One of the more popular theories seeking to explain the Feds' seemingly inexplicable ban on medical pot goes like this: Neither the US government nor the pharmaceutical industry will allow for the use of medical marijuana because they can't patent it or profit from it.

It's an appealing theory, yet I've found it to be neither accurate nor persuasive. Here's why.

First, let me state the obvious. Big Pharma is busily applying for -- and has already received -- multiple patents for the medical properties of pot. These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain's endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper (pdf), "The endocannabinoid system as an emerging target of pharmacotherapy," which concluded, "The growing interest in the underlying science has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004." In other words, at the same time the American Medical Association is proclaiming that pot has no medical value, Big Pharma is in a frenzy to bring dozens of new, cannabis-based medicines to market.

Not all of these medicines will be synthetic pills either. Most notably, GW Pharmaceutical's oral marijuana spray, Sativex, is a patented standardized dose of natural cannabis extracts. (The extracts, primarily THC and the non-psychoactive, anxiolytic compound CBD, are taken directly from marijuana plants grown at an undisclosed, company warehouse.)

Does Big Pharma's sudden and growing interest in the research and development of pot-based medicines mean that the industry is proactively supporting marijuana prohibition? Not if they know what's good for them. Let me explain.

First, any and all cannabis-based medicines must be granted approval from federal regulatory bodies such as the US Food and Drug Administration -- a process that remains as much based on politics as it is on scientific merit. Chances are that a government that is unreasonably hostile toward the marijuana plant will also be unreasonably hostile toward sanctioning cannabis-based pharmaceuticals.

A recent example of this may be found in the Medicine and Health Products Regulatory Agency's recent denial of Sativex as a prescription drug in the United Kingdom. (Sativex's parent company, GW Pharmaceuticals, is based in London.) In recent years, British politicians have taken an atypically hard-line against the recreational use of marijuana -- culminating in Prime Minister Gordon Brown's declaration that today's pot is now of "lethal quality." (Shortly thereafter, Parliament elected to stiffen criminal penalties on the possession of the drug from a verbal warning to up to five years in jail.) In such an environment is it any wonder that British regulators have steadfastly refused to legalize a pot-based medicine, even one with an impeccable safety record like Sativex? Conversely, Canadian health regulators -- who take a much more liberal view toward the use of natural cannabis and oversee its distribution to authorized patients -- recently approved Sativex as a prescription drug.

Of course, gaining regulatory approval is only half the battle. The real hurdle for Big Pharma is finding customers for its product. Here again, a culture that is familiar with and educated to the use therapeutic cannabis is likely going to be far more open to the use of pot-based medicines than a population still stuck in the grip of "Reefer Madness."

Will those patients who already have first-hand experience with the use of medical pot switch to a cannabis-based pharmaceutical if one becomes legally available? Maybe not, but these individuals comprise only a fraction of the US population. Certainly many others will -- including many older patients who would never the desire to try or the access to obtain natural cannabis. Bottom line: regardless of whether pot is legal or not, cannabis-based pharmaceuticals will no doubt have a broad appeal.

But wouldn't the legal availability of pot encourage patients to use fewer pharmaceuticals overall? Perhaps, though likely not to any degree that adversely impacts Big Pharma's bottom line. Certainly most individuals in the Netherlands, Canada, and in California -- three regions where medical pot is both legal and easily accessible on the open market -- use prescription drugs, not cannabis for their ailments. Further, despite the availability of numerous legal healing herbs and traditional medicines such as Echinacea, Witch Hazel, and Eastern hemlock most Americans continue to turn to pharmaceutical preparations as their remedies of choice.

Should the advent of legal, alternative pot-based medicines ever warrant or justify the criminalization of patients who find superior relief from natural cannabis? Certainly not. But, as the private sector continues to move forward with research into the safety and efficacy of marijuana-based pharmaceuticals, it will become harder and harder for the government and law enforcement to maintain their absurd and illogical policy of total pot prohibition.

Of course, were it not for advocates having worked for four decades to legalize medical cannabis, it's unlikely that anyone -- most especially the pharmaceutical industry -- would be turning their attention toward the development and marketing of cannabis-based therapeutics. That said, I won't be holding my breath waiting for any royalty checks.

Oh yeah, and as for those who claim that the US government can't patent medical pot, check out the assignee for US Patent #6630507.

http://www.patentstorm.us/patents/6630507/fulltext.html

Note: While the the American Medical Association claims pot has no medical value, Big Pharma is busy getting patents for marijuana products.

Complete Title: Big Pharma Is in a Frenzy To Bring Cannabis-Based Medicines To Market

Paul Armentano is the senior policy analyst for the NORML Foundation in Washington, DC.

Source: AlterNet (US)

Website: http://www.alternet.org/

Heart trials for diabetes medicines? - The agency wants its Endocrinologic and Metabolic Drugs Advisory Committee to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large...more

Paxil and pregnancies - Much of the hoopla one reads about the controversial antidepressant concerns the risk of suicide and the extent to which the drugmaker disclosed - or did not disclose - meaningful clinical trial data...more

Doctors under the Influence?

Breathing easier at Merck and Schering? - Could it be? Are they getting a divorce over Vytorin? No, sorry to excite you. But the drugmakers are ending their respiratory joint venture and their eight-year effort to market a combination of their Claritin and Singulair medications, which are used to treat allergic rhinitis...more

Analyst takes up news space with BMS conjecture - The drugmaker looks increasingly attractive and a sale is a “distinct possibility,” according to Tim Anderson, a pharma analyst at Sanford Bernstein...more

Pharma's sinking reputation - The latest Harris Interactive poll that examines American attitudes toward corporate America offers a sobering view of and for the pharmaceutical industry. Only 26 percent of Americans view the industry favorably...more

Can't make this stuff up - A drug developed using nanotechnology and a fungus that contaminated a lab experiment may be broadly effective against a range of cancers, U.S. researchers reported on Sunday...more

Sweet home Alabama - A state court jury decided the two drugmakers defrauded Alabama in a long-running Medicaid drug pricing scheme and ordered them to pay more than $114 million in damages, the Associated Press reports...more

Pfizer rocking the CME funding world - In what may be a first, a drugmaker will still support continuing medical education courses at academic institutions, teaching hospitals and those supported by medical societies, but no longer directly support CME courses offered by for-profit medical-education and communication companies, Dow Jones reports...more

Xience (drug-eluting stent from Abbott) gets approval.

They do pass laws in D.C., after all - Earlier this year, the city became the first in the country to license sales reps, whose licenses can be revoked if their activities are deemed fraudulent. The bill was passed in hopes of enforcing good business practices on people who have undue influence over docs, and therefore patients...more

Since Ranbaxy was a minnow by global standards, its takeover was to be expected. Don't be surprised if the same happens to firms like Infosys.

Family patriarch Bhai Mohan Singh may well be turning in his grave, but the sale of the promoters' stake in Ranbaxy marks the end of an era for the company. For sure, the unexpected sale of a perceived star brand — which in the public eye was scaling new horizons — was a psychological shocker. More so since the acquirer is hardly known to the Indian investing public.

A part of the initial resentment could well be because of the new Japanese parentage and, in our Eurocentric mindsets, the Japanese are synonymous with only automobiles and consumer electronics. They have not made an indelible mark in any other industrial sphere.

But by design or otherwise, the sale did send out one big shrill message — that India Inc. is now truly ready for friendly takeovers. This will augur well for the stock markets and for the investment climate. The fact that the voluble Left parties and the trade unions have chosen not to voice their feelings on this high profile deal shows that they too have come of age.

A precursor of the shape of things to come was jarringly seen in early 2005 when the MNC, Holcim, in a friendly coup-de-grace, became India's largest cement manufacturer just like that, after it got its hands on ACC and Gujarat Ambuja in a swift $1 billion-plus deal. Cement however is perceived as a low-tech domestic commodity industry player, and the event quietly passed into the history books.

The management control of one of most India's best-known brand icons passing on to the Land of the Rising Sun is one part of the story. North India really does not boast of too many enduring homespun, private-sector brands of long standing, and thus the present ‘regime change' — in a manner of speaking — makes for an even more better pill, for some diehards.

The initial negative emotive fallout of the deal aside, this harks back to the 1980s when, in the initial flash of liberalisation, there was a small rash of takeovers of domestic enterprises including that of the media-savvy bottled drinks company owned by the eloquent Ramesh Chauhan (Chauhan's problems were unique — his bottlers fled pell mell to the Coke stable and he wisely exited).

The acquisition spree even provoked an emotional and uncharacteristic outburst from the aging legal luminary, the late Nani Palkhivala. More importantly, it triggered a flight of Indian business capital to safer havens abroad.

In the pre-liberalisation days, mergers and acquisitions were a strict no-no as promoters were sub-consciously prevented from exiting due to the then prevailing mindset — that the sale of one's business was an admittance of incompetence — and hence labelled a loser. If at all businesses did change hands, it was because of British interests selling out to their Indian counterparts, due to the nationalistic upsurge following the strict enforcement of FERA & MRTP, and the difficult operating conditions that big business had to contend with. The Union Carbide fiasco did little to add to the aura of MNC business.

But much water has flown under the Yamuna since then. Business evolution and the arrival of bulge bracket investors changed mindsets, aided by a slew of new business opportunities, with the sale of a few dotcom websites to Satyam for a king's ransom proving to be a major trigger. The government on its part contributed its mite by periodically reducing the number of industries reserved exclusively for the small-scale sector.

But, really, is the Ranbaxy sale such a big deal? The company is an MNC for sure, by virtue of its operations in several countries, but not really a pharmaceutical giant. It is dwarfed by its acquirer, and a mere pygmy when sized up against other MNC pharmas.

Ranbaxy is no Navaratna either, and is not India's IBM. For, it has no control of any proprietary technologies, having primarily mastered the science of forensics and reverse engineering of drugs on which patents have ceased to apply. The Singhs it would also appear had long been contemplating a clean exit. Thus their careful nurturing of other business ventures — hospitals, pharmacies and the booming financial services sector.

The acquirers have yet to speak there mind, but after burning close to $5 billion, they definitely have their plans all sewn up. Time will tell in which direction they point. But business operations are unlikely to undergo any change — as the market for Ranbaxy is still primarily India and a couple of other markets.

It is of course nice to note that MNCs finally see India as an emerging shopping opportunity — and nationalist sentiments have been kept at bay, partly due to the bonanza that will accrue to minority stakeholders who wish to encash, and the belief that the new owners will add to the brand equity of the target company.

The only other large friendly Japanese MNC acquisition of late that comes to mind was the sale of the privately-held Anchor Electricals to Panasonic. There are of course no unfriendly MNC bids to date. Rumours of one such on Hindalco turned out to be a mere rumour in the end.

But the ground appears to be clearing for unfriendly bids too. That could well mean that even such stars as Infosys and Satyam (which have diffused promoter holding) may well be among the first to feature in the crosshairs of prospective acquirers. If such a day dawns, minority stakeholders will be laughing all the way to the bank. Sadly enough, none of the Navaratna PSUs will ever be on the list — at least not in our lifetime.

NEW DELHI: Two manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and drug Administration (USFDA), the drug regulatory body in the US.

All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

According to sources, USFDA carried out inspections at Ranbaxy’s manufacturing plant at Dewas (Madhya Pradesh) and Batamandi (Himachal Pradesh) earlier this year. USFDA is learnt to have raised concerns over cross contamination at the Dewas plant.

Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.

A
A detailed questionnaire listing these points and inviting responses from Ranbaxy elicited the following summary response from the company spokesperson, “Our facilities are inspected by USFDA and other regulatory agencies on an ongoing basis.”

Ranbaxy addded, “All resulting comments are addressed by our technical teams who work to satisfy the authorities. We remain committed as always to supply highest-quality products to our customers in India and overseas.” A specific query about whether new products manufactured at Dewas and Batamandi could be exported to the US went unanswered by the spokesperson.

In an e-mail response to ET, an USFDA spokesperson said, “The inspections have concluded. The agency has nothing further to discuss.”

The US is Ranbaxy’s single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

Of course, Ranbaxy is not the only Indian company that has had a run in with USFDA. A few months ago, Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

This is not the first time the Gurgaon-based Ranbaxy has come under USFDA’s scrutiny either. In February last year, USFDA’s criminal branch conducted a search at the company’s New Jersey facility in the US for alleged document fraud and activities related to sub-standard product manufacturing.

In November last year, Ranbaxy voluntarily recalled 73 million pills of Gabapentin from the US retail market after discovering impurities outside the approved specification limit.

In 2006, USFDA had conducted investigations at the company’s Paonta Sahib plant. While the company said that it has provided the FDA with all the requisite information and data, it is yet to get a clean chit from the regulator.
Ranbaxy’s new owner Daiichi Sankyo is aware of the company’s issues with USFDA.

Daiichi Sankyo president and CEO Takashi Shoda had earlier told ET that it is conducting an independent due diligence on the issue. According to the company’s website, it has manufacturing facilities in 11 countries. Its Indian facilities meet the requirements of all regulatory agencies such as MCA-UK, MCC-South Africa, USFDA and TGA-Australia.

[via eyeonFDA]

Every depression, though, has its bright spot -- and the bright spot here happens to be anti-depressants. Last year, for the sixth year in a row, anti-depressants ranked as the No. 1 therapeutic class of dispensed prescriptions in the United States. Americans filled more that 232 million prescriptions -- to the tune of nearly $12 billion in revenues, according to a March report by IMS Health.

Who knew that 16% of women ages 20-44 take antidepressants? This fact comes from a recent report by Medco Health Solutions (MHS), the pharmacy benefit manager. Medco also disclosed that, for the first time, a majority of the insured population is taking prescription drugs to treat at least one chronic health problem.

Diving deeper into anti-depressants, we asked Express Scripts (ESRX), another pharmacy benefit manager, to tell us which Fortune 500 companies represent the biggest consumers in terms of employee prescriptions. No go. Nor would Express Scripts reveal which industries account for the highest consumption. But the company does report that among its members, antidepressant use increased 33% from 2000 to 2006.

That’s a healthy market for sure. Where in the United States is the anti-depressant business most vibrant? Utah ranks No. 1., followed by Kentucky, Maine, Arkansas and Louisiana (are Utahans replacing drinks with drugs? Utah ranks at the bottom in alcohol consumption.). The lowest usage, meanwhile, is in Illinois, Nevada, California, New Jersey and New York. You might guess where antidepressant consumption spiked in the past few years. Alabama and Louisiana. Lingering damage from Hurricane Katrina? - Jessica Shambora

The market is broken down into applications of branded prescription drugs, generic prescription drugs and over-the-counter (OTC) products. Of these, branded prescription drugs have the largest share of the market. Worth an estimated $525.1 billion in 2007, this segment is expected to grow to a value of $553.2 billion in 2008 and $741.5 billion by the end of 2013, for a CAGR of 6.0%.

The second largest segment, generic prescription drugs, will experience the highest growth rate over the study period. Worth $78.5 billion in 2007 and an estimated $88.7 billion in 2008, it will reach $151.4 billion by the end of 2013, for a CAGR of 11.3%.

The OTC segment was worth over $90.0 billion in 2007. It should increase to $95.7 billion in 2008 and reach $135.1 billion in 2013, for a CAGR of 7.1%.

Though the worldwide pharmaceutical industry remains one of the most profitable and stable industries, several variables are influencing fundamental changes in its structure including increasing examples of government-imposed price reductions in pharmaceutical prices, the increasing role of generic substitutes, and enhanced outsourcing, in-licensing, contract research and manufacturing activities.

Increased health awareness amongst patients and governments, changing world demographics, declining R&D productivity, worldwide compliance of general agreements on tariffs and trade (GATT) and trade related intellectual property rights (TRIPS), along with the emergence of e-pharmaceuticals also are reshaping the dynamic pharmaceuticals industry.¹

¹BCC Research

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The right to life is a fundamental Human Right . . . so is the right to access life-saving medicines . . .

Image: www.sciencemuseum.org.uk

First, I shall include a press release from the team of noble international life-savers, Médecins Sans Frontières (MSF or Doctors without Borders) below:

The Indian Network of People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), and the Lawyers’ Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by Glaxo Group Limited for Combivir, a fixed-dose combination of two AIDS drugs (zidovudine/lamivudine, or AZT/3TC). The opposition is based on technical and health grounds. If India grants a patent on this AIDS drug, it will set a precedent that will hamper access to affordable AIDS medicines worldwide.

“Affordable generic AIDS medicines have been one of the cornerstones of our ability to keep more people alive, including here in India where we began treating people with AIDS this year,” said Dr. Pehrolov Pehrson, of MSF’s treatment project in Manipur, where all patients on antiretrovirals receive generics produced in India. “Without a reliable supply of low cost AIDS drugs – made possible because medicines patents did not exist in India for many years – national governments and treatment providers alike will be faced with an uphill battle, and patients risk having vital treatment interrupted or priced out of their reach.”

Of the over 60,000 patients in nearly 30 countries in MSF projects, 84% receive generic AIDS medicines made in India. Over 90% of all patients using AZT/3TC in MSF projects are on generic versions of the drug. National treatment programmes in India, Burkina Faso, Mongolia, Central African Republic, Malawi, Peru, the Republic of Kyrgizstan, Cambodia, Ukraine and Swaziland heavily rely on generic AZT/3TC. The availability of affordable quality generic versions of Combivir (AZT/3TC) and other anti-retroviral medicines has allowed developing countries to put more people on treatment and thus extend their lives.

The Indian groups opposing the patent are arguing that Glaxo’s Combivir (AZT/3TC) is not a new invention but simply the combination of two existing drugs. They say the granting of such a patent risks increasing the cost of anti-retroviral treatment for many people living with HIV/AIDS, thereby further increasing the burden on developing countries already struggling to treat patients.

“Universal Access to AIDS medicines will remain an elusive goal if there isn’t a steady supply of affordable medicines. Decisions made by Indian patent offices are a question of life or death for people living with HIV/AIDS worldwide who rely on the availability of these drugs made in India,” said Ellen ‘t Hoen, Director of Policy Advocacy at MSF’s Campaign for Access to Essential Medicines.

Last year, India changed its patent law to comply with the World Trade Organization’s patent rules. Three weeks ago, India granted its first ever patent to Roche for a hepatitis C treatment.

However, the Indian Patent law allows oppositions to a patent application before it is granted. Indian cancer patients and generic drug manufacturers recently opposed a Novartis patent application for Gleevec (Imatinib Mesylate), an anti-cancer drug, on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office. Petitioners are now demanding that the Combivir patent application be rejected on similar grounds.

Here is a part of another press release that shows how people are being blinded by denying them access to affordable medicines:

Many patients with advanced HIV/AIDS can fall prey to the infection, cytomegalovirus (CMV) which will if untreated, lead to total and irreversible blindness in a very short space of time – sometimes just weeks.Blindness caused by CMV is preventable, but the most available treatments are invasive and far from ideal – injections directly into the affected eye or intravenous, twice-daily treatment requiring a long stay in hospital.There is a better medicine available – an oral medication, valganciclovir, produced by Roche. This drug is patented in China and the company charges US$ 10,000 for a four-month supply – simply too expensive for the vast majority of people most at risk of going blind. It's a similar situation in both India and Thailand – both middle- income countries where the product is patented. While the manufacturer offers discounts to the poorest countries – mainly in sub-Saharan Africa – middle-income countries including China are offered no such discount and are charged the same as wealthy countries.Dr. Peter Saranchuk has worked in China in both of MSF's HIV projects – in Nanning and the recently closed XiangFan project treating patients with HIV/AIDS. He describes his experiences in treating CMV and the frustration of seeing patients suffer because the best medicines are unaffordable.

My previous post Patients versus Patients! focussed on one Swiss company Novartis. Here is another Swiss company, F Hoffman-La Roche that seems to have been involved in a shady deal to obtain a patent in India. A case is going to be filed in the Madras(Chennai) High Court against the violation of fundamental rights as well as the weakened patent law.

Here is the link to another battle that is taking place in the Indian courtrooms, this time between the Brazilian AIDS advocacy group ABIA (Brazilian Interdisciplinary AIDS Association) and the Indian NGO SAHARA (Centre for Residential Care & Rehabilitation) on one side and the American firm Gilead Sciences on the other.

Also, take a look at this link to an interesting discussion from the XVI International AIDS Conference.

It is clear from all these links that the Indian courts have become the battleground in a war which will determine the fate of millions of humans around the world. The evil forces will use the dirtiest tricks to succeed in their nefarious designs of killing people by denying them access to life-saving medicines and deriving pleasure in watching them suffer and die. They are true sadists! Shame on them!

(To be continued)

Related post:

Patents versus Patients! (Part 1)

1. Do you trust professional networking sites to collaborate/connect with peers?
2. Do you use the web to search or collaborate with peers?

They found that 86% do in fact trust these sites and 89% use the web for search or to collaborate with peers. About 66% of respondents were from Europe and Asia. Curious how the responses would change with a U.S. only physician audience. The findings underscore a change in physician behavior that we should follow.

Dr. Elisabeth George, Technical Adviser, NICE
Trevor Leighton, VP Pricing & Reimbursement, Shire
Anne-Toni Rodgers Director, Government Affairs and Public Policy - Europe, Baxter
Dr. Rainer Walenta, Director Global Pricing & Reimbursement, Solvay Pharmaceuticals
Dr. Jacco Keja, Managing Director and Practice Leader, Quintiles Global Consulting Services
Martin Egler, Director Pharmacoeconomics, Pricing & Reimbursement Central Strategic Marketing CNS, Merz Pharmaceuticals
Tony Woodgate, Partner, Simmons & Simmons
Keith Tolley, Director, THEMA
Dr. Boyan Doganov, Director, International Projects, The International Health Care & Health Insurance Research Institute
Dr. Sabine Vogler, ÖBIG, Austrian Institute of Health
George Wyatt, Managing Director, Wyatt Health Management
Dirk Kars, Partner, Simon-Kucher & Partners
Dr Brian Lovatt, Managing Director, Cancer Deals

Now in its seventh year, Visiongain’s 7th Annual Pricing & Reimbursement conference, will provide you with the information and analysis you need to understand the dynamics of the market and create an effective pricing policy. This 2-day event will assist in better planning and marketing strategy and enable executives to share their insights on this evolving industry issue.

Key themes include:

• HE requirements in major markets and the role of HE in determining pricing / reimbursement
• Protecting innovation: Product lifecycle price strategy
• Pricing and reimbursement of oncology drugs
• Focus on the requirements of specific pricing strategies: Europe, USA, and Japan
• Producing an effective global strategy to gain market share Pricing and reimbursement continues to be one of the most talked about industry issues. I invite you to book now to avoid missing out on this premier event. I look forward to seeing you there Yours sincerely

Understand of the healthcare market dynamics and P&R environment
Gain insight into how P&R fits into company strategy and understand how
specific P&R trends are shaping the European and US markets
Hear critical information needed to arrive at the most effective strategy
Make the most profitable decisions
Participate in a range of networking opportunities

Who Should Attend:

Companies:
• Pharmaceutical and Biotechnological Companies
• Drug Regulators, Health Care Agencies and Medical Insurance Funds
• Contract Sales/ Marketing Organisations

Job Titles:
Directors, Heads and Managers of:
• Pricing and Reimbursement
• Strategic Pricing
• Price Monitoring
• Reimbursement & Market Access
• Research and Development
• Health Economics
• Economics and Government Affairs
• International Trade and Market Policy
• Parallel Trade
• Business Strategy
• Sales & Marketing
• Corporate Strategy
• Regulatory Affairs
• Outcomes Research
• Health Policy Advisors
• Analysts

Day 1

7th Annual Pricing & Reimbursement Conference

Tuesday 30th September 2008

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Reimbursement issues for oncology drugs • Evaluate what payer measures for cost-containment in oncology have already been taken or are being planned for the future • Maximize the chance of your drug gaining positive payer decisions by recognizing the influences on the reimbursement/funding decision-making process • Understand how the oncology pricing and reimbursement environment may evolve over the next five years Dirk Kars

Partner

10:50 Key competition and EU Law developments • When can dominant companies use Quota Schemes? • The AstraZeneca decision and appeal - dominance

exposure in pharma • Dual picing strategies-latest developments • The Sector Inquiry-likely outcomes and implications Tony Woodgate

Partner

11:30 Morning refreshments

11:50 UK PPRS Reform • PPRS current status of negotiations and next steps • Value based decision making - a reality? • NICE, Government and Industry, what are there roles and responsibilities?

Anne-Toni Rodgers
Director, Government Affairs and Public Policy - Europe
Baxter12:30 Using HE to support product value demonstration

• Importance of health economics for product market access
• Planning a health economic strategy for product value demonstration
• Communication strategies
• Value based pricing Keith Tolley

Director

13:10 Networking lunch

14:30 Pharmaceutical pricing & innovation; Magic, muddle or method?

Trevor Leighton

15.10 Understanding pricing and reimbursement issues of biosimilars

• Biosimiliar market access: differences between the US and the EU
• Payer perception of biosimiliars
• The impact of biosimiliars: case studies from the EU
• Finding the right strategic response

Dr. Jacco Keja

15:50 Afternoon refreshments

16:10 Strategies on rational use and cost-containment
• Introduction on key pricing and reimbursement mechanisms in the EU Member States
• Major initiatives and reforms regarding rational use of pharmaceuticals and/or cost-containment
• Discussing their effects and impact
• Outlook

Dr. Sabine VoglerÖBIG, Austrian Institute of Health

16:50 Strategies for achieving the most effective patent protection
• Regulatory issues to consider when seeking patent protection
• Claim drafting strategies
• Protecting from design arounds by using method and process claims
• Use of trade secret protection
17:40 Closing remarks from the chair

17:45 Networking Drinks Reception

Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2

7th Annual Pricing & Reimbursement Conference

Wednesday1st October 2008

09:30 Registration and refreshments
10:00 Opening address
10:10 How to develop an effective pricing and reimbursement strategy

• Market access - critical success factors
• What payers are looking for
• Commonly used techniques / procedures
• Payers are setting the rules

Martin Egler

10:50 Pricing and reimbursement series: NICE its impact on the UK healthcare system and beyond
• Overview of the UK pricing and reimbursement system and the role NICE plays in it
• Analysis of the key issues facing NICE and the measures being taken to rectify them
• Discussion of case studies to illustrate the effect of and response to key NICE rulings

Dr. Elisabeth George

11:30 Morning refreshments
11:50 The impact of different European pricing and reimbursement systems on the pharma industry

Dr. Rainer Walenta

Director Global Pricing & Reimbursement Solvay
12:30 Pricing and reimbursement in North America

• The proven techniques that can predict the long term
• Understanding the risks involved
• Resulting predictions for the US pricing environment in the USA

13:10 Networking lunch
14:30 Canadian pharmaceutical reimbursement – From CDR to success

• Overview of pharmaceutical reimbursement in Canada
- Public and private markets
- How Canada’s public reimbursement compares within the OECD
• The Common Drug Review (CDR) – Gateway to public reimbursement
- What is the Common Drug Review (CDR), what does it do and where is it going?
- The impact of a CDR recommendation on public reimbursement
• Canada’s national pharmaceuticals strategy
- Behind the rhetoric – what you need to know
• Reimbursement strategies
- How you can succeed in the Canadian market
George WyattManaging DirectorWyatt Health Management15:10 Current pricing and reimbursement in Bulgaria and neighbouring countries
• Current P&R systems implemented
• Role of EU guidance
• Pros and cons
• Future trends analysis for Balkan pharmaceutical market

Dr. Boyan Doganov

17:30 Chair’s closing remarks
17:40 End of conference

For more information kindly visit: http://www.bharatbook.com/seminars/7th-Annual-Pricing-&-Reimbursement.asp

Between 1983 and 2003, India’s science PhDs went up from 3,886 to 6,318, while it went up from 2,430 to 3,780 in the UK. South Korea, which began with 281 PhDs, surged to 3225, while Taiwan began with 8 and closed at 202.

Source: Times of India

--We may not hear a whole lot about health care reform this year.  Between gas prices and trying to figure out which candidate is lying the most, it might just get lost behind the rhetoric of what is going to end up a really dirty election year.  But make no mistake about it, health care reform is on the agenda, and it would be far better to start off with regulating pharmaceutical ads (you can't advertise cigarettes, but you can advertise Xanax) than to just immediately throw ourselves into a massive national health care program.--

I was greeted this morning by the news of a possible miracle drug for treating social phobia, anxiety and autism--oxytocin.  On the surface, this would seem a wonderful thing.  Many, perhaps as many as 1 in 10 people, suffer from severe shyness, and the numbers of people diagnosed from autism seem to be increasing every year.  While there is some debate as to the validity of all these stats, you won't find any debate on it from me.  People with autism in their family know it when they see it, and if you think you suffer from severe social anxiety then you are probably right.  But even just for those who really need it (which apparently will be at least 10% of the population), the costs are going to be prohibitive. 

But here comes the real problem--it won't be prescribed just to those who really need it.

Call me anti-conservative on this issue if you like, but allowing pharmaceutical companies to advertise directly to the general public is insane.  Essentially, we're encouraging mild hypochondria, self-diagnoses, and self-treatment--because the general public decides it has a problem then goes rushing to the doctor and demands the new drug.  If that's not bad enough, they actually end up getting the drug more times than not, and when they don't it's usually because the drug companies have marketed so extensively to the doctors that they decide to write a prescription for an alternative drug.

Just to physicians, pharmaceutical companies have spent billions and billions of dollars in marketing antidepressants.  Now think of all the ads you see on television and in magazines for them.  It is what has helped to create the so-called Prozac nation.  It is one of the leading reasons you are paying $800 each month (not including what your employer is paying) for health insurance on your family (unless you're a heavy driver, you probably are paying much less each month on gas).

Every time someone blows their nose, there's a new prescription written for nasal sprays and antihistamines even though products like Zyrtec can now be bought OTC in generic form.  Every time someone is stressed out by work, another prescription is written for anti-anxiety medication.  People are happy as clams to pay $30 to $50 for the latest in pharmaceutical living, not considering that their insurance is paying another $300 behind the scenes and that their cost for insurance is going to go up again next year.

In fact, it is estimated that 30% or more of all health treatments are completely unnecessary.  Some of that is dishonest work pushed on patients by doctors and hospitals, but a lot of it is by patient request, too.  And this year, health expenditures will equal a full 16% of our GDP, so imagine what a difference little changes could make.  Little changes like stopping the drug pushers from pushing.

Don't get me wrong.  I'm not against pharmaceutical companies.  Anyone who suffers from disease and finds relief in medicine understands how important a healthy pharmaceutical industry is (I could kiss every employee of the pharmaceutical company that saved my wife and son's lives when she was pregnant with him).  We must continue to encourage the companies to have profits and to spend money on researching new drugs.  But they simply cannot be allowed to push those drugs (and the conditions that accompany them) on the general public.  It's just not healthy and not working out for our health care system.  One can only imagine how oxytocin, already called the "love drug" by the media, will be advertised.

We may not hear a whole lot about health care reform this year.  Between gas prices and trying to figure out which candidate is lying the most, it might just get lost behind the rhetoric of what is going to end up a really dirty election year.  But make no mistake about it, health care reform is on the agenda, and it would be far better to start off with regulating pharmaceutical ads (you can't advertise cigarettes, but you can advertise Xanax) than to just immediately throw ourselves into a massive national health care program.

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Those were the days. A March 2008 report by IMS Health predicts no relief from the slow growth. For one thing, Lipid regulators (such as Pfizer’s blockbuster cholesterol fighter, Lipitor), is the largest therapy class in the U.S., but sales are declining. Even more grim, the report says that last year new product launches in the pharma industry were at their lowest level in three decades. - Jessica Shambora

Next: Where the pharma industry is healthy

In the interview Walker emphasized that several other heavily regulated industries have already successfully made the transition to an ISO 9000-based QMS and that all approaches to implementation are not equally efficient and effective. Properly implemented, the transition is enormously beneficial to the enterprise and fully consistent with best business practices. Conversely, if approached solely as an onerous compliance imperative, the whole exercise can be an expensive, non-value-added chore. Caveat Emptor!

Business Enterprise Mapping’s approach is unanimously considered best-in-class by those accredited third-party auditors that have encountered it.

See the full article at:

http://www.pharmamanufacturing.com/articles/2008/058.html

Australian Broadcasting Corporation Article: 'Hillbilly heroin' makes its mark on Australian streets

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Readers of this blog already know my opinion on this ridiculous “Hillbilly Heroin” moniker—so I’ll ignore that for now. The real story here is that the illegal use and sale of painkillers like OxyContin in Australia has exploded from practically non-existent, to representing nearly half of the users at some safe injection sites*—just within the past 2 years.

I really don’t need to elaborate further as the original ABC article is excellent—except to point out that this painkiller epidemic, though already rampant in the U.S., is becoming a truly global problem. As the worldwide “War on Drugs” remains steeped in constant failure, we must find new solutions to combat what is truly a new form of deadly addiction.

• View other Painkiller Epidemic Updates

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*Safe injection sites or "supervised injecting centers" are clinical facilities where illicit drug use is permitted; often clean needles and other injection equipment is supplied.

Image courtesy Wikipedia

Takeda's Actos may help prevent diabetes - Actos, a pill to treat diabetes, can prevent development of the disease in people with early symptoms, U.S. researchers reported...more

Amylin's once-weekly Byetta looks promising for lowering blood sugar - Amylin Pharmaceuticals Inc said on Monday that a once-weekly version of its Byetta type 2 diabetes medicine led to additional improvements in blood sugar levels over the currently available drug that must be injected twice a day...more However, their stock was pounded after many positive news reports of competitive drugs.

Ranbaxy up for grabs - Daiichi makes bid. Also, strikes deal with Pfizer over generic Lipitor.

Elan/Wyeth experimental Alzheimer's drug continues to progress in clinical trials - A closely watched Phase II study of an experimental Alzheimier’s drug being developed by Elan and Wyeth shows the med appears to be effective in some patients. Known as bapineuzumab, the drug failed to achieve statistically significant results in the primary outcomes, but managed to do so in subgroups lacking a higher genetic risk to develop the disease...more

J&J, Red Cross, call it quits on legal fight - The lawsuits had an absurdist, has-it-really-come-to-this quality about them. Johnson & Johnson and the Red Cross — Band-Aids and baby powder, blood drives and disaster relief — were suing each other over the rights to the red cross emblem that both had long shared. Now, after getting most of its suit against the Red Cross tossed out by a judge, Johnson & Johnson has picked up its legal toys and gone home. The company said today that it is dismissing its remaining claims against the august nonprofit. And the Red Cross, for its part, threw out its counterclaims against J&J. The companies’ statement is online here more

FDA and Genentech in a staredown - Last year, Genentech caused a ruckus by restricting distribution of its Avastin med to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis was approved to treat the malady, but at $2,000 a dose will cost about 40 times as much...more

Cancer drug Gleevec may help with strokes? Very cool - A highly effective leukemia pill may reduce complications and boost the effectiveness of a treatment for the most common type of stroke, an international team of researchers said on Sunday. Studies in mice showed giving Gleevec or imatinib, a drug made by Novartis AG, significantly reduced bleeding in the brain associated with the clot-busting drug known as tissue plasminogen activator or tPA...more

Millennium/Takeda's Velcade gets expanded approval - Takeda Pharmaceutical Co, Japan's largest drugmaker, won U.S. approval to promote its cancer drug Velcade for earlier treatment of multiple myeloma, the company said on Friday...more

¹Gareth Macdonald, In-pharma Technologist.com

read more | digg story

A study conducted by Dr. Ana Rose Childress and Dr. Charles O’Brien of the University of Pennsylvania shows drug craving “triggers” are activated in the part of the brain responsible for emotions and rewards.

Cocaine addicts were shown a series of images for 33 milliseconds each—not nearly enough time to register consciously—yet brain imaging of the study participants showed activity in the limbic system (the area of the brain that is directly associated with reward) that coincided with the images.

“[The study] is the first evidence that cues outside one’s awareness can trigger rapid activation of the circuits driving drug-seeking behavior.”

-Dr. Ana Rose Childress

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Original post:  Study Shows How the Subconscious is Related to Drug Addiction

Image courtesy Wikipedia

CNN, in a recent “mainstream” CNN.com/health article, included prescription drug addiction in their list of Five symptoms men shouldn't ignore. This mention not only represents a very real danger, but may mark the first time a major news outlet has addressed the subject of prescription drug addiction alongside relatively commonplace health concerns like a large belly and frequent urination.

In my opinion, this is further evidence that the "story" I’ve been calling the Painkiller Epidemic is very big, very real, and very likely to rear its ugly head on the national stage very soon. Once a concern only on the radar screens of addiction counselors, the subject of painkiller addiction finally seems as though it may be slowly working its way, via the mainstream media, into the public consciousness.

• View other Painkiller Epidemic Updates

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CNN.com/health article: Five symptoms men shouldn't ignore

Image courtesy Wikipedia / CNN

"This is out of control… There's a whole new type of junkie out there that wants these [prescription] drugs, and they're carrying guns."

—Pharmacist Denise Stiles-Yount

In this space just a few days ago, I wrote a post about a study which showed that, in Florida in 2007, prescription painkiller use resulted in 300% more deaths than the usual “street drugs”. Now we are finding that, in Florida at least, painkillers are not only gaining in popularity, but are in greater demand than so-called “hard drugs” like cocaine and heroin. Florida may well prove to be ground zero for the unfolding of the painkiller epidemic story.

• View other Painkiller Epidemic Updates

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Source: Jacksonville.com - Top drugs on street now Rx

The Department of Veterans Affairs (VA) has been recruiting veterans for pharmaceutical drug testing, using miniscule cash payments as an enticement. One of these experiments involved Pfizer's anti-smoking drug Chantix.

In the Chantix study, the VA took 3 months to alert patients of severe side effects—and then only after one of its participants, James Elliott, had a psychotic episode involving a confrontation with police. The Food and Drug Administration (FDA) warns of possible side effects from Chantix, including hallucinations, suicide attempts and psychotic behavior, but these warnings were not passed on to patients prior to the study.

Among other accusations, at least one medical ethicist claims that the VA violated basic protections for humans in medical experiments during its anti-smoking drug trials.

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For more on this story:

• The Washington Times: VA Testing Drugs on War Veterans
• The Washington Times: Disposable Heroes
• Chantix (varenicline) Official Site: http://www.chantix.com
• Pfizer, Inc.: www.pfizer.com

Image Courtesy Wikipedia

I remember a similar discussion a couple months back about birth control hormones ending up in the drinking water supply. I sort of shy away from this topic because (a) it's really gross to think about drinking water that was formerly pee! and (b) I'm really conflicted. I've always been a pretty strong live and let live person. I certainly would never want women who wanted it to not have access to birth control. At the same time, I think these cases are good reminders that "live and let live" has some serious challenges, in that we all live in the same place.

The same issue comes up for me with chemical laundry detergents and dish cleaners. In general, I don't use them myself (to be honest, more because they give me a rash), but I've never really pushed them on people in my life. Still, nothing really goes away when it goes down the drain... and sometimes it's just coming right back out the faucet.

I'm conflicted because I guess I am feeling a little burned out on the idea of a consumer revolution. Are we really going to demand safer products? Do we have time to? Many alternative are available now and most people don't buy them (can't afford to? can't find them? don't care?). But the idea of regulation is a scary ethical minefield. Some things, such as sunscreen that still protects from sunburns but doesn't hurt the ocean as much seems pretty uncontroversial. But birth control? What about life-saving drugs that get into the water supply?

I wish we could trust the government to decide what is reasonable for public health and safety versus individual rights, but it's pretty obvious that we can't (and if we do while the person we like is in power, it's all subject to change when their term is over).

I might sound a bit pessimistic, but I'm not. I'm just mulling it over. I definitely know a lot folks who think changing consumer behavior is where it's at. I just don't think we can do it until we change consumers back into citizens, and that's a formidable task. (I'll do it if someone else pays my rent.)

In the meanwhile, there is a silver lining - at least our internal organs and our sushi won't get sunburned!

a pretty informative and overly balanced link on tap water (though admittedly not without bais)