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...

Deja New Year

01/01/2007 12:20 PM |

Woke up this morning early from a recurring dream. Something to do with suiting up with a new bunch of team mates and an old high school football coach. I want to show them I can still grind out the yardage. No sense of frustration, just hope and confidence.

Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.

So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:


Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How

CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.

Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":

"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."

Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......

I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.

So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.

Here's another one from the Pink Sheet:

Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis” of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..

Duh.

Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.

Your PDUFA and tax dollars at work.  Read More & Comment...

Counterfeiting Means Having To Say You're Sorry

12/31/2006 02:31 PM |

This from China...

Pfizer Inc. won a trademark case in China blocking drugmakers there from copying its Viagra impotence pills' blue diamond shape.
A Beijing court ordered the three companies to pay a $38,000 fine to Pfizer, stop producing the blue, diamond-shaped pills -- which didn't contain the active ingredient in Viagra -- and print a public apology in a Chinese legal newspaper.

(Viagra is known affectionately as "great brother" in China. Obviously lots of folks who purchased the the pill without the active ingredient wound up with "weak sister"instead. )

Now if we can only get Rahm Emanuel, Byron Dorgan, Debbie Stabenow, et al, to print a public apology in an American paper for sponsoring legislation that would encourage these companies to continue producing fake drugs.  Read More & Comment...

Slug Brains and Sluggish Brains

12/31/2006 02:04 PM |

Sea Slug Offers Clues to Human Brain Disorders....

Why am I not surprised?

According to an article at livescience.com :


The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging

They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.

The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."

Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.


And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....

High-Tech Mammograms Will Change Breast Cancer Care

By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET

(HealthDay News) -- The mammogram is changing for the better.

New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.

High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.

While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.

A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.

The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.

Here's the full article:

http://www.livescience.com/healthday/531925.html

Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....  Read More & Comment...

Too Many Cancer Drugs: Part II

12/30/2006 08:03 PM |

Es ist nichts schrecklicher als eine thatige Unwissenheit…That’s Goethe for “There is nothing scarier than an active ignorance.”

I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).

It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?

So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?

And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...

"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.

"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."

See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm

Yeah but that means even more cancer drugs. Don't we have enough already?  Read More & Comment...

Sneak Preview of the Best New Health Care Idea for 2007

12/28/2006 01:15 PM |

Steve Hofman, my friend, mentor, fellow Yankee fan has come up with the best new health care idea for 2007.

In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:

"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."

Pay seniors to save their own money and control Medicare spending to boot.

How would it work?

"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."

There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.

One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."

That dough would be split 50-50 by seniors and the Treasury.

All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.  Read More & Comment...

Year in Review: Lowlights of 2006

12/27/2006 12:40 PM |

Thinking back on all the postings Peter and I...posted, it's amazing to consider just how much of a hassle the echo chamber of journalists, politicians and anti-capitalist 'experts' have become to the advance of medical progress.

When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:

Go see it and see for yourself why you shouldn't go see it.

In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?

In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.

Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.

Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?

But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.

Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.

And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.

As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:

"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."  Read More & Comment...

Nature Articles on Obesity, Diabetes and Metabolism

12/25/2006 11:47 AM |

Excellent series of papers on the the relationship between obesity, diabetes, heart disease, inflammation, etc....the genetic and cellular mechanisms that control all and the variations thereof.

Here's the link..

http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html



Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..  Read More & Comment...

Biomarkers and Mental Illness

12/24/2006 10:00 AM |

The rapidly advancing fields of proteomics and metabolomics may provide the tools necessary to develop predictive tools and tests for early and accurate screening of devastating mental illnesses such as schizophrenia and manic depression....

PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.

"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."

PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.

Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.

No biological basis for mental illness?

"There is nothing more frightful than ignorance in action" Goethe  Read More & Comment...