Latest Drugwonks' Blog
From the editorial page of the Wall Street Journal ...
Kathleen Spitzer
The Administration targets a drug CEO in a troubling precedent.
Health and Human Services Secretary Kathleen Sebelius made her political name in Kansas, though we wonder if she's getting special advice from Eliot Spitzer. Her department's latest attack, on the CEO of Forest Laboratories, is straight out of the former New York Attorney General's bullying playbook.
Forest Labs entered into a federal plea agreement in September over misconduct in its marketing of antidepressants Celexa and Lexapro. The allegations were among a rash of government suits claiming that marketing to doctors common among drug companies amounted to fraud against Medicare and Medicaid. The charges were odd given their implication that major companies would be dumb enough to try to hoodwink their biggest customer.
The charges also had a political flavor as an attempt to blame drug companies, rather than the fee-for-service design of the federal programs, for runaway costs. But some companies including Forest chose to settle rather than engage in extensive litigation.
In any case, the federal complaint contained no suggestion that Mr. Solomon was involved with, or even aware of, misconduct. And the question of his continued leadership was never part of the plea deal.
Only after a federal court ratified the deal in March did HHS drop its intent-to-ban bomb. Mrs. Sebelius unearthed a dusty provision in the Social Security Act that allows officials to bar executives of health companies from doing business with the government when the firms are guilty of criminal misconduct.
The feds have rarely invoked this awesome power, given the potential for coercive abuse. But Mrs. Sebelius seems bent on making it more common policy and says she can employ it even against executives who had no knowledge of an employee's misconduct. A year ago Mrs. Sebelius used it to dismiss the CEO of a small drugmaker in St. Louis.
This is a threat to every health CEO in America. If Forest wants to continue to sell its drugs to Medicare, Medicaid and the Veterans Administration—the biggest buyers of pharmaceuticals—it will have to change management. Losing the federal government as a customer is potentially crippling to a drug company.
HHS says its action is about holding corporate CEOs accountable, but it looks more like the Administration's latest bid to intimidate the health-care industry into doing its bidding on prices, regulations and political support for ObamaCare. This is the same agency that has threatened insurers with exclusion from new state-run health exchanges if they raise their premiums more than Mrs. Sebelius wants, or if they spread what she deems to be "misinformation" about the President's health bill.
The hammer on Forest Labs "reinforces everybody's worst fears—that this Administration won't do business with anybody that doesn't completely agree with its policy initiatives. Not only will it refuse to even have the argument, it will actively destroy these people," says Peter Pitts, a former Food and Drug Administration official who now runs the Center for Medicine in the Public Interest.
The precedent here is also a recipe for much more litigation. Regulators aren't above bringing flimsy cases, and corporations often settle them simply to avoid huge legal bills and additional public relations risk. If the Obama Administration intends to view every such settlement as an admission of guilt and then dictate who can run the company, you can expect a lot more litigation.
Forest Labs is sticking by Mr. Solomon, saying the exclusion is "unjustified." But even the company has acknowledged that if Mrs. Sebelius implements her ban, Mr. Solomon would be forced to step down at least temporarily while the company takes her to court. Every CEO in America will get the message that his job is at risk if he quarrels with an Administration's bureaucratic orders.
This reminds us of a similar exercise by the Justice Department against former General Re CEO Joseph Brandon. Mr. Brandon cooperated in an investigation into a 2000 reinsurance transaction between Gen Re and AIG. But the feds leaned on Warren Buffett, the chairman of Gen Re parent Berkshire Hathaway, to fire him. Mr. Buffett praised Mr. Brandon but still sacked him in 2008, though later the feds closed the case with no action against Mr. Brandon.
CEOs are accountable for their actions, but it is simply unjust for a powerful regulator like Mrs. Sebelius to threaten a company with ruin if it doesn't dismiss a CEO who has had no formal charges or proof of wrongdoing brought against him. It's another example of how this Administration views private companies as little more than agents of greed that must be made examples of when the political need arrives.
PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers
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BioCentury reports that, per meeting minutes released by the FDA on Thursday and Friday, the agency and industry have an agreement for PDUFA V. On the financial front, "Industry agreed to include the $65 million in additional fee revenues for drug safety in FY 2012 in the base fee revenue amount for PDUFA V.”
Next step is for the FDA to hand its draft PDUFA V recommendations to the White House for review. Then, if all goes according to plan, the agency hopes to transmit its final PDUFA V recommendations to Congress on Jan. 15, 2012.
And yet, curiously, CDER Deputy Director Doug Throckmorton (PS/one of the smartest and hardest working guys at the agency) announced that the FDA will hold a PDUFA Public Meeting in September to get more input.
Hm.
On a separate but related note, the FDA has begun a review of its regulatory operations to determine if they can be made more effective. The agency is requesting comments on whether existing rules are "outmoded, ineffective, insufficient, or excessively burdensome."
Ya think?
The review is being conducted in response to an executive order issued by President Obama in January and the deadline for comments is June 27.
So stop griping and start typing.
Jamie and the Love-ites are on a quest to co-opt the debate over the growing problem of non-communicable diseases in the developing world to further their own anti-IP agenda.
Consider this new article from Intellectual Property Watch (Note – all bolded portions have been so noted by me):
Non-communicable diseases such as cancer and diabetes now have a global reach, and are the leading cause of death, according to the World Health Organization, which describes them as an “epidemic.” Once considered problems of rich countries, they now hit low- and middle-income populations the worst, says WHO, but preventive actions could be taken. Meanwhile, civil society is warning about the lack of availability of medications to treat non-communicable diseases in developing countries.
In the battle of rhetoric, the anti-IP community has co-opted the term “civil society” for themselves. Don’t be fooled by the Mahatma-sounding moniker.
In an effort to address this, WHO will launch its Global Status Report on Non-Communicable Diseases (NCDs) tomorrow, at its first global forum on the subject, being held in Moscow on 27 April.
The global forum brings together stakeholders to “share views and experiences to date on the challenges and opportunities” in NCDs, in particular for their prevention, treatment and control.
One of the objectives of the forum is to understand expectations, roles and contributions of different stakeholders in support of the September 2011 United Nations High-Level Meeting on NCDs. Another objective is to mobilise a “broader base of stakeholders in support of NCD prevention and control, in particular in developing countries,” WHO said.
And “stakeholders,” in case you were wondering, does not mean the pharmaceutical industry.
Following the global forum, the WHO is holding a first Global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control, co-organised with the Russian Ministry of Health, according to a WHO press release.
The conference seeks to assist an ongoing international campaign to “curb the impacts of cancers, cardiovascular disease, diabetes and chronic lung diseases,” and support member states’ efforts to develop policies and programmes on healthy lifestyles and NCD prevention.
Can you say, “compulsory licensing?”
The goal of the conference is to highlight the scale of NCDs and their socio-economic impact, to review international experience on prevention and control, and to provide evidence on needs to boost prevention “as part of national health plans and sustainable development frameworks.”
Can you say “Thailand?” Can you say “Brazil?”
A group of six nongovernmental organisations submitted recommendations to WHO member states prior to the meeting. They are calling for “affordable, appropriate, and good quality medicines, vaccines and diagnostics to persons suffering from NCDs in low- and middle-income countries,” according to the recommendations.
And yes – it’s the usual suspects.
Knowledge Ecology International, Médecins Sans Frontières, Oxfam, Third World Network, Universities Allied for Essential Medicines, and Young Professionals Chronic Disease Network described a shortage of NCD medications in developing countries, even for medicines that are off-patent. Generic medicines production is threatened, they said, as developed countries are seeking to include data exclusivity in free trade agreements with developing countries.
See – they buried the lead.
In particular, they recommended safeguarding generic production as the most effective way to lower prices, and for member states to use flexibilities enshrined in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Sound familiar?
The groups also advised incentivising research and innovation, and called on countries to: adopt strategies which de-link the cost of medicines from the cost of research and development, and apply the concept of prizes as an incentive for innovation in cancer treatment. They also called for the provision of funding to study the feasibility of cancer prize funds in both developed and developing countries. And the NGOs asked for quality assurance so that medicinal products meet WHO quality standards.
Ah yes, the famous “prize” idea. The same idea that has failed everywhere it has been tried – most famously in Soviet Russia. For more on this idiocy, see here.
The complete IP Watch article can be found here.
Danger Will Robinson. Danger.
Forest is sticking by its chief. "No one has ever alleged that Mr. Solomon did anything wrong, and excluding him [from the industry] is unjustified," said general counsel Herschel Weinstein. "It would also set an extremely troubling precedent that would create uncertainty throughout the industry and discourage regulatory settlements."
From the Wall Street Journal -- many important lessons to be learned -- as well as one really cool name: Merit Cudkowicz.
ALS Study Shows Social Media's Value as Research Tool
A new clinical trial found that lithium didn't slow the progression of Lou Gehrig's disease, but the findings released Sunday also showed that the use of a social network to enroll patients and report and collect data may deliver dividends for future studies.
The study was based on data contributed by 596 patients with the disease, formally called amyotrophic lateral sclerosis or ALS. By showing that the drug didn't have any effect on progression of the condition, it contradicted a small study three years ago that suggested such a benefit was possible.
The new study, published online in the journal Nature Biotechnology, represents an early example of how social networking could play a role in clinical trials, an area of medical science with strict procedures that many would consider especially difficult to apply in the online world.
"The approach has tremendous potential,'' said Lee Hartwell, a Nobel Prize-winning scientist now at Arizona State University, and formerly president of the Fred Hutchinson Cancer Research Center. Standard clinical trials play a central role in the research enterprise of both of those institutions.
Dr. Hartwell, who wasn't involved in the study, said social-network trials aren't likely to replace conventional randomized, double-blinded, placebo-controlled trials, the gold-standard for generating medical evidence. But such trials have become so complicated and time-consuming that new models are needed, he said.
Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.
In many diseases, "sometimes the alternative is not our way or the old way. It is our way or it is not studied at all,'' said Dr. Wicks, the research and development director at PatientsLikeMe, a closely held health-data sharing company in Cambridge, Mass., that ran the lithium study.
More than 4,300 patients are on the PatientsLikeMe ALS site, where they frequently share information on how their disease is progressing and strategies they are using to fight it.
Jamie Heywood, chairman and co-founder of PatientsLikeMe, said the idea for the new study came from patients. After the 2008 paper reporting lithium slowed down the disease in 16 ALS patients, some members of the site suggested posting their experiences with the drug in an online spreadsheet to figure out if it was working. PatientsLikeMe offered instead to run a more rigorous observational study with members of the network to increase chances of getting a valid result.
The company developed a tool to standardize collection of patient data, including lithium blood levels in patients. They used a questionnaire from conventional ALS trials to gather patients' self-reported data on functions such as swallowing, walking, and breathing.
In conventional studies, patients are randomly assigned to a treatment or control group to reduce sources of bias. Neither doctors nor patients know who is getting the drug.
In the on-line study, patients decided themselves if they wanted to take lithium. They needed to persuade a doctor to write a prescription. They were also able to see on the website how others taking the drug were faring in real-time. All of this raised chances that the study could lead to a false conclusion.
To address the concern, PatientsLikeMe developed an algorithm that matched 149 patients taking lithium with at least one other ALS patient on the site who didn't take the drug. A total of 447 patients were among this group that researchers considered controls.
The study didn't find any difference in disease progression a year after treatment between those taking lithium and the control group, researchers said.
Mr. Heywood said the result was apparent nine months after the study was launched. Conventional trials typically take more time just to enroll patients, he noted. Costs for drugs and recruiting patients were avoided.
Merit Cudkowicz, an ALS researcher at Harvard Medical School who was an investigator on a standard lithium clinical trial, said social network-generated data can offer valuable insights, but she cautioned that the PatientsLikeMe study was not a substitute for more rigorous studies. Two conventional on-going ALS studies are designed to see if lithium has a very small effect on survival, something the PatientsLikeMe study wouldn't be able to pick up.
"The thing you don't want to do in a fatal illness is to throw out potentially good drugs that might have small but meaningful effects,'' she said.
| Standard Clinical ALS lithium trials | Social Network ALS lithium trial |
Speed | About a year and a half to design and recruit. Additional time to analyze data | Nine months to design, recruit and present preliminary results |
Recruitment | Patients are recruited via doctors, usually at specialist centers in urban areas | Patients self-select through the Internet, regardless of where they live |
Control Group | Patients randomly selected to receive placebo | Patients selected by closeness in historical progression of the disease |
Data Openness | Group data are published | Group and individual data are made available online |
Source: PatientsLikeMe, WSJ research
Write to Amy Dockser Marcus at amy.marcus@wsj.com
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
