Aducanumab Approval, Part 2

So how did a drug with such dubious benefit get approved? At best, another clinical trial might be warranted, but certainly not approval. It's a result

1. of a huge campaign by a company (Biogen) that would not accept the failure of its drug
and
2. of pressure from patient organizations like the Alzheimer's Association (which receives major money from pharma, including Biogen and its Japanese partner, Eisai).

The company campaign began in spring 2019, after its Phase 3 trials were stopped for futility after an interim review. A long, detailed, and excellent STATnews article published this week, drawing on insider sources, tells a fascinating but troubling story. The last-ditch effort to get approval was originally called "Operation Phoenix," but was re-titled "Operation Onyx." Biogen managed to get Billy Dunn, Director of the Office of Neuroscience at the FDA, on their side, to the point that he worked closely with them to provide a roadmap for approval, very inappropriately.

After the groundwork was laid for an approval of aducanumab despite the negative advisory committee recommendation, and prior to the announcing of a final decision, the patient organization campaign was carefully timed. In early May, the Alzheimer's Association launched a big campaign seeking to build grassroots support for drug approval. The "More TIme" campaign worked to pull at heartstrings with celebrity endorsements and poignant personal stories. Full-page ads were taken out in the Wall Street Journal and USA Today, and focused on what "more time" would mean to Alzheimer's patients and their families. There were google search ads, Facebook and Twitter and Instagram and LinkedIn posts. The campaign succeeded in getting over a million people to express support in petitions.

After the approval, the Alzheimer's Association spoke of victory:

As the first FDA-approved drug that delays decline due to Alzheimer’s disease, the approval of aducanumab (Aduhelm™) is a victory for people living with Alzheimer’s and their families.

Comments on articles including this one give the flavor of the passion with which some people want to try this unproven therapy.

Denying a medicine which might work is far more worse than approving one that might not work! Do you agree in the case of Alzheimer’s?

The negativity of these old fashion mentality is what has driven new discoveries to a halt. I don’t suffer from Alzheimer’s nor know anyone close to have been dx w it but we need to start somewhere. Prescribing the pharma will only help w research. Get in line MD.

Alzheimer’s is a horrible disease. If the medicine has a chance of success then prescribe it.

And public officials seem to be buffaloed. A Politico article said that not only are public officials mute about the approval, they are hesitant even about making a fuss about the pricing (about which more in another post):

[Politicians are] worried they’ll be seen as dashing desperate patients’ hope for an Alzheimer’s treatment — even one that may provide little or no benefit. The FDA’s controversial approval of Biogen’s drug, known as aducanumab or Aduhelm, has caught both political parties flat-footed ...Everyone is a bit terrified by Alzheimer’s, so the average person hears about the FDA approval of a treatment, and they don’t know about the controversy over whether it works or not,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management who lambasted FDA’s Aduhelm approval. “They hear there’s a new treatment and, that’s great, it’s a sign of hope. Do you want to be the politician who says, ‘I want to take that away from you?’”

Evidently, the public opinion campaign with its drumming up of support for this bogus drug has had its desired effect, creating cowardice to speak about the realities. Subsequent to the publication of the Politico article, two senators did speak out about pricing, but were careful to praise the drug:

Even as they criticize the price, however, Cassidy and Warren still stopped short of directly criticizing Biogen. They offered praise for the drug’s approval, too, calling it a “historic, watershed moment” in the history of the disease.

Public Citizen - who does not have to get elected - did not share this hesitancy. Their long public letter to HHS Secretary Xavier Becerra - which I recommend reading in full - begins as follows:

Public Citizen is writing to express its outrage over the Food and Drug Administration’s (FDA’s) indefensible decision to approve Biogen’s aducanumab (Aduhelm) for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury. The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

They go on to ask for resignation of key officials in approving aducanumab, including FDA acting head Janet Woodcock and Billy Dunn. They also ask that the Office of the Inspector General for HHS investigate the relationship and "close collaboration" between the FDA and Biogen prior to Aduhelm approval. In addition, they want rescission of the bogus approval:

You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Those who pushed for approval seem eager to foreclose any discussions of rescission. In an interview, there was this question and answer with Acting FDA Head Janet Woodcock:

Question: "There’s been some reaction that every time this criticism comes up, the FDA just dismisses it outright and doesn’t really meaningfully engage on it —doesn’t do soul-searching. … Should the FDA do some soul searching? Should you and the FDA be trying to respond more directly to these critics?" Woodcock's reply: "I think we will have some more public soul-searching type of discussions on accelerated approval itself, but the soul-searching when a decision is made goes on before the decision, and once we’ve made the decision, we’ve made the decision."

Similarly, the head of the Alzheimer's Association wants to end discussion of the approval:

Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.”

But, if the aducanamab approval is not rescinded, what will happen and what are the consequences? More on that in another post.

FDA Approval of Aducanumab

Almost twenty years ago, I was a volunteer nursing-home ombudsman. The doctor at the nursing home I visited was a huge proponent of preventive therapies, and prescribed as many preventive drugs as possible for residents (while frequently ignoring complaints about current medical problems that were bothering them). Among the drugs he very freely prescribed were cholinesterase inhibitors for Alzheimer's disease, then fairly new. I was stunned when I learned he prescribed one to a resident whom I knew well and who seemed fully oriented to me, but that was the case. From what I've learned since, these drugs don't have any really noticeable clinical benefits anyhow, so they are unimpressive.

But if prescribing those drugs so freely seemed like a dubious course of action to me then, they look almost good now by comparison to the latest drug approved by the FDA for Alzheimer's disease, aducanumab (Aduhelm). This drug doesn't have any convincing evidence that it benefits patients, AND it comes with potentially serious side effects that require a lot of monitoring.

The quality of life implications of this are troubling. As one doctor notes:

"This is a drug that medicalizes someone’s life,” said Mantyh. Besides the hourlong, once-monthly infusions, an Aduhelm prescription comes with frequent lab tests and brain scans to monitor for signs of swelling or bleeding. In two of Biogen’s clinical trials, more than one-third of participants who received Aduhelm developed painful brain swelling; about 17% to 19% had small bleeds in their brains. Headaches, dizziness, nausea — all might trigger more time spent in the hospital. Such constraints could make it difficult to travel internationally or spend time with family members in other states.

The article also notes that, except in the case of adverse side effects, it is hard to decide when to discontinue a drug when it's likely to be quite unclear whether it's benefitting the patient or not.

How did the FDA come to approve this drug without stronger evidence that it is actually beneficial? It used an "accelerated approval" pathway and based the approval on the fact that the drug diminishes the size of amyloid plaques. This was despite the fact that in multiple trials. reducing amyloid plaques has not been shown to improve things clinically for patients. As Derek Lowe wrote (and his whole post is well worth reading):

So the FDA has, for expediency’s sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed. I really, really don’t like the precedent that this sets: what doesn’t get approved, now? I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit?

A commenter on the Lowe blog ("Radioactive Man") wryly noted:

All the other companies that successfully developed anti-amyloid drugs then discontinued them for lack of efficacy must be kicking themselves to realise they were approvable all along. It makes me wonder, could they just simply dust off their old phase 3 results and go straight to applying for approval without even doing any more clinical studies? If those results are comparable to aducanumab, why not?

Elsehere too, there was speculation on whether other companies could go back and now seek approval of similar drugs that cleared plaque without showing clinical improvement.

[Could] a slew of amyloid-reducing agents from the past...now be re-evaluated under the accelerated approval pathway?...In a public defense of her agency’s decision on June 22, Woodcock said future approvals under this pathway would be possible if the magnitude of plaque reduction was great enough.

Not one of the FDA advisory committee members voted to recommend approving aducanumab. Ten voted against, and one voted "uncertain." Three have since resigned in protest. In his resignation letter, one stated this is "was probably the worst drug approval decision in recent FDA history."

A professor who has served on many FDA committees commented:

“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson....“This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”

Despite the protests, proponents of the drug were breezy, lauding it as a great "breakthrough." The acting commissioner of the FDA, Janet Woodcock, said that she is “not that concerned” about criticisms of the approval. And meanwhile, the first patient got his first infused dose of aducanumab. Dr. Stephen Salloway, director of the memory and aging program at the Rhode Island hospital giving the infusion, stated at a press conference: "It's transforming how we treat Alzheimer's." He snottily added, "For those of you who don't know, it's a devastating disease."

Salloway's remarks make me really furious. A supposed medicine has to be judged by its results, not by the urgency or seriousness of the condition it is alleged to treat. And the "evidence" was totally cherry-picked post hoc after the failure of their Phase 3 trials, following the bad rule: "If you don't succeed, change the definition of success."

There's more to be said about the aducanumab approval, but this post is long enough. More in the next post.

Pharma's Dark Money: Touting Corporate Responsibility and Non-Partisanship, But Using Dark Money to Promote Self-Serving Policies and Partisan Causes

Health Care Corporations Promote Their Social Responsibility

The US health care system's extreme dsyfnctionality is now a cliche.  So it's no wonder that everyone seems to want to make things better.  Big health care corporations in particular tout their socially responsible ideas for health care reform.

For example, PhRMA, the trade organization for drug and biotechnology firms, describes its mission thus:

PhRMA is committed to advancing public policies in the United States and around the world that support innovative medical research, yield progress for patients today and provide hope for the treatments and cures of tomorrow.

Amgen states simply its mission is "to serve patients."

Biogen published a "Corporate Citizenship Report" which included

our commitment [is] to positively impact our communities, to inspire the next generation of scientists, to solve social and environmental challenges and to create a diverse and inclusive workforce that thrives professionally and personally.

Giant pharmaceutical/ biotechnology/ device company Johnson & Johnson has its famous "credo" which starts with

We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.

Furthermore,

We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens – support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education.

 
With all that positivity supporting better health care, one would think that health care dysfunction should be soon gone. But maybe under all this talk about corporate responsibility lies something darker.

An Early Case of Dark Money in Health Care

Back in 2012 we discussed a case of "dark money" being used to conceal sources of support for particular health policy and political positions.  The case was of the Center for Protection of Patient Rights, an obscure group whose mission was to "protect the rights of patients to choose and use medical care providers."  The CPPR financed the US Health Freedom Coalition, led by Dr Eric Novack, which received nearly its entire budget — $1.7 million — from the center to help pass a state ballot measure that aimed to block President Obama's healthcare overhaul.  The Center ultimately transferred $55 million to Republican candidates in the 2010 election.  Its money came from the equally obscure Americans for Job Security, and was conveyed by groups such as the American Future Fund. The people who gave the money to the Americans for Job Security remained unknown, save for one wealthy Alaskan "landowner."  

Do Health Care Corporations Put Their Money Where Their Mouths Are?


This year, we discussed the case of huge pharmacy chain CVS,which proclaims its "social responsibility," and its policy of only making charitable contributions to improve "health and healthcare nationwide."  Yet CVS was donating to America First Policies, a supposed non-profit group devoted to promoting the partisan agenda of President Trump, including "repealing and replacing Obamacare," and immigration policies such as building the "wall" and deporting  "illegal immigrants."  America First Policies appears to be yet another dark money organization.  CVS only decided to stop contributing when journalists revealed that America First Policies staffer had made flagrantly racist and pro-Nazi comments.

This suggested that it is possible that health care corporations which promote themselves as socially responsible and non-partisan may actually be secretly promoting political agendas that might shock some of their consumers and/or patients, employees, and health care professionals who must deal with them. 


We have  now found some more cases that reinforce this suspicion, showing how pharmaceutical and biotechnology companies have funneled funds through more "dark money" organizations to support policies that do not fit so well with the image they want to convey.

The PhRMA Backed Dark Money Campaign Against an Ohio Initiative to Control Drug Pricing

In August, 2017, the International Business Times revealed how the pharmaceutical/ biotchnology industry had set out to defeat a 2017 Ohio initiative meant to hold down drug prices without revealing who was funding it.

PhRMA had already succesfully defeated a similar initiative in California in 2016.  However, industry support for this campaign, while obscure, was not a secret. 

PhRMA set up ... Californians Against the Misleading Rx Ballot Measure, which raised over $111 million for its campaign against a California initiative that ... would have blocked that state from paying higher drug prices than those negotiated by the Veterans Affairs Department. The trade group set up a political action committee in California to which pharma companies donated directly — so PhRMA had to disclose these donors. Merck, Pfizer and Johnson & Johnson gave over $9 million each; Amgen gave $7.6 million; and 19 other drug companies gave $1 million or more. The PhRMA-run committee spent nearly all of the millions it raised, and the measure failed to pass, with 53 percent of voters shooting it down. All donors except for Genentech and Gilead Sciences are PhRMA members, and only a handful of companies out of more than 30 total corporate donors are headquartered in California.

Somehow, with all the news coming out about the 2016 US elections, this generated little interest.  However, in Ohio in 2017, PhRMA was able to do something similar while keeping the corporate sources of the money hidden.  Their target was:

Issue 2, the Ohio Drug Price Relief Act — a citizen-initiated ballot measure designed to prevent state agencies, including the state Department of Medicaid, from purchasing drugs at rates any higher than the lowest amount paid by the federal Department of Veterans Affairs, which negotiates with drug companies and saves between 20 and 24 percent on drug costs.

This time:

Pharmaceutical Research and Manufacturers of America (PhRMA), the biggest trade organization in the U.S. representing major drug companies, created a political action committee on May 1 called Ohioans Against the Deceptive Rx Ballot Issue. On the same day, PhRMA also founded a limited liability corporation of the same name and registered at the same address; under normal circumstances, it would not be required to disclose its donors. Campaign finance reports document only one donor to the ballot measure committee: the linked LLC.

So contributions from corporate donors to the LLC to financeed the political action committee were concealed.  So,

'Certainly, setting up an LLC to launder drug company money into fighting the ballot measure looks like an effort to evade Ohio's transparency and disclosure laws,' Brendan Fischer, director of federal and Federal Election Commission reform at the nonpartisan Campaign Legal Center, told International Business Times in an email.

Also,

The Campaign Legal Center contends that hiding donors this way at the federal level violates the Federal Elections Campaign Act, which prohibits 'straw donors.'

There were only two flies in the ointment.  Two companies did disclose donations to the LLC:

According to the Columbus Dispatch, California-based Amgen gave $6.3 million from 2016 through June 2017, and Biogen, headquartered in Massachusetts, gave $1.5 million last year. This accounts for roughly half of the $15.8 million total that PhRMA’s LLC raised in just May and June to fight Issue 2.

Who donated the rest, amounting to some $58 million, remains unknown.  And the effort to defeat Issue 2 was succesful, as reported by Cleveland.com in November, 2017.

Issue 2 also now holds the distinction of being the most expensive ballot issue in state history, with more than $74 million raised over the course of three years, topping the $64.4 million spent on Issue 6 in 2008, which sought permission for a casino in Wilmington, Ohio. Issue 6 also failed at the ballot.

Big Pharma accounted for more than $58 million of the total raised.

Furthermore,

Because the drug companies passed the money through a limited liability company created with the intention of funneling cash to the opposition campaign, it's currently impossible to tell which companies actively spent money combating the initiative in Ohio.

A proponent of Issue 2 charged:

'The onslaught, the bombardment of television advertising that was misleading, lying and negative led to tremendous confusion,' he said.

Uncertainty from the public about the effects of the bill coupled with the ugliness of the campaign likely led to Issue 2's defeat. Voters were often confused and felt both sides were of zero help in explaining the issue.

And by August 25, 2018, the Columbus Dispatch reported that all legal compaints against the PhRMA dark money campaign were dismissed.

Think of the campaign to defeat Issue 2 as a proof of the concept that health care corporations can finance campaigns against policy measures using dark money organizations to hide their support.

But no one would be surprised to find out that pharmaceutical companies were against a policy measure that would restrict the prices they charge.  Our next case shows how the dark money ruse can be used by corporations to support partisan policies that conflict with their proclaimed social responsibility and non-partisan nature.  

The PhRMA Backed Dark Money Campaign to "Repeal and Replace" the Affordable Care Act (ACA)

Investigative journalism from Kaiser Health News appeared in the New York Times and the Washington Post in late July, 2018 showing how PhRMA again used dark money, but this time to advocate for "repealing and replacing" the Affordable Care Act (known informally as "Obamacare"), which PhRMA had previously supported, and about which it was then ostensibly neutral.  The article began,

In 2010, before the Affordable Care Act was passed by Congress, the pharmaceutical industry’s top lobbying group was a very public supporter of the measure. It even helped fund a multimillion-dollar TV ad campaign backing passage of the law.

But last year, when Republicans mounted an aggressive effort to repeal the law, the group made a point of staying outside the fray. 'We’ve not taken a position,' Stephen Ubl, head of the organization, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, said in an interview in March 2017.

This was deceptive.

That stance, however, was at odds with its financial support of another group, the American Action Network, which was heavily involved in the effort to repeal the act, often referred to as Obamacare. The network spent an estimated $10 million on an ad campaign designed to build voter support for its elimination.

'Urge him to repeal and replace the Affordable Care Act now,' one ad running in early 2017 advised viewers to tell their congressman. That and similar material (including robocalls) paid for by the American Action Network ran numerous times last year in 75 congressional districts.

PhRMA was one of AAN’s biggest donors the previous year, giving it $6.1 million, federal regulatory filings show. And PhRMA had a substantial interest in the outcome of the repeal efforts. Among other actions, the Republican-backed health bill would have eliminated a fee the companies pay the federal government, one estimated at $28 billion over a decade.

But there was no way the public could have known at the time about PhRMA’s support of the network or the identity of other deep-pocketed financiers behind the group.

The KHN report went on to explain how this works

Unlike groups receiving its funds, PhRMA and similar nonprofits must report the grants in their own Internal Revenue Service filings. But the disclosures don’t occur until months or sometimes more than a year after the donation.

The conservative-leaning AAN has become one of the most prominent nonprofits for routing what is known as dark money — difficult-to-trace funds behind TV ads, phone calls, grass-roots organizing and other investments used to influence politics. Such groups have thrived since the Supreme Court’s Citizens United decision in 2010, which loosened rules for corporate political spending, and amid what critics say is nonexistent policing of remaining rules by the I.R.S.

Generally speaking, dark-money groups are politically active organizations, often nonprofit, that, under I.R.S. regulations, are not required to disclose the identities of their donors.

Such groups are often chartered under Section 501(c)(4) of the tax law, which grants a tax exemption to 'social welfare organizations.' For those seeking to influence politics but stay in the background, 501(c)(4) designations offer two big advantages: tax exemption and no requirement to disclose donors.

The AAN seems to be an obviously partisan, right-wing, pro-Republican group.

PhRMA’s $6.1 million, unrestricted donation to AAN was its single-biggest grant in 2016, dwarfing its $130,000 contribution to the same group the year before. Closely associated with House Republicans — AAN has a former Republican senator and two former Republican House members on its board — the group backed the failed G.O.P. health bill intended to replace the Affordable Care Act. It also supported the successful Tax Cuts and Jobs Act of 2017, which reduced corporate taxes by hundreds of billions of dollars over a decade.

So far in this election cycle, AAN has given more than $19 million to the Congressional Leadership Fund, a Republican super PAC with which it shares an address and staff, according to the Center for Responsive Politics. The fund recently ran ads opposing Democratic candidates in high-profile special congressional elections in Georgia and Pennsylvania.

In fact, PhRMA made a variety of contributions to dark money groups associated with right-wing and/or Republican party backed causes, while it presumably maintained a non-partisan public stance.

PhRMA gave nearly $10 million in 2016 to politically active groups, including AAN, that do not have to disclose donors, its most recent filing with the I.R.S. shows. By contrast, PhRMA and its political action committee made only about $1 million in political donations in 2015 and 2016 that were disclosed to regulators and reported by the Center for Responsive Politics.

PhRMA’s 2016 political activities included support for the Republican National Convention. Rather than directly support the Cleveland convention, which several companies pulled out of after it became clear that Mr. Trump was going to be the nominee, PhRMA routed $150,000 through limited liability companies with names like Convention Services 2016 and Friends of the House 2016.

Like 501(c)(4)s, LLCs do not have to disclose their donors. PhRMA’s support was revealed in I.R.S. filings more than a year later. (Donations by PhRMA and other groups to Friends of the House, which financed a luxury lounge for convention dignitaries, were first reported by the Center for Public Integrity last fall.)

PhRMA’s surge in donations to AAN coincides with the arrival of Mr. Ubl, who took over as president and chief executive in 2015 and has longstanding ties to Norm Coleman, a former United States senator from Minnesota who is now the network’s chairman. Mr. Ubl once ran the lobby for manufacturers of knee implants, heart stents and other medical devices, one of which, Medtronic, is based in Minneapolis.

Also,

PhRMA’s 2016 dark-money contributions included $150,000 to Americans for Prosperity, a conservative group associated with the billionaires Charles and David Koch. Their group has already signaled it will be active in November’s elections, running attack ads against Senator Jon Tester, a vulnerable Montana Democrat, for not supporting a repeal of the Affordable Care Act.

PhRMA also gave $50,000 to Americans for Tax Reform, run by the conservative anti-tax activist Grover Norquist.

In contrast, PhRMA gave lesser amounts to groups identified as centrist or left-leaning.

Mostly smaller amounts went to centrist and liberal groups. Center Forward, which claims to seek bipartisan, common ground on drug policy and other issues, received $300,000 directly from PhRMA and another $179,000 from a PhRMA-backed group called the Campaign for Medical Discovery, according to tax filings.

And the groups to which they donated were also pursuing narrower issues that supported the industry's economic interests, not broadly partisan (and in this case, prro-Democratic) issues. For example,

Center Forward worked to preserve a tax credit for researching rare-disease medicines known as orphan drugs. PhRMA took a similar stance, encouraging Congress “to maintain incentives” for rare-disease drugs.

The KHN article noted that there is evidence that individaul pharmaceutical companies hide their political advocacy, possibly mainly their advocacy of right-wing and/or Republican backed causes, in similar ways.

Johnson & Johnson gave $35,000 that year to the Republican Main Street Partnership, a 501(c)(4) that describes itself as a coalition of lawmakers committed to 'conservative, pragmatic government,' the C.P.A. data shows.

But the center’s research also shows that many pharmaceutical companies don’t disclose donations made to 501(c)(4) organizations, nor are they legally required to do so.

Corporations 'could dump millions into one of these (c)(4)s and nobody would ever know where it came from,' said Steven Billet, a former AT&T lobbyist who teaches political action committee management at George Washington University.

Summary and Discussion

So in three cases, health care corporations, and/or their trade associations, made significant financial contributions to dark money organizations, thus avoiding reporting of such fund transfers.  In two cases, these fund transfers went to organizations with clearly partisan, right-wing, pro-Republican and/or pro-Trump agendas.  Yet the corporations and their trade association had publicly committed themselves to social responsibility, putting patients and health care ahead of all other concerns, and had never advertised themselves as partisan, explicitly politically conservative, and/or Republican.

This is a new dimension of stealth health policy advocacy or stealth lobbying.  Most of the previous, at least pre-2016 campaign, examples we had found of these involved corporations promoting measures that would improve their revenue (and consequently their top managements' pay).  They did not involve explicitly siding with a single political party or political philosophy.

Patients, consumers, health care professionals, and the public at large might not be pleased but would probably not be too suprised that health care corporations and their management pursue financial self-interest, but prefer doing so without much publicity.  However, I suspect most people would be unpleanatly shocked to find out that well-known health care corporations have been actively siding with a single political party and that party's ostensible political philosophy, but keeping that support very quiet.

Since such dark money support is by definition secret, who knows how many health care organizations have been doing this?

As an aside, I wonder if this hidden support from large corporations has pushed one political party to more extreme actions despite such actions' popular disfavor?  But that is for more politically attuned people to ponder.

In any case, as we have said again and again,...

There are myriad ways corporate and political insiders push health policy agendas because of self-interest, regardless of their effects on patients' and the public's health.  Health policy in the US has become an insiders' game.  Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction. 

Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox.  We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

Financial Ties of the Members of the Tysbari Advisory Panel

The Boston Globe reported that a new law designed to "limit industry influence" on the US Food and Drug Administration (FDA) have not had much effect. The law requires disclosure of financial ties to relevant organizations by participants on the FDA's advisory panels, but allows the FDA to seek waivers to let those with such ties serve on these panels.

The news article focused on ties affecting an advisory panel that recommended that Tysbari, a drug for multiple sclerosis, made by Biogen Idec and Elan, be allowed back on the market. Five of 12 had relevant financial relationships. It quoted Dr Karl Kieburtz, the chairman, who is a consultant to Biogen Idec, "All behavior is guided by conscious and unconscious motives. Consciously, I'm not aware of of any swaying of my decision-making based on the fact I did consulting for Biogen Idec within the last year." Kieburtz noted that he received no more than $12,000 for consulting, which was not related to Tysbari or multiple sclerosis, and he gave the payments to his institution, the University of Rochester, or charity. Another member of the panel, Dr Steven DeKosky, "said he didn't know he had a conflict until he filled out the FDA's disclosure forms in which he had to list all the work he'd done recently for industry." DeKosky "disclosed he'd received less than $10,001 as an industry sponsored speaker and was paid less than $10,001 by Pfizer Inc. as a visiting professor. Until the FDA issued his waver, DeKoskey said he did not know that a rival MS drug is made by a company that has a financial agreement with Pfizer." The article also reported that "other Tysbari advisers reached by the Boston Globe who received FDA waivers said drug industry funding did not influence their votes."

The FDA's stance was that trying to get the most expert to serve on the panels requires recruiting "scientists with drug industry sponsorship. Barring those researchers would result in smaller panels with less expertise."

However, Merrill Goozner, director of th Integrity in Science Project for the Center for Science in the Public Interest, (and author of the blog, GoozNews), thinks that the FDA should issue no waivers, "Period. End of story. Get rid of scientists with conflicts from serving on the FDA advisory panels."

A while back we posted on an article in JAMA (Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.) that argued that practicing physicians should be barred from receiving even gifts of trivial value (the proverbial pen or coffee mug with the company logo on it) because

social science research demonstrates than the impulse to reciprocate for even small gifts is a powerful influence on people's behavior. Individuals receiving gifts are often unable to remain objective.

If there is concern that getting a coffee mug with a company logo might affect a practicing physician's decision making, there surely ought to be a concern that getting $10,000 for consulting, giving a talk, or being a visiting professor, even if that money ultimately goes to one's employer, may affect the decision-making of a member of an influential national committee. As both a recent NY Times op-ed, and the JAMA article argued, the effects of gifts or other payments may not be conscious, so the recipients may not honestly be conscious of their effects. (Dr Kieburtz seemed to acknowledge that possibility above.) Thus, that their recipients deny that the gifts had conscious effects is of little comfort.

Thus, if the goal is unbiased decision making, Merrill Goozner's "just say no" approach to panel members with conflicts of interest seems justified.

(Full disclosure: I own more than $10,000 worth of stock in Elan.)