Case involved Vermont musician who lost her arm to anti-nausea drug

In a long-awaited legal decision, the U.S. Supreme Court ruled Wednesday that patients who are injured by a drug can sue the drug’s manufacturer for damages, even if the drug has been granted FDA approval.

The decision, in the lawsuit Wyeth v. Levine, upheld $6.7 million in damages to a Vermont musician named Diana Levine who had to have her arm amputated after Wyeth’s Phenergan anti-nausea drug hit an artery and caused gangrene.

The complication is a rare one but is acknowledged on the drug’s labeling. Wyeth had argued that the U.S. Food and Drug Administration warning carried on the drug was sufficient.

At a press conference after the decision was announced, Levine, who was injured in April 2000, said: “I’m on the ceiling, I’m just so high about this, I’m so glad, it’s such a good decision and, next to getting my hand, it’s the best they could do, and it’s the least they could do. I’m in a state of almost shock and almost unrestrained joy.”

The court decision was hailed as a triumph by Public Citizen, a consumer watchdog group.

“It’s a terrific decision, because it understands both the importance of compensation for people who are harmed by defective or mislabeled drugs and also understands that the tort system is a complement to the federal regulatory system, that it is not an obstacle to that system,” said Brian Wolfman, director of the litigation group at Public Citizen in Washington, D.C.

Wolfman served as one of Levine’s attorneys.

Bert Rein, an attorney for Wyeth, said the company “fully complied with federal law” in its labeling, and that the FDA “is in the best position to weigh the risks and benefits of a medicine,” The New York Times reported.

In a news release, the Pharmaceutical Research and Manufacturers of America (PhRMA), said the group “is still reviewing the various opinions in the Wyeth v. Levine case. We continue to believe that the expert scientists and medical professionals at the Food and Drug Administration are in the best position to evaluate voluminous information about a medicine’s benefits and risks and to determine which safety information to include in the drug label.”

The high court’s decision is likely to unleash a torrent of similar lawsuits around the country.

“The court opinion not only declined to tell pharmaceutical companies that they could have this kind of immunity, it, in fact, pushed somewhat in the other direction,” said Benjamin C. Zipursky, professor of law at Fordham Law School in New York City and visiting professor at Harvard Law School in Boston.

“Some trial lawyers who had been hesitant to bring claims against pharmaceutical companies are now going to be more willing to do so,” Zipursky said. “A number of cases that were stayed in state and federal court pending this decision will now go forward and go forward with a more plaintiff-oriented posture. This is going to change the balance of incentives for lawyers who are thinking about suing pharmaceutical companies to make them more willing to sue and make trial judges and appellate courts less willing to throw out weak cases.”

Wolfman added: “In general, it’s going to mean that these claims are not pre-empted and that people with drug and injury claims are going to be able to sue for damages and get to a jury and, if the jury agrees, be compensated for that.”

The high court’s 6-3 decision essentially upended moves by the Bush administration to protect drug makers from lawsuits as long as the product was FDA-approved.

Many watchers had predicted that the court would decide the other way, Zipursky said.

“It was a surprise in two respects,” he said. People had believed “that whatever the court did, it would rule narrowly and, in fact, the decision is quite broad.”

Ascenta Therapeutics announced positive preliminary results from its Phase II study of AT-101 in combination with docetaxel and prednisone (D/P) in men with docetaxel refractory, castrate resistant prostate cancer (CRPC) at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in Orlando, FL. AT-101, an oral, pan-Bcl-2 inhibitor currently in double-blinded, randomized Phase II clinical trials in both prostate cancer and non-small cell lung cancer, is the lead compound in Ascenta Therapeutics’ portfolio of apoptosis-triggering small molecules.

“This is the first report of several we plan to present this year from a large and growing data set demonstrating the broad therapeutic potential of AT-101,” said Mel Sorensen, MD, CEO of Ascenta Therapeutics. “The evidence of resistance reversal from this refractory population supplements the earlier clinical data demonstrating robust activity with the same regimen in docetaxel-naive patients.”

Initial findings from the ongoing open-label, multi-center study demonstrates that AT-101 can be administered safely with D/P in these patients. Investigators also observed clinical responses, based on both PSA and RECIST criteria, including four patients with a confirmed PR (partial response, defined as a PSA decline of 50 percent or greater).

“This first look at the data is very encouraging, particularly since all of these patients were truly refractory to docetaxel, having not simply failed to respond but actually experienced disease progression during prior therapy,” said James Reeves, MD, principal investigator, Florida Cancer Specialists. “Our results to date suggest that stimulating cancer cell apoptosis through Bcl-2 pathways with AT-101 may in fact extend the clinical utility of docetaxel in this cohort of highly treatment-resistant patients.”

The analysis included data from 37 men with docetaxel-refractory CRPC who were treated with D (75 mg/m(2) q3 weeks), P (5 mg b.i.d. on days 1-21) and AT-101 (40 mg b.i.d. on days 1-3 of each 21-day cycle). Safety and efficacy were assessed at three-week intervals, with radiological assessments performed at 6-week intervals for patients with soft tissue disease and bone scans performed after cycle 6 and at completion of therapy. Ten of the 37 patients remain on study.

Thirty-eight percent (14/37) of patients treated had at least a 30 percent decrease in PSA level and 19 percent (7/37) achieved a confirmed PR. Twenty patients had measurable disease, five of whom (25 percent) had a PR by RECIST criteria, with additional patients eligible to achieve a response. Four patients have been on therapy for 6 months or more.

Safety data was available for 22 patients. The most common (10 percent or greater) adverse events included fatigue (50 percent), diarrhea (27 percent), nausea, anorexia, and neutropenia (all 23 percent), vomiting and dizziness (18 percent). The most common Grade 3/4 toxicity was neutropenia (23 percent) and was the only Grade 3/4 adverse event that occurred in more than two patients (5 patients). These adverse events were considered manageable and consistent with the safety profile of D/P.

Facts About Prostate Cancer

The American Cancer Society estimates that more than 186,000 new cases of prostate cancer were diagnosed in the United States and that more than 26,000 men died of the disease in 2008, making it the second leading cause of cancer deaths among American men after lung cancer. Approximately half of all patients with prostate cancer suffer recurrent, advanced disease after definitive local therapy with radiation or prostatectomy and systemic treatment. One process by which prostate cancers may develop resistance to systemic treatment is by increasing the expression of proteins that inhibit apoptosis (programmed cell death). The most recognized group of such proteins are the antiapoptotic members of the Bcl-2 family, including Bcl-2, Bcl-XL, and Mcl-1. Overexpression of Bcl-2 family proteins in human tumor specimens has been reported by several groups to be associated with recurrence, more advanced stage, treatment resistance, the development of hormone-resistance, and shortened survival in prostate cancer.

About AT-101

AT-101 is an orally-active, pan-Bcl-2 inhibitor (including Bcl-2, Bcl-xL, Bcl-w, and Mcl-1 inhibition), that has been shown to directly induce apoptosis by operating as a BH3 mimetic and indirectly as an independent upregulator of Noxa and Puma. By blocking the binding of Bcl-2 family members with proapoptotic proteins and upregulating specific proapoptotic factors, AT-101 lowers the threshold for cancer cells to undergo apoptosis in various tumor types. In Phase I and Phase II trials, AT-101 has demonstrated single-agent cytoreductive activity in chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma (NHL), and prostate cancer. Phase II combination trials are ongoing in hormone-refractory prostate cancer and non-small cell lung cancer (with Taxotere(R) [docetaxel]), B-cell malignancies (with Rituxan(R) [rituximab]), small cell lung cancer (with Hycamtin(R) [topotecan]), glioma (with Temodar(R) [temozolomide], +/- chemoradiotherapy [XRT]) and in esophageal cancer (with docetaxel, 5-fluorouracil and XRT). Recently, two double-blinded, randomized, controlled trials of the docetaxel + AT-101 combination were opened in hormone-refractory prostate cancer and non-small cell lung cancer, both indications in which docetaxel is approved as a single agent.

About Ascenta Therapeutics

Ascenta Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company that discovers and develops new medicines for the treatment of cancer. The company is headquartered in Malvern, Pennsylvania, and has a preclinical research facility in Shanghai, China. Its technology, licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan, is focused on discovering molecules that target proteins that prolong cell survival.

For additional information on Ascenta Therapeutics, including information on ongoing clinical trials with AT-101, please visit the company’s website at http://www.ascenta.com.

US scientists reviewing 20 years of research and expert opinion on generic versus brand name drugs in the treatment of cardiovascular diseases found no clinical evidence showing brand names were superior to generic versions even though a substantial number of experts writing editorials advised against interchanging them.

The study was the work of Dr Aaron S Kesselheim, of Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, and colleagues, and is published online in the 3rd December issue of the Journal of the American Medical Association, JAMA.

When two drugs are bioequivalent it means that to all intents and purposes after they have been given to the patient they are biologically equivalent to each other, for example the composition, rate and extent to which their active ingredients are present at the target site inside the body are so similar that you can’t tell the difference between them.

And yet there appears to be a general opinion among doctors and patients that despite the fact generic drugs are bioequivalent to brand name drugs, the brand names are clinically superior. But generic drugs are much cheaper, so Kesselheim and colleagues decided to investigate the available clinical evidence on generics versus brand names and the views of editorial writers on the subject with respect to cardiovascular treatments.

For the study, the researchers systematically searched for peer reviewed studies published between 1984 and 2008 and listed in a number of well known databases, including MEDLINE, EMBASE, and International Pharmaceutical Abstracts.

They selected those studies that compared the clinical effectiveness and safety of generic versus brand name cardiovascular drugs. In a separate exercise they also identified editorials that wrote about substituting brand names with generic versions.

Kesselheim and colleagues then used techniques commonly used in research that reviews other studies, whereby the design, setting, participants, results and funding of each study is extracted and put through a test that assesses the quality of the trial, whilst the results are pooled in such a way that they can then be viewed as if they had come from one giant trial (meta-analysis).

As a separate exercise they reviewed the editorials and classified them as negative, positive or neutral, depending on the authors’ view on generic substitution.

They found a total of 47 clinical trials covering 9 subclasses of cardiovascular drugs, and established the following results:

* 38 of the 47 (81 per cent) trials were randomized controlled trials (considered to be higher quality).

* For beta-blockers, 7 out of 7 randomized controlled trials (100 per cent) found generics to be clinically equivalent to brand names.

* For diuretics, the figure was 10 out of 11 (91 per cent).

* For calcium channel blockers it was 5 out of 7 (71 per cent).

* For antiplatelet agents it was 3 of 3 (100 per cent).

* For statins it was 2 out of 2 (100 per cent).

* For angiotensin-converting enzyme inhibitors it was 1 out of 1 (100 per cent).

* And for alpha-blockers, 1 out 1 randomized controlled trial (100 per cent) found generics to be clinically equivalent to brand names.

* In drugs that have a narrow therapeutic index (where you have to be really careful to give the right dose so as not to injure the patient), clinical equivalence was found in 1 out of 1 randomized controlled trial (100 per cent) for class 1 antiarrhythmic agents, and in 5 out of 5 (100 per cent) for warfarin.

* Pooling the results of all the trials gave a total of 837 participants and an aggregate effect size of -0.03 (95 per cent confidence interval of -0.15 to 0.08), meaning that across the studies as a whole, there was no statistically significant evidence that brand names were superior to generic drugs.

Reviewing the material from 43 editorials, the researchers found that:

* 23 of them (53 per cent), expressed a negative view about whether generic drugs could replace or be used instead of brand names.

* This compared with 12 (28 per cent) that encouraged substitution.

* The other 8 editorials did not reach a conclusion on interchangeability.

* Among editorials covering narrow therapeutic index drugs, 12 (67 per cent) expressed a negative view compared with 4 (22 per cent) in favour generic substitution.

Kesselheim and colleagues concluded that:

“Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.”

They wrote that the rising cost of prescription drugs is a critical policy issue: it strains the budgets of patients and insurance providers, and leads to poorer health as it works against helping everyone to make sure patients can complete their medication schedules.

“The primary drivers of elevated drug costs are brand-name drugs, which are sold at high prices during a period of patent protection and market exclusivity after approval by the Food and Drug Administration (FDA),” they added.

The idea of generics is to help people afford drugs, and these become available after the brand names have had their period of being the only ones on the market, the so called exclusivity period. Many doctors and payers encourage this.

However, some patients and doctors have been concerned that the generic versions may not be as effective. As Kesselheim and colleagues explained:

“Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts. Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs.”

Kesselheim and colleagues suggested that one explanation for the discordance between the clinical evidence and the opinion expressed by experts in the editorials could be that:

“Commentaries may be more likely to highlight physicians’ concerns based on anecdotal experience or other nonclinical trial settings.”

Another explanation they suggested was that the:

“Conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed.”

Nearly half the trials (23 out of 47) and nearly all the editorials and commentaries they reviewed did not reveal where the funding came from, noted Kesselheim and colleagues, who also wrote that:

“We identified numerous studies that evaluated differences in clinical outcomes with generic and brand-name medications. Our results suggest that it is reasonable for physicians and patients to rely on FDA bioequivalence rating as a proxy for clinical equivalence among a number of important cardiovascular drugs, even in higher-risk contexts such as the NTI drug warfarin.”

“These findings also support the use of formulary designs aimed at stimulating appropriate generic drug use. To limit unfounded distrust of generic medications, popular media and scientific journals could choose to be more selective about publishing perspective pieces based on anecdotal evidence of diminished clinical efficacy or greater risk of adverse effects with generic medications. Such publications may enhance barriers to appropriate generic drug use that increase unnecessary spending without improving clinical outcomes,” they added.

“Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease: A Systematic Review and Meta- analysis.”
Aaron S. Kesselheim; Alexander S. Misono; Joy L. Lee; Margaret R. Stedman; M. Alan Brookhart; Niteesh K. Choudhry; William H. Shrank.
JAMA. Vol 300, No 21, pp 2514-2526, December 3, 2008

Noroviruses are a group of viruses that are the most common cause of acute gastroenteritis and the HPA estimates that they affect between 600,000 and a million people in the UK each year. Infection can spread rapidly, and as Norovirus outbreaks continue to hit the headlines, the RIPH is pleased to announce it is running the first in a UK-wide programme of one-day courses on Norovirus in May.

The course is designed to provide delegates working in the hospitality industry with the skills needed to recognise the signs of Norovirus infection, and to prevent and manage outbreaks. By the end of the course, delegates will go away equipped with the skills necessary to prepare their own practical infection control strategy. The course will be particularly relevant to occupational health professionals, health and safety practitioners and environmental health officers.

Professor Rodney Cartwright, RIPH Trustee and Medical Adviser to the Federation of Tour Operators comments, “With the continuing difficulties involved in controlling Norovirus outbreaks, the RIPH is pleased to be continuing its educational programme on Norovirus, and this course will complement the three successful conferences we have already run on the issues surrounding this problem. The course will be of specific interest to those responsible for the management of infection in non-clinical outbreak settings such as hotels, cruise ships, health clubs and holiday sites.”

The course will cover:

- the clinical features of Norovirus, molecular identification and detection techniques;
- the importance of staff training;
- routine cleaning and product selection;
- procedures for declaring an outbreak;
- managing staff illness;
- reducing person to person spread;
- statistics and theory of hand hygiene (including practical demonstration and training);

Notes :

- The Royal Institute of Public Health was founded in 1886. Based in London, it is a leading independent body with an international reputation dedicated to the promotion, practice and protection of the highest standards of public health.

- It offers a wide range of public health related qualifications delivered through an extensive network of training centres nationwide.

- The Royal Institute enjoys the patronage of Her Majesty The Queen, an honour that has been conferred by the Sovereign continuously since 1897. The Royal Institute is a Registered Charity.

The Royal Institute of Public Health

A standard laboratory tool for measuring pharmacological activity of biological substances and performing other related tests may soon be replaced by a new miniaturized bioassay that will be faster, cheaper and more efficient for scientists to use, with new technology developed by Singapore’s Institute of Bioengineering and Nanotechnology (IBN).

The new assay, named DropArray, slashes the time needed to run certain lab tests by over 60 per cent and reduces consumable costs by nearly 90 per cent, while maintaining the same level of flexibility and convenience as conventional platforms.

According to IBN Team Leader Dr Namyong Kim, “Our technology has the potential to accelerate life science, drug discovery and clinical research. Using our technology, companies can benefit from huge savings in time and money spent on research and development and this would have a direct impact on the cost of medication and new drugs for the consumer.”

IBN’s DropArray represents a unique integration of surface chemistry and microfluidics designed to reduce the amount of material and reagent required by up to 1,000 times, while simultaneously cutting the reaction time by up to 10 folds, making it faster and cheaper than standard bioassays.

Each DropArray chip comprises a small (1 inch by 3 inch) flat rectangular patterned glass slide, with hundreds or thousands of hydrophilic glass “wells” surrounded by a hydrophobic coating. These chips can be used for common laboratory processes such as the heterogeneous bioassay, which is typically used by scientists in diagnostic tests to determine how a blood sample interacts with various other substances. The “wells” act as small test tubes in which the reagents are added, mixed and incubated, and a bench-top station automatically completes the rinsing process in heterogeneous bioassay.

IBN’s DropArray is able to miniaturize bioassays from 50-100 microliters down to 100 nanoliters, making it possible for researchers to conduct various cell-based tests including cancer stem cell immunoassays that had previously been extremely challenging with conventional technology.

Furthermore, the reduction in the volume of samples and reagents required provides similar advantages for protein-based assays such as ELISA with limited human and animal serum such as Human Leptin and Endostatin assays.

“This DropArray was realized through the efforts of an interdisciplinary team of researchers, which is typical of the project-oriented research at IBN,” said Prof Jackie Y. Ying, Executive Director of IBN, one of the 14 research institutes of Singapore’s Agency for Science, Technology and Research (A*STAR). Prof. Ying was one of the youngest professors at the Massachusetts Institute of Technology, and has received many awards for her research in nanotechnology. She was elected to the German Academy of Natural Scientists, Leopoldina, in April 2005 as the youngest member of the Academy.

“IBN was established less than 5 years ago with the mission to conduct exciting scientific research with significant commercial impact. Since then, we have filed more than 420 patents, and we are delighted that our entrepreneurial research team of one chemist, one biologist, one biomedical engineer, one mechanical engineer and one chemical engineer has taken less than three years to develop a novel technology platform that would contribute significantly to reducing the cost of drug development and medication. Curiox Biosystems, the company we set up to market this technology, is IBN’s first spin-off.”

Nanostart AG, the German-based world’s leading nanotechnology investment company, has invested in Curiox Biosystems, which will further develop and commercialize the DropArray technology. Curiox will be headed by 2 IBN researchers, Dr. Kim Nam Yong, a Korean and Singapore permanent resident who received his Ph.D. in Chemistry from the Massachusetts Institute of Technology, and Dr. Leck Kwong Joo, a Singaporean who received his Ph.D. in Medical Sciences from the Australian National University.

For Nanostart AG, the investment in Curiox marks its first in Asia, and is of strategic importance. Nanostart is investing in Curiox as the lead investor and is thus assuming an active role with its investment managers in the ongoing development of the company, jointly with Exploit Technologies, the commercialization arm of A*STAR.

“Our new investment holding, Curiox, is our first step into the highly promising Asian market,” explained Marco Beckmann, CEO of Nanostart AG. “Singapore has established an outstanding position for itself in Asia in nanotechnology. Through our investment in Curiox, we aim to directly participate in the dynamic growth of this region and to live up to our claim of global leadership. Further investments in Asia will follow.”

“We are delighted to learn that Nanostart is planning further activities including a local office in Singapore. It would bring along a significant international network of business contacts, and help other local enterprises in creating high value added jobs based on home-grown, cutting-edge technologies,” said Prof. Ying. She will hold a seat on the company’s board of directors along with a representative from Nanostart AG.

The U.S. represents Curiox’s largest potential market with more than 12,000 suitable academic and government labs, which spent $14.3 billion on lab instruments, consumables and reagents in 2005, and more than 14,000 industrial pharma and biotech labs, which spent $37.4 billion in 2005.

About the Institute of Bioengineering and Nanotechnology (IBN)

The Institute of Bioengineering and Nanotechnology (IBN) is a member of the Agency for Science, Technology and Research (A*STAR). Established in March 2003, IBN is headed by its Executive Director, Professor Jackie Y. Ying. The Institute’s mission is to establish a broad knowledge base and conduct innovative research at the interface of bioengineering and nanotechnology. Positioned at the frontiers of engineering, IBN is focused on creating knowledge and cultivating talent to develop technology platforms in the following six areas:

– Delivery of Drugs, Proteins and Genes
– Cell and Tissue Engineering
– Artificial Organs and Implants
– Pharmaceuticals Synthesis and Nanobiotechnology
– Medical and Biological Devices
– Bioimaging and Biosensing

Institute of Bioengineering and Nanotechnology

The Generic Pharmaceutical Association (GPhA) will host its 2008 Annual Meeting, “Generics: the Right Choice for Better Health,” on February 11-13, 2008, in Boca Raton, Florida. Featuring presentations from government, industry and Wall Street leaders, the meeting will examine the current healthcare environment and generics’ critical role in promoting affordable healthcare in the United States.

“As Americans consider their choices for President, Congress and state offices, there is no doubt that health care issues will be top of mind,” said GPhA President and CEO Kathleen Jaeger. “Today, as more Americans delay seeking health care and struggle with paying their bills, they are looking to their elected officials for answers. Increasing access to safe, affordable generics is simply the right choice for obtaining better health care at lower costs, and it is a fitting theme for this year’s meeting.”

Each year, the Annual Meeting brings together CEOs and other top officials from the generic pharmaceutical industry, including manufacturers, distributors, wholesalers, chain drug stores, and health care providers. During the 2008 meeting, participants will hear about the latest industry, legislative and regulatory trends and developments.

The 2008 Annual Meeting will be held at the Boca Raton Resort & Club in Boca Raton, Florida. The meeting kicks off on Monday, February 11 with an evening welcome reception. The plenary sessions and Business Exposition, featuring a diverse array of exhibitors, will be held on February 12-13, beginning with breakfast at 7:30 a.m. The complete agenda will be available in coming weeks.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.

The Generic Pharmaceutical Association

http://www.gphaonline.org

The Biotechnology Industry Organization (BIO) applauded President Bush and Congress for enacting the Energy Independence and Security Act of 2007, containing the new renewable fuel standard (RFS) that explicitly supports production of 36 billion gallons of biofuels, including cellulosic ethanol and advanced biofuels.

Brent Erickson, executive vice president for BIO’s Industrial and Environmental Section, issued the following statement:

“The Energy Independence and Security Act is a-game-changing moment in American history. This new law includes the most ambitious policy undertaken by any government in the world to create a viable, large-scale biofuels industry. We are about to move from ethanol being a bit player to being a major player in the transportation fuels industry. President Bush is to be commended for having the vision and leading the charge to develop next generation biofuels. It is also a rare and commendable example of Congressional bipartisan cooperation to accomplish a very significant change in public policy. This moment in the history of transportation fuels development can be compared to the transition from whale oil to kerosene to light American homes in the 1850′s.

“This effort to produce biofuels on a massive scale is an undertaking larger than the Apollo project or the Manhattan project. America can meet this goal because of the accelerating advances in industrial biotechnology. The new RFS will catapult the U.S. biofuels industry to the next level of commercial development and take us beyond conventional ethanol. It will accelerate the creation of a U.S. biobased economy built on sustainable and renewable resources instead of petroleum and it will reduce both our dependence on foreign oil and our climate change emissions.

“The RFS could add as much as $170 billion to the U.S. economy in advanced technology development, biofuel production, and infrastructure construction. McKinsey & Company analysts project that the new RFS will bring the potential for tens of billions of dollars for biotech companies, farmers, suppliers and fuel producers and necessitate the investment of more than 100 billion dollars for building some 300 new plants. The bold new RFS provisions in the federal energy bill will induce an unprecedented level of venture capital investment in the biofuel industry.

“In order to meet the new RFS we must couple advances in biotechnology with the building of this new renewable energy infrastructure across rural America. The industrial biotechnology and biofuel industries are ready and able to meet the challenge of sustainably increasing production of cellulosic and advanced biofuels to accomplish the goals of the new renewable fuels standard. Industrial biotechnology companies are already improving the technology for making conventional ethanol and cellulosic ethanol. And, we are developing new processes using microbes for making advanced biofuels – alcohols like biobutanol, and even hydrocarbons that can directly substitute for gasoline in fuel tanks.”

Renewable Fuel Standard Facts

- At the mandated volumes, biofuels would make up for more than 20 percent of total gasoline for road transport in the United States by 2022.

- These volumes imply a total revenue pool of about $50 billion to $70 billion for producers and very significant revenues for farmers and suppliers.

- Enzymes and fermentation organisms necessary for biofuels could represent a business opportunity worth $3 billion to $5 billion.

- Construction of this capacity requires major capital investments, up to $100 billion for building some 300 new plants.

- BIOWA ( a non-profit group in Iowa) estimates that 10 new cellulosic biorefineries would create 22,000 jobs, yielding $11.6 Billion Economic Impact/yr and $367M Iowa Tax creation.

- Reducing dependence on oil by about 1.5 million barrels per day is a major move for enhancing energy security.

- And the United States could reduce greenhouse gas emissions, mostly via use of lingocellulosic ethanol, by about 200 million tons of CO2 equivalents. For comparison, 200 million tons is more than the total emissions of countries like the Netherlands.

Upcoming BIO Events

BIO-Asia Partnering Conference
January 28-29, 2008
Tokyo, Japan

BIO CEO & Investor Conference
February 11-13, 2008
New York, NY

Partnering for Global Health
March 10-12, 2008
Washington, DC

BIO-Europe Spring
April 7-9, 2008
Madrid, Spain

World Congress on Industrial Biotechnology & Bioprocessing
April 27-30, 2008
Chicago, IL

BIO International Convention
June 17-20
San Diego, CA

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world’s largest gathering of the biotechnology industry.

http://www.bio.org

Drug companies are working on 691 new medicines that treat diseases disproportionately affecting blacks, according to a report issued by the Pharmaceutical Research and Manufacturers of America, the Memphis Business Journal reports.

According to the report,

* 229 of the drugs are for cancers that disproportionately affect blacks;

* 114 address cardiovascular disease;

* 95 are to treat diabetes;

* 77 are for respiratory conditions, including asthma;

* 67 target HIV; and

* Other treatments will address kidney disease, glaucoma, obesity and sickle cell disease.

PhRMA President and CEO Billy Tauzin said in a statement, “There are complex reasons for the health disparity between African-Americans and other Americans that are not fully understood. These 691 medicines in development offer hope for closing the troubling health gap and increase the likelihood that every American can share in the benefits of medical progress” (Memphis Business Journal, 12/10).

The report was delivered to Mississippi Gov. Haley Barbour (R). Mississippi has the largest population of blacks in the U.S., according to the U.S. Census Bureau.

PhRMA Senior Vice President Ken Johnson said, “The diseases highlighted in the report … are among the diseases that disproportionately affect African-Americans in Mississippi” (PhRMA release, 12/10).

The report is available online (.pdf).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

The three representatives of the European Parliament in the EU High Level Pharmaceutical Forum, Francoise Grossetete, Dagmar Roth-Behrendt and Jorgo Chatzimarkakis, hosted a conference entitled The informed patient – What the European Union has to do at the European Parliament in Brussels.

A wide range of European stakeholders discussed concrete ways to reduce the current inequalities among different population groups and EU Member States in accessing high-quality information throughout the “patient journey” (prevention, early diagnosis, treatment and compliance).

At the conference, AESGP Director General Hubertus Cranz called for an adequate interpretation of the current legislative provisions with regard to the labelling of medicinal products. This should allow the addition of non-promotional information on the package so that companies would for instance be allowed to mention a website address which may provide valuable additional information in relation to a particular condition. Smoking cessation was a concrete example where this would be useful, said Cranz.

Cranz also drew particular attention to the important role of health professionals in providing information on non-prescription medicines and the need to improve curricula and training programmes for medical doctors and pharmacists so that their support potential for European citizens is fully developed.

The European Commission is expected to adopt its report on current practices with regard to the provision of information to patients on medicinal products before the end of 2007 and to put forward a proposal for legislative change in this area in the fourth quarter of 2008.

Background:

The Association of the European Self-Medication Industry (AESGP) represents the manufacturers of non-prescription medicinal products in Europe.

Association of the European Self-Medication Industry

“Over the next few years, the pharmaceutical industry will hit a wall,” the Wall Street Journal reports in an examination of challenges that face large pharmaceutical companies. In future years, some of the “top-selling drugs in industry history will become history as patent protections expire,” with generic competition “expected to wipe $67 billion from top companies’ annual U.S. sales between 2007 and 2012″ — an amount equal to “roughly half of the companies’ combined 2007 U.S. sales,” according to the Journal.

Meanwhile, the “industry’s science engine has stalled,” as the “century-old approach of finding chemicals to treat diseases is producing fewer and fewer drugs,” the Journal reports. Datamonitor estimates that annual revenue for the pharmaceutical industry between 2011 and 2012 will decrease for the first time in at least four decades.

In response to those issues, pharmaceutical companies have begun to reorganize. “In five years, many may look very different,” the Journal reports. According to the Journal, many pharmaceutical companies will “be in new businesses,” their “cost structures may be slimmer and more flexible” and some “familiar names may disappear in mergers.” A number of pharmaceutical companies also have entered research initiatives or partnerships to develop biotechnology medications and have expanded their generic medication businesses. Some pharmaceutical companies also have indicated they will seek to outsource manufacturing capabilities to help reduce costs.

In addition, the “dearth of new products has led the industry to invest heavily in marketing and legal tactics that squeeze as much revenue as possible out of existing products,” the Journal reports.

Richard Evans, a pharmaceutical industry consultant and a former Wall Street analyst, said, “The era that created the modern pharmaceutical industry is over.” Sidney Taurel, chair of Eli Lilly, said, “I think the industry is doomed if we don’t change” (Martinez/Goldstein, Wall Street Journal, 12/6).

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