Tuesday, April 30, 2013

Eli Lilly Aborted Trial

"Indianapolis-based Eli Lilly and Co.  argues in court documents that there is no evidence that the Melnick sisters’ mother even took DES. She and her doctor are dead, and the drug company says there are no medical records documenting her treatment. A company spokesman said Eli Lilly believes the claims are without merit."

Then why did you $ettle?

"Eli Lilly settles suit with sisters who say pregnancy drug their mother took gave them breast cancer" by Milton J. Valencia  |  Globe Staff, January 10, 2013

Days into a closely watched trial in federal court in Boston, the mammoth drug manufacturer Eli Lilly and Co. settled a landmark lawsuit Wednesday with four sisters who said their breast cancer was caused by medication their mother took during pregnancy in the 1950s....

The case involving the ­Melnick sisters, who grew up in Pennsylvania, was believed to be the first involving the drug’s alleged ties to breast cancer to go to trial nationally. Many similar cases involving vaginal and cervical cancer have been settled across the country....

See: Gross Post

In a statement, Eli Lilly said, “While we continue to ­believe that Lilly’s medication did not cause the conditions ­alleged in the lawsuit, we believe the settlement is in the best interest of the company. Settling this trial helps us get back to what we want to focus on as a company; developing important new medications through research and partnerships with doctors and patients.”

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“The science has caught up to the truth,” said Caitlin McCarthy, a DES educator and activist who is not involved in the lawsuit, but whose mother took the drug....

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Related: This Post is Tit

Slow Saturday Specials: The Morning After

"Contaminants in fertility drug called harmless" by Kay Lazar  |  Globe Staff, March 01, 2013

Particles found floating in ­vials of a fertility drug that was recalled last week by a Waltham speciality pharmacy have been identified as apparently harmless pieces of the vial’s rubber stopper.

Laboratory results given to the Globe late Thursday by ­Village Fertility Pharmacy, which commissioned the ­report, concluded: “The ­vials contained numerous particles that contain polyisobutene with substantial amounts of talc and silica. This composition is typical of rubber stopper formulations.”

The analysis, conducted by McCrone Associates, an Illinois laboratory, was marked preliminary, with a notation that complete findings will be forwarded later. It also noted that the analysis was performed on a “rush basis.”

The pharmacy announced Sunday that it had recalled several compounded medications shipped over the past three months, after the contamination discovery. No patients who received the drugs have reported any adverse effects.

Company spokesman David Ball said Thursday that pharmacy officials are relieved that the contamination appears to be benign.

“They are obviously really pleased, because it’s the best outcome of any of the scenarios,” Ball said.

“It’s not uncommon for rubber to end up in the vial during production,” Ball said. “The rubber gets pushed into the chamber of the vial, but it usually doesn’t get pulled back up in the syringe” during use.

State health officials were not available late Thursday for comment about the latest findings.

Officials issued a cease-and-desist order Feb. 20, prohibiting the company from making sterile compounded drugs, pending a state and federal inves­tigation. Compounded drugs are specially prepared in formulations and doses unavail­able off the shelf, and sterile medications are injected or used intravenously.

Scrutiny of compounding pharmacies has increased after a fungal meningitis outbreak was linked last fall to New ­England Compounding Center in Framingham. Contaminated injectable steroids made by the company sickened 714 people, including 48 who died, in 20 states, according to the US ­Centers for Disease Control and Prevention.

After the meningitis outbreak, state health officials started surprise inspections of compounding companies.

They issued a statement Sunday saying that Village Pharmacy was last inspected in November by state investigators, who found “minor deficiencies that were addressed through a corrective plan.”

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RelatedSlow Saturday Special: FDA Finds More Problems at Compounding Pharmacies 

Meanwhile, the state is all bunged up about medical marijuana regulations.