There was a time in this country when European-style health care served as a cautionary tale. Today it is beginning to look like something to envy.
Future generations wishing to identify the moment the shift took place should look to Dec. 16, 2010. That was the day the U.S. Food and Drug Administration ruled to deny American breast cancer patients access to a blockbuster new drug – and the day the European Commission ruled to keep it on the shelf.
The drug in question is Avastin, one of the most promising treatments to emerge in the fight against breast cancer in years. By cutting off blood flow to tumors, Avastin can stop their growth or even shrink them. Clinical trials have shown Avastin to be effective for about 50 percent of women suffering from breast cancer, some- times extending their lives by years.
So why take it away? Avastin initially was granted approval in 2008 under the FDAs fast-track program, which speeds promising drugs to market. But the program also requires that drug companies continue testing to make sure the drugs can deliver on their promises. The FDA took issue with the results of one of Avastins studies – based on a deeply flawed interpretation, no less – and decided to revoke its approval for the breast cancer drug.
Thats the official explanation. But critics of the FDAs decision – and they are legion – point to the high cost of the drug, which can run up to $90,000 annually.
Of course, the FDA isnt supposed to take factors like cost into consideration when approving medicines. But its hard to make a case that it didnt play a role here. Jean Grem, a member of the FDA’s Oncology Drug Advisory Committee, already gave up the ghost when she stated during her panels meeting, We arent supposed to talk about cost, but thats another issue.
Meanwhile, on the same day that the FDA was eliminating Roches wonder drug as an option for American cancer patients, the European Commission affirmed its commitment to it. Avastin was under the same regulatory pressure overseas that it was in the United States, but the Europeans declared that the drugs benefits greatly outweigh its risks.
In America, the FDA justified revoking Avastins approval, in part, on the grounds that it didnt significantly extend life for the average patient.
That argument is unfair given that Avastins initial approval was not based on this overall survivability metric, but on the drugs ability to provide progression-free survival (about 5.5 months) and dramatically shrink tumors in super-responders.
This withdrawal could cause both public and private insurers to start rescinding coverage for Avastin in the treatment of breast cancer. This is precisely the kind of backdoor rationing that critics of Obamacare have warned about.
Unfortunately, the Roche drug is not the only cancer treatment in jeopardy because of its cost. Medi- care is weighing whether to pay for Provenge, a drug used to combat advanced prostate cancer that costs about $93,000 a year. A panel of outside experts agreed in November that Provenge was an effective treatment that should be paid for. But Medicare, which, like the FDA, isnt supposed to consider cost when deciding which drugs to pay for, is still making up its mind.
There is still hope for Provenge, as there is for Avastin. Roche is appealing the FDAs decision, and a ruling is expected this summer. Breast cancer advocates have flooded the agency with petitions and complaints, and the patients themselves have provided passionate testimony about what Avastin has done for them.
The FDA needs to understand that its decision on Avastin matters to more than just cancer patients. Pulling approval for a drug that has proved effective because it doesnt fare well under the agencys morbid analysis sends the wrong signal to American drug companies. Innovation shouldnt be stifled because breakthroughs could bust the budget. American-style health care should be a model for countries around the world, not a cautionary tale for Europeans.