Reporting Causes High Blood Pressure...And Lowers It

02/27/2007 12:56 PM |

Some of the worst reporting on health surrounds the relative and absolute risks and benefits about medicines. Case in point is the HPV vaccine. As our friend NYU internist and author Mark Siegel points out, the reason for making the vaccine mandatory has less to do with reducing cancer, important on its own, but also genital herpes, abnormal pap smears and other public health problems...

"The problem with combating the human papilloma virus in the United States isn't only cervical cancer or precancerous cells. The problem also is an epidemic of sexually transmitted genital warts. The CDC says HPV causes more than 6 million new cases of genital warts in this country every year.

There are many cases in medical history where vaccination has proved extremely effective in promoting public health even in the face of possible side effects."
http://www.newsday.com/news/printedition/opinion/ny-opsie205101066feb20,0,3529854.story?coll=ny-opinion-print

The coverage of a recent data dredging effort looking at the RELATIVE RISKS of taking different painkillers and high blood pressures for the most part failed to make the qualifications the researchers did. (This was a study of heavy, obese males in the main who were frequent users of all sorts of pain killers against non users that did not control for any other medications) The increase in risk of 33 percent was an increase in risk from 1 percent to 1.36 percent. Leave to scaremonger at the Washington Post
Shankar Vedantam to write a story with the headline : Doctors Warned About Common Drugs for Pain NSAIDs Tied to Risk of Heart Attack, Stroke... Aargh..

But Seniorjournal.com saves the day with straightforward reporting that just gives the facts without the unscientific spin that shady Shankar always seems to give to his stories:

Older Men Regularly Taking Over-the-Counter Pain Relievers have Risk of High Blood Pressure

http://www.seniorjournal.com/NEWS/Health/2007/7-02-26-OlderMenRegularly.htm  Read More & Comment...

First, do no paperwork

02/27/2007 07:31 AM |

Greek physicians of the Hippocratic period would not treat patients they didn’t think they could “cure.” They believed it was bad for the patient (“First, do no harm”) as well as bad for their reputation. This latter point may seem shocking today, but it was not exceptional in ancient medicine – in fact, it was an integral part of the prognosis process.

When such a situation arose, the ancient Greek physician resigned himself to what was called “noble flight.” (An early example, it should be noted, of health care “spin.”)

But such a thing could never happen today, right?

Well, hopefully – but the current debate over pay-for-performance is re-opening the debate, among many physicians, about the wisdom of accepting difficult to treat patients. What’s old is new again. Consider M&M conferences. While never pleasant, they do serve an important purpose. Now imagine if physicians avoided cases they couldn’t “cure.” Is ignorance really bliss? Can we allow remuneration to trump patient care?

And that's precisely what will happen unless we can more precisely define metrics for pay-for-performance programs that take into consideration multiple variables -- the most important being the individual patient. Otherwise we fall into the morass of so-called evidence-based (read "cost-based') medicine rather than patient-centric care. Saving money by providing anything other than optimum treatment (pharmaceutical and otherwise) is not only penny-wise and pound foolish from an outcomes perspective -- it's also just plain ethically wrong.

Health care isn't a yes/no proposition. The ancient Greeks thought in terms of "cure." Today we think in terms of "treatment." And "treatment certainly isn't binary.

After all, is the ancient Greek fear of damage to one’s reputation really any different than today's fear of reduced payment? We've come too far to stumble on such petty grounds.  Read More & Comment...

The Renal Disease Sweepstakes

02/26/2007 08:54 AM |

The British have always been fond of the Irish Sweepstakes. Unfortunately (and once again) NICE and the NHS are asking patients with kidney disease to play the Renal Disease Sweepstakes.

Should health care really be a crap shoot with terrible odds?

Kidney cancer victims denied "wonder drugs"

The Sunday Times (London) By Daniel Foggo and Sarah-Kate Templeton;
25 February 2007

Two new "wonder drugs" with the potential to prolong the lives of thousands of kidney cancer sufferers are being denied to National Health Service patients because they are too expensive.

The drugs, Sutent and Nexavar, have been shown to shrink tumours dramatically, with some disappearing altogether. Both have been licensed for use in Britain but the NHS has so far declined to issue guidance that trusts should fund the drugs.

Without such guidelines, patients are dependent on the judgment of individual NHS trusts deciding whether or not they can afford the treatment, which costs about £2,500 a month. Some cancer sufferers have been forced to sell their houses or cash in pension schemes to pay for the treatment.

The situation has been likened by doctors to the furore over Herceptin. The breast cancer drug was not routinely prescribed until August last year, following intervention by Patricia Hewitt, the health secretary.

Nicholas James, consultant in clinical oncology at Queen Elizabeth hospital, Birmingham, said of Nexavar: "Patients with this cancer tend to die quite quickly but I know from my own patients who were on the trial how well this drug works. They are still alive two years later."

Despite the enthusiasm of doctors, the National Institute for Health and Clinical Excellence, which draws up the NHS's policies on whether trusts should fund medicines, has so far set no timetable for assessing the two kidney cancer drugs.

As a result, patients can obtain the drugs only through a private doctor or by asking their GP to plead their case individually to primary care trusts (PCTs).

Kidney cancer, which is diagnosed in about 6,600 people each year, has a death rate of more than 50% and is difficult to treat, with both radiotherapy and chemotherapy of little use.

Until the development of Sutent and Nexavar, which both work on the principle of starving tumours of their blood supply, the only viable treatment was the drug interferon alpha.

But in trials of Sutent it was shown to more than double the time tumours remained static in size compared with interferon. Nexavar had similar results.

Professor Robert Hawkins, an oncologist at Christie hospital in Manchester, who conducted a recent Sutent trial, said: "We have had a couple of patients where the cancer seems to have disappeared altogether." At least one patient -- who served in the RAF -- is seeking judicial review over the drug. It was similar action over Herceptin that contributed to its approval as an NHS drug.

Janine Handrick, 35, a travel adviser and mother of five-year-old Madison, is one patient who, with her GP, managed to persuade her PCT in Doncaster, South Yorkshire, to put her on Sutent in December.

"I was diagnosed with cancer last March when they found lumps on my right kidney and in my coccyx," she said. "They removed the kidney but it had spread to my bones and lungs. When the nurse told me they had found tumours, I asked if I would die and she just nodded.

"When my doctor told me they had decided to give Sutent to me, I was ecstatic, although I won't know how effective it is until I have a scan in another six weeks."

Mark Franklin, 39, a builder from Buckinghamshire, was also facing death when he was included in a trial of Sutent last June. The cancer had spread from one kidney, which was removed, to his ribs, lungs, back and other kidney. Now his tumours have shrunk dramatically and this May he plans to climb Britain's three highest mountains.

"There is no doubt I would be dead now if it wasn't for the trial," said Franklin. "Not making this drug available to everyone on the NHS is criminal."

He is one of almost 1,000 signatories so far to an e-petition on the 10 Downing Street website calling on the prime minister to make Sutent and Nexavar freely available.

A spokesman for Kidney Cancer UK said: "These drugs are available in much of Europe and the US but here it is a postcode lottery. We are taking legal advice on whether PCTs can refuse to prescribe these drugs because of cost."

The real saving, in mortality, misery and expense, would come from earlier detection. My cancer, slow-growing and occupying about one-fifth of my left kidney, was detected by ultrasound, which was administered for another reason. This was some ten years before I should have noticed any symptoms, and before the growth could spread to other organs. Partial nephrectomy, with biopsy of a surrounding margin in the operating theatre, was sufficient. I now have one and three-quarters healthy kidneys. Radical nephrectomy will be needed only if my annual ultrasound shows that cancer has recurred in that kidney, and partial nephrectomy is still in reserve for the other side if cancer should be detected there.  Read More & Comment...

Mandatory HPV? Yessiree.

02/26/2007 08:42 AM |

When we disagree with the New York Times editorial page, we say so. Today we strongly agree with their position on mandatory HPV vaccinations. Here's what the Gray Lady has to say ...

A Necessary Vaccine

Debate over a new vaccine to prevent cervical cancer and genital warts has reached a high pitch. State legislatures are debating whether to mandate the vaccine or insist that its use be kept voluntary. The manufacturer stopped a vigorous lobbying campaign lest it provoke more opposition than support. And some health professionals who had been championing the vaccine flinched at making it mandatory, at least for now.

Even so, state legislatures should require that all young girls be given this vaccine, which protects against a virus that causes some 10,000 new cases of cervical cancer in the United States each year — and 3,700 cancer deaths.

Three weeks ago we applauded Gov. Rick Perry for making Texas the first state to require vaccinating young schoolgirls — ages 11 and 12 — against the human papillomavirus. In the ensuing uproar, the Texas House has moved to overturn his order, but the Virginia Legislature has approved a similar mandate. Some 20 states have bills pending to require the vaccinations for school attendance.

We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer. With more than two million doses already distributed, the reported side effects have been mostly minor, such as dizziness or fainting. Many parents who oppose a mandate are aghast at the thought of vaccinating such young girls against a sexually transmitted disease. But the vaccine works only if taken before a girl becomes infected. Social conservatives object that the vaccine will encourage promiscuity, but it seems farfetched to believe that protection from cervical cancer will change any girl’s behavior. Others complain that a mandate will pre-empt parental rights to make health decisions, but all vaccine mandates do that, to protect the children and those they might infect.

The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support.

Merck deserves praise for developing Gardasil at a time when many companies shun the vaccine business as risky and unprofitable. But it is charging $360 for a three-dose regimen, a price that might come down if a competing vaccine enters the market soon, as expected.

The vaccine could prevent thousands of new cases of cervical cancer annually and hundreds of thousands of cases of genital warts and precancerous growths. A mandate would force the health care system to get cracking. And it is the best way to ensure that all children get the vaccine, not just those who are aware of it and can afford it.  Read More & Comment...

T-Shirts Don't Kill

02/24/2007 07:11 AM |

According to Dr. Valerio Reggi, chief of the anticounterfeiting task force created last year by the WHO (and as reported in the New York Times), in many countries, "counterfeiting a T-shirt means 10 years in jail, but counterfeiting a medicine can be a misdemeanor."

A deadly misdemeanor.  Read More & Comment...

Supporting Our Troops

02/23/2007 04:51 PM |

In the wake of the scandal surrounding third world outpatient care for our troops at Walter Reed comes this riposte from prize winning war correspondent Joe Galloway:

Chris Adams's Feb. 9 report that even by its own measures, the Veterans Administration isn't prepared to give returning veterans the care they need to help them overcome destructive, and sometimes fatal, mental health ailments. Nearly 100 VA clinics provided virtually no mental health care in 2005, Adams found, and the average veteran with psychiatric troubles gets about a third fewer visits with specialists today than he would have received a decade ago.

Here's the Chris Adams piece about the VA system pols want to expand to provide drug benefits for us all.
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2003566773&zsection_id=2002107549&slug=vets11&date=20070211
I want Ron Pollack to be the first one to enroll himself and his family

Mrs Clinton and her followers should be next...
Contrast this with Hillary's bubbly view of the VA -- her shining model for national health care since her last iteration, regional health gulags, crashed and burned...."The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning. The other thing the VA has done to keep costs down is negotiate for drug prices with the drug companies."  Read More & Comment...

Good Article But Selective Reporting?

02/23/2007 08:59 AM |

Marilyn Chase had an good piece in the WSJ about how doctors and consumers have driven the debate over whether to use Avastin off label to treat macular degeneration for about $40 a dose or the drug Genentech developed for the disease and for which it received FDA approval. Lucentis is administered in the form of smaller molecules, which is thought to give Lucentis an advantage over Avastin in its ability to penetrate the eye's retina and halt abnormal blood vessel growth contributing to advanced macular degeneration and scarring that causes blindness. But opthamologists think otherwise. They began using Avastin as a placeholder while Lucentis was being developed and have stuck with it because it is cheaper and see no reason to change. Now the NIH is seeking to conduct a head to head trial which, if it goes the way of all large scale trials,will show no difference except in terms of side effects which is a huge exception since it relates directly to individual response to doses. And that is something that Judah Folkman observed in the Phase I trials of Avastin way back when but back then the FDA insisted everyone had to get the same dose.

So the head to head trial is really a product of one size fits all science, not Genentech's evil effort to milk profit out of Avastin, For perspective, note that in it's recent study to determine the effectiveness of Avastin in lung cancer, Genentech found that a smaller dose was as effective as a higher dose. It would behoove Genenetch and those who are setting up the Lucentis trial as a sentinel event for government run comparative effectiveness research to look at which patients do best at which dose and molecule size. That's where medicine is heading. And if we want to avoid across the board reimbursement decisions that drive one size fits all medicine, Genentech and other companies are going to have to get ahead of the curve as it did with Avastin in lung cancer. It must change the conversation with consumers and doctors by giving them different and better information.

As it can see (no pun intended), the media will not do it for them....

Genentech's Big Drug For Eyes Faces a Rival  Read More & Comment...

Japan's Cancer Refugees

02/23/2007 07:09 AM |

At first glance, Japan's health-care system seems superior to America's. Its infant mortality rate is among the world's lowest. Japan's life expectancy is the world's highest for women (85.6 years) and the fourth-highest for men (80.4 years).

All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.

Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:

http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm

A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.

Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.

Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.  Read More & Comment...

Evidence-Based Medicine? G'Day Mate

02/22/2007 07:14 AM |

Recently I spoke at a joint California Healthcare Institute/Pacific Research Institute conference on evidence-based medicine -- with a particular focus on how it isn't working all that well Down Under, and a few important lessons we should learn from the Aussie experience.

Here's a video podcast of my remarks:

http://sys-con.com/read/340224.htm

Enjoy.  Read More & Comment...

Why Blog When Someone Else Will Do It For You

02/21/2007 10:29 PM |

Here's Derek Lowe of pipeline.Corante.com blogging about his take of our first Media and Medical Science conference.... Derek talks like he writes, witty, unvarnished and informative ...

In The Pipeline

We had wonderful attendance, great moderators and panelists, including another first time blogger, Ed Silverman who just launched http://www.pharmalot.com

Can I get away with just saying that 1. coverage does drive policy and that the more science based the coverage, the better the policy and 2. everyone that has skin in the game has an obligation to, in the words of Greg Simon, "stop whining (which he said with a smile) and start working to change the conversation" 3. everyone needs to do a better job explaining what drug and biotech companies do.

Key words.... consumerism, transparency, honesty, benefits, skepticism (on the part of the media ) biomarkers.  Read More & Comment...

Medicine and the Media

02/21/2007 06:10 AM |

Today CMPI is hosting "Medicine and the Media: Redefining Roles and Responsibilities." If you can't make it to DC for this event (and we hope you can), please join us via audio webcast. Sign-up information can be found by clicking on the link below:

http://www.visualwebcaster.com/Stratosphere/37936/reg.html

And if you can't join us for the whole day, please be sure not to miss FDA Commissioner von Eschenbach's lunchtime speech on "FDA and the Media."

Hope you can join us.  Read More & Comment...

Baht on a Hot Tin Roof

02/20/2007 03:42 PM |

Imagine a world without intellectual property protection. Now stop imagining and start paying attention to what's going on in Thailand.

Have a look at this new op-ed in today's Baltimore Sun ...

http://www.baltimoresun.com/news/opinion/oped/bal-op.patents20feb20,0,89958.story?coll=bal-oped-headlines

... and let's talk.  Read More & Comment...

We're The Good Guys!!!

02/20/2007 10:01 AM |

In light of the pro-generic tilt of public policy these days the following sidebar from the Pharmaceutical Business Review might be of interest:

Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.

It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.

Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."

Ouch.

Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...

This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...

And these are the good guys Waxman, Love and co are supporting.  Read More & Comment...

Biotech As a Source of Wealth Redistribution

02/19/2007 09:38 PM |

Follow on biologics (generic biologics) will be a safe scientific fact of life in the near future. But that's not fast enough for Congressional Democrats who want to use the biotech industry as a source of income redistribution and a cash cow for expanding SCHIP. So it has turned to Bill Haddad, an individual who is the godfather of the Hatch-Waxman act and whose company Biogenerics, stands to profit from the creation of FDA approval of generic biotech medicines to write the legislation for followon biologics. In its current form it is sweetheart deal for generics firm: No testing requirements, no postmarket studies, just show up with the files from the innovator company and your own brew. As for the $70 billion in savings, which just coincidentally equals the amount needed to fund the SCHIP expansion, Dems have turned to the PBM trade group -- which will profit from early termination of biotech patent -- to come up with projections of how much cash will be saved by swiitching patienets to knockoffs.

Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.  Read More & Comment...

What's the Most Important FDA Goal?

02/19/2007 09:36 PM |

Protecting people against disease or the drugs that are developed to treat the illnesses in the first place?  Read More & Comment...

Even Safety Needs Limits

02/19/2007 12:42 PM |

Here's a new article (by me) from this week's edition of Barron's. The title says it all, "Even Safety Needs Limits."

To read the article, click on the link below:

Download file

To entice you on, here's the closing paragraph:

"FDA decisions can be made more transparent to all interested parties. The agency can improve cooperation with the industry, patient groups, physicians, hospitals, academia, and other government agencies. The goal should not be conducting more time-consuming discussion, but finding more effective ways to bring medical advances to patients as quickly as possible."  Read More & Comment...

Der Blaue Engel

02/17/2007 12:26 PM |

From today's edition of the Boston Globe, our rebuttal to Marcia Angell's most recent me-too mania:

Similar drugs, but world of difference

Take away message: There is no such thing as a "me-too" drug" because there is no such thing as a "me-too" patient.  Read More & Comment...

Greek Ruins

02/17/2007 10:48 AM |

FDA Warns of Wrong Drugs
Being Sold Over the Internet
Associated Press

February 16, 2007 6:03 p.m.

Consumers who thought they were purchasing sleep aids, antidepressants and other drugs over the Internet instead were shipped a powerful antipsychotic, sending some unwitting victims to the emergency room, federal health officials warned Friday.

The Food and Drug Administration said a number of consumers took the schizophrenia drug, haloperidol, after being shipped what they thought were a variety of different pills, including Ambien, a sleep aid, and the anti-anxiety medications Xanax and Ativan. Others thought they were getting the antidepressant Lexapro.

Preliminary analysis of the pills, packaged in plain plastic bags and mailed in envelopes bearing Greek postmarks, suggest they contain haloperidol. The
FDA said it had reports of several consumers seeking emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after taking the pills.

The FDA used the occasion to remind consumers of the possible dangers of buying prescription drugs on the Web.

The FDA posted images of the suspect pills and their shipping packages on its Web site to help consumers identify any suspect product they may have ordered.

Consumers apparently ordered the drugs through a variety of commercial Web sites. The FDA said it was investigating.  Read More & Comment...

Nobel Prize Winner Endorses Part D

02/16/2007 12:00 PM |

We have been saying this all along.

Part D is working...drugs save money in the long run. Giving people choices to steer dollars to in ways that actually prevent disease (more drugs, newer drugs, better drugs) is a great investment.

It doesn't take a Nobel Prize economist to say that (some like Joe Stiglitz still can't figure it out) but it's great when they do.

http://online.wsj.com/article/SB117159975453110920.html?mod=opinion_main_commentaries  Read More & Comment...

Novartis' Dignified Response to NGO Nonsense

02/16/2007 08:54 AM |

A courageous interview with Paul Herring, head of corporate research for Novartis, regarding India's denial of a patent for Gleevec... A case study why more companies should get more scientists to speak out about the savaging of their industry by junta loving NGOs...


We are Not Doing This Out of Spite’
The Business World (India)


India, 2/16/2007 - In a case that has got the world’s attention, Swiss multinational Novartis AG has challenged the Indian Patent Office’s decision to deny it a patent on cancer drug Glivec, in the Madras High Court. Novartis has also questioned provisions in the Indian Patent Act under which the patent was denied (under these provisions, incremental improvements to existing drugs cannot be patented). The $37-billion drug maker, best known here for Calcium Sandoz and pain-killer Voveran, had earlier won an exclusive marketing right— now lapsed — on Glivec in India. With its patent claim rejected, cheaper copies of Gli-vec are free to sell in the Indian market. The lawsuit has drawn the ire of humanitarian organisations such as Medicins Sans Frontieres (MSF) and Cancer Patients’ Aid Association (CPAA) for its potential to deny these cheaper generics to patients and for its possible impact on the Indian Patent Act, which currently restricts patenting to completely new drugs. Recently, a quarter of a million people signed a petition demanding that Novartis drop the case. Activists have held protests against the company in India and Switzerland. The backlash is reminiscent of a time, not too long ago, when 39 multinationals, including Novartis, sued the South African government to drop certain provisions in its law that governed access to medicines that the companies thought threatened their patents. Those companies were eventually forced to withdraw the lawsuit. Will this case go the same way? Paul Herrling, Novartis’ head of corporate research, who is also in charge of the Singapore-based Novartis Institute for Tropical Diseases, was in India for a day to address members of a business association. In an interview with BW’s Gauri Kamath, Herrling explains why Novartis is fighting tooth and nail for a case that is, no doubt, causing great harm to its public image.

Your visit is against the backdrop of the Glivec lawsuit. Any comments?
Fundamentally, this is about patents. And I am in research. Our view in research is that patents save lives. You need to invest for 15 years to translate a scientific idea into a breakthrough medicine such as Glivec. Nobody could or would do that kind of research if there was not a hope to recover the investment at the end of the day.

Do you think that the price that you have paid in terms of your public image is worth this patent that you might get if you win?
It is a problem that so many people are upset. We do not want to be seen the way we are being portrayed. One of the leaders of this petition against us is MSF. As you may also know, I am the chairman of the Novartis Institute for Tropical Diseases in Singapore that makes drugs against tuberculosis, dengue and malaria for patients in poor countries — which we will sell at no profit. I work with many people from MSF on projects. And, they are actually wonderful people. But they were never into drug discovery. They do not know the conditions that are needed to make a new drug. They think if one would weaken or abolish patents, then the problem of access for medicines would be solved. This is wrong. I do not think the patent issue is nowadays a major impediment to making drugs available. Novartis has the world’s best malaria drug— Coartem— which is a joint project with Chinese scientists. We give it at no profit, and in 2006 we delivered 62 million treatments, which make it the biggest selling Novartis drug ever. The reason why we can do this is because we have enough business in markets where people can afford (to pay more for) it. This enables us to allocate some of our earnings to access-to-medicine projects where we have life-saving drugs. And the same happens with Glivec in India. As much as 99 per cent of all the Glivec in India is given for free. So, patents have not prevented access, it is how you use them. We have patents on Coartem and there are companies that are now copying it and selling it. We have never done anything to stop them from doing it.

This case really is not about whether India respects product patents per se. It is challenging certain provisions that define what can be patented and what cannot.
The amendments (to the patent law) undermine a significant aspect of patents. They say if it is essentially the same idea and you make improvements on it, then you cannot patent it. But that is not the way science works. For example, children with thalassemia need a lot of blood transfusions. When you do frequent transfusions, iron accumulates in your body which could eventually ruin the liver. We had a drug that was able to take the iron back out of the blood, but it had to be given in continuous intravenous infusion. That meant these children had to have a pump, that was bigger than a cellular phone, on them all day and a needle that was going into one of their veins. So, here what would be considered an incremental innovation(under the Indian law) was to find a version of this drug that children could take as a pill. Under the current amendment, this would not get patent protection, which in turn means nobody would invest because when you do this new version you still have to do all the safety studies and prove that, in fact, the effect is the same.

What is the issue with the patent application on Glivec?
There are two aspects. In Glivec’s case, the issue is a new form of the drug. So, the active ingredient is the same and the salt is different. And we have seen that the absorption of this is better than the original. It is true that the original patent with the original salt form could not be granted for a technical reason because everything before 1995 could not. In this case, we patented this new salt form in 40 countries because we had evidence from our experiments that this would make it easier to absorb, which again means better levels in the body, less variability in the effect. So, that’s again an advantage to the patient. Now, India says, no, you are not going to patent that until you have proven in people that this really translates into the advantage that you foresee from animal studies. Patents (all over the world) are normally given at a time when a scientist can document any invention — a molecule in this case — and some of its effects. In this case, it was through animal experiments, solubility experiments and so on. Once I get the patent at this point —which is early in its life — then I invest. If I am being told that I have to first invest hundreds of millions, and then maybe I can get a patent, then I do not invest. That is the other issue.

Then, in this particular case, would Novartis be willing to do those human studies just to make a point?
Such studies are happening all over the world.

So, you have that supporting documentation.
No. Because that takes time to do.

Is there a point beyond which you don’t believe that this particular case is worth fighting for?
It is difficult to say what the future will look like. If we had solved 99 per cent of all the medical problems on this planet, we would not fight that much. Then there would not be any need for any new drugs and we would sell the old ones, fine. But the big problems are not solved. We believe if the system were to be undermined, it would not be to the advantage of humanity in general.

Does the rejection of the patent on Glivec, or the way people have broadly reacted to the lawsuit, affect your R&D investments or collaborations in India in any way?
Yes. When I was asked why we created our research institute in Singapore, not in India, which also has the talent, the same diseases and so on, that is the reason. We have announced the creation of a major research institute in Shanghai. There we see that it’s not perfect but the system is in place to get to a better and better improvement of intellectual properties.

What about the R&D collaborations that you already have?
They are successful, but because of this intellectual property (IP) insecurity we are not doing chemistry that leads directly to a potential medicine but only supportive work. If this point would be clarified in the positive, we could expand it. Then there would be no difference in the collaborations we do in India versus the US, China or any other place.

But not investing in a country just because of IP issues is like throwing the baby out with the bathwater. Just because pirated copies of Windows Vista sell in China, you don’t see Bill Gates saying he is going to stop investing there. The economics overrides everything else.

I cannot judge the computer industry at all.

There, too, it is the IP issue.
We are talking about other things here. We are talking about products that potentially save lives. And in contrast to the IT industry, we are the most regulated industry on this planet. And the investment level that you have to have for each product is such that we have to look at the world and decide where are the best conditions (to invest).

Is there any attempt to meet with the government?
Oh, no. The courts will decide and we do not want to interfere with this process at all. But what we do is talk to you. It is very vital to us that people understand that we are not doing this out of spite. And we just want to explain our view to people who hear only one side in the press because NGOs are very vocal.  Read More & Comment...