February « 2009 « Medical Detox Programs in a stress-free environment

February 27, 2009

AstraZenaca’s Very Unscientific Seroquel Sex Scandal

Filed under: Big Pharma, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 1:25 pm

Did a senior company scientist’s sexual relationships with a company-funded researcher and a ghostwriter falsely elevate Seroquel’s efficacy and minimize safety concerns?

The latest bombshell among the thousands of ongoing lawsuits against AstraZeneca over its antipsychotic Seroquel is a tabloid editor’s dream: A high-level company medical exec engages in sexual shenanigans with a Seroquel researcher testing the drug, and also with the ghost-writer hired to write up the research results for publication in medical journals.

And it seems that if the sex wasn’t good enough to clinch the deal, evidence shows that the good doctor provided one of the women with “prescription painkillers” (this routinely means narcotics), and emails entered into evidence with both women demonstrate relationships based on “control and dependence.”

Court documents say that AstraZeneca’s former U.S. medical director for Seroquel, Wayne MacFadden, had sexual relationships with a contract British researcher who studied Seroquel, as well as an American ghostwriter who wrote the academic papers on the drug for publication.

McFadden, who no longer works at AstraZeneca, is alleged to have exploited the relationships resulting in compromised science. The researcher returned favorable research results, and the writer provided papers published in the American Journal of Psychiatry and the Journal of Clinical Psychopharmacology that are said to have been instrumental in the FDA’s approval of Seroquel for bipolar depression.

Wow, kids, it just doesn’t get any better than this. I’ve been scanning tabloid covers at the supermarket checkout to see if this stinker will displace Brangelina gossip and Bigfoot sightings. Probably not.

But just for fun, here’s a smattering of real headlines from recent British tabloids (they’re the most lurid in the world) with my imagined headline #10 at the end of the list. If you can think of a better one, leave it in the comments below! (Warning, no prize, just immortality.)

1.‘I Strip For God’!
2.Miracle Healings Performed By — A Turtle!
3.Most gals wait until third date to pass gas!
4.Scientists discover massive piece of dinosaur poop!
5.New Healing Miracles Of Jackie O Angel Painting!
6.Hubby sues ex: ‘Give me back my kidney!’
7.Yo-yo crime wave sweeps Singapore!
8.Former ruler denies use of zombie army!
9.Lovesick emu traps man in house — for two days!
10.Big Pharma quack nailed in sleazy sex-and-drugs love triangle!

For more details on this story, and the not-so-surprising people who are refusing to make any comments on the case, check out the Furious Seasons blog.

And for a good summary with related info about Big Pharma’s general propensity for compromising the integrity of scientific inquiry for marketing purposes, read the BusinessWeek article.

The fact that Big Pharma has been basing drug claims on tissues of lies and half-truths for years isn’t news any more. In fact, it’s just sad, especially if you’re old enough, like me, to remember that at one time the prescription drug industry was called the “ethical drug industry” to distinguish it from and elevate it above the snake-oil hawkers of the 19th Century.

Calling today’s drug marketers ‘snake-oil salesmen’ would give the original snake-oil guys a bad name.

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February 26, 2009

DOJ Joins Whistleblower Lawsuit Against Johnson & Johnson

Filed under: Big Pharma, FDA, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:26 am

Seeking repayment for federal health claims, the Department of Justice is continuing its war on Big Pharma’s rampant off-label marketing by joining two ‘whistleblower’ suits by two former sales managers against J&J’s Scios Inc., maker of heart drug Natrecor.

Two ‘whistleblower’ lawsuits against the Scios Inc. unit of Johnson & Johnson, alleging improper off-label marketing of the heart-failure drug Natrecor, has been joined by the federal Dept. of Justice.

The DOJ will seek repayment of as-yet undetermined amounts of Medicare and other federal health insurance claims it paid out for uses if the drug that were unapproved by the FDA.

As you know, physicians can legally prescribe drugs for off-label uses, but FDA regulations forbid drug companies from promoting such uses. But that is exactly what Scios did, and did in spades, claim the two whistleblowers, both former Scios sales managers.

The thing is, Scios’ marketing tactics for Natrecor is not news. Back in 2005, Dr. Eric Topol of the Cleveland Clinic charged in a medical journal that Scios was aggressively marketing Natrecor for repeated administration in outpatient settings for a “tune-up.” Yet Natrecor was approved by the FDA in 2001 only for a serious type of acute congestive heart failure accompanied by shortness of breath. Topol reported that Scios was even showing doctors how to bill Medicare for the off-label treatments.

Topol went on to describe the regimen the company recommended, using nearly 10 times the amount of the drug administered to acute-care patients in hospitals as approved, resulting in fees of as much as $700 per dose to the doctors.

Dr. Steve Nissen, who later succeeded Topol at the Cleveland Clinic as cardiology chief, was the only FDA adviser to vote against Natrecor, after he found research that tied it to an increased risk of death. Nissen, as you might recall, has become known as a whistleblower of sorts himself, publishing medical journal articles warning about the real risks of the diabetes drug Avandia, the painkiller Vioxx, the anticoagulant Exanta, and the blood pressure drug Vanlev, among others.

According to the Wall Street Journal Health Blog, in cases where the DOJ seeks to recover damages based on federal health coverage paid for off-label uses, state attorneys general often join in, and the stakes can be high. A few weeks ago Pfizer took a $2.3 billion charge for off-label marketing of the painkiller Bextra after a federal probe.

GlaxoSmithKline also took a $400 million charge for marketing and promotional practices for several products recently, and Eli Lilly paid $1.4 billion in a recent settlement over marketing for its antipsychotic Zyprexa. And, a few months earlier, Cephalon agreed to a $444-million settlement in state and federal probes of its sales and marketing practices.

The FDA, while failing to protect Americans from health risks associated with drugs, has demonstrated no capability of policing the illegal financial gouging by criminals in the pharmaceutical industry who flaunt the FDA’s own rules. Without an aggressive DOJ, a few members of Congress, and occasional Big Pharma whistleblowers, we’d have no one trying to protect us.

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February 24, 2009

Pfizer Follows Lilly, Merck and GSK Into The Sunshine

Filed under: Big Pharma, Eli Lilly, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 9:32 am

The Grassley-Kohl Physicians Payments Sunshine Act is not yet through Congress, but Big Pharma is jumping the gun with some transparency promises, perhaps hoping to head off the Act’s more stringent requirements.

Pfizer has announced it will start reporting financial contributions to doctors beginning in July this year. Payments for clinical trials, speeches, consulting, gifts and meals will be posted on the company’s Web site starting early next year.

Pfizer pledged to disclose payments that total more than $500 yearly, including non-monetary items whose value exceeds $25. The new Physician Payments Sunshine Act of 2009, sponsored by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), requires pharma and biotech companies to report all payments over $100. Those that failed to comply would incur a $1 million dollar fine.

Last year Lilly, Merck, and GlaxoSmithKline also announced that they would begin reporting payments and honoraria to physicians, each with its own idea of what it is willing to divulge.

It looks like Pfizer is taking its cue from a similar transparency bill that failed to get Congressional approval back in 2007. It required a $500 reporting requirement.

According to a report at PharmaExec, Dr. Ted Epperly, president of the American Academy of Family Physicians, said the new version of the Act approaches micromanagement.

“It’s a bit regressive. It goes backwards instead of forwards in terms of reporting requirements,” said Epperly. “We agree that we ought to have transparency, openness and honesty on this, [but] there can be a point where it just crosses the line of being too burdensome.”

I can’t help wondering what Epperly is really going on about. Family physicians certainly won’t suffer any inconvenience from the Sunshine Act. Could it be that they might not get as many free lunches and pens?

And meanwhile, any micromanaging is going to be taking place over at Big Pharma’s and Biotech’s house, not the family doctor’s office.

Big Pharma won’t have a choice, says the PharmaExec report, if the bill is pushed through. With the state of the economy, and the new Obama administration promoting transparency in big business, the new Sunshine Act could gain more momentum this time.

Let’s face it. Big Pharma is jumping on the bandwagon early to dazzle Congress and head off passage of the new bill, which has more stringent requirements. The theory goes that if enough congressmen get the wacky idea that Big Pharma is willing to ‘self-police’, they’ll nix the Act and it will die like the 2007 bill.

I hope the Act makes it through Congress unscathed, and that Pfizer and the rest of Big Pharma and Biotech are made to hew to it exactly.

We all know how ethically Big Pharma plays when left unwatched in the sandbox.

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February 23, 2009

FOX News Tampa Urges Florida Prescription Monitoring Program

Filed under: Novus Medical Detox, drug addiction, medical drug detox, prescription drug addiction — Rod Malcolm @ 7:29 am

“Novus Medical Detox clinical director Steve Hayes discusses prescription drug addiction with Tampa Bay’s Fox News 13 medical reporter Dr. Joette Giovinvo.”Addictions and deaths from controlled prescription drugs are soaring, and Florida legislators are being pressed to sit up and pay attention.

Since 2002, nearly 40 states have taken advantage of an annual federal grant program to assist the establishment of, or enhance existing, state-level prescription drug monitoring programs, and most remaining states are planning such programs.

A few, notably Florida, have repeatedly failed to pass legislation establishing prescription drug monitoring. Legislators cite privacy concerns, saying their constituents are worried that their private patient information could somehow be compromised. Others worry a drug monitoring registry might keep meds from patients who need them. Yet to date, there’s been no credible evidence for such concerns.

Prescription drug monitoring programs track doctors’ prescriptions by licensed pharmacists, recording the identity of patients, drugs, physicians, dates and a few other details. Information is accessible only to pharmacists, doctors, and some regulatory agencies. It is designed to be shared by participating states and the feds. The program has already proven helpful in reducing “doctor shopping”, one of the most significant factors enabling prescription drug abuse across the country.

Recently, Tampa Bay’s FOX 13 News carried an item describing the situation in Florida, where narcotic painkillers are killing record numbers of citizens every year. Deaths from drugs like oxycodone and fentanyl have more than tripled in the state since 1998, Fox News said. You can watch the news video here.

The station’s Dr. Joette Giovinco, popularly called “Dr. Jo” by viewers, focused on the plight of Brent Brown, a Florida realtor who became dependent on Xanax, prescribed for ‘restless leg syndrome’ and trouble sleeping. As his drug tolerance went up, more drugs from more doctors left him wired on at least four different medications. The years-long nightmare finally ended after a brief stay at Novus Medical Detox in Pasco County, Florida, where easing patients through drug or alcohol withdrawal is accomplished using state-of-the-art medical protocols.

Dr. Jo visited Novus, where clinical director Steve Hayes confirmed the rising death toll across the country from methadone, oxycodone, OxyContin, fentanyl and other prescription narcotics, what he says are basically “legal heroin.”

“A lot of our patients that come in here talk about how easy it is to go out and get these drugs,” Hayes told Dr. Jo, alluding to the widespread practice of doctor-shopping by addicts, and also the fact that far too many doctors are too quick to prescribe narcotics.

Hayes described the benefits of a computerized registry that allows doctors to see if a patient has already received a prescription for narcotics somewhere else, and when.

Although Florida’s legislation has been repeatedly voted down, albeit by narrow margins, a county pilot program is underway and looks promising. There is hope among many lawmakers now that when the bill is reintroduced in May, it will finally receive approval. If so, it could take effect as early as July this year.

Because of his successful recovery at Novus Medical Detox, Brent Brown has been completely drug free for over a year, said Fox News, is back at work, and is helping others become free from prescription drug addiction.

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February 18, 2009

Spine Doctors Get Tough On Device Maker Payments

Filed under: pharmaceutical giants — Rod Malcolm @ 11:30 am

The North American Spine Society will sanction its 5,000 members who fail to disclose not just financial ties, but actual dollar amounts of payments from medical device-makers.

Ongoing Congressional investigations being led by Sen. Charles E. “Chuck” Grassley (R, IA) into academic and medical financial ties to medical device-makers have prompted the North American Spine Society to introduce stringent new financial transparency requirements from its 5,000 members.

The Wall Street Journal reports that the initiative “is a response to pressure from lawmakers, prosecutors and lawsuits by companies’ former employees. Prominent surgeons doing research have been found to have significant financial relationships — sometimes to the tune of millions of dollars — with medical-device firms.”

We’ve been following Sen. Grassley’s inquiries into how Big Pharma’s financial tentacles are wrapped around research, continuing education and marketing to physicians. This is the first major story we’ve seen concerning medical device makers.

The spine society will require researchers and consultants to disclose full details including dollar amounts of their financial ties to medical-device companies, or be subject to sanctions that can include suspension, expulsion or public letters of censure. The sanctions would have no effect on ability to practice, only on membership.

The spine society’s ethics-committee chairwoman, Marjorie Eskay-Auerbach, an orthopedic surgeon in Tucson, AZ, told the WSJ it became clear that more transparency is better, and that she doesn’t know of other professional groups or journals with similarly stringent disclosure rules. Whether mere disclosure is enough to deal with conflicts of interest, it’s at least a first step, she said.

Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, said she knows of no other such policy. But she told the WSJ that she and other top medical-journal editors plan to discuss it at a June meeting.

The WSJ said that, according to a Senate committee, medical-implant makers Zimmer Holdings Inc., Stryker Corp., the DePuy orthopedics unit of Johnson & Johnson, and Biomet Inc. have paid more than $221 million to surgeon “consultants” in recent years.

Medtronic Inc. has been accused by former employees, and the government, of inducing surgeons to use its spine products through questionable payments. In 2006, the Minneapolis company agreed to pay $40 million to the feds to settle civil charges that it paid kickbacks to doctors.

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February 17, 2009

Ely Lilly CEO Was Paid $13 Million Last Year — A 39% Pay Increase

Filed under: Big Pharma, Eli Lilly, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:21 am

While the company’s stock price tanked and product liability suits flourished, Lilly’s top executives were rewarded with a total of $48 million compensation in 2008.

The Indianapolis Star reports that Ely Lilly’s new CEO John Lechleiter was paid $13 million last year, a 39 percent increase from 2007, according to a regulatory filing.

Lechleiter, 55, became chief executive in April and added the title of chairman last month, replaced outgoing CEO Sidney Taurel, now chairman emeritus. Taurel received a $40-million retirement package for his years of service.

FiercePharma says Lilly’s board gave Lechleiter credit for snatching ImClone Systems out from under Bristol-Myers Squibb’s nose in a $6.3 billion buyout last year, and praised him for the company’s 9 percent sales growth to $18.6 billion, although Lilly posted a $2.07 billion loss for the year largely due to the ImClone acquisition.

Here’s the rundown on Lilly’s compensation, comparing 2008 to 2007:

You might or might not recall that it was an internal email from Lechleiter to his underlings several years ago, urging them to push off-label uses for Zyprexa, that added to the legal flames during the State of Alaska’s lawsuit against Lilly seeking reimbursement for medical costs of Medicaid patients who developed diabetes while taking the schizophrenia drug for off- and on-label uses. As reported in the New York Times last year, Lechleiter noted to other Lilly officials that company representatives were already promoting Strattera, another Lilly psych drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, to encourage the use of Zyprexa by children and teenagers, he said.

Ahhh, we live in interesting times.

You might also recall ImClone from the media-madness of a few years ago when fashionista-homemaker-media-maven Martha Stewart went to jail for lying to the feds about dumping her ImClone stock on the insider-advice of the company’s founder Sam Waksal, who was convinced that because of the FDA’s problems with ImClone’s cancer drug Erbitux that stock prices would tank. Oh yeah, and Waksal had also been dating Stewart’s radio-host-personality daughter Alexis, nearly 20 years his junior.

Anyway, Waksal wound up in the slammer too, for insider trading, but he also pleaded guilty to charges of securities fraud, bank fraud, obstruction of justice, perjury, conspiracy and wire fraud. Waksal became a free man just this month, but as Mike Huckman at CNBC reports, it’s ironical poetic justice that the ImClone’s cancer drug — and the company’s development pipeline — turned out to be so good, and so promising, that Lilly stepped up with the $6.3 billion buyout of ImClone in a bidding war with Bristol-Myers Squibb — long after Waksal was history at his own company.

These are the kinds of things that make Big Pharma, well, ‘Big Pharma’. Remember when doctors and their wondrous ‘miracle drugs’ were there just to help? Was it all just a dream?

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February 12, 2009

FDA’s Planned Narcotic Regulations Should Include Broader Education

Filed under: Big Pharma, FDA, OxyContin addiction, drug addiction, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 12:31 pm

Soaring death and injury rates from dangerous opioid painkillers are being caused by physicians’ inappropriate over-prescribing, along with Big Pharma’s aggressive, illegal marketing. What’s needed is more education, and alternate forms of therapy.

A New York Times article reports that new rulings expected from the FDA will limit or remove many physicians’ rights to prescribe several of the most addictive and dangerous narcotic painkillers.

But is this really the only solution to a dreadful situation?

Reiterating that situation, The Times states that “hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic [a brand of fentanyl] or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.”

FDA Black Box warnings and Public Health Advisories in recent years have accomplished little, since the numbers of narcotic painkiller prescriptions continue to soar, and addictions, injuries and deaths are growing apace. The 24 versions of narcotics on the FDA’s list were prescribed 21 million times in 2007, for nearly 4 million patients.

The drugs being considered for restricted uses are listed on the FDA web site, and include various brand and generic versions of fentanyl, methadone, morphine, oxycodone, hydromorphone and oxymorphone. The products listed are made by 15 different drug companies. The FDA is calling for meetings with manufacturers, patients’ groups, consumer health activists and the public beginning in early March, seeking ideas about how to implement the new regulations.

But it’s a complicated situation, because many physicians and patient advocate groups continue to complain that chronic, serious pain is under-treated in America. Simply cutting the availability of the drugs isn’t a solution, they say, since it does less than nothing for those whose lives are ruined by genuine chronic pain, and could increase their numbers.

It seems to me that what’s needed is more, and better, education about pain, narcotics, and pain relief in general. And not just for doctors, but also for patients.

Physicians need more and better education on the realities of opioid use and abuse, including the scientific fact that, in the long run, many opioids actually cause more pain than they relieve. And doctors should also have their closed minds opened to every alternate form of pain therapy that has ever shown any efficacy or promise.

Patients need to be better informed too — and much more closely followed — when they’re prescribed opioids. And they should also be offered alternative forms of pain therapy whenever possible — anything is better than a narcotic if it will do the same job.

Continuing Medical Education (CME) on opioids should be mandated right away — it’s been talked about for years, and is long overdue. Meanwhile, medical schools need to expand education in narcotics, and they should add classes on the many alternate approaches to pain relief that exist, and are in common use all over the world.

In other words, dangerous pharmaceuticals are not the only answer to a lot of the pain out there. Medicine has got to unbend and really start caring for patients.

And speaking of Big Pharma, it should be kept several arm-lengths away from all education on the subject. We know where Big Pharma is coming from — it’s mostly about marketing, with little left over for patient safety, and zero for alternative therapies.

Doctors, who are supposed to be dedicated to patient health and the old “do no harm” dictum, are too quick, even fatally so, to prescribe narcotics, ignoring potentially helpful therapies — some that have demonstrated efficacy for thousands of years — that don’t carry risks of addiction, injury and death.

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February 11, 2009

Judge Upholds Decision Barring Purdue Execs From Federal Health Care

Filed under: Big Pharma, FDA, OxyContin addiction, pharmaceutical giants, pharmaceuticals, prescription drug addiction — Rod Malcolm @ 8:53 am

An administrative law judge has upheld a decision barring three former executives of Purdue Frederick, an affiliate of Stamford-based Purdue Pharma LP that makes OxyContin, from federal health programs for 15 years.

Comparing the three chief executives of a pharmaceutical company to the Third Reich’s Adolph Hitler, Hermann Goering and Heinrich Himmler may seem a stretch to some people, but to those harmed by a prescription drug, and to the loved ones of those killed by that drug because the drug’s hazards were criminally misrepresented, the comparison isn’t that far off.

In 2007, Purdue Pharma and Michael Friedman, its then-chief executive officer, Dr. Paul Goldenheim, then-chief scientific officer, and Howard Udell, then-general counsel, pleaded guilty to misleading doctors and patients from 1996 to 2001 as to OxyContin’s addictiveness by promoting it as a low-risk painkiller.

As is now well known, the three executives were charged with one count of misdemeanor misbranding of OxyContin, served no prison time, and paid a total fine of $34.5 million. Purdue Pharma pleaded guilty to felony misbranding of OxyContin and was ordered to pay $600 million in criminal and civil penalties and forfeitures, including $100.6 million to the U.S. government and $59.3 million to repay state health programs and Medicaid.

Last week, reports the Stamford Advocate, Judge Carolyn Cozad Hughes found that Friedman, Goldenheim and Udell had the responsibility and authority to “prevent or correct” Purdue Pharma’s misbranding but “failed to do so,” according to the Office of the Inspector General. The judge then upheld an earlier court decision barring the three executives from participating in federal health programs for 15 years, following an action brought by the Office of the Inspector General for the Department of Health and Human Services.

Now the top three execs are barred for 15 years from Medicare, Medicaid and other federal health programs. Purdue Pharma says it will appeal the decision. But we’d bet that the three multimillionaires are comfortably wrapped in sumptuous private health care plans, and that Medicare and Medicaid are the last things they personally need. In fact, we’ve wondered how everyone involved escaped jail time.

A missing figure in the case might have included a marketing executive or two, or whoever it was that personally, hands-on, directed the felonious “promoting” of OxyContin. This would have let us add Paul Josef Goebells, the Third Reich’s Minister of Public Enlightenment and Propaganda, to our imagined list of OxyContin mass murderers.

Nazi war criminals were responsible for the deaths of tens of millions and the misery of hundreds of millions. With OxyContin, it’s simply a matter of scale. When it comes to a death in the family, the scale is “one”. Marianne Skokel, of Baltimore, lost her 29-year-old daughter, Jill, in 2002 to an OxyContin overdose. She tells The Advocate that she doubts the Office of the Inspector General’s actions will change the former executives or the company.

“I don’t think they know how to conduct business honestly,” she said. “They’re felons.”

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February 10, 2009

FDA Wants More Study Data, Denies Gardasil For Older Women

Filed under: Big Pharma, FDA, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:16 am

Merck’s Gardasil, approved for females from 9 to 26, has been a successful new product thanks to agressive marketing, but regulators want to see more study results before approving it for women aged 27 to 45.

FDA has again withheld approval for Merck’s cervical cancer vaccine Gardasil for women aged 27 to 45, until they evaluate longer-term test results. Merck’s first request last year based on 24 months of results from an ongoing 48-month study was also refused.

Gardasil, a recent Merck success, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. Aggressive marketing — critics consider it overly aggressive — even pushed state and local lawmakers to mandate its use among school children and immigrants.

Riding on the wave of massive sales, Merck began expanding its horizons to include the older female age groups and males. The FDA refusal letter does not affect Merck’s application to expand use to males.

Some medical experts consider Merck’s marketing claims to be inaccurate or at least misleading, and the cost of the vaccines to be exorbitant, because the vaccine only protects against a few forms of cervical cancer already easily detected by other means, such as the Pap Smear, which are readily available, widely used, and much less expensive.

Any connections between Gardasil and numerous serious adverse events, including paralysis, fainting and collapse, hallucinations, and even death, are strongly denied by the company.

An MSNBC report says Gardasil’s strong sales has waned, because the target age group is becoming saturated, and also that the vaccine is facing competition from GlaxoSmithKline’s similar product called Cervarix.

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February 9, 2009

UK Recommends Phasing Out Big Pharma CME Support

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:25 am

Great Britain’s Royal College of Physicians, which is in charge of accrediting continuing medical education, has recommended that pharmaceutical and device industry funding of CME be gradually eliminated.

A working committee put together by the UK’s Royal College of Physicians has recommended that industry funding of continuing medical education be phased out, and replaced by alternative sources of funding not connected to any commercial interest.

Chaired by Richard Horton, editor of The Lancet, with representatives from the pharmaceutical industry, academia and the UK National Health Service, the work group addressed specific problems that resonate loudly here in the USA.

Surveys of patients, physicians, the pharmaceutical industry and the UK’s National Health Service (NHS) identified a number of critical threats to clinical research in the UK, around two key themes: Patient disillusionment with medicines policy, and a failure of trust between the NHS and the pharmaceutical industry.

Evidence submitted to the group suggests that patients remain concerned that they do not enjoy equal access to medicines, nor do they believe that the full range of innovative medicines that are available is brought to their to attention, undermining their confidence in the entire prescribing process. Patients also confirm a willingness to participate in clinical trials, or other drug related research, but report a lack of opportunity.

There are also major issues in the relationship between industry and the medical profession in recent years, with education being one of the most contentious areas. Well respected physicians contend that continuing professional development programs are too dependent on industry support, while the industry cites widespread ambivalence within the NHS and academia towards working with them as a key obstacle to future innovation.

The group made 42 recommendations to redefine the terms of engagement between the NHS, academic medicine, and the pharmaceutical industry, with the health and well-being of the patient as the over-riding objective:

Decoupling the pharmaceutical industry from continuing professional development [Great Britain’s term for continuing medical education] to address widespread suspicions that drug promotion is carried out through continuing professional development.

The creation of a program that could provide independent sources of evidence about the effectiveness of different prescription drugs for consumers.

The creation and adoption of consistent ethical guidelines regarding relationships between doctors and pharmaceutical companies.

Better collaboration among medical researchers from government, academia, and industry.

Here in the US, where the same kinds of issues are daily news, the Accreditation Council for Continuing Medical Education (ACCME) sets and enforces standards in physician education. The Council’s seven member organizations are the American Board of Medical Specialties (ABMS), the American Hospital Association (AHA), the American Medical Association (AMA), the Association of American Medical Colleges (AAMC), the Association for Hospital Medical Education (AHME), the Council of Medical Specialty Societies (CMSS), and the Federation of State Medical Boards (FSMB).

The primary responsibilities of the ACCME are to:

Accredit institutions and organizations offering CME

Define criteria for evaluation of educational programs and ensure compliance with these standards

Develop methods for measuring the effectiveness of CME and its accreditation

The lead-in to the summary of the UK group’s report states:

“Unless points of contention between the pharmaceutical industry and the medical profession are resolved satisfactorily, future advances in the quality of patient care may be put at risk.”

We applaud the UK’s Royal College of Physicians for taking the lead and addressing these issues. We urge ACCME to make a careful reading of the UK report and take deliberate action to address the grievous profits-ahead-of-patient-care situation that exists here in the US.

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