Princess Health and Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices. Princessiccia

Princess Health and Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices. Princessiccia

anechoic effect deception health care corruption manipulating clinical research marketing pharmaceuticals suppression of medical research Transparency International

Gusty 07:28 Add Comment

Health Care Corruption as a Taboo Topic

Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report did not get much attention.  Since then, health care corruption has been nearly a taboo topic in the US.  When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries.  On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here).  But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries.  Health Care Renewal was practically the only source of coverage in the US of the survey's results.

Transparency International's New Report on Corruption in the Pharmaceutical Sector

Now Transparency International (TI) has tried, and Health Care Reenewal will try again.  In June, 2016 Transparency International published a new report entittled

Corruption in the Pharmaceutical Sector

The report's executive summary states:

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.

In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,

Manipulation of Clinical Research

We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients.  The TI report included: 

As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.

Suppression of Clinical Research

We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests.  The TI report included:

Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.

Manipulation of the Dissemination of Clinical Research

We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients.  For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:

The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.

Deceptive Marketing

We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm.  In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks.  The TI report included:

There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company�s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.

Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors� prescribing habits and encouraging off-label, unlicensed use to increase sales.

Other Topics

Finally, the report mentions such issues as the revolving door, regulatory capture, etc, etc, etc

A Striking, and Strikingly Anechoic Report

Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption.  That is a sentiment rarely heard in the US, and one that appears nearly taboo.  

Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries.  Let me note the important exceptions, however.

I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1)  The only substantial news article I could find on the report was also from the UK, in the Independent.  Its sub-title is worth repeating:

Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people

Also, there were brief articles in Reuters, and in (web-only) FiercePharma.  That is about it so far.

The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion.  Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the TI Report itself,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.


I might as well repeat myself once again.  As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

Reference

1.  Torjesen I.  Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.

Princess Health and Legislature's many health bills include some with life-saving potential, better prevention, greater access and help for children. Princessiccia

Princess Health and Legislature's many health bills include some with life-saving potential, better prevention, greater access and help for children. Princessiccia

assisted living autism cancer drugs General Assembly health care access influenza legislation legislature pharmaceuticals pharmacies pharmacists physician assistants smoking state government

Gusty 13:57 Add Comment

By Melissa Patrick
Kentucky Health News

One paragraph in this story was incorrect and has been stricken.

FRANKFORT, Ky. -- Kentucky legislators have all but ended their regular session without agreeing on a budget, but were able to pass a wide range of health bills that await Gov. Matt Bevin's signature or veto.

Legislators can still pass more bills, including a budget, when they return for one day, April 12, and reconsider any bills the governor vetoes (except the budget, if one passes that day).

Many of the health bills deal with regulation, such as which agency oversees home medical equipment and licensing rules for physicians. Others, like SB 211, sponsored by Sen. Alice Forgy Kerr, R-Lexington, establish a special day to encourage research for amytrophic lateral sclerosis by officially naming Feb. 21 "ALS Awareness Day."

But several others will impact the daily lives of Kentuckians, directly or indirectly. Some have the potential to save lives.

Senate Bill 33, sponsored by Sen. Max Wise, R-Campbellsville, requires every Kentucky high-school student to receive compression-only CPR training. "Each year nearly 424,000 people have sudden cardiac arrest outside of the hospital and only 10 percent of those victims survive," Wise said at a Jan. 13 Senate Health and Welfare Committee meeting. "Yet when a CPR trained bystander is near, they can double or triple these victims survival rate."

Another bill with life-saving potential would let Kentuckians take time off work to be "living donors" or donate bone marrow without the risk of losing jobs or income. House Bill 19, sponsored by Rep. Ron Crimm, R-Louisville, requires paid leave of absence for such reasons, and offsets this cost to the employer with tax credits.

(An amendment to this bill, illustrating how legislation gets passed in unusual ways during the closing days, would allow Lexington to impose an additional 2.5 percent hotel-room tax to improve its convention center.)

A minor housekeeping bill had an important health amendment attached to it that mandates assisted-living communities to provide residents with educational information about the flu by Sept 1 of each year. SB 22 is sponsored by Sen. Ralph Alvarado, R-Winchester. The CDC estimates that between 80 and 90 percent of seasonal flu-related deaths occur in people over 65.

Colon cancer, which kills more than 850 Kentuckians a year, remained in the spotlight with passage of HB115, sponsored by Rep. Tom Burch, D-Louisville. It would expand eligibility for screenings to age-eligible, under-insured Kentuckians, or uninsured persons deemed at high risk for the disease. This bill is aimed at the 7 percent of Kentuckians who have remained uninsured since the state expanded Medicaid under federal health reform, and those who have insurance but can't afford deductibles or co-payments.

Other bills intended to create better access to care for Kentuckians would expand the duties of advanced practice registered nurses (SB114); decrease the oversight of physician's assistants (SB154); create a pilot program to study telehealth and how it's paid for (HB 95); and better define who can perform administrative duties in pharmacies (HB 527).

Children: "Noah's Law," or SB 193, sponsored by Alvarado, mandates the coverage of amino-acid-based formulas for eosinophilic esophagitis and other digestive disorders. It will have an impact on more than 200 Kentucky families. It is called "Noah's Law" after 9-year-old Noah Greenhill of Pike County who suffers from the disease, which requires him to get this formula through a feeding tube four times a day because of severe food allergies, at a daily cost of more than $40. This bill has already been signed by the governor and took effect immediately.

HB148, sponsored by Rep. Linda Belcher, D-Shepherdsville, allows day-care centers to be able to obtain and store epinephrine auto-injectors for emergency use. This bill was amended to include "participating places of worship" as a location that newborns up to 30 days old can be left without threat of prosecution to the parent or family member who leaves them there.

The latest Centers for Disease Control and Prevention study found that one in 68 of the nation's children have autism, and Kentucky legislators passed two bills this session to address their needs. SB 185, sponsored by Sen. Julie Raque Adams, R-Louisville, creates the Office of Autism and guidelines for an Advisory Council on Autism Spectrum Disorders. This bill has already been signed by the governor. HB 100, sponsored by House Minority Leader Rep. Jeff Hoover, R-Jamestown, requires insurers to maintain a website to provide information for filing claims on autism coverage and make autism-benefit liaisons available to facilitate communications with policyholders.

Big bills: One of the high-profile health bills that passed this session is SB20, sponsored by Alvarado, which creates a third-party appeals process for providers to appeal denied Medicaid claims. Alvarado has said that 20 percent of Medicaid claims are denied, compared to the national average of around 6 percent. He suggest that bringing this bill will help bring these numbers more in line with each other and thus will encourage more providers to participate in Medicaid.

A bill that will eventually increase accessibility to drugs made from living tissues that are very expensive, but also very effective, also passed. SB 134, sponsored by Alvarado, would allow pharmacists to substitute a less-expensive "interchangeable biosimilar" drug for its name-brand "biologic" one, even though the U.S. Food and Drug Administration hasn't approved these interchangeables yet. Humira and Remicade for arthritis, and Enbrel for psoriasis, are a few of the most common biologics on the market.

Another bill is aimed to help small-town pharmacies stay competitive with chains. SB 117, sponsored by Wise, allows the state Insurance Department to regulate pharmacy benefit managers, like Express Scripts, much like insurance companies. It would also provide an appeal mechanism to resolve pricing disputes between pharmacies and PBMs. The state has more than 500 independent pharmacists that will be affected by this law.

Bigger issues: Health officials say the single most important thing that Kentucky can do to improve the state's health at no cost is to pass a statewide smoking ban for workplaces. Rep. Susan Westrom, D-Lexington, filed a smoke-free bill late in the session that didn't even get a hearing in committee, despite having passed the House last year. Bevin opposes a statewide ban.

Adams and Alvarado filed a bill to require insurance companies to pay for all evidence-based smoking cessation treatments in hopes of decreasing the state's smoking rate, but it was filed late in the session and only brought up for discussion.

Democratic Rep. David Watkins, a retired physician from Henderson, filed three bills to decrease smoking in the state: one to increase the cigarette tax, one to raise the legal age for buying tobacco products to to 21, and one to require retail outlets to conceal tobacco products until a customer requests them. All were to no avail.

Rep. Darryl Owens, D-Louisville, filed bills to continue the Kynect health-insurance exchange and the state's current expansion of the federal-state Medicaid program. The bills passed mostly among party lines in the House, but the Senate has not voted on them as Senate President Robert Stivers said he would if the House did.

Princess Health and Adults 62-85 are often taking combinations of drug or dietary supplements that could be deadly; risk nearly doubled in 5 years. Princessiccia

Princess Health and Adults 62-85 are often taking combinations of drug or dietary supplements that could be deadly; risk nearly doubled in 5 years. Princessiccia

alternative medicine generic drugs over-the-counter medicine pharmaceuticals prescription drugs research

Gusty 06:53 Add Comment

Update: 4/4/16, This story has been updated to reflect that the study says the number of adults using at least five prescription drugs a day has increased and not the average older American is using at least five prescription drugs a day.

The number of older Americans at risk of potentially life-threatening drug interactions almost doubled between 2005 and 2011, according to a study from the University of Illinois at Chicago.

"One in six older adults now regularly use potentially deadly combinations of prescription and over-the-counter medications and dietary supplements, a two-fold increase over a five year period," says the release.

More than half the potentially deadly interactions involved a non-prescription medication or dietary supplement such as a vitamin. The study found that older adults have increased their use of vitamins and supplements, despite limited evidence of their clinical benefit.

The study, published in JAMA Internal Medicine, examined changes in medication use in more than 2,000 adults aged 62 to 85 between 2005 and 2011.

Fifteen potentially life-threatening drug combinations of the most commonly used medications and supplements were identified, and the study found nearly 15 percent of older adults in 2011 used at least one of these dangerous combinations, up from 8 percent in 2005.

The study found that older adults have grown more fond of non-prescription medications and supplements: 63.7 percent of older adults used them in 2011, up from 51.8 percent in 2005. Older adults using at least five prescription medications increased to 35.8 percent from 30.6 percent in the same time period.

The most common life-threatening interaction identified by the study was cholesterol-lowering drugs (statins), drugs used to prevent blood clots (anti-platelet drugs) and omega-3 fish oil supplements.

�Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,� one of the researchers said in a news release.

The researchers encourage health-care providers to carefully consider adverse effects of combining prescription and nonprescription medications when treating older adults, and to counsel patients about the risks. Older adults should also ask their pharmacists about potential drug interactions.

Princess Health and Customers of exchanges such as Kynect are more likely to get prescriptions than other private health-insurance customers. Princessiccia

Princess Health and Customers of exchanges such as Kynect are more likely to get prescriptions than other private health-insurance customers. Princessiccia

drugs health insurance insurance exchange obamacare Patient Protection and Affordable Care Act pharmaceuticals prescription drugs

Gusty 04:22 Add Comment

"People enrolled in health plans through the Affordable Care Act exchanges are ramping up their use of prescription medications more rapidly than those in employer or government-sponsored plans, according to a new report from Express Scripts, the largest prescription drug benefits company," Carolyn Y. Johnson reports for The Washington Post, which headlined the story "A new sign Obamacare is helping the people who really need it."

"In 2015, people in the exchanges increased their number of prescriptions filled by 8.6 percent, four times the rate of people who receive insurance through commercial plans outside of the exchanges," Johnson writes. However, "The overall amount spent was much lower per person -- $777.27 compared to $1060.75" for commercial plans.

"The rapid uptake of the prescription drug benefit suggests there was a significant unmet medical need for many people gaining insurance through the exchanges, some of whom could have preexisting conditions and may not have previously had access to medicines," Johnson reports. "Before 2014, insurance companies could refuse coverage or charge much higher premiums for people with pre-existing conditions."

Express Scripts handles about a third of the prescriptions paid for by plans sold through the exchanges, including Kynect in Kentucky.

Princess Health and The US' Multinational Trade Negotiations - Trading Away Its Own and Other Countries' Current and Future Restraints on Drug Prices?. Princessiccia

Princess Health and The US' Multinational Trade Negotiations - Trading Away Its Own and Other Countries' Current and Future Restraints on Drug Prices?. Princessiccia

CMS health care prices Medicare pharmaceuticals regulatory capture revolving doors trade policy US Trade Representative

Gusty 11:48 Add Comment

Trade Agreements More about Deregulation than Trade

International trade negotiations, especially their more technical aspects, seem far removed from health care and health policy, and unrelated to health care dysfunction.  However, it seems that such trade negotiations have become a back door route to affect health policy, especially national efforts to regulate health care intended to improve patients' and the public's health.  

We recently discussed how current multinational trade negotiations seem to be more about changing regulation in favor of big corporations than broadly advancing trade.  Some of the effects of the proposed trade pacts could have bad effects on patients' and the public's health, particularly by allowing corporations to challenge particular countries' public health policies outside of these countries' judicial systems, in kangarooish courts seemingly designed to favor corporate interests.  Also, the trade pacts' focus on intellectual property could lead to longer patent protection on drugs, biologics, and devices, raising health care costs.  However, attempts to figure out how proposed trade agreements could affect health care and public health were hindered by the secrecy surrounding the negotiations.

"Procedural Fairness" for Pharmaceutical Companies, not You and Me

Earlier in June, 2015, a part of the current draft of the Trans-Pacific Partnership (TPP) appeared on  Wikileaks, revealing yet another set of concerns about how the agreement could affect health care.  It was entitled "Annex on Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices," and hence was specifically about health care.

The bulk of the annex seemed to be about improving the treatment of drug, device and biotechnology companies by national agencies that make decisions about payments for their products. The annex apparently proposed establishing the companies' rights to rapid reviews, access to applicable procedures and guidelines, access to written decisions, company appeals of the agencies' decisions, and protection of corporate confidential information. On the other hand, there was nothing I could see in the annex about the rights of, say, patients or health care professionals.

We have noted the concern that international trade agreements may make government regulation subject to corporate appeal in "investor-state dispute settlement" (ISDS) processes, essentially international quasi-courts that are not subject to national judicial systems, may not provide for any input by parties other than governments and corporations (that is, by, for example citizens, patients or health professionals), and may not allow appeal.  Thus, by specifically incorporating new protections for corporations seeking favorable payments for their new products from national agencies, the annex could make it possible for the corporations to appeal to ISDS, going around national court systems.  As reported in the Huffington Post,

According to an analysis of the leaked document by Jane Kelsey, a law professor at the University of Auckland in New Zealand, these rules are enough to expose national health authorities to legal challenges under TPP�s investor-state dispute settlement process, or ISDS. ISDS empowers companies to challenge countries� domestic laws before a tribunal of international judges if they believe the laws unfairly limit investment. The tribunals have the power to impose significant fines on countries if their laws are found responsible for the investment hardship in question. While pharmaceutical companies could not challenge national health programs� policies through ISDS, their grievances would be eligible for ISDS if the companies claimed the policies hindered investment.

In fact, the Huffington Post article noted suspicions that the US Trade Representative (USTR) has been negotiating on behalf of big US drug, device and biotechnology companies to target price regulations in Australia and New Zealand,

Among the United States� TPP negotiating partners, pharmaceutical provisions have faced the greatest opposition from Australia and New Zealand, which have national health authorities that provide prescription drugs to their citizens at heavily discounted rates. The U.S. Trade Representative and U.S. pharmaceutical companies have targeted the cost containment measures in those countries� prescription drug programs for years. Pharmaceutical companies also claim that New Zealand�s drug approval process is opaque and difficult to navigate.

Why Explicitly Include the US Center for Medicare and Medicaid Services (CMS)?

However, anyone in the US who thinks that all the burden from the trade pact is only on other countries, particularly those down under, should think again. The draft trade pact annex also seemed designed to prevent any future attempts by the US government to control drug and device costs, especially for the US Medicare program, even though the current US President has proposed such attempts. 

Note that when the US program was extended to cover drugs, the legislation specifically forbade the government from negotiating prices, a provision that seemed more about protecting corporate revenues than the federal budget.  So, as reported by the New York Times,

The newly leaked annex, dated Dec. 17, 2014, lists Medicare and the Centers for Medicare and Medicaid Services as falling under its strictures.

The USTR pooh poohed any concerns about that,

Officials at the United States trade representative�s office, while declining to comment on a leak they would not acknowledge, said rules in the Pacific accord would have no impact on the United States because Medicare already adhered to them. The trade representative�s office helped develop the proposals.

'Already, transparency and procedural fairness are integral parts of the U.S. legal system and as such are principles reflected in U.S. trade agreements,' the representative�s office said in a statement.

Maybe preventing any government negotiation about, much less control of drug and device prices may be part of what the USTR called "procedural fairness."  In any case, if the US, and specifically CMS are doing so well, why bother giving this trade pact jurisdiction over them, unless to prevent any uppity future US government from daring to negotiate with the pharmaceutical industry?

The Huffington Post noted that

In an earlier statement, [Director of Public Citizen's Global Access to Medicine Project Peter]  Maybarduk expressed concern that the rules would 'limit Congress� ability to enact policy reforms that would reduce prescription drug costs for Americans �- and might even open to challenge aspects of our health care system today.'

He expanded on that in a commentary for The Hill,

Earlier this week, WikiLeaks published the draft TPP 'Annex' on healthcare technologies. In the five-page document, the U.S. government commits Medicare to rules and procedures that would make it difficult � if not impossible � to implement a national formulary that would provide leverage for proposed negotiations with drugmakers under Medicare Part D.

Medicare costs are expected to more than double from $77 billion in 2015 to about $174 billion in the next decade. In February, the president called for giving Medicare the power to negotiate prices with drug manufacturers to ameliorate this cost burden. Americans support giving Medicare negotiating power by wide margins and across party lines.

Negotiations are most effective if the U.S. government has leverage. Experts suggest that key leverage in Medicare negotiations should come from developing a national drug formulary � a list of drugs that Medicare would cover. A formulary would stimulate competition, reduce prices and lead to healthier outcomes for patients and the healthcare system.

But the leaked TPP 'Annex' shows that the pact would impose procedural requirements on formulary decisions, exact significant administrative costs and open up the drug review process to increased corporate influence. Medicare would have to live by these rules. The result could be a toothless negotiator, and a formulary filled with expensive drugs that have questionable public health benefits, if any.

Summary

So why did the US Trade Representative acquiesce to, if not actively promote, a trade pact that would limit the ability of the US government, specifically, CMS to try to put a damper on the ever rising health care prices that threaten to bankrupt individuals and maybe eventually the Medicare program itself? And why, incidentally did it do so when this appeared to contradict the current US President's own stated goal to have Medicare negotiate the prices it pays for drugs?  (And why, incidentally, did it promote a pact that would give international tribunals jurisdiction over US government actions when that may be unconstitutional according to an increasing number of experts?) 

The best speculation we offered before was that the USTR has been "captured" by industry, in part through the conflicts of interest generated by multiple passages through the revolving door by current and former USTR personnel. 

At the moment, the TPP has stalled again in the US Congress.  However, do not underestimate the ability of its proponents to get it moving again.  The now intermittent drip of secrets from the ongoing trade negotiations showing how little they have to do with trade, and how much they have to do with advancing corporate interests suggest the need for much more vigilance in defense of patients' and the public's health.

Meanwhile, I repeat again that we need to do a lot more to undo regulatory capture that affects health care, and stop the incessantly spinning revolving door.    Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

Princess Health and Louisville's PharMerica is still a defendant in federal cases in which big drug makers have paid billions in fines.Princessiccia

Princess Health and Louisville's PharMerica is still a defendant in federal cases in which big drug makers have paid billions in fines.Princessiccia

drug companies drugs journalism law enforcement nursing homes pharmaceuticals pharmacies

Gusty 16:35 Add Comment

Abbott Laboratories has paid billions, and Amgen Inc. has paid millions, in fines for offering "rebates" or "kickbacks" to get pharmacy companies to increase their prescriptions of drugs in nursing homes, and PharMerica Corp. of Louisville is the remaining defendant in both civil cases, according to a detailed report by James McNair at the Kentucky Center for Investigative Reporting.

PharMerica manages drug benefits for nursing homes, hospitals and assisted living facilities. McNair paints a dismal picture of nursing homes and says they are ripe for this type of abuse, writing that they house "people with age-weakened bodies, multiple ailments and, often, severe mental impairment. Many are over-medicated. Many have no visitors. A third of them will die within a year of admission." (Click on chart for larger version)

McNair notes that a whistleblower lawsuit first called attention to Abbott Labs, which pled guilty in 2012 to a criminal charge, settled civil kickback and fraud claims, and paid $1.5 billion in fines for its role in paying millions of dollars in "rebates" to get pharmacy companies to increase prescriptions for an anti-seizure drug, Depakote, for uses beyond its Food and Drug Administration approval. Medicaid payments for this drug "went on to top $7 billion," McNair reports.

Amgen also enlisted these same pharmacy companies to promote its anemia drug, Aranesp, for uses beyond its FDA approval, and after pleading guilty settled civil kickback and fraud charges and paid a total of $762 million in fines.

These two cases brought more government attention to such schemes, which are "standard practice in the pharmaceutical industry," and also on the pharmacy companies that are on the receiving end of the payoffs, McNair writes.

McNair describes PharMerica as the "second-biggest operator of nursing home pharmacies in the country" and writes that it had " $1.9 billion in revenue last year," making it the "10th-biggest publicly traded company in Kentucky, according to rankings by The Lane Report." Since 2007, the chief executive has been Gregory Weishar (pronounced WISH-er) .

Companies like PharMerica, and its larger competitor Cincinnati-based Omnicare Inc., act on behalf of the nursing homes, buying drugs from the pharmaceutical companies in bulk and then dispensing them under the supervision of "consultant pharmacisits," McNair reports.

The Abbott Labs and Amgen lawsuits assert that PharMerica gave "certain drugs to nursing home patients in return for drug company kickbacks, not because they were the "right medication."" McNair reports that the suits were filed by drug company insiders who have knowledge of these payoffs disguised as "rebates" or "discounts."

"PharMerica denies the claims," writes McNair. But the company has been in this type of case many times since 2005, McNair reports: It has agreed to pay $40 million in fines to settle federal complaints, five additional closed cases connected to this company.

McNair also reports that just last week, the Justice Department said PharMerica will pay $31.5 million for dispensing addictive painkillers to nursing home patients without prescriptions, then falsely billing Medicare. As part of this settlement, PharMerica also agreed to a five year "corporate integrity agreement," which McNair notes later in the article are rarely enforced.

McNair goes on to list the details of several other cases PharMerica has been involved in, one of them "deemed so flagrant that the inspector general sought to ban PharMerica from federal health-care programs for 10 years."

PharMerica declined to make its executives available for an interview with the Kentucky Center for Investigative Reporting but said in a statement: �PharMerica is committed to outstanding compliance and the highest standards of ethical conduct, and we are diligent in ensuring that we comply with all applicable law and regulation,�

Jan Scherrer, vice president of Kentuckians for Nursing Home Reform, a non-profit advocacy group based in Lexington, told McNair that the CEOs of companies involved in kickback schemes should be held personally accountable, "These are not victimless crimes," he said.

�It�s the same players -- PharMerica and Omnicare,� Scherrer continued. �They keep doing this over and over and over, and all they get is a fine. And for them that fine is nothing more than the cost of doing business.� (Read more of this detailed report by clicking here.)

Princess Health and . Princessiccia

Princess Health and . Princessiccia

academic corruption conflict of interest evidence-based medicine institutional conflicts of interest NEJM pharmaceuticals physicians

Gusty 13:59 Add Comment

Why is the New England Journal of Medicine Scolding "Pharmascolds"?

I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.

Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias � The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions.  Why?  Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine.  Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.

Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science.  In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement. 

Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?

Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing."  Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally."  True.  But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.

Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong. 

I beg to differ.  For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict.  It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility. 

Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts. 

In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck."  Heck, let's get rid of traffic lights too, while we're at it.  People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.

In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible?  One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.

Conflicts of interest should be avoided.  Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs). 

Wally R. Smith, MD

Princess Health and BLOGSCAN - New England Journal of Medicine Scoffs at "Pharmascolds" . Princessiccia

Princess Health and BLOGSCAN - New England Journal of Medicine Scoffs at "Pharmascolds" . Princessiccia

conflicts of interest New England Journal of Medicine pharmaceuticals

Gusty 09:18 Add Comment

The venerable New England Journal of Medicine has now published an editorial,(1) and two commentaries(2-3), with one more promised, hailing physician industry "partnership," as per NEJM editor Jeffrey Drazen,(1) and deploring the "pharmascolds,"(3) who might question the glorious innovations that could arise when industry pays academic and practicing physicians.   

In a tweet, Dr Harlan Krumholz said he was "shocked" that a NEJM commentary would "give credence to the 'pharmascold' narrative.  

So far, the only more detailed questions about this new direction for the Journal came in a guest blog by Dr Susan Molchan in the HealthNewsReview blog, which responded only to the editorial(1) and the first commentary(2).  Dr Molchan wrote, 

Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs. She asks, �Have stories about industry greed so permeated our collective consciousness that we have forgotten that industry and physicians often share a mission � to fight disease?� Is Dr. Rosenbaum�s consciousness so clouded as to think that pharmaceutical companies don�t exist first and foremost to make money? That their primary responsibility is not to their shareholders?  It�s true that a means to this end is fighting disease, (including new �diseases,� tailored to one�s drug), but this should not be confused or conflated with the primary mission of (hopefully most) physicians.

I and many others suggest that the 'stories about industry greed' have not permeated enough, and that this problem has polluted much of medical research and medical practice, to the point where trust of the medical research enterprise has been eroded....

The airtime the NEJM is giving this issue, including publishing three - count them - strongly opinionated but hardly journalistic commentaries by their ostensible"national correspondent," suggest a major push against the "pharmascolds."  Again, note this this inflammatory and ad hominem term was used in a supposedly serious article on "Medicine and Society."  I strongly doubt we have heard the last of this.  Stay tuned. 

ADDENDUM (20 May, 2015) - See also comments by Mickey on the 1BoringOldMan blog.  

References
1.  Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854.  Link here.
2.  Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015;  372:1860-1864.  Link here. 
3.  Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here. 

Princess Health and Innovations form the Safra Center Ending iCorruption Conference. Princessiccia

Princess Health and Innovations form the Safra Center Ending iCorruption Conference. Princessiccia

conflicts of interest health care corruption hospital systems pharmaceuticals regulatory capture

Gusty 12:23 Add Comment

I had the pleasure of attending the Ending iCorruption Conference, the capstone conference for the Edmond J Safra Research Lab on Institutional Corruption, held at the Harvard Law School on May 1-2, 2015.  The conference included much material relevant to health care corruption and related topics, and provided some innovative approaches that could be used to address these issues.  I list these below, with citations or links when available.  At some point in the future, all conference proceedings should be available on video from the Safra Center.

Uncovering Data on Conflicts of Interest

Unearth: Using PubMed to Uncover Conflicts of Interest Affecting Clinical Research

Unearth is a browser extension now available for Google Chrome, and soon to become available for other browsers, e.g., Firefox.  It works on PubMed searches, scraping funding and conflict of interest data from the body of articles and adding them to abstracts.  We have often discussed such conflicts of interest, and their relationship to manipulation of clinical research.  Unearth could make such conflicts more salient, making it easier to discriminate unconflicted from conflicted research.  (See this post on the Bill of Health blog.)  This application was developed during the Safra Center Hacking iCorruption Event.

Open Think Tanks: Uncovering Think Tank Funding

Think tanks often publish findings on and make recommendations about health care.  However, think tanks are often opaque, and any institutional conflicts of interest they have may not be easily apparent.  Open Think Tanks currently shows donations from government entities outside the US to US based think tanks.  Enhancements to include various kinds of private donations are likely in the future. This application was also developed during the Hacking iCorruption Event.

Finding Unconflicted Academics

As we have discussed, the majority of medical academics have conflicts of interest, which may affect their research, teaching and patient care.  Yet these conflicts are not always disclosed.  Furthermore, finding experts without conflicts is not easy.  ProfessorCert is a website that allows academics who have no conflicts of interest to register as such.  The website was developed by the Academic Independence Project. 

Improving Integrity

Putting Consumers in the FDA and Other Regulatory Agencies

We have frequently discussed regulatory capture, how government health care regulatory agencies, like the US Food and Drug Administration (FDA),  often seem to end up more concerned about the financial health of those they are supposed to regulate than patients' and the public's health.   Harvard Prof Daniel Carpenter, collaborator in Safra Center research,  talked about the problem of  "cultural capture" of regulatory agencies, in which the regulators' thinking is influenced by outside vested interests.  He proposed that regulatory agencies need to put consumers, or presumably other stakeholders like unconflicted health care professionals, "into the room."  

Putting Ethicists in the C- Suite

We have frequently criticized the leadership of hospitals and hospital systems.  In particular, we have discussed instances in which these leaders seem to have gone directly against the mission of their own organizations, which we termed mission hostile management. Safra Lab Network Fellow James Corbett, now Senior Vice President for Centura Health, proposed that ethicists who also understand the language of finance and management be present among the top leadership of hospital systems.  

Licensing Executives

As noted above, a major theme of the Health Care Renewal blog is the shortcomings of the leadership of large health care organizations.  Top leaders often have business training, but may be ill-informed about health care, and ignorant or unsupportive of  or even hostile to its values.  Wellesley College Professor Emerita Ann Congleton's 2014 article in the Journal of Business Ethics, entitled Beyond business ethics: an agenda for the trustworthy teachers and practitioners of business, proposed requiring that corporate executives, including executives of health care corporations, be licensed in order to lead their organizations.  I proposed licensing of leaders of large health care organizations as early as 2008 (here).    

Pharmaceutical Research Uninfluenced by the Pharmaceutical Industry

Because clinical research meant to evaluate drugs or devices sponsored by  manufacturers of the relevant products has shown to be frequently manipulated, or even suppressed, many people have suggested banning such sponsorship and direct influence of such manufacturers.  (For example, see the book and blog, both entitled "Hooked," written by Dr Howard Brody, and see Health Care Renewal blog posts, e.g., here.)
Safra Center Network Fellow and Rowan University Professor Donald Light's book in press, Good Pharma, basically offers proof of the concept that high quality clinical research on pharmaceuticals can be accomplished without industry money or influence, albeit in Italy, at the Mario Negri Institute. 

Summary

The project on institutional corruption at the Safra Center produced a burst of innovation meant to address this pervasive project, and thus provided much of value to those who want to challenge health care corruption.  I hope this innovation will turn out to be truly disruptive.  It is regretful that this project has come to an end.  We can only hope others pick up the banner.  

Princess Health andPain and fever reducer acetaminophen, most-used drug in U.S., is found to reduce positive emotions and reduce psychological pain.Princessiccia

Princess Health andPain and fever reducer acetaminophen, most-used drug in U.S., is found to reduce positive emotions and reduce psychological pain.Princessiccia

behavioral health drugs mental health pain pain management pharmaceuticals research

Gusty 19:56 Add Comment

Ohio State University researchers discovered a new side effect of acetaminophen, a leading over-the-counter pain reliever: it also blunts positive emotions. Other research revealed that it helps reduce psychological pain. The drug has been used in the U.S. for more than 70 years and is best known by the brand name Tylenol.

In the Ohio study, participants took Tylenol or a placebo, then looked at very pleasant or very disturbing photos. Those in the experimental group reported weaker emotions than those in the control group. On average, those who took the placebo rated their level of emotion when viewing the photos at 6.76 on a scale of 10, while people who took the pain reliever averaged 5.85.

"Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever," said Geoffrey Durso, the lead author of the study and a doctoral student in social psychology.

Balwin Way, an assistant psychology professor who conducted the study with Durso, said those who took Tylenol didn't seem to be aware they were reacting differently. "Most people probably aren't aware of how their emotions may be impacted when they take acetaminophen," he said.

Acetaminophen, found in more than 600 medicines, is the most common drug in the U.S., according to the Consumer Healthcare Products Association. Every week approximately 52 million American adults, 23 percent of the population, use a medicine with acetaminophen in it. Durso said researchers don't know if other pain relievers like ibuprofen and aspirin have similar effects, but they plan to study that question.

Princess Health and Princess Health andKentucky gets $1.75 million in national settlement with big drug maker; marketing and promotional practices reined in.Princessiccia

Princess Health and Princess Health andKentucky gets $1.75 million in national settlement with big drug maker; marketing and promotional practices reined in.Princessiccia

asthma depression drugs pharmaceuticals

Gusty 21:16 Add Comment

Kentucky will receive approximately $1.75 million from a $105 million national settlement with GlaxoSmithKline to resolve allegations that the pharmaceutical manufacturer unlawfully promoted its asthma drug, Advair, and its antidepressant drugs, Paxil and Wellbutrin, according to a press release from Attorney General Jack Conway's office.

The complaint and consent judgment alleges that GSK violated state consumer-protection laws by misrepresenting the uses and qualities of these drugs. Conway said in the release that this settlement will change the way pharmaceutical sales teams are motivated and paid.

The consent judgement requires GSK to reform its marketing and promotional practices, stating the company shall not: make any false, misleading or deceptive claim about its products; make claims not approved by the U.S. Food and Drug Administration; present information or conclusions from inadequate clinical studies; provide samples to health care professionals if they know it is being prescribed for non-approved use; or provide information describing any off-label use of a GSK product, unless consistent with applicable Food and Drug Administration regulations.

They must also continue a program through March 2019 that decreases financial incentives for sales representatives who use deceptive marketing practices, says the release.  In addition, scientifically trained personnel will be responsible for providing unbiased and non-promotional information to health care providers.

Kentucky joined 43 other states and the District of Columbia in reaching the national settlement with GSK.

Princess Health and Princess Health andBreakthrough drugs for targeted diseases work wonders, but are very expensive; some see a trend to worry about.Princessiccia

Princess Health and Princess Health andBreakthrough drugs for targeted diseases work wonders, but are very expensive; some see a trend to worry about.Princessiccia

cancer lung cancer pharmaceuticals research skin cancer

Gusty 17:03 Add Comment

Drugs focusing on narrow subsets of broader diseases are now being developed for individuals with specific genetic makeups. This trend prompts questions about who covers the cost, who gets the drugs and which diseases get the investment dollars, Brady Dennis reports for The Washington Post.

The newest "breakthrough" pharmaceutical is a new lung cancer drug named Zykadia, Dennis reports. The Food and Drug Administration released it four months ahead of schedule.

This drug is not designed to treat everyone who has lung cancer, which kills an estimated 160,000 Americans each year, including 3,500 Kentuckians. Kentucky's lung cancer death rate is almost 50 percent higher than the U.S. rate, placing Kentucky first in the nation for new cases and deaths from lung cancer.

Zykadia is designed to treat only about 5 percent of patients who fit into a specific subset of the disease: those who have advanced, non-small-cell lung cancer, and a specific gene mutation that causes tumors to resist other treatment, Dennis writes. For them�and only them�the drug has the proven potential to shrink tumors and extend lives.

�It�s a new world,� Wendy Selig, president of the Melanoma Research Alliance, told Dennis. �We�re segmenting what we thought of as large diseases into smaller populations of patients that are defined by genetic distinctions. .?.?. The goal is to match the right therapy to the right patient and to do it with minimal collateral damage.�

Since 2011, the FDA has approved numerous new treatments for melanoma, or skin-cancer patients with certain types of genetic mutations, specific cancers and a small proportion of people with cystic fibrosis, Dennis notes.

The FDA told Dennis that almost 40 of the nearly 50 drugs it has designated as potential �breakthroughs� involve targeted therapies. These targeted therapies often offer recipients earlier and better diagnoses, more effective treatments and even possible cures�or at least more time�for people who previously had little hope.

"But the trend toward targeted medicine also is forcing hard questions on regulators, drug makers, insurers and patients alike: Who should pay for the growing number of specialized drugs, which can cost hundreds of thousands of dollars a year? How does society ensure that everyone who might benefit�rich or poor�can receive treatment? What about patients whose specific conditions or mutations have not attracted investment dollars or the attention of researchers, leaving them to watch and hope from the sidelines?" Dennis writes.

Private insurers and Medicare generally cover the high drug costs, which currently account for only a fraction of overall health-care spending, Dennis reports.

But Barry Werth, an author and journalist who has spent decades writing about the pharmaceutical industry, asks, "What happens when targeted drugs become the rule rather than the exception? Will insurers refuse to cover some of them? Will the government ponder rationing them? Will only the wealthy be able to afford the best and newest treatments?"

This scenario could be happening with Sovaldi, a "groundbreaking new treatment" for the estimated 3 million Americans infected with hepatitis C, Dennis reports. Insurers are publicly rebelling against the drug's price of $1,000 per pill, or $84,000 for a 12-week treatment.

"The worry is that Sovaldi is the poster child for a �tsunami of expensive medicines� that collectively threaten to bankrupt the health-care system," John Rother, president of the National Coalition on Health Care, which represents insurers, employers, consumer and religious groups, health-care providers and some drug manufacturers, told Dennis.

�We�ve been able to absorb it so far because there are very few of them and because they are consumed by very small numbers of people,� Rother said of specialty drugs. �[But] if they�re all priced at the same level Sovaldi is, we really won�t be able to absorb it in the current system. It�s not sustainable.�

Edward Abrahams, president of the Personalized Medicine Coalition, an advocacy organization that includes drug makers, medical providers and patient and research groups, told Dennis that the cost of creating targeted drugs cost billions of dollars and often takes a decade or more to develop. Without the ability to recoup those costs, he said, "research will wither."

�As a society, we�re schizophrenic about this,� Abrahams told Dennis, adding that everyone wants to cure cancer and other diseases. �But at the other end, you have to be willing to pay for these products. .?.?. When you develop a drug for a segmented population, the cost of that drug is likely to be higher than if it worked for everybody.�

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Congress lobbying lobbyists pharmaceuticals politics

Gusty 10:40 Add Comment

Senate Republican Leader Mitch McConnell of Kentucky, whose public statements usually emphasize the need to cut federal spending on entitlement programs, as they did in Lexington Friday, apparently passed up an opportunity to rein in Medicare spending when he signed off on a big favor for a significant campaign contributor in the fiscal-cliff deal.

The deal delayed for two years price controls on a class of drugs including Sensipar, used by kidney-dialysis patients and manufactured by Amgen, "the world's largest biotechnology firm," Eric Lipton and Kevin Sack of The New York Times reported Jan. 19.

"The news was so welcome that the company�s chief executive quickly relayed it to investment analysts," the Times reported. "But it is projected to cost Medicare up to $500 million over that period. Dennis J. Cotter, who studies the cost and efficacy of dialysis drugs, told the newspaper, �Everybody is carving out their own turf and getting it protected, and we pass the bill on to the taxpayer.�

McConnell spokesman Robert Steurer said the senator did not push for the provision. The Times story did not focus on McConnell, saying "Supporters of the delay, primarily leaders of the Senate Finance Committee who have long benefited from Amgen�s political largess, said it was necessary to allow regulators to prepare properly for the pricing change." And it noted the firm "also has worked hard to build close ties with the Obama administration." It did note that former McConnell chief of staff Hunter Bates is among "a small army of 74 lobbyists for Amgen, which was "the only company to argue aggressively for the delay, according to several Congressional aides of both parties."

According to the Center for Responsive Politics, which analyzes lobbying and campaign contributions, Amgen's political action committee gave McConnell $7,000 during the 2011-12 election cycle, an amount exceeded by only seven other senators, none of them in the Senate leadership. McConnell was the main negotiator on the fiscal-cliff deal with Vice President Biden.

UPDATE, Jan. 25: Writing on BillMoyers.com and then on Salon, Bill Moyers and Michael Winship report that since 2007, "Amgen employees and its political action committee have contributed $73,000 to Senator McConnell�s campaigns," almost $68,000 to Sen. Max Baucus, D-Mont., chairman of the Finance Committee, and $59,000 to Sen. Orrin Hatch, R-Utah. They also note that Republican Rep. Richard Hanna R-N.Y., and Democratic Reps. Peter Welch of Vermont and Jim Cooper of Tennessee have introduced a bill "to repeal the half billion-dollar giveaway to Amgen. The story includes Moyers' video interview with Welch.

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

Princess Health and Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns.Princessiccia

advertising allergies drug abuse drug companies drugs legislation legislature meth methamphetamine pharmaceuticals pharmacies pharmacists pseudoephedrine state government

Gusty 05:14 Add Comment

Makers of over-the-counter drugs spent more than any lobbying interest ever had during a single Kentucky legislative session in their effort to defeat a bill requiring prescriptions for the key ingredient in methamphetamine, Bill Estep reports for the Lexington Herald-Leader.

"The Consumer Healthcare Products Association spent $457,053 on lobbying activities in the first three months of this year's legislative session, according to reports filed with the state Legislative Ethics Commission," Estep writes. "The group's lobbying effort was so dominant that it spent more than the next five groups combined in that period, January through March, according to spending reports."

And the figure doesn't even included hundreds of thousands of dollars that the trade group spent on radio and newspaper campaigns, because the lobby-reporting requirements do not apply to messages aimed only at the general public. The group did report spending on "a phone-bank operation to put people in contact with legislators to voice concerns about legislation to require a prescription for medicine containing pseudoephedrine, which is now available over the counter," Estep writes.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

The efforts, dating back to 2010, were partly successful. The legislature passed a bill "that will require a doctor's prescription for pseudoephedrine, but only after someone has bought 24 grams of the medicine a year," Estep notes. "A 48-count box of the generic medicine with 30-milligram pills contains 1.44 grams of pseudoephedrine. The bill excludes limits on gel caps and liquid pseudoephedrine." (Read more)

The lobbying effort wasn't only about Kentucky. The makers of Sudafed and other pseudoephedrine preparations are trying to stave off similar efforts in other states, and viewed Kentucky as a sort of firewall after seeing prescription-only laws pass in Oregon and Mississippi.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

Bristol-Myers-Squibb Cephalon imperial CEO pharmaceuticals power elite

Gusty 13:38 Add Comment

On the PharmaLot blog, Ed Silverman has two posts about how pharmaceutical executives continue to rake in humongous compensation whose magnitude seems unrelated to their performance or the performance of their companies. The CEO of Cephalon got more than $15.8 million, including the value of stock options, while the company is dealing with an Federal Trade Commission lawsuit which contends the company blocked sales of a generic competitor, and despite settling a suit about off-label marketing (see post here.) The CEO of Bristol-Myers-Squibb got $13.5 million after the company's stock price fell, the company took a charge for losses on sub-prime mortgages, and several top financial officers left (see post here.) Again, as we noted earlier, imperial CEOs seem rampant in health care organizations.

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

Baxter biotechnology heparin Mismanagement outsourcing pharmaceuticals

Gusty 11:30 Add Comment

We have posted several times, most recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.

All the heparin related to these events was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.)

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

By the end of this week, it became clear that the counterfeit ingredient was added to the heparin in China. Per Bloomberg,

The contamination was present in the powdered raw heparin purchased by Scientific Protein's plant in China, said Robert Rhoades, a pharmaceutical consultant with Becker & Associates in Washington, speaking for Scientific Protein. The company was unaware of the contamination at the time because it wasn't detected in tests Scientific Protein conducted on the powder provided by suppliers, he said.

Scientific Protein purchased raw heparin from consolidators and refined it further before sending it to Baxter, which uses the ingredient to make the finished drug, Rhoades said. The consolidators obtained the ingredients from workshops in China, he said.

The contaminant 'was very likely introduced at the workshop or consolidator level,' Norbert Riedel, Baxter's corporate vice president and chief scientific officer, has said.

Nonetheless, a number of experts suggested that there was reason not be complacent about drugs made in China. A Washington Post article noted that it was well known that Chinese manufacturers were liable to supply dodgy drugs,

Although the contaminated heparin is the largest and highest-profile instance of tainted prescription drugs made in China, it is not the first. In the late 1990s, a spike in deaths associated with the intravenous antibiotic gentamicin was linked to China-based Long March Pharmaceuticals. Although no definitive link was ever established, tests by German researchers later found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading them to write that 'it was assumed' the deaths 'were related to faulty manufacture.'

The Post quoted former US Food and Drug Administration (FDA) official William Hubbard,

The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one....

USA Today quoted former FDA Commissioner David Kessler saying that

the news shouldn't come as a surprise: China is 'as close to an unregulated environment as you can get.' In fact, it's a lot like the USA was in 1906, he says �'that's why we developed an FDA.'

Furthermore, one expert argued that Baxter International was ultimately responsible for the drug that it sold, per the Chicago Tribune,

The presence of a foreign ingredient raises new questions about Baxter's oversight because a lack of record-keeping at the China plant makes it more difficult for Baxter and government inspectors to trace the origin of the raw material for Baxter's product.

'Where are the controls here? What is the process here?' asked Carl Nielsen, who was the FDA's director of import operations and policy before leaving the agency to form a consulting firm in 2005.

'Ultimately, Baxter is the most responsible' for monitoring the quality of products that move through the company's pipeline, Nielsen said.

Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

Regarding the issue of active pharmaceutical ingredient that originated in China, Baxter's API supplier for heparin is in fact a Wisconsin-based company, Scientific Protein Laboratories, with whom Baxter and its predecessor in this business has worked for more than 30 years. SPL had been procuring heparin raw material from China for more than 10 years and opened a location in Changzhou, China, in 2004. Baxter worked with the U.S. Food and Drug Administration to obtain the appropriate approvals to work with this facility. For the API we receive from SPL, and for the API we receive from all our suppliers, Baxter performs quality testing of all incoming materials above and beyond what's required, to ensure that incoming API is what our suppliers claim it to be. Unfortunately, as the FDA has said, the problematic heparin API could not have been detected by the testing required of and done by any heparin manufacturer.

Previously Baxter International's CEO, Robert L Parkinson Jr, had dodged responsibility for the supply chain that provided the heparin to Scientific Protein Research's Changzhou facility, as we posted here, and as originally reported in the Chicago Tribune,

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

'It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier,' Parkinson said.

Yet if Baxter International is not responsible for the production of drugs that carry its name, who is? If Baxter International's executives are not responsible for how the drugs it sells are manufactured, who should be?

In an ironic juxtaposition, a small and little noticed news item last week declared that Robert Parkinson received $16,600,000 in compensation in 2007, a 30.5% increase from 2006. In fact, the company's 2008 proxy statement suggests even greater total compensation in 2007, $17,580,718. And Mr Arduini's 2007 compensation was reported to be $2,438,642.

The usual justification for compensation at this level is the brilliance of and great responsibilities borne by the executives who receive it. But, if Baxter International's executives will not take responsibility for their products and how they are made, what again is the justification for paying them the big bucks?

So the case of the contaminated heparin becomes another reason to question the imperial nature of the current leadership of health care organizations.

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

Baxter biotechnology heparin Mismanagement mission-hostile management outsourcing pharmaceuticals

Gusty 12:18 Add Comment

We have posted several times, most recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions. All the heparin related to these events was made by Baxter International.

We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

Now the US FDA just reported it identified a contaminant in the heparin that may be responsible for the adverse reactions. This has already been reported today by many media outlets, but I will quote Bloomberg since its article makes the main points most concisely,

Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was contaminated with a less-expensive ingredient derived from animal cartilage, U.S. regulators said.

The contaminant, over-sulfated chondroitin sulfate, isn't approved for use in medicine, said Janet Woodcock, the head of the Food and Drug Administration's drug division, in a conference call today with reporters. Regulators are investigating whether the substance was intentionally or accidentally added to raw heparin from China.

'It does not appear to have come straight from the pig,' Woodcock said of the contaminant. 'It doesn't appear to be a natural contaminant that got in there. We don't know how it was introduced or why.'

Adding the contaminant to raw heparin, the active ingredient in the finished product, would have been cheaper than using pure raw heparin, according to the FDA. The agency didn't know how much money would be saved by its use, Woodcock said.

Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The over-sulfated version found in the heparin was chemically modified to act like heparin, Woodcock said.

Over-sulfated chondroitin sulfate is generated in laboratories for experimental purposes, said Siobhan DeLancey, an FDA spokeswoman, in an interview. It is chemically altered to add additional sulfates, she said.

Two percent to 50 percent of the contaminated raw heparin samples tested by the FDA were made up of over-sulfated chondroitin sulfate, Woodcock said.

So it now appears, although it is not yet proven that the adverse reactions and deaths were caused not by a trace contaminant derived from a sloppy, primitive, and unsanitary manufacturing process, but from a bulk counterfeit ingredient deliberately introduced because it was cheaper than heparin, yet would fool purchasers into thinking it was heparin.

Thus we see what happens when US health care leaders were happy to put their prestigious logo on a drug whose source was unknown to them, presumably just to save some money. By obviously failing to exert rigorous oversight over how the drug which carried their company's name was produced, they not only allowed sloppy, primitive and unsanitary manufacturing practices, but apparently were easily snookered by counterfeiters who substituted a likely toxic ingredient for the real thing.

This was putting profits before patients. And the results were very bad for patients.

Baxter claims to apply

its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

However, rather than its expertise, its sloppy and uncaring leadership seemed to leave some of its patients' lives meaningfully worse.

This case is a glaring demonstration of why we need a new set of leaders of our health care organizations, and a new corporate culture within these organizations. Otherwise, failing to understand the health care context, and failing to put patients before profits will yield more sick and dead patients.

Princess Health and BLOGSCAN - Key Opinion Leaders. Princessiccia

Princess Health and BLOGSCAN - Key Opinion Leaders. Princessiccia

pharmaceuticals stealth marketing

Gusty 13:18 Add Comment

On the Clinical Psychology and Psychiatry blog is a pithy discussion of the use of "Key Opinion Leaders," (KOLs) to provide a veneer of apparent respectability to drug marketing. One KOL claimed, "trust me. I don't make that much," but it turned out had been paid $180,000 over two years to give talks about childhood bipolar disorder, a disease whose existence ought to be controversial.