Billion-Dollar Cancer Drug Owners Dodge Suit

(CN) - The Swiss owners of Avastin, one of the world's highest-grossing cancer drugs, are off the hook for allegedly downplaying safety concerns about the drug to increase profits, a federal judge ruled.

Relator Gerasimos Petratos, the former global head of healthcare data analytics for Genentech Inc., F. Hoffmann La Roche Ltd., Hoffmann-La Roche Inc., and Roche Holding Ltd., filed a qui tam action against the firms on behalf of the federal and various state governments.

The defendants own Avastin, a drug that deters the growth of tumor-feeding blood vessels, which the Food and Drug Administration approved in early 2004 as a treatment in combination with chemotherapy for patients with metastatic colon or rectum cancer, Petratos claims.

But the agency's oncologic drugs advisory committee, concerned with clinical trial data, recommended denial of Avastin for metastatic breast cancer treatment in late 2007, Petratos says.

The defendants allegedly knowingly based their FDA submissions on inadequate patient databases that did not use electronic medical records to determine Avastin's real-world risks.

Petratos says that though he recommended in early 2010 that Genentech and Hoffmann La Roche use a better database that used both in- and outpatient data to reflect actual Avastin side effects, some employees and execs declined to examine it due to too much "business risk."

Though a study linked Avastin to proteinuria, or excess protein in urine that may damage the kidneys, the defendants withheld the data from Dr. Richard Lafayette, a "key opinion leader" in prescription practices, the complaint states.

Studies ultimately showed by the end of that year, no extension of lifespan and serious side effects from Avastin, so the FDA removed breast cancer as an approved use, Petratos says.

Genentech and Hoffmann La Roche also intentionally supplied the Center for Medicare and Medicaid Services data projecting significantly reduced annual costs associated with Avastin's side effects, in order to maximize profits, the complaint states.

Indeed, Avastin's 2010 revenues were about $6.5 billion, according to the complaint.

Petratos says Genentech and Hoffmann La Roche have underreported side effects facing at-risk patients, including higher rates of cardiac arrhythmia, kidney failure, pulmonary and cranial hemorrhages, and microangiopathic haemolytic anaemia.

He seeks hundreds of millions of dollars in damages under the False Claims Act and 28 states' analogous laws.

Genentech and Hoffmann La Roche moved to dismiss the suit.

U.S. District Judge Madeline Cox Arleo in Newark granted the motion on Oct. 29.

"The amended complaint is clearly deficient," Arleo wrote. "It does not allege any facts to show that CMS would find Avastin not to be medically reasonable and necessary for any particular use in the but-for world. This is fatal to plaintiff's claim that some doctors would not have prescribed Avastin had they been given more information about its risks. Plaintiff does not allege that CMS would have changed its reimbursement schedule or that any compendia would have changed its indication from supporting to non-supporting or to opposing use for any given indication. Thus, Avastin would have legally still been reasonable and necessary for the uses at issue. Plaintiff has not alleged any false claim based on the 'reasonable and necessary' requirement."

Petratos failed to allege that the FDA would not have approved Avastin, the ruling states.

"A false statement is not the same as a false claim for payment," Arleo wrote. "Congress used particular words, and this statutory scheme is not a broad-based consumer protection statute designed to punish generalized wrongdoing. The allegations in this complaint do not include any allegations showing any false claim for payment was ever made. Therefore, these claims are dismissed."

The parties have yet to respond to a request for comment.

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