The Part D Hasn't Started Yet

01/05/2007 12:59 PM |

The two page bill (more like a placeholder) is just the first step designed not to step on the toes or in front of the cameras of those committee chairs who are inclined and will be likely to introduce much more draconian measures. To be sure the D's don't want to do anything to undermine the large but extremely soft numbers in support of "direct negotiations" which is why they came up with poll-tested and politically ambiguous piece of legislation ("nothing in this act should be construed as requiring the Secretary to wear a dress to work every morning, especially with white shoes, especially when not in season..")

I wonder what the poll numbers would be like if the pollsters asked intelligent questions like: Do you support government negotiating directly with drug companies even if it might result in restricting access to new medicines and less money for stem cell research?

I wonder.  Read More & Comment...

Madam to Madam

01/05/2007 08:47 AM |

And only in the nicest meaning of the term!

Here's an important new op-ed piece by Madam Grace-Marie Turner of the Galen Institute addressed to our new Madam Speaker. Topic: Medicare and the Part D benefit.

http://www.chron.com/disp/story.mpl/editorial/outlook/4447256.html

We're sure that Grace-Marie's advice is offered in the spirit of partnership rather than partisanship.  Read More & Comment...

Wither Internet Pharmacies

01/05/2007 08:14 AM |

Here's another take on the "sleazy side" of Internet pharmacies:

http://www.cmpi.org/newsDetail.asp?contentdetailid=259&contenttypeid=3&page=1

Worth a read.

Final quote in the article says it all, "Rogue outfits wouldn't keep operating if they weren't profitable. Legitimate pharmacies are licensed for a reason. Sometimes a bargain is just too expensive."  Read More & Comment...

Goodbye Non-Interference. Hello Con-Interference.

01/04/2007 03:48 PM |

Courtesy of Mr. Dingell and Mr. Rangel, please welcome the “Medicare Prescription Price Negotiation Act of 2007.”

Goodbye non-interference. Hello con-interference.

And if the devil is in the details this bill is as saintly as they come because, there ain’t no details – the bill runs just a tad over two whole pages, double spaced. Talk about Part D Deficit Disorder.

The good news/bad news is that there’s no there there.

Good news because there’s no there there.

Bad news because it is the beginning of the slippery slope towards choice controls (aka: price controls). And, because of that, it must be robustly fought.

According to the draft bill, “… the Secretary shall negotiate with pharmaceutical manufacturers the prices that may be charged for covered part D drugs for part D eligible individuals,” but “nothing shall be construed to authorize the Secretary to establish or require a particular formulary” and “… shall not be construed as affecting the Secretary’s authority to ensure appropriate and adequate access to covered part D drugs under prescription drug plans …”

So, the Feds can negotiate, but if the negotiations fail (whatever that means), the Secretary doesn’t have the authority to “ban” any drug from any federally-funded formulary (i.e., every single existing part D plan). Some hammer.

And, to remove yet another tooth, the bill makes clear that "government prices” need not even be the lowest ones. As the draft bill reads, “Nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan, or an organization offering an MA-PD plan, from obtaining a discount or reduction of the price for a covered part D drug below the price negotiated under paragraph (1)” – the “government price.”

A total toothless wonder – and no wonder. The new Congressional majority knows how to read a poll. Seniors like the prescription drug benefit. It works. It’s an entitlement – the newest political third rail.

This bill is a dodge. A face-saver. And it’s dishonest from every angle. For those who believe in real price controls (Rahm Emanuel, etc.) it’s a teensy-weensy baby step. Such folks (however wrong-minded) should be outraged at such a lame piece of legislation. For those opposed, it might very well be seen as an easy “yea” vote – since it really won’t do anything. But, as stated above – it’s a slippery slope with the slippery folks at the helm for the time being. "Least worst" alternatives must not acceptable when it comes to the public health.

Here is a link to the draft legislation:

Download file

See if you can read it in its entirely while holding your breath. And then take a deep breath – because the battle has begun.  Read More & Comment...

CMPI Science Adviser Launches Personalized Medicine Breakthrough

01/04/2007 01:27 PM |

So much for the one size fits all formulary plans of Marcia (one drug per disease will do ya) Angell and those in the EBM movement.....


Dr. Gualberto Ruano, President of Genomas, Inc. and a principal scientific adviser to The Center for Medicine in the Public Interest has identified DNA markers for risk and protective factors involved in diabetes-related metabolic side effects from treatment with common antipsychotic drugs used to treat schizophrenia and manic depression.

The research, which was published in the January 2, 2007 online issue of Nature Publishing Group’s Molecular Psychiatry, highlights how understanding a patient’s DNA can predict an individual’s profile of risk or protection from the antipsychotic drugs prescribed, and paves the way for using genetic tests to personalize the treatment of mental illness. The study, entitled “Physiogenomic comparison of weight profiles of olanzapine- and risperidone-treated patients”, looked at two of the leading atypical antipsychotic medicines on the market and found that a series of unique DNA variations could predict a patient’s likelihood for developing pre-diabetic side effects such as weight gain.

The use of antipsychotic drugs is on the rise, with an estimated 14 million patients suffering from chronic mental health disorders -- such as schizophrenia, bipolar disorder, obsessive-compulsive disorder, and generalized anxiety disorder -- for which these drugs are increasingly being prescribed. Atypical antispychotics (AAPs) can induce diabetic symptoms in nearly one third of patients, most notably characterized by increased weight gain in some patients but not in others. However, the side effect profiles for these drugs even within the same drug class may differ, raising the possibility of drug-specific side effects.

Dr. Ruano's research demonstrates that risk varies by individual and can be predicted and limited in ways to offer hope and reduce suffering. His research and dedication to the making medicine more predictive underscores the immense opportunity of personalized medicine as well as the human price we will pay if policymakers persist in imposing one size fits all solutions on patients and the public as a whole.

CMPI plans to conduct a study to determine the value of widespread DNA testing for AAPs in terms of the time and money saved by avoiding unnecessary, ineffective of unsafe treatments.

The battle is joined. And Dr. Ruano will be joining us at our Media and Medical Science conference in DC on Feb 21.  Read More & Comment...

Learning Abbott's Lesson on Drug Pricing

01/04/2007 12:08 PM |

It is not for nothing that the WSJ ran its piece on Abbott's strategery regarding the re-pricing upward of Norvir the week that Democrats are planning to push through price controls on prescription drugs. (See New Regimen Inside Abbott's Tactics To Protect AIDS Drug Older Pill's Price Hike Helps Sales of Flagship; A Probe in Illinois By JOHN CARREYROU)

But then again, the article does offer some valuable lessons from drug and biotech firms as does a seemingly unrelated article by Alan Murray today dealing with the demise of Home Depot's CEO Bob Nardelli for not understanding that today's corporate chieftain is now in charge of a group of stakeholders (that's why it's called a public company) and not just the bottom line. Indeed, it is the persistent failure of drug and biotech companies to fail to plan for the political and consumer impact of it's corporate decisions.

Abbott raised the price of Norvir when it became clear it was being used as a booster for a competitor product. But the company did a horrible job of clearing the path for what it knew would be a controversial move. In the end, the furor died down but not until Abbott took steps it should have integrated at the outset into an overall package to both explain and insure that both Norvir and it's new product, Kaletra, could be used a suite of products en route to delivering outstanding care. Abbott undertook damage control when it should be been planning for a reconfiguration and relaunch, working and talking to the groups affected and interested in its products.

The fact is what drug and biotech companies do interest people far beyond the immediate group of patients and clinicians that use them. They generate headlines for news organizations and politicians alike. Companies have yet to understand that public policy is just as important to the launch and reimbursement of a product as the science behind it. Similarly, CEOs in the industry seem to be the last of the bunch to understand that their role is not just making the numbers and steering firms through a transition in the science of drug discovery, tough as those tasks are.

Rather, as Alan Murray notes about Home Depot's Bob Nardelli can still be said for many CEOs in the pharma and biotech community:

What Mr. Nardelli missed, however, is that in the post-Enron world, CEOs have been forced to respond to a widening array of shareholder advocates, hedge funds, private-equity deal makers, legislators, regulators, attorneys general, nongovernmental organizations and countless others who want a say in how public companies manage their affairs. Today's CEO, in effect, has to play the role of a politician, answering to varied constituents. And it's in that role that Mr. Nardelli failed most spectacularly.' See Alan Murray's article: Executive's Fatal Flaw:
Failing to Understand New Demands on CEOs in today's WSJ.

The Abbott article is a cautionary tale of the cost of continuing to fail. As we enter a high dry political season for pharma-bio, leadership on a grander scale will be required. Above all, if CEOs fail to defend the mission and value of their enteprise, no one else well. Ultimately, the pharma CEO must create a constituency for his corporation. And simply paying lobbyists to keep the wolves away will not do.  Read More & Comment...

Not quite, but almost (Freking) perfect

01/04/2007 11:49 AM |

In case you missed.

(Of particular interest is that the Part D provider having the biggest problems -- at least according to one pharmacist -- is the AARP.)

Medicare drug benefit signup less bumpy this year
By Kevin Freking
ASSOCIATED PRESS

WASHINGTON – Seniors are experiencing fewer problems at the start of the Medicare drug benefit's second year, even as hundreds of thousands come into the program for the first time or change plans.

The smoother start was reported Wednesday by federal health officials and representatives of seniors and pharmacists.

“It's not perfect, but it seems a lot better than last year,” said Carol Cooke, spokeswoman for the National Community Pharmacists Association, which represents about 24,000 pharmacies.

“It's nothing overwhelming like last year,” said Deane Beebe of the Medicare Rights Center. “But, yes, there is a smattering of problems we're hearing about. We've also spoken with pharmacists who say it's too soon to tell.”

With the start of a new year, hundreds of thousands of people are coming into the program for the first time, while hundreds of thousands more have switched insurance plans. The changes have the potential of causing havoc for consumers and health care providers if they weren't properly plugged into computer databases before Jan. 1.

The Centers for Medicare and Medicaid Services said it had seen nothing like the barrage of complaints that had marked the drug program's first week in 2006, when consumers were not listed in insurers' databases and pharmacists had problems verifying coverage.

“It's very quiet, but we're always on the lookout. There's nothing that has risen to the level of crisis,” said Jeff Nelligan, spokesman for the agency, which oversees the drug benefit. Cooke said pharmacists had reported problems billing UnitedHealthCare, which administers drug plans with the AARP brand and has the highest enrollment. She read an e-mail from a pharmacist: “It is now 1 a.m. and I am still at work since 9 a.m. transmitting claims for Part D. During the day, I could get no AARP claims to go through.”

“We had initial issues that affected our systems, but at the present time, we are seeing high service levels and 99 percent of all claims submitted are being processed within one second,” replied Peter Ashkenaz, a spokesman for UnitedHealthCare.

Last year, Cooke and her colleagues returned from the New Year's holiday to find their telephone message systems overflowing with complaints.

Under the program, beneficiaries can choose from 50-plus plans serving their states. They pay a monthly premium and for some of the costs of their medicine. The federal government picks up most of the initial expense. But once total drug costs reach $2,400, there is a gap in coverage – the so-called “doughnut hole” when the plan will pay nothing toward the cost of the drugs. That gap continues until total drug costs total $5,451. Then, the government begins paying again at a rate of 95 percent.

The poor get extra help with the cost of their medicine.

About 23 million people are enrolled in drug plans. People could switch plans or enroll for the first time from Nov. 15 through Dec. 31. Deadline exceptions will be allowed for some seniors, particularly about 250,000 people enrolled in plans that failed to properly notify them of changes in their coverage. The federal government gave them another six weeks to make a switch if they want.

Going into the new year, federal officials were most worried about those seniors who waited until the final few days to change plans. However, surveys indicated that few seniors would do so. The Kaiser Family Foundation polled seniors in early November about whether they would change drug plans. Only 5 percent said yes. About 66 percent said no. The remainder said they had yet to make that determination.

Beebe said a federal mandate that insurers provide an emergency 30-day supply of medicine has helped limit problems. She also said that some consumers learned from last year. They filled their prescriptions just before the end of 2006 so that they wouldn't have to deal with problems that they encountered last January.  Read More & Comment...

A Sweet Solution to Democratic Attacks on Part D

01/04/2007 11:38 AM |

Hybrid Molecule Causes Cancer Cells To Self-destruct
Science Daily — By joining a sugar to a short-chain fatty acid compound, Johns Hopkins researchers have developed a two-pronged molecular weapon that kills cancer cells in lab tests. The researchers cautioned that their double-punch molecule, described in the December issue of the journal Chemistry & Biology, has not yet been tested on animals or humans. Nevertheless, they believe it represents a promising new strategy for fighting the deadly disease.

Could we link a sugar to Pelosi's price control plan for seniors and get the same therapeutic explosion. Heck, I would even support Byron Dorgan in opposing stuffed molasses in from Canada at a lower price for that to happen... apparently the Senator who supports using price controls from Canada on medicines opposes reimportation of stuffed molasses from the same country to get around sugar tariffs imposed on behalf of sugar producers in the US, particularly in Lousiana, home of Senator David Vitter who courageously blocked a vote to confirm Andy von Eschenbach in order to bar customs officials from seizing counterfeit drugs at the Canadian border.  Read More & Comment...

When VA means STOP

01/04/2007 08:43 AM |

CMPI's Dr. Bob Goldberg, as quoted in today's Wall Streeet Journal Review and Outlook editorial:

The need for scrutiny is even more compelling on price controls for Medicare prescription drugs. Under the Medicare Part D benefit that took effect last year, private companies negotiate prices. Democrats want to allow the government to deal directly with drug companies. They argue that this would lead to lower prices for medicines, but the more likely outcome is fewer drug choices and price controls.

Democrats point to the Department of Veteran Affairs as a model, but we doubt seniors will like that story when they learn about it. The government already negotiates drug prices directly with the VA. But as Robert Goldberg wrote last month in the Weekly Standard, "Far from negotiating prices, the VA imposes them. Federal law requires companies to sell to the VA at 24% below wholesale price. If they won't, they are banned from selling medicines to Medicaid, Medicare and the public health service."

The VA has created a list of approved drugs for its patients. Companies that don't pay the VA price don't make the list, and a slew of drugs fall into that category. They include Azilect and Tysabri, two of the newest therapies for Parkinson's and multiple sclerosis, respectively. That's what happens when keeping prices down takes priority over getting the best available medicines to patients. Both drugs are available through Medicare Part D, by the way. Maybe Congress ought to debate this.  Read More & Comment...

Wood Eye!

01/04/2007 07:00 AM |

You know the joke.

The other joke is how Senators can be for unfair trade practices (like "drugs from Canada") one day, and against them (like, for example, "lumber from Canada") the next . The difference? You guessed it -- politics.

Many thanks to the drugwonks reader who sent in the following US Senate "colloquy" between Senators Baucus and Crapo. Here's how you play: Whenever you see the words "Canadian lumber," replace them with "Canadian drugs."

(And if you'd like more Senatorial Inconsistencies, check out Senator Byron "Mr. Importation" Dorgan's statements on Canadian wheat.) Talk about Washington DC log rolling!


CANADIAN SOFTWOOD LUMBER DISPUTE -- (Senate - January 24, 2005)

Mr. CRAIG. Mr. President, I rise today to discuss the latest developments regarding the Canadian softwood lumber dispute. With yet another curious and ultimately inconsequential lumber unfair trade determination due today at the behest of a NAFTA dispute panel, it is important to place this matter in proper perspective.

Would the distinguished Senator from Montana and my colleague from Idaho engage in a colloquy with me concerning the Canadian softwood lumber dispute?

Mr. BAUCUS. I would be pleased to engage in such a colloquy.

Mr. CRAPO. I would also like to join my colleagues in a colloquy on this matter.

Mr. CRAIG. The Commerce Department has found repeatedly that Canadian lumber is subsidized and dumped. World Trade Organization and NAFTA dispute settlement panels have definitively rejected Canada's long-time arguments that its underpricing of timber cannot be deemed a subsidy. The panels have also upheld findings that Canadian lumber is unfairly dumped in the U.S. market. The International Trade Commission has found repeatedly that the unfair imports threaten our industry with harm.

President Bush was well prepared to answer the Canadian Prime Minister when they last met. The President told the Prime Minister that the problem of subsidies and dumping is caused by Canada, and the solution lies with Canada, unless Canada wants the solution to be permanent duties to offset the subsidies and the dumping. In over two decades, Canadian officials have not gotten the message, at least not in a way that takes, that this problem will not be resolved by Canada's investing hundreds of millions of dollars in legal fees on more than 30 Washington law firms to circumvent U.S. laws in countless appeals to the WTO, to NAFTA panels and to the U.S. courts--several more were filed just this month. And it will not be solved by the cottage industry that has grown up in Canada to mount PR campaigns in the United States.

The U.S. timber industry vigorously supports the administration's view that the unfair Canadian lumber problem could most appropriately and productively be resolved through negotiations--although perhaps there just ought to be permanent duties in place. But the U.S. timber industry is taking the statesmanlike high road, and I support it. Some vested interests in Canada do not see this, and prefer endless litigation, probably based on misguided advice that this will be productive from those who have made a living defending Canadian subsidies.

Mr. CRAPO. Specifically, the problem remains that the market is grossly distorted by Canadian unfair trade practices. Absent termination of or an offset to the unfair practices, the U.S. timber industry will be severely impacted by subsidized and dumped Canadian imports. We in the Congress have been assured that those responsible in the administration will not allow this further injury to our industry occur.

A solution can be either border measures imposed by the United States or Canadian border measures agreed to with the United States pending adequate Canadian timber policy reforms.

The Bush administration has concluded that the November 2004 determination of the International Trade Commission that Canadian imports threaten the U.S. industry with injury--the ``Section 129'' determination--represents an independent basis authorizing and necessitating retention of the countervailing and antidumping duty orders. The United States has faith in winning the NAFTA Extraordinary Challenge Committee proceeding on the injury issue, but even a negative outcome before the committee would not be the end of the matter.

The Bush administration has concluded that duty deposits, amounting to approximately $3 billion and growing daily, cannot and will not be returned absent a negotiated settlement between the Canadian and U.S. Governments. The panels can provide prospective but not retroactive relief. In any event, these funds are rightly due under U.S. law to the injured domestic timber industry. If there is a negotiated solution, the funds can be apportioned fairly as part of the settlement.

There is zero likelihood that the countervailing duty, antisubsidy, order will disappear absent settlement of the lumber subsidy and dumping issues, no matter how often a NAFTA panel tries to achieve this outcome.

The U.S. right to challenge Canadian log export restrictions at the WTO is clear under the WTO, and Canada is clearly in violation of its WTO obligations. I understand that the Bush administration is evaluating this issue.

I also understand that the U.S. timber industry intends to bring a constitutional challenge to NAFTA dispute settlement if the lumber dumping issue is not resolved. The future of U.S. sawmills and millworkers cannot be allowed to be ruined by outlandish decisionmaking by NAFTA dispute panels and a panelist's service with an obvious, undisclosed conflict of interest.

Mr. BAUCUS. I agree completely with my colleagues. As suggested, a NAFTA dispute panel is requiring that the Commerce Department issue today yet another revised version of the original 2002 lumber-subsidy determination. Given the panel's pattern of overreaching, it may be a relatively low subsidy estimate. If so, this will be trumpeted in headlines across Canada as a victory for Canada's lumber policies. Before all those editorial writers seize on this supposed ``victory,'' they should understand that this determination will have absolutely no legal effect. It is the Commerce Department's December 2004 findings of a subsidy of over 17 percent and dumping of 4 percent that controls. Hyping the January 24 decision as having any meaning performs a disservice to Canadian interests, which lie in a mutually beneficial negotiated settlement.

Nothing can change the facts. The Canadian provinces provide timber to their lumber companies for a fraction of its value. This harms not only U.S. sawmills, millworkers and family forest landowners, but also the Canadian forest. Environmental groups have long decried the overharvesting of timber caused by undervaluing the resource.  Read More & Comment...

Paying for Drugs Twice...Yeah Right

01/03/2007 09:38 PM |

I am so tired of people claiming we pay for drugs twice. A quick look at the grants given out by NIH to investigators in academic researchers demonstrates that the money is given to pre-clinical activities. The track record of academics moving something into clinic is quite poor for a variety of reasons that have much to do with with quality of the translational research. That's where venture capital, biotech, and pharma comes in. And indeed without such investment -- which comes earlier than ever before in the discovery process -- taxpayer support for NIH would not be worth the effort. It's the private investment -- which by the way is now increasingly translational in nature and now involves the development of new drug development tools -- that enhances the NIH investment. Without the private sector we would not have any drugs to pay for at all.

Indeed, without contracts and contracting out in key areas such as genomics, proteomics, high throughput screening, biomarker development, the NIH would not be relevant. It needs and has relied upon constant collaboration with the private sector at all levels. In fact, efforts to bar NIH scientists from consulting and working with private companies has lead to a massive exodus of key researchers to for profit companies where there is more freedom and resources.

The point is, making medicine more altruistic will only make the NIH less vibrant and reduce the number of new drugs.

I wish people would grow up. Things worth having are worth paying for.  Read More & Comment...

Daddy, where do drugs come from?

01/03/2007 04:38 PM |

Per my most recent post (“Reference Pricing without the Reference”), a couple of readers have commented that Americans are “paying for drugs twice” – meaning that we pay taxes that go towards medical research and then pay for the drugs we purchase on top of that. Well, not so fast. Please note that only about 3 percent of drugs brought to market have significant involvement by government researchers.  Read More & Comment...

Reference Pricing without the Reference

01/03/2007 09:45 AM |

U.S. Representative (“Mr. Television”) Rahm Emanuel (D-IL) has announced that he will offer legislation aimed at “driving down the price of prescription drugs.” The only thing such legislation would accomplish would be the “driving down” of pharmaceutical innovation.

The NewSpeak-named “Pharmaceutical Market Access and Drug Safety Act, will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME). What else do these legislators have in common? That’s right – they’ve all been calling for the legalization of drug importation. And since the American public has accepted (albeit reluctantly) the many hard facts that explain why importation is neither safe nor effective, these fine members of the United States Congress have moved on to another simplistic and unworkable scheme.

According to Emanuel, et al., this legislation will “allow American consumers, pharmacists and wholesalers access to Food and Drug Administration (FDA)-approved prescription drugs at world market prices.”

Mr. Emanuel and crew may come from different states, but they are all firmly in residence on Fantasy Island if they think, with the stroke of a pen, “world prices” can become “American prices.” Are there world prices for hotel rooms or airplane tickets? What about Big Macs or automobiles? Of course not. In fact, there isn’t a world price for anything – except perhaps a barrel of oil. And we all know how well that’s working out.

Perhaps what Mr. Emanuel’s Frustrated Four mean is that the US should mandate what is known as “reference pricing,” a system that compares the prices of drugs among a number of developed nations and then chooses an “average” or “reference” price. This is what’s done in the European Union and Canada for example.

That sounds fair, right? Well, not really when you consider that the reason these nations can get away with reference pricing is because they threaten pharmaceutical companies with patent expropriation is they don’t knuckle under to these dictated terms. So while these nations all say that prices are “negotiated” with pharmaceutical firms, that’s just not so. It’s not even a take-it-or-leave it proposition. It’s a take-it-or we’ll-take-it-from-you shake down.

So couldn’t we do that too? If the Europeans and Canadians can dictate prices why shouldn’t we do the same? The answer is that we cannot and should not and here’s why – the prices Americans pay for medicines fuel global research and development. Those nations with reference pricing schemes are getting if not a free ride, then a highly subsidized one on the backs of the American health care consumer. That’s not fair, and it’s not just, and it’s not sustainable – but it’s a fact. And they don’t even say “thank you.”

So what would happen if we Rahm through “world pricing?” 21st century pharmaceutical research and redevelopment would grind to a halt for lack of dollars to fund it. Just last month the Government Accountability Office reported that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

What Mr. Emanuel and friends don’t seem to understand is that 21st drug development is ever more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome. Here’s a fact that you won’t find out from The New Man from Illinois – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.

Are you willing to trade tomorrow’s new cures and treatments for “world prices” today?

Because that’s precisely what will happen if we allow “world prices” for prescription medicines to be Rahmed down our throats.  Read More & Comment...

The Hidden Cost of Cancer

01/03/2007 09:11 AM |

An article in the journal of the National Cancer Institute will send chills down the spines of those who want to simply measure the value of new cancer medicines in terms of survival (as we search for better ways to target drugs to the right patients):

Here's Lauren Neergard's article from the AP
http://news.yahoo.com/s/ap/20070103/ap_on_he_me/cancer_time_lost

"The hours spent sitting in doctors' waiting rooms, in line for the CT scan, watching chemotherapy drip into veins: Battling cancer steals a lot of time — at least $2.3 billion worth for patients in the first year of treatment alone.

So says the first study to try to put a price tag to the time that people spend being treated for 11 of the most common cancers.

Even more sobering than the economic toll are the tallies, by government researchers, of the sheer hours lost to cancer care: 368 hours in that first year after diagnosis with ovarian cancer; 272 hours being treated for lung cancer, 193 hours for kidney cancer.

That doesn't count the days spent home in bed recovering from surgery or weak from chemo, just time spent actively getting care — chemo or radiation therapy, blood tests or cancer scans, surgery or checkups, driving to medical appointments and waiting your turn."

Too bad the study didn't calculate the value of time wasted listening to people explain why we can't afford new cancer drugs that aren't cost effective.

Here's a link to the article by Larry Kessler of the FDA and Scott Ramsey of the Fred Hutchinson Center

http://jnci.oxfordjournals.org/cgi/reprint/99/1/2  Read More & Comment...

Much Ado About Knockoffs

01/02/2007 03:12 PM |

I saw the article in the Guardian about "ethical pharmaceuticals" later than did Peter. This is the same Guardian that finds Israeli responses to terrorist attacks as "disproportionate" while running articles that portray Hamas as becoming more warm and cuddly.

The pegylation process that Professor Sunil Shaunak from the Hammersmith campus of Imperial College London and Professor Steve Brocchini from the London School of Pharmacy have developed is novel but not new. PEGylation is the process of attaching a large sugar molecule to a protein so it is harder to breakdown. In essence, a little less medicine goes a longer way. You save money - in theory -- by using a PEGylated product.

What the two have done -- through their own brand new private company -- is develop a new way to attach the PEG to the protein.

This is great for monoclonal antibodies but not much else. In any event, the firm is now partnering with an Indian company whose product has been approved in India but nowhere else to make a more cost-effective product.

Will it be more cost-effective or cheaper compared to other interferons? It might be. Their products might be considered follow products or bio-generics in Europe depending upon the formulation.

But let's be clear. This is not the Holy Grail for drug discovery and development the Guardian makes it out to be. Polytherics is not validating targets, testing validated target and trying to come up with a molecule that might inhibitor a pathway or shut down replication of a protein and then seeing if it works at a specific dose. They are adding -- in a new way -- a sugar to proteins to make them more bioavailable. This is interesting but not revolutionary.

All this noise about conducting clinical trials in India to save money is garbage. Everyone is doing that. It's the cost of investing in one failure after another or finding a way to reduce that cost or the number of failures...now that would be a real contribution. Now as for being holier than thou these ethical scientists apparently have no problem hiring the same lawyers who represent the monpolistic drug companies they hate to protec their own IP. Haven't they heard about shareware?

Meanwhile, Polytherics have no guarantee that producing companies won't just mark up the price of these drugs -- if they ever pass legal muster -- and continue to give the shaft to the poor in developing lands. That is, all they are doing is giving generic firms another way to exploit the poor and make profits without really adding much to innovation. There is no guarantee that this product will work as promised either.

Perhaps it was best said, as a Financial Times article today notes, by Jean-François Dehecq, the chairman of Sanofi-Aventis of France.

Dehecq said he was "scandalised" by generic groups producing low-cost medicines in poor countries to sell to patients in rich nations.

Not as scandalised as he will be by Polytheric partnering with said generic firms to develop another way to screw the poor and use them as human lab rats purely for profit.

Maybe Jamie Loves wants to give these guys part of his Genius Award or create a new category:

Best New Way To Use the Poor As An Excuse To Attack Big Bad Pharma And Exploit Them in the Process.  Read More & Comment...

Bitter Pills

01/02/2007 01:40 PM |

Excellent "special report" on counterfeit prescription medicines in the December 18, 2006 edition of BusinessWeek.

Here's the link:

http://www.businessweek.com/magazine/content/06_51/b4014064.htm

Two snippets to whet your appetite for more ...

First, as to the scope of the problem:

* Based on a study of 185 sites, Columbia University's National Center on Addiction & Substance Abuse reports that only 11% of Internet pharmacies require customers to provide a prescription. All the rest, an astounding 89%, appear to operate illegally. Conservative estimates of the number of dubious sites reach into the tens of thousands, according to Internet Crimes Group Inc., a corporate consulting firm.

And second, to those politicians and pundits who claim that counterfeiting is nothing but a Big Pharma "scare tactic," a cautionary tale:

* Craig Schmidt fell victim to questionable Internet medicine in April, 2004. The Chicago plastics salesman, then 30, was feeling the stress and back pain of long workweeks often spent on the road. Checking his e-mail one day, he noticed ads for Xanax and the painkiller Ultram. He placed $400 in orders without ever speaking to a doctor. When the pills arrived, he took one tablet of each drug and headed for an errand at the hardware store. The next thing he remembers is waking up three weeks later in the hospital. It turned out that each Xanax tablet contained 2 mg of the drug, or quadruple the usual starting dosage. The combination apparently caused him to black out and wreck his car. He had a heart attack, fell into a coma, and suffered brain damage. After an extraordinary recovery, he still takes medication to prevent severe leg spasms. "Don't do what I did," he says. "It's like playing Russian roulette."

BusinessWeek also ordered some "product" from selected websites. The Xanax the investigative team ordered had zero active ingredient, as did the Lipitor it purchased.

Well say it again -- counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.  Read More & Comment...

"Ethical" my Aunt Fanny

01/02/2007 11:27 AM |

How about this for a solution to drug prices -- let's trash intellectual property rights. (Now why haven't I thought of that before? I know -- because it's a very bad idea for about 1000 reasons with Reason #1 being that it would end pharmaceutical innovation and Reason #2 being it would seriously -- very seriously -- impact quality control. Reasons #3 - 1000, as Rabbi Hillel might have said, are just commentary.

Not surprisingly, this article (from today's Manchester Guardian) came my way via a bizzarro Jamie Love listserve. At the end of the day, you can call it anything you want, but what it boils down is cost-centric versus patient-centric medicine. "Ethical pharmaceuticals" indeed!

Scientists find way to slash cost of drugs
Indian-backed approach could aid poor nations and cut NHS bills

Two UK-based academics have devised a way to invent new medicines and get them to market at a fraction of the cost charged by big drug companies, enabling millions in poor countries to be cured of infectious diseases and potentially slashing the NHS drugs bill. Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.

The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.

Professor Shaunak and his colleague from the London School of Pharmacy, Steve Brocchini, have linked up with an Indian biotech company which will manufacture the first drug - for hepatitis C - if clinical trials in India, sponsored by the Indian government, are successful. Hepatitis C affects 170 million people worldwide and at least 200,000 in the UK.

Multinational drug companies put the cost of the research and development of a new drug at $800m (£408m). Professors Shaunak and Brocchini say the cost of theirs will be only a few million pounds.

Imperial College will hold the patent on the hepatitis C drug to prevent anybody attempting to block its development. The college employs top patent lawyers who also work for some of the big pharmaceutical companies.

Once the drugs have passed through clinical trials and have been licensed in India, the same data could be used to obtain a European licence so that they could be sold to the NHS as well.

Professor Shaunak says it is time that the monopoly on drug invention and production by multinational corporations - which charge high prices because they need to make big profits for their shareholders - was broken.

"The pharmaceutical industry has convinced us that we have to spend billions of pounds to invent each drug," he said. "We have spent a few millions. Yes, it will be a threat to the monopoly that there is.

"I'm not only an inventor of medicines - I'm an end user. We have become so completely dependent on the big pharmaceutical industry to provide all the medicines we use.

"Why should we be completely dependent on them when we do all the creative stuff in the universities? Maybe the time has come to say why can't somebody else do it? What we have been struck by is that once we have started to do it, it is not so difficult."

The team's work on the hepatitis C drug has impeccable establishment credentials, supported by a grant from the Wellcome Trust and help and advice from the Department for Trade and Industry and the Foreign and Commonwealth Office.

But the professors' ethical pharmaceutical model is unlikely to find much favour with the multinational pharmaceutical companies, which already employ large teams of lawyers to defend the patents which they describe as the lifeblood of the industry.

One industry insider envisaged legal challenges if the new drugs were not genuinely innovative. It could become "a huge intellectual property issue", he said.

Guardian Unlimited © Guardian News and Media Limited 2007  Read More & Comment...

You want fries with that?

01/02/2007 09:11 AM |

Meat and milk from cloned animals! Calls for absurd, unscientific labeling!

Just another day at the FDA.

According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.

Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.

You want fries with that?

In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.

By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.

"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.

Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.

Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.

(Sorry about that.)  Read More & Comment...

Part-D Hearty

01/02/2007 08:48 AM |

Eureka! It works.

Attention Speaker Pelosi ...

ASSOCIATED PRESS

WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.

As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,” said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.”

Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.

Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,” Copeland said.

Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.

The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.

Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.

The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,” she said.

The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,” she said. “I would say that around March, or late February, things started to calm down.” She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.

Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,” she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.”

Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,” Kuhn said.

Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.

Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,” he said. “As a result of the new program, beneficiaries are living better. They're saving money.”  Read More & Comment...

Vipers of another variety

01/02/2007 07:16 AM |

In the heydays of “drugs from Canada,” there were news stories aplenty about the “Winnipeg Wunderkids,” the young pharmacists who were selling drugs to Americans and driving around in Dodge Viper sportscars. These reports rarely mentioned that they were trafficking in illegal merchandise. And there was a lot of talk of “it’s not about the money, it’s about helping people.”

That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.

Here’s the story as reported in the Winnipeg Free Press.

MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.

At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.

CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.

A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.

The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.

"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.

So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.

CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.

Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.

MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.

It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.

No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.

Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.

For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.

Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.

"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."

MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.

The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.

"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.

However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.

"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.

Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."

No, not political. Financial. They took the money and ran.  Read More & Comment...