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Duck and Cover

  • 08.09.2007
Senator Grassley is proposing legislation that would have pharmaceutical companies disclose payments made to physicians for just about eveything. The Senator wants "transparency."

And transparency is a good thing.

Should Big Pharma be disclosing payments or should the burden of transparency be on the physician? Good debate. But here's a bigger question -- if transparency is a good thing when it comes to Big Pharma's payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits?

Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?

It's not in the Grassley bill.

Or what about transparency regarding how some state governments are leveraging a physician's prescribing habits via state regulations?

Also not in the Grassley bill.

It seems the Grassley is always greener when it comes to slamming Big Pharma -- but that everyone else with an open wallet (or a tight wallet in the case of state governments) gets a free pass.

If transparency is good for the goose then it's good for the gander.
Great piece in the South China Post by Jerry Norris of the Hudson Institute on how the left, again, will let poor people die in order to kill drug companies and capitallism. I guess that's their version of a trade off.

It's politics vs science in global health

July's meeting of the International Aids Society, in Sydney, was another measure of how the global fight against HIV/Aids is falling short. Despite US$31 billion spent since 2003, infection rates continue to rise and political agendas are tragically undermining sound science.

The global health community anticipates having some 2 million people on antiretroviral treatment by the end of the year. The World Health Organisation is promoting a target of 10 million Aids patients under treatment by 2010 - independently of evidence-based medicine, because we know virtually nothing about patient outcomes.

There is a disturbing lack of medical records, and no cost-benefit analysis for each therapy has ever been done by the WHO or its global partner agencies.

Most donors treat people because they are poor rather than because they are sick. Science has been set aside in favour of reaching arbitrary targets as quickly and cheaply as possible, yielding numbers for politicians rather than medical records for clinical review.

Laurie Garrett, a senior fellow at the United States-based Council on Foreign Relations, sees bigger lessons in the global HIV/Aids effort's failures. With so much money that has so many strings attached, all focused on a single disease, we are systematically hobbling low- and middle-income countries' ability to improve their overall health systems.

The international political left has been cynically using the global Aids effort towards its own ends, particularly around basic international drug patent rules. It advocates theft rather than partnership in drug pricing policy, and sees the private sector as the enemy. Major non-governmental organisations, such as Oxfam, have made strange bedfellows to further this political cause.

Oxfam and its allies are persistently working to have the military dictatorship in Thailand become the first government to break patents on antiretroviral and other chronic disease medications. The dominoes are in place to fall, and the impact on new Aids drug development could be devastating.

These political battles are not supported by science, and are sand in the wheels of the mechanisms necessary to overcome HIV/Aids and every other major health threat.

The left must give up its incessant crusade against market economics; the private sector must commit to health care improvements as a strategic investment over the long-term, not mere charity. Deals on drug pricing should not be political footballs but fall under an agreed-upon approach which supports the rule of law, ensures safety and prevents counterfeit products from entering the market.

The lesson of HIV/Aids is a serious warning sign about the giant potential that global public health has, for ill or for good, depending on how we approach it. Failure to make serious progress will have enormous consequences.
A great example of evidence based medicine put to great use....

Doctors Paid To Switch Patients To Generic Drugs
Incentives Raise Ethical Questions


BOSTON
Team 5 Investigates discovered that health insurers are giving doctors incentives, sometimes in cash, to switch patients to generic brands.

NewsCenter 5's Janet Wu reported Wednesday that the payments are legal, but health care experts said they clearly raise ethical questions if patients are not told the reasons behind the switch.

Much of the controversy centers on the cholesterol drug Lipitor, which is the best-selling medicine in the world. It is currently under a patent and does not have a generic version. Thousands of Massachusetts patients recently discovered their insurer won't pay for it anymore or that their out-of-pocket cost has skyrocketed. Other patients told Team 5 Investigates they were switched by their physicians with little explanation. Earlier this year, Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.

“Without saying to the patient, ‘I have a financial incentive in making this decision, which goes along with my professional incentives to do what's right for you,’ it's unethical,” said professor Regina Herzlinger, of Harvard Business School . “It's a clear conflict of interest.”

Team 5 Investigates asked Blue Care Network of Michigan if patients were told of the financial kickback.

Earlier this year, Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.

“Without saying to the patient, ‘I have a financial incentive in making this decision, which goes along with my professional incentives to do what's right for you,’ it's unethical,” said professor Regina Herzlinger, of Harvard Business School . “It's a clear conflict of interest.”

Team 5 Investigates asked Blue Care Network of Michigan if patients were told of the financial kickback.

A spokeswoman said "not specifically."

In Massachusetts , financial arrangements for switching patients from Lipitor are less blatant, but they do exist.

In a letter obtained by Team 5 Investigates, Partners Community HealthCare's Me dical Director, Dr. Thomas Lee, told his colleagues that "physicians will increasingly be rewarded in our pay-for-performance contracts if we increase the percent of generics we use. Increasing our use of generic statins is therefore very much to our advantage."

Former Lipitor patient Genie Holland told Wu, “I'm shocked. They're paying the doctors? Yes. I'm shocked.”

Holland said she was surprised earlier this year when her doctor switched her from Lipitor to a generic version of Zocor without explanation, “because it had worked for me for so long. I also found that my cholesterol went up after I went on the generic.”

But Herzlinger said the medical efficacy is irrelevant to this debate. “You've got to tell the patient that 'I'm switching you to a generic, not only because it's best thing for you and it's going to save you money out-of-pocket, but because I'm going to make more money as a result of that.'”

This is a priceless example of the counterdetailing that the Priesthood of Purists have proposed. It is also going on in the VA where docs are getting cash to prescribe a la ALLHAT. (I wonder if patients are being told of this kickback "specifically.") This is supposedly evidence-based medicine. But where is the evidence that bribing doctors to practice one size fits all medicine is good for the patient?

Soon to follow: cash prizes to get doctors to use recycled and older hip implants, chloroform for surgery, and amputations instead of diabetes care.

http://www.thebostonchannel.com/news/13800173/detail.html
Our friends at the Abigial Alliance "lose" a round in court but sharpen the debate on access to medicines and exposes a glaring weakness in the FDA's -- and Richard Padzur -- argument about why it shoud keep denying dying patients the right to try experimental drugs....

Dying denied right to unapproved drugs
APPEALS COURT SAYS FAMILIES SHOULD ASK CONGRESS TO ACT
By David G. Savage
Los Angeles Times

WASHINGTON - People who are dying do not have the right to obtain unapproved drugs that are potentially life-saving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court in Washington, D.C., ruled Tuesday.

In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

Note the term "wide use." I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur's effort tot take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don't think the Supreme Court is going to let this "wide use" nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.

And let's by clear who the real independent operators are: Padzur is one of those free lancers, along with Graham and the now departed David Ross who acted as a FDA of one under the protection of Waxman and Grassley.

http://www.mercurynews.com/healthandscience/ci_6570788?nclick_check=1
The key to is to give consumers in developing countries -- apart from decent public works -- tools and products that make a daily difference in their lives. Which means getting beyond the attack on capitalism and IP. And it means giving entrepreneurs in developing countries capital, reducing regulatory barriers, and promoting distribution of their products globally. It also means retrofitting design specs for medical products so they are affordable.... A combination of cheesecloth, vinegar and a flashlight can be used to detect cervical cancer. This -- a temporary measure until less expensive pap smears are developed -- can be combined with immunizations to reduce cervical cancer worldwide. For instance:

"Officials are already working on a cheaper version of Merck & Co.'s cervical cancer vaccine Gardasil, which currently costs about $360 per dose. Together with stepped-up screening, doctors think that cervical cancer might one day be wiped out as a major health problem for the developing world. Among the places Gardasil is available are the U.S., Europe, Canada, Australia and New Zealand."

Why use the developing world as a political battleground when such approaches can accomplish so much more?

http://www.chron.com/disp/story.mpl/ap/fn/5025324.html

Raj Rage

  • 08.08.2007
This week's ruling by the Supreme Court of India institutionalizes that incremental innovation in pharmaceuticals isn't important on the sub-continent -- at least when it comes to patent protection..

Many of the usual suspects (Jamie Love, et al.) applaud this decision. But, in reality, it's a horrible blow to global public health -- and particularly to the Third Word, because economically-driven, short-term decisions have deadly unintended consequences.

As Trevor Jones ( a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out relative to treatments for HIV-AIDS:

"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."

The Indian ruling is only the most recent example of how healthcare technology assessment (HTA) aka: evidence-based medicine (EBM) being used to deny not only appropriate patient care, but now case patent protection.

And this is an important link, because minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.

(But large Indian generic manufacturers can make a bundle.)

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits – and members of the Indian Supreme Court.
Article in my hometown (homestate?) paper on consumers who want Vioxx back for various reasons, none of which are good enough for the "true" voice of the consumer, Consumers Union. The condescending tone of the quote from CU's top doc Marvin Lipman is priceless, but then again, when you are an elitist and think most people are idiots easily manipulated by drug companies except (thank goodness) for you, such egotism can be excused:

"These patients argue they -- and not regulators or lawyers -- should decide whether a drug's benefits outweigh its risks, or even whether a drug poses any risks to them at all.

But Marvin Lipman, chief medical adviser for the nonprofit Consumers Union, which has advocated for drug-safety reforms, said such responses, while not unusual, are misguided.

"People do get used to the idea that one drug can help them," Lipman said. "A person's conviction that something is helping them or that only one thing will help them is often erroneous. The impact may be exaggerated."

As opposed to the CU's conviction that the drugs they recommend as Best Buys for Alzheimer's and other drugs are they only things that will help is not erroneous?

http://www.nj.com/starledger/stories/index.ssf?/base/business-7/1186288491133630.xml&coll=1&thispage=2
Maraviroc would be the first personalized medicine for AIDS because Pfizer would first test patients to determine whether the drug works for them....

http://news.yahoo.com/s/nm/20070806/bs_nm/pfizer_hiv_dc
I don't get all the consternation about Peter Rost becoming a journalist as opposed to a blogger. Let the guy make a steady living. At least, unlike others in the media, he makes his viewpoint known, never gets ruffled and is not afraid to fire back when challenged. I don't agree with him but I will look forward to reading him in his new perch. Good luck to the "other" Peter.

http://www.brandweeknrx.com/2007/08/brandweek-shoul.html
Lots of posts about whether drugwonks is, because of our "style" less or more credible than it could be...

Our attacks have never been ad hominem. They have been pointed and backed up by facts and informed by frustration. And unlike many of our critics, we read all of the material we blog on, not just the headlines. We actually do research before we post. And when we are wrong or over the line we apologize openly and honestly.

As for our handling of Steve Nissen, he deserves the Derek Lowe-inspired Kevin Trudeau treatment. As we have said several times on this blog -- and no one else in the pharma blog community seems to care, he and his crony Curt Furberg trashed the cardiovascular safety of ADHD drugs in a most unprofessional fashion. Their attack on Avandia has caused many people to stop taking the drug just as Furberg's frivolous and media orchestrated attack on CCB's caused people to stop taking those drugs 10 years ago.

Drugwonks is the only, the only, site that is consistently shining a light on the relationship between so-called activists like Nissen, Furberg, etc., the medical journals, the media, certain members of Congress the damage they have done to the public health with respect to women's health, depression, ADHD and now diabetes. We have criticized Democrats, Republicans, drug companies, drug ads, conservatives, liberals and even Michael Moore.

Moreover, through CMPI we are coming up with constructive, patient-centric approaches to make medicine more personalized and value-based. What we do on drugwonks is a small part of what we do and who we are. As anyone who attended our Medicine and Media program saw, we have many outlets and seek out many approaches to promote science based medicine. Want to ignore that stuff and focus on what we post that annoys the hell out of you? Be my guest. If that makes us less credible, trust me I won't lose any sleep over it.

We are ticking everybody off it seems. So I guess we are doing something write.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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