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Despite duty cut, prices of some life-saving drugs remain same | ||||||
|
Prices of drugs administered for respiratory diseases remained unchanged in the local market despite a significant cut on the import duty of the items.
Earlier, the finance adviser in his budget address said reduction of import duty will make such medicines available in the local market at cheaper price. There are millions of asthma and similar patients in the country.
Shahidul Islam, a resident of Mirpur, who has been suffering from respiratory problems for the last 10 years, told the FE that he became happy after the budget speech, but was disappointed when the prices of inhalers did not decrease.
While visiting drug stores at Shabagh, Mitford and Dhaka Medical College area, it was found that most of the imported inhalers were being sold at previous prices.
Two local pharmaceutical companies manufacture drugs for asthma and similar patients while about half a dozen popular brands are imported from abroad.
Square Pharmaceuticals produces Sulprex which is sold in the market for Tk 225 while Beximco Pharma's Asthmasol for Tk 110 - both companies retaining their previous prices.
Among the popular imported drugs Ventolin is selling at Tk 180 and Seritide at Tk 1116.70 up by Tk 86 from its previous price.
Shamsur Rahman, a product executive of Glaxosmithkline, told the FE that they raised the prices of Seritide due to the price hike of the same in the international market.
"Our import has become costlier. For this reason, we increased the prices of the item since July 1," he added.
Another official working at a local pharmaceutical company said the reduction in import duty will not have any impact on the selling price unless the government re-fixed it.
While talking to the FE, Nazmul Hasan, general secretary of Bangladesh Association of Pharmaceutical Industries (BAPI) said the drug manufacturers do not set the selling prices - it is fixed by the drug administration.
To facilitate the quick movement of drugs, importation law for FDA approved drugs should be eased such that they can be freely imported out of any Indian port. This will remove the limitation of being able to import only through the four ports where Assistant Drug Controllers are present.
Continuing on the same lines, duty on life-saving drugs needs to be eliminated completely. Specific allowances akin to investment allowance under Section 32A are needed to provide a fillip to the healthcare service sector. Scope of medical research and development initiatives to get immediate priority; development of right mechanism to pave way for better human resource infrastructure
But what we see and experience?
India-WHO Programme in Essential Drugs have published four Lists of
Essential Drugs in the years 1994, 1996, 1998 and 2002. This list
delineates drugs which could be prescribed for both Outpatients and
Inpatients.
emergency. Medicines which have the potential to sustain life and/or
prevent further complications.? This list will potentially receive
special considerations like exemption of import duties etc, it is always expected but the Reality is quite DIFFERENT as MNCS have launched an all out Monopolistic Aggression against the suffering people and CASH In the helplessness of the masses!
Drugs which require immediate administration within minutes post or
during a medical emergency.
Medicines which have the potential to sustain life and/ or prevent
further complications.
Adenosine Injection
Adrenaline Bitartrate Injection
Aminophylline Injection
Amiodarone Injection
Antisnake venon inj polyvalent Injection
Antitetnus Human Immunoglobulin Injection
Atropine sulphate 0.6mg/ml Injection
Calcium chloride Injection
Chloroquine phosphate 64.5 mg/ml (5ml amp) Injection
Dextran-70 Injection
Diazepam 5mg/ml Injection
Dicyclomine hydrochloride 10mg/ml Injection
Diphenhydramine Injection
Diltizem Injection
Diptheria Antitoxin Injection
Dobutamine 50mg/ml (5 ml amp) Injection
Dopamine hydrochloride 40mg/ml (5ml amp) Injection
Epinephrine hydrochloride 1mg/ml Injection
Flumazenil Injection
Fresh Frozen Plasma Injection
Frusemide 10mg/ml Injection
Glucose with sodium chloride Injection
Glyceryl trinitrate 5mg/ml Injection
D50% Injection
Haloperidol Injection
Heparin sodium 5000IU/ml Injection
Hydrocortisone sodium succinate 100mg/ml Injection
Insulin soluble (bovine + porcine or porcine) 40IU/ml Injection
Lignocaine IV 2% Injection
Lidocaine 2% Injection
Magnesium sulphate Injection
Mannitol 10%, 20% Injection
Metoclopramide 5mg/ml
Metoprolol 1mg/ml Injection
Morphine sulphate Injection
N/2 saline Injection
N/5 saline Injection
Naloxone 0.4mg/ml Injection
Neostigmine 0.5, 2.5mg/ml Injection
Oxygen Inhalation
Oxytocin Injection
Pancuronium 2mg/ml Injection
Phenobarbitone 200mg/ml Injection
Phenytoin 50mg/ml Injection
Potassium Chloride Injection
Pralidoxime chloride (2-PAM) 25mg/ml Injection
Protamine sulphate Injection
Rabies vaccine Injection
Ringer lactate Injection
Salbutamol sulphate Inhalation
Sodium bicarbonate Injection
Succinyl choline 50mg/ml Injection
Streptokinase Injection
Tetanus Toxoid Injection
Vitamin K 10mg/ml Injection
After acquiring Ranbaxy Laboratories, Japan’s Daiichi Sankyo has jumped to the second position in the domestic pharma market, behind market leader Cipla. Ranbaxy is India’s largest pharma company by sales, but is ranked second in the Rs 35,000-crore domestic market.
Similarly, the world’s largest drugmaker Pfizer will be among the top eight firms in the domestic market once its integration with Wyeth’s India arm gets over. Pfizer agreed to buy Wyeth for $68 billion in January this year. Currently, the American firm is ranked 12th in the domestic market.
Last week, Pfizer announced the acquisition of ICICI Venture-owned RFCL’s Rs 100-120 crore animal healthcare business. Besides, it’s in talks with Indian pharma companies for a strategic acquisition that could further strengthen the American giant’s hold in the domestic market.
Another US major MSD will be catapulted to the top 35 in India, after it completes its acquisition of rival Schering Plough. Similarly, French major Sanofi Aventis, which is looking for acquisitions in India, could see a successful bid putting it back to the top 10 from its current position of 16.
Before the recent round of M&As, India’s pharma market had only one foreign player — the UK-based GlaxoSmithKline (GSK) — among the top 10. Multinational companies, such as Pfizer, GSK and Novartis, played a dominant role in the domestic market till as recent as early-2007, but lost out to homegrown generics majors, such as Cipla, Ranbaxy and Zydus Cadilla.
HDFC Securities institutional research VP Ranjit Kapadia said: “Till mid-90’s, foreign pharma firms dominated the Indian pharma industry. The introduction of the drug price control order in 1995 brought many of their drugs under price control, thus restricting their growth. At the same time, Indian pharma companies launched a slew of generic drugs outside price control, which boosted their growth.”
Besides consolidation, a new patent regime will also drive the growth of foreign companies in India. Launched in 2005, the new patent laws provide patent holders exclusive marketing rights in India for 20 years. This will protect foreign pharma firms that hold patents from losing out to Indian companies that make low-cost copies of off-patent drugs.
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SOHM India Expands Distribution Network for Generic Pharmaceuticals in Four Northern States in India
BUENA PARK, CA -- 06/11/09 -- SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today that the Company has expanded its distribution network for generic pharmaceuticals in four Northern states of India. The domestic pharmaceutical market in India is significant at around $10 billion in annual sales. Annual growth rates have doubled for the domestic market from 7% to 14% over the past couple years. The Company expects pharmaceutical sales in India to be a significant contributor to revenue and earnings in 2009.
India's population is in excess of 1 billion, and its growing middle class has pushed growth in the generic pharmaceutical market for both life-saving and life-style drugs. India is one of the only emerging markets that has many of the leading pharmaceutical multinationals listed and publicly traded on domestic stock exchanges, including Pfizer, Novartis, and GlaxoSmithKline.
"By 2010, between $50 and $80 billion of brand-name drugs around the globe will no longer have patent protection," stated Vice President for Corporate Strategy at SOHM, Inc. "This is a huge advantage for Indian based generic pharmaceutical manufacturing companies like SOHM as we can immediately start producing and selling generic drugs at a significant discount while still maintaining significant profit margins. Our contract manufacturing in India also allows us to cost-effectively manufacture compounds in very small quantities and complete sales orders that large drug manufacturers cannot profitably complete. We have effectively positioned the Company in this niche allowing us to create revenue and earnings in a large and underserved area of the India pharmaceutical market."
About SOHM, Inc.
SOHM, Inc. is a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories. Global headquarters is located in North America with manufacturing sites in India. Generic pharmaceuticals are exported globally with a focus on distribution in emerging markets in Africa, Latin America, and Southeast Asia. www.sohm.com
Safe Harbor Statement
This press release contains statements, which may constitute "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of SOHM, Inc., and members of their management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Important factors currently known to management that could cause actual results to differ materially from those in forward-statements include fluctuation of operating results, the ability to compete successfully and the ability to complete before-mentioned transactions. The company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.
For more information, please contact:
SOHM, Inc.
Investor Relations
(714) 522-6700
Email Contact
http://www.earthtimes.org/articles/show/sohm-india-expands-distribution-network,857651.shtml
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"India is a welfare state. You should see to the welfare of all the people and not that of the rich. Life-saving drugs should be included. We will monitor the case till it is done," a Bench of Chief Justice V N Khare and Justice S B Sinha said.
On July 11 the government had informed the court about inclusion of 75 new drugs to the essential medicines list.
When it was pointed out that several important drugs for treatment of typhoid, Hepatitis A and cardiac diseases have not been included in the essential medicines list, the Bench ridiculed the Central government for taking different stands at different points of time.
Objecting to linking the issue of inclusion of a medicine to the turnover of a company manufacturing the same, the Bench asked: "what is this - if the price goes up and the turnover increases, the medicine will go out of the list?"
Brushing aside explanations offered by additional solicitor general Raju Ramachandran, the Bench said: "We were given to understand by Attorney General Soli J Sorabjee that apart from the existing medicines, many more would be added to the essential drugs list".
It further said, "if proper steps are not taken by the government, we will pass a judicial order."
The court granted four weeks' time to the Centre file a proper affidavit regarding its final stand on the price control policy.
The court was hearing the Centre's appeal challenging a Karnataka High Court order that virtually stayed the DPCO and directed the government to include life-saving drugs in the list of essential medicines.
The high court had passed the order on a public interest litigation filed by one K S Gopinath alleging that if the DPCO was implemented the prices of the drugs would be hiked on the whims and fancies of the manufacturers.
Ramachandran contended that the apex court had stayed the High Court order but had asked the government to review the list, which had been done and 75 new drugs had been added. As the needful had been done, he said, the government should be permitted to implement the DPCO.
Gopinath's counsel C A Sundaram said that the drug manufacturers were interested in immediate implementation as it would give them leverage to take the drugs out of DPCO on the basis of their turnover.
Darshak Sanghavi, a Pediatric Cardiologist, makes a well reasoned case against the use of QALY logic saying that it creates a very powerful bias against any form of expensive life saving treatment, and in favor of preventive measures. With multi-lateral institutions and aid agencies increasingly relying on QALYs, poor people suffering from fatal diseases like AIDS or requiring expensive life-saving medical interventions are most likely to be denied any external assistance and left to die.
Citing the example of India and Brazil which started manufacturing generic versions of expensive drugs, he argues that health care costs, especially for life saving drugs, are entirely elastic and negotiable. It was also found that collective bargaining reduced costs considerably, so much so that Brazil is today able to treat all its AIDS patients with antiviral drugs, virtually free of cost.
Staff Reporter
Thomas says there are complaints about exorbitant prices |
Says government will scrutinise misleading medical advertisements
Claims National Food Security Act will benefit the poor
KOCHI: Union Minister of State for Agriculture, Food, and Civil Supplies K.V. Thomas has said that the Central government will consider regulating the prices of life-saving medicines.
Inaugurating a State meet and workshop for retail pharmacy owners, organised by the All Kerala Chemists and Druggists Association (AKCDA) here on Saturday, Prof. Thomas said there were widespread complaints about exorbitant prices of life-saving medicines and irregularities in their prescription.
Corrective measures
The government, he said, will examine these complaints and take necessary corrective measures.
Prof. Thomas said the government would closely scrutinise misleading advertisements of medical companies in the print and visual media and take stringent punitive measures.
The Minister said the Central government’s decision to enact a National Food Security Act was meant to take the fruits of development to the poor in the country.
The Act will benefit more than 12 crore people belonging to the BPL (below the poverty line) category. If the country has to move forward the benefits should reach people in the lowest strata.
Inaugurating a technical session organised in connection with the meet, Public Works Minister Mons Joseph said that medical companies should be able to uphold the trust of the Central and State governments.
Since the public is unable to judge the fairness or otherwise of medicines, the responsibility rests with governments and the medical companies.
M.P. Abdul Gafoor, president of the association, presided.
And see this Financial Express story to assess the HYPOCRICY Inhuman!
Life-saving drugs could now become affordable neglected
Ranjit Shahani
Posted: 2008-03-01 22:07:47+05:30 IST
Updated: Feb 29, 2008 at 2227 hrs IST
The proposed reduction in customs duty on life-saving drugs and bulk drugs used to make them from 10% to 5% and the total exemption from excise and countervailing duties is a positive step in the right direction.
We hope that customs duty on these drugs will soon be down to zero levels. All these efforts should help bring down drug prices.
The R&D weighted deduction of 125% will be available on outsourced R&D. This will indirectly boost research-oriented organisations and academia. However, in-house R&D has been neglected. Research & development (R&D) for a new chemical entity takes 15 years and is fraught with risk.
We had hoped for a 10 year holiday of 200% weighted tax deduction. This would have provided a boost to local R&D and help companies active in this space move up the value chain.
The industry is disappointed that a long standing demand to tone down penalties on transfer pricing adjustments, levy fringe benefit tax (FBT) only on expenses which escape the tax net and relate to employees of the company and exempt physician samples, have been ignored.
We hope all these will get the attention of the finance minister and he will also consider introducing a provision for granting exemption on customs duty for life-saving drugs at any time during a fiscal year.
The writer is vice chairman & MD, Novartis India Ltd
The shortage has put patients in a difficult situation as medicines for heart ailments, blood pressure and diabetes are out of stock. The patients are getting medicines from neighbouring states.
The Jharkhand Chemist and druggist Association (JCDA) has given a strike call from April 17 if the state government fails to rectify the anomalies in the VAT. They are opposing imposition of VAT at multiple points.
--Edited IANS
'"/>
Pharma industry welcomes excise duty cut on drugs
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New Delhi: The domestic pharmaceutical industry today welcomed Finance Minister P Chidambaram's proposal to cut excise duty on drugs and said the move will help in making medicines more affordable to the common man.
Hailing the Budget as extremely positive, Ranbaxy Chairman and Managing Director Malvinder Mohan Singh said apart from excise cuts, the Finance Minister's decision to include outsourced research and development operations under the exemption limits would boost drug discovery operations in the country.
"Outsourced R&D has been given a 125 per cent weighted tax deduction and it is certainly expected to boost the sector in a major way. Overall, it is extremely positive for us keeping in mind that this is the last full fiscal budget of this Government," Singh said.
He said the move would boost investments in R&D and would encourage a lot of contract researchers to set shops in India.
The Finance Minister proposed to totally exempt certain specified life saving drugs and bulk drugs used in the manufacturing of such drugs from excise duty while reducing customs duty on such products to five per cent from the present 10 per cent.
Addressing pharmaceutical industry's long pending demand, Chidambaram has also proposed to reduce excise duty on all goods produced in pharmaceutical sectors to eight per cent from 16 per cent.
Drug price regulator National Pharmaceutical Pricing Authority (NPPA) Chairman Ashok Kumar said the Finance Minister's move to cut excise duty would ensure better availability of drugs to patients.
"From NPPA's point of view, Finance Minister's proposals would certainly increase the availability of drugs and would reduce prices which would benefit customers. We do hope that industry would pass on the benefits to the customers," Kumar said.
Bulk drug manufacturer Arch Pharmalabs' Managing Director Ajit A Kamath said the excise duty cut would ensure development of pharmaceutical industry across the country.
"Due to excise benefits, a lot of manufacturers were migrating to tax heavens in Uttarakhand and Himachal Pradesh. The excise duty cut would ensure balanced growth of the industry across the country," Kamath said.
He, however, said that Finance Minister could have incentivised R&D activities further.
Echoing this view, Nicholas Piramal said that budget is disappointing for R&D.
"It is a pro bio-pharma budget and would help small scale units but it is disappointing from R&D point of view," a Nicholas Piramal spokesperson said.
Alok Saxena, Director of Elder Pharmaceuticals, said the budget could have a negative impact on contract manufacturing companies operating in excise free zones.
"A well-balanced budget with good sops for pharmaceutical industry. It could, however, have a negative impact on contract manufacturing companies operating in excise free areas," Saxena said.
Contaminants In Life-Saving Drug Detected Using Simple New Method
Also Included In: Medical Devices / Diagnostics
Article Date: 18 Nov 2008 - 8:00 PST
Now, University of Michigan researchers have demonstrated a simple, inexpensive method for detecting contaminants in heparin, a development that could prevent such tragedies in the future.
The new method is described in a paper published online Nov. 14 in the journal Analytical Chemistry.
The method relies on potentiometric polyanion sensors originally developed in the lab of U-M researcher Mark Meyerhoff as a tool for detecting heparin in blood. In the latest work, Meyerhoff and coworkers show that the disposable sensors also can be used to distinguish pure heparin from heparin that is tainted with small quantities of oversulfated chondroitin sulfate (OSCS), the culprit in the recent deaths.
"In this technique, the magnitude of the voltage you get from the sensing membrane is dependent on polyion charge density," Meyerhoff said, "and because the contaminant has a higher charge density than heparin, the method allows us to detect the contaminant in the presence of excess heparin."
The new method is simpler and less expensive than analytical methods such as nuclear magnetic resonance (NMR) and capillary electrophoresis (CE), which have been suggested for detection of OSCS conta
Meyerhoff, who is the Philip J. Elving Professor of Chemistry, envisions the procedure being used on site in drug manufacturing plants to screen raw materials or finalized, biomedical grade heparin products for contaminants.
No life-saving drug exempted from duty |
Sunday, June 14, 2009 By Muhammad Qasim ISLAMABAD: The government has allocated Rs 23.15 billion for the health sector under the Public Sector Development Programme (PDSP) for the fiscal year 2009-10, which is 66 per cent higher than that of the allocations made for the health sector under the PSDP for the year 2008-09. In Fiscal Year 2008-09, Rs 13.99 billion were allocated for the health sector under the PSDP while the current budget allocation under health affairs and services was Rs 5.49 billion. For the year 2009-10, the government has allocated Rs 6.5 billion for health affairs and services. It is, however, important that of the total Rs 23.15 billion allocations under the PSDP, above Rs 21 billion would be spent on the ongoing programmes and old initiatives during 2009-10 while only Rs 2 billion has been allocated for new schemes. Like the year 2008-09, a major chunk of the allocations under the PSDP would be spent on national programmes for Family Planning and Primary Healthcare and Expanded Programme of Immunisation in 2009-10. “National programmes for Family Planning and Primary Healthcare and Expanded Programme of Immunisation (EPI) continue to receive top priority with respective allocations each of Rs 7 billion and Rs 6 billion,” said Minister of State for Finance and Economic Affairs Hina Rabbani Khar while presenting the budget for year 2009-10. In 2008-09, the government has allocated Rs 6 billion for strengthening the EPI while Rs 5.5 billion was allocated for the National programmes for the Family Planning and Primary Healthcare. The minister said the health strategy had been devised on the key principles of equity, universal access to essential healthcare, timelines, results, accountability, strong leadership and strategic coordination of the overall effort. “The strategy envisages addressing special needs of the vulnerable population, especially women and children particularly in the rural areas,” she said. For the fiscal year 2009-10, the government has proposed a concessionary import duty rate on 35 raw materials used in pharmaceuticals, medicines and diagnostic kits while zero rate sales tax on import and supply of wheelchairs for the special people has been proposed. However, no life-saving drug has been exempted completely from duty. In 2008-09, as many as 18 life-saving drugs used for treatment of cancers were exempted from duty while medical equipment, apparatus, reagent and disposables were exempted from sales tax. The minister announced that the Prime Minster’s Emergency Action Plan for disease had been launched that would cost Rs 11 billion in the next five years. The government has also announced increase in tobacco taxation as per the World Health Organization’s recommendations for protecting the health of the population. For provision of clean drinking water to all, the government has initiated the Clean Drinking Water Project in 2008-09 and proposed allocation of Rs 2.2 billion under which filtration plants were to be installed countrywide with specific focus in village areas. “Clean drinking water is the first line of defence in protecting public health. Under the Clean Drinking Water Project, the work for installation of filtration plants is going on and about 600 plants have been operationalised till now,” said the minister, adding it was proposed that 3,500 plants would be installed one in each union council by the end of Fiscal Year 2009-10 for which an amount of Rs 6 billion was being allocated. Also in the short to medium term, the government would utilise the Benazir Income Support Programme (BISP) as a platform for complementary social assistance programmes, the main being health insurance for the poor and vulnerable in 2009-10. “This will cover full hospitalisation, pregnancy, day-care treatment, diagnostic tests and accident compensation for earning members of the family to a maximum limit of Rs 25,000 per family per year,” said the minister. The government has also allocated an amount of Rs10.8 billion for different worker welfare development schemes in the housing, health, education and technical education sectors for the Fiscal Year 2009-10. Of the total budget of Rs 6.484 billion allocated for health affairs and services for 2009-10, Rs 65 million would be spent on medical products, appliances and equipment while Rs 5.7 billion for hospital services. Rs 469 million would be spent on public health services while only Rs two million has been allocated for research and development like the previous year. Also, Rs 241 million would be spent on the health administration. |
How is sparkling wine like a life-saving drug in developing world countries? They're both targeted for destruction by EU customs officials if they're found in European ports with the wrong label on them.
A number of aid agencies are currently worried that overzealous action by EU officials in ports like Rotterdam is going to have serious health effects for people in Africa and South America. Customs officers have been seizing generic drug shipments en route from India to Brazil, Nigeria and elsewhere because of alleged patent infringement. The drugs in question are generic in both the country of origin and the country of destination, but here in the EU, some drug company or other has the legal lock on their manufacture.
Today, in an open letter in the European voice, a group of MEPs on the European Parliament's international trade committee have picked up the cause, protesting the slated destruction of three consignments of Indian-manufactured generic medicines in particular. These drugs -- clopidogrel, rivastigmine and olanzapine -- were on their way to developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Halting the shipment and planning its destruction is simply outrageous.
Note, these are not harmful or out-of-date meds. As the MEPs write:
It is vital to differentiate between illegal counterfeit medicines -- which the World Health Organization defines as medicines having a false representation of identity and/or source -- and legitimate generic medicines, which are, in most cases, simply unbranded versions of patented medicines.And the wider implications of the authorities' actions compound the trouble. Médecins Sans Frontières (MSF) actually ships generic medicines from EU-based warehouses to developing countries. Are the customs police going to break up that perfidious racket, too?
The EU has, of course, been known to destroy large quantities of American sparkling wine improperly labeled "champagne" and caught in EU ports. I am all for safeguarding consumers through protected names, but I don't see the logic of rash action and wanton waste: why smash the bottles when the producer could just be required to relabel them instead before onward shipment? Or when they could be given to charity?
But while a bit of spilt booze is a sad loss, the senseless destruction of live-saving medicines that are perfectly safe and legal in their production and distribution countries is absolutely immoral. The European Commission ought to think again here.
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This is an archived USAID document retained on this web site as a matter of public record.
U.S. Supported Lifesaving Drug Treatment for 172,000 People, During Early Months of President's Emergency Plan for AIDS Relief
FOR IMMEDIATE RELEASE
January 27, 2005
0112-05-02
Press Office: 202-712-4320
Public Information: 202-712-4810
www.usaid.gov
Contact: USAID Press Office
The American people supported antiretroviral treatment for approximately 172,000 men, women and children in the first eight months of President George W. Bush's Emergency Plan for AIDS Relief. The heartening, early progress in support for drug therapy through the bilateral program component of the Emergency Plan was announced on January 26, by the U.S. Global AIDS Coordinator, Ambassador Randall L. Tobias.
The Emergency Plan supported treatment for 155,000 individuals in fifteen of the most afflicted nations in Africa, Asia and the Caribbean, and 17,000 in countries beyond the 15 focus countries, for a total of 172,000 worldwide.
In June 2004, President Bush stated, "There's nothing better than a hopeful society in dealing with the pandemic. A hopeful society means you think you can win. A non-hopeful society says, I surrender. America is not going to surrender to the pandemic." The President's Emergency Plan, the largest international health initiative in history by a government dedicated to a single disease, is America's unprecedented five-year, $15 billion dollar commitment to bring hope to those suffering from HIV/AIDS globally.
"It is with great hope that we announce the initial treatment results of the historic President's Emergency Plan for AIDS Relief, the effort of the American people to join with our friends in the fifteen focus nations, and around the world, to fight global HIV/AIDS," Tobias remarked. "The President promised compassionate action-and under his leadership, and with the support of Congress, we have acted with unprecedented urgency and innovation."
As the lead U.S. government agency responsible for economic assistance and humanitarian relief in the developing world, USAID is proud to have a major role in this effort. "We have made the fight against HIV/AIDS a top priority, not only for humanitarian reasons, but also because the HIV/AIDS crisis threatens the prosperity, stability, and development of nations around the world," said USAID Administrator Andrew S. Natsios.
Tobias reported that the numbers reflect efforts through the end of September 2004 and that today there are many more people benefiting from U.S.-supported therapy. He stated that the President's Emergency Plan will meet its goal to support treatment for more than 200,000 people by June 2005 (one year after full implementation), well ahead of schedule. He also expressed confidence that this early success puts the Plan well on track to meet the President's goal of supporting treatment for 2 million people in five years.
Under the Emergency Plan, the United States works shoulder to shoulder with partners and friends in host nations, helping build capacity in support of each country's national strategy. Over 80% of 1271 Emergency Plan partners on the ground are indigenous organizations.
"These heartening results were achieved by the work of talented and dedicated people in-country. The President's Emergency Plan is dedicated to supporting their efforts, but the true credit rests with them," said Tobias.
The Emergency Plan is supporting national strategies to provide the full spectrum of services required for quality treatment. Quality treatment includes not only medicines, but trained clinical and laboratory personnel and counselors for treatment regimen adherence, prevention and healthy living, physical infrastructure including laboratory equipment, distribution, logistics and management systems for drugs and other commodities, treatment for opportunistic infections and other basic care, and much more.
Support for multilateral organizations is an integral part of the President's Emergency Plan. The U.S. Government is by far the largest contributor to the Global Fund to Fight AIDS, Tuberculosis, and Malaria, providing one-third of resources available currently to the Fund. Therefore, one-third of the support for treatment provided from the Fund also comes from the compassion and generosity of the American people.
Amb. Tobias made the announcement immediately before the opening of the World Economic Forum in Davos, Switzerland. He spoke at a joint press conference with leaders of the U.N. Joint Programme on AIDS, the World Health Organization, and the Global Fund, joining these partners in order to emphasize ongoing U.S. commitment to international cooperation in fighting HIV/AIDS.
The U.S. Agency for International Development has provided economic and humanitarian assistance worldwide for more than 40 years.
http://www.usaid.gov/press/releases/2005/pr050127.html.
Research assures preventive heart cureExpress Buzz - 10 hours ago Research conducted during the second phase proved that the life-saving combo of five drugs (three blood pressure- lowering drugs, a statin and an aspirin) ... EU seeks greater commitment on IPRLivemint - Jun 11, 2009 These demands mean to undermine India's ability to produce, export, and market low-cost generic versions of life-saving medicines,” said Leena Menghaney of ... Alan Berkman, 63, Activist Doctor, DiesThe Ledger - 5 hours ago At the time, antiretroviral drugs cost about $15000 a year for a patient. Now, with some American manufacturers sharply reducing their prices, ... India to prepare case on drug confiscations at European portsEconomic Times - Jun 10, 2009 New Delhi's stand is that such actions violate international patent norms that allow developing countries to source life-saving generics from other ... Movers & shakersThe Week - Jun 13, 2009 As minister of roadways, he has the task of saving the ministry from the sad state it has been pushed into by his predecessor TR Baalu's uninspiring ... SOHM India Expands Distribution Network for Generic ...Earthtimes (press release) - Jun 11, 2009 India's population is in excess of 1 billion, and its growing middle class has pushed growth in the generic pharmaceutical market for both life-saving and ... Shouldn't every Minister be a Health Minister?Hindu - Jun 2, 2009 Commerce: Provisions related to the manufacture of life-saving drugs and patent restrictions imposed on them are important areas of negotiation within the ... Indian Patent Ruling Critical to Cutting AIDS Drugs CostSan Leandro India West - Jun 4, 2009 Money freed by the lower cost of second-line anti-HIV drugs would allow governments to spend more on first line anti-HIV drugs, Amir said. ... India: Review Of Indian Patent Law In 2008Mondaq News Alerts (registration) - Jun 10, 2009 ... of "pricing" of the drug in assessing whether an interim injunction ought to be granted in patent infringement law suits involving life-saving drugs. ... Aquafresh earns its stripes at GlaxoSmithKlineTelegraph.co.uk - Jun 5, 2009 The research and development work conducted by Clarke's team perplexes some critics, who find it difficult to compare to the life-saving drugs GSK develops. ... |
'We Spend More Than Rs 36,000 Cr in R&D'
Leading company, Roche Diagnostics is increasingly moving towards providing solutions for 'personalised healthcare'. Dr Bhuwnesh Agarwal, Chairman and Managing Director, Roche Diagnostics India, discusses with Express Healthcare about how it is using new molecular insights and molecular diagnostic tests to provide tailored medicines and manage diseases better to accomplish its goal of 'personalised healthcare' solutions. Excerpts:
How has Roche Diagnostics grown since it started operations in India?
Since its inception in India, in 2002, Roche Diagnostics has seen formidable growth. Wide innovative product portfolio, superior quality of systems and reagents, strong service support and the people at Roche have been the drivers of growth.
What challenges has it faced in your growth story in India and how did you overcome them?
Roche Diagnostics has faced its share of challenges. The prime ones being at the awareness, infrastructure and service level. The challenge was to build upon an unknown brand based on past successes, global network and intense customer interaction. Considering the infrastructure of India and the importance of our life-saving products, we have created hubs and offices in all four metros to ensure timely availability. As for the service aspect, we tried to maximise uptime of systems in smaller places by training a large group of service people.
Please share details about functioning of your five distinct business units.
Structured around the customer and their needs, Roche Diagnostics India comprises five business areas namely applied science, molecular diagnostics, professional diagnostics, tissue diagnostics and diabetes care. Under 'professional diagnostics' we have centralised diagnostics, near patient testing, cardiac and professional services.
Name some of the innovations that the company has introduced in each of its business units
Under the umbrella of Roche Molecular Diagnostics, we have:
The Cobas S 201 system: It is a complete Nucleic Acid Testing (NAT) solution able to meet both current and future needs of blood screening labs. It provides blood screening labs the confidence and efficiency of extensively proven real-time PCR technology for HIV, HBV and HCV, highly reliable and robust modular automation, convenient ready-to-use reagents, and future menu expansion on the same validated system. Future assay developments will utilise multi-channel capabilities, providing real-time discrimination of major viruses. The system is backed by world-class service and strong local support.
K-Ras mutation test: This is a test that reveals the K-RAS genetic status of a patient to determine whether they will respond to certain therapies for the treatment of colorectal cancer. K-RAS mutations are frequently found in human cancers, and occur in 35- 45 per cent of meta-static colorectal cancer patients. According to the WHO, more than 6, 70,000 people die from colorectal cancer every year, making it the third most deadly cancer in the world. This will save lives and reduce costs Under the wing of Centralised Diagnostics we have,The Cobas® 6000 analyser series: It offers tailor-made solutions to medium-to-large workload laboratories. Flexible combinations of clinical chemistry (Cobas C 501 module) and Immunochemistry testing (Cobas e 601 module) modules are available.
Cobas IT solutions: Offering a wide range of IT-solutions from powerful, convenient and flexible point-of-care IT solutions to laboratory Information Systems (LIS) for the whole lab testing process.
Cystanin C: A reliable marker for early detection of chronic kidney disease. Concentrations of Cystatin C increases during kidney dysfunction. Cystatin C is described as a superior marker to serum creatinine for Glomerular Filtration Rate (GFR) assessment.
Anti-CCP assay: Detects the CCP antibodies, which are only in the blood of patient with Rheumatoid arthritis.
Procalcitonin (PCT) IL-6: Among the newest bio-markers for sepsis, Procalcitonin has the highest diagnostic accuracy. IL-6 is the earliest known marker for sepsis.
As far as the 'Roche Applied Science' wing goes, we provide, Genome Sequencer FLX System: The next generation Genome Sequencer FLX System provides the flexibility to perform the broadest range of applications possible using one sequencing system. It can sequence the whole human genome within a few days.
It is for research purpose only.
xCELLigence system: This is a micro-electronic biosensor system for cell-based assays, providing dynamic, real-time, label free cellular analysis for a variety of research applications in drug development, toxicology, cancer, medical microbiology and virology. This pioneering technology allows researchers to increase productivity and exceed the limits of endpoint analysis by capturing data throughout the entire time course of an experiment and obtaining more physiologically relevant data.
NimbleGen Sequence Capture: This technology is a revolutionary process for the enrichment of several megabases of selected genomic regions from full-complexity human genomic DNA in a single step. The process utilises high-density, long-oligo NimbleGen arrays for the targeted hybridisation and elution of only those genome regions that you specify. The method is applicable to large contiguous or non-contiguous genomic regions, whole exomes, or any other targeted regions you want to sequence.
Finally our 'Roche Tissue Diagnostics' consists of the BenchMark XT system: This allows a large improvement in operational flexibility, including the ability to process IHC, ISH, FISH and FITC tests, independently or simultaneously.
Please share some details on your plans for in-vitro diagnostics business.
Recently we took over Ventana, now Roche Tissue Diagnostics to offer a broader portfolio of IVD and differentiate from competition. It is specialised in histology testing. This permits to further put into practice our strategy of 'personalised healthcare'.
What's the USP of the company?
The unique functioning synergy between pharmaceuticals and diagnostics permits personalised healthcare- fitting the treatment to the patient. With this, Roche strives to achieve on best patient outcomes and lower costs.
Please elaborate on the MoU that you have signed with Genome Foundation.
Eighty per cent of clinical decision making is based on laboratory diagnostics. Our endeavour is to enable access of modern laboratory diagnostics to all segments and regions of India. Therefore, Genome Foundation and Roche have decided to join hands toward achieving this goal together. Further, there is little knowledge of epidemiology and genetic factors predisposing to common diseases such as diabetes, cardiovascular, etc in India. As India is the cardiovascular and diabetes capital of the world, we must embark upon an understanding of these problems in the Indian context.
How much do you spend on R&D?
Roche spends more than 8 billion Swiss Francs (Rs 36,000 crore) on R&D and employs over 7,000 people in R&D worldwide. A unique R&D network model between diagnostics and pharmaceuticals and strong alliances with companies, universities and research institutions worldwide give our scientists broadest access to innovation.
How has recession impacted the company?
From time immemorial, the healthcare industry has been less prone to recession. According to the University of Georgia's Georgia Economic Outlook 2002, 'Health services typically are viewed as necessities, which consumer is very reluctant to forgo or postpone even during hard times'. Roche, due to its innovation, has been growing faster than the market conditions, both globally and in India.
Which new products/ tests are in the pipeline?
There are new for biomarker for pre-eclampsia, K-RAS marker for cancer and EGFR.
What is the road ahead?
We aim to get a strong footprint in India by innovating processes staying ahead of the competition, improving customer satisfaction and innovative products and best people.
http://www.expresshealthcaremgmt.com/200906/labwatch09.shtml
Life-saving drugs under threat in Thailand
Thailand's national HIV and AIDS treatment program has succeeded in providing cheap drugs to 90 per cent of the people who need them.
However, the US push for a Free Trade Agreement with Thailand threatens the future of the treatment program by enforcing stricter patent rules. This could increase the price of new and improved AIDS drugs by as much as 90 per cent, costing the Thai government up to $ 3.2 billion and putting thousands of lives at risk.
For Solada (not her real name), the availability of affordable medicines is a matter of life or death. She is 43-years-old and HIV-positive. She is currently receiving medicine through the government treatment programme. She lives with her husband, Utai, who is a casual laborer, and her 16-year-old son, Putipong. Sewing bags for a living, she is the family's main breadwinner. "When I first learned I was HIV-positive I couldn't accept it,” she says. “But now, because of the treatment I receive, I feel alive. I'm born again."
Experts say that about five per cent of drug recipients each year develop resistance, as the HIV virus mutates. When this happens, new and improved drugs are required. These medicines are expensive as they are patented by international drug companies. The current prices charged by companies for these drugs ($6,782) are more than ten times the cost of cheaper copies currently provided by the government ($482). If the US and pharmaceutical companies get their way, life-saving drugs will be priced out of the reach of Thailand's poor people.
Isra (not his real name) is a 34-year-old dried seafood retailer living with HIV. Without support from Oxfam, he would be unable to pay for his HIV treatment, which costs twice what he earns per month. “I want drug companies to make drugs affordable,” he says. “The new drugs are expensive. I think they should also be part of the government programme, as people on my income can't afford to buy them. I get depressed and stressed when I think of it. I have no choice, I want to survive. I need these drugs."
Source:
The economics of effective AIDS treatment: evaluating policy options for Thailand (World Bank; 2006), by Ana Revenga, Mead Over, Wiwat Peerapatanapokin, Sombat Thanprasertsuk, Emiko Masaki, Viroj Tangcharoensathien, Julian Gold.
3 million now receiving life-saving HIV drugs
But access to prevention and treatment still lacking for millions
2 JUNE 2008 | GENEVA/PARIS -- The close of 2007 marks an important step in the history of the HIV/AIDS epidemic. Nearly 3 million people are now receiving anti-retroviral therapy (ART) in low- and middle-income countries, according to a new report jointly launched today by WHO, UNAIDS and UNICEF.
Towards universal access: scaling up priority HIV/AIDS interventions in the health sector (full report) |
The report, Towards universal access: scaling up priority HIV/AIDS interventions in the health sector, also points to other gains. These include improved access to interventions aimed at preventing mother-to-child transmission of HIV (PMTCT), expanded testing and counseling, and greater country commitment to male circumcision in heavily affected regions of sub-Saharan Africa.
“This represents a remarkable achievement for public health,” said WHO Director-General Dr Margaret Chan. “This proves that, with commitment and determination, all obstacles can be overcome. People living in resource-constrained settings can indeed be brought back to economically and socially productive lives by these drugs.”
Millions now accessing treatment
According to the authors of the report, the close of 2007 saw nearly 1 million more people (950 000) receiving antiretroviral therapy—bringing the total number of recipients to almost 3 million. The latter figure was the target of the ‘3 by 5’ initiative that sought to have 3 million HIV-positive individuals living in low-and middle-income countries on treatment by 2005. Although that target was not achieved until two years later, it is widely credited with jump-starting the push towards ART scale-up.
According to the report, the rapid scale-up of ART can be attributed to a number of factors, including the:
- Increased availability of drugs, in large part because of price reductions;
- Improved ART delivery systems that are now better adapted to country contexts. The WHO public health approach to scale-up emphasizes simplified and standardized drug regimens, decentralized services and judicious use of personnel and laboratory infrastructure; and
- Increased demand for ART as the number of people who are tested and diagnosed with HIV climbs.
Greater access: greater need
The authors state that overall, some 31% of the estimated 9.7 million people in need of ART received it by the end of 2007. That means that an estimated 6.7 million in need are still unable to access life-saving medicines.
“This report highlights what can be achieved despite the many constraints that countries face and is a real step forward towards universal access to HIV prevention, treatment care and support,” said Dr Peter Piot, Executive Director of UNAIDS. “Building on this, countries and the international community must now also work together to strengthen both prevention and treatment efforts.”
Preventing HIV in children
At the end of 2007, nearly 500 000 women were able to access antiretrovirals to prevent transmission to their unborn children — up from 350 000 in 2006. During the same period, 200 000 children were receiving ART, compared to 127 000 at the end of 2006. The difficulty of diagnosing HIV in infants, however, remains a major impediment to progress.
“We are seeing encouraging progress in the prevention of HIV transmission from mother to newborn,” said UNICEF Executive Director Ann M. Veneman. “The report should motivate us to focus and redouble our efforts on behalf of children and families affected by HIV/AIDS.”
Tuberculosis, weak healthcare systems, hamper progress
Other obstacles to scaling up treatment include poor patient retention rates in many treatment programmes and the considerable numbers of individuals who remain unaware of their HIV status, or are diagnosed too late and die in the first six months of treatment.
Tuberculosis is a leading cause of death among HIV-infected people worldwide, and the number one cause of death among those living in Africa. To date, HIV and TB service deliveries are insufficiently integrated and too many people are losing their lives because they are unable to either prevent TB or access life-saving medications for both diseases.
The authors warn that future expansion of access to ART is likely to be slow owing to weak health systems in the worst-affected countries, in particular, the difficulty of training and retaining health-care workers. Health-care systems in regions hardest hit continue to erode because of ‘brain drain’—the migration of skilled health-care personnel to other occupations and to other countries—and to high mortality rates from HIV itself.
They also emphasize the ongoing need to improve the collection, analysis and publication of critical public health information. Countries, international partners and other sources supply the numbers featured in this report. Despite certain limitations, the data constitute the best and most up-to-date estimates of the different elements of the health sector response to HIV/AIDS.
For further information please contact:
In Geneva:
WHO
Patricia Leidl
Telephone: +41 22 791 5876
Mobile: +41 79 619 8525
E-mail: leidlp@who.int
UNAIDS
Sophie Barton-Knott
Telephone: +41 22 791 1697
E-mail: bartonknotts@unaids.org
In New York:
UNICEF
Najwa Mekki
Telephone: +1 212 326 7162
E-mail: nmekki@unicef.org
Mark Aurigemma
Telephone: +1 212 600 1960
Mobile:+1 646 270 9451
E-mail: mark@aucomm.net
In London:
Claire Hoffman
Telephone: +44 20 8892 5215
E-mail: claire.hoffman@bartley-robbs.co.uk
Cathy Bartley
Telephone: +44 20 8694 9138
E-mail: cathy.bartley@bartley-robbs.co.uk
In Paris:
Michel Aublanc
Telephone:+33 1 69 286 286
E-mail: michel.aublanc@wanadoo.fr
European Heart Journal Advance Access originally published online on March 11, 2005
European Heart Journal 2005 26(9):858-860; doi:10.1093/eurheartj/ehi219
Substandard life-saving drugs: a global concern
Felicita Andreotti* and Filippo CreaInstitute of Cardiology, Department of Cardiovascular Medicine, Catholic University, Largo F. Vito 1, 00168 Rome, Italy
* Corresponding author. Tel: +39 6 30154187; fax: +39 6 3055535. E-mail address: felicita.andreotti@iol.it
This editorial refers to ‘Comparative analysis of the activity and content of different streptokinase preparations’ by P. Hermentin et al., on page 933
How can consumers and health professionals be sure that the drugs they use are safe and effective? A drug that has been approved for clinical use has undergone thorough evaluation during ‘phase I’ studies (pre-clinical and dose-finding) and during ‘phase II’ and ‘phase III’ randomized trials that test defined regimens of the new drug against a reference treatment in medium and large patient-year groups. This well-codified process provides information on the short- and mid-term safety and efficacy of the drug and forms the basis for approval by regulatory authorities. However, once the medication reaches the open market, it is more difficult to carry out a systematic and long-term evaluation. In this phase (‘phase IV’), pharmaceutical assessment relies on a combination of government-sponsored vigilance, spontaneous reports, and epidemiological monitoring.
The sensational withdrawal of rofecoxib (dictated by a significant increase in the incidence of myocardial infarction and stroke) as late as 5 years after its approval has raised questions concerning contemporary methods of monitoring the long-term safety of available drugs.1–3 Indeed, some of the present measures of phase IV surveillance contain internal conflicts that hinder the very actions they are meant to perform. For instance, current regulations provide for the withdrawal of a drug by the same agency that approved its initial marketing or for the report of drug-related adverse events by the manufacturer of the drug itself.1 These arrangements do not favour impartial decisions, as they entail that the agency be ready to recognize its own failure and that the company voluntarily limit its income.1 Greater awareness of these pitfalls is prompting external and independent assessments of marketed pharmaceuticals in order to improve drug safety.1
But there is still another, largely neglected aspect of post-marketing control aimed at curbing the manufacture and trade of substandard or counterfeit medications. This form of vigilance should check the drug's identity, chemical integrity, physical stability, and biological activity, and exclude the possible damaging effects of inappropriate handling, packaging, and storage. Counterfeit or substandard medicines are more common in developing countries,4,5 where disease burdens are high and public resources insufficient to ensure effective monitoring. The magnitude of the phenomenon is considerable. Indeed, the World Health Organization (WHO) estimates that up to 10% of the world's drug trade—25% in developing countries—consists of fakes that are sold around the world.4,5 Drugs that treat serious diseases such as malaria, tuberculosis, autoimmune deficiency syndrome (AIDS), or other infections are more often the object of counterfeits.4,6 In the Democratic Republic of Congo, a country plagued by both civil war and AIDS, antidepressant medications are sold as antiretroviral drugs.6 The origin of these frauds is either local or from external countries, reflecting—in the latter case—international networks of illegal trade and drug supply.5 Control of this phenomenon clearly constitutes a global challenge.
Streptokinase (SK) belongs to one of a few dozen contemporary groups of life-saving drugs. It is used to treat one of the most common and suddenly fatal maladies of our society: acute myocardial infarction (AMI). Evidence that this bacteria-derived fibrinolytic agent given intravenously to patients with AMI reduced deaths and myocardial dysfunction, compared with placebo, came about almost 20 years ago.7 Nowadays, optimal treatment of patients with AMI calls for primary percutaneous coronary interventions, but intravenous thrombolysis is ‘next best’ whenever interventional cardiology is not available. SK compared with alteplase causes fewer intracranial haemorrhages8 and is 5–10 times less expensive than the newer lytic agents. Thus, despite evidence of a slightly lower efficacy when compared with the ‘accelerated’ alteplase dosing, SK ranks among WHO's essential medications.9 As for all lytics, the narrow therapeutic range of SK reflects a fine balance between its efficacy, in terms of coronary recanalization, and the risk of causing major bleeds. Strict calibration of the protein's activity is mandatory and must be stated in the manufacturer's label.
Hermentin et al.9 (from Aventis Behring GmbH) compare the in vitro fibrinolytic activity of 16 different SK preparations available on the world market. In five cases, the same commercial product was tested from two different batches, yielding a total of 21 evaluations. The merchandise was produced by 11 manufacturers (including Aventis Behring) based in six countries: Korea, Germany, Sweden, India, China, and Cuba. Three packages were labelled as recombinant. One distributor was European, whereas the other 16 were located in India, Pakistan, Brazil, China, and Jordan. The fibrinolytic activity of each sample was measured by an in vitro, soluble-phase, chromogenic-substrate assay, calibrated against a WHO SK international standard.
Astonishingly, only three of the 21 formulations (14.3%) are reported to have activities between 90 and 111% of the value declared on the label, in accordance with the minimum requirements of the European pharmacopoeia.9 The activities of the other 18 are ranked <90%, with eight <50%, and the three recombinant preparations <40%. The authors then compared the migration pattern of each product on native and reducing sodium dodecyl sulfate polyacrilamide gel electrophoresis. The results suggest variations in the ratio between SK and its stabilizer (human albumin) and heterogeneity in the region attributable to SK, presumably caused by impurities, chemical alteration, or protein degradation. For six preparations that showed an abnormal migration pattern in the SK region, sequencing of the 15 N-terminal amino acid residues is reported to produce sequences coinciding with that of Streptococcus pyogenes SK in only two cases.
A methodological drawback of the work by Hermentin et al.9 (which the authors acknowledge) is the assessment of only one sample per batch of SK, limiting the generalizability of the results. Moreover, the authors have a direct interest in publicizing their findings, as the SK formulation produced and distributed by their employer showed an exemplary profile in their analyses. Despite these limits, the data by Hermentin et al.9 appear reliable, as they are supported by another report, from an independent academic institution, using rigorous methods of analysis, which also describes marked differences in the activity of five commercially available SK formulations.10
How does one tackle the problem of substandard medications? It has been argued that increasing the awareness of poor quality drugs may cause patients to worry excessively about whether the medicines they are taking are genuine.5 On the other hand, lack of vigilance may generate a lack of trust in both consumers and professionals.1 Bringing the issue of substandard medications to public attention—as the article by Hermentin et al. does—is an essential first step towards reinforcing current methods of surveillance. A further indispensable step is to accept that the problem of counterfeit drugs really exists and to recognize it without embarassement. Finally, several actions, adapted to the local needs, should be discussed. They include: (i) exchanging information and establishing collaborations between national and international organizations (e.g. WHO and Interpol) that control marketed drugs;11 (ii) informing consumers and health professionals of the risks of counterfeits and providing them with simple instructions (e.g. the telephone number of a national agent) to report suspect cases;11 (iii) labelling medications with radio frequency or other unique identification tags to trace the drug from the point of manufacture to the point of dispensing;11 (iv) improving the inspection of all steps of the drug distribution chain, from manufacturers to consumers; (v) performing regular chemical analyses on local and imported products; (vi) requesting that the method(s) used to assess a drug's activity be stated on the product label; (vii) stricter licensing requirements for drug distributors;11 (viii) introducing tougher penalties against illegal drug manufacture and distribution;11 (ix) replacing procedures favouring self-denial (in this case, the report of counterfeit medications by agencies responsible for controlling fraud) with external and independent quality assessements of marketed drugs; and (x) making national government funds available through the WHO to fight poor quality drugs within individual countries.4
The presence of counterfeit or substandard drugs on the world market represents a serious problem, particularly in the case of life-saving medications used to treat common diseases. When administered correctly and promptly, an effective dose of SK can reduce the risk of dying of AMI by >25% when compared with placebo.7 AMI can strike suddenly, unpredictably, indiscriminately, in one's own country, and when travelling abroad. Regardless of whereabouts, it would be a pity if emergency treatment were useless. Getting this right is a global responsibility.
Footnotes
References
- Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance—lack of vigilance, lack of trust. JAMA 2004;292:2647–2650.[Free Full Text]
- Topol EJ. Rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707–1709.[Free Full Text]
- Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G, Shoor S, Ray WA. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005;365:475–481.[ISI][Medline]
- Pincock S. WHO tries to tackle problem of counterfeit medicines in Asia. BMJ 2003;327:1126.[Free Full Text]
- Gibson L. Drug regulators study global treaty to tackle counterfeit drugs. BMJ 2004;328:486.[Free Full Text]
- Ahmad K. Antidepressants are sold as antiretrovirals in DR Congo. Lancet 2004;363:713.[Medline]
- Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1986;22:397–402.
- Simoons ML, Maggioni AP, Knatterud G, Leimberger JD, de Jaegere P, van Domburg R, Boersma E, Franzosi MG, Califf R, Schroder R. Individual risk assessment for intracranial haemorrhage during thrombolytic therapy. Lancet 1993;342:1523–1528.[CrossRef][ISI][Medline]
- Hermentin P, Cuesta-Linker T, Weisse J, Schmidt KH, Knorst M, Scheld M, Thimme M. Comparative analysis of the activity and content of different streptokinase preparations. Eur Heart J 2005;26:933–940. First published on January 6, 2005, doi:10.1093/eurheartj/ehi093.[Abstract/Free Full Text]
- Couto LT, Donato JL, de Nucci G. Analysis of five streptokinase formulations using the euglobulin lysis test and the plasminogen activation assay. Braz J Med Biol Res 2004;37:1889–1894.[Medline]
- Anon. Protecting consumers from counterfeit drugs. FDA Consumer magazine 2004;38:12–13.
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Comparative analysis of the activity and content of different streptokinase preparations Peter Hermentin, Thomas Cuesta-Linker, Joerg Weisse, Karl-Heinz Schmidt, Marion Knorst, Michael Scheld, and Michael Thimme
EHJ 2005 26: 933-940. [Abstract] [FREE Full Text]
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EU must stop destroying life-saving drugs in transit
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- http://www.europeanvoice.com/article/imported/eu-must-stop-destroying-life-saving-drugs-in-transit/64337.aspx
Kidney cancer patients denied life-saving drugs by NHS rationing body NICE
By Daily Mail Reporter
Last updated at 12:55 AM on 29th April 2009
Thousands of kidney cancer patients are likely to lose out on life-prolonging drugs.
The NHS rationing body, NICE, has confirmed a ban on three out of four new treatments.
It has reversed its position on just one, Sutent, which will now be allowed for patients with advanced cancer.
NICE has the last say on which drugs are administered by the NHS
But campaigners who fought NICE's original blanket ban said this was not enough. They said some patients with heart problems cannot tolerate Sutent.
Kate Spall, head of the Pamela Northcott Fund campaign group, said the ruling meant that fewer than half of newly diagnosed patients would be eligible for therapy.
She added: 'Families will be denied time together and doctors will be unable to give patients the best treatment.'
Campaigners are angry that NICE appears to have ignored new official guidelines widening access to life-prolonging drugs.
Sutent, also known as sunitinib, can double the life expectancy of patients, to 28 months, compared with standard interferon treatment. It costs around £24,000 a year.
The rejected drugs - bevacizumab (Avastin), sorafenib (Nexavar) and temsirolimus (Torisel) - have similar costs and are used in other countries.
Nicole Farmer, of Bayer Schering Pharma Oncology, which makes Nexavar, said: 'This shows why the UK sits 16 out of 18 EU countries with regard to cancer outcomes'.
Dr Thomas Powles, Clinical Senior Lecturer, at Barts and The London NHS Trust, said the 'one size fits all' policy would disadvantage many of the 7,000 patients diagnosed each year with kidney cancer.
He said: 'This one dimensional approach will leave some patients without potentially beneficial treatments, indeed some patients will not be eligible for any effective treatments whatsoever.'
Stella Pendleton, executive director of the Rarer Cancers Forum, said: 'This decision contradicts the spirit of the recommendations made by Professor Mike Richards on improving access to medicines for NHS patients, and highlights flaws in the current system for appraising drugs.
'We call on Nice to reverse this decision.'
http://www.dailymail.co.uk/health/article-1174592/Kidney-cancer-patients-denied-life-saving-drugs-NHS-rationing-body-NICE.html
CROW AGENCY, Mont. -- Ta'Shon Rain Little Light, a happy little girl who loved to dance and dress up in traditional American Indian clothes, had stopped eating and walking. She complained constantly to her mother that her stomach hurt.
When Stephanie Little Light took her daughter to the Indian Health Service clinic in this wind-swept and remote corner of Montana, they told her the 5-year-old was depressed.
Ta'Shon's pain rapidly worsened and she visited the clinic about 10 more times over several months before her lung collapsed and she was airlifted to a children's hospital in Denver. There she was diagnosed with terminal cancer, confirming the suspicions of family members.
A few weeks later, a charity sent the whole family to Disney World so Ta'Shon could see Cinderella's Castle, her biggest dream. She never got to see the castle, though. She died in her hotel bed soon after the family arrived in Florida.
"Maybe it would have been treatable," says her great-aunt, Ada White, as she stoically recounts the last few months of Ta'Shon's short life. Stephanie Little Light cries as she recalls how she once forced her daughter to walk when she was in pain because the doctors told her it was all in the little girl's head.
Ta'Shon's story is not unique in the Indian Health Service system, which serves almost 2 million American Indians in 35 states.
On some reservations, the oft-quoted refrain is "don't get sick after June," when the federal dollars run out. It's a sick joke, and a sad one, because it's sometimes true, especially on the poorest reservations where residents cannot afford health insurance. Officials say they have about half of what they need to operate, and patients know they must be dying or about to lose a limb to get serious care.
Wealthier tribes can supplement the federal health service budget with their own money. But poorer tribes, often those on the most remote reservations, far away from city hospitals, are stuck with grossly substandard care. The agency itself describes a "rationed health care system."
The sad fact is an old fact, too.
The U.S. has an obligation, based on a 1787 agreement between tribes and the government, to provide American Indians with free health care on reservations. But that promise has not been kept. About one-third more is spent per capita on health care for felons in federal prison, according to 2005 data from the health service.
In Washington, a few lawmakers have tried to bring attention to the broken system as Congress attempts to improve health care for millions of other Americans. But tightening budgets and the relatively small size of the American Indian population have worked against them.
"It is heartbreaking to imagine that our leaders in Washington do not care, so I must believe that they do not know," Joe Garcia, president of the National Congress of American Indians, said in his annual state of Indian nations' address in February.
http://www.washingtonpost.com/wp-dyn/content/article/2009/06/14/AR2009061400903.html?hpid=sec-health?hpid=sec-health
Arizona / West
Medical tourism keeps growing
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3:30 pm: The Nifty closed sharply lower on Monday, down 80.45 points or 1.76% at 4502.95. The 50 share index barely managed to hold the 3:00 pm: CG Impex Ltd has recommended for approval of the shareholders, rights issue of equity shares in the ratio of three equity shares of Rs 10 each for every one share held as on a Record Date to be fixed later for this purpose. Despite this, shares of the company were down 1.51% at Rs 5.89 on BSE. 2:30 pm: Aurobindo Pharma Ltd has received approval for Amlodipine Besylate Tablets 5mg and 10 mg from Therapeutic Goods Administration of Australia. Amlodipine Besylate tablets fall under the central nervous system therapeutic segment and is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in majority of patients. 2:07 pm: Tata Consultancy Services ltd has launched Provider Performance Insight, a business intelligence solution build on SAP BusinessObjects software for hospitals and other healthcare providers. Using its proprietary BI framework, TCS has developed an out-of-the-box dashboard that will simplify projects, reduce costs and dramatically shorten time to value related to both hospital administration and patient care. On NSE, shares of the IT major were up 0.33% at Rs 767.05. 1:25 pm: India Infoline has advised investors to go long on Cipla June future at Rs 252. “Go long on Cipla June future at Rs 252 for the target price of Rs 268 and keep stoploss placed at Rs 248. Lot size: 1,250 Remarks: Net maximum profit of Rs20,000 and net maximum loss Rs5,000,” said India Infoline report. 1:04 pm: 3i Infotech Ltd has announced its entry into the Media & Broadcasting industry as a System Integrator and will offer a unique value proposition to media and broadcasting companies, with best-of--the-breed products from leading global Media & Broadcast solution vendors, complemented with the company's own expertise in System integration and Project Management Services. Shares of the company were up 1.24% at Rs 85.50 on the BSE. 12:54 pm: AXIS Bank Ltd has decided to close its issue of Unsecured Redeemable Non-Convertible Subordinated Debentures (Lower Tier II Debentures) of Rs 10,00,000 each aggregating to Rs 2,000 crores (Rs 1,500 crores plus Green Shoe Option up to Rs 500 crores) today. The date of allotment / deemed date of allotment would be June 16, 2009. Shares of the private sector bank were up 3.35% at Rs 727 on the BSE. 12:30 pm: NGL Fine Chem Ltd informs that on June 12, a fire broke out at its factory premises, cause of which is not yet ascertained. Most of the company's stock and machinery was burnt and destroyed due to the fire. The total value destructed has not been determined yet but is estimated at about Rs 150 lakhs. However, the unit is fully insured and the amount will be covered adequately under an insurance claim. The unit where this accident has occurred contributes to about 15% of the total production capacity that the company has spread over three locations. It is estimated that about 4-6 months will be required to commission a similar facility. The other units located at Tarapur are operational and continue to function normally. 11:16 am: Shares of Reliance Natural Resources surged over 22% to Rs 107.10 on BSE, after the Bombay High Court judged in favour of the company in the long-standing RIL-RNRL gas supply agreement dispute. By the gas supply master agreement, RIL was supposed to supply natural gas from the Krishna-Godavari basin to RNRL, to be used for the Anil Ambani group's power generation plant at Dadri in Uttar Pradesh. The GSMA came into existence in January 2006, following the demerger of the Reliance group. But both the sides differed on its terms related to the quantity of gas to be supplied, price, and duration of supply. The stock touched a high of Rs 107.70, inching close to the 52-week high of Rs 109.95 made on Aug 6, 2008. 11:12 am: LIC Housing Finance Ltd informs that the chairman, pursuant to power delegated in his favour by the board of directors, decided to sell to prospective investor/s 1730 equity shares of Rs.10,000 each of LIC Mutual Fund Asset Management Company Ltd. held by the company out of total holding of 3,930 equity shares. Similarly, the board has also decided to sell 2,000 equity shares of Rs.10 each of LIC Mutual Fund Trustee Company out of total holding of 3,600 equity shares. Further, the 100% subsidiary of LIC Housing Finance, namely, LICHFL Care Homes Ltd., which holds 1,200 shares of Rs.10 each of LIC Mutual Fund Trustee Company, will also be selling their full holding of equity shares.The price for the sale of stake will be decided mutually by all the parties involved. Shares of the company were up 1.54% at Rs 578.70 on the NSE. 11:05 am: Goldiam International Ltd informs that pursuant to the Voluntary Retirement Scheme announced by the company, further 182 employees have opted for voluntary retirement up to June 13, and have been relieved from the services. The company has, subsequently, closed the scheme. On the BSE, the company's share was down 4.33% at Rs 28.75. 11:03 am: Deep Industries Ltd has obtained extention of contract with GACL and Letter of Awards from ONGC aggregating to Rs 764.85 lakhs. 1. LOA From: GACL, Vadodara - Contract Value in Rs - 44.35 lakhs 2. LOA From: ONGC Assam Asset Contract Value Rs - 187.60 lakhs 3. LOA From: ONGC Rajahmundry Asset Contract Value in Rs - 532.90 lakhs On the BSE, shares of Deep Industries were up 5% at Rs 127.65 following this news. 10:34 am: Zylog Systems India Ltd has launched Wi5 wireless broadband services in Chennai. The WiFi services will enable customers to access high-speed wireless broadband connectivity through their laptops, desktops or mobile devices by subscribing to Wi5 services on the move. With this, Zylog enters the ISP business in the country and has obtained a category A internet service provider licenser to operate in all of India's DoT circles. On NSE, Zylog Systems shares were up 2.48% at Rs 186.10. 10:25 am: Era Infra Engineering Ltd has bought back Zero Coupon Convertible Bonds, due in 2012, of aggregate face value $2.1 million. Earlier, the company had bought back $16 million of FCCBs. On the NSE, Era Infra shares were down 2% at Rs 112.15. 10:21 am: Hindustan Dorr-Oliver Ltd has bagged a project worth Rs. 126.95 crores from HPCL- Mittal Energy Ltd for RO based DM plant of capacity 21 MLD. This will be executed on turnkey basis on High Efficiency Reverse Osmosis technology. This project will bring in additional qualification in HDO. Engineers India Ltd. will be the Project Management Consultants for the contract. Execution of the project shall be completed within a period of 13 months. Hindustan Dorr-Oliver shares were flat at Rs 88.90 on NSE, while the Nifty was down 1%. 10:19 am: Shree Renuka Sugars Ltd has increased its equity stake in one of its subsidiary companies, KBK Chem-Engineering Pvt. Ltd., Pune from 54% to 80.28%. KBK is an engineering company, primarily engaged in providing turnkey solutions in the field of distilleries, ethanol plants and bio-fuels. On NSE, shares of Shree Renuka Sugars were down 2.31% at Rs 137.25. 10:04 am: The gainers among the 50 Nifty stocks included Suzlon Energy (1.81%), Ranbaxy Laboratories (1.77%), Infosys Technologies (1.71%), Tata Consultancy Services, Wipro, BHEL, State Bank of India, ACC, Reliance Power, Ambuja Cements. 10:02 am: The biggest losers in the Nifty were Sterlite Industries (-5.83%), SAIL (-2.82%), Hindalco Industries (-2.68%), Tata Motors, Mahindra & Mahindra, Tata Power, Tata Steel, Larsen & Toubro, Reliance Infrastructure, Hero Honda Motors. 10:01 am: The Nifty started the week flat and soon turned weak. The NSE index opened at 4584.65 against Friday's close of 4583.40. The 50 share index moved from an initial 4584.75 to 4522.95. It settled at 4538.25, down 45.15 points or 0.99%. |
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7 students test positive for swine flu, total up to 30Times of India - 30 minutes ago 15 Jun 2009, 2004 hrs IST, PTI NEW DELHI: Seven students in Jalandhar, who returned from the United States, tested positive for swine flu, taking the total number of people affected by the virus across the country to 30 even as Union Health Minister ... 2.86 lakh incoming passengers screened for A(H1N1) fluHindu - 20 hours ago CHENNAI: Only two cases of A(H1N1) flu have been confirmed since the health authorities launched a 40-day-old vigil against the A (H1N1) virus during which over 2.86 lakh incoming passengers were screened at international airports and ports, ... 5-member family from US quarantined in city Times of India Five of family quarantined, discharged later TheMedGuru Swine flu: Beef up security, hospitals toldTimes of India - 15 hours ago NEW DELHI: Following TOI's report on Sunday about a 38-year-old swine flu suspect slipping out of Ram Manohar Lohia Hospital's isolation ward, Delhi government has asked hospitals to make adequate security arrangements to avoid a repeat of such ... 55 Children Fall Ill After Dead Snake Turns Up in Mid-day MealMedIndia - Jun 13, 2009 In yet another indictment of the poor facilities provided to schools asked to serve mid-day meals, fifty-five school children have fallen ill after a dead snake turned up in their food. 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Woman tested negative of flu in Pune TheMedGuru Pune's first swine flu patient? Mid-Day H1N1 ruins holiday of mother, daughterTimes of India - 19 hours ago Bangalore : She landed in Bangalore along with her daughters for a vacation in her mother's house. And she didn't realize that the persistent cold she brought from New Jersey could lead to H1N1 flu. Two cases of H1N1 flu confirmed in Bangalore Times Now.tv Two swine flu patients under treatment in Bangalore Thaindian.com Naps With Rapid Eye Movement Sleep Increase Receptiveness To ...MedIndia - Jun 13, 2009 Naps with rapid eye movement (REM) sleep refresh the brain's empathetic sensitivity for evaluating human emotions by decreasing a negative bias and amplifying recognition of positive emotions, according to a research abstract that will be presented on ... Sleep on this at your own risk Hindustan Times Sleep duration linked to weight gain Times of India Massive Hair Lump Removed From Girl's StomachMedIndia - 9 hours ago Chandan Bariya of Sankariya village of Limkheda Taluka was brought to the clinic of Samir Brahmbhat after complaining of severe abdominal pain. One kg hair lump removed from girl's stomach TheMedGuru Docs discover 1 kg hair in girl's gut Times of India Results out. What next?Times of India - 13 hours ago NAGPUR: After the all important results of MHT-CET are out, now all eyes will be on admissions process to begin as it is the single exam for admissions to health sciences, engineering, pharmacy and veterinary sciences courses (BVSc and AH). Doctor-state tussle likely to worsen PG seat crisis Daily News & Analysis Dip in students eligible for medical colleges Indian Express Delhi HC to lower courts: Finish trials in 3 yearsTimes of India - 18 hours ago NEW DELHI: With the capital's session courts running a backlog of almost 66000 cases, the Delhi High Court has directed all lower courts to fix a timeframe of three years for deciding trial of each case. Push for time-bound disposal of cases Calcutta Telegraph Shutdown notice to DPL plantTimes of India - Jun 13, 2009 KOLKATA: The Durgapur Projects Limited is yet again in a spot. The West Bengal Pollution Control Board has slapped a "shut down" notice to its coke oven plant. Green rap for DPL Calcutta Telegraph India's HIV victims find solace in marriageAFP - 11 hours ago AHMEDABAD, India (AFP) - Taking medicines on time is a big part of a successful marriage for Ravi and Nima -- an HIV-positive couple who met as a direct result of the enduring stigma attached to AIDS in India. How one newspaper thinks positive MorungExpress The new face of HIV Sun newspapers No Basis for Fingerprint Grip TheoryMedIndia - Jun 13, 2009 The popular fingerprint grip theory, which held that they help improve grip by increasing friction between people's hands has been disproved, scientists have claimed. Fingerprint grip theory rejected BBC News Fingerprints do not improve grip: Study TheMedGuru Millions unaware of red meat cancer riskTelegraph.co.uk - 7 hours ago Millions of people could be putting themselves at greater risk of cancer because of ignorance about the risks from red and processed meat, a study suggests. Global bowel cancer rates on the rise Cancer Research UK - News & Resources British men's "stiff upper lip" may be killing themReuters India - 5 hours ago LONDON (Reuters) - British men's "stiff upper lip" attitude which makes them reluctant to visit their doctors may be behind the fact that they are almost 40 percent more likely than women to die of cancer, according to research on Monday. Men More Likely To Die From Cancer Than Women In UK Medical News Today Ladette thugs new scourge of streetsMirror.co.uk - 9 hours ago By James Lyons 15/06/2009 New figures show binge-drinking is out of control among "ladettes" who appear to be trying to outdo their violent male counterparts in the thug stakes. Diet foods and snack bans could fuel binge eating, claimTelegraph.co.uk - 7 hours ago Diet foods and bans on sugary snacks could inadvertently fuel binge eating, two studies suggest. By John Bingham A team of experimental psychologists found evidence that some efforts to prevent obesity could have a counterproductive effect. Diet foods encourage overeating, study finds Independent Alzheimer's and the will to chooseHindu - Jun 13, 2009 “The person with dementia may lose all self awareness and with it, the sense of self identity. Enslaved in his own collapsing structure, a feeling of self does prevail which occasionally appears as lucid moments, where in figments he shows some ... |
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