Latest Drugwonks' Blog

If you think that Big Government knows best when it comes to what medicines are best, this news from the UK should help disabuse you of that notion.

Unfortunately, it’s only the most recent example of what happens when saving money takes precedence over saving lives.

We must not allow “evidence-based” medicine to mean “cost-based” medicine. Evidence-based must mean Patient-centric.

From BBC NEWS
Anger at bowel cancer drug ruling

Charities have criticised a proposal to block the routine NHS use of two drugs for advanced bowel cancer. The National Institute for Health and Clinical Excellence (NICE) said there was insufficient evidence to recommend Avastin and Erbitux.

But charities say both drugs are the best option for seriously ill patients whose cancer has spread.

They say the drugs have been shown to extend life expectancy by four to five months in some patients.

A similar decision has already been made in Scotland.

Bowel cancer kills almost 50 people a day in the UK. Each year, there are about 18,700 new cases in men, and nearly 16,200 cases in women.

It is easily treatable, but only if caught in its early stages.

Both the new drugs are monoclonal antibodies - the same type of new generation “biological” drug as the breast cancer treatment Herceptin.

NICE considered their use in patients whose cancer had spread, usually to the liver, but sometimes to the lungs. This is known as metastatic cancer.

We feel extremely disappointed that bowel cancer - the second biggest cancer killer - is not being given the attention or funding it deserves.

Hilary Whittaker
Beating Bowel Cancer


Avastin, known technically as bevacizumab, works by starving cancerous tumours of blood, thus preventing them from growing in the body.

Research has shown it can extend life expectancy by an average of five months.

Lynn Novak, from Crawley, West Sussex, who has advanced bowel cancer, argued that Avastin had reduced the size of her tumours and helped to keep her alive.

However, the NICE decision could mean she will have to stop taking the drug, as she cannot afford to continue to fund it herself, having already spent thousands.

Her only hope is to convince her local primary care trust she is an exceptional case.

“I’m a different person, a different person. It’s just given me a new life,” she said.

“I was told I had six months to live in December 2005, but I’m still here, I’m back at work, I’m a productive member of society, and I feel really, really well.”

‘Scarce’ resources

It’s just given me a new life.

Lynn Novak, who takes Avastin

Erbitux (cetuximab) works by blocking the proliferation of cancer cells, and is usually used after chemotherapy has failed.

In tests, it was found to extend life expectancy by at least four months for 50% of patients, and to shrink tumours by 50% in a quarter.

However, both drugs are relatively expensive. Avastin costs on average 16,824 pounds per patient, and Erbitux 11,739.

Andrea Sutcliffe, NICE deputy chief executive, said the institute’s investigations had found that neither drug represented a good use of “scarce NHS resources”.

Andrew Dillon, the chief executive, admitted the drugs were of some benefit - but said there was uncertainly about how good they were compared with current standard treatments.

Decision ‘scandal’

Television presenter Lynn Faulds Wood, who beat the cancer and set up the charity Lynn’s Bowel Cancer Campaign, said the decision was “cruel” to patients.

Hilary Whittaker, chief executive of the charity Beating Bowel Cancer, said the decision was a “scandal” and the value placed on the lives of sufferers seemed to be “minimal”.

“We are now the only nation in the EU not to offer cetuximab and bevacizumab to bowel cancer patients in the disease’s advanced stages,” she said, urging Nice to review its decision.

“We feel extremely disappointed that bowel cancer - the second biggest cancer killer - is not being given the attention or funding it deserves.”

Ian Beaumont, of the charity Bowel Cancer UK, said: “NICE’s negative decision with regard to the biological agents Avastin and Erbitux is further proof that the NHS is simply not working for bowel cancer patients and is overdue a full and comprehensive review.”

Professor Karol Sikora, a cancer expert at London’s Imperial Colllege, said: “These drugs are expensive but they are effective, trials have shown them to be effective.

“The difficulty for the NHS is they are costly. The way it is done is simply to calculate the amount of cost for prolonging survival by one year.

“The average NHS limit is around 30,000 pounds. That’s what you and I are worth to the NHS for one year’s extension of life.”

Alan Maynard, professor of health economics at the University of York, said the problem was NICE was saying yes too much, adding to the financial pressure in the health service.

The NICE decision is now open to consultation before a final ruling is published in the autumn.

All three bowel cancer charities receive financial support from the drugs industry.

D(uh)SHEA

  • 08.21.2006

Tenth Circuit Ruling Upholds FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids

Why is this important? Because it sends important messages to two different groups.

To those who would peddle dietary supplements as medicine the message is that the FDA has the authority to stop you if and when you cross the line.

And to the United States Congress the message is that DSHEA needs to be reformed — because the line has been crossed too many times.

Here’s the FDA statement …

Background: On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the Food and Drug Administration’s (FDA) final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States, reversing a decision by the District Court of Utah.

The Tenth Circuit Court of Appeals’ ruling demonstrates the soundness of FDA’s decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA.

FDA conducted an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency’s findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.

No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.

Amen.


Want to know what getting new drugs will be like if folks like Sid Wolfe, Chuck Grassley, Christoper Dodd get ahold of the FDA? Want an insight as to how a 21st century FDA will respond to the needs of patients if user fees are poured into more staff and reporting requirements for managing the risks of drugs after market? Read this article in the Chicago Sun-Times, Acne drug registry irritates patients: Rules for avoiding pregnancy delay treatment - 21 August 2006 Chicago Sun-Times - By Jim Ritter. Isotretinoin can wipe out severe acne but it can cause birth defects in pregnant women. “…Despite patient education efforts, at least 2,000 isotretinoin users have gotten pregnant over the years, “and this may be the tip of the iceberg,” according to March of Dimes.

Female patients must have pregnancy tests before, during and after taking isotretinoin, take two forms of birth control and answer questions on a Web site. Prescriptions last only 30 days, and must be filled within seven days of an office visit.

But critics say that iPledge, though well-intentioned, is cumbersome and poorly administered. Callers to the iPledge hotline have waited more than an hour to get through. Many patients have been unable to access their mandatory iPledge accounts. And even men and women who can’t get pregnant are required to enroll in iPledge, although their requirements are less stringent. In a recent letter to the U.S. Food and Drug Administration, Sen. Dick Durbin (D-Ill.) and seven other senators wrote: “Our offices continue to receive numerous complaints from doctors, patients and pharmacists about the inflexible and confusing requirements that have denied access to the drug to thousands of qualified patients.”

My advice: Don’t call Senator Durbin. Call Senator Grassley or Public Citizen or even Senator Enzi. If you think Ipledge is Irritating, just wait till it is applied for which every medicine the FDA thinks it needs political cover. Nothing like turning the Critical Path into an obstacle course for patients.


As someone who has benefitted enormously from the off-label prescribing of anti-convulsants, including gabapentin I find infuriating that this cadre of so-called researchers continue to imply that research conducted by private companies or on behalf of them is not only suspect but downright worthless and further, that off-label drug prescribing is based on an even more bastardized form such clinical information. That is not surprising since most, if not all, off-label uses are based upon clinical observations or a deeper understanding of disease mechanisms that are developed by the original use of the medicine. In fact, the critics — who have their own biases which are sustained by their own funding sources (thus, they too are financially conflicted) will be hard put to demonstrate any off-label use is any different than other domains of medical progress insofar as they are confirmed or disproved by clinical trials or rigorous observational data. People tend to forget that the first off-label use of a cancer drug (AZT) was critical in in the treatment of HIV patients or that the off-label use of thalidomide and Avastin have been associated with remarkable advances in treating cancer. The push to make off-label prescribing a criminal activity is a tragedy that will be measured in human lives…

Here’s an article from Drug Industry Daily that examines the often fine line between off-label promotion and the free and open dissemination of scientific information.

There are a number of interesting issues at play here — not the least of which is how immediately defensive and uncomfortable pharma industry antagonists become when they are asked to be as open and transparent as the industry they so brutally attack.

Here’s an inconvenient truth — When the anti-pharma gang have their feet held to the fire they get hot under the collar.

Regulatory Changes to Drug Marketing Necessary, Journal Article Says

The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an Aug. 15 article in the Annals of Internal Medicine says. But former agency officials challenge the constitutionality of the recommendations and whether the government is in the best position to police the system.

Pfizer subsidiary Parke-Davis instituted a wide-ranging strategy to promote off-label drug use in the 1990s, which is indicative of fundamental ethical problems with industry marketing, the authors wrote. The study also illustrates the failings of physicians, professional organizations and the pharmaceutical industry to police such practices, they said.

However, three of the authors of the article, Michael Steinman, Mary-Margaret Chren and C. Seth Landefeld, worked as expert witnesses in a lawsuit against Parke-Davis concerning that off-label use. Also, the data used in the article was obtained by a database set up by the attorney representing the whistleblower plaintiff in that case, the report’s disclosures show.

According to the study, “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,’ the company used advisory boards, consultants’ meetings and accredited medical education events to get doctors to prescribe its drug Neurontin (gabapentin), an anti-seizure medication, for off-label use.

These efforts, along with recruiting doctors to influence other physicians and developing research solely to boost market share of the drug, were done without proper disclosure, they said. For example, the company’s involvement with clinical trials, medical journal research and reviews, educational grants and continuing medical education was not provided, they allege.

These findings signal a need for change, the authors said. “There is widespread agreement that commercial interests should not influence the clinical decisions that physicians make on behalf of their patients.” To address this, a complex system has developed using disclosure and self-regulation by doctors, professional organizations and industry. However, these efforts have been “largely ineffective,” as illustrated by Parke-Davis’ promotion of Gabapentin, the study said.

Incremental changes will fail because “marketing is so deeply embedded” and “the borders between research, education and promotion are more porous than is commonly recognized,” the study added.

Instead, new approaches are needed, including “rigorous regulatory oversight, strict sequestration of commercial and scientific activities and a fundamental internal reevaluation of the interactions between individual physicians, professional organizations and industry.”

Consumer advocates agree that changes are necessary. There is a growth in off-label use, many times based on little or no scientific support according to William Vaughan, senior policy analyst for Consumers Union. “Fixing this problem has to be a major priority,” he told DID. In particular, the FDA must take a stronger oversight role of off-label use.

But Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, disagreed. The FDA does not have the legal authority to restrict the dissemination of scientific information because doing so would be an unconstitutional restriction on First Amendment free speech protections, he said. In 1998, the Washington Legal Foundation successfully challenged the constitutionality of FDA restrictions on speech regarding off-label uses of FDA-approved products. This is a “closed issue,” he said.

Information also should not be discounted based on the motivations of an industry sponsor. “The public health can often coincide with private gain,” Pitts added. “Pure research is often done for a number of reasons.”

Another former FDA official, David Adams, chair of the law firm Venable’s FDA Practice Group and former director of the policy staff in the Office of the Commissioner at the agency, says that doctors should play a central role in preventing improper marketing, not the agency. “The government’s ability to regulate these interests is constrained by finite resources and constitutional protections,” he said.

“The most potent player in this arena is the physician. They have control over where they get their information on medical products, where and why they speak about medical products, who pays for their [continuing education] and what they call on regulators to do,” Adams said. “The signals are sometimes mixed.”

Pitts noted that the connection between the authors and plaintiffs in the lawsuit against Parke-Davis undermines their credibility, calling the link “extremely suspicious.” He also noted that as industry members on advisory boards have their industry connections scrutinized, industry critics should also face the same standards.

A Pfizer spokesman responded in similar fashion. “I think the financial and other connections between two of the authors of the study and a plaintiffs’ lawyer who has brought a lawsuit relating the marketing of Neurontin speaks
for itself,” said Bryant Haskins, director of corporate medial relations for Pfizer.

But Vaughan rejected this view, arguing that the facts themselves, not the background of the researchers are the issue. “It is a distraction to argue who or where the people writing the report came from,” Vaughan said.* “The proof is crystal clear: They got caught red-handed and are now using red herrings to divert people from the obvious documentation. It is an extraordinary treasure trove of documents that shows what lengths marketers will go.”

Pfizer agreed in 2004 to plead guilty to federal criminal charges, enter into a corporate integrity agreement (CIA) with the HHS Office of Inspector General and pay $430 million to settle allegations that one of its units caused doctors to submit Medicaid claims for unapproved uses of Neurontin. In 2003, sale of the drug accounted for almost $2.7 billion in profits.
_______________________________________________________________________________
Here is a link to the article: http://www.fdanews.com/did/5_161/

* The technical term for this is “pot calling kettle black.” (Note: This is my comment and does not appear in the article.)

A Mine Romance

  • 08.18.2006

FDA, MIT to collaborate on drug safety
Associated Press

WASHINGTON - The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.

The system would scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns.

The current system relies on the largely manual assessment of reports voluntarily submitted to the FDA, sometimes months or years after an event has occurred. As a result, potential problems typically are underreported, said Dr. Scott Gottlieb, the FDA’s deputy commissioner for scientific and medical affairs.

A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies like the Veterans Administration, would be better at recognizing patterns suggestive of emerging problems, Gottlieb said.

The system would build on methods developed to identify infectious disease outbreaks, detect bioterrorism attacks and model the spread of bird flu, he said.

The FDA also plans to begin publishing reports for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.

Lawmakers and others have stepped up their criticism of FDA safety monitoring efforts in the wake of the pain killer Vioxx being pulled from the market in 2004.

One problem is the FDA cannot require that drug makers conduct studies on the safety of prescription medications already on the market, a recent Government Accountability Office report concluded.

Gottlieb said he did not think the FDA needed additional authority to improve its safety monitoring, according to a copy of a speech he gave Thursday at MIT’s Center for Biomedical Innovation.

Vioxx

  • 08.17.2006

I see today that Merck lost a lawsuit in which the plaintiff claimed that his coronary was caused by Vioxx; the fact that the patient needed a mutiple bipass operation apparently was used against Merck, the theory being that Vioxx never should have been prescribed for him, and would not have been had adequate warning been given.

Well. Assume all that to be true. Precisely how do we know that the heart attack would not have happened had the patient not taken Vioxx? As best as I can tell, we do not. And since the doctor presumably would like to avoid a malpractice suit, his testimony ought to be taken with a small grain of salt, even if in truth he is being wholly sincere. As the burden of proof is on the plaintiff—-even if only by a preponderance of the evidence—-it strikes me that yet again jackpot justice has reared its ugly head. Clinical trials can have only so many enrolled patients, as resources are limited always and everywhere, and so if an adverse effect of a drug emerges in, say, 1 out of 100,000 patients, it might not show up in a clinical trial substantially smaller than that. Is that “negligence?” The larger fear is that the pharmaceutical sector writ large will go the way of the vaccine sector, effectively destroyed because of litigation threats. Whom are future patients going to sue because better medicines were not available?

On the heels of an article in which she ridiculed Bristol Myers Squibb for being out negotiated by Apotex, the generic drug firm which is producing a copycat of the BMS blood thinner Plavix and a previous article about drug reps in which she failed to disclose one her main sources was also promoting a movie and book about her life as a drug rep, Stephanie Saul has hit a “gag me with a spoon” low with this weeks article lionizing the chairman of Apotex, Bernard Sherman. I will spare you all the details but give you all the delicious irony…

“….The opening chapters of a draft autobiography sit amid the hundreds of pill bottles and mound of legal documents in Bernard C. Shermanâs office. It will be the story of a brainy kid born in Toronto who becomes Canadaâs richest generic drug mogul.

Though a work in progress, it has the makings of a page turner. One chapter will recount how an employee from a brand-name drug company offered to sell him secret files. Another, he says, will describe how Mr. Sherman caught a rival stealing the recipe for a blockbuster generic developed by his company, Apotex.

But what promises to be the bookâs most riveting chapter is still unfolding. It is the part where Mr. Sherman seemingly outsmarts two big drug companies, Bristol-Myers Squibb and Sanofi-Aventis, to market the first generic form of the big-selling drug Plavix five years before its patent expires. And it could conceivably end with someone in jail….”

In jail? Gee, the last time anyone was tossed in the slammer in the pharmaceutical world, I think it was in 1989 after generic drug company employees were caught bribing FDA inspectors. Does Stephanie have any basis for asserting that anyone involve could be sent to prison? Any indictments? Convictions? Guilty pleas?

And as for illegality, it was Sherman (as Saul grudgingly notes) who was linked to a company that forked overr 500K for selling drugs illegally from overseas via the mail. A man ahead of his time. What a visionary. He tells our truthseeking reporting that he just gave the firm the drugs and didn’t know where they were headed.. Really.

Anyways, we also find out in this hardhitting piece that Mr. Sherman is Canadaâs “richest men with a net worth that magazines estimate at nearly $4 billion. He and his wife, Honey, give millions to charity each year. ” Somehow Stephanie has never mentioned (she had two chances) to note that BMS gives away hundreds of millions each year.

What does Mr. Sherman do for his dough? He launches lawsuits, Lots of them, in an effort to trip up a drug company on the soundness of a patent. He spends hundreds of millions a year in legal fees to make his money. A company like BMS has been pumping Plavix profits into new drugs for cancer, schizophrenia, arthritis, etc (I know, I know, spending money on marketing medicines too, G-d forbid)

All of which has nothing to do with why Apotex and BMS were dealing. Apotex launched a lawsuit to terminate the patent life of Plavix earlier than 2011. It was trying to negotiate money to cover the fines it would have to pay if the court ruled their lawsuit as without merit. And then at the same time he was writing Congress criticizing the sort of deals he was engaging in and explaining why — though his deal with BMS seemed like more the same, it really wasn’t. Stephanie takes this letter as proof that he was dealing in good faith. Or she puts it:

“The letter â addressed to Senator Charles E. Grassley, Republican of Iowa, and the Democrats Charles E. Schumer of New York and Herbert H. Kohl of Wisconsin â accurately predicted that the refusal would come within weeks.”

Bernard Sherman, a prophet in our time. And in Stephane Saul he has found his acolyte and Boswell.

http://www.nytimes.com/2006/08/15/business/worldbusiness/15drug.html?ex=1156392000&en=6a3e4b940f8d33ec&ei=5070&emc=eta1

This week Ben Cardin, a Democrat house member in Maryland and senatorial candidate in the Nov. election held a townhall meeting with seniors on health care and Social Security. Promises not to privatize Social Security received a lot of applause but a pledge to provide full Rx coverage under Medicare by imposing price controls on drug companies received a tepid response… Oops.

Meanwhile Cardin also promised to help cure cancer by 2015, doing Andy von Eschenbach one better (he set as a goal the end of suffering and death due to cancer by the same date)… Now given that all price control regimes limit access to cancer drugs and discourage innovation, just how does Cardin propose to achieve that?

Pipes Dream

  • 08.16.2006

According to our colleague Sally Pipes over at the Pacific Research Institute, “Gov. Arnold Schwarzenegger is promoting his new discount drug plan as a voluntary agreement between pharmaceutical companies and the State of California. But it’s more like a raw deal.”

“The California Prescription Drug Initiative calls upon drug manufacturers to offer five million low-income Californians huge discounts on prescription medications — up to 40% on brand-name drugs and a whopping 60% on generics.”

“Presumably, drug companies should offer these discounts out of the goodness in their hearts. But if they don’t comply? Well, then they’ll be coerced by the Terminator.”

Sally, as always, has a workable, free-market solution. She writes, “There is a better way.”

And here it is …

http://www.opinionjournal.com/federation/feature/?id=110008767

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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