on 29 January in light of "new information", in hope that a delay in hosting the review will allow such new information to prove to be relevant to the benefit risk balance for the proposed new indication.

Evaluation

However, the FDA also maintains that it intends to "continue evaluating the application" and is likely to announce future meeting dates for the FDA's Anesthetic and Life Support Drugs Advisory Committee to reconvene and consider whether Cymbalta (duloxetine) should be recommended for approval for the treatment of chronic pain.

The drug is already approved for depression, anxiety, diabetic nerve pain and fibromyalgia, and had third-quarter sales of $790.2 million, up 10 percent.

However, the company had already withdrawn its supplemental New Drug Application for Cymbalta for chronic pain in November 2008, sparking concern over the FDA's ruling. Eli Lilly resubmitted the file in June 2009.

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H1N1 vaccines recalled

Wed, 16 Dec 2009 16:34:00 +0000

Reports show that 800,000 doses of H1N1 vaccine have been recalled by manufacturer Sanofi-Aventis due to the influenza vaccine losing its potency since it was shipped from the factory.

Thankfully, the reports seem to suggest that the recall isn't safety-related, but is instead part of a routine "quality assurance program". According to Dr. Anne Schuchat, who is director of the Centers for Disease Control and Prevention's (CDC) National Center for Immunization and Respiratory Diseases, "There are now 94.6 million doses of vaccine available, so this is not as big a deal as it might have been earlier". She continued to emphasize that the issue presented no safety concerns.

Total recall

The recall, which affects doses of re-filled syringes made for children ages six months to 35 months, first came to light yesterday. According to reports in the New York Times, Sanofi-Aventis voluntarily recalled 800,000 doses of low-dose, thimerosal-free vaccine; though, since most of the vaccine was released a month ago, it presumably has already been used. As such, the recall is really intended to alert doctors to return any supplies they have left.

Despite concerns over "low potency", Schuchat did comment that the CDC believes that those children who already got the vaccine are fully protected, assuming they got the two shots that were recommended for that age bracket. "We don't think parents need to contact their doctors," she added.

Thimerosal-free

The low potency concerns are related to the lack of thimersoal in the product. Thimerosal, a mercury-based preservative that federal health officials consider harmless, has been criticised by some parents on the basis that anti-vaccine activists blame it for autism and other ills. As such, the ingredient was left out of vaccines intended for children under two years old, largely in an effort to quell such concerns.

However, low doses in multidose vials, which contain thimerosal to kill any bacteria or fungus accidentally introduced by needles piercing the rubber stopper, remain available for infants.

Two-year-olds, meanwhile, can use the nasal spray vaccine, which contains no thimerosal.

Reports also show that Sanofi, which is one of five vaccine manufacturers whose products are approved in the United States, routinely check their products for potency at regular intervals; none of the others manufacturers are yet to report any problems.

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