Animal Pharm

12/23/2009 05:17 AM |

Asking what healthcare in America is going to look like in 2010 is like asking who is going to win the World Series next fall: there are odds-on favorites – but you have to consider the wild card possibilities.

And, when it comes to health care, there seems to be nothing but wild cards. From “the deal” that Billy Tauzin cut with the White House to the future of follow-on biologics, from the “doc fix” to clinical effectiveness, from closing the doughnut hole to paving a pathway for follow-on biologics, there are enough issues in play to offer at least a dozen plausible scenarios. They’re all interesting and important. But some (in a very Orwellian sense) are more important than others.

The most important is the future of innovation.

For the rest of the story, see here.
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A Healthcare Carol

12/22/2009 09:38 AM |

Late one recent wintry night in the midst of congressional deliberations over healthcare reform, having worked hard on trying to reconcile the many swirling eddies of the current debate, I retired to bed for a few hours of fitful respite. That is until I was awoken from my solemn slumbers by a billowy translucent apparition who identified himself as the Ghost of Healthcares Yet-to-Come. 

“Away ye spirit,” I intoned, “for I need my sleep and indeed I see you for what you really are – a detail rep for prescription sleep aids.” “Nay,” replied the apparition. “I am here to reveal to you alternate realities for American healthcares yet-to-come.” And with a wave of his spectral hand appeared a magical black bag. “Look within,” he intoned.  “And see how the future of American healthcare can unfold.” “Did you bring a pizza by any chance,” I queried? “Sorry, can’t do that any more,” the ghost replied.  “Let our journey begin.”

 And so from inside his ebony satchel he ceremoniously withdrew a heavy, leather-bound tome with a caduceus embossed on the cover. “What alchemist’s manual is this?” asked I. “It is,” whispered the spirit, “from the cabinet of doctors Pelosi and Reid.  It is the final version of healthcare reform legislation.”

“Oh splendid visitor,” I pleaded. “May I gaze upon these pages and take notes for my blog? “NO!” the ghost sternly admonished. “You may look at the book but may never read what is inside – just like members of Congress before the final vote.”

“Not fair,” said I. “Alas,” the specter replied. “Such is the future when healthcare legislation is focused primarily on politics rather than on advancing the public health.”

“But it need not be that way,” my navigator continued. “Let us move on to an alternate future.” And with that he once again reached down into his black bag, revealing not a book but a Kindle. “Power it up,” he directed. “And see another future for American healthcare.

And it was wondrous. A future of enhanced access, innovation and accelerated approvals. A future where, with appropriate FDA guidance, pharmaceutical companies actively engage in social media.  A future where insurance companies reward their customers for medication compliance, weight loss, smoking cessation, and disease prevention.  A future with a national standard for electronic medical records and e-prescribing.  A future where the insurance industry offers high quality health policies across state lines to the many millions of previously uncovered Americans at significantly lower costs.  A future where reimbursement decisions are based on patient-centric concerns rather than 20^th century cost-centered models.  A future where physicians are compensated fairly by Medicare and Medicaid.  A future where, through enhanced transatlantic regulatory harmonization, there is no “approval gap” for drugs, devices, or diagnostics. A future where the only doughnut hole question we consider is cream-filled or regular. A future where drug importation is a side show panel not in the US Senate, but at Ripley’s Believe-it-or-Not.

“Can we peer into the future of the FDA,” I wondered.

“You’re such a wonk,” said my ethereal companion. “If you insist.”

And insist I did.  As I browsed further into the magic Kindle I saw an FDA that’s both regulator in protecting the public health and colleague in helping to advance it via the Reagan Udall Foundation. I saw an FDA with a cutting-edge information management system. I saw an FDA that embraces predictability over ambiguity. I saw an FDA that understands the unintended consequences of early risk communications.

 “Is such a future possible,” I asked.

“Indeed it is,” the eidolon answered.  “It is possible if we believe.”

“If we believe in what,” I asked.  “In Santa Claus?”

“No, intoned the wraith, “in the Non-Interference Clause. If we believe in free market competition and personal responsibility; in putting and keeping the patient in the center of every conversation; at long-term rather than short-term savings; in hard facts rather than political platitudes; in allies rather than enemies. If we believe that, in order to save lives, reduce costs, enhance quality, and deliver on the promise of robust health to all groups of Americans, all of the players in the health care debate - including government - must work together as a team, as a unit, as a public health defense force armed and ready to advance the public health.”

“How can we ensure this pathway,” I beseeched.

"Let me tell you,” said the phantasm, “what my friend Ebenezer Scrooge once said to a colleague of mine. He said that men's courses will foreshadow certain ends, to which, if persevered in, they must lead.” 

"But,” I asked, “if the courses be departed from, the ends will change. Say it is thus with what you show me."

But, before he could answer, I saw an alteration in the Phantom's hood and dress. It shrunk, collapsed, and dwindled down into a bedpost.

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A Cure Is Not In the Public Interest?

12/21/2009 07:01 PM |

Here's Timothy Jost, a health care expert, one of many who has never held a real job, let alone one in the health care industry or in the biotech business for that matter opining on why the worst feature of all the amendments to the health care bill is a proposal to coordinate translational research to speed products from benchto bedside:

"The Food and Drug Administration, the National Institutes of Health, and a new Cure Acceleration Network Board are supposed to work together to facilitate the discovery of such cures and to translate them from bench to bedside.  Grants can be made under the project of up to $15 million a year to eligible entities such as academic medical schools, biotech companies, and drug companies, who need only meet a $1 to $3 matching requirement.  $500 million is appropriated for this program for 2010. "

Now here's Jost's take:

"This is all well and good and a great idea.  But nothing that I can see in the legislation gives the taxpayer any stake in this investment.  A drug or biotech company that in fact discovers a blockbuster drug or biologic through the federal government’s investment (perhaps for an off-label use) owes nothing in return.  Shouldn’t we the taxpayers get some return on  our investment, or at least the promise of reasonable prices?"

So money losing biotech companies develop a cure for, say Alzheimer's, with the help of maybe a $3 million grant and Jost frets about the taxpayer return.  Am I missing something?  Meanwhile he has no problem with billions being scattered to various Senators and pet demonstration projects that perpetuate current halfway treatment patterns? 

If you want to know why health care reform is so....frustrating,  just look at Jost's parade of blogs on health policy. 

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Bending the Cost Curve Around The Neck of Old People

12/21/2009 04:07 PM |

No one is against cutting the growth of Medicare spending...but tell me if this Independent Advisory Board (how can it be advisory if it's decisions are binding?) is empowered to whack in the rate of increase in Medicare spending by about 25- 50 percent a year over 10 years starting now... 

Here's the OMB director to Harry Reid saying all bets are off when it comes to the human cost:

"Based on this extrapolation, CBO expects that Medicare spending under the legislation
would increase at an average annual rate of roughly 6 percent during the next two
decades—well below the roughly 8 percent annual growth rate of the past two decades
(excluding the effect of establishing the Medicare prescription drug benefit). Adjusting
for inflation, Medicare spending per beneficiary under the legislation would increase at
an average annual rate of roughly 2 percent during the next two decades—well below the
roughly 4 percent annual growth rate of the past two decades. It is unclear whether such a
reduction in the growth rate could be achieved, and if so, whether it would be
accomplished through greater efficiencies in the delivery of health care or would reduce
access to care or diminish the quality of care. "

And if so, will it even offset the explosion in costs triggered by tossing money to millions of middle class people for more generous health care or stem the exodus of doctors stuck with a 20-30 percent loss of income...

The impact of this legislation, if implemented, will reverberate through our culture and politics for decades.


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REgarding Importation

12/21/2009 08:27 AM |

Senior White house adviser David Axelrod said the Obama Administration "will push forward on safe re-importation of pharmaceutical drugs after the healthcare reform bill is finished."

According to Axelrod, "Let me be clear: The president supports re-importation, as he said, safe re-importation of drugs into this country. There's no reason why Americans should pay a premium for the pharmaceuticals that other people in other countries pay less for. And we will move forward on it."

If, by using the term “re-importation,” Axelrod means drugs that have been approved for sale in the United States, put on a truck or a plane or a ship and sent overseas – then he’ll be disappointed to find that there are precious few -- if any.  If, on the other hand, he means “importation” – then what he’s saying is that the President supports the importation of foreign price controls.

And if, by “safe re-importation,” he means that the FDA can somehow be the guarantor of global drug safety (or even guarantor of drug safety for a dozen or so foreign nations) – then he’d better seek out expert opinion on the matter.

A good place to start would be the FDA.

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And Tyler too

12/18/2009 04:20 PM |

Ralph S. Tyler III, Maryland's insurance commissioner and a former Baltimore city solicitor, announced Wednesday he is leaving state government for a federal post as chief counsel at the Food and Drug Administration.  Read More & Comment...

David joins Goliath

12/18/2009 07:32 AM |

FDA Assistant Commissioner for Policy David Horowitz to become a deputy general counsel at the Department of Health and Human Service's Office of General Counsel.

He’ll be missed.

Another opportunity for Commissioner Peggy to remake the agency in her own image.

(And that's a good thing.)

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Medicaid IS The Public Option

12/17/2009 06:13 PM |

The vast majority of people who will receive what is deemed health care coverage in both House and Senate bills will be through Medicaid -- a government run program.   The consequences of this feature of "reform" will be severe and far-reaching,  creating shortages in physician care and undermining access to medical services.  This quote from a doctor in South Dakota sums up the the wonderland we will all live in in the years ahead...

“If you end up seeing patients that cost you money to see, and you have no other ability to make up for that ... then you have to decide if you’re going to continue to see more Medicaid  patients,” said Tom Huber, MD, president-elect of the SDSMA in a March 2009 interview for KELO-TV. “If taking care of more people under
the Medicaid program means my business no  longer survives, then I’m doing a disservice to all the other patients, and that’s the dilemma that  physicians are facing.

You can read all about how shoving people into Medicaid could very well be the most cynical element of health care reform...

http://www.sdsma.org/documents/MedicaidSummerStudy.final.pdf  Read More & Comment...

And speaking of healthcare reform ...

12/17/2009 08:50 AM |

London, England (CNN) -- The entire genetic codes of two common types of cancer have been cracked, according to scientists, who say the breakthrough could unlock a new era in the treatment of deadly diseases.

Scientists at the UK-based Wellcome Trust Sanger Institute catalogued the genetic maps of skin and lung cancer and have pinpointed the specific mutations within DNA that can lead to dangerous tumors.

Researchers predict these maps will offer patients a personalized treatment option that ranges from earlier detection to the types of medication used to treat cancer.

The genetic maps will also allow cancer researchers to study cells with defective DNA and produce more powerful drugs to fight the errors, according to the the study's scientists.

"The knowledge we extract over the next few years will have major implications for treatment," Peter Campbell from the Wellcome Trust Sanger Institute said.

"By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments."

Scientists found that the DNA code for skin cancer contained nearly 30,000 errors and lung cancer DNA contained more than 23,000.

"These are the two main cancers in the developed world for which we know the primary exposure," Mike Stratton, from the Cancer Genome Project said.

"For lung cancer, it is cigarette smoke and for malignant melanoma it is exposure to sunlight.

"With these genome sequences, we have been able to explore deep into the past of each tumor, uncovering with remarkable clarity the imprints of these environmental mutagens on DNA, which occurred years before the tumor became apparent."

The study suggests that an error occurs for every 15 cigarettes that are smoked.

Scientists as part of the International Cancer Genome Consortium in other countries around the world are completing similar studies -- the UK is looking at breast cancer, the U.S. at brain, ovary and pancreatic cancer, and Japan at the liver.

Cancer is a leading cause of death worldwide and claims more than seven million lives each year according to the World Health Organization.

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Eshoo-ing FOBs

12/17/2009 08:21 AM |

Michael Hiltzik writes in today’s Los Angeles Times:

“The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar.”

Well, at least we know where he’s coming from.

Hiltzik continues:

“Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?”

He refers to the Eshoo Amendment.  He has a lot of problems with it – most notably the fact that it gives innovator products a dozen years of exclusivity.  While it’s hard to  take anyone who refers to follow-on biologics as “generics” seriously, a few points on why Mr. Hiltzik is completely wrong about the Eshoo language.

First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.

Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.

Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.

Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.

Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.

The complete Hiltzik column can be found here:

http://www.latimes.com/business/la-fi-hiltzik17-2009dec17,0,1929214.column

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Hating Joe Lieberman for Being Jewish

12/16/2009 10:37 PM |

His sin?  Not supporting the public "option" or a Medicare buy in..

Here is a partial list of (self) haters who go after Joe because he is Jewish...

One.

Two.

Three.

Four.

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Sweet Sanity

12/16/2009 07:56 AM |

Senator Dorgan’s amendment on drug importation goes down with a vote of 51-48 in favor. (60 votes were needed to prevail under a special rule.)

Senator Lautenberg’s amendment (importation with Secretarial certification) also went down (56-43).  According to the AP, “His proposal permits drug imports but adds a requirement that the U.S. government certify that the imports will be safe — a guarantee that Democrats and Republicans agree would be impossible to make.”

Sweet sanity.

Can we debate healthcare reform now?

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Hanukkah Melt Down on the Far Left

12/15/2009 11:20 PM |

In every generation....

http://spectator.org/archives/2009/12/14/hanukkahs-scrooge
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No Show on the Snyderman Show

12/15/2009 06:42 PM |

Goldberg News News Goldberg News, latest news about Goldberg News.

VIDEO: WHO IS SPYING ON YOUR PRESCRIPTIONS?
Dec. 15: Pharmaceutical companies are increasingly peeking at doctor's prescription pads, raising many concerns. Dr. Nancy Snyderman talks with consumer health advocate Marcia Hams and Robert Goldberg, a pharmaceutical industry advocate. (Other)
12/15/2009 23:20, msnbc



I didn't get a chance to be in this segment...I was in MSNBC's Green Room waiting to be led into the studio and saw the segment running.  A producer (?) rushed in and told me to run into another studio where I was miked for the segment.  Dr. Snyderman cut to commercial with a teaser about how kids who have a low sexual IQ are endangering themselves... (I was wondering if I had to shift gears and weigh in...)  In any event, another MSNBC person came and told me I missed the segment, thanks but no thanks..

Anyways,  what I would have said if had the chance.

First,  as Peter noted previously,  patient level data should not be used to market directly to patients.. That said, why is Ms. Hams organization proudly linked to a website from an insurance company that used patient prescribing data to bribe doctors to switch patients to generic drugs without telling them... 

http://www.crainsdetroit.com/article/20090301/SUB01/902269981

Moreover, data mining and contacting patients is critical to promoting compliance and personalized medicine. Lack of compliance with prescription regimens is a source of increased illness, mortality and medical costs.  It is a serious public health problem   The generic uber alles approach pushed by The Prescription Project likely adds to the problem since studies show that tiered formularies and generic mandates tied to higher co-pays with other drugs are associated with increased illness.
 
http://www.managedcaremag.com/archives/0408/0408.drugtier.html

  But even allowing drug companies to use data that patients and doctors voluntarily give is grounds for legal and political attacks.  No surprise.   Ms. Hams organization is lawsuit driven.  It's Prescription Access Litigation Project generates revenue by suing drug companies and has partnered with tort law firms whose senior partners are now in the slammer for sleazy and illegal practices.  Talk about putting profit ahead of patient wellbeing..

http://www.prescriptionaccess.org/press/pressreleases?id=0010

money.cnn.com/magazines/fortune/fortune_archive/2006/11/13/8393127/index.htm


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Importation conundrum

12/15/2009 09:35 AM |

Today every member of the Senate Democratic Caucus is headed to the White House for yet another pep talk from President Obama in a last-ditch effort to secure passage of some kind of health care bill.

In the last couple days Senator’s Dorgan drug importation amendment has proven a major stumbling block to passing a health care bill.

Whether or not Senator Dorgan is amenable to compromise remains to be seen. This puts President Obama in an incredibly difficult spot. On one hand, the more liberal members of his party are absolutely determined to squeeze more out of those evil pharmaceutical companies. But PhRMA struck a deal early on in this process with the Obama administration and has heavily assisted in promoting the president’s health care agenda.

Will President Obama risk creating another obstacle to passing a bill by challenging Dorgan, or does he throw PhRMA under the bus?

As for Dorgan, if he is truly interested in cost control, then why not focus his efforts on the genuine waste in the system (particularly in Medicare and Medicaid) instead of attacking an innovative industry?

Could it be his only reason for pushing this perpetually nonsensical proposal is that the pharmaceutical industry makes for a politically convenient target that distracts from the really asinine aspects of the Senate bill?

Senator Dorgan needs to ask himself three simple questions:

1. Do prescriptions drugs save the health care system money in the long-term by rendering surgeries and lengthy hospital stays unnecessary?

2. How would Canada respond to US legislation allowing for importation of drugs?

3. Is importing drugs from Canada safe?

On the issue of safety, The Hill reports on FDA Commissioner Margaret Hamburg’s letter to Senator Sam Brownback:

The Dorgan amendment “as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns,” Hamburg wrote in a letter to Sen. Sam Brownback (R-Kan.), related to preventing counterfeit or mislabeled medicines from being sold in U.S. pharmacies.

“We commend the sponsors for their efforts to include numerous protective measures in the bill that address the inherent risks of importing foreign products and other safety concerns relating to the distribution system for drugs within the U.S.,” Hamburg wrote, while emphasizing the legislation does not achieve those objectives.

What was Dorgan's response to the FDA's statement?

He called it "completely bogus."

Wow, now there’s a measured response.

If Dorgan loses re-election next year, maybe he can look into a future position as FDA Commissioner. He apparently has the credentials for the job.

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Women and Health Care reform

12/15/2009 09:30 AM |

Prior to the passage of the House health care bill, Speaker Nancy Pelosi said the following on the House floor:

“For all Americans, this legislation makes a big difference: no discrimination for pre-existing medical conditions, no dropped coverage if you are sick, no co-pays for preventive care. There is a cap on what you pay in but there is no cap on the benefits that you receive. It works for seniors closing the donut hole, offering better primary care, and strengthening Medicare for years to come. It works for women preventing insurance companies from charging women more than men for the same coverage. No longer will being a woman be a pre-existing medical condition.”

As I pointed out back in September, it is not the same coverage. Men and women share different medical risks. Insurance premiums are based on those risks. Just as men generally pay higher premiums for both auto and life insurance, women generally pay higher health insurance premiums. That is price discrimination based on financial risks.

But the point of this post is not to rehash that issue.

CMPI Vice-President Bob Goldberg posed the following question in his recent piece in the American Spectator:

Is health care reform designed to discriminate against women?

It’s a question worth asking. Bob cited the cosmetic surgery tax in the Senate health care bill as proof of the legislative assault on women.

Planned Parenthood protested Senator Ben Nelson’s abortion amendment holding signs that read, "Listen up senators: Women's health is not negotiable."

However, Planned Parenthood and other women’s groups are nowhere to be found on the issue of a cosmetic surgery tax. Something tells me if a tax was proposed on abortion procedures, they’d be out in full force speaking on behalf of women’s health.

A cosmetic surgery tax tinkers with one of the more productive sectors of the overall US health care system – more productive in the sense that there is a 93 percent satisfaction rate among patients who undergo cosmetic medical procedures. Moreover, inasmuch as patients typically pay out of pocket for many cosmetic procedures the sector has seen downward pressure on prices on account of the highly competitive market.

The primary problem with this tax is the government fails to make any distinction between a truly “cosmetic” procedure and a procedure for legitimate medical reasons. Senator Tom Coburn (R-OK) recently warned about this shortcoming saying, “They're going to tax having your breast rebuilt after your breast is taken off because it is elective plastic surgery. We're in trouble as a nation because we've taken our eye off the ball.”

The failure to distinguish between cosmetic procedures for medically elective and medically necessary reasons aside, the tax is still a terrible idea. Perhaps even more troubling, a tax on cosmetic procedures would be heavily borne by women. Indeed, 86 percent of cosmetic surgery patients are female. Contrary to popular opinion, this tax would not fall on the wealthy. About 70 percent of these patients earn less than $60,000 a year. Cosmetic surgeon Stephen Greenberg notes, “The misconception about people having cosmetic-surgery procedures is that they're wealthy. But it's . . . the average person who wants to feel better about themselves.”

Another significant shortcoming of this proposal is the belief that a tax will produce the revenues anticipated. It is important to recognize that New Jersey is the only state that taxes cosmetic surgeries and that tax has produced nearly 60 percent less revenues than originally projected. If New Jersey’s experience is any indication, the government will wind up investing more money for each dollar collected.

So does this tax discriminate against women? You make the call.

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Kohl Comfort

12/15/2009 08:06 AM |

Senator Herb Kohl’s proposal to ban the collection of doctors' prescription records for marketing purposes is unlikely to be included as part of the Senate's overall health reform bill. A Kohl staffer said the change was not likely to come up for a vote or be included as part of a package of changes to be offered later by Senate Majority Leader Harry Reid.

While Kohl's ban is unlikely now, supporters will continue to push for the measure in other ways, the senator's staff member said. "We hope it happens at some point."

I don’t agree.

While physician-prescribing data shouldn't be available for marketing purposes, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.

Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."

The AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered legislation on either the state or federal level now or in the future.

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Rolling Snake Eyes on Importation

12/14/2009 08:23 AM |

Bouquets to Senator Bob Menendez (D. NJ) who had the following to say about legalizing drug importation, “Health-care reform and lowering costs does not mean we should roll the dice with the health and safety of the American people.”

And Brickbats to Senator Byron Dorgan (D, ND), who said he will object to any amendments to the Senates healthcare reform bill until objections are lifted to a vote on his importation proposal.

“I fully expect to get a vote and I expect we will win,” Dorgan said.

But at what cost to drug safety and the public health?

According to the FDA -- in a December 8th letter to Senator Sam Brownback (R, KS) -- the Dorgan scheme doesn’t address “significant safety issues related to confusion in distribution and labeling” of foreign and domestic drugs.

Dorgan said the FDA letter overlooks “dramatic new safety provisions” in the legislation and said political concerns were prevailing in the decision to delay.

Except there aren’t any new dramatic new safety provisions.

“There are people walking on egg shells” out of concern that the drug industry will oppose the bill, Dorgan said.

Not so.  The concern is over drug safety. And appropriately so.

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The Post Obamacare World

12/13/2009 04:22 PM |

Someone will have to be clean up the mess... the private sector to the rescue...

http://online.wsj.com/article/SB10001424052748704240504574586260904799386.html?mod=rss_Today%27s_Most_Popular  Read More & Comment...

Heavy Bleeding

12/11/2009 09:25 AM |

Inside-the-Beltway chatter has it that some members of the Republican caucus are getting ready to support Senator Dorgan’s drug importation amendment in the misguided belief that it will serve as a healthcare reform “poison pill.”

Not.

The theory is that if the Dorgan Organ passes, then Big Pharma will throw its weight against the legislation.

Not.

This strategy is ill-considered for a multitude of reasons. Let me mention three:

(1) Volume.  Big Pharma has more immediate big fish to fry, most notably protection of the Non-Interference Clause and a future with many more Medicare-eligible seniors having their on-patent prescription medicines paid for via Part D.  And filling the doughnut hole (another part of “the deal”) is a crucial part of this strategy.  Immediate (and likely permanent) increases in volume trumps the many negatives of drug importation.  Short sighted?  Certainly.  But these are public companies with patent expiry issues, reimbursement worries and questionable pipelines. Big Pharma – while against drug importation – won’t go to the mat at this stage in the process.

(2) Price Controls. Drug importation is a big shove down the slippery slope towards pharmaceutical price controls.  In fact, it is the importation of foreign price controls at worst and reference pricing at, well, at worst.  And don’t kid yourself, that’s the real reason why folks like Rahm Emmanuel (who promulgated similar legislation when he was in Congress) and Bernie Sanders (the Senator from Ben & Jerry’s) support this idea.  Every government study shows that importation schemes don’t save us money.  So, why pursue this silly soundbite strategy if not for more nefarious purposes? Voting “for” drug importation to kill flawed healthcare reform legislation is like having a hysterectomy to control menorrhagia.  

(3) Safety.  Most importantly – MOST IMPORTANTLY – is the fact – THE FACT – that drug importation makes our prescription medicines supply less safe – LESS SAFE.  And that is just not acceptable.  Not under any circumstances.

A vote for drug importation minus Secretarial Certification is a very big mistake – regardless of motivation.

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