Latest Drugwonks' Blog
Merrill Goozner criticized us (or me) for being pro-industry enroute to explaining why I did not post anything on the stem cell legislation vote last month. That logic is convoluted. Goozner is assuming that the drug industry is conservative, and therefore opposes stem cell research and that I am conservative and oppose stem cell research and that therefore as a tool of industry I did not write something that my minders would not like….. Actually, considering that industry supported the California bond initiative and would stand to benefit from stem cell research, that I wrote an oped in the Washington Times in favor of stem cell research Goozner’s logic is shall we say, about as good as his reporting? PS Merrill, CMPI is NOT part of the Manhattan Institute…or do facts not matter in your left wing world?
In any event, heres a post on stem cell research. The latest experiment coming from Advanced Cell Technology — a followup to it’s research with mice embryo’s demonstrate that it is possible to produce stem cells without harming or destroying embryos. According to an article on WebMD:
“ACT researchers Irina Klimanskaya, PhD; Robert Lanza, MD; and colleagues used a technique called preimplantation genetic diagnosis, or PGD; it is used during in vitro fertilization techniques. This basically means plucking out one of the eight cells from a blastomere, a very early stage of embryo development.
Such “biopsied” embryos are perfectly healthy and, after implantation in a woman’s womb, develop into normal fetuses. More than 1,500 PGD children have been born.
The researchers cultured 19 stem-cell-like “outgrowths” derived from these harvested stem cells. From these, they were able to get two stable lines of human embryonic stem cells. Under proper conditions, these cells showed the potential to become any cell type of the human body.
Klimanskaya and colleagues predict that the technique will become more efficient in the future.
“Blastomere-derived human embryonic stem cells could be of great potential benefit for medical research, as well as for children and siblings born from transferred PGD embryos,” they conclude.
The findings appear in an advance online issue of the journal Nature.”
For some, even this will be a bridge too far. But for the vast majority of Americans, this approach, if reproducible and usable will settle the debate since such biopsies are already done. Opponents will find themselves increasingly isolated because their position will have shifted to fit the shift in science. The NIH should at the very least provide federal funding to replicate the ACT research.
CMPI Board Member, friend and inspiration Suzanne Pattee is the July 2006 recipient of the Heroes of Hope Award. The award is given by The Heroes of HopeÃ¢Â¢ Living with CF Program Advisory Panel. It is given to recognize people with CF who give hope and serve as role models to others. Chosen from a nationwide pool of candidates, Suzanne received the honor for her ability to inspire others with CF through her positive attitude, strong community outreach, and her outstanding commitment to proactively manage her health. Suzanne, a Virginia resident, will be joined by family, friends, and her CF care center team to receive her award today, on August 23,during a ceremony given in her honor at the Johns Hopkins Hospital Adult CF Program.
I have known Suzanne for over ten years. We have rarely talked about her illness. But she is a living example of what the combination of determination and medical innovation can do to provide people with longer and fruitful lives. We both remember the time that the Clinton folks — when they were planning to reinvent health care — told companies working on CF drugs that it would be more cost-effective to focus on diseases with larger populations. (That’s right people, it takes a village to ration care.) And even now, people with CF find their access to new medicines in Canada and Europe rationed and limited and delayed. Thankfully, Suzanne has fought against that dark movement here in America. Her accomplishments are many and I wish everyone that purports to care about medical progress had half her courage and passion!
Here’s more about this remarkable woman from the press release issued about her award:
“Suzanne has grown to be an extraordinary leader in the CF community,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation who has been a colleague of SuzanneÃ¢s for more than 20 years. “The depth and richness of her experience, including her law degree and previous work with the biotechnology industry, has contributed to her skills to benefit the CF community at large. Never have I known a more intelligent, quick-witted and above all, determined individual Ã¢ Suzanne is clearly an inspiration to us all.”
Suzanne has faced CF head-on since she was diagnosed at 6 months of age after experiencing common symptoms including pneumonia and failure to thrive. At that time, the median age of survival for someone with CF was five years. According to the CF Foundation’s National Patient Registry, the predicted median age of survival is now 36.8 years. Today, at the age of 43, Suzanne realizes that her experience with CF is not typical and feels extremely lucky in her life. She views having CF as a surmountable hurdle and, at times, a blessing in disguise as it allows her to interact with and be inspired by others with CF whom she might never have had the chance to meet.
Not one to take a back seat approach to issues she is passionate about, Suzanne first began educating others about CF as a CF Foundation poster child at age six. She has worked with the CF Foundation for 14 of the past 20 years, and leverages her insight as an attorney in her current position as the CF FoundationÃ¢s Vice President of Public Policy and Patient Affairs. In this role, she advocates for people with CF with the U.S. Congress and the Administration, and spearheads the CF FoundationÃ¢s focus on adults with CF.
“The Heroes of Hope Living with CF program is proud to recognize Suzanne for her tireless dedication to providing legal and emotional support to those with CF who desperately need it,Ã¢ said Lisa Yourman, Heroes of Hope Living with CF Advisory Panel member and CF advocate. Ã¢By promoting the rights of CF patients nationwide and selflessly dedicating her life to help others overcome and persevere through CF and other challenges, Suzanne is an ideal recipient of the Heroes of Hope award.Ã¢
Through her steadfast work with the CF Foundation, Suzanne is faced daily with the trials CF brings to children, adults and families. She uses this as her inspiration to help lessen the burden of CF on others by fighting for federal and state policies to ensure access to life-saving CF medication and specialized CF care. Suzanne has been a leader in bringing adult-related CF issues to the forefront of the CF communityÃ¢s agenda, and was an initiator of the CF FoundationÃ¢s infection control policy guidelines that seek to reduce the risks to people with CF from potential cross infection.
Suzanne strives to live every day with meaning and passion. Suzanne recognizes the critical importance of consistently following her daily medical regimen, which consists of inhaled medications, antibiotics, digestive enzymes, nasal irrigation and chest physical therapy. Suzanne makes regular physical exercise a part of her routine, including activities like dancing and swimming, and is careful to monitor and care for her CF-related diabetes.
She also enjoys spending time with her friends and family, including her 11 nieces and nephews, playing with her dog, Daisy and singing along with Broadway musicals.
When Arnold Schwarzenegger returns to the silver screen, his first movie should be called Total Lack of Recall.
Last November, citing his support for the free market, the Governor campaigned against Proposition 79, a plan that would have placed price controls on prescription medicines. Prior to that, in his State of the State speech and in a widely discussed letter to Congress, Schwarzenegger pointed out that it is unfair and inappropriate that American consumers bear a disproportionate share of the cost of developing new medicines that benefit the whole world. He encouraged the Congress to demand an end to price controls in foreign countries and vigorously support those pharmaceutical and biotech companies who refuse to sell their products to countries imposing price controls.
Today he supports a plan almost identical in its folly to Proposition 79. Yep, in a strange rhetorical twist, he was against it before he was for it.
Total Lack of Recall. But that was then and this is, well — closer to the Governor’s battle for reelection.
“This (the Governor’s initiative) is a huge victory for the needy,” said Assembly Speaker Fabian Nunez (D-Los Angeles). “This goes a long way toward correcting the wrong that was done at the ballot box in November.”
“Correcting the wrong?” What Speaker Nunez means is that it goes a long way to legislating something the citizens of California voted down only 10 months ago. So much for the will of the people.
Or, for that matter, the needs of the people — particularly the most needy.
Under the proposal, doctors who wanted to prescribe de-listed drugs would first have to obtain specific permission from Medi-Cal — a bureaucratic burden. Though they are supposed to receive such authorization within 24 hours under federal law, some doctors say the actual process is far more tortured.
“Docs in community mental health are besieged with clients. They’ll have hundreds of clients with severe psychiatric disabilities assigned to them,” said John Buck, chief executive of Turning Point Community Programs, a Sacramento-based mental health nonprofit. “There’s always somebody in a crisis, and you’re talking about filling out more paperwork?”
For that reason, according to an article in today’s LA Times, advocates for the poor object to the involvement of Medi-Cal.
Loretta Jones, executive director of Healthy African-American Families, a nonprofit group based in Los Angeles, called the plan “abominable.”
“We’re taking our poorest population — which are usually women and children — and you’re making decisions about their healthcare that you would not make for a Blue Shield or a Health Net” population, she said.
With California’s new program, the Governor’s new moniker could be “the Abominable No-Man.”
Actor Schwarzenegger’s Total Recall might have been a hit, but Governor Schwarzenegger’s Total Lack of Recall is a dangerous, shortsighted miss.
The President went to Miinnesota to sign an executive order that will require federal agencies to ” compile information about the quality and price of care they pay for and share that information with their customers and each other. ”
In a statement made before the signing, Health and Human Services Secretary Mike Leavitt said, “It’s just the American way. We clip coupons. We check for bargain flights on the Web. We carefully research major purchases. But when it comes to health care, we lack the tools to compare either quality or the costs.”
Some might think the comparision facile. And to be sure, comparing the price of hip replacements is a bit different than comparing the price of flights to Florida. But, as the part D experience shows, it’s a start. And the Bush administration knows that price is not everything. Which is why, the prices will include all services requires for treatment — doctor services, drugs, rehab, etc — for treatment. Efforts are being made to organize comparisons around INTEGRATED care for disease or condition as well as prevention of illness or recurrence. Quality standards would have to adjust accordingly. As Alez Azar, the HHS Assistant Sec who is the point person on this initiative has noted, the Center for Medicare and Medicaid Services has ongoing efforts to measure quality and data collection efforts that private plans can already tap into or emulate as a platform. CMS has already provided a lot of information on prices and process measures that people can use to make comparative decisions. It just posted price information for 61 procedures in outpatient centers. ( http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1948) And this in initiative bolstered by the Bush exec order will roll out transparency efforts in six regions around the country.
Of course, there are many private quality initiatives. Aetna just announced it would post price data on common services and procedures. CMPI’s own board member, Susan Horn is a pioneer in the effort to integrate the continual measurement of quality into integrated care management. Go to www.isisicor.com for more info.
But the first step is to get the data systems up and running, online and as convenient to use as cellphones or ATMS. (Which means the same information has to be available in real time in California as it does in Maine.)
Linking payment to value and then to price…that’s something the market can and must do.
The bad news — as Peter notes — is that Avastin and Erbitux will not be made available to colon cancer patients in the UK because it doesn’t really prolong life. That is also what NICE said about Taxol, Herceptin and Gleevec by the way, all of which have been shown to increase survival and prolong life. The good news is, since NICE will not cover Aricept or other drugs for Alzheimer’s people with AD and colon cancer won’t know they are being denied Avastin and Erbitux.
Meanwhile, Madonna has told the Blair government that it should use mystical waters to clean up radioactive pollution. According to the Times of London she and husband Guy Ritchie “have been lobbying the government and nuclear industry over a scheme to clean up radioactive waste with a supposedly magic Kabbalah fluid.” The plan, just recently revealed, hinged on a “mystical” liquid that she says neutralized the radiation in a Ukrainian lake. Madonna, who studies Kabbalah, insists that the stuff is for real. The better news? NICE has already approved it for reimbursement because it’s cheap.
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.
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.”
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.
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.
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.
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.)