Latest Drugwonks' Blog

Taylor Made

  • 11.27.2006
In a new report from London's School of Pharmacy, Professor David Taylor (a contributor to the new CMPI/CNE book “Coincidence or Crisis”) points out: "The present system encourages traders to buy modern medicines cheaply in parts of Europe where governments impose low prices, and sell them on in new packages in EU member states where government controlled prices are higher. People think this saves money. But the evidence explored in our report indicates that it is in fact undermining European economic interests and may, on occasions, have created a pharmacy culture that increases counterfeit medicine hazards."

The report calls for stronger legal penalties for medicine counterfeiting and say they also support reform in other areas, from greater freedom of regulated medicines information provision in Europe to better controls over internet pharmacy and medicines trading. Importantly, the School of Pharmacy backs a strong patent system to fund medicines research and says without assets such as the research-based pharmaceutical industry "Europe's economic future will be bleak."

If you would like a copy of "Coincidence or Crisis," please send an email to ppitts@cmpi.org.
Here's a great example of how medicine and the private sector are transitioning to prospective and personalized care...with BG Medicine (called Beyond Genomics in this article) a company that was involved in the FDA task force I chaired when I was at the Manhattan Institute, helping build the foundation with bioinformatics...


Drug and device firms invest in study of plaque to find trigger for heart attacks (11-26-06)

The International Herald Tribune


New York, 11/27/2006 - Most people have a clear image of how atherosclerosis, popularly known as hardening of the arteries, causes a heart attack: fatty deposits called plaque build up in a coronary artery until the day the blood flow that sustains the heart is blocked.

If only they were right. In reality, coronary artery blockages almost always cause chest pain known as angina and other symptoms as they form. But half of the men and two-thirds of the women who suffer heart attacks never experience warning symptoms.

And autopsies of such victims frequently show blood clots jammed into arteries that have been only modestly narrowed.

Standard atherosclerosis therapies include bypass surgery to route blood around blockages, angioplasty and stenting to clear blockages from inside the artery and drugs like statins that reduce cholesterol levels to slow the formation of plaque. But they have not been enough to prevent as many as 500,000 deaths a year in the United States alone from what doctors call coronary artery disease.

As a result, many researchers have turned their attention from atherosclerosis in general to the tendency of some patients to develop a form of plaque prone to inflammation and rupture, which can spill a stew of cells into the bloodstream that can incite rapid clotting.

Such plaques have been called "vulnerable" plaque." But little is known about how such plaques form and even less about how long they last or what makes them rupture.

"Figuring out who is going to have plaque rupture would be the Holy Grail of cardiology," said Deepak Bhatt, a leading research cardiologist at the Cleveland Clinic Foundation.

The broadest effort yet to do that was to be announced Monday by a consortium pledging to invest $30 million over the next four years in an international plaque research program that will be overseen by Valentin Fuster, a cardiologist at Mount Sinai Medical Center in New York.

The initial sponsors include Humana, a leading manager of health plans; AstraZeneca and Merck, from the drug industry; Philips Electronics, which makes diagnostic machines widely used to scan the heart, the arteries that supply it with blood and other parts of the circulatory system; and BG Medicine, a start-up in Waltham, Massachusetts, formerly known as Beyond Genomics.

The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope that the profiles that emerge from the study will show patterns pointing to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create therapeutic products.

The payoff could be enormous for health care companies. Coronary stents, which limit the symptoms of atherosclerosis and the damage from heart attacks, but do not reduce the likelihood of future attacks, make up a $6 billion market for device makers and produce some of the biggest profit margins the industry has ever seen.

Drug makers have fared even better with statins, which partially reduce the risk of new attacks and top $20 billion in worldwide sales.

"How we treat the disease is up for grabs," said Andrew Plump, who monitors early-stage research on new cardiovascular medicines at Merck's research center in Rahway, New Jersey.

The initiative spotlights the growing lineup of research projects and technology investments that reflect competition between drug makers and device companies to develop the safest, most effective and cheapest products to combat atherosclerosis.
According to a WSJ.com/Harris Interactive health-care poll U.S. adults are divided on whether doctors should be allowed to prescribe drugs to treat diseases or conditions other than those for which they have been approved.

45% of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.

Frighteningly, nearly two-thirds say they would agree to prohibit off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations. Attention must be paid – this is the slippery slope that the Apostles of Evidence-based Medicine would have us follow – to disastrous consequences.

Fortunately, when put into the appropriate perspective, Americans don't want to hamper innovation. 55% believe that if doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases vs. 35% who disagree.

More than two-thirds believe drug companies shouldn't be “allowed to encourage” off-label use vs. 12% who disagree and 20% who aren't sure. Perhaps a better way to have framed that question would have been to have asked if drug companies should be “allowed to share valid clinical information” about off-label use?

One wonders if the pollsters screened out as respondents patients with cancer, multiple sclerosis, etc. and their family members. And, if not, how that segment answered the questions.

For that we do not need a research project – we need a robust Critical Path program.
"The newly empowered Democrats' vow to cut healthcare costs might spell bad news for the brand-name pharmaceutical industry, but could provide new momentum for generic drug rivals, the Wall Street Journal reported on its Web site on Tuesday. "

.How could more competition be bad? Unless of course Dems want to protect generic companies from competition in the process,.,,If the GOP is smart, they will respond with measures to accelerate and encourage development of new drugs too -- as well as protect authorized generics -- since new drugs are the source of generic profits in the final analysis and authorized generics ultimately promote more price competition!
I was in Montreal yesterday giving a lecture on why ideas -- and not just politics -- matter in health care. On my way to the hotel where the conference was being held I saw the headline of the Canada's newspaper of record, The Toronto Globe and Mail. In bold type, across the entire width of Page One was the headline:

Vow Broken on Cancer Wait Times

"It was a bold promise backed by billions of dollars in new government funding: Cancer patients should not have to wait longer than four weeks to obtain critical radiation treatment."

"Four weeks. That's double the maximum waiting time oncologists recommend but still seemingly better than the cancer-care limbo many patients faced when Liberal health minister Ujjal Dosanjh and his provincial counterparts made the announcement last December."

"But figures obtained by The Globe and Mail show a staggering 70% of Canadian hospitals surveyed are unable to meet that standard for prostate cancer patients."

You get the picture?

And yesterday was only the most recent installment of a weeklong series on how the Canadian health care system is failing cancer patients.

Today's headline reads:

Provincial drug disparity a roadblock to cancer research

"For the first time, Canada is unable to participate in a key clinical cancer trial because patients are not getting the best known treatment."

"Since most provinces don't fund Avastin, a crucial drug in the fight against colorectal cancer, Canadian patients could not join a trial run by the National Cancer Institute in the United States, which is studying what drug is most effective with chemotherapy — Avastin or Erbitux — or if they work best given together."

Please pass along this important and devastating series to anyone who recommends that what we need in the US is a system "just like Canada."

Here's a link to the series:

http://www.theglobeandmail.com/cancer

It's a worthwhile, disturbing read.
What can you get for four bucks these days? Cheese in a spray can? Cinnamon dental floss?

How about a month's supply of life-saving prescription drugs?

Have a look at this new op-ed in today's edition of The Baltimore Sun:

http://www.baltimoresun.com/news/opinion/oped/bal-op.walmart22nov22,0,6905737.story?coll=bal-oped-headlines



And have a very happy Thanksgiving.
New Hearing for Suit Against FDA
Associated Press

A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.

The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.

The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.

In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.

The FDA, in turn, appealed and asked for the full court to rehear the case.
Yesterday the New York Times published a few letters pertaining to the issue of Medicare reform and specifically the issue of non-interference.

My letter, alas, was not chosen. (My mother-in-law was very upset.)

Here is what I wrote:

To the Editor:

Your editorial (Lowering Medicare Drug Prices, November 14, 2006) suggests that the Veteran’s Administration “negotiates” prices for prescription drugs. Not so, it mandates them – and that’s more than a rhetorical finesse.

Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.

A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.

There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.

Sincerely,

Peter J. Pitts
Center for Medicine in the Public Interest
Health Affairs is running a study showing that most seniors have a coverage gap...what is left out or unstated or misconstrued is that fact that most seniors have chosen to have a coverage gap....Here is what the study notes but fails to highlight...

“United’s AARP product leverages beneficiaries’ recognition of the AARP ‘brand’,” while “Humana attracted high enrollment in its Standard PDP with an aggressive low-premium strategy.”

In otherwords, people are choosing coverage based on values that matter to them, not what matters to elites. That was the point of competition. Also unstated is the fact that copays in the plans with most customers have declined as have the price of drugs outside the coverage period. That is also in response to demand.

How soon people forget that consumers, not policy elites, are in the drivers' seat here. Will people like it if the elites rob them of their choce o f plans, deductibles and drugs to satisfy elite concerns about "coverage"?

I don't think so...
This is my next to last post from Israel....

Since everyone who supports the government getting into the business of compraing the effectiveness of drugs have assured me that the methodological issues are quite easy to address I am announcing a pre-Thanksgiving comparative effectiveness contest to come up a way of establishing the comparative effectiveness of using different cancer drugs with the technological advance described in this article:

Toward Reducing The Toxic Side Effects Of Cancer Chemotherapy
An advance that may speed the use of "prodrug chemotherapy" -- one of the most promising new strategies for reducing the side effects of anti-cancer drugs -- is being reported by scientists from Johns Hopkins University's In Vivo Cellular and


This two-part chemotherapy involves giving patients the inactive form of an anti-cancer drug (the "prodrug") and an enzyme that changes the prodrug into an active, cancer fighting form. Patients first get the enzyme, which is gradually eliminated from normal tissue but builds up and remains in the tumor. Then patients get the prodrug, which changes into its active and toxic form only upon encountering the enzyme in the tumor.

"Determining the optimal time-window for prodrug injection is therefore of utmost importance for success of these strategies," Zaver M. Bhujwalla, lead author Cong Li and their colleagues note in a report scheduled for the Nov. 29 issue of the weekly Journal of the American Chemical Society.

If the prodrug were injected before all the enzyme cleared from normal tissue, it could damage normal tissue and cause body-wide side effects, they say.
The report describes the synthesis and early laboratory testing of the first prodrug-activating enzyme that can be imaged in tissue to time administration of the prodrug. The enzyme produces the active form of the common anti-cancer drug 5-fluorouracil. Its elimination from normal tissue can be monitored with magnetic resonance imaging (MRI) or optical imaging, according to the researchers."


Anyone want to come up with a method of comparing the effectiveness of delivering 5-F with side effects and without that a) does not delay access to new technologie, b) captures individual response to pro-drug injection since that will be key to optimal treatment and c) determine whether alternative drugs delivered in pro-drug or non-pro-drug fashion are the best for a particular cancer at a particular state? And extra credit for figuring out a way to continually add new drugs and new approaches in real time as opposed to when it is convenient for bureaucrats and politiciians

The comparative effectiveness crowd wants to spend a billion a year on this approach as a cure all for drug costs and a filter for setting up drug formularies AND it will be proposed as a way to set government prices for breakthrough drugs.. A Dunkin Donuts coupon for the winner of contest....We promise to post the results and responses...


Bonus question

Come up with a comparative effectiveness method for evaluatng the folowing advance:

Nanoparticle-Arsenic Combination Makes for More Potent Anticancer Agent
Arsenic trioxide, one of most promising drugs for treating acute
promyelocytic leukemia, encapsulated in lipid-based nanoparticles
designed to release their cargo inside tumor cells.
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.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog