Wednesday, September 29, 2010

That Wheel Was Already Invented: the UN Special Rapporteur's Guidelines for Pharmaceutical Companies

For five years now, we have been writing about concentration and abuse of power in health care, and on specific tactics used predominantly by large health care organizations that threaten the values that physicians and other health care professionals once swore to uphold.

Pharmaceutical companies may not have been the worst offenders when it came to threatening these values, but they have not been laggards.  Specific issues we have discussed included (in a peculiar order that I will explain in a minute): failure of the companies' boards of directors to be accountable for misbehavior by its management, sometimes associated with conflicts of interest affecting these board members (e.g., this recent case); outright crime and corruption (e.g., this case); use of key opinion leaders paid by the company to market products cloaked in the mantle of academia; payments made by the companies to patient advocacy groups (e.g., this one), medical societies, and academic institutions that induce institutional conflicts of interest, and enlist these well-reputed organizations as stealth marketers; ridiculously high prices charged for particular medicines, often to particularly vulnerable patients (e.g., this case); suppression and manipulation of clinical research evaluating the companies' products; and deceptive drug marketing practices.

Many other bloggers have written about these issues.  Some of them have been widely taken up in the mainstream media.  A few have even made it into the medical and health care literature. 

But those of us who bring them up have been attacked as a tiny group of pharmascolds (e.g., here), who get in the way of the needed innovation and scientific advances that the pharmaceutical industry generously brings to the public.  Despite such attacks, it may be that our concerns are somewhat more universal, although those with vested interests in maintaining the status quo might not want that publicized too much.

A new issue of PLoS Medicine included several articles on drug companies' responsibilities for human rights.  One was by a former United Nations Special Rapporteur on the right to the highest attainable standard of health.  I, and I suspect most of even our Health Care Renewal readers were not familiar with that office.  I also confess to being unaware that he had published a report to the UN General Assembly entitled Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, which included 47 specific guidelines. 

Amazingly enough, it turns out that some of these guidelines seemed to directly address the issues raised above, to wit:

Board of Directors' Accountability
11. The company should have a governance system that includes direct board level responsibility and accountability for its access to medicines policy.

15. A company should publicly adopt effective anti-corruption policies and measures, and comply with relevant national law implementing the United Nations Convention against Corruption.

Disclosure of Financial Support
18. The company should annually disclose its financial and other support to key opinion leaders, patient associations, political parties and candidates, trade associations, academic departments, research centres and others, through which it seeks to influence public policy and national, regional and international law and practice. The disclosure should extend to amounts, beneficiaries and channels by which the support is provided.

19. When providing any financial or other support, the company should require all recipients to publicly disclose such support on all appropriate occasions.

Drug Pricing
33. When formulating and implementing its access to medicines policy, the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible. In keeping with Guideline 5, the company should give particular attention to ensuring its medicines are accessible to disadvantaged individuals, communities and populations, including those living in poverty and the very poorest in all markets. The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and public private partnerships.

34. The arrangements should take into account a country’s stage of economic development, as well as the differential purchasing power of populations within a country. The same medicine, for example, may be priced and packaged differently for the private and public sectors within the same country.

35. The arrangements should extend to all medicines manufactured by the company, including those for non-communicable conditions, such as heart disease and diabetes.

Suppression and Manipulation of Clinical Research
39. The company should take effective measures to ensure that all information bearing upon the safety, efficacy and possible side effects of a medicine are easily accessible to individuals so they can make informed decisions about its possible use.

Deceptive Drug Marketing
41. The company should publicly disclose its promotional and marketing policies and activities, including costs.

Needless to say, I can see no evidence that any big pharmaceutical companies are trying to adhere to any of these guidelines.  Somehow I suspect that those who are supporting the vested interests of big pharmaceutical corporations may not all have that much respect for the United Nations.  However, I think that the Special Rapporteur's guidelines lend more credibility to the argument that we need better leadership of health care organizations, and specifically that such organizations should follow clear ethical precepts, and their leadership should be held accountable when they do not.

So the next time someone calls you a "pharmascold," you can say, "yeah, yeah, so is the UN Special Rapporteur."


Anonymous said...

The retort “prove it” is an old sales trick. Decades ago, in my oft mentioned class taught by the sales manager of a drug wholesaler, we were instructed that the role of the sales manager was to prevent the very actions we see being taken by the drug companies of today.

Placing a product in a good light is salesmanship, distortions are criminal.

I have been shocked at the resistance of doctors to admit that they are influenced by drug company sales practices. Pharmalot has a posting, The Shocking Truth About Free Lunches And Pens.

This covers the work by Dr. Fugh-Berman at Georgetown and the “proof” about the influence peddling that goes on in the drug industry. This was a subject covered in an undergraduate class decades ago and the “prove it” crowd has managed to hold off any review for a very long time.

What I have observed is that over time the limits imposed by management have been eliminated in a rush for short term profits. The vetting process for most upper management positions is the ability to be sleazy and deceptive.

None of these business practices will stop until responsibility is imposed by corporate boards, unlikely, or legal pressure from the outside.

The “prove it” hurdle will remain in place as long as it works. The only solution from my perspective is strong legal responses to these issues, including felony convictions.

Steve Lucas

JR Hoffman said...

This week's blog is outstanding, as usual, but I have one minor quibble. While it may be true that that corporations are often so arrogant, and feel so immune, that they refuse to do even this minimal damage control, I suspect we are misled when we consider the occasional "apology" to be remarkable -- rather than quite predictable.

Companies always claim "we're all about improving health" rather than "we're only about maximizing profit" -- b/c acknowledging the latter would mean they'd make less profit! In the same way, when their hand is caught in the cookie jar, it's simply good business for them to say "it was a mistake ... we're correcting it ... that type of problem is a thing of the past ..." (That's exactly what the bankers said about the melt-down, and the car-makers said about rollovers and about runaway brakes, and the government said about "oops, actually we were the ones who fired on them in the Gulf of Tonkin ... oops, actually there were no WMDs," or "it was a mistake ... we're correcting it ... that type of problem is a thing of the past ..." about My Lai / Abu Ghraib / the revelations in Pentagon Papers / the revelations of Wikileaks, ... -- for exactly the same reasons.)

Sometimes we get angry, thinking "the worst part is they (whether drug companies or bankers or politicians) are so hypocritical" -- but as understandable as that reaction is, it's actually important to recognize that this behavior is not hypocritical (nor surprising) at all -- but rather simply good PR = good business = inevitable!

That's b/c they know, all the while, that there just as there wasn't any real punishment for the crimes already committed, nor is there any reason whatever not to keep repeating the very profitable crimes ... along with the "apologies," as necessary, in the future.