Pharma news highlights: Gleevec, pay-to-delay, human gene patents and data analysis errors

Ed Silverman

Pharmalot

Ed Silverman’s news highlights this month include pay-to-delay, the Gleevec decision, human gene patenting and data analysis errors for Diovan.

(Continued from “Pharma news highlights: licensing, clinical trial data and safety issues”)

Gleevec ruling

Various legal matters have dominated headlines since our last appearance here. The most prominent, of course, involved a landmark ruling from the Indian Supreme Court, which rejected a patent sought by Novartis for its Gleevec cancer medication, a move that will allow lower-cost generic versions to continue to be sold. The decision ends a seven-year battle that both the drugmaker and patient advocates expect will have far-reaching consequences for the pharmaceutical industry when it comes to prices and access to a wide variety of medicines.

The case focused attention on the contentious interplay between intellectual property rights and the ability of the economically disadvantaged to afford needed drugs. Novartis sought a 20-year patent extension for Gleevec, but a previous government ruling denied its request after deciding a new form did not meet a standard for enhanced efficacy.

Patient advocates argued a Novartis victdory would have amounted to evergreening, a reference to patent extensions based on minor changes, and inhibit access to Gleevec since generic drugmakers would be prevented from making copycats. Gleevec can cost up to $70,000 a year, while generic versions made by Indian companies cost about $2,500 a year. As for Novartis, the drugmaker now argues the decision will cause pharma to avoid making R&amp,D investments in India.

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“…the drugmaker now argues the decision will cause pharma to avoid making R&amp,D investments in India.”

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Pay-to-delay deal

In the US, the Supreme Court there heard arguments about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date.

At stake is a decision that could influence the cost of medicines for most Americans, because the ruling is expected to determine the pace at which lower-cost generic drugs become available. Drugmakers have struck dozens of these deals over the past decade or so, prompting increasing scrutiny at a time of rising health care costs.

The issue has divided lower courts for years as the pharmaceutical industry and its allies have argued the agreements have actually speeded lower-cost generics to market. But opponents – which include the US Federal Trade Commission and many state attorneys general – argue the deals are harmful antitrust activity. The FTC has issued reports showing the deals force consumers to pay $3.5 billion a year in higher drug costs.

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“…research and innovation would be squelched if intellectual property rights and investments were not honored and rewarded.”

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Human gene patenting

The US Supreme Court also heard arguments in another case that captivated biopharma because it raises crucial questions about whether human genes can be patented. The outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

The court is reviewing a lower ruling that upheld the right of Myriad Genetics to patent two human genes that form the basis of a widely used genetic test for breast and ovarian cancers. A decision last year by a federal appeals court gave Myriad the right to patent two so-called isolated human genes – BRCA1 and BRCA2 – that account for most inherited forms of the cancer.

The case began three years ago, when the ACLU and the Public Patent Foundation sued Myraid (MYGN), the University of Utah Research Foundation and the US Patent &amp, Trademark office. They charged that Myriad’s refusal to license its patents broadly meant women who fear they may be at risk of having cancer are prevented from having anyone but Myriad look at the genes in question.

Many women with a familial history undergo genetic tests to determine if they have mutations on their BRCA genes. The info helps decide on treatment or prevention, such as increased surveillance, preventive mastectomies or ovary removal. Women who test positive using the Myriad BRACAnalysis test have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer. However, each test may cost about $4,000 and the patents prevent Myriad competitors from offering such a test without paying a fee.

Those who want the Myriad patients overturned say this amounts to a monopoly, while Myriad, other drugmakers and their supporters say research and innovation would be squelched if intellectual property rights and investments were not honored and rewarded.

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“The lead researcher maintained the errors were accidental and stood by the conclusions.”

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Diovan data analysis errors

A controversy over published research for the Diovan blood pressure drug sold by Novartis and researchers at a Japanese university grew stickier. Several papers have already been retracted amid heightened scrutiny over a relationship between the drugmaker and the Kyoto Prefectural University of Medicine.

Three papers submitted by university researchers found Diovan was more effective. One paper, in particular, claimed the drug also reduced the risk of heart attacks and strokes, which Novartis used in its promotions. The study was published in 2009 and helped Diovan become a huge seller in Japan.

But there were problems with all three papers. The Japanese Circulation Society last winter retracted two papers, citing “serious errors in data analysis.” One paper found Diovan helped diabetics avoid heart disease, and the other claimed the drug could benefit high-risk patients with high blood pressure.

The lead researcher maintained the errors were accidental and stood by the conclusions. At the time, he claimed “there must have been mistakes made when the data was totaled up, but this doesn’t affect the paper’s conclusions,” he was quoted saying in a Japanese newspaper.

But the European Heart Journal issued a retraction of a third paper that was published in 2009 and had made similar claims about reducing heart attack and stroke risks. The journal explained there were “critical problems with the data” and discouraged any citations.

But by then, Novartis was citing the studies in its promotions. Meanwhile, a Novartis Pharma employee was listed as a statistician on a fourth paper concerning Diovan, but was only listed as being affiliated to Osaka City University. And the drugmaker donated more than $1 million in research funding to the medical school.

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“…a group of thieves cut through the roof and hauled away enough medicines to make it the largest such pharmaceutical theft in US history.”

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Eli Lilly warehouse scandal

Finally, for those who sometimes wonder if the pharmaceutical industry lacks drama, consider the following. The security company that serviced an Eli Lilly warehouse that was the subject of a sensational break- in three years ago, may have inadvertently led to the $70 million heist of numerous drugs, according to a lawsuit.

The back story: In early 2010, ADT Services completed a proposal to upgrade systems at a Connecticut warehouse. And less than a month later, a group of thieves cut through the roof and hauled away enough medicines to make it the largest such pharmaceutical theft in US history. More than dozen people were later arrested, a lawsuit filed by Lilly’s insurer says the thieves had detailed technical knowledge of the system.

National Union Fire Insurance of Pittsburgh cited other instances in which one of the Lilly ringleaders had also been charged with burglarizing other warehouses belonging to other companies that were serviced by ADT. Consequently, the thieves allegedly knew such things as the only loading bay beyond the view of surveillance cameras, where to park a tractor trailer and where to cut a hole in the roof to land in the only safe entry point in the building. The insurer wants $42 million in damages.

The next ‘Pharma news highlights’ will be published in May 2013.

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About the author:

Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for the past 16 years. In addition to editing Pharmalot, he is currently an editor-at-large for Med Ad News.

Previously, he was a bureau chief for The Pink Sheet, the venerable industry newsletter, and a contributor to its sister publication, In Vivo magazine. Before that, Silverman worked as a business writer for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, where he conceived and launched Pharmalot. During his 13-year tenure, he closely followed a variety of topics of concern to those who work for, and with, drugmakers – drug development, mergers and acquisitions, regulatory oversight, safety and pricing controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor’s Business Daily, among other newspapers. He has a master’s degree in journalism from New York University and a bachelor’s degree in accounting from Binghamton University. Tethered to his laptop and Blackberry, Silverman lives in suburban New Jersey with his wife, three children, a sizeable Labrador retriever and a sneaky beagle.

Did the Indian Supreme Court make the right decision over Gleevec?