There is an unexpected result that came with the passage of Obamacare. Well is was unexpected for those outside the Obama Administration. With the passage of his signature bill, Obama and his minions have demanded control of the Healthcare message.
In today’s WSJ, Scott Gottlieb of the American Enterprise Institute sounds the alarm about legal action directed toward Pharmaceutical Executives who fail to “toe the line:”
A federal judge sentenced the former head of a biotech company to six months of home confinement this spring and fined him $20,000. His offense? Issuing a single press release about a drug.
Scott Harkonen is the former CEO of InterMune, which marketed the drug Actimmune to treat a rare and deadly lung disorder called chronic granulomatous disease. However, most of the drug’s sales were to doctors who used it “off label” to treat a different fatal lung disease called idiopathic pulmonary fibrosis.take our poll - story continues below
In 2002, InterMune ran a large trial to seek Food and Drug Administration approval to sell the drug explicitly for this second disease. That study didn’t meet its primary goal: showing that the drug slowed progression of lung fibrosis. But the results did suggest that patients with “mild to moderate” fibrosis lived longer.
There were plausible reasons why the drug might work only in patients with mild disease and not those with advanced fibrosis. Yet some of the analysis that led to this conclusion was nonetheless “retrospective”—meaning statisticians had selectively mined the data to find that positive benefit.
Since the study didn’t set out to test the drug in only mild patients, the finding wasn’t firm enough to satisfy FDA. So when Dr. Harkonen subsequently issued a press release that publicized the study’s findings, the Justice Department says he committed the crime of wire fraud.
His real crime was simply hinting that a drug might be able to help people before HHS Secretary Sebelius had decided whether the drug was cost effected or not.
….At the same time government is limiting what private companies can legally communicate about their drugs, it has set a much lower standard for federal health agencies. President Obama has created new institutions with the sole mandate of running trials based on softer statistical standards. Retrospective studies will be the core occupation of a new “comparative effectiveness” research agency that has $4.1 billion to conduct government studies on medical products. The results will be used to inform federal treatment guidelines, as well as Medicare’s payment policies.
At least $100 million of that $4.1 billion is being spent on promoting research results. The Agency for Healthcare Research and Quality recently paid $26 million to the PR firm Ogilvy to “market and promote the adoption” of the findings.
The bottom line is that Washington is attempting to reduce health-care spending by constraining the speech of private firms that promote pricey drugs while promoting government research that discourages their use. The advance of medical practice will suffer if Washington can decide the standards for medical decision-making and control the flow of scientific information.
This behavior is not an unusual action for the Obama administration. Remember, last September, when Health Insurers sent out letters saying that prices are going up because of the Obamacare bill. They got a nasty letter from Secretary Sebelius The letter written in a threatening tone said in part:
Given the importance of the new protections and the facts about their impact on costs, I ask for your help in stopping misinformation and scare tactics about the Affordable Care Act. Moreover, I want AHIP’s members to be put on notice: the Administration, in partnership with states, will not tolerate unjustified rate hikes in the name of consumer protections.
Already, my Department has provided 46 states with resources to strengthen the review and transparency of proposed premiums. Later this fall, we will issue a regulation that will require state or federal review of all potentially unreasonable rate increases filed by health insurers, with the justification for increases posted publicly for consumers and employers. We will also keep track of insurers with a record of unjustified rate increases: those plans may be excluded from health insurance Exchanges in 2014. Simply stated, we will not stand idly by as insurers blame their premium hikes and increased profits on the requirement that they provide consumers with basic protections.
I suppose that’s just another benefit of Obamacare, along with higher insurance costs and making access to certain medical services more difficult, Obamacare has given the White House an excuse to threaten the first amendment rights of the insurance and pharmaceutical industry.