Over at NEJM, my perspective piece on Tobacco and the First Amendment went online last night. In a pair of federal lawsuits, most of the tobacco industry is challenging the new FDA graphic warnings and package allocation rules, which together require the top 50% of the front and back of all cigarette packaged to bear striking images of tobacco’s health effects.
This is yet another example of powerful global corporations using the First Amendment to attack public health regulations. Australia has introduced plain packaging rules for cigarettes, which the companies are challenging under a bilateral investment treaty.
For the full story, plus a slide show of the graphic images, see the NEJM.
In the Philips Electronics & Nokia cases, the European Court of Justice recently affirmed that patents and trademarks are not enforced against goods in-transit through Europe (C-466/09). European IP owners are unhappy with the ruling and some academics are unhappy as well (IPKat, for example). The EC has been working on a new tougher Regulation for some time (see Vrins’ article in JIPL&P 2011). But for global health, this is the right ruling.
In 2009, generic drugs were shipped from India to Africa and Brazil. Sometimes the most direct route isn’t the cheapest, so these drugs ended up “in-transit” in the Netherlands on their way to Africa and Brazil. The drugs fully complied with all intellectual property laws in India and Brazil, but the patents had not yet expired in Europe. The Dutch authorities seized the drugs and triggered a firestorm. (MSF letter here; my related academic paper here). If these drugs had been destined for sale in Europe, they would have infringed the patents and trademarks. But they were just moving through a port in the global stream of commerce.
Global IP law recognizes that IP rights are territorial, and that each country will apply patent, trademark and copyright rules somewhat differently. Law can protect the companies’ legitimate expectations of profits in wealthy countries without blocking global trade in fully legal generic medicines.
Bloomberg reports that Walgreens, Krogers, Safeway and other stores are suing Wyeth and Teva for conspiring to keep a generic version of the Effexor XR antidepressant off the shelf by buying junk patents, adding them to the Orange Book and suing to block generic entry with full knowledge the patents were not being infringed. Teva is in the suit as it was the first to file for generic status and agreed to a “pay for delay” deal (FTC background paper here; Scott Hemphill’s academic paper here).
Drug companies call these activities “product lifecycle management.” This case alleges it is a violation of the Sherman Antitrust Act. I pulled the complaint from PACER, which alleges Wyeth made $2.5 billion from these sham patents:
“11. As a result of Defendants’ exclusionary conduct, generic versions of Effexor XR were illegally blocked from the marketplace from June 2008 through at least June 2010. During this period of foreclosure, U.S. annual sales of Effexor XR topped $2.5 billion. Direct purchasers paid significantly more for extended release venlafaxine hydrochloride capsules during this two year window (and continue to pay more for Effexor XR and its generic equivalents) than they would have paid in the absence of Defendants’ illegal and anticompetitive acts.”
The complaint alleges that Wyeth defrauded the US Patent and Trademark Office in order to abuse the FDA Hatch-Waxman process:
“46. Wyeth submitted six sequential applications that led to three method of use patents, the ‘171, ‘958, and ‘120 patents. All three patents are, and have always been, unenforceable; they only issued because Wyeth defrauded the PTO. These patents prevented generics from coming to market in June of 2008.”
In addition to the drug stores, the suit is also brought “as the assignee” of the big 3 drug wholesalers – Cardinal Health; AmerisourceBergen; and McKesson. What will they say about Merck Pfizer’s lifecycle extension plans for Lipitor?
What happens when an unstoppable force meets the immovable object? The Governor threatens to pass a law.
Duopoly Bilateral monopoly litigation between the largest health system and the largest insurer in western Pennsylvania is turning into a nasty battle. An update from KHN:
Last week during a speech at the Pennsylvania Press Club in Harrisburg, Gov. Tom Corbett said he’s “deeply” concerned.
“In my mind, they are both charities and they are both nonprofits and something is getting lost in between,” he said. “And I will work with the Legislature, if necessary, to address this.”
The real story here is that Highmark tried to inject some competition into the Pittsburgh market for health care services. Usually the duopolists bilateral monopolists get along just fine, to the detriment of consumers.
For a round up on most pending major health care antitrust litigation, including this case, see my TIE post from June.
My summary: If a provider is clinically integrated enough to qualify as a Medicare ACO, that’s good enough for antitrust law too. From the October 20, 2011 DoJ/FTC joint Final Statement:
The Agencies have determined that CMS’s eligibility criteria are broadly consistent with the indicia of clinical integration that the Agencies previously set forth in the Health Care Statements and identified in the context of specific proposals for clinical integration from health care providers. The Agencies also have determined that organizations meeting the eligibility requirements for the Shared Savings Program are reasonably likely to be bona fide arrangements intended to improve the quality, and reduce the costs, of providing medical and other health care services through their participants’ joint efforts.
In other words, familiar health care antitrust rules will apply. As for safe harbors, an ACO will be considered “highly unlikely to raise significant competitive concerns” if institutional providers participate non-exclusively and the combined market share is 30% or less. Behavior the government hopes to discourage includes:
Blocking commercial payers that want to direct or incentivize patients to choose certain providers;
Tying sales of ACO services to sales of other services (ie, the ACO cannot require health plans wanting ACO services to contract with all of provider’s network for non-ACO services);
Contracting with ACO non-primary care physicians, hospitals, ASCs, or other providers on an exclusive basis (only primary care docs can be exclusive);
Restricting a commercial payer’s ability to provide cost and quality performance data and information to its enrollees; and
Sharing sensitive price information amongst competing ACO members.
All very sensible; as we’ve said before, ACOs raise competitive concerns and don’t need special antitrust exceptions.
While the NYT trash-talks legal education, medical schools are revising the MCAT to “reward candidates who have read broadly in the liberal arts and can think analytically.” This is a change.
This new focus aims to encourage aspiring physicians to come to medical school having considered what makes us human, how we interact with other human beings, and how human behaviors have shaped civilizations and society.
The MCAT revision complements efforts by some medical schools to reserve a portion of their classes for humanities students who lacked traditional pre-med education as undergrads. Not to put too fine a point on it, but stellar success as a pre-med may not correlate perfectly with the social skills needed to be an excellent primary care doctor.
One program, the Mt. Sinai Humanities and Medicine Program, has reported encouraging results:
Results: There were no statistically significant differences between the groups in clerkship honors other than psychiatry (HuMed students outperformed their peers, P < .0001) or in commencement distinctions or honors. Although HuMed students were significantly more likely to secure a scholarly-year mentored project (P = .001), there was no difference in graduating with distinction in research (P = .281). HuMed students were more likely to have lower United States Medical Licensing Examination Step 1 scores (221 ± 20 versus 227 ± 19, P = .0039) and to take a nonscholarly leave of absence (P = .0001). There was a trend among HuMed students toward residencies in primary care and psychiatry and away from surgical subspecialties and anesthesiology.
Conclusions: Students without the traditional premedical preparation performed at a level equivalent to their premedical classmates.
“The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.”
It wasn’t the government that delivered the blow. Genentech was the company that marketed a drug for billions of dollars to desperately ill women. A drug that we now know does not work, according to the best evidence we have at present. Don’t blame the FDA.
Banning use of Avastin for metastatic breast cancer;
Punishing doctors who use it off-label;
Banning reimbursement for off-label use; or
Making a death panel decision based on inadequate scientific evidence.
Journalists & bloggers – no excuse for making these mistakes (again).
If you have questions about the FDA action, please read the key NEJM study first. Then read the FDA’s 69 page review of the scientific evidence. We’re interested in data here at TIE, so comments are welcome about the validity of the evidence base on this question.