Tag Archives: biotech

Biotech firm to pay $3.5M fine to settle animal-abuse case

A leading biotech firm will pay a $3.5 million fine and cancel its research registration to settle allegations that it mistreated goats and rabbits at a California facility.

The settlement between Santa Cruz Biotechnology Inc. and the U.S. Department of Agriculture also revokes the company’s license to sell, buy, trade or import animals.

The settlement required the Dallas-based company to pay the fine and cancel its research registration by May 31.

The USDA’s complaints listed violations ranging from failing to provide veterinary care to goats with wounds from coyote and snake bites or massive tumors and housing rabbits in cruel conditions, including putting them in elevated cages with open doors or in small, crowded cages.

Santa Cruz Biotechnology contested the government complaints and the agreement says the company “neither admits nor denies” the USDA’s assertions.

The company did not respond to requests for comment.

The Animal Welfare Institute, an advocacy group, praised the settlement, saying the $3.5 million fine is historic.

“Previously, the highest penalties paid to the USDA were less than $300,000, demonstrating the monumental nature of this settlement,” said Cathy Liss, president of the institute. “It should serve as a loud and clear message to all research facilities, animal dealers, exhibitors and airlines regulated under this law.”

Clinton vows to address ‘price gouging’ in drug industry

Democratic presidential frontrunner Hillary Clinton said she’ll soon release a plan to address “price gouging” in the industry.

Clinton’s announcement on Twitter followed news that drugmaker Turing Pharmaceuticals hiked the price of a 53-year-old drug for a potentially deadly parasitic infection from $13.50 per pill to $750. Because the drug, Daraprim, treats patients with compromised immune systems, the price hike of more than 5,000 percent sparked outrage from medical groups representing doctors who care for patients with HIV and other infectious diseases.

Biologic drugs are produced in living cells and specialty drugs treat complex, chronic conditions, usually need to be injected and sometimes refrigerated, and also are very expensive.

Many new drugs for cancer, hepatitis C, rare disorders and even a new class of cholesterol drugs have prices in the range of $80,000 or more for a year or course of treatment. Some are major medical advances, saving lives and other medical costs. Others are minor improvements, such as cancer drugs that add a few months’ survival over existing medicines.

The Turing price hike is only the latest – though perhaps most outrageous – example of price hikes, or sky-high prices for newly launched drugs.

Insurance companies, politicians, advocates for patients and other critics have been blasting those prices as outrageous and unsustainable for the health care system, not to mention patients who sometimes must pay up to 30 percent of the cost.

In the case of Turing’s Daraprim, the company obtained rights to sell the drug, the only U.S.-approved treatment for toxoplasmosis, in August and hiked the price overnight.

The company, run by a former hedge fund manager named Martin Shkreli, on Sept. 21 repeated comments meant to justify the increase, saying that Turing hopes to improve the drug’s formulation and develop new, better drugs for the infection. It also stressed that some patients can get financial aid from the company to obtain the drug.

Chad Griffin, the president of the Human Rights Campaign, wrote to Turing on Sept. 21: “Your greed in raising the single-pill price from less than $15 to more than $750 is unconscionable. It immediately puts at risk scores of medically vulnerable people, including those living with HIV, and women who are pregnant. Medical organizations have estimated that this predatory move could increase the average cost per year for an adult patient reliant on the drug to more than $630,000.”

He continued, “Your action is an appallingly egregious example of deep, damaging problems in our nation’s drug pricing system–a problem we will continue to urge our nation’s elected officials to tackle with vigor and care. Instead of taking advantage of our system to turn a profit, I call on you to restore fair pricing for Daraprim.” The HRC is the nation’s largest LGBT civil rights group.

Biotech analyst Steve Brozak, president of WBB Securities, said that because of the furor over Turing’s action, pharmaceutical and biotech drugmakers will have to defend themselves “against the coming onslaught.”

“I don’t think Turing has a defense,” Brozak said, adding, “As long as this is debated, nothing good for the biotech industry and biotech investors can happen.”

Clinton’s chief rival for the Democratic nomination, Vermont Sen. Bernie Sanders, has been railing about high drug prices for about a year and recently reintroduced legislation that would enable the Medicaid program to get lower prices for some drugs and allow U.S. residents to buy cheaper drugs from Canada.

Trade groups representing pharmaceutical and biotech companies oppose letting Americans buy drugs overseas and have repeatedly said in the past couple of years that price controls would limit the amount of money their companies can spend on research, limiting the number of new drugs developed.

While small companies trying to win their first approval might have trouble money raising capital from investors, many of the top makers of biologic and specialty drugs are flush with cash and spend more on marketing than research and development.

Oregon seeks to be 1st state to map GMO fields

Before residents in southern Oregon overwhelmingly voted to ban genetically modified crops earlier this summer, farmers negotiated for months with a biotech company that grows engineered sugar beets near their fields.

Their goal was to set up a system to peacefully coexist, an online mapping database of fields to help growers minimize cross-pollination between engineered and non-engineered crops.

But the effort between farmers and Swiss company Syngenta failed, leading to the ban.

Last October, Oregon Gov. John Kitzhaber directed the state’s Department of Agriculture to undertake something far more ambitious than that failed mapping effort – map GMO field locations across the entire state and establish buffer zones and exclusion areas for GE crops.

The move was spurred by several instances of genetic contamination in the region that rendered non-engineered crops unsellable on the export market.

If the mapping goes ahead, Oregon would be the first state to map fields and mandate preventive measures for modified crops. Advocates say Oregon could become a model for the rest of the nation.

The failed mapping effort in southern Oregon illustrates the challenges in reaching a consensus on GMO mapping amid mutual mistrust, a dearth of regulations and intense consumer attention.

A U.S. Department of Agriculture committee has recommended informal neighbor farmer agreements and an insurance system to pay for damages resulting from GMO contamination. But organic farmers are pushing for more disclosure, formal prevention measures and a system to hold GE growers liable for cross-pollination.

In Oregon, where over 200 crops are cultivated on nearly 24,000 farms, most crops do not have genetically modified counterparts, as only a handful of GE crops such as corn, alfalfa and sugar beets are permitted in the U.S.

Cross-pollination can occur when two crops within the same species flower simultaneously in nearby fields and pollen is carried from one to another via wind, insects, machines or human activity. Genetic engineering is prohibited in U.S. organic crops and many countries restrict imports of engineered products.

“There’s this need, a perceived need and real need in some markets, that they need zero contamination. And that is very difficult to achieve,” said Carol Mallory-Smith, professor of weed science at Oregon State University.

Already, dozens of seed associations across the nation – organizations for farmers who grow crops for seed – do mapping, also called pinning, and set isolation distances among crops to limit cross-pollination.

Some biotech companies participate in such mapping. But the efforts are voluntary and spotty, with locations and dates of planting available only to fellow growers, not officials or the general public.

Monsanto and other biotech outfits that hold patents to GE seeds resist publicly disclosing GMO field locations for competitive reasons. They claim farmers already coexist throughout the U.S. and more monitoring isn’t needed.

They are backed by farmers who plant GMO crops and worry that mapping could lead to crop sabotage and an outright ban on all GMO cultivation, regardless of the likelihood of contamination.

“More mapping would be redundant; we’re already doing it internally, we all work together with other farmers,” said Robert Purdy, who grows GE sugar beets for seed in the Willamette Valley. “If mapping were made public, nothing could stop people from pulling out those sugar beet plants.”

The company that contracts with Purdy for the seeds is a member of the Willamette Valley Specialty Seed Association, which maps more than 1,200 fields as part of a pinning system in northwestern Oregon – meaning Purdy can coordinate what to grow and where with his neighbors.

But organic farmers and other advocates say a mandatory mapping and monitoring system that covers all regions of the state and the nation is badly needed to retain crop and seed purity. It could increase transparency, help pinpoint the cause and location of contamination, and determine liability if economic harm is done.

“Mapping would bring transparency to a system that’s extremely opaque. It would allow for causation and traceability,” said George Kimbrell, a senior attorney at the Portland-based Center for Food Safety.

In southern Oregon, where the seed association recently formed to map fields, without Syngenta’s input, member farmers said the biotech giant walked out on them at the last minute.

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