NIH Caves In To the Medical Moral Mob

01/19/2007 10:26 AM |

Now that the Democrats control the purse strings, left wing organizations will try to force their ideology on to science-based federal agencies. It will happen with the FDA and it has just happened with NIH where the crazies have decided that because researchers consult for industry they are a notch below or above being criminals. It's not enough that talented NIH scientists are leaving the agency in droves. Now anyone who lectures on subjects they know about can't participate in guideline development. That leaves people who, of course, are loyal to the left wing agenda of groups like the Center for the Science in the Public Interest.

As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.

Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.

Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."

All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.

NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong

The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.

The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.

The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.

In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.

The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.

The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.

The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."

As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.

The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.

According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.

Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.

The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.  Read More & Comment...

Extending VA to the Rest of the Universe: Been There, Flubbed That

01/18/2007 06:20 PM |

Lest anyone thinks that the brilliant suggestion that the government use its bulk purchasing power to drive down drug prices using the VA system is something new or will work like a charm...step into drugwonks Wayback machine and journey back to the year 2000, the last time the Yankees were World Champions and Al Gore did not tip the scales at 300 pounds......

This from US Medicine Information Central...

" While it may take two to tango, the SAMBA issue hanging over the Department of Veterans Affairs and pharmaceutical manufacturers is drawing a full dance card.

SAMBA in this case stands for the Special Agents Mutual Benefit Association, a participant in the Federal Employees Health Benefits Program (FEHBP). It covers about 16,000 employees and retirees of the Federal Bureau of Investigation and other federal law enforcement agencies and their dependents.

Under a two-year pilot project now in effect, SAMBA will have access to the Federal Supply Schedule (FSS) and its discounted drug prices as a means of holding down the size of premium increases. Office of Personnel Management (OPM) officials, who approved the pilot after SAMBA requested access to the FSS, say the "experiment" will provide valuable experience in establishing a schedule similar to the FSS for the entire FEHBP.

FSS discounted pricing generally is available only to the "big four" federal agencies that provide health care directly�VA, the Defense Department, the Public Health Service and the Coast Guard. Drug manufacturers are concerned that the SAMBA pilot could lead to a drop in revenues by making discounted pricing available to the entire FEHBP, which covers about 9 million "beneficiary lives"�and perhaps even extending it to other big-ticket programs such as medicare and medicaid."


A no-brainer right? In more ways than one...

Seems as though the VA had a problem or two with the project...

"Veterans advocates caution that the pilot ultimately could cut into the funds available to care for veterans by prompting manufacturers to raise the discounted prices they give to VA to make up for the funds lost because of the pilot or the creation of a new FEHBP pricing schedule. The issue is a complex one involving subparts of federal regulations and bureaucratic purchasing arrangements between drug firms, pharmacy benefit managers and the VA. A meeting held for manufacturers last month at OPM drew a full house but few questions, especially after an attorney from the Pharmaceutical Research and Manufacturers of America (PhRMA) cautioned that individual company reactions to the pilot program could not be discussed without violating antitrust regulations."

And companies simply walked away...

Washington Matters - November 2000
from Drug Benefit Trends

Big Drug Makers Scuttle New Drug Coverage
The federal government has backed off from a test of a new way to pay for the medications used by its employees. The reason for scuttling the pilot project is that both Pfizer and Merck refused to go along. The idea was that the 16,000 active and retired federal law enforcement employees who receive health care coverage through the health plan of the Special Agents Mutual Benefits Association (SAMBA) would be able to buy medications by mail and have them supplied through the Federal Supply Schedule (FSS). The FSS lists the price the government will pay for 17,000 drugs -- generally, about half the wholesale price of the product or around what the drug makers charge to their best private sector customers. The federal Office of Personnel Management (OPM) decided it could not go forward with the plan with the 2 major suppliers, who refused to fill orders from SAMBA enrollees at FSS prices."

Imagine what would happen if Medicare tried to extend VA prices to 50 million seniors.

Walk away? More like a stampede.  Read More & Comment...

Tin Cupping Along the Critical Path

01/18/2007 07:09 AM |

The always astute (and sometimes ascerbic) Steve Usdin of BioCentury has written an important and stimulating article on the road to PDUFA reauthorization.

Must reading.

Here's the link:

Download file

And many thanks to BioCentury for their permission to post this article in its entirety.  Read More & Comment...

Alex Azar Resigns. Tears for HHS.

01/17/2007 02:14 PM |

I've been getting a bunch of calls in the wake of the announcement that Alex Azar will resign as Deputy Secretary of HHS. People want to know what will it mean for this, what will it mean for that. But here's what's important: Alex brought the power of both compassion and intellect to HHS. His departure doesn't mean we'll see any particular shift for any given industry or issue, but it does mean that HHS will lose a certain dimension of thought leadership and sophistication.

Good Luck Alex.  Read More & Comment...

Cancer Deaths Drop For Second Straight Year Thanks to Breakthrough Drugs That Dems Want To Price Control

01/17/2007 12:03 PM |

Here's the story according to AP

"Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.

After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.

The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.

The trend seems to be real, Cancer Society officials said.

"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.

Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.

Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."

In the wake of this good news, the Dems are seeking to price control unique drugs -- breakthrough medicines in otherwords.

Which means medicines like those that helped reduce dying due to cancer.

Which means medicines from biotech firms that create these miracles.

The Clintons tried proposing a breakthrough drug pricing trigger in 1994 that would hammer and yammer about the price of first in class meds and whether they were all so cost effective or not. It caused biotech stocks to tank and venture capital to vanish.

I hope the D's listen to the Ron Pollacks of the world again and go ahead and do just that. As the Penn and Schoen poll shows, when people find out that price controls also mean an end to miracle cures, they hate price controls. But the D's are driven by their Beltway advisers and power brokers more than they are what people and patients truly want.  Read More & Comment...

Trouble in PDMA-Land

01/17/2007 10:26 AM |

A federal court judge has imposed a temporary injunction against the FDA over the agency's drug pedigree requirements, on the basis that the regulations leave sections of the supply chain unguarded and threaten the survival of smaller drug distributors.

Here’s a link to the complete story:

The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.

The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.

This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors.  Read More & Comment...

If it ain't broke ...

01/17/2007 09:44 AM |

House-passed drug price bill has very little clout

By David Nicklaus
ST. LOUIS POST-DISPATCH

In any negotiation, the power lies with the person who's willing to walk away. That simple truth is obvious to anyone who's ever bought a car or a house, but somehow it escapes a majority of members of the House of Representatives.

When the House passed the Medicare Prescription Drug Price Negotiation Act last week, it ordered the government to lean on the big, bad pharmaceutical companies to get lower prices. But it also prohibited Medicare from establishing a formulary that would pay for some drugs and not others.

In other words, Medicare would have to ask drug companies to cut their prices, but it would have no leverage. It would have to cover all drugs, regardless of price. This is a change from current law, which bars the government from negotiating prices, but it's a change without substance.

You don't have to take my word for it. You can read a letter that the Congressional Budget Office sent to Rep. John Dingell, D-Mich. It says that the Price Negotiation Act "would have a negligible effect" and predicts that the government "would be unable to negotiate prices … more favorable than those obtained by prescription drug plans under current law."

Why would Congress ask Medicare to dicker with drug companies while banning the one tool that would really give Medicare some clout? The politicians apparently want to curry favor with elderly voters and with lobbying groups like AARP.

Senior citizens may worry about high prescription costs, but they certainly don't want any bureaucrat telling them which medications they can or cannot take.

A truly low-cost drug plan would have to look something like the one available to military veterans. The Department of Veterans Affairs formulary covers only 1,300 drugs, compared with 4,300 available in the typical Medicare Part D plan, says Peter Pitts, director of the Center for Medicine in the Public Interest. Thirty percent of veterans, he says, would like to switch to Part D, but they're not eligible because they already have VA coverage.

Part D plans are offered by private insurance companies, which have the option of using restrictive formularies. Most of them keep their coverage broad in order to attract customers, but just having the right to drop a drug — like threatening to walk away even though you really like the car — gives the insurers clout.

The Congressional Budget Office says insurance companies have "both the incentives and the tools to negotiate drug prices that the government, under the legislation, would not have."

If Congress really wants to reduce health care costs, it's looking in the wrong place. Prescription drugs account for just 11 cents of each health care dollar, compared with 32 cents spent at hospitals. By giving senior citizens easier access to the drugs that help manage chronic conditions, one could argue that Medicare Part D has kept many people out of hospitals.

Pitts, a former associate commissioner of the Food and Drug Administration, says Part D has surprised critics by becoming enormously popular with the over-65 crowd.

"The premiums are coming in below expectations, the cost to government is below expectations and the coverage is very good. That sounds to me like a program that is working," he said.

Congress, unfortunately, has never shied away from fixing things that are not broken.  Read More & Comment...

Penn -- and Tell Her

01/17/2007 07:03 AM |

Remember when we suggested that polls showing the American public strongly in favor of "government pricing" for Part D might be, er, influenced by the way the questions were posed("The Big Muscle," drugwonks.com, December 8, 2006)?

Well according to Mark Penn (aka: Hillary's new chief campaign strategist), that's precisely the case.

And the "Her" is Speaker Pelosi.

Penn, Schoen & Berland Associates and The Tarrance Group recently conducted a joint national poll measuring public opinion on the current legislative proposal that would require Congress to negotiate Medicare prescription drugs prices with pharmaceutical companies.

The summary below is really a summary judgement against "government pricing."

When Downsides are Understood, Voters Oppose Government Negotiation

While voters offer initial support for the current proposal that would require Congress to negotiate Medicare prescription drug prices with pharmaceutical companies, once voters are educated about the potential implications of the proposal, the public overwhelmingly opposes it.

* Initially, 76% of voters support government negotiation and 24% oppose it. However, when this question is asked, voters have received no details about the proposal or its possible consequences.

* After being asked about the negative implications of the proposal, opinion flips – only 35% support government negotiation and 65% oppose it. There is majority opposition across Democrats, Republicans and Independents.

Fear of the Government Limiting Access to Prescription Drugs Shifts Public Opinion

Learning that the proposal could limit access to prescription drugs dramatically erodes support for government negotiation.

* 89% oppose the proposal when they learn it could limit access to new prescription drugs.

* 87% oppose the proposal when they learn it could restrict choice of prescription drugs.

* 86% oppose the proposal when they learn similar proposals in other countries like Great Britain and Australia have restricted access to prescription drugs.

* 77% oppose the proposal when they learn that it give the government the right to create a single list of government-approved prescription drugs.

* 80% of voters judge the proposal as “not worth it” after learning that the Congressional Budget Office has reported that granting the federal government the power to negotiate drug prices will not save enough money to fill gaps in coverage.

Voters Have Clear Reservations about Government Negotiation

Voters were asked a series of questions about their opinions of government negotiation, which collectively suggest deep reservations about the proposal.

* 81% agree that the government is not a good price negotiator

* 78% agree that government negotiation would limit access to prescription drugs

* 75% agree that the market should set prescription drug prices, not the government

* 66% agree that government negotiation gives the federal government too much authority and is a dangerous precedent

Medicare Part D is Currently Well Received

Currently, opinion on the Medicare Part D prescription Drug program is very positive and improving.

* 55% of voters nationally have a favorable opinion of the program

* 61% of voters nationally say enrollees are saving money

* 68% of voters nationally say the program a step in the right direction

Other public surveys have repeatedly reported that satisfaction levels among enrollees are much higher; roughly eight-in-ten enrollees expressing satisfaction with their plans.

In conclusion, any legislation that jeopardizes the success of the Medicare Part D Prescription Drug Program would likely have a negative impact on the general public’s opinion of Congress.

Methodology

Penn, Schoen & Berland Associates and The Tarrance Group conducted 1,098 national interviews between December 19 - 22, 2006.

Interviews were conducted among Americans who voted in the 2006 midterm elections.

The overall margin of sampling error is +/-2.96% and larger among subgroups.  Read More & Comment...

Jo Ann Emerson: Fertile Grounds for Criticism

01/16/2007 05:37 PM |

We are often criticized for being too critical of people in the public eye. So I will try and be extra careful in my remarks about Jo Ann Emerson of Missouri. She stood with Democrats to sponsor HR 4 the bill that would have required price controls for prescription drugs in the Medicare program. And she is a co-sponsor of a bill that would require reimportation of drug from foreign countries, a bill that would make it a criminal activity for companies to determine which wholesalers they want to sell to and would turn the FDA into a parcel service for European middlemen. Ms. Emerson has been vocal, indeed eloquent in her support for price controls on drugs and for allowing the importation of drugs that are cheaper from other countries due to government price controls and not because of any ingenious production method or competitive practice of another company.

Ms. Emerson says "The high cost of prescription drugs in the U.S. demands that we improve Americans' market access to safe, affordable supplies of medicines."

One of the medicines Ms. Emerson is so concerned about?

"Prilosec, they use it for gas and that sort of thing..."

Setting aside Ms. Emerson's deep knowledge of phamacotherapy, it appears her concern about the high cost of products and free trade does not extend to steel or wheat or . fertilizer from Mother Russia...

She, supported American steel companies seeking duties up to 40 percent on imported metal products and sought to ban the importation of low priced Canadian wheat. At the same time. she has opposed an International Trade Commission ruling that Russia was dumping fertilizers into America at predatory prices, because the resulting tariffs would hurt farmers.

So she opposes the importation of low priced products when it comes to wheat and steel, supports the importation of fertilizers because it helps farmers.

And she supports signficant increases in agricultural subsidies, most of which go to large corporate farms on grounds of national security....


"Re-authorizing the farm bill is the best thing to do right now," she said. "Because if we want to be dependent on countries in the world who hate us for our nation's food, then we might as well fold up shop."

But being depending on countries who hate us for our medicines is ok? Does she know who works at most of the major ports in Europe and Canada by the way?

If you find no logic or consistency to this voting -- if you smell rank opportunism as opposed to intellect driving these decisions you are not alone. For more evidence, I offer the following quote from Ms. Emerson herself explaining why she is voting with the Democrats, now that they’re in the majority, rather than with her leadership (from the NY Times):

"You're freer to vote your conscience," said Rep. Jo Anne Emerson (R-Mo.), who received an 88 percent voting record from the American Conservative Union in 2005 but has so far sided with Democrats on new budget rules, Medicare prescription-drug negotiations, raising the minimum wage and funding stem cell research. "Or, really, I feel free to represent my constituents exactly as they want me to be."

Translation: My principles. They use it for gas and that sort of thing.  Read More & Comment...

Pharmaceutical Imperialism

01/16/2007 09:00 AM |

Rahm Emanuel has probably never been called an "imperialist." But that's about to change. Now that he (along with Representative Emerson and Senators Snowe and Dorgan) are calling for legalizing "drugs from Canada," the Canadian Pharmacists Association, the Ontario Pharmacists' Association, the Best Medicines Coalition and the Canadian Association for Pharmacy Distribution have called on Canadian Health Minister Tony Clement to implement "an immediate ban on the export, both bulk and retail, of prescription drugs from Canada."



Here's the story from today's Toronto Globe and Mail:

http://www.theglobeandmail.com/servlet/story/LAC.20070115.PHARMACY15/TPStory/?query=pharmacists

In short, they're saying "hands off our medicines, imperalist American."  Read More & Comment...

Universal Care Expands Perverse Care

01/15/2007 04:57 PM |

Want to know how the health care system operates...read Vanessa Furhman's article in Friday's Wall Street Journal " A Novel Plan Helps Hospital Wean Itself Off Pricey Tests" (The headline is a bit misleading) which describes how health care financing discourages ways to pay doctors and use technologies that prevent disease and keep people healthy.

http://online.wsj.com/article/SB116857143155174786-search.html

In a perfect world we shouldn't expand access to health care in ways that sustain this stupidity. We should give the money to providers and plans that actually will demonstrate they will improve health. That means expanding SCHIP or access to adult health care through Medicaid or Medicare is just flushing money down the toilet...  Read More & Comment...

The Left Jumps The Shark: Merrill Goozner's Part D Meltdown

01/14/2007 09:57 AM |

Merrill Goozner of the Center for Science in the Public Interest (not to be confused with us) is in meltdown mode over the Washington Post editorial warning about government run medicine.

Here's his post on Huffington Post

http://www.huffingtonpost.com/merrill-goozner/the-right-prescription_b_38579.html

Fun to watch, but let try to make a couple of serious points here to demonstrate the faulty logic of the left...Clearly a case of their rhetoric on pharma jumping the shark.

Gooz claims that the VA is restrictive because is it not tainted by prescribing guidelines shaped by industry. All the guidelines are written by industry? Let's say that's the case. Fact is, the VA docs follow EVERY specialty association guideline in terms of treatment steps. So I guess that the industry should be given credit for something.. Then again the VA only differs in terms of drug selection and therapeutic approach.

Then again, not all government guidelines meet the Goozner standard. Hypertension guidelines and ALLHAT yes. Cholesterol guidelines that encourage earlier use of statins no. The latter were the tainted in his opinion because the doctors on the committee had industry ties. But so did everyone on the ALLHAT steering committee. What's the the difference? Gooz likes the fact that an ALLHAT rump section spun the results as generic drugs worked just as well as newer meds.

He claims that the VA does a great job weeding out pricey me too drugs...Again, he should thank the industry for creating competition among therapeutic choices based on value otherwise there would only be one in a class drugs which the VA keeps off formulary for at least 1-3 years. What will the VA do in an era of personalized medicine?

I won't even respond to the claim that the VA is doing all this great research. Sorry, it's all process measures.(Who get's what test and when) There are no studies compariing outcomes by drug and other variables. It has the ability to do that research but it never does...instead it supports studies that claim that the likelihood of suffering permanent nerve damage from older schizophhrenia drugs is ok and that old drugs are just as good as new. The fact is comparative effectiveness studies wind up showing that some people always do better on drug A than on drug B or vice versa. So the question is: how do get the right drug to the right patient first time every time? Goozner does not care and neither does the VA for that matter because it restricts formularies to save money on drugs not to improve outcomes.

Meanwhile, the real problem is that consumers are just too stupid or brainwashed to know any better. Or at least they are not as smart as Gooz. Consumers are being reprogrammed into new drug zombies that march into physician offices under the spell of pharmaceutical TV ads demanding inferior and expensive drugs which is why they want open formularies instead of the narrow ones offered by the wise and all-seeing pharmacy boards.

Here is the Gooz, oozing at his most hyperbolic:

"Consumers are going to police the system through their individual choices? Are these the same consumers who are bombarded daily with direct-to-consumer ads touting the latest me-too drug on television, in the pages of their daily newspapers and in weekly magazines? Such poorly informed consumers will likely gravitate over time to the least restrictive formularies precisely because they include drugs that are no better than generics." (Meanwhile consumers in these open formularies are stampeding over to generics.)

Yeah, we are just too stupid and too brainwashed. Teach us Merrill. Show us the light, the truth and the way.  Read More & Comment...

The Most Unhappy Fella

01/13/2007 02:35 PM |

Yesterday's vote on "government pricing" of prescription medicines garnered the fewest votes of Speaker Pelosi's "First 100 Hour" pieces of legislation. Legislators are seeing the light.

As Everett Dirkson was fond of saying, "When I feel the heat, I see the light."

And the heat is from America's seniors who are pleased with the Part D drug benefit.

And the heat is from, among other places, the Washington Post. Here is what America's lawmakers woke up to find in their own Newspaper of Record:

The Wrong Prescription
Government should not negotiate drug prices in Medicare.

HOUSE Democrats delivered on a campaign promise yesterday, passing a bill that would require the government to negotiate the price of pharmaceuticals covered by the new Medicare drug benefit. The idea is that government negotiators could force prices down, generating savings that could be used to make the benefit more generous. But the measure is misguided.

Here's a link to the complete editorial:

http://www.washingtonpost.com/wp-dyn/content/article/2007/01/12/AR2007011201885_pf.html

And the most unhappy fella in DC today is Rahm Emanuel -- sponsor of the Newspeak-named "Pharmaceutical Market Access and Drug Safety Act which demands "world pricing" as well as drug importation.

If only 24 Republicans voted for HR 4, the chances for Mr. Emanuel's legislation are about as good as Nancy Pelosi calling for a statue of Charlie the Tuna in Dupont Circle.

Here's what Mr. Emanuel's constituents woke up in today's Chicago Sun-Times:

Cheaper drugs would come at a steep price

BY PETER J. PITTS

U.S. Rep. Rahm Emanuel (D-Ill.) has announced legislation "aimed at driving down the price of prescription drugs." But the only thing such legislation would actually drive down is pharmaceutical innovation.

And here's the link to that article:

http://www.suntimes.com/news/otherviews/209130,CST-EDT-REF13A.article

Even the New York Times is reporting that the Congressional Budget Office (CBO) study on "government pricing" shows that direct negotiations wouldn't save America's seniors any money.

America's legislators are beginning to feel the heat of truth and see the light of day -- that "government pricing" and quick fixes like drug importation are false promises -- and that the American people know it.  Read More & Comment...

Avoiding the Price Trap in the Prescription Drug Debate

01/12/2007 05:11 PM |

The good news is that the House passed the price control bill by the slimmest margin of any of the pieces of legislation introduced by Democrats during the 100 horrors campaign. Not enough votes to override an expected presidential veto. Which puts pressure on the Senate.

The bad news -- or at least the takeaway from all this -- is that opponents of price controls did not stress enough just how many seniors and disabled people (40 million and counting) now have coverage where they did not have it before. And combined with patient assistance programs, it means that America has gone a long way to making medicines affordable for those who need and use them most.

This has gotten lost in the debate about prices...always does. And so it is important to hammer home the point that more people are getting their drugs paid for -- at $200 billion less than expected -- with more choices than ever before. This will prevent disease and save money in Medicare overall. People are suffering less and living better as a result. Every dollar of new drug consumption reduces spending for other services by about seven or eight dollars.. We need to make that investment and we need more valuable ad effective drugs to make a greater difference.

Which is what should be emphasized. Disease still is more expensive than any drug. And making people pay for the most cost-effective and valuable part of health care makes no sense at all. We need to spend more on medicines, not less and we need to find ways to encourage that spending and ensuring that people are using medicines right for them, the first time. Now that's one way to fill the donut hole: personalizing prescribing to reduce side effects and provide more timely feedback.  Read More & Comment...

Drugwonks on the Pelosi Prescription Price Club

01/12/2007 09:11 AM |

Peter and I have op-eds today in Newsday and The Washington Times respectively on the Pelosi Prescription Price Club proposal to be voted on today.

Here are links to both ...

http://www.newsday.com/news/opinion/ny-opfri125048767jan12,0,1225572.story?coll=ny-viewpoints-headlines

http://washingtontimes.com/op-ed/20070111-084554-5979r.htm

And a Washington Times editorial on Medicare part D:

http://washingtontimes.com/op-ed/  Read More & Comment...

AARP: Getting Old and Forgetful

01/12/2007 07:34 AM |

Here we go again.

Remember the Pharmaceutical Market Access and Drug Safety Act? That’s the ill considered Emanuel/Emerson/Snowe/Dorgan bill that wants the US to import “world prices” along foreign drugs.

Well, the AARP has come out strongly in favor – particularly on the drug importation provision.

It seems that the AARP is getting old and a bit forgetful. Wasn’t is just recently that they pointed to Part D and said that it was a better deal than drugs “from Canada.” Short-term memory loss I suppose.

For more on this silly bill and the dangerous implications of drug importation, please see my December 22nd blog (“The John Grishams of Drug Importation”).  Read More & Comment...

Back to the Future ...Dems Proposing HHS Breakthrough Drug Price "Negotiations"

01/11/2007 05:44 PM |

In retreat Democrats still want to control drug prices. Now the target are breakthrough drugs or one of a kind medicines as they were called in congressional testimony today. That means an attack on the most vulnerable...biotech companies -- who spend billions on research with hardly a hope of breaking even in the near time -- on breakthrough drugs for dying or severely ill patients.

We have be there before with disastrous consequences.....

We are back to the future when it comes to what
proponents of price control supporters want. They are
proposing special negotiating authority for new,
unique drugs.

Under the Clinton health plan, (and my thanks to the Heallthcare Blog for tracking this history down) because new drugs often initially have very high
prices, the Secretary was to have the authority to
negotiate special prices for breakthrough drugs
considered overpriced and could exclude these new
drugs from coverage if a rebate agreement could not be
reached. The Act also would have created an Advisory
Council on Breakthrough Drugs, which would advise the
Secretary on the reasonableness of launch prices of
new drugs representing significant advances over
existing therapies. Although the findings of the
council would not be binding, they would influence the
Secretary and the drug payments of other entities with
purchasing power.

The Advisory Council would have had the power to hold
hearings, supeona records publicly reprimand companies
whose prices are deemed excessive, and recommend to
the HHS secretary that it deny such companies the R&D
tax credit, Medicare/Medicaid reimbursement, or full
patent terms. This proposal caused the stock prices
for biotech companies plunge 40 percent.


Back then leading Democrats caved in....

From a 1994 biotech news roundup

DRUG PRICE REVIEWS PROPOSAL DROPPED

In a move seen as a concession to the biotechnology industry,
Representative John Dingell (D-MI) announced last week that his
Energy and Commerce Committee is dropping a proposal to review
drug prices. The announcement apparently came in response to
pressure by Representative Lynn Schenk (D-CA), whose legislative
district contains 100 biotechnology companies. The Clinton proposal
would have established an Advisory Council on Breakthrough Drugs
to review charges of pharmaceutical price gouging. Schenk said, "The
proposal has already panicked financial markets and forced cutbacks
on research and development in the biotechnology industry." Carl
Feldbaum, president of the Biotechnology Industry Organization
(BIO), said, "Ms. Schenk has exercised extraordinary influence for a
freshman member of Congress. The ultimate winners will be the
people suffering from diseases that have no treatment or cure."

If Democrats want to repeat this part of history, they will get hammered even harder than they are now on their mangling of Part D.  Read More & Comment...

How To Speak Pelosian

01/11/2007 05:41 PM |

My attempt to help people parse out Nancy Pelosi's health care Newspeak...from The American Spectator

http://www.spectator.org/dsp_article.asp?art_id=10863  Read More & Comment...

Well said Senator Grassley

01/11/2007 05:09 PM |

As any regular drugwonks reader knows, we have our differences with Senator Grassley on many issues. Significant differences.

But we all share the belief that the Part D benefit is working -- and working well ... and that Congress shouldn't start to monkey around with it for political purposes.

Here's what Senator Grassley had to say on the floor of the Senate:

Download file

We here at drugwonks hope that Senator Grassley will take similarly fact-based positions during the upcoming PDUFA debate.  Read More & Comment...

Price Controls By Any Other Name

01/11/2007 01:09 PM |

I gobbled a handful of reimported Xanax from Rahm Emanuel's Reimported Drug Emporium (Same Taste. None of the Ingredients) and strapped myself into my office chair to watch the Senate Finance Committee hearings on Medicare price control proposals.

Four major takeaway points:

1. Ron Wyden and Olympia Snowe are clueless about the impact their bill would have on biotechnology and breakthrough drug investment. It would allow any plan pissed off about the price of the unique products for cancer, Alzheimer's, Parkinson's or innovative medicines to run to the government and demand 'negotiation' using such tools as seizure of all records and receipts and other data to see if the price was justified. Certain prices and certain drugs would set off an automatic trigger for direct government negotiation. That's called punishing success and a recipe for destroying partnerships between NIH, academia and private companies -- most of which yield information but no commercially successful products. Wyden's bill will kill off innovation and lead to influence peddling.

2. Most Senators are clueless about what drug development is and what drug companies do with respect to science. That is the drug industry's fault. And it's NIH's fault for not having the guts to say we rise and fall together instead of offering Senators this self-serving garbage that it is somehow the only wellspring of biomedical innovation. Companies had better get to work explaining their scientific enterprise, risks and all.

3. Senator Baucus made a throwaway comment as he was leaving about giving NIH more power to conduct more comparative effectiveness studies like ALLHAT and CATIE and information on what goes into drug pricing. This endorsement of evidence based medicine is misguided. Again, companies need to bring scientists and clinicians to explain why it is misguided and offer a patient-centered and personalized approach to prescribing. Like the Borg, the price control and formulary advocates will recalibrate their arguments to talk about cost-effectiveness as the benchmark for such decisions. That Commonwealth Fund lackey Gerard Anderson who is at Johns Hopkins (maybe he is the affirmative action hire for the intellectually mediocre) actually endorsed the Australian C-E guidelines as a backup for how drugs should be rationed at the hearing.

4. The community pharmacy lobby had better stay far, far away from Charles Grassley who did a great job defending Part D today... I disagree strongly with Grassley's grandstanding on drug safety but he had the opposition for lunch today. And he had the Democrats who were promising the community pharmacists higher dispensing fees in exchange for their support of their bill dead to rights. Grassley wanted to know how pharmacy lobby leadership could support a bill that would lead to the elimination of community drugstores.....

Oh, no one wants price controls and formularies...except Shameless Schumer. As I said in my previous post he should put his money where he mouth is..if there's room. If he thinks the VA exception process is so liberal let him follow the same procedures VA members go through....  Read More & Comment...