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Shedding Light in the Darkness

Drug Company Extortion in the U.S. and Europe

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A news story this morning on National Public Radio reported on the American Society of Clinical Oncology setting up a database of cancer drugs, which included a score for each drug based on how well a drug worked and how much it cost.

The database includes a lung cancer drug made by Eli Lilly, called Pemetrexed, sold under the brand name Alimta. It scored a zero, meaning it didn’t work any better than the standard treatment, and the cost was 10 times more expensive than the standard treatment. The cost – $90,193 per month. Alimta was Eli Lilly’s best seller last year, and it brought in revenues of $2.8 billion.

Cancer drug costs are steadily increasing over time, with some approaching nearly $40,000 per patient per month in 2014 dollars. The average monthly cost of a branded cancer treatment has more than doubled to $10,000 over the past decade.

A 2013 study found US cancer patients to be nearly three times more likely to experience bankruptcy than people without cancer.

Seven U.S. drugs cost more than $100,000 annually, and four of these drugs are used in cancer treatment.And the United States spends $37.2 billion annually on cancer drugs and supportive therapies, more than 40% of worldwide expenditures.

According to the American Society of Clinical Oncology, among the most expensive cancer drugs, Ranibizumab injections (sold as Lucentis) used to treat macular degeneration, costs Medicare more than $1,300,000 per year.

In the U.K. it costs around £1,000 ($1,550) a shot. The cost is lower because the U.K.’s health department can directly negotiate prices with drug companies, unlike Medicare in the U.S.

In 2013, Novartis, the company responsible for commercialization of the drug outside the U.S., reported international Lucentis sales of $2.38 billion. Roche’s Lucentis raked in $1.7 billion in U.S. sales in 2014.

Another drug, Avastin, made by the same companies (Novartis and Genentech – a subsidiary of the Swiss pharmaceutical conglomerate Hoffman-La Roche), could be used for the same condition. It only costs about $55 per injection. Lucentis has been approved by the FDA to treat eye disorders but Avastin hasn’t. So doctors have been prescribing it for off-label use.

“Lucentis is Avastin — it’s the same damn molecule with a few cosmetic changes,” J. Gregory Rosenthal, a Toledo ophthalmologist and co-founder of Physicians for Clinical Responsibility, told The Washington Post. “Yet Americans are paying a billion dollars every year for no good reason — unless you count making Genentech rich.”

In 2012, a South Florida ophthalmologist, Dr. Salomon Melgen, received nearly $21 million in Medicare payments. He billed for more than 37,000 doses of Lucentis.
A study in the journal Health Affairs reported the U.S. could save almost $3 billion a year if Medicare patients were given Avastin instead of Lucentis.  “Genentech doesn’t want you to use Avastin,” said David Hutton, the lead author of the study in an interview. “So they’re never going to go through FDA approval for its use in the eye.”

The company has no plans for a clinical trial program to evaluate Avastin’s use for eye diseases, a spokesman told Bloomberg.

According to the British Medical Journal, Roche refused to study Avastin as an eye treatment, despite pleas from U.K. officials. It noted how Novartis scrambled to protect its U.K. Lucentis sales as publicly funded, head-to-head trials were planned and launched, and continued to fight back as study authors deemed Avastin a cost-effective alternative to Lucentis.

“Doctors in England’s NHS have been left seemingly unable to prescribe a cheap, safe, and effective drug despite its flourishing use elsewhere in Europe and the US,” the BMJ article’s author wrote in April.

A report in the New England Journal of Medicine, concluded that Avastin administered monthly or as needed was equivalent to Lucentis administered monthly or as needed respectively.

In 2010, The New York Times reported that Genentech was offering secret rebates to eye doctors to encourage them to use Lucentis.

Italy sued Roche and Novartis over Lucentis for colluding in directing patients toward the more expensive medicine. In 2014, an Italian regional court upheld charges levied against the companies fining Roche and Novartis $221.6 million for manipulating sales of their eye medication.

French authorities also announced that they had been investigating the Lucentis-Avastin controversy since 2012. The French Competition Authority raided Roche and Novartis’ local offices to gather evidence of collusion.

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