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Genetic tests that will screen people to see if they are high responders will be used in combo with proteomic or metabolomic tests to develop optimal doses and imaging markers to determine best response. Such work is already going on in cancer and with such drugs as Avastin. More on that later.
Yesterday David Brailer, who leads the nation’s health IT efforts, announced he is stepping down from that post to spend more time with his family. Brailer has spent the last two years herding cats but also championing the need to get serious about investing in all forms of health IT. He helped created a vision and a critical mass as well as — dare I use the term — a tipping point towards the development of a framework in which health information becomes an important tool for improving health and preventing disease. We should thank him for a great job and for devoting his time and energy to public service.
From the Financial Times
According to the MIT Technology Review an international group of scientists has demonstrated a new tool for personalized medicine that makes it possible to predict nearly any adverse reaction an individual might have to drugs. Rather than being based on genetic screening, which up to now has been the dominant approach to personalized medicine, the new test relies on profiling an individual’s metabolic products.
Called pharmaco-metabonomics, the technique involves screening urine for metabolite: small molecules that are involved in or produced by the metabolic processes that sustain an organism.
Besides predicting adverse drug reactions, pharmaco-metabonomics also has the potential to determine more effective dose levels for each individual. “There is no genetic technique that can do that,” says Jeremy Nicholson of Imperial College London, the researcher who led the investigation.
Here’s a link to the complete article:
On Thursday, Medicare officials released new statistics showing that 8.1 million people are now enrolled in stand-alone Medicare prescription drug plans, an increase of 1.7 million in the past four weeks. More than 30 million of the nation’s nearly 43 million Medicare recipients now receive some assistance in paying for their medications.
“Strike up the Klezmer and start acting like a man. You’re about to have a Truth Mitzvah.” — Steven Colbert
According to a widely reported new paper, every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses.
Here we go again. God forbid we should have schizophrenics treated with medication.
The American Psychiatric Association, which publishes the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual — due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world.
And that’s as it should be. Disclosure and transparency are, as Martha would say, “good things.”
John Kane, an expert on schizophrenia who worked on the last edition, commented that, “It shouldn’t be assumed there is a true conflict of interest.” Kane said the report’s conclusions were driven only by science. “To me, a conflict of interest implies that someone’s judgment is going to be influenced by this relationship, and that is not necessarily the case.”
Indeed. I guess Citizen Kane didn’t get the memo that explains why, if you are in any way associated with the pharmaceutical industry, you are guilty of crimes against humanity even if you’re innocent. And if you’re innocent you’re naive and are being used by the industry for its nefarious purposes. Witness the headline in the Washington Post, “Experts Defining Mental Disorders Are Linked to Drug Firms.” Can you say “leading the witness?”
Steven Sharfstein, president of the American Psychiatric Association, said, “I am not surprised that the key people who participate have these kinds of relationships. They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship — but there should be full disclosure.”
You bet. Disclosure. Disclosure. Disclosure. But here’s the question phrased differently — Why does the pharmaceutical industry only do business with the smartest minds in medicine? Answer: Because they are the smartest minds in medicine.
The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said.
And, in the interest of transparency and disclosure, Mr. Krimsky is the author of the book “Science in the Private Interest,” so we certainly can guess at his general perspectives on the issue.
Should professional relationships be disclosed? Most certainly. Should the best minds in medicine be recused from sharing their wisdom? Certainly not.
Drugwonks.com is pleased to be part of a blogposium on Clinical Informatics, a neighborhood of folks with a passion to advance understanding on how bioinformatics and electronic patients records can improve health care. Jack Mason is the blogposium’s chair. He can be contacted at firstname.lastname@example.org.
Yesterday the CDC reported that life expectancy rose faster and death rates declined faster last year than in the past 30 because of new medicines. This bodes well for those getting the Medicare drug benefit in record numbers. But meanwhile Families USA wants to shove seniors into a VA style plan that limits access to these new medicines. Limiting access to new drugs and keeping them off formulary is a form of rationing and way to keeping formulary closed, ,which itself is a bargaining tool for driving down drug costs. In fact a study by Columbia University’s Frank Lichtenberg shows that the VA drug lag has actually increased death rates and reduced life expectancy among seniors. This is what is going on in the UK by the way where breakthrough by breakthrough the government is finding ways to say no to drugs for cancer, Alzheimer’s, MS and diabetes that increase life expectancy and quality of wellbeing. The justification of the VA and UK are similarly and depressingly striking. Actually studies show that limiting access drives up total costs and makes seniors sicker. Why would Families USA want that? Perhaps their hatred of drug companies outweighs their concern for the lives of seniors. Ron “The Godfather” Pollack the Don of Families USA wants everyone to believe that the VA just hands the off formulary medicines like candy after a friendly sort of negotation. Not so. Even the non-formulary drugs have to be discounted by at least 40 percent or you can’t get them. Getting on the formulary costs even more. So if you are biotech company that makes no money what incentive do you have to even try? No wonder the VA drug lag is growing and seniors are suffering as a result. Imagine if this little drill was applied to Medicare as a whole just like the Godfather wants?
Yesterday the UK’s National Institute of Clinical Excellence (which goes by its Orwellian acronym of NICE) rejected Exubera (inhaled insulin) for NHS use on the grounds that the drug isn’t “cost-effective.” That means they don’t want to pay for it — not because it doesn’t work or it isn’t an advance — but because, well, they just don’t want to pay the additional 10 pounds (about $17.83) per week for those patients who would prefer inhaling rather than injecting their insulin. NICE’s dismissal of resultant savings from enhanced compliance and decreased complications? Total.
Dr. Kate Lloyd, the UK medical director for Pfizer (Exubera is a Pfizer product) called the decision “perverse and short-sighted.” It’s refreshing to hear such a clear and unambiguous shot across the bow from a pharmaceutical company.
Kiss me Kate.
Not surprisingly Diabetes UK (the largest diabetes patient organization in Britain) is — no pun intended — up in arms. Says Simon O’Neill, their director of care and policy, “The government has put patient choice on the NHS agenda. Diabetes UK is disappointed that the (NICE) guidance on inhaled insulin does not reflect this as we believe it could offer an alternative treatment in improving the lives of some people with diabetes.”
To which Dr. Andrea Sutcliffe (NICE’s deputy chief executive) responds, “The clinical experts we asked advised us that using injected insulin is not usually a concern for the majority of people with diabetes.”
Well … what about a sizable minority? Once again we witness the victory of equality vs. quality — the hallmark of government-sponsored “universal health care.” If you believe in cost-based medicine (referred to most commonly in the US by the equally Orwellian moniker of “evidence-based medicine”), then this is what you get. And you better get used to it … or get involved in the debate.
Prime Minister Blair admits that Britain’s health care is at a “crunch point,” but insists that the UK is still on an historic “end to traditional waiting” by 2008.
Makes sense to me. Disallow all new treatments and I too would predict an historic end to waiting — as well as a permanent end to quality health care.
Let’s not allow what’s going on “over there” go unrecognized over here.
Here’s an editorial from the Rocky Mountain News. That fresh mountain air certainly produces some clear-headed thinking.
Don’t target ads in drug-buying bill
Bill has one good idea, and one very bad one
Is Senate Bill 1 right for Colorado? If it did nothing more than let the state join a purchasing pool that cuts Medicaid drug spending, we would be inclined to say yes.
But to again paraphrase the TV ads, SB 1 has some serious side effects. The most dangerous is an onerous disclosure provision that would force drug companies to spend money defending their advertising budgets rather than, say, producing life-saving treatments.
If the disclosure requirement remains in SB 1, which is scheduled for a Senate vote today, we urge Gov. Bill Owens to veto the bill should it ever reach his desk.
That would be an unfortunate necessity if proponents of SB 1 are right: They say the state could save $20 million of $170 million it is spending on Medicaid drugs this year.
That may be an exaggeration. State health officials suggest the savings would be more like $3 million to $4 million. Still, that’s real money.
Under the bill, the state department of health policy would join a purchasing pool with other states to buy drugs for Medicaid recipients. People who earn too much to get Medicaid (up to $50,000 for a four-person household) but do not have medical insurance or whose policies do not pay for prescriptions could join the pool for $25 a year and purchase drugs at the discounted rate.
We supported a somewhat similar bill last year that Owens vetoed. We oppose SB 1, however, because of its inexplicable disclosure requirements, which could have been written by Ralph Nader. Asserting that advertising and lobbying leads to “an inordinate and unnecessary escalation of the cost of prescription drugs to consumers,” the bill would force every pharmaceutical company to detail its marketing budget to the state.
Every year, each drug maker would have to list promotions directed toward “any physician, medical student, hospital, nursing home, pharmacist, health benefit plan,” etc. We’re guessing that would include an accounting for the pens pharmaceutical reps hand out to receptionists.
They would also have to report all gifts worth more than $50, and naturally, how much they spend on lobbying, and who got the money.
Why? The Naderite left has long claimed that recent advances in medical science are mainly an illusion. Instead, drug companies largely repackage similar formulations and use promotional gimmicks to hoodwink doctors into prescribing new medications their patients don’t need.
Tell that to the arthritis patient who lives a relatively normal life because she can take Celebrex rather than megadoses of aspirin, or the diabetes sufferer who can test his own blood sugar with a pocket monitor.
It’s the business of shareholders and corporate boards to decide how much money a company spends on promotion and marketing. Lawmakers and bureaucrats should butt out.
Besides, if drug makers were forced to satisfy elaborate disclosure mandates, that would divert their focus from healing people — which is why, in its current form, SB 1 offers the wrong diagnosis.
I gave out the wrong address to the new medical news media watch website… It is www.healthnewsreview.org I apologize for confusing people more than I usually do. Thanks to Antoine Clarke for picking up the boo-boo. The link to the Health news review rating of the CBS news treatment of the Evista study is posted below as is the review itself. As I noted in my last post, I think their review underscores the need for the oncology community to get on with the job of tailoring treatments according to how well people respond to certain cancer drugs. I have included an article that deals specifically with tamoxifen and other estrogen modifying agents and pharmacogenomics below.
This story reports on a potentially important development in the prevention of breast cancer among high risk, postmenopausal women.
The story is clear that this is an existing drug for osteoporosis that has not been approved by the FDA for use in breast cancer prevention. The story also does not make claims about when it may be approved for that purpose. There is no obvious disease mongering; the story accurately represents the prevalence and seriousness of breast cancer
Although there is mention of a clinical trial, the story does not describe the study design. Also not mentioned was the fact that the results have not yet been published or peer reviewed, so interpretation of the clinical significance of these results are difficult at this time. Benefits of treatment are quantified in relative terms only. The viewer is told that raloxifene and tamoxifen both reduce the incidence of breast cancer by about 50%, however there is no context provided for these numbers. Most viewers would want to know “50% of what?” They want the absolute risk reduction. Viewers should have been told that even though the women in the study were high risk, the incidence of breast cancer over 5 years was still very low. The story also does not mention that raloxifene does not reduce the incidence of ductal carcinoma in situ (DCIS, which tamoxifen does), so it is not clear that when the story says the benefits are equivalent between the two drugs, if it will hold true if they include all breast cancer events (including DCIS, which is found quite commonly these days).
The story also omits an important fact: the decrease in incidence of uterine cancer and clots in the raloxifene group was not statistically different from the tamoxifen group. Although uterine cancer and blood clots are mentioned as harms of treatment, there is no mention of how often they occur. Other harms such as cataracts and stroke are not mentioned.
No costs are mentioned. According to the website for the STAR trial, the cost of Raloxifene is about $75 per month, while Tamoxifen costs about $100 per month. Because these drugs have to be taken for long periods of time, cost is an important issue.