Northern Exposure

05/28/2010 08:30 AM |

From the Toronto Star:

 

Ontario is open to tinkering with drug co-payments for seniors and others on taxpayer-funded pharmacare programs as it looks for ways to curb the rapidly increasing cost of health care, Health Minister Deb Matthews says.

 

Doctors could also see more efforts to nudge them from a fee-for-service payment model to salaries, Matthews said Thursday in the wake of a TD Bank report warning of the “serious fiscal challenges” facing medicare.

 

The report said half of government spending on drugs goes to seniors with higher incomes, and suggested the wealthiest seniors get no drug coverage – an idea Matthews flatly rejected.

 

But while the minister said taxpayer-funded drugs for seniors, the disabled and welfare recipients would continue under a Liberal government, co-payments for seniors could change based on their income levels.

“We have a bit of that now. There are different premiums and co-pays for people at different income levels,” Matthews told reporters.

 

“Have we got that right? Is it something we should look at? Sure, I think it’s something we can look at.”

Under the current system, senior citizens with incomes above $16,018 a year and couples with a combined income above $24,175 now pay their first $100 in prescription costs, and after that may pay up to the maximum of $6.11 in dispensing fees for each prescription.

 

Seniors with incomes below those levels may be asked to pay up to $2 for each prescription.

 

The TD report called for “bold” changes because at the current rate of growth, health care costs would eat up 80 per cent of the government’s program spending by 2030, compared with 46 per cent now and 30 per cent in the 1990s.

 

“We need to have the conversation about the future of health care in Ontario,” said Matthews, echoing a line she has been using for months as the government has moved, as first reported in the Star, to tie hospital funding to services provided to patients and to link pay for hospital executives to patient outcomes.

 

Doctors should be paid more on a salary basis instead of on a fee-for-service basis to make them “better able to consider the cost-effectiveness of their treatment decisions,” said the TD report by well-known economists Don Drummond and Derek Burleton.

 

“I think that is something we should continue to really look at,” said Matthews, pointing out that many doctors on family health teams and in hospital emergency rooms are now on salary.

 

Speaking for doctors, the Ontario Medical Association said it is reviewing the TD report and recognizes the sustainability of health care funding is a “crucial issue.”

 

“We know that there is still more work to be done,” association president Dr. Mark MacLeod said in a statement, welcoming a public debate on reforming the system while protecting the interests of patients.

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From iPad to IPAB

05/27/2010 08:11 AM |

Is there an American who doesn’t know what an iPad is?  More importantly, there are too many who don’t know about IPAB – the newly formed Independent Payment Advisory Board.  That’s about to change.

Read all about it in this new op-ed appearing in today’s edition of the Atlanta Journal-Constitution.

Medicare payment board needs a fix

By Peter Pitts
May 26, 2010

Those who opposed the health care bill are debating whether “repeal and replace” should be the clarion call in the coming election. Regardless of how this debate turns out, those in favor of doing better should focus their immediate attention on identifying and fixing the most harmful parts of the bill. The new Independent Payment Advisory Board, or IPAB, should be a top target.

The bill that passed restructures the existing federal agency responsible for bringing down Medicare costs — the Medicare Payment Advisory Commission, or MPAC — and turns it into the IPAB.

MPAC was a group of medical experts appointed by Congress that provided nonbinding recommendations on ways to cut expenses and increase revenues in the Medicare program.

The changes embodied in the IPAB are meant to make the agency more independent and to skirt the political hurdles that have stalled cost-control efforts in the past. Board members will now be appointed by the president. And the IPAB’s policy recommendation automatically will be instituted unless Congress overrides them.

The goal of reigning in Medicare expenses is a worthy one. As is, the program’s costs are spiraling out of control: Medicare is projected to accumulate a $38 trillion budget shortfall during the next 75 years.

But this version of the IPAB likely will prove ineffectual. For one, it doesn’t have any authority over the biggest cost-drivers in Medicare.

Medicare Part A, for instance, is so expensive its reserves will be empty by 2017, according to the Medicare Trustees. Part A covers in-patient hospitals stays. By 2035, the program’s revenues will only finance about half of promised benefits.

Medicare Part B, which covers out-patient services, has similar cost problems. Administrators just raised Part B premiums on nearly a quarter of beneficiaries because expenses have gotten so high. And an analysis from the Congressional Research Service found that without substantial hikes in Part B premiums, the program’s finances are “at risk of exhaustion.”

Yet the IPAB has no power over Part A or Part B. They’re both left to keep hemorrhaging money, soaking up taxpayer dollars and compromising the economy. Lawmakers need to push to expand the agency’s purview so it can address the real causes of Medicare’s ballooning costs.

There’s also a risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the board room, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs.

The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements. Technically, Congress can cancel any such changes by passing a joint resolution within a month of their proposal. But Congress is so fractured that it’s very unlikely there will be the political will for such a move.

There need to be substantive checks against the IPAB decisions. And seniors need to be guaranteed representation during the policymaking process.

If left unaltered, Medicare could literally bankrupt this country. This IPAB is a step in the right direction, but it needs improvement. By pushing for some simple, commonsense modifications to the IPAB, those in favor of doing better could substantially bring down health care costs and improve coverage for millions without compromising their principles.

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NICE Exfoliation

05/26/2010 07:45 AM |

According to a report in London’s Daily Express ...

 

LEADING cancer experts were furious last night after yet another drug to extend the lives of patients (Nexavar) was refused on the NHS.

 

The decision by the Government's drugs rationing body NICE means patients with advanced liver cancer are the only ones in Europe not to have access to the sole treatment that could help them.

 

In some cases, the drug can enable sufferers to live for several years. Experts said there is no good reason why the hundreds of people who require the treatment should be denied the drug.

 

Their outrage was further fuelled yesterday by the disclosure that one NHS Trust is offering a £22,000-a-year salary to someone to remove hairs from transgender males who want to appear more feminine.

 

Karol Sikora, professor of cancer medicine and medical director of CancerPartnersUK said: "Today's decision is yet another kick in the teeth for patients, their families and the medical community.

The full Daily Express story can be found here:

http://www.dailyexpress.co.uk/posts/view/177208

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Adjusting Views on Pathway Genomics

05/25/2010 02:52 PM |

I tend to agree with the views expressed by Steve Murphy over at   thegenesherpa.blogspot.com/.       My previous posts were a reaction, not a thoughtful response to, the FDA decision to ask Pathway a lot of questions that address whether the public benefits of distributing gene tests through Walgreen's (still a good business model I believe) outweigh the risks and whether the tests are both reliable and easy to interpet and apply in a clinical setting. 

I sympathize with those who say "it's my DNA" and I should do what I want with it but if you apply that logic to anything in life without some guideposts and limits, it leads to anarchy.   Saying it's "my DNA" is actually like saying it's my way of doing arithmetric.   If there is no way to validate my conclusions and apply them to the real world in a standard format chaos ensues.

My feeling, after reading Steve's post and discussing the launch with real doctors and geneticists, is that the  path for Pathway needs to be more clearly marked to lead to personalized medicine but that it should be a path in the future.

Here is Steve's  thoughtful and science-based take: thegenesherpa.blogspot.com/

Monday, May 24, 2010

DTC Genomics reviewed in Genetics in Medicine

I just received the May issue of Genetics in Medicine, only 24 days late. But it caught my attention for several reasons.

The Sherpa Says: Doctors go to medical school for 4 years, then go onto residency for 4-8 years and some do fellowship for another 2-5 years. And then we give risk assessment and diagnose and treat. Why do people forget that? Oh and we first operate under the principle of First Do No Harm. What doesn't Mr Goetz get about that
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Poetic Justice for Andrew Wakefield

05/25/2010 02:32 PM |

http://health.usnews.com/health-news/blogs/on-parenting/2010/05/24/study-early-childhood-vaccines-dont-damage-kids-development

On Parenting

Study: Early Childhood Vaccines Don't Damage Kids' Development

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Many parents worry that the vaccines recommended for a baby in the first year of life are just too much too soon for an infant's immature immune system. Those fears have fueled a growing trend of parents delaying or refusing to vaccinate their babies. But a new study in Pediatrics examined the long-term effects of delaying vaccines and found that children whose parents refused or postponed vaccines did no better than children who were vaccinated on time, when tested on things like speech, language, achievement, fine motor skills, attention, and general intellectual function seven-to-10-years later.

The news comes the same day that Andrew Wakefield, a British doctor who did more than any one person to propagate the belief that vaccines cause autism, was barred from practicing medicine in Britain. Wakefield's 1998 study, published in The Lancet, fingered the measles, mumps, and rubella (MMR) vaccine, as a cause of autism, though he looked at just 12 children. In February, The Lancet retracted his study, and Britain's regulatory group said Wakefield had been "dishonest" and "misleading" in conducting the research, including failing to disclose that he was working with lawyers who sought to sue vaccine manufacturers. Wakefield has moved to the United States.

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Generic Preemption?

05/25/2010 08:23 AM |

WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.

Generic drug makers are seeking to preempt a product liability lawsuit by a woman who allegedly developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan.

The woman alleged the drug posed more serious risks than drug makers indicated on their labels.

A trial judge had dismissed the woman's lawsuit but an appeals court reinstated it last year.

The generic drug companies, including Teva Pharmaceutical Industries Ltd. ( TEVA) and Mylan Inc.'s (MYL) UDL Laboratories, said the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label.

In ruling against the generic drug makers, the St. Louis-based 8th U.S. Circuit Court of Appeals cited a 2009 Supreme Court decision against Pfizer Inc.'s (PFE) Wyeth unit that said Food and Drug Administration drug regulations do no protect a drug company from being sued under state law over drug labeling.

The 8th Circuit said Congress could have crafted a provision that preempted drug-labeling lawsuits against generic drug companies but chose not to do so.

In a short written order, the Supreme Court asked the U.S. Solicitor General's office to express the Obama administration's views on whether the court should consider the drug makers' appeal.

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The New 10 Commandments

05/25/2010 08:14 AM |

Take two tablets and call me in the morning.

The AMA has released its “Health Insurer Code of Conduct Principles.”  There are 10 of them, but let’s focus on #5:  “Medical Necessity.”  Here’s what the AMA has to say:

Medical care is “necessary” when a prudent physician would provide it to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is:  (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or the convenience of the patient, treating physician, or other health care provider.

And further down:

Health insurers must not use financial incentives that discourage the rendering, recommending, prescribing of, or referral for medically necessary care.

And finally:

No care may be denied on the grounds that it is not “medically necessary” except by a physician qualified by education, training and expertise to evaluate the specific clinical issues.

“Health insurers should provide access to necessary health care, protect the patient-physician relationship and accurately process medical claims, but too often they are an obstacle,” said AMA President J. James Rohack, M.D. “The new Health Insurer Code of Conduct Principles will help protect patients and physicians from questionable insurance practices by holding the health insurance industry accountable.”

The AMA’s full statement along with a link to their new 10 Commandments can be found here.

And, let’s not forget who the nation’s biggest health insurer is – that’s right, Uncle Sam.

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e-mail de cachet

05/24/2010 08:54 AM |

Badges?  We don’t need no stinking badges.

Compliance through secret commination is a bad idea that may very well be an unintended consequence of the FDA’s nascent “Bad Ad” program.

Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber?  Really?  Whatever became of transparency.  What’s next? Anonymous adverse event reporting?

The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law.  In the Old West this was more generally referred to as a posse, or worse – a lynch mob.

For more on this issue, see this new article from Advertising Age.

Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy.

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Olio Folio

05/21/2010 08:19 AM |

To CER with Love

WellPoint has released guidelines for the submission and evaluation of comparative effectiveness research that it will use in reviewing drugs for its formulary.

The guidelines state that, "while randomized, controlled clinical trials remain the gold standard for producing reliable efficacy and safety data, WellPoint recognizes that there are circumstances in which RCTs may not be sufficient alone for decision-making. Accordingly, a well-conducted CER or observational study may complement RCT-based information by providing effectiveness data, or data on outcomes achieved in a 'real-world' setting."

The guidelines explain that "observational studies provide information regarding product safety, cost-effectiveness, budget impact, and the validation of key assumptions used in cost-effectiveness and budget impact models. Furthermore, WellPoint may want to gain more insight regarding drug comparisons not found in the literature, such as off-label use and use in sub-populations."

Should a drug sponsor desire to submit results of a CER study, the guidelines list 20 specific criteria relating to the study for which information should be included. These are to include not only details of the study design, patient population and results, but a discussion of potential bias, the limitations and validity of the conclusions, and the relevance of the findings to WellPoint's patient population.

Food for Thoughtless

From CQ: "Sen. Byron L. Dorgan of North Dakota has his eye on the food safety bill as a vehicle to revive his proposal to allow the importation of US-made prescription drugs from Canada and other countries." Dorgan "says he is determined to press for another floor vote on the 'reimportation' issue when the food safety measure (S 510) moves to the floor. The bill was slated for possible action this month, but has been nudged aside in the rush to complete a fiscal 2010 war supplemental bill and a package of tax cuts and social spending by the Memorial Day recess." Notably, "Majority Whip Richard J. Durbin of Illinois says he's concerned that the Dorgan proposal could complicate the food safety bill." Um, yeah.

And a Pair of Tube Socks

Via AFP comes the report that British supermarket chain Asda plans to sell cancer drugs at cost price and called on its peers who make massive profits on the treatments to follow suit.

The group, owned by the world's biggest retailer US supermarket giant Wal-Mart, said its initiative follows the success of a similar scheme by Asda for in-vitro fertility (IVF) treatments.

"The crippling cost of paying privately for cancer treatment has forced many people to spend their savings or even re-mortgage their house to pay for these essential drugs," said John Evans, superintendent pharmacist at Asda.

"We are the first retailer to recognise this injustice and to do something about it and we are calling on other retailers to follow our lead."

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The fault, dear Brutus ...

05/20/2010 08:16 AM |

Blame the FDA. It’s a staple of industry communications that when a company receives a complete response letter. And it’s easy to do since such communications are “commercial confidential.” Not that the agency doesn’t often deserve blame – but there are generally two sides to every story and complete response letters are rarely (if ever) released to the media by the recipient.

Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency. Easier said than done? Sure. But let’s stop with the lame “We’ll make FDA angry” excuses.

Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known.
And let’s face it, that can quickly slip/slide into spin. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. Yet.

Yesterday, the FDA’s Transparency Taskforce recommended that the agency release more information about medical products and foods, including letters sent to companies about whether a product is approved or rejected. That’s right – the public release of complete response letters.

Another recommendation calls for the FDA to release safety information in cases where companies withdraw an application for a drug or medical device and a third suggests the agency release information about drugs for rare diseases, known as orphan drugs, in cases when the application was withdrawn for business reasons and not safety reasons. The agency could state that the proposed drug, if approved, would represent an advance for the treatment of a particular disease.

Don’t like these ideas? Blame the FDA? Perhaps. But the fault, dear Brutus …
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BIO Break?

05/19/2010 08:10 AM |

Interesting overview of healthcare reform on the biologics business in the May edition of Nature Biotechnology.  Here's a sample:

"The healthcare reform bill ... includes key provisions that will lead to new and improved treatments, cures and cost-savings for patients, while driving job growth in our industry and maintaining our nation's global leadership in biotech innovation," says Jim Greenwood, president of the Biotechnology Industry Organization (BIO) in Washington, DC.  Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) in New York, agrees:  "This legislation will have a huge impact on biotech companies -- the  most affected of any industry."

And here's how the article ends:

Says Pitts of CMPI, "Industry lobbied hard for a good bill, but this bill is flawed in so many ways."  However, he adds, "It's time to realize that it's no longer just about selling drugs, but for providing healthcare -- and companies must walk the walk."

For the entire article, click here.
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Orszag the Oracle

05/19/2010 01:43 AM |

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Gene Acres

05/18/2010 08:54 AM |

The NIH is creating a public database that researchers, consumers, healthcare providers, and others can use to search for information submitted voluntarily by genetic test providers. The Genetic Testing Registry aims to enhance access to information about the availability, validity, and usefulness of genetic tests.

Currently, more than 1,600 genetic tests are available to patients and consumers (but not at WalGreens), but there is no single public resource that provides detailed information about them. The Genetic Testing Registry is intended to fill that gap.

The registry project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information, part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011.

(Psst -- just don't tell the FDA.)

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Breathing Causes ADHD

05/17/2010 02:21 PM |

An "study"  (i.e. torturing data until it tells you what you want to conclude) showing that pesticides cause ADHD was widely reported in the news today.

Like previous studies claiming a link between cell phones, constipation, food additives, etc., this one is designed to provoke fear and not inform. 

I won't go into the many problems with this study, let alone the fact that it correlated an ADHD diagnosis with undetectable amounts of phosphate based pesticides in a kid's pee.   (How can you -- absent clinical markers -- measure something that is statistically undetectable?)  But how about these four facts to put this piece of garbage into context:

1.   The prevalance of ADHD, once adjusted for diagnostic accuracy, is about the same in the US as it is in Europe or South America. 

2.    Pesticide use in the US has decreased since 1970.   Meanwhile prevalence rates have remained the same or increased slightly. 

3.   ADHD can be geographically clustered and found more commonly in single parent families.     Where you live and your family life are associated with ADHD though the relationship is certainly not causal.   

4.    ADHD is highly heritable... up to 75 to 90 percent of ADHD among kids is associated with shared genetic traits...

5.   Articles reporting on the "study"  quote one of the authors as saying that the pesticides might cause ADHD because " the primary action of organophosphates is to inhibit acetylcholinesterase, and disruptions in cholinergic signaling are thought to occur in ADHD."  However, what little work on  acetylcholinesterase levels and ADHD suggest that higher serum levels are associated with ADHD, not lower.  If pesticides are inhibitors of serum production then they should be used as medication...   Indeed, inhibiting these levels is how Alzheimer's and autism can be treated...  

Has anyone in the media taken the time to do anything but spread the stupidity and fear?  Of course not.  


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FDA's Pathway Roadblock

05/17/2010 11:14 AM |

The FDA scotched the Pathway and Walgreens partnership by asking Pathway to prove it didn't need FDA approval as a medical device.  Someone should explain to me how gene tests are a medical device..I guess soap and bathroom scales are also medical devices (David Kessler once said the former was!) and should have FDA approval of some sort.   Meanwhile, clinical labs that are part of programs designed to test, diagnose and sell quackish treatments abound...

www.sciencebasedmedicine.org/

The lame protectionist statement from the genetics counseling trade group sounds a lot like the whining from HIV clinics who opposed home HIV tests (protecting patients, not their monopoly on testing).  "National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."

Really?  Seems to me that it will lead people to contact doctors and make lifestyle changes...just as the spread of the home HIV test.  Paternalism persists. 

I guess the agency has nothing better to do...

articles.latimes.com/2010/may/13/business/la-fi-dna-kits-20100513




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Into the Valley of Death

05/17/2010 09:03 AM |

A last gasp of sanity from Newsweek:

From 1998 to 2003, the budget of the NIH—which supports such research at universities and medical centers as well as within its own labs in Bethesda, Md.—doubled, to $27 billion, and is now $31 billion. There is very little downside, for a president or Congress, in appeasing patient-advocacy groups as well as voters by supporting biomedical research. But judging by the only criterion that matters to patients and taxpayers—not how many interesting discoveries about cells or genes or synapses have been made, but how many treatments for diseases the money has bought—the return on investment to the American taxpayer has been approximately as satisfying as the AIG bailout. "Basic research is healthy in America," says John Adler, a Stanford University professor who invented the CyberKnife, a robotic device that treats cancer with precise, high doses of radiation. "But patients aren't benefiting. Our understanding of diseases is greater than ever. But academics think, 'We had three papers in Science or Nature, so that must have been [NIH] money well spent.'?"

More and more policymakers and patients are therefore asking, where are the cures? The answer is that potential cures, or at least treatments, are stuck in the chasm between a scientific discovery and the doctor's office: what's been called the valley of death.

And wither the Reagan/Udall Foundation?

Just sayin ...
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Gene Genie

05/17/2010 08:12 AM |

According to the Pink Sheet, “A particularly public pre-emptive stance” by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans this week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move signals no changes to its enforcement policy for laboratory-developed tests.

Walgreens' decision came after FDA sent Pathway a letter questioning the approval status of the tests and after Alberto Gutierrez, director of FDA's Office of In-Vitro Diagnostic Device Evaluation and Safety, provided explicit statements to national media outlets that Pathway was flouting FDA regulations.

The firm, which already sells similar sampling kits and services to consumers over the Internet, says it does not need FDA go-ahead because the offerings qualify as traditionally non-agency-regulated laboratory-developed test services and the company is not making diagnostic claims that require FDA oversight.

But, per Gutierrez, the crucial factor is that once a patient, rather than a physician's office, is tasked with taking the sample, all arguments that a product is not an FDA-regulated IVD go out the window.

He added, however, that there is no need for the agency to buck precedent on lab-developed test oversight to go after Pathway, or, likely, other companies that sell similar genetic screening services over the Internet, including 23andMe and Navigenics.

Hm.

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From the Taste of One’s Own Medicine Department

05/14/2010 04:11 PM |

Mr. Pot meet Ms, Kettle.

The Food and Drug Administration has again denied Teva's citizen's petition asking the agency to block approval of a generic version of its Copaxone multiple sclerosis treatment.

 

The Israeli drug giant filed the letter in November after its initial attempt failed earlier in 2009. The FDA rejected the second petition for the same reason as the first, because it would be "premature and inappropriate" to grant Teva's requests, but gave a detailed response that rejects many of the company's arguments against the generic approval.

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Dublin Down

05/13/2010 08:30 AM |

The Irish Medicines Board has decided to support generic substitution.

According to IMB Chief Executive Pat O'Mahony, "While the IMB ... has no involvement in product pricing structures or agreements, we welcome any initiative that improves value for money and ensures the continued provision of innovative medicines as they become available.”

“Value” to whom?  And, last time we looked, such a policy actually strikes against innovation.

Mr. O’Mahony would be wise to remember the old Irish proverb, “Everyone is wise until he speaks.”

In the meantime, just across the Irish Sea in Great Britain, our regulatory cousins at the MHRA have are concerned about generic substitution as well – specifically for oral tacrolimus. The MHRA says it has received 12 case reports of prescribing or dispensing errors associated with the immunosuppressant, oral tacrolimus, which has a narrow therapeutic index.

There are three different oral formulations of tacrolimus available in the UK, but they are not interchangeable, and switching between them should only be performed under the close supervision of a transplant specialist, the MHRA recommends. The reports have included four cases of acute rejection reaction, three cases of increased drug levels, and two cases of increased creatinine.

Generic drugs are a hugely important part of the healthcare paradigm – but bioequivalence cannot be ignored.

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Pathway Genomics and Walgreens: New Path to Personalized Medicine?

05/12/2010 11:22 AM |

Anti-pharma Luddites -- in an ideologically induced haze -- can't decide whether to call for additionally safety studies (PPIs) or to call them off (Avandia) consistently ignore the value of using gene testing to personalize drug response and optimize care.  The reason is obvious.  Keeping people in the dark about whether a medicine will help a lot or a little, or help or hurt breed uncertainty and uncertainty is the wellspring of fear and fear is what allows the Luddites to continue their very profitable campaign against commercialization.  If people know or knew the relative risks and benefits of medicines, then the fearmongering would be ineffective..

Hence, the launch of Pathway Genomics gene test for drug response and disease risk via Walgreen's (and CVS) is most welcome.  From what I can tell, Pathway's approach is medically and scientifically responsible.  Their scientific management is top-notch and careful.  And spreading the knowledge of what drugs or doses can help or hurt is, like cholesterol levels, information that can advance the public health.

But of course it will have it's critics.  And enemies. 

Which is why the FDA "investigation" of the Pathway product - now -- after it has been on the market for over a year should raise eyebrows.  Given Peter Lurie's connection with Luddites like Goozner, Wolfe, Mahar, Diane Zuckerman etc. it would and will be interesting to see how these "experts" who of course have no bias whatsoever weigh in on the Pathway-Walgreen's alliance.  And it will be interesting to see if the FDA, which seems to be involved in everything but advancing The Critical Path and regulatory science these days,  makes a federal case out of a science-based effort to educate patients about the important role genes and genetic response plays in response to medicine and prospective health.

I have a hunch how Maggie Mahar will react. 

www.pathway.com/more_info/health_test#q6
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