The FDA has approved Gilenya for use in slowing the progression of multiple sclerosis and reducing the frequency of disease relapses. The drug, developed by Novartis, becomes the first federally approved oral treatment for the debilitating disease, which affects 400,000 people in the US and more than 2 million people around the world.

Novartis had been in a race with Merck to be first-to-market with an effective oral treatment for multiple sclerosis, a disease that attacks the central nervous system and causes symptoms ranging from double vision to gait abnormalities and even stroke-like symptoms.

Marck’s anti-MS drug, cladribine, will be reviewed and possibly approved by the FDA before the end of this year.

Industry analysts and Novartis expect Gilenya to achieve at least $1 billion in annual sales.

Until the FDA green-lighted Gilenya, the only FDA-approved options for MS patients were intravenous drugs produced by Biogen Idec and Bayer. Biogen’s products, Avonex and Tysabri are leaders in MS market, which is estimated to be worth $8.6 billion per year.

“A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease,” Nicholas LaRocca, a VP at the National Multiple Sclerosis Society told BurrillReport.

In approving Gilenya, the FDA warned that patients who take the drug should be observed for slow heart rates shortly after therapy begins, and that the drug may be associated with infections.

For its part, Biogen Idec added in a statement that the long-term safety of Gilenya “has yet to be established.”

The mechanism of action of Gilenya remains unknown.  Many scientists believe it modulates a pathologic tendency for the body’s white blood cells to attack myelin, a fat-like substance that forms a protective sheath around nerve cells.

An FDA advisory panel has recommended that the agency approve a Massachusetts-based company’s plans to commercialize its genetically-engineered salmon, which grow to adult size nearly twice as fast as their natural-born counterparts.

If the FDA follows the recommendations of the Veterinary Medicine Advisory Committee, the modified salmon will be the first such animal to be marketed in the US.

The Committee is comprised largely of veterinary scientists. It concluded that the new salmon was safe to eat and that the process used to grow it would not pose a significant threat to the environment.

The FDA is not required to follow the recommendations of its advisory panels. It will probably take months before deciding the matter.

Waltham-based AquaBounty has been working on its AquAdvantage Atlantic salmon for over a decade. They grow quickly because company scientists inserted genes encoding for growth hormone from both the Chinook salmon and an eel-like creature known as the ocean pout into their DNA.

The modified fish produce growth hormone year-round. Native Atlantic salmon don’t produce the stuff, and hence don’t grow, each winter. The AquAdvantage salmon end-up being sterile females, for the most part.

AquaBounty plans to grow its genetically-modified salmon in inland tanks to prevent them from interacting with native species. “The possibility of an escape or an event with any possibility to interact with the wild population is infinitesimal,” Ronald Stotish, AquaBounty’s CEO told BurrillReport.

By the way, the Advisory Committee suggested that the FDA monitor the environmental impact of AquaBounty’s commercial operations if they are approved, and that consumers be appraised about what they are buying. Current FDA rules ban labeling that is based exclusively on how foods are produced.

Unsealed documents from a dispute involving Wyeth Pharmaceuticals show the drug company paid ghostwriters to prepare articles that emphasized positive findings about post-menopausal hormone replacement therapy as part of a strategy to stem growing public concern about the treatment.

The articles include several dozen clinical trial reports and literature reviews. They were reviewed by Adriane Fugh-Berman, an associate professor in the Physiology Department at Georgetown.

Fugh-Berman published her review in PLoS Medicine. She presented her findings while serving as a paid expert witness in a court case brought by 14,000 plaintiffs. These people allege that their breast cancer might have been caused by a Wyeth-made hormone replacement drug known as Prempro.

In her testimony, Fugh-Berman said the ghostwriting strategy included promoting off-label, unproven uses of Prempro such as the prevention of dementia, vision problems, wrinkles and Parkinson’s disease. The strategy also featured a hearty defense of supposed cardiovascular “benefits” of hormone replacement therapy and an attempt to cast doubt about several competing therapies.

The ghostwritten articles were circulated to drug representatives and eventually to physicians.

The ghostwriting outfit at the center of the matter is DesignWrite, medical education and communication company. Wyeth or its representatives apparently paid DesignWrite $25,000 per ghostwritten report of a clinical trial. DesignWrite also wrote 20 review articles, receiving $20,000 a pop.

“The medical profession must ensure that prescribers renounce participation in ghostwriting, and ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” the PLoS study says.

In a statement to Reuters, Pfizer (which now owns Wyeth) tried to dismiss the report. “Even with her critical perspective, (Fugh-Berman) could not establish that there were inaccuracies in any of the peer-reviewed articles, or that their authors relinquished control over their work,” the statement said.

With things in Washington as politically charged as they are nowadays, it’s unlikely that any kind of tax legislation will be passed before the mid-term elections. That’s unfortunate, since many key parts of our tax code are governed by laws that will expire at the end of this year. The combination of expiring tax laws and legislative gridlock makes it tough for people and businesses to plan for things like, oh say, their future.

As an example, take President Obama’s suggestion that Congress should permanently extend the Research and Experimentation Tax Credit.

The Big O wants the credit increased by 20% for eligible US-based projects, a move that would save companies over $100 billion during the next decade. If passed, the bump would be by far the largest increase since the credit was introduced in 1981.

The Research and Experimentation Tax Credit had been extended 13 times since 1981. Last year however, Congress allowed the credit to lapse amid unprecedented partisan bickering.

“Making this provision permanent would give businesses the certainty they need to accelerate R&E investments to create jobs today and in the future,” said the White House in a press release.

Trade groups representing the pharmaceutical and life sciences industries support the R&E tax credit, but venture capitalists that fund life sciences companies are far less sanguine. In part, this is because the companies they back, who need R&E funding the most, don’t see any near-term benefits from the credit, since they typically don’t have tax liabilities to offset.

But it’s actually much worse than that for venture investors. See, the administration’s proposal pays for the credit by changing the way “carried interest” is taxed. For 30 years, carried interest has been taxed at the long term capital gains tax rate. The new proposal calls for it to be treated as ordinary income, a huge negative for venture investors. The Big O’s proposal is in effect extracting a pound of flesh from VCs in order to create a credit for companies that are attempting to kill the companies they back.

“This policy would essentially double the taxes for venture capitalists — our country’s job creators, discouraging investment in new companies at a time when Congress should be doing all it can to support the start-up ecosystem,” said the National Venture Capital Association.

Plexxikon announced last week that its experimental drug shrank melanoma tumors in a whopping 81% of the patients who received it.

Scientists suggested that the positive results from this early-stage trial might represent a breakthrough in the treatment of a notoriously recalcitrant malignancy, even though the drug’s beneficial results were not permanent. The cancers began growing again in every patient but two after the course of treatment ended.

“Metastatic melanoma is a challenging disease to treat. There have been no significant therapeutic advances in the past 20 years,” Paul Chapman, senior author of the study told BurrillReport.

“We learned that half of melanomas are addicted to a mutated gene called BRAF; this new drug inhibits BRAF and shuts off these tumors,” added Chapman, who is an attending physician at the Melanoma and Sarcoma Service at Memorial Sloan-Kettering.

The BRAF mutation occurs in 40-60% of people with melanoma.

Berkeley-based Plexxikon’s experimental drug is called PLX4032. It appeared to shrink metastatic lesions in multiple locations including liver, bone and the small bowel.

Plexxikon has co-developed the drug with Roche under a license and collaboration agreement. Roche also plans to market a gene-based diagnostic tool that can identify melanoma patients who carry the genetic peculiarity that renders their cancers receptive to PLX4032.

Plexxikon has begun mid- and late-stage studies of its drug simultaneously in an effort to find out as quickly as possible whether it can improve survival in patients with melanoma.

Recently, the CDC reported that between 2007 and 2009, the number of states with at least a 30% prevalence of obesity tripled from three to nine. As recently as 2000, no state reported having as many as 30% of its population that were obese.

Overall, 72 million American adults, representing 26.7% of the adult population, are obese. That’s up 1% since 2007, according to the CDC, which also calculated the annual medical costs of obesity to be nearly $147 billion.

The CDC report is based on data from the Behavioral Risk Factor Surveillance System, which contains self-reported data that is used by the states to assess progress toward the goals of Healthy People 2010. In the BRFSS 400,000 phone survey respondents are queried each year about their height and weight. From these data, scientists calculate body mass index. An adult with a BMI > 30 is considered to be obese.

BRFSS data are known to underestimate obesity prevalence, since respondents tend to claim they are taller than they actually are, and since women tend to claim they weigh less than they really do.

“We need intensive, comprehensive and ongoing efforts to address obesity,” CDC director Thomas Frieden told BurrillReport. “If we don’t, more people will get sick and die from obesity-related conditions such as heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of death.”

The new data reveals that the highest prevalence of obesity, 36.8%, is present among non-Hispanic blacks. In non-Hispanic black women, the rate is 41.9%. The data also show that obesity is more prevalent in the South and Midwest than in other regions of the country.

Colorado is the only state that had a prevalence of obesity less than 20%.

Recent, widespread dissemination of smartphones and improvements in wireless network coverage have created an opportunity for people to take a more active role in maintaining their health. It also permits physicians to remotely monitor patients and detect evolving health issues quickly and cheaply.

One potential impediment to such progress would be an overbearing regulatory environment which could slow innovation and discourage investment at a critical juncture in the evolution of the technologies.

To their credit, the Food and Drug Administration and the Federal Communications Commission have recognized this risk. Recently, the 2 agencies held a joint summit in which they tried to address the matter. During the summit, they agreed to cooperate on matters that cross their traditional domains, while focusing on ways to assure the safety and reliability of wireless medical devices and increase their availability to providers and consumers of health care.

“The American public–including industry, providers, patients, and other interested stakeholders–should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market,” the agencies said in a joint statement. “This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.”

The summit was attended by leaders from healthcare, technology, academia, and the venture capital sector. 

“The relationship between FDA approval and FCC certification of wireless-enabled medical devices must be further delineated and expedited to overcome hurdles to innovation identified by both agencies,” Joseph Smith, the chief science officer for the West Wireless Health Institute said at the conference.

Venture capitalists welcomed the initiative.  “As an area of investment, this arena is challenging, due to the regulatory uncertainty,” said Jim Glasheen, a general partner at Technology Partners. “I am enthusiastically supportive that the FCC is working together with the FDA in taking a first-step towards a pro-investment/pro-innovation policy.”

So-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.

These deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.

In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements.  That’s more than the entire previous year.

“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”

The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.

Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”

The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.

A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.

Paying people to avoid sexually transmitted diseases effectively reduces their spread, according to a proof-of-concept study carried out by scientists at UC Berkeley, the Development Research Group at the World Bank and the Ifakara Health Institute in Tanzania.

The study involved young adults in southwestern Tanzania. Subjects were randomly assigned to a high-payment group, a low-payment group and no-payment control group. Participants in the high payment group received $20 every 4 months–up to $60–if they tested negative for STDs. Those in the low-payment group received half that amount.

Participants in all groups received individual counseling and could attend monthly group counseling sessions as well. Any participant that tested positive for an STD received free care for the condition.

By the end of the year, 9% of participants in the high-payment group had tested positive for an STD. That was significantly better than the 12% rate seen in both the control group and the low-payment group. The cash reward had the same impact in men and women. It had a more pronounced effect in people with lower incomes.

“For many of our study participants, $60 represented about one-fourth of their reported annual income, so it was a significant incentive,” says Will Dow, a study author and a health economist at Berkeley. “The question we tested is whether the cash reward was enough of an incentive to reduce risky behavior. The fact that disease prevalence decreased suggests the incentives worked.”

Participants were tested for chlamydia, gonorrhea and syphilis. HIV/AIDS status was not tested, but the same sexual behaviors that increase the risk of the STDs increase the risk of HIV.

Continuing a trend that began more than 2 decades ago, the death rate from cancer in the US dropped 1.3% year-over-year in 2010. It now stands at about 178 people per 100,000 per year.

The news is contained in a report prepared by epidemiologists at the American Cancer Society and published in CA: A Cancer Journal for Clinicians. The scientists estimate there will be about 1,530,000 new cancer cases in the US in 2010 (790,000 in men and 40,000 in women), and 569,000 deaths due to cancer (299,000 in men and 270,000 in women) in the US in 2010.

According to the report, cancer death rates have dropped 21% in men, and 12% in women since 1991. The report attributes the fall-off to fewer people smoking, improved treatment, and better screening.

In men, cancers of the prostate, lung, and colon will be the cause of 52% of all newly diagnosed cancers this year. Prostate cancer alone will cause 28% of these, and 90% of these cases will be discovered at local or regional stages, for which the five-year survival rate is nearly 100%.

In males who are less than 40 years of age, leukemia is the most common fatal cancer. In older men, lung cancer becomes the leading killer.
 
For women, cancers of the lung, breast and colon account for 52% of newly diagnosed cancer cases. Breast cancer alone will cause of 28% of all new cancers in women this year.

Leukemia is the leading cause of cancer death among women less than 20 years old. Breast cancer ranks first for those between the ages of 20 and 59. After that, lung cancer becomes the leading cause of cancer death.

Lung cancer surpassed breast cancer as the leading cause of cancer death in women in 1987. It will be responsible for 26% of all cancer deaths in women this year.